U.S. patent application number 14/447579 was filed with the patent office on 2014-11-20 for integrated negative pressure bandages.
The applicant listed for this patent is Oakwell Distribution, Inc.. Invention is credited to John-Yuhan Bai, John A. Bennett.
Application Number | 20140343520 14/447579 |
Document ID | / |
Family ID | 44718921 |
Filed Date | 2014-11-20 |
United States Patent
Application |
20140343520 |
Kind Code |
A1 |
Bennett; John A. ; et
al. |
November 20, 2014 |
Integrated Negative Pressure Bandages
Abstract
An integrated negative pressure bandage is constructed with a
non-woven polyurethane matrix pad secured on the outside surface to
a sheet of polyurethane film formed with an outer adhesive boundary
to establish a seal against the skin of the patient around the
wound site. The integrated negative pressure bandage is applied to
a patient having said wound by removing said release member and
attaching said adhesive layer exposed by the removal of said
release member to said patient such that said adhesive layer is
sealed to the patient around said wound with said non-woven polymer
matrix pad being positioned over said wound, and attaching said
connector port to said source of negative pressure. The non-woven
pad does not stored fluids and exudate, but the source of negative
pressure continuously removes the fluids and exudate to a remote
location.
Inventors: |
Bennett; John A.;
(Villanova, PA) ; Bai; John-Yuhan; (San Gabriel,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Oakwell Distribution, Inc. |
King of Prussia |
PA |
US |
|
|
Family ID: |
44718921 |
Appl. No.: |
14/447579 |
Filed: |
July 30, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13207391 |
Aug 10, 2011 |
8795247 |
|
|
14447579 |
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Current U.S.
Class: |
604/319 |
Current CPC
Class: |
A61F 13/00068 20130101;
A61F 2013/00536 20130101; A61F 2013/00174 20130101; A61F 2013/0054
20130101; A61M 1/0088 20130101; A61F 2013/00412 20130101 |
Class at
Publication: |
604/319 |
International
Class: |
A61F 13/00 20060101
A61F013/00; A61M 1/00 20060101 A61M001/00 |
Claims
1. An integrated negative pressure bandage connectable to a source
of negative pressure to remove fluids and exudate from a wound,
comprising: a non-woven polymer matrix pad having an upper surface
and a lower surface, said lower surface being positionable adjacent
to and in engagement with said wound; a polymer film cover
integrally affixed to said upper surface of said pad, said film
cover having a peripheral boundary surrounding said pad, said film
cover having a peripheral boundary surrounding said pad and an
opening therethrough, said peripheral boundary including an
adhesive layer mounted thereon and projecting outwardly from said
non-woven polymer matrix pad such that said adhesive layer is
operable to form a seal around said wound with said non-woven
polymer matrix pad being positioned over said wound; a connection
port integrally secured to said film cover in flow communication
with said opening, said connection port being connectable to said
source of negative pressure to extract fluids and exudate from said
wound through said non-woven polymer matrix pad; a mesh layer
covering said lower surface of said pad and being integrally
secured to said film cover; and a release member removably attached
to said adhesive layer, said release member being an integral part
of said bandage before being removed from said adhesive layer to
expose said adhesive layer for sealing around said wound.
2. The integrated negative pressure bandage of claim 1 wherein said
mesh layer is impregnated with silver nitrate.
3. The integrated negative pressure bandage of claim 1 wherein said
non-woven polymer matrix pad and said polymer film cover have an
oval shape.
4. The integrated negative pressure bandage of claim 1 wherein said
fluids and exudate from said wound are not stored within said
non-woven polymer matrix pad and are continuously removed from said
non-woven polymer matrix pad through said connection port.
5. The integrated negative pressure bandage of claim 1 wherein said
connection port is integrally secured to said polymer film cover by
a seal pad that surrounds said connection port and is secured by
adhesive to said polymer film cover.
6. The integrated negative pressure bandage of claim 1 wherein said
bandage is applied to a patient having said wound by removing said
release member and attaching said adhesive layer exposed by the
removal of said release member to said patient such that said
adhesive layer is sealed to the patient around said wound with said
non-woven polymer matrix pad being positioned over said wound, and
attaching said connector port to said source of negative
pressure.
