NZ704069B2 - Thermally-conductive, metal-based bandages to aid in medical healing and methods of use - Google Patents

Thermally-conductive, metal-based bandages to aid in medical healing and methods of use Download PDF

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Publication number
NZ704069B2
NZ704069B2 NZ704069A NZ70406912A NZ704069B2 NZ 704069 B2 NZ704069 B2 NZ 704069B2 NZ 704069 A NZ704069 A NZ 704069A NZ 70406912 A NZ70406912 A NZ 70406912A NZ 704069 B2 NZ704069 B2 NZ 704069B2
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NZ
New Zealand
Prior art keywords
bandage
layer
burn
aluminum
thermochromic
Prior art date
Application number
NZ704069A
Other versions
NZ704069A (en
Inventor
Carl Freer
Ericka Freer
Terrence Wyles
Original Assignee
Aluminaid International Ag
Carl Freer
Ericka Freer
Terrence Wyles
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2011/067256 external-priority patent/WO2013019266A1/en
Application filed by Aluminaid International Ag, Carl Freer, Ericka Freer, Terrence Wyles filed Critical Aluminaid International Ag
Priority claimed from PCT/US2012/046310 external-priority patent/WO2013019372A2/en
Publication of NZ704069A publication Critical patent/NZ704069A/en
Publication of NZ704069B2 publication Critical patent/NZ704069B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/56Wetness-indicators or colourants

Abstract

The inventive disclosure contained herein is generally directed to a class of medical bandages that in many embodiments are effective in the treatment of various types of tissue burns, whether be burns due to thermal burns, sun exposure, or rashes. Such products can include a plurality of specialized bandages and wraps that incorporate an extremely thin layer of thermally conductive metal (often aluminum) at the base of a substrate adapted to be in direct contact with a burn wound, while manufacturing the top side of the aluminum substrate to have a heat-dissipation-enhancing topography to help cool burns faster by enhancing thermal-convection properties. The bandage can also feature a thermochromic indicator for users to realize the thermal-cooling status of a burn to which a bandage has been applied. d bandages and wraps that incorporate an extremely thin layer of thermally conductive metal (often aluminum) at the base of a substrate adapted to be in direct contact with a burn wound, while manufacturing the top side of the aluminum substrate to have a heat-dissipation-enhancing topography to help cool burns faster by enhancing thermal-convection properties. The bandage can also feature a thermochromic indicator for users to realize the thermal-cooling status of a burn to which a bandage has been applied.

Description

THERMALLY CONDUCTIVE, METAL-BASED BANDAGES TO AID IN MEDICAL G AND METHODS OF USE CROSS-REFERENCE TO D APPLICATIONS The present patent application is a Continuation—In—Part of, and claims the benefit of Patent Cooperation Treaty (PCT) Application No. , filed on December 23, 2011, for num—Based Bandages to Aid in Medical Healing and Methods of Use”.
The present patent application also claims the t of US Patent ation No. 61/513,366, filed on July 29, 2011, for “Aluminum—Infused Compositions and Devices to Aid in Medical Healing and Methods of Use”.
The present patent application also claims the benefit of US. Patent Application No. 61/670,090, filed on July 10, 2012, for “Thermally Conductive, Metal—Based Bandages to Aid in Medical Healing and Methods of Use”.
In addition, the present patent application hereby incorporates by reference PCT Application No. 2011/67256, US. Patent Application No. 61/513,366, and US.
Patent ation No. 61/670,090, each in their entirety for all purposes.
BACKGROUND Burn injuries are caused by fire, chemicals, electricity, and friction and can vary in severity. First degree burns are the least severe, causing redness, and healing relatively quickly. On the other end of the spectrum, fourth degree burns are the most severe, burning down to the level of the muscle and bone. Second and third degree burns fall between these extremes.
Medical professionals often try to strike a balance when deciding how to treat burns.
On one hand, if a burn is superficial and relatively dry, then many feel that the wound should be kept moist with water or some sort of ointment or cream. For example, Dr Xu of China al has ped an “alternative” technique called Moist Exposed Burn Therapy, which, unlike the conventional way to heal a burn victim by keeping the burn wound dry, Professor Xu keeps the patient’s burn wound moist. Dr. Xu’ s treatment n requires very little administration of antibiotics and ectants to the burn wound. Instead, Dr. Xu uses natural herbs to aid burn— wound healing, wherein natural—plant extracts at the base of a beeswax is the main ingredient used. However, a problem with applying many ointments and/or creams is that such applications often do not help draw heat away from a wound. On the other hand, if a burn is more serious, such as a second—degree burn that is oozing fluid, then there is an enhanced fear of infection. In such cases, some medical professionals feel that such wounds should be kept relatively dry, while still others may advocate for the application of various nt dressings with antibiotic properties to fight infection. Hence, it would be desirable to come up with a treatment strategy that is able to provide the best of all worlds.
On August 30, 1948, Time Magazine ed that steam from an exploding locomotive had scalded Fireman Frank Mihlan of the Erie Railroad. When Mihlan was carried into Cleveland’s Charity Hospital on July 15, 1948, 70% of his body was burned, and doctors thought that Mihlan had little chance of al. However, attending surgeons decided to try wrapping the Mihlan’s burns in thin strips of aluminum foil, a que developed by Toronto’s Dr. Alfred W. Farmer. It was the first time that aluminum foil for burns had been used in the US; the first time it had ever been used for burns of the whole body. Relief from pain was “miraculous”, and within 20 minutes of application, Mihlan was resting comfortably. As an added precaution, Mihlan was given intravenous fluids and llin. The aluminum foil, which looked like the inside wrapping of a cigarette e, apparently acted as a seal for the body fluids that seep from burned es. It also apparently helped kill bacteria, speeding the healing process. Twelve days after being bandaged in the aluminum foil wrappings, Mihlan was out of bed. Eventually, Mihlan left the hospital unscarred, albeit arily reddened.
Further, a 2004 American Journal article reported: Aluminum foil as a dry sterile initial covering for thermal burns under occlusive pressure dressings has been presented as a method of diminishing the tion of a burn surface. The method appeared to influence favorably the local result by elimination of the use of nts and by facilitating the dispersion of exudate to the ery of the burn. No evidence of toxicity as a result of the treatment was found. The systemic reaction was, if ng, less obvious.
Despite the above-mentioned anecdotal report and the reported research, public data is not readily accessible in—relation to the practicable applications of using aluminum foil as a healing agent. In on, to date, there appears to be no commercially designed aluminum— derived medical products for general—purpose sale other than large blankets usually reserved for Emergency—Services organizations.
One existing known use for aluminum—derived products is in the employment of the astringent aluminum—based compound, aluminum chloride, which has been used in various concentrations in the art to apply to ant pads in order to cause constriction of sweat pores. For example, US. Patent No. 5,403,588 to Santa Ana is directed to a disposable body ant pad and deodorant ation therefor. The Santa Ana Patent basically dissolves 3 to 4 grams of aluminum chloride into about 130 cc of an e—isopropyl alcohol solution to achieve an effective constriction of the user’s sweat pores. Despite this known use, there are no aluminum—based compositions of matter available on the market for acting as a styptic or otherwise sealing a wound.
Ostensibly, there simply is no specific product range available to the general public that employs both the natural and by-product medical advantages of aluminum. For example, there are no bandages on the market that are comprised of extremely thin um layers or strips, and nor are there therapeutic creams, ointments, or other nal compositions that are infused with molecular compositions that ntially include aluminum.
It would be advantageous to develop a set of aluminum—infused healing/therapeutic products (e. g., specialized bandages, burn creams, etc.) that are easy for a consumer to safely 1.186.
BRIEF SUMMARY The inventive disclosure contained herein is generally directed to a class of l products that in many embodiments are effective in the treatment of tissue burns, whether be burns due to thermal burns, sun exposure, or rashes. Such products can include a ity of lized bandages and wraps that incorporate an extremely thin layer of a thermally conductive metal with enhanced material and surface features to ensure flexibility and effective heat—transfer characteristics to cool a burn wound. One key embodiment employing an enhanced heat—dissipation capability features a this aluminum substrate, with one side adapted to make direct contact with a burn wound, while the other side of the um ate exposes to the air a topography that resembles a microscopic field of cones, hollowed and also ing aeration to the wound. The hollowed cone structures provide a greatly sed exposed surface area of the aluminum substrate to encourage efficient thermal convection processes, while still allowing the bandage to flex in any needed direction. Besides exhibiting multiple properties that are beneficial to healing certain types of tissue wounds, as discussed infra, aluminum is non—toxic, easy to sterilize, relatively inexpensive and easy to fabricate with, and abundantly mined worldwide. after, the overall class of products described in this patent application is ed to as “AluminaidTM“ or “AluminaidsTM“. These aluminum—derived products are specifically designed to alleviate the discomfort and pain caused by thermal burns.
Additionally, AluminaidsTM, h a combination of natural composition and the prevailing production processes, inherit the potential to minimize scarring, inhibit infection, prevent maceration, and reduce the necessity for later skin grafting.
The inventive principles and disclosures provided in this patent application can be d to any thermally tive metal-based substrate, and as such are contemplated as being included within the scope of this patent application, including the appended claims.
The forgoing Brief Summary is provided as a convenient overview of a few key (but not all) embodiments; however, it is not intended to limit the scope of the disclosures contained within this patent application, including the appended claims and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS This patent application is a Continuation-In-Part of, and incorporates by reference, Patent Cooperation Treaty (PCT) ation No. PCT/US20l 1/67256, filed on December 23, 2011, for “Aluminum-Based Bandages to Aid in Medical Healing and Methods of Use”.
However, for convenience and clarity for the reader, original Figures 1A-19 from PCT Application No. are repeated in the present patent application.
However, Figures 20A-31G, which depict some additional and/or refined embodiments, have been added to the sure. Brief ptions for all of the figures are as follows: Figure 1A depicts one embodiment of an AluminaidTM bandage (large—rectangular general form factor), showing the top—side topography that features a field of heat— dissipation—enhancing cone—like protrusions.
Figure 1B depicts one embodiment of an AluminaidTM bandage (large-rectangular l form factor), g the bottom—side topography that features a substantially smooth um substrate, which is intended to make contact with a user’s tissue.
Figure 2A depicts one ment of an AluminaidTM e (large—rectangular general form factor), showing the top—side topography that features a field of heat— dis sipation—enhancing pyramid—like protrusions.
Figure 2B s one ment of an AluminaidTM bandage (large—rectangular general form ), showing the bottom—side topography that es a substantially smooth um substrate, which is intended to make t with a user’s .
Figure 3A depicts one embodiment of an AluminaidTM bandage (narrow, substantially rectangular general form factor), showing the top-side topography that features a field of issipation—enhancing cone—like sions.
Figure 3B depicts one embodiment of an AluminaidTM bandage (narrow, ntially rectangular general form factor), showing the bottom—side aphy that features a substantially smooth aluminum substrate, which is intended to make contact with a user’s tissue.
Figure 4A depicts one embodiment of an AluminaidTM bandage (narrow, substantially rectangular general form factor), g the top—side topography that features a field of heat—dissipation—enhancing pyramid—like protrusions.
Figure 4B depicts one embodiment of an AluminaidTM bandage (narrow, substantially rectangular general form factor), showing the bottom—side topography that features a substantially smooth aluminum substrate, which is intended to make contact with a user’s Figure 5A depicts one embodiment of an aidTM bandage (finger-form-factor), g the top—side topography that features a field of heat—dissipation—enhancing cone—like protrusions. This form factor includes an end adhesive tab 35 adapted to engage the end of a finger, and three incrementally sized sections 20, 25, 30 for engaging an ated region of a finger the bandage is applied to.
Figure 5B s one embodiment of an AluminaidTM bandage (narrow finger—form— factor), showing the bottom—side topography that features a substantially smooth aluminum substrate, which is intended to make contact with a user’s tissue. This form factor includes an end adhesive tab 35 adapted to engage the end of a finger, and three incrementally sized sections 20, 25, 30 for engaging an associated region of a finger the bandage is applied to.
