U.S. patent application number 16/901948 was filed with the patent office on 2020-10-22 for tissue treatment systems and methods having a porous substrate with a compressed region and an expanded region.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Timothy Mark ROBINSON.
Application Number | 20200330283 16/901948 |
Document ID | / |
Family ID | 1000004887410 |
Filed Date | 2020-10-22 |
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United States Patent
Application |
20200330283 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
October 22, 2020 |
Tissue Treatment Systems And Methods Having A Porous Substrate With
A Compressed Region And An Expanded Region
Abstract
A system for treating a tissue site of a patient includes a
dressing filler adapted to be positioned at the tissue site. The
dressing filler is comprised of a porous substrate having at least
one compressed region and at least one expanded region. The
compressed region of the porous substrate is held in a compressed
state by a first coating capable of dissolving in the presence of a
fluid, and the expanded region of the porous substrate is held in
an expanded state by a second coating.
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: |
1000004887410 |
Appl. No.: |
16/901948 |
Filed: |
June 15, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15488156 |
Apr 14, 2017 |
10716711 |
|
|
16901948 |
|
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|
|
13678459 |
Nov 15, 2012 |
9655807 |
|
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15488156 |
|
|
|
|
61561631 |
Nov 18, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 13/00029 20130101;
A61L 2420/08 20130101; A61M 1/0088 20130101; A61F 2013/00314
20130101; A61F 13/00068 20130101; A61H 7/001 20130101; A61L 15/62
20130101; A61L 15/24 20130101; A61L 15/28 20130101; A61L 15/42
20130101; A61F 13/00008 20130101; A61L 15/26 20130101; A61L 15/425
20130101 |
International
Class: |
A61F 13/00 20060101
A61F013/00; A61H 7/00 20060101 A61H007/00; A61L 15/42 20060101
A61L015/42; A61L 15/62 20060101 A61L015/62; A61L 15/24 20060101
A61L015/24; A61L 15/26 20060101 A61L015/26; A61L 15/28 20060101
A61L015/28; A61M 1/00 20060101 A61M001/00 |
Claims
1. A system for treating a tissue site of a patient, the system
comprising: a dressing filler having a wound-facing surface adapted
to be positioned at the tissue site, the dressing filler comprising
a porous substrate including at least one compressed region
initially held away from a relaxed state and in a compressed state,
wherein a profile of the wound-facing surface is configured to
change when the at least one compressed region expands from the
compressed state to the relaxed state; a cover configured to create
a sealed space containing the dressing filler at the tissue site;
and a reduced pressure source configured to be in fluid
communication with the sealed space.
2. The system of claim 1, wherein the at least one compressed
region is held away from the relaxed state and in the compressed
state by a coating, and wherein the at least one compressed region
is configured to expand upon removal of the coating.
3. The system of claim 1, wherein a volume of the porous substrate
increases when the compressed region expands.
4. The system of claim 1, wherein the porous substrate is an
open-cell, reticulated foam.
5. The system of claim 1, wherein the porous substrate is a
polyurethane foam.
6. The system of claim 2, wherein the coating is a first coating,
wherein the porous substrate comprises at least one expanded region
in which the porous substrate is held away from the relaxed state
and in an expanded state by a second coating, and wherein the wound
facing-surface further includes a protrusion associated with the at
least one expanded region when the at least one expanded region is
in the expanded state.
7. The system of claim 6, wherein the first coating is the same as
the second coating.
8. The system of claim 2, wherein the coating is configured to be
removed from the at least one compressed region in a presence of
exudate from the tissue site.
9. The system of claim 2, wherein the coating is a starch.
10. The system of claim 2, wherein the coating is polyvinyl
alcohol.
11. The system of claim 2, wherein the coating is a polymer.
12. The system of claim 1, wherein the at least one compressed
region is arranged in a horizontal layer such that upon expansion
of the at least one compressed region, a force produced by the
expansion of the least one compressed region redistributes a load
on the tissue site.
13. The system of claim 12, further comprising a plurality of nodes
at the wound-facing surface, wherein the plurality of nodes are
configured to move along the tissue site from a first position when
the at least one compressed region is in the compressed state to a
second position when the at least one compressed region expands
from the compressed state to the relaxed state.
14. The system of claim 1, wherein the wound-facing surface
includes an indentation associated with the at least one compressed
region when the at least one compressed region is in the compressed
state.
15. The system of claim 14, wherein when the at least one
compressed region expands from the compressed state to the relaxed
state, the profile of the wound-facing surface is configured to
change such that the indentation associated with the at least one
compressed region in the compressed state decreases as the at least
one compressed region expands to the relaxed state.
16. The system of claim 1, wherein the at least one compressed
region is configured to expand from the compressed state to the
relaxed state in the presence of exudate from the tissue site.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/488,156, filed Apr. 14, 2017, entitled
"Tissue Treatment Systems and Methods Having a Porous Substrate
With a Compressed Region and an Expanded Region," which is a
divisional of U.S. patent application Ser. No. 13/678,459, filed
Nov. 15, 2012, now U.S. Pat. No. 9,655,807, entitled "Tissue
Treatment Systems and Methods Having a Porous Substrate With a
Compressed Region and an Expanded Region," which claims priority to
U.S. Provisional Patent Application No. 61/561,631, filed Nov. 18,
2011, entitled "Tissue Treatment Systems and Methods Having a
Porous Substrate With a Compressed Region and an Expanded Region,"
the disclosures of which are hereby incorporated by reference in
their entirety.
BACKGROUND
1. Field
[0002] This specification relates generally to tissue treatment
systems and more particularly, but without limitation, to a reduced
pressure tissue treatment system having a porous substrate with a
compressed region and an expanded region.
