Devices and methods for monitoring skin temperatures on a foot

Abstract

A non-wearable device for monitoring skin temperatures on a foot comprising a sole, sides, an instep, ankles and toes is provided. The device includes a base for receiving and supporting the sole of the foot, an upper part positioned above the base and configured to at least partially surround an upper part of an inserted foot, and a plurality of contact temperature sensors arranged on at least one of the base and the upper part, the plurality of sensors configured to measure temperature at a plurality of locations on the foot, including at least one location selected from: sides of the foot, tips of the toes, top of the toes and the instep.

Description

Devices and Methods for Monitoring Skin Temperatures on a FootField of the invention

[0001] The present disclosure relates to devices and methods for monitoring foot temperature, and more particularly to a device for measuring skin temperature at multiple locations on a foot including one or more of the sides(including the back / heel), tips of toes, top of toes, and instep to detect inflammation and possible ulcer development.Background

[0002] Diabetes is a chronic condition affecting millions of people worldwide. One of the most serious complications of diabetes is diabetic foot ulcers, which can lead to infections, amputations, and reduced quality of life. Early detection and prevention of foot ulcers is crucial for managing this complication effectively. Temperature monitoring of the feet has emerged as a promising approach for identifying areas at risk of ulceration before visible signs appear.

[0003] Current methods for foot temperature monitoring typically focus on measuring temperatures on the sole of the foot. This is often done using handheld infrared thermometers or specialized mats with embedded temperature sensors. While these approaches can provide useful information, they have limitations in their ability to capture temperature data from other areas of the foot that are also prone to ulceration. Ulcers on the sole of the foot typically only account for less than 50% of all ulcers.

[0004] Many existing devices for foot temperature monitoring also require manual measurements at specific points on the foot. This can be challenging for patients with limited mobility or visual impairments, for example, the elderly and / or obese. Additionally, manual measurements may not provide consistent or comprehensive coverage of all relevant areas of the foot, and requiring manual work to log and track by the patient. Some automated systems have been developed, but these often focus solely on plantar (sole) temperatures and may miss potential issues on other foot surfaces.

[0005] Another challenge with current foot temperature monitoring methods is achieving good contact between temperature sensors and the varied contours of the foot. Rigid sensor arrays may not conform well to individual foot shapes, potentially leading to inaccurate or incomplete temperature readings. This is particularly problematic for areas like the tops and sides of toes, which can have complex geometries.

[0006] Many existing foot monitoring devices are designed for clinical use ratherthan regular home monitoring by patients. This can limit the frequency of temperature measurements and delay the detection of developing foot problems. There is a need for user-friendly devices that encourage consistent, long-term monitoring as part of a patient's daily routine.

[0007] It has been appreciated that a device is needed that overcomes one or more of these. Further objectives, features and advantages are described in the detailed description below with reference to the appended drawings.Summary

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description.

[0009] The present disclosure relates to skin temperature monitoring for the detection of foot ulcer onset and devices and methods for such monitoring. Patients with long-term diabetes, peripheral neuropathy, peripheral artery disease and / or foot deformations, as well as patients with rheumatoid arthritis and Charcot feet are at risk of diabetic foot ulcers. Patients themselves often detect these ulcers too late, sometimes because they have lost protective sensation (e.g., neuropathy, nerve damage). It has been shown that temperature monitoring with hand thermometers can reduce ulcer incidence with 30% to 90%. Temperature monitoring has been included in global (and most local) clinical guidelines, but is seldomly implemented because it is often not feasible for patients who are often elderly and / or obese to manually measure temperatures each day at a minimum of 6 locations per foot, to maintain a manual log and to determine when to contact a healthcare professional (e.g., when they find a difference between corresponding locations between left and right foot for at least two consecutive days of 2.2 °C / 4° F).

[0010] As discussed in the background, existing solutions for this problem have focused on automating measurements of skin temperatures on the sole of the foot, and in some cases sending temperature data to a cloud environment, where automated and / or manual analysis takes place. Subsequently patients and / or healthcare professionals (HCPs, typically podiatrists) receive a message or call that signs of ulcer onset have been detected, after which the HCP and patient determine an intervention, for example, offloading by taking rest or getting better fitting shoes / insoles. Other solutions are wearable (e.g., socks or insoles) which can be effective in taking measurements but are complicated and expensive to produce, and wear out quickly due to the heavy use and need to wash after wearing.

[0011] The devices and methods hereinafter described can efficiently and effectively take multiple contact measurements on different surfaces of a foot, using a semi-open platform formed of a base and upper part with contact sensors. The devices are sufficiently open for a user to easily place their foot or feet into the device, and then the device is able to at least partly close around the inserted foot (either through manual movement, pressure or automatically) to make contact between the sensors and the foot. The device can then measure temperatures at multiple locations on the skin of both feet at locations prior art devices could not reach, for example, high-risk areas prone to ulcers such as the tips and tops of the toes and sides of the feet (including the back / heel), or medium risk areas such as the instep. Monitoring such areas allows for being alerted to a much larger percentage of potential ulcer formations than in past devices, and doing the monitoring through a (non-wearable) device which the user can easily and quickly place each foot into for the measurement can help to increase the lifespan and decrease the maintenance needs of the device itself.

[0012] After temperature measurements have been taken, the devices and methods can compare between corresponding locations on both feet and / or compare to earlier measurements. Data can be transferred to the cloud through wireless or wired communication by the device. Analysis cantake place on the device or in the cloud. When patterns in the temperature measurements are detected that indicate an increased risk for complications, the user and / or caregiver and / or healthcare professionals) receives a warning signal, either on the device or through an (electronic) communication or information system (e.g., text message, phone call, web portal, app, electronic health record, etc.). In some cases, the device or the electronic information system can also analyse usage data (e.g., monitoring adherence) and prompt the patient to keep monitoring, for example, by sending reminders, reports, gamification or social stimuli (such as competing with other users for high scores).

[0013] Thus, the devices and methods hereinafter described provide a simple, but effective way to monitor skin temperature on multiple regions of feet for early detection of foot ulcer onset even in locations which past devices could not monitor. This leads to the possibility to perform interventions and / or treatment which may limit or reverse the development of such ulcers.

[0014] According to a first aspect, a device for monitoring skin temperatures on a foot comprising a sole, sides, an instep, ankles and toes is provided. The device includes a base for receiving and supporting the sole of the foot, an upper part positioned above the base and configured to at least partially surround an upper part of an inserted foot, and a plurality of temperature sensors arranged on at least one of the base and the upper part, the plurality of sensors configured to measure temperature at a plurality of locations on the foot, including at least one location selected from: sides of the foot, tips of the toes, top of the toes and the instep.

[0015] Such a device enables comprehensive temperature monitoring of multiple areas of the foot beyond just the sole, allowing for detection of potential ulcer formation in a wider range of locations compared to conventional or prior art devices. By measuring temperatures at additional locations such as the sides of the foot (which could include the heel), tips and / or tops of toes, and / or the instep, the device can provide more complete detection of temperature anomalies indicative of ulcer onset, and in some cases detect such anomalies at an earlier stage than prior art devices, allowing for earlier treatment and / or mitigation strategies.

[0016] According to an embodiment, the base comprises flexible material and / or a flexible surface. Optionally, the base further comprises heat conducting pads (e.g. copper pads). The use of flexible materials and / or a flexible surface in the base allows the device to better conform to the shape of the foot, improving contact between the sensors and the skin for more accurate temperature measurements. The flexible material and / or a flexible surface can also help to wrap partially around sides, back and / or toes to have further contact for sensing. Further, flexible material and / or a flexible surface can help to avoid damage or injuries to the foot when using the device. Using heat conducting pads (e.g., in combination with the flexible material and / or flexible surface) can help to ensure that the majority of the flexible material / surface gets sampled. For example, when a toe only partially touches a heat conducting pad, this pad will still reach (almost) the temperature of the skin, since thermal conductance between skin and heat conducting pad is much higher than between air and the conducting pad and the sensor will be able to sense the temperature despite only a partial touch.

[0017] Alternatively, the base could be a rigid substrate, for example, flat or curved along the foot. Such an embodiment could be useful to provide a more stable platform for receiving a foot and could reduce the complexity and therefore cost of the device.

[0018] According to an embodiment, the base flexes partially around at least one side of the foot when the sole is on the base to position at least one sensor to sense a skin temperature on the side of the foot. This can be one or more of the lateral sides, the back and / or the front (e.g., toes). This flexing capability enables the device to measure temperatures on the sides of the foot without requiring separate rigid structures, simplifying the design while expanding measurement coverage and accommodating different sizes and shapes of feet.

[0019] According to an embodiment, the base comprises supports and a flexible surface comprising one or more of the plurality of sensors. Optionally, the supports are deformable and / or comprise one or more bands or springs to guide the flexing of the flexible surface partially around at least one side of the foot. In some embodiments, the supports are deformable, but still semirigid for providing support to the foot.

[0020] The combination of supports and a flexible sensor surface provides a balance between structural integrity and adaptability to foot shape, ensuring consistent sensor contact across various foot sizes and shapes. Partially deformable supports and / or the use of bands and / or springs allows for controlled flexing of the sensor surface, ensuring optimal sensor positioning while maintaining comfort for the user, and can help to ensure the base wraps at least partially around sides of the foot.

[0021] According to an embodiment, the flexible surface extends substantially planar with a top of the supports when no foot is on the base. This planar configuration when not in use provides a compact form factor for storage and allows for easy cleaning of the device between uses.

[0022] According to an embodiment, the flexible surface forms a receiving channel below a top of the supports when no foot is on the base. A pre-formed receiving channel can help guide foot placement and provide initial conformity to the foot shape, potentially improving measurement consistency across multiple uses. Such a configuration can also allow for wrapping around more of the sides (e.g., further up on the sides, possibly including back and / or front) of the feet for further measurement locations.

[0023] According to an embodiment, the base comprises a moveable platform and the flexible material is drawn at least partially around at least one side of the foot as the platform moves. Optionally, strings draw the flexible material at least partially around at least one side of the foot as the platform moves or tilts downward, and the flexible material comprises one or more sensors. Such strings could, for example, wrap around the back of the foot (e.g., heel, ankles) as the platform tilts down at the back, pulling flexible material comprising sensors up around the back of the foot. This moveable platform design with string-guided flexible material with sensors allows for dynamic adjustment of sensor positioning, potentially improving sensor contact with more of the foot, and measurement accuracy across a wide range of foot sizes and shapes.

[0024] According to an embodiment, the base is moveable to enable contact between the foot and the upper part for enabling sensing on at least one of: the sides of the foot, one or more ankles, tipsof the toes, top of the toes, one or more ankles, and the instep. Optionally, the base is tiltable from a receiving position to a sensing position.

[0025] The moveable design allows for a simple device into which a user can easily insert a foot, and enables sensing through a non-complex movement once inserted. Such a device is able to then measure temperatures at locations on the foot which were difficult or impossible for prior art devices to reach and measure. A moveable and / or tiltable base thus provides a simple mechanical solution for bringing sensors into contact with different areas of the foot, improving ease of use and potentially reducing device complexity and cost. Such mechanical movement is typically manually initiated, making the device less costly to produce and maintain (e.g., does not need batteries or a motor for movement). Alternatively, the moveable base (and / or upper part) could be moveable with electrical actuators, such as servo motors powered by batteries to move into contact with the foot. Such powered movement could help users with less strength and / or mobility.

