DE102008037919A1 - Method for potential-free detection and evaluation of measurement value for determining and/or monitoring vital function of human, involves wirelessly transmitting processed measurement signals from carrier element to signal evaluation unit - Google Patents

Abstract

The method involves associating electrodes, measuring elements or sensors, an electrical power source and electronics for processing and transmitting measurement values with a flexible carrier element (1). The carrier element is applied and bonded at a body of a to-be-tested person, for continuity of measured value acquisition. Processed measurement signals are wirelessly transmitted from the carrier element to a signal evaluation unit and/or a display. A load-independent continuous current is induced in an area of skin surface by current electrodes. An independent claim is also included for a device for potential-free detection and evaluation of a measurement value for determining and/or monitoring a vital function of a human.

Description

Field of the Invention / Summary

The Invention relates to a device ("Smart Vital Sensor") and a method ("Smart Vital Expert") for detection and monitoring vital signs in humans.

It is the "Smart Vital Sensor" to a Medical device can be used in a medical emergency, in the clinic, in the doctor's office, in the palliative medicine as well as outpatient in domestic Environment or traveling. As recorded reactions of the vegetative become, the device is also suitable for detecting emotions in the context of behavioral science. The system can also be used in veterinary medicine be used.

The "Smart Vital Sensor" communicates via an interface for wireless data transmission with a satellite computer z. B. a laptop (see 1 ). The wireless data transmission also allows the location of the patient or subject or the biological object, which in both the field of "home care" as well as in behavioral research z. B. can be used in the capture of shopping behavior in a supermarket.

"Smart Vital Expert "is the associated program package with program modules for the microprocessors in the "Smart Vital Sensor "as well as modules for the corresponding one Satellite computer. The corresponding modules control the transducers, Decrypt the data stream, convert the primary data in physiological parameters, check on plausibility, calculate the physiological values in the "time" and "frequency domain" and correspond with database systems for storing the values.

"Smart Vital Expert "analyzes the data of the" Smart Vital Sensor "for prognosis, prevention, Therapy, pharmaceutical and behavioral research.

background

Intensive medical monitoring

The Process, structure and result quality in the preventive, Intensive care and palliative medicine as well as behavioral science in transition and increasingly requires more extensive use of networked information. The simultaneous acquisition of several signals and the resulting plausibility check with as a result improved sensitivity and specificity Diagnostics is an important step in this direction.

The strategic objective of technical development for the detection of biological Operations are increasingly becoming non-invasive measurement be there for invasive monitoring of a parameter Any way body tissue has to be injured, for example Example through puncture openings of catheters, which in Blood vessels or other fluid-filled Cavities of the body are introduced. An invasive procedure always involves a certain risk z. B the risk of infection or bleeding.

Basic Non-invasive monitoring methods for vital data acquisition deal with the monitoring of the cardiovascular and the respiratory system as well as the state of consciousness. Since it is at the derivative ECG, blood pressure monitoring, body temperature and the oxygen saturation of the blood by non-invasive There are hardly any patients in an intensive care unit, where these measurements are not made.

something similar applies to a monitoring of older, infirm and terminal sufferers, despite limited body functions want to stay in their own home environment.

Of the Ambulance is used in accidents and emergencies, where it is determined that the condition of a patient is life-threatening or the condition could become threatening. The ambulance works in advance of the intensive care unit. Intensive medical monitoring is indicated in the case of severely injured, serious illness or States after big and strong intervening Operations.

Terminal diseases, such as terminal cancer, do not result in admission to an intensive care unit. Palliative medicine is established in this field. But in palliative care, vital signs are also needed to relieve pain caused by elemental disorders such as: B. by a To avoid fluid deficit.

Of the Condition and the state of consciousness of the seriously ill can change very fast rapidly. To assess the state of consciousness As a rule, reliable technical ones are still missing today Aids of high sensitivity and specificity. The corresponding monitoring takes place today according to recognized and standardized verbal stadiums and state classifications with high personnel costs. It will become more and more successive in the future be supplemented by intelligent systems.

Circulatory monitoring is predominantly based on the following simultaneously registered signals of cardiac activity: description abbreviation source - electrocardiogram ECG body tension - Balistocardiogram BKG acceleration - Impedance cardiogram ICG bioimpedance - phonocardiogram PKG acceleration - Skin Pulse curve DKG light absorption

Pulmonary function monitoring is predominantly based on the following simultaneously registered signals of respiratory activity: description abbreviation source - arterial oxygen saturation S _a O ₂ light absorption - venous oxygen saturation S _v O ₂ light absorption - Respiratory rate f _breath bioimpedance - tidal volume AZV bioimpedance - skin temperature T _skin PT 1000

The monitoring for assessing the body condition is based inter alia on: description source - Heart status see circulatory monitoring - Status lung see lung function monitoring - Status of voluntary musculature second BIOSENSOR z. B. thighs - Status posture and walking acceleration - Status of fluid homeostasis (blood volume) bioimpedance

