TECHNICAL FIELD

The invention relates to a system that prevents the formation of pressure sores, one of the most important problems of bedridden patients in the field of healthcare.

PRIOR ART

Pressure sores are a vital health problem especially for patients hospitalized in palliative and intensive care units. Taking precautions before the appearance of health problems is a key element of nursing care. Due to reasons such as the intensive working pace of nurses and patient intensity, some drawbacks are experienced in taking precautions in advance against the risks that may occur with the existing technical equipment in providing care to bedridden patients. The time and equipment are not sufficient for preventive applications such as detection of the patient's pressure areas, positioning of the patient for reducing pressure and massaging the affected area. The treatment of pressure sores that appear in certain parts of their bodies as a result of long-term exposure to pressure in bedridden patients can be quite costly and adversely affect the quality of life. The European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) defines pressure ulcer as "A pressure ulcer is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear." Pressure sore is a serious health problem that threatens bedridden patients all over the world and is difficult to treat when it comes to advanced levels. Pressure sores can occur anywhere in the body over a bony prominence, and most commonly, 95%, occur in the lower half of the body (65% pelvic area, 30% lower extremities) and 5% occipital and thoracic region. The location of the pressure sores is determined by the hospitalization position of the patient. Pressure sores are seen in the sacral (53.4%), heel (14.8%) and trochanter (12.5%) regions and rarely in the occipital region of the head, if the patient is lying on his back (Maklebust 1987, Young and Dobrzanski 1996, Oguz and Beger 1998). It is possible to examine the risk factors in the formation of pressure sores in two groups: internal and external factors. The most fundamental of the external factors is excessive pressure on the skin. The intensity and duration of this pressure are important. If the pressure of twice the end-capillary arterial pressure is applied to the skin for 30 minutes at two-hour intervals, the skin may show redness and hyperemia. And once the pressure is removed, it will recover in an hour. If the skin pressure is about twice as severe as the end capillary arterial pressure (70 mmHg) and lasts for two to six hours it causes ischemia, and if it lasts more than six hours, it causes ulceration of the skin (Legacy 1992, Demirel, Demiralp and Yormuk 2007; Ayumi et al 2013). If this pressure is removed intermittently, even the pressure of 240 mmHg reduces the effect on the skin and tissue. It’s determined that in the supine position, the sacrum, hip, heels, and occiput are pressurized to 40-60 mmHg, and in the prone position the knees and chest wall were pressurized to around 50 mmHg. Under these circumstances, the pressure on the skin is higher than the arterial pressure at the end of the capillary and continues continuously indicates the potential for creating pressure sores (Legacy 1992, Young & Dobrzanski 1996, Oguz & Beger, 1998). Friction occurs when vertical mechanical pressure is applied to the epidermis. In particular, raising the head of the bed by 20-30 degrees can create pressure sores in the epidermis in the area of the skin that is subjected to pressure. Inadequate drug treatment, disease or age of the patient due to the presence of immune suppression, irradiation, necrotic wound treatment deficiency, and infections can facilitate the effect of other external risk factors. Internal risk factors for the formation of pressure sores are associated to the wound development of the patient's mental and physical condition. In particular, the patient's nutritional status, hygiene conditions, body temperature, sensory loss, blood pressure, excessive drug use and age play an important role (Bergstrom & Braden 1989, Young 1997). The formation of pressure sores can increase the risk of mortality fourfold. It can extend the hospitalization period of the patient by at least 18-20 days. Serious bed sores can extend the average hospitalization period of patients by eight months, while superficial decubitus ulcers can extend by six months. Pressure wound prevalence and incidence rates are generally high in risky individuals such as those receiving palliative care, those with spinal cord injuries, neonates, and intensive care patients. According to the 2016 report of the European Pressure Ulcer Advisory Panel, worldwide Pressure Ulcer prevalence rates range from 41 % to 46% in acute care; 13.1 % to 45.5% in intensive care; 32.2% to 45% in aged care centers and 33.0% to 34.0% in pediatric care. According to the same report, the total annual cost of Pressure Wound Care in America is estimated to be close to $1 1 billion, and it is stated that an individual with pressure sores costs