[0026] According to an embodiment, the sensing position tilts the base such that the toes and at least part of the instep is in contact with the upper part. This tilting action can help to ensure good sensor contact with the toes and / or instep, areas that are helpful for early detection of diabetic foot ulcers but unable to be sensed in prior art devices.

[0027] According to an embodiment, the upper part is non-moving. A non-moving upper part can simplify device construction and improve durability and lifespan of the device while still allowing for comprehensive foot temperature measurements when combined with a moveable base.

[0028] According to an embodiment, the upper part is moved into an upper sensing position with the movement ortilting ofthe base. Optionally, the upper part is moved to the upper sensing position through one or more linkages as the base tilts from the receiving position to the sensing position. Coordinated movement ofthe upper part with the base can help to optimize sensor contact across multiple foot areas simultaneously, potentially improving measurement speed and consistency. Additionally, such movement of both parts allows for smaller movements of each of the base and upper part to come into the sensing position. The use of linkages can provide mechanical advantage in moving the upper part, allowing for precise control of sensor positioning with less user effort.

[0029] According to an embodiment, the base moves vertically into the sensing position. Optionally, the vertical movement ofthe base moves the upper part into an upper sensing position wherein the upper part is in contact with at least one of: the sides ofthe foot, tips ofthe toes, top of the toes, one or more ankles and at least part ofthe instep.

[0030] Vertical movement of the base can provide uniform pressure distribution across the foot during measurement, potentially improving measurement accuracy and user comfort. Additionally, such a configuration could help ease of use forthose that cannot easily rotate their ankles or have less foot mobility, allowing for a simple vertical movement into the sensing position. This coordinated vertical movement helps to provide comprehensive coverage of multiple foot areas in a single measurement action, simplifying the user experience while maximizing diagnostic potential.

[0031] According to an embodiment, the base and the upper part are connected by one or more links such that the upper part is moved toward the base when the base is moved into the sensing position. Optionally, the one or more links comprise one or more of a spring, arm, band, pulley orgear. Such links can help to allow for customized movement patterns of the upper part relative to the base, optimizing sensor contact for different foot shapes and sizes. Additionally, the links can help ensure that the movements into the sensing position can be made without requiring too much user force, allowing for use by those that have limited strength and / or mobility, for example, elderly, obese or sick patients.

[0032] According to an embodiment, the upper part comprises flexible material. Flexible material in the upper part allows for better conformity to the irregular surfaces of the foot, particularly around the toes and instep, improving sensor contact and measurement accuracy. Such flexible material can also help to ensure that the foot is not damaged during sensing, particularly on sensitive areas which may have or be developing ulcers, sores, warts or other foot issues.

[0033] According to an embodiment, the upper part comprises a plurality of adjacent fingers extending in an insertion direction. Optionally, each finger is able to at least partially adapt to contact the respective side, toe and / or the instep at the respective finger position. Further optionally, each finger is about 3-11 mm wide, preferably 4-6 mm wide and / or the plurality of fingers are 5-40 fingers, preferably 10-30 fingers, more preferably 10-20 fingers, most preferably 12-18 fingers. In some embodiments, each finger of the plurality of fingers is connected to and extends from an upper part base.

[0034] The finger design allows for independent adaptation to different toe lengths, shapes, configurations and sizes; and varying foot shapes, ensuring good sensor contact across a wide range of toe and foot anatomies. This specific finger width range and / or ranges of numbers of fingers can help to ensure that at least a certain number of fingers (e.g., two) will contact each toe, helping to balance the need for detailed temperature mapping of each individual toe with practical considerations of device complexity and cost. Connecting fingers to an upper part base provides structural support for the fingers while allowing them to flex and adapt to different foot shapes, thereby helping to improve measurement consistency and accuracy across users. Such fingers can help to enable larger deformations without stretching any flexible surface or resulting in changes in sensor alignment.

[0035] According to an embodiment, the device further comprises an ankle monitor configured to contact and take temperature measurements of one or more of the ankles in a sensing position. Optionally, the ankle monitor comprises first and second cushions comprising sensors, wherein the first and second cushions are moveable from a receiving position to a sensing position in which the first and second cushions contact the ankles. Further optionally, the first and second cushions are moved into the sensing position when the base moves from a receiving position to a sensing position. In some embodiments, the ankle monitor can also take measurements of the heel and parts of the foot adjacent to or surrounding the ankle.

[0036] The inclusion of ankle temperature monitoring expands the diagnostic capabilities of the device, potentially allowing for earlier detection of circulation issues that could lead to foot complications in places prior art devices could not reach or monitor. Moveable ankle cushions can allow for comfortable and accurate ankle (and / or surrounding ankle areas) temperaturemeasurements without requiring separate user actions, simplifying the measurement process while expanding measuring and / or diagnostic coverage.

[0037] According to an embodiment, the plurality of sensors are in a triangular grid formation. A triangular grid formation of sensors can provide more efficient coverage of the foot surface with fewer sensors compared to other configurations (e.g., a rectangular grid), potentially reducing device cost while maintaining measurement coverage and accuracy.

[0038] According to an embodiment, the plurality of sensors have a different sensor density depending on the part of the foot with which the sensor will come into contact. Varying sensor density allows for optimization of measurement resolution in critical areas (e.g., area more likely to develop ulcers or which need more measurements such as around the toes) while reducing unnecessary complexity in less critical areas, balancing diagnostic capability with device cost and complexity.

[0039] According to an embodiment, the upper part comprises a frame, a foam layer, and a biocompatible layer. Optionally, the upper part can also include an upper layer, further optionally the upper layer is rigid and / or non-stretchable, for example Thermoplastic Polyurethane (TPU). Optionally, the biocompatible layer comprises at least one of the plurality of sensors. Such a layered construction provides structural support (via the frame, and optional upper layer), comfort and flexibility via the foam layer, and direct and comfortable sensor contact with the skin via the biocompatible layer, providing a nice and comfortable user experience as well as measurement accuracy.

[0040] According to an embodiment, the frame comprises a main body and first and second arms connecting the main body to the foam and / or upper layer. The main body is typically rigid. Optionally, the arms are integrally formed with the main body, or can be formed separately and connected to the main body. Optionally, the first and second arms are flexible. The flexibility can be achieved through the materials used to form the arms, such as polyethylene or another flexible plastic, and / or through the thickness of the material. The flexibility can allow the arms to bend or twist inward toward each other, particularly toward their distal ends. While the arms can be flexible to allow for flexing inward and / or twisting, in other directions (e.g., vertical), the arms are less or not flexible. Further optionally, the frame is moveable and / or rotatable with respect to the base. The frame typically connects to a base through a rotatable connection to the main body, with the connection extending from the front side or optionally from a back side of the upper part. Optionally, the connection is through a rod extending along a rotation axis, allowing for front and back rotations perpendicular to the long axis of the foot when in use. This, can allow for bending and / or flexing of the arms, foam and biocompatible layer around the foot to ensure good sensor contact even with feet of varying shapes and sizes, including on deformities such as hallux valgus and hammertoes.

[0041] According to an embodiment, the foam has a symmetrical shape along the long axis of the foot, with curvature at the front end (e.g., around the toes) and curvature or hills extending on the lateral sides. Front end curvature can help to ensure good contact with the toes and end of the foot. The central curvature extending its longitudinal length forming a hills can be such that the tops of the hills touch the side of the foot at the metatarsal heads when in use. Optionally, the foam hasa thickness from about 30-40 mm (e.g., 35 mm) at the front (toe) end to about 30-50 mm at the back end with 5-15 mm difference between the thickness at the central curvature and the thickness at the hills, which can help to accommodate different size and shaped feet through compression of the foam and flexing of the arms to wrap the foam and biocompatible layer around the foot. The thickness of the foam can vary greatly in different embodiments, but would generally be in the range of 25-135 mm to ensure sufficient ability to compress around the foot but not make the device too large. The shape of the foam can also help avoid compression which could cause tenting, resulting is less optimal contact between the sensors and the foot. The foam shape as well as the movement, flexing and / or rotation of the frame and arms can help to ensure that sensors make good contact with feet of many shapes and sizes, including variations in the instep angle of the foot and contact with the sides of the feet at the metatarsal heads.

[0042] According to an embodiment, the frame connects to the base through the rod and pillars. Optionally, the frame moves up and down and rotates with respect to the pillars and base. Optionally, the frame only rotates, and the base provides any vertical and / or tilting movements toward the upper part to put feet into a sensing position. The vertical and / or tilting movements could be facilitated by a motor or could be manually controlled, or a combination of both. In some embodiments, movement could be controlled through the weight of the leg.

[0043] According to an embodiment, the foam is supported on a top side by the upper layer, extending between the arms. Optionally, the upper layer forms the connections to the arms in addition to or in alternative to the foam connecting to the arms. The upper layer can bend but resists in-plane stretching, thereby ensuring that movement of the frame and arms translates to movement of the foam and biocompatible layer around the foot. Examples of suitable materials for the upper layer are polymer foams and elastomeric sheets (e.g., Polyurethane, Ethylene-vinyl acetate, Polyvinyl chloride, Neoprene); woven polymer sheets (e.g., Polyethylene terephthalate or Nylon mesh); and thermoplastic thin sheets (e.g., Polyethylene , Polypropylene, Thermoplastic Polyurethane). Optionally, the foam itself extends between the arms, connecting directly to the arms and making for a more closed structure.According to an embodiment, the foam is surrounded by the biocompatible layer, which stretches or is formed around the foam on all but its top side (which is typically covered by the upper layer). The biocompatible layer includes one or more sensors for taking measurements on the foot. Optionally, sensor electronics are placed between the biocompatible layer and the foam. Optionally, the biocompatible layer is a thin layer, for example 10 pm to 100 pm thick, of thermoplastic polyurethane or a similar stretchable material to allow for movement and flexing with the foam around the foot, thereby ensuring good sensor contact and measurements despite movement and / or compression of the foam, biocompatible layer and other components of the upper part. According to an embodiment, each of the plurality of sensors is a contact temperature sensor. Contact temperature sensors are temperature sensors which come into physical contact with the object being sensed and typically use conduction to monitor changes in temperature. Contact temperature sensors can provide accurate localized temperature measurements (e.g., compared to non-contact infrared sensors), potentially improving the device's ability to detect early signs of ulcer formation.

[0044] According to a further aspect, an assembly comprising a first device according to any of the embodiments previously described, and a second device according to any of the embodiments previously described is provided. The first device and the second device are located adjacent to each other so that each of the first device and the second device receive one foot of a user.

[0045] This dual-foot assembly allows for simultaneous measurement of both feet, enabling immediate comparison between corresponding points on each foot for more effective irregularity detection. Additionally, the assembly allows for faster measurements as the feet do not need to be inserted one at a time. This helps to promote more frequent usage of the device, therefore promoting user compliance with a monitoring schedule and allowing for early detection of signs of ulcer formation, and therefore the ability to take preventative measures and / or treat the area.

