WO2018067585A1 - Remote patient monitoring system (rpms) - Google Patents

Abstract

Real-time post-operative or post-admission patient monitoring apparatus configured for predicting the type and risk of one or more complications. A remote patient monitoring system (RPMS) performs multi-modality patient sensing, which can include, but is not limited to: EKG and arrhythmia, bio-impedance, skin conductance, SpO₂ and photoplethysmogram (PPG), patient sounds, blood pressure (BP), temperature, white blood cell count, accelerometer, range of motion, and other patient conditions. Based on this information and a database, RPMS compiles patient risk factors following a procedure / operation / admission, and communicates information to health care providers with instructions back to the patient toward increasing patient care and reducing complications.

Description

REMOTE PATIENT MONITORING SYSTEM (RPMS)

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, U.S. provisional patent application serial number 62/403,614 filed on October 3, 2016, incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable

INCORPORATION-BY-REFERENCE OF

COMPUTER PROGRAM APPENDIX

[0003] Not Applicable

NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION

[0004] A portion of the material in this patent document may be subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. § 1 .14.

BACKGROUND

[0005] 1 . Technical Field

[0006] The technology of this disclosure pertains generally to patient

monitoring, and more particularly to a remote patient monitoring system to facilitate communication between patients and their care providers. [0007] 2. Background Discussion

[0008] Patients undergoing operations are at increased risk for postoperative complications and readmission. Patients are also at risk of being readmitted subsequent to being admitted for medical conditions. While some measure of inpatient monitoring is performed, there are no systems in place for detecting complications arising between the time of their being discharged and their first post-operative clinic visit.

[0009] Accordingly, a need exists for a system and method which promotes care during these critical patient care time periods. The present disclosure fulfills that need, and provides additional benefits to both patients and care providers.

BRIEF SUMMARY

[0010] The disclosed Remote Patient Monitoring System (RPMS) is a

system, including a mobile application, that facilitates communications between patients and care providers (i.e., physicians, nurses, home health, skilled nursing facility, ancillary care, and so forth) in the peri-hospitalization and peri-procedural (episode of care) settings. The application utilizes survey questions, logs, camera, video, third-party sensors, and other methods for monitoring health (e.g., calorie intake, pedometer, HealthKit®, iWatch®, and any desired sensor, monitoring device, or combination thereof) in an integrated and purposeful manner to monitor patient conditions (e.g., status, complications) which may help promote patient health and behavior, allow earlier recognition of signs and symptoms, and provide alerts to providers to intervene on changes in clinical status.

Through these alerts, providers can more quickly respond to patients within their respective care pathways, thereby preventing readmission and/or emergency department (ED) visits. The platform can also reduce initial length of stay by allowing earlier discharge. The RPMS platform increases communications, thus allowing the patient 'voice' to be heard in an organized way while allowing their direct patient participation in postoperative / post-discharge care management. [0011] Further aspects of the technology described herein will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the technology without placing limitations thereon.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0012] The technology described herein will be more fully understood by reference to the following drawings which are for illustrative purposes only:

[0013] FIG. 1 is a schematic diagram of usage architecture for interaction with and processing information from a remote patient monitoring system (RPMS) according to an embodiment of the present disclosure.

[0014] FIG. 2 is a block diagram of vital sign sensing within a remote patient monitoring system (RPMS) according to an embodiment of the present disclosure.

[0015] FIG. 3 is a block diagram of motion artifact removal within EKG, PPG, or similar signals, as utilized according to an embodiment of the present disclosure.

[0016] FIG. 4 is a block diagram of a portion of FIG. 2, in which an

impedance measurement method is depicted according to an embodiment of the present disclosure.

[0017] FIG. 5 is a side view of a sensor configuration, showing example interaction and placement on the patient, according to an embodiment of the present disclosure.

[0018] FIG. 6A and FIG. 6B are depictions of a capacitive electrode and electrode integration, respectively, into the same substrate with other active components, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0019] 1 . Introduction

[0020] The disclosed remote patient monitoring system (RPMS) improves the collection and processing of patient reported outcomes (PROs). In at least one embodiment, the patient reported outcomes for a given service line (e.g., colorectal, cardiothoracic, etc.) or condition (e.g., pneumonia, congestive heart failure, or other conditions) can be selected by any desired method, including but not limited to being curated from peer-reviewed publications, best practice guidelines, existing health care databases, actual clinical practice and use, patient feedback, and data analysis to determine outcome, effectiveness, and value.

[0021] The manner in which the patient reported outcome data is organized and analyzed by the system allows providers to predict type and risk of complication during each subsequent peri-operative (peri-intervention, peri- admission, etc.) day and provides guidance on detection of complications while simultaneously influencing patient behavior toward reducing risk. For example, with the system knowing (containing information) that the patient has a smoking history the system then increases the number and / or depth of questions asked about 'pneumonia / atelectasis' symptoms, and patient instructions then include additional guidance on breathing exercises and increased use of incentive spirometer.

[0022] In another example, the system tailors questions given to a patient undergoing a colorectal operation to increase detection rate of

complications and problems most common to this subgroup. In at least one embodiment of the disclosure, these questions are further personalized using built-in logic and data analytics. By way of example and not limitation, in at least one embodiment, this further personalization includes patient's individual risk factors, current complications, and patient feedback. Clinical care operations by the disclosed system are applicable to any episode of care, and are particularly well-suited when following an operation, intervention or admission for a problem (e.g., a medical admission for pneumonia or congestive heart failure).

[0023] To expand the outreach of the remote patient monitoring system

(RPMS), the system integrates with other support services associated with or related to post-discharge patient care, for instance but not limited to, home health nurse agencies, skilled nursing facilities, and post-operative clinics. Historically, these areas have had limited connectivity and the disclosed system bridges that gap by providing relevant patient monitoring information in these respective care settings.

[0024] In addition to a focus on reducing readmissions, the RPMS system beneficially decreases length of stay duration for hospitalized patients in a peri-operative / peri-admission setting. For example, by giving providers a tool for more closely monitoring their post-operative patients, earlier detection of either clinical improvement or worsening conditions aid clinicians toward earlier interventions on those patients. This may allow patients to be discharged sooner, thus decreasing the duration of a hospital stay without increasing readmissions or emergency department (ED) visits. Having the RPMS in place improves the disparate gap in care between the hospital and the home (or skilled nursing facility (SNF)). Thus, physicians obtain additional confidence in discharging a patient earlier than would be otherwise planned, because of this additional remote monitoring which provides pertinent patient recovery information.

[0025] Embodiments of the disclosed system also facilitate obtaining patient information in the patient's own voice, upon which increasing attention is being paid in clinical situations. The RPMS provides a mechanism for patients to directly participate in their care by giving them a method of communicating their post-operative / post-discharge states in a well-defined way that fits into provider and patient workflows. Additionally, RPMS can improve patient safety as well as the overall patient experience, both of which are also utilized as performance measurements in at least one embodiment of the disclosure.

[0026] Using built-in logic and background analytics, the system alerts

providers to problems, such as through pre-programmed alerts which can be set to preferences. Patients are provided alerts for task reminders and / or for encouraging behavioral changes. The system improves patient- provider interaction by increasing efficiency, optimizing communication, education, and monitoring. The mobile application is comprised of an application designed to be downloaded onto a personal technology device (e.g., smart phone, tablet, computer or other electronic device having a processor and user interface) with a consumer-friendly user interface. The system also provides back-end data and analytic server reporting to support updates, optimizations, and rules-driven alerting to the providers and patients.

[0027] 1 .1 . General Features of RPMS.

[0028] FIG. 1 illustrates an embodiment 10 of usage architecture of RPMS.

In this figure the user-data interface comprising RPMS 18 is seen with additional system components in a utilization architecture according to at least one embodiment of the present disclosure. RPMS 18 is seen for interacting with user 12 and receiving vital sign information from a vital sign sensor device (or module) 14. Output from RPMS is directed to a back-end data and analytic server of the disclosure, referred to in the figure as signal search engine 20 which comprises processing and data archiving for the present disclosure. Output from signal search engine 20 comprises classification and analytics 26, and is directed to feedback processing 24 which determines metrics, alerts and guidance, and which initiates and generates outputs 28 (electronically) through the web, mobile, FAX, electronic health records, or other electronic communications mechanism to healthcare providers 16 (e.g., physicians, nurses, home health providers, skilled nursing facility (SNF) staff, clinics, and other health providers working with a specific patient) which interact with one another, user 12, electronic health records processing 22, and the signal search engine 20. Electronic health records processing 22 is configured for utilizing patient information, device registration, training information and maintaining records for the patients which are seen utilized by signal search engine 20.

