WO2022218502A1

WO2022218502A1 - Medical device measuring health parameters

Info

Publication number: WO2022218502A1
Application number: PCT/EP2021/059450
Authority: WO
Inventors: Gabriel KADJO; Philippe BASMACIOGLU
Original assignee: Kadjo Gabriel; Basmacioglu Philippe
Priority date: 2021-04-12
Filing date: 2021-04-12
Publication date: 2022-10-20

Abstract

A medical device including a cuff configured to be placed around a user's left arm, an interface module coupled to the cuff, and a flap coupled to the cuff and the interface module. The flap is configured to make contact with the user's chest. The interface module includes a user interface and a communications module configured to communicate over a wireless network. The cuff and the flap include a plurality of sensors including 12-lead electrocardiogram (ECG) sensors. The plurality of sensors also includes a body temperature sensor, a blood pressure sensor, a 4-wire bio-impedance sensor, and a blood oxygen saturation sensor.

Description

MEDICAL DEVICE MEASURING HEALTH PARAMETERS

FIELD OF THE INVENTION

[0001] The present invention pertains to the field of medical devices, and in particular to an integrated medical device for measuring seven health parameters of a human user.

BACKGROUND

[0002] There currently exists a wide variety of medical devices and health gadgets on the market to enable users or health professionals to monitor and record many different health parameters. Some medical devices monitor only one health parameter while others monitor a number of health parameters. Monitoring results may be displayed and recorded on the device or communicated externally to the device. Unfortunately, many medical devices operate disconnected from each other, leaving individual users incapable of efficiently managing their health data. Difficulties arise when medical professionals are unable to collect sufficient and correlated health data to analyse in depth their users’ medical condition, which may be improving or deteriorating over time.

[0003] The situation becomes more difficult once the user has left the clinic or hospital to return home and may be required to monitor themselves using consumer medical devices. In particular, user-friendly electrocardiogram (ECG) combined with respiratory based devices are difficult to access for the layperson, despite the majority of fatal illnesses and diseases across the world being caused by cardiovascular and respiratory deteriorations.

[0004] Presently, there exists no integrated medical devices on the market that allows users to self monitor their health by capturing jointly the following key health parameters in a single measurement and in the absence of a health professional in attendance. These health parameters include body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, body fat- mass index, and 12-lead ECG. [0005] Therefore, there is a need for a method and apparatus with an integrated medical device, that captures important health parameters, that may be consistently and accurately operated by a user, that obviates or mitigates one or more limitations of the prior art.

[0006] This background information is provided to reveal information believed by the applicant to be of possible relevance to the present invention. No admission is necessarily intended, nor should be construed, that any of the preceding information constitutes prior art against the present invention.

SUMMARY

[0007] An object of embodiments of the present invention is to provide an integrated medical device that allows a user to self-monitor key health parameters in the absence of a health professional in attendance. These health parameters may include body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, body fat-mass index, and 12-lead ECG. Embodiments are intuitive to use, allowing for the accurate monitoring of health parameters without the help of trained medical staff. Monitored health parameters may be stored within the medical device for later use or may be uploaded to networked storage for access and use by authorized users such as doctors, nurses and other medical staff. Users are able to authorize access to, control, and view their data using a mobile device.

[0008] In accordance with embodiments of the present invention, there is provided a medical device including a cuff configured to receive a user’s left arm, an interface module coupled to the cuff where the interface module includes a user interface. A flap coupled to the cuff and the interface module is configured to make contact with the user’s chest. The cuff and the flap contain a plurality of sensors including 12-lead electrocardiogram (ECG) sensors.

[0009] In a further embodiment, the interface module includes a communications module configured to communicate over a wireless network.

[0010] In a further embodiment, the communications module is configured to communicate with a mobile device and a remote server. [0011] In a further embodiment, the remote server is a cloud computing service.

[0012] In a further embodiment, the plurality of sensors includes a body temperature sensor, a blood pressure sensor, a 4 wire bio-impedance sensor, and a blood oxygen saturation sensor.

[0013] In a further embodiment, the flap contains VI through V5 ECG sensors and the cuff contains a V6 ECG sensor. The cuff and the flap are configured to position the VI through V6 ECG sensors on the user’s skin to receive ECG measurements when worn by the user.

