U.S. patent application number 13/932152 was filed with the patent office on 2013-11-07 for color coded guide wire and methods of making same.
The applicant listed for this patent is ABBOTT LABORATORIES. Invention is credited to Michelle E. Alexander, Emmanuel C. Biagtan, Pablito Buan, David H. Burkett, Wayne E. Cornish, Carl P. Frick, John J. Nelson, Robert J. Peralta, Jessica M. Saenz, John A. Simpson, Arthur R. Tyre, Travis R. Yribarren.
Application Number | 20130292365 13/932152 |
Document ID | / |
Family ID | 45807410 |
Filed Date | 2013-11-07 |
United States Patent
Application |
20130292365 |
Kind Code |
A1 |
Cornish; Wayne E. ; et
al. |
November 7, 2013 |
COLOR CODED GUIDE WIRE AND METHODS OF MAKING SAME
Abstract
A color coding is applied to medical guide wires by coloring
portions of the guide wire to distinguish similar guide wires and
guide wire portions from a particular manufacturer. The metallic
elongate core can be colored using various methods such as
electrochemical processes, sputtering, electroplating, and laser
inducing microstructures to alter the surface characteristics of
the elongate metallic core. Alternatively, the outer layer of the
guide wire can be color coded by using non-standard colors or by
introducing a colored band on the guide wire.
Inventors: |
Cornish; Wayne E.;
(Fallbrook, CA) ; Yribarren; Travis R.; (Campbell,
CA) ; Frick; Carl P.; (Laramie, WY) ; Saenz;
Jessica M.; (Lake Elsinore, CA) ; Biagtan; Emmanuel
C.; (Temecula, CA) ; Buan; Pablito; (Temecula,
CA) ; Burkett; David H.; (Temecula, CA) ;
Nelson; John J.; (Carlsbad, CA) ; Peralta; Robert
J.; (Murrieta, CA) ; Alexander; Michelle E.;
(Murrieta, CA) ; Tyre; Arthur R.; (Murrieta,
CA) ; Simpson; John A.; (Carlsbad, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBOTT LABORATORIES |
Santa Clara |
CA |
US |
|
|
Family ID: |
45807410 |
Appl. No.: |
13/932152 |
Filed: |
July 1, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12880465 |
Sep 13, 2010 |
8480597 |
|
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13932152 |
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Current U.S.
Class: |
219/121.72 ;
156/153; 156/60; 29/426.1; 29/428; 29/458 |
Current CPC
Class: |
A61M 2025/09108
20130101; A61M 2025/09133 20130101; Y10T 29/49815 20150115; A61M
25/09 20130101; Y10T 29/49826 20150115; Y10T 29/49885 20150115;
A61M 2025/0008 20130101; Y10T 156/10 20150115 |
Class at
Publication: |
219/121.72 ;
29/428; 29/426.1; 29/458; 156/60; 156/153 |
International
Class: |
A61M 25/09 20060101
A61M025/09 |
Claims
1-39. (canceled)
40. A method of color coding a guide wire for use in a medical
procedure having an elongate metallic core member, a flexible
distal end, and a low friction outer coating, comprising: attaching
a colored band to the guide wire at a proximal end of the guide
wire.
41. The method of color coding a guide wire of claim 40, further
comprising applying an extruded polymer onto the guide wire to form
the colored band.
42. The method of color coding a guide wire of claim 41, further
comprising removing a portion of the low friction outer coating to
create a void, and then applying the colored extruded polymer band
at the void where the low friction outer coating was removed.
43. The method of color coding a guide wire of claim 41, wherein
the colored polymer is selected from a group comprising
melt-processable fluoropolymers and polyurethanes.
44. The method of color coding a guide wire of claim 41, wherein
the color of the band is selected from a group comprising white,
blue, yellow, gold, and teal.
45. The method of color coding a guide wire of claim 41, further
comprising removing a portion of the low friction outer coating
with a laser.
46. The method of color coding a guide wire of claim 41, further
comprising roughening a surface of the elongate core member to
yield a better surface for adhesion with the extruded colored
band.
47. The method of color coding a guide wire of claim 41, further
comprising applying a layer of silane to the elongate core member
prior to applying the colored extruded polymer band.
48. The method of color coding a guide wire of claim 41, further
comprising applying a layer of adhesive to the elongate core member
prior to applying the colored extruded polymer band.
49. The method of color coding a guide wire of claim 41, further
comprising reducing a diameter of the elongate core member at a
position where the color colored band is to be located.