[0029] It should be appreciated that each of the elements depicted as: vital sign sensor device 14, user-data interface 18, signal search engine 20, feedback 24, and electronic health records 22 are part of the present disclosure, although portions can be integrated with existing infrastructure, such as the electronic health records 22 sections shown in the figure. [0030] The overall system has a number of general features, which include but are not limited to the following. (1 ) The system utilizes a patient-facing application with a convenient, easy to understand, user interface. (2) Secure data transfers are performed through the use of encrypted data. (3) Any desired data formats can be supported, including but not limited to data formats for survey responses, images, video recordings, sensor data, and background analytics stored on secure servers with protected PHI, compliant with HIPAA standards. (4) Data output flexibility is provided by the system for integrating data output to respective clinical electronic health record (EHR) services, and other integrations with provider-based clinical workflows. (5) The system is configured to allow the clinical care

communication process to be tailored in any desired manner, including curating the desired process steps from peer-reviewed publications, existing health care databases, clinical practice, patient feedback, data analysis, and other sources without limitation.

[0031] By way of example and not limitation, embodiments of these

processes can include the following. (5)(a) Personalized patient reported surveys to evaluate outcomes specific to each service line or condition following operation, intervention, or admission. (5)(b) Patient risk factors for specific complications following operation, intervention, or admission. (5)(c) Existing and new risk predictors (e.g., LACE, NSQIP ACS risk calculator, and other risk predictors without limitation) for readmission or complication following each operation, intervention, and / or admission. (5)(d) Existing best practices care pathways for each operation, intervention, and / or admission. (5)(e) The manner in which the data is organized and analyzed (e.g., built-in logic and data analytics) in the disclosed system allows the providers to predict type and risk of complication during each subsequent peri-operative (peri-admission) day and provides guidance on detection of complication as well as influencing patient behavior to reduce risk. (5)(f) Each patient receives a personalized set of questions, tasks, alerts, or other activity / inputs, based on patient risk factors, type of operation, procedure, admission, existing complication, patient response, provider input, or other information made available to the system. Adaptive logic in the system aids in minimizing survey fatigue while improving early detection of

complications.

[0032] The system also includes general features including the following.

(6) The application is configured to provide the best outcome in the most effective way while providing value along the whole from the patient interfacing with RPMS to the healthcare providers overseeing each user and the various 3^rd parties, including those involved with health records, registration, training, reimbursement or other services. (7) The system is configured for compliance with reimbursement guidelines.

[0033] 1 .2. Specific Features of the System

[0034] Numerous specific features are also supported in one or more

embodiments of RPMS, including any desired combination of the following. (1 ) Utilizing patient reported surveys that are personalized and relevant to respective service lines or patient condition. (1 )(a) Utilizing surveys developed for each service line (e.g., colorectal surgery, orthopedic surgery, or any other desired service lines) or condition and for each type of patient operation, procedure, or admission. The surveys are tailored for specific patient risk factors to identify problems and address issues that may occur around the time of the operation, procedure, or episode of care. Patient reported outcome items, for example, can include diet, bowel function, physical activity, pain level, cognition, fatigue, sleep quality, wound condition, medication effects, emotional state, general well-being, and a wide range of known or new outcome items.

[0035] (1 )(b) A reiterative and adaptive survey process using built-in logic and data analytics is utilized based on best information, such as including peer-reviewed publications, best practice guidelines, existing health care database, actual clinical practice and use, patient feedback, and risk factors (LACE, NSQIP ACS risk calculator, EPIC dashboard with patient risk factors and information on current episode of care and existing complication at time of discharge, etc.), and other information. [0036] (1 )(c) The system is configured to readily expand to include any desired language, or languages (e.g., Spanish, Russian, French, or any desired language suited to parties in the communication) in both its text interfaces and speech recognition features.

[0037] (1 )(d) Design sensitivity is provided for technically-challenged users, for example older adults or those with social or motor impairments.

[0038] (2) Imaging communication is provided to promote remote

monitoring of wound complications, and may have any of the following. (2)(a) Camera input is supported and the system provides instructions on what to photograph, how to photograph it correctly, and feedback on successful capture. (2)(b) Video (e.g., WebEx) is supported and the system also provides instructions on how to perform video capture successfully. (2)(c) In addition, the system is configured to readily support any other desired method or path of communication.

[0039] (3) Patient event logging is provided, such as allowing any event to be logged, in particular those which require multiple inputs to achieve effective surveillance, which include but are not limited to pain level, fluid intake, urine or ostomy output, bowel movements, activity levels, sleep, and other event sources.

[0040] (4) The sensor interface in at least one embodiment is configured to be compatible with both new and existing technology. (4)(a) Integration with sensor devices, such as heart rate (e.g., iWatch), blood pressure, weight, blood sugar, accelerometer (e.g., Fitbit), abdominal sensors, and so forth. (4)(b) The system is configured for proper integration or compatibility with existing platforms (e.g., Apple HealthKit, ResearchKit, Google, EHR, or other platforms). (4)(c) Communication may be provided to and from the RPMS sensing device by any desired communication form, such as by utilizing WiFi, Bluetooth, other wireless protocols, manual entry, or any desired input source.

[0041] (5) Patient task notifications and / or reminders are configured to be initiated and sent as alerts to other personal devices of the patient (e.g., mobile phone or tablet via voice/text message, computer via email, notifications through a third party, internet and/or private network

communications, or other notification which is electronically initiated and/or generated). The tasks for which notification are provided are 'adaptive' based on user behavior and the goals of the monitoring toward improving user compliance.

[0042] (6) Physician, nurse, or provider alerts are initiated and generated based on patient responses. (6)(a) The alerts include a response level that is generated by provider preference and severity of symptoms. (6)(b) Alerts are based on provider preferences (e.g., alert to mobile phone through voice message, text message, pager, email, web connectivity, uploaded to an intermediary communication mechanism (e.g., EPIC CareConnect or In Basket), internet and / or private network communications, or other selected preferences).

[0043] (7) Home health (or skilled nursing facility) communication is

provided by the system. (7)(a) Providing increased efficiency of each patient visit in response to the system identifying alarming symptoms.

(7)(b) Improving communication between providers, patient, home health or skilled nursing facility nurse (e.g., regarding patient condition, changing orders, obtaining and viewing lab work, signing home health orders and other administrative paperwork, and the like). (7)(c) Options are provided to prescribe RPMS solely or to be utilized in conjunction with a visiting nurse. (7)(d) Any other communication (e.g., camera, video, messaging, audio, text, or other communication stream / recording) between

participants to enhance care.

[0044] (8) Communication with hospital / clinic or peri-operative facility is facilitated by the system. For example the system can initiate and generate an alert for urgent care for a patient having wound or drain issues, or has urinary symptoms, or is dehydrated and needs intravenous (IV) hydration, or requires blood work, or a need exists in regard to other issues or necessary interventions. One of ordinary skill in the art will appreciate that despite the number of such scenarios being nearly limitless, the system can initiate and generate communications toward facilitating and / or expediting communications between the critical care parties.

[0045] (9) Communication with other parties is facilitated by the system.

For example communication is facilitated (initiated and generated) with payors, such as insurance companies, laboratories, or other parties which are not strictly involved in the critical care (e.g., Quest for patient lab work, other ancillary services).

