ADHESIVE TAPE FOR THERAPEUTIC USE

RELATED APPLICATION DATA

[0001] This application claims priority under 35 U.S.C. §119(e)(1) from United States Provisional Application Serial No. 62/924,406, filed October 22, 2019 , the entire contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This invention relates to elastic therapeutic tapes and wraps and methods of treating patients with combination therapies, and more particularly to tapes and wraps containing therapeutic material, which, after being introduced into the tape or wrap, still allow the tape or wrap stretch and recoil.

BACKGROUND OF THE INVENTION

[0003] There are many types of tapes and wraps used in medicine, ace bandages, medical adhesive wrapping tape, etc. One popular medical tape is elastic therapeutic tape, also called kinesiology tape, Kinesio tape, k-tape, or KT, is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability from athletic injuries and a variety of other physical disorders. The tape was invented by Japanese chiropractor Kenzo Kase in the 1970s. Strips of brightly colored tape adorning the arms, legs, and torsos of many top athletes, became world famous during the 2008 Olympics, and have increased in popularity since then.

[0004] Kinesiology tape is hypoallergenic and wearable for days at a time, for example, up to 4 days. The product is made from a type of thin, elastic cotton that can stretch up to 30%- 40% of its original length. Designed to mimic human skin, with roughly the same thickness and elastic properties, it is generally latex free and includes cotton fibers which allow for evaporation and quicker drying leading to longer wear time. How the tape is claimed to affect the body is dependent on the location on the body, and how it is applied; the stretch direction, the shape, and the location. Thelen MD, Dauber JA, Stoneman PD (July 2008). "The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial". J Orthop Sports Phys Ther. 38 (7): 389-95, which is hereby incorporated by reference herein. [0005] Kinesiology tape was designed to run with the contours of the skin. As a result, if the tape is stretched greater than its normal length, and then adhesively applied to the skin, it will "recoil" and create a pulling force on the skin (“kinesiologic effect”), and this force microscopically lifts the skin directly beneath it to create a small interstitial space between the muscle and dermis layers. That space potentially takes the pressure off swelling or injured muscles, allows smooth muscle movement and makes space for drainage and blood flow. This elastic property also allows much greater range of motion compared to traditional white athletic tape.

[0006] With the utilization of single “I” strips or modifications in the shape of an “X”, “ Y” or other specialized shapes as well as the direction and amount of stretch placed on the tape at time of application, Kinesiology tape can be applied in hundreds of ways and has the potential to reduce inflammation, prevent injury and promote good circulation and healing, and assist in returning the body to homeostasis.

[0007] While kinesiology is still a growing field and has the potential to treat many more types of injuries and conditions, there appears to be a need to provide even more functionality to standard tapes and wraps to provide greater therapeutic effect.

SUMMARY OF THE INVENTION

[0008] In a first embodiment of the invention, an elastic therapeutic tape adapted for adhesive application to the external skin of a mammal is provided. Elastic therapeutic tape includes an elongated fibrous layer; a pressure sensitive adhesive layer disposed proximate to a first surface of said elongated fibrous layer; and at least one therapeutic material disposed in or on said therapeutic tape; whereby when said tape is applied in a stretched form to said external skin, a portion of the external skin below said tape is gently lifted and the therapeutic effects of said therapeutic material are applied to a portion of the gently lifted skin to allow the therapeutic material, the effects of said therapeutic material, or both, to penetrate the skin and enter the blood stream of said mammal.

[0009] In a further embodiment of the invention an elastic therapeutic tape is provided with a said therapeutic material comprising a wireless, stretchable and flexible resistance heater, disposed between the elongated fibrous or fabric layer and the pressure sensitive adhesive layer for delivering heat therapy to said mammal. The resistance heater preferably comprises a conductive ink screen printed on a thermoplastic film. The therapeutic material of these embodiments can also comprises electrodes for delivering TENS therapy, EMS therapy, or both, whose power circuitry can include stretchable conductive inks. If the device is geared towards TENS or EMS therapy, the electrodes can be formed on a stretchable thermoplastic film.

[0010] In further embodiments, a therapeutic tape can be provided with a wireless, stretchable and flexible resistance heater comprising a wireless, carbon ink-containing heating element disposed between a pair of stretchable and flexible thermoplastic layer films. In all of the above embodiments, the therapeutic tape and said wireless, stretchable and flexible resistance heater contained therein can be configured in an “X”, straight “I” , or " Y" pattern.

[0011] In further embodiments, the elastic therapeutic tape comprises a transdermal substance and a wireless, stretchable and flexible resistance heater which provides heat to at least increase the rate of which the transdermal substance is delivered transdermally to a mammal. [0012] In still a further embodiment, the elastic therapeutic tape includes at least two endothermic cooling components, each of said components disposed within selectively sealed (friable or tearable, for example) thermoplastic, such as polyurethane (TPU), envelopes.

[0013] In another embodiment, an elastic therapeutic tape is provided wherein the at least one therapeutic material comprises one or more of the group consisting essentially of: a stretchable heating element, electrode for delivering TENS therapy, electrode for delivering EMS therapy, a transdermal active, an endothermic compound, and a cannabinoid.

[0014] This invention also provides a method of delivering a cannabinoid to a bloodstream of a mammal, comprising: providing an elastic therapeutic tape adapted for adhesive application to the external skin of said mammal, comprising: an elongated fibrous layer sized to conform to a portion of the external skin of the body of said mammal to provide for a gentle lifting force to the external skin portion when adhered thereon; a pressure sensitive adhesive layer disposed on a surface of said elongated fibrous layer; and a transdermal therapeutic substance containing a cannabinoid joined to said pressure sensitive adhesive layer and in contact with said portion of the external skin when said elastic therapeutic tape is worn; applying said tape while in a stretched form to the skin of said mammal whereby a portion of said skin is gently lifted below said tape; and allowing the cannabinoid to penetrate a portion of the skin which is gently lifted and allowing said cannabinoid to enter the blood stream of said mammal.

[0015] The preferred elastic adhesive tapes can be produced in any size, shape or pattern, in strip form, or as precut strips in roll form. Therapeutic effects can be generated and/or directed from a plane or in a combination of different planes. The preferred fabrics can be selected from a weave, woven, knit, non-woven fabric (film) or a combination of these fabrics, and each fabric selected can be of different weights and thicknesses. The fabric layers may be constructed with elasticity in either one or two directions (warp and weft, for example). In another example, the tape may constructed with the stretch component of the fabric insulating layers primarily in a warp direction that, upon application to the skin with stretch, will provide Kinesiology benefit when the skin lifts as the elastic tape attempts to recoil. By providing both therapeutic properties, such as heat and Kinesiology benefits, the tape become a multi-modality therapeutic product.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings illustrate preferred embodiments of the invention as well as other information pertinent to the disclosure, in which:

FIG. 1 A: is an exploded front perspective view of a tape embodiment showing a layered construction of an adhesive tape incorporating a carbon resistance heater of this invention;

FIG. IB: is a top planar view of the tape embodiment of FIG. IB;

FIG. 2: is an exploded front perspective view of a tape embodiment showing a layered construction of an adhesive tape incorporating a transcutaneous electrical nerve stimulation (TENS ) device;

FIG. 3: is an exploded front perspective view of a tape embodiment showing a layered construction of an adhesive tape incorporating a resistance heater, and electrodes for delivering TENS and EMS therapy;

FIG. 4: is an exploded front perspective view of a tape embodiment showing a layered construction of an adhesive tape incorporating a reusable self-powered, electrically heated, therapy system; FIG. 5: is an exploded front perspective view of another tape embodiment showing a layered construction of an adhesive tape incorporating a coiled patterned, self-powered resistance heater;

FIG. 6: is a bottom planar view of a target heater embodiment of this invention;

FIG. 7: is a side elevation, cross-sectional view of the target heater embodiment of FIG. 6;

FIG. 8: is a front perspective view of the target heater of FIG. 6 showing a rechargeable battery power pack;

FIG. 9: is an exploded front perspective view of another tape embodiment showing a layered construction of an adhesive tape incorporating a cannabinoid / adhesive delivery system;

FIG. 10: is an exploded front perspective view of another tape embodiment showing a layered construction of an adhesive tape incorporating a self-cooling, endothermic system;

FIG. 11 A: is an exploded front perspective view of another tape embodiment showing a layered construction of an adhesive tape incorporating a plurality of stretchable chambers for containing endothermic materials;

FIG. 11 B: is a side elevation, cross-sectional view, taken through line A- A of FIG. 11 A, of the tape embodiment having stretchable chambers.

DETAILED DESCRIPTION OF THE INVENTION

[0017] As shown in FIGS. 1A-11B, the preferred exothermically heated tapes 100, 200, 300, 400, 500, 600, 700, 800 and 900 and equivalent wraps are generally precut strips are made in a variety of widths, lengths and configurations. Depending on the brand, strip length varies from 1 - 12" and width from 1 - 4". The most common configurations are X, Y and I, as well as precut edema strips, which are specially designed to relieve swelling, edema and lymphedema. When the exothermic compound is incorporated in a wrap, it preferably does not utilize an adhesive backing to secure the system to the body. Its ability to stay in place during therapy can rely on it being mechanically secured to the body. This securement can be made with replaceable and removable adhesive pads which can be applied to the underside of the wrap and then adhered to the skin of a wearer, an adhesive tape applied on the wrap and then to the wear’s skin, elastic or mechanical straps, hook and loop materials, compression wear or some other mechanical means. In certain other embodiments, the adhesive pads can include a transdermal active, or the adhesive pads can be substituted with adhesively applied hook and loop fastener pads (one of which can be applied to the skin of the wearer and may also contain an optional transdermal active).

[0018] The preferred exothermically heated wraps or tapes 100-900 are preferably, in appearance and feel, not substantially different than a wrap or a strip of medical and kinesiology tape without the therapeutic materials, excluding possibly the battery pack 5 (shown in tape 100, FIG. IB, and power pack 25 of target heater 600, FIG. 8) but also similarly provided as a fixed or removable power pack in tapes 200-500). The wraps or tapes 100-900 are able to flex, stretch and contour to the skin in substantially the same way as untreated fabric does.

Tape and Wrap Embodiments Generally

[0019] The unique construction of the preferred exothermically heated elastic adhesive tapes 100 -900 and wraps of this invention is such that, because they are elastic, and able to stretch, flex and contour to the skin, they allow the therapeutic effects, such as heat or cold generated within the tape, to remain against or near the skin as the body moves. The therapeutic material is preferably insulated on the top side (non-skin side) by a layer of thermally insulating elastic fabric 1, 101, 201, 301, 601, 12, 801 and 901,902 such as woven cotton, neoprene fabric or other natural or synthetic materials mentioned below, in order to minimize heat loss to the atmosphere, insulate heat loss, or reflect heat either radiantly or conductively back to the wearer. [0020] Stretch fabrics are either 2-way stretch or 4-way stretch. 2-way stretch fabrics stretch in one direction, usually from selvedge to selvedge (but can be in other directions depending on the knit). 4-way stretch fabrics, such as spandex, stretches in both directions, crosswise and lengthwise. Stretchy materials refers to fabrics which can stretch without breaking the fibers and return to its original length. This stretch of the fibers provides the preferred tapes and wraps of this invention made with them the much needed ease, drape, comfort and fitting. See https://sewguide.com/stretchy-fabric/, which is incorporated herein by reference.

[0021] Knits:

[0022] Most of the knit fabrics have some stretch. Usually, it is a 2-way stretch, with less stretch in the weft direction. The stretch of a knit fabric makes it one of the most suitable fabric for tape and wraps. Jersey is a light to medium weight knit fabric with good stretch. Other suitable knit fabrics are: 3x3 Rib Knit, Bamboo Jersey, Doubleknit Rayon Blend, Interlock twist jersey, Double knit, Sweater Knit, Silk Mesh Knits and Silk Jersey.

[0023] Spandex:

[0024] Also suitable for this invention are Spandex fabrics, which is a generic name for stretchy fabrics with elastic content - the base could be cotton, nylon or wool and Lycra, a spandex fabric which is trademarked by Dupont Company. Its ability to stretch to almost 300- 400 percentage on its own. The stretchiness of Spandex depends on its elastane content; 1-5% is desirable, whereas for sportswear an elastane content of about 12-15% is more preferred Spandex blends

[0025] Spandex Blends:

[0026] When blended with other fibers spandex can lend about 2-20 % of its elasticity to the new fibers.