Figure 6A depicts one embodiment of an AluminaidTM bandage (finger—form—factor), showing the top—side topography that features a field of heat—dissipation—enhancing pyramid— like sions. This form factor includes an end adhesive tab 35 adapted to engage the end of a finger, and three incrementally sized sections 20, 25, 30 for engaging an associated region of a finger the bandage is applied to.
Figure 6B depicts one embodiment of an AluminaidTM bandage (narrow finger—form— factor), showing the bottom—side topography that features a substantially smooth um substrate, which is intended to make contact with a user’s tissue. This form factor includes an end adhesive tab 35 adapted to engage the end of a finger, and three incrementally sized sections 20, 25, 30 for engaging an ated region of a finger the e is applied to.
Figure 7 depicts one embodiment of a roll of AluminaidTM bandage material, wherein the majority of the surface area is dedicated to an aluminum substrate with a smooth side (the side to be applied to tissue) and with a side having a field of heat—dissipation—enhancing protrusions or ridges. In some embodiments, the top and bottom edges of the roll include a line of polymer al with an adhesive to facilitate ment to a part of a user body. In other variations, these polymer-adhesive strips are not included and the dispensed amount of bandage roll is secured to a user’s body with strips of medical tape and/or gauze.
Figure 8 depicts one ment of a side view of an AluminaidTM bandage, showing the relationship between the um substrate and the surrounding second layer/adhesive.
Figure 9A depicts one embodiment of a possible topography for the air—exposed side of an AluminaidTM bandage’s aluminum substrate, featuring in this case, as an example, a plurality of rows of cone—shaped or mound—shaped sions, every other row staggered relative to its neighbor rows to maximize the outer surface area available to facilitate heat transfer away from a user’s ound. In this particular example, each protrusion is shown separated by a distance along the aluminum substrate from each other, and that ce can be varied n embodiments, and can even be a zero distance in some variations).
Figure 9B depicts one embodiment of a le topography for the air—exposed side of an AluminaidTM bandage’s aluminum substrate, featuring in this case, as an example, a plurality of rows of pyramid—shaped protrusions to maximize the outer surface area available to facilitate heat transfer away from a user’s body/wound. In this particular example, each protrusion is shown immediately adjacent to each other; however, in other embodiments, the protrusions can be ted by a distance along the aluminum substrate.
Figures 10A-10N each depicts one embodiment of a le heat—dissipation— enhancing protrusions, including s exemplary ments of pyramid-type protrusions, cone—like protrusions, half—dome—like protrusions, and protrusions hollows manufactured in the top—center that can extend down the length of the raised protrusion and even all the way through the aluminum substrate of an AluminaidTM bandage.
Figure 11A depicts one embodiment of an AluminaidTM bandage al form factor), wherein the external surface topography of the aluminum ate (that is, the surface not designed to be in direct contact with a user’ s skin) is increased with a plurality ridges in order to increase heat dissipation.
Figure 11B depicts one embodiment of a magnified section of the aluminum substrate of the embodiment of an AluminaidTM bandage depicted in Figure 11A.
Figure 12A s one embodiment of a partial—side view of an AluminaidTM bandage (general form factor), wherein the outer surface area of the aluminum substrate (that is, the surface not ed to be in direct contact with a user’s skin) is increased with a plurality of surface protrusions; e. g., ridges, cones, or pyramids; in order to increase heat ation.
Figure 12B depicts one embodiment of a close—up, partial side view of an AluminaidTM bandage depicted in Figure 12A, wherein the outer surface area of the aluminum substrate (that is, the surface not ed to be in direct contact with a user’s skin) is increased with a ity of surface protrusions; e.g., ridges, cones, or pyramids; in order to increase heat dissipation, and wherein some candidate dimensions are introduced. It should be noted that the ions provided are exemplary only and are not intended to limit the scope of the inventive disclosure.
Figure 13A depicts one embodiment of an AluminaidTM e (general form ), and also includes thermochromic visual indicators, which display themselves when the aluminum substrate to which they are coupled experiences certain temperatures.
Figure 13B depicts one ment of a cutaway—view of an AluminaidTM bandage (general form factor), which also shows the relationship n the thermochromic Visual indicator(s) and the aluminum substrate.
Figure 14 s one embodiment of an AluminaidTM bandage (general form factor), and also includes a thermochromic visual indicator, suspended above the aluminum substrate Via a “bridge” comprised of aluminum strips, which tes when the aluminum ate ences certain predetermined temperatures.
Figure 15 depicts one embodiment of an AluminaidTM bandage (general form factor), and also includes a thermochromic visual indicator, wherein thermochromic compound is disposed on the tops of a subset of the aluminum substrate protrusions, the subset of thermochromic coated protrusions indicating when the aluminum substrate experiences certain predetermined temperatures.
Figure 16 depicts one embodiment of an AluminaidTM bandage (large-rectangular l form factor), showing the top—side topography that features a field of heat— dissipation-enhancing cone-like protrusions, a thermochromic visual indicator in thermal communication with the aluminum substrate, and a plurality of rows of manufactured aeration holes to supplement the randomly occurring pinholes that are part of the normal aluminum—rolling process due to impurities. Though this particular embodiment shows only rows of aeration holes, in other variations, columns of aeration holes can be present on the aluminum substrate as well. The size and population densities of the aeration holes can be varied with particular applications.
Figure 17 depicts one embodiment of an AluminaidTM e —rectangular general form ), showing the de aphy that features a field of heat— dissipation—enhancing pyramid—like protrusions, a thermochromic visual indicator in thermal communication with the aluminum substrate, and a plurality of rows of manufactured aeration holes to supplement the randomly occurring pinholes that are part of the normal aluminum—rolling s due to impurities. Though this particular embodiment shows only rows of aeration holes, in other variations, columns of aeration holes can be present on the aluminum substrate as well. The size and population densities of the aeration holes can be varied with particular applications.
Figure 18 depicts one embodiment of an AluminaidTM bandage (narrow, substantially rectangular general form factor), showing the top—side topography that features a field of heat—dissipation—enhancing cone—like protrusions, a chromic visual indicator in thermal communication with the aluminum substrate, and a plurality of rows of manufactured aeration holes to supplement the randomly occurring pinholes that are part of the normal aluminum—rolling process due to impurities. Though this ular embodiment shows only rows of aeration holes, in other variations, columns of aeration holes can be present on the aluminum substrate as well. The size and tion ies of the aeration holes can be varied with particular ations.
Figure 19 depicts one embodiment of an AluminaidTM bandage (narrow, substantially rectangular general form factor), showing the top—side topography that features a field of heat—dissipation—enhancing pyramid—like protrusions, a thermochromic visual indicator in thermal communication with the aluminum substrate, and a plurality of rows of manufactured on holes to supplement the randomly occurring pinholes that are part of the normal aluminum—rolling process due to impurities. Though this particular ment shows only rows of aeration holes, in other variations, columns of aeration holes can be present on the um substrate as well. The size and population densities of the aeration holes can be varied with particular applications.
Figure 20A depicts one embodiment of a small n of a thermally conductive, metal-based substrate that can be used in AluminaidTM bandage, g a variation of the top—side topography that features a field of heat—dissipation—enhancing cone—like protrusions with holes disposed at the top of each protrusion.
Figure 20B depicts one embodiment of a small portion of a thermally conductive, metal—based substrate that can be used in AluminaidTM bandage, showing a variation of the bottom—side topography that features a substantially smooth aluminum substrate interspersed with holes that extend into and through their tive heat—dis on—enhancing cone-like protrusions. This bottom surface is adapted to make contact with a user’s tissue.
Figure 21A depicts one embodiment of a small portion of a thermally conductive, metal—based substrate that can be used in AluminaidTM bandage, showing a variation of the top—side topography that features a field of heat—dissipation—enhancing cone—like protrusions with holes disposed at the top of each protrusion.
Figure 21B s one embodiment of a small portion of a thermally conductive, metal—based substrate that can be used in AluminaidTM bandage, showing a variation of the bottom-side topography that features a ntially smooth aluminum substrate interspersed with holes that extend into and through their respective heat—dis sipation—enhancing cone—like protrusions. This bottom surface is adapted to make contact with a user’s .
Figure 22A depicts one embodiment of a small portion of a thermally conductive, based substrate that can be used in AluminaidTM bandage, showing a variation of the top—side topography that features a field of heat—dissipation—enhancing cone—like protrusions with holes disposed at the top of each protrusion.
Figure 22B depicts one embodiment of a small n of a thermally conductive, metal—based substrate that can be used in AluminaidTM bandage, g a variation of the bottom-side topography that es a ntially smooth aluminum substrate interspersed with holes that extend into and through their tive heat—dis sipation—enhancing cone—like protrusions. This bottom surface is adapted to make contact with a user’s tissue.
Figure 23A depicts one embodiment of a small portion of a thermally conductive, metal—based substrate that can be used in AluminaidTM bandage, showing a variation of the top—side topography that features a field of heat—dissipation—enhancing cone—like protrusions with holes disposed at the top of each protrusion.
Figure 23B depicts one embodiment of a small portion of a lly conductive, metal—based substrate that can be used in aidTM bandage, showing a variation of the bottom-side topography that features a substantially smooth aluminum substrate interspersed with holes that extend into and h their respective heat—dis sipation—enhancing cone—like protrusions. This bottom surface is d to make contact with a user’s tissue.
Figures 24A and 24B depict one ment of a top and side—cutaway View, respectively, of a small portion of a thermally tive, metal—based substrate that can be used in AluminaidTM bandage, showing a variation of the top—side topography that features a field of heat—dissipation—enhancing ike protrusions with holes ed at the top of each protrusion. In this embodiment, it can be seen that the holes in the heat—dissipation— ing protrusions are narrower at the top of each respective protrusion, while widening as the bottom surface of the substrate is reached. The holes extend completely through the substrate, which helps aerate wounds as well as increase the amount of exposed surface area ble to enhance thermal—convection processes.
Figure 25 depicts one form factor of one embodiment of an ed view of an AluminaidTM bandage, including an outer polymeric layer, an intermediate absorbent layer, a transfer adhesive layer, a thermally conductive, metal—based substrate layer, and a removable backing layer for protecting the adhesive material disposed about the outer perimeter of the e until ready for application to a wound.
Figure 26 depicts one form factor of one embodiment of an exploded view of an aidTM bandage, including an outer polymeric layer, an intermediate absorbent layer, a thermally conductive, metal—based substrate layer, and a removable backing layer for ting the adhesive material disposed about the outer perimeter of the bandage until ready for application to a wound.
Figure 27 depicts one form factor of one embodiment of an exploded view of an AluminaidTM bandage, including an outer polymeric layer, an intermediate absorbent layer, a thermally conductive, metal—based substrate layer, and a removable backing layer for protecting the ve material disposed about the outer perimeter of the bandage until ready for application to a wound.
Figure 28 depicts one embodiment of an exploded view of a finger—form—factor AluminaidTM bandage, including an outer ric layer, an intermediate absorbent layer, a thermally conductive, metal—based ate layer, and a removable backing layer for protecting the adhesive material disposed about the outer perimeter of the bandage until ready for ation to a wound.
Figure 29 depicts one form factor of one embodiment of an exploded View of an AluminaidTM bandage, including an outer polymeric layer, an intermediate absorbent layer, a thermally conductive, metal-based substrate layer, and a removable backing layer for protecting the adhesive material disposed about the outer perimeter of the bandage until ready for application to a wound.
Figure 30 depicts one embodiment of a portion of a uous strip of multiple copies of the AluminaidTM e embodiment depicted in Figure 29, coupled together, whereby users can tear—off the length of bandage ed and wrap the user—sized bandage strip around/over the wound area.
Figures 31A-31G depict various ments of the top—view of different AluminaidTM bandage sizes and shapes. However, no attempt is made to depict any aluminum—substrate topography details in these figures.