[0046] (10) Patient experience and education is facilitated by utilizing the disclosed system. (10)(a) This system allows the patient voice to be heard in a pre-scripted way by incorporating technology into the clinical care pathway. (10)(b) Patient education is increased. For example, patients develop an understanding of their symptoms, become more inclined to ambulate, and are more cognizant of their wounds. (10)(c) Links to patient resources are made increasingly available (e.g., educational websites, videos, articles, news feeds, holistic health feedback, nutrition, Gl and health, mental health, physical therapy exercises, incentive spirometer and other breathing exercises, yoga, and any other patient-centric resources). (10)(d) Information is provided by the system based on responses of patients. (10)(e) The system directs case focus onto patient or caregiver's feedback and / or voice inputs. (10)(f) In at least one embodiment of the system, interactive quizzes are provided and / or generated which aid both providers and patients in understanding and addressing deficits in the care process. (10)(g) In at least one embodiment, the system provides and / or links the patient to infotainment (e.g., health games and relaxation, psychosocial, entertainment, and other sources in this category). (10)(h) Long-term monitoring of behavioral changes and effects is facilitated by the use of the disclosed system (e.g., weight loss after bariatric surgery) or to provide survivorship following cancer resection (e.g., clinical practice guidelines and reminders to follow-up with lab work/CT imaging, and so forth). (10)(i) Evaluation of patient experience and satisfaction is made available through the use of the disclosed system.

[0047] (1 1 ) Interaction is provided in at least one system embodiment

between EPIC (CareConnect) or alternatively through cloud servers and mobile applications.

[0048] (12) Interfacing is performed by the system for direct communication between physician and home health / skilled nursing facility (e.g., any other party) or direct communication between provider and patient.

[0049] (13) The disclosed system is flexible and can be configured to

support any additional features for enhancing patient / provider experience, improving patient behavior, and detection of clinical changes in an efficient method toward reducing user efforts.

[0050] 1 .3. Dashboard Features of RPMS.

[0051] Following is a list of dashboard features which are supported by one or more embodiments of RPMS. (1 ) Management of patient data and device, including by example and not limitation, obtaining of a signal from the device to be sure that the communication connection has been established and is operational.

[0052] (2) Data visualization is provided by the RPMS device (e.g., patient- reported surveys, camera, sensor, graphs, plots, indicia, alerts, or other desired visual outputs) which allows immediate feedback regarding patient condition during an episode of care. Data visualization is provided by the system for patient task (e.g., oral intake of fluids, ostomy output, or any other patient task), for home health or skilled nursing facility (e.g., view of patient-reported condition over a period of time (e.g., last few days) along with pertinent patient information and instructions or concerns from providers), and for providers (e.g., dashboard of all patient-reported outcomes).

[0053] (3) An interface is provided by the dashboard for communication between providers (e.g., between physician and home health / skilled nursing facility, or other health care providers); and / or for a

communications interface between provider and patient.

[0054] (4) Sequenced storage of data is provided by the dashboard,

including but not limited to the following: Images, patient-reported data, sensor data in a way that is easy to read, and has summary statistics and trends. (5) In at least one embodiment, RPMS is configured for adapting and personalizing surveys based on patient condition, risk factors, type of operation / intervention, provider preferences, or other conditions and inputs. (6) Patient and provider task scheduling is facilitated using the dashboard of RPMS. (7) Patient condition alert settings can be set within RPMS for transmission to a healthcare provider, such as utilizing email, EHR, text or pager communications, or other mode of electronically generated communication typically selected based on provider preference.

[0055] 1 .4. Server Features of the RPMS.

[0056] The server of RPMS has a number of features included in one or more of its embodiments. (1 ) An interface is provided with enterprise EHR systems and other systems or database by the RPMS server. (2) User customization and modification options are provided by the RPMS server. (3) Application analytics are made available in response to storage and / or processing within the RPMS server.

[0057] 1 .5. Analytics Methods of RPMS.

[0058] The disclosed system is configured for performing a wide range of analytical processes in its various embodiments. (1 ) Analyses and cross- validation is performed by the system using external EHR and internal data.

(2) Prediction of complication or readmission risk using patient condition (e.g., patient factors, type of procedure, complication, etc.), is performed by the system, for instance using external risk calculators, internal database, EHR records, and other data sources and risk determination procedures.

(3) Prediction determinations are made by the system coupled with

'adaptive' logic when administering surveys and providing educational materials, when prompting patient to perform tasks which may help change behavior, or in other system actions.

[0059] (4) Analysis of data is performed by the system in at least one

embodiment toward providing information on hospital or program metrics, demonstrate effectiveness and demonstrating value. (5) Analysis of any other relevant outcomes of interest (e.g., patient experience and

satisfaction, and so forth) are performed according to one or more embodiments of the system. (6) Validation of patient-reported data and user experience are performed according to one or more embodiments of the system. (7) Analysis of any other pertinent data can be performed according to one or more embodiments of the system.

[0060] 1 .6. Sensors Utilized for RPMS.

[0061] Third-party sensors to complement RPMS are currently unavailable for numerous reasons. The sensor embodiment described below provides an integrated patch having the following features (separately or in combination thereof). (1 ) Ease of application of an integrated patch (as opposed to multiple sensors) which will result in improvement in patient use and compliance. (2) Integration of signals from the multiple sensor components to reduce false alerts which will also reduce provider alert fatigue. (3) A learning system with predictive analytics configured for establishing patient baseline levels so that out-of-range normals can be individualized. (4) The system is configured so that components of the sensor suite can be turned on and off (similar to survey questions) to personalize the system for the unique needs of the individual patient (e.g., a patient without cardiac risk factors would not necessarily require cardiac monitoring).

[0062] 1 .6.1 . Vital Sign Sensor.

[0063] FIG. 2 illustrates an example embodiment 30 of a vital sign sensor device. The sensor device is designed to perform multi-modality sensing, which are selected from the group of sensor inputs consisting of:

electrocardiogram (EKG) and arrhythmia, bio-impedance, skin

conductance, peripheral capillary oxygen saturation (Sp0₂) and

photoplethysmogram (PPG), bowel sounds, breath sounds, blood pressure, temperature, white blood cell count, accelerometer, and range of motion, either separately or in combination.

[0064] Electrodes 32 are seen comprising separate electrodes 34a, 34b, 34c, by way of example and not limitation, which are connected to the EKG measurement circuits 36 composed of amplifiers and filters. Electrodes 32 are also shared by the impedance measurement unit 38 to reduce device form factor. Impedance and skin conductance are acquired by delivering a current stimulus and measuring the evoked electrode overpotential. Output 37 from EKG measurement circuit 36, and impedance measurement 39 from impedance measurement circuit 38, are directed to control processor 40 (e.g., microcontroller, DSP, FPGA, other control circuits, or combinations thereof).

[0065] Photodiodes and LEDs 42, comprising at least 44a, 44b respectively, in the device are configured for emitting light and capturing its reflection as processed by SpO2 and photoplethysmogram circuit 46 which determines peripheral capillary oxygen saturation (SpO2) and a PPG measurement, which is directed to control processor 40.

[0066] Patient sounds (e.g., bowel, breath, voiced, heart rate sounds or other physiological sounds) are then captured by the use of at least one microphone 48 (or other sound / vibration transducer), processed by a sound processing circuit 50 before being received by control processor 40.

[0067] Each sensing modality can be activated independently or

simultaneously by the system by its control processor (i.e., microcontroller, digital-signal-processor (DSP), field-programmable-gate-array (FPGA), application-specific integrated circuit (ASIC), or other forms of control circuitry without limitation).

[0068] Communications to and from control processor 40 are exemplified with at least one wireless communications module 52 and antenna 54, such as comprising WiFi, Bluetooth, or other communications standard which is most compatible within the architecture within which the RPMS device is operating. In at least one embodiment, environmental information is received from at least one circuit 56 and associated antenna 58 by control processor 40. By way of example and not limitation this environmental information is depicted as a global positioning sensor (GPS) 56 and its antenna 58 for obtaining patient location and motion information. It will be appreciated that other environmental information may be obtained without limitation, such as body range of motion, temperature, humidity, wind, environmental audio, still picture, video, and / or other inputs depending on the needs of the patient and the specific application to which the RPMS is being utilized.

[0069] Therefore, in at least one embodiment, the recorded signals from control processor 40 are transmitted through wireless communications 52 to both the RPMS system and the user's mobile device or cloud storage for further signal processing. It is important to point out that although the proposed sensing modalities are similar to other vital sign sensors or biosensors, novel hardware configurations and schemes are disclosed toward achieving improved performance and facilitating device operation and patient usage.

