Flow enhancer device

Abstract

The invention relates to the flow enhancer device (1) that consists of applicators (3, 4), a power socket (5) and a belt (2), can be applied to the abdominal region and is used in cases of insufficient blood supply (nourishment) between the mother and the foetus or in cases of uteroplacental insufficiency due to preeclampsia that may occur during pregnancy, to continue development without medication, to provide a drug-free treatment alternative, and to prevent and treat preeclampsia by utilizing the vasodilator effect of radiofrequency (RF) and pulsed magnetic field (DMA).

Description

[0001] FLOW ENHANCER DEVICE

[0002] Technical Field

[0003] The invention relates to a flow enhancer device, which, thanks to its applicability to the abdominal region, is created by utilising the vasodilator effect of radiofrequency (RF) and pulsed magnetic field (DMA) in cases of uteroplacental insufficiency due to preeclampsia that may occur during pregnancy and which increases the synthesis of endothelial nitric oxide synthase enzyme in the endothelial layer of the vessels in the region where it is applied, thus increasing nitric oxide production.

[0004] State of the Art

[0005] Preeclampsia is a complication seen during pregnancy. This condition generally causes high blood pressure that occurs with pregnancy. Toxemia of pregnancy is more common after the 20thweek, which corresponds to the period after the second half of pregnancy, and creates a dangerous situation for pregnant women.

[0006] Preeclampsia is defined as hypertension (DBP > 90 mm / Hg) and proteinuria (>300 mg / 24 hours) developing after the 20thweek of pregnancy, but is also characterized by platelet activation, increased capillary permeability, generalised vasoconstriction, decreased plasma volume and decreased fetoplacental blood flow; and it is shown as one of the leading causes of maternal mortality and morbidity, foetal growth retardation and perinatal deaths. Preeclampsia has a pathophysiology characterised by vascular dysfunction that causes multiple organ involvement seen in 3-5% of women, primarily affecting placental formation and the maternal microvascular system. The clinical condition of the patient determines the degree to which the system is affected.

[0007] In preeclampsia, there is insufficient trophoblastic invasion and a problem with pregnancy-specific remodelling in spiral arteries, but this alone is not sufficient for the development of the maternal syndrome. Many studies have shown that there is an increase in oxidative stress originating from the placenta in preeclampsia and that oxidative stress products increase in the maternal circulation, while antioxidant activity decreases.

[0008] As a result, the blood flow from the mother to the foetus (uterine blood flow) decreases, especially due to the increase in resistance in the placenta. Although preventive treatments such as low-dose aspirin, which are thought to increase uterine blood flow, are currently used, there is limited data on increasing blood flow using other methods or devices.

[0009] In recent years, there have been views that preeclampsia and the associated foetal growth restriction (the foetus not reaching its growth potential) may be secondary to the mother's (maternal) inability to achieve sufficient increase in the amount of heart blood pumping during pregnancy. During pregnancy, the amount of blood pumped per minute, called cardiac output, increases by 30-50%. If this increase is not sufficiently achieved, there may be a relative decrease in uterine blood flow and an increase in placental oxidative stress and vasoconstrictive products that lead to the clinical picture of preeclampsia secondary to the decreased blood flow. Particularly in this case, pharmacological or other methods that help increase placental blood flow may be preventive or even therapeutic in terms of preeclampsia and foetal growth restriction.

[0010] In the prior art document numbered KR102427694B1 , a method of treating stenosis using a pulsed magnetic field is described. The effect of a pulsed magnetic field on increasing blood flow is described. The pulsed magnetic field stimulation coil system uses an elliptical concentric coil with a cross-section of 12 cm wide and 4.5 cm long. Mentioned document provides the process of changing or increasing the speed of movement of red blood cells. It does not cause any increase in nitric oxide synthesis by increasing the production of endothelial nitric oxide synthase.

[0011] The document numbered US201 1263925A1 in the state of the art describes a pulsed magnetic therapy device. The aim of the device in the document is to provide an electrical circuit that provides current to an induction coil device placed at the working end of a hand-held apparatus in order to induce a pulsed magnetic field from a user's body. The device describes sending pulsed magnetic fields to certain parts of the body to reduce inflammation, increase immune function, and increase blood flow.

