U.S. patent application number 16/397826 was filed with the patent office on 2019-08-15 for sheathless guide catheter assembly.
The applicant listed for this patent is Medtronic Vascular, Inc.. Invention is credited to Joseph Berglund, William Berthiaume, Conor Flannery, H. Allan Steingisser, Maria Valdovinos.
Application Number | 20190247085 16/397826 |
Document ID | / |
Family ID | 57249899 |
Filed Date | 2019-08-15 |
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United States Patent
Application |
20190247085 |
Kind Code |
A1 |
Steingisser; H. Allan ; et
al. |
August 15, 2019 |
Sheathless Guide Catheter Assembly
Abstract
A guide catheter assembly includes a dilator and a guide
catheter. The dilator includes a dilator lumen extending from a
distal opening at a distal end to a proximal opening at a proximal
end, and a side exit port proximal of the distal opening and in
communication with the dilator lumen. The guide catheter includes a
proximal end, a distal end, and a guide lumen extending
therebetween. The dilator and the guide lumen are sized such that
the dilator can pass through the guide lumen. The dilator and the
guide catheter are sized such that with the proximal end of the
dilator generally aligned along an axis with the proximal end of
the guide catheter, the distal end of the dilator extends distally
past the distal end of the guide catheter and the side exit port is
disposed distal of the distal end of the guide catheter.
Inventors: |
Steingisser; H. Allan;
(Santa Rosa, CA) ; Berthiaume; William; (Santa
Rosa, CA) ; Berglund; Joseph; (Santa Rosa, CA)
; Flannery; Conor; (Oakland, CA) ; Valdovinos;
Maria; (Santa Rosa, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Family ID: |
57249899 |
Appl. No.: |
16/397826 |
Filed: |
April 29, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14922355 |
Oct 26, 2015 |
10271873 |
|
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16397826 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0102 20130101;
A61M 25/0068 20130101; A61M 2025/018 20130101; A61M 25/0662
20130101; A61M 25/09 20130101; A61B 17/34 20130101; A61M 2025/0079
20130101; A61M 29/00 20130101 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61M 25/01 20060101 A61M025/01; A61M 29/00 20060101
A61M029/00; A61M 25/06 20060101 A61M025/06; A61M 25/09 20060101
A61M025/09; A61M 25/00 20060101 A61M025/00 |
Claims
1-8. (canceled)
9. A guide catheter assembly comprising: a dilator including a
proximal end, a distal end, a dilator lumen extending from a distal
opening at the distal end to a side exit port proximal of the
distal opening, wherein the dilator includes a tapered distal
portion adjacent the distal end; and a guide catheter including a
proximal end, a distal end, and a guide lumen extending between the
proximal end and the distal end of the guide catheter, wherein the
dilator and the guide lumen are sized such that the dilator can
pass through the guide lumen, and wherein the dilator and guide
catheter are sized such that with the proximal end of the dilator
generally aligned along an axis along an axis with the proximal end
of the guide catheter, the distal end of the dilator extends
distally past the distal end of the guide catheter and the side
exit port is disposed distal of the distal end of the guide
catheter.
10. The guide catheter assembly of claim 9, wherein the dilator
lumen is sized to receive a nominal 0.018-0.021 inch guidewire.
11. The guide catheter assembly of claim 9, wherein the guide
catheter is 90-150 cm long and the dilator is longer than the guide
catheter.
12. The guide catheter assembly of claim 9, wherein the tapered
distal portion of the dilator is formed of a soft material to
minimize trauma with a patient's vasculature.