[0070] Important elements of the sensor design include, but are not limited to the following, (a) Motion Artifact Removal: The removal of motion artifacts is one of the most challenging problems in EKG / ECK or PPG recording as these artifacts contaminate the recorded signals of interest. One common approach to artifact removal is through adaptive noise filtering using a noise reference signal derived from accelerometers. It is assumed that the motion of the device / sensor is related to the artifact. Nonetheless, this leads to extra hardware cost, and more critically, there is not significant correlation between PPG and the acceleration data from the accelerometer. Motion artifacts more particularly arise from the

deformation of the skin. For EKG, as the skin deforms, its unit capacitance (Cunit) varies while the overall charge residing on the skin (Q) remains the same, leading to the skin potential change (AV = Q / C_unit)- Moreover, skin deformation also affects the intensity of the reflected light during PPG measurement. The extracted impedance is thus related to the PPG motion artifact. By extracting the electrode tissue impedance, a reference signal can therefore be derived to cancel or alleviate the influence of motion artifacts.

[0071 ] FIG. 3 illustrates an example embodiment 70 of motion artifact

removal. A signal 72 for motion induced impedance is seen received by an adaptive filter 74 (i.e., least mean square, Kalman, or Wiener filter, and other adaptive filters) in which its computation can be made in the microcontroller / FPGA / DSP of the sensor device. EKG (ECK) or PPG signals containing motion artifacts 76 are received at the positive input of a summing junction 78. Output from filter 74 is received at the negative input 80 of summing junction 78, with the summing junction outputting a signal 82 which is also seen coupled back to filter 74 so that the filter can adapt to the output.

[0072] Filter 74 adaptively adjusts the magnitude of the impedance signal to match that of the motion artifact captured in EKG (ECK) or PPG recording. Subsequently, the adjusted impedance signal is used as the approximated motion artifact and is subtracted from the artifact contaminated EKG / PPG signal to produce an artifact-free signal.

[0073] FIG. 4 illustrates an example embodiment 90 showing the unique approach of the disclosure for acquiring impedance information. In the figure is seen the same group of electrodes 32, shown with separate electrodes 34a, 34b, 34c, as well as EKG measurement 36 with output 37, impedance measurement 38 with output 39. For the sake of illustration the control circuitry is not shown. Example signals 93 are shown in the figure for PPG and EKG.

[0074] As shown in the figure, a circuit 100 having a current pulse generator 104 and high pass filter 102 are seen coupled to electrode inputs (e.g., shown for electrodes 34a, 34b). The current pulse generator 104 is utilized to deliver a current stimulus to these EKG electrode inputs to the EKG measurement block 36, as exemplified by the injected high frequency current pulses 105. Unlike other approaches that use an excitation signal at a fixed frequency for impedance measurement, a high frequency square current pulse (e.g., greater than 1 kHz) is utilized in the disclosed system. The pulse repetition frequency is set greater than or equal to 10 Hz to sample the changing impedance. The advantage of the short square stimulation pulse is that it facilitates the derivation of the tissue resistance and electrode-interface capacitance, and is not limited to deriving the impedance at a fixed frequency. An additional advantage lies in that it simplifies the hardware design and reduces system power consumption (i.e., main components are merely a high pass filter (HPF) and analog-to- digital converter (ADC) as a front end to the processing circuitry).

[0075] In order to estimate the impedance, the electrode-tissue interface is modeled as a Randel's cell electrode model 92 shown with parallel resistance R_ct and capacitor C_di, which are in series with resistor R_s. When a high frequency square current is injected into it, the resulting electrode overpotential V_c 98 will only comprise: (a) V_e: the voltage drop across the tissue resistance (R_s) and (2) V_c: the following voltage crosses the double layer capacitance (C_di) due to capacitive current charging. As the stimulation intensity is known, the value of R_s and C_di can be determined by measuring the electrode overpotential. A high-pass filter is used herein to remove low frequency signal, such EKG and PPG. The approach allows the sharing of the electrodes with EKG measurement circuits as the signal frequency used for impedance measurement is substantially higher, for instance greater than 1 kHz, than that of the EKG and PPG signals which for example range up-to approximately tens of Hz. Moreover, the impedance change (i.e., R_s and C_di variation) is also related to the deformation of the skin, the cause of motion artifact. Motion artifact can thus be extracted by first sampling the peak voltage changes of the V_c 98 and then by low-pass filtering to derive its voltage waveform V_e 96. V_e is low-pass filtered and then fed to a filter as seen in FIG. 3 in order to derive an artifact-free recording signal. In the figure an EKG measurement output 94 is shown as well as an LPF filtered V_e 96.

[0076] Measurements of skin conductance (e.g., electrodermal response) have been utilized to infer sympathetic activity. It is thought that skin conductance varies due to sweating in the skin which is governed by the sympathetic nerve system. By using the above impedance measurement technique, the system can perform continuous measurements of skin conductance by acquiring values for R_s and C_d|.

[0077] In blood pressure (BP) measurements, pulse transition time (PTT) is utilized according to embodiments of the present disclosure as an noninvasive solution to measuring blood pressure. PTT is defined as the time between two separate pulse waves propagating on the same cardiac cycle from two separate arterial sites. PTT is acquired by simultaneously measuring EKG and PPG from different sites. This approach imposes the challenge of accurate synchronization of these two measurements. The existing BP measurement based on PTT is also inconvenient, as it requires wires connecting the sensor measuring PPG and the other sensor measuring EKG. The measuring circuits must share the same system clock in order to accurately estimate PTT for BP estimation. Recently, a BioWatch was reported to perform BP measurement based on PTT by integrating both sensors in the same device, but such capability is limited since this form of EKG measurement prevents the user from performing normal activities as both hands of the user are demanded to keep in contact with the BioWatch simultaneously and are further susceptible to motion artifacts.

[0078] Thus, in order to simplify obtaining vital measurements while

resolving synchronization issues, at least one embodiment of the present disclosure utilizes a patch sensor which overcomes the synchronization issue and provides convenient BP measurements.

[0079] FIG. 5 illustrates an example embodiment 1 10 of a sensor

configuration for use with the present disclosure, and configured for being interacted with by the hand 1 12 of a user. In the example shown, the sensor device 1 16 is configured for attachment to the chest of user 1 14, although it could be configured to attach at other locations of the body that would not impede activities of the user. By way of example and not limitation, sensors, processing and telemetry circuitry are retained in a first circuit module 1 18, which is coupled through connectors 124a, 124b, and more preferably additional connectors not seen in the figure, with an electrode base 126 configured for retention on the skin of a user.

Electrodes (120a, 120b, 128, 132a, 132b) for EKG measurement and LED/Photodiodes (122a, 122b, 130a, 130b) face outwardly on opposing sides of the device. In at least one embodiment, first circuit module 1 18 can be disconnected from electrode base 126, without the need of breaking the adhesive attachment between electrode base 126 and the skin of the patient, toward facilitating servicing of module 1 18, and allowing the patient to bath or perform other daily activities with the sensor out of the way. In at least one embodiment, the system is configured to work with an option of a patch that can be worn in the shower, while sleeping, exercising and so forth.

[0080] During EKG measurements, three electrodes on the bottom (128,

132a, 132b) are activated to acquire an EKG signal, with its motion artifacts being suppressed, such as described in the previous section. For PPG measurements, LEDs (122a, 122b, 130a, 130b) on both sides of the device are enabled to acquire PPG signals from either the fingertip or the chest. Critically, during BP measurement requiring synchronized EKG and PPG, the LED/photodiodes on the bottom side are activated to record PPG while at the same time, the EKG is measured from the fingertips of a user's hand 1 12 using two electrodes on top of the sensor device. PTT from the heart to the fingertip can then be acquired. Both measurements are also synchronized due to the use of the same device and the procedure is convenient because no additional wire connecting different sensors is required.

