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Sensory Function Evaluation Device

Abstract: ABSTRACT SENSORY FUNCTION EVALUATION DEVICE The present invention relates to sensory device for measuring sensation. In the present device, different sensors are used and value can be increase or decrease through different knobs. At the same time, it will display on an LED screen and compare those with normative reference values and also use them for modification of treatment plans and prevention purposes. The device offers concurrent display of subjective and objective sensory values, facilitating the identification of normative reference values and modification of treatment plans based on acquired data. With its user-friendly design and standardized measurement protocols, this device promises to enhance the accuracy and efficacy of sensory evaluation in physiotherapy practice.

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Patent Information

Application #
Filing Date
15 December 2023
Publication Number
31/2024
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

MARWADI UNIVERSITY
MARWADI UNIVERSITY, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India
Dr. Desai Bhakti Rajeshbhai
MARWADI UNIVERSITY, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India
Dr. Kakkad Ashish Dhirajlal
MARWADI UNIVERSITY, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India

Inventors

1. Dr. Desai Bhakti Rajeshbhai
MARWADI UNIVERSITY, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India
2. Dr. Kakkad Ashish Dhirajlal
MARWADI UNIVERSITY, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India

Specification

DESC:FORM 2
THE PATENT ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. Title of the invention: “SENSORY FUNCTION EVALUATION DEVICE”
2. Applicants:
NAME NATIONALITY ADDRESS
1.MARWADI UNIVERSITY
2. Dr. Desai Bhakti Rajeshbhai
3. Dr. Kakkad Ashish Dhirajlal Indian MARWADI UNIVERSITY, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India
3. Preamble to the description
COMPLETE SPECIFICATION
The following specification particularly describes the invention and the manner in which it is to be performed:


Field of the Invention
The present invention relates to healthcare technology, specifically targeting the niche of physiotherapy. Within this field, it addresses a critical gap by introducing a ground-breaking device for objectively measuring sensory function. Sensory evaluation is paramount in physiotherapy, influencing diagnosis, prognosis, and treatment planning. This invention revolutionizes sensory assessment by integrating advanced sensors and controls to measure pressure, temperature, and vibration sensations. In the present device, different sensors are used and value can be increase or decrease through different knobs. At the same time, it will display on a Light-Emitting Diode (LED) screen and compare those with normative reference values and also use them for modification of treatment plans and prevention purposes.

