Haemostatic system

Abstract

The invention relates to devices for temporarily bleeding control, and can be used in providing first aid to persons with injuries accompanied by bleeding, as well as in traumatic amputation or destruction of limbs. A haemostatic system comprising a compression element connected via an air line to a compressor and conductive elements with a control module, in which a pneumatic cuff is used as the compression element, the compressor with power elements and the control module are mounted and secured in the pneumatic cuff, while the system additionally has a pressure sensor connected to the compressor and placed inside the pneumatic cuff, and a timer for fixing the activation time; the conductive elements are made of carbon fiber and secured to the lower part of the limb by means of a strap. The claimed haemostatic system is autonomous, small-sized, with a closed air system, convenient to use and provides the possibility of uniform distribution of pressure on soft tissues and vessels.

Description

[0001] HAEMOSTATIC SYSTEM

[0002] The invention relates to medical equipment, in particular, to devices for temporarily bleeding control, and can be used to compress the main blood vessels of the limbs and torso, in particular, when providing first aid to persons with injuries accompanied by bleeding, as well as with traumatic amputation or destruction of limbs.

[0003] There is a rubber tourniquet ("Esmarch's tourniquet") is known, which is a rubber band with polyethylene buttons. The disadvantages of this tourniquet are its sensitivity to ambient temperatures (it becomes rigid at temperatures below 5°C, so the tourniquet requires special storage conditions), as well as the fact that it often breaks at the attachment points, slips in wet hands, and can injure the skin (which is why it is used only over clothing or a special fabric layer). When used during surgical operations, the tourniquet strongly compresses the limbs, and the doctor cannot control the compression degree of vessels in the tissues [https: / / paramedic.ua / instrukcziya-po-ispolzovaniyu-zhguta-esmarkha].

[0004] However, this design causes severe pain when used due to abnormal pressure on the tissues, and also it is very often accompanied by "tourniquet syndrome". The users of this tourniquet require to have certain skills.

[0005] There is a cloth tourniquet (so-called "tourniquet"), which is. a Velcro strap made of dense, usually synthetic material; it has a platform with a reversible rod and hooks for fixing the rod during limb traction. It also contains a beacon to indicate the time of application [https: / / ru.wikipedia.org / wiki / Hemostatic tourniquet].

[0006] There are many other options for performing a cloth tourniquet, including "Sich", "Ukrospas", etc. [UA103336 U, IPC: A61B 17 / 12 (2006.01), published on 10.12.2015, bull. No. 23; UA101341 U, IPC: A61L 17 / 00, published on 10.09.2015, bull. No. 17],

[0007] Such tourniquet designs allow you to apply a tourniquet to yourself.

[0008] The disadvantage of these tourniquets is the inability to operate automatically, which can lead to the death of the injured person in the event of loss of consciousness or untimely / inept use. Also, their application is accompanied by pain and tourniquet syndrome.

[0009] There is known individual combat garment "BOETS” containing uniforms, underwear and outerwear and a life support system with a medical aid kit, which additionally contains a "removable" or "permanent" individual device for temporarily blood flow cessation in the limb(s) and an information carrier indicating the time of stopping blood flow in the limb(s) and the owner's personal data. The "removable" version of this device includes a bandage-cover, which is put on in advance over the sleeves and / or legs of military clothing. The cover contains elements for compressing the soft tissues of the limbs and an information carrier represented by a waterproof pocket or a sealed hollow sleeve for a note indicating the time of blood flow cessation in the limb(s) and the owner's personal data. The "permanent" version of the device involves the device, carrier, cover with elements for compressing the soft tissues of the limbs into the structural details of the sleeves or legs of military clothing [RU43739 Ul, IPC: A41D 29 / 00 (2000.01), published on 10.02.2005, bull. No. 4],

[0010] The disadvantage of these tourniquets is the inability to operate automatically, which can lead to the death of the injured person in the event of loss of consciousness.

