U.S. patent application number 17/375731 was filed with the patent office on 2021-11-25 for multi-layer wound filler for extended wear time.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Timothy Mark ROBINSON.
Application Number | 20210361852 17/375731 |
Document ID | / |
Family ID | 1000005710786 |
Filed Date | 2021-11-25 |
United States Patent
Application |
20210361852 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
November 25, 2021 |
Multi-Layer Wound Filler For Extended Wear Time
Abstract
A dressing or wound filler comprising a laminate structure of
film materials. In one example embodiment, a dressing may include a
first layer comprising a first film, a second layer adjacent to the
first layer and comprising a second film, and a third layer
comprising a material having closed cells. The first layer may
further include a plurality of fluid restrictions. The second layer
may include blisters and apertures to allow fluid transfer through
the second film. The third layer may include closed cells and
apertures between the closed cells to allow fluid transfer through
the third layer. The dressing may further include a fourth layer
adjacent to the third layer opposite the second layer, which may
include a fourth film having blisters and apertures. The dressing
may also include a fifth layer, which may be adjacent to the fourth
layer opposite the third layer. The fifth layer may include a film
and a second plurality of fluid restrictions.
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: |
1000005710786 |
Appl. No.: |
17/375731 |
Filed: |
July 14, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16000215 |
Jun 5, 2018 |
11141524 |
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17375731 |
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62592950 |
Nov 30, 2017 |
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62576498 |
Oct 24, 2017 |
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62565754 |
Sep 29, 2017 |
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62516540 |
Jun 7, 2017 |
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62516566 |
Jun 7, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/90 20210501; A61F
13/00068 20130101; A61M 2205/3317 20130101; A61M 2205/3331
20130101; A61F 2013/00357 20130101; A61F 2013/00319 20130101; A61M
2205/3344 20130101; A61M 2205/3337 20130101; A61F 13/0216 20130101;
A61M 1/0058 20130101; A61F 13/0206 20130101; A61M 2210/1021
20130101; A61F 13/00063 20130101; A61M 1/85 20210501; A61M
2205/0216 20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61F 13/02 20060101 A61F013/02; A61F 13/00 20060101
A61F013/00 |
Claims
1-34. (canceled)
35. A wound filler for use with negative-pressure treatment, the
wound filler comprising: a manifold layer comprising a first layer
having closed cells and apertures configured to manifold fluid
through the first layer; and a second layer and a third layer
laminated to the manifold layer, the second layer and the third
layer each comprising a film of a hydrophobic material and
perforations or fenestrations configured to transfer fluid through
the film.
36. The wound filler of claim 35, wherein the manifold layer
further comprises a fourth layer having blisters and apertures
configured to manifold fluid through the fourth layer.
37. The wound filler of claim 35, wherein the closed cells contain
fluid.
38. The wound filler of claim 35, wherein the film of the second
layer and the third layer is a polyethylene film.
39. The wound filler of claim 35, wherein the perforations or
fenestrations comprise linear perforations, each of the linear
perforations having a length not greater than 4 millimeters.
40. The wound filler of claim 35, wherein: the first layer
comprises two films bonded together; and the closed cells are
defined by the two films.
41. The wound filler of claim 35, wherein the manifold layer
further comprises: a fourth layer having blisters and apertures
configured to manifold fluid through the manifold layer; and a
fifth layer having blisters and apertures configured to manifold
fluid through the manifold layer.
42. The wound filler of claim 35, wherein the closed cells have a
diameter of between 1.5 mm and 3 mm.
43. A system for treating a tissue site, comprising: a wound
filler, comprising: a first layer comprising a first film of
non-porous material and a plurality of fluid restrictions; a second
layer adjacent to the first layer, the second layer comprising a
second film of non-porous material having blisters and first
apertures; and a third layer comprising a non-porous material
having closed cells and second apertures between the closed cells;
a fourth layer coupled to the first layer opposite the second layer
and comprising a polymer drape; and an interface adapted to be
coupled to the fourth layer.
44. The system of claim 43, further comprising a negative-pressure
source adapted to be fluidly connected to the wound filler through
the interface.
45. A wound filler, comprising: a first layer comprising a first
film of non-porous material and a first plurality of fluid
restrictions; a second layer adjacent to the first layer, the
second layer comprising a second film of non-porous material having
blisters and first apertures; a third layer comprising a first
plurality of closed cells and second apertures between the closed
cells; a fourth layer comprising a second plurality of closed cells
and third apertures between the closed cells; a fifth layer
adjacent to the fourth layer opposite the third layer, the fifth
layer comprising a third film of non-porous material having
blisters and fourth apertures; and a sixth layer adjacent the fifth
layer comprising a fourth film of non-porous material and a second
plurality of fluid restrictions.
46. The wound filler of claim 45, further comprising a seventh
layer positioned between the third layer and the fourth layer, the
seventh layer comprising a third plurality of closed cells.
47. A dressing for treating a tissue site, comprising: a first
layer comprising a first film of non-porous material and a first
plurality of fluid restrictions; and a second layer adjacent to the
first layer, the second layer comprising a second film of
non-porous material having blisters and first apertures to allow
fluid transfer through the second film.
48. A manifold for use with negative-pressure treatment,
comprising: a first film of non-porous material comprising a
plurality of fluid restrictions; a second film of non-porous
material comprising first apertures; and a plurality of closed
cells formed between the first film and the second film.
49. The manifold of claim 48, wherein the plurality of fluid
restrictions and the first apertures are between the closed cells
to allow fluid transfer through the manifold.
50. The manifold of claim 48, further comprising a third film of
non-porous material having blisters and second apertures to allow
fluid transfer through the third film, wherein the second film is
positioned between the first film and the third film.
51. The manifold of claim 48, wherein the first film is
hydrophobic.
52. The manifold of claim 48, wherein the first film is a
polyethylene film.
53. The manifold of claim 48, wherein the fluid restrictions
comprise or consist essentially of elastomeric valves that are
normally closed and open in response to a pressure gradient across
the first film.
54. The manifold of claim 48, wherein the fluid restrictions
comprise linear fenestrations, each of the linear fenestrations
having a length not greater than 4 millimeters.
55. (canceled)
Description
RELATED APPLICATION
[0001] This application is a divisional of U.S. patent application
Ser. No. 16/000,215, filed Jun. 5, 2018, which claims benefit,
under 35 U.S.C. .sctn. 119(e), of the filing of U.S. Provisional
Patent Application Ser. No. 62/592,950, entitled "MULTI-LAYER WOUND
FILLER FOR EXTENDED WEAR TIME," filed Nov. 30, 2017; U.S.
Provisional Patent Application Ser. No. 62/576,498, entitled
"SYSTEMS, APPARATUSES, AND METHODS FOR NEGATIVE-PRESSURE TREATMENT
WITH REDUCED TISSUE IN-GROWTH," filed Oct. 24, 2017; U.S.
Provisional Patent Application Ser. No. 62/565,754, entitled
"COMPOSITE DRESSINGS FOR IMPROVED GRANULATION AND REDUCED
MACERATION WITH NEGATIVE-PRESSURE TREATMENT," filed Sep. 29, 2017;
U.S. Provisional Patent Application Ser. No. 62/516,540, entitled
"TISSUE CONTACT INTERFACE," filed Jun. 7, 2017; U.S. Provisional
Patent Application Ser. No. 62/516,550, entitled "COMPOSITE
DRESSINGS FOR IMPROVED GRANULATION AND REDUCED MACERATION WITH
NEGATIVE-PRESSURE TREATMENT" filed Jun. 7, 2017; and U.S.
Provisional Patent Application Ser. No. 62/516,566, entitled
"COMPOSITE DRESSINGS FOR IMPROVED GRANULATION AND REDUCED
MACERATION WITH NEGATIVE-PRESSURE TREATMENT" filed Jun. 7, 2017,
each of which is incorporated herein by reference for all
purposes.
TECHNICAL FIELD
[0002] The invention set forth in the appended claims relates
generally to tissue treatment systems and more particularly, but
without limitation, to dressings for tissue treatment and methods
of using the dressings for tissue treatment.
BACKGROUND
[0003] Clinical studies and practice have shown that reducing
pressure in proximity to a tissue site can augment and accelerate
growth of new tissue at the tissue site. The applications of this
phenomenon are numerous, but it has proven particularly
advantageous for treating wounds. Regardless of the etiology of a
wound, whether trauma, surgery, or another cause, proper care of
the wound is important to the outcome. Treatment of wounds or other
tissue with reduced pressure may be commonly referred to as
"negative-pressure therapy," but is also known by other names,
including "negative-pressure wound therapy," "reduced-pressure
therapy," "vacuum therapy," "vacuum-assisted closure," and "topical
negative-pressure," for example. Negative-pressure therapy may
provide a number of benefits, including migration of epithelial and
subcutaneous tissues, improved blood flow, and micro-deformation of
tissue at a wound site. Together, these benefits can increase
development of granulation tissue and reduce healing times.
[0004] There is also widespread acceptance that cleansing a tissue
site can be highly beneficial for new tissue growth. For example, a
wound can be washed out with a stream of liquid solution, or a
cavity can be washed out using a liquid solution for therapeutic
purposes. These practices are commonly referred to as "irrigation"
and "lavage" respectively. "Instillation" is another practice that
generally refers to a process of slowly introducing fluid to a
tissue site and leaving the fluid for a prescribed period of time
before removing the fluid. For example, instillation of topical
treatment solutions over a wound bed can be combined with
negative-pressure therapy to further promote wound healing by
loosening soluble contaminants in a wound bed and removing
infectious material. As a result, soluble bacterial burden can be
decreased, contaminants removed, and the wound cleansed.
[0005] While the clinical benefits of negative-pressure therapy and
instillation therapy are widely known, improvements to therapy
systems, components, and processes may benefit healthcare providers
and patients.
BRIEF SUMMARY
[0006] New and useful systems, apparatuses, and methods for
treating tissue in a negative-pressure therapy environment are set
forth in the appended claims. Illustrative embodiments are also
provided to enable a person skilled in the art to make and use the
claimed subject matter.
[0007] For example, in some embodiments, a dressing or wound filler
may comprise a laminate structure of film materials. Outer layers
may comprise perforated or fenestrated film configured to face a
tissue site. Examples of material suitable for outer layers include
polythene, polyurethane, and ethyl methyl acrylate (EMA). The outer
layers may have linear perforations or fenestrations formed over
the surface. The size and spacing of the perforations or
fenestrations may vary. In some examples, the length of the
perforations or fenestrations may be between 2 millimeters and 4
millimeters, spaced between 2 millimeters and 4 millimeters apart
along their length and from side to side. The width of perforations
may be between 0.4 millimeters and 1 millimeter in some examples.
Suitable perforations may be formed, for example, by laser,
ultrasonics, or other heat means. Intermediate spacing layers
between the outer layers can manifold fluid, provide a compressible
filler that can conform to spaces and curves, and can present a
barrier to tissue in-growth. The outer layers may be more
hydrophobic than the intermediate layers in some examples.
[0008] More generally, in some embodiments, a dressing may include
a first layer comprising a first film of non-porous material, a
second layer adjacent to the first layer and comprising a second
film of non-porous material, and a third layer comprising a
non-porous material having closed cells. The first layer may
further include a plurality of fluid restrictions. The second film
of non-porous material of the second layer may include blisters and
first apertures to allow fluid transfer through the second film.
The non-porous material of the third layer may include closed cells
and second apertures between the closed cells to allow fluid
transfer through the third layer. The dressing may additionally
include a fourth layer adjacent to the third layer opposite the
second layer and a fifth layer adjacent to the fourth layer
opposite the third layer. The fourth layer may include a third film
of non-porous material having blisters and fourth apertures for
allowing fluid transfer through the fourth layer. The fifth layer
may include a fourth film of non-porous material and a second
plurality of fluid restrictions.
