ITPD20070404A1 - PNEUMATIC INTEGRATED ELECTRONIC DEVICE FOR MEASURING INTERFACE PRESSURE EXERCISED BY COMPRESSION BANDAGES - Google Patents

Description

TITLE

INTEGRATED OPERATING ELECTRONIC DEVICE

PNEUMATIC FOR MEASURING THE PRESSURE OF

INTERFACE EXERCISED BY COMPRESSION BANDAGES

DESCRIPTION

The present patent relates to devices for measuring the interface pressure exerted by compression bandages on human anatomical parts and in particular it concerns a new integrated pneumatically operated electronic device for measuring the interface pressure exerted by compression bandages.

Compression bandages commonly used in the therapeutic and / or preventive treatment of phlebological and lymphological pathologies of the human limbs are known.

In particular, various types of bandages are known, which can be classified according to their elasticity with a uniform, defined and controlled pressure on the limb. For example, dynamic and functional bandages are known, used particularly for partial timmobilization of the joints and widely used in sports, for athletes who have suffered trauma or are in the process of recovery.

Therapeutic elastic stockings are also known, so-called CET or MCS, from the English "Medical Compression Stocking", which exert a defined and degressive pressure on the limb.

These therapeutic elastic stockings, by exerting the right pressure on the limb, are used in order to reduce the cross section of the veins, increase the speed of venous reflux and improve the functionality of the venous valves.

It is important that the pressure exerted by the bandages remains constantly above the limit levels that guarantee the effectiveness of the compression treatment. When this pressure falls below these values, it is therefore necessary to redo the bandage.

However, bandages and the use of stockings must be applied and prescribed to patients after carefully assessing the presence and extent of other pathologies.

It is in fact known that, in the event that a patient suffers from further correlated pathologies, for example of the cardiovascular or vascular system, it is necessary to precisely quantify the peripheral arterial perfusion at rest and during exercise, i.e. it is necessary to check that the values of pressure exerted by the bandage are limited to ensure a compression class adequate to the treatment required by the particular pathologies of the patient.

Various types of devices are known for the so-called "in vivo" or "in situ" measurement of the interface pressure exerted by the compression bandages applied to the subject. For example, pneumatic, pneumatic-electric, piezoelectric, strain gauge or resistive devices are known.

The pneumatic devices, in particular, comprise at least one pneumatic sensor connected to a pressure gauge or manometer.

Said pneumatic sensor substantially consists of a cushion or hose made of thin, inextensible and highly flexible plastic film.

Said sensor is connected tightly to a duct or thin flexible tube, in turn connected, by means of a three-way tap or T-valve, to both said pressure gauge and to a syringe for injecting air into the sensor. same.

The use of this type of interface pressure measurement device requires the sensor to be correctly placed between the skin and the compression bandage applied to the limb.

When the sensor and the bandage are correctly positioned, said duct or pipe connecting the sensor is connected only to said manometer, by means of said three-way tap. The operator must now calibrate or zero the pressure gauge.

To perform this operation of zeroing the pressure gauge, the operator must fill a syringe with air, extracting the plunger completely, and then connect said syringe to said three-way tap.

The operator must then act on the pressure gauge to calibrate or reset the starting value, which must be equal to 0 mmHg.

At this point the operator must inject the air content of the syringe into the tube until the syringe is completely empty, in order to overpressure the inside of the sensor, and then immediately close the tap to disconnect the syringe. , leaving the pressure gauge connected instead.

In this way, the pressure gauge detects the pressure exerted by the bandage on the sensor and therefore on the patient's limb.

To repeat the measurement, while leaving the sensor in place, it is necessary to disconnect the syringe to be able to fill it again with air, then reconnect it to said tap, which must then be reopened, reset the pressure gauge, re-inject the air contained in the syringe, close the tap and take the new interface pressure measurement.

The operation of this type of device therefore appears rather laborious, especially due to the presence of said three-way tap, which must be opened / closed at each reset of the pressure gauge and measurement.

