WO2007040478A1

WO2007040478A1 - System and methods of monitoring vital signs of a living subject

Info

Publication number: WO2007040478A1
Application number: PCT/US2005/033787
Authority: WO
Inventors: Tarun Surti
Original assignee: Bio-Products, Inc.
Priority date: 2005-09-23
Filing date: 2005-09-23
Publication date: 2007-04-12

Abstract

A system (10) for monitoring vital signs of a living subject over an extended period of time. In one embodiment, the system (10) includes a monitoring device (100) having an ASIC chip (110), the ASIC chip (110) including a sensor (111) and a processor (112), the sensor (111) adapted for collecting a vital sign from an adjacent area of skin of the living subject when activated, the processor (112) in communication with the sensor (111) and adapted for converting the vital sign into data having electronically transmittable format, the monitoring device (100) further including a communication device for receiving the data and transmitting the data wirelessly, and a receiving device (200), adapted to receive the wireless transmission of data from the monitoring device (100) and adapted further to process the data.

Description

SYSTEM AND METHODS OF MONITORING VITAL SIGNS OF A LIVING SUBJECT

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of and priority to U.S. Provisional Patent Application No. 60/613,015, filed September 23, 2004, entitled "SYSTEM AND METHODS OF MONITORING LIFE SIGN OF A LIVING SUBJECT" by Tarun SURTI, which is incorporated herein by reference in its entirety.

FIELD OF THE PRESENT INVENTION

The present invention generally relates to vital sign monitoring, and more particularly, to methods and systems for monitoring vital signs of a living subject.

BACKGROUND OF THE INVENTION

Vital signs are physical signs that indicate an individual is alive, such as heart beat, breathing rate, body temperature, and blood pressure. Other vital signs are indicative of the well-being of the individual, such as blood sugar, ECG, EKG, and brainwaves. These signs may be observed, measured, and monitored to assess an individual's level of physical functioning. Normal vital signs vary depending on age, gender, body weight, exercise tolerance, and other conditions.

Normal ranges of the key vital signs for an average healthy person are:

• Body temperature: Body temperature is an important life sign of living subjects including human beings and animals. The normal core body temperature of a healthy, resting adult human being is usually referred to as an oral temperature of 98.6 °F degrees Fahrenheit or 37.0 ⁰C degrees Celsius. Though the body temperature measured on an individual can vary, a healthy human body can maintain a fairly consistent body temperature that is around the mark of 98.6 °F ± 1 °F Fahrenheit or 37.0 ⁰C ± 0.6 ⁰C degrees Celsius throughout the day, depending on a person's activity level, the time of day, and other variables, including, for instance, whether a woman is ovulating or having her menstrual period.

• Breathing:

Breathing rate is measured by counting for full minute with a subject least distressed and without the subject aware of the measurement. The normal ranges of breathing rate are from 44 breaths per minutes for a newborn to 14 to 18 breaths per minute for a healthy adult.

• Pulse Rate:

Pulse rate is the number of times a person's heart beats in one minute. It is done by putting slight pressure on any artery in which pulsations are felt on the wrist. Normal values for pulse rate depend on the person's age and fitness level. The normal ranges of pulse rate are from 130 - 140 heartbeats per minutes for a newborn to 70 - 75 heartbeats per minute for a healthy adult.

• Blood Pressure: Blood pressure is the force of blood pushing against blood vessel walls. The heart pumps blood into the arteries (blood vessels), which carry the blood throughout the body. High blood pressure, also called hypertension, is dangerous because it makes the heart work harder to pump blood to the body and it contributes to hardening of the arteries or atherosclerosis. The blood pressure is measured in mm of mercury (mm Hg). Normal blood pressure for an healthy adult is not more than 120 (systolic) / 80 (diastolic).

• Other categories of blood pressure include: o Prehypertension: 120-139 (systolic)/ 80-89 (diastolic). o Stage 1 hypertension: 140-159 (systolic)/ 90-99 (diastolic). o Stage 2 hypertension: ≥i 60 (systolic)/ ≥i 00 (diastolic).

Vital signs beyond these listed normal ranges are usually an indication of abnormality. For example, an elevated body temperature (fever) is usually a common and normal reaction to viral and/or bacterial infections, medications such as antibiotics, narcotics, barbiturates, antihistamines, and many others, severe trauma or injury, such as a heart attack, stroke, heat exhaustion, heatstroke, or burns and other medical conditions, such as arthritis, hyperthyroidism, and even some cancers. On the other hand, an abnormally low body temperature (hypothermia) can be serious, even life-threatening. Low body temperature may occur from cold exposure, shock, alcohol or drug use, or certain metabolic disorders, such as diabetes or hypothyroidism. In addition, a low body temperature may also occur in certain infections, particularly in newborns, older adults, or people who are frail.

The fluctuation of other vital signs such as blood pressure or breathing rate may also be an indication of certain diseases or illness. If someone's blood pressure is beyond the normal ranges of less than 120 / 80 mm of Hg, then it means the person may suffer hypertension. The hypertension may be caused by many diseases such as narrowing of the arteries, a greater than normal volume of blood, or the heart beating faster or more forcefully than it should. If someone's breathing rate is outside of the normal range, this person may suffer tachypnea or bradypnea. These symptoms may further reveal the root cause of certain diseases or illness such as acute respiratory distress, congestive heart failure, anemia, hyperthyroidism or pneumonia for tachypnea and uremia, increased intracranial pressure, excessive sedation with alcohol, or benzodiazepines, illicit drug use such as morphine for bradypnea. Vital sign monitoring, especially over an extended period, is an important means for discovering any abnormalities of a patient either in a hospital or at home. Early detection of changes in patient's vital signs such as body temperature, blood pressure, breathing rate, and pulse rate allow a medical professional to adjust the patient's medication, treatment or diet before the symptoms reach a critical level. Therefore, vital sign monitoring is very important means for ensuring the well-being of human and/or animals.