[0009] In other example embodiments, a wound filler for use with
negative-pressure treatment may include a manifold layer comprising
a first layer, a second layer, and a third layer, where the second
layer and the third layer are laminated to the manifold layer. The
first layer of the manifold layer may include closed cells and
apertures configured to manifold fluid through the manifold layer.
The second layer and the third layer may each include a film of a
hydrophobic material and perforations or fenestrations configured
to transfer fluid through the film. In some embodiments, the
manifold layer may further include a fourth layer having blisters
and apertures configured to manifold fluid through the manifold
layer.
[0010] In still further example embodiments, a system for treating
a tissue site may include a wound filler having a first layer,
second layer, and third layer, and the system may additionally
include a fourth layer and an interface. The first layer of the
wound filler may comprise a first film of non-porous material and a
plurality of fluid restrictions. The second layer may be adjacent
to the first layer and may comprise a second film of non-porous
material having blisters and first apertures. The third layer may
comprise a non-porous material having closed cells and second
apertures between the closed cells. The fourth layer may be coupled
to the first layer opposite the second layer and may comprise a
polymer drape. The interface may be adapted to be coupled to the
fourth layer. The system may further include a negative-pressure
source adapted to be fluidly connected to the wound filler through
the interface.
[0011] In yet further example embodiments, a wound filler may
include a first layer, a second layer, a third layer, a fourth
layer, a fifth layer, and a sixth layer. The first layer may
comprise a first film of non-porous material and a first plurality
of fluid restrictions. The second layer may be adjacent to the
first layer and may comprise a second film of non-porous material
having blisters and first apertures. The third layer may comprise a
first plurality of closed cells and second apertures between the
closed cells. The fourth layer may comprise a second plurality of
closed cells and third apertures between the closed cells. The
fifth layer may be adjacent to the fourth layer opposite the third
layer and may comprise a third film of non-porous material having
blisters and fourth apertures. The sixth layer may be adjacent the
fifth layer and may comprise a fourth film of non-porous material
and a second plurality of fluid restrictions. Additionally, the
wound filler may include a seventh layer positioned between the
third layer and the fourth layer, which may comprise a third
plurality of closed cells.
[0012] In other example embodiments, a dressing may include a first
layer comprising a first film of non-porous material and a second
layer adjacent to the first layer, the second layer comprising a
second film of non-porous material. The first layer may comprise a
first plurality of fluid restrictions. The second layer may
comprise blisters and first apertures to allow fluid transfer
through the second film.
[0013] In yet another example embodiment, a manifold for use with
negative-pressure treatment may include a first film of non-porous
material, a second film of non-porous material, and a plurality of
closed cells formed between the first film and the second film. The
first film may include a plurality of fluid restrictions. The
second film may comprise first apertures.
[0014] Objectives, advantages, and a preferred mode of making and
using the claimed subject matter may be understood best by
reference to the accompanying drawings in conjunction with the
following detailed description of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a functional block diagram of an example
embodiment of a therapy system that can provide tissue treatment in
accordance with this specification;
[0016] FIG. 2 is an assembly view of an example of a dressing,
illustrating additional details that may be associated with some
example embodiments of the therapy system of FIG. 1;
[0017] FIG. 3 is a schematic view of an example configuration of
fluid restrictions in a layer that may be associated with some
embodiments of the dressing of FIG. 2;
[0018] FIG. 4 is a top view of an example configuration of blisters
in another layer that may be associated with some embodiments of
the dressing of FIG. 2;
[0019] FIG. 5 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
4;
[0020] FIG. 6 is a top view of an example configuration of closed
cells in another layer that may be associated with some embodiments
of the dressing of FIG. 2;
[0021] FIG. 7 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
6;
[0022] FIG. 8 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
6;
[0023] FIG. 9 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
6;
[0024] FIG. 10 is a top view of another example configuration of
closed cells in a layer that may be associated with some
embodiments of the dressing of FIG. 2;
[0025] FIG. 11 is a top view of another example configuration of
closed cells in a layer that may be associated with some
embodiments of the dressing of FIG. 2;
[0026] FIG. 12 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
11;
[0027] FIG. 13 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
11;
[0028] FIG. 14 is a section view illustrating additional details
that may be associated with some embodiments of the layer of FIG.
11;
[0029] FIG. 15 is a top view of another example configuration of
closed cells in a layer that may be associated with some
embodiments of the dressing of FIG. 2;
[0030] FIG. 16 is a top view of another example configuration of
closed cells in a layer that may be associated with some
embodiments of the dressing of FIG. 2;
[0031] FIG. 17 is an assembly view of an example of a tissue
interface, illustrating additional details that may be associated
with some example embodiments of the therapy system of FIG. 1;
[0032] FIG. 18 is an assembly view of another example of a tissue
interface, illustrating additional details that may be associated
with some example embodiments of the therapy system of FIG. 1;
[0033] FIG. 19 is an assembly view of another example of a tissue
interface, illustrating additional details that may be associated
with some example embodiments of the therapy system of FIG. 1;
[0034] FIG. 20 is an assembly view of another example of a tissue
interface, illustrating additional details that may be associated
with some example embodiments of the therapy system of FIG. 1;
and
[0035] FIG. 21 is an assembly view of another example of a tissue
interface, illustrating additional details that may be associated
with some example embodiments of the therapy system of FIG. 1.
DESCRIPTION OF EXAMPLE EMBODIMENTS
[0036] The following description of example embodiments provides
information that enables a person skilled in the art to make and
use the subject matter set forth in the appended claims, but may
omit certain details already well-known in the art. The following
detailed description is, therefore, to be taken as illustrative and
not limiting.
[0037] The example embodiments may also be described herein with
reference to spatial relationships between various elements or to
the spatial orientation of various elements depicted in the
attached drawings. In general, such relationships or orientation
assume a frame of reference consistent with or relative to a
patient in a position to receive treatment. However, as should be
recognized by those skilled in the art, this frame of reference is
merely a descriptive expedient rather than a strict
prescription.
[0038] FIG. 1 is a simplified functional block diagram of an
example embodiment of a therapy system 100 that can provide
negative-pressure therapy with instillation of topical treatment
solutions to a tissue site in accordance with this
specification.
[0039] The term "tissue site" in this context broadly refers to a
wound, defect, or other treatment target located on or within
tissue, including but not limited to, a surface wound, bone tissue,
adipose tissue, muscle tissue, neural tissue, dermal tissue,
vascular tissue, connective tissue, cartilage, tendons, or
ligaments. 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 may be desirable to add or promote the
growth of additional tissue. For example, negative pressure may be
applied to a tissue site to grow additional tissue that may be
harvested and transplanted. A surface wound, as used herein, is a
wound on the surface of a body that is exposed to the outer surface
of the body, such an injury or damage to the epidermis, dermis,
and/or subcutaneous layers. Surface wounds may include ulcers or
closed incisions, for example. A surface wound, as used herein,
does not include wounds within an intra-abdominal cavity. A wound
may include chronic, acute, traumatic, subacute, and dehisced
wounds, partial-thickness burns, ulcers (such as diabetic,
pressure, or venous insufficiency ulcers), flaps, and grafts, for
example.
[0040] The therapy system 100 may include a source or supply of
negative pressure, such as a negative-pressure source 102, a
dressing 104, a fluid container, such as a container 106, and a
regulator or controller, such as a controller 108, for example.
Additionally, the therapy system 100 may include sensors to measure
operating parameters and provide feedback signals to the controller
108 indicative of the operating parameters. As illustrated in FIG.
1, for example, the therapy system 100 may include a pressure
sensor 110, an electric sensor 112, or both, coupled to the
controller 108. As illustrated in the example of FIG. 1, the
dressing 104 may comprise or consist essentially of one or more
dressing layers, such as a tissue interface 114, a cover 116, or
both in some embodiments.
[0041] The therapy system 100 may also include a source of
instillation solution, such as saline, for example. For example, a
solution source 118 may be fluidly coupled to the dressing 104, as
illustrated in the example embodiment of FIG. 1. The solution
source 118 may be fluidly coupled to a positive-pressure source
such as the positive-pressure source 120, a negative-pressure
source such as the negative-pressure source 102, or both in some
embodiments. A regulator, such as an instillation regulator 122,
may also be fluidly coupled to the solution source 118 and the
dressing 104 to ensure proper dosage of instillation solution to a
tissue site. For example, the instillation regulator 122 may
comprise a piston that can be pneumatically actuated by the
negative-pressure source 102 to draw instillation solution from the
solution source 118 during a negative-pressure interval and to
instill the solution to a dressing during a venting interval.
Additionally or alternatively, the controller 108 may be coupled to
the negative-pressure source 102, the positive-pressure source 120,
or both, to control dosage of instillation solution to a tissue
site. In some embodiments, the instillation regulator 122 may also
be fluidly coupled to the negative-pressure source 102 through the
dressing 104, as illustrated in the example of FIG. 1.
[0042] Some components of the therapy system 100 may be housed
within or used in conjunction with other components, such as
sensors, processing units, alarm indicators, memory, databases,
software, display devices, or user interfaces that further
facilitate therapy. For example, in some embodiments, the
negative-pressure source 102 may be combined with the solution
source 118, the controller 108 and other components into a therapy
unit.
[0043] In general, components of the therapy system 100 may be
coupled directly or indirectly. For example, the negative-pressure
source 102 may be directly coupled to the container 106, and may be
indirectly coupled to the dressing 104 through the container 106.
Coupling may include fluid, mechanical, thermal, electrical, or
chemical coupling (such as a chemical bond), or some combination of
coupling in some contexts. For example, the negative-pressure
source 102 may be electrically coupled to the controller 108. The
negative-pressure source may be fluidly coupled to one or more
distribution components, which provide a fluid path to a tissue
site. In some embodiments, components may also be coupled by virtue
of physical proximity, being integral to a single structure, or
being formed from the same piece of material. For example, the
tissue interface 114 and the cover 116 may be discrete layers
disposed adjacent to each other, and may be joined together in some
embodiments.
[0044] A distribution component is preferably detachable, and may
be disposable, reusable, or recyclable. The dressing 104 and the
container 106 are illustrative of distribution components. A fluid
conductor is another illustrative example of a distribution
component. A "fluid conductor," in this context, broadly includes a
tube, pipe, hose, conduit, or other structure with one or more
lumina or open pathways adapted to convey a fluid between two ends.
Typically, a tube is an elongated, cylindrical structure with some
flexibility, but the geometry and rigidity may vary. Moreover, some
fluid conductors may be molded into or otherwise integrally
combined with other components. Distribution components may also
include or comprise interfaces or fluid ports to facilitate
coupling and de-coupling other components, including sensors and
data communication devices. In some embodiments, for example, a
dressing interface may facilitate coupling a fluid conductor to the
dressing 104. For example, such a dressing interface may be a
SENSAT.R.A.C..TM. Pad available from KCI of San Antonio, Tex.
[0045] A negative-pressure supply, such as the negative-pressure
source 102, may be a reservoir of air at a negative pressure, or
may be a manual or electrically-powered device, such as a vacuum
pump, a suction pump, a wall suction port available at many
healthcare facilities, or a micro-pump, for example. "Negative
pressure" generally refers to a pressure less than a local ambient
pressure, such as the ambient pressure in a local environment
external to a sealed therapeutic environment. In many cases, the
local ambient pressure may also be the atmospheric pressure at
which a tissue site is located. Alternatively, the pressure may be
less than a hydrostatic pressure associated with tissue at the
tissue site. Unless otherwise indicated, values of pressure stated
herein are gauge pressures. References to increases in negative
pressure typically refer to a decrease in absolute pressure, while
decreases in negative pressure typically refer to an increase in
absolute pressure. While the amount and nature of negative pressure
applied to a tissue site may vary according to therapeutic
requirements, the pressure is generally a low vacuum, also commonly
referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500
mm Hg (-66.7 kPa). Common therapeutic ranges are between -50 mm Hg
(-9.9 kPa) and -300 mm Hg (-39.9 kPa).
