U.S. patent application number 13/879271 was filed with the patent office on 2013-09-05 for highly uniform spunbonded nonwoven fabrics.
This patent application is currently assigned to FIBERWEB, INC.. The applicant listed for this patent is John F. Baker, JR.. Invention is credited to John F. Baker, JR..
Application Number | 20130228510 13/879271 |
Document ID | / |
Family ID | 45565343 |
Filed Date | 2013-09-05 |
United States Patent
Application |
20130228510 |
Kind Code |
A1 |
Baker, JR.; John F. |
September 5, 2013 |
HIGHLY UNIFORM SPUNBONDED NONWOVEN FABRICS
Abstract
A catheter anchoring system, apparatus and method for securing a
catheter to a patient's skin, having two flexible side members and
a cross-member therebetween to which a retaining assembly is
mounted. The retaining assembly may hold a catheter hub at an angle
for patient comfort. Gripping tabs secure to each retaining
assembly side are gripped while advancing a cannula guide needle
into the patient's vein and while attaching the catheter hub to a
medical accessory, such as intravenous (I.V.) tubing, for increased
patient comfort, reduction of the risk in contamination and patient
infection, and to more easily and quickly start an I.V.
Inventors: |
Baker, JR.; John F.;
(Nashville, TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Baker, JR.; John F. |
Nashville |
TN |
US |
|
|
Assignee: |
FIBERWEB, INC.
Old Hickory
TN
|
Family ID: |
45565343 |
Appl. No.: |
13/879271 |
Filed: |
October 6, 2011 |
PCT Filed: |
October 6, 2011 |
PCT NO: |
PCT/US11/55139 |
371 Date: |
May 8, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61390489 |
Oct 6, 2010 |
|
|
|
Current U.S.
Class: |
210/500.27 ;
264/103; 428/219; 442/335; 442/337; 442/401; 442/409 |
Current CPC
Class: |
Y10T 442/609 20150401;
D04H 3/011 20130101; Y10T 442/69 20150401; Y10T 442/611 20150401;
A61M 25/02 20130101; A61M 2025/024 20130101; Y10T 442/681 20150401;
A61M 2025/028 20130101; A61M 2025/0266 20130101 |
Class at
Publication: |
210/500.27 ;
442/409; 428/219; 442/401; 442/335; 442/337; 264/103 |
International
Class: |
D04H 3/011 20060101
D04H003/011 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 17, 2011 |
US |
13029944 |
Claims
1. An article, comprising: a nonwoven fabric comprising a plurality
of continuous fibers; wherein each fiber of the plurality of
continuous fibers comprises a single polymer, the single polymer
comprises a polyester, and the continuous fibers are randomly
thermally bonded throughout the nonwoven substrate.
2. An article, comprising: a nonwoven fabric comprising a plurality
of fibers; wherein the nonwoven fabric has a M-4 web uniformity
index of at most about 600 and, when the nonwoven fabric has a unit
weight of 34 gsm, the nonwoven fabric has a tensile strength of at
least about 10 pounds in a cross-machine direction as measured
according to ASTM D4595-09.
3. An article, comprising: a nonwoven fabric comprising a plurality
of spunbonded fibers; wherein the nonwoven fabric has a M-4 web
uniformity index of at most about 600.
4. An article, comprising: a nonwoven fabric comprising a plurality
of fibers; wherein, when the nonwoven fabric has a unit weight of
34 gsm, the nonwoven fabric has a tensile strength of at least
about 10 pounds in a cross-machine direction as measured according
to ASTM D4595-09; and wherein the fibers are randomly thermally
bonded throughout the nonwoven fabric.
5. The article of claim 3, wherein each fiber comprises a single
polymer.
6. The article of claim 4, wherein the single polymer comprises a
polyester.
7. The article of claim 1, wherein the single polymer is a
polyethylene terephthalate, a polybutylene terephthalate, a
polytrimethylene terephthalate, a polyethylene naphthalate, a
polyglycolide, a polylactide, a polycaprolactone, a polyethylene
adipate, a polyhydroxyalkanoate, or a copolymer thereof.
8. The article of claim 1, wherein the single polymer has an
intrinsic viscosity of at least about 0.5 dl/g and at most about
0.7 dl/g.
9. (canceled)
10. The article of claim 1, wherein at least some of the fibers
have a circular cross-section.
11. The article of claim 10, wherein the circular cross-section has
an average diameter of from about 6 .mu.m to about 20 .mu.m.
12. The article of claim 1, wherein at least some of the fibers
have a trilobal, quadrulobal, pentalobal, or octalobal
cross-section.
13. The article of claim 12, wherein the cross-section has an
average diameter of from about 1 .mu.m to about 6 .mu.m.
14. The article of claim 2, wherein the fibers are randomly bonded
throughout the nonwoven substrate.
15. The article of claim 1, wherein, when the nonwoven fabric has a
unit weight of 34 gsm, the nonwoven fabric has a tensile strength
of at least about 10 pounds in a cross-machine direction as
measured according to ASTM D4595-09.
16. The article of claim 1, wherein the nonwoven fabric has a M-4
web uniformity index of at most about 600.
17-22. (canceled)
23. A product, comprising the article of claim 1, wherein the
product is a membrane filtration medium.
24. The product of claim 23, wherein the product is a reverse
osmosis filtration medium.
25. A method, comprising: extruding a composition containing a
single polymer to form a plurality of unbonded continuous fibers,
the single polymer comprising a polyester; mechanically drawing the
unbonded continuous fibers; and area bonding the unbonded
continuous fibers to form a nonwoven fabric comprising a plurality
of bonded continuous fibers.
