PRESSURE ULCER CARE, TREATMENT AND PREVENTION DEVICE
A non-invasive pulsed electric field therapy device addresses the limitations of current pressure ulcer treatments by applying a pulsed magnetic field to bedridden patients, enhancing wound healing and prevention while reducing healthcare costs and patient discomfort.
Patent Information
- Application Number
- TR202402619
- Authority / Receiving Office
- TR · TR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2024-03-05
- Publication Date
- 2026-10-21
- Estimated Expiration
- 2044-03-05
AI Technical Summary
Current methods for preventing and treating pressure ulcers in bedridden patients are limited, financially burdensome, and often require invasive procedures, leading to prolonged hospital stays and increased healthcare costs.
A non-invasive pulsed electric field therapy device that applies a homogeneous pulsed magnetic field to the affected area using a flexible, metal-coated mattress and control unit, allowing for preventive and therapeutic treatment without direct contact with the patient.
The device accelerates wound healing, prevents pressure ulcers, and reduces the risk of infection and tissue damage, providing a cost-effective and safe treatment option that does not require patient movement.
Smart Images

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Abstract
Description
1 TARIFF PRESSURE ULCER CARE, TREATMENT AND PREVENTION DEVICE Technical Area For hospitalized patients, the bedside table can be used fixed or separately; for patients with pressure sores, either 5 For use in bedridden patients who are suitable for this, the patient's movement for dressing or treatment. by eliminating the need for manual intervention, without touching the patient and without causing a rise in temperature Pulsed magnetic resonance imaging (PMR), which interacts only with the target wound tissue, can be routinely applied. It is a device for the care and prevention of pressure ulcers in the field. State of the Art Pressure ulcers are referred to by many terms in the literature and in everyday use, such as pressure ulcer, bedsore, and decubitus ulcer. Pressure ulcers are present. They are generally caused by persistent pressure on the skin and underlying bone prominences. It occurs when damage to the underlying tissue disrupts blood flow. The body... Due to this prolonged pressure applied to a specific area, the capillaries and lymphatic vessels rupture over a long period of 15 days. temporary closure, ischemia, reperfusion, and tissue deformation (cuts, friction, abrasions, etc.) It results from injury to the affected tissue through a combination of mechanisms. Friction of the skin against a material such as clothing or bedding can cause a break in the epidermis. It causes friction, and repeated friction can lead to deeper injuries. Cutting, Friction and abrasive forces correspond to two surfaces moving in opposite directions. This situation is described in point 20. For example, raising the head of the bed, during patient care or spontaneously. This is the condition where the patient can slide out of bed. This strong interstitial plane movement causes blood flow. This causes the blood vessels to rupture, which reduces blood flow and can even lead to necrosis in that tissue. This will cause bone to form. If this injury is not treated early, it is impossible to cure, and bone will form inside. and full-thickness tissue damage can develop, including muscle tissue. The external pressure is higher than the pressure in the capillary bed. Continued pressure will reduce blood flow to the underlying tissue. This will cause a decrease in blood flow within the tissue. This will lead to hypoxia and eventually necrosis. The pressure required for the formation of a pressure ulcer (pressure sore). The amount or duration will vary depending on tissue quality and blood flow. For example, peripheral vessels In patients with underlying conditions, i.e., those whose blood circulation is already impaired, pressure ulcers can develop. Lower overall pressure or a shorter duration is sufficient. 30 Pressure ulcers can occur in any long-term bedridden patient, but are more common in those with certain risk factors. It is seen more frequently. Those who have lost their mobility due to their existing illness or during the treatment process 2 This applies to patient groups who need to remain immobile for extended periods, and especially to frail elderly individuals. It is quite common in the patient population. Hospitalized patients over 75 years of age with pressure ulcers. Patients with pressure ulcers spend an average of 10 days longer in the hospital than those without pressure ulcers. This has been detected. In addition, malnutrition (nutritional disorder, improper nutrition), Exposure to excessive moisture, carelessness in patient positioning, and friction resulting from excessive movement in bed. 5 Absence or low level of consciousness are also other risk factors. These factors are observed, and considering these factors, intensive care units and palliative care centers A large proportion of hospitalized patients appear to be at risk. Risk of pressure ulcers (pressure sores). Patients carrying these conditions are already struggling with pre-existing health issues, and if precautions are not taken, further problems may arise. He will also have to deal with pressure sores. 