U.S. patent application number 14/024064 was filed with the patent office on 2014-01-09 for method for accessing a renal artery.
This patent application is currently assigned to FISCHELL INNOVATIONS LLC. The applicant listed for this patent is FISCHELL INNOVATIONS LLC. Invention is credited to ROBERT E. FISCHELL.
Application Number | 20140012231 14/024064 |
Document ID | / |
Family ID | 49355167 |
Filed Date | 2014-01-09 |
United States Patent
Application |
20140012231 |
Kind Code |
A1 |
FISCHELL; ROBERT E. |
January 9, 2014 |
METHOD FOR ACCESSING A RENAL ARTERY
Abstract
An elongated hollow tube guiding catheter forming a portion of a
guiding catheter includes a proximal end, distal end, and distal
section. The distal section includes a curved section and a
straight section. The curved and straight sections are shaped for
facilitating introduction and retention of the catheter into the
ostium of a renal artery. The system includes a dilator inserted
into the catheter hollow tube with a curved distal section of the
dilator opposingly extending opposite the curved distal section of
the guiding catheter hollow tube. The guiding catheter includes a
side arm positioned near the guiding catheter's proximal end with a
multi-way stop cock fixedly attached onto a proximal end of the
side arm tube.
Inventors: |
FISCHELL; ROBERT E.;
(DAYTON, MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
FISCHELL INNOVATIONS LLC |
FAIR HAVEN |
NJ |
US |
|
|
Assignee: |
FISCHELL INNOVATIONS LLC
FAIR HAVEN
NJ
|
Family ID: |
49355167 |
Appl. No.: |
14/024064 |
Filed: |
September 11, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13488526 |
Jun 5, 2012 |
8562573 |
|
|
14024064 |
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Current U.S.
Class: |
604/509 |
Current CPC
Class: |
A61M 25/01 20130101;
A61M 39/223 20130101; A61M 25/0102 20130101; A61M 25/09 20130101;
A61M 2039/066 20130101; A61M 25/04 20130101; A61M 25/0041 20130101;
A61M 29/00 20130101; A61M 2039/229 20130101 |
Class at
Publication: |
604/509 |
International
Class: |
A61M 25/01 20060101
A61M025/01; A61M 25/09 20060101 A61M025/09 |
Claims
1. A method for placing a distal straight section at the end of a
distal curved section of a renal artery guiding catheter into and
through the ostium of a renal artery of a patient who is being
treated for high blood pressure, the method including the following
steps: a) placing a guide wire through the femoral artery and into
the aorta of the patient that is being treated for high blood
pressure; b) placing a dilator into a renal artery guiding catheter
so that a curved distal section of a hollow tube that is located at
a distal section of guiding catheter and a curved distal section of
the dilator oppose each other so that together the dilator and the
guiding catheter form a comparatively straight structure; c)
advancing the dilator and guiding catheter over the guide wire
until the distal end of the guiding catheter lies approximately
10.+-.5 cm beyond the ostium of a renal artery; d) removing the
dilator and guide wire from the interior lumen of the guiding
catheter hollow tube; and e) pulling the guiding catheter back down
the aorta until the straight section at the distal end of the
curved section of the guiding catheter is placed into and through
the ostium of a renal artery.
2. The method of claim 1 including the step of orienting a side arm
tube placed at the proximal end of the guiding catheter to be
approximately parallel to the table onto which the patient is lying
on his or her back which orientation causes the straight section at
the end of the curved distal section of the guiding catheter to
have the optimum azimuth angle around the aorta so as to allow for
ready passage of the distal straight section of the guiding
catheter to enter through the ostium of the renal artery.
Description
RELATED APPLICATIONS
[0001] This application is a Divisional patent application of
co-pending application Ser. No. 13/488,526, filed on 5 Jun. 2012,
now pending. The entire disclosure of the prior application, Ser.
No. 13/488,526, from which an oath or declaration is supplied, is
considered a part of the disclosure of the accompanying Divisional
application and is hereby incorporated by reference.
