Wearable cooling or heating devices to prevent chemotherapy complications

Abstract

Systems, devices, and methods for monitoring one or more parameters of fluid flow to an area of ​​a user undergoing treatment. The fluid may flow along a fluid path from a cooling or heating device to a heat exchange article wearable by the user. Heat exchange may occur between one or more areas of the user and the fluid flowing through the heat exchange article. Sensors monitor one or more parameters, and one or more details of the fluid may be automatically or manually controlled based on treatment requirements or user desires. Devices, systems, and methods of cooling and / or heating device embodiments may provide several hours of uninterrupted cooling and / or heating treatment to a user. (See FIG. 15)

Description

WEARABLE COOLING OR HEATING APPARATUS FOR THE PREVENTION OFCOMPLICATIONS DUE TO CHEMOTHERAPYBACKGROUNDFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to cooling or heating one or more parts of the body. More precisely, the present application relates to an apparatus and system for controlling a device for continuous cooling or heating of one or more parts of the body for a set period of time.DESCRIPTION OF THE RELATED ART

[0002] Cooling and heating body parts has many therapeutic uses. For example, cooling can effectively treat acute injuries by reducing pain and inflammation. It can also be used to relieve pain for tendinitis, arthritis, and neuropathy, for example. Likewise, heating can be used to relieve conditions such as stiff joints, arthritis, trigger finger, inflammation, Raynaud's, and carpal tunnel syndrome. Sometimes the cooling or heating also incorporates cyclical pressure, to increase circulation, which facilitates inflammation reduction and healing.

[0003] These techniques are for transient application, typically 20 minutes or less, of cold or hot, to avoid tissue damage. Because of that, there is no need for normal human function, for example walking (when cooling / heating feet) or using a phone (when cooling / heating hands), while using the device, and the wearable portion of these devices is typically bulky.

[0004] Accordingly, a device that allows safe, continuous cooling and heating temperatures, for long periods of time, such as several hours is desired.SUMMARY

[0005] Accordingly, the object of the present disclosure is to provide a device for cooling or heating one or more parts of the body that allows the user to function normally while cooling or heating. The device of one or more embodiments can be used in several applications, for example for pain relief or cooling on the day of chemotherapy to prevent chemotherapy-induced peripheral neuropathy.

[0006] Note that this summary section does not specify every embodiment and / or incrementally novel aspect of the present disclosure or claimed invention. Instead, this summary only provides a preliminary discussion of different embodiments and corresponding points of novelty. For additional details and / or possible perspectives of the invention and embodiments, the reader is directed to the Detailed Description section and corresponding figures of the present disclosure as further discussed below.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] A more complete appreciation of the disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

[0008] FIG. l is a cooling and heating unit according to an embodiment of the present disclosure.

[0009] FIG. 2 is a view showing internal elements of the cooling and heating unit according to an embodiment of the present disclosure.

[0010] FIG. 3 is a view showing internal elements of the cooling and heating unit according to an embodiment of the present disclosure.

[0011] FIG. 4 is a view of exemplary power suppliers according to embodiments of the present disclosure.

[0012] FIG. 5 is a view of a garment to be worn by a user to utilize heating or cooling fluid according to an embodiment of the present disclosure.

[0013] FIG. 6 is an exploded view of various layers of a garment to be worn by a user according to an embodiment of the present disclosure.

[0014] FIG. 7 is an external view of a garment to be worn by a user according to an embodiment of the invention.

[0015] FIG. 8 shows a strain relief logo badge according to an embodiment of the invention.

[0016] FIG. 9 is a schematic view of a system including a user device communicatively connected to an apparatus, according to an embodiment of the present disclosure

[0017] FIG. 10 shows a connector device for connecting to tubing to allow fluid flow into / out of the heating or cooling device, or into / out of the garment according to an embodiment of the invention.

[0018] FIG. 11 is an alternative view of the strain relief shown in Fig. 8 according to an embodiment of the invention.

[0019] FIG. 12 is a view of the manifold shown in Fig. 5 according to an embodiment of the invention.

[0020] FIG. 13 shows a glove seal pattern according to an embodiment of the invention.

[0021] FIG. 14 shows a tube sleeve cap according to an embodiment of the invention.

[0022] FIG. 15 shows a user utilizing various aspects of the invention.

[0023] Figs. 16A-16E show gloves according to an exemplary embodiment of the invention.

[0024] Figs. 17A-17B show exemplary emobdiments of a glove.

[0025] Figs. 18A-C show exemplary embodiments of a glove.

[0026] Figs. 19A-19C show elements of the structure providing fluid flow.

[0027] Figs. 20-20B show gloves according to embodiments of the invention.

[0028] Figs. 21A-21B show gloves according to embodiments of the invention.

[0029] Fig. 22 shows a glove according to embodiments of the invention.

[0030] Figs. 23A-23D show booties according to exemplary embodiments of the invention.

[0031] Figs. 24A-24G show exemplary embodiments of the invention.

[0032] Figs. 2 A-25C show exemplary embodiments of the invention.

[0033] Figs. 26A-26C show further exemplary embodiments of the invention.DETAILED DESCRIPTION

[0034] The following disclosure provides many different embodiments, or examples, for implementing different features of the disclosed subject matter. Specific examples of components and arrangements are described below to simplify the present disclosure. These are, of course, merely examples and are not intended to be limiting. For example, the formation of a first feature over or on a second feature in the description that follows may include embodiments in which the first and second features are formed in direct contact, andmay also include embodiments in which additional features may be formed between the first and second features, such that the first and second features may not be in direct contact.

