U.S. patent application number 13/184218 was filed with the patent office on 2012-02-23 for unitary strain-relieving intravenous (iv) anchor system.
This patent application is currently assigned to FastTrack Medical Solutions LLC. Invention is credited to Steven Brinkman, Kim Jacobsen, William Scheremet.
Application Number | 20120046612 13/184218 |
Document ID | / |
Family ID | 45497389 |
Filed Date | 2012-02-23 |
United States Patent
Application |
20120046612 |
Kind Code |
A1 |
Scheremet; William ; et
al. |
February 23, 2012 |
Unitary Strain-Relieving Intravenous (IV) Anchor System
Abstract
A system for strain relieving intravenous (IV) assembly includes
a dressing and an anchor portion for use with the dressing. In
various embodiments, the dressing may cover an injection site into
a portion of a patient's body for an intravenous (IV) assembly that
provides fluid communication between the injection site and a fluid
reservoir remote from the injection site through a flexible tube.
In an illustrative example, the anchor portion may include a first
member and a second member. The first member may be secured, for
example, to the dressing and may, in some examples, wrap around the
tubing so as to resist axial movement of the tubing relative to the
dressing. The second member may be secured to the dressing and may
wrap around the tubing and a portion of the patient's body so as to
resist radial movement of the tubing relative to the body.
Inventors: |
Scheremet; William;
(Hinkley, MN) ; Brinkman; Steven; (Eden Prairie,
MN) ; Jacobsen; Kim; (Minneapolis, MN) |
Assignee: |
FastTrack Medical Solutions
LLC
Eden Prairie
MN
|
Family ID: |
45497389 |
Appl. No.: |
13/184218 |
Filed: |
July 15, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61365351 |
Jul 18, 2010 |
|
|
|
Current U.S.
Class: |
604/179 |
Current CPC
Class: |
A61M 2025/0246 20130101;
A61M 5/158 20130101; A61M 2005/1586 20130101; A61M 25/02 20130101;
A61M 2025/026 20130101 |
Class at
Publication: |
604/179 |
International
Class: |
A61M 39/00 20060101
A61M039/00 |
Claims
1. An apparatus comprising: a dressing adapted to cover an
injection site into a portion of a patient's body part for an
intravenous (IV) assembly that provides fluid communication between
the injection site and a fluid reservoir remote from the injection
site through a length of flexible IV tubing; a first member secured
to the dressing and adapted to wrap around the tubing so as to
resist axial movement of the tubing relative to the dressing; and,
a second member secured to the dressing and adapted to wrap around
the tubing and the body part so as to maintain the tubing in close
proximity to the body part.
2. The apparatus of claim 1, wherein the second member comprises a
strip of hook and loop fastener for attaching the loose end of the
second member to itself after wrapping around the portion of the
patient's body.
3. The apparatus of claim 1, wherein the first member comprises an
adhesive for adhering to the IV tubing on the portion of the
patient's body.
4. The apparatus of claim 3, wherein the adhesive comprises a
hydrogel.
5. The apparatus of claim 1, wherein the dressing further comprises
an anti-microbial substance.
6. The apparatus of claim 1, wherein the first member comprises a
material of high coefficient of friction.
7. The apparatus of claim 1, wherein a surface of the first member
provides substantial friction when in contact with the tubing.
8. The apparatus of claim 1, wherein the first member is secured to
the dressing near an edge of the dressing.
9. The apparatus of claim 1, wherein the second member and the
first member are secured to the dressing on an opposite edges of
the dressing.
10. The apparatus of claim 1, wherein the second member comprises a
hook and loop fastener.
11. The apparatus of claim 1, wherein the second member further
resists axial forces.
12. An apparatus comprising: a dressing adapted to cover an
injection site into a portion of a patient's body for an
intravenous (IV) assembly that provides fluid communication between
the injection site and a fluid reservoir remote from the injection
site through a length of flexible tubing; means for relieving the
tubing against radial forces applied substantially perpendicular to
the surface of the skin on the portion of the patient's body; and
means for relieving the tubing against axial forces applied
substantially parallel to the surface of the skin on the portion of
the patient's body.
