Sensing clothing and manufacturing method thereof

Abstract

A system (100, 200, 300) for monitoring a user comprises: a garment (110, 310, 716, 816, 910) configured to be placed on a foot of a user; a covering (130, 230, 330, 712, 812, 930) coupled to the garment (110, 310, 716, 816, 910); and a sensor arrangement (120, 320, 714, 920) between the garment (110, 310, 716, 816, 910) and the covering (130, 230, 330, 712, 812, 930), wherein the sensor arrangement (120, 320, 714, 920) comprises at least one temperature sensor (124a-124f, 224a-224f) for measuring at least one temperature on a foot of the user. A method (400) for making a system (100, 200, 300) for monitoring a user includes forming a sensor arrangement (120, 320, 714, 920) including at least one sensor lead (122, 222, 1022) coupled to a temperature sensor (124a-124f, 224a-224f), positioning at least a portion of the sensor arrangement (120, 320, 714, 920) on a garment (110, 310, 716, 816, 910) configured to be placed on a foot of a user, and enclosing at least a portion of the sensor arrangement (120, 320, 714, 920) between the garment (110, 310, 716, 816, 910) and a covering (130, 230, 330, 712, 812, 930).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to PCT Application No. PCT / CN2018 / 121244 filed on December 14, 2018, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present invention relates generally to the field of foot care, and more particularly, to new and useful sensing garments and methods of making the same.

[0004] background

[0005] Diabetes is an increasingly common disease in which the body's ability to produce or respond to insulin is impaired. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to serious medical complications that are difficult to treat. For example, one complication of poorly controlled diabetes is foot ulcers, which may not heal due to poor blood circulation in diabetics and because treatment is not always successful in stopping the spread of infection. Foot ulcers in diabetics are painful and, if not resolved, may lead to lower limb amputation. As another example, Charcot foot, also known as Charcot arthropathy, is a debilitating complication of diabetes that involves fractures and dislocations of bone joints that occur with minimal or no known trauma.

[0006] Self-care is essential to detect early signs of ulcers, Charcot foot, and other injuries and allow for prompt treatment. However, visual inspection for detecting such conditions has limitations. For example, patients who are obese or have impaired vision may not be able to see their feet easily. In addition, patients may not be able to feel the early development of foot ulcers and / or fractures due to diabetes-induced neuropathy (numbness or loss of sensation due to nerve damage). Further, X-rays cannot reliably show fractures in their early stages. As a result, painful and dangerous foot conditions may not be detected until they have progressed to a more severe state, which increases the likelihood of extreme treatments such as amputation.

[0007] Therefore, there is a need for new and improved systems and methods for monitoring the health of a patient's feet.

[0008] Overview

[0009] In general, a system for monitoring a user includes: a garment configured to be placed on a foot of the user; a covering coupled to the garment; and a sensor arrangement between the garment and the covering, wherein the sensor arrangement includes at least one temperature sensor for measuring at least one temperature on the user's foot. In some variations, the garment may include a sole area (e.g., a plantar area), and the sensor arrangement may be between the sole area of ​​the garment and the covering. The garment may, for example, include a sock or an insole.

[0010] The sensor arrangement may include a plurality of sensor leads, each of which is coupled to a corresponding temperature sensor. The sensor leads may be arranged into a harness (such as a flat harness) for passing through clothing (e.g., at least the sole area or sole area of ​​clothing). For example, the sensor lead harness may be shaped to follow a curved path. In some variations, one or more sensor leads may include a distal portion bifurcated from the sensor lead harness so that the temperature sensor associated therewith is individually positioned at a desired measurement position on the clothing. In some variations, at least a portion of the harness may be sealed in a film such as a thermoplastic. In some variations, the sensor arrangement may be received in a recessed portion in the sole area of ​​clothing, which may, for example, reduce the final profile of the assembly system and reduce discomfort and / or injury to the user wearing the clothing.

[0011] The temperature sensors in the sensor arrangement can be arranged on the garment in various suitable patterns. In one exemplary variation, the sensor arrangement includes at least one temperature sensor arranged at a location on the sole area of ​​the foot selected from the group consisting of a phalangeal area of ​​the garment, between a phalangeal area of ​​the garment and a metatarsal area, between a metatarsal area of ​​the garment and a tarsal area of ​​the garment, and a heel area of ​​the garment.

[0012] Additionally, in some variations, the garment may further include a housing, wherein the housing surrounds a proximal portion of the sensor arrangement. The housing may further surround at least one of a controller, a wireless communication module, a power source, and a memory.

[0013] The covering may be coupled to the sole area around a perimeter of at least a portion of the sensor arrangement and / or housing, thereby enclosing the sensor arrangement and / or housing between the garment and the covering. In some variations, the covering may include fabric and be configured to be heat sealed to the garment.

[0014] In general, a method for making a user monitoring system includes forming a sensor arrangement including at least one sensor lead, wherein the sensor lead is coupled to a temperature sensor, positioning at least a portion of the sensor arrangement on a garment configured to be placed on a foot of a user, and enclosing at least a portion of the sensor arrangement between the garment and a covering. In some variations, the method may also include removing material from a sole region of the garment to form a recessed portion of the sole region, such that at least a portion of the sensor arrangement may be positioned in the recessed portion of the sole region. For example, the garment may include a sock or an insole.

[0015] In some variations, the sensor arrangement may be formed as a grouped harness of sensor leads, each sensor lead having a corresponding temperature sensor. For example, the sensor arrangement may be formed as a flat harness. The harness may take a variety of shapes. For example, the harness may be shaped to follow a curved path. In some variations, forming the sensor arrangement may include arranging at least one sensor lead so that its distal portion and its corresponding temperature sensor diverge from the harness to position the temperature sensor at a desired measurement location. In some variations, the method may include sealing the sensor arrangement within a film such as a thermoplastic.

[0016] In some variations, enclosing at least a portion of the sensor arrangement includes coupling a cover to a garment. For example, coupling the cover to a garment may include coupling the cover to a sole area around a perimeter of at least a portion of the sensor arrangement. For example, such coupling may be performed by heat sealing. In some variations, the method may further include enclosing a proximal portion of the sensor arrangement in a housing, and coupling the housing to the garment.

[0017] A system for monitoring a user may include: a garment configured to be placed near a body part of the user; a covering coupled to the garment; and a sensor arrangement between the garment and the covering, wherein the sensor arrangement includes at least one sensor for measuring at least one parameter associated with the body part of the user. The at least one parameter measured by the sensor may be any suitable parameter. For example, the at least one parameter measured by the sensor may be temperature, pressure, humidity, strain, user activity, muscle activity, movement, amount of time the garment is worn, orientation, etc. In addition, the garment may include, for example, a sock or an insole. In some variations, the sensor arrangement may include a plurality of sensor leads, each of which is coupled to a corresponding sensor. For example, the garment may include a sole area, and the sensor arrangement may be between the sole area of ​​the garment and the covering. The covering may be coupled to the sole area around the perimeter of at least a portion of the sensor arrangement. The covering may be heat-sealed to the garment. In some variations, the sensor leads may be arranged as a flat harness that passes through the garment. For example, the harness may be shaped to follow a curved path along the garment. In some variations, at least a portion of the harness may be sealed within a flexible membrane. The sensors may be distributed along the plantar region of the garment in any suitable manner. In some variations, the sensor arrangement may include at least one sensor arranged at a location on the plantar region selected from the group consisting of a phalangeal region of the garment, between a phalangeal region of the garment and a metatarsal region, between a metatarsal region of the garment and a tarsal region of the garment, and a heel region of the garment.

[0018] A method for making a user monitoring system may include forming a sensor arrangement including at least one sensor lead, wherein the sensor lead is coupled to a sensor for measuring at least one parameter associated with a body part of a user, positioning at least a portion of the sensor arrangement on a garment configured to be placed near the body part of the user, and enclosing at least a portion of the sensor arrangement between the garment and a covering. For example, the garment may include a sock or an insole. Forming the sensor arrangement may include arranging the sensor leads into a flat harness. In some variations, the method may include shaping the harness to follow a curved path. The at least one parameter measured by the sensor may be any suitable parameter. For example, the at least one parameter measured by the sensor may be temperature, pressure, humidity, strain, user activity, muscle activity, movement, amount of time the garment is worn, orientation, etc.

