U.S. patent application number 17/233156 was filed with the patent office on 2021-08-19 for moisture absorbing seal.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Timothy Mark ROBINSON.
Application Number | 20210251811 17/233156 |
Document ID | / |
Family ID | 1000005553425 |
Filed Date | 2021-08-19 |
United States Patent
Application |
20210251811 |
Kind Code |
A1 |
ROBINSON; Timothy Mark ; et
al. |
August 19, 2021 |
MOISTURE ABSORBING SEAL
Abstract
A sealing drape may be suitable for use with a reduced-pressure
treatment system for treating a tissue site. The sealing drape may
have an interior surface adapted for positioning adjacent to a
peripheral surface of the tissue site. The sealing drape may
include a sealing material and an absorbent material. The sealing
material may be hydrophobic and substantially free of hydrophilic
components. Further, the sealing material may be positioned between
the interior surface of the sealing drape and the absorbent
material. The sealing drape may be used with a manifold for
positioning at the tissue site, a reduced-pressure interface, and a
reduced-pressure source. Methods of manufacture and treatment are
also disclosed.
Inventors: |
ROBINSON; Timothy Mark;
(Shillingstone, GB) ; LOCKE; Christopher Brian;
(Bournemouth, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
1000005553425 |
Appl. No.: |
17/233156 |
Filed: |
April 16, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15788013 |
Oct 19, 2017 |
11007084 |
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17233156 |
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14104630 |
Dec 12, 2013 |
9833363 |
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15788013 |
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61748711 |
Jan 3, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 13/0223 20130101;
A61F 13/00068 20130101; A61F 13/0216 20130101; A61F 13/022
20130101; Y10T 156/10 20150115; A61M 1/90 20210501 |
International
Class: |
A61F 13/02 20060101
A61F013/02; A61F 13/00 20060101 A61F013/00; A61M 1/00 20060101
A61M001/00 |
Claims
1. A sealing drape for treating a tissue site, the sealing drape
comprising: an interior surface and an external surface, the
interior surface adapted to be positioned adjacent a peripheral
surface surrounding the tissue site and to overlap the peripheral
surface to provide a sealed space between the sealing drape and the
tissue site; a sealing material comprising a fluid permeable
hydrophobic material substantially free of hydrophilic components,
the sealing material comprising a first layer and second layer,
wherein at least a portion of the sealing material forms a part of
the interior surface of the sealing drape; and an absorbent
material adapted to absorb fluid communicated through the sealing
material, the absorbent material comprising a sheet-like absorbent
layer disposed between the first layer and the second layer of the
sealing material.
2. The sealing drape of claim 1, wherein the absorbent material
comprises a plurality of sheet-like absorbent layers disposed
between the first layer and the second layer of the sealing
material.
3. The sealing drape of claim 1, wherein the absorbent material is
configured to provide an absorptive gradient through the sealing
drape.
4. The sealing drape of claim 1, further comprising a carrier that
carries the absorbent material, the carrier and the absorbent
material being disposed between the first layer and the second
layer of the sealing material.
5. The sealing drape of claim 4, wherein the carrier comprises a
hydrophobic polypropylene sheet.
6. The sealing drape of claim 1, further comprising a plurality of
absorbent materials disposed in the sealing material of the sealing
drape, the absorbent materials having an absorptive capacity that
increases with increasing distance through a cross section of the
sealing drape from the interior surface of the sealing drape.
7. The sealing drape of claim 1, wherein the absorbent material
comprises a three-dimensional structure of interconnected absorbent
fibers, absorbent particles, and sheet-like absorbent layers.
8. The sealing drape of claim 1, wherein: the sealing material
consists of a hydrophobic silicone elastomer; and the absorbent
material is selected from a group consisting of carboxymethyl
cellulose, a salt of carboxymethyl cellulose, a cross-linked
hydrophilic acrylic, a cross-linked hydrophilic acrylic salt, and
an acrylamide.
9. The sealing drape of claim 1, wherein the sealing material
comprises a hydrophobic elastomer.
10. The sealing drape of claim 9, wherein the hydrophobic elastomer
is silicone.
11. The sealing drape of claim 1, further comprising an attachment
device configured to adhere the interior surface of the sealing
drape to a peripheral surface of the tissue site to provide a
sealed space between the sealing drape and the tissue site.
12. The sealing drape of claim 11, wherein the attachment device
comprises a silicone adhesive, a hot-melt adhesive, a hydrogel, a
hydrocolloid, a pressure-sensitive adhesive, a double-sided drape
tape, or a paste.
13. The sealing drape of claim 1, wherein the sealing material of
the sealing drape is adapted to provide evaporation of fluid
retained in the absorbent material through the external surface of
the sealing drape.
14. A method of manufacturing a sealing drape for treating a tissue
site, the method comprising: providing a first layer and a second
layer of a sealing material consisting of a hydrophobic elastomer,
the sealing material having a first surface and a second surface;
providing an absorbent material as an absorbent layer; positioning
the absorbent layer as a sheet between the first layer and the
second layer of the sealing material; providing an attachment
device; and disposing the attachment device on the first surface of
the sealing material.
15. The method of claim 14, wherein the step of positioning the
absorbent layer between the first layer of the sealing material and
the second layer of the sealing material comprises: providing a
carrier; carrying the absorbent material with the carrier; and
positioning the carrier and the absorbent material between the
first layer of the sealing material and the second layer of the
sealing material.
