Phantom testing assembly for wearable biosensing devices

Abstract

A biosensing device testing assembly includes a phantom body structure, a physiological signal producing system, and a controller. The phantom body structure simulates a body structure of a living subject. The physiological signal producing system is configured to produce simulated physiological signals in the phantom body structure. The physiological signal producing system includes a pump unit configured to direct fluid through the phantom body structure to cause pulsations of the phantom body structure. The controller is configured to operate the pump unit to cause the pulsations of the phantom body structure.

Description

PHANTOM TESTING ASSEMBLY FOR WEARABLE BIOSENSING DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This nonprovisional application claims the benefit and priority, under 35 U.S.C. § 119(e) and any other applicable laws or statutes, to U.S. Provisional Application No. 63 / 571 ,082 filed on March 28, 2024, the entire disclosure of which is hereby expressly incorporated herein by reference.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] This invention was made with government support under Grant No. EEC- 1648451 awarded by the National Science Foundation. The government has certain rights in the invention.FIELD OF THE DISCLOSURE

[0003] The present disclosure relates generally to testing assemblies, and more specifically, to biosensing device testing assemblies.BACKGROUND

[0004] Wearable biosensing devices are becoming an important tool for modern healthcare. Whether in a clinic, a hospital, or at home, wearable biosensing devices may be utilized to provide accurate and important health care information.

[0005] However, the testing of such wearable biosensing devices to ensure accuracy and predictability is still under development. Moreover, characterization of such devices can require costly in vivo studies with humans and other animals to provide precision for the testing claims. Therefore, there exists a need to develop testing assemblies and methods to provide optimization of wearable biosensing devices.SUMMARY

[0006] The present disclosure may comprise one or more of the following features and combinations thereof.

[0007] According to an aspect of the present disclosure, a biosensing device testing assembly includes a phantom body structure, a physiological signal producing system, and a controller. The phantom body structure simulates a body structure of a living subject. The phantom body structure supports wearable biosensing devices thereon. The phantom body structure incorporates tunable compliance layers and variable vessel depths to accurately simulate anatomical variability across demographic profiles.

[0008] The physiological signal producing system is configured to produce simulated physiological signals in the phantom body structure to be detected by the wearable biosensing devices. The simulated physiological signals may include pulse waveforms, respiratory patterns, or other physiological phenomena to accurately mimic real-world conditions. The physiological signal producing system includes a pump unit configured to direct fluid through the phantom body structure to cause micromovements or pulsations of the phantom body structure. The controller is configured to operate the pump unit to cause the micro-movements or the pulsations of the phantom body structure via pumping of the fluid though the phantom body structure. In this way, the wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the micro-movements or the pulsations and / or identification of the simulated physiological signals.

[0009] In some embodiments, the pump unit includes a pump configured to direct the fluid through the phantom body structure and at least one pressure sensor in direct communication with the fluid that is configured to determine a fluid pressure of the fluid. In some embodiments, the physiological signal producing system includes a motor. The motor is configured to move the phantom body structure to cause macromovements of the phantom body structure. The motor is configured to generate the macro-movements simulating human activities such as walking, running, or arm motion to evaluate wearable biosensing device accuracy during dynamic conditions.

[0010] These and other features of the present disclosure will become more apparent from the following description of the illustrative embodiments.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Fig. 1 is a perspective view of a biosensing device testing assembly including an enclosure, a phantom body structure located within the enclosure andconfigured to simulate a body structure of a living subject, a physiological signal producing system located within the enclosure and configured to produce simulated physiological signals in the phantom body structure, and wearable biosensing devices supported on the phantom body structure and configured to detect the simulated physiological signals so that the wearable biosensing devices can be evaluated;

[0012] Fig. 2 is a top view of a portion of the biosensing device testing assembly of Fig. 1 showing that the phantom body structure is supported on a phantom mount and the wearable biosensing devices are supported on the phantom body structure and the phantom mount;

[0013] Fig. 3 is a block diagram of the assembly of Fig. 1 showing that the physiological signal producing system includes a motor configured to move a portion of the phantom mount to cause macro-movements of the phantom body structure and a pump unit configured to direct fluid through the phantom body structure to cause micro-movements or pulsations of the phantom body structure;

[0014] Fig. 4A is a diagrammatic view of the phantom body structure showing different layers of the phantom body structure;

[0015] Fig. 4B is a side view of the portion of the biosensing device testing assembly of Fig. 1 showing that the physiological signal producing system includes a temperature control unit supported on the phantom mount configured to cause temperature variations of the phantom body structure;

[0016] Fig. 5 is a detailed view of a portion of the pump unit showing that the pump unit includes a plurality of pipes that extend through the phantom mount to deliver the fluid to the phantom body structure to cause the micro-movements or the pulsations, and further showing that the pump unit includes pressure sensors in direct fluid communication with the fluid to determine a fluid pressure of the fluid;

[0017] Fig. 6 is a front view of the biosensing device testing assembly of Fig. 1 showing that the phantom body structure, the wearable biosensing devices, and the physiological signal producing system are located in the enclosure;

[0018] Fig. 7 is a back view of the biosensing device testing assembly of Fig. 1 showing that that pump unit includes a pump to direct the fluid through the plurality of pipes toward the phantom body structure and a reservoir that stores the fluid therein;

[0019] Fig. 8 is a detailed view of a flow pathway of the fluid through the biosensing device testing assembly showing that the flow pathway is a closed-loop flow pathway;

[0020] Fig. 9 is a block diagram of a control system of the biosensing device testing assembly of Fig. 1 showing that the simulated physiological signals include user-selected simulated cardiac performance characteristics, user-selected simulated skin temperatures, user-selected simulated kinetics, and user-selected simulated structure properties;

[0021] Fig. 10 is a graph showing exemplary user-selected simulated cardiac performance characteristics; and

[0022] Fig. 11 is a graph showing detected physiological signals by the wearable biosensing devices caused by the user-selected simulated cardiac performance characteristics of Fig. 10.DETAILED DESCRIPTION OF THE DRAWINGS

[0023] For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to a number of illustrative embodiments illustrated in the drawings and specific language will be used to describe the same.

[0024] The present disclosure provides a biosensing device testing assembly 10 that is capable of testing one or more wearable biosensing devices 12 for accuracy and development purposes. The testing assembly 10 allows for the design parameters of the wearable biosensing devices 12 to be tested and optimized. The wearable biosensing devices 12 may comprise watches, straps, patches, earbuds, rings, or any other suitable wearable biosensing device 12. The testing assembly 10 is adaptable to evaluate devices 12 designed for various anatomical regions, including, but not limited to, the arm, wrist, chest, neck, forehead, and / or torso.

[0025] The biosensing device testing assembly 10 includes at least one phantom extremity 14 and a physiological signal producing system 16, as shown in Fig. 1 . The at least one phantom extremity 14 may be referred to as a phantom body structure 14. The at least one phantom body structure 14 simulates an extremity, a body structure, or a region of a living subject, such as, for example, an arm, a wrist, a finger, a leg, a toe, an ankle, an ear, an appendage, a hand, a foot, a head, or any other suitable body structure or anatomical region. The living subject may be a humanor an animal. The phantom body structure 14 allows for continuous in vitro monitoring and testing of the wearable biosensing devices 12 by mimicking the anatomy and physiology of the living subject thereby minimizing the need for extensive in vivo studies. The physiological signal producing system 16 is configured to produce simulated physiological signals in the phantom body structure 14 to mimic physiological signals of the living subject. The simulated physiological signals are detected or sensed by the wearable biosensing devices 12 as detected physiological signals. The simulated physiological signals and the detected physiological signals may be compared to optimize the wearable biosensing devices 12.

[0026] The phantom body structure 14 has mechanical properties and optical properties that simulate the body structure of the living subject. For example, the stiffness and / or compliance of the phantom body structure 14 may be adjusted to simulate different mechanical properties. Variability of the compliance of the phantom body structure 14 allows for simulation of different Body Mass Indexes. As another example, the optical properties may be adjusted to mimic different skin tones or blood oxygenation levels.

[0027] In exemplary embodiments, the phantom body structure 14 includes an exterior layer 18 and at least one vessel 20, as shown in Figs. 3 and 4A. The exterior layer 18 interfaces with the wearable biosensing devices 12. The at least one vessel 20 is arranged under the exterior layer 18. In some embodiments, the phantom body structure 14 further includes an interior layer 22 arranged under the exterior layer 18, as shown in Fig. 4A.

