Device housing and mounting parts in user activity monitoring system

Abstract

An activity monitoring device for positioning on a user's body or on an orthopedic device is provided. The device has a housing enclosing a circuit board assembly having a sensor for monitoring movement of the circuit board assembly. The housing may be secured to the user's body or the orthopedic device with a dressing. The dressing may include a film layer to which the housing is adhered by an adhesive. The dressing may include a contact layer configured to be attached to a user or to an orthopedic device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to UK provisional application numbers 1809756.8, 1813969.1 and 1902774.7 filed on June 14, 2018, August 28, 2018 and March 1, 2019, the disclosures of which are incorporated herein by reference in their entirety. background Technical Field

[0004] Embodiments of the present disclosure relate to devices, systems, and methods for monitoring body load and body position to treat pressure ulcers. Background Art

[0006] Pressure ulcers, also known as pressure sores, bedsores, or decubitus ulcers, are injuries to the skin and underlying tissues caused by pressure on the skin, soft tissue, muscle, or bone that exceeds the capillary fill pressure (approximately 32 mmHg) for a prolonged period of time. Pressure ulcers may commonly form on the skin overlying bony areas (e.g., heels, ankles, buttocks, shoulder blades, spine, elbows, back of the head, and coccyx). People with limited mobility due to age or medical conditions are at increased risk for pressure ulcers because they are unable to change position when sitting or lying down. Management and treatment of pressure ulcers include repositioning the injured limb or body part and using support surfaces such as mattresses, cushions, etc.

[0007] One type of pressure ulcer that forms on the foot is called a diabetic foot ulcer (DFU), which tends to occur with greater frequency and intensity in the diabetic population. Management and treatment of diabetic foot ulcers requires offloading the wound through the use of cushioning footwear (e.g., supportive boots, casts, shoes, etc.). Although offloading can be effective, patient noncompliance with offloading devices has been found to play a significant role in delayed healing of diabetic foot ulcers because many offloading devices are removable.

[0008] However, prior art methods and systems provide little or no information about the patient's lifestyle and non-compliance or compliance with load-reducing devices and support surfaces. A deep understanding of the patient's lifestyle is crucial for preventing and healing pressure ulcers. However, due to these limitations, the prevention and healing of pressure ulcers in patients using prior art methods and systems may be delayed, or worse, the condition may worsen, leading to prolonged discomfort, hospitalization, or even surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Embodiments of the present disclosure will now be described hereinafter, by way of example only, with reference to the accompanying drawings, in which:

[0010] Figure 1 A user activity monitoring system including an exemplary activity monitoring device is shown;

[0011] Figure 2 Shows Figure 1 Exemplary components of an activity monitoring device and a data processing device;

[0012] Figure 3A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0013] Figure 3B Shows Figure 3A activity monitoring devices;

[0014] Figure 4A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0015] Figure 4B Shows Figure 4A activity monitoring devices;

[0016] Figure 5A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0017] Figure 5B Shows Figure 5A activity monitoring devices;

[0018] Fig. 6A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0019] Figure 6B Shows Fig. 6A activity monitoring devices;

[0020] Fig. 7A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0021] Figure 7B Shows Fig. 7A activity monitoring devices;

[0022] Fig. 8A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0023] Figure 8B Shows Fig. 8A activity monitoring devices;

[0024] Fig. 9A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0025] Fig. 9B Shows Fig. 9A activity monitoring devices;

[0026] Fig. 10A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0027] Fig. 10B Shows Fig. 10A activity monitoring devices;

[0028] Fig.11A Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0029] Fig. 11B Shows Fig.11A activity monitoring devices;

[0030] Fig.12 Shows Figure 1 Embodiments of a housing for an activity monitoring device;

[0031] Fig.13 Shows Figure 1 A side cross-sectional view of an embodiment of a housing for an activity monitoring device;

[0032] Fig.14 Shows Figure 1 A perspective view of an inner surface of an embodiment of a cover portion of a housing of an activity monitoring device;

[0033] Fig.15A Shows Fig.14 inner surfaces of a cover portion and a base portion of the housing;

[0034] Fig. 15B Shows Fig.14 inner surfaces of a cover portion and a base portion of the housing;

[0035] Fig. 15C Shows Fig.14 An assembled shell;

[0036] Fig.15D Shows Fig.14 An assembled shell;

[0037] Fig.16 Shown is located Figure 1 a printed circuit board assembly (PCBA) in a cover portion of a housing of an activity monitoring device;

[0038] Fig.17A and 17B An exemplary dressing is shown. Figure 1 An embodiment of an activity monitoring device;

[0039] Fig.18 An embodiment of a power source and associated mounting is shown;

[0040] Fig.19A Shows Figure 1 An embodiment of a cover portion of a housing of an activity monitoring device together with a PCBA;

[0041] Fig.19B Shows Fig.19A The PCBA is aligned to be placed on Fig.19A in a cover portion of a housing of an activity monitoring device;

[0042] Fig.19C Shows Fig.19A The PCBA is located at Fig.19A The cover portion of the housing of the activity monitoring device, wherein Fig.18 The power supply and associated installation parts are connected together;

[0043] Fig. 20A and 20B They are shown respectively Figure 1 side and top views of an embodiment of a base portion of a housing of an activity monitoring device including an exemplary adhesive applied;

[0044] Fig.21 An embodiment of an exemplary packaging material is shown, the packaging material being positioned to surround Figure 1 a housing for an activity monitoring device;

[0045] Fig.22A Shown is applied to Figure 1 Embodiments of an adhesive on a base portion of a housing of an activity monitoring device;

[0046] Fig. 22B Shown is a schematic diagram of an exemplary dressing. Fig.22A Embodiments of a housing for an activity monitoring device;

[0047] Fig. 22C Shows Fig.22A Positioning of the housing of the activity monitoring device and the dressing on the curing frame;

[0048] Fig.23A Shown is a schematic diagram of an exemplary dressing. Figure 1 a top view of a housing of an activity monitoring device;

[0049] Fig. 23B shows a device having components spaced apart from each other Fig.23A A side view of a housing and a dressing of an activity monitoring device;

[0050] Fig.23CAn exemplary dressing and unassembled components are shown. Figure 1 An embodiment of an activity monitoring device;

[0051] Fig.24A Shows Figure 1 Embodiment of a cover portion of a housing of an activity monitoring device;

[0052] Fig. 24B and 24C Shows Figure 1 side and perspective views of an embodiment of a base portion of a housing of an activity monitoring device;

[0053] Fig.25A An exemplary dressing and unassembled components are shown. Figure 1 An embodiment of an activity monitoring device;

[0054] Fig.25B Shows Fig.25A A side view of a housing and a dressing of an activity monitoring device;

[0055] Fig.25C Shows Fig.25A A top view of a housing and a dressing of an activity monitoring device;

[0056] Fig.26A An exemplary dressing and unassembled components are shown. Figure 1 An embodiment of an activity monitoring device;

[0057] Fig.26B Shows Fig.26A A side view of a housing and a dressing of an activity monitoring device;

[0058] Fig.26C Shows Fig.26A A top view of a housing and a dressing of an activity monitoring device;

[0059] Fig.27A Shows Figure 1 A side view of an embodiment of an activity monitoring device, wherein components of the activity monitoring device are spaced apart from one another;

[0060] Fig.27B Shows Fig.27A A top view of a housing and a dressing of an activity monitoring device;

[0061] Fig.28A Shows Figure 1 A side view of an embodiment of an activity monitoring device, wherein components of the activity monitoring device are spaced apart from one another;

[0062] Fig.28B Shows Fig.28A An embodiment of a top view of a housing and a dressing of an activity monitoring device;

[0063] Fig.28C Shows Fig.28A An alternative embodiment of a top view of a housing and a dressing of an activity monitoring device;

[0064] Fig.29A Shows Figure 1 A side view of an embodiment of an activity monitoring device of the device, wherein components of the activity monitoring device are spaced apart from one another;

[0065] Fig.29B Shows Fig.29A A top view of a housing and a dressing of an activity monitoring device;

[0066] Fig. 30A Shows Figure 1 A side view of an embodiment of an activity monitoring device of the device, wherein components of the activity monitoring device are spaced apart from one another;

[0067] Fig. 30B Shows Fig. 30A A top view of a housing and a dressing of an activity monitoring device;

[0068] Fig.31A Shows Figure 1 A side view of an embodiment of an activity monitoring device of the device, wherein components of the activity monitoring device are spaced apart from one another;

[0069] Fig.31B Shows Fig.31A A top view of a housing and a dressing of an activity monitoring device;

[0070] Fig.32A Shows Figure 1 A side view of an embodiment of an activity monitoring device of the device, wherein components of the activity monitoring device are spaced apart from one another;

[0071] Fig.32B Shows Fig.32A A top view of a housing and a dressing of an activity monitoring device;

[0072] Fig.33A Shows Figure 1 A side view of an embodiment of an activity monitoring device of the device, wherein components of the activity monitoring device are spaced apart from one another;

[0073] Fig.33B Shows Fig.33A A top view of a housing and a dressing of an activity monitoring device;

[0074] Fig.34 showing a side view of an embodiment of an activity monitoring device having a housing attached to a dressing; and

[0075] Fig.35 A side view of an embodiment of an activity monitoring device with a housing attached to a dressing is shown.

[0076] Fig.36 An exploded view of an embodiment of a dressing to which an activity monitoring device may be attached is shown. DETAILED DESCRIPTION

[0077] Overview

[0078] Activity monitoring device can be a wearable component that can be used to monitor diabetic foot ulcers.Activity monitoring device can include sensor or many sensors, including accelerometer (such as, 3-axis accelerometer), gyroscope, magnetometer, air pressure (barometer), light (for example, can be used to identify day / night cycle, initial operation such as removal from opaque packaging or opaque release handle / label, adhesion failure such as when sensor points to tissue and lights up when activity monitoring device falls, or data transmission), or temperature.One or more sensors can be mounted on a single or multilayer board (for example, FR4 board) or other substrate (for example, polyimide).Sensors of various types (or elements in sensors) can be combined to be used as inertial measurement units (INU) (for example, 2 sensors use 6 axes or 3 sensors use 9 axes), even if one sensor (for example, accelerometer) may only be actively read (for example, powered on) at some or all times.In some embodiments, accelerometer, gyroscope and magnetometer can be initially used as 9-axis INU to identify reference position and angle, and then one or more elements or components (such as power consumption components) are turned off at some or all times.

[0079] The activity monitoring device can be worn just below the knee and can be toward the inside of the knee. The activity monitoring device can be packaged or otherwise enclosed in a housing. The activity monitoring device can be attached using an adhesive, a film adhesive, or via clothing. The activity monitoring device or one or more sensors with the activity monitoring device can include a portable energy source, such as a battery. In some embodiments, sensors that are not needed can be conveniently removed to utilize the limited energy budget available, or to minimize the risk of noise from external sources of the signal and software.

[0080] The activity monitoring devices can be applied to different surfaces for monitoring different surfaces, and thus separate activity monitoring devices can be used to monitor different parts of a user's activity monitoring system. For example, one activity monitoring device can monitor a patient while another activity monitoring device can monitor a load-reducing device (e.g., a load-reducing boot, insole, crutch, or other mobility aid) such as may be used by a patient with a foot ulcer (e.g., a diabetic foot ulcer).

