Patent Application
20190117447
Not applicable.
Not applicable.
The field of the invention relates generally to devices and methods for controlling the temperature of a human or non-human body. More specifically, the field of the invention relates to wearable devices, which may be worn by a subject, human or non-human, wherein the wearable device is in thermal communication with a portion of the subject's body, such as for example, a portion of the torso, and wherein the wearable device comprises a means for providing a constant or near constant temperature to the subject's body and therefore controls the temperature of the subject's body. The means for maintaining constant or near constant temperature may be a phase change material. The area of the person's body may contain brown adipose tissue. The phase material may transition state at a predetermined temperature which may be higher or lower than the subject's exterior body temperature, providing management of the subject's body temperature in the area in thermal communication with the phase change material. The field of the invention also relates to methods and devices for controlling symptoms related to menopause, post menopause, drug induced or other thermoregulatory symptoms such as hot flashes, night sweats and sleep disturbance.
Devices for controlling the temperature of the human body have historically comprised fluid motivating pumps which circulate a cool fluid through a jacket or similar structure that is located in proximity to and is in thermal communication with a subject's body. These systems are complex, expensive, and prone to failure as they necessarily comprise fluid pumps, tubing, and jackets comprising channels or capillary tubing for fluid communication. Furthermore these systems require electrical power in the form of house current or batteries. For all the above reasons such systems are expensive, prone to failure, and may not be the stated objective due to their shortcomings. Furthermore, these systems are not portable. Thus they may require the wearer to remain in the specific location with access to electric power.
Furthermore, it has long been known that female patients may experience certain physical sensations secondary to the onset of menopause. These physical sensations may include, but are not limited to, sudden sensation of increased temperature on the skin or internal to the body, commonly called “hot flashes”, tingling in the fingers, increased heart rate, skin feeling warm and moist to the touch, face becoming flushed, and sweating. These symptoms, which are generally considered to be caused by hormonal changes in the body that result from the normal process of aging, may be predictable as to timing, or they may come on suddenly without any warning or determined periodicity. Likewise, male patients may experience thermoregulatory symptoms such as sleep disturbance, hot flashes, night sweats and other symptoms secondary to treatments for certain conditions, such as drug therapy using, for example, Lupron or Tamoxifen to treat male patients with prostate cancer. All of these symptom, and any symptoms of thermoregulatory nature, are herein referred to as thermoregulatory symptoms.
The above described symptoms of menopause, which may persist long after menopause has technically ended, or in some post-menopause, have been the subject of attempts for relief by various means. One often use menopause relief technique is the application of medications comprising estrogen, such as the well-known drug Premarin®. However, the estrogen drugs prescribed for relief of menopause systems may come with serious medical side effects such as increased risk of stroke, blood clots, heart attacks or cancer of the uterus. The risk of these very serious side effects prevent many women from choosing to utilize estrogen as a means for controlling the above described symptoms of menopause or post-menopause.
Other suggestions for control and or relief of menopause or postmenopausal symptoms include dressing in layers so as to easily be able to control the thermal insulation around a person's body, natural or homeopathic remedies, sipping ice water or simply wearing little or no clothing. However each of these techniques for controlling or relieving menopause or postmenopausal symptoms come with side effects. Dressing in layers and wearing little or no clothing may not be practical in many social situations. Sipping ice water may not always be practical and is certainly not possible while one is asleep or disposed in a situation where no ice water is available. Consuming natural or homeopathic remedies may have undesired physiological side effects. For example, Black cohosh (Actaea racemosa, Cimicifuga racemosa) has been suggested as possibly relieving symptoms. However, it should not be taken if a subject has a liver disorder. Red clover (Trifolium pratense) may increase the chance of bleeding. Dong quai (Angelica sinensis) interacts with common blood thinners, such as Warfarin. Evening primrose oil (Oenothera biennis) may affect blood thinners and some psychiatric medications. Soy can cause mild stomach aches, constipation, and diarrhea.
What is needed in the art therefore is an apparatus and method for controlling the symptoms of menopause, post menopause, drug induced or other thermoregulatory symptoms that do not expose a subject to unwanted physiological side effects, is easily portable, is usable in most if not all social environments, is safe and is effective in controlling the above described symptoms.
The present invention comprises an apparatus and method that have one or more of the following features and/or steps, which alone or in any combination may comprise patentable subject matter.
One object of the invention is to provide a wearable device operable to control the body temperature of a subject, and, preferably, to control the body temperature of a subject in the area of the subject's body containing brown adipose tissue. Still further, in an embodiment, an object of the invention is to reduce the body temperature of a wearer to a predetermined temperature without causing damage to skin tissue arising from the effects of reducing the skin temperature of the wearer.
