U.S. patent application number 10/745724 was filed with the patent office on 2004-07-15 for inflatable cannula.
This patent application is currently assigned to Edwards Lifesciences Corp.. Invention is credited to Hahnen, Kevin.
Application Number | 20040138614 10/745724 |
Document ID | / |
Family ID | 22445375 |
Filed Date | 2004-07-15 |
United States Patent
Application |
20040138614 |
Kind Code |
A1 |
Hahnen, Kevin |
July 15, 2004 |
Inflatable cannula
Abstract
An expandable lumen cannula which includes an elongate tube
having a proximal end, a distal end, an intermediate flexible
region, and a lumen therebetween. The cannula further includes a
balloon occluder mounted on the distal end of the tube. The
intermediate flexible region of the tube further includes an
elongate generally cylindrical balloon disposed circumferentially
about the flexible region which, upon inflation, expands the
luminal diameter of the intermediate region. First and second
inflation ports are in fluid communication with the balloon
occluder and the cylindrical balloon. The cannula may optionally
include a cardioplegia port disposed within the distal region of
the tube, proximal the balloon occluder and distal the generally
cylindrical balloon. Methods of using such a cannula are also
disclosed, particularly to provide cannulation through a minimally
invasive port incision, and to thereafter displace the tissues and
organs adjacent an intercostal access port upon inflation and
expansion of the generally cylindrical balloon.
Inventors: |
Hahnen, Kevin; (Westlake
Village, CA) |
Correspondence
Address: |
O'MELVENY & MEYERS
114 PACIFICA, SUITE 100
IRVINE
CA
92618
US
|
Assignee: |
Edwards Lifesciences Corp.
Irvine
CA
|
Family ID: |
22445375 |
Appl. No.: |
10/745724 |
Filed: |
December 23, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10745724 |
Dec 23, 2003 |
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09751445 |
Dec 29, 2000 |
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6679871 |
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09751445 |
Dec 29, 2000 |
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09130585 |
Aug 7, 1998 |
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6168586 |
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Current U.S.
Class: |
604/96.01 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 17/12136 20130101; A61B 17/12109 20130101; A61B
2017/00557 20130101; A61M 25/10 20130101; A61M 2025/1052
20130101 |
Class at
Publication: |
604/096.01 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. An expandable lumen cannula, comprising: an elongate tubular
member having an outer wall, a proximal end, a distal end, and a
lumen therebetween, wherein the elongate tubular member is
expandable from a compressed condition to an expanded condition;
and an elongate balloon having a proximal opening and a distal
opening, said elongate balloon being circumferentially disposed
about the elongate tubular member, wherein a plurality of
connections are formed between the outer wall of the elongate
tubular member and the elongate balloon.
2. The expandable lumen cannula of claim 1, wherein the elongate
balloon further comprises an inner wall, wherein the proximal
opening of the elongate balloon is sealed in a fluid-tight manner
to the proximal end of the elongate tubular member, and the distal
opening of the elongate balloon is sealed in a fluid-tight manner
to the distal end of the elongate tubular member, and wherein a
space is formed between the outer wall of the elongate tubular
member and the inner wall of the elongate balloon.
3. The expandable lumen cannula of claim 2, further comprising an
inflation lumen, wherein the inflation lumen is in fluid
communication with the space formed between the outer wall of the
elongate tubular member and the inner wall of the elongate
balloon.
4. The expandable lumen cannula of claim 3, wherein the elongate
tubular member is expandable from a compressed condition to an
expanded condition when fluid is introduced through the inflation
lumen into the space formed between the outer wall of the elongate
tubular member and the inner wall of the elongate balloon.
5. The expandable lumen cannula of claim 1, wherein the elongate
tubular member comprises any combination of polyethylene
tetraflouride, extruded urethane, and nylon.
6. The expandable lumen cannula of claim 1, wherein the elongate
balloon comprises any combination of silicon, latex, and
polyurethane.
7. The expandable lumen cannula of claim 1 further comprising an
elongate cylindrical sleeve surrounding the elongate balloon.
8. The expandable lumen cannula of claim 1, wherein the elongate
balloon is toroidal, forming a lumen between its proximal opening
and its distal opening.
9. The expandable lumen cannula of claim 8, wherein the plurality
of connections are formed between the outer wall of the elongate
tubular member and the lumen of the elongate balloon.
10. The expandable lumen cannula of claim 1, wherein the distal end
of the elongate tubular member is at an angle relative to its
proximal end.
11. The expandable lumen cannula of claim 10, further comprising a
balloon occluder disposed about the distal end of the elongate
tubular member.
12. The expandable lumen cannula of claim 1, wherein the proximal
end of the elongate tubular member is adapted for attachment to a
cardiopulmonary bypass machine.