[0011] There is a haemostatic electronic-pneumatic tourniquet, comprising a cuff with a pneumatic chamber and an electro-pneumatic unit. The cuff has a conical shape and its width is at least 8 cm. The electronic-pneumatic unit contains an air compressor, pressure sensor, microcontroller, pneumatic valve, liquid crystal display, battery, pneumatic splitter and acoustic alarm. The electronic-pneumatic unit has three buttons: a power button, a pressure selection and start button for the upper extremity, and a pressure selection and start button for the lower extremity. The microcontroller is designed to provide a set value of cuff pressure, output information about the time elapsed since the device was turned on and the cuff pressure value, automatically inflate the cuff pressure to 200 mm Hg for the upper limb and 300 mm Hg for the lower limb, automatically maintain the pressure for at least 4 hours, and generate an audible signal after 2 hours of operation. The pneumatic splitter is intended for combining the electronic unit with the cuff and regulating the air injection by the compressor under control of a pressure sensor [RU134419 Ul, IPC: A61B 17 / 12 (2006.01), published on 20.11.2013, bull. No. 32],

[0012] The disadvantage of this tourniquet is the inability to simultaneously compress several parts of the body, as well as the instability of the device in case of damage to the pneumatic chamber.

[0013] There is a haemostatic pneumatic tourniquet, which includes at least one cuff with a pneumatic chamber connected to a control unit. The control unit contains at least two interconnected pneumatic valves connected to the cuff, an air compressor with a power source, a microcontroller and means for indicating the pressure of the pneumatic chamber, and also contains a receiver between the compressor and at least two pneumatic valves and one relief valve. At the same time, the compressor is connected to the receiver directly, and the relief valve is designed to ensure the simultaneous opening of all pneumatic valves [RU2777688 Cl, IPC: A61B 17 / 135 (2006.01), published on 08.08.2022, bull. No. 22],

[0014] The disadvantage of this device is the complexity and space limitation of the design. There is an electronic-pneumatic haemostatic tourniquet, comprising at least three pneumatic cuffs designed to be worn on a part of the patient's body and equipped with pressure measuring means, an air compressor pneumatically connected to each cuff, designed to supply compressed air to them, and a microcontroller electrically connected to the air compressor and the pressure measuring means with the ability to deliver control signals to them for controlling the supply of compressed air to the cuffs while creating and maintaining the required pressure in each of them.

[0015] At the same time:

[0016] - at least two cuffs are designed to be worn on the patient's limb;

[0017] - at least one cuff is designed to be worn on the patient's torso;

[0018] - at least one pulse wave monitoring sensor configured to continuously track the pulse wave in an isolated part of the patient's body is connected to the microcontroller;

[0019] - the pulse wave control sensor is an optical sensor that operates on the principle of photoplethysmography and is designed to be installed on the patient's limb finger or on the patient's chest;

[0020] - the microcontroller is connected to a battery to ensure autonomous operation of the device in the event of a power failure;

[0021] - a pneumatic valve is installed between the air compressor and at least one cuff, which is electrically connected to a microcontroller with the ability to receive control signals from it [RU168288 Ul, IPC: A61B 17 / 12 (2006.01), published on 26.01.2017, bull. No. 3],

[0022] The disadvantages of this device are the complexity of the design, the presence of a common control unit and compressor for all cuffs, which leads to the inoperability of the entire system due to the failure of any of the functional units of the control unit or compressor.

[0023] There is a protective coverall with an autonomous bleeding control system, which is a body-worn compression coverall, the upper part of which is made in the form of a shirt with sleeves, the lower part is made in the form of pants. The haemostatic system includes tourniquets, air lines, compressor, compressor control module, and wires. There are shoulder tourniquets on the sleeves in the area of each shoulder, and thigh tourniquets are placed on the pants in the groin area. The femoral and shoulder tourniquets are connected via air lines to the compressor. The tourniquets and air lines have a dense base. They are hollow inside with the possibility of filling them with air. The control module is connected to the compressor. The control module and compressor are located on the belt in the front of the coveralls. The control module has four buttons for supplying air to the structural space of the corresponding tourniquet. The control module on the front and back sides of the coverall is connected by wires on the sleeves and pants. The haemostatic system is activated by the control module when the wires on the sleeves or pants break, or by using the buttons on the control unit. The system can perform tourniquet compression of either one or two upper limbs, or one or two lower limbs, or all four limbs at once [RU2732720 Cl, IPC: A41D 13 / 00 (2006.01), published on 22.09.2020, bull. No. 27],

[0024] This haemostatic system was chosen as the closest analogue.

