Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G7/00—Beds specially adapted for nursing; Devices for lifting patients or disabled persons
  • A61G7/05—Parts, details or accessories of beds
  • A61G7/057—Arrangements for preventing bed-sores or for supporting patients with burns, e.g. mattresses specially adapted therefor
• • 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
• • 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
  • A61B5/0531—Measuring skin impedance
• • 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
  • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/1036—Measuring load distribution, e.g. podologic studies
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
  • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
  • A61B5/447—Skin evaluation, e.g. for skin disorder diagnosis specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
• • 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
  • A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
  • A61B5/6892—Mats
• • 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
  • A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
  • A61B5/6894—Wheel chairs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
  • A61B5/7271—Specific aspects of physiological measurement analysis
  • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G5/00—Chairs or personal conveyances specially adapted for patients or disabled persons, e.g. wheelchairs
  • A61G5/10—Parts, details or accessories
  • A61G5/1043—Cushions specially adapted for wheelchairs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G5/00—Chairs or personal conveyances specially adapted for patients or disabled persons, e.g. wheelchairs
  • A61G5/10—Parts, details or accessories
  • A61G5/1043—Cushions specially adapted for wheelchairs
  • A61G5/1045—Cushions specially adapted for wheelchairs for the seat portion
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G2203/00—General characteristics of devices
  • A61G2203/30—General characteristics of devices characterised by sensor means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G2203/00—General characteristics of devices
  • A61G2203/30—General characteristics of devices characterised by sensor means
  • A61G2203/34—General characteristics of devices characterised by sensor means for pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G2203/00—General characteristics of devices
  • A61G2203/30—General characteristics of devices characterised by sensor means
  • A61G2203/46—General characteristics of devices characterised by sensor means for temperature
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G7/00—Beds specially adapted for nursing; Devices for lifting patients or disabled persons
  • A61G7/05—Parts, details or accessories of beds
  • A61G7/057—Arrangements for preventing bed-sores or for supporting patients with burns, e.g. mattresses specially adapted therefor
  • A61G7/05769—Arrangements for preventing bed-sores or for supporting patients with burns, e.g. mattresses specially adapted therefor with inflatable chambers

Definitions

• the object of the present invention is to provide a system for controlling the risks of appearance of pressure ulcers which comprises, in addition to pressure sensors distributed across the user' s bearing surface, respective sensing means that measure
• Another object of the present application is to provide a process for controlling the risks of
• patent document WO 2007106040 published on September 20, 2007, discloses a monitoring device for reducing the risk of pressure ulcers, which comprises a series of pressure sensors distributed across the user's seating surface, wherein the seating pressure, as well as its duration, are continuously monitored for each measurement point. If the pressure in any of the measurement points is sufficiently high to cause a decrease in the user' s blood flow, an alarm will be triggered before said lack of flow starts causing lesions to the user. Once the alarm is triggered, the user must change his seating position, relieving the overloaded area for enough time to allow the blood to flow again through the veins in said area, said relief time also being monitored by the device. Likewise, the alarm indicates where and when the pressure overload is about to take place and stops temporarily once the pressure is relieved. Not only is the user warned, but it is also possible to warn his caregivers e.g. if the user has not changed his position.
• a control system for pressure ulcer prevention is known from patent document US 2011245732, published on June 6, 2011.
• the system includes a number of force sensors positioned at different locations in relation to the contact surface, and a controller which receives the pressure values measured by each force sensor.
• the controller is configured to compare one or more first values associated with a first subset of force sensors with one or more second values associated with a second subset of force sensors, and to determine, from the comparison, whether a threshold between said one or more first values and said one or more second values have been exceeded, and to control, on the basis of the determination, an indicator to provide the user with an indication.
• electrostimulating lingual device for conveying the aforementioned motion instructions to the person; and actuators, which can be driven by the person in the seated or laid-down position, which regulate the motion of said person.
• the previously discussed solutions have a drawback in that they only take into account the increase in pressure in the area at risk as an indicator for determining the presence of the risk of appearance of pressure ulcers, on the basis of the comparison of said experienced pressure increase with a threshold which is supposedly valid for all users.
• the actual state of the tissue of the area at risk of the user' s body is not taken into consideration, which may mean that, for a given user, there might be risks of appearance of pressure ulcers before the preset
• the present invention relates to a system for controlling the risks of appearance of pressure ulcers in a user.