16. The method of claim 15, wherein the carrier comprises a
hydrophobic polypropylene sheet.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/788,013, entitled "Moisture Absorbing
Seal", filed Oct. 19, 2017, which is a divisional of U.S. patent
application Ser. No. 14/104,630, entitled "Moisture Absorbing
Seal", filed Dec. 12, 2013, now U.S. Pat. No. 9,833,363, which
claims the benefit, under 35 USC .sctn. 119(e), of the filing of
U.S. Provisional Patent Application No. 61/748,711, entitled
"Moisture Absorbing Seal," filed Jan. 3, 2013, all of which are
incorporated herein by reference for all purposes.
TECHNICAL FIELD
[0002] The following subject matter relates generally to tissue
treatment systems and, more particularly, but not by way of
limitation, to medical sealing drapes and systems including medical
sealing drapes.
BACKGROUND
[0003] Known tissue treatment systems may use a sealing drape to
provide a fluid seal about a tissue site requiring treatment.
Sealing around particular anatomical areas of the tissue site can
be complicated and a leak-free seal is often difficult to achieve
and maintain. Typical sealing drape materials may lack a
sufficiently conformable adhesive capable of flowing into creases
and cracks around the tissue site to achieve a good seal. Current
materials may also suffer from being unable to transfer moisture
away from the tissue site. Thus, if the sealing drape remains in
place for an extended period of time, moisture present near the
tissue site can cause maceration of the tissue and the formation of
leaks between the tissue site and the sealing drape. Accordingly,
improvements to sealing and moisture transfer capabilities for
sealing drapes are desirable.
SUMMARY
[0004] Shortcomings with certain aspects of known tissue treatment
systems and methods utilizing sealing drapes are addressed as shown
and described in a variety of illustrative, non-limiting
embodiments herein. Other features and advantages of the
illustrative embodiments will become apparent with reference to the
drawings and detailed description that follow.
[0005] In some embodiments, a reduced-pressure system for treating
a tissue site may include a manifold, a sealing drape, and a
reduced-pressure interface. The manifold may be adapted to be
positioned adjacent the tissue site and to distribute reduced
pressure to the tissue site. The sealing drape may have an interior
surface and an external surface. The interior surface of the
sealing drape may be adapted to cover the manifold and the tissue
site to provide a sealed space between the interior surface of the
sealing drape and the tissue site. Additionally, the sealing drape
may include a sealing material and an absorbent material. The
sealing material may be hydrophobic and substantially free of
hydrophilic components. The absorbent material may be associated
with the sealing material such that the sealing material may be
positioned between the interior surface of the sealing drape and
the absorbent material. The reduced-pressure interface may be
adapted to deliver reduced-pressure. The reduced-pressure interface
may be in fluid communication with the sealed space and the
manifold.
[0006] In some embodiments, a sealing drape for treating a tissue
site may include an interior surface, an external surface, a
sealing material, and an absorbent material. The interior surface
may be adapted to be positioned adjacent a peripheral surface
surrounding the tissue site and to overlap the peripheral surface
to provide a sealed space between the sealing drape and the tissue
site. The sealing material may include a fluid permeable,
hydrophobic material substantially free of hydrophilic components.
The absorbent material may be disposed in the sealing material such
that the sealing material may be positioned between the interior
surface of the sealing drape and the absorbent material. The
absorbent material may be adapted to absorb fluid communicated
through the sealing material.
[0007] In some embodiments, a method of manufacturing a sealing
drape for treating a tissue site may include the steps of:
providing a sealing material; providing an absorbent material; and
disposing the absorbent material in the sealing material. The
sealing material may be hydrophobic and substantially free of
hydrophilic components.
[0008] In some embodiments, a reduced-pressure system for treating
a tissue site may include a manifold, a sealing drape, and a
reduced-pressure interface. The manifold may be adapted to be
positioned adjacent the tissue site and to distribute reduced
pressure to the tissue site. The sealing drape may have an interior
surface and an external surface. The interior surface of the
sealing drape may be adapted to be positioned adjacent a peripheral
surface surrounding the tissue site and to cover the manifold and
the tissue site to provide a sealed space between the interior
surface and the tissue site. Further, the sealing drape may be
adapted to extend beyond the tissue site and to overlap the
peripheral surface. Additionally, the sealing drape may include a
sealing material and an absorbent material. The sealing material
may be hydrophobic and substantially free of hydrophilic
components. The absorbent material may be associated with the
sealing material such that the sealing material may be positioned
between the interior surface of the sealing drape and the absorbent
material. The reduced-pressure interface may be adapted to deliver
reduced-pressure. The reduced-pressure interface may be in fluid
communication with the sealed space and the manifold.