[0046] The container 106 is representative of a container,
canister, pouch, or other storage component, which can be used to
manage exudates and other fluids withdrawn from a tissue site. In
many environments, a rigid container may be preferred or required
for collecting, storing, and disposing of fluids. In other
environments, fluids may be properly disposed of without rigid
container storage, and a re-usable container could reduce waste and
costs associated with negative-pressure therapy.
[0047] A controller, such as the controller 108, may be a
microprocessor or computer programmed to operate one or more
components of the therapy system 100, such as the negative-pressure
source 102. In some embodiments, for example, the controller 108
may be a microcontroller, which generally comprises an integrated
circuit containing a processor core and a memory programmed to
directly or indirectly control one or more operating parameters of
the therapy system 100. Operating parameters may include the power
applied to the negative-pressure source 102, the pressure generated
by the negative-pressure source 102, or the pressure distributed to
the tissue interface 114, for example. The controller 108 is also
preferably configured to receive one or more input signals, such as
a feedback signal, and programmed to modify one or more operating
parameters based on the input signals.
[0048] Sensors, such as the pressure sensor 110 or the electric
sensor 112, are generally known in the art as any apparatus
operable to detect or measure a physical phenomenon or property,
and generally provide a signal indicative of the phenomenon or
property that is detected or measured. For example, the pressure
sensor 110 and the electric sensor 112 may be configured to measure
one or more operating parameters of the therapy system 100. In some
embodiments, the pressure sensor 110 may be a transducer configured
to measure pressure in a pneumatic pathway and convert the
measurement to a signal indicative of the pressure measured. In
some embodiments, for example, the pressure sensor 110 may be a
piezo-resistive strain gauge. The electric sensor 112 may
optionally measure operating parameters of the negative-pressure
source 102, such as the voltage or current, in some embodiments.
Preferably, the signals from the pressure sensor 110 and the
electric sensor 112 are suitable as an input signal to the
controller 108, but some signal conditioning may be appropriate in
some embodiments. For example, the signal may need to be filtered
or amplified before it can be processed by the controller 108.
Typically, the signal is an electrical signal, but may be
represented in other forms, such as an optical signal.
[0049] The tissue interface 114 can be generally adapted to
partially or fully contact a tissue site. If the tissue site is a
wound, for example, the tissue interface 114 may partially or
completely fill the wound, or may be placed over the wound. The
tissue interface 114 may take many forms and may have many sizes,
shapes, or thicknesses depending on a variety of factors, such as
the type of treatment being implemented or the nature and size of a
tissue site. For example, the size and shape of the tissue
interface 114 may be adapted to the contours of deep and irregular
shaped tissue sites. The tissue interface 114 may take many forms
and have more than one layer in some embodiments. Moreover, one or
more surfaces of the tissue interface 114 may have projections or
an uneven, coarse, or jagged profile that can induce strains and
stresses on a tissue site, which can promote granulation at the
tissue site.
[0050] Additionally, the tissue interface 114 may comprise,
consist, or function as a manifold. In this context, a "manifold"
generally includes any substance or structure providing a plurality
of pathways adapted to collect or distribute fluid, which may
involve moving fluid across a tissue site under pressure. For
example, a manifold may be adapted to receive negative pressure
from a source and distribute negative pressure through multiple
apertures across a tissue site, which may have the effect of
collecting fluid from across a tissue site and drawing the fluid
toward the source of negative pressure. Furthermore, in some
embodiments, the fluid path may be reversed or a secondary fluid
path may be provided to facilitate delivering fluid across a tissue
site. In some embodiments, a manifold may additionally or
alternatively comprise projections that form interconnected fluid
pathways. For example, a manifold may be molded to provide surface
projections that define interconnected fluid pathways.
[0051] In some embodiments, the cover 116 may provide a bacterial
barrier and protection from physical trauma. The cover 116 may also
be constructed from a material that can reduce evaporative losses
and provide a fluid seal between two components or two
environments, such as between a therapeutic environment and a local
external environment. The cover 116 may be, for example, an
elastomeric film or membrane that can provide a seal adequate to
maintain a negative pressure at a tissue site for a given
negative-pressure source. The cover 116 may have a high
moisture-vapor transmission rate (MVTR) in some applications. For
example, the MVTR may be at least 250 grams per square meter per
twenty-four hours in some embodiments, measured using an upright
cup technique according to ASTM E96/E96M Upright Cup Method at
38.degree. C. and 10% relative humidity (RH). In some embodiments,
an MVTR up to 5,000 grams per square meter per twenty-four hours
may provide may provide effective breathability and mechanical
properties. In some example embodiments, the cover 116 may be a
polymer drape, such as a polyurethane film, that is permeable to
water vapor but impermeable to liquid. Such drapes typically have a
thickness in the range of 25-50 microns. For permeable materials,
the permeability generally should be low enough that a desired
negative pressure may be maintained.
[0052] An attachment device may be used to attach the cover 116 to
an attachment surface, such as undamaged epidermis, a gasket, or
another cover. The attachment device may take many forms. For
example, an attachment device may be a medically-acceptable,
pressure-sensitive adhesive configured to bond the cover 116 to
epidermis around a tissue site. In some embodiments, for example,
some or all of the cover 116 may be coated with an adhesive, such
as an acrylic adhesive, which may have a coating weight between
25-65 grams per square meter (g.s.m.). Thicker adhesives, or
combinations of adhesives, may be applied in some embodiments to
improve the seal and reduce leaks. Other example embodiments of an
attachment device may include a double-sided tape, paste,
hydrocolloid, hydrogel, silicone gel, or organogel.
[0053] The solution source 118 may also be representative of a
container, canister, pouch, bag, or other storage component, which
can provide a solution for instillation therapy. Compositions of
solutions may vary according to a prescribed therapy, but examples
of solutions that may be suitable for some prescriptions include
hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based
solutions, biguanides, cationic solutions, and isotonic
solutions.
[0054] The fluid mechanics of using a negative-pressure source to
reduce pressure in another component or location, such as within a
sealed therapeutic environment, can be mathematically complex.
However, the basic principles of fluid mechanics applicable to
negative-pressure therapy are generally well known to those skilled
in the art, and the process of reducing pressure may be described
illustratively herein as "delivering," "distributing," or
"generating" negative pressure, for example.
[0055] In general, exudates and other fluids flow toward lower
pressure along a fluid path. Thus, the term "downstream" typically
implies something in a fluid path relatively closer to a source of
negative pressure or further away from a source of positive
pressure. Conversely, the term "upstream" implies something
relatively further away from a source of negative pressure or
closer to a source of positive pressure. Similarly, it may be
convenient to describe certain features in terms of fluid "inlet"
or "outlet" in such a frame of reference. This orientation is
generally presumed for purposes of describing various features and
components herein. However, the fluid path may also be reversed in
some applications (such as by substituting a positive-pressure
source for a negative-pressure source) and this descriptive
convention should not be construed as a limiting convention.
[0056] FIG. 2 is an assembly view of an example of the dressing 104
of FIG. 1, illustrating additional details that may be associated
with some embodiments in which the tissue interface 114 comprises
more than one layer. In the example of FIG. 2, the tissue interface
114 comprises a first layer 210, a second layer 212, and a third
layer 214. In some embodiments, the third layer 214 may be disposed
between portions of the second layer 212 and may also be disposed
between portions of the first layer 210. For example, the second
layer 212 may be disposed adjacent to two sides of the third layer
214. In some embodiments, for example, the second layer 212 may be
laminated or otherwise mechanically bonded to two sides of the
third layer 214. Additionally, the first layer 210 may be disposed
adjacent to two sides of the second layer 212, and in some
embodiments, the first layer 210 may be laminated or otherwise
bonded to two sides of the second layer 212. The first layer 210,
the second layer 212, and the third layer 214 may be stacked so
that the second layer 212 is adjacent to and in contact with the
first layer 210 and the third layer 214. The second layer 212 may
also be bonded to the first layer 210, the third layer 214, or both
in some embodiments. In some embodiments, the first layer 210 may
form a sleeve or envelope around the second layer 212, the third
layer 214, or both.
[0057] The first layer 210 may comprise or consist essentially of a
means for controlling or managing fluid flow. In some embodiments,
the first layer 210 may comprise or consist essentially of a
liquid-impermeable, elastomeric material. For example, the first
layer 210 may comprise or consist essentially of a non-porous
polymer film. The first layer 210 may also have a smooth or matte
surface texture in some embodiments. A glossy or shiny finish
better or equal to a grade B3 according to the SPI (Society of the
Plastics Industry) standards may be particularly advantageous for
some applications. In some embodiments, variations in surface
height may be limited to acceptable tolerances. For example, the
surface of the second layer may have a substantially flat surface,
with height variations limited to 0.2 millimeters over a
centimeter.
[0058] In some embodiments, the first layer 210 may be hydrophobic.
The hydrophobicity of the first layer 210 may vary, but may have a
contact angle with water of at least ninety degrees in some
embodiments. In some embodiments, the first layer 210 may have a
contact angle with water of no more than 150 degrees. For example,
in some embodiments, the contact angle of the first layer 210 may
be in a range of at least 90 degrees to about 120 degrees, or in a
range of at least 120 degrees to 150 degrees. Water contact angles
can be measured using any standard apparatus. Although manual
goniometers can be used to visually approximate contact angles,
contact angle measuring instruments can often include an integrated
system involving a level stage, liquid dropper such as a syringe,
camera, and software designed to calculate contact angles more
accurately and precisely, among other things. Non-limiting examples
of such integrated systems may include the FT.ANG.125, FT.ANG.200,
FT.ANG.2000, and FT.ANG.4000 systems, all commercially available
from First Ten Angstroms, Inc., of Portsmouth, Va., and the DTA25,
DTA30, and DTA100 systems, all commercially available from Kruss
GmbH of Hamburg, Germany. Unless otherwise specified, water contact
angles herein are measured using deionized and distilled water on a
level sample surface for a sessile drop added from a height of no
more than 5 cm in air at 20-25.degree. C. and 20-50% relative
humidity. Contact angles reported herein represent averages of 5-9
measured values, discarding both the highest and lowest measured
values. The hydrophobicity of the first layer 210 may be further
enhanced with a hydrophobic coating of other materials, such as
silicones and fluorocarbons, either as coated from a liquid or
plasma coated.
[0059] The first layer 210 may also be suitable for welding to
other layers, including the second layer 212. For example, the
first layer 210 may be adapted for welding to other film layers
using heat, radio frequency (RF) welding, or other methods to
generate heat such as ultrasonic welding. RF welding may be
particularly suitable for more polar materials, such as
polyurethane, polyamides, polyesters and acrylates. Sacrificial
polar interfaces may be used to facilitate RF welding of less polar
film materials such as polyethylene.
[0060] The area density of the first layer 210 may vary according
to a prescribed therapy or application. In some embodiments, an
area density of less than 40 grams per square meter may be
suitable, and an area density of about 20-30 grams per square meter
may be particularly advantageous for some applications.
