Wearable monitoring platform

Abstract

The present disclosure describes a wearable monitoring platform capable of capturing and transmitting a wide range of physiological, environmental, and positional data in both clinical and field settings. The system centers around a reusable base unit housed in a partially flexible enclosure, incorporating multi-modal sensors, a controller, edge-processing capabilities, and a dynamic multi-mode communication interface. The wearable is expandable through smart cable modules that provide additional sensing capabilities such as multi-lead electrocardiogram ("ECG"), photoplethysmography ("PPG"), pulse transit time, electroencephalography, and fetal monitoring.

Description

Customer No.143770 Attorney Docket No. SIBEL-009PCT WEARABLE MONITORING PLATFORM CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of and priority to U.S. Provisional Application Serial No.63 / 650,659, filed on May 22, 2024, the content of each of which is hereby incorporated by reference as if expressly set forth in its entirety herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable. TECHNICAL FIELD

[0003] The present disclosure pertains to patient monitoring and, more particularly, to a wearable monitoring platform wearable by a patient in clinical settings such as hospitals (operating rooms, intensive care, emergency departments, etc. and settings other than clinical settings, such as remote or field patient monitoring (telemetry, home care, warfighters). BACKGROUND

[0004] This section of this document introduces information about and / or from the art that may provide context for or be related to the subject matter described herein and / or claimed below. It provides background information to facilitate a better understanding of the various aspects of the present invention. This is a discussion of “related” art. That such art is related in no way implies that it is also “prior” art. The related art may or may not be prior art. The discussion in this section of this document is to be read in this light, and not as admissions of prior art.

[0005] Health-care industries may seek to reduce patient-care cost by shortening stays in the intensive care unit (“ICU”) and the hospital in general. A wearable monitoring platform suitable for high-acuity patients is intended to monitor patients' health in a wide variety of settings, from advanced hospitals to homes to low-resource situations such as military action zones, disaster relief, and emergency response.

[0006] Conventional monitoring systems suffer from various limitations including bulkiness, weight, restricted wireless coverage, and limited portability across care environments. These challenges hinder seamless monitoring during transport, in field use, or across different units of a medical facility. SUMMARY

[0007] The present disclosure describes a wearable monitoring platform capable of capturing and transmitting a wide range of physiological, environmental, and positional data in both clinical and field settings. The system centers around a reusable base unit housed in a partially flexibleCustomer No.143770 Attorney Docket No. SIBEL-009PCT enclosure, incorporating multi-modal sensors, a controller, edge-processing capabilities, and a dynamic multi-mode communication interface. The wearable is expandable through smart cable modules that provide additional sensing capabilities such as multi-lead electrocardiogram (“ECG”), photoplethysmography (“PPG”), pulse transit time, electroencephalography, and fetal monitoring.

[0008] Some embodiments include UWB for real-time patient tracking and support synchronized sensing for compound measurements. The platform is designed for versatility, with support for varying connectivity environments and adaptive power-saving strategies driven by intelligent radio switching. The system’s modularity, portability, and advanced analytics enable applications in critical care, remote monitoring, and low-resource environments.

[0009] In a first aspect, an integrated base unit for use in a wearable monitoring platform, the integrated base unit comprises a multi-modal plurality of sensors; a multi-modal communications interface; a controller; a memory, and a partially pliable housing in which the sensors, communications interface, controller, and memory are disposed. A set of instructions reside on the memory and, when executed by the controller, transmits through the multi-modal communications interface multi-modal data acquired through the sensors.

[0010] In a second aspect, a medical monitoring system comprises a base unit and a patient monitor. The base unit includes a partially flexible housing with a soft encapsulation, a coupling for wired data, a wireless transmitter operable in, and switchable between, a plurality of communication modes, an electrical sensor, a first audio sensor directed at the environment to facilitate noise cancellation, a second audio sensor directed toward a wearer’s body, a sensor for acceleration and spatial orientation, an ambient pressure sensor, a humidity sensor, an ambient temperature sensor, a heat-flux core body temperature sensor, a coupling for an expansion module, a base-unit processor, and a base-unit controller. The patient monitor includes a receiver for the sensor data at least one of a monitor processor, a monitor memory, a monitor visual output, and a monitor audio output.

[0011] In a third aspect, a wearable base unit for medical monitoring comprises a partially flexible housing with a soft encapsulation, a coupling for wired data, a wireless transmitter operable in, and switchable between, a plurality of communication modes, an electrical sensor, a first audio sensor directed at the environment to facilitate noise cancellation, a second audio sensor directed toward a wearer’s body, a sensor for acceleration and spatial orientation, an ambient pressure sensor, a humidity sensor, an ambient temperature sensor, a heat-flux core body temperature sensor, a coupling for an expansion module, a base-unit processor, and a base- unit controller.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0012] In a fourth aspect, a smart cable comprises a probe removably attachable to an adhesive skin-contact pad by a snap or a clip; a defibrillation protection circuit inside the cable, electrode, or cable module; a data coupling for exchanging data with a base unit, a monitor, or another smart cable; and a power coupling for drawing power from the base unit or from an external power source.

[0013] The above presents a simplified summary of the invention as claimed below in order to provide a basic understanding of some aspects of the invention. This summary is not an exhaustive overview of the invention. It is not intended to identify key or critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is discussed later. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In the drawings, like reference numbers generally indicate identical, functionally similar, and / or structurally similar elements.

[0015] FIG.1 is a schematic block diagram of the electronic components for a base unit for the wearable monitoring platform according to one or more examples.

[0016] FIG.2A-FIG.2C depict one particular embodiment for a housing of the base unit in FIG. 1 in perspective, side plan, and top plan views, respectively.

[0017] FIG.3 illustrates additional embodiments of base unit housings.

[0018] FIG.4 schematically depicts a dual temperature sensor to derive core body temperature from heat flux in the base unit according to one or more examples.

[0019] FIG.5A-FIG.5B and FIG.6A-FIG.6B illustrate two examples of base unit housings with single-lead electrocardiogram ("ECG") electrodes incorporated in an adhesive.

[0020] FIG. 7A-FIG. 7B, FIG. 8A-FIG. 8B, and FIG. 9A-FIG. 9B compare adhesive-integrated single-lead, seven-lead, and twelve-lead ECG sensor sets compatible with a housing similar to those in FIG.5A-FIG.5B and FIG.6A-FIG.6B.

[0021] FIG.10A-FIG.10C illustrate a set of "smart cable" expansion modules with sensors that include defibrillation protection and snap onto the adhesive assembly for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques.

[0022] FIG. 11A-FIG.11C illustrate an alternative set of "smart cable" expansion modules with sensors that include defibrillation protection and snap onto the adhesive assembly for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques, along with another alternative base unit or junction box.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0023] FIG. 12A-FIG.12D illustrate an alternative set of "smart cable" expansion modules with sensors that include defibrillation protection and clip onto the adhesive assembly for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques with a single spring-clip and double spring-clips, respectively.

[0024] FIG. 13A-FIG.13C illustrate an alternative set of "smart cable" expansion modules with sensors that include defibrillation protection and attach to the adhesive assembly using double spring-clips, for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques.

[0025] FIG.14A-FIG.14C illustrate an embodiment of an adhesive assembly into which the base unit slides in a direction parallel to the patient's sternum, avoiding excessive pressure against the patient's chest.

