WO1995012352A1 - Device and process for ulcer prophylaxis and early recognition of neuropathy in the foot of a diabetic - Google Patents

Device and process for ulcer prophylaxis and early recognition of neuropathy in the foot of a diabetic Download PDF

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Publication number
WO1995012352A1
WO1995012352A1 PCT/DE1994/001279 DE9401279W WO9512352A1 WO 1995012352 A1 WO1995012352 A1 WO 1995012352A1 DE 9401279 W DE9401279 W DE 9401279W WO 9512352 A1 WO9512352 A1 WO 9512352A1
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data
measuring
computer
ulcer prophylaxis
measuring points
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PCT/DE1994/001279
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German (de)
French (fr)
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Roland Leyerer
Peter Schaff
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Paromed Medizintechnik Gmbh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/1036Measuring load distribution, e.g. podologic studies

Definitions

  • the invention relates to a device and a method for ulcer prophylaxis and for the early detection of neuropathy in the diabetic foot.
  • the motor disorder occurs before the sensitive disorder, because the motor skills of the nerves in the muscular area are more likely to be damaged than in the sensitive area, it is possible to detect the onset of neuropathy in a standing test.
  • the object of the present invention is a
  • a device for ulcer prophylaxis and for early detection of neuropathy in the diabetic foot consisting of a measuring surface, such as a pair of soles or a platform with measuring points, the measuring points being pressure sensors, such as integrated pressure sensors from hydro cells with microsensors arranged underneath, and wherein the analog values detected by the pressure sensors are fed to a computer and evaluated there by a program, the measuring points are connected to the computer via preprocessing interface electronics with an analog-to-digital converter and the data are evaluated online by the program, the data being transferred by the interface electronics to the computer via cable or wireless.
  • At least 3, but preferably 16 measuring points are arranged at the anatomically important points on the measuring surface per foot.
  • an electronic visual medium for example a video device with a screen
  • the test subjects are distracted by a film to such an extent that they do not concentrate on standing.
  • requests to the Subjects are given, such as moving.
  • the measuring points are connected by cable to a measuring box to be carried by the test subject, which contains the analog-to-digital converter, filtering means such as depth pass or trigger and / or measured value correction means.
  • the data obtained is stored on a storage medium, e.g. a hard disk or a CD-ROM.
  • a storage medium e.g. a hard disk or a CD-ROM.
  • the pressure sensors can be piezoresitive, capacitive, inductive or resistive sensors.
  • the method according to the invention for ulcer prophylaxis and for the early detection of neuropathy in the diabetic foot contains the steps:
  • Fig. 3 shows a printout of a measurement result
  • Fig. 4 shows a printout of a measurement result
  • the subject 1 stands on two measuring soles 2, each with 16 measuring points.
  • the measurement results are delivered online via cable 3 and a preprocessing interface electronics 4 to the computer 5, where they are evaluated by a suitable program.
  • the subject 1 looks at the screen of a video terminal 6.
  • the computer 5 is connected to the video terminal 6.
  • the hardware structure can look as shown in FIG. 2.
  • the left sole 7 and the right sole 8 are connected by cable to a measuring box 9, which the
  • Converter card passes from where it is in an interrupt routine 12 in the computer 5 with timer 13 and Main memory 14, read in and evaluated there by the main program 15 and finally written to a hard disk 16.
  • the processing in the measuring box 9 can be influenced via a control line.
  • Fig. 3 and Fig. 4 show the different results in subjects without and with clearly diagnosed neuropathy. These are printouts of raw data.
  • the upper curve 18, 18 ' represents the load values of the right foot and the lower curve 17, 17' represents the load values of the left foot.
  • the larger the spaces 19, 19 'between these curves the more frequent and larger the load change between the two Feet. It is easy to see how much these values differ between the two subjects. While the subject shifted their weight continuously during standing in the 15 minutes of measurement without a clearly diagnosed neuropathy, the pressure values in the subject with clearly diagnosed neuropathy are almost the same for both feet over the entire period.