[0061] In some embodiments, for example, the first layer 210 may
comprise or consist essentially of a hydrophobic polymer, such as a
polyethylene film. The simple and inert structure of polyethylene
can provide a surface that interacts little, if any, with
biological tissues and fluids, providing a surface that may
encourage the free flow of liquids and low adherence, which can be
particularly advantageous for many applications. Other suitable
polymeric films include polyurethanes, acrylics, polyolefin (such
as cyclic olefin copolymers), polyacetates, polyamides, polyesters,
copolyesters, PEBAX block copolymers, thermoplastic elastomers,
thermoplastic vulcanizates, polyethers, polyvinyl alcohols,
polypropylene, polymethylpentene, polycarbonate, styreneics,
silicones, fluoropolymers, and acetates. A thickness between 20
microns and 100 microns may be suitable for many applications.
Films may be clear, colored, or printed. More polar films suitable
for laminating to a polyethylene film include polyamide,
co-polyesters, ionomers, and acrylics. To aid in the bond between a
polyethylene and polar film, tie layers may be used, such as
ethylene vinyl acetate, or modified polyurethanes. An ethyl methyl
acrylate (EMA) film may also have suitable hydrophobic and welding
properties for some configurations.
[0062] As illustrated in the example of FIG. 2, the first layer 210
may have one or more fluid restrictions 220, which can be
distributed uniformly or randomly across the first layer 210. The
fluid restrictions 220 may be bi-directional and
pressure-responsive. For example, each of the fluid restrictions
220 generally may comprise or consist essentially of an elastic
passage that is normally unstrained to substantially reduce liquid
flow, and can expand or open in response to a pressure gradient. In
some embodiments, the fluid restrictions 220 may comprise or
consist essentially of perforations in the first layer 210.
Perforations may be formed by removing material from the first
layer 210. For example, perforations may be formed by cutting
through the first layer 210, which may also deform the edges of the
perforations in some embodiments. In the absence of a pressure
gradient across the perforations, the passages may be sufficiently
small to form a seal or fluid restriction, which can substantially
reduce or prevent liquid flow. Additionally or alternatively, one
or more of the fluid restrictions 220 may be an elastomeric valve
that is normally closed when unstrained to substantially prevent
liquid flow, and can open in response to a pressure gradient. A
fenestration in the first layer 210 may be a suitable valve for
some applications. Fenestrations may also be formed by removing
material from the first layer 210, but the amount of material
removed and the resulting dimensions of the fenestrations may be an
order of magnitude less than perforations, and may result in edges
that are not deformed. Additionally, in some embodiments,
perforations may be formed by mechanical slitting then controlled
uni- and/or bi-axial stretching of the film material of the first
layer 210.
[0063] For example, some embodiments of the fluid restrictions 220
may comprise or consist essentially of one or more slits, slots, or
combinations of slits and slots in the first layer 210. In some
examples, the fluid restrictions 220 may comprise or consist of
linear slots having a length less than 4 millimeters and a width
less than 1 millimeter. The length may be at least 2 millimeters,
and the width may be at least 0.4 millimeters in some embodiments.
A length of about 3 millimeters and a width of about 0.8
millimeters may be particularly suitable for many applications, and
a tolerance of about 0.1 millimeter may also be acceptable. Such
dimensions and tolerances may be achieved with a laser cutter,
ultrasonics, or other heat means, for example. The linear slits or
slots may be spaced apart by about 2 to 4 millimeters along their
length and from side-to-side. Slots of such configurations may
function as imperfect valves that substantially reduce liquid flow
in a normally closed or resting state. For example, such slots may
form a flow restriction without being completely closed or sealed.
The slots can expand or open wider in response to a pressure
gradient to allow increased liquid flow.
[0064] The second layer 212 generally comprises or consists
essentially of a manifold or a manifold layer, which provides a
means for collecting or distributing fluid across the tissue
interface 114 under pressure. For example, the second layer 212 may
be adapted to receive negative pressure from a source and
distribute negative pressure through multiple apertures across the
tissue interface 114, which may have the effect of collecting fluid
from across a tissue site and drawing the fluid toward the source.
In some embodiments, the fluid path may be reversed or a secondary
fluid path may be provided to facilitate delivering fluid, such as
from a source of instillation solution, across the tissue interface
114.
[0065] In some embodiments, the second layer 212 may comprise or
consist essentially of a film of fluid-impermeable material having
blisters 225. Polyurethane is an example of a suitable
fluid-impermeable material for some applications of the second
layer 212. In some embodiments, the blisters 225 may comprise a
plurality of raised formations that extend above or below a plane
of the second layer 212. Within each of the blisters 225 may be an
empty cavity which may be open to the surrounding environment. For
example, portions of a film of fluid-impermeable material that
forms the second layer 212 may be shaped or formed into the
blisters 225. In some embodiments, the blisters 225 may be in the
form of small vacuum-formed regions of the film of the second layer
212. In some embodiments, each individual blister of the blisters
225 may be dome-shaped or hemispherically-shaped. Additionally or
alternatively, the blisters 225 may be in the form of raised
formations having different shapes, such as generally conical,
cylindrical, tubular having a flattened or hemispherical end, or
geodesic. The second layer 212 may further include apertures 230 to
allow fluid transfer through the film. The blisters 225 may assist
with enabling the second layer 212 to function as the core
manifolding layer of the tissue interface 114.
[0066] The thickness of the second layer 212 may also vary
according to needs of a prescribed therapy. For example, the
thickness of the second layer 212 may be decreased to relieve
stress on other layers and to reduce tension on peripheral tissue.
The thickness of the second layer 212 can also affect the
conformability of the second layer 212. In some embodiments, the
second layer 212 may comprise a film having a thickness in a range
of about 20 to 500 micrometers with blisters 225 having a diameter
of between 0.5 mm and 2.0 mm. Depending on the particular
embodiment, the orientation of the second layer 212 may be reversed
so that the blisters 225 of the second layer 212 may either face or
extend away from the first layer 210.
[0067] The third layer 214 may also comprise or consist essentially
of a manifold. In some illustrative embodiments, the third layer
214 may comprise sealed regions defining a plurality of closed
cells 235. In some embodiments, the closed cells 235 may be filled
with fluid such as air. The third layer 214 may additionally
comprise apertures 240 between the closed cells 235 to allow fluid
transfer through the third layer 214. As mentioned with respect to
the second layer 212, the orientation of the third layer 214 may be
reversed.
[0068] The closed cells 235 are preferably resistant to collapsing
under therapeutic levels of negative pressure. In some embodiments,
closed cells 235 may be formed by a material have sufficient
tensile strength to resist stretching under apposition forces of
negative pressure. The tensile strength of a material is the
ability of material to resist stretching as represented by a
stress-strain curve where stress is the force per unit area, i.e.,
pascals (Pa), newtons per square meter (N/m.sup.2), or pounds per
square inch (psi). The ultimate tensile strength (UTS) is the
maximum stress the material can withstand while being stretched
before failing or breaking. Many materials display a linear elastic
behavior defined by a linear stress-strain relationship often
extending up to a nonlinear region represented by the yield point,
i.e., the yield strength of a material. For example, high-density
polyethylene (HDPE) has a high tensile strength and low-density
polyethylene (LDPE) has a slightly lower tensile strength, both of
which are suitable materials for forming the closed cells 235.
Linear low-density polyethylene (LLDPE) may be used as well because
the material stretches very little as the force is increased up to
the yield point of the material. The yield strength of HDPE ranges
from 26-33 MPa, and has a UTS of 37 MPa, while LDPE has somewhat
lower values. In some example embodiments, the closed cells 235 may
be formed from a material that has a yield strength greater than
about 20 MPa.
[0069] In the example of FIG. 2, the dressing 104 may further
include an attachment device, such as an adhesive 245. The adhesive
245 may be, for example, a medically-acceptable, pressure-sensitive
adhesive that extends about a periphery, a portion, or the entire
cover 116. In some embodiments, for example, the adhesive 245 may
be an acrylic adhesive having a coating weight between 25-65 grams
per square meter (g.s.m.). Thicker adhesives, or combinations of
adhesives, may be applied in some embodiments to improve the seal
and reduce leaks. In some embodiments, such a layer of the adhesive
245 may be continuous or discontinuous. Discontinuities in the
adhesive 245 may be provided by apertures or holes (not shown) in
the adhesive 245. The apertures or holes in the adhesive 245 may be
formed after application of the adhesive 245 or by coating the
adhesive 245 in patterns on a carrier layer such as a side of the
cover 116. Apertures or holes in the adhesive 245 may also be sized
to enhance the MVTR of the dressing 104 in some example
embodiments.
[0070] As illustrated in the example of FIG. 2, in some
embodiments, the dressing 104 may include a release liner 250 to
protect the adhesive 245 prior to use. The release liner 250 may
also provide stiffness to assist with, for example, deployment of
the dressing 104. The release liner 250 may be, for example, a
casting paper, a film, or polyethylene. Further, in some
embodiments, the release liner 250 may be a polyester material such
as polyethylene terephthalate (PET) or similar polar
semi-crystalline polymer. The use of a polar semi-crystalline
polymer for the release liner 250 may substantially preclude
wrinkling or other deformation of the dressing 104. For example,
the polar semi-crystalline polymer may be highly orientated and
resistant to softening, swelling, or other deformation that may
occur when brought into contact with components of the dressing 104
or when subjected to temperature or environmental variations, or
sterilization. Further, a release agent may be disposed on a side
of the release liner 250 that is configured to contact the first
layer 210. For example, the release agent may be a silicone coating
and may have a release factor suitable to facilitate removal of the
release liner 250 by hand and without damaging or deforming the
dressing 104. In some embodiments, the release agent may be a
fluorocarbon or a fluorosilicone, for example. In other
embodiments, the release liner 250 may be uncoated or otherwise
used without a release agent.
[0071] FIG. 2 also illustrates one example of a fluid conductor 255
and a dressing interface 260. As shown in the example of FIG. 2,
the fluid conductor 255 may be a flexible tube, which can be
fluidly coupled on one end to the dressing interface 260. The
dressing interface 260 may be an elbow connector, as shown in the
example of FIG. 2, which can be placed over an aperture 265 in the
cover 116 to provide a fluid path between the fluid conductor 255
and the tissue interface 114.
[0072] In some embodiments of the dressing 104, one or more
components of the dressing 104 may additionally be treated with an
antimicrobial agent. For example, the first layer 210, the second
layer 212, and/or the third layer 214 may be coated with an
antimicrobial agent. In some embodiments, the first layer 210 may
comprise a polymer coated or mixed with an antimicrobial agent. In
further embodiments, the second layer 212 and the third layer 214
may comprise films coated or mixed with an antimicrobial agent. In
other examples, the cover 116, the fluid conductor 255, the
dressing interface 260, or other portion of the dressing 104 may
additionally or alternatively be treated with one or more
antimicrobial agents. Suitable antimicrobial agents may include,
for example, metallic silver, PHMB, iodine or its complexes and
mixes such as povidone iodine, copper metal compounds,
chlorhexidine, or some combination of these materials.
[0073] FIG. 3 is a schematic view of an example of the first layer
210, illustrating additional details that may be associated with
some embodiments. As illustrated in the example of FIG. 3, the
fluid restrictions 220 may each consist essentially of one or more
linear slots having a length of about 3 millimeters. FIG. 3
additionally illustrates an example of a uniform distribution
pattern of the fluid restrictions 220. In FIG. 3, the fluid
restrictions 220 are substantially coextensive with the first layer
210 and are distributed across the first layer 210 in a grid of
parallel rows and columns, in which the slots are also mutually
parallel to each other. In some embodiments, the rows may be spaced
about 3 millimeters on center, and the fluid restrictions 220
within each of the rows may be spaced about 3 millimeters on center
as illustrated in the example of FIG. 3. The fluid restrictions 220
in adjacent rows may be aligned or offset. For example, adjacent
rows may be offset, as illustrated in FIG. 3, so that the fluid
restrictions 220 are aligned in alternating rows and separated by
about 6 millimeters. The spacing of the fluid restrictions 220 may
vary in some embodiments to increase the density of the fluid
restrictions 220 according to therapeutic requirements.