an average of $500-70,000 per year. In Europe, the cost of diseases associated with pressure ulcers was reported to account for 1 .4% of health expenditure in the Netherlands, ranging from $362 million to $2.8 billion per year. In Australia, this cost is 285 thousand AUD and in the UK it is 4% of the annual health budget ($750 million). By adding the total costs associated with pressure wound to hospital costs, this cost can reach £2.1 billion (www.epuap.org). Studies on the prevalence of pressure wounds in Turkey are limited, but according to the data obtained, the prevalence was 5.4-17.5% and the incidence was 54.8% in surgical patients (inan & Oztug 2012, Karadag & Gumugkaya 2006). In a meta-analytic study in which Mclnnes et al. (2015) examined 59 experimental studies on support surfaces in preventing pressure ulcers; they found that there are more studies indicating that the standard foam beds used in hospitals reduce the incidence of pressure ulcers, but the effect of surface mechanisms that can adjust the pressure constant and variable in reducing pressure ulcers is not clear in the literature. In addition, it has been stated that pressure-adjustable systems will be more effective than standard surfaces in UK studies. Special bed systems used to prevent the formation of pressure ulcers are completely separate units that are used instead of hospital beds. The treatment beds and the materials placed on the beds are pressure reducing, while special bed systems (low air closed bed sand liquefied air beds) are pressure relieving. Pressure reducing systems are divided into two as dynamic and static systems. In dynamic systems, an energy source is required to change pressure points, while in static systems, pressure dissipates over a wide area and no energy source is required. Vanderwee et al. showed that there was no difference between static and dynamic support surfaces in preventing pressure sores. In a randomized controlled study, Nixon et al. (2006) examined static and dynamic support surfaces as well as standard beds for the frequency of pressure sores development, and although there is no difference between static and dynamic support surfaces, they found that these surfaces significantly reduce the risk compared to standard beds. Although there is evidence that pressure sores can be prevented and treated with these support surfaces (Gul & Karadag 2015, Gill 2014), there is no conclusive evidence as to which support surfaces are more effective in preventing pressure wounds than others. Pressure ulcer formation poses adverse psychological, physical and financial challenges to patients and families. Edger (2017), in a study using a pre-test and post-test model using a system (Prevalon Turn and Position System; Sage Products LLC, Cary, Illinois) that positions intensive care patients and reduces pressure especially in the sacral region (with 717 patients), has found that the rate of pressure wound incidence decreases and the cost to hospital decreases. The cost of the 10-month pressure sore was 96000 dollars in the unit where the study was performed, and the total cost of the product was found to be 41000 dollars while the pressure sore was not seen in the first six months after the use of the pressure reducing system. Significant results were obtained in the experimental study in which Z Moore et al (2013) measured the runtime and cost- effectiveness of applications to prevent the pressure sores. According to the time spent by nurses per patient, the average cost was 206,6 Euros in the preventive care group and 253,1 Euros in the control group. Nursing professionals face a number of challenges in trying to provide holistic and individual-oriented services for the assessment and treatment of pressure sores. These challenges relate to the assessment methods, which treatments are used for pressure sores present in individuals, and which clinical decisions to make. The only way to completely eliminate all of these difficulties is to prevent injuries from occurring. Health professionals aim to significantly reduce pressure ulcer cases by using protective strategies such as identifying people at high risk and installing pressure reducing equipment. It is essential that interventions be based on the best possible clinical and cost- effectiveness evidence, and therefore, there are many studies in the literature on systematic review of the effectiveness of pressure-sensitive support surfaces such as beds, mattresses, pillows, and repositioning of these interventions (Tomova et al 2017, Mclnnes et al 2015, Stannard 2012, Baumgarten et al 2010, Mclnnes et al 2008). However, there are few studies reporting the experimental results and clinical responses of preventive methods in terms of efficacy and comfort, and most preventive systems for pressure ulcer risk do not meet basic requirements such as reliability, comfort and individuality. Yousef R. et al. (201 1 ) collected data from various sensors included in the proposed platform in the bed platform they developed for sore prevention