[0081] The housing of the activity monitoring device may have one or more of the following features. The housing may have a thinned area to allow the user to press the button in the housing while providing protection to avoid accidental operation of the button. The area may be in the form of a triangular cutout and formed in the top portion of the housing to avoid a single button. The other parts of the housing may be designed to be harder than this button area. The shape and size of the area may be set to accommodate the thumb pad. A wide range of button designs may be used. The thinned area may also allow the light source to shine through, and the light level of the shining through may be adjusted by selecting the thickness of the housing or by selecting the transparency and color of the housing. This may allow the circuit board to be positioned or supported inside the housing. For example, a circumferential constraint or 4 nails spaced at 90 degrees may fix the rotation and lateral alignment of the circuit board relative to the housing, while the ledge fixes the height of the circuit board relative to the top surface. For example, this may facilitate the circuit board to be in the correct orientation and at the correct height to provide interaction with the button, and also align the light source in the thinned area. Within the top molding, portions of the cover may be intentionally stiffened by using a thicker material thickness, and these thicker areas may be cored to ensure that the portion is moldable, avoid sinking, and maintain stiffness in these areas while reducing overall weight. The bottom molding may have a generally flat surface with a small radius of curvature on the outside to allow the portion to be attached to the human body while avoiding clothing getting caught under the edges and tearing the portion. Additionally, the bottom surface may have a small recess to allow attachment of double-sided adhesive tape to attach the tracker to the person. The top molding may be shaped in a rounded and smooth manner to avoid any points where the activity monitoring device may get caught on clothing or other objects, and may also allow the activity monitoring device to have a smaller visual footprint. The housing may be made of a photopolymer 3D printing material with a Shore hardness of 73–77 on the A scale by stereolithography (SLA) or multi-jet, or may be made of an engineering resin with a Shore hardness of 80A by 3D printing. The housing may include an elastomer, a thermoplastic elastomer, or be constructed by injection molding. The molded portion may be made of liquid silicone rubber in white. The two molded pieces may be glued together using an adhesive (e.g., adhesives used to attach plastics and elastomeric materials), and a wide range of other adhesives (e.g., cyanoacrylates, silicones, epoxies, hydrogels, hydrocolloids, sealant systems) or other techniques (e.g., using double-sided adhesive tape, ultrasonic welding, riveting, etc.) may be used. The top and bottom shells may be designed to have a small gap between them in the assembled state to allow for adhesive thickness, but also to allow the circuit board to be slightly clamped in the assembled shell (to prevent the circuit board from "wobbling" within the shell and accidentally pressing buttons). The purpose may be to apply very little pressure between the top and bottom shells while the adhesive is curing. When assembled, the features of the top and bottom shells may form a wrap-around path to assist in ingress protection.Features in the side walls of the two moldings may allow the parts to be held together mechanically or grooves for adhesive. Pressure or light sensors or other components may be removed from the activity monitoring device to reduce power consumption.

[0082] The housing can be sealed, flexible, and have a known Shore hardness. The housing can have mechanical structures and design features that provide shoulder key slot alignment of the elements of the activity monitoring device. The housing can include an area designed to support a circuit board. The housing can have a flexible surface above the circuit board, and a pin designed to provide force to a button above the board. The housing can include a thin area for observing a light emitting diode (LED) encapsulated in the housing. The housing can include a housing member that contacts a component (e.g., a printed circuit board assembly) of the activity monitoring device. Portions of the housing can be made transparent to visible light or ultraviolet (UV) light, and enhance the visibility of the LED encapsulated in the housing member of the activity monitoring device when the LED is activated. The housing member or housing can have a hard base and a soft top, or a soft base and a hard top. The housing can be suitable for sealing both sides of the housing with an adhesive material. The housing can be sealed or configured so that when (e.g., by separating the two parts of the housing) the housing is unsealed or deconstructed or the housing is tampered with, one or more components located in the housing are destroyed or stop working normally. For example, one component in the housing (e.g., a circuit board or a component attached to a circuit board) may be attached to a first portion of the housing, and another component in the housing may be attached to a second portion of the housing, so that when the first and second portions are separated, the one component may be separated from the other component, thereby (e.g., by disconnecting the electrical connection between one component and the other component, or by disconnecting the electrical connection on one component or the other component to disconnect the function) stopping the one component and the other component from operating normally. The housing may be adhered to the patient of the orthopedic device by using an adhesive film. Alternatively, the housing may be bonded to the adhesive film using a glue such as a super glue for tissue. The adhesive film may be an IV3000 dressing (e.g., an Opsite Flexigrid dressing), or any other adhesive film dressing that has been used for wound care. The adhesive may be an adhesive of a medical or healthcare grade. Alternatively, the adhesive may be any adhesive film that is tolerable to human skin. The adhesive on the film may be an acrylic or silicone gel.

[0083] The activity monitoring device can be adhered, sewn, placed (or the like) in a garment, such as a knee brace, a knee brace, a garter, or a close-fitting fabric tube worn on a portion of a limb. The activity monitoring device can be held in place by inserting the device into a pocket at the knee, a pocket of certain suitable clothing (including pants, knee braces, etc.). The activity monitoring device can be secured to the user or orthopedic device using a strap (e.g., similar to a watch strap or belt that can be used) or using a clip (e.g., similar to a money clip).

[0084] The activity monitoring device may be retained in a shoelace or other article of clothing. The activity monitoring device may be integrated into a shoe. The activity monitoring device may be given a color that promotes flexibility or integration of the activity monitoring device, for example by matching the color of the device to skin color. The activity monitoring device may be given a color to make the product eye-catching in an emergency. The form factor of the activity monitoring device may be adapted so that the activity monitoring device can be worn and can protrude from the skin. Thus, the activity monitoring device may be given a shape that avoids shapes that may snag on clothing. The activity monitoring device may have a low profile. For example, the sides of the activity monitoring device may be arranged so that they have no obvious protruding parts. The sides of the activity monitoring device may be contoured, for example, into a dome or a truncated cone. The activity monitoring device may be designed to allow a low profile design, rather than a stacked design.

[0085] Chemical agents may be included in the shell material to help reduce friction across the shell surface. For example, EPDM (ethylene-propylene diene monomer rubber) may be attached to the leg or to a load-reducing device. The activity monitoring device may be attached to an item such as a boot, a cane, or a carrier. The activity monitoring device may be attached to a mobility aid. The activity monitoring device may be attached to a tubular object. The activity monitoring device may be attached to a carrier with a hook-and-loop fastening strap. The activity monitoring device may be attached using a cable tie or other fastener that does not require any tools to secure the activity monitoring device with the fastener. The activity monitoring device may be attached by screws. The activity monitoring device may be attached to an orthopedic device, such as an external fixator (e.g., an Ilizarov device). The activity monitoring device may be applied to a dressing, such as a wound dressing.

[0086] To move from a disposable activity monitoring device to a non-disposable activity monitoring device, there may be no adhesive film on the underside of the housing. Non-circumferential adhesive dressings typically have a limited wear time due to the shedding of epithelial cells of the skin. In contrast, in some embodiments, the activity monitoring device may use a dressing fixed to its periphery, which may allow the dressing to be removed and reapplied using the same sensor and housing. For example, the activity monitoring device may be attached using an adhesive film dressing with a hole cut into it that is slightly smaller than the size of the housing. Any suitable profile that is circular or corresponds to a reduced version of the profile of the housing may be used. The membrane may be tented to hold the edges of the housing, alternatively the membrane may be cut to form a leaf shape, etc.

[0087] Introduction to Wound Monitoring and Treatment

[0088] For various reasons, including wound prevention and monitoring, it is desirable to monitor a user's activity by an activity monitoring device. In one example, a user's activity may be monitored when the user may be susceptible to or has developed a pressure ulcer. Information about the user's activity collected by the activity monitoring device may be useful in helping prevent or treat the pressure ulcer. Additionally, information about activity collected by the activity monitoring device may be used to check compliance with a treatment regimen.

[0089] Embodiments disclosed herein relate at least to devices, systems, and methods for monitoring body load and body position to treat pressure ulcers. Load may refer to transferring or applying at least a threshold amount of force on a body part. Such a threshold amount of force is applied to a body part so that the body part supports weight. For example, the load on a foot may refer to transferring or applying at least a portion of the body weight (or the body weight combined with an external weight) on the foot so that the foot supports at least this portion of the body weight. At least this portion of the body weight can be used as a threshold to determine that the foot has been loaded.

[0090] Some embodiments relate to monitoring or treating wounds on the human or animal body. Thus, any reference herein to a wound may refer to a wound on the human or animal body, and any reference herein to a body may refer to the human or animal body. Embodiments of the disclosed technology may relate to preventing or minimizing damage to physiological or living tissue, or to treating damaged tissue (e.g., a wound as described herein).

[0091] As used herein, the expression "wound" may include damage to living tissue that may be caused by cutting, blows or other impacts, usually skin being cut or broken. Wounds may be chronic or acute injuries. Acute wounds occur due to surgery or trauma. They undergo various healing stages within a predicted time frame. Chronic wounds usually begin as acute wounds. When acute wounds do not follow the healing stages, acute wounds may become chronic wounds, thereby prolonging recovery time. The transition from acute wounds to chronic wounds is believed to be caused by impaired immunity of the patient.

[0092] Chronic wounds may include, for example: venous ulcers (such as those arising in the legs), which account for the majority of chronic wounds and primarily affect the elderly; diabetic ulcers (e.g., foot or ankle ulcers); peripheral arterial disease; pressure sores or epidermolysis bullosa (EB).

[0093] Examples of other wounds include, but are not limited to, abdominal wounds or other large or open wounds resulting from surgery, trauma, sternotomy, fasciotomy, or other conditions, open wounds, acute wounds, chronic wounds, subacute and open wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure sores, ostomies, surgical wounds, traumatic ulcers, and venous ulcers, among others.

[0094] Wounds can also include deep tissue injury. Deep tissue injury is a term proposed by the National Pressure Ulcer Advisory Panel (NPUAP) to describe a unique form of pressure sores. For many years clinicians have described these sores using terms such as purple pressure sores, ulcers that may ulcerate and bruise over bony prominences.

[0095] Wounds may also include tissue that is at risk of becoming a wound as discussed herein. For example, tissue at risk may include tissue on a bony prominence (at risk of deep tissue injury / damage) or pre-operative tissue (e.g., knee tissue) that may be cut (e.g., for joint replacement / surgical alteration / reconstruction).

[0096] Some embodiments relate to methods of monitoring or treating wounds using the technology disclosed herein in combination with one or more of the following: advanced footwear, turning the patient, offloading (e.g., offloading a diabetic foot ulcer), treatment of infection, system integration, antimicrobial, antibiotics, surgery, removal of tissue, affecting blood flow, physiotherapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, active ozone, antibiotics, antimicrobial agents, etc.

[0097] Wounds may be treated using topical pressure (eg, using negative or positive pressure therapy) or traditional advanced wound care that is not aided by the use of applied pressure (also referred to as non-pressure therapy).

[0098] The use of an orthotic device that takes weight off a body part (e.g., a contact cast or walking boot) may be important to healing or preventing an injury to a body part, such as a pressure ulcer. An orthotic device may be provided to a patient by a caregiver with specific instructions to use the orthotic device in a manner that will heal or prevent an injury.

[0099] User activity monitoring system

[0100] Figure 1 A user activity monitoring system 100 is shown that includes an activity monitoring device 20 attached to a body part 10. The activity monitoring device 20 may be attached to the body part 10 using a strap, adhesive, or other coupling mechanism, and may be worn on or supported by the body.

[0101] Body part 10 may be a user's leg, including knee 12 and foot 14. As shown, in some embodiments, activity monitoring device 20 may be supported by body part 10 at a position between knee 12 and foot 14 (e.g., near foot 14). In other embodiments, activity monitoring device 20 may be supported by another portion of body part 12. Activity monitoring device 20 may monitor and record the activity of body part 10 (e.g., walking, jumping, sitting, lying down, running, squatting, or standing), such as the position, movement, or orientation of one or more other sensors of activity monitoring device 20 or activity monitoring device 20. Activity monitoring device 20 may, for example, be used to load monitor the load of foot 14. In some embodiments, multiple body parts may be monitored by activity monitoring device 20, and different sensors may be used to monitor different body parts.

[0102] Body part 10 is shown wearing and partially covered by an orthotic device 30. The orthotic device 30 may support the body part 10 and reduce pressure on the foot 14 when the user may be standing or engaging in other activities. A compliance monitoring device 32 may be attached to the orthotic device 30. The compliance monitoring device 32 may be the same as or different from the activity monitoring device 20 and be supported by the orthotic device 30 using a strap, adhesive, or other attachment mechanism. The compliance monitoring device 32 may be attached to an inner surface of the orthotic device 30 such that the compliance monitoring device 32 is disposed between the orthotic device 30 and the patient's skin. The compliance monitoring device 32 may be attached to an outer surface of the orthotic device 30 such that a portion of the orthotic device 30 is disposed between the compliance monitoring device 32 and the patient's skin. Although Figure 1 Not shown, but the compliance monitoring device 32 may be attached to an orthopedic device 30 (eg, crutch, walker) that is not worn by the patient.

[0103] although Figure 1 10, but the user activity monitoring system 100 may additionally or alternatively include one or more of the activity monitoring device 20 or the compliance monitoring device 32 at other locations, such as at a location supported by the orthopedic device 30 or another portion of the body part 10. These one or more additional or alternative schemes of the activity monitoring device 20 or the compliance monitoring device 32 can be the same as or similar to the activity monitoring device 20 that can monitor and record the activity of the orthopedic device 30 or another portion of the body part 10.

