U.S. patent application number 14/875804 was filed with the patent office on 2016-01-28 for pre-stressed pressure device.
The applicant listed for this patent is 3K Anesthesia Innovations LLP. Invention is credited to Boris Goldman, Eric Kitain, Vladimir Koltchine, Robert Koorn.
Application Number | 20160022504 14/875804 |
Document ID | / |
Family ID | 51220883 |
Filed Date | 2016-01-28 |
United States Patent
Application |
20160022504 |
Kind Code |
A1 |
Goldman; Boris ; et
al. |
January 28, 2016 |
PRE-STRESSED PRESSURE DEVICE
Abstract
A pre-stressed pressure device for treating a wound or reducing
scarring of a skin of a patient. the pre-stressed pressure device
is composed of a pressure member having a curved state and a
non-curved state, the pressure member having an inner surface and
an outer surface. The pressure member has a central portion and
first and second end portions, the central portion having a curved
shape when the pressure member is in the curved state. The
pre-stressed pressure device also contains a substrate assembly
having a first surface side and a second surface side, the first
surface side of the substrate assembly being secured to the inner
surface of the pressure member and wherein the substrate assembly
is no shorter than the pressure member. Further included is a
treatment device connected to the second surface side of the
substrate assembly, wherein the first and second end portions of
the substrate assembly extend beyond a first and a second end of
the treatment device; and an adhesive is located on the first and
second end portions of the substrate assembly on the second surface
side of the substrate assembly for applying the pre-stressed
pressure device to the skin of the patient. The pressure member
exerts end forces directed away from the patient and a central
force directed towards the patient.
Inventors: |
Goldman; Boris; (Newtown,
CT) ; Kitain; Eric; (Armonk, NY) ; Koorn;
Robert; (Redding, CT) ; Koltchine; Vladimir;
(Redding, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
3K Anesthesia Innovations LLP |
Redding |
CT |
US |
|
|
Family ID: |
51220883 |
Appl. No.: |
14/875804 |
Filed: |
October 6, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13934600 |
Jul 3, 2013 |
|
|
|
14875804 |
|
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|
Current U.S.
Class: |
602/44 ; 602/46;
602/48; 602/53 |
Current CPC
Class: |
A61F 13/0233 20130101;
A61F 2013/00119 20130101; A61F 13/00063 20130101; A61F 13/025
20130101; A61F 2013/00217 20130101; A61B 2017/00526 20130101; A61B
17/1325 20130101; A61F 2013/0028 20130101; A61F 13/02 20130101;
A61F 13/0276 20130101; A61F 13/0206 20130101 |
International
Class: |
A61F 13/02 20060101
A61F013/02 |
Claims
1. A pressure bandage for treating a patient, the pressure bandage
comprising: a substrate assembly having a first surface side and a
second surface side, as well as first and second end portions; a
pressure member having a curved state and a non-curved state, the
pressure member having an inner surface and an outer surface, the
pressure member also comprising a central portion and first and
second end portions, the central portion having a curved shape when
the pressure member is in the curved state and the pressure member
being connected to the second side of the substrate assembly; a
treatment device mounted on a center portion of an underside of the
substrate assembly between the first and second end portions of the
substrate assembly, wherein the first and second end portions of
the substrate assembly extend beyond first and second ends of the
treatment device; an adhesive disposed on the first and second end
portions of the substrate assembly, the adhesive for securing the
substrate assembly and the pressure member to the patient, wherein
the pressure member exerts end forces directed away from the
patient and a central force directed towards the patient.
2. The pressure bandage of claim 1, wherein the center portion and
the first and second end portions of the pressure bandage have a
different thickness or a different width from one another.
3. The pressure bandage of claim 1, wherein the treatment device
comprises an absorbent pad, a silicone pad, a gauze, an
anti-bacterial agent treated pad, a coagulant agent treated pad, a
hemostatic agent treated pad, a vitamin E treated pad, an
antibiotic treated pad, an antiseptic treated pad, a botulism toxin
treated pad, or a growth factors treated pad.
4. A pre-stressed pressure device for treating a wound or reducing
scarring of a skin of a patient, the pre-stressed pressure device
comprising: a pressure member having a curved state and a
non-curved state, the pressure member having an inner surface and
an outer surface, the pressure member also comprising a central
portion and first and second end portions, the central portion
having a curved shape when the pressure member is in the curved
state; a substrate assembly having a first surface side and a
second surface side, the first surface side of the substrate
assembly being secured to the inner surface of the pressure member
and wherein the substrate assembly is no shorter than the pressure
member; a treatment device connected to the second surface side of
the substrate assembly, wherein the first and second end portions
of the substrate assembly extend beyond a first and a second end of
the treatment device; and an adhesive located on the first and
second end portions of the substrate assembly on the second surface
side of the substrate assembly for applying the pre-stressed
pressure device to the skin of the patient, wherein the pressure
member exerts end forces directed away from the patient and a
central force directed towards the patient.
5. The pre-stressed pressure device for treating a wound or reduce
reducing scarring of a skin of a patient as claimed in claim 4,
wherein the pressure member exerts a pressure ranging from 10-25 mm
Hg to the wound of a patient when secured to the wound in the
non-curved state.
6. The pre-stressed pressure device of claim 4, wherein the
substrate assembly comprises a woven cloth, a cotton, a natural
and/or artificial fibers, a natural and/or gel materials, a natural
or artificial foamed rubber and/or a vinyl material, or a
combination thereof.
7. The pre-stressed pressure device of claim 4, wherein the
pressure member is pre-stressed and is curved in the central
portion and flat in the first and second end portions.
8. The pre-stressed pressure device of claim 4, wherein the
pressure member has less curvature at the first and second end of
the pressure member than at the center of the central portion of
the pressure member.
9. The pre-stressed pressure device of claim 4, wherein the
treatment device comprises a silicone pad, a gauze, an
anti-bacterial agent treated pad, a coagulant agent treated pad, a
hemostatic agent treated pad, a vitamin E treated pad, an
antibiotic treated pad, an antiseptic treated pad, a botulism toxin
treated pad, or a growth factors treated pad.
10. The pre-stressed pressure device of claim 4, wherein the
pressure member has a greater thickness in the first and second end
portions than in the central portion.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a division of U.S. patent
application Ser. No. 13/934,600, filed Jul. 3, 2013, entitled
"PRE-STRESSED PRESSURE DEVICE", which is currently pending.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to a device and system for treating a
patient. Specifically, the invention relates to a pre-stressed
pressure device that applies pressure to a wound and/or scar to
promote healing and reduce the appearance of scars and to a system
for making and using the pre-stressed pressure device.