and monitoring, analyzed these data and developed a pressure distribution map imaging method. This bed periodically adjusts the surface profile over the whole body to redistribute pressure by commanding the actuators of the bed. Pressure sensors are embedded under the air bladder and/or its body to provide force feedback to motor controllers. Each mobile surface moves at a maximum angle of 60.9, which should be sufficient to achieve the same effect as turning/mobilizing the patient. However, on the one hand, the other side of the moving surfaces that change the angle to reduce the pressure will increase the pressure in that area by applying extra pressure to the patient. At the same time, this bed works according to the principle of giving a position to the patient and is not suitable for the patients for whom the repositioning is objectionable. Since this bed also does not have the ability to massage and ventilate body tissues, it has no contribution to regulating the moisture content of the body parts under pressure and to regulating regional blood flow. Moving surfaces in the bed are fixed to the bed platform. In addition, in the event of any malfunction in a single piece, the bed may completely lose its function. Scott and Thurman (2014) stated that it is possible to position patients at a more appropriate time using the monitoring system of the pressure mapping method in bed wound prevention and improve the quality of life. With this system, the first bedside monitor device effective in reducing pressure, which provides feedback to nurses and caretakers, has been developed. Behrendt et al. (2014), in a prospective controlled experimental study conducted on 422 patients to investigate the effectiveness of this system, stated that monitoring by pressure mapping method was effective in preventing pressure sores. The pressure mapping and monitorization mentioned in this study is only one feature to be found in bed systems, and it has to be combined with other methods to prevent pressure sores. Seder R.M (2017) developed a 4-layered smart bedding prototype with multi-load sensing, which controls the base slope using a servo motor is a bed system that gives the patient a position without nurses having to change the position of the patients, especially during periods of long sleep. In this bed, the platform operates in a timed manner by means of various sensors integrated into the bed and allows to periodically adjust the surface profile to redistribute the pressure on the body according to the weighted distribution map of the body. This bed system works based on the principle of positioning the bed platform in the opposite direction of the perceived side where the body pressure increases by tilting at 30 and 60 degrees planar. However, changing positions alone is not enough to prevent the formation of pressure sores. On the other hand, this bed is not suitable for patients in which it is inconvenient to move by changing position. Sung CS. and Park J. (2017) have developed a sensor-based e-health imaging system in preventing pressure ulcers in their study. The sensor systems monitor patient's temperature, humidity and body position of the seating area in real time, and the information gathered from the sensors is displayed on the smartphone. Monitoring only temperature and humidity in this system alone is not sufficient to prevent the development of pressure sores. The pressure sore/bedsore prevention bed produced by BedAiD® Technology Research Center in Turkey consists of 45 removable cube blocks 13 cmx13 cm wide and 15 cm high with polyurethane coating. The cubes in the areas where pressure sores have formed or are likely to occur are removed by hand and the pressure leading to the wound is reduced to a minimum. As can be understood from here, the evaluation of the possibility of the formation of pressure sores in the patient using this bed should be done by the caregiver rather than by the bed producer. On the other hand, this bed is not suitable for use in patients who are inconvenient to move (www.bedaid.com). There is still no ideal and universal method for preventing pressure sores. On the other hand, avoidance of risk factors, preventive measures, support surfaces and new bed systems will provide the opportunity to use effective and economical approaches according to the patient's needs. The prevention of pressure sores, one of the most important health problems that can occur in bed-dependent patients, is a necessity within the framework of health policies and quality understanding of today. Existing beds are not suitable for patients where changing positions and moving is inconvenient. In addition, existing anti-pressure surfaces are usually directed at the pelvic area where pressure sores are common, yet the head area is not considered. Sores may also occur in occipital region of long-term inpatients. In addition, when any part of the existing patient beds used in the healthcare field is contaminated, the bed needs to be completely removed and new beds are needed.