50. The method of color coding a guide wire of claim 41, further
comprising grinding the elongate core member to include a taper for
enhancing adhesion of the colored band with the elongate core
member,
51. The method of color coding a guide wire of claim 41, further
comprising removing the guide wire from an extrusion apparatus once
a desired length of polymer is extruded onto the guide wire.
52. The method of color coding a guide wire of claim 41, further
comprising applying a lubricious coating to the colored band to
minimize friction with a catheter.
53. A method of color coding a guide wire used for a medical
procedure having a metallic core member, a flexible distal end, and
a low friction outer coating, comprising: applying a laser to the
elongate core member to form microstructures on a surface of the
metallic core member, where a type and number of microstructures
determines a color of the metallic core member.
54. The method of claim 53, where the laser is a femtosecond
laser.
55-66. (canceled)
Description
BACKGROUND
[0001] This invention relates to the field of guide wires for
advancing intraluminal devices such as stent delivery catheters,
balloon dilatation catheters, atherectomy catheters and the like
within a patient's body, such as within a patient's
vasculature.
[0002] In a typical percutaneous procedure in a patient's coronary
system, a guiding catheter having a preformed distal tip is
percutaneously introduced into a patient's peripheral artery, e.g.
femoral, radial or brachial artery, by means of 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. There are two basic techniques for advancing a guide wire
into the desired location within the patient's coronary anatomy,
the first is a preload technique which is used primarily for
over-the-wire (OTW) devices and the bare wire technique which is
used primarily for rail type systems. With the preload technique, a
guide wire is positioned within an inner lumen of an OTW device
such as a dilatation catheter or stent delivery catheter with the
distal tip of the guide wire just proximal to the distal tip of the
catheter and then both are advanced through the guiding catheter to
the distal end thereof. The guide wire is first advanced out of the
distal end of the guiding catheter into the patient's coronary
vasculature until the distal end of the guide wire crosses the
arterial location where the interventional procedure is to be
performed, e.g. a lesion to be dilated or a dilated region where a
stent is to be deployed.
[0003] The catheter, which is slideably mounted onto the guide
wire, is advanced out of the guiding catheter into the patient's
coronary anatomy over the previously introduced guide wire until
the operative portion of the intravascular device, e.g. the balloon
of a dilatation or a stent delivery catheter, is positioned across
the arterial location. Once the catheter is in position with the
operative means located within the desired arterial location, the
interventional procedure is performed. The catheter can then be
removed from the patient over the guide wire. Usually, the guide
wire is left in place for a period of time after the procedure is
completed to ensure re-access to the arterial location if it is
necessary. For example, in the event of arterial blockage due to
dissected lining collapse, a rapid exchange type perfusion balloon
catheter such as described and claimed in U.S. Pat. No. 5,516,336
(McInnes et al.), can be advanced over the in-place guide wire so
that the balloon can be inflated to open up the arterial passageway
and allow blood to perfuse through the distal section of the
catheter to a distal location until the dissection is reattached to
the arterial wall by natural healing.
[0004] With the bare wire technique, the guide wire is first
advanced by itself through the guiding catheter until the distal
tip of the guide wire extends beyond the arterial location where
the procedure is to be performed. Then a rail type catheter, such
as described in U.S. Pat. No. 5,061,273 (Yock) and the previously
discussed McInnes et al. which are incorporated herein by
reference, is mounted onto the proximal portion of the guide wire
that extends out of the proximal end of the guiding catheter
outside of the patient. The catheter is advanced over the guide
wire, while the position of the guide wire is fixed, until the
operative means on the rail type catheter is disposed within the
arterial location where the procedure is to be performed. After the
procedure the intravascular device may be withdrawn from the
patient over the guide wire or the guide wire advanced further
within the coronary anatomy for an additional procedure.
[0005] Conventional guide wires for angioplasty, stent delivery,
atherectomy 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 or a
tubular body of polymeric material disposed about the distal
portion of the core member. A shapeable member, which may be the
distal extremity of the core member or a separate shaping ribbon
secured to the distal extremity of the core member, extends through
the flexible body and is secured to the distal end of the flexible
body by soldering, brazing or welding which forms a rounded distal
tip. Torquing means are provided on the proximal end of the core
member to rotate, and thereby steer, the guide wire while it is
being advanced through a patient's vascular system.