[0104] Figure 2 Shown are components 200 of an activity monitoring device 20 and a data processing device 40. The activity monitoring device 20 may be located proximate to the data processing device 40 and communicate with the data processing device 40, such as wirelessly.

[0105] The activity monitoring device 20 and the data processing device 40 may together configure a communication channel with each other to allow the transmission of recorded activity or other data from the activity monitoring device 20 and the data processing device 40, or the transmission of one or more commands from the data processing device 40 to the activity monitoring device 20, among other possibilities. The data processing device 40 may be, for example, a smart phone or a tablet computer.

[0106] Activity monitoring device 20 may be at least partially or may be completely covered by a conductive material, a dielectric material, etc. (e.g., a polymer or an object that can approximate the conductance or capacitance of a human finger). Data processing device 40 may include a touch-sensitive display that detects conductive or dielectric materials on activity monitoring device 20 to determine contact between activity monitoring device 20 and a display of data processing device 40.

[0107] like Figure 2 As shown, the activity monitoring device 20 may include a controller 202, a memory device 204, a user interface 206, a power supply 208, one or more sensors 210, and a communication interface 212 configured to communicate electrically with each other. The power supply 208 may provide power to one or more components of the activity monitoring device 20. As discussed in more detail below, the components of the activity monitoring device 20 may be contained in or supported by a housing of the activity monitoring device 20. The data processing device 40 may include a controller 222, a memory device 224, a user interface 226, a power supply 228, one or more sensors 230, and a communication interface 232 configured to communicate electrically with each other. The power supply 228 may provide power to one or more components of the data processing device 40. The components of the data processing device 40 may be contained in or supported by a housing of the data processing device 40. In other embodiments, the activity monitoring device 20 and the data processing device 40 may include different Figure 2 Additional or alternative components as shown in .

[0108] Controller 202 may control the operation of one or more other components of activity monitoring device 20 based at least on instructions stored in memory device 204. Controller 202 may, for example, control monitoring of the load of body part 10 with the weight of the body or the positioning of body part 10, and record data indicating the load of body part 10 or the positioning of body part 10 to memory device 204.

[0109] User interface 206 may include one or more output elements, such as indicators (e.g., light emitting diodes) or speakers, that provide user output to the user. One or more output elements may convey status information to the user, such as whether activity monitoring device 20 is successfully operating or has been successfully configured to communicate with data processing device 40. User interface 206 may further include one or more input elements, such as buttons, switches, dials, or touch screens, for receiving user input to configure activity monitoring device 20. In some embodiments, user interface 206 may have no more than one user input element (e.g., a button) for receiving user input to enable and disable activity monitoring device 20 or to perform one or more other functions.

[0110] One or more sensors 210 may be used to detect and monitor the movement of activity monitoring device 20. One or more sensors 210 may be used to detect and monitor the activity of a user of activity monitoring device 20 (including, for example, the load or positioning of body part 10). One or more sensors 210 may include one or more accelerometers, gyroscopes, magnetometers, pressure sensors, impedance sensors, thermistors, or optical sensors, among other types of sensors. One or more sensors 210 may be located near body part 10, or may be located away from body part 10 but may be used to monitor characteristics of body part 10.

[0111] The communication interface 212 may be used, for example, to communicate via radio waves and in accordance with Bluetooth. TM Protocols (such as Bluetooth TM The communication interface 212 may communicate with the data processing apparatus 40 using a communication protocol such as a low energy or another protocol. The communication interface 212 may, for example, send device usage data such as alarms, monitored loads or locations, or changes to a monitoring or treatment program performed by the activity monitoring device 20 to the data processing apparatus 40. The communication interface 212 may be used to receive data including commands from the data processing apparatus 40.

[0112] Turning to the data processing device 40, the controller 222 of the data processing device 40 may control the operation of one or more other components of the data processing device 40 based at least on instructions stored in the memory device 224. The controller 222 may, for example, configure and control communications with the activity monitoring device 20, and process data received from the activity monitoring device 20, or send commands to the activity monitoring device 20. The data processing device 40 may execute one or more applications to facilitate communication with the activity monitoring device 20.

[0113] The user interface 226 of the data processing device 40 may include one or more elements that receive user input or provide user output to the user. The one or more elements of the user interface 226 that receive user input may include buttons, switches, dials, touch screens, etc., and the one or more elements that provide user output may include indicators, screens, speakers, etc.

[0114] One or more sensors 230 of data processing device 40 may be used to monitor the environment around data processing device 40. One or more sensors 230 may include one or more accelerometers, gyroscopes, magnetometers, pressure sensors, impedance sensors, thermistors, or optical sensors, among other types of sensors.

[0115] The communication interface 232 of the data processing device 40 can be used, for example, via radio waves and according to Bluetooth. TM Protocols (such as Bluetooth TM The communication interface 232 may communicate with the activity monitoring device 20 using a wireless low energy or another protocol. The communication interface 232 may, for example, receive device usage data such as alarms, monitored loads or locations, or changes to a monitoring or treatment program performed by the activity monitoring device 20, or send data such as commands.

[0116] Activity monitor housing

[0117] Figure 3A A housing 400A of an activity monitoring device 120A (which may be an example of an activity monitoring device 20) is shown. The housing 400A may be arranged to enclose a printed circuit board assembly (PCBA) 300. The housing 400A may have a cover portion 402A and a base portion 404A. The cover portion 402A and the base portion 404A may be coupled together to form an enclosed space within the housing 400A. The enclosed space may be sized to accommodate at least the PCBA 300. Figure 3A In the illustrated embodiment, the cover portion 402A has an inner edge 406A that is nested within an outer sidewall 408A disposed on the base portion 404A to form an enclosed space within the housing 400A. In some embodiments, the orientation of the inner edge 406A and the outer sidewall 408A can be reversed so that the inner edge 406A is disposed on the base portion 404A and the outer sidewall 408A is disposed on the cover portion 402A.

[0118] PCBA 300 may include one or more components of activity monitoring device 120A, such as controller 202, memory device 204, user interface 206, power supply 208, sensor 210, and communication interface 212. In some embodiments, one or more components of activity monitoring device 120A may be mounted to a portion of activity monitoring device 120A other than PCBA 300, such as housing 400A. Figure 3A As shown, PCBA 300 may include micro switch 302. PCBA 300 may include more than one micro switch 302. Micro switch 302 may include button 304. Micro switch 302 may be activated by applying a compressive force to button 304.

[0119] As discussed in more detail herein, housing 400A may be arranged such that targeted or intentional compression of housing 400A within a specific vicinity of microswitch 302 activates microswitch 302. Housing 400A may include features that cause button 304 to be depressed when targeted compression is applied to housing 400A in the vicinity of microswitch 302. Housing 400A may be arranged such that non-targeted or unintentional compression of housing 400A outside of a specific vicinity of microswitch 302 does not activate microswitch 302. Housing 400A may be arranged such that housing 400A protects PCBA 300 from compressive forces applied to housing 400A.

[0120] Figure 3B Shows Figure 3A An exploded view of the activity monitoring device 120A is shown. Figure 3B As shown, when the housing 400A is assembled, the cover portion 402A can have an outer surface 412A that faces away from the base portion 404A. The outer surface 412A of the cover portion 402A can have a recessed portion 414A and a raised portion 416A. In the illustrated embodiment, the raised portion 416A is disposed near the perimeter of the cover portion 402A. The recessed portion 414A of the depicted embodiment is substantially planar and extends from the raised portion 416A to a raised edge 418A disposed at the perimeter of the cover portion 402A. The depicted raised edge 418A and raised portion 416A extend away from the recessed portion 414A by substantially the same amount, such that the top surfaces of the raised portion 416A and the raised edge 418A are substantially coplanar with each other at the location where they meet. As discussed herein, the arrangement of the recessed and raised portions of the housing 400A can vary from one embodiment to another. Figure 3B The arrangement shown in .

[0121] Continue to refer Figure 3B, when the housing 400A is assembled, the cover portion 402A may have an inner surface 420A facing the base portion 404A. The inner surface 420A of the cover portion 402A may include one or more recessed portions 414A or raised portions 416A as previously described. In the illustrated embodiment, the inner surface 420A has a raised boss 422A extending from a recessed hole 424A that circumferentially surrounds the raised boss 422A.

[0122] Return to reference Figure 3A 4. As shown in a perspective view of the cover portion 402A in an assembled view of FIG. 4, the cover portion 402A may include a landing pad 426A (sometimes referred to as a raised pad) that is longitudinally aligned with a raised boss 422A disposed on the inner surface 420A of the cover portion 402A. The landing pad 426A may be adapted to guide a user's thumb into an appropriate position for activating the microswitch 302A. Figure 3A In the illustrated embodiment, the landing pad 426 is raised relative to the immediately adjacent portion of the outer surface 412A of the cover portion 402A. In some embodiments, the landing pad 426A may be recessed relative to the surrounding portion of the outer surface 412 of the cap 402 (e.g., see Fig.13 ). The housing 400A can be arranged so that when the activity monitoring device 120A is assembled, the raised boss 422A is longitudinally aligned above the top of the button 304 of the microswitch 302. The recessed hole 424A can reduce the support for the landing pad 426 so that the compressive force applied to the landing pad 426A causes the landing pad 426 to move toward the base portion 404A of the housing 400A. In the embodiment shown, the landing pad 426A is located near the periphery of the cover portion 402A. In some embodiments, the landing pad 426A can be centrally located on the cover portion 402A.

[0123] The housing 400A may be arranged such that a compressive force applied to the landing pad 426A activates the micro switch 302 when the compressive force is applied substantially parallel to the longitudinal axis 10 of the activity monitoring device 120A, and does not activate when the compressive force is applied substantially non-parallel to the longitudinal axis 10. For example, the raised edge 418A, the inner edge 406A, and the outer sidewall 408A may be arranged to form a support structure that distributes the compressive load away from the micro switch 302 when the compressive load is applied in areas of the housing 400A other than the landing pad 426A or in a direction other than substantially parallel to the longitudinal axis 10 of the housing 400A. The raised edge 418A, the inner edge 406A, and the outer sidewall 408A may form a thickened outer wall to resist overall compression of the activity monitoring device 120A. In some embodiments, raised edge 418A provides a rigid annular structure that transmits force to base portion 404A through engagement of inner edge 406A and outer sidewall 408A, thereby bypassing the transfer of compressive loads to button 304 of microswitch 302. In this way, housing 400A may be adapted to prevent microswitch 302 from being activated by someone or something leaning against activity monitoring device 120A.

[0124] The sensor 210 may have a default or desired orientation in which the sensor 210 operates. The operation of the sensor 210 in the default or desired orientation may desirably, for example, reduce the computational burden of processing data output by the sensor 210, because the data may be detected relative to the default orientation (e.g., relative to gravity). In order to facilitate the orientation and operation of the sensor 210 in the default or desired orientation, the sensor 210 may be positioned on the PCBA 300 in a specific orientation so that the sensor 210 may be positioned relative to the housing 400A in a certain orientation. The housing 400A may then be designed or indicated to be oriented on the user in a given orientation so that the sensor 210 may be oriented in the default or desired orientation during operation. In one example, when the cover portion 402A and the base portion 404A are coupled together and enclose the sensor 210, the orientation of the face of the landing pad 426A may be used to identify the default or desired orientation of the sensor 210. For example, the face of the landing pad 426A may be initially positioned on the user to align with the direction of gravity so that the sensor 210 is positioned in the default or desired orientation. Additionally or alternatively, when the sensor 210 may be enclosed in the housing 400A, a tag placed on the housing 400A may be used to determine a default or desired orientation of the sensor 210 .

[0125] Figures 4A to 11BVarious embodiments of the housing 400 are shown, the various embodiments having different configurations of the raised and recessed portions of the housing 400. The raised and recessed portions of the housing 400 can be arranged so that the micro switch 302 is protected from activation by non-targeted or accidental compression of the housing 400. For clarity, similar reference numerals are used in the present disclosure to represent similar features of various embodiments. Within the scope and spirit of the present disclosure, the features of the different embodiments disclosed herein can be combined or substituted with each other to form additional embodiments.