As a result, the problems mentioned above and those that cannot be solved using the current technique, have necessitated innovation in the relevant technical field. BRIEF DESCRIPTION OF THE INVENTION

The invention relates to a smart bed system to eliminate the disadvantages mentioned above and bring new advantages to the relevant technical field.

The main purpose of the invention is to create a system that allows the prevention of pressure sores, especially in bedridden patients.

Another purpose of the invention is to develop a system capable of detecting the body regions subjected to pressure by mapping method.

Another purpose of the invention is to create a system that can reduce pressure regionally and/or automatically.

Another purpose of the invention is to establish a system that can adjust the humidity of the pressure zone with its local ventilation.

Another purpose of the invention is to provide a system capable of massaging to increase the blood supply in a pressure-affected region by its vibration.

Another purpose of the invention is to create a system with smart units that can operate independently of each other and a control unit that can manage these smart units.

Another purpose of the invention is to create a system that allows the prevention of head injuries that are neglected in the current technique.

Another purpose of the invention is to create a system that allows the mattress to be replaced and cleaned by means of smart units which are demountable when it comes to contact with body fluids of the patient such as blood and urine.

In order to fulfill all the purposes mentioned above and which will emerge from the detailed description below, the present invention is a smart bed system that prevents pressure sores occurring in bedridden patients. Accordingly, the system comprises; a smart honeycomb cell comprising follow,

• each of which can be controlled independently as individual cells,

o mattresses (2) that form the cell ceiling by being covered with a waterproof fabric having antibacterial properties and

o pressure sensors located under each cell mattress that measures the pressure of the patient's body in contact with the bed,

o a bellows that prevent damage to mechanical and/or electrical components when the patient's bed is wet or cells need to be cleaned, o an actuator that allows cells to move up and down under load,

o an upper support plate provided movement by the said actuator, o at least one local microcontroller that controls the said actuator

• a modular honeycomb group containing a plurality of said smart honeycomb cells,

• a cavity bed with gaps/spaces where the said modular honeycomb groups will be placed,

• a central computer including the database on which all the data coming from the smart honeycomb cell is collected and recorded, and which includes the analysis and interpretation algorithm that works on it and the bed control algorithm that provides the data to the user, obtains the pressure map and enables the end user to perform manual interventions,

• a global microcontroller that coordinates local microcontrollers within each smart honeycomb cell and is connected to the said central computer.

In order to be able to understand the advantages of the present invention together with the additional elements, it is necessary to evaluate it with the figures explained below.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a drawing of the smart honeycomb cell

Figure 2 is a perspective view of the smart honeycomb cell

Figure 3 is a top view of the smart honeycomb cell

Figure 4 shows the upper part of the smart honeycomb cell

Figure 5 shows the inner structure of the smart honeycomb cell

Figure 6 shows the drawing of the actuator.

Figure 7 shows a drawing of the upper support plate and the actuator.

Figure 8 shows the cavity bed from above.

Figure 9 shows a perspective view of the cavity bed.

Figure 10 is an image of different modular honeycomb groups mounted on the cavity bed. Figure 11 shows an image of an exemplary modular comb group.

Figure 12 gives a schematic view of the control components of the system.