[0027] Cotton - spandex blend - Very smooth fabric with a 4 way stretch. The percentage of spandex usually is 3- 5%. It can be used to make tape and wraps.

[0028] Polyester - spandex Blend - This is very lightweight stretchy material with stretch;

[0029] Stretch satin -This is a polyester -spandex blend in a satin finish;

[0030] Stretch velvet - This fabric with a napped surface can have about 15% stretch ; and

[0031] Polyester spandex fabric with or without foam backing. [0032] Nylon Spandex Fabric - This stretchy material can be used for active or sports applications. It has a very nice 4 -way stretch (15% spandex mostly). Tricot (Italian Tricot etc.) is a Nylon Spandex which has 25-50% stretch.

[0033] Rayon knit /Spandex - this has a good stretch and it is a very silk like smooth. This combination make it ideal for making very fitting and comfort against the skin. Bamboo rayon is especially smooth.

[0034] Acetate/Spandex; Modal/Spandex; Tencel/Spandex; Linen/ Spandex are other blends which are available.

[0035] Stretch Denim is a lightweight denim with a stretch for comfort and ease. It is a mix of cotton, polyester and spandex.

[0036] Cotton poplin stretch is a stretchy fabric is a blend of Poplin, cotton and spandex - this fabric usually has a slight (10%) stretch and is very comfortable.

[0037] Rubber/Latex:

[0038] Latex is made from the sap of the rubber tree. Rubber can be used to make tape and wraps but may not be suitable for extended use. It is has little to no breathing ability and at times may be irritating to skin, but can be perforated. But the stretch of rubber is even more than even spandex and water resistance makes it desirable for certain applications.

[0039] Neoprene Rubber:

[0040] Neoprene rubber is a synthetic polymer resembling rubber. Wet suits used in scuba diving are usually made of Neoprene rubber. Neoprene rubber is available in many thicknesses and can be used to make wraps and tape with the heating elements of this invention, especially when provide in breathable or perforated form.

[0041] And finally woven fabric can also stretch - when it is cut on the bias. So if you want the advantages of a woven fabric, it can be cut on the bias grain i.e. along a line drawn 45 degrees to the lengthwise and crosswise grain of the fabric, to provide more of a stretch.

[0042] The preferred tape of some embodiments is a non-linear elastic and porous composite material. Warp yarns are core-spun elastic yams, while weft yarns are 100% cotton yarns. Fabric has a plain weave and its back side is equipped with an adhesive. Preferred tensile strength of kinesiology tape ranges from 80 to 180 N depending on the tape width. In a relaxed state, porosity together with air permeability and other heat and mass transfer characteristics are mainly affected by the compact layer of adhesive on the surface of woven fabric. During tensioning, pores are expanding and therefore transfer of air and water vapor is significantly increased and at the same time heat transfer is reduced which can positively affect wearer comfort. Kinesiology tape is hypoallergenic and wearable for days at a time, for example, up to 4 days. The product is made from a type of thin, elastic cotton that can stretch up to 130%-140% of its original length. Designed to mimic human skin, with roughly the same thickness and elastic properties, it is generally latex free and includes cotton fibers which allow for evaporation and quicker drying leading to longer wear time. How the tape is claimed to affect the body is dependent on the location on the body, and how it is applied; the stretch direction, the shape, and the location. Thelen MD, Dauber JA, Stoneman PD (July 2008). "The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial". J Orthop Sports Phys Ther. 38 (7): 389-95, which is hereby incorporated by reference herein.

[0043] Kinesiology tape was designed to run with the contours of the skin. As a result, if the tape is stretched greater than its normal length, and then adhesively applied to the skin, it will "recoil" and create a pulling force on the skin, and this force microscopically lifts the skin directly beneath it to create a small interstitial space between the muscle and dermis layers. That space potentially takes the pressure off swelling or injured muscles, allows smooth muscle movement and makes space for drainage and blood flow. This elastic property also allows much greater range of motion compared to traditional white athletic tape.

[0044] With the utilization of single “I” strips or modifications in the shape of an “X”, “Y” or other specialized shapes (see Figures 4 and 5) as well as the direction and amount of stretch placed on the tape at time of application, Kinesiology tape can be applied in hundreds of ways and has the potential to reduce inflammation, prevent injury and promote good circulation and healing, and assist in returning the body to homeostasis.

[0045] Preferred properties of kinesiology tape of this invention include: up to 100% made from a gentle cotton fiber strip; up to 100% medical grade acrylic adhesive; up to 100% latex-free; Hypoallergenic; Water-resistant; Does not limit range of motion; Multiple day wear time and Applied tension on the tape has the potential ability to relax or stimulate muscles.

[0046] In further preferred embodiments, the fibrous layer is a relatively isotrpically stretchable and flexible layer that can be machine or hand washable for up to 100 times with falling apart or rendering the heater inoperable. In further embodiments, the resistance heating carbon ink element is sealed with in a preferred thermoplastic film, such as TPU, on both the top and bottom surfaces. This sealed heating unit can then be heat bonded to a washable fabric, such as neoprene, spandex or cotton knits.

[0047] The unique construction of the resistance heater is such that, there are preferably no wires or conductive metal yarns used to convey power or used to form the heating element. It is desirably a wireless system. Likewise, no external temperature controlling device is preferably required, as temperature control can be accomplished via a self-regulating carbon based ink.

[0048] Flexible printed heaters are warming elements. They can be manufactured to add heat to medical tape and wrap products, clothing, etc.; Precision screen printing is used to print conductive inks, such as silver ink bus bars, or resistive inks, such as carbon ink heating elements, on flexible materials. The conductive and resistive inks are preferably stretchable and flexible, and retain at least some of their electrically conductive and resistive heating properties over the full Design Operating Temperature range after being stretched. They preferably have the same or similar stretch as the material they are applied to, such as TPU or stretchable fabric, e.g., up to 180% stretch, preferably 130%-150% for kinesiology tape and about 10-80%, preferably about 5-20% for flexible reusable wraps and other types of tapes (such as tapes having large areas of TPU material).

[0049] The inks are typically comprised of both resistive and conductive materials, including functionally resistive carbon and/or conductive silver. This makes it possible to create different solutions to cater to unique needs and specific requirements. Common print substrates are polyester, polycarbonate, or polyimide - Kapton RS conductive films, Neoprene, stretchable cotton, like KT tape, and stretchable non-wovens, such as Lycra, etc. The printed heaters can also be printed on polymeric “carrier” layers, such as thermoplastic polyurethanes known as TPU, such as DuPont Intexar TPU. TPU substrates are useful because of the flexibility and elasticity of the material. The flexible construction of the system due to these materials, conforms to the curves and build of the human body, allowing the user to move freely and not restrict activity or mobility. The printed heater systems can be applied to very thin films and will not add any significant weight to the products they are applied to. In the case of preferred flexible tapes and wraps of this invention, the printing is preferably performed on thin TPU substrates and then these TPU substrates are transferred or carried to textiles and joined together using heat transfer. See https://butlertechnologies.com/what-are-flexible-printed-hea ters/, which is hereby incorporated by reference. Preferably the polymer carrier layers, like TPU layers, are also breathable (permeable to air) or perforated, or made to be that way when stretched upon use. In other embodiments, the applied inks are applied to be disposed within a pair of polymer carrier layers comprising: A first polymeric layer and then a second polymeric layer applied over the applied ink, which is then heat sealed, or ultrasonically or adhesively bonded, to form a sealed or breathable intermediate composite made of an ink layer joined between a pair of polymeric layers. One of the outer surfaces of these polymeric layers can then be later bonded to a stretchable fabric layer. Alternatively, the polymeric layers can be printed, rolled or sprayed polymeric coatings or films disposed over the ink layer so that air spaces are provided through the composite and the final tape or wrap is breathable when worn. The polymeric layers can be discontinuous, in the form of a mesh, screen or scrim, or non-woven fabric, so they are breathable in the final assembly.

[0050] In certain embodiments of this invention the printed inks are applied or printed on an intermediate or carrier polymeric layer, such as a TPU layer, since printing on the fabric or textile layer directly produces small undulations and imperfections in the conductive and resistive inks which could make them defective. Also, it is desirable to do the printing, (or mass produced roll printing used in roll-to-roll or in-line mass production printing), on the polymeric carrier layer while it is not fully stretched, so as to avoid cracking or delaminating the printed heater circuit when the tension is removed. For example, some stretch can be used to suspend the polymeric layer on a platen for printing, or during tentering, for example, when the polymeric layer stretches its width under tension by the use of a tenter frame during roll printing. Desirably this stretch is less than 80%, and is preferably less than 20%, during the application of the inks. More, desirably, when the applied inks are conductive and resistive elements, like those of the preferred embodiments, the unstretched state of the system should have a maximum temperature to be comfortably worn against the skin or clothing of the wearer, for example, 110 F, and when fully stretched, the system should have a minimum temperature to provide therapeutic heat, for example, about 100 F. The preferred resistive inks compositions can be selected to have an inverse relationship between stretch and heat generation, as the resistance of the carbon ink can be formulated to increase as the system stretches until the heating element shuts off completely, when the system is fully stretched, for example within the range of about 125-165% for kinesiology tape or within the range of about 10-80% for reusable wraps and other tapes. [0051] Positive Temperature Coefficient (“PTC”) heaters are safe, have elasticity, flexibility and ease of use. PTC heaters provide safe and comfortable low heat. PTC carbon ink heaters work by providing electrical resistance when they conduct electric current and heat up when current is applied. In one preferred embodiment, screen-printed PTC heater utilizes a silver BUS system with self-regulating carbon heating elements. This means that the printed heater is capable of regulating its temperature without any outside controls. When power is applied, the resistance increases and limits the electrical current to the heater causing it to cool. As the heater cools, electrical current will increase again causing it to reach its operating temperature, thus self-regulating. This creates a safe and efficient warming element which potentially eliminates the risk of overheating. The preferred flexible printed PTC heaters provide uniform heat with no hot spots, require less power to operate and are safer to use due to their cold-state failure mode. The PTC Heaters can be printed on flexible material, like TPU. Alternatively, the printed heater could have a printed or conventional electronic thermistor or printed or conventional thermostat element.

[0052] Precut strips make the preferred heated kinesiology taping faster and more convenient by eliminating the need to use scissors to cut rolls of tape. Because they are machine cut with rounded comers, precut strips have less fraying than kinesiology tape cut with scissors.

[0053] The preferred heated Kinesiology tape precut strips are made in a variety of widths, lengths and configurations. Depending on the brand, strip length varies from 5 - 12" and width from 1 - 4". The most common configurations are X, Y and I, as well as precut edema strips, which are specially designed to relieve swelling, edema and lymphedema.

[0054] The heated therapy system is preferably, in appearance and feel, no different than fabric (such as kinesiology tape without adhesive) without the resistance heater. The heated therapy system is able to flex, stretch and contour to the skin in substantially the same way as unheated fabric does.

[0055] Power is preferably supplied via a low voltage battery source that snaps onto the base assembly, thereby, completing the heated therapy system. In one embodiment, the battery source is rechargeable. Alternatively, the option exists to connect a remote power source, using a pair leads that may snap to the base assembly in place of the local power source that would normally be integral with the heated therapy system. [0056] The heated therapy system of some embodiments, preferably, does not utilize an adhesive to secure the system to the body. Its ability to stay in place during therapy can rely on it being mechanically secured to the body with a removable adhesive patch, which can be applied to the underside of the wrap and then adhered to the skin, an adhesive tape applied over the system and then to the wear’s skin, replaceable adhesive pads, elastic or mechanical straps, hook and loop materials, compression wear or some other mechanical means. In one embodiment, a fibrous layer is provided with a neoprene layer sandwiched between a pair of nylon fabric layers. In another embodiment, the fibrous layer is a neoprene layer (or other stretchable fabric) sandwiched between a nylon fabric top layer and a bottom unbroken loop (UBL) fabric layer, which is then selectively applied to replaceable adhesive pads on the wearer’s skin, which have hook fasteners (e.g. Velcro) on their exposed top surface, so that the UBL fabric on the underside of the fabric layer can be reversibly adhered. It can also be useful to locate the UBL fabric on the replaceable adhesive pads, while providing the bottom surface of the neoprene layer with a hook fastener layer.