FIELD OF USE
[0002] This invention is in the field of methods and devices for
accessing the renal arteries for the treatment of high blood
pressure.
BACKGROUND OF THE INVENTION
[0003] There are now several catheters being developed by several
different companies whose goal is to perform renal nerve
denervation to reduce the blood pressure for hypertensive patients.
Therefore, it will become increasingly important over the next
several years to create improved means for renal denervation
catheters to access the renal arteries.
[0004] The current practice for accessing the renal arteries is to
first use an arterial access needle puncture at the groin, and then
a guide wire is placed through that needle into the femoral artery.
The needle is then removed while the guide wire remains in place in
the femoral artery at the groin. An introducer sheath with dilator
would then be advanced over the guide wire and into the lumen of
the femoral artery. The dilator and the guide wire would then be
removed and a guiding catheter would be advanced through the
introducer sheath until its distal end would be placed into a renal
artery. A catheter for renal denervation could then be advanced
through the guiding catheter and it would be used to kill a section
of the renal nerves that surround the renal artery thus permanently
lowering the blood pressure of a patient that is hypertensive.
[0005] The renal denervation catheters require a fairly large
diameter guiding catheter; typically 6, 7 or 8 French size. Since
the outer diameter of the sheath through which the guiding catheter
is inserted is typically 2 to 3 French sizes larger than the outer
diameter of the guiding catheter, a fairly large diameter hole must
be made through the wall of the femoral artery. These larger size
holes can lead to excessive bleeding at the groin after the guiding
catheter and the sheath are removed.
[0006] At this time, all guiding catheters designed for accessing
the renal arteries terminate at their proximal end with a Luer
fitting. To perform an intra-arterial procedure with any existing
guiding catheter, it is necessary to attach a Tuohy-Borst "Y"
adaptor onto the Luer fitting at the guiding catheter's proximal
end. The introducer sheath and Tuohy-Borst "Y" adaptor are each
components that require additional time for the interventional
cardiologist to properly place, and they add to the cost of
performing intra-arterial procedures. Also, the introducer sheath
through which the guiding catheter is inserted typically must have
a three-way stopcock attached to a Luer fitting on a side arm tube
that is located near the proximal end of the introducer sheath. The
additions of a Tuohy-Borst "Y" adaptor to the guiding catheter and
adding a three-way stopcock to the side tube of the introducer
sheath adds additional cost and time to any procedure for accessing
the renal artery. If a means for accessing the renal artery could
be accomplished without requiring an introducer sheath and without
requiring the additional parts of a Tuohy-Borst "Y" adaptor and a
three-way stopcock, the procedure could be done in less time and at
a lower cost.
[0007] In U.S. Pat. No. 5,389,090, Fischell et al describe an
improved guiding catheter that is particularly useful for accessing
the coronary arteries. However, there are no specific features of
that invention that are specifically devoted for improved access
for the renal arteries. Specifically, the invention described in
the '090 patent does not teach markings on the shaft of the guiding
catheter to assist in the placement of that guiding catheter into
the renal arteries. The '090 patent also fails to teach the
importance of a side arm tube that lies in the same plane as does
the curve at the distal section of the guiding catheter, which
feature enables the operator to have the correct azimuth angle for
placement of the distal end of the guiding catheter into and
through the ostium of the renal artery. Still further, the '090
patent fails to teach a three-way stopcock formed integral with the
side arm tube at the guiding catheter's proximal end that precludes
the need for the operator to open a separate package to attach that
device to the guiding catheter. A guiding catheter design that
would not require the use of an introducer sheath and would have a
Tuohy-Borst fitting and a three-way stopcock each formed integral
with the guiding catheter at its proximal end would result in
savings of both time and cost for the procedure to access the renal
arteries.