The monitoring of the state of consciousness is supported by the following simultaneously registered signals of the anti-gravitation musculature, the skin circulation and the language: description abbreviation source - body position acceleration - electromyography EMG _leg body tension - spontaneous movements acceleration - Speech dialogue acceleration - emotional reflexes of skin circulation light absorption - Heart rate change while speaking MR ECG

Procedures of non-invasive diagnostics

Today common procedures to derive body signals non-invasively, are shown below. Here are considered:
electrical body tensions
change of position
Structure-borne noise (auscultation)
light absorption
temperature
Frequency dependence of the electrical resistance (bioimpedance) as well as rapid changes of the electrical resistance (first derivative)
Links between the signals

Signal source body voltage

From contracting muscles can be electrical voltages (action potentials) derive on the skin surface. In general, the measures Electromyography (EMG) the sum action potential of a whole Muscle or even multiple muscles. The EMG is in human medicine used in neurological diagnostics. For the rhythmic The contracting heart becomes tension as an electrocardiogram (ECG). Movements of the voluntary musculature as well Changes in the heart rate triggered z. B. Linguistic communication with a patient provides information the awareness status or the depth of a coma.

Body position and movement

The Body position, the frequency of spontaneous movements and the reaction patterns of skin perfusion after linguistic communication with a patient provide information about the status of consciousness or the depth of a coma.

auscultation

Under Auscultation is understood in medicine as listening to Structure-borne noise, typically with the stethoscope. sound waves are longitudinal waves and can be used with acceleration sensors be recorded. The auscultation of structure-borne sound serves Assessment and evaluation of heart, lung, intestinal and joint noises.

light absorption

The characteristic red color of the blood is due to the high attenuation short-wavelength blue light and relatively low absorption of the red / infrared light in the blood. The color of the blood is also dependent on the oxygenated and non-oxygenated Condition of hemoglobin. These wavelength-dependent Characteristic can be used to determine the oxygen saturation of the red blood dye. At the wavelength of 805 nm there is no dependence of the absorption on the oxygen content.

oxygen saturation

The Oxygen saturation indicates the percentage of hemoglobin in the blood is saturated with oxygen. The determination of Oxygen saturation allows, among other things, statements about the effectiveness of oxygen transport, so in the first place Line about breathing. The oxygen saturation can be either directly in a blood sample or non-invasively by means of Pulse oxymeter can be determined. The photometric method of oximetry lies based on both methods.

The higher the oxygen partial pressure in the blood, the higher the oxygen saturation. The relationship is non-linear because the oxygen affinity of hemoglobin depends on the number of O ₂ molecules already bound. The oxygen binding curve shows an S-shaped course.

Arterial oxygen saturation (S _a O ₂ ) is an important parameter for assessing respiratory function. It allows conclusions about the function and activity of the lungs. Depending on the clinical picture and age of the patient different arterial saturation values apply. For healthy children and young adults applies Values close to 100%, in older people or certain illnesses also values are sufficient by 90%.

In addition to determination in arterial blood, oxygen saturation is also measured in the venous blood (S _v O ₂ ) of various stromal areas. From the difference to the arterial saturation, the oxygen uptake of the respective tissue is estimated together with the blood flow. If one knows the oxygen consumption, an increase of the difference indicates a decrease of the blood circulation. Thus, information about the state of O ₂ supply can be obtained in individual organs.

Peripheral oxygen saturation is needed to calculate the clinically increasing oxygen concentration (C _a O ₂ ).

In intensive care practice, above all, mixed venous saturation is important because it provides information about the cardiac output. To a good approximation, the easy-to-measure central venous saturation (S _zv O ₂ ) fulfills the same purpose.

Emotional reflexes of skin circulation

changes the skin circulation triggered z. B. by linguistic Communication of a patient provides information about the status of consciousness or the depth of a coma.

temperature

The Skin temperature is a vital parameter. The temperature is u. a. used for the correct determination of oxygen saturation.

Bioelectrical impedance

The Determination of Bioelectrical Impedance (BIA) is a procedure in life size and scope of functional cell groups like muscle mass and storage fat by means of alternating electrical voltages to determine. The principles of bioelectrical impedance analysis to measure and calculate body composition already described in the US in the 1940s. Scientifically developed The method then became the 60s and 70s of the last century by Hoffer, Jenin and Lukaski.

today BIA is a recognized, easy to use, non-invasive and last but not least inexpensive measuring method with a wide range of applications in diagnostics, prevention and therapy.

The Method uses the different electrical conductivity of lung tissue, bones, muscles and body fat. By their well-defined electrolyte content are cell fluid and intercellular fluid for the electrical Current conductor second class, their resistance to the liquid volume is inversely proportional. Fat is to be characterized as a nonconductor. Thus, the lipoprotein layer in the membrane of each cell acts as Isolator and trains capacities.

For the BIA are measured for impedance, vector-graphically combine the partial resistances with active and reactive resistance. The partial resistances (resistance and reactance, or and reactance) are on the one hand dependent on the length (or geometry) of the body portion, the volume of Body fluids in the intracellular and extracellular Distribution spaces (effective resistance) and on the other hand of the capacities of the body cell membranes (capacitor effect the lipoprotein layer, reactance).