• the system comprises a number of pressure sensors which measure pressure values across a bearing surface of the user formed e.g. on top of a cushion.
• the term "cushion” should be understood in its widest sense, and includes cushions, pillows, etc., e.g. those used as a seat in wheelchairs, bed mattresses, etc .
• the system comprises a controller, which receives the pressure values measured by the pressure sensors, and means which act on the user, which can be driven by the controller.
• the system comprises means for sensing the state of the skin tissue in a area at risk of the user' s body which is in contact with the bearing surface, said area at risk depending on the user's posture and being in general any part of the user which has a bone protrusion exerting pressure on the skin, e.g. if he is seated it would be the ischium or the coccyx, if he is laying down it would be the heels, the head, etc.
• Said means measure respective values of bioimpedance, temperature and moisture, which are useful indicators for diagnosing the current state of the skin tissue in said area at risk.
• Bioimpedance means impedance spectroscopy, the set of impedance measurements (resistance, reactance and phase) inside a frequency range, usually the beta band ranging from 1 kHz to 1 MHz, preferably from 10 kHz to 50 kHz.
• the controller receives said values and assesses a level of risk of appearance of pressure ulcers on the basis of the measured pressure,
• the invention relates to a process for controlling the risks of appearance of pressure ulcers in a user comprising the following steps: a) setting initial pressure, bioimpedance,
• step b) calculating the variation experienced, in a certain time, by the pressure, bioimpedance, temperature and moisture values measured in the area at risk in relation to the initial pressure, bioimpedance, temperature and moisture values set in step a) ,
• step b) comparing the variations calculated in step b) with previously defined, healthy pressure, bioimpedance, temperature and moisture thresholds ,
• step d) assessing the level of risk of appearance of ulcers in the area at risk according to the results of the comparison made in step c) , and
• step e) recommending driving means which act on the user according to the risk level assessed in step d) , the user' s preferences and the scenario.
• the proposed invention allows the level of risk actually existing in the user' s skin of appearance of pressure ulcers to be assessed since, in order to do so, in addition to the increase in pressure, the particular state of the user's skin tissues in said area is taken into account through the variation of the bioimpedance, or bioelectrical
• Figure 1 depicts an interaction diagram of the system for controlling risks of appearance of pressure ulcers .
• Figure 2 depicts an example of a preferred embodiment of the system shown in Figure 1, as part of a wheelchair and a garment in the shape of short pants.
• the present invention is a system for
• the system comprises a number of pressure sensors (1) distributed across a bearing surface (2) of the user (not shown in the figures) , which measure the pressure values (P) .
• the pressure sensors (1) are arranged forming a matrix covering the entire bearing surface (2) .
• the bearing surface (2) is formed on a dynamic cushion (6) having independent
• FIG. 1 shows that the dynamic cushion (6) is a seat (7.1) of a wheelchair (7); however, it could be the mattress (not shown in the figures) of an articulated hospital bed (not shown in the figures) .
• the system comprises a controller which receives the pressure values measured by the pressure sensors (1), and means (4) which act on the user, which can be driven by the controller (3) .
• the controller (3) can be configured from an interface, which comprises a user application, or "app", on a mobile device (9) belonging to any of the known types: mobile phone, smartphone, tablet, etc.
• the system comprises tissue- state sensing means (5) , which measure bioimpedance, temperature and moisture values (Z) , (T) and (Hr) in an area at risk (PU) of the user's body which is in contact with the bearing surface (2) .
• tissue- state sensing means (5) which measure bioimpedance, temperature and moisture values (Z) , (T) and (Hr) in an area at risk (PU) of the user's body which is in contact with the bearing surface (2) .
• these values (Z) , (T) and (Hr) are received by the controller (3) , which assesses a level of risk of appearance of pressure ulcers on the basis of said pressure,
• the tissue-state sensing means (5) are arranged on the garment (8) that is attached to the user's body.
• said garment (8) is shown in the shape of short pants in Figure 2.
• both the tissue-state sensing means (5) and the functional electrical stimulation means (8.1) present in the garment (8) preferably communicate with the controller (3) via cable or wirelessly.