DETAILED DESCRIPTION 1. Introduction The inventive disclosure contained herein is lly directed to a class of medical products that in many embodiments are effective in the treatment of tissue burns, whether be burns due to thermal burns, sun exposure, or . Included in such products are various lized bandages and wraps that incorporate an extremely thin layer of thermally conductive metal with uniquely enhanced material and surface es to ensure flexibility and effective heat—transfer characteristics to cool a burn wound.
Aluminum is generally favored as the basis of the bandages because besides exhibiting multiple properties that are beneficial to healing certain types of tissue wounds, as discussed infra, um is non—toxic, easy to sterilize, relatively inexpensive and easy to fabricate with, and abundantly mined worldwide. Hereinafter, the overall class of ts described in this patent ation is referred to as “AluminaidTM“ or “AluminaidsTM“.
II. Terminology The terms and phrases as indicated in quotes (“ 77) in this section are intended to have the meaning ascribed to them in this Terminology section applied to them throughout this patent application, unless clearly indicated otherwise in context. Further, as applicable, the stated tions are to apply, regardless of the word or phrase’s case, to the singular and plural variations of the defined word or phrase.
The term “or”, as used in this patent application, is not meant to be exclusive; rather, the term is inclusive, meaning “either or bot ”.
References in this patent application to “one embodiment77 6‘ 77 ‘6 an embodiment a , , preferred embodiment”, “an alternative embodiment”, “a variation”, “one variation”, and similar phrases mean that a particular feature, structure, or characteristic described in connection with the ment is included in at least an embodiment of the invention. The ances of the phrase “in one embodiment” and/or “in one variation” in various places in this patent application are not necessarily all meant to refer to the same embodiment.
The term e” or “coupled”, as used in this specification and the appended claims, refers to either an indirect or a direct connection between the identified elements, components, or objects. Often, the manner of the coupling will be related specifically to the manner in which the two coupled elements interact.
The terms “removable77 6‘removably coupled”, “readily removable77 6‘ , , readily detachable”, “detachably coupled”, and r terms, as used in this patent application specification (including the claims and drawings), refer to structures that can be uncoupled from an adjoining structure with relative ease (i.e., structively, and without a complicated or time—consuming process) and that can also be readily reattached or d to the previously adjoining ure.
The term d”, “bonding”, and similar terms, as used in this patent ation specification (including the claims and gs), refer to any means that is used to fixedly couple two or more structures together, such as the layers in the uction of some embodiments of AluminaidTM bandages. Examples of bonding include the use of adhesives between es, ultrasonic welding, thermoplastic welding, etc.
Directional and/or relational terms such as, but not limited to, left, right, nadir, apex, top, bottom, vertical, horizontal, back, front, and lateral are relative to each other, are dependent on the specific orientation of an applicable element or article, are used accordingly to aid in the description of the various embodiments in this specification and the appended claims, and are not necessarily intended to be construed as limiting.
As applicable, the terms “about” or “generally”, as used herein in the specification and ed claims, and unless otherwise indicated, means a margin of +- 20%. Also, as applicable, the term antially” as used herein in the specification and appended claims, unless otherwise indicated, means a margin of +- 10%. It is to be appreciated that not all uses of the above terms are quantifiable such that the nced ranges can be applied.
The term “aluminum,3 LLaluminum compound”, um alloy”, and similar terms, as used in this patent application (including the drawings and claims), refer to any al is substantially comprised of the element Aluminum (Period Element Symbol “Al”, atomic number 13). Generally, any machined or otherwise processed aluminum composition or ure (e. g., very thin aluminum sheets or strips) that can be ively incorporated into a medicinal ointment or cream, or into sheeting to make l bandages, is included in this definition. Examples of aluminum-based molecular compounds that can be used with the teachings of this disclosure include aluminum oxides (e. g. A1203), aluminum sulfates (e. g., A12(SO4)3(H20)18), aluminum des (e.g., AlCl3), aluminum salts (e. g., aluminum diacetate (HOA1(C2H3OZ)2)), etc. Many such compounds can be used by the teachings of this sure to enhance the effectiveness of aluminum-based or aluminum—infused l and first—aid products. For example, um diacetate can enhance the antiseptic and astringent properties of a medical bandage, while also enhancing the thermal conductivity away from a burn wound.
III. AluminaidTM Bandages and/0r Wraps A. AluminaidTM Theory of Operation AluminaidTM products deploy natural occurrences of physics combined with specific application and form factor. Essentially, AluminaidsTM include the physical properties inherent in aluminum, such as “specific heat capacity” and al conductivity”.
Taking an AluminaidTM bandage as an example, specific heat capacity accounts for the amount of heat that the aluminum foil disposed in the e can store at any one time and thermal conductivity accounts for how fast that aluminum material can potentially conduct heat (somewhat analogous to how fast an electrical wire of a given material can t electricity).
There are three ways in which thermal energy transfer can be described: - Conduction; - Convection; and 0 ion.
Conduction requires physical t (similar to the flow of electricity in wire).
Convection emanates from the movement of molecules (e.g., the way in which heated and cooled water or other fluid moves up and down). Radiation does not necessarily involve direct contact (e. g., the way the sun emits light rays).
At any given temperature, a given mass of aluminum holds much less energy than an equivalent mass of human flesh. For instance, in convection or conduction, if one touches aluminum foil from an oven during the cooking process, a subject’s hand and the foil share the l energy. The hand (of much greater mass) requires much more energy to raise its temperature (if at all, depending upon the physical connection between the foil and the food).
When the subject touches aluminum foil, the foil ers heat to the flesh; however, due to the aluminum’s low specific—heat capacity, the foil y loses energy, barely raising the temperature of the skin in contact. Because aluminum foil does not effectively store ted heat, it therefore facilitates the “cooling” of a burn whilst simultaneously (in part) preventing other associated risks such as infection, ation, and hypothennic symptoms.
While aluminum does not effectively store conducted heat, aluminum is nonetheless an excellent conductor of heat. Aluminum will conduct any heat from the point of contact and will readily give the heat up to any heat sink, even to the ambient. This has a g effect to the source of the thermal heat and a heating effect to the heat sink.
In short, aluminum foil can be an ive conductor of a subject’s body heat, alleviating pain which emanates from added warmth on a subject’s burn wound.
Table 1 shows the comparatively low specific resistance of aluminum: TABLE 1: Comparison of Specific ance of Aluminum to Various Metals at 20 Degrees Celsius micro-ohm-cm Of , there are other metals with thermal—conductivity teristics that are equal to or better than that of aluminum. However, bandage dressings based on such alternative ; e. g., platinum or tungsten; are generally significantly more expensive to use and/or are not as easy to work with in the manufacturing s when compared to aluminum and various aluminum alloys. Nevertheless, though aluminum is a preferred material when taking into account its cost, thermal conductivity, and other physical properties that make manufacturing easier, it should be appreciated by those skilled in the art that the special heat—dissipation—enhancing configurations for bandage metal substrates disclosed herein can also be applied to substrates made of metals other than aluminum.
Further still, aluminum foil as a dry, sterile, initial covering for thermal burns under occlusive pressure dressings has been presented as a method of shing the maceration of a burn e. The method appears to influence favorably the local result by elimination of the use of ointments, and by facilitating the dispersion of exudate to the periphery of the burn.
No evidence of toxicity as a result of the treatment was found. The systemic reaction was, if anything, less obvious.
This elimination or at least minimization of applied ointments and other topical ents by employing aluminum-based bandages and/or wrapping can help avoid adverse consequences to a patient. For example, titanium dioxide re cream, as a burn ointment, was considered to be irritating from the evidence of production of pain, delayed healing, and possible destruction of epithelial remnants. Moreover, it has been observed that when massive doses of ascorbic acid was administered to burn patients, the doses quickly corrected the state of ascorbic acid depletion; r, the general systemic reaction to l burns was not found to be influenced by this form of treatment, and the general signs of illness were marked in severe cases.
B. General AluminaidTM Bandage Forms Refer to s 1A-31G (in ular, s 20A-31G depict some preferred designs), which depict examples of some exemplary embodiments of AluminaidTM es, which are discussed in the n disclosure herein. It should be noted that many of the exemplary embodiments have similar, but differently configured components, and as such said components are given common reference numbers. For example, all embodiments of the AluminaidTM bandages include an aluminum substrate, given the reference number of “5”, and the bandage in general is assigned the reference number of “10”. If an embodiment is so equipped, the nding outer second—layer substrate is assigned the reference number of “15”. In some embodiments, an intermediate surrounding absorbent layer is disposed between the perimeter of the aluminum substrate 5 and the outer second layer 15, and this intermediate layer is assigned the reference number of “12”. In still other variations, a transfer adhesive layer is disposed between the perimeter of the aluminum substrate 5 and the ter of the absorbent layer 12, and this transfer adhesive layer is assigned the reference number of “13”. Finally, in many embodiments, an easily ble bandage—backing layer is disposed across the entire bottom surface of a bandage 10, and this back layer is assigned the reference number of “14”. r, if a given discussion of a bandage component is particularly tied to a specific Figure, then the Figure number is provided along with the reference number.
In many embodiments, AluminaidTM bandages 10 are designed for use in the treatment of low—degrees of burn instances (usually first or second—degree burns). In specific embodiments directed to bandages and other types of applied medical wrappings, AluminaidTM bandages 10 are designed to fit most body shapes, sizes, and provision for children, ers, and adults (of both genders). In typical embodiments, the aluminum base of a bandage 10 is coupled about its perimeter with a material 15 to facilitate adhesive coupling to user skin, wherein the second material 15 extends beyond the boundaries of the aluminum ate 5. In some variations, the aluminum base 5 of a bandage 10 is coupled about its perimeter to the outer second material 15 via an intermediate ent layer 12, n the ent layer 12 can be any appropriate sterile and absorbent material, such as gauze, but is preferably made of hydrogel.
In other variations, the aluminum base 5 has a smooth side adapted to make direct contact with a burn wound, while the other side is manufactured to have a plurality of heat- dissipation—enhancing surface protrusions; such as cone, half—sphere, or pyramid — shaped nodes (see, e. g., Figures N and 20A-24B). In still another variation, the aluminum base 5 is substantially manufactured by a stamping process wherein a plurality of said heat-dissipation-enhancing surface protrusions are present on one side (and are substantially hollowed—out from the stamping process) while the other side, adapted to make contact with tissue, presents a plurality of holes as a result of the cturing process. In this variation, said voids/holes aid in aeration of wounds and this type of topography is ally effective for enhancing thermal tion processes for cooling wounds.
In many embodiments, each AluminaidTM product can be designed to fit a wide variety of different form factors directly relating to specific body parts, such as fingers and hands. For example, a wrap—around bandage adapted to create a form—fitting mitt with a thin um lining to thermally conduct heat away from the burned tissue of a hand can be used, wherein the outer surface of the mitt s the other side of the aluminum lining to the air for heat dissipation. In other variations, more—general form factors; such as circular, rectangular strips, ovals, etc. are used to produce general—purposes pads. (See, e. g., Figures 1A-7; 11A-11B; and 31A-31G.) Such embodiments are adapted to easily conform to the contours of specific parts of the body, but are sufficiently robust to avoid fractionation specifically during application, thus aiding healing and subsequent e removal.
In still other embodiments, aluminum foils 5 up to 0.5 mil thick are used, which are impermeable to oxygen and water, and which become slightly permeable due to minute es caused by the production process. In other ions, however, such bility can be desirable in cases where a medical professional desires to allow a burn wound to drain and dry out, while still providing the thermal—conduction benefits of the applied aluminum.
It should be noted that due to the manufacturing process, typical aluminum foil has a shiny side and a matte side (the reflectivity of the shiny side is typically 88%, while the dull, matte side lly has about 80% reflectivity). However, there does not appear to be any statistically significant difference in effectiveness between applications where the shiny side is applied to the wound or where the matte side is applied to the wound 60. The shiny side is produced when the aluminum is rolled during the final pass. It is difficult to produce rollers with a gap fine enough to cope with the foil gauge; therefore, for the final pass, two sheets are rolled at the same time, doubling the ess of the gauge at entry to the rollers. When the sheets are later separated, the inside surface is dull, and the outside surface is shiny. The resultant manufactured material is often gas and liquid permeable. In some other embodiments, the aluminum substrate 5 of the bandage is comprised of either permeable um foils or sheets/strips of aluminum foils with intentionally manufactured gaps.
