U.S. patent application number 10/773925 was filed with the patent office on 2004-09-30 for angioplasty method and means for performing angioplasty.
This patent application is currently assigned to Pierpont Family Limited Partnership. Invention is credited to Coyle, James A., Pierpont, Brien E..
Application Number | 20040193107 10/773925 |
Document ID | / |
Family ID | 32655756 |
Filed Date | 2004-09-30 |
United States Patent
Application |
20040193107 |
Kind Code |
A1 |
Pierpont, Brien E. ; et
al. |
September 30, 2004 |
Angioplasty method and means for performing angioplasty
Abstract
An angioplasty catheter assembly having an anchoring catheter
within a guide catheter such that the anchoring catheter anchors to
the guide catheter and the inner wall of a coronary artery; the
anchoring catheter has an opening in its tubular wall such that a
guide wire and balloon dilatation catheter can be disposed
therethrough and extending through the length of the anchoring
catheter.
Inventors: |
Pierpont, Brien E.; (St.
Petersburg, FL) ; Coyle, James A.; (Somerville,
MA) |
Correspondence
Address: |
ZARLEY LAW FIRM P.L.C.
CAPITAL SQUARE
400 LOCUST, SUITE 200
DES MOINES
IA
50309-2350
US
|
Assignee: |
Pierpont Family Limited
Partnership
St. Petersburg
FL
Medtronic Vascular, Inc.
Santa Rosa
CA
|
Family ID: |
32655756 |
Appl. No.: |
10/773925 |
Filed: |
February 6, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60446001 |
Feb 7, 2003 |
|
|
|
Current U.S.
Class: |
604/103.03 |
Current CPC
Class: |
A61M 25/104 20130101;
A61M 29/02 20130101; A61M 2025/018 20130101; A61M 2025/107
20130101; A61M 25/1011 20130101; A61M 2025/0183 20130101 |
Class at
Publication: |
604/103.03 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A catheter assembly, comprising, an elongated hollow anchoring
catheter having a distal end, and a tubular wall with inner and
outer surfaces, a hollow guiding catheter having a distal end and a
proximal end housing said anchoring catheter, a first anchoring
balloon member attached to the outer surface of said tubular wall
of the anchoring catheter and adapted upon inflation to project
outwardly from said tubular wall to engage the guiding catheter and
secure said anchoring catheter within said guiding catheter, an
elongated treatment catheter extending through an opening in said
tubular wall of said anchoring catheter and having a distal end,
and a guide wire extending through the treatment catheter and along
which the treatment catheter is slidable.
2. The assembly of claim 1 wherein the opening in the tubular wall
of the anchoring catheter is a slit extending between the distal
end and the proximal end housing of the anchoring catheter.
3. The assembly of claim 2 wherein a guide member is slidably
mounted on the anchoring catheter and facilitates the insertion of
the balloon dilatation catheter through the slit.
4. The assembly of claim 2 wherein the slit has a means for
releasably sealing the slit.
5. The assembly of claim 1 further comprising a second anchoring
balloon member attached to the inner surface of said tubular wall
and adapted upon inflation to project inwardly from said tubular
wall of the anchoring catheter to engage and retain the treatment
catheter against movement with respect to said anchoring
catheter.
6. The assembly of claim 5 further comprising a means associated
with the catheter assembly for independently inflating and
deflating the first and second anchoring balloon members.
7. The assembly of claim 1 further comprising a third anchoring
balloon member attached to the outer surface of the tubular wall of
the anchoring catheter and adapted upon inflation to project
outwardly to engage the blood vessel and secure the anchoring
catheter to the blood vessel, and whereby upon inflation of the
first and third balloon members the guiding catheter is operatively
secured to the blood vessel.
8. The assembly of claim 7 wherein blood by-pass means are located
in said tubular wall on opposite sides of at least one of said
first or third anchoring balloon members.
9. A catheter assembly, comprising: a hollow anchoring catheter
extendible through a guiding catheter; a treatment catheter
extendible through an opening in the tubular wall of the anchoring
catheter; and an external balloon attached to the anchoring
catheter and adapted to expand radially outwardly upon inflation to
engage the blood vessel wall and fix the anchoring catheter against
movement relative to the blood vessel.
10. The catheter assembly of claim 10 further comprising an
internal balloon attached to the anchoring catheter adapted to
expand radially inwardly upon inflation to engage the treatment
catheter and fix the anchoring catheter against movement relative
to the dilatation catheter.
