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EP4076170A1 - Appareil de surveillance de la thérapie par compression fournie par un moyen de compression - Google Patents

Appareil de surveillance de la thérapie par compression fournie par un moyen de compression

Info

Publication number
EP4076170A1
EP4076170A1 EP20808056.4A EP20808056A EP4076170A1 EP 4076170 A1 EP4076170 A1 EP 4076170A1 EP 20808056 A EP20808056 A EP 20808056A EP 4076170 A1 EP4076170 A1 EP 4076170A1
Authority
EP
European Patent Office
Prior art keywords
electrodes
compression
pair
measuring device
wearer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20808056.4A
Other languages
German (de)
English (en)
Inventor
Ferdinand TAMOUÉ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KOB GmbH
Original Assignee
KOB GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by KOB GmbH filed Critical KOB GmbH
Publication of EP4076170A1 publication Critical patent/EP4076170A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A61B5/6807—Footwear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/06—Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
    • A61F13/08—Elastic stockings; for contracting aneurisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053

Definitions

  • the invention relates to a device for monitoring the compression therapy of a compression means comprising a measuring device made of a textile material for application to a carrier with two end sections which enclose a central section between them.
  • compression bandages are applied to limbs for the treatment of edema and, for example, chronic venous insufficiency. Both compression bandages and, for example, compression bandages or compression stockings are known. Compression bandages have the advantage over compression bandages that the therapeutic dose of pressure can be corrected during application and the bandage can be continuously adapted to the affected part of the body when the swelling is reduced.
  • Compression therapy is made possible, and not by measuring the pressure, as was known in the past, but rather by monitoring the decrease in fluid in tissues treated by the compression, as this is the therapeutically desired measure.
  • WO 2019/008376 discloses a method in which a first conductive path is provided in a napkin and a sensor that measures the impedance of the napkin.
  • two electrodes are arranged in each end section, one electrode in each case forming an electrode pair with an electrode of the other end section, an electrical current flow being applied via one electrode pair and an electrical voltage between the electrodes of one electrode via the other electrode pair Pair is determined, wherein the electrodes are designed so that the electrical current is applied to a carrier
  • Measuring device between the electrodes of a pair flows through the body of the wearer beneath the skin or not through the skin.
  • the (bio) impedance can be used, which can be determined via the phase shift between the sinusoidal curve of the voltage and the sinusoidal curve of the current, which correlates with the fluid content in the monitored part of the body.
  • the electrodes should be designed in such a way that the current flows through the wearer's body beneath the skin and not just in the area of the skin. The current flow should take place in the intra- and extracellular tissue.
  • the impedance is the value by means of which a capillary pressure can be determined, which in phlebology and lymphology is regarded as an important parameter for biofiltration and drainage.
  • the capillary pressure describes the interface pressure between the static fluids of the vascular system and the vascular wall. An increase in pressure on the wall from the outside would induce a fluid displacement from one compartment to the next, and this fluid displacement can be represented via the electrical impedance.
  • a human body or limb can hypothetically be viewed as a capacitive resistance.
  • the body fluids electrolytes
  • P in mmHg a part of the body which is connected to an electrical circuit, whereby if the part of the body loses fluid through compression (P in mmHg), this can be determined by a variation in the electrical impedance (z), since the current flow (I) in this circle is mathematically proportional to the voltage (V).
  • a direct current source such as a battery or the like, for example, can serve as the power source, since this does not restrict the movement of a wearer too much and the space requirement and mobility the usability is increased.
  • An oscillator is arranged between the direct current source and the pair of electrodes in order to keep the amplitude of the current and the voltage stable and to enable an impedance measurement.
  • An evaluation device is preferably provided which determines the impedance of the body of a wearer via the phase shift, the change in the liquid content in the body area being considered causing the phase shift.
  • the textile material of the measuring device is a woven material and the electrodes are, in particular, woven electrodes. It can preferably be textile polymer electrodes. In this case, a coating can be applied in the electrode area which improves the conductivity, for example made of electrically conductive silicone or a graphite-based paste.
  • woven electrodes as they should preferably be used, the contact area with the skin of the wearer is important in order to avoid so-called "skin"
  • Equation 1 nVKe / t is the number of weft threads S is the electrical surface contact of the electrode
  • the technical variation Tv is linked to the parameters reed width and crimp percentage (crimp factor) in such a way that the lowest possible skin effects are created.
  • the Weber sheet (Reed) can be described in an indirect way by the mathematical equation of the width of the Weber sheet, since it allows the technical parameter to be varied.
  • the reed width is described by the following equation:
  • Rw is the reed width.
  • the Weber sheet, called reed, is described in terms of its width according to equation 2 by Fwidth.