[0057] In one embodiment, the pair of snaps that are used to mechanically connect the power pack to the system, are also the means by which power is transferred between the power pack and the heater. An on/off switch, incorporated into the power pack, enables the wearer to "power up" the heated therapy system, heating it to a desired temperature, for example, 100-110 degrees F, for a desired time, for example 15-60 minutes, more preferably up to about 30 minutes, before automatically powering off. A power pack feature can provide the user with an option to choose a lower temperature setting.

[0058] Since the heated therapy system is preferably not relying on a one-time use adhesive layer to hold it in place, it may be reused, over and over again. The system is preferably machine or hand washable, without damage to the heater or its circuitry, making it hygienically practical for continued reuse.

[0059] And, because it is preferably self-powered, and preferably not utilizing remote wires for its power, it may be worn seamlessly for extended periods of time, allowing the user to go about daily activities, only "powering up" when a therapy session is desired. The ergonomically friendly heated therapy system may be worn underneath clothing, or adhesively attached to clothing, for concealed pain relief therapy. [0060] The system’s power source is preferably designed to be recharged, or removed and replaced with another power pack with fully charged batteries. The batteries can sustain up to 100-1,000, and preferably at least 500 re-charges before requiring replacement.

[0061] Additionally, the therapeutic material can be insulated on the underside by another optional layer of thermally insulating elastic fabric, such as lower fabric layer 902 in FIG. 10 that is designed to protect the skin from any potential for adverse effects of the endothermic reaction, such as cold spots, while allowing the cold to penetrate through to the wearer. This lower layer of thermally insulating elastic fabric preferably conducts some cold temperatures, but optionally, can also spread heat more uniformly. The upper and lower layers should have stretch properties, of at least about 10-30 % elasticity at the low end, for flexible and drapeable bandages and tape, to as high as 30%-90%, preferably about 65% elasticity, at the upper end, for kinesiology tape and ace bandage type wraps.

[0062] The resistance heating area of embodiments 100, 200, 300, 400 and 500 is preferably about .5-1.5”, preferably about 1” in width, and about 5-20”, preferably about 9”, in length. The overall thickness of the tape embodiments 100, 200, 300, 400, 500, 700, 800 and 900, is about .06- 5”, preferably about .125- 25”.

[0063] The preferred tape embodiment is able to flex, stretch and contour to the skin in a similar way as unheated adhesive tape. And, if the stretch component of the thermally insulating elastic fabric layers 1, 101, 201, 301, 601, 12, 801 and 901,902 is primarily in the warp direction, or anisotropic, when applied to the skin, the recoil and skin lifting effect provides for a Kinesiology benefit, making it a multi-modality therapeutic product.

[0064] The system is preferably designed as a one-time use product. Once the exothermic reaction period is complete, the product may be removed or remain in place for added Kinesiology benefit. [0065] The preferred tapes 100-900 and wraps of some embodiments is a linear or non linear elastic and preferably also an oxygen and water vapor porous composite material. Preferred tensile strength of kinesiology tape ranges from 80 to 180 N depending on the tape width. In a relaxed state, porosity together with air permeability and other heat and mass transfer characteristics are mainly affected by the compact layer of adhesive on the bottom surface of the tape. During tensioning, pores are expanding and therefore transfer of air and water vapor can significantly be increased and at the same time heat transfer is reduced which can positively affect wearer comfort.

[0066] The preferred tapes 100-900 and wraps are hypoallergenic and wearable for days at a time, for example, up to 4 days. For kinesiology tape applications, the tape 100-900 can stretch isotropically up to 10%-90% of an original dimension in all directions, preferably about 25%-65%, or anisotropically, up to 10%-90%, preferably about 25%-65% of its original length in the warp direction and about 5-20%, preferably about 10% of its original width in the weft direction. For other applications, such as wraps, drug delivery or pads, the product can have much less stretch, and can be closer to isotropic in stretchability, such as about 1-10% in the warp direction and about 1-10% in the weft direction.

[0067] The fabric used for the tape 100-900 or wrap is preferably designed to mimic human skin, with roughly the same thickness and elastic properties as human skin. It can be generally be latex free and can sometimes preferably include fibers, film or material which allows for the evaporation of liquid water (sweat) and quicker drying leading, which can lead to longer wear time. The weight of the fabric can be about 75 gsm (when exothermic compound is later to be added), and about 160 gsm if no exothermic material is added. How the tape is claimed to affect the body is dependent on the location on the body, and how it is applied; the stretch direction, the shape, and the location. Thelen MD, Dauber JA, Stoneman PD (July 2008). "The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial". J Orthop Sports Phys Ther. 38 (7): 389-95, which is hereby incorporated by reference herein. [0068] The tapes 100-500, 700-900 are designed to run with the contours of the skin. As a result, if the tape is stretched greater than its normal length, and then adhesively applied to the skin, it will "recoil" and create a pulling force on the skin, and this force microscopically lifts the skin directly beneath it to create a small interstitial space between the muscle and dermis layers. That space potentially takes the pressure off swelling or injured muscles, allows smooth muscle movement and makes space for drainage and blood flow. This elastic property also allows much greater range of motion compared to traditional white athletic tape.

[0069] With the utilization of single “I” strips or modifications in the shape of an “X”, “Y” or other specialized shapes as well as the direction and amount of stretch placed on the tape at time of application, the preferred tape 100-500, 700-900 can be applied in hundreds of ways and has the potential to reduce inflammation, prevent injury and promote good circulation and healing, and assist in returning the body to homeostasis.

[0070] Preferred properties of the tape 100-900 of this invention include: waterproof or water resistant, antimicrobial, biocompatible, up to 100% medical grade acrylic adhesive; up to 100% latex-free, hypoallergenic, does not limit range of motion, capable of multiple day wear time and the ability of applied tension on the tape to potentially relax or stimulate muscles.

[0071] In further preferred embodiments, the tape 100-500, 700-900 or wrap is a relatively isotropically stretchable and made of a flexible combination of layers that is disposable, since the exothermic material is generally for single use.

[0072] This tapes 100-900 can be sealed together and/or along their edges, by adhesively bonding, heat, sonic bonding, RF welding, or using a combination thereof, for example, and then similarly bonding the sealed heating unit to a disposable or washable fabric having a basis weight of about 75-250 grams per square meter (“gsm”), such as fabrics selected from: 3-10 wt. % spandex / 90-97 wt. % cotton, polyester, rayon or nylon weaves; 100% cotton, polyester, rayon or nylon knits; or 50 wt. % nylon-50 wt. % polyester knitted blends. [0073] Alternatively, a composite can be made by coating one or both sides of such woven or knit fabrics with an elastic polymeric layer, such as spun bonded fibers or a thermoplastic film, or a roll applied coating of thermoplastic film, such as a TPU film. Such composites can then be used as the preferred endothermic compound sealing layers or elongated elastic layers and/or fabric layers.

[0074] The tapes 100-900 should be breathable when worn, so that each of the recited layers: 1,2, 3, 4 in tape 100, layers 101,102,103,108,109,104 in tape 200, layers 201,202,203,222,223,208,209,204 in tape 300, layers 301,302,303,322 of tape 400, layers 601,602,603 and 604 in tape 500, layers 12,14,16,18 of tape 600, layers 801 and 824 of tape 700, layers 301,302,303,322 of tape 400, layers 901,902,923,926,927,902,928 and 904 of tape 800, and layers 930 and 931 of tape 900, should either be breathable (to air or oxygen, as well as water vapor) or made to be so when stretched and worn.

[0075] Ideal dimensions of the endothermic material component can include a thickness of about 1/16-1/8 inches (1-4 mm) and width of about .25- 50 inches (6.35-13 mm), which can then be subdivided into sections or packets in separate shingles or in seamed compartments 931 of tape 900, FIG. 11, or along the diamond shaped containers or a serpentine path, for example. This subdivision allows the endothermic reaction and resulting cold to be more uniformly distributed along the tape or wrap, when worn on the body vertically or horizontally, or when stretched or unstretched.

[0076] By providing heat, cold, cannabinoid, TENS, EMS, and/or transdermal actives, for example, the wrap or tape 100-900 provides a dermal, muscle and blood flow therapy. When a body is warming up, prior to a work-out or exercise, increased blood flow due to heat therapy to the muscles, bones and surrounding tissue is known to be of enormous benefit for the purpose of preventing injury. Additionally, stimulating blood flow is useful in providing pain relief and, in general, for advancing the healing of the body.

[0077] EMBODIMENT 1: AN ADHESIVE TAPE INCORPORATING A CARBON

INK RESISTANCE HEATER [0078] Without heat, the blood flow is only minimally increased to the body part that is taped. Embodiments described herein provide heat without wires and with no different tactile feel or appearance as compared to current adhesive tapes in the market. The embodiments described in this section provide therapeutic heat stimulation to application areas. The adhesive tape can also be used while wearing clothing.

[0079] Preferred embodiments described herein provide heat preferably without wires and with no different feel or appearance as compared to current adhesive tapes in the market. Various embodiments described herein include: screen conductive inks for power and resistance heater circuitry onto thermoplastic film, die-cut thermoplastic film for sizing and for the relief ports that facilitate breathability and stretch requirement, laminate die-cut thermoplastic film to fabric, laminate adhesive to heater side of the fabric, die-cut assembly to final size.

[0080] The embodiments may include screening carbon based inks to a thermoplastic film, located between the fabric and adhesive layer. When powered, the heating element is preferably self-powered, e.g. battery-powered. These embodiments can be manufactured through a multi- stage layering of fabric 1 ( and 101, 201, 301 and 601), printed carbon ink resistance heater 3 (and 103, 203, 303, 603), or electrode 223, thermoplastic layers 2, (and 102, 202, 222, 302, 322, 602) , which make contain vent holes 6, and can be heat laminated, bus bars 7 (and 107, 201, 217, 307), preferably made from printed silver -containing ink, and pressure sensitive adhesive layers 4 (and 104,204,604), with or without release liners (not shown in FIG 1 A, but shown as 110, 210, 610 elsewhere), made of e.g. waxed Kraft paper. These embodiments 100- 500 are preferably used by applying the adhesive tape (except heater 400, which does not show adhesive) to a selected area of the body to transmit heat without wires. They are also flexible, stretchable and breathable. Also, they can provide heated stimulation to application areas and can also be used while wearing clothing as a concealed therapy.

[0081] WIRELESS HEATER TAPE PRODUCT OVERVIEW [0082] The heated tape 100 is based upon incorporating a carbon ink based, resistance heater into an elastic adhesive tape. The purpose of adding heat to the tape, is to complement the existing blood flow stimulating effect of the tape, as used on humans and animals, with the application of heat, a known stimulant of blood flow. Increased blood flow to the muscles, bones and surrounding tissue is known to be of enormous benefit, as it relates to "warming up" prior to work-out or exercise, for the purpose of preventing injury. Additionally, stimulating blood flow is known to aid in pain relief and to provide on-going, injury or disease related, therapy.

[0083] The unique construction of the resistance heater is such that, there are preferably no wires or conductive metal yarns used to convey power or used to form the heating element. It is ideally a wireless system. Likewise, no external temperature controlling device is required, as control is accomplished via a thermally self-regulating carbon based ink. The adhesive tape is, in appearance and feel, not significantly different than adhesive tape without the resistance heater. The adhesive tape is, therefore, able to stretch, adhere and contour to the skin in much the same way as unheated adhesive tape does. Power is preferably supplied via a low voltage, rechargeable, snap-less, battery source. Upon applying the tape to the skin, a small power pack 5 shown in FIG. IB, and not shown in FIGs 2-5, is secured to the tape. An on/off switch, incorporated into the power pack, enables the wearer to "power up" the adhesive tape 100-500, allowing it to heat to a specific temperature for a specific period of time. The heated adhesive tape or heater without adhesive 100-500 may be applied to the skin for a period of as little as few hours, or for as long as 10 days, without being removed. The tape or heater 100-500 may be worn underneath the clothing, without any discomfort, for concealed pain relief. As long as the tape or heater 100-500 is in place, the wearer can power up for a therapy session as desired.

[0084] The power source is designed to be easily recharged in place, or removed and replaced with another power pack with fully charged batteries, should the desired heating period be longer than the initial charge will permit. The heated adhesive tape or heater 100-500, once removed, becomes a throw-a-way product, while the power pack can be retained for use on the next adhesive strip.

