U.S. patent application number 15/728456 was filed with the patent office on 2018-10-04 for adjustable-length dual-lumen hemodialysis catheter and a method for its use.
The applicant listed for this patent is Mark Steven Fisher, Kenneth M. Zinn. Invention is credited to Mark Steven Fisher, Kenneth M. Zinn.
Application Number | 20180280679 15/728456 |
Document ID | / |
Family ID | 50826116 |
Filed Date | 2018-10-04 |
United States Patent
Application |
20180280679 |
Kind Code |
A1 |
Zinn; Kenneth M. ; et
al. |
October 4, 2018 |
ADJUSTABLE-LENGTH DUAL-LUMEN HEMODIALYSIS CATHETER AND A METHOD FOR
ITS USE
Abstract
The present adjustable-length dual-lumen hemodialysis catheter
can eliminate the need to stock various lengths of hemodialysis
catheters and can provide a hemodialysis catheter, which can be
trimmed to various lengths in order to precisely accommodate
patients of various shapes and sizes. Specifically, the present
adjustable-length dual-lumen hemodialysis catheter can comprise a
cuff ring assembly, which can be secured at selected locations
along the trailing limbs of the catheter allowing the cuff ring
assembly to be installed in a location chosen to precisely fit a
particular patient.
Inventors: |
Zinn; Kenneth M.; (Westport,
CT) ; Fisher; Mark Steven; (Sellersville,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Zinn; Kenneth M.
Fisher; Mark Steven |
Westport
Sellersville |
CT
PA |
US
US |
|
|
Family ID: |
50826116 |
Appl. No.: |
15/728456 |
Filed: |
October 9, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13691988 |
Dec 3, 2012 |
9782575 |
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15728456 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/0247 20130101;
A61M 2039/087 20130101; A61M 2039/0258 20130101; A61M 39/1011
20130101; A61M 25/0097 20130101; A61M 2039/0273 20130101; A61M
2039/0261 20130101; A61M 2025/0031 20130101; A61M 2025/0286
20130101; A61M 1/3661 20140204; A61M 2039/0282 20130101 |
International
Class: |
A61M 39/10 20060101
A61M039/10; A61M 25/00 20060101 A61M025/00; A61M 39/02 20060101
A61M039/02; A61M 1/36 20060101 A61M001/36 |
Claims
1. A method for using a dual-lumen hemodialysis catheter apparatus,
comprising: providing a dual-lumen hemodialysis catheter apparatus
comprising: a dual-lumen hemodialysis catheter comprising a distal
end and a proximal end, wherein the proximal end comprises a first
trailing limb and a second trailing limb; providing a cuff ring
assembly further comprising a cuff ring comprising a hollow tube
having a bottom end and a top end, wherein the bottom end comprises
a first opening and the top end comprises a second opening and the
cuff ring is configured to allow the proximal end of the dual-lumen
hemodialysis catheter to pass into the cuff ring through the first
opening and exit from the cuff ring through the second opening,
wherein the top end of the cuff ring further comprises a locking
section configured to receive a cuff ring wedge through the second
opening, and wherein the cuff ring wedge is configured to be
connected within the locking section; at least one suture wing
connected to the cuff ring; at least one hub assembly; and a cuff
configured to be placed over the bottom end of the cuff ring; using
a tunneler to retrograde tunneling the dual-lumen hemodialysis
catheter apparatus into a large vein in a patient's upper torso
using and extending the proximal end of the dual-lumen hemodialysis
catheter from an incision made in a patient's chest using a
scalpel; placing the cuff ring assembly over the proximal end of
the dual-lumen hemodialysis catheter by threading the proximal end
of the hemodialysis catheter into the first opening located at the
bottom of the cuff ring and out from the second opening located at
the top of the cuff ring; splitting the first trailing limb from
the second trailing limb down to a selected point along at the
proximal end of the dual-lumen hemodialysis catheter; placing the
cuff ring wedge between the first trailing limb and the second
trailing limb and into the locking section of the cuff ring through
the second opening at the top of the cuff ring; connecting the cuff
ring wedge to the locking section of the cuff ring assembly;
placing the cuff subcutaneously within the patient; connecting at
least one suture wing to the patient; and trimming the first
trailing limb to a selected length and trimming the second trailing
limb to a selected length.
2. The method described in claim 1 wherein the distal end of the
dual-lumen hemodialysis catheter apparatus comprises a
split-tip.
3. The method as described in claim 1 wherein the distal end of the
dual-lumen hemodialysis catheter apparatus comprises a
step-tip.
4. The method as recited in claim 1 wherein the cuff ring wedge of
the dual-lumen hemodialysis catheter apparatus creates a first limb
opening located between the cuff ring wedge and the locking section
when connected within the locking section, which is configured to
allow the first trailing limb to pass through the first limb
opening, and wherein the first trailing limb is secured to the cuff
ring when it is placed within the first limb opening and the cuff
ring wedge is connected to the locking section.
5. The method as recited in claim 1 wherein the cuff ring wedge of
the dual-lumen hemodialysis catheter apparatus creates a second
limb opening located between the cuff ring wedge and the locking
section when connected within the locking section, which is
configured to allow the second trailing limb to pass through the
second limb opening, and wherein the second trailing limb is
secured to the cuff ring when it is placed within the second limb
opening and the cuff ring wedge is connected to the locking
section.