[0009] In some embodiments, a method for treating a tissue site may
include the steps of positioning a sealing drape adjacent a
peripheral surface surrounding the tissue site, the sealing drape
extending beyond the tissue site and overlapping the peripheral
surface; and transferring moisture away from the peripheral surface
through the sealing drape.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] A more complete understanding of this specification may be
obtained by reference to the following detailed description when
taken in conjunction with the accompanying drawings wherein:
[0011] FIG. 1 is a side view, with a portion shown in cross
section, of an illustrative embodiment of a reduced-pressure
treatment system depicting an illustrative embodiment of a sealing
drape;
[0012] FIG. 2 is a perspective view of another illustrative
embodiment of a sealing drape suitable for use with the
reduced-pressure treatment system of FIG. 1;
[0013] FIG. 3 is a perspective view of another illustrative
embodiment of a sealing drape suitable for use with the
reduced-pressure treatment system of FIG. 1;
[0014] FIG. 4 is a perspective, exploded view of another
illustrative embodiment of a sealing drape suitable for use with
the reduced-pressure treatment system of FIG. 1;
[0015] FIG. 5 is a perspective, exploded view of another
illustrative embodiment of a sealing drape suitable for use with
the reduced-pressure treatment system of FIG. 1; and
[0016] FIG. 6 is a perspective, exploded view of another
illustrative embodiment of a sealing drape suitable for use with
the reduced-pressure treatment system of FIG. 1.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0017] In the following detailed description of the illustrative,
non-limiting embodiments, reference is made to the accompanying
drawings that form a part hereof. Other embodiments may be
utilized, and logical, structural, mechanical, electrical, and
chemical changes may be made without departing from the scope of
this specification. To avoid detail not necessary to enable those
skilled in the art to practice the embodiments described herein,
the detailed description may omit certain information known to
those skilled in the art. The following detailed description is
provided without limitation, and with the scope of the illustrative
embodiments being defined by the appended claims.
[0018] Referring generally to the drawings, this specification
provides a reduced-pressure treatment system 100 utilizing a
sealing drape 101 for treating a tissue site 102. The
reduced-pressure treatment system 100 is presented in the context
of a tissue site 102 that may include, without limitation, a wound
104 extending through the epidermis 106, the dermis 108, and
reaching into a hypodermis, or subcutaneous tissue 110. The
reduced-pressure treatment system 100 may include a
reduced-pressure dressing 112, a reduced-pressure source 114, and a
reduced-pressure delivery conduit 116. The reduced-pressure
delivery conduit 116 may provide reduced pressure from the
reduced-pressure source 114 to the reduced-pressure dressing 112.
As will be described below, the sealing drape 101 may be a
component of the reduced-pressure dressing 112 that will provide a
fluid seal with the tissue site 102 while preventing the surface of
the tissue site 102 from becoming saturated with moisture.
[0019] The term "tissue site" in this context, for example, may
refer to a wound or defect located on or within any 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,
without limitation, any irregularity with a tissue, such as an open
wound, surgical incision, or diseased tissue. For example, the
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. The
term "tissue site" may also refer to areas of any tissue that are
not necessarily wounded or defective, but are instead areas in
which it is desired to add or promote the growth of additional
tissue. For example, reduced pressure may be used in certain tissue
areas to grow additional tissue that may be harvested and
transplanted to another location.
[0020] In general, components of the reduced-pressure treatment
system 100 may be coupled directly or indirectly. For example, the
reduced-pressure source 114 may be directly coupled to the
reduced-pressure dressing 112 or indirectly coupled to the
reduced-pressure dressing 112 through the reduced-pressure delivery
conduit 116. Components may be fluidly coupled to each other to
provide a path for transferring fluids, such as liquid or gas,
between the components. In some embodiments, components may be
fluidly coupled with a tube. A "tube," as used herein, may refer to
any tube, pipe, hose, conduit, or other structure with one or more
lumina adapted to convey fluids between two ends. In some
embodiments, components may 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.
[0021] "Reduced pressure" may refer to a pressure less than the
ambient pressure at a tissue site being subjected to treatment. The
reduced pressure may be less than the atmospheric pressure. The
reduced pressure may also be less than a hydrostatic pressure at a
tissue site. Unless otherwise indicated, values of pressure stated
herein are gauge pressures. Consistent with the use herein, an
increase in reduced pressure or vacuum pressure may refer to a
relative reduction in absolute pressure.
[0022] The reduced-pressure source 114 may provide reduced pressure
as a part of the reduced-pressure treatment system 100. The
reduced-pressure source 114 may be any device for supplying a
reduced pressure, such as a vacuum pump, wall suction, micro-pump,
or other source. While the amount and nature of reduced pressure
applied to a tissue site may vary according to the treatment
application, the reduced pressure may be between about -5 mm Hg
(-667 Pa) to about -500 mm Hg (-66.7 kPa). In some embodiments, the
reduced pressure may be between about -75 mm Hg (-9.9 kPa) to about
-300 mm Hg (-39.9 kPa).
[0023] As shown in FIG. 1, in some embodiments, the
reduced-pressure dressing 112 may include a manifold 118, the
sealing drape 101, and a reduced-pressure interface 122. The
manifold 118 may have a first side 119 and a second side 121. The
first side 119 of the manifold 118 may be placed within, over,
proximate, adjacent, or in direct contact with the tissue site
102.
[0024] The manifold 118 maybe a substance or structure capable of
applying reduced pressure to, delivering fluids to, or removing
fluids from the tissue site 102. The manifold 118 may be positioned
between the sealing drape 101 and the tissue site 102. The manifold
118 may be partially or fully in contact with the tissue site 102.
The manifold 118 may partially or completely fill the tissue site
102, or the manifold 118 may be placed over the tissue site 102.
The manifold 118 may take many forms, and may be any size, shape,
or thickness depending on a variety of factors, such as the type of
treatment being implemented or the nature and size of a particular
tissue site. For example, the size and shape of the manifold 118
may be adapted to the contours of deep and irregular shaped tissue
sites.
