U.S. patent application number 10/789181 was filed with the patent office on 2004-08-26 for multiple lumen access device having a multifunction adapter and method of use.
Invention is credited to Bobo, Donald E. JR., Bulman, Erik E., Higgins, Michael J., Miraki, Manouchehr A., Mooney, Charles R., Pecor, Robert, Willoughby, Gary R..
Application Number | 20040167478 10/789181 |
Document ID | / |
Family ID | 32872689 |
Filed Date | 2004-08-26 |
United States Patent
Application |
20040167478 |
Kind Code |
A1 |
Mooney, Charles R. ; et
al. |
August 26, 2004 |
Multiple lumen access device having a multifunction adapter and
method of use
Abstract
A multiple lumen access device for use in providing a single
entry port into the human body for selectively introducing medical
implements therethrough and for providing simultaneous auxiliary
access into the body. The multiple lumen access device includes a
multi-lumen sheath which may have an outer tube and structure
defining a device lumen located therein. The inner structure may be
an inner wall or inner tube. The outer tube and inner structure are
located so as to define at least one auxiliary lumen. Some
embodiments include flexible inner walls which can be flexed
between relaxed and expanded/contracted positions wherein the
relative cross-sectional areas of the device lumen and auxiliary
lumens are varied. The access device further includes a valve which
provides sealing of the device lumen. The valve may be provided in
a lumen junction housing or separate from the housing either
permanently or removably connected with the device lumen.
Alternatively, a multi-lumen sheath may be passed through a valve
leading to a conventional introducer. The valve may also be molded
separately as a rigid insert and retained in a cavity formed in a
flexible junction housing. In other embodiments, the multiple lumen
access device is formed by introduction of the elongated implement
coaxially within a tubular single lumen sheath.
Inventors: |
Mooney, Charles R.; (Costa
Mesa, CA) ; Pecor, Robert; (Aliso Viejo, CA) ;
Bobo, Donald E. JR.; (Santa Ana, CA) ; Higgins,
Michael J.; (Trabuco Canyon, CA) ; Miraki, Manouchehr
A.; (Laguna Hills, CA) ; Bulman, Erik E.;
(Mission Viejo, CA) ; Willoughby, Gary R.; (Castle
Rock, CO) |
Correspondence
Address: |
Edwards Lifesciences LLC
Legal Dept.
One Edwards Way
Irvine
CA
92614
US
|
Family ID: |
32872689 |
Appl. No.: |
10/789181 |
Filed: |
February 26, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10789181 |
Feb 26, 2004 |
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09329002 |
Jun 8, 1999 |
|
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09329002 |
Jun 8, 1999 |
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08953105 |
Oct 17, 1997 |
|
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08953105 |
Oct 17, 1997 |
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08756763 |
Nov 26, 1996 |
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Current U.S.
Class: |
604/264 |
Current CPC
Class: |
A61B 17/3439 20130101;
A61M 2025/0036 20130101; A61B 17/3417 20130101; A61B 17/3498
20130101; A61M 25/0097 20130101; A61M 25/0032 20130101; A61M
25/0668 20130101; A61M 25/0075 20130101; A61M 2025/0025 20130101;
A61M 2025/0034 20130101; A61B 2017/3445 20130101; A61M 25/0023
20130101; A61M 2025/0035 20130101 |
Class at
Publication: |
604/264 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. A multiple lumen access device for medical uses comprising: an
infusion introducer having an access tube with a proximal end and a
distal end for introduction into the body, the introducer including
a hub connected to the proximal end of the access tube and a
hemostasis valve in a fixed location within the hub that provides a
seal around medical implements that are introduced and withdrawn to
and from the body through an access tube lumen, the introducer
further including a side arm opening distally with respect to the
hemostasis valve for infusing a medical solution to the access tube
lumen; a catheter including a catheter tube and a junction housing
on a proximal end of the catheter tube, the junction housing having
a proximal end and a distal end and including a main channel and at
least one auxiliary channel separate from the main channel, both
the main channel and the auxiliary channel being in fluid
communication with at least one lumen defined in the catheter tube;
and a multi-function adapter having a first unit and a
complementary second unit for coupling the catheter to the hub of
the infusion introducer such that the catheter tube passes through
the hemostasis valve into the access tube lumen, the first unit
being attached to the junction housing, and the second unit being
fixedly attached to the hub, wherein the first unit may be
removably connected to the second unit such that the introducer is
converted from an infusion introducer to a multiple lumen access
device by virtue of the main channel and the auxiliary channel in
the junction housing.
2. The access device of claim 1 wherein both the main channel and
the auxiliary channel extending from the proximal to the distal end
of the junction housing, and the main channel and auxiliary channel
diverge from the distal end of the junction housing to the proximal
end of the junction housing.
3. The access device of claim 1 wherein the catheter tube includes
multiple lumens, one each in fluid communication with the main
channel and the auxiliary channel, respectively.
4. The access device of claim 1 wherein the multi-function adapter
comprises at least one channel on the first unit and a
complementary outwardly extending lug on the second unit for
engaging the channel.
5. The access device of claim 4 wherein the multi-function adapter
comprises two L-shaped channels on the first unit and two outwardly
extending lugs on the second unit for engaging the L-shaped
channels.
6. The access device of claim 1 wherein the multi-function adapter
for coupling the junction housing comprises complementary luer
threads on the first and second units.
7. The access device of claim 1 wherein the junction housing
includes a device valve therein, the device valve being positioned
to provide a seal around devices passed into the main channel.
8. The access device of claim 7 further including a valve insert
housing the device valve and the junction housing includes a cavity
open to the main channel for receiving the valve insert.
9. The access device of claim 1 wherein the first unit of the
multi-function adapter has a through bore that fits over and is
secured to the exterior of the catheter tube.
10. The access device of claim 1 wherein the first unit of the
multi-function adapter is rigidly fixed on the distal end of the
junction housing.
11. The access device of claim 1 wherein the catheter tube has a
length sufficient to extend distally from the distal end of the
access tube when the catheter is coupled to the hub of the infusion
introducer.
12. The access device of claim 11 wherein the catheter is a central
venous catheter.
13. The access device of claim 1 wherein a distal end of the
catheter tube terminates in the access tube lumen when the catheter
is coupled to the hub of the infusion introducer.
14. The access device of claim 1 further including a small diameter
catheter tube connected to the auxiliary channel of the
multi-function adapter, the small catheter tube forming an infusion
lumen while a space between the small catheter tube and the access
tube lumen defines a device lumen.
15. A multiple lumen access device for medical uses comprising: an
infusion introducer having an access tube with a proximal end and a
distal end for introduction into the body, the introducer including
a hub connected to the proximal end of the access tube and a
hemostasis valve in a fixed location within the hub that provides a
seal around medical implements that are introduced and withdrawn to
and from the body through an access tube lumen, the introducer
further including a side arm opening distally with respect to the
hemostasis valve for infusing a medical solution to the access tube
lumen; a catheter including a catheter tube and a junction housing
on a proximal end of the catheter tube, the junction housing having
a proximal end and a distal end and including a main channel and at
least one auxiliary channel separate from the main channel, both
the main channel and the auxiliary channel being in fluid
communication with at least one lumen defined in the catheter tube;
and a multi-function adapter having a first unit and a
complementary second unit for coupling the catheter to the hub of
the infusion introducer such that the catheter tube passes through
the hemostasis valve and into the access tube lumen, the first unit
being rigidly attached to the junction housing and having two
L-shaped channels, and the second unit being rigidly attached to
the hub and having two outwardly extending lugs for engaging the
L-shaped channels, wherein the first unit may be removably
connected to the second unit with the lugs in the L-shaped channels
such that the introducer is converted from an infusion introducer
to a multiple lumen access device by virtue of the main channel and
the auxiliary channel in the junction housing.
16. The access device of claim 15 wherein both the main channel and
the auxiliary channel extending from the proximal to the distal end
of the junction housing, and the main channel and auxiliary channel
diverge from the distal end of the junction housing to the proximal
end of the junction housing.
17. The access device claim 15 wherein the junction housing
includes a device valve therein, the device valve being positioned
to provide a seal around devices passed into the main channel.
18. The access device of claim 17 further including a valve insert
housing the device valve and the junction housing includes a cavity
open to the main channel for receiving the valve insert.
19. The access device of claim 15 wherein the catheter tube has a
length sufficient to extend distally from the distal end of the
access tube when the catheter is coupled to the hub of the infusion
introducer.
20. The access device of claim 19 wherein the catheter is a central
venous catheter.
21. The access device of claim 15 wherein a distal end of the
catheter tube terminates in the access tube lumen when the catheter
is coupled to the hub of the infusion introducer.
22. A method for selectively introducing medical devices and
infusing a medical solution into a human body through a single
entry port, comprising: inserting an infusion introducer to the
vasculature, the infusion introducer having an access tube with a
proximal end and a distal end, and a hub connected to the proximal
end of the access tube, wherein a hemostasis valve in a fixed
location within the hub provides a seal around medical implements
that are introduced and withdrawn to and from the body through an
access tube lumen, the introducer further including a side arm
opening distally with respect to the hemostasis valve for infusing
a medical solution to the access tube lumen; providing a catheter
including a catheter tube and a junction housing on a proximal end
of the catheter tube, the junction housing having a proximal end
and a distal end and a main channel and at least one auxiliary
channel separate from the main channel, both the main channel and
the auxiliary channel being in fluid communication with at least
one lumen defined in the catheter tube; coupling the catheter to
the introducer hub by engaging a first unit of a multi-function
adapter on the junction housing to a second unit of the
multi-function adapter on the introducer hub such that the catheter
tube passes through the hemostasis valve into the access tube
lumen; infusing a medical solution to the vasculature through the
side arm and access tube lumen with or without the catheter coupled
to the introducer hub; and infusing a medical solution to the
vasculature through the catheter.
23. The method of claim 22, wherein the junction housing includes a
device valve positioned to provide a seal around medical devices
passed into the main channel, the method including introducing a
medical device through the device valve and through the catheter
and into the vasculature.
24. The method of claim 23, wherein the catheter tube has a length
sufficient to extend distally from the distal end of the access
tube when the catheter is coupled to the hub of the infusion
introducer, and wherein the medical device passes directly from the
catheter tube lumen into the vasculature without entering the
access tube lumen.
25. The method of claim 22, further including simultaneously
infusing medical solutions both through the side arm and access
tube lumen and through the catheter.
26. The method of claim 22, further including decoupling the
catheter from the introducer hub by disengaging the first and
second units of the multi-function adapter, and coupling a
different medical device to the introducer hub so that a different
catheter tube passes through the hemostasis valve into the access
tube lumen.
Description
RELATED APPLICATIONS
[0001] The present application is a divisional of Ser. No.
09/329,002, filed Jun. 8, 1999, entitled MULTIPLE LUMEN ACCESS
DEVICE, which is a continuation-in-part of co-pending U.S.
application Ser. No. 08/953,105, filed Oct. 17, 1997, which is a
continuation-in-part of U.S. application Ser. No. 08/756,763, filed
Nov. 26, 1996 under the same title, abandoned. The entire contents
of both of these prior applications are hereby incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical devices
which are used to provide access into the human body. More
particularly, the present invention is directed to access devices
which provide a single, relatively long-term, entry port into the
body. The entry port is used by doctors and other medical
professionals to selectively introduce a variety of medical
implements and fluids into the body and for in vivo diagnostic
testing and other treatment protocols.