[0025] The closest analogue and the claimed haemostatic system have the following common features:

[0026] - compression element;

[0027] - compressor;

[0028] - control module;

[0029] - air line;

[0030] - conductive elements (wires);

[0031] - the compression element is connected via an air line to a compressor, which is connected to a control module for conductive elements attached to the limbs.

[0032] The disadvantages of this haemostatic system are its complex design, the presence of a common control module and compressor for all cuffs, which leads to the inoperability of the entire system due to the failure of any of the functional units of the control module or compressor, in particular:

[0033] - pressure is transmitted to a hollow, rather narrow tourniquet (small compression area);

[0034] - in the event of bleeding from a wound, which causes damaged wires, the control module automatically activates the compressor;

[0035] - is a separate uniform (clothing) with its own additional weight;

[0036] - there is no pressure relief and maintenance mechanism, no pressure sensors, no timer and no tonometer.

[0037] The invention is based on the task of creating a haemostatic' system in which, by introducing new features, including changing the shape of the connections between elements, the haemostatic system can be autonomous, its dimensions can be reduced, it can be used with ease, and it can evenly distribute pressure on soft tissues and vessels.

[0038] The problem is solved by the fact that a haemostatic, system, which contains a compression element connected via an air line to a compressor, with the compressor being connected by conductive elements to a control module, according to the invention, uses a pneumatic cuff as a compression element, a compressor with a power supply element and a control module that are mounted and fixed in the pneumatic cuff; and the system additionally contains a pressure sensor connected to the compressor and placed inside the pneumatic cuff, as well as a timer for fixing the activation time; and the conductive elements that form the rupture contour are connected to straps made of carbon fiber and fixed to the lower part of the limb.

[0039] In a haemostatic system, the control module can be manufactured on microcontrollers with the ability to add additional sensors, including temperature, saturation, and pulse sensors.

[0040] The haemostatic system can be worked out as an element of clothing and completed with an additional element of cuff protection made of wear-resistant woven materials, such as Kevlar (aramid).

[0041] The haemostatic system can be made with an arm-leg jumper.

[0042] Advantages of the claimed haemostatic system.

[0043] 1. Modularity. The claimed system consists of interchangeable modular elements, which makes it possible to ensure uniform distribution of its weight. Power supplies (for example 6 -H2 V) have low power. The control module is placed on the outer (front) surface of the cuff, which ensures convenient use. This also makes it possible to easily replace damaged elements. In the over-the-top version, the control module (can be) placed on the outer (front) surface of the uniform (clothing), making it a full-fledged independent device.

[0044] 2. Compactness. The weight of the system does not exceed 300 g, making it possible to use it as an individual device, equipped (inserted) into uniforms. Can be used as a separate element to stop bleeding. Depending on the modification, the fastening changes.

[0045] 3. Autonomy. After the “circuit is broken,” the system operates without human intervention, which in most cases is crucial in the event of loss of consciousness or concussion. When used manually, it is enough to press the button once or tear the strap and then the device will do everything "by itself.” There is no need to follow the application technique, nor is there any need to monitor the haemostatic system during operation, just apply and turn it on.

[0046] 4. Protection from injury. The embossing area of a pneumatic cuff is much wider than when applying a tourniquet or constrictor. As shown by testing of prototypes, the width of the pneumatic cuff for the upper extremities of 15 cm and for the lower extremities of 20 cm is optimal for ensuring uniform distribution of pressure on soft tissues and the neurovascular bundle, with subsequent reduction of the traumatic effect of bleeding control itself (which is often the cause of post-traumatic plexitis with subsequent pain and orthopedic syndrome). Also, according to user reviews, the lack of pronounced pain syndrome from applying the cuff comes to the fore, but with the achievement of the ultimate goal of stopping blood circulation in the limb.

