Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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VACUUM THERAPY AND CLEANSING DRESSING FOR WOUNDS
This application is a divisional application of Application 2,689,308 which
itself is a divisional application of Canadian Application No. 2,467,837 filed
on
November 25, 2002.
BACKGROUND AND SUMMARY OF ME INVENTION
The present invention relates to bandages for wounds, and more
particularly to the provision of bandages for use with a vacuum source.
The prior art contemplates that chronic wounds may be treated by
providing a vacuum in the space above the wound to promote healing. A number
of
prior art references teach the value of the vacuum bandage or the provision of
th'e
vacuum in the space above the surface of a chronic wound.
A vacuum bandage is a bandage having a cover which seals about the
outer perimeter of the wound and under which a vacuum is established to act on
the
wound surface. This vacuum applied to the wound surface causes healing of
chronic
wounds. Typically, suction tubes are provided for drawing away exudate from
the
wound, and this suction may be used to create the vacuum under the cover. If
the
cover is a flexible cover, which is typically more comfortable for the
patient, some
sort of porous packing may be provided under the cover to provide the space in
which
the vacuum is formed. The following U.S. Patents establish the nature of
vacuum
treatment bandages and devices: 6,095,992, 6,080,189, 6,071,304, 5,645,081,
5,636,643, 5,358,494, 5,298,015, 4,969,880, 4,655,754, 4,569,674, 4,382,441,
and
' 4,112,947.
As shown, for example, in U.S. Patent No. 5,645,081 (hereinafter the
'081 patent), a method of treating tissue damage is provided by applying
negative
pressure to a wound. The negative pressure is provided in sufficient duration
and
magnitude to promote tissue migration in order to facilitate the closure of
the wound.
Fig. 1 of the '081 patent discloses an open cell polyester foam section
covering the
wound, a flexible hollow tube inserted into the foam section at one end and
attached
to a vacuum pump at another end, an adhesive sheet overlying the foam section
and
tubing to adhere to the skin surrounding the wound in order to form a seal
that allows
the creation of a vacuum when the suction pump is operating. The '081 patent
further
teaches use of negative pressure between about 0.1 and 0.99 atmospheres, and
that the
pressure can be substantially continuous, wherein the pressure is relieved
only to
change the dressing on the wound. Alternatively, the '081 patent teaches use
of a
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cyclic application of pressure in alternating periods of application and non-
application. In a preferred embodiment, pressure is applied in 5 minute
periods of
application and non-application.
Various other prior art references teach the value of the vacuum
bandage or the provision of vacuum to the surface of a chronic wound. Several
Russian language articles exist which establish the efficacy of vacuum therapy
discovered in the 1980's. Examples of such prior art articles, each of which
discusses
the use of application of vacuum to a wound to promote healing, are as
follows:
"Vacuum therapy in the treatment of acute suppurative diseases of soft tissues
and
suppurative wounds", Davydov, et al., Vestn, Khir., Sept. 1988 (the Sept. 1988
article); "Pathenogenic mechanism of the effect of vacuum therapy on the
course of
the wound process", Davydov, et al. Khirinigiia, June 1990 (the June 1990
article);
and "Vacuum therapy in the treatment of suppurative lactation mastitis",
Davydov, et
al. Vestn. Khir., Nov. 1986 (the Nov. 1986 article).
The Russian articles distinguish wound drainage from the use of
vacuum therapy for healing. The Russian authors report that vacuum therapy
resulted
in faster cleansing of the wound and more rapid detoxification than with the
traditional incision-drainage method. The November 1986 Russian article
describes
the vacuum therapy techniques as a reduction of 0.8-1 atmosphere for 20
minutes at
the time of surgery, and subsequent 1.5 to 3 hour treatments at a reduced
pressure of
0.1 to 0.15 from atmosphere, twice daily. These Russian articles teach the use
of
negative pressure to effect healing. The articles describe using several
sessions per
day, each lasting up to one hour, with a vacuum of 76-114 minHg. The Russian
articles teach using this vacuum method to decrease the number of microbes in
the
wound. The June 1990 article teaches that this vacuum therapy provides a
significant
antibacterial effect. The article describes the stepped up inflow of blood to
the zone
around the wound to lead to an increase in the number of leukocytes reaching
the
focus of inflamation. Subsequent articles and patents further develop the
benefits
obtained with vacuum therapy. The prior art, therefore, teaches the benefit
and value
of a vacuum bandage.
According to the present disclosure, a thin, flexible member for use in
a vacuum bandage is provided. The member includes a wound contacting surface
configured to be in contact with and conform to a wound surface of a wound.
The
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member further includes a plurality of discrete holes formed in the wound
contacting
surface, a port which communicates with the vacuum source, and communicating
means between the holes and the port. The member is made from a generally non-
compressible material. Further, the material is generally transparent and non-
porous.
In some illustrative embodiments, the communicating means
comprises a plurality of distinct passageways between each hole and the port.
The
member includes a wound contacting layer having channels formed therein and a
cover coupled to the wound contacting layer. The cover cooperates with the
wound
contacting layer, and the channels formed therein, to define the passageways.
The
member further includes a boss positioned near the port of the cover to
prevent an
upper surface of the wound contacting layer from sealing off the port of the
cover
when vacuum is applied to the port.
In some illustrative embodiments, the wound contacting surface of the
member includes spacers contacting the wound to defme a suction space between
the
member and the wound surface. The wound contacting surface may also be
textured
or roughened for contact with the wound surface. The unevenness of the
textured or
roughened surface provides communication of the negative pressure across the
wound
surface.
In some embodiments, the spacers and suction space are defined by a
plurality of channels formed in the wound contacting surface. Each of the
channels
formed in the wound contacting surface opens toward the wound surface and
includes
side edges contacting the wound.
In some embodiments of the invention, the dressing member has such
a plurality of channels formed in patterns on both of the wound contacting
surface and
the opposite surface and the plurality of holes provide communication between
the
channels on both surfaces. In some embodiments, the channel patterns on both
surfaces are congruent or superimposed with both patterns radiating outwardly
from
the port and with the holes spaced radially along the channels.
In some embodiments, the dressing member is made from a material
which is to be trimmed conformingly to fit the wound. In some embodiments, the
dressing member is relatively transparent such that the condition of the wound
surface
can be observed through the wound member.
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There is provided, therefore, a dressing for a wound, the dressing
comprising a relatively thin flexible member which can be trimmed conformingly
to
fit the wound surface. A suction and irrigation port is associated with the
dressing
member, and a plurality of channels or passageways is formed in the member
leading
away from the port to provide communication between the port and areas of the
wound surface. The dressing member is provided with a plurality of through
holes in
communication with the channels. A packing may be placed over the flexible
member and a sealing film may be placed over the packing to seal around the
perimeter of the wound to provide an enclosed space above the member in which
a
vacuum is formed by suction on the port. It will be appreciated, however, that
some
caregivers may choose to leave packing out of the bandage and have the sealing
film
placed directly over the flexible member. It has been found that some bandages
function quite well without packing. Also, visual observation is improved
without the
packing. Irrigation fluid may be introduced to the port to impinge upon the
wound
surface and this fluid and wound exudate is removed from the space between the
wound and the bandage member by suction applied to the port. It will be
appreciated
that the vacuum therapy and the irrigation therapy may take place without
removal of
the bandage. The illustrative member with the downwardly opening channels or
spacers on the wound contacting surfaces provides a suction space which will
uniformly apply the vacuum and the irrigation to the surface of the wound bed.
The covered channels on the opposite surface and the holes through the
member further contribute to the ability to unifounly apply the vacuum therapy
and
irrigation fluid to the wound surface. A relatively large portion of the wound
surface
will be exposed to the vacuum therapy and irrigation using the illustrative
bandage
member. A large number of redundant passageways are provided for communicating
from the access port directly to the wound surface. While some of the
passageways
may become blocked by exudate particles from the wound surface, other
passageways
will remain open for suction and irrigation.