[0085] WIRELESS HEATER TAPE SYSTEM COMPONENTS

FABRIC FEATURES: [0086] The printed carbon ink resistance heaters 3,103,203,223,303,603 will work with any type of fabric 1,101,201,301 and 601, synthetic or non- synthetic. The preferred fabrics are breathable and moisture wicking, heat sealable to thermoplastic film (either mechanically or chemically bonded); non-elastic or elastic in either one or two directions and water and liquid repellant.

[0087] ADHESIVE FEATURES:

[0088] The preferred pressure sensitive adhesive layers 4,104,204,604 for heated tapes 100-500 and 30, 824, 904 for tapes 600-900, can be one or more of the following: skin friendly (tested for and meets the ISO 10993 standards for skin sensitization and irritation); latex free, hypoallergenic, moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR), breathable - for adhesive and skin stability, and stretchable - to accommodate the required characteristics of the adhesive tape and repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

[0089] RESISTANCE HEATER FEATURES: the resistance heating area layer 3 of tape 100 in FIG. 1 A and 1 B, preferably has the following technical requirements (each within a range of +/- 20% of the number shown):

- Input Voltage - 7.4 volts

- Watts - 3 watts.

- Current - .4 amps.

- Design Temperature - 110 F.

- Heating Duration - 60 MINUTES

- Wireless - utilizes conductive inks in place of wires, or conductive metal yarn.

- Stretchable and flexible printed inks - may be required to accommodate the stretchable/flexible specifications of the adhesive tape system.

With reference to FIG. 1, tape 100 includes a base fabric layer 1 disposed on a thermoplastic layer 2, which in turn, is attached to a conductive ink layer 3 and a silver ink bus bar 7 (which runs along the entire length on both sides of the conductive ink layer 7), followed by an adhesive layer 4, which is covered by a release film layer (not shown).

[0090] Thermoplastic film layer 2 preferably has vent holes 6 for providing a stretchable, flexible, breathable, ink drying temperature tolerant, stable base on which to screen the conductive inks. Power circuitry is preferably made from stretchable, conductive, silver inks, such as bus bars 7. Heater circuitry is preferably made from custom compounded, stretchable, carbon ink. The resistance heating area 3 design can be a checker board pattern of carbon ink, with a watt density that meets the design operating temperature, and provides uniform, hot spot free, heat coverage to a large percentage of the fabric surface. The heater’s temperature control is preferably a Positive Temperature Coefficient self-regulating carbon ink. Self-regulating can mean that, as the temperature increases and decreases, the resistance of the ink increases and decreases, effectively turning the power on and off, or higher or lower, in order to maintain the system design temperature.

PREFERRED POWER CONFIGURATION:

- POWER SOURCE - (2) 3.7 volt, 600mAh, Lithium rechargeable batteries.

- POWER PACK 5 - designed for easy removal or installation, watertight, accommodates 2 batteries, an on/off switch and power indicating LED.

- POWER CONNECTION - via snap free, positive, connection.

The preferred construction sequence includes: Screen printing conductive inks for power and resistance heater circuitry onto the thermoplastic film 2; Die-cut thermoplastic film 2 for sizing and for the relief ports (vent holes 6) that facilitate breathability and potential stretch requirement; Laminate die-cut thermoplastic film to fabric 1; Laminate adhesive 4 to heater side of the fabric 1; and Die-cut assembly to final size.

[0091] EMBODIMENT 2: A SELF POWERED ADHESIVE TAPE INCORPORATING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION THERAPY

[0092] The product is based upon incorporating Transcutaneous Electrical Nerve Stimulation (TENS) therapy into a self-powered adhesive tape. [0093] In TENS therapy for pain management, a remote, battery-operated device delivers low-voltage electrical current through the skin via electrodes placed near the source of the pain. The electricity from the electrodes stimulates nerves in the affected area and sends signals to the brain that "scramble" normal pain perception.

[0094] Existing TENS units are an ergonomic nightmare. They are awkward and cumbersome to use, being anything but user friendly.

[0095] Issues with the current state of art:

- A low voltage electrical current is carried through wires, running between the controller and a pair of electrodes. Wires suspended from the body are awkward. A tug on a wire may easily pull free the electrodes or even dislodge the controller from its resting place.

- Restricted movement during therapy. With wires suspended from the body, one’s movement is typically restricted. If one electrode comes free, the therapy stops and potential damage to the control is possible, if the unit is not quickly shut down.

- The control unit must be held by hand or safely placed where it remains in proximity to the electrode leads. If the patient moves, the control, being remote, must also move with the patient.

- All prior art TENS devices use wires to send electrical current to the electrodes. As a result, for most areas of the body, the user must remove clothing during the therapy session.

[0096] Tape 200 will eliminate the above problems and, in doing so, will not only allow TENS therapy to be used more effectively but, will make the therapy more accessible to many more people. With reference to FIG. 2, tape 200 includes a base fabric layer 101 disposed on a thermoplastic layer 102, which in turn, is attached to a conductive ink layer 103 with electrodes (two shown) and a silver ink bus bar 107, followed by a pair of spaced hydrogel layers 108, followed by a pair of spaced masking layers 109, which in turn are then layered with an adhesive layer 104, which carefully leaves open windows where the masking layers 109 will access the skin. Finally the adhesive layer is covered by a release film layer 110. [0097] The unique construction of the TENS tape 200 is such that, there preferably are no wires or conductive metal yarns used to convey power to the electrodes. The electrodes are embedded within the adhesive tape and, as such, are integral with the tape and cannot easily come free from contact with the skin. No external controlling device is required, as control is accomplished via a rechargeable power pack (roughly the size of a pack of gum, not shown) that is directly attached to the tape. Upon applying the tape 200 to the skin, the tape is "powered up". A push switch on the power pack is available to adjust the intensity of the TENS signal. The TENS adhesive tape is, in appearance and feel, not significantly different than adhesive tape without TENS. The TENS adhesive tape 200 is, therefore, able to stretch, adhere and contour to the skin in exactly the same way as adhesive tape without TENS. As the control is integral with the tape, the cumbersome issue associated with existing TENS units does not exist.

[0098] Because the system is wireless, and the adhesive tape is paper thin, it may conveniently be worn beneath ones clothing for concealed therapy, eliminating the need to be in a "therapy" environment. Sleeping, bathing, and exercising with the TENS tape in place has no negative effect on the tape. The skin friendly adhesive system of the TENS tape will not allow the tape to come free or irritate the skin. The adhesive tape, once removed, becomes a throw-a way product, while the power pack is retained for use on the next adhesive strip.

[0099] SYSTEM COMPONENTS FABRIC :

[0100] While the system is conducive for use with any fabric, certain characteristics are preferred as follows: A fabric with high moisture wicking characteristics; A fabric with breathable characteristics; One that is conducive to heat sealing with thermoplastic film; One that has water repellant characteristics; May be stretchable, in one or two directions; One that has Antibacterial properties. [0101] TAPE ADHESIVE: preferably: Non conductive; Skin friendly - tested for and meets the ISO 10993 standards for skin sensitization and irritation; Latex free; Hypoallergenic; Moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR); Breathable - for adhesive and skin stability; Stretchable - to accommodate the required characteristics of the adhesive tape; Repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

[0102] TECHNICAL SPECS:

- TENS Channels: 1.

- Pulse Intensity: Adjustable, from 0 - 60mA.

- Maximum Output Current: 60 mA at 500 Ohm load.

- Waveform: Bi-Phasic.

- Automatic Power Off: 30 Minutes.

- Energy saving feature.

- Wireless: utilizes conductive inks in place of wires, or conductive metal yarn.

- Electrodes: Flexible conductive carbon ink & HydroGel conductive adhesive.

- Thermoplastic Film: Required as a stretchable, flexible, breathable, ink drying temperature tolerant base on which to screen the power and electrode circuitry inks.

- Power Source: (1) 3.7 Volt, 600 mAh Lithium Rechargeable Battery.

- Power Circuitry - from stretchable, conductive, silver inks.

- Power Pack : Molded plastic watertight housing.

- Switches: (2) tactile feedback with light, for On/Off & pulse intensity functions.

- Power Connection: Snap, to facilitate easy removal and installation.

[0103] CONSTRUCTION SEQUENCE:

Referring now to tape 200 of FIG. 2: 1. Screen conductive ink layer 103 and bus bar 107 for power and electrode circuitry onto thermoplastic layer 102.

2. Die-cut thermoplastic layer 102 for sizing and for the relief ports (vent holes) that facilitate breathability and stretch requirement.

3. Laminate die-cut thermoplastic layer 102 to base material fabric 101.

4. Laminate HydroGel conductive adhesive 108 to electrode areas of the conductive ink layer 103 on the thermoplastic layer 102.

5. Mask HydroGel layer 108.

6. Laminate tape adhesive layer 104 with release film layer 110 to thermoplastic side of base material fabric 101.

7. Die-cut assembly to final size.

[0104] EMBODIMENT 3 : AN ADHESIVE TAPE THAT INCORPORATES ELECTRODES FOR DELIVERING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION THERAPY AND ELECTRICAL MUSCLE STIMULATION THERAPY, TOGETHER WITH A HEATER FOR DELIVERING HEAT THERAPY, WHERE THE POWER SOURCE IS ATTACHED TO THE ADHESIVE TAPE.

[0105] The heated tape 300 is based upon an adhesive tape that incorporates the electrodes for delivering Transcutaneous Electrical Nerve Stimulation (TENS) therapy and Electrical Muscle Stimulation (EMS) therapy, together with a heater for delivering heat therapy, whose power source is attached to the adhesive tape.

[0106] With existing TENS and EMS therapy for pain management, a remote, battery- operated device delivers low-voltage electrical current through the skin via electrodes placed near the source of the pain. In TENS therapy, the electricity from the electrodes stimulates nerves in the affected area and sends signals to the brain that "scramble" normal pain perception. In EMS therapy, the electricity from the electrodes stimulates the muscles, causing the muscles to contract on command. [0107] Embedded within the tape are a pair of electrodes for delivering the TENS and EMS signals to the skin. Signals that are generated from a power pack/control (not shown) attached to the tape. Also embedded in the adhesive tape, along with the electrodes (conductive ink layer 223), is a resistance heater (conductive ink layer 203) for providing heat therapy, which shares the same power source that generates the TENS and EMS waveforms.

[0108] With the addition of heat therapy, the adhesive tape becomes the vehicle for delivering 3 therapeutic modalities. The heat warms the muscles for soothing comfort, TENS provides pain relief, while EMS stimulates blood flow and improves muscle strength and performance.

[0109] The construction of the electrodes and the resistance heater, embedded within the adhesive tape, is from stretchable and flexible conductive inks. The power circuits for the heater and electrodes are independent from one another and are produced from a stretchable and flexible conductive silver ink. The system, therefore, is preferably wireless.

[0110] The adhesive tape, with electrodes and resistance heater embedded is, in appearance and feel, preferably no different than adhesive tape without electrodes or a resistance heater. It is able to stretch, flex, contour and adhere to the skin in much the same way as any other adhesive tape.

[0111] Power is supplied to the tape via a rechargeable power pack/control that snaps directly on to the tape, eliminating the need to have a remote device with wires leading to electrodes on the body.

[0112] Existing TENS and EMS units are an ergonomic nightmare. They are awkward and cumbersome to use, being anything but user friendly. And, almost universally, none of them offer heat therapy.

[0113] EXISTING TENS/EMS UNITS VS THE INVENTION: [0114] The use of wires that are suspended between the controller and a pair of electrodes is routinely problematic. Constant attention is required to assure that no strain is applied to the electrode leads that would cause the electrodes to come free or the control to become dislodged and damaged. In order to administer conventional TENS and EMS therapy to most parts of the body it is necessary to remove clothing in order to accommodate the placement of electrodes and electrode wires, meaning that the user must be restricted to either a clinical setting or private home environment. And, generally, while undergoing therapy, the patient is unable to freely move about. A remote control that must be held by hand or safely placed in proximity to the electrode leads. If the patient moves, the control and its electrode leads must also move with the patient. The frequency of therapeutic sessions is also limited to those times when the patient is in a clinical setting or the privacy of their own home.