13. An expandable lumen cannula, comprising: a first elongate
tubular member having a proximal end, a distal end, and a lumen
therebetween; a second elongate tubular member having an outer
wall, a proximal end, a distal end, and a lumen therebetween, the
proximal end being connected to the distal end of the first
elongate tubular member, and the lumen of the second elongate tube
being in fluid communication with the lumen of the first elongate
tubular member; and an elongate balloon having a proximal opening
and a distal opening, wherein the elongate balloon is disposed
circumferentially about the second elongate tubular member.
14. The expandable lumen cannula of claim 13, wherein a plurality
of connections are formed between the outer wall of the second
elongate tubular member and the elongate balloon.
15. The expandable lumen cannula of claim 13, wherein the proximal
opening of the elongate balloon is sealed in a fluid-tight manner
to the proximal end of the second elongate tubular member, and
wherein the distal opening of the elongate balloon is sealed in a
fluid-tight manner to the distal end of the second elongate tubular
member.
16. The expandable lumen cannula of claim 15, wherein the elongate
balloon comprises an inner wall, and a space is formed between the
inner wall of the elongate balloon and the outer wall of the second
elongate tubular member.
17. The expandable lumen cannula of claim 16, further comprising an
inflation lumen, wherein the inflation lumen is in fluid
communication with the space formed between the inner wall of the
elongate balloon and the outer wall of the second elongate tubular
member.
18. The expandable lumen cannula of claim 13, wherein the second
elongate tube is expandable from a compressed condition to an
expanded condition.
19. The expandable lumen cannula of claim 13, wherein the distal
end of the second elongate tubular member is at an angle relative
to its proximal end.
20. The expandable lumen cannula of claim 19, further comprising a
balloon occluder mounted on the distal end of the second elongate
tubular member.
21. The expandable lumen cannula of claim 20, further comprising a
cardioplegia lumen extending distally from the first elongate
tubular member and communicating with a cardioplegia port proximal
the balloon occluder.
22. The expandable lumen cannula of claim 13, wherein the proximal
end of the first elongate tubular member is adapted for attachment
to a cardiopulmonary bypass machine.
23. The expandable lumen cannula of claim 14, wherein the elongate
balloon is toroidal, forming a lumen between its proximal opening
and its distal opening.
24. The expandable lumen cannula of claim 23, wherein the plurality
of connections are formed between the outer wall of the second
elongate tubular member and the lumen of the elongate balloon.
25. An expandable lumen cannula, comprising: an elongate tubular
member having an outer wall, a proximal region, a distal region,
and a lumen therebetween, wherein the distal region has a proximal
end and a distal end; and an elongate balloon having a proximal
opening and a distal opening, said elongate balloon being disposed
circumferentially about the distal region of the elongate tubular
member.
26. The expandable lumen cannula of claim 25, wherein a plurality
of connections are formed between the outer wall of the elongate
tubular member and the elongate balloon.
27. The expandable lumen cannula of claim 25, wherein the proximal
opening of the elongate balloon is sealed in a fluid-tight manner
to the proximal end of the distal region of the elongate tubular
member, and wherein the distal opening of the elongate balloon is
sealed in a fluid-tight manner to the distal end of the distal
region of the elongate tubular member.
28. The expandable lumen cannula of claim 27, wherein the elongate
balloon comprises an inner wall, and a space is formed between the
inner wall of the elongate balloon and the outer wall of the
elongate tubular member.
29. The expandable lumen cannula of claim 28, further comprising an
inflation lumen, wherein the inflation lumen is in fluid
communication with the space formed between the inner wall of the
elongate balloon and the elongate tubular member.
30. The expandable lumen cannula of claim 25, wherein the distal
region of the elongate tubular member is expandable from a
compressed condition to an expanded condition.
31. The expandable lumen cannula of claim 25, wherein the distal
end of the distal region of the elongate tubular member is at an
angle relative to the proximal end of the distal region.
32. The expandable lumen cannula of claim 31, further comprising a
balloon occluder mounted on the distal end of the distal region of
the elongate tubular member.
33. The expandable lumen cannula of claim 32, further comprising a
cardioplegia lumen extending distally from the proximal region of
the elongate tubular member and communicating with a cardioplegia
port proximal the balloon occluder.
34. The expandable lumen cannula of claim 25, wherein the proximal
end of the proximal region of the elongate tubular member is
adapted for attachment to a cardiopulmonary bypass machine.
35. The expandable lumen cannula of claim 26, wherein the elongate
balloon is toroidal, forming a lumen between its proximal opening
and its distal opening.
36. The expandable lumen cannula of claim 35, wherein the plurality
of connections are formed between the outer wall of the elongate
tubular member and the lumen of the elongate balloon.
Description
[0001] This is a divisional of U.S. application Ser. No.
09/751,445, filed Dec. 29, 2000, which is a continuation-in-part of
U.S. application Ser. No. 09/130,585, filed on Aug. 7, 1998, now
issued as U.S. Pat. No. 6,168,586, all of which are herein
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] This invention relates generally to a cannula or catheter
that can be introduced to a small port and be inflated to
accommodate a large flow of fluids, or can serve as a conduit or
port to apply other medical therapy, such as surgical instruments,
dilatation catheters, atherectomy devices, filters, aspirators, and
pressure monitors.