[0035] In addition, the present disclosure may repeat reference numerals and / or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and / or configurations discussed. Further, spatially relative terms, such as “top,” “bottom,” “beneath,” “below,” “lower,” “above,” “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. The spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. The apparatus may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein may likewise be interpreted accordingly.

[0036] The order of discussion of the different steps as described herein has been presented for clarity’s sake. In general, these steps can be performed in any suitable order. Additionally, although each of the different features, techniques, configurations, etc. herein may be discussed in different places of this disclosure, it is intended that each of the concepts can be executed independently of each other or in combination with each other. Accordingly, the present invention can be embodied and viewed in many different ways.

[0037] To this end, Fig. 1 is a schematic view of a device 1 for cooling or heating that uses a thermoelectric solution to decrease or increase the temperature of a circulating fluid, such as water, to cool or heat a portion of a user’s body. It is within the spirit and scope of the present invention that any fluid that can be heated or cooled can be used as a circulatingfluid. The device l is a portable device which means for example that users can easily carry the device or wear it or transport it, allowing them to freely move around in daily life and take the device with them to / from different locations, all while cooling or heating.

[0038] The housing 2 can include a user interface display 3 for displaying information to the user. The user interface can include input elements and output elements. Examples of input elements may include microphones, keypads, touchscreens, sensors, etc. Examples of output elements may include speakers, one or more display screens, and tactile devices.

[0039] In an embodiment, the user interface 3 can be used for controlling temperature setpoint and viewing current temperature of the circulating liquid. The user interface display 3 can, for example, report the temperature of the patient’s skin, report the set point for the coolant and the actual coolant temperature, provide information such as an on / off status, a time completed / remaining associated with the treatment of the body part, power status such as battery life, as well as visually displaying any notifications to the user such as any errors associated with the operation of the device. The device 1 can also provide any of the above discussed information with an audio message.

[0040] According to an embodiment, input elements such as control buttons 4 can be included that allow the user to control various functions of the device 1 in conjunction with the user interface display 3 or separately therefrom. For example, the buttons 4 can allow the user to power on or power off the device 1. Further, the user can utilize the buttons 4 to increase or decrease a temperature of the fluid flowing through the system, and to scroll through various functions of the device 1.

[0041] According to embodiments of the invention, the device 1 includes a fluid inlet 5 and a fluid outlet 6 extending through the housing 2, which respectively allow a fluid toflow into the housing 2 and out from the housing 2 to circulate the fluid through the device 1 and to the article to be worn by the user via tubing, described in further detail below.

[0042] It should be appreciated that the device 1 can include any number of fluid inlets 5 and fluid outlets 6 for carrying fluid to / from the device 1 and to / from the article used by the patient. For example, one or more tubes can flow from the device 1 to a first glove, and / or a second glove, and / or a first bootie, and / or a second bootie, simultaneously. In this way, temperature of the fluid flowing to articles worn by the user can be controlled to be the same or different.

[0043] Fig. 2 shows internal elements of the device 1 according to an embodiment of the invention. The device 1 uses a temperature controller that either heats or cools the fluid circulating through the system. For example, a thermoelectric assembly 7 is provided, which employs Peltier elements to manage the temperature of circulating fluid used to cool / warm the user’s body parts, such as hands and feet. Embodiments of the device 1 can use any known device that can raise or lower the temperature of a fluid that circulates through a system.

[0044] As shown in Fig. 3 in an embodiment of the invention, a sensor 9 is provided, which senses the temperature of the circulating fluid. The sensor 9 can be a thermistor for example. It should be appreciated that a plurality of sensors 9 can be located in the device 1 and / or any part of the device, for example parts that are worn by the user to detect for example the temperature of the fluid.

[0045] In an embodiment, the device 1 can include a controller for controlling the various functions of the device. For example, a TEC controller 15 is provided, which is an electronic instrument or component that for example can output current and voltageinformation / data to the thermoelectric assembly 7 while being controlled from the feedback it is receiving from any sensor, for example the temperature sensor 9. Therefore, in one or more embodiments of the invention, the device 1, for example via the controller 15, can interface electrically with one or more electrical sensors 9 provided with the item to be worn by the user, for example one or more gloves or boots discussed later.

[0046] The TEC controller 15 may include a processor. The processor can be implemented as one or more integrated circuits (e.g., one or more single core or multicore microprocessors and / or microcontrollers), and is used to control the operations of cooling or heating device 1. The processor can execute a variety of programs in response to program code or computer-readable code stored in memory, and can maintain multiple concurrently executing programs or processes. For example, the controller 15 can include a feedback control system such that the sensed parameters by the feedback control system can be used to adjust the characteristics of the treatment, for example fluid temperature and fluid flow rate, performed by the cooling or heating device 1.

[0047] The device 1 allows for a safe, continuous cooling and heating temperatures, for long periods of time, such as several hours if desired. Accordingly, the devices, systems and methods of embodiments of the cooling and / or heating apparatus can provide for multiple hours of uninterupted cooling and / or heating treatment to the user that is controlled by the systems of the device which allows the user to continue with other activities if desired, without having to worry about controlling the operation of the device and the treatment conducted.

[0048] In a further embodiment, the device 1 can also provide cooling and heating temperatures via the flow of fluid through the system, intermittently for any period of time.For example, the device can be programed by the user to provide continuous treatment for a specific period of time and / or to provide intermittent treatment. It should be appreciated that any length of time of continuous and / or intermittent treatment by the device 1 is contemplated by the various embodiments of the invention.