13. The apparatus of claim 12, wherein the radial forces are
applied substantially perpendicular and the axial forces are
applied substantially parallel to the surface of the skin on the
portion of the patient's body at a perimeter of the dressing.
14. The apparatus of claim 12, wherein the radial and axial forces
on the tubing are substantially attenuated at the injection
site.
15. The apparatus of claim 12, wherein the means for relieving the
tubing against radial forces further relieves the tubing against
axial forces.
16. A method of using an apparatus, the method comprising:
positioning a dressing over an injection site into a portion of a
patient's body for an intravenous (IV) assembly that provides fluid
communication between the injection site and a fluid reservoir
remote from the injection site through a length of flexible IV
tubing; wrapping a first member around the tubing so as to resist
axial movement of the tubing relative to the dressing; and wrapping
a second member around the tubing and the body so as to maintain
the tubing in close proximity to the portion of the patient's
body.
17. The method of claim 16, wherein wrapping the second member
comprises attaching a loose end of the second member to itself
18. The method of claim 16, wherein wrapping the first member
comprises attaching a loose end of the first member to itself
19. The method of claim 16, wherein the second member is wrapped
around the first member that is positioned around the tubing.
20. The method of claim 16, wherein the second member resists both
axial and radial forces movement of the tubing relative to the
dressing.
Description
[0001] This application claims the benefit of U.S. Provisional
Patent Application entitled "Unitary Strain-Relieving Intravenous
(IV) Anchor," Ser. No. 61/365,351, which was filed by Scheremet, et
al. on Jul. 18, 2010, the entire contents of which are incorporated
herein by reference.
TECHNICAL FIELD
[0002] Various embodiments relate to providing strain relief to
intravenous (IV) lines.
BACKGROUND
[0003] In intravenous (IV) therapy, liquid substances are
administered directly into a vein. The term "intravenous" generally
means "within a vein." Compared with other routes of
administration, the intravenous route is probably the fastest way
to deliver liquids throughout a body. Some medications, blood
transfusions, and parenteral nutrition can only be administered
intravenously.
SUMMARY
[0004] Certain embodiments of an IV anchor may achieve one or more
advantages. For example, some embodiments may protect an IV
injection site by providing strain relief to an IV injection site.
In an illustrative example, certain embodiments may provide a
breathable transparent window for monitoring of a junction that
connects the catheter-and-hub assembly to a saline cap, IV tubing
extension set, or full IV tubing. In some implementations, the IV
junction and the injection site on the patient's body may be
substantially protected from contamination by an exemplary
dressing. In some examples, the dressing may be coated with an
adhesive (e.g., hydrogel) mixed with an anti-microbial substance.
Various examples may facilitate organization of the components of
an IV line relative to each other and/or relative to other tubes or
cords connected to a patient.
[0005] The details of various embodiments are set forth in the
accompanying drawings and the description below. Other features and
advantages will be apparent from the description and drawings, and
from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 shows a perspective view of an exemplary intravenous
(IV) anchor system.
[0007] FIGS. 2, 3A, and 3B show perspective views of components of
an exemplary IV line for administering IV therapy.
[0008] FIGS. 4-9 show perspective views of an exemplary process of
assembling the anchor system of FIG. 1 to the IV line of FIG.
3.
[0009] FIGS. 10 and 11 show a perspective view of the anchor
illustrating how the anchor provides strain relief to the IV line
of FIG. 3.
[0010] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0011] FIG. 1 shows a perspective view of an exemplary intravenous
(IV) anchor system. In the depicted example, an IV anchor system
100 is configured as a unitary device that, for example, may
substantially protect an IV injection site from contamination. Some
embodiments may provide substantial protection from injury to the
patient and/or disruption of the IV assembly by strain relieving an
IV connection assembly, or "IV line," connected to a
cathether-and-hub assembly and to the injection site. Such strain
relief may resist substantial axial and/or radial force components
applied to the IV line (e.g., during transfer of a trauma patient
from an ambulance or helicopter upon arrival at a hospital).
[0012] By way of example, and not limitation, the IV tubing
assembly that connects to the catheter-and-hub assembly may include
a saline cap, IV tubing extension set, and/or full length IV
tubing.