In order to enhance the heat-dissipation capabilities and efficacy of AluminaidTM bandages 10, the mass of the aluminum substrate 5 is strategically configured via top—side topographies that both optimize the overall mass of the aluminum substrate enough to e thermal conductivity at the bio—interface of the bandage 10, as well as se the available exposed surface area in order to se thermal convection ses to the ambient air. The thermal—conduction processes are important during the immediate period of a few seconds to a minute after bandage application to a burn wound; however, thereafter, the thermal—convection processes are considered more significant to continued wound cooling.
Therefore, in the long run, it has been found that wound—cooling efficacy is ed by ensuring that the formation and topography of the aluminum substrate 5 is such that thermal— convection ses are optimized.
In still more embodiments, the aluminum substrate 5 is manufactured for one side to include a plurality of very small protrusions and/or ations, which increases the effective surface area for the dissipation of heat away from a burn wound. For e, referring to Figures 1A-7 and 20A-30, in a variation, the outer surface area of the aluminum substrate 5 (that is, the e not designed to be in direct t with a user’s skin) is sed with a dense plurality of te protrusions (see, e. g., Figures 10A-10N and 20A- 24B) that can have any of a variety of shapes and sizes, though based on testing some are more effective than others. In some variations, these discrete sions can be cone—shaped, mound—shaped, and/or pyramid-like shaped, though other shapes are possible as well. In some variations, referring to Figure 9A, ating rows of cones/mounds are staggered with respect to adjacent rows in order to be able to pack in more such heat—dissipation— enhancement protrusions on the aluminum substrate 5. Conversely, referring to Figure 9B, in other ments, the rows of heat—dissipation—enhancing protrusions are not staggered.
In another embodiment, the aluminum substrate 5 is substantially manufactured by a stamping process wherein a plurality of said heat-dissipation-enhancing surface protrusions are present on one side (and are substantially hollowed—out from the stamping s) while the other side, adapted to make contact with tissue, presents a ity of voids/holes as a result of the manufacturing process. In this variation, said voids/holes aid in aeration of wounds and this type of topography is especially effective for enhancing thermal convection ses for cooling wounds.
In variations, each of the plurality of discrete heat—dissipation—enhancing protrusions and/or ridges is separated along the base plane of the aluminum substrate 5 by a distance.
The separation distance used impacts the l flexibility of the aluminum substrate, as well as the heat—dissipation effectiveness because as the distance increases, fewer discrete heat— dissipation—enhancing protrusions and/or ridges can populate the aluminum substrate 5. In various embodiments, the separation distances generally range between 0 (zero) and 0.5 mm, but can be increased in other applications. It should be appreciated by those skilled in the art that as the separation distance decreases and as the angle incline of the adjacent discrete protrusions increases, then the concave flexibility of the aluminum substrate 5 is adversely impacted.
Referring to Figures 16-19, in a ion, a plurality of rows of aeration holes 95 are ed between rows of heat-dissipation-enhancement protrusions or . In another variation, a plurality of rows and columns of aeration holes 95 are ed between rows and columns of heat-dissipation-enhancement protrusions. In some embodiments, the manufactured aeration holes are 0.2 mm in diameter, with other variations using aeration holes with diameters that range in size from 0.1 to 0.3 mm. In variations, the spacing between the manufactured aeration holes, which inherently ates to the number of manufactured aeration holes provided over an entire aluminum substrate 5, strikes a e the efficacy of the healing s of the bandage 10 and concerns over the structural integrity of the aluminum substrate. If too many manufactured aeration holes of a given size are placed too close together in a row, then the aluminum substrate 5 could have some weak points subject to easy g. In general, such aeration holes are equi—spaced between the heat—dissipation-enhancement protrusions or ridges, with sufficient space between the aeration holes so that the aluminum substrate 5 can flex along a line of said aeration holes without tearing the substrate material between the holes. In the case of relatively small—sized bandages 10, a common spacing between the aeration holes is about 4 mm. For relatively —sized bandages, a common spacing between the aeration holes is about 6 mm. For relatively large bandage applications, a common spacing between the on holes is about 8 mm. It should be appreciated by those skilled in the art that the entioned on hole spacing are exemplary only, and the needed spacing distances can vary according to a variety of factors, including the exact aluminum alloy used, whether any strain hardening or annealing processes ed on the alloy, etc.
In yet another variation, referring to Figures 10J-10N and 20A-24B, the some or all of the ity of discrete protrusions on the aluminum substrate include a hole in the middle of the protrusion. In some versions of this, the protrusion’s central hole is a tapered hole and extends all the way h the aluminum substrate, thereby providing a strategically sized and placed on hole to aid in burn—wound healing, while also increasing the amount of surface area ble for thermal convection to the ambient air. In other versions, the protrusions are formed by way of a stamping process that also puts a hole at the top of each protrusion so as to effectively make each protrusion substantially hollowed-out; that is a reverse taper as compared to the previously described version. (See e. g., Figures 20A-24B.) In addition, the presence of a substantial hole into the body of the protrusions also provides an even greater increase in the amount of protrusion surface area available for thermal— convection processes. An example of the dimensions “S”, “D”, “H”, “T”, and “V” for such hollowed—out protrusions, as depicted in Figures 24A-24B, are provided in Table 2: TABLE 2: Exemplary Dimensions for Hollowed Heat-Dissipation-Enhancing Protrusions With Aeration Holes Disposed Through the sions 0.010" 0.015” 0.016” 0.005” n0015” 0.020” 0.030” 0.005” 0.025" 0.030" 0.0087, n0030” 0.020” 0.040” 0.005” It should be noted by those skilled in the art that the four es in Table 2 are exemplary only, and that such hollowed—out, aerating heat—dissipation—enhancing protrusions can be fabrics to other dimensional specifications.
Many of the variations described herein, especially in Table 2, supra, as well as in Figures 20A-31G, were subjected to significant analysis and testing, including finite element method (FEM) is to p optimum substrate topographies and geometries. Some of said testing is described in US. Patent Application No. 61/670,090, filed on July 10, 2012, for “Thermally Conductive, Metal—Based Bandages to Aid in Medical Healing and s of Use”, which is orated by reference.
In still more variations, referring to s 11A-12B, a dense plurality of ations or ridges 50, 55 are provided on the outer surface of the aluminum substrate 5 to enhance the heat—transfer/dissipation capabilities of the um substrate 5. However, because in some embodiments the aluminum substrate 5 material can be strain hardened, especially in the thicker (corrugated) regions of the aluminum substrate 5, bandages using such corrugations/ridges may not be optimally e along the axis parallel with the rows of ridges/corrugations. This renders a e less useful for application to various parts of the body as it may be more difficult for a user to conform a bandage’s aluminum substrate 5 to a particular part of a user body without overly stressing the aluminum substrate 5 along the longitudinal axis of the ridges, thus compromising the integrity and possible effectiveness of the bandage 10.
In some embodiments, a plurality of pyramid—shaped, cone—shaped, and/or dome— shaped protrusions manufactured in the aluminum substrate 5 is preferred over corrugations/ridges because, while the available outer surface area for heat—dissipation enhancement is largely equal between the two solutions (assuming equivalent widths and peak heights), an um substrate 5 with a plurality of non—ridge—like protrusions is more flexible along multiple axes. This is important because it furthers the goal of being able to readily apply bandages 10 to a wide variety of body applications and form factors.
It should be appreciated by one ordinarily skilled in the art that number, size/dimensions, and shape of the heat—sink protrusions and/or corrugations depicted in Figures 1A-31G are merely exemplary, and that many other shapes and sizes of cone-like or like structures (or similarly effective geometric structures) could be used for the aluminum substrate 5 in order to enhance the heat er of the bandage 10.
In yet more variations, a thermally conductive adhesive, paste, gel, or grease is d to the area of a user’s skin to enhance the heat transfer from a burn wound to the aluminum substrate heat sink 5. In some of these variations, the thermally conductive compound is derived from metal or silicone (usually with a zinc—oxide or aluminum—oxide inclusion to improve conductivity), and essentially fills gaps where air would normally be present. The thermally conductive compound provides a superior conductor (as compared to air) almost equal to that of the tor (the aluminum substrate 5) itself. The performance of thermally conductive compound is measured in W/m-K. Standard n/zinc-oxide thermal compound has thermal conductivities in the range of 0.7—0.9 W/m—K.
In such ions, the thermally tive medium used can also be an um— infused medicinal/therapeutic cream, ointment, or other compound.
In more variations, the second, polymeric, outer layer 15 of the bandage 10 is coupled about the periphery of the aluminum substrate 5, yet leaves most of the top surface of the aluminum substrate 5 uncovered so as to better allow heat thermally conducted from a burn wound h the um substrate 5 to dissipate via thermal convection and/or radiation to the ambient air.
In some alternate variations, a roll or sheet of aluminum substrate 5 is used t a d second layer 15, wherein the um substrate is applied over a burn wound, and is fixed into place around the edges of the application with l tape or gauze, while leaving most of the aluminum substrate 5 open to the air to facilitate heat dissipation.
Table 3 provides a list of some example form—factor dimensions used in some embodiments. It should be noted that this list is exemplary only, and is not intended to limit the scope of the inventive disclosure herein in any way.
TABLE 3: Exemplary Bandage Embodiment Dimensions Polymer outer Aluminum Effective Form Factor .
Base Slze. Substrate Slze. Coolmg Area.
Flgure Embodiment. 2 nces (mm x mm) (mm x mm) (mm ) Narrow 3A-4B; 13A—15; .4 x 76.2 20.3 x 35.5 714 Bandage Strip 18-19; 27; 31A 11A- R d d 52.1 x 76.2 43.2 x 50.8 2185 11B; 16-17;25— R “inec ang e61 26; 31B-31E 1A—2B; 11A— Rounded 63.5 x 88.9 50.8 x 63.5 11B; 16-17; 25- Rectangle 26; 31B-31E lA-ZB; 11A— 57.2 x 76.2 45.72 x 54.6 2500 11B; 16—17; 25— Rectangle 26; 31B-31E 1A—2B; 11A— 95.25 x 133.4 69.9 x 101.6 7099 11B; 16-17; 25— Rectangle 26; 31B-31E 85.1 x 93.4 58.4 x 69.9 2885 5A—6B;28; 31F In still more embodiments, the substantially polymeric and porous second layer 15 of the bandage 10 orates a thermochromic nd 40, 45, 70, or 80 (similar to what is typically found in mood rings) so that a user can actually see a visual indicator of the heat being removed from the user’s urn. In a variation, referring to Figures 13A-13B and -29, the top side of the aluminum substrate 5 has an extended member 5A that extends under the second layer 15 to be under and in direct contact with the thermochromic compound 40, 45, wherein the aluminum extension 5A provides thermal communication n a burn wound (via the aluminum substrate 5) and the thermochromic compound 40, 45. In another variation, referring to Figure 14, the top, d textured side of the aluminum ate 5 (that is, the heat—dissipation—enhancing topography side) has one or more thin aluminum strips 75 that are used to support and position a thermochromic indicator member 70 over the exposed top side of the aluminum substrate 5. In still more variations, referring to Figure 15, a small subset of the heat—dissipation protrusions on the top side of the aluminum substrate 5 are coated at their tip with thermochromic compound 80. In other variations, referring to Figures 16-19, the top side of the aluminum substrate 5 has a thermal— communication member 90 that extends to the thermochromic indicator 85, wherein the thermal—communication member 90 provides l communication between a burn wound (via the aluminum substrate 5) and the chromic indicator 85. In some embodiments, the thermal—communication member 90 can be an etched line of thermochromic paint or can be an aluminum conduit.