[0006] Further details of guide wires, and devices associated
therewith for various interventional procedures can be found in
U.S. Pat. No. 4,748,986 (Morrison et al.); U.S. Pat. No. 4,538,622
(Samson et al.): U.S. Pat. No. 5,135,503 (Abrams); U.S. Pat. No.
5,341,818 (Abrams et al.); U.S. Pat. No. 5,345,945 (Hodgson, et
al.) and U.S. Pat. No. 5,636,641 (Fariabi) which are hereby
incorporated herein in their entirety by reference thereto.
[0007] Guide wires are typically designed for specific applications
that call for varying stiffness, diameter, lubricity, tactile
feedback, and lengths. However, there is little in the way of
distinguishing characteristics between different guide wires,
particularly those with a stainless steel core and a standard
polymer body. The structure and design of guide wires results in a
similarity in the appearance of substantially all models and brands
of guide wires. This makes it difficult to establish brand
recognition among guide wire manufacturers and presents problems
when selecting guide wires for a particular purpose since they all
appear alike. For example, in a bifurcation stent delivery
procedure, it is common for the physician to place one guide wire
within the side branch of the bifurcation and another guide wire
within the main branch of the bifurcation. In such circumstances,
it is customary for the physician to use some personal method of
distinguishing the guide wires, such as always placing the side
guide wire to the right of the main guide wire, placing a cloth on
one guidewire as a marker, or another similar methodology. This
personal methodology is susceptible to error. Furthermore,
distinguishing brand recognition is difficult in this market since
most guide wires appear similar, even if performance differs from
manufacturer to manufacturer.
SUMMARY OF THE INVENTION
[0008] The present invention seeks to overcome the shortcomings of
the indistinguishable appearance of guide wires by constructing a
system and method for color coding various guide wires to
distinguish one mode or brand from another. In a first embodiment
of the present invention, the guide wire core is subjected to a
coloring process such as electrochemically altering the color of
the steel core to produce a steel core having a distinct hue.
Electrochemical processes can produce gold, bronze, purple, blue,
red, black, and green surfaces on the core of the guide wire. The
stainless steel wire is immersed in a heated acid bath and
electrical current is applied, thereby thickening the transparent
chromium oxide film. This has the dual effect of protecting the
stainless steel core from oxidation and corrosion, and also alters
the way light is reflected by the surface. A full spectrum of
colors are available, and the colors will not fade. The guide wire
can be colored with or without a PTFE coating, and a silicone-based
protective layer can be applied over the colored core to enhance
lubricity. Where a PTFE coating is applied, the coating can be
transparent to reveal the underlying colored core section of the
guide wire, or the PTFE coating can be opaque and applied in
sections to reveal windows or sections of the color coded core. The
color coded sections or windows can also be used as markers along
the guide wire to assist with the placement of the guide wire. The
electrochemical process can be applied prior to assembly of the
guide wire, or it can be applied to a selected portion of a fully
constructed guide wire assembly. Alternatively, the guide wire can
be coded with PTFE with a non-standard color such as white, blue,
yellow or gold among other colors. In this manner, the PTFE coating
can be used to color code the guide wires. The PTFE coating may be
applied from either a spray process where designated sections can
be easily masked to coat the exterior with one or more designated
colors, or a continuous reel-to-reel coating process can be
used.
[0009] In another embodiment of the present invention, a colored
band is positioned on the guide wire between the PTFE location and
a proximal docking extension. This colored band can be any desired
length, with a preferred length between 1 to 20 centimeters. The
band can be applied by one of many processes, including an
extrusion process of applying a thin coating onto a non-continuous
length of wire. For example, a colored polymer with high adhesion
characteristics to stainless steel is extruded onto a selected
section of the guide wire, where the polymer is of a color that
particularly stands out from standard green PTFE, such as white,
yellow, gold, or teal. A laser treatment can be applied to the
guide wire prior to the extrusion process to remove a portion of
the PTFE, and then a polishing or grinding process may be used to
roughen the surface of the bare wire core for better adhesion. A
silane coating may also be applied to further promote polymer
adhesion. Choice of polymers can include, but are not limited to,
melt-processable fluropolymers and polyurethanes. In an alternative
embodiment, an extrusion die assembly may be modified so that the
molten polymer flows into a cavity between the die and the wire
core. Once cooled, the guide wire is removed from the extrusion
assembly.
