IES84321Y1 - A guide wire for use in re-canalising a vascular occlusion in a human or animal subject - Google Patents
A guide wire for use in re-canalising a vascular occlusion in a human or animal subject Download PDFInfo
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- IES84321Y1 IES84321Y1 IE2005/0164A IE20050164A IES84321Y1 IE S84321 Y1 IES84321 Y1 IE S84321Y1 IE 2005/0164 A IE2005/0164 A IE 2005/0164A IE 20050164 A IE20050164 A IE 20050164A IE S84321 Y1 IES84321 Y1 IE S84321Y1
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- Prior art keywords
- terminal member
- guide wire
- leading edge
- core wire
- distal
- Prior art date
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- 206010053648 Vascular occlusion Diseases 0.000 title claims abstract description 24
- 230000002792 vascular Effects 0.000 claims abstract description 52
- 239000000696 magnetic material Substances 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 7
- 238000005452 bending Methods 0.000 abstract description 7
- 239000000463 material Substances 0.000 description 22
- 229910000679 solder Inorganic materials 0.000 description 12
- 238000005219 brazing Methods 0.000 description 8
- 238000005476 soldering Methods 0.000 description 8
- 230000000149 penetrating Effects 0.000 description 6
- 230000001154 acute Effects 0.000 description 5
- 230000001070 adhesive Effects 0.000 description 5
- 239000000853 adhesive Substances 0.000 description 5
- 238000003466 welding Methods 0.000 description 5
- 230000000875 corresponding Effects 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 229940079593 drugs Drugs 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 230000035515 penetration Effects 0.000 description 4
- 230000003014 reinforcing Effects 0.000 description 4
- 239000010935 stainless steel Substances 0.000 description 4
- 229910001220 stainless steel Inorganic materials 0.000 description 4
- 210000000748 cardiovascular system Anatomy 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- 230000001225 therapeutic Effects 0.000 description 3
- 210000001367 Arteries Anatomy 0.000 description 2
- 229910001260 Pt alloy Inorganic materials 0.000 description 2
- 102100000672 SMPX Human genes 0.000 description 2
- 108060007673 SMPX Proteins 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 238000002399 angioplasty Methods 0.000 description 2
- UIMGJWSPQNXYNK-UHFFFAOYSA-N azane;titanium Chemical class N.[Ti] UIMGJWSPQNXYNK-UHFFFAOYSA-N 0.000 description 2
- 230000002708 enhancing Effects 0.000 description 2
- -1 for example Inorganic materials 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229910001000 nickel titanium Inorganic materials 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 241001325354 Lamiinae Species 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- CWYNVVGOOAEACU-UHFFFAOYSA-N fe2+ Chemical compound [Fe+2] CWYNVVGOOAEACU-UHFFFAOYSA-N 0.000 description 1
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- 239000000843 powder Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
Abstract
ABSTRACT A guide wire (1) for re-canalising a vascular occlusion comprises a core wire (5) which terminates at its distal end (4) in a terminal member (7) for opening the occlusion. A helical coil sleeve (10) extends around the core wire (5) from the terminal member (7) to a location (11) along the core wire (5). The terminal member (7) defines first and second planar surface portions (13, 14) which converge towards a distal transversely extending leading edge portion (8). As the terminal member (7) is urged through the vascular occlusion, the first and second surface portions (13, 14) act on the occlusion to form an opening therethrough. A distal portion (28) of the core wire (5) is of spade-like configuration for facilitating bending thereof for directing the terminal member (7) out of a central major plane (35) defined by the distal portion (28) for facilitating aligning of the terminal member (7) with a branched Vessel of the vascular system.
Description
“A guide wire for use in re-canalising a vascular occlusion
in a human or animal subject"
The present invention relates to a guide wire for use in a re-canalising process of a
vascular occlusion in a human or animal subject, and in particular, for re-canalising a
blocked or partially blocked artery, for example, in the cardiovascular system,
although the invention is not limited to a guide wire for such use. The invention also
relates to a method for re-canalising a vascular occlusion in a human or animal
subject.
Guide wires are commonly used for guiding a catheter carrying a therapeutic or
other device to a remote location in the vascular system of a subject. For example,
where a vessel is occluded or partially occluded. a guide wire is used for guiding a
catheter which may carry a balloon or a stent at its distal tip for locating in the artery
in the occluded part thereof for maintaining a passage through the occlusion.
However, prior to the insertion of the stent or other such device, the occlusion must
be penetrated in order to open a passage therethrough for accommodating the stent.
Guide wires are provided for penetrating such occlusions or partial occlusions prior
to the insertion of the catheter over the guide wire. U.S. Patent Specification No.
6,348,040 of Stalker, et al discloses such a catheter which is provided with a
vibrating tip. However, a disadvantage of the guide wire disclosed in this U.S.
Patent specification is that in order to provide the vibrating tip, relatively expensive
and, more importantly, cumbersome equipment is required, which must be attached
to the guide wire.
U.S. Patent Specification No. 6,669,652 of Anderson, et al discloses a guide wire,
which comprises a core wire and a helical coil extending around a distal portion of
the core wire. The helical coil extends beyond the distal end of the core wire, and
tapers to a distal point for penetrating the occlusion as the guide wire is urged
forwardly. One disadvantage of the guide wire disclosed in this U.S. specification is
that due to the fact that the tip is pointed, there is a danger of the tip penetrating the
wall of a vessel of the vascular system as the guide wire is being urged to the
occlusion. Another disadvantage of this guide wire is that the portion of the helical
coil which extends beyond the distal end of the core wire is relatively flaccid, and
thus renders the guide wire difficult to guide through the vascular system, and in
particular a vascular system with branched vessels.
U.S. Patent Specifications Nos. 5,527,298 and 5,127,917 disclose guide wires in
which the distal end of the guide wires terminate in bulbous distal tip portions. The
distal tip portions are of transverse cross-sectional area significantly greater than the
transverse cross-sectional area of the guide wire, and taper to a distal point. The
distal point facilitates penetration of the occlusion, and the tapering portion facilitates
in easing the guide wire through the occlusion. However, a disadvantage of the
guide wires disclosed in these two U.S. Patent specifications is that due to the fact
that the transverse cross-sectional area of the bulbous distal tip portions are
significantly greater than the transverse cross-sectional area of the guide wire,
difficulty is experienced in subsequently urging a catheter over the bulbous tip
portions.
There is therefore a need for a guide wire which is suitable for use in a re-canalising
process of a vascular occlusion in a human or animal subject.
The present invention is directed towards providing such a guide wire, and the
invention is also directed towards providing a method for re-canalising a vascular
occlusion in a human or animal subject.
According to the invention there is provided a guide wire for use in a re-canalising
process for re-canalising a vascular occlusion in a human or animal subject, the
guide wire extending between a proximal end and a distal end, and defining a
longitudinally extending main central axis, wherein the guide wire terminates at its
distal end in a terminal member extending axially from the guide wire, the terminal
member tapering to a distal leading tip portion for engaging and gradually opening
the occlusion as the terminal member is urged therethrough.
Preferably, the leading edge portion is an elongated leading edge portion.
Advantageously, the leading edge portion extends in a direction at an angle relative
to an axial direction defined by the main central axis.
In one embodiment of the invention the leading edge portion extends in a direction at
an angle in the range of 1° to 90° relative to an axial direction defined by the main
central axis. Preferably, the leading edge portion extends in a direction at an angle
in the range of 45° to 90° relative to an axial direction defined by the main central
axis. Advantageously, the leading edge portion extends in a direction at an angle of
approximately 60° relative to an axial direction defined by the main central axis.