In some embodiments, the thermochromic indicators 40, 45, ’70, 80, 85 have compounds calibrated to indicate when a burn is sufficiently cooled (in some cases providing a color indicator; e. g., “green”; and/or an icon indicator; e. g., a “smilie face”) or still too warm (in some cases providing a color tor; e.g., “red”; and/or an icon indicator; e. g., a “frownie face”). In more variations, the thermochronic indicator 45 is in thermal communication with the aluminum substrate 5 via a thermally conductive extension 5A and will change color on the end that is more proximate to the um substrate 5 more quickly than on the other end of the chromic indicator 45 because of the thermal strata. Such stratification of the color change of the thermochromic indicator 45 helps a user gauge the rate and amount of g.
As an e, a user might apply an AluminaidTM bandage 10 to a burn from a hot pan, and initially, the user can see a red iconic thermochromic indicator 40, 70, 80, which indicates that a user should keep the AluminaidTM bandage 10 in place. Later, the pain subsides and the burned tissue cools, the user can see a green iconic thermochromic indicator 45, 70, 80, 85, which indicates to the user that the AluminaidTM e 10 can be safely changed out to a traditional medical dressing.
C. Details of AluminaidTM e Materials Refer to Figures 1A-31G.
Aluminum In many embodiments of bandages assuming a specific form factor (e.g., a finger— form—factor dressing, Figures 5A-6B, 28, and 31F), the first bandage layer 5 disposed to make direct contact with the burn wound covers approximately 30—100% of the entire length of the bandage 10. The outer edges of the product are reserved for a suitable adhesive which forms the bond n the outer sheath (cotton wool or polymer) and the aluminum ng.
The aluminum material used in the substrate 5 is generally comprised of at least 90% aluminum, and is essentially an amphoteric al. Other composites can occur as a result of naturally occurring processes and sometimes some contamination during manufacture.
However, none of these other additional substances are toxic in—relation to the scope of the prescribed application. In some ments, the aluminum material is ed in order to make the material more ductile to better facilitate various form factors. The annealing s includes gauging the um substrate 5 and specifically annealing it to e ity in order to optimally navigate the contours of body parts (e. g., finger and hands, but not excluding general—purpose forms, such as rectangle and square—shaped dressings).
In variations, the um may be subjected to electroplating or other non-toxic coating in order to facilitate ductility, improve performance, and enhance durability.
When aluminum combines with oxygen, the two elements o a spontaneous reaction: 4A1 (s) + 302 (g) --> 2A1203 (s) The properties of the aluminum used in some embodiments of the AluminaidTM bandages and wraps can be summarized as follows: 0 Main Composite: 2 90% aluminum, but is preferred to be 2 99% aluminum 0 In some embodiments, the aluminum used is an alloy comprised of Z 92% um and approximately 5% magnesium, with the balance of the alloy being naturally occurring impurities. This alloy is especially suited for a proprietary annealing process designed to enhance the ductility of the aluminum substrate used in bandages, discussed infra. o The atomic weigh of the aluminum used is approximately 26.98 AMU. 0 Form: Solid with ically formed ridges to maximize the available heat— er surfaces for cooling a wound. 0 Annealed: Yes, in order to optimally navigate the contours of body parts (e. g., fingers and hands, but not excluding l—purpose forms, such as rectangle and square—shaped dressings). In some embodiments, a proprietary annealing process is used, as discussed infra. 0 Thickness: S 1 mm, as measured from the bottom of the aluminum substrate to the average peak height of the plurality of heat—dissipation—enhancement protrusions/ridges on the top side of the substrate. In areas of the substrate between such heat—dissipation—enhancement protrusions/ridges, the thickness is S 0.1 mm. 0 l Conductivity: approximately 209 W/m'k i 10%. 0 Density: Z 2.699g/cm3. 0 Metallurgical Index: 8217 0 Toxicity: Non-toxic (aluminum-oxide layer coating) 0 Porosity: Defined as sufficient to enable the administration of a controlled release remedial substance, and/or to enable paths for oxygen to be uced to a burn wound. The um foil used must not exceed the defined thickness needed to ensure that the foil does not become impermeable to . Porosity can be obtained by either the inherent by—product of the aluminum—rolling process, or by mechanically introducing pinholes. Section III.B, supra, discusses some strategies for mechanically introducing aeration holes in the aluminum substrate beyond those that ly occur as a by-product of the manufacturing process. 0 Recycle: The aluminum alloy used in the substrate 5 can be recycled and can be made of recycled aluminum alloy.
Annealing ofAluminum In some embodiments, the aluminum substrate 5 is subjected to an annealing process to enhance the ductility and lity of the aluminum substrate as it is applied to various parts of a user body. It is a heat ent used to soften the aluminum alloys to that they can be easily worked and formed. The annealing process gives the resultant alloy a temper designation of “0”, which is very soft. In a variation, instead of quenching the aluminum material immediately after heating (as in the solution heat ent of aluminum process), the aluminum material is cooled in stages at specified temperatures.
In a lized embodiment, an aluminum alloy comprised of approximately 92% um and approximately 5% ium is used (with the remainder of the constituents being naturally ing impurities). Magnesium is added to the alloy because of its curative elements, its non-toxicity, and reasonable thermal conductivity (even though it is less than aluminum, it will not significantly degrade the alloy’ s overall thermal conductivity).
In a variation, the Aluminum—magnesium alloy is annealed to condition “1100—0”. It is annealed for approximately one hour at a temperature range of 775 °C — 900 °C. In some embodiments, the annealed aluminum alloy is furnace . r, in another embodiment, the aluminum alloy is then allowed to naturally cool; that is, non—furnace cool, thereby substantially removing any strain ing. The aluminum alloy re—crystallizes during this natural cooling process such that there is greater consistency in the direction of grain growth (that is, most, if not all, of the grains are oriented in a uniform direction), giving the material dramatically greater ity. These specialized fabrication techniques result in a d ance to thermal conductivity, or greater thermal—conductivity gain, as well as better malleability (less structural resistance at the atomic level). This re—crystallized aluminum alloy is used in some embodiments as the primary al for the aluminum substrate 5 in AluminaidTM bandages and wraps.
Perimeter Polymer Covering In some embodiments of bandages 10, one or more edges of the aluminum substrate 5 are coupled to a second layer 15 which extends beyond the boundaries of the aluminum ate 5 and typically has adhesive material disposed on its bottom surface to facilitate coupling to a user’s skin. A selection of materials commonly used in medical bandages may be used as an effective second layer 15, but a perforated r such as 1527-ENP ethylene vinyl acetate (EVA) is preferred in many embodiments.
In another embodiment, the second layer 15 is comprised of 3MTM TransporeTM Tape.
In many variations, the adhesive compound disposed on the exposed bottom side of the second layer 15 can be comprised of any non—toxic medical adhesive commonly used in the art, and in most variations, the bandage is stored with a peelable backing layer 14 detachably coupled to the adhesive on the second layer 15.
Thermochromic Compounds In some ions, the incorporated thermochromic materials 40, 45, 70, 80, 85 used in the outer bandage layers are comprised of thermochromic liquid crystals (for example, but not d to, cholesteryl ester carbonates, chiral nematic (non—sterol) aryl compounds, and (2—methylbutyl)phenol 4—alky1(oxy)benzoates) and/or leuco dyes/inks (for e, but not limited to, actones, fluorans, spiropyrans, and fulgides). In even more ions, the thermochromic-impregnated bandage materials are calibrated to y a "neutral" color at the average human skin temperature; that is, approximately 98.6 0F (37.0 0C).
In other variations, the thermochromic indicator materials 40, 45, 70, 80, 85 used can be a paint, a gel, or a thermochromic—compound—impregnated polymer.
In an embodiment, the chromic indicator material 40, 45, 70, 80, 85 comprises liquid crystals calibrated to display a green color indicator when the associated aluminum substrate has cooled to a ermined threshold, and also comprises liquid crystals calibrated to display a red color indicator when the associated um substrate exceeds a predetermined threshold.
IV. A e for 3 Burn Wound Embodiment In one embodiment, the inventive concept is directed to a bandage that is adapted to treat a burn wound. Refer to Figures 1A-31G, with an emphasis on Figures 20A-31G. In an embodiment, the bandage 10 comprises a first layer 5, substantially comprised of a thin lly conductive metal substrate 5, having a first surface and a second surface, wherein the metal substrate’s first surface has a profile, when viewed from the side, that is substantially flat and is adapted to make direct contact with a burn wound, and most of the metal substrate’s second surface has a non—flat, heat—dissipation—enhancing surface topography, when viewed from the side, that rises above the base plane of the aluminum substrate 5, adapted to be directly exposed to air. In variations, the thermally tive metal substrate 5 is substantially sed of a metal selected from the group consisting of aluminum, silver, gold, copper, ium, tungsten, platinum, and a metal alloy substantially based on any other aforementioned metals.
In another ion, the bandage 10 is further comprised of a second outer layer 15, substantially comprised of a ntially polymeric material, and a third intermediate layer 12, substantially comprised of absorbent material, each layer having a first surface and a second surface. In more variations, the third intermediate absorbent layer’s 12 first surface is adapted to mate with and cover at least two of the perimeter edges of the second e of the first layer 5, but leaving most of the first layer’s 5 second surface uncovered and exposed to the air, n: 0 The second outer layer’s 15 first surface is adapted to mate with and cover at least two of the perimeter edges of the second surface of the third layer 12, but also leaving most of the first layer’s 5 second surface uncovered and exposed to the air; 0 The second and third layers 15, 12 extend beyond at least two perimeter edges of the first layer 5; 0 The second outer layer 15 extends beyond the at least two perimeter edges of the third intermediate layer 12; 0 The at least two perimeter edges of the first layer 5 are bonded to a portion of the first surface of the third intermediate layer 12; 0 The at least two perimeter edges of the third intermediate layer 12 are bonded to a portion of the first surface of the second outer layer 15, 0 The remainder of the first surface of the second outer layer 15 is substantially coated with a non—toxic adhesive material adapted for use on user skin; and 0 The first, second, and third layers 5, 15, 12 are sized and shaped to a form factor that is adapted to one or more areas of a user body.
In an alternative variation, the e 10 can be fabricated without the absorbent, third ediate layer 12, n the second outer layer 15 extends beyond at least two perimeter edges of the first layer 5, and at least two edges of the first surface 5 are bonded to a portion of the first surface of the second outer layer 15. This variation would facilitate better overall ransfer properties of the bandage 10, though the lack of absorbent material about the perimeter of the bandage 10 may not be as desirable for oozing wounds.
This embodiment can be further enhanced wherein the non—flat, heat—dissipation— enhancing surface topography 5 includes a plurality of issipation—enhancing protrusions 7 (also, see, e.g., s 10A-10N), said protrusions selected from the group consisting of cone—like sions, half—dome—like protrusions, and pyramid—like protrusions. In variations, the plurality of heat—dissipation—enhancing protrusions 7 (also see, e. g., s 10A-10N) are ed in rows on the first layer 5, the positioning of every row with respect to its adjacent row(s) is selected from the group consisting of staggered and non—staggered.
In yet another variation, at least one heat—dissipation-enhancing protrusion 7 has a hole 6 disposed from its apex toward the base plane of the thermally conductive metal substrate 5, which aids in the bandage’s 10 thermal convection processes because of the added exposed surface area to air. In other ions, the first layer 5 includes a plurality of manufactured aeration holes 6 in the thermally conductive metal ate 5. In some applications, the at least one heat—dissipation—enhancing protrusion 7 with a hole 6 disposed from its apex toward the base plane of the thermally conductive metal substrate 5 has its hole extending all the way through the thermally tive metal substrate 5. In some cases, the hole 6 disposed in at least one heat—dissipation-enhancing protrusion 7 has a diameter that is narrower toward the second surface of the first layer 5 and wider toward the first surface of the first layer, which both aids in the thermal—convection properties of the substrate 5 and is formed by way of a two—step manufacturing stamping process wherein the main protrusion 7 are formed by a first stamping of the substrate 5 from the first surface toward the second surface, then a second stamping/punching at the apex of the formed protrusions 7 toward the first surface of the substrate 5 to form the openings 6. In some other cases, the holes 6 in the formed sions 7 are cylindrical in shape, maintaining approximately the same er along the length of the hole 6.