6. The method as recited in claim 4 wherein both the first limb
opening and the first trailing limb are D-shaped.
7. The method as recited in claim 5 wherein both the second limb
opening and the second trailing limb are D-shaped.
8. The method described in claim 1 wherein at least one hub
assembly is connected to at least one trailing limb of the
dual-lumen hemodialysis catheter.
Description
FIELD OF THE INVENTION
[0001] The present general inventive concept is directed toward a
dual-lumen catheter apparatus such as those commonly used to
perform hemodialysis.
BACKGROUND
[0002] Catheters are tubes used in the medical field to be inserted
into a patient allowing for the drainage of, or administration of
fluids and medicines. Specifically, dual-lumen hemodialysis
catheters are a class of catheter, which can be used to exchange
blood to and from a hemodialysis machine and a patient suffering
from renal failure. These catheters are typically placed in a large
vein of a patient, usually the jugular vein, and advanced down
toward the chest in a retrograde insertion or tunneled through the
subcutaneous tissue of the upper chest and into a large vein in an
antegrade insertion. Current hemodialysis catheters can be split at
their distal ends, and these catheters are referred to as
`split-tip catheters.` The free-floating ends of such catheters can
provide better flow rates and prevent clogging of the catheter.
Existing hemodialysis catheters are secured to the patient through
a fixed hub and suture wing assembly, intended to reduce the risk
of accidental dislodgement from the patient. In order to install
these catheter correctly, they must be manufactured in various
lengths to adequately fit the dimensions of patients of various
shapes and sizes, which requires hospitals and clinics to stock
various lengths of hemodialysis catheters. Keeping such an
inventory can be both costly and difficult to maintain.
[0003] What is needed is an adjustable-length hemodialysis
catheter, which can be adapted to fit nearly any patient,
regardless of that patient's size or shape, thus eliminating the
need for hospitals or other healthcare facilities to stock multiple
lengths of hemodialysis catheters.
SUMMARY OF THE INVENTION
[0004] It is an aspect of the present device to provide an improved
dual-lumen hemodialysis catheter that can be manually adjusted to a
desired length to fit an individual patient's particular size and
shape. It is another aspect of the present device to provide a
method for placing and properly installing this improved
hemodialysis catheter into a patient.
[0005] This aspect can be obtained by a dual-lumen hemodialysis
catheter apparatus comprising: a cuff ring assembly comprising: a
cuff ring further comprising a locking section comprising at least
one cuff ring wedge-mounting hole; a cuff ring wedge comprising at
least one cuff ring wedge peg configured to be securely connected
within the locking section; a cuff; and a dual-lumen hemodialysis
catheter comprising a first end and a second end, wherein the
second end comprises two trailing limbs.
[0006] These together with other aspects and advantages, which will
be subsequently apparent, reside in the details of construction and
operation as more fully hereinafter described and claimed,
reference being had to the accompanying drawings forming a part
hereof, wherein like numerals refer to like parts throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] Further features and advantages of the present device, as
well as the structure and operation of various embodiments of the
present device, will become apparent and more readily appreciated
from the following description of the preferred embodiments, taken
in conjunction with the accompanying drawings of which:
[0008] FIG. 1A is a top view drawing of a cuff ring assembly and
the proximal end of a dual-lumen hemodialysis catheter, according
to an embodiment;
[0009] FIG. 1B is a cross-sectional view of the proximal end of a
dual-lumen hemodialysis catheter.
[0010] FIG. 2 is a top view drawing of a cuff ring assembly,
wherein two trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter have been threaded through the cuff ring
assembly, according to an embodiment;
[0011] FIG. 3 is a top view drawing of a cuff ring assembly,
wherein two trailing limbs of the dual-lumen hemodialysis catheter
have been threaded through the cuff ring assembly, and the two
trailing limbs have been split apart to a selected location along
the dual-lumen hemodialysis catheter, according to an
embodiment;
[0012] FIG. 4 is a top view drawing of a cuff ring assembly,
wherein two trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter have been threaded through the cuff ring
assembly, and the two trailing limbs have been split apart to a
selected location (not visible in FIG. 4) and this location is
located within the locking section of the cuff ring assembly,
according to an embodiment;
[0013] FIG. 5A is a top view drawing of a cuff ring assembly,
wherein two trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter have been threaded through the cuff ring
assembly, and the two trailing limbs have been split apart to a
selected location (not visible in FIG. 5A) and this location is
located within the locking section of the cuff ring assembly and a
cuff ring wedge has been placed near the top end of the locking
section and between the trailing limbs at the location, according
to an embodiment;
[0014] FIG. 5B is a perspective view drawing showing the top, front
and side of a cuff ring wedge, according to an embodiment;
[0015] FIG. 6 is a top view drawing of a cuff ring assembly,
wherein two trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter have been threaded through the cuff ring
assembly, and the two trailing limbs have been split apart to a
selected location (not visible in FIG. 6) and this location is
located within the locking section of the cuff ring assembly and a
cuff ring wedge (not visible in FIG. 6) has been placed into the
top end of the locking section and between the trailing limbs at
the location, thus securing the two trailing limbs to the cuff ring
assembly, according to an embodiment;
[0016] FIG. 7A is a rear view drawing of a cuff ring assembly not
comprising a cuff ring wedge, according to an embodiment;
[0017] FIG. 7B is a rear view drawing of a cuff ring assembly
wherein a cuff ring wedge has been connected to the locking
section, according to an embodiment;
[0018] FIG. 8 is a perspective view drawing showing the rear, top
and side of a cuff ring assembly, not comprising a cuff ring wedge,
according to an embodiment;
[0019] FIG. 9 is a top view drawing of a cuff ring assembly,
wherein two trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter have been threaded through the cuff ring
assembly, and the two trailing limbs have been split apart to a
selected location (not visible in FIG. 9) and this location is
located within the locking section of the cuff ring assembly and a
cuff ring wedge (not visible in FIG. 9) has been placed into the
top end of the locking section and between the trailing limbs at
the location, thus securing the two trailing limbs to the cuff ring
assembly, and wherein the two trailing limbs have been trimmed to
the proper length and hub assemblies have been connected to each
trailing limb, according to an embodiment;
[0020] FIG. 10A is a top view drawing of a patient's upper torso,
wherein the trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter extend from an incision in the patient's
chest located at one end of a subcutaneous tunnel (not visible in
FIG. 10A), according to an embodiment.
