1. Field of the Invention
The present invention relates to medical devices for monitoring information, such as heart rate and calories burned, from a subject.
2. Description of the Related Art
Pedometers are common devices that typically include a motion-sensitive component, such as an accelerometer or a tilt switch, that typically generates an analog voltage that peaks in response to motion (e.g., steps). A microcontroller can receive the analog voltage, digitize it, and then process it by counting the peaks to determine a subject's steps. Heart rate monitors are also common devices that measure a subject's heart rate, typically by measuring a biometric signal (i.e., by processing an electrical signal collected by an electrode, such as that used in an ECG) or an optical plethysmograph (i.e., by processing an optical signal collected by a pulse oximeter).
Pulse oximeters are typically worn on a patient's finger or ear lobe, and feature a processing module that analyzes data generated by an optical module. The optical module typically includes first and second light sources (e.g., light-emitting diodes, or LEDs) that transmit optical radiation at, respectively, red (λ˜630-670 nm) and infrared (λ˜800-1200nm) wavelengths. The optical module also features a photodetector that detects radiation transmitted or reflected by an underlying artery. Typically the red and infrared LEDs sequentially emit radiation that is partially absorbed by blood flowing in the artery. The photodetector is synchronized with the LEDs to detect transmitted or reflected radiation. In response, the photodetector generates a separate radiation-induced signal for each wavelength. The signal, called a plethysmograph, is an optical waveform that varies in a time-dependent manner as each heartbeat varies the volume of arterial blood, and hence the amount of transmitted or reflected radiation. A microprocessor in the pulse oximeter processes the relative absorption of red and infrared radiation to determine the oxygen saturation in the patient's blood. A number between 94%-100% is considered normal, while a value below 85% typically indicates the patient requires hospitalization.
In one aspect the invention provides a monitoring device that features: 1) a cardiac sensor component with at least one LED and a photodetector; 2) a pedometer component with at least one motion-sensing component (e.g., an accelerometer); and 3) a wireless component with a wireless interface that communicates with an external weight scale. The device also features a microprocessor in electrical communication with the cardiac sensor, pedometer, and wireless components and configured to analyze: 1) a signal from the cardiac sensor component to generate heart rate information; 2) a signal from the pedometer component to generate exercise information; 3) heart rate and exercise information to generate calorie information; and 4) a signal from the external weight scale to calculate weight information (e.g., weight and percent body fat). The monitoring device also includes a transmitting component (e.g. a serial port or wireless interface) that transmits the heart rate, exercise, calorie, and weight information to an external device, such as a personal computer connected to the Internet.
In embodiments, the microprocessor is configured to operate a computer algorithm that processes the heart rate and exercise information to generate calorie information, such as calories burned. For example, the algorithm can process the physical activity information to determine whether a subject is at rest or undergoing exercise, and once this is determined compare the heart rate information to pre-determined calibration information to determine an amount of calories burned by the subject. More specifically, the calibration information can include a predetermined data table or mathematical function that correlates oxygen consumed as a function of heart rate. The algorithm can then calculate caloric expenditure from the amount of oxygen consumed.
The invention has many advantages, particularly in providing a small-scale, low-cost device that rapidly measures health-related indicators such as blood pressure, heart rate, and blood oxygen content. In embodiments, the device makes blood pressure measurements without using a cuff in a matter of seconds, meaning patients can easily monitoring device this property with minimal discomfort. In this way the monitoring device combines all the benefits of conventional blood-pressure measuring devices without any of the obvious drawbacks (e.g., restrictive, uncomfortable cuffs). Its measurement, made with an optical ‘pad sensor’, is basically unobtrusive to the patient, and thus alleviates conditions, such as a poorly fitting cuff, that can erroneously affect a blood-pressure measurement. Ultimately this allows patients to measure their vital signs throughout the day (e.g., while at work), thereby generating a complete set of information, rather than just a single, isolated measurement. Physicians can use this information to diagnose a wide variety of conditions, particularly hypertension and its many related diseases.