This embodiment can be enhanced wherein the material in the thermally conductive metal substrate 5 is sed of an aluminum alloy ning at least 92% aluminum and about 5% magnesium.
This embodiment can be enhanced wherein the aluminum alloy used in the first layer 5 is annealed by a s comprised of the steps of: 0 Subjecting the aluminum alloy to a temperature in the range of 775 °C to 900 °C; 0 Either subjecting the annealed aluminum alloy to furnace cooling or allowing the um alloy to naturally cool; that is, non—furnace cool. It should be noted, however, that the natural cooling step results in substantially removing any strain hardening of the aluminum alloy and ensuring that the re—crystallization of the aluminum alloy results in substantially uniform grain growth and directional orientation.
This embodiment can be further enhanced by further comprising a thermochromic tor member 45, wherein the thermochromic indicator member 45 is in thermal communication 5A with a burn wound Via the first layer 5, and the chromic tor member 45 is comprised of material calibrated to: 0 indicate to a user when a burn on which said bandage is applied is still too warm for safe l of said bandage, based on a predetermined threshold, and 0 indicate to a user when a burn has cooled to at least a ermined threshold such that said bandage can be safely removed and/or changed—out for a new medical dressing.
In variations, the thermochromic indicator member 45 provides color-based user indications as to the thermal status of the burn to which said bandage is applied. In other variations, the chromic indicator member 45 provides icon—based user indications as to the thermal status of the burn to which said bandage is applied. In some applications, the thermochromic indicator member 45 is comprised of material selected from the group consisting of thermochromic liquid crystals, leuco dyes, and thermochromic inks.
This ment can be further enhanced wherein the second layer 15 is ntially comprised of perforated 1527-ENP ethylene vinyl acetate (EVA).
This embodiment can be further enhanced wherein the third intermediate layer 12 is substantially comprised of a material selected from the group consisting of cotton cause, silk gauze, porous plastic gauze, and hydrogel.
This embodiment can be further enhanced wherein the form factor is adapted to facilitate bandage 10 application to a part of a human body selected from the group consisting of , thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face. In variations, the form factor is of a shape selected from the group consisting of rectangle, square, rounded— comer rectangle, circle, oval, triangle, rounded—corner le, and continuous-strip roll.
V. A Method of Making a Bandage for 3 Burn Wound Embodiment This embodiment is directed to a method of making a bandage adapted for treating burns and other wounds. Refer to Figures 1A-31G, with an emphasis on Figures 20A- 31G. The method comprises the step of ing a first layer 5, substantially sed of a thin thermally conductive metal ate 5, having a first surface and a second surface, n the metal substrate’s first surface has a profile, when viewed from the side, that is substantially flat and is adapted to make direct contact with a burn wound, and most of the metal substrate’s second surface has a non—flat, issipation—enhancing surface topography, when viewed from the side, that rises above the base plane of the aluminum substrate 5, adapted to be directly exposed to air. In variations, the thermally conductive metal substrate 5 is substantially sed of a metal selected from the group consisting of um, silver, gold, copper, magnesium, tungsten, platinum, and a metal alloy substantially based on any other aforementioned metals.
In another variation, the method is r comprised of the steps of providing a second outer layer 15, substantially comprised of a substantially polymeric material, and providing a third intermediate layer 12, substantially comprised of absorbent material, each layer having a first surface and a second surface. In more variations, the third intermediate absorbent s 12 first surface is adapted to mate with and cover at least two of the perimeter edges of the second surface of the first layer 5, but leaving most of the first layer’s second e uncovered and exposed to the air, wherein: 0 The second outer layer’s 15 first e is adapted to mate with and cover at least two of the perimeter edges of the second surface of the third layer 12, but also leaving most of the first layer’s 5 second surface uncovered and exposed to the air; 0 The second and third layers 15, 12 extend beyond at least two perimeter edges of the first layer 5; 0 The second outer layer 15 extends beyond the at least two perimeter edges of the third intermediate layer 12; 0 The at least two perimeter edges of the first layer 5 are bonded to a portion of the first e of the third intermediate layer 12; 0 The at least two perimeter edges of the third intermediate layer 12 are bonded to a portion of the first surface of the second outer layer 15, 0 The remainder of the first surface of the second outer layer 15 is substantially coated with a non—toxic adhesive material adapted for use on user skin; and 0 The first, second, and third layers 5, 15, 12 are sized and shaped to a form factor that is adapted to one or more areas of a user body.
In an alternative variation, the bandage 10 can be fabricated without the ent, third intermediate layer 12, wherein the second outer layer 15 s beyond at least two perimeter edges of the first layer 5, and at least two edges of the first surface 5 are bonded to a portion of the first surface of the second outer layer 15. This ion would facilitate better overall heat—transfer properties of the bandage 10, though the lack of absorbent material about the perimeter of the bandage 10 may not be as desirable for oozing wounds.
This embodiment can be further enhanced wherein the non—flat, heat—dissipation— enhancing surface topography 5 includes the manufacturing step of providing a plurality of heat—dissipation—enhancing protrusions 7 (also, see, e.g., Figures 10A-10N), said protrusions ed from the group consisting of cone—like sions, half—dome-like protrusions, and pyramid—like protrusions. In ions, the plurality of heat—dissipation—enhancing protrusions 7 (also see, e.g., Figures 10A-10N) are disposed in rows on the first layer 5, the positioning of every row with respect to its nt row(s) is selected from the group consisting of red and non—staggered. In yet another variation, at least one heat— dissipation—enhancing protrusion 7 is provided with a hole 6 disposed from its apex toward the base plane of the thermally conductive metal substrate 5, which aids in the bandage’s 10 l convection processes because of the added exposed surface area to air. In other variations, the first layer 5 es the step of providing a plurality of manufactured aeration holes 6 in the thermally conductive metal substrate 5. In some applications, the at least one heat—dissipation-enhancing protrusion 7 with a hole 6 disposed from its apex toward the base plane of the thermally tive metal substrate 5 has its hole extending all the way through the thermally tive metal substrate 5. In some cases, the hole 6 ed in at least one heat—dissipation—enhancing protrusion 7 has a diameter that is narrower toward the second surface of the first layer 5 and wider toward the first surface of the first layer, which both aids in the thermal—convection properties of the substrate 5 and is formed by way of a two—step manufacturing stamping process wherein the main protrusion 7 are formed by a first stamping of the substrate 5 from the first surface toward the second e, then a second stamping/punching at the apex of the formed protrusions 7 toward the first surface of the substrate 5 to form the openings 6. In some other cases, the holes 6 in the formed protrusions 7 are cylindrical in shape, maintaining approximately the same er along the length of the hole 6.
This embodiment can be enhanced wherein the material in the thermally conductive metal substrate 5 is comprised of an um alloy containing at least 92% aluminum and about 5% magnesium.
This embodiment can be enhanced wherein the aluminum alloy used in the first layer 5 is annealed by a process comprised of the steps of: 0 Subjecting the aluminum alloy to a temperature in the range of 775 °C to 900 °C; and 0 Either ting the annealed aluminum alloy to furnace cooling or allowing the aluminum alloy to naturally cool; that is, non—furnace cool. It should be noted, r, that the natural cooling step results in ntially removing any strain hardening of the aluminum alloy and ensuring that the re—crystallization of the aluminum alloy results in substantially uniform grain growth and directional orientation.
This embodiment can be further enhanced by further comprising the step of providing a thermochromic indicator member 45, wherein the thermochromic tor member 45 is in thermal communication 5A with a burn wound via the first layer 5, and the thermochromic indicator member 45 is comprised of material calibrated to: 0 indicate to a user when a burn on which said bandage is applied is still too warm for safe l of said bandage, based on a predetermined threshold, and 0 indicate to a user when a burn has cooled to at least a predetermined threshold such that said bandage can be safely removed and/or changed—out for a new medical dressing.
In variations, the thermochromic tor member 45 provides color—based user indications as to the thermal status of the burn to which said bandage is applied. In other variations, the chromic indicator member 45 provides icon—based user indications as to the thermal status of the burn to which said bandage is applied. In some applications, the thermochromic tor member 45 is comprised of material selected from the group consisting of thermochromic liquid crystals, leuco dyes, and thermochromic inks.
This embodiment can be further ed wherein the second layer 15 is substantially comprised of ated 1527—ENP ethylene vinyl acetate (EVA).
This ment can be further enhanced wherein the third intermediate layer 12 is substantially sed of a material selected from the group consisting of cotton cause, silk gauze, porous plastic gauze, and hydrogel.
This embodiment can be further enhanced wherein the form factor is adapted to facilitate bandage 10 application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face. In variations, the form factor is of a shape selected from the group consisting of rectangle, square, rounded— comer rectangle, circle, oval, triangle, rounded—corner triangle, and uous—strip roll.
VI. A Method of Using a Bandage for 3 Burn Wound ment This embodiment is directed to a method of using a bandage according to either Section III or Section IV, supra, adapted for treating burns and other wounds. Refer to Figures 1A-31G, with an emphasis on Figures 20A-31G. It should be noted that this particular embodiment pertains to bandages without a second or third layer 15, 12. The method comprises the steps of: 0 Obtaining a bandage 10 according to either Section III or Section IV, supra; and WO 19372 0 Applying the bandage 10 to a burn wound 60 with the first surface of the first layer 5 in direct contact with said burn wound 60; and 0 Securing the bandage 10 in position over the burn wound 60 by applying adhesive medical tape along some or all of the edges of the e 10 and extending to the tissue surrounding non—burned tissue, wherein the top side of the bandage first layer 5 is mostly left uncovered and d to the ambient environment.
This embodiment can be further enhanced wherein the non—flat, heat—dissipation— enhancing surface topography 5 includes a plurality of heat—dissipation—enhancing sions 7 (also, see, e.g., s 10A-10N), said protrusions ed from the group consisting of cone—like protrusions, half—dome—like protrusions, and pyramid—like protrusions. In variations, the plurality of heat—dissipation—enhancing sions 7 (also see, e. g., Figures 10A-10N) are disposed in rows on the first layer 5, the positioning of every row with respect to its adjacent row(s) is selected from the group consisting of red and aggered.
In yet another variation, at least one heat—dissipation—enhancing protrusion 7 has a hole 6 disposed from its apex toward the base plane of the thermally conductive metal substrate 5, which aids in the bandage’s 10 thermal convection processes because of the added exposed surface area to air. In other variations, the first layer 5 includes a plurality of manufactured aeration holes 6 in the thermally conductive metal substrate 5. In some applications, the at least one heat—dissipation—enhancing protrusion 7 with a hole 6 disposed from its apex toward the base plane of the thermally conductive metal substrate 5 has its hole extending all the way through the thermally conductive metal substrate 5 In some cases, the hole 6 disposed in at least one heat—dissipation-enhancing protrusion 7 has a diameter that is narrower toward the second surface of the first layer 5 and wider toward the first surface of the first layer, which both aids in the thermal—convection properties of the substrate 5 and is formed by way of a two—step manufacturing stamping process wherein the main sion 7 are formed by a first stamping of the ate 5 from the first surface toward the second surface, then a second stamping/punching at the apex of the formed protrusions 7 toward the first surface of the substrate 5 to form the openings 6. In some other cases, the holes 6 in the formed protrusions 7 are cylindrical in shape, ining approximately the same diameter along the length of the hole 6.
This embodiment can be enhanced wherein the material in the thermally conductive metal substrate 5 is comprised of an aluminum alloy ning at least 92% aluminum and about 5% magnesium.
This embodiment can be enhanced wherein the aluminum alloy used in the first layer 5 is annealed by a process sed of the steps of: 0 Subjecting the aluminum alloy to a temperature in the range of 775 °C to 900 °C; 0 Either subjecting the annealed aluminum alloy to furnace cooling or allowing the aluminum alloy to naturally cool; that is, non—furnace cool. It should be noted, r, that the natural cooling step results in substantially removing any strain hardening of the aluminum alloy and ensuring that the re—crystallization of the aluminum alloy results in substantially uniform grain growth and directional ation.
