A device implantable into the body in a minimally invasive manner and utilizing rotating magnetic field technology

Abstract

This invention relates to an energy harvester (7) and charger (1) system that utilizes rotating magnetic field technology to meet the energy needs of biomedical devices that are implantable into the body by a minimally invasive method. This technology aiming to solve the problem of battery depletion in devices such as pacemakers will significantly reduce the dependence on surgical interventions. The charger (1), electric motor (3), and permanent magnets (6) provide the energy harvester (7) with a variable magnetic field. The energy harvester (7) converts alternating current into direct current by generating electric current in its coil / coils (8) with this magnetic field. The generated energy is stored in a rechargeable battery (12) in accordance with the levels required by biomedical devices. The system works with low-frequency magnetic fields to keep SAR values within safe limits and minimizes negative effects such as tissue heating. It also ensures efficient energy production. The materials used in the energy harvester are biocompatible and toxic effects are avoided. The invention reduces the risks of surgery and increases patient comfort with its minimally invasive nature. It provides economic and health advantages by reducing the frequency of battery replacement of implantable devices such as pacemakers. It can also be used in other biomedical devices such as defibrillators, neurostimulators, cochlear implants, and retinal implants.

Description

[0001] DESCRIPTION

[0002] A DEVICE IMPLANTABLE INTO THE BODY IN A MINIMALLY INVASIVE MANNER AND UTILIZING ROTATING MAGNETIC FIELD TECHNOLOGY

[0003] Technical Field of the Invention

[0004] The invention relates to biomedical devices using rotating magnetic field technology that are implantable into the body in a minimally invasive manner. In the device of the invention, the magnetic field to which the energy harvester is exposed does not affect the pacemaker electronic circuit. In addition, since the energy harvester does not come into contact with the organs, it does not cause mechanical stress to the organs. In the invention, the rotational frequency of the motor is lower than other wireless energy transfer methods, thus minimizing the risks associated with tissue heating.

[0005] State of the Art

[0006] Pacemakers are vital devices that are widely used to treat cardiovascular conditions, particularly bradycardia, conduction disorders, and heart failure. However, one of the major disadvantages of these devices is that the batteries used as the energy source have a limited lifespan. This requires periodic surgical replacement of the batteries and can lead to problems for patients, such as risk of infection, complications, and reduced quality of life. Currently, several researches are being conducted on alternative technologies that work with energy harvesters to meet the energy needs of pacemakers. However, the number of technologies developed in this area is limited and still under research and development. Also, the technologies developed have not been investigated especially within the lifespan of pacemakers, which is 5 years.

[0007] Energy harvesters are basically technologies that aim to meet the energy needs of medical devices by converting environmental energy inside or outside the body into electrical energy. The main goal of these technologies is to reduce the need for surgical intervention, prolonging the lifetime of the devices and improving the patient's quality of life. The main energy harvesters being studied today are listed below.Piezoelectric Energy Harvesters generate electricity from the natural mechanical movements of organs such as the heart and lungs. However, this method often suffers from low energy efficiency and biomechanical stress.

[0008] Triboelectric Energy Harvesting generates electricity by friction with the movement of the organs. While this technology shows promise in terms of energy efficiency, the durability of the devices and their reliability in long-term use are questionable. Due to the frictional force, wear and breakage may occur on the surface over time. This can negatively affect the power output of the energy harvester.

[0009] Wristwatch application is also another way of harvesting energy. Electric current is generated through a coil using the motion generated by the beating of the heart. However, the energy harvesters used in this method are very heavy and can trigger the risk of heart infection. The size of the device is also a problem.

[0010] In the ultrasonic energy transfer method, research is carried out on the conversion of ultrasonic sound waves sent from outside the body into electrical energy inside the body. As acoustic waves propagate through organs and tissues, energy is dissipated. This method has a low energy transfer rate and should be considered with caution due to the possible biological effects of cellular vibrations induced by ultrasonic sound signals. Because this can cause stress on the cells in the long term, which can lead to chronic problems.