[0026] FIG.15A-FIG.15B illustrate a different embodiment of an adhesive assembly into which the base unit slides in a direction parallel to the patient's sternum, avoiding excessive pressure against the patient's chest.

[0027] FIG.16A-FIG.16c illustrate a different embodiment of an adhesive assembly into which the base unit slides in a direction parallel to the patient's sternum, avoiding excessive pressure against the patient's chest.

[0028] FIG.17A-FIG.17C illustrate a different embodiment of an adhesive assembly into which the base unit slides in a direction parallel to the patient's sternum, avoiding excessive pressure against the patient's chest.

[0029] FIG.18 illustrates some modes of communication that may be used by the base unit in a hospital setting.

[0030] FIG.19 illustrates some modes of communication that may be used by the base unit in a non-hospital setting.

[0031] While the disclosed subject matter is susceptible to various modifications and alternative forms, the drawings illustrate specific implementations described in detail by way of example. It should be understood, however, that the description herein of specific examples is not intended to limit that which is claimed to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the appended claims. DETAILED DESCRIPTION

[0032] The present disclosure provides a wearable monitoring platform with an integrated base unit that has a sensor expansion capability to cover any acuity level in hospital and outside-the- hospital settings. The base unit is capable of continuous monitoring of patient physiological dataCustomer No.143770 Attorney Docket No. SIBEL-009PCT such as electrocardiogram (“ECG”), heart rate (“HR”), Body Temp, Activity, location, fall detection, humidity. The wearable monitoring platform provides an easy step-up to intermediate and high acuity monitoring, can measure 1-lead, 7-lead, and 12-lead ECG, body temperature and acoustic data, and will implement state-of-the art algorithms for arrhythmia detection. The wearable monitoring platform furthermore provides a variety of wireless communication modes including pairing and device-location modes; option to use wired power and / or data connections. The wearable monitoring platform also uses a more powerful processor than previous sensors and provides enough battery life for continuous Wi-Fi data transmission.

[0033] Turning now to the drawings, FIG.1 is a schematic block diagram of the electronics for a base unit 100 for the wearable monitoring platform according to one or more examples. FIG.2A- FIG. 2C depict one particular embodiment for a housing 200 of the base unit 100 in FIG. 1 in perspective, side plan, and top plan views, respectively. The housing 200 defines a cavity (not shown) in which the electronic components shown in FIG.1 are disposed.

[0034] The housing 200 more particularly comprises a thicker, or raised, portion 203, a thinner, or lower, portion 206, and an optional port 209. The port 209 may be for expansion and / or charging, for example. The housing 200 is partially flexible and provides a soft encapsulation. In the present context, "partially flexible" means that some parts are more flexible than others, and some of the less flexible parts may be rigid. The housing 200 can be fabricated from multiple materials such as Acrylonitrile butadiene styrene (ABS), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), polycarbonate (PC), and polyetheretherketone (PEEK), Silicon, Thermoplastic Elastomer (TPE)e or Thermoplastic Polyurethane (“TUP”).

[0035] The partial flexibility of the housing 200 lies at least in the thinner portion 206. The thicker portion 203 may, or may not, be flexible as well although the electronics disposed therein may inhibit such flexibility. The partial flexibility of the lower, thinner portion 206 is a function of at least its dimensions and material of construction. The partial flexibility permits a caregiver or the patient to more easily lift that portion of the housing 200 to facilitate removal or maneuvering of the base unit 100 as a whole while also allowing better conformance to anatomical variation which improves comfort

[0036] In general, it is preferred that the base unit 100 be smaller and lighter as opposed to larger and heavier. In one implementation, the overall length of the housing 200 is 50-70 mm, of which the thicker portion 203 comprises 40-55 mm and the thinner portion 206 comprises 10-15 mm. The width in this implementation is 40-55mm and the height of the thicker portion 203 is 6-18 mm. The overall weight of the base unit 100 in this implementation is 50 grams. However, theCustomer No.143770 Attorney Docket No. SIBEL-009PCT dimensions and weight in other dimensions may vary and be greater or lesser than these particular quantifications.

[0037] FIG.3 illustrates several alternative housings 300a-300i for the base unit 100 of FIG.1. Several aspects of these implementations are notable. For example, note the proportionately larger, relative to the housing 200 in FIG.2, lower portions 303 in the housings 300d-300f. The housing 300b, 300c include two raised portions 306 while the housing 300i has two lower portions 303.

[0038] Returning now to FIG.1, it is contemplated by the present disclosure that the basic unit 100 includes electronic components or electronic computing devices operable to receive, transmit, process, store, and / or manage data and information associated with the systems and methods described further herein, which encompasses any suitable processing device adapted to perform computing tasks consistent with the execution of computer-readable instructions stored in memory or computer-readable recording medium.

[0039] To that end, the electronic components may comprise an electronics assembly. The components may comprise an assembly, such that the electronic components may communicate with one another over an internal bus system, such as, by way of example and without limitation, a System on a Chip (“SoC”).

[0040] The electronic components may include a multi-modal plurality of sensors 110. In this context, the term “multi-modal” means that the sensors collect a variety of different types of data. For example, the illustrated embodiments collect three different types of data—patient physiological data, environmental data, and location data. In some embodiments, the collected data may include, by way of example and without limitation, ECG, PPG, heart rate, body temperature, activity, location, and humidity. The illustrated embodiment includes patient physiological sensors, environmental sensors, and location sensors. Other embodiments may use other kinds of sensors in addition to or in lieu of those in the illustrated embodiment. Embodiments will therefore have a variety of sensors that other medical devices do not offer in combination.

[0041] For example, embodiments may include one or more of an ECG sensor through smart cable expansion module(s) connected to the expansion port as described below.

[0042] Dual microphones or other acoustic or audio sensors may be employed, one directed outward to collect environmental noise for noise cancellation and the other directed toward the body for listening to body sounds e.g., lungs and heart. For example, detecting sounds like lung crackling or wheezing, which correlate to, for example, pneumonia, permits the capability of predicting pneumonia with this acoustic data.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0043] An inertial measurement (“IMU”) can be used for respiratory monitoring or for more complex usages such as lung sound detection (e.g., crackling and wheezing in lungs possibly indicating pneumonia).

[0044] A barometer may be used for fall detection and a humidity sensor and an ambient temperature sensor for environmental conditions (if it’s humid the patient is at higher risk for heat stroke).

[0045] Dual temperature sensor(s) having a structure and thermal separation such as shown and discussed below for heat flux measurements and / or core body temperature estimation may be included. So may an ambient temperature sensor to identify environments that pose a risk to health and / or provide real-time baseline correction for the core body temperature algorithm.

[0046] Humidity is important for areas like trigger safety for firefighters. If the patient is at risk of a heatstroke, whether it is humid outside is useful to know because higher humidity presents a higher risk of heatstroke.

[0047] The patient physiological sensors may include, by way of example and without limitation, a single lead electrocardiogram (“ECG”) sensor 103, an auscultation sensor 106, an inertial measurement unit (“IMU”) 124, or some combination thereof. The environmental condition sensors may include, again by way of example and without limitation, a barometer 109, a humidity sensor 112, an ambient temperature sensor 115, a heat flux sensor 118, a noise cancellation microphone 122 or some combination thereof.