[0126] For example, Fig. 6A and 6B As shown in , the housing 400D may include one or more pillars 430. The pillars 430 may be arranged as thickened portions of the cover portion 402 or the base portion 404 of the housing 400D. The pillars 430 may be adapted to distribute or direct non-targeted compressive loads away from the microswitch 302 or one or more other components within the housing 400D. The housing 400D may include one or more pillars 430 disposed on an inner or outer surface of the cover portion 402 or the base portion 404 of the housing 400. In Fig. 6A and 6B In the illustrated embodiment, the housing 400D has three pillars 430 disposed on the inner surface 420 of the cover portion 402. The three pillars 430 radiate from the center point of the cover portion 402D and are substantially equally spaced from each other along the circumference. As shown in the embodiments disclosed herein, the housing 400D may include one or more pillars 300, the one or more pillars being connected to the inner surface 420 of the cover portion 402. Fig. 6A and 6B The equally spaced struts shown in FIG. 1 are arranged differently.

[0127] Fig.12 A housing 400J is shown having a cup-shaped cover portion 402J and a dish-shaped base portion 404J. The cover portion 402J may include a PCBA seat surface 432, such as Fig.12402J. The PCBA seat surface 432 may help position the PCBA 300 in the cover portion 402. When the activity monitoring device 120J is assembled, the PCBA seat surface 432 may help properly position the PCBA 300 relative to the housing 400J. In some embodiments, the PCBA seat surface 432 is configured so that when the PCBA 300 is seated in the cover portion 402J of the housing 400J, the boss 422 is aligned with the button 304 of the micro switch 302. In some embodiments, the PCBA seat surface 432 and the cover portion 402J are arranged so that when the PCBA 300 is seated on the PCBA seat surface 432 of the cover portion 402J, a light source (e.g., an LED; not shown) disposed on the PCBA 300 is aligned with the thinned area 434J of the cover portion 402J. The thinned area 434J may be adapted to allow the light source to be visible through the cover portion 402J when the light source is illuminated.

[0128] The cup-shaped portion 402J and the dish-shaped portion 404J of the housing may be oriented relative to Fig.12 Invert the construction in . For example, Fig.11A and 11B A housing 400I is shown having a cup-shaped base portion 404I and a disc-shaped cover portion 402I. In some embodiments, the PCBA 300 is seated in the cup-shaped portion of the housing 400I. In some embodiments, the PCBA 300 is seated on the disc-shaped portion of the housing 400I. In some arrangements, proper alignment of the PCBA 300 with the housing 400J is facilitated by arranging the housing 400J so that the PCBA 300 is seated on a seating surface 432 provided on the cup-shaped cover portion 402J. This arrangement facilitates precise assembly because the PCBA 300 can be aligned with the cover portion 402J to facilitate closure. Again, briefly referring to Fig.11A , placing PCBA 300 in cup-shaped base portion 404I may complicate proper alignment of PCBA 300 with cover portion 402I because PCBA 300 may be aligned first with base portion 404I and then with cover portion 402I, thereby increasing the possibility of error compared to fitting PCBA 300 into cup-shaped cover portion 402 (which allows PCBA 300 to be directly aligned with cover portion 402).

[0129] Fig.13A housing 400K having a cup-shaped cover portion 402K and a recessed landing pad 426K is shown. The housing 400K may have an attachment feature (e.g., a double-sided adhesive tape) for attaching the housing 400K to an orthopedic device, a body part of a patient, or another device or surface to be monitored. In some embodiments, the base portion 404K may include a pair of spaced apart slots or through holes 440K. The spaced apart slots 440K may allow a zip tie or similar fastening device to pass through one slot and exit from the other slot to allow the zip tie to fasten the base portion 404K to another structure (e.g., an orthopedic device). The zip tie fastener may be an uncommon color (e.g., orange) or include a unique marking pattern to help detect whether the original zip tie has been removed and replaced with another zip tie. The user may remove the zip tie to detach the activity monitoring device 120K from the orthopedic device so as to make it unclear whether the user complies with the instructions for use of the orthopedic device. In some embodiments, an adhesive may be used to secure the base portion 404K to another structure (e.g., an orthopedic device). The base portion 404K may include a recessed portion to receive an adhesive (eg, double-sided tape).

[0130] Fig.14 The inner surface 420L of an embodiment of the cover portion 402L is shown. The cover portion 402L may include one or more pins 450L. In the illustrated embodiment, the cover portion 402L includes four pins that are substantially equally spaced around the perimeter of the cover portion 402L. The pins 450L may be adapted to assist in proper alignment of the cover portion 402L with the PCBA 300. The pins 450L may have a layered column structure, wherein the pin portion 452L extends from the shaft portion 454L. In some arrangements, the pin portion 452L fits into a recess on the PCBA 300 so that the PCBA 300 is properly oriented relative to the cover portion 420L. The shaft portion 454L may have a seat surface 456L that rests on a cover-facing surface of the PCBA 300. The seat surface 456L may be arranged to transmit a non-targeted compressive force to a portion of the PCBA 300 that contacts the seat surface 456L. Seat surface 456L can direct the untargeted compressive force away from portions of PCBA 300 having sensitive components that may be damaged by such compressive forces. In this way, pin 450L can direct the untargeted compressive force to the portion of PCBA 300 that contacts seat surface 456L. Inner surface 402L can include a cored region 460L disposed between pillars 430L. Cored region 460L can be arranged to reduce the weight of cover portion 402L. In some variations, cored region 460L and pillars 430L are arranged to provide a light guide that prevents or reduces light from a light source illuminated on PCBA 300 from spreading to and illuminating other areas of cover portion 402L.

[0131] Fig.15A and15B The inner surface of the base portion 404L is shown, Fig.14 4. The inner surface of the cover portion 402L of the housing 400L is shown in FIG. The housing 420L may include a recessed landing pad 426L adapted to guide a user's thumb into a suitable position for activating the micro switch 302 of the PCBA 300, as described herein.

[0132] Fig. 15C and 15D Shows Fig.15A and 15B A close up view of housing 400L is shown in FIG. Fig.15D The top panel of FIG. 4 shows the cover portion 402L assembled to the base portion 404L without applying an adhesive to secure the cover portion 402L to the base portion 404L. Fig.15D As shown in the top panel of FIG. 4 , a small gap between the cover portion 402L and the base portion 404L in the assembled state can accommodate the thickness of the applied adhesive that secures the cover portion 402L to the base portion 404L. In some embodiments, the gap can be adapted to allow the PCBA 300 to be slightly clamped between the cover portion 402L and the base portion 404L after the housing 400L is glued closed. Fig.15D The bottom panel of 400L shows that the adhesive can fill the gap when the cover portion 402L and the base portion 404L are securely glued together and the housing 400L is sealed.

[0133] Fig.16 As shown, PCBA 300 may be housed in cover portion 402L and may include a sensor (eg, a motion sensor) or another electronic or non-electronic component (eg, a wireless communication device).

[0134] Assembly and attachment of activity monitoring devices

[0135] Fig.17A and 17B An embodiment of an activity monitoring device 120M including a dressing 150M is shown. The activity monitoring device 120M may be an example implementation of the activity monitoring device 20. Fig.17A As shown, the housing 400M may have a cover portion 402M and a base portion 404M. The cover portion 402M and the base portion 404M may be coupled together to form a closed space within the housing 400M. The size of the closed space may be set to accommodate at least the PCBA 300. Fig.17AIn the illustrated embodiment, the base portion 404M has an inner edge 406M that is nested within an outer sidewall 408M disposed on the cover portion 402M to form an enclosed space. As previously discussed, in some embodiments, the orientation of the inner edge 406M and the outer sidewall 408M can be reversed, such that the inner edge 406M is disposed on the cover portion 402M and the outer sidewall 408M is disposed on the base portion 404M, such as Figure 3A shown.

[0136] Activity monitoring device 120M may be assembled with power source 228M (eg, a battery). Activity monitoring device 120M may be sealed to enclose components within housing 400M. Housing 400M may be covered with a film to reduce contact with housing material.

[0137] Activity monitoring device 120M may include dressing 150M to fix activity monitoring device 120M to body part or orthopedic device. In some embodiments, housing 400M and dressing 150M may be pre-assembled by manufacturer, wherein housing 400M adheres to dressing 150M. In other embodiments, housing 400M and dressing 150M may be provided separately by manufacturer, and are configured to be adhered to each other by user. Dressing 150M may include frame delivery layer 152M, film layer 154M and release handle 156M. Release handle 156M may include or be provided with belt, such as surgical tape, which can be used for clinician to write information. Housing 400M may be attached to dressing 150M in a variety of ways as discussed herein. Frame delivery layer 152M may be the upper carrier layer of film layer 154M. Frame delivery layer 152M may be removed to expose or reveal the non-adhesive upper surface of film layer 154M. The size of the membrane layer 154M can be set to cover the outer diameter of the housing 400M or the patient's body part 110 or other object. The membrane layer 154M can be larger than the housing 400M. The size of the membrane layer 154 can vary. In certain embodiments, the width or length of the membrane layer 154 can be in the range of 5cm to 20cm, for example, 6cm to 15cm or 10cm to 12cm. In some embodiments, the width or length of the membrane layer 154M can be 1.25, 1.5, 1.75, 2, 2.5 or 3 times or more of the diameter or length of the housing 400M.

[0138] Fig.18 An embodiment of the power supply 228 is shown partially inserted into the associated mount 502. After the power supply 228 is fully inserted into the associated mount 502, the power supply 228 and the associated mount 502 are ready to be connected to the PCBA 300 and inserted and sealed within the housing 400M.

[0139] Fig.19A , 19B and 19C can be similar to the features shown in reference Fig.14Those described. Cover portion 402N may include one or more pins 450N. Cover portion 402N may, for example, include four pins that are substantially equally spaced around the perimeter of cover portion 402N. Pins 450N may assist in proper alignment of cover portion 402N with PCBA 300. Pins 450N may have a layered column structure in which a pin portion extends from a shaft portion. Pins 450N may also have a straight column structure in which each of pins 450N has a uniform diameter.

[0140] Fig.19B The power supply 228 and PCBA 300 are shown properly aligned to be positioned within the cover portion 402N, and Fig.19C The power supply 228 and PCBA 300 are shown positioned within the cover portion 402N. As previously described, the cover portion 402N can be arranged so that when the activity monitoring device 120M is assembled, the raised boss 422N is longitudinally aligned above the top of the button 304 of the micro switch 302. The recessed hole 424N can reduce the support of the raised pad on the outer surface of the cover portion 402N so that the compressive force applied to the raised pad causes the raised boss 422N to move toward the button 304. The housing 400 can be arranged so that the compressive force applied to the raised pad activates the micro switch 302 when the compressive force is applied substantially parallel to the longitudinal axis 10 of the activity monitoring device 120M, and does not activate when the compressive force is not applied substantially parallel to the longitudinal axis 10. The cover portion 402N can have an inner surface 420N. The inner surface 420N has a raised boss 422N extending from a recessed hole 424N that circumferentially surrounds the raised boss 422N.

[0141] like Fig.19C As shown, each of the pins 450N can fit into a notch on the PCBA 300 so that the PCBA 300 is properly oriented relative to the cover portion 402N. The inner surface 420N can include a cored area 460N disposed between the pillars 430N. The cored area 460N can reduce the weight of the cover portion 402N. In some variations, the cored area 460N and the pillars 430L can provide a light guide that prevents or reduces light from a light source illuminated on the PCBA 300 from spreading to and illuminating other areas of the cover portion 402N.

[0142] Fig. 20A and 20B A side view and a top view of the base portion 404P are shown, respectively. The base portion 404P has an inner edge 406P that is nested within an outer sidewall provided on the cover portion to form an enclosed space. Adhesive 470P is also shown as being applied around the periphery of the base portion 404P. Adhesive 470P can be applied on a horizontal surface around the inner edge 406P that extends radially inward from the outermost wall of the base portion 404P.

[0143] Once adhesive 470P can be applied, the cover portion can be placed on the top of the base portion 404P and gently pressed into place to package the components. The pressure applied may be enough to eliminate bubbles, and minimize the distance bridged by adhesive 470P between the base portion 404P and the cover portion. For example, in some embodiments, a pressure of 10N can be applied. Excessive adhesive 470P can be wiped off with a scraper or another appropriate utensil. Adhesive 470P can be, for example, an instant adhesive (e.g., Loczer 431) with low viscosity, and can be used to bond plastic and elastomeric materials with relatively fast fixation. The adhesive can be air cured for one to several minutes. In some embodiments, a substrate such as Locelle 770 or 7239 can also be used.

