Temperature and Visibility Regulated Therapy Device

Abstract

A topical temperature therapy device that imparts known temperatures as a function of time to the therapy skin surface of a user during the course of therapy. The skin surface can be intact or breached through injury or surgery. The therapy temperature and time profile can be varied by varying the selections of, among several parameters, the formulation of the heat exchange material and the material and dimensions of the heat exchange material container, thus meeting the needs of a wide range of injuries and demographics. The therapy device contains a temperature indicator indicating the temperature of the heat exchange material in real time. The therapy device further provides visibility to the therapy skin surface during the course of the therapy to allow visual inspection of the therapy area as means to improve therapeutic outcomes. The therapy device is flexible and conforms to the anatomy of the therapy area.

Claims

1. A topical temperature therapy device for providing cold and warm temperatures to perform a therapeutic function to a skin surface requiring therapy on a user, comprising: a heat exchange material; and a heat exchange material container, and wherein the heat exchange material container encapsulates and encloses the heat exchange material to form the therapy device, and together have sufficient visible light transmission (VLT) to permit visual inspection of the therapy skin surface, through the therapy device, during the course of therapy.

2. The therapy device according to claim 1, having a VLT value between 60% and 100% for a majority of a surface area of the therapy device throughout the entire device and throughout the duration of a therapy.

3. The therapy device according to claim 1, wherein the heat exchange material is a liquid at room temperature possessing a freezing temperature at 18 C. or below;

4. The therapy device of claim 3, wherein the heat exchange material is water containing at least one or more of the following: an electrolyte, a salt, a water-soluble polymer, or a heat transfer material comprising a class of phase change material (PCM) where PCM is a class of material capable of maintaining a narrow melting temperature range at the selected temperature range.

5. The therapy device of claim 3, wherein the heat exchange material is a water and glycerin mixture with glycerin constituting from 35% to 75% by volume, or a water and propylene glycol mixture with propylene glycol constituting from 35% to 65% by volume.

6. The therapy device of claim 5, wherein the heat exchange material contains an additive such as a rheology modifier, a stabilizer, a defoamer or a colorant.

7. The therapy device of claim 1, wherein the heat exchange material container is made of a clear flexible polymeric material.

8. The therapy device of claim 7, wherein the polymeric material is selected from one of a plastic, a thermoplastic, an elastomer, a rubber, or a polymer blend.

9. The therapy device of claim 7, wherein the flexible heat exchange material container is a clear flexible polyurethane or a clear flexible polyvinylchloride.

10. The therapy device of claim 8, wherein the heat exchange material container comprises a wall member that imparts a height to the therapy device, the wall fabricated prior to the container being filled with the liquid heat exchange material.

11. The therapy device of claim 9, wherein the heat exchange material container comprises a wall member that imparts a height to the therapy device, the wall fabricated prior to the container being filled with the liquid heat exchange material.

12. The therapy device of claim 1, wherein the heat exchange material container is made of a clear rigid polymeric material.

13. The therapy device of claim 12, wherein the rigid heat exchange material container is selected from one of a plastic, a thermoplastic, an elastomer, a rubber, or a polymer blend.

14. The therapy device of claim 7, wherein the surface of the flexible heat exchange material container on the therapy skin side has a thickness between 0.2 mm and 2.0 mm.

15. The therapy device of claim 1, wherein the heat exchange material container comprises one single compartment, or two compartments or more than two compartments, each divided by a wall with the neighboring compartment to allow either no liquid exchange between compartments, or a controlled amount of liquid exchange between compartments.

16. The therapy device of claim 1, wherein the heat exchange material container contains one or more floating labels floating in the midst of the heat exchange material serving functional, informational or decorative purposes.

17. The therapy device of claim 16, wherein the floating label is a temperature indicator indicating temperature of the heat exchange material in real time during the course of cold or warm therapy.

18. The therapy device of claim 1, wherein when in contact with human skin, configured to deliver cold therapeutic temperatures 6 C. to 12 C. to the therapy skin surface within the first 5-10 minutes of contact, maintain a skin surface temperatures between 7 C. to 12 C. for 10-15 minutes before reaching a skin surface temperature range of 12 C. to 15 C. at 30 minutes after contact.