Out the measured resistances (active and reactance) is taking into account the patient data, such as size, Weight, gender and age, using algorithms, the cell volume and the volume of intercellular fluid of each Body section calculated. The measurement and documentation of changes in body composition we you. a. for fluid balance, early detection of malnutrition and exercise control in sports as well used in weight reduction programs. Fast changes impedance correlate with body fluid shifts, the heart-synchronous changes with the stroke volume or Blood pulse.

Older formulas (multiple regression equations from studies using comparatively analyzed reference methods) show a very wide range with regard to the absolute volume values and take into account dynamic processes only conditionally.

Become the values but z. B. on the current weight or on the outside Volume of the respective body section, can over the change of conductivity (primarily the resistance or the resistance) of the body fluid content be measured with sufficient accuracy.

impedance cardiogram

The Impedance cardiogram (IKG) is a special case of bioelectric Impedance. Heartbeat-synchronous, fast changes the impedance at the thorax, z. B. measured at 60 kHz are conditioned by the pumping function of the heart. The amplitude of the rash correlates with the stroke volume of the heart.

The Impedance cardiography is the only noninvasive method that continuous insight into the central hemodynamics of a living being. It allows the determination a comprehensive hemodynamic status as it provides information about the fluid balance (eg blood flow in the large central Vessels, venous blood volume shifts, Alignment of corpuscular blood elements), cardiac performance, providing the preload and afterload on the heart.

Pulse Wave Velocity

The Heartbeat ejected from the heart triggers a pulse wave out, leading to the terminal branches of the arterial vessels can be tracked. The speed of the pulse wave hangs from the wall tension of the arterial vessels. As the blood pressure rises, so does the wall tension. Because the track, which traverses the pulse wave through which fixed on the skin BIOSENSOR remains constant, is the changes of the pulse wave transit time z. B. measured on the basis of the time shift of the pulse wave between impedance cardiogram (IKG) and skin pulse curve (DKG), vice versa proportional to blood pressure changes.

The thus determined values, which redefines from heart beat to heart beat are an example of determining an important physiological additional size, which in the individual IKG and DKG signals used to determine the pulse wave transit time are not included.

signal links

The Stroke volume (SV) is the most important parameter of the pumping function of the heart and it is extremely important this size reliably determine. By linking from PKG and IKG will increase the sensitivity and specificity the stroke volume determination increased. In Hegglin syndrome leads even the exact ones result from the combination of ECG and PKG Diagnosis.

Out the multiplicative link between stroke volume and blood pressure the heart work results. From the multiplicative link The cardiac output is calculated from stroke volume and heart rate.

Becomes the blood pressure divided by the cardiac output, the results Total peripheral resistance (TPR) one of the most important circulatory variables. The total peripheral resistance represents the sum of all flow resistances in the great circulation through which the left ventricle of the heart has to pump the blood. A variety of the circulatory Pharmaceuticals influence this flow resistance or at least Parts of it.

When an example from the frequency domain here is the heart rate variability called, the information about the state of the vegetative Nervous system (parasympathetic activity).

Nursing access to intensive care patients

Lots Medicines used in intensive care must be over electronically controlled drug pumps (syringe pump) directly be administered intravenously, often four to ten such devices are placed next to the patient bed. In addition, many patients are mechanically ventilated, which is why often Respirators stand next to the patient bed. some Patient also needs a dialysis machine. All Equipment must be in the immediate vicinity of the patient can be set up. With all these devices it is advantageous if as little as possible on cabling hinders the nursing access to the patient.

Home Care

in the Contrast to intensive care where monitoring of vital signs is absolutely necessary, is also in the domestic environment Vital data monitoring increasingly used to help lonely elders or frail with limitations of body functions to save the transfer to a home or clinic.

Detailed description of the invention

With the BIOSENSOR will be electrocardiogram, body position, movement and Herzschall, breathing depth and respiratory rate, oxygen saturation and temperature, fluid content, blood flow and cardiac output, as well as the pulse wave transit time an estimate for acute changes in blood pressure won and transmitted wirelessly to a satellite computer.

For this purpose, signal generators for the determination of electrical body voltages, accelerations in three axes, the backscatter of light, the skin temperature and the electrical impedance of the over-adhered body portion are summarized on a flexible substrate. Acceleration sensors determine body position, movements, auscultate the heart sound and measure the heart-top impact. LEDs are used to couple light and measure the absorption of the backscattered light. A PT 1000 temperature sensor measures the skin temperature. The block structure shows 1 ,

When Carrier material is a foam used on the with the help of thick-film technology - but also with others Method - electronic components introduced or being constructed. With gel material and silver-silver chloride transitions becomes the surface of the skin with electronic elements or with prefabricated electronic components or also connected thermally conductive.

For the detection of position, movement and sound contains the Carrier an array of acceleration sensors. There is it in the carrier material for breakthroughs for Sound. Light is emitted via LEDs and via photosensitive Diodes detected. There are in the carrier material translucent routes for red and infrared Light. This creates a highly integrated product in the smallest of spaces on a flexible carrier.