[0004] 2. Description of the Related Art
[0005] Applying pressure to a patient's wound is beneficial because
pressure provides immediate hemostasis and decreases swelling and
bruising associated with the wound. An added benefit for traumatic
or surgical wounds that require sutures is diminished swelling
resulting in less tension across the suture lines. This facilitates
healing and improves the quality of the final scar by decreasing
suture marks and irregularities formed in the skin as the tissue
surrounding the wound heals.
[0006] Wounds may take many forms. Herein, "wound" is intended to
be as broadly inclusive as possible and means one or more injuries
to at least the skin of a person. Wound may mean cuts and
lacerations that are self-treated by a patient. It may also mean
serious wounds caused by traumatic injuries that are treated in a
medical setting; wounds caused by surgery; or vascular cutaneous
puncture sites such as intravenous catheter, arterial catheter, or
the like.
[0007] As wounds heal, applying pressure prevents scarring. The
skin at any site of the body comprises an intrinsic tension that
stretches the marginal area of the skin surrounding the wound. The
actual amount of tension may vary, depending upon the person, age,
skin type, and wound location. Pre-existing skin conditions, such
as scarring, may also affect the intrinsic tension. During the
intermediate phase of a wound healing process (between 2 weeks and
12 weeks), the edges of a healing incision or wound, are pulled in
different directions by surrounding skin, causing formation of the
scar tissue.
[0008] Even after scarring has formed, applying pressure is an
integral component of a scar reduction regimen. Typically, a
silicone gel sheet is fastened to a patient using a bandage wrapped
tightly around the patient's limb or torso. When combined with
glucocorticoid steroids, the result reduces the appearance of
hypertrophic (thick) scars.
[0009] Herein, "scar" and/or "scarring" is intended to be as
broadly inclusive as possible and means at last one or more
temporary or permanent deformations of any part of the skin due to
injury to the skin.
[0010] Unfortunately, to date, the various technologies available
for providing pressure on a wound and/or scar require bulky or
impractical devices. Thus, what is desired is a wound and scar
treatment that provides pressure to a wound and/or scar and that is
compact and a system for making and using that treatment.
SUMMARY OF THE INVENTION
[0011] These and other objectives are met by the present
invention.
[0012] In accordance with one or more embodiments of the present
invention, a pre-stressed pressure device is preferably configured
as a pressure bandage for treating a wound or to reduce scarring of
the skin of a patient. The pressure bandage includes a substrate
assembly having a first surface, a pressure member having a curve
in a central portion, the pressure member being secured to the
substrate assembly; a treatment device for exerting a pressure on
the wound or the scarring, the treatment device being connected to
a first area of the first surface; and an adhesive for applying the
pressure bandage to the skin, the adhesive being disposed on a
second area of the first surface, the first and second areas being
non-overlapping.
[0013] In accordance with one or more embodiments of the present
invention, a pre-stressed pressure device is preferably configured
as a pressure bandage for treating a patient. The pressure bandage
includes a substrate assembly, a treatment device mounted on the
substrate assembly, an adhesive disposed on the substrate assembly,
the adhesive for securing the pressure bandage to the patient, and
a pressure member secured to the substrate assembly. Therein, the
pressure member is in a substantially curved state when the
pressure bandage is not secured to the patient.
[0014] The pressure member includes a center portion and an end
portion, which have a different thickness or a different width from
each other.
[0015] The pressure member includes a plurality of disconnected
portions disposed in a plurality of planes.
[0016] A system for treating a wound or scarring of a patient
includes a pressure bandage comprising a pressure member having a
pre-tension, a 3D printer for printing the pressure member, and a
heater for selective heating an area of the pressure member to
impart the pre-tension.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1a is a schematic plan view of a wound and scar being
treated by the present invention.
[0018] FIG. 1b is a cross-sectional area view of the wound of FIG.
1a being treated by the present invention and a pressure diagram
associated with the present invention.
[0019] FIG. 2a is a top plan view of a pre-stressed pressure device
that is configured as a bandage in accordance with one or more
embodiments of the present invention.
[0020] FIG. 2b is a bottom plan view of the bandage of FIG. 2a.
[0021] FIG. 2c is a longitudinal side view of the bandage of FIG.
2b.
[0022] FIG. 2d is a first transverse cross-sectional view of the
bandage of FIG. 2a.
[0023] FIG. 2e is a second transverse cross-sectional view of the
bandage of FIG. 2a.
[0024] FIG. 2f is a longitudinal cross-sectional view of the
bandage of FIG. 2a.
[0025] FIG. 3a is a schematic view of the bandage of the present
invention of FIG. 2a prior to being applied to the wound of FIGS.
1a and 1b.
[0026] FIG. 3b is a detail view of the treatment device of the
present invention of FIG. 2a after being applied to the wound of
FIGS. 1a and 1b.
[0027] FIG. 3c is a schematic view of the present invention of FIG.
2a after being applied to the wound of FIGS. 1a and 1b and pressure
diagrams associated with the present invention.
[0028] FIG. 4a is a longitudinal cross-sectional view of the
pressure member of the bandage of FIG. 2a.
[0029] FIG. 4b is a first transverse cross-sectional view of the
pressure member of FIG. 4a.
[0030] FIG. 4c is a second transverse cross-sectional view of the
pressure member of FIG. 4a.
[0031] FIG. 5a is a top plan view of a bandage in accordance with
one or more embodiments of the present invention.
[0032] FIG. 5b is a bottom plan view of the bandage of FIG. 5a.
[0033] FIG. 5c is a longitudinal side view of the bandage of FIG.
5b.
[0034] FIG. 6a is a top plan view of a bandage in accordance with
one or more embodiments of the present invention.
[0035] FIG. 6b is a bottom plan view of the bandage of FIG. 6a.
[0036] FIG. 6c is a longitudinal side view of the bandage of FIG.
6b.
[0037] FIG. 7a is a plan view of a pressure member in accordance
with one or more embodiments of the present invention.
[0038] FIG. 7b is a cross-sectional view of the pressure member of
FIG. 7a.
[0039] FIG. 7c is a first alternate cross-sectional view of the
pressure member of FIG. 7a.
[0040] FIG. 7d is a second alternate cross-sectional view of the
pressure member of FIG. 7a.
[0041] FIG. 7e is a plan view of a pressure member in accordance
with one or more embodiments of the present invention.
[0042] FIG. 7f is a plan view of a pressure member in accordance
with one or more embodiments of the present invention.
[0043] FIG. 8a is a plan view of a pressure member in accordance
with one or more embodiments of the present invention.
[0044] FIG. 8b is a longitudinal cross-sectional view of the
pressure member of FIG. 8a.
[0045] FIG. 8c is an alternate longitudinal cross-sectional view of
the pressure member of FIG. 8a.
[0046] FIG. 9a is a plan view of a pressure member in accordance
with one or more embodiments of the present invention.
[0047] FIG. 9b is a plan view of a pressure member in accordance
with one or more embodiments of the present invention.