Another object of the invention is to reduce the symptoms of menopause, post-menopause, drug induced and other thermoregulatory symptoms; more specifically, to reduce body temperature fluctuations in the wearer during periods of time when the temperature controlling vest of the invention is worn, and preferably also during periods of time when the temperature controlling vest of the invention is not worn.
Another object of the invention is to provide a protocol for the use of a temperature controlling vest for the purpose of reducing body temperature fluctuations in the wearer caused by menopause, post-menopause, drug induced and other thermoregulatory symptoms, or other physiological or environmental conditions.
In accordance with one embodiment of the present invention, the invention comprises a wearable vest, wherein the wearable vest covers a portion of the torso of wearer. In an embodiment the wearable vest may cover a portion of the upper chest, upper back and a portion of the region between the acromion and the neck of the wearer, bilaterally. The wearable vest may, in yet a further embodiment, cover a portion of the neck or shoulders, or both, of the wearer.
The present method and device of the invention overcome the shortcomings of the prior art and that they are operable to control body temperature of a wearer, they have been demonstrated to control and/or manage the symptoms of menopause, post-menopause, drug induced and other thermoregulatory symptoms, or other physiological or environmental conditions and to manage skin temperature, and they have no adverse physiological side effects nor do they damage the skin of the wearer. The device and method of the invention are specifically designed such that they may be utilized for long periods of time at temperatures above that which caused damage to the skin of the wearer.
The accompanying drawings, which are incorporated into and form a part of the specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating the preferred embodiments of the invention and are not to be construed as limiting the invention. In the drawings:
In the figures, like callout number refer to like features.
The following documentation provides a detailed description of the invention.
All temperature values stated in this application are to be interpreted as referring to degrees Fahrenheit unless otherwise specified.
Although a detailed description as provided in the attachments contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following preferred embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention. Thus the scope of the invention should be determined by the appended claims and their legal equivalents, and not merely by the preferred examples or embodiments given.
As used herein, “phase change material” or “PCM” means a substance or combination of substances with a heat of fusion which, when melting or solidifying at a phase transition, or phase change, temperature TPC enables the substance to absorb or release amounts of heat energy. Heat is absorbed or released when the substance changes state as from from solid to liquid, and vice versa, at the phase transition, or phase change, temperature TPC. TPC is a function of the physical properties of the phase change material. Phase change materials may comprise eutectic materials, salt hydrates, or organic materials. Eutectic materials tend to be solutions of salts in water that have a phase change temperature below 0° C. (32° F.). Salt hydrates are specific salts that are able to incorporate water of crystallization during their freezing process and tend to change phase above 0° C. (32° F.). Organic materials used as PCMs tend to be polymers with long chain molecules composed primarily of carbon and hydrogen. They tend to exhibit high orders of crystallinity when freezing and mostly change phase above 0° C. (32° F.). Examples of materials used as positive temperature organic PCMs include waxes, oils, fatty acids and polyglycols. The definition of “phase change material” or “PCM” further includes compositions comprised of more than one such substance, i.e., mixtures of phase change materials. Examples of substances which are phase change materials are shown in Table 1.
As used herein, “plastic” includes within its meaning a material consisting of any of a wide range of synthetic or semi-synthetic organics that are malleable and can be molded into solid objects of diverse shapes. Plastics are typically organic polymers of high molecular mass, but they often contain other substances. They are usually synthetic, most commonly derived from petrochemicals, but many are partially natural. Examples of plastics include but are not limited to polyester (PES); polyethylene terephthalate (PET); polyethylene (PE); high-density polyethylene (HDPE); polyvinyl chloride (PVC); polyvinylidene chloride (PVDC) (Saran); low-density polyethylene (LDPE); polypropylene (PP); polystyrene (PS); high impact polystyrene (HIPS); polyamides (PA) (Nylons); acrylonitrile butadiene styrene (ABS); polyethylene/Acrylonitrile Butadiene Styrene (PE/ABS); polycarbonate (PC); polycarbonate/Acrylonitrile Butadiene Styrene (PC/ABS); polyurethanes (PU); maleimide/Bismaleimide; melamine formaldehyde (MF); plastarch material; phenolics (PF) or (phenol formaldehydes); polyepoxide (Epoxy); polyetheretherketone (PEEK); polyetherimide (PEI) (Ultem); polyimide; polylactic acid (PLA); polymethyl methacrylate (PMMA) (Acrylic); polytetrafluoroethylene (PTFE); urea-formaldehyde (UF); furan; silicone; and polysulfone, or any combination of these materials.
