A system and method for monitoring biomarkers as a function of breath

Abstract

A system for monitoring a need for mind body interventions includes a first sensor. The first sensor is worn by a user for monitoring breath rate, and at least one of a user heart rate and blood oxygen level, and outputting an objective data set corresponding thereto. A second sensor receives a user input subjective data. The subjective data includes at least one of environmental data, self-reported mental state, and activity status, and outputting a subjective data set as a function thereof. A clock tracks time and outputs a clock signal as a function thereof. A platform receives the objective data set from the first sensor, the subjective data set from the second sensor and combines the first data set and the second data set when received. The platform receiving the time from the clock and time stamping the combined data set.

Description

A SYSTEM AND METHOD FOR MONITORING BIOMARKERS AS A FUNCTION OFBREATHCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 587,201 filed October 2, 2023, the entirety of which is incorporated by reference herein as if fully set forth.BACKGROUND OF THE INVENTION

[0002] The present invention is directed to a structure and method for monitoring breathing and heart rate in real time and more particularly, combining such objective data with subjective data to monitor biomarkers for an individual in real time.

[0003] Historically, respiratory trials have been associated with significant implications. The intricate nature of these trials, requiring specialized equipment, trained personnel, and often extended durations, has led to escalating costs. These challenges have inadvertently limited the frequency and diversity of such trials, potentially affecting the comprehensiveness and applicability of the data obtained.

[0004] Traditional methodologies have leaned heavily on certain auditory and observational biomarkers, such as auscultation of a patient's chest or manual counting of respiratory rates. While these methods have provided foundational insights, they often lack the precision and consistency required for real-time monitoring. The subjective nature of such observations, combined with potential human error, can introduce variability in the data collected.

[0005] The respiratory rate has long been recognized as a pivotal physiological parameter. Beyond its basic role in respiratory physiology, it serves as an indicator for various clinical outcomes. Elevated or decreased respiratory rates can be indicative of underlying pathologies, potential fatality risks, or imminent clinical events like cardiac arrest. However, continuous and accurate monitoring of this parameter, especially in non-clinical settings, has remained a challenge.

[0006] Traditional monitoring technologies, while groundbreaking for their time, often faced limitations. Many required tethered systems, continuous power sources, or frequent calibrations to maintain accuracy. The need for specialized equipment and expert oversight made continuous, real-time monitoring, especially outside clinical settings, a logistical challenge.

[0007] Earlier monitoring devices, while innovative, often faced design challenges that affected patient compliance. Bulky designs, discomfort during prolonged wear, or the need for frequent adjustments often led to inconsistent usage. This inconsistency introduced gaps in the data, reducing the overall reliability and utility of the collected information. By way of example, it is known in the art from US Patent No. 6,363,772 to detect biological conditions from monitoring breath. However, this prior art method is using complex gaseous analysis to try and detect disease. The result is a complex device which must be positioned on the patient to directly capture the exhaled breath. The prior art suffers from the disadvantage that it is cumbersome, intrusive and not designed for long term use for monitoring, so its ability to detect non disease conditions is limited.

[0008] These earlier monitoring devices, while innovative, often faced design challenges that affected patient compliance. Bulky designs, discomfort during prolonged wear, or the need for frequent adjustments often led to inconsistent usage. This inconsistency introduced gaps in the data, reducing the overall reliability and utility of the collected information.

[0009] With respect to psycho / physiological conditions, treatment options, including psychotherapy, medications, and associated interventions, have been developed to reduce anxiety's emotional and physical impacts. Interventions have been used to combat a myriad of health conditions, including anxiety, asthma, and chronic pain. Many therapies involve breathing techniques that affect parasympathetic and central nervous system activity, resulting in effective emotional control and psychological well-being.

[0010] Studies have shown that cardiovascular and respiratory effects are two primary target areas for monitoring conditions such as anxiety. Respiratory changes are diagnostic for panic disorder, further indicating their relationship with anxiety. Yet, these conditions are diagnosed, treated, andevaluated by acquiring the individual's subjective experiences. Tracking measurable, objective physiological (cardio-respiratory) data acquired before, during, and after such interventions must be correlated with subjective experiences to determine the most effective interventions based on individual needs.

