EXTREMITIES OF A USER.

The present invention relates to the field of the systems used to regulate and protect blood flow to limbs.

Specifically, the present invention discloses a regulation and protection system comprising a coverall equipped with shrinking means placed at the roots of the limbs, sensor means for assessing the status of a user who wears the coverall, and a control unit equipped with software means capable of processing the data coming from the sensors and identifying any altered or critical physiological conditions whereby any interventions would be necessary, a remotely connected telematic device, and a microphonic sensor or push-button for voice or manual control.

Present status of the art

Numerous devices are present in the present status of the art for an automatic shrinking aiming at regulating blood flow to limbs and at protecting from severe haemorrhagic injuries, and numerous patent documents are also present which disclose devices for regulating blood pressure and for intervention in the case of haemorrhagic injuries.

Patent document US2021106341 discloses a wearable device which comprises a tourniquet. The tourniquet comprises an inflatable chamber and is configured for occluding the blood flow in an artery of that who wears it. The wearable device comprises a compressed gas source. The wearable device comprises an inlet valve in communication with the compressed gas source, and an outlet valve in communication with the inflatable chamber. The wearable device comprises at least one fixed pressure regulator.

Patent document US2019307465 discloses a wearable device which comprises a tourniquet configured for occluding blood flow in an artery of that who wears it. The tourniquet comprises at least one base plate; two anchoring points connected to a base plate and configured for anchoring a first end of either tourniquet; a tunnel band comprising two tourniquet guides connected to a first end of the tunnel band, each configured for guiding either tourniquet; and a tensioner mechanism connected to one of the at least one base plate and comprising a reel configured for receiving a second end of each of the two tourniquets, and a handle configured for manually winding a portion of at least one of the two tourniquets on the reel. The wearable device comprises a quick release connector used to release the wearable article connected to the tourniquet and configured for removably connecting to a wearable article.

Patent document CN110393570 discloses a wearable device for skilled personnel performing self-aid functions and concerning the technical sector of self-aid equipment for skilled personnel. The wearable device for skilled personnel performing self-aid functions comprises a long-sleeve jacked and trousers; the haemostatic devices are secured to the upper part of the arms on both sides of the long-sleeve jacket and at the peripheries of the trousers, every haemostatic device includes two tourniquets and functional bases, the two tourniquets are glued together and include a non tensionable peripheral tourniquet and an endocyclic inflatable tourniquet, the functional base is mounted on a non tensioned tourniquet and includes an integrated inflation device, a pressure sensor, a timing module, a power module, and an external alert module and a display module, an inflation joint in the inflation device penetrates the non tensioned tourniquet to inflate the inflation tourniquet and a bridge inflation belt which can be rapidly inflated to form a tourniquet, the neck support is secured to a collar of the long- sleeve jacket.

In the present status of the art, the devices provided to some categories of workers (for example soldiers, policemen) comprise tourniquets provided together with their equipment or with service means or medical kits.

These systems are affected by the following limitations:

- in the case of an emergency, the system might not be immediately available for the injured person or might go lost during an accident;

- the subject might not be in a position to wear or shrink the system without any help, because of the received injuries;

- these systems are not capable of sending alarm messages to health operators. Furthermore, said systems are not capable of assessing the subject’s conditions nor identifying with a high accuracy the probability of an haemorrhagic-like event, whereby a shrinking intervention would be necessary at a pressure greater than the user’s systolic one.

The systems used to prevent haemorrhages might cause major problems in the case of a false positive and a simultaneous delayed intervention of first aid, because of a reduced blood flow to the concerned limb for an extended period of time, which consequently would face necrosis problems in the tissues and consequently could led to a probable amputation of the concerned limb.

