U.S. patent application number 13/291464 was filed with the patent office on 2012-03-08 for intravenous catheter anchoring device.
This patent application is currently assigned to Venetec International, Inc.. Invention is credited to Steve A. Cash, W. Cary Dikeman, Larry C. Smith, Chris Winsor.
Application Number | 20120059328 13/291464 |
Document ID | / |
Family ID | 38174676 |
Filed Date | 2012-03-08 |
United States Patent
Application |
20120059328 |
Kind Code |
A1 |
Dikeman; W. Cary ; et
al. |
March 8, 2012 |
INTRAVENOUS CATHETER ANCHORING DEVICE
Abstract
An intravenous catheter anchoring assembly is disclosed and
includes a patient-contacting membrane, a platform, and a retaining
strap for securing a catheter or tubing of an administration set to
a patient. The strap is attached to the platform with adjustable
pull-tabs that permit a variety of catheter shapes and sizes to be
secured. The strap is also elastomeric so that the strap is
stretchable and thereby grabs the secured catheter. The strap and
platform further define a plurality of passageways that permit the
catheter to be secured in a plurality of non-aligned
directions.
Inventors: |
Dikeman; W. Cary; (Lenexa,
KS) ; Winsor; Chris; (Olathe, KS) ; Cash;
Steve A.; (Overland Park, KS) ; Smith; Larry C.;
(Shawnee, KS) |
Assignee: |
Venetec International, Inc.
Covington
GA
|
Family ID: |
38174676 |
Appl. No.: |
13/291464 |
Filed: |
November 8, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11306289 |
Dec 21, 2005 |
8052648 |
|
|
13291464 |
|
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Current U.S.
Class: |
604/179 |
Current CPC
Class: |
A61M 25/02 20130101;
A61M 2025/0246 20130101; A61M 2025/024 20130101; A61M 2025/0253
20130101 |
Class at
Publication: |
604/179 |
International
Class: |
A61M 25/02 20060101
A61M025/02 |
Claims
1. An intravenous catheter anchoring device for securing a catheter
to a patient, wherein the catheter includes a distal section
configured to be at least partially inserted into the patient and a
proximal section, said device comprising: a platform including a
base and a plurality of connectors, said base forming at least part
of an internal surface, said internal surface including a trough to
receive said catheter; and a retaining strap cooperating with said
internal surface of said platform to define a catheter-receiving
passageway configured to receive a portion of said catheter with
said proximal and distal sections projecting outwardly therefrom,
said retaining strap comprising an elastomeric body, said body
including spaced apart pull-tabs each being removably attached to a
corresponding one of said connectors, with said body being
elastically stretched when said catheter portion is received in
said passageway wherein said catheter is gripped and thereby
axially retained by said device.
2. The intravenous catheter anchoring device as in claim 1, wherein
said retaining strap is less rigid than said platform, so that said
platform substantially retains its shape when said elastomeric body
is elastically stretched to receive said catheter in said
passageway.
3. The intravenous catheter anchoring device as in claim 1, wherein
said retaining strap is formed of a first material and said
platform being formed of second material, said first material
having greater elasticity than said second material.
4. The intravenous catheter anchoring device as in claim 1, wherein
said elastomeric body is configured so that strain varies along the
length thereof when said body is elastically stretched.
5. The intravenous catheter anchoring device as in claim 1, wherein
said elastomeric body includes a stretch portion and a pull-tab,
said elastomeric body being configured so that said stretch portion
undergoes greater strain than said pull-tab when said body is
elastically stretched.
6. The intravenous catheter anchoring device as in claim 5, wherein
said stretch portion is centrally located to partially define said
catheter-receiving passageway, said pull-tab being removably
attached to said platform.
7. The intravenous catheter anchoring device as in claim 1, wherein
said trough has an arcuate shape and forms at least part of said
internal surface.
8. The intravenous catheter anchoring device as in claim 7, wherein
said arcuate trough includes opposite ends, said arcuate trough
sloping downwardly toward one of said ends thereof.
9. The intravenous catheter anchoring device as in claim 8, wherein
said base comprises a stop adjacent said one of said ends so as to
resist axial movement of said catheter along said trough in the
direction of said stop.
10. The intravenous catheter anchoring device as in claim 1,
wherein said trough is configured to extend at least partly around
said catheter.
11. The intravenous catheter anchoring device as in claim 1,
wherein said trough has a maximum cross-sectional dimension, and
wherein said base includes a tubing catch projecting inwardly
relative to said maximum cross-sectional dimension so as to
releasably retain said catheter within said trough.
12. The intravenous catheter anchoring device as in claim 11,
wherein said trough has an arcuate cross-sectional shape, and
wherein said trough extends about an arc equal to or less than
about 180 degrees, said tubing catch extending radially inward
relative to said arc.
13. The intravenous catheter anchoring device as in claim 11,
wherein said base includes a plurality of troughs and tubing
catches.
14. An intravenous catheter anchoring device for securing a
catheter to a patient, wherein said catheter includes a distal
section configured to be at least partially inserted into said
patient and a proximal section, said device comprising: a platform
configured for removable attachment to said patient, said platform
having a base and a connector, said base forming at least part of
an internal surface, said internal surface including a trough to
receive said catheter; and a retaining strap cooperating with said
platform to define a catheter-receiving passageway configured to
receive a portion of said catheter with said proximal and distal
sections projecting outwardly therefrom, said retaining strap
comprising an elongated flexible body having spaced apart opposite
ends, one of which is coupled to said platform and the other which
is removably attached to said connector, said flexible body
including a plurality of discrete attachment locations spaced along
the length of said flexible body, with each of said attachment
locations being releasably connectable to said connector, said
catheter-receiving passageway having an adjustable cross-sectional
dimension that varies depending upon which attachment location is
connected to said connector.
15. The intravenous catheter anchoring device as in claim 14,
wherein said trough has an arcuate shape.
16. The intravenous catheter anchoring device as claim 15, wherein
said arcuate trough includes opposite ends, said arcuate trough
sloping downwardly toward one of said ends thereof, with said base
including a stop adjacent said one of said ends so as to resist
axial movement of said catheter along said trough in the direction
of said stop.
17. The intravenous catheter anchoring device as in claim 14,
wherein said trough is configured to extend at least partly around
said catheter, and wherein said trough has a maximum
cross-sectional dimension, said base including a tubing catch
projecting inwardly relative to said maximum cross-sectional
dimension so as to releasably retain said catheter within said
trough.
18. The intravenous catheter anchoring device as in claim 17,
wherein said trough has an arcuate cross-sectional shape extends
about an arc equal to or less than about 180 degrees, said tubing
catch extending radially inward relative to said arc.
19. An intravenous catheter anchoring device for securing a
catheter to a patient, wherein said catheter includes a distal
section configured to be at least partially inserted into said
patient and a proximal section, said device comprising: a platform
including a base and a plurality of connectors, said base forming
at least part of an internal surface, said internal surface
including a trough to receive said catheter; and a retaining strap
cooperating with said plurality of connectors to define a plurality
of non-aligned catheter-receiving passageways, each being
configured to receive a portion of said catheter with said proximal
and distal sections projecting outwardly therefrom, said
passageways cooperatively providing multiple catheter orientations
relative to said device, said platform and strap being intercoupled
at least at more than two coupling locations, said platform and
strap cooperatively defining a plurality of catheter-receiving
openings, each of which is between adjacent ones of said coupling
locations, each of said passageways extending between a
corresponding pair of catheter-receiving openings.