SUMMARY OF THE INVENTION
[0008] The present invention is an improved guiding catheter
designed explicitly to access the renal artery. This renal artery
guiding catheter eliminates the need for: 1) an introducer sheath;
2) a separate Tuohy-Borst "Y" adaptor; and 3) a separate three-way
stopcock. By this means, the present invention provides a means and
method for reducing the time and expense for performing renal
artery procedures. Furthermore, the guiding catheter with
straightening dilator as described herein allows the hole in the
wall of the femoral artery to be approximately 2 to 3 French sizes
smaller in diameter as compared to the hole that would be created
if an introducer sheath is also used, thus decreasing the
possibility of bleeding at the groin. Still further by making the
curve at the distal section of the shaft of the guiding catheter to
be coplanar with the guiding catheter's side arm tube, the
interventional cardiologist can more easily place the distal end of
the guiding catheter into and through the ostium of the renal
artery. Additionally, explicit markings along the tube of the
guiding catheter allow the interventional cardiologist to more
accurately place the distal end of the guiding catheter into the
aorta prior to removing the dilator and guide wire from the guiding
catheter. Still further, the shape of the distal section of this
special guiding catheter allows entry of a straight section at the
distal end of the guiding catheter to be advantageously placed into
the renal artery irrespective of the angle that the renal artery
makes with the aorta.
[0009] The advantages of the present invention are accomplished by
utilizing a dilator that has a curved distal section placed 180
degrees opposite from the curve at the guiding catheter's distal
section, which opposing curve of the dilator is used to initially
straighten the curved distal section of the renal artery guiding
catheter as it is advanced through the patient's arterial system.
In this way, the dilator straightens the guiding catheter so that
it can be used like an introducer sheath to enter the femoral
artery by being advanced over a previously placed guide wire. Once
the distal ends of the guide wire, dilator and guiding catheter are
placed just beyond the ostium of a renal artery, the dilator and
guide wire are withdrawn which allows a distal section of the
guiding catheter to assume its normally bent shape. By pulling the
guiding catheter back down the aorta, the cardiologist can then
place the guiding catheter's distal end into and through the ostium
of either the right or the left renal artery. Any one of several
well-known procedures can then be performed including denervation
of the renal nerves, angiography, balloon angioplasty, and
atherectomy or stent placement. The unique design of the distal
section of the guiding catheter allows a short straight section at
that curves distal end to be placed into the renal artery
irrespective of the angle that the renal artery makes with the
aorta. This design feature precludes the need for making a variety
of shapes for different guiding catheters that would otherwise be
required to access renal arteries that make different entry angles
relative to the aorta. Another means for expressing this advantage
is that only one product code is required to be manufactured by the
company that makes this product, which product will include a
guiding catheter having a distal straight section that is able to
readily enter a renal artery irrespective of the angle that that
renal artery makes with the aorta. A marketing advantage for the
present invention is that the manager of a cath lab will prefer to
have a reduced inventory of guiding catheters to access the femoral
artery. Therefore, having only a single product code would provide
that desired goal of a reduced inventory for this renal artery
guiding catheter product.
[0010] The guiding catheter of the present invention utilizes a
Tuohy-Borst fitting that is formed integral with the guiding
catheter and a side arm tube all placed at the guiding catheter's
proximal end. This capability obviates the need for attaching a
separate Tuohy-Borst "Y" adaptor at the guiding catheter's proximal
end to accomplish arterial access with minimum bleeding. The
guiding catheter's Tuohy-Borst fitting could be tightened around
guide wires or the shaft of catheters that are advanced through the
guiding catheter.
[0011] The side arm tube, also located at the proximal end of the
guiding catheter. could terminate in a female Luer fitting as
described in the '090 patent, or more advantageously it could have
a three-way stopcock formed integral with the side arm tube at the
tube's proximal end. That three-way stopcock could be attached to a
manifold for the introduction of saline solution, contrast medium,
medications or a solution such as alcohol, which liquids can be
used in the procedure for renal denervation. Thus, the Tuohy-Borst
fitting with side arm at the guiding catheter's proximal end
eliminates the need for a separate Tuohy-Borst "Y" adaptor and the
three-way stopcock formed integral at the proximal end of the side
arm tube eliminates the need to have that device separately
attached to a Luer fitting at the proximal end of the side arm
tube. Still further, the direction of the side arm tube relative to
the guiding catheter tube being the same as the direction of the
curved distal section of the guiding catheter allows the
interventional cardiologist to easily find the correct azimuth
angle around the circumference of the aorta for the easy placement
of the distal end of the guiding catheter through the ostium of the
renal artery.
