WO2017046735A1

WO2017046735A1 - Apparatus for the evaluation of the discrimination and heat sensitivity in diabetes patients

Info

Publication number: WO2017046735A1
Application number: PCT/IB2016/055501
Authority: WO
Inventors: Giacomo Vespasiani
Original assignee: Meteda S.R.L.
Priority date: 2015-09-16
Filing date: 2016-09-15
Publication date: 2017-03-23

Abstract

The apparatus for the evaluation of the discrimination and heat sensitivity in diabetes patients includes a casing (1), an end (2) of which is used as a handle while the other operating end (3) carries a laser type thermometer (5). Two probes (6, 7) are situated respectively on the lateral opposite surfaces of the operating end (3), the probes being heated by low power Peltier cells having limited dimensions, with temperatures respectively equal to the one taken by the thermometer (5), and the one set by the user of the apparatus by means of a circuitry and electronic control devices, powered by a battery of limited dimensions and situated inside and on the surface of the casing (1) to control the apparatus.

Description

APPARATUS FOR THE EVALUATION OF THE DISCRIMINATION AND HEAT SENSITIVITY IN DIABETES PATIENTS

TECHNICAL FIELD

This invention relates to diagnostic tests, in particular in the field of the so-called preventive medicine, for persons suffering from sensitive neuropathies, like for example those caused by the diabetes, or for the evaluation of the clinical development of a peripheral ischemia.

In particular, the present invention relates to an apparatus for the evaluation of the discrimination and heat sensitivity in diabetes patients, that includes a test by the patient about the temperature difference between two surfaces. BACKGROUND ART

As it is known, there are tests aimed at evaluating the thermal discrimination threshold by persons, and which constitute a method for examining the alterations of the peripheral nervous system, alterations that can arise due to the diabetes mellitus.

At present, these tests are the most widespread method for studying the alterations of the peripheral nervous system, which can arise when suffering from the diabetes mellitus, and are based on the capacity or lack of capacity to perceive the variation from hot to cold and vice versa, by small peripheral nerve fibres of the patient.

A device is known for carrying out two kinds of this test in an easy way, a first kind of which relates to the Thermal Discrimination threshold, and is aimed at determining the sensitivity with respect to the smallest difference of temperature the patient is able to perceive, whereas the second one verifies the Heat Sensitivity in absolute terms and evaluates the absolute heat perception threshold.

This known device is composed first of all of a bench top console, having a liquid crystal display (LCD) installed on its front panel, while a main switch and a socket for batteries recharge are on the back.

Two external devices are connected to the console by means of connectors. The first external device is a "pen" having a probe in its terminal part, the probe taking the skin temperature of the patient, and the second external device is a kind of little hammer, with two faces electronically thermostated at different temperatures, so as to carry out the test.

The "pen" probe for the temperature and the heated hammer are integral parts of the apparatus, although they are detachable, yet they are essential components for the operation of the instrument.

The liquid crystal display shows the value of the temperature measured and generated respectively by these two components.

The "pen" is connected to the console by means of a cable, and is composed of isolating material (epoxy resin). A temperature sensor, situated at the end of the "pen", is aimed at taking the temperature of the patient's skin by direct contact.

Once measured, the temperature will be reported on one of the two faces of the hammer, which is likewise connected to the console by means of a cable and consists of a handle made of isolating material (epoxy resin) and two cylindrical lateral extensions, whose faces are made of copper treated in gold-plating acid bath.

5.3 W Peltier cells are housed respectively inside the faces and are controlled by a thermostat to heat the faces.

The electronic control of the thermostat allows keeping the two faces of the hammer independently at a temperature comprised between 18°C and 48°C.

In order to correctly carry out the Tests, the patient is sitting or lying on a bed in a comfortable position, with his/her legs bent and feet rested. The purpose of the preparation is to avoid scrupulously any annoyance factor.

Once turned on, the instrument will directly control its own functionalities and those of the associated components. After this operation has been completed, various functions will be accessible by means of a push button panel.