[0021] FIG. 10B is a top view drawing of a patient's upper torso,
wherein the trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter extend from an incision in the patient's
chest and the trailing limbs have been threaded through the cuff
ring assembly so that the trailing limbs extend through a top end
of the cuff ring assembly and a cuff has been used to close the
incision over a bottom end of the cuff ring assembly and the cuff
has been positioned within a subcutaneous tunnel (not visible in
FIG. 10B), according to an embodiment;
[0022] FIG. 10C is a top view drawing of a patient's upper torso,
wherein the trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter extend from an incision in the patient's
chest and the trailing limbs have been threaded through the cuff
ring assembly so that the trailing limbs extend through a top end
of the cuff ring assembly and a cuff has been used to close the
incision over a bottom end of the cuff ring assembly and the cuff
has been positioned within a subcutaneous tunnel (not visible in
FIG. 10C) and the trailing limbs have been split apart down to a
selected position within the cuff ring assembly, according to an
embodiment; and
[0023] FIG. 10D is a top view drawing of a patient's upper torso,
wherein the trailing limbs of the proximal end of a dual-lumen
hemodialysis catheter extend from an incision in the patient's
chest and the trailing limbs have been threaded through the cuff
ring assembly so that the trailing limbs extend through a top end
of the cuff ring assembly and a cuff has been used to close the
incision over a bottom end of the cuff ring assembly and its
trailing limbs have been split apart down to a selected position
within the cuff ring assembly and a cuff ring wedge has been
connected to the cuff ring assembly to secure the trailing limbs to
the cuff ring assembly, and a hub assembly has been connected to
each trailing limb, according to an embodiment.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] This description of the exemplary embodiments is intended to
be read in connection with the accompanying drawings, which are to
be considered part of the entire written description. In the
description, relative terms such as "lower," "upper," "horizontal,"
"vertical,", "above," "below," "up," "down," "top" and "bottom" as
well as derivatives thereof (e.g., "horizontally," "downwardly,"
"upwardly," etc.) should be construed to refer to the orientation
as then described or as shown in the drawing under discussion.
These relative terms are for convenience of description and do not
require that the apparatus be constructed or operated in a
particular orientation. Terms concerning attachments, coupling and
the like, such as "connected" and "interconnected," refer to a
relationship wherein structures are secured or attached to one
another either directly or indirectly through intervening
structures, as well as both movable or rigid attachments or
relationships, unless expressly described otherwise.
[0025] Reference will now be made in detail to the presently
preferred embodiments of the invention, examples of which are
illustrated in the accompanying drawings, wherein like reference
numerals refer to like elements throughout.
[0026] The present concept relates to dual-lumen hemodialysis
catheters having lengths that can be adjusted to fit patients of
various sizes and dimensions. More specifically, the present
concept relates to a dual-lumen hemodialysis catheter comprising an
adjustable cuff ring assembly, which can be used to adjust the
length of the proximal end of the catheter. The present catheter
can comprise a distal end, or leading end, and a proximal end, or
trailing limb, wherein the leading end can be placed within a large
vein in the patient and the trailing limb can extend outside the
patient, typically through an incision in the patient's chest. The
leading end can comprise a step-tip design, a split-tip design, a
spiral-z tip design or any other suitable leading end comprising a
dual-lumen catheter. However, the split-tip design may be currently
preferable over the step-tip design because openings in the
intravascular portion of the split-tip design have been shown to be
less prone to clogging than those comprising the step-tip
design.
[0027] The present catheter can comprise a segment of permanent
adhesion, between its leading end and its trailing limb, wherein
one half of the dual-lumen catheter cannot be split apart from the
other half, thus preventing the limbs of the catheter from being
split completely into two individual catheters. In an embodiment,
the two limbs comprising the catheter can each be D-shaped, wherein
a flat side of the D of a first limb can connect to a flat side of
the D of a second limb and a cross-section of the two limbs
together can form either the shape of a circle or oval. However,
any other suitable shape of catheter limbs can also be used.