20. The intravenous catheter anchoring device as in claim 19,
wherein said trough forms a portion of said catheter-receiving
passageways.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a divisional of co-pending application Ser. No.
11/306,289, filed Dec. 21, 2005, entitled INTRAVENOUS CATHETER
ANCHORING DEVICE, which was filed contemporaneously with
Application for U.S. Design Pat. Ser. No. 29/245,311, entitled
INTRAVENOUS SITE SECUREMENT DEVICE FOR CATHETERS, each of which is
hereby expressly incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to the field of
intravenous infusion site devices. More specifically, the present
invention concerns an intravenous catheter anchoring device for the
securement of catheters on various patient sites.
[0004] 2. Description of the Related Art
[0005] Catheters for intravenous infusion into a patient are well
known in the art. Such catheters are generally used in a variety of
infusion applications and on a variety of sites. For example,
catheters are commonly used as central venous catheters ("CVC"),
midline catheters, or peripherally inserted central catheters
("PICC"). These catheters normally are used with some sort of a
catheter anchoring device for attaching the catheter to the
patient.
[0006] One such anchoring device is an intravenous site securement
device for preventing catheter movement. The securement device is
important because catheter location within the venous system is
usually critical. For example, a catheter that dispenses medicine
to an internal organ often must have its tip positioned in a
particular location or the medicine will not have its intended
effect. Moreover, patients with these catheters often want or need
to have a normal range of body motion while the catheter is
inserted. Patient movement as well as external objects can apply
external forces to the catheter and thereby shift the catheter's
location within the venous system. These forces can cause, in
particular, back-and-forth dynamic movement of the tip, sometimes
referred to as "pistoning." These forces can also cause a static
shift in the catheter tip from its original location.
[0007] Another type of catheter anchoring device is a tubing
collector. The tubing collector generally serves to secure an
excess length of tubing from a catheter, intravenous extension set,
or intravenous administration set. Also, some tubing collectors
tend to permit axial movement of the secured tubing. Therefore,
people have a need for catheter anchoring devices that provide
reliable catheter securement during patient movement or while an
external force is applied.
[0008] Again, anchoring devices are often used with catheters to
prevent or restrict catheter movement. However, these anchoring
devices are problematic and suffer from various undesirable
limitations. One limitation for site securement devices with tape
or sutures holding the catheter in place is that they tend to start
or promote infections at that location. Furthermore, these
securement devices often are able to receive only one size and
shape of catheter hub (e.g., a suture hub, Y-site hub, or luer
fitting). One limitation for anchoring devices in general is that
catheter attachment is difficult, requiring precise, two-handed
manipulation. Anchoring devices are also problematic because they
can be inadvertently pulled from the skin's surface. Another
limitation is that anchoring devices are not adapted for use with a
variety of catheter sizes and shapes. Accordingly, there is a need
for an improved intravenous catheter anchoring device that does not
suffer from these problems and limitations.
SUMMARY OF THE INVENTION
[0009] The present invention provides an intravenous catheter
anchoring device that does not suffer from the problems and
limitations of the prior art catheter anchoring devices detailed
above.
[0010] In particular, a first aspect of the present invention
concerns an intravenous catheter anchoring device for securing a
catheter to a patient, wherein the catheter includes a distal
section configured to be at least partially inserted into the
patient and a proximal section. The device broadly includes a
platform configured for removable attachment to the patient and a
retaining strap. The retaining strap cooperates with the platform
to define a catheter-receiving passageway that is configured to
receive a portion of the catheter with the proximal and distal
sections projecting outwardly therefrom. The retaining strap
comprises an elastomeric body. The body is elastically stretched
when the catheter portion is received in the passageway such that
the catheter is gripped and thereby axially retained by the
device.
[0011] A second aspect of the present invention concerns an
intravenous catheter anchoring device for securing a catheter to a
patient, wherein the catheter includes a distal section configured
to be at least partially inserted into the patient and a proximal
section. The device broadly includes a platform configured for
removable attachment to the patient and a retaining strap. The
platform presents a connector. The retaining strap cooperates with
the platform to define a catheter-receiving passageway configured
to receive a portion of the catheter with the proximal and distal
sections projecting outwardly therefrom. The retaining strap
comprises an elongated flexible body presenting spaced apart
opposite ends, one of which is coupled to the platform and the
other which is removably attached to the connector. The body
includes a plurality of discrete attachment locations spaced along
the length of the body, with each of the attachment locations being
releasably connectable to the connector. The catheter-receiving
passageway presents an adjustable cross-sectional dimension that
varies depending upon which attachment location is connected to the
connector.
[0012] A third aspect of the present invention concerns an
intravenous catheter anchoring device for securing a catheter to a
patient, wherein the catheter includes a distal section configured
to be at least partially inserted into the patient and a proximal
section. The device broadly includes a platform configured for
removable attachment to the patient and a retaining strap. The
retaining strap cooperates with the platform to define a plurality
of non-aligned catheter-receiving passageways, each being
configured to receive a portion of the catheter with the proximal
and distal sections projecting outwardly therefrom. The passageways
cooperatively provide multiple catheter orientations relative to
the device. The platform and strap are intercoupled at more than
two coupling locations. The platform and strap cooperatively define
a plurality of catheter-receiving openings, each of which is
between adjacent ones of the coupling locations. Each of the
passageways extends between a corresponding pair of
catheter-receiving openings.
[0013] A fourth aspect of the present invention concerns a method
of securing a catheter to a patient. The method broadly includes
the steps of attaching an intravenous catheter anchoring device to
the patient, and attaching the catheter to the intravenous catheter
anchoring device so as to restrict axial movement of the catheter
relative to the device. The step of attaching the catheter to the
anchoring devices includes the step of gripping the catheter with
an elastically stretched retaining strap of the catheter anchoring
device.