10 Today, high-risk patients, as well as those routinely requiring intensive care unit and palliative care, In these centers, patients are assessed for the development of pressure ulcers using a number of currently recommended scales. This is checked and noted. In addition, within the scope of nursing care guidelines, movement is monitored. daily reports for patients who are unable to cooperate, are sedated and monitored on a ventilator, or are unconscious. Position changes and repositioning operations are performed at the suggested time intervals. This is 15 In addition, air pressure beds and dehumidification processes can be applied to the extent possible. Providing nutritional support to patients, combating anemia and infection, relieving pain, and enabling mobility. Health care, treatment of acute and chronic diseases, and other preventive measures are among those applied. However, Despite precautions, pressure ulcers can develop, and this can be complicated, affecting the patient. This can become a challenging situation for relatives and healthcare practitioners. In addition to the measures taken in clinical practice, 20 There are limited options available as treatment for pressure ulcers that develop as a result. These options include: However, difficulties are encountered in achieving this. The most significant of these difficulties is financial inability. This can be demonstrated. Furthermore, the described current situation highlights issues such as hospital stay durations and treatment costs. It appears as follows. According to the National Pressure Ulcer Advisory Panel, 25 is defined as a condition that should never occur. Pressure ulcers have significant physical, psychological, and financial impacts on patients and healthcare systems. It also causes very severe pain and negatively affects the quality of life of patients. Combined The kingdom's National Health System (NHS) reported the cost of treating patients diagnosed with pressure ulcers between 2015 and 2016. They stated that it is approximately 3.8 million pounds. A study conducted in our country revealed that annually in Türkiye... On average, 308,796 patients may develop pressure ulcers, and the cost of this could be approximately 1 billion 425 million 30 thousand. It is estimated to be in dollars. The previous article, document number TR2023 / 008451, describes a care arrangement for bedridden patients. It is described. It is intended for use in hospitals, nursing homes, care facilities, or homes, and for the elderly. Lying immobile for extended periods due to various reasons such as chronic illnesses or previous surgeries 3 designed to facilitate the care of bedridden patients who have to endure pressure sores (pressure ulcers). to prevent its formation, to make bed linens easy to change, and to protect the patient to make it easy for the patient to be transferred to the washing kit or wheelchair allowing it to be easily lifted from the bed, thus saving both time and manpower. providing, easily mountable onto existing hospital beds and stored in the next 5 when not needed The present invention relates to a maintenance device that can be easily disassembled and removed for use. It is a device and has no effect on healing or preventing pressure sores. According to document TR2020 / 20709, which describes the known state of the art, it is used in the medical field. To prevent the formation of pressure ulcers (pressure sores) in patients who remain in a lying position for a long time. The stimulus is created by controlling the conditions under which the wounds in question form, and 10 on the patient's body. The text describes a bed that allows for the early identification of areas at risk of developing pressure ulcers. A mattress containing sensor cards that have a pressure, temperature, humidity, and wetness sensing system, By collecting data from the main mattress and determining the rates, we can identify whether pressure ulcers may develop. It is a device that enables the detection of risky areas. It uses a pulsed magnetic field to apply pressure. It does not have a mechanism that enables the healing or prevention of its wound. 15 In the current technique, document number EP1741467A1 shows inadequate blood perfusion, partial For the treatment of lesions associated with denervation, tissue loss, pain, edema, burning, and infection. An electromagnetic device is described. It uses a Helmholtz coil to generate a uniform magnetic field. It is a device. It contains a pair of coils, a base, and an independent rail for movement. The coils travel along the entire length of the rail. 20 mounted on a sliding base that moves along its horizontal surfaces or flanges, not shown It has been constructed. Following the base, a central point is located in the center of the upper flat longitudinal surface. A longitudinal guide slot is located. At the opposite end of this surface are the coils bounded by the surface. A distal stop is included to prevent it from sliding outside the area, and the surfaces and flanges are fitted with... Helmholtz coils, which produce low-frequency magnetic field