U.S. patent application number 16/653576 was filed with the patent office on 2020-02-06 for protective dressing for skin-placed medical device.
The applicant listed for this patent is C. R. Bard, Inc.. Invention is credited to Matthew W. Bown, Kelly J. Christian, Anthony S. Elangovan, Glade H. Howell, Jay A. Muse.
Application Number | 20200038543 16/653576 |
Document ID | / |
Family ID | 55436451 |
Filed Date | 2020-02-06 |
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United States Patent
Application |
20200038543 |
Kind Code |
A1 |
Howell; Glade H. ; et
al. |
February 6, 2020 |
Protective Dressing For Skin-Placed Medical Device
Abstract
A dressing for use in protectively covering and isolating a
medical device placed on and/or through the skin surface of a
patient is disclosed. Examples of such devices include infusion
needles for accessing subcutaneously implanted access ports,
catheters of various types and purposes, insulin infusion needles,
etc. In one embodiment, a dressing for covering a medical device on
a skin surface of a patient is disclosed and comprises a dressing
portion that is configured to rest against a skin surface of a
patient, with the dressing portion defining a hole, and a polymeric
cover film that is at least indirectly attached to the dressing
portion. The cover film includes a pliable domed portion aligned
with the hole of the dressing portion. The pliable domed portion
defines a cavity that is configured to receive therein the medical
device when the dressing is placed on the skin of the patient.
Inventors: |
Howell; Glade H.; (Draper,
UT) ; Christian; Kelly J.; (Draper, UT) ;
Bown; Matthew W.; (West Bountiful, UT) ; Elangovan;
Anthony S.; (Salt Lake City, UT) ; Muse; Jay A.;
(Salt Lake City, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C. R. Bard, Inc. |
Murray Hill |
NJ |
US |
|
|
Family ID: |
55436451 |
Appl. No.: |
16/653576 |
Filed: |
October 15, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14850825 |
Sep 10, 2015 |
10456497 |
|
|
16653576 |
|
|
|
|
62048747 |
Sep 10, 2014 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 15/008 20130101;
A61F 2013/00829 20130101; A61F 13/0203 20130101; A61M 25/02
20130101; A61L 15/26 20130101; A61F 2013/00412 20130101; A61L 15/26
20130101; C08L 75/04 20130101 |
International
Class: |
A61L 15/26 20060101
A61L015/26; A61M 25/02 20060101 A61M025/02; A61F 15/00 20060101
A61F015/00; A61F 13/02 20060101 A61F013/02 |
Claims
1. A dressing for covering a needle-bearing medical device on a
skin surface of a patient, comprising: a substantially flat and
pliable cover film including polyurethane, the cover film
configured to be removably attached to the skin surface of the
patient; and a foam pad disposed atop the cover film, the foam pad
configured to be pierced by the needle-bearing medical device such
that in use the foam pad is positioned between the needle-bearing
medical device and the skin of the patient.
2. The dressing according to claim 1, wherein the foam pad includes
an antimicrobial substance configured to prevent contamination of a
skin insertion site of the needle.
3. A dressing for covering a medical device on a skin surface of a
patient, comprising: a dressing portion configured to rest against
the skin surface of the patient, the dressing portion defining an
opening; and a polymeric cover film attached to the dressing
portion, the polymeric cover film including a pliable domed portion
aligned with the opening, wherein the pliable domed portion: is
configured to receive therein the medical device when the dressing
is placed on the skin surface of the patient, and includes a
perimeter portion attached to the dressing portion, the perimeter
portion including a releasable portion that enables access to an
interior portion of the domed portion after positioning the
dressing on the skin surface of the patient over the medical
device.
4. The dressing according to claim 3, wherein the releasable
portion is resealable to the dressing portion.
5. The dressing according to claim 3, further comprising a pull-tab
to facilitate separation of the releasable portion form the
dressing portion.
6. The dressing according to claim 5, wherein the pull-tab is
positioned and the releasable portion are positioned on a proximal
end of the perimeter portion.
7. The dressing according to claim 6, wherein a distal portion of
the perimeter portion is permanently adhered to the dressing
portion.
8. The dressing according to claim 3, wherein the medical device is
a peripherally inserted central catheter (PICC).
9. The dressing according to claim 3, wherein the pliable domed
portion is collapsible to enable placement of the dressing in a
substantially flat package.
10. The dressing according to claim 3, wherein the pliable domed
portion is formed via a thermal forming process using a mold.
11. The dressing according to claim 10, wherein heat from the
thermal forming process is directed through the opening defined in
the dressing so as to impinge on the polymeric cover film.
12. The dressing according to claim 11, wherein the dressing
portion includes non-woven polyester and wherein the polymeric
cover film includes a thermoplastic polyurethane.
13. The dressing according to claim 3, further comprising a release
liner removably attached to a bottom surface of the dressing
portion, the release liner defining an opening aligned with the
opening of the dressing portion.
14. The dressing according to claim 13, wherein the release liner
provides heat shielding for the dressing portion and the polymeric
cover film during the thermal forming process, and wherein the
pliable domed portion prevents tenting of the dressing when the
dressing is placed over the medical device on the skin surface of
the patient.