[0047] 5. The carbon fiber from which the conductive elements are made is a fireproof, anti- allergenic, wear-resistant, and conductive material. The invention is illustrated by drawings, where

[0048] Figure 1 - diagram of the haemostatic system;

[0049] Figure 2 - modular control diagram;

[0050] Figure 3 - photo of the straps;

[0051] Figure 4 - an example of the haemostatic system location on human limbs.

[0052] Designations on drawings:

[0053] 1 - pneumatic chamber;

[0054] 2 - air line;

[0055] 3 - fastening of straps to conductive elements;

[0056] 4 - compressor;

[0057] 5 - compressor control module with a break and pressure control contour;

[0058] 6 - battery (rechargeable battery);

[0059] 7 - nipple;

[0060] 8 - power on / off button;

[0061] 9 - button for turning on the backlight of the timer for fixing the operating time;

[0062] 10 - pumping on button;

[0063] 11 - inflation resistor;

[0064] 12 - pressure sensor;

[0065] 1 - display module;

[0066] 14 - mechanical pressure relief valve;

[0067] 15 - time / pressure indicator;

[0068] 16 - ’arm-leg’ switch;

[0069] 17 - conductive elements;

[0070] 18 - start button (manual activation);

[0071] 19 - cuff (as an assembly of the haemostatic system);

[0072] 20 - straps.

[0073] In Figure 1: pneumatic chamber (air chamber) 1 is connected through air line 2 to compressor 4 via nipple 7. A mechanical pressure relief valve 14 is located on the air line 2, in case of protecting pneumatic chambers from pressure increase above the calculated norm, as well as direct pressure relief for removing the cuff 19. Compressor 4 is connected to module controlling compressor 5 and break contour 3, and to boost resistor 11 (for slow increase of pumping value), while electrical connection is made using conductive elements 17. The compressor control module 5 is connected by conductive elements 17 through the mount 3 to the straps 20 that are attached to the lower part of the limb. In this case, the straps 20 are made of carbon fiber. Compressor 4 with battery (accumulator) 6 are placed in the middle of cuff 19.

[0074] The module controlling compressor 5 and break contour contains a power on / off button 8. The display control module 13 with the indicator 15 and the indicator backlight button 9 contains a button 10 - turning on the pumping. Additionally, the pumping value can be set using the inflation resistor 11 and the total pressure in the cuff can be measured using the pressure sensor 12. The pressure readings are analyzed by the compressor control module 5 and converted by the display control module 13 into a figure displayed on the indicator 15 by pressing the indicator backlight button 9. By pressing the start button (manual activation) 18, the haemostatic system is put into operation and begins to pump pressure to the specified parameters. By switching the ‘arm-leg’ toggle 16, which allows you to quickly change the minimum pressure from 250 mm Hg to 350 mm Hg, automatic operation mode is selected, depending on the placement of the device on the arm or leg.

[0075] The Figure 2 schematically shows the electrical connection of the modular control diagram of the haemostatic system.

[0076] The Figure 3 shows straps 20.

[0077] The Figure Figure 4 shows the possibility of using 4 haemostatic systems - two on the upper extremities and two on the lower extremities.

[0078] It is possible to use one or several of the claimed haemostatic systems simultaneously.

[0079] Automatic pressure inflation in the pneumatic cuff is possible up to 400 mm Hg (and can be changed in settings).

[0080] The cuff 19 has a pumping button 10, pressing which increases the pressure once in increments of 10 mm Hg. The pressure rise is controlled by the compressor control module 5 and thanks to the display module 13, the readings are displayed on the indicator 15 with the indicator backlight button 9.

[0081] An inflation resistor 11 is installed in the cuff 19, which slowly increases the pumping to the maximum values, which are controlled by the compressor control module 5.

[0082] The system includes a timer for fixing the operating time with a time / pressure indicator 15 on the display module 13.

[0083] In the system, the compressor control module 5 and the display module 13 can be manufactured on microcontrollers with the possibility of adding additional sensors, in particular temperature, saturation and pulse sensors.

[0084] The haemostatic system can be implemented as an element of clothing and made with an additional cuff protection element 19 of wear-resistant woven materials, such as Kevlar (aramid).

[0085] The haemostatic system is equipped with an arm-leg jumper, which allows you to quickly change the minimum pressure from 250 mm Hg to 350 mm Hg, respectively. It is possible to pump up the pressure to moderately increase the compression force.

