Patent Application
20250064399
Embodiments of the disclosure relate to the field of wearable biosensing devices. More specifically, one embodiment of the disclosure relates to a biosensing device that is mounted to a portion of the body using an adhesive and features a shielding component to avoid leakage of light during a detection phase.
The following description includes information that may be useful in understanding the described invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Over the last decade, there has been an increasing number of wearable biosensing devices. These devices include one or more biosensors, which collect health-related data from a user. Most of these wearable biosensing devices include a display (e.g., smart watches, Fitbits®, etc.) and are mounted on the user's wrist using a band which encircles the wrist. However, these display-based devices are costly, non-disposable, and cannot be targeted to monitor certain health characteristics, such as blood flow for example, at other location on the patient besides the wrist area.
Adhesive-based wearable biosensing devices tend to be disposable. Their reliability in data collection may be influenced by the amount of sourced light that is accidentally detected by a photodiode. The presence of “leaked” sourced light is quite problematic, especially for photo-plethysmograph (PPG) sensors, because PPG sensors deploy photodiodes responsible for detecting light reflected from vessels under the patient's skin in close proximity to the light sources. When light is leaked from the source to the photodiode, without traveling through the vessel, the analytic results produced from the detected light are incorrect. This may cause erred treatment.
Embodiments of the invention are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:
Embodiments of the present disclosure generally relate to a wearable biosensing device, which features biosensing logic deployed within a housing that is attached to a patient (wearer) through an adhesive. The biosensing logic includes an electronics assembly, a power assembly, and a sensing assembly positioned between the electronics assembly and the power assembly. Herein, according to one embodiment of the disclosure, the sensing assembly includes a substrate (e.g., printed circuit board) with components mounted thereon. For example, the mounted components may include, but are not limited or restricted to (i) a thermal sensing component (e.g., temperature sensor, etc.), (ii) an audio sensing component (e.g., microphone, etc.) and (iii) a plurality of plethysmograph (PPG) sensors, all of which are positioned on a first (posterior) surface of the substrate.
Positioned adjacent to the sensing assembly, a shielding component includes a plurality of openings. Each opening is configured as a dedicated vertical channel (or conduit) for alignment with (1) the thermal sensing component, (2) the audio sensing component, and (3) each sensing elements associated with a PPG sensor. Therefore, the shielding component is adapted to provide shielding for the gathering of thermal, acoustic, and light-based data. According to one embodiment of the disclosure, the wearable biosensing device is particularly advantageous for monitoring characteristics and operability of a vessel (e.g., an artery, a vein, or an arteriovenous (AV) fistula) by detecting light sourced by a sensing element of the PPG sensor after reflection from and/or refraction through the vessel.
According to one embodiment of the disclosure, the detected light corresponds to collected information associated with physiological properties of that vessel and/or the biological fluid propagating therethrough (e.g., flow, fluid composition, etc.). This information may be useful in monitoring the health of a patient, especially dialysis patients, and may be used to generate an alert signifying a detected health event that is being (or could be) experienced by the wearer of the wearable biosensing device. The biosensing logic may include other sensors (e.g., accelerometer, optical, bioimpedance, electrocardiography etc.), where the sensing elements are configured, alone or in cooperation, to detect/monitor a physiological property and convert the monitored property into an electrical signal, which is subsequently converted to a data representation of the monitored property indicated by the electrical signal. The data representation enables remote monitoring.
As an illustrative example, the wearable biosensing device (with remote monitoring) may be mounted over or proximate to a vessel, such as an artery, a vein, or an arteriovenous (AV) fistula as disclosed in U.S. Pat. Nos. 11,045,123 and 11,406,274, the contents of both of which are incorporated by reference herein. The AV fistula is a surgical connection made between an artery and a vein, usually created by a vascular specialist. The AV fistula facilitates more efficient dialysis than a “line” port due to quicker blood flow during a dialysis session. Normally, the AV fistula is typically located in your arm, however, if necessary, it can be placed in the leg. Other uses for the wearable biosensing device include mounting on the chest for monitoring cardiac functions or on the abdomen for prenatal or intestinal monitoring.
Herein, the shielding component includes a plurality of regions, including a first shield region, a second shield region, and a third shield region. The first shield region includes a cut-out area and a first opening. The cut-out area is sized to accommodate (receive) and retain the thermal sensing component, where a thermal pad associated with the thermal sensing component partially extends from the first cut-out area. The first cut-out area allows for heat conductive contact between the thermal pad and the skin of the user.