Background of the Invention
Examination of sensory function contributes critical information for establishing a physical therapy diagnosis and prognosis, identifying anticipated aims and expected outcomes, and developing a Plan of Care. An important feature of the examination includes determining the pattern (specific boundaries) of sensory involvement. Periodic re-examination provides critical data on changes in the status of the patient and in determining progress toward the aims and outcomes. Individual tests for each sensory modality have been presented.
Reliability of these test procedures can be bettered by the careful adherence to consistent guidelines, administration of tests by trained professionals, and subsequent retests performed by the same examiner. Test result should be document and address the type(s) of sensation affected, the quantity, degree of involvement, and localization of the exact boundaries of the sensory deficits.
Finally, it should be highlighted that additional research related to sensory testing is justified. Further development of Quantitative Sensory Testing (QST) techniques, standardized protocols, reliability measures, and additional normative data will significantly better the clinical applications of data obtained from the examination of sensory function.
An important component of physical therapy intervention is to accurately and efficiently meet individual patient needs. Together with information from the history and review of systems, screenings assist the therapist in proficiently identifying the needed tests and measures and setting priorities within the examination process.
Screenings comprising of a series of brief tests that provide the therapist an “overview” of the system of interest (e.g., musculoskeletal, neuromuscular). There are various screening methods available as below:
1. VIBRATION
Tuning forks are made of steel or magnesium alloy and grossly resemble a two-pronged fork. When the tines are stuck against a surface (usually the palm of the examiner’s hand) the fork resonates at a specific pitch (e.g., 128, 256, or 512 Hz) determined by the length of the two U-shaped prongs (tines).
Bio-thesiometer instrument is designed to quantitatively measure threshold perception of a vibratory stimulus. The stimulus is applied using a handheld device applied to the skin. Intensity of stimulation can be preset or gradually increased until the threshold is reached (or gradually lowered until no longer felt).
Vibrameter also quantitatively measures the perception of vibration. Standardized test points have been identified for use with this instrument. The test points (e.g., dorsum of the metacarpal bone of index finger, first metatarsal, and on tibia) allow for ease of comparison and interpretation of results. The sites also represent relatively long neural pathways for transmission to the CNS (Central nervous system). Stimulus is applied using the handheld device. Handheld transducers are used to apply the stimuli. Patient responses are recorded using a handheld pushbutton device or a continuous electronic Visual Analog Scale (VAS). During examination, data are automatically stored in a computer database.
2. PRESSURE
The therapist’s fingertip or a double-tipped cotton swab is used to apply a firm pressure on the skin surface. This pressure should be firm enough to indent the skin and to stimulate the deep receptors. This test can also be administered using the thumb and fingers to squeeze the Achilles tendon. Response of patient is asked to indicate when an applied stimulus is recognized by responding “yes” or “no.”
3. TEMPERATURE
Temperature Awareness, this test determines the ability to distinguish between warm and cool stimuli. Two test tubes with stoppers are required for this examination; one should be filled with warm water and the other with crushed ice. Ideal temperatures for cold are between 41°F (5°C) and 50°F (10°C) and for warmth, between 104°F (40°C) and 113°F (45°C). Caution should be exercised to remain within these ranges, because exceeding these temperatures may elicit a pain response and consequently inaccurate test results. The side of the test tube should be placed in contact with the skin (as opposed to only the distal end). This technique provides sufficient surface area contact to determine the temperature. The test tubes are randomly placed in contact with the skin area to be tested. All skin surfaces should be tested. Response of patient is asked to reply hot or cold after each stimulus application.
Tip Therma is an early detection tool for identification of changes in thermal perception designed for monitoring Polyneuropathies associated with diabetes. It provides a method for patients to test temperature sensitivity of their feet independently. It provides only a gross estimate of temperature perception; however, its convenience, low cost, and patients’ ability to use it are important characteristics. The tool can be used many times, requires no energy, and makes use of the special characteristics of synthetic material and metal. One end is metal and the opposite side is synthetic material. Both materials are essentially at room temperature; however, the metal end takes more heat from the body (metal has a higher conductivity than the synthetic end). As a result, the metal end is perceived as warm and the synthetic end as cooler.
The Tip Therma is a thermal instrument designed for patient monitoring of gross temperature perception of the feet. The instrument is 4 inches (100 mm) long with a .59-inch (15 mm) diameter.