[0115] The unique construction of the adhesive tape 300 is such that, there are preferably no wires used to convey power to the resistance heater or to the electrodes. The electrodes are embedded within the adhesive tape and, as such, are integral with the adhesive tape and cannot come free from contact with the skin, unless the adhesive tape is intentionally removed. As no leads are required, the adhesive tape 300, with electrodes and heater embedded, may conveniently be worn beneath ones clothing for concealed therapy. No need to be in a clinical or private home environment, while allowing the patient to move about freely, without restriction. No remote controlling device is required, as control is accomplished via a rechargeable power pack (not shown, roughly the size of a pack of gum) that directly snaps onto the tape, once again, allowing the patient to move about at will. The features of the power pack may be accessed at the power pack or, remotely, via an app on your phone. The skin friendly adhesive tape 300 may be applied to the skin for as long as desired, be it a few hours or a few weeks. Once the adhesive tape 300 is in place, whether "powered up" or not, the user’s activities are not restricted.

Sleeping, bathing, and exercising with the adhesive tape in place has no negative effect on the tape. And, as long as the tape remains adhered to the skin, when one is feeling like a therapy session, he or she has can power up the heated tape 300, for practically an unlimited number of therapy sessions. [0116] By using an adhesive tape 300 as the vehicle for delivering TENS, EMS and heat therapy, the above problems are solved. Tape 300 will not only allow these interventions to be used more effectively, but will permit them to be accessed by many more people and, in doing so, will revolutionize the way these therapeutic modalities are administered.

[0117] In operation," powering up" the adhesive tape 300 may be accomplished via an app on a phone, or directly at the power pack. The user may then select the desired therapy, TENS, EMS or heat therapy, or a combination mode, that alternates back and forth between heat and TENS or EMS therapy.

[0118] Regardless of which mode is selected, a built in Auto Shutdown feature will cut power to the adhesive tape after a pre-set period of time, preventing the battery from inadvertently being discharged, should the patient fall asleep.

[0119] The power source utilizes a Lithium rechargeable battery, designed to be recharged in place, or conveniently removed and replaced with another power pack with fully charged batteries. The adhesive of the tape is such that, once removed, if stored properly, it may be re-used several times before being discarded, while the power pack is retained for use on the next adhesive strip. The skin friendly adhesive system of the adhesive tape is such that, it will not allow the tape to come free or irritate the skin.

[0120] SYSTEM COMPONENTS AND FEATURES

1. FABRIC BASE:

While the system is conducive for use with any fabric base, certain characteristics are preferred. See Figure 3 for an exemplary construction.

- A fabric base that is moisture wicking.

- A fabric base that is breathable.

- A fabric base that is conducive to heat sealing with thermoplastic film.

- A fabric base with water repellent characteristics.

- A fabric base that is stretchable, in one or two directions. - A fabric base that has Antibacterial properties.

2. TAPE ADHESIVE:

- Non-conductive.

- Skin friendly - tested for and meets the ISO 10993 standards for skin sensitization and irritation.

- Latex free

- Hypoallergenic

- Moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR).

- Breathable - for adhesive and skin stability.

- Stretchable - to accommodate the required characteristics of the adhesive tape.

- Repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

3. THE POWER PACK/CONTROL:

- Power Source: (2) 3.7 Volt, 330 mAh Li. Rechargeable Batteries.

- Battery Life: 2 hours continuous operation.

- Control: From device and wireless.

- Logic: Micro-controller.

- TENS Programs: 6

- TENS Pulse Width: 260 uS

- TENS Frequency: 0-60 Hz

- EMS Programs: 6

- EMS Pulse Width: 200 & 300 uS

- EMS Pulse Rate: Various, 4-99 Hz

- Specs for TENS and EMS: Based upon 500 Ohm load (- +/- 10%). - Pulse Intensity: Adjustable for both TENS and EMS.

- Modes: Heat only, TENS only, EMS only, Heat with TENS or EMS.

- Temp Range Adjustment: Downward only.

- Auto Shutdown.

- Energy Saving Circuitry.

- Recharging Circuit.

- Power Connection to Tape: Spring snaps.

- Battery Level Indication: LED

- Housing Construction: Ultra thin. Light weight. Molded from PE, with curved shape to accommodate body profile. Housing designed to level IP65. User interface, via a graphic display overlay with tactile feedback switch.

4. RESISTANCE HEATER:

- Volts: 7.4 V,

- Watts: 2.4 W

- Current: 330 mAh

- Design Temperature: 110 degrees F.

- Heater Material: Stretchable, flexible conductive carbon ink.

- Bus Bars: Stretchable, flexible conductive silver ink

- Control: From Positive Temperature Coefficient, self regulating carbon ink.

- Heater Design: Provides for a uniform, hot spot free, coverage throughout the design heating area. Specifically designed to not interfere with the breathability and stretch characteristics of the adhesive tape.

5. ELECTRODES:

- Material: Stretchable, flexible conductive carbon ink and Hydrogel.

- Bus Bars : Stretchable, flexible conductive silver ink 6. THERMOPLASTIC FILM:

- Required as a stretchable, flexible, breathable, ink drying temperature tolerant base on which to screen the power, heater and electrode circuitry inks.

7. CONSTRUCTION SEQUENCE:

Referring now to heated tape 300 of FIG. 3:

T Screen conductive inks for the resistance heater and its power circuitry, such as bus bars 207,217 onto thermoplastic layer 202.

2. Die-cut thermoplastic layer 202 for sizing and perforation.

3. Heat set thermoplastic layer 202 to adhesive side of base fabric layer 201.

4. Screen print conductive ink layers 203 and 223 for the heater, electrodes and related power circuitry onto separate thermoplastic layers 202 and 222, respectively.

5. Die-cut 2nd thermoplastic layer 222 for sizing and perforation.

6. Heat set 2nd thermoplastic layer 222 directly to first thermoplastic layer 202.

7. Laminate HydroGel layer 208 conductive adhesive to electrode areas of 2nd thermoplastic layer 223.

8. Add Mask layer 209 to HydroGel areas.

9. Laminate tape adhesive layer 204 with release film layer 210 to thermoplastic layer- side of base fabric 201.

10. Die-cut assembly to final size.

11. Apply power snaps (not shown) to adhesive tape final assembly.

[0121] EMBODIMENT 4: REUSABLE, SELF-POWERED, ELECTRICALLY HEATED, THERAPY SYSTEM [0122] The reusable heater product 400 of FIG. 4, preferably incorporates a reusable (or machine washable), self-powered, wireless, carbon ink, flexible and stretchable resistance heater onto a fabric layer 301 base, as a means for conveniently and economically being able to apply electrical heat therapy to any area of a human or animal body, for such applications as, chiropractic care, physical therapy, arthritis care, etc.

[0123] For kinesiology tape, the tape 400 can stretch anisotropically, up to 100-180% of its original unstretched length, preferably about 125-165% in the warp direction and only about 5-20%, preferably about 10% in the weft direction. For other applications, such as wraps or other kinds of tape, the fabric layer can have much less stretch, and can be closer to isotropic in stretchability, such as about 10-80% in the warp direction and about 10-80% in the weft direction. The heaters are preferably battery powered, such as by Li polymer rechargeable batteries (not shown).

[0124] By providing heat, we are providing a blood flow stimulant. When warming up, prior to work-out or exercise, increased blood flow to the muscles, bones and surrounding tissue can be of enormous benefit for the purpose of preventing injury. Additionally, stimulating blood flow is a modality for the purpose of providing pain relief and, in general, for advancing the healing of the body.

[0125] In the preferred embodiment of this invention, an elastic therapeutic wrap adapted for application to the external skin of a wearer is provided, comprising: an elongated elastic fibrous or fabric layer 301 sized to conform to a portion of the external skin of the body of said wearer; and a battery powered, portable heating element containing a conductive ink layer 303, preferably laminated or adhered between a pair of thermoplastic layers 302, 322, is joined to said elongated elastic fibrous or fabric layer 301 for delivering heat to at least said portion of the external skin. In more preferred embodiments, the battery powered, portable heating element comprises a flexible, stretchable, conductive carbon ink layer 303. And is still further embodiments, the flexible, stretchable, conductive carbon ink layer 303 is compounded to be self-regulating for temperature. In further embodiments, the power circuitry, such as the printed silver bus bars 307 can be produced from a stretchable, flexible conductive silver ink. The perforated seam in the fabric layer 301 aligns with the saw-tooth openings in the thermoplastic layers 302,322, and conductive ink layer 303, so that the tape 400 can be tom into a preferred “Y” configuration of various proportions, depending upon how much of the seam is tom.

[0126] SYSTEM COMPONENTS ACCORDING TO ONE EMBODIMENT

1. BASE FABRIC CHARACTERISTICS:

- A stretchable, flexible fabric that will contour well to the body.

- Moisture wicking.

- Insulating.

- Breathable.

- Heat setting compatibility with thermoplastic film.

- Water repellent.

-Potentially Split-able - one end of the heater/tape combination can be split (as by hand-tom perforations or by scissors or the like) to provide a “Y” or “X” shape from an “I” shape, with each leg of the “Y” or “X” having a portion of the heating element on it, preferably powered by the same power supply, and more preferably, the heater and tape have a “Y” or “X” shaped heating element on it, in which the end or ends of the “I” shape can be separated to reveal a “Y” or an “X” shape for wholly or partially wrapping around a body part. See Figures 5 and 7, for example.

2. PREFERRED RESISTANCE HEATER SPECIFICATIONS (all values +/- 15%, preferably +/- 10%):

- Input Voltage: 7.4 volts

- Watts: 2.8 watts.

- Current Draw: 378 ma

- Design Operating Temperature: about 100-110 F, preferably self-regulating so that the electrical resistance increases with temperature until the heater cannot effectively heat any further, or more preferably the heater ink has positive temperature coefficient (PTC) properties focused in and around the Design Operating Temperature.

- Duty Cycle: Continuous.

- Heating Element Composition: Custom compounded, flexible, stretchable, conductive carbon ink.

- Bus Bars: Stretchable, flexible, conductive silver or copper ink.

- Thermoplastic Film: Provides for a stretchable, flexible, breathable, ink drying temperature tolerant, stable base on which to screen and protect the conductive inks.

- Heater Design: A pattern of carbon ink that provides for a uniform, hot spot free, heat coverage of the design heating area, that can also accommodate the stretch and ventilation characteristics of the therapy system.

3. TEMPERATURE CONTROL: Via Positive Temperature Coefficient self- regulating carbon ink. Self-regulating meaning that, as the temperature increases and decreases, the resistance of the ink increases and decreases, respectively, effectively turning the power, up or down, or on and off, or both, in order to maintain the system design temperature.

4. POWER SOURCE: (2) 3.7 volt, 400 mAh, Lithium Polymer rechargeable batteries with protection circuitry. Battery capacity to provide 90-120 minutes of heater operation at full power. 5. POWER PACK DESIGN AND FEATURES : Ultra-thin. Lightweight. Power is delivered to preferred spring type metal snaps at rear of the power pack (not shown), that provide for a positive electrical connection, but require minimal effort to snap and unsnap. A housing can be provided which is sized to accommodate (2) flexible, flat Lithium Polymer batteries, a PCB assembly incorporating a lighted On/Off switch, battery level indication by LED, auto shutdown feature, heat reduction option, energy saving circuitry and charging port, or any combination of these features. It desirably is housed in a plastic case designed to level IP65. User interface can be provided, via a graphic display overlay with tactile feedback switch. The power pack may be removed prior to washing.

6. A PREFERRED CONSTRUCTION SEQUENCE:

See non-adhesive heater 400 of Figure 4 for an exemplary construction.

1. Screen conductive ink layer 303 and conductive ink bus bar 307 for power and resistance heater circuitry onto thermoplastic layer 302.

2. Die-cut thermoplastic layer 302 for sizing and relief of the thermoplastic urethane to facilitate system breathability and stretch requirements.

3. Heat set die-cut thermoplastic layer 302 to fabric layer 301 base.

4. Die-cut 2 ^nd thermoplastic layer 322, which can be use for the protection of heater circuitry from ware and moisture.

5. Heat set 2 ^nd die-cut thermoplastic layer 322 to the 1st thermoplastic layer 302, which encapsulates the conductive ink layer 303 and bus bar 307.

6. Screen graphics on non-heater side of fabric layer 301 base.

7. Die-cut assembly to final size.

8. Secure snaps at power end.

[0127] EMBODIMENT 5 : SELF-POWERED, ELECTRICALLY HEATED,

ADHESIVE TAPE [0128] A further embodiment of a self-powered electrically heated adhesive tape 500, shown in FIG. 5, is based upon incorporating a wireless, carbon ink, flexible and stretchable resistance heater into an adhesive tape, whose power source is attached, as a means for conveniently and economically being able to apply electrical resistance heat therapy to any area of the body. The heated therapy system utilizes an adhesive layer 604 to secure the system to the body, for such applications as, chiropractic care, physical therapy, arthritis care, etc. For kinesiology tape, the tape can stretch anisotropically, up to 100%- 180%, preferably about 125%- 165% in the warp direction and only about 5-20%, preferably about 10% in the weft direction. For other applications, the tape 500, can have much less stretch, and can be closer to isotropic in stretchability, such as about 10-80% in the warp direction and about 10-80% in the weft direction. The heaters are preferably battery powered, such as by Li polymer rechargeable batteries.

