Medical tubing securement system

A securing system includes a simply-structured device which permits medical tubing or other elongated medical devices to be easily secured to a patient, desirably without the use of tape or needles and suturing. The securing system includes a fitting having one or more flexible arms which secure the medical tubing to the fitting. The securing system may also include a retainer having a flexible anchor pad with an adhesive bottom surface, which can be attached to the patient's skin. The fitting can be mounted to the retainer, for example, by inserting posts of the retainer through holes of the fitting. Advantageously, the securing system can be attached anywhere along the length of the tubing and can be applied to tubing of any size. Further, the system is simply to instal and easy to apply.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The present invention relates to a system for securing medical tubing to a 
patient. 
2. Description of Related Art 
It is very common in the medical industry to utilize medical tubing to 
provide various liquids or solutions to a patient. For example, medical 
tubing such as an intravenous ("IV") catheter is often used to introduce 
fluids and medications directly into the bloodstream of a patient. In many 
cases, and particularly with respect to cardiac therapy, the IV catheter 
is introduced into a central or larger vein located close to the patient's 
heart. A typical catheter utilized in connection with a central vein is 
referred to as a "central venous catheter" ("CVC"). A venous catheter 
peripherally inserted into the central circulation through a vein in the 
arm is commonly referred to as a "peripherally inserted central catheter" 
("PICC"). 
In these cases, long-term IV infusion typically requires that the catheter 
remain in place for many days. In order to secure such an IV catheter in 
position at the insertion site, the catheter often is provided with an 
integrated or a movable flexible clamp with winged extensions which are 
sutured to the patient's skin. In other applications, the flexible clamp 
is covered by a rigid box clamp, which receives the catheter/clamp 
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 the box clamp securely attaches the catheter to the patient, the 
sutures are obviously painful and uncomfortable for the patient. 
Additionally, the rigid box clamp is relatively expensive and its use is 
limited to a catheter of a particular size. Thus, a plurality of box 
clamps of different sizes must be available for use with catheters of 
different sizes. Further, box clamps require a significant amount of time 
and effort to instal, increase the risk of needle-stick to the health care 
provider, and are difficult to use. 
SUMMARY OF THE INVENTION 
A need therefore exists for a simply-structured securement system that 
attaches medical tubing in a generally fixed position to a patient. 
The present invention advantageously provides a securing system that is 
simple and easy to apply. Significantly, the securing system can be 
connected anywhere along the length of the tubing and it can be connected 
to tubing of any size. In addition, the present securing system is 
inexpensive and does not require any significant labor or effort to 
install. These and other advantageous are set forth in greater detail 
below. 
One aspect of the present invention involves a securing system for 
attaching medical tubing to a patient. The securing system includes a 
fitting having at least one flexible arm adapted to engage medical tubing. 
The flexible arm includes at least two sides and at least a portion of one 
side includes an adhesive layer. The fitting also includes a coupling 
structure which allows the fitting to be connected to a patient. 
Another aspect of the present invention includes a securing system with a 
fitting having at least one arm configured to engage the medical tubing, 
and a coupling structure to attach the medical tubing to the patient. The 
securing system preferably also includes retainer with a base configured 
to be attached to a patient. The coupling structure allows the fitting to 
be mounted to the retainer. 
Yet another aspect of the present invention involves a securing system for 
attaching medical tubing to a patient. The securing system comprises a 
retainer including a base for receiving a fitting. Desirably a cover is 
coupled to the base. The cover is movable between a closed position, in 
which at least a portion of the cover extends over at least a portion of 
the base, and an open position. Preferably a latching mechanism operates 
between the base and the cover to releasably latch the cover to the base 
with the cover in the closed position. The securing system desirably also 
includes a fitting having at least one arm with an adhesive on one 
surface. The fitting and retainer also include a coupling structure which 
allows the fitting and retainer to be connected. 
A further aspect of the present invention involves a securing system for 
attaching medical tubing to a patient. The securing system includes a 
fitting with at least one arm and a coupling structure. The securing 
system also includes a retainer with a base, and at least one filament 
extending from the base. At least one receptacle is coupled to the base 
and the receptacle is arranged so as to cooperate with at least one of the 
filaments. Each receptacle includes at least one aperture which is 
configured to receive the filament. The aperture inhibits retraction of 
the filament from the receptacle. The coupling structure allows the 
fitting to be mounted to the retainer. 
A preferred method of attaching medical tubing to a patient involves 
providing a retainer including a base with at least one post extending 
from the base. The retainer also includes an adhesive layer to secure the 
retainer to the patient. The retainer is positioned on the patient, and 
the adhesive layer is attached to the patient. A fitting including at 
least one flexible arm and at least one aperture configured to engage the 
post is also provided. The fitting is positioned over the base to bring 
the aperture of the fitting in proximity with the post of the base. The 
fitting is mounted to the base by engaging the post with the aperture in 
the fitting. 
Further aspects, features, and advantages of the present invention will 
become apparent from the detailed description of the preferred embodiments 
that follow.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
The present embodiments of the medical tubing securing system are disclosed 
in the context of an exemplary central line catheter. The principles of 
the present invention, however, are not limited to PICCs or CVCs. Instead, 
it will be understood by one of skill in this art, in light of the present 
disclosure, that the securing systems disclosed herein can be successfully 
utilized in connection with other types of medical tubing or lines, 
including tubes for fluid communication, electrical wires and the like. 
For example, but without limitation, the systems disclosed herein can 
retain CVCs, PICCs, Foley catheters, and hemodialysis catheters; surgical 
drainage tubes, feeding tubes, chest tubes, and nasogastric tubes; scopes; 
and electrical wires or cables connected to external or implanted 
electronic devices or sensors. One skilled in the art may also find 
additional applications for the devices and systems disclosed herein. 
Thus, the illustration and description of the securing system in 
connection with a catheter is mainly exemplary of one possible application 
of the system. 