BACKGROUND OF THE INVENTION
[0003] Minimally invasive surgical procedures which use an
endoscopic approach have been widely used in many surgical
specialties, including cardiothoracic surgery. New surgical
techniques and instruments have been developed especially to assist
in minimally invasive coronary bypass grafting. This procedure is
often performed using the port access approach where a minimal
access incision is made in the intercostal space rather than the
traditional midsternotomy approach, therefore minimizing trauma to
the chest wall. After the incision is made, various instruments can
be inserted through the incision and various tissue layers to reach
the heart and great vessels. This peripherally-based system
achieves aortic occlusion, cardioplegia delivery, and left
ventricular decompression; thus, coronary revascularization and
various cardiac procedures can be effectively performed.
[0004] Traditionally, flexible catheters or cannulas are fixed in
their lumen and outside diameter size. In order to provide a large
lumen for oxygenated blood flow during cardiopulmonary bypass
(CPB), a traditional catheter or cannula is required to have a
large diameter, therefore making insertion and tissue penetration
difficult through a small port. A rigid trocar provides adequate
luminal dimension; however, it is also limited in its ability to
expand and provide easy access. Therefore, a need exists for a
fluid or medical instrument delivery catheter or cannula having a
flexible and expandable wall and a capability of achieving a
minimal profile for entry through a small port, and having an
ability to thereafter expand to accommodate a larger luminal
diameter for delivery of fluid and instruments.
SUMMARY OF THE INVENTION
[0005] The present invention is particularly useful in minimally
invasive coronary artery bypass grafting (CABG) since this
procedure is generally performed through a small incision. In one
embodiment, the invention provides a cannula comprising an elongate
tubular member having a proximal end, a distal end, an expandable
region, and a lumen. An elongated tubular or cylindrical balloon is
disposed circumferentially about the expandable region of the tube.
The cylindrical balloon has an inflation port and upon inflation
itself expands and also causes the expandable region of the cannula
to expand, thus enlarging the luminal diameter of the expandable
region. The elongated cylindrical balloon is sealed at its ends to
the outer wall of the cannula forming an inflatable space between
the outer wall of the expandable region of the cannula and the
inner wall of the cylindrical balloon.
[0006] In another embodiment, the invention provides an expandable
lumen cannula comprising an elongate tubular member having an outer
wall, a proximal end, a distal end, and a lumen therebetween. The
elongate tubular member is expandable from a compressed condition
to an expanded condition, and an elongate balloon having a proximal
opening and a distal opening is circumferentially disposed about
the elongate tubular member. A plurality of connections connects
the outer wall of the elongate tubular member to the inner wall of
the elongate balloon. Alternatively, the elongate balloon can be
toroidal, forming a lumen from its proximal opening to its distal
opening. In this embodiment, the outer wall of the elongate tubular
member can be connected to the lumen of the elongate balloon
through 1) a series of random connections, 2) a predetermined
pattern of connections, or 3) in one continuous seal formed between
the outer wall of the elongate tubular member and the lumen of the
elongate balloon.
[0007] In another embodiment, a balloon occluder is mounted at the
distal end of the cannula. Each of the balloon occluder and the
cylindrical balloon has its own inflation port. In another
embodiment, the cannula has an additional lumen extending distally
from the proximal end to a port proximal to the balloon occluder
for delivering cardioplegic solution. In other embodiments, the
cannula will further include one or more helical threads disposed
about the distal end of the tube proximal to the balloon occluder
and distal to the cylindrical balloon.
[0008] In yet another embodiment, the present invention provides an
expandable lumen cannula comprising a first elongate tubular member
having a proximal end, a distal end, and a lumen therebetween, and
a second elongate tubular member having an outer wall, a proximal
end, a distal end, and a lumen therebetween. The second elongate
tubular member is expandable and flexible. The proximal end of the
second elongate tubular member is connected to the distal end of
the first elongate tubular member, and their lumens are in fluid
communication with each other. An elongate tubular or cylindrical
balloon is disposed circumferentially about the second elongate
tubular member, and a plurality of connections is formed between
the outer wall of the second elongate tubular member and the
elongate balloon.
[0009] The elongate balloon can be formed so that it has openings
on its proximal and distal ends, which are sealed in a fluid-tight
manner to the proximal and distal ends of the second elongate
tubular member. A space can thus be formed between the outer wall
of the second elongate tubular member and the inner wall of the
elongate balloon. The connections can be between the outer wall of
the second elongate tubular member and the inner wall of the
elongate balloon. An inflation port in communication with the space
formed between the second elongate tubular member and the elongate
balloon can be used to inflate the elongate balloon with fluid. The
fluid will be trapped in the space between the outer wall of the
elongate tubular balloon and the inner wall of the elongate balloon
and will cause an outward force, thus forcing the elongate balloon
to expand and inflate. The inflation of the elongate balloon will
in turn cause an outward force on the connections between the
elongate balloon and the second elongate tubular member. This force
will cause those connections to pull the wall of the second
elongate tubular member radially outward, thus increasing the
luminal diameter of the second elongate tubular member.