In particular, the closing of the tap after the injection of air inside the sensor must be performed immediately by manually holding 10 plunger in position, to prevent said plunger from being pushed towards the outside of the cylinder due to the pressure exerted by the bandage on the sensor, resulting in measurement errors.

The measurement therefore has to be repeated several times to obtain safer values, thus requiring longer operating times.

Furthermore, the operation linked to the presence of said three-way tap requires that the operator already has good dexterity, that is, a fair amount of experience.

Another drawback of known devices consists in the fact that the reset operation of the instrument must be activated by the operator, after connecting the syringe full of air to said three-way tap.

The operator must therefore first connect the syringe to the tap, then open the tap and then act on the pressure gauge until zeroing is completed.

Measuring devices that can be connected to the PC are known, ie comprising at least one interface port to the PC and an electronic circuit suitable for transmitting data in real time to the PC, where they can be stored or otherwise processed.

In the absence of the PC or the connection cables, it is not possible to transfer the data in any way, which must therefore be transcribed as they are detected, and, only at a later time, processed or stored on a PC.

To overcome all the aforementioned drawbacks, a new type of pneumatically operated electronic device has been studied and implemented for measuring the interface pressure exerted by compression bandages, with a syringe or air injector integrated into the body of the device.

The main task of the present invention is to integrate in a single compact device both the pressure measuring instrument, or pressure gauge, and said syringe or air injector, without having parts that must be assembled / disassembled during its use.

Another important object of the present invention is to simplify the use of the new device, reducing the number of operations that must physically be carried out by the operator, thanks to the fact that the air injection syringe is integrated into the body of the device and which does not necessarily have to be be connected / disconnected to the sensor and pressure gauge at each measurement.

Another important object of the present invention is to allow the measurement of the interface pressure exerted by a bandage both in rest conditions and in working conditions, ie in movement, since the sensor can be left continuously in situ.

Another important object of the present invention is that the process of zeroing the pressure gauge takes place automatically when the plunger of the syringe is in the maximum extraction position, without requiring the operator to directly and materially act on this zeroing.

Another important purpose of the present invention is to limit systematic measurement errors due to the operator, since the particular and innovative measures guarantee ease of use and repeatability of the results. Another important purpose of the present invention is to limit measurement errors due to the increase in thickness and the change in the shape of the sensor following the injection of air.

In fact, the sensor has a minimum thickness, is made of highly flexible material and furthermore, once the air is injected, the thickness increases to a limited extent, without changing the pressure measurement based on Laplace's law.

The sensor is also sized in such a way as to guarantee, within the sensor itself, a predetermined volume of injected air to ensure maximum adaptability of the sensor to the profile of the limb on which it is applied and to develop a known back pressure, in order to obtain the highest possible accuracy in sensing the interface pressure.

Another important advantage of the present invention is that it can be left in contact with the patient's skin for a long time, since it is made of hypoallergenic material which does not cause irritation.

Another important advantage of the present invention is to ensure a high duration of operation thanks to the preferable use of accumulators instead of normal batteries.

Another important object of the present invention is to allow the transmission of the data and measurements collected to a PC or other electronic device, both in real time, i.e. as the measurements are taken, and at a later time, since the data can be stored. in a memory unit of the device itself.

The connection to the PC also allows you to perform many other operations, such as displaying the pressure trend during complete dynamic tests, patient data, memorization calculations, reporting and memorization without constraints on the duration of the test being performed.

These and other direct and complementary purposes are achieved by the new pneumatically operated electronic device for measuring the interface pressure exerted by compression bandages, with syringe or air injector integrated into the body of the device.

The new electronic device comprises, in its main parts, at least one sensor of the pneumatic type, which can be connected by means of a tube to at least one measuring unit which in turn comprises at least one containment body in which at least one manometer and at least one syringe are integrated, both connected to said sensor by means of said tube, and where at least one electronic circuit receives data from said pressure gauge and allows its display, storage and possible transfer to other electronic devices, such as a PC.

Said sensor, comprising a pillow or hose hermetically connected to said tube, is adapted to be preferably placed in contact with the skin and in any case interposed between the skin and the compression bandage applied to the patient's limb.