On The carrier also has modules for monitoring the technical function, control of the signal converter, signal processing for pattern recognition and plausibility check the signals and a module for wireless transmission of Dates.

A Data storage unit collects the information up to a few minutes, in case of disturbances of the transmission path information losses to avoid. The associated data storage will also used for the encryption of the data.

One bendable, flexible power module provides the functions for safe for up to 48 hours.

Flexible carrier

The flexible carrier unites all signal converters contained in the BIOSENSOR. The signal transducers simultaneously pick up the signals from the skin surface (see 2 ). The substrate of the BIOSENSOR is a foam similar to stick-on ECG adhesive electrodes. The dimensions of this carrier are: width about 1 to 10 cm; Length 10 to 50 cm; Height 0.5 to 2 cm (see 3 ). On the side, which can be glued to the skin, there is a skin-friendly adhesive over a large area. Only the skin-facing contact surfaces for the transmission of heat, sound, light, electricity and voltage are recessed. The foam shields the transducers against interfering sources from the environment. It insulates against heat, sound, light, electricity and voltage.

body tension

The metallic surfaces serve to produce electrically conductive connections to the skin. They are embedded in the foam. On the skin-facing side of these metallic surfaces are NaCl-containing gel deposits. As electrically conductive but poorly thermally conductive connection between this gel and the first electronic component is a Titanbearse (see 4 ). These electrodes also absorb the voltages for the bioelectrical impedance.

auscultation

about From the foam recessed openings becomes structure-borne sound auscultation. The direction can be cleared by the signals of the Arrays of accelerometers with each other on the sound source (z. B. the beating heart) are aligned. The sound detection auscultation thus has a controllable directional characteristic for their greatest sensitivity.

Movement and body position

to Detection of body position as well as movements are also the signals of the acceleration sensors used.

light absorption

about embedded in the foam light-emitting diodes (LEDs) becomes red and infrared light of discrete wavelengths (Range 680-805 nm) fed into the tissue. The light is scattered and absorbed on the cells in the blood. The backscattered portion of the light is at the BIOSENSOR to determine the skin pulse curve and to determine the oxygen content used in the blood. This is the different absorption behavior between reduced and oxygenated hemoglobin in the blood used. For referencing for hematocrit becomes an LED with the isosbestic wavelength of 805nm (Infrared) narrowband operated. Two more LEDs are included 680 and 755 nm narrowband operated. The LEDs are concentric arranged to the receiver so that the transmitter-receiver distance is the same for all emitted wavelengths. The three LEDs are sequentially each about 10 microseconds long driven. Then follows a break of approx. 700 μsec. The relatively long waiting time of 700 μs between the last pulse the sequence and the start of the new sequence is chosen so that the intensity of the LEDs for a short time very much can be chosen high without overloading their life is reduced.

The Absorption of the light of the two LEDs with the shorter ones Wavelengths are both of the degree of oxygenation and strongly dependent on hematocrit. The wavelength in the infrared region at 805 nm, at which no absorption change is detectable with variation of the oxygen content becomes Determination of local hematocrit used. At known Hematocrit is then about the absorption of light the two LEDs with the shorter wavelengths the arterial and venous oxygenation degree is calculated. All optical and electrical components are in the substrate integrated and sealed against ingress of liquids.

temperature

The Skin temperature is via a embedded in the foam the skin directly overlying temperature-sensitive PT 1000 sensor measured.

Bioelectrical impedance

For the bioelectrical impedance, electrical alternating current (I _~ <0.7 mA) of different frequencies (eg seven) from the range of 1 kHz to 4 MHz is fed into the body via the two current electrodes. Via the internal electrodes, which lie between the feed electrodes, the voltage drop (impedance) and the phase shift of the signal voltage are measured at each frequency for the respective body section, thus determining the reactive and reactive resistances of the body section.

The Software from BIOEXPERT guides the necessary correlation factors for bioelectrical impedance analysis of age, gender, Weight and size as well as the phenotype of the patient from tables stored in the ROM, or requested the necessary additional values at the necessary intervals.

By the detected impedance is shown in the resistance diagram calculated a curve. By extrapolation, the two intersections become of the curve with the X-axis determined. The determined two resistances, those with changes in body fluids in the intracellular and extracellular distribution space, are associated with patient-related correlation factors in fluid volumes converted.

resistance change

The first derivative of the voltage drop across the complex resistor (impedance the frequency near 60 kHz) of the internal electrodes Body section is over a low-noise, narrowband, differential input amplifier tapped, located just behind the impedance transformer of the internal electrodes located.

blood pressure

From Beat to beat can be over the pulse wave transit time between the first derivative of chest impedance (IKG) and the skin pulse curve be concluded on changes in blood pressure. The change of Runtime between the signal of the first derivative of the thorax impedance and the optical signal for determining the backscatter from the skin, is for correlation to changes of the arterial blood pressure when glued on only one BIOSENSOR is. If another BIOSENSOR is active parallel to the first, can with the evaluation of further pulse waves the sensitivity and specificity of the changes of the arterial Blood pressure can be increased. When absolute blood pressure should be recorded, the values once sphygmomanometertrisch be calibrated. This calibration must be in larger Distances z. B. be repeated once every 24 hours.