[0081] FIG. 6A and FIG. 6B illustrate example embodiments 150a, 150b of electrodes for use in the present disclosure. In the embodiment 150a of FIG. 6A the electrode on top of the device is seen as a capacitive electrode, such as comprising a flexible substrate (i.e., polyimide, silicone, parelyene, or other flexible base material) which can support a metal electrode 154 insulated 152 from the patient skin surface, or by way of further example a simple low-cost printed circuit board may be utilized. The benefit of using a capacitive electrode are as follows, (a) The capacitive electrode does not require direct contact between patient skin surface and the device, thus allowing measurements to be made even when cloth is on top of the electrodes, (b) Using the capacitive electrode generates a quality signal which is insensitive to skin condition.

[0082] FIG. 6B illustrates an example embodiment 150b of integrating

active circuitry with the electrodes. In the figure, elements 158a and 158b are examples of active circuits / components (e.g. batteries, amplifiers, processors, and wireless transceiver, or other circuitry) that acquire and process the recorded physiological signals. In at least one embodiment, the active components can be placed on either side of substrate 150b, depending on the need of the application. Trace 156 is an example of conductive (e.g., metal) traces used to form the necessary electrical connection between each active component as well as the conductive trace that forms an inductive coil inside the sensor substrate for wireless charging the sensor patch. Section 154 in FIG. 6B depicts the metal trace / plate that can be translated into a capacitive electrode by adding an insulated layer / coat, or simply being insulated in response to use with existing electrical insulation, such as by the patient's clothes. On the other hand, as an alternative, conductive section 154 in FIG. 6B can also be connected to other types of sensors, providing the flexibility that different types of sensors can be incorporated into the sensor patch (e.g., temperature sensor, PH sensor, and accelerometer).

[0083] Towards shrinking sensor device size, at least one embodiment of the present disclosure integrates the capacitive electrode with the active circuits on the same flexible substrate of PCB board. The electrode is covered by an insulation layer and connected to active circuits for signal recording.

[0084] Table 1 presents an embodiment of program code utilized for

implementing an embodiment of the described technology. It should be appreciated that the program code is provided by way of example and not limitation, as the general technique is applicable to variations of this code example.

[0085] 2. Commercial Applications and Competitive Advantages.

[0086] Traditional methods for discharge intervention, including nurse- delivered telephone support services after an operation or admission for medical condition, are not adequate to meet patient needs. Patients have difficulty remembering their discharge instructions and identifying problems with their wound care or pain medication. These challenges can lead to an undue number of readmissions, such as the fact that one out of every eight Medicare patients requires readmission within 30 days.

[0087] At present, annual Medicare (medical and surgical) readmission cost is $26 billion dollars. Currently, 30% of health care dollars are spent in the six months subsequent to an operation, and these costs are projected to rise. Adverse events after surgery which require emergency department visits or readmissions have increased over the last decades and may be increasingly used as a performance metric for hospitals and for determining Medicare reimbursement.

[0088] The majority of readmissions after operations occur within the first two weeks following discharge. Post-operative and post-intervention complications are well-defined. The disclosed remote patient monitoring system (RPMS) is configured to fill these gaps in post-operative patient care. Remote monitoring can be easily incorporated into existing clinical care pathways to capture essential peri-operative information in order to detect complications sooner, thereby allowing opportunities for intervention. For example, patients undergoing colorectal operations may experience wound infection or dehydration. Monitoring of the wound and of fluid intake, urine output, and ostomy output would allow for earlier detection, thereby providing an opportunity for earlier clinical care guidance to be given to patients, potentially reducing readmissions or ED visits and cost.

[0089] The RPMS platform application targets individual patient risk factors following each procedure, operation, or admission based on the best information available, such as from clinical information curated for each service line from peer-reviewed publications, best practice guidelines, existing health care database, actual clinical practice and use, patient feedback, and data analysis to determine outcome, effectiveness, and value. The manner in which the data is organized and analyzed by the disclosed system allows providers to predict type and risk of complication during each subsequent peri-operative / peri-admission day and provide guidance on detection of complication while also influencing patient behavior toward reducing risk. [0090] In addition to a focus on reducing readmissions, the RPMS platform may also decrease length of stay duration for hospitalized patients in the peri-operative / peri-admission setting. For example, by giving providers a tool to more closely monitor their post-operative patients, earlier detection of either clinical improvement or worsening conditions will help guide clinicians to earlier interventions on those patients. The early detection ability can allow patients to be discharged sooner and decrease hospital stays without increasing readmissions or ED visits. Having RPMS in place will accordingly improve the disparate gap in care between hospital and home (or SNF). Thus, physicians will gain confidence in discharging a patient earlier than planned because of this additional remote monitoring which provides pertinent information related to the patient's recovery.

[0091] To expand the outreach of RPMS, at least one embodiment of

RPMS integrates with other support services which are vital to patient care post-discharge including home health nurse agencies, skilled nursing facilities, and post-operative clinics. Historically, these support service areas have had limited connectivity. RPMS helps bridge this support services communication gap by providing relevant patient monitoring information in respective care settings.

[0092] There has also been increasing focus on the importance of hearing the patient's voice. RPMS provides a mechanism for patients to directly participate in their care by giving them a method of communicating their post-operative / post-discharge states in a well-defined way that fits into the provider and patient workflow. Additionally, RPMS improves patient safety and patient experience both of which are also being used as performance measurements.

[0093] In summary, RPMS capitalizes on the opportunity to improve patient care by reducing readmissions to the hospital as well as reducing hospital length of stay. This is achieved by tailoring the application and platform to focus on optimizing the provider-patient interaction in the peri-operative / peri-admission period using patient self-reported data, image data, log data, and wireless sensor data. The system has the capability to support the clinical care pathway for respective service lines to capture the relevant data elements in order to provide the right guidance to improve patient care. The clinical algorithm described can be applied to patients

undergoing operations, interventions or admitted for a medical condition (e.g., pneumonia or congestive heart failure) to provide similar benefits in care. The system and its analytics are clinically validated through analysis of patient information, patient-reported data, user experience, and evaluation of outcome data to demonstrate effectiveness and value.

[0094] 3.0. Five Components of RPMS.

[0095] Following are described five important areas regarding RPMS.

[0096] (1 ) In at least one embodiment, a set of questions is pre-determined based on features including type of operation, risk factors of the patient, and clinical care pathways of the specialty service. Selection of patient survey questions is described below.

[0097] In at least one embodiment, patient surveys are selected from a comprehensive repository of questions (e.g., surveys, serial logs, camera, video, sensors, and other inputs without limitation), and the survey set can be further personalized in the system for a patient based on any one of the following or combinations thereof: (a) type of operation, procedure, admission determines the type of patient survey; (b) personal risk factors (e.g., age, co-morbidities, lives alone, malnutrition, smoker, or other data or condition) are factored into the patient survey; (c) complications that occurred during hospitalization (e.g., urinary tract infection), are also registered in the survey; (d) risk factors from peer-reviewed publications that predict higher complication or readmission rates, are taken into account; (e) risk factors from local (hospital) or national patient database that predict higher complication or readmission rates after a particular operation, procedure, admission are accounted for; (f) time period after surgery, intervention, admission (e.g., liberalize diet two weeks post- discharge; progressive increase in ambulatory activity) is accounted for in the survey; (g) behavioral changes that are required (e.g., incentive spirometry use, ambulation, or other desired behavior modifications), are noted in the survey; (h) questions are categorized and grouped purposefully into sets within the survey to provide a context for understanding the questions; (i) questions in certain instances are customized based on the clinical care pathway of each provider or group practice, thereby aligning the questions with the clinical care pathway; (j) the repository of questions for each patient will include a personalized complement of survey

questions, instructions for log measurements (e.g., weight, blood pressure, or other patient information), photos using the camera, video calls, and selected sensors; (k) sensor data or other third party applications with health monitoring including information from patient android / iOS mobile devices (e.g., Fitbit ambulation, text message usage activity, sleep pattern, HealthKit, nutritional intake, and other data that the patient selects for use from their mobile device) to augment health monitoring (e.g., detection of depression) and promote behavioral change (e.g., alert to increase activity); (I) enhanced communications for patients who have home health nurses or are at a skilled nursing facility to share clinical information with these partners, to allow other relevant caregiver / providers to interact with the patient in a more meaningful way; (m) subsequent questions and sets of questions are selected by the system based on a single answer or several answers and in turn can trigger an additional single question or set of questions to further understand the condition of the patient, with areas of interest such as cognition and mental condition, physical condition (e.g., pain, diet, digestion / bowel function, medication usage, sleep quality, fatigue, activity), and data regarding patient condition or experience.