[0129] By providing heat, we are providing a blood flow stimulant. When warming up, prior to work-out or exercise, increased blood flow to the muscles, bones and surrounding tissue can be of enormous benefit for the purpose of preventing injury. Additionally, stimulating blood flow is one modality for the purpose of providing pain relief and, in general, for advancing the healing of the body.

[0130] In the preferred embodiment of this invention, an elastic therapeutic tape 500 adapted for adhesive application to the external skin of a wearer is provided, comprising: an elongated fibrous layer sized to conform to a portion of the external skin of the body of said wearer to provide for a gentle lifting force to the external skin portion when adhered thereon; a pressure sensitive adhesive layer disposed on a surface of said elongated fabric layer 601 ; and a battery powered, portable heating element joined to said elongated fabric layer 601 for delivering heat to at least said portion of the external skin. In more preferred embodiments, the battery powered, portable heating element comprises a flexible, stretchable, conductive carbon ink layer 603. And is still further embodiments, the flexible, stretchable, conductive carbon ink layer is compounded to be self-regulating for temperature. In further embodiments, the power circuitry, such as the printed silver bus bars can be produced from a stretchable, flexible conductive silver ink. 1 SYSTEM COMPONENTS ACCORDING TO ONE EMBODIMENT

BASE FABRIC CHARACTERISTICS:

- A stretchable, flexible fabric that will contour well to the body.

- Moisture wicking.

- Insulating.

- Breathable.

- Heat setting compatibility with thermoplastic film.

- Water repellent.

2. RESISTANCE HEATER SPECIFICATIONS (all values +/- 15%, preferably +/-

10%):

- Input Voltage: 7.4 volts

- Watts: 2.8 watts.

- Current Draw: 378 ma

- Design Operating Temperature: about 100-110 F, preferably self-regulating so that the electrical resistance increases with temperature until the heater cannot effectively heat any further, or more preferably the heater ink has positive temperature coefficient (PTC) properties focused in and around the Design Operating Temperature.

- Duty Cycle: Continuous.

- Heating Element Composition: Custom compounded, flexible, stretchable, conductive carbon ink.

- Bus Bars: Stretchable, flexible, conductive silver or copper ink.

- Thermoplastic Film: Provides for a stretchable, flexible, breathable, ink drying temperature tolerant, stable base on which to screen and protect the conductive inks. - Heater Design: A pattern of carbon ink that provides for a uniform, hot spot free, heat coverage of the design heating area that can also accommodate the stretch and ventilation characteristics of the therapy system.

3. TEMPERATURE CONTROL: Via Positive Temperature Coefficient self- regulating carbon ink. Self-regulating meaning that, as the temperature increases and decreases, the resistance of the ink increases and decreases, respectively, effectively turning the power, up or down, or on and off, or both, in order to maintain the system design temperature.

4. POWER SOURCE: (2) 3.7 volt, 400mAh, Lithium Polymer rechargeable batteries with protection circuitry. Battery capacity to provide 90-120 minutes of heater operation at full power.

5. POWER PACK DESIGN AND FEATURES : Ultra-thin. Lightweight. Power is delivered to preferred spring type metal snaps at rear of the power pack that provide for a positive electrical connection, but require minimal effort to snap and unsnap. A housing can be provided which is sized to accommodate (2) flexible, flat Lithium Polymer batteries, a PCB assembly incorporating a lighted On/Off switch, battery level indication by LED, auto shutdown feature, heat reduction option, energy saving circuitry and charging port, or any combination of these features. It desirably is housed in a plastic case with curved profile to accommodate body contour. Housing can be designed to level IP65. User interface, can be provided via a graphic display overlay with tactile feedback switch.

6. PREFERRED ADHESIVE FEATURES :

- Skin friendly - tested for and meets the ISO 10993 standards for skin sensitization and irritation.

- Latex free

- Hypoallergenic

- Moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR).

- Breathable - for adhesive and skin stability.

- Stretchable - to accommodate the elastic characteristics of the adhesive tape. - Repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

- Potentially Split-able - one end of the heater/tape combination can be split (as by hand- torn perforations or by scissors or the like) to provide a “Y” or “X” shape from an “I” shape, with each leg of the “Y” or “X” having a portion of the heating element on it, preferably powered by the same power supply, and more preferably, the heater and tape have a “Y” or “X” shaped heating element on it, in which the end or ends of the “I” shape can be separated to reveal a “Y” or an “X” shape for wholly or partially wrapping around a body part. See Figures 5, 7 and 9, for example, which show a seam, like perforated seam 621, which allows selective separation of the top and bottom sections to form a “Y”, a pair of perforated seams from each transverse end can accommodate an “X” configuration.

7. A PREFERRED CONSTRUCTION SEQUENCE:

See heater 500 of Figure 5 for an exemplary construction.

1. Screen conductive ink layer 603 and bus bars for power and resistance heater circuitry onto thermoplastic layer 602.

2. Die-cut thermoplastic layer 602 for sizing and relief of the preferred thermoplastic urethane to facilitate system breathability and stretch requirements.

3. Heat set die-cut thermoplastic layer 602 to fabric layer 601 base.

4. Laminate adhesive layer 604 and its release liner layer 610 to heater side of fabric layer 601 base.

5. Screen graphics on non-heater side of fabric layer 601 base.

6. Die-cut assembly to final size.

7. Secure snaps at power end, not shown. Add power pack, also not shown.

[0131] EMBODIMENT 6: TRANSDERMAL DELIVERY SYSTEM UTILIZING A SELF-POWERED, ELECTRICALLY HEATED, ADHESIVE TAPE [0132] The invention is based upon incorporating a wireless, carbon ink, flexible and stretchable resistance heater into an adhesive tape, whose power source is attached, as a means for conveniently and economically being able to apply electrical heat to any area of the body as described above in connection with heated tape 500, FIG. 5, but by adding a medicine to the adhesive or proximate to the adhesive, for the purpose of facilitating the transdermal delivery of active ingredients through the skin for systemic distribution. Alternatively the transdermal delivery system utilizes a target heater 600, FIG. 6-8, which may include an adhesive layer 33 or tabs 30 to secure the system to the body. Compounded within or near the adhesive are the active ingredients that are to be released through the skin for systemic distribution.

[0133] Transdermal and Topical Actives

[0134] Pharmaceutical actives useful in the present invention include any chemical material or compound suitable for transdermal or topical administration; however, such drugs should avoid interfering with the stability of the adhesive composition, if added thereto. Such substances include, but are not limited to antibiotics, wound healing agents, vasodilators, coagulants, birth control drugs, cardiovascular drugs, chemotherapeutic agents, vitamins, antiviral agents, anti-microbial agents, analgesics, anti-inflammatory agents, such as steroidal agents, such as hydrocortisone and triamcinolone, or non-steroidal agents, such as ibuprofen, naproxen, flufenamic acid, mefenamic acid, meclofenamic acid, prioxicam and felbinac. Transdermal decongestants and antihistamines are also available, such as diphenhydramine and triprolidine transdermal antihistamine, available from Proctor and Gamble Co., Inc., Cincinnati, Ohio; others include ephedrine (which can also be an aromatic), dimethindene, epinastine, emedastine, and clonidine. In addition, cannabis oils can be added, such as cannabidiol, or (CBD oil). Transdermal substances can be delivered in a number of known manners.

[0135] Useful anesthetic or antipruritic drugs are selected from the group consisting of lidocaine, lidocaine hydro-chloride, bupivacaine hydrochloride, chloroprocaine hydrochloride, dibucaine hydrochloride, etidocaine hydrochloride, mepivacaine hydrochloride, tetracaine, tetracaine hydrochloride, dyclonine hydrochloride and hexylcaine hydrochloride, benzocaine, benzyl alcohol, butamben picrate, camphor (also an aromatic active), camphorated metacresol, dibucaine, dibucaine hydrochloride, dimethisoquin hydrochloride, diphenhydramine hydrochloride, juniper tar, menthol (also an aromatic medication), phenol, phenolate sodium, promazine hydrochloride, resorcinol and mixtures thereof.

[0136] Various vitamins may also be included in the topical compositions of the present invention. For example, Vitamin A, and derivatives thereof, ascorbic acid, Vitamin B, biotin, pantothenic acid, Vitamin D, and mixtures thereof may be used. Vitamin E, tocopherol acetate and derivatives may also be used.

[0137] These topical and transdermal substances and medications can be added to the elongated fibrous layer, added to an intermediate layer, or mixed within adhesive layers , as in, for example, in films, microcapsules or in a dispersion-type transdermal patch formulation made from acrylate copolymer adhesive, a lecithin gel based matrix, or a polyurethane acrylic copolymer, such as disclosed in U.S. Pat. No. 4,638,043 to Szycher et al., which is hereby incorporated by reference. Alternatively, a rate controlling membrane could be used, such as Eudragit RL-100.

[0138] Heat can enhance the transdermal delivery of various drugs by increasing skin permeability, body circulation, blood vessel wall permeability, rate limiting membrane permeability and drug solubility. Heating prior to or during topical application of a drug will dilate penetration pathways in the skin, increase kinetic energy and the movement of particles in the treated area and facilitate drug absorption. Heating the skin after topical application of a drug will increase the drug absorption into the vascular network, enhancing the systemic delivery but decreasing the local delivery as the drug molecule is carried away from the local site. Evidence suggests that a temperature change of 5 degrees C is necessary to cause measurable changes in cell permeability. The temperature can be controlled to within +/- 1 F for certain actives, in order to control dosing. The temperature of the heater can be controlled to release certain actives which are not usually transmitted to the bloodstream using conventional non-heated, adhesive based transdermal delivery systems.

[0139] The unique construction of the present target heater 600 with transdermal delivery embedded within an adhesive layers 32, adhesive layer(s) 33 and/or adhesive tabs 30, is such that there preferably are no wires or conductive metal yarns used to convey power or used to form the heating element. It is desirably a 100% wireless system. Likewise, the use of external temperature controlling device can be eliminated, as temperature control is preferably accomplished via a self-regulating carbon based ink.

[0140] In one embodiment, the transdermal target heater 600 is preferably, in appearance and feel, no different than adhesive patch without a resistance heater. The system is able to flex, stretch and contour and adhere to the skin in substantially the same way as unheated adhesive tape.

[0141] Power is preferably supplied via a low voltage power pack 25, FIG. 8, that snaps onto studs 20 exposed on the back of the target heater 600. The power pack 25 may be rechargeable. Control of the power pack may be accessed directly at the power pack or remotely, via wireless control from a software application (“app”) on a mobile phone. Once powered up, the transdermal heater tape will bring the temperature up to the desired temperature, for example, 100-110 degrees F, for a desired time, for example, 15-60 minutes, more preferably up to about 30 minutes. Alternatively, optional temperature settings and heating cycles may be accessed and chosen for the delivery of the active ingredients, embedded within, on the surface of the adhesive.

[0142] The target heater 600 mayor may not utilize an adhesive layer 33 backing to secure the system to the body. Its ability to stay in place during therapy can rely on it being mechanically secured to the body. (This securement can be made with replaceable and removable adhesive pads 30, shown for the target heater 100 of FIGS. 6-8, which can be applied to the underside of the fabric layer 12 or thermoplastic layer 18 and then adhered to the skin of a wearer, an adhesive tape applied over the system and then to the wear’s skin (not shown), elastic or mechanical straps, hook and loop materials, compression wear or some other mechanical means.

[0143] In certain other embodiments, the adhesive tabs 30 or pads can include a transdermal active, or the adhesive tabs 30 can be substituted with adhesively applied hook and loop fastener pads (one of which can be applied to the skin of the wearer and may also contain an optional transdermal active).