[0028] The exterior layer 18 simulates an epidermis skin layer of the living subject. The exterior layer 18 includes a free outer surface 180 shaped to support and contact the wearable biosensing devices 12 and an inner surface 181 opposite the free outer surface 180, as shown in Fig. 4A. The interior layer 22 simulates a dermis skin layer of the living subject. The interior layer 22 extends between an outer surface 220 and an inner surface 22I opposite the outer surface 220, as shown in Fig. 4A. The outer surface 220 of the interior layer 22 interfaces with the inner surface 181 of the exterior layer 18. The at least one vessel 20 is arranged under the inner surface 181 of the exterior layer 18. In some embodiments, the at least one vessel 20 extends through the interior layer 22 between the outer surface 220 and the inner surface 22I thereof.

[0029] The exterior layer 18 has a first compliance value, and the interior layer 22 has a second compliance value. In some embodiments, the first and second compliance values are different from one another. In some embodiments, the first compliance value is greater than the second compliance value. The range of compliance values is adjustable to mimic varying skin conditions, including healthy, scarred, or aging skin.

[0030] The at least one vessel 20 is shaped to define a passageway 20P extending therethrough, as shown in Fig. 5. The passageway 20P receives fluid therein that simulates blood. The fluid is carried through the passageway 20P along the phantom body structure 14 for detection by the wearable biosensing devices 12. The shape, size, depth, and location of the at least one vessel 20 simulates a typical blood vessel (i.e., artery, capillary, vein, arteriole, venule).

[0031] In some embodiments, the at least one vessel 20 simulates a single artery. In some embodiments, the at least one vessel 20 simulates an arteriole network with multiple arteries. In some embodiments, the at least one vessel 20 simulates a capillary network. The compliance range of the at least one vessel 20 is tunable to reflect variations seen in different arterial conditions, such as atherosclerosis or hypertension.

[0032] The at least one vessel 20 has a third compliance value. In some embodiments, the third compliance value is less than the first compliance value. In some embodiments, the third compliance value is greater than the second compliance value.

[0033] In some embodiments, the phantom body structure 14 further includes a sub-interior layer 21 and a muscle layer 23, as shown in Fig. 4A. The sub-interior layer 21 simulates a hypodermis skin layer of the living subject. The sub-interior layer 21 includes an outer surface 210 that interfaces with the inner surface 22I of the interior layer 22 and an inner surface 211 opposite the outer surface 210, as shown in Fig. 4A.

[0034] The muscle layer 23 simulates a muscle of the living subject. The muscle layer 23 extends between an outer surface 230 and an inner surface 23I opposite the outer surface 230, as shown in Fig. 4A. The outer surface 230 of the muscle layer 23 interfaces with the inner surface 211 of the sub-interior layer 21 .

[0035] Though shown and described as having five layers, the phantom body structure 14 may have any number of layers or components. Further, the layers orcomponents may have any thickness that appropriately replicates an array of physical anatomies.

[0036] As shown in Fig. 4A, the exterior layer 18, the interior layer 22, the at least one vessel 20, the sub-interior layer 21 , and the muscle layer 23 each have different thicknesses. For example, the exterior layer 18 is thinner than the interior layer 22, the at least one vessel 20, the sub-interior layer 21 , and the muscle layer 23. The exterior layer 18 may have a thickness of about 0.1 millimeters to about 1 millimeter. The interior layer 22 may have a thickness of about 1 millimeter. The at least one vessel 20 may have a thickness of about 0.6 millimeters to about 1 millimeter. The sub-interior layer 21 may have a thickness of about 1 millimeter to about 5 millimeters. However, these dimensions are exemplary and may be adjusted as needed to mimic various anatomical structures, tissue characteristics, or specific testing conditions. Variations in layer thicknesses may be employed to simulate differences in body composition, age, or health conditions.

[0037] The exterior layer 18, the interior layer 22, the at least one vessel 20, the sub-interior layer 21 , and the muscle layer 23 each have different compliances. For example, the exterior layer 18 may have a compliance of about 1 MPa to about 2 MPa. The interior layer 22 may have a compliance of about 45 kPa. The sub-interior layer 21 may have a compliance of about 2 kPa. The at least one vessel 20 may have a compliance of about 0.2 MPa to about 2 MPa. However, these compliance values are exemplary and may be adjusted to reflect a wide range of mechanical properties found in biological tissues. Variations in compliance may be implemented to simulate different anatomical conditions, such as variations in skin elasticity, muscle tone, or vascular stiffness, ensuring accurate device 12 evaluation under diverse physiological scenarios.

[0038] In some embodiments, the phantom body structure 14 comprises any suitable material or combination of materials having appropriate mechanical properties and optical properties to simulate the body structure of the living subject. In some embodiments, each of the exterior layer 18, the interior layer 22, the at least one vessel 20, the sub-interior layer 21 , and the muscle layer 23 comprises platinum- catalyzed silicon rubber doped with calcium carbonate and silicone oil. Additional material combinations may be used, such as flexible polymers, elastomers, or composite materials, to expand the range of mechanical and optical propertiesachievable. These materials can be selected to mimic various anatomical conditions across demographics, age groups, and health profiles.

[0039] In some embodiments, the platinum-catalyzed silicon rubber can be resin, polydimethylsiloxane (PDMS), silicone, gelatin, agar, and 3D printed materials. To form each layer, the materials of the platinum-catalyzed silicon rubber are combined, and then the calcium carbonate and the silicone oil are added to the components of the platinum-catalyzed silicon rubber. Other additives, such as absorbers and scatterers, may be added as well, as described in more detail below. The mixture is then mixed and poured into a mold. The mixture is then degassed and cured in the mold. A rod or a pre-made vessel 20 may be inserted into the interior layer 22 during the molding process. Alternative manufacturing methods, including 3D printing, casting, or layer-by-layer assembly, may also be employed to achieve complex anatomical structures with precision.

[0040] In some embodiments, each of the exterior layer 18, the interior layer 22, the at least one vessel 20, the sub-interior layer 21 , and the muscle layer 23 includes additives that alter the optical properties of the respective layer. For example, the additives may include absorbers, such as, but not limited to, dyes, synthetic melanin, or any other absorbers. The absorbers may include oil-based absorbers, silicon-based absorbers, food grade absorbers, acrylics, inks, paints, etc. As another example, the additives may include scatterers, such as, but not limited to, metallic powders, microspheres, intralipids, etc. These additives may be adjusted in concentration and distribution to create optical properties that mimic varied skin conditions, including pigmentation disorders, scar tissue, and skin affected by aging or medical conditions.

[0041] In some embodiments, the exterior layer 18 is characterized by light absorption and reduced scattering coefficients equivalent to absorption and reduced scattering coefficients of skin tones within or outside of levels 1-10 on the Monk Skin Tone Scale. In this way, the exterior layer 18 can have different optical properties that simulate different skin tones. The optical characteristics may also be modified to simulate varied blood oxygenation levels, melanin content, and environmental lighting effects to improve device 12 robustness in diverse conditions.

[0042] As shown in Fig. 2, the testing assembly 10 further includes a phantom mount 24. The phantom mount 24 supports the phantom body structure 14 thereon.For example, as shown in Figs. 2 and 4B, the phantom body structure 14 is positioned on top of the phantom mount 24.

[0043] The wearable biosensing devices 12 are supported on the phantom body structure 14 and the phantom mount 24, as shown in Figs. 2 and 4B. For example, in embodiments in which the wearable biosensing devices 12 are watches and the phantom body structure 14 is a wrist or an arm, the wearable biosensing devices 12 extend around the phantom body structure 14 and the phantom mount 24. The wearable biosensing devices 12 each include a biosensor that contacts or engages the phantom body structure 14 (i.e., the outer surface 180 of the exterior layer 18). The biosensor senses or detects the detected physiological signals. A contact pressure created between the wearable biosensing devices 12 and the phantom body structure 14 may be altered and adjusted, as needed. The contact pressure control may be automated or manually adjusted to replicate varied conditions such as tight straps, loose-fitting sensors, or variable skin tension.