[0012] The prior art document numbered CA2514210A1 describes electromagnetic activation of gene expression and cell growth. It describes a method for accelerating the cell cycle by delivering an effective amount of electromagnetic energy to a cell. It also provides a method for activating a cell cycle regulator by delivering an effective amount of electromagnetic energy to a cell. In addition, the invention provides a method for activating a signal transduction protein; a method for activating a transcription factor, a method for activating a DNA synthesis protein, and a method for activating the receptor. A method for inhibiting an angiotensin receptor and reducing inflammation is provided. Mentioned document provides the creation of a method for providing an enzyme synthesis or preventing inflammation by providing electromagnetic energy to the cell. However, mentioned document lacks a device and the features of enabling the device to produce nitric oxide synthase and the like.

[0013] In the state of the art, there is no device that addresses the problem of inadequate trophoblastic invasion in preeclampsia and pregnancy-specific remodelling in spiral arteries. After preeclampsia develops, there is no specific drug treatment, but starting low-dose (100-150 mg / day) acetylsalicylic acid (aspirin) in pregnancies at risk for preeclampsia in the first half of pregnancy (before 16-20 weeks of gestation) can delay the risk of developing preeclampsia. Apart from this, the currently generally accepted approach is that the main treatment for preeclampsia is delivery. From this perspective, preeclampsia, especially the one that develops in the early weeks of pregnancy, carries a significant risk for both the mother and the foetus and is an important cause of permaturity. The lack of a treatment modality for the use of a medical-like device in the prevention and treatment of preeclampsia has necessitated an R&D study in this area.

[0014] The Aim of the Invention

[0015] The main aim of the invention is to create a 2-part Flow Enhancer device that can be applied to the abdominal region, to continue development without medication in cases of insufficient blood supply (nourishment) between the mother and the foetus or in cases of uteroplacental insufficiency due to preeclampsia that may occur during pregnancy, to provide a drug-free treatment alternative, and to prevent and treat preeclampsia by utilising the vasodilator effect of radiofrequency (RF) and pulsed magnetic field (DMA). The aim of the invention is to ensure that the pulsed magnetic field with the features adjusted via the control box mounted on the belt located on the abdominal region is applied exactly to the tissue target. In addition, it is to ensure that, when desired, the RF field provides constant energy to this target separately or together. The applicators are designed in a way that will not cause side effects on healthy tissues in terms of their physical and technical features. The use of an eight-shaped or butterfly-shaped coil applicator allows the practitioner to direct and concentrate the magnetic field vector to an area of several square centimetres determined by ultrasound.

[0016] The aim of the invention is to provide a Flow Enhancer device that can provide a more protective effect on target tissues by using a 27.12 MHz radiofrequency electromagnetic field and a 1 Hz (Hertz) - 0.5 mT (millitesla) pulsed magnetic field.

[0017] Brief Description of The Invention

[0018] Diseases or anomalies that may occur in the foetus during pregnancy can be determined before birth and treatment-oriented interventions can be applied. Today, many prenatal structural anomalies can be detected in the womb. Some of these anomalies have high mortality rates or are fatal, are accompanied by mental retardation and severe disabilities or incompetences, and termination of pregnancy can be discussed with the family and offered as an option.

[0019] Our device, designed to continue development without medication and to provide a drug-free treatment alternative in cases where the blood supply (nourishment) between the mother and the foetus is insufficient, consists of 2 parts, and the device control unit and 2 different applicators can be fixed on the magnetic belt (“magneto belt”).

