# Patent

## Title
Eye treatment compress

## Abstract

A method of providing moisture therapy to a subject by applying a moist therapy compress against a treated body portion. The moist therapy compress includes a fluid-permeable shell, a flexible backing fastened to the shell to define an enclosure, and a hydrophilic zeolite fill granules loosely contained within the enclosure. The therapy compress is exposed to a source of moisture to cause absorption of water into the a hydrophilic zeolite, and the moisture is delivered from the hydrophilic zeolite through the fluid permeable shell to the treated body portion.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. Non-Provisional patent application Ser. No. 13/291,059 filed Nov. 7, 2011, which is a continuation of U.S. Non-Provisional patent application Ser. No. 10/380,803, filed May 30, 2003, which is a US. National Phase of International Patent Application Serial No. PCT/US2001/028908, filed on Sep. 17, 2001, which claims priority to and the benefit of the filing date of U.S. Patent Application No. 60/232,826, filed on Sep. 15, 2000, in the United States Patent and Trademark Office, all of which are hereby incorporated herein by reference.


FIELD OF THE INVENTION
The present invention relates generally to medical treatment devices and therapeutic methods, and more particularly to moist-heat therapy compresses and wound dressings, and to a wound dressing and/or heat-therapy compress containing antimicrobial metal(s) providing a germ and microbial free environment within the article and treated areas.
BACKGROUND
Modern wound dressings are designed to promote healing by providing a moist, warm or heated, wound environment. Warming a wound promotes healing by increasing blood flow to the area. Moisture in a wound is also very important to the healing process because it helps cells grow and divide, and reduces scarring. Available modem dressings may be dampened or moistened and then heated, for example, by microwave heating. Concurrent with the development of these dressings is the concern regarding a potential for microbial colonization of the wound. Antibiotics are available to combat infections but many people are allergic to certain antibiotics and antibiotic usage can cause gastrointestinal upset or other side effects. Further, excessive use of antibiotics has been blamed for the occurrence of treatment-resistant bacteria.
Moist heat therapy applied by an area compress may also be beneficial to the treatment of arthritic or sprained joints, strained muscles, back pain, rheumatoid arthritis, or in any treatment where heat might be applied through or to the skin to promote circulation therein and thereunder. In such applications where no wound exudates contaminate therapy materials, reusability of the compress is an attractive cost-efficient design feature. Bacterial presence can cause dermatological problems to the treated area and further, a growing microbial colony in a reusable compress can cause the spread of infection through cross-contamination when handled. This may represent a particular threat to therapy patients, many of whom have persistent or slow-healing injuries or compromised immunity systems.
A growing strategy for reducing the potential for infection or bacterial growth in a wound or on skin tissue under moist heat therapy is the incorporation of noble metal antimicrobials into the therapeutic wound dressing. The most prevalent such metal in use is silver due to its relative lack of cytotoxic effects and wide spectrum of antimicrobial effectiveness. Medical materials and instruments are available which provide the emission of silver metal or silver compounds to provide an antimicrobial effect. Such available dressings, once moistened, release silver into the surrounding liquid. The dressing thereby becomes an effective antimicrobial barrier. The silver, however, is consumed and lost in the process. Such products are inherently not conveniently reusable.
In both moist heat therapy wound dressings and compresses, bacterial and fungal growth can also cause unpleasant odor and unsightly discoloration which may adversely affect the morale of the patient. Thus there is a need in general for dressings and compresses designed to maintain sterility therein and to also provide microbial free moisture.
SUMMARY
In example embodiments, the present invention provides a wound dressing and/or therapy compress having a granular fill material permanently loaded with at least one antimicrobial agent. The at least one antimicrobial agent comprises a form of silver, which form of silver may comprise atomic silver or a composition of silver. The dressing or compress thus comprises a fluid permeable shell and a backing, each of which is attached to the other to define a plurality of fill enclosures therebetween, and a fill material enclosed within the respective enclosures. A fluid permeable outer cover may be provided to protect the dressing or compress. The dressing may be used to shelter and protect a wound while absorbing exudate, and may also provide and maintain a heated and/or moist environment to promote the healing of the wound. The compress may be used to deliver moist heat therapy to an arthritic or sprained joint or strained muscle area.
In other aspects, example embodiments of the invention relate to a wound dressing and/or therapy compress having a granular fill material such as a hydrophilic zeolite or molecular sieve material, optionally loaded with at least one metallic antimicrobial agent, such as for example a silver, copper, copper oxide, gold, magnesium oxide, aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel, zirconium, molybdenum, tin, lead and/or other metals, metal oxides, metal ions, metal particles or nanoparticles, and alloys, mixtures or combinations thereof. The dressing or compress preferably comprises a flexible and body part conformable treatment device having a fluid-permeable shell and a backing, each of which is attached to the other to define at least one, and preferably a plurality of fill enclosures therein, and a particulate fill material enclosed and loosely contained within the respective enclosure(s). A fluid-permeable removable and replaceable outer cover may optionally be provided to protect the dressing or compress.
The fill material may be prepared wet or moistened, or desiccated to dryness to either deliver or absorb moisture as appropriate to the desired treatment. The fill material absorbs or delivers this moisture through the lower shell. The shell is formed to be fluid-permeable, i.e., vapor-permeable and liquid-permeable, and is adapted to be placed in contact with a wound or tissue directly or through a vapor-permeable and liquid-permeable outer cover. The backing may also be fluid-permeable, or non-permeable if so desired, so as to allow for the release or retention of moisture as appropriate to the desired treatment.
The shell and backing are joined to form at least one, and preferably a plurality of enclosures there between. The enclosures may contain the loaded fill material. The presence of the antimicrobial agent within all or some of the fill material promotes a germ and microbial free environment at and near the lower shell and within the dressing or compress. The device and its constituent components are preferably water resistant and microwave safe, whereby the device can safely be subjected to repeated cycles of wetting, microwave heating and cooling, without significant deterioration or loss of its moist heat therapy, antimicrobial or antibacterial characteristics. The dressing or compress may be washable and reusable.
These and other aspects, features and advantages of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following brief description of the drawings and detailed description of the invention are exemplary and explanatory of preferred embodiments of the invention, and are not restrictive of the invention, as claimed.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial side cross-sectional view of a dressing or compress according to an example embodiment of the present invention.
FIG. 2 is partial plan view of an exemplary hexagonal enclosure pattern according to an example embodiment of the present invention.
FIG. 3 is a plan view of an alternate exemplary dressing or compress with a hexagonal enclosure pattern.
FIG. 4 is a plan view of a wrap compress with ties using the dressing or compress of the present invention.
FIG. 5 is a plan view of a moist heat therapy compress in the form of an eye or nasal/sinus compress according to another example embodiment of the present invention.



DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein.
Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
Referring now to FIGS. 1-4, and as best illustrated in FIG. 1, a dressing or compress 100 is illustrated having a lower shell 102 and a flexible upper backing 104 which are joined or otherwise fastened to one another to form a series of enclosures 106 there between. The enclosures are provided for the containment and relatively uniform distribution of a plurality of fill granules 108 placed therein. The enclosures may be fashioned as filled pods which are draped from the backing. The shell 102 forms the contact surface of the dressing or compress used to drape or form the bottom of the filled enclosures which are to be placed against the tissue to be treated, and to conform to the shape of the treatment area. The backing forms the smoother outer surface of the dressing or compress facing away from the treatment area.
The enclosures 106 may be defined as hexagons using patterned seams 110 for local symmetry and efficient regular plane division. An illustrative hexagonal pattern 200 of enclosures 202 is illustrated in FIG. 2. The enclosures might also be fashioned as circles, octagons, or of any desired shape as may be appropriated for the desired treatment. The enclosures may be selectively sized as appropriate to the application. Each hexagonal shaped enclosure 202 has a lengthwise dimension 204 extending from a first corner to an opposite second corner thereof. For example, and not by way of limitation, this dimension may be in the range of from approximately one inch to approximately four inches in length. Large treatment areas such as the human torso or appendages may best be served with enclosures having a dimension 204 extending lengthwise for approximately 4 inches. Highly contoured areas such as the face may best be served with enclosures having a dimension 204 of approximately 1 inch in length.
An alternate dressing or compress 300 is illustrated in FIG. 3, having a plurality of hexagonal patterned enclosures 302. Each of the enclosures may also be formed as a channel-like rectangle, as illustrated in FIG. 4. The embodiment of the dressing or compress 400 is formed to have several channel enclosures 402 formed within a wrap compress having securing ties 404. So constructed, the dressing or compress 400 may be provided for the treatment of soreness or strains of the human back. In alternative applications, for example as illustrated in FIG. 5, the dressing or compress 500 is adapted for use as an eye compress for application of moist heat therapy to a subject's eyes with enclosures 502 for containing the fill granules and securing ties 504 for attachment around a patient's head, such as for treatment of dry-eye or other eye conditions; for moist heat therapy to a subject's sinus or nasal areas; and/or for treatment of other body parts of a human or animal subject or patient for wound care, epitheliazation, antibacterial, antimicrobial, antiviral, antifungal, anti-inflammatory, analgesic, moist heat therapy and/or other treatment purposes. In the eye compress configuration shown in FIG. 5, the flexible outer shell includes a generally triangular or trapezoidal nose cut-out area 506 at a medial portion of its lower edge, between first and second lobes 508a, 508b for covering areas over and around the user's left and right eyes when in use, with the ties or an elastic strap placed around the user's head, typically over the ears, to retain the compress 500 in place.
The size of the enclosures and overall dressing are selected to serve the desired treatment. Selected single sites for treatment such as the eye may best be treated using a single enclosure dressing or compress appropriately sized and shaped to rest comfortably in the eye hollow of the human face. The dressing or compress may be shaped as a regular or irregular polygon, any smooth closed curve, or any closed combination of line segments and smooth curves. The invention is not limited to constructions conforming to or only serving the human body. The invention provides a potentially useful treatment for the ailments of mammals and any animals benefiting from the healing properties of moisture and/or heat therapy.
A fluid-permeable, i.e., a vapor-permeable and/or a liquid-permeable protective outer cover (not illustrated) may be provided to encompass the compress. This may be preferable to limit contamination of the dressing or compress. For the treatment of open wounds, an uncovered disposable dressing (not illustrated) may be preferred for optimal formable contact with, and healing of, the exposed tissues. Alternatively, the cover and other materials of the compress or dressing are washable for repeated re-use.
The fill contained within the enclosure or enclosures may comprise a synthetic porous crystalline granular aluminosilicate zeolite, commonly used as a molecular sieve material, or other substances with similar properties. The fill material may further comprise other inert additives and physical matrices without affecting the antimicrobial and hydrous efficacies of the fill. Optionally, the wound dressing and/or therapy compress comprises a granular fill material such as a hydrophilic zeolite or molecular sieve material, with at least one metallic antimicrobial agent, such as for example a silver, copper, copper oxide, gold, magnesium oxide, aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel, zirconium, molybdenum, tin, lead and/or other metals, metal oxides, metal ions, metal particles or nanoparticles, and alloys, mixtures or combinations thereof deposited therein. For example, silver or other metal loading of the fill may be attained by the process of ion-exchange, as known. In this process, a solution containing atomic silver or a composition of silver bathes, or is passed through, a bed of the fill granules 108 (FIG. 1). An ion-exchange column method, as known in the art, may be performed in which an aqueous solution containing atomic silver or a composition of silver may be passed through a column bed of the fill granules, and the eluted solution may again be passed through the bed or may receive additional silver and then be again passed through the bed.