As used herein, “brown adipose tissue”, “brown adipose fat”, “BAT”, BATF″ and “brown fat” all have the same meaning. In additional to the meaning given these terms as is known in the art, these terms include within their meaning fat tissue that contains many small lipid droplets and a high number of iron-containing mitochondria, is at least partially characterized as burning energy and glucose to make heat.
As used herein, “° F.” shall mean degrees Fahrenheit.
As used herein, “wearer”, “subject”, “person” and “user” mean a person who is wearing a temperature controlling vest of the invention.
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Thus, in an embodiment, a temperature controlling vest of the invention 001 may be fabricated, having an interior surface comprising interior layer 122 of polyurethane and an exterior surface of 100% nylon fabric with polyester foam core and nylon tricot backing such as the product VELTEX® produced by Velcro Industries B.V. CORPORATION NETHERLANDS 22-24 CASTORWEG CURACAO NETHERLANDS ANTIL forming the loop portion of a hook and loop fastener system. The vest may comprise a plurality of cells 100, each cell 100 forming an interior volume capable of containing a PCM 121 such that the PCM 121 is prevented from escaping the enclosed volume of the cell.
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The length of time required for the PCM 121 to change state is a function of the volume of PCM 121 contained with the cells and the temperature differential between the PCM 121 and wearer's body. The larger the temperature differential, the faster heat will transition from a surface of the wearer's body 123 to the PCM 121 and the faster the PCM 121 will transition state. Also, the larger the volume of PCM 121 material contained within each cell, the longer it will take, in terms of time, for the PCM 121 to change state. Additionally, the thickness of each cell and thus the flexibility and comfort of the vest 001 of the invention are affected by the volume of PCM 121 disposed in the cell. When the volume of PCM 121 in a cell is increased, the flexibility of the vest is reduced, and vice versa. Methods of the invention for determining the PCM 121 to be used in the invention, and for optimizing the volume of PCM 121 contained with a cell are to 1) determining a desired temperature T to be applied to the body of a wearer; 2) determining the temperature drop ΔT between the body of the wearer and PCM 121 taking into account all intervening materials; 3) determining the desired temperature TPC at which the PCM 121 must change state in order to apply the desired temperature T to the body of a wearer by adding ΔT to T; and 4) selecting a PCM 121 or combination of PCMs 121 that will transition state at the desired PCM 121 transition temperature TPC to be disposed within the cells of the invention; further, optionally, the volume of PCM 121 to be disposed within a cell of a vest of the invention may be determined by 5) determining a desired flexibility of the vest; 6) determining the volume of the specific PCM 121 selected that is required to achieve the minimum flexibility of the vest. Step 6) may be carried out by trial and error by producing a prototype vest 001 with a specific volume of PCM 121 disposed within the vest and then increasing or decreasing the volume of PCM 121 disposed within the cells of the invention until the volume of PCM 121 in the cells to achieve the desired flexibility of the vest is achieved.
The above described process may also be reversed such that the wearer's body 123 absorbs heat from the PCM 121 as depicted by G in
In the above manner, PCM 121 is in thermal communication with surface of a body of a subject 123. In embodiments of the methods described below, the surface of the subject's body 123 is in an area of the body containing brown adipose tissue such that the wearing of the vest by a subject causes a desired temperature change in the brown adipose tissue of the subject.
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In alternate embodiments of the method, more than one PCM may comprise the PCM utilized in the invention, resulting in the use of a PCM mixture, as may be necessary to achieve a specific desired PCM phase change temperature TPC, or to achieve any desired step function in, or duality of, PCM phase transition temperature TPC. In further alternate embodiments of the invention, one or more covering materials may be utilized, and each may be analyzed for thermal conductivity in order to achieve the desired thermal transfer between the body of a user and the temperature control pad. Still further, in any embodiment of the invention, the PCM material may be mixed with graphene to enhance the PCM thermal transfer properties. In an embodiment, the amount of graphene mixed into the PCM may be up to ten percent graphene to PCM, by weight. In further embodiments, the amount of graphene mixed into the PCM may be higher than ten percent graphene to PCM, by weight.
It is to be understood that the outline shapes and cell shapes of the temperature controlling vest of the invention is depicted as representative shapes 001 and 002 in the figures, and that the scope of the invention encompasses all other shapes, and all other embodiments that are able to be applied to other areas of a subject's body, and especially all other areas of a subject's body in which the use of a temperature controlling apparatus of the invention results in thermal communication between a PCM and brown adipose tissue of a subject. The use of the term “vest” is for convenience only as an aid in referring to the temperature controlling apparatus of the invention and is not be construed as limiting the claimed invention to only vest shapes. Thus the term vest is inclusive of all other shapes.