[0013] The anchor system 100 is a unitary dressing apparatus formed
from a first sheet of material 105, a second sheet of material 115
connected to the first sheet of material 105, and a fastening
device 120 connected to the second sheet of material 115. The first
sheet of material 105 includes a window 110 to allow viewing of the
injection site and junction where the catheter-and-hub assembly
connects with an IV connection assembly. The window 110 may be
formed of plastic.
[0014] The first sheet of material 105 may include an adhesive for
retaining the catheter-and-hub assembly against a body. A second
sheet of material 115 may include an adhesive for retaining the
tubing at a certain position relative to the catheter-and-hub
assembly. The adhesive of the first and second sheets of material
may be the same or different, and the adhesive of either or both of
the first and second sheets of material may contain an
antimicrobial substance. The first and second sheets of material
105, 115 are substantially rectangular in shape. In some
embodiments, either or both of the sheets of material 105, 115 may
be made of fabric alone or in combination with other materials
(e.g., plastic). The fastening device 120 may include a hook and
loop fastener for releasably securing to itself or to another part
of the anchor after being wrapped around a portion (e.g., limb,
torso) of the patient's body.
[0015] FIGS. 2 and 3 show perspective views of components of an
exemplary IV line for administering IV therapy. FIG. 2 shows a
perspective view of an exemplary access device for administering IV
therapy. The access device 200 includes a stylet 205 inside a
catheter (not shown), a connecting hub 210, and a flash chamber
215. The flash chamber and the needle may be one-piece. The flash
chamber may allow observation of blood flow as an indication that
the stylet has been inserted into the vein. When a care giver
withdraws the stylet from the catheter, the stylet may be locked
within the flash chamber to prevent accidental puncture of the care
giver.
[0016] FIGS. 3A and 3B show a perspective view of an exemplary IV
line with tubing connected to the catheter-and-hub assembly of the
access device of FIG. 2. The IV line 300 includes the catheter 205
and the hub 210 of the access device 200 and tubing 320. The flash
chamber 215 may be removed after successful introduction of the
stylet 205 into the vein of the body and replaced by tubing 320 to
establish the IV line 300. When the tubing 320 is connected with
the catheter-and-hub assembly 205, 210, a junction 310 is formed
between the tubing 320 and the hub 210.
[0017] FIGS. 4-9 show perspective views of an exemplary process of
assembling the anchor system of FIG. 1 to the IV line of FIG. 3.
FIG. 4 shows a perspective view of a step 400 of securing the IV
line as shown in FIG. 3 against a portion of a patient's body
(e.g., arm, leg, torso) using the first sheet of material 105 of
the system 100 of FIG. 1. In an exemplary step, with the IV tubing
320 in place, the first sheet of material 105 is positioned around
the injection site and the junction 310 to secure the IV line
against the body. In this example, the first sheet of material 105
is positioned such that the window 110 surrounds the site of
junction 310. The first sheet of material 105 provides a volume
that may substantially protect the site of the junction 310 against
ingress of contaminants or infection.
[0018] FIGS. 5-7 show a perspective view of a step of securing the
tubing relative to the catheter-and-hub assembly of the IV line as
shown in FIG. 3 using the second sheet of material 115 of the
anchor as shown in FIG. 1. In the depicted FIGS. 5-7 at step 500,
the step may include using the second sheet 115 to secure a portion
of the tubing 320 at the point of securement by the second sheet
115 against significant axial movement of the tubing relative to
the catheter-and-hub assembly of the IV line. FIGS. 5-7 show an
exemplary progression of securing the second sheet 115 to the
tubing. The second sheet of material 115 is secured around the
tubing 320 with the opposing ends of the second sheet of material
115 secured to each other. In some implementations, the second
sheet of material 115 may be adhesively coupled directly to the
tubing alone or in conjunction with a secure coupling to itself. In
some examples, the adhesive bond between the second sheet of
material 115 and the tubing may be substantially permanent (e.g.,
not releasable). The second sheet of material 115 may
advantageously locate the IV tubing 320 relative to the
catheter-and-hub assembly to prevent disconnection of the tubing
from the catheter-and-hub assembly.