[0048] FIG. 9c is a longitudinal cross-sectional view of the
pressure member of FIG. 9b.
[0049] FIGS. 10a-10c and 11a-11c are, respectively, plan, side, and
side on skin views of a bandage in accordance with one or more
embodiments of the present invention.
[0050] FIG. 12a is a longitudinal side view of a pre-stressed
pressure device that is configured as a stress guard prior to being
applied to a patient in accordance with one or more embodiments of
the present invention.
[0051] FIG. 12b is a longitudinal side view of the stress guard of
FIG. 12a applied to a patient when initially applied to an open
incision site.
[0052] FIG. 12c is a longitudinal side view of the stress guard of
FIG. 12a after being stressed.
[0053] FIG. 12d is a first detail view of the stress guard of FIG.
12a.
[0054] FIG. 12e is a second detail view of the stress guard of FIG.
12a.
[0055] FIG. 13 is a diagram illustrating a treatment system for
making a pre-stressed pressure device for treating a wound and/or
reducing scarring in accordance with one or more embodiments of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0056] The following detailed description is of the best mode or
modes of the invention presently contemplated. Such description is
not intended to be understood in a limiting sense, but to be an
example of the invention presented solely for illustration thereof,
and by reference to which in connection with the following
description and the accompanying drawings one skilled in the art
may be advised of the advantages and construction of the invention.
In the various views of the drawings, like reference characters
designate like or similar parts.
[0057] FIG. 1a is a schematic plan of a wound and scar being
treated by the present invention. FIG. 1b is a cross-sectional area
of the wound of FIG. 1a being treated by the present invention and
a pressure diagram associated with the present invention.
[0058] Therein, a patient 100 has sustained a wound 110 as is
commonly understood and at least as defined in the Description of
the Related Art. The wound 110 has a wound area 112 that is
determined by the type and cause of the wound and a treatment area
114. The treatment area extends from a regularized margin 116 of
the wound to encompass the wound and an area most likely to be
scarred by scarring 118, such as hypertrophic, as determined by a
patient, but preferably by a qualified medical practitioner. A
"regularized margin" herein means a theoretical margin of the wound
that extends in a regular geometric pattern of an ellipse or a
circle about the wound and touches the furthest extent of the
actual margin of the wound at at least three points. To treat the
wound 110 and prevent likely scarring 118, a pressure P, shown as
exemplary pressure 190 in the pressure diagram of FIG. 1b, is
applied by a treatment device (not shown) on at least the treatment
area 114 using a pressure bandage 10.
[0059] It should be understood that the present invention may also
be applied to only a scar. Therein, the wound area 112 is nil and
the treatment area 114 extends to encompass the area scarred by
scarring 118, such as hypertrophic scarring, as determined by a
patient, but preferably by a qualified medical practitioner. To
treat scarring 118, pressure P, is applied by a treatment device on
at least the treatment area 114 using a pressure bandage 10.
[0060] Pressure P is preferably non-uniform and is greater over the
treatment area 114 than in other areas where the pressure bandage
is applied. The particular diagrammatic shape and/or amount of
pressure P are dependent on the shape of a pressure member in plan
view, thickness, and amount, i.e., degree of pre-stressing.
[0061] FIG. 2a is a top plan view of a pre-stressed pressure device
that is configured as a bandage in accordance with one or more
embodiments of the present invention. FIG. 2b is a bottom plan view
of the bandage of FIG. 2a. FIG. 2c is a longitudinal side view of
the bandage of FIG. 2b. FIG. 2d is a first transverse
cross-sectional view of the bandage of FIG. 2a. FIG. 2e is a second
transverse cross-sectional view of the bandage of FIG. 2a. FIG. 2f
is a longitudinal cross-sectional view of the bandage of FIG.
2a.
[0062] FIG. 3a is a schematic view of the bandage of the present
invention of FIG. 2a prior to being applied to the wound of FIGS.
1a and 1b. FIG. 3b is a detail view of the treatment device of the
present invention of FIG. 2a after being applied to the wound of
FIGS. 1a and 1b. FIG. 3c is a schematic view of the present
invention of FIG. 2a after being applied to the wound of FIGS. 1a
and 1b and pressure diagrams associated with the present
invention.
[0063] FIG. 4a is a longitudinal cross-sectional view of the
pressure member of the bandage of FIG. 2a. FIG. 4b is a first
transverse cross-sectional view of the pressure member of FIG. 4a.
FIG. 4c is a second transverse cross-sectional view of the pressure
member of FIG. 4a.
[0064] In accordance with one or more embodiments of the present
invention, a pre-stressed pressure device is configured as a
pressure bandage 10. The pressure bandage 10 is preferably used for
treating the wound 110 and comprises a pressure member 14, a
substrate assembly 16, and a treatment device 22 joined to the
substrate assembly. The pressure member 14 is secured to the
substrate assembly 16 and applies a force to the treatment device
22. In turn, the treatment device 22 applies pressure P, i.e., the
pressure 190, within at least the treatment area 114 of patient 100
to promote healing and/or reduce scarring when the bandage 10 is
secured to the skin of the patient 100.
[0065] The pressure member 14 comprises one or more layers of one
or more pressure materials.
[0066] A pressure material may be any suitable material that is
elastic and capable of holding an initial non-flat shape,
preferably a curved shape. However, preferably, the pressure
material is a polymer material. More preferably, the pressure
material is selected from the group of polyvinyl chloride (PVC),
acrylonitrile butadiene styrene (ABS); nylon polymers including
polyamide 6, polyamide 66, homopolymers, and co-polymers; polyester
resin; low-density polyethylene terephthalate (PET); low-density
polyethylene, high-density polystyrene; high-density polyethylene;
and rubberized and/or plasticized PVC.
[0067] The pressure member 14 comprises, but not necessarily, a
generally rectangular shape in plan view having end portions 14a
(each defined as being generally, but not necessarily, the
one-third end area in plan view of the pressure member) spaced
distal from a central portion 14b (defined as being generally, but
not necessarily, the center one third area in plan view of the
pressure member) and has a thickness 14c. The thickness 14c is
preferably sufficient to prevent the longitudinal edges of the
pressure member 14 from curling inwards towards the longitudinal
centerline of the pressure member. That is, the thickness 14c is
chosen such that the pressure member remains rigid in a
cross-section perpendicular to the longitudinal centerline of the
pressure member.
[0068] Therein, the thickness 14c may be varied as needed for the
specific embodiment of the bandage 10 and may be non-uniform and
variable in thickness across the width and/or along the length of
the pressure member 14. The thickness preferably also provides the
bandage 10 with sufficient load carrying capacity to achieve the
desired pressure strains needed for the therapeutic effect on the
wound 110 and/or the scarring 118. The thickness 14c of the
pressure member 14 may be tapered near the edges for added comfort
and/or safety of use.
