WO2008100647A9

WO2008100647A9 - Therapeutic cooling pad for ophthalmologic and cosmetic use

Info

Publication number: WO2008100647A9
Application number: PCT/US2008/050114
Authority: WO
Inventors: Barry J Linder
Original assignee: Bjl Medical Llc; Barry J Linder
Priority date: 2007-01-09
Filing date: 2008-01-03
Publication date: 2009-08-06
Also published as: WO2008100647A1

Abstract

This invention is directed to a therapeutic patch for ophthalmologic and cosmetic use that provides therapy to the region where the patch is provided; the therapeutic patch provides a therapeutic delivery surface for placement against, for example, the eyelid and peri-orbital structures of a patient, and a non-contacting surface that can be used, for example, to generate cooling and/or moisture for transmission to the surface to which therapy is being applied. The invention also includes a kit for at-home care of a region requiring therapy, in a manner that inhibits transmission of infectious agents.

Description

THERAPEUTIC COOLING PAD FOR OPHTHALMOLOGIC AND COSMETIC USE

CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 60/884,157, filed January 9.2007. and 60/973,828 filed September 20, 2007. which applications are incorporated herein by reference.

TECHNICAL FIELD

[0002] This invention relates a therapeutic patch for ophthalmologic and cosmetic use that provides therapy to the region where the patch is provided, specifically, the eye region; the therapeutic patch provides at least one therapeutic delivery layer, such as a hydrogel polymer, for placement against, for example, the eye region including, e.g., the peri-orbital tissues of a patient, and a non- contacting layer that can be used, for example, to generate cooling and / or moisture for transmission to the surface to which therapy is being applied. As contemplated by the invention, the patches can be pre-packaged in either sterile or non-sterile packing. The invention also includes a kit for at-home care of a region requiring therapy, in a manner that inhibits transmission of infectious agents.

BACKGROUND OF THE INVENTION

[0003] Eye patches are known in the art. For example, U.S. Patent 4,682, 371 discloses a protective eye patch. The '371 patch has several tabs for securing the patch to a patient's eye. U.S. Patent 3,068,863 discloses a patch designed to keep the eye closed. U.S. Patent 3,092,103 discloses a patch with a cushion material at the edge that allows the patient's eye to move underneath the eye patch. U.S. Patent 3,908,645 for an ophthalmic therapeutic pressure bandage with a conformable, permeable carrier tape.

[0004] Several conditions exist for which medical and cosmetic therapy is appropriate. For example, allergic conjunctivitis, post-traumatic or other edema and swelling, eye bags, and/or allergic blepharitis are common disorders of the eyes and adnexa that may cause itching, swelling, and discomfort in and around the eyes. Allergic symptoms include, itching, and foreign body sensation. Signs include redness, swelling, and ocular discharge. Ocular allergies are often seasonal and recurrent. There is no cure, and treatment is directed to control of symptoms. A cool wet compress is often applied to the eye region to aid in symptom control. Furthermore, swelling around the eye is regularly treated with a cool wet compress.

[0005] What is needed is a device that conveniently delivers cooling and moisture to at least one eye region, including the eyelids, and is held in place over one or both eyes with a biocompatible adhesive. Furthermore, this device, or an alternative embodiment of the device, can act as a platform for delivery of a number of therapeutic agents based on the type of treatment desired and the severity of the disease process, including for example, steroids, anti-wrinkle and anti-eye bag cosmetic formulations. Additionally, the device can provide a mechanism for easily determining when therapy is being delivered and when therapy is no longer being delivered.

SUMMARY OF THE INVENTION

[0006] An aspect of the invention is directed to a variably configurable patch for delivering therapy to an eye region comprising: a therapy delivery layer; an aperture for accessing the therapy layer; and an adhesive layer for adhering the patch to a surface wherein the patch has a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when deployed. The patch can be configured such that a plurality of therapy layers are provided. Additionally, the therapy delivery layers can further comprise a therapeutic substance, such as steroids that include prednisone, and anti-aging, anti- wrinkle and anti-eye bag formulations. A separate cooling layer can be provided to achieve a target temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C. Where there is a separate cooling layer, a non-permeable layer can be provided to separate all or part of the cooling layer from the therapy delivery layer. Alternatively, a permeable layer can be provided between the cooling layer and the therapy delivery layer. In some instances, an additional moisture delivery layer can be provided; alternatively an existing layer can function as a moisture delivery layer. Where a separate moisture delivery layer is provided, a non-permeable or permeable layer can be provided between all or part of the moisture delivery layer and the therapy delivery layer. In some instances, a further layer comprising a layer of non-irritating material with sterile or non-sterile water can be provided, or a layer of non-irritating material impregnated with a therapeutic substance can be provided. The patch can further comprise a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling or a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture.

