U.S. patent number RE33,911 [Application Number 06/847,297] was granted by the patent office on 1992-05-05 for catheter guide wire with short spring tip and method of using the same.
This patent grant is currently assigned to Advanced Cardiovascular Systems, Inc.. Invention is credited to Wilfred J. Samson, Ronald J. Solar.
United States Patent |
RE33,911 |
Samson , et al. |
May 5, 1992 |
Catheter guide wire with short spring tip and method of using the
same
Abstract
Guide wire and method for insertion and use of a catheter. The
guide wire has a shaft of substantially smaller diameter than the
luminal opening, with a flexible coil at one end of the shaft. The
guide wire is inserted into the cardiovascular system, and the
catheter is advanced along the guide wire to the desired position,
with the flexible coil outside the distal end of the catheter. An
annular passageway is formed between the shaft and the wall of the
luminal opening, and fluids are passed through this passageway
while the guide wire is within the catheter. A marker of radio
opaque material is provided at the distal end of the guide wire so
that the position of the wire can be accurately determined even
though the wire itself may be too small to be visible with a
fluoroscope.
Inventors: |
Samson; Wilfred J. (Saratoga,
CA), Solar; Ronald J. (San Diego, CA) |
Assignee: |
Advanced Cardiovascular Systems,
Inc. (Santa Clara, CA)
|
Family
ID: |
27057787 |
Appl.
No.: |
06/847,297 |
Filed: |
March 27, 1986 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
Reissue of: |
513222 |
Jul 13, 1983 |
04554929 |
Nov 26, 1985 |
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Current U.S.
Class: |
600/585; 600/434;
604/95.01 |
Current CPC
Class: |
A61M
25/09 (20130101); A61M 25/0108 (20130101); A61B
90/39 (20160201); A61M 2025/09175 (20130101) |
Current International
Class: |
A61B
19/00 (20060101); A61M 25/01 (20060101); A61B
005/02 () |
Field of
Search: |
;128/772,656-658
;604/95,164,170,280-283 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Pellegrino; Stephen C.
Attorney, Agent or Firm: Fulwider, Patton, Lee &
Utecht
Claims
We claim: .[.1. In a guide wire for use in the placement of a
catheter in the cardiovascular system, an elongated shaft of
relatively rigid material having proximal and distal ends and a
cross-sectional area substantially smaller than the luminal opening
in the catheter, a relatively flexible helical coil having proximal
and distal ends, said coil having an outer diameter slightly
smaller than the diameter of the luminal opening and a length
substantially less than the length of the shaft, the distal end
portion of the shaft extending into the coil but terminating short
of the distal end of the coil, the portion of the shaft extending
into the coil being tapered to provide a gradual transition in
flexibility of the shaft, means for bonding the proximal end of the
coil to the shaft and a flexible safety wire disposed interiorally
of the coil and having one end bonded to the distal extremity of
the shaft and having the other end bonded to the
distal extremity of the coil..]. 2. A guide wire as in claim
.[.1.]. .Iadd.17 .Iaddend.wherein the safety wire is formed as a
flat ribbon
having a generally rectangular cross section. 3. A guide wire as in
claim .[.1.]. .Iadd.17 .Iaddend.together with a relatively smooth
rounded tip
disposed at the distal extremity of the coil. 4. A guide wire as in
claim .[.1.]. .Iadd.17 .Iaddend.together with a radio opaque marker
formed of radio opaque material carried by the shaft adjacent the
distal end of the
shaft. 5. A guide wire as in claim 4 wherein the radio opaque
material has
a density of at least 13 gm/cm.sup.3. 6. A guide wire a in claim 5
wherein the radio opaque material includes an element selected from
the group consisting of gold, tantalumm, tungsten, platinum,
iridium, rhenium and
alloys thereof. 7. A guide wire as in claim 6 wherein the radio
opaque material comprises an alloy containing on the order of 80%
gold, 12%
siliver, and 8% copper and zinc. 8. A guide wire as in claim
.[.1.]. .Iadd.17 .Iaddend.wherein the helical coil is formed of a
radio opaque
material. 9. .[.In apparatus.]. .Iadd.A dilatation catheter
assembly .Iaddend.for use in the cardiovascular system.[.,.].