[0010] In an alternative embodiment, the elongate tubular or
cylindrical balloon is toroidal in shape so that it forms a lumen
from its proximal opening to its distal opening. The expandable
lumen cannula is formed by inserting the second elongate tubular
member through the lumen of the elongate balloon. In this
embodiment, the connections previously described can be between the
outer wall of the second elongate tubular member and the lumen of
the elongate balloon. The outer wall of the elongate tubular member
can also be sealed in a fluid-tight manner to the lumen of the
elongate balloon, which can be one continuous seal along the entire
length of the lumen of the elongate balloon. The elongate balloon
can further comprise an inflation port for inflating the
balloon.
[0011] The present invention provides an expandable lumen cannula
which assists in minimally invasive aortic cannulation. The
expandable lumen cannula is inserted through a port access,
advancing the distal end into the ascending aorta. Fluid is
introduced into the space formed between the inner wall of the
cylindrical balloon and the outer wall of the flexible region of
the cannula. The introduction of the fluid causes the cylindrical
balloon and the flexible region of the cannula to expand, thereby
causing the luminal diameter of the flexible region of the cannula
to increase. Oxygenated blood then can be infused through the lumen
of the cannula into the aorta. In alternative methods, the expanded
lumen of the cannula can be used to insert medical devices for the
performance of surgical procedures within the aorta, carotid
arteries, or any other internal body structure accessible by
cannulation.
[0012] In alternative methods, an expandable lumen cannula further
comprises a balloon occluder at its distal end in fluid
communication with an inflation lumen and an inflation port. The
expandable lumen cannula is inserted through a port access,
advancing the distal end into the ascending aorta. The balloon
occluder is inflated to occlude the ascending aorta, followed by
inflation of the cylindrical balloon, thereby increasing the
diameter of the cannula lumen. Oxygenated blood then can be infused
through the lumen of the cannula into the aorta distal to the
balloon occluder. In alternative methods, the expanded lumen of the
cannula can be used to insert medical devices for the performance
of surgical procedures within the aorta, carotid arteries, or any
other internal body structure accessible by cannulation.
[0013] It will be understood that there are many advantages to
using an inflatable cannula as disclosed herein. For example, the
inflatable cannula of the invention can be used (1) to provide easy
introduction of the cannula through a small port, (2) to provide an
expanding tube that serves to gently move nearby organs and tissues
out of the path during surgery, (3) to provide a conduit or port to
apply other medical therapies, e.g., surgical instruments,
dilatation catheters, atherectomy devices, filters, aspirators,
pressure monitors, etc., (4) to provide an inflatable lumen which
can accommodate large flow of fluid, e.g., oxygenated blood, into
the aorta or other internal body structure, (5) to provide better
contact and therefore stabilization between the cannula and the
arterial wall by having cannula threads at the point of contact
with the vessel wall, (6) to provide interruption of arterial flow
through inflating the balloon occluder, thus minimizing damage to
the arterial wall and reducing the risk of emboli dislodgment as
compared to traditional clamping.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 depicts an embodiment of an inflatable cannula.
[0015] FIG. 2 is an oblique view of the inflatable cannula.
[0016] FIG. 3 depicts an embodiment of an inflatable cannula having
a cardioplegia lumen and port.
[0017] FIG. 4 is an oblique view of the inflatable cannula having
the cardioplegia lumen and port.
[0018] FIG. 5 depicts the deflated state of the inflatable
cannula.
[0019] FIG. 6 depicts the position of the inflatable cannula
deployed within the ascending aorta during cardiac surgery.
[0020] FIG. 7 depicts an embodiment of an inflatable cannula in a
deflated state.
[0021] FIG. 8 is a cross-section taken through line 8-8 of FIG.
7.
[0022] FIG. 9 depicts the inflatable cannula of FIG. 7 in an
inflated state.
[0023] FIG. 10 is a cross-section taken through line 10-10 of FIG.
9.
[0024] FIG. 11 depicts another embodiment of an inflatable
cannula.
[0025] FIG. 12 is a perspective view of an embodiment of an
inflatable cannula from the distal end of the cannula.
[0026] FIG. 13 is a perspective view of the inflatable cannula
depicted in FIG. 12 from the proximal end of the cannula.
[0027] FIG. 14A is a cross-section taken along lines 14-14 of FIG.
13.
[0028] FIG. 14B is a cross-section taken along lines 14-14 of FIG.
