WO2019159195A1 - Dispositif de dépistage d'un pied diabétique - Google Patents
Dispositif de dépistage d'un pied diabétique Download PDFInfo
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- WO2019159195A1 WO2019159195A1 PCT/IN2019/050114 IN2019050114W WO2019159195A1 WO 2019159195 A1 WO2019159195 A1 WO 2019159195A1 IN 2019050114 W IN2019050114 W IN 2019050114W WO 2019159195 A1 WO2019159195 A1 WO 2019159195A1
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- Prior art keywords
- vibration
- temperature
- load
- sensor
- lvt
- Prior art date
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- 208000008960 Diabetic foot Diseases 0.000 title claims abstract description 31
- 238000012216 screening Methods 0.000 title claims abstract description 17
- 230000036982 action potential Effects 0.000 claims abstract description 48
- 230000008859 change Effects 0.000 claims abstract description 47
- 230000007830 nerve conduction Effects 0.000 claims abstract description 28
- 230000007246 mechanism Effects 0.000 claims abstract description 14
- 238000006073 displacement reaction Methods 0.000 claims description 19
- 238000012545 processing Methods 0.000 claims description 16
- 230000008447 perception Effects 0.000 claims description 15
- 238000007373 indentation Methods 0.000 claims description 12
- 238000004891 communication Methods 0.000 claims description 10
- 230000009471 action Effects 0.000 claims description 7
- 210000001519 tissue Anatomy 0.000 description 15
- 206010012601 diabetes mellitus Diseases 0.000 description 11
- 238000000034 method Methods 0.000 description 11
- 201000001119 neuropathy Diseases 0.000 description 10
- 230000007823 neuropathy Effects 0.000 description 10
- 208000033808 peripheral neuropathy Diseases 0.000 description 10
- 230000004044 response Effects 0.000 description 8
- 230000035807 sensation Effects 0.000 description 6
- 208000025865 Ulcer Diseases 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 5
- 210000005036 nerve Anatomy 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 231100000397 ulcer Toxicity 0.000 description 5
- 238000012360 testing method Methods 0.000 description 4
- 208000027418 Wounds and injury Diseases 0.000 description 3
- 238000002266 amputation Methods 0.000 description 3
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- 230000002981 neuropathic effect Effects 0.000 description 3
- 125000002066 L-histidyl group Chemical group [H]N1C([H])=NC(C([H])([H])[C@](C(=O)[*])([H])N([H])[H])=C1[H] 0.000 description 2
- 206010050502 Neuropathic ulcer Diseases 0.000 description 2
- 206010052428 Wound Diseases 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000002405 diagnostic procedure Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- 230000015541 sensory perception of touch Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 208000032131 Diabetic Neuropathies Diseases 0.000 description 1
- 208000003790 Foot Ulcer Diseases 0.000 description 1
- 206010017711 Gangrene Diseases 0.000 description 1
- 206010057178 Osteoarthropathies Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
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- 210000003414 extremity Anatomy 0.000 description 1
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- 230000003993 interaction Effects 0.000 description 1
- 238000009533 lab test Methods 0.000 description 1
- 238000011542 limb amputation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000003141 lower extremity Anatomy 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
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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
- A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
- A61B5/0051—Detecting, measuring or recording by applying mechanical forces or stimuli by applying vibrations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
- A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
-
- 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
- A61B5/103—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
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/388—Nerve conduction study, e.g. detecting action potential of peripheral nerves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
- A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
- A61B5/4041—Evaluating nerves condition
-
- 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
- A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
-
- 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
Definitions
- This invention relates to the field of biomedical engineering.
- this invention relates to a device for screening of a diabetic foot.
- a diabetic foot is a foot that exhibits any pathology that results directly from diabetes mellitus or any long-term (or "chronic") complication of diabetes mellitus. Presence of several characteristic diabetic foot pathologies such as infection, diabetic foot ulcer and neuropathic osteoarthropathy is called diabetic foot syndrome.
- diabetic neuropathy Due to the peripheral nerve dysfunction associated with diabetes (diabetic neuropathy), patients have a reduced ability to feel pain. This means that minor injuries may remain undiscovered for a long while. People with diabetes are also at risk of developing a diabetic foot ulcer. Research estimates that the lifetime incidence of foot ulcers within the diabetic community is around 15% and may become as high as 25%.