26. The method of claim 25, wherein the area bonding comprises
through-air bonding the unbonded continuous fibers to form the
nonwoven substrate.
27. The method of claim 25, wherein the area bonding is carried out
at a temperature of at least about 145.degree. C. and at most about
250.degree. C.
28. (canceled)
29. The method of claim 25, wherein the mechanically drawing
comprises passing the unbonded continuous fibers through at least
two draw rolls to form oriented fibers.
30. The method of claim 29, wherein each of the two draw rolls has
a fiber speed of at least about 1,800 meters per minute.
31. The method of claim 25, wherein, after area bonding the
unbonded continuous fibers, the method further comprises
calendering the nonwoven substrate to form a calendered
product.
32. The method of claim 31, wherein the calendering is carried out
at a temperature of at least about 145.degree. C. and at most about
215.degree. C.
33-34. (canceled)
35. The method of claim 25, wherein the bonded continuous fibers
comprise spunbonded fibers.
36. The article of claim 1, wherein the continuous fibers are
randomly thermally bonded by area bonding.
37. The article of claim 4, wherein the fibers are thermally bonded
by area bonding.
38. The article of claim 4, wherein the nonwoven fabric does not
comprise a polymer having an intrinsic viscosity higher than about
0.64 dl/g.
39. An article, comprising: a nonwoven fabric comprising a
plurality of continuous, spunbonded fibers; wherein each fiber of
the plurality of continuous, spunbonded fibers comprises a single
polymer, the single polymer comprises a polyester, and the
continuous fibers are randomly thermally bonded throughout the
nonwoven substrate; wherein the nonwoven fabric has a M-4 web
uniformity index of at most about 600 and, when the nonwoven fabric
has a unit weight of 34 gsm, the nonwoven fabric has a tensile
strength of at least about 10 pounds in a cross-machine direction
as measured according to ASTM D4595-09.
Description
TECHNICAL FIELD
[0001] The subject disclosure relates to catheter anchoring and
supporting devices, and more specifically relates to catheter
anchoring system, apparatus and method characterized by a removably
mountable anchoring device for receiving a catheter hub of a
catheter assembly, such that the anchoring device may be used as a
guide to insert a cannula guide needle and associated cannula
(e.g., intravenous cannula) of a catheter assembly into a patient's
vein. Mounting the anchoring device to the patient limits movement
of the catheter assembly in relation to the patient after cannula
insertion. The anchoring device may dispose the catheter cannula at
a preferred angle in relation to the patient. The anchoring device
is shaped to facilitate asepsis when wrapped with an aseptic
dressing. The subject disclosure is particularly relevant to aiding
in the insertion of an intravenous (I.V.) cannula, increasing
patient comfort and safety, reducing the risk of I.V. site
contamination, and reducing the risk of patient infection.
BACKGROUND ART
[0002] A variety of catheter anchoring and supporting devices are
discussed in the prior art. One example is a catheter anchoring and
supporting device which has two adhesive members connected by an
adhesive bridge to secure the members in a doubled over form when
the two main members are used to position a catheter tube to a
patient. Another example is catheter anchoring and supporting
system that has an adhesively-attachable single-piece having two
channels connected by a bridge, each channel for receiving a
tubular segment.
[0003] However, these catheter anchoring and supporting system and
devices do not address the desirable feature of aiding in the
insertion of a catheter cannula into a catheter insertion site
(e.g., a vein) of a patient. These catheter anchoring and support
systems do not receive the hub of a catheter. Further, these
catheter tube holders do not provide adequate adhesion between the
patient's skin and the catheter insertion site to prevent a
substantial displacement of the inserted cannula from the insertion
site such as when any outward force is applied to the catheter
tubing when moving a patient or when a patient is moving the area
having the cannula inserted therein.
[0004] What is needed is an adhesively-attachable catheter
anchoring apparatus having two side members and a cross-member
therebetween, the cross-member having a retaining assembly
integrated therein for receiving the catheter hub of a catheter
assembly and for holding the associated cannula guide needle and
the surrounding cannula at approximately a 3-degree angle (e.g., or
any desired angle) and further having two vertically-oriented
gripping tabs disposed on each side of the retaining assembly, to
optionally be gripped while advancing the catheter assembly in the
direction to pierce the vein with the cannula guide needle and to
guide the cannula into a desired vein without requiring operator
contact with the cannula or cannula guide needle, thus reducing the
risk of an operator contaminating the catheter, thereby reducing
the risk of patient infection, while also making starting the I.V.
easier and faster. The present catheter anchoring apparatus
addresses the foregoing needs by providing an adhesively-attachable
H-shaped catheter anchoring apparatus with two side members and a
cross-member there between, the cross-member having a retaining
assembly integrated therein for receiving a catheter hub in a
position desirable for insertion and for assisting in the
advancement of a cannula guide needle into a patient's vein.
DISCLOSURE OF THE INVENTION
[0005] A simplified summary is provided herein to help enable a
basic or general understanding of various aspects of exemplary,
non-limiting embodiments that follow in the more detailed
description and the accompanying drawings. This summary is not
intended, however, as an extensive or exhaustive overview. Instead,
the sole purpose of this summary is to present some concepts
related to some exemplary non-limiting embodiments in a simplified
form as a prelude to the more detailed description of the various
embodiments that follow.