lines, support the movement of the car. It is part of the longitudinal rail-type sliding base. According to the relevant document, the patient coil device contains 25 He is lying down. A magnetic field passes through the entire body. However, in the device that is the subject of the invention... There is no magnetic field; an electric field is used. (This is consistent with document EP1741467A1) This is one of the most important differences. Furthermore, the device in question uses only an electric field for treatment. It is the first and pioneering invention in terms of its use. Thanks to the device that is the subject of the invention... The doctor performing the treatment will apply the high-voltage electric field mat only to the area where the pressure ulcer is located. It can be redirected. Therefore, it has different characteristics than the EP1741467A1 document. Electrical stimulation monitoring editor for the treatment of pressure ulcers encountered in the previous technique, "Electrical stimulation for treating pressure ulcers monitoring editor, Mohit Arora, Lisa A Harvey,corresponding author Joanne V Glinsky, Lianne Nier, Lucija Lavrecic, Annette Kifley, Ian D 4 Cameron, and Cochrane Wounds Group" (doi:10.1002 / 14651858.CD012196.pub2 (https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC6984413 / ) research on healing pressure ulcers This describes a treatment method that involves attaching small electrodes near the wound area. Here, researchers are attempting to heal the body using a technology known as an invasive electrode method. They looked. 5 The current technique involves electrical stimulation in combating pressure ulcers in immobilized individuals. "Electrical stimulation" uses remotely controlled methods that shape the same known technology. Stimulation in Combating Pressure Ulcer for Immobilized Subjects: A Conceptual Framework, Amelia Wong Azman, Fawwaz Eniola Fajingbesi, Zuraida Ahmad, Yasir Mohd Mustafah, Rashidah Funke Olanrewaju and Nur Azah Hamzaid (doi:10.1088 / 1742-6596 / 1372 / 1 / 012056) 10 (https: / / iopscience.iop.org / article / 10.1088 / 1742-6596 / 1372 / 1 / 012056 / pdf) This article A new pressure ulcer treatment that can be used for both wheelchair-bound and bedridden patients. It presents the concept development and implementation process of the system. The concept here is electrical. the use of stimulation, interface pressure mapping, and redistribution with antimicrobial protection The goal is to integrate it not only as a treatment but also as a means of preventing pneumonia. 15 The effectiveness of magnetic field therapy in pressure ulcers in bedridden patients encountered with the previous technique, "Efficiency of Magnetic Field Treatment on Pressure Sores in Bedridden Patients, Ferda Özdemir, Meliha Kasapoğlu, Figen Oymak, Sadiye Murat" (DOI: 10.5174 / tutfd.2010.03601.2), (https: / / dergipark.org.tr / en / download / article-file / 42881) a system using a pulsed magnetic field In the study, 20 wounds were focused using an inductive applicator directed at the wound area. This is a study that observed a fairly rapid recovery. The magnetic field... Difficulty focusing, heating problems due to current passing through the system, fire risk, inefficiency. Disadvantages such as those related to research limit the routine use of such methods. According to document US11278237B2, which is seen in the known state of the art, pressure-related ischemia is defined as: Devices for preventing, detecting and treating pressure ulcers and other conditions, 25 Systems and methods are described. Pressure ulcers, pressure-related ischemia, and related medical conditions. It is a system for monitoring medical conditions, including location, orientation, and temperature. Detects one or more patient characteristics including acceleration, humidity, resistance, stress, and heart rate. It includes sensors adapted to monitor blood flow and heart rate in hospitalized patients. Parameters such as humidity level are monitored using a sensor. Therefore, wound treatment is 30... It has no relation to that. Currently in clinical practice, alginate dressings, polyurethane films, hydrogel dressings, and hydrocolloid dressings are used. The coverings and foams can contain hyaluronic acid, collagen, elastin, alginates, and chitosan all together. Bioactive dressing materials, for example, can be used in contact with the patient, by positioning them, and by keeping the wound moist. Products that hold are available. In addition, negative pressure wound healing devices and ultrasound applications are available. Techniques such as these can also be used. In particular, the use of ultrasound in pressure ulcers. It was found to have no difference when compared to placebo. This type of modern wound care and dressing... Unfortunately, although the effects of these materials have been clinically proven, they are financially burdensome for both the hospital and the patient. Because it puts a great strain on their families, patients are often treated conventionally. In the current state of the art, and as described above, the patient can be integrated into the hospital bed. with the preference for a fixed or portable bed, especially one made of plastic or wood. The desired