Other conditions specific to patients undergoing a specific operation or with admission for a particular disease state that would also be valuable for patient care can be included. Conditions that affect the patient in the hospital or individual risk factors would also generate in the patient's question list a pre-determined set of questions. Logs of interest include fluid intake, ostomy output, blood pressure, ambulation activity,

temperature, heart rate, pain level, and others datum as selected for the specific application and instance. Questions range from common general questions to highly specific.

[0099] (2) The patient provides input into the RPMS application in response to specific personalized prompts and instructions (e.g., survey questions, instructions to upload images of wounds, sensor data, etc.).

[00100] The disclosed system not only generates questions for the patient regarding their symptoms, but includes objective surgery-specific / admission-specific data (e.g., ostomy output, wounds, HR, or other information important for the admissions process).

[00101] (3) The data is transferred to a computer that organizes and

analyzes the data using analytics and the "clinical care algorithm" to predict the type and risk of complications.

[00102] Intelligent reporting of values which appear concerning are

communicated back to the provider by the system based on clinical literature, patient demographics, and preferences of the clinical team (clinical care algorithm). With larger numbers of patients, an iterative assessment of risk factors and complications will provide additional predictive capability.

[00103] (4) Data analysis in the system includes any one or all of the

following data analysis processes, (a) Dashboard retains RPMS data as well as data abstracted from the electronic health records (EHR). Providers are able to document data observations and patient interactions. In at least one embodiment, this data is made available for review by all parties, while the system can support one or more modes in which data is restricted to, or from, designated parties. In at least one embodiment, this documentation and RPMS data is integrated into the EHR to provide for basic charting, (b) RPMS offers analysis of outcomes (e.g., metrics or outcomes such as readmissions, length of stay, weight loss, patient experience, behavioral change, depression, or any other outcome analysis), (c) RPMS is a learning system across levels ranging from learning more about each type of post-operative care, to learning more about each patient. With iterative evaluation of daily data from a patient and then from multiple patients undergoing the same type of operation with the same risk factors, the system learns method of predicting complications, promoting behavioral changes, detecting health problems such as mental health problems, and many other areas.

[00104] (d) The analytic system is configured for branching decision tree questions. In addition, the system provides a method for analyzing answers based on clinical course and knowledge, (e) Patient data can be analyzed using statistical methods such as correlation / regression and other methods so that evaluation of answers to certain questions will enhance predictive capability (e.g., patients undergoing a particular type of operation who answer select questions a certain way may have an early complication), (f) One goal is to decrease survey fatigue by asking the least number of questions to obtain the best answer. For example, patients who answer one way a few times may not need to be asked this question again in the future. Or alternatively, one answer will lead the patient to a series of questions which will more quickly indicate that the patient has depression or an early complication, (g) Ultimately, accumulation of a large number of patients will allow for use of big data analytics.

[00105] (4) Alerts are highlighted and sent back to responsible provider in real-time. Patients are given real-time alerts, instructions, and educational materials.

[00106] (5) Doctors can intervene if risk is detected or patient has concerns, (a) Alerts will be generated for providers and patients based on predetermined values (based on clinical literature, patient demographics, and preferences of the clinical team, or other inputs as desired), (b) System output is not just tailored education, but real-time feedback to the provider (tiered alert mechanism based on urgency) and patient instructions regarding clinical care, (c) The timing of the surveys and logs and additional alerts provided engage the patient to enhance behavioral modification or adherence (e.g., medication adherence), (d) Each clinical provider group will have the opportunity to make changes (e.g., add, select, delete or amend and so forth) from the question bank based on the preference of the physician and make adjustments to alert settings. [00107] 4.0. Additional Purposes of RPMS.

[00108] Additional purposes of RPMS includes any one or more of the

following: (1 ) to identify complications sooner so that risk may be mitigated; (2) to reduce readmission or ED visits; (3) to promote behavioral change so that the patient becomes an active rather than passive participant; (4) to engage caregivers; (5) to reduce patient and caregiver anxiety around the time of operation, procedure, admission; (6) to improve pre-operative, pre- procedure preparation, education and to give patients an improved understanding of the process since the information is repeated; (7) to improve monitoring and enhance communication between different types of providers (physicians, skilled nursing facility, visiting nurses) and patients; (8) to decrease length of stay by decreasing the steep drop-off in

monitoring between inpatient and post-discharge care; (9) to improve provider-patient interaction by making the interaction more efficient, targeted focused questions may be asked rather than a set of exploratory questions; (10) to improve clinic efficiency by allowing for changes to postoperative appointments to accommodate urgency, and if the patient is doing well, then selecting for example the use of telemedicine postoperative visits; (1 1 ) to incorporate information from a variety of tools (survey questions, serial log, camera, video, sensors, and other tools as desired) to provide gather targeted and personalized information about patients to providers (With daily remote monitoring and iterative participation in answering the personalized question set, which is designed to detect an individual patient's risk of complications, each patient becomes more capable of identifying concerning issues); (12) to gather information (e.g., ambulation, text activity, sleep pattern, and / or other patient information) from patient mobile devices (e.g., android, iOS, or other smart device platforms) to augment health monitoring (e.g., detection of depression, or other health status or conditions) and promote behavioral change (e.g., alert to increase activity, or other alerts / directions); (13) to provide an integrated ecosystem that connects the patient, caregiver and providers during an episode of care; (14) to improve health care delivery by focusing on preventive rather than reactive care. Care is based on patient information which is sent through alerts to providers in real-time. This results in more rapid feedback to patients who are also provided with message alerts, instructions, educational materials, other forms of information, or combinations thereof; (15) the RPMS may be continued indefinitely for years or decades following an episode of care in order to assess long-term outcome or evaluate chronic disease states (e.g., weight loss, cardiac disease, depression after surgery).

[00109] Embodiments of the present technology may be described herein with reference to flowchart illustrations of methods and systems according to embodiments of the technology, and / or procedures, algorithms, steps, operations, formulae, or other computational depictions, which may also be implemented as computer program products. In this regard, each block or step of a flowchart, and combinations of blocks (and / or steps) in a flowchart, as well as any procedure, algorithm, step, operation, formula, or computational depiction can be implemented by various means, such as hardware, firmware, and/or software including one or more computer program instructions embodied in computer-readable program code. As will be appreciated, any such computer program instructions may be executed by one or more computer processors, including without limitation a general purpose computer or special purpose computer, or other programmable processing apparatus to produce a machine, such that the computer program instructions which execute on the computer processor(s) or other programmable processing apparatus create means for

implementing the function(s) specified.

[00110] Accordingly, blocks of the flowcharts, and procedures, algorithms, steps, operations, formulae, or computational depictions described herein support combinations of means for performing the specified function(s), combinations of steps for performing the specified function(s), and computer program instructions, such as embodied in computer-readable program code logic means, for performing the specified function(s). It will also be understood that each block of the flowchart illustrations, as well as any procedures, algorithms, steps, operations, formulae, or computational depictions and combinations thereof described herein, can be implemented by special purpose hardware-based computer systems which perform the specified function(s) or step(s), or combinations of special purpose hardware and computer-readable program code.

] Furthermore, these computer program instructions, such as embodied in computer-readable program code, may also be stored in one or more computer-readable memory or memory devices that can direct a computer processor or other programmable processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory or memory devices produce an article of manufacture including instruction means which implement the function specified in the block(s) of the flowchart(s). The computer program instructions may also be executed by a computer processor or other programmable processing apparatus to cause a series of operational steps to be performed on the computer processor or other programmable processing apparatus to produce a computer-implemented process such that the instructions which execute on the computer processor or other programmable processing apparatus provide steps for implementing the functions specified in the block(s) of the flowchart(s), procedure (s) algorithm(s), step(s), operation(s), formula(e), or computational

depiction(s).