[0006] An embodiment of the present catheter anchoring system,
apparatus and method includes a rectangular first side member
having an upper portion, a lower portion, an inner side, and an
outer side. A rectangular second side member is in a
closely-spaced, parallel relation to the rectangular first side
member. The second side member has a top portion, a bottom portion,
an inner edge and an outer edge. A cross-member is located between
the first side member and the second side member, such that the
apparatus attains an H-shaped configuration. The cross-member is
substantially rectangular having a top side, a bottom side, an
outer first edge, an outer second edge, a front edge, and a rear
edge. A retaining assembly is located on the cross-member with a
longitudinally positioned channel inside for removably securing a
catheter hub. When the apparatus is placed on a patient's arm, the
retaining assembly has a right side and a left side. The retaining
assembly is mounted to the center of the top side of the
cross-member. A plurality of retaining fingers is mounted to the
right side and the left side of a retaining assembly. A first
gripping tab is mounted to the top side of the cross-member in
vertical relation to it and between the retaining assembly right
side and the outer first edge of the cross-member. A second
gripping tab is mounted to the top side of the cross-member in
vertical orientation to the top side and between the retaining
assembly left side and the outer second edge of the cross-member. A
vertical tab is mounted to the top side of the cross-member. The
first side member and the second side member are in vertical
orientation thereto and between the outer side of the first side
member and the outer edge of the second side member. The vertical
tab has a front face, a rear face, and a bottom edge surface. The
bottom edge surface is connected to the top side of the
cross-member. The first side member and the second side member are
in parallel relation to the front edge. Adhesive for an adhesive
layer is bonded to a bottom surface of the apparatus. The adhesive
is selected from a class of adhesives that are suitable for use on
human skin. A backing removably covers the adhesive layer.
According to an embodiment, the backing has additional, continuous
backing that is substantially the same size as the size of backing
that removably cover the adhesive layer. The additional backing is
folded over the backing. The additional backing extends to the side
of the catheter apparatus opposite the fold. A backing removal
extension piece, that is attached to the backing, extends beyond
the catheter apparatus for removal of the backing through the act
of pulling the backing removal extension piece, the attached
additional backing, and exposing the attached backing.
[0007] Another embodiment of the present catheter anchoring system,
apparatus and method is provided to securely anchor a catheter to a
site on a patient's skin. The device has a flexible, rectangular
first side member with an upper portion, a lower portion, an inner
side, and an outer side and a flexible, rectangular second side
member with a top portion, a bottom portion, an inner edge, and an
outer edge. The side members are adapted to be secured to the skin
of a patient in closely-spaced, parallel relation. The device
further features a rigid cross-member having top side, a bottom
side, an outer first edge, an outer second edge, a front edge, and
a rear edge. The outer first edge is affixed to the center of the
upper portion, near the inner side of the first side member and the
second edge affixed to the center of the top portion, near the
inner edge of the second side member. A retaining assembly has a
longitudinally disposed channel therein for removably securing a
catheter adaptor. The retaining assembly is mounted to the center
of the top side of the cross-member. An indention in the rear edge
of the cross-member is adjacent to the retaining assembly. The
indention is configured to allow a catheter hub to be removably
secured within the channel. A first gripping tab is mounted to the
top side of the cross-member in a vertical relation thereto and
between the retaining assembly right side and the first edge of the
cross-member. The first gripping tab has a front side, a rear side,
and a bottom edge. The bottom edge is affixed to the top side of
the cross-member in a parallel position in relation to the front
edge. A second gripping tab is mounted to the top side of the
cross-member in vertical relation thereto and between the retaining
assembly left side and the second edge of the cross-member. The
second gripping tab has a front wall, a rear wall and a lower edge.
The lower edge is affixed to the top side of the cross-member in a
parallel position in relation to the front edge. An adhesive layer
is located on the lower portion of the first side member, on the
bottom portion of the second side member, and on the cross-member.
A backing removably covers the adhesive layer. The backing includes
a backing removal extension piece.
[0008] To use the present device, before insertion of the catheter,
the hub of the catheter is snapped into the retaining assembly by
the user, such as a nurse or physician. Then, gripping one of the
tabs on either side of the retaining assembly, depending on the
dominant hand of the user, the catheter is advanced after locating
and piercing the vein with a cannula guide needle. Using the tabs
to advance the catheter reduces the risk of an operator
contaminating the catheter and passing bacteria to the patient
because the operator's gloved fingers would not come into direct
contact with the catheter itself or the cannula. Conventionally, a
user uses a thumbnail to push on a ridge of the hub of the catheter
thereby making it very easy to contaminate the catheter by touching
the catheter (e.g., cannula) before it enters the vein, which may
occur even more often when the catheter operator has large fingers.
After the catheter is in place, the operator holds one of the tabs
while attaching, for example, a saline lock or I.V. tubing with the
other hand. The side members and cross-member are then slightly
lifted as the backing is removed, and then the entire apparatus is
pressed down to secure the device to a patient's skin. This device
is much less cumbersome than securing a catheter into place with
tape, particularly when the nurse or physician is wearing gloves.
In addition, the present device reduces a patient's pain when
moving about because the catheter and I.V. do not pull at the site
of the insertion.
[0009] As such, the general purpose of the improved catheter
anchoring system, apparatus and method which has all of the
advantages of the prior art mentioned heretofore and many novel
features that result in an improved catheter anchoring system,
apparatus and method which is not anticipated, rendered obvious,
suggested, or even implied by the prior art, either alone or in
combination thereof.
[0010] An object of the present catheter tube anchoring device to
reduce the risk of contamination of a catheter through contact with
non-sterile surfaces, thereby reducing the risk of patient
infection.