[0048] FIG. 4 illustrates the deployment of the basic unit 100 to position the dual temperature sensor(s) 118 for measuring heat flux measurements and / or core body temperature estimation. The sensor 118 include two thermal slugs 400a, 400b and three sensors 403a, 403b, 403c, disposed within the housing 200. Note that, while present, other electronics of the base unit 100 have been omitted from FIG.4 for the sake of clarity. The sensors 403a, 403b, 403c are mounted to a printed circuit board 409. The sensor 188 has a structure that provides structural and thermal separation for the thermal slugs 400a, 400b and three sensors 403a, 403b, 403a. The thermal slug 400a is positioned against the housing 200 to exchange heat with the ambient atmosphere 412 while the thermal slug 400b is positioned to exchange heat with the patient’s epidermis 415.

[0049] The electronics assembly also includes a multi-modal communications interface 121. The term “multi-modal” in this context means that the communications interface permits and facilitates different modes of communication. In some embodiments those modes may include at least a near-field, low power mode; a ubiquitous medium-range mode, a long-range mode such, and a wired mode. However, other embodiments may use more or fewer modes and other types of modes in addition to or in lieu of those disclosed herein.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0050] Different technologies may be used to implement the different technology modes. Candidate technologies include, by way of example and without limitation, high-or low-speed local area wireless such as Wi-Fi; near-field communication (“NFC”); short-range and low-power wireless such as Bluetooth Low-Energy(“BLE”), broadband wireless suitable for telephony such as Long Term Evolution (“LTE”), ultra-wide band (“UWB”) as well as a wired interfaces such as universal serial bus (“USB”). One particular embodiment includes Wi-Fi, BLE, LTE, USB, and also ultra-wideband technologies.

[0051] As shown in FIG. 1, the multi-modal communications interface 121 comprises a wired transceiver 124 and a plurality of wireless transceivers 127. The wireless transceivers 127 may include, for example and without limitation, a low power, power saving transceiver 130; a ubiquitous transceiver 133; a high speed transceiver 136, a long range transceiver 139, and a specialty transceiver 142. Thus, this embodiment employs multiple modes of communications for measurement data transfer including a near-field, preferably low-power mode such as Bluetooth Low Energy (“BLE”) (a / ka / Bluetooth Smart); a ubiquitous medium-range mode such as Wi-Fi; a long-range mode such as Long Term Evolution (“LTE”) or Long Term Evolution Machine Type (“LTE-M”); and wired mode such as Universal Serial Bus (“USB”).

[0052] The multi-modal communications interface 121 can switch between the various modes automatically to use the most suitable one for a given environment in which the base unit 100 is deployed. For example, BLE saves power and can be used when a bedside monitor is in range and Wi-Fi is great if high data transmission is needed or if the device is out of range of the monitor. USB is great for when the base unit 100 is near a patient monitor with which a wired connection may be established and / or when someone wants to charge it. LTE is useful when everything else fails to send emergency alerts. In some embodiments, two or more of the modes may be used simultaneously.

[0053] Besides measured, or sensed or acquired, data, other kinds of data may be exchanged through the multi-modal communications interface 121. Such other kinds of data may include pairing, authentication, or device location information. (Device location may find an additional transceiver such as Ultra-Wide Band ("UWB") transceiver ]useful.). In some embodiments, the UWB functionality enables real-time location tracking of patients within clinical facilities, aiding in workflow optimization and patient safety monitoring.

[0054] The communications disclosed herein occur in real time, or at least in near real time, through multi-mode comm interface 121. As used herein, real time means that the data is transmitted as it is required or retrieved from storage without the need for buffering. Near real time means as near to real time as available computing resources permit.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0055] In some embodiments, the system supports synchronized data capture across multiple sensors using time-alignment protocols to enable derived measures like PAT and PTT.

[0056] Although the communication standards mentioned above are in widespread use, alternative transceivers may be included for modes of communication that are more available in certain use environments or geographical areas, or that may replace these modes in the future. In general, as seen in FIG. 1, communication modes may be chosen for use-case priorities including, but not limited to, power savings, ubiquity / availability, high speed, long range, or specialties such as high security or location discovery.

[0057] Accordingly, the multi-modal communications capability of the disclosed wearable monitoring platform presents a number of advantages over conventional practice. This multi- modal communications model lends versatility to the wearable monitoring platform, permitting it to operate in environments in which not all communications modalities are supported. This capability reduces the chance significantly that important health data is not transmitted due to bad network, out of range, etc. The capability can furthermore be optimized for certain uses. For example, when the patient is not ambulating at all the sensor(s) can be plugged into the monitor all the time. Or, for another example, at home remote patient monitoring the cellular service would be optimal as it would work right away.

[0058] The multi-modal communications capability provides a lot of flexibility in allowing the clinician and patient to adapt to changes in patient mobility without changing the monitor. For example, if a patient is not mobile and is always going to be in bed, the wired USB connection allows for continuous monitoring with high data throughput while keeping the device charged When a patient needs the freedom to move around the room, BLE will give several days of battery life, which could last the whole patient's stay. Low power Wi-Fi capability is for remote patient monitoring where the patient has mobility beyond a single room such as around the whole hospital or their home and there is not a necessity for continuous real time streaming data. The sensor is also able to stream all data in real time with more power consumption and subsequent impact to battery life that is continuously estimated and reported to the clinician. Medical use cases may include in or out of run, in a bathroom, ambulating in a hallway, off the floor, in radiology, if in the event of falls.

[0059] A control unit 150 in the base unit 100 may automatically choose or change communication modes based on the complexity of the measurements, the desired continuity of measurements, particular needs for high speed or high precision, and the availability of power. In areas with less or older infrastructure, the base unit may be adapted to use the communicationCustomer No.143770 Attorney Docket No. SIBEL-009PCT modes that are locally available. As communication technology advances, the base unit may be adapted to use new modes and protocols as they are adopted in various settings.

[0060] The control unit 150 may also perform certain analyses on the acquired data for a variety of reasons, such as issuing alarms, and conditioning data. For example, the control unit 150 may execute edge artificial intelligence (“AI”) algorithms on-board the sensor for analyzing measured data. The control unit 150 may co-operate with AI and traditional rule-based algorithms that reside on a patient monitor, server, or other networked processor. The algorithm may recognize both lethal and non-lethal arrhythmias such as Ventricular Fibrillation, Ventricular Tachycardia, Supraventricular Tachycardia, Bradycardia, Atrial fibrillation, Tachycardia, Supraventricular Tachycardia, Ventricular bigeminy, Premature ventricular contraction, Ventricular RUN, Accelerated Idioventricular Rhythm, Ventricular Couplet, Pause, Asystole, Successive premature ventricular contraction, Accelerated idioventricular rhythm, Couplets, and Artifacts. It may also derive interval metrics such as ST Segment, QT / QTc intervals, and HRV (heart rate variability) from ECG traces. Also, interval metrics important for telemetry, such as ST-segment, QT / QC interval, etc. will be monitored and transmitted.

[0061] The control unit 150 includes some kind of processor-based resource and some kind of memory. In the illustrated embodiment, the processor-based resource is a controller 153 and the memory is a removable, non-volatile memory 156 (e.g., a secure digital (“SD”) card). The memory 156 is encoded with instructions 159 that, when executed by the controller 153 imparts the programmed functionality of the basic unit 100 described herein.