19. The therapy device of claim 1, wherein when in contact with human skin, configured to deliver a warm therapeutic temperature within a range of 37 C. to 42 C. for a duration of 30 minutes.

20. A method of applying the temperature therapy device of claim 1, to a user's skin surface, comprising: contacting the topical temperature therapy device to the skin surface; imparting a therapeutic temperature as a function of time to the skin surface under therapy; viewing the therapy skin surface through the therapy device during the course of therapy, wherein the device has a VLT value between 60% and 100% through a majority of the device; viewing a temperature indicator inside the therapy device and within a line of sight between the therapy device and the skin. delivering cold therapeutic temperature of 6 C. to 12 C. to the therapy skin surface within the first 5-10 minutes of contact of the therapy device to the skin; and maintaining a skin surface temperatures between 7 C. to 12 C. for 10-15 minutes before reaching a skin surface temperature range of 12 C. to 15 C. at 30 minutes after contact. delivering a warm therapeutic temperature within a range of 37 C. to 42 C. for a duration of 30 minutes, while contacting the skin with the therapy device.

21. A method of constructing a temperature therapy device of claim 1, for providing cold and warm temperatures to perform a therapeutic function to a skin surface requiring therapy on a user, wherein: providing cold temperatures comprises: delivering cold therapeutic temperatures of 6 C. to 12 C. to the skin surface within the first 5-10 minutes of contact of the therapy device to the skin; and maintaining a skin surface temperatures between 7 C. to 12 C. for 10-15 minutes before reaching a skin surface temperature range of 12 C. to 15 C. at 30 minutes after contact; providing warm temperatures comprises delivering warm therapeutic temperatures within a range of 37 C. to 42 C. for a duration of 30 minutes, while contacting the skin with the therapy device; the method comprises: selecting a heat exchange material; selecting a polymeric material for a heat exchange material container to encapsulate and enclose the heat exchange material to form the therapy device; selecting a height of the heat exchange material container; selecting an interface thickness; wherein the selected heat exchange material and heat exchange material container together have a VLT value between 60% and 100% for a majority of a surface area of the therapy device throughout the entire device and throughout the duration of a therapy; assembling the heat exchange material and heat exchange material container having a height, with a temperature indicator within the heat exchange material and visible from the outside of the container; wherein the selected heat exchange material, heat exchange material container, height, and interface thickness together provide either a cold therapeutic temperature or a warm therapeutic temperature as a function of time based on the selected heat exchange material, heat exchange material container, height, and interface thickness.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The accompanying drawings, which are incorporated herein and form part of the specification, illustrate various embodiments of the present invention and together with the description, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. In the drawings, like reference numbers indicate identical or functionally similar elements. A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

[0049] FIG. 1 is the cross-sectional view of an exemplary embodiment of a transparent temperature therapy device. FIG. 1A is a flexible transparent therapy device and FIG. 1B a rigid transparent therapy device.

[0050] FIG. 2 is an exemplary embodiment of a flexible transparent temperature therapy device applied to the therapy skin surface, with or without a lesion.

[0051] FIG. 3 is an exemplary embodiment of a flexible transparent temperature therapy device. FIG. 3A is the two-parts of a HEM container prior to filling with the HEM and sealing.

[0052] FIGS. 3B and 3C demonstrate the full range of flexibility of the exemplary embodiment therapy device.

[0053] FIG. 4 is an exemplary embodiment of a flexible transparent temperature therapy device fully transparent at low temperatures, as indicated by both an external digital thermometer and a thermometer embedded to float in the HEM compartment. FIG. 4A demonstrates therapy device visibility at a low temperature shortly after removal from a freezer. FIG. 4B demonstrates therapy device visibility at a higher temperature as the therapy device warms up in the ambient condition.

[0054] FIG. 5 is an exemplary embodiment of a flexible transparent temperature therapy device at an ambient temperature demonstrating full visibility. FIG. 5A is without floating labels and FIG. 5B with floating labels.

