Note: Descriptions are shown in the official language in which they were submitted.
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ANCHORING SYSTEM FOR A CATHETER OR THE LIKE
Background of the Invention
Field on the Invention
The present invention relates in general to an anchoring system for securing a
medical article to a patient and, in
particular, to an anchoring system for securing a catheter or other elongated
medical article to a patient to inhibit
movement or migration of the catheter or medical article relative to the
patient.
Descriation of Related Art
It is very common in the treatment of patients to utilize catheters to
introduce fluids and medications directly into
the patient or to withdraw fluids from the patient. For example, one catheter
utilized to introduce fluids into a patient is a
mid6ne catheter.
In many cases, the catheter remains in place for several days or weeks. In
order to secure the catheter in position
at the insertion site, a heahh care provider often secures the catheter to the
patient using tape. That is, the health care
provider commonly places long pieces of tape across a section of the catheter
near the insertion site in a crisscross pattern
to secure the catheter to the patient's skin. This securement inhibits
movement of the catheter relative to the insertion
site, as well as prevents the catheter from snagging on the bed rail or other
objects.
Tape, however, often collects dirt and other contaminates. Normal protocol
therefore requires periodic (e.g.,
daily) tape changes to inhibit bacteria and germ growth at the securement
site. Frequent tape changes, however, create the
problem of excoriation of the patient's skin. Additionally, valuable time is
spent applying and reapplying the tape. Further,
because many health care providers find the taping procedure difficuft and
cumbersome when wearing latex gloves, they
often remove their gloves when taping. Not only does this further lengthen the
taping procedure, but it also subjects the
health care provider to possible infection. Moreover, even if health care
providers remain gloved, contact between the
adhesive surface of the tape and the latex gloves causes micro-holes in the
gloves, which subjects the health care provider
to possible infection.
As an altemative to tape securement, some catheters include an integrated or a
movable flexible claim with
winged extensions. These extensions are sutured to the patient's skin in order
to secure the catheter in position at the
insertion site. In other apphcations, the flexible claim is covered by a rigid
box claim, which receives the catheterlclamp
combination in a friction-fit manner. The rigid box clamp and the flexible
clamp have lateral, aligned holes in them, which
allow the combination to be sutured to the patient's skin. Although this
technique securely attaches.the catheter to the
patient, it obviously is painful and uncomfortable for the patient. This prior
retention procedure is also time consuming and
inconvenient, poses the risk of needle-stick to the health care provider, and
risks suture-site infection to the patient.
In addition, suture material tends to exhibit poor gripping on medical tubes
and can cut through the winged
extension of the flexible clamp, if a rigid clamp is not used. The use of a
rigid clamp, however, complicates the securement
procedure by adding yet another component that can be dropped on the floor and
become unsterile. In addition, the sutured
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securement of the flexible clamp or the flexible/rigid clamp assembly, does
not permit easy release of the
catheter from the patient for dressing changes and insertion site cleansing.
Summary of the invention
An aspect of the present invention involves a simply-structured anchoring
system that secures an
elongated medical article (e.g., a catheter) in a fixed position relative to
an insertion site and resists tugs on
the medical article, while facilitating intentional release of the medical
article from the anchoring system for
dressing changes or other servicing. Tools, such as hemostats or surgical
clamp, need not be used to
release the medical article from the anchoring system.
In one mode, the anchoring system comprises an anchoring pad having a first
surface and a
second surface. The second surface includes an adhesive layer that covers at
least a portion of the second
surface. A retainer is mounted on the first surface of the anchor pad for
receiving a portion of the medical
article. The retainer includes a base that is attached to the first surface
and at least one post that extends
from the base. The post has a securing portion, which is arranged toward an
outer end of the post. At least
one clip is also formed on the retainer. The clip is sized and configured to
engage at least a portion of the
medical article.
Another aspect of the present invention involves an anchoring system for
securing an elongated
medical article to a patient. The medical article includes at least one
aperture. The anchoring system
comprises an anchor pad and a retainer mounted to the anchor pad. The retainer
includes a first retention
member that is positioned generally upright relative to the anchor pad. The
first retention member is
configured to be inserted through the corresponding aperture of the medical
article. The retainer also
includes a second retention member that is coupled to an anchor pad. At least
a portion of the second
retention member is positioned to lie generally normal to the first retention
member, and is spaced from the
anchor pad by a distance so dimensioned to permit at least a section of the
elongated medical article to be
placed between the portion of the second retention member and the anchor pad.
In accordance with another aspect of the present invention, a method of
securing a medical article
to the body of a patient, wherein the medical article includes an elongated
body with pliable wings that
extend out from the body, with each wing including at least one suture hole,
is provided. The method
involves providing a retainer that has at least first and second posts, which
are spaced apart. A clip of the
retainer is positioned to the side of the post. The first post is inserted
into one of the suture holes of the
pliable wings of the medical article. The pliable wings are stretched so as to
position that other suture hole
over to the second post. The stretched wing is then hooked over the second
post so as to insert the second
post into the corresponding suture hole. A section of the elongated body is
inserted into the clip and
positioned therein so as to inhibit the elongated body from disengaging from
the clip. In the preferred mode,
the retainer is adhered to the body of the patient.
In accordance with an aspect of the present invention, there is provided an
anchoring system for
securing an elongated medical article to a patient, comprising: an anchor pad
having a first surface and a
second surface, the second surface including an adhesive layer that covers at
least a portion of the second
surface; a retainer mounted on the first surface of the anchor pad for
receiving a portion of the medical
article, the retainer having a base attached to the first surface and at least
one past extending from the
retainer base generally along an axis, the post having a securing portion
arranged toward an outer end of
the post; and at least one clip disposed on the retainer base near to the
post, the clip having a receptacle
that is sized and configured to receive at least a portion of the medical
article, and that includes a side
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opening, whereby the portion of the medical article is inserted into the
receptacle of the clip in a direction
that is generally normal to the axis of the post.