[0019] Various methods may be used to enclose at least a portion of the sensor arrangement between the garment and the covering. For example, enclosing a portion of the sensor arrangement may include coupling the covering to the garment. In some variations, coupling the covering to the garment may include coupling the covering to the sole area around the perimeter of a portion of the sensor arrangement. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1A and1B 2 are side and bottom views, respectively, of an exemplary variation of a system for monitoring a user.

[0022] Figure 1C is a detailed view of a sensor arrangement and a portion of a housing in an exemplary variation of a system for monitoring a user.

[0023] Figure 1D is an illustrative schematic diagram of sensors and components in a housing in an exemplary variation of a system for monitoring a user.

[0024] Figure 2 is a bottom view of another exemplary variation of a system for monitoring a user.

[0025] Figure 3 is a side view of another exemplary variation of a system for monitoring a user.

[0026] Figure 4 is a flowchart illustration of an exemplary variation of a method for producing a user monitoring system.

[0027] Figure 5 is a graphical representation of a portion of an exemplary variation of a method for making a user monitoring system.

[0028] Figure 6 is a graphical representation of a portion of an exemplary variation of a method for making a user monitoring system.

[0029] Figure 7 and 8 is a graphical representation of a portion of an exemplary variation of a method for making a user monitoring system.

[0030] Fig.9A is a lower perspective view of an exemplary variation of the garment.

[0031] Fig. 9B is an illustrative schematic diagram of components of an exemplary variation of a system for monitoring a user.

[0032] Fig.10 is an illustrative schematic diagram of sensors of an exemplary variation of a system for monitoring a user.

[0033] Figure 11-17 2 are lower perspective, front, back, right side, left side, top and bottom views, respectively, of exemplary variations of the garment.

[0034] Figure 18-24 1 and 2 are, respectively, a lower perspective view, a front view, a rear view, a right side view, a left side view, a top view, and a bottom view of another exemplary variation of a garment.

[0035] Figure 25-311 and 2 are, respectively, a lower perspective view, a front view, a rear view, a right side view, a left side view, a top view, and a bottom view of another exemplary variation of a garment.

[0036] Figure 32-38 1 and 2 are, respectively, a lower perspective view, a front view, a rear view, a right side view, a left side view, a top view, and a bottom view of another exemplary variation of a garment.

[0037] Detailed Description

[0038] Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.

[0039] In general, various systems for monitoring a user and methods for making such systems are described herein. The system may be a garment (e.g., a sock) worn on a user's foot and configured to measure one or more physical characteristics of the user, such as skin temperature at one or more locations on the user's foot. In some variations, the user may wear two garments (including one garment on the user's left foot and another garment on the user's right foot). Temperature measurements may be performed substantially continuously while the garments are worn.

[0040] For example, a diabetic user may suffer from diabetic neuropathy and therefore feel little or no sensation on the user's feet, which limits the user's ability to identify the development of injuries (such as sores, ulcers, infections, or poor blood circulation in the user's feet). If left untreated, such conditions may lead to greater medical complications (such as amputation of one or both feet). However, when an area of ​​the foot is infected, the temperature of the infected area may generally rise as the body fights the infection. Therefore, the system described herein can provide temperature data when worn, which can be analyzed to assess inflammation of the diabetic foot and identify and / or detect the development of diabetic foot complications. In some variations, the sampled temperature difference between corresponding positions on the user's left and right feet can be compared with the baseline temperature difference between the same corresponding positions. A threshold change (e.g., a change of about 4°F or more) between the baseline temperature difference and the sampled temperature difference can indicate, for example, early signs of diabetic foot ulcers. An exemplary method for assessing foot inflammation based on foot temperature measurements from the system is described in U.S. Patent Application Publication No. 2017 / 0188841, which is hereby incorporated herein in its entirety by this reference.

[0041] The system described herein can provide substantially continuous temperature measurement at different positions of the user's foot, which enables more effective prediction and / or detection of diabetic foot conditions compared to conventional assessment methods. Conventional methods for monitoring diabetic foot conditions include using a handheld foot thermometer to measure the temperature at a selected position of the foot. Such tools are designed to measure the temperature once a day or once every long period of time. However, these tools cannot provide a comprehensive temporal and spatial understanding of temperature pattern data. In contrast, continuous monitoring allows the temperature to be assessed over a longer period of time and with a higher temporal resolution, so that micro-patterns (e.g., over the course of an hour or a day) can be considered when assessing the development of the user's foot condition. For example, a once-a-day measurement can capture the temporary temperature characteristics of the user's foot, but subsequent signs of inflammation later in the day caused by the day's activities cannot be captured. In contrast, continuous monitoring can facilitate analysis of user-specific temperature patterns (space and time) for more accurate assessments. In addition, the system herein can be combined with activity data (e.g., from an accelerometer, a pedometer, etc.) so that the analysis can consider the user's activity level that changes over time (and assess how activity affects the temperature pattern). Therefore, continuous monitoring has greater potential to report consistent and clinically relevant temperature increases. Therefore, systems such as those described herein that provide continuous temperature monitoring have the potential to further improve home care and early detection of diabetic foot conditions. Variations of such systems and methods of making such systems are described in further detail below.

[0042] System for monitoring users

[0043] In some variations, such as Figure 1A and 1B As shown, a system 100 for monitoring a user may include a garment 110 configured to be placed on a foot of a user, wherein the garment may include a sole area 112, a cover 130 coupled to the garment 110, and a sensor arrangement 120 between the garment (e.g., the sole area 112 of the garment) and the cover 130, wherein the sensor arrangement includes at least one temperature sensor for measuring at least one temperature on the foot of the user. For example, in some variations, as Figure 1B As shown, the sensor arrangement may include a plurality of temperature sensors 124 arranged in different areas of the garment so as to measure the temperature at different locations on the sole of the user's foot.

[0044] clothing

[0045] The clothing of system 100 provides a base or platform for the sensor arrangement and positions the sensor relative to the user's desired measurement position when the clothing is worn. In some variations, the clothing includes a sock configured to be placed or worn on the user's foot. However, the clothing may alternatively be any suitable component to be positioned on the foot, such as a shoe, a slipper, an insole, etc. For example, in some variations, the clothing may be a shoe or shoe component configured to accommodate the sensor arrangement. For example, a shoe may include an insole configured to receive one or more sensor arrangements. The insole may include one or more sensor arrangements coupled to the insole by a covering. The clothing may be specifically configured for the left foot (e.g., including a toe box that accommodates the left foot profile), for the right foot (e.g., including a toe box that accommodates the right foot profile), or may be universal or suitable for both feet. The clothing may include one or more tags that are sewn, woven, or otherwise incorporated into or coupled to the clothing. Examples of tags include indications of left or right foot compatibility, size (e.g., small, medium, large, or digital size), or other identification information.

[0046] Furthermore, while the methods and systems are described herein primarily with respect to footwear, it should be understood that in other variations, the garment may be any suitable garment (e.g., pants, shorts, tights, leggings, leggings, shirts, arm warmers, gloves, mittens, scarves, hats, headbands, etc.) configured to be placed proximate one or more suitable body parts of a user for monitoring.

[0047] like Figure 1A As shown, in some variations, the garment 110 may include a sole region 112 (e.g., sole region) configured to receive a user's foot and an ankle region 114 extending from the sole region 112. At least the sole region 112 may include a flexible material, such as a fabric (e.g., polyester, cotton, etc.), which is configured to conform to the user's foot so that when the garment is worn, a temperature sensor coupled to the sole region of the garment may be positioned proximate to the user's skin to provide accurate skin temperature measurements. The ankle region 114 may also include a flexible material (e.g., fabric) configured to conform to the user's calf. Additionally or alternatively, the ankle region 114 (and / or other regions of the garment, such as the inside or outside of the foot portion of the garment, the top or back region of the foot portion of the garment, etc.) may include one or more temperature sensors (and / or other types of sensors) for providing skin temperature measurements. For example, one or more sensors may be arranged on the garment to measure the skin temperature of the ankle and / or leg (e.g., calf).