[0074] FIG. 4 is a perspective view of an example of the second
layer 212, illustrating additional details that may be associated
with some embodiments. As illustrated in the example of FIG. 4, the
blisters 225 may be generally hemispherical and uniformly
distributed in some embodiments.
[0075] FIG. 5 is a section view of the second layer 212 of FIG. 4,
illustrating additional details that may be associated with some
embodiments. For example, the second layer 212 may be formed of a
single sheet or film of fluid-impermeable material, which may have
the blisters 225 and apertures 230 formed thereon. In some
embodiments, the second layer 212 may be formed from a polyurethane
material. The blisters 225 may be formed in the second layer 212 by
applying a vacuum to the film of fluid-impermeable material of the
second layer 212 to create the blisters 225. The blisters 225 may
have dimensions that depend on the particular application of the
dressing 104. For example, each of the blisters 225 may have a
height between approximately 1.0 mm and 3.0 mm and may have a
diameter between approximately 1.0 mm and 3.0 mm. In some
embodiments, the blisters 225 may measure approximately 1.5 mm in
height and approximately 1.5 mm in diameter. The distance between
each of the blisters 225 may be between approximately 1.0 mm and
3.0 mm, and in some embodiments may have a spacing of approximately
2.0 mm.
[0076] As shown in FIG. 5, the apertures 230 may be formed in the
portions of the second layer 212 that are between the blisters 225
and may extend through the film of fluid-impermeable material to
permit fluids to flow through the second layer 212. The number of
apertures 230 may vary depending on the type of negative pressure
and instillation therapy to be provided by the therapy system 100.
The apertures 230 may have different shapes, such as, for example,
circular, elliptical, rectangular, or other irregular shape. Such
apertures 230 may have a diameter, major axis, or length between
about 0.5 mm and 1.5 mm. In some example embodiments, the apertures
230 may be formed by cutting or perforating the fluid-impermeable
material of the second layer 212.
[0077] FIG. 6 is a schematic view of an example of the third layer
214, illustrating additional details that may be associated with
some embodiments. The third layer 214 may include a first sheet 602
and a second sheet 603 in some embodiments. For example, each of
the first sheet 602 and the second sheet 603 may comprise or
consist essentially of a non-porous polymer film, having inner
surfaces coupled to each other to form a sealed region 606 defining
a plurality of closed cells 235. The inner surfaces may be coupled
to each other to form closed cells 235 that are substantially
airtight to inhibit excessive collapsing of the closed cells 235
from the application of negative pressure, which could block the
flow of fluid through the third layer 214.
[0078] The two sheets of non-porous, polymeric film, first sheet
602 and second sheet 603, may be in the form of a single sheet of
material having two laminae or two separate sheets that are coupled
together to form the closed cells 235. The sheets of non-porous,
polymeric film may initially be separate sheets that are brought
into superposition and sealed or they may be formed by folding a
single sheet unto itself with a heat sealable surface facing
inward. Each sheet of the non-porous polymeric film also may be a
monolayer or multilayer structure depending on the application of
the desired structure of the closed cells 235.
[0079] The sheets of non-porous, polymeric film may comprise any
flexible material that can be manipulated to enclose closed cells.
For example, the third layer 214 may be formed of two welded layers
of polyolefin film that encapsulates air in pockets. Additionally
or alternatively, various thermoplastic materials may be used for
producing the film layers of the third layer 214. Non-limiting
examples of suitable thermoplastic polymers include polyethylene
homopolymers, such as low density polyethylene (LDPE) and high
density polyethylene (HDPE), and polyethylene copolymers, such as,
ionomers, EVA, EMA, heterogeneous (Zeigler-Natta catalyzed)
ethylene/alpha-olefin copolymers, and homogeneous (metallocene,
single-cite catalyzed) ethylene/alpha-olefin copolymers.
Ethylene/alpha-olefin copolymers are copolymers of ethylene with
one or more comonomers selected from C.sub.3 to C.sub.20
alpha-olefins, such as 1-butene, 1-pentene, 1-hexene, 1-octene, and
methyl pentene, in which the polymer molecules comprise long chains
with relatively few side chain branches, including linear
low-density polyethylene (LLDPE), linear medium-density
polyethylene (LMDPE), very low-density polyethylene (VLDPE), and
ultra-low-density polyethylene (ULDPE). Various other materials are
also suitable such as, polypropylene homopolymer or polypropylene
copolymer (e.g., propylene/ethylene copolymer), polyesters,
polystyrenes, polyamides, polycarbonates, etc.
[0080] In some example embodiments, the sealed region 606 may be
formed by a heat seal between the inner surfaces of sheet 602 and
sheet 603. Additionally or alternatively, the sealed region 606 may
be formed by adhesion between the sheet 602 and the sheet 603. The
sheet 602 and sheet 603 may also be adhesively bonded to each
other. The closed cells 235 may be substantially airtight when
formed and have an internal pressure that is substantially an
ambient pressure. In other embodiments, the closed cells 235 may be
inflated with air or other suitable gas, such as, for example,
carbon dioxide or nitrogen. The closed cells 235 may be inflated to
have an internal pressure greater than the atmospheric pressure to
maintain their shape and resistance to collapsing under pressure.
For example, the closed cells 235 may be inflated to a pressure up
to about 25 psi above the atmospheric pressure so that they do not
collapse.
[0081] The sealed region 606 comprises sealed segments between the
closed cells 235 that may be flexible enough so that the third
layer 214 is sufficiently flexible to conform to the shape of the
tissue site. The sealed segments may be sufficiently flexible or
sized so that the third layer 214 may be folded into two or more
layers. The sealed segments of the sealed region 606 may serve as
common boundaries between adjacent closed cells 235. The sealed
segments of the sealed region 606 may also be perforated to provide
pathways for fluid to flow through the third layer 214. In some
example embodiments, the sealed region 606 may include a plurality
of apertures 240 between the closed cells 235 in the sealed region
606 and extending through both the sheet 602 and the sheet 603 to
permit fluid to flow through the third layer 214. The number of
apertures 240 may vary depending on the type of negative pressure
and instillation therapy to be provided by the therapy system 100.
The apertures 240 may have different shapes, such as, for example,
circular, elliptical, rectangular, or other irregular shape. Such
apertures 240 may have a diameter, major axis, or length between
about 0.5 mm and 1.5 mm. In other example embodiment, the apertures
240 may be formed by perforating or cutting the segments of the
sealed region 606.
[0082] As illustrated in the example of FIG. 6, the sealed region
606 may define the base or the cross-sectional shape of each of the
closed cells 235 as generally circular. Additionally or
alternatively, the base of one or more of the closed cells 235 may
have other shapes, such as rectangular, triangular, or hexagonal.
The closed cells 235 may be formed with a three-dimensional shape
corresponding to the cross-sectional shape of the closed cells 235.
For example, the volumetric shape may be generally hemispherical or
spherical in shape as shown. In other example embodiments, the
closed cells 235 may be formed with a volumetric shape that is
generally conical, cylindrical, tubular having a flattened or
hemispherical end, or geodesic shape. The closed cells 235 that are
generally hemispherical or spherical in shape may have a diameter
between about 0.5 mm and 10 mm. The closed cells 235 also may have
a pitch, i.e., the center to center distance between each of the
closed cells 235, between about 1.5 mm and 15 mm. Because the
sealed region 606 defines the base of the closed cells 235
including the diameter of a circular base and the pitch of adjacent
closed cells 235, the surface area of the third layer 214 covered
by the closed cells 235 may also be determined as a percentage,
i.e., the cell coverage percentage. In one example embodiment
wherein the diameter of the closed cells 235 is about 1.0 mm and
the pitch is about 2.0 mm, the cell coverage percentage is about
22% of the surface area of the third layer 214. In another example
embodiment wherein the diameter of the closed cells 235 is about
2.0 mm and the pitch is about 5.0 mm, the cell coverage percentage
is about 14% of the surface area of the third layer 214. In yet
another example embodiment wherein the diameter of the closed cells
235 is about 1.0 mm and the pitch is about 1.5 mm, the cell
coverage percentage is about 30% of the surface area of the third
layer 214. In still another example embodiment wherein the diameter
of the closed cells 235 is about 1.5 mm, the pitch is about 2.0 mm,
and the closed cells 235 are more tightly arranged such that there
are about 28.5 cells in a 10 mm.sup.2 section of the third layer
214, the cell coverage percentage is about 51% of the surface area
of the third layer 214. Depending on the diameter, pitch, and
arrangement of the closed cells 235, the cell coverage percentage
may range between about 10% and about 55% of the surface area of a
manifold. Closed cells 235 having other base shapes or volumetric
shapes also may have a cell coverage percentage in generally the
same range.
[0083] Some embodiments of the closed cells 235 may have
three-dimensional shapes, including hemispherical shapes, spherical
shapes, conical shapes, cylindrical shapes, or tubular shapes
formed with a flattened or hemispherical end. These shapes may be
formed in one or both of sheet 602 and sheet 603, such as the
single hemispherical shape shown in FIG. 7 (closed cells 704) and
the two hemispherical shapes that are aligned with one another to
form a spherical shape as shown in FIG. 8 (closed cells 804). The
closed cells 235 may have a height between about 0.25 mm and about
5 mm, e.g., about half the diameter of closed cells 235 having a
hemispherical shape as described in the examples above. In some
embodiments, the closed cells 235 may measure about 10 mm in
diameter and about 3 mm in height. In other example embodiments,
the closed cells 235 may have a generally tubular shape formed with
generally parallel walls extending from the sealed region 606 to a
hemispherical end. In yet other example embodiments, closed cells
235 having a tubular shape may have a diameter of about 1.5 mm and
an average height in a range between about 2.0 mm and 4.0 mm.
[0084] Still referring primarily to FIG. 6, the sheet 602 and the
sheet 603 may each have a thickness of about 5 .mu.m to 500 .mu.m,
and the sealed region 606 may have a thickness between about 10
.mu.m and 1000 .mu.m. The walls of the closed cells 235 after being
formed by coupling the sheet 602 and the sheet 603 together may
have a thickness relative to the thickness of the sheet 602 and the
sheet 603 defined by a draw ratio, which is the ratio of the
average height of the closed cells 235 to the average thickness of
the sheet 602 and the sheet 603. In one example embodiment where
the closed cells 235 have a generally tubular shape, the sheets 602
and 603 may have an average thickness of 250 .mu.m and the closed
cells 235 may have an average height in a range between about 2.0
mm and 4.0 mm with a diameter of about 1.5 mm. Consequently, the
closed cells 235 have a draw ratio ranging from about 8:1 to about
16:1 for heights of 2.0 and 4.0 mm, respectively. In another
example embodiment, the sheets 602 and 603 may have an average
thickness of 100 .mu.m and the closed cells 235 may have an average
height in a range between about 2.0 mm and 4.0 mm with a diameter
of about 1.5 mm. Consequently, the closed cells 235 have a draw
ratio ranging from about 20:1 to about 40:1 for heights of 2.0 and
4.0 mm, respectively. In yet other example embodiments, it is
desirable that the draw ratio be greater than about 16:1 where the
thickness of the sheets 602 and 603 is less than about 250 .mu.m.