Each of the preferred embodiments described herein employ the same basic 
concepts and characteristics of the medical tubing securing system, namely 
using a fitting to attach medical tubing to a patient. The fitting 
includes a coupling structure that allows the fitting to be mounted 
directly to the patient (i.e., sutured to the patient), or to a connector 
such as a retainer. The connection of the fitting and the retainer may be 
readily releasable for quick disconnection, or the connection may provide 
a secure, relatively permanent connection. Preferably, the connection of 
the retainer and the fitting generally inhibits relative movement between 
the medical tubing and the retainer in at least one degree of freedom. 
To assist in the description of the components of the disclosed securing 
systems, the following coordinate terms are used. A longitudinal axis 
extends generally parallel to the elongated portion of the retainer, 
generally in the plane of a base of a retainer (discussed below). A 
lateral axis extends generally perpendicular to the longitudinal axis 
within the plane of the base of the retainer. A transverse axis extends 
generally transverse to both the longitudinal and lateral axes. In 
addition, as used herein, "longitudinal direction" refers to a direction 
substantially parallel to the longitudinal axis; "lateral direction" 
refers to a direction substantially parallel to the lateral axis; and 
"transverse direction" refers to a direction substantially parallel to the 
transverse axis. These coordinates are used to describe the structure and 
positioning of the securing system. A detailed description of the 
preferred embodiments now follows. 
FIG. 1 illustrates a securing system 10 constructed in accordance with a 
preferred embodiment of the present invention. The system 10 includes 
fitting 14 which is configured to retain medical tubing. It will be 
understood by one skilled in the art that the medical tubing is used 
broadly to include a variety of types of medical tubing or lines. For 
example, without limitation, the medical tubing may include lines, 
passages, conduits, catheters, wires, cables and the like. 
The fitting 14 desirably allows the medical tubing to be placed in the 
proper position relative to the patient. Advantageously, as described 
below, the fitting 14 may be configured to engage different types of 
tubing in a variety of configurations, and the fitting may be connected to 
any portion of and at any location along the tubing. Additionally, the 
fitting 14 may be attached directly to the skin of the patient, or to a 
retainer which is attached to a patient. The fitting 14 may be connected 
directly to the patient, for example by using sutures or medical grade 
adhesive tape. As described below, various types of retainers can also be 
used in conjunction with the fitting 14 to attach the medical tubing to 
the patient. 
In a preferred embodiment, the fitting 14 is configured to be attached to a 
retainer 12 with a base 16. The base 16 of the retainer 12 is attached to 
an anchor pad 18. The base 16 desirably is secured to the anchor pad 18 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"). 
The anchor pad 18 comprises a flexible structural layer for securing the 
retainer 12 to a patient's skin. The pad desirably comprises a laminate 
structure with an upper cellulose foam layer (e.g., closed-cell 
polyethylene foam), and a bottom adhesive layer. The adhesive 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. Although not illustrated, it will be understood that the 
retainer and/or anchor pad can include suture holes in addition to the 
adhesive layer to further secure the anchor pad to the patient's skin. 
An upper surface of the foam layer is roughened by corona-treating the foam 
with a low electric charge. The roughened or porous upper surface of the 
anchor pad 18 improves the quality of the adhesive joint formed by the 
cyanoacrylate (or by another type of adhesive or bonding material) between 
the base 16 and the anchor pad 18. Alternatively, the anchor pad 18 can 
comprise a medical-grade adhesive bottom layer, an inner cellulose foam 
layer and an upper paper or other woven or nonwoven cloth layer. 
A removable paper or plastic backing 20 desirably covers the bottom 
adhesive surface of the anchor pad 18 before use. The backing 20 
preferably resists tearing and is divided into a plurality of pieces to 
ease attachment of the pad to a patient's skin. Desirably, the backing 20 
is split along a center line 22 of the anchor pad 18 in order to expose 
only half of the adhesive bottom surface at one time. The backing 20 also 
advantageously extends beyond at least one edge of the anchor pad 18, as 
illustrated in FIG. 1, to facilitate removal of the backing 20 from the 
adhesive layer. Although not illustrated, the halves of the backing 20 can 
be formed with excess material folded downward at the center line 22 to 
form pull tabs. These tabs further facilitate removal of the backing and 
application of the anchor pad 18 to the patient. 
In the illustrated embodiment, the anchor pad 18 also desirably includes a 
pair of opposing enlarged sections surrounding the relatively narrower 
center section of the anchor pad 18. As a result, the peripheral ends of 
the anchor pad 18 have more contact area to provide greater stability and 
adhesion to a patient's skin, while allowing the center section of the 
anchor pad 18, proximate the base 16, to cover a relatively smaller 
portion of the patient's skin. 
The retainer 12 and the fitting 14 desirably include interacting coupling 
structure to couple the fitting 14 to the retainer 12. As will be clear 
from the disclosure below, the interacting coupling structure that mounts 
the fitting 14 to the retainer 12 may comprise a variety of structures. 
The term "mount," when used with reference to the relation between the 
fitting 14 and the retainer 12, does not necessarily imply that the 
medical tubing is immobilized or fixed. Rather, this term is meant to 
describe the condition in which the movement of the medical tubing 
relative to the retainer 12 is constrained in at least one degree of 
freedom (e.g., rotational, lateral, longitudinal or transverse). 
As seen in FIG. 1, a portion of the interacting coupling structure on the 
base 16 comprises at least one post 24 which extends generally upwardly 
from a relatively rigid platform 26. The base 16 desirably includes two 
posts 24a and 24b. The base 16 can also include additional posts to suit a 
specific application. For example, where the retainer is designed to 
secure a relatively large fitting, the base can include four posts 
arranged at the corners of a rectangle, for greater stability. 
Alternatively, three posts can be used to firmly anchor a Y-site fitting. 
One skilled in the art will recognize the number of posts may depend upon 
the desired use of the securing system 10. 