[0004] 2. Description of Related Art
[0005] A wide variety of medical devices have been developed in
recent years for providing access into the human blood stream.
These devices have traditionally been divided into two different
groups based on their function and purpose. The first group of
devices includes catheters which are designed to introduce
therapeutic and/or diagnostic fluids into the blood stream. The
second group includes devices commonly referred to as "introducers"
which are designed to provide an intermediate term access port into
the body through which various medical implements may be passed for
therapeutic and/or diagnostic purposes. As a generalization,
catheters are longer and more flexible than introducers.
[0006] Central venous catheters are relatively long tubular devices
which have tapered distal tips which are designed for entry into
central veins to provide a dedicated route of fluid infusion into
the body. The original venous catheters were single lumen devices
which provided the ability to infuse a single liquid into the vein
at one time. Multiple lumen catheters have since been developed
which allow simultaneous introduction of two or more liquids into
the vein. The central venous pressure catheter is a type of common
multiple lumen catheter which allows the simultaneous introduction
and withdrawal of fluids as well as the capability of monitoring
blood pressure and other vital parameters. The portion of the
catheter which remains outside of the body has been continually
refined and redesigned to provide a low profile which increases
comfort and reduces the awkwardness associated with a dedicated
tube exiting the body.
[0007] Introducers are substantially different from catheters in
both design and purpose. An introducer is an access device which is
intended to provide a dedicated access port into the body.
Catheters, on the other hand, are intended to be used to infuse or
withdraw fluids from the body. Introducers typically include a
relatively short lumen through which various medical implements,
including catheters, can be selectively introduced and removed from
the body. An important feature of any introducer is the valve
assembly. The valve assembly provides a constant seal between the
blood stream and the in vitro environment as medical implements are
introduced and withdrawn from the body. The valve assembly is
typically located outside of the body at the proximal end of the
introducer. As a result, the proximal end of introducers has tended
to be relatively bulky.
[0008] In addition to a valve assembly, many introducers include a
side arm at the proximal end. The side arm is connected to the
lumen so that fluids can be introduced into the body simultaneously
with the medical device. The introducer lumen is considered to be a
"shared" lumen in that the lumen provides a common conduit for both
medical implements and fluid pharmaceuticals or diagnostics.
[0009] The currently available introducers and other access devices
are well-suited for their intended purpose. However, new medical
treatments and diagnostic procedures are continually being
developed which require more versatile access into the body. For
example, organ transplant procedures and cardiac angioplasty
require the introduction of complex combinations of medical
implements and diagnostic/therapeutic fluids into the body. Many of
the presently available access devices are not well-suited for
these relatively complex procedures. As a result, multiple access
devices are required which must be located at multiple access sites
necessitating multiple entry punctures. Accordingly, there is a
continuing need to provide improved access devices that have
additional capabilities which increase their versatility and
usefulness for the increasing variety of invasive treatments and
procedures.
SUMMARY OF THE INVENTION
[0010] In accordance with the present invention, an improved access
device is provided which is designed to provide selective
introduction of medical implements into the body while
simultaneously providing auxiliary access through dedicated
multiple lumens. The present invention is an improvement over
existing introducers and other access devices in that multiple
lumen access is provided through the introducer in addition to the
shared lumen which is used for both medical implements and fluid
pharmaceuticals or diagnostics. As an advantage, the improved
access device reduces the number of devices required to introduce
multiple implements and fluids into the body during complex
surgical and diagnostic procedures.
[0011] The present invention desirably includes a multiple lumen
access system for use in providing an entry port into the human
body for selectively introducing medical implements therethrough
and for providing simultaneous auxiliary access into the body. The
system includes a multiple lumen access device comprising an outer
tube which has a distal end for introduction into the body and a
cross-sectional area. A device lumen through which medical
implements may be passed is defined within the cross-sectional area
of the outer tube, the device lumen having a distal end and a
proximal end. At least one auxiliary lumen is defined within the
cross-sectional area and separately from the device lumen, the
auxiliary lumen having a distal end and proximal end. Finally, a
device lumen valve is associated with the proximal end of the
device lumen to provide sealing of the device lumen when medical
implements are both present and absent from the device lumen. Such
device lumen valve may be separate and detachable or it may be
integral with the system.
[0012] A multiple lumen access system according to the present
invention may also include a junction housing having a proximal end
and a distal end to which the proximal end of the outer tube
connects. The junction housing includes a main channel in fluid
communication with the device lumen and at least one auxiliary
channel in fluid communication with the at least one auxiliary
lumen, the main channel and auxiliary channel(s) diverging from the
outer tube to be non-intersecting in the junction housing.
[0013] In one embodiment, the device lumen valve is provided as a
part of the junction housing and is in fluid communication with the
main channel. A device channel may be formed in the junction
housing at an angle with the main channel and terminating at an
internal end in fluid communication with the main channel. The
device lumen valve may be positioned at an external end of the
device channel so that medical devices may be inserted therethrough
and enter the main channel at an angle. The main channel desirably
may continue from the distal end of the junction housing past the
device lumen to an opening in the junction housing enabling
introduction of fluids therethrough to the main channel. In one
embodiment, the device lumen valve is molded separately from the
junction housing of a material more rigid than the junction housing
and is assembled with the multiple lumen access device by insertion
in a cavity formed in the junction housing.
[0014] In an alternative embodiment, the main channel and auxiliary
channel(s) of the junction housing may be oriented substantially
coplanar so that the junction housing is substantially flat, the
system further including an extension tube extending from the
proximal end of the junction housing and in fluid communication
with the main channel wherein the device lumen valve is connected
to the extension tube to therefore be in fluid communication with
the main channel. A side port in the device lumen valve may be
provided enabling infusion of fluids to the extension tube and main
channel. Furthermore, mating threaded connectors may be included
between the device lumen valve and the extension tube enabling easy
removal of the device lumen valve. Any appropriate connector, for
example a luer connector, may be provided on the device lumen
valve, and the system may also include an infusion syringe having a
mating luer connector.
[0015] Further, in one embodiment, a multiple lumen access device
may be provided with a multi-lumen sheath, a junction housing
coupled to the multi-lumen sheath and a strain relief insert
coupled to the junction housing. The strain relief insert is formed
of a soft bendable material capable of flexing to prevent
multi-lumen sheath from kinking at the sheath/junction housing
coupling. In further embodiment, the multiple lumen access device
is formed by coupling a single lumen catheter to a junction housing
having a main channel and at least one auxiliary channel through a
multi-function adapter.
[0016] In another embodiment, the present invention is directed to
a multiple lumen access device including an outer tube which has a
distal end for introduction into the body and a proximal end which
remains outside of the body. The outer tube may have an exterior
surface and an interior surface, the interior surface defining an
access passageway which has a cross-sectional area which may vary
at different locations between the distal and proximal ends of the
outer tube. One or more inner walls are located within the access
passageway. The inner wall may form an inner tube that surrounds a
device lumen through which medical implements may be inserted into
the body. At least one auxiliary lumen is located between the
exterior surface of the inner wall and the interior surface of the
outer tube.
[0017] As another feature of the present invention, two or more
auxiliary passageways defined by the interior surface of the outer
tube and the exterior surface of the inner walls. The provision of
two or more auxiliary passageways allows introduction of additional
diagnostics or pharmaceutical liquids simultaneously with
introduction of a medical implement through the device lumen.
Embodiments of the present invention are also described wherein a
single auxiliary lumen is provided.
[0018] As a further desirable feature of the present invention the
inner walls are sufficiently flexible to be movable from a relaxed
position to expanded or contracted positions. The device lumen has
a first cross-sectional area in the relaxed position, and in the
expanded or contracted positions has cross-sectional areas which
are greater than or less than the first cross-sectional area, and
less than the cross-sectional area of the access passageway. The
flexibility of the inner walls is advantageous in that it allows
the insertion of a variety of medical implements having different
cross-sectional areas. This flexibility allows the cross-sectional
areas and resultant potential fluid flow rate for the auxiliary
lumens and the device lumen to be controlled as desired and
maximized within the confines of the access passageway.
[0019] As an additional feature of the present invention, spacer
ribs are provided, for example, on the interior surface of the
outer tube. The spacer ribs are located within the auxiliary lumens
to prevent complete closure of the lumens during insertion of
relatively large medical implements into the device lumen. The
spacer ribs located on the surface of the inner wall insure that
there is a passageway around devices located within the device
lumen.
[0020] An alternative multiple lumen access device of the present
invention comprises a tubular single lumen sheath having at least
one infusion port and an elongated implement sized to fit coaxially
within the single lumen sheath and form multiple independent
lumens, and when at least one of the lumens is in fluid
communication with the infusion port. The elongated implement may
be formed from a sufficiently flexible material so that at least
one lumen formed by the sheath and the implement has flexible walls
movable from a relaxed to a flexed positions. Another alternative
multiple lumen access device comprises a multi-lumen catheter
having a main lumen tube, at least one side lumen tube connected in
a side-by-side fashion with the main lumen tube and being peelable
from the main lumen to form sidearms, and a hub connected to the
main lumen tube and side lumen tube for fluid delivery or passage
of a medical device therethrough.
[0021] The present invention is also directed to a method for
introducing medical devices into the body through a single entry
port while allowing simultaneous introduction of other devices,
implements or fluids through the use of the multiple lumen access
device of the present invention. In one embodiment, the method
includes the steps of providing a multiple lumen access device in
accordance with the present invention having at least one flexible
wall; introducing the multiple lumen access device into the body
with the distal ends of the device lumen and the auxiliary lumen
being positioned within a vasculature of the body; and flowing a
medical solution through the auxiliary lumen to move the flexible
wall from the relaxed position to a flexed position.
[0022] In another embodiment, the method includes the steps of
providing a tubular single lumen sheath having proximal and distal
ends, at least one infusion port being provided on the proximal end
of the sheath; providing an elongated implement sized to fit
coaxially within the single lumen sheath, at least one of the
lumens being in fluid communication with the infusion port;
inserting the elongated implement into the single lumen sheath to
form multiple independent lumens therein; and flowing a medical
solution through one or more of the multiple independent
lumens.
[0023] The above-described and many other features and attendant
advantages of the present invention will become better understood
by reference to the following detailed description when taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a perspective view of an exemplary preferred
multiple lumen access device in accordance with the present
invention.
[0025] FIG. 2 is a sectional view of FIG. 1 taken in the 2-2 plane
of FIG. 1.
[0026] FIG. 3A is a sectional view taken in the same 2-2 plane of
FIG. 1 which shows a relatively small diameter medical device
located within the device lumen.
[0027] FIG. 3B is a sectional view taken in the same 2-2 plane of
FIG. 1 showing a relatively large diameter medical implement
located within the device lumen.
[0028] FIG. 4 is a sectional view of FIG. 1 taken in the 4-4
plane.
[0029] FIG. 5 is a sectional view of FIG. 1 taken in the 5-5
plane.
[0030] FIG. 6 is a perspective view of a preferred exemplary
embodiment in accordance with the present invention.
[0031] FIG. 7 is a sectional view of FIG. 6 taken in the 7-7
plane.