[0086] The haemostatic system is designed with a closed air circuit and does not require additional power to maintain pressure.

[0087] The claimed haemostatic system works as follows.

[0088] The cuff 19 is worn on the upper limb of a person or placed in clothing. In this case, the clothing is provided with special ‘pockets’ with holster-like fastening, where the cuff 19 is installed. To the cuff 19, located on the upper surface of the limb, straps 20 are attached to the lower part of the limb through fasteners 3.

[0089] The system has three operating modes.

[0090] Automatic operating mode. In the case when the injured person is unconscious, with severe mechanical damage (including traumatic amputation of a limb), the system is triggered by a ’circuit break’ - the strap 20 opens or damages the conductive elements 17 and the control module 5 activates the compressor 4. At the same time, a timer is turned on, the operating time of which is regulated by the control module 5. Compressor 4 supplies air into pneumatic chamber 1 through air line 2, compressing the limb and stopping bleeding. The basic operating time is 30 seconds with the possibility of adjustment.

[0091] Manual mode. In the event of bleeding due to a wound or other injury, the injured person uses the buttons of the compressor control module with pressure control 5 to supply air to the pneumatic chamber 1. The injured person presses button 18 - the start button (manual activation); first the compressor 4 is turned on and then the timer is turned on, the operating time of which is regulated by the compressor control module 5. The compressor 4 is started, supplying air into the pneumatic chamber 1 through the air line 2, compressing the limb and stopping the bleeding. The basic operating time is 30 seconds with the possibility of adjustment.

[0092] Pumping. It is triggered and works when using the inflation resistor 11, which raises the minimum pressure when pressed or by pressing the button 10 - turning on the pumping, which directly turns on the compressor 4, with the possibility of manually selecting the optimal pressure.

[0093] Transmission and processing can occur using both analog and digital signals.

[0094] The proposed technical solution is industrially applicable, since it does not contain any structural elements or materials that cannot be reproduced at the current stage of technical development in industrial production conditions.

[0095] The claimed haemostatic system has elements or a group of elements similar to the elements of the above-described analogues, including the closest one, however: a set of functional capabilities, system design, its modularity and autonomy, the absence of branched air lines, wires, a refined automatic operating system (strap rupture, not just wire rupture), individual readings on the indicator when pressed, automatic pressure pumping system, hermetic closed air system, energy-efficient decentralized power supply, decentralized control, accurate pressure measurement in each element, small dimensions, low weight, universality of ’arm-leg’ application, fastening mechanisms, sensors for pressure, saturation, temperature and pulse; the system is used as an element of clothing with the possibility of installation in ready-made equipment, and is a separate device, while having the following advantages:

[0096] 1) Size:

[0097] - is an element of clothing, not a separate coverall with the possibility of ‘assembly’;

[0098] - all elements are arranged and hidden inside the cuff itself, without external elements (except for conductive elements and a special strap);

[0099] - general electrical circuit is divided into two circuits and located in different parts of the cuff, which allows for a more compact location inside the device itself;

[0100] - compact rechargeable batteries, compact location inside the cuff itself;

[0101] - layout and parts significantly reduce the overall weight of the product and expand its range of applications;

[0102] - all elements are modular and easily interchangeable.

[0103] 2) Functionality:

[0104] - automatic operating occurs due to damage to ‘conductive elements’ or loss of the ‘functional strap’ secured with special fasteners. The functional strap is attached with special fasteners in designated locations to create a controlled rupture site in the event of explosive traumatic amputation and while preserving the integrity of the conductive elements themselves. In this case, depending on the selected ’arm’ or ’leg’ mode, the required pressure will be automatically pumped with feedback from the pressure sensor;

[0105] - manual activation occurs after a single press of the corresponding button, while the pressure is also pumped up to the required parameters, followed by automatic maintenance of the minimum required pressure with the possibility of its display on the inflation indicator;

[0106] - the compressor itself is located inside the ’cuff device and has an individual power supply. In the event of a nipple failure, the compressor is the backup valve for the air system;