Application location of the first BIOSENSOR

When Place for the application of the first BIOSENSORs is the Skin region selected left lateral to the thorax under the upper arm become. This position is optimal for ECG, ICG and cardiac sound and also provides adequate protection against mechanical damage (Tear off) the BIOSENSOR.

fault poverty

A extensive lack of interference in the determination of all signals This ensures that the susceptibility towards electromagnetic, optical and acoustic Interference fields is reduced to the bare minimum, since Wiring distances and running distances for Herzschall and Backscatter goes to zero and thus disturbing influences of electromagnetic interference (humid scattering), Noise and extraneous light almost completely be prevented.

Of Furthermore, a low-noise determination of all signals also by ensuring that by applying extremely Narrow band, analog filter in the input of each parasitic signal Noise components are eliminated.

signal processing

All Signals are sent directly in the BIOSENSOR by program part program part programs BIOEXPERT is processed and checked for plausibility.

By Analysis of the basic data as well as the temporal allocation of all signal sources with each other further calculations of cycle characteristics such as stroke volume, stroke work, cardiac output, cardiac output, Oxygen consumption and the calculation of total peripheral resistance and more determined. Furthermore, FFT (Fast Fourier Transform) analyzes the frequency domain of the ECG, IKG and respiration and u. a. determines the heart rate variability.

The The data is displayed on a satellite computer, a laptop or fixed PC.

part programs of the program package BIOEXPERT on the satellite computer for status messages between technical errors of the BIOSENSOR and pathophysiological deviations of the signals from the norm. Technical malfunctions are immediately considered as maintenance instructions further reported. The software recognizes via ROM Signal pattern of ECG, ICG and respiratory somatic peculiarities of respective signals. The BIOEXPERT program reports suspected diagnoses when the pattern characteristics of the physiological Remove signals from the standard.

Spontaneous movements and changes in the skin's circulation due to emotional reactions are determined via the available signal sources, which among other things allow to detect changes in position and speech. This is used to estimate the patient's state of consciousness. BIOEXPERT takes into account confirms the condition of reduced specificity in the diagnostic evaluation. Pathophysiological deviations are only reported immediately if the plausibility check has excluded technical errors.

energy storage

For the provision and storage of energy become flexible, the body shape adaptive accumulators used. In addition, energy from body movements and Temperature differences used to increase the useful life of the BIOSENSOR to extend.

succession

Becomes another BIOSENSOR z. B. applied to the leg and over a synchronization cable that simply push buttons can be connected, coupled, can be regional Differences z. B. the blood supply and the liquid content and / or the activity of the voluntary musculature become.

data transfer

template for electrocardiogram, body position, movement, Apex of the heart, heart sound, respiration and oxygen saturation, Skin temperature, blood flow, fluid content, an estimate for acute changes in blood pressure as well as the calculated from the signals data are transmitted. The transmission of the data takes place continuously on wireless Ways. Short failures of transmission in the area Up to a few minutes are bridged by a buffer.

The Information that is transmitted is encrypted and sent with the time offset of two heartbeats.

satellite computer

With The program package BIOEXPERT can be run on a satellite computer at the same time the signals of at least 20 people were recorded, be displayed and saved.

about the use of the option of remote transmission of the physiological Signals to the Internet and by evaluation of the signals by trained Personnel (telemedicine) will further reduce the error rate.

application

The highly integrated product is as multifunctional electrode (BIOSENSOR) intended for application on the skin. The BIOSENSOR starts immediately after attaching the vital data wirelessly to a satellite computer, to transfer a laptop or a fixed PC.

Of the preparatory effort is minimal. The tearing the packaging activates the power module and the BIOSENSOR starts to send.

On weakly haired skin, the BIOSENSOR immediately after easier Degreasing be glued with an alcohol swab. For a correct function must be an electrically conductive connection to the skin, the penetration of test light into the skin and the derivation of structure-borne noise from the skin is sufficient be possible undamped. When to stick the Electrode the hair at the appropriate place by shaving away The BIOSENSOR is also suitable for examinations on the animal.

Of the BIOSENSOR is intended for long-term observation because of the flexible Carrier due to its low height and flexibility on the skin does not bother. The glued BIOSENSOR triggers barely suprathreshold tactile skin stimuli. Also remembers no wiring constantly to its presence.

Of the BIOSENSOR is suitable for capturing and monitoring of Elementary disorders such as respiratory disorders (u. a. Lung failure, respiratory failure, pulmonary embolism, Pulmonary edema), severe electrolyte disturbances or Disorders of body fluid homeostasis, Disorders of hemostasis (blood clotting), shock (These include anaphylactic shock, hypovolemic Shock, neurogenic shock, cardiogenic shock, septic shock) and dangerous cardiac dysfunctions such as cardiac arrhythmias (Arrhythmia).