[0011] Another object of the present catheter tube anchoring device
is to make the starting of an I.V. much easier and faster than
permitted by prior art devices.
[0012] Yet another object of the present catheter tube anchoring
device is to easily secure a catheter to a patient's skin.
[0013] Still further, another object of the present catheter tube
anchoring device is to substantially immobilize the IV to the skin
of a patient, thereby reducing pain caused by movement of the IV in
relation to the patient.
[0014] Thus has been broadly outlined the more important features
of the improved catheter tube anchoring device so that the detailed
description thereof that follows may be better understood and in
order that the present contribution to the art may be better
appreciated.
[0015] The above-described deficiencies of today's systems for
catheter anchoring are merely intended to provide an overview of
some of the problems of conventional systems, and are not intended
to be exhaustive. Other problems with the state of the art and
corresponding benefits of some of the various non-limiting
embodiments may become further apparent upon review of the
following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Various non-limiting embodiments are further described with
reference to the accompanying drawings in which:
[0017] FIG. 1 is a schematic isometric top view of an embodiment of
the catheter anchoring system, apparatus and method, according to
an embodiment.
[0018] FIG. 2 is a schematic perspective right side view of an
embodiment of the present disclosure.
[0019] FIG. 3 is a schematic isometric bottom view of an
embodiment.
[0020] FIG. 4 is a schematic isometric bottom view of an
embodiment.
[0021] FIG. 5 is a schematic top view of an embodiment.
[0022] FIG. 6 is a schematic bottom view of an embodiment.
[0023] FIG. 7 is a schematic right side view of an embodiment.
[0024] FIG. 8 is a schematic front view of an embodiment.
[0025] FIG. 9 is a schematic back view of an embodiment.
[0026] FIG. 10a is a schematic side view of a catheter hub
according to an embodiment.
[0027] FIG. 10b is a cross sectional view along the line 10b-10b of
FIG. 9.
[0028] FIG. 11 is a schematic isometric top view of an embodiment
having a catheter hub inserted therein.
[0029] FIG. 12 is a schematic perspective rear view of an
embodiment having a catheter hub inserted therein.
[0030] FIG. 13a is a schematic isometric top view of an embodiment
containing a winged catheter hub attachment.
[0031] FIG. 13b is a schematic perspective rear view of an
embodiment containing a winged catheter hub attachment.
[0032] FIG. 13c is a schematic top view of an embodiment containing
a winged catheter hub attachment.
[0033] FIG. 14 is a schematic in-use drawing of a catheter hub and
associated cannula and need being snapped into an embodiment.
[0034] FIG. 15 is a schematic in-use drawing of a method for
locating the needle of a catheter on the surface of a patient's
skin, according to an embodiment.
[0035] FIG. 16 is a schematic in-use drawing of a method for
removing the needle while advancing the cannula of the catheter
into a patient's skin, according to an embodiment.
[0036] FIG. 17 is a schematic in-use drawing of a method of
attaching a medical accessory to the catheter hub, according to an
embodiment.
[0037] FIG. 18 is a schematic in-use drawing of a method of
attaching a providing additional securement to an embodiment with
the use of adhesive medical strips.
[0038] FIG. 19 is a schematic top view of an embodiment
additionally secured with adhesive medical strips.
[0039] FIG. 20 is a schematic in-use drawing of an embodiment as it
is secured to the skin with an adhesive backing, holding the
cannula of a catheter hub in place with a medical accessory
attached to the catheter hub.
[0040] FIG. 21 is a schematic front-right perspective view of an
embodiment having an integrated catheter hub and a cannula
extending therefrom.
[0041] FIG. 22 is a schematic rear-left perspective view of an
embodiment.
[0042] FIG. 23 is a schematic top view of an embodiment.
[0043] FIG. 24 is a schematic bottom view of an embodiment.
[0044] FIG. 25 is an isometric top view of an embodiment.
[0045] FIG. 26 is an isometric bottom view of an embodiment.
[0046] FIG. 27 is a top plan view of an embodiment.
[0047] FIG. 28 is a cross-section view of an embodiment taken along
line 4-4 of FIG. 27.
[0048] FIG. 29 is an isometric in-use view of an embodiment.
[0049] FIG. 30 is an isometric top view of an embodiment.
[0050] FIG. 31 is an isometric bottom view of an embodiment.
BEST MODES FOR CARRYING OUT THE INVENTION AND INDUSTRIAL
APPLICABILITY
Overview
[0051] The claimed subject matter is now described with reference
to the drawings, wherein like reference numerals are used to refer
to like elements throughout. In the following description, for
purposes of explanation, numerous specific details are set forth in
order to provide a thorough understanding of the claimed subject
matter. It may be evident, however, that the claimed subject matter
may be practiced without these specific details. In other
instances, well-known structures and devices may be shown in block
diagram form in order to facilitate describing the claimed subject
matter.
[0052] Moreover, the word "exemplary" is used herein to mean
serving as an example, instance, or illustration. Any aspect or
design described herein as "exemplary" is not necessarily to be
construed as preferred or advantageous over other aspects or
designs. Rather, use of the word exemplary is intended to present
concepts in a concrete fashion. As used in this application, the
term "or" is intended to mean an inclusive "or" rather than an
exclusive "or." Therefore, unless specified otherwise, or clear
from context, "X employs A or B" is intended to mean any of the
natural inclusive permutations. That is, if X employs A; X employs
B; or X employs both A and B, then "X employs A or B" is satisfied
under any of the foregoing instances. In addition, the articles "a"
and "an" as used in this application and the appended claims should
generally be construed to mean "one or more" unless specified
otherwise or clear from context to be directed to a singular
form.