[0014] In a further embodiment, the cuff contains an LA ECG sensor on an internal surface of the cuff and the cuff is configured to place the LA ECG sensor on the user’s skin to receive ECG measurements.

[0015] In further embodiments, the cuff contains an infrared body temperature sensor on an external surface of the cuff and the cuff is configured to place the infrared body temperature sensor on the user’s skin to receive temperature measurements.

[0016] In accordance with embodiments of the present invention, there is provided a method for monitoring a user using a medical device. The method includes inserting the user’s left arm into a cuff of the medical device and tightening the cuff above the user’s left elbow. An internal surface of the cuff makes contact with skin of the user and an external surface of the cuff makes contact with skin of the user’s torso. The unrolled flap of the medical device makes contact with the skin of the lower part of the user’s breast in-line with the user’s heart. Placing the user’s right palm against the flap and placing the user’s right middle finger over a sensor on an external surface of the flap. Placing the user’s left palm on a lower right portion of the user’s abdomen and initiating the monitoring.

[0017] In further embodiments, the monitoring includes the measurement of health parameters of the user including a blood pressure, a heart rate, a body temperature, a respiratory rate, a body fat-mass index, a blood oxygen saturation, and a 12-leads ECG.

[0018] Embodiments have been described above in conjunctions with aspects of the present invention upon which they can be implemented. Those skilled in the art will appreciate that embodiments may be implemented in conjunction with the aspect with which they are described, but may also be implemented with other embodiments of that aspect. When embodiments are mutually exclusive, or are otherwise incompatible with each other, it will be apparent to those skilled in the art. Some embodiments may be described in relation to one aspect, but may also be applicable to other aspects, as will be apparent to those of skill in the art.

BRIEF DESCRIPTION OF THE FIGURES

[0019] Further features and advantages of the present invention will become apparent from the following detailed description, taken in combination with the appended drawings, in which:

[0020] FIG. 1 provides a diagram of an authentication and communication architecture for a medical device, according to an embodiment.

[0021] FIG. 2 illustrates an authentication and communication method, according to an embodiment.

[0022] FIG. 3 illustrates a front side view of a medical device, according to an embodiment.

[0023] FIG. 4 illustrates a back side view of a medical device, according to an embodiment.

[0024] FIG. 5 illustrates a view of a medical device with the cuff unrolled, according to an embodiment.

[0025] FIG. 6 illustrates views of some of the sensor components of a medical device, according to an embodiment.

[0026] FIG. 7 illustrates an exploded view of an interface module of a medical device, according to an embodiment.

[0027] FIG. 8 illustrates steps to be performed by a user to prepare to use a medical device, according to an embodiment. [0028] FIG. 9 illustrates the timing of measurements performed by a medical device, according to an embodiment.

[0029] FIG. 10 presents an illustration of the placement of a medical device when used by a user, according to an embodiment.

[0030] It will be noted that throughout the appended drawings, like features are identified by like reference numerals.

DETAILED DESCRIPTION

[0031] Embodiments of the present invention provide an integrated medical device that allows a user to self-monitor key health parameters in the absence of a health professional. These health parameters may include body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, body fat-mass index, and 12-lead ECG. Embodiments provide a medical device that is intuitive to use, allowing for the accurate monitoring of health parameters even without the help of trained medical staff. Monitored health parameters may be stored within the medical device for later use or uploaded to networked storage, such as Cloud storage, for access and use by authorized users such as the user themselves, doctors, nurses and other medical staff. Users are able to authorize access, control, and view their data using a mobile device. Confidential information may be manually or automatically deleted from the medical device after use.

[0032] Embodiments allow users to monitor their health with smart guidance from health care professionals from the comfort of their home. Users can take action as soon as any deviation from standard health baselines or from their personal health baseline is detected. This can prevent some negative health outcomes or at least significantly decrease their negative impact as soon as possible.

[0033] Embodiments may lead to less medical interventions and medical costs for users. Embodiments may also allow for optimized coordination between doctors and their patients, decrease the work burden for doctors, and lessen congestion in emergency rooms and other medical institutions. Embodiments may enable and improve the offering of healthcare screening in areas far from clinics and hospitals. Embodiments allow for more accurate monitoring of patients health which can allow for the better management of medical treatments and to lower pressure on medical resources. Furthermore, use of embodiments may lead to improved health monitoring for the chronically diseased and elderly population at risk and lowering the financial burden on national healthcare programs.