[0025] The manifold 118 may include a plurality of flow channels or
pathways configured to distribute fluids to and remove fluids from
the tissue site 102. In some embodiments, the flow channels or
pathways may be interconnected to improve distribution of fluids
provided to or removed from the tissue site 102. The manifold 118
may be a biocompatible material that is capable of being placed in
contact with the tissue site 102 and distributing reduced pressure
to the tissue site 102. For example, the manifold 118 may include,
without limitation, devices that have structural elements arranged
to form flow channels, such as cellular foam, open-cell foam,
porous tissue collections, liquids, gels, and foams that include,
or cure to include, flow channels. Additionally, the manifold 118
may be a gauze, felted mat, or any other material suited to a
particular biological application.
[0026] In some embodiments, the manifold 118 may be a porous foam
having interconnected cells or pores that act as flow channels. The
porous foam may be, for example, a hydrophobic material, such as a
polyurethane, open-cell reticulated foam manufactured under the
trade name GranuFoam.RTM. by Kinetic Concepts, Inc. of San Antonio,
Tex. In some embodiments, the manifold 118 may also be used to
distribute fluids such as medications, antibacterials, growth
factors, and various solutions to the tissue site 102. Other layers
may be included in or on the manifold 118, such as absorptive
materials, wicking materials, hydrophobic materials, and
hydrophilic materials.
[0027] In some embodiments, the manifold 118 may be made from a
hydrophilic material capable of wicking fluid away from the tissue
site 102 while continuing to distribute reduced pressure to the
tissue site 102. The wicking properties of the manifold 118 may
draw fluid away from the tissue site 102 by capillary flow or other
wicking mechanisms. An example of a hydrophilic foam may be 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 may
include hydrophobic foams that have been treated or coated to
provide hydrophilicity.
[0028] The manifold 118 may promote granulation at a tissue site
when reduced-pressure is present within the reduced-pressure
dressing 112. For example, any or all of the surfaces of the
manifold 118 may have an uneven, coarse, or jagged profile that
induce microstrains and stresses at the tissue site 102 when
reduced pressure is applied through the manifold 118.
[0029] In some embodiments, the manifold 118 may be constructed
from a bioresorbable material that may remain in a patient's body
following use of the reduced-pressure dressing 112. 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 manifold 118
may further serve as a scaffold for new cell-growth, or a scaffold
material may be used in conjunction with the manifold 118 to
promote cell-growth. A scaffold may be 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 may include calcium phosphate, collagen, PLA/PGA, coral
hydroxy apatites, carbonates, or processed allograft materials.
[0030] The sealing drape 101 may be adapted to cover the second
side 121 of the manifold 118 and to seal to a peripheral surface
128 proximate the tissue site 102. Thus, the sealing drape 101 may
provide a fluid seal between the reduced-pressure dressing 112 and
the tissue site 102. "Fluid seal," or "seal," may refer to a seal
adequate to maintain reduced pressure at a desired tissue site
given the particular reduced-pressure source involved.
[0031] The peripheral surface 128 may be undamaged epidermis 106
peripheral to the tissue site 102. Thus, the sealing drape 101 may
provide a sealed space 123 proximate to the tissue site 102 that is
substantially isolated from the external environment, and capable
of maintaining a reduced pressure provided by the reduced-pressure
source 114. Reduced pressure applied through the manifold 118 in
the sealed space 123 can promote healing by inducing macrostrain
and microstrain in the tissue site 102, as well as by removing
exudates and other fluids from the tissue site 102. Fluids from the
tissue site 102 may be collected for disposal by a fluid canister
(not shown) associated with the reduced-pressure source 114.
[0032] The sealing drape 101 may comprise an elastomeric material.
"Elastomeric" may refer to the properties of an elastomer, such as
a polymeric material that has rubber-like properties. More
specifically, some elastomers have elongation rates greater than
100% and a significant amount of resilience. The resilience of a
material may refer to the ability of the material to recover from
an elastic deformation.
[0033] In some embodiments, the reduced-pressure dressing 112 may
also include additional layers (not shown) positioned between the
tissue site 102 and the sealing drape 101. For example, the
reduced-pressure dressing 112 may further include an absorption
layer, tissue-interface layer, or additional manifold layers. The
reduced-pressure dressing 112 may also include an attachment device
(not shown) capable of adhering or otherwise sealing the sealing
drape 101 to the peripheral surface 128. Materials suitable for use
as attachment devices for adhering the sealing drape 101 about a
tissue site, may include, for example, silicones and hot-melt
adhesives. Other attachment devices may include, for example,
hydrogels and hydrocolloids.
[0034] Reduced pressure may be applied to the reduced-pressure
dressing 112 through the reduced-pressure interface 122. The
reduced-pressure interface 122 may be fluidly coupled to the
sealing drape 101 through an aperture 124 in the sealing drape 101.
In the illustrative example of FIG. 1, the aperture 124 is shown
centrally located on the sealing drape 101. However, the aperture
124 may be located anywhere on the sealing drape 101, including
without limitation, a peripheral portion of the sealing drape 101
that may be adjacent to an edge of the sealing drape 101. Although
the aperture 124 is shown to be circular, the aperture 124 may have
any shape. The shape of the aperture 124 may also be adapted to
contour or substantially coordinate with the shape of the
reduced-pressure delivery conduit 116. The reduced-pressure
interface 122 may provide fluid communication between the sealed
space 123 and the reduced-pressure delivery conduit 116 through the
aperture 124.