.Iadd.of a patient comprising .Iaddend.an elongated, relatively
flexible catheter having a wall defining an axially extending
.[.luminal opening.]. .Iadd.lumen .Iaddend.and a guide wire
extending through the .[.luminal opening.]. .Iadd.lumen
.Iaddend.and having a .[.cross-sectional area.]. .Iadd.diameter
.Iaddend.substantially smaller than the .[.luminal opening.].
.Iadd.lumen .Iaddend.so that fluids can pass freely between the
guide wire and the wall defining the .[.luminal opening.].
.Iadd.lumen.Iaddend., said guide wire comprising an elongated shaft
of relatively rigid material having proximal and distal ends and a
.[.cross-sectional area.]. .Iadd.diameter .Iaddend.substantially
smaller than .[.the luminal opening in the catheter.]. .Iadd.0.02
inch.Iaddend., a relatively flexible helical coil having proximal
and distal ends, said coil having an outer diameter slightly
smaller than .[.the diameter of the luminal opening.]. .Iadd.0.02
inch and substantially larger than the diameter of the shaft
.Iaddend.and a length substantially less than the length of the
shaft, the distal end portion of the shaft extending into the
helical coil but terminating short of the distal end of the coil,
the portion of the shaft extending into the coil being tapered to
provide a gradual transition in flexibility of the shaft, means for
bonding the proximal end of the coil to the shaft and a flexible
safety wire disposed interiorally of the coil and having one end
bonded to the distal extremity of the shaft and having the other
end bonded to the distal extremity of
the coil. 10. Apparatus as in claim 9 wherein the safety wire is
formed as
a flat ribbon having a generally rectangular cross section. 11.
Apparatus as in claim 9 wherein the luminal opening has a diameter
on the order of 0.020 inch, the guide wire shaft has a diameter on
the order of 0.008
inch, and the helical coil has a diameter on the order of 0.018
inch. 12. Apparatus as in claim 9 together with a radio opaque
marker formed of radio opaque material carried by the shaft
adjacent the distal end of the
shaft. 13. Apparatus as in claim 12 wherein the radio opaque
material has
a density of at least 13 gm/cm.sup.3. 14. Apparatus as in claim 12
wherein the radio opaque material includes an element selected from
the group consisting of gold, tantalum, tungsten, platinum,
iridium, rhenium and
alloys thereof. 15. Apparatus as in claim 12 wherein the radio
opaque material comprises an alloy containing on the order of 80%
gold, 12%
silver, and 8% copper and zinc. 16. The apparatus of claim 12
wherein the
helical coil is formed of a radio opaque material. .Iadd.17. A
guide wire for use in the placement of a catheter having an inner
lumen extending therein into a patient's cardiovascular system
comprising:
a) an elongated shaft of relatively rigid material having proximal
and distal ends and a diameter substantially smaller than the
diameter of the inner lumen;
b) a relatively flexible helical coil having proximal and distal
ends and an outer diameter slightly smaller than 0.02 inch and
substantially larger than the diameter of the shaft and a length
substantially less than the length of the shaft, the distal end
portion of the shaft being tapered to provide a gradual transition
in flexibility of the shaft and the tapered portion and extending
into the coil but terminating short of the distal end of the
coil;
c) means for bonding the proximal end of the coil to the shaft;
and
d) a flexible safety wire disposed interiorly of the coil and
having one end bonded to the distal extremity of the shaft and
having the other end bonded to the distal extremity of the coil.
.Iaddend.
Description
This invention pertains generally to the insertion of catheters
into the cardiovascular system, and more particularly to a guide
wire and method for inserting and using a catheter.
Guide wires heretofore utilized in the insertion of catheters into
the cardiovascular system have included an elongated wire core
surrounded by a helically wrapped outer wire of smaller diameter
than the luminal openings of the catheters with which they are
employed. With dilation catheters for use in the coronary vessels
and catheters of relatively small diameter (e.g., 0.020 inch or
less), the guide wire is only slightly smaller than the luminal
opening, and the guide wire must be removed before any fluid is
passed through the catheter. It has generally not been possible to
make the guide wire smaller because it might not have sufficient
torsional rigidity to permit it to be steered into the
cardiovascular system. In addition, the smaller wire might puncture
the wall of the artery or other surrounding tissue.
Another problem which catheters of relatively small diameter is
determining the position of the guide wire. Larger guide wires are
generally visible with a fluoroscope or other radiographic
instrument, but with the smaller catheters, the guide wires may be
too small to be seen in this manner.
It is in general an object of the invention to provide a new and
improved guide wire and method for the insertion and use of
catheters into the cardiovascular system.
Another object of the invention is to provide a guide wire and
method of the above character in which the guide wire remains in
the catheter while the catheter is in use.
These and other objects are achieved in accordance with the
invention by providing a guide wire having an elongated shaft of
relatively rigid material and a helical coil at the distal end of
the shaft. The guide wire is inserted into the cardiovascular
system, and the catheter is advanced along the guide wire to the
desired position, with the helical coil outside the distal end of
the catheter. The shaft of the guide wire is substantially smaller
than the luminal opening of the catheter, and fluids are passed
through the luminal opening while the guide wire is still in place.
A marker of radio opaque material is provided at the distal end of
the guide wire so that the position of the wire can be accurately
determined even though the wire itself may be too small to be
visible with a fluoroscope.
FIG. 1 is a side elevational view of a catheter and a guide wire
incorporating the invention.
FIG. 2 is an enlarged fragmentary centerline sectional view of the
distal end portion of the guide wire in the embodiment of FIG.
1.
FIG. 3 is a fragmentary elevational view of the tip portion of the
guide wire of FIG. 1, illustrating the manner in which the tip can
be shaped to facilitate insertion into a given artery.
FIG. 4 is an enlarged, fragmentary centerline sectional view of
another embodiment of a guide wire incorporating the invention.
In FIG. 1, the guide wire 11 is illustrated in connection with a
catheter 12 having a proximal end 13 and a distal end 14. The
catheter comprises an elongated tubular body of relatively flexible
material having an axially etending luminal opening or passageway
16, with a connector fitting 17 at the proximal end of the tubular
body. The catheter can be of any desired type, for example, a
dilation catheter having a inflatable balloon toward the distal end
thereof.
Guide wire 11 comprises an elongated, relatively rigid shaft 21
having a proximal end 22 and a distal end 23, with a relatively
flexible helical coil or spring 24 extending axially from the
distal end of the shaft. The cross-sectional area of the shaft is
substantially smaller than the luminal opening of the catheter so
that fluids can pass freely between the shaft and the wall of the
luminal opening, and the outer diameter of the helical winding is
greater than the diameter of the shaft but small enough to pass
through the luminal opening. In one presently preferred embodiment
for use with a catheter having a luminal opening of 0.020 inch, for
example, the shaft has a diameter on the order of 0.008 inch and
the helical coil has an outer diameter on the order of 0.018 inch.
The coil is relatively short compared to the overall length of the
guide wire, and shaft 21 is substantially longer than the coil. In
one presently preferred embodiment, for example, the guide wire has
an overall length on the order of 175 cm, and the helical coil has
a length on the order of 4 cm.
Shaft 21 and helical coil 24 are each fabricated of a suitable
material such as stainless steel wire, and in the embodiment of
FIG. 1 the distal end portion of the shaft is tapered to provide a
gradual transition in flexibility between the very flexible coil
and the stiffer shaft. In this particular embodiment, the tapered
portion of the shaft extends all the way to the distal end of the
coil, but it can terminate before the end, if desired.
The coil and shaft are bonded together by suitable means such as
brazing, welding or soldering, as indicated at 29, in the region of
the overlap. If desired, the bond can be made with a radio opaque
material to make the tip of the wire visible to a fluoroscope or
other conventional radiographic instrument. The radio opaque
material preferably has a density of at least 13 gm/cm.sup.3, and
suitable materials include gold, tantalum, tungsten, platinum,
iridium, rhenium and alloys of these materials. One presently
preferred material is an alloy containing on the order of about 80%
gold, 12% silver, and 8% copper and zinc. If desired, coil 24
itself can be fabricated of a radio opaque material such as
tungsten, tantalum, platinum, gold or an alloy thereof to make the
entire coil visible to a fluoroscope.