] It will further be appreciated that the terms "programming" or "program executable" as used herein refer to one or more instructions that can be executed by one or more computer processors to perform one or more functions as described herein. The instructions can be embodied in software, in firmware, or in a combination of software and firmware. The instructions can be stored local to the device in non-transitory media, or can be stored remotely such as on a server, or all or a portion of the instructions can be stored locally and remotely. Instructions stored remotely can be downloaded (pushed) to the device by user initiation, or automatically based on one or more factors. ] It will further be appreciated that as used herein, that the terms processor, hardware processor, computer processor, central processing unit (CPU), and computer are used synonymously to denote a device capable of executing the instructions and communicating with input/output interfaces and/or peripheral devices, and that the terms processor, hardware processor, computer processor, CPU, and computer are intended to encompass single or multiple devices, single core and multicore devices, and variations thereof.

] From the description herein, it will be appreciated that the present disclosure encompasses multiple embodiments which include, but are not limited to, the following:

] 1 . An apparatus for real-time post-operative or post-admission monitoring of a patient, the apparatus comprising: (a) an electronic vital sign sensor module configured for attachment to a patient, said electronic vital sign sensor module comprising an electrocardiogram (EKG) sensor and measurement circuit configured for collecting EKG measurements, and a plurality of sensors configured to perform multi-modality sensing with sensors for collecting bio-impedance, skin conductance, peripheral capillary oxygen saturation (Sp0₂) and photoplethysmogram (PPG), blood pressure (BP), temperature, and having at least one microphone for sound collection; (b) a processor configured for receiving and processing sensor information from said vital sign sensor; (c) a non-transitory processor-readable memory storing instructions executable by said processor, wherein said instructions, when executed by said processor, performs steps comprising: (c)(i) compiling one or more individual patient risk factors following a procedure, an operation, or an admission based on clinical information, and

determining clinical care processing; (c)(ii) predicting a type and risk of one or more peri-operative or peri-admission complications based on measured patient vital sign information in relation to patient-reported information, and patient history using said clinical care processing; (c)(iii) electronically initiating and communicating said predicted type and risk of said one or more peri-operative or peri-admission complications to a health care provider; and (c)(iv) electronically initiating and communicating instructions and information back to the patient to reduce said predicted type and risk of said one or more peri-operative or peri-admission complications.

] 2. A method for predicting type and risk of peri-operative or peri- admission complications, the method comprising: (a) attaching a processor- enabled vital sign sensor device to a patient for collecting patient sensor information and for recording and transferring patient-reported information; (b) transferring said patient sensor information and said patient-reported information from said processor-enabled vital sign sensor device to a computer processor; (c) compiling individual patient risk factors on a computer processor and associated memory following each procedure, operation, or admission based on clinical information to construct a clinical care algorithm; (d) predicting a type and a risk of one or more peri-operative or peri-admission complications on the computer processor based on collected patient sensor information, patient-reported information in relation to patient history using said clinical care algorithm; (e) communicating from the computer processor said predicted type and risk of said one or more peri-operative or peri-admission complications to a health care provider; and (f) communicating instructions and information from said computer processor back to the patient to reduce said predicted type and risk of said one or more peri-operative or peri-admission complications; (g) wherein said method is performed by executing instructions, on said computer processor, said instructions residing in a non-transitory memory readable by said computer hardware processor.

] 3. An apparatus for real-time post-operative or post-admission monitoring of a patient, the apparatus comprising: (a) a vital sign sensor module configured for attachment to a patient, said electronic vital sign sensor module configured to perform multi-modality sensing, including electrocardiogram (EKG) and arrhythmia, bio-impedance, skin

conductance, peripheral capillary oxygen saturation (Sp0₂) and

photoplethysmogram (PPG), blood pressure (BP), temperature, white blood cell count, accelerometer, range of motion, with at least one microphone for patient sound collection; (b) a processor configured for receiving and processing patient sensor information from said vital sign sensor into measured patient vital sign information; (c) a non-transitory processor- readable memory storing instructions executable by said processor, wherein said instructions, when executed by said processor, performs steps comprising: (c)(i) compiling one or more individual patient risk factors following a procedure, an operation, or an admission based on clinical information, and determining clinical care processing; (c)(ii) predicting a type and a risk of one or more peri-operative or peri-admission

complications based on measured patient vital sign information in relation to patient-reported information, and patient history using said clinical care processing; (c)(iii) electronically initiating and communicating said predicted type and risk of said one or more peri-operative or peri-admission

complications to a health care provider; and (c)(iv) electronically initiating and communicating instructions and information back to the patient to reduce said predicted type and risk of said one or more peri-operative or peri-admission complications.

[00118] 4. The apparatus or method of any preceding embodiment, wherein said sound collection is configured for capturing sounds from a group of biological sounds consisting of voiced sounds, bowel sounds, breath sounds, and heart sounds.

[00119] 5. The apparatus or method of any preceding embodiment, wherein said electronic vital sign sensor module is further configured for collecting vital signs from the group of vital signs consisting of white blood cell count, acceleration, and range of body motion.

[00120] 6. The apparatus or method of any preceding embodiment, wherein said electrocardiogram (EKG) sensor and measurement circuit further comprises EKG amplifiers and filters.

[00121] 7. The apparatus or method of any preceding embodiment, wherein said electrocardiogram (EKG) sensor and measurement circuit is

configured for extracting electrode tissue impedance and a reference signal utilized in removing motion artifacts when generating a resultant EKG signal.

[00122] 8. The apparatus or method of any preceding embodiment, wherein impedance and skin conductance are acquired by delivering a current stimulus and measuring evoked electrode overpotential.

[00123] 9. The apparatus or method of any preceding embodiment, wherein said electronic vital sign sensor module is configured with photodiodes and LEDs for emitting light and capturing light reflection from the LEDs in measuring peripheral capillary oxygen saturation (Sp0₂) and

photoplethysmogram (PPG).

[00124] 10. The apparatus or method of any preceding embodiment,

wherein said electronic vital sign sensor module is configured for delivering a current stimulus and measuring evoked electrode overpotential in determining said bio-impedance and said skin conductance.

[00125] 1 1 . The apparatus or method of any preceding embodiment,

wherein different sensors, representing different sensing modalities, within said electronic vital sign sensor module can be activated independently or simultaneously through control from the processor.

[00126] 12. The apparatus or method of any preceding embodiment,

wherein said predicted type and risk of said one or more peri-operative or peri-admission complications is electronically communicated to a health care provider based on provider communication preferences selected from the group of communication types consisting of voice message, text message, pager notification, electronic mail, internet and/or private network communications, uploaded to an intermediary communication mechanism, or combination.

[00127] 13. The apparatus or method of any preceding embodiment,

wherein communicating instructions and information back to the patient is performed using an electronic communications medium selected from the group of electronic communications medium consisting of voice message, text message, electronic mail, internet and/or private network

communications, electronic notifications through a third party, or other notification which is electronically initiated and / or generated. [00128] As used herein, the singular terms "a," "an," and "the" may include plural referents unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more."

[00129] As used herein, the term "set" refers to a collection of one or more objects. Thus, for example, a set of objects can include a single object or multiple objects.

[00130] As used herein, the terms "substantially" and "about" are used to describe and account for small variations. When used in conjunction with an event or circumstance, the terms can refer to instances in which the event or circumstance occurs precisely as well as instances in which the event or circumstance occurs to a close approximation. When used in conjunction with a numerical value, the terms can refer to a range of variation of less than or equal to ± 10% of that numerical value, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1 %, less than or equal to ±0.5%, less than or equal to ±0.1 %, or less than or equal to ±0.05%. For example, "substantially" aligned can refer to a range of angular variation of less than or equal to ±10°, such as less than or equal to ±5°, less than or equal to ±4°, less than or equal to ±3°, less than or equal to ±2°, less than or equal to ±1 °, less than or equal to ±0.5°, less than or equal to ±0.1 °, or less than or equal to ±0.05°.

[00131] Additionally, amounts, ratios, and other numerical values may

sometimes be presented herein in a range format. It is to be understood that such range format is used for convenience and brevity and should be understood flexibly to include numerical values explicitly specified as limits of a range, but also to include all individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly specified. For example, a ratio in the range of about 1 to about 200 should be understood to include the explicitly recited limits of about 1 and about 200, but also to include individual ratios such as about 2, about 3, and about 4, and sub-ranges such as about 10 to about 50, about 20 to about 100, and so forth.