Various ion-exchange schedules known in the art may be applied to produce retention of the silver or other metals. For example, the final content by weight of the atomic silver or silver composition may be as high as twenty percent of the final loaded fill granules. The loaded fill granules produced by ion-exchange will exhibit high retention of the silver or other metals even under subsequent exposure to fluids and microwave irradiation. The fill granules may comprise a blend of both loaded and unloaded zeolite or a substance retaining silver or other metals. The presence of the atomic silver or other metals will not interfere with the useful properties of the fill granules such as the moisture desorption and adsorption properties which may be desirable in the use of the dressing or compress. The inherent hydrophilic nature of the zeolite provides that a substantial water content is available therein by absorption from the atmosphere. The water so absorbed may be sufficient, or may be supplemented by manually added water, for providing the microwave responsive water content of the dressing or compress. The compositions of silver or other metals used may include but are not limited to, metal compounds, and metal salts such as silver chloride and silver nitrate.
The presence of the silver or other metals within the fill granules contained in the enclosure of the invention provides anti-microbial properties to the dressing or compress. The ion-exchange loaded fill granules will retain the silver or other metals despite microwave heating as may be required in the use of the dressing or compress, which prevents the release of silver or other metals into a treated wound if the invention is used as a dressing. Further, the retention of the silver or other metals within the fill granules provides assured antimicrobial performance in a reusable and potentially washable, if so desired, moist heat therapy compress.
The compress or dressing of the present invention alternatively comprises fill granules such as a hydrophilic zeolite with or without anti-microbial metal(s) disposed therein. For wound dressing applications, the provision of anti-microbial metal(s) may be preferable. For therapeutic compress applications, the provision of anti-microbial metal(s) is optional. Moist heat therapy applied by an area compress may be beneficial to the treatment of arthritic or sprained joints, strained muscles, back pain, rheumatoid arthritis, or in any treatment where heat might be applied through or to the skin of a human or animal patient or subject, to promote circulation therein and there under. In such applications where no wound exudates contaminate (imbedded metals may not be incorporated into the molecular sieve granules when used for this purpose), reusability and ability to wash the compress are attractive cost-efficient design features. Thus, example embodiments of the invention comprise a washable and/or reusable compress.
In the described embodiments of the invention, the lower shell and the upper backing are each constructed of materials known in the art. Each may therefore be comprised of multilayered laminates, for example, with pore sizes selectable to meet the moisture transmission and retention properties desired for the specific treatment sought. The dressing or compress is adapted to be placed and to remain in intimate contact with the area to be treated to maintain a heated and/or moist environment thereabout. Dressing or compress constructions using woven textiles of natural fibers have been found to have limited spatial conformance to the various shapes, dimples, wrinkles and joints offered by the human body, although these materials may be used if so desired.
Accordingly, preferred dressing or compress constructions will use formable woven and non-woven synthetic materials or combinations thereof which may include, but are not limited to, synthetic olefin, polyester, urethane, and nylon. The shell and the backing may be fastened together across the area of the dressing or compress with a fill material, the fill granules 108, received there between. The shell and the backing may be fastened to one another by methods which may include, but are not limited to, adhesive attachment, RF welding, ultra-sonic attachment, sewing, or patterned heat application using a template or forming die to form a seal. To provide for the secure placement of the dressing or compress, peripheral or attachment fastening devices may be included which may comprise the desired number of Velcro®-type fasteners, adhesives, high tactility polymer materials, and/or material ties.
Throughout the construction of the dressing or compress, attention and care is taken in the selection of materials regarding thermal response to microwave heating. For design simplicity, all synthetic, microwave non-responsive materials may be selected to provide that the fill and/or water content of a moistened dressing or compress provide the only substantial thermal response to microwave irradiation.
Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific embodiments disclosed hereinabove, and that many modifications and other embodiments are intended to be included within the scope of the invention. Moreover, although specific terms are employed herein, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention. The words “a,” “an,” or “the” can mean one or more, depending upon the context in which the words are used hereinabove.