Then the temperatures taken by the components are acquired and shown on the display.

By using the buttons on the front panel of the instrument, for example, the thermal discrimination test can be selected, which verifies the smallest difference of temperature perceived by the patient.

Still by means of the buttons on the front panel, it is possible to select taking the patient's skin temperature by the pen with thermal probe.

The best point for taking temperature to carry out the test is the inner malleolus of lower limbs.

Once the patient's reference temperature has been acquired, the physician sets the temperature differential by the buttons of the front panel and, after a suitable predisposition time, one of the faces of the hammer will have the temperature taken by the probe of the pen, while the other face of the hammer will have the temperature corresponding to that of the probe increased by the differential value being set.

The physician will alternately place the two faces of the hammer on the patient's skin, so that the patient is not aware of which face is actually placed on his/her skin, repeating this operation more times, positioning the two faces of the hammer above and below the inner and outer malleolus, varying the differential value.

When the patient is able to indicate the face with the temperature different from his/her skin temperature by a prefixed value, for example over a minimum of 3°C, it will be possible to determine the thermal discrimination threshold of the patient being examined.

Likewise, it is possible to select the heat sensitivity test by acting on the corresponding button on the front panel.

The temperature intended to be applied to the patient's skin during the test can also be selected using a button on the front panel.

Beginning from a stimulus only a few degrees higher than the temperature taken by the probe, the temperature generated on the warmer face of the hammer is increased. Then it is further increased if the patient does not perceive it and reduced if he/she does perceive it.

The heat sensitivity threshold is calculated on the basis of the average of three subsequent perceptions.

The patient must not read the temperature values shown on the display in order to make the test reliable.

The operation of the present device is reliable, precise and useful in the correct diagnosis of sensitive neuropathies and for the evaluation of the clinical evolution of the peripheral ischemia. TECHNICAL PROBLEM

However, the constructive configuration of the instrument makes it not easy to handle, heavy, cumbersome and little or not at all suitable to be transported, also considering the number of its components.

Moreover, its energy consumption is considerable, and it leads to the need for large spaces for the supply devices (batteries) and makes the instrument significantly heavy.

OBJECTS OF THE INVENTION

The object of the present invention is to propose a constructive configuration of the instrument that allows the number of its components, energy consumption and consequently its dimensions and weight to be reduced.

The above mentioned object is obtained due to an apparatus for the evaluation of the discrimination and heat sensitivity of diabetes patients, which includes an elongated casing, one end of which is used as a handle, while the other, operating end has a laser type thermometer on its head, and on the lateral opposite surfaces respectively two probes heated, to temperatures respectively equal to the one taken by the thermometer and the one set by the user of the apparatus, by means of a circuitry and electronic control devices situated inside and on the surface of the casing, to control the apparatus.

SUMMARY OF THE INVENTION These and other objects that will become evident from the following description are all obtained by an apparatus for the evaluation of the discrimination and heat sensitivity in diabetes patients which includes a casing, whose one end is used as a handle, while the other operating end carries a laser type thermometer. On the lateral opposite surfaces of the operating end there are two probes heated, by low power Peltier cells having reduced dimensions, to temperatures respectively equal to the one taken by the thermometer and the one set by the user of the apparatus by means of a circuitry and electronic control devices, powered by a battery of reduced dimensions and situated inside and on the surface of the casing 1 to control the apparatus.

BRIEF DESCRIPTION OF THE DRA WINGS

The characteristics of the invention, not apparent from what has been said above, will become evident from the following description, to be taken with reference to the enclosed drawing, in which the only figure illustrates the device proposed by the invention in its new configuration aimed at improving handling thereof. DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

With reference to said figure, an apparatus is illustrated for the evaluation of the discrimination and heat sensitivity in diabetes patients, which includes a casing 1 .

A portion 2 of the casing 1 , the lower one in the figure, is used as a handle, while the other portion 3, the upper one in the figure, is the operative one, that is the one that acts functionally by performing the test. For this purpose, the casing 1 preferably presents an elongated conformation, like a stick.