[0011] Research into the application of interventions towards improving well-being while reducing stress has demonstrated their effectiveness, yet the research lacks physiological data on a large scale from real-world activities necessary to withstand scrutiny. The prior art research and treatment suffers from the fact that there is a lack of real-time objective biofeedback, including breathing patterns, during stressors to provide evidence to support the application and efficacy of interventions or therapies. Without a large (for statistical confidence and predictive power) dataset on these correlations, it is difficult to assess and compare the impacts of different interventions and quantify the efficacy of each practice in real-world settings.

[0012] While some systems in the past focused on collecting vast amounts of data, the prior art approaches and devices often lacked the capability for effective data integration and analysis. Combining subjective feedback with objective physiological data requires new approaches to ensure that the insights derived are both accurate and clinically relevant.

[0013] The potential of predictive analysis in healthcare is vast. However, realizing this potential requires not just data, but a system and method for capturing and utilizing high-quality, continuous data. Earlier systems, while capable of collecting data, often lacked the granularity or continuity required for effective predictive modeling.

[0014] The prior art further suffers from the disadvantage that it has not provided, and cannot provide, a reliable and valid physiological-psychological mapping from a large dataset for professionals to prescribe the best-use corrective practices. No known commercial technology to date has been developed to address the larger data problem using biodata, subjective data, and breathing patterns as a biomarker. These points are needed to increase the adoption, evaluation, and validation of any interventions.

[0015] Furthermore, existing systems lack the ability to manage sensors remotely, resulting in high operational costs, limited scalability, and poor reusability. These systems do not support real-time configuration, which hinders their effectiveness in large-scale, real-world applications. Additionally, the absence of adaptive algorithms to filter data points prevents efficient data processing, further increasing costs and limiting versatility across different test cases.

[0016] Accordingly, a structure and methodology which overcomes the shortcomings of the prior art is provided.SUMMARY OF THE INVENTION

[0017] A system for monitoring breath to determine biomarkers includes a first sensor. The first sensor is worn by a user for monitoring, among other things a breath rate of the user, and one of a heart rate of the user and a blood oxygen level of the user, and outputting an objective data set corresponding thereto. A second sensor for receiving user input subjective data. The subjective data includes at least one of environmental data, a self-reported mental state, and an activity status, and outputting a subjective data set as a function thereof. A clock tracks time and outputs a clock signal as a function thereof. A platform receives the objective data set from the first sensor and the subjective data set from the second sensor and combines the first data set and the second data set when received. The platform receiving the time from the clock and time stamping the combined data set.

[0018] In one embodiment of the invention the objective data may further include environmental conditions such as weather, geographical position, physical exertion, such as number of steps taken in a given time period or the like. The subjective data may include physical condition, such as dizziness, tiredness, pain level, anxiety level or the like.

[0019] In another embodiment, the first sensor is a multisensor device worn against the skin of the user. The first sensor may be formed as two pieces such as a first multi sensor worn about the chest, and a second sensor in the form of a smartwatch capable of measuring heart rate,blood pressure, number of steps, or the like, and detecting physical position, a fall or the like. The first sensor may be a smart phone or other type of device capable of receiving inputs, such as mood, event history, or the like as input from the user.

[0020] In another embodiment of the invention an article of clothing worn about the torso includes a pocket. The first sensor is disposed in the pocket, the pocket maintaining the first sensor in facing relationship with the torso of the wearer.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present disclosure will be better understood by reading the written description with reference to the accompanying drawing figures in which like reference numerals denote similar structure and refer to like elements throughout in which:

[0022] Fig. 1 is a block diagram of a system for monitoring a system for mind body interventions constructed in accordance with the invention;

[0023] Fig. 2 is a perspective view of a sensor for producing objective data about a user in accordance with the invention;

[0024] Fig. 3 is a plan view of a sensor for producing subjective data about a user in accordance with the invention;

[0025] Fig. 4 is an operational diagram of a system for monitoring and processing the subjective and objective data in accordance with the invention;

[0026] Fig. 5 is an exemplary display displaying data in accordance with the invention;

[0027] Fig. 6 are breathing patterns corresponding to sensed breathing at the objective sensor in accordance with the invention;

[0028] Fig. 7 is a top perspective view of a device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention;

[0029] Fig. 8 is a side elevation view of the breath simulator device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention;

[0030] Fig. 9 is a top plan view of the device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention in an inhale state;

[0031] Fig. 10 is a top plan view of the device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention in the exhale state;