[0069] The pressure member 14 normally has a curved shape in at
least part of the central portion 14b while the end portions 14a
are straight. In other words, the pressure member 14 has a normally
curved state 15a, i.e., first state. This state occurs prior to the
pressure bandage 10 being applied to the skin of the user.
[0070] The curved shape in at least part of the central portion 14b
may be achieved by casting, extruding, and/or forming central
portion to be curved. Therein, the central portion 14b may have any
suitable curve while the end portions 14a are straight.
[0071] The curved shape may also be made by pre-stressing the
pressure member in a pre-stressed area 14d (FIG. 4a), such as being
heat-treated. Therein, the pre-stressed area 14d is preferably
disposed in the central portion 14b. In the pre-stressed area, the
pressure member has been stressed increasing the compression side
14e, moving the neutral axis 14f in the pre-stressed area 14d, and
causing the tension side 14g to be reduced.
[0072] In the curved state 15a, the pressure member 14 is curved in
the pre-stressed area 14d, i.e., at least part or all of the
central portion 14b, while the end portions 14a are straight.
Therein, the end portions 14a are preferably, but not necessarily,
equidistant from the central portion 14b in lateral and offset
directions and are curved in the same direction. When the pressure
member 14 is in the curved state 15a, the bandage 10 generally
follows the same curved contour as the pressure member 14 and also
is in the curved state 15a.
[0073] When the bandage 10 has been applied to the patient 100, the
pressure member 14 will be in a non-curved, substantially
non-curved state 15b, i.e., second state. When the pressure member
14 is in substantially the non-curved state 15b, the bandage 10
generally follows the same contour as the pressure member 14 and
also is in substantially the non-curved state 15b. The non-curved
state 15b may be a flat state or contour, and/or may be one where
the pressure member, i.e., pressure bandage, follows the contour of
the skin.
[0074] In the substantially non-curved state 15b, the pressure
member 14 exerts a force F1. The force F1 has end forces F1a and
F1b directed away from the patient 100 and a central force F1c
directed toward the patient 100 and forcing the treatment device 22
onto at least the treatment area 114. That is, when the pressure
member 14 is straightened, the region of the pressure member 14
that has not been pre-stressed will pull upwards with forces F1a
and F1b in an evenly dispersed manner while the force F1c in the
region that has been pre-stressed, i.e., the central portion 14b,
will be applied downward with a force equal to the sum of the
forces F1a and F1b. The force F1c will be at maximum at the center
the pressure member vary along the central portion 14b.
[0075] Advantageously, the pressure material may be pre-stressed to
a predetermined amount, and thus, the amount of curvature may be
selectively predetermined to the pressure member 14. In turn, by
varying the curvature, the central portion 14b can be predetermined
to exert a specific force F1c on the wound 110. In addition or in
the alternative, the shape and/or the thickness 14c of the pressure
member may be selected, as taught further herein, to provide
further predetermined refinement of the force F1c. For example, by
increasing the size of the edge portions 14a relative to the
central portion 14b, a greater force F1c will be generated. The
force F1c is transferred as pressure to the patient via the
treatment device, since pressure is force per unit area.
[0076] Therein, increasing the force F1c will yield an increase in
pressure applied to at least the treatment area 114 via the
treatment device.
[0077] The pressure member 14 may have a thickness of 100 microns
to at least 1 mm, but preferably with a range of about 220 microns
to about 500 microns, or more preferably 300 microns to 400
microns.
[0078] The substrate assembly 16 comprises at least two substrate
members 18a, 18b and an adhesive 20a applied in an adhesive area
20b of the substrate assembly 16. Substrate members 18a, 18b may be
made of any suitable material 19a that is durable, stretchable, and
resiliently flexible as is known in the art for adhesive
bandages.
[0079] However, preferably, each substrate member, when made of a
single layer, comprises or consists of a material 19a and, when
made of a multilayer structure, comprises a covering made of a
material 19a and one or more support layers made of a material 19b.
The material 19a used may be made entirely of or comprise a woven
material such as cloth in any suitable weave strength and may
metal-detectable fabric, such as metal fibers, to permit the use of
the bandage 10 in food service and/or processing industry. The
material 19a may also be a light woven material for comfort or a
heavy woven material for protection. The material may be chosen
such that it is air permeable to permit air to access the wound 110
and/or the treatment area 114.
[0080] The material 19a may also be made entirely of or comprise a
plastic material or rubber material as is known in the art for
adhesive bandages due to their excellent stretchability, costs,
and/or wearability.
[0081] The substrate members 18a and 18b may also comprise a
multilayer structure. Therein, one or more material layers comprise
or consist of a material 19b, which may be cotton, artificial
and/or natural fibers, artificial and/or natural gel materials,
natural or artificial foamed rubber and/or vinyl, or a combination
thereof may be added to the covering.
[0082] The adhesive 20a may be one or more suitable
pressure-sensitive adhesives as is known in the art for adhesive
bandages. Due to their excellent adhesion strength, usability,
costs, and/or length of use, the adhesive 20a is preferably
selected from the group of acrylic, silicone, butyl rubber,
nitrile, styrene block copolymers (SBC), ethylene-vinyl acetate
(EVA), or a combination thereof. In addition or in the alternative,
the adhesive 20a may be a polyacrylate-based,
polyisobutylene-based, and/or silicone-based pressure-sensitive
adhesive; or a synthetic rubber, acrylic, hydrocolloid, or a like
compound adhesive. In addition or in the alternative, the adhesive
20a may also be a light-curable or heat-curable adhesive.
[0083] Preferably, regardless of type, the adhesive 20a comprises a
T-peel release force of in the range of 0.45 N/cm to at least 19
N/cm. Therein, the T-peel release force and blunt probe tack force
of pressure-sensitive adhesives is in accordance with ASTM D1876
and ASTM D2979 or other appropriate methods.
[0084] The adhesive 20a is applied in the adhesive area 20b to the
substrate assembly. Therein, the adhesive area 20b is preferably a
marginal area of the substrate assembly 16 that surrounds the
treatment device 22 and is non-overlapping with the treatment
device 22, which is also attached to the substrate assembly 16, to
provide maximum adhesion to the skin of the patient 100.
[0085] The substrate members 18a and 18b are preferably sized
similarly and define the maximum extent of both the bandage 10 and
the substrate assembly 16 in plan view. In accordance with one or
more embodiments of the present invention, a pressure bandage 10
exerts a pressure P having a pressure component 190 and one or more
pressure components 191. The pressure component 190 is the result
of the force F1 and F2 and each pressure component 191 is the
result of only the force F2.
