WO2021220238A1 - Procédé et dispositif de détermination d'une température plantaire d'un pied - Google Patents

Procédé et dispositif de détermination d'une température plantaire d'un pied Download PDF

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Publication number
WO2021220238A1
WO2021220238A1 PCT/IB2021/053626 IB2021053626W WO2021220238A1 WO 2021220238 A1 WO2021220238 A1 WO 2021220238A1 IB 2021053626 W IB2021053626 W IB 2021053626W WO 2021220238 A1 WO2021220238 A1 WO 2021220238A1
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WO
WIPO (PCT)
Prior art keywords
temperature
determination
foot
feet
plantar
Prior art date
Application number
PCT/IB2021/053626
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English (en)
Inventor
Anuj Ambrish SHAHADE
Arati Ambrish SHAHADE
Shounak Shrikrishna OZARKAR
Original Assignee
Shahade Anuj Ambrish
Shahade Arati Ambrish
Ozarkar Shounak Shrikrishna
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 Shahade Anuj Ambrish, Shahade Arati Ambrish, Ozarkar Shounak Shrikrishna filed Critical Shahade Anuj Ambrish
Publication of WO2021220238A1 publication Critical patent/WO2021220238A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A61B5/015—By temperature mapping of body part
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle

Definitions

  • This invention generally relates to the field of preemptive care in diabetes afflicted individuals. More particularly, the present invention relates to a device, and it’s implementing method, whereby plantar foot temperatures of diabetes afflicted individuals can be accurately mapped to identify predisposition and / or early onset of ulcerous foot and / or Charcot’s foot.
  • TLC shall refer Thermochromic Liquid Crystals, which are heat-sensitive and have the property of exhibiting different colors, when visualized against a black background, indicative of the temperature of an object placed there-against;
  • Diabetic Foot and “ulcerous foot” are used synonymously for each other in this document, and refer a foot that exhibits any pathology that results directly from diabetes mellitus or any long-term complication of diabetes mellitus;
  • PCB refers a printed circuit board
  • processor refers micro controllers (Arduino or other) other processor types and their equivalents;
  • MQTT refers Message Queuing Telemetry Transport. BACKGROUND OF THE INVENTION AND DESCRIPTION OF PRIOR ART
  • Diabetes is a group of metabolic disorders characterized by a high blood sugar level over a prolonged period of time ("About diabetes”. World Health Organization). If left untreated, diabetes can lead to many serious long-term complications including diabetic keto-acidosis, hyper osmolar hyperglycemic state, cardiovascular disease, stroke, chronic kidney disease, foot ulcers, damage to the nerves, damage to the eyes, or even death ("Diabetes Fact sheet N°312". WHO). Hence there is a global demand for newer and better means of achieving reliable management of diabetes.
  • thermography has been identified in state of the art as a potential diagnostic tool in determining the predisposition and / or early onslaught of diabetic / insensate foot in diabetic patients.
  • US8360987B2 (issued to Scott Kantro) discloses a console for measuring plantar foot pressure includes a support case and at least two temperature sensitive pads, disposed in the case, configured to allow a user to measure the temperature of the soles of their feet without assistance.
  • US9095305B2 (assigned to Podimetrics Inc) which teaches a method of monitoring a patient's foot provides an open platform for receiving at least one foot.
  • the platform has at least one temperature sensor for generating a plurality of temperature data values after receipt of the at least one foot.
  • the method then forms a thermogram of the sole of the at least one foot from the temperature data, and determines whether the thermogram presents at least one of a plurality of prescribed patterns.
  • the method produces output information indicating the emergence of a pre-ulcer or progression of a known pre-ulcer in the at least one foot as a function of whether the thermogram is determined to present the at least one pattern.
  • FIGURE 1 is a schematic isometric view of the device of the present invention.
  • FIGURE 2 is a schematic sectional view of the device of the present invention.
  • FIGURE 3 is a block diagram to explain operational logic of the present invention.
  • FIGURE 4A is a graph sselling results of comparative study 1 , wherein a peer device is used for temperature measurements.
  • FIGURE 4B is a graph sselling results of comparative study 1 , wherein the device of the present invention is used for temperature measurements.
  • FIGURE 5A is a graph sselling results of comparative study 1 , wherein the device of the present invention is used for temperature measurements.
  • FIGURE 5B is a graph sselling results of comparative study 1 , wherein a peer device is used for temperature measurements.
  • the present invention is directed toward a simple and cost effective device to identify predisposition and / or early onset of foot complications in diabetes patients.
  • Said device comprises an enclosure having its top-side surface inclined at an angle of 30° which is provisioned with sensitive temperature sensors at strategic locations for automatic temperature measurement at said positions whenever the user places his / her foot / feet onto the foot template / outline provided on said top-side surface.
  • the present invention is directed at absorbing all advantages of prior art while overcoming, and not imbibing, any of its shortfalls, to thereby establish a simple and cost effective device, and it’s implementing method, whereby plantar foot temperatures of diabetes afflicted individuals can be accurately mapped to identify predisposition and / or early onset of foot complications in diabetes patients.
  • said base module is essentially a hollow enclosure / box (01) having its top-side surface (02) inclined at an angle of 30° with respect to the base (03) of said hollow box (01).
  • This geometry allows the box to be placed flush on its base (03) atop a flat / ground surface, therein disposing the inclined surface (02) for placement of feet by the diabetic patient for determination of plantar temperature as will be disclosed further in this document.
  • an outline / map of a pair of feet (03a and 03b) and heel-rests (04a and 04b) are provided on the inclined surface (02) for allowing precise placement of feet by the diabetic patient.
  • Seven sensitive temperature sensors (represented by the common numeral 05) are disposed in each of the outline / map of pair of feet (03a and 03b), therein protruding 2 mm above the outline / map (03a and 03b), for determination of plantar temperature, when feet of the diabetic patient are placed within the outline / map (03a and 03b) atop the inclined surface (02).
  • the hollow box (01) is made from suitably rigid material chosen among wood and / or 3D-printing composites and their combinations, and is made durable enough to bear the weight of the average human being.
  • the seven sensitive temperature sensors are designated, and so disposed at co-planar coordinates within the zones (03a and 03b) atop the inclined surface (02), so as to allow each sensor to independently measure temperature at the following sites- a) Great toe b) First metatarsophalangeal joint c) Mid fore foot d) 5 th metatarsophalangeal joint e) Lateral arch f) Medial to medial arch g) Heel
  • the temperature sensors (05 identified as a) to g) as above) are DS18B20 which have an accuracy of 0.05°C and measuring the temperature within -55 °C to +125 °C.
  • the temperature sensors (05 identified as a) to g) as above) are connected, via independent lead cables (represented by common numeral 06) to a PCB (07) placed within the hollow box (01).
  • a processor (08) is provided on the PCB (07), a ESP8266 SoC (System on Chip) in particular, for execution of logic necessary for logging and interpretation of signals received from the temperature sensors (05 identified as a) to g) as above).