[0032] FIG. 8 is a sectional view of FIG. 6 taken in the 8-8
plane.
[0033] FIG. 9 is a sectional view of a preferred exemplary flexible
inner wall showing the location of spacing ribs.
[0034] FIG. 10 is a sectional view of a preferred exemplary
multiple lumen access device having a single auxiliary lumen.
[0035] FIGS. 11A-C are sectional views of an exemplary multiple
lumen access device showing a relatively small diameter medical
implement located in a central device lumen and the inner walls in
relaxed conditions (11A), partially collapsed about the implement
due to pressurization of side auxiliary lumens (11B), and
substantially completely collapsed about the implement (11C).
[0036] FIG. 11D is a sectional view of an alternative multiple
lumen access device having flexible walls made of a material
different from the material of the outer tube of the multiple lumen
access device.
[0037] FIG. 12 is a graph illustrating an increase in the
cross-sectional area (in gauge size) of an auxiliary lumen, such as
in the cross-section shown in FIGS. 11A-11C, as the differential
pressure between the auxiliary lumen and the device lumen
changes.
[0038] FIG. 13 is a sectional view of an alternative multi-lumen
sheath for use in the present invention having a device lumen on
one side and two side-by-side auxiliary lumens.
[0039] FIG. 14 is a sectional view of an alternative multi-lumen
sheath for use in the present invention having a device lumen on
one side and two stacked auxiliary lumens.
[0040] FIG. 15 is a sectional view of an alternative multi-lumen
sheath for use in the present invention having no flexible walls
therein.
[0041] FIG. 16 is a perspective view of a further embodiment of a
multiple lumen access device in accordance with the present
invention.
[0042] FIG. 17 is a perspective sectional view of FIG. 16 taken in
the 17-17 plane.
[0043] FIG. 18A is a perspective view of an extrusion die for
making a sheath portion of the multiple lumen access device of the
present invention.
[0044] FIG. 18B is an end view of a sheath portion of the multiple
lumen access device as extruded from the die shown in FIG. 18A.
[0045] FIGS. 18C and 18D are isolated views of inner extrusion
molds of the die shown in FIG. 18A with exemplary dimensions for
the sheath portion cross-section called out.
[0046] FIG. 19 is an enlarged perspective view of a junction
housing of the device shown in FIG. 16.
[0047] FIG. 20 is an enlarged perspective of the junction housing
of FIG. 19 with a portion cut away on the longitudinal axis.
[0048] FIG. 21 is a perspective assembled view of a valve insert
used in the junction housing of FIG. 16.
[0049] FIG. 22 is an exploded perspective view of the valve insert
of FIG. 21.
[0050] FIGS. 23A and 23B are two perspective views of a multiple
lumen access device similar to that shown in FIG. 16.
[0051] FIG. 24 is an elevational view of the multiple lumen access
device of FIGS. 23A/23B in place in the vasculature of a
patient.
[0052] FIG. 25A is a perspective view of a junction housing of the
device shown in FIGS. 23 and 24 showing a valve insert and strain
relief insert both exploded therefrom.
[0053] FIG. 25B is a reversed perspective view of the strain relief
insert adapted to be coupled to the junction housing in FIG.
25A.
[0054] FIG. 26 is an exploded elevational view of the valve insert
shown in FIG. 25A.
[0055] FIG. 27 is a perspective view of a clamp portion for the
valve insert of FIG. 26.
[0056] FIGS. 28A and 28B are perspective views of an adapter which
mates with the valve inserts of FIGS. 21 or 26.
[0057] FIG. 29 is an elevational view of a multiple lumen access
device in accordance with the present invention.
[0058] FIG. 30 is a plan view of the multiple lumen access device
of FIG. 29 showing more details of an associated catheter
system.
[0059] FIG. 31 is a perspective view of a proximal end of a
low-profile junction housing of the device of FIG. 29.
[0060] FIG. 32 is a plan view of an alternative multiple lumen
access device with a low profile junction housing.
[0061] FIG. 33 is a detailed view of an alternative introducer
valve assembly for use in the device of FIGS. 30 or 32.
[0062] FIG. 34 is a plan view of an alternative multiple lumen
access having a multi-lumen infusion catheter interfacing with a
single lumen introducer.
[0063] FIGS. 35A-35D are schematic sectional views of sheath/lumen
configurations for use in the multi-lumen infusion catheter of FIG.
34.
[0064] FIG. 36 is a sectional view of a junction housing used in
the device of FIG. 34.
[0065] FIG. 37 is an elevational view of a further embodiment of a
multi-lumen sheath for use in the device of FIG. 34.
[0066] FIG. 38 is a sectional view of the multi-lumen sheath of
FIG. 37.
[0067] FIG. 39 is a plan view of a multiple lumen access device
having a center tube and two side lumen tubes in accordance with
the present invention.
[0068] FIGS. 40A and 40B are sectional views of a sheath of the
multiple lumen access device of FIG. 39 taken along lines 40A-40A
and 40B-40B, respectively.
[0069] FIG. 41 is an alternative multiple lumen access device with
discrete tubes as in FIG. 39 and having a junction housing.
[0070] FIG. 42A is an exploded view of a multiple lumen access
device having an introducer connected to a multi-lumen catheter by
an adjustable adapter.
[0071] FIG. 42B is an assembled view of the multiple lumen access
device of FIG. 42A.
[0072] FIG. 43A is an exploded view of a multiple lumen access
device having an introducer with infusion port connected to a
multi-lumen catheter by an adapter.
[0073] FIG. 43B is an assembled view of the multiple lumen access
device of FIG. 43A.
[0074] FIG. 44A is an exploded view of a multiple lumen access
device having an introducer with infusion port connected to a
triple lumen junction housing and obturator by an adapter.
[0075] FIG. 44B is an assembled view of the multiple lumen access
device of FIG. 44A.
[0076] FIG. 45A is an exploded view of a multiple lumen access
device having an introducer connected to triple lumen junction
housing by a threaded adapter.
[0077] FIG. 45B is an assembled view of the multiple lumen access
device of FIG. 45A.
[0078] FIG. 46A is an exploded view of a multiple lumen access
device having an introducer connected to triple lumen junction
housing and elongated infusion tube by a threaded adapter.
[0079] FIG. 46B is an assembled view of the multiple lumen access
device of FIG. 46A.
[0080] FIG. 47A is an exploded view of a multiple lumen access
device having an introducer with infusion port telescopically
fitting within a larger introducer.
[0081] FIG. 47B is an assembled view of the multiple lumen access
device of FIG. 47A.
[0082] FIG. 48A is an exploded view of a multiple lumen access
device with a multi-ribbed hollow obturator telescopically fitting
within an introducer with infusion ports.
[0083] FIG. 48B is an assembled view of the multiple lumen access
device of FIG. 48A.
[0084] FIG. 49 is an assembled view of a multiple lumen access
device similar to that shown in FIG. 48B with infusion ports formed
on a hub of the multi-ribbed hollow obturator.
[0085] FIG. 50A is an exploded view of a multiple lumen access
device with a multi-ribbed solid obturator telescopically fitting
within an introducer with infusion ports.
[0086] FIG. 50B is an assembled view of the multiple lumen access
device of FIG. 50A.
[0087] FIG. 51 is an exploded sectional view of a multiple lumen
access device with a multi-ribbed hollow obturator telescopically
fitting within a tapered introducer with an infusion port.
[0088] FIG. 52 is an assembled view of the multiple lumen access
device of FIG. 51.
[0089] FIG. 53 is a sectional view of the obturator seen in FIG. 51
taken along line 53-53.
[0090] FIG. 54 is a perspective view of a portion of the obturator
seen in FIG. 51.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0091] An exemplary multiple lumen access device (MLAD) in
accordance with the present invention is shown generally at 10 in
FIGS. 1-5. The device 10 includes an outer tube 12 which has a
distal end 14 and a proximal end 16. As best shown in FIGS. 2-5,
the outer tube 12 has an exterior surface 18 and an interior
surface 20. The interior surface 20 defines an access passageway or
lumen 22 which has a cross-sectional area that may vary at
different locations between the distal 14 and proximal 16 ends of
the outer tube 12. Typically, the outer tube 12 may be tapered at
the distal end 14, if desired. As a result of the tapering of the
outer tube 12, the cross-sectional area will decrease
accordingly.
[0092] In accordance with the present invention, an inner tube 24
is located within the access passageway 22. The inner tube 24 has a
distal end and a proximal end which correspond to the distal end 14
and proximal end 16 of the outer tube 12. As illustrated in FIG. 2,
the inner tube 24 is formed by a wall surrounding a device lumen
30, the wall having an exterior surface 26 and an interior surface
28. The interior surface 28 defines a device lumen 30 through which
medical implements (such as catheters 32 and 34 shown in FIGS. 3A
and 3B, respectively) may be inserted into the body. Catheter 34 is
also shown in position within the device lumen 30 in FIGS. 4 and
5.
[0093] Two auxiliary lumens 36 and 48 are located between the
exterior surface 26 of the inner tube 24 and the interior surface
20 of the outer tube 12. The auxiliary lumens 36 and 48 each have a
distal end and a proximal end which correspond generally to the
distal and proximal ends of the outer tube 12 and inner tube 24. In
this particular preferred embodiment, the surfaces which define the
auxiliary lumens 36 and 48 correspond to portions of the interior
surface of the outer tube and exterior surface of the inner tube.
Specifically, auxiliary lumen 36 is defined or bordered by an
interior surface 38 which corresponds to the interior surface 20 of
the outer tube 12 and the exterior surface 26 of the inner tube 24.
Further, the auxiliary lumen 36 is defined by separation surfaces
40 and 42 which are formed by separation barriers 44 and 46,
respectively.
[0094] A second auxiliary lumen 48 is also formed or defined by the
interior surface 20 of the outer tube 12 and the exterior surface
26 of the inner tube 24. Accordingly, the interior surface 50 which
defines the second auxiliary lumen 48 corresponds to these
surfaces. In addition, the auxiliary lumen 48 is bordered by
separation surfaces 52 and 54 formed by separation barriers 44 and
46, respectively.
[0095] Referring to FIG. 1, the multiple lumen access device 10
includes a junction housing 56. The junction housing 56 is
connected to the proximal end 16 of the access lumen 12. The
housing 56 includes infusion tubes 58 and 60 which are connected
through the housing 56 to auxiliary lumens 36 and 48, respectively.
The infusion tubes 58 and 60 include luer connectors 62 and 64.
Other conventional connection devices may be used. A third infusion
tube 66 is connected via the housing 56 to the device lumen 30 in
order to provide a route for infusion of liquid into the device
lumen 30. It should be noted that the infusion tube 66 is not
connected to the junction housing 56 at a right angle as is
typically done in conventional introducer-type devices. Instead,
the infusion tube 66 extends from the housing 56 parallel to the
other two infusion tubes 58 and 60. This parallel orientation of
the tubes 58, 60 and 66 allows housing 56 to be a low profile body
which reduces the bulkiness of the proximal end of the device and
increases its wearing comfort. A conventional locking device, such
as luer lock 68 is also provided at the proximal end of the
infusion tube 66.
