U.S. patent application number 15/501801 was filed with the patent office on 2017-08-17 for multi-lumen cannulae.
This patent application is currently assigned to Edwars Litesciences Corporation. The applicant listed for this patent is EDWARDS LIFESCIENCES CORPORATON. Invention is credited to WILLIAM T. BILLER, Manouchehr A. Miraki.
Application Number | 20170232238 15/501801 |
Document ID | / |
Family ID | 55264555 |
Filed Date | 2017-08-17 |
United States Patent
Application |
20170232238 |
Kind Code |
A1 |
BILLER; WILLIAM T. ; et
al. |
August 17, 2017 |
MULTI-LUMEN CANNULAE
Abstract
The present disclosure concerns embodiments of multi-lumen
cannulae that can be used in various different medical procedures.
The multi-lumen cannulae can comprise an elongated body comprising
multiple different ports that connect to the various different
sidewall lumens contained within the elongated body. The
multi-lumen cannulae can also comprise a central lumen that extends
through the entire elongated body and can be fluidly connected to
the various different sidewall lumens. The multi-lumen cannulae can
further comprise two balloons on the exterior of the elongated
body, which can be used to isolate the right atrium of a patient's
heart.
Inventors: |
BILLER; WILLIAM T.; (Tustin,
CA) ; Miraki; Manouchehr A.; (Laguna Hills,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EDWARDS LIFESCIENCES CORPORATON |
Irvine |
CA |
US |
|
|
Assignee: |
Edwars Litesciences
Corporation
Irvine
CA
|
Family ID: |
55264555 |
Appl. No.: |
15/501801 |
Filed: |
August 6, 2015 |
PCT Filed: |
August 6, 2015 |
PCT NO: |
PCT/US15/44003 |
371 Date: |
February 3, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62033987 |
Aug 6, 2014 |
|
|
|
Current U.S.
Class: |
604/509 |
Current CPC
Class: |
A61M 2025/105 20130101;
A61M 25/0032 20130101; A61M 1/008 20130101; A61M 2025/0036
20130101; A61M 25/003 20130101; A61M 25/007 20130101; A61M 1/1698
20130101; A61M 2025/004 20130101; A61M 2025/1052 20130101; A61M
2210/125 20130101; A61M 1/3666 20130101; A61M 2025/1015 20130101;
A61M 25/1011 20130101 |
International
Class: |
A61M 25/10 20060101
A61M025/10; A61M 1/36 20060101 A61M001/36; A61M 1/00 20060101
A61M001/00; A61M 1/16 20060101 A61M001/16 |
Claims
1. A multi-lumen cannula, comprising: an elongated body having a
distal end portion for placement in a biological lumen of a patient
and a proximal end portion for placement outside the patient; a
first balloon and a second balloon connected to an exterior surface
of the elongated body in the distal end portion, the first balloon
and the second balloon configured to fluidly isolate a portion of
the biological lumen between the first and second balloons when
inflated; a central lumen extending through the elongated body from
the distal end portion to the proximal end portion; distal fluid
ports and proximal fluid ports in the distal end portion of the
elongated body, at least some of which are fluidly coupled to the
central lumen for conducting fluid between the biological lumen of
the patient and the central lumen, wherein the distal fluid ports
are distal to the first and second balloons and the proximal fluid
ports are proximal to the first and second balloons; at least one
balloon lumen arranged parallel to the central lumen and located
within an outer perimeter of the elongated body; at least one
balloon port that fluidly couples the at least one balloon sidewall
lumen to the first balloon, the second balloon, or both, for
inflation and deflation of the first balloon, the second balloon,
or both; at least one conduction sidewall lumen arranged parallel
to the central lumen and located within the outer perimeter of the
elongated body; and one or more intermediate fluid ports located in
an intermediate region of the distal end portion of the elongated
body between the first and second balloons, and fluidly coupled to
the at least one conduction sidewall lumen.
2. The multi-lumen cannula of claim 1, wherein the at least one
balloon sidewall lumen comprises a first balloon sidewall lumen
fluidly coupled to the first balloon via a first balloon port and a
second balloon sidewall lumen fluidly coupled to the second balloon
via a second balloon port.
3. The multi-lumen cannula of claim 1 or 2, wherein the at least
one conduction sidewall lumen comprises two conduction sidewall
lumens fluidly coupled to the conduction fluid ports.
4. The multi-lumen cannula of any of claims 1-3, further comprising
at least one additional sidewall lumen fluidly coupled to at least
one of the distal fluid ports or at least one of the proximal fluid
ports, or a combination thereof, and arranged parallel to the
central lumen and located within the outer perimeter of the
elongated body.
5. The multi-lumen cannula of any one of claims 1-4, wherein the
first balloon is positioned closest to a distal region of the
distal end portion of the elongated body and wherein the distal
region has a length ranging from about 3 cm to about 20 cm measured
from a distal end of the first balloon to a distal end of the
distal end portion of the elongated body.
6. The multi-lumen cannula of claim 5, wherein the length of the
distal region ranges from about 3 cm to 7 cm.
7. The multi-lumen cannula of claim 5, wherein the length of the
distal region ranges from about 5 cm to about 20 cm.
8. The multi-lumen cannula of any one of claims 1-7, wherein the
second balloon is positioned closest to a proximal region of the
distal end portion of the elongated body and wherein the proximal
region has a length ranging from about 3 cm to about 20 cm measured
from a proximal end of the second balloon to a proximal end of a
last proximal fluid port located in the distal end region.
9. The multi-lumen cannula of claim 8, wherein the length ranges
from about 5 cm to about 20 cm.
10. The multi-lumen cannula of claim 8, wherein the length ranges
from about 3 cm to about 10 cm.
11. The multi-lumen cannula of any of claims 5-10, wherein the
first balloon and the second balloon are separated by a distance of
about 5 cm to about 15 cm measured from a proximal end of the first
balloon to a distal end of the second balloon.
12. The multi-lumen cannula of any of claims 1-11, wherein the
cannula is configured to be introduced into a patient and placed
with a distal region and proximal region of the distal end portion
in the inferior vena cava and superior vena cava, and the
intermediate region adjacent the right atrium.
13. The multi-lumen cannula of claim 12, wherein the first and
second balloons are configured to isolate the inferior vena cava
and superior vena cava from the right atrium.