[0044] The phantom mount 24 illustratively includes a stationary portion 26 and a moveable portion 28, as shown in Fig. 4B. The stationary portion 26 remains fixed, while the moveable portion 28 is moveable relative to the stationary portion 26. The phantom body structure 14 is coupled to and / or supported on the moveable portion 28, as shown in Fig. 4B. In this way, the phantom body structure 14 (and the wearable biosensing devices 12) move with the moveable portion 28. In some embodiments, the moveable portion 28 is free to move along six axes. In some embodiments, the moveable portion 28 is free to move along five axes. In some embodiments, the moveable portion 28 is free to move along four axes. In some embodiments, the moveable portion 28 is free to move along three axes. In some embodiments, the moveable portion 28 is free to move along two axes. In some embodiments, the moveable portion 28 is free to move along one axis. In some embodiments, the moveable portion 28 pivots relative to the stationary portion 26. This flexibility in movement allows the testing system 10 to replicate complex biomechanical scenarios, such as joint motion, muscle flexion, and dynamic skin deformation.

[0045] The physiological signal producing system 16 is configured to produce the simulated physiological signals in the phantom body structure 14 so that the simulated physiological signals may be detected as the detected physiological signals by the wearable biosensing devices 12. The simulated physiological signals includeuser-selected simulated kinetics, user-selected simulated cardiac performance characteristics, user-selected simulated skin temperatures, user-selected simulated structure properties, user-selected simulated environmental temperatures, and varied peripheral vascular conditions, among other simulated features.

[0046] The physiological signal producing system 16 includes at least one motor 30, a pump unit 32, and a temperature control unit 34, as shown in Figs. 3 and 4B. The motor 30 is configured to move the moveable portion 28 of the phantom mount 24 relative to the stationary portion 26. The pump unit 32 is configured to direct the fluid through the phantom body structure 14. The temperature control unit 34 is configured to adjust a temperature of the phantom body structure 14. The temperature control unit 34 may use localized heating or cooling elements to mimic regional thermal variations caused by blood flow changes, inflammation, or environmental exposure.

[0047] The motor 30 is configured to drive movement of the moveable portion 28 of the phantom mount 24 relative to the stationary portion 26 of the phantom mount 24. The motor 30 is coupled to the moveable portion 28, as shown in Fig. 4B. In some embodiments, the motor 30 may be a servo motor. The motor 30 causes macromovement of the phantom body structure 14 with preselected motion patterns based on the user-selected simulated kinetics. The wearable biosensing devices 12 supported on the phantom body structure 14 can be evaluated as to the detection of the macro-movements and / or identification of the user-selected simulated kinetics.

[0048] The preselected motion patterns simulate macro-movement of the living subject. Macro-movement and the user-selected simulated kinetics include daily human kinetics, such as, but not limited to, running, walking, cycling, swimming, brushing teeth, etc. The user-selected simulated kinetics may also include conditions related to health and illness, such as a sudden fall. Macro-movement includes movements that are detectable and readable by an accelerometer, a gyroscope, and / or an inertial measurement unit (IMU). The macro-movement of the phantom body structure 14 is detected and / or sensed by the wearable biosensing devices 12.

[0049] The pump unit 32 is in fluid communication with the phantom body structure 14, as shown in Fig. 3. The pump unit 32 includes a at least one pump 36 and at least one pressure sensor 38, as shown in Figs. 3, 5, and 7. The pump 36 directs the fluid through the phantom body structure 14. More specifically, the pump 36 directs the fluid through the at least one vessel 20. The at least one pressure sensor38 detects and / or senses a fluid pressure of the fluid flowing through the at least one vessel 20. The at least one pressure sensor 38 is in direct fluid communication with the fluid. In some embodiments, the pump 36 may be an impeller pump, a centrifugal pump, a diaphragm pump, a gear pump, or any other suitable type of pump.

[0050] The pump unit 32 further includes at least one reservoir 40, a plurality of pipes 42, and / or a plurality of valves 44, as shown in Figs. 3, 5, and 8. The at least one reservoir 40 stores the fluid therein. The plurality of pipes 42 interconnect the at least one reservoir 40, the at least one pump 36, and the phantom body structure 14. The plurality of valves 44 control the flow of the fluid through the pump unit 32.

[0051] As an example, the fluid may flow from the at least one reservoir 40 and into the plurality of pipes 42 due to operation of the at least one pump 36. The plurality of pipes 42 is fluidly coupled to the at least one vessel 20 of the phantom body structure 14 so that the fluid is then directed through the at least one vessel 20, as shown in Fig. 8. As shown in Fig. 5, the plurality of pipes 42 includes a first mount pipe 46 and a second mount pipe 48 spaced apart from the first mount pipe 46. The first mount pipe 46 is coupled to a first end of the at least one vessel 20. The first mount pipe 46 receives the fluid from the at least one reservoir 40 and directs the fluid into the first end of the at least one vessel 20. The second mount pipe 48 is coupled to a second end of the at least one vessel 20 opposite the first end. The second mount pipe 48 receives the fluid from the at least one vessel 20 to direct the fluid back to the at least one reservoir 40. In this way, the pump unit 32 forms a closed-loop flow pathway so that the fluid is reused.

[0052] The first mount pipe 46 and the second mount pipe 48 are located in the phantom mount 24, as suggested in Figs. 4B and 5. The first mount pipe 46 has an angled portion 46A and a horizontal portion 46B coupled to the angled portion 46A, as shown in Fig. 5. The horizontal portion 46B is coupled with the first end of the at least one vessel 20. The second mount pipe 48 includes a first horizontal portion 48A, a second horizontal portion 48B spaced apart vertically from the first horizontal portion 48A, and a curved portion 48C extending between and interconnecting the first horizontal portion 48A and the second horizontal portion 48B. The first horizontal portion 48A is coupled with the second end of the at least one vessel 20.

[0053] The fluid flows through the horizontal portion 46B of the first mount pipe 46, through the at least one vessel 20, and through the first horizontal portion 48A ofthe second mount pipe 48 in a first direction, as shown in Fig. 5. From the first horizontal portion 48A of the second mount pipe 48, the fluid turns downwardly in the curved portion 48C to then flow in a second direction opposite the first direction through the second horizontal portion 48B of the second mount pipe 48. Thus, the fluid flows through the plurality of pipes 42 within the phantom mount 24 in both the first and second directions to enter and exit the at least one vessel 20.

[0054] As shown in Fig. 5, in some embodiments, the at least one pressure sensor 38 includes a first pressure sensor 38A arranged on the first mount pipe 46 upstream of the at least one vessel 20 and a second pressure sensor 38B arranged on the second mount pipe 48 downstream of the at least one vessel 20. In some embodiments, the first pressure sensor 38A is arranged on the angled portion 46A of the first mount pipe 46. In some embodiments, the second pressure sensor 38B is arranged on the first horizontal portion 48A of the second mount pipe 48. It will be understood that other arrangements and locations of the at least one pressure sensor 38 are contemplated.

[0055] In some embodiments, the plurality of valves 44 includes a main valve 44A, a phantom valve 44B, and a bypass valve 44C, as shown in Fig. 8. The main valve 44A is located between the pump 36 and the phantom valve 44B / the bypass valve 44C. The main valve 44A controls the flow of the fluid exiting the at least one reservoir 40. The phantom valve 44B is located between the main valve 44A and the phantom body structure 14 to control the flow of the fluid into the at least one vessel 20. The bypass valve 44C is located between the main valve 44A and the at least one reservoir 40 to allow for some or all of the fluid to bypass the phantom body structure 14. In some embodiments, the phantom valve 44B and the bypass valve 44C may be flow-adjustment needle valves.

[0056] The pump unit 32 causes micro-movement or pulsations of the phantom body structure 14 with the user-selected simulated cardiac performance characteristics by directing the fluid through the at least one vessel 20 to simulate micro-movement or pulsations of the living subject. In other words, the pump unit 32 may cause fluid pulsations within the phantom body structure 14. The fluid may be pumped at preselected frequencies, amplitudes, and / or fluid pressures for example, though the phantom body structure 14 based on the user-selected simulated cardiac performance characteristics. The wearable biosensing devices 12 supported on the phantom bodystructure 14 can be evaluated as to detection of the micro-movements and / or identification of the simulated cardiac performance characteristics.

[0057] Micro-movement and / or pulsations include movement caused by breathing, heart palpitations, etc. Micro-movement or movement from pulsations include movements that are not detectable or readable by an accelerometer, a gyroscope, and / or an inertial measurement unit (IMU).