The illustrative bandage, therefore, provides a relatively thin, flexible,
comfortable bandage member which can be trimmed generally conformingly to fit
into a wound bed and apply vacuum therapy and irrigation uniformly to the
wound
surface. The illustrative covered channel passageways on the opposite (upper
or
outer) surface provide a multitude of clearly defined passageways leading from
the
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access port to the through holes leading directly into the suction space under
the
member.
In further embodiments, the member includes a connecter coupled to
the cover for communication with the port of the cover. The connecter is
configured
for communication with the vacuum source and defines a right-angled passageway
to
provide a horizontal tube attachment.
In yet another embodiment, the member further includes an outer
adhesive perimeter. This perimeter is configured to seal about the wound to a
patient's healthy skin surrounding the wound. In another embodiment, the
member
further includes a wire form to permit a user or caregiver to mold or shape
the
member to fit the particular shape of a wound. In one embodiment, the wire
form is
molded into the cover and in another embodiment the wire form is molded into
the
wound contacting layer.
In still another embodiment, the member further includes a plurality of
irrigation passageways configured for communication with an irrigation source
and
with the wound surface. The irrigation passageways are distinct from the
passageways described above which are configured for communication with the
vacuum source. The member further includes an irrigation port in communication
with the irrigation passageways and configured for communication with the
irrigation
source. An irrigation layer is provided and includes channels formed therein
which
define the irrigation passageways.
A wound bandage for use on a chronic wound located on a patient's
heel is also disclosed. In this embodiment, the member is saddle-shaped and
includes
an upper portion, a lower portion, and a neck portion coupled to and
positioned
between the upper portion and the lower portion. The saddle-shaped member is
foldable into a configuration that cups the patient's heel. An embodiment
having a
member with a generally "V-shaped" cross-section is provided for use with
sternal or
abdominal wounds. The V-shaped member includes a right wing and a left wing
coupled to the right wing. Further, the V-shaped member includes a central
passageway in communication with the port of the cover and a plurality of
lateral
passageways in communication with the central passageway.
Another alternative member is disclosed for use with tunneled wounds.
This member includes a truncated cone-shaped portion, a tube-shaped portion
coupled
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to the cone-shaped portion, and a dome-shaped portion coupled to the tube-
shaped
portion. The port is positioned in the cone-shaped portion. Yet another member
is
disclosed which is dome-shaped and has a convex wound contacting surface.
A method of forming a member of a wound bandage is further
provided in accordance with the present disclosure. The method includes the
steps of
molding a cover from a semi-cured silicone and the step of heat-sealing the
cover to a
wound contacting layer. In illustrative embodiments, the method further
includes
providing a connecter and heat sealing the connecter to the cover. In further
embodiments, the method includes molding the connecter and the wound
contacting
layer from fully cured silicone.
Additionally, a method of treating an open wound having a wound
surface is provided in accordance with the present disclosure. The method
includes
the steps of providing a flexible member fabricated from non-porous material
to have
a wound contacting surface with holes in the surface, a port configured to
communicate with a vacuum source, and passageways providing communication
between the holes and the port. The method further includes placing the member
into
contact with the wound to functionally and physically interface with the wound
surface and connecting the port to a vacuum source to provide suction at each
of the
holes. In illustrative embodiments, the method further includes the step of
covering
the wound and the member adjacent the wound to provide a space in which a
vacuum
is established by the vacuum source. In other embodiments, the method includes
the
step of irrigating the wound surface by connecting the port to a source of
irrigation
fluid expelled through the holes onto the wound surface.
Another alternative member is provided including a single stand-off
coupled to the wound contacting or wound facing surface of the member. The
stand-
off includes a plurality of interconnected portions. Illustratively, the stand-
off forms a
spider-web-like design having a circle portion and a plurality of radial arms
extending
outwardly from the circle portion. Further illustratively, the stand-off
includes an arc
portion spaced-apart from and concentric with the circle portion. The radial
arms
extend through the arc portion. The cross-section of the stand-off is in the
shape of a
semi-circle having a radius of approximately 1.56 mm. The stand-off defines
encompassed regions of the wound facing surface of the member.
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Features of the invention will become apparent to those skilled in the
art upon consideration of the following detailed description of preferred
embodiments
exemplifying the best mode of carrying out the invention as presently
perceived.
BRIEF DESCRIPTION OF THE DRAWINGS
The detailed description particularly refers to the accompanying
figures in which:
Fig. 1 is a part perspective, part diagrammatic view of a wound care
bandage showing the wound care bandage located on the leg of a patient and
coupled
to both a vacuum and an irrigation source through the use of a switch valve;
Fig. 2 is a top view of a member of the wound care bandage showing
the member including a vacuum/irrigation port, a plurality of channels
radiating
outwardly from the port, and through holes which extend through the member;
Fig. 3 is an exploded view of one embodiment of the wound care
bandage showing the member having a wound contacting surface and an opposite
surface, a cover adjacent the opposite surface, tubing which connects to the
port of the
member at one end and to the vacuum and irrigation sources at another end,
packing
to be placed on top of the tubing and member, and a sealing film which closes
and
seals the bandage to allow a vacuum environment to be created;
Fig. 4 is a top view of a portion of the bandage showing the cover with
portions broken away and showing the member and the channels of the member
enclosed by the cover in order to form passageways extending away from the
port;
Fig. 5 is a sectional view taken along line 5-5 of Fig. 4 showing the
tube which may be sealed to the port, showing a shallow cone of the port, and
also
showing the channels of the opposite surface and channels of the wound
contacting
surface and the holes which communicate between the channels;
Fig. 6 is a top view of the portion of the member and cover shown in
Figs. 4 and 5 after having been trimmed to fit the particular wound of the
patient;
Fig. 7 is a sectional view of the bandage within the wound of the
patient showing the wound surface, the wound contacting surface of the member
adjacent the wound surface, the cover adjacent the opposite surface of the
member,
the tubing coupled to the port of the member, packing, and the outer film
coupled to
the patient's healthy skin to seal the environment;
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Fig. 8 is another embodiment showing an alternate wound contacting
surface of' the member including spacers for contacting the wound surface to
form an
open space between the member and the wound surface;
Fig. 9 is a sectional view taken along line 9-9 of Fig. 8 showing one
spacer and a through hole of the alternate member;
Fig. 10 is another embodiment showing an another wound contacting
surface of the member including spacers or oblong ridges provided to form an
open
space between the member and the wound surface when the member is placed in
the
wound;
Fig. 11 is a sectional view taken along line 11-11 of Fig. 10 showing
one oblong ridge and through hole of the alternate member;
Fig. 12 is another embodiment showing a wound care bandage having
two ports;
Fig. 13 is another embodiment showing an alternate opposite surface
of the member having ridges radially spaced around the port to provide a means
of
flow for exudate being vacuumed from the wound and/or for liquid being
dispensed to
the wound through the port;
Fig. 14 is a sectional view taken along line 14-14 of Fig. 13;
Fig. 15 is yet another embodiment showing a bandage having a
plurality of ports each coupled to a vacuum/irrigation tube to provide an
evenly
distributed suction force across the member;
Fig. 16 is another embodiment showing a member of the bandage
having a central aperture at the port of the member and channels extending
radially
outwardly from the central aperture;
Fig. 17. is an exploded perspective view of another wound care
bandage similar to the wound care bandage of Fig. 1 showing the bandage
positioned
above a wound bed and including a wound contacting layer and a cover of the
bandage which cooperate to form a wound dressing member for placement within
the
