U.S. patent application number 16/287862 was filed with the patent office on 2019-06-27 for hybrid sealing tape.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Timothy Mark ROBINSON.
Application Number | 20190192750 16/287862 |
Document ID | / |
Family ID | 51869030 |
Filed Date | 2019-06-27 |
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United States Patent
Application |
20190192750 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
June 27, 2019 |
Hybrid Sealing Tape
Abstract
A dressing for treating a tissue site with negative pressure is
described. The dressing includes a tissue interface and a sealing
member. The dressing further includes a sealing tape configured to
be coupled to the sealing member and epidermis. The sealing tape
includes a bonding adhesive and a sealing adhesive coupled to a
side of the sealing tape. The sealing tape includes a layer of the
bonding adhesive disposed on a film layer and a layer of sealing
adhesive having one or more apertures disposed on the bonding
adhesive. The sealing tape can include a layer of the bonding
adhesive disposed on a portion of a film layer and a layer of the
sealing adhesive disposed on a uncovered portions of the film
layer.
Inventors: |
LOCKE; Christopher Brian;
(Bournemouth, GB) ; ROBINSON; Timothy Mark;
(Shillingstone, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
51869030 |
Appl. No.: |
16/287862 |
Filed: |
February 27, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14517521 |
Oct 17, 2014 |
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16287862 |
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61896582 |
Oct 28, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
Y10T 156/10 20150115;
A61F 13/0216 20130101; A61M 1/0088 20130101; A61F 13/025 20130101;
A61F 13/0269 20130101; A61F 13/0246 20130101; A61L 15/58 20130101;
B32B 37/1292 20130101; A61M 2207/00 20130101; A61F 13/00068
20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61L 15/58 20060101 A61L015/58; A61F 13/02 20060101
A61F013/02; A61F 13/00 20060101 A61F013/00; B32B 37/12 20060101
B32B037/12 |
Claims
1-28. (canceled)
29. A method for sealing a tissue site, the method comprising:
disposing a tissue interface adjacent to the tissue site; covering
the tissue interface with a drape and sealing the drape to tissue
adjacent to the tissue site to form a sealed space; and coupling a
sealing tape to the drape and to epidermis, the sealing tape each
comprising a bonding adhesive configured to form a bonding coupling
and a sealing adhesive configured to form a sealing coupling.
30. The method of claim 29, further comprising coupling the sealing
tape over edges of the drape so that each sealing tape is partially
coupled to the epidermis and partially coupled to the drape.
31. The method of claim 29, further comprising: coupling the
sealing tape to the epidermis adjacent to the tissue interface to
form a window; and coupling the drape to the sealing tape to cover
the window so that the sealing tape is between the drape and the
epidermis.
32-52. (canceled)
53. The method of claim 29, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive; and the
sealing adhesive is coupled to the bonding adhesive, the sealing
adhesive having portions removed to form a first pattern and expose
the bonding adhesive through the sealing adhesive in a second
pattern.
54. The method of claim 29, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive; and the
bonding adhesive and the sealing adhesive comprise an adhesive
layer comprising: the sealing adhesive disposed on a first portion
of the film layer in a first pattern, and the bonding adhesive
disposed on a second portion of the film layer in a second pattern,
the second pattern registered with the first pattern so that the
first portion and the second portion cover substantially different
portions of the film layer.
55. The method of claim 29, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive, wherein
the sealing adhesive forms a first pattern and the bonding adhesive
forms a second pattern.
56. The method of claim 55, wherein the first pattern comprises at
least one row of apertures disposed proximate a center of the
sealing tape and the second pattern comprises remaining portions of
the sealing tape.
57. The method of claim 55, wherein the first pattern comprises at
least two rows of apertures and the second pattern comprises
remaining portions of the sealing tape.
58. The method of claim 56, wherein the rows of apertures are
offset from each other.
59. The method of claim 55, wherein the first pattern comprises a
strip of adhesive disposed proximate a center of the sealing tape
and the second pattern comprises a strip of adhesive adjacent an
edge of the sealing tape.
60. The method of claim 55, wherein the second pattern comprises a
wave pattern extending a length of the sealing tape and the first
pattern comprises the remaining portions of the sealing tape.
61. The method of claim 55, wherein: the first pattern comprises a
first plurality of apertures disposed in a pattern on the sealing
tape and a second plurality of apertures having shapes that are a
portion of shapes of the first plurality of apertures, the second
plurality of apertures disposed adjacent to an edge of the sealing
tape; and the first pattern comprises the remaining portions of the
sealing tape.
62. The method of claim 61, wherein first plurality of apertures
have a circular shape and the second plurality of apertures have a
semi-circular shape.
63. The method of claim 55, wherein the first pattern comprises a
plurality of apertures positioned adjacent to edges of the sealing
tape and the second pattern comprises the remaining portions of the
sealing tape.
64. The method of claim 55 wherein: the first pattern comprises two
strips of adhesive extending a length of the sealing tape, at least
one of the two strips of adhesive disposed adjacent to an edge of
the sealing tape and another of the two strips of adhesive disposed
between the edges of the sealing tape; and the second pattern
comprises the remaining portions of the sealing tape.
65. A dressing for treating a tissue site with negative pressure,
the dressing comprising: a tissue interface configured to be
positioned adjacent to the tissue site; a sealing member configured
to be positioned over the tissue interface and the tissue site to
form a sealed environment; and a sealing tape comprising a bonding
adhesive having a second pattern and a sealing adhesive having a
first pattern, the sealing tape configured to attach the sealing
member to epidermis, wherein the first pattern comprises a strip of
adhesive disposed proximate a center of the sealing tape and the
second pattern comprises a strip of adhesive adjacent an edge of
the sealing tape.
66. The dressing of claim 65, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive; and the
sealing adhesive is coupled to the bonding adhesive, the sealing
adhesive having portions removed to form the first pattern and
expose the bonding adhesive through the sealing adhesive in the
second pattern.
67. The dressing of claim 65, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive; and the
bonding adhesive and the sealing adhesive comprise an adhesive
layer comprising: the sealing adhesive disposed on a first portion
of the film layer in the first pattern, and the bonding adhesive
disposed on a second portion of the film layer in the second
pattern, the second pattern registered with the first pattern so
that the first portion and the second portion cover substantially
different portions of the film layer.
68. A dressing for treating a tissue site with negative pressure,
the dressing comprising: a tissue interface configured to be
positioned adjacent to the tissue site; a sealing member configured
to be positioned over the tissue interface and the tissue site to
form a sealed environment; and a sealing tape comprising a bonding
adhesive having a second pattern and a sealing adhesive having a
first pattern, the sealing tape configured to attach the sealing
member to epidermis, wherein the first pattern comprises two strips
of adhesive extending a length of the sealing tape, at least one of
the two strips of adhesive disposed adjacent to an edge of the
sealing tape and another of the two strips of adhesive disposed
between the edges of the sealing tape; and the second pattern
comprises the remaining portions of the sealing tape.
69. The dressing of claim 68, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive; and the
sealing adhesive is coupled to the bonding adhesive, the sealing
adhesive having portions removed to form the first pattern and
expose the bonding adhesive through the sealing adhesive in the
second pattern.
70. The dressing of claim 68, wherein the sealing tape further
comprises: a film layer coupled to the bonding adhesive; and the
bonding adhesive and the sealing adhesive comprise an adhesive
layer comprising: the sealing adhesive disposed on a first portion
of the film layer in the first pattern, and the bonding adhesive
disposed on a second portion of the film layer in the second
pattern, the second pattern registered with the first pattern so
that the first portion and the second portion cover substantially
different portions of the film layer.