The first opening may be configured as a conduit to allow for audio (e.g., sound waves) to propagate to the audio sensing component. Upon receipt of the audio featuring an audio pattern, the wearable biosensing device may be configured to perform certain actions in response to detection of a particular audio pattern. For example, certain detected audio frequencies and/or audio patterns may be used to identify a change in operability (e.g., flow rate, occlusion of the vessel, etc.) experienced by the wearable biosensing device.
The shielding component further includes the second shield region and the third shield region. The second shield region includes openings (e.g., conduits) for sensing elements of a first PPG sensor. Similarly, the third shield region includes openings for sensing elements of a second PPG sensor as described below. The openings for the sensing elements within the second shield region are separated by lateral surface areas, where each lateral surface area has a lesser width than a vertical surface area created between the second shield region and the third shield region.
In the following description, certain terminology is used to describe aspects of the invention. The terms “logic” or “assembly” are representative of hardware, firmware, and/or software that is configured to perform one or more functions. As hardware, the logic (or assembly) may include circuitry associated with data processing, data storage and/or data communications. Examples of such circuitry may include, but are not limited or restricted to a processor, a programmable gate array, a microcontroller, an application specific integrated circuit, wireless receiver, transmitter and/or transceiver circuitry, sensors, semiconductor memory, and/or combinatorial logic.
Alternatively, or in combination with the hardware circuitry described above, the logic (or assembly) may include software in the form of one or more software modules (hereinafter, “software module(s)”), which may be configured to support certain functionality upon execution by data processing circuitry. For instance, a software module may constitute an executable applications, daemon application, application programming interface (API), subroutine, function, procedure, applet, servlet, routine, source code, shared library/dynamic load library, or one or more instructions. The “software module(s)” may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical, or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; a semiconductor memory; non-persistent storage such as volatile memory (e.g., any type of random access memory “RAM”); persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, a hard disk drive, an optical disc drive, a portable memory device, or cloud-based storage (e.g., AWS S3 storage, etc. As firmware, the logic (or assembly) may be stored in persistent storage.
The terms “member” and “element” may be construed as a hardware-based logic. The term “attach” and other tenses of the term (e.g., attached, attaching, etc.) may be construed as physically connecting a first member to a second member.
The term “interconnect” may be construed as a physical or logical communication path between two or more components such as a pair of assemblies. For instance, as a physical communication path, wired interconnects in the form of electrical wiring, optical fiber, cable, and/or bus trace. As a logical communication path, the interconnect may be a wireless channel using short range signaling (e.g., Bluetooth™) or longer range signaling (e.g., infrared, radio frequency “RF” or the like).
Finally, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and/or C” mean “any of the following: A; B; C; A and B; A and C; B and C; A, B and C.” An exception to this definition will occur only when a combination of elements, functions, steps, or acts are in some way inherently mutually exclusive.
As this invention is susceptible to embodiments of many different forms, it is intended that the present disclosure is to be considered as an example of the principles of the invention and not intended to limit the invention to the specific embodiments shown and described.
Referring to
More specifically, the remote monitoring may involve transmission of the collected information to a local hub 130. The “local hub” 130 constitutes logic (e.g., a device, an application, etc.) that converts a first data representation 160 of the collected information provided in accordance with a first transmission protocol (e.g., Bluetooth™ or other short distance (wireless) transmission protocol) into a second data representation 165. The second data representation 165 may be provided in accordance with a second transmission protocol (e.g., cellular, WiFi™, or other long distance (wireless) transmission protocol) and routes the second data representation 165 to the sensory data processing system 140. The sensory data processing system 140 may include an alert system (not shown), which generates and sends the alert (notification) 150 upon detecting an occurring (or potential) health event that requires attention by a doctor and/or another specified person (including the patient) responsible for addressing any occurring (or potential) health event. The alert 150 may be sent via network 170 for notification over a monitored website or may be sent from the sensor data processing system 140 as an electronic mail (e-mail) message, a text message, or any other signaling mechanism.
