SIGNALING DEVICE FOR CATHETERING REQUIREMENT

Abstract

A signaling device including a data processing device; sensors for heart rate, breathing activity, galvanic skin response, skin blood flow, and movement of a person which respectively include radio communication devices for a wireless connection to the data processing device, wherein the data processing device is configured to wirelessly receive data captured by the sensors regarding a physiological condition of the person and to generate an acoustic, visual or tactile signal as a function of a change of the physiological condition, wherein the data processing device is configured to store the captured data in measurement series, to analyze the measurement series and to detect an increasing or excursive change of the condition in the measurement series, wherein the signal indicates a catheterization requirement of the person.

Claims

1. A signaling device comprising: a data processing device; and sensors that detect one or more of heart rate, breathing activity, galvanic skin response, skin blood flow, and movement of a person which respectively include radio communication devices for a wireless connection to the data processing device, wherein the data processing device is configured to wirelessly receive data captured by the sensors regarding a physiological condition of the person and to generate an acoustic, visual or tactile signal as a function of a change of the physiological condition, wherein the data processing device is configured to store the data in measurement series, to analyze the measurement series and to detect an increasing or excursive change of the physiological condition in the measurement series, and wherein the signal indicates a catheterization requirement of the person.

2. The signaling device according to claim 1, further comprising: adjustment devices for manually adjusting a sensitivity of the sensors.

3. The signaling device according to claim 1, further comprising: a control device for manually validating the signal.

4. The signaling device according to claim 3, further comprising: an expert system configured to automatically calibrate a threshold value for the increasing or excursive change based on a manual validation of the signal by the control device.

5. The signaling device according to claim 1, further comprising: additional sensors that detect skin blood circulation, skin humidity, movements and for heart rate of a person.

6. The signaling device according to claim 1, further comprising: a real time clock.

7. The signaling device according to claim 1, further comprising: a signaling element that is wirelessly connected to the data processing device and configured to generate the signal.

8. The signaling device according to claim 1, further comprising: a control element that is connected to the data processing device.

9. The signaling device according to claim 1, wherein the control element is implemented in a smartphone.

10. The signaling device according to claim 1, wherein the sensors detect the heart rate, the breathing activity, the galvanic skin response, the skin blood flow, and the movement of a person.

11. A method for detecting a catheterization requirement comprising: providing a data processing device; and providing sensors that detect two or more of heart rate, breathing activity, galvanic skin response, skin blood flow, and movement of a person which respectively include radio communication devices for a wireless connection to the data processing device, wherein the data processing device is configured to wirelessly receive data captured by the sensors regarding a physiological condition of the person and to generate an acoustic, visual or tactile signal as a function of a change of the physiological condition, wherein the data processing device is configured to store the data in measurement series, to analyze the measurement series and to detect an increasing or excursive change of the physiological condition in the measurement series, and wherein the signal indicates a catheterization requirement of the person.

12. The method of claim 11, further comprising: limiting the sensors to a subset of sensors able to detect the increasing or excursive change of the physiological condition when at least one of the sensors is unable to detect the increasing or excursive change of the physiological condition.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0027] The invention will be described in detail with reference to the following drawings in which like reference numerals refer to like elements wherein:

[0028] FIG. 1 illustrates an exemplary embodiment of the signaling device of the invention;

[0029] FIG. 2 is a graph of breathing associated chest wall movements with a steady state;

[0030] FIG. 3 is a graph of breathing associated chest wall movements with leaping changes;

[0031] FIG. 4 is a graph of ECG derived heart rate variability;

[0032] FIG. 5 is a graph of ECG derived time series of a heart rate in a resting state;

[0033] FIG. 6 is a graph of breathing associated chest wall movements in a healthy volunteer in steady state;

[0034] FIG. 7 is a graph of ECG derived heart rate variability with leaping changes;

[0035] FIG. 8 is a graph of ECG derived time series of heart rate in a healthy volunteer with an application of a pain stress showing an increasing change; and

[0036] FIG. 9 is a graph of ECG derived time series of heart rate in a healthy volunteer with an application of a pain stress showing an excursive change.