This embodiment can be enhanced wherein the e r comprises a thermochromic indicator member 45, wherein: 0 The thermochromic indicator member 45 is in thermal communication 5A with a burn wound via the first layer 5, and 0 The thermochromic tor member 45 is comprised of material ated to indicate to a user when a burn on which the bandage 10 is d is still too warm for safe removal of said bandage, based on a predetermined threshold, and indicate to a user when a burn has cooled to at least a predetermined threshold such that the bandage 10 can be safely removed and/or changed—out for a new medical dressing.
This embodiment can be enhanced wherein the chromic indicator member 45 provides color—based user indications as to the l status of the burn to which the bandage 10 is applied.
This embodiment can be enhanced wherein the thermochromic indicator member 45 provides icon—based user indications as to the thermal status of the burn to which the bandage 10 is applied.
This ment can be enhanced wherein the thermochromic indicator member 40, 45, 70, 80, 85 is comprised of material selected from the group consisting of thermochromic liquid crystals, leuco dyes, and thermochromic inks.
This embodiment can be enhanced by further comprising the steps of: 0 Observing the thermochromic indicator member 45; 2012/046310 0 If the therrnochromic indicator member 45 indicates that the burn wound 60 is too warm, then continuing the application of the bandage 10 on the burn wound 60 to further cooling of the burn wound 60; 0 If the thermochromic indicator member 45 indicates that the burn wound 60 has cooled sufficiently, then removing the bandage 10 from the burn wound 60 and ng a different medical dressing to the burn wound 60; and 0 Repeating the previous steps as necessary until the bandage 10 has been removed from the burn wound 60.
This embodiment can be enhanced wherein the different l dressing referred to above is any one or combination of dressings selected from the group consisting of medicinal compounds, therapeutic compounds, and sterile gauze—based or cotton—based bandages.
This embodiment can be further enhanced wherein the form factor is adapted to facilitate bandage 10 application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face. In variations, the form factor is of a shape ed from the group consisting of rectangle, square, rounded— corner rectangle, circle, oval, triangle, rounded—corner le, and continuous—strip roll.
This embodiment can be enhanced by further sing the step of subjecting the exposed aluminum substrate 5 of the applied bandage 10 to forced—air g in order to speed cooling of the burn wound 60.
VII. A Method of Using a Bandage for 3 Burn Wound Embodiment This embodiment is directed to a method of using a bandage according to either Section III or Section IV, supra, adapted for treating burns and other wounds. Refer to Figures 1A-31G, with an emphasis on Figures 20A-31G. It should be noted that this particular ment pertains to bandages with at least a second layer (and gossibly a third layer) 15, 12. The method comprises the steps of: 0 Obtaining a e 10 according to either Section III or Section IV, supra; and 0 Applying the bandage 10 to a burn wound 60 with the first surface of the first layer 5 in direct t with said burn wound 60; and 0 ng the bandage 10 in position over the burn wound 60 with the adhesive material disposed on the first side of the second layer 15 of the bandage 10.
This embodiment can be further enhanced wherein the non—flat, heat—dissipation— enhancing surface topography 5 includes a plurality of heat—dissipation—enhancing protrusions 7 (also, see, e.g., Figures 10A-10N), said protrusions selected from the group consisting of cone—like protrusions, ome—like protrusions, and pyramid—like protrusions. In variations, the plurality of heat—dissipation-enhancing sions 7 (also see, e. g., Figures 10A-10N) are disposed in rows on the first layer 5, the positioning of every row with respect to its adjacent row(s) is selected from the group consisting of staggered and non—staggered.
In yet r variation, at least one issipation—enhancing sion 7 has a hole 6 ed from its apex toward the base plane of the thermally conductive metal substrate 5, which aids in the bandage’s 10 thermal convection processes because of the added exposed surface area to air. In other variations, the first layer 5 includes a plurality of manufactured on holes 6 in the thermally conductive metal substrate 5. In some applications, the at least one heat—dissipation-enhancing protrusion 7 with a hole 6 disposed from its apex toward the base plane of the thermally conductive metal substrate 5 has its hole extending all the way through the thermally conductive metal substrate 5. In some cases, the hole 6 disposed in at least one heat—dissipation—enhancing protrusion 7 has a diameter that is narrower toward the second surface of the first layer 5 and wider toward the first surface of the first layer, which both aids in the thermal—convection properties of the substrate 5 and is formed by way of a two—step cturing stamping s wherein the main protrusion 7 are formed by a first stamping of the substrate 5 from the first surface toward the second surface, then a second stamping/punching at the apex of the formed protrusions 7 toward the first surface of the ate 5 to form the openings 6. In some other cases, the holes 6 in the formed protrusions 7 are cylindrical in shape, maintaining approximately the same diameter along the length of the hole 6.
This embodiment can be enhanced wherein the material in the thermally conductive metal substrate 5 is comprised of an aluminum alloy containing at least 92% aluminum and about 5% magnesium.
This embodiment can be enhanced wherein the aluminum alloy used in the first layer 5 is annealed by a process comprised of the steps of: 0 Subjecting the aluminum alloy to a temperature in the range of 775 °C to 900 °C; 0 Either ting the annealed aluminum alloy to furnace cooling or ng the aluminum alloy to naturally cool; that is, non—furnace cool. It should be noted, however, that the natural g step results in substantially removing any strain hardening of the aluminum alloy and ensuring that the re—crystallization of the um alloy results in substantially uniform grain growth and directional orientation.
This embodiment can be enhanced wherein the bandage further comprises a thermochromic indicator member 45, wherein: 0 The thermochromic indicator member 45 is in thermal communication 5A with a burn wound Via the first layer 5, and 0 The thermochromic indicator member 45 is comprised of al calibrated to indicate to a user when a burn on which the bandage 10 is applied is still too warm for safe removal of said bandage, based on a predetermined threshold, and indicate to a user when a burn has cooled to at least a predetermined threshold such that the bandage 10 can be safely removed and/or changed—out for a new l dressing.
This embodiment can be enhanced wherein the thermochromic tor member 45 provides color—based user indications as to the thermal status of the burn to which the bandage 10 is applied.
This embodiment can be ed wherein the thermochromic indicator member 45 provides icon—based user indications as to the thermal status of the burn to which the bandage is applied.
This embodiment can be enhanced wherein the thermochromic indicator member 40, 45, 70, 80, 85 is comprised of material ed from the group consisting of chromic liquid crystals, leuco dyes, and thermochromic inks.
This embodiment can be ed by further sing the steps of: 0 Observing the thermochromic indicator member 45; 0 If the thermochromic indicator member 45 indicates that the burn wound 60 is too warm, then continuing the application of the bandage 10 on the burn wound 60 to further cooling of the burn wound 60; 0 If the thermochromic indicator member 45 indicates that the burn wound 60 has cooled sufficiently, then removing the bandage 10 from the burn wound 60 and ng a different medical dressing to the burn wound 60; and 0 ing the previous steps as necessary until the bandage 10 has been removed from the burn wound 60.
This embodiment can be ed wherein the different medical dressing referred to above is any one or combination of dressings selected from the group consisting of medicinal compounds, therapeutic compounds, and sterile based or cotton—based bandages.
This ment can be further enhanced n the form factor is adapted to facilitate bandage 10 application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face. In variations, the form factor is of a shape selected from the group consisting of rectangle, square, rounded— comer rectangle, circle, oval, triangle, rounded—corner triangle, and continuous-strip roll.
This embodiment can be further enhanced n the second layer 15 is substantially comprised of perforated 1527—ENP ethylene vinyl acetate (EVA).
This embodiment can be enhanced by further comprising the step of subjecting the exposed aluminum ate 5 of the applied e 10 to forced—air cooling in order to speed cooling of the burn wound 60.
Alternative Embodiments and Other Variations The various ments and variations thereof described herein (including the appended claims) and/or illustrated in the accompanying Figures are merely ary and are not meant to limit the scope of the inventive disclosure. It should be appreciated that us variations of the invention have been contemplated as would be obvious to one of ordinary skill in the art with the benefit of this disclosure.
Hence, those ordinarily skilled in the art will have no difficulty devising myriad obvious variations and improvements to the invention, all of which are intended to be encompassed within the scope of the description and Figures herein.
I/WE

Claims (58)

CLAIM :
1. A bandage for a burn wound, comprising: a first layer, substantially comprised of a thin thermally conductive metal substrate consisting of a single metal or alloy, having a first surface and a second surface, wherein said metal substrate's first surface has a profile that is substantially flat and adapted to make direct contact with a burn wound, and wherein said metal substrate's second surface has a profile that is a substantially nonflat , heat-dissipation-enhancing surface topography that rises above the plane formed by the said first e of said thermally tive metal substrate, and is adapted to be directly exposed to air.
2. The bandage of claim 1, wherein said thermally conductive metal substrate is substantially comprised of a metal selected from the group consisting of aluminum, silver, gold, copper, magnesium, tungsten, platinum, or a metal alloy substantially based on any other aforementioned metals.
3. The bandage of claim 1, further comprising a second outer layer, substantially comprised of a polymeric al, said second layer having a first surface and a second surface, wherein said second outer layer's first e is adapted to mate with and cover at least two of the edges of said second surface of said first layer, but also leaving said first s second surface substantially uncovered and exposed to the air, wherein said second layer extends beyond said at least two edges of said first layer, wherein said at least two edges of said first layer are bonded to a portion of the first surface of said second layer, wherein the remaining portion of the first surface of said second outer layer is ntially coated with a non-toxic ve material adapted for use on user skin, wherein said first and second layers are sized and shaped to a form factor that is adapted for use on one or more areas of a user body. AH26(11340928_1):MBS
4. The bandage of claim 1, further comprising a second outer layer, substantially sed of a ric material, and a third intermediate layer, substantially sed of absorbent material, each layer having a first surface and a second surface, wherein said third intermediate absorbent layer's first surface is adapted to mate with and cover at least two of the edges of said second surface of said first layer, but leaving said first layer's second surface substantially uncovered and exposed to the air, n said second outer layer's first surface is adapted to mate with and cover at least two of the edges of said second surface of said third layer, but also leaving said first layer's second surface substantially uncovered and exposed to the air, wherein said second and third layers extend beyond said at least two edges of said first layer, wherein said second outer layer extends beyond said at least two edges of said third intermediate layer, wherein said at least two edges of said first layer are bonded to a portion of the first surface of said third ediate layer, wherein said at least two edges of said third intermediate layer are bonded to a portion of the first surface of said second outer layer, wherein the remaining portion of the first surface of said second outer layer is substantially coated with a non-toxic adhesive material adapted for use on user skin, wherein said first, second, and third layers are sized and shaped to a form factor that is adapted for use on one or more areas of a user body.
5. The bandage of claim 1, wherein said non-flat, heat-dissipation-enhancing surface topography includes a plurality of heat-dissipation-enhancing protrusions, said sions selected from the group consisting of cone-like protrusions, ome-like protrusions, and pyramid-like sions.
6. The bandage of claim 5, wherein said plurality of heat-dissipation-enhancing AH26(11340928_1):MBS protrusions are disposed in rows on said first layer, the positioning of every row with respect to its adjacent row(s) is selected from the group consisting of staggered and non—staggered.
7. The bandage of claim 5, wherein at least one heat—dissipation—enhancing protrusion has 5 a hole disposed from its apex toward the base plane of said thermally conductive metal ate.
8. The bandage of claim 1, wherein said first layer includes a ity of manufactured aeration holes in said thermally conductive metal substrate.
9. The bandage of claim 7, wherein said at least one heat—dissipation—enhancing protrusion 10 with a hole ed from its apex toward the base plane of said thermally tive metal substrate has its hole ing all the way through said lly conductive metal ate.
10. The bandage of claim 9, wherein said hole disposed in at least one heat—dissipation— enhancing protrusion has a diameter that is narrower toward said second surface of said 15 first layer and wider toward said first surface of said first layer.
11. The bandage of claim 9, wherein said hole disposed in at least one issipation— enhancing protrusion has a diameter that is substantially the same size along the length of said hole.