[0048] In some variations, the sole region 112 and / or the ankle region 114 may include one or more recessed portions for receiving at least a portion of the sensor arrangement. The recessed portion may be located on the inner surface of the garment or on the outer surface of the garment. The depth of the recessed portion may be similar to (e.g., approximately equal to) or greater than the thickness of the sensor arrangement, so that when the sensor arrangement is received in the recessed portion, the sensor arrangement does not significantly extend beyond the contour of the garment material. Therefore, one or more recessed portions on the sole region of the garment can advantageously help reduce local pressure points (thereby reducing the development or worsening of foot injuries caused by the user stepping on the sensor arrangement) and / or reduce the possibility of damage to the sensor arrangement.

[0049] The recessed portions may be formed in any suitable manner. For example, a garment may be typically made of plush or thickened material (e.g., terry knit), which may increase comfort for the user, and the garment may include one or more recessed portions formed by reducing some thickness of the material in selected areas corresponding to the final location of the sensor arrangement on the garment. Alternatively, the garment may be woven or knitted to have different thicknesses (including thinner portions forming one or more recessed portions). In some variations, one or more recessed portions may be patterned to have a shape similar to the shape of the sensor arrangement. For example, as Figure 1B As shown, the recessed portion (below the cover 130) may generally resemble the outline or path of the sensor lead 122 of the sensor arrangement. Figure 1A As shown, the recessed portion (below the cover 130) may have a straight path that follows the path of the sensor lead 122, which extends from the sole area 112 of the garment to the ankle area 114 of the garment. In other words, the contour of the recessed portion 116 may substantially correspond to the contour of the sensor arrangement. In some variations, the recessed portion 116 may extend beyond the contour of the sensor arrangement by an additional margin (e.g., at least about 0.5 cm). Such additional margin may, for example, take into account tolerances in the size and shape of the sensor arrangement received in the recessed portion 116, and / or allow for some room for movement (e.g., bending) of the sensor lead when the garment is stretched, repositioned, etc.

[0050] However, alternatively, one or more recessed portions may have any suitable shape (e.g., a suitable shape that extends beyond the perimeter of the sensor arrangement). Figure 2 In the variation shown in , the recessed portion receiving the sensor arrangement may have a generally rectangular shape similar to the cover 230.

[0051] shell

[0052] In some variations, the garment may further include at least one shell 140. Figure 1CAs shown, the housing 140 may include at least one cavity 142 for receiving the proximal end of the sensor arrangement 120, as further described below, and / or accommodating various other components. For example, the housing 140 may be arranged on the ankle area of ​​the clothing. In some variations, the housing 140 may be located on the outside of the clothing. The outer positioning of the housing can make the housing comfortable to use (for example, because the housing positioned on the outside of the clothing is unlikely to interfere with walking and other activities). However, in other variations, the housing may be located on any suitable part of the clothing (for example, the inside, front side, back side, far side, etc.). In some variations, the housing 140 can be fixed to the clothing by being enclosed between the clothing and the covering (similar to the sensor arrangement described below). Additionally or alternatively, the housing can be coupled to the clothing with adhesives or mechanical fasteners (for example, rivets, snaps, etc.), inserted into pockets or other containers on the clothing, sewn to the clothing, or coupled to the clothing in any suitable manner.

[0053] The housing can be substantially sealed (e.g., airtight or waterproof) to protect the contents of the housing from environmental conditions (e.g., when the garment is washed or worn, when the user sweats, etc.). For example, the cavity 142 can be filled and / or otherwise sealed with a substance that adheres to the housing 140 (such as UV glue, silicone, other epoxy or polymer, etc.). Such a substance can help secure the proximal end of the sensor arrangement 120 and / or other components within the housing 140. As another example, the housing 140 can include one or more components that can be coupled together (e.g., via a suitable mechanical interface (interfit), fasteners, welds, etc.). The joints between the coupled housing components can be sealed with epoxy or other suitable sealants. In some variations, one or more components of the housing can be formed at least in part by injection molding.

[0054] like Figure 1D As shown in the schematic diagram of , the housing 140 may house various components for operating the system. For example, the housing 140 may include at least one processor 152 (e.g., a CPU), at least one storage device 154 (which may include one or more computer-readable storage media), at least one communication module 156, and at least one power supply 158. In some variations, the housing may also include one or more additional activity or other sensors (e.g., an accelerometer, a gyroscope, or an inertial measurement unit). One or more of these components may be arranged on one or more electronic circuit boards (e.g., a PCBA), which in turn is mounted to the housing.

[0055] The processor 152 and the memory device 154 may cooperate to provide a controller for operating the system. For example, the processor 152 may receive sensor data from one or more sensors 124 (e.g., a first temperature sensor 124a, a second temperature sensor 124b, a third temperature sensor 124c, etc.), and the sensor data may be stored in one or more memory devices 154. In some variations, the processor 152 and the memory 154 may be implemented on a single chip, while in other variations, they may be implemented on separate chips.

[0056] The controller can operate in an inactive state and an active state. For example, the controller can switch between an inactive state and an active state based on a user input (e.g., pressing a button) suggesting that the garment be placed on the user and / or sensor data (e.g., data from an active sensor, processing of temperature data, etc.). In an inactive state, the controller can be in a "sleep" mode (e.g., to save energy in the power supply 158). In an active state, the controller can be in a "wake-up" mode, where sensor data is received, processed and / or stored in a storage device 154 for monitoring inflammation. For example, in its active state, the controller can scan at least some temperature sensors to receive and store temperature measurement data (e.g., periodically, such as every second, every 10 seconds, every 30 seconds, every minute, every hour, or other suitable intervals). In general, when there is an indication that the user is not wearing the garment, the controller can operate in an inactive state, and when there is an indication that the user is wearing the garment, the controller can operate in an active state. In some variations, the controller may be similar to the controller described in the U.S. Patent No. 20170188841 incorporated by reference above.

[0057] The communication module 156 can be configured to transmit sensor data and / or other information to an external computing device 170. The external computing device 170 can be, for example, a mobile computing device (e.g., a mobile phone, a tablet computer, a smart watch), a laptop computer, a desktop computer, or other suitable computing device. The external computing device 170 can execute a native application for presenting sensor data (and / or analysis results thereof) to a user through a user interface. Additionally or alternatively, the communication module 156 can be configured to communicate with one or more networked devices (such as a hub paired with the system, a server, a cloud network, etc.).

[0058] The communication module 156 can communicate via a wired connection (e.g., including a physical connection such as a cable with a suitable connection interface (such as USB, mini-USB, etc.)) or a wireless network (e.g., via NFC, Bluetooth, WiFi, RFID, or any type of digital network that is not connected by a cable). For example, devices may communicate directly with each other in a paired connection (1:1 relationship) or a frame relay or broadcast connection (one-to-many or 1:m relationship). As another example, devices may communicate with each other via a mesh network connection (e.g., a many-to-many or m:m relationship), such as via a Bluetooth mesh network. Wireless communications may use any of a number of communication standards, protocols, and technologies, including, but not limited to, Global System for Mobile Communications (GSM), Enhanced Data GSM Environment (EDGE), High Speed ​​Downlink Packet Access (HSDPA), High Speed ​​Uplink Packet Access (HSUPA), Evolution, Data Only (EV-DO), HSPA, HSPA+, Dual Cell HSPA (DC-HSPDA), Long Term Evolution (LTE), Near Field Communication (NFC), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth, Wireless Fidelity (WiFi) (e.g., IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE 802.11d, IEEE 802.11e, IEEE 802.11f, IEEE 802.11g ... 802.11n, etc.), or any other suitable communication protocol. Some wireless network deployments may combine networks from multiple cellular networks, or use a mix of cellular, Wi-Fi, and satellite communications.

[0059] In addition, the housing may include one or more power sources 158 that can be used to provide electrical power to the processor, communication module, sensor, and / or any other electrical components. For example, the power source 158 may include one or more batteries. In some variations, the power source 158 may be rechargeable, such as by wireless charging methods (e.g., inductive charging, RF coupling, etc.) or by utilizing kinetic energy (such as kinetic energy generated by motion (e.g., when a user walks in the garment)).