15. The dressing according to claim 3, further comprising a support
frame removably attached to the dressing so as to provide rigidity
during placement of the dressing on the skin surface of the
patient.
16. The dressing according to claim 15, wherein the support frame
is removably attached to the polymeric cover film, the support
frame including a cutout portion that enables a securement
component to be attached to the polymeric cover film without
removal of the support frame.
17. The dressing according to claim 16, wherein the securement
component is removably disposed before use on a top surface of the
support frame.
18. The dressing according to claim 17, wherein the securement
component includes a tube securement assembly for securing tubing
of the medical device covered by the dressing.
19. The dressing according to claim 3, wherein the pliable domed
portion is substantially teardrop-shaped.
20. The dressing according to claim 3, wherein the polymeric cover
film includes a thickness proximate an outer perimeter of 2.25
mils, and wherein the pliable domed portion includes a thickness of
from 0.65 mil to 1 mil.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 14/850,825, filed Sep. 10, 2015, now U.S. Pat. No.
10,456,497, which claims the benefit of U.S. Provisional
Application No. 62/048,747, filed Sep. 10, 2014, and titled
"Protective Dressing For Skin-Placed Medical Device," each of which
is incorporated herein by reference in its entirety.
BRIEF SUMMARY
[0002] Briefly summarized, embodiments of the present invention are
directed to a dressing for use in protectively covering a medical
device placed on and/or through the skin surface of a patient.
Examples of such devices include infusion needles for accessing
subcutaneously implanted access ports, catheters of various types
and purposes, insulin infusion needles, etc. When placed atop the
skin-placed medical device, the dressing prevents bacteria and
other undesired microbes or external contaminants from reaching the
medical device and its insertion site through the skin. Further,
the dressing is configured such that water vapor may be transmitted
therethrough, thus enabling the insertion site to breathe and
prevent undesired moisture buildup under the dressing.
[0003] In one embodiment, a dressing for covering a medical device
on a skin surface of a patient is disclosed and comprises a
dressing portion that is configured to rest against a skin surface
of a patient, with the dressing portion defining a hole, and a
polymeric cover film that is at least indirectly attached to the
dressing portion. The cover film includes a pliable domed portion
aligned with the hole of the dressing portion. The pliable domed
portion defines a cavity that configured to receive therein the
medical device when the dressing is placed on the skin of the
patient.
[0004] These and other features of embodiments of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of embodiments of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] A more particular description of the present disclosure will
be rendered by reference to specific embodiments thereof that are
illustrated in the appended drawings. It is appreciated that these
drawings depict only typical embodiments of the invention and are
therefore not to be considered limiting of its scope. Example
embodiments of the invention will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
[0006] FIGS. 1A and 1B are various views of a medical device
dressing according to one embodiment;
[0007] FIG. 2 is a perspective view of a medical device dressing in
place atop a medical device according to one embodiment;
[0008] FIG. 3 is a perspective view of a portion of a medical
device and a dressing according to one embodiment;
[0009] FIGS. 4A and 4B are various views of a medical device
dressing according to one embodiment;
[0010] FIG. 5 shows various views of a plurality of molds used in
forming a medical device dressing according to one embodiment;
[0011] FIGS. 6A-6D are various views of a medical device dressing
according to one embodiment;
[0012] FIG. 7 is an exploded view of the medical device dressing of
FIGS. 6A-6D;
[0013] FIGS. 8A and 8B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0014] FIGS. 9A and 9B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0015] FIGS. 10A and 10B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0016] FIGS. 11A and 11B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0017] FIGS. 12A and 12B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0018] FIGS. 13A and 13B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0019] FIGS. 14A and 14B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0020] FIGS. 15A and 15B show various views of a portion of the
medical device dressing of FIGS. 6A-6D;
[0021] FIG. 16 is a top view of a portion of the medical device
dressing of FIGS. 6A-6D;
[0022] FIGS. 17A-17D show various views depicting placement of the
medical device dressing of FIGS. 6A-6D on a skin surface of a
patient; and
[0023] FIGS. 18A and 18B are various views of a medical device
dressing according to one embodiment.
DETAILED DESCRIPTION OF SELECTED EMBODIMENTS
[0024] Reference will now be made to figures wherein like
structures will be provided with like reference designations. It is
understood that the drawings are diagrammatic and schematic
representations of exemplary embodiments of the present invention,
and are neither limiting nor necessarily drawn to scale.
[0025] For clarity it is to be understood that the word "proximal"
refers to a direction relatively closer to a clinician using the
device to be described herein, while the word "distal" refers to a
direction relatively further from the clinician. For example, the
end of a catheter placed within the body of a patient is considered
a distal end of the catheter, while the catheter end remaining
outside the body is a proximal end of the catheter. Also, the words
"including," "has," and "having," as used herein, including the
claims, shall have the same meaning as the word "comprising."
[0026] Embodiments of the present invention are generally directed
to a dressing for use in protectively covering a medical device
placed on and/or through the skin surface of a patient. Examples of
such devices include infusion needles for accessing subcutaneously
implanted access ports, catheters of various types and purposes,
insulin infusion needles, etc. When placed atop the skin-placed
medical device, the dressing prevents bacteria and other undesired
microbes or external contaminants from reaching the medical device
and its insertion site through the skin. Further, the dressing is
configured such that water vapor may be transmitted therethrough,
thus enabling the insertion site to breathe and prevent undesired
moisture buildup under the dressing.