[0012] Another novel feature of the present invention are markings
on the outer cylindrical surface of the elongated hollow tube that
constitutes most of the length of the guiding catheter. These
markings are set at the distance to advance the guiding catheter
through the patient's arterial system so that the distal end of the
guiding catheter will be situated approximately 10.+-.5 cm beyond
the ostia of the renal arteries depending on the height of that
patient. This can be accomplished because the distance from the
skin at the groin entry site for the guiding catheter to the point
at a 10.+-.5 cm distance beyond the ostium of either renal artery
is highly dependent upon how tall a particular patient would
be.
[0013] Thus, it is an objective of the present invention to allow
placement of a renal artery guiding catheter to have its distal end
placed into the renal artery without requiring insertion of the
guiding catheter through an introducer sheath thus allowing a
smaller hole to be made in the wall of the femoral artery.
[0014] Another objective of this invention is to eliminate the need
for a separate Tuohy-Borst "Y" adaptor by having a Tuohy-Borst
fitting formed integral with the guiding catheter at the guiding
catheter's proximal end.
[0015] Still another objective of the present invention is to have
a side arm tube that has a three-way stopcock formed integral at
the proximal end of that side arm tube thus eliminating the need
for a separately attached three-way stopcock.
[0016] Still another objective of the present invention is to have
a side arm tube that extends outward from the shaft of the guiding
catheter so as to be co-planar with plane of the guiding catheter's
curved distal section and also to be extending in the same
direction as that curved distal section of the guiding catheter
thus assisting the interventional cardiologist in placing the
distal end of the guiding catheter into and through the ostium of a
renal artery.
[0017] Still another objective of the invention is to use a guide
wire and a dilator within a guiding catheter for placement of the
guiding catheter without requiring an introducer sheath.
[0018] Still another objective of the invention is to utilize a
dilator having a curved distal section that when placed inside a
guiding catheter that has a curved dilator section in the opposite
direction causes the dilator-guiding catheter assembly to be
essentially straight for easy insertion through the arterial
system.
[0019] Still another objective of the invention is to reduce the
cost and time required for performing arterial interventional
procedures for accessing the renal arteries by eliminating the need
for an introducer sheath and by having a Tuohy-Borst fitting and a
three-way stopcock each formed integral with the guiding catheter
at its proximal end.
[0020] Still another objective of the invention is to reduce the
probability of bleeding at the skin where the guiding catheter
enters the femoral artery by eliminating the need for an introducer
sheath to have the guiding catheter gain access to the patient's
arterial system.
[0021] These and other objects and advantages of this invention
will become obvious to a person of ordinary skill in this art upon
reading of the detailed description of this invention including the
associated drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a side view of a guiding catheter system including
a guide wire, straightening dilator and a guiding catheter with
Tuohy-Borst fitting and a three-way stopcock mounted onto the side
arm tube of the guiding catheter.
[0023] FIG. 2 is a side view of the guiding catheter showing its
curved distal section that occurs when the oppositely curved
dilator is withdrawn.
[0024] FIG. 3 is a side view of a straightening dilator
illustrating its curved distal section that curves opposite in its
direction compared to the curved distal section of the guiding
catheter into which the dilator is inserted so that the combination
of both curves, as seen in FIG. 1, provides a comparatively
straight distal section of the combined guiding catheter and
straightening dilator for improved insertion through the patient's
arterial system.
[0025] FIG. 4 is an enlarged partial longitudinal cross section of
the proximal end of the guiding catheter at section 4-4 of FIG.
2.
[0026] FIG. 5 is an enlarged transverse cross section of the
Tuohy-Borst fitting at section 5-5 of FIG. 1.
[0027] FIG. 6A is a cross section of a Tuohy-Borst gland with a
half "O" ring with the gland in a fully open position.
[0028] FIG. 6B is a cross section of a Tuohy-Borst gland with a
half "O" ring with the gland in a fully closed position.