[0035] The reduced pressure provided by the reduced-pressure source
114 may be delivered through the reduced-pressure delivery conduit
116 to the reduced-pressure interface 122. Thus, the
reduced-pressure source 114 may be fluidly coupled to the
reduced-pressure interface 122 by the reduced-pressure delivery
conduit 116. In some embodiments, the reduced-pressure interface
122 may be a T.R.A.C..RTM. Pad or Sensa T.R.A.C..RTM. Pad available
from Kinetic Concepts, Inc. of San Antonio, Tex. The
reduced-pressure interface 122 may allow the reduced pressure to be
delivered to the sealing drape 101 and realized within the sealed
space 123 formed between the sealing drape 101 and the tissue site
102. In some embodiments, the reduced-pressure interface 122 may
extend through the sealing drape 101 to the manifold 118, but
numerous arrangements are possible. The reduced-pressure interface
122 may deliver the reduced pressure through the aperture 124 of
the sealing drape 101 to the manifold 118 and the tissue site
102.
[0036] Upon application of the reduced pressure to the
reduced-pressure dressing 112, fluids such as exudates from the
tissue site 102 may be drawn into the manifold 118. Some amount of
fluid as a consequence may also be brought into contact with the
sealing drape 101, including portions of the sealing drape 101 that
may be adjacent the peripheral surface 128 surrounding the tissue
site 102. Moisture at the interface between the peripheral surface
128 and the sealing drape 101 may adversely affect the seal between
the sealing drape 101 and the peripheral surface 128, and may
increase the risk of maceration. "Maceration" or "macerating" may
refer to the softening or breaking down of tissue as a result of
prolonged exposure to moisture.
[0037] The sealing drape 101 of the reduced-pressure treatment
system 100 can overcome these shortcomings and others by
maintaining a fluid seal with the tissue site 102, while also
preventing the peripheral surface 128 from becoming saturated with
moisture. The sealing drape 101 may adhere to the tissue site 102
when wet or dry, may transmit and manage low levels of skin
moisture to avoid maceration, and may be left in place for extended
time periods.
[0038] Continuing with the embodiment of FIG. 1, the sealing drape
101 may have an external surface 130 and an interior surface 132.
The interior surface 132 may be adapted to face the tissue site
102. As previously described, the sealing drape 101 may be adapted
to sealingly engage the peripheral surface 128 to provide a sealed
space 123 with the tissue site 102. The interior surface 132 of the
sealing drape 101 may contact the peripheral surface 128
surrounding the tissue site 102 to provide the sealed space 123.
The sealing drape 101 may also be stretchable or elastic in nature.
The stretchable properties of the sealing drape 101 may facilitate
placement of the sealing drape 101 proximate to tissue sites having
a variety of shapes, topologies, or flexibility requirements. The
sealing drape 101 may be sized to extend beyond the tissue site 102
to overlap the peripheral surface 128 surrounding the tissue site
102.
[0039] The sealing drape 101 may include a sealing material 134 and
an absorbent material 136. The sealing material 134 may be fluid
permeable, may provide a substantially sheet-like structure for the
sealing drape 101, and may form a part of the interior surface 132
of the sealing drape 101. The absorbent material 136 may, for
example, be contained within the sealing material 134, dispersed
throughout the sealing material 134, or embedded as a sheet-like
layer within the sealing material 134. The absorbent material 136
may be adapted to absorb moisture, such as exudate, from the tissue
site 102 by drawing or wicking the fluid from the peripheral
surface 128 of the tissue site 102.
[0040] The sealing material 134 may be comprised of any
substantially pure hydrophobic material, and may have a variety of
structures, including materials and structures that allow fluid,
such as liquid or gas, to pass through the sealing material 134
without being absorbed by the sealing material 134. Herein, a
substantially pure hydrophobic material may be substantially free
of hydrophilic components due to the tendency for hydrophilic
materials to retain fluid. For example, the substantially pure
hydrophobic material of the sealing material 134 may not be a
copolymer incorporating a hydrophilic component, such as a
hydrophilic monomer. The sealing material 134, for example, may
comprise a hydrophobic elastomer, such as a hydrophobic silicone
elastomer. The hydrophobic characteristics of the sealing material
134 may prevent the sealing material 134 from directly absorbing
fluid, such as exudate, from the tissue site 102, but may allow the
fluid to pass through. Thus, the sealing material 134 may permit
the passage of fluid away from the peripheral surface 128 and the
tissue site 102 to substantially preclude any adverse affect on the
seal being maintained with the tissue site 102. In this manner, the
sealing material 134 may enhance the management of fluid in the
reduced-pressure dressing 112 to allow for a continued fluid seal
with the tissue site 102, while also protecting the tissue site 102
and surrounding areas from maceration.
[0041] The absorbent material 136 may be a hydrophilic material
capable of absorbing fluid. The absorbent material 136 may be a
separate and distinct component coupled with the sealing material
134 as described herein to provide the sealing drape 101. In some
embodiments, the absorbent material 136 may comprise a
super-absorbent material. For example, the absorbent material 136
may comprise one or more super-absorbent materials, such as, for
example, carboxymethyl cellulose (CMC) or a carboxymethylcellulose
salt, a cross-linked hydrophilic acrylic or a cross-linked
hydrophilic acrylic salt, or an acrylamide.