[0011] The method of generating electricity with biofuel cells is an innovative and promising technology. The main problem with this method is that although the current level generated is sufficient, the voltage levels are not sufficient to operate biomedical devices. In order to overcome this problem, researchers have carried out various studies by connecting biofuel cells in different numbers of living organisms in series. This technology also has stability issues as it uses enzymatic reactions. For these reasons, energy harvester technologies should be longer lasting and should not cause problems in the body during long-term use.Wireless energy transfer methods work with high-frequency signals, which creates negative effects such as tissue heating and also electromagnetic interference. Due to the metal cage structure of pacemakers, application problems may arise. Also, the high frequency of wireless energy transfer can cause heating in the tissues.

[0012] In this context, the development of a low-frequency and highly efficient energy harvester working with minimally invasive methods offers several advantages over current technologies. This type of technology not only meets the energy needs of pacemakers, but also opens up a wide range of uses for other implantable biomedical devices. Given the limitations of the technologies working with energy harvesters available today, more innovative and effective solutions are needed in this field.

[0013] Summary and Objects of the Invention

[0014] The invention offers significant advantages in terms of SAR (Specific Absorption Rate). Today's wireless energy transfer technologies generally use high frequencies in the kHz-MHz range, leading to heat generation in human tissue, harmful effects at the cellular level, and high SAR values. The low frequency (kHz and below) used in the proposed project will significantly reduce SAR values and prevent tissue overheating. This prevents undesirable biological effects such as cellular hyperthermia caused by overheating, apoptosis, and necrosis. Preventing the risk of tissue heating caused by high-frequency devices offers a safe use in long-term energy transfer. These features demonstrate that the invention offers a unique and innovative solution not only in terms of energy efficiency but also in terms of safe use of biomedical devices. Thus, patient comfort is increased thanks to low SAR values and efficient energy transfer, while longterm safe use of pacemakers and other biomedical devices is made possible. The energy harvester will not be covered with a metal cage. Polydimethylsiloxane (PDMS) will be used for isolation from the environment. This will prevent electromagnetic shielding caused by metals. The electronic circuits of the energy harvester and the pacemaker will be located in different places. Thus, the magnetic field to which the energy harvester is exposed will not affect the electronic circuit of the pacemaker. Due to the absence of moving parts in the energy harvester, the risk of failure is assessed to be lower compared to other energy harvesting methods. Furthermore, since the energy harvester will not come into contact with the organs, this will prevent mechanical stress on the organs. This constitutes another important advantage of theinvention, especially when compared to piezoelectric nanogenerators (PENG) and triboelectric nanogenerators (TENG). The magnetic field produced by the neodymium magnets in the charger easily passes through human skin, allowing energy transfer. This technology makes it possible to transfer energy wirelessly. Desired power levels can be reached by changing the speed of the rotating magnets. This advantage allows it to be used not only for pacemakers but also for devices with higher power requirements, such as defibrillators.

[0015] The invention relates to the development of a new energy harvester and charger integrated structure that generates electricity by the principle of electromagnetic induction using a magnetic field rotating outside the skin in a minimally invasive manner in order to meet the energy needs of implantable biomedical devices such as pacemakers with a minimally invasive method and offers the advantage of minimizing the risks of tissue heating and electromagnetic interference by operating at a lower frequency compared to existing technologies while allowing wireless energy transfer. This invention aims to significantly reduce reliance on surgical interventions by charging pacemakers externally through wireless energy transfer.

[0016] The general objects of the invention can be listed as follows.

[0017] Providing efficient energy transfer with low-frequency magnetic field rotation technique and reducing the frequency of surgical operations by keeping the specific absorption rate (SAR) value within safe limits and storing the generated energy,

[0018] Not causing damage or irritation to the skin during charging,

[0019] Prevent contact of toxic conductors used in the receiving coil such as copper wire with body tissues and fluids,

[0020] Protecting the electronic circuit of devices such as pacemakers and defibrillators from magnetic fields,

[0021] Reducing the frequency of replacement of devices such as pacemakers and defibrillators to prevent loss of time for both the patient and the doctor, Prevent possible complications during surgery due to reoperation, Minimizing economic loss due to surgical procedures,The features of the invention in terms of design are listed below.