According to a another aspect of the present invention, there is provided an
anchoring system for
securing an elongated medical article to a patient, the medical article
including at least one aperture, the
anchoring system comprising an anchor pad and a retainer mounted to the anchor
pad, the retainer
including a first retention member being positioned generally upright relative
to the anchor pad, and being
configured to be inserted through the corresponding aperture of the medical
article, and a second retention
member of which at least a portion is positioned to lie generally normal to
the first retention member being
spaced from the anchor pad by a distance so dimensioned to permit at least a
section of the elongated
medical article to be placed between the portion of the second retention
member and the anchor pad.
According to another aspect of the present invention, there is provided a
securement device for
securing a medical article to a body of a patient, the medical article having
a fitting that includes a pair of
laterally extending wings, the securement device comprising: a mounting layer
having a mounting surface at
least partially covered by an adhesive for attaching the securement device to
the body of the patient; a base
surface accessible from an opposite side of the mounting layer; and first and
second retention surfaces
each being distanced in a transverse direction from the base surface by a
sufficient distance so as to define
a receiving space therebetween, the receiving space being of a size so as to
releasably accept at least a
portion of the medical article, the first and second retention surfaces being
arranged relative to each other
so as to define an entranceway into the receiving space along a longitudinal
axis, the entranceway having a
lateral width less than a width of the fitting.
According to another aspect of the invention, there is provided a method of
securing a fitting that
includes a first lateral wing and a second lateral wing to a body of a
patient, the method comprising:
adhering a securement device to the skin of a patient, the securement device
comprising a mounting layer
having a base surface supporting a first deflectable clip and a second
deflectable clip, at least a portion of
each deflectable clip being arranged generally parallel to the base layer so
as to define a receiving space
therebetween at least when the fitting is retained by the securement device,
the first and second deflectable
clips defining a narrowed entranceway along a longitudinal axis and into the
receiving spaces; moving the
first deflectable clip in a first direction away from a central point between
the receiving spaces to increase a
lateral width of the narrowed entranceway; moving the second deflectable clip
opposite to the first direction
to increase the lateral width of the narrowed entranceway; inserting at least
a portion of the fitting through
the narrowed entranceway so that at least a portion of the first lateral wing
is secured in the corresponding
receiving space and at least a portion of the second lateral wing is secured
in the corresponding receiving
space; releasing the first deflectable clip thereby allowing the portion of
the deflectable clip that is arranged
generally parallel to the base surface to partially cover the first lateral
wing; and releasing the second
deflectable clip thereby allowing the portion of the deflectable clip that is
arranged generally parallel to the
base surface to partially cover the second lateral wing.
According to another aspect of the invention, there is provided a securement
device for securing a
medical article having an elongated body to a body of a patient, the medical
article including at least one
laterally extending surface, the securement device comprising: an anchor pad
having a mounting surface at
least partially covered by an adhesive layer for attaching the securement
device to the patient's body, and a
receiving surface oriented so as to face away from the patient's body, the
receiving surface including a
longitudinally extending section along which at least a portion of the medical
article lies when secured by
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the securement device; and a pair of retention surfaces being spaced in a
transverse direction
from the receiving surface by a sufficient distance to releasably accept a
portion of the medical article
between the pair of retention surfaces and the receiving surface, inner edges
of the pair of retention
surfaces defining an entranceway along a longitudinal axis, the pair of
retention surfaces and the receiving
surface together defining a receiving space, the receiving space having a
lateral dimension which is greater
than a lateral dimension of the entranceway, wherein at least a portion of the
laterally extending surface of
the medical article is retained within the receiving space.
Further aspects, features and advantages of the present invention will become
apparent from the
detailed description of the preferred embodiment that follows.
Brief Description of the Drawings
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The above mentioned and other features of the invention will now be described
with reference to the drawings of
preferred embodiments of the present anchoring system. The illustrated
embodiments of the anchoring system are intended
to illustrate, but not to limit the invention. The drawings contain the
following figures:
Figure 1 is a perspective view of an anchoring system in accordance with a
preferred embodiment of the present
invention and illustrates an exemplary catheter positioned above the anchoring
system;
Figure 2a is a perspective view of a retainer of the anchoring system of
Figure 1;
Figure 2b is a perspective view of another embo(fment of a retainer that can
be used with an anchoring system
similar to that of Figure 1;
Figure 3a is a front elevation view of the retainer of Figure 2a;
Figure 3b is a front elevation view of the retainer of Figure 2b;
Figure 4a is a side elevation view of the retainer of Figure 3a;
Figure 4b is a side elevation view of the retainer of Figure 3b;
Figure 5 is a bottom plan view of the anchor pad of Figure 1;
Figure 6 is a top plan view of the anchoring system of Figure 1 with a
catheter fitting positioned above the
retainer;
Figure 7 is a perspective view of the anchoring system of Figure 1 with the
catheter fitting partially engaged
with the retainer, and
Figure 8 is a perspective view of the anchoring system of Figure 1 with the
catheter fitting fully engaged with the retainer;
and
Figure 9 is a perspective view of an anchoring system in accordance with
another preferred embodiment of the
present invention and llustrates an exemplary catheter positioned above the
anchoring system;
Figure 10a is a perspective view of a retainer of the anchoring system of
Figure 9; and
Figure 10b is a perspective view of another embodiment of a retainer that can
be used with an anchoring system
sinular to that of Figure 9.