- Diabetes cost a whopping USD 548 billion in health expenditure globally in 2014.
- DFU treatment is expensive and it becomes untreatable especially if not detected at earlier stage.
- the treatment cost for early wounds in developed countries was USD 3096 in 2010. However, if the wound becomes complicated and amputated, the cost rises to almost USD 107900.
- Prior art diagnostic methods include checking patients sensing of touch, vibration and temperature stimuli applied to their foot sole. These tests require patients response for evaluating parameters and therefore inaccurate. Prior art devices doing these tests are discrete in nature i.e. one stimuli per device. So it takes more time - approximately 15 to 30 minutes per person for single parameter evaluation - and more human effort for single patient. Devices or Lab Tests which are non- subjective like Ankle-Brachial Index Test (ABI) or Vascular Screening are very costly and not available with many of the podiatrists and general hospitals. Also to operate these devices, skilled staff is required and generate results which only Doctors or highly trained staff can analyze. While organising camps in rural area, in addition to lack of funds and highly trained staff, portability of these devices is also a big problem.
- An object of the invention is to provide a device focused towards early screening of diabetic patients who are susceptible to diabetic foot neuropathic ulcers.
- Another object of the invention is to provide a device provides an objective analysis aimed towards detecting onset of diabetic foot ulcers.
- Yet another object of the invention is to provide a device provides an objective analysis aimed towards detecting onset of diabetic foot ulcers; the objective analysis comprising a simultaneous reading of touch, vibration, and temperature of a patient’s foot.
- Still another object of the invention is to provide a device which overcomes the prior art limitations, and enables automatic, accurate and rapid evaluation of diabetic foot neuropathy.
- a device for screening of a diabetic foot comprising:
- a displaceable plate moving towards and away from a parallely spaced apart operative top plate, said movement being actuated by an indenting mechanism, said displaceable plate, in a first configuration of working of this device, configured to host an array of dummy units configured to exert and record pressure against a user’ s skin surface when said displaceable unit is moved towards a skin of a user in contact with said operative top plate in order to determine high pressure points of said skin and thereby determine corresponding dummy units corresponding to said determined high pressure points in order to replace said determined dummy units with load-vibration-temperature units, when said displaceable plate is moved away from said operative top plate so that, in a second configuration of working of this device, said displaceable plate is configured to exert change in pressure, vibration, and temperature, through said load-vibration- temperature units, when said displaceable unit is once again moved towards a skin of a user in contact with said operative top plate in order to record action potential signals as a consequence of change of each of pressure, vibration
- said displaceable plate is configured to host a pressure pad on its operative top surface from which a plurality of dummy units, in a first configuration of working of said device, extend out in an operative vertically upward direction in order to determine high pressure points on a user’s skin surface, and said pressure pad further configured to host load-vibration- temperature units by removing dummy units corresponding to said determined high pressure points.
- said operative top plate comprising an array of guiding holes configured to guide linear displacement of said dummy units, in this device’s first working configuration, and then to guide linear displacement of said load-vibration- temperature units, in this device’s second working configuration.
- said indenting mechanism configured to linearly displace said displaceable plate in an operative vertical upward and downward direction such that said dummy units are linearly displaced through corresponding guide holes of said operative top plate, in this device’s first working configuration, and such that said load-vibration-temperature units, are linearly displaced through corresponding guide holes of the operative top plate, in this device’s second working configuration.
- said nerve conduction belt is configured with electrodes to be in contact with said user’s skin surface in order to:
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said load-vibration-temperature unit comprising a load sensor at the base of said load- vibration-temperature unit.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said load-vibration-temperature unit comprising a vibration sensor is placed operatively above, spaced apart, from said load sensor.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said load-vibration-temperature unit comprising a temperature sensor is placed operatively above, spaced apart, from said load sensor.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said load-vibration-temperature unit comprising a linear actuator configured to actuate linear displacement of said load- vibration-temperature unit against a determined point on the user’s skin surface.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said load-vibration-temperature unit comprising a load sensor senses load of a user when the user’s skin surface acts against said load sensor so that said linear actuator along with said load sensor determines plantar tissue stiffness.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said temperature actuator actuates temperature change on said user’s skin surface.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said temperature sensor senses temperature change and quantifies the change in temperature vis-a-vis action potential signal in order to determine a temperature perception threshold in communication with action potential signal from said nerve conduction belt which senses and records action potential signal consequential to temperature change.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said vibration actuator actuates vibration change on said user’s skin surface.