[0144] In still further embodiments, an adhesive layer 33 or film can include a transdermal active and/or transdermal delivery system, while the adhesive layers 32 or patches could be an un-medicated, hypoallergenic adhesive, like acrylate adhesive, or both adhesive applications 32 and 33 could have a transdermal active. [0145] In one embodiment, a fabric layer 12 is provided with a neoprene layer sandwiched between a pair of nylon fabric layers. In another embodiment, the fibrous or fabric layer 12 is a neoprene layer (or other stretchable fabric) sandwiched between a nylon fabric top layer and a bottom unbroken loop (UBL) fabric layer, which is then selectively applied to replaceable adhesive pads on the wearer’s skin, which have hook fasteners (e.g. Velcro hooks) on their exposed top surface, so that the UBL fabric on the underside of the fabric layer 12 can be reversibly adhered. It can also be useful to locate the UBL fabric on the replaceable adhesive pads, while providing the bottom surface of the neoprene layer with a hook fastener layer.

[0146] In one embodiment of a target heater 600, shown in FIGS. 6, 7, and 8, a pair of metallic snaps or studs 20, used to mechanically connect the heater 600 to a power pack 25, are also the means by which power is transferred between the power pack 25 and the heater, preferably a printed ink layer 16. An on/off switch, incorporated into the power pack 25, enables the wearer to "power up" the heated therapy system, heating it to a desired temperature, for example, 100-110 degrees F, for a desired time, for example 15-60 minutes, more preferably up to about 5-30 minutes, before automatically powering off. A power pack feature can provide the user with an option to choose a lower temperature setting, shorter or longer duration or periodic heating for certain time intervals, or pulse heating or pulse TENS or EMS electrical stimulations (through optional electrodes 55, see also tape 300 for electrical specifics), depending upon the circuitry. The target heater in this embodiment is round, and further includes a printed ink heater 16, laminated between a pair of TPU layers 14 and 18. The top TPU layer 14 is then bonded, preferably by heat, to the stretchable fabric layer 12. The battery power pack 25 is snapped onto the top end of the studs 20, which are about .12 inches in diameter, each, and spaced about .75 inches apart. The target heater 600 has a length of about 4.5 inches, a width of about 2.53 inches and heater area diameter of about 3 inches, or slightly wider than the width of the stretchable fabric layer 12. The power pack 25 can be made of a flexible material such as synthetic rubber or flexible, low density, polyethylene, and also preferably has a curved or concave shaped side facing the wearer to increase comfort and flexibility when applied to a limb. The buttons on the top face of the power pack can include an on/off button and one or more heater settings buttons. [0147] Since the target heater 600 may not rely on a one-time use adhesive layer 33 to hold it in place, it may be reused, over and over again. The system is preferably machine or hand washable, without damage to the heater or its circuitry, making it hygienically practical for continued reuse.

[0148] And, because it is preferably self-powered, and preferably not utilizing remote wires for its power, it may be worn seamlessly for extended periods of time, allowing the user to go about daily activities, only "powering up" when a therapy session is desired. The ergonomically friendly heated therapy system may be worn underneath clothing, or adhesively attached to clothing, for concealed pain relief therapy.

[0149] The construction of the resistance heater in the first embodiment is such that, there preferably are no wires or conductive metal yarns used to convey power or used to form the heating element. It can be a wireless system. Likewise, no external temperature-controlling device may be required, as temperature control can be accomplished via a self-regulating carbon based ink.

[0150] Precut strips make the preferred heated kinesiology taping faster and more convenient by eliminating the need to use scissors to cut rolls of tape. Because they are machine cut with rounded comers, precut strips have less fraying than kinesiology tape cut with scissors.

1. SYSTEM COMPONENTS ACCORDING TO ONE EMBODIMENT

BASE FABRIC CHARACTERISTICS:

- A stretchable, flexible fabric that will contour well to the body.

- Moisture wicking.

- Insulating.

- Breathable.

- Heat setting compatibility with thermoplastic film.

- Water repellent. 2. RESISTANCE HEATER SPECIFICATIONS (all values +/- 15%, and preferably +/- 10%):

- Input Voltage: 7.4 volts

- Watts: 2.8 watts.

- Current Draw: 378 ma

- Design Operating Temperature: about 100-110 F, preferably self-regulating so that the electrical resistance increases with temperature until the heater cannot effectively heat any further, or more preferably the heater ink has positive temperature coefficient (PTC) properties focused in and around the Design Operating Temperature.

- Duty Cycle: Continuous.

- Heating Element Composition: Custom compounded, flexible, stretchable, conductive carbon ink.

- Bus Bars: Stretchable, flexible, conductive silver or copper ink.

- Thermoplastic Film: Provides for a stretchable, flexible, breathable, ink drying temperature tolerant, stable base on which to screen and protect the conductive inks.

- Heater Design: A pattern of carbon ink that provides for a uniform, hot spot free, heat coverage of the design heating area that can also accommodate the stretch and ventilation characteristics of the delivery system.

3. TEMPERATURE CONTROL: Via Positive Temperature Coefficient self- regulating carbon ink. Self-regulating meaning that, as the temperature increases and decreases, the resistance of the ink increases and decreases, respectively, effectively turning the power, up or down, on and off, or both, in order to maintain the system design temperature.

4. POWER SOURCE: (2) 3.7 volt, 400mAh, Lithium Polymer rechargeable batteries with protection circuitry. Battery capacity to provide 60 plus minutes of heater operation at full power.

5. POWER PACK DESIGN AND FEATURES : Ultra-thin. Lightweight. Power is delivered to preferred spring type metal snaps at rear of the power pack 25 that provide for a positive electrical connection when connected to the mating snaps on the adhesive tape, but require minimal effort to snap and unsnap. A housing can be provided which is sized to accommodate a charging port, (2) flat Lithium Polymer batteries, a PCB assembly incorporating the power and connection snaps, a lighted On/Off switch, battery level indication by LED, logic to facilitate the auto shutdown, optional temperature and timing settings and energy saving circuitry features, or any combination of these features. It is desirably housed in a plastic case with radiused profile to accommodate body contour. Housing can be designed to level IP65. User interface can be provided via a graphic display overlay with tactile feedback switch.

6. ADHESIVE FEATURES OF A PREFERRED EMBODIMENT:

- Makes excellent (intimate) contact with the skin at macroscopic and microscopic levels.

- Skin friendly - tested for and desirably meets the ISO 10993 standards for skin sensitization and irritation.

- Provides for aggressive adhesion during dosing without being disturbed by activities such as bathing, exercising, etc.

- Easily removed from skin without leaving an adhesive residue.

- Latex free

- Hypoallergenic

- Moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR).

- Breathable - for adhesive and skin stability.

- Stretchable - to accommodate the elastic characteristics of the adhesive tape (such as Kinesiology tape).

- Repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

- Potentially Split-able - one end of the heater/tape combination can be split (as by hand- torn perforations or by scissors or the like) to provide a “Y” or “X” shape from an “I” shape, with each leg of the “Y” or “X” having a portion of the heating element on it, preferably powered by the same power supply, and more preferably, the heater and tape have a “ Y” or “X” shaped heating element on it, in which the end or ends of the “I” shape can be separated to reveal a “Y” or an “X” shape for wholly or partially wrapping around a body part.

7. CONSTRUCTION SEQUENCE OF A PREFERRED EMBODIMENT:

Referring to target heater 600 of FIGS. 6, 7, and 8:

1. Screen conductive inks 16 for power and resistance heater circuitry onto thermoplastic layer 14.

2. Die-cut thermoplastic layer 14 for sizing and relief of the thermoplastic urethane to facilitate system breathability and stretch requirements. Add optional adhesive layers 32 or patches 30.

3. Heat set die-cut thermoplastic layer 14 to fabric layer 12 base.

4. Laminate second thermoplastic layer 18 with adhesive layer 33 containing transdermal actives to heater side of fabric layer 12.

5. Screen graphics on non-heater side of fabric base.

6. Die-cut assembly to final size.

7. Secure studs 20 for snaps at power end.

[0151] EMBODIMENT 7: TRANSDERMAL DELIVERY OF CANNABIDIOL UTILIZING THERAPEUTIC ELASTIC TAPE

[0152] The therapeutic elastic adhesive tape of this invention is useful for such applications as, chiropractic care, physical therapy, arthritis care, etc. For transdermal delivery systems (TDDS) disposed on kinesiology tape, the tape can stretch anisotropically, up to 100%- 180%, preferably about 125%-165% in the warp direction and only about 5-20%, preferably about 10% in the weft direction. For other applications, the tape can have much less stretch, and can be closer to isotropic in stretchability, such as about 10-80% in the warp direction and about 10-80% in the weft direction, and more preferably about 5-20% in the warp direction and about 5-20% in the weft direction. [0153] Currently there are three prevalent types of pressure-sensitive bioadhesives (PSA) in use in the U.S. TDDS market: polyacrylate copolymers (acrylics), polysiloxanes (silicones) and polyisobutylenes (PIBs). See https://www.adhesivesmag.com/articles/86012-adhesives-in- transdermal-drug-delivery-systems.

[0154] Each of these types of adhesive can be modified according to the cannabinoid drug being administered, the length of application time desired and dosage strength. Two adhesive companies that do supply the TDDS market with ready-to-use PSAs are Adhesives Research Inc. and MACtac. Major manufacturers of pharmaceutical grade acrylic PSAs include the National Starch and Chemical Company and Adhesives Research, Inc.

[0155] Currently, there are two main types of TDDS structures: drug-in-adhesive (DIA) and reservoir. These two types of TDDS also have their own variations, creating multiple potential TDDS structures.

[0156] DIA systems are the easiest to manufacture because all of their components are combined. They are, however, the most complicated for adhesive manufacturers because the addition of the drug and possibly chemical-permeation enhancers is likely to affect the potency of the adhesive, and vice versa.

[0157] DIA systems are available in monolithic or multilaminate structures. Monolithic TDDS structures contain only one layer of drug-adhesive solution between the patch backing and the patch lining. Multilaminate structures contain both a drug-adhesive layer and an adhesive- only layer. A membrane that controls the release rate of the drug separates these two layers.

[0158] Reservoir systems keep the drug and adhesive separated by one of two methods.

In the basic liquid reservoir system, a membrane separates the drug/permeation enhancer combination from the adhesive. The membrane usually acts as a method of controlling the drug flow. In liquid reservoir systems, the drug must pass through the adhesive layer, so precautions must be taken to ensure that the drug and adhesive do not react with each other. [0159] A variation of the liquid reservoir system is the polymer matrix system. In this design, the adhesive surrounds the periphery of the patch and therefore does not come into contact with the drug. With these types of patches, only the adhesives' adhesive properties and skin compatibility are a concern.

[0160] Cannabinoids are found exclusively in the cannabis plant (indica, sativa, and ruderalis) and are responsible for the myriad of psychedelic and medicinal effects. Common cannabinoids include: CBG, CBN, CBD, THCA, and THCV.

[0161] Cannabidiol, known as CBD, is a non-psychoactive cannabinoid with therapeutic potential for treatment of neuropathic pain, cancer pain arthritis pain, multiple sclerosis, inflammation and, in general for managing chronic pain. In addition, studies show that CBD oil has a high potential for treating skin conditions like eczema by encouraging abnormal cell death. It can also help regulate the skin's oil production, reducing acne. CBD also contains many nutrients like vitamin E that help improve and protect the skin.

[0162] CBD oil is especially promising due to its lack of intoxicating effects and a possible lower potential for side effects than many other pain medications.

[0163] It is the second most prevalent of the active ingredients of cannabis (marijuana). While CBD is an essential component of medical marijuana, it is derived directly from the hemp plant, which is a cousin of the marijuana plant. There are different levels of compounds found in the natural hemp or cannabis plant. How people breed the plant affects the CBD levels. Most CBD oil comes from industrial hemp, which usually has a higher CBD content than marijuana. Makers of CBD oil use different methods to extract the compound. The extract is then added to a carrier oil and called CBD oil. CBD oil comes in many different strengths, and people use it in various ways. [0164] The invention is based upon utilizing a cannabinoid -in-adhesive transdermal system that relates to the compounding of one or more cannabinoids directly within the skin contacting adhesive of the Therapeutic Elastic Adhesive Tape, such as kinesiology tape. In a preferred embodiment, a cannabidoid-containing adhesive patch in joined to an elastic tape, so that the cannabinoid does reach the bloodstream, when the tape is applied and can circulate throughout your entire body.