Detailed Descriation of Preferred Embodiments of the Invention
The present embodiment of the anchoring system for a medical article is
disclosed in the context of an exemplary
midline catheter. The principles of the present invention, however, are not
limited to midline catheters. Instead, it will be
understood by one of skill in this art, in light of the present disclosure,
that the anchoring system and retainer disclosed
herein also can be successfully utilized in connection with other types of
medical articles, including other types of
catheters, fluid drainage and delivery tubes and electrical wires. For
example, but without limitation, the retainer disclosed
herein can also be configured to receive and secure central venous catheters,
peripheral catheters, peripherally inserted
central catheters, hemodialysis catheters, surgical drainage tubes, feeding
tubes, chest tubes, nasogastric tubes, scopes,
as well as electrical wires or cables connected to external or implanted
electronic devices or sensors, provided that these
device include either an integrated or movable fitting (e.g., a winged
fitting) with one or more securement apertures. One
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skilled in the art may also find additional applications for the devices and
systems disclosed herein. Thus, the illustration
and description of the anchoring system in connection with a midline catheter
is merely exemplary of one possible
application of the anchoring system. The catheter in the illustrated
embodiment includes at least a pliable or deformable
winged fitting, being formed of silicone or latex. An exemplary midline
catheter, in which both the catheter body and the
winged fitting are formed of silicone, is available commercially from Becton,
Dickinson and Cornpany of Sandy, Utah. =
Each of the embodiments described herein employ some basic concepts
characteristic of the anchoring system,
namely releasable engagement of the medical article to a patient. The
releasable engagement is achieved by cooperation
among post, clip and catheter fitting elements. This cooperation allows the
catheter to be disconnected from the anchoring
system, and from the patient, for any of a variety of known purposes. For
instance, the health care provider may want to
remove the catheter from the anchoring system to ease disconnection of the
catheter from the insertion point or to clean
the patient. The disengagement of the catheter from the anchoring system,
however, can be accomplished without
removing the anchoring system from the patient. In addition, the disengagement
can be accomplished without destroying
the anchoring system and without the use of tools, such as, for example, a
hemostat or surgical clamp.
Each of the embodiments described herein also inhibit axial and rotational
movement of the catheter with respect
to the anchoring system. Axial movement is generally inhibited by the holding
effect provided by the posts, which
cooperate with holes in the winged catheter fitting. Rotational movement is
generagy inhibited by the holding effect
provided by the clip, which cooperates with the post to resist movement of the
catheter which could otherwise cause the
catheter fitting to rock, roll, slip or slide from engagement with the posts.
To assist in the description of these components of the anchoring system 10,
the following coordinate terms are
used. A"Iongitudinal axis" is generally parallel to the section of the
catheter 12 retained by the anchoring system 10. A
"lateral axis" is normal to the longitudinal axis and is generally parallel to
the plane of the anchor pad 56. A "transverse
axis" extends normal to both the longitudinal and lateral axes. In addition,
as used herein, "the longitudinal direction" refers
to a direction substantially parallel to the longitudinal axis; "the lateral
direction" refers to a direction substantially parallel
to the lateral axis; and "the transverse direction" refers to a direction
substantially parallel to the transverse axis. Also, the
terms "proximal" and "distal", which are used to describe the present
anchoring system 10, are used consistently with the
description of the exemplary application. Thus, proximal and distal are used
in reference to the center of the patient's body.
A detailed description of the anchoring system 10, and its associated method
of use, now fogows.
With reference now to Figures 1 and 2, an anchoring system 10 is illustrated
and constructed in accordance with
preferred embodiments of the present invention. The system comprises a
retainer 20 and an anchor pad 56. The anchor
pad 56 secures the retainer 20 to a patient's skin. The anchor pad 56 has a
lower adhesive surface 58 which adheres to
the skin of a patient and an upper surface 62 which supports and secures the
retainer 20.
The retainer 20 is sized and configured to accept and retain a section of a
catheter 12 (Figures 6-8) within the
anchoring system 10. The retainer desirably includes at least first and second
retention members. The first retention
member is positioned generally upright relative to the anchor pad 56, and is
configured to inserted through the
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corresponding aperture 74 (e.g., suture hole) of the catheter fitting 14. The
first retention member is configured to engage
a portion of the catheter fitting 14 about the aperture 74 so as to inhibit
unintentional disengagement of the catheter 12
from the first retention member. The second retention member is coupled to the
anchor pad 56. At least a portion of the
second retention member is positioned to lie generally normal to the first
retention member and is spaced from the anchor
pad 56 by a sufficient distance to permit at least a section of the catheter
12 to be placed between the portion of the
second retention member and the anchor pad 56. The second retention member
also is configured to inhibit the received
section of the catheter 12 from puiGng out of engagement with the second
retention member.
In the illustrated embodiment, the first retention member desirably comprises
a post 30 and the second retention
member desirably comprises a clip 48. More preferably, the retainer 20
includes a pair of posts 30 and a clip 48, which is
positioned to the side of the posts 30; however, the retainer 20 can include
any combination of posts and clips in order to
suit a particular appGcation, as those skilled in the art will appreciate. For
instance, the retainer 20 can include a single post
30 positioned between a pair of clips 48 on the retainer. The posts 30 are
sized and configured to releasably accept holes
74 formed in the catheter 12 or a winged catheter fitting 14. The clip 48 is
sized and configured to releasably accept a
portion of the catheter 12.