[0032] Fig. 11 is a top perspective view of a device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention with the sensor in situ;

[0033] Fig. 12 is a side perspective view of the device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention with the sensor in situ;

[0034] Fig. 13 is a top perspective view of the device for testing and calibration of the sensor for producing objective data constructed in accordance with the invention with the sensor in situ;

[0035] Fig. 14 is a perspective view of an embodiment of the invention in which a sensor for producing objective data is used to audibly monitor breath;

[0036] Fig. 15 is a side elevation view of an embodiment of the invention in which the sensor for producing objective data is used to audibly monitor breath;

[0037] Fig. 16 is a front elevation view of a garment constructed in accordance with the invention;

[0038] Fig. 17 is a side elevation view of a garment constructed in accordance with the invention;

[0039] Fig. 17a is an exploded view of the zipper closure of Fig. 17 constructed in accordance with the invention;

[0040] Fig. 18 is a side elevation view of a garment constructed in accordance with the invention showing the device retaining structure in phantom;

[0041] Fig. 19 is a front elevation view of a sensor constructed in accordance with another embodiment of the invention;

[0042] Fig. 20 is a sectional view taken along line 20-20 of Fig. 19;

[0043] Fig 21 is a side perspective view of a sensor assembly constructed in accordance with still another embodiment of the invention;

[0044] Fig. 22 is a side perspective view of a sensor assembly constructed in accordance with the still another embodiment of the invention; and

[0045] Fig. 23 is a front elevation view of the sensor assembly, in use, constructed in accordance with still another embodiment of the invention.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Reference is first made to FIG. 1 in which a system, generally indicated as 100, for monitoring breathing and heart rate in real time and more particularly, combining such objective data with subjective data to monitor for biomarkers indicative of a condition of the wearer is provided. System 100 includes a first sensing device 200 for sensing physiological body conditions such as respiratory (breath) rate, heart rate in beats per minute, and blood oxygen saturation in a preferred non limiting embodiment. First sensing device may also use these inputs to determine a heart rate variability.

[0047] First sensing device 200 outputs the monitored physiological body conditions and outputs objective data as a function thereof. First sensing device 200 may communicate with another sensing device 250, such as a smart watch, which senses physiological and other objective data about a user, such as distance travelled, geological location, or some of the physiological conditions discussed above which smart watches measure as known in the art.

[0048] A second sensor 300 receives user inputs and outputs subjective data. Sensor 300, as will be discussed in greater detail below, receives user data as input by the user which is stored as subjective data. In a preferred nonlimiting embodiment, sensor 300 is a smart phone having a graphical user interface. In a preferred non limiting embodiment, sensor 300 may be in Bluetooth® communication with first sensor 200 and / or second sensor 250.

[0049] A platform 500 communicates, preferably through cloud 400, with first sensor 200 and second sensor 300 and receives the objective and subjective data as inputs. In a preferred embodiment communication is through cloud 400 as known in the art. In a preferred non limiting embodiment, sensor 200 and sensor 250 communicate with sensor 300, which in turn, particularly in a smart phone embodiment, transmit all data discussed below to platform 500 for processing. Platform 500 utilizes a clock signal input from one of an independent clock, a clock on objective sensor (smartwatch) 250, but in the preferred non limiting embodiment, the clock on smart phone embodiments of sensor 300. A clock may be on the platform 500 itself.

[0050] As will be described in greater detail below, platform 500 receives the objective data from sensor 200 in real time periodic intervals. Platform 500 receives the subjective data from sensor 300 in real time periodic intervals and marries the subjective data to the objective data in real time as received. An input from the clock is used to time stamp the married data. The time stamped data is saved at platform 500 for use in determining the need for, and effectiveness of, corrective actions.

[0051] In one preferred, non4 uniting application for the use of the time stamped data, professionals 702- 706 who create interventions for individuals, and monitor their effectiveness, seek access to the time stamped data. These professionals 702-706 access platform 500 through the cloud 400 via portal 700.