2. Description of Related Art
[0003] Clinical studies and practice have shown that providing a
reduced pressure in proximity to a tissue site augments and
accelerates the growth of new tissue at the tissue site. The
applications of this phenomenon are numerous, but one particular
application of reduced pressure involves treating wounds. This
treatment (frequently referred to in the medical community as
"negative pressure wound therapy," "reduced pressure therapy," or
"vacuum therapy") provides a number of benefits, including
migration of epithelial and subcutaneous tissues, improved blood
flow, and micro-deformation of tissue at the wound site. Together
these benefits result in increased development of granulation
tissue and faster healing times. Typically, reduced pressure is
applied by a reduced pressure source to tissue through a porous pad
or other manifold device. The porous pad contains cells or pores
that are capable of distributing reduced pressure to the tissue and
channeling fluids that are drawn from the tissue. The porous pad
often is incorporated into a dressing having other components that
facilitate treatment.
SUMMARY
[0004] The problems presented by existing reduced pressure
treatment systems are solved by the systems and methods of the
illustrative embodiments described herein. In one illustrative
embodiment, a system for treating a tissue site of a patient is
provided. The system includes a dressing filler adapted to be
positioned at the tissue site. The dressing filler is comprised of
a porous substrate having at least one compressed region and at
least one expanded region. The compressed region of the porous
substrate is held in a compressed state by a first coating capable
of dissolving in the presence of a fluid, and the expanded region
of the porous substrate is held in an expanded state by a second
coating.
[0005] In another embodiment, a system for treating a tissue site
of a patient includes a dressing filler adapted to be positioned at
the tissue site. The dressing filler is comprised of a porous foam
having a textured wound-facing surface, the wound-facing surface
having at least one compressed region in which the foam is held in
a compressed state by a first coating. The wound-facing surface
includes at least one relaxed region in which the foam is neither
compressed nor expanded but rather is in a relaxed state. The
porous foam includes at least one expanded region positioned above
the at least one relaxed region. The expanded region is held in an
expanded state by a second coating.
[0006] In yet another embodiment, a system for treating a tissue
site of a patient includes a dressing filler adapted to be
positioned at the tissue site. The dressing filler is comprised of
a porous substrate having at least one compressed region held in a
compressed state by a coating capable of being removed in the
presence of a fluid. The system further includes a cover adapted
for positioning over the dressing filler to create a sealed space
beneath the cover and a reduced pressure source configured for
fluid communication with the sealed space.
[0007] Other objects, 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
[0008] FIGS. 1A and 1B illustrate a partially cross-sectional,
perspective view of a tissue treatment system according to an
illustrative embodiment, the tissue treatment system having a
dressing filler;
[0009] FIG. 2 illustrates a front view of the dressing filler of
the tissue treatment system of FIG. 1A, the dressing filler having
a plurality of compressed regions in a compressed state and a
plurality of expanded regions in an expanded state;
[0010] FIG. 3 illustrates a front view of the dressing filler of
FIG. 2, both the compressed regions and the expanded regions being
illustrated in a relaxed state;
[0011] FIG. 4 illustrates a schematic front view of a dressing
filler according to an illustrative embodiment, the dressing filler
having a compressed region in a compressed state and an expanded
region in an expanded state;
[0012] FIG. 5 illustrates a schematic front view of the dressing
filler of FIG. 4, the compressed region and the expanded region
being illustrated in a relaxed state;
[0013] FIG. 6 illustrates a front perspective view of a rack having
a plurality of pins for insertion into a porous substrate to form
compressed regions or expanded regions within the porous
substrate;
[0014] FIG. 7 illustrates the rack of FIG. 6 with the pins of the
rack inserted into the porous substrate prior to the compressed
region being compressed and prior to the expanded region being
expanded;
[0015] FIG. 8 illustrates the rack of FIG. 6 with the pins of the
rack inserted into the porous substrate, the porous substrate being
illustrated subsequent to the compressed region being compressed
and subsequent to the expanded regions being expanded;
[0016] FIG. 9 illustrates a front view of a dressing filler
according to an illustrative embodiment, the dressing filler have a
plurality of compressed regions in a compressed state and a
plurality of expanded regions in an expanded state;
[0017] FIG. 10 illustrates a front view of the dressing filler of
FIG. 9, the compressed and expanded regions being illustrated in a
relaxed state;
[0018] FIG. 11 illustrates a front view of a dressing filler
according to an illustrative embodiment, the dressing filler have a
compressed region in a compressed state; and
[0019] FIG. 12 illustrates a front view of the dressing filler of
FIG. 11, the compressed region being illustrated in a relaxed
state.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0020] In the following detailed description of several
illustrative embodiments, reference is made to the accompanying
drawings that form a part hereof, and in which is shown by way of
illustration specific preferred embodiments in which the subject
matter of this specification may be practiced. These embodiments
are described in sufficient detail to enable those skilled in the
art to practice the disclosed subject matter, and it is understood
that other embodiments may be utilized and that 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 description may omit
certain information known to those skilled in the art. The
following detailed description is, therefore, not to be taken in a
limiting sense, and the scope of the illustrative embodiments are
defined only by the appended claims. Unless otherwise indicated, as
used herein, "or" does not require mutual exclusivity.
[0021] The term "reduced pressure" as used herein generally refers
to a pressure less than the ambient pressure at a tissue site that
is being subjected to treatment. In most cases, this reduced
pressure will be less than the atmospheric pressure at which the
patient is located. Alternatively, the reduced pressure may be less
than a hydrostatic pressure associated with tissue at the tissue
site. Although the terms "vacuum" and "negative pressure" may be
used to describe the pressure applied to the tissue site, the
actual pressure reduction applied to the tissue site may be
significantly less than the pressure reduction normally associated
with a complete vacuum. Reduced pressure may initially generate
fluid flow in the area of the tissue site. As the hydrostatic
pressure around the tissue site approaches the desired reduced
pressure, the flow may subside, and the reduced pressure is then
maintained. Unless otherwise indicated, values of pressure stated
herein are gauge pressures. Similarly, references to increases in
reduced pressure typically refer to a decrease in absolute
pressure, while decreases in reduced pressure typically refer to an
increase in absolute pressure.