[0022] • Minimally Invasive: The invention realizes wireless energy transfer without a physical connection.

[0023] • High Efficiency: The high-density energy transfer created by the rotating magnetic field on the receiving coil (8) quickly meets the energy demand of the device.

[0024] • Safe Operation: It includes special designs to prevent electromagnetic interference and tissue damage.

[0025] • Flexibility: The adjustable structure of the coil (8) and the magnet rotation speed allows the energy generation level to be controlled.

[0026] • Wide Application Potential: In addition to pacemakers and defibrillators, the invention can also be used in neurostimulators, cochlear implants, retinal implants, and many other biomedical devices, demonstrating the versatility and wide range of applications of the technology. According to the features of the device to be used, energy transfer can be provided with the same method by making updates in the context of the invention.

[0027] Description of the Drawings

[0028] Fig. 1. Representative view of the charger in the device of the invention.

[0029] Fig. 2. Representative view of the energy harvester in the device of the invention.

[0030] Fig. 3. Representative view of the flexible band in the device of the invention.

[0031] Description of the References in the Drawings

[0032] Descriptions of the figures realized to achieve the object of this invention

[0033] are presented below.

[0034] 1. Charger

[0035] 2. Charger fixing arm

[0036] 3. Electric motor

[0037] 4. On-off switch

[0038] 5. Screen

[0039] 6. Permanent magnet7. Energy harvester

[0040] 8. Coil

[0041] 9. Core

[0042] 10. Mu-metal

[0043] 11. Rectifier circuit

[0044] 12. Rechargeable battery

[0045] 13. Flexible band

[0046] 14. Protective cap

[0047] 15. Power cable

[0048] 16. Biocompatible outer coating

[0049] Detailed Description of the Invention

[0050] The invention relates to the development of a new energy harvester (7) and charger (1) integrated structure that generates electricity by the principle of electromagnetic induction using a magnetic field rotating outside the skin in a minimally invasive manner in order to meet the energy needs of implantable biomedical devices such as pacemakers with a minimally invasive method and offers the advantage of minimizing the risks of tissue heating and electromagnetic interference by operating at a lower frequency compared to existing technologies while allowing wireless energy transfer.

[0051] The invention consists of two main parts, the charger (1) and the energy harvester (7). The energy transfer is initiated by aligning the charger (1) and the energy harvester (7) perpendicular to each other and at an optimum distance. The charger (1) comprises a rotating electric motor (3). Different types of motors, such as pneumatic motors, can also be used for this purpose if desired. The charger (1) has at least one permanent magnet (6) integrated with a rotating arm connected to the free rotating rotor portion. These magnets are integrated with the rotor and rotate at the same frequency. The charger (1) has a protective cap (14) to keep the user and patient away from the rotating part. The charger (1) has a power cable (15) or power source (battery, etc.) and is equipped with an on / off switch (4) and a speed regulator (not shown in Figures). The charger (1) has a charger fixing arm (2) for position fixing. The rotation speed of the charger (1) motor can be changed at the desired frequency (computer, etc.) and monitored on a screen. The main task of the charger (1) is to provide a variable magnetic field to the energy harvester (7) inside the skin. The magnetic field intensitychanges as the magnets are aligned on the coil (8) inside the skin. The magnetic field change causes the magnetic flux in the coil (8) to change. According to Faraday's law of induction, this flux change creates an electromotive force (emf) or voltage in the coil. When the circuit is completed, this voltage turns into electric current and generates energy. The second main part in the invention is the energy harvester (7). The energy harvester (7) is the main part that generates electrical energy with a variable magnetic field. The energy harvester (7) may comprise one or more coils (8). This coil (8) or coils generate electric current according to the principle of induction with a variable magnetic field. The generated alternating current is converted to direct current by means of a rectifier circuit and the generated energy is stored in a rechargeable battery (12) in accordance with the levels required by biomedical devices. The coil (8) comprises a core (9) to guide the magnetic field and increase the charging efficiency.