With reference to Figure 2a, the retainer 20 includes a rigid structure
principally formed by a base 22 In the
illustrated embodiment, the base 22 is integrally formed with the posts 30 and
the clip 48 to comprise a unitary retainer
20. This can be accompGshed in any of a variety of ways well known to those
skiled in the art. For instance, the entire
retainer 20 can be injection molded in order to reduce fabrication costs.
Additionally, as will be apparent from the below description, several features
of the retainer 20 (e.g., a clip, and
to some extent the post(s) and the retainer itself) desirably are flexible.
Suitable rigid but flexible materials include, for
example, but without linitation, plastics, polymers or composites such as
polypropylene, polyethylene, polycarbonate,
polyvinylchloride, acrylonitrile butadiene styrene, nylon, olefin, acrylic,
polyester, as well as moldable silicon, thermoplastic
urethane, thermoplastic eiastomers, thermoset plastics and the like. The
illustrated retainer 20 preferably is formed by
injection molding using a plastic or polymer material. However, other
materials can be utilized, and the retainer 20 can
comprise a non-unitary base, posts andlor clip.
As seen in Figure 2a, the base 22 comprises an elongated body formed
substantiaqy along a piane in the
longitudinal (X=X) and lateral (Y=Y) directions. The base 22 has a distal end
24 and a proximal end 25. The base 22 can be
configured in a wide variety of shapes, such as square, circular, triangular,
curvilinear or the like in order to suit a particular
appfication. For example, the base 22 may be configured similar to the shape
of the anchor pad 56. The illustrated
embodiment shows a generally oval base including first and second lateral
sides 26, 28.
The longrtudinal dimension of the base 22 desirably is sufficiently long to
provide stability to the catheter 12
along its length. That is, the longitudinal length of the retained catheter 12
portion is sufficient to inhibit rocking of the
catheter 12 relative to the retainer 20 (i.e., to prevent the retainer 20 from
acting as a fulcrum for the catheter 12). This
desirably is also true for the lateral danension of the retainer 20. In
addition, the lateral dimension of the base 22 desirably
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allows the health care provider to easily and naturally grip the retainer 20,
as well as provides space on which to locate one
or more posts and one or more clips.
With reference now to Figure 2a, 3a and 4a, one or more posts 30 extend from
the base 22. The illustrated
embodiment includes two posts 30 that extend substantially upright relative to
the base 22. However, the base 22 can
also include additional posts 30 to suit a specific application. For example,
where the retainer 20 is designated to secure a
relatively large catheter 12 or catheter fitting 14, the base 22 can include
four posts arranged at the corners of a
rectangle, for greater stability. Also, three posts can be used to firmly
anchor a Y=site fitting.
Each post 20 includes a shank or shaft 32, attached to and extending from the
base 22. The shaft 32 can have
a variety of lengths and a variety of distances between them, depending upon
the particular application and the particular
fitting 14 with which they are to interact to mount the catheter 12. For
anchoring catheters and medical tubing, each shaft
32 desirably has a length of about 2 mm to 20 mm, and more particularly a
length of about 4 mm; however, longer or
shorter lengths also are possible. The shafts 32 are lateragy spaced at least
wide enough to accommodate the catheter to
be anchored, and in the illustrated embodiments, the shafts 32 are spaced to
accommodate the fitting 14 which secures
the catheter 12. Desirably, the shafts 32 are spaced apart by a distance
slightly greater than the distance between the
corresponding suture holes 74 on the retainer 20. In many application, the
distance between the posts 30 will be between
5 mm and 40 mm, and more particularly generally equal about 20 mm. The shaft
32 of each post 30 has a diameter
sufficient to perform its structural function, as described in more detail
below, and depends upon the material chosen for
the base 22 and posts 30. The llustrated posts 30 comprise a plastic or
polymer material, with a diameter between 0.5
mm and 5 mm and particularly about 2 mm.
It is contemplated that the shaft 32 may be formed in any of a variety of
elongated shapes in addition to the
cylindrical shape shown in the illustrated embodiments, such as square,
triangular and the like to suit a particular
application. As described in greater detail below, the elongated shape of the
shaft 32 preferably generally matches the
shape of the holes 74 in the catheter fitting 14.
The shaft 32 has a securing portion which inhibits migration of the catheter
12 and catheter fitting 14. The
securing portion may comprise one or more elements described below.
One element that the securing portion may comprise includes a protrusion that
extends radially from the shaft
32. As shown in Figures 2a, 3a and 4a, the protrusion comprises an enlarged
tip or head 34 at the end distal from the base
22. At least a portion of the circumference of the head 34 is larger than the
circumference of the shaft 32, desirably
having a maximum circumference of 1.1 to 3 times the circumference of the
shaft 32. Figure 2a shows the head 34 having
a generally hemispherical shape with a smooth surface and a maximLffn
circumference at an overhanging lower surface or
underside 36. It will be understood, however, that the head 34 can take a
variety of other shapes, with or without an
underside 36, such as for example, solid or hollow conicals, arrowheads,
barbs, spheres, mushroom heads, and other types
of radially projecting structures. A relatively blunt end 37 of the head 34 is
preferred to avoid snagging on materials such
as a health care providers latex gloves or sheets on the patient's bed.
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As seen in Figures 2a, 3a and 4a, the underside 36 is generally planar.
However, the underside 36 may be curved
to form a recess 38 in which a portion of the catheter fitting 14 may be
retained. The underside 36 may also have a
surface which is roughened or which incorporates ridges or other snagging
devices (not shown) to further assist in retaining
the catheter fitting 14. However, the underside 36 may also be smooth, for
less expensive fabrication costs.