[0046] According to an embodiment, the assembly is foldable. Optionally, the folding can be in a vertical and / or a horizontal direction. A foldable design improves portability and storage of the device, potentially increasing user adherence to regular monitoring routines, even when away from the home. Horizontal folding can allow for the upper part to fit complementary to the base, therefore protecting the device and making an overall more compact package when folded.

[0047] According to an embodiment, the assembly and / or device further comprises a display. Optionally, the display is located between the first device and the second device in an assembly. Such a display can provide immediate visual feedback to users, potentially improving their understanding of the usage of the device, their foot health status and encouraging regular use of the device. Such a display could also be used to prompt monitoring, for example having a different colour or shining an outward light to indicate to a user that they should come for a measurement. In some embodiments, the display could be used to guide or inform the user during the measuring process, for example, to inform the user of the progress and / or provide advice on foot placement. This can help the user feel more confident and comfortable in the usage as well as lead to more accurate sensing.

[0048] According to a further aspect, a method of monitoring skin temperatures on a foot is provided. The method includes providing the device of any of the preceding embodiments, positioning a first foot on the base of the device, bringing the upper part into contact with upper portions of the first foot, measuring temperature at the plurality of locations on the first foot using the plurality of temperature sensors, and storing the plurality of first foot measurements in a memory. The memory could be in the device itself, or located remotely, with the sensor data sent to the remote computer and / or memory.

[0049] Such a method enables comprehensive temperature monitoring of a foot, including areas not typically measured by conventional devices, potentially improving early detection of foot complications which could lead to sores or ulcers.

[0050] In some embodiment, temperature data analysis can be normalized with a baseline correction for temperature differences due to other diseases, e.g. peripheral artery disease. This baseline can be recorded at a moment when no signs of ulcer onset are present. It can also be updated overtime by filtering out slow changes in spatial temperature profiles.

[0051] According to an embodiment, the method further comprises positioning a second foot on the base of the device, bringing the upper part into contact with upper portions of the second foot, measuring temperature at the plurality of locations on the second foot using the plurality of temperature sensors, storing the plurality of second foot measurements in a memory, and comparing the first foot measurements with the second foot measurements to determine if there is variation. The storing in the memory and comparing steps can be performed at the device itself, for example, with a computer with processor and memory, or remotely with the data being transferred (e.g., through a wired or wireless connection) to a different location for storage and / or analysis. Measuring and comparing temperatures from both feet, particularly at similar positions of each feet, allows for detection of asymmetrical temperature patterns, which can be an early indicator of foot complications.

[0052] According to an embodiment, the method further comprises sending an alert if the variation is outside a range. Optionally, the range is preset or determined dynamically based on variations in measurements taken. Such an alert could be sent to the user, doctor, or another monitoring system. Alerts could be a simple message; a visual, tactile or audible alert; or another form for indicating a variation which should be addressed. Automated alerts can prompt timely intervention, potentially preventing the progression of foot complications. Dynamic range determination can account for individual variations in foot temperature patterns, potentially reducing false alerts while maintaining sensitivity to clinically significant changes.

[0053] According to an embodiment, the steps of taking first foot measurements and second foot measurements are done simultaneously with an assembly as previously described. Simultaneous measurement of both feet can reduce the total time required for monitoring, potentially improving user adherence to regular monitoring routines through a more efficient monitoring process.

[0054] According to an embodiment, the method further comprises providing visual and / or audible cues by the device to guide the user during monitoring and / or to remind the user to monitor. User guidance and reminders can improve the monitoring, as well as the consistency and frequency of monitoring, potentially leading to earlier detection of foot complications. The cues during use of the device can help to ensure that the user utilizes the device correctly, for example, guiding the user in proper foot placement, movement into a sensing position and / or to stay still for the length of measurement. Such cues can both help to improve measurements and help a user feel comfortable and confident in use.

[0055] According to an embodiment, the method further comprises sending temperature data for storage and / or analysis via a wired or wireless connection. Wired connection options may include USB, Ethernet, or serial connections. Wireless connection methods may incorporate technologies such as Wi-Fi, Bluetooth, Near Field Communication (NFC), cellular networks (e.g., 4G, 5G), Internet of Things (loT), or proprietary wireless protocols. The device may also support multiple connection methods, allowing flexibility in data transmission based on available infrastructure and / or user preferences. For instance, the device may default to a Wi-Fi connection when in range of a known network, but switch to cellular data transmission when Wi-Fi is unavailable. In some implementations, the device may include a removable storage medium, such as an SD card or USBdrive, allowing for physical transfer of data. This may be particularly useful in settings where wireless connectivity is limited or restricted, or may be less secure for transmitting sensitive medical data.

[0056] The connection method may also be designed to support secure data transmission, potentially incorporating encryption protocols to protect sensitive health information during transfer. Some embodiments may include automatic data synchronization features, where the device periodically uploads new measurement data to a cloud-based storage system or healthcare provider's database when a connection is available.

[0057] Additionally, the device may be compatible with smartphone applications, allowing users to transfer data to their personal devices for viewing, analysis, or forwarding to healthcare providers. This approach may leverage existing personal device connectivity options and user familiarity with smartphone interfaces. Remote data storage and analysis can facilitate long-term tracking of foot health and enable healthcare provider involvement in monitoring, potentially improving overall care management.

[0058] According to an embodiment, the method comprises error detection. This could be within a single measurement, for example, by identifying measurements with deviating convergence profiles (e.g., within the 10-20 seconds measurement time) from normal convergence (e.g., approximately a double exponential with a delay) as indicative of foot movement and thereby measurement error; or identifying differences in foot shape between the left and right foot as indicating an erroneous measurement. Error detection could also or in alternative be related to measurements overtime, for example, strongly deviating spatial temperature profiles within a foot from previous measurements which can be indicative of incorrect foot placement, foot movement, or otherwise erroneous measurements; and / or dissimilar foot shapes over time which indicate erroneous measurements. Such error detection can help to avoid false measurements, and any measurements identified as erroneous can be ignored for storage and analysis, thereby ensuring more accurate monitoring and analysis for providing proper monitoring and care.

[0059] According to a further aspect, a method of monitoring feet for detection of ulcer onset is provided. The method comprises sensing a temperature profile with a non-wearable device of a first foot, the temperature profile comprising contact temperature measurements from at least one of: sides of the foot, heel, ankles, tips of toes, top of the toes and the instep; sensing a temperature profile with the non-wearable device of a second foot, the temperature profile comprising contact temperature measurements from similar positions on the second foot as the contact temperature measurements of the first foot, and comparing the temperature profile of the first foot with the temperature profile of the second foot to determine any variations.

[0060] Such a method enables comprehensive comparison of temperature profiles between feet, including areas not typically measured by conventional devices, potentially improving sensitivity and specificity in detecting early signs of ulcer formation. Such early detection can lead to treatment and / or prevention of growth of the ulcer or other sore.

[0061] According to an embodiment, the method further comprises sending an alert when variations outside a range are found. Alerts (e.g., automatically sent) based on temperature profilecomparisons can prompt timely intervention, potentially preventing the progression of foot complications.

[0062] According to an embodiment, the step of comparing the temperature profile of the first foot with the temperature profile of the second foot to determine any variations comprises comparing the temperature sensed at a specific position of the first foot with the temperature sensed at the same or mirrored position on the second foot. Point-by-point comparison between feet can highlight localized temperature anomalies that might be missed by more generalized comparison methods, potentially improving early detection of foot complications.

[0063] According to an embodiment, the method comprises comparing sensed measurements to stored data regarding previous temperature measurements at particular positions, and sending an alert when the sensed measurements vary outside a range from the previous temperature measurements. Comparison of temperature measurements with previous measurements can detect gradual changes in foot health that might not be apparent from single-time comparisons between feet, potentially improving long-term monitoring effectiveness.

[0064] According to an embodiment, the method includes identifying erroneous measurements and not storing and / or using such erroneous measurement in the comparisons. This can ensure that erroneous measurements are not used, thereby reducing false alerts of a potential ulcer.Brief description of the drawings

[0065] The present invention will be discussed in more detail below, with reference to the attached drawings, in which:

[0066] Figure 1 A illustrates a top view of an assembly for monitoring foot temperature.

[0067] Fig. 1B illustrates a side cross-sectional view of the assembly of Fig. 1A.

[0068] Fig. 2A illustrates a cross-sectional view of a first embodiment of a device with a foot being inserted, and in a receiving position.

[0069] Fig. 2B illustrates the device of Fig. 2A in a sensing position.

[0070] Fig. 3A illustrates a cross-sectional view of a second embodiment of a device with a foot being inserted, and in a receiving position.

[0071] Fig. 3B depicts the device of Fig. 3A in a sensing position.

[0072] Fig. 4A illustrates a cross-sectional view of a third embodiment of a device with a foot being inserted, and in a receiving position.

[0073] Fig. 4B shows the device of Fig. 4A in a sensing position.

[0074] Fig. 5A illustrates a cross-sectional view of a fourth embodiment of a device with a foot being inserted, and in a receiving position.

[0075] Fig. 5B illustrates the device of Fig. 5A in a sensing position.

[0076] Fig. 6A shows a cross-sectional view of an embodiment of a base.

[0077] Fig. 6B depicts the base of Fig. 6A supporting a foot.

[0078] Fig. 6C illustrates a cross-sectional view of the base of Fig. 6A in another direction.

[0079] Fig. 7A shows a cross-sectional view of a further embodiment of a base.

[0080] Fig. 7B depicts the base of Fig. 7A with a foot supported.

[0081] Fig. 8A shows a cross-sectional view of a further embodiment of a base.

[0082] Fig. 8B shows the base of Fig. 8A with a foot supported.

[0083] Fig. 9A depicts a side view of an embodiment of a device for measuring foot temperature.

[0084] Fig. 9B illustrates a back view of the base of Fig. 9A supporting a foot and in a sensing position.

[0085] Fig. 10 shows a schematic view of a grid of sensors in a base.

[0086] Fig. 11 A depicts a cross-sectional view of an embodiment of an upper part interacting with toes.

[0087] Fig. 11 B illustrates a side view of Fig. 11 A along one toe.

[0088] Fig. 12A shows a cross-sectional view of a further embodiment of an upper part interacting with toes.

[0089] Fig. 12B depicts a side view of Fig. 12A along one toe.

[0090] Fig. 12C illustrates a top view of the upper part of Fig. 12A.

[0091] Fig. 13A illustrates a side view of a part of a base of a device with an ankle monitor.

[0092] Figs. 13B-13C show a back view of Fig. 13A, with the ankle monitor in open and sensing positions, respectively.

[0093] Fig. 14A illustrates a perspective view of an embodiment of an upper part from a top side.

[0094] Fig. 14B illustrates a perspective view of the upper part of Fig. 14A from an bottom side.

[0095] Fig. 14C illustrates a perspective view of the upper part of Fig. 14A from a front side.

[0096] Fig. 14D illustrates a cross-sectional view of the upper part of Fig. 14A.

[0097] Figs. 14E-G illustrate the foam curvature, with cross-sectional views shown in Figs. 14F and 14G.

[0098] Figs. 15A-15D illustrate the upper part of Figs. 14A-14D in use.

[0099] Fig. 16 shows a top view of a device accommodating one foot.

[0100] Figs. 17-18 depict top views of foldable assemblies comprising two devices.

[0101] Fig. 19 depicts a top view of a further embodiment of an assembly, where the upper part is smaller.

[0102] FIG. 20 illustrates a flowchart for a method of monitoring skin temperatures on one or more feet.

[0103] FIG. 21 illustrates a flowchart for a method 300 of monitoring foot temperature profiles.Detailed description

[0104] The present disclosure relates to skin temperature monitoring for the detection of foot ulcer onset and devices and methods for such monitoring. The device is configured to measure temperatures at multiple locations on the foot, including areas that are prone to inflammation and ulcer development which prior art devices did not typically monitor. These areas may include the sole, sides, instep, ankles, and / or toes of the foot.

[0105] The device comprises a base for receiving and supporting the sole of the foot. An upper part is positioned above the base and configured to at least partially surround an upper portion ofan inserted foot. This arrangement allows for comprehensive temperature monitoring of various foot surfaces.

[0106] A plurality of temperature sensors are arranged on at least one of the base and the upper part. These sensors are configured to measure temperature at multiple locations on the foot, including at least one location selected from: sides of the foot, tips of the toes, top of the toes, and the instep. By measuring temperatures at these diverse locations, the device can provide a more complete picture of potential inflammation or ulcer development than prior art devices.

[0107] The temperature sensors used in the device are contact temperature sensors. This means they directly contact the skin surface to obtain accurate temperature readings, allowing for precise and accurate measurements at specific points on the foot (e.g., as compared to infrared measurements). While we state that the sensors are in “direct contact” with the skin, this can include various sensor components and / or cover layers (e.g., a biocompatible layer such as Thermoplastic polyurethane (TPU), Polyethylene terephthalate (PET), silicone or another flexible material) between the skin and the sensors.

[0108] Past devices typically only sensed temperature on the sole of the foot. Thus, these devices were much simpler, but they missed many areas prone to ulcer development, such as the sides, instep, ankles, and toes of the foot. By providing comprehensive temperature monitoring capabilities, the devices and methods described herein help to enable early detection of temperature changes that may indicate inflammation or potential ulcer formation. This can be particularly beneficial for individuals at risk of developing foot complications, such as those with diabetes or peripheral neuropathy, peripheral artery disease and / or foot deformations.

[0109] An embodiment of an assembly 10 for monitoring foot temperature is shown in FIG. 1A and FIG. 1B. FIG. 1A illustrates a top view of the assembly 10, while FIG. 1B provides a side cross-sectional view.

[0110] The assembly 10 comprises a first device 12 and a second device 14 arranged side-by-side. The first device 12 and the second device 14 are configured to each receive one foot of a user. The assembly 10 includes a display 16, which in this embodiment is positioned between the first device 12 and the second device 14, thereby allowing for easy visibility to a user when their feet are placed in the assembly 10.

[0111] Each of the first device 12 and the second device 14 includes a base 18 that forms a platform for supporting the soles of feet, and provides the user guidance on proper placement of the foot. An upper part 20 is provided above each base 18, forming a receiving space for a foot. The upper part 20 has a shape configured to extend over the upper portion of the foot area, including the toes 108 and at least part of the instep 106. Such a shape can, for example, be curved around the front (e.g., toes) of the foot and / or sides of the front part of the foot.

[0112] The base 18 includes regions for placement of the feet, which are typically flexible to conform at least partially around sides of the feet 100. A platform 19 extends around and below first device 12 and second device 14 to frame and support the assembly 10. By extending the base 18 into the platform 19, the user may be able to more easily insert their feet, and the base 18 can curve up at least partially around the sides of the foot to allow for temperature measurements on the sidesof the foot near the sole. This can also result in a more compact assembly 10, and one which protects the sensitive parts of devices 12, 14 (e.g., base 18 and upper part 20).

[0113] The assembly 10 may be battery powered, with an external charger that can be decoupled, and / or could simply plug in for power. A battery powered configuration provides portability and convenience for users.

[0114] The assembly 10 may have a modular design to allow cleaning and / or refurbishment, for example, by cleaning and / or removing and replacing pads that have touched the skin. This could enhance the longevity and hygiene of the device.

[0115] The assembly 10 may be connected to the cloud through a wireless connection, in some embodiments, independent from home infrastructure such as cellular or Internet of Things (loT). This connectivity can allow the assembly 10 to send data to the cloud and / or receive firmware updates through the cloud. Other devices can connect through in-home Wi-Fi, Bluetooth or another method.

[0116] The base 18 may have a contour or other indicator (e.g., different colour and / or material) of the foot to promote proper and consistent foot placement. This feature can help guide the user in foot placement providing a clear indication of where and at which orientation the feet should be placed, thereby helping to ensure effective and repeatable measurements. Such a feature can also reduce the complexity needed for data analysis after measuring.

[0117] The assembly 10 may be capable of saving data for multiple days to enable monitoring, for example, when limited connectivity is available. Additionally, the assembly 10 may be able to analyze temperature data on-device, providing immediate feedback to users.

[0118] In some examples, the assembly 10 may use a reminder indicator or light from the display 16 and / or a grazing light (e.g., from below) to provide reminders to use when stored out of sight, for example, under a bed. This feature helps remind a user, to encourage regular use of the device, even when it is not immediately visible.

[0119] Thus, the device shown in FIGS. 1A-1B allows for easy and accurate temperature measurements of multiple locations on a user’s foot, including locations which prior art could not monitor. Various configurations of the base, upper part and other components will be described with respect to the following figures. While they are described individually, different components could be combined to form a device which is most suitable for the specific user.

[0120] FIG. 2A illustrates a cross-sectional view of a portion of a device for monitoring foot temperature, showing the interaction between a foot 100 and various components of the device. FIG. 2B illustrates a cross-sectional view of the device of FIG. 2A in a sensing position. The device can be part of an assembly (as in FIGS. 1A-1B), or could be stand-alone (see FIG. 13).

[0121] The device includes a base 18 that provides structural support and a receiving surface for a sole 102 of a foot 100. The base 18 may comprise flexible material and / or a flexible surface. In some examples, the base 18 may comprise a rigid substrate for the sole 102, either flat or curved along the mid-foot in addition to or in place of the flexible material / surface.

[0122] An upper part 20 extends upward from the base 18 and includes sensors 22 arranged to contact different regions of the foot 100, including the toes 108 and the instep 106. The upper part20 may comprise flexible material to conform to the contours of the foot 100, and typically wraps around the sides of the foot as well (though this is not shown in these cross-sectional views).

[0123] The base 18 is moveable to enable contact between the foot 100 and the upper part 20 for enabling sensing on at least one of: the sides 104 of the foot, tips 107 of the toes 108, top 109 of the toes 108 and the instep 106. In some examples, the base 18 is tiltable from a receiving position (FIG. 2A) to a sensing position (FIG. 2B), pivoting around a point at or below the base 18. The sensing position tilts the base 18 such that the toes 108 and at least part of the instep 106 is in contact with the upper part 20, as shown in FIG. 2B. Then the base can be easily tilted back to the receiving position of FIG. 2A for removal of the foot once the measurements are completed.

[0124] When the foot 100 is placed on the base 18, the base 18 may flex partially around at least one side 104 of the foot 100 to position at least one sensor 22 to sense a skin temperature on the side 104 of the foot 100. Possibilities to enable this are discussed and shown in more detail in relation to FIGS. 6A-9B. This flexibility allows the device to accommodate different foot shapes and sizes while maintaining proper sensor contact.

[0125] The sensors 22 are positioned to measure temperature at multiple locations through skin contact measurements, including at one or more of the sole 102, sides 104, instep 106, and toe 108 regions of the foot 100. The sensors 22 are arranged in a pattern along the base 18 and / or the upper part 20 to enable temperature measurements when the foot 100 is placed in the device and the base 18 is tilted into the sensing position of FIG. 2B.

[0126] In the example shown in FIGS. 2A-2B, the upper part 20 is non-moving. The arrangement of the moveable base 18 and upper part 20 work together to accommodate different foot sizes while ensuring proper sensor contact in a sensing position, allowing for comprehensive temperature monitoring of various foot surfaces, and enabling early detection of temperature changes that may indicate inflammation or potential ulcer formation. Making only the base 18 moveable can help to reduce the complexity with fewer moving parts, and therefore may also reduce the cost as well as maintenance and / or repair needs of the device.

[0127] FIGS. 3A and 3B illustrate a side cross-sectional views of a portion of a further embodiment of a device for monitoring foot skin temperature. Such a device could be stand-alone or part of an assembly.

[0128] The device includes an upper part 20 that is movably connected to the base 18 via one or more links 36. One or more links 36, 38 also enable controlled movement of the upper part 20 relative to the base 18. In this case, an arm 36 rotatably connects to each of base 18 and upper part 20 to move upper part 20 when base 18 is moved by the foot 100. Upper part 20 is also supported by upper part support 38, formed here by a base and arm rotatably connected to the upper part 20, which also help guide movement between the receiving and sensing positions. The one or more links 36, 38 are positioned to facilitate a specific range of motion between the upper part 20 and the base 18, to allow contact between the sensors 22 on the upper part 20 and the toes 108 and / or instep 106.

[0129] Sensors 22 are positioned on the upper part 20 and / or base 18 to contact the sides 104, instep 106 and / or toes 108 of the foot 100 when the device is in use and in the sensing position (FIG. 3B).

[0130] FIG. 3A shows the device configured to receive the foot 100, and in a receiving position to allow for the foot 100 to be inserted between the base 18 and the upper part 20. The base 18 can then be moved or tilted, by the foot 100, manually or automatically (e.g., through a motor), causing the upper part 20 to move into the sensing position (shown in FIG. 3B) with the movement of the base 18. In this embodiment, a forward end of the base 18 is tilted downward to move into the sensing position. This tilting movement moves upper part 20 down toward the foot 100 through link 36. This movement facilitates contact between the sensors 22 and various surfaces of the foot 100 contacted by the upper part 20 when the base 18 is moved or tilted. Thus, this configuration enables temperature measurements at multiple locations including one or more of the toes 108, sides 104 and instep 106 regions of the foot 100 when in the sensing position of FIG. 3B.

[0131] The configuration shows how the device, with the one or more links 36 allows the upper part 20 to move with the movement of the base 18, in a manner that facilitates contact between the sensors 22 and various surfaces of the foot 100. Such movement thus enables easy contact temperature measurements at multiple locations including the toes 108, sides 104 and / or instep 106 regions of the foot 100.

[0132] FIGS. 4A and 4B illustrate side cross-sectional views of a portion of a further embodiment of a device for monitoring foot skin temperature. The embodiment shown in FIGS. 4A and 4B operates similarly to the embodiment shown in FIGS. 3A and 3B. However, the embodiment of FIGS. 4A-4B supports the base 18 from a front of the base 18, and rotates around that support point at the front. In this embodiment, the link 36 extends between the base 18 and the upper part support 38, which is then connected to the upper part 20. FIG. 4A shows the device in a receiving position, and FIG. 4B shows the device in the sensing position.

[0133] The base 18 is tilted to the sensing position, either manually by the foot 100 and particularly the heel or back portion of the foot pressing downward on a pack part of the base 18, or automatically. In some automatic embodiments, this automatic movement could happen when a foot is detected in the device. The one or more links 36, 38 then cause the upper part 20 to move downward and come into contact with the toes 108 and / or instep 106 of the foot 100.

[0134] The one or more links 36, 38 are positioned to facilitate a specific range of motion between the upper part 20 and the base 18, to allow contact between the sensors 22 on the upper part 20 and the toes 108, sides 104 and / or instep 106 of the foot 10 in a sensing position. The upper part support 38 helps maintain proper alignment and stability of the upper part 20 during this movement, and helps to hold the device in the receiving position ready to receive a foot when not in use.

[0135] The configuration shows how the device, with the one or more links 36, 38 allows the upper part 20 to move with the movement of the base 18, in a manner that facilitates contact between the sensors 22 and various surfaces of the foot 100, thus enabling temperature measurements at multiple locations including one or more of the toes 108, sides 104 and instep 106 regions of thefoot 100, while maintaining stability through the base 18, the one or more links 36, and the upper part support 38.

[0136] While the one or more links 36, 38 are shown as rotatable arms, this is for example purposes only and in other embodiments they may comprise one or more of a spring, arm, band, pulley and / or gear. These components allow for controlled movement and positioning of the upper part 20 relative to the base 18, ensuring proper contact between the sensors 22 and the foot 100 surfaces while being gentle enough to not damage the foot during the process of contacting and / or movement.

[0137] FIGS. 5A and 5B illustrate side cross-sectional views of a portion of a further embodiment of a device for monitoring foot skin temperature. FIG. 5A shows the device in a receiving position, while FIG. 5B shows the device in a sensing position.

[0138] The device includes a base 18 configured to receive and support the sole 102 of the foot 100. An upper part 20 is positioned above the base 18, and is configured to at least partially surround an upper portion of an inserted foot 100.

[0139] In this embodiment, the base 18 is movable vertically from the receiving position shown in FIG. 5A to the sensing position shown in FIG. 5B. The vertical movement of the base 18 moves upper part 20 through link 36 to enable contact between the foot 100 and the upper part 20 for sensing on at least one of: the sides 104 of the foot, tips of the toes 108, top of the toes 108 and at least part of the instep 106.

[0140] The one or more links 36 connect between components of the device, here a support 37 and the upper part 20, wrapping around a protrusion from the base 18, to facilitate a specific range of motion between the upper part 20 and the base 18. In this example, the one or more links 36 comprise a cable or pulley system which pulls the upper part 20 downward when the base 18 is moved in a downward or vertical direction. This configuration moves the upper part 20 into an upper sensing position as shown in FIG. 5B, where the upper part 20 comes into contact with various surfaces of the foot 100, thus enabling temperature measurements at multiple locations including one or more of the toes 108, sides 104 and instep 106 regions of the foot 100.

[0141] This vertical movement configuration may be beneficial for accommodating users with limited ankle mobility. By moving the base 18 and upper part 20 vertically rather than through a tilting motion, users may find it easier to insert and remove their feet from the device (with just a horizontal movement into or out of the device), potentially improving comfort and ease of use.

[0142] Thus, FIGS. 2A-5B show and describe various embodiments of movement systems for enabling the device to go from a receiving position to a sensing position (and vice versa). While these specific examples are shown, other configurations and / or combinations could be implemented to enable foot insertion, contact sensing and then foot removal from the device.

[0143] The base 18 of the device may include various flexible configurations to accommodate different foot shapes and sizes while maintaining proper sensor contact. These configurations allow the base 18 to conform to the contours of the foot 100, particularly around the sides 104, heel 102 and / or sole 102, and possible embodiments are set out in FIGS. 6A-9B. The various configurationscould be combined with any of the configurations shown and described in FIGS. 1A-5B and 11A-17.

[0144] FIG. 6A illustrates a cross-sectional view of a portion of a base 18 of a device for measuring foot temperatures, and FIGS. 6B-6C show cross-sections of the base 18 supporting a foot 100. The base 18 includes a flexible surface 26 that extends across tops 25 of supports 24

[0145] Sensors 22 are positioned along the flexible surface 26. In some examples, the sensors 22 may be incorporated into the flexible surface 26, for example, through printing on the flexible surface 26. The flexible surface 26 may be made of Thermoplastic polyurethane (TPU), Polyethylene terephthalate (PET) or another biocompatible film with conducting traces directly printed (e.g., screen printed) on the film. Skin can touch the film on one surface, while sensors (e.g., thermistors, temperature sensor integrated circuit) can be attached on the opposite surface, with conductive adhesive (e.g., epoxy) making the connection between flexible film and rigid component sufficiently robust.

[0146] Alternatively a flexible PCB could be used, cut such that bending over two axes is possible (e.g., with radii >= 6 mm). The PCB, including copper pads and thermal vias, could be attached to one surface of a biocompatible film with skin touching the film from the opposite surface.

[0147] The supports 24 are arranged in a spaced configuration, and can extend around the edge of the base to allow the flexible surface 26 to receive a foot 100 and conform to foot contours. As shown, the supports 24 are generally flexible, but still stable enough to support a foot. The supports 24 and support tops 25 help maintain the flexible surface 26 in a generally horizontal position when not in use (FIG. 6A), while allowing controlled deformation when pressure is applied by the sole 102 of a foot 100 (FIGS. 6B-6C). In some examples, the flexible surface 26 extends substantially planar with a top 25 of the supports 24 when no foot 100 is on the base 18.

[0148] FIGS. 6B-6C illustrate views of FIG. 6A in use, with a foot 100 on the flexible surface 26. Supports 24 can extend around the entire perimeter of base, or in other embodiments just on two or three sides. When the foot 100 is placed on the flexible surface 26 of base 18, positioned between supports 24, the supports 24 flex inward to allow for the flexible surface 26 with sensors 22 to conform around the sole 102 and partially around the sides 104 of the foot 100 (including the front and back) as shown in FIGS. 6B-6C. The supports 24 provide structural support while allowing the flexible surface 26 to deform and make contact and therefore make temperature measurements on the sole 102 and sides 104 of the foot 100. FIG. 6C shows the flexible surface 26 flexing around the front (ends of the toes 108) and the back (heel) of the foot 100 for additional sensor measurements at those positions.

[0149] In some examples, the supports 24 are made of deformable material (e.g., foam) and / or comprise one or more bands or springs to guide the flexing of the flexible surface 26 partially around at least one side 104 of the foot 100. Such a configuration can allow for better conformity to different foot shapes and sizes.

[0150] FIG. 7A illustrates a cross-sectional view of a portion of a base 18 of a device for measuring foot temperature. Similar to FIG. 6A, the base 18 includes a flexible surface 26 that extends across the tops 25 of supports 24. However, in this embodiment, the supports 24 are substantially rigidand non-bending, though may rotate inward (e.g., from a bottom). Sensors 22 are positioned along the flexible surface 26.

[0151] FIG. 7B illustrates a view of FIG. 7A in use, with a foot 100 on the flexible surface 26. When the foot 100 is placed on the flexible surface 26, positioned between supports 24, the flexible surface 26 with sensors 22 flexes inward and downward to conform around the sole 102 and partially around the sides 104 of the foot 100, which could include the front and the back (though is not shown in the figures). The supports 24 provide rigid structural support while allowing the flexible surface 26 to deform and maintain contact with the foot 100 to enable the sensors 22 to make temperature measurements on the sole 102 and sides 104 of the foot 100. Providing rigid supports 24 can provide more substantial support of the foot while still allowing for flexing of the flexible surface 26, which can be especially useful for heavier users and / or possibly extend the working life of the base 18.

[0152] FIG. 8A illustrates a cross-sectional view of a portion of a further embodiment of a base 18 of a device for measuring foot temperature. The base 18 includes a flexible surface 26 that forms a channel 28 between supports 24, even when no foot is inserted. The channel can in some embodiments include flexible material.

[0153] In this embodiment, the supports 24 are substantially rigid and non-bending, and extend in an upside-down L-shape. Springs 30 extend between the supports 24 and flexible surface 26, holding the flexible surface 26 in a curved configuration forming the channel 28 between the supports 24. The supports 24 and springs 30 are arranged to provide structural support while allowing the flexible surface 26 to flex and further conform when in use to accommodate different foot shapes and sizes while maintaining sensor contact to make temperature measurements on the sole and sides 104 of the foot 100.

[0154] FIG. 8B illustrates a view of FIG. 8A in use, with a foot 100 on the flexible surface 26. When the foot 100 is placed on the flexible surface 26, positioned between supports 24, the flexible surface 26 with sensors 22 flexes inward and down to conform around the sole 102 and partially around the sides 104 of the foot 100. The use of a channel 28 and springs 30 can provide for more sensor 22 contact and measurements higher up the sides (including back and front) of the foot 100, thereby enabling greater inflammation detection.

[0155] In summary, the various flexible base configurations shown and described enable the device to adapt to different foot shapes and sizes while maintaining proper sensor contact for accurate temperature measurements. The ability to conform to the foot contours and flex around the sides (including front and back) allows for more comprehensive monitoring of temperature changes that may indicate inflammation or potential ulcer formation than past systems with substantially rigid bases and which did not conform to make side of foot measurements.

[0156] In some examples, the flexible surface 26 may be either a biocompatible film with conducting traces printed thereon, ora flexible printed circuit board (e.g., polyimide / Kapton based), which is cut to allow bending over two axes (e.g., with radii greater than or equal to 6 mm). Such configurations can provide flexibility while maintaining the integrity of the electrical connections. The sensors 22 may, in some embodiments, have large heat conducting pads to ensure the majority ofthe flexible surface 26 gets sampled even when a contact point (e.g., a toe) only partially touches the heat conducting surface. Such a design can allow for more comprehensive temperature measurements across the foot surface to ensure that the majority of the flexible surface gets sampled.

[0157] FIGS. 9A and 9B illustrate a further embodiment of a device for measuring foot temperature, with FIG. 9A showing a side view of the device, while FIG. 9B depicts a back view of the device in a sensing position with a foot 100 inserted.

[0158] The device includes an upper part 20 connected to a base 18. The base 18 comprises a platform 32 that is moveable or tiltable from a receiving position as shown in FIG. 9A to a sensing position as shown in FIG. 9B. In the sensing position, the heel of the foot 100 pushes a back portion of the platform 32 downward.

[0159] A flexible surface 26 with sensors 22 is positioned above or on the platform 32. The flexible surface 26 is connected to strings 34 that enable the flexible surface 26 to conform around portions of the foot 100 when the foot 100 is placed on the platform 32 and the heel portion is pushed downward as shown in FIG. 9B.

[0160] When the platform 32 moves or tilts downward into the sensing position, the strings 34 draw the flexible surface 26 at least partially around at least one side 104 of the foot 100. This movement brings the flexible surface 26 into contact with the sides 104 (including back and / or front) of the foot 100. The flexible surface 26 with sensors 22 is then positioned to contact the foot 100 and take measurements when the flexible surface 26 is drawn against the foot 100 by the strings 34. This configuration allows for comprehensive temperature monitoring of various foot surfaces, including the sides 104 of the foot 100, which may be prone to inflammation or ulcer development.

[0161] The use of strings 34 to draw the flexible surface 26 around the foot 100 as the platform 32 moves provides a mechanism for ensuring good sensor contact with multiple surfaces of the foot 100. This design allows for adaptability to different foot shapes and sizes while maintaining proper positioning of the sensors 22 for accurate temperature measurements when the device is in a sensing position. The flexible surface 26 can be similar to that shown and described with respect to FIGS. 6A-8B.

[0162] FIG. 10 illustrates a schematic view of a grid of sensors 22, for example in a base 18 and / or flexible surface 26. The base 18 can have a curved profile generally correlating to the shape of a foot, and can be of different sizes depending on the intended user.

[0163] The sensors 22 are arranged in a triangular grid pattern and positioned to enable temperature measurements at various locations when a foot 100 is placed in the device. The arrangement of the sensors 22 follows a triangular grid to enable appropriate amounts of sensors 22 for each various portion of the foot 100. As mentioned (though not shown) a conducting pad could be associated with each sensor.

[0164] The plurality of sensors 22 have a different sensor density depending on the part of the foot 100 with which the sensor 22 will come into contact. Specifically, the sensors 22 are placed more densely near the toes 108, while less densely on the rest of the sole 102 and the heel. This configuration allows for more precise temperature measurements in areas that are more prone toulcer development and / or need more measurements to ensure any potential issues are spotted quickly, such as at the toes 108 due to the non-contiguous anatomy (e.g., air gaps in between).

[0165] In the region near the toes 108, the sensors 22 are generally spaced at or less than half a toe width, with approximately 6 mm maximum distance between sensors 22. This spacing can help to ensure that even small temperature variations in the toe area can be detected, as well as help to ensure detection when toes are oddly shaped or positioned, meaning they would not necessarily contact all sensors in a grid (e.g., hammertoes).

[0166] The triangular grid formation ofthe sensors 22 provides efficient coverage of the foot 100 surface while minimizing the total number of sensors 22 required. This arrangement allows for comprehensive temperature monitoring ofthe foot 100 while optimizing the use of sensors 22.

[0167] Such a sensor 22 grid configuration in the base 18 works in conjunction with the sensors 22 in the upper part 20 to provide a complete temperature profile of the foot 100, including one or more of the sole 102, sides 104, instep 106, and toes 108. Past monitoring pads typically had a non-varying sensor (density) pattern, thereby undersampling in some areas or using far more sensors than needed in others. The configuration shown and describe here allows for optimizing the use of sensors by varying sensor density according to the part of the foot which the sensors will contact. Thus, the comprehensive coverage enables the device to detect temperature variations that may indicate inflammation or potential ulcer formation in various areas of the foot 100 while only using the amount of sensors necessary, thereby keeping the device less complex and more economical to produce. While not shown, the sensor configuration in the upper part could have a similar triangular grid and density pattern as that shown for the base in FIG. 10.

[0168] FIGS. 11A and 11B illustrate cross-sectional views of an embodiment of an upper part 20 of a device, showing an arrangement of the upper part 20 interacting with toes 108.

[0169] The upper part 20 comprises flexible material 40 that extends across multiple toes 108, and helps to allow for conforming around and between toes 108. A biocompatible layer 42 is positioned below the flexible material 40 for contacting the toes 108. The biocompatible layer 42 comprises sensors 22 for providing temperature measurements, which can be connected and / or formed as part ofthe biocompatible layer 42. Rigid material 44 is positioned above the flexible material 40 to provide structural support.

[0170] The arrangement shown allows the flexible material 40 and biocompatible layer 42 to conform to the shape of the toes 108, extending on the tops 109 and at least partially around the tips 107 and sides of toes to make and maintain contact for temperature sensing. FIG. 11A depicts five toes 108 positioned beneath the layered structure, demonstrating how the components interact with multiple toes simultaneously, even when toes 108 don't align with each other. FIG. 11 B shows a side view along one toe 108, illustrating how the flexible material 40 and biocompatible layer 42 with sensors 22 conform to the toe upper surface 109, even when the toe 108 has an unusual shape such as a hammertoe.

[0171] FIGS. 12A, 12B, and 12C illustrate views of another embodiment of an upper part 20 of a device, showing an arrangement ofthe upper part 20 interacting with toes 108. In this embodiment, the upper part 20 comprises a plurality of adjacent fingers 50 extending in an insertion direction.Each finger 50 of the plurality of fingers 50 is connected to and extends from an upper part base 52 at a distal end of the upper part 20. The fingers 50 can be dimensioned and spaced such that a certain number of fingers 50 contact each toe 108, for example, at least 2 fingers per toe. Each finger 50 is about 3-11 mm wide, preferably 4-6 mm wide. The plurality of fingers 50 are 5-40 fingers, preferably 10-30 fingers, more preferably 10-20 fingers, most preferably 12-18 fingers.

[0172] Each finger 50 comprises flexible material 40, and a biocompatible layer 42 with sensors 22 is positioned below and / or around the flexible material 40 for contacting the toes 108 and providing temperature measurements. Rigid material 44 is positioned above the flexible material 40 to provide structural support, and the rigid material 44 typically connects to or is formed integral with upper part base 52.

[0173] Each finger 50 is able to at least partially adapt to contact the respective side 104, toe 108 and / or the instep 106 at the respective finger position. FIG. 12B shows a side view along one toe 108, illustrating how a finger 50 with flexible material 40 and biocompatible layer 42 with sensors 22 conform to the toe surface, even when the toe 108 has an unusual shape.

[0174] FIG. 12C illustrates a top view of the upper part 20 of FIG. 12A. The view shows multiple parallel finger structures arranged in a row configuration and extending from the upper part base 52. Each finger 50 extends forward from the upper part base 52 toward the foot 100, and in the direction toward where the toes 108 would be positioned. The fingers 50 are spaced very close together, with minimal gaps between them to allow independent movement and deformation while ensuring most foot and toe surfaces can be measured.

[0175] Such arrangements, with a plurality of separate fingers 50 and / or flexible material with a biocompatible layer with sensors allows for flexibility in accommodating different sizes, positioning and shapes of toes 108 in the device while still ensuring there are many contact points for temperature measurements. The arrangement of parallel fingers 50 provides flexibility for accommodating variations in toe positioning and anatomy while maintaining consistent sensor contact with the toe surfaces and allowing for sensing further on the sides of or between toes 108. The embodiments of FIGS. 11A-12C can be used with any of the embodiments of bases 18, movement systems and other configurations described with respect to FIGS. 1A-10 and 13A-17.

[0176] FIGS. 13A-13C illustrate a view of a device with an ankle monitor 60 comprising first and second cushions 62, 64 connected to base 18 through supports 66 and cables 68. FIG. 13A shows a side view, with FIG. 13B showing a back view when in an open or receiving position. As best seen in FIG. 13B, supports 66 are angled outward, held in the open position by cables 68, to hold cushions 62, 64 far enough apart for a foot 100 to be inserted between.

[0177] Once foot 100 is inserted, base can be moved downward (for example, similar to the manner shown and described with respect to any of FIGS. 2A-5B), thereby moving cushions 62, 64 into contact with the ankles of the foot 100 through the cable 68 and support 66 connections. Each of cushions 62, 64 would have one or more sensors for taking temperature measurements at and / or around the ankles. Such ankle monitors 60 can be used in combination with any of the devices described herein and in some embodiment could be extended all the way down the heel and / or only cover the heel.

[0178] Fig. 14A illustrates a perspective view of an embodiment of an upper part 20 from a top side, Fig. 14B illustrates a perspective view of the upper part 20 from a bottom side, Fig. 14C illustrates the upper part 20 from a front side, and Fig. 14D illustrates a cross-sectional view of the upper part of Fig. 14A.

[0179] Upper part 20 shown in Figs. 14A-14D comprises a frame 70, upper layer 44, foam layer 40 and biocompatible layer 42. Frame 70 connects to upper layer 44 and / or foam layer 40

[0180] Frame 70 includes main body 72 with first and second arms 74 connected to and extending from main body 72. In some embodiments, arms 74 could be integrally formed with main body 70. Main body 70 is typically rigid, for example, formed of a rigid metallic, plastic or composite material, with arms 74 being held in place in the vertical direction, but flexible and able to bend or twist inward toward each other, particularly toward the distal ends (not connected to the main body 72). This flexibility can be through the materials used to form arms 74 (e.g., Polyethylene or another flexible plastic), and / or through the thickness of the material used to form arms 74. Frame 70 typically connects to a base 18 (see Fig. 15A) through a rotatable connection to the main body 72. Such a connection can be extending from the front side, as seen in Figs. 14A and 14C, or in other embodiments could be connected on a back side of the upper part 20. The connection can be through rod 75 extending along rotation axis A, allowing for front and back rotations perpendicular to the long axis of the foot when in use. In other embodiments, the connection can be directly through the arms 74.

[0181] Foam 40 has a generally symmetrical shape along the long axis of the upper part 20 (and foot) as can be seen in Fig. 14G, which can enable taking sensor measurements on the right and left feet. At the toe side or front end 41 (shown in cross-section in Fig. 14E), there is curvature downward to ensure good contact with the toes and end of the foot. The thickness at this point can be about the same from one side to the other, with ti being around 30-40mm, for example, 35 mm. Foam 40 has central curvature extending its longitudinal length towards the back forming a hill 43 extending on each lateral side. The curvature between the hills 43 is such that the tops of the hills touch the side of the foot at the metatarsal heads when in use (see Figs. 15D-15E), which can be an important measurement location, particularly for large feet. The curvature also helps to keep the product compact, taking up less space than a non-curved part. Dimensions of the foam 40 can vary from front to back, for example, having a thickness similar or the same as ti at the center point of the curvature in the back (e.g., 30-40 or 35 mm) with a larger thickness on the hills, for example, t2 being about 35 mm -50 mm, or 40 mm. This can help to accommodate different size and shaped feet through compression of foam 40 and flexing of the arms 74 to wrap foam 40 (and biocompatible layer 44) around the foot 100. In other embodiments, foam could be much thicker, for example, up to 135 mm, maintaining curvature and a difference between ti and t2.

[0182] Foam 40 can be supported on a top side by upper layer 42, extending between arms 74, with upper layer 42 forming the connections to arms 74 in addition to or in alternative to foam 40 connecting to arms 74. Upper layer 42 has little to no ability to stretch during use, ensuring that movement of the frame and arms 74 translates to movement of the foam 40 and biocompatible layer 44 around the foot. Examples of suitable materials (e.g., which bend but resist in-planestretching) for upper layer are polymer foams and elastomeric sheets (e.g., Polyurethane, Ethylenevinyl acetate, Polyvinyl chloride, Neoprene); woven polymer sheets (e.g., Polyethylene terephthalate or Nylon mesh); and thermoplastic thin sheets (e.g., Polyethylene , Polypropylene, Thermoplastic Polyurethane). In some embodiments, foam 40 itself could extend between arms 74, connecting directly and making for a more closed structure.