In this fast-growing world of health science at present, there is no formula or scale which identifies sensory changes in diabetes subjects. Era of evidence-based practice and clinical reasoning is emerging day by day. Technology is moving ahead day by day, leaving us all confined in splendor and comfort with a lot of unknown harmful side effects on health. Clinician can initiate early intervention by educating patients on the dos and don’ts for prevention and modification. To provide a proper education for subjects with Diabetes Mellitus which emphasis on daily inspection of the feet, implementation of the appropriate level of weight bearing activities, selection of proper footwear, check sensitive pressure area and improve overall expectances of life.
So, it becomes of utmost importance that there should be some objective criteria to evaluate sensory changes in diabetes subjects and its analysis by normative reference value of normal individual. Hence, the present invention is solving this problem by developing sensory device.
The present invention address to physiotherapy care device, the evaluation of sensory function stands as a cornerstone in the diagnostic and therapeutic process. Understanding the nuances of sensory perception not only aids in diagnosing underlying conditions but also guides the formulation of effective treatment plans and prognoses. Traditionally, sensory evaluation has relied on subjective assessments and rudimentary tools, leading to limitations in accuracy and reliability.
The present invention represents a significant advancement in the field of physiotherapy, with the potential to elevate standards of care, improve patient outcomes, and contribute to the ongoing evolution of rehabilitative medicine.
Objective of the Invention
The main object of the present invention is to develop a Sensory Function Evaluation Device for analysis of pressure, temperature and vibration sensation for a person with type-II diabetes mellitus and Normal Healthy Individual.
Another object of the present invention is to test & assess a Sensory Function Evaluation Device for analysis of pressure, temperature and vibration sensation for a person with type-II diabetes mellitus and Normal Healthy Individuals.
Yet another object of the present invention is to determine in a timely manner if referral to another health care practitioner is warranted.
Yet another object of the present invention is to identify system-related impairments that contribute to activity limitations or disability.
Yet another object of the present invention is to provide a comprehensive solution for the objective measurement of sensory function in physiotherapy by integrating advanced sensors and controls, the device aims to assess multiple sensory modalities, including pressure, temperature, and vibration, within a single, cohesive platform.
Yet another object of the present invention is to improve the accuracy and reliability of sensory evaluation in physiotherapy practice by standardizing measurement protocols and minimizing user variability, the invention seeks to ensure consistent and precise assessment of sensory function, thereby facilitating more accurate diagnoses of underlying conditions.
Yet another object of the present invention is to assist clinicians in formulating tailored treatment plans based on objective sensory assessment data by providing both subjective and objective values, the device empowers clinicians to make informed decisions regarding treatment modalities, intensity, and progression, ultimately optimizing patient outcomes.
Yet another object of the present invention is to enable real-time data acquisition and analysis during sensory evaluation by incorporating advanced microcontroller systems and human-computer interaction interfaces, the device allows for instantaneous feedback, facilitating timely adjustments to treatment protocols and interventions.
Yet another object of the present invention is to standardize sensory evaluation procedures and enhance the efficiency of assessment processes in physiotherapy by streamlining measurement techniques and consolidating multiple assessment tools into a single, user-friendly device, it aims to minimize time and resource expenditure while maximizing clinical utility.
Summary of the Invention:
The present invention relates to sensory device which measures subjective as well as objective value for measuring sensation. In the present device, different sensors are used and value can be increase or decrease through different knobs. At the same time, it will display on screen and compare those with normative reference values and also use them for modification of treatment plans and prevention purposes. By integrating advanced sensors, microcontroller systems, and human-computer interaction interfaces, the device offers a comprehensive solution for measuring pressure, temperature, and vibration sensations. Its multifunctional design enables clinicians to assess sensory function with unparalleled accuracy, reliability, and efficiency. Key features of the invention include standardized measurement protocols, real-time data acquisition, and both subjective and objective value generation. This empowers clinicians to make informed decisions regarding diagnosis, prognosis, and treatment planning, ultimately optimizing patient outcomes. By streamlining assessment processes and enhancing clinical utility, the device represents a significant advancement in the field of physiotherapy, with the potential to revolutionize rehabilitative medicine practice.