13, showing an alternative embodiment of the inflatable cannula
depicted in FIG. 13.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] The devices and methods of the invention facilitate
cannulation of the aorta through a minimally invasive port access
incision during minimally invasive CABG surgery. In addition, the
invention facilitates thorascopic and/or endovascular delivery of
cardioplegic fluid to the myocardium so as to paralyze the heart.
The invention also provides devices and methods to accommodate
large flow of oxygenated blood during cardiopulmonary bypass
without need for peripheral access. Once the patient is on
cardiopulmonary bypass, a variety of thorascopic, endovascular, or
open surgical procedures may be performed, including coronary
artery bypass grafting (CABG), heart valve repair, and replacement,
septal defect repair, removal of atrial myxoma, patent foramen
ovale closure, treatment of aneurysms, myocardial drilling,
electrophysiological mapping and ablation, and correction of
congenital defects.
[0030] FIG. 1 depicts an embodiment of an inflatable cannula. The
cannula has a proximal region 1, intermediate region 2, and a
distal region 3. The proximal region 1 has tube 6 comprising a
fixed lumen 8. Inflation ports 4 and 5 arise from the junction of
the proximal and intermediate region. Inflation port 4 is
responsible for inflating the balloon occluder. Inflation port 5 is
responsible for inflating the cylindrical balloon. Intermediate
region 2 comprises the inflatable cylindrical balloon 10,
expandable cannula 18 with lumen 9, and balloon occluder lumen
15.
[0031] FIG. 2 depicts an oblique view of the inflatable cannula.
Distal region 3 includes an angulated lumen port 12 for delivery of
blood products and other instruments, and the balloon occluder 13
with its communicating inflation lumen 15. Helical threads 14 are
located on the distal cannula close to the junction of the
intermediate region.
[0032] FIG. 3 depicts an embodiment of an inflatable cannula having
an optional cardioplegia lumen 7 and cardioplegia ports 11 at the
distal end.
[0033] FIG. 4 depicts an oblique view of an inflatable cannula
having cardioplegia lumen 7 and cardioplegia port 11 at the distal
end thereof.
[0034] FIG. 5 depicts an inflatable cannula in the deflated
condition. As can be seen, deflation of cylindrical balloon 10
minimizes the cross-sectional diameter of the inflatable cannula
for access to a minimal incision port.
[0035] FIG. 6 shows an inflatable cannula deployed within the
ascending aorta 17 during cardiac surgery. Balloon occluder 13
provides a gentle seal against the aortic wall. Blood products or
instruments can be delivered through the end port 12 of the cannula
downstream to the aorta, while cardioplegia can be delivered
through cardioplegia port 11 upstream to the heart.
[0036] FIG. 7 shows an inflatable cannula in the deflated
condition. As can be seen, the inflatable cannula comprises a
proximal region 1, and a distal region 2. The proximal region
includes a tube 6 having a fixed lumen 8 and an inflation port 5 in
fluid communication with an inflation lumen 16. The distal region 2
includes an expandable cannula 18 having a lumen 9, an elongate
cylindrical balloon 10, and space 19 formed between the inner wall
of the elongate cylindrical balloon 10 and the outer wall of the
expandable cannula 18.
[0037] The inner wall of the elongate cylindrical balloon 10 is
connected at various points to the out wall of the expandable
cannula 18. These connections 21 can either be at random points or
can be formed in a predetermined pattern. Thus, when the elongate
cylindrical balloon 10 inflates, it exerts an outward expanding
force on the expandable cannula 18, so that the expandable cannula
also expands and increases in luminal diameter.
[0038] The expandable cannula 18 can be made from such materials as
Polyethylene Tetraflouride (Teflon@), urethane, nylon, or any other
semi-rigid and expandable material or suitable medical grade
plastic. In a preferred embodiment, the flexible cannula 18 is
non-elastic.
[0039] The elongate cylindrical balloon 10 is made of an
elastomeric material and is also expandable. It can be made from
such materials as silicon, latex, polyurethane, polyimide or any
other expandable and elastomeric material. Furthermore, the
elongate cylindrical balloon 10 is more flexible and expandable
than the expandable cannula 18.
[0040] The proximal end of the expandable cannula 18 can be
connected to or integrally formed with the distal end of the tube 6
so that lumen 8 of the tube 6 and lumen 9 of the expandable cannula
18 are in fluid communication. The elongate balloon 10 has openings
at its proximal and distal ends. The proximal opening of the
elongate cylindrical balloon 10 is sealed around the circumference
of the proximal end of the expandable cannula 18 in a fluid-tight
manner. Inflation lumen 16 is in fluid communication with the space
19 either through an opening on the wall of the elongate
cylindrical balloon 10, or through an opening in the proximal end
of the elongate cylindrical balloon 10, such as an opening in the
seal formed between the proximal opening of the balloon 10 and the
proximal end of the expandable cannula 18. In the latter case, the
proximal end of the elongate cylindrical balloon 10 is sealed in a
fluid tight manner around the combination of the inflation lumen 16
and the expandable cannula 18. The distal opening of the elongate
cylindrical balloon 10 is sealed around the circumference of the
distal end of the expandable cannula 18 in a fluid-tight
manner.