REFERENCE NUMBERS 1 . Smart comb cell

2. Mattress

3. Pressure sensor

4. Vibrator

5. Bellows

6. Actuator

7. Upper support plate

8. Cavity bed

9. Modular comb group

9.1. Modular comb group for head

9.2. Modular comb group for body

9.3. Modular comb group for hip and thigh

9.4. Modular comb group for foot and leg

10. Local microcontroller

1 1. Global microcontroller

12. Central computer

YKA: Bed control algorithm

AAA: Analysis and interpretation algorithm

VT : Database

RT : Risk detection

V: Data

Y: Bed

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, improvement of the invention is explained only for a better understanding of the subject matter and without any restrictive effect. The invention is a smart bed system developed to prevent pressure sores in bedridden patients. The bed (Y) system developed within the scope of the invention will comprises independent a smart comb cells (1 ), each of which can be individually controlled, in the form of honeycomb. The smart comb cells (1 ) comprises mattresses (2) that form the cell ceiling by being covered with a waterproof fabric having antibacterial properties, pressure sensors (3) located under each the cell mattress (2) that measures the pressure of the patient's body in contact with the bed (Y), a bellows (5) that prevent damage to mechanical and/or electrical components when the patient's bed is wet or cells need to be cleaned, an actuator (6) that allows cells to move up and down under load, an upper support plate (7) provided movement by the said actuator (6), at least one local microcontroller (10) that controls the said actuator (7). The system also comprises a modular honeycomb group (9) containing a plurality of said smart comb cells (1 ), a cavity bed (8) with gaps/spaces where the said modular honeycomb groups (9) will be placed, a central computer (12) that obtains the pressure map by interpreting the data (V) received by the analysis and interpretation algorithm (AAA), comprising the database (VT) on which data from all smart comb cells (1 ) are collected and stored, and the bed control algorithm (YTA), which allows the end-user to perform manual interventions, and the global microcontroller (1 1 ) which coordinates the local microcontrollers (10) within each smart comb cell (1 ) and is connected to said central computer (12).

Each of the smart comb cells (1 ) is designed so that it can be easily attached to the modular honeycomb group (9) shown in Figure-10, removed and cleaned (or remounted) without damaging the mechanical/electronic internal structure of the smart comb cell (1 ) when needed. The bearing (Y) is modular in terms of ease of transport, replacement and maintenance. The drawing of the cavity bed (8) produced with spaces/gaps in which the modular honeycomb groups (9) mentioned in Figure-8 and Figure-9 will be placed is given. As shown in Figure 8, the non-movable sponge part of the bed (Y) is designed as a whole, and the movable modular honeycomb groups (9), as seen in Figure 10, are located in the cavity bed (8) in the forms of modular honeycomb group for the head (9.1 ), the modular honeycomb group for the body (9.2), the modular honeycomb group for hip and thigh (9.3), and the modular honeycomb group for leg and foot (9.4). In the preferred embodiment of the system, the aforesaid areas will be ventilated via the capillary tubes that will be placed between the smart honeycomb cells (1 ) in order to prevent the acceleration of ulcer formation due to moisture in the parts of the patient that contact with the bed (Y). In order to prevent this process from affecting patient comfort, DC motor fan will be used due to its silent operation and the air received from the environment by means of this fan will be distributed to each smart comb cell (1 ) from inside the bed (Y) by being sprayed to the top of the bed (Y). In this way, the comfort of the patient will be provided at the highest possible level and perspiration can be prevented. The mattress (2) that forms the cell ceiling of smart comb cells (1 ) will be designed in a soft structure in the form of cork. At the bottom of this mattress (2) to be made of sponge, a pressure sensor (3) to measure the pressure of the patient's body in contact with the bed (Y) and a vibrator (4) to provide blood circulation via massage in order to prevent wound formation in the patient's body will be placed. The vibrator (4) will not be used in the smart comb cells (1 ) within the modular honeycomb group for the head (9.1 ) since vibration may cause harm to patients with head trauma, and will not be used in the smart comb cells (1 ) within the modular honeycomb group for the leg and foot (9.4) because the soft tissue layer is thin and there is no need for vibration massage. In cases where the patient's bed (Y) is wet or smart comb cells (1 ) need to be cleaned, the bellows (5) will be placed between the honeycomb and the mattress (2) in order to avoid damage to mechanical and/or electrical components. Thus, the bellows (5) will be opened during the upward movement provided by the actuator (6), and similarly, the bellows (5) will be folded during the downward movement, preventing the liquid from entering the smart comb cell (1 ). Within each smart comb cell (1 ), a linear actuator (6) will be used, enabling the upward and downward movement of the mattress (2) section where the comb is in contact with the body. Among these actuators (6), which are available in various types on the market, a type with a 5 cm stroke and a torque of 20 Nm, driven by a DC motor and a current of 12 volts / 5 amperes, will be preferred to keep the dimensions of the smart comb cell (1 ) small. The base of smart honeycomb cells (1 ) will have a sheet metal base where actuators (6) can take action. The upper ceiling mounted on the actuator (6) will also consist of the upper support plate (7). Pressure sensors (3) will detect the pressures of the body's contact points on the bed, and this pressure information will also be stored in a database (VT) located in the central computer (12) to perform instantaneous pressure mapping. Accordingly, at the high-pressure points, the corresponding smart comb cells (1 ) will be pulled down and the pressure will be lowered. Each smart honeycomb cell (1 ) will be able to move its in-house actuator (6) upward and downward independently of other smart comb cells (1 ) depending on the pressure value it measures. For this purpose, a local microcontroller (10) (Arduino Nano) and the DC motor drive circuit will be used within each smart comb cell (1 ). In addition, a global microcontroller (1 1 ) (Arduino Uno) connected to the central computer (12), in which the pressure data of each smart comb cell (1 ) is collected on and the pressure map is obtained, will be utilized. The local microcontrollers (10) and global microcontroller (1 1 ) will communicate with each other over the I2C (TWI) protocol. The said central computer (12) will be selected as an integrated (all-in-one) computer with a touch screen. With the bed control algorithm (YTA), manual control of each smart comb cell (1 ) will be provided via the touch screen. Here, the priority will be given to manual control, and if there is no external interference, the smart comb cells (1 ) will operate in automatic/independent mode by controlling the pressure and actuator (6) themselves. In automatic mode, each smart comb cell (1 ) will evaluate the pressure measurement and, if necessary, try to pull the mattress (2) down for two hours and thereby reduce the pressure in the contact zone. At the end of this period, the mattress (2) will be driven up in order to support the body weight again.