Said sensor is connected both to said manometer and to said syringe, through said tube which comprises at least one bifurcation, where one branch is connected directly to said manometer and the second branch is directly connected to the cylinder of said syringe.

Said syringe therefore comprises a cylinder integral with said containment body, inside which cylinder slides a plunger with a sealing plate to the walls of the cylinder and with a stem at least partially protruding from said containment body, on which the stem acts the operator to inject / extract air from inside the sensor.

Said device further comprises at least one sensor for positioning the plunger of said syringe, said sensor being electronically connected to said printed circuit and able to detect the position of maximum extraction of the plunger from the syringe cylinder.

The detection of this position of maximum extraction automatically and immediately activates the zeroing of the pressure gauge, allowing you to continue with the subsequent operations.

After the automatic reset of the pressure gauge, the operator must inject the air contained in the syringe into the sensor, pushing the plunger into said cylinder up to the maximum insertion position.

The new device comprises at least one element for locking said plunger in the position of maximum insertion into the syringe cylinder, to prevent the subsequent extraction of the plunger itself due to the pressure exerted on the pneumatic sensor alone.

In this way, the plunger remains in the position of maximum insertion during the subsequent operation of measuring the pressure exerted on said sensor, even without the aid of taps or valves that disconnect the syringe, as is the case in known devices.

The operator can then immediately proceed to measure the pressure exerted by the bandage immediately after injecting the air into the sensor.

To perform a new measurement, the operator must extract the plunger up to the maximum extraction position, at which the reset is automatically started again.

By extracting the plunger, air is sucked from inside said sensor cushion. To avoid creating depression conditions inside the sensor and the connecting tube, it is envisaged that at least one opening or through hole is made on said cylinder of the syringe, placed in a position between the two dead points of the piston stroke, so that, when said plunger is in the maximum extraction position, said hole puts the inside of the cylinder in communication with the external environment, restoring the atmospheric pressure conditions inside the connection pipe.

The reset of the pressure gauge therefore takes place when the pressure value inside said cylinder, at least in its part directly communicating with the tube, and inside said tube itself is equal to the atmospheric pressure.

To inject air into the sensor, for the subsequent measurement operation, it is therefore necessary to push the plunger into the cylinder until the plunger sealing plate exceeds this hole and reaches the top dead center of maximum insertion.

The component parts of said measurement unit are therefore all connected to each other and integrated into a single unit and the measurement can be repeated a plurality of times, without having to extract the sensor, which remains in place, without having to connect / disconnect the syringe at each injection of air and without having to directly act on the pressure gauge to reset it, since the reset operation takes place automatically upon detection of the maximum extraction position of the plunger and / or upon detection of the atmospheric pressure within the part of said cylinder directly connected to the tube, that is, when said plunger plate has been extracted beyond said hole.

The new device also allows the transmission of the collected data and measurements to a PC or other electronic device, both in real time, i.e. as the measurements are taken, and at a later time, since the data can be stored in a memory unit of the device itself.

The connection to the PC also allows you to perform many other operations, such as displaying the pressure trend during complete dynamic tests, patient data, memorization calculations, reporting and memorization without constraints on the duration of the test being performed.

It is also possible to provide that this device allows the selection of the dialogue language, to further facilitate the use and understanding by the operator.

The characteristics of the new device will be better clarified by the following description with reference to the drawing table, attached by way of non-limiting example.

Figure 1 schematizes the use of the new device, where the sensor (R), interposed between the skin and the compression bandage (B) applied to the limb (A) of the patient, is connected (Cl) to at least one unit measuring device (D) comprising a single housing body (DI) for a pressure gauge (M) and a syringe (S), as shown in the following fig. 6.

Figure la shows in detail, in section, the sensor (R) interposed between the limb (A) and the bandage (B).

Figure 2 schematically illustrates a possible solution for the connection (Cl 1), of the so-called "Luer Lock" type, of the external section, or external duct (Cl) of the duct (C) connecting the sensor (R) to the unit measurement (D) of the device.

