U.S. patent application number 10/797363 was filed with the patent office on 2004-09-02 for double-y-shaped multi-lumen catheter with selectively attachable hubs.
Invention is credited to Boyd, Ronald D., Cassidy, Kenneth T., Fleming, Carl M., Fleming, Gary S., Wilson, Jon S..
Application Number | 20040171997 10/797363 |
Document ID | / |
Family ID | 32044828 |
Filed Date | 2004-09-02 |
United States Patent
Application |
20040171997 |
Kind Code |
A1 |
Wilson, Jon S. ; et
al. |
September 2, 2004 |
Double-y-shaped multi-lumen catheter with selectively attachable
hubs
Abstract
A multi-lumen catheter and method for inserting same in a
patient is disclosed. The catheter includes an elongated, central,
multi-lumen tube portion having a proximal end and a distal end.
The central tube portion has a substantially cylindrical outer
shape and is internally segmented into a plurality of lumens. A
distal branch portion includes a plurality of single-lumen distal
extension tubes. Each distal extension tube has a proximal first
end and a distal second end. The proximal first end of each distal
extension tube is connected to the distal end of the central tube
portion such that the single lumen of each distal extension tube is
in fluid communication with one of the plurality of lumens of the
central tube portion. A proximal branch portion includes a
plurality of single-lumen proximal extension tubes. Each proximal
extension tube has a distal first end and a proximal second end.
The distal first end of each proximal extension tube is connected
to the proximal end of the central tube portion such that the
single lumen of each distal extension tube is in fluid
communication with one of the plurality of lumens of the central
tube portion. Each lumen of the central tube portion and the lumens
of the distal and proximal extension tubes in fluid communication
therewith define a flow path through the catheter. Selectively
attachable hub connectors are provided for selective attachment to
the distal extension tubes and connection of the catheter to a
fluid exchange device.
Inventors: |
Wilson, Jon S.;
(Winston-Salem, NC) ; Fleming, Carl M.; (Stuart,
FL) ; Cassidy, Kenneth T.; (Mocksville, NC) ;
Boyd, Ronald D.; (Statesboro, GA) ; Fleming, Gary
S.; (Palm City, FL) |
Correspondence
Address: |
Michael P. Kenney
Amster, Rothstein & Ebenstein
21th Floor
90 Park Avenue
New York
NY
10016
US
|
Family ID: |
32044828 |
Appl. No.: |
10/797363 |
Filed: |
March 10, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10797363 |
Mar 10, 2004 |
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10231748 |
Aug 30, 2002 |
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10231748 |
Aug 30, 2002 |
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10086033 |
Feb 28, 2002 |
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6638242 |
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10086033 |
Feb 28, 2002 |
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09769052 |
Jan 24, 2001 |
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Current U.S.
Class: |
604/284 |
Current CPC
Class: |
A61M 1/3659 20140204;
A61M 2025/0037 20130101; A61M 25/0029 20130101; A61M 25/0097
20130101; A61M 1/3661 20140204; A61M 1/3653 20130101; A61M
2025/0034 20130101; A61M 2025/0098 20130101; A61M 2025/0031
20130101; A61M 1/16 20130101 |
Class at
Publication: |
604/284 |
International
Class: |
A61M 025/00 |
Claims
What is claimed is:
1. A multi-lumen catheter comprising: (a) a central, elongated,
multi-lumen tube portion having a proximal end and a distal end,
the central tube portion having a substantially cylindrical outer
shape and being internally segmented into a plurality of lumens;
(b) a distal branch portion comprising a plurality of single-lumen
distal extension tubes, each distal extension tube having a
proximal first end and a distal second end, the proximal first end
of each distal extension tube being permanently connected to the
distal end of the central tube portion such that the single lumen
of each distal extension tube is in fluid communication with one of
the plurality of lumens of the central tube portion; (c) a proximal
branch portion comprising a plurality of single-lumen proximal
extension tubes, each proximal extension tube having a distal first
end and a proximal second end, the distal first end of each
proximal extension tube being permanently connected to the proximal
end of the central tube portion such that the single lumen of each
distal extension tube is in fluid communication with one of the
plurality of lumens of the central tube portion; and (d) a
plurality of selectively attachable connector hubs, each connector
hub being configured to be selectively attachable to the distal
second end of one of the distal extension and being configured for
selective connection to a fluid exchange device; wherein each lumen
of the central tube portion and the lumens of the distal and
proximal extension tubes in fluid communication therewith define a
flow path through the catheter.
2. A multi-lumen catheter according to claim 1, wherein the central
tube portion includes two lumens, the distal branch portion
includes two distal extension tubes, and the proximal branch
portion includes two proximal extension tubes.
3. A multi-lumen catheter according to claim 1 wherein the
plurality of single-lumen distal extension tubes of the distal
branch portion converge to form a distal multi-lumen connecting
portion which connects to the distal end of the central tube
portion, and the plurality of single-lumen proximal extension tubes
comprising the proximal branch portion converge to form a proximal
multi-lumen connecting portion which connects to the proximal end
of the central tube portion.
4. A multi-lumen catheter according to claim 1 wherein the central
tube portion, the distal extension tubes, and the proximal
extension tubes are comprised of a fusible material, and the distal
extension tubes and proximal extension tubes are respectively fused
to the distal and proximal ends of the central tube portion.
5. A multi-lumen catheter according to claim 1 wherein the distal
extension tubes have a substantially cylindrical outer shape near
their distal second ends.
6. A multi-lumen catheter according to claim 3 wherein the proximal
extension tubes have a substantially D-shaped cross-section over at
least a portion of their length.
7. A multi-lumen catheter according to claim 3 wherein the proximal
multi-lumen connecting portion has a substantially cylindrical
outer shape.
8. A multi-lumen catheter according to claim 1 wherein the proximal
extension tubes are substantially parallel to each other in a free
state.
9. A multi-lumen catheter according to claim 1 wherein the at least
one of the proximal extension tubes is shorter in length than at
least one other proximal extension tube.