[0022] The tissue treatment systems and methods described herein
improve the treatment of a tissue site by providing a porous
substrate that is used in conjunction with reduced pressure tissue
treatment. The porous substrate includes a wound-facing surface
that is capable of contacting the tissue site and creating
microstrain at the tissue site. The microstrain is created by the
force applied to the tissue site by the wound-facing surface of the
porous substrate. When the porous substrate is an open-celled foam,
the force is transmitted to the tissue site by the cell walls or
struts of the foam. The application of force to the porous
substrate produces a force distribution that provides forces to the
tissue site at any point that is contacted by the porous substrate.
This force distribution therefore results in a particular
microstrain distribution, which of course will vary based on the
porosity and other characteristics of the porous substrate, as well
as how the porous substrate is positioned at the tissue site. Since
microstrain at the tissue site assists in the development of new
granulation tissue, it is beneficial to vary the distribution of
force and microstrain during treatment such that a more even
development of granulation tissue is obtained.
[0023] Referring to FIGS. 1A and 1B, an illustrative embodiment of
a reduced pressure tissue treatment system 100 for treating a
tissue site 101 on a patient includes a dressing 102 placed
proximate to the tissue site 101 and a therapy unit 104 fluidly
coupled to the dressing 102. As used herein, the term "tissue site"
may refer to a wound, such as 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. The term "tissue site" may further 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 tissue
treatment may be used in certain tissue areas to grow additional
tissue that may be harvested and transplanted to another tissue
location.
[0024] The dressing 102 is configured to promote the growth of new
tissue at the tissue site 101 and includes a dressing filler 106
positioned adjacent to or, in some embodiments, in contact with the
tissue site 101. The dressing 102 may further include a cover 110
or drape positioned over the dressing filler 106 to secure the
dressing filler 106 at the tissue site 101 and to seal a space that
is located beneath the cover and that is at least partially
occupied by the dressing filler 106. In one embodiment, the cover
110 extends beyond a perimeter of the tissue site 101 and is placed
either in contact with or otherwise in proximity to a patient's
epidermis 113 to create a fluid seal between the cover 110 and the
epidermis 113. The cover 110 may include an adhesive 115 or bonding
agent to secure the cover 110 to the epidermis 113. In one
embodiment, the adhesive 115 may be used to create a seal between
the cover 110 and the epidermis 113 to prevent leakage of reduced
pressure from the tissue site 101. In another embodiment, a seal
layer (not shown) such as, for example, a hydrogel or other
material may be disposed between the cover 110 and the epidermis
113 to augment or substitute for the sealing properties of the
adhesive 115. As used herein, "fluid seal" means a seal adequate to
maintain reduced pressure at a desired site given the particular
reduced pressure source involved and the particular treatment
desired. In one embodiment, the cover 110 and the bonding
characteristics of the cover 110 provide sealing sufficient to
prevent leakage greater than 0.5 L/min at 125 mmHg reduced
pressure.
[0025] The dressing 102 further may include a reduced pressure
adapter or interface 116 fluidly coupled to the space beneath the
cover 110. In one embodiment, the interface 116 may be positioned
adjacent to or coupled to the cover 110 to provide fluid access to
the dressing filler 106 and the tissue site 101. The cover 110
includes an aperture 118 for providing fluid access to the
interface 116. A conduit 120 fluidly couples the therapy unit 104
and the interface 116. The interface 116 is capable of delivering
reduced pressure to the tissue site 101.
[0026] In one embodiment, the therapy unit 104 includes a fluid
containment member 122 in fluid communication with a reduced
pressure source 124. In the embodiment illustrated in FIG. 1, the
fluid containment member 122 is a collection canister that includes
a chamber for collecting fluids from the tissue site 101. The fluid
containment member 122 alternatively could be an absorbent material
or any other container, device, or material that is capable of
collecting fluid.
[0027] The conduit 120 may be a multi-lumen tube that is capable of
providing one or more conduits to deliver reduced pressure to the
dressing 102 and one or more conduits to sense the amount of
pressure at the tissue site 101. Liquids or exudates communicated
from the dressing filler 106 through the conduit 120 are removed
from the conduit 120 and retained within the collection canister
122.
[0028] Referring still to FIG. 1A, the reduced pressure source 124
may be an electrically-driven vacuum pump. In another
implementation, the reduced pressure source 124 instead may be a
manually-actuated or manually-charged pump that does not require
electrical power. In one embodiment, the reduced pressure source
124 may be one or more piezoelectric-actuated micropumps that may
be positioned remotely from the dressing 102, or at the dressing
beneath or adjacent to the cover 110. The reduced pressure source
124 instead may be any other type of pump, or alternatively a wall
suction port or air delivery port such as those available in
hospitals and other medical facilities. The reduced pressure source
124 may be housed within or used in conjunction with the therapy
unit 104, which may also contain sensors, processing units, alarm
indicators, memory, databases, software, display units, and user
interfaces 126 that further facilitate the application of reduced
pressure treatment to the tissue site 101. In one example,
pressure-detection sensors (not shown) may be disposed at or near
the reduced pressure source 124. The pressure-detection sensors may
receive pressure data from the interface 116 via lumens in the
conduit 120 that are dedicated to delivering reduced pressure data
to the pressure-detection sensors. The pressure-detection sensors
may communicate with a processing unit that monitors and controls
the reduced pressure that is delivered by the reduced pressure
source 124.
[0029] In the embodiment illustrated in FIGS. 1A and 1B, the
dressing filler 106 comprises a porous substrate that may be in one
embodiment a porous foam. More specifically, the porous substrate
may be an open-celled foam such as the open-celled, reticulated
polyurethane foam sold under the name GRANUFOAM.RTM. by Kinetic
Concepts, Inc. of San Antonio, Tex. Alternatively, a
non-reticulated foam or a foam comprised of biocompatible materials
other than polyurethane may be used. In one embodiment, a
bioabsorbable foam or other porous substrate may be employed.
Examples of other materials that may be suitable porous foams or
porous substrates include those formed from acrylics, acrylates,
thermoplastic elastomers (for example, styrene ethylene butene
styrene (SEBS) and other block copolymers), polyether block
polyamide (PEBAX), silicone elastomers, poly caprolactam, poly
lactic acid, and polyolefins, such as polythene and polypropylene.