Figures 3, 4, 5 schematically show the three operating phases to proceed with the measurement of the interface pressure, where the plunger (SI), initially in the position of maximum insertion (1) in figure 3, is extracted to the position of maximum extraction (2), at which the pressure gauge (M) is automatically reset, in figure 4. To measure the interface pressure, the plunger (S) is then brought back to the maximum insertion position (1), in figure 5, at which the data is detected, shown on the display (D2) of the measurement unit (D).

Figure 6 schematically shows the arrangement of the components of the measuring unit (D), which comprises a housing body (DI) of at least one manometer (M) and of at least one syringe (S), both connected to the sensor (R) by means of ducts (C21, C22, C2, Cl).

Figures 7 and 8 schematically show in particular the positions of maximum insertion (1) and maximum extraction (2) of the plunger (SI) of the syringe (S).

New pneumatically operated electronic device for measuring the interface pressure exerted by compression bandages (B) comprising at least one pneumatic sensor (R) connected by means of a preferably flexible tube or duct (C) to at least one measuring unit (D) , with manometer (M) and syringe (S) integrated in said single measuring unit (D).

As shown in figures 1 and la, said pneumatic sensor (R) comprises a pillow or cuff in thin, flexible and inextensible plastic film (RI), said pneumatic sensor (R) being able to be interposed between the skin and the bandage (B) of compression applied on the limb (A) of the patient, also in contact with the skin itself.

Said cushion or hose (RI) has a shape and size such that its internal volume (RII) is able to contain a predetermined volume of injected air such as to develop a known back pressure.

Said sensor (R) is hermetically connected (R2), by means of said duct (C), to said measurement unit (D).

In particular, said duct (C) comprises at least one external duct (Cl) to said measuring unit (D), for direct connection between said sensor (R) and said measuring unit (D), said external duct (Cl) being connected to said measuring unit (D) by means of an attachment (Cll), for example of the "Luer Lock" type shown in figure 2, with a special coupling sleeve (DII) integral with the housing body (DI) of said measuring unit (D) .

Said connection duct (C) also comprises a section or duct internal (C2) to said measurement unit (D), housed within said housing body (DI) and comprising at least one bifurcation (C23), where a first branch (C21 ) of the bifurcation is connected to said manometer (M) and a second branch (C22) of said bifurcation is connected to said syringe (S). The connections of said internal duct (C2) to said branches (C21, C22) of the bifurcation are direct, without valves or taps.

Said internal duct (C2) and said external duct (Cl) are hermetically connected to each other during the measurement, by means of said coupling sleeve (DII) and said connection (Cll), and in any case in a removable way to perform the sensor replacement operations (R) and the relative external duct (Cl) connected to it.

Said syringe (S) comprises a cylinder (S2) integral with said housing body (DI), inside which cylinder (S2) slides a plunger (SI) with stem (SII) equipped with a sealing plate (S14) to the internal walls (S22) of the cylinder (S2) and opposite end of the grip (S12) protruding from said housing body (DI).

Said piston (SI) slides inside said cylinder (S2) from a lower dead center, or position of maximum extraction (2), to a top dead center, or position of maximum insertion (1),

Said device further comprises at least one sensor for positioning the plunger (SI) of said syringe (S), said sensor being electronically connected to said electronic circuit (E) and able to detect the position of maximum extraction (2) of the plunger (SI) from the barrel (S2) of the syringe (S).

The detection of this position of maximum extraction (2) automatically and immediately activates the zeroing of the pressure gauge, allowing you to continue with the subsequent operations (Figure 4).

The plunger (SI) must then be pushed inside the cylinder (S2) up to the maximum insertion position (1), to inject a defined volume of air inside said pneumatic sensor (R).

The new device also comprises at least one element or device (S3) for locking said piston (SI) in the position of maximum insertion (1), comprising at least one protruding element (S31), elastically (S32) bound to said cylinder (S2) and / or to said housing body (DI).

Said protruding element (S31), insisting on the stem (SII) of said plunger (SI) of the syringe (S), is able to engage at least one recess (S13) made on said stem (SII) of the plunger (SI) when said recess (SI 3) is in a position corresponding to said protruding element (S31) itself, i.e. when said piston (SI) is in said position of maximum insertion (1), preventing the sliding of said piston (SI) itself due to the effect of the pressure exerted on said sensor (R).