[0034] Embodiments include an arm cuff configured to be placed around the left arm of a user and a flap pressed against the user’s chest. Medical sensors are included on internal and external surfaces of the cuff and the flap. The sensors collect data to allow for the direct measurement or calculation of health parameters such as body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, body fat- mass index, and electrocardiogram (ECG), using the 12-lead method. Measurements may be completed in a sufficiently short time as to not overly inconvenience the user. In embodiment, measurements may be completed in less than two minutes.

[0035] An electrocardiogram (ECG) consists of measurements that provide an indication of the electrical conduction of the heart, detecting heart rhythm abnormalities and myocardial ischemias. By examining changes in ECG measurements, healthcare professionals can identify a multitude of cardiac disease indications. The standard ECG has 12 leads. Six of the leads are labeled “limb leads” because they are placed on the arms or legs of the user. The other six leads are labeled “precordial leads” because they are placed on the torso (precordium) of the user. The six limb leads are called lead I, II, III, aVL, aVR and aVF. The letter “a” stands for “augmented,” as these leads are calculated from the measurements of leads I, II and III. The six precordial leads are called leads VI, V2, V3, V4, V5 and V6. To obtain measurements 10 electrodes are required. Four electrodes are placed on the four limbs of the user; right arm (RA), left leg (LL), left arm (LA), and right leg (RL). The other six electrodes, VI, V2, V3, V4, V5 and V6, are placed on the precordium of the user. In embodiments, the VI through V6 sensors are applied to the user’s chest. The user places a flat portion of a finger of their right hand on the RA sensor. The LA sensor on the internal side of the cuff is placed against the bare skin of the left arm. The LL sensor is located on the lower, external surface of the cuff and is placed against the left side of the user’s chest. The RL sensors is located above the LL on the external surface of the cuff and is also placed against the left side of the user’s chest in a manner to simulate a right leg reading. The ECG sensor connections allow for the creation of the Einthoven’s triangle composed of the right arm (RA), left arm (LA) and lateral side of the torso (LL). Triangle D1 is between the RA (aVR) and LA (aVL). Triangle D2 is between RA (aVR) and LL (aVF). Triangle D3 is between LA (aVL) and LL (aVF). [0036] Oxygen saturation, which may be referred to as Sp02, is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen and may be measured using a reflective photoplethysmography (PPG) sensor. PPG is a non-invasive measurement technique that uses a light source and a photodetector at the surface of the skin to measure the volumetric variations of blood circulation. A PPG sensor may also be used to measure heart rate.

[0037] Bio-impedance sensors may be used to calculate body fat-mass index (FMI) and respiratory rate. In embodiments, four bio-impedance sensors may be provided to provide 4 wire measurements.

[0038] Embodiments may be configured or calibrated to measure using only a subset of its equipped sensors. For example, the medical device can be configured to only measure blood pressure and heart rate for users (typically hypertensive users) requiring regular measurements of these two health parameters as per their doctor’s recommendation.

[0039] Embodiments include sensors in locations to ensure correct placement for accurate readings. The integrated flap contains several of ECG sensors required to perform a 12-lead measurement as well as a PPG sensor measuring the SpCh. The flap is equipped with a magnet or other clasp on its outer edge to allow it to fold around the cuff for a user wishing to only measure their blood pressure and heart rate without measuring other health parameters.

[0040] The flap is also equipped with pressure sensors allowing the device to inform the user if they are not applying sufficient pressure or if they are applying too much pressure on the flap against their chest to ensure proper measurements. The user may be informed through a companion application (app) on a connected smartphone, tablet, or other computing device or through a light-based indication on the medical device itself. The flap is also equipped with “lead- off’ detection that will verify that if the sensors are properly connected, and immediately notify the user if a fault is detected. Finally, the medical device also includes motion sensors allowing it to notify users and health care professionals if the user is moving too much during the measurements. [0041] FIG. 1 provides a use environment to illustrate an authentication and communication architecture for the medical device, according to an embodiment. Authentication and communication with medical device 106 is done by sending a profile ID and a session token from an application running on mobile device 102 to medical device 106. Mobile device 102 and medical device 106 may be connected through a variety of wireless or wired communications protocols such as Bluetooth, including the Bluetooth Low Energy (BLE) 4.2 standard, any of the 802.11 standard or families, USB, or other protocols. Once the application commences measurement, medical device 106 will start to send data that may be formatted as JSON files via HTTPS or similar protocol to external server 104 after each measurement, which will be stored in a database. External server 104 may be a cloud storage provider such as Microsoft Azure or equivalent. Alternatively, measurement data may be sent in batches or at the end of the measurement cycle. Data may be encrypted at rest, in flight, or both at rest and in flight using standards suitable for protecting user data such as PBKDF2 and SHA-256 bits encryption. At the end of a measurement session, confidential user information may be automatically deleted from the medical device 106.