[0055] FIG. 6 is a skin surface temperature-time profile upon placing an exemplary flexible transparent therapy device on the skin surface of a healthy adult to perform cold therapy. The curves in FIG. 6 represent different HEM formulations and different chill conditioning for cold therapy.

[0056] FIG. 7 is a skin surface temperature-time profile upon placing an exemplary rigid transparent therapy device on the skin surface of a healthy adult to perform cold therapy.

[0057] FIG. 8 is a skin surface temperature-time profile upon placing an exemplary flexible transparent therapy device on the skin surface of a healthy adult to perform heat therapy.

DETAILED DESCRIPTION OF THE DRAWINGS

[0058] In the following detailed description, reference is made to the accompanying drawings which form a part hereof and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural or logical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

[0059] By therapy device is meant a device to provide temperature therapy that consists of a heat exchange material, HEM and a HEM container containing the HEM within.

[0060] By therapy skin surface is meant the skin surface where the therapy device is applied to perform therapy. The therapy skin surface can be an intact skin surface or a breached skin surface. An intact skin surface can be a skin surface of muscle strains, sprains, discomfort, pain, bruises or the like. A breached skin surface can be a lesion or a laceration resulting from one or more types of trauma, injury, burn, surgery or medical intervention.

[0061] By user is meant a person, either with a medical condition that requires cold/hot therapy, or without a medical condition using the therapy device just to relieve general pain and improve comfort. A user can be a medical patient under the care of a medical professional or a physical therapist or the like. A user can be a medical patient in a conscious state or a medical patient under sedation. A user can be an infant or a toddler without fully developed sensory function or verbal skills and under the care of an adult. In some cases, a user can be an animal where the temperature therapy device is deemed necessary by its owner.

[0062] By care-giver is meant a person providing care to the user in therapy. For example, a care-giver can be an adult caring for a child in need of a temperature therapy. For example, a care-giver can be a medical professional in a hospital, clinic or a physical therapy facility providing care to a medical patient.

[0063] By hot therapy is meant a warmer than the body core temperature which is provided to the skin surface to perform a therapeutic function. The hot therapy is also termed warm temperature or warm therapy because the temperatures in this therapy imparting on the skin surface is not to cause burn to the skins, and some would describe these temperatures as warm.

[0064] By Heat Exchange Material, HEM is meant a heat-transfer material with certain heat capacity and it exchanges heat with a body when the therapy device is in contact with the therapy skin surface. A HEM is enclosed in a HEM container and pre-conditioned according to the therapeutic need. The HEM is termed coolant when describing a cold therapy device.

[0065] By HEM container is meant a container that contains HEM and isolates HEM from the environment. The HEM container can be made of a flexible polymeric film. The HEM container can also be made of a rigid polymeric material.

[0066] By interface is meant the surface of the HEM container that comes in contact with the therapy skin surface of a user. Interface is an integral part of the HEM container and serves to perform heat exchange between the HEM and the therapy skin surface during the course of therapy.

[0067] By compartment is mean that the entire cooling device is divided into various compartments with walls between neighboring compartments.

[0068] By Phase Changing Material, PCM is meant a material that melts or solidifies at a narrow temperature range and is capable of storing and releasing a large amount of energy upon phase change.

[0069] By Visible Light Transmission, VLT is meant the amount of light in the visible spectrum that passes through the therapy device.

[0070] By swimming labels or floating labels is meant one or more decals made of plastics or other materials may be placed in the midst of HEM and inside the HEM compartment, and these labels can move around (swim) in the HEM. Depending on the density differences between the swimming labels and the HEM, the swimming labels may be floating to the top of the HEM, or in the middle or towards the bottom of the HEM. In all cases, the swimming labels are not fixed and movable within HEM.

[0071] By mm is meant millimeter, cm centimeter, ml milliliter, L liter, C. temperature in degree Centigrade and F. temperature in degree Fahrenheit.

[0072] By compartment height is meant the compartment wall height, or the height of the HEM container. In other words, it is the distance between the top surface of the interface facing the HEM side and the bottom surface of the top cover of the container.