13. A method for accessing a vessel and delivering a guide catheter
to a desired location in the vasculature of a patient, the method
comprising the steps of: inserting a needle through a wall of the
vessel at an access site to create an access opening, wherein the
needle includes a needle lumen; inserting a first wire through the
needle lumen and into the vessel, wherein the first wire has a
first diameter; removing the needle from the vessel over the first
wire and leaving a distal end of the first wire in a lumen of the
vessel with the first wire extending through the access opening;
inserting a proximal end of the first wire into a distal opening of
a dilator of a guide catheter assembly and into a dilator lumen of
the dilator, wherein the guide catheter assembly includes the
dilator and a guide catheter having a guide lumen sized to receive
the dilator therein; guiding the proximal end of the first wire out
of a side exit port of the dilator, wherein the side exit port is
located proximal of the distal opening and distal of a distal end
the guide catheter when a proximal end of the dilator and a
proximal end of guide catheter are generally aligned along an axis;
advancing the guide catheter assembly over the first wire until a
distal portion of the dilator enters the vessel; and removing the
first wire from the vessel and the dilator by pulling the proximal
end of the first wire such that the first wire retracts from the
vessel, through the distal opening, and out of the side exit
port.
14. The method of claim 13, further comprising the step of
withdrawing the dilator through the guide lumen after the distal
portion of the guide catheter is disposed in the vessel.
15. The method of claim 14, further comprising the step of
advancing the guide catheter to the desired location in the
vasculature.
16-20. (canceled)
21. The method of claim 14, further comprising the step of, after
withdrawing the dilator through the guide lumen, inserting a second
guidewire into a proximal opening at the proximal end of the guide
catheter, through the guide lumen, and out of a distal opening at
the distal end of the guide catheter into the vessel.
22. The method of claim 14, wherein the second guidewire has a
second diameter larger than the first diameter of the first
guidewire.
23. The method of claim 22, wherein the first guidewire has a
nominal diameter of 0.018-0.021 inch and the second guidewire has a
nominal diameter of 0.035 or 0.038 inch.
24. The method of claim 13, wherein the dilator lumen extends only
from the distal opening to the side exit port.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/922,355, filed Oct. 26, 2015, now U.S. Pat. No.
10,271,873, the contents of which are incorporated by reference
herein in their entirety.
FIELD OF THE INVENTION
[0002] Embodiments hereof relate to sheathless guide catheter
assemblies and methods of using such sheathless guide catheter
assemblies.
BACKGROUND OF THE INVENTION
[0003] Percutaneous transluminal catheterization procedures such as
angioplasty, stent implantation, stent-graft implantation, and
other prosthesis implantations require minimally invasive access to
a patient's vasculature. Generally access is into an artery such as
the common femoral artery using the Seldinger technique. A guide
catheter is then advanced over a guidewire to a desired site in the
vasculature near a treatment site. Procedural devices may then be
advanced through the guide catheter to the treatment site.
[0004] The process for gaining repeated access to the vessel can
include several steps with a hollow needle, medical guidewires,
guidewire exchanges, introducer sheaths, and exchanges thereof.
Such steps may cause trauma to the vessel. While using an
introducer sheath typically reduces tissue damage from catheter
exchanges therethrough, the sheath requires a larger
puncture/access opening, which takes longer to close after the
procedure. So-called "sheathless" procedures have been introduced
which use smaller diameter introducer sheaths. However, sheaths are
still used, which require additional exchanges and can cause trauma
to the access site of the vessel.
[0005] Accordingly, there is a need for devices and methods for
guide catheter access to a vessel which reduce the number of steps
to access the vessel and reduce trauma to the vessel at the access
site.
BRIEF SUMMARY OF THE INVENTION
[0006] Embodiments hereof are directed to a guide catheter assembly
including a dilator and a guide catheter. The dilator includes a
proximal end, a distal end, a dilator lumen extending from a distal
opening at the distal end to a proximal opening at the proximal
end, and a side exit port proximal of the distal opening. The side
exit port is in communication with the dilator lumen. The guide
catheter includes a proximal end, a distal end, and a guide lumen
extending between the proximal and distal ends of the guide
catheter. The dilator and the guide lumen are sized such that the
dilator can pass through the guide lumen. The lengths of the
dilator and the guide catheter are sized such that with the
proximal end of the dilator generally aligned along an axis with
the proximal end of the guide catheter, the distal end of the
dilator extends distally past the distal end of the guide catheter
and the side exit port is disposed distal of the distal end of the
guide catheter.