[0086] The minimum size of the substrate assembly 16 is determined
by the size of the adhesive area 20b needed for an adhesive 20a to
create the force F2 to overcome the forces F1a and F1b of the
pressure member and to adhere the bandage 10 to the skin with
sufficient forces to overcome unintended removal of the bandage 10
from the skin. Thus, when the bandage 10 has been applied to the
patient 100, at least the force F1c is exerted onto the treatment
device 22, in turn, creating the pressure 190 onto at least the
treatment area 114.
[0087] In accordance with one or more other embodiments of the
present invention, the size of the substrate assembly 16 may be
determined by the size of adhesive area 20b needed for the adhesive
20a to create the force F2 to overcome at least the forces F1a and
F1b of the pressure member, to adhere the bandage 10 the skin of
the patient with sufficient forces to overcome unintended removal
of the bandage 10 from the skin, and, further to add to the
pressure applied by the pressure member 14 to the treatment device.
Thus, preferably, the adhesive placed in the adhesive area 20b
exerts a force F2 onto the substrate assembly 16, or more
specifically, to the pressure member 14 to prevent the pressure
member from removing the bandage from the skin of the patient.
Thus, when the bandage 10 has been applied to the patient 100, the
force F1c and a portion of the force F2 is exerted onto the
treatment device 22, in turn, creating the pressure 190 onto at
least the treatment area 114.
[0088] The pressure member 14 may be disposed in the substrate
assembly 16 by being embedded or sandwiched between the substrate
members 18a and 18b and additionally may be secured as described
below. However, the pressure member 14 may also be disposed or
embedded solely within one of the substrate members or may be
embedded such that a longitudinally-extending or
laterally-extending portion of the pressure member is embedded
solely in one substrate member. The other longitudinally-extending
or laterally-extending portion of the pressure member is then
embedded in the other substrate member or when three or more
substrate members are present in one or more of the other substrate
members.
[0089] In addition, the pressure member 14 may be joined to, joined
with, disposed in, or disposed on, or embedded in the substrate
using an adhesive, sonic welding, heating, stamping, or any other
suitable means that aids in avoiding unintended movement of the
pressure member 14 relative to the substrate assembly 16.
[0090] Regardless of how the pressure member 14 is disposed in the
substrate assembly 16, the substrate assembly 16 comprises a
marginal edge area 18c in plan view between a perimeter of the
pressure member and a perimeter of the substrate assembly. The
marginal edge area 18c also advantageously aids in keeping the
pressure member 14 securely located relative to the substrate
assembly 16.
[0091] The substrate members 18a and 18b may be secured to each
other by using an adhesive, sonic welding, heating, stamping, or
any other suitable means that aids in avoiding unintended movement
of the substrate members relative to each other. Moreover, the
perimeter and/or a perimeter margin of the substrate assembly 16
may have a finished and reduced thickness relative to other
portions of the substrate assembly 16 by crimping, flattening,
sonically welding, and/or stamping the perimeters of the substrate
members 18a, 18b. This advantageously prevents the unintended
separation of the substrate members from each other.
[0092] The treatment device 22 is joined to the substrate assembly
16 using an adhesive, sonic welding, heating, stamping, or any
other suitable means that aids in avoiding unintended dislocation
of the treatment device relative to the substrate assembly.
[0093] In accordance with one embodiment of the present invention,
the treatment device 22 may comprise or consist of an absorbent pad
made from cotton gauze or fabric, but the treatment device 22 may
also comprise or consist of an absorbent material impregnated with
one or more anti-bacterial agents or substances generally known in
the art.
[0094] The treatment device 22 may also may comprise or consist of
one or more scar reducing materials such as silicone formed into a
pad.
[0095] The treatment device 22 may also comprise or consist of a
combination pad wherein a skin proximal layer is an absorbent
material joined to a skin distal layer made of one or more scar
reducing materials. This advantageously immediately permits
hemostasis and initiates a regimen of scar reduction.
[0096] In accordance with one or more embodiments of the present
invention, the treatment device 22 for a wound may comprise an
absorbent material and may have a thickness of approximately
220-500 microns at a center of the pad for maximum comfort and
absorbency while marinating a clinically suitable pressure on the
wound. The treatment device 22 may have a silicone pad for scar
reduction and may achieve a pressure of 10 to 25 mm Hg, i.e., 10 to
25 Torr, of pressure under the pad for a clinically suitable
pressure to reduce scarring.
[0097] In accordance with one or more embodiments of the present
invention, the treatment device 22 may comprise one or more
therapeutic agents beneficial to wound healing and/or scar
reduction that may be disposed in or on the absorbent pad of the
treatment device, but also packaged with bandage 10 in a kit. For
example, therapeutic agents may be Vitamin E and/or one or more
hemostatic and/or coagulative agents. Hemostatic and/or coagulative
agents may comprise epinephrine, calcium alginate, calcium-loaded
zeolite, cellulose, microfibrillar collagen, fibrinogen,
glucosamine, thrombin, coagulation factors (e.g. II, VI, VII, X,
XIII, VWF), procoagulants, antifibrinolytics (e.g. epsilon
aminocaproic acid), and/or similar compounds.
[0098] A therapeutic agent may also be an antibiotic disposed in or
on the treatment device, but also packaged with the bandage 10 in a
kit. A therapeutic agent may be, but is not limited to,
cephalosporins, polymyxin B sulfate, bacitracin, neomycin,
polysporin), antiseptics (such as iodine solutions, silver
sulfadiazine, chlorhexidine) and/or other treatments (e.g. botulism
toxin, growth factors).
[0099] The bandage 10 preferably includes a pair of protective
sheets disposed on the side proximal to the treatment device as are
generally known in the art.
[0100] The bandage 10 may also be packaged in a sterile packaging
that is easily removable by peeling two protecting sheets apart as
is generally known in the art.
[0101] Since the bandage 10 generally follows the same curved
contour as the pressure member 14 in the curved state 15a, the
curved shape of the bandage, advantageously, permits nested
packaging.
[0102] A plurality of the bandages 10 may be packaged to have
treatment regimen starting with control of the wound using the
bandages having treatment devices consisting of absorbent pads to
bandages having treatment devices consisting of combination pads
and ending with bandages having treatment devices having only scar
reducing materials.
[0103] In accordance with one or more embodiments of the present
invention, the bandage 10 may also be used for treatment of
skin-related conditions such as skin injuries, including for
example, incisions, acute or chronic wounds, ulcers, and
venopuncture areas; preventing or reducing the incidence of wound
infections, swelling and hematoma formation; treatment of skin
irritation and sensitivity, skin paresthesia, allodynia,
dermatitis, warts, rashes, acne, and psoriasis; management of
arteriovenous malformations; treatment or improvement of wrinkles,
scars, stretch marks or other skin irregularities; and/or
delivering a drug to the skin or through the skin.
[0104] In accordance with one or more embodiments of the present
invention, the bandage 10 further comprises, in any convenient
location, one or more designs, logos, advertisements, treatment
information, contact names and numbers, and/or marketing
information.