[0014] Other aspects and advantages of the present invention will
be apparent from the following detailed description of the
preferred embodiments and the accompanying drawing figures.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0015] Preferred embodiments of the invention are described in
detail below with reference to the attached drawing figures,
wherein:
[0016] FIG. 1 is a perspective view of an intravenous infusion site
assembly including an intravenous catheter anchoring assembly
constructed in accordance with a preferred embodiment of the
present invention, particularly showing the anchoring assembly as
it secures a multi-lumen catheter with a Y-site suture hub of a
central venous catheter to a patient;
[0017] FIG. 2 is a perspective view of the intravenous catheter
anchoring assembly depicted in FIG. 1, but showing the assembly as
it secures a single-lumen catheter with a suture hub of a
peripherally inserted central catheter to the patient's arm;
[0018] FIG. 3 is a perspective view of the intravenous infusion
site assembly shown in FIGS. 1 and 2, particularly showing the
securement of a catheter including a catheter suture hub in a
transverse direction relative to the catheter anchoring
assembly;
[0019] FIG. 4 is a perspective view of the intravenous infusion
site assembly of FIGS. 1 and 2, particularly showing the securement
of the catheter including the catheter suture hub in a lengthwise
direction relative to the catheter anchoring assembly;
[0020] FIG. 5 is a side elevational view of the intravenous
infusion site assembly shown in FIG. 3;
[0021] FIG. 6 is an exploded perspective view of the intravenous
infusion site assembly shown in FIG. 3, particularly illustrating
the patient-contact membrane, the platform, and the retaining
strap;
[0022] FIG. 7 is a perspective view of the intravenous catheter
anchoring assembly, showing the platform and particularly the lower
surface of the retaining strap;
[0023] FIG. 8 is a perspective view of a second embodiment of the
intravenous catheter anchoring assembly showing a first alternative
platform;
[0024] FIG. 9 is a perspective view of a third embodiment of the
intravenous catheter anchoring assembly showing a second
alternative platform;
[0025] FIG. 10 is a perspective view of a fourth embodiment of the
intravenous catheter anchoring assembly showing a first alternative
retaining strap;
[0026] FIG. 11 is a perspective view of a fifth embodiment of the
intravenous catheter anchoring assembly showing a second
alternative retaining strap;
[0027] FIG. 12 is a top view of a sixth embodiment of the
intravenous catheter anchoring assembly, showing a third
alternative retaining strap that is H-shaped;
[0028] FIG. 13 is a top view of a seventh embodiment of the
intravenous catheter anchoring assembly, showing a fourth
alternative retaining strap that is U-shaped;
[0029] FIG. 14a is a top view of an eighth embodiment of the
intravenous catheter anchoring assembly, showing a fifth
alternative retaining strap that includes non-unitary strap
portions secured in a parallel relationship;
[0030] FIG. 14b is a top view of the intravenous catheter anchoring
assembly shown in FIG. 14, but illustrating the non-unitary strap
portions secured in an overlying relationship;
[0031] FIG. 15 is a perspective view of a ninth embodiment of the
intravenous catheter anchoring assembly, showing a sixth
alternative retaining strap and a third alternative platform that
are hingedly connected;
[0032] FIG. 16 is an exploded perspective view of the intravenous
catheter anchoring assembly shown in FIG. 15;
[0033] FIG. 17 is a perspective view of a tenth embodiment of the
intravenous catheter anchoring assembly, showing a seventh
alternative retaining strap and a fourth alternative platform that
cooperatively form an alternative hinged connection and where the
platform includes first alternative connectors;
[0034] FIG. 18 is an exploded perspective view of the intravenous
catheter anchoring assembly shown in FIG. 17;
[0035] FIG. 19 is a perspective view of an eleventh embodiment of
the intravenous catheter anchoring assembly, showing an eighth
alternative retaining strap and a fifth alternative platform that
cooperatively form an alternative hinged connection and where the
platform includes second alternative connectors;
[0036] FIG. 20 is an exploded perspective view of the intravenous
catheter anchoring assembly shown in FIG. 19;
[0037] FIG. 21 is a perspective view of a twelfth embodiment of the
intravenous catheter anchoring assembly, wherein the assembly
comprises a tubing collector;
[0038] FIG. 22 is a perspective view of the intravenous catheter
anchoring assembly shown in FIG. 21 with the retaining strap
partially detached from the platform and the catheter tubing
removed;
[0039] FIG. 23 is a perspective view of a thirteenth embodiment of
the intravenous catheter anchoring assembly, similar to that shown
in FIGS. 21 and 22, but with the platform being alternatively
configured;
[0040] FIG. 24 is a side view of the intravenous catheter anchoring
assembly shown in FIG. 23, illustrating the retaining strap
attached to the platform to secure tubing therein and the grooved
lower surface of the platform;
[0041] FIG. 25 is a perspective view of a fourteenth embodiment of
the intravenous catheter anchoring assembly, which comprises a site
securement device for securing an alternative catheter;
[0042] FIG. 26 is a perspective view of the intravenous catheter
anchoring assembly shown in FIG. 25, with the retaining strap
partially detached and the catheter removed;
[0043] FIG. 27 is a perspective view of a fifteenth embodiment of
the intravenous catheter anchoring assembly, which comprises a site
securement device for securing a catheter;
[0044] FIG. 28 is a side view of the intravenous catheter anchoring
assembly shown in FIG. 27, showing the retaining strap partially
attached to the platform with the catheter positioned
therebetween;
[0045] The drawing figures do not limit the present invention to
the specific embodiments disclosed and described herein. The
drawings are not necessarily to scale, emphasis instead being
placed upon clearly illustrating the principles of the
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0046] An intravenous catheter anchoring assembly 10 for use in
securing a catheter 12 to a patient P is illustrated in FIG. 1. The
catheter anchoring assembly 10 is combined with the catheter 12 to
form an intravenous infusion site assembly 14. In the usual manner,
the infusion site assembly 14 is connected to an intravenous
administration set (not shown) and enables convenient and
repetitive porting to the patient's internal venous system for
intravenous therapy and generally for introducing or removing
fluids. More specifically, the illustrated catheter anchoring
assembly 10 functions as an intravenous site securement device for
removably attaching the catheter 12 to the patient P to prevent
localized catheter movement, especially any axial catheter
movement, i.e., "pistoning".
[0047] As will be shown, other catheter anchoring embodiments
disclosed herein function primarily as a tubing collector. As
previously discussed, tubing collectors generally permit removable
attachment of the tubing of a catheter, an intravenous extension
set, or of an intravenous administration set to the patient P and
principally serve to store an excess length of that tubing (see
FIG. 21).
[0048] The illustrated embodiment of FIG. 1 specifically shows the
infusion site assembly 14 with the catheter 12 secured to the
patient's chest C as a CVC. However, the catheter 12 may be
introduced into a fluid stream other than the blood stream without
departing from the scope of the present invention. In particular,
the illustrated catheter anchoring assembly 10 provides an external
mechanism for stabilizing the catheter's position in various
locations on the patient P. For example, FIG. 2 illustrates the
catheter anchoring assembly 10 used to secure a catheter 16 on an
arm A of the patient P as a PICC. In either case, the illustrated
catheter anchoring assembly 10 broadly includes a
patient-contacting membrane 18, a platform 20 adhesively attached
to the membrane 18, and a retaining strap 22 removably attached to
the platform 20. As discussed, the catheters 12, 16 permit fluids
to be introduced and removed from the patient's venous system.
[0049] The catheter 12 includes tubing 24 having an internal bore
(not shown) that is also referred to as a lumen. The catheter 12
further includes proximal and distal sections 26, 28 (with
"proximal" and "distal" referring to the relative proximity to the
intravenous administration set). The distal section 28 extends into
and out of the patient's body at a puncture location 30 (sometimes
referred to as a venipuncture site). The distal section 28 also
terminates at a Y-site suture hub 32. The proximal sections 26
terminate at the suture hub 32 and at ends 34 which are formed by
female luer fittings. The proximal sections 26 of the CVC catheter
12 each include a single lumen, making the catheter 12 a double
lumen catheter. The lumens are configured in the usual manner to
carry fluids to and from the patient P. The catheter 12 also
includes clamps 36 that occlude the tubing 24 by sealing the lumen
and thereby prevent the flow of fluid from one end to the
other.
[0050] The single lumen catheter 16, as shown in FIGS. 2-6,
includes proximal and distal sections 38, 40. The catheter 16
further includes tubing 42 with a single lumen 44 that extends into
and out of the patient's arm A and is configured in the usual
manner to carry fluids to and from the patient P. The catheter 16
further includes a suture hub 46 with the tubing 42 extending
outwardly therefrom. As shown particularly in FIG. 6, the suture
hub 46 includes a body 48 and oppositely extending wing-shaped
projections 50. The projections 50 each include a hole 52 for
securing the suture hub 46 with a suture. The body 48 is
cylindrically shaped and includes tapered strain relief sections 54
that restrict some bending of the tubing 42 adjacent to the
projections 50. The body 48 further includes an annular groove 56
(sometimes referred to as a suture groove).