Each post 24 includes a shank or shaft 28 which is attached to and extends 
generally upwardly from the platform 26. The posts 24 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 medical tubing. Preferably, each post 24 
desirably has a length of about 0.1 cm to 1 cm, and more preferably a 
length of about 0.6 mm; however, longer or shorter lengths also are 
possible. The posts 24 are laterally spaced at least wide enough to engage 
the fitting 14. Preferably, the posts 24 are spaced apart by a distance 
between 0.2 cm and 2 cm, and more preferably by a distance equal to about 
1.2 cm. The shaft 28 of each post 24 has a diameter sufficient to perform 
its structural function, as described in more detail below, and depends 
upon the material chosen for the base 16 and shafts 28. The illustrated 
posts 24 preferably comprise a polymer plastic material, with a diameter 
between 0.5 mm and 20 mm and particularly about 10 mm. 
At least one protrusion 30 extends radially outward from the shaft 28 of 
each post 24. As seen in FIG. 1, the protrusion 30 preferably comprises an 
enlarged tip or head at the end distal from the platform 26. Desirably, 
the protrusion 30 has a diameter of 1.1 to 1.5 times the diameter of the 
shaft 28. In the illustrated embodiment, the protrusion 30 has a generally 
hemispherical shape with a generally smooth upper surface. It will be 
understood that the protrusion 30 can take a variety of other shapes, such 
as, for example, solid or hollow conicals, arrowheads, barbs, spheres, 
mushroom heads, and other types of radially projecting structures. A 
relatively blunt end of the protrusion 30 is preferred to avoid snagging 
on materials such as a health care provider's latex gloves or sheets on 
the patient's bed. 
FIGS. 1 and 2 illustrate the fitting 14 with two flexible arms 32a and 32b. 
Alternatively, as discussed below in conjunction with FIGS. 10 and 11, the 
fitting may have only a single flexible arm. Of course more than two arms 
may also be utilized, for example, depending upon the desired use of the 
fitting or the type of medical tubing to be attached to the fitting. The 
arms 32 are preferably between 2 cm and 20 cm in length and, more 
preferably, about 6 cm in length. Of course, any length sufficient to 
engage the medical tubing may be utilized. 
The arms 32 are preferably constructed from a flexible material such as 
plastic, cloth, or paper that exhibits sufficient strength to withstand 
tearing or significant deformation in the context of the intended use of 
the fitting 14. More preferably the arms are constructed from a spun 
bonded olefin, paper-like material available from E.I. DuPont de Nemours, 
Inc. under the trade name 1079D Tyvek.TM., but other materials such as 
polyethylenes may also be suitable. The Tyvek.TM. preferably has a 
thickness of about 0.008 inch. 
At least a portion of one side of the arms 32 includes an adhesive layer 36 
(shown in FIG. 3). The adhesive is desirably a medical-grade adhesive such 
as Part No. 9672LE by 3M. The adhesive layer 36 preferably has a thickness 
of about 0.005 inch, but the thickness can also be greater or smaller. The 
arms 32a and 32b are desirably arranged at approximately a 90.degree. 
angle relative to each other, but it will be understood that the arms can 
be arranged at any desired angle, depending, for example, on the number of 
arms and the type of medical tubing to be attached to the fitting. 
As best seen in FIGS. 2 and 3, a removable backing paper 40 (i.e., a 
release layer) desirably covers the adhesive layer 36 before use. The 
backing 34 preferably resists tearing and is divided into separate 
portions to ease attachment of the fitting 14 to the medical tubing. 
Desirably, the backing 40 is cut along lines 38a, 38b, 38c to form four 
different portions 40a, 40b, 40c, 40d to facilitate attachment of the 
medical tubing to the fitting 14. 
The fitting 14 also includes a coupling structure 42, which preferably 
comprises a base 44 attached to the flexible arms 32. The base 44 is 
generally rectangular in configuration and is preferably constructed from 
a material which is more rigid than the flexible arms 32. The base 44 is 
preferably located proximate the intersection of the arms 32a and 32b, as 
shown in the accompanying figures, but the base may be connected to any 
portion of the arms 32. The arms 32 are preferably located at about a 
45.degree. angle relative to the base 44, but the arms can be attached at 
any angle relative to the base 44. The base 44 includes at least one 
aperture 46, and preferably two apertures 46a and 46b, but more than two 
apertures may also be utilized. The base 44 is preferably constructed from 
polyvinylchloride ("PVC") and the base 44 has a thickness of about 0.008 
inch, but other materials and different thickness, depending for example 
upon the desired use of the fitting 14, may also be used. Alternatively, 
instead of using a base, the coupling structure 42 may simply comprise one 
or more apertures located in the arms 32 of the fitting 14. 
The fittings 14 are preferably constructed using a converter process. As 
known in the art, a converter process may use large rolls or sheets of 
material to construct a laminate structure. For example, the converter 
process is first used to apply the adhesive layer 36 to the roll or sheet 
of material used to construct the flexible arm 32, preferably Tyvek.TM.. 
The Tyvek.TM. layer, with the adhesive layer, is then cut into strips with 
the desired width. Alternatively, the Tyvek.TM. layer may be pre-cut to 
the desired width and then the adhesive layer 36 is applied. The base 44 
of the coupling structure 42 is then securely fastened proximate one edge 
of the strip by means such as glue. The releasable backing layer 40 is 
then connected to the adhesive layer 36. The backing layer 40 is then 
"kiss-cut" along the lines 38a, 38b 38c to separate the adhesive layer 
into the desired backing portions 40a, 40b, 40c, 40d. Additionally, the 
backing layer 40 is "kiss-cut" proximate the connection of the coupling 
structure 42 to the arm 32. The "kiss-cut" cuts the backing layer 40, but 
not the underlying Tyvek.TM. layer or the coupling structure 42. The 
individual fittings 14 are then created by means such as stamping, 
punching or die casting; and then apertures 46 in the coupling structure 
42 are similarly created by stamping, punching or die casting. Of course, 
the apertures 46 may be created before the individual fittings 14 are 
cut-out, or simultaneously with fittings 14. Advantageously, the converter 
process allows multiple fittings 14 to created at the same time, which 
decreases the manufacturing costs. 
As discussed above, the coupling structure 42 allows the fitting 14 to be 
connected directly to the patient, or used with various types of 
retainers, such as the retainer 12 above. If the fitting 14 is used with 
the retainer 12, the apertures 46a and 46b are preferably configured to 
engage the posts 24a and 24b extending from the base 16. As shown in the 
accompanying figures, the apertures 46a and 46b preferably have a diameter 
slightly smaller or slightly larger than the protrusions 30 on the posts 
24, and the apertures 46 are preferably spaced in the same general 
configuration and distance apart as the posts 24 extending from the base 
16. 
In operation, if the fitting 14 is being used with the retainer 12, the 
health care provider generally aligns the apertures 46a and 46b with the 
respective posts 24a and 24b. The posts 24a and 24b are then inserted 
through the apertures 46a and 46b. As seen in FIG. 4, the interaction 
between the posts 24a and 24b and the apertures 46a and 46b mounts the 
fitting 14 on the base 16 of the retainer 12. 
FIG. 4 also illustrates the medical tubing 50 connected to the fitting 14. 
In particular, the medical tubing 50 is attached to the fitting 14 by 
wrapping the flexible arms 32 of the fitting 14 around the tubing 50 so 
that the adhesive layer 36 engages the tubing 50. This provides secure 
engagement of the tubing 50 to the fitting 14. Advantageously, the fitting 
14 may be attached anywhere along the length of the tubing 50. Thus, the 
fitting 14 may be placed proximate either end of the tubing 50, or 
somewhere between the ends of the tubing. For example, if the fitting 14 
is used with a catheter, the fitting may be positioned proximate the 
catheter or the fitting may be spaced from the catheter. 
In use, as described in more detail below, for example, the health care 
provider removes backing portion 40b and wraps the flexible arm 32a around 
a portion of the medical tubing 50. The health care provider then removes 
backing portion 40c and wraps the flexible arm 32b around the medical 
tubing 50. The backing portions 40a and 40b desirably allow the health 
care provider to grip the distal ends of the arms 32 without contacting 
the adhesive layer 36. The health care provider may then remove the 
remaining backing portions 40a and 40b to complete attachment of the 
flexible arms 32a and 32b to the medical tubing 50; or the backing 
portions 40a and 40b may remain attached to the flexible arms 32a and 32b 
to facilitate removal of the fitting 14 from the medical tubing 50. 
One of many possible applications for the securing system 10 includes 
attaching the fitting 14 to the tubing 50 so that the tubing 50 extends 
generally parallel to the longitudinal axis of the retainer 12. For 
example, as seen in FIG. 4, flexible arm 32a is wrapped around a portion 
of the tubing 50 in one direction (e.g., to the left) and flexible arm 32b 
is wrapped around another portion of the tubing 50 in an opposite 
direction (e.g., to the right). When the fitting 14 is attached to the 
retainer 12, the tubing 50 extends in the longitudinal direction relative 
to the retainer 12. 
Another application includes attaching the fitting 14 to different types of 
medical tubing, such as Y-type tubing 51. As shown in FIG. 5, the Y-type 
tubing 51 is positioned with the Y-connection proximate the base 16. 
Flexible arm 32a is wrapped around a portion 51a of the tubing 51, and 
flexible arm 32b is wrapped around a portion 51b of tubing 51. Thus, the 
Y-type tubing 51 is securely attached to the fitting 14 by the flexible 
arms 32. 
An additional application includes attaching the fitting 14 to the tubing 
50 so that the tubing 50 extends generally parallel to the lateral axis of 
the retainer 12. For example, the Y-type tubing 51 shown in FIG. 5 extends 
generally in the lateral direction. Additionally, other types of tubing 
may extend in a generally lateral direction relative to the retainer 14. 
For example, as shown in FIGS. 6 and 7, both flexible arms may be wrapped 
around the same portion of tubing 50 so that the tubing 50 is positioned 
generally parallel to the lateral axis of the retainer 12. For example, 
flexible arm 32a may be wrapped around a portion of the tubing 50 and 
flexible arm 32b may be wrapped generally around the same portion of the 
tubing 50 so that the arms 32a and 32b overlap. Indeed, one skilled in the 
art will recognize the flexible arms 32 may be used in a variety of ways 
to attach the medical tubing 50 to the fitting 14. 
One skilled in the art will understand the tubing 50 can be attached to the 
retainer 12 in any desired direction, for example, by shifting the 
orientation of the fitting 14 relative to the retainer 12. Alternatively, 
the positioning of the apertures 46 in the support 44 and/or the posts 24 
relative to the base 16 may be altered to change the orientation of the 
tubing 50 relative to the retainer 12. 
Another embodiment of the securing system 10 is also shown in FIGS. 6 and 
7. In this embodiment, a cover 52 flexibly coupled to the base 16 by a 
flexible leash 54. The leash 54 can take any number of forms to 
mechanically connect the cover 52 to the base 16 while permitting movement 
of the cover 52 relative to the base 16 so as to enable engagement or 
disengagement of these parts, as described below. The cover 52 and leach 
54 are desirably connected to the base 16 so as not to interfere with the 
mounting of the fitting 14. 
In the illustrated embodiment, the leash 54 comprises a band of flexible 
material. The leash 54 desirably is integrally molded with the base 16 and 
the cover 52. The illustrated leash 54 has a longitudinal width of about 
0.5 mm to 5 mm, desirably about 1 mm, and a similar depth or transverse 
dimension. The length of the leash 54 depends in part upon the height of 
the posts 24. The leash 54 is preferably longer than the height of the 
posts 24, to allow some leeway in engaging or disengaging the cover 52 
with the base 16, as understood by one of skill in the art. While the 
leash 54 desirably is generally oblong in cross-section, as illustrated, 
and fixes an orientation of the cover 52 relative to the base 16, it will 
be understood that the leash 54 can also have a string-like (e.g., 
rounded) configuration and allow rotation of the cover 52 about the 
lateral axis. 
The cover 52 is an elongated member which can be formed of the same polymer 
or plastic material as the base 16, and desirably is integrally molded 
with the base 16. The cover 52 desirably has a shape that is generally 
coextensive with the platform 26 of the base 16. For example, the cover 52 
and platform 26 of the base 16 may be elliptical as shown in FIGS. 6 and 
7. Of course, the cover 52 and platform 26 may be square, rectangular, 
circular, or any other desired shape. The cover 52 also can be smaller 
than the platform 26, however, the cover 52 should have a length at least 
sufficient to contact the posts 24 and a width that is at least as wide 
than the posts 24. The width and length of the cover 52 desirably is 
sufficient to securely engage the cover 52 to the posts 24. The corners of 
the cover 52 are also desirably rounded to avoid snagging on materials 
such as the latex gloves worn by the health care provider, bed sheets, 
etc. 
As seen in FIG. 6, the cover 52 desirably includes a textured portion 55, 
such as that formed by longitudinal ridges at an end of the cover 52 
opposite the leach 54. It will be understood that any well known form of 
texturing such as, for example, a roughened surface can be used in place 
of ridges. The textured portion improves the health care provider's grip 
on the cover 52. 
The base 16 and cover 52 are further releasably connected by a latching 
mechanism. The latching mechanism permits the cover 52 to engage the base 
16 in a closed position, as illustrated in FIG. 7. The cover 52 also can 
be disengaged from the base 16 and moved to an open position, as shown in 
FIG. 6. The latching mechanism includes interengaging structures formed on 
the base 16 and on the cover 52. In the illustrated embodiment, a portion 
of the latching mechanism on the base 16 is formed by the posts 24a and 
24b with protrusions 30. 
In particular, the latching mechanism on the cover 52 includes at least one 
aperture 56, and desirably includes the same number of apertures 56 as 
there are posts 24 extending from the base 16. In the illustrated 
embodiment, the cover 52 thus includes two openings apertures 56a and 56b 
which corresponds with the two posts 24a and 24b on the base 16. The 
distance between the apertures 56a and 56b is preferably between about 0.2 
cm and 2 cm, and more preferably about 1.2 cm. Each aperture 56 is 
arranged in the cover 52 to cooperate with the corresponding post 24. It 
will be understood other arrangements of the latching mechanism are 
possible, for example where the posts are attached to the cover and the 
openings are formed in the base. 
Each aperture 56 is defined by a central opening 58 with at least one slot 
60 extending to one side, desirably longitudinally adjacent to and 
intersecting with the central opening 58 at a narrow waist opening 62. The 
central opening 58 is sized and shaped to accommodate the protrusion 30 on 
the post 24. The illustrated slot 60 extends in the longitudinal direction 
from the central opening 58, and the longitudinal axis of the slot 60 is 
generally parallel with the longitudinal axis of the retainer 14. It will 
be understood that the slots 60 in the cover 52 can extend from the 
central opening 58 in any direction, though both slots 60 desirably extend 
in the same general direction. In other arrangements, more than one slot 
can extend from each central opening. 
The width of the illustrated slot 60 in the longitudinal direction is 
smaller than the central opening 58 and is smaller than the protrusion 30 
on the post 24. The width of the slot 60 desirably ranges from slightly 
smaller to slightly larger than the diameter of the shaft 28. The 
interengagement between the posts 24a and 24b and the apertures 56a and 
56b on the cover 52 form the latching mechanism that secures the cover 52 
to the base 16. When the shaft 28 of the post 24 is positioned in the slot 
60, the cover 52 can not be lifted from the base 16 in the transverse 
direction. 
As mentioned above, the base 22, leash 54 and cover 52 desirably are 
integrally formed to make a unitary latching mechanism. This can be 
accomplished in any of a variety of ways well known to one of skill in the 
art. For instance, the entire retainer can be injection molded, in order 
to reduce fabrication costs. Additionally, features such as the leash 54 
are desirably flexible. Suitable plastics which account for these 
considerations include polypropylene, polyethylene, and the like. 
Desirably, the illustrated retainer 12 comprises injection molded 
polyethylene or polypropylene. 
As illustrated in FIG. 7, the cover 52 is latched to the base 16, with the 
support 44 of the fitting 14 interposed between the cover 52 and the base 
16. Desirably, the cover 52 securely mounts the fitting 14 to the retainer 
12. Of course, the securing system 10 does not require the use of the 
cover 52 or latching structure. 
In order to close the cover 52, the apertures 56 of the cover 52 are 
aligned with the posts 24 extending from the base 16. The cover 52 is then 
moved toward the base 16 such that the protrusion 30 of each post 24 
passes through the central opening 58 of corresponding aperture 56. The 
size and spacing of the apertures 56 and the posts 24 should result in an 
easy engagement so that only a light downward force is necessary, thereby 
avoiding pain or discomfort to the patient. In this position, the fitting 
14 is positioned between the cover 52 and the base 16. One skilled in the 
art will understand the rings or other structures may be utilized to limit 
the travel of the cover 52 over the posts 24 so as to properly position 
the cover 52 on the posts 24 generally beneath the protrusions 30. 
The cover 52 is then moved in the longitudinal direction (e.g., to the 
right in FIG. 7) so that the shaft 28 of each post 24 slides past the 
narrow waist opening 62 into the corresponding slot 60. Preferably, the 
material at the waist opening 62 and/or the shaft 28 slightly compresses 
as the cover 52 is moved by the health care provider. Desirably, the cover 
52 is centered with respect to the base 16 when the posts 24 are engaged 
with the slots 60. The resulting engagement serves to retain the fitting 
14 securely in place within the retainer 12. As the waist openings 62 are 
desirably slightly more narrow than the post shafts 28, the slots 60 
provide a friction or snap fit engagement with the posts 24. The slots 60 
are longitudinally more narrow than the protrusions 30, such that the 
cover 52 cannot be transversely lifted away from the base 16 in this 
position. The posts 24 of the base 16 and the slots 60 and the apertures 
58 thereby form the latching structure. The latching structure allows the 
posts 24 to be easily inserted into the apertures 56 in one position but 
inhibits unintentional retraction of the posts 24 from the apertures 56 in 
a second position. 
In operation, the tubing 50 is desirably connected to the fitting 14, for 
example, in any manner described above, and then the fitting 14 is mounted 
to the retainer 12. Of course, the fitting 14 may be first mounted to the 
retainer 12 and then the tubing 50 may be attached to the fitting 14. 
Desirably, the tubing 50 is positioned so as not to interfere with the 
mounting of the fitting 14 to the retainer 12. Additionally, if a cover 52 
is utilized with the securing system 10, the tubing 50 and fitting 14 are 
preferably positioned so as not to interfere with the opening and closing 
of the cover 52. However, the tubing 50, arms 32 and/or leach 54 are 
preferably sufficiently flexible to permit mounting of the tubing 50 and 
fitting 14 in any position relative to the retainer 12. For example, in 
the embodiments shown in FIGS. 6 and 7, the tubing 50 and/or arms 32 are 
sufficiently flexible to allow opening and closing of the cover 52. 
Alternatively, as shown in FIG. 8, the tubing 50 is connected to the 
fitting 14 in a generally longitudinal direction so that the tubing 50 
does not interfere with the closing of the cover 52. 
It will be understood that, in other arrangements, the openings can instead 
be formed in the base, rather than the cover, and the posts formed on the 
cover. In such a case, each opening would comprise a partial central hole 
in the base, below which a hollow space is formed for receiving the heads 
of downward extending posts of the cover. The space would also accommodate 
the lateral movement of the cover (and consequent lateral movement of the 
posts) in order to provide engagement between the shaft of each post and a 
narrow slot extending from the opening. In this manner, the head of one of 
the posts would be captured within the hollow space below each slot. The 
post could not be pulled out of the hollow space because the rear side of 
the post head would contact the portions of the base which define the 
slot. Such a latching mechanism is disclosed in copending application Ser. 
No. 08/587,092, entitled "Catheter Anchoring System", filed on Jan. 15, 
1996, in the name of Steven F. Bierman and assigned to the assignee 
hereof, which stands allowed as of the filing date of this application and 
which is hereby incorporated in its entirety by reference. 
One skilled in the art will understand that the securing system 10 can be 
used to secure medical tubing 50 and a wide variety of other medical 
devices to the patient. For example, medical lines, catheters, electrical 
wires and the like may be attached to the posts 24 by the fitting 12. 
Alternatively, these devices may be directly attached to the posts 24. 
Specifically, box clamps, soft wing clamps and the like may be attached to 
the post 24. In addition, the fitting 14 and these other known medial 
devices can be simultaneously connected to the posts 24. In fact, the 
skilled artisan will find application for the present invention with any 
of these and many other clamp configurations. Further, an inter-line 
connector or adaptor, such as those used to connect the catheter to a 
supply, delivery or drainage line may also be utilized with the present 
invention. 
Another embodiment of the securing system 10 is shown in FIG. 9. In the 
illustrated embodiment, the retainer 12 includes a retention mechanism 70 
comprising a pair of filaments 72 that extend from the base 16. The 
retention mechanism 70, of course, can include one, two, or more than two 
filaments, depending upon the desired use of the securing system 10. Such 
a retention mechanism is disclosed in U.S. Pat. No. 5,637,098 issued on 
Jun. 10, 1997 in the name of Steven F. Bierman, and assigned to the 
assignee hereof, and in copending Ser. No. 08/689,314 entitled "Catheter 
Securement Device," filed on Aug. 7, 1996 in the name of Steven F. 
Bierman, assigned to the assignee hereof, and both are incorporated by 
reference in its entirety. 
Each filament 72 includes a fixed proximal end 74, a free distal end 76 and 
at least one protuberance (generally indicated by reference numeral 78). 
The filaments 72 can have a variety of lengths depending upon the 
particular application of the securing system 10. Preferably, each 
filament 72 has a length of about 2 to 20 cm, and more preferably about 5 
cm; however, much longer or short lengths also are possible. The filaments 
72 also can have a various diameter sizes depending upon the required 
strength of the filaments 72. 
As seen in FIG. 9, each filament 72 includes a plurality of protuberances 
78 arranged in series between the distal end 76 and the proximal end 74 of 
the filament 72. It is contemplated, however, that the filaments 72 can be 
configured to allow a health care provider to form the protuberance 78 in 
the filament 72 by tying a knot toward the distal end 76 of the filament 
72. Additionally, the protuberances 78 generally have identical barb-like 
shapes. In the illustrated embodiment, each protuberance 78 of the 
filament 72 has a generally conical shape with a maximum diameter at a 
proximal end of the protuberance 78. Although not illustrated, the 
protuberances 78 can take a variety of other shapes, such as for example, 
hollow conical shapes, arrow shapes, or transverse rib-like shapes. The 
proximal end of each protuberance 78, however, desirably has a diameter 
which is larger than the diameter of the filament 72. As such, in the 
illustrated embodiment, the proximal end of each protuberance 78 forms a 
flat surface that lies generally transverse to a longitudinal axis of the 
corresponding filament 72. The proximal end surface of some or all of the 
protuberances alternatively can slope or project toward the distal end of 
the filament 72. 
The filament 72 desirably includes a needle-like shaped distal portion 80 
with a generally pointed, but blunt end portion 82 positioned at the 
distal end of the filament 72. The distal portion 80 smoothly tapers with 
increasing diameter from the blunt end portion 82 toward the distal-most 
protuberance 78. The diameter of the distal portion 80 at a point adjacent 
the distal-most protuberance 78 desirably equals the diameter of the 
filament 72 proximal to the protuberances 78. 
The retention mechanism 70 also includes at least one and preferably a 
plurality of receptacles 84 positioned on the base 16. Each receptacle 84 
is arranged on the base 16 to cooperate with at least one filament 72, as 
discussed below. Each receptacle 84 also includes an aperture 86 
configured to engage at least a portion of a filament 72. 
The receptacles 84 receive the distal ends 76 of the filaments 72 in a 
manner permitting the insertion of the filament 72 into the receptacle 84, 
but generally inhibiting the retraction of the filament 72 from the 
receptacle 84. For this purpose, the corresponding filament 72 and 
receptacle 84 include interengaging structure that allows the filament 72 
to be easily inserted into the receptacle 84 in one direction with a first 
degree of force but prevents retraction of the filament 72 when a same or 
greater degree of force is applied to the filament 72 in the opposite 
direction. A larger degree of force is required to retract the filament 72 
from the receptacle 84. 
In the embodiment illustrated in FIG. 9, the interengaging structure 
between the corresponding filament 72 and the receptacle 84 comprises the 
protuberances 78 on the filaments 72 and apertures 86 of the receptacles 
84. The receptacle 84 preferably facilitates insertion of the filament 72 
from both sides of the receptacle. 
The diameter of the aperture 86 is preferably at a minimum at the center of 
the width of the receptacle 84. The minimum diameter desirably is larger 
than the maximum diameter of the filament distal portion 80, but smaller 
than the maximum diameter of the protuberances 78. The receptacle 84 
and/or the protuberances 78 of the associated filaments 72 are preferably 
configured such that a wall of the receptacle 84 about the aperture 86 
and/or the protuberances 78 deflect to allow the larger diameter 
protuberances 78 to pass through the smaller diameter aperture 86 of the 
receptacle 84. Once the protuberance 78 passes through the small end of 
the aperture 86, the protuberance 78 and receptacle 84 spring back to 
inhibit retraction of the protuberance 78 through the aperture 86. 
As shown in FIG. 9, each filament 72 and corresponding receptacle 84 are 
positioned proximate to each other on the base 16. The filaments 72 and 
receptacles 84 desirably are arranged so that the filaments 72 are spaced 
about the same distance apart as the posts 24 shown in FIGS. 1-8. 
Specifically, the filaments 72 are spaced apart by a distance between 0.2 
cm and 2 cm, and more preferably by a distance equal to about 1.2 cm. 
The base 16, filaments 72 and receptacles 84 of the retention mechanism 70 
desirably are integrally formed together. This can be accomplished in any 
of a variety of ways which will be well known to one of skill in the art. 
For instance, the entire retention mechanism 70 can be integrally molded 
of plastic or nylon by injection molding. The retention mechanism 70 
desirably is secured to the anchor pad 18 by means of a solvent bond 
adhesive. A suitable adhesive is available commercially from 3M, Part No. 
4693. 
In operation, the health care provider desirably inserts the filament 72 
through the aperture 46 of the fitting 14 and then through the receptacle 
84. As understood from FIG. 9, the filament 72 has sufficient length to 
extend through the aperture 46 and through the receptacle 84. The health 
care provider likewise inserts the second filament 72 through the aperture 
46 in the fitting 14 and through the receptacle 84. The health care 
provider pulls both filaments 72 tight to draw the support 44 of the 
fitting 14 against the base 16 of the retainer 12. Excess filament length 
can be severed or cut distal to the receptacle 84. The taut filaments 72 
prevent the fitting 14 from moving transversely away from the base 16 and 
from sliding either longitudinally or laterally over the base 16. In this 
manner, the securing system 10 assists maintaining the medical tubing 50 
in a secure position. 
When removal of the fitting 14 becomes necessary, the health care provider 
carefully removes any insertion site dressings which cover the securing 
system 10 and carefully twists the filaments 72 at a point near the 
proximal end 74 of the filament 72 using a blunt hemostat, so as to break 
or sever the filament. The fitting 12 then can be lifted from the base 16. 
As shown in FIGS. 10 and 11, in another preferred embodiment of the present 
invention, a securing system 10 comprising a fitting 90 with a flexible 
arm 92 which is used to engage the medical tubing. The arm 92 is 
preferably between 2 cm and 20 cm in length and, more preferably, about 6 
cm in length. Of course, the arm 92 may have any desired length sufficient 
to engage the medical tubing. As described above, the arm 92 is desirably 
constructed from a flexible material such Tyvek.TM., and at least a 
portion of one side of the arm 92 includes an adhesive layer 94, 
preferably a medical-grade adhesive such as Part No. 9672LE by 3M. A 
removable backing layer 96 desirably covers the adhesive layer 94 before 
use. The backing layer 96 preferably resists tearing and is divided into 
separate portions to ease attachment of the fitting 90 to the medical 
tubing. Desirably, the backing layer 96 is cut along line 98 to form two 
different portions 96a and 96b to facilitate attachment of the medical 
tubing to the fitting 90. 
The fitting 90 includes a coupling structure 100 which comprises a 
generally rectangular structure 102 with two apertures 104a and 104b. The 
arm 92 is desirably attached to the coupling structure 100 at 
approximately a 60.degree. angle, but the arm can be arranged at any 
desired angle, depending, for example, on the type of medical tubing to be 
attached to the fitting 90. The coupling structure 100 desirably allows 
the medical tubing to be attached to the patient. As described above, the 
coupling structure 100 can be sutured in place, or it can be connected to 
various coupling structures. Preferably, the apertures 104a and 104b are 
configured to engage the posts 24a and 24b of the retainer 12 described 
above. Of course, the coupling structure 100 can have different shapes, 
sizes and number of apertures, for example, depending upon the type of 
coupling structure being used to connect the fitting 90 to the patient. As 
seen in FIG. 11, exemplary medical tubing 50 is attaching to the fitting 
90 by wrapping the flexible arm 92 around the tubing so that the adhesive 
layer 94 engages the tubing. This provided secure engagement of the tubing 
50 to the fitting 90. 
In operation, similar to that described above, the health care provider 
removes backing layer 96b and wraps the arm 92 around a portion of the 
medical tubing 50. The health care provider then removes backing layer 96a 
to complete attachment of the arm 92 to the tubing 50, or the backing 
portion 96a may remain attached to the arm 92 to facilitate removal of the 
fitting 90 from the tubing 50. The health care provider may then suture 
the coupling structure 100, for example, to the patient or connect it to 
various coupling structures, such as the retainer 12 discussed above. 