[0183] Foam 40 is surrounded by biocompatible layer 44, which stretches or is formed around foam 40 on all but its top side (which is covered by upper layer 42). Biocompatible layer 44 includes sensors for taking measurements on the foot, and sensor electronics can be placed between the biocompatible layer 44 and the foam 40. The biocompatible layer 44 can be a thin layer, for example, 10 urn - 100 urn thick of Thermoplastic Polyurethane (“TPU”) to allow for movement and flexing with the foam 40 around the foot 100.

[0184] Figs. 15A-15D illustrate the upper part of Figs. 14A-14D in use with a base. While a general base is shown, upper part 20 of Figs. 14A-15E could be used with any of the previously described bases 18. As seen in Fig. 15A, frame 70 can connect to base through rod 75 and pillars 76. Frame 70 could move up and down and rotate with respect to pillars 76 and base 18. In some embodiments, frame 70 would only rotate, and base would provide any vertical and / or tilting movements toward upper part 20 to put feet into a sensing position. The vertical and / or tilting movements (by upper part 20 and / or base 18) could be facilitated by a motor, or could be manually controlled. While such variations are possible, the description of Figs. 15A-15E will focus on an embodiment where frame 70 moves vertically and rotationally into the sensing position.

[0185] Figs. 15A-15C show views of a foot 100 being positioned with the device in a receiving position. Upper part 20 is an a receiving position, with frame 70 at an upper position. Once foot 100 is placed on base 18, frame 70 is lowered into the sensing position shown in Figs. 15D-15E. This can be manual or motorized movement, and could be automatic (e.g., with sensors sensing when the foot 100 is in place and then when the upper part 20 is in the proper position) and / or guided by the user. Movement can also involve rotating around rod 75, for example, rotating front side 41 downward.

[0186] As frame 70 moves downward, arms 74 move inward and flex or twist around the sides of foot 100, as shown in Figs. 15D (showing inward movement of distal ends of arms 74) and Fig. 15E (showing twisting and flexing movement of arms 74). Such movement and flexing is facilitated by the flexibility of arms 74, the inability or reduced ability of upper layer 42 to stretch and the flexibility of foam 40 and biocompatible layer 44. Thus, biocompatible layer 44 (with sensors) wraps around the top, sides and toes of foot 100, with hills 43 touching the sides of foot 100 at the metatarsal heads, helping to position sensors to facilitate taking measurements on top and side positions of the foot 100. Frame 70 can also be rotated around axis A to accommodate measurements at the toes as well as to accommodate variations in the instep angle of the foot 100.

[0187] Such a structure, with the frame 70 with flexible arms 74, shaped foam 40, upper layer 44 and biocompatible layer 42 facilitates easy and effective measurements at upper, side and end positions of the foot 100, areas which prior art sensors could not reach or could not easily facilitate measurements of. Such flexibility can allow for effectively and reliably sensing feet with a widthfrom 70 to 120 mm at the metatarsal joints, ensuring effective sensing of a wide variation of foot sizes and shapes, including hallux valgus and hammertoes. The thickness and curvature of foam 40 ensures that height differences in feet can be accommodated and compensated for by bending and compression while avoiding tenting or less optimal bending that could reduce sensor contact. Thus, the frame 70 with flexible arms 74, shaped foam 40, upper layer 44 and biocompatible layer 42 allow for effective sensing and measurements at the tips of the toes, tops of the toes, forefoot and sides of the foot from the metatarsal heads until the tips of the toes for more than 95% of all foot shapes and sizes. The flexible arms 74 and non-stretchable upper layer 44 apply pressure to ensure that sensors contact the skin even in hard to reach places of the foot 100, as the force direction changes based on the particular foot shape due to the flexibility of arms 74 and nonstretchability of upper layer 44.

[0188] FIG. 16 illustrates a top view of a portion of a device which accommodates one foot at a time. The device includes a base 18 and an upper part 20, which could be any combination of the bases 18 or upper parts 20 previously described.

[0189] Platform 19 provides a stable frame for the sensing and / or moveable parts of the device 12. In some embodiments, platform 19 could include a display. The base 18 is arranged on the platform 19 to receive and support a sole 102 of a foot 100. The upper part 20 is arranged to extend at least partially around a foot 100 inserted onto the base 18 in one of the manners previously described, and the device is moved into a sensing position. The base 18 may include a flexible surface 26 with sensors 22, as described in previous embodiments. The upper part 20 may be connected to the base 18, and moveable with respect to the base. Device 12 incorporates these components in an arrangement that allows for both support and flexibility in a compact package.

[0190] A user can make measurements of one foot first, and then subsequently make temperature measurements of the other foot. By accommodating one foot 100 at a time, the device can be more compact, allowing for easier travel and / or storage.

[0191] This single foot configuration provides benefits in terms of portability and ease of use. The compact size makes the device more convenient for users to transport, which may be particularly advantageous for individuals who need to monitor their foot temperatures while traveling. The simplified design, focusing on one foot at a time, may also make the device easier to use for some individuals, particularly those who may have difficulty positioning both feet simultaneously and / or moving or storing a larger device.

[0192] FIG. 17 illustrates a top view of an assembly 10 comprising a first device 12 and a second device 14. The first device 12 and second device 14 are arranged side by side and separated by a fold line F extending between the two. Each device includes a base 18 and an upper part 20. The fold line F indicates where the assembly 10 can be folded between the first device 12 and second device 14, folding one onto the other.

[0193] The vertical fold line F allows the first device 12 and second device 14 to be folded together, potentially reducing the footprint of the assembly 10 by half when folded. This design may be particularly useful for users who need to pack the device in a suitcase or bag fortravel. This folding capability can also help to protect the assembly 10 when not in use.

[0194] FIG. 18 illustrates a top view of an assembly 10, which also includes a first device 12 and a second device 14 arranged side by side. In this embodiment, the fold line F extends across the assembly horizontally, allowing for folding in the other direction of the assembly shown in FIG. 15. The fold line F extends across both bases 18, allowing upper parts 20 to be folded over bases 18. As bases 18 are sometimes recessed, this can provide for more compact folding of the assembly.

[0195] The horizontal folding configuration illustrated in FIG. 18 offers a different approach to compacting the assembly 10 than that of FIG. 17. By folding the upper parts 20 over the bases 18, the overall device can be made thinner, which may be preferable in certain storage situations. The recessed nature of the bases 18 allows for a more compact fold, potentially reducing the overall thickness of the folded assembly 10, allowing for easier transport and / or storage.

[0196] In some embodiments, the fold line F shown in FIGS. 17-18 could be a full separation line in addition to or in place of being a fold line.

[0197] Overall, the foldable or separable configurations shown in FIG. 17 and FIG. 18 provide benefits in terms of portability and storage. The ability to fold or separate the assembly 10 makes the device more compact when not in use, which can be particularly advantageous for users who need to transport the device or have limited storage space. The folding or separation mechanism can also serve as a protective feature, shielding the sensitive components of the device when folded. While shown with assemblies, folding and / or separation could be used with the single foot device shown and described with respect to FIG. 16.

[0198] FIG. 19 illustrates atop view of a portion of an assembly according to a further embodiment. The device is similar to the assembly of FIGS. 1 A-1 B and works similarly, but has a smaller upper part 20', which covers less of the inset 106 of the foot 100. Such an embodiment can be useful in monitoring users which have more limited mobility as it takes less movement for placing feet into or moving feet out of the device while still enabling sensor measurements at a number of foot regions.

[0199] FIG. 20 illustrates a flowchart for a method of monitoring skin temperatures on one or more feet. The process begins at step 200, where a device with a base, upper part, and sensors is provided. This could be any of the devices (or a combination) of those previously discussed.

[0200] The flowchart then progresses to step 202, where feet are positioned on the base of the device (or only a single foot is positioned if the device cannot accommodate two feet at the same time). In step 204, the upper part is brought into contact with upper foot portions, for example, through any of the movement systems previously discussed. During these steps (and further steps), the user can in some embodiments be given visual and / or audible cues to help guide foot placement and / or inform the user of progress of the measurements (e.g., be giving a running countdown for how long to keep the feet in the device for sensing).

[0201] The process continues to step 206, where temperature is measured at multiple foot locations, including at least one of sides 104 of the foot, ankles, tips of the toes 108, top of the toes 108 and the instep 106. This is through the sensors in the base and / or upper part of the device.

[0202] Step 208 involves storing foot measurements in memory, which may be at the device or remotely. The flowchart then moves to step 210, where first and second foot measurements are compared and / or analysed, which can be done directly on the device or can be done in step 212,where temperature data may be sent for storage and / or analysis to another location in step 214. Sometimes data can be saved for multiple days (e.g., when connectivity is limited), and only thereafter (e.g., when connectivity is re-established) is data sent for monitoring and analysis. Other embodiments can vary steps 212 and 214, first sending for storage / analysis before the comparison of the measurements.

[0203] After data transfer to the cloud and / or analysis in the cloud in step 214, measurement results can be shared with the user and / or care provider of the user in a number of ways. This could be through transferring data back to the device, sending a message (e.g., a SMS) to the user / care provider, via an app on the phone, via a web portal or by sending data to an electronic health record - which may or may not be accessible to the patient. Alternatively, the user or a care provider could be contacted by phone either by the healthcare professional or the monitoring company. Data could also be shared with healthcare professionals in a similar manner.

[0204] . In some cases, the method 200 could start with an audible or visual cue that a measurement is needed. This could be initiated through therapy adherence program, which could be integrated into the device and cloud environment that is adjustable by the healthcare provider and / or the user or care provider. Some embodiments could also give an audible or visual cue that measurements are done and the feet can be removed.

[0205] The flowchart depicts a sequential process to measure, store and / or analyse data regarding temperature measurements on multiple places on feet, thereby enabling detection of anomalies and possible early detection and identification of developing ulcers while giving users a comfortable experience in which they feel confidence in the device and process.

[0206] FIG. 21 illustrates a flowchart for a method 300 of monitoring foot temperature profiles. The method 300 begins at step 302, where a temperature profile of a first foot is sensed. The method 300 then proceeds to step 304, where a temperature profile of a second foot is sensed. These may be sensed one after another or simultaneously depending on the device or assembly used.

[0207] Following the temperature sensing steps, the method 300 moves to step 306, where the temperature profiles of both feet are compared. The method 300 then proceeds to a decision step 308, which determines if variations outside a range are found. Such a range may be a static range, for example, set in advance or set according to a measurement taken when the foot was fully healthy; or a dynamic range, for example, which changes dynamically depending on the most recent measurements (e.g., within 10% of the most recent measurement at that location).

[0208] In some embodiments, temperature data analysis can be normalized with a baseline correction for temperature differences due to other diseases, e.g. peripheral artery disease. This baseline can be recorded at a moment when no signs of ulcer onset are present. It can also be updated overtime by filtering out slow changes in spatial temperature profiles.