[0010] In another embodiment of the present invention, a guide wire
is color coded by applying an ultra-short, intense laser beam (e.g.
femtosecond laser) that forms nanostructures on the guide wire. The
nanostructures absorb and reflect light differently than the core
guide wire material, thereby producing a colored guide wire
section. The laser forms nanostructures such as pits, globules, and
strands that modify the material's optical characteristics.
Variation of the laser's intensity, pulse length, and number of
pulses can control the size and shape of these nanostructures, and
thus how they reflect light. Metals with a silver appearance can be
modified to appear gold, iridescent, and other colors.
[0011] In another embodiment, a guide wire assembly includes a
guide wire having a tapered proximal end for receiving a color
coded tubular sleeve that slides over the tapered portion and is
removably lodged onto the tapered section. In this embodiment, the
guide wire typically is used with a dock extension wire and has a
undulating wire at its proximal end that has been formed by
grinding the proximal section of the guide wire. The undulating
portion, sometimes referred to as a "coined" portion, has an
undulating structure that gradually tapers to the core wire
diameter, typically 0.3556 mm (0.014 inch). Other guide wire
diameters also are contemplated. Further, the color coded tubular
sleeve slides over the undulating portion or coined portion of the
guide wire and firmly lodges onto the tapered portion of the
proximal end of the guide wire. No other adhesive or laser welding
is required to removably attach the tubular sleeve onto the tapered
portion. In use, when two guide wires are used simultaneously in a
patient, the physician will simply remove one of the color coded
tubular sleeves by pinching the tubular sleeve with his/her fingers
and pulling the tubular sleeve proximally off of the tapered
portion of the proximal end of the guide wire. Thus, the physician
can distinguish between the two guide wires since one will have no
color coded tubular sleeve, while the other guide wire still has a
color coded tubular sleeve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a perspective view, partially cut away, of an
embodiment of a guide wire of the present invention.
[0013] FIG. 2 is a cross-sectional view of the guide wire of FIG. 1
taken along lines 2-2.
[0014] FIG. 3 is a cross-sectional view of the guide wire of FIG. 1
taken along lines 3-3.
[0015] FIG. 4 is an elevated perspective view of a guide wire
immersed into and extracted from an electrochemical solution.
[0016] FIG. 5 is a perspective view of a guide wire having a
colored core.
[0017] FIG. 6 is an elevated perspective view of a guide wire
subjected to a spraying process.
[0018] FIG. 7 is a perspective view of another embodiment of the
present invention having a colored band at a proximal end.
[0019] FIGS. 8a and 8b are an elevated perspective view of a laser
process for creating nanostructures to a banded surface of a guide
wire.
[0020] FIG. 9 is a cross-sectional view depicting a color coded
tubular sleeve.
[0021] FIG. 10 is a perspective view of a guide wire and a color
coded tubular sleeve to be mounted on the guide wire.
[0022] FIG. 11 is a perspective view, partially in section, of a
tubular sleeve sliding over the proximal end of a guide wire.
[0023] FIG. 12 is a perspective view, partially in section,
depicting a color coded tubular sleeve lodged onto the proximal end
of a guide wire.
[0024] FIG. 13 is a perspective view, partially in section,
depicting a color coded tubular sleeve lodged onto the proximal
portion of a guide wire.
[0025] FIG. 14 is a perspective view, partially in section,
depicting a tubular sleeve lodged onto the proximal portion of a
guide wire.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0026] The present invention is directed to an elongated
intracorporeal device such as a guide wire having a color coding
system. The color coding distinguishes similar guide wires for use
in procedures where multiple guide wires are used as well as
helping to select an appropriate guide wire for a single guide wire
procedure. The color coding can also be used for brand recognition
to distinguish one manufacturer from another. In various
embodiments, the color coding can be applied to the metal core,
either at a distal or proximal end, or to a flexible outer body
portion of the guide wire. Various methods for implementing the
color coding of the guide wires are set forth below, and the
description of the color coding methods are intended to be
illustrative but not limiting.
[0027] FIG. 1 is a side elevational view partially in section of
one embodiment of the present invention guide wire 10. The guide
wire 10 includes an elongated core having a proximal core section
12 and a distal core section 14. In this embodiment, the entire
wire core is made from a single material such as stainless steel.
In various alternative embodiments (not shown), the proximal core
section can be made from a high strength steel while the distal
core section 14 is made from a superelastic alloy such as
nickel-titanium (e.g., Nitinol) or the like. The two core sections
can be joined by a weld or adhesive, and/or by an interconnecting
hypotube made from various materials.