[0029] FIG. 7 illustrates the initial position of the distal ends
of the guide wire, dilator and guiding catheter as they are
initially inserted into the aorta just beyond the ostia of the left
and right renal arteries.
[0030] FIG. 8 shows the initial position of the distal section of
the guiding catheter within the aorta immediately after the guide
wire and dilator have been withdrawn.
[0031] FIG. 9 shows the distal end of the guiding catheter placed
into the renal artery after it has been pulled back from the
position shown in FIG. 8.
DETAILED DESCRIPTION OF THE INVENTION
[0032] FIGS. 1, 2 and 3 illustrate the guiding catheter system 10
having a guiding catheter 12 with an elongated tube 11 with a
distal section 11A having a distal end 19E, a Tuohy-Borst fitting
20, a side arm tube 14 with a three-way stopcock 30 at its proximal
end, and a guide wire 15 and a straightening dilator 16 each
situated within the tube 11. It should be noted that the
configuration of FIG. 1 is how this guiding catheter system 10
would be placed through the patient's skin at the groin, then into
the femoral artery and then advanced through the aorta and beyond
the renal arteries as shown in FIG. 7.
[0033] As best seen in FIG. 2, the guiding catheter 12 has an
elongated cylindrical tube 11 with a curved distal section 11A
ending at point 19D where a short straight section 19S begins. The
straight section 19S extends to its distal end 19E. It should be
noted that the angle "a" that the centerline of the straight
section 19S makes with the centerline of the straight section of
the tube 11 should optimally be about 30 degrees. This angle "a"
makes it possible for the straight section 19S to have a straight
entry into a renal artery even if that renal artery makes a
downward angle of as little as 30 degrees relative to the aorta.
This is shown in greater detail with the assistance of FIG. 9.
[0034] The tube 11 also has markings 11B, 11C, 11D, 11E, 11F and
11G that indicate points on the tube 11 corresponding to how far
the interventional cardiologist should advance the system 10 into
the patient's arterial system depending on the height of the
patient. The single line mark 11C indicates the extent to which the
tube 11 should be advanced if the patient is approximately 5 feet
tall. The number "5" (which is element 11B) reminds the
cardiologist that the mark 11C corresponds to the point on the
patient's skin at the groin to which the tube 11 should be advanced
if the patient is approximately five feet tall. If the patient is 6
feet tall, as indicated by the "6" of element 11E, then the three
lines of element 11F indicate the point to which the tube 11 should
be advanced to place the mark 11F at the skin of the patient at
his/her groin if that patient is six feet tall. The marks 11D and
11G correspond respectively to patient heights of five feet, six
inches and six feet, six inches. For patient heights corresponding
to a position between these markers, the cardiologist can set the
depth to which the tube 11 is inserted through the patient's skin
to be between the appropriate markers. For example, for a woman
whose height is five feet, three inches, the tube 11 would be
advanced through the patient's skin at her groin with the tube 11
placed at her skin halfway between the one line of mark 11C and the
two lines of mark 11D. The approximate distance between each
adjacent pair of the marks 11C, 11D, 11F and 11G would be 5.+-.2
cm.
[0035] FIG. 2 also shows a proximal section of the guiding catheter
12 that has a threaded base 21, a threaded nut 22 and a side arm
tube 14 that has a three-way stopcock 30 at its proximal end. When
the marker 27 on the threaded base 21 is aligned with the marker 28
on the threaded nut 22, then the curved distal sections of the tube
11 and the dilator 16 will be 180 degrees in opposite directions
and the distal curved sections 11A and 16A will act together to
create a generally straight guiding catheter system 10 as shown in
FIG. 1. This function will be described in greater detail with the
assistance of FIGS. 3, 4 and 5 below.