7. An integrated negative pressure bandage connectable to a source
of negative pressure to remove fluids and exudate from a wound,
comprising: a non-woven polymer matrix pad having an upper surface
and a lower surface, said lower surface being positionable adjacent
to and in engagement with said wound; a polymer film cover
integrally affixed to said upper surface of said pad, said film
cover having a peripheral boundary surrounding said pad, said film
cover having a peripheral boundary surrounding said pad and an
opening therethrough, said peripheral boundary including an
adhesive layer mounted thereon and projecting outwardly from said
non-woven polymer matrix pad such that said adhesive layer is
operable to form a seal around said wound with said non-woven
polymer matrix pad being positioned over said wound; a connection
port integrally secured to said film cover in flow communication
with said opening, said connection port being connectable to said
source of negative pressure to extract fluids and exudate from said
wound through said non-woven polymer matrix pad, said connection
port being integrally secured to said polymer film cover by a seal
pad that surrounds said connection port and is secured by adhesive
to said polymer film cover; and a release member removably attached
to said adhesive layer, said release member being an integral part
of said bandage before being removed from said adhesive layer to
expose said adhesive layer for sealing around said wound.
8. The integrated negative pressure bandage of claim 7 further
comprising a mesh layer covering said lower surface of said pad and
being integrally secured to said film cover.
9. The integrated negative pressure bandage of claim 8 wherein said
mesh layer is impregnated with silver nitrate.
10. The integrated negative pressure bandage of claim 7 wherein
said non-woven polymer matrix pad and said polymer film cover have
an oval shape.
11. The integrated negative pressure bandage of claim 7 wherein
said fluids and exudate from said wound are not stored within said
non-woven polymer matrix pad.
12. The integrated negative pressure bandage of claim 11 wherein
said fluids and exudate are continuously removed from said
non-woven polymer matrix pad through said connection port.
13. The integrated negative pressure bandage of claim 7 wherein
said bandage is applied to a patient having said wound by removing
said release member and attaching said adhesive layer exposed by
the removal of said release member to said patient such that said
adhesive layer is sealed to the patient around said wound with said
non-woven polymer matrix pad being positioned over said wound, and
attaching said connector port to said source of negative
pressure.
14. An integrated negative pressure bandage connectable to a source
of negative pressure to remove fluids and exudate from a wound,
comprising: an oval-shaped, non-woven polymer matrix pad having an
upper surface and a lower surface, said lower surface being
positionable adjacent to and in engagement with said wound; an
oval-shaped polymer film cover integrally affixed to said upper
surface of said pad, said film cover having a peripheral boundary
surrounding said pad, said film cover having a peripheral boundary
surrounding said pad and an opening therethrough, said peripheral
boundary including an adhesive layer mounted thereon and projecting
outwardly from said non-woven polymer matrix pad such that said
adhesive layer is operable to form a seal around said wound with
said non-woven polymer matrix pad being positioned over said wound;
a connection port integrally secured to said film cover in flow
communication with said opening, said connection port being
connectable to said source of negative pressure to extract fluids
and exudate from said wound through said non-woven polymer matrix
pad, said connection port being integrally secured to said polymer
film cover by a seal pad that surrounds said connection port and is
secured by adhesive to said polymer film cover; a mesh layer
covering said lower surface of said pad and being integrally
secured to said film cover; and a release member removably attached
to said adhesive layer, said release member being an integral part
of said bandage before being removed from said adhesive layer to
expose said adhesive layer for sealing around said wound.
15. The integrated negative pressure bandage of claim 14 wherein
said mesh layer is impregnated with silver nitrate.
16. The integrated negative pressure bandage of claim 14 wherein
said bandage is applied to a patient having said wound by removing
said release member and attaching said adhesive layer exposed by
the removal of said release member to said patient such that said
adhesive layer is sealed to the patient around said wound with said
non-woven polymer matrix pad being positioned over said wound, and
attaching said connector port to said source of negative pressure.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 13/207,391, filed Aug. 10, 2011, and granted as U.S. Pat.
No. 8,795,247 on Aug. 5, 2014, and claims domestic priority on U.S.
Provisional Patent Application Ser. No. 61/373,233, filed on Aug.
12, 2010, the content of which is incorporated herein by reference
in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to negative pressure
bandages operable to remove exudates and fluids from a wound and,
more particularly, to a bandage structure that is specifically
contoured to fit body parts that present difficulties in affixing
and applying negative pressure bandages.
BACKGROUND OF THE INVENTION
[0003] Negative pressure therapy has been utilized for the
treatment of a variety of wounds by medical practitioners.