wound bed, and also showing sealing film to cover the member and seal about
the
wound;
Fig. 18 is a sectional view of the member of Fig. 17 showing the non-
porous nature of the member and also showing distinct passageways and through
holes of the member;
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Fig. 19 is a sectional view similar to Fig. 18 showing rounded
protrusions or bosses of the wound contacting layer adjacent to the cover and
positioned about a port of the cover;
Fig. 20 is a bottom perspective view of the member showing a smooth
wound contacting surface of the member and also showing the transparent nature
of
the member;
Fig. 21 is a bottom view of a portion of a member having a rough or
textured wound contacting surface;
Fig. 22 is a sectional view taken along line 22-22 of Fig. 21 showing
the irregular texturing of the wound contacting surface of the member;
Fig. 23 is a top view of a member showing the member being saddle-
shaped for use on a heel, as shown in Fig. 25, for example, and also showing a
centrally located connecter coupled to the cover and in communication with a
central
port of the cover and channels of the wound contacting layer radiating
outwardly from
the port;
Fig. 24 is a top view of another member, similar to the embodiment of
Fig. 23, showing the member being saddle-shaped, a port positioned on an upper
portion of the member, and lateral passageways of the member extending
outwardly
and downwardly from a vertical central passageway of the member;
Fig. 25 is a perspective view of the member shown in Fig. 24
positioned around the heel of a patient's foot;
Fig. 26 is a perspective view of another embodiment of the member
showing the member having a truncated cone-shaped portion coupled to a tube-
shaped portion for use with tunneled wounds, as shown in Fig. 27;
Fig. 27 is a sectional view of the member shown in Fig. 26 showing
the member positioned within the tunneled wound of a patient;
Fig. 28 is a top view of a "V-shaped" member for use with sternal or
abdominal wounds, for example;
Fig. 29 is a perspective view of the V-shaped member of Fig. 28
showing the member on the sternal wound of a patient;
Fig. 30 is a sectional view taken along line 30-30 of Fig. 29 showing
the V-shape of the member and also showing the wound contacting surface of the
member adjacent the sternal wound surface;
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Fig. 31 is a perspective view of yet another embodiment of the member
of the present invention showing the member being dome-shaped and having a
convex wound contacting surface;
Fig. 32 is a perspective view of another embodiment of the bandage
showing a vertical tube attachment at the port of the member;
Fig. 33 is an exploded perspective view of another embodiment of the
member showing a cover of the member having channels formed therein and also
showing a wound contacting layer of the member having a smooth surface and
thru
holes for communication with the channels of the cover;
Fig. 34 is a sectional view of a portion of the member of Fig. 33;
Fig. 35 is an exploded perspective view of another member showing
the member including a cover, a wound contacting irrigation layer, and an
intermediate layer positioned between the cover and the irrigation layer;
Fig. 36 is a sectional view of the member of Fig. 35 showing the
irrigation layer in communication with an irrigation source (illustrated
diagrammatically) and showing the cover in communication with a vacuum source
(illustrated diagrammatically) to provide the member with the capability to
simultaneously apply vacuum and irrigate the wound;
Fig. 37 is a bottom view of a cover showing a filament or wire form
molded into the cover to allow the member to retain a desired shape when
shaped or
formed by a user or caregiver to fit a particular wound, for example;
Fig. 38 is a sectional view of a member including the cover and wire
form shown in Fig. 37;
Fig. 39 is a bottom view of another member showing the wound
contacting layer having an adhesive outer perimeter for sealing about the
wound in
order to provide a self-sealing member, as shown in Fig. 40;
Fig. 40 is a sectional view of the member of Fig. 39 showing the outer
adhesive perimeter of the wound contacting layer coupled to the patient's
healthy skin
surrounding the wound in order to seal the member about the wound without the
use
of the sealing film shown in Fig. 17;
Fig. 41 is a top view of the member of the present invention showing
the cover of the member including scale markings to provide a caregiver with a
reference point for trimming the member to fit the particular wound of the
patient;
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Fig. 42 is a perspective view of another member of the present
invention showing a wound contacting layer, a cover, and a connector coupled
to the
cover of the member and also showing the connector having a single, angled
passageway;
Fig. 43 is a bottom perspective view of the wound contacting layer of
the member of Fig. 42 showing a single stand-off coupled to the wound
contacting
surface of the layer and generally forming a spider-web-like pattern having
radially
extending portions and concentric circular portions; and
Fig. 44 is a sectional view showing the angled connector of the
member of Figs. 42 and 43 coupled to a multi-lumen tube by a barbed tube
coupler.
DETAILED DESCRIPTION OF THE DRAWINGS
A wound care bandage 10 is provided for use with a vacuum and
irrigation source 12, 14, respectively, as shown in Fig. 1. An illustrative
vacuum and
irrigation source 12, 14 is disclosed in U.S. Publication No. US-2002-0161317-
Al
published October 31, 2002, and U.S. Patent No. 6458109 issued October 1,
2002.
Bandage 10 promotes the healing of a large wound 16 (shown in Figs.
3 and 7) by providing vacuum therapy to the wound 16 to promote blood flow and
remove exudate from a wound surface 18 of the wound 16 and by providing for
irrigation of the wound 16 with fluids such as saline, for example.
As shown in Fig. 3, wound care bandage 10 comprises a thin, flexible
wound dressing member 20, shown in Fig. 2. Member 20 is made of a medical
grade
silicone or other type of elastomer which is pliable. Two companies, for
example,
which manufacture such medical grade silicone are GE Silicones and NuSil
Technology. It is within the scope of this disclosure, however, to include a
wound
dressing member made of any type of thin, flexible material that is non-porous
and
non-foam-like. This thin, flexible material is also generally non-absorptive.
For
example, materials such as polyvinylchloride (PVC), PVC free of diethylhexyl
phthalate (DEBT-free PVC), polyurethane, or polyethylene may be used in the
manufacture of member 20.
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Further, member 20 may be molded to include anti-microbial
constituents. For example, it is within the scope of this disclosure to
impregnate
member 20 with silver ions which are known anti-microbials. The following PCT
publications illustrate the use of anti-microbials in various products:
"Antimicrobial Plastic Closures for Drinking Containers", WO 00/26100;
"Antimicrobial Contact Lens Case", WO 00/38552; "Antimicrobial Fabric
and Medical Graft of the Fabric", WO 00/32247; "Antimicrobial Suturing
Ring for Heart Valve", WO 00/30567.
Member 20 is also made of a generally non-adhesive material.
Therefore, wound contacting layer 22, which lies adjacent to the wound surface
18,
does not adhere to the wound surface 18. Further, member 20 is solid in nature
and
generally non-compressible. For example, when a negative pressure is applied
to
member 20, a thickness, t, of member 20, as shown in Fig. 3, remains
relatively
constant.
As shown in Fig. 2, wound dressing member 20 is illustratively
rectangular in shape. However, it is within the scope of the this disclosure
for
member 20 to be any suitable shape, some illustrative examples of which are
described below in Figs. 23-31. Further, member 20 may be cut to fit any size
wound
16, as shown in Figs. 4 and 6. Member 20 is illustratively molded with a
thickness of
0.080 inch (2.032 mm). Illustratively, member 20 is made from a silicone of a
Durometer 10A which is flexible. It will be appreciated that the channels or
passageways formed in the member, as described below, will further contribute
to its
flexibility.
Member 20 includes a wound contacting surface 22 and an opposite
surface 24. Wound contacting surface 22 or portions thereof contact the wound
surface 18 as shown in Fig. 7. Looking to Fig. 2, it can be seen that opposite
surface
24 includes a central area defining a vacuum/irrigation port 26. A plurality
of
channels 28 are formed in opposite surface 24 and extend radially away from
central
area or port 26. Illustratively, each channel 28 is 0.030 inch (0.762 mm) wide
and
0.030 inch (0.762 mm) deep. It is within the scope of this disclosure,
however, to
include channels 28 of member 20 having various widths and depths suitable for
the
present application. Port 26, as shown in Fig. 5, includes a shallow cone 64
in order
to induce fluids dispensed through a vacuum/irrigation tube 13 from the vacuum
and
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irrigation sources 12, 14 to flow evenly into channels 28. In an alternate
embodiment
shown in Fig. 16, an alternate port 86 includes an aperture 88 formed through
member
20. In the Fig. 16 embodiment, the port communicates directly with the
suction/irrigation space between the member 20 and the surface of the wound.