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Abstract

A device for ulcer prophylaxis and early recognition of neuropathy in the foot of a diabetic consists of a measuring surface, such as a pair of soles or a platform with measuring points, where the measuring points are integrated pressure sensors in the form of hydrocells with microsensors underneath them, where the analog values detected by the pressure sensors are fed to a computer and there evaluated by a program, and where the measuring points are linked to the computer through a preprocessing electronic interface with an A-D converter and the data are evaluated by the program on-line, the data being transmitted from the electronic interface to the computer by cable or in an uncable mode.

Description

Vorrichtung und Verfahren zur Ulcusprophylaxe und zur Früherkennung der Neuropathie beim diabetischen FußDevice and method for ulcer prophylaxis and early detection of neuropathy in the diabetic foot
Beschreibungdescription
Die Erfindung betrifft eine Vorrichtung und ein Verfahren zur Ulcusprophylaxe und zur Früherkennung der Neuropathie beim diabetischen Fuß.The invention relates to a device and a method for ulcer prophylaxis and for the early detection of neuropathy in the diabetic foot.
Es hat sich herausgestellt, daß sich die Druckverteilung während des Stehens eines Diabetikers mit peripherer Neuropathie sich von der einer Normalperson unterscheidet. Die Belastungsverlagerung findet seltener statt.It has been found that the pressure distribution during the standing of a diabetic with peripheral neuropathy differs from that of a normal person. The shift in stress takes place less frequently.
Aus der DE-U-92 03 788 ist eine Schuheinlage zur Ulcusprophylaxe am diabetischen Fuß bekannt, bei der über Drucksensoren bestimmte Belastungswerte erfaßt werden und der Patient über ein Signal aufgefordert wird, die Belastung eines Fußes, d.h. die Stehhaltung zu ändern.From DE-U-92 03 788 a shoe insert for ulcer prophylaxis on the diabetic foot is known, in which certain load values are recorded via pressure sensors and the patient is asked via a signal to indicate the load on a foot, i.e. to change the standing posture.
Da die motorische Störung vor der sensiblen Störung auftritt, weil die Motorik der Nerven im muskulären Bereich eher geschädigt wird, als im sensitiven Bereich, ist es möglich, eine beginnende Neuropathie bereits bei einem Stehtest zu erfassen.Since the motor disorder occurs before the sensitive disorder, because the motor skills of the nerves in the muscular area are more likely to be damaged than in the sensitive area, it is possible to detect the onset of neuropathy in a standing test.
Aufgabe der vorliegenden Erfindung ist es, eineThe object of the present invention is a
Vorrichtung und ein Verfahren zur Ulcusprophylaxe und zur Früherkennung der Neuropathie am diabetischen Fuß zu schaffen. Diese Aufgabe wird mit den im kennzeichnenden Teil des Anspruchs 1, bzw. im Anspruch 7 genannten Merkmalen gelöst. Fortbildungen und vorteilhafte Ausführungen der Erfindung sind in den weiteren Ansprüchen umfaßt.To provide a device and a method for ulcer prophylaxis and for the early detection of neuropathy on the diabetic foot. This object is achieved with the features mentioned in the characterizing part of claim 1 and in claim 7. Developments and advantageous embodiments of the invention are included in the further claims.
Erfindungsgemäß sind bei einer Vorrichtung zur Ulcusprophylaxe und zur Früherkennung der Neuropathie beim diabetischen Fuß, bestehend aus einer Meßfläche, wie einem Sohlenpaar oder einer Plattform mit Meßpunkten, wobei die Meßpunkte Drucksensoren, wie zum Beispiel integrierte Drucksensoren aus Hydrozellen mit darunterliegend angeordneten Microsensoren sind, und wobei die von den Drucksensoren erfaßten analogen Werte einem Rechner zugeleitet und dort von einem Programm ausgewertet werden, die die Meßpunkte über eine vorverarbeitende Interfaceelektronik mit einem Analog- Digital-Wandler an den Rechner angeschlossen und die Daten werden online von dem Programm ausgewertet, wobei die Datenübertragung von der Interfaceelektronik zu dem Rechner über Kabel oder kabellos erfolgt. Je Fuß sind mindestens 3, vorzugsweise aber 16 Meßpunkte an den anatomisch wichtigen Stellen auf der Meßfläche angeordnet.According to the invention are in a device for ulcer prophylaxis and for early detection of neuropathy in the diabetic foot, consisting of a measuring