11. The assembly of claim 9 wherein the opening in the tubular wall
of the anchoring catheter is a slit extending between the distal
end and the proximal end housing of the anchoring catheter.
12. The assembly of claim 11 wherein a guide member is slidably
mounted on the anchoring catheter and facilitates the insertion of
the balloon dilatation catheter through the slit.
13. The assembly of claim 11 wherein the slit has a means for
releasably sealing the slit.
14. A method for performing angioplasty, comprising: inserting a
guide wire through a treatment catheter to form a treatment
catheter assembly; inserting the treatment catheter assembly
through an opening in a tubular wall of an anchoring catheter to
form a unit; inserting a guiding catheter into a patient such that
the distal end of the guiding catheter is inserted into the origin
of the patient's artery; inserting the unit through the guiding
catheter; extending the anchoring catheter partially out of the
guiding catheter and into the blood vessel; inflating an external
balloon attached to the anchoring catheter to secure the anchoring
catheter to the within the blood vessel; sliding the treatment
catheter through the opening in the tubular wall of the anchoring
catheter and along the guide wire until a treatment element
disposed on the treatment catheter is adjacent a plaque area of the
blood vessel; actuating the treatment element to treat the plaque
area of the blood vessel.
15. The method of claim 14 further comprising deflating the
external balloon and withdrawing the treatment catheter, guide
wire, anchoring catheter and guiding catheter from the patient.
16. The method of claim 14 wherein the opening in the tubular wall
of the anchoring catheter is a slit extending between the distal
end and proximal end housing of the anchoring catheter.
17. The method of claim 16 wherein a guide member is slidably
mounted on the anchoring catheter and facilitates the insertion of
the treatment catheter through the slit.
18. The method of claim 16 wherein the slit has a means for
releaseably sealing the slit.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/446,001, filed Feb. 7, 2003.
BACKGROUND OF THE INVENTION
[0002] Cardiac catheterization and angioplasty are common medical
procedures. U.S. Pat. No. 5,484,412 describes an angioplasty
procedure wherein a balloon dilatation catheter is movably
positioned within an anchoring catheter, which in turn is located
within a guiding catheter. Optionally, internal balloons in the
anchoring catheter can be inflated to anchor it to the balloon
dilatation catheter. External balloons on the anchoring catheter
can be inflated to anchor it to the inside of the guiding catheter.
The balloons can be selectively inflated and deflated. Other
external balloons on the distal outer surface of the anchoring
catheter can be inflated to secure the anchoring catheter within
the blood vessel beyond the distal end of the guiding catheter.
Optional perforations in the wall of the anchoring catheter permit
blood to enter and exit, especially while external balloons are
inflated.
[0003] Using the anchoring catheter during an angioplasty
procedure, the conventional guiding catheter is first inserted into
the blood vessel to a location proximal to the narrowing targeted
for treatment. The conventional guidewire, balloon dilatation
catheter, and anchoring catheter are then inserted through the
guiding catheter with the anchoring catheter and balloon dilatation
catheter optionally being secured together by the internal balloons
on the anchoring catheter. When the guidewire, dilatation catheter
and anchoring catheter exit the distal end of the guiding catheter,
the internal balloons are collapsed, if they were inflated, and the
spaced external balloons are inflated to secure the anchoring
catheter to both the guiding catheter and the interior of the blood
vessel. The balloon dilatation catheter is then extended through
the end of the anchoring catheter to perform its conventional
function with respect to the narrowed section of the blood
vessel.
[0004] Despite this advancement in the art, problems still remain.
In U.S. Pat. No. 5,484,412, the entry point of the guidewire and
balloon dilatation catheter into the anchoring catheter is at the
proximal end of the anchoring catheter. Consequently, it is
difficult to maintain the position of the guidewire down the
coronary artery while loading the anchoring catheter onto the back
end of the guidewire. Also, by having the entry point of the
guidewire and balloon dilatation catheter at the proximal end of
the anchoring catheter, the guidewire must extend through the
entire catheter. If the anchoring catheter is loaded on the back of
the guidewire, the guidewire would have to be withdrawn or extended
in length until the wire extended out the back end of the anchoring
catheter to allow the operator to grasp the guidewire while
advancing the anchoring catheter. Furthermore, if the anchoring
catheter needs to be withdrawn or exchanged, it is difficult to
hold the guidewire in place without extending it or exchanging it
for an exchange-length guidewire. It is important for the operator
to have control of the guidewire during advancement or retraction
of the balloon dilatation catheter and/or the anchoring catheter so
as not to lose the guidewire position in the vessel being
treated.