[0053] With reference now to the drawings, and in particular FIGS.
1 through 31 thereof, various embodiments employing the principles
and concepts of the present catheter anchoring system, apparatus
and method, generally designated by the reference number 10, will
be described.
[0054] Referring to FIGS. 1 through 31, various embodiments of the
present catheter anchoring system, apparatus and method 10 are used
to secure a catheter assembly (e.g., including a cannula placed in
the skin and a medical attachment such as intravenous tubing
connected to a hub in fluid communication with said cannula) to a
patient. The present apparatus 10 provides a rectangular first side
member 20, a rectangular second side member 40 in closely-spaced,
parallel relation to the first side member 20, and a cross-member
60 there between thereby forming an H-shaped configuration,
according to some embodiments. It is recognized by those skilled in
the art that the cross-member 60 may be placed at any location
along the parallel side members according to some embodiments. The
first side member 20 has an upper portion 22, a lower portion 24,
inner side 26, and an outer side 28. The second side member 40 has
a top portion 42, a bottom portion 44, an inner edge 46, and an
outer edge 48.
[0055] According to an embodiment shown in FIGS. 25 through 31, the
generally rectangular cross-member 60 has top side 62, a bottom
side 64, an outer first edge 66, an outer second edge 68, a front
edge 70, and a rear edge 72. The outer first edge 66 is attached to
the inner side 26 of the first side member 20. The outer second
edge 68 is attached to the inner edge 46 of the second side member
40. According to an embodiment, the outer first edge 66 is attached
at any point along the inner side 26 of the first side member 20,
such that the cross-member 60 and the outer first edge 66 are in a
substantially perpendicular configuration. The outer second edge 68
is attached at any point along the inner edge 46 of the second side
member 40, such that the cross-member 60 and the outer second edge
68 are in a substantially perpendicular configuration.
[0056] According to an embodiment as shown in FIGS. 1 through 31,
the present apparatus is constructed from a single polymer having
operational elastomeric characteristics such that the apparatus is
selectively flexible according to the type of polymer chosen. One
application of a flexible apparatus is that a single design (e.g.,
an apparatus configuration of a single size) of the apparatus can
adapt to (e.g., fit) a greater percentage of patients' arms (e.g.,
appendages). Another application of a flexible apparatus is to
increase usability in situations where a patient's skin may be very
tender and sensitive to the placement of rigid or ill-fitting
medical devices on their body. A substantial benefit is realized by
having the ability to change the composition of the polymer used as
the substrate for the apparatus and as a result, directly change
the operational elastomeric characteristics of the apparatus as a
whole. As might be expected, the possible applications of this
ability are numerous. According to some embodiments, the use of
more than one polymer is contemplated, for example, for creating a
soft surface to be placed against a patient's skin and a rigid
surface to receive the catheter hub. Other such combinations of
more than one polymer are possible for a variety of purposes, but
are not illustrated here.
[0057] Corners 128 (e.g., where edges of two side members meet) of
the first and second side members, according to an embodiment, are
trimmed (e.g., by filleting, chamfering or any other suitable
technique) such that the corners do not catch on dressings or other
materials that might be placed in contact with the first and second
side members. The edges 129 of the first and second side members,
similarly, are ground down (e.g., buffed, radiused) in order to
reduce the sharpness of the edges, so that the edges to not catch
on or damage dressings or other materials that might be placed in
contact with the first and second side members.
[0058] The top or upper portions of an embodiment of the first or
second side members contains at least one longitudinally scored
portion 120, parallel to a longitudinal edge (e.g., an edge that
runs perpendicular to the cross-member), to increase flexibility of
the primary support structure at that scored portion 120. According
to an embodiment, two scored portions 120 are employed such that
one scored portion 120 extends from the top portion of the first
side member a distance downwards into the first side member and the
second scored portion 120 extends from the upper portion of the
second side member a distance downwards into the second side
member. The scored portions 120 are disposed in a parallel
configuration with each other and with a longitudinal edge of the
first and second side members. The position, depth and number of
the scored portions 120 is chosen to increase or decrease lateral
flexibility (e.g., flexibility along a line parallel to the
cross-member) of the first and second side members without
modifying the polymer from which the apparatus is constructed. For
example, the scored portions 120 may extend from a top portion
downward into the first side member a distance of approximately 0.8
millimeters. According to other embodiments, the range of the depth
of the scored portions 120 may range from 0 millimeters to 1.5
millimeters. According to an even further embodiment, the range may
be from 0.5 millimeters to 1 millimeter. According to an even
further embodiment, the range may be from 0.7 millimeters to 0.9
millimeters. The scored portions 120 reduce the strength of the
polymer at the scored portions 120, allowing the outermost edges of
the first and second side portions to be bendable (e.g., acting as
wings that can be bent to conform to a patient's arm). One
advantage of bending the first and second side portions might be to
more readily secure the assembly by surrounding an appendage of a
patient with the retaining assembly 80.
[0059] According to an embodiment, a retaining assembly 80 having a
longitudinally disposed channel 82 therein is configured to
removably secure a catheter hub 100 (e.g., catheter adaptor). The
retaining assembly 80 is mounted to the center of the top side 62
of the cross-member 60. The retaining assembly 80 is attached to
the cross-member 60 so that the catheter hub 100 is held at a
3-degree angle 87 to increase patient comfort. According to various
other embodiments, the retaining assembly 80 could hold the
catheter hub 100 at any desired angle in relation to the
cross-member 60. According to further embodiments, the retaining
assembly could hold a catheter hub of any desired size.