[0027] In accordance with one embodiment, the dressing is shaped
and configured so as to suitably cover medical devices that extend
some distance above the skin surface without causing deformation,
"tenting," and/or peel-away of the dressing from the skin due to
tension between the dressing surface and the medical device. In
addition, the dressing includes a pliable domed cover that can
cover the medical device, conform to the medical device if
necessary, and deform when contacted so as to enhance patient
comfort, all while providing isolation for the medical device from
potential contaminants. In one embodiment, the domed cover also
assists in securing the medical device in place on the patient
skin.
[0028] Reference is first made to FIGS. 1A and 1B, which show
various views of a dressing for a medical device ("dressing"),
generally designated at 10, according to one embodiment. As shown,
the dressing 10 includes a body 12 that in turn includes a
perimeter portion 14 surrounding a central portion 16. The
perimeter portion 14 provides a barrier and boundary for the
dressing 10 by adhering to the skin of the patient about a medical
device placed on the skin or through the skin via an insertion
site. As such, the perimeter portion 14 includes in the present
embodiment an adhesive 20 on its bottom, skin-contacting surface so
as to easily adhere to the skin surface when placed by a clinician
over a medical device. In another embodiment, the dressing 10 can
be attached to the skin without covering a medical device, such as
in the case of covering a wound, incision, etc.
[0029] In the present embodiment, the perimeter portion 14 includes
a suitably strong yet bendable material such as a non-woven fabric
including polyester or other suitable material. Though shown as
circular, the shape of the perimeter portion 14 can include other
shapes, such as square, oval, triangular, etc.
[0030] The dressing 10 further includes a central portion 16 that
is pliable and breathable so as to enable moisture transfer
therethrough and prevent undesired moisture buildup underneath the
dressing 10. As such, in the present embodiment the central portion
16 includes polyurethane or other suitable thermoplastic or
material that possesses a relatively high moisture vapor transfer
rate ("mvtr") so as to enable suitable moisture transmission
therethrough. In one embodiment, a polyurethane sheet with a
thickness of between about 0.8 mil to about 2 mils is employed for
the central portion 16, though it is appreciated that other sheet
thicknesses of differing moisture vapor transfer rates can be
employed, including low mvtr values.
[0031] In the present embodiment, the central portion 16 is
suitably transparent to enable inspection of the medical
device/insertion site under the dressing 10 to be made from outside
the dressing. Use of a polyurethane central portion provides such
transparency, as do other suitable thermoplastics. In another
embodiment, the central portion 16 is semi-transparent or
opaque.
[0032] FIGS. 1A and 1B further show that the central portion 16 of
the dressing 10 includes a pliable, domed portion 18 that is raised
with respect to the surrounding portions of the dressing. The
raised nature of the domed portion 18 defines a cavity 24 under the
domed portion that can be occupied by the infusion needle or other
medical device when the dressing 10 is placed over the device. This
enables the dressing 10 to suitably cover and isolate the infusion
needle disposed beneath the central portion 16 without significant,
undesired deformation of the dressing, which is common in known
dressings. Such undesired deformation of the dressing includes
"tenting," in which the dressing is deformed into a pointed or
spiked configuration, which causes a separation force that can
result in the pulling away of the perimeter of the adhesively
adhered dressing from engagement with the skin, thus possibly
compromising the isolating nature of the dressing and providing an
undesired entry pathway for microbes into the dressing interior.
Tenting is thus an example of undesired dressing deformations that
are prevented by virtue of the three-dimensionally raised nature of
the domed portion 18 of the present dressing 10.
[0033] Because it is manufactured from the pliable material of the
central portion 16, the domed portion 18, though given a raised
configuration so as to extend away from the patient skins, is
collapsible in this and other embodiments as to increase patient
comfort.
[0034] As part of the central portion 16, the domed portion 18 in
the present embodiment includes the same material as the central
portion (such as polyurethane), though in other embodiments the
domed portion can include a material that differs from other
portions of the dressing 10, including the central portion.
Further, in the present embodiment the underside of the regions of
the central portion 16 that surround the domed portion include the
adhesive 20 (as does the underside of the perimeter portion 14) so
as to adhere to the skin when the dressing 10 is placed thereon,
while the domed portion 18 includes no such adhesive so it can
remain raised from the skin surface and not interfere with the
medical device. In other embodiments, the configuration of adhesive
application can vary, such as the application of adhesive to the
underside of the domed portion 18 so as to adhere the domed portion
to the medical device it covers. It is also appreciated that one or
more antimicrobial agents can be applied to the underside or other
suitable portions of the dressing so as to prevent the formation of
microbes. In one embodiment, the antimicrobial agent can include
silver, chlorhexidine gluconate ("CHG"), isopropyl alcohol ("IPA"),
etc. Further details regarding antimicrobial agents that may be
used according to one embodiment are found in U. S. Patent
Application Publication No. 2013/0110025, filed Jul. 4, 2011, and
entitled "Dressing Device for Use with a Cannula or a Catheter,"
which is incorporated herein by reference in its entirety.