[0036] As shown in FIG. 3, the dilator 16 has a distal curved
section 16A that is connected to the straight section 16S at the
point 16D, and the straight section 16S terminates at a tapered
distal end 16E. The dilator tube 16 is designed to fit snugly
around the guide wire 15. The dilator tube 16 is designed to be
advanced over the guide wire 15 and within the lumen 13 of the
guiding catheter tube 11 so that the assembly of the guiding
catheter system 10 (as shown in FIG. 1) can be in a straightened
condition so that it can be readily advanced through the patient's
arterial system. All the sections of the dilator tube 16 are
designed to fit slideably within the interior lumen 13 of the
guiding catheter tube 11. It should be understood that there could
be only one bend, or two or more bends at this distal section of
the dilator tube 16 and the curved section 11A of the tube 11. The
dilator also has at its proximal end a handle 17 with a cone 17A
having a key 17B for mating with the keyway 26 of the threaded nut
22 of the Tuohy-Borst fitting 20 as seen in FIGS. 4 and 5.
[0037] As seen in FIGS. 1, 2 and 4, the guiding catheter 12 has a
Tuohy-Borst fitting 20 that is integrally attached as a one-piece
construction at the proximal end of the catheter tube 11. As best
seen in FIG. 4, the Tuohy-Borst fitting 20 has a threaded base 21,
a side arm 14 having a three-way stopcock 30 at its proximal end, a
threaded nut 22 with conical entry lumen 23, a soft elastomer gland
24 and a comparatively hard washer 25. As seen in FIG. 4, when the
nut 22 is not tightened down, the gland 24 is not compressed and
the lumen 23 is in fluid communication with the lumen 13 of the
elongated tube 11 and the lumen 18 of the side arm tube 14. When
the nut 22 is screwed into the threaded base 21, the washer 25
compresses the soft elastomer gland 24 which can then fit snugly
around a guide wire 15 or a dilator 16 or the shaft of a renal
artery denervation catheter or a stent delivery catheter.
Furthermore, when the nut 22 is fully screwed onto the threaded
base 21, the central lumen of the gland 24 can be totally closed so
that no blood will leak out of the guiding catheter's proximal end
even if there is no guide wire 15 or catheter tube 11 placed
through that gland 24.
[0038] As shown in FIGS. 1 and 2, the threaded base 21 has an
indicator mark 27 which, when aligned with an indicator mark 28 on
the nut 22, informs the operator that the tube 11 and the dilator
16 are positioned so that together they form a straight distal end
section as shown in FIG. 1. It is also conceived that a straight
dilator with a comparatively stiff distal section 16A could be used
to straighten out the curved end section 11A of the guiding
catheter 12 as is shown in FIG. 1. The stiffer the distal section
of such a dilator 16, the straighter would be the distal section of
the assembly of the dilator 16 with the guiding catheter 12. Of
course, when such a straight (or curved) dilator would be pulled
out, the distal section 11A of the guiding catheter 12 would assume
its proper shape as generally illustrated in FIG. 2.
[0039] FIG. 4 shows the three-way stopcock 30 fixedly attached to
the side arm tube 14 by means of the connecting tube 31.
Specifically, FIG. 4 shows the stopcock 30 with an operating lever
34 in an intermediary position. For an external fluid source to
connect to the lumen 18 by means of the Luer fitting 33, the lever
34 would be placed over the Luer fitting 32. For a fluid source to
deliver fluid into the lumen 18 via the Luer fitting 32, the lever
34 would be placed over the Luer fitting 33. To close the side arm
tube 14 from any access through either Luer fitting 32 or 33, the
lever 34 would be placed over the connecting tube 31. It should be
understood that a two-way or a four-way stopcock could be used
instead of the three-way stopcock 30 shown in FIGS. 1 and 4. In
general, a multi-way stopcock could be advantageously formed
integral at the proximal end of the side arm tube 14.
[0040] FIGS. 4 and 5 also show a keyway 26 in the nut 22 which is
adapted to mate with the key 17B of the dilator handle 17. When the
marks 27 and 28 are aligned as shown in FIGS. 1 and 2, the
alignment formed by keyway 26 and the key 17B guarantees that the
bends in the distal sections of the guiding catheter tube 11 and
the dilator 16 oppose each other so as to straighten the guiding
catheter system 10 as shown in FIGS. 1 and 7. In this position, the
guiding catheter 12 with dilator 16 in place can be readily
advanced over the guide wire 15 until the distal end 19E of the
guiding catheter tube 11 is located just beyond the ostium of the
renal artery to which access is desired as is shown in FIG. 7. The
dilator 16 and guide wire 15 can then be withdrawn and the guiding
catheter 12 will assume its desired distal section shapes as shown
in FIGS. 8 and 9. The cardiologist can then place the guiding
catheter's distal end 19E through the ostium of a renal artery as
shown in FIG. 9.
[0041] It is important to note that the guiding catheter system 10
should not be stored or packaged in the configuration as shown in
FIG. 1. If that were to be done, then in time, and particularly if
there is any exposure to an elevated temperature, the final distal
section curve of the catheter tube 11 could be reduced and that
would not be the optimum curve which is most suitable for accessing
the renal arteries. If the package containing the system 10 was
sold as shown in FIG. 1, then the final curvature at the distal
section of the tube 11 could be considerably reduced as compared to
the curve shown in FIG. 2. Therefore, the present invention
conceives of the fact that the elements of the guiding catheter
system 10 should be separated into a kit that at least allows the
guiding catheter tube 11 and the dilator tube 16 to remain apart
until the guiding catheter system 10 is assembled prior to
insertion of the guiding catheter system 10 into the patient's
arterial system.
[0042] FIGS. 6A and 6B illustrate an alternative design for the
soft elastomer gland of a Tuohy-Borst fitting 20. Specifically,
FIG. 6A shows a gland 70 in its open (not compressed) state. The
gland 70 has a generally cylindrical interior surface 71A on which
is placed a half "O" ring 72A. When the nut 22 of FIG. 4 is
tightened, the gland 70 can be deformed to the shape shown in FIG.
6B wherein a highly curved interior surface 71B is formed with the
half "O" ring 72B being distorted to a closed or nearly closed
position as shown in FIG. 6B.
[0043] FIGS. 7, 8 and 9 illustrate how the present invention would
be used to effectively access either one or both of the renal
arteries 82 and 83. FIG. 7 is a posterior view of certain body
parts showing the aorta 80, the left kidney 81, the left renal
artery 82, the right renal artery 83, the right kidney 84 and also
the guiding catheter tube 11 in its straightened condition due to
the insertion of the dilator 16 which was previously advanced with
the guiding catheter 12 over the guide wire 15. It should be noted
that the right renal artery 83 is typically longer than the left
renal artery 82 due to the placement of the inferior vena cava
between the aorta 80 and the right kidney 83. The distal end 19E of
the guiding catheter tube 11 is shown in a position that is a
length "D" beyond the centerline of the ostia of the left and right
renal arteries. An optimum distance for this distance D would be
10.+-.5 cm. Thus, even if a patient of a particular height had his
or her renal artery centerline further away from the entry of the
guiding catheter system 10 at the patient's groin than that which
is indicated by the marks 11B to 11H on the tube 11 (as shown in
FIGS. 1 and 2) the distal end 19E of the tube 11 would still lie
distinctly above the renal artery centerlines. It should be noted
that the total length of the renal artery catheter 12 could
optimally be approximately 60 cm. The distance from the catheter's
distal end 19E to the first mark 11C (of FIGS. 1 and 2) being about
35.+-.5 cm and the length from the distal end 19E to the mark 11G
being approximately 50.+-.5 cm. It should be noted that the mark
11C corresponds to a patient height of five feet and the mark 11G
corresponds to a patient height of six feet, six inches. These
lengths have been chosen so that at least a length of approximately
10 cm will typically be situated outside of the patient's skin at
the groin irrespective of the patient's height. This 10 cm length
provides the interventional cardiologist with additional margin for
an extremely rare case when the renal arteries are even further
away from the femoral artery entry point of the guiding catheter
system 10 at the skin near the patient's groin.