The head 4 of the operating end 3 is provided with a thermometer 5, for example of the laser type, illustrated by way of example in an angle of the head.

Obviously, other positions can be chosen, more suitable also depending on the possible variations of the conformation of the head and the layout of various components contained therein.

Two probes 6, 7 are applied to two corresponding lateral opposite surfaces of the casing 1 . In order to make the test performing more comfortable, the probes 6 and 7 are surrounded by rings 8, 9 of soft spongy material, slightly protruding outwards.

In known ways, the heated probes house corresponding Peltier cells. In this case, however, the selected cells are low power and have reduced dimensions.

One of the probes is heated to a temperature equal to the one taken by the thermometer 5, while the other probe is heated to a temperature set by the user of the instrument, who regulates the difference in centigrade degrees between the latter temperature and the first one.

The temperature can be set by means of a circuitry, situated inside the casing 1 , and electronic control devices 10 situated on a face of the casing 1 (illustrated in the figure by way of pure example) to control the apparatus, for example to turn it on and off.

The whole is powered by a battery of small dimensions.

Operation of the device substantially does not differ from the known one.

After having activated the instrument with the turn on button, the operator takes the skin temperature by the laser thermometer situated in the operating head of the casing 1 .

After being taken, the temperature is "transferred" to one of the probes, which is marked with a coloured sign and heated to the taken temperature. Consequently, the operator sets the temperature differential, for example of 3°C, and the other probe, likewise marked with a sign of a different color, is heated to the temperature taken by the thermometer, to which the differential is added.

At this point, the test continues in the same way as the one carried out with the traditional device. The operator reduces or increases the temperature differential depending on the patient's perception or lack of perception of heat.

When the test is completed, the operator can turn the instrument off. The extreme simplicity of the use of the apparatus made according to the invention results evident.

The rationalized layout of the components in a single casing and the optimization of consumption, also due to the use of the low power Peltier cells having reduced dimensions, allow a reduction of the total dimensions and the powers dissipated by the components. A first bulky component, the "hammer", connected with a bothersome cable causing dissipation of energy, is eliminated.

Another advantage derives from the use of a laser thermometer situated in the head 4 of the operating end 3 of the apparatus. Another bulky component is also eliminated, the bulky "pen", likewise connected by a cable and causing a considerable energy consumption due to the thermal probe used and the dissipations. Consequently, it is possible to use batteries of smaller dimensions and weight.

Moreover, reassembling the instrument after each use, collecting the cables, and setting them in a way suitable to keep all the components in an orderly way, for example in a case, are no longer necessary.

The use of the instrument is very easy. It can be transported with extreme ease, since it is not a "bench top" instrument.

Also the energy autonomy is increased, because of the smaller need of energy.

It is understood that what above has been described as a pure not limiting example. Therefore, possible changes and variants of the invention are considered within the protective scope granted to the present technical solution, as described above and claimed below.

Claims

1 . An apparatus for the evaluation of the discrimination and heat sensitivity in diabetes patients, characterized in that it includes a casing (1 ), one portion (2) of which is used as a handle while the other operative portion (3) has a thermometer (5) on its head (4), and two probes (6, 7) situated respectively on the lateral opposite surfaces, heated to temperatures respectively equal to the one taken by said thermometer (5), and the one set by the user of the apparatus by means of a circuitry and electronic control devices situated inside and on the surface of said casing (1 ), to control the apparatus.

2. An apparatus according to claim 1 , wherein said heated probes house corresponding low power Peltier cells having reduced dimensions.

3. An apparatus according to one of the previous claims, wherein a battery of small dimensions is provided as a power supply.

4. An apparatus according to one of the previous claims, wherein said casing (1 ) has an elongated conformation, like a stick.

5. An apparatus according to one of the previous claims, wherein said probes (6 and 7) are surrounded by rings (8, 9) of soft spongy material.

6. An apparatus according to one of the previous claims, wherein said thermometer (5) is of a laser type.