[0035] As seen in FIGS. 1A and 1B, the domed portion 18 is shaped
in one embodiment to correspond to the shape of a medical device,
such as a particular infusion set, that is placed on the skin to be
covered by the dressing 10. In the illustrated embodiment, for
instance, the domed portion 18 includes indentations 26 to conform
to a particular shape of an infusion set having a raised central
hub. It is appreciated that the particular size, shape, and other
configuration of the domed portion 18 can vary from what is shown
and described herein. Further, the domed portion can be shaped to
define a hemispherical cavity or other three-dimensional volume,
including square, triangular, oval, oblong, and various other
geometric and non-geometric shapes. As such, the term "domed
portion" is understood to include a variety of shapes as formed by
the pliable material of the central portion of the dressing,
described above.
[0036] FIGS. 1A and 1B further show that the dressing 10 includes
release liners 22 that protect the adhesive underside of the
dressing and that are removed by the user before placing the
dressing on the patient's skin. The domed portion 18 further
defines a convergence, or point 28, in the present embodiment. The
point 28 provides a visual cue for the clinician so as to place the
dressing at a desired orientation on the skin of the patient. The
point 28 further gives the dome portion a teardrop-shaped
perimeter, in one embodiment. In the present embodiment, for
instance, the point 28 corresponds with the direction of extension
of the infusion set tubing from the infusion set. The tubing can
then extend under the perimeter portion 14 where the adhesive on
the underside of the perimeter portion seals about the tubing to
isolate the cavity 24 of the domed portion 18.
[0037] FIG. 2 shows a dressing 10 according to one embodiment, in
place atop a medical device that in turn is placed atop a skin
surface of a patient. The medical device on the illustrated
embodiment is a ported IV catheter 40, though many other medical
devices could be used with the dressing 10. As shown and because of
its raised domed portion 18, the central portion 16 of the dressing
18 does not undesirably tent up so as to pull the perimeter portion
14 away from the skin 30 of the patient. Note that the tubing 42 of
the catheter 40 is aligned with the point 28 of the domed portion
18 to further prevent undesired tenting of the central portion 16.
Note also that the size, shape, color, placement, and other
configuration aspects of the dressing can vary from what is shown
and described herein while still residing within the principles of
the present disclosure.
[0038] It is appreciated that the shape, size, and configuration of
the domed portion 18 of the dressing 10 and other dressing
described herein can be modified as needed to cover differing types
and sizes of infusion needles, catheters, infusion pumps, and other
medical devices. As such, each domed portion can be uniquely shaped
to fit over the corresponding infusion set/medical device. In
another embodiment, the domed portion is universally sized to fit a
variety of infusion needles or other medical devices. Of course,
the particular shapes and sizes of the domed portion 18 can vary
from what is shown and described herein. In yet another embodiment,
the dressing can include more than one domed portion to cover
multiple medical devices placed on the patient's skin.
[0039] FIG. 3 depicts a dressing 50 according to one embodiment,
including a pliable, film-like body 52 including polyurethane or
other suitable material, and a foam pad 54 disposed atop the body.
In the present embodiment, the foam pad 54 is attached to the top
surface of the dressing body 52 via adhesive or the like. The foam
pad 54 can carry an antimicrobial substance, such as CHA, IPA, etc.
An infusion needle assembly 32 is shown with a needle 34 thereof
penetrating the foam pad 54 and body 52 of the dressing 50 when the
dressing has been placed on the patient skin prior to insertion of
the infusion needle. The dressing 50 thus covers and protects the
skin insertion site of the needle 36 of the infusion needle
assembly 32.
[0040] FIGS. 4A and 4B depict a dressing 110 according to another
embodiment, including a body 112 that in turn includes a perimeter
portion 114 and a central portion 116. The central portion 116
includes a domed portion 118 shaped to provide an interior cavity
for covering a skin-placed medical device. The perimeter portion
114 includes a polyurethane or other suitable film 119 coupled to
and atop a substantially flat, non-woven or other suitable material
121 to provide sturdiness to the dressing. An adhesive is applied
to an underside of the material 121 so as to enable the dressing
110 to adhere to the skin. A slit 122 is provided to enable tubing
or similar component to extend out of the dressing 110.
[0041] The domed portion 118 is separately formed with respect to
the perimeter portion 114 in the present embodiment, is pliable,
and includes a lip 118A to enable it to be secured via adhesive or
other fixation within a hole defined in the perimeter portion 114.
The domed portion 118 can include shape features 123 that provide
some rigidity and/or reinforcement thereto. Note that, despite its
name, the central portion in this and other embodiments can be
placed in a non-centered location with respect to the dressing
body.
[0042] In one embodiment, it is appreciated that one or more
reinforcement features can extend across the domed portion of the
dressings described herein to provide some rigidity and/or
reinforcement thereto. The reinforcement feature can include, for
instance, an adhesive strip, non-woven material that is bonded to
the domed portion 218, etc.