[0062] Although the control unit 150 of the illustrated embodiment employs a controller, other types of processor-based resources may be employed in other embodiments. For example, the processor-based resource may be, but is not limited to, a central processing unit (“CPU”), a hardware microprocessor, a multi-core processor, a single core processor, a field programmable gate array (“FPGA”), an application specific integrated circuit (“ASIC”), a digital signal processor (“DSP”), microprocessor, microcontroller, electrical programmable read only memory (“EPROM”), etc. or other similar processing device capable of executing any type of instructions, algorithms, or software for controlling the operation of the base unit 100. Some embodiments may employ multiple, complementary processors in chipsets, such as a microprocessor and a math co- processor.

[0063] Similarly, the memory may be realized in alternative implementations. The memory may be volatile (such as random access memory (“RAM”)), non-volatile (such as read-only memory (“ROM”), flash memory, etc.), or some combination of the two. The memory may be on-board orCustomer No.143770 Attorney Docket No. SIBEL-009PCT off-board, may be a separate device or cache. Those in the art having the benefit of this disclosure may realize still other implementations.

[0064] As discussed above, the control unit 150 may be a system-on-chip (“SoC”) controlling all the sensors and transceivers. The control unity 150 may employ advanced processors such as multi-core ARM Cortex-M33 processors, RISC-V coprocessors, and other processors with suitable specifications to control multiple wireless protocols as well as configuring peripheral sensors, and moreover it allows the extra computing power for machine learning (“ML”) edge computing. The SoC is the central unit in the housing. A removable and replaceable memory 156, such as an SD card, may also be included in the housing.

[0065] Still referring to FIG. 1, the base unit 100 may also include one or more ports 160 or sockets. In Fig.1, the base unit is shown with three of the optional ports 160, an expansion port 163, a charging socket 166, and a user interface (“UI”) port 169. The expansion port 163 may be used in conjunction with smart cable expansion modules (not shown) as discussed further below. The charging socket 166 may be used to charge batteries or other portable power sources (not shown). The UI port 169 may be used to interface with UI devices such as lights, sound, and haptic responses. Some embodiments may omit such ports altogether.

[0066] In some embodiments, one or more of these functionalities may be combined into a single socket or port. This may be desirable for size and / or weight savings. Accordingly, some may have more or fewer ports / sockets than are shown in FIG.1. For example, FIG.2 only shows a single port 209. Some embodiments may omit such ports altogether.

[0067] FIG.5A, FIG.5B and FIG.6A, FIG.6B illustrate alternative embodiments of the base unit 100 alternative to that of FIG. 1 in disassembled views. These figures also, in conjunction with FIG. 7A, FIG. 7B, also illustrate a manner in which the footprint of the basic unit 100 may be expanded as alluded to above. Referring now to FIG. 5A and FIG. 6A, there are shown two separate embodiments, a basic unit 500 in FIG.5A and a basic unit 600 in FIG.6A. The two basic units 500, 600 differ primarily in their dimensions , basic unit 500 being squatter and basic unit 600 being longer. Notably, each has a respective raised portion 503, 603 that is encompassed by a respective thinner portion 506, 606.

[0068] FIG. 5B, FIG. 6B depict electrodes 509, 609 which are integrated with the consumable adhesive, that interface with the base units 500, 600, respectively, as parts of respective single lead ECG sensors, e.g., the single-lead ECG sensor 103 in FIG.1. The electrode 509 is shown in a bottom view in which an adhesive 515, also indicated by cross-hatching, by which the electrode may be affixed to the patient is shown. The electrode 609 is shown in a top view in which the adhesive on the bottom surface of the electrode 609 is obscured. The terms “top” andCustomer No.143770 Attorney Docket No. SIBEL-009PCT “bottom” are defined herein relative to the patient’s skin, with the “bottom” being most proximal to the patient’s skin that the “top” being most distal therefrom. Note that, with snap electrodes, there may not be a separate smart cable but, instead, a single adhesive patch with a plug-in.

[0069] The electrode 509 includes two detectors 512a, 512b that, when affixed to the patient, define the single lead. Similarly, the electrode 609 includes two detectors 612a, 612b that, when affixed to the patient, define the single lead. The detectors 512a, 512b and 612a, 612b may be incorporated into the base adhesive with an electrical interface.

[0070] Fig. 7A shows an assembled base unit 700 including a single-lead ECG electrode 703. Note the shape of the body for the base unit 700 is more triangular than the base units 500, 600 in FIG.5A, FIG.6A. FIG.7B shows the assembled base unit applied to the chest of a patient 706, the electrodes 712 (right atrial, or “RA” and left atrial, or “LA”) defining a single lead therebetween.

[0071] The presently disclosed base units (e.g., base units 100, 500, 600, 700 shown in FIG.1, FIG. 5A, FIG. 6A, FIG. 7A, respectively) may also instead include seven-lead and twelve lead ECG sets. FIG.8A shows a modular extension 800 implementing a seven-lead ECG setup. As used herein, a “modular extension” may be an adhesive strip such as the electrodes 509, 609, 703 in FIG.5A, FIG.6A, and FIG.7A, respectively, or a cable, or a smart cable. In this case, the modular extension is a smart cable, such as will be discussed further below.

[0072] The modular extension 800 includes a cable 803 and three detectors 806, the three detectors 806 defining seven leads when applied to the patient 809 in FIG. 8B. The cable 803 terminates in a connector 812 by which the modular extension 800 may be electrically and operably connected to the body of the base unit 700. The connector 812 may implement any suitable connector, preferable one subject to a standard, such as USB-micro or USB-C. More particularly, the connector 812 may electrically connect to an expansion port on the base unit 700, e.g., the expansion port 160 shown in FIG.1.

[0073] FIG. 9A shows a modular extension 900 implementing a twelve-lead ECG setup. The modular extension 900 includes a cable 903 and three detectors 906, the three detectors 906 defining twelve leads when applied to the patient 809 in FIG.8B. The cable 803 terminates in a connector 812 by which the modular extension 800 may be electrically and operably connected to the body of the base unit 700. The connector 812 may implement any suitable connector, preferable one subject to a standard, such as USB-micro or USB-C. More particularly, the connector 812 may electrically connect to an expansion port on the base unit 700, e.g., the expansion port 160 shown in FIG.1.

[0074] Some embodiments of the modular extension may employ a smart cable and / or snap connectors. FIG.10A-FIG.10C illustrate a set of "smart cable" expansion modules 1000a-1000cCustomer No.143770 Attorney Docket No. SIBEL-009PCT with detectors 1003 that include defibrillation protection and snap onto the adhesive assembly 1006 for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques. In the illustrated embodiments, different cables 1009 serve different functions. The cables 1009 going to electrodes are ECG cables. The central cable 1009 going to the device is a data and power cable. The same applies to the cables 1109 in FIG. 11A-FIG.11C.

[0075] The expansion modules may include configurations for additional sensing modalities such as near-infrared spectroscopy (“NIRS”), SpO₂, photoplethysmography (“PPG”), pulse arrival time (“PAT”), and pulse transit time (“PTT”) for cuffless blood pressure. Each cable may be designed with a modular architecture, allowing combination of various sensor types into a single cable. Additional smart cables may include those configured for fetal ECG, electroencephalography (“EEG”), photoplethysmography (“PPG”), pulse transit time (“PTT”)-based blood pressure, and others. These cables can be developed with modular combinations of sensing modalities, offering customizable options based on clinical or field use.