[0042] FIG. 2 illustrates an authentication and communication method, according to an embodiment. In step 202 the application on mobile device 102 sends user credentials such as a username or email, and password to remote storage 104 for authentication. In step 204, remote storage 104 will then compare the supplied credentials against a stored credentials to authenticate the user. The stored credentials may be a hash of the credentials such as produced by the BCRYPT one way hashing algorithm or other method as known in the art. If the user credentials are successfully authenticated the mobile device 102 receives a profile ID and session token. In step 206, mobile device 102 sends the profile ID and session token to the medical device. Following this, in step 208 the mobile device 102 sends a command to the medical device 106 to initiate measurements. In step 210, medical device 106 performs user measurements and sends measured data as encrypted JSON to remote storage 104 using the HTTPS protocol over an Internet connection. Each data packet received is checked for transmission errors to ensure accuracy of data. [0043] FIG. 3 illustrates a view of a medical device 106 facing away from a user’s chest (i.e., the side not in contact with the user’s chest), while FIG. 4 illustrates a view of the medical device 106 facing towards the user’s chest (i.e., the side in contact with the user’s chest), according to an embodiment. Medical device 106 includes a cuff 302 configured to be applied around a user’s left arm, an interface module 304 coupled to the cuff, including a user interface, and a flap 306 coupled to the cuff and the interface module. The flap 306 is configured to make contact with the user’s chest. The cuff 302 and the flap 306 contain a plurality of sensors including 12-lead ECG sensors.

[0044] Cuff 302 is configured to be of similar dimensions as a traditional blood pressure cuff. The cuff 302 may be partially or fully unrolled for placement around a user’s left arm above the elbow in a position to enable blood pressure measurements. A fastening means such as Velcro patches, clasps, or fasteners are included to secure cuff 302 around a user’s left arm in order to perform measurements. Cuff 302 also includes a portion for interface module 304 to be attached to and a portion for flap 306 to be attached to. Cuff 302, interface module 304, and flap 306 include electrical connections to connect electronic circuits and sensors within the medical device 106. Cuff 302 includes a number of sensors on its internal and external surfaces. An internal surface of the cuff 302 contains a sensor module 402 that includes a first bio-impedance sensor 406, and the LA ECG sensor 404. LA ECG sensor 404 also acts as a second bio-impedance sensor. The external surface of the cuff 302 includes infrared body temperature (T°) sensor 312 and sensor module 314 that includes the V6 ECG sensor 410, the RL ECG sensor 408, and the LL ECG sensor 316.

[0045] Flap 306 is physically attached to cuff 302 and interface module 304 and may be rolled around cuff 302 when not in use. When in use, flap 306 unrolls and extends to be placed against a user’s chest. Tension in flap 306 may aid in holding flap 306 against the user’s chest. Flap 306 is of a size and shape to allow for ECG sensors VI through V5 to be placed in the correct position against a user’s chest to allow for correct ECG measurements. Flap 306 may utilize a connector to be detachably coupled to cuff 302 or interface module 304 to allow for easy storage, cleaning, replacement, etc. Flap 306 may be available in a variety of shapes, lengths, and sizes to match the physical size and shape of a large variety of user body types. In an embodiment, cuff 302 and interface module 304 may be packaged with several shapes, lengths, and sizes of flap 306 to allow the device to be used on a variety of users or patients in a home or clinical environment. The side of flap 306 that is placed against a user’s chest is referred to herein as the internal surface. The side of flap 306 that is placed away from a user’s chest is referred to herein as the external surface. An external surface of flap 306 includes sensor module 318 which includes PPG sensor 324, RA ECG sensor 322, and a third bio-impedance sensor 320. RA ECG sensor 322 also acts as a fourth bio-impedance sensor. Therefore the 4 wire bio-impedance sensors to allow for the calculation of respiratory rate and body fat-mass index include bio-impedance sensor 406, LA ECG sensor 404, bio-impedance sensor 320, and RA ECG sensor 322.