[0058] The user-selected simulated cardiac performance characteristics include any one of or any combination of heart rate variability, wave morphology, blood pressure, heart rate, and / or respiration rate. As an example, a first preselected frequency may be associated with an increase in heart rate, and a second preselected frequency may be associated with a decrease in heart rate. The first preselected frequency may be greater than the second preselected frequency. As another example, a first preselected amplitude may be associated with an increase in heart rate, and a second preselected amplitude may be associated with a decrease in heart rate. The first preselected amplitude may be less than the second preselected amplitude. As another example, a first preselected fluid pressure may be associated with an increase in blood pressure, and a second preselected fluid pressure may be associated with a decrease in blood pressure. The first preselected fluid pressure may be greater than the second preselected fluid pressure.

[0059] The pump unit 32 may be used to simulate different respiratory motions. For example, the pump unit 32 may simulate baseline wander, frequency modulation, and / or amplitude modulation. As one breathes in, heart rate generally increases (i.e., an increase in frequency modulation) to bring more oxygen into the blood, and as one breathes out, heart rate generally decreases (i.e., decrease in frequency modulation). Thus, the user-selected simulated cardiac performance characteristics may be simulated using the pump unit 32. The user-selected simulated cardiac performance characteristics may also include biomarkers related to health and illness.

[0060] The temperature control unit 34 is configured to adjust a temperature of the phantom body structure 14. The temperature control unit 34 causes temperature variation of the phantom body structure 14 with the user-selected simulated skin temperatures to simulate temperature variation of the living subject. The temperature control unit 34 also causes temperature variation of an enclosure 62 with the user- selected simulated environmental temperatures to simulate different environmentaltemperatures. The wearable biosensing devices 12 supported on the phantom body structure 14 can be evaluated as to detection of the temperature variations and / or identification of the user-selected simulated skin temperatures and the user-selected simulated environmental temperatures. The user-selected simulated skin temperatures may be associated with the onset of various illnesses, conditions, or diseases, such as, but not limited to, a reduced peripheral blood flow, an ovulatory cycle, and / or an increase in metabolic efficiency due to exercise, along with any additional illnesses, conditions, or diseases.

[0061] The temperature control unit 34 includes a heater / cooler 50 and at least one temperature sensor 52, as shown in Figs. 2, 3, and 4B. The heater / cooler 50 is arranged underneath the phantom body structure 14 to adjust the temperature of the phantom body structure 14. In some embodiments, the heater / cooler 50 is located underneath the inner surface 23I of the muscle layer 23 of the phantom body structure 14. In some embodiments, the heater / cooler 50 is coupled to the moveable portion 28 of the phantom mount 24. In some embodiments, the heater / cooler 50 is located in the enclosure 62, as shown in Fig. 1 , to control for environmental temperature changes. In some embodiments, the heater / cooler 50 is a silicone heater. The at least one temperature sensor 52 is configured to determine the temperature of the phantom body structure 14. In some embodiments, the at least one temperature sensor 52 is located on the outer surface 180 of the exterior layer 18. In some embodiments, the at least one temperature sensor 52 is located on the heater / cooler 50 to determine the temperature of the heater / cooler 50. In some embodiments, the at least one temperature sensor 52 includes two temperature sensors 52, with one temperature sensor being located on the outer surface 180 of the exterior layer 18 and the other temperature sensor being located on the heater / cooler 50. In some embodiments, the temperature control unit 34 includes two heaters / coolers 50 with one heater / cooler 50 arranged underneath the phantom body structure 14 to adjust the temperature of the phantom body structure 14 and another heater / cooler 50 located in the enclosure 62 and configured to adjust the temperature of the enclosure 62.

[0062] The biosensing device testing assembly further includes a controller 54, as shown in Fig. 3. The controller 54 is in communication with the physiological signal producing system 16. In some embodiments, the controller 54 is in communication with the motor 30, the plurality of valves 44 of the pump unit 32, the at least one pump 36 ofthe pump unit 32, the at least one pressure sensor 38 of the pump unit 32, the heater / cooler 50 of the temperature control unit 34, and / or the at least one temperature sensor 52 of the temperature control unit 34. The controller 54 operates the motor 30, the plurality of valves 44, the at least one pump 36, and / or the heater / cooler 50.

[0063] The controller 54 includes a memory 56, a processor 58, and a user interface 60, as shown in Fig. 3. The user interface 60 allows a user to choose, adjust, or determine the user-selected simulated kinetics, the user-selected simulated skin temperatures, the simulated cardiac performance characteristics, the user-selected simulated environmental temperatures, and the user-selected simulated structure properties of the phantom body structure 14. The user-selected simulated kinetics may include different activities or motions. The user-selected simulated cardiac performance characteristics may include wave morphology, respiration rate, fluid pressure, heart rate, heart rate variability, blood pressure, conditions, diseases, and / or illnesses. The user-selected simulated skin temperatures may include different temperatures, conditions, diseases, and / or illnesses. The user-selected simulated structure properties may include skin tones, blood oxygenation levels, conditions, diseases, and / or illnesses.

[0064] Based on the user-selected simulated kinetics, the controller 54 operates the motor 30 to cause the macro-movements of the phantom body structure 14 with the preselected motion patterns. For example, the user may choose running at a 6.0 MPH speed as the user-selected simulated kinetics. The controller 54 then operates the motor 30 with the preselected motion pattern related to the running at the 6.0 MPH speed.

[0065] Based on the user-selected simulated cardiac performance characteristics, the controller 54 operates the pump unit 32 to adjust the pumping of the fluid through the phantom body structure 14. For example, the controller 54 may operate the pump unit 32 to adjust the pumping of the fluid at preselected frequencies, amplitudes, fluid pressures, etc. based on the user-selected simulated cardiac performance characteristics.

[0066] Based on the user-selected simulated skin temperatures, the controller 54 operates the heater / cooler 50 to adjust the temperature of the phantom body structure 14 at the preselected temperatures. For example, the user may choose high fever (for example, 101 degrees Fahrenheit) as the user-selected simulated skintemperatures. The controller 54 then operates the heater / cooler 50 with the preselected temperature related to the high fever. The heater / cooler 50 may increase or decrease a temperature of the phantom body structure 14.

[0067] Based on the user-selected simulated environmental temperatures, the controller 54 operates the heater / cooler 50 to adjust the temperature of the interior space 64 of the enclosure 62 at preselected temperatures. For example, the user may choose a hot environment (for example, 95 degrees Fahrenheit) as the user-selected simulated environmental temperatures. The controller 54 then operates the heater / cooler 50 with the preselected temperature related to the hot environment. The heater / cooler 50 may increase or decrease a temperature of the interior space 64.

[0068] The user-selected simulated kinetics, the user-selected simulated cardiac performance, the user-selected simulated skin temperature, the user-selected simulated environmental temperatures, and the user-selected simulated structure properties are stored in the memory 56 of the controller 54. Based on the input from the user, the processor 58, using instruction stored in the memory 56, operates the motor 30, the plurality of valves 44, the at least one pump 36, and the heater / cooler 50 based on the user selection.

[0069] The controller 54 stores the user selection (i.e. , the particular user- selected simulated kinetics, the particular user-selected simulated cardiac performance, the particular user-selected simulated skin temperature, the particular user-selected simulated environmental temperature, and the particular user-selected simulated structure properties) in the memory 56 of the controller 54. The controller 54 receives temperature data from the at least one temperature sensor 52 and fluid pressure data from the at least one pressure sensor 38. The temperature data and the fluid pressure data are stored in the memory 56.

[0070] In some embodiments, the controller 54 is in communication with the wearable biosensing devices 12 to receive detected physiological signal data therefrom, as suggested in Fig. 3. The controller 54 stores the detected physiological signal data in the memory 56. The processor 58 may compare the particular user- selected simulated kinetics, the particular user-selected simulated cardiac performance, the particular user-selected simulated environmental temperature, and / or the particular user-selected simulated skin temperature with the detected physiological signal data from the wearable biosensing devices 12.

[0071] Based on the comparison made by the processor 58, the wearable biosensing devices 12 supported on the phantom body structure 14 can be evaluated as to detection of the pulsations, the micro-movements, the macro-movements, and the temperature variability. Further, based on the comparison made by the processor 58, the wearable biosensing devices 12 supported on the phantom body structure 14 can be evaluated as to identification of the simulated cardiac performance characteristics, the simulated kinetics, the simulated environmental temperatures, and / or the simulated skin temperatures.