pulsed magnetic field frequency will prevent the formation of pressure sores or The lack of research and development work in this area regarding the healing of pressure ulcers that occur is a problem. This has made it necessary to do so. Purpose of the Invention The purpose of the invention is to provide treatment for pressure ulcers, a type of ulcer that has been clinically proven to scale, and for pressure ulcers. Device 15 provides a pulsed electric field therapy method that can be routinely applied to patients at high risk. It is the process of obtaining it. The purpose of the invention is to provide a device that attaches to a patient bed made of plastic (PVC) or wood. Thanks to the pulsed magnetic field, it enables wound treatment without moving the patient, or for bedridden patients. The goal is to provide devices that prevent pressure ulcers in patients. The aim of the invention is to create a device that can be easily applied to the desired surface on the body of a bedridden patient, 20 The practitioner / physician should place a mattress-like cover over the area at risk of developing pressure sores or where pressure sores have already developed. The goal is to obtain a device that will provide treatment by positioning it. The purpose of the invention is to create a power supply and control unit that can be used portably as well as in routine applications. on the bedside table for patients who may potentially develop or have already developed pressure sores It is also used in a fixed position. 25 The aim of this invention is to treat, without contact with the patient (non-invasively), the possibility of developing pressure ulcers and / or It can be used both preventively and therapeutically in patients who have developed pressure ulcers, directly affecting the patient. This device has the advantage of not making contact with the wound, thus preventing the wound from becoming moist. It is done. The aim of the invention is that practitioners do not have to move the patient during the procedure. 30 thanks to this, abrasions, tears, and other injuries that may occur to the wound during movement can also be prevented. The advantage is obtaining a device that can prevent this. 6 The aim of the invention is to create a non-invasive device with three basic components that can be used without contact with the patient, and that increases heat output. non-invasive, does not interact with tissue other than the target tissue, and therefore does not produce side effects. The goal is to obtain a device that does not cause damage and provides a safe, efficient routine application. The aim of the invention is to convert an applied external pulsed electric field into rotational electric currents within tissue. (induced circular electric currents) cause an effect that shortens the treatment process. 5 is to ensure. The aim of the invention is to utilize the flexible structure of PVC, a basic insulation material, for the moving part of the system. it has a flexible cover and a metallic coating embedded within this cover that is invisible from the outside and does not touch the patient. This involves applying a pulsed electric field to the pressure ulcer area of the patient using an electrode. The invention concerns a device for the care / treatment and prevention of pressure ulcers, 10 - A bed frame made of wood or PVC, - A fixed plate that fits the dimensions of the case, - A waterproof underlayment covering the fixed plate, - A mattress to be placed over the patient's wounds, - A control unit that provides pulsed electric field control, 15 - Adjustment knobs that allow for setting the pulsed magnetic field frequency. - A plug that supplies electricity to the system, - Transmission of the pulsed magnetic field from the control unit to the fixed plate and top mat. connecting cables, - Ground wire 20, connected to the fixed plate, which allows electrical energy to be directly transmitted to the ground. includes the line. Explanation of Invention Methods Figure 1 - Wooden / Plastic Patient Bed Frame View Figure – 2 View of a Patient Bed Frame with Fixed Plate Positioning 25 Figure 3 - Top and Bottom Mattresses Interconnected and Connected to the Control Unit Figure 4 - Lateral Cross-Section View of the Top Mattress Figure 5 - Pulse Shape and Application Time Graph of Current from the Control Unit Figure 6 - Circuit view that converts the current from the mains into pulsed signals in the control unit. 7 Part Reference Numbers: 1. Bed Frame 2. Fixed Plate 3. Bottom Mattress 4. Top Mattress 5 4.1. Metal Electrode 4.2. Fireproof Foil 5. Connection Cables 6. Control Unit 6.1. Adjustment Knobs 10 6.2. Receipt 6.3. Screen 7. Grounding Cable Detailed Description of the Invention 15 The invention concerns a device for the care, treatment, and prevention of pressure ulcers, based on the bed frame detailed in Figure 1. (1) Fixed plate positioned on the carrier slats (2), its positioned view as shown in Figure – 2. It consists of a bottom mat (3) positioned on the given fixed plate (2). The bottom mat (3) consists of any It does not contain a metal element. It includes an active top mattress (4) that is placed on the patient. Bed The frame (1) is preferably made of wood or PVC plastic. The supporting