The device additionally includes a simple wired or wireless interface that sends vital-sign information to a personal computer. For example, the device can include a Universal Serial Bus (USB) connector that connects to the computer's back panel. Once a measurement is made, the device stores it on an on-board memory and then sends the information through the USB port to a software program running on the computer. Alternatively, the device can include a short-range radio interface (based on, e.g., Bluetooth™ or 802.15.4) that wirelessly sends the information to a matched short-range radio within the computer. The software program running on the computer then analyzes the information to generate statistics on a patient's vital signs (e.g., average values, standard deviation, beat-to-beat variations) that are not available with conventional devices that make only isolated measurements. The computer can then send the information through a wired or wireless connection to a central computer system connected to the Internet.
The central computer system can further analyze the information, e.g. display it on an Internet-accessible website. This means medical professionals can characterize a patient's real-time vital signs during their day-to-day activities, rather than rely on an isolated measurement during a medical check-up. The website typically features one or more web pages that display the blood test, vital sign, exercise, and personal information. In embodiments, the website includes a first web interface that displays information for a single patient, and a second web interface that displays information for a group of patients. For example, a medical professional (e.g. a physician, nurse, nurse practitioner, dietician, or clinical educator) associated with a group of patients could use the second web interface to drive compliance for a disease-management program. Both web interfaces typically include multiple web pages that, in turn, feature both static and dynamic content, described in detail below.
The website can also include a messaging engine that processes real-time information collected from the device to, among other things, help a patient comply with a disease-management program, such as a personalized cardiovascular risk reduction program. The messaging engine analyses blood test, vital sign, exercise, and personal information, taken alone or combined, to generate personalized, patient-specific messages. Ultimately the Internet-based system, monitoring device, and messaging engine combine to form an interconnected, easy-to-use tool that can engage the patient in a disease-management program, encourage follow-on medical appointments, and build patient compliance. These factors, in turn, can help the patient lower their risk for certain medical conditions.
These and other advantages of the invention will be apparent from the following detailed description and from the claims.
a is a flow chart describing a first algorithm used by the monitoring devices of
b is a flow chart describing a second algorithm used by the monitoring devices of
The monitoring device can be used for a variety of applications relating to, e.g., disease management, health maintenance, and medical diagnosis.
In other embodiments, the small-scale monitoring device 5 transmits patient information using a short-range wireless transceiver 7 through a short-range wireless connection 37 (e.g., Bluetooth™, 802.15.4, part-15) to the personal computer 30. For example, the small-scale monitoring device 5 can transmit to a matched transceiver 12 within (or connected to) the personal computer 30.
During typical operation, the patient 11 uses the monitoring device 5 for a period of time ranging from a 1-3 months. Typically the patient 11 takes measurements a few times throughout the day, and then uploads the information to the Internet-based system 36 using a wired connection. Alternatively, the monitoring device 5 can measure the patient 11 continuously during periods of exercise. To view patient information sent from the monitoring device 5, the patient 11 (or other user) accesses the appropriate user interface hosted on the website 33 through the Internet 31.
In other embodiments, the monitoring device 5 connects through the mini USB port 3 and glucometer interface circuit 64 to an external glucometer to download blood-glucose levels. The monitoring device 5 also processes information from an integrated pedometer circuit 9 to measure steps and amount of calories burned, as described below.
The monitoring device 5 includes a short-range wireless transceiver 7 that sends information through an antenna 67 to a matched transceiver embedded in an external device, e.g. a personal computer. The short-range wireless transceiver 7 can also receive information, such as weight and body-fat percentage, from an external scale. A battery 51 powers all the electrical components within the small-scale monitoring device 5, and is preferably a metal hydride battery (generating 3-7V) that can be recharged through a battery-recharge interface 2. The battery-recharge interface 52 can receive power through a serial port, e.g. a computer's USB port. Buttons control functions within the monitoring device such as an on/off switch 8a and a system reset 8b.
a shows a flow chart describing an algorithm 100 used by the monitoring device of
The algorithm 100, which uses a patient's physical activity (PA) level and heart rate (HR), is based on a methodology developed by Moon and Butte (Moon J K and Butte N F; Combined heart rate and activity levels improve estimates of oxygen consumption and carbon dioxide production rates; J appl Physiol 81: 1754-1761, 1996), the contents of which are incorporated herein by reference.