[0028] Returning to FIG. 1, the guide wire 10 includes optional
tapered sections 16, 18. Specifically, the present invention
contemplates one or more tapered profiles at varying degrees of
taper, although straight, curved, and/or stepped profiles are also
contemplated. The guide wire 10 further includes a coating 20
disposed on and adhering to the wire core 22. The surface coating
20 or the surface of the wire core 22, or both, include color
coding as discussed below.
[0029] The surface coating 20 may only partially cover the guide
wire core 22 or may envelope the entire core altogether. The
surface coating may be a low friction material such as
polytetrafluoroethylene ("PTFE") that aids in positioning the guide
wire 10. The coating may include positional markers 36 at the
distal or proximal end to aid the practitioner in locating the end
portion(s) of the guide wire 10. Toward the distal end 24 of the
guide wire 10 is typically a flexible member 26. Preferably the
flexible member 26 is one or more helical coils welded, bonded,
soldered, or otherwise attached to the distal core section 14. In a
preferred embodiment, the flexible member is made of a radiopaque
material such as platinum to help provide accurate positioning of
the guide wire. In the embodiment shown, the flexible member 26 is
attached at its proximal end by a weld or solder mass 28 and at its
distal end by a solder ball 30 or similar rounded tip. Furthermore,
the guide wire 10 features a flattened distal tip 32 that extends
into the solder ball 30. FIGS. 2 and 3 are cross-sectional views of
the guide wire 10 taken along lines 2-2 and 3-3 of FIG. 1,
respectively.
[0030] FIG. 4 shows a process in which a guide wire 100 is
submerged into a container 110 having an electrochemical solution
120 therein to impart a color to the stainless steel core of the
wire. It is known that stainless steel can be colored by
electrochemical bathing, as well as sputtering, electroplating, and
paints. In electrochemical bathing, the metal is immersed in a hot
acid solution and an electrical current is applied. This thickens
the transparent chromium oxide film that makes stainless steel
corrosion resistant, and also changes the way light is reflected by
the surface of the metal. By varying the length of the bath, the
amount of current supplied, and the acidity of the solution, a full
spectrum of colors may be manifested including but not limited to
gold, bronze, purple, blue, red, black, and green. The color will
not fade and can be applied uniformly or varied for a rainbow
effect. The color can also be selectively removed by etching,
polishing or engraving.
[0031] The wire 100a after being removed from the electrochemical
solution 120 has its appearance changed from the silver color of
stainless steel to another color. Exemplary colors include bronze,
purple, blue, red, black, or green. The wire 100a can then be
incorporated into a guide wire 10a (FIG. 5) by applying a flexible
polymer coating 20 onto the wire such as PTFE, where the proximal
150 and distal 160 ends of the guide wire reflect the colored wire
core. The PTFE coating can be applied to the entire wire core 100a,
or it can be applied to all but a proximal 5 to 20 centimeters of
the wire core, leaving a portion 170 of the colored wire core
exposed for easy identification and differentiation. In addition,
by careful removal of the PTFE coating the colored wire core can be
used as the markers 180 along the guide wire 10a. Alternatively,
the guide wire can be assembled first and then the electrochemical
process is applied to only the proximal end 170 of an exposed
portion of wire core 100a, coloring only the exposed proximal end.
The color wire core can alternatively be cut into 1 to 10
centimeter lengths and attached to the proximal end of an untreated
wire core. A silicone-based film may preferably be applied to
enhance lubricity before the coating is applied. In addition to the
change in appearance of the guide wire due to the electrochemical
process, the thickening of the chromium oxide film increases the
resistance to corrosion in the colored wire.
[0032] In a second embodiment of the invention, the PTFE coating
that is applied to the colored wire 100a is transparent, such that
the colored wire 100a can be viewed through the PTFE coating. The
underlying colored wire is visible through the transparent coating
for the length of the guide wire while the low friction properties
of the PTFE coating are preserved. In each embodiment, a set of
guide wires can be created with a spectrum of colors to distinguish
different types of guide wires, or to distinguish otherwise similar
guide wires from each other using the colored wire core.
[0033] As an alternative to electrochemical bathing, the wire core
can be colored by plasma vapor deposition or sputtering. This
process typically applies a very thin, colored ceramic or metallic
coating to the surface of the wire core. A variety of colors can be
obtained, including gold, black, blue, red, rose gold, silver gold,
and brass. The color is stable, very uniform, and more abrasion
resistant than electrochemical coloring.