[0005] Known in the art are a variety of means for inserting a
guidewire through the side of a balloon dilatation catheter.
Examples of such devices are disclosed in U.S. Pat. Nos. 5,489,271
and 5,554,118. While these devices assist in inserting or
exchanging a balloon dilatation catheter, they do not incorporate
the use of or the advantages associated with the use of an
anchoring catheter to maintain the position of the guidewire, the
balloon dilatation catheter, and the guiding catheter within the
coronary artery.
[0006] Thus, a primary object of the present invention is to
provide an angioplasty catheter assembly that has an anchoring
catheter with an opening in its side wall so that the guidewire and
balloon dilatation catheter may extend there through.
[0007] Another object of the present invention is to provide an
angioplasty catheter assembly that allows for a guidewire to be
maintained in its position down the coronary artery.
[0008] Yet another object of the present invention is to provide an
angioplasty catheter assembly that does not cause the guidewire to
have to be withdrawn, extended or exchanged for a longer guidewire
to allow the operator to grasp the guidewire while advancing an
anchoring catheter.
[0009] Another object of the present invention is to provide an
angioplasty catheter assembly that helps prevent the loss of the
guidewire position within the coronary artery.
[0010] Another object of the present invention is to provide an
angioplasty catheter assembly having a longitudinal slit along the
anchoring catheter to allow an operator to extend the guidewire
through the tubular wall of the anchoring catheter at multiple
positions.
[0011] These and other objects, features, or advantages of the
present invention will become apparent from the specification and
claims. Although some descriptions of the invention refer to
angioplasty systems, dilatation balloons, balloon dilatation
catheters and treatment of coronary arteries, it should be
understood that such elements are merely exemplary and the
invention can be used in conjunction with a variety of treatment
catheters and in different vessels of the human body. Treatment
catheters can include treatment elements such as, for example,
angioplasty balloons, stents and stent delivery components and
radiation therapy apparatuses.
SUMMARY OF THE INVENTION
[0012] The present invention is for a catheter assembly that uses a
hollow guiding catheter having an elongated hollow anchoring
catheter disposed within. The anchoring catheter has an external
anchoring balloon member that is adapted to inflate to engage the
guiding catheter. Optionally, the anchoring catheter has an
internal anchoring balloon member that is adapted to inflate to
engage and retain a dilatation catheter against movement with
respect to the anchoring catheter. The anchoring catheter
additionally has an opening in its tubular wall in order to allow
the balloon dilatation catheter and/or a guidewire to pass through
the opening and extend out the distal end of the anchoring
catheter. The opening in the tubular wall of the anchoring catheter
can be a longitudinal slit that allows the entry point of the
guidewire and balloon dilatation catheter to change.
DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a sectional view of an angioplasty catheter
assembly in accordance with the invention, shown within a coronary
artery.
[0014] FIG. 2 is an enlarged cross-sectional view taken on line 2-2
of FIG. 1.
[0015] FIG. 3 is a large scale sectional-perspective view of the
forward or distal ends of the balloon dilatation, anchoring and
guiding catheters in accordance with the invention.
[0016] FIG. 4 is a sectional view of an alternative embodiment of
the angioplasty catheter assembly wherein the opening in the
tubular member of the anchoring catheter is a slit.
[0017] FIG. 5 is a cross-sectional view of the guide member of an
enlarged scale taken on line 5-5 of FIG. 4.
[0018] FIG. 6 is an end view of an anchoring catheter tube wall
embodiment having tongue and groove members sealing the elongated
longitudinal slit.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0019] The present invention is an improvement over the catheter
assembly disclosed in U.S. Pat. No. 5,484,412 incorporated by
reference in its entirety herein. The angioplasty catheter assembly
10 of the present invention is shown in FIG. 1. The catheter
assembly 10 is placed within a coronary artery 12 having plaque or
obstruction 14. Reference numeral 16 reveals a conventional
guidewire over which a treatment or balloon dilatation catheter 18
is slidably mounted. In this example, an over-the-wire balloon
dilatation catheter is described, but other treatment catheters may
be used such as a rapid exchange dilatation catheters or stent
delivery catheters. Dilatation catheter 18 has an inflatable
balloon 20 on the distal end thereof and has its internal diameter
divided by membrane 22 to create a balloon inflation passageway or
lumen 24 and a guidewire passageway or lumen 26 as shown in FIG.
2.