  • Fwidth is the width of the woven fabric. Since the electrode is part of the fabric, the width of the fabric influences the technical variation of the electrode, namely the electrical surface contact. In order to provide their function for the impedance measurement, the electrodes are woven in in the weft direction (i.e. the width) of the fabric. There is thus a relationship between the width of the sheet-like structure and the desired size of the electrode. In addition to the width of the fabric, the way in which the threads are incorporated in the width (crimp) also has an influence. When producing the fabric, the warp threads cause a weft thread frizz, depending on their tension and the chosen weave. The weft frill is described by the wide crimp factor. Far Crimp Factor is the factor relating to the change in length of the weft in the sheet.
  • the surface contact correlates in a strongly negative way with the warp crimp factor ⁇ Warp Cf)
  • the warp crimp factor describes the warp thread frizz.
  • Equation 4 Surface contact
  • the device is a bandage, in particular a compression bandage.
  • the device can also be used as
  • compression stocking or as a cuff with or without a compression effect. If the device itself is able to apply the compression, a further additional compression device in the form of a bandage, for example, can be saved.
  • the electrodes of an end section are preferably arranged one above the other in the weft direction and have a preferred distance d h 5 cm.
  • the distance to the edge of the end section is in particular> 1 cm.
  • the weft direction corresponds to the transverse direction and the warp direction to the longitudinal direction.
  • the electrodes can be contacted via electrically conductive threads, which are in particular guided in the textile material and are connected via this in particular to the power source and / or the evaluation device. In this way, the contact is made without having to provide more cables than necessary for the contact.
  • one or both end sections can preferably be inelastic and the middle section can be elastic be designed in order to be able to better design the electrodes in the end sections and to determine the contact area with the carrier in a defined manner.
  • the elasticity of the middle section can be used to improve the fit and compression.
  • the stretchability and elasticity can be adjusted in a conventional manner and can be designed as a long-stretch or short-stretch bandage. In the case of the design as a cuff or stocking, the above applies analogously, so that here the areas of the electrodes are inelastic and the part arranged between them in the longitudinal direction of the limb is elastically stretchable.
  • the extensibility is preferably in the range from 40% to 100% of the unstretched length.
  • the extensibility is determined according to the following procedure based on DIN 61632:
  • a tensile tester can be used to determine the elongation.
  • a test piece of the flat structure (clamping length 200 mm) is loaded by a pulling speed of 200 mm / min up to a maximum force of 3N / cm width.
  • the test specimen is laid out without tension on a smooth, level surface (e.g. a table) for at least 15 minutes, after which it is clamped in the tensile tester and stretched.
  • the tensile tester determines the elongation and uses the unstretched length (L0) and the (LI). Lo is the initial length of the test item at start and LI is the length of the maximum force.
  • the electrically conductive threads must be introduced in such a way that they do not hinder the extensibility.
  • an electrically conductive coating can be applied in the area of the electrodes. This consists e.g. of an electrically conductive silicone or a graphite paste. This also makes it possible to compensate for the irregularities in the surface which result from the up and down movement of the thread in the case of woven electrodes and which has an influence on the contact surface.
  • the design of the electrodes e.g. with regard to the density of the weaving, can vary depending on whether a coating is provided.
  • the invention also relates to a method for determining the compression of a compression means by means of a measuring device made of a textile material, the measuring device being applied to a body, in particular a limb of a wearer, so that two end sections of the measuring device take up an area of a body to be measured between them , each end section having two electrodes, each of which interacts in pairs with the electrodes of the other end section and wherein an electrical current flow via the one pair of electrodes and an electrical voltage between the electrodes via the other pair of electrodes Pair is determined, the electric current flowing between the electrodes of a pair through the body of the wearer beneath the skin when the measuring device is placed on a wearer.
  • the bioimpedance of the body is preferably determined via the phase shift.
  • the measuring device is wrapped around the body as a bandage and also preferably serves as a compression means. Determining the qualitative change in the
  • Fluid content of a body both with regard to the intra- and extracellular fluid was carried out on a trial basis to demonstrate the function of the stated correlation between the effect of compression and thus the (removal) transport of fluid from the
  • a device in the form of a bandage was wrapped around the leg of a wearer serving as a test person, with two layers of bandage overlapping each other.
  • the stretching of the bandage was approx. 110% of the original length. Measurements were made in the lying, sitting and standing positions.
  • the test subjects were healthy.
  • the electrodes were not part of the device but were applied as adhesive electrodes to the skin of the test subjects. Before the experiment, the test subjects rested in a lying position for about 3 minutes. After each body movement, the body was given one minute of relaxation before the measurement.
  • the impedance was measured before compression. Impedance and pressure were bandaged in the three