[0076] FIG. 10A-FIG. 10C provide for a single-lead expansion module 1000a, a seven-lead expansion module 1000b, and a twelve-lead expansion module 1000c, respectively. Each of the expansion modules 1000a-1000c includes several cables 1009, a junction box 1012, and an electrical connector 1015. A separate cable 1018 may be used to charge the junction box 1012, which implies that there are at least two separate expansion ports on the basic unit. The cables 1009 are, in the illustrated embodiment, ECG cables. The junction box in some embodiments includes processing capability, allowing localized execution of algorithms such as signal conditioning, feature extraction, and edge AI analysis independent of the base unit or external monitor. The connectors may include analog, digital, and power lines, and may be implemented using snaps, clips, or custom mechanical interfaces. Defibrillation protection may be integrated either into the connector or embedded within the smart cable housing itself, allowing flexibility in product design.

[0077] FIG.11A-FIG.11C illustrate an alternative set of "smart cable" expansion modules 1100a- 1100c with detectors 1103 that include defibrillation protection and snap onto or into the adhesive assembly or pad 1106 for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques, along with another alternative base unit or junction box. These may include configurations for additional sensing modalities such as near- infrared spectroscopy (NIRS), SpO₂, photoplethysmography (PPG), pulse arrival time (PAT), and pulse transit time (PTT) for cuffless blood pressure. Each cable may be designed with a modular architecture, allowing combination of various sensor types into a single cable. The junction box inCustomer No.143770 Attorney Docket No. SIBEL-009PCT some embodiments includes processing capability, allowing localized execution of algorithms such as signal conditioning, feature extraction, and edge AI analysis independent of the base unit or external monitor.

[0078] FIG. 11A-FIG. 11C provide for a single-lead expansion module 1100a, a seven-lead expansion module 1100b, and a twelve-leave expansion module 1100c, respectively. Each of the expansion modules 1100a-1100c includes several cables 1109, and a coupling 1112 and / or a basic unit 1115. The cables 1109 are, in the illustrated embodiment, ECG cables. Note the expansion port 1118 in the disassembled base unit 1115 in FIG.11C. The junction box in some embodiments includes processing capability, allowing localized execution of algorithms such as signal conditioning, feature extraction, and edge AI analysis independent of the base unit or external monitor.

[0079] As noted, the expansion modules of FIG. 10A-10C and FIG. 11A-FIG. 11C provide the stated number of leads equal to or less than the conventional number of electrodes when using advanced processing techniques. For example, some embodiments may omit the right leg. So, for three-lead ECG, only two sensors, for up to seven leads, embodiments only use four electrodes. And then, for all the way to the twelve-lead, only nine detectors.

[0080] FIG. 12A-FIG. 12D illustrate an alternative set of "smart cable" expansion module 1200 with sensors 1203 on an adhesive patch 1206 that include defibrillation protection and clip onto the adhesive assembly for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques with a single spring-clip 1209. The expansion module 1200 is best shown in FIG. 12D, wherein the sensors 1203 are shown on a cable 1212. The electrical connector 1215 with which the cable 1212 terminates on one end connects to a junction box (not shown). The single spring-clip 1209 is best shown in the perspective top view of FIG.12A in a side view in FIG. 12C. FIG.12B is a sectioned top, plan view of the single spring-clip 1209 showing the defibrillation protection circuit 1218. Other embodiments include using snap electrode clips, hook electrode clips, banana plugs, or clips for tab electrodes. Any electrode interface can be incorporated into the design.

[0081] FIG. 13A-FIG.13C illustrate an alternative set of "smart cable" expansion modules with sensors 1300 that include defibrillation protection and attach to the adhesive assembly using double spring-clips 1306, for multi-lead ECG using equal to or less than the conventional number of electrodes when using advanced processing techniques. A double spring-clip 1306 is shown in a top, perspective view in FIG.13A and in a side view in FIG.13C. FIG.13B is a sectioned top, plan view of the single spring-clip 1209 showing the defibrillation protection circuit 1318.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0082] Referring now collectively to FIG. 12A-FIG. 12D and FIG. 13A-FIG. 13C, the two expansion modules shown therein will have the same layout as the expansion modules in FIG. 10A-FIG. 10C and FIG. 11A-FIG. 11C except that instead of snap fastening the probes to the contact electrodes, there will be clips. The expansion modules integrate defibrillation protection circuits in the ECG electrode connectors. This circuit includes a TVS diode and energy dissipation resistor intended to protect the device from damage without impacting the defibrillation energy. By default, the expansion modules will therefore have a defib protection inside of the expansion cable itself allowing for a reduced size of the main unit and cable module. The double spring-clip sensor connectors of FIG.13A-FIG.13C are pressed or snapped on like a snap electrode but are disconnected by compressing the two opposing buttons. A similar mechanism for connecting and disconnecting applies to the single spring-clips in FIG..12A-FIG.12D. Alternate embodiments are also considered, such as integrating the defibrillation protection into snap electrodes, clip electrodes, banana plugs, custom mechanical interfaces, or even directly into the cable assembly itself allowing flexibility in product design.

[0083] Alternatively, the adhesive may just be an adhesive without anything more complicated. FIG. 14A-FIG. 14C, FIG. 15A-FIG. 15B, AND FIG. 16A-FIG. 16D illustrate this alternative approach for the adhesive. In particular, this approach permits affixation of the basic unit to a patient without having to press it onto the patient’s body. For example, one might not wish to press to firmly on if they have a wound on their chest or if they just came out of surgery. The entire assembly, including the

[0084] Turning first to FIG.14A-FIG.14C, FIG.14A illustrates the assembly of a basic unit 1400 into a sleeve 1410 to create a wearable unit 1406. The wearable unit 1406 is maintained assembled by a vacuum created by inserted the basic unit 1400 into the sleeve 1410 by the fit of the sleeve 1410. The sleeve 1410 includes one or more rails, more particularly a U-shaped rail 1411. The basic unit 1400, as shown in the side view of FIG.14B, includes a protuberance or an elevated point 1413, that seats in the aperture 1425 in the floor 1426 when the basic unit 1400 is assembled into the sleeve 1410. The floor 1426 of the sleeve 1410 has an adhesive (not shown) applied to the back surface of the floor 1426.

[0085] The assembled wearable unit 1426 is applied to the patient 1409 as shown in FIG.14C. The basic unit 1400 includes a photoplethysmography (“PPG”) sensor therein positioned in the protuberance 1413, shown in FIG.14B, that seats in the aperture 1425 as discussed above. The basic unit 1400 then monitors the patient 1409’s PPG when applied as shown in FIG .14C. Note that, in FIG.14C, the wearable unit 1406 is shown including not only the basic unit 1400 and the sleeve 1410, but also two modular expansions 1420, 1421 for ECG monitoring.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0086] FIG.15A-FIG.15B illustrate a variant on this approach. FIG.15A conceptually depicts the assembly of a basic unit 1500 into a sleeve 1505 to create a wearable unit 1510. The sleeve 1505 may be a part of a consumable adhesive pad 1506 that includes two modular expansions 1507, 1508. The sleeve 1505 also includes one or more rails, an arc-shaped rail 1511 in this case. The basic unit 1500 slides into the sleeve 1505 from the top of the sleeve 1505 and is positioned by the rail 1511.