[0073] In an exemplary embodiment of FIG. 1A, 100 is the cross-sectional view of a transparent flexible therapy device. The cooling device 100 consists of a heat exchange material HEM 101 and a HEM Container 102. Container 102 has three compartments denoted by 103. Compartment 103 can be fabricated from a flat flexible film by one or more plastic fabrication methods such as vacuum forming, thermal forming, blister forming and the like. The Container has an interface 104 to be in direct contact with the therapy skin surface during therapy and a top cover 105 to seal the Container 102 after the Container 102 is filled with HEM 101. Interface 104 has a thickness of 106 and the top cover 105 has a thickness of 107. Compartment 103 has a height 108. Three compartments are divided by pre-formed partitioning walls 109 and the tip of the walls is sealed to the top surface 105 at the sealing point 110. Similarly, FIG. 1B is an exemplary embodiment of a single compartment transparent rigid therapy device. FIG. 1B has the same numeric notation designations except starting with 2.

[0074] The exemplary embodiments in FIG. 1 can be applied to a therapy skin surface to perform therapeutic function. FIG. 2 is an exemplary embodiment of FIG. 1A as applied directly to the therapy skin surface to perform therapy. The interface 104 of the therapy device 100 is in direct contact with the therapy skin surface 300 of skin layer 301, which may or may not have a lesion 302. FIG. 2 also represents that a compression pressure 350 may be applied on the top surface 105 of the therapy device 100 in the direction substantially vertical to the therapy skin surface 300. Similar inferences can be made when a rigid transparent therapy device 200 in FIG. 1B is applied to a therapy skin surface with or without a lesion, and applied in the presence or absence of a compression pressure.

[0075] The materials used in the therapy device in FIG. 1 is a polymeric material. The polymeric material in the fabricated form in container (102 and 202) can be flexible or rigid depending on the fabrication method to meet application requirements. The polymeric materials can be the classes of a plastic, a thermoplastic, an elastomer, a rubber or a polymer blend including but not limited to polyester, nylon, polyacrylamide, polycrylonitrile-polyacrylamide, polycarbonate, polystyrene, polyvinylchloride, low-density polyethylene, high density polyethylene, polypropylene, polyurethane, polyvinylchloride, polyvinyl alcohol, ABS, neoprene, nylon, polyethylene terephthalate, polyethylene glycol, poly-vinyl-pyrrolidone and methacrylates, ethylene vinyl acetate, polytetrafluoroethylene, expanded polytetrafluoroethylene, fluorinated polymer, fluorinated elastomer, cellulose, polyolefin, silicon-containing polymer, polysilicone, a mixture of the aforementioned, or the like.

[0076] The polymeric fabrication methods include but not limited to thermal forming, vacuum forming, blister forming, injection molding and the like. For example, the HEM Container 102 in the flexible transparent therapy device 100 in FIG. 1A and FIG. 2 can be fabricated from a pre-formed flexible clear polymeric films with a designated thickness, and the clear flexible polymeric film can be polyurethane or polyvinylchloride and the like. The flexible polymeric film is then thermal-formed or thermal-vacuumed formed into the lower half of Container 102, that is, the Container 102 without the top cover 105. This fabrication process also creates partition walls 109 into 3 compartments 103. After fabrication, liquid HEM is added to fill the compartments. After liquid HEM is filled, top cover is applied to seal the Container. The sealing can be any plastic welding process such as heat seal, radio-frequency seal, sonic welding . . . and the like, or sealed with a chemical adhesive.

[0077] Another example is that the HEM Container 202 in the rigid transparent therapy device 200 in FIG. 1B can be fabricated via a conventional injection molding method, and the injection molded parts are sonically sealed to join all parts. After liquid HEM is filled, the filling holes are sealed. Even though the manufacturing operations are different for both the flexible and the rigid therapy devices, their designs are derived from the same concepts and they serve the same functions to provide same benefits.