In this way, said plunger (SI) remains in the position of maximum insertion (1) during the subsequent operation of measuring the pressure exerted on said pneumatic sensor (R) (figure 5), even without the aid of taps or valves that connect / disconnect the syringe (S), as occurs instead in known devices.

To perform a new measurement, the operator must slide said plunger (SI) of the syringe (S) to the maximum extraction position (2), at which the zeroing is automatically started again. To avoid creating depression conditions inside the pneumatic sensor (R) and the connection duct (C), it is envisaged that at least one opening or through hole (S21) is made on said cylinder (S2) of the syringe (S) ), placed between the two dead points upper (1) and lower (2) of the piston stroke, so that, when said piston (S) is in the maximum extraction position (2), said hole (S21) communicates the inside (S23) of the cylinder (S2) with the external environment, restoring the atmospheric pressure conditions inside the connection pipe (C) and inside the part (S23) of the cylinder (S2) in communication with said connection duct (C).

The reset of said pressure gauge (M) therefore takes place when the pressure value inside said cylinder (S2), at least in its part (S23) directly communicating with said duct (C) and inside said duct (C ) itself is equal to atmospheric pressure.

To inject the air into the sensor, for the subsequent measurement operation, it is therefore necessary to push said plunger (SI) into said cylinder (S2) until said plate (S14) sealing the plunger (SI) exceeds said hole ( S21) and reaches the maximum insertion top dead center (1).

The new device also comprises at least one interface port (El) of said electronic circuit (E), suitable for transmitting / receiving data, for connection with at least one external electronic device, such as a PC or other.

The new device is powered by rechargeable batteries (F) via socket (FI) to an external power supply network.

These are the schematic modalities sufficient for the skilled person to realize the invention, consequently, in concrete application there may be variations without prejudice to the substance of the innovative concept.

Therefore, with reference to the above description and the attached tables, the following claims are expressed.

Claims (16)