[0020] The applicator that will create a pulsed magnetic field is a special coil and the shape of this coil will be in the form of an 8. Such coils are also used in devices called TMS (Transcrenial Magnetic Stimulator) in the scientific literature. The aim of using these coils is to better direct and focus the field. In the Flow Enhancer device, this type of Eight-shaped or Butterfly-shaped coil applicator will be used. Thus, the practitioner will be able to direct and concentrate the magnetic field vector to the area of several square centimetres determined by ultrasound. Our simulation studies show that the long axis of the elliptical applicator structure is 10 cm (centimetres) and the short axis is 6 cm. The coil will be manufactured with 200 turns with 0.3 mm (millimetre) enamelled copper coil conductor. The RF (radiofrequency) applicator is essentially a special antenna. The wavelength of the 27.12 MHz (Megahertz) frequency signal is around 1 1 metres. Therefore, the literature suggests spiral printed geometries on PCBs for such large wavelengths. We also use the spiral type PCB antenna geometry that we decided to use in our preliminary studies.

[0021] Pulsed Electromagnetic Field (DMA) increases vasodilation in the area where it is applied. It also increases the synthesis of tissue growth factors such as vascular endothelial growth factor.

[0022] Description of Drawings

[0023] Figure - 1 General View of Flow Enhancer Device

[0024] Figure - 2 General View of Flow Enhancer Device Magneto Belt

[0025] Figure - 3 General View of Flow Enhancer Device Pulsed Magnetic Field Applicator

[0026] Figure - 4 General View of Flow Enhancer Device Radiofrequency Applicator

[0027] Figure - 5 General View of Flow Enhancer Device Power Socket

[0028] Reference Numbers:

[0029] 1. Flow Enhancer Device

[0030] 2. Magneto Belt

[0031] 2.1. Belt Lock

[0032] 3. Radiofrequency Applicator

[0033] 4. Pulsed Magnetic Field Applicator

[0034] 5. Power Socket

[0035] 6. Shielded Cable

[0036] 7. Control Unit

[0037] 7.1. Screen

[0038] 8. Cable

[0039] 8.1. Adapter Detailed Description of the Invention

[0040] The Flow Enhancer device (1 ), which is the subject of the invention, consists of an RF (radiofrequency) applicator (3), a DMA (pulsed magnetic field) applicator (4), an adapter (plug) (8.1 ) that provides power to the system, and a magneto belt (2) that carries the applicators (3, 4) as detailed in Figure - 2. The power socket (5) is also connected to this magneto belt (2). The power socket (5) is connected to the control unit (7) with a shielded cable (6) and transmits the power from the adapter (8.1 ) to the applicators (3, 4). The magnetic and electromagnetic field generating applicators (3, 4) can each be operated together or separately.

[0041] The Flow Enhancer device, which will be used to treat conditions such as insufficient blood supply (nourishment) between the mother and the foetus or uteroplacental insufficiency due to preeclampsia that may occur during pregnancy, comprises a coil that provides the generation of a pulsed magnetic field, an oscillator that provides the generation of radiofrequency, a control unit (7) that allows the control of magnetic field signals and the adjustment of pulsed magnetic field or radiofrequency parameters when applied to the abdominal region, and a power socket (5) that is connected to the control unit (7) with a shielded cable (6). It has a pulsed magnetic field applicator (4) seen in Figure - 4 or a radiofrequency applicator (3) seen in Figure - 3, which prevents inadequate nutrition between the mother and the foetus by increasing vasodilatation in the region where it is applied. It also has a power socket (5) seen in Figure - 5, which allows the working values of the applicators (3, 4) to be adjusted and the energy coming from mentioned control unit (7) connected to a power unit to be transferred to the applicators (3, 4). In addition to all these, it has a magneto belt (2) that carries thereon the power socket (5) and the applicators (3, 4). It is the belt (2) that allows the pulsed magnetic field or radiofrequency received from mentioned applicators (3, 4) to be applied to the abdominal region. The belt (2) comprises an adjustable belt lock (2.1 ) that allows the it to be fixed to the abdominal region. There is an oscillator that can produce 15 V / m electric field from 30 cm away by producing radiofrequency energy at a frequency of 27.12 MHz. There is a coil that allows the DC supply voltage of the DMA applicator (4), which is a magnetic field generator, to produce a pulsed magnetic field in the form of 50% square waves. It comprises a cable (8) that provides the connection between the control unit (7) and the power source. It has a coil that provides a magnetic field of 0.5 millitesla in the target tissue by feeding with 200 turns, 1 Ampere effective pulsed current. There is a touch screen (7.1 ) that allows the frequency value and power on the control unit (7) to be adjusted and controlled at certain intervals.