For simplicity and to illustrate the benefit of the present invention, the following examples are focused only on one of the vital signs: the body temperature. Traditionally, human body temperature is measured by placing a thermometer or a temperature sensing device into a body cavity such as mouth, rectum, ear, or arm pit. Such measurement methods are considered either inconvenient or invasive by many people especially when frequent measurements are performed to track body temperature trend over an extended period of time. Monitoring a febrile infant at night and at home is a difficult task for parents, especially if the fever spans several days. First, taking the "core" temperature (oral, rectal, or even aural) of a sleeping and febrile infant is a rather difficult task. Second, lack of cooperation from a very small infant will increase level of difficulty for the parents. Therefore, the disadvantages of the conventional temperature measurement and monitoring device are summarized as following: (1) it is difficult to monitor over an extended period of time; (2) it is difficult to monitor temperature frequently; (3) it is invasive, inconvenient and uncomfortable; (4) the measurement require cooperation from patients, and it is very difficult for very small infants; and (5) it is almost impossible to measure or monitor body temperature of live animals with such temperature measuring devices.

Therefore, there is a need to develop an inexpensive, flexible, easy to use, reliable, disposable, "peel and stick" wireless body temperature monitoring device.

Among earlier work in the field of temperature monitoring, telesensors whose data is retrieved remotely have been introduced. The basic components of the wireless temperature sensor system are a sensing device and a data-recording device. In U.S. Pat. No. 4,387,724, Zartman describes a device for remotely detecting and monitoring patient's temperature on a long term basis. It is a deep body temperature monitoring device used for a female mammalian animal for ovulation and husbandry monitoring. The device utilizes an anchored intra-vaginal sensor array. While providing a more accurate measurement of deep body temperature, such a device is not tolerated by the general human population. U. S. Pat. No. 5,050,612 by Matsumura describes a computer-assisted device for monitoring ovulation cycles in humans, which also involves an intra-vaginal sensor.

Methods of using skin temperature in a protected region of the body to monitor body temperature are a surrogate measurement that is considered less invasive and, therefore, well tolerated. The basic components of a wireless skin temperature sensor system are a skin temperature sensing device and a data-recording device. The skin temperature sensing device is designed to measure skin temperature, convert the value to core body temperature, and provide the results to the data recording device. With significant technological advancement, methods for sensing body temperature through skin have emerged and are becoming more widely accepted. In U.S. Pat. No. 5,844,862, Cocatre-Zilgien describes a temperature monitoring system reading skin temperature that places the data receiver in a bedside device. The system has only limited applications such as for nighttime use, or for monitoring a bed-ridden patient, because the temperature-sensing component of the system is not attached to skin. The system is also intended to transmit temperature data to a professional caregiver and is not focused upon use by the patient, family member, or non-professional caregiver.

Some other systems exist on the market today with improved performance features such as using a skin patch. These systems, however, are designed to be used in regulated environments, such as hospitals. Wireless temperature sensor systems with temperature sensing and tracking capability for average consumers are not currently available. In addition to body temperature, other vital signs have similar difficulties and a comprehensive monitoring system which is able to monitor more than one vital signs of the living subject is yet to be discovered.

Therefore, a heretofore unaddressed need exists in the art to address the aforementioned deficiencies and inadequacies.

SUMMARY OF THE INVENTION

The present invention relates to vital sign monitoring, more particularly, to methods and systems for monitoring vital signs of a living subject. In one aspect, the present invention relates to a system for monitoring vital signs of a living subject. In one embodiment, the system comprises a monitoring device having an application specific integrated circuit (hereinafter "ASIC") chip, the ASIC chip including a sensor and a processor, the sensor adapted for collecting a vital sign from an adjacent area of skin of the living subject when activated, the processor in communication with the sensor and adapted for converting the vital sign into data in electronically transmittable format, the monitoring device further including a communication device for receiving the data and transmitting the data wirelessly, and a receiving device, adapted for receiving the wireless transmission of data from the monitoring device and processing the data. In another embodiment, the data includes at least one of sample serial number, frequency at which the monitoring device collects the vital sign, monitoring device identification number, type of the vital sign and vital sign value.

In one embodiment, the monitoring device further comprises a protective sheet placed between a surface of the ASIC chip and the area of skin, hi another embodiment, the protective sheet is thermally conductive and includes thermally conductive gel placed thereupon, hi yet another embodiment, the processor comprises a Field Programmable Gate Array (hereinafter "FPGA"). hi a futher embodiment, the processor comprises a Complex Programmable Logic Device (hereinafter "CPLD"). hi an additional embodiment, the ASIC chip is preferably pre- calibrated for consistency and accurate vital sign readings. hi one embodiment, the communication device includes a transmitter and oneway communication is established from the monitoring device to the receiving device. In another embodiment, the communication device includes a transceiver and the monitoring device is capable of two-way communication, hi one embodiment, the monitoring device further comprises a printed circuit board (PCB). In another embodiment, the monitoring device is attached to the area of the skin of the living subject with a bandage or adhesive covering, hi an additional embodiment, the monitoring device further comprises an antenna in communication with the ASIC chip, hi one embodiment, the antenna is woven into the bandage used to fasten the monitoring device to the area of skin of the living subject, hi another embodiment, the antenna is formed on the surface of the PCB and connects to the ASIC chip, hi yet another embodiment, the communication device is part of the ASIC chip, hi a further embodiment, the monitoring device further comprises a thermally non- conductive insulating pad adapted for insulating the sensor from the environment surrounding the area of skin.