[0007] Another aspect of the invention is directed to a pre-configured patch for delivering therapy to an eye comprising: a layer selected from the group consisting of a cooling layer, a moisture delivery layer, and a therapy delivery layer; a skin contacting layer; an adhesive layer covering a portion of the skin contacting layer; and an exterior layer wherein the patch has a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when deployed. The patch can be configured such that a plurality of therapy layers are provided. Additionally, the therapy delivery layers can further comprise a therapeutic substance, such as steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations. A separate cooling layer can be provided to achieve a target temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C. Where there is a separate cooling layer, a non-permeable layer can be provided to separate all or part of the cooling layer from the therapy delivery layer. Alternatively, a permeable layer can be provided between the cooling layer and the therapy delivery layer. In some instances, an additional moisture delivery layer can be provided; alternatively an existing layer can function as a moisture delivery layer. Where a separate moisture delivery layer is provided, a non-permeable or permeable layer can be provided between all or part of the moisture delivery layer and the therapy delivery layer. In some instances, a further layer comprising a layer of non- irritating material with sterile or non-sterile water can be provided, or a layer of non-irritating material impregnated with a therapeutic substance can be provided. The patch can further comprise a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling or a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture.

[0008] Yet another aspect of the invention is directed to a kit for providing ophthalmologic treatment to an eye region housed in a container comprising: an eye patch adapted to achieve a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when activated; a therapeutic layer for an eye patch; an adhesive layer for an eye patch; a therapeutic substance provided within a container. The kit can further comprise a therapy status indicator, such as an indicator that indicates the temperature of the therapy being delivered. The therapy status indicator can be configured such that it is protected from the ambient temperature. Additional indicators can be provided such as a therapy indicator, a therapy delivery timer, and the like. The kit can further comprise one or more therapeutic substances selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations. Each therapeutic substance can be provided for in its own container within the kit. [0009] In still another aspect of the invention, a kit for providing ophthalmologic treatment to an eye region housed in a container comprising: a first eye patch for cooling the eye region and delivering moisture to the eye region; and a second eye patch for delivering therapeutic substances to the eye region is provided. The kit can further comprise a therapy status indicator, such as an indicator that indicates the temperature of the therapy being delivered. The therapy status indicator can be configured such that it is protected from the ambient temperature. Additional indicators can be provided such as a therapy indicator, a therapy delivery timer, and the like. The kit can further comprise one or more therapeutic substances selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations. Each therapeutic substance can be provided for in its own container within the kit.

[0010] A kit for providing cosmetic treatment to an eye region housed in a container is also provided for. The kit comprises: a first eye patch for cooling the eye region and delivering moisture to the eye region; and a second eye patch for delivering cosmetically beneficial substances to the eye region. The kit can further comprise a therapy status indicator, such as an indicator that indicates the temperature of the therapy being delivered. The therapy status indicator can be configured such that it is protected from the ambient temperature. Additional indicators can be provided such as a therapy indicator, a therapy delivery timer, and the like. The kit can further comprise one or more therapeutic substances selected from the group consisting of: steroids that include prednisone, and anti-aging, anti- wrinkle and anti-eye bag formulations. Each therapeutic substance can be provided for in its own container within the kit.