Description
RELATED APPLICATION
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/517,521, filed Oct. 17, 2014, entitled "HYBRID SEALING
TAPE" which claims the benefit, under 35 USC .sctn. 119(e), of the
filing of U.S. Provisional Patent Application Ser. No. 61/896,582,
entitled "HYBRID DRAPE STRIPS," filed Oct. 28, 2013, which is
incorporated herein by reference for all purposes.
FIELD
[0002] The present disclosure relates generally to dressings for
adhering to a patient, and more particularly, but without
limitation, to a hybrid sealing tape having at least two adhesives
disposed thereon.
BACKGROUND
[0003] Clinical studies and practice have shown that reducing
pressure in proximity to a tissue site can augment and accelerate
growth of new tissue at the tissue site. The applications of this
phenomenon are numerous, but it has proven particularly
advantageous for treating wounds. Regardless of the etiology of a
wound, whether trauma, surgery, or another cause, proper care of
the wound is important to the outcome. Treatment of wounds with
negative pressure is commonly referred to as "negative-pressure
therapy," but may also be known by other names, including "negative
pressure wound therapy," "reduced-pressure therapy," and "vacuum
therapy," for example. Negative-pressure therapy may provide a
number of benefits, including migration of epithelial and
subcutaneous tissues, improved blood flow, and micro-deformation of
tissue at a wound site. Together, these benefits can increase
development of granulation tissue and reduce healing times.
[0004] While the clinical benefits of negative-pressure therapy are
widely known, the cost and complexity of negative-pressure therapy
can be a limiting factor in its application, and the development
and operation of negative-pressure systems, components, and
processes continues to present significant challenges to
manufacturers, healthcare providers, and patients.
SUMMARY
[0005] According to an illustrative, non-limiting embodiment, a
dressing for treating a tissue site with negative pressure is
described. The dressing may include a tissue interface configured
to be positioned adjacent to the tissue site. The dressing also may
include a sealing member configured to be positioned over the
tissue interface and the tissue site to form a sealed environment.
The dressing further may include one or more sealing tape
configured to be coupled to the sealing member and epidermis
adjacent to the tissue site. The sealing tape each may have a
bonding adhesive and a sealing adhesive coupled to a side of each
sealing tape.
[0006] According to another illustrative embodiment, a system for
treating a tissue site with negative-pressure is described. The
system may include a manifold configured to be positioned adjacent
to the tissue site and a drape configured to be positioned over the
tissue site and the manifold and configured to seal to tissue
adjacent to the tissue site to form a sealed space. The system also
may include a negative-pressure source configured to provide
negative-pressure to the sealed space. The system further may
include one or more sealing tape configured to be coupled to the
drape and epidermis adjacent to the tissue site. The sealing tape
may each have a bonding adhesive and a sealing adhesive coupled to
a side of each sealing tape.
[0007] According to another illustrative embodiment, a method for
treating a tissue site with negative-pressure is described. A
manifold may be disposed adjacent to the tissue site. The manifold
may be covered with a drape and the drape may be sealed to tissue
adjacent to the tissue site to form a sealed space. A
negative-pressure source may be configured to provide
negative-pressure to the sealed space. One or more sealing tape may
be coupled to the drape and epidermis adjacent to the tissue site.
The sealing tape may each have a bonding adhesive configured to
form a bonding coupling and a sealing adhesive configured to form a
sealing coupling coupled to a side of the sealing tape.
[0008] According to yet another illustrative embodiment, a method
for manufacturing sealing tape for a negative-pressure system is
described. The method provides a film layer and couples a layer of
a bonding adhesive to the film layer. The method couples a layer of
a sealing adhesive to the bonding layer. The method removes
portions of the sealing adhesive to form a first pattern and expose
the bonding adhesive through the sealing adhesive in a second
pattern.
[0009] According to still another illustrative embodiment, a method
for manufacturing sealing tape for a negative-pressure system is
described. A film layer may be provided and a bonding adhesive may
be disposed on a first portion of the film layer in a first
pattern. A sealing adhesive may be disposed on a second portion of
the film layer in a second pattern. The second pattern may be
registered with the first pattern so that the first portion and the
second portion cover substantially different portions of the film
layer.
[0010] Other aspects, features, and advantages of the illustrative
embodiments will become apparent with reference to the drawings and
detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Illustrative embodiments are described in detail below with
reference to the attached drawings, which are incorporated by
reference herein, and wherein:
[0012] FIG. 1A is a schematic diagram (with a portion shown in
elevation) of an illustrative embodiment of a system for treating a
tissue site on a patient with negative pressure that may be
associated with some illustrative embodiments of the system;
[0013] FIG. 1B is a plan view of a portion of the system of FIG.
1A;
[0014] FIG. 2A is a schematic diagram (with a portion shown in
elevation) of another illustrative embodiment of a system for
treating a tissue site on a patient with negative pressure;
[0015] FIG. 2B is a plan view of a portion of the system of FIG.
2A;
[0016] FIG. 3 is an exploded perspective view of a sealing tape
that may be used with some embodiments of the systems of FIG. 1A
and FIG. 2A;
[0017] FIG. 4A is a sectional view of a portion of the sealing tape
of FIG. 3 with sealing couplings;
[0018] FIG. 4B is a sectional view of the portion of the sealing
tape of FIG. 4A with bonding couplings;
[0019] FIG. 5 is an exploded perspective view of a sealing tape
that may be used with the systems of FIG. 1A and FIG. 2A;
[0020] FIG. 6 is a sectional view of a portion of the sealing tape
of FIG. 5 proximate to an epidermis;
[0021] FIG. 7 is a sectional view of the portion of the sealing
tape of FIG. 6 with sealing couplings;
[0022] FIG. 8 is a sectional view of the portion of the sealing
tape of FIG. 6 with bonding couplings; and
[0023] FIG. 9, FIG. 10, FIG. 11, FIG. 12, FIG. 13, FIG. 14, and
FIG. 15 are plan views of illustrative patterns of the sealing tape
of FIG. 3 and FIG. 5.
DETAILED DESCRIPTION
[0024] New and useful systems, methods, and apparatuses associated
with drapes used for regulating pressure are set forth in the
appended claims. Objectives, advantages, and a preferred mode of
making and using the systems, methods, and apparatuses may be
understood best by reference to the following detailed description
in conjunction with the accompanying drawings. The description
provides information that enables a person skilled in the art to
make and use the claimed subject matter, but may omit certain
details already well-known in the art. Moreover, descriptions of
various alternatives using terms such as "or" do not necessarily
require mutual exclusivity unless clearly required by the context.
The claimed subject matter may also encompass alternative
embodiments, variations, and equivalents not specifically described
in detail. The following detailed description should therefore be
taken as illustrative and not limiting.
[0025] The example embodiments may also be described herein in the
context of negative-pressure therapy applications, but many of the
features and advantages are readily applicable to other
environments and industries. Spatial relationships between various
elements or to the spatial orientation of various elements may be
described as depicted in the attached drawings. In general, such
relationships or orientations assume a frame of reference
consistent with or relative to a patient in a position to receive
negative-pressure therapy. However, as should be recognized by
those skilled in the art, this frame of reference is merely a
descriptive expedient rather than a strict prescription.
[0026] FIG. 1A is a sectional view of an example embodiment of a
negative-pressure therapy system 100 illustrating details that may
be associated with some embodiments for treating a tissue site 102
with negative pressure. As shown in the illustrative embodiment of
FIG. 1A, the negative-pressure therapy system 100 may include a
dressing 104 fluidly coupled to a negative-pressure source 106. In
some embodiments, the negative-pressure source 106 may be fluidly
coupled to the dressing 104 by a conduit, such as a tube 112, and a
connector, such as a connector 114. The dressing 104 may generally
include a cover or sealing member, such as a drape 108, and a
tissue interface, such as a tissue interface 110. The drape 108 may
be attached to an epidermis 116. The drape 108 can substantially
prevent the leakage of fluids while allowing vapor to egress
through the drape 108. In some embodiments, the dressing 104 may
include one or more sealing tape 124 coupled to epidermis 116 and
the drape 108.