[0060] According to an embodiment, the retaining assembly 80 has a
right side 84 and a left side 85. The position of the retaining
assembly 80 in the center of the top side 62 of the cross-member 60
balances the retaining assembly 80 in a central position not only
for patient comfort while the catheter apparatus 10 is moved about,
but also for aiding removal of backing 30 from an adhesive layer 99
to secure the apparatus 10 to a patient 200 without jarring the
position of the catheter assembly, thus further increasing patient
comfort. The adhesive for the adhesive layer 99 is selected from a
class of adhesives that are suitable for use on human skin. Various
adhesives can be chosen for various embodiments depending on the
degree of adhesion required and other factors (e.g., type of skin
to be used on, length of time the adhesive must remain
adhered).
[0061] According to an embodiment, an indention 90 in the rear edge
72 of the cross-member 60 and adjacent to the retaining assembly 80
is optionally configured to allow a catheter hub 100 to be
removably secured within the channel 82. Optionally, an indention
90 increases the ease with which a catheter hub 100 is inserted
into the retaining assembly 80. Insertion of a catheter hub 100 in
to the retaining assembly 80 is aided by the presence of the
indention 90 in the cross-member 60 when compared to a retaining
assembly 80 affixed to a cross-member 60 without the indention
90.
[0062] According to an embodiment, the retaining assembly 80 has a
plurality of retaining fingers 110 that mount to the right side 84
and the left side 85 of the retaining assembly 80. These retaining
fingers 110 (e.g., retaining members) may number four, and may be
positioned at a longitudinal end of the retaining assembly 80. The
retaining fingers extend away from the right side 84 and the left
side 85 in a circular manner, essentially "grabbing" a catheter hub
100 as it is inserted into the retaining assembly 80, and acting to
securing the catheter hub 100, preventing the catheter hub 100 from
being removed from the retaining assembly 80.
[0063] According to an embodiment, a three-dimensional support
structure 112 surrounds, and is integrated (e.g., molded) or
otherwise part of the retaining assembly 80. The support structure
112 includes a substantially triangular, sloped element 114
integrated into both sides of the retaining assembly 80 in order to
integrate the retaining assembly 80 with the cross-member 60 and
prevent it from moving in relation to the catheter apparatus 10. In
addition to physically supporting the retaining assembly 80, the
sloped elements' primary sloped surface 116 is adapted to receive
an adhesive backed surface of aseptic tape or of an aseptic
dressing, so that the adhesive backed surface can be adhered (e.g.,
sealed) substantially continuously to the sloped surfaces, forming
a shield between the surrounding environment and the retaining
assembly, preventing bacteria from reaching the catheter insertion
site.
[0064] According to an embodiment, a first gripping tab 50 is
mounted to the top side 62 of the cross-member 60 in vertical
relation thereto and between the retaining assembly right side 84
and the outer first edge 66 of the cross-member 60. The first
gripping tab 50 has a front side 51, a rear side 52 and a bottom
edge 53. The bottom edge 53 is affixed to the top side 62 of the
cross-member 60 in parallel position in relation to the front edge
70. A rigid second gripping tab 55 mounted to the top side 62 of
the cross-member 60 in vertical relation thereto and between the
retaining assembly 80 left side 85 and the outer second edge 68 of
the cross-member 60. The second gripping tab 55 has a front wall
56, a rear wall 57, and a lower edge 58. The lower edge 58 is
affixed to the top side 62 of the cross-member 60 in parallel
position in relation to the front edge 70. The gripping tabs reduce
the risk of contaminating the catheter by preventing direct contact
of the operator's fingers with the catheter itself. Thus, the risk
of infecting a patient 200 is mitigated. The use of the gripping
tabs 50, 55 for advancing the catheter apparatus 10 and associated
cannula guide needle 101 into the patient's 200 vein reduces the
likelihood of contamination and potential for patient infection. In
an embodiment, each of the first gripping tab 50 and the second
gripping tab 55 have a triangular prism shape which has the same
footprint as the preferred embodiment first gripping tab 50 and the
second gripping tab 55. In this embodiment each of the first
gripping tab 50 and the second gripping tab 55 have an internal
cavity 54 therein and a rectangular front side 51, 56 perpendicular
to the cross-member 60, as shown in FIG. 6. During use the front
side 51, 56 of each of the first and second gripping tabs 50, 55
faces the user.
[0065] According to an embodiment, a vertical tab 118 is mounted to
the top side 62 of the cross-member 60, the first side member 20
and the second side member 40, in vertical relation thereto, and
between the outer side 28 of the first side member and the outer
edge 48 of the second side member. The vertical tab 118 has one or
more longitudinally scored portions 120, each perpendicular to the
cross-member 60 and positioned adjacent to the scored portions 120
in the first side member 20 and the second side member 40. The
width of the longitudinally scored portions 120 matches the width
of the scored portions 120 in the first side member 20 and the
second side member 40. The vertical tab 118 is integrally mounted
around the retaining assembly 80 such that it does not interfere
with access to the channel 82 of the retaining assembly 80. The
vertical tab 118 has a front face 122, a rear face 124, and a
bottom edge surface 126. The bottom edge surface 126 is affixed to
the top side 62 of the cross-member 60, the first side member 20
and the second side member 40 in parallel position in relation to
the front edge 70. The front face 122 of the vertical tab 118 is
adapted to receive the adhesive backed surface of aseptic tape or
of an aseptic dressing, so that the adhesive backed surface can be
adhered substantially continuously to the vertical tab 118.
Combined with the sloped elements 114, a shield may be formed
around the retaining assembly 80, preventing foreign particles
(e.g., bacteria) from entering the catheter insertion site, and
also possibly preventing infection.
[0066] According to an embodiment, the vertical tab 118 also
reduces the risk of contaminating the catheter hub 100 by
preventing direct contact of the operator's fingers with the
catheter hub 100 or catheter itself. Thus, the risk of infecting a
patient 200 is reduced. The use of the rear face 124 of the
vertical tab 118 for advancing the cannula guide needle 101 (e.g.,
placing an operator's fingers only on the rear face 124 in order to
advance the guide needle and surrounding cannula) into the
patient's 200 vein reduces the likelihood of contamination and
potential for patient 200 infection. Additionally, use of only the
rear face 124 maintains the front face 122 in an aseptic condition
for when a dressing is placed over the retaining assembly 80.
[0067] An adhesive layer 99, shown in FIGS. 3, 8 and 26 according
to an embodiment, is disposed on the lower portion 24 of the first
side member 20, on the bottom portion 44 of the second side member
40, and on the bottom side 64 of the cross-member 60, permits the
apparatus 10 to be secured to a patient's skin more quickly and
easily than securement with tape, although some embodiments, shown
in FIGS. 18 and 19, employ medical tape strips to provide for
further securement of the retaining assembly 80 once the adhesive
layer is exposed. In an embodiment, a backing 30 may cover the
adhesive layer 99 so that the catheter apparatus 10 can be
positioned without exposing and seating the adhesive layer 99. The
backing 30 may be one continuous backing that is folded over, such
that the folded over portion extends to the side of the catheter
apparatus 10 opposite the folded over portion, where a backing
removal extension piece extends beyond the catheter apparatus 10
for removal of the backing through the act of pulling the backing
removal extension piece 35. In an embodiment, an absorbent pad 105,
which is disposed on the entire bottom side 64 of the cross-member
60, the first side member 20 and the second side member 40, is
substituted for the adhesive layer 99.
[0068] According to an embodiment, a pressure-released polymer
adhesive-containing capsule 107 is disposed within the internal
cavity 54 of each of the first and second gripping tabs 50, 55.
Each of the capsules 107 has a diameter of approximately 1/8 inch.
According to an embodiment, in use, when securing the alternative
embodiment of the apparatus 10 to the patient, the user places
pressure on the first and second gripping tabs 50, 55 to break open
the capsules 107 therein and to release the polymer adhesive which
passes through mesh openings 108 disposed on an bottom edge 53 of
each of the first and second gripping tabs 50, 55 to permeate the
absorbent pad and then onto user's skin to adhere the apparatus 10
onto the patient's skin. Alternatively, the polymer adhesive is
released onto and through the absorbent pad 105 onto the patient's
skin and then combines with a second adhesive which has already
been applied to the patient's skin, prior to the polymer adhesive,
and the combination thereof secures the apparatus 10 onto the
patient's skin.
[0069] According to an embodiment, a backing 30, which removably
covers the adhesive layer 99 has a rectangular first part 31, a
rectangular second part 32, a L-shaped third part 33, and a
L-shaped fourth part 34. The first part 31, second part 32, third
part 33, and fourth part 34, each having a backing removal
extension piece 35. In the alternative embodiment, the backing 30
removably covers the absorbent pad 105.
[0070] According to an embodiment, an adhesive layer 99 is disposed
on the lower portion 24 of the first side member 20, on the bottom
portion 44 of the second side member 40, and on the bottom side 64
of the cross-member 60. The adhesive layer 99 may be applied to the
lower portion 24, the bottom portion 44, or the bottom side 64 at
separate times or at the same time. A backing 30 is disposed on the
adhesive layer 99 (e.g., the portion of the adhesive layer opposite
the lower portion 24, bottom portion 44, or bottom side 64) such
that removal of the backing 30 will expose the adhesive layer 99,
enabling an un-backed portion of the apparatus to be adhered to a
surface. The backing 30 of the adhesive layer 99 may cover the
entire adhesive layer 99 or be scored and separated into multiple
portions for ease of de-backing when the apparatus is placed in
close proximity to the surface of a patient's skin. One or more
backing removal extension pieces 35 of the backing 30 may extend
past an edge of the apparatus so that an operator can grasp the
backing removal extension piece 35, and easily remove the backing
30 from the adhesive layer 99 underneath.
[0071] According to an embodiment, a spring-loaded push-release
button 110 is disposed atop an attachment end of a plastic housing
112 into which the cannula guide needle 101 is retracted.
[0072] An embodiment that can be used with a catheter having winged
attachments, such as the BD Nexiva.TM. brand closed IV catheter
system, commercially available from Beckton, Dickinson and Company
of Franklin Lakes, N.J., is shown in FIGS. 13a through 13c.
Operation, According to Various Embodiments
[0073] As shown in FIGS. 14 through 20, according to an embodiment,
to use the present apparatus 10, an operator, such as a nurse or
physician, begins by placing a catheter hub 100 securely into the
retaining assembly 80 before inserting an attached cannula guide
needle 101 into a patient. FIG. 9 shows a rear view of the catheter
apparatus 10, and FIG. 10b shows a cut-away view of FIG. 9, along
the line 10-10. FIG. 10a shows the catheter hub and FIG. 10b shows
where the catheter hub 100 is to be received. FIG. 11 shows an
example of one type of catheter hub that can be secured by the
catheter apparatus 10. FIGS. 12 and 14 shows that hub inserted into
the retaining assembly of the catheter apparatus 10. The operator
then proceeds by locating and piercing the patient's 200 vein with
a cannula guide needle 101 of the catheter hub 100. Then, gripping
either the first gripping tab 50 or second gripping tab 55, an
operator advances the cannula guide needle 101 into a patient's 200
vein. After the cannula guide needle and associated cannula is
desirably inserted into the vein, the operator grips either the
first gripping tab 50 or second gripping tab 55, depending on the
operator's dominant hand, while attaching corresponding I.V. tubing
with the operator's other hand.
[0074] According to an embodiment, to secure the apparatus 10 to
the patient's skin, the operator slightly lifts the cross-member 60
while removing the backing 30 by pulling on the backing extension
piece 35. After removing the backing 30, the user presses down on
the cross-member 60, first side member 20, and second side member
40 to secure the apparatus 10 to a patient 200.
[0075] According to an embodiment shown in FIGS. 14 through 20, a
user selects a site on the patient 200 for the site of the catheter
(e.g., and catheter apparatus 10) and prepares the site according
to a predetermined procedure. A tourniquet is applied to the arm of
the patient 200 at a point above the IV insertion point. The
catheter hub 100 of an intravenous catheter (e.g., still attached
to the I.V. starting device, such as a cannula guide needle 101) is
placed into the retaining assembly 80 where it becomes removably
attached to the catheter apparatus 10. With the catheter apparatus
10 and catheter hub 100 assembled, the vein is pierced with the
cannula guide needle 101. A thumb and forefinger can then be used
to grasp the vertical tab 118 on either side of the catheter hub
100 so that a force in the direction of the vein can be applied to
the catheter apparatus 10, causing the catheter (e.g., the cannula
of the catheter and the cannula guide needle) to advance into the
vein. At this point, the catheter assembly will be resting on the
skin of the patient. As the cannula guide needle 101 is retracted,
the catheter apparatus 10 is held in place by the vertical tab 118.
Ancillary catheter tubing is then secured, and the tourniquet is
removed from the arm of the patient 200. The catheter apparatus 10
is secured when the user pulls on the backing removal extension
piece 35, uncovering the adhesive layer on the underside of the
catheter apparatus 10, enabling the adhesive layer to come into
contact with the skin.
[0076] According to an embodiment, addition securement can be
provided by placing securement tape (e.g., steri-strips, medical
tape strips) over the apparatus 10 and the attached catheter hub
100. An example of one method of providing additional securement to
the apparatus is shown in FIG. 19.
[0077] According to other embodiments, for securing the device to
the patient's skin, the user slightly lifts the cross-member 60
while removing the backing 30 from the lower side 109 of the
absorbent pad 105 by pulling on a corresponding extension piece.
The user then places pressure on the first and second gripping tabs
50, 55 to break open the capsules 107 and to release the polymer
adhesive through the mesh openings 108 to permeate the absorbent
pad, and then onto to the user's skin to adhere the apparatus 10
onto the patient's skin. Alternatively, the polymer adhesive is
released onto and through the absorbent pad 105 onto the patient's
skin and then combines with a second adhesive which has already
been applied to the patient's skin, prior to the polymer adhesive,
and the combination thereof secures the apparatus 10 onto the
patient's skin. To retract the cannula guide needle, the user
pushes the spring-loaded push-release button 110 disposed atop an
attachment end of the plastic housing 112 in some embodiments.
[0078] FIGS. 21 through 24 illustrate an embodiment in which the
catheter apparatus 10 is an integrated part of a catheter, such
that the catheter hub 100 is integrated into (e.g., molded into)
the apparatus 10. A cannula is shown extending from an end of the
catheter hub, ready for insertion into a vein of a patient.
[0079] The word "exemplary" is used herein to mean serving as an
example, instance, or illustration. For the avoidance of doubt, the
subject matter disclosed herein is not limited by such examples. In
addition, any aspect or design described herein as "exemplary" is
not necessarily to be construed as preferred or advantageous over
other aspects or designs, nor is it meant to preclude equivalent
exemplary structures and techniques known to those of ordinary
skill in the art. Furthermore, to the extent that the terms
"includes," "has," "contains," and other similar words are used in
either the detailed description or the claims, for the avoidance of
doubt, such terms are intended to be inclusive in a manner similar
to the term "comprising" as an open transition word without
precluding any additional or other elements.
[0080] In view of the exemplary apparatus and methods described
supra, methodologies that may be implemented in accordance with the
disclosed subject matter will be better appreciated with reference
to the flowcharts of the various figures. While for purposes of
simplicity of explanation, the methodologies are shown and
described as a series of blocks, it is to be understood and
appreciated that the claimed subject matter is not limited by the
order of the blocks, as some blocks may occur in different orders
and/or concurrently with other blocks from what is depicted and
described herein. Moreover, not all illustrated blocks may be
required to implement the methodologies described hereinafter.
[0081] While the various embodiments have been described in
connection with the preferred embodiments of the various figures,
it is to be understood that other similar embodiments may be used
or modifications and additions may be made to the described
embodiment for performing the same function without deviating
therefrom. Therefore, the present invention should not be limited
to any single embodiment, but rather should be construed in breadth
and scope in accordance with the appended claims.
* * * * *