slats are preferably made of the same material. Made of wood or PVC plastic, without any metal in its joints or fastening parts. No part is used. The fixed plate (2) is positioned on the carrier slats and into the bed frame. (1) is also connected. The patient is placed on the bottom mattress (3) which is positioned on the fixed plate (2). He is lying down. An active top mattress (4) is placed over the patient. The top mattress (4) is active, meaning it is metallic or It contains a metal electrode (4.1) made of aluminum alloy. Bottom mat (3) and top mat (4) water 25 It is of a non-permeable structure. The top mat (4) preferably protects the metal electrode (4.1) and provides flexibility. Made of PVC material. Top mat (4) and fixed plate (2) are parallel to each other. It is positioned so that the procedure can be performed on the patient lying on the bottom mattress (3). The fixed plate (2) and the top mat (4) will be connected to the control unit (6) via connection cables (5). It draws power. Also, preventing electrical leakage and ensuring that electrical energy is transmitted directly to the ground is crucial. 30 8 To ensure this, a conductive grounding cable (7) is connected to the fixed plate (2). Control unit (6) It includes adjustment knobs (6.1) that allow adjustment of the frequency and power of the pulsed magnetic field. Thus, the frequency can be adjusted via the adjustment knobs (6.1) on the control unit (6) by the operator / user. It can be done by controlling it from the screen (6.3). The connection that enables the control unit (6) to receive power. It is used to receive current by connecting the cable (5) to its end and inserting both ends into a socket that matches it. It includes a plug (6.2) that supplies power to the control unit (6). Metal inside the top mattress (4) non-flammable foil protecting the electrode (4.1) and providing protection in case of any fire or similar situation. (4.2) is included. (Figure – 3) The pressure ulcer care, treatment, and prevention device is designed as a bedside device for hospitalized patients. The three main parts of the device are the bed frame (1), the fixed plate (2) and the active top mattress (4), the power supply and control unit 10 (6) is. According to basic electromagnetic principles, a parallel plate applicator has a fixed plate between the plates. It is the only method for creating an electric field. The fundamental starting point of this invention is wound healing. generally accelerating recovery parameters, specifically in patients who have been bedridden for a long time. The goal is to create a method that accelerates healing in pressure ulcers. Actually, as described in the previous technique... This device, which helps solve problems, is suitable for all bedridden patients, especially those at risk of developing pressure sores (15). It is intended to be used as a routine treatment device. The outcome of this invention will be both social and financial. This will offer many advantages, including creating a treatment method that is not currently available anywhere in the world. Pressure ulcers are clinically proven to scale and develop in long-term bedridden and bedridden patients. Pulsed electrical stimulation can be routinely applied in wounds of this type and in patients at risk of pressure ulcers. Pressure ulcer prevention device providing field, control unit providing electric field supply and control 20 (6), fixed plate (2) with reference electrode, providing a homogeneous pulsed electric field with fixed plate (2) It contains a metal electrode (4.1) which is the active electrode. It is mounted on the support slats of the bed frame (1). It includes the aforementioned fixed plate (2) positioned parallel to each other. The metal allows the resulting homogeneous pulsed electric field to act on the wound tissue of the patient. It includes an electrode (4.1) and a fixed plate (2). The metal electrode (4.1) must be in contact with the patient's body for 25 minutes. It includes an active top mattress (4) which prevents the bed frame (1) from being made of wood or PVC. It is made of plastic. It is positioned on the fixed plate (2) mentioned above, on which the patient is lying. It includes a lower mattress (3). The upper mattress (4) is placed on the patient, the cross-section view of which is given in Figure 4. It includes. The bottom mattress (3) and the top mattress (4) are made of waterproof material. Metal electrode (4.1) top mattress (4) made of flexible PVC material which protects and ensures the flexible structure of the cover 30 The metal electrodes (4.1) inside the top mat (4) and the fixed plate (2) are connected to the control unit. (6) includes connecting cables (5) that provide the connection. Prevention of electrical leakage, electrical To ensure that the energy is transmitted directly to the ground, a conductive grounding connected to the fixed plate (2) It includes cable (7). The frequency and power adjustment of the pulsed electric field from the control unit (6) 9 It includes adjustment knobs (6.1) that enable it to be made. It provides power to the control unit (6). By connecting the connection cable (5) to the end and inserting both ends into a suitable socket, the current can be obtained. It