[0027] In general, components of the negative-pressure therapy
system 100 may be coupled directly or indirectly to each other. For
example, the negative-pressure source 106 may be directly coupled
to the connector 114 and indirectly coupled to the tissue interface
110 through the connector 114. Components may be fluidly coupled to
each other to provide a path for transferring fluids (i.e., liquid
and/or gas) between the components.
[0028] In some embodiments, components may be fluidly coupled with
a tube, such as the tube 112, for example. A "tube," as used
herein, broadly refers to a tube, pipe, hose, conduit, or other
structure with one or more lumina adapted to convey fluids between
two ends. Typically, a tube is an elongated, cylindrical structure
with some flexibility, but the geometry and rigidity may vary. In
some embodiments, components may additionally or alternatively be
coupled by virtue of physical proximity, being integral to a single
structure, or being formed from the same piece of material.
Coupling may also include mechanical, thermal, electrical, or
chemical coupling (such as a chemical bond) in some contexts.
[0029] In operation, a tissue interface, such as the tissue
interface 110, may be placed within, over, on, against, or
otherwise proximate to a tissue site. The drape 108 may be sealed
to undamaged epidermis peripheral to the tissue site. Thus, the
drape 108 can provide a sealed therapeutic environment 118
proximate to the tissue site 102. The sealed therapeutic
environment 118 may be substantially isolated from the external
environment, and the negative-pressure source 106 can reduce the
pressure in the sealed therapeutic environment 118. Negative
pressure applied across the tissue site through a tissue interface
in the sealed therapeutic environment 118 can induce macrostrain
and microstrain in the tissue site 102, as well as remove exudates
and other fluids from the tissue site. The removed exudates and
other fluids can be collected in a container and disposed of
properly.
[0030] The fluid mechanics of using a negative-pressure source to
reduce pressure in another component or location, such as within a
sealed therapeutic environment 118, can be mathematically complex.
However, the basic principles of fluid mechanics applicable to
negative-pressure therapy are generally well-known to those skilled
in the art, and the process of reducing pressure may be described
illustratively herein as "delivering," "distributing," or
"generating" negative pressure, for example.
[0031] In general, exudates and other fluids flow toward lower
pressure along a fluid path. Thus, the term "downstream" typically
implies a position in a fluid path relatively closer to a
negative-pressure source, and conversely, the term "upstream"
implies a position relatively further away from a negative-pressure
source. Similarly, it may be convenient to describe certain
features in terms of fluid "inlet" or "outlet" in such a frame of
reference. This orientation is generally presumed for purposes of
describing various features and components of negative-pressure
therapy systems herein. However, a fluid path may also be reversed
in some applications, such as by substituting a positive-pressure
source for a negative-pressure source, and this descriptive
convention should not be construed as a limiting convention.
[0032] The term "tissue site" in this context broadly refers to a
wound or defect located on or within tissue, including but not
limited to, bone tissue, adipose tissue, muscle tissue, neural
tissue, dermal tissue, vascular tissue, connective tissue,
cartilage, tendons, or ligaments. A wound may include chronic,
acute, traumatic, subacute, and dehisced wounds, partial-thickness
burns, ulcers (such as diabetic, pressure, or venous insufficiency
ulcers), flaps, and grafts, for example. The term "tissue site" may
also refer to areas of tissue that are not necessarily wounded or
defective, but are instead areas in which it may be desirable to
add or promote the growth of additional tissue. For example,
negative pressure may be used in certain tissue areas to grow
additional tissue that may be harvested and transplanted to another
tissue location. In some embodiments, the tissue site 102 may be a
wound that extends through the epidermis 116, through a dermis 120,
and into subcutaneous tissue 122.
[0033] "Negative pressure" generally refers to a pressure less than
a local ambient pressure, such as the ambient pressure in a local
environment external to the sealed therapeutic environment 118
provided by the drape 108. In many cases, the local ambient
pressure may also be the atmospheric pressure at which a tissue
site is located. Alternatively, the pressure may be less than a
hydrostatic pressure associated with tissue at the tissue site.
Unless otherwise indicated, values of pressure stated herein are
gauge pressures. Similarly, references to increases in negative
pressure typically refer to a decrease in absolute pressure, while
decreases in negative pressure typically refer to an increase in
absolute pressure.
[0034] A negative-pressure source, such as the negative-pressure
source 106, may be a reservoir of air at a negative pressure, or
may be a manual or electrically-powered device that can reduce the
pressure in a sealed volume, such as a vacuum pump, a suction pump,
a wall-suction port available at many healthcare facilities, or a
micro-pump, for example. A negative-pressure source may be housed
within or used in conjunction with other components, such as
sensors, processing units, alarm indicators, memory, databases,
software, display devices, or operator interfaces that further
facilitate negative-pressure therapy. While the amount and nature
of negative pressure applied to a tissue site may vary according to
therapeutic requirements, the pressure is generally a low vacuum,
also commonly referred to as a rough vacuum between -5 mm Hg (-667
Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges are
between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
[0035] The tissue interface 110 can be generally adapted to contact
a tissue site. The tissue interface 110 may be partially or fully
in contact with the tissue site. If the tissue site is a wound, for
example, the tissue interface 110 may partially or completely fill
the wound, or may be placed over the wound. The tissue interface
110 may take many forms, and may have many sizes, shapes, or
thicknesses depending on a variety of factors, such as the type of
treatment being implemented or the nature and size of a tissue
site. For example, the size and shape of the tissue interface 110
may be adapted to the contours of deep and irregular shaped tissue
sites.
[0036] In some embodiments, the tissue interface 110 may be a
manifold. A "manifold" in this context generally includes any
substance or structure providing a plurality of pathways adapted to
collect or distribute fluid across a tissue site under negative
pressure. For example, a manifold may be adapted to receive
negative pressure from a source and distribute the negative
pressure through multiple apertures across a tissue site, which may
have the effect of collecting fluid from across a tissue site and
drawing the fluid toward the source. In some embodiments, the fluid
path may be reversed or a secondary fluid path may be provided to
facilitate delivering fluid across a tissue site.
[0037] In some illustrative embodiments, the pathways of a manifold
may be channels interconnected to improve distribution or
collection of fluids across a tissue site. For example, cellular
foam, open-cell foam, reticulated foam, porous tissue collections,
and other porous material such as gauze or felted mat generally
include pores, edges, and/or walls adapted to form interconnected
fluid pathways. Liquids, gels, and other foams may also include or
be cured to include apertures and flow channels. In some
illustrative embodiments, a manifold may be a porous foam material
having interconnected cells or pores adapted to distribute negative
pressure across a tissue site. The foam material may be either
hydrophobic or hydrophilic. In one non-limiting example, a manifold
may be an open-cell, reticulated polyurethane foam such as
GranuFoam.RTM. dressing available from Kinetic Concepts, Inc. of
San Antonio, Tex.
[0038] In an example in which the tissue interface 110 may be made
from a hydrophilic material, the tissue interface 110 may also wick
fluid away from a tissue site, while continuing to distribute
negative pressure to the tissue site. The wicking properties of the
tissue interface 110 may draw fluid away from a tissue site by
capillary flow or other wicking mechanisms. An example of a
hydrophilic foam is a polyvinyl alcohol, open-cell foam such as
V.A.C. WhiteFoam.RTM. dressing available from Kinetic Concepts,
Inc. of San Antonio, Tex. Other hydrophilic foams may include those
made from polyether. Other foams that may exhibit hydrophilic
characteristics include hydrophobic foams that have been treated or
coated to provide hydrophilicity.