As a first step 101, the algorithm 99 features a process that calibrates the monitoring device so that it can accurately measure calories burned during exercise. During the first step 101 VO2 and HR are simultaneously measured during simulated, representative ‘active’ and ‘inactive’ periods, defined below. For example, VO2 can be measured using indirect calorimetry while HR is measured using any number of techniques (e.g., ECG). VO2 is then plotted as a function of HR for both the active and inactive periods. The resultant data are then fit with either a quadratic equation (for the inactive periods) or a linear equation (for the active periods), show below, to yield calibration parameters a, b, c, d. These calibration parameters will be most accurate if they are measured from a population that is representative to patients actually using the device.
Typically the calibration process lasts a few hours and data describing VO2 and HR are collected every minute. Active and inactive periods for the calibration process typically include the following:
b shows an alternate embodiment of the algorithm 99 shown in
The branched equations are defined in more detail in the following reference, the contents of which are incorporated herein by reference: Brage S, Brage N, Franks P W, Ekelund U, Wong M, Andersen L B, Froberg K, and Wareham N J; Branched equation modeling of simultaneous accelerometry and heart rate monitoring improves estimate of directly measured physical activity energy expenditure; J appl Physiol 96: 343-351, 2004. The branched equations process values of HR and PA by comparing them with benchmark values, and in response assign percentages that define the relative contribution of these parameters to PAEE. These percentages will vary depending on the group used for the calibration process, and ultimately determine the total value for PAEE.
Kcal/min→VO2*(3.941+1.106*RQ)
In another alternative first step 126 estimates REE using the Harris-Benedict equation:
In yet another alternate first step 127, REE calculated as described above is modified using recording time (RT), i.e.:
REE′=REE*(1440 −RT)
Once REE is determined, the algorithm 120 uses a second step 128 to estimate DIT using TEE and the equation:
DIT=0.1*TEE
Alternatively, DIT is calculated by estimating the macronutrient composition of the subject's diet. This is done using the following equation for the second step 130 of the algorithm 120:
DIT=0.025*fatEl −0.07*carbohydrateEl+0.275*proteinEl
During a third step 132 the algorithm uses TEE (described above with reference to
DEE=REE+DIT+PAEE
or
DEE=REE+DIT+TEE
Methods for processing optical and electrical waveforms to determine blood pressure without using a cuff are described in the following co-pending patent applications, the entire contents of which are incorporated by reference: 1) CUFFLESS BLOOD-PRESSURE MONITORING DEVICE AND ACCOMPANYING WIRELESS, INTERNET-BASED SYSTEM (U.S. Ser. No 10/709,015; filed Apr. 7, 2004); 2) CUFFLESS SYSTEM FOR MEASURING BLOOD PRESSURE (U.S. Ser. No. 10/709,014; filed Apr. 7, 2004); 3) CUFFLESS BLOOD PRESSURE MONITORING DEVICE AND ACCOMPANYING WEB SERVICES INTERFACE (U.S. Ser. No. 10/810,237; filed Mar. 26, 2004); 4) VITAL-SIGN MONITORING DEVICE FOR ATHLETIC APPLICATIONS (U.S. Ser. No.; filed Sep. 13, 2004); 5) CUFFLESS BLOOD PRESSURE MONITORING DEVICE AND ACCOMPANYING WIRELESS MOBILE DEVICE (U.S. Ser. No. 10/967,511; filed Oct. 18, 2004); and 6) BLOOD PRESSURE MONITORING DEVICEING DEVICE FEATURING A CALIBRATION-BASED ANALYSIS (U.S. Ser. No. 10/967,610; filed Oct. 18, 2004); 7) PERSONAL COMPUTER-BASED VITAL SIGN MONITORING DEVICE (U.S. Ser. No. 10/906,342; filed Feb. 15, 2005); and 8) PATCH SENSOR FOR MEASURING BLOOD PRESSURE WITHOUT A CUFF (U.S. Ser. No. 10/906,315; filed Feb. 14, 2005).
Still other embodiments are within the scope of the following claims.
This application claims the benefit of U.S. Provisional Application Ser. No. 60/721,665 filed on Sep. 29, 2005 and is hereby incorporated by reference.
Number | Date | Country | |
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60721665 | Sep 2005 | US |