Conventional negative pressure bandages are generally large in size
and often require the use of complicated equipment such as suction
pumps, vacuum pumps and complex electronic controllers to apply a
negative pressure within the bandage to draw exudates and fluids
away from the wound to a remote collection container. Typically,
negative pressure therapy involves other associated equipment, such
as the exudates/fluid collection canisters, liquid transporting
conduits, and pressure regulators/transducers/sensors. As a result,
negative pressure bandages and related equipment tends to be bulky
and relatively costly. Such complexity typically requires
professional placement of the bandage and connection to the pump
and collection canister, followed by consistent, regular patient
supervision and monitoring. Generally, negative pressure bandages
are applied for approximately two days, at which time the bandage
must be removed and replaced by professional technicians.
[0004] The rising costs of healthcare and of medical devices, such
as negative pressure bandages, provide incentive to develop less
expensive equipment, and procedures that are more easily utilized
to reduce the costs associated with the use of negative pressure
therapy while improving on the effectiveness of the therapy.
Simplification of the procedures and the equipment can allow
in-home use of such therapies with a minimum of professional
supervision and monitoring of the patients. Furthermore, patients
continue to demand devices that are more easily portable to allow
travel and mobility while utilizing the therapy.
[0005] Conventional applications of negative pressure therapy to
wound sites typically incurs the cutting of a porous foam pad to
fit into the wound, followed by an application of an adhesive
surgical drape over the pad and wound site to seal against the skin
of the patient around the wound site. The fluids and exudates from
the wound can be removed from the bandage to a remote location
through an application of a vacuum to a connector fitted into the
adhesive surgical drape, such as is shown in U.S. Pat. No.
5,636,643, granted on Jun. 10, 1997, in U.S. Pat. No. 5,645,081,
granted on Jul. 8, 1997, and in U.S. Pat. No. 7,216,651, granted on
May 15, 2007, all of which were issued to Louis Argenta.
Alternatively, the foam pad can be utilized as a storage reservoir
by incorporating a hydrophobic filter at the connector to prevent
the fluids from leaving the bandage, as is reflected below in
greater detail. Negative pressure therapy is provided commercially
by at least KCI, Smith & Nephew, Kalypto, Medela, Mepilex and
Convatec. An earlier negative pressure wound therapy embodiment is
disclosed in U.S. Pat. No. 4,969,880, issued to David S.
Zamierowski on Nov. 13, 1990.
[0006] The application of conventional negative pressure bandages
to certain parts of the body presents substantial difficulties in
maintaining a seal against the skin around the wound. Without the
negative pressure bandage being sealed against the skin of the
patient, the negative pressure system will not operate. Certain
body parts, such as heels, ankles and toes present a multi-faceted
skin surface against which the negative pressure bandage must seal.
Conventional practices with the negative pressure bandages, such as
are described below, require the planar bandages to be cut, shaped
and compromised with respect to the sealing portion of the bandage
to fit against the contoured body part.
[0007] In U.S. Pat. No. 7,615,036, granted to Ashok Joshi, et al on
Nov. 10, 2009, a negative pressure bandage is disclosed in which
the bandage has a housing that is sealed to the body surface of the
patient and defines a liquid retention chamber coupled to a vacuum
source to apply a negative pressure on the liquid retention chamber
so that the exudates and fluids are drawn into an absorptive
material within the liquid retention chamber. This liquid retention
chamber is located adjacent to the wound from which the exudates
and fluids are removed.
[0008] Improvements to negative pressure wound therapy devices can
be found in U.S. Patent Publication No. 2009/0299251 of John Buan
published on Dec. 3, 2009, to enhance the sealing of the bandage to
the body surface of the patient. In this negative pressure wound
therapy device, a vacuum is applied to a collection chamber in
which an absorptive pad is disposed to collect the exudates and
fluids drawn away from the wound by the vacuum (negative pressure).
To enhance the connection of the tubing extending between the
vacuum pump and the negative pressure therapy device, an extended
length connector is disclosed, which will accommodate connection
when ace wrap or other coverings are applied to the exterior of the
bandage.