[0039] The tissue interface 110 may further promote granulation at
a tissue site when pressure within the sealed therapeutic
environment 118 is reduced. For example, any or all of the surfaces
of the tissue interface 110 may have an uneven, coarse, or jagged
profile that can induce microstrains and stresses at a tissue site
if negative pressure is applied through the tissue interface
110.
[0040] In some embodiments, the tissue interface 110 may be
constructed from bioresorbable materials. Suitable bioresorbable
materials may include, without limitation, a polymeric blend of
polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric
blend may also include without limitation polycarbonates,
polyfumarates, and capralactones. The tissue interface 110 may
further serve as a scaffold for new cell-growth, or a scaffold
material may be used in conjunction with the tissue interface 110
to promote cell-growth. A scaffold is generally a substance or
structure used to enhance or promote the growth of cells or
formation of tissue, such as a three-dimensional porous structure
that provides a template for cell growth. Illustrative examples of
scaffold materials include calcium phosphate, collagen, PLA/PGA,
coral hydroxy apatites, carbonates, or processed allograft
materials.
[0041] The drape 108 is an example of a sealing member. A sealing
member may be constructed from a material that can provide a fluid
seal between two environments or components, such as between a
therapeutic environment and a local external environment. A sealing
member may be, for example, an impermeable or semi-permeable,
elastomeric film or barrier that can provide a seal adequate to
maintain a negative pressure at a tissue site for a given
negative-pressure source. For semi-permeable materials, the
permeability generally should be low enough that a desired negative
pressure may be maintained. Generally, a drape suitable for
covering a tissue site for negative-pressure therapy may comprise a
film having a thickness between about 25 microns and about 50
microns that is water-vapor permeable and formed of a polymer. The
film, often formed of polyurethane, may be coated with an adhesive
having a coating weight between about 25 gsm and about 65 gsm. The
adhesive may often be acrylic-based and pressure sensitive. A
pressure-sensitive adhesive increases in bond strength when pressed
against the surface to which the adhesive is being bonded. In some
applications, a pressure-sensitive adhesive may undergo a physical
change when compressed against a surface. In other applications, a
pressure-sensitive adhesive may flow into crevices of a surface
when compressed, increasing the bond strength without undergoing a
physical change.
[0042] An attachment device may be used to attach a sealing member
to an attachment surface, such as undamaged epidermis, a gasket, or
another sealing member. The attachment device may take many forms.
For example, an attachment device may be a medically-acceptable,
pressure-sensitive adhesive that extends about a periphery, a
portion, or an entire sealing member. In some embodiments, the
attachment device may be an acrylic-based pressure sensitive
adhesive having a coating weight between about 25 grams/m.sup.2
(gsm) and about 60 gsm. Other example embodiments of an attachment
device may include a double-sided tape, paste, hydrocolloid,
hydrogel, silicone gel, organogel, or an acrylic adhesive.
[0043] A "container" broadly includes a canister, pouch, bottle,
vial, or other fluid collection apparatus. A container, for
example, can be used to manage exudates and other fluids withdrawn
from a tissue site. In many environments, a rigid container may be
preferred or required for collecting, storing, and disposing of
fluids. In other environments, fluids may be properly disposed of
without rigid container storage, and a re-usable container could
reduce waste and costs associated with negative-pressure
therapy.
[0044] A connector 114 may be used to fluidly couple the tube 112
to the sealed therapeutic environment 118. The negative pressure
developed by the negative-pressure source 106 may be delivered
through the tube 112 to the connector 114. In one illustrative
embodiment, the connector 114 may be a T.R.A.C..RTM. Pad or Sensa
T.R.A.C..RTM. Pad available from KCI of San Antonio, Tex. The
connector 114 allows the negative pressure to be delivered to the
sealed therapeutic environment 118. In other exemplary embodiments,
the connector 114 may also be a tube inserted through the drape
108. The negative pressure may also be generated by a device
directly coupled to the drape 108, such as a micropump.
[0045] The provision of negative-pressure therapy with
negative-pressure therapy systems, such as the negative-pressure
therapy system 100, is increasingly being performed with smaller
therapy devices that use battery power rather than a connection to
an electrical outlet. Use of battery power decreases the total
power supply available to a therapy device. As a result, power
drains that would be considered negligible in a device powered
through an electrical outlet connection may significantly reduce
the ability of the therapy device to provide therapy. A power drain
refers to operation of the therapy device that requires use of
electrical power, for example, operation of a pump to generate
negative pressure. Power drains may be caused by low-level dressing
leaks, for example. A low-level dressing leak can drain power from
a battery of a therapy device by repeatedly triggering operation of
the therapy device to maintain the necessary negative pressure at
the tissue site. Power drains can shorten the useful life of the
therapy device by draining the device battery faster, requiring
more frequent disposal of the device, recharging of the battery, or
battery replacement. Leak detection techniques may help to identify
some leaks that may be sealed by the user; however, low-level leaks
will challenge the most sensitive leak detection systems and may
often go undetected.
[0046] Low-level dressing leaks may occur between a drape and
epidermis surrounding a tissue site if the drape fails to
completely seal to the epidermis. Generally, a drape may include an
adhesive having a strength sufficient to seal against leaks but
that may also cause pain to a patient if the drape is removed. A
drape using an acrylic adhesive as described above is generally
suitable for a dressing if a negative-pressure source powered by a
continuous power supply can compensate for a leak.
[0047] Some drapes may use a bonding adhesive an alternative to an
acrylic adhesive. A bonding adhesive may have a bond strength that
is greater than the bond strength of the standard acrylic adhesive.
A bonding adhesive may be better for sealing than a standard
acrylic adhesive, but the bond strength would cause significantly
more discomfort if the drape is removed. In addition, removing a
drape having a bonding adhesive may cause significant damage to
patients having delicate or damaged skin.
[0048] A drape that has a sealing adhesive can fill gaps between
the drape and the epidermis to limit leaks and can be easy to
remove with low discomfort to the patient. Various sealing,
gap-filling adhesives, such as silicone, hydrocolloids, and
hydrogels, have been tried but each has drawbacks. For example,
hydrogel adhesives are usually low tack and prone to swelling,
creep, and mobility when used with fluid systems. Available
hydrogels and hydrocolloids do not adhere well and may move when
anchored. In another example, silicone adhesives can fill gaps and
seal, but are not breathable and may lose the necessary mechanical
bonding strength as the silicone adhesives interact with moisture
during use.
[0049] A hybrid drape having a thick sealing layer that is
perforated and laminated over an adhesive coated film can overcome
many of these challenges. For example, a hybrid drape may include a
film layer having a bonding adhesive applied directly to the film
layer, and a sealing adhesive applied directly to the bonding
adhesive. The sealing adhesive can be perforated to expose the
bonding adhesive. When the drape is applied to a patient, the
bonding adhesive can be pushed through the perforations of the
sealing adhesive to secure the sealing adhesive to the patient.
This laminated configuration may provide the benefits of the
sealing adhesive and the bonding adhesive over the entire drape
area. For example, the laminated configuration can seal typical
low-level leaks and mechanically affix to the epidermis without
secondary processes. The laminated configuration may also require
minimal additional application care by the user and can be
removable with minimal trauma to the patient. However, construction
of the laminated configuration requires additional assembly steps
and an increase in materials that may significantly increase
costs.
[0050] Other hybrid drapes may register a bonding adhesive and a
sealing adhesive. These hybrid drapes apply both the bonding
adhesive and the sealing adhesive directly to a film layer. The
bonding adhesive and the sealing adhesive may each cover different
portions of the film layer to reduce the overall thickness of the
hybrid drape and decrease the amount of adhesive needed to
construct the hybrid drape. However, the complexity of the
manufacturing process may also have increased costs relative to a
non-hybrid drape.