14. A multi-lumen cannula, comprising: an elongated body having a
distal end portion for placement in a patient's vena cava and a
proximal end portion for placement outside the patient; a first
balloon and a second balloon connected to an exterior surface of
the elongated body in the distal end portion, the first balloon for
placement in the patient's inferior vena cava and the second
balloon for placement in the patient's superior vena cava, the
first balloon and the second balloon configured to fluidly isolate
the patient's right atrium from the inferior vena cava and the
superior vena cava when inflated; a vacuum lumen extending through
the elongated body from the distal end portion to the proximal end
portion and fluidly coupled to one or more distal fluid ports and
one or more proximal fluid ports in the distal end portion for
conducting blood from the patient's vena cava; and two balloon
lumens fluidly coupled to at least two balloon ports and arranged
parallel to the vacuum lumen within the elongated body, wherein one
of the balloon ports fluidly couples one of the balloon lumens to
the first balloon and another of the balloon ports fluidly couples
another of the balloon lumens to the second balloon for inflation
and deflation of the first balloon and the second balloon.
15. The multi-lumen cannula of claim 14, further comprising two
intermediate lumens fluidly coupled to one or more intermediate
fluid ports located in an intermediate region of the distal end
portion of the elongated body and arranged parallel to the vacuum
lumen within the elongated body.
16. The multi-lumen cannula of claim 14 or claim 15, further
comprising at least four additional vacuum lumens fluidly coupled
to at least one of the distal fluid ports or at least one of the
proximal fluid ports, or a combination thereof, and arranged
parallel to the vacuum lumen and located within the elongated
body.
17. A method, comprising: introducing a multi-lumen cannula into
the vena cava of a patient; inflating a first balloon of the
cannula within the inferior vena cava and a second balloon of the
cannula within the superior vena cava to fluidly isolate the right
atrium of the patient from the inferior vena cava or superior vena
cava; draining blood from the patent's inferior vena cava and
superior vena cava through at least one distal fluid port in the
cannula located distal to the first and second balloons and at
least one proximal fluid port in the cannula located proximal to
the first and second balloons; and conducting a fluid to or from
the right atrium through at least one intermediate fluid port in
the cannula located between the first balloon and the second
balloon.
18. The method of claim 17, wherein the first balloon and the
second balloon are inflated sequentially.
19. The method of claim 17, wherein the first balloon and the
second balloon are inflated simultaneously.
20. The method of any one of claims 17-19, wherein conducting a
fluid to or from the right atrium comprises delivering a
cardioplegia solution to the right atrium.
21. The method of any one of claims 17-19, wherein conducting a
fluid to or from the right atrium comprises delivering
re-oxygenated blood to the right atrium.
22. The method of any one of claims 17-21, wherein the multi-lumen
cannula is introduced into the patient's vena cava from an inferior
access point such that the first balloon is positioned proximal to
the second balloon.
23. The method of claim 22, wherein the inferior access point is in
the femoral vein.
24. The method of any one of claims 17-21, wherein the multi-lumen
cannula is introduced into the patient's vena cava from a superior
access point such that the first balloon is positioned proximal to
the second balloon.
25. The method of claim 24, wherein the superior access point is in
the internal jugular vein.
26. The method of any one of claims 17-25, wherein the distal fluid
ports, proximal fluid ports, and intermediate fluid ports drain
blood to a common blood reservoir.
27. The method of any one of claims 17-25, wherein the intermediate
ports drain blood to a first destination and the proximal fluid
ports and the distal fluid ports drain blood to a second
destination segregated from the first destination.
28. The method of claim 27, wherein the intermediate ports drain
blood to a cell saver for hemoconcentration and the proximal fluid
ports and distal fluid ports drain blood to a cardiotomy reservoir
for recirculation.
Description
FIELD
[0001] The present disclosure pertains to embodiments of
multi-lumen cannulae that can be used to facilitate heart repair
and/or other related procedures.
BACKGROUND
[0002] Surgically placed cannulae are frequently used in surgical
procedures to draw or push blood into patient vessels. In some
cases, multiple cannulae must be used during procedures. Current
cannulae known in the art are typically made from a single lumen
tube with multiple holes at the distal section. Such cannulae,
however, cannot perform multiple functions and thus multiple
cannulae are required to achieve such functions. As can be
appreciated, using multiple cannulae adds complexity to the
procedure, which can reduce efficiency and cause lengthy procedures
and thereby cause potential patient complications and/or result in
lengthy recovery times. Accordingly, a need exists in the art for a
single cannula that is capable of performing multiple different
functions during a procedure.
SUMMARY
[0003] The present disclosure concerns embodiments of multi-lumen
cannulae that can be used to facilitate multiple different
procedures during an operation, such as a heart operation, within a
patient's vasculature. The disclosed multi-lumen cannulae comprise
an elongated body having a distal end portion for placement in a
biological lumen of a patient and a proximal end portion for
placement outside the patient. The multi-lumen cannulae also may
have a first balloon and a second balloon connected to an exterior
surface of the elongated body in the distal end portion. The first
balloon and the second balloon can be configured to fluidly
isolate, between the first and second balloons, a portion of the
biological lumen of the patient when inflated. The multi-lumen
cannulae also comprise a central lumen extending through the
elongated body from the distal end portion to the proximal end
portion, distal fluid ports and proximal fluid ports in the distal
end portion of the elongated body that are fluidly coupled to the
central lumen for conducting fluid between the biological lumen of
the patient and the central lumen. The multi-lumen cannulae can
also comprise at least one balloon sidewall lumen arranged parallel
to the central lumen and located within an outer perimeter of the
elongated body, and at least one balloon port. The at least one
inflation and deflation port can fluidly couple the balloon
sidewall lumen to the first balloon, the second balloon, or both,
for inflation and deflation of the balloons. The multi-lumen
cannulae also can comprise at least one conduction sidewall lumen
and at least one intermediate fluid port located in an intermediate
region of the distal end portion of the elongated body.