[0078] The dimension, shape and size of exemplary therapy devices in FIGS. 1A and 1B can be as varied as the types of injury and the range of user's demographics, except for the limitations in the Interface thickness (106 in FIG. 1A and 206 in FIG. 2B) as the Interface plays a key role in the heat exchange process between the HEM and the therapy skin surface, and regulates the therapy temperature impacting the therapy skin surface. In the flexible therapy device, the thickness of the Interface 106 is between 0.2 mm to 2.0 mm, and Interface 206 in a rigid therapy device between greater than 0.7 mm. The thicknesses of the top layers 105 and 205 and the walls 109 and 209 can be of any values depending on other design and functional requirements such as preventing heat (or cold) loss to the ambient during therapy time.

[0079] The heat exchange material HEM in FIGS. 1A, 1B and 2 can be selected from the materials described in the preceding paragraphs in the section on Summary of the Invention. The HEM is preferably in liquid form taking advantage of its transparency and flexibility. The HEM may contain minor amounts of additives such as a thickening agent, a pH adjusting agent, a defoamer, an inhibitor, a tinting colorant . . . and the like. The additives are to serve various functions. For example, a thickener is to improve the flow properties of the HEM by adjusting its viscosity. The thickener or a rheology modifier can be a natural gum polymer, polyacrylic acid, polyacrylate, a cellulosic or a cellulose derivative such as Carbomer 940 or Acusol 830. For example, a defoamer is added to improve the aesthetic appearance of the HEM in a transparent environment by removing bubbles. For example, an inhibitor is added to improve HEM shelf-life and stability. For example, a tinting colorant is added to improve the aesthetic appearance of the therapy device. The addition of the additives does not alter the heat capacity of the HEM and does not compromise the visibility requirement of the therapy device.

[0080] The selection criteria for the HEM are several. First, HEM should retain its fluidity at temperatures 18 C. or below. In other words, the selected HEM has a freezing temperature below 18 C. so that when storing in a household freezer, or a similar chilling device in a medical facility, the HEM remains flexible and fluid, for cold therapy use. In the case of a phase change material (PCM) is used, the freezing temperature is elected to be below 18 C.

[0081] Another criterion for the selection of HEM is that the selected HEM should have the heat capacity, at a given volume and surface contact area, to generate the cooling and heating temperature-time profile when working in conjunction with the selected Interface material and thickness. Finally, the selected HEM when enclosed in a particular design of a flexible or a rigid Container (102 and 202 in FIGS. 1A and 1B), the combined optical path should be such that the Visible Light Transmission VLT is between 60% and 100% to allow the observation of the therapy skin surface during the course of therapy.

[0082] The exemplary embodiments of the therapy device in FIGS. 1A, 1B and 2 may be used in conjunction with a compression force. The exemplary embodiments of the therapy devices in FIGS. 1A, 1B and 2 may be passively powered by pre-conditioning in a household freezer or a chilling device in professional medical facility for cold therapy use. The exemplary embodiments of the therapy devices in FIGS. 1A, 1B and 2 may be passively powered by immersing in the hot water bath or heated in a microwave oven for hot therapy use. The exemplary embodiments of the therapy devices in FIGS. 1A, 1B and 2 may be powered by a battery or by an external AC source to provide cold or hot therapy.

[0083] FIG. 3 is a 3-dimensional drawing and rendering of an exemplary embodiment of the flexible transparent therapy device. FIG. 3A demonstrates both parts of the therapy device 400, top part 401 containing top surface 402 and bottom part 403 containing three compartments 404. Therapy device 400 is pre-filled with HEM and pre-sealed Container. The compartment 404 has partition walls 405 and a height of 406. The Interface 407 is the surface on the bottom part 405 which is in contact with the therapy skin surface and not visible in this drawing. FIGS. 3B and 3C are 3-D solid rendering of FIG. 3A demonstrating the full range of flexibility of the exemplary therapy device.