Brief description of drawings
Figure 1 shows front view of a sensory function evaluation device
Figure 2 shows rear view sensory function evaluation device
Figure 3 shows top view of sensory function evaluation device
Figure 4 shows bottom view sensory function evaluation device
Figure 5 shows left side view sensory function evaluation device
Figure 6 shows right side view sensory function evaluation device
Figure 7 shows perspective view of sensory function evaluation device
Notation Represents
M Microcontroller
PS Power source
TS Temperature sensor
P Potentiometer
LC Load cell
LS LED screen
S Switch
B Push button
HB Aluminium heating block
HC Heating Cartage
VM Vibration motor
W Wires
BM Bluetooth module
A Amplifier
PCB PCB board
A’ Adaptor
DCJ DC jerk
DCM DC motor
K Knobs
C Connector

Figure 8 shows block diagram of sensory function evaluation device
Figure 9 shows working methodology of sensory function evaluation device
Detailed Description of the Invention:
The following description relates to a particular manifestation of the present invention. The present invention relates to sensory device which measures subjective as well as objective value for measuring sensation. The present Sensory Function Evaluation Device comprising of a main Microcontroller (M) was Arduino Namo wifi8 bit processes and AtMega328 chi, main Power source (PS) was 12 V, 1A which is given by the adaptor (A’) and positive is connected to vin part and negative is connected with ground of nano via on/off toggle switch (S). The heating aluminium block (HB) is heated by 40 W heating cartage (HC). Temperature of cartage is cut-off by 5V relay. Temperature of heating cartage (HC) and block (HB) is sense by DS 18BC temperature sensor (TS) there are 2 vibrator motor (VM) used in one is 0 to 55Hz and second is for 60 to 300 Hz, which is operated by nano and controlled by l0 K potentiometer (P). For the pressure measurement, cantilever type load cell (LC) is used. Load cell (LC) is connected to Ha711 circuit which is connected with nano (M). For turning zero load cells, push button (B) is used. All the parameters are displayed in 20 cm*4 cm LED Screen (S).
This device mainly used to measure three sensations, that is, pressure, temperature and vibration. Main features of all the sensation measure in a single unit. This is a cost-effective handheld device mainly helps in measuring subjective as well as objective values.

Details about individual components:

1. 3D printed case
It is stationary component which is used to hold other PCB board components like load cell (LC), LCD, Potentiometer (P), Switch (S) etc.
2. 20*4 LCD Screen (LS)
It is used to show all parameters like Pressure, Skin temperature, Tissue Temperature and Vibration. LCD (LS) is connected with Arduino board (M).
3. 10K Potentiometer (P)
It is used to change or set value of temperature, vibration and change the LCD screen menu. It is connected to Microcontroller (M).
4. Toggle Switch (S)
It is used to on-off the instrument. It is connected to DC jerk.
5. Push Button (B)
It is used to targeting zero value or reset the value.
6. Aluminium Heating Block (HB)
It is sensible part which can heat up according to set temperature. It consists of temperature sensor and cartage.
7. Temperature Sensor (TS)
It is shows temperature value of aluminium heating block (HB) on the LCD screen (LS). It is connected to Microcontroller (M).
8. 40W Heating Cartage (HC)
It is used to heating aluminium block (HB) and cut off with relay.
9. 60 to 300 Hz Vibration Motor (VM)
Connected with DC motor.
10. 0 to 60 Hz Vibration Motor (VM)
Connected with DC motor.
11. IR temperature sensor (TS)
It is used to measure skin temperature.
12. Insulated Copper wires (W)
Used for connection.
13. Hc-05 Bluetooth module (BM)
It is used to transmit parameters vie Bluetooth and shows parameters value in mobile app. It is connected to microcontroller (M).
14. 40 kg load cell (LC)
It is used to measure pressure and connected with it.
15. H*711 Amplifier (A)
It is placed between load cell (LC) and microcontroller (M) which convert analogue single of load cell (LC) to digital single.
16. 5V cut- off relay
It is placed between 40 W heating cartage (HC) and Microcontroller (M) which cut off power according to set temperature value.
17. Arduino nano (M)
It is the heart of instrument. All Programme is done by it.
18. PCB board (PCB)
It consists all wired component to microcontroller (M).
19. 12 V 1 A adaptor (A’)
It given power the whole instrument components.
20. DC jerk (DCJ)
It is placed between adaptor (A’) and microcontroller (M).
Adaptor male pin is connected with DC jeck (DCJ) female pin.
21. DC motor (DCM)
It maintains and change the speed of vibratory motor (VM).
The components of the present invention with material list as shown in below table 1:
Table 1: Used components with material
Sr. No. Components Material
1 3D printed Box Polycarbonate plastic
2 20*4 LED Screen Plastic glass
3 Green PCB laminated composite made from non-conductive substrate materials with layers of copper circuitry buried internally or on the external surfaces
4 12 V 1 A adapter Plastic
5 12 v DC jack Plastic steel
6 Cut off relay PCB
7 Heating aluminum square block Aluminum Alloy
8 Heating cartage Steel
9 Heating aluminum square block temperature sensor Steel
10 Infrared temperature sensor PCB
11 Arduino nano original PCB
12 40 kg load cell Aluminum Alloy
13 Load cell mounting Aluminum Alloy
14 Hx711 load cell amplifier PCB
15 Push button circuit PCB
16 Switch Steel
17 Potentiometer with Nobe Plastic
18 Mini vibration motor Steel
19 Vibration motor Steel
20 Screw Temper steel
21 Wire Insulated copper
22 Bluetooth PCB
Main embodiment of the present invention, a Sensory Function Evaluation Device comprising of:
a) Microcontroller (M);
b) 12 V, 1A Power source (PS) given by the adaptor (A’), positive is connected to vin part and negative is connected with ground of microcontroller (M) via on/off toggle switch (S);
c) Heating aluminium block (HB) is heated by 40 W heating cartage (HC) which consists of temperature sensor (TS) and heating cartage (HC);
d) Temperature of cartage (HC) is cut-off by 5V relay;
e) Temperature of heating cartage (HC) and block (HB) is sense by 18BC temperature sensor (TS);
f) Vibrator motor (VM) operated by microcontroller (M) and controlled by l0 K potentiometer (P);
g) Cantilever type load cell (LC) is used for the pressure measurement;
h) Push button (B) is used for turning zero load cells (LC);
i) All sensations are displayed in LED Screen (S) which connected to microcontroller (M);
j) Bluetooth module (BM);
k) Amplifier (A) placed between load cell (LC) and microcontroller (M) to convert analogue single of load cell (LC) to digital single;
l) PCB board (PCB);
m) DC jerk (DCJ) placed between adaptor (A’) and microcontroller (M); and
n) DC motor (DCM) maintains and change the speed of vibratory motor (VM);
Wherein said device controls to measure pressure, temperature, and vibration sensations in subjective and objective value.
Another embodiment of the present invention is said microcontroller (M) is an Arduino Nano WiFi 8-bit processor incorporating an AtMega328 chip.
Another embodiment of the present invention is said device measures sensations for person with type-II diabetes mellitus and Normal Healthy Individual.
Another embodiment of the present invention is said two vibrator motor (VM) used one is for 0 to 55Hz and second is for 60 to 300 Hz.
Another embodiment of the present invention is said Load cell (LC) is connected to Ha711 circuit which is connected with microcontroller (M).
Another embodiment of the present invention is said device measures the parameters such as Pressure, Skin temperature, Tissue Temperature and Vibration are displayed in 20 cm*4 cm LED Screen (S).
Working methodology of the present invention:
? With the collaboration of Bio-engineering department Prototype instrument was developed.
? Sensorial Functional Device as outlined in the following specifications, a main Microcontroller (M) is Arduino Namo Wi-Fi 8-bit processes and AtMega328. Main Power source (PS) is 12 V, 1A which is given by the adaptor (A’) and positive is connected to vin part and negative is connected with ground of nano via on/off toggle switch (S). The heating aluminum block (HB) is heated by 40 W heating cartage (HC).
? Temperature of cartage is cut-off by 5V relay. Temperature of heating cartage (HC) and block (HB) is sense by DS 18BC temperature sensor. There are 2 vibrator motors (VM) used in one is 0 to 55Hz and second is for 60 to 300 Hz, which is operated potentiometer (P). For the pressure measurement, cantilever type load cell (LC) is used.
? After development of Prototype device, through purposive sampling subjects was selected according to inclusion and exclusion criteria.
? After that assess the different points with the help of Sensory evaluation functional device and compare with the normative value. In that checking three 3 different sensations: Pressure, Temperature and Vibration. With the help of different knobs either increasing or decreases the value, once subject felt that value use for data interpretation.
Evaluation of the present invention:
In present invention, the sample size was calculated by considering prevalence rate more than 62 million people with 95% at 1% standard error which gave sample size around 3000 for type-II diabetes mellitus and normal healthy individual.
Sampling is related with selecting a few individuals from a targeted population for estimation of characteristics of an entire population. In the present research, a purposive sampling used for person with type- II diabetes mellitus.
Inclusion criteria as well as exclusion criteria are set of already defined characteristics for identifying participants as target population for a research purpose. Inclusion & exclusion criteria are as per requirement of the scientific objectives of the research and proper selection of participants may increase the validity of the research and improve feasibility. Appropriate selection criteria provide homogeneity of the selected sample and reduce effect of confounding factors in the study.
Inclusion Criteria:
Age between 30-60 years.
Person with normal cognitive function. (MMSE >23)
Duration of diabetes (2-10 years), on using oral hypoglycemic agents or those who are in injection of insulin.
Gender Both male and female.
Exclusion Criteria:
Person having any neurological disorders, history of any musculoskeletal injury in the last 6 months.
Person having open ulcer, any type of foot injury or infection.
Neurological disorder persons, chronic alcoholism, renal failure, type I diabetic patients are excluded.
No previous history of any systemic condition related to peripheral neuropathy
Person with any Musculoskeletal Disorder like any fracture of lower limb, Lumbar Radiculopathy etc
Tools used in the present sensory device are as follows:
1. 128 Hz Tuning Fork,
2. Cotton,
3. Hammer,
4. 10g SemmeinWeiesten Monofilament,
5. Digital Weighing Machine,
6. Stadiometer
7. Self-developed device for “Sensory Function Evaluation Device”
8. Data collection form
9. Consent form
10. Pen, Paper
11. In Low’s 60- second diabetic screening tool
12. Michigan Neuropathy Screening tool

