Note: Descriptions are shown in the official language in which they were submitted.
CA 02678253 2009-09-08
CATHETER ANCHORING SYSTEM
Background of the Invention
Field of the Invention
The present invention relates in general to a percutaneous catheterization
system, and, in particular, to a
catheter anchoring system which securely interconnects an indwelling catheter
with a tubing and securely anchors such
interconnection to a patient's skin.
Description of Related Art
Medical treatment of patients commonly involves the use of percutaneously
inserted catheters to direct fluids
directly into the bloodstream, a specific organ or an internal location of the
patient, or to monitor vital functions of the
patient. For instance, intra=arteriosus catheters are commonly used to direct
fluids andlor medication directly into the
bloodstream of the patient. Epidural catheters are commonly used to direct
anesthesia into an epidural space to
anesthetize a specific location of the patient. Intervascular catheters are
commonly used to monitor arterial blood
pressure.
The fluid (e.g., parenteral liquid, medication or anesthesia) typically drains
from a container positioned above the
patient. The fluid flows through tubing and into an indwelling catheter. The
catheter and fluid tubing are commonly
removably attached by a conventional lure=type connector, such as the type
described in U.S. Patent No. 4,224,937.
In common practice, a health care provider, such as, for example, a nurse or
doctor (for ease of description, as
used herein the term "nurse" will refer to health care providers generally and
will not be restrictive in meaning), uses
adhesive or surgical tape to maintain the catheter in place on the skin of the
patient. The connection between the tubing
and the catheter is likewise maintained by use of tape.
The nurse may also form a safety loop in the tubing so that any tension
applied to the tubing does not directly
pass to the catheter cannuta, but rather is absorbed by the slack of the
safety loop. The nurse typically loosely tapes the
loop to the skin of the patient.
This entire taping procedure takes several minutes of the valuable time of the
health care provider. Furthermore,
nurses commonly remove their gloves when taping because most nurse find such
taping procedures difficult and
cumbersome when wearing gloves.
The catheterization process often requires frequent disconnection between the
catheter and the fluid supply
tube. For instance, intravenous catheterization is frequently maintained for
several days, depending upon the condition of
the patient. The catheter tubing is generally replaced every 24 to 48 hours in
order to maintain the sterility of the fluid and
the free-flow of the fluid through the tubing. A nurse must thus frequently
change the tubing and retape the connection.
Moreover, the tape, which secures the catheter to the skin of the patient,
often covers the cannula insertion point. The
nurse must remove the tape to inspect the insertion point for inflammation or
infection, and must then repeat the above=
described taping procedure.
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A great deal of valuable time is thus used in applying significant amounts of
surgical tape to indwelling
catheters. The frequent application and removal of surgical tape also commonly
results in the excoriation of the skin of
the patient in the area of the insertion.
A number of catheterization systems have recently been developed which improve
the stabilization of the
catheter system and obviate the need for frequent application and removal of
surgical tape. One such system is disclosed
by U.S. Patent No. 5,192,273 issued to the present Applicant, which is hereby
incorporated by reference.
The '273 patent discloses an adaptor which interconnects the catheter with a
fluid supply tubing. The adaptor
snaps into a base attached to the patient's skin by an adhesive pad.
Specifically, a nurse presses the adaptor between
upstanding legs of the base. Detents on the adaptor legs slide into
corresponding annular grooves in the adaptor body to
hold the adaptor to the base.
Although the base holds the adaptor securely in place, a nurse may have
difficulty positioning and aligning the
annular grooves of the adaptor with the detents on the base. Exigent
circumstances may further exacerbate the
difficulties associated with properly positioning the adaptor onto the base.
Some nurses and other health care providers
may also have trouble determining how to engage the catheter adaptor with the
base.
Summary of the Invention
The catheter anchoring system of the present invention provides an adaptor
retainer which is not position or
technique sensitive. That is, the nurse simply locates the catheter adaptor
generally above the retainer, and presses the
adaptor into the retainer. Engagement requires only coarse alignment of the
adaptor with the retainer.
In accordance with one aspect of the present invention, an anchoring system is
provided for use with a catheter
having an adaptor with at least one recess. The anchoring system has a
retainer to receive the adaptor. The retainer
includes a channel that extends through the retainer about a longitudinal
axis. The channel is configured to receive at least
a portion of the adaptor in a snap-fit manner. At least one projection on the
retainer extends into the channel in a direction
generally normal to the longitudinal axis. The projection has a longitudinal
length so dimensioned to substantially equal the
longitudinal length of the recess of the adaptor. The cooperation between the
projection of the retainer and the recess of
the adaptor inhibit longitudinal movement of the adaptor relative to the
retainer.
In accordance with another aspect of the present invention, an anchoring
system includes a retainer and an
anchor pad. The retainer includes a channel that extends through the retainer
about a longitudinal axis. The channei is
configured to receive at least a portion of the adaptor in a snap-fit manner.
At least one projection on the retainer extends
into the channel in a direction generally normal to the longitudinal axis. The
projection has a longitudinal length so
dimensioned to substantially equal the longitudinal length of the recess of
the adaptor. The cooperation between the
projection of the retainer and the recess of the adaptor inhibit longitudinal
movement of the adaptor relative to the retainer.
The anchor pad has an adhesive bottom surface attachable to the skin of a
patient and an upper surface attachable to the
retainer.
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In accordance with yet another aspect of the present invention, an anchoring
system is provided for use with a
catheter having an adaptor with a radially extending member that projects from
the fitting. The anchoring system
comprises a retainer that includes first and second channel portions. The
channel portions extend about a longitudinal axis,
and each is configured to receive a corresponding portion of the catheter
fitting. A plurality of lateral slots are positioned
between the channel portions. Each lateral slot is dimensioned so as to
receive the radially extending member of the
catheter fitting to prevent the catheter from moving in a longitudinal
direction. The lateral slots are also arranged next to
each other along the longitudinal axis so as to provide multipfe positions in
the longitudinal direction in which to insert the
radially extending member of the catheter fitting when positioning the
catheter fiiting within the retainer.
Another aspect of the present invention involves a catheterization system
includes a catheter and a retainer to
secure the catheter to a patient. The catheter includes a fitting with a
radially extending member that projects from the
fitting. The retainer includes first and second channel portions that extend
about a longitudinal axis. Each channel portion
generally has a truncated cross-sectional shape with an opening along the
longitudinaf axis. Each channel is also sized to
surround at least a portion of the fitting through an arc of greater than 180
about the longitudinal axis. At least one
lateral slot of the retainer extends generally perpendicular to the
longitudinal axis and lies between the first and second
channel portions. The slot has a longitudinal length so dimensioned to
substantially equal the thickness of the radially
extending member of catheter fitting and to be generally less than the
combined longitudinal lengths of the first and second
channel portions. This dimensional relationship between the channel portions
and the slot provides lateral stability of the
catheter fitting when the radially extending member is positioned within the
lateral slot of the retainer.
In accordance with a further aspect of the present invention, a catheter
anchoring system comprises a catheter
adaptor, a retainer and a base pad which adheres to the skin of a patient and
supports the retainer. The catheter adaptor
comprises a tubular body connected to a radially extending support arm. The
support arm in tum connects to a clip which
pivots relative to the tubular body.
The retainer comprises a pair of opposing longitudinal walls. Each wall
defines a series of slots. Each slot is
sized such that a portion of the support arm of the catheter adaptor extends
through the slot. The slot prevents the
support arm from moving in a direction generally parallel to a longitudinal
direction of the retainer.
The retainer further comprises a central channel which extends through the
retainer about an axis which is
generally parallel to the longitudinal axis. The channel is interposed between
the opposing longitudinal walls and has a
truncated circular cross-sectional shape. The central channel, in cross-
section, is sized to encompass the tubular body
through an angle greater than about 180 .
The anchoring system may additionally comprise a tube clip configured to
receive a portion of the tube. The
anchoring system may also comprise an S-clip having a plurality of retainers
to secure a microbore tubing connected to the
tube by the adaptor.
An additional aspect of the present invention provides a catheter anchoring
system for securing an indwelling
catheter within a body lumen of a patient and for securely interconnecting the
indwelling catheter with a tube. The
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catheter anchoring system comprises a catheter adapter having a generally
tubular body defined between distal and
proximal ends. The distal end is confirgured to engage the catheter proximal
end and the proximal end is configured to
couple to a distal end of the supply tube. The catheter adapter additionally
comprises a radially extending member which
projects from an exterior surface of the tubular body in a radial direction.
A retainer of the catheter anchoring system comprises a longitudinal channel
configured to receive the tubular
body of the adapter in snap fit manner. The retainer additionally comprises a
plurality of lateral slots or projections
which are sized to receive and to capture the radially extending member of the
adapter with the adapter positioned within
the channel. The slots can be formed in a variety of ways, such as by
laterally arranging a plurality of gaps next to each
other and through the opposing longitudinal walls of the retainer. The
projections can similarly be formed in a variety of
ways, such as by laterally arranging a plurality of projections next to each
other from the opposing longitudinal walls of the
retainer and projecting the projections into the channel. The retainer
prevents the adapter from sliding in a longitudinal
direction when one of the slots.
In a preferred embodiment, the radially extending member comprises a support
arm which connects a clip to the
tubular body. In an alternative preferred embodiment, the radially extending
member comprises an annular collar which
circumscribes the tubular body.
In accordance with a preferred method of anchoring an indwelling catheter/tube
interconnection to a patient, an
adapter is provided having a generally tubular body with a recess. An anchor
pad is also provided with an adhesive back.
The anchor pad supports a retainer configured to receive the adapter and has a
series of lateral projections. The anchor
pad is attached to the patient's skin proximate to an indwelling catheter. The
recess of the adapter is positioned above the
series of projections. The retainer is deflected so as to open the channel to
a size sufficient to receive the adapter, and the
adapter is inserted into the channel. The recess is inserted around at least a
portion of one of the projections. The retainer
is then permitted to spring back to an undeflected position such that the
tubular body is captured within the retainer.
In accordance with an aspect of the present invention, there is provided an
anchoring device for use with a
medical article having an extending member projecting therefrom, the device
comprising:
a retainer having a channel section extending along a longitudinal axis of the
retainer and configured to receive
at least a portion of the medical article, a longitudinal slot along said
retainer through which the medical article can pass,
the slot having a lateral width less than a diameter of the channel section,
and at least one projection extending towards
the longitudinal axis of the retainer and being configured to engage the
extending member of the medical article in a
manner inhibiting longitudinal motion of the medical article through the
retainer; and
a flexible anchor pad having an adhesive bottom surface and a top surface,
said retainer being supported by
said anchor pad.