[0107] - pressure relief occurs only in manual mode, which allows to significantly increase the energy efficiency of the product (when the electric valve is operating, the battery charge is significantly consumed), to eliminate pressure loss in the event of a power outage, and to avoid uncontrolled ‘removal’. All other systems maintain pressure only in the on mode, as they have a pressure relief solenoid valve and, accordingly, release pressure from the system when the power is turned off; - the air system is closed and the operating pressure is maintained even if the system is deenergized. On the compressor side, the air line is closed with a nipple, on the other side with a mechanical valve;

[0108] - the pressure sensor is located between the air chambers in the cuff and measures the total pressure in the cuff, separately on each device, and not in the general system;

[0109] - the air system has no branched air lines extending from the central device, does not pass through body areas, does not create additional dead space, has no transitional fasteners, and is housed in a cuff, which reduces the depressurization of the system in the event of damage. The air system of the claimed device is connected via short air lines to the compressor via a nipple with two air chambers and a mechanical relief valve, and maintains pressure completely autonomously;

[0110] - the electrical conductive system, power supply and control system has no branches throughout the body, has no remote parts (except sensors), is autonomous, and is made for each cuff separately;

[0111] - all devices work independently of each other and are completely autonomous (when using 4 sets of ‘arm, arm, leg, leg’);

[0112] - the impact on the tissues is not caused by tourniquets, but by two wide chambers mounted in the cuff, which significantly reduces the traumatic mechanical effect;

[0113] - the claimed system includes a toggle switch located on a circuit board with an indicator that switches the ’arm-leg’ mode and automatically changes the pressure in the cuff from 250 mm Hg to 350 mm Hg;

[0114] - the possibility of individual equipment and installation into existing uniforms and is a separate element of the uniform;

[0115] - possibility of installing a module for nodal tamponade of the femoral artery / axillary space;

[0116] - possibility of programming for use as a monitoring device, in particular tracking pulse, pressure, temperature, saturation;

[0117] - the possibility of equipping with additional sensors, including remote monitoring means, which, in case of activation, sends a signal to the phone;

[0118] - the possibility of programming and individual settings of operating I tracking is limited by the user's needs;

[0119] - possibility of field modernization and configuration depending on requests.

[0120] 3) Components:

[0121] - the product is not a ‘holistic’ finished product in the form of a coverall with a long production cycle, but is the result of a component / modular assembly that is assembled for individual needs for both civilian and hazardous environments; - modularity and interchangeability of system components;

[0122] - possibility of field repair or repl cement.

[0123] - the possibility of improving the system.

[0124] 4) It is performed in two versions: It can be made in two versions: built into equipment and remote, as a separate means of individual and mutual aid for civilian use.

[0125] - lightweight - ‘built-in’ made in a separate lightweight version with an individual means of attachment and installation (mounting in ready-made ammunition) or on special attachment elements (even on a naked body). - full-fledged - ’separate tool’ as an individual separate means of self- and mutual assistance, made in the form of a cuff with a universal special fastener for ’locking’ to different diameters (made in appearance in the form of a cuff from a tonometer) with a universal fastening mechanism.

[0126] The claimed haemostatic system is autonomous, small-sized, convenient to use and provides the possibility of uniform distribution of pressure on soft tissues and vessels.

Claims

FORMULA OF INVENTION1. A haemostatic system comprising a compression element connected via an air line to a compressor, the compressor being connected via conductive elements to a control module, which is different in that the pneumatic chamber is used as the compression element, the compressor with power elements and the control module are mounted and secured in the cuff, the system additionally has a pressure sensor connected to the compressor and placed inside the pneumatic cuff, and a timer for fixing the activation time, the conductive elements are fixed via fasteners to straps secured to the lower limb.

2. The haemostatic system according to claim 1, which is different in that the control module is implemented on microcontrollers.

3. The haemostatic system according to claim 1, which is different in that it additionally contains temperature, saturation and pulse sensors.

4. The haemostatic system according to claim 1, which is different in that it is an element of clothing and is made with an additional protective element in the cuff made of durable fabrics.

5. The haemostatic system according to claim 1, which is different in that it is made with an ‘arm-leg’ jumper.

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