[0007] Embodiments hereof are also directed to a guide catheter
assembly including a guide catheter and a dilator. The dilator
includes a proximal end, a distal end, and a dilator lumen
extending from a distal opening at the distal end to a side exit
port proximal of the distal opening. The dilator includes a tapered
distal portion adjacent the distal end. The guide catheter includes
a proximal end, a distal end, and a guide lumen extending between
the proximal end and the distal end of the guide catheter. The
dilator and the guide lumen are sized such that the dilator can
pass through the guide lumen. The lengths of the dilator and guide
catheter are sized such that with the proximal end of the dilator
generally aligned along an axis with the proximal end of the guide
catheter, the distal end of the dilator extends distally past the
distal end of the guide catheter and the side exit port is disposed
distal of the distal end of the guide catheter.
[0008] Embodiments hereof are also directed to a method for
accessing a vessel and delivering a guide catheter to a desired
location in the vasculature of a patient. The method includes
inserting a needle through a wall of the vessel at an access site
to create an access opening, wherein the needle includes a needle
lumen. A first wire is inserted through the needle lumen and into
the vessel. The first wire has a first diameter. The needle is then
removed from the vessel over the first wire, thereby leaving a
distal end of the first wire in a lumen of the vessel with the
first wire extending through the access opening. A proximal end of
the first wire is inserted into a distal opening of a dilator of a
guide catheter assembly and into a dilator lumen of the dilator,
wherein the guide catheter assembly includes the dilator and a
guide catheter having a guide lumen sized to receive the dilator
therein. The proximal end of the first wire is guided out of a side
exit port of the dilator. The side exit port is located proximal of
the distal opening and distal of a distal end the guide catheter
when a proximal end of the dilator and a proximal end of guide
catheter are generally aligned along an axis. The guide catheter
assembly is advanced over the first wire until a distal portion of
the dilator enters the vessel. The first wire is removed from the
vessel and the dilator by pulling the proximal end of the first
wire such that the first wire retracts from the vessel, through the
distal opening, and out of the side exit port. A second guidewire
is inserted into a proximal opening at a proximal end of the
dilator, through the dilator lumen, and out of the distal opening
into the vessel. The guide catheter assembly is advanced over the
second guidewire until a distal portion of the guide catheter is
disposed in the lumen of the vessel. The dilator may be withdrawn
through the guide lumen after the distal portion of the guide
catheter is disposed in the vessel.
BRIEF DESCRIPTION OF DRAWINGS
[0009] The foregoing and other features and advantages of the
invention will be apparent from the following description of
embodiments hereof as illustrated in the accompanying drawings. The
accompanying drawings, which are incorporated herein and form a
part of the specification, further serve to explain the principles
of the invention and to enable a person skilled in the pertinent
art to make and use the invention. The drawings are not to
scale.
[0010] FIG. 1 is a broken longitudinal cross-section of a guide
catheter assembly according to an embodiment hereof.
[0011] FIG. 2 is a broken longitudinal cross-section of the guide
catheter assembly of FIG. 1 with an optional obturator shown.
[0012] FIG. 3 is a broken longitudinal cross-section of the guide
catheter assembly of FIG. 1 with an optional removable short wire
tube shown.
[0013] FIG. 4 is a broken longitudinal cross-section of a guide
catheter assembly according to another embodiment hereof.
[0014] FIGS. 5-13 illustrate a method of accessing a vessel with
the guide catheter assembly of FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0015] Specific embodiments of the present invention are now
described with reference to the figures, wherein like reference
numbers indicate identical or functionally similar elements. The
terms "distal" and "proximal" when used in the following
description to refer to a catheter or dilator are with respect to a
position or direction relative to the treating clinician. Thus,
"distal" and "distally" refer to positions distant from or in a
direction away from the clinician and "proximal" and "proximally"
refer to positions near or in a direction toward the clinician.
[0016] FIG. 1 shows a guide catheter assembly 100 according to an
embodiment hereof. Guide catheter assembly 100 includes a guide
catheter 110 and a dilator 150. Guide catheter 110 includes a
generally tubular guide shaft 111 including a distal end 112, a
proximal end 114, and a guide lumen 116 extending through guide
shaft 111. Guide lumen 116 extends from a proximal opening 115 at
proximal end 114 to a distal opening 113 at distal end 112. Guide
lumen 116 is sized such that dilator 150 can be removably disposed
therethrough, as explained in more detail below. Guide catheters
110 are commonly available in a range of sizes, e.g. outer
diameters, which are labeled according to the French gauge system,
and the guide lumens 116 range in size correspondingly. For example
only, a 5F guide catheter 110 is available from at least one
manufacturer with a guide lumen 116 measuring 0.058 inch.