[0096] The housing 56 includes a valve 70 through which various
medical implements are inserted into the device lumen 30. Valve 70
includes a valve or gasket assembly which is designed to provide
sealing of the device lumen 30 when medical implements are both
present and absent from the device lumen 30. Any of the known
gasket arrangements and valve mechanisms used to provide sealing of
introducers and related medical implement access devices are
suitable. The multiple lumen access device 10 is designed for use
in combination with providing access to either the arterial or
venous sides of the bloodstream.
[0097] An opening 72 (see FIG. 1 and FIG. 5) is provided towards
the distal end of outer tube 12. The opening 72 is provided to
allow exit of fluid from auxiliary lumen 48 which has been
introduced through infusion tube 58. Likewise, an opening 74 (shown
in phantom in FIG. 1 and also shown in FIG. 4) is provided for
allowing the fluid introduced through infusion tube 60 to exit
auxiliary lumen 36 at the distal end of the outer tube 12.
[0098] As illustrated in FIGS. 1, 4 and 5, the openings 72 and 74
are preferably sized to avoid restricting fluid flow through the
respective auxiliary lumens. Therefore, it is preferred that the
openings 72 and 74 are each sized sufficiently large to be equal or
greater than the maximum distended/expanded cross-sectional area of
the corresponding auxiliary lumens 36 and 48. Of course, this same
principle applies with regard to any number of auxiliary lumens
each having a variable cross-section. When either auxiliary lumen
36, 48 is under pressure and no device is present in the device
lumen 30, the auxiliary lumen cross-section increases in diameter.
In one preferred embodiment, the auxiliary lumen increases, for
example, from approximately 15 gauge to about 12 gauge, while in
another embodiment the auxiliary lumen increases from approximately
18 gauge to about 14 gauge. Therefore, the openings 72 and 74 are
each sized to be equivalent to or greater than 12 gauge or 14
gauge, respectively, to avoid restricting fluid flow through the
respective auxiliary lumen. When other cross-section diameters of
the auxiliary lumens are used, the size of the openings, such as 72
and 74, are preferably sized accordingly.
[0099] In this exemplary embodiment of the present invention, the
inner tube 24 must be sufficiently flexible to be stretchable
between a relaxed position as shown in FIG. 3A and various expanded
positions as exemplified in FIG. 3B. In FIG. 3A, a catheter 32
having a diameter of 1.3 millimeter (4 French) is shown inserted
within the device lumen 30. The inner tube 24 is in a relaxed
position where the cross-sectional area of the device lumen 30 is
approximately 2 square millimeters. The relaxed cross-sectional
area of the device lumen 30 will preferably range from 1 to 3
square millimeters. Larger diameters are possible, if desired. It
is preferred, but not required, that inner tube 24 have a circular
or elliptical cross-section.
[0100] As shown in FIG. 3B, a larger diameter catheter 34 has been
inserted into the device lumen 30. The inner wall 24 is made from
sufficiently resilient material and is sufficiently sized so that
it can expand to the diameter shown which is approximately 3
millimeter (9 French). The maximum diameters to which the inner
tube 24 can be expanded is limited by the diameter of the outer
tube 12. The inner tube 24 may be flexed inward, if desired, by
applying fluid pressure through one or both auxiliary lumens 36 and
48. Typically, the cross-sectional area of the device lumen 30 when
the inner tube 24 is in its maximum expanded state will range from
5 to 9 square millimeters. Larger diameters are possible, if
desired. Preferably, the inner tube 24 will be sufficiently
flexible so that it can be expanded completely outward against the
interior surface 20 of the outer tube 12. In the fully expanded
state, the auxiliary lumens 36 and 48 will have substantially
reduced cross-sectional areas. However, it is preferred that the
auxiliary lumens 36 and 48 not be entirely closed. It is desirable
to leave some opening through these two auxiliary lumens 36 and 48
at all times to allow flushing fluids to be passed through the
lumens in order to prevent the formation of blood clots or other
problems associated with a completely collapsed lumen.
[0101] Preferably, the inner tube 24 is sufficiently flexible to be
stretched to expanded positions wherein the cross-sectional area of
the device lumen 30 in the expanded state is up to 85 percent of
the cross-sectional area of the access lumen 22. This allows for
continual auxiliary fluid introduction through auxiliary lumens 36
and 48. Further, it is preferred that in the relaxed position as
shown in FIG. 3, that the device lumen 30 have a cross-sectional
area which is not less than 35 percent of the cross-sectional area
of the access lumen 22.
[0102] In accordance with the present invention, the inner tube 24
is preferably connected to the outer tube 12 at separation barriers
44 and 46 in order to divide the access lumen 22 into a
three-chamber lumen, i.e. the central device lumen 30 and two
auxiliary lumens 36 and 48. In order to achieve the desired
flexibility of the device lumen 30, it is preferred that a
relatively elastic material be utilized. Suitable elastic materials
include, but are not limited to, polyvinylchloride, polyurethane,
polyethylene, nylon, silicone, fluoropolymers and polypropylene.
Further, in order to achieve the desired variation in lumen
cross-sectional areas, the thickness and durometer of the inner
tube walls 24 must be carefully matched to the particular material
being utilized. For less flexible materials, the wall thicknesses
must be correspondingly reduced in order to achieve the desired
flexibility limits. The inner tube 24 should be sufficiently
flexible so that it can be expanded to diameters which are at least
as large as the outer tube 12.
[0103] Another exemplary embodiment in accordance with the present
invention is shown generally at 100 in FIG. 6. The access device
100 is similar to the previous preferred embodiments in that it
includes an outer tube 112 having a distal end 114 and a proximal
end 116. As best shown in FIGS. 7 and 8, the outer tube 112 has an
exterior surface 118 and an interior surface 120. The interior
surface defines an access passageway 122 in which an inner tube 124
is located. The inner tube 124 includes an exterior surface 126 and
an interior surface 128. The interior surface 128 of the inner tube
124 defines a device lumen 130 through which medical implements,
such as a catheter, may be inserted. The access device 100 includes
three separation barriers 132, 134 and 136 which, in combination
with the interior surface of the outer tube 120 and exterior
surface of the inner tube 126, form three auxiliary lumens 138, 140
and 142. The multiple lumen access device 100 includes the same
type of junction housing 144 which was described in the
previously-described preferred embodiment (FIGS. 1-5), except that
an additional infusion lumen is included to provide infusion of
liquid into the additional auxiliary lumen. As shown in FIG. 6,
infusion lumens 146, 148 and 150 are connected via junction housing
144 to auxiliary lumens 138, 140 and 142, respectively. A primary
infusion lumen 152 is also provided for introducing fluids into the
device lumen 130. Again, an access port 154 is provided with the
appropriate gaskets and/or valving mechanism to allow introduction
of catheters and other medical devices into the device lumen
130.
[0104] The inner tube 124 in this exemplary embodiment may or may
not be made from flexible material. The inclusion of three
separation barriers in this particular embodiment reduces the
ability for flexible expansion and contraction of the inner tube
124. However, it is preferred that the material used to form the
device lumen 124 and the separation barriers be more flexible than
the exterior outer tube 112 in order to allow variations in the
cross-sectional areas of the auxiliary lumens. Otherwise, the same
materials and fabrication techniques which are used to fabricate
the prior embodiments are also suitable for use in making the
multiple lumen access device 100.
[0105] In a preferred embodiment, as shown in FIG. 9, spacer ribs
210 are provided on the interior surface 220 of the outer tube 212
to prevent the inner tube 224 from being expanded to a position
which closes the auxiliary lumens 236 and 248. Spacer ribs 211 may
also be provided to insure that a passageway 213 is maintained
around a device 215 when it is located within device lumen 230. The
ribs 210 are preferably located longitudinally along the entire
length of the outer tube 212 where the inner tube 224 is also
present. The particular cross-sectional shape of the spacer ribs
210 is not particularly important so long as they are relatively
blunt and do not damage the inner tube 224 during contact
therewith. The number and relative positioning of the spacer must
be chosen to insure that complete closure of the auxiliary lumens
236 and 248 does not occur. For inner tubes 224 which are
relatively flexible, the number and size of ribs may have to be
increased. The ribs 210 shown in FIG. 9 are an example of a
preferred configuration. The number, shape, size and position of
the ribs 210 may be varied as required in order to prevent closure
of the auxiliary lumens 236 and 248 as discussed above.
[0106] Although more than two auxiliary lumens may be included into
the access device, it is preferred that two lumens be utilized. The
use of two lumens is a preferred design for allowing uniform
expansion of the inner tube 24 between the relaxed state as shown
in FIG. 3A and an expanded state as shown in FIG. 3B.
[0107] Access devices which include one auxiliary lumen are also
possible. The cross-section of an exemplary access lumen is shown
at 310 in FIG. 10. The access lumen 310 includes an outer tube 312
which defines an access lumen 322. The access lumen 322 is divided
into a device lumen 330 and an auxiliary lumen 336 by an inner
flexible wall 324. The inner surface of the outer wall 312
preferably includes spacer ribs (shown in phantom at 350) to
prevent closure of the auxiliary lumen 336. The inner wall 324 is
made from the same types of flexible materials as described
previously for the inner tubes used in the multiple auxiliary lumen
embodiments. This particular embodiment is well-suited for use in
those situations where a relatively large device lumen is required
in favor of the advantages provided by multiple auxiliary
lumens.
[0108] The outer wall 12 is preferably made from any of the
well-known polymer materials used in fabricating introducers and
other access devices. Exemplary materials include polyurethane,
polyethylene, polypropylene, nylon, polyester, polyether/ester
copolymers, silicone based polymers, metalocene catalyzed
polyolefins or ethylene vinyl acetate and synthetic rubbers.
Preferably, the material used and wall thicknesses for the outer
wall 12 are such that the outer wall 12 is a relatively stiff tube
in relation to the inner tube 24. Further, the material used for
the outer wall 12 should be compatible for molding purposes with
the material used to form the inner wall 24. It is preferred that
the outer wall 12 and inner wall 24 be extruded together, as will
be more fully described below. The outer wall 12 and inner wall 26
may be made from the same material or different materials. The
inner wall 26 is preferably made from softer versions of the
various polymers listed above. When using different materials, the
materials must be compatible for bonding or fusing together.
[0109] Other fabrication techniques for connecting the inner and
outer tubes are possible provided that the connection between the
two lumens at the separation barriers 44 and 46 extends the entire
length of the two lumens and provides a solid integral connection
between the lumens. For example, radio frequency (RF) welding of
the tubes is another possible fabrication procedure which may be
used to make the access lumen in accordance with the present
invention. If desired, the entire triple lumen can be extruded as a
single integral multiple lumen structure.
[0110] During use, the exemplary access device 10 allows
introduction of medical implements into the device lumen while at
the same time allowing infusion of fluid through tube 66 also into
device lumen, as well as allowing infusion through tubes 58 and 60
into auxiliary lumens 48 and 36, respectively. Since, as discussed
above, the outer tube 12 is relatively inflexible in the radial
direction (though overall longitudinally flexible), the total
available cross-sectional area for insertion of medical implements
and flow of fluids is limited for a given access device. However,
the flexibility of the device lumen allows the doctor or other
medical professional to selectively and fully utilize the total
available cross-sectional area.