[0046] When in use, a user places their palm and middle finger of their right hand to cover all three sensors, PPG sensor 324, RA ECG sensor 322, and bio-impedance sensor 320. An internal surface of flap 306 includes ECG sensors VI through V5; ECG VI sensor 420, ECG V2 sensor 418, ECG V3 sensor 416, ECG V4 sensor 414, and ECG V5 sensor 412. As illustrated, each of the ECG sensors VI through V5 include a surrounding patch with an electrode 422 within.

[0047] Interface module 304 is coupled to cuff 302 and flap 306 and includes electrical connections from the electronic circuits within interface module 304 to sensors included in cuff 302 and flap 306. In embodiments, interface module 304 may be detachable from medical device 106 for maintenance, management, or repair. Interface module 304 includes a user interface which may include on/off button 310 and a LED indicator, display, or screen 308 to provide users with feedback on the status of medical device 106.

[0048] FIG. 5 illustrates a view of medical device 106 with the cuff 302 unrolled, according to an embodiment. Cuff 302 is of similar size and shape as a blood pressure monitor cuff as is known in the art and includes fasteners such as Velcro patches, clasps, or fasteners in order to fit around a user’s arm and be secured in place for measurements. Cuff 302, interface module 304, and flap 306 may be permanently or detachably attached to each other.

[0049] FIG. 6 illustrates views of some of the sensor components of medical device 106, according to an embodiment. Sensor modules such as sensor module 314 and sensor module 318 provide groups of sensors that may be attached to the flexible material of cuff 302 and flap 306. Sensor modules provide a modular design that facilitates the manufacture, maintenance, and repair of medical device 106. Sensor modules include one or more sensors as well as electrical connectors to connect to the cuff 302, interface module 304, or flap 306. Sensor module 314 is attached to an external surface of cuff 302 and includes the V6 ECG sensor 410, the RL ECG sensor 408, and the LL ECG sensor 316. Sensor module 318 is attached to an external surface of flap 302 and includes PPG sensor 324, RA ECG sensor 322, and bio-impedance sensor 320. Temperature sensor 312 is a stand-alone module as are each of the ECG sensors, such as V5 ECG sensor 412 and the other ECG sensors VI through V4. The back surface of interface module 304 includes sensor module 402 which may be directly connected to interface module 304 or directly incorporated into interface module 304. Sensor module 402 includes bio-impedance sensor 406, and the LA ECG sensor 404.

[0050] FIG. 7 illustrates an exploded view of interface module 304 of medical device 106, according to an embodiment. Interface module 304 is contained in a casing that includes a top casing 716 and a bottom casing 702 which may be manufactured from medical grade plastics or other material suitable for medical devices. Medical device 106 is powered by a battery 704 which may be replaceable and rechargeable. In order to perform blood pressure measurements that require the inflation and deflation of the cuff, interface module includes pump 706, valve 712 and blood pressure monitor (BPM) PCB 710 that includes the electronic circuits required to control the BPM measurements. As illustrated, a second PCB, PCBA 708 includes the required electronic circuitry to control and manage the other functions of medical device 106. As is known in the art the electronic circuitry of PCBA 708 includes a process, memory, networking circuitry, power management circuitry, and interface circuitry to connect and communicate with the sensors of medical device 106. In other embodiments, the components of BPM PCB 710 and PCBA 708 may be combined onto a single PCB or divided amongst three of more PCBs. LED screen or ring 718 and on/off button 720 are integrated into the casing of interface module 304. LED ring 718 provides feedback such as the medical device status, measurement phase, etc., to the user or another observer. The assembled interface module 304 is secured to cuff 302 using mounting plate 722. [0051] The surfaces of PCBA 708 may include electronics components required to operate medical device 106. Electronics required for ECG measurement may be mounted on PCBA 708 and may include an 8-channel ECG front end. PCBA 708 may also include analog multiplexers to switch signals received from the ECG and bio-impedance sensors to the ECG circuitry or to the bioimpedance analysis (BIA) circuitry. In particular, LA ECG sensor 404 and RA ECG sensor 322 are both also used as two of the 4 wire bio-impedance sensor. Electronics required for BIA measurements may include a high precision, low power electrochemical-based measurement analog front end. An inertial measurement unit (IMU) including an accelerometer, gyroscope, magnetometer, etc. is used to perform 9-axis motion tracking of medical device 106. A main microcontroller and non-volatile memory, such as flash memory for code and parameter storage is responsible for handling the sensors and received data , to manage the network communications and to remote storage 104. Antennas are included to support wireless communications. A separate BLE microcontroller may be used to handle the BLE communication to mobile device 102, the on/off button 720, the LEDs 718, and the IMU sensors. Alternatively, a single microcontroller may combine the functionality of the main microcontroller and the BLE microcontroller. Finally, PCBA 708 contain basic electronic components: resistors, capacitors, crystals, etc., as required. The bottom surface of PCBA 708 may include connectors to the various sensors, the temperature measurement sensor module, the PPG measurement sensor module, the blood pressure measurement module, the battery, etc. As well, PCBs may contain connectors to program or debug the microcontrollers, solder pads for a wireless charger coil, test points to measure different signals on the PCB, power supplies for all of the electronics, and basic electronics parts such as resistors, capacitors, coils, transistors, etc. As is known in the art, the location of the electronic components, the layout of the PCBs, and the positioning of connectors, test pads, etc. may vary depending on each embodiment without departing from the scope of the technology or the teachings herein.