[0052] Reference is now made to Fig. 2 where sensor 200 is described with more particularity. Sensor 200 uses a sensor to capture diaphragmatic breathing. In other embodiments sensor 200, as will be described below may also measure pulse, and heart rate. In a preferred embodiment sensor 200 is worn against the body of a user. Sensor 200 includes a strap 204 for attaching the sensors to the body, preferably about the thoracic chest area; more particularly over the top of the lower ribcage, off centered to the right side, above the abdomen. A sensor housing 206 for mounting sensors to strap 204 supports a breath sensor 210, and may also support a heart rate and oxygen sensor 220 in an orientation for sensing breath rate and capacity, heart rate and blood oxygen levels among other physical parameters. It is also within the scope of the invention that heart rate and oxygen sensor 220, and other sensors, are housed separately from breath sensor 210.

[0053] Sensor 200 includes a transmitter (not show, but as known in the art). It is well within the scope of the invention for sensor 200 to communicate with cloud 400, but preferably the onboard transmitter is a Bluetooth* transmitter in communication with another device, such as sensor 300, in the form of a smart phone, in one non limiting embodiment, which is in communication with cloud 400. In a preferred, non-limiting embodiment, sensor housing 206, is small, less than two inches wide, weighing less than one ounce and rechargeable; preferably by magnetic induction. In this way, over time sensor 200 becomes imperceptible to the wearer.

[0054] Reference is now made to Figs. 14, 15 in which an alternative embodiment of the first sensing device, generally indicated as 1200, is provided. While sensing device 200, may include a microphone, sensing device 1200 includes a specific microphone and filter assembly capable of detecting anddetermining breathing sounds from as far away as up to about 30 centimeters. Sensor 1200 includes a housing 1210 having a high gain microphone 1212 disposed at least partially on an outer surface of housing 1210. A noise filtering device is disposed within housing 1210 to receive the sound signals and filter non breath sounds such as talking, wind or the like. A clip 1214 extends from housing 1210.

[0055] During use, clip 1214 is used to secure sensing device 1200 to a garment 1400 of a user 1300. Sensing device 1200 is secured to the top 1400 at a distance sufficiently close to user 1300 to audibly sense air flow from the nostrils of user 1300; preferably about 30 cm or less. The signals are transmitted to platform 500 for processing as discussed below.

[0056] Reference is made to Figs. 21-23 in which still another embodiment of the invention is provided. In this embodiment, microphones are strategically placed against the chest cavity of the wearer. More specifically an objective sensor, generally indicated as 1720, includes a first acoustic sensor 1722, which in a first non-limiting embodiment, is an acoustic diaphragm for sensing sounds such as breath and heartbeat within the chest cavity of user 1700. The first acoustic sensor 1722 is connected to a controller 1724 by a wire 1726. Controller 1724 processes the acoustic waves sensed by first acoustic sensor 1722. A second acoustic sensor 1727 is connected to the controller 1724 by a wire 1728. Controller 1724 processes the acoustic waves sensed by the second acoustic sensor 1727.

[0057] As can be readily ascertained, wires 1726, 1728 can be used to position sensors 1722, 1727 at the appropriate position against the body of user 1700. Sensors 1722, 1727 are preferably high gain microphones to capture sounds within the body of user 1700. As such, sensor 1720 captures internal bodily sounds through the dual sensor structure. It should be noted that objective sensor 1720 may also be used by positioning one sensor, sensor 1722 by way of example on a front of the torso of user 1700, andthe second sensor, sensor 127 on the back of the user 1700; monitorl 700 the breathing and heart patterns across the torso of user 1700.

[0058] In a preferred non limiting embodiment, sensors 1722, 1727 include a diaphragm which transfers sound to a high-resolution microphone and additional sensors for supplementary physiological data. The microphone records heart sounds and respiratory patterns, while additional sensors may gather data such as skin temperature and body movement. Controller 1724 houses a rechargeable battery and the processing electronics.

[0059] Reference is now made to Figs. 19, 20 in which an objective data sensor 1510 constructed in accordance with another embodiment of the invention is provided. Sensor 1510 includes an elastic strap 1511 for encircling the torso of a user 1500. Strap 1510 is worn by the user and is sufficiently snug such that elastic strap 1511 expands with each inhale of breath without interfering with breathing or causing discomfort. A first piezo sensor 1512a is affixed to strap 1510 on a surface away from the wearer facing surface of strap 1511. A second piezo sensor 1512b is affixed to strap 1510, spaced form first piezo sensor 1512a, on the surface away from the wearer facing surface of strap 1511. During use, strap 1511 is disposed about user 1500 so that first sensor 1512a and second sensor 1512b are equidistant from a center line of the chest cavity of the user. A non-elastic strap is affixed across first piezo sensor 1512a and second piezo sensor 1512b to sandwich across first piezo sensor 1512a and second piezo sensor 1512b between elastic strap 1511 and non-elastic strap 1518. In this way as elastic strap 1511 expands, movement of piezo sensors 1512a, 1512b is constrained by non-elastic strap 1518, causing compression piezo sensors 1512a, 1512b corresponding to the force applied, which in turn corresponds to the fullness of breath expanding the chest of the user. In effect the differential lung activity on both sides of chest of user 1500 is measured.