[0034] In another embodiment of the present invention, the PTFE
coating provides a color coding in lieu of or in addition to the
color coding of the wire core. Traditionally guide wires have had
PTFE coatings that are green, black, or grey. There is no apparent
reason for the limitation on the colors for the PTFE coatings, but
the limited colors for the coatings prevent any brand recognition
and result in most guide wires having the same appearance. Applying
a non-standard color coating of the fluoropolymer layer, such as
blue, white, yellow, or gold, distinguishes these wires from others
existing in the market. Color coding the PTFE layer allows for
brand recognition of a manufacturer and can be used to visually
distinguish a particular type of guide wire or distinguish between
two similar guide wires used in the same procedure. The nonstandard
color PTFE coating replaces the full length standard PTFE coating
on the guide wire, making all portions of the guide wire easily
distinguishable based on the color coding.
[0035] Alternatively, the PTFE (or fluoropolymer coating) may be
applied from a solution that is spray, dip, or reel-to-reel coded.
Here, spray coating may be the most practical method since
designated sections can be more easily masked and coded with
different colored sections. In FIG. 6, a colored spray coating is
applied to a wire 10b as it passes between two nozzles 200 to color
the guide wire with a nonstandard color such as blue, white,
yellow, or gold. Masks 210 can be used to form non-colored portions
on the guide wire, which when removed presents portions of original
colored guide wire that can then be used as markers or for other
distinguishing purposes. The colored coating can be applied to the
full length of the guide wire, or to the proximal section of the
guide wire between a docking extension and a proximal end. In the
latter example, the color coating is visible to the practitioner
during the use of the guide wire, whereas the portion of the guide
wire that is not visible during use is of a traditional color.
[0036] In another embodiment of the present invention, the color
coding system is applied to the guide wire in the form of a colored
band 300 (FIG. 7) proximally positioned about the guide wire
between the docking extension and the proximal end. The colored
band 300 can be any desired length, with a preferred length of
between 1 and 20 centimeters. In this embodiment, a colored polymer
with a high adhesion to stainless steel is extruded onto the
selected section of guide wire 10. Examples of polymers that can be
used to make the color coded band include melt-processable
fluoropolymers and polyurethanes. The band 300 is selected from
colors that are different from the color of the PTFE coating 20,
and preferably stands out in contrast with the existing coating
color. Examples of band colors include white, blue, yellow, gold,
and teal. The band 300 can be applied by first removing a portion
of the existing PTFE coating 20 by laser or other means, and then
polishing and/or grinding the bare stainless steel core 22 to
create a roughened surface for better polymer adhesion. A silane
coating may be applied to further promote polymer adhesion.
[0037] The process of applying the band 300 preferably includes
grinding the desired section of wire core 22 slightly to ensure
that the final diameter of the extruded band 300 is no greater than
the diameter of the PTFE coating. Decreasing the core wire diameter
will also increase the thickness of the extruded band 300, which
may make the band 300 more opaque for a given colorant loading. The
grinding process may also have gradual or abrupt tapers or a
selected grind profile to aid in the adhesion of the band to the
wire core. In an alternative process, the guide wire is jerked
rapidly from the extruder once the desired length of polymer is
extruded onto the guide wire, as this jerking prevents more polymer
from coating onto the wire. The extrusion die assembly may also be
modified so that the molten extrusion polymer flows into a cavity
between the die and the wire core. Once cooled, the guide wire is
jerked out of the extrusion assembly to limit the amount of polymer
accumulating on the guide wire. Once the guide wire is removed from
the extrusion assembly, excess extruded polymer is removed to make
the band length uniform and to expose the docking extension portion
of the guide wire. The band 300 may be heated and/or glued to the
wire 22 for better adhesion and to prevent ends of the band from
protruding above the surface of the PTFE coating, and a lubricious
coating may also be applied to the band to minimize catheter
interference or frictional sticking points.
[0038] For example, standard blue Pellethane 90AE was extruded onto
the proximal end of a guide wire to create a marker. The marker
adhered well to the guide wire, and the blue polymer was very
opaque, although a yellow or gold marker may be even more
visible.
[0039] In yet another embodiment of the present invention, the
color coding of guide wires is accomplished using ultra-short,
ultra-intense laser beams (e.g., femtosecond laser) directed to the
wire core, altering the surface characteristics of the wire core.