  • test person then wore the bandage for several hours during their usual activities during this time, e.g. professional activities.
  • FIG. 6 shows that the impedance is initially low without compression and then increases with the compression and then decreases again when the compression decreases. This correlates with the liquid transport that is stimulated by the compression. If the compression ceases, the fluid transport in the cells and the extracellular transport also cease.
  • FIG. 1 a so-called body hydration model
  • FIG. 2 a mathematical model
  • FIG. 3 shows a device according to the invention in the form of a compression bandage
  • FIG. 4 shows a further illustration of the invention
  • FIG. 5 shows a bandage according to the invention
  • FIG. 6 shows the test result.
  • FIG. 1 shows a body hydration model which shows how the fluid is distributed in the body, namely both in the intracellular space and in the extracellular space, that is to say between the individual cells.
  • the intracellular fluid can pass through the pores in the cell membrane enter the extracellular space and be transported from there.
  • FIG. 2 shows the relationship between the bio-impedance and the interface pressure and thus the compression, as explained above.
  • a patient with edema therefore has a lower impedance value Z before therapy than during compression therapy. If, for example, venous insufficiency is treated in the usual way with a compression pressure of approx. 50 mmHg, it is to be expected that the patient will have a decreasing impedance value when the compression pressure increases to 80 mmHg, for example.
  • Monitoring the bio-impedance thus provides information about the evacuation of liquids in the intra- and extracellular space.
  • Figure 3 shows a first embodiment of the device 10 comprising a measuring device for a compression means, which is designed here as a bandage and at the same time forms the compression means.
  • two electrodes are provided here, the current being provided as direct current via a battery 30 in order to restrict the mobility of the wearer as little as possible.
  • the direct current is converted in an oscillator 32 in such a way that the amplitude remains constant.
  • the current is then introduced into the body through the wearer's skin so that the flow of current can be determined through the limb rather than the skin.
  • the compression effect is also indicated by arrows 40.
  • the output of both current and electrical voltage is also measured.
  • the evaluation device bears the reference number 50. This is also shown in particular in FIG. 4, where both the current measurement I and the voltage measurement U are symbolized. This can be used to determine the bioimpedance through the limb.
  • FIG. 4 shows a bandage or bandage according to the invention applied to a leg of a wearer, which is used synonymously in the context of the application, in which a first 20 and a second 22 end section are woven
  • Electrodes 12, 14, 16, 18 are provided, each end section 20 having two electrodes 12, 14, 16, 18 and each of these forming a pair with an electrode 12-18 of the other end section 22.
  • the control or the introduction of current into the electrodes 12-18 takes place by means of electrically conductive threads 24, 26 which are woven into the bandage / bandage.
  • the woven electrodes 12-18 also consist of electrically conductive threads.
  • the end sections 20, 22 are one or both formed from an inelastic fabric, the intermediate section 28 arranged between them being designed to be elastically stretchable and thus at the same time allowing use not only as a measuring device but also as a compression means.
  • the threads 24, 26 are woven in in such a way that the elasticity is not impaired.
  • a coating can be provided to compensate for irregularities in the area of the electrodes to be provided.
  • This can consist of an electrically conductive silicone or a graphite paste or comprise these. In this way, the contact area with the wearer's body is increased.
  • the distance d between the electrodes of an end section 20, 22 is at least 5 cm.
  • the warp thread direction preferably corresponds to the longitudinal direction of the napkin and the weft thread direction to the transverse extent of the napkin.
  • the inelastic end sections 20, 22 can be made inelastic after a design via a coating, special thread selection or by the technical variation Tv.
  • FIG. 6 once again shows the result of the test.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Vascular Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne un appareil (10) de surveillance de la thérapie par compression fournie par un moyen de compression, l'appareil comprenant un dispositif de mesure constitué d'un matériau textile destiné à être placé sur un porteur et ayant deux parties d'extrémité (20, 22) qui renferment entre elles une partie centrale (28), deux électrodes (12-18) sont disposées dans chaque partie d'extrémité (20, 22) et forment chacune une paire d'électrodes avec une électrode (12-18) de l'autre partie d'extrémité (20, 22), une paire d'électrodes déterminant un flux de courant électrique et l'autre paire d'électrodes déterminant une tension électrique entre les électrodes (12-18) d'une paire, les électrodes (12-18) étant conçues de telle sorte que, lorsque le dispositif de mesure est placé sur un porteur, le courant électrique entre les électrodes (12-18) d'une paire circule à travers le corps de l'utilisateur sous la peau. Selon l'invention, la thérapie par compression est surveillée par surveillance, par détermination de l'impédance, de la diminution du liquide dans les tissus qui sont traités par la compression.
EP20808056.4A 2019-12-16 2020-11-16 Appareil de surveillance de la thérapie par compression fournie par un moyen de compression Pending EP4076170A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019134538.3A DE102019134538A1 (de) 2019-12-16 2019-12-16 Vorrichtung zur Überwachung der Kompressionstherapie eines Kompressionsmittels
PCT/EP2020/082177 WO2021121816A1 (fr) 2019-12-16 2020-11-16 Appareil de surveillance de la thérapie par compression fournie par un moyen de compression