[0041] FIG. 8 shows a cross section of the distal region 2 of the
inflatable cannula when the cannula is in a deflated condition. It
is apparent that the elongate cylindrical balloon 10 is wrapped
closely around the expandable cannula 18, thus compressing the
expandable cannula 10. In this state, the luminal diameter of the
expandable cannula 18 is at its minimum value. The diameter of the
combination of the expandable cannula 18 and elongate cylindrical
balloon 10 is also at its minimum value. The outer wall of the
expandable cannula 18 and the inner wall of the elongate balloon 10
are joined at connections 21, which may be randomly spaced or made
in predetermined patterns.
[0042] In an alternative embodiment, an elongate cylindrical sleeve
(not shown) with little or no expansion properties can be used to
compress the combination of the expandable cannula 18 and the
elongate cylindrical balloon 10. The sleeve can have a diameter
that is smaller than the diameter of the expandable cannula 18 when
the expandable cannula 18 is in its expanded state. The sleeve can
be the length of the expandable cannula 18 or the elongate
cylindrical balloon 10. The sleeve is also removable so that when
it is removed the elongate cylindrical balloon 10 can be inflated
thus expanding the luminal diameter of the expandable cannula 18,
as well as the luminal diameter of the combination of the
expandable cannula 18 and the elongate cylindrical balloon 10.
[0043] In a method of using such an inflatable cannula, an incision
is made in the patient, for example, on the aortic wall of the
patient. The distal end of the inflatable cannula is then inserted
through the incision into the aorta. The sleeve is then removed by
such methods as pulling it proximally until it no longer covers the
elongate cylindrical balloon 10. Alternatively it can be cut off or
it can be torn along a perforation along its length. Once the
sleeve is removed, the elongate cylindrical balloon 10 can be
inflated, thus expanding the luminal diameter of the expandable
cannula 18 as well as the luminal diameter of the combination of
the expandable cannula 18 and the elongate cylindrical balloon
10.
[0044] FIG. 9 shows the inflatable cannula of FIGS. 7 and 8 in an
inflated condition. It is apparent that fluid has been introduced
through inflation lumen 16 into space 19 thus expanding the
elongate cylindrical balloon 10. As can be seen, inflation also
causes the luminal diameter of the expandable cannula 18 to
increase. Consequently, the diameter of the combination of the
expandable cannula 18 and the elongate cylindrical balloon 10 also
increases. This increase in the diameter of the combination allows
for displacement of tissue when the distal region is inserted
through an incision.
[0045] FIG. 10 shows a cross-section of the distal region 2 when
the elongate cylindrical balloon is inflated. As can be seen, the
luminal diameter of the expandable cannula 18 is increased,
allowing for passage of blood products and medical instruments.
Furthermore, the luminal diameter of the combination of the
expandable cannula 18 and the elongate cylindrical balloon 10 is
also increased, allowing for displacement of tissue.
[0046] FIG. 11 shows an inflatable cannula having an elongate
cylindrical balloon 10 disposed about a flexible region of the
cannula 18, as well as a balloon occluder inflation lumen 15,
wherein the elongate cylindrical balloon 10 is shown in its
inflated condition. The elongate cylindrical balloon 10 covers
almost the entire length of the expandable cannula 18 and balloon
occluder inflation lumen 15, including the curved distal region 3.
The balloon occluder 13 is circumferentially disposed around the
elongate cylindrical balloon 10. The elongate cylindrical balloon
10 has an opening 20 on its distal end through which the balloon
occluder inflation lumen 15 is fitted. The opening 20 can be sealed
in a fluid-tight manner around the outer wall of the balloon
occluder inflation lumen 15 so that when fluid is introduced into
the elongate cylindrical balloon 10, it does not leak through the
opening and into the balloon occluder 13. Meanwhile, the proximal
and distal openings of the balloon occluder 13 can be sealed in a
fluid-tight manner around the outer wall of the elongate
cylindrical balloon 10.
[0047] The elongate cylindrical balloon 10 can be made of different
materials along its length. For example, along region 2, the
elongate cylindrical balloon 10 can be made of an elastomeric
material such as latex, while the section surrounded by the balloon
occluder 13 can be made of a less elastomeric and more rigid
material such as polyethylene tetraflouride, urethane, nylon, or
any medical grade semi-rigid and expandable plastic.
[0048] In yet another embodiment as shown in FIGS. 12 through 14,
the expandable cannula 18 is surrounded by an elongate cylindrical
balloon 25, which is toroidal in shape. In FIGS. 12 through 14, the
elongate cylindrical balloon 25 and expandable cannula 18 are shown
in an inflated state. In their original state, the balloon 25 is
not inflated and is used to compress the expandable cannula 18.