[0009] In U.S. Pat. No. 7,361,184, granted on Apr. 22, 2008, to
Ashok Joshi, an attempt to provide a self-contained negative
pressure wound therapy device is provided so that the device does
not require connection to a remote vacuum source. In this negative
pressure wound dressing, an absorptive pad is also disposed in the
fluid collection chamber, which is located adjacent to the wound,
the negative pressure drawing the exudates and fluids away from the
wound into the absorptive pad. Several early embodiments of
negative pressure bandages can be found in U.S. Pat. No. 5,636,643,
granted to Louis Argenta, et al on Jun. 10, 1997, all of which,
however, utilize a single chamber configuration in which a vacuum
is applied to the fluid collection chamber and the exudates and
fluid is drawn away through tubing to a remote pump and fluid
retention chamber.
[0010] It would be desirable to provide a contoured negative
pressure bandage that will be adapted to be affixed to a specific
contoured body part to remove exudates and fluid from a wound
located on that contoured body part.
SUMMARY OF THE INVENTION
[0011] It is an object of this invention to overcome the
disadvantages of the prior art by providing an integrated negative
pressure wound therapy bandage.
[0012] It is another object of this invention to provide negative
pressure wound therapy bandages that are contoured to fit specific
areas of a patient's body that are conventionally difficult to
provide a seal for use in negative pressure wound therapy.
[0013] It is a feature of this invention that a negative pressure
bandage is integrated into a single applicable bandage that can
provide negative pressure wound therapy.
[0014] It is an advantage of this invention that the components
parts of the negative pressure bandage do not require individual
installation on a patient to provide negative pressure wound
therapy.
[0015] It is another advantage of this invention that the
integrated bandage is not inserted into the surface of the wound,
but is positioned over top of the wound, to provide negative
pressure wound therapy.
[0016] It is another feature of this invention that the integrated
bandage structure provides a non-woven polyurethane matrix mesh
impregnated with silver nitrate to overlie the wound being
treated.
[0017] It is still another advantage of this invention that the
silver nitrate mesh inhibits infection and promotes healing of the
wound.
[0018] It is yet another feature of this invention that the
integrated bandage structure also includes a drain tube disposed
within the non-woven polyurethane matrix for connection to a source
of negative pressure to withdraw the exudates and fluids from the
wound to a remote canister for collection thereof.
[0019] It is yet another advantage of this invention that the
non-woven matrix does not absorb the fluids and exudates, but
allows the collection thereof into the drain tube for removal from
the bandage and from the wound site.
[0020] It is still another object of this invention to provide a
therapy for wounds to keep the wound clear of excessive moisture
and exudates, and to promote healing of the wound.
[0021] It is yet another object of this invention to provide an
integrated negative pressure bandage that is configured to fit onto
portions of the human body that is difficult to attach a negative
pressure bandage.
[0022] It is an advantage of this invention that the contoured
negative pressure bandages are configured to provide a seal around
a wound found on certain difficult to fit portions of the human
body.
[0023] It is still another object of this invention to provide
negative pressure bandages that are contoured to fit on the foot,
at both the toe and heel portions of the foot, on limbs, and on the
sacral region of the human body and provide a seal against the skin
around the wound so that negative pressure therapy can be provided
to the wound site.
[0024] It is yet another advantage of this invention that the time
to apply a negative pressure bandage to a wound site is reduced by
the utilization of an integrated bandage that allows the wound
fluids and exudates to be withdrawn from the bandage to a remote
canister.
[0025] It is a further feature of this invention that the contoured
negative pressure bandage for application to the heel of a
patient's foot is formed with junctions, such as cutouts, to
facilitate the sealing of the bandage around the heel.
[0026] It is still a further feature of this invention that the
drain tube and associated connector can be oriented diagonally to
the primary axes of the bandage to position the connector for
attaching the vacuum source to the drain tube in an easily
accessible and unobtrusive location.
[0027] It is yet another object of this invention to provide an
integrated negative pressure bandage that is durable in
construction, inexpensive of manufacture, facile in assemblage, and
simple and effective in use.
[0028] It is a further object of this invention to provide a
negative pressure bandage that is contoured to fit portions of the
human body that are difficult to apply negative pressure wound
therapy to establish an integrated negative pressure bandage that
is simple and effective in use.
