U.S. patent application number 09/769052 was filed with the patent office on 2002-07-25 for multi-lumen catheter with attachable hub.
Invention is credited to Boyd, Ronald D., Cassidy, Kenneth T., Fleming, Carl M., Fleming, Gary S., Wilson, Jon S..
Application Number | 20020099326 09/769052 |
Document ID | / |
Family ID | 25084289 |
Filed Date | 2002-07-25 |
United States Patent
Application |
20020099326 |
Kind Code |
A1 |
Wilson, Jon S. ; et
al. |
July 25, 2002 |
Multi-lumen catheter with attachable hub
Abstract
The present invention is a multi-lumen catheter assembly having
an selectively attachable hub including a multi-lumen catheter tube
that has a proximal portion and a distal portion and a hub assembly
that has a proximal portion and a distal portion, whereby the
distal portion of the catheter tube is selectively attachable to
the proximal portion of the hub assembly after subcutaneous
insertion of the proximal portion of the catheter tube into a
patient.
Inventors: |
Wilson, Jon S.;
(Winston-Salem, NC) ; Fleming, Carl M.; (Palm
City, FL) ; Cassidy, Kenneth T.; (Mocksville, NC)
; Boyd, Ronald D.; (Statesboro, GA) ; Fleming,
Gary S.; (Palm City, FL) |
Correspondence
Address: |
RHODES & MASON, P.L.L.C.
300 N. Greene Street
1600 First Union Tower
Greensboro
NC
27402
US
|
Family ID: |
25084289 |
Appl. No.: |
09/769052 |
Filed: |
January 24, 2001 |
Current U.S.
Class: |
604/43 |
Current CPC
Class: |
A61M 2025/0037 20130101;
A61M 2025/0034 20130101; A61M 1/16 20130101; A61M 25/0097 20130101;
A61M 2025/0031 20130101; A61M 25/0029 20130101; A61M 2025/0098
20130101; A61M 1/3659 20140204; A61M 25/0028 20130101; A61M 1/3653
20130101 |
Class at
Publication: |
604/43 |
International
Class: |
A61M 003/00; A61M
025/00 |
Claims
What is claimed is:
1. A multi-lumen catheter assembly having an selectively attachable
hub, comprising: a multi-lumen catheter tube having a proximal
portion and a distal portion; and a hub assembly having a proximal
portion and a distal portion, wherein the distal portion of the
catheter tube is selectively attachable to the proximal portion of
the hub assembly after subcutaneous insertion of the proximal
portion of the catheter tube into a patient.
2. The multi-lumen catheter assembly of claim 1, wherein the
catheter tube has a first lumen and a second lumen, and wherein the
hub assembly is further comprised of: a first cannula and a second
cannula, wherein each of the cannulae has a proximal portion and a
distal portion, the proximal portion of the first cannula being
connectable with the first lumen of the catheter tube, and the
proximal portion of the second cannula being connectable with the
second lumen of the catheter tube, to provide for fluid
communication therebetween; a first extension tube and a second
extension tube, wherein each of the extension tubes has a proximal
portion and a distal portion, and wherein the proximal portion of
the first extension tube is connectable with the distal portion of
the first cannula, and the proximal portion of the second extension
tube is connectable with the distal portion of the second cannula,
to provide fluid communication therebetween; and a first connector
and a second connector, the first connector being securely attached
to the distal portion of the first extension tube and the second
connector being securely attached to the distal portion of the
second extension tube, wherein each of the connectors are
attachable to a fluid conveying device to provide fluid flow
between the hub assembly and the catheter tube.
3. The multi-lumen catheter assembly of claim 2, wherein the
proximal portion of each of the first and second cannulae have a
generally D-shaped cross-section and the distal portion of each of
the first and second cannulae have a generally O-shaped
cross-section.
4. The multi-lumen catheter assembly of claim 3, wherein the
proximal portions of each of the extension tubes have a generally
O-shaped cross-section and are configured to receive the distal
portion of a respective cannulae.
5. The hub assembly of claim 2 further comprising: a hub body
formed about the connection between the proximal portion of each
extension tube with the distal portion of each cannula.