[0028] In an embodiment, the present dual-lumen hemodialysis
catheter can comprise a cuff ring assembly configured to secure the
varying lengths of the trailing limbs of the catheter to the cuff
ring assembly and can also be configured to allow the cuff ring
assembly to be securely connected to a patient. This cuff ring
assembly can comprise a cuff ring, which can be a hollow tube
having a first opening at a bottom end and a second opening at a
top end. This cuff ring can be configured to allow the trailing
limbs of the catheter to be placed through the cuff ring by
threading the trailing limbs in through the first opening and out
through the second opening. The bottom end of the cuff ring can be
tapered to allow it to be inserted into an incision in the
patient's chest through which the trailing limbs of the catheter
have been extended. In an embodiment, one or more suture wings can
extend from one or more sides of the cuff ring, wherein each suture
wing can be used to secure the cuff ring and the entire cuff ring
assembly externally to a patient's body by suturing each suture
wing to the patient's skin. In an embodiment, the cuff ring
assembly can also comprise a cuff, made from a material such as
Dacron, which can be configured to slide over the tapered bottom
end of the cuff ring. In an embodiment, this cuff can be placed
manually along the cuff ring so that a patient's subcutaneous
tissue can be allowed to grow into the cuff, enabling the catheter
to be secured inside the patient's body and the risk of infection
can thus be reduced.
[0029] In an embodiment, the present device can also comprise a
cuff ring wedge that can be inserted into the top end of the cuff
ring comprising the cuff ring assembly. This cuff ring wedge can be
placed between the two trailing limbs of the dual-lumen catheter,
pressing each trailing limb against an inner surface of the cuff
ring, thus locking each trailing limb into a fixed position
relative to the cuff ring. In an embodiment, the top end of the
cuff ring can be configured to contain the cuff ring wedge along
with both trailing limbs and the top end of the cuff ring can be
configured to securely connect the cuff ring wedge into the second
opening of the cuff ring. Although the cuff ring wedge is shown as
having only flat sides, the shape of the cuff ring wedge can be
configured to secure various shapes of catheters to the cuff ring.
After the trailing limbs of the dual-lumen catheter have been
securely connected to the cuff ring, each of the trailing limbs can
be trimmed to any desired length and hub assemblies, comprising
clamps and hubs, can be connected to each of the trailing limbs of
the catheter.
[0030] In an embodiment, the present device can be used in
conjunction with a method wherein the leading end of the catheter
can be positioned within a large vein in a patient, usually the
aorta or superior vena cava, and the trailing limb can then be
retrograde tunneled back through a subcutaneous tract and emerge
from a skin exit site, typically located on the surface of the
patient's chest. The trailing limb of the catheter can be split
down to a selected location, which can ordinarily be located one
(1) to two (2) centimeters within the subcutaneous tunnel. The
trailing limbs of a dual-lumen catheter can be threaded through the
cuff ring assembly, including at least one suture wing, until the
suture wings are located adjacent to the skin exit site. The manual
positioning of the cuff ring assembly can allow the cuff ring to be
placed subcutaneously over the dual-lumen catheter at an
appropriate selected location within the patient. The cuff can be
placed so as to allow subcutaneous tissue to grow into the cuff,
thus facilitating the proper connection of the catheter to the
patient's skin at the exit site. The suture wing can allow the cuff
ring assembly to be secured to the patient's skin with sutures at a
chosen location. Each suture wing can restrict movement of the cuff
ring assembly relative to the patient. The trailing limbs of the
dual-lumen catheter can then be trimmed to a desired length to
accommodate the patient's size and dimensions, allowing for an
adjustable-length dual-lumen hemodialysis catheter. Finally,
protective clamps and hub locks can be attached to the trailing
limbs of the dual-lumen hemodialysis catheter according to standard
practice.
[0031] In an embodiment, a ribbed cuff ring wedge can be inserted
into the cuff ring, between the two trailing limbs, and can be
secured within the top end of the cuff ring by connecting to it.
The cuff ring wedge can lock the trailing limbs in place, thus
reducing risk of entanglement and dislodgement of the catheter from
the patient.
[0032] In an embodiment, the present cuff ring can be made from a
soft material that can prevent the splitting of the catheter if
tension is applied to the catheter. In an embodiment, the present
cuff ring wedge can be made of a material, which can be slightly
harder than the material comprising the cuff ring that can act to
lock the trailing limbs of the catheter in place. The softer
material comprising the cuff ring can also be configured to stretch
in order to accommodate the insertion of the harder wedge, into the
cuff ring.
[0033] FIG. 1A is a top view drawing of a cuff ring assembly 100
and the proximal end of a dual-lumen hemodialysis catheter 101,
according to an embodiment.