[0105] In accordance with one or more embodiments of the present
invention, the bandage 10, as for example, illustrated in FIGS.
2a-2f and 3a-3c, comprises a length 11a of approximately 50 mm to
190 mm and a width 11b of 22 mm to 100 mm. The bandage further
comprises a thickness 11c in the range of 100 microns to at least 1
mm. Greater thicknesses may be possible depending on the thickness
of the pressure member and generally vary between 1 mm to 3 mm.
[0106] Other bandages 10 may be suitably dimensioned in accordance
with needs associated with a wound 110 or scarring 118.
[0107] FIG. 5a is a top plan view of a bandage in accordance with
one or more embodiments of the present invention. FIG. 5b is a
bottom plan view of the bandage of FIG. 5a. FIG. 5c is a
longitudinal side view of the bandage of FIG. 5b.
[0108] In accordance with one or more embodiments of the present
invention, a bandage 10a is constructed similarly to bandage 10
except that the substrate assembly 16 has been replaced with a
substrate assembly 16a, which comprises a single substrate member
18a. The single substrate member, preferably, comprises one or more
layers made of material 19b and at least one covering made of
material 19a. However, preferably, two coverings made of material
19a sandwich the one or more layer made of material 19b. Therein,
the pressure member 14 may be disposed within the single substrate
member in a manner taught above.
[0109] The substrate member 18a may also consist of a single
structural layer made of material 19a. Then, the pressure member 14
is joined to an underside of the substrate member 18a, i.e., the
substrate assembly 16, using an adhesive, sonic welding, heating,
stamping, or any other suitable means that aids in avoiding
unintended removal of the pressure member.
[0110] The treatment device 22 is then secured directly to the
pressure member by an adhesive, sonic welding, heating, stamping,
or any other suitable means that aids in avoiding unintended
movement of the treatment device relative to pressure member.
[0111] Thus, the adhesive area 20b is disposed directly on the
underside of the substrate member 18a and may also be disposed at
least partially on an area of the pressure member 14 that is not
covered by the treatment device 22.
[0112] Advantageously, the bandage 10a provides a simple and cost
effective construction.
[0113] FIG. 6a is a top plan view of a bandage in accordance with
one or more embodiments of the present invention. FIG. 6b is a
bottom plan view of the bandage of FIG. 6a. FIG. 6c is a
longitudinal side view of the bandage of FIG. 6b.
[0114] In accordance with one or more embodiments of the present
invention, a bandage 10b is constructed similarly to bandage 10
except that the pressure member 14 is secured to the substrate
assembly 16 on a side opposite to a side to which the treatment
device 22 are secured.
[0115] Therein, the pressure member 14 is secured to a first side
16b of the substrate assembly 16. The substrate assembly 16 may be
any substrate assembly as taught above, but, preferably, the
substrate assembly 16 comprises a single substrate member 18a that,
in turn, consists of a single structural layer made of material
19a. The pressure member is secured to the first side by an
adhesive, sonic welding, heating, stamping, or any other suitable
means that aids in avoiding unintended movement of the pressure
member relative to the substrate assembly.
[0116] The treatment device 22 is secured directly to a second side
16c of the substrate assembly 16 by an adhesive, sonic welding,
heating, stamping, or any other suitable means that aids in
avoiding unintended movement of the treatment device relative to
pressure member.
[0117] The adhesive area 20b is disposed directly on the underside
of the substrate member 18a, i.e., substrate assembly 16, in an
area not covered by the treatment device 22.
[0118] FIG. 7a is a plan view of a pressure member in accordance
with one or more embodiments of the present invention. FIG. 7b is a
cross-sectional view of the pressure member of FIG. 7a. FIG. 7c is
a first alternate cross-sectional view of the pressure member of
FIG. 7a. FIG. 7d is a second alternate cross-sectional view of the
pressure member of FIG. 7a.
[0119] Therein, a pressure member 202 is substantially identical to
the pressure member 14 and may be used in any of the bandages
taught above. However, the pressure member 202 comprises end
portions 202a, which correspond to end portions 14a, that are wider
laterally than central portion 202b, which corresponds to the
central portion 14b. Advantageously, the configuration permits
increasing the forces F1a and F1b and placing the force F1c over a
smaller surface area. Since pressure is the force per unit area,
the force F1c will thus be able to increase pressure the treatment
device by concentrating the pressure over a smaller area.
[0120] In addition or in the alternative, the pressure member 202
comprises ridges 202c that may be squared, rounded, or peaked and
aid in increasing the amount of pre-tensioning possible and
increasing the force F1c.
[0121] FIG. 7e is a plan view of a pressure member in accordance
with one or more embodiments of the present invention. Therein, a
pressure member 204 is substantially identical to pressure member
14 and may be used in any of the bandages taught above. However,
pressure member 204 comprises end portions 204a, which correspond
to end portions 14a, that are wider laterally than the central
portion 204b, which corresponds to central portion 14b. End
portions 204a include one or more indentations 204c, which permits
the pressure member 204 to be more flexible at the end portions and
be fitted in unusual anatomical situations to a patient.
[0122] FIG. 7f is a plan view of a pressure member in accordance
with one or more embodiments of the present invention. Therein, a
pressure member 206 is substantially identical to pressure member
14 and may be used in any of the bandages taught above. However,
the pressure member 206 comprises end portions 206a and central
portions 206b, all of which have been widened, but have portions
that connect them and that are not as wide as the portions 206a and
206b.
[0123] FIG. 8a is a plan view of a pressure member in accordance
with one or more embodiments of the present invention. FIG. 8b is a
longitudinal cross-sectional view of the pressure member of FIG.
8a. FIG. 8c is an alternate longitudinal cross-sectional view of
the pressure member of FIG. 8a.
[0124] Therein, a pressure member 208 is substantially identical to
pressure member 14 and may be used in any of the bandages taught
above. However, the pressure member 208 comprises end portions
208a, which correspond to end portions 14a, that are wider
laterally than central portion 208b, which corresponds to central
portion 14b. End members 208a may also have a greater thickness
than central portion 208b. The difference in thickness may be
distributed relative to one or both sides of the central portion.
Advantageously, the configuration permits increasing forces F1a and
F1b and placing force F1c over a smaller surface area. Since
pressure is the force per unit area, force F1c will thus be able to
increase pressure the treatment device by concentrating the
pressure over a smaller area.
[0125] FIG. 9a is a plan view of a pressure member in accordance
with one or more embodiments of the present invention. FIG. 9b is a
plan view of a pressure member in accordance with one or more
embodiments of the present invention. FIG. 9c is a longitudinal
cross-sectional view of the pressure member of FIG. 9b.