Still other biocompatible materials may be used if capable of being
formed or otherwise made into a porous substrate as described
herein.
[0030] The porous substrate preferably includes a plurality of
openings or other flow channels that facilitate movement of fluids
and distribution of reduced pressure in the sealed space beneath
the cover. In an embodiment employing a foam such as the
reticulated, polyurethane foam, the flow channels are provided by
openings 125 or cells within the foam. The foam further may include
cell walls or struts 126 that form a framework for the openings 125
(see FIG. 1B). The struts 126 press upon the tissue site 101 when a
force is applied to the dressing filler 106, thereby creating
distribution of forces and microstrain at the tissue site 101 that
depends on the local positioning of the struts 126.
[0031] Referring still to FIGS. 1A and 1B, but also to FIGS. 2 and
3, the dressing filler 106 includes a plurality of first, or
compressed regions 130 and a plurality of second, or expanded
regions 134 arranged in vertically-oriented layers that extend from
a wound-facing surface 138 of the porous dressing filler 106 to an
opposing surface 142. The compressed regions 130 illustrated in
FIGS. 1A, 1B, and 2 are in a compressed state, while the same
compressed regions 130 illustrated in FIG. 3 are in a relaxed
state. Similarly the expanded regions 134 illustrated in FIGS. 1A,
1B, and 2 are in an expanded state, while the same expanded regions
134 illustrated in FIG. 3 are in a relaxed state. Referring more
specifically to FIG. 1B, the effect of compressing or expanding the
dressing filler 106 is depicted. When the compressed regions 130
are in the compressed state and the expanded regions 134 are in the
expanded state (as depicted in FIG. 1B), the density of struts per
unit volume in the compressed regions 130 is greater than the
density of struts 126 per unit volume in the expanded regions 134.
When the compressed regions 130 and the expanded regions 134 are in
the relaxed state (as depicted in FIG. 3), the density of struts
per unit volume in the compressed regions 130 is approximately
equal to the density of struts 126 per unit volume in the expanded
regions 134.
[0032] While the phrase "compressed region" has been used to
describe certain regions of the dressing filler 106 that are in
some cases compressed, the phrase also is capable of describing a
region that has assumed a relaxed state from a compressed state. In
some situations, due to the compression of the dressing filler 106
during reduced pressure tissue treatment, as is described more
fully herein, certain compressed regions may actually experience
expansion in certain directions when compared to the original
compressed state. Similarly, the "expanded region" is capable of
existing in multiple states, at least two of which are the expanded
state and the relaxed state. Again, it is conceivable during the
application of reduced pressure to the dressing filler 106 that
certain expanded regions may undergo some compression beneath the
cover 110.
[0033] In general, the description of the dressing filler 106 as
having a compressed state or an expanded state is meant to describe
the forces acting on the foam. When a region of the dressing filler
106 is in the compressed state, the forces acting on the region,
which are represented by arrows 150 in FIG. 2, are directed in an
outward direction such that the region, if not constrained, would
expand in at least one direction. When a region of the dressing
filler 106 is in the expanded state, the forces acting on the
region, which are represented by arrows 154 in FIG. 2, are directed
in an inward direction such that the region, if not constrained,
would contract in at least one direction. When a region of the
dressing filler 106 is in the relaxed state, no significant forces
are acting on the region.
[0034] Referring still to FIGS. 1A, 1B, and 2, the compressed
regions 130 are held or secured in the compressed state by a first
coating. Similarly, the expanded regions 134 are held or secured in
the expanded state by a second coating. In one embodiment, the
first and second coatings are the same coating. The first and
second coatings may be any material that is capable of securing the
dressing filler 106 in the compressed state or the expanded state
and that is then capable of being removed such that the dressing
filler 106 can change to a relaxed state. In one embodiment, the
first and second coatings may be capable of dissolving in the
presence of a fluid. Dissolvable coatings allow the coating to be
removed as exudate from the tissue site 101 enters the dressing
filler 106. Alternatively, a liquid such as a saline solution, or
any other biocompatible solvent or liquid, may be delivered to the
dressing filler 106 when it is desired to remove the first and
second coatings. Examples of coatings that may be used include
without limitation starches or other sugars, polyvinyl alcohol,
polyvinyl pyrrolidone, carboxy methyl cellulose (CMC) and its salts
and esters, alginates, gums such as guar and xanthan, or other
polymers. Water soluble salts or effervescing mixes (such as
tartaric acid and carbonate or bicarbonate salts) may be
incorporated into water insoluble polymers. When exposed to water
the water soluble salts are leached from the polymer, or in the
case of the effervescent mixes gas is released--in both cases
creating porosity in the carrier polymer, and weakening it,
allowing the physical form of the dressing filler to change. The
time period over which the coatings described herein may release
will vary depending on the desired treatment regimen. In one
embodiment, the coating may be configured to release as quickly as
within a few hours (e.g. 4 hours) or as long as a day or more.
[0035] The coatings may be positioned on the exterior surfaces of
the dressing filler 106 or alternatively may be used to coat both
exterior surfaces and the inner passages of the dressing filler
106. In one embodiment, it may be desirable to uniformly coat the
dressing filler 106 both externally and internally. Delivery of the
coating to the dressing filler 106 may be accomplished by dipping
the dressing filler 106 in the coating, or by spraying, brushing,
rolling, or otherwise applying the coating. In one embodiment, the
coating may be applied to a unitary dressing filler 106 that
includes regions that have been compressed and expanded.
Alternatively, the coating may be applied to separate pieces of
compressed or expanded material that are then assembled to build
the dressing filler 106. The attachment of multiple pieces to build
the dressing filler 106 may be accomplished by bonding, mechanical
fastening, welding, or any other attachment means.