[0111] In FIG. 3A, a relatively small catheter 32 is shown inserted
within the device lumen 30. In this configuration, fluids may be
infused/removed through the unused area of the device lumen 30 as
well as the two auxiliary lumens 36 and 48. It should be noted that
the preferred design inherently centers the catheter or medical
implement 32 so that the auxiliary lumens 36 and 48 have
approximately equal cross-sectional areas. However, it should be
noted that the application of differential pressure to the infusion
tubes 58 and 60 can be used to selectively increase or decrease the
relative cross sectional areas available for infusion of fluids
through the auxiliary lumens. For example, the size of auxiliary
lumen 36 can be increased relative to the cross-sectional size of
auxiliary lumen 48 by introducing the infusion of liquid through
tube 58 at a pressure which is relatively higher than that of tube
60. The double auxiliary lumen design of this exemplary embodiment
is especially well suited for providing such differential fluid
flows when desired.
[0112] An exemplary embodiment which further demonstrates the
flexibility of devices in accordance with the present invention is
demonstrated in FIGS. 11A-11C. In FIG. 11A, an exemplary access
device 21 is shown in which a relatively small catheter 33 is
located within the device lumen 31. In this configuration, fluids
may be infused/removed through the unused area of device lumen 31
as well as the two auxiliary lumens 37 and 49. As shown in FIG.
11A, the inner flexible walls 25 is in a relaxed position. In this
position, the inner wall 25 is relatively close to the outer wall
15. When desired, the size of the auxiliary lumens 37 and 49 can be
increased substantially by increasing the pressure of liquids being
passed therethrough. The result, as shown in FIG. 11B, is the
partial collapsing of the inner tube or inner walls 25 about the
catheter 33. In the partially contracted or collapsed position as
shown in FIG. 11B, the inner walls 25 are not stretched. Instead,
their configuration changes as shown in FIG. 11B to accommodate the
change in relative sizes of the auxiliary lumens and device lumen.
As shown in FIG. 11C, the size of auxiliary lumens 37 and 49 are
increased even further to a point where the fluid flow through the
two auxiliary lumens is maximized. In this condition, stretching of
the contracted flexible walls 25 may occur. As is apparent from
FIGS. 11A-11C, it is possible to provide a wide variance in fluid
flows through the auxiliary lumens and device lumen depending upon
differential pressures applied through the various lumens.
[0113] Alternative Sheath Cross-Sections
[0114] FIG. 13 illustrates an alternative cross-section of a sheath
portion 340 for the multiple lumen access device of the present
invention in which the device lumen is not between two auxiliary
lumens. The sheath portion of the devices of the present invention
comprise the portion that is distally disposed with respect to the
junction housing, defines multiple lumens therein, and is
substantially inserted into the patient's vasculature. In FIG. 13,
the sheath portion 340 comprises an outer tube 342 defining within,
and, in series from left to right, a device lumen 344, a first
auxiliary lumen 346, and a second auxiliary lumen 348. A first
flexible wall 350 separates the device lumen 344 from the first
auxiliary lumen 346, while a second wall 352, that can be flexible
or relatively rigid, separates the first and second auxiliary
lumens 346, 348. The first flexible wall 350 can move from its
position shown in solid line to the dashed-line position shown at
354 as the pressure difference across the wall increases in favor
of the first auxiliary lumen 346. Likewise, the second flexible
wall 352, if flexible, can move from its position shown in solid
line to the dashed-line position shown at 356 as the pressure
difference across the wall increases in favor of the second
auxiliary lumen 348.
[0115] FIG. 14 is a further alternative cross-section of a sheath
portion 360 for the multiple lumen access device of the present
invention. The embodiment of FIG. 14 is similar to that shown in
FIG. 13, and includes a device lumen 362, first auxiliary lumen
364, and second auxiliary lumen 366, all defined with an outer tube
368. In contrast to the embodiment of FIG. 13, the auxiliary lumens
364 and 366 are not arranged side-by-side, but are instead stacked
on top of one another (at least in the orientation shown) so that
both are located adjacent the device lumen 362. In this respect, a
generally T-shaped internal dividing wall is provided including an
elongated wall portion 370 and a shorter wall portion 372. The
shorter wall portion 372 separates the first and second auxiliary
lumens 364,366, while the elongated wall portion 370 separates the
two auxiliary lumens from the device lumen 362. Both the elongated
wall portion 370 and the shorter wall portion 372 are curvilinear
in their relaxed configurations, shown in solid line in FIG. 14.
The wall portions 370 and 372 straighten out into the dashed-line
positions upon an increase in pressure in one or both of the
auxiliary lumens 364, 366 relative to the device lumen 362.
[0116] In another alternative embodiment, not illustrated, the
device lumen can be provided between two or more auxiliary lumens
of different sizes. The device lumen is typically positioned
off-center between crescent-shaped auxiliary lumens, and at least
one of the auxiliary lumens can be expandable in accordance with
the preceding discussion (that is, a wall between one of the
auxiliary lumens and the device lumen is flexible). Desirably,
there are two auxiliary lumens and the larger of the two lumens is
expandable to enable infusion of large flow rates. In one
particularly preferred embodiment, the larger lumen has a capacity
equivalent to a gravity flow through a 14 gauge lumen.
[0117] FIG. 15 illustrates a still further cross-sectional view of
a sheath portion 380 which may be used in conjunction with the
multiple lumen access device of the present invention. In this
embodiment, the sheath portion 380 includes a generally cylindrical
solid member 382 having a central device lumen 384 and a plurality
of auxiliary lumens 386 surrounding the device lumen formed
therein. There are no flexible walls in this embodiment, it being
understood that various aspects of the present invention may be
advantageously utilized without the need for varying the
cross-sectional shape of any of the lumens within the sheath
portion 380. Alternatively, if desired, any wall portion separating
the device lumen 384 from any of the auxiliary lumens 386 may be
formed to be flexible to enable variability of the cross-section of
that lumen.
[0118] The graph illustrated in FIG. 12 shows that as pressure
inside the auxiliary lumen increases the cross-sectional area of
that lumen increases. (The convention is that cross-section in
terms of "gauge" numbers actually decreases for larger areas). FIG.
12 reflects the pressure response of one exemplary multi-lumen
catheter wherein the auxiliary lumen increases in size from about
15 gauge when there is no flow therethrough, to about 12 gauge with
fluid infusion at a pressure of about 300 mmHg (in this sense, the
300 mmHg is the differential pressure across the flexible wall, if
the assumption is made that the device lumen is at atmospheric
pressure). The response curve of the increase in lumen size
indicates that the flexible wall is sufficiently rigid to withstand
small changes in pressure. From 0-150 mmHg, the auxiliary lumen
increases only from slightly smaller than 15 gauge to slightly
larger than 15 gauge. Only above 150 mmHg pressure differential
does the lumen size significantly increase. This response is a
factor of the thickness, shape and material of the flexible wall
between the device and auxiliary lumens.
[0119] One of the advantages of having an inner wall 25 (as seen in
FIG. 11A) or inner wall 350 (as seen in FIG. 13) which is flexible
but also sufficiently rigid is that a pressure transducer may be
connected to the multi lumen access device of the present invention
to monitor a central venous pressure of a patient. In particular,
the pressure transducer (not shown) may be placed in communication
with one of the auxiliary lumens 37 and 49 to measure the central
venous pressure. Advantageously, the resistance to small pressure
differentials described above enables more accurate pressure
monitoring, because the flexible wall does not substantially flex
upon small differentials in pressure, and thus does not dampen or
attenuate the resultant pressure wave sensed externally to the
lumen. Specifically, the flexible inner walls 25 have sufficient
stiffness to avoid significant damping or attenuation of pressure
pulses in the auxiliary lumens 37 and 49, and do not undergo major
flexing from small pressure differentials as shown in FIG. 12.
[0120] As described previously in regards to the exemplary
embodiment illustrated in FIGS. 1-5, the outer wall 15 of the
embodiment illustrated in FIGS. 11A-11C is preferably made from any
of the well-known polymer materials used in fabricating introducers
and other access devices. Preferably, the material used and wall
thickness for the outer wall 15 are such that the outer wall 15 is
a relatively stiff tube in relation to the inner walls 25 in the
radial direction. Further, the material used for the outer wall 15
should be compatible for molding purposes with the material used to
form the inner walls 25. It is preferred that the entire
cross-section of the multi-lumen portion of the device 10,
including the outer tube 12 and inner walls 25, is extruded
together from a homogeneous material. Alternatively, the outer wall
15 and inner walls 25 may be coextruded and that the junctions 27
be formed by molding of the inner 25 and outer wall 15 together
during the coextrusion process, as seen in FIG. 11D. Therefore,
outer wall 15 and inner walls 25 may be made from the same material
or different materials, as shown in FIG. 11D. The inner wall 25 is
preferably made from softer versions of the various polymers listed
previously. When using different materials, the materials should be
compatible for bonding or fusing together.
[0121] The above described exemplary embodiments may be used in the
same manner as conventional introducer devices. Additionally, if
desired, the devices may be used in the same manner as conventional
central venous pressure catheters. As will be appreciated by those
skilled in the art, the present invention provides the design
flexibility to allow use as a single device where the capabilities
of an introducer device and catheter are simultaneously required.
For example, many diagnostic and invasive medical procedures
require the insertion of guide wires and/or medical devices, while
simultaneously monitoring critical bodily functions and introducing
or removing fluids as needed. The access device of the present
invention allows all of the above functions to be performed
simultaneously and selectively through a single access device.
[0122] MLAD with Valve Insert
[0123] FIG. 16 illustrates an alternative multiple lumen device 400
(MLAD) in accordance with the present invention with an improved
junction housing 402. The device 400 is similar to the FIGS. 1-5,
and includes a multiple lumen sheath 404 extending distally from
the housing 402. The multiple lumen sheath has a distal end 406 for
insertion in a body cavity and a proximal end 408 attached to the
housing 402. A plurality of extension tubes 410 is attached to the
proximal end of the housing 402 and terminate in luer connectors
412. The housing comprises a valve insert portion 414 and a low
profile lumen portion 416. A valve insert 418 is secured in a
cavity defined in the portion 414. A pair of mounting wings 420 is
integrally formed with the junction housing 402 for attaching to a
patient.
[0124] The multiple lumen sheath 404 seen in cross-section in FIG.
17 comprises an outer circular tube 422 having an interior surface
424. In the illustrated embodiment, the multiple lumen sheath 404
includes a central device lumen 426 and a pair of auxiliary lumens
428 disposed on opposite sides of the device lumen. The device
lumen 426 is defined between interior surfaces 430 of a pair of
divider walls 432. The divider walls extend in a non-linear fashion
substantially across the entire outer tube 422 and terminate at
junctions 434. The junctions 434 are spaced a slight distance from
one another so that the sheath 404 does not exhibit the separation
barriers, as previously described. As illustrated, the device lumen
426 is generally concentrically positioned within the outer tube
422 and has a nominal diameter of slightly greater than half the
outer tube 422. Between exterior surfaces 436 of the divider walls
432 and the interior surfaces 424 of the outer tube 422, the
auxiliary lumens 428 are formed. The lumens 428 are substantially
crescent shaped and are shown identical in size. Of course, as
described previously, various other lumen configurations can be
provided in the multiple lumen sheath 404.