In use, the health care provider selects a site in which the fitting 14 
will be located. For use with CVCs and PICCs, for example, the fitting 14 
is desirably positioned in the vicinity of the catheter insertion site. 
The health care provider then cleanses and prepares the anticipated site 
according to well known methods. The fitting 14 may be directly attached 
to the patient's skin, for example, by suturing. Alternatively, the 
fitting 14 may be used in conjunction with a connector such as the 
retainer 12 described above. In this case, the health care provider peels 
away a portion of the backing layer 20 from the adhesive surface of the 
anchor pad 18, properly locates the pad 18 on the patient, and presses the 
exposed adhesive against the patient's skin to secure a portion of the 
anchor pad 18 to the patient. The remaining portion of the backing layer 
20 is then removed, and the remaining portion of the anchor pad 18 is 
adhered to the patient's skin. The medical tubing 50 is then attached to 
the fitting 14 and retainer 12 in accordance with any of the preferred 
embodiments described above. 
When removal of the medical tubing becomes necessary, the sutures may be 
cut or removed to allow the fitting 14 to be removed from the patient's 
skin, or the fitting 14 may be removed from the posts 24 of the base 16. 
For example, in accordance with the embodiments shown in FIGS. 4 and 5, 
the posts 24 are cut or severed to allow the fitting 14 to be removed. 
Alternatively, in the embodiment shown in FIGS. 6-8, the cover 52 is slid 
longitudinally desirably with force sufficient to compress the cover 
material at the waist openings 62, so that the protrusions 30 on the posts 
24 are once again aligned with the central openings 58. The cover 52 can 
then be easily lifted transversely from the base 16. With the retainer 12 
thus unlatched, the fitting 14 can also be removed. Further, as shown in 
FIG. 8, the filaments 72 may be cut or twisted off between the proximal 
ends 74 and the corresponding receptacles 84 to allow removal of the 
fitting 14 from the retainer 12. 
The medical tubing 50 secured by the fitting 14 can then be changed or 
cleaned and replaced, without requiring a new retainer 12 be attached to 
the patient. Of course, if the medical treatment is completed and there is 
no need to reuse the retainer 12, the health care provider can release the 
fitting 14 from the retainer 12 in the manner described above and the 
fitting 14 is then removed from the base 16. To remove the anchor pad 18, 
the health care provider lifts an edge of the pad 18 and gently strokes 
the undersurface with an alcohol swab while slowly but continuously 
lifting the edge. The anchor pad 18 can be peeled from the patient's skin 
in this manner. The health care provider then cleanses and prepares skin 
using well known hospital or agency protocols. 
The skilled artisan will appreciate that the securing systems disclosed 
herein have great versatility in securing a wide variety of medical 
articles to a patient. Securing systems similar to those shown in the 
attached figures and described herein can be utilized to secure devices of 
various shapes and sizes. Moreover, these securing systems can be utilized 
with or without an associated cover. This securing system can also be used 
with a great many medical devices with suture holes which can be fitted 
over the retainer posts disclosed herein. Other devices can be modified to 
include such holes. Other arrangements to secure a medical article to the 
posts, either between the posts or adjacent to a single post, will be 
readily apparent to those skilled in the art in light of the disclosure 
herein. 
Alternatively, one of skill in the art will readily appreciate that the 
disclosed securing systems can be modified, without departing from the 
spirit of the invention, to mount and retain existing medical devices. For 
example, the securing system can be adapted to clamp existing Y-joint 
adapters, or to directly mount a catheter or other medical line. 
Desirably, any such modified mounting structure would inhibit longitudinal 
and lateral movement of the device or medical line. Transverse movement is 
inhibited by closure of the retainer with the device or line sandwiched 
between the base and the cover. 
Although not illustrated, the securing system can be adapted for use in an 
system which includes a safety loop. An anchor pad larger than the pad 18 
can mount both a retainer and a separate tube clip. The medical tubing 
mounted by the retainer can also be secured less tightly to the tube clip, 
with an adequate amount of slack in the line between the retainer and the 
clip. The clip and the resultant slack are desirably located between the 
retainer and the catheter insertion site, for example. 
If movement by the patient causes a sudden pull upon the medical tubing, 
the tubing slips within the tube clip and the slack length or "safety 
loop" of the tube is pulled through the clip. Friction between the clip 
and the sliding tube absorbs some of the force and some of the force 
causes a slight pull on the adhesive pad, functioning as a warning to the 
patient to cease the undesirable movement. 
When using a retainer in accordance with the above disclosure, no painful, 
invasive or time-consuming sutures or other extensive procedures involving 
medical sharps (e.g., suture needles) are necessary to secure medical 
tubing to a patient. In addition, the flexible anchor pad absorbs much of 
the force incurred in the installation or removal of the retainer and the 
fitting, thereby providing greater comfort for the patient. 
The present invention, when used in conjunction with a retainer, provides a 
sterile (or non-sterile), tight-gripping, needle-free way to secure 
medical tubing to a patient. The securing systems eliminate accidental 
needle sticks, suture wound site infections and scarring because sutures 
are not required. In addition, the retainers can be used with any of a 
wide variety of catheters, tubes, wires, and other medical articles to 
provide universal securement using one style of retainer. Also, patient 
comfort is enhanced and application time is decreased with the use of the 
present retainer. 
Advantageously, these securing systems allow the same retainer to be used 
more than once on the same patient at the same location. That is, a first 
medical device can be mounted to the retainer. When the function of the 
first medical device is accomplished, the first medical device is removed, 
and a second medical device can be mounted to the same retainer. 
Although this invention has been described in terms of certain preferred 
embodiments and suggested possible modifications thereto, other 
embodiments and modifications apparent to those of ordinary skill in the 
art are also within the scope of this invention. Accordingly, the scope of 
the invention is intended to be defined only by the claims which follow.