[0144] Fig.21 Wrapper 480 is shown positioned to be applied to housing 400Q. Housing 400Q may then be covered by wrapper 480, which may be a film, to reduce contact with housing 400Q. In some embodiments, housing 400Q may not be wrapped.

[0145] The wrapper 480 may be a circle sized to cover the housing 400Q. For example, the wrapper 480 may be a circle with a diameter of approximately 5 cm. The wrapper 480 may be a film, such as a retaining strip used with a wound dressing, and may be first applied to the outer surface of the cover portion of the housing 400Q. The wrapper 480 may be wrapped around the housing 400Q to cover all surfaces exposed to the environment.

[0146] Wrapper 480 can be covered by the first carrier layer and the second carrier layer, and the first carrier layer and the second carrier layer can be made of paper. Wrapper 480 (comprising both the first carrier layer and the second carrier layer) can be placed on a work surface. The first carrier layer can be removed from wrapper 480 to expose the sticky surface or adhesive surface of wrapper 480. When the exposed sticky surface faces upward, housing 400Q can be placed centered on wrapper 480. Then the second carrier layer can be removed to wrap packaging material 480 around housing 400Q. Fig.21 The direction in which the packaging material 480 is wrapped around the housing 400Q is further shown by arrows.

[0147] Fig.22A , 22B22C illustrate the process of attaching the housing 400R to the dressing 150R. The adhesive 470R can be applied to the lower surface of the base portion 404R of the housing 400R. The adhesive 470R can be applied in a variety of ways (e.g., with a pipette). The adhesive 470R can be applied centrally to the base portion 404R. The adhesive 470R can be applied, for example, to approximately half of the surface area of ​​the base portion 404R, such as Fig.22A as shown in .

[0148] exist Fig. 22B In the embodiment, the shell 400R can be placed on the film layer 154R of the dressing 150R.

[0149] In one example, the dressing 150R can have a 6 cm x 7 cm film layer 154R with fully expanded A8 adhesive on the lower surface of the film layer 154. The base portion 404R to which the adhesive 470R is applied can be placed on the upper surface of the film layer 154R. The base portion 404R can be placed centrally on the upper surface of the film layer 154R. Light pressure can be applied to the shell 400R against the upper surface of the film layer 154R to evenly distribute the adhesive 470R. Fig. 22B As shown, adhesive 470R may also be applied around the perimeter of base portion 404R to further secure housing 400R to the upper surface of membrane layer 154R. Membrane layer 154R may be moisture vapor permeable.

[0150] Fig. 22C The housing 400R is shown with the film layer 154R placed on a curing rack 500, such as an ultraviolet (UV) curing rack. The housing 400R with the film layer 154R can be positioned so that the film layer 154R can be located on opposite sides of the housing 400R from the curing rack 500. The housing 400R can be centrally placed on the curing rack 500. The housing 400R can be in physical contact with the curing rack 500 to increase UV penetration. The housing 400R with the film layer 154R can be cured for a period of time, for example, 60 seconds.

[0151] With the housing 400R sufficiently secured to the dressing 150R, the dressing 150R may be secured to a body part of a patient or another object, such as an orthopedic device. Fig.17A As described, release handle 156M can be provided as a lower carrier layer on film layer 154R. Release handle 156R can be removed to expose or reveal the adhesive lower surface of film layer 154R. The adhesive lower surface of film layer 154R may include fully expanded A8 adhesive, which is configured to adhere to a body part or other object.

[0152] In another example, the dressing 150R may have a 10 cm x 12 cm film layer 154R with fully expanded A8 adhesive on the lower surface of the film layer 154R. The housing 400R may be attached to the dressing 150R and used in conjunction with the Figures 22A-22C The process described is similar to the process of securing to a patient or another surface. In other examples, the membrane layer 154R may have different dimensions.

[0153] Fig.23A and 23B 1 and 2 are top and side views of a housing 400S positioned on a dressing 150S, respectively. The dressing 150S may include a contact layer 160S, which may be made of silicone. The contact layer 160S may be, for example, a circular layer sized (e.g., approximately 5 cm in diameter) to overlie the bottom surface of the housing 400S. The housing 400R may be attached to the dressing 150S and used in conjunction with the Figures 22A-22C The process described is similar to the process for securing to a patient or another surface.

[0154] like Fig. 23B As shown, dressing 150S may include frame delivery layer 152S, film layer 154S, adhesive expansion layer 158S, contact layer 160S, and release handle 156S. Frame delivery layer 152S may be an upper carrier layer of film layer 154S. Release handle 156S may be a lower carrier layer of film layer 154S.

[0155] To manufacture Fig.23A The dressing 150S shown may provide a previously manufactured film layer 154S with an adhesive expansion layer 158S. At least the release handle 156S may have covered the adhesive expansion layer 158S. The film layer 154S (wherein the release handle 156S covers the adhesive expansion layer 158S) may be placed on a work surface with the release handle 156S facing upward. The release handle 156S may be removed to expose the adhesive expansion layer 158S, which may be a sticky surface. The adhesive expansion layer 158S may be a fully expanded A8 adhesive.

[0156] A contact layer 160S, which may be made of silicone, may be provided, which includes an adhesive expansion layer on one or both sides thereof. The contact layer 160S may be covered with a first carrier layer or a second carrier layer on one or both sides. The first carrier layer may be removed to expose the sticky first surface of the contact layer 160S. The sticky first surface may be an adhesive expansion layer covering one side of the contact layer 160S. The adhesive expansion layer of the contact layer 160S may be applied centrally to the adhesive expansion layer 158S. Pressure may be applied to fix the contact layer 160S to the adhesive expansion layer 158S. The contact layer 160S may be perforated or moisture permeable.

[0157] The second carrier layer of the contact layer 160S may be removed to expose the second surface of the contact layer 160S. The release handle 156S that may have been previously removed as described above may be reapplied to cover the contact layer 160S and the adhesive expansion layer 158S of the film layer 154S. Thus, the contact layer 160S is surrounded by the adhesive expansion layer 158S. The housing 400S may be formed by contacting the membrane layer 154S with the adhesive expansion layer 158S. Fig.22A , 22B , 22C are attached to the dressing 150S by substantially the same or similar process as described above. The shell 400S can be attached to the dressing 150S before or after assembling the dressing as described above. The shell 400S is attached to the film layer 154S. The film layer 154S may have an adhesive expansion layer 158S, which is attached to the contact layer 160S. The contact layer 160S can be sized to cover the entirety of the shell 400S so that the area of ​​the contact layer 160S is at least as large as the area of ​​the lower surface of the shell 400S. In use, the release handle 156S can be removed to expose the sticky surface of the contact layer 160S and the sticky surface of the film layer 154S, both of which can be used to adhere the dressing to the patient's body part 110 or other object. The film layer 154S can be moisture permeable, and as described above, the contact layer can also be moisture permeable.

[0158] In some embodiments, a reusable or resealable adhesive may be used under the housing 400S and a disposable adhesive may be used around the edges of the dressing 150S. The disposable adhesive may serve both to provide an attachment force and as a tamper-evident attachment to the user. In other embodiments, other tamper-evident mechanisms may be used in addition or in lieu thereof, such as a shear layer, stress-evident printing, etc.

[0159] Fig.23C An embodiment of an activity monitoring device 120S including a dressing 150S is shown. The activity monitoring device 120S may be an example implementation of the activity monitoring device 20. The contact layer ( Fig.23C The dressing 150S may be 10 cm x 10 cm. The housing 400S may be shaped similar to the Fig.22A -C, 23A and 23B are attached to the dressing 150S in a similar manner.

[0160] like Fig.23C As shown in , the dressing 150S can be at least partially quadrilobate. The dressing 150S can have one, two, or more release handles 156S. The dressing 150S can include an optional frame delivery layer ( Fig.23C Not shown), membrane layer 154S, adhesive expansion layer 158S, contact layer ( Fig.23C 158S) and two release handles 156S. The adhesive expansion layer can be perforated. Alternatively, layer 158S can be a contact layer.

[0161] The frame delivery layer may be an upper carrier layer of the film layer 154S. The release handle 156S may be a lower carrier layer, adhesive expansion layer 158S or contact layer (not shown) of the film layer 154S. Both the film layer 154S and the release handle 156S may be cut into similar strips or shapes.

[0162] In another example, to produce Fig.23A The dressing 150S shown may provide a previously manufactured film layer 154S having an adhesive expansion layer 158S. At least the release handle 156S may have covered the adhesive expansion layer 158S. The film layer 154S (wherein the release handle 156S covers the adhesive expansion layer 158S) may be placed on a work surface with the release handle 156S facing upward. The release handle 156S may be removed to expose the adhesive expansion layer 158S, which may be a sticky surface. The adhesive expansion layer 158S may be a fully expanded K5 adhesive layer. A contact layer 160S, which may be made of silicone, may be provided, which includes an adhesive expansion layer on one or both sides thereof. The contact layer 160S may be covered with a first carrier layer or a second carrier layer on one or both sides. The first carrier layer of the contact layer 160S may be removed to expose the sticky surface of the contact layer 160S. The contact layer 160S may be placed on a work surface with the second carrier layer facing downward.

[0163] The release handle 156S can be removed to expose the adhesive expansion layer 158S, which can be a sticky lower surface of a K5 adhesive layer. With the film layer 154S and the contact layer 160S aligned, the adhesive expansion layer 158S can be placed onto the contact layer 160S. The second carrier layer of the contact layer 160S can be removed to expose the adhesive layer.

[0164] The release handles 156S may be perforated or folded. One of the release handles 156S may be perforated and folded and may be applied to the contact layer 160S or the adhesive layer of the contact layer 160S. The other of the release handles 156S may be applied to the contact layer 160S or the adhesive layer of the contact layer 160S. The release handles 156S may be applied so that there is an overlap between the two release handles 156S. The overlap between the two frame delivery handles may be about or at least 2.5 cm.

[0165] Housing 400S can be connected with Fig.22A -C is attached to dressing 150S by substantially the same or similar process as described above.

[0166] The release handle 156S may be removed to expose the adhesive surfaces of the contact layer 160S and the membrane layer 154S, both of which may be adhered to the patient's body part 110 or other object.

[0167] Fig.24A An embodiment of a cover portion 402T is shown. Fig. 24B and 24C Side and perspective views of an embodiment of a base portion 404T are shown. Fig.24A , 24B and 24C may be similar to the features shown in Fig.19A , 19B and those described in connection with FIGS. 19C and 19C. Cover portion 402T and base portion 404T may be substantially similar to cover portion 402N and base portion 404N.

[0168] However, in addition to the cover portion 402T having the inner surface 410T having the raised boss 422T extending from the recessed hole 424T circumferentially surrounding the raised boss 422T, the recessed hole 424T may also include an additional recess 425T recessed from the recessed hole 424T. In certain embodiments, the additional recess 425T may advantageously increase the transparency of the cover portion 402T at the additional recess 425T, such that the additional recess 425T allows light emitted from a lamp mounted on the PCBA 300 to pass through the cover portion 402T to the outside of the cover portion 402T. The additional recess 425T may additionally control the profile or clarity of light visible from the outside of the cover portion 402T.

[0169] The base portion 404T may include a bottom outer surface 435T, a lower outer surface 436T, an intermediate outer surface 437T, an upper outer surface 438T, and a top outer surface 439T. The lower outer surface 436T and the upper outer surface 438T may be angled at ∠A and ∠B, respectively, relative to the top outer surface 439T. ∠A may be the same as or different from ∠B. For example, ∠A or ∠B may be an angle in the range of 0° to 70°, such as an angle of 2°, 3°, 5°, 7°, or 10°. When attached to the base portion 404T, the corresponding portions of the cover portion 402T located adjacent to the lower outer surface 436T and the upper outer surface 438T may be angled to match ∠A and ∠B, and facilitate the fit between the cover portion 402T and the base portion 404T. In certain embodiments, the angles of the lower and upper outer surfaces 436T, 438T relative to the top outer surface 439T can desirably increase the surface area of ​​the bottom outer surface 435T available for attaching the base portion 404T (eg, to a dressing described herein).