Vacuum/irrigation tube 13 is in communication with central area or
port 26 of member 20 via a port 51 of a cover 52 (described below) of the
bandage 10.
coupled to the port. The tube 13 may be molded as part of the member 20 or
attached
to the member by welding, adhesion or other known techniques. The tube is
preferably made of silicone, however, it is within the scope of this
disclosure to
include a vacuum/irrigation tube made of other medically suited materials.
Opposite
surface 24 further includes channels 30 which are concentric with port 26,
as.shown
in Fig. 2. Concentric channels 30 have the same width and depth as that of
channels
28 described above.
Wound contacting surface 22 includes a plurality of channels 32 which
radiate outwardly from the center of member 20 similar to channels 28 of
opposite
surface 24. Similarly, wound contacting surface 22 also includes a plurality
of
channels 34 concentric with the center of member 20. Each channel 32, 34 of
wound
contacting surface 22 opens toward the wound surface 18 and includes outer
edges 42
which contact the wound surface 18 or which act as spacers to provide space
between
the member 20 and the wound surface. Illustratively, the channels 32,34 of
wound
contacting surface 22 have the same dimensions as the channels 28, 30 of
opposite
surface 24. In other words, illustratively channels 32, 34 of wound contacting
surface
22 are 0.030 inch (0.762 mm) deep and 0.030 inch (0.762 ram) wide. However, it
is
within the scope of this disclosure to include channels 32, 34 of surface 22
having
other widths and depths.
Through holes 36 are provided in member 20 for communication
between the channels 28, 30 of the opposite surface 24 with the channels 32,
34 of the
wound contacting surface 22. As shown in Fig. 2, holes 36 are illustratively
positioned to lie within concentric channels 30, 34 of each respective surface
22, 24
of member 20. Holes 36 are illustratively 0.030 inch (0.762 nun) in diameter
and are
illustratively spaced approximately 0.500 inch (12.700 mm) apart along
channels 28,
30, and 32, 34 of each respective surface 22, 24. Member 20 is provided in
small,
medium, and large sizes. The small sized member has a length of 3.00 inches
(76.20
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mm) and a width of 4.00 inches (101.60 mm); the medium sized member has a
length
of 4.00 inches (101.60 mm) and a width of 6.00 inches (152.40 mm); the large
sized
member has a length of 6.00 inches (152.40 mm) and a width of 10.00 inches
(254.00
mm). The holes of the small and medium sized members 20 are 0.030 inch (0.762
mm) in diameter. The large sized member, however, includes some holes having a
diameter of 0.030 inch (0.762 mm) and other holes having a diameter of 0.040
inch
(1.016 mm). It is, however, within the scope of the disclosure to include
members of
other suitable shapes and sizes including holes having other suitable size
diameters
and other spacing as well.
Channels 32, 34 of wound contacting surface 22 provide open spaces
40 between the wound surface 18 and member 20, as shown in Fig. 7. Open spaces
40 are defined by each channel 32, 34 of wound contacting surface 22, each
outer
edge 42 of channels 32, 34, and wound surface 18. Each through hole 36 of
member
20 opens into the open spaces 40 formed by channels 32, 34. Open spaces 40
allow
vacuum source 12 to establish a generally uniformly distributed vacuum therapy
to
draw exudate from the wound 16 into the channels 32, 34 of wound contacting
surface 22.
It is within the scope of this disclosure to provide spacers 46, for
example, shown in Figs. 8 and 9. Spacers 46 protrude outwardly from wound
contacting surface 22 to contact wound surface 18. Open spaces 40 are provided
between spacers 46. As shown in Fig. 9, each spacer 46 has an illustrative
depth of
approximately 0.030 inch (0.762 mm). However it is within the scope of this
disclosure to include spacers having other suitable dimensions which provide
open
spaces 40. As with member 20 including channels 32, 34 on wound contacting
surface 22, holes 36 of member 20 including spacers 46 are positioned to open
into
the open spaces 40.
Further, it is within the scope of this disclosure to include member 20
having other types of spacers on wound contacting surface 22 which create open
spaces 40 when wound contacting surface 22 is adjacent the wound surface 18.
In
another embodiment, as shown in Figs. 10 and 11, oblong ridges 50 are provided
on
wound contacting surface 22. Ridges 50 are similar in shape and function to
spacers
46. Ridges 50 protrude away from member 20 and contact wound surface 18 when
member 20 is place on wound surface 18 to provide open spaces 40 between wound
CA 02813265 2013-04-08
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surface 18 and member 20 to establish a generally uniform vacuum across the
wound
surface 18. As shown in Fig. 11, each ridge 50 illustratively has a preferred
depth of
0.030 inch (0.762 ram), however, a ridge having other suitable dimensions is
within
the scope of this disclosure. As illustrated by channels 32, 34 of wound
contacting
surface 22, spacers 46, or ridges 50, it is within this disclosure to include
other
structures which acts as spacers to create open spaces 40 between the wound
surface
18 and member 20 when member 20 is placed on the wound surface 18 to
distribute
suction and irrigation generally uniformly throughout the wound 16. For
example,
the wound contacting surface maybe textured or roughened as illustrated by
irregular
nubs 74 in Figs. 21 and 22. This textured surface is described in more detail
below
with respect to a bandage 11 shown in Fig. 17.
As mentioned above, bandage 10 further comprises cover 52 for
covering and coupling to opposite surface 24 of member 20. Port 51 of cover 52
communicates with central area or port 26 of member 20 and channels 28 of
member
20. Cover 52 is provided to cover channels 28, 30 of opposite surface 24.
Cover 52
and channels 28 of opposite surface 24 cooperate to form passageways 56, as
shown
in Fig. 7, extending away from port 26. Passageways 56 are also formed by the
cooperation of concentric channels 30 of opposite surface 24 and cover 52.
Cover 52
is adhered to member 20 through the use of an adhesive or other suitable means
such
as heat sealing, for example, which is described in more detail below. It will
be
appreciated that the covered channels 28, 30 provide an ideal way to fabricate
a
multitude of passageways 56 communicating with the wound surface. In an
alternate
embodiment, passageways 56 are formed by cooperation of ridges 54 on opposite
surface 24 of member 20, rather than channels 30, and cover 52, as shown in
Figs. 13
and 14, for example. It is within the scope of this disclosure to include a
bandage 10
forming other passageways 56 extending away from port 26. Holes 36 of member
20
having ridges 54 are located within passageways 56 of bandage 10 similar to
holes 36
of member 20 having radial channels 28 and concentric channels 30.
It will be appreciated that the illustrative cover 52 may be provided
with scale marking for gauging the wound size or healing progress. Circular
markings may be added at 0.5 cm or 1.0 cm intervals, for example, to provide
convenient measuring of the wound and healing progress.
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As shown in Figs. 3 and 7, bandage 10 further includes gauze or other
suitable packing 58 which lies on top of cover 52 and is provided to fill the
wound 16
up to the surface of the patient's healthy skin 60. As noted above, such
packing 58
may be optional with the caregiver. A sealing film 62 of bandage 10 is placed
over
packing 58. Film 62 is provided to cover the entire wound 16 and to extend
across
and attach around tube 13 to the patient's healthy skin 60, as shown in Figs.
1 and 7.
Preferably, film 62 is an occlusive or semi-occlusive material which allows
water
vapor to permeate through. Because of this characteristic, the film 62 is
referred to as
Moisture Vapor Transmission Rate film or MVTR film. The products TegadermTm,
made by 3M, and OpSiteTm made by Smith and Nephew can be used for film 62, for
example. The product OpSiteTm is a semi-permeable film. Film 62 is
approximately
0.003 inch (0.076 mm) thick, however, it is within the scope of this
disclosure to
include any occlusive or semi-occlusive film 62 having other thickness. Film
62 is
provided to create a sealed environment below the film 62 and around the wound
16
in which a vacuum or negative pressure can be maintained as provided by vacuum
source 12.