[0043] Reference is now made to FIGS. 6A-7, which depict a dressing
210 according to another embodiment. As shown, the dressing 210
including a body 212 that in turn includes a perimeter portion 214
and a central portion 216. The central portion 216 includes a domed
portion 218 shaped to define an interior cavity 224 for covering a
skin-placed medical device. As best seen in FIG. 6B, the domed
portion includes a point 228 for providing adequate space in the
cavity 224 for an infusion needle assembly or other medical device
to be disposed therein and to assist in indicating to the clinician
in which direction the tubing of the infusion needle assembly
should extend.
[0044] In the present embodiment, the dressing 210 includes a
plurality of layers as will be further described below. As seen in
FIGS. 6C and 7, 8A, and 8B, a release liner 250 is included on the
bottom of the dressing 210 (from the perspective shown in FIG. 7)
that prevents undesired adhesion of the dressing to another surface
prior to placement thereof on the skin of the patient. The release
liner 250 in the present embodiment includes a super-calendered 50
weight craft paper with a silicone coating thereon, though other
suitable materials can also be acceptably used, including other
papers, polymeric materials, etc.
[0045] The release liner 250 includes a hole 270 defining a shape
corresponding to domed portion 218. A first notch 271 is included
at the side edge of the release liner 250, while a second notch 272
is included in the release liner proximate the portion of the hole
270 corresponding to the point 228 of the domed portion 218.
Generally, the shape of the release liner 250 and the position and
configuration of the above-named aspects of the release liner are
supportive of other dressing components, as discussed below.
[0046] A dressing portion 252 is included to serve as a base for
the dressing 210 when placed on the skin of the patient and to
provide a skin-based barrier to protect the insertion site of the
infusion needle or other medical device to be covered by the
dressing. As seen in FIGS. 7, 9A, and 9B, the dressing 252 includes
a flat, flexible body that defines a hole 280, which is aligned
with, and defines a perimeter that corresponds with, both the hole
270 of the release liner 250 and the domed portion 218. A notch 282
is included and corresponds in position with the second notch 272
of the release liner 250. The dressing also defines flat sides 284,
though it is appreciated that the dressing portion 252 can include
any one of a variety of shapes and sizes to accommodate a variety
of dressing applications.
[0047] In the present embodiment, the dressing portion 252 includes
a non-woven, spunlace polyester material, though it is appreciated
that various other materials can be acceptably used. For instance,
a knitted polyester could be employed. Desired characteristics for
the dressing material include one that can suitably carry the
adhesives disposed thereon (discussed below), offers suitable
tensile and general strength for retaining the infusion needle
assembly and its tubing without tearing and for supporting the
domed portion 218, and suitably prevents rolling of the cover film,
discussed below.
[0048] The bottom surface of the dressing portion 252 includes an
adhesive configured to bond the dressing portion to the skin of the
patient when the dressing 210 is placed. Though various
biocompatible adhesives may be used, in the present embodiment an
acrylic adhesive, such as LOCTITE.RTM. 737NA acrylic adhesive, is
employed for the bottom surface of the dressing portion 252. Other
possible adhesives include silicone-based, urethane-based, and
hydrocolloid adhesives.
[0049] A cover film 254 is included atop the dressing portion 252
to provide a cover for the infusion needle assembly or other
skin-placed medical device to be covered by the dressing 210. As
seen in FIGS. 7, 10A, and 10B, the cover film 254 includes a
flexible body that defines a flat perimeter about the domed portion
218, which is also defined by the cover film. The cover film 254
defines a notch 292 that corresponds in position with both the
notch 282 of the dressing portion 252 and the second notch 272 of
the release liner 250. The notch 292, together with the notch 282,
provides an exit site for the tubing of an infusion needle assembly
or other medical device covered by the dressing 210, as will be
seen. Like the dressing portion 252, the cover film 254 includes
flat sides 294, which correspond with the flat sides 284 of the
dressing portion 252, though it is appreciated that the cover film
254 can include any one of a variety of shapes and sizes to
accommodate a variety of dressing applications.
[0050] In greater detail and as has been described in connection
with other embodiments, the pliable domed portion 218 and its point
228 are defined by a raised central portion of the otherwise flat
cover film 254 to define the cavity 224 for protecting and
isolating the skin-placed medical device, though it is appreciated
that the domed portion could be located in other positions on the
dressing 210 as well. The particular size, shape, and configuration
of the domed portion 218 can vary from what is shown and described
herein. The domed portion 218 illustrated in FIGS. 7, 10A, and 10B,
for instance, is configured to cover various types of skin-placed
infusion needle assemblies. The pliable nature of the domed portion
218 enables it to be collapsed during packaging and before use,
then easily expanded up to define the cavity 224 when the dressing
210 is ready to be placed atop the medical device on the skin
surface of the patient.
[0051] In the present embodiment, the cover film 254 includes a
thermoplastic polyurethane film, such as ARGOMEDPLUS.RTM. 18411
polyurethane material available from Argotec LLC of Greenfield,
Mass., though other suitable materials, including other polymeric
materials, could be utilized. Desired characteristics of the
material for film cover 254 in one embodiment include: suitably
high resilience to deformation/elongation; sufficient vapor
transmissiveness; and abrasion, puncture and tear resistance. The
thickness of the thermoplastic polyurethane film to be used in
manufacturing the cover film 254 is about 2.25 mils, in one
embodiment, though the thickness can vary according to the material
selected. In another embodiment, the thickness of the thermoplastic
polyurethane film is from about 1.5 to about 2.5 mils.