In one embodiment of the invention the leading edge portion extends in a direction
substantially transversely of the main central axis.
In one embodiment of the invention a first surface portion of the terminal member
converges towards an opposite second surface portion thereof towards the leading
edge portion.
In another embodiment of the invention the first surface portion of the terminal
member is planar.
In a further embodiment of the invention the first surface portion of the terminal
member is convex in a longitudinal direction relative to the main central axis.
In a still further embodiment of the invention the first surface portion of the terminal
member is concave in a longitudinal direction relative to the main central axis.
In a still further embodiment of the invention the first surface portion of the terminal
member is sequentially convex and concave in a longitudinal direction relative to the
main central axis.
In one embodiment of the invention a distal portion of the first surface portion of the
terminal member is concave in a longitudinal direction relative to the main central
axis.
In another embodiment of the invention a proximal portion of the first surface portion
of the terminal member is convex in a longitudinal direction relative to the main
central axis.
In another embodiment of the invention the first surface portion of the terminal
member is convex in a transverse direction relative to the main central axis.
In a further embodiment of the invention the second surface portion of the terminal
member converges towards the first surface portion towards the leading edge
portion.
In one embodiment of the invention the second surface portion of the terminal
member is planar.
In another embodiment of the invention the second surface portion of the terminal
member is convex in a longitudinal direction relative to the main central axis.
In a further embodiment of the invention the second surface portion of the terminal
member is concave in a longitudinal direction relative to the main central axis.
In a still further embodiment of the invention the second surface portion of the
terminal member is sequentially convex and concave in a longitudinal direction
relative to the main central axis.
in a still further embodiment of the invention a distal portion of the second surface
portion of the terminal member is concave.
In a further embodiment of the invention a proximal portion of the second surface
portion of the terminal member is convex.
In one embodiment of the invention the second surface portion of the terminal
member is convex in a transverse direction relative to the main central axis.
Preferably, the first and second surface portions terminate in the leading edge
portion to define the leading edge portion as a chisel edge.
In one embodiment of the invention the first and second surface portions of the
terminal member define an included angle in the range of 1° to 179°. Preferably, the
first and second surface portions of the terminal member define an included angle in
the range of 5° to 90°. Advantageously, the first and second surface portions of the
terminal member define an included angle of approximately 15°.
In one embodiment of the invention the first and second surface portions of the
terminal member are joined by spaced apart opposite third and fourth surface
portions. Preferably, the leading edge portion of the terminal member extends
between the third and fourth surface portions.
In one embodiment of the invention the third and fourth surface portions of the
terminal member are planar surfaces. In an alternative embodiment of the invention
the third and fourth surface portions of the terminal member are convex in a
transverse direction relative to the main central axis.
In another embodiment of the invention the third and fourth surface portions of the
terminal member are parallel to each other in an axial direction defined by the main
central axis.
Alternatively, the third and fourth surface portions of the terminal member taper
towards the leading edge portion.
In one embodiment of the invention the third and fourth surface portions of the
terminal member define an included angle in the range of 1° to 179°. Preferably, the
third and fourth surface portions of the terminal member define an included angle in
the range of 5° to 90°. Advantageously, the third and fourth surface portions of the
terminal member define an included angle of approximately 15°.
In one embodiment of the invention the third surface portion of the terminal member
is convex in a longitudinal direction relative to the main central axis. Alternatively,
the third surface portion of the terminal member is concave in a longitudinal direction
relative to the main central axis.
In another embodiment of the invention the third surface portion of the terminal
member is sequentially convex and concave in a longitudinal direction relative to the
main central axis.
In a still further embodiment of the invention a distal portion of the third surface
portion of the terminal member is concave in a longitudinal direction relative to the
main central axis, and in a further embodiment of the invention a proximal portion of
the third surface portion of the terminal member is convex in a longitudinal direction
relative to the main central axis.
In one embodiment of the invention the fourth surface portion of the terminal
member is convex in a longitudinal direction relative to the main central axis.
Alternatively, the fourth surface portion of the terminal member is concave in a
longitudinal direction relative to the main central axis.
In one embodiment of the invention the fourth surface portion of the terminal
member is sequentially convex and concave in a longitudinal direction relative to the
main central axis. In a further embodiment of the invention a distal portion of the
fourth surface portion of the terminal member is concave in a longitudinal direction
relative to the main central axis, and in a still further embodiment of the invention a
proximal portion of the fourth surface portion of the terminal member is convex in a
longitudinal direction relative to the main central axis.
Preferably, the leading edge portion is radiused from the first surface portion of the
terminal member to the second surface portion thereof. Advantageously, the leading
edge portion is radiused in plan view.
In another embodiment of the invention the leading edge portion is convex in plan
view. Alternatively, the leading edge portion is concave in plan view.
In one embodiment of the invention the maximum outer transverse cross-sectional
area of the terminal member is substantially similar to the outer transverse cross-
sectional area of the guide wire adjacent the terminal member. Preferably, the outer
transverse cross-sectional area of the terminal member adjacent the guide wire is
similar to the outer transverse cross-sectional area of the guide wire adjacent the
terminal member so that the outer surface of the terminal member is in axial
alignment with the outer surface of the guide wire adjacent the terminal member.
Advantageously, the guide wire adjacent the terminal member and the terminal
member adjacent the guide wire are of circular transverse cross-section, and are of
substantially similar outer diameters.
Advantageously, the transverse width of the leading edge portion is substantially
similar to the transverse width of the guide wire adjacent the terminal member in a
plane containing the leading edge portion and extending parallel to the main central
axis.
In one embodiment of the invention the guide wire comprises an elongated core wire
extending from the proximal end to the distal end. Preferably, the terminal member
is secured to the distal end of the core wire.
Advantageously, the core wire terminates in a distal portion of rectangular transverse
cross-section defining first and second opposite major surfaces joined by first and
second opposite minor surfaces for facilitating bending thereof for offsetting the
terminal member relative to the main central axis for facilitating guiding of the
terminal member into a branched vessel of a vascular system.
In one embodiment of the invention the first and second major surfaces of the distal
portion of the core wire converge towards each other towards the distal end thereof.
Alternatively, the first and second major surfaces of the distal portion of the core wire
extend substantially parallel to each other.
In another embodiment of the invention the first and second minor surfaces of the
distal portion of the core wire diverge from each other towards the distal end thereof.
Alternatively, the first and second minor surfaces of the distal portion of the core wire
extend substantially parallel to each other.
In one embodiment of the invention a reinforcing means is provided on the distal
portion of the core wire for minimising axial twisting thereof.
in another embodiment of the invention the first and second major surfaces of the
distal portion of the core wire define therebetween a central major plane extending
parallel to the main central axis and cutting the first and second minor surfaces, and
the distal portion is curved in the central major plane for offsetting the terminal
member relative to the main central axis for in turn facilitating guiding of the terminal
member into a branched vessel of a vascular system.
Preferably, the central major plane defined by the first and second major surfaces of
the distal portion of the core wire extends transversely of a plane containing the
leading edge portion of the terminal member and extending parallel to the main
central axis.
Advantageously, the central major plane defined by the first and second major
surfaces of the distal portion of the core wire extends substantially parallel to a plane
containing the leading edge portion of the terminal member and extending parallel to
the main central axis.
In one embodiment of the invention the core wire extending from the distal portion
thereof to the proximal end is of circular transverse cross-section.
In another embodiment of the invention a sleeve extends along the core wire from
the terminal member and terminates at a location intermediate the distal end and the
proximal end of the core wire. Preferably, the sleeve is of external circular
transverse cross-section. Advantageously. the external diameter of the sleeve is
substantially similar to the diameter of the terminal member adjacent the guide wire.