One Special case is the Hegglin syndrome, a special case of energetic-dynamic Heart failure, where metabolic disorders of the heart muscle affect the process of muscle fiber contraction. Hegglin syndrome is found on the ECG as an expression of an arousal disorder a prolonged QT interval with relative shortening the mechanical systole duration. Clinically, the syndrome is only at simultaneous registration of ECG and cardiac sound (PKG). Hegglin syndrome occurs when the second heart sound is more than 0.02 seconds before the end of the T wave in the ECG.

Next Continuous monitoring with alarm forwarding Monitoring with the BIOSENSOR also allows extensive standardization the measurement, because subjective errors and technical faults be largely excluded. In addition, the software package offers BIOEXPERT interfaces via which the measured values are forwarded and automatically z. B. documented in a patient data management system can be.

State of the art

As generally known, the following techniques and methods are adopted:
Skin-friendly adhesives, low-allergen foamed plastics, methods of applying metallic layers and semiconductors to flexible substrates and forming by etching, as well as the technology of microprocessors and the wireless transmission of data.

Regarding the energy storage is running, which stand flexible Energy storage achieved in 2008.

Non-invasive detectable body signals

Currently be different body signals such as ECG, heart sound, Pulse wave etc. on each separate devices taken from the skin surface, displayed and evaluated. However, the individual signals are very susceptible to interference. Become several independent signals simultaneously Tapped, the specificity and sensitivity the derived diagnostics in such networked taps of several Signals improved by orders of magnitude.

nowadays allow the devices used because of their size and the size of the signal converter only a consecutive Commitment. With every extra attached on the skin Sensor will give the patient a higher level of cooperation required. In addition, by the additional wiring the mobility of the patient more and more restricted. Reduce cabling and patient collaboration requirements but the compliance of non-invasive diagnostics drastically. A corresponding Cooperation of the test object or a patient is currently only guaranteed under laboratory conditions and only left here the advantages of networking multiple signal sources safe use.

Long-term ECG monitoring

One Long-term ECG is used today by electrodes taped to the chest continuously transferred to a cassette or memory recorder, which is worn on the belt or around the neck. The older similar to analog recording tape cassette devices a walkman and weigh about 150-220 grams. Modern devices Store digitally on hard drives, memory cards or comparable Storage media. They weigh about 100-120 grams and allow a recording time of up to one week. After the end of the recording the data are evaluated computer-aided, whereby average About 100,000 heart actions per 24 hours are detected and analyzed Need to become.

Cardiac short-term event

For Short-term events, there are small digital recording devices the size of a folding phone, that of the patient can be carried. When symptoms occur like palpitations or heart stumbling, the patient pushes that Device on the skin in the chest area and so can do an ECG recording over trigger a few minutes. Also for short-term events There is long-term memory, the ECG signals via skin electrodes record permanently. Delete these transmission systems the record but usually after a minute again. Only preprogrammed special ECG events and marked by the patient by pressing a button ECG episodes are stored permanently.

Since about the turn of the millennium, new recording and transmission techniques are available, which have further improved the possibilities for recording and therapy of even very rare arrhythmias.

implantable Recorders can record ECG episodes over several years without significant patient impairment, the query of these recorders takes place wirelessly. The devices itself and the risk of surgical implantation are with those comparable to pacemaker therapy. They fall under the concept of invasive diagnostics.

Specific Cell phones with ECG electrodes can be placed on the chest wall and send a current ECG to an emergency center. In front and after ECG transmission can be over the usual intercommunication query symptoms and therapeutic advice convey. If necessary, the whereabouts of the patient can be determined and a rescue mission will be triggered.

acceleration

to Sound detection for speech and structure-borne sound as well to capture body position and movement are miniaturized Acceleration sensors used. In recent years have miniaturized Acceleration sensors have become increasingly important. There are micro-electro-mechanical systems (MEMS). You will u. a. made of silicon produced. These sensors are spring-mass systems in which the "feathers" only a few micro-millimeters wide Are webs and the mass z. B. is made of silicon. By the Deflection in acceleration or sound can be sprung between the suspended part and a fixed reference electrode a change the electrical capacity to be measured. The whole Measuring range covers a capacity change of only about 1 pF. Therefore, the electronics for the evaluation of this small capacity change right on the same Semiconductor device to be integrated.

For The manufacture of these sensors will be the mass and the small ones Springs z. B. etched by means of photolithography from the ground substance. In order to obtain a self-supporting structure, an underlying one becomes Layer also removed by etching.

These Acceleration sensors have the advantage of relatively low unit costs and high reliability. Due to the small size They are also characterized by their high measuring speed. The frequency response ranges from 0 Hz to the kHz range. It can thus movements, Detecting structure-borne noise and speech. Because of their reliability they are z. B. used to trigger airbags in vehicles.

auscultation

The Accelerometers are also used for auscultation as well as for the impulse measurement of the Herzspitzenstoßes used.

light absorption

In 1987, Takatani filed a patent for an optical sensor with LEDs for non-invasive determination of oxygen saturation [patent no. JP62251662A , Takatani 1987].