[0052] BPM PCB 710 may include electronic circuits to control the Blood Pressure Module. These circuits are responsible for measuring the blood pressure including initiating a measurement, collecting measurement data, and terminating the measurement. BPM PCB 710 circuits also control the inflation and deflation of the cuff 302 to the required pressure. [0053] FIG. 8 illustrates steps 800 to be performed by a user to prepare to use medical device 106, according to an embodiment. In Step 1 802, the user sits or lies down in a comfortable position and relaxes themselves in preparation of measurements being made. In Step 2 804, the user removes sufficient clothing form their left arm and torso to expose skin in areas where sensors of medical device 106 are to make contact. Note that Step 1 802 and Step 2 804 may be reversed in order. In Step 3 808 the cuff 302 is tightened slightly above the left arm of the user with approximately one finger width between the cuff and the user’s arm. The cuff allows for blood pressure measurements to be performed and places bio-impedance sensor 406, and the LA ECG sensor 404 in contact with the skin of the user’s left arm. In Step 4 810, the flap 306 is unrolled and placed on the lower part of the user’s breast, in-line with the user’s heart. Flap 306 is placed so that ECG sensors VI through V5 make contact with the user’s skin and are correctly positioned on the user to ensure accurate ECG measurements. In Step 5 812 the user (or someone helping the user) may press down on the flap 306 with their right hand and place the middle finger of their right hand over sensor module 318 which includes PPG sensor 324, RA ECG sensor 322, and bio impedance sensor 320. Sensor module 318 may include a U-shaped portion formed at the extremity of sensor module 318 towards interface module 304 to aid a user in correctly placing and maintaining their finger in place during measurements. In Step 6 814 the user (or someone helping the user) ensures that the cuff 302 is pressed against their torso. Pressing cuff 302 against the user’s torso ensures that the sensor module 314 including V6 ECG sensor 410, the RL ECG sensor 408, and the LL ECG sensor 316 make proper contact with the skin on the left side of the user’s torso to ensure accurate measurements from these sensors. In Step 7 816 the user remains in a relaxed position and avoids moving or speaking while measurements begin and until the measurements have been completed.

[0054] FIG. 9 illustrates the timing of measurements performed by medical device 106, according to an embodiment. The measurement period may be divided into three main phases. Phase 1 - T1 901 is used by the user to get comfortable and relax, as well as for the blood pressure (BP) circuitry to power on and enter a state to begin BP measurements. T1 lasts for approximately 15s and may be extended. Phase 2 - T2902 is when all measurements other than ECG are performed. These measurements include blood pressure (BP), heart rate (HR), body temperature (T°), fat mass index (FMI), respiratory rate (RR), and blood oxygen saturation (SpCh). T2 lasts approximately 45s. The final phase is Phase 3 - T3 903 and is when a 12-lead ECG measurement is taken. T3 903 last approximately 30s. The entire measurement cycle therefore takes approximately 90s. The temperature measurement can take place any time over the 90s measurement cycle. Though it is desirable that all measurements be completed in less than 2 minutes, the time required for a user to get settled and the time required for measured and calculated health parameters to be transferred over a network to remote storage may vary and prolong the process.