has a plug (6.2) that provides the frequency and power of the pulsed electric field from the control unit (6). It includes a screen (6.3) that controls the setting. Inside the fixed plate (2) and the top mattress (4) Socket connections that enable the metal electrodes (4.1) to be connected to the connecting cables (5) 5 It includes the top mattress (4) which is an active patient cover, providing flexibility, fireproof properties and waterproof structure. It contains non-flammable foil (4.2). It receives 220V from the mains via the mains connected cable (5) and plug (6.2). By controlling the effective value sinusoidal supply voltage V through a slicer / chopper circuit, high voltage can be achieved. applying high voltage to the primary of the transformer and providing pulsed high voltage supply via a rectifier circuit. It includes a control unit (6). The electrical current to be applied to the patient is between the fixed plate (2) and the electrode (4.1). The mentioned control unit (6) ensures that the field value range is between 0 kV / m and 10 kV / m. is happening. The device described in this invention allows for the treatment of target tissue without touching the patient (non-invasive), and without increasing heat. A type of care that provides a safe, efficient routine application without interacting with other tissues, A treatment and prevention method has been obtained. Our preliminary studies have shown that the target tissue is 15 This indicates that there will be no undesirable side effects in tissues other than those in the invention. the influence of magnetic, ferromagnetic, and metallic objects present in the environment on the homogeneity of the electric field In order to prevent this, care has been taken to ensure that the patient bed frame (1) is completely free of metal. In electromagnetic theory, Maxwell's equations apply to ambient parameters at sufficiently high frequencies. Based on the applied magnetic field, the magnetic field in the tissue, the applied electric field, the magnetic field 20 This can be the reason. According to the basic principles, the external impact method we applied in our study... The electric field causes induced circular electric currents within the tissue. (IIIE C95) and these currents shorten the treatment process. The movable part of the system is flexible. The top mattress (4) has a flexible cover structure and the outside is embedded in this top mattress (4). It is an invisible metallic electrode that does not touch the patient (4.1). This electrode (4.1) is suitable for all scenarios 25 The appropriately sized device will be manufactured and applied by the practitioner to the patient's pressure ulcer area. It will be positioned as follows. The socket of this electrode (4.1) and the socket connections and connecting cables (5) It will be flexible enough to be applied only to the area where the pressure sore is located, if desired. It will be available for use. Pressure ulcer care device for non-invasive treatment of pressure ulcers that are likely to develop and / or have already developed pressure ulcers. It can be used both preventively and therapeutically in advanced cases. Directly to the patient's wound. The fact that there is no contact also has the advantage of preventing the wound from becoming moist. In addition, the practitioners The fact that the patient does not need to be moved during the procedure also prevents damage to the wound that occurs during movement. Another advantage is that it prevents potential injuries such as scrapes, tears, and abrasions. It has all these features. As a result of all these characteristics, pressure ulcer treatment contributes to the country's economy, workforce, patients, and Considering the negative impact on their loved ones, it will yield extraordinary benefits. A bed frame, preferably made of wood or PVC, is one of the main components of a pressure ulcer care, treatment, and prevention device. (1) contains a stationary plate (2) with a fixed 1 mm thick CrNi plate inside. This plate (2) is complete The size can vary depending on the inner dimensions of the bed to be used. 5 for the plate (2). The given dimensions may vary in the preferred applications of the invention; limiting effect. It does not form. This is permanently connected to the operating ground of the network by the grounding cable (7). The fixed plate (2) will act as the reference electrode. As is known, the electric field vector is active. It creates a homogeneous electric field from this electrode to this reference electrode. Here, the active electrode is the upper one. The metal electrode (4.1) is located inside the mattress (4), and the reference electrode is the fixed plate (2). Active patient 10 The top mattress (4) with cover contains flexible, fireproof, waterproof aluminum fireproof foil (4.2) In other words, there is metal foil. Flame-retardant foil (4.2) is applied to the active output terminal of the control unit (6) for HV insulation. It is connected in accordance with the rules. 