[0029] These and other objects, features and advantages are
accomplished according to the instant invention by providing an
integrated negative pressure bandage having a non-woven
polyurethane matrix pad secured on the outside surface to a sheet
of polyurethane film formed with an outer adhesive boundary to
establish a seal against the skin of the patient around the wound
site. The inner surface of the non-woven matrix pad is covered with
a silver nitrate mesh to promote healing of the wound site when the
bandage is placed on top of the wound. A drain tube is contained
within the non-woven matrix pad for connection with a source of
negative pressure to draw the fluids and exudates from the wound
for removal to a canister that is located remotely from the
bandage. Contoured versions of the integrated bandage are provided
for use on portions of the human body that present difficult
locations for applications of negative pressure therapy, including
the toes, heel, limbs, and sacral region.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The foregoing and other objects, features, and advantages of
the invention will appear more fully hereinafter from a
consideration of the detailed description that follows, in
conjunction with the accompanying sheets of drawings. It is to be
expressly understood, however, that the drawings are for
illustrative purposes and are not to be construed as defining the
limits of the invention.
[0031] FIG. 1 is a perspective view of an integrated negative
pressure bandage incorporating the principles of the instant
invention, the bandage of FIG. 1 being shaped for utilization for
injuries or wounds to generally planar portions of the body;
[0032] FIG. 2 is a side perspective view of the integrated negative
pressure bandage shown in FIG. 1;
[0033] FIG. 3 is a cross-sectional view of the integrated negative
pressure bandage corresponding to lines 3-3 of FIG. 2;
[0034] FIG. 4 is a top plan view of an integrated bandage similar
to that of FIG. 1, but having a circular shape;
[0035] FIG. 5 is a cross-sectional view of the integrated bandage
corresponding to lines 5-5 of FIG. 4;
[0036] FIG. 6 is an exploded view of a different embodiment of the
integrated negative pressure bandage similar to that shown in FIGS.
1 and 4;
[0037] FIG. 7 is an upper perspective view of a first embodiment of
a drain tube and connector utilized in the planar bandage shown in
FIG. 1;
[0038] FIG. 8 is a side elevational view of the drain tube and
connector shown in FIG. 7; and
[0039] FIG. 9 is an upper perspective view of an alternate
embodiment of a drain tube as shown in FIG. 7;
[0040] FIG. 10 is a side elevational view of the drain tube shown
in FIG. 9;
[0041] FIG. 11 is a top plan view of a first embodiment of a
contoured negative pressure bandage incorporating the principles of
the instant invention for a patient's foot, shown in an opened
configuration in which the bandage would be shipped to the patient,
the release members not being shown for purposes of clarity;
[0042] FIG. 12 is a side elevational view of the contoured negative
pressure bandage for a foot as shown in FIG. 11, the release
members not being shown for purposes of clarity;
[0043] FIG. 13 is a perspective view of the contoured negative
pressure bandage as shown in FIG. 11 folded over the toes on the
foot of a representative patient;
[0044] FIG. 14 is a top plan view of a second embodiment of the
contoured negative pressure bandage for a patient's foot, the
release members not being shown for purposes of clarity;
[0045] FIG. 15 is a top plan view of a third embodiment of the
contoured negative pressure bandage for a foot, the bandage being
shown in an unfolded configuration corresponding to the
configuration in which the bandage would be shipped to the patient
for subsequent use, the release members not being shown for
purposes of clarity;
[0046] FIG. 16 is a perspective view of a wedge member for use in
conjunction with the contoured negative pressure bandage shown in
FIGS. 12-16;
[0047] FIG. 17 is a top plan view of a contoured negative pressure
bandage for use with a patient's heel;
[0048] FIG. 18 is a bottom plan view of the contoured negative
pressure bandage for heels as shown in FIG. 17, the release members
not being shown for purposes of clarity;
[0049] FIG. 19 is an exploded view of the contoured negative
pressure bandage for heels as shown in FIG. 17;
[0050] FIG. 20 is a side elevational view of the contoured negative
pressure bandage for heels;
[0051] FIG. 21 is a top plan view of an alternative embodiment of
the contoured negative pressure bandage for heels, similar to that
shown in FIG. 17;
[0052] FIG. 22 is a top plan view of the contoured negative
pressure bandage for use on the sacral region of a patient; and
[0053] FIG. 23 is a perspective view of the contoured negative
pressure bandage shown in FIG. 22.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0054] Referring to the FIGS. 1-6, integrated negative pressure
bandages incorporating the principles of the instant invention can
best be seen. One of ordinary skill in the art will recognize that
the scale of the components of the negative pressure bandages is
exaggerated to shown the details of the components. For example,
the wound contact member depicted in each of the drawings is
enlarged to shown the configuration thereof. The thicknesses and
relative sizes of other components may also be distorted to show
the invention. Specific contoured configurations of the integrated
negative pressure bandages are depicted in FIGS. 12-23.