10. A multi-lumen catheter according to claim 1 further including a
stabilizing cuff affixed to an outer portion of the central tube
portion.
11. A multi-lumen catheter according to claim 1 wherein the
proximal end of each selectively attachable connector hub includes
a tube portion configured to be sealably inserted into a portion of
a lumen at the distal second end of one of the distal extension
tubes.
12. A multi-lumen catheter according to claim 11 wherein the tube
portion of each connector hub includes at least one outer
circumferential step, barb, or ridge for releasably gripping a
portion of a distal extension tube into which the tube portion is
inserted.
13. A multi-lumen catheter according to claim 1, wherein each of
the proximal extension tubes includes a tube wall, and each of the
proximal extension tubes includes at least one opening extending
through its tube wall.
14. A multi-lumen catheter according to claim 1, wherein an
external portion of at least one of the distal extension tubes
includes indicia, the indicia indicating a discrete flow path
through the catheter.
15. A multi-lumen catheter according to claim 2 wherein the two
proximal extension tubes have longitudinal axes which intersect at
an included angle in a free state, the included angle being in a
range from about 10 degrees to about 30 degrees.
16. A y-shaped catheter junction comprising: (a) a dual-lumen trunk
having a substantially cylindrical outer wall, a first end, a
second end, a first lumen, and a second lumen; (b) a first
single-lumen extension tube connected to the first end of the
trunk, wherein the single lumen of the first single-lumen extension
tube is in fluid communication with the first lumen of the trunk;
and (c) a second single-lumen extension tube connected to the first
end of the trunk, wherein the single lumen of the second
single-lumen extension tube is in fluid communication with the
second lumen of the trunk; wherein the first lumen of the trunk and
the first extension tube define a first flow path, and the second
lumen of the trunk and the second extension tube define a second
flow path.
17. A y-shaped catheter junction according to claim 16 wherein the
first and second extension tubes have longitudinal axes which
intersect at an included angle near a first end of the trunk in a
free state, the included angle being in a range from about 10
degrees to about 30 degrees.
18. A method of forming a multi-lumen catheter, the method
comprising permanently attaching a first plurality of single-lumen
extension tubes to a distal end of a length of multi-lumen tubing
comprising a plurality of multiple lumens, and permanently
attaching a second plurality of single-lumen extension tubes to a
distal end of the length of multi-lumen tubing, wherein each single
lumen of each extension tube is in fluid communication with one of
the lumens of the length of multi-lumen tubing.
19. A method according to claim 18, wherein the length of
multi-lumen tubing includes two lumens, and the first and second
pluralities of extension tubes form substantially y-shaped
junctions on each end of the length of multi-lumen tubing.
20. A method of forming a multi-lumen catheter according to claim
19, the method comprising: (a) forming a y-shaped distal junction
including: (i) providing a first length of single-lumen tubing to
form a distal arterial extension tube; (ii) providing a second
length of single-lumen tubing to form a distal venal extension
tube; (iii) providing a first length of multi-lumen tubing
comprising at least an arterial lumen and a venal lumen, and having
a distal end and a proximal end; (iv) permanently attaching an end
of the distal arterial extension tube to the distal end of the
first length of multi-lumen tubing such that the distal arterial
extension tube is in fluid communication with the arterial lumen of
the first length of multi-lumen tubing; and (v) permanently
attacking an end of the distal venal extension tube to the distal
end of the first length of multi-lumen tubing such that the distal
venal extension tube is in fluid communication with the venal lumen
of the first length of multi-lumen tubing; wherein the proximal end
of the first length of multi-lumen tubing forms a connecting end;
(b) providing a second length of multi-lumen tubing having a distal
end and a proximal end, and having an arterial lumen and a venal
lumen, and permanently attaching the connecting end to the distal
end of the second length of multi-lumen tubing, such that the
arterial extension tube of the distal junction is in fluid
communication with the arterial lumen of the second length of
multi-lumen tubing, and the venal extension tube of the distal
junction is in fluid communication with the venal lumen of the
second length of multi-lumen tubing; (c) forming a y-shaped
proximal junction including: (i) providing a third length of
single-lumen tubing to form a proximal arterial extension tube;
(ii) providing a fourth length of single-lumen tubing to form a
proximal venal extension tube; (iii) providing a third length of
multi-lumen tubing comprising at least an arterial lumen and a
venal lumen, and having a distal end and a proximal end; (iv)
permanently attaching an end of the proximal arterial extension
tube to the distal end of the third length of multi-lumen tubing
such that the proximal arterial extension tube is in fluid
communication with the arterial lumen of the third length of
multi-lumen tubing; and (v) permanently attaching an end of the
proximal venal extension tube to the distal end of the third length
of multi-lumen tubing such that the proximal venal extension tube
is in fluid communication with the venal lumen of the third length
of multi-lumen tubing; wherein the distal end of the third length
of multi-lumen tubing forms an attachment end; and (d) permanently
attaching the attachment end to the proximal end of the second
length of multi-lumen tubing, such that the arterial extension tube
of the proximal junction is in fluid communication with the
arterial lumen of the second length of multi-lumen tubing, and the
venal extension tube of the proximal junction is in fluid
communication with the venal lumen of the second length of
multi-lumen tubing;
21. A method according to claim 20, the method further comprising
forming at least one opening in a wall of the proximal venal
extension tube, and forming at least one opening in a wall of the
arterial proximal extension tube.
22. A method according to claim 20 wherein permanently attaching
extension tubes and lengths of multi-lumen tubing together or to
each other comprises fusing ends of the tubes or tubing
together.
23. The method of claim 19, wherein the longitudinal axes of the
distal arterial extension tube and the distal venal extension tube
intersect at an included angle in a free state, the included angle
being in a range from about 10 degrees to about 30 degrees.