[0049] Further, one or more embodiments of the invention can provide for multiple sessions of continuous and / or intermittent treatment, with one or more periods of time of no treatment in between. The periods of time of no treatment can include time when fluid is flowing throught the device 1 and various tubes and other systems of the apparatus.

[0050] According to embodiments of the invention, the user can have access at all times to the device to control the cooling and / or heating device 1 to ensure that the devcie and the treatment provided is as desired and is comfortable for the user. The device 1 or control device for the device such as a remote controller of the device, should be easily accessible by the user during operation.

[0051] In one or more embodiments of the invention, the user primes the one or more devices and / or controllers of the various systems and / or apparatuses so that the treatment provided thereby is controlled by the user. As an alternative, the one or more devices and / or controllers of the various systems and / or apparatuses can be provided pre-primed, that is pre-programmed, so that the user is only required to turn on the apparatus(s) and activate a start treatment button to begin treatment. In this way, the operation of the device is simple with few steps and the user can quickly begin treatment, which can also reduce the possibility of user error for beginning treatment.

[0052] In an embodiment, a pump 12 is used to circulate liquid from the thermoelectric assembly 7 to subsystems that are designed to cover a specific body part, like gloves and boots, and accessories, discussed in more detail later.

[0053] In an embodiment, a pump speed adjustment and motor control 13 is a subsystem that can include a potentiometer and motor controller that can be used to change the flow rate of the fluid through the system, that is the flow rate of the fluid from the device 1 to the assembly covering the body part.

[0054] In an embodiment, a power supply 8 is provided. The power supply 8 can be an electrical device that supplies electric power to an electrical load, ensuring that controlled voltage and sufficient current are provided to the system.

[0055] Fig. 4 shows an example of a power supply that provides power to the various elements of device 1. For example, an AC power cord 17 is utilized to transmit power from a wall outlet to the power supply, via a power entry module. The power supply performs the AC / DC conversion. As an alternative power supply, a car adapter 18 can provide an interface to an electric outlet or adapter in a motor vehicle. It should be appreciated that any known device that supplies power can be utilized in the various embodiments of the invention.

[0056] According to one or more embodiments of the invention, a rechargeable battery can be included with device 1. When the device 1 detects that it is not plugged into either AC or DC power, the rechargeable battery powers the device. When the device is plugged into AC or DC power, the battery can recharge.

[0057] As discussed above, the housing 2 can include a controller connected to for example a user interface display 3 for displaying information to the user. The user interface3 can be used for controlling temperature setpoint and viewing current temperature of the circulating liquid. Utilizing the controller of the device 1, the desired temperature can be set to a set point, and then the user can adjust the temperature up or down, for comfort after the circulation of the fluid has begun if desired. Also, the user can for example, set the amount of time required to attain the set point, and the amount of time required to reach room temperature at the end of treatment. Also, in one or more embodiments, the systems of the present invention can be set for continuous flow of the fluid for treatment or can be set for intermittent flow of the fluid for treatment.

[0058] In an embodiment, the controller of the device 1 includes a feed-back loop so that the device 1 can automatically adjust to change the temperature or flow rate of the circulating fluid to achieve a desired temperature at the skin surface for example.

[0059] In a further embodiment, the device 1 can be instructed to control parameters of the treatment, such as fluid temperature, to go to a set target point, and then the user can adjust the temperature thereafter, for example by one degree increments. It should be appreciated that any amount of temperature adjustments can be made, such as by tenths of a degree or multiple degrees at a time. Further, upper and / or lower limits can be set for how far the user can adjust the parameter, such as temperature, to adjust for comfort while keeping the temperature within an efficacious range for certain applications or treatments.

[0060] In embodiments, the device 1 can cool the fluid to 15°C in 15 minutes from room temperature. The device 1 can have more or less than a 200W thermal capacity, which will allow the fluid flowing through the device 1 and one or more tubes, to be cooled to the desired temperature.

[0061] The cooling or heating device 1 shown in Figs. 1 -3 is a representative image of the cooling or heating unit shown in Fig. 1. Ultimately, the device 1 can be stored and / or housed and / or carried in a portable container or bag, such as a backpack or other carrying structure having straps for example to allow for easy transport by the user. For users who might not have the ability to carry the device, the device 1 can also be incorporated into a rolling structure that stores and / or houses the device 1 and also can include a handle, telescoping for example, and wheels for easy rolling transport by the user.

[0062] While embodiments of the invention of the device 1 can cool or heat any portion of a user’s body, described herein is the use of the device 1 to cool or heat multiple body parts alone or simultaneously, as an example, one or both hands and / or one or both feet, as shown in Fig. 15. For all body parts, the design must necessarily incorporate the ability to use that body part in normal functioning while being treated by the device 1.

[0063] As shown in Figs. 5-7 with respect to one or more embodiments of the invention, the system for heating or cooling one or more parts of the body can include a glove 20 that will interface directly with the device 1 via the inlet 5 and the outlet 6 by way of a fluid pathway that includes one or more tubes 21, 22 and one or more connectors 23, 24. Various connectors are shown in Figs. 24A-24G. It should be appreciated that the device 1 according to one or more embodiments of the invention can include more than one set of inlets and outlets 5, 6 connected with respective tubes 21, 22 in order to for example, allow the user to treat one or both hands with one or two gloves 20 and / or treat one or both feet with one or two boots as discussed later, utilizing the device 1 at the same time for the one or more parts of the body.