[0055] The different embodiments of the contoured negative pressure
bandages shown in the drawings have some common features relating
to the formation of the integrated negative pressure bandage. Each
of the bandages have an outer shaped cover formed from a liquid
impermeable material, such as polyurethane film, that can be formed
into the specific shape required for the bandage configuration, yet
provide sufficient flexibility to allow attachment of the bandage
to the skin surrounding the injury being treated. The outer cover
is provided with an area of adhesive around a perimeter portion of
the bandage where the cover would be engaged with the skin around
the wound being treated to create a seal between the perimeter of
the bandage and the skin. A protective release film would be
applied to the adhesive portion until the bandage is to be applied
to a patient, substantially covering the entire inner surface of
the bandage.
[0056] Furthermore, each of the bandages will have a wound contact
member secured to the outer film cover to be positioned between the
cover and the body part being treated. While this wound contact
member can be formed from gauze padding covered by a mesh layer,
preferably a polyethylene mesh impregnated with silver nitrate, the
wound contact member is preferably formed with a permeable polymer
matrix layer, more specifically a non-woven polyurethane matrix pad
is preferred, that will allow the passage of liquids through the
pad to keep the surface of the wound contact member against the
wound site as dry as possible. Within this wound contact padding is
a drain tube connected to an external connector to apply a negative
pressure to the bandage that will draw the fluids and exudates from
the wound being treated. The surface of the wound contact member,
which is in direct contact with the wound being treated, is
provided with a mesh layer, preferably a polyethylene mesh
impregnated with silver nitrate, to protect the wound and promote
healing. In operation, the negative pressure bandage keeps the
wound dry and does not allow the fluid to accumulate within the
bandage, thus keeping the bandage from bulking up with accumulated
fluids that can disrupt the seal around the perimeter of the
bandage.
[0057] Referring now to FIGS. 1-6, an integrated negative pressure
bandage 10 incorporating the principles of the instant invention
can best be seen. The bandage 10 is formed with a non-woven polymer
matrix pad 15 covered on an inside surface by a polyethylene mesh
layer 12 that serves as a wicking function to draw fluids into the
pad 15 and keeps the pad 15 from engaging the surface of the wound
when the bandage 10 is applied. Preferably, the mesh layer
incorporates a coating of, or is impregnated with, a compound of
silver nitrate to promote healing and inhibit infection. The outer
surface of the non-woven polymer pad 15 is attached to a
polyurethane film 13 formed with an adhesive covered perimeter
portion 14. A drain tube 20 is positioned within the pad 15 and
exits the bandage 10 through an opening within the polyurethane
film 13 to terminate in a connector 22 adapted for connection to a
conduit leading to a vacuum source (not shown) and an associated
canister reservoir (not shown). A seal pad 23 can be provided at
the opening through the polyurethane film 13 for engagement with
the connector 22 to enhance the seal of the bandage 10 when applied
to a patient.
[0058] Preferably, the polyurethane film 13 can be formed with an
inner transparent film member 13a and an outer opaque, or skin
colored, film member 13b. The adhesive-covered surface of the
polyurethane film member 13a is preferably covered by a release
member 16 that is removed from the bandage 10 when the bandage is
to be applied to the patient to expose the adhesive boundary 14 for
attachment to the patient's skin around the wound site. More
preferably, the release member 16 covers the entire inside surface
of the bandage 10 before being removed and can be formed as
overlapping members 16a and 16b. The outer film member 13b is
preferably constructed from non-woven polyurethane to provide a
covering that has a look somewhat like human skin.
[0059] The general configuration of the drain tube 20 and connector
22 utilized in each of the bandages described above and below, is
shown generically in FIGS. 7-10. One skilled in the art will
recognize that the drain tube 20 can be shaped specifically to
conform to any particular shape or configuration of the bandage 10;
however, FIGS. 7-10 depict the drain tube 20 as having a linear
configuration. One skilled in the art will also understand that the
length and width of the drain tube 20 is also dependent on the size
and shape of the specific bandage 10. The connector 22 is of a
conventional size and shape for connection to tubing that would
interconnect the connector 22 with a vacuum pump (not shown).
[0060] The drain tube 20 in the first embodiment depicted in FIGS.