[0042] The oscillator that forms the RF power circuit in the Flow Enhancer device (1 ) is a crystal oscillator and is connected wirelessly to the PCB antenna with a single transistor. The circuit is powered by 12 V (volt) DC (constant and direct current) and 0.8 Watt RF energy is supplied to the PCB antenna input. Therefore, an electric field of approximately 15 V / m (volt / meter) is created on the target tissue perpendicularly with the RF applicator (3).

[0043] For the pulsed magnetic field (DMA), the DMA applicator (4) feeds the coil from a 0.5 Volt-12 Volt adjustable DC (constant and linear current) power source with microprocessor control.

[0044] The Flow Enhancer device (1 ) has a structure that can create a homogeneous pulsed electromagnetic field in the desired working area, with adjustable power, repetition period and frequency. The target magnetic field value of the device is at most 0.5 mT (millitesla) (+ / - 10%) and the electromagnetic field value is at least 15 V / m at 27.12 MHz (Megahertz). The frequency value to be set via the touch screen (7.1 ) on the control unit (7) of the device (1 ) is in the range of 0-2 Hz (Hertz) and its power is in the range of 0.1 mT - 1 mT and the RF electric field value is fixed and at the electromagnetic field value of 15 V / m. If desired, the operating time of the device (1 ) can be adjusted in 15-minute steps via the device (1 ). (Figure - 1 )

[0045] The device (1 ) has an inductive DMA applicator (4) unit with a suitable number of turns for the pulsed magnetic field and produces a field of 0.5 mT (+ / - 10%) in the desired setting range.

[0046] The applicators (3, 4) of the device (1 ) can be fixed on the magneto belt (2) upon the recommendation of the relevant physician. The applicators (3, 4) have a locked mechanism on the target area. Thus, the magnetic and electromagnetic fields at the desired value can be easily focused on the target area.

[0047] The DC supply voltage of the magnetic field generator operates with 50% duty cycle, so the coils that produce the magnetic field produce a pulsed magnetic field in the form of 50% duty cycle square waves under this intermittent supply. The electromagnetic field generator is basically an integrated oscillator / amplifier circuit with quartz crystals. It is fed with constant DC voltage. The electromagnetic field generator can produce RF energy at a frequency of 27.12 MHz (ISM Medical band, IEEE C95) and can produce 15 V / m electric field from a distance of 30 centimetres.

[0048] The applicators (3, 4) can work together or separately with the principle of 24 / 7 without resting, and they can also be automatically turned on and off with a timer. The stopwork intervals can be set as 15 minutes.

[0049] The power is supplied to the power sources with cables (8) as far as possible and does not produce extra noise to the electromagnetic environment. A magnetic or ferromagnetic device box, metal holder, fastener, nail, screw etc. is not used in the application and power environment.

[0050] The device (1 ) operates heavy duty and without being affected by the humidity and temperature changes of the environment. It can also operate without disrupting EMC / EMI performance, without creating noise in the environment, without being affected by ambient noise and without changing the electrical parameters to which it is set.

[0051] The device (1 ) is capable of providing RF energy and pulsed magnetic energy at fixed frequency and fixed amplitude, which are set separately or together, at the target point and at target values without being affected by each other.

[0052] Preliminary studies and simulation results have shown that if a 200-turn coil is fed with 1 Ampere effective pulsed current, a field of 0.5 mT can be created in the target tissue. The maximum feed current of 1 Ampere causes a negligible temperature increase around the coil (0.5°C -1°C).

[0053] The results of preliminary studies and experiments show that 0.5 mT is a sufficient value for beneficial effects.

[0054] DMA and RF energy can be applied together or separately in the Flow Enhancer device (1 ). Basically, this is what makes the device (1 ) original. The beneficial effects are further increased in both methods accepted by the literature.