surface, such as a pair of soles or a platform with measuring points, the measuring points being pressure sensors, such as integrated pressure sensors from hydro cells with microsensors arranged underneath, and wherein the analog values detected by the pressure sensors are fed to a computer and evaluated there by a program, the measuring points are connected to the computer via preprocessing interface electronics with an analog-to-digital converter and the data are evaluated online by the program, the data being transferred by the interface electronics to the computer via cable or wireless. At least 3, but preferably 16 measuring points are arranged at the anatomically important points on the measuring surface per foot.
Um zu gesicherten Meßwerten zu kommen, hat es sich als vorteilhaft erwiesen, im Sichtbereich eines auf der Meßfläche stehenden Probanden ein elektronisches visuelles Medium, z.B. ein Videogerät mit Bildschirm, anzuordnen, welches mit dem Rechner verbunden ist, der in Abhängigkeit der ausgewerteten Daten Informationen durch das Medium abgibt. So werden die Probanden beispielsweise durch einen Film soweit abgelenkt, daß sie sich nicht auf das Stehen konzentrieren. Bei bestimmten Meßwerten können Aufforderungen an die Probanden abgegeben werden, wie zum Beispiel sich zu bewegen.In order to obtain reliable measured values, it has proven to be advantageous to arrange an electronic visual medium, for example a video device with a screen, in the field of view of a subject standing on the measuring surface, which is connected to the computer, which provides information depending on the evaluated data releases the medium. For example, the test subjects are distracted by a film to such an extent that they do not concentrate on standing. For certain measured values, requests to the Subjects are given, such as moving.
Nach einer vorteilhaften Ausführung der Erfindung sind die Meßpunkte über Kabel mit einer vom Probanden zu tragenden Meßbox verbunden, die den Analog-Digital- Wandler, Filtermittel, wie Tiefenpaß oder Trigger und/oder Meßwertkorrekturmittel enthält.According to an advantageous embodiment of the invention, the measuring points are connected by cable to a measuring box to be carried by the test subject, which contains the analog-to-digital converter, filtering means such as depth pass or trigger and / or measured value correction means.
Die gewonnenen Daten werden auf ein Speichermedium, z.B. eine Festplatte oder ein CD-ROM, gespeichert.The data obtained is stored on a storage medium, e.g. a hard disk or a CD-ROM.
Die Drucksensoren können piezoresitive, kapazitive, induktive oder resistive Sensoren sein.The pressure sensors can be piezoresitive, capacitive, inductive or resistive sensors.
Das erfindungsgemäße Verfahren zur Ulcusprophylaxe und zur Früherkennung der Neuropathie beim diabetischen Fuß, enthält die Schritte:The method according to the invention for ulcer prophylaxis and for the early detection of neuropathy in the diabetic foot contains the steps:
- Eingabe von Daten in einen mit einem Programm zur Erfassung und Auswertung versehenen Rechner zur- Input of data in a computer provided with a program for recording and evaluation
Aktivierung eines Treibers;Activation of a driver;
- Stellen eines Probanden mit beiden Füßen auf eine Meßfläche, die mit Meßpunkten aus integrierten Drucksensoren aus Hydrozellen mit darunterliegenden Microsensoren versehen ist;- Place a subject with both feet on a measuring surface, which is provided with measuring points from integrated pressure sensors made of hydro cells with microsensors underneath;
- Weitergabe der gewonnenen Druckdaten an eine vom Probanden zu tragende Meßbox;- Forwarding of the obtained print data to a measuring box to be carried by the test person;
- Weitergabe der Daten innerhalb der Meßbox oder von der Meßbox über ein Kabel oder kabellos an eine AD- Wandlerkarte;- Forwarding of the data within the measuring box or from the measuring box via a cable or wirelessly to an AD converter card;
- Übertragen der Daten über Kabel oder kabellos an einen Rechner;- Transfer the data via cable or wirelessly to a computer;
- Auswerten und Speichern der Daten und Ausgabe auf einen Bildschirm, wobei sowohl die von den beiden Füßen kommenden Daten, als auch die verschiedenen Daten jeweils eines Fußes miteinander verglichen werden;- Evaluate and save the data and output on a screen, using both of the two feet coming data, as well as the different data of each foot are compared;