[0072] In some embodiments, the user interface 60 displays the particular user- selected simulated kinetics, the particular user-selected simulated cardiac performance characteristics, the particular user-selected simulated environmental temperatures, and / or the particular user-selected simulated skin temperatures with the detected physiological signal data from the wearable biosensing devices 12. In this way, the user can perform a visual comparison and / or an analysis of the data. As shown in Figs. 10 and 11 , the pump unit 32 inputs (Fig. 10) may be compared to the detected physiological signals of the wearable biosensing devices 12 (Fig. 11).

[0073] The comparison of the data may be used to test, analyze, and optimize the wearable biosensing devices 12. The biosensing device testing assembly 10 may minimize studies on living subjects. Further, the biosensing device testing assembly 10 allows for testing parameters that may not be possible using living subjects. For example, a large enough sample of living subjects having a particular disease may be difficult to find for testing of the wearable biosensing devices 12 on detection and / or identification of that disease. The biosensing device testing assembly 10, thus, allows for simulating study parameters that may be difficult to perform on living subjects.

[0074] In some embodiments, the biosensing device testing assembly 10 includes an enclosure 62, as shown in Fig. 1 . The enclosure 62 houses the components of the biosensing device testing assembly 10. For example, the phantom body structure 14 and the physiological signal producing system 16 are located in an interior space 64 of the enclosure 62. As an example, the enclosure 62 may be about 34 inches in length, 22 inches in height, and 27 inches in width.

[0075] In some embodiments, the biosensing device testing assembly 10 may include drip trays 66 under each phantom mount 24 to maintain cleanliness within theenclosure 62, a perforated flooring 68 on a bottom surface of the enclosure 62, and / or a camera 70 mounted in the enclosure 62.

[0076] As shown in Fig. 1 , one phantom body structure 14 may support multiple wearable biosensing devices 12 thereon. For example, one phantom body structure 14 may support three wearable biosensing devices 12 thereon. One phantom body structure 14 may support any number of wearable biosensing devices 12 thereon, such as, but not limited to, one to twenty wearable biosensing devices 12.

[0077] As shown in Fig. 1 , the biosensing device testing assembly 10 may include two phantom body structures 14 each supporting wearable biosensing devices 12 thereon. In some embodiments, the two phantom body structures 14 may simulate a right extremity and a left extremity of the living subject. In some embodiments, the two phantom body structures 14 may simulate structures unrelated to one another such that multiple tests may be run at the same time.

[0078] In such an embodiment, the biosensing device testing assembly 10 may include one phantom mount 24 per phantom body structure 14, one motor 30 per phantom body structure 14, one pump 36 per phantom body structure 14, two pressure sensors 38 per phantom body structure 14, one reservoir 40 per phantom body structure 14, one heater / cooler 50 per phantom body structure 14, and at least one temperature sensor 52 per phantom body structure 14. In other embodiments, the biosensing device testing assembly 10 may include one pump 36, two pressure sensors 38, and one reservoir 40 that are in fluid communication with both phantom body structures 14 (i.e., one closed loop flow pathway including both phantom body structures 14).

[0079] To increase testing capabilities and develop a method to optimize the design parameters of wearable biosensing devices 12 (e.g. watch, chest strap, patch, earbuds, rings) utilized with fitness and medical devices, the biosensing device testing assembly 10 incorporates phantom body structures 14, the pump 36, and motion that allows continuous in vitro monitoring, mimicking human anatomy and physiology minimizing the need for extensive in vivo studies. The phantom body structure 14 (e.g. tissue and blood mimicking material) can be made with variations in the tissue form factor (e.g. wrist, finger, ear), mechanical properties (e.g. stiffness and compliance), and optical properties (e.g. mimicking different skin tones or simulated blood oxygenations). For example, the phantom body structure 14 simulates human skin withtunable compliance to simulate variability with Body Mass Index. The testing assembly 10 has the pump 36 that generates features that stimulate the cardiac cycle, including cardiac cycle rate variability, waveform morphology, micromotions like respiration rate, and biomarkers related to health and illness that can be programmed into the testing assembly 10.

[0080] The testing assembly 10 also has the capability of moving the phantom body structure 14 to simulate macro-motion such as daily human kinetics, including, but not limited to, typing, walking, running, and brushing teeth. Specifically, the testing assembly 10 can achieve up to 6-axis motion and can be programmed to use 2, 3, 4, or 5 axes if the application is needed. The testing assembly 10 can be used to develop human contextual awareness, which can help guide more accurate fitness and medical monitoring, along with human-guided control for nontactile control of external devices.

[0081] In addition to the cardiac features, the testing assembly 10 provides temperature variations to simulate body temperature changes. It can be varied to simulate the onset of disease, reduced peripheral blood flow, ovulatory cycle, and an increase in metabolic efficiency due to exercise, along with any additional scenarios.

[0082] The overall purpose of simulating the form factor, mechanical and optical properties, pulse frequency and wave shape, motion, and temperature is to understand how wearable biosensing devices 12 perform under various conditions and how noise signal artifacts affect signal quality. This will not only help characterize the wearable biosensing devices 12, minimizing the amount of in vivo studies required, but can also help drive the hardware design and software algorithms of the wearable biosensing devices 12 for optimal performance.

[0083] The controller 54 allows the user to select the wave morphology, fluid pressure, heart rate, heart rate variability, temperature, and activity / motion control settings. The testing assembly 10 may be used to create more robust wearable biosensing devices 12. With increased accuracy, wearable biosensing devices 12 may be able to become medical devices due to FDA compliance. In vitro testing allows for high cycle testing of wearable biosensing devices 12 and fast iteration.

[0084] The following numbered clauses include embodiments that are contemplated and non-limiting:

[0085] Clause 1 . A biosensing device testing assembly comprising a phantom body structure having mechanical properties and optical properties to simulate a bodystructure of a living subject, and a physiological signal producing system configured to produce simulated physiological signals in the phantom body structure, the physiological signal producing system including a motor configured to move the phantom body structure to cause macro-movements of the phantom body structure and a pump unit configured to direct fluid through the phantom body structure to cause pulsations of the phantom body structure, the pulsations being undetectable on an inertial measurement unit.

[0086] Clause 2. The biosensing device testing assembly of clause 1 , any other suitable clause, or any other suitable combination of clauses, wherein the pump unit includes a pump configured to direct the fluid through the phantom body structure and at least one pressure sensor in direct fluid communication with the fluid that is configured to determine a fluid pressure of the fluid.

[0087] Clause 3. The biosensing device testing assembly of clause 1 , any other suitable clause, or any other suitable combination of clauses, wherein the simulated physiological signals include user-selected simulated skin temperatures, and wherein the physiological signal producing system further includes a temperature control unit configured to adjust a temperature of the phantom body structure.

[0088] Clause 4. The biosensing device testing assembly of clause 3, any other suitable clause, or any other suitable combination of clauses, further comprising a controller configured to operate the temperature control unit to adjust the temperature of the phantom body structure at preselected temperatures based on the user-selected simulated skin temperatures so that wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the preselected temperatures and / or identification of the user-selected simulated skin temperatures.

[0089] Clause 5. The biosensing device testing assembly of clause 3, any other suitable clause, or any other suitable combination of clauses, wherein the temperature control unit includes a heater arranged underneath the phantom body structure to adjust the temperature of the phantom body structure and at least one temperature sensor configured to determine the temperature of the phantom body structure.

[0090] Clause 6. The biosensing device testing assembly of clause 1 , any other suitable clause, or any other suitable combination of clauses, wherein the simulated physiological signals include user-selected simulated kinetics, and wherein the biosensing device testing assembly further comprises a controller configured tooperate the motor to cause the macro-movements of the phantom body structure with preselected motion patterns based on the user-selected simulated kinetics so that wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the macro-movements and / or identification of the user- selected simulated kinetics.

[0091] Clause 7. The biosensing device testing assembly of clause 6, any other suitable clause, or any other suitable combination of clauses, wherein the user- selected simulated kinetics include running, walking, cycling, and / or swimming.

[0092] Clause 8. The biosensing device testing assembly of clause 6, any other suitable clause, or any other suitable combination of clauses, wherein the macromovements are detectable on the inertial measurement unit.

[0093] Clause 9. The biosensing device testing assembly of clause 6, any other suitable clause, or any other suitable combination of clauses, wherein the simulated physiological signals include user-selected simulated cardiac performance characteristics, and wherein the controller is configured to operate the pump unit to cause the pulsations of the phantom body structure via pumping of the fluid at preselected frequencies and / or amplitudes though the phantom body structure based on the user-selected simulated cardiac performance characteristics so that the wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the pulsations and / or identification of the user-selected simulated cardiac performance characteristics.