[0084] FIG. 4 are photographic representations of an example flexible transparent therapy device 500 at low temperatures. In FIG. 4A, the therapy device 500, consisting of HEM 501 and HEM Container 502, is placed against a flat surface at an ambient condition shortly after taken out of a freezer. A digital thermometer 510 with a small thermocouple probe 511 is placed next to the therapy device 500. The digital thermometer 510 is placed underneath the therapy device 500 against a flat surface. One of the compartment in FIG. 4 contains a color-indicated liquid crystal thermometer strip 512 floating and swimming in liquid HEM 501. The 512 liquid crystal thermometer color indicates between 5 C.-10 C. consistent with the digital thermometer 510 reading of 7.3 C. As the therapy device in FIG. 4A warms up in the ambient conditions, FIG. 4B shows that the 512 liquid crystal thermometer color indicates between 15 C.-20 C., again consistent with the digital thermometer 510 reading of 16.0 C. Both FIGS. 4A and 4B also demonstrate the transparency and visibility of the therapy device. The thermocouple probe 511 under the therapy device and the thermometer 512 inside the therapy device are clearly visible at all times.

[0085] FIG. 5 are photographic representations of an example flexible transparent therapy device at the ambient conditions, again demonstrating transparency and visibility of the therapy device. The therapy device may contain nothing inside as shown in FIG. 5A, or may contain a thermometer 600 and other decorative decals 601 inside HEM Compartment 602 and floating and swimming inside HEM 603. Other informational, functional or decorative decals may be placed in the therapy device in the same manner.

[0086] FIGS. 4 and 5 demonstrate a rectangular shaped flexible therapy device with 3 compartments at the approximate width of 15 cm and length 25 cm. It is to be emphasized that the therapy device can be made of any desired shape and size. For example without limitation, rectangular, rectangular with rounded corners, round, oval, oval with different axis ratios, triangular, triangular with rounded corners, hexagon, hexagon with rounded corners, octagon with rounded corners . . . and the like. The shape of the flexible therapy device can also be of an irregular shape, for example without limitation, the shape of an animal, the shape of a flower, the shape of an object . . . and the like. The size of the flexible therapy device can be as small as to provide therapy to a very small surface area, such as a human finger, but can be as large as to provide therapy to the bigger anatomical locations such as the entire back or the thigh of a user. The therapy device can be of one single compartment, two-compartments or more than two compartments. In the multiple compartment design, the compartments can be of equal size and same shape, but also can be of different sizes and different shapes.

[0087] The floating labels placed inside the HEM compartment in the midst of HEM as shown in FIG. 5B can serve a particular function or just for decorative purposes. For example without limitation, floating labels can be a thermometer indicating the coolant temperature, a company logo, a user's instruction or a storage information . . . and the like. For example, the swimming labels can be decorative for aesthetic and promotional purposes. For example, a flower, an animal, a cartoon character . . . and the like. The floating labels can be made of a rigid or a flexible polymeric film of a variety of thickness and a wide variety of color and designs. The floating labels can be produced by the silk screen process or by some other similar production methods. The image-printed plastic label can be either use as is, or laminated with thin clear gloss film for protection purposes.

[0088] FIG. 6 is an exemplary therapy skin surface temperature of a healthy adult as a function of time upon placement of a pre-cooled transparent flexible therapy device directly on the therapy skin surface. The HEM formulation in Curve 1A is different from that in Curves 2A and 2B, while Curves 2A and 2B are of the same HEM formulation. The difference in the two formulations in FIG. 6 is the different ratios of glycerol and water, and both with a minor amount of additives. The transparent flexible film used in FIG. 6 data is a clear flexible polyvinylchloride at the same thickness of 0.4 mm. The flexible film has the cold crack rating at 40 F. All three curves represent therapy devices with the same interface material and thickness.

[0089] Formulation in Curve 1A showed that, at 5 minutes, the therapeutic temperature reaches 8 C. (47 F.) while formulation in Curve 2A reaches 10 C. (50 F.), both in the effective therapy temperature range. The lowest temperatures for Curve 1A and Curve 2A are 7 C. (45 F.) and 9 C. (48 F.) respectively and at approximately 8-10 minutes time. Both formulations maintain at the lowest temperature range for approximately 3-5 minutes before the temperature starts to gradually rise, and rising in a manner consistent with the warming requirement after the cold therapy. At the end of the recommended therapy time of 30 minutes, the therapy skin temperature is warmed up to between 12.5 C. (or 55 F.) and 14.5 C. (or 58 F.), respectively. Skin temperature range between 12.5 C.-15 C. (or 55 F.-58 F.) is considered comfortable cool temperatures, but not the cold temperature that has the potential to cause ice burn. At this time, the therapy device may be removed from the therapy skin surface, or the therapy may continue at warmer temperatures if deemed acceptable by the user or the care-giver. The warming process continues in a gradual gentle manner until reaching the ambient temperature at approximately 1 hour or longer.