A need comes out from these problems associated with the present status of the art for setting up an intelligent system capable of identifying with a high accuracy any variations in a user’s parameters referrable to a traumatic event that might be in turn referrable to a haemorrhagic injury and, in the case of a false positive, a need arises of providing a system capable of limiting damages possibly caused by a reduced blood flow for an even extended period of time, in case of delay of rescue. The disadvantages of the known prior art are overcome by an intelligent system for regulating blood flow to one or more extremities, comprising four integrated shrinking devices integrated in a coverall; said system uses sensors which it is equipped with to assess values that allow to process an index of probability both of an alteration situation in the cardiovascular system (for example, under extreme environmental conditions, e.g. in the presence of very intense cold, very intense hot, high altitude, and, for example, even high acceleration levels that might occur upon driving aircrafts) and a probable injury of a haemorrhagic type whereby the shrinking system might shrink up to a pressure greater than the subject’s systolic pressure, thus reducing blood flow to the affected limb to such extent as to prevent a subject’s death by haemorrhage. The system is capable of correlating the altered physiological conditions to the probability of a haemorrhagic injury, also thanks to the identification of possible tears in the coverall worn by a user, thanks to the presence of appropriated sensors.

Brief description of the invention

A purpose of the present invention is to provide an intelligent system capable of regulating blood flow to one or more limbs on the basis of a monitoring made on values related to the health status of the user who wears the coverall.

In particular, the device according to the invention primarly solves the technical problem of monitoring the subject’s pressure together with other parameters related to the health conditions of a subject who wears the coverall, by identifying an index of probability of altered physiological conditions and automatically regulating the blood flow to the limbs if necessary.

Whenever said index is greater than or equal to a threshold value, there is a greater probability of an injury of a haemorrhagic type; in these conditions, the system will operate in order to shrink the limb involved in a possible injury (the limb being identified by way of sensors responsible for detecting tears, integrated in the coverall), so as to prevent the patient’s health conditions due to a haemorrhage from worsening or his/her death by haemorrhage.

The system according to the invention is configured in such a way as to comprise a coverall or technical clothing comprising four automatic shrinking systems placed at the roots of the limbs (Figs. 1 , 3). In the case of an injury, the system, after being activated by the user, is capable of automatically shrink around the limb up to a pressure greater than the subject’s systolic pressure, thus causing a stoppage in the blood flow downstream, hence giving more time to the injured people to receive an appropriate medical care.

Once activated, the system is also capable of automatically sending alarm messages to health operators by specifying the injured people’s (GPS) position and the system activation time.

The system measures a number of physiological parameters, such as heart rate, systolic pressure, body temperature, and stress status, and correlate them for calculating the probability of a possible injury to limbs, and in any case, and wherever appropriate, informing the dedicated staff on a possible alteration of the health/stress status/altered physiological conditions of the user.

The system integrates coverall tear detection sensors in order to identify a possible tearing of the coverall at limbs, thus increasing the system capability of autonomously identifying whether an intervention is required in the case of an acute haemorrhagic injury.

Brief description of the fiqures

Other advantages, characteristics, and mode of use of the device according to the present invention will be apparent from the following detailed description of one embodiment, which is given for exemplary, non-limitative purposes only and with a special reference to the attached figures, wherein:

Figure 1 - a schematic view of the system as a whole;

Figure 2 - an axonometric view of one preferred embodiment of a shrinking means, a detail of which specifically shows a worm-screw system of a preferred embodiment;

Figure 3 - a view of an intelligent coverall (2) provided with sensors and four shrinking means, in turn provided with pressure sensors;

In the figures, as they are presented, the sensors (not shown), as well as the control unit, are indicated in a purely schematically manner.