According to a further aspect of the present invention, there is provided a
catheterization system comprising:
a medical article having a body with at least one member projecting therefrom;
and a retainer including a channel that
extends about a longitudinal axis, the channel generally having a truncated
cross-sectional shape with an opening that lies
generally parallel to the longitudinal axis, the channel extending about the
longitudinal axis at least to an extent where the
channel surrounds at least half of the body of the medical article when the
medical article is disposed within the channel,
and at least one projection that extends inwardly toward the longitudinal axis
and lies generally within the channel, said
projection being configured to contact the at least one member of the medical
article when the medical article is inserted
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CA 02678253 2009-09-08
into the retainer with the at least one member disposed within the channel and
being dimensioned to inhibit longitudinal
movement of the medical article within the retainer.
According to a further aspect of the present invention, there is provided a
securement system for an elongated
medical article comprising a body defined about a longitudinal axis, and a
retainer including a first side and a second side
that together define a space of sufficient size to receive a portion of the
medical article, the retainer receiving at least a
portion of the medical article within the space, and a projection extending in
a direction generally normal to the longitudinal
axis of the retainer, the projection being configured so as to cooperate with
the medical article in a manner substantially
inhibiting axial motion of the medical article through the retainer.
Brief Description of the Drawings
These and other features of the invention will now be described with reference
to the drawings of preferred
embodiments which are intended to illustrate and not to limit the invention,
and in which:
Figure 1 is a perspective view of a catheter anchoring system in accordance
with a preferred embodiment of the
present invention, mounted on the back of a patient's hand;
Figure 2 is a top plan view of the catheter anchoring system of Figure 1;
Figure 3 is a top plan view of a retainer of the catheter anchoring system of
Figure 2;
Figure 4a is a front elevational view of the retainer of Figure 3;
Figure 4b is a rear elevational view of the retainer of Figure 3;
Figure 5 is a side elevational view of the retainer of Figure 3;
Figure 6 is a top plan view of a catheter anchoring system in accordance with
another preferred embodiment of
the present invention;
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Figure 7a is a front elevational view of a retainer and rail assembly of the
catheter anchoring system of Figure 6;
Figure 7b is a side elevational view of the retainer and rail assembly oS
Figure 6;
Figure 8 is a cross-sectional view of the retainer and rail assembly taken
along line 8=8 of Figure 7a;
Figure 9 is a top plan view of a catheter anchoring system in accordance with
an additional preferred
embodiment of the present invention;
Figure 10 is a side elevational view of an S-clip of the catheter anchoring
system of Figure 9 taken along line 10-
10;
Figure 11 is a top perspective view of a catheter anchoring system in
accordance with an additional preferred
embodiment of the present invention;
Figure 12 is a top plan view of the catheter anchoring system of Figure 11
illustrating an adaptor held by a
retainer;
Figure 13a is a side elevational view of the retainer of Figure 12;
Figure 1 3b is a top plan view of the retainer of Figure 12;
Figure 14 is a partially sectioned perspective view of an alternative
embodiment of a catheter adaptor which
may be used with the anchoring system of Figure 11;
Figure 15a is side elevational view of a catheterization system in accordance
with another preferred embodiment
of the present invention with a retainer of the catheterization system shown
in cross-section;
Figure 15b is a top plan view of the retainer of Figure 15a as viewed in the
direction of arrows 15b-15b;
Figure 15c is a front end elevational view of the retainer of Figure 15a as
viewed in the direction of arrows 15c-
15c; and
Figure 16 is a perspective view of a catheterization system configured in
accordance with another embodiment
of the present invention, and illustrates a catheter in a position separate
from a retainer of the catheterization system;
Figure 17 is a perspective view of a catheterization system configured in
accordance with another embodiment
of the present invention, and illustrates the a catheter adaptor having a
plurality of radial recesses and a retainer having a
plurality of projections that cooperate with the recesses when the retainer
receives the catheter adaptor; and
Figure 18 is a perspective view of the catheterization system configured in
accordance with an additional
embodiment of the present invention, and illustrates the catheter adaptor
having a plurality of radial recesses and a
retainer having a plurality of projections that extend into a channel having a
tapered diameter.
Detail Descriation of Preferred Embodiments
Figure 1 illustrates in perspective view a catheter anchoring system 10 in
accordance with the present invention.
The anchoring system 10 securely connects a tube 12(e.g., a fluid supply tube)
to an indwelling catheter 14 and
maintains the catheter 14 in the desired indwelling position. The anchoring
system 10 is designed for rapid attachment to
the catheter 14 and to the patient, without requiring precise alignment or
positioning of the components of the anchoring
system 10.
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Moreover, sturdy anchoring of the catheterization system is achieved without
the use of surgical tape. For most
catheterization, the anchoring system is attached to the patient only once.
Although the fluid supply tubing 12 may be
replaced every 24 to 48 hours for intravenous catheterization, the components
of the anchoring system 10 attached to the
patient remains in place. Thus, surgical tape need not be applied and removed
from the patient's skin on multiple
occasions.
The catheter anchoring system 10 principally comprises a flexible pad 16
having an adhesive bottom side 18
which attaches to the skin of a patient when used. The pad 16 supports a
retainer 20. The retainer 20 is configured to
receive and secure in place a catheter adaptor 22 which interconnects the hub
30 of an indwelling catheter 14 and the
fluid supply tube 12 connected to a fluid supply container (not shown). The
container maintains the fluid to be dispensed
to the patient which is fed either by gravity or by pressure. A clamp (not
shown) may be used to regulate the fluid flow
through the tubing 12. The pad 16 may also support a tubing clip 24 which is
used to retain a portion of tubing 12.
Although Figure 1 illustrates the catheter anchoring system located on the
back of a patient's hand (illustrated in
phantom lines), it is contemplated that the present invention may be used for
catheterization in other locations on the
patient's body. For instance, the anchoring system may be used on the medial
side of the wrist in connection with a radial
artery. The anchoring system 10 may also be used for epidural catheterization,
as discussed in detail below, and thus
located on the anterior or posterior of the patient's torso.
Figure 1 illustrates a longitudinal axis, a transverse axis and a lateral axis
in relation to the catheter anchoring
system 10 to facilitate the following description. Additionally, as used
herein, "the longitudinal direction" refers to a
direction substantially parallel to the longitudinal axis. "The lateral
direction" and "the transverse direction" are in
reference to the lateral axis and transverse axis, respectively. Also,
"proximal" and "distal" are in reference to the
proximity of the fluid supply container attached to the tube 12 (see Figure
1). The individual components of the catheter
anchoring system 10 will now be described in detail.
Catheter Adaptor
. Figure 1 illustrates the catheter adaptor 22 interconnected with a catheter
14. Figure 2 illustrates the catheter
adaptor 22 disconnected from catheter 14. Although these figures illustrate
the adaptor 22 as the type disclosed in U.S.
Patent No. 5,193,273, it is contemplated that other types of adaptors can be
used as well with the present catheter
anchoring system 10. For instance, the catheter adaptor 22 could be a lure-
type adaptor, such as the type illustrated by
Figure 11 and described below, or a lure=lock type catheter adaptor 22, such
as the type illustrated by Figure 14 and
described below. It is contemplated that those skilled in the art could
readily select the type of catheter adaptor 22 to be
used with the present catheter anchoring system 10 depending on the particular
application (e.g., venous, arterial, epidural,
peripheral, etc.) of the anchoring system 10.
As best seen in Figure 2, the adaptor 22 comprises a tubular body 25 defined
between a distal end 26 and a
proximal end 28. The proximal end 28 is adapted to receive a distal end of the
tube 12. In an exemplary embodiment, at
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least a portion the fluid supply tube is permanently attached to the body
proximal end 28. As shown in Figure 2, the
proximal end of the tubing may then include a standard lure-type connector 29
to connect into a fluid supply line 12.
The distal end 26 is configured to engage the proximal hub 30 of the catheter
14 (see Figure 1) or any lure-type
connector. Although Figure 2 illustrates the distal end of the adaptor 22 as
having a frusto-conical shape configured to
engage a standard lure-type catheter hub 30, it is contemplated that the
distal end 26 could be configured as well to
engage other types of catheter connectors, such as, for example, a Toughy-
Bourst adaptor.
A support arm 32 extends outwardly from the tubular body 25 in cantilever
fashion. The support arm 32
supports, on a radially outer end of the arm 32, a clip support element (not
shown) that extends generally parallel to and is
spaced from a longitudinal axis of the tubular body 25.
figure 2 further illustrates a clip 34 of the catheter adaptor. The clip 34
attaches to and slides over the clip
support element in the longitudinal direction. The clip 34 includes a distal
latch 36 which has a generally forked shape to
engage a outer surface of the catheter hub 30 distal of a hub collar 38 (see
Figure 1) to securely attach the adaptor 22 to
the catheter hub 30.
Interengaging structure (not shown) between the clip support element and the
clip 34 permits the clip 34 to slide
in the proximal direction, but prevents the clip 34 from sliding in the distal
direction. The interengaging element desirably
comprises a series of ratchet teeth (not shown) disposed up on upper surface
of the clip support element and a pawl (not
shown) connected to the clip 34. The pawl extends from the clip 34 in a
cantilever fashion and engages the ratchet teeth
to prevent distal movement of the clip, as discussed in detail in U.S. Patent
No. 5,193,273, which has been incorporated
by reference.
The tubular body 25, the support arm 32 and the clip support element are
preferably integrally formed of molded
plastic, such as, for example, a clear polycarbonate, so as to be generally
stiff, but somewhat flexible. The support arm 32
desirably has enough elasticity to bend. Depressing the proximal end of the
clip 34 towards the tubular body 25 moves the
latch 36 of the clip 34 away from the tubular body 25. In this manner, the
clip 34 pivots about the tubular body 25.
With reference again to Figure 2, the clip support element desirably comprises
a protuberance 40 positioned on
an inner surface 42 of the clip support element, proximate to the proximal end
of the clip 34. The protuberance is spaced
from the support arm by a distance L. The protuberance 40 prevents the clip 34
from pivoting when secured by the
retainer 20, as discussed below in detail. The protuberance 40 also limits the
degree of deflection of the support arm 32
to reduce fatigue, as fully explained in U.S. Patent No. 5,193,273, which has
been incorporated by reference.
Retainer for Catheter Adaptor
Figures 3 through 5 illustrate the retainer 20. The retainer 20 has a
generally parallelepiped shape defining a
central channel 44 interposed between a pair of opposing longitudinai walls
46. The central channel 44 extends through
the retainer 20 along an axis which is generally parallel to the longitudinal
axis of the retainer.
As best seen in Figure 4, the central channel 44 has a generally circular
cross-sectional shape which is truncated
at a upper end to form a generally U-shaped channel having an upper opening
47. The central channel 44 has a diameter
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CA 02678253 2009-09-08
sized to receive the tubular body 25 of the catheter adaptor 22. In a
preferred embodiment, the diameter of the central
channel 44 generally matches that of the tubular body 25 or is slightly
larger.