[0004] An exemplary embodiment of a multi-lumen cannula can
comprise a first balloon sidewall lumen that is coupled to a first
inflation and deflation port and a second balloon sidewall lumen
that is coupled to a second inflation and deflation port. The
multi-lumen cannula also can comprise two conduction sidewall
lumens that are fluidly coupled to intermediate fluid ports. In
some embodiments, the multi-lumen cannula also can comprise at
least one conduction sidewall lumen that is fluidly coupled to at
least one distal fluid port, a proximal fluid port, or a
combination thereof. Distal fluid ports can be located in the
distal region of the distal end portion of the elongated body and
proximal fluid ports can be located in the proximal region of the
distal end portion of the elongated body.
[0005] An exemplary method of using a multi-lumen cannula such as
those disclosed herein comprises introducing a multi-lumen cannula
into the vena cava of a patient and inflating a first balloon of
the cannula within the inferior vena cava and a second balloon of
the cannula within the superior vena cava to fluidly isolate the
right atrium of the patient from the inferior vena cava or superior
vena cava. The method can further comprise draining blood from the
patent's inferior vena cava and superior vena cava through at least
one distal fluid port in the cannula located distal to the first
and second balloons and at least one proximal fluid port in the
cannula located proximal to the first and second balloons, and
conducting a fluid to or from the right atrium through at least one
intermediate fluid port in the cannula located between the first
balloon and the second balloon.
[0006] An exemplary embodiment of the method can involve
introducing the multi-lumen cannula into the patient's vena cava
from an inferior access point such that the first balloon is
positioned proximal to the second balloon, wherein the inferior
access point is in the femoral vein. In another embodiment, the
multi-lumen cannula can be introduced into the patient's vena cava
from a superior access point such that the first balloon is
positioned proximal to the second balloon, wherein the superior
access point is in internal jugular vein. The method also may
comprise using the distal fluid ports, proximal fluid ports, and
intermediate fluid ports to drain blood to a common blood
reservoir. In some embodiments, the intermediate ports can drain
blood to a first destination and the proximal fluid ports and the
distal fluid ports can drain blood to a second destination
segregated from the first destination. In exemplary embodiments,
the intermediate ports can drain blood to a cell saver for
hemoconcentration and the proximal fluid ports and distal fluid
ports can drain blood to a cardiotomy reservoir for
recirculation.
[0007] The foregoing and other objects, features, and advantages of
the disclosed technology will become more apparent from the
following detailed description, which proceeds with reference to
the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 shows a distal end portion of an exemplary
multi-lumen cannula.
[0009] FIG. 2 is cross-sectional view of an exemplary cannula body,
according to one embodiment, illustrating a central lumen and four
separate sidewall lumens.
[0010] FIG. 3 shows a distal end portion of another exemplary
multi-lumen cannula.
[0011] FIG. 4 is a cross-sectional view of an exemplary cannula
body, according to one embodiment, illustrating a central lumen and
three separate sidewall lumens.
[0012] FIG. 5 is a cross-sectional view of an exemplary cannula
body, according to one embodiment, illustrating a central lumen
fluidly coupled to ports formed within the cannula.
[0013] FIG. 6 is a cross-sectional view of an exemplary cannula
body comprising nine different sidewall lumens spaced around a
central lumen.
[0014] FIG. 7 shows a cannula body comprising two inflated
balloons.
[0015] FIG. 8 shows a proximal end portion of the multi-lumen
cannula of FIG. 1.
[0016] FIG. 9 shows an exemplary cannula handle that includes
various tubes connected to respective lumens of the multi-lumen
cannula.
[0017] FIG. 10 shows the dimensions of particular portions of the
distal end region of an exemplary multi-lumen cannula.
[0018] FIG. 11 shows a certain dimension of an exemplary sidewall
lumen.
[0019] FIG. 12 shows a certain dimension of another exemplary
sidewall lumen.
[0020] FIG. 13 shows an exemplary use of a multi-lumen cannula
wherein the balloons are not inflated and all of the ports and
lumens are used for common blood drainage.
[0021] FIG. 14 shows an exemplary use of a multi-lumen cannula
wherein the balloons are inflated, the ports in the distal region
and proximal region of the cannula are used to drain blood from the
SVC and the IVC, and ports in the intermediate region are used to
drain blood from the right atrium independent of the SVC and
IVC.
[0022] FIG. 15 shows an exemplary use of a multi-lumen cannula
wherein the balloons are inflated, ports in the distal region and
proximal region of the cannula are used to drain blood from the SVC
and the IVC, and no flow occurs through ports in the intermediate
region to or from the right atrium.
[0023] FIG. 16 shows an exemplary use of a multi-lumen cannula
wherein the balloons are inflated, the ports in the distal region
and proximal region of the cannula are used to drain blood from the
SVC and the IVC, and ports in the intermediate region are used to
infuse blood into the right atrium independent of the SVC and
IVC.
DETAILED DESCRIPTION
[0024] The present disclosure concerns embodiments of multi-lumen
cannulae that comprise multiple lumens capable of facilitating a
variety of different procedures that may be performed during a
heart valve operation and/or other medical procedure. The disclosed
multi-lumen cannulae can be used to conduct fluid into or out of
vessels during minimally invasive surgery or open heart surgeries.
Because the multi-lumen cannulae disclosed herein can comprise
multiple lumens within a single cannula body, additional separate
cannulae may not be necessary. The disclosed multi-lumen cannulae
can therefore provide more efficient means for providing
alternative blood flow routes during surgery as multiple different
cannulae may not need to be introduced and/or removed from the
patient, which can reduce physical stress to the patient and can
increase the speed of application of the cannulae.
[0025] The disclosed multi-lumen cannulae can also be used to
control and/or localize cardioplegia solution delivery to
particular sections of the heart, such as the right atrium, thereby
preventing mixing in undesired regions of the patients' circulatory
system. For example, in some embodiments, blood from the inferior
vena cava (referred to herein as "IVC") and the superior vena cava
(referred to herein as "SVC") can be isolated from the cardioplegia
solution as it is delivered to the patient's heart. The disclosed
multi-lumen cannulae also can be kink-resistant, and may not
require braided tubing or structure-reinforcing materials for
operation.
[0026] The examples provided below describe various features of the
disclosed multi-lumen cannulae as well as configurations of various
portions of the cannulae that can facilitate their use in medical
procedures, such as heart valve repairs (e.g., tricuspid valve
procedures, mitral valve repairs, or aortic valve repairs),
coronary artery bypass grafts, or extracorporeal membrane
oxygenation (ECMO) (e.g., veno-arterial ECMO or veno-venous ECMO).