[0042] When coupled with the sealing material 134, the absorbent
material 136 may provide an absorption gradient to draw or
otherwise wick fluid away from the tissue site 102. Fluid from the
tissue site 102 may be drawn by the absorption gradient through the
sealing material 134 and then be absorbed by the absorbent material
136. The absorbent material 136 may retain or bond to the fluid in
conjunction with a physical or chemical change to the absorbent
material 136. The absorbent material 136 may, for example, gel,
increase in viscosity, or otherwise thicken upon contact with fluid
from the tissue site 102, thereby trapping the fluid. The wicking
properties of the absorbent material 136 may quickly draw fluid
away from the tissue site 102, and thus, may prevent the
accumulation of fluid at or near the tissue site 102. In a similar
manner, the sealing material 134 may facilitate the evaporation of
fluid absorbed by the absorbent material 136 or otherwise
transferred through the sealing material 134 towards the external
surface 130 of the sealing drape 101. Since fluid from the tissue
site 102 may pass through the sealing material 134 to reach the
absorbent material 136 as described above, the sealing material 134
may provide a separation between the tissue site 102 and the
absorbent material 136. Thus, the sealing material 134 may be
positioned between the interior surface 132 of the sealing drape
101 and the absorbent material 136. Further, the sealing material
134 may substantially preclude fluid that has been absorbed by the
absorbent material 136 from contacting the tissue site 102 and the
peripheral surface 128.
[0043] The sealing material 134 may have any size, shape, or
thickness depending on a variety of factors, such as the type of
treatment being implemented, the nature of the tissue site 102, or
the peripheral surface 128. The thickness of the sealing material
134 may be increased or decreased to optimize the effectiveness of
the sealing material 134 as a separator between the tissue site 102
and the absorbent material 136. For example, in applications in
which the tissue site 102 is expected to release a large amount of
fluid, a thicker sealing material 134 may be desirable to restrain
or prevent the fluid from contacting the tissue site 102 or the
peripheral surface 128. Conversely, a thinner sealing material 134
may be desirable in applications in which a lower amount of fluid
is present. For example, the sealing material 134 may be between
about 100 micrometers to about 200 micrometers in thickness. The
thickness of the sealing material 134 may also be adjusted
according to a desired ratio of the sealing material 134 to the
absorbent material 136 comprising the sealing drape 101 depending
on the application. In some embodiments, the overall thickness of
the sealing drape 101 including the sealing material 134 and the
absorbent material 136 may be about 250 micrometers.
[0044] The absorbent material 136 may be dispersed throughout
and/or embedded as a sheet-like layer within the sealing material
134. FIG. 2 illustrates an embodiment of a sealing drape 201 that
may include the sealing material 134 having absorbent particles 236
dispersed throughout the sealing drape 201. The absorbent particles
236 may provide the previously described absorbent material 136.
The absorbent particles 236 may have any size or shape, depending
on a variety of factors, such as the nature of the tissue site 102
or the amount of fluid anticipated to be released by the tissue
site 102. In applications in which the tissue site 102 releases a
large amount of fluid, larger absorbent particles 236 may be
desirable to provide adequate absorptive capacity for the
fluid.
[0045] FIG. 3 illustrates another embodiment of a sealing drape 301
in which absorbent fibers 336, such as elongate tubes, are
dispersed throughout the sealing material 134. The absorbent fibers
336 may provide the previously described absorbent material 136.
The absorbent fibers 336 may have any size or shape, depending on a
variety of factors including the amount of fluid anticipated to be
released by the tissue site 102. This specification contemplates
embodiments including a mixture of absorbent particles 236 and
absorbent fibers 336 dispersed within the sealing material 134 as
described herein.
[0046] FIG. 4 illustrates another embodiment of a sealing drape 401
in which the absorbent material 136 comprises an absorbent layer
436 positioned within the sealing material 134. The sealing drape
401 may include a first layer 134a of the sealing material 134 and
a second layer 134b of the sealing material 134. The absorbent
layer 436 may be positioned between the first layer 134a and the
second layer 134b. The first layer 134a, the second layer 134b, and
the absorbent layer 436 may each have the same or a different
thickness. Thus, the absorbent layer 436 may be disposed at varying
distances from the external surface 130 of the sealing drape 401
and the interior surface 132 of the sealing drape 401 depending on
the thickness of each of the first and the second layer 134a,
134b.
[0047] The absorbent layer 436 may be provided as a nonwoven or a
woven structure. For example, the absorbent layer 436 may comprise
a nonwoven or a woven sheet of CMC fibers. Spaces or voids in the
absorbent layer 436 may allow a reduced pressure that is applied to
the reduced-pressure dressing 112 to be transferred within and
through the absorbent layer 436.
[0048] Further, the absorbent layer 436 may have any size, shape,
or thickness, depending on a variety of factors, such as the type
of treatment being implemented or the nature of the tissue site
102. The size and shape of the absorbent layer 436 may be
customized by a user to extend through a particular portion of the
sealing drape 401. Thus, the absorbent layer 436 may be designed to
cover a particular portion of the tissue site 102 or nearby tissue.
For example, the width or thickness of the absorbent layer 436 may
be increased to cause a corresponding increase in fluid storage
capacity of the absorbent layer 436.
[0049] Referring to FIGS. 2-3, in some embodiments, the absorbent
particles 236 and/or the absorbent fibers 336 may be dispersed or
otherwise disposed throughout the sealing material 134 in a
substantially uniform manner. A substantially uniform dispersion of
the absorbent particles 236 and/or the absorbent fibers 336 may
reduce the distance fluid must travel from the interior surface 132
before being absorbed. As described below, in some embodiments,
utilizing a configuration for the sealing drape 101 that employs
the absorbent particles 236 and/or the absorbent fibers 336 and/or
the absorbent layer 436 may allow a user to customize the
absorption gradient through the cross section of the sealing drape
101 for a desired application. Further, in some embodiments, the
absorbent particles 236 and/or the absorbent fibers 336 may be
dispersed or otherwise disposed within the sealing material 134 at
a desired concentration and location within the sealing drape 101
to suit a particular application.