Procedure of study:
1. Michigan Neuropathy Screening Instrument (MNSI)
For all assessments, the foot should be warm (>30°C).
Foot Inspection: The feet are inspected for evidence of excessively dry skin, callous formation, fissures, frank ulceration or deformities. Deformities include flat feet, hammer toes, overlapping toes, halux valgus, joint sublaxation, prominent metatarsal heads, medial convexity (Charcot foot) and amputation.
Vibration Sensation: Vibration sensation should be performed with the great toe unsupported. Vibration sensation will be tested bilaterally using a 128 Hz tuning fork placed over the dorsum of the great toe on the boney prominence of the DIP joint. Patients, whose eyes are closed, will be asked to indicate when they can no longer sense the vibration from the vibrating tuning fork. In general, the examiner should be able to feel vibration from the hand-held tuning fork for 5 seconds longer on his distal forefinger than a normal subject can at the great toe (e.g. examiner’s DIP joint of the first finger versus patient’s toe). If the examiner feels vibration for 10 or more seconds on his or her finger, then vibration is considered decreased.
A trial should be given when the tuning fork is not vibrating to be certain that the patient is responding to vibration and not pressure or some other clue.
Vibration is scored as:
1) Present if the examiner senses the vibration on his or her finger for < 10 seconds,
2) Reduced if sensed for = 10 or 3) absent (no vibration detection.) Muscle Stretch Reflexes: The ankle reflexes will be examined using an appropriate reflex hammer (e.g. Trimmers or Queen square).
The ankle reflexes should be elicited in the sitting position with the foot dependent and the patient relaxed. For the reflex, the foot should be passively positioned and the foot dorsiflexed slightly to obtain optimal stretch of the muscle. The Achilles tendon should be percussed directly. If the reflex is obtained, it is graded as present. If the reflex is absent, the patient is asked to perform the Jendrassic maneuver (i.e., hooking the fingers together and pulling). Reflexes elicited with the Jendrassic maneuver alone are designated “present with reinforcement.” If the reflex is absent, even in the face of the Jendrassic maneuver, the reflex is considered absent.
Monofilament Testing: For this examination, it is important that the patient’s foot be supported (i.e., allow the sole of the foot to rest on a flat, warm surface). The filament should initially be pre stressed (4-6 perpendicular applications to the dorsum of the examiner’s first finger). The filament is then applied to the dorsum of the great toe midway between the nail fold and the Distal Interphalageal joint. Do not hold the toe directly. The filament is applied perpendicularly and briefly, (<1 second) with an even pressure.
When the filament bends, the force of 10 grams has been applied. The patient, whose eyes are closed, is asked to respond yes if he/she feels the filament. Eight correct responses out of 10 applications are considered normal: one to seven correct responses indicate reduced sensation and no correct answers translates into absent sensation.
The MNSI questionnaire is self-administered. Responses are added to obtain a total score. ’Yes ‘responses to questions 1–3, 5–6, 8–9, 11–12, 14–15 is each counted as one point. ’No ‘responses to questions 7 and 13 each count as one point. Question 4 was considered to be a measure of impaired circulation and question 10 a measure of general asthenia and were not included in the published scoring algorithm. A score of = 7 was considered abnormal. All 15 questions were included in the new scoring algorithms. During the MNSI examination, a health professional inspects each foot for deformities, dry skin, calluses, infections and fissures. Each foot with any abnormality receives a score of 1.
Each foot is also inspected for ulcers and each foot with an ulcer receives a score of 1. The ankle reflexes are also elicited. If the reflex is absent, the patient is asked to perform the Jendrassic maneuver and, if present, the reflex is designated as present with reinforcement and is scored as 0.5. If the reflex is absent with the Jendrassic maneuver, the reflex is designated as absent and is scored as 1. Vibration sensation is then tested in the great toe using a 128-Hz tuning fork. In general, the examiner should be able to feel vibration in his or her hand for 5 s longer than a normal subject can at the great toe. Vibration is scored as present if the examiner senses the vibration on his or her finger for < 10 s longer than the subject feels it in the great toe, decreased if sensed for = 10 s (scored as 0.5) or absent (scored as. The total possible score is 8 points and, in the published scoring algorithm, a score = 2.5 is considered abnormal.
2. Inlow’s 60- second Diabetic Foot Screen tool