[0051] As shown in FIG. 25, another single lumen catheter 58
includes a distal tubing section 60 which, again carries fluids to
and from the patient (not shown). The catheter 58 further includes
a female luer fitting 62 which mates to an intravenous
administration set 64. The intravenous administration set 64
includes a male luer fitting 66 for mating with the female fitting
62. These fittings 62, 66 form a separable catheter hub 68. The
intravenous administration set 64 further includes a proximal
tubing section 70 that terminates at the male fitting 66. While the
above described catheters 12, 16, 58 include features that are
important with respect to some aspects of the invention, it is
entirely consistent with the principles of the present invention to
use other types of catheters not depicted with the disclosed
embodiments of the catheter anchoring assembly. Moreover, the
present invention is ideally and advantageously suited for securing
a broad range of catheter shapes and sizes.
[0052] Turning back to FIGS. 3-6, the patient-contacting membrane
18 is preferably an adhesive strip that includes a substrate 72.
Referring to FIG. 6, the substrate 72 includes ends 74 and recessed
sides 76 extending longitudinally between the ends 74. The ends 74
each include two extended portions 78 and recessed scallops 80
between the pair of extended portions 78. The shape of the
illustrated membrane 18 is intended for ornamental purposes and is
the subject of co-pending U.S. Design patent application No.
29/253,412, filed Feb. 6, 2006, entitled ADHESIVE PATIENT-CONTACT
STRIP FOR INTRAVENOUS CATHETER ANCHORING DEVICES, which is hereby
incorporated by reference herein. The illustrated substrate 72 is a
flexible, non-woven tricot fabric preferably including polyester
filaments. However, it is consistent with the principles of the
present invention to use other woven or non-woven fabrics.
[0053] The membrane 18 further includes a first adhesive layer 82
(see FIG. 2) coated over a lower side 84 of the substrate 72. The
adhesive layer 82 is preferably a pressure-sensitive adhesive
("PSA") including an acrylic resin material and is suitable for
adhering itself to the substrate 72 as well as being removably
adherent to human skin More preferably, the adhesive layer 82 is
provided with the substrate 72 as a pre-assembled adhesive-backed
membrane. One preferred adhesive-backed membrane is "Tricot PSA",
sold by Hi-Tech Products, 8530 Roland St., Buena Park, Calif.
90621. The substrate 72 and adhesive layer 82 cooperatively permit
the membrane 18 to be flexible and breathable and is thereby
suitable for removable attachment to the skin of patient P. The
membrane 18 includes a removable release layer (not shown) with
tabs. The release layer covers the adhesive layer 82 and the tabs
permit the release layer to be easily removable from the adhesive
layer 82. In this manner, the adhesive layer 82 may be exposed just
prior to adhering the membrane 18 to the patient's skin.
[0054] Turning to FIG. 6, a second adhesive layer 86 is applied to
an upper side 88 of the substrate 72. The adhesive layer 86 is
preferably an adhesive transfer tape that is suited for bonding
fabrics or textured surfaces. More preferably, the adhesive layer
86 is an acrylic adhesive transfer tape, Type 964, manufactured by
3M, Engineered Adhesives Division, St. Paul, Minn. 55144-1000. The
adhesive layer 86 is a flexible but solid material that is cut to
closely follow the shape of the platform 20 in order to maximize
the bonded surface area between the platform 20 and the substrate
72. However, it is consistent with the principles of the present
invention that the adhesive layer 86 could be applied in a form
more similar to a liquid and could be applied by pouring or
spraying methods known to those of ordinary skill in the art. The
adhesive layers 82,86 and their interaction with the platform 20
and the membrane 18 are the subject of co-pending U.S. patent
application Ser. No. 11/457,279, filed Jul. 6, 2006, entitled
INTRAVENOUS SECUREMENT DEVICE WITH ADHESIVELY INTERCONNECTED
ANCHORING COMPONENT AND PERMEABLE ADHESIVE STRIP, which is hereby
incorporated by reference herein.
[0055] Referring to FIGS. 3-7, the preferred platform 20 is unitary
and includes a base 90 and connectors 92. The base 90 is shaped
like a flat plate and includes upper and lower surfaces 94, 96 and
a contoured edge 98 (see FIG. 5). The contoured edge 98 is formed
with rounded corners 100 and recessed scallops 102 between each of
the corners 100 (see FIG. 6). The upper and lower surfaces 94, 96
are substantially flat and give the base 90 a uniform thickness.
However, as will be discussed in other embodiments, the base 90 can
include alternatively shaped surfaces for receiving the catheter 16
without departing from the principles of the present invention. The
base 90 could further have an alternative surface that is shaped to
closely match the shape of the catheter 16, including the catheter
hub 46.
[0056] The connectors 92 each include a post 104 having a rounded
head end 106. As shown particularly in FIG. 5, the head end 106 is
preferably frusto-spherical in shape, with a spherical portion and
a flat 108. Also, the head end 106 is larger in diameter than the
post 104. Referring back to FIG. 6, each of the posts 104 have a
proximal end opposite from the head end 106 that is attached
adjacent a respective corner 100 of the base 90. The posts 104
include two pairs that diverge upwardly from the upper surface 94
so that the head ends 106 are spaced apart further than the
proximal ends.
[0057] The connectors 92 also form primary and secondary attachment
sides 110,112. A first pair of the connectors 92 extend parallel to
each other in a first lateral direction and are similarly angled
relative to the base 90 so that they cooperatively define a primary
attachment side 110 of the platform 20. A second pair of the
connectors 92 also extend parallel to each other and cooperatively
form another primary attachment side 110. The second pair are also
angled relative to the base 90 at an angle similar to the first
pair, but extend in an opposite lateral direction from the first
pair. Each of the connectors 92 are spaced apart so that the
distance between any two adjacent connectors 92 is about the same
(thus forming the corners of an imaginary square). Therefore,
adjacent connectors 92 that extend in opposite lateral directions
from each other cooperatively form secondary attachment sides 112
of the platform 20.
[0058] In the preferred embodiment, the connectors 92 and base 90
are integrally injection molded of a relatively hard plastic to
create the unitary platform 20. Alternatively, the platform 20 can
be molded to include a relatively flexible elastomeric insert
material (e.g., silicone). Elastomeric materials generally have a
lower modulus of elasticity than hard plastic materials and also
provide surfaces with a higher coefficient of friction. Therefore,
such a material can be incorporated into the platform 20 so that
the platform 20 has a surface that grips the catheter 16.
Specifically, the elastomeric structure grips the catheter 16 by
frictionally engaging and by flexibly conforming to the catheter
16.
[0059] While the use of elastomeric materials, such as silicone, is
preferred for enabling the intravenous catheter anchoring assembly
10 to frictionally engage the catheter 16, for other aspects of the
invention, it is also preferred to treat portions of the elastomer
surface so that it is soft and has a relatively low coefficient of
friction. In particular, for surfaces that come into contact with
the patient's skin, the relatively sticky feel of silicone can be
uncomfortable for the patient. One preferred solution is the
application of a Parylene coating to the silicone (or other
substrate) using a vapor deposition process. The process creates a
uniform polymer film over the substrate that has a relatively soft
feel against the patient's skin and is relatively slick. While the
Parylene coating is not preferred for the catheter-gripping
surfaces of the illustrated platform 20, other surfaces could
include Parylene, particularly where those surfaces come into
direct contact with the patient P.
[0060] Referring again to FIG. 6, the platform 20 is arranged so
that the sides 110 are spaced adjacent to respective recessed sides
76 of the membrane 18. The platform 20 is bonded to the substrate
72 of membrane 18 with the adhesive layer 86. In particular, the
adhesive layer 86 is bonded to the lower surface 96 and the upper
side 88 of the substrate 72. Again, the features of the adhesive
layer are further disclosed in the above incorporated Application.