  • a power cable (09) is provided traversing the hollow box (01) for connecting the PCB (07) to an external source of utility power (not shown in the drawing).
  • the device proposed herein may be provisioned to have batteries on-board within the enclosure (01) to thereby source electrical power required for operating the device disclosed herein.
  • the plantar temperature data of a patient is relayed, via the low latency MQTT protocol, first to a mobile phone belonging to the patient or caregiver, and from there, secondly to a remote server belonging to a healthcare facility (for example a hospital, doctor’s clinic and the like) whereby expert personnel can monitor, ideally in real time, and prescribe / take suitable actions should the readings for any patient be beyond the thresholds normally expected.
  • a healthcare facility for example a hospital, doctor’s clinic and the like
  • a cloud server is intended, in yet another embodiment, whereby plantar temperature data of a patient can be uploaded in real time for aforementioned analysis and action. It shall be understood that this system can be configured to take / convey plantar temperature data of a patient continuously Or at predetermined time intervals as may be desired.
  • thermograms Once data is available, it is parsed by conventional algorithms for establishment of thermograms and their differential diagnosis to determine incidence of ischemic or inflammatory processes, indicative of predisposition / early onslaught of diabetic foot.
  • the device also helps in localizing where the issue lies to prevent any future complications, which in the given case is in 1st metatarsophalangeal joint and lateral arch.
  • Table 2 doesn’t provide conclusive evidence as it is the median of all diabetic patients with foot issues, however, compared to readings of Table 4 a large variation can be seen in the temperature ranges and higher foot temperatures can be noted.
  • Table 3 Diabetic patients without a foot problem
  • the data in Table 3 consists of the readings from diabetic patients without a foot problem and it acts as a point of reference with respect to the readings for diabetic patients having foot problems.
  • Table 4 consists of the readings from patients without diabetes and it acts as a point of reference with respect to the readings for diabetic patients.
  • Table 5 gives an overall range of temperature amongst the entire group of patients, as under-
  • the toe region readings are compared of diabetic patients.
  • the difference between the left and right toe for the peer device and the device of the present invention are as shown in FIGURE 4A and FIGURE 4B respectively.
  • the results show that the device of the present invention, when compared to the peer device, shows a more consistent data measurement with lesser spread of data which speaks of improved precision and confidence of temperature measured to be used by healthcare professionals for interpretative analysis.
  • the readings with a difference of 4+ °C would mean, when not necessarily the case, that the patient has heavy diabetes and might have problems with blood circulation or need amputation. This false positive result is not seen in the device of the present invention.
  • the difference in readings might be due to either or both among measurement of wrong reading by the peer (Infrared) device and / or observer error in reading temperature. Both of these eventualities are avoided in the device of the present invention, as the temperature readings are logged automatically and / or displayed directly on the screen.
  • wrong reading from the peer (infrared) device may be due to two reasons, one of them being not holding the thermometer at a proper distance or using them in unclean environments. The environment and the distance doesn’t affect the readings in the present invention, hence avoiding the possibility of wrong readings in the inventive device taught herein.
  • the inaccuracy of peer (infrared) devices is well documented phenomena, thus cannot be reliable over sensors which are measuring by complete contact with the precise point / position where temperature needs to be measured. It is intended for the present invention to progress into related embodiments wherein temperature and pressure are attributes being mapped to identify predisposition and / or early onset of foot complications (such as ulcerous foot and others) in diabetic patients.
  • the reduction to practice may embody footwear with in-built sensors which allow the logging of temperature and / or pressure data while the patient is going about his / her normal chores, that is regularly and without causing as fewer disruptions in life as possible and that too, outside hospital settings, even at home.
  • the subject chosen is a male patient of age 58 years, with an 8 year history of diabetes but no amputation.
  • First metatarsal temperature was logged using the device of the present invention over an extended period (in days).
  • the subject chosen is a male patient of 56 years age, with a 7 year history of diabetes and amputation.
  • First metatarsal temperature was logged using the peer device (handheld infrared skin thermometer) over an extended period (in days).
  • FIGURE 5A and FIGURE 5B the patients maintain a consistent temperature pattern throughout the period as seen in the graphs and did not experience any foot complication in that duration.
  • the data for proposed device has been taken at the same position of 1st metatarsal, wherein it was seen that The temperature difference did go above 2.2 °C for the peer device but did not stay at that level, the same is observed in FIGURE 5B.
  • FIGURE 5A in which study the device hereof was used, clearly shows a difference of more than 2.2 °C for a person suffering with diabetic foot problem and it is in arch and 1 st metatarsal region of the foot as recorded by the device. This aids the doctor in treating specific area and prevent further ulceration or pain for the patient. It can be concluded with this that the novel device design proposed herein helps in identifying the location where the problem exactly lies on the foot as compared to the devices that are conventionally used / available in the field of this invention.
  • FIGURE 5B the temperature difference between the first metatarsal of right and left feet for 1 st metatarsal. Measurements that are above the 4°F “boundary” limit at the top of the graph represent higher temperatures on the right foot, and measurements beyond the lower “boundary” represent higher temperatures on the left foot.
  • LCT device that requires contact with foot
  • thermographic images which can be hard to interpret, whereas the device proposed provides digitally readable data which can be easily interpreted by lay-man
  • LCT devices also require pre-defined time for reading the temperature otherwise it might lead to contamination of data, this is not the case when sensors are used as it does not lead to data contamination;
  • the inventors named herein are of the belief that use of the device proposed herein shall assuredly help in not only curbing the incidence of diabetic foot but also the good habits inculcated could help in preventing the development of other disease- associated complications. Accordingly, use of the device proposed herein at home monitoring can reduce foot ulcers and further complications in >60% cases, which can be achieved with the proposed device. No advanced image processing techniques are required making the device considerably cost effective and robust for daily use.
  • an able device, and it’s implementing method, whereby plantar foot temperatures of diabetes afflicted individuals can be accurately mapped to identify predisposition and / or early onset of foot complications (including ulcerous foot) is thus provided with improved functionality, durability and long service life than any of its closest peers in state-of-art.