[0055] FIG. 10 presents an illustration of the placement of medical device 106 when used by a user, according to an embodiment. The cuff 302 of medical device 106 is placed around a user’s left arm above the elbow to allow for BPM and the other health parameter measurements as described herein. Interface module 304 faces towards the front of the user to allow for easy operation. Flap 306 is extended to allow for ECG sensors VI through V5 to contact the user’s chest. The user’s right arm is used to hold flap 306 in place with the middle finger of the user’s right arm on sensor module 318. The user holds their left arm against the left side of their torso to ensure that sensor module 314 and temperature sensor 312 makes adequate contact with their skin.

[0056] It will be appreciated that, although specific embodiments of the technology have been described herein for purposes of illustration, various modifications may be made without departing from the scope of the technology. The specification and drawings are, accordingly, to be regarded simply as an illustration of the invention as defined by the appended claims, and are contemplated to cover any and all modifications, variations, combinations or equivalents that fall within the scope of the present invention. In particular, it is within the scope of the technology to include a computer program product or program element, or a program storage or memory device such as a magnetic or optical wire, tape or disc, or the like, for storing signals readable by a machine, for controlling the operation of a computer according to the method of the technology and/or to structure some or all of its components in accordance with the system of the technology.

[0057] Although the present invention has been described with reference to specific features and embodiments thereof, it is evident that various modifications and combinations can be made thereto without departing from the invention. The specification and drawings are, accordingly, to be regarded simply as an illustration of the invention as defined by the appended claims, and are contemplated to cover any and all modifications, variations, combinations, or equivalents that fall within the scope of the present invention.

Claims

WHAT IS CLAIMED IS:

1. A medical device comprising: a cuff configured to receive a user’s left arm; an interface module coupled to the cuff, the interface module including a user interface; and a flap coupled to the cuff and the interface module, the flap configured to make contact with the user’s chest, the cuff and the flap including a plurality of sensors, the plurality of sensors including 12-lead electrocardiogram (ECG) sensors.

2. The medical device of claim 1 , wherein the interface module includes a communications module configured to communicate over a wireless network.

3. The medical device of claim 1, wherein the communications module is configured to communicate with a mobile device and a remote server.

4. The medical device of claim 3, wherein the remote server is a cloud computing service.

5. The medical device of claim 1, wherein the plurality of sensors includes a body temperature sensor, a blood pressure sensor, a 4-wire bio-impedance sensor, and a blood oxygen saturation sensor.

6. The medical device of claim 1, wherein the flap contains VI through V5 ECG sensors and the cuff contains a V6 ECG sensor, the cuff and the flap configured to position the VI through V6 ECG sensors on the user’s skin to receive ECG measurements when worn by the user.

7. The medical device of claim 1, wherein the cuff contains an LA ECG sensor on an internal surface of the cuff, the cuff configured to place the LA ECG sensor on the user’s skin to receive ECG measurements.

8. The medical device of claim 1, wherein the cuff contains an infrared body temperature sensor on an internal surface of the cuff, the cuff configured to place the infrared body temperature sensor on the user’s skin to receive temperature measurements.

9. A method for monitoring a user using a medical device, the method comprising: inserting the user’s left arm into a cuff of the medical device and tightening the cuff above the user’s left elbow, an internal surface of the cuff making contact with skin of the user, an external surface of the cuff making contact with skin of the user’s torso; unrolling a flap of the medical device, the unrolled flap making contact with skin of a lower part of the user’s breast in-line with the user’s heart; placing the user’s right palm against the flap and placing the user’s right middle finger over a sensor on an external surface of the flap; placing the user’s left palm on a lower right portion of the user’s abdomen; and initiating the monitoring.

10. The method of claim 9 wherein monitoring includes the measurement of health parameters of the user including a blood pressure, a heart rate, a body temperature, a respiratory rate, a body fat-mass index, a blood oxygen saturation, and a 12-leads ECG.