[0034] In an embodiment, a cuff ring assembly 100, as depicted in
FIG. 1A, can comprise a hollow, cylindrical tube, referred to as a
cuff ring 120, comprising a bottom end 110 and a top end 111,
wherein the cuff ring 120 near the bottom end 110 can be tapered so
that its circumference and width is smallest at the bottom end 110,
and the top end 111 can comprise a wider locking section 102. One
or more suture wings 103 can be connected to sides 115 near the top
end 111 of the cuff ring 120. In an embodiment, one or more suture
wings 103 can comprise a cuff ring 120 made from a single piece of
material. The cuff ring assembly 100 can be manually installed in a
desired location on a patient so as to place the bottom end 110 of
the cuff ring 120 and a cuff 130 into a subcutaneous tunnel (not
shown in FIG. 1) within the patient. The suture wing 103 can be
placed externally near the exit site of the subcutaneous tunnel
(not shown in FIG. 1A), and trailing limbs 160 and 161 of the
proximal end of the dual-lumen hemodialysis catheter 101 can be
placed through the bottom end 110 of the cuff ring 120. The cuff
ring 120 can comprise a hollow, cylindrical tube having a locking
section 102 comprising an enlarged opening at the top end 111. In
an embodiment, the locking section 102 can also comprise a first
cuff ring wedge-mounting hole 125 located near the top end 111 of
the cuff ring 120. In an embodiment, a second cuff ring
wedge-mounting hole (not visible in FIG. 1A) can be located
opposite the first cuff ring wedge-mounting hole 125 and can be
used to connect a cuff ring wedge (not shown in FIG. 1A) to the
cuff ring 120.
[0035] FIG. 1B is a cross-sectional view of the trailing limbs 160
and 161 of a dual-lumen hemodialysis catheter 101.
[0036] Each of the trailing limbs depicted in FIG. 1B are D-shaped,
but the present invention can be configured to be used with limbs
of various shapes and sizes. In an embodiment a flat side 165
comprising trailing limb 160 can be removably connected to flat
side 166 comprising trailing limb 161, wherein each limb can be
initially connected to the other, but can be configured to be
easily pulled apart (separated) without damaging either limb 160 or
161.
[0037] FIG. 2 is a top view drawing of a cuff ring assembly 100,
wherein two trailing limbs 160 and 161 of the proximal end of the
dual-lumen hemodialysis catheter 101 have been threaded through the
cuff ring assembly 100, according to an embodiment.
[0038] In an embodiment, the trailing limbs 160 and 161 of a
dual-lumen hemodialysis catheter 101 can be threaded through the
cuff ring 120 by placing the tips 119 of the trailing limbs 160 and
161 into the cuff ring 120 through the bottom end 110 first then
out through the top end 111 of the cuff ring 120. The cuff ring
assembly 100 can be moved over the trailing limbs 160 and 161 of
the proximal end of the dual-lumen hemodialysis catheter 101 until
the bottom end 110 of the cuff ring 120, can be inserted into the
exit site and into the subcutaneous tunnel (not shown in FIG.
2).
[0039] In an embodiment, each suture wing 103 can be a wing-shaped
protrusion on either side 115 of the cuff ring 120 near the top end
111 and the suture wing 103 can be placed on either side 115 of the
cuff ring 120. The suture wing 103 can also comprise one or more
suture wing holes 231, which can be located at the outermost end
232 of each suture wing 103 according to an embodiment. These
suture wing holes 231 can be used to secure the cuff ring 120 to a
patient's skin, and into the subcutaneous tunnel, at a desired
location near the exit site of the subcutaneous tunnel using
sutures (the patient, the exit site and the sutures are not shown
in FIG. 2).
[0040] FIG. 3 is a top view drawing of a cuff ring assembly 100,
wherein two trailing limbs 160 and 161 of the proximal end of the
dual-lumen hemodialysis catheter 101 have been threaded through the
cuff ring assembly 100, and the two trailing limbs 160 and 161 have
been split apart to a selected location 301 along the dual-lumen
hemodialysis catheter 101, according to an embodiment.
[0041] In an embodiment, the cuff 130 can be placed at a desired
location under a patient's skin (not shown in FIG. 3), and the
suture wings 103 can be used to secure the cuff ring assembly 100
externally to the patient's skin, near the exit site of the
subcutaneous tunnel (not shown in FIG. 3). The cuff ring assembly
100 can comprise a cuff 130, which can be a hollow ring made from a
plastic material, or a similar suitable material known to those
skilled in the art of medical devices. This cuff 130 can be placed
subcutaneously into the patient (not shown in FIG. 3) so as to
secure the proximal end of the dual-lumen hemodialysis catheter 101
into the subcutaneous tissue by permitting tissue ingrowth around
its entire circumference, which also adds a barrier to
infection.
[0042] FIG. 4 is a top view drawing of a cuff ring assembly 100,
wherein two trailing limbs 160 and 161 of the proximal end of the
dual-lumen hemodialysis catheter 101 have been threaded through the
cuff ring assembly 100, and the two trailing limbs 160 and 161 have
been split apart to a selected location (not visible in FIG. 4) and
this location is located within the locking section 102 of the cuff
ring assembly, according to an embodiment.
[0043] In an embodiment, the selected location 301 where the
trailing limbs 160 and 161 are split apart can be located just
inside the top end 111 of the locking section 102 of the cuff ring
assembly 100. This selected location 301 can also be located one
(1) to two (2) centimeters inside the subcutaneous tunnel (not
shown in FIG. 4). The ability to adjust the position of this
selected location 301 to many different locations along the
proximal end of the dual-lumen hemodialysis catheter 101 can allow
for the precise placement of the cuff ring assembly 100 in relation
to the proximal end of the dual-lumen hemodialysis catheter 101.