[0090] Alternatively, the therapy device may be placed in a household refrigerator, instead of a freezer, to produce a gentler and milder cooling temperature-time profile as shown in the formulation in FIG. 6 Curve 2B. The milder and gentler cooling temperatures are particularly suitable for a certain population such as an infant, a toddler, or an elderly and the like

[0091] FIG. 7 is an exemplary embodiment of a transparent rigid therapy device. This example, together with examples in FIG. 6, show how the judicious combination of the HEM formulation and the material property and its thickness of the interface affects and regulates the temperature vs. time profile in the course of the cold therapy. Both Curve 1 and Curve 2 in FIG. 7 have the same interface material and thickness, that is, rigid polycarbonate at 0.9 mm thick, much thicker than the interface in the therapy devices in FIG. 6. Curve 1 and Curve 2 in FIG. 7 have different formulations, that is, different ratios of propylene glycol and water. Formulation in Curve 1 showed that, at 5 minutes, the therapeutic temperature reaches 9 C. (or 48 F.) while formulation in Curve 2A reaches 10 C. (50 F.), both are in the effective therapeutic temperature range. The lowest temperatures for Curve 1 at 10 minutes at 7 C. (45 F.) and Curve 2 at 12 minutes at 9 C. (48 F.). Both formulations maintain the lowest temperature plateau for about 10 minutes, again consistent with the known effective therapy temperature range and duration. The combination of the HEM formulation, the interface property and the interface thickness in FIG. 7 also demonstrates that, after the cold therapy, the temperature rises in the warm up cycle in a manner consistent with known recommendations.

[0092] FIG. 8 is the example of applying the therapy device for heat therapy. In FIG. 8, Curve 1 is replicating from Curve 1A in FIG. 6. Curve 2 is the heat therapy temperatures, demonstrating that the same therapy device can be used for both cold and hot therapy. The therapy device in FIG. 7 is heated in a given microwave oven for 80 seconds and the therapy device temperature has a surface temperature determined by a non-contact Infrared thermometer to be 140 F. (or 60 C.). Within 2 minutes of retrieval from the microwave oven, the heated therapy device is placed directly on the therapy skin surface and the therapy skin temperature-time profile is indicated in Curve 2 in FIG. 8. Curve 2 shows that the therapy device imparts a comfortable warm temperature to the therapy skin surface within a narrow range of 38 C. to 39.5 C. of skin surface temperature for the entire duration of 30 minutes. It is to be noted that the therapy device may start with a hot temperature higher than 140 F. (or 60 C.), by simply heating in the microwave oven for additional 15-30 seconds. However, at initial device temperature higher than 140 F. (or 60 C.), it is not recommended to be place on the therapy skin surface directly. The same cautionary practices of using a conventional heating pad applies in this case. Except the invention therapy device provides a temperature reading and allows the direct contact with the skins if pre-conditioning of the therapy device is done correctly.

[0093] By way of the following examples, it demonstrates that the invention therapy device can be placed directly on the therapy skin surface to generate controlled, regulated and effective cold or hot temperatures as a function of time to reach the desired therapeutic goals. The invention therapy device further provides transparency and visibility to allow a user or a care-giver to monitor the therapy skin surface in the event an intervention is required. By judiciously selecting and adjusting various parameters, including but not limited to, the HEM formulation, the interface material and its thickness, the therapy device can provide different temperature-time profiles to meet the needs of a wide range of injury types and user demographics.