Referring to
As an illustrative example, according to one embodiment of the disclosure, the lobes 205 are positioned in a linear orientation, with a first plurality of lobes (e.g., first, second and third lobes 210-212) interconnected by a second plurality of lobes (e.g., fourth and fifth lobes 213-214). The fourth and fifth lobes 213-214 are configured to house interconnects 222 and 223, which provide electrical connections between an electronics assembly 225, a sensing assembly 230, and a power assembly 235 of the biosensing logic 220. As shown, each of the assemblies, namely the electronic assembly 225, the sensing assembly 230, and the power assembly 235, are maintained within a protective package 226, 231 and 236, respectively.
According to one embodiment of the disclosure, housed within the first lobe 210 as shown in
As further shown in
Referring still to
The power assembly 235 includes a substrate 370, power management logic 375, and power supply logic 380. The power supply logic 380 is configured to provide power to both the components within the sensing assembly 230 as well as the electronics assembly 225. The power management logic 375 is configured to control the distribution of power (e.g., amount, intermittent release, or duration), including disabling of power when the wearable biosensing device 100 is not installed or detached to the wearer to avoid false data collection. The substrate 340 of the sensing assembly 230 may include hardwired traces (power layers) for routing of power from the power supply assembly 235 to components of the sensing assembly 230 and/or components of the electronics assembly 225.
Referring back to
As an optional feature, the second housing 250 may include a first raised fastening element 260 and a second raised fastening element 262. These raised fastening elements 260 and 262 are formed on a top (anterior-facing) side 264 of the second housing 250 for attachments to complementary fastening elements 238 and 239 positioned on outer edges of the protective packages 226 and 236, respectively. As shown, the raised fastening elements 260 and 262 are inserted into and secured by fastening elements 238 and 239, and upon applying sufficient forces, the raised fastening elements 260 and 262 may be removed from the fastening elements 238 and 239. As a result, the first housing 200 and the second housing 250 substantially encapsulate the protective packages 226 and 236 while providing partial encapsulation of the protective package 231 inclusive of the sensing assembly 230.
Additionally, the adhesive layer 270 is applied to at least a portion of a bottom surface 266 of the second housing 250. The adhesive layer 270 is adapted to attach to a surface of a patient's skin and remain attached thereto. Alternatively, the adhesive layer 270 may include multiple layers for replacement of the second housing 250 without replacing the packaged biosensing logic 220.
In accordance with another embodiment of the disclosure, in lieu of the fastening elements 238 and 239 in combination with the raised fastening elements 260 and 262, the plurality of magnets (not shown) may be positioned within the second housing 250. These magnets may establish a magnetic coupling to metal fastening elements (e.g., metal connection points) positioned under the power assembly 235 and/or electronics assembly 225 fand/or positioned at ends of the protective packages 226 and 236. Alternatively, the magnets may be positioned as part of the biosensing logic 220 and accessible to metal fastening elements positioned on the second housing 250.
Referring to
As an illustrative example, each of the PPG sensors 355 (e.g., the first PPG sensor 410) includes one or more light sourcing elements. Herein, the light sourcing elements may include light emitting diodes (LEDs) of different wavelength ranges ranging from 500 nanometers (nm) to 1500 nm. For example, one or more LEDs emitting light with wavelengths ranging between 520-540 nanometers (nm) (e.g., green LED with light emissions of approximately 532 nm), one or more LEDs emitting light with wavelengths ranging between 645-665 nm (e.g., red LED with light emissions of approximately 655 nm), and one or more LEDs emitting light with wavelengths ranging between 930-950 nm (e.g., infrared “IR” LED with light emissions of approximately 940 nm). Besides the light sourcing elements, the sensing assembly 230 further includes light detecting elements, which may include one or more photodiodes (photodetectors) configured to capture reflected or refracted light emitted from a light sourcing element after traveling across an optical path with passage to or through the vessel.
Referring now to
Herein, each of the LEDs 432-434 is selected to emit light at a wavelength corresponding to the biological metrics to be measured. For example, hematocrit (Hct) may be measured using infrared (IR) light produced by IR LED 434. Some measurements, such as, for example, oxygen saturation, may be measured using optical measurements from red and IR light produced by red LED 433 and IR LED 434. As a result, the type of LEDs (as determined by the emission wavelengths) may be selected based on the interaction of the light and properties of the tissue for the metric being measured. The arrangement of the LEDs is intended to provide multiple source detector combinations to assess the tissue using multiple optical paths for each wavelength.