Leqend

1 . Intelligent device according to the invention;

2. Coverall worn by a user;

3. Shrinking means;

4. Operating means of shrinking means;

4.1 worm-screw operating means;

5. Sensor means for measuring blood pressure and the pressure exerted by said shrinking means;

6. Inertial platform;

7. Tear detection sensor means;

7.1 Optical fibres integrated in said coverall 2;

7.2 Resistive grid integrated in said coverall 2;

8. Body temperature sensor;

9. Optical sensor for measuring heart rate and/or oxygen saturation in the blood;

10. Electrochemical sensor for pH detection;

11 . Perspiration and stress level sensors; 12. Control unit;

13. Microphonic sensor;

14. Manual control for external push-button;

15. Remotely connected telematic device;

16. Push-buttom for activating the manual control of the shrinking means 3.

Detailed description of the invention

The present invention discloses an intelligent device 1 for regulating blood flow to extremities, both in slightly altered physiological conditions and in extreme conditions. The intelligent system 1 according to the invention comprises:

- at least one coverall 2 provided with: o four shrinking means 3 integrated internally thereto and removably connected thereto, each positioned at the root of the limbs and provided with means 4 for operating said shrinking means and provided with sensor means 5 for measuring the pressure exerted by them onto every limb and for measuring blood pressure, at least one of which provided with at least one inertial platform 6 for detecting changes of movement of said user who wears the coverall 2, and at least one push-button for activating the manual control 16; o sensor means 7 for detecting tears at the ends of said coverall downstream of said shrinking means 3; o sensor means for detecting the general health conditions of the user wearing said coverall 2 such as, jointly or alternatively, at least one body temperature sensor 8, at least one optical sensor for assessing heart rate and/or oxygen saturation 9, at least one electrochemical sensor for pH detection 10, and one or several sensors for perspiration and stress level detection 11 ; o electronic means integrated internally to the coverall and removably connected thereto, comprising a control unit 12, electronic processing means on board of said control unit, geolocalization means for identifying the user’s position, RAM memory means and data memory means, a power battery and at least one device for sending/receiving data for connecting to a network, configured for wirelessly sending/receiving a signal;

- at least one microphonic sensor 13 for voice control and/or at least one pushbutton 14 for operating a manual control;

- at least one remotely connected telematic device 15.

This system is characterized in that said shrinking means are integrated in the coverall, so as not to require any user’s intervention for their operation, being thus it possible for them to be operated automatically.

Said shrinking means are also provided with a push-button 16 for manual activation.

Therefore, the system is also characterized in that it is implemented by electronic processing means on board of said control unit 12, which are provided with software means for processing at least one first value related to the general health conditions of the user who wears the coverall, detected by said sensor means 5, 8, 9, 10, 11 , and at least one second value related to the conditions of said coverall 2 detected by said sensor means 7 and to variations of movement detected by said at least one inertial platform, in order to obtain an index of probability of altered physiological conditions related to blood flow and to cardiovascular system, in conjunction with probable traumatic events having affected the user who wears the coverall 2 and/or extreme environmental conditions, in order to send a command to at least one shrinking means 3 for regulating the blood flow of a user’s limbs, on the basis of said index.

In one preferred embodiment of the invention, said software means are configured in such a way that, whenever said index is greater than or equal to a predetermined threshold value, i.e. whenever there is a greater probability that there is a haemorrhagic injury, they send a request for confirmation to said user in the form of an audible alarm and/or vibration, in order to inform him/her that a shrinking procedure has been initiated because of a probable traumatic event of a haemorrhagic nature affecting one or several limbs in correspondence with which a tear has been detected in the coverall 2. Such audible confirmation and/or vibration sent by said control unit 12 aims to identify false alarms so that, if there is no haemorrhagic injury that requires a shrinking and the user is conscious, the latter has the capability of stopping the shrinking procedure; if the user does not stop the shrinking procedure, either because he/she is affected by a haemorrhagic injury or because he/she lost consciousness and is not in a position to answer, the system activates a shrinking procedure and remotely informs the telematic device and activates a controlled periodical release of said shrinking means 3, for the sake of safety, so as to allow for a minimal blood flow, if the shrinking time exceeds a predetermined threshold value or help is not received timely.

In a further embodiment of the invention, the request for confirmation related to the shrinking procedure is sent to a wearable device of a smartband type or any other device connectable to said control unit 12.