24. A method for surgically implanting a double-y shaped
multi-lumen catheter tube into a patient, the multi-lumen catheter
including an elongated, central, multi-lumen tube portion, a
proximal end portion including a single-lumen proximal venal
extension tube and a single-lumen proximal arterial extension tube
each having a proximal tip, and a distal end portion including a
single-lumen distal venal extension tube and a single-lumen distal
arterial extension tube each having a distal end, the method
comprising: (a) making an incision in the skin of the patient (b)
inserting the proximal tips of the proximal venal and arterial
extension tubes through the incision and placing the proximal tips
in the patient; (c) forming a subcutaneous tunnel having a first
end proximate to the incision and a second end remote from the
first end of the tunnel; (d) guiding the distal venal and arterial
extension tubes and at least a portion of the central tube portion
through the subcutaneous tunnel such that at least the distal ends
of the distal venal and arterial extension tubes extend outwardly
from the tunnel through the second end of the tunnel; and (e)
securing at least a portion of the distal end portion of the
catheter to the patient.
25. A method according to claim 24, the method further comprising
respectively connecting the distal arterial and venal extension
tubes to arterial and venal legs of a fluid exchange device.
26. A method according to claim 25, wherein connecting the distal
arterial and venal extension tubes to arterial and venal legs of a
fluid exchange device comprises connecting the distal arterial
extension tube to the arterial leg with a first connector hub, and
connecting the proximal venal extension tubes to the venal leg with
a second connector hub.
26. The method of claim 23, wherein inserting the proximal tips of
the proximal venal and arterial extension tubes into a patient
comprises: placing the proximal tip of the venal extension tube
into a vein in the patient; and placing the proximal tip of the
arterial extension tube into an artery in the patient.
28. The method of claim 24 wherein the central tube portion further
includes a stabilizing cuff affixed to an outer portion of the
central tube portion, the method further comprising dilating at
least a portion of the subcutaneous tunnel before guiding the
distal venal and arterial extension tubes and at least a portion of
the central tube portion through the subcutaneous tunnel, wherein
the dilating step comprises sliding a sheath dilator along a shaft
of a trocar longitudinally positioned in the tunnel.
29. The method of claim 28 wherein securing at least a portion of
the distal end portion of the catheter to the patient comprises
seating the stabilizing cuff in a dilated portion of the
subcutaneous tunnel.
30. The method of claim 24 wherein guiding the distal venal and
arterial extension tubes and at least a portion of the central tube
portion through the subcutaneous tunnel comprises: (a) inserting a
trocar through the subcutaneous tunnel such that an insertion tip
of the trocar protrudes from the first end of the tunnel; (b)
connecting the distal ends of the distal venal and arterial
extension tubes to a proximal end of a connector; (c) connecting a
proximal end of the connector to the protruding insertion tip of
the trocar; and (d) guiding the distal venal and arterial extension
tubes and at least a portion of the central tube portion through
the subcutaneous tunnel with the trocar.
31. The method of claim 30 further comprising placing a sheath
having a smooth outer contour over the connector and at least
portions of the venal and arterial extension tubes before guiding
the distal venal and arterial extension tubes and at least a
portion of the central tube portion through the subcutaneous tunnel
with the trocar.
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of pending U.S.
patent application Ser. No. 10/086,033, filed Feb. 28, 2002, which
is a continuation of pending U.S. patent Application Ser. No.
09/769,052, filed Jan. 24, 2001.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical
instrumentation and more specifically to a multi-lumen catheter
including y-shaped distal and proximal ends, and including
selectively attachable hubs for selectively connecting the catheter
to a fluid exchange device.
[0004] 2. Description of the Prior Art
[0005] Catheters, generally, are hollow, flexible tubes for
insertion into a body cavity, duct, or vessel to allow the passage
of fluids or distend a passageway. Catheters are often used for
temporary or long-term dialysis treatment. Dialysis treatment
provides for blood to be withdrawn from the patient, purified, and
then returned to the patient. Thus, in dialysis treatment,
catheters are used to allow passage of a patient's blood into and
out of the patient's body. For optimal performance during dialysis
treatment, the catheter tips, both in-flow and out-flow, should be
placed in close proximity to the heart. Typically, medical
personnel use either a double lumen catheter or two single lumen
catheters. Both types, however, present certain deficiencies.
[0006] While double lumen catheters (e.g., U.S. Pat. No. 4,895,561)
allow for a single insertion of the catheter into the desired vein,
double lumen catheters typically do not permit optimal catheter tip
placement. Due to differences among patients, optimal tip position
varies from patient to patient. Non-optimal tip position may
significantly lower flow values, resulting in less effective
dialysis treatment. For current double lumen catheters, a physician
must make an estimate regarding the appropriate catheter tube
length prior to beginning the procedure of catheterization. Then, a
subcutaneous tunnel is made from a first end, which is near the
area to be catheterized, to a second end, which is the preferred
end position of the hub assembly, namely, away from the neck of the
patient, in order to allow for more convenient access to the
dialysis treatment equipment. The catheter tube is then routed
forwardly into the through the subcutaneous tunnel from the second
end to the first end so that the catheter tips extend outwardly
from the first end of the tunnel. Either before or after tunneling,
a sheath is inserted trough the first end of the tunnel and into
the area to be catheterized, and the catheter tips are inserted
into the sheath and the area to be catheterized. The estimated
catheter tube length and subsequent forward tunneling may result in
less than optimal tip placement.
[0007] With the use of two independent single lumen catheters
(e.g., U.S. Pat. No. 5,776,111 to Tesio) the problem of tip
placement is addressed. The hub assembly of each catheter is
removable from the tube and tip portion of the catheter, thereby
allowing the catheter tip to be placed directly into the vein and
advanced into the desired position. Then, the proximal end of the
catheter can be reversed tunneled and trimmed to a desired length.
Thereafter, the hub assembly is attached. Deficiencies, however,
exist in this method of catheterization as well. One problem
associated with this method is that this method requires two
separate venous insertions, namely, two tunnels and two of each
accessory instrument used for the procedure. Therefore, there is
increased surgical time required to place two catheters, there are
two wound entry sites which doubles the risk of post-surgical
infection, and the two catheters together are significantly larger
in diameter than one double lumen catheter.