Embodiments of the cannulae can be used for blood drainage, blood
delivery, and/or cardioplegia solution delivery during certain
procedures. These particular applications are intended to be
exemplary; the cannulae can also be used to facilitate other types
of heart procedures, non-heart related procedures, and/or patient
support.
[0027] FIG. 1 shows a multi-lumen cannula embodiment 100,
particularly a distal end portion 102 of the multi-lumen cannula,
which comprises elongated body or shaft having a distal region 104,
an intermediate region 106, and a proximal region 108. The distal
end portion 102 of the multi-lumen cannula 100 is understood herein
to be the end of the multi-lumen cannula inserted into the patient
during a procedure. In some embodiments, the distal end portion can
be inserted into a patient's vena cava. In some embodiments, the
distal end portion can be positioned within a patient's vena cava
so that the distal region of the distal end portion is positioned
within the IVC and the proximal region of the distal end portion is
positioned with the SVC, such as when the multi-lumen cannula is
introduced into the patient through the patient's internal jugular
vein. In other embodiments, the distal end portion can be
positioned within a patient's vena cava so that the distal region
of the distal end portion is positioned within the SVC and the
proximal region of the distal end portion is positioned within the
IVC, such as when the multi-lumen cannula is introduced into the
patient through the patient's femoral vein.
[0028] Blood can be conducted from a patient's vein to an external
reservoir through the multi-lumen cannula. The blood can be
conducted using passive or active conduction. Passive conduction is
understood herein to mean conducting blood through at least one
lumen of a multi-lumen cannula without applying an external vacuum
to facilitate flow. Active conduction is understood herein to mean
conducting blood through at least one lumen of a multi-lumen
cannula by applying an external vacuum.
[0029] As shown in FIG. 1, the distal region 104 of the distal end
portion 102 can comprise a tapered tip 110 that tapers to form
distal end 112, which can comprise one or more distal openings (not
illustrated) that can be coupled to a central lumen 144, which is
illustrated in FIG. 2. Any number of distal openings suitable for
facilitating fluid flow from the patient's vasculature into the
central lumen 144 can be included in the distal end 112, and the
distal openings can have any shape and configuration.
[0030] The distal region 104 can also comprise at least one distal
fluid port 114 (which can also be referred to as a side port) (FIG.
1), which can be fluidly coupled to the central lumen 144 (FIG. 2),
one or more sidewall lumens 152 (as illustrated in FIG. 2), or both
the central lumen and the one or more sidewall lumens. Any number
of distal fluid ports 114 can be included within the distal region
104 to conduct blood from the patient. For example, FIG. 1
illustrates a cannula embodiment wherein one or more distal fluid
ports 114, such as the two distal fluid ports shown in solid lines
in FIG. 1, can oppose one or more different distal fluid ports 114,
such as the two distal fluid ports shown in dashed lines in FIG. 1.
Including multiple distal fluid ports oriented around the perimeter
of the distal region 104 can facilitate fluid conduction through
the multi-lumen cannula. For example, the inclusion of a plurality
of distal fluid ports 114 around the distal region 104 increases
the surface area through which fluid can enter the cannula 100.
[0031] The distal fluid ports 114 can be formed by punching and/or
drilling holes in the exterior perimeter of the distal region 104
through to the central lumen 144 (FIG. 2) of the multi-lumen
cannula, through to one or more sidewall lumens (e.g., 152), and/or
through to one or more sidewall lumens and further from the
sidewall lumens through to the central lumen. In some embodiments,
the distal region 104 can comprise a single lumen tube. In such
embodiments, the distal fluid ports 114 can be fluidly coupled with
a single central lumen, which is the only lumen in the distal
region. Thus the distal fluid ports 114 can be located at any
position around the single lumen tube.
[0032] As illustrated in FIG. 1, the proximal region 108 of the
distal end portion 102 can also comprise a plurality of fluid
ports, such as proximal fluid side ports 115. Similar to the distal
fluid ports 114, proximal fluid side ports 115 can be fluidly
coupled to the central lumen 144 (FIG. 2), one or more sidewall
lumens, or combinations thereof. The sidewall lumens to which the
proximal fluid ports may be coupled may be the same as or different
from the sidewall lumens to which the distal fluid ports are
coupled. In some embodiments, the one or more sidewall lumens to
which the proximal fluid ports and/or the distal fluid ports are
fluidly coupled can be the conduction sidewall lumens 152
illustrated in FIG. 2. The proximal fluid ports 115 can be made
using the same technique described for the distal fluid ports. The
number and arrangement of proximal fluid ports can be the same as
or different from the number of distal fluid ports. In embodiments
where the proximal fluid ports 115 are coupled to the sidewall
lumen 152, the ports 115 can be arranged in an axially aligned
pattern (as shown in FIG. 1) that overlies the lumen 152.
[0033] The distal fluid ports 114, proximal fluid ports 115, or
combinations thereof can be configured to access blood flowing
within the patient's SVC and/or IVC and conduct the blood to an
external reservoir.
[0034] The distal fluid ports 114 and proximal fluid ports 115 can
be configured to have any shape and any arrangement within the
distal end portion 102 that is suitable for conducting blood from a
biological lumen to a central lumen and/or one or more sidewall
lumens. In some embodiments, the size, shape, and arrangement of
the distal fluid ports and the proximal fluid ports can be selected
to provide (or improve) a maximum flow requirement for a particular
procedure.
[0035] Multi-lumen cannulae embodiments disclosed herein also can
comprise one or more intermediate fluid ports positioned within an
intermediate region of the distal end portion of the cannula. Such
intermediate fluid ports can be used for a variety of purposes. In
some embodiments, the intermediate fluid ports can be used to
deliver a cardioplegia solution to a patient during an operation.
The intermediate fluid ports also can be utilized to conduct fluids
other than a cardioplegia solution (such as oxygenated blood,
deoxygenated blood, etc.) to and from the patient.