As shown in Fig. 7, vacuum/irrigation tube 13 or an extension added to
the tube 13 extends over the edge of member 20 and cover 52 and out from under
the
edge of the sealing film 62. In use, irrigation source 14 delivers liquid
through tube
13 and port 51 of cover 52 to port 26 and onto the top of a shallow cone 64 of
member 20 which extends upwardly as shown in Figs. 5 and 7. Cone 64 acts to
spread the liquid out through the passageways 56 formed by the cooperation of
channels 28, 30 (or ridges 54) and cover 52. The fluid moves radially out
through
passageways 56 to holes 36. The fluid then moved down through holes 36 to open
spaces 40 to impinge on wound surface 18.
A switch valve 66 is illustratively provided, as shown in Fig. 1, to
allow a user to switch between the use of the vacuum source 12 and the
irrigation
source 14. It will be appreciated that mechanism other than the switch valve
66 may
be used selectively to couple the vacuum source or the irrigation source to
the
bandage. Simple tube clamps, for example, may be used selectively to open and
close
the tube set provided with the bandage 10. When valve 66 is switched to
operate the
vacuum source 12, the vacuum suction draws exudate into the open spaces 40 and
up
CA 02813265 2013-04-08
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through the holes 36. The exudate is then drawn radially inwardly through
passageways 56 toward port 26 and fmally through tube 13.
Although illustrative bandage 10 includes one central port 51 of cover
52 and central area or port 26 of member 20, it is within the scope of this
disclosure to
include multiple ports 70, as shown in Figs. 12 and 15, for example. Bandage
10 may
make use of two ports 70 located at opposite ends of member 20, as shown in
Fig. 12.
Alternately, as shown in Fig. 15, bandage 10 may make use of a plurality of
ports 70
spaced throughout member 20. It is contemplated that, in some embodiments
having
two ports, one port may be used for suction or vacuum therapy and the other
port may
be used for irrigation therapy.
It is contemplated that irrigation source 14 may be operated to provide
irrigation fluid at various selected pressures. It is also contemplated that
the bandage
and dressing member 20 may be provided in various sizes and shapes, some
examples of which are shown in Figs. 23-31 and are discussed below. The
dressing
member 20 may be reused with a single patient. It is also contemplated that
the
dressing 10 may be used with manual irrigation (where a nurse uses the syringe
manually) as well as the powered syringe 14.
Referring now to Figs. 17-22, there is shown another exemplary
embodiment of a wound care bandage 11. Bandage 11 is somewhat similar to
bandage 10. As such, the same reference numerals have been used to designate
similar components to those components previously discussed in regard to Figs.
1-7,
and additional discussion thereof is not warranted. One difference between
bandage
10 and bandage 11 is that a wound dressing member 19 of Figs. 17-22 is defined
as
including the combination of a wound contacting layer 80, similar to member 20
of
Figs. 1-7, cover 52 coupled to layer 80, and a connecter 23 coupled to cover
52 for
communication with vacuum source 12 and/or irrigation source 14. It is also
within
the scope of this disclosure for connecter 23 to be integrally coupled to
cover 52.
Similar to member 20, member 19 is thin and flexible. Layer 80,
cover 52, and connecter 23 are each made of a medical grade silicone or other
type of
pliable elastomer as described above with respect to member 20. Member 19 is
similarly non-porous, non-foam-like, and generally non-absorptive. Materials
such as
PVC, DEHP-free PVC, polyurethane, or polyethylene may similarly be used in the
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manufacture of member 19. Further, layer 80, cover 52, and connecter 23 of
member
19 may each be molded to include anti-microbial constituents similar to member
20.
Also similar to member 20, member 19 is made of a generally non-
adhesive material to prevent wound contacting layer 80, which lies adjacent to
the
wound surface 18, from adhering to the wound surface 18. Further, member 19 is
similarly solid in nature and generally non-compressible. For example, when a
negative pressure is applied to member 19, a thickness t', of member 19, as
shown in
Figs. 18 and 19, remains relatively constant. Thickness, t', represents solid
areas of
member 19 where a channel or passageway is not present. Member 19 is generally
pliable and flexible, but is not generally compressible. Further, as shown in
Fig. 20,
member 19 (like member 20) is transparent to enable a caregiver to be able to
see the
wound 16 through member 19 when member 19 is placed adjacent to wound surface
18. This transparency allows the caregiver to view the progress of the healing
of the
wound 16.
Layer 80 includes a wound contacting surface 84 and an upper or
opposite surface 85. Wound contacting surface 84, or portions thereof contacts
and
generally conforms to the wound surface 18. Opposite surface 85 includes a
central
area 87 and the same plurality of channels 28, shown previously in Figs. 2-4
with
respect to member 20. Channels 28 extend radially away from central area 87.
Central area 87 is similar to central area or port 26 of a member 20 in that
central area
87 communicates with port 51 of cover 52. However, central area 87 is recessed
relative to the portions of upper surface 84 between channels 28, as shown in
Figs. 18
and 19. As shown in Figs. 17 and 20, channels 28 are open at the sides and
ends of
member 19, similar to channels 28 of member 20. Opposite surface 85 further
includes concentric channels 30, shown in Figs. 17, 20 and 21. As shown in
Fig. 17,
central area 87 of layer 80 is provided to communicate with the vacuum source
12 and
irrigation source 14 through cover 52, as will be described below.
A plurality of radially extending protrusions or bosses 90 are
positioned around central area 87. Bosses 90 are positioned between central
area. 87
and channels 28, 30, as shown in Fig. 17. Bosses 90 prevent central area 87
from
collapsing in on port 51 of cover 52 and forming an unwanted seal which would
effectively block air flow through port 51 while suction is applied to bandage
11.
Port 51 communicates with the vacuum source 12 and/or the irrigation source 14
via
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connecter 23 and tube 13, as shown in Figs. 17-20. As mentioned above, port 51
is in
communication with central area 87 of layer 80.
Illustratively, four bosses 90 are shown in Fig. 17. However, it is
within the scope of this disclosure to provide any number of bosses 90,
including
eight bosses, or the like about central area 87 of layer 80 to prevent central
area 87
from sealing off port 51 of cover 52 as suction is applied to bandage 11.
Further, it is
within the scope of this disclosure to include bosses 90 having a tapered
cross-section,
as shown in Fig. 19, or to include a boss or bosses having any shape that
prevents
central area 87 from sealing off port 51 when suction is applied to bandage
11.
Alternative or supplemental bosses 91 are shown in Fig. 19. Bosses 91 are
positioned
between bosses 90 and further prevent central area 87 from collapsing on port
51 and
forming an unwanted seal blocking air flow through port 51 while suction is
applied
to bandage 11. Alternative bosses 91 are generally rectangularly shaped and
extend
inwardly from channels 28 toward central area 87.
Connecter 23, as shown in Figs. 17-19, is a tubal port coupled to a top
surface 53 of cover 52 and in communication with port 51 of cover 52. As
mentioned
before, it is within the scope of this disclosure for connecter 23 to be a
separate
component of member 19 which is coupled to cover 52 or for connecter 23 to be
molded integrally with cover 52. Connecter 23 includes a passageway formed at
a
right-angle. Thus, the passageway in connecter 23 has a vertical portion 25
that
communicates with port 51 and a horizontal portion 27 that communicates with
vertical portion 25. Connecter 23 connects with tube 13 to provide a
horizontal tube
attachment with respect to port 51. A vertical tube attachment is shown in
Fig. 32, for
example. In Fig. 32, tube 13 is coupled directly to port 51 of cover 52. Cover
52
includes a bottom surface 55 and top surface 53, as shown in Fig. 17. Bottom
surface
55 engages opposite surface 85 of layer 80, as shown in Figs. 18-20.