[0051] For some negative-pressure therapies, a standard drape
having a standard acrylic adhesive may be used while treatment
occurs in a care facility, such as a hospital. The
negative-pressure therapy may be performed using a wall-powered
negative-pressure source. Often, a patient may be discharged from a
care facility before negative-pressure therapy concludes.
Negative-pressure therapy may continue outside of the care facility
using a portable negative-pressure source. A hybrid drape may be
applied to address leaking issues that may arise with a portable
negative-pressure source. However, it may be disadvantageous to
change the dressing during the transition. For example, changing
the dressing may increase the cost of negative-pressure therapy by
requiring additional dressings to be used. Changing the dressing
may also cause additional irritation to the tissue site, which may
negatively impact healing of the tissue site and patient
comfort.
[0052] As disclosed herein, the negative-pressure therapy system
100 can overcome these challenges and others by providing the
sealing tape 124 having a hybrid adhesive configuration. In some
embodiments, the sealing tape 124 may have two adhesives, a bonding
adhesive and a sealing adhesive. As shown in FIG. 1A, the sealing
tape 124 may be applied to the drape 108 so that the sealing tape
124 may partially couple to the drape 108 and partially couple to
the epidermis 116, covering an edge of the drape 108. The sealing
tape 124 may provide increased sealing of the drape 108 to the
epidermis 116.
[0053] FIG. 1B is a plan view of the dressing 104 illustrating
additional details that may be associated with some embodiments. As
shown, the tissue interface 110 may be disposed at the tissue site
102 and covered with the drape 108 to form the sealed therapeutic
environment 118. The sealing tape 124 may be positioned to cover
edges of the drape 108. In some embodiments, the sealing tape 124
may be partially coupled to the drape 108 and partially coupled to
the epidermis 116. In some embodiments, ends of the sealing tape
124 may overlap one another.
[0054] FIG. 2A is a sectional view of the negative-pressure therapy
system 100 for treating the tissue site 102 with negative pressure
illustrating details that may be associated another embodiment. In
some embodiments, the sealing tape 124 may be applied directly to
the epidermis 116 adjacent to the tissue site 102. The drape 108
may be coupled directly to the sealing tape 124. The sealing tape
124 may provide a stronger bond to the epidermis 116 and a better
surface for the drape 108 to seal to, decreasing the size of the
leaks through the dressing 104. The drape 108 may bond directly to
a surface of the sealing tape 124 opposite the epidermis 116. The
surface of the sealing tape 124 may be formed of a material to
which the standard adhesive of the drape 108 may bond to more
readily than the epidermis 116. In addition, the surface of the
drapes strips 124 may have fewer crevices, bumps, and cracks than
the epidermis 116, providing a better bonding surface for the drape
108.
[0055] FIG. 2B is a plan view of the dressing 104 illustrating
additional details that may be associated with some embodiments. As
shown, the tissue interface 110 may be disposed at the tissue site
102. The sealing tape 124 may be disposed around the tissue site
102 to form a window 125, the tissue site 102 being within
boundaries of the window 125. In some embodiments, the window 125
may be an area of tissue having peripheral portions bounded by the
sealing tape 124. In some embodiments, four sealing tape 124 may be
disposed on the epidermis 116 so that the window 125 has a square
shape having the tissue site 102 within the window 125. In other
embodiments, more or fewer sealing tape 124 may be used as needed
and may form other shapes. In some embodiments, the sealing tape
124 may couple directly to the epidermis 116. The drape 108 may
then be coupled at least to the sealing tape 124 to cover the
tissue site 102 and the tissue interface 110 to form the sealed
therapeutic environment 118. In some embodiments, ends of the
sealing tape 124 may overlap. In other embodiments, the sealing
tape 124 may be cut so that ends of the sealing tape 124 do not
overlap.
[0056] FIG. 3 is an exploded perspective view of the sealing tape
124, illustrating details that may be associated with some
embodiments. In some embodiments, the sealing tape 124 may include
a film layer 126, a layer of a bonding adhesive 128, and a layer of
a sealing adhesive 130. The film layer 126 may be
liquid-impermeable and vapor-permeable, that is, the film layer 126
may allow vapor to egress and inhibit liquids from exiting. The
film layer 126 may be a flexible film that is breathable and may
have a high moisture vapor transfer rate (MVTR), for example,
greater than or equal to about 300 g/m.sup.2/24 hours. The film
layer 126 may be formed from a range of medically approved films
ranging in thickness typically from about 15 microns (.mu.m) to
about 50 microns (.mu.m). In other embodiments, a drape having a
low MVTR or that allows no vapor transfer might be used. In some
embodiments, the film layer 126 can also function as a barrier to
liquids and microorganisms.
[0057] The film layer 126 may be formed from numerous materials,
such as one or more of the following: hydrophilic polyurethane
(PU), cellulosics, hydrophilic polyamides, polyvinyl alcohol,
polyvinyl pyrrolidone, hydrophilic acrylics, hydrophilic silicone
elastomers, and copolymers of these. In some embodiments, the film
layer 126 may be formed from a breathable cast matt polyurethane
film sold by Expopack Advanced Coatings of Wrexham, United Kingdom,
under the name INSPIRE 2301. The illustrative film may have an MVTR
(inverted cup technique) of 14400 g/m.sup.2/24 hours and may be
approximately 30 microns thick.
[0058] The bonding adhesive 128 may be coupled directly to the film
layer 126. In some embodiments, the bonding adhesive 128 and the
film layer 126 may be coextensive. In other embodiments, the
bonding adhesive 128 and the film layer 126 may not be coextensive.
A bonding adhesive may be a medically-acceptable,
pressure-sensitive adhesive. For example, a bonding adhesive may be
formed from an acrylic adhesive, rubber adhesive, high-tack
silicone adhesive, polyurethane, or other substance. In some
embodiments, a bonding adhesive may be formed from an acrylic
adhesive with a coating weight of about 15 gsm to about 70 gsm. A
bonding adhesive may also be a high-bond strength acrylic adhesive,
patterrubber adhesive, high-tack silicone adhesive, or
polyurethane, for example. In some embodiments, the bond strength
or tackiness of a bonding adhesive may have a peel adhesion or
resistance to being peeled from a stainless steel material between
about 6 Newtons/25 millimeters (N/mm) to about 10N/25 mm on
stainless steel substrate at 23.degree. C. at 50% relative humidity
based on the American Society for Testing and Materials ("ASTM")
standard ASTM D3330.
[0059] The bonding adhesive 128 may be a continuous layer of
material or may be a layer with apertures (not shown). The
apertures may be formed after application of the bonding adhesive
128 or may be formed by coating the bonding adhesive 128 in
patterns on a carrier layer. The apertures may be sized to help
control the resultant tackiness of the bonding adhesive 128. The
apertures may also be sized to enhance the MVTR of the sealing tape
124. The bonding adhesive 128 may couple the film layer 126 to the
sealing adhesive 130.
[0060] The sealing adhesive 130 has a thickness 132 that may be in
the range of about 100 microns (.mu.m) to about 1000 microns
(.mu.m). A sealing adhesive may be a soft material that provides a
good seal with the tissue site 102. A sealing adhesive may be
formed of a silicone gel (or soft silicone), hydrocolloid,
hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrenic
copolymer gels, or foamed gels with compositions as listed, or soft
closed cell foams (polyurethanes, polyolefins) coated with an
adhesive (e.g., 30 gsm-70 gsm acrylic), polyurethane, polyolefin,
or hydrogenated styrenic copolymers. In some embodiments, a sealing
adhesive may have a stiffness between about 5 Shore 00 and about 80
Shore 00. A sealing adhesive may be hydrophobic or hydrophilic. A
sealing adhesive may be an adhesive having a low to medium
tackiness, for example, a silicone polymer, polyurethane, or an
additional acrylic adhesive. In some embodiments, the bond strength
or tackiness of a sealing adhesive may have a peel adhesion or
resistance to being peeled from a stainless steel material between
about 0.5N/25 mm to about 1.5N/25 mm on stainless steel substrate
at 23.degree. C. at 50% relative humidity based on ASTM D3330. A
sealing adhesive may achieve the bond strength above after a
contact time of less than 60 seconds. Tackiness may be considered a
bond strength of an adhesive after a very low contact time between
the adhesive and a substrate. In some embodiments, a sealing
adhesive may have a tackiness that may be about 30% to about 50% of
the tackiness of a bonding adhesive.