[0036] An exemplary embodiment of a multi-lumen cannula comprising
intermediate fluid ports is illustrated in FIG. 1. The distal end
portion 102 of multi-lumen cannula 100 can comprise intermediate
fluid side ports 124 positioned in the intermediate region 106 that
can facilitate flow into, or out of, one or more sidewall lumens
located in the sidewall of the multi-lumen cannula. In the
particular embodiment illustrated in FIG. 1, a plurality of
intermediate fluid ports 124 are arranged in two rows on one side
of the intermediate region. Such an arrangement can be used to
facilitate increased fluid flow to or from a particular target
location of the patient, such as the patient's right atrium.
[0037] As with the distal and proximal fluid ports 114, 115, any
size, shape, number, and/or arrangement of the intermediate fluid
ports 124 can be included. The size, shape, number, and/or
arrangement of the intermediate fluid ports can be selected
independent of the size, shape, number, and/or arrangement of the
distal and/or proximal fluid ports.
[0038] One or more of the intermediate fluid ports 124 can be
independently fluidly coupled to one of the two conduction sidewall
lumens 150 illustrated in FIG. 2, and the remaining intermediate
fluid ports 124 can be independently fluidly coupled to the other
conduction sidewall lumen 150.
[0039] The multi-lumen cannulae embodiments disclosed herein can
also comprise one or more balloons capable of being inflated and
deflated. In some embodiments, the balloons can be inflated to
facilitate a particular medical procedure. For example, the
balloons can be inflated to isolate the right atrium of the heart
from the IVC and the SVC. As illustrated in FIG. 1, balloons 116
and 118 can be positioned on the exterior surface of multi-lumen
cannula 100 within the distal end portion 102 of the multi-lumen
cannula. Balloon 116 can be positioned between the distal region
104 and intermediate region 106, and balloon 118 can be positioned
between the intermediate region and the proximal region 108.
[0040] FIG. 1 further illustrates balloon ports 120 and 122, which
can be positioned underneath balloons 116 and 118, respectively.
The balloon ports 120 and 122 can pass through the exterior
perimeter of the multi-lumen cannula 100 to at least one sidewall
lumen that runs parallel to the central lumen 144 (FIG. 2), such as
balloon sidewall lumen 148 (FIG. 2). Balloon ports 120 and 122 can
be used to conduct an inflation fluid (e.g., air, a saline
solution, or other liquid) to and from balloons 116 and 118 to
inflate and deflate the balloons during a procedure. FIG. 7
illustrates an embodiment of a multi-lumen cannula 700 comprising
two inflated balloons 702 and 704.
[0041] In some embodiments, a single sidewall lumen 148 can be
included to conduct an inflation fluid to and from both balloon
ports 120 and 122. Balloons 116 and 118 can therefore be inflated
and deflated at substantially the same time by conducting the
inflation fluid through the single balloon sidewall lumen 148 to
both balloon ports 120 and 122. In other embodiments, each balloon
can be coupled to an independent lumen such that each balloon can
be inflated or deflated at different times.
[0042] FIG. 2 is a cross-sectional view of the multi-lumen cannula
100 taken proximal to the proximal fluid ports 115. FIG. 2
illustrates a circumferential arrangement of the plurality of
sidewall lumens (e.g., conduction sidewall lumens 150 and 152 and
balloon sidewall lumen 148) with respect to the central lumen 144.
Referring to FIG. 2, the multi-lumen cannula 100 comprises an outer
perimeter 142 and an inner perimeter 146 surrounding the central
lumen 144. The outer perimeter 142 and an inner perimeter 146
define a sidewall 154 of the cannula 100 therebetween with the
lumens 148, 150, 152 being formed in the sidewall 154.
[0043] Another embodiment of the disclosed multi-lumen cannulae is
illustrated in FIGS. 3-5. As illustrated in FIG. 3, a distal end
portion 302 of multi-lumen cannula 300 comprises a distal region
304, an intermediate region 306, and a proximal region 308. The
distal region 304 can comprise a plurality of distal fluid ports
310, and the proximal region 308 of the distal end portion can
comprise a plurality of proximal fluid ports 311. The proximal
fluid ports 311 can be fluidly coupled to a common central lumen
332, as shown in FIG. 5. Similarly, the distal fluid ports 310 can
also be fluidly coupled to the central lumen 332.
[0044] FIG. 4 is a cross-section taken at a point proximal to the
proximal region 308. As illustrated in FIG. 4, a plurality of
different sidewall lumens 322, 324, and 326 can be
circumferentially positioned within sidewall 328 between the outer
perimeter 330 and inner perimeter 334. The sidewall lumens 322,
324, and 326 can run parallel to a central lumen 332.
[0045] FIG. 5 is another cross-sectional view of the multi-lumen
cannula 300 taken within the proximal region 308 of the distal end
portion 302. FIG. 5 illustrates how proximal fluid ports 311 are
fluidly coupled to central lumen 332. The proximal fluid ports 311,
as illustrated in FIG. 5, do not pass through sidewall lumens 322,
324, or 326, thereby segregating flow through the proximal fluid
ports to the central lumen 332 from flow through sidewall lumens
322, 324, and 326. The proximal fluid ports 311 can be arranged as
illustrated in FIG. 5 so that each proximal fluid port is
positioned between sidewall lumens 322, 324, and 326. As sidewall
lumens 322, 324, and 326 can terminate prior to entering the distal
region 304, the distal fluid ports 310 can be arranged in any
orientation independent of proximal fluid ports 311. In some
embodiments, however, the distal fluid ports can be arranged the
same as the proximal fluid ports.
[0046] As illustrated in FIG. 3, intermediate portion 306 comprises
a plurality of intermediate fluid ports 320. The intermediate fluid
ports 320 are fluidly coupled to sidewall lumen 326 and thus may be
placed along one side of the intermediate region 306 adjacent to
the sidewall lumen 326. The intermediate fluid ports 320 are
aligned in one row on one side of the multi-lumen cannula in this
particular embodiment; however, this illustration is exemplary and
in other embodiments, the intermediate fluid ports 320 can be
differently arranged. As discussed above, including the
intermediate ports 306 on one side of the multi-lumen cannula can
facilitate procedures wherein the right atrium of the patient is to
be isolated from blood flowing through a patient's vena cava. The
intermediate fluid ports 306 can be positioned to face the entrance
to the right atrium and facilitate fluid delivery specifically to
the right atrium.