[0008] Applicant's co-pending application Ser. No. 09/769,052,
filed Jan. 24, 2001, and Ser. No. 10/086,033, filed Feb. 28, 2002,
disclose a multi-lumen catheter apparatus and method for inserting
the apparatus in a patient. The disclosures of these co-pending
applications are hereby incorporated by reference. In the disclosed
apparatus and method, a multi-lumen catheter includes a selectively
attachable hub assembly that allows the catheter tip to be
positioned accurately within a patient's vein prior to subcutaneous
tunneling. The distal end of the catheter tube is selectively
attachable to the hub assembly. Accordingly, after the tips of the
catheter have been accurately positioned in a patient, the other
end of the catheter may be reverse tunneled under the skin of a
patient. Before or after tip placement, an incision is made in the
skin adjacent to the point where the protruding distal end of the
catheter exits the skin. A subcutaneous tunnel is then formed
having a first end at the incision and a second end exiting the
skin at a point remote from the first end of the tunnel, generally
as the caudal direction. A sheath dilator is inserted into the
tunnel, which is partially dilated so as to accommodate a tissue
in-growth stabilizing cuff. The distal end of the catheter tube is
routed through the subcutaneous tunnel and the cuff seated therein,
thereby stabilizing the distal portion of the catheter tube in the
patient. A selectively attachable hub assembly is connected to the
lumens at the distal tip of the catheter tube for subsequent
connection of the catheter to a fluid exchange device, such as a
dialysis machine.
[0009] While the selectively attachable hub assembly described
above facilitates tunneling a multi-lumen catheter in a patient,
the separable hub assembly creates the need to connect the hub to a
distal end of a multi-lumen catheter tube, thereby adding an
additional step to the catheter insertion/connection procedure,
which increases surgical time and expense. Furthermore, the
hub-catheter connection provides an additional connection which may
leak or separate from the catheter tube due to external loads on
the hub such as by pulling or snagging. In addition, the attachable
hub assembly is a relatively complex part, which makes it difficult
to manufacture and, therefore, use of the hub assembly increases
the cost of the catheter itself.
[0010] Therefore, there is a need for a multi-lumen catheter that
can be inserted into a patient using a reverse tunneling technique,
which permits accurate placement of the tips of the catheter into
the area to be catheterized and that is selectively attachable to a
fluid exchange device. The improved catheter should not required an
extensive hub assembly, thus making it relatively inexpensive to
manufacture and easy to insert into a patient.
SUMMARY OF THE INVENTION
[0011] A multi-lumen catheter is provided for use in hemodialysis
and the like. The multi-lumen catheter includes an elongated,
central, multi-lumen tube portion having a distal end and a
proximal end. The central tube portion has a substantially
cylindrical outer shape and is internally segmented into a
plurality of lumens. A distal branch portion includes a plurality
of single-lumen distal extension tubes. Each distal extension tube
has a proximal first end and a distal second end. The proximal
first end of each distal extension tube is connected to the distal
end of the central tube portion such that the single lumen of each
distal extension tube is in fluid communication with one of the
plurality of lumens of the central tube portion. A proximal branch
portion includes a plurality of single-lumen proximal extension
tubes. Each proximal extension tube has a distal first end and a
proximal second end. The distal first end of each proximal
extension tube is connected to the proximal end of the central tube
portion such that the single lumen of each distal extension tube is
in fluid communication with one of the plurality of lumens of the
central tube portion. A plurality of selectively attachable
connector hubs are provided, each connector hub being configured to
be selectively attachable to the distal second end of one of the
distal extension and being configured for selective connection to a
fluid exchange device. Each lumen of the central tube portion and
the lumens of the distal and proximal extension tubes in fluid
communication therewith define a flow path through the catheter. An
in-growth stabilizing cuff may be affixed to an outer portion of
the central tube portion.
[0012] The multi-lumen catheter may include a central tube portion
having two lumens. In such a catheter, the distal branch portion
includes two distal extension tubes, and the proximal branch
portion includes two proximal extension tubes. The catheter may be
arranged such that the plurality of single-lumen distal extension
tubes of the distal branch portion converge to form a distal
multi-lumen connecting portion which connects to the distal end of
the central tube portion, and the plurality of single-lumen
proximal extension tubes comprising the proximal branch portion
converge to form a proximal multi-lumen connecting portion which
connects to the proximal end of the central tube portion.
[0013] The central tube portion, the distal extension tubes, and
the proximal extension tubes may be comprised of a fusible
material, and the distal extension tubes and proximal extension
tubes may be respectively fused to the distal and proximal ends of
the central tube portion. The distal extension tubes may have a
substantially cylindrical outer shape near their distal second
ends, and the proximal multi-lumen connecting portion may also have
substantially cylindrical outer shape. The proximal extension tubes
may have a substantially D-shaped cross-section over at least a
portion of their length. Also, the proximal extension tubes may be
substantially parallel to each other in a free state, and the
proximal second ends of the distal extension tubes may be
longitudinally spaced from each other.
[0014] The multi-lumen catheter may further include a plurality of
connector hubs for connecting the catheter to a fluid exchange
device. Each connector hub may configured to be connected to the
distal second end of one of the distal extension tubes, and
configured for connection to a portion of a fluid exchange
apparatus. Each of the proximal extension tubes may include a tube
wall, and each of the proximal extension tubes may include at least
one opening extending through its tube wall. Further, an external
portion of at least one of the distal extension tubes may include
indicia which indicates a discrete flow path through the catheter.
In one arrangement, the two proximal extension tubes have
longitudinal axes which intersect at an included angle in a free
state, the included angle being in a range from about 10 degrees to
about 30 degrees.