- Online-Informationsausgabe an den Probanden über ein mit dem Rechner verbundenes elektronisches visuelles Medium;- Online information output to the test subjects via an electronic visual medium connected to the computer;
- Informationsausgabe des Mediums an den Probanden.- Information output of the medium to the test subjects.
Im folgenden wird die Erfindung anhand von Zeichnungen beispielhaft näher beschrieben. Dabei zeigen:The invention is described in more detail below by way of example with reference to drawings. Show:
Fig. 1 einen Meßaufbau;1 shows a measurement setup;
Fig. 2 einen beispielsweisen Hardware-Aufbau;2 shows an exemplary hardware structure;
Fig. 3 einen Ausdruck eines Meßergebnisses einesFig. 3 shows a printout of a measurement result
Probanden ohne eindeutig diagnostizierte Neuropathie;Subjects without clearly diagnosed neuropathy;
Fig. 4 einen Ausdruck eines Meßergebnisses einesFig. 4 shows a printout of a measurement result
Probanden mit eindeutig diagnostizierterSubjects with clearly diagnosed
Neuropathie.Neuropathy.
Bei der Meßanordnung gemäß Fig. 1 steht der Proband 1 auf zwei Meßsohlen 2 mit jeweils 16 Meßpunkten. Die Meßergebnisse werden über Kabel 3 und eine vorverarbeitende Interfaceelektronik 4 online an den Rechner 5 geliefert, wo sie von einem geeigneten Programm ausgewertet werden. Der Proband 1 blickt auf den Bildschirm eines Videoterminals 6. Der Rechner 5 ist mit dem Videoterminal 6 verbunden.In the measuring arrangement according to FIG. 1, the subject 1 stands on two measuring soles 2, each with 16 measuring points. The measurement results are delivered online via cable 3 and a preprocessing interface electronics 4 to the computer 5, where they are evaluated by a suitable program. The subject 1 looks at the screen of a video terminal 6. The computer 5 is connected to the video terminal 6.
Der Hardwareaufbau kann, wie in Fig. 2 gezeigt, aussehen. Die linke Sohle 7 und die rechte Sohle 8 sind über Kabel an eine Meßbox 9 angeschlossen, die dieThe hardware structure can look as shown in FIG. 2. The left sole 7 and the right sole 8 are connected by cable to a measuring box 9, which the
Daten bündelt und über Kabel an eineBundles data and via cable to one
Interfaceelektronik 11 mit einem Timer und einer AD-Interface electronics 11 with a timer and an AD
Wandlerkarte leitet, von wo sie in einer Interruptroutine 12 in den Rechner 5 mit Timer 13 und Hauptspeicher 14, eingelesen und dort vom Hauptprogramm 15 ausgewertet und schließlich auf eine Festplatte 16 geschrieben werden. Über eine Steuerleitung kann auf die Verarbeitung in der Meßbox 9 Einfluß genommen werden.Converter card passes from where it is in an interrupt routine 12 in the computer 5 with timer 13 and Main memory 14, read in and evaluated there by the main program 15 and finally written to a hard disk 16. The processing in the measuring box 9 can be influenced via a control line.
Fig. 3 und Fig. 4 zeigen die unterschiedlichen Ergebnisse bei Probanden ohne und mit eindeutig diagnostizierter Neuropathie. Es handelt sich hier um Ausdrucke von Rohdaten. Die obere Kurve 18, 18' stellt die Belastungswerte des rechten Fußes und die untere Kurve 17, 17' die Belastungswerte des linken Fußes dar. Je größer die Zwischenräume 19, 19' zwischen diesen Kurven sind, desto häufiger und größer ist der Belastungswechsel zwischen beiden Füßen. Es ist gut zu erkennen, wie sehr sich diese Werte bei den beiden Probanden unterscheiden. Während die Versuchsperson ohne eindeutig diagnostizierte Neuropathie in den 15 Meßminuten ständig beim Stehen das Gewicht verlagert, so sind die Druckwerte bei der Versuchsperson mit eindeutig diagnostizierter Neuropathie über die gesamte Zeit bei beiden Füßen fast gleich. Fig. 3 and Fig. 4 show the different results in subjects without and with clearly diagnosed neuropathy. These are printouts of raw data. The upper curve 18, 18 'represents the load values of the right foot and the lower curve 17, 17' represents the load values of the left foot. The larger the spaces 19, 19 'between these curves, the more frequent and larger the load change between the two Feet. It is easy to see how much these values differ between the two subjects. While the subject shifted their weight continuously during standing in the 15 minutes of measurement without a clearly diagnosed neuropathy, the pressure values in the subject with clearly diagnosed neuropathy are almost the same for both feet over the entire period.