[0064] It should be appreciated that other items to be worn or placed on a user’s body can be utilized with the device 1 to cool or heat a desired region of the body. For example, a garment or apparel that is worn by a user, such as a shirt or pant like garment, can incorporate one or more tubes that carry fluid within the tubes to one or more desired regions of the garment. Incorporating the tubes within and / or on a surface of the structure of the garment allows the user to be comfortable wearing the garment while also keeping the tubes close to the user’s body to optimize the effects of the fluid flowing therein.

[0065] In a further example, a cushion is provided which can be sat on by the user. This seat cushion can include one or more tubes to carry fluid to one or more regions of the seat cushion to provide cooling fluid to a desired region for treatment of a user sitting on the seat cushion. The tubes can be incorporated into the material and structure of the seat cushion and / or be provided on an external surface of the seat cushion. The seat cushion one or more sections with each of the one or more sections having the same or a different number and / or length and / or size of tubes provided therewith. In this way, the tubes and corresponding hose connections can be kept close to the patient and near each limb desired to be treated.

[0066] In a further example, an item to be worn or placed over a user can incorporate one or more tubes for carrying fluid. For example, a bib, salon-like front cape and / or a life vest like item that include an neck opening for fitting over a user’s head can incorporate the tubing features of one or more embodiments of the invention. The item to be worn could include an opening / closing feature for the neck opening to increase the ease of placing the on the user. The tubing incorporated into these items to be worn increases the patients comfort while wearing the item, and also keeps the tubing close to the patient’s body, forexample near the sternum, to enhance the effects of the fluid flowing therein and treatment of the desired region of the body.

[0067] In a further example, the one or more tubes can be incorporated into a blanket which would cover the user and provided a fluid flow through one or more desired regions of the blanket. In one embodiment, the blanket could include a fluid storage / circulation hub within the blanket structure, which would allow for the fluid to flow to the hub before being directed to one or more tubes for circulation to one or more desired regions of the blanket.It should be appreciated that the fluid can flow to the hub when the fluid is being directed to the blanket from the device 1 and / or directed to the hub when the fluid is being directed out of the blanket and to the device 1.

[0068] In an embodiment of the invention, a blanket could be a heated blanket, such as an electrically heated blanket, that further includes one or more tubes to carry cooling fluid to one or more regions of the blanket. In this way, the heated portion of the blanket can keep the user warm, while simultaneously the regions of the blanket that include the one or more tubes carrying cooling fluid can cool the specific desired regions of the blanket.

[0069] In a further example, one or more tubes can carry fluid to / from / within the blanket directly from the device 1 thereby bypassing the hub, while simultaneously one or more tubes can carry fluid from the device 1 and to / from the hub before directing the fluid to the desired regions of the blanket.

[0070] The one or more tubes 21, 22 are connected with the device 1 at one end while connected to the for example glove 20 at another end. The one or more tubes 21, 22 are of a sufficient length to allow them to connect with the device 1 while the user is wearing theglove 20 and avoid the tube length to be under excessive tension, or a nuisance to the user performing normal tasks.

[0071] The tubes 21, 22 can connect to the glove 20 at the connectors 23, 24. The connectors 23, 24 can include seals to prevent leaking of the fluid entering or exiting the glove 20. Tube 21 is securely connected to the glove 20 via the connector 23 so as to provide an inlet path for flow of fluid into glove 20. Tube 22 is securely connected to the glove 20 via the connector 24 so as to provide an outlet path for the flow of fluid out of the glove 20.

[0072] In an embodiment, the fluid flowing into the glove 20 via the inlet tube 21 can initially flow into an inlet bladder shown in Fig. 16A, or reservoir to temporarily collect the fluid before the fluid is transported though the glove 20. Thereafter, the fluid can be delivered to the base of the user’s hand, travel to the fingertips, and flow into an outlet bladder or reservoir, which then flows to the outlet tube 22, and then returns to the device 1. In embodiments of the invention, it should be appreciated that the interior of the glove 20 can include any number of reservoirs and / or bladders that can be utilized to help at least temporarily store or hold fluid that is being pumped through the glove 20.

[0073] In a further embodiment, the bladder can be a layered bladder. The layered bladder could include a lower region and an upper region. The lower region would include an external surface configured to contact the user and would carry the cooled fluid for treatment of the patient. The upper region of the bladder, for example positioned further from the patient’s body than the lower region, would carry fluid that has been warmed by treatment with the patient to the exterior of the article, for example a glove 20, and back to the device 1.

[0074] It should be appreciated that the tubes carrying the fluid can have a similar layered structure that allows separation of the fluid flow paths that carry fluid of different temperatures. For example, within the tube 26, one or more fluid flow paths can be provided therein. As an example, within the tube 26, one or more flow paths can be used to carry the cooling fluid, while one or more flow paths could be used to carry warmer fluid that has been already circulated through the system to the outside of the article, for example the glove 20. As a further example, one or more internal flow paths of the tube 26 could carry the cooling fluid and one internal flow path could carry the warmer fluid. It should be appreciated that the internal flow path for the cool and warm fluid can be the same or different sizes.

[0075] The glove 20 can resemble winter gloves in shape for example, and include capacitive material or capacitive device on one or more finger-tips to allow the user to use a touch screen device throughout treatment, shown in Fig. 22. In an example, the glove 20 can have openings at the fingertips to leave the finger pad exposed, shown in Fig. 21A. Alternatively, the fingertips of the glove 20 can include conductive pads to aid in the use of an electronic device, shown in Fig. 21B. In an example, the gloves could have all fingers and thumbs separate, or for example, all fingers together with the thumb separate, such as a mitten, or any combination thereof.

[0076] In an embodiment, the glove 20 will also include a barrier near the base of the glove to help provide insulation. As shown in Figs. 7-8, the outer base of the glove 20 can include a strain relief feature 30 and a location to place company logo and / or labelling.

[0077] In an embodiment, the flow of fluid into the glove 20 through the tube 21 and connector 23 can flow to a manifold-like structure 25 that can separate the fluid across one or more fluid pathways, for example fluid flow channels 26.

[0078] In embodiments, valves can be utilized in any of the structure of the invention to control the flow of fluid in one or more regions of the device 1 and / or within the glove 20 and / or boots to be worn by the user.

[0079] In the example of the winter glove structure, 5 different fluid flow channels 26 can be utilized to dispense fluid through the respective separate channels to each of the fingers of the glove 20. The flow channels 26 are for example, tubes that guide the flow of fluid within the glove.

[0080] In the example of a mitten type glove 20, one or more flow channels 26 can be positioned along the thumb region of the glove 20, while one or more channels 26 can be directed to the region of the glove 20 having the remaining fingers of the user. It is within the spirit and scope of the invention to have any number of channels 26 provided within the glove to facilitate the flow of fluid to any desired region of the glove. Additionally, the channels can have any size or shape, which are the same or different from the other channels in the glove 20, shown in Fig. 19C. For example, the thumb region of the glove 20 can have a larger or smaller sized channel 26 than the channels 26 positioned in other regions of the glove 20.

[0081] As a further example, the channels 26 can spiral around one or more of the finger regions of the glove 20 to maximize finger cooling, shown in Fig. 17A. As a further example, fluid channels 26 can extend directly to the fingertips to provide maximum fluid flow around the ends of the fingertips, shown in Fig. 17B.

[0082] Within the glove 20, the separate channels 26 can run along the region adjacent to the back and / or front of the user’s fingers and / or palm and / or back of the user’s hand. The size and shape of the channels 26 is not limited and the position of the channels 26 can be located at or absent from at any location within the glove to provide or avoid cooling or heating from the fluid to desired region(s) of the glove 20 and therefore the desired region(s) of the hand and / or fingers of the user.

[0083] As a further example of the invention, the separate channels 26 can be positioned within the glove 20 to extend over the back or top side of the hand and / or along the top side of the fingers and / or the palm of the hand. According to this non-limiting example, the channels 26 do not extend within the glove in a region of the glove near or adjacent the underside of the fingers. Further, a cooling section can be created for the glove and attached to a base liner glove, shown in Fig. 20A.

[0084] In an embodiment, one or more portions of the glove 20 can be made from a weaving material that includes coolant channels, for example channels 26, incorporated into the weave. According to an example, the weaving material including the channels, can be incorporated into only the regions of the glove 20 for which heating and / or cooling is desired. For example, with respect to the heating and / or cooling of the region of the glove at the fingers, the weaving material can be only incorporated into the area of the glove adjacent the top of the fingers. In this way, a size or bulk of the glove 20 can be reduced which will maximize dexterity for the user while wearing the glove 20.

[0085] In a further embodiment, the glove 20 can include one or more pockets of a substance that is able to be heated or cooled, such as a gel. The pockets can be positioned inareas adjacent to one or more of the channels to provide an even distribution of the cooling or heating from the fluid flowing in the channels 26.

[0086] In a further example, the glove 20 can include a plurality of layers to provide cooling, and / or protection, and / or insulation, shown in Fig. 18A-18B. For example, a conductive gel like layer can be provided within or around which the tubes 26 can extend, shown in Fig. 18C. In this way, the cooling fluid can cool the gel, and the cooled gel would provide a greater surface area of cooling for treatment of the patient. The glove 20

[0087] After the fluid flows in and / or around the region of one or more fingers, the fluid can flow out into a bladder and / or reservoir before proceeding to the outlet tube 22.Alternatively, after the fluid flows in and / or around one or more fingers, the fluid from each of the channels 26 can merge directly into the outlet tube 22 and exit the glove 20.

[0088] In an embodiment, the design of the one or more bladders and / or reservoirs could be different. For example, one bladder could have cooling only on a portion of the hand, for example the back or palm without the fingers. A further bladder could have a different design, for example have one compartment with separations such as quilting, or coiled tubing.

[0089] In an embodiment, the systems and devices of the invention can be programmed to control the fluid during treatment so that the fluid travels in the tubing to an extreme part of the body being treated, the fluid can then be released into an open bladder and / or reservoir. Subsequently, the fluid could then be controlled, via the controller and a pump and / or valves along the tubing for example, to flow or drain back into tubing to return the fluid back to the chiller / heater. Thus, the fluid flows through the system via a combination of closed and open fluid travel.

[0090] In an embodiment of the invention, the flow of fluid can be controlled by the control systems of the invention to utilize one or more pumps and / or one or more manifolds or valves for example, to release the fluid to tubing that is positioned near or adjacent to the most sensitive areas of the one or more parts of the body getting treatment. Accordingly, embodiments of the invention can provide fluid flow to one or more regions of the glove or boot while limiting fluid flow to one or more other regions of the glove or boot.

[0091] In accordance with the embodiments of the invention, wearing the glove while actively cooling or heating using the features of device 1, a user is able to maintain dexterity while using her / his hands for example, to use an electronic device, eat or drink, or read a book, without impacting the cooling or heating process.

[0092] In an embodiment, the cooling or heating device 1 can be used with one or more boots for example shown in Figs. 23A-23D, that will interface directly with the cooling or heating device 1 via inlet and outlet tubing and connectors, which can be similar to the tubing and connectors used for the gloves 20. These tubes will have a length that allows them to connect with the cooling unit while a user is wearing each boot, and avoid the tube length to be under excessive tension, or a nuisance to the user performing normal tasks. The tubes will connect to the boots at an inlet and outlet to one or more bladders / reservoirs that will deliver fluid towards for example the base of the user’s foot, and one or more channels in the boot will allow the fluid to travel to the region of one or more toes and to the tip of each toe, and return back towards the boot outlet to return to the cooling or heating device 1 .

[0093] In an example, the boot can also include a base that allows the bottom of the user’s foot to be in contact with a boot bladder, but avoid putting their weight on the bladder, forexample though use of one or more support structures, for example one or more mini columns that maintain structure when a user’s weight is on it.

[0094] In a further example, the boot can include one or more channels similar to channels 26, extending through one or more regions of the sole and / or midsole and / or upper structure of the boot to allow the fluid to cool and / or heat one or more regions of the boot and thereby one or more regions of the user’s foot. For example, channels 26 can extend in a toe region of the boot but not extend in a heel region of the boot. It should be appreciated that one or more of any region of the boot can include or not include channels 26 so that a temperature of any region of the boot can be controlled. Advantageously, by incorporating the channels 26 into the sole of the boot, the fluid flowing through the channels 26 is not subjected to pressure when the user stands and flow of the fluid through the channels 26 can be properly maintained.

[0095] Similar to the glove 20, one or more portions of the boot can be made from a weaving material that includes coolant channels 26 incorporated into the weave. According to an example, the weaving material including the channels, can be incorporated into only one or more the regions of the boot for which heating and / or cooling is desired.Accordingly, the size or bulk and / or weight of the boot can reduced which will increase the comfort and maximize the mobility of the user while wearing the boot.

[0096] In an embodiment, fluid will enter the boots in a similar manner as the gloves, entering the boot inlet and travelling to a manifold-like component and splitting in several directions to cover one or more desired regions of the user’s foot, for example in a curtainlike manner, and proceeding to the base of the boot, and travelling to the bladder outlet andreturning to the cooling or heating device 1 . As with the glove, the bladder can be on one or both sides of the boot, and the bladder design may be different or the same on the two sides.

[0097] Wearing the boots while actively cooling or heating, a user is able to use her / his feet for example, walk short distances without impacting the cooling or heating.

[0098] In one or more embodiments of the invention, the fluid inlet and outlet tubes extending from the device 1 to the article worn by the user of embodiments of the invention, for example glove and / or boot, are connected to an appropriate connectors integral with the article and the tubing associated with the article. The connectors of the article can comprise a connector port securely housing the connectors for both the cool fluid path and the warm fluid path. The connector port can prevent the connectors and tubes from movement which will facilitate fast and accurate connection for the tubes.

[0099] The tubing can be color coded to help with appropriate connections between the cooling fluid flow paths and the warming fluid flow paths. Alternatively, the connections for the cooling flow path and the warm fluid flow path can be different from each other to prevent incorrect connection between the different flow paths.

[0100] In one or more embodiments of the invention, the devices, systems and structures of the invention can control the temperature of each body part that is being treated independently. For example, if both hands are being treated, the temperature of the fluid flowing through each glove can be different from each other. Accordingly, embodiments can include separate fluid flow paths, tubes, coolant, reservoirs, and / or controller systems for each glove. In accordance with these advantageous features, for example, dominant and non-dominant hands can be at different starting points and may need different levels of cooling or heating to attain the same target temperature point.

[0101] Fig. 9 is a schematic view of a system 100 including an electronic device, such as a user device 105 communicatively connected to an apparatus, such as the cooling or heating device 1, according to an embodiment of the present disclosure. Notably, the user device 105 can be communicatively connected via a network 150, to a second electronic device, such as a server, that is a networked device 120. The devices can be connected via a wired or a wireless network. The connection between, for example, the user device 105 and the server can preferably be via the wireless network. In one embodiment, the user device 105 can be responsible for obtaining data from the cooling and heating device 1 and transmitting the data over the communication network 150 to the networked device 120.

[0102] An application may be installed or accessible on the user device 105, for executing the methods described herein and control the operations of the cooling and heating device 1. The application may also be integrated into an operating system (OS) of the user device 105. The user device 105 can be any electronic device such as, but not limited to, a mobile device. The mobile device may comprise any electronic device that may be transported and operated by a user, which may also provide remote communication capabilities to a network. Examples of remote communication capabilities include using a mobile phone (wireless) network, wireless data network (e.g., 3G, 4G, 5G or similar networks), Wi-Fi, Wi-Max, or any other communication medium that may provide access to a network such as the Internet or a private network. Examples of mobile devices include mobile phones (e.g., cellular phones), PDAs, tablet computers, net books, laptop computers, personal music players, hand-held specialized readers, wearable devices (e.g., watches), vehicles (e.g., cars), a smart-television, an interactive screen, an loT (Internet of things) device, or the like.The mobile device may comprise any suitable hardware and software for performing suchfunctions, memory, and may also include multiple devices or components (e.g., when a device has remote access to a network by tethering to another device - i.e., using the other device as a relay - both devices taken together may be considered a single mobile device).

[0103] For example, the user device 105 can be a mobile phone in possession of the user of the cooling or heating device 1. The cooling or heating device 1 can track and / or monitor via various sensors, parameters of the treatment performed by the cooling or heating device 1 and save the obtained information and / or data. The obtained information and / or data can be stored for example in memory provided with the device 1, a peripheral device, or transmitted to the cloud and stored. For example, the obtained information and / or data may be stored in the memory provided with the device in an event that it is not saved to the cloud or a remote server. The obtained information and / or data may include specific performance data which may be used, for example, during troubleshooting should the cooling or heating device 1 fail during operation and needs to be fixed. In addition to or alternatively, the device 1 can transmit the obtained information and / or data to the user device 105 to be stored therein or sent to the cloud.

[0104] The user device 105 can receive the data from the cooling or heating device 1 and track and / or analyze the received data. The cooling or heating device 1 can also be communicatively connected to the networked device 120 and the cooling or heating device 1 can transmit the data to the networked device 120. As an example, the user device can track neuropathy symptoms associated with the data received from the device 1 and can transmit this information to medical professionals monitoring the user.

[0105] The user device 105 can also be configured to transmit data and instructions to the cooling or heating device 1. For example, as discussed above, the cooling or heating device1 can include a plurality of sensors to detect for example, a temperature of the fluid, a fluid flow rate, a temperature of the user’s skin, possible fluid leakage, etc. Accordingly, in an embodiment of the invention, the user can monitor and / or track and / or control and / or adjust the various parameters and / or settings and / or functioning of the cooling or heating device 1 by way of the user device 105. Further, the user device 105 Accordingly, the user device 105

[0106] That is, the user interface of the user device 105 can include any combination of input and output elements to allow a user to interact with and invoke the functionalities of the cooling or heating device 1.

[0107] In an embodiment, the networked device 120 can also transmit data and instructions to the user device 105 to relay to the cooling or heating device 1, or transmit directly to the cooling or heating device 1.

[0108] The device 1 can include a port on any external surface of the housing of the device 1, for example the front surface, so that a cable can be attached thereto, with the other end of the cable being connected to a computer to control and / or adjust each parameter, function, system, and / or methods of embodiments of the invention, in addition to the User Interface Display, and the user device 105. This allows someone to adjust user parameters or adjust any additional programming of parameters.

[0109] In embodiments, the computer can be a desktop, laptop, or server. The computer can perform the functions of the cooling or heating device 1 , and / or the user device 105 and / or the networked device 120.

[0110] The computer includes a CPU which performs the processes described herein. The process data and instructions may be stored in memory. These processes and instructionsmay also be stored on a storage medium disk such as a hard drive (HDD) or portable storage medium or may be stored remotely. Further, the claimed advancements are not limited by the form of the computer-readable media on which the instructions of the inventive process are stored. For example, the instructions may be stored on CDs, DVDs, in FLASH memory, RAM, ROM, PROM, EPROM, EEPROM, hard disk or any other information processing device with which the computer communicates, such as a server or computer.

[0111] Further, the claimed advancements may be provided as a utility application, background daemon, or component of an operating system, or combination thereof, executing in conjunction with CPU and an operating system such as Microsoft® Windows®, UNIX®, Oracle ® Solaris, LINUX®, Apple macOS® and other systems known to those skilled in the art.

[0112] In the computer, the hardware elements may be realized by various circuitry elements, known to those skilled in the art. For example, CPU may be a Xenon® or Core® processor from Intel Corporation of America or an Opteron® processor from AMD of America, or may be other processor types that would be recognized by one of ordinary skill in the art. Alternatively, the CPU may be implemented on an FPGA, ASIC, PLD or using discrete logic circuits, as one of ordinary skill in the art would recognize. Further, CPU may be implemented as multiple processors cooperatively working in parallel to perform the instructions of the inventive processes described above.

[0113] The computer also includes a network controller, such as an Intel Ethernet PRO network interface card from Intel Corporation of America, for interfacing with a network. As can be appreciated, the network can be a public network, such as the Internet, or a private network such as LAN or WAN network, or any combination thereof and can alsoinclude PSTN or ISDN sub-networks. The network can also be wired, such as an Ethernet network, or can be wireless such as a cellular network including EDGE, 3G, 4G, 5G wireless cellular systems. The wireless network can also be WiFi®, Bluetooth®, or any other wireless form of communication that is known.

[0114] The computer further includes a display controller, such as a NVIDIA® GeForce® GTX or Quadro® graphics adaptor from NVIDIA Corporation of America for interfacing with the display, such as a Hewlett Packard® HPL2445w LCD monitor. A general purpose I / O interface can interface with a keyboard and / or a mouse as well as an optional touch screen panel on or separate from the display. A general purpose I / O interface also connects to a variety of peripherals including printers and scanners, such as an OfficeJet® or DeskJet® from Hewlett Packard.

[0115] A general purpose storage controller can connect a storage medium disk with a communication bus, which may be an ISA, EISA, VESA, PCI, or similar, for interconnecting all of the components of the computer.

[0116] The cooling or heating device 1 can be transported by the user in a manner that allows the user to use their hands and to not be impeded by the weight, size, or operation of the cooling or heating device 1. The cooling or heating device 1 architecture will include provisions to evenly distribute the weight and volume of the system. The cooling or heating device 1 will connect to the user’s body in an ergonomic way, and account for users of various shapes, size and physical abilities.

[0117] The user should be able to carry the cooling or heating device 1 with them and not be impeded by it when sitting, standing, laying down, sleeping, riding in a motor vehicle,and walking around. It should also not affect their ability to set up for or receive chemotherapy treatment.

[0118] In one or more embodiments of the invention, there are several device interfaces that provide for the proper function of the cooling or heating device 1. For example, electrical adapters / connections. There can be several electrical connections required to ensure the cooling or heating device 1 receives power for as long as desired. For example, these connections are as follows: battery to cooling or heating device 1, AC adapter to cooling or heating device 1, and car power adapter to cooling or heating device 1.

[0119] Further, there is a method to connect the gloves and / or boot subsystems to the cooling or heating device 1, as well as a method to connect the gloves and / or boots subsystem tubing to the actual glove or boot, for example Swagelok. The connection is easy to make, and each connecting end is similarly coded, such as with the same color or the same basic shape.

[0120] There is an interface the user can access at all times to control the cooling or heating device 1 and ensure it is running in a way that is comfortable for the user. This mechanism, device or controller will be easily accessible by the user during operation and will not restrict or impede the user in any way.

[0121] In the preceding description, specific details have been set forth, such as a particular geometry of a processing system and descriptions of various components and processes used therein. It should be understood, however, that techniques herein may be practiced in other embodiments that depart from these specific details, and that such details are for purposes of explanation and not limitation. Embodiments disclosed herein have been described with reference to the accompanying drawings. Similarly, for purposes ofexplanation, specific numbers, materials, and configurations have been set forth in order to provide a thorough understanding. Nevertheless, embodiments may be practiced without such specific details. Components having substantially the same functional constructions are denoted by like reference characters, and thus any redundant descriptions may be omitted.

[0122] Various techniques have been described as multiple discrete operations to assist in understanding the various embodiments. The order of description should not be construed as to imply that these operations are necessarily order dependent. Indeed, these operations need not be performed in the order of presentation. Operations described may be performed in a different order than the described embodiment. Various additional operations may be performed and / or described operations may be omitted in additional embodiments.

[0123] Those skilled in the art will also understand that there can be many variations made to the operations of the techniques explained above while still achieving the same objectives of the invention. Such variations are intended to be covered by the scope of this disclosure. As such, the foregoing descriptions of embodiments of the invention are not intended to be limiting. Rather, any limitations to embodiments of the invention are presented in the following claims.

Claims

WHAT IS CLAIMED IS:

1. A system for supplying temperature controlled fluid to a garment worn by a user, the system comprising: a portable cooling or heating unit configured to control a temperature of a fluid that circulates through the cooling or heating unit; a heat exchange article to be worn by a user, the article including one or more channels within the article configured to allow the fluid to flow therethrough to circulate the fluid to one or more regions of the article; and tubing structurally connected to each of the portable cooling or heating unit and to the heat exchange article, the tubing providing a fluid pathway to allow fluid to flow between the portable cooling and heating unit and the heat exchange article in a fluid-tight manner, wherein at least one of the portable cooling and heating unit and the heat exchange article includes one or more sensors configured to monitor one or more parameters of the portable cooling and heating unit and the heat exchange article, wherein the portable cooling and heating unit includes processing circuitry configured to: receive, from the one or more sensors, the one or more monitored set of parameters, determine whether the one or more monitored set of parameters is within a predetermined range of a parameter setpoint, and upon determining the one or more monitored set of parameters is not within the predetermined range of the parameter setpoint, adjust a value of the one or more monitored set of parameters.

2. The system of Claim 1, wherein the heat exchange article includes at least one fluid channel located within the article, the fluid channel configured to allow the temperature controlled fluid to flow therethrough for transferring heat between the temperature controlled fluid flowing through the channel and the region of the user’s body adjacent the channel.

3. The system of Claim 2, wherein the one or more monitored set of parameters includes a temperature of the fluid flowing through at least one of the cooling and heating unit, the heat exchange article, and the tubing.

4. The system of Claim 3, wherein the heat exchange article is a glove configured to be worn on a user’s hand.

5. The system of Claim 4, wherein the at least one fluid channel includes a plurality of channels, each of the plurality of channels located at a different position within the glove.

6. The system of Claim 5, wherein the tubing includes a first tube and a second tube, the first tube connected to an outlet of the cooling and heating unit and an inlet of the glove, the second tube connected to an inlet of the cooling and heating unit and an outlet of the glove.

7. The system of Claim 1, wherein one or more of the sensors are positioned within the heat exchange article.

8. The system of Claim 1, wherein one or more of the sensors are positioned within the cooling and heating apparatus.

9. The system of Claim 1, wherein one of the monitored parameters is a temperature of the fluid flowing through the system, wherein the processing circuitry configured to increase or decrease the temperature of the fluid upon a determination that the temperature is not within the predetermined range.

10. The system of Claim 1, wherein one of the monitored parameters is a flow rate of the fluid flowing through the system, wherein the processing circuitry configured to increase or decrease the flow rate of the fluid upon a determination that the flow rate is not within the predetermined range.

11. The system of Claim 6, further comprising a manifold positioned with the heat exchange article, the manifold configured to guide the fluid flowing into the heat exchange article to a plurality of the channels positioned in at more than one region of the glove.

12. The system of Claim 11, wherein a plurality of channels are positioned in a respective plurality of finger regions of the glove.

13. The system of Claim 3, wherein the heat exchange article is a boot configured to be worn on a user’s foot.

14. A method for controlling a body temperature of a region of a body, the method comprising: determining with one or more sensors, one or more parameters associated with the region of the body; determining whether the one or more monitored set of parameters is within a predetermined range of a parameter setpoint; and upon determining the one or more monitored set of parameters is not within the predetermined range of the parameter setpoint, adjusting a value of the one or more monitored set of parameters, wherein one of the one or more set of parameters is a temperature of a fluid, the fluid flowing between a cooling and heating unit configured to control a temperature of a fluid that circulates through the cooling or heating unit and a heat exchange article worn by the user on a part of the body of the user.

15. The method according to Claim 13, wherein the heat exchange article is a glove worn by the user, the glove includes one or more channels within the glove configured to allow the fluid to flow therethrough to circulate the fluid to one or more regions of the glove.

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