[0060] Sensor placement

[0061] like Figure 1A and 1BAs shown, the sensor arrangement 120 may be positioned on the garment 110 (such as the inner surface of the garment). When the garment 110 is placed on the user's foot, the sensor arrangement 120 is used to collect measurements (including skin temperature measurements of the user). Although the following description refers to a sensor arrangement including a temperature sensor, the sensor arrangement may include any suitable type of sensor, such as a pressure sensor, a humidity sensor, a strain sensor, a weight sensor, a motion / activity sensor, a muscle activity (e.g., EMG) sensor, an orientation sensor, a sensor that tracks the amount of time the garment is worn (e.g., to determine dependency on a treatment plan), etc. In addition, the sensor arrangement may include more than one type of sensor (e.g., the sensor arrangement may include a temperature sensor and a strain sensor).

[0062] The sensor arrangement 120 may include one or more sensor leads 122, each of which is coupled to a corresponding temperature sensor 124. The temperature sensor 124 may be located at the distal end of its corresponding sensor lead. For example, the sensor arrangement 120 may include one or more thermistors, thermocouples, or other suitable temperature sensors. In some variations, some or all of the sensor leads 122 may be coated with a material such as a fabric (e.g., a polyester sleeve), which may, for example, increase the overall strength of the sensor leads and help prevent failures due to applied stress.

[0063] Typically, the sensor leads 122 may be grouped together (e.g., into a harness), which may have multiple advantages. For example, the increased collective volume (e.g., increased cross-sectional area) of the grouped sensor leads 122 may be less susceptible to stresses imposed on the sensor arrangement (e.g., when the weight of the user is placed on the sensor arrangement, when the garment is stretched, etc.) than a single lead. Therefore, the grouping or harnessing of the sensor leads 122 may make the sensor arrangement 120 more robust and less prone to failure. In addition, the grouping of the sensor leads 122 allows the sensor leads to be easily manipulated together during assembly, thereby making the assembly of the system (e.g., the positioning of the sensor arrangement on the garment) easier and faster than assembling with separate sensor leads. In some variations, the harness may be a flat harness with a low profile. For example, a group of sensor leads 122 may be arranged side by side in a single layer in a flat harness. Such a flat harness may be, for example, more comfortable underfoot for the wearer of the garment.

[0064] In some variations, the sensor arrangement 120 may be positioned on a garment (typically within one or more recessed portions of such garment). Figure 1AIn the exemplary variation shown, the proximal end of the sensor arrangement 120 can be received in the housing, wherein the proximal ends of the sensor leads 122 can be coupled (e.g., soldered) to corresponding signal receiving pins on a processor or other component. In some variations, the sensor arrangement 120 can extend from the housing 140 along the ankle region 114 of the garment 110, wrap around the outside of the garment toward the sole region 112 of the garment, such as Figure 1B As shown. In some variations, the sensor arrangement may be wrapped around the heel area of ​​the garment as the sensor arrangement extends toward the sole area. The sensor lead 122 may pass through the sole area 112 of the garment in any suitable path to position the temperature sensor (at the distal end of the sensor lead 122) at the desired measurement location. As described in further detail below, in some variations, the sensor arrangement may be fixed to the garment via a cover coupled to the garment. However, the sensor arrangement may additionally or alternatively be fixed to the garment by epoxy or other adhesives, sutures, connectors or fasteners, etc.

[0065] In some variations, the sensor arrangement may form a tortuous path as it extends from the housing to the sole area of ​​the garment. Fig.9A and 9B In the exemplary variation of the garment 910 shown, the proximal end of the sensor arrangement 920 is received by the housing 940, and the sensor arrangement 920 extends from the housing 940 along the ankle region 914 toward the sole region 912 of the garment. In this variation, when the sensor leads extend along the ankle region of the garment, the sensor leads are combined together in the form of a harness, and the corresponding sensor leads are branched to various locations along the sole region 912 of the garment (e.g., to the desired sensing location). Fig.9A As shown, the sensor arrangement 920 passes through the heel area 916 of the garment in a curved configuration. The sensor arrangement 920 is wrapped around the heel area 916 of the garment in a substantially "S"-shaped configuration. The curved configuration of the sensor arrangement 920 can provide the benefit of reducing the strain on the sensor arrangement. For example, the curved configuration of the sensor arrangement provides additional length of the sensor so that when the garment is stretched (e.g., when the user puts on or takes off the garment), the curved portion is straightened, rather than the sensor arrangement being placed under strain. Therefore, the curved portion of the sensor arrangement introduces a form of slack so that the garment can be stretched without damaging the sensor arrangement.

[0066] Fig. 9B A schematic diagram of an exemplary sensor arrangement 920 having a curved configuration is shown (with Fig.9AIn this variation, sensor arrangement 920 includes a plurality of sensor leads, with the proximal end of each sensor lead received by housing 940. Each sensor lead 922 in this arrangement includes a sensor 924 (eg, a temperature sensor) at the distal end of the lead. Fig. 9B The sensor arrangement includes a plurality of curved sections. The curved sections may be bent at any suitable angle to traverse to the desired sensor location. Fig. 9B In the embodiment, the bend is configured to bypass the high bend area of ​​the heel region 916 to avoid excessive strain on the sensor leads. Fig. 9B In the illustrated variation, the sensor arrangement includes a curve having angles A and B configured to curve around one or more high-flex regions of the heel region 916 of the garment 910. Angle A may be, for example, between about 65 and about 90 degrees, between about 70 and about 80 degrees, or about 78 degrees. Angle B may be, for example, between about 40 and about 60 degrees, between about 45 and about 55 degrees, or about 51 degrees.

[0067] although Fig.9A and 9B The sensor arrangement 920 in FIG. 1 forms a substantially S-shaped path, but any curved configuration may provide similar benefits, namely reducing the effects of strain on the sensor arrangement and bypassing areas of the garment that may experience high bending and / or strain. In addition, the sensor arrangement may have a curved configuration along any suitable portion of the garment. Although Fig.9A The curved portion of the sensor arrangement 920 is shown extending along the heel region 916 of the garment 910, but the curved portion may be located at any suitable location along the garment. For example, in some variations, the sensor device may include a curvature along its entire path along the ankle region of the garment.

[0068] In some variations, the sensor leads may be housed in a protective material. Fig. 9B In the variation shown, the sensor leads may be bundled and contained within a protective flexible film 950 (e.g., a plastic such as a polyurethane film) (e.g., sealed between two layers of film 950). The protective film 950 may provide the benefit of protecting the sensor from damage and / or external moisture, and may be waterproof or water resistant. Fig. 9BThe sensor arrangement 920 of the garment 910 may also be included in a covering 930. The covering may couple the sensor leads to the garment 910 and guide the sensor leads along a path from the ankle region 914 to the sole region 912 of the garment 910. The shape of the membrane 950 and / or covering 930 may closely approximate the curved shape of the sensor arrangement 920. In some variations, the covering 930 may be a recessed portion or a covered portion of a garment (such as, for example, a recessed portion or a covered portion of a sock or a shoe).

[0069] return Figures 1A-1D In general, the sensor leads 122 may be arranged to distribute the temperature sensors 124 between various discrete target areas of the garment so as to measure the skin temperature at different locations of interest when the garment is placed on the user's foot. In some variations, the measurement locations of interest may include locations that typically experience high pressure when the user is active (e.g., walking or standing). For example, the sensor arrangement may be configured to arrange one or more temperature sensors on the sole area of ​​the garment. In an exemplary variation, the temperature sensor 124 may include six temperature sensors. One temperature sensor 124a may be positioned in a first area of ​​the garment, the first area being configured to contact the phalanges or toes of the foot. For example, the temperature sensor 124a may be configured to contact the skin covering the first phalange ("big toe") of the foot. Three temperature sensors 124b, 124c, and 124d may be positioned in a second area of ​​the garment, the second area being configured to contact the skin covering the boundaries of the phalanges and metatarsals of the foot. For example, temperature sensors 124b, 124c and 124d may be configured to contact the skin near the first (most medial) metatarsal, the third metatarsal and the fifth metatarsal respectively. In addition, another temperature sensor 124e may be positioned in the third region of clothing, which is configured to contact the skin of the border of the metatarsal and tarsal covering the foot. In addition, another temperature sensor 124f may be positioned in the fourth region of clothing, which is configured to contact the skin of the heel covering the foot. In the case where clothing is configured to be placed on the left foot, the configuration of the temperature sensor may be biased towards the left foot, and in the case where clothing is configured to be placed on the right foot, the configuration of the temperature sensor may be biased towards the right foot.