Ideally, the sleeve comprises a helical coil located around the core wire adjacent the
distal end thereof.
In one embodiment of the invention a plug extends from the terminal member
adjacent a proximal end thereof for engaging an internal bore defined by the sleeve
for securing the sleeve to the terminal member.
Preferably, the terminal member is secured to the sleeve by brazing or soldering.
Advantageously, a core wire engaging bore extends into the terminal member for
engaging the distal end of the core wire.
Preferably, the core wire engaging bore extends axially into the terminal member.
Advantageously, the terminal member is secured to the core wire by brazing,
soldering, welding or adhesive. Ideally, the soldering or brazing, soldering, welding
or adhesive material is a radiopaque material.
In one embodiment of the invention the terminal member is of radiopaque material.
In another embodiment of the invention at least a portion of the terminal member is
of a magnetic material for facilitating urging of the terminal member through a
vascular system by a magnetic urging means located externally of the subject.
In a further embodiment of the invention the terminal member is of a magnetic
material.
In one embodiment of the invention a distal portion of the guide wire is of a magnetic
material for facilitating urging of the terminal member through a vascular system by a
magnetic urging means located externally of the subject.
The invention also provides in combination the guide wire according to the invention
and a magnetic urging means for urging the terminal member through a vascular
occlusion.
Preferably, the magnetic urging means for urging the terminal member through a
vascular system to a vascular occlusion.
The invention also provides a method for re-canalising a vascular occlusion in a
human or animal subject, the method comprising urging the terminal member of the
guide wire according to the invention through the occlusion for gradually opening
thereof.
Preferably, the terminal member is urged by the guide wire through a vascular
system to the occlusion prior to being urged through the occlusion.
Advantageously, the terminal member is urged through the occlusion by a magnetic
urging means located externally of the subject.
Ideally, the terminal member is urged through a vascular system by a magnetic
urging means located externally of the subject.
The advantages of the invention are many. The guide wire according to the
invention is particularly suitable for use in re-canalising a vascular occlusion in a
vascular system in a human or animal body, and in particular, for use re-canalising
an occluded or partially occluded vessel in the cardiovascular system of the human
'
11
or animal body. By virtue of the fact that the terminal member tapers to a distal
leading edge portion, the distal leading edge portion initially engages the vascular
occlusion, and as the terminal member is urged through the vascular occlusion, the
tapering portion of the terminal member gradually opens the occlusion, until the
terminal member opens the occlusion to define a bore of transverse cross-section
corresponding to the maximum external transverse cross-sectional area of the
terminal member.
By providing the terminal member to be of transverse cross-sectional area
substantially similar to that of the guide wire, so that the outer surface of the terminal
member is aligned with and substantially coincides with the outer surface of the
guide wire, a catheter can be readily easily passed over the guide wire and over the
terminal member, without snagging on the terminal member.
A particular advantage is achieved when the terminal member terminates in a
transversely extending distal leading edge portion. The transversely extending
leading edge portion facilitates ease of penetration of the vascular occlusion, and
subsequent gradual opening of the vascular occlusion as the transversely extending
leading edge portion is urged through the occlusion. By providing the terminal
member with respective opposite first and second surface portions which converge
towards each other towards the distal leading tip portion, a particularly advantageous
form of the terminal member is obtained, and the terminal member is particularly
suitable for gradually opening the vascular occlusion as the terminal member is
urged therethrough. By providing the first and second converging surface portions
as planar surface portions, a further advantage is achieved in that the rate of
penetration of the occlusion can be maintained relatively constant through the
constant increase in surface contact. Tapering the third and fourth surface portions
of the terminal member further enhances this advantage.
The provision of the terminal member with a first surface portion which is either
convex or concave, or is sequentially convex and concave from the proximal to the
distal end thereof, provides a gradual transition from the tapering portion of the
terminal member to the guide wire.
By providing the terminal member of a magnetic material, the terminal member can
be urged through the vascular system by a magnetic field generated by a suitable
magnetic urging device located externally of the subject. This has the added
advantage that the terminal member can be urged through the vascular system by
the magnetic field, rather than by pushing the guide wire into the subject. By being
able to urge the terminal member through the vascular system by an externally
generated magnetic field in particular facilitates in directing the terminal member into
a branched vessel of a vascular system, without the need to pre-bend the guide
wire. Additionally, by urging the terminal member by an externally generated
magnetic field, the risk of puncturing a vessel of the vascular system as the terminal
member is being urged therethrough is minimised.
Additionally, since it is important that the guide wire remain flexible in order to
negotiate the tortuous vascular systems of the anatomy, by magnetically pulling the
guide wire through the vascular system, the guide wire can be provided to be
considerably more flexible than would be the case where the guide wire is being
provided to be pushed through the vascular system. The more flexible a guide wire
is, the less easy it is to guide it through the vascular system by pushing. Thus, in
order to facilitate relatively accurate guiding of a guide wire through the vascular
system which is to be pushed through the vascular system, the guide wire must be
of lesser flexibility than where the guide wire is being pulled through the vascular
system. Additionally, by providing the guide wire to be magnetically pulled through
the vascular system, there is a lesser risk of the terminal member entering a false
lumen between the laminae of a vessel.
The invention will be more clearly understood from the following description of some
preferred embodiments thereof, which are given by way of example only, with
reference to the accompanying drawings, in which:
Fig. 1 is a side elevational view of a guide wire according to the invention,
Fig. 2 is a perspective view of a portion of the guide wire of Fig. 1,
Fig. 3 is another perspective view of the portion of Fig. 2 of the guide wire of
Fig. 1,
Fig. 4 is a transverse cross-sectional side elevational view of the guide wire
of Fig. 1,
Fig. 5 is a partly transverse cross-sectional side elevational view of a portion
of the guide wire of Fig. 1,
Fig. 6 is a partly transverse cross-sectional plan view of the portion of Fig. 5,
on the line VI-VI of Fig. 5 of the guide wire of Fig. 1,
Fig. 7 is a transverse cross-sectional side elevational view of a portion of the
guide wire of Fig. 1,
Fig. 8 is an end elevational view of the portion of Fig. 7 of the guide wire of
Fig. 1,
Fig. 9 is a side elevational view of another portion of the guide wire of Fig. 1,
Fig. 10 is a transverse cross-sectional side elevational view of a portion of the
guide wire of Fig. 1 with a portion of the guide wire curved,
Fig. 11 is a transverse cross-sectional side elevational view similar to Fig. 7
of a detail similar to that of Fig. 7 of a guide wire according to another
embodiment of the invention,
Fig. 12 is a transverse cross-sectional side elevational view similar to Fig. 7
of a detail similar to that of Fig. 7 of a guide wire according to another
embodiment of the invention,
Fig. 13 is a perspective view of a portion of a guide wire according to another
embodiment of the invention,
Fig. 14 is a perspective view of a portion of a guide wire according to a
further embodiment of the invention.
Fig. 15 is a perspective view of a portion of a guide wire according to a still
further embodiment of the invention,
Fig. 16 is a perspective View of a portion of a guide wire according to a
further embodiment of the invention,
Fig. 17 is an end elevationai view of the portion of the guide wire of Fig. 16,
Fig. 18 is a perspective view of a part of the portion of the guide wire of Fig.