Publications (1)

Publication Number Publication Date
EP4076170A1 true EP4076170A1 (fr) 2022-10-26

Family

ID=73455691

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20808056.4A Pending EP4076170A1 (fr) 2019-12-16 2020-11-16 Appareil de surveillance de la thérapie par compression fournie par un moyen de compression

Country Status (4)

Country Link
US (1) US20230035112A1 (fr)
EP (1) EP4076170A1 (fr)
DE (1) DE102019134538A1 (fr)
WO (1) WO2021121816A1 (fr)

Citations (1)

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US20060052678A1 (en) * 2004-09-02 2006-03-09 Drinan Darrel D Monitoring platform for wound and ulcer monitoring and detection

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WO2009114678A1 (fr) * 2008-03-13 2009-09-17 Carolon Company Système de surveillance et de gestion de la santé
US10362968B2 (en) * 2010-10-15 2019-07-30 Fresenius Medical Care Holdings, Inc. Bioimpedance circumference measurement
EP2627248A4 (fr) * 2010-10-15 2017-11-29 Fresenius Medical Care Holdings, Inc. Prédicteur de poids sec
US10932720B2 (en) * 2011-03-08 2021-03-02 Nanowear Inc. Smart materials, dry textile sensors, and electronics integration in clothing, bed sheets, and pillow cases for neurological, cardiac and/or pulmonary monitoring
JP2013132325A (ja) * 2011-12-26 2013-07-08 Tanita Corp 生体インピーダンス測定装置及び生体インピーダンス測定方法
WO2013188871A1 (fr) * 2012-06-15 2013-12-19 Case Western Reserve University Brassard implantable et procédé de surveillance et stimulation électrique fonctionnelle
US10945663B2 (en) * 2014-11-04 2021-03-16 North Carolina State University Smart sensing systems and related methods
CA2978277A1 (fr) * 2014-11-05 2016-05-12 The Regents Of The University Of California Systeme de detection portable de telemedecine pour la gestion de troubles veineux chroniques
WO2017007518A1 (fr) * 2015-07-07 2017-01-12 Obma Padraic R Dispositif, système et procédé de surveillance médicale non invasive
US10182728B2 (en) * 2016-06-22 2019-01-22 Qualcomm Incorporated Multi-sensor device and method of using multi-sensor device for determining biometric properties of a subject
EP3621564A4 (fr) * 2017-05-10 2021-02-17 Northwestern University Dispositifs de type tissus fonctionnels comportant des capteurs intégrés
GB201710807D0 (en) 2017-07-05 2017-08-16 Rosnes Ltd Self-monitoring supports

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US20060052678A1 (en) * 2004-09-02 2006-03-09 Drinan Darrel D Monitoring platform for wound and ulcer monitoring and detection

Also Published As

Publication number Publication date
WO2021121816A1 (fr) 2021-06-24
US20230035112A1 (en) 2023-02-02
DE102019134538A1 (de) 2021-06-17

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