[0070] In other variations, the sensor arrangement may be configured to additionally or alternatively arrange one or more temperature sensors on other areas of the garment (e.g., the inside or outside of the foot region of the garment, the dorsal portion of the foot region of the garment, the ankle region of the ankle, etc.).

[0071] When positioning the temperature sensor at its respective measurement location, the sensor lead 122 may follow a tortuous path through the sole area, which may, for example, provide additional strain relief for the sensor arrangement (e.g., the tortuous pattern may better withstand stretching, etc.). For example, the tortuous path may generally be an "S" shape, a serpentine shape, or other suitable non-linear path. In some variations, such as Figure 1B As shown, the distal ends of one or more sensor leads 122 (and their temperature sensors) may be bifurcated or branched from the sensor lead harness so that the temperature sensors attached to the bifurcated sensor leads are independently positioned at desired measurement locations. Additionally or alternatively, at least a portion of the sensor lead harness may be serially routed through the sole region 112 between different measurement locations so that at least some of the sensor leads are not substantially bifurcated or branched from the main harness. For example, Figure 2 A variation is shown in which the sensor lead wire harness for the temperature sensors 224a-224e is navigated in series to five measurement locations, with the individual sensor leads simply terminating at the measurement location of their respective sensor. In this example, some of the sensor leads may be shorter than others. Figure 2 In the example of , the sensor leads for temperature sensor 224f are bifurcated from the main sensor lead harness, while the other sensor leads are not substantially bifurcated. However, it should be understood that there are many suitable configurations in which the sensor leads pass through the sole area of ​​the garment to position the temperature sensor at the desired measurement location. For example, the distal ends of none, some, or all of the sensor leads (in any combination) may be bifurcated from the main sensor lead harness to locate the corresponding temperature sensor. In addition, none, some, or all of the sensor leads (in any combination) may be navigated in series (in any arrangement or order) in a non-bifurcated manner to the measurement location to locate the corresponding temperature sensor.

[0072] In some variations, the sensor lead may have a coiled or serpentine configuration near the distal end of the sensor. Fig.101 is a schematic diagram of a distal end of a sensor lead 1022 and a sensor 1024 coupled to the distal end of the sensor lead. In this variation, the sensor lead 1022 includes a serpentine configuration 1023 near the distal end. As described above, arranging the sensor lead in a curved configuration can provide strain relief to the sensor arrangement and reduce the risk that the sensor lead will be damaged. In some variations, the serpentine configuration at the distal end of the sensor lead may be more tightly curved than the bends of the sensor lead elsewhere. Due to pressure and movement of the sensor, the sensor lead may be placed under higher levels of strain at its distal end near the sensor. Therefore, the distal end of the sensor lead may be more susceptible to breaking or other forms of damage than other portions of the sensor lead. Therefore, a curved portion (e.g., a curl or serpentine configuration) at the distal end of the sensor lead near the sensor may be beneficial.

[0073] In some variations, the relative position and orientation of some or all of the sensor leads (and, accordingly, the relative position of the individual sensors) may be fixed with additional components. For example, once arranged in a configuration as described above, at least some of the sensor leads may be coupled to one another with epoxy or fasteners (e.g., cable ties, clips, etc.). Additionally or alternatively, at least some of the sensor leads may be sealed together, such as sealed between multiple layers (e.g., upper and lower layers) of film or vacuum sealed in a bag. Suitable films may be, for example, polyurethane or other polymer layers. Thus, such sealing of the sensor arrangement may provide us with an arrangement of the sensor leads 122 (including the grouping or wiring of the sensor leads, and the relative positions of the sensors) during assembly.

[0074] Covering

[0075] In general, the system may also include at least one cover 130 coupled to the garment 110 such that the sensor arrangement and / or housing is located between the garment and the cover. In some variations, attaching the cover 130 to the garment 110 may thereby secure the sensor arrangement and / or housing to the garment. The cover may be coupled to the inner surface of the garment over the sensor arrangement and / or housing positioned on the inner surface of the garment. Alternatively, the cover may be coupled to the outer surface of the garment over the sensor arrangement and / or housing positioned on the outer surface of the garment.

[0076] In some variations, the covering may include a single piece. Alternatively, the covering may include multiple pieces that collectively enclose the sensor arrangement on the garment. For example, the covering may include an ankle covering portion that is sized and shaped to secure the ankle portion of the sensor arrangement 120 and / or the shell to the ankle region 114 of the garment, and a sole covering portion that is sized and shaped to secure the sole portion of the sensor arrangement 120 to the sole region 112. In this example, the ankle covering portion and the sole covering portion may be coupled to each other and then coupled to the garment together, or may be coupled to the garment separately and individually. It should be understood that the covering may include any suitable number of covering segments that collectively cover the sensor arrangement and / or the shell.

[0077] For example, Figure 1A and 1B As shown, cover 130 may be attached to garment 110 around the perimeter of at least a portion of sensor arrangement 120. In some variations, the shape of the cover may be very similar to the shape of sensor arrangement 120 (e.g., slightly larger than the outline of the sensor arrangement, such as by at least about 0.5 cm).

[0078] Alternatively, in some variations, the cover may have any suitable shape and size that is larger than the outline of the sensor arrangement 120. For example, Figure 2 As shown, the system 200 may include a covering 230 that may be generally rectangular and larger than the total area of ​​the sensor arrangement on the sole area of ​​the garment. In other variations, the covering 230 may be oval, circular, or other suitable shapes. As another example, Figure 3 As shown, system 300 may include a covering 330 that provides a second layer to a substantial portion of garment 310 (e.g., the sole area and at least a portion of the ankle area) such that sensor arrangement 320 is layered between ("sandwiched" or laminated between) the garment and the covering.

[0079] The covering may include any of a variety of suitable materials. For example, the covering may include a fabric (e.g., polyester, cotton, etc.) cut into a desired shape. In some variations, such a fabric covering may be lined with a material suitable for heat sealing the covering to the garment, such as a thermoplastic material (e.g., thermoplastic polyurethane). Additionally or alternatively, the fabric covering may be coupled to the garment with an epoxy or other adhesive, sutures, and / or fasteners (e.g., rivets). In other variations, the covering may include an epoxy or other adhesive (e.g., silicone glue), or sewing thread (e.g., embroidery) that directly secures the sensor arrangement to the garment.

[0080] Other aspects of making the user monitoring systems described herein are described in further detail below.

[0081] Method for manufacturing a user monitoring system

[0082] In some variations, such as Figure 4 As shown, the method 400 for manufacturing a user monitoring system includes 420 forming a sensor arrangement including at least one sensor lead, 430 positioning at least a portion of the sensor arrangement on an area of ​​clothing (e.g., a sole area), and 440 enclosing at least a portion of the sensor arrangement between the area of ​​clothing and a covering. In some variations, the method 400 may also include 410 preparing clothing to receive the sensor arrangement, as further described below, but in some variations, the clothing may be prepared in advance and configured to receive the sensor arrangement. Typically, the method 400 may be performed to enable at least a portion of the above-mentioned system to be used for monitoring a user. Although the method is primarily described with reference to manufacturing foot-borne clothing such as socks, it should be understood that variations of the method 400 may be used to manufacture similar monitoring systems with other clothing or for other body parts (e.g., slippers, insoles, gloves, pants, shirts, etc.).

[0083] Prepare your clothing

[0084] Figure 5 Aspects of preparing garments are generally shown 410. Figure 5 As shown, the garment can be prepared by forming one or more recessed portions 116 of the garment 110, wherein one or more recessed portions can be configured to receive the sensor arrangement and reduce the overall profile of the garment, which would otherwise be increased due to the sensor arrangement. For example, the garment may include a plush material (e.g., a terry knit) that can be thinned or cut shorter (e.g., using a cutting blade, scissors, a razor, etc.) in a selected area where a recessed portion is required. In some variations, one or more recessed portions 116 of the garment may be arranged on the inner (skin contact) surface of the garment. For example, the garment may be turned inside out to allow access to the inner surface of the garment, and the inner surface of the garment may be trimmed to form the recessed portion 116. The garment may be kept inside out to position and couple the sensor arrangement and cover to the inner surface of the garment, as described below. In other variations, one or more recessed portions 116 may be arranged on the outer surface of the garment.