[0061] The sealing adhesive 130 may be formed with a plurality of
apertures 134. The apertures 134 may be numerous shapes, for
example, circles, squares, stars, ovals, polygons, slits, complex
curves, rectilinear shapes, triangles, or other shapes. Each
aperture 134 of the plurality of apertures 134 may have an
effective diameter. An effective diameter may be a diameter of a
circular area having the same surface area as the aperture 134. The
average effective diameter of each aperture 134 may be in the range
of about 6 mm to about 50 mm. The apertures 134 may have a uniform
pattern or may be randomly distributed on the sealing adhesive 130.
For example, in some embodiments, the apertures 134 may be
distributed so that the apertures 134 extend to edges of the
sealing tape 124. In other embodiments, the apertures 134 may be
distributed so that a portion of the sealing adhesive 130 includes
no apertures 134.
[0062] FIG. 4A is a sectional view of a portion of the sealing tape
124 illustrating additional details that may be associated with
some embodiments. In the assembled state, the bonding adhesive 128
may be coupled to the film layer 126, and the sealing adhesive 130
may be coupled to the bonding adhesive 128. If the sealing adhesive
130 is placed proximate to or in contact with the epidermis 116,
the sealing adhesive 130 may form sealing couplings 131 with the
epidermis 116. In some embodiments, the thickness 132 of the
sealing adhesive 130 may create a gap 133 between the bonding
adhesive 128 and the epidermis 116.
[0063] FIG. 4B is a sectional view of the sealing tape 124
illustrating additional details that may be associated with some
embodiments. If the sealing tape 124 is in a desired location,
pressure may be applied to the film layer 126. The pressure may
cause the bonding adhesive 128 to be pressed at least partially
into contact with the epidermis 116 to form bonding couplings 136.
The bonding couplings 136 may provide secure, releasable mechanical
fixation to the epidermis 116. The sealing couplings 131 between
the sealing adhesive 130 and the epidermis 116 may be sufficient to
seal the film layer 126 to the epidermis 116. The sealing couplings
131 may not be as mechanically strong as the bonding couplings 136
between the bonding adhesive 128 and the epidermis 116. The bonding
couplings 136 may also anchor the sealing tape 124 to the epidermis
116, inhibiting migration of the sealing tape 124 and the sealing
adhesive 130.
[0064] The average effective diameter of the apertures 134 of the
sealing adhesive 130 may be varied as one control of the tackiness
or adhesion strength of the sealing tape 124. In this regard, there
is interplay between three main variables for each embodiment: the
thickness 132, the average effective diameter of the plurality of
apertures 134, and the tackiness of the bonding adhesive 128. The
more bonding adhesive 128 that extends through the apertures 134,
the stronger the bond of the bonding coupling 136. The smaller the
thickness 132 of the sealing adhesive 130, the more bonding
adhesive 128 generally extends through the apertures 134 and the
greater the bond of the bonding coupling 136. As an example of the
interplay, if a very tacky bonding adhesive 128 is used and the
thickness 132 of the sealing adhesive 130 is small, the average
effective diameter of the plurality of apertures 134 may be
relatively smaller. In some embodiments, the thickness 132 may be
approximately 200 microns, the bonding adhesive 128 may be
approximately 30 microns, have a tackiness of 2000 g/25 cm wide
strip, and the average effective diameter may be about 6 mm.
[0065] FIG. 5 is an exploded perspective view of the sealing tape
124 illustrating additional details that may be associated with
some embodiments. The sealing tape 124 may include the film layer
126 and an adhesive layer 138 adjacent to the film layer 126.
[0066] FIG. 6 is an exploded cross sectional view of the sealing
tape 124 illustrating additional details that may be associated
with some embodiments. The film layer 126 may have a first side 140
and a second side 142. The adhesive layer 138 may be coupled to the
second side 142 of the film layer 126. The adhesive layer 138 may
be a medically-acceptable, pressure-sensitive adhesive, glue,
bonding agent, or cement, for example. In some embodiments, two
adhesives having different characteristics may be used to form the
adhesive layer 138. For example, the adhesive layer 138 may include
a first adhesive such as the bonding adhesive 128 and a second
adhesive such as the sealing adhesive 130. In some embodiments, the
placement of the bonding adhesive 128 and the sealing adhesive 130
may be coordinated so that the bonding adhesive 128 and the sealing
adhesive 130 both couple directly to the second side 142 of the
film layer 126.
[0067] The bonding adhesive 128 may be disposed on the film layer
126 in a pattern and may be about 30 microns to about 60 microns in
thickness. In a non-limiting illustrative example, the bonding
adhesive 128 of the adhesive layer 138 comprises an acrylic
adhesive with coating weight of 15 grams/m.sup.2 (gsm) to 70
grams/m.sup.2 (gsm). In some embodiments, the sealing adhesive 130
may be disposed on the film layer 126 in a pattern and may be about
100 microns to about 400 microns thick. In some embodiments, the
adhesive layer 138 may partially cover the second side 142 of the
film layer 126, leaving portions of the second side 142 of the film
layer 126 free of adhesive. In other embodiments, the adhesive
layer 138 may be coextensive with the second side 142 of the film
layer 126.
[0068] FIG. 7 is a sectional view of the sealing tape 124
illustrating additional details that may be associated with some
embodiments. In some embodiments, the thickness of the bonding
adhesive 128 may be less than the thickness of the sealing adhesive
130 so that the adhesive layer 138 may have a varying thickness. If
the adhesive layer 138 is applied to the epidermis 116, the sealing
adhesive 130 may can form the sealing couplings 131 with the
epidermis 116. In some embodiments, the thickness of the bonding
adhesive 128 may be less than the thickness of the sealing adhesive
130, forming the gap 133 between the bonding adhesive 128 and the
epidermis 116.
[0069] FIG. 8 is a sectional view of the sealing tape 124
illustrating additional details that may be associated with some
embodiments. If the sealing tape 124 is in a desired location,
pressure may be applied to the first side 140 of the film layer
126. The pressure may cause the bonding adhesive 128 to be pressed
at least partially into contact with the epidermis 116 to form the
bonding couplings 136. The bonding couplings 136 can provide
secure, releasable mechanical fixation to the epidermis 116. The
sealing couplings 131 between the sealing adhesive 130 and the
epidermis 116 may be sufficient to seal the film layer 126 to the
epidermis 116. The sealing couplings 131 may not be as mechanically
strong as the bonding couplings 136 between the bonding adhesive
128 and the epidermis 116.
[0070] According to an illustrative embodiment of the drape 108 in
the context of the negative-pressure therapy system 100, the tissue
interface 110 may be disposed proximate to the tissue site 102. In
some embodiments, the drape 108 may be disposed over the tissue
interface 110 and the epidermis 116 to form the sealed therapeutic
environment 118. The sealing tape 124 may be applied to the edge of
the drape 108 so that a width of each sealing tape 124 overlaps an
edge of the drape 108. In some embodiments, each sealing tape 124
may partially cover the drape 108 and partially cover the epidermis
116. The bonding adhesive 128 of the sealing tape 124 may form
bonding couplings 136 with the epidermis 116 and a top surface of
the drape 108, while the sealing adhesive 130 may form sealing
couplings 131 with the epidermis 116 and the top surface of the
drape 108. In some embodiments, the bonding couplings 136 may have
a peel force against the epidermis 116 between about 0.5N/25 mm to
about 2N/25 mm. In this manner, the sealing tape 124 may seal the
edges of the drape 108, decreasing leaks between the drape 108 and
the epidermis 116.