[0050] FIG. 5 illustrates another embodiment of a sealing drape 501
that may have a plurality of the previously described absorbent
materials 236, 336, 436 configured as described above with the
sealing material 134. The absorbent materials 236, 336, 436 may be
configured with the sealing member 134 as described, and positioned
in layers relative to one another within the sealing drape 501.
Further, the absorbent materials 236, 336, 436 may have the same or
different dimensions and include the same or different absorbent
properties. In some embodiments, the plurality of absorbent
materials 236, 336, 436 may increase in concentration with
increasing distance from the interior surface 132 of the sealing
drape 501 through the cross section of the sealing drape 501, such
as, for example, from the interior surface 132 toward the external
surface 130. Similarly, the sealing drape 501 may have a higher
ratio of the absorbent material 236, 336, 436 to the sealing
material 134 with increasing distance from the interior surface
132. In some embodiments, the absorbent materials 236, 336, 436 may
exhibit increasing hydrophilicity or absorbency with increasing
distance from the interior surface 132. Further, in some
embodiments, the plurality of absorbent materials 236, 336, 436 may
be disposed within the sealing drape 501 such that the absorbent
materials 236, 336, 436 positioned farthest from the interior
surface 132 absorb more fluid than those closer to the interior
surface 132. For example, the absorbent layer 436 positioned
furthest away from the interior surface 132, as shown in FIG. 5,
may have a higher fluid storage capacity than the absorbent
materials 336, 236 positioned successively closer to the interior
surface 132. In this manner, the plurality of absorbent materials
236, 336, 436 may provide a 3-dimensional network of absorbent
material to enhance the transfer of moisture away from the tissue
site 102 and to retain the moisture at a maximum distance away from
the tissue site 102. This configuration may be customized as
described to provide a desired absorptive gradient, Moisture Vapor
Transmission Rate (MVTR), and fluid storage capacity to suit a
particular application.
[0051] FIG. 6 illustrates another embodiment of a sealing drape 601
that may include the absorbent material 136 carried by a carrier
635. The carrier 635 including the absorbent material 136 may be
positioned within the sealing material 134. For example, similar to
the sealing drape 401, the sealing drape 601 may include the first
layer 134a and the second layer 134b of the sealing material 134.
The carrier 635 may be positioned as a layer between the first
layer 134a and the second layer 134b. Thus, the carrier 635 may
provide a support structure that carries the absorbent material
136. The carrier 635 may comprise any of a variety of shapes and
sizes, and may comprise any suitable nonwoven or woven material. In
some embodiments, the carrier 635 may comprise a nonwoven
hydrophobic polypropylene material that is formed into a sheet-like
structure. The carrier 635 may provide support and strength for the
absorbent material 136. In some embodiments, the absorbent material
136 may be dispersed within the carrier 635 as absorbent particles
236 and/or absorbent fibers 336.
[0052] The sealing drape 101, 201, 301, 401, 501, and 601 may be
self-sealing to the tissue site 102, or may require an additional
sealing device. As discussed above, in one embodiment, the sealing
material 134 of the sealing drape 101, 201, 301, 401, 501, and 601
may comprise a hydrophobic silicone elastomer, which may function
as a silicone adhesive and form a direct bond with the peripheral
surface 128 of the tissue site 102, the epidermis 106, or the
manifold 118.
[0053] In some embodiments, the reduced-pressure dressing 112 may
include an additional attachment device (not shown) to fluidly seal
the sealing drape 101, 201, 301, 401, 501, and 601 around the
tissue site 102. The attachment device may be affixed to the
interior surface 132 of the sealing drape 101, 201, 301, 401, 501,
and 601 and may fluidly seal the sealing drape 101, 201, 301, 401,
501, and 601 to the epidermis 106 to provide the sealed space 123
surrounding the tissue site 102. The attachment device may cover at
least a portion of the interior surface 132 of the sealing drape
101, 201, 301, 401, 501, and 601. Attachment devices may include,
without limitation, a medically acceptable, pressure-sensitive
adhesive that extends about a periphery, a portion of, or the
entire sealing drape 101, 201, 301, 401, 501, and 601, a
double-sided drape tape, paste, hydrocolloid, hydrogel, or similar
sealing device. In this manner, the sealing drape 101, 201, 301,
401, 501, and 601 may be adapted to adhere to the peripheral
surface 128 to secure the reduced-pressure dressing 112 to the
tissue site 102.
[0054] In an illustrative embodiment of operation, the
reduced-pressure treatment system 100 may be applied to a patient
in the operating room after a surgical procedure or elsewhere. For
example, the manifold 118 may be placed proximate to, within,
overlying, or in contact with the tissue site 102. The sealing
drape 101, 201, 301, 401, 501, and 601 may be placed over or
otherwise covering the manifold 118 such that a portion of the
sealing drape 101, 201, 301, 401, 501, and 601 overlays the
peripheral surface 128 around the tissue site 102. The sealing
drape 101, 201, 301, 401, 501, and 601 may be secured to the
peripheral surface 128 in order to form a fluid seal between the
tissue site 102 and the sealing drape 101, 201, 301, 401, 501, and
601. The fluid seal need only be adequate to allow the
reduced-pressure treatment system 100 to maintain a reduced
pressure on the tissue site 102 for a desired treatment time. The
individual components of the reduced-pressure dressing 112 may be
sized according to the particular application or the procedure
being performed by a healthcare provider. For example, the
components of the reduced-pressure dressing 112 may be sized,
shaped, and configured to work in different anatomical applications
such as the abdomen, chest, thighs, hip, and other locations.