In cross=section, the central channel 44 extends through an arc greater than
180 about the channel axis such
that the transverse length of the opening 47 is less than the diameter of the
central channel 44. In an exemplary
embodiment, the central channel 44 extends through an arc of about 200 about
the channel axis.
Figure 5 illustrates the channel axis which is desirably skewed relative to a
base surface 48 of the retainer 20.
An incident angle 0 formed between the base surface 48 and the channel axis is
less than 45 . The incident angle 0
desirably ranges between 0 and 30 . In an exemplary embodiment for intravenous
use, the angle 0 preferably equals
approximately 7. In another exemplary embodiment for arterial use, the
incident angle 0 preferably equals about 22 . In a
further exemplary embodiment, for peripherally inserted central catheters
(PICC), the incident angle 0 preferably equals 0.
The longitudinal walls 46 are substantially identical. Each wall 46 has a
thickness measured in the lateral
direction less than the length of the support arm 32. The wall 46 is thus
interposed between the tubular body 25 and the
clip 34 when the tubular body 25 is inserted into the central channel 44. The
length of each wall 46, measured in the
longitudinal direction, is preferably coextensive with the length of the
retainer 20.
Each wall 46 comprises a uniform series of slots 50. The series comprises at
least two (2) slots 50, and not
more than twenty (20) slots 50. More preferably, the series comprises less
than seven (7) slots 50. In an exemplary
embodiment, as illustrated in the figures of the application, the series
comprises four (4) slots 50.
Each slot 50 is sized to receive the support arm 32 of the catheter adaptor 22
to prevent longitudinal
displacement of the adaptor 22, as discussed in detail below. Each slot 50
desirably has a rectangular shape. As seen in
Figure 3, the slots 50 extend from an exterior surface 52 through the wall 44,
and open into the central channel 44. The
width of each slot 50 (measured longitudinally) is desirably slightly greater
than the width of the support arm 32,
measured in the longitudinal direction to receive the support arm 32, as
discussed below.
As illustrated by Figure 5, each slot 50 has a height as measured in the
transverse direction between an upper
edge 54 of the longitudinal wall 46 and the bottom 56 of the central channel
44. The height of the slot 50 desirably
equals approximately the width of the support arm 32 such that the support arm
32 does not protrude from the retainer
20 in the transverse direction.
The spacing S between the slots 50, on center, desirably equals about half the
distance L(see Figure 2) between
the support arm 32 and the protuberance 40 of the catheter adaptor 22.
As Figure 3 illustrates, a distance X between the most distal slot 50 and the
distal end of the retainer 20 is less
than the longitudinal distance Y(see Figure 2) between the support arm 32 and
the latch 36 positioned in its most proximal
position. This spacing enables the support arm 32 to rest in the most distal
slot 50 with the latch 36 retaining a catheter
hub 30 distal of the retainer distal end.
Figure 5 illustrates the upper edge 50 of the longitudinal wall 46 which
comprises a series of chamfers 58, each
of which slopes into a slot 50. That is, the portion of upper edge 50 of the
longitudinal wall 46 which surrounds a slot 50
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CA 02678253 2009-09-08
includes a pair of chamfers 58, with one chamfer 58 located on either side of
the siot 50. The chamfers 58 slope
downward toward the slot 50 to facilitate the insertion of the support arm 32
of the catheter adaptor 22 into the slot 50,
as discussed below.
As shown by Figures 3 and 5, each longitudinal wall 46 further comprises a
relief 60 disposed on the proximal
end of the retainer 20. The relief 60 is sized to receive the protuberance 40
of the adaptor 22. The depth of the relief 60
measured in the lateral direction desirably is slightly greater than the
height of the protuberance 40 (i.e.,, the distance by
which the protuberance protrudes from the inner surface 42).
The relief 60 is spaced in the longitudinal direction from the most proximal
slot 50 by a distance approximately
equal to the spacing S between the slots 50. Thus, the protuberance 40 rests
in the relief 60 with the support arm 32
positioned in either of the two most proximal slots 50, as discussed in detail
below.
Figures 3 and 4 illustrate a key-way groove 62 of the retainer 20. The key-way
groove 62 facilitates the
removal of the catheter adaptor 22 from the retainer 20, as discussed below in
detail. The key-way groove 62 lies at the
proximal end of the retainer 20. The key-way groove 62 extends into the
retainer 20, and toward the retainer base
surface 48 from the bottom surface 56 of the central channel 44. The key-way
groove 62 has a transverse width less
than the diameter of the central channel 44, and more preferably has a width
approximately equal to two-thirds the
diameter of the central channel 44. The longitudinal length of the key-way
groove 62 desirably equals approximately the
longitudinal length of the recesses 60 in the longitudinal walls 46.
The retainer 20 is made of relatively stiff plastic material (e.g.,
polycarbonate), but is somewhat flexible such
that the adaptor 22 forces the upper edges 54 of the longitudinal walls 46
outwardly when a nurse presses the adaptor 24
into the central channel 44 of the retainer 20. When the adaptor 22 sits in
the central channel 44, the upper edges 54 of
the walls 46 snap inwardly to their original position to securely hold the
adaptor 22 within the retainer 20.
An adhesive attaches the retainer 20 to base pad 16. Alternatively, the
retainer 20 may be attached to the base
pad 16 by like means (e.g., embedding or otherwise weaving the retainer 20
into the base pad 16) as well.
Base Pad
As illustrated by Figure 1, the flexible base pad 16 comprises a laminate
structure comprising an upper paper or
other woven or non-woven cloth layer 64, an inner cellulose foam layer 66, and
the bottom adhesive layer 18. Alternative,
the flexible base pad 16 may comprise an adhesive bottom layer and an upper
cellulose foam layer. An upper surface of the
foam layer is roughened by corona treating the foam with a low electric
charge, as known in the art. The roughened or
porous upper surface of the base pad 16 improves cyano-acrylate (or other
types of adhesive) adhesion when attaching the
retainer 20 to the pad 16.
A removable paper or plastic backing (not shown) desirably covers the bottom
adhesive layer 18 before use. The
backing preferably resists tearing and is divided into a plurality of pieces
to ease attachment of the pad 16 to the patient's
skin, as explained below. Desirably, the backing is split along the center
line of the flexible base pad 16 in order to expose
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only half of the adhesive bottom surface 18 at one time. The backing also
advantageously extends beyond at least one
edge of the base pad 16 to ease removal of the backing from the adhesive layer
18.
As seen in Figure 2, one or more tabs 67 may be attached to a portion of the
backing which extends beyond the
flexible base pad 16. In an exemplary embodiment, the tabs 67 have the same
laminate structure as the flexible base pad
16. The tabs 67 also can be formed by the paper backing extending beyond the
edge of the base pad 16. The tab 67 may
also include indicia 69 in the form of dots, words, figures or the like to
indicate the placement of fingers when removing
the backing from the base pad 16.
A nurse grips the tab 67, preferably at the location of the indicia 69, and
peels the backing off one half of the
bottom adhesive layer 18. The nurse then places the bottom layer 18 against
the patient's skin to adhere the base pad 16
to the patient. Light pressure over the upper layer 64 assures good adhesion
between the base pad 16 and the patient's
skin. The base pad 16, due to its flexibility, conforms to the contours of the
topical surface to which the base pad 16
adheras. The nurse then repeats this procedure for the other half of the pad
16. Alternatively, the nurse may completely
remove the backing from the pad 16 before attaching the pad 16 to the
patient's skin.
The base pad 16 desirably comprises a notch 68 positioned distal of the
location of the retainer 20 on the pad
16 and adjacent to the point of insertion of the catheter cannula. The notch
68 is sized to permit visual inspection of the
catheterized site.
As seen in Figure 2, the base pad 16 desirably may comprise indicia 70 in the
form of an arrow which indicates
the proper orientation of the base pad 16 in reference to catheterized site.
Although the figures illustrate the indicia in the
form of an arrow, it is contemplated that other forms of indicia, such as, for
example, words or other graphics, could be
used as well. In proper use, as illustrated in Figure 1, the indicia 70 should
point in the proximal direction, towards the
indwelling catheter 14, or otherwise indicate the proper locate of the pad 16
in reference to the indwelling catheter 14.
In an exemplary embodiment, the laminate structure of the base pad is
preferably formed by rolling a paper tape,
such as a micro-porous rayon tape, available commercially as MICRO-PORE tape
from 3M (Item No. 1530), over a medical
grade polyvinyl chloride foam tape, such as that available commercially from
3M (Item No. 9777L). The foam tape
preferably includes the bottom liner or backing. The base pad 16 and the tabs
67 are then stamped out of the laminated
sheet of foam and paper. The backing between the tabs and the base pad,
however, is desirably not severed such that the
tabs 67 remain attached to the backing covering the adhesive section 18 of the
base pad 16. The backing is then cut into
two pieces along the center line of the pad 16 and between the tabs 67.
Tube Clip
Figures 1 and 2 illustrate the tube clip 24. The clip 24 secures the fluid
supply tube 12 to form a safety loop, as
known in the art.
The tube clip has a plate-like base 72 adhered to or embedded in the base pad
16. The tube clip 24 may be
located on the base pad 16 on either side of the retainer 20 to accommodate
left hand or right hand mounting. As
CA 02678253 2009-09-08
illustrated in Figure 6, the anchoring system 10 may further include a second
tube clip 24 located on the other side of the
retainer 20 from the first tube clip 24.
The clip 24 defines a channel 74 having a generally circular cross-sectional
configuration truncated to form an
upper orifice 76. The diameter of the channel 74 is desirably slightly less
than that of the fluid supply tube 12 so as to
ensure a secure interconnection. The channel 74 receives a portion of the
fluid supply tube 12 through the orifice 76 upon
application of gentle pressure or by pulling the tubing 12 across and through
the orifice 76 of the tube clip 24, as explained
below. The clip 24 surrounds a substantial portion of the tubing 12 with the
tubing 12 positioned within the channel 74.
As seen in Figure 2, the upper edge of the channel includes tapered ends 77 at
the proximal and distal ends of
the clip 24. Each tapered end 77 forms a smooth transition between the side
edge of the channel 74 and the upper edge,
and tapers in lateral width from the side edge toward the center of the tube
clip 24. The tapered ends 77 help guide the
fluid supply tube 12 into the channel 74 when a nurse pulls the tube across
the clip 24. Thus, the nurse does not have to
pinch the tube 12 to insert it into the clip 24. Also, the nurse's gloves do
not get stuck in the clip 24 when inserting the
tube 12, as is typically the case where the nurse is required to pinch the
tube 12 to insert it into the clip 24.