In further embodiments of the invention, said sensor means 7 are optical fibres 7.1 or a resistive grid 7.2 integrated in the fabric of said coverall 2 for detecting tears at the ends of said coverall downstream of said shrinking means 3.

In these possible embodiments, the resistive or optical band provides information about the integrity of the coverall at the extremities or whether it has been torn; this information provided by these sensors to the control unit increases the system’s capability of autonomously and with a certain accuracy identifying whether a life-saving intervention would be convenient, i.e. whether a shrinkage to a pressure greater than the subject’s systolic pressure would be necessary in order to prevent a death by haemorrhage.

The resistive/optical band can be made from a variety of materials having specific characteristics (e.g. fire-proof, protective) which in any case offer an additional protection layer to users. In different circumstances, the system quantifies and properly controls the shrinking pressure exerted.

The sensor means used for assessing the general health conditions of the user who wears the coverall might be inserted altogether in an embodiment of the invention or be associated with each other so as to prefer an association of some sensors instead of others; concerning perspiration assessment, reference is made to a set of sensors which allow to assess perspiration quality.

The value detected by said sensor means 7, in conjunction with what detected by said at least one inertial platform 6 aiming at detecting major variations of movement of said user who wears the coverall 2, makes it even more probable the possibility of detecting an alteration in the physiological conditions of the user who wears the coverall following an accident or a sudden variation of the user’s movement, which might have caused an injury of a haemorrhagic type.

The software means send at least one command to said at least one shrinking means up to reaching a pressure greater than the systolic pressure, in case of no answer from said user and/or no stoppage of the shrinking procedure by said user; in this event, the user has few seconds at his/her disposal to answer and possibly stop the shrinking procedure.

After initiating a shrinking procedure, the system is preset to send a controlled periodical release command to said shrinking means 3, so as to allow for a minimal blood flow, should the shrinking time exceed a predetermined threshold value; that is to say, if the aid operations to the injured person are late, the system is provided with a safety system that allows a controlled periodical release so as to allow for a minimal blood flow to a limb and minimize the risk of necrosis of thereof and its subsequent amputation.

Therefore, said software means are configured for sending a controlled periodical release command to said shrinking means 3 so as to allow for minimal blood flow should the shrinking time exceed a predetermined threshold value.

In the meantime, the system sends an alarm signal to a remotely connected telematic device 15 after initiating the shrinking procedure, so as to inform and trigger a help by skilled personnel.

In a further embodiment of the system according to the invention, the monitoring by way of a coverall worn by a user only takes place by means of sensors which monitor the subject’s health status; in this further embodiment, the sensor means 7 used for detecting tears at the ends of said coverall upstream of said shrinking means 3 will not be equipped.

In the above-mentioned embodiment, which also represents the preferred embodiment, an automatic activation mode is described.

However, there are other embodiments that concern the activation of the shrinking device: the shrinking device can be activated through a physical user’s control (for example a push-button), an external push-button, or one integrated in the coverall, in particular with the shrinking means; in this event, the system automatically reaches the predetermined shrinking value to subsequently autonomously activate the controlled periodical release function (semiautomatic mode);

- by way of a user’s voice control; in this event, the system automatically reaches the predetermined shrinking value to subsequently autonomously activate the controlled periodical release function (semi-automatic mode);

- by way of a remote control (activated by a rescue operating unit in close proximity or by an operation centre); in this event, the system automatically reaches the predetermined shrinking value to subsequently autonomously activate the controlled periodical release function (semi-automatic mode);

- by way of a user’s manual control. In this event, the user manually operates the system (e.g. by turning a handle) which in any case provides information about the pressure level applied and recommends the release ranges to the user, who will manually operate them (manual mode).

The system is thus preset for sending a command to said at least one shrinking means both via a microphonic sensor 13 and/or said external push-button and/or said pushbutton integrated in the coverall 16; or by way of said remotely connected telematic device 15.