[0011] In yet another aspect, a patch for delivering therapy to an eye region is provided for. The patch comprises a therapy delivery layer adapted to deliver therapy at a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when deployed; an adhesive layer for adhering the patch to a surface; and a therapy delivery indicator. The patch can be configured such that a plurality of therapy layers are provided. Additionally, the therapy delivery layers can further comprise a therapeutic substance, such as steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations. A separate cooling layer can be provided to achieve a target temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C. Where there is a separate cooling layer, a non-permeable layer can be provided to separate all or part of the cooling layer from the therapy delivery layer. Alternatively, a permeable layer can be provided between the cooling layer and the therapy delivery layer. In some instances, an additional moisture delivery layer can be provided; alternatively an existing layer can function as a moisture delivery layer. Where a separate moisture delivery layer is provided, a non-permeable or permeable layer can be provided between all or part of the moisture delivery layer and the therapy delivery layer. In some instances, a further layer comprising a layer of non-irritating material with sterile or non-sterile water can be provided, or a layer of non- irritating material impregnated with a therapeutic substance can be provided. The patch can further comprise a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling or a layer of non- irritating material impregnated with a therapeutic substance activated with the application of moisture. [0012] In still another aspect of the invention a pre-configured patch for delivering therapy to an eye is provided. The pre-configured eye-patch comprises: a layer selected from the group consisting of a cooling layer, a moisture delivery layer, and a therapy delivery layer; a skin contacting layer; an adhesive layer covering a portion of the skin contacting layer; an exterior layer; and a therapy delivery indicator wherein the patch has a temperature below body temperature of 37⁰C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when deployed. The patch can be configured such that a plurality of therapy layers are provided. Additionally, the therapy delivery layers can further comprise a therapeutic substance, such as steroids that include prednisone, and anti-aging, anti- wrinkle and anti-eye bag formulations. A separate cooling layer can be provided to achieve a target temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C. Where there is a separate cooling layer, a non-permeable layer can be provided to separate all or part of the cooling layer from the therapy delivery layer. Alternatively, a permeable layer can be provided between the cooling layer and the therapy delivery layer. In some instances, an additional moisture delivery layer can be provided; alternatively an existing layer can function as a moisture delivery layer. Where a separate moisture delivery layer is provided, a non- permeable or permeable layer can be provided between all or part of the moisture delivery layer and the therapy delivery layer. In some instances, a further layer comprising a layer of non-irritating material with sterile or non- sterile water can be provided, or a layer of non-irritating material impregnated with a therapeutic substance can be provided. The patch can further comprise a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling or a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture.

INCORPORATION BY REFERENCE

[0013] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0015] FlG. 1 is a top view of a patch according to the invention;

[0016] FlG.2 is a lower view of a patch according to the invention;

[0017] FlGS.3A-D are alternative cross-sectional views of the patch taken along the lines 3-3 in FlG. 1, wherein each figure illustrates an alternative embodiment;

[0018] FlG.4 is a block diagram showing the steps of making a patch;

[0019] FlG. 5 is a top view of a patch, according to the invention, contained in packaging.

[0020] FlG. 6 is a top view of a patch, according to the invention, further including a display capable of indicating delivery of therapeutic temperature range.

DETAILED DESCRIPTION OF THE INVENTION

[0021] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby. [0022] The following description is presented to enable any person skilled in the art to make and use the invention. Various modifications to the embodiments described will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the present invention as defined by the appended claims. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein.

[0023] FlG. 1 illustrates a top view of a patch 100 according to the invention. As illustrated, the patch 100 can take on a tear-drop shape. Alternatively, the exterior perimeter of the patch 100 can take on other shapes, such as circular, substantially circular, oval, or substantially oval. The shape can be optimized for use on either the right or left eye, or the shape can be optimized for use with either eye, periorbital or adnexal tissue, or both eyes simultaneously. The overall width (measured along the x axis) and height (measured along the y axis) of the patch 100 will vary depending on the size of the patient for which the patch is intended. As shown here, the upper surface of the patch 102, which is not in contact with the patient, can be selected from the following materials: cotton, synthetic fibers, and/or suitable lint-free material. As will be appreciated by those of skill in the art, depending upon the contents of the various layers of the patch, it may be desirable for the upper surface 102 to be flexible while remaining fairly impermeable.

[0024] FlG.2 illustrates a bottom view of a patch 100, showing the surface of the patch that is in contact with a patient's eyelid and periorbital skin, according to the invention. As illustrated, the patch 100 has a therapy delivery surface 120 and an adhesive edge 122 for adhering the patch to the skin surface of a patient. The adhesive can be formed of any suitable material that enables the patch 100 to adhere to the skin of the patient, including, for example, hypo -allergenic and latex free adhesive. Additionally, the adhesive edge can be incorporated into the therapy delivery surface and need not be a completely separate component.

[0025] As will be appreciated by those of skill in the art, the patch can be assembled in a variety of configurations to achieve the intended result. For example, the patch can be comprised of layers each of which is formed from a separate material wherein one or more of the layers have separate properties. Alternatively, the patch can be comprised of layers formed from one or more materials or substances which are adapted and configured to have varying properties. Thus, for example a delivery layer and an adhesive layer can be formed from a single layer of a target substance which has properties that facilitate delivery of cooling or therapy while also having properties that facilitate adhesiveness to the skin.