7 and 8 is formed from a pair of opposing, relatively flat body
fluid collection members 24 that are formed with slotted openings
26 in the top and bottom surfaces thereof to collect fluids and
exudates from the wound through the wound contact member 15. The
opposing fluid collection members 24 are connected to a central
collector member 27 that forms a "T" connection with the external
connector 22 so that the negative pressure applied to the connector
22 extracts the fluids and exudates from the fluid collection
members 24 through the central collector member 27 and out through
the connector 22 to an storage device (not shown).
[0061] A second embodiment of the drain tube 20 is depicted in
FIGS. 9 and 10 as a single tube configuration. The single flat body
fluid collection member 24 is connected at one end thereof to the
connector 22 which can pass through the seal pad 23, and also
through the polyurethane film 13, for connection with the vacuum
source (not shown). As depicted in the embodiment of FIGS. 7 and 8,
the flat fluid collection member 24 is formed with openings 26 in
the top and bottom surfaces. As depicted in FIGS. 8 and 10, the
sides of the fluid collection member 24 can also be formed with
openings 26 and those openings 26 can be in any shape from oval to
circular, or other geometric shapes.
[0062] A first embodiment of a contoured integrated negative
pressure bandage 30 is shown in FIGS. 11-13, configured for use
with the patient's toes. As with the integrated bandage described
above with respect to FIGS. 1-6, this contoured bandage 30 is
formed with an outer polyurethane film cover 13 formed with an
outer adhesive boundary 14 located to the exterior of the mesh 12
which covers the non-woven polymer matrix pad 15. In this
embodiment of the contoured bandage 30, the drain tube 20 is
positioned at one end of the pad 15 such that the fluid collection
member 24 extends substantially to the opposing end of the pad 15.
In FIG. 14, a second embodiment of the foot bandage 32 is shown in
which the drain tube 20 is oriented diagonally across the pad 15
such that the connector 22 is positioned to one side of the bandage
30.
[0063] In the application of this first embodiment of the contoured
bandage 30, as is depicted schematically in FIG. 13, the bandage 30
is wrapped around the ends of the patient's toes in a manner where
the pad 15 is located both above the patient's foot and below the
patient's foot. The drain tube 20 is sufficiently flexible to allow
the associated bend in the bandage 30 such that the fluid
collection member 24 is also located above and below the patient's
foot. The connector 22 is oriented over the top of the foot for
connection to the vacuum pump (not shown). When the second
embodiment of the bandage 32 is applied, the connector 22 is
located at the top of the patient's foot, but to one side of the
foot.
[0064] Yet a third embodiment of the contoured negative pressure
bandage 35 configured for application to a patient's foot is shown
in FIG. 15. The non-woven polymer matrix pad 15 is formed smaller
than the first embodiment shown in FIGS. 11 and 14, and preferably
in a semi-circular shape. The pad 15 is located at one end of the
polyurethane film cover 13, terminating at a center fold line 28 so
that the opposing half of the film cover 13 is devoid of a pad 15.
Furthermore, most of the opposing half of the film cover 13 can be
covered with a layer of adhesive 14. In application, the third
embodiment of the foot bandage 35 is applied so that the pad 15
covers the open wound.
[0065] If the wound is on the bottom of the patient's foot, then
the opposing half of the film cover 13 is wrapped over the ends of
the toes and sealed against the top of the foot. Since the drain
tube 20 is oriented diagonally, the connector 22 will project from
one side of the bandage 35 to be connected to the vacuum pump (not
shown). The ends of the patient's toes should be positioned
proximate to the middle of the pad 15 so that the fold line 28 is
spaced from the ends of the patient's toes. The adhesive areas 14
on the opposing side of the film cover 13 and around the pad 15 and
seal against each other and against the patient's foot to provide a
seal around the pad 15 for the application of negative pressure
therapy.
[0066] In FIG. 16, a wedge member 29 is schematically shown.
Preferably, for ease of manufacture, the wedge member 29 is
rectangular in shape, but could be formed in a triangular or wedge
shape as well. The purpose of the wedge member 29 is to separate
the patient's toes prior to application of the bandage 30, 32 or 25
to the patient's foot. Often the open would on a patient's foot,
whether on top or on the bottom of the foot, will extend between
the patient's toes. Separating the toes adjacent the open wound
with a wedge member 29 will increase the effectiveness of the
negative pressure therapy.