[0085] like Figure 5 As shown in the variations of , the recessed portion 116 can generally resemble the footprint or shape of the sensor arrangement (e.g., a branching pattern on the sole area of ​​the garment 110, with bifurcated branches or lobes corresponding to the sensor locations). However, the recessed portion 116 can have any suitable size and shape for receiving at least a portion of the sensor arrangement. For example, additional patterns for recessed portions are described above.

[0086] Forming sensor layout

[0087] Figure 6 Aspects of forming a sensor arrangement 620 are generally shown. For example, the sensor arrangement can be formed at least in part by arranging individual sensor leads into a harness 610 or other grouping. The harness can be, for example, a flat harness having a low profile (e.g., the sensor leads are arranged side by side in a single layer). The harness can be shaped to have any suitable number of sensor leads with distal ends branching from the harness for separately positioning temperature sensors coupled to the distal ends of the sensor leads. Various examples of sensor lead configurations are described in further detail above.

[0088] There are several suitable methods for arranging the sensor leads into the harness 612. In one exemplary variation, the sensor leads may be arranged (e.g., manually or automatically using a tool, etc.) with the help of a fixture having one or more open channels (e.g., grooves) that are shaped to resemble the desired sensor lead layout. The sensor leads may be placed in the open channels, which gather and shape the sensor leads into a desired shape. Similarly, in another exemplary variation, the fixture may include one or more closed channels (e.g., lumens) shaped to resemble the desired sensor lead layout. In this variation, the sensor leads may be fed longitudinally into the closed channels, which similarly gather and shape the sensor leads into a desired shape. In yet another exemplary variation, the sensor leads may be manually arranged on a surface in a free-form manner. The surface may include, for example, contour lines or reference marks to guide the placement of the sensor leads.

[0089] In some variations, after the sensor leads are arranged into a wire bundle 612 or other suitable pattern, the arrangement may be sealed or otherwise configured to fix the relative positions of the sensor leads. Figure 6 As shown, at least a portion 632 of the arranged sensor leads can be laminated between layers of thermoplastic films 622 and 624 (e.g., thermoplastic polyurethane or other thermoplastics) (such as by heat sealing). Other examples of securing the sensor arrangement include sealing in a bag (e.g., vacuum sealing), and coupling the sensor leads together with adhesives, fasteners, filaments, etc.

[0090] The proximal ends 630 of the sensor leads in the sensor arrangement may remain exposed (unsealed) to allow electrical connections for sensor data communication. Figure 6As shown, the proximal ends of the sensor leads can be connected (e.g., soldered) to pins of one or more processors or other suitable connectors in the housing 634. The connections between the sensor leads and the processor can be protected by applying a substance (e.g., UV glue, silicone glue, putty, etc.) over the electrical connections and / or other connection areas to the housing.

[0091] Forming a covering

[0092] In some variations, the covering may include a flexible material that can be formed into a suitable shape for covering the sensor arrangement and coupling to the garment. The covering may include a single or multiple parts. In an exemplary variation, the covering may include a material that facilitates heat sealing, such as a fabric (e.g., polyester or other suitable fabric) lined with a thermoplastic (e.g., thermoplastic polyurethane). However, in other variations, the covering may include a fabric that can be coupled to the garment via epoxy, fasteners, etc. in other ways. Typically, the fabric covering can be formed by cutting the covering shape from the fabric (e.g., with scissors, laser cutting, etc.). Templates, clamps, and / or other suitable tools can be used to facilitate precise cutting of the covering shape. Suitable exemplary covering shapes are described in further detail above.

[0093] Assembling the garment and sensor placement

[0094] Figure 7 and 8 Aspects of a variation of assembling a garment and sensor arrangement are generally shown. Specifically, Figure 7 An exemplary process of enclosing a sensor arrangement between a sole region of a garment and a cover lined with a thermoplastic or similar material suitable for heat sealing is shown. At least the sole region of garment 716, the sole portion of sensor arrangement 714, and the sole portion of cover 712 can be stacked and aligned such that the sole portion of the sensor arrangement is contained between the garment and the cover.

[0095] Various processing devices can be added to the stack of system components. A forming block 710 can be placed on the cover 712, wherein the forming block 710 has a contact surface that defines the location where the heat seal will be applied. The forming block 710 may include a raised outer edge similar to the periphery of the sensor arrangement (with an additional sufficient margin, such as about 0.5 cm or greater). The forming block 710 may include a recessed portion corresponding to the shape of the sensor arrangement (or a recessed area that is at least as large as the sensor arrangement) so that the forming block protects the sensor arrangement from damage during subsequent compression of the assembled stack. In addition, in some variations, a thermally conductive mold insert 718 can be inserted into the garment so that it provides a backing behind the sensor arrangement. For example, the mold insert 718 can be made of steel.

[0096] In order to heat seal the cover to the garment, it may be beneficial to flatten the garment, for example, to prepare for the stacking of the system components used in the heat sealing as described above. The garment can be flattened in any suitable manner. For example, the garment can be flattened from top to bottom so that the sole portion of the garment is stacked on the top of the ankle portion. In another variation, the garment can be flattened from side to side so that the left side of the garment is stacked on the top of the right side, and vice versa. Flattening the garment from side to side when preparing for heat sealing can provide the benefit of avoiding wrinkles or creases in the ankle region of the garment.

[0097] Heating and compression can be applied to the assembly stack of system components and processing devices. For example, the mold insert 718 can be heated (e.g., via an accessible portion of the mold insert). At the same time, the stack can be compressed (e.g., using a clamp, a vise, or a similar device) so that the heat from the mold insert 718 causes a seal between the thermoplastic lining of the cover and the garment. In addition to or in lieu of heating and compression, the cover can be coupled to the garment by other suitable means (such as by sewing or with fasteners). After this process, the sensor arrangement 714 is enclosed between the sole area of ​​the garment 716 and the cover 712.

[0098] Figure 8 An exemplary process of enclosing a sensor arrangement and / or housing between the ankle region and the covering is shown. In general, the process may be similar to that described above with reference to Figure 7 The described process, except that the assembled stack of system components includes the ankle area of ​​clothing 816, the ankle portion of sensor arrangement 814 and / or shell 815, and the ankle area of ​​covering 812, which are aligned so that the ankle portion of sensor arrangement is contained between clothing and covering. The molding block 810 may include a raised outer edge similar to the periphery of the sensor arrangement and / or shell (with additional sufficient margin), and a recessed portion that protects the sensor arrangement during compression. Similar to what is described above, heating and compression can be applied to the assembled stack. As a supplement or alternative to heating and compression, the covering can be coupled to the clothing by other suitable means (such as by sewing or with fasteners). After the process, the sensor arrangement 814 is enclosed between the ankle area of ​​clothing 816 and covering 812.

[0099] In some variations, the mold inserts 718, 818 may be omitted from the stack. In variations, any other rigid backing (such as a flat workspace surface) may support compression and / or provide heating. Figure 7 and Figure 8 The processes are shown as separate steps, but it will be understood that the garment may be arranged in a manner that allows these heat sealing processes to occur substantially in parallel.

[0100] Finally, if the garment has been turned inside out to facilitate assembly of the sensor arrangement, the garment can be turned inside out again to return the garment to its intended wearable state.

[0101] Example

[0102] Fig.9A and 11 -38 depicts multiple variations of a system for monitoring a user (including a garment configured to be placed on a user's foot). The exemplary garment includes a sensor arrangement extending from an ankle region of the garment to a sole region of the garment, wherein each sensor lead in the arrangement is coupled to a sensor on the sole region of the garment that is configured to measure the temperature of the user's foot. Fig.9A and 11 The sensor arrangement of the garment depicted in -38 includes a curved configuration along the heel area of ​​the garment. Fig.9A and 11 -38 The garment depicted may be manufactured using any suitable method, such as that described above. For example, the sensor arrangement may be coupled to the garment by placing the sensor arrangement within a cover and heat sealing the cover to the garment. As described above, the sensor arrangement may also be placed in a protective film prior to being coupled to the garment. The housing may be attached to the garment in any suitable manner (e.g., by placing the housing within the cover and heat sealing the cover to the garment using an adhesive mechanism such as a snap fit). Fig.9A In the embodiment of the present invention, the housing 940 is a box-shaped component with a rectangular cross-section located on the ankle area 914 of the garment 910, however, the housing can include any suitable size, shape, and location. The proximal ends of the sensor leads can be coupled to the housing in any suitable manner (e.g., using epoxy to couple the leads and seal them to the housing).