[0126] Therein, a pressure member 210 is substantially identical to
pressure member 14 and may be used in any of the bandages taught
above. However, the pressure member 210 comprises a plurality of
disconnected strips 210a that may be arranged in one or more
planes. This permits the pressure member to be more flexible.
[0127] The pressure member 210 may also comprise a plurality of
disconnected strips 210a and 210b that may be arranged in one or
more planes and/or may be stacked on top of each other.
[0128] The strips 210b are preferably, but not necessarily,
arranged at the end portions of the pressure member 210 causing the
pressure member to have a greater thickness at one or more end
portions than a central portion. This permits the pressure member
to be more flexible as well as increasing the forces F1a and F1b
and placing the force F1c over a smaller surface area. Since
pressure is the force per unit area, the force F1c will thus be
able to increase pressure on the treatment device.
[0129] FIGS. 10a-10c and 11a-11c are, respectively, plan, side, and
side on skin views of a bandage in accordance with one or more
embodiments of the present invention. Therein, a bandage 10d or 10e
comprises a plurality of pressure members 14 that are arranged to
overlap and/or have a woven configuration. This permits the
bandages 10d and 10e to conform in not flat situations, such as the
antecubital fossa.
[0130] FIG. 12a is a longitudinal side view of a pre-stressed
pressure device is configured as a stress guard prior to being
applied to a patient in accordance with one or more embodiments of
the present invention. FIG. 12b is a longitudinal side view of the
stress guard of FIG. 12a applied to a patient when initially
applied to an open incision site. FIG. 12c is a longitudinal side
view of the stress guard of FIG. 12a after being stressed. FIG. 12d
is a first detail view of the stress guard of FIG. 12a. FIG. 12e is
a second detail of the stress guard of FIG. 12a.
[0131] A pre-stressed pressure device is configured as a stress
guard 40. Returning to FIG. 1a, the stress guard 40 is preferably
used to treat the wound 110, which may be a wound caused by a
surgical incision, and prevent scarring associated with the wound.
Therein, the wound 110 typically will be sutured, and, thus, the
wound area 112 is nil and the treatment area 114 extends to
encompass the area scarred by scarring 118. To treat the wound 110
and prevent likely scarring 118, a pressure 192, i.e., a stress 192
is applied by a treatment device on at least a portion of the
treatment area 114 using the stress guard 40.
[0132] Therein, the stress guard 40 is preferably pre-stressed with
a curve designed to maximize inward force while applied to the skin
with preferably a peelable adhesive disposed on end portions of the
stress guard but not on the central portion. The stress guard can
be manually strained and applied flat to the skin. The stress at
the wound site may be reduced to the levels below that experienced
by normal skin.
[0133] In accordance with one or more embodiments of the present
invention, the stress guard 40 comprises a pressure member 44,
which exerts pressure 192 on the wound 110 to close the wound area
112, if open, and/or relieve stress in the wound area 112, and an
adhesive 46a applied in one or more adhesive areas 46b.
[0134] The pressure member 44 comprises one or more layers of one
or more pressure materials. A pressure material may be any suitable
material that is elastic and capable of holding an initial non-flat
shape, preferably a curved shape. However, preferably, the pressure
material is a polymer material. More preferably, the pressure
material is selected from the group of polyvinyl chloride (PVC),
acrylonitrile butadiene styrene (ABS); nylon polymers including
polyamide 6, polyamide 66, homopolymers, and co-polymers; polyester
resin; low-density polyethylene terephthalate (PET); low-density
polyethylene, high-density polystyrene; high-density polyethylene;
and rubberized and/or plasticized PVC.
[0135] The pressure member 44 comprises, but not necessarily, a
generally rectangular shape in plan view having end portions 44a
(each defined as being generally, but not necessarily, the
one-third end area in side view of the pressure member) spaced
distal from a central portion 44b (defined as being generally, but
not necessarily, the center one third area in side view of the
pressure member) and has a thickness 44c. The thickness 44c is
preferably sufficient to prevent the longitudinal edges of the
pressure member 44 from curling inwards towards a longitudinal
centerline of the pressure member. That is, the thickness 44c is
chosen such that the pressure member remains rigid in a
cross-section perpendicular to the longitudinal centerline of the
pressure member.
[0136] Therein, the thickness 44c may be varied as needed for the
specific embodiment of the stress guard 40 and may be non-uniform
and variable in thickness across the width and/or along the length
of the pressure member 44. The thickness preferably also provides
stress guard with sufficient load carrying capacity to achieve the
desired pressure 192. The thickness 44c of the pressure member 44
may be tapered near the edges for added comfort and/or safety of
use.
[0137] The pressure member 44 normally has a curved shape in at
least part of the central portion 44b while the end portions 44a
are straight. In other words, the pressure member 44 has a normally
curved state 45a, i.e., first state. This state occurs prior to the
stress guard 40 being applied to the skin of the user.
[0138] The curved shape in at least part of the central portion 44b
may be achieved by casting, extruding, and/or forming central
portion to be curved. Therein, the central portion 44b may have any
suitable curve while the end portions 44a are straight.
[0139] The curved shape may also be made by pre-tensioning the
pressure member in a pre-stressed area (not shown), such as being
heat-treating. Therein, the pre-stressed area is preferably
disposed in the central portion 14b. In the pre-stressed area, the
pressure member has been stressed increasing a compression side,
moving the neutral axis in the pre-stressed area, and causing a
tension side to be reduced.
[0140] In the curved state 45a, the pressure member 44 is curved in
the pre-stressed area, while the end portions 44a are straight.
Therein, the end portions 44a are preferably, but not necessarily,
equidistant from the central portion 44b in lateral and offset
directions and are curved in the same direction. When the pressure
member 44 is in the curved state 45a, the stress guard 40 generally
follows the same curved contour as the pressure member 44 and also
is in the curved state 45a.
[0141] In accordance with one or more embodiments of the present
invention, one or more hinges 43 define the boundary between the
central portion 44b and respective end portions 44a. Therein, the
hinge 43 may be a plastic hinge or hinge having a groove or a
channel 43a. The groove or channel 43a may be formed to be a V
opening wherein each leg of the V has equal length, or has an
unequal length.
[0142] Preferably, the adhesive 46a may be one or more suitable
pressure-sensitive adhesives as is known in the art for adhesive
bandages. Due to their excellent adhesion strength, usability,
costs, and/or length of use, the adhesive 46a is preferably
selected from the group of acrylic, silicone, butyl rubber,
nitrile, styrene block copolymers (SBC), ethylene-vinyl acetate
(EVA), or a combination thereof. In addition or in the alternative,
the adhesive 46a may be a polyacrylate-based,
polyisobutylene-based, and/or silicone-based pressure-sensitive
adhesive; or a synthetic rubber, acrylic, hydrocolloid, or a like
compound adhesive. In addition or in the alternative, adhesive 46a
may also be a light-curable or heat-curable adhesive.
[0143] Preferably, regardless of type, adhesive 46a comprises a
T-peel release force of in the range of 0.45 N/cm to at least 19
N/cm. Therein, the T-peel release force and blunt probe tack force
of pressure-sensitive adhesives is in accordance with ASTM D1876
and ASTM D2979 or other appropriate methods.
[0144] The adhesive 46a is applied in the adhesive area 46b, which
is preferably a portion of or all of end portions 44a. The adhesive
46a is preferably not applied in the central portion 44b.
[0145] The stress guard 40 is applied to the patient 100, for
example, by straining it manually and then using the adhesive 46a
to secure it to skin of the patient. Therein, the pressure member
44 will be in a non-curved, substantially the non-curved state 45b,
i.e., second state. When the pressure member 44 is in substantially
non-curved state 45b, the stress guard 40 follows the same contour
as the pressure member 44 and also is in substantially the
non-curved state 45b. Substantially non-curved state 45b may be a
flat state or contour, and/or may be one where the pressure member,
i.e., stress guard, follows the contour of the skin.
[0146] In either curved state 45a or substantially the non-curved
state 45b, the pressure member 44 has the forces F3 and F4, which
combine as pressure 192 and are directed toward each other to pull
the wound 110 closed. That is, when the pressure member 44 is
curved, the forces F3 and F4 pull toward each other closing the
wound 110 or keeping the marginal edges of the wound closed.
[0147] Preferably, a stress guard 40 is selected so that it is
sufficiently sized, for example, by laying in a substantially
non-curved state 45b when applied to a wound, as shown in FIG. 12b,
and the wound's edges are being pulled toward each other to close
the wound area 112, if open, and/or relieve stress in the wound
area 112. As the wound heals, the wound area 112 becomes nil and
the stress guard changes to a substantially curved state 45a.
[0148] Advantageously, the pressure material may be pre-stressed to
a predetermined amount, and thus, the amount of curvature may be
selectively predetermined to the pressure member 44. In turn, by
varying the curvature, the central portion 44b can be predetermined
to exert specific forces F3 and F4 on the wound 110. In addition or
in the alternative, the shape and/or the thickness 44c of the
pressure member may be selected, as taught further herein, to
provide further predetermined refinement of forces F3 and F4.
Forces F3 and F4 are transferred as pressures to the patient via
the treatment device, since pressure is force per unit area.
[0149] Therein, increasing forces F3 and F4 will yield an increase
in pressure applied to at least the treatment area 114 via the
treatment device.
[0150] The pressure member 44 may have a thickness of 100 microns
to at least 2 mm, but preferably with a range of about 220 microns
to about 500 microns, or more preferably 300 microns to 400
microns. The pressure member 44 preferably has a length of
approximately 10 mm to 190 mm, i.e., 1 cm to 19 cm, and/or a width
of 8 mm to 100 mm, i.e., 0.8 cm to 10 cm.
[0151] In accordance with one or more embodiments of the present
invention, a kit for treating the wound 110 of the patient 100
comprises two different types pre-stressed pressure devices, i.e.,
the pressure bandage 10 and the stress guard 40, used at different
times during the treatment for effective wound healing and to
reduce the possibility of scarring. The pressure bandage 10 is
indicated for use during the acute and late wound phases. These
phases are immediately after the occurrence of the wound and up to
2 weeks after the occurrence of the wound. To treat the wound
during the intermediate phase, between 2 and 12 weeks, the stress
guard 40 is indicated. Therein, the system offers an ultimate
solution to the skin wound treatment and scar tissue relief.
[0152] FIG. 13 is a diagram illustrating a treatment system for
making a pre-stressed pressure device for treating a wound and/or
reducing scarring in accordance with one or more embodiments of the
present invention. Therein, the treatment system 500 for treating a
wound and/or reducing scarring comprises an imaging device 502, a
computing device 504 executing a computer-readable software 506
stored on a non-transitory computer readable media 508, a 3D
printer 510, a supply 512 of pressure material, a heating device
514, a supply 516 of substrate members 18a and 18b, and a supply
518 of treatment device 22.
[0153] Therein, when a patient 100 presents with a wound 110 or
with scarring, a user of the system, who preferably, but not
necessarily a qualified medical professional, uses imaging device
502, such as a digital camera, smartphone camera, ultraviolet
imaging apparatus, to take an image of the wound or scarring and/or
the contours of the area surrounding the wound or scarring. Using a
network or a storage device, the image is then transferred to a
computing device 504 such as a computer, mainframe device, tablet
computer, smartphone, or other device. The network herein may be
any kind of network including a cellular, wireless, Wi-Fi, LAN,
Ethernet, internet, private, public, or a combination thereof.
[0154] In accordance with one or more embodiments of the present
invention, the image is utilized by the user to define treatment
area 114. Software 506 stored on a non-transitory computer readable
media 508, such as CD-ROM or DVD, uses the defined treatment and/or
contours of the surrounding area to design the pressure member 14,
including the shape of the end portions 14a, the central portion
14b, the thickness 14c for any portion and any variations therein
as taught above, and transmits that information, preferably over a
network, to the 3D printer 510. The software then also calculates
the amount of pre-tensioning required and transmits that
information, preferably over a network, to heating device 514.
[0155] Therein, the 3D printer 510 may be any suitable additive
manufacturing printer. The printer 510, using supply 512 of the
pressure material, manufactures the pressure member 14 according to
the information sent by computing device. The same user or another
user then places the pressure member in the heating device 514.
[0156] The heating device 514 may be any kind of suitable device
that imparts energy into the pressure member 14. Thus, heating
device 514 may be a microwave, a radiant heater, a sonic welding
device, or a combination thereof. Using the information sent by the
computing device, the heating device 514 heats the pressure device
14 in the pre-stressed area 14d to impart the pre-tensioning. In
order to prevent unintended heating, a protective layer may be
printed on areas of the pressure device other than the pre-stressed
area 14d.
[0157] In addition or in the alternative, the pressure member 14
may also be made to be curved in the printer 512 and heating with
the heating device 514 may not be necessary.
[0158] After the pre-tensioning has been imparted in the pressure
member 14, it is joined to one or more substrate members 18a and
18b that are provided via a supply 516 and a treatment device 22
from the supply 518. If necessary, the substrate members 18a and
18b and the treatment device 22 may be sized according to sizing
information provided by the computing device 504 to produce a
pre-stressed pressure device configured, for example, as the
bandage 10 that may be applied to the patient. Similarly, the
stress guard 40 may be produced by the treatment system 500 by
itself and/or in conjunction with the pressure bandage 10.
[0159] While the invention has been described in conjunction with
specific embodiments, it is to be understood that many
alternatives, modifications, and variations will be apparent to
those skilled in the art in light of the foregoing description.
* * * * *