[0094] Clause 10. The biosensing device testing assembly of clause 9, any other suitable clause, or any other suitable combination of clauses, wherein the user- selected simulated cardiac performance characteristics include at least two of heart rate variability, wave morphology, blood pressure, heart rate, and / or respiration rate.

[0095] Clause 11 . The biosensing device testing assembly of clause 9, any other suitable clause, or any other suitable combination of clauses, wherein a first preselected frequency is associated with an increase in heart rate and a second preselected frequency is associated with a decrease in heart rate, and wherein the first preselected frequency is greater than the second preselected frequency.

[0096] Clause 12. The biosensing device testing assembly of clause 9, any other suitable clause, or any other suitable combination of clauses, wherein the controller is in communication with the wearable biosensing devices, and wherein thecontroller is configured to compare the user-selected simulated cardiac performance characteristics with detected physiological signals by the wearable biosensing devices to optimize performance of the wearable biosensing devices.

[0097] Clause 13. The biosensing device testing assembly of clause 1 , any other suitable clause, or any other suitable combination of clauses, further comprising an enclosure formed to define an interior space therein, the phantom body structure and the physiological signal producing system located within the interior space.

[0098] Clause 14. The biosensing device testing assembly of clause 1 , any other suitable clause, or any other suitable combination of clauses, wherein the phantom body structure includes an exterior layer that simulates an epidermis skin layer of the living subject and at least one vessel arranged under the exterior layer.

[0099] Clause 15. The biosensing device testing assembly of clause 14, any other suitable clause, or any other suitable combination of clauses, wherein the exterior layer includes a free outer surface shaped to support and contact wearable biosensing devices and an inner surface opposite the free outer surface.

[0100] Clause 16. The biosensing device testing assembly of clause 15, any other suitable clause, or any other suitable combination of clauses, wherein the at least one vessel is arranged under the inner surface of the exterior layer and the at least one vessel is shaped to define a passageway extending therethrough filled with the fluid.

[0101] Clause 17. The biosensing device testing assembly of clause 15, any other suitable clause, or any other suitable combination of clauses, wherein the phantom body structure further includes an interior layer that simulates a dermis skin layer of the living subject, and wherein the interior layer is located under the exterior layer.

[0102] Clause 18. The biosensing device testing assembly of clause 17, any other suitable clause, or any other suitable combination of clauses, wherein the exterior layer has a first compliance value and the interior layer has a second compliance value, and wherein the first and second compliance values are different from one another.

[0103] Clause 19. The biosensing device testing assembly of clause 18, any other suitable clause, or any other suitable combination of clauses, wherein the first compliance value is greater than the second compliance value.

[0104] Clause 20. A biosensing device testing assembly comprising a phantom body structure having mechanical properties and optical properties to simulate a body structure of a living subject; a physiological signal producing system configured to produce simulated physiological signals including user-selected simulated cardiac performance characteristics in the phantom body structure, the physiological signal producing system including a pump unit configured to direct fluid through the phantom body structure to cause pulsations of the phantom body structure; and a controller configured to operate the pump unit to cause the pulsations of the phantom body structure via pumping of the fluid at preselected frequencies and amplitudes though the phantom body structure based on the user-selected simulated cardiac performance characteristics so that wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the pulsations and / or identification of the user-selected simulated cardiac performance characteristics.

[0105] Clause 21 . The biosensing device testing assembly of clause 20, any other suitable clause, or any other suitable combination of clauses, wherein the user- selected simulated cardiac performance characteristics include at least two of heart rate variability, wave morphology, blood pressure, heart rate, and / or respiration rate.

[0106] Clause 22. The biosensing device testing assembly of clause 20, any other suitable clause, or any other suitable combination of clauses, wherein a first preselected frequency is associated with an increase in heart rate and a second preselected frequency is associated with a decrease in heart rate, and wherein the first preselected frequency is greater than the second preselected frequency.

[0107] Clause 23. The biosensing device testing assembly of clause 20, any other suitable clause, or any other suitable combination of clauses, wherein the pump unit includes a pump configured to direct the fluid through the phantom body structure and at least one pressure sensor in direct fluid communication with the fluid that is configured to determine a fluid pressure of the fluid.

[0108] Clause 24. The biosensing device testing assembly of clause 20, any other suitable clause, or any other suitable combination of clauses, wherein the simulated physiological signals include user-selected simulated skin temperatures, and wherein the physiological signal producing system further includes a temperature control unit configured to adjust a temperature of the phantom body structure.

[0109] Clause 25. The biosensing device testing assembly of clause 24, any other suitable clause, or any other suitable combination of clauses, wherein the controller is configured to operate the temperature control unit to adjust the temperature of the phantom body structure at preselected temperatures based on the user-selected simulated skin temperatures.

[0110] Clause 26. The biosensing device testing assembly of clause 25, any other suitable clause, or any other suitable combination of clauses, wherein the temperature control unit includes a heater arranged underneath the phantom body structure to adjust the temperature of the phantom body structure and at least one temperature sensor configured to determine the temperature of the phantom body structure.

[0111] Clause 27. The biosensing device testing assembly of clause 20, any other suitable clause, or any other suitable combination of clauses, wherein the physiological signal producing system includes a motor configured to move the phantom body structure to cause macro-movements of the phantom body structure.

[0112] Clause 28. The biosensing device testing assembly of clause 27, any other suitable clause, or any other suitable combination of clauses, wherein the simulated physiological signals include user-selected simulated kinetics, and wherein the controller is configured to operate the motor to cause the macro-movements of the phantom body structure with preselected motion patterns based on the user-selected simulated kinetics.

[0113] Clause 29. The biosensing device testing assembly of clause 28, any other suitable clause, or any other suitable combination of clauses, wherein the user- selected simulated kinetics include running, walking, cycling, and / or swimming.

[0114] Clause 30. The biosensing device testing assembly of clause 28, any other suitable clause, or any other suitable combination of clauses, wherein the macromovements are detectable on an inertial measurement unit.

[0115] Clause 31 . The biosensing device testing assembly of clause 20, any other suitable clause, or any other suitable combination of clauses, wherein the pulsations are undetectable on an inertial measurement unit.

[0116] Clause 32. A biosensing device testing assembly comprising a phantom body structure that simulates a body structure of a living subject, wherein the phantom body structure is configured to support a wearable biosensing device thereon, thephantom body structure including an exterior layer that simulates an epidermis skin layer of the living subject, the exterior layer having a free outer surface shaped to support and contact the wearable biosensing device and an inner surface opposite the free outer surface, and at least one vessel arranged under the inner surface of the exterior layer, the at least one vessel shaped to define a passageway extending therethrough filled with fluid to be carried along the phantom body structure for detection by the wearable biosensing device while the wearable biosensing device is being supported on the phantom body structure.

[0117] Clause 33. The biosensing device testing assembly of clause 32, any other suitable clause, or any other suitable combination of clauses, wherein the phantom body structure further includes an interior layer that simulates a dermis skin layer of the living subject, and wherein the interior layer is located under the exterior layer.

[0118] Clause 34. The biosensing device testing assembly of clause 33, any other suitable clause, or any other suitable combination of clauses, wherein the interior layer includes an outer surface that engages the inner surface of the exterior layer and an inner surface opposite the outer surface.

[0119] Clause 35. The biosensing device testing assembly of clause 34, any other suitable clause, or any other suitable combination of clauses, wherein the at least one vessel is located between the outer surface and the inner surface of the interior layer.

[0120] Clause 36. The biosensing device testing assembly of clause 35, any other suitable clause, or any other suitable combination of clauses, wherein the phantom body structure further includes a sub-interior layer that simulates a hypodermis skin layer of the living subject, and wherein the sub-interior layer is located under the interior layer.

[0121] Clause 37. The biosensing device testing assembly of clause 36, any other suitable clause, or any other suitable combination of clauses, wherein the exterior layer has a first thickness and the interior layer has a second thickness greater than the first thickness.

[0122] Clause 38. The biosensing device testing assembly of clause 37, any other suitable clause, or any other suitable combination of clauses, wherein the subinterior layer has a third thickness that is greater than the second thickness.