[0052] The use of polyurethane as the cover film material enables
the domed portion 218 to be pliable while retaining sufficient
strength to form its dome shape. Further, the above-described
thicknesses of the polyurethane cover film material enables the
dome portion 218 to retain a desired moisture vapor transfer rate
therethrough. This in turn prevents undesired moisture buildup
within the cavity 224 of the domed portion 218 during use of the
dressing 210 on the skin surface of the patient. The domed portion
218, together with the other portions of the dressing 210 cooperate
to isolate the skin-placed medical device over which the dressing
is disposed so as to prevent the incursion of microbes into the
cavity 224 of the domed portion, thus preventing
infection/compromise of the insertion site of the medical device
through the skin of the patient.
[0053] An acrylic adhesive or other suitable adhesive is employed
between the top surface of the dressing 252 and the bottom surface
of the cover film 254 (from the perspective shown in FIG. 7) so as
to prevent separation of the two components.
[0054] A support frame 256 is included to provide stiffness before
and during placement of the dressing 210 over the skin-placed
medical device and the skin of the patient. As seen in FIGS. 6,
11A, and 11B, the support frame 256 includes a flat, flexible body
that includes a hole 300 such that the body generally defines a
horseshoe shape. A cutout 302 is included to enable application of
a securement component to the dressing 210 during dressing
application. Cutouts 304 are also included on a first support
portion 306 of the support frame 256 to help enable removal of a
securement component, such as a tube securement assembly 260, which
is mounted thereon, as will be described further below. A second
support portion 308 is also included on the support frame 256 to
provide a mounting surface for a tape strip 264, a date/time strip
262, and/or other component of the dressing 210, as will be seen
further below.
[0055] A slit 310 is provided on the second support portion 308 to
assist in removal of the afore-mentioned tape strip 264, as will be
seen. Also, a hole 312 is included adjacent the date/time strip 262
to assist with removal of the date/time strip from the support
frame 256, as will be seen. Similar holes can be positioned at
other locations on the support frame to assist with the removal of
other components removably attached to the support frame, in other
embodiments. In yet another embodiment, slits in the support frame
can be positioned proximate or under the date/time strip or other
removable component so as to promote folding of the support frame
and ease removal of the date/time strip from the support frame.
[0056] In the present embodiment, the support frame 256 includes a
super-calendered kraft paper, though it is appreciated that other
materials can also be employed, including polymers including
polyethylene, polypropylene, polystyrene, etc. A silicone or other
suitable coating is added to the top surface of the support frame
256 in the present embodiment to enable ease of removal of the tube
securement assembly 260, date/time strip 262, and the tape strip
264 from the support frame. In the present embodiment, a suitable
adhesive, such as a hot-melt adhesive, is applied to permit the
attachment of the support frame to the cover film 254 and to permit
separation thereof when desired. In one embodiment, the support
frame material is pre-attached to the cover film material prior to
assembly of the dressing 210. Other suitable support frame
adhesives may also be employed.
[0057] FIGS. 7, 12A, and 12B show that the tube securement assembly
260 includes a body including a dressing portion 260A and a cover
film portion 260B that are adhesively or otherwise joined to one
another. In the present embodiment, the dressing portion 260A
includes a non-woven, spunlace polyester material similar to that
of the dressing portion 252, while the cover film portion 260B
includes thermoplastic polyurethane film, such as ARGOMEDPLUS.RTM.
18411 polyurethane material, similar to that of the cover film 254.
Of course, other suitable materials can be employed. Though various
biocompatible adhesives may be used, in the present embodiment an
acrylic adhesive, such as LOCTITE.RTM. 737NA acrylic adhesive, is
included on the bottom surface of the dressing portion 260A of the
tube securement assembly 260 to enable it to be applied to the
dressing 210 and the skin of the patient, as will be discussed.
[0058] A notch 322 is defined in the body of the tube securement
assembly 260 and corresponds in position with a corresponding notch
on the support frame 256 and the notch 271 on the release liner
250. FIGS. 13A, 13B show that a removable support frame portion
324, including a kraft paper or other suitably stiff material, is
applied to a portion of the top surface of the body of the tube
securement assembly 260 to provide increased rigidity during
placement of the tube securement assembly, discussed below.
[0059] The tube securement assembly 260 is removably applied to the
top surface of the support frame 256 on the first support portion
306 thereof, as shown in FIG. 6B. Note that the size, shape, and
placement of the tube securement assembly can vary from what is
shown and described herein.
[0060] FIGS. 14A and 14B show that the date/time strip
262--including a non-woven polyester, gauze, fabric, or other
suitable material--is removably disposed on the top surface of the
support frame 256 on the second support portion 308 thereof, as
shown in FIG. 6B. A date/time insignia 328, or other insignia, is
disposed on the top surface of the date/time strip 262 to enable
data regarding placement of the medical device and/or dressing 210
to be recorded.