Use of the temperature controlling vest 001 or 002 of the invention to cool or otherwise modulate the body temperature of the wearer in the area of the wearer's body that is in contact with the vest or near the vest may stimulate brown adipose tissue (BAT) by cooling or warming the user's BAT in the area of the user's body that is in contact or near the temperature controlling vest of the invention, which in turn causes hormonal responses in the wearer's body restuling in a desired thermoregulation of the wearer's body, and thus reducing one or more symptoms such as hot flashes, night sweats, sleep disturbance, tingling in the fingers, increased heart rate, skin feeling warm and moist to the touch, face becoming flushed that may be associated with menopause, aging, chemical use, or drug use that may be related to therapies for treating unrelated medical conditions such as prostate cancer.
Accordingly, the invention further comprises methods for such use. In a general embodiment, the method comprises the steps of determining a desired phase change temperature for the PCM, selecting a PCM that is characterized by a phase change at the selected phase change temperature, and the user wearing a temperature controlling vest comprising the selected PCM in accordance with a protocol thus cooling the user's BAT.
In an embodiment, the invention comprises a method for relief from menopause symptoms such as body temperature swings, hot flashes, fluctuation in skin temperature, and other temperature-related symptoms. In a further embodiment, the invention comprises a method for treating hormonal fluctuation and the symptoms of hormonal fluctuation in male patients that may result from chemical or drug use, such as, for example, the use of drug therapy using Lupron or Tamoxifen to treat prostate cancer. These antiestrogen medications/aromatase inhibitor medications modulate hormonal responses resulting in chemically induced disruptive thermoregulatory symptoms causing, for example, but not limited to, hot flashes and night sweats in men and women. However, when the invention is charged to a temperature below body temperature, for example in the range of TPC of between 48° F. to 65° F., inclusive, and is worn by a user thus cooling the user's brown adipose tissue, there has been shown to be a resulting beneficial effect of reducing these body temperature fluctuation-related symptoms.
In an embodiment, the above symptoms may be relieved or controlled by the lowering of the wearer's body temperature that results from the wearer's wearing a temperature controlling vest of the invention in contact or near a user's BAT, wherein the vest comprises PCM material that is selected by the process of the invention to transition phase at a temperature TPC. While the temperature TPC may be any temperature below 98.6° F., preferred ranges of TPC are 45° F. to 80° F.; 45° F. to 59° F., 60° F. to 69° F.; 70° F. to 80° F.; 48° F. to 65° F. and any range within 45° F. to 80° F.
Exemplary protocols of the method of the invention for treating menopause symptoms in female patients are as follows. In a first protocol, the wearer wears a temperature controlling vest of the invention comprising PCM selected to change state at any temperature identified above for TPC for designated periods during a day. In a second protocol, the wearer wears a temperature controlling vest of the invention comprising PCM selected to change state at any temperature identified above for TPC for a period of thirty (30) minutes prior to breakfast each morning and thirty (30) minutes prior to dinner for a specified period of days. In a third protocol, the wearer wears a temperature controlling vest of the invention comprising PCM selected to change state at any desired temperature or any temperature identified above for TPC for a period of thirty (30) minutes prior to breakfast time and continuing for an additional thirty (30) minutes after the beginning of breakfast time for a total of sixty (60) minutes each morning, and then again thirty (30) minutes prior to dinner time and continuing for an additional thirty (30) minutes after the beginning of dinner time for a total of sixty (60) minutes, all together totaling one hundred twenty (120) minutes each day, for a specified period of days. As used herein, “breakfast time” and “dinner time” may be defined as having their ordinary meaning. Alternatively, “breakfast time”, in an embodiment, is defined as occurring between 6:00 am and 9:00 am, and “dinner time” in an embodiment is defined as occurring between 4:00 pm and 7:00 pm. The terms “breakfast time” and “dinner time” are use solely used to identify the above times and not any activity related to consumption of food. In other words, the consumption of food is not be construed as a limitation in the claims.
This international patent application, filed under the Patent Cooperation Treaty (PCT), claims benefit of priority to U.S. provisional patent application No. 62/318,377, filed in the United States Patent and Trademark Office (USPTO) on 5 Apr. 2016, titled TEMPERATURE CONTROLLING VEST AND METHOD OF MANUFACTURING AND USE FOR RELIEVING OR CONTROLLING MENOPAUSE AND POST-MENOPAUSE SYMPTOMS, which is herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US17/26246 | 4/5/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62318377 | Apr 2016 | US |