16,
Fig. 19 is a side eievational view of a portion of a guide wire according to a
still further embodiment of the invention,
Fig. 20 is a top plan view of the portion of the guide wire of Fig. 19,
Fig. 21 is an end view of the portion of the guide wire of Fig. 19,
Fig. 22 is a top plan view of a portion of a guide wire according to another
embodiment of the invention,
Fig. 23 is an end elevational view of the portion of the guide wire of Fig. 22,
Fig. 24 is a top plan view of a portion of a guide wire according to a further
embodiment of the invention,
Fig. 25 is an end elevational view of the portion of the guide wire of Fig. 24,
Fig. 26 is a top plan view of a portion of a guide wire according to another
embodiment of the invention,
Fig. 27 is an end elevational view of the portion of the guide wire of Fig. 26,
Fig. 28 is a top plan view of a portion of a guide wire according to another
embodiment of the invention,
Fig. 29 is an end elevational view of the portion of the guide wire of Fig. 28,
Fig. 30 is a perspective view of the portion of the guide wire of Fig. 28,
Fig. 31 is a perspective view of a portion of a guide wire according to another
embodiment of the invention,
Fig. 32 is a perspective view of a part of the portion of the guide wire of Fig.
31 .
Fig. 33 is a perspective view of a portion of a guide wire according to another
embodiment of the invention,
Fig. 34 is a perspective view of a part of the portion of the guide wire of Fig.
33, '
Fig. 35 is a perspective view of a portion of a guide wire according to a
further embodiment of the invention,
Fig. 36 is a perspective view of a portion of a guide wire according to a still
further embodiment of the invention,
Fig. 37 is an end elevational view of the portion of the guide wire of Fig. 36,
Fig. 38 is a side elevational viewof a portion of a guide wire according to a
still further embodiment of the invention, and
Fig. 39 is atop plan view of the portion of the guide wire of Fig. 38.
Referring to the drawings and initially to Figs. 1 to 10, there is illustrated a guide wire
according to the invention, indicated generally by the reference numeral 1, for use in
a re-canalising process for re-canalising a vascular occlusion in a vascular system of
a human or animal subject. The guide wire 1 extends between a proximal end 3 and
a distal end 4 and comprises a core wire 5 of circular transverse cross-section and of
stainless steel material which extends from the proximal end 3 to the distal end 4,
and defines a longitudinally extending main central axis 6. A terminal member 7 of
circular transverse cross-section adjacent its proximal end portion 16 defines a
central axis 9, and is secured to the core wire 5 at its distal end 4, and extends
axially therefrom with the central axis 9 of the terminal member 7 coinciding with the
main central axis 6 of the core wire 5. The terminal member 7 tapers to a distal
leading edge portion, which in this embodiment of the invention is a transversely
extending elongated leading edge portion 8 in the form of a chisel edge for engaging
and penetrating the occlusion or partial occlusion in a vessel of the vascular system
as the guide wire 1 is urged through the vascular system. The leading edge portion
8 extends at 90° to the main central axis 6. A sleeve, in this embodiment of the
invention provided by a tightly wound helical coil 10 of stainless steel material is
secured to the terminal member 7 at the proximal end portion 16 thereof, and
extends therefrom over the core wire 5, and terminates at a location 11 intermediate
the proximal end 3 and the distal end 4 of the guide wire 1, but towards the distal
end 4. The helical coil 10 is of circular transverse cross-section, and defines a bore
12 of circular transverse cross-section.
The terminal member 7 is of radiopaque material, in this embodiment of the
invention platinum alloy, so that it is visible under X-rays as the guide wire 1 is being
urged through the vascular system. The outer diameter of the terminal member 7 at
its proximal end portion 16 is constant and is substantially similar to the outer
diameter of the helical coil 10 adjacent the terminal member 7 so that as a catheter
is being urged along the guide wire 1, the catheter can readily easily be urged over
the terminal member 7. The terminal member 7 defines a first surface portion 13
and a second surface portion 14 which converge towards each other and terminate
in the leading edge portion 8. In this embodiment of the invention the first and
second surface portions 13 and 14 are planar, and the leading edge portion 8 is
radiused, with a radius r, between the first and second surface portions 13 and 14 to
form the leading edge portion 8 to be convex in a plane perpendicular to a plane
containing the leading edge portion 8. The radius rof the convex surface 15 of the
leading edge portion 8 is sufficiently large to provide the leading edge portion 8 to be
sufficiently blunt to prevent the leading edge portion 8 penetrating a wall of a vessel
of the vascular system, but not so blunt as would prevent the leading edge portion 8
penetrating an occlusion or a partial occlusion in a vessel of the vascular system.
The first and second surface portions 13 and 14 define an included angle or, see Fig.
7, which is sufficiently acute for gradually opening the occlusion as the terminal
member 7 is urged therethrough, while at the same time avoiding detaching any of
the occluding material from the vessel, in order to avoid urging the occluding
material forwardly with the guide wire 1. The first and second surface portions 13
and 14 are joined by third and fourth surface portions 18 and 21, respectively. which
extend from the proximal end portion 16 of the terminal member 7 to the leading
edge portion 8. The third and fourth surface portions 18 and 21 are radiused, and
are of the same radius as the outer surface of the proximal end portion 16, and thus,
coincide with the outer surface of the proximal end portion 16, and are convex in a
transverse direction relative to the main central axis 6.
The first and second surface portions 13 and 14 define a central major plane 26
which bisects the included angle a defined by the first and second surface portions
and 14. In this embodiment of the invention the central major plane 26 defined by
the first and second surface portions 13 and 14 contains the main central axis 6 and
the leading edge portion 8. The transverse width of the leading edge portion 8 is
thus similar to the diameter of the proximal end portion 16 of the terminal member 7,
and furthermore, the transverse cross-section of the portion of the terminal member
formed by the first and second surface portions 13 and 14 is such as not to extend
beyond the outer transverse cross-sectional profile of the circular proximal end
portion 16 of the terminal member 7.
In this embodiment of the invention the included angle a defined by the first and
second surface portions 13 and 14 of the terminal member 7 is approximately 15°,
however, it is envisaged that the included angle or defined by the first and second
surface portions 13 and 14 may be any acute angle in the range 5° to 60°, although
it is believed that it is preferable that the acute angle or defined by the first and
second surface portions 13 and 14 should lie in the range 12° to 30°. In this
embodiment of the invention the radius rof the radiused convex surface 15 of the
leading edge portion of the terminal member 7 is approximately 0.075mm, although
it is envisaged that the radius of the radiused convex surface 15 may lie in the range
0.02mm to 0.14mm, although it is believed that it is preferable that the radius r
should lie within the range 0.05mm to 0.10mm.
A plug 17 extends axially from the terminal member 7 for engaging the bore 12 in the
helical coil 10 at the distal end thereof. The diameter of the plug 17 is such that the
difference between the diameter of the plug 17 and the diameter at the proximal end
portion 16 of the terminal member 7 is equal to twice the diameter of the wire
forming the helical coil 10, so that when the plug member 17 is engaged in the bore
12 of the helical coil 10, the outer surface defined by the helical coil 10 substantially
coincides with the outer surface of the proximal end portion 16 of the terminal
member 7. A bore 19 extends axially into the plug 17 and into the terminal member
7 for accommodating the distal end 4 of the core wire 5 for securing the terminal
member 7 to the core wire 5. In this embodiment of the invention the core wire 5
and the helical coil 10 are soldered to the terminal member 7 by solder 20 which fills
the bore 19 as well as a distal portion of the bore 12 of the helical coil 10 for securing
the terminal member 7 to the core wire 5 and the helical coil 10.
The core wire 5 commences to taper at a location 22 at the proximal side of the
location 11 at which the helical coil 10 terminates, and tapers to its distal end 4. In
this embodiment of the invention the core wire 5 tapers in steps as is illustrated in
Fig. 4. The core wire 5 tapers from the location 22 to a first portion 23 of constant
diameter, and tapers from the first portion 23 to a second portion 24 of constant
diameter, and in turn tapers from the second portion 24 to a third portion 25 of
constant diameter. A distal portion 28 extends from the third portion 25 at 29 to a
transversely extending distal tip 30, and is of spade-like configuration having a
rectangular transverse cross-section. The distal portion 28 defines a first major
surface 32 and a second major surface 33, which are joined by opposite minor
surfaces 34. The first and second major surfaces 32 and 33 converge towards each
other towards the distal tip 30, while the minor surfaces 34 diverge away from each
other towards the distal tip 30. The first and second major surfaces 32 and 33 define
therebetween a central major plane 35 which contains the transversely extending
distal tip 30 and the main central axis 6, and extends perpendicular to the minor
surfaces 34. The spade-like configuration of the distal portion 28 facilitates bending
of the guide wire at the distal portion 28 for urging the terminal member 7 out of the
central major plane 35 for facilitating aligning the guide wire 1 with a branching
vessel of the vascular system and directing the terminal member 7, and in turn the
guide wire 1 into the branching vessel.
A reinforcing means, in this embodiment of the invention provided by a reinforcing rib
36 extends longitudinally along the first major surface 32 of the distal portion 28 from
the location 29, and terminates at a location 37 intermediate the location 29 and the
distal tip 30 for minimising torsional twisting of the core wire along the distal portion
28. Where the distal portion 28 is to be bent for bending the terminal member 7 out
of the central major plane 35, the distal portion 28 is bent between the location 37
and the terminal member 7.
A portion 38 of the distal portion 28 of the core wire 5 may be curved in the central
major plane 35 as illustrated in Fig. 10 for directing the terminal member 7 out of a
central minor plane 39 defined between the minor surfaces 34 and containing the
main central axis 6 and extending perpendicularly of the first and second major
surfaces 32 and 33. Forming the curved portion 38 in the distal portion 28 also
facilitates aligning of the terminal member 7 with a branched vessel of the vascular
system, and directing the terminal member 7, and in turn, the guide wire 1 into the
branched vessel. When the guide wire 1 is provided with the distal portion 28 curved
at 38, the distal portion 28 could still be bent between the location 37 and the
terminal member 7 for directing the terminal member 7 out of the central major plane
. In this way, the terminal member 7 would be directed out of both the major and
minor central planes 35 and 39, respectively.
In practice, bending of the distal portion 28 between the location 37 and the terminal
member 7 for urging the terminal member 7 out of the central major plane 35 would
typically be carried out manually by a surgeon or a paramedic prior to inserting the
guide wire 1 into the subject. The curved portion 38 for directing the terminal
member 7 out of the central minor plane 39 would normally be factory formed.
The amount by which the curved portion 38 of the distal portion 28 is curved
determines the amount by which the terminal member 7 is offset from the central
major plane 35, in other words, the amount of curvature in the curved portion 38
determines the included angle 6 which the central axis 9 of the terminal member 7
makes with the main central axis 6, namely, the angular offset of the terminal
member 7 relative to the main central axis 6. in Fig. 10 the angle 6 is illustrated as
being 90°, however, it will be readily apparent to those skilled in the art that the angle
9 may be any desired angle, and typically will lie between 0° and 90°. The angle at
which the portion of the distal portion 28 between the location 37 and the terminal
member 7 may be bent may be any desired angle, and typically would be in the
range from 0° to 90°.
in this embodiment of the invention the terminal member 7 is secured to the distal
portion 28 of the core wire 5 with the central major plane 26 defined by the first and
second surface portions 13 and 14 extending perpendicularly to the central major
plane 35 defined by the first and second major surfaces 32 and 33 of the distal
portion 28 of the core wire 5. Accordingly, the leading edge portion 8 extends
perpendicularly to the central major plane 35 defined by the first and second major
surfaces 32 and 33 of the distal portion 28 of the core wire 5. This facilitates
bending of the flattened distal portion 28 in the direction of the arrows A and B, see
Fig. 6. However, it is envisaged that the terminal member 7 may be secured to the
core wire 5 with the central major plane 26 defined between the first and second
surface portions 13 and 14 of the terminal member 7 extending parallel to or
coinciding with the central major plane 35 defined between the first and second
major surfaces 32 and 33 of the distal portion 28 of the core wire 5. In which case
the leading edge portion 8 would extend parallel to or coincide with the central major
plane 35 defined by the first and second major surfaces 32 and 33 of the distal
portion 28 of the core wire 5.
In use, the guide wire 1 is urged through the vascular system of the subject towards
the occluded vessel. On reaching the occluded vessel, the guide wire is gradually
urged forward and the leading edge portion 8 of the terminal member 7 engages the
occlusion and commences penetration thereof. As the leading edge portion 8
penetrates the occlusion, the first and second surface portions 13 and 14 commence
to gradually open the occlusion, and further urging of the guide wire 1 causes the
terminal member 7 to open the occlusion with the diameter of the opening formed in
the occlusion corresponding to the diameter of the terminal member 7 adjacent the
guide wire 1. Further urging of the guide wire 1 through the occlusion maintains the
occlusion open with a diameter corresponding to that of the terminal member 7.
Thereafter a catheter (not shown) is passed over the guide wire 1 and is guided into
the occlusion. If the guide wire 1 is carrying a balloon, stent or other therapeutic
device, the device is located in the opening formed in the occlusion by the terminal
member 7, and the guide wire 1 and the catheter (not shown) are removed.
Prior to entering the guide wire 1 into the vascular system of the subject, the guide
wire 1 may be bent adjacent the terminal member 7 thereof by bending the distal
portion 28 between the location 37 and the terminal member 7 in the direction of the
arrows A or B for facilitating aligning of the terminal member 7 with a branched
vessel of the vascular system as the guide wire 1 is being urged through the
vascular system. Additionally, as mentioned above, the guide wire 1 may be
supplied with the curved portion 38 already formed in the distal portion 28 as
illustrated in Fig. 10, and if desired, the distal portion 28 may be bent between the
location 37 and the terminal member 7 for urging the terminal member 7 out of the
central major plane 35 for further enhancing alignment of the guide wire 1 with a
branched vessel of the vascular system.
It is also envisaged that the terminal member 7 may be provided with wells or holes
on its outer surface, in particular, along the first and second surface portions 13 and
14 for retaining therapeutic drugs or other compositions, liquid or otherwise, for
assisting in urging of the guide wire 1 through the vascular system, and in particular,
for assisting in urging the terminal member 7 through the occlusion or partial
occlusion. Such drugs or other compositions, which may be in liquid, powder or
other suitable form, may be drugs which would facilitate in dilation of a vessel, or
dissolving the material of the occlusion. For example, if the occlusion were caused
by a thrombosis, one of the drugs may be suitable for dissolving the thrombosis.
Referring now to Fig. 11, a terminal member, indicated generally by the reference
numeral 50, of a guide wire (not shown) also according to the invention is illustrated.
In this embodiment of the invention the core wire and sleeve of the guide wire are
similar to the core wire 5 and the sleeve 10 of the guide wire 1 of Figs. 1 to 10. The
terminal member 50 is substantially similar to the terminal member 7, and similar
components are identified by the same reference numerals. In this embodiment of
the invention a proximal portion 51 of the terminal member 50 is of outer circular
transverse cross—section, and the terminal member 50 terminates in a leading edge
portion 8 similar to the leading edge portion 8 of the tenninal member 7. However,
while an axial bore 19 extends into the terminal member 50 for engaging the distal
end 4 of the core wire 5, the terminal member 50 is provided without a plug similar to
the plug 17 of the terminal member 7. In this case the helical coil 10 would be
abutted against an end face 52, and would be brazed or soldered to the end face 52
with the outer surface defined by the helical coil coinciding with the outer surface
defined by the proximal portion 51 of the terminal member 50. The soldering or
brazing of the helical coil 10 to the end face 52 of the terminal member 50 could be
carried out simultaneously with soldering or brazing the core wire 5 into the bore 19
of the terminal member 50, or after the terminal member 50 had been brazed or
soldered to the core wire 5.
Referring now to Fig. 12, there is illustrated a terminal member 55 of a guide wire
(not shown) also according to the invention. In this embodiment of the invention the
core wire and the sleeve of the guide wire are similar to the core wire 5 and the
sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 55 is
substantially similar to the terminal member 7 and similar components are identified
by the same reference numerals. In this embodiment of the invention an axial plug
17 extends from the terminal member 55, however, the terminal member 55 is
provided without an axial bore similar to the axial bore 19 of the terminal member 7.
Thus, in this embodiment of the invention the axial plug 17 engages the bore 12,
helical coil 10, and the distal end of the core wire 5 is abutted against an end face 56
of the terminal member 55 and brazed or soldered thereto.
Referring now to Fig. 13, there is illustrated a terminal member 60 of a guide wire
(not shown) also according to the invention. In this embodiment of the invention the
core wire and the sleeve of the guide wire are similar to the core wire 5 and the
sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 60 is
substantially similar to the terminal member 7, and similar components are identified
by the same reference numerals. The terminal member 60 comprises a proximal
end portion 61 of circulartransverse cross-section. However, in this embodiment of
the invention the terminal member 60 comprises a first surface portion 62 which
converges towards a second surface portion 63, the outer transverse cross-sectional
profile of which coincides with the corresponding cross-sectional profile of the
proximal end portion 61. The first surface portion 62 is convex in the longitudinal
direction of the central axis 9 of the terminal member 60 and converges towards the
second surface portion 83 in a direction towards the leading edge portion 8 to form
with the second surface portion 63, the transversely extending leading edge portion
8. The surface 15 of the leading edge portion 8 is radiused between the first and
second surface portions 62 and 63, and defines one straight edge 64 adjacent the
first surface portion 62 and one arcuate edge 85 adjacent the second surface portion
63. Additionally, side edges 66 of the first surface portion 62 are radiused to merge
into the outer surface of the terminal member 60. In this embodiment of the
invention the straight edge 64 of the leading edge portion 8 is contained in a plane
which extends parallel to a plane containing the main central axis 6, but is offset
therefrom.
Otherwise, the terminal member 60 is substantially similar to the terminal member 1.
The advantage of the terminal member 60 is that since the straight edge 64 of the
leading edge portion 8 is offset from the main central axis 6, the guide wire
according to this embodiment of the invention can be guided through a vascular
system to access a space between layers of a vessel. This, thus, permits
angioplasty or other surgical procedures to be carried out in a new sub-intimal
lumen. Sub-intimal angioplasty is a technique where a lumen is created between the
layers of the vessel adjacent to the true lumen of the vessel.
Referring now to Fig. 14, there is illustrated a terminal member 70 of a guide wire
(not shown) also according to the invention. In this embodiment of the invention the
core wire and the sleeve of the guide wire are similar to the core wire 5 and the
sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 70 is
substantially similar to the terminal member 60 and similar components are identified
by the same reference numerals. The main difference between the terminal member
70 and the terminal member 60 is that the first surface portion 62 is concave instead
of convex. Othen/vise, the terminal member 70 is similar to the terminal member 60.
The advantage of providing the first surface portion 62 of concave shape as opposed
to convex shape is that probing by the terminal member 70 may initially have less
contact area due to the concave surface.
Referring now to Fig. 15, there is illustrated a terminal member 75 of a guide wire
(not shown) also according to the invention. In this embodiment of the invention the
core wire and the sleeve of the guide wire are similar to the core wire 5 and the
sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 75 is
substantially similar to the terminal member 60 and similar components are identified
by the same reference numerals. The main difference between the terminal member
75 and the terminal member 60 is that the first surface portion 62 is formed
sequentially by a proximal convex portion 76 and a distal concave portion 77.
Additionally, the terminal member 75 is of a magnetic material. in this embodiment of
the invention a ferrous material, so that the terminal member 75 can be urged
through the vascular system, and also through an occlusion in a vessel of the
vascular system by a magnetic field generated by a magnetic urging means (not
shown), which would be located externally of the subject. Such an urging means.
typically, would develop a magnetic field which could be moved and/or directed for
urging the terminal member 75, and in turn, the guide wire (not shown) through the
vascular system. Otherwise, the terminal member 75 is similar to the terminal
member 60.
The advantage of providing the terminal member 75 of a magnetic material is that
the member can be urged through the vascular system by an externally generated
magnetic field, rather than by urging the terminal member 75 through the vascular
system by pushing the guide wire ‘I into the subject. By virtue of the fact that the
terminal member 75 is urged by a magnetic field through the vascular system, rather
than by pushing the guide wire 1 into the subject, minimises the danger of the
terminal member 75 puncturing a vessel of the vascular system as the terminal
member 75 is being urged therethrough. Additionally, by virtue of the fact that the
guide wire is being pulled rather than being pushed, the guide wire can be provided
with considerably more flexibility than could othen/vise be provided if the guide wire
were being pushed through the vascular system.
Referring now to Figs. 16 to 18, there is illustrated a terminal member 80 of a guide
wire also according to the invention, only a distal end portion 81 of the guide wire is
illustrated. In this embodiment of the invention the core wire of the guide wire, the
distal portion 28 of which is illustrated, and the sleeve 10, the distal portion also of
which is illustrated, are similar to the core wire 5 and the sleeve 10 of the guide wire
1 of Figs. 1 to 10. The terminal member 80 is also substantially similarto the
terminal member 7 described with reference to Figs. 1 to 10, and similar components
are identified by the same reference numerals. In this embodiment of the invention
the terminal member 80 is essentially formed by solder 82. The distal portion 28 of
the core wire 5 extends beyond the sleeve 10, and is soldered to the sleeve 10 by
the solder 82 which forms the terminal member 80. The leading edge portion 8 of
the terminal member 80 is formed by a distal end 83 of the distal portion 28 of the
core wire 5, and the solder 82 is shaped to form the first, second, third and fourth
surface portions 13, 14, 18 and 21, respectively. However, in this embodiment of the
invention the outer surface of the terminal member 80 at the proximal end portion 16
of the terminal member 80 formed by the solder 82 is of circular cross-section, and is
of similar diameter to the outer diameter of the sleeve 10. Additionally, as well as
the first and second surface portions 13 and 14 tapering towards the leading edge
portion 8 of the terminal member 80, the third and fourth surface portions 18 and 21
also taper from the proximal end portion 16 of the terminal member 80 to the leading
edge portion 8. The first, second, third and fourth surface portions 13, 14, 18 and
21, respectively, are radiused surfaces, and thus, are convex in transverse cross-
section relative to the main central axis 6. The distal portion 28 of the guide wire 5 is
centrally located in the sleeve 10, and accordingly, the plane containing the leading
edge portion 8 also contains the main central axis 6 of the guide wire.
Othen/vise, the guide wire and the terminal member 80 according to this embodiment
of the invention is similar to the guide wire 1 and the terminal member 7, and their
use is similar to that described with reference to the guide wire 1 of Figs. 1 to 10.
Referring now to Figs. 19 to 21, there is illustrated a terminal member 85 of a guide
wire (not shown) also according to the invention. In this embodiment of the invention
the core wire and the sleeve of the guide wire are similar to the core wire 5 and the
sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 85 is
substantially similar to the terminal member 7 of the guide wire 1 of Figs. 1 to 10,
and similar components are identified by the same reference numerals. The main
difference between the terminal member 85 and the terminal member 7 is that in the
terminal member 85 the leading edge portion 8 extends at an angle (p to the main
central axis 6, which in this embodiment of the invention is approximately 70°.
Otherwise, the terminal member 85 and its use in conjunction with a guide wire is
similar to the terminal member 7 of the guide wire 1 described with reference to Figs.
1 to 10.
Referring now to Figs. 22 and 23, there is illustrated a terminal member 90 of a
guide wire (not shown) also according to the invention. In this embodiment of the
invention the core wire and the sleeve of the guide wire are similar to the core wire 5
and the sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 90 is
substantially similar to the terminal member 7 described with reference to Figs. 1 to
and similar components are identified by the same reference numerals. The
main difference between the terminal member 90 and the terminal member 7 is that
firstly, the leading edge portion 8 extends at an angle (p to the main central axis 6,
which in this embodiment of the invention is approximately 60°, and secondly, the
third and fourth surface portions 18 and 21 converge from the proximal end portion
16 of the terminal member 90 to the leading edge portion 8. In this embodiment of
the invention the first, second, third and fourth surface portions 13, 14, 18 and 21 are
radiused, and thus are convex in a transverse direction relative to the main central
axis 6.
Otherwise, the terminal member 90 is similar to the terminal member 7.
Referring now to Figs. 24 and 25, there is illustrated a terminal member 95 of a
guide wire (not shown) also according to the invention. In this embodiment of the
invention the core wire and sleeve of the guide wire are similar to the core wire 5 and
the sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 95 is
substantially similar to the terminal member 7, and similar components are identified
by the same reference numerals. The main difference between the terminal member
95 and the terminal member 7 is that the leading edge portion 8 is radiused in plan
view, and thus, is convex in plan view. Otherwise, the terminal member 95 is similar
to the terminal member 7.
Referring now to Figs. 26 and 27, there is illustrated a terminal member 100 of a
guide wire (not shown) also according to the invention. In this embodiment of the
invention the core wire and the sleeve of the guide wire are similar to the core wire 5
and the sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 100 is
substantially similar to the terminal member 7, and similar components are identified
by the same reference numerals. The main difference between the terminal member
100 and the terminal member 7 is that the leading edge portion 8 is radiused in plan
view, and in this embodiment of the invention is concave in plan view. Otherwise,
the terminal member 100 is similar to the terminal member 7.
Referring now to Figs. 29 to 30, there is illustrated a terminal member 105 of a guide
wire (not shown) also according to the invention. In this embodiment of the invention
the core wire and the sleeve of the guide wire are similar to the core wire 5 and the
sleeve 10 of the guide wire of Figs. 1 to 10. The terminal member 105 is
substantially similar to the terminal member 7, and similar components are identified
by the same reference numerals. The main difference between the terminal member
105 and the terminal member 7 is that the portion of the terminal member which
extends between the proximal end portion 16 and the leading edge portion 8 along
which the first and second surface portions 13 and 14 taper towards the leading
edge portion is twisted through an angle of approximately 90°. Otherwise, the
terminal member 105 is similar to the terminal member 7, and the use of the terminal
member 105 and its guide wire is similar to the guide wire 1 described with reference
to Figs. 1 to 10.
Referring now to Figs. 31 and 32, there is illustrated a terminal member 110 of a
guide wire also according to the invention, only a distal portion 111 of the guide wire
is illustrated in Figs. 31 and 32. In this embodiment of the invention the core wire,
the distal portion 28 of which is illustrated and the sleeve, a distal portion 10 of which
is illustrated, of the guide wire are similar to the core wire 5 and the sleeve 10 of the
guide wire 1 of Figs. 1 to 10. The terminal member 110 is substantially similar to the
terminal member 7 of the guide wire 1 of Figs. 1 to 10, and similar components are
identified by the same reference numerals. Additionally, the terminal member 110 of
this embodiment of the invention is somewhat similar to the terminal member 80
described with reference to Figs. 16 to 18. In this embodiment of the invention the
terminal member 110 is essentially formed by solder 112 which solders the distal
portion 28 of the guide wire to the sleeve 10 of the guide wire. The main difference
between the terminal member 110 and the terminal member 80 is that in this
embodiment of the invention the distal portion 28 of the core wire is wider than the
distal portion of the guide wire of Figs. 16 to 18, and thus, the leading edge portion 8
of the terminal member 110 is longer than the leading edge portion 8 of the terminal
member 80. Additionally, the reinforcing rib 36 of the distal portion 28 of the core
wire 5, in this embodiment of the invention, extends into the terminal member 110.
The solder 112 is shaped to form the terminal member 110 in similar fashion as the
solder 82 is shaped to form the terminal member 80.
Otherwise, the terminal member 110 is similar to the terminal member 80, which in
turn is substantially similar to the terminal member 7.
Referring now to Figs. 33 and 34, there is illustrated a terminal member 115 of a
guide wire also according to the invention, only a distal end 116 of the guide wire is
illustrated. In this embodiment of the invention the core wire and sleeve of the guide
wire are similar to the core wire 5 and the sleeve 10 of the guide wire 1 of Figs. 1 to
. The terminal member 115 is substantially similar to the terminal member 110,
which in turn is substantially similar to the terminal member 7, and similar
components are identified by the same reference numerals. The main difference
between the terminal member 115 and the terminal member 110 is that a distal
portion extension 119 is secured to the distal portion 28 of the core wire 5, and is not
centrally located in the sleeve 10. Rather, the distal portion extension 119 defines a
central major plane 135, which is parallel to but offset from a plane containing the
main central axis 6. As in the case of the terminal member 110, the terminal
member 115 is essentially formed by solder 117, and accordingly, by virtue of the
fact that the distal portion extension 119 is offset from the main central axis 6, the
leading edge portion 8 of the terminal member 115, which is formed by a distal end
118 of the distal portion extension 119 of the core wire 5, is contained in a plane
which extends parallel to a plane containing the main central axis 6 of the core wire,
but is offset therefrom. Otherwise, the terminal member 115 is substantially similar
to the terminal member 110, which in turn is substantially similar to the terminal
member 7.
Referring now to Fig. 35, there is illustrated a terminal member 120 of a guide wire
(not shown) also according to the invention. In this embodiment of the invention the
core wire and the sleeve of the guide wire are similar to the core wire 5 and sleeve
of the guide wire 1 of Figs. 1 to 10. The terminal member 120 is substantially
similar to the terminal member 7, and similar components are identified by the same
reference numerals. The main difference between the terminal member 120 and the
terminal member 7 is that in this embodiment of the invention only the first surface
portion 13 is angled to converge with the second surface portion 14. Otherwise, the
terminal member 120 is similar to the terminal member 7.
Referring now to Figs. 36 and 37, there is illustrated a terminal member 125 of a
guide wire (not shown) also according to the invention. In this embodiment of the
invention the core wire and the sleeve of the guide wire are similar to the core wire 5
and the sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 125 is
substantially similar to the terminal member 7, and similar components are identified
by the same reference numerals. The main difference between the terminal member
125 and the terminal member 7 is that a leading portion 126 of the terminal member
125 is of wedge shape construction, and extends from an intermediate portion 127
which is located between the proximal end portion 16 and the leading portion 126.
The leading portion 126 defines the leading edge portion 8 which extends
transversely relative to the main central axis 6 of the guide wire, and is contained in
to
U:
a plane which also contains the main central axis 6.
The first and second surface portions 13 and 14 extend from the proximal end
portion 16 to the leading edge portion 8 and converge along the intermediate portion
127 and the leading portion 126. However, the portion of the first and second
surface portions 13 and 14 which are defined by the intermediate portion 127 are
radiused, and thus, convex in a direction transversely of the main central axis 6,
while the portion of the first and second surface portions 13 and 14 defined by the
leading portion 126 are planar surfaces. The third and fourth surface portions 18
and 21, which are defined by the leading portion 126 are planar surfaces, and
extend parallel to each other. However. the portions of the third and fourth surface
portions 18 and 20 which are defined by the intermediate portion 127 converge from
the proximal end portion 16 to the leading portion 126. The third and fourth surface
portions 18 and 21 which are defined by the intermediate portion 127 are radiused,
and thus, convex in a direction transversely of the main central axis 6 of the guide
wire.
Othenmise, the terminal member 127 is similar to the terminal member 7.
Referring now to Figs. 38 and 39, there is illustrated a terminal member 140 of a
guide wire (not shown) also according to the invention. In this embodiment of the
invention the core wire and the sleeve of the guide wire are similar to the core wire 5
and the sleeve 10 of the guide wire 1 of Figs. 1 to 10. The terminal member 140 is
substantially similar to the terminal member 7, and similar components are identified
by the same reference numerals. The main difference between the terminal member
140 and the terminal member 7 is that the acute angle cx defined by the first and
second surface portions 13 and 14 is less than the acute angle oi defined by the first
and second surface portions 13 and 14 of the terminal member 7, and accordingly,
the length of the first and second surface portions 13 and 14 between the proximal
end portion 16 and the leading edge portion 8 is longer in the terminal member 140
than it is in the terminal member 7. Additionally, the portion of the terminal member
140 extending between the proximal end portion 16 and the leading edge portion 8 is
bent at an angle [3 out of the central major plane 26 defined by the first and second
surface portions 13 and 14, so that the leading edge portion 8 is offset from the main
central axis 6, for facilitating guiding of the terminal member 140, and in turn the
guide wire into a branching vessel. Otherwise, the terminal member 140 is similar to
the terminal member 7, and its use along with the guide wire according to this
embodiment of the invention is similar to that of the guide wire 1 described with
reference to Figs. 1 to 10.
While the guide wire according to the invention has been described for use in
opening an occluded vessel in the cardiovascular system of a human or animal
subject, it will be readily apparent to those skilled in the art that the guide wire
according to the invention may be used for opening a vascular occlusion in any other
vascular system of the human or animal body.
While the sleeve extending around the core wire 5 adjacent its distal end has been
described as being provided by a helical coil, any other suitable sleeve may be
provided, for example, in certain cases, it is envisaged that the sleeve may be
provided as a sleeve of plastics material, composite polymer material, or any other
polymer material.
It will be appreciated that the guide wire may be produced of materials other than
those described, for example, the core wire may be of any other suitable material
besides stainless steel, for example, nickel titanium alloy, MP35N, composite
polymers, and the like. Similarly, the helical coil or other sleeve may be of any other
suitable material besides stainless steel, for example, nickel titanium alloy, MP35N,
composite polymers, and the like, and the terminal member may be of any other
material besides platinum alloy, however, it is preferable that the terminal member or
a portion thereof or a portion of the guide wire adjacent the terminal member should
be of a radiopaque material. Where the terminal member is of a magnetic material,
the magnetic material may be any other suitable magnetic material besides that
described with reference to the terminal member 75 of Fig. 15. Indeed, in certain
cases it is envisaged that the terminal member may be constructed only partly of a
magnetic material. However, it is preferable that the terminal member, even where it
is of a magnetic material, should be of a radiopaque material for facilitating tracking
of the terminal member as it is being urged through the vascular system.
Needless to say, while only the terminal member 75 has been described as being of
a magnetic material, it will be readily apparent to those skilled in the art that any of
the other terminal members described may be of a magnetic material.
Needless to say, any other suitable securing means for securing the terminal
member to the core wire and to the helical coil or other sleeve may be used besides
soldering and brazing. Indeed, in certain cases, it is envisaged that the terminal
member may be secured to the core wire and the helical coil or other sleeve by
welding, adhesive or any other suitable securing means. It is also envisaged in
certain cases that the terminal member may be integrally formed with the core wire
from the same material.
Furthermore, while the terminal member in some of the embodiments of the
invention described with reference to the drawings has been described as being
formed or partly formed by solder, it will be appreciated that instead of the terminal
member being formed or partly formed by solder, it may be formed or partly formed
by any other suitable material, for example, a brazing material, a welding material,
indeed, by an adhesive or any other suitable filler material.
it is also envisaged that while in some of the embodiments of the invention described
with reference to the drawings the terminal member has been described as having a
bore extending into the terminal member for engaging the distal portion of the core
wire, in certain cases, it is envisaged that a plug portion may extend from the
terminal member for securing to the distal portion of the core wire by any suitable
securing means, for example, soldering, brazing, welding or adhesive. In which
case, it is envisaged that, in general, the plug portion would be a relatively flat
member in order to abut and lie parallel to one of the major surfaces of the distal
portion of the core wire.
Additionally, while the terminal members of the guide wires described with reference
to the drawings in general have been described as having first and second surface
portions joined by third and fourth surface portions, which extend to the leading edge
portion from the proximal end portion, it is envisaged in certain cases that a portion
of the first surface portion may be formed by portions of the third and fourth surface
portions, so that when viewed from the distal end of the terminal member in the
direction of the proximal end thereof, the transverse cross-section of the terminal
member would be substantially triangular. The base of the triangle forming the
second surface portion and the leading edge portion, while the two sides of the
triangle would form the third and fourth surface portions, or the first surface portion,
depending on how the temiinal member is viewed. In which case, it is envisaged
that the surface portion of the terminal member forming the base of the triangle may
be planar or convex when viewed in a transverse direction, and the portions of the
surface of the terminal member forming the two sides of the triangle may be planar
or convex when viewed in a transverse direction. in such cases, the first surface
portion may be formed by the apex of the triangle defined by the third and fourth
sides thereof, and the apex may be radiused or not radiused.
It is also envisaged that the third and fourth surface portions of the terminal member
may be planar, convex or concave in a longitudinal direction, or may be a
combination of one or more of planar, concave and convex in a longitudinal
direction.
Claims (5)
1. A guide wire for use in a re-canalising process for re-canalising a vascular occlusion in a human or animal subject, the guide wire extending between a proximal end and a distal end, and defining a longitudinally extending main central axis, and a terminal member extending axially from the guide wire adjacent the distal end thereof and tapering to a distal leading edge portion for engaging and gradually opening the occlusion as the terminal member is urged therethrough, the leading edge portion extending at an angle to the main central axis.
2. A guide wire as claimed in Claim 1 in which the leading edge portion extends at an angle in the range of 30° to 90° to the main central axis.
3. A guide wire as claimed in Claim 1 or 2 in which the leading edge portion is an elongated leading edge portion.
4. A guide wire as claimed in any preceding claim in which at least a portion of the terminal member is of a magnetic material for facilitating urging of the terminal member through a vascular system by a magnetic urging means located externally of the subject.
5. A guide wire for use in a re-canalising process for re-canalising a vascular occlusion in a human or animal subject, the guide wire being substantially as described herein with reference to and as illustrated in the accompanying drawings. F.F. GORMAN & CO.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IEIRELAND26/03/2004S2004/0201 |
Publications (2)
Publication Number | Publication Date |
---|---|
IE20050164U1 IE20050164U1 (en) | 2005-11-30 |
IES84321Y1 true IES84321Y1 (en) | 2006-08-23 |
Family
ID=
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