Similarly, a 6F guide catheter 110 is available from at least one
manufacturer with a guide lumen 116 measuring 0.071 inch. A 7F
guide catheter 110 is available from at least one manufacturer with
a guide lumen 116 measuring 0.081 inch. An 8F guide catheter 110 is
available from at least one manufacturer with a guide lumen 116
measuring 0.090 inch.
[0017] Guide catheter 110 may be substantially straight, or guide
catheter 110 may include a curve (not shown) proximate the distal
region of guide catheter 110. Any one of a number of pre-formed
curve shapes may be incorporated into guide catheter 110, such as
Judkins-type or Amplatz-type curves, as non-limiting examples. Such
a curve may be pre-formed utilizing various known methods
including, but not limited to, the method disclosed in U.S. Pat.
No. 5,902,287 entitled "Guiding Catheter and Method of Making
Same." A desired curve may be manually created from a straight or
pre-formed distal region of guide catheter 110 by manipulation of
one or more steering wires, as known in the art.
[0018] In the embodiment shown, guide catheter 110 includes a hub
120 at proximal end 114. However, hub 120 may be a separate piece
coupled to guide shaft 111 of guide catheter 110. In the embodiment
shown an inner surface of guide shaft 111 at proximal end 114
includes threads 122 which are configured to mate with threads 162
on an outer surface of dilator 150, as explained in more detail
below. Guide catheter 110 and/or hub 120 may include other
features, such as, but not limited to, steering mechanisms,
additional lumens, etc.
[0019] Guide shaft 111 may be constructed from any suitable
materials known to those of ordinary skill in the field of guide
catheters. Material examples include, but are not limited to
polyethylene (PE), polyurethane, and polyethylene block amide
copolymer (PEBA). Guide catheters commonly include inner and outer
polymer layers with a reinforcement layer interposed
therebetween.
[0020] Dilator 150 includes a generally tubular dilator shaft 151
including a distal end 152, a proximal end 154, and a dilator lumen
156 extending through dilator shaft 151. Dilator 150 may also be
referred to as a leader or a flexible leader, especially where the
intended method of use is to leave the dilator extending distally
from the guide catheter while the assembly is navigated through the
patient's vasculature. Dilator lumen 156 extends from a proximal
opening 155 at proximal end 154 to a distal opening 153 at distal
end 152. Dilator lumen 156 is sized such that a guidewire may be
disposed therethrough, as explained in more detail below. Further,
dilator shaft 151 is sized such that an outer diameter of dilator
shaft 151 may have a close sliding fit within guide lumen 116. In
an embodiment dilator lumen 156 is sized to receive a nominal 0.035
or 0.038 inch guidewire. The term "nominal" as used herein means
that the guidewire is referred to in the industry by the diameter
named (in this case, 0.035 or 0.038 inch). However, the actual
diameter of the guidewire may vary up to 10% of the nominal size.
In an embodiment, dilator lumen 156 has a diameter in the range of
0.015-0.040 inch.
[0021] Dilator 150 is longer than guide catheter 110 such that
dilator 150 is configured to protrude from distal opening 113 of
guide catheter 110. As can be seen in FIG. 1, with proximal end 154
of dilator 150 generally aligned along an axis with proximal end
114 of guide catheter 110, distal end 152 of dilator 150 extends
distally beyond distal end 112 of guide catheter 112. The term
"generally aligned along an axis" as used herein means that the
proximal end 154 of dilator 150 is positioned on a common axis at
or proximal to the same location as the proximal end 114 of guide
catheter 110.