Every shrinking device illustrated in Fig. 2 can be activated by a operating means 4 used for said shrinking means 3, which is either a micromotor, a magnet system, or other possible solutions; in a preferred embodiment, the mechanical system is of a worm-screw type 4.1 .

In a simpler and more cost-effective configuration, a small ratchet device might be simply present, consisting of a wheel that would only allow for manual shrinking. The present invention also describes a procedure for regulating blood flow to one or several extremities of a user, operated by way of the system 1 , comprising the following operating steps:

- detecting at least one first value related to the general health conditions of the user who wears the coverall (2), by way of said sensor means 5, 8, 9, 10, 11 ;

- detecting a second value related to the conditions of the coverall with respect to changes of movement of the user who wears the coverall, by way of the sensor means 7 for detecting tears at the extremities of said coverall 2 and by way of said at least one inertial platform 6;

- processing, by way of said software means resident in said electronic processing means in the control unit, said at least one first, respectively second, parameter related to any altered physiological conditions concerning blood flow and cardiovascular system associated with a probable traumatic event affecting said user who wears the coverall 2;

- obtaining an index of probability of altered physiological conditions concerning blood flow and cardiovascular system;

- sending a command to at least one shrinking means 3 for regulating blood flow to the limbs of the user who wears the coverall 2, up to reaching a given blood pressure value predetermined according to the assessed conditions, on the basis of said index of probability.

The operating procedure of said system comprises the following further operating steps:

- forwarding an advise of confirmation to said user, on the basis of said index of probability, if greater than or equal to a predetermined threshold value, by way of an audible alarm and/or vibration, in order to inform him/her that a shrinking procedure has been initiated because of a probable traumatic event of a haemorrhagic nature affecting one or several limbs in correspondence with which a tear in the coverall 2 has been detected, and, if necessary, making said user stop the shrinking procedure;

- sending a command to said at least one shrinking means 3 in case of no answer from said user and/or no initiation of a shrinking stoppage procedure by said user up to reaching a pressure greater than the subject’s systolic pressure. After securing the patient, the procedure comprises a step whereby an alarm signal is sent to at least one remotely connected telematic device 15, so as to allow for an immediate rescue intervention.

Finally, the procedure comprises a further step whereby a controlled periodical release command is sent to said shrinking means 3, so as to allow for a minimal blood flow if the shrinking time exceeds a predetermined threshold value, i.e. if no help is received within a fast and immediate time.

The system according to the invention features several advantages.

The problem of these systems whereby blood circulation is regulated by way of shrinking means is in that they might lead to identifying false positives, thus creating severe problems to the user’s limbs, in that they block the circulation to the limb and consequently cause a necrosis of the tissues.

However, given the severity of the consequences that a non-timely treated haemorrhagic injury might have, the system according to the invention is extremely valid even in the case of a false alarm (i.e. an unnecessary activation) because of the following considerations: first of all, a false alarm is always preferrable to a no-alarm, secondly the system does not become effective before sending a signal to the user who, in the case of a false alarm, can stop the shrinking procedure before the latter is activated.

The probability of a false alarm, even though present, is moderate in the system according to the invention, in that the activation logic takes different parameters (coverall tearing at limbs, heart rate, impacts, arterial pressure, stress level, perspiration) into account which, if correlated (even if not all together), might be highly indicative.

Furthermore, the system is also provided with a supplementary safety system; even in the case of an unnecessary activation, the user being unconscious, i.e should the user not be in a position to stop the shrinking procedure in the case of a false alarm, the system, once tightened, activates a programmed periodical release feature to prevent a limb from necrotizing, thus preventing any sanitary risks for users.

The scope of the invention is susceptible of numerous modifications and variants, all falling within inventive concept set forth in the attached claims.

All details might be replaced by other technically equivalent elements, depending on requirements, without departing from the scope of protection of the present invention. Even though the scope has been described by making a special reference to the attached figures, the reference numerals used in the description and in the claims are used for making the invention more understandable, but they do not constitute any limitations to the claimed scope of protection.