[0026] As shown in FlG. 3A, an upper surface 102 is provided which can provide a permeable or non-permeable seal for a delivery layer 104. The delivery layer 104 can be preformed to include, for example, water, and ammonium nitrate. Alternatively, the delivery layer 104 can be a moisture delivery layer or a cooling moisture delivery layer. In that event, the delivery layer 104, may be formed from two layers, one for generating cooling and one for delivering moisture. As will be appreciated by those of skill in the art, delivery layer 104 can, in turn be formed of a plurality of components or layers enabling delivery of more than one therapy to be achieved. The mechanism of cooling generation in layer 104 can be accomplished through several approaches. The cooling can be generated as a byproduct of an endothermic chemical reaction. Reactants can include various combinations of water and ammonium nitrate, sodium bicarbonate, citric acid, and barium hydroxide. Reactants such as these could be activated by exposure to water. Another approach could be an external pouch that is cooled via a freezer or refrigerator and inserted into layer 104. This pouch could be single or configured for multiple use. The amount of cooling provided will vary depending upon the application and therapeutic material to be delivered. Typically, cooling will result in the surface temperature of the area contacted being brought below the body temperature of 98.6°F (37°C). In most applications the patch will have a cooling temperature below 35°C, more preferably below 33°C, even more preferably below 30⁰C, and in some instances below 25°C.

[0027] Depending upon the contents of the delivery layer 104, a permeable or non-permeable layer 110 can be optionally provided or incorporated as a feature into an existing layer. Where the delivery layer 104 is a cooling layer, the optional layer 110 would most likely be non-permeable to the materials provided to generate cooling. In that instance, the optional layer 110 would be formed of, for example, a water resistant material such as cellophane. Where the delivery layer 104 is designed to deliver only moisture, the optional layer 110, if present, would most likely be permeable to allow the moisture to reach the eye. In that instance, the optional layer 110 would be formed of any suitable material including, for example, cotton.

[0028] Depending upon the intended therapeutic application of the patch 100, the therapy delivery layer 120 could comprise a variety of materials. For example, a layer of hypoallergenic and/or non-irritating material, such as for example cotton or hydrogel, with sterile or non-sterile water or saline could be provided; a layer of non- irritating material impregnated with a therapeutic substance could be provided; a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling could be provided; or a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture could be provided. The non-irritating material could be any suitable material that is sterile or non-sterile, such as gauze. The impregnating substance could be, for example, steroids, e.g. prednisone; anti-aging treatment formulations, e.g., Eyeliss by Sederma, used to prevent puffiness and reduce bags under the eye, Drmazyl by Sederma, used as an anti-aging wrinkle smoothing and cutaneous barrier repair, Sudden Change Eye Gel with Green Tea by Sudden Change, Sudden Change Under-Eye Firming Serum, by Sudden Change, Bio-Performance Super Eye Contour Cream, an anti-wrinkle and anti-dark circle formulation by Shiseido, to name a few.

[0029] As illustrated in FlGS. 3A-B the adhesive edge 122 can be configured such that it encircles a portion of the outer edge of the patch 100 (shown in FlG. 3 A). Alternatively, the adhesive layer 122 can be configured such that it forms a complete layer between the optional layer 110 and the delivery layer 120 (as shown in FlG. 3B). Additionally, the adhesive layer need not be a layer added to the device per se, but can be a quality of an existing layer such as might be achieved by using hydrogel. Suitable hydrogels include, for example, any gel, such as a colloidal gel, in which water is a dispersion medium.

[0030] In an alternative embodiment, shown in FlG. 3c, a receiving mechanism 140 is provided for filling the delivery layer 120. Such a mechanism is, for example, an aperture capable of enabling materials to be integrated into the layer 120. Ideally, the aperture would be sealable such that once the desired material is delivered to the therapeutic delivery layer 120, the aperture can be sealed to prevent ingress or egress of materials from the delivery layer 120. In this scenario, the delivery layer 120 could initially be dry and the user would inject, or otherwise permeate, the delivery layer 120 with the substance desired to come into contact with the skin surface. Alternatively, the layer could contain a fluid, such as water, or a catalyst for reacting with the materials delivered. Suitable substances are, for example, those listed above.