[0103] In some variations, the garment may include markings to indicate which foot the garment is intended to be worn on. In other variations, the garment may not include markings to indicate which foot the garment is intended to be worn on. For example, Figure 11-17 depicts various views of a garment configured to be worn on a right foot (with optional foot indicator markings), and Figure 18-24 Various views of a garment configured to be worn on a left foot (with optional foot indicator markings) are depicted. Figure 25-31 Various views of a garment configured to be worn on a right foot are depicted, wherein the garment includes a foot indicator mark ("R") indicating that the garment is intended to be worn on a right foot. Figure 32-38Various views of a garment configured to be worn on a left foot are depicted, wherein the garment includes a foot indicator mark ("L") indicating that the garment is intended to be worn on a left foot. The foot indicator mark may be affixed to the garment in any suitable manner. For example, a mark (e.g., "R" or "L") indicating to a user on which foot the garment is intended to be worn (e.g., Fig.28 and 36 as shown), may be knitted or embroidered into a garment, may include patches sewn onto or otherwise attached to a garment, appliques ironed on or otherwise attached to a garment, may be made using fabric dyes, etc.

[0104] For the purpose of explanation, the above description uses specific terms to provide a thorough understanding of the present invention. However, it is obvious to those skilled in the art that specific details are not required in order to practice the present invention. Therefore, for the purpose of illustration and description, the foregoing description of specific embodiments of the present invention is presented. They are not intended to be exhaustive or to limit the present invention to the precise form disclosed; obviously, in view of the above teachings, many modifications and variations are possible. The embodiments are selected and described in order to explain the principles of the present invention and its practical application, so that other persons skilled in the art can utilize the present invention and various embodiments with various modifications suitable for the intended specific use. The attached claims and their equivalents are intended to define the scope of the present invention.

[0105] Aspects of the present disclosure may be implemented in one or more of the following embodiments:

[0106] 1) A method for manufacturing a user monitoring system, the method comprising:

[0107] forming a sensor arrangement comprising at least one sensor lead, wherein the sensor lead is coupled to a temperature sensor;

[0108] positioning at least a portion of the sensor arrangement on a garment configured to be placed on a foot of a user; and

[0109] At least the portion of the sensor arrangement is enclosed between the garment and the covering.

[0110] 2) The method according to 1) further includes removing material from the sole area of ​​the garment to form a recessed portion in the sole area, wherein positioning at least a portion of the sensor arrangement includes positioning at least a portion of the sensor arrangement in the recessed portion of the sole area.

[0111] 3) The method of 1), wherein forming the sensor arrangement includes arranging the sensor leads into a flat wire bundle.

[0112] 4) The method according to 3), wherein the wire harness is shaped to follow a curved path.

[0113] 5) The method of 3), wherein the sensor arrangement comprises a plurality of sensor leads, and forming the sensor arrangement comprises arranging at least one sensor lead such that a distal portion thereof and its corresponding temperature sensor diverge from the wiring harness.

[0114] 6) The method of 1), wherein enclosing at least the portion of the sensor arrangement comprises coupling the covering to the garment.

[0115] 7) The method according to 6) further comprising sealing the sensor arrangement within a polymer film before coupling the covering to the garment.

[0116] 8) The method of 6) wherein coupling the covering to the garment comprises coupling the covering to a sole area of ​​the garment around a perimeter of at least a portion of the sensor arrangement.

[0117] 9) The method of 6) wherein coupling the cover to the garment comprises heat sealing the cover to the garment.

[0118] 10) The method according to 1), further comprising enclosing a proximal portion of the sensor arrangement in a housing and coupling the housing to the garment.

[0119] 11) The method according to 1), wherein the garment is socks.

[0120] 12) A system for monitoring a user, the system comprising:

[0121] a garment configured to be placed on a foot of the user;

[0122] a cover coupled to the garment; and

[0123] A sensor arrangement is provided between the garment and the covering, wherein the sensor arrangement comprises at least one temperature sensor to measure at least one temperature on a foot of the user.

[0124] 13) The system according to 12), wherein the sensor arrangement comprises a plurality of sensor leads, each sensor lead being coupled to a respective temperature sensor.

[0125] 14) A system according to 13), wherein the garment includes a sole area and the sensor arrangement is located between the sole area of ​​the garment and the covering.

[0126] 15) The system of 13) wherein the sensor leads are arranged as a flat harness passing through the garment.

[0127] 16) The system of 15) wherein the harness is shaped to follow a curved path.

[0128] 17) The system according to 15), wherein at least one sensor lead includes a distal portion branching from the wiring harness and its corresponding temperature sensor.

[0129] 18) The system according to 15), wherein at least a portion of the wiring harness is sealed within a polymer film.

[0130] 19) A system according to 12), wherein the sole area of ​​the garment includes a recessed portion for receiving at least a portion of the sensor arrangement.

[0131] 20) A system according to 12), wherein the sensor arrangement includes at least one temperature sensor arranged at a position on the sole area of ​​the garment, the position being selected from the group consisting of a phalangeal area of ​​the garment, between a phalangeal area and a metatarsal area of ​​the garment, between the metatarsal area of ​​the garment and a tarsal area of ​​the garment, and a heel area of ​​the garment.

[0132] 21) The system of 12) wherein the covering is coupled to a sole area around a perimeter of at least a portion of the sensor arrangement.

[0133] 22) The system of 12) wherein the covering comprises fabric.

[0134] 23) The system of 12) wherein the cover is heat sealed to the garment.

[0135] 24) The system of 12), wherein the garment further comprises a shell, wherein the shell surrounds a proximal portion of the sensor arrangement.

[0136] 25) The system of 24), wherein the housing further encloses at least one of a controller, a wireless communication module, a power source, and a memory.

[0137] 26) The system according to 12), wherein the garment is a pair of socks.

[0138] 27) A method for manufacturing a user monitoring system, the method comprising:

[0139] forming a sensor arrangement comprising at least one sensor lead, wherein the sensor lead is coupled to a sensor for measuring at least one parameter associated with a body part of a user;

[0140] positioning at least a portion of the sensor arrangement on a garment configured to be placed proximate the body part of the user; and

[0141] At least the portion of the sensor arrangement is enclosed between the garment and the covering.

[0142] 28) The method according to 27), wherein the at least one parameter is temperature.

[0143] 29) A method according to 27), wherein the at least one parameter is pressure.

[0144] 30) The method according to 27), wherein the at least one parameter is humidity.

[0145] 31) A method according to 27), wherein the at least one parameter is strain.

[0146] 32) The method according to 27), wherein the at least one parameter is user activity.

[0147] 33) A method according to 27), wherein enclosing at least the portion of the sensor arrangement comprises coupling the covering to the garment.

[0148] 34) The method of claim 33), wherein coupling the covering to the garment comprises coupling the covering to a sole area of ​​the garment around a perimeter of at least a portion of the sensor arrangement.

[0149] 35) The method of claim 27) wherein forming the sensor arrangement comprises arranging a plurality of sensor leads into a flat harness.

[0150] 36) A method according to 35) wherein the wiring harness is shaped to follow a curved path.

[0151] 37) The method according to 27), wherein the garment is socks.

[0152] 38) The method according to 27), wherein the garment is an insole.

[0153] 39) A system for monitoring a user, the system comprising:

[0154] a garment configured to be placed adjacent a body part of the user;

[0155] a cover coupled to the garment; and

[0156] A sensor arrangement is provided between the garment and the covering, wherein the sensor arrangement comprises at least one sensor to measure at least one parameter associated with the body part of the user.

[0157] 40) A system according to 39), wherein at least one of the sensors measures temperature.

[0158] 41) A system according to 39), wherein at least one of the sensors measures pressure.

[0159] 42) A system according to 39), wherein at least one sensor measures humidity.

[0160] 43) A system according to 39), wherein at least one of the sensors measures strain.

[0161] 44) The system of claim 39), wherein the at least one sensor measures user activity.

[0162] 45) The system of claim 39), wherein the sensor arrangement comprises a plurality of sensor leads, each sensor lead being coupled to a respective sensor.