[0087] FIG.15B shows the wearable unit 1510 affixed to a patient 1525 with modular extensions 1507, 1508, and1530. Note that the modular extensions 1507, 1508 are positioned by the adhesive pad 1506 when applied while the detectors of the modular extension 1530 are hand positioned by a caregiver. The wearable unit 1510 may be used in this example for monitoring a number of patient physiological parameters and particularly for ECG monitoring.

[0088] FIG. 16A-FIG. 16C illustrate a second variant on this approach. FIG. 16A depicts the assembly of a basic unit 1600 into a sleeve 1605 to create a wearable unit 1610. The basic unit 1600 slides into the sleeve 1605 from the top of the sleeve 1605. The sleeve 1605 includes one or more rails, a U-shaped rail 1611, and an aperture 1625 in the floor 1626 thereof. The basic unit 1600, as shown in the side view of FIG.16B, includes a PPG sensor (not shown) positioned in a first portion 1613 that seats in the aperture 1625 in the floor 1626 when the basic unit 1600 is assembled into the sleeve 1610. The floor 1626 of the sleeve 1610 has an adhesive (not shown) applied to the back surface of the floor 1626.

[0089] The assembled wearable unit 1626 is applied to the patient 1609 as shown in FIG.16C. The basic unit 1600 includes a photoplethysmography (“PPG”) sensor therein positioned in the protuberance 1613, shown in FIG.16B, that seats in the aperture 1625 as discussed above. The basic unit 1600 then monitors the patient 1609’s PPG when applied as shown in FIG.16C.

[0090] The basic unit 1600 also houses a battery (not shown) disposed in a middle portion 1630 thereof and temperature sensors (not shown) in a portion 1633 opposite the first portion 1613. Note that, in FIG.16C, the wearable unit 1606 is shown including not only the basic unit 1600 and the sleeve 1610, but also three modular expansions 1620, 1621, 1622. The modular expansions 1620, 1621 comprise housings having sensors disposed therein connected to the basic unit 1600 via cables 1635 and expansion ports (not shown). The modular expansion 1622 comprises a single detector 1638 on a cable 1635 also communicating with the basic unit 1600 via a cable 1635.

[0091] FIG.17A-FIG.17C illustrate a variation on the example of FIG.16A-FIG.16A. In this case, the sleeve 1605 is part of an adhesive pad 1700, shown in FIG. 17A. The adhesive pad has adhesive (not shown) on the back of the pad and adhesive locations 1703, 1704, 1705, and 1706Customer No.143770 Attorney Docket No. SIBEL-009PCT to hold the expansion module 1621, basic unit 1600, detector 1638, and expansion module 1620, respectively, in position. The entire assembly can then be positioned on the patient 1710 as shown in FIG.17C.

[0092] In each of the smart cable expansion modules disclosed above, in some implementations, the sensor connectors on the smart cables comply with the IPX7 standard promulgated by the International Electrotechnical Commission (“IEC”). These expansion modules are therefore resistant to immersion in 1m of water for up to 30 minutes. This may influence the design of the implicated connections. The base unit, smart cables and other expansion modules may also comply with the IEEE 11073 SDC (service device connectivity) standard and similar regulations Note that not all embodiments are IPX7 or SDC compliant and that this may be an implementation specific detail.

[0093] FIG.18 illustrates some modes of communication that may be used by the base unit in a hospital setting. Two scenarios are presented. In the first scenario 1800, the patient 1805 is ambulating through the hospital and the wearable platform 1810 communicates with a portable monitor 1815 using, for example, Bluetooth. (In the illustrated embodiment, the portable monitor 1815 may be, for example, a smart phone with an application through which the smart phone communicates with the wearable platform 1810.) The wearable platform 1815 concurrently communicates a centralized monitoring station 1820 by Wi-Fi.

[0094] The second scenario 1825 is a bedside scenario in which the patient 1810 is lying or resting in bed. A bedside monitor 1830 is positioned, as the term suggests, at the patient’s bedside. The wearable platform 1820 communicates with the bedside monitor 1830 by wired USB and, again, concurrently with the centralized monitoring station 1820 by Wi-Fi.

[0095] FIG.19 illustrates some modes of communication that may be used by the base unit in a hospital setting. Again, two scenarios are presented. In a first scenario 1900, a patient 1905 is in their home. The wearable platform 1910 communicates with a portable monitor 1915 by Bluetooth and concurrently with the centralized monitoring station 1920 over Wi-Fi. In a second scenario 1925, the patient 1905 exits the home and is somewhere outside. In this scenario, the wearable platform 1905 still communicates with the portable monitor 1915 over Bluetooth. However, the wearable platform 1905 and portable monitor 1915 concurrently communicate with the centralized monitoring station 1920 using LTE-M and BLE, respectively, in order to maintain communications for alarms and alerts.

[0096] In some embodiments, the wearable platform disclosed herein is not just a sensor, for example, telemetry or ICU. The wearable platform may be a high acuity sensor such that it is usable for patients that are at higher risk of complications, and potentially severe complications.Customer No.143770 Attorney Docket No. SIBEL-009PCT The wearable platform in these embodiments can cover several areas in the hospital, and also outside of the hospital, that are considered high acuity. The wearable platform is very versatile and could work even in a place, like a military zone where there's no wireless communications except for cellular service. So, in a very low resource setting it will work, but even up to the critical care level.

[0097] The wearable platform can therefore be optimized for certain uses through sensor selection and the use expansion modules. Expansion modules can be used for many capabilities, such as a step-up from single-lead ECG to seven-lead or twelve-ECG, PPG and / or blood oxygen saturation (SpO2), continuous core body temperature, etc. Performance may be optimized for clinical use and also capable of remote patient monitoring in, for example, a home setting. The wearable platform may even bring full or partial performance in low-resource settings such as combat, emergency response, or disaster relief.

[0098] The wearable platform is reusable, rechargeable, and sustainable by reducing e-waste and cost per patient. It furthermore integrates directly with centralized monitoring stations, bedside monitors, electronic health records, etc. The wearable platform includes an unique group of base sensor capabilities (ECG, Body Temp, Auscultation) and expansion port(s) facilitate multi-role workflow adaptability and add-on accessories to avoid obsolescence. The selection of base sensor capabilities may provide monitoring fundamentals such as Lead I ECG; heart and lung auscultation; vital sign parameters, such as heart rate (“HR”), respiration rate (“RR”), temperature, and activity tracking (e.g., step count, fall detection, body position).

[0099] Accordingly, in a first embodiment, an integrated base unit for use in a wearable monitoring platform, the integrated base unit comprises a multi-modal plurality of sensors; a multi-modal communications interface; a controller; a memory, and a partially pliable housing in which the sensors, communications interface, controller, and memory are disposed. A set of instructions resides on the memory that, when executed by the controller, transmit through the multi-modal communications interface multi-modal data acquired through the sensors.

[0100] In a second embodiment, in the integrated base unit of the first embodiment, the multi-modal plurality of sensors includes patient physiological sensors and environmental condition sensors.

[0101] In a third embodiment, in the integrated base unit of the second embodiment, the patient physiological sensors include Electrocardiogram (“ECG”) sensors, an auscultation sensor, or some combination thereof.

[0102] In a fourth embodiment, in the integrated base unit of the second embodiment, wherein the environmental sensors include a barometer, a humidity sensor, an ambientCustomer No.143770 Attorney Docket No. SIBEL-009PCT temperature sensor, a heat flux sensor for core body temp estimation, a PPG sensor, or some combination thereof.