The sheets 602 and 603 may each have the same or different
thicknesses and flexibilities, but are substantially
non-stretchable as described above so that the closed cells 235
maintain a generally constant volume without bursting after
negative pressure or instillation fluid is applied to the third
layer 214. Consequently, even when a load is applied to the third
layer 214 which squeezes closed cells 235 into a different shape,
the closed cells 235 are sufficiently flexible to recover their
original shape after being squeezed without bursting.
[0085] FIG. 7 is a section view of another example of the third
layer 214, illustrating additional details that may be associated
with some embodiments. For example, the third layer 214 of FIG. 7
may be configured so that the closed cells extend from only one
side of the sealed region of the third layer 214, such as closed
cells 704 having a hemispherical shape. More specifically, the
third layer 214 may comprise two sheets of polymeric film, a first
sheet 712 and a second sheet 713, having inner surfaces coupled to
each other in a pattern defining a plurality of closed cells 704.
The sheets 712 and 713 may be sealed to each other in a sealed
region 716 that defines the closed cells 704 that are generally
hemispherical in shape. The closed cells 704 may be formed on only
one side of the sealed region 716 by using sheets of polymeric film
having a different thickness or flexibility. For example, the
closed cells 704 may be formed in the sheet 713 by applying a
vacuum to the sheet 713 where the sheet 712 is sufficiently thicker
than the sheet 713 to withstand the vacuum being applied and retain
a generally planar shape. The closed cells 704 having other shapes
may be formed to extend from only one side of the sealed region 716
and may be formed by using a variety of different methods. For
example, the shape of the closed cells 704 may be formed separately
in the sheet 713, which can be subsequently coupled to the sheet
712 to complete the encapsulation of the closed cells 704. The
sheet 712 may have the same thickness as the sheet 713 so that the
sealed region 716 remains thin and flexible.
[0086] In some embodiments, the third layer 214 may further include
textured surface features on one or more surfaces of either or both
of the sheets 712 and 713. The textured surface features may be
included on a surface of either or both of the sheets 712 and 713
that may be placed facing the tissue site. The textured surface
features may be protrusions or indentations for enhancing fluid
flow through the third layer 214 and to increase micro-strains
against the tissue site for enhancing granulation. More
specifically, the textured surface features may include a pattern
of individual nodes or projections embossed on the outer surface of
the sheet 712 and/or sheet 713, a grid embossed on the outer
surface of the sheet 712 and/or sheet 713, a pattern or grid of
grooves formed into the outer surface of the sheet 712 and/or 713,
or any combination of the foregoing. For example, as shown in FIG.
7, the third layer 214 may include textured surface features in the
form of nodes 719, which may be embossed on the outer surface of
the sheet 712 that is generally planar so that the nodes 719
contact the tissue site when the third layer 214 is positioned at
the tissue site.
[0087] The nodes 719 may be projections that are flexible or rigid.
In some embodiments, the projections may be formed from a
substantially gas-impermeable material such as silicone. In other
embodiments, the projections may be formed from a
semi-gas-permeable material. The projections may be formed as an
integral part of the sheets 712 and 713, and they may also be
formed from the same material as the sheets 712 and 713. In some
embodiments, the projections may be solid, while in other
embodiments, the projections may be hollow to increase flexibility.
The projections may form a plurality of channels and/or voids as
described below to distribute negative pressure and allow for fluid
flow among the projections. The projections may be dimensioned to
provide local load points at a tissue site sufficient to create
micro-strains at the tissue site for stimulating granulation
formation when negative pressure is applied. The pattern and
position of the projections may be uniform or non-uniform. The
projections may have different shapes including, for example, the
shape of a spike, cone, pyramid, dome, cylinder, or rectangle. The
shapes of the projections may be uniform or non-uniform depending
on the tissue site. The shapes of the projections may occupy a
volume defined by a cube volume where the side of the cube would
range from approximately 0.2 mm approximately 1.5 mm. In one
embodiment, the spike shape may have a base width or diameter of
about 0.2 mm and a vertical height of between about 0.4 mm and 0.8
mm. In another embodiment, the cone shape may have a base diameter
of about 0.4 mm and a vertical height of between 0.4 mm to 1.2 mm.
In yet another embodiment, the dome shape may have a spherical cap
or parabolic shape with a base diameter ranging from about 0.4 mm
to 1 mm.
[0088] FIG. 8 is a section view of another example of the third
layer 214, illustrating additional details that may be associated
with some embodiments. For example, the third layer 214 of FIG. 8
may include portions of closed cells that are formed in both of the
two sheets of the third layer 214, so that the portions closed
cells extend from both sides of the sealed region of the third
layer 214. More specifically, the third layer 214 may comprise two
sheets of polymeric film, sheet 832 and sheet 833, having inner
surfaces coupled to each other in a pattern defining a plurality of
closed cells 804. For example, the portions of closed cells formed
in each of the sheets 832 and 833 may be hemispherical in shape,
such as hemispherical cell 844 and hemispherical cell 854. The
hemispherical cell 844 and hemispherical cell 854 may then be
aligned to form a single closed cell 804 having a generally
spherical shape. In other words, each of the single closed cells
804 comprises two hemispherical cells, hemispherical cell 844 and
hemispherical cell 854, formed in the sheets 832 and 833,
respectively. The sheets 832 and 833 may be sealed to each other in
a sealed region 836 that defines the closed cells 804 that are
generally spherical in shape. In other example embodiments, the
closed cells in each sheet may not be aligned with each other, but
rather are overlapped or aligned with the sealed portion of the
opposite sheet. The closed cells 804 may be formed on both sides of
the sealed region 836 by using sheets of polymeric film having a
different thickness or flexibility. For example, the shape of the
closed cells 804 may be asymmetric when the sheets 832 and 833 have
different thicknesses or flexibilities from each other. However,
when the sheets 832 and 833 have substantially identical thickness
or flexibility, the shape of the closed cells 804 may be
substantially spherical as shown in FIG. 8.
[0089] FIG. 9 is a section view of another example of the third
layer 214, illustrating additional details that may be associated
with some embodiments. For example, the third layer 214 of FIG. 9
may include a third sheet forming a multi-sheet configuration where
the third sheet is disposed between a first sheet and a second
sheet to form closed cells that may be generally spherical in shape
formed by two hemispherical sections separated by portions of the
third sheet of material. For example, the third layer 214 may
include sheet 922 and sheet 923 of polymeric film having inner
surfaces coupled or bonded to a third sheet 928 to form sealed
region 926 defining a plurality of closed cells 924. The closed
cells 924 are generally spherical in shape and formed by two
hemispherical sections that are separated by portions of the third
sheet 928. Sheet 922 and sheet 923 may be coupled or bonded to the
third sheet 928 using a variety of different methods including, for
example, melting (e.g., RF, ultrasonic, and heat), adhesives using
both hot melt and solvents, and pressing techniques. The third
sheet 928 may be formed from a polymeric film and may also be
perforated to permit airflow between the two hemispherical sections
of the closed cells 924. When the third sheet 928 is formed from a
polymeric material, the third sheet 928 may also be textured to
provide wicking capability. The third sheet 928 may also be formed
from a polyester material to provide wicking within the closed
cells 924 and may further include fibers flocked into the polyester
material to provide additional wicking capability. The third sheet
928 may also include an antimicrobial layer or antimicrobials
coated on the third sheet 928.
[0090] In some embodiments, the third layer 214 of FIG. 9 may also
include textured surface features on one or more surfaces of either
or both of the sheets 922 and 923. The textured surface features
may be protrusions or indentations, as discussed with respect to
the textured surface features of FIG. 7. For example, the third
layer 214 may include projections or nodes 929 embossed on the
outer surface of the sheet 922 and, more specifically, on the
surface of the closed cells 924 so that the nodes 929 contact the
tissue site if the third layer 214 is positioned at the tissue
site.
[0091] FIG. 10 is a schematic view of another example of the third
layer 214, illustrating additional details that may be associated
with some embodiments. For example, a number of different textures
or shapes may be formed on the outside surface of a first sheet
1002 that may be flat and may be for facing a tissue site when in
use. In one exemplary embodiment, a grid 1049 may be embossed or
extruded in a woven pattern on the outer surface of the first sheet
1002. The pattern of the grid 1049 may have a variety of shapes,
like the diamond-shaped pattern shown. It should be understood that
many types of protrusions or grids may be formed on a surface of
the first sheet 1002 or a first sheet of other disclosed
embodiments of the third layer 214 for enhancing fluid flow through
or along the third layer 214 and/or enhance granulation of a tissue
site. Moreover, it should be understood that any of such
protrusions or grids may be formed by embossing, welding, or any
other similar type of coupling mechanism.
[0092] FIG. 11 is a schematic view of another example of a third
layer 1100, illustrating additional details that may be associated
with some embodiments. The third layer 1100 may be similar to the
embodiments of third layer 214 previously discussed but may further
include chambers formed by interconnected closed cells to better
distribute the apposition force applied to the third layer 1100 as
a result of the application of negative pressure since the volume
of the chambers is greater than the volume of the individual closed
cells. In one embodiment, as shown in FIG. 11, the third layer 1100
includes a sheet 1102 and a sheet 1103, each of which may be a
polymeric film having inner surfaces coupled to each other in a
pattern defining a plurality of closed cells 1104. The sheets 1102
and 1103 may be sealed to each other to form a sealed region 1106
defining the closed cells 1104. The sealed region 1106 may also be
perforated to provide pathways for fluid to flow through the third
layer 1100. In one exemplary embodiment, the sealed region 1106 may
comprise a plurality of apertures 1105 that are formed between the
closed cells 1104 in the sealed region 1106 that extend through
both of the sheets 1102 and 1103 to permit fluid flow through the
third layer 1100. The third layer 1100 may also comprise a
plurality of passageways 1108 fluidly coupling at least two of the
closed cells 1104 to form a closed chamber. In one exemplary
embodiment, a closed chamber 1148 is formed by all of the closed
cells 1104 in a row fluidly coupled by the passageways 1108 as
shown in FIG. 11. Closed chambers 1148 may be formed in each of the
other six rows as also shown in FIG. 11. The formation of closed
chambers with closed cells in any pattern may distribute apposition
forces applied to the third layer 1100 more equally across the
third layer 1100.
[0093] FIG. 12 is a section view of another example of the third
layer 1100, illustrating additional details that may be associated
with some embodiments. For example, the third layer 1100 of FIG. 12
may include two sheets of polymeric film, sheet 1112 and sheet
1113, having inner surfaces coupled to each other in a pattern
defining a plurality of closed cells 1114. The sheets 1112 and 1113
may be sealed to each other in a sealed region that defines the
closed cells 1114 that are generally hemispherical in shape. The
third layer 1100 also may comprise a plurality of passageways 1118
interconnecting the closed cells 1114 to form a closed chamber
1158. The closed chamber 1158 may be formed in only one of the
sheets 1112 and 1113 so that they extend from only one side of the
sealed region as shown in FIG. 12.
[0094] FIG. 13 is a section view of another example of the third
layer 1100, illustrating additional details that may be associated
with some embodiments. For example, the third layer 1100 of FIG. 13
may include two sheets of polymeric film, sheet 1132 and sheet
1133, having inner surfaces coupled to each other in a pattern
defining a plurality of closed cells 1134. The sheets 1132 and 1133
may be sealed to each other in a sealed region that defines the
closed cells 1134 that are generally spherical in shape. The third
layer 1100 also may comprise a plurality of passageways 1138
interconnecting the closed cells 1134 to form a closed chamber
1178. The closed chamber 1178 is formed in both of the sheets 1132
and 1133 so that they extend from both sides of the sealed region
that provides more flexibility and cushioning than the closed
chamber 1158 extending from only one side of the sealed region.
[0095] FIG. 14 is a section view of another example of the third
layer 1100, illustrating additional details that may be associated
with some embodiments. For example, the third layer 1100 of FIG. 14
may include two sheets of polymeric film, sheet 1122 and sheet
1123, having inner surfaces coupled or bonded to a third sheet 1128
to form a sealed region defining a plurality of closed cells 1124.
The closed cells 1124 are generally spherical in shape and formed
by two hemispherical sections that are separated by portions of the
third sheet 1128. Sheet 1122 and sheet 1123 may be coupled or
bonded to the third sheet 1128 using a variety of different methods
including, for example, melting (e.g., RF, ultrasonic, and heat),
adhesives using both hot melt and solvents, and pressing
techniques. The third sheet 1128 may be formed from a polymeric
film and may also be perforated to permit airflow between the two
hemispherical sections of the closed cells 1124. When the third
sheet 1128 is formed from a polymeric material, the third sheet
1128 may also be textured to provide wicking capability. The third
sheet 1128 may also be formed from a polyester material to provide
wicking within the closed cells 1124, and may further include
fibers flocked into the polyester material to provide additional
wicking capability. The third sheet 1128 also may include an
antimicrobial layer or antimicrobials coated on the third sheet
1128. The third layer 1100 of FIG. 14 may also include a plurality
of passageways 1198 interconnecting the closed cells 1124 to form a
closed chamber 1168. The closed chamber 1168 is formed in both of
the sheets 1122 and 1123 so that they extend from both sides of the
sealed region.
[0096] FIG. 15 is a schematic view of another example of a third
layer 1200, illustrating additional details that may be associated
with some embodiments. The third layer 1200 may be similar to the
embodiments of the third layer 214 previously discussed but may
include different arrangements of closed cells, which may be
suitable for particular forms of therapy being utilized. Previously
discussed with respect to FIG. 6 were closed cells 235 which are in
a staggered arrangement so that the individual cells may be more
closely nested together between the alternating rows to form a
nested pattern of cells formed on the same plane as defined by the
sealed region 606. FIG. 15 depicts a third layer 1200 that may
include two sheets 1202 and 1203 of polymeric film having inner
surfaces sealed to each other in a pattern defining a plurality of
closed cells 1204 in close proximity to one another. However, the
rows and columns of closed cells 1204 are not staggered, but rather
arranged in an aligned pattern. Depending on the diameter and pitch
of the closed cells 1204, the cell coverage percentage may range
between about 10% and about 55% of the surface area of the third
layer 1200. The sheets 1202 and 1203 may be sealed to each other in
a sealed region 1206 that defines the closed cells 1204. In this
embodiment, the rows and columns of the closed cells 1204 are
arranged in line to form an aligned pattern. The third layer 1200
may also include a sealed region 1206 that may be perforated as
described above. In some embodiments, the sealed region 1206 may
include a plurality of apertures 1205 between the closed cells 1204
and extending through both the sheet 1202 and the sheet 1203 to
permit fluid to flow through the third layer 1200. The apertures
1205 may have similar dimensions as apertures 240 of FIG. 6. The
pattern of closed cells 1204 may have a variety of
arrangements.
[0097] FIG. 16 is a schematic view of another example of a third
layer 1300, illustrating additional details that may be associated
with some embodiments. The third layer 1300 may be similar to the
third layer 1200 of FIG. 15 and may include two sheets 1302 and
1303 of polymeric film having inner surfaces sealed to each other
in a pattern defining a plurality of closed cells 1304 in close
proximity to one another. The sheets 1302 and 1303 may be sealed to
each other in a sealed region 1306 that defines the closed cells
1304. The sealed region 1306 may also be perforated to provide
pathways for fluid to flow through the third layer 1300. In one
exemplary embodiment, the sealed region 1306 may comprise a
plurality of apertures 1305 that are formed between the closed
cells 1304 in the sealed region 1306 that extend through both of
the sheets 1302 and 1303 to permit fluid flow through the third
layer 1300. The third layer 1300 may also comprise a plurality of
passageways 1308 interconnecting the closed cells 1304 to form a
closed chamber. In one exemplary embodiment, a closed chamber 1348
is formed by all of the closed cells 1304 in a row fluidly coupled
by the passageways 1308 as shown in FIG. 16. Closed chambers 1348
may be formed in each of the other six rows, or formed to include
multiple rows, as also shown in FIG. 16. The formation of closed
chambers 1348 with closed cells 1304 in any pattern may distribute
apposition forces applied to the third layer 1300 more equally
across the third layer 1300 as opposed to a layer having only
closed cells.
[0098] Referring again primarily to FIG. 2, the individual
components of the dressing 104 may be bonded or otherwise secured
to one another with a solvent or non-solvent adhesive or with
thermal welding, for example, without adversely affecting fluid
management. For example, the layers of the tissue interface 114,
such as the first layer 210, the second layer 212, and the third
layer 214 may be laminated to each other. In some embodiments, a
low-melting-point (approximately 60.degree. C., for example) hot
melt adhesive mesh may be applied to the bonding surfaces of any or
all of the first layer 210, the second layer 212, and the third
layer 214, prior to any perforations being made in the layers. The
layers, which may be film layers, may then be laminated together
under relatively low compression and heat application to soften the
hot melt mesh in order to complete the bonding. Additionally or
alternatively, the layers of the tissue interface 114 and dressing
104 may be welded together in an array or pattern such that a
textured `spot weld` pattern is formed using RF, ultrasonics, or
heat.
[0099] The individual components of the dressing 104, such as the
cover 116, the first layer 210, the second layer 212, and the third
layer 214, or various combinations, may be assembled before
application or in situ. For example, the cover 116 may be laminated
to the first layer 210, and the second layer 212 may be laminated
to the first layer 210 opposite the cover 116 in some embodiments.
Additionally, the third layer 214 may be laminated to the second
layer 212 opposite the first layer 210. In some embodiments, one or
more layers of the tissue interface 114 may be coextensive. For
example, the first layer 210, the second layer 212, and the third
layer 214 may be cut flush with the edges of each other, thus
exposing the edges of all three layers. In other embodiments, any
one of the first layer 210, the second layer 212, and the third
layer 214 may overlap the edge of any of the other layers. In some
embodiments, the dressing 104 may be provided as a single,
composite dressing. For example, the second layer 212 and the third
layer 214 may be positioned between portions of the first layer
210, where a portion of the first layer 210 may be coupled to the
cover 116 and another portion of the first layer 210 may be
configured to face a tissue site.
[0100] In use, the release liner 250 (if included) may be removed
to expose the first layer 210, which may be placed within, over,
on, or otherwise proximate to a tissue site, particularly a surface
tissue site, and adjacent epidermis. The first layer 210 may be
interposed between the second layer 212 and the tissue site and
adjacent epidermis, which can substantially reduce or eliminate
interaction with the second layer 212 or third layer 214. For
example, the first layer 210 may be placed over a surface wound
(including edges of the wound) and undamaged epidermis. Treatment
of a surface wound or placement of the dressing 104 on a surface
wound includes placing the dressing 104 immediately adjacent to the
surface of the body or extending over at least a portion of the
surface of the body. Treatment of a surface wound may not include
placing the dressing 104 wholly within the body or wholly under the
surface of the body. The cover 116 may be sealed to an attachment
surface, such as epidermis peripheral to a tissue site, around the
first layer 210, the second layer 212, and the third layer 214.
[0101] The geometry and dimensions of the tissue interface 114, the
cover 116, or both may vary to suit a particular application or
anatomy. For example, the geometry or dimensions of the tissue
interface 114 and the cover 116 may be adapted to provide an
effective and reliable seal against challenging anatomical
surfaces, such as an elbow or heel, at and around a tissue site.
Additionally or alternatively, the dimensions may be modified to
increase the surface area for the first layer 210 to enhance the
movement and proliferation of epithelial cells at a tissue site and
reduce the likelihood of granulation tissue in-growth.
[0102] Further, the dressing 104 may permit re-application or
re-positioning to reduce or eliminate leaks, which can be caused by
creases and other discontinuities in the dressing 104 or a tissue
site. The ability to rectify leaks may increase the reliability of
the therapy and reduce power consumption in some embodiments.
[0103] Thus, the dressing 104 in the example of FIG. 2 can provide
a sealed therapeutic environment proximate to a tissue site,
substantially isolated from the external environment, and the
negative-pressure source 102 can reduce the pressure in the sealed
therapeutic environment. Negative pressure in the sealed
environment may compress the second layer 212 and/or the third
layer 214 into the first layer 210, which can deform the surface of
the first layer 210 to provide an uneven, coarse, or jagged profile
that can induce macrostrain and micro-strain in the tissue site in
some embodiments.
[0104] If not already configured, the dressing interface 260 may be
disposed over the aperture 265 and attached to the cover 116. The
fluid conductor 255 may be fluidly coupled to the dressing
interface 260 and to the negative-pressure source 102.
[0105] Negative pressure applied through the tissue interface 114
can create a negative pressure differential across the fluid
restrictions 220 in the first layer 210, which can open or expand
the fluid restrictions 220. For example, in some embodiments in
which the fluid restrictions 220 may comprise perforations through
the first layer 210, a pressure gradient across the perforations
can strain the adjacent material of the first layer 210 and
increase the dimensions of the perforations to allow liquid
movement through them, similar to the operation of a duckbill
valve. Opening the fluid restrictions 220 can allow exudate and
other liquid movement through the fluid restrictions 220 into the
second layer 212, the third layer 214, and the container 106. If
the negative-pressure source 102 is removed or turned-off, the
pressure differential across the fluid restrictions 220 can
dissipate, allowing the fluid restrictions 220 to return to an
unstrained or resting state and prevent or reduce the return rate
of exudate or other liquid moving to the tissue site through the
first layer 210.
[0106] Additionally or alternatively, instillation solution or
other fluid may be distributed to the dressing 104, which can
increase the pressure in the tissue interface 114. The increased
pressure in the tissue interface 114 can create a positive pressure
differential across the fluid restrictions 220 in the first layer
210, which can open or expand the fluid restrictions 220 from their
resting state to allow the instillation solution or other fluid to
be distributed to the tissue site.
[0107] FIG. 17 is an assembly view of another example of the tissue
interface 114 of FIG. 1, illustrating additional details that may
be associated with some embodiments. In the example of FIG. 17, the
third layer 214 may be disposed between the second layer 212 and
may also be disposed between the first layer 210. In the example of
FIG. 17, the third layer 214 may include two separate layers, with
each of the separate layers including closed cells. Additional
layers of closed cells in the third layer 214 may increase the
conformable compression feel to the tissue interface 114. The two
separate layers of closed cells can be positioned proximate to or
against each other. The two layers of the third layer 214 may be
positioned between the second layer 212, with the second layer 212
positioned adjacent to two sides of the third layer 214. In some
embodiments, for example, the second layer 212 may be laminated or
otherwise mechanically bonded to two sides of the third layer 214.
Additionally, the first layer 210 may be disposed adjacent to two
sides of the second layer 212, and in some embodiments, the first
layer 210 may be laminated or otherwise bonded to two sides of the
second layer 212. The first layer 210, the second layer 212, and
the third layer 214 may be stacked so that the second layer 212 is
adjacent to and in contact with the first layer 210 and the third
layer 214. The second layer 212 may also be bonded to the first
layer 210, the third layer 214, or both in some embodiments.
[0108] In the embodiment of FIG. 17, each of the two separate
layers of the third layer 214 may be oriented so that the closed
cells 235 of each of the separate layers are facing opposite
directions from each other. For example, the closed cells 235 on a
first of the two layers of the third layer 214 may be facing or
protruding upwards towards a first side of the tissue interface
114, while the closed cells 235 of a second of the two layers of
the third layer 214 may be facing or protruding downwards towards a
second side of the tissue interface 114. In other embodiments (not
shown), the two layers of the third layer 214 may be oriented so
that the closed cells are facing each other. For example, the third
layer 214 may include two layers having hemispherical closed cells
which face each other.