- said load-vibration-temperature unit comprising a load sensor, a linear actuator, a vibration actuator, a vibration sensor, a temperature actuator, and a temperature sensor, characterised in that, said vibration sensor senses vibration change and quantifies the change in vibration vis-a-vis action potential signal in order to determine a vibration perception threshold in communication with action potential signal from said nerve conduction belt which senses and records action potential signal consequential to vibration change.
- said load-vibration-temperature unit is communicably coupled to at least a control unit and at least a recording unit.
- said dummy units comprising inbuilt load sensors.
- said device comprising an input mechanism configured to control parameters relating to displacement of indentation, speed of indentation, load threshold range in order to curb indentation, temperature ranges, vibration ranges, and the like.
- said device comprising a processing unit configured to receive signals from said load-vibration-temperature units and from said nerve conduction belt.
- each dummy unit rests on a pressure sensor at its operative base, said dummy units being linearly displaceable in an operative vertical upward and downward direction.
- said pressure pad comprises an array of pressure sensors.
- said pressure pad being configured with slots such that said dummy units can be removed and replaced with load-vibration-temperature units.
- said device comprising:
- a displaceable plate configured to host a pressure pad on its operative top surface from which a plurality of dummy units, in a first configuration of working of said device, extend out in an operative vertically upward direction in order to determine high pressure points on a user’s skin surface, and said pressure pad further configured to host load-vibration-temperature units by removing dummy units corresponding to said determined high pressure points;
- an operative top plate comprising an array of guiding holes configured to guide linear displacement of said dummy units, in this device’s first working configuration, and then to guide linear displacement of said load-vibration- temperature units, in this device’s second working configuration;
- an indenting mechanism configured to linearly displace said displaceable plate in an operative vertical upward and downward direction such that said dummy units are linearly displaced through corresponding guide holes of said operative top plate, in this device’s first working configuration, and such that said load-vibration-temperature units, are linearly displaced through corresponding guide holes of the operative top plate, in this device’s second working configuration;
- a nerve conduction belt configured with electrodes to be in contact with said user’s skin surface in order to:
- FIGURE 1 illustrates a load-vibration-temperature unit along with a nerve conduction belt; both being important constituents of the device;
- FIGURE 2A illustrates pressure points of the foot in correlation with the device
- FIGURE 2B illustrates a foot placed on the device
- FIGURE 3A illustrates an isometric view of this device in its first configuration of use which utilizes dummy units only
- FIGURE 3B illustrates an isometric view of this device in its second configuration of use which utilizes the load-vibration-temperature units along with dummy units;
- FIGURE 4 illustrates a side view of the device along with a foot placed on the device
- FIGURE 5 illustrates a processing methodology using the device
- FIGURE 6 illustrates a patient with his foot placed on the device.
- a device for screening of a diabetic foot there is provided a device for screening of a diabetic foot.
- the device is primarily is used in relation to a user’ foot sole.
- the foot sole is also a user’s skin and that this device, without deviation from its construction and working principle, can be used on any other skin surface of a user if required.
- the smart diabetic foot screening device (100), of this invention integrates all three stimuli (touch, vibration, and temperature) in a single unit and automates the process, thereby making it easy to use by general practitioners and paramedics. Additionally, the smart diabetic foot screening device, of this invention, eliminates subjective responses from a patient, converting the required response-to-stimulus into device-initiated, device-monitored, and device-recorded signals which convert the réellewhile ‘doctor-patient verbal interaction dependent’ subjective data into evidential device based objective data.
- FIGURE 1 illustrates a load-vibration-temperature unit (LVT) along with a nerve conduction belt (NCB); both being important constituents of the device (100) of this invention.
- LVT load-vibration-temperature unit
- NCB nerve conduction belt
- the device (100) comprises a load- vibration-temperature unit (LVT) configured to comprise:
- VA vibration actuator
- TS temperature sensor
- This unit in accordance with its construction, comprises a load sensor (LS) at the base of the load-vibration-temperature unit (LVT).