[0103] In a fifth embodiment, in the integrated base unit of the first embodiment, the plurality of sensors includes an inertial measurement unit (“IMU”).

[0104] In a sixth embodiment, in the integrated base unit of the first embodiment, wherein the multi-modal communications interface includes wired transceivers and wireless transceivers.

[0105] In a seventh embodiment, the integrated base unit of the first embodiment further comprises one or more ports.

[0106] In an eighth embodiment, in the integrated base unit of the first embodiment, the communications interface includes a wired transceiver, a wireless transceiver, or a combination thereof.

[0107] In a ninth embodiment, in the integrated base unit of the first embodiment, the partially pliable housing comprises a raised portion and a lower portion.

[0108] In a tenth embodiment, the integrated base unit of the first embodiment further comprises one or more ports with provisions for electrodes, power and data.

[0109] In an eleventh embodiment, a medical monitoring system comprises a base unit and a patient monitor. The base unit comprises a partially flexible housing with a soft encapsulation, a coupling for wired data, a wireless transmitter operable in, and switchable between, a plurality of communication modes, an electrical sensor, a first audio sensor directed at the environment to facilitate noise cancellation, a second audio sensor directed toward a wearer’s body, a sensor for acceleration and spatial orientation, an ambient pressure sensor, a humidity sensor, an ambient temperature sensor, a heat-flux core body temperature sensor, a coupling for an expansion module, a base-unit processor, and a base-unit controller. The patient monitor comprises a receiver for the sensor data and at least one of a monitor processor, a monitor memory, a monitor visual output, and a monitor audio output.

[0110] In a twelfth embodiment, the system of the eleventh embodiment further comprises an ECG algorithm executable on at least one of the base-unit processor, an expansion cable module processor, and the monitor processor to recognize arrhythmias and measure interval metrics in sensed ECG data.

[0111] In a thirteenth embodiment, in the system of the twelfth embodiment the ECG algorithm executable on the base-unit processor comprises edge artificial intelligence.

[0112] In a fourteenth embodiment, the system of the eleventh embodiment further comprises an expansion module in the form of a smart cable that, when coupled to the expansion- module coupling, adds new or expanded sensing capability to the base unit.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0113] In a fifteenth embodiment, in the system of fourteenth embodiment, the smart cable comprises a number of ECG probes equal to a traditional number of ECG leads minus one when right leg drive is not needed.

[0114] In a sixteenth embodiment, in the system of the fourteenth embodiment, the smart cable comprises a number of ECG probes fewer than the standard number where the additional channels are generated by an algorithm.

[0115] In a seventeenth embodiment, in the system of the fourteenth embodiment, the smart cable comprises a number of ECG probes fewer than the standard number where the additional channels are generated by an algorithm.

[0116] In an eighteenth embodiment, in the system of the eleventh embodiment, the plurality of communication modes comprises ultra-wide bandwidth (“UWB”) and the patient monitor is programmed to use UWB to discover a location of the base unit.

[0117] In a nineteenth embodiment, a wearable base unit for medical monitoring, comprises a partially flexible housing with a soft encapsulation, a coupling for wired data, a wireless transmitter operable in, and switchable between, a plurality of communication modes, an electrical sensor, a first audio sensor directed at the environment to facilitate noise cancellation, a second audio sensor directed toward a wearer’s body, a sensor for acceleration and spatial orientation, an ambient pressure sensor, a humidity sensor, an ambient temperature sensor, a heat-flux core body temperature sensor, a coupling for an expansion module, a base-unit processor, and a base-unit controller.

[0118] In a twentieth embodiment, the wearable base unit of the nineteenth embodiment further comprises an ECG analysis algorithm executable on the base-unit processor and using edge artificial intelligence to recognize arrhythmias and measure interval metrics in sensed ECG data.

[0119] In a twenty-first embodiment, in the wearable base unit of the nineteenth embodiment, the housing is partially flexible in a flap portion that extends outward from a bottom surface of the housing that contacts the wearer's epidermis.

[0120] In a twenty-second embodiment, in the wearable base unit of the nineteenth embodiment, a total weight of the base unit is between 15 and 51 g.

[0121] In a twenty-third embodiment, a smart cable comprises a probe removably attachable to an adhesive skin-contact pad by a snap or a clip, a defibrillation protection circuit inside the cable, electrode, or cable module, a data coupling for exchanging data with a base unit, a monitor, or another smart cable, and a power coupling for drawing power from the base unit or from an external power source.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0122] In a twenty-fourth embodiment, the smart cable of the twenty-third embodiment further comprises a plurality of ECG probes, wherein the total number of ECG probes coupled to the base unit is equal to a standard number of ECG leads minus one when there is no Right Leg Drive required.

[0123] In a twenty-fifth embodiment, in the smart cable of the twenty-third embodiment, the probe comprises one of a PPG probe, a pulse oximeter probe, an electroencephalogram probe, and a core body temperature probe.

[0124] In a twenty-sixth embodiment, an integrated base unit for use in a wearable monitoring platform is substantially as described and shown.

[0125] In a twenty-seventh embodiment, a medical monitoring system is substantially as described and shown.

[0126] In a twenty-eighth embodiment, a wearable base unit for medical monitoring is substantially as described and shown.

[0127] In a twenty-eighth embodiment, a smart cable is substantially as described and shown.

[0128]

[0129] Expressions such as “include” and “may include” which may be used in the present disclosure denote the presence of the disclosed functions, operations, and constituent elements, and do not limit the presence of one or more additional functions, operations, and constituent elements. In the present disclosure, terms such as “include” and / or “have”, may be construed to denote a certain characteristic, number, operation, constituent element, component, or a combination thereof, but should not be construed to exclude the existence of or a possibility of the addition of one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0130] As used herein, the article “a” is intended to have its ordinary meaning in the patent arts, namely “one or more.” Herein, the term “about” when applied to a value generally means within the tolerance range of the equipment used to produce the value, or in some examples, means plus or minus 10%, or plus or minus 5%, or plus or minus 1%, unless otherwise expressly specified. Further, herein the term “substantially” as used herein means a majority, or almost all, or all, or an amount with a range of about 51% to about 100%, for example. Moreover, examples herein are intended to be illustrative only and are presented for discussion purposes and not by way of limitation.

[0131] As used herein, to "provide" an item means to have possession of and / or control over the item. This may include, for example, forming (or assembling) some or all of the item fromCustomer No.143770 Attorney Docket No. SIBEL-009PCT its constituent materials and / or, obtaining possession of and / or control over an already-formed item.

[0132] Unless otherwise defined, all terms including technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. In addition, unless otherwise defined, all terms defined in generally used dictionaries may not be overly interpreted. In the following, details are set forth to provide a more thorough explanation of the embodiments. However, it will be apparent to those skilled in the art that embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form or in a schematic view rather than in detail in order to avoid obscuring the embodiments. In addition, features of the different embodiments described hereinafter may be combined with each other, unless specifically noted otherwise. For example, variations or modifications described with respect to one of the embodiments may also be applicable to other embodiments unless noted to the contrary.

[0133] Further, equivalent or like elements or elements with equivalent or like functionality are denoted in the following description with equivalent or like reference numerals. As the same or functionally equivalent elements are given the same reference numbers in the figures, a repeated description for elements provided with the same reference numbers may be omitted. Hence, descriptions provided for elements having the same or like reference numbers are mutually exchangeable.