[0060] In a preferred, non-limiting embodiment a controller 1514 is in communication with piezo sensors 1512a, 1512b. Controller 1514 processes the piezoelectric signals from piezo sensors 1512a, 1512b and outputs corresponding breath signals. Controller 1514 may be disposed on non-elastic strap 1518 as shown in Fig. 18, or may be wirelessly connected to a controller 1514 disposed in pocket 1410.

[0061] As discussed above a portion of the functionality, as well as additional functionality, in each of these embodiments, may be provided by a smart watch type sensor 250 in communication with one of cloud 400 and / or sensor 300.

[0062] Reference is now made to Fig. 3 in which a second sensor 300 for receiving and tracking subjective data in accordance with the invention is provided. Sensor 300 is a practitioner crafted selfreporting input device and tracking device. One type of input 310 enables a user to select inputs 310a- 3 lOn describing a specific condition experienced by the user, such as numbness, dizziness, tiredness, anxiety, fogginess, or emotional conditions such as anxiety, sadness, detached or fidgety. The inputs to input 310 are binary, the condition exists and is sensed by the user, or it is not. These inputs are input periodically by the user, particularly as conditions may change.

[0063] In a section 320, analog input section 320, a user may input the relative perceived level of their condition as part of a sliding scale for one, any ones, or all of the subjective categories discussed above. The scale may be set by a third party, such as the practitioner 702, in one embodiment as a function of granularity. For example, the user may input how tired they are on a scale from 0 to 10; 0 being wide awake and 10 being falling asleep.

[0064] In a section 330, a user may give greater particularity regarding their condition, or even potential causes, as activity data, such as an accident, a scare, physical exertion, even sitting down for an exam by manually or orally entering a description of their current state. Lastly, a user may take and download photos of a condition in a photo receiving section 340 of sensor 300. In a preferred, non-limiting, embodiment sensor 300 is a smart phone capable for receiving the inputs described above and communicating with cloud 400.

[0065] A save button 350 is provided to save the periodic entries at first to sensor 300, but also as a trigger to transmit the data received at sensor 300, including any data received from sensor 200 and / or sensor 250, preferably with a time stamp. It should be noted that objective data from sensor 200 is transmitted periodically by sensor 300, regardless of the existence of new subjective data, enabling the monitoring of physiological conditions in real time as will be discussed below.

[0066] Reference is now made to Fig. 4 in which system 100, including a platform 500 for operating on the subjective and objective inputs is provided. Platform 500 receives the objective data as transmitted from subjective sensor 300 and if not, already time stamped, time stamps the data and marries the objective data inputs to the subjective data inputs at periodic stamped intervals. In this way a change in the physiological data can be interpreted in light of the subjective state and environment of the user.

[0067] As seen objective sensor 200 monitors a number of biological factors, as objective data 213, through a number of sensors such as a temperature monitor 212, an oxygen volume monitor 208, a heart rate monitor 220, and breath rate monitor 210. Sensor 200 may include a microphone 214 for recording breath and ability to talk, among other thing as well as a gyroscope 216 and accelerometer 218 to detect whether the monitored person is climbing in altitude, is walking, running or standing still, and even if themonitored person has fallen. As seen in Fig. 6, at a minimum breath rate monitor 210 receives the breath rate as a time frequency graph which indicates rest, aerobic activity, anerobic activity, pain and anxiety, recognizable by system 100.

[0068] Subjective sensor 300 utilizes user inputs into a smart phone or the like as discussed above, and receives user inputs and photos and videos 340, comments 360 regarding current condition, a location such as GPS input from GPS sensor 304, and previously stored, or currently created files 302 regarding current or created conditions. User inputs may also include prior medical data 312, the current weather 316, as determined by the user, or as pulled from a weather website, an air pollution indicator 318, as determined by the user, or as pulled from a weather website, or social events 319 in put by user describing their current activity.