DETAILED DESCRIPTION OF THE INVENTION

[0037] The signaling device 1 illustrated in FIG. 1 includes a data processing device 2, plural (e.g., three or four or more) sensors 3, and a user application that is installed on a smartphone 4 but not illustrated in more detail.

[0038] The sensors 3 are configured as a sensor mat for measuring electrical heart activity (ECG, e.g. ADS1292R, Texas Instruments) and breathing of a person that is not illustrated, a photo plethysmography sensor for measuring skin blood circulation combined with a GSR sensor for measuring skin humidity (e. g. Osram SFH7060), and a motion sensor for measuring voluntary and involuntary movements (e. g. ADXL354C, Analog Devices). The sensors 3 respectively include a Bluetooth radio module. The sensor mat is positioned on the upper back area or the chest region. The reflection photo pletysmography sensor is positioned at the ear lobe or incorporated in the sensor mat used to measure electrical heart activity and/or breathing motions. The motion sensor is positioned individually different on predilection locations on the limbs (e.g., a paraplegic patient with involuntary rocking of right big toe indicating catheterization requirement) known to exhibit motion changes due to pain-stress reactions. The GSR sensor is positioned on predilection locations (e.g., sweating inside of the elbow indicating catheterization requirement) known to respond with skin humidity changes to pain-stress reactions.

[0039] The reason for such rather unpredictable physical signs indicating catheterization requirement is nerves conduct impulses in the body even when paralyzed. Although the physical signs resulting from the conducted impulses are unpredictable from person to person, the physical signs will be consistent for a given person. Determining such a physical sign and/or predilection location may be achieved by attaching sensors 3 and analyzing the resultant data. There will be one or more differences between the data of a person when a catheterization requirement is indicated (pain-stress reaction) and when a catheterization is not indicated (resting state). The one or more differences will be an increasing (progressive) and/or leaping and/or excursive condition change associated with unconscious autonomic and somato-motoric pain-stress reactions resulting from high bladder pressure.

[0040] Initially, a full range of sensors are used but once it is determined which of the sensors are able to detect the increasing or excursive change of the physiological condition, the other sensors may be omitted. Of course, in some instances, there may be other reasons to keep some of the sensors.

[0041] The data processing device 2 is a commercially available microcomputer including a processing, an operating memory, a real time clock and a Bluetooth radio module which is configured with a software to wirelessly receive data regarding a condition of a person that is captured by the sensors 3 and to generate a signal for an increasing (progressive) and/or leaping condition change associated with unconscious autonomic and somato-motoric pain-stress reactions associated with high bladder pressure.

[0042] In order to use the signaling device 1 the sensors 3 are initially applied to locations at a body of the person which do not further impede the mobility of the typically physically handicapped person. Since unconscious autonomic and somato-motoric pain-stress reactions associated with high bladder pressure may not affect neurologically healthy sections of a neurologically impaired person, save for ECG sensors all other sensors 3 are applied at predilection locations that will supply signals useful for detection of such unconscious autonomic and somato-motoric pain-stress reactions associated with high bladder pressure. Then the data processing device 2 is connected to the smartphone 4 through Bluetooth and configured by the user application.

[0043] The data processing device 2 detects the sensors 3 arranged in the proximity, establishes a data connection with the sensors via Bluetooth and performs a start configuration of the measurement, namely recording baseline activity at rest. The data processing device 2 thus defines a resting state parameter configuration, divides the distance between two measurements into four time windows and assigns one of the time windows to each of the sensors 3. From this point in time forward, the sensors 3 transmit their respective measuring value regarding the condition of the person in the assigned time window to the data processing device 2 in the measuring rhythm. A typical graphical representation of the values measured is shown in FIGS. 2-9.

[0044] The data processing device 2 automatically analyzes the time series of the measurements and detects increasing (progressive) and/or leaping changes associated with unconscious autonomic and somato-motoric pain-stress reactions associated with high bladder pressure indicating alterations of the condition of the person with a sensibility that is initially very high. As soon as the data processing device 2 detects increasing (progressive) and/or leaping changes associated with unconscious autonomic and somato-motoric pain-stress reactions associated with high bladder pressure, the user application generates a tactile, acoustic and visual signal by vibration, a signal tone and an illumination of an LED which may be indicative of a catheterization requirement. Thereupon the user is encouraged to validate the catheterization requirement by actuating a key that is represented on the screen, thus confirming or rejecting the potential catheterization requirement.