[00132] Although the description herein contains many details, these should not be construed as limiting the scope of the disclosure but as merely providing illustrations of some of the presently preferred embodiments. Therefore, it will be appreciated that the scope of the disclosure fully encompasses other embodiments which may become obvious to those skilled in the art.

[00133] All structural and functional equivalents to the elements of the

disclosed embodiments that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Furthermore, no element,

component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed as a "means plus function" element unless the element is expressly recited using the phrase "means for". No claim element herein is to be construed as a "step plus function" element unless the element is expressly recited using the phrase "step for".

Table 1

Example Embodiment of RPMS Program Instructions

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Claims

What is claimed is: 1 . An apparatus for real-time post-operative or post-admission monitoring of a patient, the apparatus comprising:

(a) an electronic vital sign sensor module configured for attachment to a patient, said electronic vital sign sensor module comprising an electrocardiogram (EKG) sensor and measurement circuit configured for collecting EKG

measurements, and a plurality of sensors configured to perform multi-modality sensing with sensors for collecting bio-impedance, skin conductance, peripheral capillary oxygen saturation (Sp0₂) and photoplethysmogram (PPG), blood pressure (BP), temperature, and having at least one microphone for sound collection;

(b) a processor configured for receiving and processing sensor information from said electronic vital sign sensor module into measured patient vital sign information;

(c) a non-transitory processor-readable memory storing instructions executable by said processor, wherein said instructions, when executed by said processor, performs steps comprising:

(i) compiling one or more individual patient risk factors following a procedure, an operation, or an admission based on clinical information, and determining clinical care processing;

(ii) predicting a type and risk of one or more peri-operative or peri-admission complications based on measured patient vital sign information in relation to patient-reported information, and patient history using said clinical care processing;

(iii) electronically initiating and communicating said predicted type and risk of said one or more peri-operative or peri-admission complications to a health care provider; and

(iv) electronically initiating and communicating instructions and information back to the patient to reduce said predicted type and risk of said one or more peri-operative or peri-admission complications.

2. The apparatus of claim 1 , wherein said sound collection is configured for capturing sounds from a group of biological sounds consisting of voiced sounds, bowel sounds, breath sounds, and heart sounds.

3. The apparatus of claim 1 , wherein said electronic vital sign sensor module is further configured for collecting vital signs from the group of vital signs consisting of white blood cell count, acceleration, and range of body motion.

4. The apparatus of claim 1 , wherein said electrocardiogram (EKG) sensor and measurement circuit further comprises EKG amplifiers and filters.

5. The apparatus of claim 4, wherein said electrocardiogram (EKG) sensor and measurement circuit is configured for extracting electrode tissue impedance and a reference signal utilized in removing motion artifacts when generating a resultant EKG signal.

6. The apparatus of claim 1 , wherein said electronic vital sign sensor module is configured with photodiodes and LEDs for emitting light and capturing light reflection from the LEDs in measuring peripheral capillary oxygen saturation (Sp02) and photoplethysmogram (PPG).

7. The apparatus of claim 1 , wherein said electronic vital sign sensor module is configured for delivering a current stimulus and measuring evoked electrode overpotential in determining said bio-impedance and said skin conductance.

8. The apparatus of claim 1 , wherein different sensors, representing different sensing modalities, within said electronic vital sign sensor module can be activated independently or simultaneously through control from the processor.

9. The apparatus of claim 1 , wherein said predicted type and risk of said one or more peri-operative or peri-admission complications is electronically communicated to a health care provider based on provider communication preferences selected from the group of communication types consisting of voice message, text message, pager notification, electronic mail, internet and/or private network communications, uploaded to an intermediary communication

mechanism, or combination.

10. The apparatus of claim 1 , wherein communicating instructions and information back to the patient is performed using an electronic communications medium selected from the group of electronic communications medium consisting of voice message, text message, electronic mail, internet and/or private network communications, electronic notifications through a third party, or other notification which is electronically initiated and / or generated.

1 1 . An apparatus for real-time post-operative or post-admission monitoring of a patient, the apparatus comprising:

(a) a vital sign sensor module configured for attachment to a patient, said electronic vital sign sensor module configured to perform multi-modality sensing, including electrocardiogram (EKG) and arrhythmia, bio-impedance, skin conductance, peripheral capillary oxygen saturation (Sp02) and

photoplethysmogram (PPG), blood pressure (BP), temperature, white blood cell count, accelerometer, range of motion, with at least one microphone for patient sound collection;

(b) a processor configured for receiving and processing patient sensor information from said vital sign sensor into measured patient vital sign information;

(c) a non-transitory processor-readable memory storing instructions executable by said processor, wherein said instructions, when executed by said processor, performs steps comprising:

(i) compiling one or more individual patient risk factors following a procedure, an operation, or an admission based on clinical information, and determining clinical care processing; (ii) predicting a type and a risk of one or more peri-operative or peri-admission complications based on measured patient vital sign information in relation to patient-reported information, and patient history using said clinical care processing;

(iii) electronically initiating and communicating said predicted type and risk of said one or more peri-operative or peri-admission complications to a health care provider; and

(iv) electronically initiating and communicating instructions and information back to the patient to reduce said predicted type and risk of said one or more peri-operative or peri-admission complications.

12. The apparatus of claim 1 1 , wherein said microphone is configured for patient sound collection from patients' voice, or bowel, or breath, or heart, or combinations thereof.

13. The apparatus of claim 1 1 , wherein said electrocardiogram (EKG) comprises circuitry for extracting electrode tissue impedance and a reference signal utilized in removing motion artifacts from a resultant EKG signal.

14. The apparatus of claim 1 1 , wherein said vital sign sensor module is configured for delivering a current stimulus and measuring evoked electrode overpotential in determining said bio-impedance and said skin conductance.

15. The apparatus of claim 1 1 , wherein said vital sign sensor module is configured with photodiodes and LEDs for emitting light and capturing light reflection from the LEDs in measuring peripheral capillary oxygen saturation (Sp02) and photoplethysmogram (PPG).

16. The apparatus of claim 1 1 , wherein different sensors, representing different sensing modalities, within said electronic vital sign sensor module can be activated independently or simultaneously through control from said processor.

17. The apparatus of claim 1 1 , wherein electronically initiating and communicating said predicted type and risk of said one or more peri-operative or peri-admission complications to a health care provider is performed based on provider communication preferences selected from a group of communication types consisting of voice message, text message, pager notification, electronic mail, internet and/or private network communications, uploaded to an intermediary communication mechanism, or combination.

18. The apparatus of claim 1 1 , wherein said electronically initiating and communicating instructions and information back to the patient is configured for to communicate these instructions and information through an electronic medium selected from a group of electronic medium consisting of voice message, text message, electronic mail, internet and/or private network communications, electronic notifications through a third party, or other notification which is electronically initiated and / or generated.

19. A method for predicting type and risk of peri-operative or peri- admission complications, the method comprising:

(a) attaching a processor-enabled vital sign sensor device to a patient for collecting patient sensor information and for recording and transferring patient- reported information;

(b) transferring said patient sensor information and said patient-reported information from said processor-enabled vital sign sensor device to a computer processor;

(c) compiling individual patient risk factors on a computer processor and associated memory following each procedure, operation, or admission based on clinical information to construct a clinical care algorithm;

(d) predicting a type and a risk of one or more peri-operative or peri- admission complications on the computer processor based on collected patient sensor information, patient-reported information in relation to patient history using said clinical care algorithm;

(e) communicating from the computer processor said predicted type and risk of said one or more peri-operative or peri-admission complications to a health care provider; and

(f) communicating instructions and information from said computer processor back to the patient to reduce said predicted type and risk of said one or more peri-operative or peri-admission complications;

(g) wherein said method is performed by executing instructions, on said computer processor, said instructions residing in a non-transitory memory readable by said computer hardware processor.

20. The method of claim 19, wherein said processor-enabled vital sign sensor device is configured for collecting patient vital signs comprising

electrocardiogram (EKG), bio-impedance, skin conductance, peripheral capillary oxygen saturation (Sp02), photoplethysmogram (PPG), blood pressure (BP), temperature, and at least one microphone for sound collection of bowel, breath and heart sounds.