• the pressure sensors (1) and the tissue- state sensing means (5) start performing a continuous sampling with a frequency of e.g. at least 0.1 Hz.
• the pressure thresholds considered to be healthy are calculated by adding a "safety" margin to the critical pressure values leading to the
• Said thresholds are:
• the pressure (P) does not increase between 187 mmHg (Prl) and 225 mmHg (Pr2) for more than two minutes, it being possible for it to stay the same for a time (t) of one hour, - the pressure (P) does not increase between
• the healthy threshold preferably does not increase by 5 to 30% in relation to the set initial value (Zb) . It is considered that there might be risks of appearance of pressure ulcers in this range. In particular, damage to the tissue, or cellular death, starts from 30%.
• the healthy thresholds are preferably the following:
• the temperature (T) is between 27 and 36°C
• the moisture (Hr) is below 80%.
• the level of risk of appearance of ulcers in the area at risk is assessed according to the results of the comparison made before.
• four risk levels are identified: “no risk”, “low risk”, “average risk” and “high risk”.
• the risk level can be assessed as being zero if all the following conditions are fulfilled:
• the bioimpedance (Z) increases by less than > o ,
• the risk level can be assessed as being low if at least one of the following conditions is fulfilled:
• the bioimpedance (Z) increases by 5 to 10%, the pressure (P) stays between Prl and Pr2 in the time (t) ,
• the temperature (T) stays between 27 and 29°C and the moisture (Hr) stays below 90%, the temperature (T) stays between 29 and 34°C and the moisture (Hr) stays between 80 and 90%, or
• the temperature (T) stays between 34 and 36°C and the moisture (Hr) stays below 90%.
• the risk level can be assessed as being average if at least one of the following conditions is
• the risk level can be assessed as being high if at least one of the following conditions is fulfilled:
• the bioimpedance (Z) increases by 10 to 20%. Then, depending on the assessed risk level, it is advisable to drive the means (4) which act on the user according to a strategy for driving them. The user may follow the recommendation or ignore it, usually via the application of the interface of the mobile device (9) .
• a series of strategies for driving the actuating means (4) are programmed according to the types of risks, the scenarios, i.e. the positions adopted by the user as a result of the action of the reclining means (7.2), e.g. a seated position,
• the actuating means will follow the drive strategy until the risk level changes.
• the variation experienced by the pressure, bioimpedance, temperature and moisture values (P) , (Z) , (T) and (Hr) is continuously calculated until the user exits the system; said variation is continuously compared with the healthy thresholds; and the real risk level existing in the area at risk (PU) is continuously assessed.
• the actuating means (4) will move on to carry out another strategy according to the new risk level that has been reached.
• control areas (6.1) of the dynamic cushion (6) those touching the user's right or left ischium can be programmed to
• the maximum reclining positions with or without the presence of risks, and those harmful to or uncomfortable for the user, i.e. those which can affect the user's daily activities, are identified according to the type of scenario.
• the functional electrical stimulation means (8.1) can be programmed for different frequency levels, pulse durations, application times and rest intervals, as well as the current to be applied. The latter can also be adjusted by the professional in charge of each user.
• the emission of sound and/or visual signals can also be programmed to take place at different moments of the process, e.g. when a high risk level has been reached and it has not been resolved in less than 15 minutes. These signals can be aimed at attracting the attention of either the user or the professional in charge of him. Thus, different strategies to be used depending on the different risk levels that are reached and the scenarios in which the user is positioned are
• an automatic mode can be programmed, which will be
• the dynamic cushion (6) and the functional electrical stimulation means (8.1) which could be applied e.g. every 10 minutes during situations in which the risk level is assessed as being zero.
• the specific order of the strategies for each risk level and scenario combination may be modified during their application according to the user's preferences.
• the professional in charge may command the strategies so as to adapt them to the characteristics of each user. For example, the user in question may not tolerate the functional electrical stimulation due to his suffering spasm episodes, and the professional may adjust the pressure of the dynamic cushion (6) and the angles of the reclining means (7.2) of the wheelchair (7) based on his experience.

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• 2015
  • 2015-08-21 EP EP15759692.5A patent/EP3337436A1/de not_active Withdrawn
  • 2015-08-21 WO PCT/EP2015/069245 patent/WO2017032393A1/en active Application Filing

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