- a vibration sensor (VS) is placed operatively above, spaced apart, from said load sensor (LS).
- a temperature sensor (TS) is placed operatively above, spaced apart, from said load sensor (LS).
- the linear actuator (LA) actuates linear displacement of the corresponding load- vibration-temperature unit (LVT) against a determined point on the sole of a patient’s foot (10a).
- a load sensor (LS) senses load of the foot of the patient.
- the linear actuator (LA) along with load sensor (LS) determines plantar tissue stiffness.
- the temperature actuator (TA) actuates temperature change on the sole of a patient’s foot (10a) and the temperature sensor (TS) senses the temperature change and quantifies the change in temperature vis-a-vis action potential signal in order to determine a temperature perception threshold in communication with action potential signal from the nerve conduction belt (NCB) which senses and records action potential signal consequential to temperature change. This data is passed on to the processing unit (PU).
- the vibration actuator (VA) actuates vibration change on the sole of a patient’s foot (10a) and the vibration sensor (VS) senses the vibration change and quantifies the change in vibration vis-a-vis action potential signal in order to determine a vibration perception threshold in communication with action potential signal from the nerve conduction belt (NCB) which senses and records action potential signal consequential to vibration change.
- This data is passed on to the processing unit (PU).
- This load-vibration-temperature unit (LVT) is communicably coupled to at least a control unit and at least a recording unit.
- the device comprises a displaceable plate (DP) configured to host a pressure pad (PP) on its operative top surface from which a plurality of dummy units (DU), in a first configuration of working of this invention, extend out in an operative vertically upward direction.
- DP displaceable plate
- PP pressure pad
- DU dummy units
- a threshold of pressure values are fed into a processing unit (PU) which receives data from each pressure sensors and based on sensed values and set threshold values, the processing unit determines which dummy units (DU) correspond with high pressure areas of a foot sole. There may be 6 pre-defined pressure points. With this data, the device’s processing unit (PU) configures additional high pressure points (over and above the defined 6 pressure points) from which data are to be captured by this device.
- the pressure pad (PP) comprises an array of pressure sensors. The pressure pad (PP) is configured with slots such that the dummy units (DU) can be removed and replaced with load- vibration-temperature units (LVT) of this invention.
- the device (100) comprises an operative top plate (TP) comprising an array of guiding holes (through holes) configured to guide linear displacement of the dummy units (DU), in its first working configuration, and then to guide linear displacement of the load-vibration- temperature units (LVT), in its second working configuration.
- TP operative top plate
- DU dummy units
- LVT load-vibration- temperature units
- the device (100) comprises an indenting mechanism (IM) configured to linearly displace the displaceable plate (DP) in an operative vertical upward and downward direction such that the dummy units (DU) are linearly displaced through corresponding guide holes (H) of the operative top plate (TP), in device’s (100) first working configuration, and such that the load-vibration-temperature units (LVT), are linearly displaced through corresponding guide holes (H) of the operative top plate (TP), in the device’s (100) second working configuration.
- IM indenting mechanism
- the indenting process allows the dummy units, in the device’s first working configuration, to exert force against the sole of a foot; high pressure areas of the foot’s sole have more resistance and therefore record a relatively higher pressure at that dummy unit’s corresponding pressure sensor (recorded at the processing unit).
- the dummy units (DU) have inbuilt load sensors. This eliminates the need for a pressure pad in the device (100) of this invention.
- FIGURE 2 illustrates pressure points of the foot (10a) in correlation with the device (100) of this invention.
- FIGURE 3 A illustrates an isometric view of this device (100) in its first configuration of use which utilizes dummy units (DU) only.
- FIGURE 3B illustrates an isometric view of this device (100) in its second configuration of use which utilizes the load-vibration-temperature (LVT) units along with dummy units (DU).
- LVT load-vibration-temperature
- DU dummy units
- FIGURE 4 illustrates a side view of the device (100) of this invention along with a foot (10a) placed on the device.
- FIGURE 5 illustrates a processing methodology using the device (100) of this invention.
- FIGURE 6 illustrates a patient (10) with his foot (10a) placed on the device (100) of this invention.
- the device (100) comprises a nerve conduction belt (NCB) configured with electrodes / contacts and is to be in contact with a user’s / patent’s body such as a portion of a limb so that it can capture nerve or muscle action potential signals.
- Action potential is the result of stimulus to receptors in skin; whenever, a stimulus is applied, the stimulus activates the receptors and generates an action potential which travels through nerves and reaches brain / spine.
- the nerve conduction belt the entire examination of a user’s / patient’s (10) foot (10a) becomes subject-free (i.e. doctor- analysis-independent and patient- analysis-independent); thereby, increasing accuracy and improving time related to readings.
- the device (100) comprises an input mechanism configured to control parameters relating to displacement of indentation, speed of indentation, load threshold range in order to curb indentation, temperature ranges, vibration ranges, and the like.
- FIGURE 5 illustrates a methodology using the device of this invention which uses three different stimuli (pressure, vibration and temperature), applies these stimuli to detect diabetic foot neuropathy.
- This device uses three different stimuli (pressure, vibration and temperature) into a single unit and applies these stimuli in a standard manner to the foot sole of (diabetic) patients; obtains the perception sensation (without the patient’s need to respond); and displays the results so that diabetic patients susceptible to foot neuropathy can be easily screened (red-danger; orange-alert; green-normal).
- the foot is then placed on an operative top platform (TP).
- the indenting mechanism (IM) pushes the top platform with load-vibration-temperature units (LVT) to indent the foot tissue.
- LVT load-vibration-temperature units
- Each mode of the load-vibration-temperature units (LVT) load reading mode, vibration mode, and temperature mode
- the nerve conduction belt (NCB) reads the nerve signals simultaneously.
- the readings from load-vibration-temperature units (LVT) as well as nerve conduction belt (NCB) is recorded and displayed through the processing unit (PU).
- This data is transferred from load- vibration-temperature units (LVT) and nerve conduction (NCB) belt through a connector to the processing unit (PU).
- the data can be transmitted through wires or wirelessly.
- the device (100) comprises a processing unit (PU) configured to receive signals from the load-vibration- temperature unit (LVT) and from the nerve conduction belt (NCB).
- PU processing unit
- LVT load-vibration- temperature unit
- NCB nerve conduction belt
- this device (100) replaces traditional touch / pressure sensation with plantar tissue stiffness, which has been established as a more reliable measure. It involves exerting a controlled force using an indenting mechanism (IM) on the foot sole and measuring the displacement of the local tissue of the foot that it is in communication with. Displacement of indenter is measured and applied force is known. Tissue stiffness is given by ratio of applied force to measured displacement.
- IM indenting mechanism
- a user’s / patient’s perception (vibration and temperature) threshold, applied by the load-vibration-temperature (LVT) unit, of applied stimuli is obtained using the nerve conduction belt (NCB).
- NNB nerve conduction belt
- the pressure pad (PP) locates high pressure points on the patients’ (10) foot (10a), where the load-vibration-temperature units (LVT) are placed.
- Processing all three signals, into the processing unit (PU), provides for a simultaneous reading of all the three parameters required to correctly determine onset of diabetic foot neuropathy in the patient, onset of ulcers in a diabetic foot, and / or classifying whether a patient is neuropathic or non- neuropathic.
- the device (100) evaluates the foot of a patient and displays results.
- Dummy units, which correspond to high pressure points are replaced with LVT units by a doctor.
- the indenting mechanism moves the pad containing the LVT Units along the guides (G) at a constant rate.
- the force exerted by the plantar tissue will be measured by the load sensor.
- the vibration actuator will generate increasing vibrations; sensors in the nerve conduction belt record action potential (electrical activity) to give vibration perception threshold (VPT) of the patient.
- VPT vibration perception threshold
- the temperature actuator (heating element) will gradually increase temperature up to a safe limit; sensors in the nerve conduction belt record action potential (electrical activity) to obtain temperature perception threshold (TPT).
- the device of this invention, combines all the screening parameters i.e. touch, vibration, and temperature into a single unit and evaluate at the same time while current devices available with clinicians evaluate these parameters discretely.