[0031] In an alternative embodiment, shown in FlG. 3D, a receiving mechanism 142 is provided for filling the delivery layer 104. Similar to the receiving mechanism 140 described above, a suitable mechanism is, for example, an aperture capable of receiving materials. In this scenario, the delivery layer 104 could be dry and the user would inject, or otherwise permeate, the delivery layer 104 with a substance capable of delivery cooling, moisture or both to the patch. Suitable substances are, for example, those listed above.

[0032] In the embodiments described above it is contemplated that the filled materials can be inserted in a manner whereby the materials do not come in contact with the patient's skin, e.g., some of the filled materials used for generating cooling and/or filled material that are not biocompatible. Additionally, it is contemplated that the patch 100 can be configured such that steam and/or cooling is delivered for a prescribed period of time followed by delivery of therapeutic material. In this instance a degradable layer could be provided such that delivery of steam or cooling degrades the layer of time such that the degraded layer allows for the delivery of therapeutic material. In this instance, the delivery of the therapeutic layer could occur some time after the beginning of delivering steam and/or cooling or some time after the conclusion of delivering steam and/or cooling. Persons of skill in the art would be familiar with materials suitable for achieving this objective.

A variety of hydrogels suitable for use in performing the invention would be known to those skilled in the art. By way of example, a hydrogel suitable for use in practicing the invention would include: Hydrogel composed of either natural or synthetic cross-linked polymers is suitable. The cross-linking can be accomplished via several approaches, including radiation or heat. Typically, the hydrogel has the following features: a) has adhesive properties in order to assist in maintaining contact with the skin but is removable, preferably removable without pain, b) is fragrance free, c) has a high water content greater than 70%, ideally closer to 90% as a mechanism of delivering moisture, d) can be produced with varying thinness between 0.5mm and 3mm, e) is produced in a sheet either on a continuous role or in a plastic tray, such as a PVC tray, f) can be formulated with a therapeutic compound contained within the polymer structure that is released during the application period to the skin and g) is sufficiently solidified as to maintain its basic shape, either with or without the addition of a reinforcing mesh.

Specific examples of suitable hydrogel include MaxGel hydrogel produced by Maxford Medical Technology, Co. Ltd. (Hong Kong), and Hydrogel Patch produced by Tyco-Kendall Healthcare (USA). Other hydrogel materials would be apparent to those skilled in the art. Some applications of and formulations for hydrogels include those disclosed in, for example, US20070190122 for Skin dressings; US20070173916 for Electrode with edge protection; US20070148117 for Skin dressings; US20070088419 for Conductive pad assembly for electrical therapy device; US20070083147 for Iontophoresis apparatus and method to deliver antibiotics to biological interfaces; US20070065385 for Cold production method for pearly lustre preparations containing alcohols; US20070055371 for External breast prosthesis; US20070043417 for Moisture resistant electrode with edge protection; US20070009582 for Composition useful as an adhesive and use of such a composition; US20060286152 for Fabric- supported chitosan modified temperature responsive PNIPAAm/PU hydrogel and the use thereof in preparation of facial mask; US20060275351 for Topical Oligopeptide Delivery System; US20060222622 for Methods and compositions for preventing and treating radiation-induced skin reactions; US20060200063 for Absorbent multilayer hydrogel wound dressings; US20060195024 for Laser diode optical transducer assembly for non-invasive spectrophotometric blood oxygenation; US20060182789 for Apparatus and method for transdermal delivery of epoetin-based agents; US20060148352 for Absorbent materials and articles; US20060116565 for Reverse current controlling electrode with oversize backing; US20060068014 for Ionic hydrogels with controlled aqueous fluid absorption; US20060029652 for Absorbent hydrogel compositions; US20060025521 for Polymerizing hydrogels including modifying compounds to comprise low amount of residual monomers and by-products and to optimize material properties; US20050287191 for Hydrogel composites; and US20050261643 for Closed wound drainage system.

[0033] Turning now to FlG. 4, a flow chart is provided that illustrates the process for determining the configuration of a patch 100. The first step is to assess the eye and peri-orbital adnexa and structures including the eye lids, eye lashes, conjunctiva, and tear film 400. A variety of conditions suitable for use of an eye patch of this invention includes, for example, allergic blepharitis, allergic conjunctivitis, post-traumatic swelling, post-surgical swelling, and non-traumatic swelling, and conditions of aging of the peri-orbital structures such as eyelid "bags" or puffiness. In assessing the eye 400, a practitioner will determine the amount, if any, and duration of any cooling to be applied 410 or steam to be applied 411. If cooling is to be applied, then a suitable cooling delivery mechanism or layer will be chosen 420. Alternatively, if moisture is to be applied then a suitable moisture delivery mechanism or layer will be chosen 421. As will be appreciated by those of skill in the art, theses steps can be skipped 422 without departing from the scope of the invention. Additionally, following the step of selecting a cooling layer 420 or steam layer 421 the assembled eye patch can be applied to the eye 450 (steps 424 or 426)

[0034] In another process, after the eye is assessed 400, a therapy layer can be selected 430, and then applied to the eye patch 440. The assembled patch can then be applied to the eye 450.