[0036] Referring to FIG. 3, as the coating is removed, both
compressed and expanded regions are released and move toward a
relaxed state as shown in FIG. 3. In the relaxed state, assuming
the same type of dressing filler is used in both the compressed and
expanded regions, the density of openings and cell struts per unit
volume in the compressed regions will be approximately equal to the
density of openings and cell struts per unit volume in the expanded
regions. By compressing a particular compressed region the same
approximate amount as a corresponding expanded region is expanded,
the expansion of a compressed region to the relaxed state may be
offset by the contraction of an expanded region to the relaxed
state. In other words, when a dressing having expanded and
compressed regions moves to a relaxed state, the dressing undergoes
a net-zero volume change.
[0037] As an alternative to the coating, a removable sheath or
other covering may be placed around the dressing filler 106 when
the various regions have been charged to their appropriate
compressed or expanded states. The sheath may be a dissolvable or
bioabsorbable substance such as a woven or non-woven fabric,
polyvinyl pyrrolidone, carboxy methyl cellulose (CMC) and its salts
and esters, alginates, gums such as guar and xanthan, polyvinyl
alcohol, polycaprolactam, poly lactic acid and their copolymers or
blends, or other polymers or materials. In one embodiment, if a
sheath or other covering is used, the sheath may surround the
dressing filler 106 completely, or may partially surround a portion
of the dressing filler 106. If a dissolvable or bioabsorbable
sheath is employed, the particular material used and its thickness
may be chosen to provide release based on a desired time period.
For example, a sheath that will dissolve within 12 hours may be
chosen to provide treatment for up to 12 hours with the regions of
dressing filler 106 in the compressed and expanded states. In this
particular example, following dissolution of the sheath at or
around 12 hours allows the regions of the dressing filler 106 to
change to a relaxed state, thereby changing the microstrain profile
at the tissue site 101. In another embodiment, the sheath may
instead be manually removable from the dressing filler 106 by a
care giver or the patient when the change in microstrain profile is
desired.
[0038] Referring to FIGS. 4 and 5, a dressing filler 406 according
to an illustrative embodiment comprises a porous substrate that is
similar to the porous substrate described above with reference to
FIGS. 1-3. Dressing filler 406 further includes a compressed region
430 and an expanded region 434 similar to those previously
described. The dressing filler 406 also includes nodes 412 which
may be projections to transmit forces to a tissue site and thus
generate microstrain. Nodes 412 may also be representative of the
struts of dressing filler 106. Visualization of the nodes 412
illustrated in FIGS. 4 and 5 allows an understanding of how the
expansion of the compressed region 430 and the contraction of the
expanded region 434 benefit tissue site treatment and wound
healing. In FIG. 4, nodes 412 have a first position indicated by
nodes 412a. As the coating securing the compressed and expanded
regions 430, 434 is removed, the compressed region 430 expands and
the expanded region 434 contracts, which moves the nodes 412 to a
second position indicated by nodes 412b. As illustrated in FIG. 5,
the repositioning of the nodes 412 during the expansion and
contraction of certain regions of the dressing filler 406 allow a
spatial redistribution of the point loads applied by the nodes 412
to the tissue site. This in turn creates a different microstrain
profile (i.e. the distribution of microstrain) at the tissue site,
thereby aiding in the even development of granulation tissue and
preventing the adhesion of new tissue growth to the dressing filler
406.
[0039] Referring to FIGS. 6-8, a dressing filler 606 similar to
dressing fillers 106, 406 is illustrated prior to being placed into
a compressed or expanded state. To prepare the dressing filler 606
for use in tissue treatment, the dressing filler 606 is compressed
or expanded in sections or regions. In FIG. 6, a first region, or
compressed region 610 and a second region, or expanded region 614
are both illustrated in a relaxed state. A plurality of racks 622
each having a plurality of pins 626 are provided to provide the
necessary compression or expansion of the dressing filler 606. The
racks 622 are slidably positioned on one or more stringers 630 that
provide support for the racks 622 and constrain the racks to
movements along one axis. In other embodiments, racks may be
provided that allow movement, and thus compression or expansion of
the dressing filler, along multiple axes.
[0040] As more specifically illustrated in FIGS. 6 and 7, the
dressing filler is positioned on the pins 626 of the racks 622 such
that the pins 626 of at least two of the racks penetrate each
region 610, 614. To compress or expand each region 610, 614, the
racks 622 are slidably moved along the stringers 630 in the
directions illustrated by arrows 640, 644 in FIG. 7. To move the
compressed region 610 of the dressing filler 606 to a compressed
state, the two racks 622 associated with the compressed region 610
are moved toward one another as indicated by arrows 640. To move
the expanded region 614 of the dressing filler 606 to an expanded
state, the two racks 622 associated with the expanded region 614
are moved away from one another as indicated by arrows 644. The
movement of the racks 622 may be performed manually, or may instead
be hydraulically, pneumatically, electrically, or mechanically
driven.
[0041] Following the movement of the racks 622 in the directions
indicated by arrows 640, 644 the compressed region 610 is in the
compressed state and the expanded region 614 is in the expanded
sate (see FIG. 8). The regions 610, 614 of the dressing filler 606
may be held or secured in the compressed and expanded states by
applying a removable coating or sheath to the dressing filler 606
as previously described herein. After the dressing filler 606 has
been locked by the coating or sheath, the pins 626 of the racks 622
may be removed from the dressing filler 606.
[0042] FIGS. 6-8 provide only one example of how the various
regions of the dressing fillers described herein may be compressed
or expanded. Other devices that penetrate or contact the regions of
the dressing filler may be used to compress or expand the dressing
filler. While the examples described above provide a method for
compressing and expanding different portions of a unitary piece of
foam or porous substrate, the various regions that require
compression or expansion may instead by compressed or expanded
independently of one another and then joined together to form the
dressing filler. For example, in one embodiment, two pieces of a
porous foam in a relaxed state may be provided. One of the pieces
of porous foam may be compressed and secured in the compressed
state. The other piece of porous foam may be expanded and secured
in the expanded state. Following the steps of compressing or
expanding each piece of foam individually, the two pieces of foam
may be adhesively bonded, thermally coupled, mechanically attached,
ultrasonically welded, or otherwise connected to form a unitary
dressing filler.