In one embodiment, the vital sign is indicative of a physical state of the living subject. In another embodiment, the physical state of the living subject relates to body temperature, the blood, the heart, an organ, a status of the circulatory system, a status of the respiratory system, a status of the blood sugar level, a status of the brain activity, or the status of the well-being of the living subject. In one embodiment, the receiving device comprises an antenna adapted for receiving the data transmitted from the monitoring device, a controller adapted for controlling operation of the receiving device, a display adapted for displaying information corresponding to the vital sign of the living subject, and an alarm in communication with the controller, and adapted for generating an alert when a threshold related to the vital sign of the living subject is reached. In another embodiment, the antenna of the receiving device is further adapted for transmitting data and commands to the monitoring device, hi yet another embodiment, the receiving device further comprises a USB port in communication with the controller and adapted for uploading the data related to the vital sign of the living subj ect to an external device for further data display or archiving.

In another aspect, the present invention relates to a method for monitoring vital signs of a living subject over an extended period of time. In one embodiment, the method comprises the steps of attaching a monitoring device to a predetermined area of skin of the living subj ect, activating the monitoring device, using the monitoring device to collect the vital sign of the living subject, to convert the vital sign into data in electronically transmittable format, and to transmit the data wirelessly to a remote receiving device, receiving the data at the remote receiving device, and processing the data for further use. In one embodiment, the step of attaching the monitoring device further comprises placing a protective sheet between a surface of the monitoring device and the predetermined area of skin. In another embodiment, the step of attaching the monitoring device further comprises attaching the monitoring device to the living subject with a bandage or adhesive covering. In yet another embodiment, the step of attaching the monitoring device further comprises the step of attaching the monitoring device adjacent the predetermined area of skin using a thermally conductive adhesive.- hi a further embodiment, the method further comprises the step of insulating the monitoring device from the environment surrounding the predetermined area of skin. In one embodiment, activating the receiving device prior to the step of activating the monitoring device is preferred. In another embodiment, the step of activating the monitoring device further comprises sending commands from the receiving device. In one embodiment, the step of collecting the vital sign of the living subject further comprises using a sensor in the monitoring device to obtain information related to a physical state of the living subject. In another embodiment, the step of collecting the vital sign of the living subject further comprises using a plurality of sensors in the monitoring device to obtain information related to physical states of the living subject.

Li one embodiment, the step of processing the data for further use comprises displaying the vital sign of the living subject according to the received data, hi another embodiment, the step of processing the data for further use comprises uploading the data into an external device, hi yet another embodiment, the step of processing the data for further use comprises generating an alarm when a threshold related to the vital sign of the living subject is reached.

In yet another aspect, the present invention relates to an apparatus for monitoring vital signs of a living subject. In one embodiment, the apparatus comprises an ASIC chip comprising a sensor adapted for placement adjacent a predetermined area of skin of the living subject, and when activated, for collecting a vital sign from the predetermined area of skin, and a processor in communication with the sensor, wherein the processor converts the vital sign obtained by the sensor into data in electronically transmittable format, and a communication device in communication with the processor and adapted for communicating the data wirelessly to a remote receiving device, hi another embodiment, the electronically transmittable data includes at least one of sample serial number, frequency at which the monitoring device collects the vital sign, monitoring device identification number, type of the vital sign and vital sign value. hi one embodiment, the apparatus is attached to the predetermined area of skin of the living subject with a bandage or adhesive covering, hi another embodiment, the apparatus further comprises a protective sheet placed between a surface of the ASIC chip and the predetermined area of skin. The protective sheet is preferably thermally conductive and includes a layer of thermally conductive gel placed adjacent the predetermined area of skin, hi yet another embodiment, the apparatus further comprises a thermally non-conductive insolating pad adapted for insulating the sensor from the environment surrounding the predetermined area of skin.

In one embodiment, the apparatus further comprises a PCB. In another embodiment, the processor comprises an FPGA or a CPLD. In one embodiment, the communication device includes a transmitter, and one-way communication is established from the apparatus to the receiving device. In another embodiment, the communication device includes a transceiver, and the apparatus is capable of two-way communication. In an additional embodiment, the ASIC chip is preferably pre- calibrated for consistency and accurate vital sign readings. In one embodiment, the monitoring device further comprises an antenna in communication with the ASIC chip. In another embodiment, the antenna is woven into a bandage used to fasten the apparatus to the predetermined area of skin of the living subject. In yet another embodiment, the antenna is formed on the surface of the PCB and connects to the ASIC chip. In a further embodiment, the communication device is part of the ASIC chip.

In one embodiment, the vital sign of a living subject relates to a signal associated with the state of the living subject, hi another embodiment, the physical state of the living subject relates to body temperature, the blood, the heart, an organ, a status of the circulatory system, a status of the respiratory system, a status of the blood sugar level, a status of the brain activity, or the status of the well-being of the living subject.