In some embodiments, member 19 is made by heat sealing opposite
surface 85 of layer 80 and bottom surface 55 of cover 52 together and by heat
sealing
connecter 23 to top surface 53 of cover 52. Member 20 of bandage 10 may also
be
heat sealed to cover 52. With respect to member 19 of bandage 11, for example,
each of connecter 23, cover 52 (or the combination of cover 52 and connecter
23), and
layer 80 may be pre-shaped and formed from semi-cured silicone. Once the
connecter 23, cover 52, and layer 80 are placed together appropriately, the
entire
CA 02813265 2013-04-08
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member 19 may be heated to heat seal and cure each of the three components to
one
another. Alternatively, for example, the cover 52 only may be made from semi-
cured
silicone while the connecter 23 and layer 80 may be made from fully cured
silicone.
Once placed together and heated, connecter 23 and layer 80 will heat seal to
cover 52.
Semi-cured silicon may be bought and pre-molded from a manufacturer such as
NuSil
Technology, for example. Although the method of heat sealing the cover 52,
connecter 23, and layer 80 to each other is disclosed, it is within the scope
of this
disclosure to form member 19 by coupling layer 80, cover 52, and port 51
together by
any other means such as through the use of adhesives, for example. Further, it
is
within the scope of this disclosure to provide a member 19 where cover 52 lies
adjacent to, but is not coupled to, layer 80.
As mentioned above, cover 52 is coupled to layer 80 and connecter 23
is coupled to cover 52 to form member 19. Cover 52 and layer 80 cooperate to
form
distinct passageways 56 of member 19 defined by channels 28, 30 of layer 80
and
bottom surface 55 of cover 52. Passageways 56 are in communication with
central
area 87 of layer 80 and central area 87 of layer 80 is in communication with
port 51 of
cover 52 which is in communication with the vacuum and/or irrigation sources
12, 14
via connecter 23 and tube 13. Therefore, pasiageways 56 are in communication
with
the vacuum and/or irrigation sources 12, 14.
Layer 80 (similar to member 20) includes through holes 36 which
extend from channels 28, 30 through layer 80 to wound contacting surface 84,
as
shown in Figs. 18 and 19. Holes 36 are distinct and are provided to
communicate
with channels 28, 30 of layer 80. Holes 36 therefore communicate with
passageways
56 of member 19 and the vacuum and/or irrigation sources 12, 14 as well to
allow the
suction from the vacuum source 12 and/or the fluid from the irrigation source
14 to
reach the wound surface 18 via the holes 36. As shown in Figs. 2,20, and 21,
holes
36 have a staggered arrangement. Illustratively, holes 36 are 0.030 inch
(0.762 mm)
in diameter and are spaced approximately 0.500 inch (12.700 mm) apart along
channels 28,30 of layer 20. As mentioned before, however, it is within the
scope of
the disclosure to include holes having other suitable sized diameters and/or
other
suitable spacing that allow for the removal of exudate without clogging. For
example,
the small and medium sized bandages, as described above, each include holes
having
a diameter of 0.030 inch (0.762 mm) while the large sized bandage includes
some
CA 02813265 2013-04-08
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holes having a diameter of 0.030 inch (0.762 mm) and other holes having a
diameter
of 0.040 inch (1.016 mm). Bandage 11 further includes sealing layer or film 62
that is
placed over cover 52 and around tube 13, as shown in Figs. 1 and 17 and
described
above with respect to bandage 10. Film 62 may be substantially larger than the
wound 16 or member 19 to provide an effective seal about the member 19 and the
wound 16. Bandage 11 does not include gauze or packing 58 included in bandage
10.
Illustrative member 19 of bandage 11 includes a smooth wound
contacting surface 84, as shown in Fig. 17. Wound contacting surface 84 may
also be
textured or roughened as illustrated by irregular nubs 74 shown in Figs. 21
and 22.
Nubs 74 may have different dimensions as shown by thickness, ti, and
thickness, t2,
in Fig. 22. By providing member 19 with a textured or roughened surface, a
space is
created between surface 84 of layer 80 and wound surface 18. Through holes 36
communicate with this space which permits vacuum source 12 to establish a
generally
uniformly distributed vacuum or negative pressure to the wound surface 18 to
draw
blood from the body to the wound surface 18 and to draw exudate from the wound
16
through holes 36, into channels 28, 30 and passageways 56, and out port 51 of
cover
52. It is within the scope of this disclosure to include other means for
providing a
space between surface 84 and wound bed surface 18 such as providing ribs,
protrusions, channels, spacers, etc, as described above with respect to member
20 of
bandage 10.
The vacuum or negative pressure which draws blood from the body to
the wound surface 18 and draws exudate from the wound 16 up through member 19
promotes the healing of wound 16. As wound 16 heals, granulations form along
the
wound surface 18. Granulations, therefore, are the replacement within the
wound bed
of tissue lost. As the granulations fill in the wound bed causing the wound 16
to heal,
member 19 rides up on the wound surface 18 on top of the granulations which
are
formed.
Although illustrative bandage 10 includes one central port 40, it is
within the scope of this disclosure to include multiple ports. It is further
within the
scope of this disclosure to provide an illustrative member 619, as shown in
Figs. 35
and 36 and discussed below, having multiple ports and multiple passageway sets
for
use independent of each other.
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In order to accommodate different sized wounds 16, member 19 may
be trimmed to fit a particular wound 16. As shown in Fig. 41, some embodiments
of
member 19 include scale markings 76, indicated by the dotted lines. Scale
markings
76 indicate areas where a caregiver may trim member 19 to fit a particular
wound 16.
Further, the scale markings 76 may denote measurement sizes, for example, to
permit
a caregiver to cut the member 19 to fit a pre-measured wound 16. Also, as
mentioned
above, the transparent nature of member 19 is illustrated in Fig. 41.
In order to accommodate various types and placements of wounds on
patients, member 19 may be provided in various conforming shapes and sizes.
For
example, illustrative embodiments of a member 119 are shown in Figs. 23-25 for
use
with a wound on a patient's heel 117. Member 119 is saddle-shaped and includes
a
top portion 150, a bottom portion 152, and a neck portion 154 integrally
coupled to
and spaced between top portion 150 and bottom portion 152, as shown in Figs.
23 and
24. Member 119 includes a right and a left side 156, 158 which are each shaped
to
form an inwardly facing "W". Each W-shaped side 156, 158 includes a top point
160,
a first trough 162, a peak 164, a second trough 166, and a bottom point 168.
The neck
portion 154 is positioned between each of the peaks 164.
Member 119 is similar to member 19 and includes a cover (not shown)
and a wound contacting layer (not shown) having channels 28, 30 and through
holes
36. To form member 119, the cover and layer are each saddle-shaped and include
matching W-shaped sides. The cover and layer cooperate to form passageways 56
of
member 119 in a manner similar to the manner in which cover 52 and layer 80
(and
cover 52 and member 20) cooperate to form passageways 56 in member 19. All
similar features between member 19 and alternate member 119 are marked with
similar reference numerals. The cover of member 119 includes port 51 formed in
top
surface 53 of the cover and in communication with connecter 23.
Port 51 and connecter 23 are centrally located and passageways 56
radiate outwardly therefrom in the embodiment of Fig. 23. Illustratively, port
51 and
connecter 23 are located on top portion 150 of member 119, the embodiment
shown
in Fig. 24. Passageways 56 of member 119 shown in Fig. 24 are defined by a
central
passageway 141 in communication with port 51 of the cover and lateral
passageways
142 in communication with central passageway 141. The passageways 56 in the
embodiment of Fig. 24 terminate before reaching the peripheral edge of member
119,
CA 02813265 2013-04-08
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whereas passageways 56 in the embodiment of Fig. 23 are open at the peripheral
edge. As shown in Fig. 25, member 119 is folded to cup the patent's heel 117.
In the
illustrative cupped configuration of member 119, troughs 162 of top portion
150
=
overlap troughs 166 of bottom portion 152.
A member 219 is illustratively shown in Figs. 26 and 27 and is used to
treat tunneled wounds such as wound 116. Member 219 includes a truncated cone-
shaped portion 250 and a tube-shaped portion 252 coupled to cone-shaped
portion
250 at a first end 254. A dome-shaped tip 256 is coupled to tube-shaped
portion 252
at a second end 258 of the tube-shaped portion 252.