[0052] The core (9) of the coil (8) can be coated with a biocompatible outer coating. This coating can be made with Polydimethylsiloxane (PDMS), Polytetrafluoroethylene (PTFE-Teflon), Polyethylene (PE) or other similar biocompatible materials. The magnetic field can pass through these materials and be transferred to the coil (8). Mumetals can be used to block the magnetic field. The mu-metal (10) may be contained in the invention to protect the electronic circuit in the energy harvester (7). Mu-metal (10) will cover the energy harvester (7) so as to leave only the core (9) part exposed. In this way only the core (9) part of the coil (8) will be predominantly exposed to the magnetic field. In the invention, the main pacemaker circuit and the energy harvester (7) are intended to be located in different locations. In this way, the pacemaker electronic circuit will not be affected by this magnetic field during the charging process. A flexible band (13) can be located with the charging portion left as a gap on the patient's chest region to provide alignment during charging and to provide additional mechanical support to the skin. This band has a flexible, belted or fastened construction, so it can be easily used during charging, regardless of patient weight and size. After charging the battery with the electric current generated by the energy harvester (7), the patient can continue to use the pacemaker or devices such as defibrillators and neurostimulators until the next charging.Industrial Application of the Invention

[0053] This invention provides great comfort for patients by reducing the need for surgical intervention. In addition, thanks to its low-frequency operating principle, it prevents malfunctions that may occur in the electronic circuits of biomedical devices and increases the reliability of the device. This method, which facilitates energy transfer under the skin, performs wireless energy transfer both safely and effectively. This invention has industrial applicability and can be used in pacemakers, defibrillators, neurostimulators, and other implantable biomedical devices. The commercialization potential of the technology will provide a significant competitive advantage in both the national and international market.

Claims

CLAIMS1. A device utilizing a rotating magnetic field from outside the skin in a minimally invasive manner for meeting the energy requirements of implantable biomedical devices, characterized in that it comprises:- at least one charger (1), positioned outside the body (on the skin), comprising at least one permanent magnet (6) and an electric motor (3) integrated with a rotating arm connected to the free rotating rotor part, which initiates the energy transfer by aligning the energy harvester (7) perpendicular to each other and at an optimum distance,- at least one energy harvester (7) positioned inside the body (subcutaneously), comprising one or more coils (8), generating electrical energy with a variable magnetic field.

2. A device according to claim 1, characterized in that said charger (1) comprises a protective cap (14) for keeping the user and the patient away from the rotating part.

3. A device according to claim 1, characterized in that said charger (1) comprises a power cable (15) or a power source (battery, etc.).

4. A device according to claim 1, characterized in that said charger (1) comprises an on-off switch (4) and a speed regulator.

5. A device according to claim 1, characterized in that said charger (1) comprises a charger fixing arm (2) for position fixing.

6. A device according to claim 1 , characterized in that it comprises a rechargeable battery (12) that stores energy generated in accordance with the levels required by biomedical devices.

7. A device according to claim 1, characterized in that it comprises mu-metal (10) on the energy harvester (7) so as to leave only the core (9) part exposed for the protection of the electronic circuit inside the energy harvester (7).

8. A device according to claim 1 , characterized in that it comprises a flexible band (13) with the charging portion left as a gap on the patient's chest region to provide alignment during charging and to provide additional mechanical support to the skin.

9. A device according to claim 1 , characterized in that the core (9) portion of said coil (8) is coated with a biocompatible outer coating.

10. A device according to claim 7, characterized in that said coating is made of Polydimethylsiloxane (PDMS), Polytetrafluoroethylene (PTFE-Teflon), Polyethylene (PE) or other similar biocompatible materials.

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