Slide Clamp
As illustrated in Figures 1 and 2, the catheter anchoring system 10 desirably
additionally includes a slide clamp
78 to regulating fluid flow through the tubing, as known in the art. The clamp
78, at one end, includes an aperture 80
which receives the fluid supply tube 12, and, at the opposite end, includes a
tab 82. The clamp 78 has a generally forked
shape formed by a pair of prongs 84 which defines the aperture 80. The tube 12
snaps between the prongs 84 and into
the aperture 80, which has a diameter slightly larger that the fluid supply
tube 12.
The prongs 84 converge together in the direction towards the tab 82 to form a
tapering slot 86 which opens into
the aperture 80. The prongs 84 pinch the tube 12 closed with the tube 12
positioned in the slot 86 so as to block fluid
flow therethrough. The clamp 78, however, slides over the tube 12 with the
tube 12 positioned through the aperture 80.
The tab 82 desirably has a rectangular shape which generally corresponds the
to shape of the key-way groove
62 of the retainer 20. The tab 82 preferably has a thickness greater than that
of the distal end of key-way groove 62,
measured in the transverse direction, so as to pry the adaptor 22 from the
retainer 20. As explained in detail below, the
tab 82 may be used to remove the catheter adaptor 22 from the retainer 20.
Retainer Location Adiustment Mechanism
Figure 6 through 8 illustrate a catheter anchoring system 10a in accordance
with another preferred embodiment
of the present invention. Where appropriate, like numbers with an "a" suffix
have been used to indicate like parts of the
two embodiments for ease of understanding.
The catheter anchoring system l0a is substantially identical to the above-
described anchoring system 10, with
the addition of a retainer location adjustment mechanism 90.
As best seen in Figure 8, the location adjustment mechanism 90 comprises a
base 92 and interlocking
mechanism 94 which interconnects the base 92 and the retainer 20a. The
retainer 20a slides over the base 92 and the
11
CA 02678253 2009-09-08
interlocking mechanism 94 secures the retainer 20a to the base 92 at various
longitudinal positions. The adjustment
mechanism thus allows for precise positioning of the retainer 20 relative to
the catheter 14 after the pad 16 is attached to
the patient's skin.
The base 92 has a generally parallelepiped shape and comprises a rail 96.
Figure 7a best illustrates that the rail
96 desirably has a"dove-tail" configuration in cross section. That is, the
rail 96 has a cross-sectional shape with a flat
upper edge 98 and a pair of opposing side edges 100, each edge 100 being
angled inward from the upper edge 98 toward
the middle of the rail 96. The rail 96 extends along the longitudinal length
of the base 92 from the distal end 102 of the
base 92 to a point just short of the base proximal end 104. The base 92
includes a pair of stops 106 at the proximal end
104 which close off the proximal end of the rail 96.
An adhesive attaches the base 92 to base pad 16a. Alternatively, the base 92
may be attached to the base pad
16a by like means (e.g., embedding or otherwise weaving the base 92 into the
base pad 16a) as well.
The retainer 20a, configured in accordance with the above-description,
additionally comprises a groove 108
having a cross-sectional shape corresponding to that of the rail 96. The
retainer groove 108 receives the base rail 96 in a
manner permitting the retainer 20a to slide over the base 92, but preventing
the retainer 20a from moving in the
transverse direction away from the base 92. The base stops 106 also limit the
retainer's longitudinal travel in a proximal
direction.
The interfocking mechanism 94 comprises a plurality of teeth 110 disposed on
an upper surface 112 of the base
92, and a pawl 114 connected to the retainer 20a. The teeth 110 desirably have
generally rectangular cross-sectional
shapes, and lie in seriatim along the longitudinal axis of the base 92. The
upper edge of each tooth 110 includes a chamfer
112 to facilitate the engagement of the pawl 114 with a hollow 116 formed
between adjacent teeth 110, as discussed
below. The longitudinal length of each tooth 110 desirably extends generally
normal to the longitudinal axis of the base
92.
The pawl 114 has a shape configured to insert into and engage with the hollow
116 defined between the teeth
110. The pawl 114 preferably has a width, measured in the longitudinal
direction, slightly less than that of the hollow
116.
The retainer 20a comprises an aperture 118 extending between the retainer base
surface 48a and the channel
bottom surface 56a. A flexible finger 120 extends from the retainer 20a in a
cantilever fashion and into the retainer
aperture 118. The flexible finger 120 supports the pawl 114 at its distal end.
Although Figure 8 illustrates the finger 120
as extending in the distal direction, it is contemplated that the finger 120
can alternatively extend in the proximal direction
as well.
The flexible finger 120 preferably comprises a protuberance 122 which extends
upwardly beyond the channel
bottom surf ace 56a and into the central channel 44a with the finger 120 in an
undeflected state. The cantilever nature of
the finger 120 enables the finger 120 to deflect downward so that the
protuberance 122 lies below the retainer bottom
surface 56a. With the finger 120 so deflected, the pawl 114 engages the series
of teeth 110. That is, the pawl 114
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CA 02678253 2009-09-08
inserts into a hollow 116 defined between the teeth 110. The interengagement
between pawl 114 and the teeth 110
prevents the retainer 20a from sliding over the base 92.
S Clio
Figures 9 and 10 illustrate a catheter anchoring system 10b in accordance with
a further embodiment of the
present invention. Where appropriate, like numbers with an "b" suffix have
been used to indicate like parts of the
embodiments for ease of understanding.
The catheter anchoring system 10b is substantially identical to the anchoring
system 10 first described above,
with the addition of an S-clip 124 to retain a microbore or small bore tubing
126. The microbore tubing is commonly used,
for example, with epidural catheterization procedures, as discussed in detail
below.
The S-clip 124 comprises a generally U-shaped channel 128 defined by a pair of
arcuate, upstanding walls 130
extending from a base plate 132. As best seen in Figure 10, the S-clip 124
further comprises a plurality of retainers 134,
each retainer 134 having a spherical head 136 support by a cylindrical stem
138. The stems 138 extend from the base
plate 132. The retainer stems 138 are positioned from one another and from the
upstanding walls 130 by a distance
slightly greater than the diameter of the microbore tubing 126. The retainers
134 are also positioned such that the
spherical heads 136 of the retainers 134 are positioned from one another and
from the upstanding walls 130 by a distance
slightly less than the microbore tubing 126. As best seen in Figure 10, the
retainer heads 136 prevent the microbore
tubing 126 from disengaging from the S-clip 124 in the transverse direction
once the microbore tubing 126 is snaked
between the retainers 134 and the upstanding walls 130.
An adhesive attaches the base plate 132 of the S-clip 124 to base pad 16b.
Alternatively, the base plate 132
may be attached to the base pad 16b by like means (e.g., embedding or
otherwise weaving the base plate 132 into the
base pad 16b) as well.
The components of the anchoring system 10, save the base pad 16 (i.e., the
retainer 20, tube clip 24, adaptor
22, slide clamp 78, base 92 and S-clip 124), may be constructed in any of a
variety of ways which will be well known to
one of skill in the art. For instance, each individual component may be
integrally molded such as by injection molding or by
thermoplasty. The components preferably comprise a durably, flexible material,
and more preferably comprise a generally
inert, non-toxic material. In a preferred embodiment, the components are
molded of plastic, such as, for example,
polycarbonate, polyvinylchloride, polypropylene, polyurethane,
tetrafluoroethylene (e.g., TEFLON ), polytetrafluoroethylene
(a.k.a., PTEF), acetal resin (e.g., DELRIN ), chlorotrifluoroethylene (e.g.,
KEL-F ), nylon or like polymers.
Method of Use
The following discussion of the method of use will be with reference to
Figures 1 and 2, and initially will be in
the context of intravenous catheterization. As the following discussion will
illustrate, however, it is understood that the
anchoring system 10 can be used in other catheterization procedures as well.
The discussion of the method of use is
intended to augment the above description of the invention, and, thus, should
be read together.
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CA 02678253 2009-09-08
A nurse typically begins the catheterization process by positioning the
catheter 14 at a desired location above a
vein. The nurse introduces a needle or other stylus through a cannula portion
of the catheter 14 and into the skin of the
patient at a desired angle of incident. For intravenous use, the catheter 14
commonly has an incident angle of
approximately 7 . The nurse then inserts the cannula of the catheter 14 into
the patient and withdraws the needle or
stylus. The catheter hub 30 remains exposed above the skin.
The nurse inserts the distal end of the adaptor 26 into the catheter hub 30.
The clip 34 has been slidably
mounted in a most distal position so that it does not interfere with the
insertion of the adaptor distal end 26 into the
catheter hub 30.
The nurse then slides the clip 34 in a proximal direction to engage the
catheter hub 30. In this manually selected
position, the clip 34 securely attaches the adaptor 22 to the catheter 14. The
rachet teeth of the adaptor 22 cooperate
with the pawl to resist distal movement of the clip 34 and to hold the clip 34
in the manually selected position.
The nurse removes the paper backing which initially covers the adhesive bottom
surface 18 of the base pad 16,
and attaches the pad 16 to the patient's skin proximate to the indwelling
catheter 14. Specifically, the nurse grips the
backing tab 67 proximate to the retainer 20. The indicia 69 on the tab 67
indicates the locate at which the nurse should
grip the tab 67. The nurse then pulls on the tab 67 and peels the backing off
one half of the bottom adhesive layer 18.
The nurse positions the slot 68 of the pad 16 around the catheter cannula 14
with the instructing indicia 70 (e.g.,
indicating arrow) pointing in the direction of the catheter 14. The nurse then
places the bottom layer 18 against the
patient's skin to adhere the base pad 16 to the patient. light pressure over
the uppar layer 64 assures good adhesion
between the base pad 16 and the patient's skin. The base pad 16, due to its
flexibility, conforms to the contours of the
topical surface to which the base pad 16 adheres.
The nurse then repeats this procedure for the other half of the pad 16.
Alternatively, the nurse may completely
remove the backing from the pad 16 before attaching the pad 16 to the
patient's skin.
The nurse orients the adaptor 22 with the clip 34 positioned to the side of
the tubular body 25 (i.e., with the
support arm 32 extending in the lateral direction) and locates the adaptor
support arm 32 above the series of retainer slots
50 with the latch 36 positioned distal of the retainer distal end.
The nurse then snaps the adaptor 22 into the retainer 20 located proximal of
the pad notch 68. In doing so, the
adaptor 22 is pressed between. the longitudinal walls 46 of the retainer 20
with the support arm 32 extending in a lateral
direction. As the nurse presses the adaptor 22 into the retainer 20, the
chamfered edges 58 around the slots 50 of the
longitudinal wall 46 guide the support arm 32 into one of the slots 50.