Alternatively, as described above, a removable elongate cylindrical
sleeve can be used to compress the combination of the balloon 25
and the expandable cannula 18.
[0049] The elongate cylindrical balloon 25 forms a lumen running
along the length of the balloon 25 with openings at its proximal
and distal ends. This embodiment of the inflatable cannula can be
made by inserting the expandable cannula 18 through the lumen of
the balloon 25, so that the distal end of the expandable cannula 18
is protruding through the distal opening of the lumen of the
balloon 25, and the proximal end of the expandable cannula 18
extends proximally from the proximal opening of the lumen of the
balloon 25. The outer wall of the expandable cannula 18 can be
sealed along its length to the lumen of the balloon 25. FIG. 14A
shows a cross-section of the expandable lumen cannula with a
complete seal 23 formed between the outer wall of the expandable
cannula 18 and the lumen of the balloon 25. The outer wall of the
expandable cannula 18 can be glued or otherwise connected in any
manner at predetermined points to the lumen of the balloon 25. FIG.
14B shows the connections 28 formed between the outer wall of the
expandable cannula 18 and the lumen of the balloon 25. These can be
randomly formed along the length of the lumen of the balloon 25.
Alternatively, the lumen of the balloon 25 can be connected to the
outer wall of the expandable cannula 18 in a known pattern, such as
the formation of a series of connecting rings (not shown) at
predetermined intervals along the length of the lumen of the
balloon 25. Inflation of the balloon 25 causes it to expand,
exerting an outward expanding force, thus causing the expandable
cannula 18 to expand and to increase in diameter.
[0050] FIG. 13 shows the opening 26 to which the inflation lumen 16
is sealed in a fluid-tight manner. The elongate cylindrical balloon
25 can be inflated by introducing fluid through the opening 26,
thus expanding the luminal diameter of the balloon 25 and the
luminal diameter of the expandable cannula 18, as well as expanding
the luminal diameter of the combination of the expandable cannula
18 and the balloon 25.
[0051] The length of region 2 will generally be between 10-20
centimeters, more preferably between 12 and 15 centimeters, with a
tube O.D. between 0.3 and 2.0 centimeters, more preferably 0.4-1.0
centimeters, more preferably 0.5-0.7 centimeters, more preferably
approximately 0.6 centimeters. In certain embodiments, the cannula
will have a circular cross-section. In other embodiments, the
cannula will have an oval cross-sectional shape to more easily fit
through the ribs, or it may have any other suitable shape. The
inner diameter of lumen 9, when expanded, will generally be between
0.2 and 2.0 centimeters, more preferably 0.3-1.0 centimeters, more
preferably 0.4-0.8 centimeters. The length of proximal region 1
will generally be between 2 and 10 centimeters, more preferably
about 5 centimeters. The tube diameter and proximal region 1 is
generally 0.3-1.0 centimeters, while the diameter of lumen 8 in
proximal region 1 is about 0.2-0.8 centimeters. In curved distal
region 3, when expanded, the balloon occluder will generally have a
diameter between 1 centimeter and 2.5 centimeters, more preferably
between 1.5 and 2.0 centimeters. The foregoing ranges are set forth
solely for the purpose of illustrating typical device dimensions.
The actual dimensions of a device constructed according to the
principles of the present invention may obviously vary outside of
the listed ranges without departing from those basic
principles.
[0052] It is contemplated that the inflatable cannula disclosed
herein will be used to perform any of the procedures including
coronary artery bypass surgery, valve repair, septal defect repair,
and thoracic aortic aneurysm (TAA) repair. A typical coronary
artery bypass surgery (CABG) using minimally invasive procedures
and the cannula disclosed herein generally begins with incubation
of the patient after induction of anesthesia as explained in
Reichenspurner et al., Annals of Thoracic Surgery 65:413-419
(1998), incorporated herein by reference. The right internal
jugular vein is punctured using a 9 French introduction system for
later insertion of the endopulmonary vent catheter. The patient is
placed in a supine position. A small (6-8 centimeter; medium 7
centimeter) incision is made parasternally between the ribs,
usually on top of the fourth rib. During dissection and removal of
the cartilagenous part of the fourth rib, left internal mammary
artery (LIMA) is dissected free. Thorascopic preparation of the
LIMA is also accomplished through three small lateral chest ports.
When complete visualization of the LIMA is not possible through the
mini-thoracotomy, the inflatable cannula can then assist in the
above endoscopic dissection of LIMA by its ability to accommodate
instruments through its expandable lumen. As the LIMA is being
prepared, a 21 French venous cannula is inserted into the femoral
vein and positioned into the right atrium using transesophageal
echocardiography (TEE).
[0053] Before the initiation of cardiopulmonary bypass (CPB), the
inflatable cannula, in its deflated state, can be inserted through
a small port and guided into the ascending aorta using thoroscopy
and TEE. A Swan-Ganz catheter for pressure monitoring is often
inserted through the right internal jugular vein. As shown in FIG.