[0015] A y-shaped catheter junction for a multi-lumen catheter is
also provided. The y-shaped junction includes a dual-lumen trunk,
having a substantially cylindrical outer wall, a first end, a
second end, a first lumen, and a second lumen. A first single-lumen
extension tube is connected to the first end of the trunk, such
that the single lumen of the first single-lumen extension tube is
in fluid communication with the first lumen of the trunk. A second
single-lumen extension tube is connected to the first end of the
trunk such that the single lumen of the second single-lumen
extension tube is in fluid communication with the second lumen of
the trunk. The y-shaped junction is arranged such that the first
lumen of the trunk and the first extension tube define a first flow
path, and the second lumen of the trunk and the second extension
tube define a second flow path. The y-shaped catheter junction may
also be arranged such that the first and second extension tubes
have longitudinal axes which intersect at an included angle near
the first end of the trunk in a free state; the included angle
being in a range from about 10 degrees to about 30 degrees.
[0016] A method of forming a multi-lumen catheter is also
disclosed. The method includes attaching a first plurality of
single-lumen extension tubes to a distal end of a length of
multi-lumen tubing comprising a plurality of multiple lumens, and
attaching a second plurality of single-lumen extension tubes to a
distal end of the length of multi-lumen tubing. Each single lumen
of each extension tube is in fluid communication with one of the
lumens of the length of multi-lumen tubing. The length of
multi-lumen tubing may include two lumens, and the first and second
pluralities of extension tubes may form substantially y-shaped
junctions on each end of the length of multi-lumen tubing.
[0017] The method of forming a multi-lumen catheter may include
first forming a y-shaped distal junction. The process may include
providing a first length of single-lumen tubing to form a distal
arterial extension tube, providing a second length of single-lumen
tubing to form a distal venal extension tube, providing a first
length of multi-lumen tubing comprising at least an arterial lumen
and a venal lumen, and having a distal end and a proximal end,
attaching an end of the distal arterial extension tube to the
distal end of the first length of multi-lumen tubing such that the
distal arterial extension tube is in fluid communication with the
arterial lumen of the first length of multi-lumen tubing, and
attaching an end of the distal venal extension tube to the distal
end of the first length of multi-lumen tubing such that the distal
venal extension tube is in fluid communication with the venal lumen
of the first length of multi-lumen tubing. The proximal end of the
first length of multi-lumen tubing forms a connecting end.
[0018] A second length of multi-lumen tubing having a distal end
and a proximal end is provided. The tubing includes an arterial
lumen and a venal lumen. The connecting end of the first length of
multi-lumen tubing is connected to the distal end of the second
length of multi-lumen tubing, such that the arterial extension tube
of the distal junction is in fluid communication with the arterial
lumen of the second length of multi-lumen tubing, and the venal
extension tube of the distal junction is in fluid communication
with the venal lumen of the second length of multi-lumen
tubing.
[0019] A y-shaped proximal junction is also formed. This process
includes providing a third length of single-lumen tubing to form a
proximal arterial extension tube, and providing a fourth length of
single-lumen tubing to form a proximal venal extension tube. A
third length of multi-lumen tubing is also provided which includes
at least an arterial lumen and a venal lumen, and has a distal end
and a proximal end. An end of the proximal arterial extension tube
is attached to the distal end of the third length of multi-lumen
tubing such that the proximal arterial extension tube is in fluid
communication with the arterial lumen of the third length of
multi-lumen tubing. Also, an end of the proximal venal extension
tube is attached to the distal end of the third length of
multi-lumen tubing such that the proximal venal extension tube is
in fluid communication with the venal lumen of the third length of
multi-lumen tubing. The distal end of the third length of
multi-lumen tubing forms an attachment end.
[0020] The attachment end of the third length of multi-lumen tubing
is attached to the proximal end of the second length of multi-lumen
tubing, such that the arterial extension tube of the proximal
junction is in fluid communication with the arterial lumen of the
second length of multi-lumen tubing, and the venal extension tube
of the proximal junction is in fluid communication with the venal
lumen of the second length of multi-lumen tubing. The method may
also include forming at least one opening in a wall of the proximal
venal extension tube, and forming at least one opening in a wall of
the arterial proximal extension tube. The steps of attaching
extension tubes and lengths of multi-lumen tubing together or to
each other may include heat welding or similar fusing techniques.
The longitudinal axes of the distal arterial extension tube and
distal venal extension tube may be arranged to intersect at an
included angle in a free state in a range from about 10 degrees to
about 30 degrees.
[0021] A method for surgically implanting a double-y shaped
multi-lumen catheter into a patient is also provided. The method is
suited for implanting a multi-lumen catheter having a an elongated,
central, multi-lumen tube portion, a proximal end portion including
a single-lumen proximal venal extension tube and a single-lumen
proximal arterial extension tube each having a proximal tip, and a
distal end portion including a single-lumen distal venal extension
tube and a single-lumen distal arterial extension tube each having
a distal end. The method includes making an incision in the skin of
the patient, and inserting the proximal tips of the proximal venal
and arterial extension tubes through the incision and placing the
proximal tips in the patient. A subcutaneous tunnel is formed
having a first end proximate to the incision and a second end
remote from the first end of the tunnel. The distal venal and
arterial extension tubes and at least a portion of the central tube
portion are guided through the subcutaneous tunnel such that at
least the distal ends of the distal venal and arterial extension
tubes extend outwardly from the tunnel through the second end of
the tunnel. At least a portion of the distal end portion of the
catheter is secured to the patient such as by sutures or any other
suitable means.
[0022] When the catheter includes a stabilizing cuff, the method
may further include dilating at least a portion of the subcutaneous
tunnel to receive the cuff. Dilation of the tunnel may be
accomplished by sliding a sheath dilator along the shaft of a
trocar longitudinally positioned within the tunnel. The distal end
portion of the catheter is secured to the patient by seating the
cuff in a dilated portion of the subcutaneous tunnel.
[0023] The catheter implanting method may further include
respectively connecting the distal arterial and venal extension
tubes to arterial and venal legs of a fluid exchange device.
Connecting the distal arterial and venal extension tubes may
include connecting the distal arterial extension tube to the
arterial leg with a first connector hub, and connecting the
proximal venal extension tubes to the venal leg with a second
connector hub. Inserting the proximal tips of the proximal venal
and arterial extension tubes into a patient may include placing the
proximal tip of the venal extension tube into a vein in the
patient, and placing the proximal tip of the arterial extension
tube into an artery in the patient.