[0071] In another illustrative embodiment, the tissue interface 110
may be disposed proximate to the tissue site 102. One or more
sealing tape 124 may be disposed around the tissue site 102 to form
the window 125 containing the tissue site 102. The sealing adhesive
130 of each sealing tape 124 may form the sealing couplings 131
with the epidermis 116, and the bonding adhesive 128 of each
sealing tape 124 may form the bonding couplings 136 with the
epidermis 116. In some embodiments, the bonding couplings 136 may
have a peel force against the epidermis 116 between about 0.5N/25
mm to about 2N/25 mm. The drape 108 may be disposed over the tissue
interface 110 and the epidermis 116 and coupled to the sealing tape
124 to form the sealed therapeutic environment 118. The bonding
couplings 136 and the sealing couplings 136 of the sealing tape 124
may seal the sealing tape 124 to the epidermis 116. The drape 108
may be coupled to the film layer 126 of the sealing tape 124. The
first surface 140 of the film layer 126 may provide a bonding
surface that is more suitable for adhesion by the standard adhesive
of the drape 108 than the epidermis 116. In this manner, the
sealing tape 124 may decrease instances of leaks between the drape
108 and the epidermis 116.
[0072] As shown in FIG. 6, FIG. 7, and FIG. 8, the pattern of the
bonding adhesive 128 and the pattern of the sealing adhesive 130
may be registered. Registration of the bonding adhesive 128 and the
sealing adhesive 130 generally refers to the alignment of the two
adhesives relative to one another. In particular, registration of
the bonding adhesive 128 and the sealing adhesive 130 may refer to
the coordination of adhesive placement on the film layer 126 to
achieve a desired effect. For example, a certain percentage of
overlap of one adhesive over the other adhesive, minimal overlap of
one adhesive over the other adhesive so that the adhesives are
offset from one another, or complete overlap of one adhesive over
the other adhesive are all adhesive placements that may be
considered registered. For example, the bonding adhesive 128 and
the sealing adhesive 130 may be registered by being disposed on the
second side 142 of the film layer 126 so that the bonding adhesive
128 and the sealing adhesive 130 each substantially couple to the
second side 142 of the film layer 126. In addition, the bonding
adhesive 128 and the sealing adhesive 130 of the example may be
aligned relative to one another to have minimal overlap of one
adhesive over the other adhesive. In another example, the sealing
adhesive 130 may be offset from the bonding adhesive 128, with both
adhesives being coupled to the second side 142 of the film layer
126. Registering the bonding adhesive 128 and the sealing adhesive
130 can provide for easier manufacturing and use of the sealing
tape 124. Registering of the bonding adhesive 128 and the sealing
adhesive 130 may also enhance desired properties of the sealing
tape 124 as described in more detail below. Illustrative, but
non-limiting, examples of the registration of the bonding adhesive
128 and the sealing adhesive 130 may be described in more detail
with respect to the following embodiments.
[0073] FIG. 9 is a plan view of the sealing tape 124 illustrating
additional details that may be associated with some embodiments.
The sealing tape 124 may have a width 160 and a length 162. In some
embodiments, the width 160 may be between about 20 mm. In other
embodiments, the width 160 may be between about 10 mm to about 30
mm. In some embodiments, the length 162 may be up to about 200 mm.
The sealing tape 124 may be cut or torn so that a sealing tape 124
having the length 162 suitable for use may be provided. For
example, a sealing tape 124 may be provided in rolls, allowing a
clinician to select a length suitable for a particular tissue site
and cut or tear an end of the sealing tape 124 to remove it from
the roll. The sealing tape 124 may also include the bonding
adhesive 128 and the sealing adhesive 130 having apertures 134. In
some embodiments, the bonding adhesive 128 may have a coating
weight of about 25 gsm. In some embodiments, the sealing adhesive
130 may have a coating weight of about 100 gsm to about 600 gsm. In
some embodiments, the apertures 134 may have a diameter between
about 7 mm to about 10 mm. In other embodiments, the apertures 134
may have a diameter between about 5 mm to about 30 mm. In some
embodiments, the sealing tape 124 may include two rows of apertures
134 that may be offset from one another. In some embodiments, the
apertures 134 may be evenly distributed on the sealing tape
124.
[0074] FIG. 10 is a plan view of a sealing tape 224 illustrating
additional details that may be associated with some embodiments.
The sealing tape 224 may be similar to and operate in a manner
similar to the sealing tape 124 of FIG. 9. Similar elements have
been indexed to 200. For example, the sealing tape 224 may have a
width 260, a length 262, a layer of a bonding adhesive 228, a layer
of a sealing adhesive 230, and apertures 234. The apertures 234 may
be positioned similar to the apertures 134. In some embodiments,
the sealing adhesive 230 of the sealing tape 224 may include edge
apertures 235. If the apertures 234 are circles, as shown, the edge
apertures 235 may be semi-circles having a radius equal to a radius
of the apertures 234. The edge apertures 235 may be positioned so
that a diameter of each edge aperture 235 is adjacent to an edge of
the sealing tape 224 that is parallel to the length 262. In some
embodiments, the edge apertures 235 may be disposed along both
edges. In other embodiments, the edge apertures 235 may only be
disposed along one edge. The apertures 234 and the edge apertures
235 may be evenly distributed on the sealing tape 224. For example,
each aperture 234 and edge aperture 235 may be separated from
adjacent apertures 234 and edge apertures 235 by a same distance.
In some embodiments, an even distribution may produce a sealing
tape 224 having apertures 234 and apertures 235 extending between
edges of the sealing tape 224 at regularly repeating distances. The
apertures 235 may expose a portion of the bonding adhesive 228 at
the edges of the sealing tape 224. Exposure of the bonding adhesive
228 proximate to the edge of the sealing tape 224 may aid in
resistance to edge lifting during use of the sealing tape 224. Edge
lifting may be the lifting of a portion of the sealing tape 224
when the edge of the sealing tape 224 is caught by clothing or
other objects.
[0075] FIG. 11 is a plan view of a sealing tape 324 illustrating
additional details that may be associated with some embodiments.
The sealing tape 324 may be similar to and operate in a manner
similar to the sealing tape 124 of FIG. 9. Similar elements have
been indexed to 300. For example, the sealing tape 324 may have a
width 360, a length 362, a layer of a bonding adhesive 328, a layer
of a sealing adhesive 330, and apertures 334. In some embodiments,
the apertures 134 may have a diameter between about 10 mm and about
15 mm. In other embodiments, the apertures 334 may have a diameter
between about 5 mm and about 30 mm. In some embodiments, the
sealing tape 324 may include a single row of apertures 334. In some
embodiments, the apertures are disposed near a center of the width
360 of the sealing tape 334 and may be evenly distributed parallel
to the length 362 of the sealing tape 334.
[0076] FIG. 12 is a plan view of a sealing tape 424 illustrating
additional details that may be associated with some embodiments.
The sealing tape 424 may be similar to and operate in a manner
similar to the sealing tape 224 of FIG. 10. Similar elements have
been indexed to 400. For example, the sealing tape 424 may have a
width 460, a length 462, a layer of a bonding adhesive 428, a layer
of a sealing adhesive 430, and apertures 435. The apertures 435 may
be positioned similar to the apertures 235 and have a radius equal
to a radius of the apertures 334.