Member 219 is similar to members 119 and 19 in that member 219
includes a wound contacting layer 220 coupled to a cover 222. Further, wound
contacting layer 220 and cover 222 cooperate to form passageways 56 which
communicate with port 51 of cover 222 and connecter 23. Wound contacting layer
.
220 is formed to define through holes 36 which communicate with the
passageways
56 of member 219 and with wound bed surface 18 of tunneled wound 116.
Member 219 operates in the same or similar manner as members 119
and 19 in that connecter 23 may be coupled to a vacuum source 12 for
establishing a
vacuum about the wound bed surface 18 to draw blood up to the wound bed
surface
18 and/or to remove exudate from the wound bed surface 18. Connecter 23 may
also
be coupled to irrigation source 14 to supply fluids such as saline, for
example, to the
wound bed surface 18. As shown in Figs. 26 and 27, port 51 and connecter 23 of
member 219 are positioned on the cone-shaped portion 250. However, it is
within the
disclosure to position port 51 and connecter 23 anywhere on member 219.
Another illustrative member 319 is shown in Figs. 28-30. Member 319
is provided for use with abdominal or sternal wounds 316. Fig. 29 shows member
319 being used to treat a sternal wound 316. As shown in Figs. 29 and 30,
member
319 is generally "V-shaped" and includes a right wing 350 and a left wing 352.
Member 319 further includes a central portion 351 having a central passageway
354
and a port 340 coupled to tube 41 for communication with either vacuum source
12 or
irrigation source 14. Right and left wings 350, 352 are each coupled to
central portion
351. Lateral passageways 356 are formed by the cooperation of a wound
contacting
layer 320 and a cover 322 of member 319, as shown in Fig. 11. Lateral
passageways
356 terminate before reaching the sides or peripheral edges of member 319.
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However, central passageway 354 is open at both a top and bottom edge of
member
19. Through holes 36 are formed in wound contacting layer 320 and are provided
for
communication between passageways 354 and the wound surface 18. Although the
communication between the wound surface 18 and the vacuum source 12 and/or
irrigation source 14 is provided through central and lateral passageways 354,
356, as
shown in Fig. 28, it is within the scope of this disclosure to provide_a
member 319 for
use with abdominal and/or sternal wounds having a different passageway
structure for
communicating the vacuum source 12 with the wound surface 18. Further,
although
member 319 is V-shaped, it is within the scope of this disclosure to include a
generally fiat member which is flexible to adjust to the contour of the
sternal or
abdominal wound to which it is applied.
Yet another illustrative embodiment is shown in Fig. 31 where a
generally dome-shaped member 419 is provided for use with deep wounds having a
wound surface including side walls, for example. Dome-shaped member 419 is
able
to conform to side portions of a deeper wound bed, for example, to provide the
side
portions of the wound surface, as well as the bottom portion of the wound
surface
with suction and irrigation treatment. A port (not shown, but similar to port
51) is
centrally located within member 419 and passageways 456 in communication with
connecter 23 extend radially therefrom, as shown in Fig. 31. Concentric
passageways
458 positioned around the port are also provided. Member 419 includes a cover
422
and a wound contacting layer 420 including a convex wound contacting surface
84
and through holes 36 in communication with passageways 456, 458. Wound
contacting surface 84 is premolded to form the convex shape.
As mentioned above and shown in Figs. 17-22, member 19 includes a
wound contacting layer 80 and a cover 52 coupled to the wound contacting layer
80 to
form passageways 56. Passageways 56 are formed by the cooperation of layer 80
and,
cover 52. Specifically, passageways 56 are defined by the channels 28, 30 of
layer 80
and the bottom surface 55 of cover 52 which covers and closes each channel 28,
30 to
form passageways 56. It is within the scope of this disclosure, however, to
form
passageways 56 between a wound contacting layer 520 and a cover 522, as shown
in
Fig. 33, for example. A member 519, as shown in Figs. 33 and 34, includes
wound
contacting layer 520 and cover 522 coupled to wound contacting layer 520.
Connecter 23 is coupled to top surface 53 of cover 522 and is in communication
with
CA 02813265 2013-04-08
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port 51 of cover 522. Cover 522 further includes a plurality of channels 530
radiating
from port 51 and a plurality of concentric channels 531 formed around port 51.
Further, cover 522 includes bosses 90 coupled to bottom surface 55.
Wound contacting layer 520 includes through holes 36. Opposite
surface 85 of layer 520 is smooth such that passageways 562 are formed when
layer
520 and cover 522 are coupled together. Effectively, member 19 and member 519
each include a port 51 in communication with vacuum source 12 and/or
irrigation
source 14, passageways 56 in communication with port Si and connecter 23, and
holes 36 in communication with passageways 56 and formed through wound
contacting layers 80, 520. Member 19 and member 519 each further include
bosses
90 to prevent port 51 from becoming sealed off by central area 87 when suction
is
applied to bandage 11. Bosses 90 provide an uncollapsable space in central
area 87
between port 51 and passageways 56.
Members 19, 119, 219, 319, 419, and 519 discussed above are
illustratively each provided for use with vacuum source 12 and irrigation
source 14.
As illustrated, these embodiments are provided with one port 51 for
communication
with either the vacuum source 12 or the irrigation source 14 or both. However,
a
member 616 is shown in Figs. 35 and 36 and includes port 51, cover 52, layer
80
having a smooth or textured wound contacting surface 84, and an irrigation
layer 650
coupled to surface 84 of layer 80. Irrigation layer 650 includes an irrigation
port 652
for communication with irrigation source 14, as shown diagrammatically in Fig.
36.
Irrigation layer 650 includes an upper surface 654 and a lower surface 656. As
shown
in Fig. 36, lower surface 656 is positioned to lie adjacent to the wound bed
surface 18
and upper surface 654 is coupled to surface 84 of layer 80. As illustrated in
this
embodiment, layer 80 does not contact the wound bed surface 18; layer 80 acts
as an
intermediate layer positioned between cover 52 and irrigation layer 650.
Irrigation
layer 650 lies on the wound bed surface 18.
Further, irrigation layer 650 includes a plurality of channels 656
formed in upper surface 654 in communication with irrigation port 652 via a
central
channel 658 which is also formed in upper surface 654. Irrigation through
holes 660
are formed in irrigation layer 650 and are positioned to lie within channels
656 and
central channel 658. Fluid from irrigation source 14 flows through irrigation
port 652
to central channel 658 and lateral channels 656, and finally flows through
irrigation
CA 02813265 2013-04-08
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holes 660 to the wound bed surface 18, as shown in Fig. 36. Irrigation layer
650
further includes vacuum holes 662 positioned around channels 656, 658. Vacuum
holes 662 communicate with the wound bed surface 18 and with through holes 36
of
intermediate layer 80. Vacuum holes 662 do not directly communicate with
channels
656, 658 of irrigation layer 650. Irrigation layer 650 is illustratively made
from the
same material as cover 52 and intermediate layer 80 such as silicone, for
example.
Cover 52 and layer 80 are the same cover and layer 22, 80 as those
shown in Fig. 17 and discussed above. Connecter 23 coupled to cover 52 is
provided
for communication with vacuum source 12. When cover 52, intermediate layer 80,
and irrigation layer 650 are coupled together, as shown in Fig. 34,
passageways 56 are
formed between cover 52 and intermediate layer 80, as discussed above, and
irrigation passageways 664 are formed between surface 84 of layer 80 and upper
surface 654 of intermediate layer 650. Passageways 56 are in communication
with
vacuum source 12 while passageways 664 are in communication with irrigation
source 14. As shown in Fig. 36, fluid flows into passageways 664 and out
irrigation
holes 660 to reach wound bed surface 18. This irrigation fluid and exudate
from the
wound surface 18 is then sucked up through vacuum holes 662 of irrigation
layer 650
and through holes 36 of layer 80 to passageways 56 and finally out port 51 of
cover
52. Member 619 allows simultaneous delivery of irrigation fluid to the wound
surface 18 and application of suction to the wound bed surface 18 through
separate
and distinct passageways. Although the particular structure of member 619 is
shown
in Figs. 35 and 36 and discussed above, it is within the scope of this
disclosure to
include any member having separate and distinct passageways for delivering
fluid to
and drawing a vacuum on the wound surface 18. It will be appreciated that, in
some
circumstances, the irrigation and suction may take place simultaneously.