The laser forms nanostructures on the surface of the guide wire
that affect the way light is absorbed and reflected off the
surface. This alteration in the reflection of the light is
perceived by humans as a variation in the color of the guide wire
core.
[0040] In FIG. 8, a laser 400 such as a femtosecond laser is
directed toward a guide wire core 22 surface to form nanostructures
on the guide wire core surface. The guide wire may be rotated and
transversed relative to the laser in order to form a band 410 of
modified surface over the length of the guide wire core. The
modified band will have a color that is pre-selected to stand out
from the original appearance of the guide wire core to distinguish
and differentiate the guide wire from other guide wires having the
original appearance. It will be appreciated that various shapes may
be produced on the guide wire surface with the desired colors using
this process. Also, multiple colors may be achieved using the same
laser source without the need for changing the set-up of the
apparatus. The laser forms nanostructures on the surface of the
wire core such as pits, globules, and strands that modify the
optical characteristics of the material. Variation in the laser
intensity, pulse length, and number of pulses varies the size and
shape of the nanostructures, and thus the appearance of the
material. A metallic material such as aluminum can be made to
appear gold, for example. Refining the process yields more color
options, including almost all desired colors and multicolor
appearance such as iridescence.
[0041] The advantages of this process include the length of the
coloring of the guide wire can be all or partial, depending upon
the needs of the user. The process does not involve toxic chemicals
and the colors do not dull over time. There are no additional
materials that are added to the guide wire. The process eliminates
the need for a separate manufacturing and subsequent bonding of
colored components, and because the process only affects a small
surface layer of the guide wire it does not significantly alter any
material properties of the guide wire.
[0042] Since more than one guide wire is deployed simultaneously in
about 40% of the worldwide percutaneous coronary interventions
(PCI), there can be some confusion in identifying between the two
guide wires during use. In one embodiment, as shown in FIGS. 9-14,
a tubular sleeve 500 has a color coating 502 (or is inherently
infused with a color) in order to help identify and distinguish
between two guide wires deployed simultaneously. The tubular sleeve
500 has a lumen 504 that extends therethrough and an outer diameter
506 that is sized to approximately match the outer diameter of a
guide wire. As shown in FIG. 10, tubular sleeve 500 is sized to
slide onto the proximal end 514 of the guide wire assembly. The
guide wire assembly includes a distal end 512 having an atraumatic
tip which is know in the art. In one embodiment, as shown in FIGS.
10-12, the guide wire assembly 510 has an undulating wire 516 that
is used to dock with an extension wire in well known over-the-wire
PCI's. The undulating wire 516 is formed by grinding the proximal
end 514 of the guide wire 510 in which a tapered proximal section
518 is formed to provide a smooth transition between the guide wire
and the undulating wire 516. The undulating wire 516 is sometimes
referred to as the "coined" portion of the guide wire assembly 510.
In this embodiment, tubular sleeve 500, with color coating 502,
slides over the undulating wire 516 and is pushed distally onto the
tapered proximal section 518 until the tubular sleeve firmly lodges
onto the tapered proximal section. The lumen 504 of the tubular
sleeve has a diameter that is greater than the maximum diameter of
the undulating wire 516, but is less than the maximum diameter of
the tapered proximal section, thereby allowing the tubular sleeve
to lodge onto the tapered proximal section as shown in FIG. 12.
[0043] During a PCI procedure, when two guide wire assemblies 510
are used simultaneously, the color coded tubular sleeve 500 of one
of the guide wires can be removed so that the physician can
distinguish between the two guide wires. The tubular sleeve 500 is
removed by gripping the sleeve with the fingers and thumb and
pulling in a proximal direction thereby sliding the sleeve over the
undulating wire 516 and removing it from the guide wire assembly
510. One of the guide wires will have a tubular sleeve 500, and the
other guide wire will no longer have a color coded tubular sleeve,
thereby the physician can easily distinguish between the two wires
during the PCI procedure. If light hand pressure is insufficient to
remove a tubular sleeve from the guide wire assembly, a pair of
tweezers or small pliers can be used to remove the tubular
sleeve.
[0044] The color coating 502, or the color of the tubular sleeve
500, can be essentially any color including black, crimson, green,
amber, red, yellow, orange, white, blue, gray, or any combination
of these colors. It is contemplated that the tubular sleeve 500 be
formed from a polymer material that may either already have a
specific color, or may be coded with any of the colors
identified.