[0125] The junction housing 402 is illustrated in greater detail in
FIGS. 19 and 20. The low profile lumen portion 416 has an oval
cross-section tapering gradually wider along its long axis from the
multiple lumen sheath 404 to a proximal face 440 to which the
extension tubes 410 connect. The valve housing portion 414 angles
upward from one wide surface of the lumen portion 416 and
terminates in a proximal face 442. The device access valve insert
418 fits within an angled cavity formed in the valve housing
portion 414. With specific reference to FIG. 19, the lumen portion
416 comprises a main channel 444 and a pair of auxiliary channels
446 on either side. The main channel communicates with a central
extension tube 410, while the auxiliary channels 446 communicate
with the side extension tubes. A device channel 448 defined within
the valve housing portion 414 is in communication with the main
channel 444 and angles upwardly therefrom to terminate in a widened
cavity 450. The cavity 450 receives the valve insert 418 which is
held therein by a circumferential lip 452 on the outermost portion
of the cavity 450. The cavity 450 continues inward from the lip 452
towards the device channel 448 and narrows at a step 454. The step
454 provides a stop surface against which the valve insert 418 is
pressed. Desirably, the insert 418 and cavity 450 are keyed to
facilitate insertion in a particular rotational orientation and
prevent further rotation.
[0126] Valve Insert
[0127] Now with reference to FIGS. 21 and 22, the device access
valve insert 418 is seen in greater detail. The valve insert 418
comprises four components: an outer frame 460, a wiper 462, a valve
464, and a sleeve 466. The assembled valve insert 418 is seen in
FIG. 18. The wiper 462 and valve 464 are juxtaposed within an outer
wall 468 of the frame 460, and held therein by the interaction
between a flange 470 of the sleeve 466 and a pair of cantilevered
latches 472 provided on the frame. The sleeve 466 further includes
a support tube 474 projecting downward from the flange 470 and
surrounding the valve 464. The wiper 462 includes an aperture 476
through which device catheters may be inserted in a sealed fashion.
The valve 464 may be a conventional duck-billed valve having a
valve slit 478, as seen in FIG. 17. The combination of the wiper
462 and the valve 464 effectively seals the device channel 448
formed within the junction housing 402 and the exterior of the
junction housing when devices are repeatedly introduced and
withdrawn through the valve insert 418. The outer wall 468 further
includes a pair of partial threads 480 which cooperate with
exterior threads on an infusion catheter dilator or contamination
shield (not shown).
[0128] The entire valve insert 418 is formed separately from the
junction housing 402, which is molded from a soft, flexible
material, typically a soft thermoplastic material. The softness of
the junction housing 402 is important in enhancing patient comfort
and flexibility of the entire multi-lumen access device 400 when
assembling and mounting to a patient. Conversely, the frame 460 of
the valve insert 418 is relatively rigid for supporting the wiper
462 and duck-billed valve 464. The wiper and duck-billed valve are
made of elastomeric materials, and the outer wall 468 prevents
valve depression or distortion and thus enhances the patency of the
seal formed by the valve insert 418. The sleeve 466 stabilizes the
elastomeric valve components, and the support tube 474 provides an
outer surface against which the duck-billed valve 464 cannot extend
past. The rigidity of the valve insert 418 provides structure to
facilitate connection of devices thereto. Furthermore, the junction
housing 402 is easily injection molded over the multiple lumen
sheath 404 and tubes 410 prior to addition of the insert 418, for a
simplified manufacturing process.
[0129] Sheath Cross-Section Formation and Details
[0130] FIG. 18A illustrates in perspective an extrusion die 390
used to extrude a preferred cross-section of sheath portion of a
multiple lumen access device of the present invention, such as the
cross-section shown in FIG. 17. The extrusion die 390 comprises a
large tubular member 392 having a bore 393, and a plurality of
lumen-forming mandrels positioned longitudinally therein.
Specifically, a device lumen-forming mandrel 394 and two
surrounding auxiliary lumen-forming mandrels 396a, 396b are
positioned within the bore 393 using elongated pins (not shown)
closely fitting within guide holes 398.
[0131] As it is known in the extrusion art, material such as
polyurethane in liquid form can be forced through the cavities
formed between the bore 393 and the mandrels 394,396 and gradually
cooled so that when the material exits from the extrusion cavity it
has solidified somewhat and retains the shape shown in FIG.
18B.
[0132] FIG. 18B is a cross-sectional view of the exemplary sheath
404 of FIG. 16 and includes an outer tube 422 and two inner walls
436 together defining device lumen 426 and the surrounding
auxiliary lumens 428, as described in more detail below.
[0133] FIGS. 18C and 18D are more detailed views of the surfaces of
the mandrels 394 and 396 in one preferred embodiment of the present
invention. The outer diameter of the auxiliary lumen-forming
mandrels 396 is given as D.sub.1, and the outer surfaces are
centered about axis C.sub.0. The inner surfaces of the mandrels 396
are defined by several arcs. As seen in FIG. 18D, a first inner
surface portion as a radius R.sub.1 centered about axis C.sub.1,
while second portion has radius R.sub.2 centered about axis
C.sub.2.
[0134] The device lumen-forming mandrel 394 includes two
diametrically opposed ribs 398 having a thickness A, and a central
non-uniform convex body defined by several arcs that generally
conform to the inner surfaces of the auxiliary lumen-forming
mandrels 396. More specifically, the exemplary mandrel 394 includes
convex surfaces that are identical in the four quadrants shown and
have a first radius R.sub.3 centered about axis C.sub.3, and a
second radius R.sub.4 centered about axis C.sub.0. A minimum gap
indicated at G.sub.min is defined between the convex outer surfaces
of the device lumen-forming mandrel 394, and the concave inner
surfaces of the auxiliary lumen-forming mandrels 396. The minimum
gap G.sub.min thus forms the thinnest portions of the walls 436 of
the device of the present invention.
[0135] Along the diametric plane that is normal to the diametric
plane through the ribs 398, both extrusion mandrels exhibit a
curvature toward the axis C.sub.0. Namely, the device lumen-forming
mandrel 394 has a concave outer surface portions with the radius
R.sub.5, and both of the auxiliary lumen-forming mandrels 396 have
a convex portion with a radius R.sub.6. The configuration of these
curvilinear portions creates a maximum gap between the mandrels
indicated at G.sub.max. The maximum gap G.sub.max thus forms the
thickest portions of the walls 436. The walls 436 are initially
spaced apart a distance B.
[0136] Exemplary dimensions of the extrusion die and the
corresponding cross-section of the device sheath are given in the
table below:
1TABLE I Extrusion Mandrel Configuration VALUE DIMENSION (in, mm)
D.sub.1 0.325, 8.26 R.sub.1 0.172, 4.37 R.sub.2 0.0956, 2.43
R.sub.3 0.0574, 1.46 R.sub.4 0.1195, 3.04 R.sub.5 0.0382, 0.97
R.sub.6 0.0201, 0.51 A 0.0306, 0.78 B 0.2007, 5.10 G.sub.min
0.0099, 0.25 G.sub.max 0.0182, 0.46
[0137] The dimensions shown in Table 1 are strictly exemplary, and
the multiple-lumen access device of the present invention by no
means is limited to these particular dimensions.
[0138] The resultant cross-section of the sheath after extrusion
through the die 390 is seen in both FIGS. 17 and 18B. The two walls
436 each connect to the outer tube 422 at closely-spaced locations
that are approximately diametrically opposed. The walls 436 bow
away from one another in their relaxed states, with each generally
following the curvature of the outer tube 422 to form therebetween
the auxiliary lumens 428. The device lumen 426 is formed between
the walls 436 which are well-suited to collapsing upon a positive
pressure gradient generated between an auxiliary lumen 428 and the
device lumen. That is, the narrow gaps G.sub.min formed in the
extrusion die create regions in each wall 436 that are weak in
bending. As the pressure differential across the walls 436
increases in favor of the auxiliary lumen 428, the thickest portion
created by the gap G.sub.max tends to be forced inward first
because of the bending of the thinnest portions. If a device is
positioned within the device lumen 426, the walls 436 will contact
it at the thickest portions first. This behavior is shown for a
different sheath cross-section in FIGS. 11A-11C. As a result, the
line contact between the walls 436 and the device facilitates
sliding movement of the device through the sheath. That is, the
walls 436 bend such that a large surface area is prevented from
contacting the device, and thus the frictional resistance to
sliding movement is minimized.
[0139] Alternative MLAD with Valve Insert
[0140] FIGS. 23A and 23B are different perspective angles of an
exemplary multiple lumen access device 500 of the present
invention, which is in many respects very similar to the device 400
shown in FIG. 16. The device 500 includes a junction housing 502, a
distal sheath 504, and a plurality of proximal extension tubes 510
terminating in luer connectors 512. One of the main distinctions
from the earlier described embodiment is the provision of a strain
relief insert 514 positioned at the distal end of the junction
housing 502. In addition, an alternative device valve insert is
provided, but is not seen in FIGS. 23A and 23B and will be
described in detail below. Finally, a plurality of conventional
finger-actuated clamps 516 are mounted on the extension tubes
510.
[0141] FIG. 24 is a side elevational view of the device 500 of FIG.
23 showing the distal sheath 504 inserted through the outer tissue
518 of a patient and into a vessel 520. The flexible nature of the
sheath 504 is seen in this figure, as well as the ability of the
junction housing 502 to live flat against the patient's skin. As
mentioned above, the material used and wall thicknesses for the
outer tube of the sheath 504 are such that the outer tube is a
relatively stiff tube in relation to the inner flexible walls.
Nevertheless, the entire sheath 504 is sufficiently pliable so as
to enable slight bending along its length which facilitates
insertion into the patient's vessel and comfortable placement
against the skin. The soft material used in making the junction
housing 502 further prevents irritation to the patient. In
addition, the strain relief insert 514 is located adjacent the most
extreme bend of the sheath portion 504 and helps prevent kinking of
the internal lumens.
[0142] Alternative Valve Insert
[0143] FIG. 25A is a perspective view of the junction housing 502
with the strain release insert 514 exploded from the distal and,
and components of an alternative device lumen valve insert 522
exploded from the proximal end. The strain relief insert 514 is
additionally shown at a different angle in FIG. 25B. FIGS. 26 and
27 illustrate the components of the alternative valve insert 522 in
greater detail.
[0144] FIGS. 26 and 27 illustrate the alternative device access
valve insert 522 which includes a tactile feedback feature. The
valve insert 522 comprises four components: a clamp 524, wiper 526,
valve 528, and lower outer frame 530. The wiper 526 and valve 528
are juxtaposed within an outer wall 531 of the lower outer frame
530, and held therein by the securement of the clamp 524 onto the
lower outer frame 530 by a pair of latches 532 which engage with
mating lugs 534. The clamp 524 includes a pair of partial threads
536 which cooperate with exterior threads of an infusion catheter
dilator or contamination shield (not shown). A pair of grooves 538
is disposed on a contact face 540 of clamp 524. The wiper 526
includes an aperture 542 through which device catheters may be
inserted in a sealed fashion. The valve 528 may be a conventional
duck-billed valve having a valve slit, as seen at 464 in FIG. 22.
As described previously in regards to the device valve insert 418
shown in FIGS. 21 and 22, the combination of the wiper 526 and the
valve 528 effectively seals the device channel formed within the
junction housing and the exterior of the junction housing when
devices are repeatedly introduced and withdrawn through the valve
insert 522.
[0145] The upper portion of the valve insert 522 is relatively
rigid and may be formed from the same material as the lower outer
frame 530 such as acrylic, polysulfone, or other high durometer
materials. It is also noted that the valve insert 522 shown in FIG.
26 may be used for the exemplary multi-lumen access devices shown
in FIGS. 1, 6, and 16.
[0146] Contamination Shield Adapter
[0147] FIGS. 28A and 28B illustrate an adapter 550 for a distal end
of a contamination shield. The adapter 550 includes threads 552
which mate with the threads 536 of the upper portion of the valve
insert 532 illustrated in FIGS. 26 and 27. The threads 552 of the
adapter 550 are designed to fully engage with the threads 536 of
the clamp 524 by a 1/4 turn of the adapter 550. A pair of lugs 554
are disposed on the contacting surface 556 of the adapter 550 such
that the lugs 554 mate with the pair of grooves 538 of the clamp
524. As the 1/4 turn is completed, the lugs 554 snap into the
grooves 538 and create a tactile feedback. The contamination shield
550 sealingly receives a flexible tubular sheath thereover to
provide a sterile channel that is alternately collapsible and
extensible around devices inserted through the device valve. Such
contamination shields are well known in the art and will not be
further described.
[0148] Strain Relief Insert
[0149] A multiple lumen access device may kink at the multi-lumen
sheath/junction housing interface when the access device is
attached to a patient. The kink may reduce the cross-sectional area
of the multi-lumen sheath or in extreme circumstances, result in
blockage of the lumens. The "kink" problem may be resolved by
providing a multiple lumen access device with the strain relief
insert 514 as illustrated in FIGS. 23A, 23B, 24, and 25A. Again,
the access device 500 is similar to the access device described in
FIG. 16 with the exception that the junction housing 502 is
modified to accept the strain relief insert 514. The strain relief
insert 514 is connected to the distal end of the junction housing
502, and over the multi-lumen sheath 504.
[0150] The strain relief insert 514 has an oval cross-section
tapering gradually wider along its long axis from the multi-lumen
sheath 504 to the junction housing 502. As seen in FIG. 25A, the
low profile lumen portion 578 of the junction housing 502 also has
an oval cross-section tapering gradually wider along its long axis
from the strain relief insert 514 to a proximal face 580 to which
the extension tubes (not shown) connect. The strain relief insert
514 includes a tapered body 582 having ribs 584 which gradually
blend into the body. These ribs 584 allow the strain relief insert
514 to flex and prevent the multiple-lumen sheath 504 from
kinking.
[0151] In order to achieve the desired flexibility of the strain
relief insert 514, it is preferred that a relatively soft, elastic
material be utilized. Suitable elastic materials include, but are
not limited to, polyurethane and pellathane with a 55D shore
hardness. Further, in order to achieve the desired flexibility, the
thickness of the strain relief insert 514 must be carefully matched
to the particular material being utilized. For less flexible
materials, the wall thickness should be correspondingly reduced in
order to achieve the desired flexibility limits. The strain relief
insert 514 may be formed using radio frequency (RF) technology with
appropriate forming dies and fixtures. Desirably, the strain relief
insert 514 is overmolded onto the sheath 504 and subsequently
coupled to the junction housing 502 at the time that the housing
and sheath are connected.
[0152] MLADS with Remote Introducer Valves
[0153] FIGS. 29 and 30 illustrate a further embodiment of the
multiple lumen access device 600 in which the device access valve
602 is not formed integrally with the junction housing 604. More
particularly, as best seen in FIG. 29, the junction housing 604 has
a low profile which is slightly greater than the sheath 606 or
extension tubes 608 attached thereto. FIG. 31 shows a proximal end
of low profile junction housing 604 illustrating three channels 610
formed therein for communication with three extension tubes 612,
seen in FIG. 30. A central extension tube 612 connects with a
remote introducer valve 614 which has a proximal opening 616 for
device catheter access. Within the introducer valve 614, a number
of different duck-bill or other valves may be provided to seal the
lumen of the extension tube 612 from the exterior. Introducer valve
614 may include a side port extension tube 618 terminating in a
luer lumen hub 619 for attaching to infusion fluid sources. Thus,
in this alternative configuration, a single needle stick followed
by implantation of the multi-lumen sheath 606 is all that is
required to obtain the benefits of both an introducer valve and
central venous catheter, as described previously. Alternatively,
the multiple lumen access device 600 further includes an auxiliary
lumen valve connected to at least one other extension tube 612 than
the central tube to therefore provide a valved entry to at least
one of the auxiliary lumens within the sheath 606 as well as with
the device lumen.
[0154] In a further alternative of the device 600, FIG. 32
illustrates a multiple lumen access device 620 wherein the central
extension tube 622 terminates in a luer connector 624. The luer
connector 624 is desirably used to mate with a female luer
connector 626 of an introducer valve assembly 628. However, in this
detachable configuration, various other medical devices having
conventional luer fittings may be attached to the luer connector
624 and placed in communication with a central lumen of the
multi-lumen sheath 630. FIG. 33 illustrates a further alternative,
wherein the introducer valve assembly 632 is provided with a male
luer connector 634 on a proximal end to which an infusion syringe
636 may be attached. As can be seen, various configurations are
possible with the remote introducer valve assembly 628, and the low
profile junction housing 621 is easily molded over the extension
tubes and has a reduced size, thus facilitating the manufacturing
process.
[0155] MLAD with Multi-lumen Catheter and/or Introducer
Combination
[0156] FIG. 34 illustrates a further alternative multiple lumen
access device 650 comprising a multi-lumen infusion catheter 652 in
combination with a conventional single-lumen introducer valve 654.
The multi-lumen infusion catheter 652 includes a junction housing
656 which interfaces a plurality of proximal extension tubes 658
and a multi-lumen sheath 660 extending distally therefrom. FIG. 36
illustrates one way in which the proximal extension tubes 658 can
be routed to communicate with a plurality of tubes 662 providing
lumens of the multi-lumen sheath 660. The multi-lumen sheath 660 is
sized to fit through the introducer valve 654 having a distal
sheath 664, and from there into the body. In this manner, a
single-lumen introducer may be implanted into the patient and then
used further as an access port for the multi-lumen infusion
catheter 652. By leaving the introducer in place, only a single
stick is necessary to enjoy both introducer and central venous
catheter capabilities.
[0157] With specific reference to FIG. 36, a proximal insert 666,
and a distal insert 668 are mounted around the array of extension
tubes 658, and distal tubes 662, respectively. The housing 656 is
then formed by injection molding material around and between the
inserts 666 and 668. A valve seal expander 670 may be provided to
help keep the duck-bill valve within the introducer valve 654 open.
Further, locking threads 672 are preferably provided to interface
with the introducer valve housing 654.
[0158] FIGS. 35A-D show various configurations of the multi-lumen
sheath 660. In FIG. 35A, a three-lumen solid configuration having a
larger high-pressure lumen 674 is shown. FIG. 35B illustrates a
four-lumen embodiment which has an outer sheath 680 so that fluid
may be passed between the sheath and the exterior of the four tubes
within. FIG. 35C is similar to the four-lumen sheath of FIG. 35B,
but includes a single large lumen 682 and a plurality of smaller
lumens 684. Finally, FIG. 35D illustrates an arrangement of lumens
having a central high-volume high-pressure lumen 686, and a
plurality of smaller lumens 688 attached around the circumference
in an even array.
[0159] FIGS. 37 and 38 illustrate a further embodiment of a
multi-lumen sheath 690 having a central, high-pressure tube 692 and
a plurality of outer or auxiliary tubes 694.
[0160] MLAD with Multiple Discrete Tubes
[0161] FIG. 39 illustrates a multi-lumen catheter device 700 having
at least two discrete catheter tubes. In this embodiment, the
multi-lumen catheter device 700 includes a main (or center) lumen
tube 702 and two side lumen tubes 704. The lumen tubes 702 and 704
are configured in a side-by-side fashion, and proximal portions of
the tubes 702, 704 are peeled apart to create sidearms. Hubs 706
may be attached to proximal ends of each lumen tube 702, 704 for
fluid delivery or introduction of a medical device. Remote
introducer valves may be connected to one or all the lumen tubes.
Indeed, the device valves may be provided on any or all of the
extension tubes for the various embodiments described herein and
shown in any of the figures, including FIGS. 1, 6, 23A, 30. The
catheter device 700 may further include a sleeve 708 at the region
where the lumen tubes 702 and 704 branch outwardly. FIGS. 40A and
40B illustrate the different cross-section of the device 700, the
circular shape of the sleeve providing a smooth transition for
sealing through a puncture wound into the skin. One of the
advantages of this embodiment is that one or more of the lumen
tubes 702 and 704 may be peeled off the multi-lumen catheter 700 if
desired.
[0162] FIG. 41 illustrates another alternative multi-lumen catheter
device 710. This catheter device 710 is similar to the catheter
device 700 illustrated in FIG. 39 and includes the additional
feature of a junction housing 712 connected to a proximal end of a
main lumen tube 714. The junction housing 712 receives a valve
insert 716 and an extension tube 718 with a hub 720 connected to
its proximal end. Again, the separate tubes can be peeled away to
create various lumen devices.
[0163] Multiple Lumen Catheter through Introducer
[0164] FIGS. 42A and 42B illustrate a multi-function adapter 730
for connecting different components, for example, catheters and
introducers, for use with the present invention. The multi-function
adapter include a first unit and a second unit that are
complementary and enable a quick-release connection of a multiple
lumen device and an introducer. By way of example and not
limitation, the multi-function adapter may include a female unit
730a and a male unit 730b. The male unit 730b includes at least one
lug 732 extending radially outward, while the female unit 730a
includes a slot (not illustrated) which accepts and interlocks with
the lug. The slot may be a variety of configurations to securely
interlock the male unit with the female unit, such as an L-shaped
channel, a bayonet lock, an interference fit, etc. Other types of
adapters known in the art such as luers may be utilized as long as
components of the access device can be easily
connected/disconnected.
[0165] In the embodiment of FIGS. 42A and 42B, the adapter 730
couples a multiple lumen catheter 734 with an introducer 735. The
catheter 734 may be a CCO catheter or other multiple-lumen device,
and includes a junction housing 736 between a distal multi-lumen
sheath 738 and a plurality of proximal extension tubes 740. The
introducer 735 includes a hub 742 with a side arm 744 for
introducing or withdrawing fluids. The female unit 730a is adapted
to fit over the sheath 738 by a press fit, adhesive, or any other
means generally known in the art. Conversely, the male unit may be
fixedly attached to the sheath 738 or distal end of the junction
housing 736 instead of the female unit, if desired. The adapter 730
permits detachability of the multiple lumen catheter 734 from the
introducer 735 and provides great flexibility in surgical or
critical care situations.
[0166] FIGS. 43A and 43B illustrate a multiple-lumen access device
760 very similar to the device of FIGS. 42A and 42B but with the
adapter formed as part of a multiple lumen catheter junction
housing. The access device 760 includes an introducer 762 connected
to a Central Venous Catheter (CVC) or other multiple lumen catheter
764 by a multi-function adapter 766a and 766b. The catheter 764
includes a multiple-lumen sheath 768 connected to a junction
housing 770.