[0055] The Flow Enhancer device (1 ), which comprises RF (radiofrequency)-EMA (electromagnetic field) and DMA (pulsed magnetic field), increases nitric oxide production by increasing the synthesis of the endothelial nitric oxide synthase enzyme in the endothelial layer of the vessels in the region where it is applied. This increased nitric oxide can cause vasodilation in many vessels in the body, especially the coronary arteries that feed the heart. It has been proven that these methods can cause expansion in vessels even behind bones that have a hard and compact structure (Asci, H., Savran, M., Comlekci, S. et al. Combined Pulsed Magnetic Field and

[0056] Radiofrequency Electromagnetic Field Enhances MMP-9, Collagen-4, VEGF Synthesis to Improve Wound Healing Via Hif-1 a / eNOS Pathway. Aesth Plast Surg (2023). https: / / doi.org / 10.1007 / s00266-023-03450-8). In this publication and other publications in the literature on this subject, it is shown that in addition to vasodilation, cell migration due to the electrostatic gradient of cells into damaged areas is caused by the pulsed magnetic field. Therefore, the Flow Enhancer device (1 ) will be able to have a more protective effect on target tissues by using a 27.12 MHz radiofrequency electromagnetic field and a 1 Hz-0.5 mT pulsed magnetic field.

Claims

CLAIMS1. A flow enhancer device (1 ) for use in the treatment of conditions such as inadequate blood flow (nourishment) between the mother and the foetus or uteroplacental insufficiency due to preeclampsia that may occur during pregnancy, characterized by comprising:- a coil that enables the creation of a pulsed magnetic field,- an oscillator that provides radiofrequency generation,- a control unit (7) that allows the magnetic field signals to be controlled and the pulsed magnetic field or radiofrequency parameters to be adjusted when applying to the abdominal area, and- a power socket (5) connected to mentioned control unit (7) via a shielded cable (6).

2. The flow enhancer device (1 ) according to Claim 1 characterized by comprising; a pulsed magnetic field applicator (4) or a radiofrequency applicator (3) which prevents inadequate nutrition between the mother and the foetus by increasing vasodilation in the area where it is applied.

3. The flow enhancer device (1 ) according to any of the previous claims characterized in that; mentioned supply socket (5) which enables the adjustment of the operating values of mentioned applicators (3, 4) and the transfer of energy from mentioned control unit (7) connected to a power unit to the applicators (3, 4).

4. The flow enhancer device (1 ) according to any of the previous claims characterized by comprising; a magneto belt (2) that carries mentioned power socket (5) and applicators (3, 4).

5. The flow enhancer device (1 ) according to any of the previous claims characterized in that; mentioned belt (2) that enables the application of the pulsed magnetic field or radiofrequency received from mentioned applicators (3, 4) to the abdominal region.

6. The flow enhancer device (1 ) according to any of the previous claims characterized in that; mentioned belt (2) comprises an adjustable belt lock (2.1) which allows it to be fixed to the abdominal area.

7. The flow enhancer device (1 ) according to any of the previous claims characterized in that; mentioned oscillator that can produce 15 V / m electric field from 30 cm away by generating radiofrequency energy at a frequency of 27.12 MHz.

8. The flow enhancer device (1 ) according to any of the previous claims characterized in that; mentioned coil that allows the pulsed magnetic field applicator (4), which is a magnetic field generator, to produce a pulsed magnetic field in the form of 50% square waves from the DC supply voltage.

9. The flow enhancer device (1 ) according to any of the previous claims, characterized by comprising; a shielded power cable (8) that provides the connection between mentioned control unit (7) and the power supply.10.The flow enhancer device (1 ) according to any of the previous claims characterized in that; mentioned coil that provides a magnetic field of 0.5 millitesla in the target tissue by feeding with 200 turns, 1 Ampere effective pulsed current.

11. The flow enhancer device (1 ) according to any of the previous claims, characterized by comprising; a touch screen (7.1) which enables the adjustment and control of the frequency value and power on mentioned control unit (7).

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