Claims

Patentansprüche claims
1. Vorrichtung zur Ulcusprophylaxe und zur Früherkennung der Neuropathie beim diabetischen Fuß, bestehend aus einer Meßfläche, wie einem Sohlenpaar oder einer Plattform mit Meßpunkten, wobei die Meßpunkte Drucksensoren sind, und wobei die von den Drucksensoren erfaßten analogen Werte einem Rechner zugeleitet und dort von einem Programm ausgewertet werden, d a d u r c h g e k e n n z e i c h n e t, daß die Meßpunkte über eine vorverarbeitende Interfaceelektronik mit einem Analog-Digital-Wandler an den Rechner angeschlossen sind, und daß die Daten online von dem Programm ausgewertet werden, wobei die Datenübertragung von der Interfaceelektronik zu dem Rechner über Kabel oder kabellos erfolgt.1. Device for ulcer prophylaxis and for the early detection of neuropathy in the diabetic foot, consisting of a measuring surface, such as a pair of soles or a platform with measuring points, the measuring points being pressure sensors, and wherein the analog values detected by the pressure sensors are fed to a computer and there from one Program are evaluated, characterized in that the measuring points are connected to the computer via a preprocessing interface electronics with an analog-digital converter, and that the data are evaluated online by the program, the data transmission from the interface electronics to the computer via cable or wirelessly he follows.
2. Vorrichtung zur Ulcusprophylaxe nach Anspruch 1, d a d u r c h g e k e n n z e i c h n e t, daß im Sichtbereich eines auf der Meßfläche stehenden Probanden ein elektronisches visuelles Medium angeordnet ist, daß das Medium mit dem Rechner verbunden ist, und daß der Rechner in Abhängigkeit der ausgewerteten2. Device for ulcer prophylaxis according to claim 1, d a d u r c h g e k e n n z e i c h n e t that an electronic visual medium is arranged in the field of view of a subject standing on the measuring surface, that the medium is connected to the computer, and that the computer depending on the evaluated
Daten Informationen durch das Medium abgibt.Data provides information through the medium.
3. Vorrichtung zur Ulcusprophylaxe nach Anspruch 1 , d a d u r c h g e k e n n z e i c h n e t, daß je Fuß mindestens 3, vorzugsweise 16 Meßpunkte an den anatomisch wichtigen Stellen auf der Meßfläche angeordnet sind. 3. Device for ulcer prophylaxis according to claim 1, characterized in that at least 3, preferably 16 measuring points are arranged at the anatomically important points on the measuring surface per foot.
4. Vorrichtung zur Ulcusprophylaxe nach Anspruch 1, d a d u r c h g e k e n n z e i c h n e t, daß die Meßpunkte über Kabel mit einer vom Probanden zu tragenden Meßbox verbunden sind, und daß die Meßbox den Analog-Digital-Wandler,4. Apparatus for ulcer prophylaxis according to claim 1, d a d u r c h g e k e n n z e i c h n e t that the measuring points are connected by cable to a measuring box to be carried by the test subject, and that the measuring box the analog-digital converter,
Filtermittel, wie Tiefenpaß oder Trigger und/oderFilter means, such as depth pass or trigger and / or
Meßwertkorrekturmittel enthält.Measured value correction means contains.
5. Vorrichtung zur Ulcusprophylaxe nach Anspruch 1, d a d u r c h g e k e n n z e i c h n e t, daß die gewonnenen Daten auf ein Speichermedium gespeichert werden.5. Device for ulcer prophylaxis according to claim 1, d a d u r c h g e k e n n z e i c h n e t that the data obtained are stored on a storage medium.