7, the elongate cylindrical balloon 10 in its deflated state will
exert a compressive force against the expandable cannula 18,
allowing for insertion of the inflatable cannula through a small
incision. Alternatively, the elongate cylindrical balloon 10 and
expandable cannula 18 can be covered with an elongate cylindrical
sleeve (not shown), which applies a compressive force on both the
balloon 10 and the cannula 18 to reduce the luminal diameter of the
cannula in its deflated state. Once the inflatable cannula has been
inserted through the port, the sleeve can be removed by pulling it
proximally or cutting or tearing it along a longitudinal
perforation.
[0054] After LIMA is prepared for anastomosis, CPB is initiated and
the balloon occluder 13 is inflated with approximately 15-30 cc of
diluted radiological contrast medium using fluoroscopy and TEE. The
balloon occluder 13 is generally placed about 2 centimeters above
the aortic valve with careful monitoring of the right radial artery
pressure to avoid occlusion of the brachiocephalic trunk by the
endo-aortic balloon. The cylindrical balloon 10 is then inflated by
introducing fluid into the space formed between the outer wall of
the expandable cannula 18 and the inner wall of the cylindrical
balloon 10. The introduction of fluid causes the balloon 10 to
expand, thus exerting an outward expanding force on the outer wall
of the expandable cannula 18 through connections 21. Therefore,
inflation causes the luminal diameter of the expandable cannula 18
to increase, thereby allowing for free passage of oxygenated blood
for CPB. Inflation also causes the cylindrical balloon 10 to expand
thereby displacing adjacent tissues and organs.
[0055] After exact positioning of the balloon occluder 13,
cardioplegia can be administered through the optional cardioplegia
port at the distal region of the inflatable cannula. Once
cardioplegic arrest is achieved, an end-to-end anastomosis is
performed of the LIMA to the left anterior descending coronary
artery (LAD). On completion of anastomosis, the balloon occluder
and the cylindrical balloon are deflated, and the cannula is
removed. The heart is reperfused and the patient is weaned from
CPB. After hemostasis is obtained, the femoral cannula is removed,
one chest tube is inserted, and the thoracic and femoral incisions
are closed.
[0056] Similar steps as described above for minimally invasive CABG
can be employed in aortic or mitral valvular replacement. The
inflatable cannula is inserted through a small chest port to reach
the ascending aorta. After the balloon occluder 13 is inflated, the
cylindrical balloon 10 is inflated to expand the luminal diameter
of the expandable cannula 18 to accommodate large flow of
oxygenated blood from the CPB machine. After CPB is initiated, the
damaged aortic or mitral valve can be excised and a prosthetic or
porcine valve can then be sutured in place. After the valve
replacement is complete, the balloon occluder 13 and the
cylindrical balloon 10 are deflated and removed. The patient is
weaned from CPB, a chest tube is placed, and the femoral and chest
incisions are closed.
[0057] Atrial septal defect (ASD) and ventricular septal defect
(VSD) can also be repaired in a similar fashion using the
inflatable cannula disclosed herein. Again, the inflatable cannula
is inserted through a small chest port to reach the ascending
aorta. The cylindrical balloon 10 is inflated following inflation
of the balloon occluder 13 to provide expanded luminal diameter of
the expandable cannula 18 to accommodate large flow of oxygenated
blood from the CPB machine. After CPB is initiated, cardiac
incision is made to expose the ASD or VSD. A mesh is sutured
securely around the defect, and the incision on the heart is
closed. The inflatable cannula is removed after the balloon
occluder 13 and the cylindrical balloon 10 are deflated. After the
patient is weaned from CPB, the chest and femoral incisions are
closed.
[0058] The inflatable cannula can also assist in repair of thoracic
aortic aneurysm (TAA) by providing an expanded conduit for the
oxygenated blood from the CPB machine. After sternotomy, the
expandable cannula can be inserted distal to the aneurysm and
inflated to provide an expanded lumen. The diseased aneurysmal
aorta is resected and replaced with collagen saturated Dacron.TM.
graft. The balloons on the cannula are then deflated and the
cannula is withdrawn after the patient is weaned from CPB.
[0059] In various pediatric cardiac surgeries, such as ASD,
truncous arteriosis, tetralogy of Fallot, anomalous coronary
artery, Ebstein's malformation of the tricuspid valve, heart/lung
transplantation and total anomalous pulmonary vein repair, CPB is
commonly indicated post-operatively due to a low cardiac output
state. The inflatable cannula can easily be left in place
post-operatively to provide easy access to the CPB.
[0060] Although the foregoing invention has, for the purposes of
clarity and understanding, been described in some detail by way of
illustration and example, it will be obvious that certain changes
and modifications may be practiced which will still fall within the
scope of the appended claims.
* * * * *