[0045] With each validated signal an expert system that is implemented in the data processing device 2 learns differentiate which of the increasing (progressive) and/or leaping changes measured indicates an actual catheterization requirement thereby enhancing the discriminatory power of the expert system. A number of erroneous signals decreases approximately exponentially with the number of the signals. Analyzing the measurement series the data processing device 2 also determines the actually required measuring sensitivity of the measuring sensors 3 and the actually required measuring cycle and responds to these analyses with automated adaptation.

[0046] Through the user application the user can increase or decrease the measuring sensitivity of the signaling device 1 overall and for each individual sensor any time through virtual slider elements and can lengthen or shorten the measuring cycles.

[0047] The user application connects through the internet 5 with a server 6 of the manufacturer in regular intervals when the smartphone 4 provides a data connection and transmits anonymized operating data of the signaling device 1 to the server 6. Based on this data the user application as well as the software of the data processing device 2 is improved continuously.

[0048] FIG. 2 is a graph of breathing associated chest wall movements with a steady state.

[0049] FIG. 3 is a graph of breathing associated chest wall movements with leaping changes.

[0050] FIG. 4 is a graph of ECG derived heart rate variability.

[0051] FIG. 5 is a graph of ECG derived time series of a heart rate in a resting state. In FIG. 5, the X-axis is recording time in seconds and the Y-axis is the time between consecutive heart depolarizations converted to beats per minute.

[0052] FIG. 6 is a graph of breathing associated chest wall movements in a healthy volunteer in steady state. In FIG. 6, the X-axis is recording time in seconds and the Y-axis is the time between breathing associated thoracic movements in seconds.

[0053] FIG. 7 is a graph of ECG derived heart rate variability with leaping changes.

[0054] FIG. 8 is a graph of ECG derived time series of heart rate in a healthy volunteer with an application of a pain stress showing an increasing change. The application of pain-stress (cold pressure) occurs at a particular time 80 with a resulting increasing change (negative gain) due to the pain-stress (cold pressure test). The X-axis is recording time in seconds and the Y-axis is the time between consecutive heart depolarizations in seconds.

[0055] FIG. 9 is a graph of ECG derived time series of heart rate in a healthy volunteer with an application of a pain stress showing an excursive change. The application of pain-stress (cold pressure) occurs at a particular time 90 with a resulting excursive (saltatory) change (positive gain) due to pain-stress (cold pressure test). The X-axis is recording time in seconds and the Y-axis is the time between consecutive heart depolarizations converted to beats per minute.

[0056] “Heart rate” (HR) means time intervals between two consecutive depolarizations of the heart muscle per minute measured as electrical activity with unipolar or bipolar ECG. A typical graphical representation of computed HR values is illustrated in FIG. 5.

[0057] “Breathing” means chest or abdominal respiration related movements. A typical graphical representation of the values measured is shown in FIG. 2.

[0058] “Movement” of a person means changing of posture by positioning limbs or trunk of body or head or all of these or parts thereof. Movement is measured using an accelerometer able to detect changes in at least 3 axes of space.

[0059] “Increasing (progressive) change” means continuous positive or negative gain. A typical graphical representation of computed values during experimental pain using cold pressure test (immersing the non-dominant hand in ice cooled water) in a healthy volunteer is illustrated in FIG. 8.

[0060] In contrast, an “excursive or leaping change” of the condition means abrupt saltatory change of parameters. A typical graphical representation of an excursive change is illustrated in FIG. 9.

BRIEF DESCRIPTION OF THE DRAWINGS

[0061] 1 Signaling device [0062] 2 Data processing device [0063] 3 Sensor [0064] 4 Smartphone [0065] 5 Internet [0066] 6 Server [0067] 80 Particular time [0068] 90 Particular time