- the device, of this invention checks for the nerve response using nerve conduction belt while evaluating the parameters, therefore more accurate than existing devices which do these evaluations based on patients response.
- the device also evaluates the tissue stiffness which, in present scenario, no device is evaluating.
- the device, of this invention also helps doctors as well as patients to understand the depth of the problem by classifying them in three different zones - (e.g. Green, Orange and Red).
- zones - e.g. Green, Orange and Red.
- the TECHNICAL ADVANCEMENTS of this invention lies in providing a device which enables automatic, accurate, and rapid evaluation of diabetic foot neuropathy, overcoming the limitations of currently available products. This is achieved by consecutively applying three stimuli (pressure, vibration and temperature), automatically perceiving each sensation (by checking nerve firing), and displaying the results to enable screening (red-danger; orange-alert; green- normal). The entire process will take less than five minutes.
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- Percussion Or Vibration Massage (AREA)
Abstract
L'invention concerne un dispositif de dépistage d'un pied diabétique, ledit dispositif comprenant : une plaque mobile (DP) se déplaçant vers et à l'opposé d'une plaque supérieure fonctionnelle (TP) espacée parallèlement, ledit mouvement étant actionné par un mécanisme d'indentation (IM), ladite plaque mobile (DP), dans une première configuration, étant configurée pour héberger un réseau d'unités factices (DU) pour exercer et enregistrer une pression contre la surface de la peau d'un utilisateur (10a) afin de déterminer des points de haute pression de ladite peau (10a) afin de remplacer lesdites unités factices (DU) déterminées par des unités de température-vibration-température (LVT), dans une seconde configuration, ladite plaque mobile (DP) étant configurée pour exercer un changement de pression, de vibration et de température, à travers lesdites unités de température-vibration-température (LVT), afin d'enregistrer des signaux de potentiel d'action en conséquence du changement de chacune des pressions, vibrations et température, lesdits signaux de potentiel d'action étant enregistrés par une courroie de conduction nerveuse (NCB).
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IN201821005692 | 2018-02-15 | ||
IN201821005692 | 2018-02-15 |
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WO2019159195A1 true WO2019159195A1 (fr) | 2019-08-22 |
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PCT/IN2019/050114 WO2019159195A1 (fr) | 2018-02-15 | 2019-02-14 | Dispositif de dépistage d'un pied diabétique |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN117562510A (zh) * | 2024-01-10 | 2024-02-20 | 北京神州龙芯科技有限公司 | 一种便携式的糖尿病足筛查装置 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5381805A (en) * | 1990-01-24 | 1995-01-17 | Topical Testing, Inc. | Cutaneous testing device for determining nervous system function |
US9173568B2 (en) * | 2009-02-12 | 2015-11-03 | Ramot At Tel-Aviv University Ltd. | Method and system for detecting neuropathy |
US20160157772A1 (en) * | 2014-09-11 | 2016-06-09 | Duncan M. Grant | Neuropathic Assistive Device |
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2019
- 2019-02-14 WO PCT/IN2019/050114 patent/WO2019159195A1/fr active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5381805A (en) * | 1990-01-24 | 1995-01-17 | Topical Testing, Inc. | Cutaneous testing device for determining nervous system function |
US9173568B2 (en) * | 2009-02-12 | 2015-11-03 | Ramot At Tel-Aviv University Ltd. | Method and system for detecting neuropathy |
US20160157772A1 (en) * | 2014-09-11 | 2016-06-09 | Duncan M. Grant | Neuropathic Assistive Device |
Non-Patent Citations (1)
Title |
---|
POPALWAR, HARSHANAND J ET AL.: "Clinical Examination and Foot Pressure Analysis of Diabetic Foot: Prospective Analytical Study in Indian Diabetic Patients", NATIONAL JOURNAL OF MEDICAL RESEARCH, vol. 6, no. 1, 1 January 2016 (2016-01-01), pages 17 - 22 * |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN117562510A (zh) * | 2024-01-10 | 2024-02-20 | 北京神州龙芯科技有限公司 | 一种便携式的糖尿病足筛查装置 |
CN117562510B (zh) * | 2024-01-10 | 2024-04-09 | 北京神州龙芯科技有限公司 | 一种便携式的糖尿病足筛查装置 |
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