[0035] When it is determined that both cooling and therapy are required, the eye is assessed 400 as described above. The practitioner will then determine the amount and duration of cooling to be applied 410 and will select a suitable cooling delivery mechanism or layer 420. Thereafter, the practitioner can select a therapy layer 430 and apply the therapy layer to the eye patch 440. Once the eye patch has been configured, the assembled eye patch can then be applied to the eye 450. As will be appreciated by those of skill in the art, a practitioner can perform the process of selecting the therapy layer prior to selecting the cooling layer without departing from the scope of the invention. Additionally, the process of selecting the layer and assembling the patch can be performed by the practitioner, e.g., physician or nurse treating a patient, or can be performed in a factory, or using a suitable manufacturing process, such that the practitioner selects a pre-made eye patch containing the desired cooling layer and therapy layer and then applies the pre-assembled patch to the patient's eye. Alternatively, the process of selecting and assembling the patch can be performed by the patient. Additionally, whether selected by patient or practitioner, the patch can be self-applied by the patient.

[0036] FlG. 5 illustrates a patch 100 which has been preconfϊgured and placed into a package 150 for delivery to a patient. The package can be sterile or non-sterile in configuration. The patch can be adhered using the adhesive edge 122 to the interior of the package 150 or can be placed on a removable insert within the package. [0037] A variety of kits are contemplated with the invention. In a first kit, one or more patches 100 having the same therapeutic benefit can be provided, e.g. providing cooling to warm the moisture and baby shampoo that are in the therapy delivery layer and intended to be in contact with the peri-orbital surfaces. Alternatively, a kit can be provided that provides one or more patches 100 having more than one benefit: e.g., a first type of patch with a first function, such as providing cooling and moisture to the eye, and a second type of patch with a second function, such as providing additional therapy to the surface. Yet another kit contemplated includes a plurality of blank patches 100 which can be loaded with a variety of materials, as described above, to achieve the intended therapeutic benefit. [0038] Turning now to FlG. 6, an alternative embodiment of a therapeutic patch 100 of the invention is shown. In this embodiment, a therapy indicator 160 is provided. The therapy indicator can be, for example, a thermometer or decal with a temperature sensor that displays an indication of therapy status. Temperature sensing devices come in a variety of forms, and are known in the art. Temperature sensing devices include, for example, thermochromic liquid crystals (TLC), capable of changing colors in response to temperature. TLCs typically show color by selectively reflecting incident white light. The temperature sensitive mixtures in films then reflect colors as they turn from colorless (black against black background) to, for example, red at a given temperature or pass through other colors of the visible spectrum as the temperature decreases. See, for example, U.S. Patent 6,257,759. Where the patch 100 includes a therapy indicator 160, it is contemplated that the therapy indicator is adhered in a manner that protects the therapy indicator from ambient temperature and results in the indicator 160 providing an indication of the temperature of the therapy being delivered or the status of the therapy being delivered. The indicator 160 can, for example, provide a display that indicates the temperature, in either Celsius or Fahrenheit, of the therapy being delivered, or can indicate to the user the status of the patch in a "go-no go" fashion. If the go-no go indication is used, then the use of iconography, such as a "thumbs up" sign when the temperature is in the therapeutic range, and/or an "X" can be used to indicate that the therapy delivery cycle has completed (to accommodate non-English speaking patients), or the use of appropriate words, for example: Done, Fin, etc.

[0039] It is also contemplated that the therapy delivery indicator could function as a therapy delivery timer. In that instance, the indicator would indicate completion of therapy at the end of a prescribed period of time. [0040] The foregoing description of embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to the practitioner skilled in the art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention and the various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and its equivalence.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A variably configurable patch for delivering therapy to an eye region comprising a. a therapy delivery layer; b. an aperture for accessing the therapy layer; and c. an adhesive layer for adhering the patch to a surface. wherein the patch has a temperature below body temperature of 37°C, and optimally below room temperature of 26⁰C, but above freezing of 0⁰C when deployed.