[0047] Multi-lumen cannula 300, as illustrated in FIG. 3, can
further comprise two balloons 312 and 314 connected to the exterior
of the distal end portion 302. Balloon 312 covers balloon port 316
and balloon 314 covers balloon port 318. Each balloon port 316 and
318 can be independently fluidly coupled to a different sidewall
lumen. For example, balloon port 316 can be fluidly coupled to
sidewall lumen 322, which is illustrated in FIGS. 4 and 5, and
balloon port 318 can be fluidly coupled to sidewall lumen 324,
which is also illustrated in FIGS. 4 and 5. Using this
configuration, each balloon 312 and 314 can be connected to a
separate sidewall lumen thereby permitting selective inflation
and/or deflation of the balloons.
[0048] In some embodiments, the balloons can be inflated (and
ultimately deflated) sequentially to ensure that the balloon
positioned within the IVC is positioned in a suitable location
before the balloon positioned within the SVC is inflated. For
example, the balloon that is to be positioned within the IVC can be
positioned so that it blocks the right atrium from blood flowing
from the IVC to the right atrium. In some embodiments, the balloon
is positioned within the IVC so that the outer periphery of the
balloon sits approximately 4 cm from the inferior end of the right
atrium to avoid covering the patient's hepatic veins and thereby
prevent disrupted blood flow to the hepatic system. Alternatively,
the SVC balloon can be inflated before the IVC balloon.
[0049] In other procedures, the balloons 316, 318 can be inflated
(and ultimately deflated) simultaneously, or substantially
simultaneously. Simultaneous inflation can be accomplished by
administering an inflation fluid into the two independent sidewall
lumens 322, 330 at the same time, such as from a common source.
[0050] FIG. 6 is a cross-sectional view of another exemplary
multi-lumen cannula 600. Cannula 600 comprises a plurality of
sidewall lumens arranged circumferentially around a central lumen
610. The plurality of sidewall lumens can comprise, for example,
two independent sidewall lumens 602 coupled to intermediate ports
located in an intermediate region between two balloons, two
independent sidewall lumens 604 and 606 independently coupled to
the two balloons, and four sidewall lumens 608 coupled to distal
fluid ports, proximal fluid ports, or any combination thereof. The
sidewall lumens can be positioned substantially equidistant from
one another, or they can be positioned with an uneven spacing. Any
suitable arrangement can be chosen. Additionally, each sidewall
lumen can vary in size with respect to the other sidewall lumens,
and any number of sidewall lumens can be included.
[0051] The cannula can also comprise a proximal end portion
connected to, or continuing from the distal end portion. The
proximal end portion of the multi-lumen cannula can comprise a
handle portion suitable for manipulating/controlling flow through
the multi-lumen cannula. In some embodiments, the handle can be
used to deliver a fluid to the patient. For example, the
cardioplegia solution and/or the inflation fluid discussed above
can be delivered to the different intermediate fluid ports and/or
balloon ports disclosed herein via the corresponding conduction
sidewall lumens and/or balloon sidewall lumens that extend from the
proximal end portion of the elongated body to the distal end
portion of the elongated body. In some embodiments, the handle can
be used to facilitate oxygenated blood flow into the cannula from
an external heart/lung machine or other source during ECMO.
[0052] Exemplary embodiments of a handle that can be included with
a multi-lumen cannula are illustrated in FIGS. 8 and 9. As
illustrated in FIG. 8, the handle 128 can be positioned at the
proximal end portion 126 of multi-lumen cannula 100 and can
comprise two external delivery ports 130 and 132 that extend
outward from handle 128. These external delivery ports 130 and 132
can be connected to one or more delivery devices (not illustrated),
such as a delivery device or fluid source that provides a
cardioplegia solution, an inflation fluid, and/or blood to the
patient using multi-lumen cannula 100. The two external delivery
ports 130 and 132 can be arranged in any suitable configuration.
Additionally, any number of external delivery ports 130 and/or 132
can be attached to the handle.
[0053] One or more adaptor ridges 134 and tapered tip 136 can be
included in the proximal region 138 of the proximal end portion
126, as illustrated in FIG. 8. Tapered tip 136 and adaptor ridges
134 can facilitate connection to a vacuum device, which can
actively conduct fluid from the cannula through one or more
openings located in proximal end 140. In some embodiments, the
proximal region 138 of the proximal end portion 126 can comprise a
single lumen tube.
[0054] Another embodiment of a multi-lumen cannula comprising a
handle is illustrated in FIG. 9. Cannula 900 comprises a handle 902
including three delivery ports 904, 906, and 908, and a proximal
region 910.
[0055] The sidewall lumens of the multi-lumen cannula can terminate
at different axial locations along the cannula, independently of
the central lumen. For example, a sidewall lumen that is fluidly
coupled to an intermediate fluid port within an intermediate region
of the distal end portion can terminate within the intermediate
region so that it does not extend into a distal region. In some
embodiments, the distal region of the distal end portion can
comprise a single lumen tube. Sidewall lumens fluidly coupled to
balloon ports also can also be configured to terminate prior to the
distal region of the distal end portion of the cannula. Thus, the
number of lumens can decrease moving axially toward the distal end
of the cannula.
[0056] The multi-lumen cannulae disclosed herein can comprise a
variety of suitable materials, including polymers (e.g.,
polyurethane, nylon, polytetrafluoroethylene, polyvinylchloride,
and the like), metals (e.g., stainless steel or Ninitol), alloys,
composites, or combinations thereof. In certain embodiments, the
cannula can be extruded or wire wound. Extruded embodiments can be
sufficiently strong such that exterior support (such as a metal
coil) around the cannula may not be necessary. In some embodiments,
however, the cannula can be reinforced with a material that
promotes crush resistance, such as a coil or sheath.
[0057] The diameter of the elongated body of a multi-lumen cannula
can vary thereby affording different cannula embodiments that can
be used in differently sized patients and in different biological
lumens present in a patient's vasculature, such as the vena cava
(including the SVC and the IVC), the internal jugular vein, the
femoral vein, and the like. For example, the elongated body of a
multi-lumen cannula can have an outer diameter of about 0.2 inches
to about 0.4 inches, with some embodiments having an outer diameter
of about 0.27 inches to about 0.33 inches. The diameter of the
cannula can be larger in the regions of the elongated body that
include a handle or a balloon.