The features of the hardware components and algorithms of the invention that will be used to control each hardware are listed below.

Integrated central computer with touch screen (12): It is the computer that will allow the end- user to interact with the bed (Y), that will store the pressure data from smart comb cells (1 ) in the database (VT) and analyze this data via an analysis and interpretation algorithm (AAA). It will run on a Windows operating system. The end-user will be able to control smart comb cells (1 ) via the touch screen through the global microcontroller (1 1 ) connected to the central computer (12). The bed control algorithm (SCA), which is at the disposal of the end user and will be controlled via the touch screen, and generated using the C # programming language and the IDE named Visual Studio.

Global microcontroller (1 1 ): It will be connected to the central computer (12) via USB port. On the other hand, the local microcontroller (10) of each smart comb cell (1 ) will be in communication with the global microcontroller (1 1 ). The Global microcontroller (1 1 ) will be selected as Arduino Uno and programmed with AVR C.

Local microcontroller (10): It will be located inside the smart comb cells (1 ) and will digitalize the analog input data received from the pressure sensor (3) and control the position of the actuator via the DC drive. As a local microcontroller (10), the Arduino Nano, which is smaller in size than the Uno model, will be used due to the limited space within the smart comb cell (1 ) and it will be programmed with AVR C.

On the other hand, there are 4 sub-functions of the smart bed (Y) system that concern the algorithm: Collection and storage of pressure data (V): The pressure data (V) from each smart comb cell (1 ) will be combined with a metadata (date and time) and stored in a database (VT).

Visualizing instantaneous pressure data (V) as a map: The pressure data (1 ) from each smart honeycomb cell (V) will be stored in the database (VT) while simultaneously visualizing it as a pressure map and projected onto the touch screen. Different colors will be used for different ranges of values, allowing the end-user to manually intervene in smart comb cells (1 ) with risk detection (RT) when needed. Analyzing and understanding the pressure data (V): The main purpose of the bed (Y) which is planned to be developed is to prevent the occurrence of pressure ulcers. On the other hand, if such ulcers develop, the pressure data (V) and actuator (6) movements recorded by the smart comb cells (1 ) in the ulcer region should be analyzed retrospectively and should be understood with machine learning algorithms. The outputs of these algorithms are generally in the form of a list of rules and these rules will be used to improve the control behavior of the bed system in the form of feedback.

The control of the actuator (6) inside the smart comb cells (1 ): The linear actuator (6) in each smart comb cell (1 ) will be moved upward or downward by means of the respective local microcontroller (10) which processes the pressure data (V) in automatic or manual mode.

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