6. The multi-lumen catheter assembly of claim 5, further
comprising: a connection cover having a proximal portion and a
distal portion, wherein the cover fits axially about the distal
portion of the catheter tube; and a compression sleeve, the
compression sleeve fitting axially about the distal portion of the
catheter tube and the proximal portion of the first and second
cannulae; wherein the distal end of the cover is selectively
connectable to the hub assembly.
7. The multi-lumen catheter assembly of claim 6, wherein the hub
body has a proximal portion and a distal portion, the proximal
portion of the hub body being selectively attachable to the distal
portion of the connection cover, such that the catheter tube is
securely attached to the hub assembly.
8. The multi-lumen catheter of claim 2, wherein the angle between
the first cannula and the second cannula is about 15 degrees.
9. The multi-lumen catheter of claim 1, wherein the proximal
portion of the catheter tube further comprises a first and second
lumen, each of the first and second lumens having a generally
D-shaped cross-section, wherein each of the first and second lumens
transition toward the distal portion of the catheter tube into a
single lumen having a longitudinally extending septum.
10. The multi-lumen catheter of claim 2, wherein a first indicator
is associated with a first lumen, the first cannula, and the first
connector; and a second indicator is associated with a second
lumen, the second cannula, and the second connector; such that the
first indicator and the second indicator define a matching
correspondence between the lumens, the cannulae, and the
connectors.
11. A multi-lumen catheter assembly having a selectively attachable
hub, comprising: a) a multi-lumen catheter tube having a proximal
portion and a distal portion and a first lumen and a second lumen;
and b) a hub assembly, the hub assembly further comprising: i) a
first cannula and a second cannula, wherein each of the cannulae
has a proximal portion of D-shaped cross-section and a distal
portion of O-shaped cross-section, the proximal portion of the
first cannula being connectable with the first lumen of the
catheter tube, and the proximal portion of the second cannula being
connectable with the second lumen of the catheter tube, to provide
for fluid communication therebetween; ii) a first extension tube
and a second extension tube, wherein each of the extension tubes
has a proximal portion and a distal portion, and wherein the
proximal portion of the first extension tube has an O-shaped
cross-section and is connectable with the distal portion of the
first cannula, and the proximal portion of the second extension
tube has an O-shaped cross-section and is connectable with the
distal portion of the second cannula, to provide fluid
communication therebetween; iii) a first connector and a second
connector, the first connector being securely attached to the
distal portion of the first extension tube and the second connector
being securely attached to the distal portion of the second
extension tube; and iv) a hub body having a proximal portion and a
distal portion, the hub body being formed about the connection
between the proximal portions of each of the first and second
extension tubes with the distal portions of each of the first and
second cannulae, respectively; v) a first indicator is associated
with a first lumen, the first cannula, and the first connector; and
a second indicator is associated with a second lumen, the second
cannula, and the second connector, such that the first indicator
and the second indicator define a matching correspondence between
the lumens, the cannulae, and the connectors; c) a connection cover
having a proximal portion and a distal portion, wherein the cover
fits axially about the distal portion of the catheter tube; and d)
a compression sleeve, the compression sleeve fitting axially about
the distal portion of the catheter tube and the proximal portion of
the first and second cannulae; wherein the proximal portion of the
hub body being selectively attachable to the distal portion of the
connection cover, such that the catheter tube is selectively
attachable to the hub assembly after insertion of the proximal
portion of the catheter tube into a patient.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to medical
instrumentation and more specifically to a multi-lumen catheter
with a selectively attachable hub assembly that allows the catheter
tip to be positioned accurately prior to subcutaneous
tunneling.
BACKGROUND OF THE INVENTION
[0002] Catheters, generally, are hollow, flexible tubes for
insertion into a body cavity, duct, or vessel to allow the passage
of fluids or distend a passageway. Catheters are often used for
temporary or long-term dialysis treatment. Dialysis treatment
provides for blood to be withdrawn from the patient, purified, and
then returned to the patient. Thus, in dialysis treatment,
catheters are used to allow passage of a patient's blood into and
out of the patient's body. For optimal performance during dialysis
treatment, the catheter tips, both in-flow and outflow, should be
placed in close proximity to the heart. Typically, medical
personnel use either a double lumen catheter or two single lumen
catheters. Both types, however, present certain deficiencies.