A relatively smooth, rounded tip 31 is provided at the distal end
of helical coil to facilitate insertion of the wire into the
cardiovascular system without damage to the surrounding tissue. If
the embodiment illustrated, this tip comprises a plug which is
inserted partially into the distal end portion of coil 24 and
heated to form a bond with the coil and the tip of shaft 21. This
plug can also be fabricated of a radio opaque material to make the
tip visible to a fluoroscope or other radiographic instrument.
Alternatively, the rounded tip can be formed by fusing the distal
end of the wire forming the helical coil into the desired rounded
shape.
In the embodiment of FIG. 1, connections to the proximal ends of
guide wire 11 and catheter 12 are made through a side arm adapter
36 having an axially extending body 37 and a side arm 38 which
extends at an angle from the body. The connector fitting 17 at the
proximal end of the catheter is connected to one end of the adapter
body by suitable connector 39, and the luminal opening of the
catheter is in fluid communication with the chamber formed within
the adapter. The guide wire extends axially through the adapter
body, and a control knob 41 is affixed to the end of the wire
beyond the adapter. An O-ring assembly 42 provides a fluid-tight
seal about the guide wire at the rear of the adapter body while
permitting the wire to be rotated within the body. Communication
with the passageway of the catheter is provided through side arm
38, and suitable appliances can be connected to the side arm for
introducing fluids into or receiving fluids from the catheter.
Operation and use of the guide wire, and therein the method of the
invention, are as follows. The guide wire is inserted into the
luminal opening of the catheter, and the guide wire and the
catheter are inserted together into the cardiovascular system, with
helical coil 24 extending from the distal end of the catheter. The
guide wire and catheter can be inserted either directly into the
system or through a guiding catheter, as desired. The torsional
rigidity of shaft 21 permits the guide wire to be turned or steered
by rotating control knob 41, and the flexibility of coil 24
facilitates movement of the wire into the artery or other
passageway in the body without damage to the surrounding tissue.
The position of the wire is determined by monitoring the radio
opaque marker or markers at the distal end with a fluoroscope or
other radiographic instrument. The catheter is advanced along the
wire until it is in the desired position. Because of the relatively
small diameter of shaft 21 compared to the cross-sectional area of
the luminal opening, fluids can be passed through the catheter
without removing the guide wire. For example, a contrast material
or dye can be introduced through the annular passageway formed
between the shaft of the guide wire and the wall of the luminal
opening, and pressure measurements can be made through this same
passageway.
As illustrated in FIG. 3, coil 24 can be bent in any suitable
manner to facilitate steering of the wire into a side branch of the
cardiovascular system. The angle of the bend can be chosen in
accordance with the angle of the branch into which the guide wire
is to be inserted.
The embodiment of FIG. 4 is generally similar to the embodiment of
FIGS. 1-2, and like reference numerals designate corresponding
elements in the two embodiments. In the embodiment of FIG. 4, the
tapered end portion 23 of the shaft 21 terminates prior to the
distal end of coil 24, and the windings toward the distal end of
the coil are spaced apart to provide a tip which is substantially
more flexible than the remainder of the guide wire. A safety wire
36 extends between the distal end of shaft 21 and the distal end of
coil 24, and is fabricated of a material stronger than the coil.
This wire prevents the coil from being overstretched or broken in
use, and it also facilitates the shaping of coil 24 into various
curves for steering into side branches of the cardiovascular
system. Suitable materials for the safety wire include tungsten and
other metals or alloys stronger than stainless steel. In one
presently preferred embodiment, the wire comprises a flat tungsten
ribbon having a generally rectanguar cross-section, with a width of
about 0.003 inch and a thickness of about 0.001 inch. This ribbon
allows the coil to remain extremely flexible and helps the coil
retain a curvature to which it is formed. The safety wire is bonded
both to shaft 21 and to end plug 31, and in the embodiment
illustrated, the proximal end of the safety wire is secured by the
same bond 29 that affixes the coil to the shaft. Alternatively, if
desired, the proximal end of the safety wire can be affixed to the
tapered portion of the shaft. Operation and use of the embodiment
of FIG. 4 is similar to that described above.
It is apparent from the foregoing that a new and improved guide
wire and method of using the same have been provided. While only
certain presently preferred embodiments have been described in
detail, as will be apparent to those familiar with the art, certain
changes and modifications can be made without departing from the
scope of the invention as defined by the following claims.
* * * * *