6. Vorrichtung zur Ulcusprophylaxe nach Anspruch 1, d a d u r c h g e k e n n z e i c h n e t, daß die Drucksensoren piezoresistive, kapazitive, induktive oder resistive Sensoren sind.6. Device for ulcer prophylaxis according to claim 1, d a d u r c h g e k e n n z e i c h n e t that the pressure sensors are piezoresistive, capacitive, inductive or resistive sensors.
7. Verfahren zur Ulcusprophylaxe und zur Früherkennung der Neuropathie beim diabetischen Fuß, g e k e n n z e i c h n e t durch die Schritte:7.Procedures for ulcer prophylaxis and early detection of neuropathy in the diabetic foot, g e k e n n e e i c h n e t by the steps:
- Eingabe von Daten in einen mit einem Programm zur Erfassung und Auswertung versehenen Rechner zur Aktivierung eines Treibers;- Input of data in a computer provided with a program for recording and evaluation to activate a driver;
- Stellen eines Probanden mit beiden Füßen auf eine Meßfläche, die mit Meßpunkten aus integrierten Drucksensoren aus Hydrozellen mit darunterliegenden Microsensoren versehen ist; - Weitergabe der gewonnenen Druckdaten an eine vom Probanden zu tragende Meßbox;- Place a subject with both feet on a measuring surface, which is provided with measuring points from integrated pressure sensors made of hydro cells with microsensors underneath; - Forwarding of the obtained print data to a measuring box to be carried by the test person;
- Weitergabe der Daten innerhalb der Meßbox oder von der Meßbox über ein Kabel oder kabellos an eine AD- Wandlerkarte;- Forwarding of the data within the measuring box or from the measuring box via a cable or wirelessly to an AD converter card;
- Übertragen der Daten über Kabel oder kabellos an einen Rechner;- Transfer the data via cable or wirelessly to a computer;
- Auswerten und Speichern der Daten und Ausgabe auf einen Bildschirm, wobei sowohl die von den beiden Füßen kommenden Daten, als auch die verschiedenen Daten jeweils eines Fußes miteinander verglichen werden;- Evaluation and storage of the data and output on a screen, both the data coming from the two feet and the different data of each foot being compared;
- Online-Informationsausgabe an den Probanden über ein mit dem Rechner verbundenes elektronisches visuelles Medium; - Informationsausgabe des Mediums an den Probanden. - Online information output to the test subjects via an electronic visual medium connected to the computer; - Information output of the medium to the test subjects.
PCT/DE1994/001279 1993-11-04 1994-11-02 Device and process for ulcer prophylaxis and early recognition of neuropathy in the foot of a diabetic WO1995012352A1 (en)

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ES2131002A1 (en) * 1997-06-23 1999-07-01 Meditel Ingenieria Medica S L Portable system for the static and dynamic analysis of the pressure (support) of the foot
WO2009132521A1 (en) * 2008-04-29 2009-11-05 香港理工大学 Foot sole soft tissue measurement system
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DE102014104698B4 (en) * 2014-04-02 2015-12-10 Ryszard Bukszynski Device for measuring the impact force of a foot while walking
CN117338301A (en) * 2023-10-17 2024-01-05 首都医科大学宣武医院 Diabetes foot risk level evaluation system based on electromyographic signals
CN117338301B (en) * 2023-10-17 2024-03-29 首都医科大学宣武医院 Diabetes foot risk level evaluation system based on electromyographic signals
CN117994251A (en) * 2024-04-03 2024-05-07 华中科技大学同济医学院附属同济医院 Method and system for evaluating severity of diabetic foot ulcer based on artificial intelligence

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