[0109] FIG. 18 is an assembly view of another example of the tissue
interface 114 of FIG. 1, illustrating additional details that may
be associated with some embodiments. The tissue interface 114 of
FIG. 18 may be similar to the tissue interface 114 of FIG. 17, with
the exception of the third layer 214 comprising three separate
layers that may be positioned proximate to or against each other.
The three separate layers of the third layer 214 may be positioned
between the second layer 212, which may be positioned between the
first layer 210. In the embodiment of FIG. 18, the three separate
layers of the third layer 214 may be oriented so that the closed
cells 235 of a first and second layers of the third layer 214 may
be facing or protruding upwards towards a first side of the tissue
interface 114, while the closed cells 235 of the third of the three
layers of the third layer 214 may be facing or protruding downwards
towards a second side of the tissue interface 114. In other
embodiments, the three layers of the third layer 214 may be
positioned so that the closed cells 235 are oriented in a variety
of different combinations.
[0110] FIG. 19 is an assembly view of another example of the tissue
interface 114 of FIG. 1. In the example of FIG. 19, the second
layer 212 is disposed between the first layer 210 and the third
layer 214. The embodiment of the tissue interface 114 illustrated
in FIG. 19 may be such that the third layer 214 is adapted for
being placed directly against a tissue site. For example, the
tissue interface 114 of FIG. 19 may be a side-specific, as opposed
to a reversible or side-independent structure. However, it may also
be that the orientation of the tissue interface 114 of FIG. 19 may
be reversed such that the first layer 210 is for positioning
against a tissue site. Depending on which layer of the tissue
interface 114 faces the tissue site, the tissue interface 114 of
FIG. 19 may cause different responses from a tissue site.
Additionally, the third layer 214 may be positioned so that the
closed cells 235 either face upwards or downwards.
[0111] In the example of FIG. 19, the closed cells 235 of the third
layer 214 may be positioned on an inward surface of the third layer
214, therefore, placing the closed cells 235 in contact with the
second layer 212. The closed cells 235 may form a plurality of
channels with the second layer 212 for providing passageways for
fluid flow for both negative pressure and instillation liquids
during therapy sessions. The apertures 240 of the third layer 214
may fluidly couple the channels formed between the third layer 214
and the second layer 212 with the voids to facilitate the
transmission of negative pressure and the movement of fluids. As
discussed above with respect to other example embodiments of the
tissue interface 114, the apertures 240 placed between the closed
cells 235 of the third layer of FIG. 19 may measure about 1 mm or
greater in diameter.
[0112] If negative pressure is applied to the third layer 214, the
third layer 214 may be compressed under the cover 116, which may
cause the cover 116 to collapse toward the tissue site. For
example, in embodiments where the orientation of the tissue
interface 114 is such that the third layer 214 is adjacent to the
cover 116, the collapsing force of the cover 116 downward on the
upper surfaces of the closed cells 235 may be transmitted via the
closed cells 235. In some embodiments, the third layer 214 may
include nodes or projections. For example, the third layer 214 may
be disposed at a tissue site so that the nodes extend outwardly
from the third layer 214 and contact the tissue site. The nodes may
form voids between the outside surface of the third layer 214 and
the tissue site. The nodes may be compressed into the tissue site
for increasing micro-strains on the tissue site for enhancing
granulation. Although the closed cells 235 may change shape or
flatten somewhat during the application of negative pressure to the
third layer 214, the volume of the closed cells 235 can remain
substantially constant. The third layer 214 can transmit downward
forces to the nodes while maintaining fluid flow through the
channels to continue providing negative-pressure therapy to the
tissue site. Consequently, the third layer 214 can apply apposition
forces to the nodes, which can enhance granulation while
maintaining fluid communication with a tissue site via the channels
and the voids. The flexibility of the closed cells 235 can also
facilitate movement of the nodes as negative pressure increases
and/or is varied during treatment so that the additional movement
can further enhance granulation.
[0113] FIG. 20 is an assembly view of another example of the tissue
interface 114 of FIG. 1. In the example of FIG. 20, the tissue
interface 114 may include the first layer 210 and the second layer
212 disposed adjacent to the first layer 210. Thus, in some
embodiments, the tissue interface 114 may be in the form of a
two-layer construct for placing against a tissue site. Depending on
the particular needs of the tissue site, the two-layer construct of
the example tissue interface 114 of FIG. 20 may be placed with
either the first layer 210 or the second layer 212 against the
surface of the tissue site. Additionally, depending on the
particular embodiment, the orientation of the second layer 212 may
be reversed. For example, in some embodiments, the second layer 212
may be oriented against the first layer 210 so that the blisters
225 may protrude away from the first layer 210, as shown in the
example of FIG. 20. In other embodiments, the second layer 212 may
be oriented against the first layer 210 so that the blisters 225
face, or come into contact with the first layer 210.
[0114] FIG. 21 is an assembly view of another example of the tissue
interface 114 of FIG. 1. Similar to the example shown in FIG. 20,
the tissue interface 114 of FIG. 21 may be in the form of a
two-layer construct for placing against a tissue site. The tissue
interface 114 of FIG. 21 may include the first layer 210 and the
third layer 214 disposed adjacent to the first layer 210. The
tissue interface 114 of FIG. 21 may be placed with either the first
layer 210 or the third layer 214 against the surface of the tissue
site. As mentioned with respect to FIG. 20, the orientation of the
third layer 214 of the tissue interface 114 of FIG. 21 may be
reversed so that the closed cells 235 either extend away from the
first layer 210 (as shown in FIG. 21) or face the first layer
210.
[0115] In some additional embodiments, features of the first layer
210 and the third layer 214 of the tissue interface 114 may be
combined to a certain extent. For example, the third layer 214,
which ordinarily may be formed from two sheets of polymeric film,
may include the first layer 210 as one of the two sheets of
polymeric film. In such instances, the closed cells 235 of the
third layer 214 may be formed between, or encapsulated by, the
first layer 210 on a first side and a second sheet of polymeric
film on a second side. The fluid restrictions 220 of the first
layer 210 may be positioned between or around the closed cells
235.
[0116] Additional or alternative embodiments of the dressing 104
and, in particular, tissue interface 114 may be provided depending
on the particular application or tissue site presented. For
example, in some embodiments, one or more of the layers of the
tissue interface 114, such as the first layer 210, second layer
212, and third layer 214, may comprise an alternative material(s)
such as, for example, a closed-cell foam such as a ZOTEFOAM
material. A closed-cell foam material may be self-supporting, yet
also flexible, and may also permit open air pockets to be formed in
the material, rather than only closed-cell versions. Including
multiple layers of such a foam material may offer some benefits in
simplifying the construction of the tissue interface 114.
[0117] In some other example embodiments of the tissue interface
114, the third layer 214 may be provided with closed cells that may
be formed by printing a component across the surface of the third
layer 214 that may later expand and provide trapped air pockets.
For example, a polymer solution, suspension, or emulsion that
contains a blowing agent may be printed across a surface of the
third layer 214. Once the printed component on the third layer 214
is dry, heat may be applied to activate the blowing agent,
expanding the printed component. This method of forming the closed
cells may help simplify the lamination process of the various
layers of the tissue interface 114, by allowing multiple flat film
layers to be laminated and then the layers bonded together while
also expanded, in one heating process.
[0118] Depending on the particular embodiment of the tissue
interface 114, different mechanisms for bonding together the
various film layers of the tissue interface 114 may be used. For
example, the film layers of the tissue interface 114 may be formed
from film laminates, for example polyethylene/ionomer laminates,
where the ionomer is a low-melting point polymer that will soften
under low heat, thus, enabling the different film layers of the
tissue interface 114 to be bonded together. Therefore, in some
instances, the need for a separately-applied hot melt mesh may be
eliminated. Additionally or alternatively, the bonding surfaces of
the various film layers of the tissue interface 114 may be sprayed
with a pressure-sensitive or heat-reactive adhesive just prior to
lamination of the film layers. Furthermore, in embodiments where a
low-melting point hot-melt mesh is used to bond the various layers
of the tissue interface 114 together, the hot-melt mesh may be made
heat crosslinkable to provide additional heat stability.
Additionally, all of the various adhesives described above may be
made susceptible to crosslinking, for example by gamma irradiation,
in order to increase bond strength and improve heat stability.
[0119] The systems, apparatuses, and methods described herein may
provide significant advantages. For example, some embodiments of
the dressing 104 may provide a tissue dressing for use with
negative-pressure therapy that is simple to apply, and can reduce
the amount of time needed to apply and remove the dressing. Waste
associated with improper application of dressing materials can also
be reduced. In some embodiments, the tissue interface 114, and in
some instances the dressing 104, may be a fully-integrated
negative-pressure therapy dressing that can be readily cut, shaped,
and customized by an operator for application to a tissue site.
Unlike some instances of prior dressings, the tissue interface 114
or dressing 104 may be cut and shaped without exposing foam or
other materials which may allow in-growth of tissue and, thus, lead
to disruption of the tissue site during dressing removal. The
dressing 104 can provide good interaction with tissue at a tissue
site, including good manifolding of negative pressure and
therapeutic fluids provided in conjunction with instillation
therapy. For example, the inclusion of manifolding or spacing
layers, such as the second layer 212 and the third layer 214,
within the tissue interface 114 may provide good manifolding with a
compressible, soft material filler that can conform to spaces and
curves. Thus, the dressing 104 may offer beneficial granulation and
a low-trauma and high-seal bond with the tissue site, without
necessarily becoming incorporated with the tissue site as may occur
with prior dressings in the art.
[0120] Inclusion of different layers in the tissue interface 114
can provide a structure for filling deeper tissue sites, such as
medium-to-deep wounds, while substantially reducing or preventing
disruptive in-growth into the tissue interface 114 and dressing
104. These characteristics of the dressing 104 may be particularly
advantageous for placing within deep wounds or cavities of
undermined regions, while maintaining the ability of easy removal.
In some instances, the dressing 104 may provide a wound filler
which may safely remain in place at the tissue site for up to 7
days, or even longer. Furthermore, multiple layers of the dressing
104 may be formed from transparent materials, which may enable a
user to maintain a view of the tissue site for observing any color
or other aspects of the tissue site related to infection or other
conditions.
[0121] While shown in a few illustrative embodiments, a person
having ordinary skill in the art will recognize that the systems,
apparatuses, and methods described herein are susceptible to
various changes and modifications that fall within the scope of the
appended claims. Moreover, descriptions of various alternatives
using terms such as "or" do not require mutual exclusivity unless
clearly required by the context, and the indefinite articles "a" or
"an" do not limit the subject to a single instance unless clearly
required by the context. Components may be also be combined or
eliminated in various configurations for purposes of sale,
manufacture, assembly, or use. For example, in some configurations
the dressing 104, the container 106, or both may be eliminated or
separated from other components for manufacture or sale. In other
example configurations, the controller 108 may also be
manufactured, configured, assembled, or sold independently of other
components.
[0122] The appended claims set forth novel and inventive aspects of
the subject matter described above, but the claims may also
encompass additional subject matter not specifically recited in
detail. For example, certain features, elements, or aspects may be
omitted from the claims if not necessary to distinguish the novel
and inventive features from what is already known to a person
having ordinary skill in the art. Features, elements, and aspects
described in the context of some embodiments may also be omitted,
combined, or replaced by alternative features serving the same,
equivalent, or similar purpose without departing from the scope of
the invention defined by the appended claims.
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