[0061] FIGS. 15A and 15B show that the elongate adhesive tape strip
264 is removably disposed on the top surface of the support frame
256 on the second support portion 308 thereof, proximate the
date/time strip 262, as shown in FIG. 6B. The tape strip 264 can be
used to further secure the skin-placed medical device by applying
the tape strip over the domed portion 218, to further securing the
tubing of the medical device by applying the tape strip over the
tube securement assembly 260, to secure the medical device to the
skin before placement of the dressing, or to assist in other ways
with placement of the dressing 210 on the skin of the patient. Note
that the slit 310 included on the support frame 256 (FIGS. 11A,
11B) assists in removing the tape strip 264 from the support frame.
In brief, the relatively small portion of the support frame 256
above the slit 310 is ripped off with the tape strip 264 when the
tape strip is removed from the support frame, which provides a
non-adhesive location on the tape strip to enable the clinician to
easily handle the tape strip. Once the tape strip 264 has been
placed, the ripped-off portion of the support frame 256 can be
removed from the back of the tape strip, and discarded.
[0062] FIG. 16 shows that the release liner 250 in the present
embodiment includes two extended surfaces, or underhang portions
340, on either end of the dressing 210, which assist the user in
grasping and removing the release liner from the rest of the
dressing 210 during placement on the skin of the patient. Also
shown in FIG. 16 are the two cutouts 304 for assisting the user in
grasping and removing the tube securement assembly 260 from the
support frame 256. The cutouts 304 are located in an interior
position of the dressing 210 as opposed to being located on an
outer edge of the dressing, which enables the user to more easily
remove the tube securement assembly 260 from the support frame 256
with one hand. Thus, together with the right overhang 340 shown in
FIG. 16, the cutouts 304 provide three access points for the user
to peel away the tube securement assembly 260 from the support
frame 256. Such cutouts can be employed in other areas of the
dressing, in other embodiments.
[0063] Reference is now made to FIGS. 17A-17D in describing details
relating to the placement of the dressing 210 on the skin of the
patient over a skin-placed medical device, according to the present
embodiment. Note that the dressing 210 in one embodiment is first
removed from a sterilized package using suitable sterilization
techniques. The release liner 250 is peeled off the back of the
dressing 210, using the extended underhang portions 340 (FIG. 16)
to help grab the release liner.
[0064] Once the release liner 250 has been removed, the dressing
210 is placed over a medical device disposed on the skin of the
patient, such as the infusion needle assembly 32 shown in FIG. 17B.
The dressing 210 is pressed down so as to be affixed to the skin
surface of the patient, taking care to orient the dressing such
that the infusion needle assembly 32 is received within the cavity
224 of the teardrop-shaped domed portion 218 and the point 228 of
the domed portion is substantially aligned with tubing 34 of the
infusion needle assembly and the tubing extends through the notch
282, 292 of the joined dressing portion 252 and cover film 254. The
dressing 210 is pressed downward so that the adhesive on the bottom
surface of the dressing portion 252 adheres to the skin and around
the tubing extending under the dressing portion, noting that no
adhesive is present on the domed portion 218. The dressing 210 is
secured such that the infusion needle assembly 32 is isolated
within the dressing, thus protecting it from contamination,
incursion of microbes, etc. In one embodiment, the domed portion of
the dressing engages a top portion of the infusion needle assembly
or other medical device so as to help maintain the medical device
in position on the skin of the patient.
[0065] The tube securement assembly 260 is then removed from atop
the support frame 256 and placed over the portion of the tubing 34
that extends from the notches 282, 292 so as to overlap both the
skin of the patient and the adjacent portion of the dressing 210
and such that the notch 322 receives a portion of the tubing
therein, as seen in FIG. 17C. The support frame portion 324
provided added rigidity to help handle and place the tube
securement assembly 260 in its desired position. After placement,
the support frame portion 324 can be peeled away from the tube
securement assembly 260 and discarded. In this way, the tubing 34
is further secured against unintended displacement and is further
isolated so as to prevent migration of impurities into the cavity
224 of the domed portion 218 and the infusion needle assembly 32
disposed therein. Further, placement of the tube securement
assembly 260 in this manner prevents the tubing 34 from lifting up
the edge of the dressing 210 (and thus compromising the isolation
of the infusion needle assembly 32) should a pulling force be
applied to the tubing. Note that the cutout 302 of the support
frame 256 enables the tube securement assembly to be placed on the
dressing 210 without first having to remove the support frame.
[0066] It is appreciated that in one embodiment the tube securement
assembly is integrally formed with the dressing body; in another
embodiment, no tube securement assembly is included. The size,
shape, configuration, and placement of the tube securement assembly
can also vary from what is shown and described herein. In another
embodiment the securement assembly is used to secure components
other than tubing. For instance, the securement assembly can be
used to secure the dressing itself, in one embodiment.
[0067] Once the tube securement assembly 260 has been positioned,
the support frame can then be removed from the dressing 210, as
shown in FIG. 17C, resulting in the dressing placement shown in
FIG. 17D. If desired, the date/time strip 262 can be peeled away
from the recently-removed support frame 256, using the hole 312
that allows a finger of the user to grasp the bottom surface of the
date/time strip. The date/time strip 262 can then be placed on the
cover film 254 of the dressing 210, the tube securement assembly
260, or in another suitable location. Also if needed, the tape
strip 264 can be removed from the support frame 256 and utilized on
the dressing 210, as already described further above.