As mentioned above, the opening 47 of the channel 46 has a smaller width
measured in the lateral direction than
the diameter of the tubular body 25. The lateral walls 46 thus deflect
outwardly in a lateral direction. Once the tubular
body 25 of the adaptor 22 rests within the central channel 44 of the retainer
20, the lateral walls 46 spring back to snap
the adaptor 22 in place. The walls 46 of the retainer 20 thus prevent
unintentional transverse and lateral movement of the
adaptor 22.
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CA 02678253 2009-09-08
In this position, the protuberance 40 of the adaptor 22 either rests either in
a slot 50 or in the relief 60, proximal
of the slot 50 through which the support arm 32 passes. The protuberance 40
engages a portion of the longitudinal wall
46, which forms either the relief 60 or the slot 50, to prevent the clip 34
from pivoting reiative to the tubular body 25.
The protuberance 40 thus ensures that the latch 36 maintains engagement with
the catheter hub 30.
The slot 50 through which the support arm 32 passes prevents the adaptor 22
from sliding in the longitudinal
direction. That is, the slot 50 prevents longitudinal displacement of the
adaptor 22 when secured within the central
channel 44.
The ergonomic design of the retainer 20 provides for a variety of positions of
the adaptor 22 in the retainer 20
so that the retainer 22 is not technique or position sensitive. That is, a
nurse can simply press the adaptor 22 into the
retainer 20, irrespective of the side on which the support arm 32 is located,
and irrespective of the position of the support
arm 32 relative to a particular slot 50. So long as the support arm 32 is
positioned above the series of slots 50, the
chamfered edges 58 of the wall 46 will guide the support arm 32 into a slot
50. The protuberance 40 of the adaptor 22
also fits within an adjacent slot 50 or the relief 60.
With the support arm 32 extending through a slot 50 of the retainer 20, the
adaptor 22 lies in a "low profile"
position. That is, the support arm 32 of the adaptor 22 extends in the lateral
direction to reduce the overall height of the
anchoring system 10, as measured in the transverse direction. This position of
the adaptor 22 reduces the risk of the
system 10 interfering with surrounding action. The retainer 20, however,
allows the adaptor 22 to rotate either to a
position in which the support arm 32 extends in the transverse direction, or
to a position 180 for the original position to
locate the adaptor clip 34 on the opposite side of the retainer 20.
Once in the low profile position, the adaptor 22 will normally remain in this
position until the adaptor 22 and its
associated tubing 12 are removed and replaced by another.
As Figure 1 illustrates, the nurse may also form a safety loop in the fluid
supply tubing 12, as known in the art,
and secure the safety loop to the patient by inserting a portion of the tubing
12 into the tube clip 24. The safety loop
absorbs any tension applied to the fluid supply tube to prevent the adaptor 22
andlor catheter 14 from being pulled.
A nurse may use the slide clamp 78 to remove the adaptor body 25 from the
retainer 20. The nurse inserts the
tab 82 of the slide clamp 78 into the keyway groove 62 on the proximal end of
the retainer 20. Because the tab 82 has a
larger width than the depth of the key-way groove 62, measured in the
transverse direction, the tab 62 pries the tubular
body 25 from the central channel 44 as the nurse inserts the tab 82 into the
key-way groove 62 in the distal direction.
The nurse may further use the slide clamp 78 to leverage the proximal end of
the tubular body 25 out the upper opening 47
of the retainer 20. Having displaced the proximal end of the adaptor 22 from
the retainer 20, the nurse may easily remove
the adaptor distal end from of the retainer 20. Alternatively, the nurse may
also remove the tubular body 25 by lifting up
on the tubing 12 while holding down the pad 16 or the retainer 20 with the
other hand.
Figures 6 through 8 illustrate the catheter anchoring system 10a particularly
suited for arterial catheterization.
Because of the criticality of the incident angle (i.e., the angle at which the
catheter 14a projects into the patient) at which
CA 02678253 2009-09-08
the catheter 14a must be maintained, it is advantageous to precisely position
the retainer 20a so that the retainer 20a
holds the catheter 14a at the desired incident angle. The desired range of
incident angle commonly is about 5=30 for
arterial catheterization. The incident angle preferably ranges between about
15 and about 25 , and more preferably
equals about 22 .
A nurse inserts the catheter cannula 14a into an artery in a similar manner to
that described above in connection
with intravenous catheterization. The nurse subsequently connects the adaptor
22a to the indwelling catheter 14a as
previously described. The nurse also attaches the flexible pad 16a to the
patient in a like manner to that described above.
If desired, the nurse can remove one of the wings 140 of the pad 16a before
attaching the pad 16a to the patient, by
tearing the pad 16a along the perforation line 142.
The nurse orients the adaptor 22a with the clip 34a positioned to the side of
the tubular body 25a (i.e., with the
support arm 32a extending in the lateral direction) and locates the adaptor
support arm 32a above the series of retainer
slots 50a with the latch 36a positioned distal of the retainer distal end. If
the nurse positions pad 16a too close to or too
far from the indwelling catheter 14a, the nurse can slide the retainer 20a in
the desired direction to locate the retainer
slots 50a beneath the adaptor support arm 32a.
The nurse then snaps the adaptor 22a into the retainer 20a located proximal of
the pad notch 68a. In doing so,
the chamfered edges 58a around the slots 50a of the longitudinal wall 46a
guide the support arm 32a into one of the slots
50a. The retainer 20a automatically slides longitudinally to precisely
position a corresponding slot 50a beneath the
support arm 32a. The adaptor 22a thus snaps into the retainer 20a without
causing the catheter 14a to move
substantially.
The tubular body 25a contacts the protuberance 122 of the finger 120 and
causes the finger 120 to deflect
downward as the adaptor tubular body 25a snaps into the central channel 44a.
In turn, the pawl 114 engages the series
of teeth 110 which prevents longitudinal movement of the retainer 20a while
holding the adaptor 20a. If the nurse
removes the adaptor 22a -- preferably by using the slide clamp tab 82a -- the
finger 120 springs back to its undeflected
state and the retainer 20a freely slides over the rail 96. The pawl 114
normally does not engage the series of teeth 110.
The ability to precisely position the retainer 20a beneath the catheter
adaptor 22a connected to the catheter
14a, enables the nurse to hold the catheter 14a in a stable position and
ensures that the retainer 20a will hold the adaptor
22a, and thus the catheter 14a, at the precise incident angle. Without the
ability to adjust the longitudinal position of the
retainer 20a, the nurse may perform a series of position iterations before
properly locating base pad 16a, and thus the
retainer 20a, relative to the indwelling catheter 14a.
For epidural catheterization, an anesthesiologist, for example, inserts the
distal end of microbore tubing 126 into
the epidural space. The proximal end of the microbore tubing 126
conventionally includes a Toughy-Bourst adaptor 144 or
other adaptor device to couple with the fluid supply tube 1 2b transporting
the anesthesia. It is imperative that the
connection between the microbore tubing 126 and the fluid supply tubing 144
remain intact, and that the distal end of the
microbore tubing 126 remains in place. For if the epidural space is exposed to
air-borne microbes, meningitis may develop.
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CA 02678253 2009-09-08
Thus, a secure interconnection between the microbore tubing 126 and the fluid
supply 12b should exist, and the microbore
tubing 126 should be isolated from any tension placed on either the fluid
supply tube 12b, as well as the adaptor 22b.
Figures 9 and 10 illustrate the catheter anchoring system 10b particularly
suited for epidural catheterization. A
doctor uses the present anchoring system 10b in a manner similar to that
described above in connection with intravenous
catheterization, with the exceptions that doctor connects the adaptor 22b to
microbore tubing 126 and adheres the base
pad 16b to the patient's torso.
The doctor subsequently snakes the microbore tubing 126 through the S-clip 124
by first pressing the tubing
126 between a retainer 134 and the wall 130, and then wrapping the tubing 126
between the first and second retainers
134. Light pressure forces the tube 126 between the retainers 134. The doctor
then wraps the tube 126 back between
the second retainer 134 and the second wall 130, and presses the tube 126
therebetween. The S-clip 124 secures the
microbore tube 126 in place and isolates the microbore tube 126 from tension
placed on the adaptor 22b andlor the fluid
supply tube 12b with the microbore tube 126 inserted accordingly.
Additional Embodiments
As mentioned above, it is contemplated that other types of adaptors in
addition to the one disclosed above can
be used as well with the present catheter anchoring system. Figures 11 and 12
illustrate a catheter anchoring system 10c
in accordance with a further embodiment of the present invention which
includes a different catheter adaptor style. Where
appropriate, like numbers with a "c" suffix have been used to indicate like
parts of the embodiments for ease of
understanding.
Like the catheter anchoring systems described above, the present catheter
anchoring system 10c principally
comprises a flexible anchor pad 16c having an adhesive bottom side 18c, which
attaches to the skin of the patient. The
pad 16c supports a retainer 20c. The retainer 20c is configured to receive and
secure in place a catheter adaptor 22c
which connects to an indwelling catheter 14c. The pad 16a may also support a
tube clip 24c which is used to retain a
portion of the tubing 1 2c.
Figure 11 illustrates the adaptor 22c as comprising a generally tubular body
25c defined between a distal end
26c and a proximal end 28c. The proximal end 28c is adapted to receive a
distal end of the tube 12c. In an exemplary
embodiment, at least a portion of the fluid supply tube 12c is permanently
attached to the body proximal end 28c.
The distal end 26c is configured to engage a proximal end of the indwelling
catheter 14c (not shown). Although
Figures 11 and 12 illustrate the distal end 26c of the adaptor 22c as having a
frusto-conical shape configured to engage a
standard lure-type catheter hub 30c (not shown), it is contemplated that the
distal end 26c could be configured as well to
engage other types of connectors.
Figure 14 illustrates an alternative configuration of the distal end 26d of
the catheter adaptor 22d. Again, for
consistency, like numbers with a "d" suffix have been used to indicate like
parts of the catheter adaptor of Figure 11 and
the catheter adaptor of Figure 14.
17
CA 02678253 2009-09-08
The catheter adaptor 22d includes a standard lure-lock type fitting 220
attached to the body 25d of the catheter
adaptor 22d so as to circumscribe the distal end 26d of the catheter adaptor
22d. The lure-lock fitting 220 preferably is
attached in a manner which permits the fitting 220 to be rotated about the
catheter adaptor body 25d. It is contemplated,
however, that the distal end of the adaptor could comprise a female lure-lock
type connector (i.e., a hub including nubs or
threads on its external surface) as well if required by a particular
application.
In the illustrated embodiment, the fitting 220 has a generally tubular shape
with a closed proximal end 222. The
closed end 222 includes an aperture 224 of a sufficient size to receive a
portion of the adaptor body 25d, as described
below. The fitting 220 includes conventional internal threads 226 in order to
engage corresponding threads of a
conventional female lure-lock fitting (not shown).
The adaptor body 25d desirably includes an annular groove 228 which receives a
portion of the closed end 222
of the fitting 220 to interconnect the fitting 220 and the adaptor body 25d.