[0022] Dilator 150 also includes a side exit port 158, as shown in
FIG. 1. Side exit port 158 is an opening through dilator shaft 151
from an outer surface 164 of dilator shaft 151 through an inner
surface 166 of dilator shaft 151. Thus, side exit port 158 may also
be referred to as a through-hole and provides a passageway for
fluid communication or device movement between the outside of
dilator shaft 151 to dilator lumen 156. Side exit port 158 is
located between proximal opening 155 and distal opening 153. More
particularly, with dilator 150 disposed through guide lumen 116 of
guide catheter 110 and with proximal end 154 of dilator 150
generally aligned along an axis with proximal end 114 of guide
catheter 110, as explained above, side exit port 158 is disposed
between distal opening 153 of dilator 150 and distal opening 113 of
guide catheter 110. A distance D1 from distal opening 153 to side
exit port 158 is sufficient such that, when distal end 152 is
disposed in a vessel of a patient's vasculature, side exit port 158
remains outside of the patient's body. Commercial guide catheters
are available in a range of lengths, beginning as short as 30 cm,
but typically measuring between 90-150 cm long. In an embodiment,
distance D1 is in the range of 0.5-12 inches. Side exit port 158 is
sized to receive what is known in the art as a short wire, which is
so-named because it does not need to be the full length of a
guidewire used for advancing the guide catheter assembly to the
desired site. In an embodiment, such a short wire is a nominally
0.018 to 0.021 inch diameter guidewire. Thus, side exit port 158 in
such an embodiment is sized to receive a nominal 0.018 to 0.021
inch guidewire.
[0023] Dilator 150 may include features for removably coupling
dilator 150 to guide catheter 110. In the embodiment of FIG. 1,
dilator shaft 151 includes threads 162 at proximal end 154 which
mate with threads 122 on an inner surface of guide catheter 150.
Other ways to removably couple dilator 150 to guide catheter 110
may be used instead, such as, but not limited to a luer lock or
luer slip fitting, a radial protrusion on one component and a
mating indentation on the other component, or an external cap on
dilator end 154 that press-fits over guide catheter hub 120.
However, such features to removably couple dilator 150 to guide
catheter 110 need not be included.
[0024] FIG. 2 shows an optional feature that may be included as
part of guide catheter assembly 100. The reference numerals used in
FIG. 2 for features in common with FIG. 1 are the same as in FIG. 1
because the features are the same. FIG. 2 additionally shows an
obturator 170 disposed through dilator lumen 156. Obturator 170 may
also be called a deflector, a stylet or a stiffening stylet.
Obturator 170 is sized so as to be able to slidably fit within
dilator lumen 156. Obturator 170 includes a proximal end (not
shown) and a distal end 171. In the embodiment of FIG. 2, distal
end 171 includes an angled surface 172. With obturator 170 disposed
through dilator lumen 156 such that angled surface 172 is disposed
proximally adjacent to side exit port 158, angled surface 172
almost completely obstructs dilator lumen 156 and deflects a
guidewire towards side exit port 158 when such a guidewire is
inserted through distal opening 153 and advanced proximally towards
side exit port 158. Further, obturator 170 may stiffen guide
catheter assembly 100 to straighten a pre-formed curve in guide
catheter 110 and assist in advancing guide catheter assembly 100
through the vasculature. Obturator 170 may be made from materials
commonly used for obturators, dilators or stylets, such as, but not
limited to, polyethylene (PE), polypropylene (PP), fluorinated
ethylene propylene (FEP), or stainless steel.
[0025] FIG. 3 shows another optional feature that may be included
as part of guide catheter assembly 100. The reference numerals used
in FIG. 3 for features in common with FIG. 1 are the same as in
FIG. 1 because the features are the same. FIG. 3 additionally shows
a removable short wire tube 180 disposed through side exit port
158a, into dilator lumen 156, and extending to distal opening 153.
Side exit port 158a in FIG. 3 may be larger than side exit port 158
in FIGS. 1-2 to accommodate short wire tube 180. However, side exit
port 158 in FIGS. 1-2 may be the same size as side exit port 158a
if such as size is large enough to accommodate short wire tube 180
and a "short wire," as described in more detail below.