[0170] In some embodiments, the base portion 404T can be flared, flanged, or winged at the bottom outer surface 435T. The flare, flange, or wing can facilitate the use of a layer for securing the base portion 404T, wherein the layer has a hole through which the flare, flange, or wing may not pass, but through which the remainder of the base portion 404T may pass. The layer may be part of the dressing or may be attached to the dressing.

[0171] The base portion 404T may have one or more surfaces having a surface roughness greater than other surfaces of the base portion 404T to promote and enhance adhesion of the adhesive to the surface having the greater surface roughness. Additionally or alternatively, the base portion 404T may have one or more textured surfaces that promote and enhance adhesion of the adhesive to the textured surface.

[0172] In some embodiments, the bottom outer surface 435T of the base portion 404T may include one or more channels (not shown). The one or more channels may allow air or fluid to flow and may help to prevent moisture accumulation below the bottom outer surface 435T. The one or more channels may reduce the lateral stiffness of the base portion 404T to improve the damping, Young's modulus, or lateral shear modulus of the base portion 404T.

[0173] Fig.25A , Fig.25B and 25C An embodiment of an activity monitoring device 120U including a dressing 150U is shown. The activity monitoring device 120U may be an example implementation of the activity monitoring device 20. Fig.25A As shown and described with respect to other embodiments herein, the housing 400U can have a cover portion 402U and a base portion 404U. The cover portion 402U and the base portion 404U can be joined together to form an enclosed space within the housing 400U. The size of the enclosed space can be set to accommodate at least PCBA 300. The activity monitoring device 120U can be assembled with a power source 228U (e.g., a battery). The activity monitoring device 120U can be sealed to enclose the components within the housing 400U. The housing 400U can be covered with a film to reduce external contact with the housing material.

[0174] Activity monitoring device 120U may include dressing 150U to secure activity monitoring device 120U to a body part or orthopedic device. In some embodiments, housing 400U and dressing 150U may be pre-assembled by a manufacturer, with housing 400U adhered to dressing 150U. In other embodiments, housing 400U and dressing 150U may be provided separately by a manufacturer and configured to be adhered to each other by a user.

[0175] The dressing 150U may include a frame delivery layer 152U, an adhesive expansion layer 158U, a contact layer 160U, a film layer 154U, and a release handle 156U. The release handle 156U may include or be provided with a tape (e.g., surgical tape) that can be used for a clinician to handwrite information. The frame delivery layer 152U may be an upper carrier layer of the film layer 154U.

[0176] The dressing 150U may include a spacer layer 164U to achieve breathability by providing an air gap between the patient's skin (or another surface) and the housing 400U. The air gap may allow fluid vapor to escape. The contact layer 160U may be an adhesive to help the spacer layer 164U adhere to the housing 400U. The contact layer 160U may be perforated or moisture permeable, which may be advantageous for breathability.

[0177] The membrane layer 154U may be sized to cover the outer diameter of the shell 400U or the patient's body part 110 or other object. The membrane layer 154U may be larger than the shell 400U. The size of the membrane layer 154U may vary. The shell 400U may be attached to the dressing 150U in a variety of ways as discussed herein.

[0178] The activity monitoring device 120U may include a formed film dressing 162U. The formed film dressing 162U may be used to secure the housing 400U to the dressing 150U. The formed film dressing 162U may be made of an adhesive film. The adhesive film may be an IV3000 dressing, for example, an Opsite Flexigrid dressing, or another adhesive film dressing for wound care. The adhesive may be a medical or healthcare grade adhesive. Alternatively, the adhesive may be an adhesive film that is tolerable to human skin. The adhesive on the film may be an acrylic or silicone gel. The use of the formed film dressing 162U may enable coupling without the use of an adhesive extension layer of a contact layer that adheres to an adhesive extension layer of the dressing 150U. The contact layer 160U may be an adhesive to assist in retaining the spacer layer 164U. The contact layer 160U may be made of silicone.

[0179] like Fig.25A , 25BAs shown in Figures 25C and 25C, the shaped film dressing 162U can be vacuum formed above the housing 400U to hold the housing 400U to the film layer 154U of the dressing 150U. The shaped film dressing 162U can be stretched above the housing 400U. The adhesive can be located between the shaped film dressing 162U and the film layer 154U. The shaped film dressing 162U and the film layer 154U can be clamped together in the bracket to prevent separation. The size of the shaped film dressing 162U can be set to receive and enclose each of the housing 400U, the spacer layer 164U, the adhesive expansion layer 158U or the contact layer 160U. The size of the shaped film dressing 162U can be set to be larger than the housing 400U, the spacer layer 164U, the adhesive expansion layer 158U or the contact layer 160U. The shaped film dressing 162U may include a border to surround the enclosed components and be fixed to the film layer 154U. In the illustrated embodiment, the contact layer 160U is shown disposed between the membrane 154U and the spacer 164U. Additionally and alternatively, the dressing 150U may include a contact layer 160U disposed between the membrane 154U and the release handle 156U.

[0180] Fig.26A , 26B and 26C may be similar to the features shown in Figures 25A-25C Those characteristics described. Fig.26A As shown, the housing 400V may have a cover portion 402V and a base portion 404V. The cover portion 402V and the base portion 404V may be coupled together to form an enclosed space within the housing 400V. The size of the enclosed space may be set to accommodate at least the PCBA 300. The activity monitoring device 120V may be assembled with a power source 228V (e.g., a battery).

[0181] Activity monitoring device 120V may include a dressing 150V to secure activity monitoring device 120V to a body part or orthopedic device. Dressing 150V may include an adhesive expansion layer 158V, a contact layer 160V, and one or more release handles 156V. Dressing 150V may include a spacer layer 164V to achieve breathability by providing an air gap between the patient's skin (or another surface) and housing 400V. The air gap allows fluid vapor to escape. Contact layer 160V may be an adhesive to help spacer layer 164V adhere to housing 400V. Contact layer 160V may be perforated or moisture-permeable, which may be advantageous for breathability.

[0182] The housing 400V can be attached to the dressing 150V in a variety of ways as discussed herein. The activity monitoring device 120V may include a formed film dressing 162V. The formed film dressing 162V can be used to fix the housing 400U or the dressing 150V to the patient's skin or another surface. The formed film dressing 162V can also be used to fix the housing 400U to the dressing 150V. The formed film dressing 162V can be made of an adhesive film. The adhesive film can be an IV3000 dressing, for example, an Opsite Flexigrid dressing, or another adhesive film dressing that has been used for wound care. The adhesive can be an adhesive of medical or healthcare grade. The adhesive can be an adhesive film that can be tolerated by human skin. The adhesive on the film can be acrylic or silicone gel. The use of the formed film dressing 162V can achieve connection without the use of an adhesive extension layer of the contact layer to adhere to the adhesive extension layer of the dressing 150V. The contact layer 160V can be an adhesive to assist in retaining the spacer layer 164V. The contact layer 160U may be made of silicone.

[0183] like Fig.26A , 26B , 26C, the shaped film dressing 162V can be vacuum formed above the shell 400V to encapsulate the shell 400V and the dressing 150V. The shaped film dressing 162V can be stretched over the shell 400V. The adhesive can be located between the shaped film dressing 162V and the film layer 154V. The shaped film dressing 162V and the film layer 154V can be clamped together in a bracket to prevent separation. The size of the shaped film dressing 162V can be set to receive and encapsulate both the shell 400U and the dressing 150V, and adhere to the patient's skin or another surface. The size of the shaped film dressing 162V can be further set to be larger than the dressing 150V to surround the enclosed components and fix the shell 400V and the dressing 150V to the patient or another surface. The shaped film dressing 162V may include a border to surround the enclosed components and fix the shell 400V and the dressing 150V to the patient's skin or another surface.

[0184] Fig.27A and 27B Embodiments of a shell 400W and a dressing 150W are shown, and a method of coupling the shell 400W to the dressing 150W is shown. The dressing 150W may include a frame delivery layer 152W, a film layer 154W, and a release handle 156W. The shell 400W may be fixed to the dressing 150W using two adhesive expansion layers 158W. The dressing 150W may include a contact layer 160W located between the two adhesive expansion layers 158W. An adhesive expansion layer 158W may be positioned between the shell 400W and the contact layer 160W. An adhesive expansion layer 158W may be positioned between the contact layer 160W and the film layer 154W.

[0185] Fig.28A , 28B 28C show an embodiment of a housing 400X and a dressing 150X, and show a method of coupling the housing 400X to the dressing 150X. The dressing 150X may include a frame delivery layer 152X, a film layer 154X, and a release handle 156X. The dressing 150W may include a contact layer 160X located between the housing 400X and the film layer 154X. The housing 400X may be secured to the dressing 150Y using one or more adhesive film dressings 162X. Fig.28B and 28C Different configurations of one or more adhesive film dressings 162X positioned over housing 400X are shown. Fig.28B As shown, two strips of film dressing 162X may be substantially perpendicular to each other above housing 400X. Fig.28C As shown, three strips of film dressing 162X may extend radially over housing 400X relative to one another. Adhesive film dressing 162X may be an IV3000 dressing, for example, an Opsite Flexigrid dressing, or another adhesive film dressing used for wound care.

[0186] Fig.29A and 29B Embodiments of a housing 400Y and a dressing 150Y are shown, and a method of coupling the housing 400X to the dressing 150X is shown. The dressing 150Y may include a frame delivery layer 152Y, a film layer 154Y, and a release handle 156Y. The dressing 150Y may include a contact layer 160Y between the housing 400Y and the film layer 154Y. The housing 400Y may be fixed to the dressing 150Y, wherein the foam 166Y is positioned around the periphery of the housing 400Y. The foam 166Y may be annular, so that the foam 166Y is circular with a hole in the center to receive the housing 400Y. One or more layers of the foam 166Y may be used to fix the housing 400Y to the dressing 150Y. The housing 400Y may be fixed to the dressing 150Y with a film dressing 162Y. The film dressing 162Y can be an adhesive, for example, an IV3000 dressing, such as an Opsite Flexigrid dressing, or another adhesive film dressing for wound care. The film dressing 162Y can be evacuated over the housing 400X or the dressing 150Y, similar to as described with respect to other embodiments herein. The film dressing 162Y can be sized to fit over the housing 400Y, the foam 166Y, and at least a portion of the dressing 150Y.

[0187] Fig. 30A and 30BAn embodiment of a housing 400Z and a dressing 150Z is shown, and a method of coupling the housing 400Z to the dressing 150Z is shown. The dressing 150Z may include a frame delivery layer 152Z, a film layer 154Z, and a release handle 156Z. The dressing 150Z may include a contact layer 160Z between the housing 400Z and the film layer 154Z. The housing 400Z may be fixed to the dressing 150Z with a film dressing 162Z. The film dressing 162Z may be an adhesive, for example, an IV3000 dressing, such as an Opsite Flexigrid dressing, or another adhesive film dressing for wound care. The size of the film dressing 162Z may be set to fit over the housing 400Y, and at least a portion of the dressing 150Z. The film dressing 162Z may have a cutout hole to reduce the strain of the film dressing 162Z on the height of the housing 400Z.

[0188] Fig.31A and 31B An embodiment of a shell 600A and a dressing 550X is shown, and a method of coupling the shell 600A to the dressing 550X is shown. The dressing 550A may include a frame delivery layer 552A, a film layer 554A, and a release handle 556A. The dressing 550A may include a contact layer 560A between the shell 600A and the film layer 554A. The shell 600A may be fixed to the dressing 550A with a film dressing 562A. The film dressing 562A may be an adhesive, for example, an IV3000 dressing, such as an Opsite Flexigrid dressing, or another adhesive film dressing for wound care. The size of the film dressing 562A may be set to fit over the base portion 600A, and at least a portion of the dressing 550A. The film dressing 562A may be located between the cover portion 602A and the base portion 604A of the shell 600A. The film dressing 562A may be vacuumed over the base portion 604A of the housing 600A or the dressing 550A, similar to as described with respect to other embodiments herein. The film dressing 562A located between the cover portion 602A and the base portion 604A of the housing 600A may reduce strain on the film dressing 562A because it reduces the height of the film dressing 562A. The location of the film dressing 562A between the cover portion 602A and the base portion 604A may secure the film dressing 562A in place.