This interconnection also permits the fitting
220 to be rotated about the adaptor body 25d.
To assemble the catheter adaptor 22d, the conical shaped distal end 26d of the
body 25d is inserted into the
aperture 224 of fitting closed end 222. The body 25d is then forced into the
fitting 220 to slightly deflect the closed end
222 until the closed end 222 snaps into the annular groove 228 of the body
25d. In this position, the body 25d captures a
portion of the fitting 220 to couple these elements together.
With reference to Figure 11, the adaptor 22c includes at least one annular
collar 200 interposed between the
proximal and distal ends 28c, 26c of the tubular body 25c. The adaptor 22d of
Figure 14 also includes a like annular collar
200d. It is contemplated that the collar 200 of the adaptor 22c of Figure 11
and the collar 200d of the adaptor 22d of
Figure 14 will be substantially identical, and, thus, the description herein
will be understood as applying equally to both
embodiments.
The annular collar 200 flares radially outwardly and circumscribes the tubular
body 25c. The annular collar 200
has a thickness measured in a longitudinal direction which is slightly less
than a width of a slot 50c in a retainer wall 46c
so that the collar 200 fits within the slot 50c of a retainer wall 46c, as
discussed in detail below.
The adaptor 22c is preferably formed of a durable, biocompatible plastic
material. The adaptor 22c more
preferably is formed of clear plastic so a nurse can see bubbles or backflow
through the adaptor 22c. In an exemplary
embodiment, the adaptor is formed of polycarbonate by injection molded;
however, those skilled in the art will readily
appreciate that the adaptor can be formed by other construction methods known
in the art.
Figures 11 and 12 also illustrate the retainer 20c which is substantially
identical to the retainer 20 described
above. The retainer 20c comprises a central channel 44c interposed between a
pair of opposing longitudinal walls 46c.
The central channel 44c extends through the retainer 20c along an axis which
is generally parallel to a longitudinal axis of
the retainer 20c.
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CA 02678253 2009-09-08
The central channel axis 44c has a generaily circular cross-sectional shape
which is truncated at an upper end to
form an opening 47c. The central body 44c has a diameter sized to receive the
tubular body 25c of the catheter adaptor
22c. In a preferred embodiment, the diameter of the central channel 44c
generally matches that of the tubular body 25c.
In cross section, the central channel 44c extends through an arc greater than
180 about the channel axis such
that the lateral length of the opening 47c is less than the diameter of the
central channel 44c. In an exemplary
embodiment, the cross=sectional shape of the central channel 44c extends
through an arc of about 200. about the channel
axis.
As best seen in Figure 13a, the channel axis is desirably skewed relative to a
base surface 48c of the retainer
20c. An incident angle 0 formed between the base surface 48c and the channel
axis is less than 45 . The incident angle 0
desirably ranges between 5 and 30 . In an exemplary embodiment for intravenous
use, the angle 0 preferably
approximately equals 7 .
The longitudinal walls 46c are substantially identical. Each wall 46c has a
thickness measured in the lateral
direction less than the length of the support arm 32 of the adaptor 22, as it
is desirable for the present retainer 20c to
accept both the above-described adaptor 22 which comprises a support arm 32
connected to a clip 34, as well as the
present adaptor 22c which comprises an annular collar 200. Preferably, the
thickness of the wall 46c measured in the
lateral direction is greater than the distance measured radially by which the
collar 200 extends beyond the exterior surface
of the tubular body 25c (i.e., a radial height). The length of each wall 46c,
as measured in the longitudinal direction, is
preferably coextensive with the length of the retainer 20c.
Each wall 46c comprises a unrform series of slot 50c. The series comprises at
least two (2) slots 50c and not
more than twenty (20) slots 50c. More preferably, the series comprises less
than seven (7) slots 50c. In an exemplary
embodiment, as illustrated in the figures, the series comprises four (4) slots
50c.
As discussed above, each slot 50c is sized to receive the collar 200 of the
adaptor 22c, as well as the support
arm 32 of the catheter adaptor 22, to prevent longitudinal displacement of the
respective adaptor 22, 22c. Each slot 50c
desirably has a rectangular shape. As seen in Figure 12, the slots 50c extend
from an exterior surface 52c, through the
wall 46c, and open into the central channel 44c. The width of the slot 50c, as
measured in the longitudinal direction, is
desirably slightly greater than the width of the support arm 32 and the width
of the collar 200.
As illustrated by Figure 13a, each slot 50c extends in the transverse
direction from an upper edge 54c of the
longitudinal wall 46c to a point below the bottom 56c of the central channel
44c. The height of the slot 50c, as measured
in the transverse direction, is thus greater than the distance between the
upper edge 54c and the channel bottom 56c of
the retainer 20c. As seen in FigurE 13b, the retainer 20c further includes a
series of lateral grooves 202 which extend
between opposing slots 50c and extend into the retainer 20c from the channel
bottom surface 56c. The opposing slots
50c and groove 202 thus form a lateral channel which extends through the
retainer 20c in the lateral direction and cuts
into the retainer 20c from the upper edge 54c to a point below the channel
bottom surface 56c. The groove 202 desirably
is sized to receive a portion of the collar 200 such that with the tubular
body 25c positioned within the central channel
19
CA 02678253 2009-09-08
44c, the collar 200 extends between opposing slots 50c and into the groove
202. Thus, the groove 202 has a depth,
measured between the lower surface 56c of the central channel 44c and the
bottom of the groove in transverse direction,
which is greater than the radial height of the annular collar 200.
Figure 13b illustrates that the spacing S between the slots 50c, on center,
desirably equals about half the distal
L (see Figure 2) between the support arm 32 and the protuberance 40 of the
catheter adaptor 22. The position of the slots
in relation to the proximal and distal ends 26c, 28c of the retainer 20c is
desirably configured in accordance with the
spacing and positioning discussed above in connection with the above-described
retainer 22, such that the present retainer
22c can be used with the above-described adaptor 22, including a clip 34.
Figures 11 and 13a illustrate the upper edge of each longitudinal wall 46c
which comprises a series of chamfers
58c formed and positioned as disclosed above in connection with the retainer
20. As discussed above, the chamfers 58c
slope downwardly towards the slot 50c to facilitate the insertion of either
the support arm 32 of the above-described
catheter adaptor 22 or the annular collar 200 of the present catheter adaptor
22c into the slot 50c.
As Figures 11 -13b illustrate, each longitudinal wall 46c may further comprise
a relief 60c disposed on the
proximal end of the retainer 20c. The configuration and position of the relief
60c desirably is in accordance with the above
description of the retainer 20. Figure 11 further illustrates that the
retainer 20c may additionally comprise a key-way
groove 62c to facilitate removal of the catheter adaptor 22c from the retainer
20c, as discussed above. The key-way
groove 62c desirably is also positioned and configured in accordance with the
above disclosure in connection with the
retainer 20.
The retainer 20c is made of relatively stiff plastic material, but is somewhat
flexible such that the adaptor 22c
forces the upper edges 54c of the longitudinal waits 46c outwardly when a
nurse presses the adaptor 22c into the central
channel 44c of the retainer 20c. The retainer 20c is desirably formed of
polycarbonate by injection molding. When the
adaptor 22c sits within the central channel 44c, the upper edges 54c of the
walls 46c snap inwardly to their original
position to securely hold the adaptor 22c within the retainer 20c.
An adhesive preferably attaches the retainer 20c to the anchor pad 16c.
Alternatively, the retainer 20c may be
attached to the anchor pad 16c by like means as well, e.g., embedding or
otherwise weaving the retainer into the anchor
pad 16c.
Figure 11 illustrates the anchor pad 16c as comprising a flexible, laminate
structure comprising an upper paper or
other woven or non-woven cloth layer 64c and a bottom adhesive layer 1 Bc,
with an inner cellulose foam layer 66c
interposed therebetween. Alternatively, the flexible base pad 16 may comprise
an adhesive bottom layer 18 and an upper
cellulose foam layer. An upper surface of the foam layer is roughened by
corona treating with a low electric charge, as
known in the art. The foam layer 66c forms a cushion between the patient's
skin and the rigid, plastic retainer 20c and
tube clamp 24c. The adhesive layer 18c may comprise a coating of diaphoretic
or nondiaphoretic material, depending upon
the patient's skin condition. A medical grade foam tape with a diaphoretic or
a nondiaphoretic adhesive is available
commercially from NDM Manufacturers.
CA 02678253 2009-09-08
The removable paper or plastic backing (not shown) desirably covers the bottom
adhesive layer 18 before use.
As discussed above and illustrated in Figure 12, the backing is preferably
divided into a plurality of piece and includes tabs
67c to ease removal of the backing from the pad 16. The tabs 67c may include
indicia 69c (e.g., dots, text, arrows, etc.)
to indicate the location at which to grip the corresponding tab 67c when
peeling the removable backing off the pad 16c.
As best seen in Figure 12, the anchor pad 16 desirably has a generally
trapezoidal shape with rounded corners.
A distal edge 206 of the anchor pad 16c desirably has a width, as measured in
the lateral direction, wider than that of a
proximal edge 204. The longer distal edge 206 provides a longer adhesive
surface over a rough contact surface, such as,
for example, over knuckles, vertebrae, or the like. The generally trapezoidal
shape, however, minimizes the overall size of
the anchor pad 16c attached to the patient. The trapezoidal shape also
provides the same surface area as a square pad
with a appearance of a smaller pad. The longitudinal sides 208 of the anchor
pad 16c preferably taper from the proximal
edge 206 to the distal edge 204, and more desirably have concave shapes.
The anchor pad includes a notch 68c positioned along the proximal edge 204 of
the anchor pad 16c and adjacent
to the point of insertion of the catheter cannula. Preferably, the notch 68c
is symmetrically positioned about the channel
axis 44c of the retainer 20c attached to the anchor pad 16c. The notch 68c is
sized to permit visual inspection of the
catheterized site and is large enough to allow for variable placement of the
pad 16c with respect to the insertion site.
That is, the notch 68c is large enough that a nurse is not required to
precisely position the pad on the patient's skin with
respect to the indwelling catheter 14c (not shown).
As seen in Figures 11 and 12, the anchor pad 16c desirably may comprise
indicia 70c sometimes in the form of
an arrow which indicates the proper orientation of the anchor pad 16 in
reference to the catheterized site. When properly
used, the indicia 70c points toward the indwelling catheter 14c (not shown).
The anchor pad 16c preferably supports a clip 24c which secures the fluid
supply tube 1 2c to the anchor pad
16c. As seen in Figure 12, the fluid supply tube 12c is preferably looped back
around in a proximal direction and inserted
into the clip 24c to form a safety loop, as known in the art. The tube clip
24c is desirably configured in accordance with
the above description. The clip 24c may be made in a variety of sizes to
accommodate various calibers of fluid flow tubing
12c.