[0026] Removable short wire tube 180 includes a distal end 182, a
proximal end 184, and a tube lumen 186 extending from a distal
opening 183 at distal end 182 to a proximal opening 185 at proximal
end 184. When removable short wire tube 180 is in place as part of
catheter assembly 100, distal end 182 is adjacent distal end 152 of
dilator 150, proximal end 184 is disposed adjacent side exit port
158a, and removable short wire tube 180 extends through a distal
portion of dilator lumen 156 from distal opening 153 through side
exit port 158a. In use, as described in more detail below, a "short
wire" with a nominal diameter of 0.018-0.021 inch is inserted
through distal opening 183, and removable short wire tube 180
guides the short wire through tube lumen 186, out of side exit port
158a and proximal opening 185. After guide catheter assembly 100 is
advanced over the short wire, as described in more detail below,
the short wire is removed by pulling the short wire from where the
short wire exits proximal opening 185. Removable tube 180 can be
removed from dilator lumen 156 simultaneously with or after the
removal of the short wire by pulling on proximal end 184. A
guidewire with a larger diameter than the short wire can then be
advanced through dilator lumen 156 from proximal opening 154 to
distal opening 153. Removable short wire tube 180 assists in
guiding the short wire to side exit port 158a, and tube lumen 186
more closely matches the diameter of the short wire because tube
lumen 186 does not need to accommodate a larger guidewire, as does
dilator lumen 156.
[0027] Removable short wire tube 180 may be made from materials
commonly used in catheters, such as, but not limited to, any
suitable material, such as, but not limited to, polyimide,
polyethylene (PE), polyimide, fluorinated ethylene propylene (FEP),
polytetrafluoroethylene (PTFE) or polyethylene block amide
copolymer (PEBA), Short wire tube 180 may be made from
biocompatible metals such as stainless steel or superelastic NiTi
(nitinol) provided that sufficient flexibility is provided, as by a
pattern of openings in the tubular wall, or by making tube 180 from
a coiled wire. Combinations of the above polymeric and metallic
materials are also possible.
[0028] FIG. 4 shows a guide catheter assembly 200 according to
another embodiment hereof. Guide catheter assembly 200 includes a
guide catheter 210 and a dilator 250. Guide catheter 210 may be the
same as guide catheter 110 of FIGS. 1-3, including a guide shaft
211 and a hub 220. Dilator 250 includes a generally tubular dilator
shaft 251 including a distal end 252, a proximal end 254, and a
dilator lumen 256. Dilator lumen 256 extends only from a distal
opening 253 at distal end 252 to a side exit port 258. Thus, in
contrast to the embodiments of FIGS. 1-3, dilator lumen 256 extends
only through the portion of dilator 250 disposed distal of guide
catheter distal end 212, as explained in more detail below. Dilator
lumen 256 is sized such that a short wire may be disposed
therethrough. Thus, in an embodiment, dilator lumen 256 is sized to
receive a nominal 0.018 to 0.021 inch guidewire. Further, dilator
shaft 251 is sized such that an outer diameter of dilator shaft 251
fits within guide lumen 216.
[0029] Dilator 250 is longer than guide catheter 210 such that with
dilator 250 disposed through proximal opening 215 of guide catheter
210, dilator 250 is configured to protrude from distal opening 213
of guide catheter 210. As can be seen in FIG. 4, with proximal end
254 of dilator 250 generally aligned along an axis with proximal
end 214 of guide catheter 210, distal end 252 of dilator 250
extends distally beyond distal end 212 of guide catheter 212.
[0030] Further, with dilator 250 disposed through guide lumen 216
of guide catheter 210 and with proximal end 254 of dilator 250
generally aligned along an axis with proximal end 214 of guide
catheter 210, side exit port 258 is disposed between distal opening
253 of dilator 250 and distal opening 213 of guide catheter 210. As
explained above with regard to the embodiment of FIG. 1, a distance
D1 from distal opening 253 to side exit port 258 is sufficient such
that with distal end 252 disposed in a vessel of a patient's
vasculature, side exit port 258 remains outside of the patient's
body. In an embodiment, distance D1 is in the range of 0.5-12
inches. Side exit port 258 is sized to receive a short wire, as
will be explained in more detail below.