## Claims

1. An antimicrobial eye treatment compress for treatment of an eye of a human or animal patient comprising:
a flexible outer shell for application to an eye region of the patient, the outer shell forming at least one enclosure, and being microwave compatible for repeated microwave heating, the flexible outer shell being configured for treatment of dry-eye by application of moist heat therapy to the eye region of the patient, and comprising first and second lobes, said first and second lobes configured for application over and covering a respective left eye and right eye of the patient, and a nose cut-out region between the first and second lobes;
a plurality of hydrophilic zeolite fill granules loosely contained within the at least one enclosure and within each of the first and second lobes of the eye compress for delivery of moist heat from the hydrophilic zeolite fill granules through the flexible outer shell to the eye region of the patient when the first and second lobes of the eye compress are applied over the left and right eyes of the patient, the hydrophilic zeolite fill granules retaining at least one antimicrobial metal material disposed therein;
wherein the hydrophilic zeolite fill granules are microwave compatible and substantially retain said at least one antimicrobial metal material therein upon multiple exposures to microwave irradiation, but allow repeated absorption and dissipation of moisture to and from the hydrophilic zeolite fill granules.

2. The eye treatment compress of claim 1, wherein the outer shell comprise a synthetic fabric selected from synthetic olefin, polyester, urethane, nylon, and combinations thereof.

3. The eye treatment compress of claim 1, wherein the outer shell is fluid permeable.

4. The eye treatment compress of claim 1, wherein the outer shell is vapor permeable.

5. The eye treatment compress of claim 1, wherein the outer shell is liquid permeable.

6. The eye treatment compress of claim 1, wherein the at least one enclosure defines a geometric shape selected from a circle, an ellipse, a channel, and a polygon.