[0068] It is appreciated that, in one embodiment, no support frame
is included in the dressing. In such a case, the release liner can
optionally be made relatively thicker to provide for the desired
stiffness of the dressing.
[0069] The dressing 210 is manufactured in one embodiment by first
joining the dressing portion 252 to cover film 254. In particular,
an adhesive (described further above) is applied to the top surface
of the dressing portion 252 and the cover film 254, with the
support frame 256 pre-attached thereto, is attached to the dressing
portion. At this stage, the domed portion 218 has not yet been
defined in the cover film 254.
[0070] The dressing portion 252 and joined cover film 254 can be
pre-cut to define the respective sides 284, 294, or be cut after
being joined together. The release liner 250 can then be joined to
the bottom surface of the dressing portion 252. The holes 270, 280
of the respective release liner 250 and dressing portion 252 can be
pre-defined or defined after joining of the release liner and the
dressing portion. Excess material about the support frame 256 can
be removed at this time, in the present embodiment.
[0071] The pre-assembled tube securement assembly 260 can be
attached to the top surface of the support frame 256, as can the
date/time strip 262 and the tape strip 264. Note that, in one
embodiment, the final shapes of the tube securement assembly 260,
the date/time strip 262, and the tape strip 264 can be defined at
this stage via a die cut procedure. In another embodiment, the
final shapes of these components can be pre-defined prior to
attachment to the support frame 256.
[0072] Next, the assembled dressing 210 is electrostatically
neutralized via an ionizer to eliminate static electricity before
being introduced to a thermal forming process, wherein the dressing
is positioned such that the holes 270 and 280 of the release liner
250 and the dressing portion 252 are aligned with a negative-type
mold. A vacuum is applied and heat is introduced to the dressing so
that the central portion of the cover film 254 is sucked on to and
thermally formed about the mold, thus defining the pliable domed
portion 218 in the cover film 254. In one embodiment, holes are
included in the mold to assist in sucking the cover film on to the
mold surface. Note that the release liner 250 acts as a heat shield
to protect the dressing portion 252 and the cover film 254 from
heat damage during the thermal forming process, in one embodiment.
The heat and vacuum are then removed and the dressing 210 is
allowed to cool, which causes the domed portion 218 to be
permanently defined.
[0073] Note that the mold can be a negative or positive form of the
desired shape for the domed portion 218. Indeed, FIG. 5 shows
various examples of positive molds 70A-70E, each including a shaped
body 72. Note also that the shapes of the molds can vary from what
is shown and described herein. In one embodiment, a positive air
pressure could be employed to force the cover film on to the mold
surface.
[0074] When forming the domed portion in the above-described manner
utilizing a polyurethane cover film 254 of about 2 mils thickness
as detailed further above, the thickness of the resultant domed
portion 218 is from about 0.65 mil to about 1 mil, in one
embodiment.
[0075] In other embodiments, other modes for forming the domed
portion can be employed, including cold forming (rolling),
injection molding, utilizing a pre-formed cover film, and dip
casting, in which a form is repeatedly dipped into a molten
polyurethane (or other suitable material) and solvent mixture to
build up a domed portion cover film. These and other forming
techniques are therefore contemplated. It is also appreciated that
the above-described manufacturing steps are not exhaustive and that
a different order of steps could be employed.
[0076] FIGS. 18A and 18B depict a dressing 410 according to one
embodiment, including a body 412 defined by a flexible, flat
perimeter portion 414 that surrounds a central portion 416 as in
previous embodiments. The central portion 416 includes a pliable
domed portion 418 of polyurethane or other suitable material.
[0077] A releasable portion 416A included about a proximal
perimeter of the central portion 416 is configured to be resealable
so that access can be selectively made to the PICC 315 or other
medical device enclosed within the domed portion 418. A pull-tab
419 or the like is included to facilitate lifting of the proximal
portion of the central portion 416. When closed, the releasable
portion 416A adheres to a releasable adhesive included on the
perimeter portion 414 directly below the releasable portion,
indicated in FIGS. 15A and 15B as a release layer portion 414A, so
as to maintain isolation of the domed portion 418 when closed.
[0078] Correspondingly, an adhered portion 416B is included about a
distal perimeter of the central portion 416 and is configured to
not separate from attachment with the perimeter portion 414. The
adhesive used to secure the adhered portion 416B to the perimeter
portion 414 can be the same adhesive as an adhesive 420 that is
employed to secure the other portions of the central portion 416 to
the perimeter portion 414. The relative sizes, shapes, and extents
of both the releasable portion 416A and the adhered portion 416B
can be varied from what is shown and described herein. A slit 422
can be included in the perimeter portion 414 to enable removal of
the dressing 410 from over the medical device. As in other
embodiments, the domed portion 418 can include a notch, or point
428, to fit over a portion of the covered medical device.
[0079] Embodiments of the invention may be embodied in other
specific forms without departing from the spirit of the present
disclosure. The described embodiments are to be considered in all
respects only as illustrative, not restrictive. The scope of the
embodiments is, therefore, indicated by the appended claims rather
than by the foregoing description. All changes that come within the
meaning and range of equivalency of the claims are to be embraced
within their scope.
* * * * *