[0077] FIG. 13 is a plan view of a sealing tape 524 illustrating
additional details that may be associated with some embodiments.
The sealing tape 524 may be similar to and operate in a manner
similar to the sealing tape 124 of FIG. 9. Similar elements have
been indexed to 500. For example, the sealing tape 524 may have a
width 560, a length 562, a strip of a bonding adhesive 528, and a
strip of a sealing adhesive 530. In some embodiments, the sealing
tape 524 may include two strips of the sealing adhesive 530
disposed adjacent to an edge of the sealing tape 524. The two
strips of the sealing adhesive 530 may be parallel to the length
562. In some embodiments, the two strips of the sealing adhesive
530 may each have a width 564. In some embodiments, the width 564
of each strip of the sealing adhesive 530 may be between about 5 mm
and about 7 mm. In some embodiments, a width 566 of the bonding
adhesive 528 exposed through the sealing adhesive 530 may be
between about 6 mm and about 10 mm.
[0078] FIG. 14 is a plan view of a sealing tape 624 illustrating
additional details that may be associated with some embodiments.
The sealing tape 624 may be similar to and operate in a manner
similar to the sealing tape 524 of FIG. 13. Similar elements have
been indexed to 600. For example, the sealing tape 624 may have a
width 660, a length 662, one or more strips of a bonding adhesive
628, and one or more strips of a sealing adhesive 630. In some
embodiments, the sealing tape 624 may include two strips of the
sealing adhesive 630. In some embodiments, a first strip 631 of the
sealing adhesive 630 may be disposed adjacent to an edge of the
sealing tape 624. A second strip 633 of the sealing adhesive 630
may be disposed between the edges of the sealing tape 624. The
first strip 631 and the second strip 633 of the sealing adhesive
630 may be parallel to the length 662. In some embodiments, the
first strip 631 and the second strip 633 of the sealing adhesive
630 may each have a width 664. In some embodiments, the width 664
may be between about 5 mm and about 7 mm. In some embodiments, the
portion of the bonding adhesive 628 exposed through the sealing
adhesive 630 may include a first strip 627 and a second strip 629.
The first strip 627 may be disposed between the first strip 631 and
the second strip 633 of the sealing adhesive 630. The second strip
629 may be disposed adjacent to an edge of the sealing tape 624
opposite the first strip 631. In some embodiments, a width 666 of
each of the first strip 627 and the second strip 629 of the bonding
adhesive 628 exposed through the sealing adhesive 630 may be
between about 3 mm and about 5 mm. In some embodiments, the sealing
tape 624 may be applied so that the second strip 629 of the bonding
adhesive 628 may be in contact with the epidermis 116 to form
bonding couplings 136 with the epidermis. The first strip 627 of
the bonding adhesive 628 may be in contact with the drape 108 to
form bonding couplings 136 with the drape 108.
[0079] FIG. 15 is a plan view of a sealing tape 724 illustrating
additional details that may be associated with some embodiments.
The sealing tape 724 may be similar to and operate in a manner
similar to the sealing tape 124 of FIG. 9. Similar elements have
been indexed to 700. For example, the sealing tape 724 may have a
width 760, a length 762, a bonding adhesive 728, and a sealing
adhesive 730. In some embodiments, the sealing adhesive 730 may
trace a path between opposite edges of the sealing tape 724. The
sealing adhesive 730 may propagate parallel to the length 762. For
example, the sealing adhesive 730 may have a pattern similar to a
wave. In some embodiments, the sealing adhesive 730 may have a
regular wave pattern with a repeating slope between each edge of
the sealing tape 724. In some embodiments, the sealing adhesive 730
may have a width 768. In some embodiments, the width 768 may be
between about 5 mm and about 7 mm.
[0080] Any of the above patterns may be manufacturing by layering
the adhesives as described above with respect to FIG. 3, FIG. 4A,
and FIG. 4B or by registering the adhesives as described above with
respect to FIG. 5, FIG. 6, FIG. 7, and FIG. 8.
[0081] In some embodiments, the adhesives may be mixed with blowing
or expanding agents, for example organic and inorganic low
temperature boiling point liquids. The blowing or expanding agents
allow for the adhesives to expand under the application of heat or
light to increase the thickness of the adhesive following
deposition by one of the above described processes. The blowing or
expanding agents may reduce the amount of adhesive needed and
decrease the cost of production and the cost of the resulting
sealing tape 124. In some embodiments, the application of heat or
light may be delayed until application of the sealing tape 124 to
the epidermis 116 so that the contact area with the patient's
epidermis 116 may increase as the bonding adhesive 128 and the
sealing adhesive 130 warm by contact with the patient's epidermis
116. The application of light or heat following application of the
sealing tape 124 to the epidermis 116 can provide a better seal for
some embodiments of the sealing tape 124 to the epidermis 116.
[0082] In testing performed with sealing tape in accordance with
the embodiments described herein, leaks between a standard drape
and a textured surface were reduced. A drape was disposed over the
textured surface to create a sealed space. The drape was fluidly
coupled to a negative-pressure source. The negative-pressure source
was operated and a pressure was measured in the sealed space. When
the pressure was measured, the negative-pressure source was unable
to achieve 125 mm Hg negative pressure. A leak of about 2 L/m was
determined to exist between the standard drape and the textured
surface.
[0083] Sealing tape in accordance with the embodiments described
herein were applied to the edges of the drape. The
negative-pressure source was again operated and the pressure
measured in the sealed space. By using the sealing tape, the
negative-pressure source was able to achieve the therapy pressure
of 125 mm Hg and the leak was reduced to 0.08 L/m. The textured
surface was then heated, further reducing the leak to 0.01 L/m.
[0084] Sealing tape in accordance with the embodiments described
herein were also disposed directly on the texture surface. The
standard drape was disposed over the textured surface and coupled
to the sealing tape to create the sealed space. The textured
surface was heated to mimic a patient's body heat. The standard
drape was fluidly coupled to the negative-pressure source. The
negative-pressure source was operated and a pressure was measured
in the sealed space. The negative-pressure source was able to
achieve 125 mm Hg negative pressure and the leak was reduced to
0.003 L/m.
[0085] The sealing tape may provide a lower cost solution to
improving the sealing of standard drapes. The sealing tape may be
added to current dressings with low disruption to production or
use. The sealing tape also provide a step-change improvement in
sealing with a pre-applied dressing using existing materials prior
to release from a facility. The sealing tape may also later be used
under a drape on re-application of the dressing to provide a seal
to a tissue site. The sealing tape may also provide an increased
efficiency of adhesive usage as less silicone adhesive may be
needed to retain the silicone adhesive in place and under
compression with the acrylic adhesive.
[0086] Although illustrative, non-limiting embodiments have been
disclosed, it should be understood that various changes,
substitutions, permutations, and alterations can be made without
departing from the scope of the appended claims. It will be
appreciated that features that may be described in connection to
one embodiment may also be applicable to other embodiments. It will
also be understood that the benefits and advantages described above
may relate to one embodiment or may relate to several embodiments.
It will further be understood that reference to "an" item refers to
one or more of those items.
[0087] The steps of the methods described herein may be carried out
in a suitable order, or simultaneously where appropriate.
[0088] Where appropriate, aspects of the embodiments described
above may be combined with aspects of the other embodiments
described to form further examples having comparable or different
properties and addressing the same or different problems.
[0089] It will be understood that the embodiments described herein
are given by way of example only and that various modifications may
be made by those skilled in the art. The above specification,
examples and data provide a complete description of the structure
and use of exemplary embodiments. Although various embodiments have
been described above with a certain degree of particularity, or
with reference to one or more individual illustrations, those
skilled in the art could make numerous alterations to the example
embodiments without departing from the scope of the claims.
* * * * *