220 V effective sine wave from the mains. In the feed control unit (6), the grains will first be subjected to the chopping process detailed in Figure 2. The electronic circuit here allows for output within the desired setting range by connecting a dimmer to the transformer primary. It applies pulsed signals. High voltage is applied depending on the amplitude and frequency of the pulsed signals. The transformer provides power supply to deliver a maximum active output of 4.5 kV. Therefore, it provides high voltage. The supply voltage, which is sliced in the primary of the transformer, is obtained at the transformer output and is half-wave. It will give a rectified output. In fact, this output is a pulsed signal waveform derived from a sine wave. Although the fixed plate (2) and the grounding cable (7) are fixed in place inside the patient bed, active 20 The position of the top mattress (4) which is the cover on the patient will vary within certain limits. The World Health Organization's limit value for the ELF frequency region and electric field is 10 kV / m. (WHO, ELF Exposure Electric Field Limit) has been determined. Therefore, when designing, the patient's exposure Care will be taken to ensure that the electric field value for therapeutic purposes does not exceed this value for this patient. The calculation results for the highest electric field to be applied have been carefully considered. The lowest electric field is 25. Biologically accelerated improvements obtained from our preliminary study on area value The parameters indicate that tissue interaction is not at a sufficient level below 1 kV / m. If a calculation is made regarding this, taking the maximum distance between the two coverings as 0.45 m and below Since the limit is 1 kV / m, the minimum voltage that can be applied is 450 V. Therefore, the control unit... The system should be able to adjust the effective 220V sine wave of the grid between 0.45 kV and 4.5 kV. Thus, at least 30 The lowest voltage range will be 1 kV / m and the highest voltage range will be 10 kV / m. (Figure – 5) The supply and control unit (6) can preferably be used in a portable manner or preferably in routine application. on the bedside table for patients who may potentially develop or have already developed pressure sores It can be used in a fixed position. Both the electronic connections and the other components are suitable for all usage conditions. 11 The connections of the cables (5) connecting the electrode to the power supply and control unit (6) are in accordance with international medical standards. The equipment will be manufactured in accordance with current standards regarding electrical safety (IEC 60601-). 1-2). In pressure ulcers that have been clinically proven to scale and in those at risk of developing pressure ulcers. It is a pulsed electric field therapy method that can be routinely applied to patients. Fixed plate (2) 5 equipped with a socket (5) for the cable connected to the operating ground of the network located inside It is a patient bed made of plastic or wood. Flexible rubber / plastic / PVC and approximately 2.5 cm top mattress (4) with flexible cover of thickness 0.5 mm to 1.0 mm thick aluminum alloy inside The invention includes a flexible active metal electrode (4.1). The dimensions given for the metal electrode (4.1) are preferred in the invention. This may vary depending on the different applications used, but it does not create a limiting effect. 10 The practitioner / physician should place this top mattress (4) over the area where a pressure ulcer is likely to develop or where a pressure ulcer has already formed. It is positioned. The control unit (6) is connected to the mains via the mains cable (5) and plug (6.2). by controlling the 220 V effective sine wave supply voltage it receives via a slicer / chopper circuit It will apply the voltage to the primary of the high-voltage transformer. A rectifier will be placed on the secondary of this transformer. This will be a circuit. Thus, the resulting adjustable pulsed high-voltage supply will be delivered to the patient at 15 The active top mattress (4) will be connected to the socket of the active top mattress (4). (Figure – 6) The cabling will be sufficiently flexible and will comply with existing medical device insulation standards. (IEC60601 AAMI / NFPA 99 are specific standards for medical devices.) From the device housing or It will not be affected by other devices around it through its cables, nor will it be able to affect other devices. (IEC 60601-1-2). The bottom mattress (3) with the fixed plate (2) and the active mattress (4) on the patient shall be waterproof. 20 In this regard, waterproofing standards for medical devices will also apply. Hip, knee or various other devices. MRI is used when performing procedures on patients with prostheses and implants in various body parts. The rules to be followed during imaging and examination will apply. Plate (2) electrode (4.1) The range of electric field values to be applied to the patient will be between 0 kV / m and 10 kV / m. Additionally, Parameters such as application time and repetition period can also be adjusted using the adjustment knobs on the control unit. 25 These values will be adjusted via the control unit's display. This device It can be operated without being switched off, without time restrictions, regardless of the device's operating conditions. It will not create conditions such as explosion, flash, fire, or smoke.