[0165] Transdermal drug delivery systems (TDDS) are the topically administered medications in self-contained, discrete dosage forms of patches which when applied to the skin deliver the drug, through the skin portal to systemic circulation at a predetermined and controlled rate over a prolonged period of time in order to increase the therapeutic efficacy and reduced side effect of drug. The ideal characteristics of a transdermal drug delivery system to TDDS include low molecular weight, lipophilicity, high potency, and reliable tape adhesion. The cannabinoid’ s solubility in the adhesive, its diffusion coefficient, and its permeability coefficient also play major roles in the time to steady-state release into the skin. Release rates of the cannabinoid are dependent on the concentration used. The adhesive uses a carrier substance that enables the cannabinoids to transfer more easily from the skin into the bloodstream. Because of its simplicity and patient preference, Drug-In-Adhesive systems (DIA), or in this case a cannabinoid -In- Adhesive system, is considered state-of-the art in transdermal drug delivery systems design. Cannabinoid -In-Adhesive delivery bypasses the digestive process for undiluted absorption of cannabinoids directly into the bloodstream, resulting in fast-acting effects with constant long term relief.

[0166] The transdermal delivery tape 700 of FIG. 9, when compared to the non-elastic cannabinoid -in-adhesive patches currently on the market, takes advantage of the opportunity to incorporate a cannabinoid -in-adhesive delivery system with Therapeutic Elastic Adhesive Tape, providing for a powerful combination of two well-known pain relieving modalities in one product. The cannabinoid -in-adhesive system is able to capitalize on the Kinesiology effect associated with Therapeutic Elastic Adhesive Tape in order to provide enhanced delivery of cannabinoid for faster acting affect. [0167] The effect of stretching the human Stratum Corneum (skin) increases the skins permeability and thus the rate of its transport of active ingredients through the skin. The routine application of Therapeutic Elastic Adhesive Tape requires that it is applied with stretch. When done so, the tapes effort to recoil, while adhered to the skin, leaves the skin in a continuous stretch condition, a condition that enhances the skins permeability.

[0168] Additionally, the tapes effort to recoil, creates a lifting effect on the skin, relieving the pressure on the underlying (subcutaneous) layers, allowing fluid to flow more easily to the area (increased circulation), translating into an increased absorption rate of cannabinoid into the bloodstream for systemic distribution.

1. SYSTEM COMPONENTS

TAPE FABRIC:

- Woven or non- woven

- Stretchable: unidirectional bi-directional or universally directional.

- Moisture wicking.

- Insulating.

- Breathable.

- Compatible for laminating or coating with adhesive.

- Water repellent.

2. FEATURES OF CANNABINOID-IN-ADHESIVE COMPOUND:

- Strong functional adhesive properties.

- Good biocompatibility with the skin.

- Chemical compatibility with cannabinoid.

- Chemical compatibility with various components of the formulation.

- Provide consistent, effective, delivery of the cannabinoid.

- Provide intimate contact with the skin at macroscopic and microscopic levels. - Meet ISO 10993 standards for skin sensitization and irritation.

- Provides for aggressive adhesion during dosing without being disturbed by activities such as bathing, exercising, etc.

- Easily removed from skin without leaving an adhesive residue.

- Latex free

- Hypoallergenic

- Moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR).

- Breathable - for adhesive and skin stability.

- Stretchable - to accommodate the elastic characteristics of the Therapeutic Elastic Adhesive Tape.

- Repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

3. CONSTRUCTION SEQUENCE:

See Figure 9, tape 700, for an exemplary construction.

1. Compounding of cannabinoid-in-adhesive solution.

2. Coating of release liner 810 with cannabinoid-in-adhesive solution 824 to form an adhesive layer with cannabinoid.

3. Laminating of fabric layer 801 to the coated release liner 824, 810.

4. Heat curing of laminated master roll.

5. Slitting of master roll.

6. Die-cutting and screen printing of slit rolls.

7. Rewinding of slit and die-cut material into finish rolls.

8. Packaging.

[0169] EMBODIMENT 8: A SELF COOLING, COLD TEMPERATURE, THERAPEUTIC ELASTIC ADHESIVE TAPE AND WRAP [0170] This embodiment conveniently and economically applies cold therapy to any surface area of the body. The cold therapy system utilizes a therapeutic elastic tape 800 in FIG.

10 with an adhesive, or other fastener, to secure the system directly to the body or onto one's clothing. Integral within the tape is an endothermic system that, upon activation, causes the tape to become cold.

[0171] An endothermic reaction is a reaction that absorbs energy from its environment, usually in the form of heat. It may be a chemical process, such as dissolving urea in water, or a physical process, such as the melting of ice cubes. The absorbed energy provides the activation energy for the reaction to occur. A constant input of energy, often in the form of heat, is needed to keep an endothermic reaction going. A hallmark of this type of reaction is that it feels cold.

[0172] It is important to apply ice or cold temperature to injured tissues, especially during the initial, or acute, phase of an injury. The application of cold temperature helps to decrease pain, lower tissue temperature and decrease swelling around the site of injury. Controlling inflammation with cold temperature and compression early after injury helps to maintain appropriate range of motion and mobility around an injured body part.

[0173] There are many ways to apply cold temperature to the body. Store bought ice bags and cold packs are most common. Another product, Ice Tape, is a flexible bandage that is infused with a cooling gel. When Ice Tape is exposed to air and applied to an injured body part, the gel feels cold against the skin. While the cooling gel provides cold sensation it does not provide actual cold temperature. It is infused into a flexible, self-adhering (to itself) wrap, is has a strong odor, strange texture, and tends to stick to skin and clothing. As such, it can only be applied as a wrap and will not adhere to the skin. While marginally good for immediate pain relief and inflammation control, it does not get cold enough when used right from the package at room temperature to adequately control inflammation. [0174] The embodiment described herein is based upon incorporating endothermic cooling materials (such as urea layer 926 and water layer 923, for example TPU layer 902 and upper tearable TPU layer 924 for water layer 923, and TPU layer 927 and lower tearable TPU layer 925 for urea layer 926), that are enclosed within separate, hermetically sealed, TPU film envelopes. One of which is laminated to an upper layer of elastic fabric layer 901, while the other is laminated to a lower layer of elastic fabric layer 911. The two envelopes are separated by a friable or tearable air/liquid impermeable TPU layers 925,924 that act as a common wall between the envelopes. Figure 10 shows one embodiment of the cooling tape 800.

[0175] The lower TPU laminated fabric layer 911, 927 is coated on its underside with an adhesive layer 904 that, when not applied to the body, is protected by a paper or polyester film adhesive liner 910. Once the adhesive liner 910 has been removed, the endothermic reaction is activated by stretching the entire elastic cooling tape 800. Doing so will cause a breaking or tearing of the separation layer(s) within the envelope(s), causing the previously separated components to mix together, creating an endothermic reaction. The tape 800 or wrap can then be applied, with appropriate stretch, directly to the body.

[0176] The unique construction of the endothermically cooled elastic adhesive tape 800 is such that, because it is preferably elastic, it is able to stretch, flex and contour to the skin, allowing the tape and the cold generated within the tape, to remain against or near the skin as the body moves. The endothermic system, being enclosed and partially insulated on the top side (non-skin side) by a layer of fabric that has been laminated on its underside — with for example, a microthin stretchable and breathable TPU material, such as a blend of nylon and polyester fabric or other material — in order to minimize temperature loss to the atmosphere, or reflect the cold temperature either radiantly or conductively back to the wearer.

[0177] Additionally, the endothermic material can be layered on the underside of the reactive material by another fabric layer 911 and optional TPU layer 928 that is designed to protect the skin from any potential for adverse effects of the endothermic reaction. This lower fabric layer 911 preferably conducts cold and also spreads the cold temperature more uniformly. The upper and lower fabric layers 901, 911 should have stretch properties to provide for flexible and drapeable bandages and tape, for example, kinesiology tape and ace bandage type wraps.

For example, in some embodiments, the adhesive tape can have elasticity of at least 10-30%. In some embodiments, the adhesive tape can have elasticity of up to 80%. In some embodiments, the adhesive tape can have elasticity of about 65%.

[0178] Because the cold temperature is preferably generated utilizing an endothermic compound, the adhesive tape does not need wires or conductive metal yarns used to convey power or used to generate the cold. It is, therefore, preferably a wireless system.

[0179] Additionally, no external temperature controlling device is required, as temperature control and cooling duration is accomplished via the weight and temperature relationship of the endothermic materials used.

[0180] The endothermically cooled elastic adhesive tape 800 can be similar in appearance to elastic adhesive tape without endothermic cooling.

[0181] The preferred tape embodiment is able to flex, stretch and contour to the skin in a similar way as un-cooled adhesive tape. And, if the stretch component of the fabric insulating layers is primarily in the warp direction, when applied to the skin, the recoil and skin lifting effect provides for a Kinesiology benefit, thus becoming a multi-modality therapeutic product.

[0182] The system is preferably designed as a one-time use product. Once the endothermic reaction period is complete, the product may be removed or remain in place for added Kinesiology benefit.

1. SYSTEM COMPONENTS OF AN EXEMPLARY EMBODIMENT:

FABRIC FEATURES:

- Preferred fabric is a knitted 50% Nylon and 50% polyester blend. - Preferred fabric weight is 75 gsm. RANGE 75 - 250 GSM

- Preferred direction of elasticity in warp direction, with minimal in weft direction.

- Preferred degree of elasticity in the warp direction at 65%.

- Preferably with temperature absorbing qualities.

- Preferably with high contouring properties.

- Preferably with breathable qualities.

- Preferably with high water repellency qualities.

- Preferably without moisture wicking characteristics.

- Conducive to lamination with Thermoplastic Urethane.

2. THERMOPLASTIC URETHANE (TPU) FEATURES :

- Preferred thickness of .015 mm.

- Breathable characteristics.

- Heat and adhesive laminatable to a nylon/polyester fabric.

3. ENDOTHERMIC COOLING COMPOUND :

- Urea or other viable non-toxic endothermic material and H2O.

4. ADHESIVE FEATURES:

- Acrylic or silicone based.

- Skin friendly - tested to meet the ISO 10993 standards for skin sensitization, irritation and cytotoxcicity.

- Latex free

- Hypoallergenic

- Moisture friendly - maintains a high Moisture Vapor Transmission Rate (MVTR).

- Breathable - for adhesive and skin stability.

- Stretchable - to accommodate the elastic characteristics of the adhesive tape. - Repositionable - may be repositioned to the skin with a low-peel release force that does not cause damage or pain, yet maintains tack and adhesion after several applications.

5. EXEMPLARY CONSTRUCTION SEQUENCE OF THE EXEMPLARY

EMBODIMENT:

1. Laminate .015 mm thick TPU layer 902 to one side of a nylon/polyester elastic fabric layer 901 to create the Upper Fabric Sub-assembly.

2. Utilizing RF energy or by heat sealing, encapsulate H2O containing layer 923 between a upper tearable/friable TPU layer 924 and the TPU layer 902 side of the above assembly, in order to complete the Upper Fabric Assembly.

3. Laminate .015 mm thick TPU layers 927, 928 to both sides of a nylon/polyester elastic lower fabric layer 911 to create the Lower Fabric Sub-assembly.

4. Coat or laminate one side of the above Lower Fabric Sub-assembly with adhesive layer 904.

5. Laminate the Release Liner 910 to the adhesive layer 904 of the above Lower Fabric Sub-assembly.

6. Utilizing RF energy or by heat sealing, encapsulate Urea layer 926, or an alternative endothermic reaction material, between a tearable/friable lower TPU layer 925 and the TPU layer 928 side (non-adhesive side) of the above Lower Fabric Sub- assembly, in order to complete the Lower Fabric Assembly.

7. RF or Heat Weld the Upper and Lower Fabric Assemblies together.

8. After die-cutting to size, the Main Assembly is completed.

9. Seal the completed assembly in air tight packaging. [0183] In an alternative construction method the lower tearable TPU layer 925 on the Lower Fabric assembly is not used. In such a construction, the urea (or alternative endothermic material) may be loaded directly onto the Lower Fabric Assembly. After which, the Upper Fabric Assembly may be RF or heat welded directly to the Lower Fabric Assembly. This assembly process eliminates one of the two tearable TPU layers. Also, the water and/or urea, for example, can be loaded into a stretchable tray (or trays separated by tearable or friable layers, not shown) 900 of FIG. 11 A and 1 IB, having diamond shaped containment areas 932, a flange 930 and welded or sealed lines 931. The containment areas 931 can be made friable for mixing, urea and water for example.