[0019] FIGS. 8 and 9 show a perspective view of a step of securing
the fastening device 120, as described with reference to FIG. 1,
around a patient's limb to secure the site of junction between the
catheter-and-hub assembly and tubing. In the depicted FIGS. 8 and 9
at step 600, the step may include using the fastening device 120 to
secure a portion of the tubing against significant radial movement
of the tubing relative to the catheter-and-hub assembly of the IV
tubing 320. FIGS. 8 and 9 show the progression of securing the
fastening device 120. In the depicted examples, the fastening
device 120 is positioned around the patient's limb and releasably
attached to itself.
[0020] FIGS. 10 and 11 show a perspective view of the exemplary
anchor system illustrating how the anchor provides strain relief to
the site of junction 310 between the tubing and the
catheter-and-hub assembly. The anchor system 100 provides strain
relief by absorbing forces exerted on the IV tubing 320 and
preventing dislodging of the catheter out of the vein. In some
embodiments the strain relief may also prevent disconnection of the
catheter-and-hub assembly from the tubing 320.
[0021] FIG. 10 shows a perspective view of the anchor adapted to
absorb radial forces exerted on the IV line tubing 320. When the IV
tubing 320 is pulled radially relative to the patient's limb, the
fastening device 120 absorbs the radial pulling force and reduces
the radial pulling force on the junction 310. Such radial strain
relief may advantageously substantially mitigate or prevent
dislodging of the catheter out the vein. In some embodiments, the
strain relief also prevents disconnection of the tubing from the
catheter-and-hub assembly (e.g., due to inadvertent snags on the
tubing 320).
[0022] FIG. 11 shows a perspective view of the anchor system 100
absorbing axial forces exerted on the IV line tubing 320. When the
tubing is pulled axially relative to the patient's limb, the second
sheet of material 115 may advantageously absorb substantially all
axial pulling forces (e.g., up to a stiction force threshold
depending on material interfaces and applied pressure). Such axial
strain relief may advantageously mitigate and/or substantially
prevent axial pulling force on the junction 310 to prevent
dislodging of the catheter from the vein. Accordingly, embodiments
of the anchor system 100 may advantageously reduce incidences of
disconnection of the tubing from the catheter-and-hub assembly,
and/or undesirable forces (e.g., torques) on the injection site
itself, which could lead to injury of the patient or fault in the
intravenous connection, for example.
[0023] Although various embodiments have been described with
reference to the drawings, other embodiments are possible. For
example, with reference to FIG. 1, the first sheet of material 105
may be a dressing adapted to cover an injection site into a portion
of a patient's body for an intravenous assembly that provides fluid
communication between the injection site and a fluid reservoir
remote from the injection site through a length of flexible tubing.
The second sheet of material 115 and the fastening device 120 may
be adapted to cooperate to substantially absorb and/or relieve the
strain at the injection site against forces on the tubing in any
direction relative to the dressing sheet of material 105.
[0024] In an illustrative example, the second sheet of material 115
may be securely attached to the first sheet of material 105, and is
flexibly adapted to wrap around IV tubing so as to resist axial or
sliding movement of the tubing relative to the first sheet of
material 105. The second sheet of material 115 is securely attached
to the first sheet of material 105 at or near an edge of the first
sheet of material 105, for example. The second sheet of material
115 may advantageously relieve the tubing against axial forces
applied substantially parallel to the surface of the skin on the
portion of the patient's body at a perimeter of the first sheet of
material 105, such that the axial forces are attenuated at the
injection site, by absorbing the axial forces. The second sheet of
material 115 increases the axial forces required to disrupt or
disconnect the injection site or the junction between catheter and
hub.
[0025] In some embodiments, the second sheet of material 115 may
include an adhesive to adhere the second sheet of material 115 to
the tubing and opposing ends of the second sheet of material to
tightly envelop and engage the tubing within the second sheet of
material 115.
[0026] In an illustrative example, a portion of the second sheet of
material 115 that directly contacts the tubing may be made, for
example, from a material of high coefficient of friction. Examples
of such materials may include, but are not limited to, rubber or
flannel. In response to the pressure from the fastening device 120,
the high coefficient of friction material may engage the surface of
the tubing to substantially increase a static friction force or a
threshold force along the axis of the tubing that would result in a
sliding of the tube relative to the second sheet of material
120.