[0069] As described above the data received by objective sensor 200 is collected in real time. The data collected by subjective sensor 300 is transmitted as collected. Both may be time stamped by respective sensors 200, 300 or in a preferred , non-limiting embodiment, are received by a clock 370, which applies a time stamp joining both, and when location data is received from sensor 300, location stamps the data.

[0070] Platform 500 receives the data which, as a result of the time geography stamp links at linker 600 environmental data, the time stamped subjective data and objective data, and as a result of inputs from both objective sensor 200 and subjective senor 300 and provides context.

[0071] Platform 500 utilizes artificial intelligence analysis 620 and human analysis 600 to process the data set. The analysis results in a biomarker and biomarker identification 624. A computer 700 receives the biomarker and biomarker identification 624 and develops a data model 670 for indicator 628. In onenon limiting embodiment, as discussed below, platform 500 may determine a corresponding intervention 626.[0072J In the non-limiting embodiment, practitioners 702-706 are the types of professionals who recommend mind body interventions to help control certain behaviors. These may be physicians, psychiatrists, psychologists, even meditation instructors. Each practitioner 702-706 accesses the data at a respective portal device, such as a computer 700 (only one being shown for simplicity). Computer 700, acting in accordance with the developed data model 670 and determined intervention 628, will allow access to the combined, time stamped, objective data and subjective data. By observing the data, a practitioner 702-706 can create, or alter existing, mind body interactions for correcting any abnormality in the objective data as a function of the potential cause from the subjective data. Computer 700 may receive the data in a pull method, requiring practitioner 702-706 to request the data. Alternatively, platform 500 may periodically push the data to identified practitioner 702-706 regardless of change, or platform 500 may monitor for changes in physiological conditions in a user, and when changes exceed a predetermined range push an alert to the appropriate practitioner 702-706. In effect creating an early warning system of a need for a particular type of intervention, if any.

[0073] As seen in Fig. 5 as a result of what is sensed at objective sensor 200, respiratory rate 810, breath wave 812 and heart rate 814 biodata may be monitored in real time at portal 700 and is displayed at a display 800 to facilitate monitoring and analysis. The data may be recorded for storage under control of a record input 818, until monitoring is stopped at stop tab 800. For example, as shown in Fig. 6, various monitored breath rates are shown indicative of specific physical conditions experienced by the wearer.

[0074] Software portal(s) 700 creates an end-to-end experience for practitioners, users, professionals, and researchers, enabling the innovation cycle for respiratory needs, tools, and mind and body interventions. Users remotely connect with professionals and / or professional-created practices to track, record, and share data. The system provides novel, proprietary algorithms to analyze and interpret subjective and objective data using Al machine learning. The software enables researchers to develop different models that can be used as early warning indicators, predictive analytics, and generalized standards for different health conditions such as anxiety, asthma, and cardiac arrest.

[0075] As with any monitoring, calibration for accuracy is key. As seen in Figs. 7-9, a breath simulator, generally indicated as 1000, is used to calibrate first sensing device 200. Breath simulator 1000 includes a platform 1006. A cam 1004 is rotatably disposed at a center position of the base 1006. A plurality of sliders 1002a-1002d are each individually in contact with cam 1004 at a respective first end 1008a-1008d thereof and are slidably disposed on base 10006. Each respective cam 1002a-1002d has an outward facing curved surface lOlOa-lOlOd away from cam 1004. Outward facing curved surfaces lOlOa-lOlOd are preferably wider than first ends 1008a-1008d and exhibit a fan, or mushroom shape. In a preferred non limiting embodiment, each of cams 1002a-1002d is mounted on a respective bearing 1012a-d to facilitate reciprocating movement of each of cams 1002a-1002d along platform 1006 between cam 1004 and an outer edge of platform 1006. A motor 1008, preferably mounted on an underside of platform 1006, is operatively connected to cam 1004 to operate cam 1004.

[0076] As seen in figures 7,8 and 11- 13, a first sensing device 200 is mounted on an elastic band 204 about cams 1002a-1002d, preferably when cams 1002a-1002b are in the inhale state as seen in Fig. 9. Cam 1004 is then activated by motor 1008 and slides each of cams 1002a-1002b away from each other and towards the edge of platform 1006; simulating the state at exhale. In this state elastic band 204 is expanded in the directions away from first sensing device 200 as shown by arrow A and B of Figs, 11, 12; activating the pressure sensitive sensors of first sensingdevice 200 as described above. Knowing the force applied by cams 1002a-1002b, it can be compared to the force indicated by sensor 200 to calibrate sensor 200.

[0077] Placement of the sensors relative to the body should be consistent for best results and comparisons. Additionally directly attaching the sensors to the body may cause discomfort over time. Reference is now made to Figs. 17-18 in which a garment, constructed in accordance with the invention, for securing the device relative to the body is provided. The garment enhances data consistency and comfort. Like numerals are used to indicate like structure, a top 1400, such as a shirt or a blouse, is configured to hold and maintain the first sensing device 200, including housing 206 and band 204.

[0078] Top 1400 is formed with at least one pocketl408a at a position corresponding to a preferred monitoring position for sensor 206a, and is sized to receive and retain sensor 206a therein. A patch 1406a, shown in phantom, extends across the interior surface of garment 1400 to prevent any crimps in the material from being seen on the outer surface of garment 1400 during use.

[0079] A pocket 1408a is formed between a portion of patch 1406a and garment 1400. Pocket 1408a receives a sensor 206 therein. In a preferred non limiting embodiment, when top 1400 is worn, pocket 1408a is disposed at an optimum position for placement of sensor 206 relative to the body of a user. An opening, releasably closed by a zipper 1412a is disposed on an exterior surface of top 1400 to provide access to the sensor 206a for repair, replacement, or adjustment.

[0080] For embodiments where a second sensor 206b is utilized , a second pocket 1408b, disposed with a patch 1406b, accommodates a second sensor 206b. A zipper 1412b provides access to pocket 1408b from the exterior of top 1400. Both pockets have slits therein for accommodating band 204 of sensor 200. In one contemplated embodiment, the pocket may besealed with a Velcro® closure. An inner sleeve (not shown) may be provided to keep band 204 from contacting the skin of the user, when the band is inside garment 1400.

[0081] Additionally, the pocket 1408 on the interior of top 1400 forces top 1400 to lay over sensor 200 in a way that conceals sensor 200. By retaining interior pocket 1408 against the body of the user, the top 1400 will not exhibit discontinuities, and therefore the existence of sensors 200 will not be seen through top 1400. In other words the pocket structure enables concealment of the sensors from the rest of the public.

[0082] A pocket 1410 is disposed in collar 1404 formed on top 1400. A local control module (not shown) may be disposed in pocket 1410 for local monitoring and control of sensors 206a, 206b or the like.

[0083] By utilizing the pocket construction described above, garment 1400 conceals the sensor, offering discreet appearance, enhancing comfort and prolonging use. Additionally, the garment can now distribute the weight of the sensor evenly while positioning the sensors to provide consistent readings.

[0084] Garment 1400 may be adapted to a number of embodiments of the inventive objective sensor. By way of example, objective sensor 1720 may be supported by garment 1400, with controller 1724 being disposed within pocket 1410. Pockets having structure similar to pockets 1408, would be repositioned within garment 1400 to correspond to the desired placement position of sensors 1722, 1727.

[0085] As can be seen from the above, a digital health platform that develops a real-world evidence-based data collection system for respiratory and cardiovascular monitoring and analysis is provided. The platform is focused on identifying distinctive breathing patterns associated with biomarkers, such as anxiety, or the like. This enables the creation of automated alerts as an early warning system. This system may be used by professionals to deliver interventions in real-time to users to reduce the duration and intensity of anxiety episodes and other health conditions.

[0086] Monitoring breath related biomarkers provides a comprehensive perspective on health conditions and trends. By unraveling the meaning behind sound and motion patterns, the abovedescribed invention creates an opportunity for enhanced healthcare management and interventions that encompass both physiological and psychological dimensions.

[0087] As a result of the above system and use a platform to collect subjective experiences and cardio-respiratory biodata for an early warning health indicator will drive changes in intervention methodologies, treatments, services, adoption, and preventative interventions for anxiety and other health conditions. Better data will result in mental and physical health benefits for a large population, expand the reach of health professionals and interventions, and decrease associated social and economic healthcare costs.