[0058] As the multi-lumen cannulae disclosed herein can be
introduced into the patient through the femoral vein or the
internal jugular vein or other vessels, the length of a particular
cannula can be selected to accommodate the particular biological
lumen into which it is to be placed.
[0059] In some embodiments, the elongated body can have a length of
about 55 cm to about 65 cm from the distal tip to the end of the
proximal region of the distal end portion. Such embodiments can be
used for a femoral approach. In other embodiments, the elongated
body can have a length of about 20 cm to about 45 cm from the
distal tip to the end of the proximal region of the distal end
portion. Such embodiments can be used for an internal jugular
approach.
[0060] Each of the distal region and the proximal region of the
distal end portion of the elongated body can have a length ranging
from about 3 cm to about 20 cm. Referring to FIG. 10 as an example,
the distal region can have a length 1000 ranging from about 3 cm to
about 20 cm as measured from the distal end of the cannula to the
distal end of the balloon positioned closest to the distal end of
the cannula. The proximal region can have a length 1002 ranging
from about 3 cm to about 20 cm as measured from the proximal end of
a proximal fluid port that is positioned closest to the proximal
end of the cannula to the proximal end of the balloon positioned
closest to the proximal end of the cannula.
[0061] In embodiments wherein a femoral approach is used, the
distal region of the distal end portion of the elongated body can
have a length 1000 ranging from about 3 cm to about 7 cm and the
proximal region of the distal end portion can have a length 1002
ranging from about 5 cm to about 20 cm. When a multi-lumen cannula
is inserted through an internal jugular vein of the patient, the
distal region of the distal end portion can have a length 1000 of
about 5 cm to about 20 cm, and the proximal region of the distal
end portion can have a length 1002 of about 3 cm to about 10
cm.
[0062] The balloons used with the disclosed multi-lumen cannulae
can be made of any suitable material, such as, but not limited to,
latex, silicone, polyethylene, polyurethane, or combinations
thereof. The outer surface of the balloons can be textured or
smooth. The balloons can be bonded to the exterior surface of the
cannulae using a suitable adhesive typically used in the art. The
balloons can be separated by a distance 1004 of about 5 cm to about
15 cm, as measured from the proximal end of the balloon positioned
closest to the distal end to the distal end of the balloon
positioned closest to the proximal end. In some embodiments, the
distance 1004 is about 14 cm. The balloons can have a length 1006
of up to about 2 cm, with some embodiments comprising balloons
having a length 1006 of about 1 cm.
[0063] Sidewall lumens can be formed within a multi-lumen cannula
by using a suitable extrusion method, for example. In particular
disclosed embodiments, the cross-sectional area of the sidewall
lumens can be maximized to facilitate actively conducting blood
and/or a fluid to and from the patient. The cross-sectional area of
the sidewall lumens also can be configured to minimize the amount
of cannula material present within the body of the multi-lumen
cannula so as to maximize the area of each sidewall lumen and/or
the central lumen.
[0064] Additionally, the distance or area between the sidewall
lumens and the outer perimeter of the cannula and/or the outer
perimeter of the central lumen can be minimized to facilitate use.
In some embodiments, a suitable distance or area between the
sidewall lumens and the outer perimeter of the cannula and/or the
outer perimeter of the central lumen is maintained to prevent, or
substantially prevent kinking of the cannula.
[0065] In different embodiments, any suitable spacing/positioning
can be used. The sidewall lumens also may have any shape and/or
size suitable for performing a desired function, such as
cardioplegia delivery, active or passive conduction, inflation
and/or deflation. In some embodiments, the sidewall lumens can be
oval-shaped and have a major diameter 1100, as illustrated in FIG.
11, of about 0.02 inches to about 0.04 inches, with some
embodiments having a major diameter 1100 of about 0.028 inches. In
other embodiments, the sidewall lumens can be crescent shaped
having a width 1200, as illustrated in FIG. 12, ranging from about
0.01 inches to about 0.020 inches, such as about 0.015 inches. The
sidewall lumens can be positioned to be about 0.01 inches from the
outer perimeter of the cannula body and about 0.01 inches from the
outer perimeter of the central lumen. The central lumen can have a
diameter of about 0.15 inches to about 0.3 inches. In exemplary
embodiments, the diameter of the central lumen can be about 0.2
inches to about 0.24 inches.
[0066] The disclosed multi-lumen cannulae can be used in various
different procedures. In some implementations, all or some of the
lumens and ports can be used for common blood drainage from the
vena cava and right atrium without inflating the balloons to
isolate the right atrium. FIG. 13 illustrates one such example. In
such implementations, lumens of the cannula (such as the central
lumen and one or more sidewall lumens) can be used to drain blood
from all ports to a common external reservoir. As illustrated in
FIG. 13, the multi-lumen cannula 1300 is positioned within a
patient's vena cava and blood flowing from the SVC (represented by
arrows 1302 and 1304) flows into a central lumen through distal end
1306 and also through distal fluid ports 1308 in the distal region
1310. Blood drained from the right atrium 1312 flows into the
cannula through intermediate ports 1314 in intermediate region
1316, such as into one or more of the sidewall lumens. Blood
flowing from the IVC 1318 can flow into the cannula through
proximal fluid ports 1320 of proximal region 1322, such as into the
central lumen or into one or more of the sidewall lumens. In the
embodiment illustrated in FIG. 13, balloons 1324 and 1326 are left
deflated such that the right atrium is not isolated from the SVC
and IVC. Thus, all of the ports and lumens are used for the same
purpose to drain blood from the vena cave and right atrium region.
This implementation of the multi-lumen cannula can be useful during
aortic valve repair, mitral valve repair, or other cardiac
procedures that do not require incision into the right portion of
the heart.
[0067] Another exemplary implementation of the multi-lumen cannula
1300 is illustrated in FIG. 14. In this embodiment, balloons 1324
and 1326 are inflated to isolate the right atrium from the SVC and
the IVC, and the blood drained from the right atrium can be
isolated from the blood drained from the SVC and the IVC. For
example, blood drained from the SVC (represented by arrows 1302 and
1304) and blood drained from the IVC (represented by arrows 1318)
can be conducted from the patient through a central lumen to a
first location, while blood flowing from the patient's right atrium
(represented by arrows 1312) can be conducted through one or more
sidewall lumens to a second location to segregate the blood.