[0045] The tubular sleeve 500 is formed from a polymer material
that includes fluoropolymer, polyester, Pebax, polyolefin,
thermoplastic or thermoset shrink tubing, polyimide,
polyethyetherether-keytone (PEEK), or other thermoplastics or
thermosets extruded into a tubular form. Further, tubular sleeve
500 can be formed from braided polymer strands made from aramid
fibers (e.g., Kevlar), or other pigmented thermoplastics or
thermosets. Tubular sleeve 500 also can be formed of a metallic
hypotube or foil with or without a color band applied or have a
color coating applied by pad printing or ink jet printing. A
metallic hypotube also can be colorized by anodizing or using
thermal oxidation to produce a color such as straw, amber, blue,
dark grey, or black scale coloring. Further, tubular sleeve 500 can
be formed from coiled or braided metallic wire or wire ribbon with
or without anodizing or oxidizing the metal.
[0046] The guide wire assemblies associated with this aspect of the
invention generally will have an outer diameter of 0.25 mm (0.010
inch) to 0.45 mm (0.018 inch). The lumen 504 of the tubular sleeve
500 will have a diameter that is smaller than the maximum diameter
of the proximal tapered section of the guide wire assembly. The
length of the tubular sleeve 500 can range from 2.0 mm (0.08 inch)
up to 50.0 mm (2.0 inches). For example, using a guide wire having
an outer diameter of 0.35 mm (0.014 inch), a 2.0 mm (0.08 inch)
length of tubular sleeve 500 slides over the undulating wire 516
(coined section) and is pushed onto the tapered proximal section
518 of the guide wire until it is firmly lodged onto the tapered
proximal section. Alternatively, a length of tubular sleeve 500
slides over the undulating wire 516 and is lodged onto the tapered
proximal section 518. Thereafter, any portion of the tubular sleeve
extending proximally beyond the undulating wire 516 is trimmed off
leaving approximately 0.5 mm (0.02 inch) extending beyond the
undulating wire 516 in a proximal direction. The diameter of lumen
504 of the tubular sleeve 500 can range from 0.25 mm (0.01 inch) to
0.26 mm (0.01 inch). Tubular sleeves 500 of the type disclosed
herein are commercially available from various manufacturers such
as Zeus, Inc. and MicroLumen.
[0047] In another embodiment, as shown in FIG. 13, the guide wire
assembly 510 has a distal end 512 and a proximal end 514. In this
embodiment, a tapered section 530 is ground onto the proximal end
of the guide wire assembly in order to receive a tubular sleeve 500
as previously described. In this embodiment, the tubular sleeve has
a color coating 502 and a lumen 504 sized to receive and slide over
the tapered section. As previously described, the tubular sleeve
500 is pushed onto the tapered section where it will lodge and
firmly attach. The tubular sleeve 500 can be removed using finger
pressure or by tweezers or small pliers as previously described. In
this embodiment, the length of tubular sleeve 500 can range from
2.0 mm (0.08 inch) to 50.0 mm (2.0 inches), and a portion of the
tubular sleeve may extend beyond the proximal end 514 by
approximately 0.5 mm (0.02 inch).
[0048] In another embodiment, as shown in FIG. 14, a guidewire
assembly 510 has a distal end 512 and a proximal end 514. A tubular
sleeve 500 has a color coating 502 and a lumen 504 sized to allow
the tubular sleeve to slide over the guide wire assembly 510. The
tubular sleeve 500 will have a tight or snug fit on the guide wire
assembly so that it is not easily removed, but can be removed when
two guide wires are used simultaneously and one of the tubular
sleeves is removed so that the physician can distinguish between
the two guide wires. In this embodiment, the tubular sleeve can
have a length ranging from 2.0 mm (0.08 inch) to 50.0 mm (2.0
inches), and approximately 0.5 mm (0.02 inch) of the tubular sleeve
can extend beyond the proximal end 514 of the guide wire assembly
510. In this embodiment, the color coded tubular sleeve can be
positioned anywhere along the proximal 50 cm (19.7 inches) of the
guide wire.
[0049] It is to be understood that the foregoing description is
intended to be illustrative of embodiments of the present invention
but is not intended to be limiting in any manner. One of ordinary
skill in the art will readily appreciate modifications and
alterations to the above described examples, and the intention
includes all such modifications and alterations. Accordingly, the
scope of the invention is properly interpreted to be encompassed by
the words of the appended claims, using the words' ordinary
meaning, without limiting the definition of those words to the
examples provided herein.
* * * * *