[0031] Dilator 250 may include features for removably coupling
dilator 250 to guide catheter 210. In the embodiment of FIG. 4,
dilator shaft 251 includes threads 262 at proximal end 254 which
mate with threads 222 on an inner surface of guide catheter 250.
Other ways to removably couple dilator 250 to guide catheter 210
may be used instead, as described above regarding the embodiment
shown in FIG. 1.
[0032] FIGS. 5-13 illustrate an embodiment of a method for
accessing the vasculature and advancing a guide catheter towards a
desired site using guide catheter assembly 100 or guide catheter
assembly 200 described above. FIGS. 5-13 show an embodiment of the
method using guide catheter assembly 100 of FIG. 1. Where
appropriate, differences in the method will be described with
respect to use of the additional components of FIGS. 2-3 or guide
catheter assembly 200 of FIG. 4.
[0033] In a first step, a needle 300 is used to gain access to a
vessel 310 of a patient's vasculature. Needle 300 is inserted
through tissue 312, through wall 314 of vessel 310, and into lumen
316 of vessel 310, as shown in FIG. 5. In some cases, a shallow
incision may first be made through the patient's skin into tissue
312. Vessel 310 can be any vessel to which a clinician wishes to
gain access such that guide catheter assembly 100 may be advanced
to a desired site. For example, and not by way of limitation,
vessel 310 may be an arterial blood vessel such as a femoral
artery, brachial artery, radial artery, or subclavian artery.
Needle 300 may be any needle used to access a vessel, as is known
in the art, but the size of needle 300 is selected to receive the
desired short wire. For example, and not by way of limitation,
needle 300 may be a 21 gauge angiographic needle, which size is
used with a 0.018 inch short wire in the modified Seldinger
percutaneous insertion technique.
[0034] With needle 300 having gained access to vessel 310, a short
wire 320 is inserted through an opening in a proximal end of needle
300, as shown in FIG. 5. Short wire 320 may be a nominally
0.018-0.021 inch diameter guidewire, as known in the art. As
described above, short wire 320 is referred to as a "short" wire as
it does not need to be the full length of a guidewire used for
advancing the guide catheter assembly to the desired site. Further,
short wire 320 is generally smaller in diameter than the full
length guidewire as short wire 320 is used with needle 300 and
dilator 150, and it is desirable for needle 300 to have a small
diameter as it is used during the first access to the vessel
310.
[0035] Short wire 320 is then advanced through a lumen 302 in
needle 300 and out of a distal opening 304 of needle 300, as shown
in FIG. 6. Thus, a distal end 322 of short wire 320 is disposed in
lumen 316 and a proximal end 324 of short wire 320 is disposed
outside of the patient and proximal to a proximal end of needle
300.
[0036] With short wire 320 disposed through needle 300 and into
vessel 310, needle 300 may be withdrawn from vessel 310 by pulling
needle 300 proximally over short wire 320, as indicated by the
arrow in FIG. 6. This leaves short wire 320 with distal end 322
disposed in vessel 310 and proximal end 324 disposed outside of the
body of the patient, as shown in FIG. 7.
[0037] Proximal end 324 of short wire 320 is then loaded into guide
catheter assembly 100, as shown in FIG. 8. Short wire 320 is loaded
into guide catheter assembly 100 by inserting proximal end 324 of
short wire 320 into distal opening 153 of dilator 150. If the guide
catheter assembly of the embodiment of FIG. 3 is used, proximal end
324 of short wire 320 is inserted into distal opening 183 of
removable short wire tube 180.
[0038] While short wire 320 is held in fixed position with respect
to the patient by the clinician gripping the wire near the puncture
site, guide catheter assembly 100 is advanced over the short wire
320 until short wire proximal end 324 exits through side exit port
158. To achieve this maneuver without losing control of short wire
320, the length of short wire 320 exposed from the patient must be
at least as long as distance D1 from distal opening 153 to side
exit port 158. E.g. see FIGS. 1 and 4. If obturator 170 of FIG. 2
is used, obturator 170 is positioned such that obturator distal end
171 is proximally adjacent to side exit port 158. Thus, as guide
catheter assembly 100 is advanced over short wire 320, short wire
proximal end 324 is deflected by angled surface 172 towards side
exit port 158. Once short wire proximal end 324 extends from side
port 158, the clinician may shift his/her grip on short wire 320
from near the puncture site to exposed short wire proximal end 324.