[0134] It will be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[0135] In the present disclosure, expressions including ordinal numbers, such as “first”, “second”, and / or the like, may modify various elements. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the sequence and / or importance of the elements. The above expressions are used merely for the purpose of distinguishing an element from the other elements. For example, a first box and a second box indicate different boxes, although both are boxes. For further example, a first element could be termed a second element, and similarly, a second element could also be termed a first element without departing from the scope of the present disclosure.Customer No.143770 Attorney Docket No. SIBEL-009PCT

[0136] Use of the phrases “capable of,” “capable to,” “operable to,” or “configured to” in one or more embodiments, refers to some apparatus, logic, hardware, and / or element designed in such a way to enable the use of the apparatus, logic, hardware, and / or element in a specified manner.

[0137] Use of the phrase “exceed” in one or more embodiments, indicates that a measured value could be higher than a pre-determined threshold (e.g., an upper threshold), or lower than a pre-determined threshold (e.g., a lower threshold). When a pre-determined threshold range (defined by an upper threshold and a lower threshold) is used, the use of the phrase “exceed” in one or more embodiments could also indicate a measured value is outside the pre- determined threshold range (e.g., higher than the upper threshold or lower than the lower threshold).

[0138] The subject matter of the present disclosure is provided as examples of apparatus, systems, methods, circuits, and programs for performing the features described in the present disclosure. However, further features or variations are contemplated in addition to the features described above. It is contemplated that the implementation of the components and functions of the present disclosure can be done with any newly arising technology that may replace any of the above-implemented technologies.

[0139] Various modifications to the disclosure will therefore be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the spirit or scope of the present disclosure. Throughout the present disclosure the terms “example,” “examples,” or “exemplary” indicate examples or instances and do not imply or require any preference for the noted examples. Thus, the present disclosure is not to be limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed.

Claims

Customer No.143770 Attorney Docket No. SIBEL-009PCT CLAIMS WHAT IS CLAIMED IS:

1. An integrated base unit for use in a wearable monitoring platform, the integrated base unit comprising: a multi-modal plurality of sensors; a multi-modal communications interface; a controller; a memory on which resides a set of instructions that, when executed by the controller, transmits through the multi-modal communications interface multi-modal data acquired through the sensors; and a partially pliable housing in which the sensors, communications interface, controller, and memory are disposed.

2. The integrated base unit of claim 1, wherein the multi-modal plurality of sensors includes patient physiological sensors and environmental condition sensors.

3. The integrated base unit of claim 2, wherein the patient physiological sensors include Electrocardiogram (“ECG”) sensors, an auscultation sensor, or some combination thereof.

4. The integrated base unit of claim 2, wherein the environmental sensors include a barometer, a humidity sensor, an ambient temperature sensor, a heat flux sensor for core body temp estimation, a PPG sensor, or some combination thereof.

5. The integrated base unit of claim 1, wherein the plurality of sensors include an inertial measurement unit (“IMU”).

6. The integrated base unit of claim 1, wherein the multi-modal communications interface includes wired transceivers and wireless transceivers.

7. The integrated base unit of claim 1, further comprising one or more ports.

8. The integrated base unit of claim 1, wherein the communications interface includes a wired transceiver, a wireless transceiver, or a combination thereof.Customer No.143770 Attorney Docket No. SIBEL-009PCT 9. The integrated base unit of claim 1, wherein the partially pliable housing comprises a raised portion and a lower portion.

10. The integrated base unit of claim 1, further comprising one or more ports with provisions for electrodes, power and data.

11. A medical monitoring system, comprising: a base unit comprising: a partially flexible housing with a soft encapsulation; a coupling for wired data; a wireless transmitter operable in, and switchable between, a plurality of communication modes; an electrical sensor; a first audio sensor directed at the environment to facilitate noise cancellation; a second audio sensor directed toward a wearer’s body; a sensor for acceleration and spatial orientation; an ambient pressure sensor; a humidity sensor; an ambient temperature sensor; a heat-flux core body temperature sensor; a coupling for an expansion module; a base-unit processor, and a base-unit controller; and a patient monitor comprising: a receiver for the sensor data; and at least one of a monitor processor, a monitor memory, a monitor visual output, and a monitor audio output.

12. The system of claim 11, further comprising an ECG algorithm executable on at least one of the base-unit processor, an expansion cable module processor, and the monitor processor to recognize arrhythmias and measure interval metrics in sensed ECG data.

13. The system of claim 12, wherein the ECG algorithm executable on the base-unit processor comprises edge artificial intelligence.Customer No.143770 Attorney Docket No. SIBEL-009PCT 14. The system of claim 11, further comprising an expansion module in the form of a smart cable that, when coupled to the expansion-module coupling, adds new or expanded sensing capability to the base unit.

15. The system of claim 14, wherein the smart cable comprises a number of ECG probes equal to a traditional number of ECG leads minus one when right leg drive is not needed.

16. The system of claim 14, wherein the smart cable comprises a number of ECG probes fewer than the standard number where the additional channels are generated by an algorithm.

17. The system of claim 14, wherein the smart cable comprises a number of ECG probes fewer than the standard number where the additional channels are generated by an algorithm.

18. The system of claim 11, wherein the plurality of communication modes comprises ultra- wide bandwidth (“UWB”), and wherein the patient monitor is programmed to use UWB to discover a location of the base unit.

19. A wearable base unit for medical monitoring, comprising: a partially flexible housing with a soft encapsulation; a coupling for wired data; a wireless transmitter operable in, and switchable between, a plurality of communication modes; an electrical sensor; a first audio sensor directed at the environment to facilitate noise cancellation; a second audio sensor directed toward a wearer’s body; a sensor for acceleration and spatial orientation; an ambient pressure sensor; a humidity sensor; an ambient temperature sensor; a heat-flux core body temperature sensor; a coupling for an expansion module; a base-unit processor; and a base-unit controller.Customer No.143770 Attorney Docket No. SIBEL-009PCT 20. The wearable base unit of claim 19, further comprising an ECG analysis algorithm executable on the base-unit processor and using edge artificial intelligence to recognize arrhythmias and measure interval metrics in sensed ECG data.

21. The wearable base unit of claim 19, wherein the housing is partially flexible in a flap portion that extends outward from a bottom surface of the housing that contacts the wearer's epidermis.

22. The wearable base unit of claim 19, wherein a total weight of the base unit is between 15 and 51 g.

23. A smart cable, comprising: a probe removably attachable to an adhesive skin-contact pad by a snap or a clip; a defibrillation protection circuit inside the cable, electrode, or cable module; a data coupling for exchanging data with a base unit, a monitor, or another smart cable; and a power coupling for drawing power from the base unit or from an external power source.

24. The smart cable of claim 23, further comprising a plurality of ECG probes, wherein the total number of ECG probes coupled to the base unit is equal to a standard number of ECG leads minus one when there is no Right Leg Drive required.

25. The smart cable of claim 23, wherein the probe comprises one of a PPG probe, a pulse oximeter probe, an electroencephalogram probe, and a core body temperature probe.

26. An integrated base unit for use in a wearable monitoring platform substantially as described and shown.

27. A medical monitoring system substantially as described and shown.

28. A wearable base unit for medical monitoring substantially as described and shown.

29. A smart cable substantially as described and shown.

Images