[0189] Fig.32A and 32BEmbodiments of a housing 600B and a dressing 550B are shown, and a method of coupling the housing 600B to the dressing 550B is shown. The dressing 550B may include a frame delivery layer 552B, a film layer 554B, and a release handle 556B. The dressing 550B may include a contact layer 560B between the housing 600B and the film layer 554B. The housing 600B may be fixed to the dressing layer 550B using two adhesive expansion layers 558B. An adhesive expansion layer 558B may be located between the housing 600B and the contact layer 560B. An adhesive expansion layer 558B may be located between the contact layer 560B and the film layer 554B. The housing 600B and the dressing 550B may be fixed to a patient or another surface with a film dressing 562B. The film dressing 562B may fix the housing 600B to the dressing 550B. The film dressing 562B can be an adhesive, for example, an IV3000 dressing, such as an Opsite Flexigrid dressing, or any other adhesive film dressing that has been used for wound care. The film dressing 562B can be vacuumed over the housing 600B or the dressing 550B, similar to as described with respect to other embodiments herein. The film dressing 562B can be sized to fit over the housing 600B and the dressing 550B to adhere to the patient's skin or another surface.

[0190] Fig.33A and 33B Embodiments of a shell 600C and a dressing 550C are shown, and a method of coupling the shell 600C to the dressing 550C is shown. The dressing 550C may include a frame delivery layer 552C, a film layer 554C, and a release handle 556C. The dressing 550C may include a contact layer 560C between the shell 600C and the film layer 554C. The shell 600C may be fixed to the dressing layer 550C using an adhesive extension layer 558C. The shell 600C and the dressing 550C may be fixed to a patient or another surface with a film dressing 562C. The film dressing 562C may fix the shell 600C to the dressing 550C. The film dressing 562C may be an adhesive, for example, an IV3000 dressing, such as an Opsite Flexigrid dressing, or any other adhesive film dressing that has been used for wound care. A vacuum may be drawn on the film dressing 562C over the housing 600C or the dressing 550C, similar as described with respect to other embodiments herein.The film dressing 162CC may be sized to fit over the housing 600C and the dressing 550C to adhere to the patient's skin or another surface.

[0191] Fig.34Embodiments of a shell 600D and a dressing 550D are shown, and methods of coupling the shell 600D to the dressing 550D are shown. The shell 600D can include fluid handling features, as described herein. In some aspects, the fluid handling features can facilitate wicking moisture away from the interface of the shell 600D and the dressing 550D. Wicking moisture away from the shell-dressing interface can facilitate maintaining the attachment of the shell 600D to the dressing 550D by preventing moisture from accumulating under the shell 600D and weakening the adhesive.

[0192] Continue to refer Fig.34 , the shell 600D may include one or more grooves or channels 606 on the outer surface of the shell 600D, which faces the dressing 550D when the shell 600D is coupled to the dressing 550D. The channel 606D may be adapted to provide moisture handling capabilities through the shell. The channel 606 may provide a path that allows moisture to travel from below the shell 600D to the periphery of the shell 600D. The channel 606 may be included in any of the shells described herein. In the illustrated embodiment, the channel 606 is shown as being on the base portion of the shell 600D. In some variations, the channel 606 may be provided on a ring or donut-shaped structure attached to the bottom surface of the base portion of the shell. In some variations, the entire shell has an annular or donut-shaped shape so that an open flow path is provided through the central core of the annular or donut-shaped shell 600D.

[0193] like Fig.34 As shown, the dressing 550D may include a fluid handling layer 170. The fluid handling layer 170 may be a wicking or acquisition distribution layer (ADL), a foam layer, or a spacer or transmission layer. The ADL can be configured to horizontally wick the fluid (e.g., wound exudate) as it is absorbed upward through the layers of the dressing 550D. In some aspects, the ADL may include viscose, polyester, polypropylene, cellulose, or a combination of some or all of these, and the material may be needle-punched. In some aspects, the ADL may include polyethylene in the range of 40-150 grams per square meter (gsm). In some aspects, the ADL may have a thickness of 1.2 mm or about 1.2 mm, or may have a thickness in the range of 0.5 mm to 3.0 mm or about 0.5 mm to about 3.0 mm.

[0194] The ADL can be constructed so as to advantageously wick the fluid horizontally as the fluid (e.g., wound exudate) is absorbed upward through the layers of the dressing 550D. The ADL may include cellulose in the range of 40-160 gsm (or about 40 to about 160 gsm), for example 80 (or about 80) gsm. The ADL may be constructed of a material that resists compression. The ADL material in an uncompressed state may be 0.5 mm to 3 mm thick or about 0.5 mm to about 3 mm thick, and in some embodiments may be 1.2 mm thick or about 1.2 mm thick in an uncompressed state. The ADL material may include a plurality of loosely filled fibers that may be arranged in a substantially horizontal fiber network.

[0195] In some aspects, the ADL material may be composed of a mixture of two fiber types. One fiber may be a flat fiber, whose width may be 20 μm to 50 μm, or a width of about 20 μm to about 50 μm, and may contain a cellulose-based material. Another fiber may be a two-component fiber, whose inner core has a diameter of 8 μm to 10 μm, or a diameter of about 8 μm to about 10 μm, and the thickness of the outer layer is 1 μm to 2 μm, or about 1 μm to about 2 μm. The two-component fiber may be a mixture of polyethylene (PE) type material and polyethylene terephthalate (PET). In some embodiments, the inner core of the two-component fiber may be PET and the outer layer may be PE. PE / PET fibers may have a smooth surface morphology, while cellulose fibers may have a relatively rough surface morphology. In some embodiments, the ADL material may contain about 60% to about 90% cellulose fibers, such as about 75% cellulose fibers, and may contain about 10% to about 40% PE / PET fibers, such as about 25% PE / PET fibers.

[0196] In some aspects, a majority of the fiber volume of the ADL may extend horizontally (i.e., parallel to the plane of the top and bottom surfaces of the material), or extend substantially or generally horizontally. In some variations, 80%-90% (or approximately 80% to approximately 90%) or more of the fiber volume of the ADL may extend horizontally, or substantially or generally horizontally. In another variation, a majority (80%-90% (or approximately 80% to approximately 90%)) or more of the fibers, or even all or substantially all of the fibers span a distance perpendicular to the thickness of the ADL material (a horizontal or lateral distance) that is greater than the thickness of the ADL material. In some embodiments, the horizontal or lateral distance spanned by such fibers is 2 times (or approximately 2 times) or more, 3 times (or approximately 3 times) or more, 4 times (or approximately 4 times) or more, 5 times (or approximately 5 times) or more, or 10 times (or approximately 10 times) or more of the thickness of the ADL material. Such orientation of fibers can promote lateral wicking of fluid through the ADL material. This may allow fluids such as wound exudate to be more evenly distributed throughout the ADL material.

[0197] In some aspects, the fluid handling layer 170 may be or include a spacer layer or a transmission layer. The spacer or transmission material may preferably be formed of a material having a three-dimensional structure, and may have a top layer and a bottom layer including a woven pattern. For example, a knitted or woven spacer fabric (e.g., Baltex 7970 weft-knitted needle polyester) or a non-woven fabric may be used. The top fabric layer and the bottom fabric layer may include polyester, such as 84 / 144 textured polyester or flat denier polyester. Of course, other materials and other fiber linear mass densities may be used. In some aspects, the top fabric layer and the bottom fabric layer may be the same pattern and the same material, while in other aspects, they may be different patterns and / or different materials. The number of filaments in the yarn used to form it in the top fabric layer may be more than the number of filaments in the yarn used to form the bottom fabric layer, so as to control the flow of moisture through the transmission layer. In particular, by having more filaments in the top layer (that is, the top layer is made of yarn having more filaments than the yarn used in the bottom layer), the liquid is more likely to be wicked along the top layer than the bottom layer.

[0198] In some aspects, the spacing or transmission layer may have most of the filaments (by volume), which extend vertically (that is, perpendicular to the plane of the top layer and the bottom layer) or substantially or substantially vertically. In some aspects, 80%-90% (or about 80% to about 90%) or more (by volume) of the filaments can extend vertically, or substantially or substantially vertically. In another variation, all or substantially all of the filaments (by volume) can extend vertically, or substantially or substantially vertically. In some aspects, most (80%-90% (or about 80% to about 90%)) of the filaments or more, or even all or substantially all of the filaments extend upwards from the bottom fabric layer and / or extend downwards from the top fabric layer, and in some aspects, such filaments extend in length to exceed more than half of the distance between the top fabric layer and the bottom fabric layer. In some aspects, a majority (80%-90% (or about 80% to about 90%)) or more, or even all or substantially all, of the filaments span a greater distance in a direction perpendicular to the top and bottom fabric layers (vertical direction) than in a direction parallel to the top and bottom fabric layers (horizontal direction). Such orientation of filaments can promote vertical wicking of fluid through the spacer layer. Such filaments can also keep the top and bottom layers spaced apart when the dressing 550D is exposed to compressive forces or negative pressure.

[0199] exist Fig.34 In the illustrated embodiment of the present invention, the fluid handling layer 170 is disposed between the housing 600D and the membrane layer 154D. Additionally or alternatively, the fluid handling layer 170 may be disposed at other locations within the dressing 550D. In some aspects, when the dressing 550D is attached to the skin of the wearer of the dressing 550D, the fluid handling layer 170 may be disposed at or near the skin interface. For example, the fluid handling layer 170 may be disposed between the contact layer 160D and the adhesive expansion layer 158D of the dressing 550D. Additionally or alternatively, the fluid handling layer 170 may be disposed between the release handle 156D and the wound contact layer 160D, so that when the release handle 156D is removed to apply the dressing 550D to the wearer's skin, the fluid handling layer 170 is in direct contact with the skin of the wearer of the dressing 550D. Additionally or alternatively, the fluid handling layer 170 may be sandwiched between the contact layer 160D and the adhesive expansion layer 158D. The dressing 550D may include different types of fluid management layers 170. For example, the dressing 550D may have a first fluid management layer 170 that is a foam layer disposed between the contact layer 160D and the adhesive expansion layer 158D, and a second fluid management layer 170 that is an ADL disposed between the shell 600D and the membrane layer 154D. All combinations of possible foregoing arrangements of fluid management layers 170 in the dressing 550D are within the scope of the present disclosure and are omitted for clarity.

[0200] Fig.35 Embodiments of a shell 600E and a dressing 550E are shown, and methods of coupling the shell 600E to the dressing 550E are shown. As described above, the shell 600E shown includes a plurality of grooves or channels 606. In some variations, the shell 600E does not include any grooves or channels 606. The dressing 550E may include a fluid handling layer 170 disposed between the membrane layer 154E and the contact layer 160E. In some aspects, the fluid handling layer 170 is a foam. In some variations, the dressing 550E may be ALLEVYN sold by Smith & Nephew. TM Dressings (eg, ALLEVYN TM LIFE dressing) or any other suitable dressing.

[0201] Fig.36 A non-limiting exemplary embodiment of a dressing 550E is shown. The dressing 550E may have multiple layers and the multiple layers may be arranged to Fig.36 For example, the dressing 550E may include a film layer 154E and an optional bottom wound contact layer 160E ( Fig.36154E). In some embodiments, the dressing 550E may include a bottom wound contact layer 160E (not shown) attached to the bottom surface of the adhesive expansion layer 158E (e.g., a silicone adhesive layer). In some variations, the film layer 154E may be permeable to moisture and / or air. The dressing 550E may include various layers located between the wound contact layer 160E and the film layer 154E. For example, the dressing 550E may include one or more absorbent layers 180 or one or more fluid handling layers 170. In some aspects, the dressing 550E may include a perforated wound contact layer 160E and a top film layer 154E. In the illustrated embodiment, the wound contact layer 160E is not shown because it is obscured by the adhesive expansion layer 158E, which directly overlies the wound contact layer 160E. Other components of the dressing 550E may include a fluid handling layer 170, which is a foam layer (e.g., a polyurethane water foam foam layer) having a suitable size to cover a recommended wound size corresponding to the specific dressing size selected. An optional activated carbon cloth layer (not shown) of similar or slightly smaller size than the foam layer may be provided to allow for odor control. An absorbent layer 180 of slightly larger size than the foam layer may be provided over the foam layer 170, such as a layer of superabsorbent airlaid material containing cellulose fibers and superabsorbent polyacrylate particles, and may allow for superabsorbent material overlap and may act as a leak prevention. A masking or covering layer 190, such as a three-dimensionally woven spacer fabric layer, may be provided over the absorbent layer 180 to provide protection from pressure while allowing for partial masking of the top surface of the superabsorbent that retains the colored exudate. The smaller size of the masking layer 190 (in plan view) compared to the absorbent layer 180 may allow the edges of the absorbent layer 180 to be visible, which may be used by a clinician to assess whether a dressing change is needed.