[0024] These and other aspects of the invention will be made clear
from a reading the following detailed description together with the
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a perspective view of a double y-shaped
multi-lumen catheter;
[0026] FIG. 2 is a cross-sectional view of a distal portion of the
multi-lumen catheter of FIG. 1;
[0027] FIG. 3 is a partially exploded detail perspective view of a
distal portion of the multi-lumen catheter of FIG. 1;
[0028] FIG. 4 is a partially exploded detail perspective view of a
proximal portion of the multi-lumen catheter of FIG. 1;
[0029] FIG. 5 is a cross-sectional view of a proximal portion of
the multi-lumen catheter of FIG. 1;
[0030] FIGS. 6A-6D illustrate a procedure for tunneling a
multi-lumen catheter like that of FIG. 1 in a patient;
[0031] FIG. 7 is a partial sectional view of a sheath dilator
engaged along a trocar to dilate a portion of a subcutaneous tunnel
in a patient;
[0032] FIGS. 8A-8C are views of a connection between a distal end
of the catheter and a trocar for guiding the catheter through a
subcutaneous tunnel.
DETAILED DESCRIPTION
[0033] For the purposes of the following description and the claims
appended hereto, the relative term "proximal" refers to those
portions of a catheter and those portions of components of the
catheter which are nearest the insertion end of the catheter, that
is, the end of the catheter that is inserted into an area of a
patient's body being catheterized, such as a blood vessel.
Conversely, the relative term "distal" refers to those portions of
a catheter and those portions of components of the catheter which
are farthest from the insertion end of the catheter.
[0034] FIG. 1 shows a double-Y shaped multi-lumen catheter 10
according to the present invention. The catheter 10 includes a
proximal end 34 for insertion into a patient, and a distal end 36
for connection to a fluid exchange device, such as a dialysis
machine or the like. The catheter 10 includes an elongated,
central, multi-lumen tube portion 12, a plurality of proximal
single-lumen extension tubes 14, 16, and a plurality of distal
single-lumen extension tubes 18, 20. In the embodiment shown, the
central tube portion 12 includes an arterial lumen 5 and a venal
lumen 6. In this arrangement, the catheter 10 includes a proximal
venal extension tube 14 and a distal venal extension tube 18 in
fluid communication with the venal lumen 6, and a proximal arterial
extension tube 16 and a distal arterial extension tube in fluid
communication with the arterial lumen 5. The catheter 10 may
include a stabilizing cuff 15 affixed to an outer portion of the
central tube portion 12 as shown in FIG. 1. Preferably, the cuff 15
is longitudinally positioned on the central tube portion 12 such
that the cuff 15 will be finally positioned in a subcutaneous
tunnel in a patient as described more fully below.
[0035] A construction for the distal end 36 of the multi-lumen
catheter 10 is shown in FIGS. 1-3. As shown in FIGS. 2 and 3, the
proximal ends 18p, 20p of the distal extension tubes 18, 20 may be
connected to a distal end 12d of the central tube portion 12 by a
distal multi-lumen trunk 30. The multiple lumens of the distal
trunk 30 correspond in number to the multiple lumens of the central
tube portion 12 and the number of distal extension tubes 18, 20. In
the illustrated embodiment, the distal trunk 30 includes a venal
distal trunk lumen 48, and an arterial distal trunk lumen 47 as
shown in FIG. 2. As shown in FIG. 3, the proximal ends 18p, 20p of
the distal extension tubes 18, 20 are connected to the distal end
30d of the distal trunk, thereby forming a substantially Y-shaped
junction. The proximal end 30p of the distal trunk 30 is connected
to the distal end 12d of the central tube portion 12 as shown in
FIG. 2, thereby forming a Y-shaped distal end 36. Preferably, the
proximal end 30p of the distal trunk 30 is substantially
cylindrical in shape, and is substantially equal in outer diameter
to the outer diameter of the central tube portion 12, thereby
providing a smooth transition at the juncture between the distal
trunk 30 and the central tube portion 12.
[0036] As shown in FIG. 2, the distal extension tubes are arranged
such that an included angle ".theta." exists between the
longitudinal axes of the tubes 18, 20 in a free state. In a
preferred arrangement, the angle ".theta." ranges from about 10
degrees to about 30 degrees. The distal extension tubes 18, 20 can
be arranged, however, so that the angle ".theta." is any desired
angle. The venal distal trunk lumen 48 is in fluid communication
with the venal lumen 6 of the central tube portion 12 and the
single lumen of the distal venal extension tube 18. Similarly, the
arterial distal trunk lumen 47 is in fluid communication with the
arterial lumen 5 of the and the single lumen of the distal arterial
extension tube 20.
[0037] In an alternative arrangement, the distal extension tubes
18, 20 may be connected directly to the distal end 12d of the
central tube portion 12 rather than to an interconnected distal
trunk 30 (not shown). In either arrangement, the mating end
portions of the distal extension tubes 18, 20, the distal end of
the central tube portion 12d, and/or the distal trunk 30 are
sealably fused together by heat welding or the like such that the
fluid communication between the interconnecting lumens of the
components is established and maintained and no leakage occurs at
the connections.
[0038] As shown in FIGS. 1-3, the catheter 10 also includes
selectively attachable connector hubs 72, 74 on the distal ends
18d, 20d of the distal extension tubes 18, 20. As will be described
in detail below, the connector hubs 72, 74 are selectively
attachable so that the connector hubs 72, 74 can be attached to and
removed from the distal end 36 of the catheter 10 after insertion
of the proximal end 34 of the catheter 10 into a patient, and after
reverse, subcutaneous tunneling of the distal end 36. As shown in
FIGS. 1 and 2, the connector hubs 72, 74 are configured for
selective sealable attachment between the distal ends 18d, 20d of
the distal extension tubes 18, 20 and legs of a fluid exchange
device. The connector hubs. The venal connector hub 74 is
selectively attachable to the distal portion 18d of the distal
venal extension tube 18, and the arterial connector hub 72 is
selectively attachable to the distal portion 20d of the distal
arterial extension tube 20.