[0055] The reduced-pressure interface 122 may be fluidly coupled to
the sealing drape 101, 201, 301, 401, 501, and 601 before or after
the installation of the sealing drape 101, 201, 301, 401, 501, and
601. The reduced-pressure conduit 116 may be fluidly coupled to the
reduced-pressure interface 122. The reduced-pressure interface 122
may also be omitted and the reduced-pressure conduit 116 may be
directly inserted into the sealing drape 101, 201, 301, 401, 501,
and 601 in fluid communication with the sealed space 123. The
reduced-pressure conduit 116 may be fluidly coupled to the
reduced-pressure source 114. The reduced-pressure source 114 may be
activated to deliver reduced pressure to the sealed space 123
provided by the sealing drape 101, 201, 301, 401, 501, and 601
surrounding the tissue site 102. In some embodiments, the
reduced-pressure source 114 may be a micro-pump in or on the
reduced-pressure dressing 112.
[0056] Upon application of the reduced pressure to the
reduced-pressure dressing 112, exudates or other fluids from the
tissue site 102 may be drawn into the manifold 118, the sealing
drape 101, 201, 301, 401, 501, and 601, and through the
reduced-pressure interface 122. As fluids are drawn from the tissue
site 102, the peripheral surface 128 as well the components of the
reduced-pressure dressing 112 may become moist, including the
interior surface 132 of the sealing drape 101, 201, 301, 401, 501,
and 601 where the sealing drape 101, 201, 301, 401, 501, and 601
contacts the peripheral surface 128 around the tissue site 102.
Because of the ability of the sealing drape 101, 201, 301, 401,
501, and 601 to transfer moisture away from the peripheral surface
128 of the tissue site 102, the sealing drape 101, 201, 301, 401,
501, and 601 may maintain a fluid seal with the tissue site 102.
The sealing drape 101, 201, 301, 401, 501, and 601 may allow fluid
to pass through the interior surface 132 of the sealing drape 101,
201, 301, 401, 501, and 601 to reach the absorbent material 136
contained within the sealing material 134 of the sealing drape 101,
201, 301, 401, 501, and 601, thus helping to prevent saturation of
the tissue site 102 and possible maceration.
[0057] This specification also provides methods of manufacturing
the sealing drape 101, 201, 301, 401, 501, and 601 for use with the
reduced-pressure treatment system 100. In some embodiments, the
method may include the steps of providing the sealing material 134,
and disposing the absorbent material 136 within the sealing
material 134. The absorbent material 136 may be the previously
described absorbent particles 236, the absorbent fibers 336, the
absorbent layer 436, or any combination thereof.
[0058] In embodiments utilizing the absorbent particles 236 and the
absorbent fibers 336, such as the sealing drape 201, 301, the
method may include the step of mixing the absorbent particles 236
and/or the absorbent fibers 336 within the sealing material 134
prior to curing or otherwise solidifying the sealing material 134.
The method may further include the steps of forming the mixture of
the absorbent particles 236 and/or the absorbent fibers 336 into a
desired shape, such as a sheet, and curing or otherwise solidifying
the mixture. In some embodiments, the absorbent particles 236
and/or the absorbent fibers 336 may be mixed within the sealing
material 134 to provide a substantially uniform dispersion of the
absorbent particles 236 and/or the absorbent fibers 336 within the
sealing material 134. In some embodiments, the absorbent particles
236 and/or the absorbent fibers 336 may be mixed within the sealing
material 134 to provide a desired concentration of the absorbent
particles 236 and/or the absorbent fibers 336 within the sealing
material 134 at desired location therein.
[0059] In embodiments utilizing the absorbent layer 436, such as
the sealing drape 401, the method may include the steps of
providing the first layer 134a of the sealing material 134 and
providing the second layer 134b of the sealing material 134. The
method may additionally include the steps of providing the
absorbent layer 436, positioning the absorbent layer 436 between
the first and the second layer 134a, 134b, and enclosing the first
and the second layer 134a, 134b about the absorbent layer 436. In
other embodiments, multiple layers of the sealing material 134 and
the absorbent layers 436 may be utilized to suit a particular
application.
[0060] In embodiments utilizing the carrier 635, such as the
sealing drape 601, the method may include the step of carrying the
absorbent material 136, such as the absorbent particles 236 and/or
the absorbent fibers 336, with the carrier 635. For example, the
absorbent particles 236 and/or the absorbent fibers 336 may be
applied to the carrier 635 for support and retention by the
previously described non-woven or woven structure of the carrier
635. The method may additionally include the steps of providing the
first layer 134a of the sealing material 134, and providing the
second layer 134b of the sealing material 134. Further, the method
may include the steps of positioning the carrier 635, including the
absorbent material 136, between the first and the second layer
134a, 134b, and enclosing the first and the second layer 134a, 134b
about the carrier 635. In some embodiments, multiple layers of the
sealing material 134 and the carrier 635, including the absorbent
material 136, may be utilized to suit a particular application.
[0061] Although the treatment system 100 has been disclosed in the
context of certain illustrative, non-limiting embodiments, various
changes, substitutions, permutations, and alterations can be made
without departing from the scope of this specification as defined
by the appended claims. Any feature described in connection to any
one embodiment may also be applicable to any other embodiment.
* * * * *