The trailing limbs 160 and 161 are initially connected together but
the trailing limbs 160 and 161 can be separated manually. As will
become apparent, this aspect of the present device can allow the
dual-lumen hemodialysis catheter 101 to be very finely adjusted to
fit patients of a wide variety of sizes and shapes, thus ensuring a
proper fit while maintaining proximal tip location at the desired
position.
[0044] FIG. 5A is a top view drawing of a cuff ring assembly 100,
wherein two trailing limbs 160 and 161 of the proximal end of a
dual-lumen hemodialysis catheter 101 have been threaded through the
cuff ring assembly 100, and the two trailing limbs 160 and 161 have
been split apart to a selected location (not visible in FIG. 5A)
and this location is located within the locking section 102 of the
cuff ring assembly 100 and a cuff ring wedge 555 has been placed
near the top end 111 of the locking section 102 and between the
trailing limbs 160 and 161 at the selected location, according to
an embodiment. The cuff ring wedge 555 has two pegs 535 and 545
(see FIG. 5B) configured to connect the cuff ring wedge 555 to the
locking section 102.
[0045] In an embodiment, the cuff ring wedge 555 can be inserted
into the top end 111 of the locking section 102 and securely
connected to, and within, the locking section 102 by placing at
least one cuff ring wedge peg 535 into a first cuff ring
wedge-mounting hole 125, and preferably each cuff ring peg, 535 and
545, can be placed in into each cuff ring wedge-mounting hole, 125
and 126, (A second cuff ring wedge-mounting hole 126 can be viewed
in FIG. 8.). Although only a peg and hole system for securely
connecting the cuff ring wedge 555 to the locking section 102 is
shown in the attached figures, the cuff ring wedge 555 can be
similarly connected to the cuff ring 120 using any number of
alternative suitable connecting devices known in the art (e.g.,
friction fit, snap, etc.) One function of the cuff ring wedge 555
is to secure each of the trailing limbs 160 and 161 of the
dual-lumen hemodialysis catheter 101 to the locking section 102 of
the cuff ring 120 by pressing the trailing limbs 160 and 161
against inner walls (not visible in FIG. 5A) of the locking section
102.
[0046] In an embodiment, the first cuff ring peg 535, comprising
the cuff ring wedge 555, can be configured to fit within the first
cuff ring wedge-mounting hole 125 in the cuff ring 120 and the
first cuff ring peg 535 can snap into the first cuff ring
wedge-mounting hole 125 to secure the cuff ring wedge 555 into the
locking section 102 of the cuff ring 120. The second cuff ring peg
545 (not visible in FIG. 5A) can also snap into the second cuff
ring wedge-mounting hole 126 (not visible in FIG. 5A). The cuff
ring wedge 555 can be located between the two trailing limbs 160
and 161 of the catheter, allowing the trailing limbs 160 and 161 to
each extend out separately from the top end 111 of the cuff ring
assembly 100. The cuff ring wedge 555 can securely connect the two
trailing limbs 160 and 161 to the cuff ring assembly 100 so that
they are held apart, making them less likely to become tangled.
[0047] FIG. 5B is a perspective view drawing showing the top, front
and side of a cuff ring wedge 555, according to an embodiment.
[0048] In an embodiment, the cuff ring wedge 555 can be
wedge-shaped, comprising a top triangular flat side 521, having a
narrow front end 534 and a wide back end 536, and a bottom
triangular flat side (not visible in FIG. 5B), also having a narrow
front end and a wide back end, identical to the top triangular flat
side 521. The cuff ring wedge 555 can also comprise a first tapered
side 525, having a first end 540 and a second end 541 and a second
tapered side (only partially visible in FIG. 5B but appears
identical to the first tapered side 525) opposite the first tapered
side 525, also having a first end and a second end (not visible in
FIG. 5B). Wherein, the first end 540 of the first tapered side 525
and the first end of the second tapered side can connect to form a
blade end 560 of the cuff ring wedge 555, having a top blade side
565 and a bottom blade side 566 and the narrow front end 534 of the
top triangular flat side 521 can be connected to the top blade side
565 and the bottom triangular flat side can be connected to the
bottom blade side 566. In an embodiment, the cuff ring wedge can
also comprise a back side 590 (not visible in FIG. 5B, but visible
in FIG. 7B) which can be flat, the back side 590 being opposite the
blade side 560 and can connect to the wide back end 536 of the top
triangular flat side 521 and the wide back end (not visible in FIG.
5B) of the bottom triangular flat side (not visible in FIG. 5B) as
well as the second end 541 of the first tapered side 525 and the
second end of the second tapered side (not visible in FIG. 5B but
can be structured identically to the first tapered side 525). In an
embodiment, the outer surface of the first tapered side 525 and the
outer surface of the second tapered side can comprise ribs, barbs
530 or other surface designs configured to increase friction, which
can allow the cuff ring wedge 555 to more effectively grip the
trailing limbs 160 and 161 of the dual-lumen hemodialysis catheter
101.