[0088] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained and, since certain changes may be made in carrying out the above method and in the construction set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

[0089] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

Claims

CLAIMS1. A system for creating biomarkers as a function of sensed user characteristics comprises: a first sensor, the first sensor configured to be worn by a user for monitoring a breath rate of the user, and out putting an objective data set corresponding thereto; a second sensor configured to receive a user input subjective data, the subjective data includes at least one of environmental data, a self-reported mental state, and an activity status, and outputting a subjective data set as a function thereof; a clock, the clock tracking time and outputting a clock signal as a function thereof; and a platform, the platform receiving the objective data set from the first sensor and the subjective data set from the second sensor and combining the first data set and the second data set when received, the platform receiving the time from the clock and time stamping the combined data set and creating a biomarker as a function of the objective data set and subjective data set.

2. The system of claim 1, wherein the platform determines an intervention as a function of the biomarker.

3. The system of claim 1, wherein the first sensor is disposed against a body of the user.

4. The system of claim 1, wherein the first sensor is at least on of an acoustic diaphragm, a blood pressure monitor, heart rate monitor, breath rate monitor.

5. The system of claim 1, further comprising a strap configured to encircle a body of the user, the first sensor being disposed on the strap.

6. The system of claim 1, further comprising a garment, the garment positioning the monitoring device being worn by a user for monitoring the breath rate of the user.

7. The system of claim 1, where in the subjective data further comprises at least one of physical condition and an emotional condition.

8. The system of claim 1, wherein the platform is configured to output an alert to a practitioner when the platform determines that a change in the biomarker exceeds a predetermined threshold.

9. The system of claim 1, wherein the first sensor further monitors at least one of a heart rate of the user and a blood oxygen level of the user; the objective data further comprising at least one of the heart rate of the user and the blood oxygen level of the user,10. The system of claim 1, wherein the platform is configured to enable a practitioner to remotely adjust a scale enabling the platform to measure the subjective data.

11. The system of claim 2, wherein the platform is configured to enable a practitioner to remotely change the intervention as a function of at least one of the objective data set and subjective data set.

12. A calibration device for calibrating a monitoring device, the monitoring device being worn by a user for monitoring at least a breath rate of the user, the calibration device comprising: a platform; a cam rototably disposed on the platform; at least two sliders, each slider being slidably disposed on the platform; each slider having a first end and a second end, the first end of each slider being in contact with the cam, the second end of each slider facing in a direction away from the cam; each cam moving along the platform towards an outer edge of the platform, upon rotation of the cam; the sliders being oriented to receive a strap about a circumference formed by the second end of the at least two sliders.

13. The calibration device of claim 11, wherein the second end of each slider exhibits a curved surface.

14. The calibration device of claim 11, wherein the second end of each slider exhibits a mushroom shape.

15. A garment for positioning monitoring device being worn by a user for monitoring a breath rate of the user relative to the user comprising: a top; at least one patch extending across an interior surface of the garment, pocket formed on an interior surface of the top; the pocket being formed between a portion of the patch and the interior surface of the garment; the pocket providing access form an exterior surface of the top and being sized to receive the monitoring device therein, and being positioned at a position to optimize monitoring of a wearer by the monitoring device; the pocket being capable of being releasably closed.

16. The garment of claim 14 wherein the monitoring device comprises: a first sensor, the first sensor configured to be worn by a user for monitoring a breath rate of the user, and at least one of a heart rate of the user and a blood oxygen level of the user, and out putting an objective data set corresponding thereto; a second sensor configured to receive a user input subjective data, the subjective data includes at least one of environmental data, a self-reported mental state, and an activity status, and outputting a subjective data set as a function thereof; a clock, the clock tracking time and outputting a clock signal as a function thereof; anda platform, the platform receiving the objective data set from the first sensor and the subjective data set from the second sensor and combining the first data set and the second data set when received, the platform receiving the time from the clock and time stamping the combined data set and creating a biomarker as a function of the objective data set and subjective data set.

17. The system of claim 115, wherein the platform determines an intervention as a function of the biomarker.

18. The system of claim 15, wherein the first sensor is at least on of an acoustic diaphragm, a blood pressure monitor, heart rate monitor, breath rate monitor.

19. The system of claim 15, where in the subjective data further comprises at least one of physical condition and an emotional condition.

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