This tool is designed to assist in screening persons with diabetes to prevent or treat diabetes-related foot ulcers and/or limb threatening complications. The screen should be completed on admission of any person with diabetes and then repeated as directed by risk and clinical judgment. Patient may require frequent and regular visits for routine care but complete the screening as indicated or as relevant based on clinical judgment.
Specific Instructions:
Step 1: Explain screening to the patient and have them remove their shoes, socks from both feet.
Step 2: Remove any dressings or devices that impair the screening.
Step 3: Review each of the parameters for each foot as listed in the Inlow’s 60-second Diabetic Foot Screen and select the appropriate score based on patient’s status. (An amputation may affect the score on the affected limb.)
Step 4: Once the screen is completed determine care recommendations based on patient need, available resources and clinical judgment.
Step 5: Use the highest score from either the left or right foot to determine recommended screening intervals.
Step 6: Set up an appointment for the next screening based on screening score and clinical judgment
3. Sensorial Functional Device for measuring 3 Sensation i.e. Pressure, Temperature and Vibration
In the field of physiotherapy, there is no instrument that measure objective value for measuring sensation. This instrument measures both the value subjective as well as objective. For that different sensors are used and different knobs through those values either increasing or decreasing. At the same time, it will display on screen. The present invention identifies normative reference value and also used for modification of treatment plan and prevention purpose.
The Sensory Function Evaluation Device has a main Microcontroller is Arduino Namo wifi8 bit processes and AtMega328 chi. Main Power source is 12 V, 1A which is given by the adaptor and positive is connected to vin part and negative is connected with ground of nano via on/off toggle switch. The heating aluminium block is heated by40 W heating cartage.
Temperature of cartage is cut-off by 5V relay. Temperature of heating cartage and block is sense by DS 18BC temperature sensor There are 2 vibrator motor used in one is 0 to 55Hz and second is for 60 to 300 Hz, which is operated by nano and controlled by l0 K potentiometer. For the pressure measurement, cantilever type load cell is used. Load cell is connected to Ha711 circuit which is connected with nano. For turning zero load cell, push button is used. All the parameters are displayed in 20 cm*4 cm display.
Appropriate statistical analysis of the data using adequate statistical techniques is essential for any research. Statistical analysis helps to mention the data meaningfully and to present the complex data in a very simple manner. ,CLAIMS:We claim,
1. A Sensory Function Evaluation Device comprising of:
a) Microcontroller (M);
b) 12 V, 1A Power source (PS) given by the adaptor (A’), positive is connected to vin part and negative is connected with ground of microcontroller (M) via on/off toggle switch (S);
c) Heating aluminium block (HB) is heated by 40 W heating cartage (HC) which consists of temperature sensor (TS) and heating cartage (HC);
d) Temperature of cartage (HC) is cut-off by 5V relay;
e) Temperature of heating cartage (HC) and block (HB) is sense by 18BC temperature sensor (TS);
f) Vibrator motor (VM) operated by microcontroller (M) and controlled by l0 K potentiometer (P);
g) Cantilever type load cell (LC) is used for the pressure measurement;
h) Push button (B) is used for turning zero load cells (LC);
i) All sensations are displayed in LED Screen (S) which connected to microcontroller (M);
j) Bluetooth module (BM);
k) Amplifier (A) placed between load cell (LC) and microcontroller (M) to convert analogue single of load cell (LC) to digital single;
l) PCB board (PCB);
m) DC jerk (DCJ) placed between adaptor (A’) and microcontroller (M); and
n) DC motor (DCM) maintains and change the speed of vibratory motor (VM);
Wherein said device controls to measure pressure, temperature, and vibration sensations in subjective and objective value.
2. The sensory function evaluation device as claimed in claim 1, wherein said microcontroller (M) is an Arduino Nano WiFi 8-bit processor incorporating an AtMega328 chip.
3. The sensory function evaluation device as claimed in claim 1, wherein said device measures sensations for person with type-II diabetes mellitus and Normal Healthy Individual.
4. The sensory function evaluation device as claimed in claim 1, wherein said two vibrator motor (VM) used one is for 0 to 55Hz and second is for 60 to 300 Hz.
4. The sensory function evaluation device as claimed in claim 1, wherein said Load cell (LC) is connected to Ha711 circuit which is connected with microcontroller (M).
5. The sensory function evaluation device as claimed in claim 1, wherein said device measures the parameters such as Pressure, Skin temperature, Tissue Temperature and Vibration are displayed in 20 cm*4 cm LED Screen (S).
Dated 12th June, 2024