[0167] The access device 760 (and the device of FIGS. 42) offers a
significant advantage over current catheter designs in terms of
cost saving and manner in which the access device 760 may be
utilized. Currently, an introducer is inserted into a vein, and a
surgical procedure is performed. After the surgical procedure, the
introducer is usually removed and a new catheter is inserted in the
vein through a second puncture and sutured onto the skin. The
patient is then transported to a recovery room. By using the access
device 760 of the present invention illustrated in FIG. 43, the
procedure can be greatly simplified. The introducer 762 is first
positioned in the vessel using traditional methods, such as the
Seldinger technique. After the introducer 762 is used for sampling
or infusing fluids, multiple lumen catheter 764 is inserted and
utilized. The catheter 764 can then be detached from the introducer
762 and removed from the vessel while the introducer 762 is left in
the vessel, and the introducer 762 now functions as a catheter.
Thus, after the surgical procedure, the introducer 762 does not
have to be removed from the vessel and a new catheter does not have
to be inserted through a second puncture.
[0168] FIGS. 44A and 44B illustrate a multiple lumen access device
780 having an introducer 782 connected to a triple lumen junction
housing 784 by a multi-function adapter 786a and 786b. Instead of
the elongated sheath as in the previous two embodiments, the
junction housing 784 includes a short hollow obturator 788 that
serves to hold open a hemostasis valve in a hub 790 of the
introducer 782. The three lumens within the junction housing 784
communicate with the lumen of the obturator 788 to deliver fluids
to the introducer lumen.
[0169] FIGS. 45A and 45B illustrate an access device 820 having a
single lumen introducer 822 connected to a multiple lumen junction
housing 824 by a threaded female adapter 826 and male luer
connection 828. A device valve 830 in the junction housing 824
permits insertion of various devices into a vessel via the
introducer 822 at the same time that various fluids are infused
through extension tubes 832.
[0170] FIGS. 46A and 46B illustrate an access device 840 similar to
the access device 820 illustrated in FIG. 45 and includes the
additional feature of a small diameter catheter tube 842 extending
from a distal end of a junction housing 844. The catheter tube 842
functions as an infusion lumen for one of the extension tubes 846,
while the space between the catheter tube 842 and a single lumen
introducer 848 functions as a device lumen. Again, the junction
housing 844 is attached to the introducer 848 with a threaded
adapter 850.
[0171] Introducer Within Introducer Combination
[0172] A multiple lumen access to the body through a single patient
entrance site may also be accomplished by using a plurality of
elongated sheaths and implements, such as introducers, obturators
or catheters, inserted coaxially within each other to form multiple
independent lumens. FIGS. 47A and 47B, for example, illustrate a
multi-lumen access device 860 comprising a first single-lumen
introducer 862 telescopically received within a second single-lumen
introducer 864. The first introducer 862 includes a single lumen
sheath 866 having an opening 868 at its distal end and connected to
an introducer valve housing 870 at its proximal end. Within the
introducer valve housing, a duck-billed valve or other appropriate
valves may be provided to seal the lumen from the exterior. The
introducer valve housing 870 may include a side port extension tube
872 terminating in a hub 874 for attaching to infusion fluid
sources. The second elongated implement, for example, an introducer
864 includes a single lumen sheath 876 connected to the distal end
of an introducer valve housing 878. The introducer valve housing
878 also may include a side port extension tube 880 terminating in
a hub 882 for attaching to infusion fluid sources, and the sheath
876 may include an opening 884 towards a distal end thereof to
allow exit of fluid which has been introduced through the side port
extension tube 880.
[0173] As shown in FIG. 47B, the sheath 866 of the first introducer
862 is sized to fit coaxially through the introducer valve 878 and
lumen of the second introducer 864. The distal opening 868 of the
first introducer sheath 866 may extend beyond the distal end of the
second introducer sheath 876. In addition, at least one of the
lumens formed by the placement of introducer 862 coaxially within
the introducer 864 is capable of passing a supplemental catheter.
By way of example and not limitation, one such catheter has an
outside diameter sized about 4 French or more. In one exemplary
application of FIG. 47B, fluid 1 (for example, medicine 1) may be
introduced through the hub 882 and may exit the device through the
opening 884 while fluid 2 (for example, medicine 2) may be
introduced through the hub 874 and exit the device through the
opening 868. Alternatively, the fit between the smaller sheath 866
and larger sheath 876 may be somewhat loose at the distal end so
that fluid introduced the hub 882 may pass through an annular space
formed therebetween, and through the opening 884, as indicated by
the arrows 886. Both introducers 862 and 864 include male luer
connectors 888 on their proximal ends for connecting to a variety
of medical implements, including the threaded adapters for
attaching multiple lumen catheters as previously described.
[0174] The access device 860 offers a significant advantage over
known introducers by providing multiple lumen access with only a
single patient entrance site. Currently, two introducers are
usually inserted into the patient at two different sites if another
independent lumen is required. The access device 860 of the present
invention allows the flexibility to start a procedure with only one
introducer 864, and if another independent lumen is required, an
additional introducer 862 can be inserted into the introducer 864.
It is noted that the access device is not limited to two
introducers. For example, a combination of three or more
introducers may be coaxially configured if additional independent
lumens are required.
[0175] Also, as will be understood by those skilled in the art, at
least one of the single lumen introducers that is coaxially
inserted into another single lumen introducer may be made from a
flexible deformable material. As a result, the wall forming the
sheath of such insertable introducer will also form at least one of
the multiple lumens and will be movable upon differential changes
in pressure across the wall. This follows from the principles
described earlier with respect to extruded multiple lumen sheaths,
including the descriptions related to FIGS. 3A-B, 11A-C, 12 and 17.
For instance, the larger introducer sheath 876 may be rigid, while
the smaller introducer sheath 866 may be flexible or pliable. If a
large amount of fluid is infused through larger introducer hub 882,
the space around the smaller sheath 866 experiences and increase in
pressure and the sheath may buckle inward to accommodate the larger
flow. In one embodiment, a portion of the inside introducer may be
rigid and some portion may be flexible, for example only the distal
tip of the smaller introducer is rigid to permit insertion through
the larger introducer.
[0176] MLADS Formed with Obturators within Introducers
[0177] Another alternative embodiment of the present invention
forms multi-lumen access device by a combination of a single lumen
catheter or introducer with a solid or hollow obturator. FIGS. 48A
and 48B illustrate a multi-lumen access device 900 comprising an
elongated implement, for example a multi-channel obturator 902,
inserted into single lumen sheath or catheter 904. The obturator
902 includes a sheath 906 having a device lumen 908 and, in one
preferred embodiment, three evenly circumferentially arranged
longitudinal ribs 910 extending radially from a proximal end to a
distal end of the sheath 906. Any number of the radially extending
ribs is within the scope of the present invention. Similarly, the
ribs does not have to be arranged evenly circumferentially. A
hemostasis valve 912 (within housing) is connected to the proximal
end of the sheath 906. The catheter 904 includes a single lumen
sheath 914 connected to a hemostasis valve 916 (within housing)
with three access ports 918 for infusion of fluids.
[0178] When the obturator 902 is inserted into the catheter 904, as
shown in FIG. 48B, the ribs 910 contact the inner wall of the
catheter sheath 914 and form three (or any other desired number)
auxiliary lumens 920. Each auxiliary lumen 920 communicates with
the corresponding access port 918 of the catheter 904. To provide a
liquid tight seal at the interface between the ribs 910 and inner
wall of the catheter sheath 914, the obturator sheath 906 is made
from a sufficiently rigid material and is sufficiently sized while
the catheter sheath 914 is made from a sufficiently resilient
material. Thus, the access device 900 has multiple independent
fluid entries and multiple independent lumens. In addition, the
obturator may be used as a fluid delivery lumen by having an
obturator without a hemostasis valve. The multi-lumen access device
900 should have at least two auxiliary lumens 920, and preferably
three, though other numbers of lumens are also within the scope of
the present invention.
[0179] One of the advantages of the access device 900 over known
introducer products is that it provides greater flexibility of use
and eliminates the need for a central venous catheter (CVC). The
prior art introducer is inserted into the patient; and if another
independent lumen is required, a CVC is usually inserted into the
patient. By using the access device 900, the catheter 904 is
inserted into the patient and if another independent lumen is
required as well as a device lumen, the obturator 902 may be
inserted into the catheter 904 to achieve multi-lumen access with
only one patient entrance site.
[0180] FIG. 49 illustrates another multi-lumen access device 930
which is similar to the access device 900 shown in FIGS. 48A and
48B with the exception that an obturator 932 has two access ports
936 for infusion of fluids, and a single lumen catheter 934 has
only one access port 938. This arrangement allows all or some of
the fluid to be introduced via the obturator 932 instead of the
catheter 934. The remaining elements of the access device 930 are
not discussed because they are essentially the same as the elements
shown in FIGS. 48A and 48B.
[0181] A further alternative MLAD using a solid obturator or solid
elongated implement is shown in FIGS. 50A and 50B. In this
embodiment, a single lumen catheter or introducer 950 is converted
to a multiple lumen access device 952 upon combination with an
obturator 954. Obturator 954 comprises a proximal hub 956 and an
elongated trefoil portion 958 that closely fits within a sheath 960
of the introducer 950. Three exemplary auxiliary lumens 962 are
thus formed within the sheath 960. Three infusion ports 964 provide
access to the lumens 962, and any one of the them may be adapted to
introduce a device through the introducer 950.
[0182] FIGS. 51-54 illustrate a still further MLAD embodiment
formed using an obturator within an introducer. Specifically, a
MLAD 970 is formed by the combination of a hollow obturator 972
with an introducer 974. The obturator includes a proximal hub 976
and a distal tube 978 having a plurality of outwardly directed ribs
980. A distal plug member 982 has a diameter the same as the rubs
980. The obturator 972 defines a hollow through bore extending
through the proximal hub 976 and distal tube 978. The introducer
974 includes a proximal hub 986 and distal sheath 988, and also
defines a hollow bore therethrough that transitions from a larger
proximal diameter to a smaller distal diameter at a step 990. The
sheath 988 has a tapered distal tip 992 and an outlet port 994 in
one side. A fluid infusion port 996 is provided in the hub 986.
[0183] The distal tube 978 closely within the sheath 988, as seen
in FIG. 52, until the plug member 982 abuts the internal step 990.
The ribs 980 seal against the interior of the bore of the sheath
988 and thus three sealed fluid flow channels are formed between
the obturator 972 and introducer 974. Either multiple outlet ports
994 may be provided, one for each channel, of the obturator may be
rotated to place one of the three channels into communication with
a single outlet port. Devices or other implements can be inserted
through the bore 984 while fluid is infused through the channels.
Another difference between this embodiment and those previously
described is the provision of the tapered distal tip 992 on the
introducer 974 that facilitates insertion over a dilator and into a
vessel.
[0184] Having thus described exemplary embodiments of the present
invention, it should be noted by those skilled in the art that the
disclosures herein are exemplary only and that various other
alternations, adaptations and modifications may be made within the
scope of the present invention. Accordingly, the present invention
is not limited to the specific embodiments as illustrated
herein.
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