In use, a nurse typically uses the catheter anchoring system 10c in conneciion
with an indwelling catheter 14c
(not shown). The catheter 14c is inserted into a body lumen, such as a vein,
in accordance with the above description.
The nurse then inserts the distal end 26c of the adaptor 22c into a catheter
hub 30c (not shown) to connect the adaptor
22c to the catheter 14c. The nurse may then secure the adapter 22c to the
catheter 14c by means of the ratchet clip, or
the Iure=lock fitting.
The nurse removes the paper backing which initially covers the adhesive bottom
surface 18c of the anchor pad
16c, as described above, and attaches the anchor pad 16c to the patient's skin
proximate to the indwelling catheter 14c.
The nurse specifically positions the notch 68c of the pad 16c around the
catheter cannula 14c with the indicating arrow
21
CA 02678253 2009-09-08
70c pointing in the direction of the catheter 14c. The nurse generally aligns
the proximal edge 204 of the anchor pad 16c
with the insertion site.
The nurse positions the adaptor 22c above the series of retainer slots 50c,
and snaps the adaptor 22c into the
retainer 20c. In doing so, the adaptor 22c is pressed between the longitudinal
walls 46c of the retainer 20c with the
annular collar 200 extending into opposing slots 50c and into the
corresponding groove 202 of the retainer 20c. As the
nurse presses the adaptor into the retainer 20c, the chamfered edges 58c
around the slots 50c of the longitudinal walls
46c guide the annular collar 200 into the slots 50c. The retainer 20c secures
the adaptor 20c as described above.
With the annular collar 200 positioned in the opposing slots 50c the adaptor
22c is prevented from sliding in a
longitudinal direction.
Like the above-described embodiments of the retainer, the ergonomic design of
the retainer 20c provides for
various positions of the adaptor 22c in the retainer 20c so that the retainer
22c is not technique- or position-sensitive.
That is, a nurse can simply press the adaptor 22c into the retainer 20c,
irrespective of the position of the annular collar 20
relative to a particular slat 50c of the retainer 20c. So long as the annular
collar 200 is positioned above the series of
slots 50c, the chamfered edges 58c of the wall 46c will guide the annular
collar 200 into the slot 50c.
The present embodiment of the retainer 20c, as mentioned above, may also be
used with the above-described
adaptor 22 having the clip 34. A nurse uses the present retainer with the
above-described adaptor 22 in the same manner
as described above in connection with the above-described retainer 20.
If the catheter hub 30 (see Figure 1) is a standard female lure-lock fitting,
the lure-lock fitting 220(Figure 14) of
the adaptor body 22d is rotated with the distal end 26d inserted into the
catheter hub 30 to interlock the corresponding
fittings 222, 30 in the known manner. The catheter adaptor 22d is then used
with the anchoring system in a like manner
to that described above.
The above embodiments illustrate the adaptor with the radially extending
member being affixed to an end of a
tube set or other fluid line. The radially extending member can also be
arranged on the adaptor or fitting that is affixed to
the proximal end of the catheter body. Figures 15a through 15c illustrate this
arrangement.
Figures 1 5a through 15c illustrate a catheterization system configured in
accordance with another embodiment
of the present invention. The catheterization system includes a catheter and
an anchoring system that includes a retainer
and an anchoring pad. Although the anchoring pad has been omitted from Figures
15a through 15c to simplify the
drawings, the anchor pad desirably is constructed in accordance with the above
description and is shaped in the form
shown in Figure 16. Again, for consistency, like numbers with an "e" suffix
have been used to indicate like parts of the
anchoring system of Figures 11 and of 15a-15c. The above description of like
components thus should be understood as
applying equally to the present embodiment, unless stated otherwise.
The catheter desirably includes an elongated tubular body with a tubular
adaptor or fitting attached to the body.
At least one lumen of the adaptor communicates with a corresponding lumen of
the catheter. In the illustrated
embodiment, the adaptor 22e is permanently attached to a proximal end of the
fitting and is configured to cooperate with
22
CA 02678253 2009-09-08
a corresponding adaptor formed on a distal end of a fluid line. The adaptor
22e, however, can be releasably attached to
the catheter body.
In the illustrated embodiment, the tubular adaptor 22e is configured as a
female-component of the coupling
between the catheter body and the fluid line. The adaptor 22e of course can be
configured as the male component of the
coupling. In either case, both the male and female adaptors of the coupling
have corresponding generally frusto-conical
shapes which mate together in a generally fluid tight engagement. The coupling
adaptors also include interengaging
elements that lock together the adaptors. The tubular adaptor 22e of the
illustrated embodiment includes a threaded
coupler 306 formed by an external thread that runs about a proximal end 300 of
a tubular body of the adaptor 22e. The
external thread of the threaded coupler is configured to corresponding to an
internal thread of a spin nut disposed on the
end of the corresponding adaptor (such as the type illustrated in Figure 14).
In the illustrated embodiment, the tubular body of the adaptor 22e includes a
frusto-conical shaped section 304
on the distal side 302 of the threaded coupler 306. The corresponding form of
the adaptor 22e generally corresponds to a
conventional catheter hub, such as the type illustrated in Figure 1.
Unlike a conventional catheter hub, however, the adaptor 22e includes a
radially extending member that projects
from the tubular body. In the illustrated embodiment, the radially extending
member comprises an annular collar 200e that
circumscribes a portion of the frusto-conical shaped section 304 of the
tubular body. The collar 200e is generally
positioned about midway between the proximal and distal ends 300, 302 of the
tubular body; however, it need not be as
illustrated in embodiment of Figure 16.
As understood from Figures 15a through 15c, the retainer 20e defines a central
channel 44e that has a generally
conical shape corresponding to the shape of the adaptor tubular body. The
channel 44e is interposed between a pair of
opposing converging longitudinal walls 46e.
The walls 46e are spaced apart such that there is a variable lateral distance
therebetween. The walls 46e have
a proximal end 300 and a distal end 302, with the proximal end width being
desirably wider than the distal end width.
The central channel 44e extends through the retainer 20e along the
longitudinal axis and between the converging
walls 46e. The channel 44e is similarly of variable lateral dimension as taken
at points along the longitudinal axis
direction.
The central channel 44e has a truncated upper section which gives the channel
a generally U-shape having an
upper opening 47e. The bottom and side surfaces of the channel 44e are arcuate
and substantially match the shape of the
catheter adaptor 22e, which can be received therein. The variable diameter of
the channel 44e is sized to receive the
longitudinal length of the catheter adaptor 22e. Each section of the channel
44e has arcuate shape of a radius of
curvature that generally matches a corresponding section of the catheter
adaptor 22e. In the illustrated embodiment, the
radii of curvature vary along the longitudinal length of the channel 44e;
however, the channel 44e can have generally
uniform radii of curvature, as illustrated by the above embodiments.
23
CA 02678253 2009-09-08
In cross section, as best understood from Figure 15c, the channel 44e extends
through an arc of greater than
180 about the longitudinal axis such that the lateral length of the upper
opening 47e is less than the diameter of the
channel 44e at a given point in the longitudinal direction. In the illustrated
embodiment, the channel 44e desirably extends
through an arc of about 200 about the channel axis.
The retainer also includes at least one slot 50e that lies generally
perpendicular to the longitudinal axis and
extends across the channel 44e to section the channel 44e into a proximal
channel portion and a distal channel portion. In
the illustrated embodiment, the proximal and distal channel portions have
generally equal longitudinal lengths; however,
they need not have the same length. The length of the channel portions though
desirably provides stability to the catheter
adaptor 22e when inserted into the retainer 20e to prevent the catheter
adaptor 22e from yawing (i.e. pivoting relative to
the retainer within a plane parallel to the anchor pad). Each channel section
of the retainer 20e is also sized to receive a
corresponding section of the catheter adaptor 22e. Each slot 50e is sized to
receive the collar 200e of the catheter
adaptor 22e.
The slot 50e has a thickness that substantially matches the thickness of the
adaptor collar 200e. The thickness
of slot 50e, however, is less than the combined longitudinal lengths of the
proximal and distal channel portions. This
dimensional relationship provides further stability to the retained catheter
adaptor 22e when inserted into the retainer 20e.
In the illustrated embodiment, the retainer 20e includes at least two lateral
slots 50e arranged in series (i.e., next
to each other) between the proximal and distal channel portions. The series of
slots desirably includes between two (2)
and twenty (20) slots. More preferably, the series comprises less than seven
(7) slots. The illustrated embodiment shows
two (2) slots.
As described above, each slot 50e is sized to receive a portion of the adaptor
annufar collar 200e to prevent
longitudinal displacement of the catheter, as discussed in detail above. Each
slot 50e desirably has a rectangular shape
and extends from an exterior surfaces 52e through the walls 46e, and across
the central channel 46e. The width of each
slot 50e (measured longitudinally) is desirably slightly greater than the
width of the fitting 304, measured in the
longitudinal direction to receive the fitting 304, as discussed above.
The retainer 20e also desirably includes a relief 308 formed on the bottom of
the channel 44e. The relief 308 is
sized to receive a portion of the collar 200e when piaced within one of the
slots 50e.
Finger platforms 310 extend from the side walls 46e of the retainer 20e. The
finger platforms 310 are sized and
configured to enable allow a health care provider to press the retainer 20e
against the skin of the patient while pulling up
on the catheter adaptor 22e or on the adaptor to which it is connected, when
disengaging the catheter adaptor 22e from -
the retainer 20e.
So configured, in addition to the interengagement between the slots 50e and
annular collar 200e, longitudinal
movement of the catheter in the proximal-to-distal direction is further
inhibited by cooperation between the conical-shaped
channel 44e and frusto-conical shaped fitting 304. That is, when an applied
force directs the fitting 304 in the distal
direction, the fitting 304 advances until contact with a section of the walls
46e (which are of uniformly narrower diameter
24
CA 02678253 2009-09-08
as measured toward the proximal end of the walls 46e). When contact is made,
the fitting 304, and catheter which is
attached thereto, is restricted from further distal movement.
Figure 16 illustrates another embodiment of the catheterization system similar
to that described above in
connection with Figures 15a-15c. Accordingly, like reference numerals with
a"f" suffix have been used to indicate similar
components between these embodiments. The above description of like components
thus applies equally to the present
embodiment, unless stated otherwise.
In the illustrated embodiment, the conical shaped section of the catheter hub
304 has an irregular step in
diameter between the side proximal 300f of the collar 200f and the side distal
302f of the collar 200f. That is a minimum
diameter of the conical section on the side proximal 3001 the collar 200f is
larger than a maximum diameter of the conical
section on the side distal 302f of the collar 200f.