[0043] Referring to FIGS. 9 and 10, a dressing filler 906 according
to an illustrative embodiment is capable of being used with a
reduced pressure treatment system similar to reduced pressure
treatment system 100 of FIG. 1. The dressing filler 906 comprises a
porous substrate that may be in one embodiment a porous foam. More
specifically, the porous substrate may be an open-celled foam such
as the open-celled, reticulated polyurethane foam sold under the
name GRANUFOAM.RTM. by Kinetic Concepts, Inc. of San Antonio, Tex.
Alternatively, a non-reticulated foam or a foam comprised of
biocompatible materials other than polyurethane may be used. In one
embodiment, a bioabsorbable foam or other porous substrate may be
employed. Examples of other materials that may be suitable porous
foams or porous substrates include those formed from acrylics,
acrylates, thermoplastic elastomers (for example, styrene ethylene
butene styrene (SEBS) and other block copolymers), polyether block
polyamide (PEBAX), silicone elastomers, poly caprolactam, poly
lactic acid, and polyolefins, such as polythene and polypropylene.
Still other biocompatible materials may be used if capable of being
formed or otherwise made into a porous substrate as described
herein.
[0044] The porous substrate preferably includes a plurality of
openings or other flow channels that facilitate movement of fluids
and distribution of reduced pressure in the sealed space beneath
the cover. In an embodiment employing a foam such as the
reticulated, polyurethane foam, the flow channels are provided by
openings or cells within the foam similar to those described
previously with reference to FIGS. 1A and 1B. The foam further may
include cell walls or struts that form a framework for the openings
as previously described.
[0045] The dressing filler 906 includes a plurality of first, or
compressed regions 930 and a plurality of second, or expanded
regions 934 arranged in horizontally-oriented layers located
between a wound-facing surface 938 of the porous dressing filler
906 and an opposing surface 942. The compressed regions 930
illustrated in FIG. 9 are in a compressed state, while the same
compressed regions 930 illustrated in FIG. 10 are in a relaxed
state. Similarly the expanded regions 934 illustrated in FIG. 9 are
in an expanded state, while the same expanded regions 934
illustrated in FIG. 10 are in a relaxed state.
[0046] The forces acting on the compressed region 930 in the
compressed state are represented by arrows 950 in FIG. 9. These
particular forces are directed in an outward direction such that
the compressed region 930 in the compressed state, if not
constrained, would expand in at least one direction. The forces
acting on the expanded region 934 in the expanded state are
represented by arrows 954 in FIG. 9. These forces are directed in
an inward direction such that the expanded region 934 in the
expanded state, if not constrained, would contract in at least one
direction. When the compressed regions 930 or the expanded regions
934 of the dressing filler 906 are in the relaxed state (see FIG.
10), no significant forces are acting on the regions.
[0047] Referring still to FIG. 9, the compressed regions 930 are
held or secured in the compressed state by a first coating.
Similarly, the expanded regions 934 are held or secured in the
expanded state by a second coating. In one embodiment, the first
and second coatings are the same coating. The first and second
coatings may be any material that is capable of securing the
dressing filler 906 in the compressed state or the expanded state
and that is then capable of being removed such that the dressing
filler 906 may change to a relaxed state. In one embodiment, the
first and second coatings may be capable of dissolving in the
presence of a fluid. Dissolvable coatings allow the coating to be
removed as exudate from a tissue site enters the dressing filler
906. Alternatively, a liquid such as a saline solution, or any
other biocompatible solvent or liquid, may be delivered to the
dressing filler 906 when it is desired to remove the first and
second coatings. Examples of coatings that may be used include
without limitation starches or other sugars, polyvinyl alcohol,
polyvinyl pyrrolidone, carboxy methyl cellulose (CMC) and its salts
and esters, alginates, gums such as guar and xanthan, or other
polymers. Water soluble salts or effervescing mixes (such as
tartaric acid and carbonate or bicarbonate salts) may be
incorporated into water insoluble polymers. When exposed to water
the water soluble salts are leached from the polymer, or in the
case of the effervescent mixes gas is released--in both cases
creating porosity in the carrier polymer, and weakening it,
allowing the physical form of the dressing filler to change. The
time period over which the coatings described herein may release
will vary depending on the desired treatment regimen. In one
embodiment, the coating may be configured to release as quickly as
within a few hours (e.g. 4 hours) or as long as a day or more.
[0048] The coatings may be positioned on the exterior surfaces of
the dressing filler 906 or alternatively may be used to coat both
exterior surfaces and the inner passages of the dressing filler
906. In one embodiment, it may be desirable to uniformly coat the
dressing filler 906 both externally and internally. Delivery of the
coating to the dressing filler 906 may be accomplished by dipping
the dressing filler 906 within the coating, or by spraying,
brushing, rolling, or otherwise applying the coating. In one
embodiment, the coating may be applied to a unitary dressing filler
906 that includes regions that have been compressed and expanded.
Alternatively, the coating may be applied to separate pieces of
compressed or expanded material that is then assembled to build the
dressing filler 906. The attachment of multiple pieces to build the
dressing filler 906 may be accomplished by bonding, mechanical
fastening, welding, or any other attachment means.
[0049] Prior to removal of the coating, the wound-facing surface
938 of the dressing filler 906 is irregular or non-planar, with
indentations 962 created by the compression of the compressed
regions 930. The wound-facing surface 938 further includes
protrusions 966 created by the expansion of the expanded regions
934. The location of the indentations 962 and protrusions 966 along
the wound-facing surface may form a regular grid-type or other
pattern, or may instead be more random in nature. While the
compressed regions 930 are located adjacent to and incorporate the
wound-facing surface 938, the compressed regions 930 could instead
be spaced apart from the wound-facing surface 938 and located
closer to opposing surface 942. Similarly, while the expanded
regions 934 are spaced apart from the wound-facing surface 938 and
are located closer to the opposing surface 942, the expanded
regions 934 could instead be positioned adjacent to and may even
incorporate the wound-facing surface 938.
[0050] Referring to FIG. 10, as the coating is removed, both the
compressed and expanded regions are released and move toward a
relaxed state as shown in FIG. 10. In the relaxed state, assuming
the same type of dressing filler is used in both the compressed and
expanded regions, the density of openings and cell struts per unit
volume in the compressed regions will be approximately equal to the
density of openings and cell struts per unit volume in the expanded
regions. The height of the expanded regions 934 typically decreases
as the expanded regions 934 move to the relaxed state, while the
height of the compressed regions 930 typically increases as the
compressed regions 930 move to the relaxed state. The change in
height of the compressed and expanded regions results in a change
in the profile of the wound-facing surface 938. While the
compressed regions 930 had previously been associated with
indentations 962 (see FIG. 9), the expansion of the compressed
regions 930 to the relaxed state results in the formation of
protrusions 970 (see FIG. 10). The expanded regions 934, which had
previously been associated with protrusions 966 (see FIG. 9),
contract to the relaxed state such that indentations 974 are formed
(see FIG. 10). This reversal of protrusions and indentations on the
wound-facing surface 938 changes the interface of the dressing
filler 906 with a tissue site and therefore is capable of changing
the distribution of loads and microstrain at the tissue site during
treatment.
[0051] As an alternative to the coating, a removable sheath or
other covering may be placed around the dressing filler 906 when
the various regions have been charged to their respective
compressed or expanded states. The sheath may be a dissolvable or
bioabsorbable substance such as a woven or non-woven fabric,
polyvinyl pyrrolidone, carboxy methyl cellulose (CMC) and its salts
and esters, alginates, gums such as guar and xanthan, polyvinyl
alcohol, polycaprolactam, poly lactic acid and their copolymers or
blends, or other polymers or materials. In one embodiment, if a
sheath or other covering is used, the sheath may surround the
dressing filler 906 completely, or may partially surround a portion
of the dressing filler 906. If a dissolvable or bioabsorbable
sheath is employed, the particular material used and its thickness
may be chosen to provide release based on a desired time period. In
another embodiment, the sheath may instead be manually removable
from the dressing filler 906 by a care giver or the patient when
the change in microstrain profile is desired.
[0052] Referring to FIGS. 11 and 12, a dressing filler 1106
according to an illustrative embodiment is capable of being used
with a reduced pressure treatment system similar to reduced
pressure treatment system 100 of FIG. 1. The dressing filler 1106
comprises a porous substrate that may be in one embodiment a porous
foam. More specifically, the porous substrate may be an open-celled
foam such as the open-celled, reticulated polyurethane foam sold
under the name GRANUFOAM.RTM. by Kinetic Concepts, Inc. of San
Antonio, Tex. Alternatively, a non-reticulated foam or a foam
comprised of biocompatible materials other than polyurethane may be
used. In one embodiment, a bioabsorbable foam or other porous
substrate may be employed. Examples of other materials that may be
suitable porous foams or porous substrates include those formed
from acrylics, acrylates, thermoplastic elastomers (for example,
styrene ethylene butene styrene (SEBS) and other block copolymers),
polyether block polyamide (PEBAX), silicone elastomers, poly
caprolactam, poly lactic acid, and polyolefins, such as polythene
and polypropylene. Still other biocompatible materials may be used
if capable of being formed or otherwise made into a porous
substrate as described herein.
[0053] The porous substrate preferably includes a plurality of
openings or other flow channels that facilitate movement of fluids
and distribution of reduced pressure in the sealed space beneath
the cover. In an embodiment employing a foam such as the
reticulated, polyurethane foam, the flow channels are provided by
openings or cells within the foam similar to those described
previously with reference to FIGS. 1A and 1B. The foam further may
include cell walls or struts that form a framework for the openings
as previously described.
[0054] The dressing filler 1106 includes one or more compressed
regions 1130 arranged in horizontally-oriented layers located
between a wound-facing surface 1138 of the porous dressing filler
1106 and an opposing surface 1142. The compressed region 1130
illustrated in FIG. 11 is in a compressed state, while the same
compressed region 1130 illustrated in FIG. 12 is in a relaxed
state. The forces acting on the compressed region 1130 in the
compressed state are represented by arrows 1150 in FIG. 11. These
particular forces are directed in an outward direction such that
the compressed region 1130 in the compressed state, if not
constrained, would expand in at least one direction. When the
compressed region 1130 of the dressing filler 1106 is in the
relaxed state (see FIG. 12), no significant forces act upon the
compressed region 1130.
[0055] Referring still to FIG. 11, the compressed region 1130 is
held or secured in the compressed state by a coating. The coating
may be any material that is capable of securing the dressing filler
1106 in the compressed state and that is then capable of being
removed such that the dressing filler 1106 may change to a relaxed
state. In one embodiment, the coating may be capable of dissolving
in the presence of a fluid. Dissolvable coatings allow the coating
to be removed as exudate from a tissue site enters the dressing
filler 1106. Alternatively, a liquid such as a saline solution, or
any other biocompatible solvent or liquid, may be delivered to the
dressing filler 1106 when it is desired to remove the coating.
Examples of coatings that may be used include without limitation
starches or other sugars, polyvinyl alcohol, polyvinyl pyrrolidone,
carboxy methyl cellulose (CMC) and its salts and esters, alginates,
gums such as guar and xanthan, or other polymers. Water soluble
salts or effervescing mixes (such as tartaric acid and carbonate or
bicarbonate salts) may be incorporated into water insoluble
polymers. When exposed to water the water soluble salts are leached
from the polymer, or in the case of the effervescent mixes gas is
released--in both cases creating porosity in the carrier polymer,
and weakening it, allowing the physical form of the dressing filler
to change. The time period over which the coatings described herein
may release will vary depending on the desired treatment regimen.
In one embodiment, the coating may be configured to release as
quickly as within a few hours (e.g. 4 hours) or as long as a day or
more.
[0056] The coatings may be positioned on the exterior surfaces of
the dressing filler 1106 or alternatively may be used to coat both
exterior surfaces and the inner passages of the dressing filler
1106. In one embodiment, it may be desirable to uniformly coat the
dressing filler 1106 both externally and internally. Delivery of
the coating to the dressing filler 1106 may be accomplished by
dipping the dressing filler 1106 within the coating, or by
spraying, brushing, rolling, or otherwise applying the coating. In
one embodiment, the coating may be applied to a unitary dressing
filler 1106 that includes regions that have been compressed.
Alternatively, the coating may be applied to separate pieces of
compressed material that is then assembled to build the dressing
filler 1106. The attachment of multiple pieces to build the
dressing filler 1106 may be accomplished by bonding, mechanical
fastening, welding, or any other attachment means.
[0057] Referring to FIG. 12, as the coating is removed, the
compressed region is released and moves toward a relaxed state as
shown in FIG. 12. In the relaxed state, assuming the same type of
dressing filler is used in the compressed and the rest of the
dressing filler 1106, the density of openings and cell struts per
unit volume in the compressed regions will be approximately equal
to the density of openings and cell struts per unit volume in the
remainder of the dressing filler 1106. The height of the compressed
region 1130 typically increases as the compressed region 1130 moves
to the relaxed state.
[0058] Unlike dressing filler 106 in which there may be zero net
volume gain, the presence of the compressed region 1130 with no
expanded region in the dressing filler 1106 results in a positive
net volume gain when the compressed region 1130 moves to the
relaxed state. When the dressing filler 1106 is sealed beneath a
cover similar to cover 110 during tissue treatment, the change in
height of the compressed region, and thus the increase in volume of
the dressing filler 1106, results in an increase in the force
applied to the tissue site. This increase in force could be used to
ensure patient comfort by gradually increasing the force applied to
the tissue site as treatment begins. Alternatively, the increase in
force may allow a wider range of treatment regimens that promote
new tissue growth.
[0059] As an alternative to the coating, a removable sheath or
other covering may be placed around the dressing filler 1106 when
the compressed region has been charged to its compressed state. The
sheath may be a dissolvable or bioabsorbable substance such as a
woven or non-woven fabric, polyvinyl pyrrolidone, carboxy methyl
cellulose (CMC) and its salts and esters, alginates, gums such as
guar and xanthan, polyvinyl alcohol, polycaprolactam, poly lactic
acid and their copolymers or blends, or other polymers or
materials. In one embodiment, if a sheath or other covering is
used, the sheath may surround the dressing filler 1106 completely,
or may partially surround a portion of the dressing filler 1106. If
a dissolvable or bioabsorbable sheath is employed, the particular
material used and its thickness may be chosen to provide release
based on a desired time period. In another embodiment, the sheath
may instead be manually removed from the dressing filler 1106 by a
care giver or the patient when the change in treatment force is
desired.
[0060] Each of the dressing fillers 106, 406, 606, 906, 1106
described herein may be used with the reduced pressure treatment
system 100 of FIG. 1 or similar reduced pressure treatment systems
to encourage new tissue growth at a tissue site. During reduced
pressure treatment, as reduced pressure is applied to the sealed
space beneath the cover, the cover presses on the dressing filler,
thereby urging the dressing filler toward the tissue site. Some of
the structural components (e.g. struts 126 or nodes 412) of the
dressing filler contact the tissue site, and these structural
components provide point loads to the tissue site, thereby creating
a particular distribution of microstrain across the tissue site.
When the coating associated with the dressing filler is removed,
the various regions of the dressing filler that have been expanded
or compressed change state, which prompts movement of the dressing
filler and the associated structural components. In the case of
dressing fillers 106, 406, 606, and 906, this movement causes a
spatial redistribution of the point loads applied by the structural
components to the tissue site. This in turn creates a different
microstrain profile (i.e. the distribution of microstrain) at the
tissue site and helps prevent adhesion of new tissue growth to the
dressing filler. In the case of dressing fillers 906, 1106, the
movement of the dressing filler is capable of changing the
magnitude of the point loads applied to the tissue site. This also
creates a different microstrain profile which is beneficial to
wound healing.
[0061] The systems and methods described herein allow modification
of the microstrain experienced by a tissue site without changing
the dressing at the tissue site. In some cases, the microstrain
modification involves simply a redistribution of the microstrain
profile, while in other cases, the amplitude of the microstrain may
be increased or decreased. The dressings described herein each
incorporate nodes, struts, or other strain-inducing structures that
include at least one compressed region that is selectively held in
a compressed state or expanded region that is selectively held in
an expanded state. When released, the compressed or expanded
regions move to a relaxed state, which changes the distribution or
amount of microstrain applied to the tissue site. Each of the
dressings described herein is therefore believed to improve the
treatment of a tissue site using reduced pressure tissue treatment,
since changing the microstrain profile during reduced pressure
treatment will result in more even formation of granulation tissue
and will prevent adhesion of new tissue to the dressing.
[0062] While many of the systems described herein have been
illustrated in use with tissue sites or wounds that are at or near
the epidermis of a patient, the systems and methods may similarly
be used to treat subcutaneous tissue sites, tunnel wounds, or other
undermined areas of tissue.
[0063] While a number of discrete embodiments have been described,
aspects of each embodiment may not be specific to only that
embodiment and it is specifically contemplated that features of
embodiments may be combined with features of other embodiments.
While the subject matter of this specification is shown in only a
few of its forms, it is susceptible to various changes and
modifications without departing from the scope thereof.
[0064] Variations on the embodiments described herein comprising
both a compressed and expanded region may be provided utilizing
only an expanded or only a compressed region. For example, the
embodiment of FIG. 1 may be modified to utilize only vertical
compressed or expanded regions, but not regions of both types.
[0065] Where reference is made to a dimension, part, or region
being horizontal this is with reference to a plane substantially
parallel with the wound-facing surface of the dressing. Similarly,
vertical is referenced to this plane and so describes a plane
running substantially perpendicular to the wound-facing surface.
Where reference is made to one part being `above` or `below`
another part, this is made with reference to the wound-facing
surface being the `bottom` of the dressing.
[0066] The coatings securing the compressed and expanded regions
may be different such that the first and second coatings may be
removed at a different time. For example, the coatings may be of
different materials, or configured to dissolve over differing
periods of time.
* * * * *