[0202] The shell 600E can be attached to the outer surface of the membrane layer 154E so that the membrane layer 154E is sandwiched between the shell 600E and the masking layer 190. In some aspects, placing the shell 600E on top of the foam-containing dressing 550E can reduce the possibility of the shell 600E falling off the dressing 550E due to impact to the shell 600E. Fig.35 As shown, the shell 600E can be adhered to the outer surface of the membrane layer 154E. In this position, when the shell 600E is impacted or moved by external forces, the foam (e.g., the fluid handling layer 170) will allow the shell 600E to move, thereby reducing the force applied to the skin and / or the adhesive expansion layer 158E of the dressing 550E. In some aspects, the foam can help the contact layer 160E conform to the curvature of the wearer's body shape. The foam can be compressed as needed to allow the rigid flat base of the shell 600E to rest more comfortably on top of the wearer's skin.

[0203] Return to Fig.35The dressing 550E may optionally include a cushioning layer 172 disposed beneath the shell 600E. In some variations, the cushioning layer 172 may be OPSITE sold by Smith & Nephew. TM The dressing or a portion thereof or any other suitable dressing may be visible postoperatively. For example, the cushioning layer 172 may include a foam having an opening or slit therein. Other details of the cushioning layer 172 are found in International Application No. PCT / US2007 / 079529, filed on September 26, 2006, entitled "LATTICE DRESSING", which was published as International Publication No. WO 2008 / 039839 on April 3, 2008, and is incorporated herein by reference in its entirety. In some variations, the cushioning layer 172 may be a contact layer 160 (e.g., a silicone wound contact layer 160). The cushioning layer 172 may cushion the area below the shell 600E and provide the ability for moisture to move below and around the shell 600E. In some variations, the dressing 550E does not include a cushioning layer 172. For example, the shell 600E may be directly adhered to the ALLEVYN TM The outer surface of the film layer 154E of the dressing.

[0204] As discussed, as described herein, the shell 600E can be adhered to the dressing 550E using an adhesive (e.g., a UV-curable adhesive, an ostomy adhesive, a hydrocolloid adhesive). In some variations, the UV-curable adhesive is applied to the bottom surface of the shell 600E, which is then placed on the outer surface of the membrane layer 154E to form an assembly. The assembly can be placed in a first position on the curing frame 500 ( Fig. 22C ) on the curing rack 500 so that the dressing 550E is disposed between the shell 600E and the curing rack 500. With the assembly on the curing rack 500 in the first position, the curing process can be set to last about 30 seconds. In some aspects, the assembly of the shell 600E and the dressing 550E can be placed on the curing rack 500 in the second position so that the shell 600E is in direct contact with the curing rack 500 and is disposed between the curing rack 500 and the dressing 550E. In some aspects, the curing process can be performed for about 60 seconds with the assembly on the curing rack 500 in the second position. In some variations, the method includes: performing the curing process for 30 seconds with the assembly in the first position; moving the assembly to the second position; and performing the curing process for 60 seconds with the assembly in the second position.

[0205] Exemplary Embodiments

[0206] An activity monitoring device for positioning on a user's body or on an orthotic device is disclosed. The activity monitoring device may include: a housing including a cover portion and a base portion, wherein the cover portion includes an inner edge extending from an upper wall of the cover portion, a recessed portion disposed on a surface of the upper wall facing the base, and a boss extending from the recessed portion, wherein the base portion includes an outer side wall extending from a surface of the base portion facing the cover, the inner edge and the outer side wall may contact each other to form a closed space therebetween, and the thickness of the upper wall at the recessed portion is thinner than the thickness of the upper wall outside the recessed portion; a circuit board assembly located in the cover portion, wherein the circuit board assembly includes a controller and a button, the button being pressable by the boss to activate the controller; and a power supply located in the cover portion and configured to power the controller.

[0207] The activity monitoring device of the previous paragraph may include one or more of the following features: The activity monitoring device may also include a sensor, which is a gyroscope, a magnetometer, an accelerometer, a barometer, a light sensor, and a temperature sensor. The sensor may detect movement of the shell. The controller may use the sensor to monitor the movement of the shell. The controller may store the movement of the shell to a memory device and output the movement of the shell to the electronic device via a communication interface. The activity monitoring device may also include a light source disposed on the circuit board assembly, which is arranged to illuminate through the recessed portion when the light source is activated. The cover portion may include one or more pins for aligning the circuit board assembly with the cover portion. The activity monitoring device may include a dressing, which includes an upper surface and a lower surface, wherein the base portion is configured to adhere to the upper surface. The activity monitoring device may include an orthotic device, wherein the base portion is configured to adhere to the orthotic device.

[0208] Other variations and terms

[0209] Any values ​​of threshold values, limits, durations, etc. provided herein are not intended to be absolute, and therefore may be approximate. In addition, any threshold values, limits, durations, etc. provided herein may be fixed or automatically or changed by a user. In addition, relative terms such as exceeding, greater than, less than, etc. relative to a reference value as used herein are intended to also encompass equal to a reference value. For example, exceeding a positive reference value may include being equal to or greater than a reference value. In addition, relative terms such as exceeding, greater than, less than, etc. relative to a reference value as used herein are also intended to encompass the opposite of the disclosed relationship, such as being lower than, less than, greater than, etc. relative to a reference value. In addition, although the boxes of various processes may be described in terms of determining whether a value meets or does not meet a particular threshold, these boxes may be understood similarly, for example, in terms of a value (i) being lower than or higher than a threshold or (ii) meeting or not meeting a threshold.

[0210] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except for combinations where at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiments. Protection extends to any novel feature or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novel feature or any novel combination of the steps of any method or process so disclosed.

[0211] Although certain embodiments have been described, these embodiments are presented only by way of example and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein may be embodied in various other forms. For example, although the housing has been shown as being mounted on the outer surface of the dressing, in some variations, the housing and / or the electronics of the activity monitoring device may be encapsulated in the dressing. In addition, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made. It will be appreciated by those skilled in the art that in some embodiments, the actual steps taken in the process shown or disclosed may be different from the steps shown in the accompanying drawings. According to an embodiment, some of the above steps may be removed and other steps may be added. For example, the actual steps or order of steps taken in the disclosed process may be different from those shown in the figure. According to an embodiment, some of the above steps may be removed and other steps may be added. For example, the various components shown in the figure may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, etc. may include logic circuits. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0212] Although the present disclosure includes certain embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages described herein. Therefore, the scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein, and may be limited by the claims set forth herein or claims set forth in the future.

[0213] Unless otherwise expressly stated, or otherwise understood in the context of use, conditional language (e.g., "may," "can," "might," or "could") is generally intended to express that certain embodiments include, while other embodiments do not include, certain features, elements, or steps. Therefore, such conditional language is generally not intended to imply that one or more embodiments require features, elements, or steps in any way, or that one or more embodiments must include logic for determining whether these features, elements, or steps are included or executed in any particular embodiment with or without user input or prompting. The terms "include," "comprise," "have," and the like are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, and the like. In addition, the term "or" is used in its inclusive sense (rather than in its exclusive sense) so that when used, for example, to connect a list of elements, the term "or" represents one, some, or all of the elements in the list. In addition, in addition to having its ordinary meaning, the term "each" used herein may represent any subset of a set of elements to which the term "each" is applied.

[0214] Unless expressly stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is understood in context as generally used to indicate that an item, term, etc. can be X, Y, or Z. Thus, such linking language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0215] Language of degree as used herein, such as the terms "approximately," "about," "substantially," and "substantially" as used herein, refers to a value, amount, or feature that is close to the stated value, amount, or feature and still performs the desired function or achieves the desired result. For example, the terms "approximately," "about," "substantially," and "substantially" may refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a specified amount. As another example, in certain embodiments, the terms "substantially parallel" and "substantially parallel" refer to a value, amount, or feature that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0216] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, and may be limited by the claims in this section or elsewhere in this specification or in the future. The language of the claims will be interpreted broadly based on the language employed in the claims, and not limited to examples described in this specification or during the prosecution of the application, which examples should be interpreted as non-exclusive.

Claims

1. An activity monitoring device for positioning on a user's body, the activity monitoring device comprising: a shell comprising a cover portion and a base portion connected to the cover portion, the cover portion and the base portion comprising an inner surface and an outer surface, the inner surface of the cover portion and the base portion forming an enclosed volume that is not in contact with any surface of a dressing, wherein at least one channel is formed in an outer surface of the base portion of the shell configured to face toward a user's body, the at least one channel being configured to provide a path for liquid to travel to a periphery of the shell; a circuit board assembly located within the enclosed volume formed by the inner surfaces of the cover and base portions of the housing, the circuit board assembly including a sensor configured to detect movement of the housing and a controller configured to monitor movement of the housing with the sensor; and The dressing includes an upper surface, a lower surface, and a fluid management layer, wherein the fluid management layer is configured to horizontally wick fluid as the fluid is absorbed upward through the layers of the dressing, the upper surface of the dressing is configured to adhere to an outer surface of the base portion of the shell that is configured to face the user's body, and the lower surface of the dressing is configured to contact and attach to the user's body when the shell is positioned on the user's body.

2. An activity monitoring device according to claim 1, wherein the dressing comprises a film dressing layer and a flexible film layer, and the film dressing layer is configured to fix the housing to the flexible film layer.

3. An activity monitoring device according to claim 2, wherein the film dressing layer is vacuum formed over the shell to hold the shell to the flexible film layer.

4. An activity monitoring device according to any one of claims 1-3, wherein the dressing further comprises a flexible film layer, wherein the flexible film layer at least partially defines an upper surface of the dressing, and wherein the flexible film layer is adhered to an outer surface of the base portion of the shell by an adhesive.

5. An activity monitoring device according to any one of claims 1-3, wherein the dressing comprises a contact layer at least partially defining a lower surface of the dressing, the contact layer being configured to be attached to the user.

6. An activity monitoring device according to claim 5, wherein the contact layer is perforated.

7. The activity monitoring device of claim 5, wherein the contact layer is moisture vapor permeable.

8. An activity monitoring device according to claim 5, wherein the dressing also includes a flexible film layer, wherein the contact layer is located below the flexible film layer at a position below the shell, and wherein the area of ​​the contact layer is at least as large as the area of ​​the outer surface of the base portion of the shell, and the contact layer is surrounded by the lower surface of the flexible film layer.

9. An activity monitoring device according to any one of claims 1-3, wherein the outer surface of the housing is flared outwardly near the outer surface of the base portion of the housing.

10. An activity monitoring device according to any one of claims 1-3, wherein the base portion of the shell includes an outer side wall extending from the base portion of the shell, and the outer side wall is configured to connect with an inner edge extending from an upper wall of the cover portion of the shell to form the enclosed volume.

11. The activity monitoring device according to any one of claims 1 to 3, wherein the dressing further comprises a flexible membrane layer and a frame delivery layer located above the flexible membrane layer.

12. The activity monitoring device of any one of claims 1-3, wherein the dressing further comprises a flexible membrane layer and a release handle located below the flexible membrane layer.

13. The activity monitoring device of any one of claims 1-3, wherein the dressing is quadrilobate.

14. The activity monitoring device of any one of claims 1-3, wherein the sensor is selected from the group consisting of a gyroscope, a magnetometer, an accelerometer, a barometer, a light sensor, and a temperature sensor.

15. The activity monitoring device of any one of claims 1-3, wherein the controller is configured to store the movement of the housing to a memory device and output the movement of the housing to an electronic device via a communication interface.

16. An activity monitoring device according to any one of claims 1-3, wherein the cover portion of the shell includes an inner edge extending from an upper wall of the cover portion, and wherein the base portion of the shell includes an outer side wall, and the inner edge and the outer side wall are adhered to each other to form the enclosed volume.

17. An activity monitoring device according to any one of claims 1 to 3, wherein: The fluid handling layer is selected from the group consisting of a wicking layer, an acquisition distribution layer, a foam layer, a spacer layer, and a transfer layer.

18. The activity monitoring device according to any one of claims 1 to 3, wherein: The dressing also includes an absorbent layer configured to overlap the fluid management layer.

19. The activity monitoring device according to any one of claims 1 to 3, wherein: No electrical components connected to the circuit board assembly are exposed on the outer surface of the base portion of the housing.

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