Another element that the securing portion may comprise includes a hook 40. As
shown in Figures 2b, 3b and 4b,
the hook 40 has a radial portion 42 which extends outwardly from the shaft 32.
Advantageously, the hook 40 has a curved
portion 44 distal the shaft 32 and positioned toward a distal end of the
radial portion 44. The curved portion 42 is sized
and configured to accept a hole in the catheter fitting. Desirably, the curved
portion 42 has a chamfer or taper 46 along the
distal circumference to a8ow a medical attendant to easily fit the holes 74 in
the catheter fitting 14 around the hook 40.
With reference now to Figures 1, 2a and 3a in general, the chp 48 is formed on
the base 22. The illustrated
embodiments show one clip 48 extending from the base 22. However, the base 22
can also include additional clips to suit a
specific application, as noted above. For example, where the retainer 20 is
designated to secure a relatively large catheter,
the base can include two ciips arranged on opposing ends of the catheter, for
greater stability. Also, three clips can be used
to firmly anchor a Y-site catheter.
The clip 48 is sized and shaped to readily accept a portion of the catheter 12
while not easily disengaging the
accepted portion of the catheter 12. Advantageously, the clip 48 inhibits
transverse movement of at least a portion of the
catheter 12. Transverse movement of the catheter 12 is inhibited by contact
with the clip 48, which is of sufficiently rigid
construction and secured to the base 22 to act as a stop against advancement
of the catheter 12 in the transverse
direction. Inhibition of transverse movement of the catheter is advantageous
because this movement can translate into
movement of the catheter 12 at the engagement site between the catheter 12 (or
catheter fitting 14) and post 30. This
movement, in tum, can cause the catheter fitting 14 to roil or slip off the
posts 30 and slide from engagement with the
posts 30.
The clip 48 can be configured in a variety of ways to achieve its purpose.
Figure 2a illustrates a substantially C=
shaped clip within which a portion of the catheter 12 is captured. Figure 2c
illustrates a pair of a semi-rigid, inverted L-
shaped members that are closely spaced apart to releasably accept a catheter
12 that is sized greater than the spacing
between the L=shaped members. As will be understood by one skilled in the art,
a variety of other clip configurations, such
as a single L-shaped clip, can be used to achieve the purpose of the clip.
The clip 48 may also include a hook portion 52 as described above, or a
variety of other snagging, hooking and
inhibiting devices as described above. The clip 48 can have a variety of sizes
depending upon the particular application and
the particular catheter 12 with which it is used.
In the illustrated embodiment, the clip 48 is arranged along a longitudinally
extending line that substantially
bisects a laterally extending line that extends between the two posts 30. An
area 54 is formed on the retainer between the
first and second sides and desirably laterally between the posts 30. The area
54 is sized and shaped so as to accept and
retain a portion of a catheter 12 in a close fit manner between the posts 30
and the clip 48.
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Figure 1 illustrates an anchor pad 56 which desirably comprises a laminate
structure with an upper foam layer
(e.g., closed-cell polyethylene foam), and a lower adhesive layer. The lower
adhesive layer constitutes the lower surface 58
of the anchor pad 56. The lower surface 58 desirably is a medical=grade
adhesive and can be either diaphoretic or
nondiaphoretic, depending upon the particular application. Such foam with an
adhesive layer is available commercially from
New Dimensions in Medicine of Columbus, Ohio. The illustrated embodiment shows
the anchor pad 56 having suture
holes 60 in addition to the adhesive layer to further secure the anchor pad 56
to the patient's skin. It will be understood,
however, that the anchor pad 56 need not include suture holes 60 to secure the
anchor pad 56 to the patient's skin.
A surface of the upper foam layer constitutes an upper surface 62 of the
anchor pad 56. The upper surface 62
desirably is roughened by corona=treating the foam with a low electric charge.
The roughened or porous upper surface 62
improves the quality of the adhesive joint (which is described below) between
the base 22 and the anchor pad 56. In the
alternative, the flexible anchor pad 56 can comprise a medical-grade adhesive
lower layer, an inner foam layer and an upper
paper or other woven or nonwoven cloth layer.
In the illustrated embodiment, the anchor pad 56 also desirably includes a
pair of opposing crescent sections 64,
66 with a recess toward the proximal end 24 of the anchor pad 56 proximate to
the clip 48. As a result, the lateral sides of
the anchor pad 56 have more contact area which provides greater stability and
adhesion to a patient's skin.
Figure 5 shows a removable paper or plastic release liner 68 which desirably
covers the adhesive lower surface
58 before use. The liner 68 preferably resists tearing and desirably is
divided into a plurality of pieces to ease attachment
of the pad to a patient's skin. In the illustrated embodiment, the iiner 68 is
split along a center line 70 of the flexible anchor
pad 56 in order to expose only half of the adhesive lower surface 58 at one
time.
The liner 68 length extends beyond the center line 70 of the anchor pad 56 and
is folded over, or back onto the
liner 68. This folded over portion defines a pull tab 71 to faciGtate removal
of the liner 68 from the adhesive lower surface
58. A medical attendant uses the pull tab 71 by grasping and pulling on it so
that the liner 68 is separated from the lower
surface 58. The puU tab 71 overcomes any requirement that the medical
attendant pick at a corner edge or other segment
of the liner 68 in order to separate the liner 68 from the adhesive layer. The
pull tab 71 of course can be designed in a
variety of configurations. For example, the pull tab 71 need not be located
along the center line 70 of the anchor pad 56;
rather, the pull tab 71 may be located along any line or portion of the anchor
pad 56 in order to ease the application of the
anchor pad 56 onto the patient's skin at a specific site. For example, an area
of a patient's skin with an abrupt bend, such
as at a joint, may require that the pull tab 71 be aligned toward one of the
lateral ends of the anchor pad 56 rather than
along the center line 70.