[0039] In one embodient as shown in FIGS. 1-3, the selectively
attachable hubs 72, 74 are connectable with mating compression
fittings 58, 60. The compression fittings may include cannulae 66,
68 and threaded male portions 62, 64 that matingly engage the
distal extension tubes 18, 20 and the connector hubs 72, 74 as
shown in FIG. 2. When fully engaged, the hubs 72,74 and compression
fittings 58, 60 compress compression sleeves 70 about the distal
portions 18d, 20d of the distal extension tubes 18, 20, thereby
forming sealed connections. The compression fittings 58, 60 may be
further connected to luer-type fittings 50, 52 or the like by
connector tubes 54, 56. The luer-type fittings 50, 52 may then be
connected to corresponding luer-type connection mechanisms on a
fluid exchange device 200. For example, the distal ends of the
luer-type fittings 50, 52 may include quarter-turn type threads for
leak-tight engagement with matching quarter-turn fittings on the
venal and arterial legs of a fluid exchange device 200. Other types
of known leak-tight selectively attachable connection
configurations may also be used.
[0040] As shown in FIGS. 1 and 3, the connector hubs 72, 74 can be
selectively attached to the distal ends 18d, 20d of the distal
extension tubes 18, 20. This arrangement permits the distal end 36
of the catheter 10 to be subcutaneously reverse tunneled in a
patient as described more fully below without interference from the
hubs 72, 74. After the distal end of the catheter 10 is
subcutaneously reverse tunneled in a patient such that the distal
end 36 protrudes outwardly from the patient, the hubs 72, 74 can be
backfit over the distal ends of distal extension tubes 18, 20 as
shown for hub 72 in FIG. 3. The compression sleeves 70 can then be
placed over the distal ends 18d, 20d of the extension tubes 18, 20,
and the sealed connections can be completed as shown in FIG. 2. The
catheter 10 can then be connected to a fluid exchange device
200.
[0041] A construction for the proximal end 34 of the catheter 10 is
shown in FIGS. 1, 4, and 5. The distal ends 14d, 16d of the
proximal extension tubes 14,16 may be connected to a proximal end
12p of the central tube portion 12 by a proximal multi-lumen trunk
32. The lumens of the proximal trunk 32 correspond in number to the
multiple lumens of the central tube portion 12 and to the number of
proximal extension tubes 14, 16. In the illustrated embodiment, the
proximal trunk 32 includes a venal proximal trunk lumen 31, and an
arterial proximal trunk lumen 33 as shown in FIG. 5. As shown in
FIG. 4, the distal ends 14d, 16d of the proximal extension tubes
14, 16 are connected to the proximal end 32p of the proximal trunk
32, thereby forming a substantially Y-shaped junction. The distal
end 32d of the proximal trunk 32 is connected to the proximal end
12p of the central tube portion 12 as shown in FIG. 5, thereby
forming a substantially Y-shaped proximal end 34 on the catheter
10. Preferably, the distal end 32d of the proximal trunk 32 is
substantially cylindrical in shape, and is substantially equal in
outer diameter to the outer diameter of the central tube portion
12, thereby providing a smooth transition at the juncture between
the proximal trunk 32 and the central tube portion 12.
[0042] As shown in FIG. 4, the proximal extension tubes are
arranged such that an included angle ".alpha." exists between the
longitudinal axes of the tubes 14, 16 in a free state. In a
preferred arrangement, the angle ".alpha." is about 5 degrees in a
rest position or free state. The distal extension tubes 18, 20 can
be arranged, however, so that the angle ".alpha." is any desired
angle. The venal proximal trunk lumen 31 is in fluid communication
with the venal lumen 6 of the central tube portion 12 and the
single lumen of the proximal venal extension tube 14. Similarly,
the arterial proximal trunk lumen 33 is in fluid communication with
the arterial lumen 5 of the central tube portion 12 and the single
lumen of the proximal arterial extension tube 16.
[0043] In an alternative arrangement, the proximal extension tubes
14, 16 may be connected directly to the proximal end 12p of the
central tube portion 12 rather than to an interconnecting proximal
trunk 32 (not shown). In either arrangement, the mating end
portions of the proximal extension tubes 14, 16, the proximal end
of the central tube portion 12p, and/or the proximal trunk 32 are
sealably fused together, such as by heat welding or the like, such
that the fluid communication between the interconnected lumens of
the components is established and maintained and no leakage occurs
at the connections.
[0044] As shown in FIGS. 1, 4, and 5, the proximal arterial
extension tube 16 is preferably shorter in length than the proximal
venal extension tube 14. For example, the proximal arterial
extension tube 16 may be about 4 cm shorter in length than the
proximal venal extension tube 14. The resulting longitudinal
spacing between the proximal tips 14p and 16p facilitates optimal
proximal tip placement in a patient. As shown in FIG. 4, the
proximal venal extension tube 14 may include an end opening 43 in
or near its proximal tip 14p. The proximal venal extension tube 14
may also include one or more transverse openings 42 in its tube
wall 40. Similarly, as also shown in FIG. 4, the proximal arterial
extension tube 16 may include an end opening 47 in or near its
proximal tip 16p. The proximal arterial extension tube 16 may also
include one or more transverse openings 46 in its tube wall 44. The
openings 42, 43, 46, and 47 facilitate fluid flow into or out from
the proximal extension tubes 14, 16.
[0045] The hubs 72 and 74 are selectively attachable and detachable
from the distal end 36 of the catheter 10 to facilitate tunneling
the catheter 10 in a patient. A method of installing a catheter 10
in a patient is illustrated in FIGS. 6A-6D. As shown in FIG. 6A, an
incision 100 is made in the skin of a patient. The proximal tips
14p, 16p of catheter 10 are inserted through the incision 100 and
are placed at desired locations within the patient using
conventional techniques, such as the Seldinger technique.