[0123] Clause 39. The biosensing device testing assembly of clause 38, any other suitable clause, or any other suitable combination of clauses, wherein the at least one vessel has a fourth thickness that is greater than the first thickness and less than the third thickness.

[0124] Clause 40. The biosensing device testing assembly of clause 34, any other suitable clause, or any other suitable combination of clauses, wherein the exterior layer has a first compliance value and the interior layer has a second compliance value, and wherein the first and second compliance values are different from one another.

[0125] Clause 41 . The biosensing device testing assembly of clause 40, any other suitable clause, or any other suitable combination of clauses, wherein the first compliance value is greater than the second compliance value.

[0126] Clause 42. The biosensing device testing assembly of clause 40, any other suitable clause, or any other suitable combination of clauses, wherein the at least one vessel has a third compliance value.

[0127] Clause 43. The biosensing device testing assembly of clause 42, any other suitable clause, or any other suitable combination of clauses, wherein the third compliance value is less than the first compliance value.

[0128] Clause 44. The biosensing device testing assembly of clause 43, any other suitable clause, or any other suitable combination of clauses, wherein the third compliance value is greater than the second compliance value.

[0129] Clause 45. The biosensing device testing assembly of clause 32, any other suitable clause, or any other suitable combination of clauses, wherein the exterior layer comprises platinum-catalyzed silicon rubber doped with calcium carbonate and silicone oil.

[0130] Clause 46. The biosensing device testing assembly of clause 32, any other suitable clause, or any other suitable combination of clauses, wherein the exterior layer is characterized by light absorption and reduced scattering coefficients equivalent to absorption and reduced scattering coefficients of skin tones within levels 1-10 on the Monk Skin Tone Scale.

[0131] Clause 47. The biosensing device testing assembly of clause 32, any other suitable clause, or any other suitable combination of clauses, further comprising a temperature control unit configured to adjust a temperature of the exterior layer ofthe phantom body structure to simulate skin temperature variability for detection by the wearable biosensing device, the temperature control unit including a heater located under the inner surface of the exterior layer.

[0132] Clause 48. The biosensing device testing assembly of clause 47, any other suitable clause, or any other suitable combination of clauses, wherein the temperature control unit further includes at least one temperature sensor configured to determine the temperature of the exterior layer.

[0133] Clause 49. The biosensing device testing assembly of clause 47, any other suitable clause, or any other suitable combination of clauses, wherein the temperature control unit further includes at least one temperature sensor configured to determine the temperature of the heater.

[0134] Clause 50. The biosensing device testing assembly of clause 32, any other suitable clause, or any other suitable combination of clauses, further comprising a temperature control unit configured to adjust a temperature of an interior space housing the phantom body structure therein to simulate environmental temperature variability for detection by the wearable biosensing device, the temperature control unit including a heater located in the interior space.

[0135] Clause 51 . The biosensing device testing assembly of clause 32, any other suitable clause, or any other suitable combination of clauses, further comprising a pump unit configured to direct the fluid through the at least one vessel to simulate blood flow for detection by the wearable biosensing device.

[0136] Clause 52. The biosensing device testing assembly of clause 51 , any other suitable clause, or any other suitable combination of clauses, wherein the pump unit includes a pump and at least one pressure sensor in direct fluid communication with the fluid and configured to determine a fluid pressure of the fluid flowing through the at least one vessel.

[0137] While the disclosure has been illustrated and described in detail in the foregoing drawings and description, the same is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments thereof have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.

Claims

WHAT IS CLAIMED IS:1 . A biosensing device testing assembly comprising a phantom body structure having mechanical properties and optical properties to simulate a body structure of a living subject, and a physiological signal producing system configured to produce simulated physiological signals in the phantom body structure, the physiological signal producing system including a motor configured to move the phantom body structure to cause macro-movements of the phantom body structure and a pump unit configured to direct fluid through the phantom body structure to cause pulsations of the phantom body structure, the pulsations being undetectable on an inertial measurement unit.

2. The biosensing device testing assembly of claim 1 , any other suitable claim, or any other suitable combination of claims, wherein the pump unit includes a pump configured to direct the fluid through the phantom body structure and at least one pressure sensor in direct fluid communication with the fluid that is configured to determine a fluid pressure of the fluid.

3. The biosensing device testing assembly of claim 1 , any other suitable claim, or any other suitable combination of claims, wherein the simulated physiological signals include user-selected simulated skin temperatures, and wherein the physiological signal producing system further includes a temperature control unit configured to adjust a temperature of the phantom body structure.

4. The biosensing device testing assembly of claim 3, any other suitable claim, or any other suitable combination of claims, further comprising a controller configured to operate the temperature control unit to adjust the temperature of the phantom body structure at preselected temperatures based on the user-selected simulated skin temperatures so that wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the preselected temperatures and / or identification of the user-selected simulated skin temperatures.

5. The biosensing device testing assembly of claim 3, any other suitable claim, or any other suitable combination of claims, wherein the temperature control unit includes a heater arranged underneath the phantom body structure to adjust the temperature of the phantom body structure and at least one temperature sensor configured to determine the temperature of the phantom body structure.

6. The biosensing device testing assembly of claim 1 , any other suitable claim, or any other suitable combination of claims, wherein the simulated physiological signals include user-selected simulated kinetics, and wherein the biosensing device testing assembly further comprises a controller configured to operate the motor to cause the macro-movements of the phantom body structure with preselected motion patterns based on the user-selected simulated kinetics so that wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the macro-movements and / or identification of the user- selected simulated kinetics.

7. The biosensing device testing assembly of claim 6, any other suitable claim, or any other suitable combination of claims, wherein the user-selected simulated kinetics include running, walking, cycling, and / or swimming.

8. The biosensing device testing assembly of claim 6, any other suitable claim, or any other suitable combination of claims, wherein the macromovements are detectable on the inertial measurement unit.

9. The biosensing device testing assembly of claim 6, any other suitable claim, or any other suitable combination of claims, wherein the simulated physiological signals include user-selected simulated cardiac performance characteristics, and wherein the controller is configured to operate the pump unit to cause the pulsations of the phantom body structure via pumping of the fluid at preselected frequencies and / or amplitudes though the phantom body structure based on the user-selected simulated cardiac performance characteristics so that the wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the pulsations and / or identification of the user-selected simulated cardiac performance characteristics.

10. The biosensing device testing assembly of claim 9, any other suitable claim, or any other suitable combination of claims, wherein the user-selected simulated cardiac performance characteristics include at least two of heart rate variability, wave morphology, blood pressure, heart rate, and / or respiration rate.1 1 . The biosensing device testing assembly of claim 9, any other suitable claim, or any other suitable combination of claims, wherein a first preselected frequency is associated with an increase in heart rate and a second preselectedfrequency is associated with a decrease in heart rate, and wherein the first preselected frequency is greater than the second preselected frequency.

12. The biosensing device testing assembly of claim 9, any other suitable claim, or any other suitable combination of claims, wherein the controller is in communication with the wearable biosensing devices, and wherein the controller is configured to compare the user-selected simulated cardiac performance characteristics with detected physiological signals by the wearable biosensing devices to optimize performance of the wearable biosensing devices.

13. The biosensing device testing assembly of claim 1 , any other suitable claim, or any other suitable combination of claims, further comprising an enclosure formed to define an interior space therein, the phantom body structure and the physiological signal producing system located within the interior space.

14. The biosensing device testing assembly of claim 1 , any other suitable claim, or any other suitable combination of claims, wherein the phantom body structure includes an exterior layer that simulates an epidermis skin layer of the living subject and at least one vessel arranged under the exterior layer.

15. The biosensing device testing assembly of claim 14, any other suitable claim, or any other suitable combination of claims, wherein the exterior layer includes a free outer surface shaped to support and contact wearable biosensing devices and an inner surface opposite the free outer surface.

16. The biosensing device testing assembly of claim 15, any other suitable claim, or any other suitable combination of claims, wherein the at least one vessel is arranged under the inner surface of the exterior layer and the at least one vessel is shaped to define a passageway extending therethrough filled with the fluid.

17. The biosensing device testing assembly of claim 15, any other suitable claim, or any other suitable combination of claims, wherein the phantom body structure further includes an interior layer that simulates a dermis skin layer of the living subject, and wherein the interior layer is located under the exterior layer.

18. The biosensing device testing assembly of claim 17, any other suitable claim, or any other suitable combination of claims, wherein the exterior layer has a first compliance value and the interior layer has a second compliance value, and wherein the first and second compliance values are different from one another.