The base 22 of the retainer 20 is attached to the upper surface 62 of the
anchor pad 56. The base 22 desirably
is secured to the upper surface 62 by a solvent bond adhesive, such as
cyanoacrylate or other bonding material. One such
adhesive is available commercially as Part No. 4693 from the Minnesota Mining
and Manufacturing Company (3M).
When the anchoring system 10 is assembled as described above, the area 54
formed on the base 22 defines a
receiving space 72. The receiving space 72 is capable of accepting a portion
or length of the catheter 12. Although the
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receiving space 72 may take the form of various shapes depending upon its
application (i.e., depending upon a shape of the
retained portion of the medical article for which the retainer 20 is designed
to be used), the receiving space 72 does have a
sufficient length in the longitudinal direction to stabilize the catheter 12,
rather than act as a fulcrum for the catheter 12,
as mentioned above. That is, the longitudinal spacing between the posts 30 and
the clip 48 on the retainer 20 is sized so as
to receive sufficient length of the catheter 12 to inhibit movement of the
catheter 12 in the lateral, longitudinal and
transverse direction (i.e., to inhibit yaw, pitch and axial movement of the
catheter 12), without kinking the catheter 12.
When the catheter fitting 14 is placed onto the posts 30 via the holes 74 and
pressed onto the receiving space
72, a section of the catheter 12 is captured within the retainer 20.
Desirably, the catheter fitting 14 is constructed of
material that is more elastic than the retainer 20 and the distance between
the posts 30 is sfightly larger than the distance
between the holes 74 in the catheter fitting 14. By this design, when the
catheter fitting 14 is stretched to allow the posts
30 to accept the catheter fitting holes 74, a tensile force is applied to the
catheter fitting 14 and a tight-fit relationship
between the posts 30 and catheter fitting 14 exists to inhibit axial and
rotational movement of the catheter 12. Rotational
movement of the catheter 12 is further inhibited by the clip 30, as described
above.
In operation and as itlustrated in Figures 6-8, a medical attendant may secure
a catheter 12 (or other medical
article) to a patient using the above-described anchoring system (or a readily
apparent modification thereof). The medical
attendant first transversely aligns the holes 74 in the catheter fitting 14
over the posts 30. The catheter 12 may then be
placed into the receiving space 72 formed between the lateral sides of the
base 22 by engaging the holes 74 in the
catheter fitting 14 around the post 30. This is done by first inserting a
first post into one of the suture holes 74, as seen in
Figure 7, and then stretching the fitting 14 so as to align the other suture
hole 74 over the second post 30. The fitting 14
is then slipped over the second post 30 by inserting the post 30 into the hole
74. In doing so, the catheter fitting 14 is
hooked under the lower surface 36 of the post 30. The interaction between the
under surface 36 of the posts 30 and the
portions of the catheter fitting 14 about the suture holes 74 inhibits the
catheter fitting from pulling off the posts 30 in a
transverse direction. And the general interaction between the posts 30 and the
fitting 14 inhibits significant (i.e.,
meaningfui) longitudinal and lateral movement of the catheter 12 relative to
the retainer 20.
As seen in Figure 8, a distal section of the catheter 12 is inserted into the
clamp 48 by positioning the catheter
12 next to an opening in the cGp 48 and pulGng the catheter 12 into the cGp.
The deformable nature of the catheter 12,
andlor the deflectable nature of the clip 48 permits the catheter section to
be inserted into a space between at least a
section of the clip 48 and the base 22. Importantly, a portion of the clip 48
extends generally parallel to the base 22 and
generally normal to the posts 30. This section of the clip 48 prevents the
distal portion of the catheter 12, which is
unsecured behind clip 48, from applying a transverse force on the catheter
fitting 14 when pulled transversely away from
the retainer. As a result of this design, greater transverse force can be
applied to the catheter before it disengages from the
retainer, in comparison to a design that does not include a clip 48.
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If the catheter 12 is pulled in an axial or rotational direction, interaction
between the posts 30, clip 48 and
catheter fitting 14 also prevents the catheter 12 from appreciable movement.
The retainer 20 thus inhibits axial or
rotational movement of the catheter 12 relative to the retainer 20.
Importantly, the posts 30 and clip 48 do not crimp or kink the catheter 12
body when it is inserted within the
receiving space 72. Moreover, although the post 30 and clip 48 bear against
the catheter, their limited pressure does not
significantly occlude the corresponding catheter 12 lumen(s). Although Figure
8 illustrates a space between the securing
portions 34 of the posts 30 and the catheter fitting 14, the shafts 32 of the
posts 30 can be sized for a particular catheter
fitting 14 so as to reduce the amount of transverse play of the catheter
fitting within the anchoring system when secured.
Figures 9 and 10 illustrate an anchoring system configured in accordance with
another embodiment of the
present invention. Like the anchoring system of the previous embodiment, this
anchoring system includes a retainer with at
least one retention member and an anchor pad. However, the particular
configuration of these elements differs slightly.
Also, the particular configuration of the medical article that connects to the
anchoring system differs. Thus, for
consistency, like numbers with an "a" suffix have been used to indicate like
parts of the anchoring system of Figures 1=8.
The above description of the like components thus should be understood as
applying equally to the present embodiment of
the anchoring system 10a, unless otherwise stated.
With reference to Figure 9, the illustrated catheter fitting 14a is
constructed entirely from a silicon material for
pliability purposes, which allows the pair holes 74a in the laterally
extending wing portion 13a of the fitting 14a to be
enlarged during connection or disconnection operations. The catheter fitting
14a also has an elongate body with an inner
lumen that houses the catheter 1 2a and can be attached to a plastic
connecting piece 10. The exemplary midline catheter
12a is avalable commercially from Becton, Dickinson and Company of Sandy, Utah
as First Mid-CathTM.
Like the previous embodiment, the retainer 20a is constructed, sized and
configured to receive a portion of the
catheter fitting 14a and to provide space on which to locate at least one
retention member.
With reference to Figure 10, the first retention member desirably comprises
two laterally spaced posts 30a,
ahhough one, three or more posts can be used. Each post 30a includes a shank
or shaft 32a attached to and extending
generally upright from the base 22a. Each shaft 32a has a length of about 2 mm
to 20 mm and desirably about 4 mm, and
is laterally spaced apart a distance of 5 mm to 40 mm from the other shaft
32a, and desirably about 20 mm. The shaft
32a of each post 30a has a diameter sufficient to perform its structural
function, with the illustrated shafts 32a having a
diameter between 0.5 mm and 5 mm and desirably about 2 mm.
The shaft 32a may include a securing portion to inhibit migration of the
catheter 12a and catheter fitting 14a
relative to the shaft 32a. If used, the securing portion may comprise one or
more elements previously described or
described below. Alternatively, the shaft 32a may forgo use of a securing
portion to assist in connecting or disconnecting operations, as explained
below.
One element that the securing portion may comprise is a protrusion that
extends radially outwardly from the end
of the shaft 32a distal the base 22a. As best shown in Figure 10A, the
protrusion comprises a generally smooth angular
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enlarged tip or head 34a with an underside 36a that radiaAy extends around the
entire diameter of the shaft 32a. It will be
understood, however, that the head 34a can take a variety of other shapes,
with or without an underside 36a or portion
thereof, such as for example, solid or hollow conicals, arrowheads, barbs,
spheres, mushroom heads, hemispheres and
other types of radially projecting structures. A relatively blunt end 37a of
the head 34a is preferred to avoid snagging on
materials such as a health care provider's latex gloves or sheets on the
patient's bed. Altematively, a relatively rounded end
100 of the head 34a is preferred to assist in fitting the holes 74a over the
head 34a. At least one of the heads 34a may
optionally include an angled extended portion 102 that faces away ftom the
other post 30a. The angled portion 102 is
sized and configured to accept the hole 74a of the catheter fitting 14a and
desirably has a chamfer or taper 46a along the
outer end to more easily fit the hole 74a of the catheter fitting 14a around
the angled portion 102. Once the hole 74a is
fitted around the angled portion 102, the hole 74a can be advancedlstretched
around the head 34a and then onto the shaft
32a.
Another element that the securing portion may comprise is also a protrusion
that extends radially outwardly from
the end of the shaft 32a distal the base 22a. As shown in Figure 10B, the
protrusion comprises a generally smooth rounded
enlarged tip or bulb 104 not having an underside. However, an underside that
radially extends around the entire length of
the shaft 32a or a portion thereof could be used. A relatively blunt end 106
of the bulb 104 is preferred to avoid snagging
on materials such as a health care provider's latex gloves or sheets on the
patient's bed. Altematively, a relatively rounded
end 108 of the bulb 104 is preferred to assist in fitting the holes 74a around
the bulb 104. The bulb 104 may optionally
include a curved extended portion 110 that faces away from the other post 30a.
The curved portion 110 is sized and
configured to accept the hole 74a in the catheter fitting 14a and desirably
has a chamfer or taper 46a along the free end to
more easily fit the hole 74a in the catheter fitting 14a around the curved
portion 110. Once the hole 74a is fitted around
the curved portion 110, the hole 74a can be advanced around the bulb 104 and
then onto the shaft 32a.
As noted above, both shafts 32a need not include a securing portion. If a
securing portion is not used, the end of
the shaft 32a distal the base 22a desirably has a smooth slightly rounded
surface. This configuration assists in fitting the
holes 74a in the catheter fitting 14a onto the shaft 32a. This configuration
(not shown) provides for more easy
engagement of the hole 74a with the shaft 32a fi.e. the hole 74a is not
required to further enlarge to fit over the head 34a
or bulb 104); however, the use of the securing portion 34a on both shafts 32a
increases the security of the catheter fitting
14a on the retainer 20a.
With reference again to Figure 10, the second securing member comprises a clip
48a that extends from the base
22a. Like the previous embodiment, the clip 48a is sized and shaped to readily
accept a portion of the catheter fitting 14a
or a section of the catheter 12a while not easily disengaging the accepted
portion of the catheter fitting 14a or catheter
12a. Advantageously, the clip 48a also inhibits transverse movement of at
least a portion of the catheter fitting 14a.
The clip 48a can be configured in a variety of ways to achieve its purpose.
For example, Figure 10A shows the
clip 48a being generapy C shaped and configured generally similar to the clip
of Figure 2A. However, the present
embodiment of the cGp 48a has a larger, more defined hook portion 52a that
extends toward the base 22a to narrow or
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partially occlude the entranceway 112 into the clip interior 114. The narrowed
entranceway 112 requires the medical
attendant to flatten or otherwise contort a portion of the catheter fitting
14a when passing it through the entranceway
112 and into the clip interior 114. Once a portion of the catheter fitting 14a
is positioned within the clip interior 114, the
narrowed entranceway 112 requires that a portion of the catheter fitting 14a
be flattened or otherwise contorted to
dislodge the catheter fitting 14a from the clip interior 114. This arrangement
inhibits accidental dislodgment of the
catheter fitting 14a from the clip interior 114. In particular, the
illustrated narrowed entranceway 112 has a transverse
height that is less than three quarters of the transverse height of the
catheter fitting 14a and desirably less than '/: the
transverse height of the catheter 12a and more desirably about one-half of the
transverse height of the catheter fitting
14a. Stated alternatively, for use in connection with the illustrated catheter
fitting 14a, the narrowed entranceway 112
has a transverse height of about 1 mm to 5 mm and desirably about 3 mm.
For another example, Figure 10B shows the clip 48a being a generally inversely
L-shaped and configured
generally similar to the clip of Figure 2B. However, the present embodiment of
the clip 48a does not include any hook
portion at all. Thus, the entranceway 112 to the clip interior 114 is not
narrowed or partially occluded, which facilitates
insertion or removal of the catheter fitting 14a into the clip interior 114.
In particular, the clip 48a has a transverse height
than is the same or slightly greater than the transverse height of the
catheter fitting 14a, or, for use with the illustrated
catheter fitting 14a, about 3 to 10 mm and desirably about 6 mm.
Figure 9 illustrates an anchor pad 56a including a laminate structure with an
upper foam layer 62a, a lower
adhesive layer 58a and suture holes 60a formed through the layers 58a, 62a
that is constructed similar to the anchor pad
of Figure 1. Ahhough the particular configuration of the anchor pad 56a is
generally similar to the anchor pad of Figure 1
(i.e. includes a pair of opposing crescent sections 64a, 66a with a recess
area 116 toward the clip 48a end of the pad
56a), the particular configuration of the anchor pad 56a has a less severe
pair of opposing crescent sections 64a, 66a and
a less defined recess area 116. This configuration provides sufficient contact
area for greater stability and adhesion to a
patient's skin. Also, the anchor pad 56a is not sized and configured generally
similar to the size and shape of the release
liner 68a. That is, the release liner 68a covers the adhesive lower surface
58a of the anchor pad 56a as well as the recess
area 116.
Figure 10A illustrates a particularly advantageous embodiment of the anchoring
system 10a. The anchoring
system 10a utilizes a first retention member that comprises a pair of posts
30a wherein one post has a securing portion
including a head 34a with a relatively blunt end 37a and a tapered angled
extended portion 102, and the other post has a
securing portion including a head 34a with a relatively rounded end 100 and no
angled extended portion. This combination
allows the medical attendant to easily connect the catheter fitting 14a to the
retainer 20a by first fitting a hole 74a in the
catheter fitting 14a through the angled extended portion 102 of the post 30a,
then over the head 34a, and then onto the
shaft 32a. The other hole 74a in the catheter fitting 14a can then be fit onto
the other post 30a {which does not have the
angled extended portion 102). The other hole 74a can be more easily fit onto
the other shaft 32a via the rounded end 100
than if the other shaft 32a included a blunt end 37a or further included an
angled extended portion 102 that faced away
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from the secured hole 74a. Thus, by this synergistic configuration, the holes
74a are easily fit onto both posts 30a and
both posts 30a have a securing portion to inhibit catheter migration. The
illustrated anchoring system also includes a
second retention member embodied as a clip 48a with a hook portion 52a that
transversely narrows the entranceway 112
to the clip interior 114 to about'h the transverse height of the catheter 12a.
Figure 108 illustrates another particularly advantageous embodiment of the
anchoring system 10a that uses the
combination of a first retention member comprising a pair of posts 30a wherein
one post has a securing portion including a
bulb 104 with a relatively blunt end 106 and an curved extended portion 110,
and the other post 30a has a securing
portion induding a bulb 104 with a relatively rounded end 108 and no curved
extended portion. Like the embodiment of
Figure 10A, this combination allows the medical attendant to easily connect
the catheter 12a to the retainer 20a by first
fitting a hole 74a in the catheter fitting 14a through the curved extended
portion 110, then over the bulb 104, and then
onto the shaft 32a. The other hole 74a in the catheter fitting 14a can then be
fit onto the other post 30a (which does not
have a curved extended portion 110). The other hole 74a can be more easily fit
onto the other shaft 32a via the rounded
end 108 than if the other shaft 32a included a blunt end 106 or further
included a curved extended portion 110 that faced
away from the secured hole 74a. Thus, by this synergistic configuration, the
holes 74a are easily fit onto both posts 30a
and both posts 30a have a securing portion to inhibit catheter migration. The
illustrated anchoring system 10a also
includes a second retention member embodied as a clip 48a without a hook
portion 52a so that the transverse height of the
entranceway 112 is not narrowed toward the clip interior 114.
The present anchoring system thus provides a sterile, tight-gripping, needle
and tape-free way to anchor a
catheter to a patient. The retainer 20 thus eliminates use of tape, and 'rf
prior protocol required suturing, it also eliminates
accidental needle sticks, suture-wound-site infections and scarring. In
addition, the retainer 20 can be configured to be
used with any of a wide variety of catheters 12, fittings 14, tubes, wires,
and other medical articles. Patient comfort is
also enhanced and appGcation time is decreased with the use of the present
anchoring system.
Although this invention has been described in terms of certain preferred
embodiments and suggested possible
modifications thereto, other embod-unents and modifications 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 or
several embodiments can be used with another
or several embodiments. It is further understood that not all of the aspects
or elements described in connection with a
particular embodiment need to be utilized in connection with that or another
embod'unent. Accordingly, the scope of the
invention is intended to be defined only by the claims which follow.
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