The transmitting diodes used in this device belong to the group of super bright LEDs in order to be able to transmit a high light intensity in skin and blood. (Example Super Bright LEDs, Inc St. Louis, Missouri, USA; www.superbrightleds.com The intensity of the reflected light of the three LEDs is detected via a PIN photodiode.

in the Compared to inorganic light-emitting diodes can be organic Light-emitting diodes (OLED) cost-effective and for each Create wavelength. Your limited lifespan is playing for a service life of less than 50 hrs. No matter.

OLEDs and PIN photodiodes are components of microelectronics used in various embodiments commercially available are.

Parts of the above are the Federal Standard 1037C taken from. The "Glossary of Telecommunication Terms" is a US standard issued by the General Services Administration. The standard was revised in 2001 by "American National Standard T1.523-2001, Telecom Glossary 2000" , Of the Standard is published by Alliance for Telecommunications Industry Solutions (ATIS).

temperature

For temperature measurement, the electrical resistance change of a platinum layer is used. The platinum temperature sensors are characterized by their nominal resistance R ₀ at a temperature of 0 ° C. Pt 1000 (R ₀ = 1 kΩ) is used. The characteristic of the resistance change is in DIN IEC 60751 established.

The Platinum is meandering in the thin-film process applied to a support. After bonding the connecting wires and the adjustment of the nominal resistance by laser trimming is the Platinum layer provided with a coating to protect against chemical To protect influences.

impedance

For the body impedance becomes a low but constant alternating current two current electrodes fed into the body section and over two internal electrodes are the voltage change tapped on the body section. This z. B. a Section of the thorax into a constant alternating field of high frequency brought. Voltage changes across the internal electrodes be tapped, correspond to changes in impedance in the Circuit during the cardiac cycle and breathing. The impedance changes, in turn, are the result of volume shifts, in the cardiac cycle with the stroke volume of the heart and at respiration with the tidal volume.

microprocessor

A variety of power-saving microcontrollers are on the market that consume less than 1 mA in the operating state. Example: Low-current microcontroller ATAR080 from Atmel Corporation 2325 Orchard Parkway San Jose, CA 95131; USA www.atmel.com/literature , The microcontroller contains among other things RAM, ROM, A / D converter etc. and sensors, which report the respective functional condition.

data encryption

Wi-Fi Protected Access ^TM- 2 (WPA2) and Wi-Fi Multimedia are examples of tomorrow's encryption technology.

WIRELESS INTERNET ACCESS

The "Power chip" AWL6951 is mentioned here as an example. It is sold by ANADIGICS, Inc. 141 Mount Bethel Road Warren, 07059 New Jersey, USA. www.anadigics.com ,

He is 4 × 4 × 1.3 mm and he consumes about 200 mA when sending. Its data rate is 56 Mbps and the range in buildings is bigger than 20 m. At a transfer rate of less than 50 kbps as with the BIOSENSOR is its transmission frequency only 1 per thousand.

energy storage

paper Thin Flexible rechargeable batteries store about 100 mAh at one Voltage of 0.8 V. (Photocrosslinked nitroxide polymer cathode-active materials for application in an organic-based paper battery; Takeo Suga, Hirnaki Konishi and Hiroyuki Nishide).

A corresponding article was first published as "Advance Article" on WEB on February 12, 2007 , For a requirement of 2 Ah at 3.2 V, approximately 80 g are calculated for such a battery.

1 : Block diagram and overview of the modules in the "Smart Vital Sensor" and the satellite computer (laptop)

• ( 1 ) Carrier with sensors; ( 2 ) Laptop (satellite computer) for display and data storage; ( 3 ) further computers in the network for expert system and archiving

The source code for the microprocessors 1 to n for controlling the primary converter and the softwa re for display and evaluation on the satellite computer (laptop) form together with the respective signal transducers the control method and evaluation method and "Smart Vital Expert"

2 : Block diagram of the flexible carrier;

• ( 1 ) Current electrodes; ( 2 ) Internal electrodes; ( 3 ) flexible carrier; ( 4 ) Peltier current regulator; ( 5 ) ECG low frequency amplifier; ( 6 ) ECG mid-frequency amplifier; ( 7 ) Acceleration sensor array; ( 8th ) Amplifier; ( 9 ) LED function display; ( 10 ) LED array; ( 11 ) LED amplifier; ( 12 ) Light receiver sensor (PIN diode); ( 13 ) Temperature sensor; ( 14 ) WLAN transmitter module; ( 15 ) Antenna; ( 16 ) Impedance amplifier for frequencies 1 to 7; ( 17 ) Differentiating amplifier; ( 18 ) Phase detector for frequencies 1 to 7; ( 19 ) Frequency generator; ( 20 ) active shielding; ( 21 ) Push button; ( 22 ) Microprocessor MP 1 to MP n

3 : Dimensions and views of the flexible beam;