Yet another illustrative member 719 is shown in Figs. 37 and 38
including a wound contacting layer 80 and a cover 52 coupled to the layer 80.
Member 719 further includes a filament or wire form 78 molded into the body of
cover 52, as shown in Fig. 38, for example. Wire form 78 is provided to allow
for a
caregiver to mold member 719 into a desired shape, such as to the shape of the
wound
16, for example. Member 719 will retain that shape due to the wire form 78
molded
into the cover 52. Illustrative wire form 78 is a metal grid, as shown in Fig.
37;
however, it is within the scope of this disclosure to include any type or
configuration
CA 02813265 2013-04-08
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of a filament, fine screen, or wire form which retains its shape once formed
to fit a
particular shape as desired by the caregiver. Further, it is within the scope
of this
disclosure for the wire form 78 to be molded into either wound contacting
layer 80 (or
member 20) or cover 52 or both. Further it is within the scope of this
disclosure to
include wire form 78 molded into the cover and/or wound irrigation layer of
any of
the previously disclosed embodiments.
Yet another illustrative member 819 is shown in Figs. 39 and 40. A
wound contacting layer 820 includes an adhesive 850 about the outer perimeter
of
wound contacting surface 84 of layer 820. As shown in Fig. 40, cover 52 is
coupled
to opposite surface 85 of layer 820 and connecter 23 is coupled to top surface
53 of
cover 52. Adhesive 850 is provided to seal to the patient's healthy skin 60
surrounding wound 16. Adhesive 850, therefore, permits member 819 to be self-
sealing such that a vacuum or negative pressure can be created above wound
surface
18 without the use of sealing film 62. In order for adhesive 850 to be able to
effectively seal to healthy skin 60, passageways 56 of member 819 are not
formed to
extend to the peripheral edges of member 819 unlike passageways 56 of member
19
which do extend to the peripheral edges of member 19. Although adhesive 850 is
shown to be coupled to layer 820, it is within the scope of this disclosure to
provide
any member having an adhesive for attachment to the patient's healthy skin
surrounding the wound so that the member is self-sealing and able to maintain
a
negative pressure above the wound without the use of a sealing film. For
example,
the wound contacting layer may be sized smaller than the cover and the bottom
surface of the cover may include an outer adhesive perimeter for coupling with
the
patient's surrounding healthy skin.
Yet another illustrative member 919 is shown in Figs. 42- 44. Member
919 is similar to the other members disclosed above and includes a wound
contacting
layer 920, cover 52 coupled to layer 920, and a connector 923 coupled to cover
52.
As shown in Figs. 42 and 44, connector 923 differs from connector 23 because
connector 923 includes an outer wall 926 defining a single passageway 928 to
port 51
of cover 52. Outer wall 926 and passageway 928 are positioned at an angle to
top
surface 53 of cover 52. In the illustrative embodiment, the included angle
between an
axis defined by passageway 928 and the top surface of cover 52, when cover 52
is in a
flat configuration, is about 30 degrees.
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It is understood that member 919 operates in the same or similar
manner as the other members, such as members 19 and 20, described above. As
such,
the same reference numerals have been used to designate similar components to
those
components previously discussed and additional discussion thereof is not
warranted.
One difference between member 919 and members 19 and 20 is that
member 919 includes a single stand-off 940, shown in Fig. 43, which generally
forms
a spider-web-like pattern. Stand-off 940 is coupled to wound contacting or
wound
facing surface 84 and includes interconnecting portions or ridges including
radial
arms 942, circle portion 944, and arc portions 946 concentric with circle
portion 944.
Specifically, stand-off 940 includes eight radial arms 942 extending outwardly
from
circle portion 944 and through arc portions 946. It is within the scope of
this
disclosure, however, to include a stand-off having more circles portions
and/or arc
portions interconnected by more or less radial arms. Further, it is within the
scope of
this disclosure to include a stand-off forming other suitable interconnected
patterns
than that shown in Fig. 43. Although stand-off 940 includes radial arms 940,
circle
portion 944, and arc portions 946, the entire stand-off 940 is molded or
formed as a
single interconnected unit.
Stand-off 940 operates to position wound facing surface 84 of wound
contacting layer 920 away from wound surface 18 of wound 16 (shown in Figs. 3,
7,
and 17). By positioning wound facing surface 84 away from wound surface 18,
holes
36 (not visible in Fig. 42, but shown in Figs. 43 and 44) of layer 920 are
less likely to
form an unwanted seal against wound surface 18. Stand-off 940 allows vacuum
source 12 to establish a generally uniformly distributed negative pressure to
draw
exudate from the wound 16 through holes 36 and into channels 28, 30, of layer
920.
Stand-off 940 is not provided to direct fluid flow toward any single hole 36,
but
instead, to prevent the holes 36 from becoming closed off and forming an
unwanted
seal against wound surface 18. As shown in Fig. 43, for example, stand-off 940
forms
either fully or partially closed-off portions or encompassed regions of wound
facing
surface 84 defined by circle portion 944, radial arm portions 942, and arc
portions
946. Each of the majority of the closed-off portions has multiple holes 36
associated
therewith. Thus, each closed-off portion has portions of stand-off 940 fully
or
partially surrounding or encompassing associated holes 36.
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Illustratively, the radial arms 930 and arc portions 934 of stand-off 940
extend to the outer peripheral edges of layer 920. It is within the scope of
this
disclosure, however, to include a stand-off having radial arms and/or arc
portions
which do not extend all the way to the outer peripheral edge of layer 920.
Further
illustratively, each radial arm 930, each arc portion 934, and circle portion
932 has a
semi-circle shaped cross-section having a radius of about 0.0625 inch (1.588
mm).
As mentioned above, another difference between member 919 and
members 19 and 20, for example, is that member 919 includes angled connector
923,
as shown in Figs. 42 and 44. Passageway 928 of connector 923 provides a
generally
straight flow path for the exudate removed from wound 12 through member 919 by
vacuum source 12 and for the liquid delivered to wound 12 through member 19 by
irrigation source 14.
As shown in Fig. 44, a barbed tube coupler 950 is provided to couple
connector 23 with a multi-lumen vacuum/irrigation tube 913. Illustratively,
tube 913
includes an inner lumen 952 defined by an outer wall 954 of the tube 913. Tube
913
further includes outer lumens 956 formed in outer wall 954. As shown in Fig.
44,
inner lumen 952 is in communication with passageway 928 of connector 923 via
the
tube coupler 950 while outer lumens 956 are open to the area around member 919
through an end edge 915 of tube 913.
Barbed tube coupler 950 is received within inner lumen 952 and
passageway 928. Coupler 950 includes a tube portion 960, a connector portion
962,
an intermediate portion 964 coupled to and positioned between tube portion 960
and
connector portion 962, and a passageway 966 through each of the tube portion
960,
connector portion 962, and intermediate portion 964. Tube portion 960 is
positioned
within inner lumen 952 of tube 913 and includes a barb 970 to prevent tube
portion
960 from being easily removable from tube 913. Connector portion 962 is press
fit
into connector 923 and includes an angled end 972 to generally engage and lie
adjacent to cover 52. Intermediate portion 964 is positioned between and abuts
each
of the tube 913 and connector 923, as shown in Fig. 44. In some embodiments,
adhesive or sealant is applied to either or both of portions 960, 962 to
further enhance
the connection between tube portion 960 of coupler 950 and tube 913 and
between
connector portion 962 of coupler 950 and connector 923.
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Although this invention has been described in detail with reference to
certain embodiments, variations and modifications exist within the scope of
the invention as described and defined in the following claims.
=