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

Dispositif simple et économique permettant d'identifier la prédisposition et/ou l'apparition précoce de complications au pied chez des patients diabétiques. Ledit dispositif comprend une enceinte ayant sa surface supérieure-latérale inclinée sous un angle de 30° qui est pourvue de capteurs de température sensibles à des localisations stratégiques permettant la mesure automatique de température au niveau desdites positions quel que soit l'endroit où l'utilisateur place son/ses pieds/sur le modèle/le contour de pied fourni sur ladite surface supérieure-latérale.
PCT/IB2021/053626 2020-04-30 2021-04-30 Procédé et dispositif de détermination d'une température plantaire d'un pied WO2021220238A1 (fr)

Applications Claiming Priority (2)

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IN202021013918 2020-04-30
IN202021013918 2020-04-30

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WO2021220238A1 true WO2021220238A1 (fr) 2021-11-04

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6767330B2 (en) * 2000-05-25 2004-07-27 Salix Medical, Inc. Foot temperature and health monitoring system
EP1511419A1 (fr) * 2002-06-12 2005-03-09 Medavinci Development B.V. Dispositif et procede d'examen de pied de diabetique
DE102014008091A1 (de) * 2014-06-02 2015-12-03 automation & software Günther Tausch GmbH Vorrichtung zur Erfassung von Druckbelastungen und/oder Temperaturdifferenzen für den diabetischen Fuß

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6767330B2 (en) * 2000-05-25 2004-07-27 Salix Medical, Inc. Foot temperature and health monitoring system
EP1511419A1 (fr) * 2002-06-12 2005-03-09 Medavinci Development B.V. Dispositif et procede d'examen de pied de diabetique
DE102014008091A1 (de) * 2014-06-02 2015-12-03 automation & software Günther Tausch GmbH Vorrichtung zur Erfassung von Druckbelastungen und/oder Temperaturdifferenzen für den diabetischen Fuß

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