[0163] 46) A system according to 45), wherein the sensor leads are arranged as a flat harness along the garment.

[0164] 47) A system according to 46) wherein the wiring harness is shaped to follow a curved path.

[0165] 48) A system according to 45), wherein the garment includes a sole area and the sensor arrangement is located between the sole area of ​​the garment and the covering.

[0166] 49) A system according to 48), wherein the sensor arrangement includes at least one sensor arranged at a position on the sole area, the position being selected from the group consisting of a phalangeal area of ​​the garment, between a phalangeal area and a metatarsal area of ​​the garment, between the metatarsal area of ​​the garment and a tarsal area of ​​the garment, and a heel area of ​​the garment.

[0167] 50) A system according to 48), wherein the covering is coupled to the sole area around a perimeter of at least a portion of the sensor arrangement.

[0168] 51) The system of claim 39) wherein the cover is heat sealed to the garment.

[0169] 52) A system according to 46), wherein at least a portion of the wiring harness is sealed within a flexible membrane.

[0170] 53) A system according to 39), wherein the garment is a sock.

[0171] 54) A system according to 39), wherein the garment is an insole.

Claims

1. A method for manufacturing a user monitoring system, the method comprising: forming a sensor arrangement comprising at least one sensor lead, wherein the sensor lead is coupled to a temperature sensor; positioning the sensor arrangement on a garment configured to be placed on a user's foot; coupling a housing to the garment, wherein the housing encloses at least one electrical component; and A cover is sealed to the garment around a perimeter of the sensor arrangement and the housing to enclose the sensor arrangement and the housing between the garment and the cover.

2. The method of claim 1 further comprising removing material from a sole area of ​​the garment to form a recessed portion of the sole area, wherein: Positioning at least a portion of the sensor arrangement includes positioning the sensor arrangement in the recessed portion of the sole region.

3. The method according to claim 1, wherein: Forming the sensor arrangement includes arranging the sensor leads into a flat wire bundle.

4. The method according to claim 3, wherein: The flat harness is shaped to follow a curved path.

5. The method according to claim 3, wherein: The sensor arrangement includes a plurality of sensor leads, and forming the sensor arrangement includes arranging at least one sensor lead such that a distal portion thereof and its corresponding temperature sensor diverge from the flat wire bundle.

6. The method of claim 1, further comprising sealing the sensor arrangement within a polymer film prior to enclosing the sensor arrangement and the housing between the garment and the covering.

7. The method according to claim 1, wherein: Sealing the covering to the garment around a perimeter of the sensor arrangement and the housing includes sealing the covering to a plantar region of the garment around a perimeter of at least a portion of the sensor arrangement.

8. The method according to claim 1, wherein: Sealing the cover to the garment includes heat sealing.

9. The method of claim 1, further comprising enclosing a proximal portion of the sensor arrangement in the housing.

10. The method according to claim 1, wherein: The garment is socks.

11. A system for monitoring a user, the system comprising: a garment configured to be placed on a foot of the user; a cover coupled to the garment; a sensor arrangement between the garment and the covering, wherein the sensor arrangement comprises at least one temperature sensor to measure at least one temperature on a foot of the user; and a housing between the garment and the covering, wherein the housing encloses at least one electrical component, wherein the cover is sealed to the garment around the sensor arrangement and a perimeter of the housing.

12. The system according to claim 11, wherein: The sensor arrangement includes a plurality of sensor leads, each sensor lead being coupled to a respective temperature sensor.

13. The system according to claim 12, wherein: The garment includes a plantar region, and the sensor arrangement is located between the plantar region of the garment and the covering.

14. The system according to claim 12, wherein: The sensor leads are arranged as a flat harness that passes through the garment.

15. The system of claim 14, wherein: The flat harness is shaped to follow a curved path.

16. The system of claim 14, wherein: At least one sensor lead includes a distal portion branching from the flat wire bundle and its corresponding temperature sensor.

17. The system of claim 14, wherein: At least a portion of the flat harness is sealed within a polymer film.

18. The system of claim 11, wherein: The sole area of ​​the garment includes a recessed portion for receiving at least a portion of the sensor arrangement.

19. The system of claim 11, wherein: The sensor arrangement includes at least one temperature sensor arranged at a location on the sole area of ​​the garment, the location being selected from the group consisting of a phalangeal area of ​​the garment, between a phalangeal area and a metatarsal area of ​​the garment, between the metatarsal area of ​​the garment and a tarsal area of ​​the garment, and a heel area of ​​the garment.

20. The system of claim 11, wherein: The cover is sealed to the plantar area around a perimeter of at least a portion of the sensor arrangement.

21. The system of claim 11, wherein: The covering comprises fabric.

22. The system of claim 11, wherein: The cover is heat sealed to the garment.

23. The system of claim 11, wherein: The housing surrounds a proximal portion of the sensor arrangement.

24. The system of claim 23, wherein: The housing also encloses at least one of a controller, a wireless communication module, a power source, and a memory.

25. The system of claim 11, wherein: The garment is socks.

26. A method for manufacturing a user monitoring system, the method comprising: forming a sensor arrangement comprising at least one sensor lead, wherein the sensor lead is coupled to a sensor for measuring at least one parameter associated with a body part of a user; positioning the sensor arrangement on a garment configured to be placed proximate the body part of the user; coupling a housing to the garment, wherein the housing encloses at least one electrical component; and A cover is sealed to the garment around a perimeter of the sensor arrangement and the housing to enclose the sensor arrangement and the housing between the garment and the cover.

27. The method according to claim 26, wherein: The at least one parameter is temperature.

28. The method according to claim 26, wherein: The at least one parameter is pressure.

29. The method according to claim 26, wherein: The at least one parameter is humidity.

30. The method of claim 26, wherein: The at least one parameter is strain.

31. The method of claim 26, wherein: The at least one parameter is user activity.

32. The method of claim 26, wherein: Sealing the covering to the garment includes sealing the covering to a plantar region of the garment around a perimeter of at least a portion of the sensor arrangement.

33. The method of claim 26, wherein: Forming the sensor arrangement includes arranging the plurality of sensor leads into a flat harness.

34. The method of claim 33, wherein: The flat harness is shaped to follow a curved path.

35. The method of claim 26, wherein: The garment is socks.

36. The method of claim 26, wherein: The garment is an insole.

37. A system for monitoring a user, the system comprising: a garment configured to be placed adjacent a body part of the user; a cover coupled to the garment; a sensor arrangement between the garment and the covering, wherein the sensor arrangement comprises at least one sensor to measure at least one parameter associated with the body part of the user; and a housing between the garment and the covering, wherein the housing encloses at least one electrical component, wherein the cover is sealed to the garment around the sensor arrangement and a perimeter of the housing.

38. The system of claim 37, wherein: The at least one sensor measures temperature.

39. The system of claim 37, wherein: The at least one sensor measures pressure.

40. The system of claim 37, wherein: The at least one sensor measures humidity.

41. The system of claim 37, wherein: The at least one sensor measures strain.

42. The system of claim 37, wherein: The at least one sensor measures user activity.

43. The system of claim 37, wherein: The sensor arrangement includes a plurality of sensor leads, each sensor lead being coupled to a respective sensor.

44. The system of claim 43, wherein: The sensor leads are arranged in a flat harness along the garment.

45. The system of claim 44, wherein: The flat harness is shaped to follow a curved path.

46. ​​The system of claim 43, wherein: The garment includes a plantar region, and the sensor arrangement is located between the plantar region of the garment and the covering.

47. The system of claim 46, wherein: The sensor arrangement includes at least one sensor arranged at a location on the sole area, the location being selected from the group consisting of a phalangeal area of ​​the garment, between a phalangeal area and a metatarsal area of ​​the garment, between the metatarsal area of ​​the garment and a tarsal area of ​​the garment, and a heel area of ​​the garment.

48. The system of claim 47, wherein: The cover is sealed to the sole area around a perimeter of at least a portion of the sensor arrangement.

49. The system of claim 37, wherein: The cover is heat sealed to the garment.

50. The system of claim 44, wherein: At least a portion of the flat harness is sealed within a flexible film.

51. The system of claim 37, wherein: The garment is socks.

52. The system of claim 37, wherein: The garment is an insole.

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