The present invention is generally directed toward a device for measuring the temperature of an extremity of the anatomy of a subject, and more particularly to monitoring the foot temperature of a subject with diabetes or another condition causing relatively low blood circulation and temperature in the extremities of the subject.
Some diseases, disorders, syndromes, and conditions cause decreased blood flow to the extremities of the body. One such disease is diabetes mellitus. A diabetic patient has abnormal (high) glucose levels in the blood, affecting its flow to the lower extremities, such as the feet and toes. The decreased blood flow can lead to serious complications, including numbness, neuropathy, pain, and even tissue damage, ulceration, amputation, and worse. The Mississippi Department of Health said the Magnolia State ranked second in the nation for prevalence of diabetes in 2012. Accordingly, four of every 1,000 deaths in Mississippi resulted from complications of the disease.
There is a need for a means of monitoring the blood flow or other related symptoms of diabetic complications in a subject's lower extremities to prevent or lessen the damage to tissue in these subjects.
The goal of the present invention is to address the shortcomings of the prior art and to provide a device for measuring the temperature directly (and blood flow indirectly) of a lower extremity of a subject in need thereof. Accordingly, in one aspect, the present invention provides a device for measuring the temperature of at least one foot of a subject in need thereof comprising: a structural platform, a plurality of temperature sensors, a power supply, and a control box. The structural platform may be a mat, pad, or wearable pad. The plurality of temperature sensors may be thermistor sensors. The power supply may be a battery. The control box further comprises a processor and a memory storage device. The control box may further comprise a transceiver.
In another aspect, the present invention provides a method of preventing tissue damage in a subject in need thereof comprising the steps of measuring the temperature of a lower extremity of the subject in need thereof with a plurality of temperature sensors as a first data set, processing the first data set collected from the plurality of temperature sensors, measuring the temperature of the lower extremity of the subject in need thereof with the plurality of temperature sensors as a second data set, processing the second data set collected from the plurality of temperature sensors, analyzing the first and second data sets, providing an instruction for a user or caregiver to take a remedial action based on the results of the analyzing step.
Further advantages of the invention will become apparent by reference to the detailed description of preferred embodiments when considered in conjunction with the drawings:
The following detailed description is presented to enable any person skilled in the art to make and use the invention. For purposes of explanation, specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that these specific details are not required to practice the invention. Descriptions of specific applications are provided only as representative examples. Various modifications to the preferred embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the scope of the invention. The present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.
Referring now to
In various examples, the electronic temperature measuring device 1 may be configured to measure the temperature of a subject's foot. As best shown in
The temperature measuring device 1 may further include a right foot placement guide 12 and a left foot placement guide 13. The right and left foot placement guides may be configured to assist a user/subject to properly place the foot/feet over the plurality of temperature sensors 4-11. In other words, the plurality of temperature sensors 4-11 may be located such that one or more of the plurality of temperature sensors 4-11 are positioned in contact with a subject's foot while a subject is standing or sitting or otherwise has the subject's foot or feet in contact with the temperature measuring device 1 as illustrated by the guide 12, 13.
As shown in
Where the foot temperature measuring device 1 includes a foot pad 15 or a pair of foot pads 15, the foot temperature measuring devices 1 may be configured to be integrated into, positioned on, and/or coupled with insoles 16 (e.g., wearable insoles for shoes and other footwear) (see
In various applications, the temperature sensors 4-11 need to be positioned and/or held within sufficient proximity to the subject's foot for a predetermined length of time in order to allow the temperature measuring device 1 to take an accurate reading. Thus, while a subject can satisfy the proximity and temporal duration requirements of the foot temperature measuring device 1 by standing on or placing their foot/feet on top of the foot temperature measuring device 1 while in a seated position, some subjects in need thereof may not be able to stand or sit up on their own or for very long comfortably or may prefer a wearable temperature measuring device 1. For these subjects, the foot pad 15 of the temperature measuring device 1 being integrated into a wearable article may allow the temperature measuring device 1 to be held against the foot/feet of the subject for at least the required temporal duration. The proximity and temporal duration requirements may be accomplished by manually holding or by employing straps (not shown) to hold the foot pad 15 of the temperature measuring device(s) 1 to the bottom of the subject's foot/feet or by using a wearable article (e.g., an insole 16 or a sock 17) to hold the foot pad 15 to the bottom of the subject's foot/feet. Integrating the temperature measuring device 1 into or coupling the temperature measuring device 1 with a wearable article (e.g., an insole 16 or a socket 17) may also allow for monitoring temperature of the subject's foot/feet during times of sleeping. In all cases, the temperature measuring device 1 is comfortable to the user/subject in need thereof while using the temperature measuring device 1.
As illustrated in
The temperature monitoring device 1 may further include a protective coating 20. The protective coating 20 may be positioned over the instrument surface 18 of the foot temperature measuring device 1 and/or may be positioned over each of the individual temperature sensors 4-11. The protective coating 20 may be configured to protect each of the temperature sensors 4-11 from moisture (e.g., moisture on the foot/feet from after a bath/shower or from perspiration). It has been found that the plurality of temperature sensors 4-11 are more accurate when kept free of moisture such that the protective coating 20 may increase accuracy of readings. To prevent moisture from wet feet, the plurality of temperature sensors 4-11 may be protected from moisture by a protective coating 20.
Each of the plurality of temperature sensors 4-11 may be substantially flat. Providing the temperature sensors 4-11 as flat sensors may provide the user/subject with a comfortable experience while standing on or wearing the foot temperature measuring device 1. For example, each of the temperature sensors 4-11 may be configured as a thermistor-type temperature sensor 19. Thermistor-type temperature sensors 19 may be configured to provide accuracy in a variety of environmental conditions. In other examples, each of the temperature sensors 4-11 may be a thermocouple, a resistance thermometer, or known other electrical temperature sensor such as infrared body thermometers, temperature strips, digital heat sensors, infrared wave sensors, and basal thermometers. It will be understood that any type of temperature sensor may be used without departing from the scope of the present disclosure.
The plurality of temperature sensors 4-11 may be positioned in any pattern or order configured to achieve a substantially accurate temperature gauge of the subject's foot/feet. For example, as shown in
Referring now to
As illustrated in
In application, the plurality of temperature sensors 42-58 in various locations is configured to allow temperatures to be taken dynamically which may increase the accuracy of the temperature reading. To perform this dynamic reading, the temperature monitoring device 1 will first check and verify if the user's foot is covering a minimum of four sensors, as discussed in more detail elsewhere herein. Upon verification, all of the covered sensors will independently record the temperature and work together to collectively output the foot's temperature average. This type of dynamic reading and various locations of the sensors are configured to provide the opportunity to capture a reading from a varying range of foot sizes versus the standard one-foot size.
As introduced above, the sensors assembly 40 further includes a plurality of capacitive sensors 70-78. As shown in
Referring now to
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The temperature measuring device 1 may be configured to save power in order to conserve battery life, when so provided. For example, the temperature measuring device 1 can be kept in an “off” or low power “sleep” mode under normal conditions. In various examples, the temperature measuring device 1 may “wake up” periodically to an “on” condition at predetermined (programmed time periods stored within a memory 3a) in order to take a reading before returning to the “off” or “sleep” mode. In other examples, the temperature measuring device 1 may be configured to trigger an “on” condition when the user/subject provides a triggering amount of pressure (trigger pressure can be programmed and stored within the memory 3a) so that a reading measurement is only taken when the user/subject is well within the proximity sufficient for an accurate reading. Where the temperature measuring device 1 is configured to trigger an “on” condition when provided with a triggering amount of pressure, the device 1 may further include a predetermined time duration between data collection (time period can be programmed and stored within the memory 3a). For example, if the user/subject is standing on a platform 14 of the device 1 while performing some task, the device 1 can be triggered to only make a reading every two minutes, five minutes, 10 minutes, 15 minutes, etc.
Each of the plurality of temperature sensors 4-11, 48-52 may be in electric communication with the controller 3. An output of an electronic signal carrying the temperature reading information is transferred from the plurality of temperature sensors 4-11, 48-52 to the controller 3. The controller 3 processes (via a processor 3b, microcontroller, CPU, or similar device well-known in the art) the electronic signal from the plurality of temperature sensors 4-11, 48-52 to extrapolate the temperature reading from each of the plurality of temperature sensors 4-11, 48-52. The temperature readings form the plurality of temperature sensors 4-11, 48-52 are stored in a memory 3a that is in electronic communication with the processor 3b. In various examples, the temperature readings data are given a time and date stamp according to their time of creation, and this information is stored in association with the temperature readings data.
The memory 3a may be a removable memory storage device, such as a flash memory device (an SD card, a USB memory storage device, or the like). The memory 3a can be accessed by the processor 3b in order to transfer the data stored therein to another computing device, as discussed in more detail elsewhere herein. The method of transfer can be any known method within the field of medical devices. For example, the data can be recalled and transferred to a hardware device, such as a flash memory device (an SD card, a USB memory storage device, or the like) or a portable companion device 100 (see
The foot temperature measuring device 1 may be integrated directly with a doctor's office or medical establishment (e.g., a hospital or nursing home) by an Internet connection or a direct network connection to transfer the captured data directly to the computing device(s) thereof for convenient analysis by caregivers. In various examples, the data may be transferred to a handheld computing device (e.g., a smartphone or tablet) or to a portable companion device 100 with an app for collecting, analyzing, and/or storing the data.
Referring now to
As illustrated in
A base 120 may be configured to at least partially receive the portable companion device 100. For example, the base 120 may define a receiving space 122 configured to receive the portable companion device 100. In various examples, when the portable companion device 100 is received by the base 120, the portable companion device 100 may be electrically coupled with the base 120 to charge the power source 112. The base 120 may further be configured to be in wireless communication with the portable companion device 100. For example, a locator button 124 may be positioned on the base 120. When the locator button 124 is actuated, the base 120 may be configured to communicate with the portable companion device 100 to indicate the location of the device 100 (e.g., via auditory or visual feedback).
The portable companion device 100 may include a speaker 130, or other auditory feedback component. The speaker 130 may be configured to provide feedback to a user regarding the temperature reading or to provide a location of the device 100 to a user. A second speaker 132 may be positioned on the base 120. However, it is contemplated that the base 120 may be used without the second speaker 132 without departing from the scope of the present disclosure.
The portable companion device 100 may further include a light source 136 configured to provide visual feedback to a user. For example, the light source 136 may be an LED configured to provide visible flashing messages to a user. The portable companion device 100 may further include a tactile feedback component (not shown) configured to provide vibratory alerts to a user. Each of the light source 136 and the tactile feedback component may be configured to sync with the tactile feedback component 90 and the visual feedback component 92 of the temperature monitoring device 1 or may be operated independently from the visual and tactile feedback components 90, 92. In various examples, the base 120 may further include a second light source 140 configured to operate in conjunction with the light source 136 of the device and/or the visual feedback component 92 of the temperature monitoring device 1. However, it is contemplated that the base 120 may be used without the second light source 140 without departing from the scope of the present disclosure.
Data stored within the portable companion device 100 may be protected via a user credential requirement (e.g., a passcode or PIN entered into the portable companion device 100. In other examples, the data may be protected using a biometric passcode configured to prompt verification of a user's footprint via the plurality of capacitive sensors 70-78. Because capacitive sensors work by using arrays of tiny capacitor circuits to collect data, by creating a large enough array of capacitors (e.g., the plurality of capacitive sensors 70-78), an accurate and highly detailed image of the ridges of a footprint (much like a fingerprint) can be created from the electrical signals. Additionally, the capacitive sensors 70-78 may be configured to aid the temperature sensors 42-58 in checking for a proper circuit (or blood flow) within the limb. In the event that there is little to no circuit being detected by the capacitive sensors 70-78, the portable companion device 100 may be configured to provide an alert to the user urging the user to contact their physician immediately as the mat does not detect a circuit.
It has been found that a subject's lower extremity temperature correlates well with blood flow where a decrease in blood flow relates to a decrease in temperature of a subject's foot. For example, a drop of four degrees Fahrenheit from a baseline temperature in one or both feet of a subject may indicate a period of decreased blood flow that could cause tissue damage complications for the subject's lower extremities if not acted upon. A baseline temperature may be an average baseline temperature preprogrammed into memory 3a, or it may be a personalized baseline temperature that may be programmed into memory 3a for the user/subject using the device 1. Therefore, the temperature data captured can be used by a caregiver of the subject, such as a nurse or doctor, to monitor the health of the subject and/or prescribe preventive/remedial action or corrective action based on the analysis of the transferred data. The data captured can be processed and stored for each individual sensor of the plurality of temperature sensors 4-11, 48-52. The captured data can also be processed to provide an averaged temp for all sensors for one or both feet of the subject. The data captured can be processed to glean trends in temperature and blood flow for each foot and/or for each sensor.
By monitoring the temperature of the lower extremities of a subject, a foot or a portion thereof that is experiencing periods of lower temperature and lower blood flow can be found before tissue damage and ulceration occurs. The foot temperature measuring device 1 may act as an early warning device and, thereby, may provide for a prevention of complications of diabetes, low blood flow, and/or low temperature of a lower extremity. In addition to using the data captured to diagnose and take remedial action(s), the data can alert the user/subject in need thereof by performing an audible or visual alarm when the temperature reading of any foot or individual temperature sensor falls below the baseline temperature.
The foot temperature measuring device 1 is convenient to use and care for. The foot temperature measuring device 1 is light weight, mobile, and easily transportable. The foot temperature measuring device 1 is waterproof for cleaning. The platform 14 can be cleaned by wiping away soiling. Wearable forms are also capable of cleaning with water. For example, the foot pad 15 of the insole 16 may be removed from shoes or other footwear for cleaning and/or the foot pad 15 of the sock/hosiery-type articles 17 may be hand-washable with waterproof sealing of all electronic components and/or removable electronic components.
In some examples, the device 1 may be configured to determine a body mass index of a user/subject with mass/weight scales built into the platform 14 of the device 1 when coupled to a data for the user's/subject's height data (which may be preprogrammed into the memory 3a). The device 1 may also have a percent body fat measurement capability. In various examples, the device 1 may be configured to integrate with other health apps, platforms, and systems. Alternative embodiments include providing a plurality of temperature sensors 4-11, 48-52 for placement on a flat surface or directly on the user's/subject's skin surface or sock/hosiery article of the foot bottom.
The terms “comprising,” “including,” and “having,” as used in the claims and specification herein, shall be considered as indicating an open group that may include other elements not specified. The terms “a,” “an,” and the singular forms of words shall be taken to include the plural form of the same words, such that the terms mean that one or more of something is provided. The term “one” or “single” may be used to indicate that one and only one of something is intended. Similarly, other specific integer values, such as “two,” may be used when a specific number of things is intended. The terms “preferably,” “preferred,” “prefer,” “optionally,” “may,” and similar terms are used to indicate that an item, condition or step being referred to is an optional (not required) feature of the invention.
The invention has been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention. It will be apparent to one of ordinary skill in the art that methods, devices, device elements, materials, procedures and techniques other than those specifically described herein can be applied to the practice of the invention as broadly disclosed herein without resort to undue experimentation. All art-known functional equivalents of methods, devices, device elements, materials, procedures and techniques described herein are intended to be encompassed by this invention. Whenever a range is disclosed, all subranges and individual values are intended to be encompassed. This invention is not to be limited by the embodiments disclosed, including any shown in the drawings or exemplified in the specification, which are given by way of example and not of limitation.
While the invention has been described with respect to a limited number of embodiments, those skilled in the art, having benefit of this disclosure, will appreciate that other embodiments can be devised which do not depart from the scope of the invention as disclosed herein. Accordingly, the scope of the invention should be limited only by the attached claims.
All references throughout this application, for example patent documents including issued or granted patents or equivalents, patent application publications, and non-patent literature documents or other source material, are hereby incorporated by reference herein in their entireties, as though individually incorporated by reference, to the extent each reference is at least partially not inconsistent with the disclosure in the present application (for example, a reference that is partially inconsistent is incorporated by reference except for the partially inconsistent portion of the reference).
This application is a continuation-in-part of U.S. application Ser. No. 15/387,376 to Jordan Barber et al. filed on Dec. 21, 2016, which claims priority to U.S. Provisional Application No. 62/314,098 to Jordan Barber et al. filed on Mar. 28, 2016, the contents of which are incorporated herein by reference in their entirety.
Number | Date | Country | |
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62314098 | Mar 2016 | US |
Number | Date | Country | |
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Parent | 15387376 | Dec 2016 | US |
Child | 17373374 | US |