[0020] The balloon dilatation catheter 18 and guidewire 16 are
slidably mounted within the hollow interior or lumen 27 of an
anchoring catheter 28. The anchoring catheter 28 has an outer
tubular wall 30 having distal and proximal ends and an opening 32,
through which the balloon dilatation catheter 18 and guidewire 16
are slidably mounted. Optionally, the outer wall 30 of the
anchoring catheter 28 has at least one and possibly two hollow
elongated internal balloon inflation passageways 34, each of which
has a port 36. In this optional embodiment, one or more flexible
internal anchoring balloons 38 extend inwardly within the hollow
interior of the anchoring catheter 28 and extend over ports 36.
[0021] The outer wall 30 of anchoring catheter 28 has one or more
external balloon passageways 40 each having an external port 42. A
first concentric anchoring external balloon 44 extends outwardly
from wall 30 over a single port 42, and a second external
concentric anchoring balloon 46 also extends over a port 42.
Opening 32 may be disposed proximally of, and preferably adjacent
to, balloon 44. Optionally, a plurality of blood perfusion ports 48
extend through the wall of anchoring catheter 28 at locations both
proximal and distal of balloon 46. The anchoring catheter 28 is
adapted to be disposed through guiding catheter 50.
[0022] In operation, as an example, the guiding catheter 50 is
inserted into the groin of the patient and positioned at the origin
of the coronary artery 12. The balloon dilatation catheter 18 is
inserted over guidewire 16 and both the guidewire 16 and balloon
dilatation catheter 18 are then inserted through opening 32 of
anchoring catheter 28. The assembled balloon dilatation catheter 18
and anchoring catheter 28 are moved as a unit through guiding
catheter 50. At this point in time, the external balloons 44 and 46
of anchoring catheter 28 are still deflated.
[0023] The above-described assembled components are extended
through the guiding catheter 50 until the guidewire 16 and the
distal end of the anchoring catheter 28 extend distally beyond the
distal end of the guiding catheter 50. At that point in time, the
external balloons 44 and 46 are inflated. The external balloon 46
engages the inner wall of coronary artery 12 while the external
balloon 44 engages the interior of guiding catheter 50. This
secures the guiding catheter 50 to the coronary artery 12. The
balloon dilatation catheter 18 is now moveable independent of the
anchoring catheter 28 and is thereupon moved to a position where
the dilatation balloon 20 is adjacent to plaque or obstruction
14.
[0024] When inflated within coronary artery 12, external balloon 46
also temporarily occludes or blocks blood flow through coronary
artery 12, unless the selected embodiment of anchoring catheter 28
includes optional perfusion ports 48, as described above. Temporary
occlusion at a vessel location proximal to targeted obstruction 14
is useful to prevent distal embolization by plaque debris that may
be dislodged during angioplasty and subsequently entrained in the
blood flow. Proximal occlusion to prevent distal embolization
typically includes the aspiration of potentially contaminated blood
following dilatation, but prior to deflating balloon 46, which
allows blood flow to resume. Aspiration can be performed through
interior lumen 27 of anchoring catheter 28 by drawing a partial
vacuum at the proximal end thereof, using for example, a
syringe.
[0025] Other methods of inserting the catheter assembly 10 into the
artery 12 can be used depending upon need and preference. For
example, the guidewire 16 may be inserted through the proximal end
of the guiding catheter 50 to its desired position. Then, the
anchoring catheter 28 can be loaded on the proximal end of the
guidewire 16 by inserting the proximal end of guidewire 16 into the
distal end of the anchoring catheter 28, extending the wire 16
proximally through the lumen 27 of anchoring catheter 28, and then
exiting from the anchoring catheter 28 through opening 32. The
anchoring catheter 28 can then be advanced distally through the
guiding catheter 50 and into position extending distally there
from, while the guidewire 16 is manually held in position. The
balloon dilatation catheter 18 is then loaded on the proximal end
of the guidewire 16, is advanced through guiding catheter 50,
enters anchoring catheter 28 through opening 32, and follows the
guidewire 16 to its desired position in the artery.
[0026] Alternatively, the balloon catheter 18 may be loaded onto
the guidewire 16 and advanced through guiding catheter 50 into the
vessel to be treated. The clinician may decide to use the anchoring
catheter 28, which is then loaded onto the balloon dilatation
catheter 18 before advancing the anchoring catheter 28 to its
desired position. Such a maneuver requires the proximal end of
balloon catheter 18 to be small enough to allow anchoring catheter
28 to pass there over. Such a low profile can be achieved by
temporarily removing any proximal fitting(s) mounted on balloon
catheter 18, as will be recognized by one of skill in the art of
balloon catheters.