The second group of sensing elements 435 includes green optimized photodetector 436 while the third group of sensing elements 440 includes a green LED 442 and a broadband photodetector 443. According to this embodiment of the disclosure, the broadband photodetector 443 is positioned at a second end portion of the PPG sensor 410, opposite from the first end portion. The additional distance between the light sourcing elements (red LED 433 and/or IR LED) and the light detecting element (e.g., broadband photodetector 443) is designed to increase an optical path length for light emitted from the red LED 433 and/or IR LED 434 and detected by the broadband photodetector 443. This increased optical path length measures vessels other than superficial vessels immediately under the skin and avoids reflectance error caused by leaked light from these LEDs 433 or 434. In contrast, the green optimized photodetector 436 are interposed between the green LED 432 and green LED 442, and thus, the optical path length for the green emitted light is intended to be shorter to capture a greater number of photons as attenuation due to perfused tissue is substantially greater for green as compared to red/NIR frequency ranges.
The second PPG sensor 420 features the same LED/photodiode architecture as the first PPG sensor 410. The second PPG sensor 420 may operate concurrently with the first PPG sensor 410 or may operate at different time periods. The operability of the PPG sensors 355 are controlled by the electronics assembly 225 in which control signaling is provided through interconnect 222 and/or logic deployed as part of the sensing assembly 230. Although not shown, the PPG sensors 355 may be communicatively coupled to amplifiers for use in amplifying the analytic results. The analytic results may be utilized to understand and monitor fluid flow, vessel characteristics (e.g., depth, diameter, etc.), oxygenation levels of fluid flowing through the vessel, hemoglobin levels, and other metrics to identify whether a status of the health of the patient.
Referring to
As further shown in
The first shield region 510 further includes the first opening 515, which may be configured as a conduit to allow for sound waves to propagate to the audio sensing component 365 and to detect audio. The detected audio may be processed by the processing logic 310 of the electronics assembly 225, and based on the characteristics of the detected audio matching a particular audio pattern, performing certain actions. In particular, certain detected audio frequencies and/or audio patterns may be used to identify a change in operability (e.g., flow rate, etc.) experienced by the wearable biosensing device. For example, the frequency of the audio may be used to identify flow rates, and therefore, an occlusion of the vessel.
It is contemplated that different selected material may be placed within the air gap of the window 515 to enhance or filter different aspects of the detected audio signal. As an illustrative example, the audio frequency of human speech is relatively higher than the lower frequency of the audio associated with a heartbeat. By selecting a material that operates as a low-pass filter, voice is filtered from audio gathered, and thereby, the signal processing conducted to determine flow rate and/or vessel occlusions that may be assisted with knowledge of the timing of the heartbeat. The material may be deposited as a filling material within the air gap formed by window 515, a membrane laid over the window 515, or the like.
As shown in
In order to account for the patient's motion, one of the shielding areas (e.g., area 543) may be removed to allow light from the green photodiodes 436 to be captured by green LED 432. As a result, a majority of the light from the green photodiode 436 would be captured from reflection of the transmitted light from the tissue, where signaling created from the captured reflection light may be used as a noise cancellation signal to account for motion of the patient with the wearable biosensing device 100.
As shown in
Although not shown, it is contemplated that portion of the first shield region 510, the second shield region 520 and/or the third shield region 530 may be configured with acoustic shielding. For example, as one illustrative embodiment, acoustic shielding may be integrated with window areas of the shielding component 240 in addition to other acoustic shielding materials behind the substrate 340. Alternatively, the second housing 250 could be configured with audio dampening material (e.g., mass loaded vinyl). As yet another alternative embodiment, audio deadening material may include an audio deadening material positioned between the second housing 250 and the substrate 340.
The lateral sides 570 and 575 of the shielding component 240 includes recesses 580 and 585, which are sized to engage with the lateral flanges 257-258 of the raised opening 255 positioned on the second housing 250 as shown in
It is further contemplated that, in accordance with another embodiment of the disclosure, one or more of the gaps formed by window areas 515, 542, 544, 546, 562, 564 or 566 may be filled with a transparent material to allow for light transmission and capture, but prevent build-up of contaminants within the gaps. The transparent material within one or more gaps formed by window areas 515, 542, 544, 546, 562, 564 or 566 may be rounded or filed to generally operate as a lens with additional light capturing capabilities and/or shorten path lengths of the light to increase signal.
Referring now