Guide catheter assembly 100 is then advanced over the short wire
320 until dilator distal end 152 is disposed in lumen 316 of vessel
310, as shown in FIG. 9.
[0039] Short wire 320 is then removed from the patient and guide
catheter assembly 100 by pulling on short wire proximal end 324. If
the removable short wire tube 180 of FIG. 3 is used, it is also
removed by pulling on proximal end 184 of removable short wire tube
180. This leaves guide catheter assembly 100 with distal end 152 of
dilator 150 disposed in lumen 316 and guide catheter 110 disposed
outside of the patient, as shown in FIG. 10. If the obturator 170
of FIG. 2 is used, it is also removed at this time.
[0040] A full-length angiography or procedural guidewire 340 is
then loaded into guide catheter assembly 100 by inserting a distal
end 342 of guidewire 340 into proximal opening 154 of dilator 150,
as shown by the arrow in FIG. 10. Guidewire 340 is typically a
nominal 0.035 or 0.038 inch diameter guidewire, as known to those
skilled in the art. However, other guidewires may be used if
appropriate for the particular procedure or access site. Guidewire
340 is advanced through guide catheter assembly 100 until distal
end 342 of guidewire 340 exits distal opening 153 of dilator 150
such that distal end 342 of guidewire 340 is disposed in lumen 316
of vessel 310, as shown in FIG. 11.
[0041] Guide catheter assembly 100 is then advanced over guidewire
340, as indicated by the arrow in FIG. 11 until distal end 112 of
guide catheter 110 is disposed in lumen 316, as shown in FIG. 12.
Dilator 150 may then be removed from guide catheter 110 by pulling
on proximal end 154 of dilator 150 such that dilator 150 slides
proximally through guide lumen 116, as indicated by the arrow in
FIG. 12. With dilator 150 removed from guide catheter 110 as shown
in FIG. 13, guide catheter 110 and guidewire 340 may be advanced to
the desired site in the vasculature, as is known in the art.
Optionally, guide catheter assembly 100 with dilator 150 disposed
through guide catheter 210 can be advanced to the desired site in
the vasculature using dilator 150 as a flexible leader. Thus,
dilator 150 may be removed from guide catheter 110 before or after
guide catheter assembly 100 reaches the desired site.
[0042] While the method described in FIGS. 5-13 has been described
with respect to guide catheter assembly 100, and the additional
features of FIGS. 2-3 have been described where appropriate, the
guide catheter assembly 200 of FIG. 4 may also be used. When using
the guide catheter assembly 200 of FIG. 4, the steps described with
respect to FIGS. 5-9 are identical to the method described using
guide catheter assembly 100. However, because dilator 250 of guide
catheter assembly 200 does not include a lumen proximal of side
exit port 258, guidewire 340 is not disposed through dilator 250 as
described with respect to FIGS. 10-13. Instead, guide catheter
assembly 200 is advanced with dilator 250 into lumen 316 of vessel
310. Then, using dilator 250 as a leader or acting as a guidewire,
guide catheter assembly 200 with dilator 250 disposed through guide
catheter 210 is advanced to the desired site in the vasculature.
When guide catheter 210 reaches the desired site, dilator 250 is
removed from within guide catheter 210. Alternatively, dilator 250
can be removed from guide catheter 210 and replaced with guidewire
340 before or after guide catheter assembly 200 reaches the desired
site.
[0043] While various embodiments according to the present invention
have been described above, it should be understood that they have
been presented by way of illustration and example only, and not
limitation. It will be apparent to persons skilled in the relevant
art that various changes in form and detail can be made therein
without departing from the spirit and scope of the invention. Thus,
the breadth and scope of the present invention should not be
limited by any of the above-described exemplary embodiments, but
should be defined only in accordance with the appended claims and
their equivalents. It will also be understood that each feature of
each embodiment discussed herein, and of each reference cited
herein, can be used in combination with the features of any other
embodiment.
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