2. The patch of claim 1 wherein a plurality of therapy delivery layers are provided.

3. The patch of claim 1 further comprising a therapeutic substance within the therapy delivery layer.

4. The patch of claim 3 wherein the therapeutic substance is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations.

5. The patch of claim 1 further comprising a cooling layer.

6. The patch of claim 5 wherein a non-permeable layer separates the cooling layer from the therapy delivery layer.

7. The patch of claim 5 wherein a permeable layer separates the cooling layer from the therapy delivery layer.

8. The patch of claim 1 further comprising a moisture delivery layer.

9. The patch of claim 8 wherein a non-permeable layer separates the moisture delivery layer from the therapy delivery layer.

10. The patch of claim 8 wherein a permeable layer separates the moisture delivery layer from the therapy delivery layer.

11. The patch of claim 5 further comprising a moisture delivery layer.

12. The patch of claim 11 wherein a non-permeable layer separates the moisture delivery layer from the therapy delivery layer.

13. The patch of claim 11 wherein a permeable layer separates the moisture delivery layer from the therapy delivery layer.

14. The patch of claim 1 further comprising a layer of non- irritating material with sterile or non-sterile water.

15. The patch of claim 1 further comprising a layer of non-irritating material impregnated with a therapeutic substance.

16. The patch of claim 1 further comprising a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling.

17. The patch of claim 1 further comprising a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture.

18. The patch of claim 1 further comprising a combined therapy delivery layer and moisture delivery layer of hydrogel.

19. A pre-confϊgured patch for delivering therapy to an eye comprising: a layer selected from the group consisting of a cooling layer, a moisture delivery layer, and a therapy delivery layer; a skin contacting layer; an adhesive layer covering a portion of the skin contacting layer; and an exterior layer wherein the patch has a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when deployed.

20 A pre-configured patch according to claim 19 wherein a second layer is selected from the group consisting of a cooling layer, a moisture delivery layer, and a therapy delivery layer

21 The patch of claim 19 wherein a plurality of therapy delivery layers are provided

22 The patch of claim 19 further comprising a therapeutic substance withm the therapy delivery layer

23 The patch of claim 22 wherein the therapeutic substance is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations

24 The patch of claim 19 further comprising a cooling layer

25 The patch of claim 24 wherein a non-permeable layer separates the cooling layer from the therapy delivery layer

26 The patch of claim 25 wherein a permeable layer separates the cooling layer from the therapy delivery layer

27 The patch of claim 25 further comprising a moisture delivery layer.

28 The patch of claim 27 wherein a non-permeable layer separates the moisture delivery layer from the therapy delivery layer

29 The patch of claim 27 wherein a permeable layer separates the moisture delivery layer from the therapy delivery layer

30 The patch of claim 24 further comprising a moisture delivery layer.

31 The patch of claim 20 wherein a non-permeable layer separates the moisture delivery layer from the therapy delivery layer

32 The patch of claim 20 wherein a permeable layer separates the moisture delivery layer from the therapy delivery layer

33 The patch of claim 19 further comprising a layer of non-irritating material with sterile or non- steπle water

34 The patch of claim 19 further comprising a layer of non-irritating material impregnated with a therapeutic substance

35 The patch of claim 19 further comprising a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling

36 The patch of claim 19 further comprising a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture.

37 The patch of claim 19 further comprising a therapy status indicator.

38 The patch of claim 37 wherein the therapy status indicator is configured to indicate the temperature of the therapy being delivered

39. The patch of claim 37 wherein the therapy status indicator is configured to be protected from the ambient temperature

40 The patch of claim 19 further comprising a therapy delivery timer

41 A kit for providing ophthalmologic treatment to an eye region housed in a container comprising a an eye patch adapted to achieve a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when actived, b a therapeutic layer for an eye patch, c. an adhesive layer for an eye patch; d. a therapeutic substance provided within a container.

42. The kit of claim 41 further comprising a therapy status indicator.

43. The kit of claim 41 wherein the therapy status indicator is configured to indicate the temperature of the therapy being delivered.

44. The kit of claim 41 wherein the therapy status indicator is configured to be protected from the ambient temperature.

45. The kit of claim 41 further comprising a therapy indicator.

46. The kit of claim 41 further comprising a therapy delivery timer.

47. The kit of claim 41 further comprising one or more therapeutic substances is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations

48. A kit for providing ophthalmologic treatment to an eye region housed in a container comprising: a. a first eye patch for cooling the eye region and delivering moisture to the eye region; and b. a second eye patch for delivering therapeutic substances to the eye region.