[0068] In other implementations, the disclosed multi-lumen cannulae
can be used for cardioplegia delivery during a heart procedure. In
such implementations, the two balloons are inflated to isolate the
right atrium from the SVC and the IVC. The central lumen and/or one
or more of the sidewall lumens is used to drain blood from the SVC
and the IVC, such as to an external cardiotomy reservoir for
recirculation, while intermediate fluid ports of the cannula are
fluidly coupled to one or more sidewall lumens and selectively
drain blood from the right atrium to an external cell saver for
hemoconcentration. This selective drainage can occur when a
cardioplegia solution is being delivered to allow the cardioplegia
solution to be selectively removed from circulation. This use of
the intermediate ports and sidewall lumens can reduce the need for
hemoconcentration at a later stage in the operation thereby
reducing any negative impacts on the patient's blood chemistry.
Single- or multiple-dose cardioplegia can be delivered with the
disclosed multi-lumen cannulae.
[0069] The disclosed multi-lumen cannulae also can be used during a
procedure that requires incision into the right portion of the
heart, such as the right atrium (e.g., tricuspid valve repair). In
such embodiments, the multi-lumen cannulae can be manipulated to
facilitate the procedure by stopping flow through the sidewall
lumens in communication with the ports in the intermediate region
between the two balloons such that no fluid is conducted into or
out of the right atrium. Blood can then be drained from the SVC and
the IVC through the central lumen and/or sidewall lumens without
effecting the right atrium. The surgeon may then optionally snare
around the right atrium prior to performing the desired right-heart
procedure. FIG. 15 illustrates an exemplary implementation of the
multi-lumen cannula 1300 for blood drainage during a right-heart
surgical procedure, such as a tricuspid valve repair. Balloons 1324
and 1326 are inflated to isolate the patient's right atrium from
the SVC and the IVC. Blood flowing from the SVC (represented by
arrows 1302) is conducted through a central lumen through distal
end 1306 and distal fluid ports 1308 located in distal region 1310.
Blood flowing from the IVC (represented by arrows 1318) is
conducted from the patient through proximal fluid ports 1320
located in proximal region 1322 into the central lumen and/or one
or more sidewall lumens.
[0070] In other implementations, the disclosed multi-lumen cannulae
can be used in an ECMO procedure, such as veno-arterial ECMO. In
some implementations, the central lumen and optionally one or more
of the sidewall lumens can be used to facilitate blood drainage
from the SVC and the IVC, while one or more of the sidewall lumens
are used to re-infuse oxygenated blood into the right atrium from
an external source, such as a heart/lung machine. The re-infused
blood can be introduced into the right atrium through intermediate
ports positioned between the two balloons of the cannula. In such
embodiments, the balloons need not be inflated; however, the
balloons of the multi-lumen cannulae can be inflated to avoid
mixing oxygenated and deoxygenated blood, thereby improving the
oxygen saturation of blood being delivered to the right atrium.
FIG. 16 illustrates an exemplary implementation use multi-lumen
cannula 1300 to drain deoxygenated blood from the SVC and the IVC
while re-infusing oxygenated blood into the right atrium. Blood
flowing from the patient's SVC (represented by arrows 1302 and
1304) is conducted through distal end 1306 and through distal fluid
ports 1308 of distal region 1310. Blood flowing from the IVC
(represented by arrows 1318) is conducted into the cannula through
proximal fluid ports 1320. Balloons 1324 and 1326 are inflated in
FIG. 16 to isolate the right atrium. Intermediate fluid ports 1314
in the intermediate region 1316 are fluidly coupled to one or more
sidewall lumens and selectively deliver oxygenated blood into the
right atrium.
[0071] For purposes of this description, certain aspects,
advantages, and novel features of the embodiments of this
disclosure are described herein. The disclosed methods,
apparatuses, and systems should not be construed as limiting in any
way. Instead, the present disclosure is directed toward all novel
and nonobvious features and aspects of the various disclosed
embodiments, alone and in various combinations and sub-combinations
with one another. The methods, apparatuses, and systems are not
limited to any specific aspect or feature or combination thereof,
nor do the disclosed embodiments require that any one or more
specific advantages be present or problems be solved.
[0072] Features, integers, characteristics, compounds, chemical
moieties or groups described in conjunction with a particular
aspect, embodiment or example of the invention are to be understood
to be applicable to any other aspect, embodiment or example
described herein unless incompatible therewith. All of the features
disclosed in this specification (including any accompanying claims,
abstract and drawings), and/or all of the steps of any method or
process so disclosed, may be combined in any combination, except
combinations where at least some of such features and/or steps are
mutually exclusive. The invention is not restricted to the details
of any foregoing embodiments. The invention extends to any novel
one, or any novel combination, of the features disclosed in this
specification (including any accompanying claims, abstract and
drawings), or to any novel one, or any novel combination, of the
steps of any method or process so disclosed.
[0073] Although the operations of some of the disclosed methods are
described in a particular, sequential order for convenient
presentation, it should be understood that this manner of
description encompasses rearrangement, unless a particular ordering
is required by specific language. For example, operations described
sequentially may in some cases be rearranged or performed
concurrently. Moreover, for the sake of simplicity, the attached
figures may not show the various ways in which the disclosed
methods can be used in conjunction with other methods. As used
herein, the terms "a", "an", and "at least one" encompass one or
more of the specified element. That is, if two of a particular
element are present, one of these elements is also present and thus
"an" element is present. The terms "a plurality of" and "plural"
mean two or more of the specified element.
[0074] As used herein, the term "and/or" used between the last two
of a list of elements means any one or more of the listed elements.
For example, the phrase "A, B, and/or C" means "A", "B,", "C", "A
and B", "A and C", "B and C", or "A, B, and C."
[0075] As used herein, the term "coupled" generally means
physically, chemically, electrically, magnetically, or otherwise
coupled or linked and does not exclude the presence of intermediate
elements between the coupled items absent specific contrary
language.
[0076] In view of the many possible embodiments to which the
principles of the disclosed technology may be applied, it should be
recognized that the illustrated embodiments are only preferred
examples of the disclosed technology and should not be taken as
limiting the scope of the technology. Rather, the scope of the
disclosed technology is at least as broad as the following claims.
We therefore claim all that comes within the scope of these
claims.
* * * * *