Chothani Pritibahen Bipinbhai
Reg. No.: IN/PA-3148
For and on behalf of the applicant

Documents

Application Documents

# Name Date
1 202321085629-PROVISIONAL SPECIFICATION [15-12-2023(online)].pdf 2023-12-15
2 202321085629-FORM 1 [15-12-2023(online)].pdf 2023-12-15
3 202321085629-DRAWINGS [15-12-2023(online)].pdf 2023-12-15
4 202321085629-DRAWING [12-06-2024(online)].pdf 2024-06-12
5 202321085629-COMPLETE SPECIFICATION [12-06-2024(online)].pdf 2024-06-12
6 202321085629-FORM-9 [11-07-2024(online)].pdf 2024-07-11
7 202321085629-FORM-5 [11-07-2024(online)].pdf 2024-07-11
8 202321085629-FORM-26 [11-07-2024(online)].pdf 2024-07-11
9 202321085629-FORM 3 [11-07-2024(online)].pdf 2024-07-11
10 202321085629-FORM 18 [11-07-2024(online)].pdf 2024-07-11
11 202321085629-RELEVANT DOCUMENTS [11-06-2025(online)].pdf 2025-06-11
12 202321085629-POA [11-06-2025(online)].pdf 2025-06-11
13 202321085629-FORM 13 [11-06-2025(online)].pdf 2025-06-11
14 202321085629-EVIDENCE FOR REGISTRATION UNDER SSI [23-09-2025(online)].pdf 2025-09-23
15 202321085629-EDUCATIONAL INSTITUTION(S) [23-09-2025(online)].pdf 2025-09-23