While the platform 20 is preferably adhered to the membrane 18, it
is also within the ambit of the present invention that the platform
20 could be attached to the membrane 18 by other suitable
manufacturing methods such as RF welding, ultrasonic welding, heat
staking, or overmolding.
[0061] The combined platform 20 and membrane 18 are removably
attachable to the patient's skin as discussed above. The membrane
18 flexes to conform to curved surfaces in the attachment site.
Furthermore, the contoured shape of the relatively rigid platform
20 permits the platform 20 to remain bonded to the membrane 18
while being closely arranged to the patient's skin even if it
includes significant curvature.
[0062] Turning back to FIGS. 3-7, the catheter anchoring assembly
10 includes the retaining strap 22. The preferred retaining strap
22 is unitary and is generally elongated and flat, although other
suitable shapes and configurations are within the ambit of the
present invention. As will be discussed in greater detail, the
retaining strap 22 is also preferably flexible and elastomeric (see
FIG. 3) to permit frictional engagement with the catheter 16 and to
conform to the shape of the catheter 16.
[0063] Referring to FIGS. 6 and 7, the retaining strap 22 includes
a body 114. The body 114 includes spaced apart opposite attachment
ends 116, each formed by a pair of outwardly extending pull-tabs
118,120, and a centrally located stretch portion 122 between the
ends 116. The body 114 presents upper and lower surfaces 124,126.
The pull-tabs 118 provide a grasping surface for the retaining
strap 22 and each provides an attachment location preferably in the
form of a through-hole 128 for receiving a respective one of the
connectors 92 as will be discussed. In the preferred embodiment,
the pull-tabs 120 are adjustable and have an elongated shape to
include three attachment locations, each in the form of
through-hole 128. The body 114 includes reinforced edges 130
(preferably in the form of a raised rib extending about the
perimeter) that surround respective holes 128 to enhance structural
integrity and prevent tearing of the pull-tabs 118,120. The
pull-tabs 118,120 enable grasping of the retaining strap 22 and
further include grasping ribs 132 for that purpose. While the
illustrated holes 128 are formed in pull-tabs 118,120, the
principles of the present invention are also applicable where the
holes 128 are formed in another portion of the body 114.
Furthermore, with regard to certain aspects of the present
invention, both or neither pair of tabs 118,120 can be provided
with multiple attachment locations (or even only one tab could be
provided with multiple attachment locations). In addition, the
retaining strap 22 includes recessed scallops 134 between each of
the pull-tabs 118,120.
[0064] As perhaps best shown in FIGS. 5 and 6, the pull-tabs
118,120 and the stretch portion 122 give the retaining strap 22 a
variable thickness. In particular, the pull-tabs 118,120 are about
twice the thickness of the stretch portion 122 with the thickness
tapering therebetween. Thus, the strain varies along the length of
the body 114 so that the stretch portion 122 undergoes more elastic
strain than the tabs 118,120 when a tensile load is applied to the
retaining strap 22. Because strain is proportional to deformation,
the stretch portion 122 will generally elastically elongate more
than the tabs 118,120. While the body 114 is preferably formed of a
substantially homogeneous material, it is also consistent with the
principles of the present invention that the body 114 could include
alternative materials to give the tabs 118,120 a generally greater
modulus of elasticity than the remainder of the body. Such an
alternative construction could involve forming the tabs with a
relatively hard plastic material and the stretch portion 122 with
an elastomer. In that situation, the stretch portion 122 would
again undergo more elastic strain than the tabs 118,120 when a
tensile load is applied. As will be apparent, the greatest degree
of elastic stretching or elongation of the strap 22 occurs within
the central portion 122 during use which facilitates the desired
gripping of the catheter 12 or 16.
[0065] As discussed, the retaining strap 22 includes a
substantially homogeneous material. More preferably, the retaining
strap 22 is molded out of a substantially clear elastomeric
silicon-material. Also, the retaining strap 22 is preferably molded
in an injection molding process. However, it could also be formed
by other molding processes, such as thermoforming, known to those
of ordinary skill in the art.
[0066] The elastomeric silicon material preferably includes a
relatively high coefficient of friction and exhibits some
"stickiness" on at least its catheter-engaging surfaces. Again, the
use of elastomeric materials is preferred for enabling the
intravenous catheter anchoring assembly 10 to frictionally engage
the catheter 16. However, it is also preferred to coat portions of
the elastomer surface of the retaining strap 22 with Parylene so
that it is soft and has a relatively low coefficient of friction.
For example, the outer, non-catheter-engaging surfaces of the
retaining strap 22 are preferably coated so as to be soft and
comfortable to the touch. Again, the Parylene coating is not
preferred for the catheter-gripping surfaces of the illustrated
retaining strap 22.
[0067] Turning to FIGS. 4, 5, and 7, the retaining strap 22 is
initially attached to the platform 20 by preferably receiving two
connectors 92 on one of the platform's sides 110 within respective
pull-tabs 118. The rounded end 106 of post 104 is larger in
diameter than the hole 128. Therefore, the elastic pull-tab 118
stretches outwardly so as to pass over end 106 and then be received
on the post 104. The undersized hole 128 and rounded end 106
further restrict the pull-tab 118 from becoming unintentionally
removed from the attached position. However, the flat 108 permits
easier attachment and removal of the retaining strap 22 when the
retaining strap is in a substantially upright orientation.
[0068] While the illustrated platform 20 includes the post 104 and
the corresponding hole 128 is in the retaining strap 22, the
platform 20 and retaining strap 22 could be variously configured to
achieve a similar connecting mechanism without departing from the
scope of the present invention. For example, either the platform 20
or retaining strap 22 could include one or more engageable posts,
hooks, barbs, balls or other male projections. The other
corresponding platform 20 or retaining strap 22 could then include
corresponding holes, slots, sockets, or other female ends to
achieve a removable connection with the respective male
projections. Alternatively, the platform 20 or retaining strap 22
could each include a combination of male and female connectors
consistent with the scope of the present invention.
[0069] Moreover, it is within the ambit of the present invention
that the platform 20 and retaining strap 22 could be permanently
attached to each other. For example, one or both ends 116 of the
retaining strap 22 could be molded with, over-molded to, adhered
to, or otherwise non-removably (e.g., integrally) fixed to the
platform 20. The term "coupled" as used herein shall be interpreted
to mean permanently attached, as discussed, or removably
attached.
[0070] In the illustrated embodiment, the retaining strap 22 is
fully secured to the platform 20 by lowering the pull-tabs 120
(causing the body 114 to flex) so that the remaining two connectors
92 can be received within two of the holes 128. The upwardly and
outwardly angled posts 104 restrict the retaining strap 22 from
moving out of the attached position, as the strap 22 would have to
be stretched to a greater extent to do so. Again, each of the
pull-tabs 120 includes a plurality of holes 128 for selective
attachment to the connectors 92. Generally, each of the pull-tabs
120 can be attached to its respective connector 92 at the same time
along any one of the holes 128. Thus, the retaining strap 22 is
variously adjustable. Additionally, because the connectors 92 are
about evenly spaced as discussed above, the retaining strap 22 is
attachable to the platform 20 in any of four discrete orientations
relative to the platform 20.
[0071] The elastomeric retaining strap 22 preferably includes a
lower modulus of elasticity than the platform 20, making the
retaining strap 22 less rigid than the platform 20. Therefore, when
the retaining strap 22 is attached between connectors 92 under
tension, the retaining strap 22 elongates while the platform 20
deflects negligibly. In this manner, the platform substantially
retains its shape when the body is elastically stretched to receive
the catheter 16.
[0072] Turning to FIGS. 3-4, the attached retaining strap 22 and
platform 20 form internal passageways 136 for receiving the
catheter 16 so that the proximal and distal sections 38,40 project
outwardly from the catheter anchoring assembly 10. The passageways
136 are defined by internal surfaces that receive and hold the
catheter 16. Specifically, the upper surface 94 of platform 20, the
connectors 92, and the lower surface 126 of retaining strap 22
provide these internal surfaces. Furthermore, the edges of these
surfaces collectively form four discrete catheter-receiving
openings 138. Each of the passageways 136 is defined by a
respective pair of openings 138 and the internal surfaces. However,
it is also consistent with the principles of the present invention
for the passageways 136 to be defined by more than two openings
138. For example, a multi-lumen catheter may extend through three
or more openings. In this manner, the passageways 136, although
occupying the same volume, each provide a discrete path into and
out of the catheter anchoring assembly 10. While the preferred
embodiment includes four openings 138 and associated passageways
136, the principles of the present invention are equally applicable
to including a greater or lesser number of openings 138 which are
preferably and cooperatively defined by the platform 20 and strap
22.
[0073] The passageways 136 are also adjustably sized and shaped due
to the adjustable and elastic features of the retaining strap 22.
More specifically, the passageways 136 have an adjustable
cross-sectional dimension D (see FIG. 4). The illustrated dimension
D is the maximum internal height between the platform 20 and the
retaining strap 22. However, the passageways 136 include other
adjustable cross-sectional dimensions (not shown) between the
retaining strap 22 and the platform 20. The dimension D varies
depending on which of the three holes 128 in pull-tabs 120 receive
the respective connector 92. The dimension D also varies depending
on the size and shape of the received catheter 16.
[0074] The catheter anchoring assembly 10 secures the catheters 12,
16 as shown in FIGS. 1-5. In FIG. 1, the catheter 12 is secured by
arranging the Y-site suture hub 26 between the platform 20 and the
retaining strap 22. In FIGS. 2 and 3, the catheter 16 is aligned
substantially orthogonally to the longitudinal axis of the membrane
18 and platform 20. As discussed, the retaining strap 22 is
partially attached to the platform 20 with connectors 92 being
received in holes 128 of the tabs 118. Most preferably, an edge of
the retaining strap 22 is received within the annular groove 56 to
further restrict axial movement of the catheter 16.
[0075] The pull-tabs 120 are then secured to the remaining
connectors 92 by stretching the retaining strap 22 over the suture
hub 46. The platform 20 and strap 22 are preferably configured and
dimensioned so that the strap 22 is elastically stretched when the
catheter is secured between the platform 20 and strap 22, whereby
the catheter 16 is gripped and axially retained. The suture hub 46
is arranged between the platform 20 and retaining strap 22 with the
tubing 42 extending through oppositely spaced openings 138 and
across the primary attachment sides 110. Furthermore, projections
50 are received respectively in the remaining oppositely spaced
openings 138. Again, the fully attached retaining strap 22 is
preferably elastically elongated and under tension to force the
catheter 16 against the platform 20. This elongation further
promotes the gripping ability of the retaining strap 22 by
increasing the frictional engagement between the retaining strap 22
and catheter 16. Elongation and stretching around the catheter 16
also promotes gripping in that the retaining strap 22 conforms more
closely to the contours of the catheter 16. The illustrated
retaining strap 22 and platform 20 grip the catheter 16 to restrict
movement along the catheter's axial direction but also along a
transverse or vertical direction. Moreover, the catheter 12 is
substantially restricted from rotating in any direction. However,
it is consistent with certain aspects of the present invention that
the retaining strap 22 could be attached to retain the catheter 16
without being elongated or otherwise elastically stretched.
[0076] Referring to FIG. 4, the illustrated catheter 16 is aligned
with the longitudinal axis of the membrane 18 and platform 20 in an
alternative and orthogonal orientation relative to the orientation
of the catheter 16 shown in FIG. 3. Again, the retaining strap 22
is stretched around the suture hub 46 and grips the catheter 16.
The tubing 42 extends through a pair of oppositely spaced openings
138, but across the secondary attachment sides 112. Projections 50
are received in the remaining oppositely spaced openings 138.
Therefore, the catheter 16 is permitted to be secured in any of
four discrete orientations with respect to the platform 20. The
selectable orientations permit the membrane 18 and platform 20 to
be variously arranged on patient P for optimizing the patient's
comfort or the adhering strength between the membrane 18 and the
patient's skin with minimal effect on the desired catheter
orientation.
[0077] In operation, the catheter 16 is inserted into the patient P
(see FIG. 2) and then arranged relative to the patient's arm A.
Although the illustrated catheter 16 is shown in association with
the patient's arm, other peripheral locations (e.g., the leg, foot,
etc.) are entirely within the ambit of the present invention. The
proximal section 26 extends toward and connects to an intravenous
fluid administration set (not shown). The catheter anchoring
assembly 10 is arranged under the catheter 16 in the desired
orientation. Once positioned, the catheter anchoring assembly 10 is
adhered to the patient's skin adjacent to the puncture location 30.
Obviously, one important advantage of the assembly 10 is the
ability to securely fix the catheter 16 to the patient without
requiring the use of sutures, which significantly increase patient
discomfort and the risk of infection. The catheter 16 extends
across the platform 20 with the projections 50 spaced between the
connectors 92. The retaining strap 22 is initially attached to the
platform 20 so that the retaining strap 22 secures the catheter 16
between two of the connectors 92. The retaining strap 22 is then
elastically stretched across the platform 20 and secured to the
remaining connectors 92. Thus, the catheter 16 is secured so that
the tubing 42 is secured in two oppositely spaced openings 138 and
the projections 50 are secured in the other two oppositely spaced
openings 138.
[0078] The elongated pull-tabs 120 can be re-attached to the
connectors 92 to change the amount of elastic elongation in the
retaining strap. In this manner, the catheter 16 can be more
tightly or loosely secured. Such reattachment not only permits the
catheter-receiving passageway to be adjustably sizeable, but with
the elastic nature and stretching of the strap 22, the gripping
force applied against the catheter 16 can be varied. The pull-tabs
118,120 can be released to permit removal of the catheter 16 from
the catheter anchoring assembly 10.
[0079] Turning to FIGS. 8-26, alternative embodiments of the
present invention are depicted. For the sake of brevity, the
remaining description will focus primarily on the differences of
these alternative embodiments from the preferred embodiment.
[0080] FIGS. 8-9 illustrate two alternative embodiments of the
present invention. These alternative embodiments are directed to
alternative platforms having an alternatively shaped base as will
be discussed.
[0081] In FIG. 8, a second embodiment of the present invention is
an intravenous catheter anchoring assembly 200 including an
alternative platform 202. The platform 202 includes a base 204
presenting an upper surface 206 and connectors 208. The base 204
further includes rib-like protrusions 210 forming part of the upper
surface 206. The protrusions 210 are parallel to each other and
extend between primary attachment sides 212 of the platform 202 for
securing the catheter (not shown) therebetween. The protrusions 210
are preferably molded with the rest of the base 204, but could
alternatively be machined or separately formed and then attached
without departing from the principles of the present invention.
[0082] In FIG. 9, a third embodiment of the present invention is an
intravenous catheter anchoring assembly 300 including an
alternative platform 302. The platform 302 includes a base 304
presenting an upper surface 306 and connectors 308. The base 304
further includes a concave depression 310 defining a curvilinear
portion of the upper surface 306. The shape of the depression 310
is preferably configured to receive the catheter hub (not shown).
While the illustrated depression 310 is shaped to receive a variety
of catheter hubs, the depression 310 could be alternatively shaped
to receive a particular catheter hub so that the depression 310 is
form-fitting. The depression 310 is preferably molded with the rest
of the base 304 but could also be machined or separately formed and
then attached to the upper surface 306.
[0083] FIGS. 10-14 illustrate several alternative embodiments of
the present invention. These alternative embodiments are directed
to anchoring assemblies incorporating alternative retaining
straps.
[0084] In FIG. 10, a fourth embodiment of the present invention is
an intravenous catheter anchoring assembly 400 including an
alternative retaining strap 402. The retaining strap 402 comprises
a body 404 including pull-tabs 406 and presenting upper and lower
surfaces 408,410. The body 404 further includes a spherical
protrusion 412 forming part of the lower surface 410. The
protrusion 412 is shaped to press against the catheter hub (not
shown) when the retaining strap 402 is coupled to the platform (not
shown). The protrusion 412 is preferably compressible to the extent
that it is compressed during use of the assembly 400, whereby
gripping of the catheter is further enhanced.
[0085] In FIG. 11, a fifth embodiment of the present invention is
an intravenous catheter anchoring assembly 500 including an
alternative retaining strap 502. The retaining strap 502 comprises
a body 504 including pull-tabs 506 and presenting upper and lower
surfaces 508,510. The body 504 further includes rib-shaped
protrusions 512 that are parallel to each other. The protrusions
512 form part of the lower surface 510 for receiving the catheter
(not shown). Moreover, the protrusions 512 preferably function
similar to the protrusion 412 shown in FIG. 10.
[0086] In FIG. 12, a sixth embodiment of the present invention is
an intravenous catheter anchoring assembly 600 including an
alternative retaining strap 602 and a platform 604. The retaining
strap 602 comprises a body 606 including pull-tabs 608. The body
606 has a generally H-shaped configuration with all of the
pull-tabs 608 being generally elongated. The retaining strap 602
cooperates with the platform 604 to form a first pair of
substantially identical catheter-receiving openings 610 and a
generally transverse second pair of substantially identical
catheter-receiving openings 612. A catheter 614 includes a catheter
hub 616 with a body 618 and projections 620. The illustrated
openings 610,612 receive ends of the body 618 and projections 620
respectively. However, the openings 610,612 permit the catheter 614
to be secured in one of four discrete orientations.
[0087] In FIG. 13, a seventh embodiment of the present invention
comprises an intravenous catheter anchoring assembly 700 including
an alternative retaining strap 702 and a platform 704. The
retaining strap 702 comprises a body 706 including pull-tabs
708,710. The body 706 has a generally U-shaped configuration. The
retaining strap 702 cooperates with the platform 704 to provide
openings 712 and corresponding passageways through which a catheter
714 is received.
[0088] In FIGS. 14a and 14b, an eighth embodiment of the present
invention is an intravenous catheter anchoring assembly 800
including an alternative retaining strap 802 and platform 804. The
retaining strap 802 includes non-unitary strap portions 806, where
each of the elongated portions 806 comprises a body 808 including
pull-tabs 810. As depicted in FIG. 14a, the portions 806 are
attached to the platform 804 in a substantially parallel
relationship so that four catheter-receiving openings 812 are
formed between the, platform 804 and retaining strap 802, each
opening extending along a corresponding side of one of the strap
portions 806. The strap portions 806 essentially define two
passageways, with the catheter 814 preferably being received in
both passageways simultaneously. The catheter 814 includes wings
816 that are not received in the passageways. As depicted in FIG.
14b, the portions 806 are attached to the platform 804 in a
crossing (X-shaped) relationship so that four catheter-receiving
openings 812 are formed and define a plurality of passageways. The
openings 812 are generally V-shaped in plan view. The catheter 814
and catheter wings 816 are received within the passageways.
[0089] FIGS. 15-20 illustrate several alternative embodiments of
the present invention. These embodiments are directed to
alternative platform and retaining strap combinations.
[0090] Referring to FIGS. 15 and 16, a ninth embodiment of the
present invention is an intravenous catheter anchoring assembly 900
including an alternative platform 902 and an alternative retaining
strap 904. The platform 902 includes a base 906, connectors
908,910, and pin 912. The base 906 is flat and generally
rectangular-shaped with straight edges 914 and scalloped edges 916.
Along one of the straight edges 914, connectors 908 extend out and
include a post 918 with a spherical end 920. The post 918 is curved
and extends upwardly and outwardly from the base 906. Along the
other straight edge 914, connectors 910 extend laterally out from
the base 906 and include aligned holes 922. The holes 922 rotatably
receive the pin 912.
[0091] The U-shaped retaining strap 904 includes a body 924
presenting an attachment end 926 and pull-tabs 928. The attachment
end 926 includes a bore 930 that receives the pin 912. In this
manner, the retaining strap 904 and platform 902 are partially
attached to each other by a hinge. The pin 912 is preferably
rotates relative to the retaining strap 904 when the strap 904 and
platform 902 are assembled. However, it is also consistent with the
principles of the present invention for the pin 912 to rotate
relative to either or both the strap 904 and platform 902. The
retaining strap 904 is further attached to the platform 902 by
securing the connectors 908 within respective holes 932 of the
pull-tabs 928. Although not shown, each of the tabs 928 can be
provided with multiple holes 932 to afford the adjustability noted
above.
[0092] Referring to FIGS. 17 and 18, a tenth embodiment of the
present invention concerns an intravenous catheter anchoring
assembly 1000 including an alternative platform 1002 and an
alternative retaining strap 1004. The platform 1002 includes a base
1006 and connectors 1008, 1010. Connectors 1008 include recessed
hooks 1012 projecting laterally from the base 1006 and turning
downward. Connectors 1010 project upwardly and outwardly from the
base 1006 and include a post 1014 with an enlarged spherical head
1016. The U-shaped retaining strap 1004 comprises a body 1018
presenting an attachment end 1020 and pull-tabs 1022. The
attachment end 1020 includes slotted holes 1024 that each receive a
respective one of the hooks 1012. Each pull-tab 1022 includes a
pair of rounded holes 1026 that are undersized relative to the
spherical head 1016.
[0093] Turning to FIGS. 19 and 20, an eleventh embodiment of the
present invention comprises an intravenous catheter anchoring
assembly 1100 including an alternative platform 1102 and an
alternative retaining strap 1104, which are similar to that shown
in FIGS. 17 and 18. The platform 1102 includes a base 1106 and
connectors 1108, 1110. Connectors 1108 include recessed hooks 1112
projecting laterally from the base 1106. Connectors 1110 project
upwardly and outwardly from the base 1106 and include a post 1114
having a rectangular cross-section. The rectangular-shaped
retaining strap 1104 comprises a body 1116 including an attachment
end 1118 and a single pull-tab 1120. The attachment end 1118 and
pull-tab 1120 include slotted holes 1122 that each receive a
respective one of the connectors 1110. The body 1116 is generally
solid and rectangular in shape, such that discrete pull-tabs are
not defined.
[0094] FIGS. 21-24 illustrate two alternative embodiments of the
present invention. These embodiments principally perform the
function of a tubing collector, but they also have features which
restrict axial movement of the tubing, such that they might also
serve as site securement devices.
[0095] In FIGS. 21 and 22, a twelfth embodiment of the present
invention concerns an intravenous catheter anchoring assembly 1200
including an alternative platform 1202 and an alternative retaining
strap 1204. The platform 1202 includes an elongated base 1206 with
ends 1208. The platform 1202 further includes connectors 1210
extending from the ends 1208. Between the ends 1208 are arcuate
troughs 1212 that have a semi-circular cross-section. The troughs
1212 are substantially parallel and are separated by ridges 1214.
The arcuate troughs 1212 run orthogonally to the longitudinal axis
of the base 1206. The troughs 1212 and ridges 1214 form part of an
upper surface 1216 that provides discrete locations for receiving
tubing 1218 (see FIG. 21). The illustrated tubing 1218 is part of
an intravenous administration set 1220. However, it is consistent
with the principles of the present invention that the tubing 1218
could be part of an extension set or could be catheter tubing.
[0096] The retaining strap 1204 comprises a body 1222 with pull
tabs 1224, a stretch portion 1226, and through-holes 1228. The
tubing 1218 is preferably arranged in a serpentine pattern such
that each trough 1212 receives a section of the tubing 1218. The
strap 1204 is then stretched over the arranged tubing 1218 to hold
the tubing 1218 within the troughs 1212 and thereby restrict
movement out of the troughs 1212 and axial movement through the
troughs 1212.
[0097] In FIGS. 23 and 24, a thirteenth embodiment of the present
invention comprises an intravenous catheter anchoring assembly 1300
including an alternative platform 1302 and a retaining strap 1304,
which are similar to that shown in FIGS. 21 and 22. The platform
1302 includes a base 1306 with ends 1308. Between the ends 1308 are
arcuate troughs 1310 separated by ridges 1312. The troughs 1310
each have a substantially semi-circular cross-section (preferably
defined by an arc of about 180.degree.) and include a maximum
width. However, the principles of the present invention are equally
applicable to a trough cross-section that is smaller or larger than
180.degree.. A longitudinal ridge 1314 runs between the ends 1308
and over the ridges 1312 to form catches 1316 on each side of each
trough 1310 that project radially inward relative to the arc.
[0098] The illustrated catches 1316 cooperate with the troughs 1310
to define undercut sides and restricted openings 1318 that are
smaller in width than the trough's maximum width and undersized
relative to the diameter of tubing 1320 (see FIG. 24). In this
manner, the troughs 1310, ridges 1312, and catches 1316 form an
upper surface 1322 of the platform 1302 for receiving catheter
tubing 1320 and releasably retaining the tubing 1320 within the
troughs 1310. In particular, the catches 1316 permit various sizes
of tubing 1320 to be partially secured in the catheter anchoring
assembly 1300 prior to completed attachment of the retaining strap
1304. This enables the patient to single-handedly secure the tubing
1320 by attaching the retaining strap 1304 without having to
simultaneously hold the tubing 1320 in place. In essence the tubing
1320 is "snapped" into the troughs 1310 with the catches 1316
slightly deforming the tubing 1320 and thereby gripping it in
place. Such gripping further restricts axial movement of the
tubing. The principles of the present invention are also applicable
to other trough shapes that provide restricted openings, such as a
trough cross-section with a circular arc of greater than
180.degree. or a non-circular shape with an opening smaller than
its maximum width.
[0099] The platform 1302 further includes a lower surface 1324. The
base 1306 includes a plurality of parallel grooves 1326 extending
between sides of the platform 1302. The grooves 1326 have undercut
sides 1328 (similar to a dove-tail cross-section) to form a narrow
opening 1330 and a slightly wider base 1332. The grooves 1326
increase the base's surface area to promote adhesion to the
flexible membrane (not shown). The shape of the grooves 1326 also
permit adhesive to be received therein such that the adhesive layer
is mechanically and adhesively attached to the platform 1302.
[0100] In FIGS. 25 and 26, a fourteenth embodiment of the present
invention comprises an intravenous catheter site securement device
1400 specifically designed for securing the alternative catheter
44. The catheter anchoring assembly 1400 includes an alterative
platform 1402 and a retaining strap 1404. The platform 1402
includes a base 1406 with ends 1408. The base includes, between the
ends 1408, an arcuate trough 1410, spaced apart ridges 1412, and a
stop 1414 located at one end of the trough 1410. The base 1406
includes an upper surface 1416. The trough 1410 forms an inclined
section 1418 of the upper surface 1416.
[0101] The platform 1402 and retaining strap 1404 receive the
catheter hub 48 and secure it within the trough 1410 so that it is
inclined toward the stop 1416. In this mariner, the strap which is
preferably elastically stretched urges the hub 48 against the
inclined trough 1410 downwardly toward and against the stop 1416.
Thus, the stop 1416 resists axial movement of the catheter 44
beyond the stop 1416, and the inclined trough resists axial
movement of the catheter 44 away from the stop 1416. The restricted
axial movement also restricts pistoning of the catheter 44.
[0102] FIGS. 27-28 illustrate a fifteenth embodiment of the present
invention. The alternative embodiment functions primarily as an
intravenous site securement device. However, the principles of this
embodiment are equally applicable to other intravenous anchoring
devices such as tubing collectors.
[0103] In FIG. 27, an intravenous catheter anchoring assembly 1500
includes a platform 1502, a patient-contacting membrane 1504, and
an alternative retaining strap 1506 for securing the catheter 1508
(see FIG. 28). The platform 1502 includes a base 1510 and
connectors 1512 and further presents an upper surface 1514. The
connectors 1512 include a post 1516 with a head end 1518.
[0104] The retaining strap 1506 includes a body 1520. The body 1520
includes attachment ends 1522 with pull-tabs 1524, 1526. The body
1520 further includes a centrally located stretch portion 1528
between the ends 1522 and presents upper and lower surfaces 1530,
1532. The body 1520 also includes attachment locations with
through-holes 1534 and reinforced ribs 1536 surrounding the holes
1534. Pull-tabs 1524 each include a single hole 1534, and pull-tabs
1526 each include two holes 1534 for adjustment purposes. The ribs
1536 extend from the upper surface 1530 and include a deflecting
surface 1538 that tapers inwardly as it extends from the upper
surface 1530. Thus, the deflecting surface 1538 forms a conical
frustum (i.e., has a frusto-conical shape). The ribs 1536 are also
shaped to provide a countersunk portion 1540 of the holes 1534.
[0105] The retaining strap 1506 is attached to the platform 1502 by
extending the posts 1516 through respective holes 1534. As
discussed, pull-tabs 1526 each include two holes 1534 so that the
retaining strap 1506 may be adjustably positioned relative to the
platform 1502. The countersunk portion 1540 permits the head end
1518 to be received therein without stretching the ribs 1536
outward. The deflecting surface 1538 extends inward with the
uppermost end surrounding the head end 1518. Thus, the deflecting
surface 1538 reduces the risk of catching or snagging of external
objects (e.g., clothing) by inadvertent contact with the ribs 1536
or connectors 1512. The principles of the present invention are
applicable to raised ribs with alternative shapes that guard
against accidental snagging of the anchoring assembly 1500.
[0106] The preferred forms of the invention described above are to
be used as illustration only, and should not be utilized in a
limiting sense in interpreting the scope of the present invention.
Obvious modifications to the exemplary embodiments, as hereinabove
set forth, could be readily made by those skilled in the art
without departing from the spirit of the present invention.
[0107] The inventors hereby state their intent to rely on the
Doctrine of Equivalents to determine and assess the reasonably fair
scope of the present invention as pertains to any apparatus not
materially departing from but outside the literal scope of the
invention as set forth in the following claims.
* * * * *