These and other aspects of the present invention will become apparent from the following description of the preferred embodiment taken in conjunction with the following drawings, although variations and modifications therein may be affected without departing from the spirit and scope of the novel concepts of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a system overview of a two component monitoring system for monitoring vital sign of a living subject according to one embodiment of the present invention. FIGS. 2 A and 2B schematically show a monitoring device for monitoring vital signs of a living subject according to one embodiment of the present invention. FIG. 2A is a cross-section view of the monitoring device. FIG. 2B is a partial bottom- view of the monitoring device with some of components removed.

FIG. 3 illustrates two block diagrams of the monitoring device for monitoring vital signs of a living subject according to one embodiment of the present invention. FIG. 3 A is a monitoring device with a separate communication device in addition to an ASIC chip. FIG. 3B is a monitoring device with a built-in communication device inside the ASIC chip.

FIGS. 4 A and 4B show the detailed block diagram of two embodiments in accordance with the present invention, hi FIG. 4A, the ASIC chip does not include the communication device. In FIG. 4B, the communication device is integrated as a part of the ASIC chip.

FIG. 5 is a flow chart of the operation of the monitoring device for monitoring vital sign of the living subject according to one embodiment of the present invention.

FIG. 6 illustrates an exemplary vital sign data packet according to one embodiment of the present invention.

FIG. 7 is a block diagram of a receiving device for monitoring vital sign of the living subject according to one embodiment of the present invention.

FIG. 8 is a flow chart of the operation of the receiving device for monitoring vital sign of the living subject according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is more particularly described in the following examples that are intended as illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. Various embodiments of the invention are now described in detail. Referring to the drawings, like numbers indicate like parts throughout the views. As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein and throughout the claims that follow, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. The description will be made as to the embodiments of the present invention in conjunction with the accompanying drawings FIG. 1 - FIG. 8. In accordance with the purposes of this invention, as embodied and broadly described herein, this invention, in one aspect, relates to a system 10 for wirelessly monitoring vital signs of a living subject.

Referring now to FIG. 1, the system 10 for monitoring vital sign of a living subject is shown. The system comprises: a vital sign monitoring device (hereinafter "monitoring device") 100 and a receiving device 200. As described in greater detail hereinafter, the monitoring device 100 includes a power source, an ASIC chip, and an antenna. The vital sign of the living subject is detected by the monitoring device, converted into data in electronically transmittable format, and transmitted through the antenna in radio frequency (hereinafter "RF") to the receiving device 200. The living subject is either a human being or an animal. The vital sign of the living subject relates to a signal associated with the state of the living subject. The signal associated with the state of the living subject relates to body temperature, the blood, the heart, an organ, the body, a status of the circulatory system, a status of the respiratory system, a status of the blood sugar level, a status of the brain activity, or the status of the well- being of the living subject.

FIG. 1 shows only the configuration of one monitoring device 100 and one receiving device 200. Many other configurations of the vital sign monitoring system are also possible. In one embodiment, for example, multiple monitoring devices 100 working concurrently in the receiving area of one receiving device 200 can be put into practice. In another embodiment, one monitoring device 100 with multiple sensors for different types of vital sign can be implemented.

FIGS. 2 A and 2B show schematic drawings of an exemplary monitoring device 100 according to one embodiment of the present invention. FIG. 2 A is a cross- section view of the monitoring device 100. The monitoring device 100 comprises a printed circuit board (hereinafter "PCB") 108 having a first surface 108a and an opposite, second surface 108b, an ASIC chip 110 having a first surface 110a and an opposite, second surface 110b with its second surface 110b mounted on the first surface 108a of the PCB 108, a thin profile battery 102 adapted for providing power to the ASIC chip 110 and the PCB 108 assembly, and a thermal non-conductive insulating pad 104 having a first surface 104a and an opposite, second surface 104b mounted between the battery 102 and the PCB 108, and adapted for insulating the ASIC chip 110 from its surroundings to ensure vital sign measurement accuracy. FIG. 2B is a partial bottom- view of the monitoring device 100 with its thermally conductive sheet, thermally conductive adhesives and bandage removed. In one embodiment, the ASIC chip is preferably pre-calibrated for consistency and accurate vital sign readings.

The monitoring device 100 is attached to a predetermined area of skin of a living subject. In one embodiment, the monitoring device 100 is attached with thermally conductive adhesive (not shown). In another embodiment, the monitoring device 100 is fastened to skin of the living subject with one or more bandages or a patch 106 having a first surface 106a and an opposite, second surface 106b with a small pouch holding the monitoring device 100 and the first surface 106a covered with adhesive to ensure the monitoring device is securely fastened. The monitoring device 100 is preferably designed to monitor the vital signs of the living subject over an extended period of time. Therefore, the bandages or the patch 106 is preferably strong to remain adhered to the living subject over the extended period of time and during normal physical activities.

Referring now to FIGS. 3 A and 3B, two different embodiments of the monitoring device in accordance with the present invention are illustrated. In one embodiment, the ASIC chip 110 includes a sensor 111 adapted for collecting the vital sign of the living subject, a processor 112 adapted for controlling the sensor 111 and converting the collected vital sign from the sensor to data in electronically transmittable format. The data is further communicated to a communication device 103 that communicates the data to a remote receiving wirelessly. hi another embodiment, the ASIC chip 110 includes a sensor 111, a processor 112, and a built-in communication device 113 that communicates the data to the remote receiving device wirelessly. Optionally, the data can be transmitted in analog. Due to the wavelengths of usable frequencies, the size of an effective antenna may not be able to fit into or onto the ASIC chip 110; therefore, an external antenna 101 is preferably needed to effectively transmit the data to the remote receiving device (not shown in FIGS. 3 A and 3B). In one embodiment, the antenna 101 is formed on the surface of a PCB 108 (of FIGS. 2 A and 2B). In another embodiment, the antenna 101 is woven into a bandage 106 (shown in FIG. 2A). In one embodiment, the sensor 111 is used to collect at least one type of vital sign of the living subject. In another embodiment, the sensor 111 is capable of collecting more than one type of vital signs of the living subject. The monitoring device 100 is preferably configured to detect one or more of body temperature, blood pressure, pulse, blood sugar, breathing rate, ECG, EKG, or brainwaves of the living subject.

Referring now to FIGS. 4A and 4B, further details for the two embodiments disclosed in FIGS. 3A and 3B, respectively, are shown, hi FIG. 4A, the embodiment comprises an ASIC chipl 10, a separate communication device 103, and an antenna 101. The ASIC chip 110 further comprises a vital sign sensor 111, an analog to digital (hereinafter "AfD") converter 11201, a packet assembly 11203, a system clock 11205, a serial interface 11207, a controller 11209, TD fuses 11211, and a data input 11213. When the ASIC chip 110 is in operation, the power is connected to the ASIC chip 110 and the system clock 11205 is provided to the controller 11209. The vital sign sensor 111 detects the vital sign of the living subject. The detected vital sign is sent to the A/D converter 11201 to be converted to data in electronically transmittable format. Optionally, the data is transmitted to a receiving device in an analog format and the A/D converter 11201 can be eliminated. The output of the A/D converter 11201 is then sent to packet assembly 11203 to form data packet. The data packets from the packet assembly 11203 are communicated to the communication device 103 and then transmitted to a receiving device through the antenna 101. The system clock 11205 keeps all digital components of the ASIC chip 110, such as the controller 11209, the A/D converter 11201, and the packet assembly 11203 synchronized. The system clock is also a part of the output of the ASIC chip 110 to the communication device 103 to keep the communication device 103 synchronized. The controller 11209 oversees the overall operation of the ASIC chip 110. The serial interface 11207 provides an interface for the controller 11209 to receive information serially. The ID fuses 11211 provide the ASIC chip 110 a unique identification. The data input 11213 provides another data input channel to the controller 11209, as needed. The functions of the controller 11209 include activating the vital sign sensor 111, reading the vital sign results at a predetermined interval, converting the vital sign into data in electronically transmittable format, and coordinating the transmission of the vital sign to the receiving device 200. After a vital sign of the living subject has been recorded, the vital sign is converted into data in electronically transmittable format, placed into a data packet, and sent to the communication device for transmission to the receiving device. Preferably, the controller 11209 comprises a CPLD or an FPGA. The communication between the monitoring device 100 and the receiving device 200 can be either one-way from the monitoring device 100 to the receiving device 200 or two-way between the monitoring device 100 and the receiving device 200. If only one-way communication is preferred, the communication device 103 or 113 need only be a transmitter. Otherwise, the communication device 103 or 113 is preferably a transceiver.

FIG. 4A is similar to FIG. 4B. The difference between FIG. 4A and FIG. 4B is that the ASIC chip 110 in FIG. 4B includes the communication device 113 therein or thereupon.

In both FIG. 4A and FIG. 4B, the serial interface 11207, the ID fuses 11211 and the data input 11213 are optional. In one embodiment, one or more of the these interfaces such as the serial interface 11207, the ID fuses 11211 and the data input 11213 can be eliminated to further reduce the cost of the ASIC chip 110.

The communication device 103 operates preferably in the ISM (Industrial, Scientific and Medical) or SRD (Short Range Device) frequency bands (402, 426, 429, 433, 868, or 915 MHz). The selection of the RF transmission frequencies is based on the design of the antenna 101 for efficient transmission. The transmission range is preferably no less than 3 meters. With such a transmission range, the communication device 103 requires very few external components, low power consumption in active mode and very low power consumption in standby mode. The communication device 103 or 113 has a very small footprint package, and is low in cost. Optionally this communication device subsystem may be integrated directly into the ASIC chip 110 as an integral part 113, as shown in FIG. 4B. Referring now to FIG. 5, a flow chart 500 of the operation of the monitoring device for monitoring vital sign of a living subject is shown according to one embodiment of the present invention. At the start (step 503), the monitoring device is connected to a power source for supplying power to sustain the length of the monitoring period. This initialization phase 503 may include some or all of following additional steps: the monitoring device exits the reset state, the controller, its registers and memories are initialized, the ASIC chip is initialized for transmission, the ASIC chip is placed in standby mode, the vital sign sensor is initialized for transmission, and the sensor is placed in standby mode. After the monitoring device is initialized, the monitoring device attempts to establish communication with the receiving device (step 505). This step 505 preferably includes an initial delay (e.g. 30-second delay), assembling a "hello" data packet by the packet assembly of the ASIC chip, waking the ASIC chip for transmission, a series of three transmissions of "hello" data packets with a five-second delay in between "hello" data packet transmissions, and putting the ASIC chip in standby mode (step 507). Such repetition is for one-way communication between the monitoring device and the receiving device. Optionally, for a system with two-way communication between the monitoring device and the receiving device, the "hello" data packets transmissions are no longer necessary when the monitoring device receives acknowledgment from the receiving device.

Once communication between the monitoring device and the receiving device is established, the monitoring device is ready for vital sign monitoring. The vital sign monitoring is carried out in predetermined intervals (e.g. every minute, or every five minutes). This interval is preferably programmed into the controller during the initialization step 503. The phase of the measurement of the vital sign of the living subject starts (step 520). The controller checks the timer regularly to see if the measurement interval is reached (step 509). If the answer is no, the controller goes back to standby mode and wait until next time interval check. When the vital sign measurement interval is reached, the measurement of the vital sign of the living subject starts as the controller and the vital sign sensor are woken up, and the vital sign value is read. Once the vital sign value is obtained, the vital sign sensor is then placed in standby mode. The vital sign data is sent to the A/D converter to be converted into data in electronically transmittable format, and used to construct vital sign data packet by packet assembly. Then the ASIC chip is woken up and vital sign data packet is transmitted through an antenna to the receiving device (step 513). After the transmission, the ASIC chip and the controller are placed in standby mode. This concludes a vital sign measurement cycle (step 520). This measurement cycle is repeated until the battery runs out or the operator interrupts the measurement. The above disclosed process is only based on one embodiment of the present invention. Other alterations are possible to practice the present invention for those skilled in the art. Certain steps can be added and some of the steps disclosed above can be eliminated without departing from the principle of the present invention.

Referring now to FIG. 6, an exemplary detailed data packet 600 is illustrated according to one embodiment of the present invention. The data packet 600 comprises a 13-byte preamble 610, a 2-byte start of the frame 620, a 15-byte packet payload 630 and a 2-byte checksum. The packet payload 630 comprises a one-byte packet size, a three-byte sample serial number, a one-byte sampling interval, a one- byte type of the vital sign, a 7-byte monitoring device ID, and a two-byte vital sign value. Only one implementation of the present invention is presented in FIG. 6. The packet size of the payload indicates the size of the data packet. The sample number gives the receiving device the sequence of the vital sign of the living subject. The type of vital sign portion of the data packet is optional and it is used preferably for the monitoring device equipped with multiple types of vital sign sensor. It is important for the receiving device to distinguish the received data packet and process the data packet accordingly. The monitoring device ID portion is also optional and preferred for the system configuration with multiple monitoring devices working concurrently in receiving range of one receiving device. If the vital sign monitoring system does not include multiple sensor types or multiple monitoring devices, the data packet can be further simplified. Therefore, other data packet configurations are also possible to practice the present invention. Referring now to FIG. 7, a block diagram of a receiving device 200 is shown according to one embodiment of the present invention. The receiving device 200 comprises an antenna 202 adapted for receiving RF transmission from a monitoring device, a RF receiver 204 adapted for processing the RF transmission, a controller 206 adapted for storing the data and controlling the operation of the receiving device 200, a LCD display 208 adapted for displaying information related to the vital sign of the living subject and operation of the receiving device, an audible alarm 210 adapted for giving alert when attention is needed, an external control 212 adapted for providing external control by a user, and a USB post 214 adapted for uploading information to external devices. The LCD display 208 is also used to indicate the status of the unit, and to present current vital sign data, as well as historical vital sign data to the user. Optional component such as IEEE 802.1 VoIg interface can be built in for providing wireless access to the receiving device by any external devices capable of WiFi operation if such access is desired.

The controller 206 may send out audible alarm if received vital sign exceeds a preset threshold, if the receiving device 200 is so configured. In one embodiment, a small piezo electric 'buzzer' type alarm is used to alert the operator that attention is needed. In another embodiment, a flashing LED is used to indicate that an alarm is activated. hi one embodiment, the external control 212 comprises two control switches on the receiving device 200 to control the mode of operation of the receiving device 200. The switches are momentary push button types with conducting dots on the bottom. The switches sit on a PCB and protrude through openings in the case. The power source to the receiving device 200 can be a 3-volt lithium button type battery in one embodiment. In another embodiment, the battery can be rechargeable.

The receiving device 200 can be optionally connected to an external device such as a personal computer, a PDA, a memory device or other supervisory system for storage, analysis and archiving, either via its USB port 214 or through additional wireless communication protocol such as IEEE 802.1 VoIg. Vital sign data collected on the receiving device 200 can be then transferred to the external device for further data manipulation, data displaying, data history displaying, data comparisons, data analysis, trend establishment based on the historical data, data archiving, as well as many other operations. When the optional computer system is used for monitoring the vital sign of the living subject, a computer-readable medium having computer-executable instructions is also preferably installed in the computer system. The computer-readable medium preferably includes the instructions for performing one or more of following steps: (a) retrieving vital sign of a living subject from a monitoring device with a USB port or a wireless connection, (b) storing the retrieved vital sign of the living subject into a storage in the computer system, and (c) associating the retrieved vital sign of the living subject with an identity of the living subject. The computer-readable medium may preferably further include instructions for performing some or all of additional steps: retrieving real time vital sign, generating an audible and/or visual alarm in real time when the vital sign exceeds a predetermined threshold, retrieving the vital sign stored in the monitoring device, analyzing the vital sign, establishing a history of the vital sign, displaying the history of the vital sign, and identifying a trend in the vital sign. One or more of elements of the receiving device 200 such as the USB port 214, the audible alarm 210 and the external control 212 can be eliminated without departing from the spirit of the present invention.

Referring now to FIG. 8, an operation flow chart 800 of the receiving device is shown according to one embodiment of the present invention. When the receiving device is powered up, the receiving device is started. The receiving device is initialized as shown in step 804. The memories and registers of the receiving device are initialized, and the receiving device is ready to receive data packet wirelessly from a nearby monitoring device. The receiving device stays in a loop to wait for data packet and the receiving device exits the loop when it receives a data packet from the monitoring device as shown in step 806. When the receiving device receives a data packet, it checks to the type of the data packet as shown in step 808. If the data packet is a "hello" data packet, the receiving device invokes an interrupt routine to let its user to associate the identification of the monitoring device with a living subject using its key entry and to specify the type of vital sign or vital signs being monitored. When such an association is completed, the interrupt routine returns to where it came from as shown in step 818. If the data packet is not a "hello" data packet, it is a regular data packet with measured vital sign data. The receiving device stores the . vital sign data into its memory and displays the real time vital sign measurement as shown in step 810. The receiving device is set in standby mode afterward as shown in step 812 and goes back to step 806 to wait for another data packet transmission. Many steps of the operation can be interrupted by invoking the interrupt routine. If the interrupt routine is invoked, the receiving device first checks if key entry is requested as shown step 814. If key entry is not requested, the next step 820 is to check if a host request is needed. If a host request is needed, the receiving device processes the host request (step 822) and returns from the interrupt (step 818). If the key entry is requested, e. g. to associate a monitoring device with a living subject, the user processes the key entry (step 816) and then returns from the interrupt (step 818).

In the interest of making an inexpensive disposable consumer device, the monitoring device, unlike many previously disclosed devices, is kept purposely simple. Preferably there is no data logging on the monitoring device. The receiving device is initialized to recognize each unique new monitoring device at the time the patch is first powered up. In one embodiment, there is one-way communication from the monitoring device and the receiving device. In this case, the receiving device is preferably activated prior to activating the monitoring device. On the other hand, the receiving device is not consumable and is used repeatedly. In one embodiment, the receiving device receives data packets from one nearby monitoring device, hi another embodiment, the receiving device concurrently receives data packets from multiple nearby monitoring devices 100.

The invention described herein is completely portable, allowing around-the- clock monitoring of a living subject such as human or animal and is intended to provide vital sign profile information to its user.

While there has been shown several and alternate embodiments of the present invention, it is to be understood that certain changes can be made as would be known to one skilled in the art without departing from the underlying scope of the invention as is discussed and set forth above and below including claims. Furthermore, the embodiments described above and claims set forth below are only intended to illustrate the principles of the present invention and are not intended to limit the scope of the invention to the disclosed elements.

Some references, which may include patents, patent applications and various publications, are cited and discussed in the description of this invention. The citation and/or discussion of such references is provided merely to clarify the description of the present invention and is not an admission that any such reference is "prior art" to the invention described herein. AU references cited and discussed in this specification are incorporated herein by reference in their entireties and to the same extent as if each reference was individually incorporated by reference.

Claims

1. A system for monitoring vital signs of a living subject, comprising: a. a monitoring device having an ASIC chip, the ASIC chip including a sensor and a processor, the sensor adapted for collecting a vital sign from an adjacent area of skin of the living subject when activated, the processor in communication with the sensor and adapted for converting the vital sign into data in electronically transmittable format, the monitoring device further including a communication device for receiving the data and transmitting the data wirelessly; and b. a receiving device, adapted for receiving the wireless transmission of data from the monitoring device and processing the data.

2. The system of claim 1, wherein the monitoring device further comprises a protective sheet placed between a surface of the ASIC chip and the area of skin.

3. The system of claim 2, wherein the protective sheet is thermally conductive and includes thermally conductive gel placed thereupon.

4. The system of claim 1, wherein the ASIC chip is pre-calibrated for consistency and accurate vital sign readings.

5. The system of claim 1, wherein the processor comprises a Field Programmable Gate Array (FPGA).

6. The system of claim 1, wherein the processor comprises a Complex Programmable Logic Device (CPLD).

7. The system of claim 1, wherein the communication device includes a transmitter, wherein one-way communication is established from the monitoring device to the receiving device.

8. The system of claim 1, wherein the communication device includes a transceiver and wherein the monitoring device is capable of two-way communication.

9. The system of claim 1, wherein the monitoring device further comprises an antenna in communication with the ASIC chip.

10. The system of claim 9, wherein the antenna is woven into a bandage used to fasten the monitoring device to the area of skin of the living subject.

11. The system of claim 1, wherein the monitoring device further comprises a printed circuit board (PCB).

12. The system of claim 11, wherein an antenna is formed on the surface of the PCB and connects to the ASIC chip.

13. The system of claim 1, wherein the communication device is part of the ASIC chip.

14. The system of claim 1, wherein the monitoring device is attached to the area of skin of the living subject with a bandage or adhesive covering.

15. The system of claim 1, wherein the monitoring device further comprises a thermally non-conductive insolating pad adapted for insulating the sensor from the environment surrounding the area of skin.

16. The system of claim 1, wherein the vital sign is indicative of a physical state of the living subj ect.

17. The system of claim 16, wherein the physical state of the living subject relates to body temperature, the blood, the heart, an organ, a status of the circulatory system, a status of the respiratory system, a status of the blood sugar level, a status of the brain activity, or the status of the well-being of the living subject.

18. The system of claim 1, wherein the receiving device comprises an antenna adapted for receiving the data transmitted from the monitoring device, a controller adapted for controlling operation of the receiving device, a display adapted for displaying information corresponding to the vital sign of the living subject, and an alarm in communication with the controller, and adapted for generating an alert when a threshold related to the vital sign of the living subject is reached.

19. The system of claim 18, wherein the antenna is further adapted for transmitting data and commands to the monitoring device.

20. The system of claim 18, wherein the receiving device further comprises a USB port in communication with the controller and uploading the data related to the vital sign of the living subject to an external device for further data display or archiving.

21. The system of claim 1, wherein the data includes at least one of: sample serial number, frequency at which the monitoring device collects the vital sign, monitoring device identification number, type of the vital sign and vital sign value.

22. A method for monitoring vital signs of a living subject over an extended period of time, comprising the steps of: a. attaching a monitoring device to a predetermined area of skin of the living subject; b. activating the monitoring device; c. using the monitoring device,

(i) collecting the vital sign of the living subject;

(ii) converting the vital sign into data in electronically transmittable format; and

(iii) transmitting the data wirelessly to a receiving device; d. receiving the data at the receiving device; and e. processing the data for further use.

23. The method of claim 22, wherein the step of attaching the monitoring device further comprises placing a protective sheet between a surface of the monitoring device and the predetermined area of skin.

24. The method of claim 22, wherein the step of attaching the monitoring device further comprises attaching the monitoring device to the living subject with a bandage or adhesive covering.

25. The method of claim 22, wherein the step of attaching the monitoring device further comprises the step of attaching the monitoring device adjacent the predetermined area of skin using a thermally conductive adhesive.

26. The method of claim 22, further comprising the step of activating the receiving device prior to the step of activating the monitoring device.

27. The method of claim 22, wherein the step of activating the monitoring device further comprises sending a command from the receiving device.

28. The method of claim 22, further comprising the step of insulating the monitoring device from the environment surrounding the predetermined area of skin.

29. The method of claim 22, wherein the step of collecting the vital sign of the living subject further comprises using a sensor in the monitoring device to obtain information related to a physical state of the living subject.

30. The method of claim 22, wherein the step of collecting the vital sign of the living subject further comprises using a plurality of sensors in the monitoring device to obtain information related to physical states of the living subject.

31. The method of claim 22, wherein the step of processing the data for further use comprises displaying the vital sign of the living subject according to the received data.

32. The method of claim 22, wherein the step of processing the data for further use comprises uploading the data into an external device.

33. The method of claim 22, wherein the step of processing the data for further use comprises generating an alarm when a threshold related to the vital sign of the living subject is reached.

34. An apparatus for monitoring vital signs of a living subject comprising: a. an application specific integrated circuit (ASIC) chip comprising:

(i) a sensor adapted for placement adjacent a predetermined area of skin of the living subject and, when activated, for collecting a vital sign from the predetermined area of skin; and (ii) a processor in communication with the sensor, wherein the processor converts the vital sign obtained by the sensor into data having an electronically transmittable format; and b. a communication device in communication with the processor and adapted for communicating the data wirelessly to a remote receiving device.

35. The apparatus of claim 34, further comprising a protective sheet placed between a surface of the ASIC chip and the predetermined area of skin.

36. The apparatus of claim 35, wherein the protective sheet is thermally conductive and includes a layer of thermally conductive gel placed adjacent the predetermined area of skin.

37. The apparatus of claim 34, wherein the ASIC chip is pre-calibrated for consistency and accurate vital sign readings.

38. The apparatus of claim 34, wherein the processor comprises a Field Programmable Gate Array (FPGA).

39. The apparatus of claim 34, wherein the processor comprises a Complex Programmable Logic Device (CPLD).

40. The apparatus of claim 34, wherein the communication device includes a transmitter and wherein one-way communication is established from the apparatus to the receiving device.

41. The apparatus of claim 34, wherein the communication device includes a transceiver and wherein the apparatus is capable of two-way communication.

42. The apparatus of claim 34, wherein the monitoring device further comprises an antenna in communication with the ASIC chip.

43. The apparatus of claim 34, wherein the antenna is woven into a bandage used to fasten the apparatus to the predetermined area of skin of the living subject.

44. The apparatus of claim 34, wherein the apparatus further comprises a printed circuit board (PCB).

45. The apparatus of claim 44, wherein an antenna is formed on the surface of the PCB and connects to the ASIC chip.

46. The apparatus of claim 34, wherein the communication device is part of the ASIC chip.

47. The apparatus of claim 34, wherein the apparatus is attached to the predetermined area of the skin of the living subject with a bandage or adhesive covering.

48. The apparatus of claim 34, wherein the apparatus further comprises a thermally non-conductive insolating pad adapted for insulating the sensor from the environment surrounding the predetermined area of skin.

49. The apparatus of claim 34, wherein the vital sign of a living subject relates to a signal associated with the state of the living subject.

50. The apparatus of claim 49, wherein the physical state of the living subject relates to body temperature, the blood, the heart, an organ, a status of the circulatory system, a status of the respiratory system, a status of the blood sugar level, a status of the brain activity, or the status of the well-being of the living subject.

51. The apparatus of claim 34, wherein the data includes at least one of: sample serial number, frequency at which the monitoring device collects the vital sign, monitoring device identification number, type of the vital sign and vital sign value.