7. The eye treatment compress of claim 1, wherein the geometric shape is a hexagon.

8. The eye treatment compress of claim 1, wherein the at least one antimicrobial metal material is selected from silver, copper, copper oxide, gold, magnesium oxide, aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel, zirconium, molybdenum, tin, lead, metal oxides, metal ions, metal particles or nanoparticles, and alloys, mixtures and combinations thereof.

9. The eye treatment compress of claim 1, wherein the at least one antimicrobial metal material comprises silver.

10. The eye treatment compress of claim 1, wherein the at least one antimicrobial metal material comprises copper.

11. The eye treatment compress of claim 1, wherein the flexible outer shell is washable.

12. An eye treatment compress for treatment an eye of a human or animal patient comprising:
a flexible outer shell for application to an eye region of the patient, the outer shell forming at least one enclosure, and being microwave compatible for repeated microwave heating, the flexible outer shell being configured for treatment of dry-eye by application of moist heat therapy to the eye region of the patient, and comprising first and second lobes, the first and second lobes configured for application over and covering a left eye and right eye of the patient, and a nose cut-out region between the first and second lobes;
a plurality of hydrophilic zeolite fill granules loosely contained within the at least one enclosure and within the first and second lobes of the flexible outer shell for delivery of moist heat from the hydrophilic zeolite fill granules through the flexible outer shell to the eye region of the patient, the hydrophilic zeolite fill granules retaining at least one antimicrobial metal material disposed therein, wherein the at least one antimicrobial metal material is selected from silver, copper, copper oxide, gold, magnesium oxide, aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel, zirconium, molybdenum, tin, lead, metal oxides, metal ions, metal particles or nanoparticles, and alloys, mixtures and combinations thereof;
wherein the hydrophilic zeolite fill granules are microwave compatible and substantially retain said at least one antimicrobial metal material therein upon multiple exposures to microwave irradiation, but allow repeated absorption and dissipation of moisture to and from the hydrophilic zeolite fill granules.

13. The eye treatment compress of claim 12, wherein the at least one antimicrobial metal material comprises silver.

14. The eye treatment compress of claim 12, wherein the at least one antimicrobial metal material comprises copper.

15. The eye treatment compress of claim 12, wherein the flexible outer shell is washable.

16. A therapeutic eye compress for treatment of a human or animal patient comprising:
a microwave compatible flexible outer shell defining first and second lobes for application over and generally in contact with left and right eye regions of the patient and substantially covering a left eye and a right eye of the patient for treatment of dry-eye conditions, each of the first and second lobes comprising at least one enclosure;
a plurality of hydrophilic zeolite fill granules loosely contained within each of the at least one enclosures within the first and second lobes of the flexible outer shell, the flexible outer shell being moisture permeable and providing delivery of moist heat from the hydrophilic zeolite fill granules through the flexible outer shell to the left and right eye regions of the patient;
wherein the hydrophilic zeolite fill granules are microwave compatible for multiple exposures to microwave irradiation, and allow repeated absorption and dissipation of moisture to and from the hydrophilic zeolite fill granules.

17. The therapeutic compress of claim 16, wherein the hydrophilic zeolite fill granules have at least one antimicrobial metal material disposed therein.

18. A therapeutic eye compress for treatment of an eye region of a human or animal patient comprising:
a flexible outer shell having first and second lobes for substantially covering and at least partially contacting an eye region around left and right eyes of the patient, and a nose cut-out region between the first and second lobes, the outer shell forming at least one enclosure within each of the first and second lobes, and being microwave compatible for repeated microwave heating;
a plurality of hydrophilic zeolite fill granules loosely contained within each of the at least one enclosures in the first and second lobes for delivery of moist heat therapy from the hydrophilic zeolite fill granules through the flexible outer shell to the eye region of the patient, wherein the hydrophilic zeolite fill granules are microwave compatible for multiple exposures to microwave irradiation, and allow repeated absorption and dissipation of moisture to and from the hydrophilic zeolite fill granules.

19. The therapeutic eye compress of claim 18, wherein the hydrophilic zeolite fill granules have at least one antimicrobial metal material disposed therein.

20. The therapeutic eye compress of claim 19, wherein the at least one antimicrobial metal material is selected from silver, copper, copper oxide, gold, magnesium oxide, aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel, zirconium, molybdenum, tin, lead, metal oxides, metal ions, metal particles or nanoparticles, and alloys, mixtures and combinations thereof.

21. The therapeutic eye compress of claim 18, wherein the flexible outer shell is washable.