[0067] Referring now to FIGS. 17-21, an integrated bandage 40
contoured for application to a patient's heel is shown. As with the
bandages described above, the heel bandage 40 has a shaped
polyurethane film cover 13 on the outside surface of a non-woven
polymer matrix pad 15 that has a silver nitrate mesh 12 on the
inside surface. The polyurethane film cover 13 has a particular
shape configured to be applied to the patient's heel. The film
cover 13 has an upper rounded portion 42 surrounding an upper
portion 46 of the pad 15 where the connector 22 is located. The
lower portion 43 of the film cover 13 is formed with three flaps 44
projecting outwardly from the lower portion 47 of the pad 15. The
flaps 44 are separated by junctions 45 that provide flexibility in
the application of the adhesive covered flaps 44 to the patient's
skin. The junctions 45 between the flaps 44 can be formed as
cutouts 45, as is shown in FIGS. 17 and 18, or as a web 45a, as is
depicted in FIG. 21. The drain tube 20 in the first embodiment of
the heel bandage 40 is oriented along the major vertical axis of
the bandage 40.
[0068] In application, the heel bandage 40 is positioned so that
the lower portion 47 covers the open wound and the fluids and
exudates can be evacuated from the wound via the drain tube 20. The
rounded upper portion of the film cover 13 is easily applied to the
lower part of the patient's calf irrespective of the orientation of
the heel bandage 40 to the patient. The lower portion 43 of the
film cover 13, however, is typically applied to the patient's
ankle, which is much more difficult to obtain a seal. The junctions
45 between the flaps 44 allow the flaps 44 to be oriented as needed
to obtain a seal against the patient's ankle area. Furthermore, the
junctions 45 provide a place where the medical service provider can
tear the film cover 13 if further modifications become necessary.
In FIG. 21, a second embodiment of the heel bandage 49 is depicted.
The component parts are formed as described above, except for the
orientation of the drain tube 20, which is positioned diagonally
across the pad 15 so that the connector 22 exits the polyurethane
film cover member 13 at one side thereof. Furthermore, the
junctions are depicted as perforated webs 45a between the flaps 44
to allow selective tearing of the webs 45a to accomplish the
folding of the flaps 44 and the sealing of the bandage 10.
[0069] For wounds on the bottom of the heel, the heel bandage 40 is
applied with the lower portion 47 of the pad 15 located under the
foot against the open wound. The upper portion of the film cover 13
can be secured against the back portion of the patient's leg and
the flaps 44 can be wrapped around the sides of the foot and along
the sole. The connector 22 will be oriented vertically in back of
the leg. If the wound is in the rear part of the heel, the lower
part 47 of the pad 15 is positioned over the wound while the flaps
44 are wrapped around the sides of the ankle and underneath the
heel. If the wound is on the ankle along the side of the foot, the
lower part 47 of the pad 15 is placed over the wound with the upper
portion 42 of the film cover 13 being oriented along the side of
the leg. The flaps 44 can then be secured to the inside of the
foot, behind the heel, and underneath the foot. The junctions 45 in
each of the scenarios noted above enable the three respective flaps
44 to be secured against the patient's foot in different planes and
in different orientations.
[0070] An integrated negative pressure bandage 50 contoured to be
applied to the sacral region of the patient is shown in FIGS. 22
and 23. As described above, the sacral bandage 50 is formed with a
non-woven polymer matrix pad 15 having affixed to the outside
surface thereof a polyurethane film cover 13 and to the inner
surface thereof a mesh 12 impregnated with silver nitrate. The
drain tube 20 terminates in a connector 22 above the film cover 13
and includes a fluid collection member 24 embedded into the pad 15.
The bandage 50 is formed with a curved indent 52, 53 at the top and
at the bottom, respectively, to conform to the shape of the sacral
region of the patient. Similarly, the pad 15 is formed with a
curved indent 54 at the top central portion thereof.
[0071] It will be understood that changes in the details,
materials, steps and arrangements of parts which have been
described and illustrated to explain the nature of the invention
will occur to and may be made by those skilled in the art upon a
reading of this disclosure within the principles and scope of the
invention. The foregoing description illustrates the preferred
embodiments of the invention; however, concepts, as based upon the
description, may be employed in other embodiments without departing
from the scope of the invention. The invention is not otherwise
limited, except for the recitation of the claims set forth
below.
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