19. The biosensing device testing assembly of claim 18, any other suitable claim, or any other suitable combination of claims, wherein the first compliance value is greater than the second compliance value.

20. A biosensing device testing assembly comprising a phantom body structure having mechanical properties and optical properties to simulate a body structure of a living subject, a physiological signal producing system configured to produce simulated physiological signals including user-selected simulated cardiac performance characteristics in the phantom body structure, the physiological signal producing system including a pump unit configured to direct fluid through the phantom body structure to cause pulsations of the phantom body structure, and a controller configured to operate the pump unit to cause the pulsations of the phantom body structure via pumping of the fluid at preselected frequencies and amplitudes though the phantom body structure based on the user-selected simulated cardiac performance characteristics so that wearable biosensing devices supported on the phantom body structure can be evaluated as to detection of the pulsations and / or identification of the user-selected simulated cardiac performance characteristics.21 . The biosensing device testing assembly of claim 20, any other suitable claim, or any other suitable combination of claims, wherein the user-selected simulated cardiac performance characteristics include at least two of heart rate variability, wave morphology, blood pressure, heart rate, and / or respiration rate.

22. The biosensing device testing assembly of claim 20, any other suitable claim, or any other suitable combination of claims, wherein a first preselected frequency is associated with an increase in heart rate and a second preselected frequency is associated with a decrease in heart rate, and wherein the first preselected frequency is greater than the second preselected frequency.

23. The biosensing device testing assembly of claim 20, any other suitable claim, or any other suitable combination of claims, wherein the pump unit includes a pump configured to direct the fluid through the phantom body structure and at least one pressure sensor in direct fluid communication with the fluid that is configured to determine a fluid pressure of the fluid.

24. The biosensing device testing assembly of claim 20, any other suitable claim, or any other suitable combination of claims, wherein the simulatedphysiological signals include user-selected simulated skin temperatures, and wherein the physiological signal producing system further includes a temperature control unit configured to adjust a temperature of the phantom body structure.

25. The biosensing device testing assembly of claim 24, any other suitable claim, or any other suitable combination of claims, wherein the controller is configured to operate the temperature control unit to adjust the temperature of the phantom body structure at preselected temperatures based on the user-selected simulated skin temperatures.

26. The biosensing device testing assembly of claim 25, any other suitable claim, or any other suitable combination of claims, wherein the temperature control unit includes a heater arranged underneath the phantom body structure to adjust the temperature of the phantom body structure and at least one temperature sensor configured to determine the temperature of the phantom body structure.

27. The biosensing device testing assembly of claim 20, any other suitable claim, or any other suitable combination of claims, wherein the physiological signal producing system includes a motor configured to move the phantom body structure to cause macro-movements of the phantom body structure.

28. The biosensing device testing assembly of claim 27, any other suitable claim, or any other suitable combination of claims, wherein the simulated physiological signals include user-selected simulated kinetics, and wherein the controller is configured to operate the motor to cause the macro-movements of the phantom body structure with preselected motion patterns based on the user-selected simulated kinetics.

29. The biosensing device testing assembly of claim 28, any other suitable claim, or any other suitable combination of claims, wherein the user-selected simulated kinetics include running, walking, cycling, and / or swimming.

30. The biosensing device testing assembly of claim 28, any other suitable claim, or any other suitable combination of claims, wherein the macromovements are detectable on an inertial measurement unit.31 . The biosensing device testing assembly of claim 20, any other suitable claim, or any other suitable combination of claims, wherein the pulsations are undetectable on an inertial measurement unit.

32. A biosensing device testing assembly comprisinga phantom body structure that simulates a body structure of a living subject, wherein the phantom body structure is configured to support a wearable biosensing device thereon, the phantom body structure including an exterior layer that simulates an epidermis skin layer of the living subject, the exterior layer having a free outer surface shaped to support and contact the wearable biosensing device and an inner surface opposite the free outer surface, and at least one vessel arranged under the inner surface of the exterior layer, the at least one vessel shaped to define a passageway extending therethrough filled with fluid to be carried along the phantom body structure for detection by the wearable biosensing device while the wearable biosensing device is being supported on the phantom body structure.

33. The biosensing device testing assembly of claim 32, any other suitable claim, or any other suitable combination of claims, wherein the phantom body structure further includes an interior layer that simulates a dermis skin layer of the living subject, and wherein the interior layer is located under the exterior layer.

34. The biosensing device testing assembly of claim 33, any other suitable claim, or any other suitable combination of claims, wherein the interior layer includes an outer surface that engages the inner surface of the exterior layer and an inner surface opposite the outer surface.

35. The biosensing device testing assembly of claim 34, any other suitable claim, or any other suitable combination of claims, wherein the at least one vessel is located between the outer surface and the inner surface of the interior layer.

36. The biosensing device testing assembly of claim 35, any other suitable claim, or any other suitable combination of claims, wherein the phantom body structure further includes a sub-interior layer that simulates a hypodermis skin layer of the living subject, and wherein the sub-interior layer is located under the interior layer.

37. The biosensing device testing assembly of claim 36, any other suitable claim, or any other suitable combination of claims, wherein the exterior layer has a first thickness and the interior layer has a second thickness greater than the first thickness.

38. The biosensing device testing assembly of claim 37, any other suitable claim, or any other suitable combination of claims, wherein the sub-interior layer has a third thickness that is greater than the second thickness.

39. The biosensing device testing assembly of claim 38, any other suitable claim, or any other suitable combination of claims, wherein the at least one vessel has a fourth thickness that is greater than the first thickness and less than the third thickness.

40. The biosensing device testing assembly of claim 34, any other suitable claim, or any other suitable combination of claims, wherein the exterior layer has a first compliance value and the interior layer has a second compliance value, and wherein the first and second compliance values are different from one another.41 . The biosensing device testing assembly of claim 40, any other suitable claim, or any other suitable combination of claims, wherein the first compliance value is greater than the second compliance value.

42. The biosensing device testing assembly of claim 40, any other suitable claim, or any other suitable combination of claims, wherein the at least one vessel has a third compliance value.

43. The biosensing device testing assembly of claim 42, any other suitable claim, or any other suitable combination of claims, wherein the third compliance value is less than the first compliance value.

44. The biosensing device testing assembly of claim 43, any other suitable claim, or any other suitable combination of claims, wherein the third compliance value is greater than the second compliance value.

45. The biosensing device testing assembly of claim 32, any other suitable claim, or any other suitable combination of claims, wherein the exterior layer comprises platinum-catalyzed silicon rubber doped with calcium carbonate and silicone oil.

46. The biosensing device testing assembly of claim 32, any other suitable claim, or any other suitable combination of claims, wherein the exterior layer is characterized by light absorption and reduced scattering coefficients equivalent to absorption and reduced scattering coefficients of skin tones within levels 1 -10 on the Monk Skin Tone Scale.

47. The biosensing device testing assembly of claim 32, any other suitable claim, or any other suitable combination of claims, further comprising a temperature control unit configured to adjust a temperature of the exterior layer of the phantom body structure to simulate skin temperature variability for detection by the wearable biosensing device, the temperature control unit including a heater located under the inner surface of the exterior layer.

48. The biosensing device testing assembly of claim 47, any other suitable claim, or any other suitable combination of claims, wherein the temperature control unit further includes at least one temperature sensor configured to determine the temperature of the exterior layer.

49. The biosensing device testing assembly of claim 47, any other suitable claim, or any other suitable combination of claims, wherein the temperature control unit further includes at least one temperature sensor configured to determine the temperature of the heater.

50. The biosensing device testing assembly of claim 32, any other suitable claim, or any other suitable combination of claims, further comprising a temperature control unit configured to adjust a temperature of an interior space housing the phantom body structure therein to simulate environmental temperature variability for detection by the wearable biosensing device, the temperature control unit including a heater located in the interior space.51 . The biosensing device testing assembly of claim 32, any other suitable claim, or any other suitable combination of claims, further comprising a pump unit configured to direct the fluid through the at least one vessel to simulate blood flow for detection by the wearable biosensing device.

52. The biosensing device testing assembly of claim 51 , any other suitable claim, or any other suitable combination of claims, wherein the pump unit includes a pump and at least one pressure sensor in direct fluid communication with the fluid and configured to determine a fluid pressure of the fluid flowing through the at least one vessel.

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