[0046] At this stage, the distal end 36 and distal portions of the
catheter 10 extend outwardly from the incision 100. A trocar 120 or
other suitable instrument is used to form a subcutaneous tunnel 102
having a first end 104, which is preferably coincident with the
incision 100, and an opposed second end 106, which is remote from
the first end 104, as shown in FIG. 6A.
[0047] As shown in FIG. 6B, the distal end 36 of the catheter 10 is
inserted through the first end 104 of the tunnel 102, and the
distal end 36 is guided through the tunnel 102 such that the distal
end 36 extends out from the tunnel 102 at its second end 106. The
distal extension tubes 18, 20 are sufficiently flexible that they
may be bundled or clamped together by any suitable means to
facilitate passing the Y-shaped distal end 36 of the catheter 10
through the tunnel 102.
[0048] In a preferred arrangement as shown in FIGS. 8A and 8B, the
distal ends 18d, 20d of the distal extension tubes 18, 20 are
attached to a connector 300. The proximal end of the connector 300
may include a first tip 302 and a second tip 304 as shown. The tips
302, 304 are insertable into the lumens at the distal ends 18d, 20d
of the distal extension tubes 18, 20. The tips 302, 304 preferably
include ribs 301 or the like to tightly engage within the distal
ends 18d, 20d of the distal extension tubes 18, 20 such that the
connector 300 is securely but removably attached to the extension
tubes 18, 20. When the tips 302, 304 are respectively engaged in
the distal extension tubes 18, 20, the connector 300 holds the
distal extension tubes 18, 20 in close arrangement as shown so that
the distal extension tubes 18, 20 can be simultaneously
subcutaneously tunneled in a patient as described below. The distal
end of the connector 300d preferably includes a bore 306 which is
configured to attachably receive an insertion tip 308 of the trocar
120. The bore 306 may include threads 310 which can be engaged with
mating threads 312 on the insertion tip 308 of the trocar 120.
Alternatively, the bore 306 may include a collar portion 314 which
snaps into a groove 309 on the insertion tip 308 of the trocar 120
as shown in FIG. 8C. In this way, the distal end 300d of the
connector 300 can be engaged on the insertion tip 308 of the trocar
120 to route the attached distal extension tubes 18, 20 through the
subcutaneous tunnel 102 with the trocar 120. Once the distal end 36
of the catheter 10 has been drawn through the tunnel 102, the
connector 300 can be disengaged from the distal extension tubes 18,
20.
[0049] In order to provide the distal portions of the catheter 10
with a smooth and compact outer profile to facilitate passage of
the distal end 36 of the catheter 10 through the tunnel 102, a
sheath 320 may be used as shown in FIG. 8B. The sheath 320 is
placed over at least a portion of the connector 300 and the distal
extension tubes 18, 20. Preferably, the distal end 320d of the
sheath 320 is tapered as shown. The sheath 320 and the distal
portions of the catheter 10 can be drawn together through the
tunnel 102 with the trocar 120. The sheath 320 is removed from the
catheter 10 once the distal portions of the catheter 10 have been
drawn through the tunnel 102.
[0050] As shown in FIG. 6C, the distal end 36 of the catheter 10 is
drawn from the second end 104 of the tunnel 102 such that the
distal extension tubes 18, 20 and at least a portion of the central
tube portion 12 extends from the second end 104 and the catheter 10
is fully tunneled in the patient. The incision 100 and the second
end 104 of the tunnel are suitably treated and dressed.
[0051] An outer portion of the central tube portion 12 may include
a tissue in-growth stabilizing cuff 15, as shown in FIG. 1, for
stabilizing the inserted catheter 10 in the patient. Referring to
FIGS. 6C and 7, when the catheter 10 includes a stabilizing cuff
15, a portion 130 of tunnel 102 may be dilated to enlarge the width
of the tunnel 102 to receive the cuff 15 as the catheter 10 is
drawn through the tunnel 102. As shown in FIG. 7, the dilated
portion 130 of the tunnel is preferably dilated by sliding a sheath
dilator 200 over an end 42 and shaft 41 of the trocar 120 when the
trocar 120 is positioned in the subcutaneous tunnel 102 as shown in
FIG. 6A. The sheath dilator 200 preferably includes a hollow bore
208, a tapered leading end 206, a substantially cylindrical portion
204, and a handle 202. The sheath dilator 200 is inserted through
the first end 104 of the tunnel 102 and into the tunnel 102 until
the tip 206 has been inserted proximate to a cuff seating point 140
in the tunnel 102 to form a dilated portion 130 of the tunnel 102.
Once the dilated portion 130 is sufficiently dilated, the sheath
dilator 200 is removed from the tunnel 102 and the trocar 120. The
catheter 10 is finally positioned in the tunnel 102 when the cuff
15 is seated near an end 140 of the dilated portion 130 of the
tunnel 102 as shown in FIG. 6C.
[0052] As shown in FIG. 6D, the catheter 10 is connected to a fluid
exchange device 200. The distal end 18d of the distal venal
extension tube 18 is selectively attached to a venal leg 224 of the
fluid exchange device 200 by connector hub 74. Similarly, the
distal end 20d of the distal arterial extension tube 20 is
selectively attached to an arterial leg 222 of the fluid exchange
device 200 by connector hub 72. As shown in FIG. 3, indicia 26 and
28 may be included on the distal extension tubes 18, 20 and/or the
connector hubs 72, 74 to assist medical personnel in identifying
the proper distal extension tube 18 or 20 for connection to a
corresponding leg of the fluid exchange device 300. The indicia 26,
28 may be markings, colors, or any other distinctive indicator.
[0053] While this invention has been illustrated and described in
accordance with a preferred embodiment, it is recognized that
variations and changes may be made therein without departing from
the invention as set forth in the claims. Certain modifications and
improvements will occur to those skilled in the art upon a reading
of the forgoing description. For example, while the multi-lumen
catheter has been described with reference to a catheter with two
lumens, the invention also includes multi-lumen catheters including
three or more lumens as required. It should be understood that all
such modifications are not contained herein for the sake of
conciseness and readability, but are properly within the scope of
the following claims.
* * * * *