[0027] Once the catheter assembly 10 is in place, the position of
the guidewire 16 can be maintained if either the balloon dilatation
catheter 18 or the anchoring catheter 28 needs to be withdrawn and
exchanged. For example, if the operator advances the guidewire 16
down the coronary artery 12 but cannot subsequently advance the
balloon dilatation catheter 18 over the guidewire 16, then the
guidewire 16 can remain in place as the balloon dilatation catheter
18 is removed and another treatment catheter is loaded onto the
proximal end of the guidewire 16. Similarly, if the anchoring
catheter 28 is obstructing advancement of the balloon dilatation
catheter 18 or malfunctions, anchoring catheter 28 can be withdrawn
and/or exchanged while the intracoronary position of guidewire 16
is maintained. Thus, an operator is able to grasp the guidewire 16
while advancing or withdrawing the balloon dilatation catheter 18
or the anchoring catheter 28, thus giving the operator control of
the guidewire 16 during the assembly, withdrawal, or exchange of
the balloon dilatation catheter 18 and/or the anchoring catheter
28. This prevents the operator from losing the guidewire 16
position in coronary artery 12, such as withdrawing the guidewire
16 from its desired position.
[0028] In an alternative embodiment, as shown in FIG. 4, the
opening 32 in the outer wall 30 of the anchoring catheter 28 is
comprised of an elongated longitudinal opening or slit 52 that
extends from the proximal end of the anchoring catheter 28 towards
the distal end of the anchoring catheter 28. Slit 52 also extends
transversely from the outer wall 30 of anchoring catheter 28 to the
lumen 27 thereof. The slit 52 may be considered as defining a pair
of flaps 54 which normally close together at the slit 52.
[0029] Slidably mounted on the anchoring catheter 28 is a guide
member 56. The guide member 56 facilitates the insertion of the
balloon dilatation catheter 18, and/or the guidewire 16
transversely through the slit 52 in the anchoring catheter 28. The
guide member 56 has distal and proximal ends and a first passageway
58 that extends through the length of guide member 56 and receives
the anchoring catheter 28. The guide member 56 also has a second
passageway 60 that extends from the proximal end of the guide
member 56 and into the first passageway 58 before reaching the
distal end of the guide member 56. The second passageway 60
receives the guidewire 16 and/or the balloon dilatation catheter
18. As shown in FIG. 5, a spreader member 62 is formed in the body
of the guide member 56 and projects into the first passageway 58
adjacent the distal end of the first passageway 58.
[0030] Wherever the guide member 56 is slidably positioned along
the anchoring catheter 28, the spreader 62 engages and extends
through the slit 52 to spread flaps 54 apart, thus allowing
transverse access to the lumen 27 of anchoring catheter 28 by the
guidewire 16 and/or the balloon dilatation catheter 18 as they
extend through the second passageway 60. Under the influence of the
inherent resiliency of the flaps 54 of the outer wall 30 of the
anchoring catheter 28, the flaps 54 will draw together to close the
slit 52 of the anchoring catheter 28.
[0031] The guide member 56 can be moved along the length of the
anchoring catheter 28 to allow the physician to adjust the
insertion point created by the spreader member 62 in the slit 52.
This provides the physician greater flexibility and control to
assemble, withdraw, or exchange either the balloon dilatation
catheter 18 or the anchoring catheter while maintaining the desired
position of the guidewire 16.
[0032] To ensure that there is not excessive leakage through the
elongated longitudinal slit 52, several interlocking flap designs
may be used for sealing of the flaps 54 of the elongated
longitudinal slit 52. Examples of these sealing methods for
adaptation to the slit 52 of the anchoring catheter 28 are shown in
U.S. Pat. No. 5,171,222 incorporated by reference herein. As one
example, one edge of flap 54 has a tongue member 64 that extends
along the length of slit 52 and the edge of the opposite flap 54
has a groove member 66 that likewise extends along the length of
slit 52 as shown in FIG. 6. The stiffness of the outer wall 30
forces flaps 54 together such that the tongue member 64 interlocks
with the groove member 66 under pressure to create a seal. The
flaps 54 and the tongue member 64 and groove member 66 are
preferably made of a soft elastomer that is separable such that the
spreader member 62 separates the flaps 54 to create an opening in
the slit 52. One skilled in the art would know that this is just
one example of how the elongated longitudinal slit could be sealed
to help prevent leakage.
[0033] It is therefore seen that this invention will accomplish at
least all of its stated objectives.
* * * * *