[0049] In an embodiment, a first peg 535 can be connected to the
top triangular flat side 521 and a second peg 545, which can be
identical to first peg 535, can be connected to the bottom
triangular flat side (not visible in FIG. 5B but looks identical to
top triangular flat side 521) opposite the first peg 535. As
mentioned above, the first peg 535 can be configured to fit within
the first cuff ring wedge-mounting hole 125 and the second peg 545
can be configured to simultaneously fit within a second cuff ring
wedge-mounting hole 126, which is not visible in FIG. 5, but is
visible in FIG. 8. When these pegs 535 and 545 are secured within
their respective cuff ring wedge mounting holes 125 and 126 the
cuff ring wedge 555 can be secured within the locking section 102
of the cuff ring assembly 100. In an embodiment, the cuff ring
wedge 555 can be made from a harder, less flexible material than
that comprising the cuff ring 120.
[0050] FIG. 6 is a top view drawing of a cuff ring assembly 100,
wherein two trailing limbs 160 and 161 of the dual-lumen
hemodialysis catheter 101 have been threaded through the cuff ring
assembly 100, and the two trailing limbs 160 and 161 have been
split apart to a selected location (not visible in FIG. 6) and this
location is located within the locking section 102 of the cuff ring
assembly 100 and a cuff ring wedge (not visible in FIG. 6) has been
placed into the top end 111 of the locking section 102 and between
the trailing limbs 160 and 161 at the location, thus securing the
two trailing limbs 160 and 161 to the cuff ring assembly 100,
according to an embodiment.
[0051] In this view the first peg 535 can be seen within the first
cuff ring wedge-mounting hole 125, indicating that the cuff ring
wedge 555 has been securely connected to the locking section 102,
thereby also securely connecting the trailing limbs 160 and 161 of
the dual-lumen hemodialysis catheter 101 to the locking section 102
of the cuff ring assembly 100. The second peg 545 (not visible in
FIG. 6) can be inserted into the second cuff ring wedge-mounting
hole 126 (not visible in FIG. 6) located directly opposite the
first cuff ring wedge-mounting hole 125.
[0052] FIG. 7A is a rear view drawing of a cuff ring assembly 100
absent a cuff ring wedge 555, according to an embodiment.
[0053] In this view, the locking section 102 of the cuff ring
assembly 100 can be viewed clearly, including the locking section
opening 702 wherein a cuff ring wedge 555 can be inserted. As the
cuff ring assembly comprises a hollow tube, a first opening 712 can
be seen in this figure by looking through the locking section
opening 702. Additionally, side views of two suture wings 103 as
well as a side view of a cuff 130 can also be viewed.
[0054] FIG. 7B is a rear view drawing of a cuff ring assembly 100
wherein a cuff ring wedge 555 has been connected to the locking
section 102 of the cuff ring assembly 100, according to an
embodiment. The back side 590 of the cuff ring wedge 555, discussed
in detail above with reference to FIG. 5B, can be viewed in this
figure.
[0055] In an embodiment, when a cuff ring wedge 555 has been
connected to the locking section 102 within a locking section
opening 702, D-shaped spaces 715 can be created on either side of
the cuff ring wedge 555, which can be configured to each allow a
trailing limb of a dual-lumen hemodialysis catheter (not shown in
FIG. 7B) to pass through them. In an embodiment, the size and shape
of the cuff ring wedge 555 can be sufficient to press each trailing
limb (not shown in FIG. 7B) against the outside inner-wall 725 of
the locking section 102, thus securing the trailing limbs to the
locking section 102 and the cuff ring assembly 100, while still
allowing fluids to pass through the trailing limbs.
[0056] FIG. 8 is a perspective view drawing showing the rear, top
and side of a cuff ring assembly 100, according to an embodiment.
This view depicts the locations of two cuff ring wedge mounting
holes 125 and 126 within the locking section 102 and the locking
section opening 702 in an embodiment.
[0057] FIG. 9 is a top view drawing of a cuff ring assembly 100,
wherein two trailing limbs 160 and 161 of the dual-lumen
hemodialysis catheter 101 have been threaded through the cuff ring
assembly 100, and the two trailing limbs 160 and 161 have been
split apart to a selected location (not visible in FIG. 9) and this
location is located within the locking section 102 of the cuff ring
assembly 100 and a cuff ring wedge (not visible in FIG. 9) has been
placed into the top end 111 of the locking section 102 and between
the trailing limbs 160 and 161 at the location, thus securing the
two trailing limbs 160 and 161 to the cuff ring assembly 100, and
wherein the two trailing limbs 160 and 161 have been trimmed to the
proper length and hub assemblies 905 have been connected to each
trailing limb 160 and 161, according to an embodiment.
[0058] FIGS. 10A through 10D show four stages (in time sequence) of
the of the present tunneled dual-lumen hemodialysis catheter
placement.
[0059] FIG. 10A is a top view drawing of a patient's upper torso
1000, wherein the trailing limbs 160 and 161 of the dual-lumen
hemodialysis catheter 101 extend from an incision 1010 in the
patient's chest located at one end of a subcutaneous tunnel (not
visible), according to an embodiment.
[0060] In an embodiment, a surgeon can use a tunneler or similar
device to position the leading (distal) end of a dual-lumen
hemodialysis catheter 101 within a large vein in the patient's
upper torso 1000, usually the superior vena cava. The surgeon can
then use a tunneler or similar device to retrograde tunnel the
trailing limbs 160 and 161 back through a subcutaneous tract where
they can be placed through a skin exit site, typically an incision
created with a scalpel, which can be located on the surface of the
patient's upper torso 1000.