• ( 1 ) Current electrodes; ( 2 ) Internal electrodes; ( 3 ) flexible carrier; ( 7 ) Sound openings for accelerometer array; ( 8th ) Amplifier; ( 9 ) LED function display; ( 10 ) LED array; ( 12 ) Glass feedthrough for light receiver sensor; ( 13 ) Temperature sensor; ( 20 ) Shielding; ( 21 ) Push button; ( 23 ) Battery

4 : Cooling principle of the respective first amplifier element;
upper part of the figure: cooled voltage tap for impedance input amplifier
lower: Part of the figure: Glass light lock for cooled PIN diode

• ( 1 ) Current electrode; ( 2 ) Internal electrode (part); ( 3 ) flexible carrier; ( 24 ) photosensitive layer of the PIN diode; ( 25 ) NaCl gel pad, soaked with detergents to degrease the skin etc .; ( 26 ) Silver chloride; ( 27 ) metallic silver as an element of the Peltier cascade; ( 28 ) Titanium compound as an electrical conductor but poor heat conductor, ( 29 ) metallic silver; ( 30 ) n-doped bismuth telluride; ( 31 ) p-doped bismuth telluride; ( 32 ) Cavity (vacuum); ( 33 ) Transistor base of the impedance input amplifier; ( 34 ) capacitive coupling; ( 35 ) Peltier circuit

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - JP 62251662A [0100]

Cited non-patent literature

• - www.superbrightleds.com [0101]
• - Federal Standard 1037C [0104]
• - "American National Standard T1.523-2001, Telecom Glossary 2000" [0104]
• - DIN IEC 60751 [0105]
• - www.atmel.com/literature [0108]
• - www.anadigics.com [0110]
• - "Advance Article" on WEB on February 12, 2007 [0113]

Claims (14)

Method for the potential-free detection and evaluation of measured values for the determination and / or monitoring of vital functions in humans, characterized in that in a flexible carrier element electrodes, measuring elements or sensors, an electrical energy source and electronics for processing and transmitting the measured values are combined flexible support member placed and fixed on the body of the person to be examined for the duration of the measured value recording, z. B. is glued, and that the processed measurement signals are transmitted wirelessly from the carrier element to a signal evaluation device and / or to a display. Method according to claim 1, characterized in that that with the help of current electrodes an impressed current (continuous current) in the measuring range, d. H. in the area of the skin surface, on which the adhesive carrier element rests, caused and that with the help of further electrodes (internal electrodes) the Impedance of the body portion and / or impedance changes be determined. Method according to claim 1 or 2, characterized that the carrier element with measuring elements or sensors to detect all or some of the following body signals or vital information is equipped: acceleration signals for position and movement of the person, sound signals, light reflection signals and signal changes, temperature and Temperature changes, Frequency dependence of the impedance, and that this Measurement signals simultaneous and completely self-sufficient without a connection be derived to an external energy source. Apparatus for carrying out the method according to one or more of claims 1 to 3, characterized characterized in that it consists essentially of a flexible, on the body of the person to be examined for the Duration of the investigation to be attached, z. B. adhesive carrier element consists of current electrodes and measuring electrodes, with measuring elements and / or measuring sensors, with an electrical energy source or an energy storage, with electronic circuits for processing and / or conversion of the measurement signals and equipped with a signal transmission device is the measurement data and / or signals derived from the measurement data and information wirelessly to a signal evaluation device and / or to an ad. Device according to claim 4, characterized in that that the flexible support element made of a skin-friendly Carrier material exists and dimensions of the following order of magnitude identifies: Length 10 to 50 cm; Width 1 to 10 cm; Thickness 0.5 to 2 cm Apparatus according to claim 4 or 5, characterized in that in the carrier element as signal transmission device a transmitter module is integrated, which can send up to 48 hours. Device according to one or more of the claims 4 to 6, characterized in that in the evaluation of the measurement signals by bundling measurement signals from different sources redundant information is obtained and that these are redundant Information on plausibility checks be used. Device according to one or more of the claims 4 to 7, characterized in that these two or more consists of the elastic support elements, which by push buttons, Velcro or the like with each other electrically and over the signal evaluation device are coupled by data technology. Device according to one or more of the claims 4 to 8, characterized in that some of the electrodes, the Measuring elements or sensors and / or the components of the electronic Circuits for processing and / or conversion of the measurement signals, in particular the amplifier stages, with cooling devices, eg. B. based on the Peltier effect, are provided. Device according to one or more of the claims 4 to 8, characterized in that all possible permutations between the five independent signal sources body voltage, Acceleration (including sound), light absorption, temperature and electrical impedance freely selected for evaluation and evaluated can be. Device according to one or more of the claims 4 to 8, characterized in that by coupling several BIOSENSORen additional terms for the determination of Blood pressure change in the corresponding body regions can be obtained. Device according to one or more of the claims 4 to 8, characterized in that by coupling several BIOSENSORen regional liquid contents can be determined. Device according to one or more of the claims 4 to 8, characterized in that by coupling several BIOSENSORen regional flow conditions are determined can. Device according to one or more of the claims 4 to 8, characterized in that by placing more BIOSENSORS on the leg Activities of the voluntary musculature or the antigravity muscles can be determined.