[0027] In some embodiments, the portion of the second sheet of
material 115 that directly contacts the tubing may include an
additional layer of material of high coefficient of friction to
increase the friction between the second sheet of material and the
tubing when they are in contact, such that the friction acts to
grip the tubing within the first sheet of material.
[0028] In some implementations, the material with a high
coefficient of friction may be textured to increase grip on the
tubing to prevent sliding in response to axial forces. In some
implementations, friction may substantially increase the force
necessary to disrupt the injection site or junction or attenuates
the force at the injection site or junction that is applied at the
tubing.
[0029] Referring for example to FIG. 10, for example, the fastening
device 120 may be secured to the first sheet of material 105 and
adapted to wrap around the tubing 320 which is wrapped within the
first sheet of material 105 against the portion of the patient's
body so as to resist radial movement of the tubing relative to the
first sheet of material 105. In some implementations, the fastening
device 120 may advantageously substantially resist radial movement
of the tubing relative to the body at the dressing sheet of
material 105. By way of example, and not limitation, the fastening
device 120 may be secured to the first sheet of material 105 near
the edge where the first sheet of material 105 is connected with
the second sheet of material 115. The fastening device 120 may
substantially relieve the tubing against radial forces applied
substantially perpendicular to the surface of the skin on the
portion of the patient's body near a perimeter of the first sheet
of material 105. The fastening device 120 may absorb at least a
threshold amount of applied radial forces, such that the radial
forces are attenuated at the injection site. The fastening device
120 may, in various implementations, substantially increase the
radial forces required to disrupt or disconnect the injection site
or the junction between catheter and hub. By wrapping around the
first sheet of material 105 that encloses the tubing, the fastening
device 120 also reinforces the strain relief of the tubing 320 from
axial forces.
[0030] With reference to FIG. 6, the first sheet of material 115
may, in some examples, fold back onto itself around the tubing. In
some implementations, after enclosing the tubing within the first
sheet of material 115, the loose ends of the first sheet of
material 115 may also be folded over the tubing or adhered to a
patient's skin. With reference to FIG. 9, the fastening device 120
may be wrapped around a portion of the patient one or more times.
The loose end may be releasably attached to the fastening device
120 itself In some examples, the loose end of the fastening device
120 may be secured to the dressing sheet of material 105 and/or the
first sheet of material 115.
[0031] In various embodiments, either or both of the first and
second sheets of material 105, 115 and/or the fastening device 120
may be in various lengths or shapes, such as circular or
elliptical, to accommodate different size patients, and/or
different shape sites (e.g., torso, trunk, arms, leg, neck, wrist,
hand, foot, head).
[0032] In some embodiments, the adhering ability of the first and
second sheets of material 105, 115, or the fastening device 120 may
be enhanced through attachment mechanisms in addition to or other
than an adhesive. By way of example and not limitation, attachment
mechanisms for securing may include devices such as a clamp, clip,
or snap fastener, for example. In some embodiments, the adhesive
may be exposed upon removal of a peel away release liner (e.g.,
backing) The second sheet 115 and the fastening device 120 may be
configured for self-fastening, for example, the second sheet 115
and the fastening device 120 may each have one or more slits for
mating with their loose ends. In some implementations, the loose
end may be shaped for fastening with a slit. For example, a portion
of the insertion end of the loose end may have an increased
diameter to prevent disconnection with the slit. In some
embodiments, the slit may be smaller than the insertion end of the
loose end. In some implementations, the loose end may include a
slit that cooperates with a slit on the respective second sheet 115
or fastening device 120.
[0033] The window 110 may be formed in some implementations as a
resilient, breathable transparent plastic film. The window 110 may
be an opening in the first sheet of material formed from a porous
material to allow airflow into the site of connection between the
catheter-and-hub assembly and tubing while still providing
protection against contamination. In some examples, the window 110
may include a fabric material layer, which may be provided alone or
in combination with another material such as an exterior breathable
transparent plastic layer. The second sheet of material 115 may be
formed by separation at perforations in the first sheet of material
105 or by being pre-cut from the first sheet of material 105. In
some implementations, the sheets of material 105, 115 may be
secured together by sewing, for example. The first sheet of
material 105, second sheet of material 115, and the fastening
device 120 may be formed from separate components and attached
together. In some implementations, the second sheet of material 115
and the fastening device 120 may each be formed from different
materials and attached at the perimeter of the first sheet of
material 105 by various attachment means including but not limited
to sewing, adhering, or stapling. In some implementations, the
second sheet of material 115 and the fastening device 120 are
attached onto the surface of the first sheet of material 105. A
partial cut may be made along the perimeter of the second sheet of
material 115 and the fastening device 120 next to the first sheet
of material so the second sheet of material 115 and the fastening
device 120 remain attached to the first sheet of material 105. In
some embodiments, the fastening device 120 may be attached to the
second sheet of material 115. In some implementations, the second
sheet of material 115 and the fastening device 120 may be formed
from a single material to form a unitary strip and attached to the
first sheet of material 105. One end of the unitary strip may act
as the second sheet of material 115 that directly contacts the
tubing, and the other end may act as the fastening device 120 that
wraps around the portion of the patient's body back onto itself. In
some examples, the end that acts as the fastening device 120 may be
longer than the end that acts as the second sheet of material
115.
[0034] In some examples, the fastening device 120 may be formed
from a hook and loop-type fastener, for example. In some examples,
the fastening device may provide a secure attachment after wrapping
around the patient's body part. By way of example and not
limitation, the fastening device may include attachment means such
as one or more clamps, clips, buttons inserted within a slit, snap
buttons, adhesive, or snap fasteners, any of which may be used
alone or in combination with each other and/or with hook and loop
attachment features. A release liner or backing may be used to
expose the adhesive on the fastening device. In some
implementations, the fastening device 120 may be secured to either
or both of the sheets of material 105, 115 by sewing or stapling,
for example. In some embodiments, the fastening device may be a
mechanical fastener (e.g., rivet, staple).
[0035] In some embodiments, one or both of the second sheet of
material 115 and/or fastening device 120 may be integrally formed
with the dressing first sheet of material 105. For example, a cut
may be made along the perimeter of one side of the first sheet of
material 105 from opposing ends of the sides, leaving an
intermediate portion intact. In another example, markings or
perforations may be made to guide the tearing of the second sheet
of material 115 and the fastening device 120 from the first sheet
of material 105. In some implementations, the first sheet of
material 105 may be pre-formed into a shape that allows for the
fastening device 120 to be longer than the second sheet of material
115.
[0036] In some examples, the system 100 may be configured to manage
and organize the components of the IV line by retaining each
component at certain positions relative to other components. In
some embodiments, the junction may form a connection between the
catheter-and-hub assembly with either a saline cap, IV tubing
extension set, or full IV tubing.
[0037] In some embodiments, a multiple attachment mechanisms could
be integrated into a single strip. In some implementations, two or
more second sheets of material 115 may be attached to the first
sheet of material 105. Each of these second sheets of material 115
may wrap around the tubing. In some examples, one or both of these
may directly contact the tubing, and one or both sheets may
subsequently wrap around the body part in respectively opposite
directions to provide further reinforcement. In some examples,
these sheets may positioned substantially parallel and adjacent
with one another and directly wrap around the tubing at different
positions.
[0038] Although not meant to be in any way limiting, for purposes
of simplifying explanation, the term "axial" forces as used with
reference to an IV site on a limb (e.g., arm or leg) as depicted in
the figures should be understood as referring to forces parallel to
a central axis of an imaginary cylinder extending approximately
along the length of the IV tubing around the point the tubing is
anchored to the dressing. "Radial" forces should generally be
understood as force components that are normal to this axis.
[0039] A number of implementations have been described.
Nevertheless, it will be understood that various modification may
be made. For example, advantageous results may be achieved if the
steps of the disclosed techniques were performed in a different
sequence, or if components of the disclosed systems were combined
in a different manner, or if the components were supplemented with
other components. Accordingly, other implementations are
contemplated.
* * * * *