The retainer 20f has a shape corresponding to that of the conical section of
the catheter adaptor 22f. The
proximal 300f channel portion has a radius of curvature generally matching
that of the proximal 300f side of the adaptor
conical section. And the distal 302f channel portion has a radius of curvature
generally matching that of the distal 302f
side of the adaptor conical section. As such, a minimum diameter of the
proximal 300f channel section is larger than a
maximum diameter of the distal 302f channel section.
The retainer 20f is mounted atop an anchor pad 16f with its upper opening 47f
being exposed and facing away
from the anchor pad 16f. The construction of the anchor pad 16f and the
retainer 20f, as well as the attachment of the
retainer 20f to the anchor pad 16f, are in accordance with the above
description. The anchor pad 16f also supports a tube
clip 24f, as illustrated in Figure 16.
As similar to the above embodiment, the present catheterization system is used
by first connecting the catheter
to a fluid line (be it supply or drainage). The catheter is inserted into a
body lumen, such as a vein, in accordance with the
above description. The nurse then inserts a distal end of one of the coupling
adaptor 22c into a catheter adaptor to
connect together the adaptors. The nurse may then interconnect the adapters by
means of the above-described ratchet
clip, or the lure-lock fitting formed between the threaded coupler on the
proximal end of the catheter adaptor and the spin
nut on the end of the adaptor attached to the fluid tube.
The nurse removes the paper backing which initially covers an adhesive bottom
surface of the anchor pad 16f,
as described above, and attaches the anchor pad 16f to the patient's skin
proximate to the indwelling catheter. The nurse
specifically positions a notch of the pad 16f around the catheter body or
cannula. The nurse generally aligns the proximal
edge of the anchor pad 1 6f with the insertion site.
The nurse positions the adaptor 22f above the series of retainer slots 50f,
and snaps the adaptor 22f into the
retainer 20f. In doing so, the adaptor 20f is pressed between the longitudinal
walls 46f of the retainer 20f with the
ennular collar 200f extending into one of the slots 50f of the retainer 20f.
As the nurse presses the adaptor 22f into the
retainer 20f, chamfered edges 312 around the slots 50f (see Figure 15a) of the
longitudinal walls 46f guide the annular
CA 02678253 2009-09-08
collar 200f into the slots 50f. With the annular collar 200f positioned in one
of the slots 50f, the adaptor 22f is prevented
from sliding in a longitudinal direction.
Like the above-described embodiments of the retainer 20f, the ergonomic design
of the retainer 20f provides for
various positions of the adaptor 22f in the retainer 20f so that the retainer
20f is not technique- or position-sensitive.
That is, a nurse can simply press the adaptor 22f into the retainer 20f,
irrespective of the position of the annular collar
200f relative to a particular slot 50f of the retainer 20f. So long as the
annular collar 200f is positioned above the series
of slots 50f, the chamfered edges 312 of the wall will guide the annular
collar 200f into the slot 50f.
Figures 17 and 18 illustrate a catheterization system configured in accordance
with another embodiment of the
present invention. Like the other embodiments of the catheterization system,
this embodiment includes a catheter and an
anchoring system that includes a retainer and an anchoring pad. Again, for
consistency, like numbers with an "g" suffix
have been used to indicate like parts of the anchoring system of Figures 11
and of 16. The above description of like
components thus should be understood as applying equally to this embodiment,
unless stated otherwise.
The present embodiment, like the previous embodiments, utilizes the concept of
providing an adaptor and retainer
which cooperate with each other to secure the catheter to the body of a
patient and inhibit movement of the catheter in
the longitudinal, transverse and lateral directions. Also, like the previous
embodiments, the anchoring system can include
the concept of not being position or technique sensitive. That is, the medical
attendant can simply locate the catheter
adaptor generally above the retainer and press the adaptor into the retainer.
Engagement thus requires only coarse
alignment of the adaptor with the retainer.
Figure 17 shows the retainer 20g comprising a longitudinal channel 44g formed
between a pair of substantially
parallel walls 46g and configured to receive the tubular body of the adaptor
22g in a snap fit manner. The construction of
the channel thus is similar to that described above and about a longitudinal
axis L.
The retainer 20g additionally comprises at least one projection or
protuberance 400 that extends from one of the
walls 46g toward the longitudinal axis in the lateral direction. The
projection 400 is sized and configured to cooperate
with a recess on the catheter adaptor 22g, as explained below. The projection
400, however, can extend into the channel
44g toward the longitudinal axis in the transverse direction.
In the illustrated embodiment, the retainer 20g includes a plurality of
projections 400. In one mode, two
projections are positioned across from each other on opposite walls 46g. The
set of projections 400 thus oppose each
other. The retainer 20g also desirably includes a plurality of projection sets
400 which are spaced along a length of the
channel 44g. The multiple projection sets 400 thus provide multiple positions
in which the adaptor 22g can occupy within
the retainer 20g, so as to require only coarse alignment between the retainer
20g and the adaptor 22g before engagement.
Both laterally and transversely extending projections 400 can be used with the
retainer.
The projections 400 desirably are positioned between a first portion of the
channel 44g and a second portion of
the channel 44g. In the illustrated embodiment, one channel portion is formed
at a proximal end of the channel 44g and
26
CA 02678253 2009-09-08
the other end is formed at a distal end of the channel 44g. Each of the
channel portions desirably are sufficiently long and
support a sufficient length of the adaptor 22g so as to prevent the adaptor
22g from rocking.
Each projection 400 desirably has sufficient thickness or bulk so as to resist
nominal applied forces, i.e. not
break when the medical attendant presses on it. Also, the portion of the
projection 400 that projects into the channel 44g
is of sufficient lateral or transverse dimension to inhibit movement of the
catheter adaptor 22g in the longitudinal direction,
without inhibiting placement of the catheter adaptor 22g into or out of the
channel 44g. That is, the projections 400
extend into the channel by a sufficient amount to engage with corresponding
structure on the catheter adaptor 22g, as
described below.
In the illustrated embodiment, each projection 400 has generally a rectangular
shape in a plane generally parallel
to the retainer base 48g. Thus, the projections 400 generally form a series of
square teeth along a section of each wall
46g at an upper rim of the channel 44g. The projection 400, however, can be
configured in a wide variety of other shapes,
including, but not limited to, semi-circular, square, curvilinear, triangular
or the like. Thus, the projection 400 may be linear,
as illustrated, or curved or curvilinear to suit a particular application, so
as to inhibit migration of the catheter adaptor 22g
in the longitudinal direction.
Below the upper rim of the channel 44g, each projection tapers back toward the
corresponding side wall 46g. In
the illustrated embodiment, this taper 406 generally follows an arcuate path
that desirably corresponds to a surface to the
adaptor 22g, as described below. The projections 400, however, can extend
about the entire arc of the channel 44g (i.e.,
down one side wall, across the bottom of the channel and up the other side
wall) or the projections 400 can extend
downward to the channel bottom (Figure 18).
As noted above, the projections 400 are advantageously sized and configured to
cooperate with a corresponding
recess(es) on the catheter adaptor 22g. Without limitation, the catheter
adaptor 22g can be a fitting on the end of either
the fluid tube, as shown in Figure 17, or the catheter as shown in Figure 18
(e.g., a catheter hub).
In one mode, the projections 400 fit into the recess(es) and engage the sides
of the recess(es) so as to inhibit
longitudinal movement of the adaptor 22g relative to the retainer 20g. In the
illustrated embodiment, the adaptor 22g
includes a piurality of annular grooves or depressions 408 (e.g., three
grooves); however, any number of annular grooves
408 can be used with the adaptor 22g. In order to accommodate the adaptor 22g
in multiple positions within the retainer
20g, however, the number of projection sets 400 should be less than the number
of grooves 408.
Each annular groove 408 is interposed between the proximal and distal ends
28g, 26g of the adaptor 22g and
extends radially inward while circumscribing the adaptor 22g. Each annular
groove 408 also has a thickness measured in
the longitudinal direction which is slightly less than the longitudinal length
of the projection 400 so that at least a portion
of the annular depression 408 fits around the projection 408 of the retainer
wall 46g, as described above.
Each annular groove 408 thus defines an arcuate surface on the exterior of the
adaptor 22g. In the illustrated
embodiment, the radius of this arcuate surface desirably is not greater than
the radius of curvature followed by the
corresponding projection(s) 400 as it tapers toward the respective wall 46g,
as noted above.
27
CA 02678253 2009-09-08
Figure 18 is generally similar to Figure 17 except that the retainer 20g is
configured to receive a frusto-conical
shaped section 304g of the adaptor 22g, rather than an adaptor 22g having a
uniform diameter, as shown in Figure 17.
To form the snap fit engagement between the retainer 20g and tapered adaptor
22g, the channel 44g extends through the
retainer 20g along the longitudinal axis and between converging walls 46g,
thus forming a tapered or stepped region. The
illustrated embodiment also shows four projections 400 formed on the retainer
20g, however, it is understood that any
suitable number of projections (2-20) can be used with the retainer 20g.
The present embodiment of the catheterization system is used by first catheter
is inserted into a body lumen,
such as a vein, in accordance with the above description. The medical
attendant then connects the catheter adaptors
together so as to attach the catheter to the fluid line. The medical attendant
may then interconnect the adapters by
means of the above-described ratchet clip, or the lure-lock fitting formed
between the threaded coupler on the proximal end
of the catheter adaptor and the spin nut on the end of the adaptor attached to
the fluid tube.
The medical attendant positions the adaptor 22g above the series of retainer
projections 400, and snaps the
adaptor 22g into the retainer 20g. In doing so, the adaptor 22g is pressed
between the longitudinal walls 46g of the
retainer 20g with at least a portion of the annular depression 408 receiving a
corresponding projection 400. With at least
a portion of the annular depression 408 positioned around one of the
projections 400, the adaptor 22g is inhibited from
moving in a longitudinai direction. The medical attendant then removes the
paper backing which initially covers an
adhesive bottom surface of the anchor pad 16g and attaches the anchor pad 16g
to the patient's skin proximate to the
indwelling catheter, as described above.
As previously explained, the ergonomic design of the retainer 20g provides for
various positions of the adaptor
22g in the retainer 20g so that the retainer 20g is not technique or position
sensitive. That is, a medical attendant can
simply press the adaptor 22g into the retainer 20g, irrespective of the
position of the annular depression 408 relative to a
particular projection 400 of the retainer 20g. Further, so long as the annular
depression 408 is positioned above the series
of projections 400, the chamfered edges 31 2g of the wall 46g will guide the
annular depression around at least a portion
of the projection 400.
Although this invention has been described in terms of certain preferred
embodiments, other embodiments
apparent to those of ordinary skill in the art are also within the scope of
this invention. It is also understood that various
aspects of one embodiment can be interchanged with other embodiments.
Accordingly, the scope of the invention is
intended to be defined only by the claims which follow.
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