12. The bandage of claim 1, wherein the material in said thermally conductive metal 20 substrate is comprised of an aluminum alloy containing at least 92% aluminum and about 5% magnesium.
13. The bandage of claim 12, wherein said aluminum alloy is annealed by a s comprising the step of subjecting said aluminum alloy to a temperature in the range of 775 °C to 900 °C. 25
14. The bandage of claim 13, further comprising the step of allowing said aluminum alloy to naturally cool; that is, non-furnace cool, thereby substantially removing any strain hardening of said aluminum alloy and ensuring that the re—crystallization of said aluminum alloy results in substantially uniform grain growth and directional orientation.
15. The bandage of claim 3, further comprising a thermochromic indicator member, wherein said chromic tor member is in thermal communication with a burn wound via said first layer, and n said thermochromic tor member is comprised of material calibrated to: 5 indicate to a user when a burn on which said bandage is applied is still too warm for safe removal of said bandage, based on a predetermined threshold, and indicate to a user when a burn has cooled to at least a predetermined threshold such that said bandage can be safely removed and/or changed—out for a new medical dressing. 10
16. The bandage of claim 15, wherein said thermochromic indicator member es color—based user indications as to the thermal status of the burn to which said e is applied.
17. The bandage of claim 15, wherein said thermochromic indicator member provides icon— based user indications as to the thermal status of the burn to which said bandage is 15 applied.
18. The bandage of claim 15, wherein said thermochromic tor member is comprised of material selected from the group consisting of thermochromic liquid crystals, leuco dyes, and chromic inks.
19. The bandage of claim 3, wherein said second layer is substantially comprised of 20 perforated 1527—ENP ethylene vinyl e (EVA).
20. The bandage of claim 3, wherein said form factor is adapted to facilitate bandage application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face.
21. The bandage of claim 3, wherein said form factor is of a shape selected from the group 25 consisting of rectangle, square, rounded—comer rectangle, circle, oval, triangle, rounded— corner triangle, and continuous-strip roll.
22. The bandage of claim 4, further comprising a thermochromic indicator member, wherein said chromic indicator member is in thermal communication with a burn wound via said first layer, and wherein said thermochromic tor member is comprised of material calibrated to: indicate to a user when a burn on which said e is applied is still too warm for safe removal of said bandage, based on a predetermined threshold, and indicate to a user when a burn has cooled to at least a predetermined threshold such that said bandage can be safely removed and/or changed-out for a new medical dressing.
23. The bandage of claim 22, wherein said thermochromic indicator member provides ased user indications as to the thermal status of the burn to which said bandage is d.
24. The e of claim 22, wherein said thermochromic indicator member provides iconbased user indications as to the thermal status of the burn to which said bandage is applied.
25. The bandage of claim 22, wherein said thermochromic indicator member is comprised of material selected from the group consisting of thermochromic liquid ls, leuco dyes, and thermochromic inks.
26. The bandage of claim 4, wherein said second layer is substantially comprised of perforated 1527-ENP ethylene vinyl acetate (EVA).
27. The bandage of claim 4, wherein said third intermediate layer is substantially comprised of a material selected from the group consisting of cotton cause, silk gauze, porous plastic gauze, and hydrogel.
28. The bandage of claim 4, n said form factor is adapted to facilitate bandage application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face.
29. The bandage of claim 4, wherein said form factor is of a shape ed from the group consisting of rectangle, square, rounded-corner rectangle, circle, oval, triangle, roundedcorner triangle, and continuous-strip roll.
30. A method of making a bandage for a burn wound, comprising the steps of: AH26(11340928_1):MBS a) manufacturing a thin thermally conductive metal substrate consisting of a single metal or alloy, having a first e and a second e, wherein said metal substrate's first e has a profile, when viewed from the side, that is substantially flat and adapted to make direct contact with a burn wound, and wherein most of said metal substrate's second surface has a non-flat, heat-dissipationenhancing surface topography, when viewed from the side, that rises above the base plane of said thermally conductive metal substrate, and is adapted to be directly exposed to air, and b) coupling said thin thermally conductive metal substrate to an adhesive material to facilitate adhesive coupling to the skin, whereby the ve material extends beyond the perimeter of the thin thermally conductive material surface.
31. The method of claim 30, wherein said thermally conductive metal substrate is substantially comprised of a metal selected from the group consisting of aluminum, silver, gold, copper, magnesium, tungsten, platinum, and a metal alloy substantially based on any other aforementioned metals.
32. The method of claim 30, further comprising the step of ing a second outer layer, substantially sed of a polymeric material, said second layer having a first surface and a second surface, wherein said second outer layer's first surface is adapted to mate with and cover at least two of the edges of said second e of said first layer, but also leaving said first s second surface substantially uncovered and exposed to the air, wherein said second layer extends beyond said at least two edges of said first layer, wherein said at least two edges of said first layer are bonded to a portion of the first surface of said second layer, wherein the remaining portion of the first surface of said second outer layer is substantially coated with a non-toxic ve material adapted for use on user skin, AH26(11340928_1):MBS n said first and second layers are sized and shaped to a form factor that is d for use on one or more areas of a user body.
33. The method of claim 30, further comprising the steps of ing a second outer layer substantially comprised of a polymeric material, and providing a third intermediate layer, substantially comprised of absorbent material, each layer having a first surface and a second surface, wherein said third intermediate absorbent layer's first surface is adapted to mate with and cover at least two of the edges of said second surface of said first layer, but leaving said first layer's second surface substantially uncovered and exposed to the air, n said second outer layer's first surface is adapted to mate with and cover at least two of the edges of said second surface of said third layer, but also leaving said first layer's second surface substantially uncovered and exposed to the air, wherein said second and third layers extend beyond said at least two edges of said first layer, wherein said second outer layer s beyond said at least two edges of said third intermediate layer, wherein said at least two perimeter edges of said first layer are bonded to a portion of the first surface of said third intermediate layer, wherein said at least two edges of said third intermediate layer are bonded to a portion of the first surface of said second outer layer, wherein the remaining portion of the first surface of said second outer layer is substantially coated with a non-toxic adhesive material adapted for use on user skin, wherein said first, second, and third layers are sized and shaped to a form factor that is adapted to one or more areas of a user body.
34. The method of claim 30, n said non-flat, heat-dissipation-enhancing surface topography includes a plurality of issipation-enhancing protrusions, said protrusions AH26(11340928_1):MBS selected from the group consisting of cone-like protrusions, half-dome-like protrusions, and pyramid-like protrusions.
35. The method of claim 34, wherein said plurality of heat-dissipation-enhancing protrusions are disposed in rows on said first layer, the positioning of every row with t to its adjacent row(s) is selected from the group consisting of staggered and non-staggered.
36. The method of claim 34, wherein at least one heat-dissipation-enhancing protrusion has a hole disposed from its apex toward the base plane of said thermally conductive metal substrate.
37. The method of claim 30, wherein said first layer includes a plurality of manufactured aeration holes in said thermally conductive metal substrate.
38. The method of claim 36, wherein said at least one heat-dissipation-enhancing protrusion with a hole disposed from its apex toward the base plane of said thermally conductive metal substrate has its hole extending all the way through said thermally conductive metal substrate.
39. The method of claim 38, wherein said hole disposed in at least one heat-dissipationenhancing protrusion has a diameter that is er toward said second surface of said first layer and wider toward said first surface of said first layer.
40. The method of claim 38, wherein said hole disposed in at least one heat-dissipationenhancing sion has a diameter that is substantially the same size along the length of said hole.
41. The method of claim 30, wherein the material in said thermally tive metal substrate is comprised of an aluminum alloy containing at least 92% aluminum and about 5% ium.
42. The method of claim 41, wherein said um alloy is annealed by a process comprising the step of subjecting said aluminum alloy to a temperature in the range of 775 °C to 900 AH26(11340928_1):MBS
43. The method of claim 42, further comprising the step of allowing said aluminum alloy to naturally cool; that is, non-furnace cool, thereby substantially removing any strain hardening of said aluminum alloy and ensuring that the re-crystallization of said aluminum alloy results in substantially uniform grain growth and directional orientation.
44. The method of claim 32, further comprising the step of providing a thermochromic indicator member, wherein said thermochromic indicator member is in thermal communication with a burn wound via said first layer, and wherein said chromic indicator member is comprised of al calibrated to: indicate to a user when a burn on which said bandage is applied is still too warm for safe removal of said bandage, based on a predetermined threshold, and te to a user when a burn has cooled to at least a predetermined threshold such that said bandage can be safely removed and/or changed-out for a new medical dressing.
45. The method of claim 32, wherein said thermochromic indicator member provides colorbased user indications as to the thermal status of the burn to which said e is applied.
46. The method of claim 32, n said thermochromic indicator member provides iconbased user indications as to the l status of the burn to which said bandage is applied.
47. The method of claim 32, n said thermochromic indicator member is comprised of material selected from the group ting of thermochromic liquid crystals, leuco dyes, and thermochromic inks.
48. The method of claim 32, wherein said second layer is substantially comprised of perforated 1527-ENP ethylene vinyl acetate (EVA). AH26(11340928_1):MBS
49. The method of claim 32, wherein said form factor is adapted to facilitate bandage application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face.
50. The method of claim 32, wherein said form factor is of a shape ed from the group consisting of rectangle, , rounded-comer gle, circle, oval, triangle, roundedcomer triangle, and continuous-strip roll.
51. The method of claim 33, further comprising the step of providing a thermochromic tor member, wherein said thermochromic indicator member is in thermal communication with a burn wound via said first layer, and wherein said thermochromic indicator member is comprised of material calibrated to: indicate to a user when a burn on which said bandage is applied is still too warm for safe removal of said bandage, based on a predetermined threshold, and indicate to a user when a burn has cooled to at least a predetermined threshold such that said bandage can be safely removed and/or changed-out for a new medical dressing.
52. The method of claim 51, wherein said thermochromic indicator member provides colorbased user indications as to the thermal status of the burn to which said bandage is applied.
53. The method of claim 51, wherein said thermochromic indicator member provides iconbased user indications as to the thermal status of the burn to which said bandage is applied.
54. The method of claim 51, n said thermochromic indicator member is sed of material ed from the group consisting of thermochromic liquid crystals, leuco dyes, and thermochromic inks.
55. The method of claim 33, wherein said second layer is substantially comprised of perforated 1527-ENP ethylene vinyl acetate (EVA). AH26(11340928_1):MBS
56. The method of claim 33, wherein said third intermediate layer is substantially comprised of a material ed from the group consisting of cotton cause, silk gauze, porous plastic gauze, and hydrogel.
57. The method of claim 33, wherein said form factor is adapted to facilitate e application to a part of a human body selected from the group consisting of finger, thumb, toe, elbow, wrist, knee, ankle, foot, hand palm, and face.
58. The method of claim 33, wherein said form factor is of a shape selected from the group consisting of rectangle, square, rounded-comer rectangle, , oval, triangle, roundedcomer triangle, and continuous-strip roll. Aluminaid International, AG Carl Freer Ericka Freer Terrence Wyles By the Attorneys for the Applicant SPRUSON & FERGUSON Per: AH26(11340928_1):MBS WO 19372 BOTTOM WO 19372 BOTTOM WO 19372 PCT/U
NZ704069A 2011-07-29 2012-07-11 Thermally-conductive, metal-based bandages to aid in medical healing and methods of use NZ704069B2 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201161513366P 2011-07-29 2011-07-29
US61/513,366 2011-07-29
USPCT/US2011/067256 2011-12-23
PCT/US2011/067256 WO2013019266A1 (en) 2011-07-29 2011-12-23 Aluminum-based bandages to aid in medical healing and methods of use
US201261670090P 2012-07-10 2012-07-10
US61/670,090 2012-07-10
PCT/US2012/046310 WO2013019372A2 (en) 2011-07-29 2012-07-11 Thermally-conductive, metal-based bandages to aid in medical healing and methods of use

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NZ704069A NZ704069A (en) 2016-10-28
NZ704069B2 true NZ704069B2 (en) 2017-01-31

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