CLAIMS 1. Device for measuring the interface pressure exerted by medical compression bandages comprising: • at least one pneumatic sensor (R), designed to be interposed between the skin and the compression bandage (B) applied to the patient's limb (A); • at least one measurement unit (D), in turn comprising at least one pressure gauge (M), for measuring the pressure exerted on said sensor (R) and connected to said sensor (R) itself, and at least one electronic circuit ( E), connected to said pressure gauge (M), for detecting and displaying the data detected; • at least one syringe (S) or device for injecting air into said sensor (R) and connected to said sensor (R) itself; characterized in that said syringe (S) is constrained to said measurement unit (D). 2. Device for measuring the interface pressure as per claim 1, characterized in that said measuring unit (D) comprises a single housing body (DI) for said pressure gauge (M) and also for said syringe (S), and where at least the end gripping part (S12) of the plunger (SI) of said syringe (S) protrudes from said housing body (D1). 3. Device for measuring the interface pressure as per claims 1, 2, characterized in that said syringe (S) comprises: • at least one cylinder (S2) housed within said housing body (DI) and integral with it, said cylinder (S2) being connected to said sensor (R); • at least one piston (SI), translating inside said cylinder (S2) from a lower dead point, or position of maximum extraction (2), to a top dead point, or position of maximum insertion (1), said piston (SI) comprising at least one stem (SII), with a gripping end part (S12) and with at least one sealing plate (S14) on the walls (S22) of said cylinder (S2), and where at least one locking device (S3), insisting on said plunger (SI) of the syringe (S), prevents the plunger (SI) from sliding from said position of maximum insertion (1) into the cylinder (S2) of the syringe (S), due to the sole pressure exerted on said pneumatic sensor (R). 4. Device for measuring the interface pressure as per claim 3, characterized in that said locking device (S3) comprises at least one protruding element (S31), elastically (S32) constrained to said cylinder (S2) and / or to said housing body (DI) and insisting on the stem (SII) of said plunger (SI) of the syringe (S), and where said protruding element (S31) is able to engage at least one recess (S13) made on said stem (SII) of the piston (SI) when said recess (S13) is in a position corresponding to said protruding element (S31) itself, i.e. when said piston (SI) is in the position of maximum insertion (1), preventing the sliding of said piston (SI ) itself due to the effect of the pressure exerted on said sensor (R). 5. Device for measuring the interface pressure as per claims 1, 2, 3, 4, characterized in that it comprises at least one sensor for positioning said plunger (SI) of the syringe (S), said sensor being electronically connected to said electronic circuit (E) and able to detect at least the position of maximum extraction (2) of said plunger (SI) from the cylinder (S2) of the syringe (S), and where the detection of this position of maximum extraction (2) causes Γ automatic zeroing of said pressure gauge (M). 6. Device for measuring the interface pressure as per claims 1, 2, 3, 4, 5, characterized in that it comprises at least one duct (C) for connecting said sensor (R) to said pressure gauge (M) and to said syringe (S), said duct (C) comprising: • at least one external duct (Cl) to said measurement unit (D), for connection between said sensor (R) and said measurement unit (D) itself; • at least one internal duct (C2) to said measuring unit (D), housed within said housing body (DI) and comprising at least one bifurcation (C23), where a first branch (C21) of the bifurcation is connected to said manometer ( M) and a second branch (C22) of said bifurcation is connected to said syringe (S), and where the connections of said internal duct (C2) to said branches (C21, C22) of the bifurcation are direct, without valves or taps. 7. Device for measuring the interface pressure as per claim 6, characterized in that said external duct (Cl) said internal duct (C2) can be connected to each other (DII, Cll) hermetically during the measurement and in any case in a removable, for replacing said sensor (R) and / or said external duct (Cl) and / or said internal duct (C2). 8. Device for measuring the interface pressure as per the preceding claims, characterized in that said plunger (SI) slides from the position of maximum insertion (1) into the cylinder (S2) of said syringe (S) by effect of a manual action on the plunger (SI) itself. 9. Device for measuring the interface pressure as per the preceding claims, characterized in that on the wall (S22) of the cylinder (S2) of said syringe (S), between the two upper (1) and lower (2) dead points of the stroke of said piston (SI) in the cylinder (S2) itself, at least one opening or through hole (S21) is made, communicating with the outside Γ, to restore the atmospheric pressure inside said connection duct (C) and inside said cylinder (S2), in the part (S23) communicating with said duct (C2) itself, when said piston (SI) is in the maximum extraction position (2). 10. Device for measuring the interface pressure as per claims 5, 9, characterized in that said zeroing of the pressure gauge (M) occurs automatically when said piston positioning sensor (SI) detects the position of maximum extraction (2 ) and when said manometer (M) detects the atmospheric pressure value inside said connection duct (C) and inside said cylinder (S2), in the part (S23) communicating with said duct (C2) itself. 11. Device for measuring the interface pressure as per the preceding claims, characterized in that said sensor (R) comprises at least one pillow or hose made of flexible and hermetically connected plastic film (RI) (R2), by means of said connection duct (C), to said measurement unit (D), and where said cushion or hose has an internal volume (RII) able to contain a predetermined volume of injected air such as to develop a known back pressure. 12. Device for measuring the interface pressure as per the preceding claims, characterized by the fact that said electronic circuit (E) comprises at least one memory unit suitable for storing n interface pressure detection data. 13. Device for measuring the interface pressure as per the preceding claims, characterized in that said electronic circuit (E) comprises at least one interface port (El) suitable for data transmission / reception, for connection with at least one electronic device external. 14. Device for measuring the interface pressure as per the preceding claims, characterized in that it comprises one or more supply accumulators (F), said accumulators (F) being electrically rechargeable by means of a socket (FI) to an external power supply network. 15. Device for measuring the interface pressure as per the preceding claims, characterized in that it comprises at least one display (D2) for displaying the detected data, functions, options, settings, etc. 16. Device for measuring the interface pressure as per the preceding claims, characterized in that it allows the selection of the dialogue language.