Example 1

[0094] To prepare a thickened solution of 39% glycerol by volume and 61% water by volume, place 488 ml of DI water in a 1.5 L beaker on a magnetic stirring plate. Add 0.6 grams of liquid triethanolamine into DI to adjust the pH to 10.0 while stirring. The magnetic stirrer in the beaker is removed and 0.8 grams of carbomer 940 in fine powder form is added to the pH-adjusted DI water. Carbomer is a thickener specified as polyvinyl carboxy polymer crosslinked with ethers of pentaerythritol. Separately, 312 ml of neat phase glycerol is measured and placed in another beaker. A hand-held mixer is inserted into the DI and turned to high speed and mix the powdery carbomer into DI water. As the DI is being thickened, which takes about 20-30 seconds, glycerol was poured into the DI slowly while continuing mixing. The mixing continues for another 60 seconds until the mixture appeared to be homogeneous. The mixture solution is let stand at room temperature for about 24 hours until the bubbles settle and disappear. The solution has the viscosity of 50 centipoise and ready to use. Separately, the bottom half of the therapy device 403 as shown in FIG. 3A is formed with a cold crack rated Polyvinylchloride (PVC) Clear Flexible film at 0.4 mm, via thermal vacuum forming process and ready to use. The compartments are filled with the prepared glycerol and water mixture. 225 ml of HEM solution to the center compartment and 125 ml to each of the side compartment. Radio-frequency is applied to seal the bottom part (403) of therapy device cooling device to the flat top 402 film as shown in FIG. 3A. The top film in this example is the same PVC film except 0.8 mm thick, a result of laminating two 0.4 mm films together. The sealed therapy device is placed into a freezer at 2 F. for 24 hour.

[0095] After the flexible therapy device is retrieved from the freezer, it is placed on the unbroken skin surface of a healthy adult. The timer starts when the therapy device leaves the freezer and interface side (the 0.4 mm film side) of the therapy device is placed on the skin surface within 30 seconds after retrieval from the freezer. A thermocouple 511 of the digital thermometer 510 in FIG. 4A is placed in the center of the middle compartment of the cooling device (refer to FIG. 3A) and between the therapy skin surface and the interface of the therapy device (refer to FIG. 4A). Temperature recording starts at 1 minute after retrieval from the freezer. At 5 minutes, the digital thermometer reads 9.0 C., at 10 minutes 7.1 C., at 20 minutes 8.7 C., at 30 minutes 11.5 C. and at 60 minutes 16 C.

Example 2

[0096] This example utilizes the same transparent flexible cooling container with the same interface thickness and top film thickness as in EXAMPLE 1. The formulation is different, that is, 60% glycerol by volume and 40% DI water by volume, also with pH adjustment by triethanolamine and thickener Carbomer 940. Temperature recording for this formulation under same testing conditions are as follows: At 5 minutes, the digital thermometer reads 10.9 C., at 10 minutes 9.5 C., at 20 minutes 10.2 C., at 30 minutes 12.3 C. and 60 minutes 17.5 C.

[0097] EXAMPLE 3 utilizes a transparent rigid cooling device. The HEM Container has a slightly oval surface at length of 6.2 cm and width 4.0 cm (Refer to its cross-sectional view in FIG. 1B). The height of this coolant container is 3.5 cm. The rigid coolant container is made of polycarbonate material and the interface thickness is 0.9 mm. The HEM for this application is propylene glycol and water mixture at the volume ratio of 30% and 70% respectively. No other additives is added in this example. After 24 hours in a freezer, the therapy device is retrieved and the same measurement conditions specified in EXAMPLE 1 are followed to record temperature and time. The recorded time-temperature profile of the thermocouple between the therapy skin surface and the HEM Container interfaces are as follows: at 5 minutes 9.0 C., at 10 minutes 6.7 C., at 15 minutes 6.7 C., at 20 minutes 9.9 C., at 30 minutes 12.6 C. and finally at 60 minutes 21.2 C.

[0098] The foregoing has described the principles, embodiments, and modes of operation of embodiments of the present invention. However, the concept should not be construed as being limited to the particular embodiments described above, as they should be regarded as being illustrative and not as restrictive. Modifications and variations of the disclosed embodiments are possible in light of the above teachings. It is therefore to be understood that the present concept may be practiced otherwise than as specifically described herein. It should be appreciated that variations may be made in those embodiments by those skilled in the art without departing from the scope of the present invention.

[0099] 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 concept. It should be understood that various alternatives to the embodiments described herein may be employed in practicing the present concept. 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.