[0003] While double lumen catheters (e.g., U.S. Pat. No. 4,895,561)
allow for a single venous insertion of the catheter into the
desired vein, double lumen catheters typically do not provide for
accuracy of catheter tip placement. Due to differences among
patients, optimal tip position varies from patient to patient.
Non-optimal tip position may significantly lower flow values,
resulting in less effective dialysis treatment. For current double
lumen catheters, a physician must make an estimate regarding the
appropriate catheter tube length prior to beginning the procedure
of catheterization. Then, a subcutaneous tunnel is made from the
preferred end position of the hub assembly, namely, away from the
neck of the patient in order to allow for more convenient access to
the dialysis treatment equipment. The double lumen catheter tube is
then tunneled forwardly into the patient's vein. The initial
estimate and subsequent forward tunneling may result in less than
optimal tip placement.
[0004] With the use of two independent catheters (e.g., U.S. Pat.
Nos. 5,776,111 and 5,624,413) the problem of tip placement is
addressed. The hub assembly of each catheter is removable from the
tube and tip portion of the catheter, thereby allowing the catheter
tip to be placed directly into the vein and advanced into the
desired position. Then, the proximal end of the catheter can be
reversed tunneled and trimmed to a desired length. Thereafter, the
hub assembly is attached. Deficiencies, however, exist in this
method of catheterization as well. One problem associated with this
method is that this method requires two separate venous insertions,
namely, two tunnels and two of each accessory instrument used for
the procedure. Therefore, there is increased surgical time required
to place two catheters, there are two wound entry sites which
doubles the risk of post-surgical infection, and the two catheters
together are significantly larger in diameter than one double lumen
catheter.
SUMMARY OF THE INVENTION
[0005] The present invention is a double lumen catheter with a
selectively detachable hub assembly that allows the catheter tip to
be positioned accurately within a patient's vein prior to
subcutaneous tunneling. The distal end of the catheter tube is not
permanently attached to the hub assembly. Therefore, the catheter
may be reverse tunneled after the tips have been positioned.
[0006] The hub assembly includes at least two cannulae that
coordinate and correspond to the at least two lumen at the distal
end of the catheter tube. Once the hub assembly is connected to the
catheter tube so as to provide fluid communication therebetween,
preferably, a connection cover and a malleable compression sleeve
are secured into place. Preferably, the connection cover is
threaded to mate with a threaded connection on the hub assembly.
The connection cover and the compression sleeve together create
force to prevent inadvertent separation of the catheter tube from
the hub assembly.
[0007] These and other aspects of the present invention as
disclosed herein will become apparent to those skilled in the art
after a reading of the following description of the preferred
embodiments and drawings. The description and drawings are for the
purpose of describing a preferred embodiment of the invention and
are not intended to limit the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is an exploded, perspective view of a multi-lumen
catheter assembly of the present invention.
[0009] FIG. 2 is an enlarged, exploded, perspective view of a hub
assembly of the multi-lumen catheter assembly of the present
invention, including a first cross-sectional view of the hub
body.
[0010] FIG. 3 is an enlarged, exploded, perspective view of the hub
assembly and distal portion of a catheter tube of the present
invention, including the first cross-sectional view of the hub
body.
[0011] FIG. 4 is a first cross-sectional view of the catheter tube
of the multi-lumen catheter of the present invention.
[0012] FIG. 5 is an enlarged perspective view of the catheter tube
of the present invention.
[0013] FIG. 6 is a perspective view of an assembled multi-lumen
catheter assembly of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0014] As shown in the Figures, the present invention is a
multi-lumen catheter assembly 10 having a selectively attachable
hub assembly 20. As shown in FIG. 1, a multi-lumen catheter tube 12
is formed with a proximal portion 12a and a distal portion 12b. The
distal portion 12b of the catheter tube 12 is selectively
attachable to the proximal portion 20a of the hub assembly 20. In
this manner, the hub assembly 20 may be attached to the catheter
tube 12 after insertion of the proximal portion 12a of the catheter
tube, including tips 14 and 16, into a patient.
[0015] As illustrated in FIG. 2, preferably, the hub assembly 20
has a first cannula 22 and a second cannula 24. Each of the
cannulae has a proximal portion 22a and 24a, respectively, and a
distal portion 22b and 24b, respectively. Further, each cannulae 22
and 24 has an associated extension tube, 26 and 28 respectively.
Each of the extension tubes 26 and 28 has a proximal portion 26a
and 28a, respectively, and a distal portion 26b and 28b,
respectively. Each of the extension tubes 26 and 28 are in fluid
communication with the first cannula 22 and second cannula 24,
respectively, through appropriate connection of respective proximal
and distal portions, namely connection of the cannulae distal
portions 22b and 24b with extension tube proximal portions 26a and
28a, respectively. While the drawings depict the hub assembly with
two cannulae, any appropriate configuration and number of cannulae
should be considered within the scope of the present invention.
[0016] As shown in FIG. 2, preferably, the hub body 21 is formed to
maintain the angle A between the first extension tube 26 and the
second extension tube 28 at about 15 degrees. This angle is
preferred based upon the necessity for connecting the catheter
assembly 10 to the fluid conveying device, e.g., dialysis
equipment.
[0017] Returning to FIG. 1, the hub assembly 20 further includes a
first connector 30 and a second connector 32. The connectors 30, 32
may be luer fittings, as are known in the art. The first connector
30 is securely attached to the distal portion of the first
extension tube 26b and the second connector 32 is securely attached
to the distal portion of the second extension tube 28b. Each of the
connectors 30, 32 preferably is attachable to a fluid conveying
device (not shown), such as dialysis equipment, as is known in the
art. Thus, the respective cannulae 22 and 24 are in fluid
communication with extension tubes 26 and 28, respectively.
Therefore, the cannulae 22, 24 provide for respective in-flow and
out-flow operation of the fluid conveying device.
[0018] Each extension tube 26 and 28 has a clamp, 42 and 44,
respectively, for clamping the extension tubes 26 and 28 when the
catheter assembly 10 is not connected to a fluid conveying
device.
[0019] The hub body 21 has two suture wings 38 and 40, which can be
used to suture the catheter assembly 10 to the patient to maintain
the position of the catheter assembly 10 after insertion into the
patient.
[0020] As shown in FIG. 3, the hub assembly 20 preferably is formed
such that each proximal end of the cannulae 22a and 24a has a
generally D-shaped cross-section. Preferably, the distal portion of
each of the cannulae 22b and 24b has a generally O-shaped
cross-section. As such, preferably, the proximal portions 26a and
28a of each of the extension tubes 26 and 28a have a generally
O-shaped cross-section and are configured to receive the distal
portions 22b and 24b of the respective first and second cannulae 22
and 24. The shape and cross-section configuration of the cannulae
22, 24 the extension tubes 26, 28 and the lumens 13, 17 of the
catheter tube 12, may be varied, and, thus, the scope of the
present invention should not be limited to the above-described
preferred configuration.
[0021] Preferably, a hub body 21 is formed around the proximal
portions of each of the extension tubes and the distal portions of
each of the cannulae. As illustrated in FIG. 2, the hub body 21
provides for protection against disconnection of the several
connections between cannulae 22, 24 and extension tubes 26, 28.
Further, the hub body 21 provides a structure for connection with
the catheter tube 12. More specifically, hub body 21 has a proximal
portion 21a and a distal portion 21b. As previously mentioned, the
hub body 21 is selectively attachable to the distal portion 12b of
the catheter tube 12 so as to provide fluid communication between
the respective cannulae 22 and 24 (via proximal portions of the
cannula 22a and 24a) with the lumens 13 and 17, respectively, of
the catheter tube 12, which is discussed in more detail below.
[0022] As shown in FIG. 5, the catheter tube 12 has a first lumen
13 and second lumen 17. Each of the first and second lumen 13, 17
has a generally D-shaped cross-section. A longitudinally extending
septum 15 defines each lumen 13, 17 up through the distal portion
of the catheter tube 12b, as shown in FIG. 4. Therefore, each lumen
13, 17 connects to a respective cannula 22, 24 for fluid
communication therewith.
[0023] Preferably, each lumen 13, 17 of the distal portion 12b of
the catheter tube 12, and the proximal ends 22a and 24a of the
cannulae 22 and 24 are correspondingly marked by an indicator, such
as a color, to ensure proper matched correspondence upon
connection. To further ensure matched correspondence, preferably
tips 14, 16, extension tubes 26, 28 and connectors 30, 32 follow
the same marking pattern. Thus, for example, tip 14, the lumen 13,
cannula 22, extension tube 26, and connector 30 are marked with a
first indicator (e.g., the color blue), while tip 16, lumen 17,
cannula 24, extension tube 28, and connector 32 are marked with a
second indicator (e.g., the color red). Thus, the first indicator
is associated with one of the lumens and a second indicator is
associated with the other lumen, such that the first indicator and
the second indicator define a correspondence between that lumen and
an associated cannula, extension tube, and connector. While the
indicator may be a visual indicator such as color, a selectively
attachable multi-lumen catheter with any indicator, visual,
tactile, or otherwise, should be considered within the scope of the
invention.
[0024] As described above, the invention is described with a
preferred embodiment containing two cannulae and a dual-lumen
catheter. The present invention should not be limited, however, to
this preferred embodiment and other appropriate configurations
should be considered within the scope of the present invention. For
example, the catheter tube and corresponding cannulae may be a
series of concentric tubes of varying diameter. Alternatively, the
assembly 10 may provide a similar configuration to that described
hereinabove with three (or more) cannulae and a triple (or more)
lumen catheter tube. The preferred embodiment, however, includes
two cannulae with a dual-lumen catheter tube.
[0025] Preferably, as shown in FIG. 3, the connection between the
proximal portions 22a, 24a of the cannulae 22, 24 and the lumens 13
and 17 at the distal portion 12b of the catheter tube 12 is an
overlapping fitted connection. However, any other appropriate
fastening means, such as detents may be used.
[0026] Returning to FIG. 1, an example of a preferred connection
between hub body 21 and catheter tube 12 is shown, which includes a
connection cover 34 having a proximal portion 34a and a distal
portion 34b. Connection cover 34 should fit axially about the
distal portion 12b of the catheter tube 12. The distal end 34b of
the connection cover 34 is appropriately threaded such that the
connection cover 34 is selectively attachable to the threaded
portion 21a of the hub body 21 such that the catheter tube 12 is
securely attached to the hub assembly 20. For example, as
illustrated in FIG. 1, the connection cover 34 may include female
threads to selectively receive the male threads 21 a formed on hub
body 21.
[0027] Preferably, the present invention also includes a
compression sleeve 36 that fits axially about the distal portion
12b of the catheter tube 12 as well as fitting axially about the
combined proximal portions 22a and 24a of the first and second
cannulae 22 and 24. Compression sleeve 36 preferably is formed of
malleable material so as to provide further compression about the
connection between the cannulae 22 and 24 with the multi-lumen
catheter tube 12. The connection cover 34 and the compression
sleeve 36 together create force to prevent inadvertent separation
of the catheter tube 12 from the hub body 21 after insertion of the
catheter tube 12 into a patient.
[0028] FIG. 6 shows the catheter assembly 10 of the present
invention with the hub assembly 20 attached to the catheter tube
12.
[0029] A preferred method for inserting into a patient the catheter
assembly 10 of the present invention requires the following: a
multi-lumen catheter tube 12 with, preferably, tapered silicone
tips 14, 16, and, as are known in the art, an introducer needle,
multiple tear away sheath dilator introducers, J-flex guidewires,
trocars, lock right adapters with clamps, injection caps, a
scalpel, sutures, and adhesive wound dressing. Additionally, the
physician should have access to scissors, forceps, needles dish,
syringes and gauzes.
[0030] A preferred method for insertion of the catheter of the
present invention into a patient's jugular vein begins with placing
the patient in a position with the patient's head turned to the
opposite side of where the jugular vein is to be cannulated. The
anatomical landmark for proper insertion is defined by the triangle
formed by the lateral edge of the sternal head, the medial edge of
the clavicular head of the sternocleidomastoid muscle, and the
upper edge of the clavicle.
[0031] The patient's neck and a portion of the patient's thorax
beneath the clavicle, preferably at least about 20 centimeters
(cm), should be appropriately prepared for incision. Thereafter,
the patient should be draped and local anesthetic should be
administered.
[0032] Preferably, a skin wheel should be created, taking care to
infiltrate the subcutaneous tissue for about 2 to 3 cm. Next,
preferably with an 18-gauge needle attached to a syringe, the
physician should identify the internal jugular vein by aspiration
and then proceed at an angle while continuing to aspirate with the
syringe. Once the internal jugular vein has been located, the
preferred method includes detaching the syringe while leaving the
needle in place. The needle opening should then be occlused and
thereafter the J-flex guidewire should be introduced through the
needle and into the internal jugular vein. The guidewire should
pass without resistance into the exact position. The needle should
be removed, thus leaving the guidewire in place. The guidewire
should rest at the junction of the superior vena cava and the right
atrium. Appropriate guidewire placement can be confirmed with
fluoroscopy.
[0033] Next, with a scalpel, the physician should make an incision
in the skin that is wide enough for the catheter tube 12 to pass. A
tearaway sheath dilator may be introduced over the guidewire and
into the vein far enough to dilate the vessel. After expanding the
vein wall, the guidewire may be removed while occluding the dilator
opening. A trocar should be screwed onto the catheter tube 12 by
turning the trocar clockwise, but not the catheter tube 12. Turning
the catheter tube 12 may cause it to kink. The dilator may be
removed, leaving the tearaway sheath in place to introduce the
catheter tube 12, again being careful to occlude the sheath
opening. As the catheter tube 12 is fed into the sheath the
tearaway sheath may be torn away. Care should be taken that the
catheter tube 12 does not back out of the vessel.
[0034] Air embolus is avoided by the patient's positioning
described above, and also by asking the patient to inhale deeply
and then hold their breath. At this point, fluoroscopy should be
performed to confirm catheter tube 12 placement. The tip 14 of the
venus catheter should reach the opening of the right atrium and the
tip 16 of the arterial catheter should be approximately 4 cm
higher. As described above, proper positioning is important.
Positioning, as described, is believed to prevent blood
recirculation during hemodialysis.
[0035] Next, a tunnel, of about 8 to 10 cm, should be created in a
caudal and internal direction by means of the tunneler, which may
be shaped to physician preference. The catheter tube 12 should be
gently pulled through the tunnel until the loop at the original
puncture site is gone. When correctly inserted, the catheter tube
12 should rest over the clavicle. Care should be taken to avoid
excessive force, as this may cause the catheter tube 12 to separate
from the tunnel. Preferably, the method includes surveying this
area to ensure there are no kinks in the catheter tube 12 and there
is a smooth turn.
[0036] Next, while pinching the distal portion 12b of the catheter
tube 12, the hub assembly 20 is attached to the catheter tube 12.
The connector 34 is backfit over the catheter tube 12. Next, the
compression sleeve 36 is backfit over the catheter tube 12. The
proximal portions 22a, 24a of cannulae 22, 24 are inserted into
lumens 13 and 17, respectively, creating a friction fit.
Preferably, the cannulae 22, 24, or the corresponding extension
tubes 26, 28 or the corresponding connectors 30, 32 are marked so
that the cannulae 22, 24 are inserted into the correct lumens 13,
17.
[0037] After backbiting the connector cover 34 and the compression
sleeve 36 over the catheter tube 12, the compression sleeve 36 is
slid into a position that is approximately adjacent to the threaded
portion 21a of the hub body 21. Finally, the connector cover 34 is
attached to the hub body 21 by turning the connector cover 34 so
that the female threaded portion of the connector cover 34 receives
the male threaded portion 21a of the hub body 21 thereby creating a
secure attachment of the hub assembly 20 to the catheter tube 12.
Clamps 42, 44 may be used with extension tubes 26, 28.
[0038] The extension tubes 26, 28 should be filled with 3 to 4 cc
of 5000 units of heperinized saline, clamped, and attached with the
injection cap. X-rays should again be performed to reconfirm
placement. The small incision is closed with sutures. The patient
is now ready for dialysis.
[0039] Preferably, the catheter tube 12 is formed with radioopaque
silicone, to facilitate visualization under fluoroscopy.
[0040] Although specific embodiments of the present invention have
been illustrated and described in detail, it is to be expressly
understood that the invention is not limited thereto. The above
detailed description of the embodiment is provided for example only
and should not be construed as constituting any limitation of the
invention. Modifications will be obvious to those skilled in the
art, and all modifications that do not depart from the spirit of
the invention are intended to be included within the scope of the
appended claims.
* * * * *