[0209] The method 300 then proceeds to step 312, where the temperature measurements can be compared to previous temperature measurements, for example, measurements taken the day(s) before. This leads to a decision step 314, which determines if there are variations outside the range found from step 308 or variations from previous measurements (e.g., outside an acceptable range) found in comparison step 312.

[0210] If the answer to either is yes, the method 300 proceeds to step 316, where an alert is sent for variations from previous measurements. If no variations from previous measurements or between feet are found (No branch) or only variations within an acceptable range are found, the method 300 bypasses step 316. Alerts may be audible, visual, tactile or any combination and may be directly on the device or assembly (e.g., through the display) or through another method (e.g., to the user or health care provider through a message or application).

[0211] The method 300 concludes at step 318, marked as "End". The flowchart shows a sequential process that involves measuring, comparing, and alerting based on temperature variations between feet and / or over time, thereby allowing for early detection and alerting to possible ulcer development.

[0212] In summary, the devices, assemblies and methods shown and described here help a user to easily and effectively monitor skin temperatures on multiple locations on the foot, including areas that are prone to inflammation and ulcer development. These areas may include the sole, sides, instep, ankles, and toes of the foot, at least some of which were difficult or impossible to monitor with prior art devices, particularly the non-wearable prior art devices. This is done through a device comprising a base for receiving and supporting the sole of the foot, and an upper part which is positioned above the base and configured to at least partially surround an upper portion of an inserted foot. These various configurations allow for the device to go from a receiving position where a foot can be easily inserted to a sensing position where sensors on the base and / or upper part come into contact with various parts of the foot. By measuring temperatures at these diverse locations, the device can provide a more complete picture of potential inflammation or ulcer development, particularly than past devices which could typically only take measurements on a sole of a foot thereby missing many areas prone to ulcer development.

[0213] Additionally, the various configurations to ensure that sensors make good contact with multiple locations on the foot enable faster measurements, thereby promoting more accurate measurements and better compliance with monitoring schedules by the user. By providing comprehensive temperature monitoring capabilities, the device enables early detection of temperature changes that may indicate inflammation or potential ulcer formation. This can be particularly beneficial for individuals at risk of developing foot complications, such as those with diabetes or peripheral neuropathy.

[0214] While the invention has been described herein by reference to certain embodiments, it is to be understood that modifications in addition to those described herein may be made to the structures and techniques described herein without departing from the spirit and scope of the invention. Accordingly, although specific embodiments have been described, they are examples only and are not limiting upon the scope of the invention.

Claims

Claims1. A non-wearable device (12, 14) for monitoring skin temperatures on a foot (100) comprising a sole (102), sides (104), an instep (106), ankles (107) and toes (108), the device comprising: a base (18) for receiving and supporting the sole of the foot;an upper part (20) positioned above the base (18), and configured to at least partially surround an upper part of an inserted foot; anda plurality of contact temperature sensors (22) arranged on at least one of the base (18) and the upper part (20), the plurality of sensors (22) configured to measure temperature at a plurality of locations on the foot (100), including at least one location selected from: sides (104) of the foot, tips of the toes (108), top of the toes (108) and the instep (106).

2. The device of claim 1 , wherein the base (18) comprises flexible material and / or a flexible surface), preferably further comprising heat conducting pads.

3. The device of claim 2, wherein the base (18) flexes partially around at least one side of the foot (100) when the sole (102) is on the base (18) to position at least one sensor (22) to sense a skin temperature on the side (104) of the foot.

4. The device of claim 3, wherein the base (18) comprises supports and a flexible surface (26) comprising one or more of the plurality of sensors (22).

5. The device of claim 4, wherein the supports (24) are deformable and / or comprise one or more bands or springs to guide the flexing of the flexible surface partially around at least one side of the foot.

6. The device of any of claims 4-5, wherein the flexible surface (26) extends substantially planar with a top of the supports (24) when no foot is on the base(18).

7. The device of any of claims 4-5, wherein the flexible surface (26) forms a receiving channel (28) below a top (25) of the supports when no foot is on the base (18).

8. The device of any of claims 3-4, wherein the base (18) comprises a moveable platform (32) and the flexible material (26) is drawn at least partially around at least one side of the foot (100) as the platform (32) moves, preferably wherein strings (34) draw the flexible material (26) comprising one or more sensors at least partially around at least one side of the foot as the platform (32) moves or tilts downward.

9. The device of any of the preceding claims, wherein the base (18) is moveable to enable contact between the foot (100) and the upper part (20) for enabling sensing on at least one of: thesides (104) of the foot, one or more ankles (107), tips of the toes (108), top of the toes (108) and the instep (106).

10. The device of claim 9, wherein the base (18) is tiltable from a receiving position to a sensing position.

11. The device of claim 10, wherein the sensing position tilts the base (18) such that the toes (108) and at least part of the instep (106) is in contact with the upper part (20).

12. The device of any of claims 10-11 , wherein the upper part (20) is non-moving.

13. The device of any of claims 10-11 , wherein upper part (20) is moved into an upper sensing position with the movement or tilting of the base (18).

14. The device of claim 13, wherein the upper part (20) is moved to the upper sensing position through one or more linkages (36) as the base (18) tilts from the receiving position to the sensing position.

15. The device of claim 14, wherein the base (18) moves vertically into the sensing position.

16. The device of claim 15, wherein the vertical movement of the base (18), moves the upper part (20) into an upper sensing position wherein the upper part (20) is in contact with at least one of: the sides (104) of the foot, tips of the toes (108), top of the toes (108), one or more ankles and at least part of the instep (106).

17. The device of claim 16, wherein the base (18) and the upper part (20) are connected by one or more links (36) such that the upper part (20) is moved toward the base (18) when the base (18) is moved into the sensing position, preferably wherein the one or more links (36) comprise one or more of a spring, arm, band, pulley or gear.

18. The device of any of the preceding claims, wherein the upper part (20) comprises flexible material (40).

19. The device of any of the preceding claims, wherein the upper part comprises a plurality of adjacent fingers (50) extending in an insertion direction (I), preferably wherein each finger (50) is able to at least partially adapt to contact the respective side, toe and / or the instep at the respective finger position.

20. The device of claim 19, wherein each finger (50) is about 3-11 mm wide, preferably 4-6 mm wide.

21. The device of any of claims 19-20, wherein each finger (50) the plurality of fingers is connected to and extends from a upper part base at an entrance side of the device.

22. The device of any of claims 19-21 , wherein the plurality of fingers are 5-40 fingers, preferably 10-30 fingers, more preferably 10-20 fingers, most preferably 12-18 fingers.

23. The device of any of the preceding claims, and further comprising an ankle monitor (60) configured to contact and take temperature measurements of one or more of the ankles in a sensing position.

24. The device of claim 23, wherein the ankle monitor (60) comprises first and second cushions (62, 64) comprising sensors, wherein the first and second cushions (62, 64) are moveable from a receiving position to a sensing position in which the first and second cushions contact the ankles, preferably wherein the first and second cushions (62, 64) are moved into the sensing position when the base (18) moves from a receiving position to a sensing position.

25. The device of any of the preceding claims, wherein the plurality of sensor (22) are in a triangular grid formation.

26. The device of any of the preceding claims, wherein the plurality of sensors (22) have a different sensor density depending on the part of the foot with which the sensor will come into contact.

27. The device of any of the preceding claims, wherein the upper part (20) comprises a frame (70), foam (40) and a biocompatible layer (42), preferably wherein the biocompatible layer (42) comprises at least one of the plurality of sensors (22).

28. The device of claim 27, wherein the upper part (20) further comprises an upper layer (44), preferably wherein the upper layer is rigid and / or non-stretchable.

29. The device of any of claims 27-28, wherein the frame (70) comprises a main body (72), and first and second arms (74) connecting the main body (72) to the foam (40) and / or upper layer (44), preferably wherein the first and second arms (74) connect on first and second sides of the foam (40) and / or upper layer (44).

30. The device of claim 29, wherein the first and second arms (74) connect to the foam (40) and / or the upper layer (44), and wherein the first and second arms (74) are able to flex such that the foam (40) and biocompatible layer (42) are able to bend around the foot.

31. The device of any of claims 27-30, wherein the frame is moveable and / or rotatable with respect to the base (18).

32. The device of any of the preceding claims, wherein each of the plurality of sensors (22) is a contact temperature sensor.

33. An assembly (10) comprising a first device (12) according to any of the preceding claims, and a second device (14) according to any of the preceding claims, wherein the first device (12) and the second device (14) are located adjacent to each other to each receive one foot (100) of a user.

34. The assembly of claim 33, wherein the assembly is foldable.

35. The assembly of any of claims 33-34, and further comprising a display (16), preferably wherein the display (16) is located between the first device (12) and the second device (14).

36. A method of monitoring skin temperatures on a foot, the method comprising:providing the device of any of claims 1-35;positioning a first foot (100) on the base (18) of the device (10);bringing the upper part (20) into contact with upper portions of the first foot (100); measuring temperature at the plurality of locations on the first foot (100) using the plurality of temperature sensors (22); andstoring the plurality of first foot measurements in a memory.

37. The method of claim 36, and further comprising:positioning a second foot (100) on the base (18) of the device (10);bringing the upper part (20) into contact with upper portions of the second foot (100); measuring temperature at the plurality of locations on the second foot (100) using the plurality of temperature sensors (22);storing the plurality of second foot measurements in a memory; andcomparing the first foot measurements with the second foot measurements to determine if there is variation.

38. The method of claim 37, and further comprising sending an alert if the variation is outside a range.

39. The method of claim 38, wherein the range is preset or determined dynamically based on variations in measurements taken.

40. The method of any of claims 36-39, wherein the steps of taking first foot measurements and second foot measurements are done simultaneously with the assembly of any of claims 33-35.

41. The method of any of claims 36-40, and further comprising providing visual and / or audible cues by the device to guide the user during monitoring and / or to remind the user to monitor.

42. The method of any of claims 36-41 , and further comprising sending temperature data for storage and / or analysis via a wired or wireless connection.

43. The method of any of claims 36-42, and further comprising error detection.

44. A method of monitoring feet for detection of ulcer onset, the method comprising:sensing a temperature profile with a non-wearable device of a first foot, the temperature profile comprising contact temperature measurements from at least one of: sides of the foot, heel, ankles, tips of toes, top of the toes and the instep;sensing a temperature profile with the non-wearable device of a second foot, the temperature profile comprising contact temperature measurements from similar positions on the second foot as the contact temperature measurements of the first foot; andcomparing the temperature profile of the first foot with the temperature profile of the second foot to determine any variations.

45. The method of claim 44, and further comprising sending an alert when variations outside a range are found.

46. The method of any of claims 44-45, wherein the step of comparing the temperature profile of the first foot with the temperature profile of the second foot to determine any variations comprises:comparing the temperature sensed at a specific position of the first foot with the temperature sensed at the same or mirrored position on the second foot.

47. The method of any of claims 44-46, and further comprisingcomparing sensed measurements to stored data regarding previous temperature measurements at particular positions; andsending an alert when the sensed measurements vary outside a range from the previous temperature measurements.

48. The method of any of claims 44-47, and further comprising identifying erroneous measurements and not including measurements identified as erroneous in any comparing steps.

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