[0044] After the guide wire 15 and the dilator 16 are withdrawn
from the guiding catheter tube 11, the curved distal section 11A of
the tube 11 would be situated as shown in FIG. 8. In this position,
the distal end 19E of the curved distal section 11A of the catheter
tube 11 would move against the wall of the aorta 80 opposite the
wall where the tube 11 is situated. When that condition has been
obtained, the cardiologist would typically inject contrast medium
(not shown) through the three-way stopcock 30 to visualize the
geometry of the ostium of the right renal artery 83. After that is
accomplished, the cardiologist would pull back the proximal end of
the guiding catheter 12 until the straight section 19S at the
distal end of the curved distal section 11A enters into and through
the ostium of the right renal artery 84 as shown in FIG. 9. It
should be understood that the distal section 11A of the tube 11
would be made radiopaque so that it can be readily visualized by
the interventional cardiologist using conventional image
intensified fluoroscopy.
[0045] A unique feature of the present invention is that the
interventional cardiologist could always get the straight section
19S to be aimed directly into the lumen of the renal artery
irrespective of the angle that the renal artery typically makes
with the aorta 80. This is certainly true for all angles "a" of the
axis of a renal artery relative to the axis of the aorta (as shown
in FIGS. 8 and 9) as normally found in human subjects.
Particularly, any angle "a" between 90 degrees and 30 degrees
downward could be readily accessed because of the shapes of the
curved distal section 11A and the straight distal section 11S of
the guiding catheter tube 11. The reason why this is the case is
because, as the cardiologist pulls the guiding catheter tube 11 in
a downward direction, the distal end 19E of the tube 11 will snap
into and through the ostium of the renal artery into which it is
aimed by means of the orientation of the side arm tube 14 at the
proximal end of the guiding catheter 12. This is true because the
straight section 19S will engage the point "p" (which is the apex
of the angle "a") as the guiding catheter tube 11 is pulled
downward through the aorta 80. The cardiologist can then adjust the
position of the proximal end of the guiding catheter 12 so that the
straight section 19S is aimed essentially straight into the right
renal artery 83 as shown in FIG. 9. It is obvious that this
technique can also be used to access either the right or the left
renal artery.
[0046] The orientation of the side arm tube 14 that remains outside
the patient's body will indicate to the cardiologist the correct
angular orientation (i.e., the azimuth) of the curved distal
section 11A and the straight section 19S at the distal portion of
the guiding catheter tube 11. This is achievable because when the
side arm tube 14 lies horizontally relative to the table on which
the patient has been placed on his or her back, then the straight
distal section 19S of the tube 11 will have the correct azimuth
angle around the interior lumen of the aorta 80 in order to enter
the correct renal artery. Thus when the side arm tube 14 would lie
in a direction to the right and parallel to the operating table,
then the distal end 19E of the tube 11 would enter the left renal
artery 82. Likewise, if the side arm tube 14 is lying to the left
and is parallel to the operating table, then the azimuth angle of
the distal end 19E of the guiding catheter tube 11 will be correct
for entering the right renal artery 83 as shown in FIG. 9.
[0047] This invention envisions that the Tuohy-Borst gland (such as
glands 24 or 70) could be fabricated from a soft elastomer such as
a low durometer silicone rubber. Furthermore, powdered Teflon or
powdered graphite could be incorporated into the soft elastomer to
improve its lubricity.
[0048] Thus the objectives of using a guiding catheter without
passing it through an introducer sheath and the elimination of the
need for a separate Tuohy-Borst "Y" adaptor and a separately
attached three-way stopcock have been shown. Furthermore, the
objective of inserting a guiding catheter and dilator over a guide
wire without the free release of blood through the guiding
catheter's proximal end can be accomplished by compressing the
gland 24 around the guiding catheter tube 11 as the guiding
catheter system 10 is advanced through the arterial system.
[0049] Although the discussion herein has been principally
concerned with renal guiding catheter systems, the present
invention is well suited for the placement of guiding catheters
into the ostium of other arteries such as the carotid and coronary
arteries as well as coronary artery bypass grafts.
[0050] Various other modifications, adaptations, and alternative
designs are, of course, possible in light of the above teachings.
Therefore, it should be understood at this time that within the
scope of the appended claims, the invention may be practiced
otherwise then as specifically described herein.
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