[0061] FIG. 10B is a top view drawing of a patient's upper torso
1000, wherein the trailing limbs 160 and 161 of the dual-lumen
hemodialysis catheter 101 extend from an incision 1010 in the
patient's chest and the trailing limbs 160 and 161 have been
threaded through the cuff ring assembly 100 so that the trailing
limbs 160 and 161 extend through a top end 111 of the cuff ring
assembly 100 and a cuff 130 has been used to close the incision
1010 over a bottom end 112 of the cuff ring assembly 100 and the
cuff 130 has been positioned within a subcutaneous tunnel (not
visible), according to an embodiment. (The parts of the cuff ring
assembly 100 and dual-lumen hemodialysis catheter 101 shown in
broken lines in FIG. 10B thru 10D are located below the patient's
skin and are not visible.)
[0062] In an embodiment, a surgeon or other user can then place the
cuff ring assembly over the trailing limbs 160 and 161 dual-lumen
hemodialysis catheter 101 by threading the trailing limbs 160 and
161, comprising the proximal end of the hemodialysis catheter, 101
into the first opening (not visible in FIG. 10B) located at the
bottom end 112 of the cuff ring assembly 100 and out from the
second opening (not visible in FIG. 10B) located at the top end 111
of the cuff ring assembly 100. In an embodiment, a surgeon or other
user can position the cuff 130 within the subcutaneous tunnel
through the incision 1010 in order to close and seal the incision
1010 to prevent infection.
[0063] FIG. 10C is a top view drawing of a patient's upper torso
1000, wherein the trailing limbs 160 and 161 of the dual-lumen
hemodialysis catheter 101 extend from an incision 1010 in the
patient's chest and the trailing limbs 160 and 161 have been
threaded through the cuff ring assembly 100 so that the trailing
limbs 160 and 161 extend through a top end 111 of the cuff ring
assembly 100 and a cuff 130 has been used to close the incision
1010 over a bottom end 112 of the cuff ring assembly 100 and the
cuff 130 has been positioned within a subcutaneous tunnel (not
visible) and the trailing limbs 160 and 161 have been split apart
down a selected point to the cuff ring assembly 100, according to
an embodiment. The trailing limbs 160 and 161 can be trimmed to the
desired length with scissors or any other suitable cutting
tool.
[0064] In an embodiment, after the cuff ring assembly 100 has been
positioned over the trailing limbs 160 and 161, a user can then
split apart the trailing limbs 160 and 161 to a selected point
within the top end 111 of the cuff ring assembly 100 and trim the
trailing limbs 160 and 161 to a desired length. In an embodiment,
the trailing limbs 160 and 161 can be configured so that they can
be pulled apart by hand. Also shown in FIG. 10C, the user can
secure the cuff ring assembly 100 to the patient's upper torso 1000
by connecting one or more suture wings 103 to the patient's skin
with sutures 1032.
[0065] In an embodiment, a user can secure the trailing limbs 160
and 161 to the top end 111 of the cuff ring assembly 100 by placing
a cuff ring wedge 555 within the top end 111 and between the
trailing limbs 160 and 161.
[0066] FIG. 10D is a top view drawing of a patient's upper torso
1000 wherein the trailing limbs 160 and 161 of the dual-lumen
hemodialysis catheter 101 extend from an incision 1010 in the
patient's chest and the trailing limbs 160 and 161 have been
threaded through the cuff ring assembly 100 so that the trailing
limbs 160 and 161 extend through a top end 111 of the cuff ring
assembly 100 and a cuff 130 (not numbered in FIG. 10D) has been
used to close the incision 1010 (not numbered in FIG. 10D) over a
bottom end 112 of the cuff ring assembly 100 and its trailing limbs
160 and 161 have been split apart down to a selected position
within the cuff ring assembly 100 and a cuff ring wedge 555 (not
visible in FIG. 10D) has been connected to the cuff ring assembly
100 to secure the trailing limbs 160 and 161 to the cuff ring
assembly 100, and hub assemblies 905 have been connected to each
trailing limb 160 and 161, according to an embodiment.
[0067] In an embodiment, the user can connect a hub assembly 905 to
each trailing limb 160 or 161. These hub assemblies 905 allow
additional tubing (not shown), which can be required to perform
hemodialysis, to be connected to the present dual-lumen
hemodialysis catheter 101. A standard hub assembly 905 can also
have the ability to prevent the flow of liquids either into or out
from the present dual-lumen hemodialysis catheter 101.
[0068] The cuff ring assembly 100 can be made in total or in part
from various plastics or similar suitable materials, known in the
art of medical devices.
[0069] The many features and advantages of the invention are
apparent from the detailed specification and, thus, it is intended
by the appended claims to cover all such features and advantages of
the invention that fall within the true spirit and scope of the
invention. Further, since numerous modifications and changes will
readily occur to those skilled in the art, it is not desired to
limit the invention to the exact construction and operation
illustrated and described, and accordingly all suitable
modifications and equivalents may be resorted to, falling within
the scope of the invention. If any portion of any component of the
invention is not shown in the figures taken in their entirety, then
absent any written description to the contrary it can be assumed
that such portion matches corresponding visible/described portions
of the component. The inventive concept includes all methods of
using all or any combination of the features described herein,
including the methods illustrated in sequence from FIGS. 10A to 10D
and their accompanying description.
* * * * *