Claims
12 REQUESTS 1. Pressure ulcers, a clinically proven scaling condition that develops in bedridden and long-term bedridden patients. Pulsed electrical stimulation can be routinely applied in wounds of this type and in patients at risk of pressure ulcers. It is a pressure ulcer prevention device that provides protection; its features include: - Control unit (6) that provides pulsed electric field supply and control, 5 - fixed plate with reference electrode (2), - the active electrode which provides a homogeneous pulsed electric field with the aforementioned fixed plate (2). metal electrode (4.1), It includes.
2. A pressure ulcer prevention device in accordance with Request 1, its feature is; 10 on the support slats of the bed frame (1). It includes the aforementioned fixed plate (2) that is positioned.
3. A pressure ulcer prevention device that meets any of the above requirements, and whose feature is that it is interconnected. By positioning them in parallel, a homogeneous pulsed electric field is created, affecting the wound on the patient. It contains the aforementioned metal electrode (4.1) and fixed plate (2) which enables it to affect the tissue.
4. A pressure ulcer prevention device that meets any of the above requirements, and whose features include: 15 Active top mat (4) which prevents the metal electrode (4.1) from coming into contact with the patient's body. It includes.
5. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. The bed frame (1) should preferably be made of wood or PVC plastic.
6. A pressure ulcer prevention device that meets any of the above requirements, and whose feature is: the patient's 20 It includes a bottom mattress (3) which is laid on and positioned on the aforementioned fixed plate (2).
7. A pressure ulcer prevention device that meets any of the above requirements, and whose feature is; for the patient It includes the aforementioned top mattress (4) that is laid on top.
8. A pressure ulcer prevention device that meets any of the above requirements, and whose features include the aforementioned sub-requirements. The mattress (3) and the top mattress (4) must be made of waterproof material. 25 9. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. The flexible PVC top mat (4) protects the metal electrode (4.1) and ensures that the cover is flexible. It is made of a certain material. 13 10. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. the metal electrodes (4.1) inside the top mat (4) and the fixed plate (2) to the mentioned control unit (6) includes connecting cables (5) that provide the connection.
11. A pressure ulcer prevention device that meets any of the above requirements and whose feature is: electrical. To prevent leakage and ensure that electrical energy is transmitted directly to the ground, the aforementioned 5 It includes a conductive grounding cable (7) connected to the fixed plate (2).
12. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. setting that allows adjustment of the frequency and power of the pulsed electric field from the control unit (6). It includes buttons (6.1).
13. A pressure ulcer prevention device that meets any of the above requirements, and whose features include: (as mentioned in 10) The display (6.3) that controls the frequency and power setting of the pulsed electric field from the control unit (6) It includes.
14. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. The connection cable (5) that provides power to the control unit (6) is connected to the end of the cable and the two ends are connected to it. It contains a plug (6.2) that allows it to receive current by being plugged into a suitable socket. 15 15. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. the aforementioned connecting cables of the metal electrodes (4.1) inside the top mat (4) and the fixed plate (2) It contains socket connections that enable it to connect with (5).
16. A pressure ulcer prevention device that meets any of the above requirements, and whose feature is: active patient The mentioned top mattress (4) has a cover made of fireproof foil which provides flexibility, fireproof properties and waterproof structure. (4.2) includes.
17. A pressure ulcer prevention device that meets any of the above requirements, and whose feature is; connected to the mains. It receives the 220 V effective sine wave supply voltage from the mains via the connected cable (5) and plug (6.2). by controlling it via a slicing / chopping circuit, it applies the voltage to the primary of the high-voltage transformer and The mentioned control unit (6) 25 provides pulsed high voltage supply with rectifier circuit. It includes.
18. A pressure ulcer prevention device that meets any of the above requirements, and whose features are as described above. The range of electric field values to be applied to the patient between the fixed plate (2) and electrode (4.1) is 0 kV / m to It includes the aforementioned control unit (6) which enables it to be in the kV / m range.