49. The kit of claim 48 further comprising a therapy status indicator.

50. The kit of claim 49 wherein the therapy status indicator is configured to indicate the temperature of the therapy being delivered.

51. The kit of claim 49 wherein the therapy status indicator is configured to be protected from the ambient temperature.

52. The kit of claim 48 further comprising a therapy indicator.

53. The kit of claim 48 further comprising a therapy delivery timer.

54. The kit of claim 48 further comprising one or more therapeutic substances is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations

55. A kit for providing cosmetic treatment to an eye region housed in a container comprising: a. a first eye patch for cooling the eye region and delivering moisture to the eye region; and b. a second eye patch for delivering cosmetically beneficial substances to the eye region.

56. The kit of claim 55 further comprising a therapy status indicator.

57. The patch of claim 56 wherein the therapy status indicator is configured to indicate the temperature of the therapy being delivered.

58. The patch of claim 56 wherein the therapy status indicator is configured to be protected from the ambient temperature.

59. The kit of claim 55 further comprising a therapy indicator.

60. The kit of claim 55 further comprising a therapy delivery timer.

61. The kit of claim 55 further comprising one or more therapeutic substances is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti- wrinkle and anti-eye bag formulations

62. A patch for delivering therapy to an eye region comprising a. a therapy delivery layer adapted to deliver therapy at a temperature below body temperature of 37⁰C, and optimally below room temperature of 26⁰C, but above freezing of 0⁰C when deployed; b. an adhesive layer for adhering the patch to a surface; and c. a therapy delivery indicator.

63. The patch of claim 59 wherein a plurality of therapy delivery layers are provided.

64. The patch of claim 59 further comprising a therapeutic substance within the therapy delivery layer.

65. The patch of claim 61 wherein the therapeutic substance is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations.

66. The patch of claim 59 further comprising a cooling layer.

67. The patch of claim 63 wherein a non-permeable layer separates the cooling layer from the therapy delivery layer.

68. The patch of claim 63 wherein a permeable layer separates the cooling layer from the therapy delivery layer.

69. The patch of claim 63 further comprising a moisture delivery layer.

70. The patch of claim 66 wherein a non-permeable layer separates the moisture delivery layer from the

71. A pre-configured patch for delivering therapy to an eye comprising: a layer selected from the group consisting of a cooling layer, a moisture delivery layer, and a therapy delivery layer; a skin contacting layer; an adhesive layer covering a portion of the skin contacting layer; an exterior layer; and a therapy delivery indicator wherein the patch has a temperature below body temperature of 37°C, and optimally below room temperature of 26°C, but above freezing of 0⁰C when deployed.

72. The patch of claim 68 wherein a plurality of therapy delivery layers are provided.

73. The patch of claim 68 further comprising a therapeutic substance within the therapy delivery layer.

74. The patch of claim 70 wherein the therapeutic substance is selected from the group consisting of: steroids that include prednisone, and anti-aging, anti-wrinkle and anti-eye bag formulations.

75. The patch of claim 68 further comprising a cooling layer.

76. The patch of claim 72 wherein a non-permeable layer separates the cooling layer from the therapy delivery layer.

77. The patch of claim 72 wherein a permeable layer separates the cooling layer from the therapy delivery layer.

78. The patch of claim 68 further comprising a moisture delivery layer.

79. The patch of claim 75 wherein a non-permeable layer separates the moisture delivery layer from the therapy delivery layer.

80. The patch of claim 75 wherein a permeable layer separates the moisture delivery layer from the therapy delivery layer.

81. The patch of claim 72 further comprising a moisture delivery layer.

82. The patch of claim 68 wherein a non-permeable layer separates the moisture delivery layer from the therapy delivery layer.

83. The patch of claim 78 wherein a permeable layer separates the moisture delivery layer from the therapy delivery layer.

84. The patch of claim 68 further comprising a layer of non-irritating material with sterile or non- sterile water.

85. The patch of claim 68 further comprising a layer of non- irritating material impregnated with a therapeutic substance.

86. The patch of claim 68 further comprising a layer of non-irritating material impregnated with a therapeutic substance activated with the application of cooling.

87. The patch of claim 68 further comprising a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture.