Title of Invention	AN IMPROVED DIAGNOSTIC DEVICE
Abstract	The present invention relates to an improved diagnostic device useful for capturing and monitoring vital signs such as Blood Pressure, Temperature, ECG, etc. as well as analyzing bio-chemistry parameters and capturing images of the eyes, skin, throat, etc. so as to facilitate quick and precise diagnosis of the condition of an individual (Figure 1). The device of the present invention is capable of being operated from a remote location.

Title of Invention

AN IMPROVED DIAGNOSTIC DEVICE

Abstract

The present invention relates to an improved diagnostic device useful for capturing and monitoring vital signs such as Blood Pressure, Temperature, ECG, etc. as well as analyzing bio-chemistry parameters and capturing images of the eyes, skin, throat, etc. so as to facilitate quick and precise diagnosis of the condition of an individual (Figure 1). The device of the present invention is capable of being operated from a remote location.

Full Text	FIELD OF THE INVENTION The present invention relates to an improved diagnostic device. The device of the present invention is useful for capturing and monitoring vital signs such as Blood Pressure, Temperature, ECG, etc. as well as analyzing bio-chemistry parameters and capturing images of the eyes, skin, throat, etc. so as to facilitate quick and precise diagnosis of the condition of an individual. The device of the present invention is capable of being operated from a remote location. DESCRIPTION OF THE PRIOR ART Devices for measuring various physiological parameters, or 'Vital signs", of a patient such as temperature, blood pressure, heart rate, heart activity, etc. are known and have been a standard part of the medical care for many years. The patient monitoring systems are used for automatically measuring, either continuously or at regular intervals, the values of patient's important physiological parameters. There are several categories of patients who need continuous monitoring, like critically ill patients recovering from surgery, heart attacks or serious illness in the intensive care unit. The generally agreed upon parameters for monitoring include Electrocardiogram (ECG), heart rate, blood pressure, body temperature and respiratory rate. In addition. Electroencephalogram (EEC), oxygen tension (p02) and respiratory volume also form part of these systems. Monitoring in such systems is generally carried out at the bedside, central station and with a central display. There have been several advancements in the recent past over the basic patient monitoring systems, where the systems have been added with diagnostic and alarm capabilities. Such systems interpret the vital signs for detection of abnormalities (e.g. Arrhythmia detection from ECG), and raise an alarm on such conditions so that timely actions can be taken. Several advancements also relate to capturing data from a patient remotely using radio-telemetry techniques, implantable sensors and usage of memory cards or smart cards for storage of the measured data. Radio-telemetry Techniques: A cordless, disposable sensor band characterizes the system described in US Patent 6,416,471 with sensors measuring full waveform ECG, full waveform respiration, skin temperature, and motion, and transmission circuitry for detection and transmission of vital signs data of the patient. A small signal transfer unit that can either be worn by the patient, e.g., on his or her belt, or positioned nearby receives data from the sensor band, which it then forwards by radio transmission to a base station that can be located up to 60 meters away. The base station receives data transmission from the signal transfer unit and is designed to connect to conventional phone lines for transferring the collected data to a remote monitoring station. The base station may also capture additional clinical data, such as blood pressure data, and to perform data checks. The device described in the invention above, is limited to measurement of the physiological parameters only. Also, it depends on a conventional telephone line for connecting to a remote location for sending the measured parameters. Usage of memory cards or smart cards: US Patent 6,454,708 Bl is an extension of the US Patent 6,416,471 and a smart card has been included along with the sensor band's electronics and/or signal transmission circuitry to add a portable data logger. The system of the invention has useful application to the collection of subject clinical data during drug trials and medical testing for regulatory approvals as well as management of subjects with chronic diseases. As has been mentioned this prior art just extends the previous one by adding a storage capability to easily carry the collected data to a different location. But, it still does not extend the measurement to biochemistry parameters. Implantable Sensors: European Patent EP0757541B1 relates to a body implantable pressure sensor lead, particularly, but not exclusively, an endo-cardial lead for implantation in a right heart chamber, for responding to blood and atmospheric pressure and blood temperature and providing modulated pressure and temperature related signals to an implanted or external hemodynamic monitor and/or cardiac pacemaker or pacemaker/cardioverter/defibrillator. Although the procedures mentioned in this prior art are more accurate than the noninvasive procedures, the main limitation is the fact that it requires surgical procedure to place the sensors inside the human body. Some improvements relate to systems with wireless telemetry for monitoring data from several patients in the hospital simultaneously with relative ease. US Patent no. 6,544,173 describes a wireless medical telemetry system which includes a wireless patient monitor configured to collect patient vital signs data, and a central station adapted to establish communication with the patient monitor via a wireless transceiver, and to receive the patient vital signs data from the patient monitor. The patient monitor is operable by a user to transmit an end-communications signal to the central station, and the central station is configured to terminate the communications with the patient monitor in response to the end-communications signal. In this prior art, a wireless mechanism has been utilized for transmission of the measured parameters. But it is still limited to the measurement and transmission of physiological parameters. Another remote diagnostic system has been disclosed in the Japanese Patent Document no. 10-143573. This provides a remote medical care system capable of measuring and diagnosing the biological information of an examinee body over a long period without loading a communication network. This system has been further enhanced in the US Patent 6,497,657 by adding a preliminary-diagnosis device for making a decision whether the patient needs a proper diagnosis to be made by a doctor. Both the prior art mentioned above are limited to the fact that various parameters can be collected from a patient and based on some thresholds, diagnosis is either performed automatically or by a doctor present at a remote location. But how the parameters have been collected by the device, is not covered by either of the prior art. It would be observed from the description above that the devices currently available are useful, once the need for monitoring the patient on a regular basis has been established for a specific reason. However, these devices are of very limited utility for cases where initial diagnosis of the patient is to be done, and the availability of a qualified doctor at the patient location cannot be ensured. Also, in most of the prior art mentioned above, it requires a skilled professional to be available at the same location as the patient to place the electrodes at appropriate locations on the patient's body. In addition, at various remote places, communication facilities may or may not exist, and diagnostic laboratories are not available. In such cases, the existing devices are, again, of a very limited utility. The utility of the existing diagnostic systems is limited only to the physiological parameters and does not cover the biochemistry parameters, e.g. Blood Sugar or Urine tests. Therefore the main objective of the present invention is to provide an improved diagnostic device, which overcomes the limitations of the prior art devices. Another objective of the present invention is to provide an improved diagnostic device, which collects various parameters (not limited to the physiological parameters), enabling the doctor to make accurate diagnosis, which avoids the difficulties of the hitherto known remote patient monitoring systems. Still another objective of the present invention is to provide an improved diagnostic device, which can also measure the biochemistry parameters (using the blood and urine samples) and perform an analysis of the measured parameter. Yet another objective of the present invention is to provide an improved diagnostic device, which is portable and integrated and automatic. Yet another objective of the present invention is to provide an improved diagnostic device, which allows the data, captured through the device to be used by the doctor for arriving at a correct and precise diagnosis of the patient. Yet another objective of the present invention is to provide an improved diagnostic device which could be used at homes for preventive care, and which alerts the individual of any suspected abnormalities, who then could be transferred or carried to the doctor for further diagnosis, if required. Yet another objective of the present invention is to provide an improved diagnostic device, which can be operated by a relatively untrained person with ease, in remote areas without necessitating the presence of a trained medical professional at the point of care. BRIEF DESCRIPTION OF THE DRAWINGS The above objectives have been achieved by developing an improved diagnostic device, which is described with reference to the drawings accompanying this specification. In the drawings Figure 1 represents a plan view of the improved diagnostic device of the present invention. Figure 2 shows the embodiment of the working of the device between a patient at a remote location and a doctor location. Figure 3 shows the software user interface, which has been designed for the operation of the device. Figure 4 shows the usage of the device in a standalone mode SUMMARY OF THE INVENTION According to the present invention, there is provided an Improved Diagnostic Device which comprises (A) Sensors for sensing Temperature, Blood Pressure, comprising of a cuff having two tubes which come out of the cuff, one of which is connected to a bulb, used to inflate the cuff and the other one is connected to a pressure transducer for converting the pressure in the cufF into an electrical signal for sending the signal to the Amplification Unit, Electro Cardio Graph (ECG) comprising of four clip electrodes capable of being connected to the four limbs of the patient and six bulb electrodes to be placed at various pre-specified positions on the chest of the patient and Electronic Stethoscope comprising of a normal stethoscope diaphragm connected by an air column to a transducer for sensing the changes in pressure in the air column caused by the sounds of the heart and lungs of the patient each said means having a terminal which is capable of being connected or placed in contact with the patient who has to be diagnosed and another terminal capable of being connected to an Amplification Unit (8), (B) Means (5) for analyzing blood samples provided with a slot for inserting a strip containing the sample which is to be tested and a terminal for being connected to a Microcontroller Unit (11), (C) Means (6) for analyzing urine samples, comprising image capturing equipment with control over the timing of the capture of the image, reference color images for analysis mechanical arrangement for hosting the image capturing equipment, and test strips; a slot is provided for inserting the strip containing the sample, which is to be tested and having a terminal which is connected to an Image Capture Unit (7), (D) An Image Capture Unit (7) comprising of a web camera unit capable of capturing high resolution images of the skin, eyes, ear and throat or any other externally visible parts of the body of the patient for diagnosis of the related ailments, the unit having a terminal for being connected to a Computation Unit (19), (E) An Amplification Unit (8), provided with multiple input terminals, each of which is connected to one of the above said sensors, and another terminal being the output terminal and is connected to an Analog Filter Unit (9), (F) An Analog Filter Unit (9), provided with one terminal connected to the Amplification Unit (8) for receiving the amplified input analog signal, and another terminal being the output terminal and provided with a filtered signal to the Digitization Unit (10), (G) A Digitization Unit (10), provided with one terminal connected to the Analog Filter Unit (9) for receiving the filtered signal as input and another terminal being the output terminal for providing a digitized signal to the Microcontroller Unit (11), (H) A Microcontroller Unit (11), provided with multiple terminals, one of which being the first input terminal, capable of being connected to the Digitization Unit (10) for receiving the digitized signal as input, another terminal being the output terminal, and for providing the data to a Modulating Unit (12), another terminal being the second input terminal, connected to the Demodulating Unit (13) to receive the demodulated signal, and another terminal being the ou^ut terminal and connected to the Mode Selection Unit (14), (I) A Mode Selection Unit (14), provided with multiple terminals, one of which being the input terminal and connected to the Microcontroller Unit (11), multiple output terminals connected to each of the above said sensors for activating the said sensors and multiple output terminals connected to the LED's in each sensor circuitry for indicating the parameter being measured, (J) A Modulating Unit (12), provided with one terminal connected to the Microcontroller Unit (11) for receiving the data to be modulated, and another terminal connected to a Wireless Transceiver Unit (15) for providing the modulated signal to the Wireless Transceiver Unit (15), (K) A Demodulating Unit (13), provided with one terminal connected to the Wireless Transceiver Unit (15) for receiving the modulated signal and another terminal connected to the Microcontroller Unit (11) for providing a demodulated signal, (L) A Wireless Transceiver Unit (15), provided with multiple terminals, one of which being the first input terminal connected to the Modulating Unit (12) for receiving the modulated signal, another terminal being the second input terminal connected to a second Wireless Transceiver Unit (16) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal being connected to the second Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal which being the second output terminal connected to the Demodulating Unit (13) for providing a modulated signal, (M) A second Wireless Transceiver Unit (16), provided with multiple terminals, one of which being the first input terminal connected to the second Modulating Unit (18) for receiving the modulated signal, another terminal being the second input terminal connected to the first Wireless Transceiver Unit (15) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal connected to the first Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal being the second output terminal connected to the second Demodulating Unit (17), for providing a modulated signal, (N) A second Demodulating Unit (17), having one terminal connected to the second Wireless Transceiver Unit (16) to receive the modulated signal and another terminal connected to the Computation Unit (19) to provide the demodulated signal. (O) A second Modulating Unit (18), having one terminal connected to the Computation Unit (19) to receive the data from the Computation Unit (19), and another terminal connected to the second Wireless Transceiver Unit (16) and provides the modulated signal to the second Wireless Transceiver Unit (16), (P) A Charging Unit (20), having one terminal connected to the AC mains and another terminal connected to the Electrical Isolation Unit (21), (Q) An Electrical Isolation Unit (21), having one terminal connected to the Charging Unit (20) and another terminal connected to the Battery Unit (22) and (R) A Battery Unit (22), having one terminal connected to the Electrical Isolation Unit (21) and another terminal connected to all electronic components of the device for providing power to each of the components. Sensor for Temperature measurement comprises of a thermistor which when placed in contact with the patient's body, preferably in the armpit, picks up the skin temperature, which then is converted to an electrical signal and is sent to the Amplification Unit. In the presently preferred embodiment, the thermistor has a range of 90*^? to 1 lO^F with an error margin of about +0.1oF Sensor for Blood Pressure measurement comprises of a cuff. There are two tubes, which come out of the cuff, one of which is connected to a bulb, used to inflate the cuff, and the other one is connected to a pressure transducer, which converts the pressure in the cuff into an electrical signal and sends the signal to an Amplification Unit. Blood Pressure is measured in a semi-automatic and non-invasive fashion, by tying the cuff around the upper arm of the patient. The assembly allows the operator to inflate the cuff manually but the deflation happens automatically at a constant rate. The data, collected by the device is processed by the PC software for calculation of the Blood Pressure and Pulse Rate. The algorithm uses the periodic pulses created by the pumping of blood through the veins and sensed by the pressure sensor. Sensor for ECG comprises of four clip electrodes to be connected to the four limbs of the patient and six bulb electrodes to be placed at various pre-specified positions on the chest of the patient. These electrodes are coimected through special cables and coimectors to the Amplification Unit. The leads for each of these electrodes terminates in a small PCB mounted on a circular disc. The disc is arranged such that, the cables can be retracted and stored as a compact bundle. The electronic stethoscope comprises of a normal stethoscope diaphragm connected by an air column to a transducer, which senses the changes in pressure in the air column caused by the sounds of the heart and lungs, when the stethoscope is placed at various positions on the chest and back of the patient. These sounds are converted to an electrical signal and sent to the Amplification Unit. The system employs a method for dry-chemistry analysis for blood and urine, using the above device. It captures the image of the test and reference strips and compares the images for closeness of color and intensity determines the closest match by measuring the distance of each of the Red, Green and Blue components in terms of their visual weights displays and stores the result The blood and urine tests may be carried out by taking a blood or urine sample and putting a small quantity of the sample on a test strip, made up of some enzymes or reagents. The chemical composition of the strip is such that it results in a colour change when the sample is put on the strip. Also, the colour change corresponds to the condition of the patient. The colour of the strip is compared with the colour of the reference strip available either as a chart or in the PC software database Means for capturing images may comprise of a web camera unit, which is capable of capturing high-resolution images of the skin, eyes, ear and throat or any other externally visible parts of the body for diagnosis of the related ailments, e.g. rashes on the skin or infection of the eyes or soreness of the throat. Any other mechanism, which allows capture of images, could also be used. The Amplification Unit may comprise of operational amplifiers and other electronic components, which multiply the input signal with a pre-determined, gain and provide the output signal to the Analog Filter Unit The Analog Filter Unit may comprise of circuitry to filter out the unwanted frequencies fi"om signals received from each of the sensors. The signal received from the Temperature and Blood Pressure sensors are filtered to separate out the DC components of the signals. Signal received from the ECG sensors is passed through a first order filter with a cut-off frequency of 200 Hz, while the signal received from the Stethoscope sensor is filtered using a sixth order filter with a cut-off frequency of 400 Hz. The Digitization Unit may comprise of analog to digital converter circuitry, which samples the incoming signals at 8-bit resolution and 960 Hz, which is more than the Nyquist frequency for the signals after they have passed through the Analog Filter Unit. The Microcontroller Unit may comprise of various standard components, e.g. Arithmetic and Logic Unit, Register Bank etc. It receives the input signal from the Digitization Unit and formats the digitized data to be sent over the wireless link. The Mode Selection Unit may comprise of electronic circuitry, which enables a particular mode whenever a command is received by the Microcontroller Unit from the Computation Unit over the wireless link. Whenever a particular mode is selected, the LED corresponding to that mode is also switched ON as an indication to the user. As an example of Computation Unit, it may be mentioned that a Personal Computer can be used, though that is not the only way. The Modulating Unit may comprise of a periodic waveform generator and additional circuitry, which generates a carrier frequency of 460 KHz. This carrier signal is modulated by the signal received from the Microcontroller Unit and sent to the Wireless Transceiver Unit for transmission to the other end. The Demodulating Unit may have the same circuitry as the Modulating Unit to generate the carrier frequency. The received signal is demodulated using the generated carrier frequency and the demodulated signal is send to the Microcontroller Unit for further processing. The Wireless Transceiver Unit comprises of transmitter and receiver circuitry to communicate with another Wireless Transceiver Unit. As an example of Wireless Transceiver Unit, it may be mentioned that Infrared LED's can be used for communication though they are not the only means. A second set of each of Wireless Transceiver Unit, Modulating Unit and Demodulating Unit may be connected to a Computation Unit. The Charging Unit may comprise of a step-down transformer and additional electronic components to charge the Battery Unit. The Electrical Isolation Unit (21) may comprise of a switch, which selects one of the two modes of operation. In one position, the Improved Diagnostic Device goes into charging mode, and the battery is being charged. At this time, the device is not operational and none of the parameters can be measured. In the other position of the switch, the Improved Diagnostic Device goes into operational mode and any of the parameters can be measured. At this time, the path with the AC mains is completely cut-oflf The Battery Unit (22) may be a rechargeable battery pack. This provides electrical power for about 20 hours of continuous operation after about 4 hours of charging. The Microcontroller Unit (11) and the rest of the processing and transmission circuitry may be mounted on a flexible or rigid PCB, which may also contain passive components such as resistors and capacitors, a crystal, and connections. The PCB may be connected to a set of connectors providing connections to the various sensors. DESCRIPTION OF THE SOFTWARE The software provided as part of the device of the present invention runs on a Computation Unit, in this case a Personal Computer running any Windows operating system. The software has been developed using Visual C~H- and Windows APFs. The software has also been integrated with independent Video Conferencing software to create a complete solution for a doctor-patient session to be carried out more effectively. The software solution includes maintenance of medical records for all patients in a central database. This database is maintained on an independent server (which is another Computation Unit) and information is stored in standard formats like HL7. Any of the client Computation Units can make SQL queries to access and store information in the database. Algorithms have been implemented to maintain sanctity and security of the database. The communication between any two Computation Units uses two channels for communication, a reliable channel for all medical data and a slightly less reliable channel for all speech and video data. The reliability of the channel for speech and video depends on bandwidth availability. The software comprises of various signal-processing algorithms to digitally filter and process the data to enhance the signal quality for further processing. Such algorithms include artifact detection and filtering and 50/60 Hz Notch filters for removal of mains noise. It also has algorithms, which perform calibration of the data as well as perform computation of Blood Pressure, Pulse Rate and R-R interval. It also has algorithms to perform comparison of the captured images with reference images to perform biochemistry analysis. The software connects to the second Wireless Transceiver Unit and through that, to the Improved Diagnostic Device. It also has the ability to detect various conditions like the connectivity with the Improved Diagnostic Device; low battery condition on the device and ECG leads-OFF wherein the leads have not been connected while taking the ECG of the patient. The software uses an ID for each type of the signal being measured to identify which signal is being measured. It also helps in keeping a check on the health of the system by making sure that the device is measuring the parameter that the software has requested. It also comprises of a front-end graphical user interface (GUI), which has various buttons and screens that enable the user to select the parameter to be measured and start and stop the measurement. The GUI also plots the ECG and Stethoscope signals. The GUI also provides an interface to create new patient records and retrieve information about the existing patient records. The software also provides an interface to store the various measured parameters to the database. The GUI also provides an ability to print the information in the patient record, including the plots for ECG and Stethoscope and the results of various parameter measurements. The software also has the ability to play out the Stethoscope signal on the audio port of the Computation Unit. All the while, the doctor and patient can be connected through a video conferencing link and can see and talk to each other. The software also provides a standalone mode of operation, wherein the doctor and patient are in the same location. In this case, the video conferencing session is not required but the Computation Unit has to be connected to the database server for storing the freshly taken measurements. Existing measurements in the database can be retrieved for reference, if required. OPERATION OF THE DEVICE The POWER switch on the front panel activates the remote diagnostic kit at the remote location. At this stage, the device is operated with a battery pack placed inside the kit. Low battery is indicated by an LED on the front panel, based on which, the user can recharge the batteries. As shown in Figure 2, the front-end graphical user interface on the Patient End Computation Unit is activated and it establishes communication with the device, as shown in Figure 1 and described above. Successfiil establishment of connection is indicated at the display of the Patient End Computation Unit. In a preferred embodiment, the communication unit is a wireless modem that receives the data from the patient computation unit. This data is then formatted and modulated appropriately, and sent across the communication channel. This communication unit also receives data across the communication channel from the doctor's location, and sends this across to the patient end computation unit after demodulation. Such data typically is • The communication between the doctor and the patient/operator, • Indication of which tests are to be performed on the patient or • Diagnosis and Prescription In the presently preferred embodiment, a similar or better communication unit and computation unit exist at the doctor's location, where the data is received via the communication channel by the communication unit, demodulated and sent to the computation unit for either display, interpretation or storage purposes. In the presently preferred embodiment, the computation unit at the doctor's location could be a Computation Unit with the facility to display, store and perform necessary computation power for interpretive diagnosis. In the presently preferred embodiment, Graphical User Interface on the Display Unit allows the user to select the parameters to be measured and viewed on the screen. In the present embodiment, only one parameter can be measured at any given time. The transducer corresponding to the physiological parameter being measured must be connected to the kit using the appropriate connector. The electrodes for measuring various physiological parameters should be placed on appropriate parts of the body. The device must have been switched ON and activated using the software at the patient location. For the parameter to be measured, the doctor has to press the Start button on his User Interface for the respective parameter. The command is sent to the Patient End Computation Unit over the Communication Channel and subsequently to the Improved Diagnostic Device over the Wireless link. This activates the selected parameter and the device starts collecting data from the respective sensor. To measure temperature, the temperature probe has to be placed under the armpit of the patient. Doctor can then start the measurement by pressing the start button for the temperature. The software starts collecting data from the sensor and continues to collect samples until the temperature reaches a steady state value. All this while, the temperature reading is displayed on both. Patient and Doctor Computation Units. To measure Blood Pressure, the patient or operator has to tie the Blood Pressure cuff around the upper arm of the patient and close the valve. Once the doctor presses the Start button for Blood Pressure, the patient or operator can start inflating the cuff After a certain threshold has been reached the software prompts the patient or operator to stop inflating. The deflation happens automatically and after the cuff has sufficiently deflated, the software algorithm calculates the Systolic and Diastolic pressure values as well as the pulse rate of the patient. All three values are displayed on both Patient and Doctor Computation Units. To measure ECG, the operator has to connect all the leads to appropriate positions on the body of the patient, which are the four limbs and the standard VI through V6 positions on the chest of the patient. Once the doctor presses the Start button for the ECG and selects the lead to be observed, the software starts to plot the ECG for the respective lead. In the present embodiment, the doctor can choose from among the leads individually or capture all leads simultaneously. The signals are captured for a fixed duration and the collection of samples stops, once the data has been captured completely. R-R interval and Pulse rate are also calculated and displayed along with the plot. To listen to sounds from the chest and back of the patient, the doctor has to press the Start button for the Stethoscope. The operator has to place the Stethoscope on the various positions on the chest and back of the patient, as instructed by the doctor over the Communication Link. There is provision to connect the signals to the audio port at the Patient and Doctor End Computation Units. Typical headphone socket interface is provided for hearing the audio output To perform Blood Glucose test, the operator has to place a drop of blood on a strip and insert the strip in the slot provided. Once the doctor presses the Start button, the sample is analyzed and the result sent to the software through the device and subsequently to the doctor. To perform Urine Sample Analysis, the sample is placed on the strip and results in a colour change. This strip is then placed in front of the image capture means, e.g. a web camera. Once the doctor presses the Start button, the image capture means grabs a snapshot and sends it to the Doctor End Computation Unit. The software at both ends performs a comparison with a reference set of images and presents the results to the doctor. To view images of the skin, eyes, ear, throat or any other parts of the body, the respective part of the body has to be brought in front of the image capture means. The captured image is sent to the doctor who can then perform diagnosis of the condition of the patient. In a Standalone Mode of operation, it is assumed that the doctor and patient are in the same location. All operations that were performed by the doctor as described above can be done locally for measurement of each of the parameters. The user interface remains the same and only difference is that the commands and data is not sent over the Communication Channel and is handled locally. In a preferred embodiment, additional data, such as full waveform respiration, motion detection and EEG may also be collected and provided to the device for further processing. Electrical or other characteristics may be used for the analysis of blood and urine. The dry chemistry sensors may be replaced with wet chemistry sensors for the blood and urine tests, along with the appropriate chemical reagents or enzymes. The system may be used for the tests other than blood and urine tests. In that case the same color change or electrical or other characteristics detection mechanism may be used. The system may have the capability to display the additional physiological, biochemistry and image capture analysis and the results. The system may also be provided with means for making references for the biochemistry tests. The arrangement for passing the patient symptoms to the doctor and/or a mechanism for the doctor and the patient to communicate may be provided in one or more forms like text, auditory or video signals over the available communication channel, to aid the diagnosis process. Further, this data can be packaged in various standard formats like HL7 etc. In further embodiment, the functionality of the Microcontroller Unit (11) and some of the associated circuitry could be implemented in ASIC, using techniques known in the art. The signal conditioning and processing system useful for capturing the signals from the above sensors and equipment for the purpose of one or more of amplification, filtering, and digitization may be arranged in any sequence. In yet another embodiment, the communication unit and the signal conditioning and processing units may be integrated into one single unit. The system may be provided with automatic diagnostic aid capability (or the interpretation of various conditions of the patient), on the basis of one or more of the parameters captured. In addition, the system may also have the facility of communicating the diagnostic aid (or the interpretation) to the medical practitioner or for storage purposes with a wire line communication. Further the system may also have the facility of communicating the diagnostic aid (or the interpretation) to the medical practitioner or for storage purposes with a wire less communication. Further more the system may be provided with the facility of continuously monitoring one or more of the parameters captured. There may also be a facility of recording the continuously monitored parameters and interpretations In still another embodiment, the Device and the Computation Unit could communicate with each other using other means of communication and not limited to the wireless communication. It is to be understood that the present invention may be embodied with other changes, improvements and modifications that may occur to one skilled in the art without departing from the spirit and scope of the invention. ADVANTAGES OF THE INVENTION The Device is an integrated solution for the initial diagnosis of a patient located far from the doctor and / or in the diagnostic laboratories. The Device in addition to the facility of monitoring the physiological parameters also integrates the capability for biochemistry analysis, and visual signal communication in the remote unit. The Device can be used for personal preventive healthcare purposes at home locations. The Device provides an excellent medical diagnosis means for rural population because of being able to capture multiple parameters (and not only physiological), and using multiple of text, audio and visual signals simultaneously for the patient-doctor communication. The Device can be used by relatively untrained (non-medical professionals) at the point of care remote places. We Claim 1. An Improved Diagnostic Device, which comprises (A) Sensors for sensing Temperature, Blood Pressure comprising of a cufF having two tubes which come out of the cuff, one of which is connected to a bulb, used to inflate the cuff and the other one is connected to a pressure transducer for converting the pressure in the cuff into an electrical signal for sending the signal to the Amplification Unit, Electro Cardio Graph (ECG) comprising of four clip electrodes capable of being connected to the four limbs of the patient and six bulb electrodes to be placed at various pre-specified positions on the chest of the patient and Electronic Stethoscope comprising of a normal stethoscope diaphragm connected by an air column to a transducer for sensing the changes in pressure in the air column caused by the sounds of the heart and lungs of the patient each said means having a terminal which is capable of being connected or placed in contact with the patient who has to be diagnosed and another terminal capable of being connected to an Amplification Unit (8), (B) Means (5) for analyzing blood samples provided with a slot for inserting a strip containing the sample which is to be tested and a terminal for being connected to a Microcontroller Unit (11), (C) Means (6) for analyzing urine samples, comprising image capturing equipment with control over the timing of the capture of the image, reference color images for analysis mechanical arrangement for hosting the image capturing equipment, and test strips; a slot is provided for inserting the strip containing the sample, which is to be tested and having a terminal which is connected to an Image Capture Unit (7), (D) An Image Capture Unit (7) is a web camera unit capable of capturing high resolution images of the skin, eyes, ear and throat or any other externally visible parts of the body of the patient for diagnosis of the related ailments, the unit having a terminal for being connected to a Computation Unit (19), (E) An Amplification Unit (8), provided with multiple input teraiinals, each of which is connected to one of the above said sensors, and another terminal being the output terminal and is connected to an Analog Filter Unit (9), (F) An Analog Filter Unit (9), provided with one terminal connected to the Amplification Unit (8) for receiving the amplified input analog signal, and another terminal being the output terminal and provided with a filtered signal to the Digitization Unit (10), (G) A Digitization Unit (10), provided with one terminal connected to the Analog Filter Unit (9) for receiving the filtered signal as input and another terminal being the output terminal for providing a digitized signal to the Microcontroller Unit (11), (H) A Microcontroller Unit (11), provided with multiple terminals, one of which being the first input terminal, capable of being connected to the Digitization Unit (10) for receiving the digitized signal as input, another terminal being the output terminal, and for providing the data to a Modulating Unit (12), another terminal being the second input terminal, connected to the Demodulating Unit (13) to receive the demodulated signal, and another terminal being the output terminal and connected to the Mode Selection Unit (14), (I) A Mode Selection Unit (14), provided with miiltiple terminals, one of which being the input terminal and connected to the Microcontroller Unit (11), multiple output terminals connected to each of the above said sensors for activating the said sensors and multiple output terminals connected to the LED's in each sensor circuitry for indicating the parameter being measured, (J) A Modulating Unit (12), provided with one terminal connected to the Microcontroller Unit (11) for receiving the data to be modulated, and another terminal connected to a Wireless Transceiver Unit (15) for providing the modulated signal to the Wireless Transceiver Unit (15), (K) A Demodulating Unit (13), provided with one terminal connected to the Wireless Transceiver Unit (15) for receiving the modulated signal and another terminal connected to the Microcontroller Unit (11) for providing a demodulated signal, (L) A Wireless Transceiver Unit (15), provided with multiple terminals, one of which being the first input terminal connected to the Modulating Unit (12) for receiving the modulated signal, another terminal being the second input terminal connected to a second Wireless Transceiver Unit (16) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal connected to the second Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal which being the second output terminal connected to the Demodulating Unit (13) for providing a modulated signal, (M) A second Wireless Transceiver Unit (16), provided with mxxltiple terminals, one of which being the first input terminal connected to the second Modulating Unit (18) for receiving the modulated signal, another terminal being the second input terminal connected to the first Wireless Transceiver Unit (15) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal being connected to the first Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal being the second output terminal connected to the second Demodulating Unit (17), for providing a modulated signal, (N) A second Demodulating Unit (17), having one terminal connected to the second Wireless Transceiver Unit (16) to receive the modulated signal and another terminal connected to the Computation Unit (19) to provide the demodulated signal, (O) A second Modulating Unit (18), having one terminal connected to the Computation Unit (19) to receive the data from the Computation Unit (19), and another terminal connected to the second Wireless Transceiver Unit (16) and provides the modulated signal to the second Wireless Transceiver Unit (16), (P) A Charging Unit (20), having one terminal connected to the AC mains and another terminal connected to the Electrical Isolation Unit (21), (Q) An Electrical Isolation Unit (21), having one terminal connected to the Charging Unit (20) and another terminal connected to the Battery Unit (22) and (R) A Battery Unit (22), having one terminal connected to the Elertrical Isolation Unit (21) and another terminal connected to all electronic components of the device for providing power to each of the components. 2. An improved diagnostic device as claimed in claim 1 wherein the Sensor for Temperature measurement comprises of a thermistor 3. An improved diagnostic device as claimed in claim 2 wherein the thermistor has a range of 90^F to I lOT^ with an error margin of about ±0. IT^ 4. An improved diagnostic device as claimed in claims 1 to 3 wherein the Amplification Unit comprises of operational amplifiers and other electronic components, which multiply the input signal with a pre-determined gain and provide the output signal to the Analog Fiher Unit. 5. An improved diagnostic device as claimed in claims 1 to 4 wherein the Analog Filter Unit comprises of circuitry to filter out the unwanted frequencies irom signals received from each of the sensors. 6. An improved diagnostic device as claimed in claims 1 to 5 wherein the Digitization Unit comprises of analog to digital converter circuitry for sampling the incoming signals 7. An improved diagnostic device as claimed in claims 1 to 6 wherein the Microcontroller Unit comprises of various standard components such as Arithmetic and Logic Unit and Register Bank. 8. An improved diagnostic device as claimed in claims 1 to 7 wherein the Mode Selection Unit comprises of electronic circuitry for enabling a particular mode whenever a command is received by the Microcontroller Unit from the Computation Unit over the wireless link. 9. An improved diagnostic device as claimed in claims 1 to 8 wherein the Modulating Unit comprises of a periodic waveform generator and additional circuitry for generating a carrier frequency of 460 KHz. 10. An improved diagnostic device as claimed in claims 1 to 9 wherein the Demodulating Unit has the same circuitry as the Modulating Unit for generating the carrier frequency. 11. An improved diagnostic device as claimed in claims 1 to 10 wherein the Wireless Transceiver Unit comprises of a transmitter and receiver circuitry to communicate with another Wireless Transceiver Unit, through wireless communication, including but not limited to Lifrared Communication. 12. An improved diagnostic device as claimed in claims 1 to 11 wherein the second set of each of Wireless Transceiver Unit, Modulating Unit and Demodulating Unit being connected to a Computation Unit. 13. An improved diagnostic device as claimed in claims 1 to 13 wherein the Charging Unit comprises of a step-down transformer and additional electronic components to charge the Battery Unit. 14. An improved diagnostic device as claimed in claims 1 to 13 wherein the Electrical Isolation Unit (21) comprises of a switch, which selects one of the two modes of operation. 15. An improved diagnostic device as claimed in claims 1 to 14 wherein the Battery Unit (22) is a rechargeable battery pack, which provides electrical power for about 20 hours of continuous operation after about 4 hours of charging. 16. An improved diagnostic device as claimed in claims 1 to 15 wherein the Microcontroller Unit (11) and the rest of the processing and transmission circuitry are mounted on a flexible or rigid PCB which also contain passive components such as resistors and capacitors, a crystal, and connections. 17. An improved diagnostic device substantially as herein described with reference to the Fig 1 to 4 of the drawing accompanying this specification

Full Text

FIELD OF THE INVENTION
The present invention relates to an improved diagnostic device. The device of the present invention is useful for capturing and monitoring vital signs such as Blood Pressure, Temperature, ECG, etc. as well as analyzing bio-chemistry parameters and capturing images of the eyes, skin, throat, etc. so as to facilitate quick and precise diagnosis of the condition of an individual. The device of the present invention is capable of being operated from a remote location.
DESCRIPTION OF THE PRIOR ART
Devices for measuring various physiological parameters, or 'Vital signs", of a patient such as temperature, blood pressure, heart rate, heart activity, etc. are known and have been a standard part of the medical care for many years. The patient monitoring systems are used for automatically measuring, either continuously or at regular intervals, the values of patient's important physiological parameters.
There are several categories of patients who need continuous monitoring, like critically ill patients recovering from surgery, heart attacks or serious illness in the intensive care unit. The generally agreed upon parameters for monitoring include Electrocardiogram (ECG), heart rate, blood pressure, body temperature and respiratory rate. In addition. Electroencephalogram (EEC), oxygen tension (p02) and respiratory volume also form part of these systems. Monitoring in such systems is generally carried out at the bedside, central station and with a central display.
There have been several advancements in the recent past over the basic patient monitoring systems, where the systems have been added with diagnostic and alarm capabilities. Such systems interpret the vital signs for detection of abnormalities (e.g. Arrhythmia detection from ECG), and raise an alarm on such conditions so that timely actions can be taken.

Several advancements also relate to capturing data from a patient remotely using radio-telemetry techniques, implantable sensors and usage of memory cards or smart cards for storage of the measured data.
Radio-telemetry Techniques: A cordless, disposable sensor band characterizes the system described in US Patent 6,416,471 with sensors measuring full waveform ECG, full waveform respiration, skin temperature, and motion, and transmission circuitry for detection and transmission of vital signs data of the patient. A small signal transfer unit that can either be worn by the patient, e.g., on his or her belt, or positioned nearby receives data from the sensor band, which it then forwards by radio transmission to a base station that can be located up to 60 meters away. The base station receives data transmission from the signal transfer unit and is designed to connect to conventional phone lines for transferring the collected data to a remote monitoring station. The base station may also capture additional clinical data, such as blood pressure data, and to perform data checks.
The device described in the invention above, is limited to measurement of the physiological parameters only. Also, it depends on a conventional telephone line for connecting to a remote location for sending the measured parameters.
Usage of memory cards or smart cards: US Patent 6,454,708 Bl is an extension of the US Patent 6,416,471 and a smart card has been included along with the sensor band's electronics and/or signal transmission circuitry to add a portable data logger. The system of the invention has useful application to the collection of subject clinical data during drug trials and medical testing for regulatory approvals as well as management of subjects with chronic diseases.
As has been mentioned this prior art just extends the previous one by adding a storage capability to easily carry the collected data to a different location. But, it still does not extend the measurement to biochemistry parameters.

Implantable Sensors: European Patent EP0757541B1 relates to a body implantable pressure sensor lead, particularly, but not exclusively, an endo-cardial lead for implantation in a right heart chamber, for responding to blood and atmospheric pressure and blood temperature and providing modulated pressure and temperature related signals to an implanted or external hemodynamic monitor and/or cardiac pacemaker or pacemaker/cardioverter/defibrillator.
Although the procedures mentioned in this prior art are more accurate than the noninvasive procedures, the main limitation is the fact that it requires surgical procedure to place the sensors inside the human body.
Some improvements relate to systems with wireless telemetry for monitoring data from several patients in the hospital simultaneously with relative ease. US Patent no. 6,544,173 describes a wireless medical telemetry system which includes a wireless patient monitor configured to collect patient vital signs data, and a central station adapted to establish communication with the patient monitor via a wireless transceiver, and to receive the patient vital signs data from the patient monitor. The patient monitor is operable by a user to transmit an end-communications signal to the central station, and the central station is configured to terminate the communications with the patient monitor in response to the end-communications signal.
In this prior art, a wireless mechanism has been utilized for transmission of the measured parameters. But it is still limited to the measurement and transmission of physiological parameters.
Another remote diagnostic system has been disclosed in the Japanese Patent Document no. 10-143573. This provides a remote medical care system capable of measuring and diagnosing the biological information of an examinee body over a long period without loading a communication network. This system has been further enhanced in the US

Patent 6,497,657 by adding a preliminary-diagnosis device for making a decision whether the patient needs a proper diagnosis to be made by a doctor.
Both the prior art mentioned above are limited to the fact that various parameters can be collected from a patient and based on some thresholds, diagnosis is either performed automatically or by a doctor present at a remote location. But how the parameters have been collected by the device, is not covered by either of the prior art.
It would be observed from the description above that the devices currently available are useful, once the need for monitoring the patient on a regular basis has been established for a specific reason. However, these devices are of very limited utility for cases where initial diagnosis of the patient is to be done, and the availability of a qualified doctor at the patient location cannot be ensured. Also, in most of the prior art mentioned above, it requires a skilled professional to be available at the same location as the patient to place the electrodes at appropriate locations on the patient's body. In addition, at various remote places, communication facilities may or may not exist, and diagnostic laboratories are not available. In such cases, the existing devices are, again, of a very limited utility.
The utility of the existing diagnostic systems is limited only to the physiological parameters and does not cover the biochemistry parameters, e.g. Blood Sugar or Urine tests.
Therefore the main objective of the present invention is to provide an improved diagnostic device, which overcomes the limitations of the prior art devices.
Another objective of the present invention is to provide an improved diagnostic device, which collects various parameters (not limited to the physiological parameters), enabling the doctor to make accurate diagnosis, which avoids the difficulties of the hitherto known remote patient monitoring systems.

Still another objective of the present invention is to provide an improved diagnostic device, which can also measure the biochemistry parameters (using the blood and urine samples) and perform an analysis of the measured parameter.
Yet another objective of the present invention is to provide an improved diagnostic device, which is portable and integrated and automatic.
Yet another objective of the present invention is to provide an improved diagnostic device, which allows the data, captured through the device to be used by the doctor for arriving at a correct and precise diagnosis of the patient.
Yet another objective of the present invention is to provide an improved diagnostic device which could be used at homes for preventive care, and which alerts the individual of any suspected abnormalities, who then could be transferred or carried to the doctor for further diagnosis, if required.
Yet another objective of the present invention is to provide an improved diagnostic device, which can be operated by a relatively untrained person with ease, in remote areas without necessitating the presence of a trained medical professional at the point of care.
BRIEF DESCRIPTION OF THE DRAWINGS
The above objectives have been achieved by developing an improved diagnostic device, which is described with reference to the drawings accompanying this specification. In the drawings
Figure 1 represents a plan view of the improved diagnostic device of the present invention.
Figure 2 shows the embodiment of the working of the device between a patient at a remote location and a doctor location.

Figure 3 shows the software user interface, which has been designed for the operation of the device.
Figure 4 shows the usage of the device in a standalone mode
SUMMARY OF THE INVENTION
According to the present invention, there is provided an Improved Diagnostic Device which comprises
(A) Sensors for sensing Temperature, Blood Pressure, comprising of a cuff having two tubes which come out of the cuff, one of which is connected to a bulb, used to inflate the cuff and the other one is connected to a pressure transducer for converting the pressure in the cufF into an electrical signal for sending the signal to the Amplification Unit, Electro Cardio Graph (ECG) comprising of four clip electrodes capable of being connected to the four limbs of the patient and six bulb electrodes to be placed at various pre-specified positions on the chest of the patient and Electronic Stethoscope comprising of a normal stethoscope diaphragm connected by an air column to a transducer for sensing the changes in pressure in the air column caused by the sounds of the heart and lungs of the patient each said means having a terminal which is capable of being connected or placed in contact with the patient who has to be diagnosed and another terminal capable of being connected to an Amplification Unit (8),
(B) Means (5) for analyzing blood samples provided with a slot for inserting a strip containing the sample which is to be tested and a terminal for being connected to a Microcontroller Unit (11),
(C) Means (6) for analyzing urine samples, comprising image capturing equipment with control over the timing of the capture of the image, reference color images for analysis mechanical arrangement for hosting the image capturing equipment, and test strips; a slot is provided for inserting the strip containing the sample, which is to be tested and having a terminal which is connected to an Image Capture Unit (7),

(D) An Image Capture Unit (7) comprising of a web camera unit capable of capturing
high resolution images of the skin, eyes, ear and throat or any other externally visible
parts of the body of the patient for diagnosis of the related ailments, the unit having a
terminal for being connected to a Computation Unit (19),
(E) An Amplification Unit (8), provided with multiple input terminals, each of which is
connected to one of the above said sensors, and another terminal being the output
terminal and is connected to an Analog Filter Unit (9),
(F) An Analog Filter Unit (9), provided with one terminal connected to the Amplification
Unit (8) for receiving the amplified input analog signal, and another terminal being the
output terminal and provided with a filtered signal to the Digitization Unit (10),
(G) A Digitization Unit (10), provided with one terminal connected to the Analog Filter
Unit (9) for receiving the filtered signal as input and another terminal being the output
terminal for providing a digitized signal to the Microcontroller Unit (11),
(H) A Microcontroller Unit (11), provided with multiple terminals, one of which being the first input terminal, capable of being connected to the Digitization Unit (10) for receiving the digitized signal as input, another terminal being the output terminal, and for providing the data to a Modulating Unit (12), another terminal being the second input terminal, connected to the Demodulating Unit (13) to receive the demodulated signal, and another terminal being the ou^ut terminal and connected to the Mode Selection Unit (14),
(I) A Mode Selection Unit (14), provided with multiple terminals, one of which being the input terminal and connected to the Microcontroller Unit (11), multiple output terminals connected to each of the above said sensors for activating the said sensors and multiple output terminals connected to the LED's in each sensor circuitry for indicating the parameter being measured,

(J) A Modulating Unit (12), provided with one terminal connected to the Microcontroller Unit (11) for receiving the data to be modulated, and another terminal connected to a Wireless Transceiver Unit (15) for providing the modulated signal to the Wireless Transceiver Unit (15),
(K) A Demodulating Unit (13), provided with one terminal connected to the Wireless Transceiver Unit (15) for receiving the modulated signal and another terminal connected to the Microcontroller Unit (11) for providing a demodulated signal,
(L) A Wireless Transceiver Unit (15), provided with multiple terminals, one of which being the first input terminal connected to the Modulating Unit (12) for receiving the modulated signal, another terminal being the second input terminal connected to a second Wireless Transceiver Unit (16) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal being connected to the second Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal which being the second output terminal connected to the Demodulating Unit (13) for providing a modulated signal,
(M) A second Wireless Transceiver Unit (16), provided with multiple terminals, one of which being the first input terminal connected to the second Modulating Unit (18) for receiving the modulated signal, another terminal being the second input terminal connected to the first Wireless Transceiver Unit (15) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal connected to the first Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal being the second output terminal connected to the second Demodulating Unit (17), for providing a modulated signal,
(N) A second Demodulating Unit (17), having one terminal connected to the second Wireless Transceiver Unit (16) to receive the modulated signal and another terminal connected to the Computation Unit (19) to provide the demodulated signal.

(O) A second Modulating Unit (18), having one terminal connected to the Computation Unit (19) to receive the data from the Computation Unit (19), and another terminal connected to the second Wireless Transceiver Unit (16) and provides the modulated signal to the second Wireless Transceiver Unit (16),
(P) A Charging Unit (20), having one terminal connected to the AC mains and another terminal connected to the Electrical Isolation Unit (21),
(Q) An Electrical Isolation Unit (21), having one terminal connected to the Charging Unit
(20) and another terminal connected to the Battery Unit (22) and
(R) A Battery Unit (22), having one terminal connected to the Electrical Isolation Unit
(21) and another terminal connected to all electronic components of the device for
providing power to each of the components.
Sensor for Temperature measurement comprises of a thermistor which when placed in contact with the patient's body, preferably in the armpit, picks up the skin temperature, which then is converted to an electrical signal and is sent to the Amplification Unit. In the presently preferred embodiment, the thermistor has a range of 90*^? to 1 lO^F with an error margin of about +0.1oF
Sensor for Blood Pressure measurement comprises of a cuff. There are two tubes, which come out of the cuff, one of which is connected to a bulb, used to inflate the cuff, and the other one is connected to a pressure transducer, which converts the pressure in the cuff into an electrical signal and sends the signal to an Amplification Unit. Blood Pressure is measured in a semi-automatic and non-invasive fashion, by tying the cuff around the upper arm of the patient. The assembly allows the operator to inflate the cuff manually but the deflation happens automatically at a constant rate. The data, collected by the device is processed by the PC software for calculation of the Blood Pressure and Pulse

Rate. The algorithm uses the periodic pulses created by the pumping of blood through the veins and sensed by the pressure sensor.
Sensor for ECG comprises of four clip electrodes to be connected to the four limbs of the patient and six bulb electrodes to be placed at various pre-specified positions on the chest of the patient. These electrodes are coimected through special cables and coimectors to the Amplification Unit. The leads for each of these electrodes terminates in a small PCB mounted on a circular disc. The disc is arranged such that, the cables can be retracted and stored as a compact bundle.
The electronic stethoscope comprises of a normal stethoscope diaphragm connected by an air column to a transducer, which senses the changes in pressure in the air column caused by the sounds of the heart and lungs, when the stethoscope is placed at various positions on the chest and back of the patient. These sounds are converted to an electrical signal and sent to the Amplification Unit.
The system employs a method for dry-chemistry analysis for blood and urine, using the above device. It captures the image of the test and reference strips and compares the images for closeness of color and intensity determines the closest match by measuring the distance of each of the Red, Green and Blue components in terms of their visual weights displays and stores the result
The blood and urine tests may be carried out by taking a blood or urine sample and putting a small quantity of the sample on a test strip, made up of some enzymes or reagents. The chemical composition of the strip is such that it results in a colour change when the sample is put on the strip. Also, the colour change corresponds to the condition of the patient. The colour of the strip is compared with the colour of the reference strip available either as a chart or in the PC software database
Means for capturing images may comprise of a web camera unit, which is capable of capturing high-resolution images of the skin, eyes, ear and throat or any other externally

visible parts of the body for diagnosis of the related ailments, e.g. rashes on the skin or infection of the eyes or soreness of the throat. Any other mechanism, which allows capture of images, could also be used.
The Amplification Unit may comprise of operational amplifiers and other electronic components, which multiply the input signal with a pre-determined, gain and provide the output signal to the Analog Filter Unit
The Analog Filter Unit may comprise of circuitry to filter out the unwanted frequencies fi"om signals received from each of the sensors. The signal received from the Temperature and Blood Pressure sensors are filtered to separate out the DC components of the signals. Signal received from the ECG sensors is passed through a first order filter with a cut-off frequency of 200 Hz, while the signal received from the Stethoscope sensor is filtered using a sixth order filter with a cut-off frequency of 400 Hz.
The Digitization Unit may comprise of analog to digital converter circuitry, which samples the incoming signals at 8-bit resolution and 960 Hz, which is more than the Nyquist frequency for the signals after they have passed through the Analog Filter Unit.
The Microcontroller Unit may comprise of various standard components, e.g. Arithmetic and Logic Unit, Register Bank etc. It receives the input signal from the Digitization Unit and formats the digitized data to be sent over the wireless link.

The Mode Selection Unit may comprise of electronic circuitry, which enables a particular mode whenever a command is received by the Microcontroller Unit from the Computation Unit over the wireless link. Whenever a particular mode is selected, the LED corresponding to that mode is also switched ON as an indication to the user. As an example of Computation Unit, it may be mentioned that a Personal Computer can be used, though that is not the only way.
The Modulating Unit may comprise of a periodic waveform generator and additional circuitry, which generates a carrier frequency of 460 KHz. This carrier signal is modulated by the signal received from the Microcontroller Unit and sent to the Wireless Transceiver Unit for transmission to the other end.
The Demodulating Unit may have the same circuitry as the Modulating Unit to generate the carrier frequency. The received signal is demodulated using the generated carrier frequency and the demodulated signal is send to the Microcontroller Unit for further processing.
The Wireless Transceiver Unit comprises of transmitter and receiver circuitry to communicate with another Wireless Transceiver Unit. As an example of Wireless Transceiver Unit, it may be mentioned that Infrared LED's can be used for communication though they are not the only means.
A second set of each of Wireless Transceiver Unit, Modulating Unit and Demodulating Unit may be connected to a Computation Unit.
The Charging Unit may comprise of a step-down transformer and additional electronic components to charge the Battery Unit.
The Electrical Isolation Unit (21) may comprise of a switch, which selects one of the two modes of operation. In one position, the Improved Diagnostic Device goes into charging

mode, and the battery is being charged. At this time, the device is not operational and none of the parameters can be measured. In the other position of the switch, the Improved Diagnostic Device goes into operational mode and any of the parameters can be measured. At this time, the path with the AC mains is completely cut-oflf
The Battery Unit (22) may be a rechargeable battery pack. This provides electrical power for about 20 hours of continuous operation after about 4 hours of charging.
The Microcontroller Unit (11) and the rest of the processing and transmission circuitry may be mounted on a flexible or rigid PCB, which may also contain passive components such as resistors and capacitors, a crystal, and connections. The PCB may be connected to a set of connectors providing connections to the various sensors.
DESCRIPTION OF THE SOFTWARE
The software provided as part of the device of the present invention runs on a Computation Unit, in this case a Personal Computer running any Windows operating system. The software has been developed using Visual C~H- and Windows APFs.
The software has also been integrated with independent Video Conferencing software to create a complete solution for a doctor-patient session to be carried out more effectively.
The software solution includes maintenance of medical records for all patients in a central database. This database is maintained on an independent server (which is another Computation Unit) and information is stored in standard formats like HL7. Any of the client Computation Units can make SQL queries to access and store information in the database. Algorithms have been implemented to maintain sanctity and security of the database.
The communication between any two Computation Units uses two channels for communication, a reliable channel for all medical data and a slightly less reliable channel

for all speech and video data. The reliability of the channel for speech and video depends on bandwidth availability.
The software comprises of various signal-processing algorithms to digitally filter and process the data to enhance the signal quality for further processing. Such algorithms include artifact detection and filtering and 50/60 Hz Notch filters for removal of mains noise. It also has algorithms, which perform calibration of the data as well as perform computation of Blood Pressure, Pulse Rate and R-R interval. It also has algorithms to perform comparison of the captured images with reference images to perform biochemistry analysis.
The software connects to the second Wireless Transceiver Unit and through that, to the Improved Diagnostic Device. It also has the ability to detect various conditions like the connectivity with the Improved Diagnostic Device; low battery condition on the device and ECG leads-OFF wherein the leads have not been connected while taking the ECG of the patient. The software uses an ID for each type of the signal being measured to identify which signal is being measured. It also helps in keeping a check on the health of the system by making sure that the device is measuring the parameter that the software has requested.
It also comprises of a front-end graphical user interface (GUI), which has various buttons and screens that enable the user to select the parameter to be measured and start and stop the measurement. The GUI also plots the ECG and Stethoscope signals. The GUI also provides an interface to create new patient records and retrieve information about the existing patient records. The software also provides an interface to store the various measured parameters to the database. The GUI also provides an ability to print the information in the patient record, including the plots for ECG and Stethoscope and the results of various parameter measurements. The software also has the ability to play out the Stethoscope signal on the audio port of the Computation Unit. All the while, the doctor and patient can be connected through a video conferencing link and can see and talk to each other.

The software also provides a standalone mode of operation, wherein the doctor and patient are in the same location. In this case, the video conferencing session is not required but the Computation Unit has to be connected to the database server for storing the freshly taken measurements. Existing measurements in the database can be retrieved for reference, if required.
OPERATION OF THE DEVICE
The POWER switch on the front panel activates the remote diagnostic kit at the remote location. At this stage, the device is operated with a battery pack placed inside the kit. Low battery is indicated by an LED on the front panel, based on which, the user can recharge the batteries.
As shown in Figure 2, the front-end graphical user interface on the Patient End Computation Unit is activated and it establishes communication with the device, as shown in Figure 1 and described above. Successfiil establishment of connection is indicated at the display of the Patient End Computation Unit.
In a preferred embodiment, the communication unit is a wireless modem that receives the data from the patient computation unit. This data is then formatted and modulated appropriately, and sent across the communication channel. This communication unit also receives data across the communication channel from the doctor's location, and sends this across to the patient end computation unit after demodulation. Such data typically is
• The communication between the doctor and the patient/operator,
• Indication of which tests are to be performed on the patient or
• Diagnosis and Prescription
In the presently preferred embodiment, a similar or better communication unit and computation unit exist at the doctor's location, where the data is received via the communication channel by the communication unit, demodulated and sent to the

computation unit for either display, interpretation or storage purposes. In the presently preferred embodiment, the computation unit at the doctor's location could be a Computation Unit with the facility to display, store and perform necessary computation power for interpretive diagnosis.
In the presently preferred embodiment, Graphical User Interface on the Display Unit allows the user to select the parameters to be measured and viewed on the screen. In the present embodiment, only one parameter can be measured at any given time. The transducer corresponding to the physiological parameter being measured must be connected to the kit using the appropriate connector. The electrodes for measuring various physiological parameters should be placed on appropriate parts of the body. The device must have been switched ON and activated using the software at the patient location.
For the parameter to be measured, the doctor has to press the Start button on his User Interface for the respective parameter. The command is sent to the Patient End Computation Unit over the Communication Channel and subsequently to the Improved Diagnostic Device over the Wireless link. This activates the selected parameter and the device starts collecting data from the respective sensor.
To measure temperature, the temperature probe has to be placed under the armpit of the patient. Doctor can then start the measurement by pressing the start button for the temperature. The software starts collecting data from the sensor and continues to collect samples until the temperature reaches a steady state value. All this while, the temperature reading is displayed on both. Patient and Doctor Computation Units.
To measure Blood Pressure, the patient or operator has to tie the Blood Pressure cuff around the upper arm of the patient and close the valve. Once the doctor presses the Start button for Blood Pressure, the patient or operator can start inflating the cuff After a certain threshold has been reached the software prompts the patient or operator to stop inflating. The deflation happens automatically and after the cuff has sufficiently deflated,

the software algorithm calculates the Systolic and Diastolic pressure values as well as the pulse rate of the patient. All three values are displayed on both Patient and Doctor Computation Units.
To measure ECG, the operator has to connect all the leads to appropriate positions on the body of the patient, which are the four limbs and the standard VI through V6 positions on the chest of the patient. Once the doctor presses the Start button for the ECG and selects the lead to be observed, the software starts to plot the ECG for the respective lead. In the present embodiment, the doctor can choose from among the leads individually or capture all leads simultaneously. The signals are captured for a fixed duration and the collection of samples stops, once the data has been captured completely. R-R interval and Pulse rate are also calculated and displayed along with the plot.
To listen to sounds from the chest and back of the patient, the doctor has to press the Start button for the Stethoscope. The operator has to place the Stethoscope on the various positions on the chest and back of the patient, as instructed by the doctor over the Communication Link. There is provision to connect the signals to the audio port at the Patient and Doctor End Computation Units. Typical headphone socket interface is provided for hearing the audio output
To perform Blood Glucose test, the operator has to place a drop of blood on a strip and insert the strip in the slot provided. Once the doctor presses the Start button, the sample is analyzed and the result sent to the software through the device and subsequently to the doctor.
To perform Urine Sample Analysis, the sample is placed on the strip and results in a colour change. This strip is then placed in front of the image capture means, e.g. a web camera. Once the doctor presses the Start button, the image capture means grabs a snapshot and sends it to the Doctor End Computation Unit. The software at both ends performs a comparison with a reference set of images and presents the results to the doctor.

To view images of the skin, eyes, ear, throat or any other parts of the body, the respective part of the body has to be brought in front of the image capture means. The captured image is sent to the doctor who can then perform diagnosis of the condition of the patient.
In a Standalone Mode of operation, it is assumed that the doctor and patient are in the same location. All operations that were performed by the doctor as described above can be done locally for measurement of each of the parameters. The user interface remains the same and only difference is that the commands and data is not sent over the Communication Channel and is handled locally.
In a preferred embodiment, additional data, such as full waveform respiration, motion detection and EEG may also be collected and provided to the device for further processing. Electrical or other characteristics may be used for the analysis of blood and urine. The dry chemistry sensors may be replaced with wet chemistry sensors for the blood and urine tests, along with the appropriate chemical reagents or enzymes. The system may be used for the tests other than blood and urine tests. In that case the same color change or electrical or other characteristics detection mechanism may be used. The system may have the capability to display the additional physiological, biochemistry and image capture analysis and the results. The system may also be provided with means for making references for the biochemistry tests. The arrangement for passing the patient symptoms to the doctor and/or a mechanism for the doctor and the patient to communicate may be provided in one or more forms like text, auditory or video signals over the available communication channel, to aid the diagnosis process. Further, this data can be packaged in various standard formats like HL7 etc.
In further embodiment, the functionality of the Microcontroller Unit (11) and some of the associated circuitry could be implemented in ASIC, using techniques known in the art. The signal conditioning and processing system useful for capturing the signals from the above sensors and equipment for the purpose of one or more of amplification, filtering, and digitization may be arranged in any sequence.

In yet another embodiment, the communication unit and the signal conditioning and processing units may be integrated into one single unit. The system may be provided with automatic diagnostic aid capability (or the interpretation of various conditions of the patient), on the basis of one or more of the parameters captured. In addition, the system may also have the facility of communicating the diagnostic aid (or the interpretation) to the medical practitioner or for storage purposes with a wire line communication. Further the system may also have the facility of communicating the diagnostic aid (or the interpretation) to the medical practitioner or for storage purposes with a wire less communication. Further more the system may be provided with the facility of continuously monitoring one or more of the parameters captured. There may also be a facility of recording the continuously monitored parameters and interpretations
In still another embodiment, the Device and the Computation Unit could communicate with each other using other means of communication and not limited to the wireless communication.
It is to be understood that the present invention may be embodied with other changes, improvements and modifications that may occur to one skilled in the art without departing from the spirit and scope of the invention.
ADVANTAGES OF THE INVENTION
The Device is an integrated solution for the initial diagnosis of a patient located far from the doctor and / or in the diagnostic laboratories.
The Device in addition to the facility of monitoring the physiological parameters also integrates the capability for biochemistry analysis, and visual signal communication in the remote unit.
The Device can be used for personal preventive healthcare purposes at home locations.

The Device provides an excellent medical diagnosis means for rural population because of being able to capture multiple parameters (and not only physiological), and using multiple of text, audio and visual signals simultaneously for the patient-doctor communication.
The Device can be used by relatively untrained (non-medical professionals) at the point of care remote places.

We Claim
1. An Improved Diagnostic Device, which comprises
(A) Sensors for sensing Temperature, Blood Pressure comprising of a cufF having two tubes which come out of the cuff, one of which is connected to a bulb, used to inflate the cuff and the other one is connected to a pressure transducer for converting the pressure in the cuff into an electrical signal for sending the signal to the Amplification Unit, Electro Cardio Graph (ECG) comprising of four clip electrodes capable of being connected to the four limbs of the patient and six bulb electrodes to be placed at various pre-specified positions on the chest of the patient and Electronic Stethoscope comprising of a normal stethoscope diaphragm connected by an air column to a transducer for sensing the changes in pressure in the air column caused by the sounds of the heart and lungs of the patient each said means having a terminal which is capable of being connected or placed in contact with the patient who has to be diagnosed and another terminal capable of being connected to an Amplification Unit (8),
(B) Means (5) for analyzing blood samples provided with a slot for inserting a strip containing the sample which is to be tested and a terminal for being connected to a Microcontroller Unit (11),
(C) Means (6) for analyzing urine samples, comprising image capturing equipment with control over the timing of the capture of the image, reference color images for analysis mechanical arrangement for hosting the image capturing equipment, and test strips; a slot is provided for inserting the strip containing the sample, which is to be tested and having a terminal which is connected to an Image Capture Unit (7),
(D) An Image Capture Unit (7) is a web camera unit capable of capturing high resolution images of the skin, eyes, ear and throat or any other externally visible parts of the body of the patient for diagnosis of the related ailments, the unit having a terminal for being connected to a Computation Unit (19),

(E) An Amplification Unit (8), provided with multiple input teraiinals, each of which is
connected to one of the above said sensors, and another terminal being the output
terminal and is connected to an Analog Filter Unit (9),
(F) An Analog Filter Unit (9), provided with one terminal connected to the Amplification
Unit (8) for receiving the amplified input analog signal, and another terminal being the
output terminal and provided with a filtered signal to the Digitization Unit (10),
(G) A Digitization Unit (10), provided with one terminal connected to the Analog Filter
Unit (9) for receiving the filtered signal as input and another terminal being the output
terminal for providing a digitized signal to the Microcontroller Unit (11),
(H) A Microcontroller Unit (11), provided with multiple terminals, one of which being the first input terminal, capable of being connected to the Digitization Unit (10) for receiving the digitized signal as input, another terminal being the output terminal, and for providing the data to a Modulating Unit (12), another terminal being the second input terminal, connected to the Demodulating Unit (13) to receive the demodulated signal, and another terminal being the output terminal and connected to the Mode Selection Unit (14),
(I) A Mode Selection Unit (14), provided with miiltiple terminals, one of which being the input terminal and connected to the Microcontroller Unit (11), multiple output terminals connected to each of the above said sensors for activating the said sensors and multiple output terminals connected to the LED's in each sensor circuitry for indicating the parameter being measured,
(J) A Modulating Unit (12), provided with one terminal connected to the Microcontroller Unit (11) for receiving the data to be modulated, and another terminal connected to a Wireless Transceiver Unit (15) for providing the modulated signal to the Wireless Transceiver Unit (15),

(K) A Demodulating Unit (13), provided with one terminal connected to the Wireless Transceiver Unit (15) for receiving the modulated signal and another terminal connected to the Microcontroller Unit (11) for providing a demodulated signal,
(L) A Wireless Transceiver Unit (15), provided with multiple terminals, one of which being the first input terminal connected to the Modulating Unit (12) for receiving the modulated signal, another terminal being the second input terminal connected to a second Wireless Transceiver Unit (16) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal connected to the second Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal which being the second output terminal connected to the Demodulating Unit (13) for providing a modulated signal,
(M) A second Wireless Transceiver Unit (16), provided with mxxltiple terminals, one of which being the first input terminal connected to the second Modulating Unit (18) for receiving the modulated signal, another terminal being the second input terminal connected to the first Wireless Transceiver Unit (15) via a wireless link for receiving a modulated signal, another terminal, being the first output terminal being connected to the first Wireless Transceiver Unit (15) via a wireless link for sending a modulated signal, and another terminal being the second output terminal connected to the second Demodulating Unit (17), for providing a modulated signal,
(N) A second Demodulating Unit (17), having one terminal connected to the second Wireless Transceiver Unit (16) to receive the modulated signal and another terminal connected to the Computation Unit (19) to provide the demodulated signal,
(O) A second Modulating Unit (18), having one terminal connected to the Computation Unit (19) to receive the data from the Computation Unit (19), and another terminal connected to the second Wireless Transceiver Unit (16) and provides the modulated signal to the second Wireless Transceiver Unit (16),

(P) A Charging Unit (20), having one terminal connected to the AC mains and another terminal connected to the Electrical Isolation Unit (21),
(Q) An Electrical Isolation Unit (21), having one terminal connected to the Charging Unit
(20) and another terminal connected to the Battery Unit (22) and
(R) A Battery Unit (22), having one terminal connected to the Elertrical Isolation Unit
(21) and another terminal connected to all electronic components of the device for
providing power to each of the components.
2. An improved diagnostic device as claimed in claim 1 wherein the Sensor for Temperature measurement comprises of a thermistor
3. An improved diagnostic device as claimed in claim 2 wherein the thermistor has a range of 90^F to I lOT^ with an error margin of about ±0. IT^
4. An improved diagnostic device as claimed in claims 1 to 3 wherein the Amplification Unit comprises of operational amplifiers and other electronic components, which multiply the input signal with a pre-determined gain and provide the output signal to the Analog Fiher Unit.
5. An improved diagnostic device as claimed in claims 1 to 4 wherein the Analog Filter Unit comprises of circuitry to filter out the unwanted frequencies irom signals received from each of the sensors.
6. An improved diagnostic device as claimed in claims 1 to 5 wherein the Digitization Unit comprises of analog to digital converter circuitry for sampling the incoming signals
7. An improved diagnostic device as claimed in claims 1 to 6 wherein the Microcontroller Unit comprises of various standard components such as Arithmetic and Logic Unit and Register Bank.

8. An improved diagnostic device as claimed in claims 1 to 7 wherein the Mode Selection Unit comprises of electronic circuitry for enabling a particular mode whenever a command is received by the Microcontroller Unit from the Computation Unit over the wireless link.
9. An improved diagnostic device as claimed in claims 1 to 8 wherein the Modulating Unit comprises of a periodic waveform generator and additional circuitry for generating a carrier frequency of 460 KHz.

10. An improved diagnostic device as claimed in claims 1 to 9 wherein the Demodulating Unit has the same circuitry as the Modulating Unit for generating the carrier frequency.
11. An improved diagnostic device as claimed in claims 1 to 10 wherein the Wireless Transceiver Unit comprises of a transmitter and receiver circuitry to communicate with another Wireless Transceiver Unit, through wireless communication, including but not limited to Lifrared Communication.
12. An improved diagnostic device as claimed in claims 1 to 11 wherein the second set of each of Wireless Transceiver Unit, Modulating Unit and Demodulating Unit being connected to a Computation Unit.
13. An improved diagnostic device as claimed in claims 1 to 13 wherein the Charging Unit comprises of a step-down transformer and additional electronic components to charge the Battery Unit.
14. An improved diagnostic device as claimed in claims 1 to 13 wherein the Electrical Isolation Unit (21) comprises of a switch, which selects one of the two modes of operation.

15. An improved diagnostic device as claimed in claims 1 to 14 wherein the Battery Unit
(22) is a rechargeable battery pack, which provides electrical power for about 20 hours of
continuous operation after about 4 hours of charging.
16. An improved diagnostic device as claimed in claims 1 to 15 wherein the
Microcontroller Unit (11) and the rest of the processing and transmission circuitry are
mounted on a flexible or rigid PCB which also contain passive components such as
resistors and capacitors, a crystal, and connections.
17. An improved diagnostic device substantially as herein described with reference to the
Fig 1 to 4 of the drawing accompanying this specification

Documents:

446-che-2003-abstract.pdf

446-che-2003-claims.pdf

446-che-2003-correspondnece-others.pdf

446-che-2003-correspondnece-po.pdf

446-che-2003-description(complete).pdf

446-che-2003-description(provisional).pdf

446-che-2003-drawings.pdf

446-che-2003-form 1.pdf

446-che-2003-form 4.pdf

446-che-2003-form 5.pdf

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Patent Number

229543

Indian Patent Application Number

446/CHE/2003

PG Journal Number

13/2009

Publication Date

27-Mar-2009

Grant Date

18-Feb-2009

Date of Filing

02-Jun-2003

Name of Patentee

NEUROSYNAPTIC COMMUNICATIONS PVT. LTD.

Applicant Address

#6, 29TH MAIN, BTM LAYOUT, II STAGE, BANGALORE 560 076,

Inventors:

#	Inventor's Name	Inventor's Address
1	RAJEEV KUMAR	C/O. NEUROSYNAPTIC COMMUNICATIONS PVT LTD, #6, 29TH MAIN, BTM LAYOUT, II STAGE, BANGALORE 560 076,
2	AJAY MOON	C/O. NEUROSYNAPTIC COMMUNICATIONS PVT LTD, #6, 29TH MAIN, BTM LAYOUT, II STAGE, BANGALORE 560 076,
3	SAMEER SAWARKAR	C/O. NEUROSYNAPTIC COMMUNICATIONS PVT LTD, #6, 29TH MAIN, BTM LAYOUT, II STAGE, BANGALORE 560 076,

PCT International Classification Number

G01F31/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA