Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0551—Spinal or peripheral nerve electrodes
  • A61N1/0556—Cuff electrodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/36053—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
  • A61N1/36064—Epilepsy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
  • A61N1/36082—Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
  • A61N1/36096—Mood disorders, e.g. depression, anxiety or panic disorder
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/36128—Control systems
  • A61N1/36135—Control systems using physiological parameters
  • A61N1/36139—Control systems using physiological parameters with automatic adjustment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/36128—Control systems
  • A61N1/36146—Control systems specified by the stimulation parameters
  • A61N1/36167—Timing, e.g. stimulation onset

Definitions

• the invention relates to a device providing an electrical-based nerve stimulation with a special algorithm used in the field of medicine, particularly in the surgical treatment of certain neurological and psychiatric diseases such as Epilepsy and depression.
• VNS vagal nerve stimulation
• VNS vagal nerve stimulation
• the vagal nerve literally means “idle, wandering”.
• the reason behind is that it is the nerve with the longest course outside the skull. After leaving its nucleus in the medulla oblongata (spinal cord bulb), it leaves the skull through the jugular foramen, passes between the carotid artery and the jugular vein in the neck region and travels to the intestinal region. It carries 80% afferent and 20% efferent fibers.
• an electrode is placed on the left vagal nerve in the neck region. Its distal part to the electrode is delivered to the chest area with the help of a tunneler and integrated into the neurostimulator there.
• the electrode has 3 spirals. The part close to the skull is the negative electrode, the middle one is the positive electrode, and the spiral below is the anchor part that prevents the system from dislodging and provides strength.
• an action potential is generated by electrical stimulation from the negative electrode.
• the task of the positive electrode is not to lower the electrical stimulation below the neck area, thus protecting the patient from possible side effects.
• Providing cyclic stimulation (such as 30 seconds every 5 minutes), this device provides current-based electrical stimulation. Patients are also given a clock-shaped magnet for extra activation of the system. Generally, clinical responses become evident in the 12th week of stimulation.
• the antiepileptic effect is mediated through the afferent fibers of the vagus nerve.
• the most valid action mechanism is that the nucleus solitary tractus (NST) is stimulated by the electrical energy given to the vagus and this tractus contains connections with the locus serelus (LC). Stimulation of the LC increases noradrenaline levels in the central nervous system, resulting in an antiepileptic activity.
• NST nucleus solitary tractus
• LC locus serelus
• Stimulation of the LC increases noradrenaline levels in the central nervous system, resulting in an antiepileptic activity.
• Early- term ( ⁇ 12 weeks) results are encouraging, especially in the pediatric age group. In long-term results, effective results have been shown in focal, multifocal and generalized seizures.
• the electrode lacks the ability to surround the vagus nerve 360 degrees at once due to its spiral structure.
• the effectiveness of the system lies in the ability to generate an action potential in the vagus nerve by means of a negative electrode.
• the surgical field is very closely adjacent to the carotid artery and jugular veins. Due to its current structure and design, the electrode has serious application difficulties when placing it on the vagus nerve during the surgical procedure and may cause injury to the vagus nerve and these vessels.
• electrical stimulation by generating an action potential through the vagus nerve produces a fixed electrical output.
• the sensitivity of patients to electrical stimulation decreases and tolerance to electrical stimulation develops in patients due to pulses delivered at a constant fixed frequency.
• the signal transmitted to the electrode by a battery implanted under the skin under the collarbone is unidirectional and contains direct current.
• the positive pole of the electrode prevents the direct current from being transmitted to the organs located below the neck and innervated by the vagus nerve, it sometimes fails to fully fulfill this task at high voltages, and the working order of vital organs such as the stomach, heart and intestines may be disrupted.
• the batteries used in present systems are Li-ion and LiPo batteries, the per-cell safety zone is usually between 3V (fully discharged) and 4.2V (fully charged), but can be discharged down to about 2.8V without problems. Discharge below this level can cause irreversible/irreparable damage. For this reason, these batteries often have a built-in safety device that prevents overdischarge. Conversely, overcharging can also be dangerous.
• Li-Po batteries have a lower number of charge cycles than LiFePo4 (1000@0.2C ratio, IEC Standard). The projected/estimated lifetime of the Li-ion battery is approximately 3 years from the date of manufacture.
• the battery life is predicted to be 3 years, there is a loss of performance over time due to the chemistry of the battery. In fact, the battery used can even create unwanted electrical activity and give a high electric current to the patient and can be life-threatening.
• the computer interface systems used with the device providing vagus nerve stimulation work only through the operating system that the manufacturer has obliged to use, and a computer containing that system and performs all operations.
• a malfunction that may occur in the computer interface of the device during surgery causes communication problems. As a result, the surgery time may be prolonged, the reliability of the system cannot be evaluated, the side effects of the electrical stimulation on the heart and respiratory system cannot be observed, and it cannot be determined whether the device is optimally placed.
• the device cannot be activated from time to time during and after surgery. For all these reasons, the likelihood of the patient benefiting from the treatment is reduced.
• the present invention relates to a device providing electrical-based nerve stimulation with a new algorithm over the vagus nerve in the treatment of neurological and psychiatric diseases, developed to eliminate the aforementioned disadvantages and bring new advantages to the related technical field.
• the most important aim of the invention is to provide patients with a better treatment response possibility during and after VNS applications.
• the electrode structure of our invention is superior to the documents in the known state of the art for reasons such as the output of the pulses transmitted to the nerve from the device being formed with an algorithm we call BOLA and a new electrode system designed to eliminate the problem of hoarseness, which is a side effect of vagus nerve stimulation.
• One of the features that distinguish the invention from existing products is that the pulses are transmitted to the vagus nerve with an algorithm called BOLA. This algorithm was created by calculating the pulses generated by the body's own nervous system as a result of research.
• the new stimulation parameters the effectiveness of the treatment is increased, and the number and frequency of seizures are controlled. With this new system, negative side effects caused by the unidirectional current are prevented.
• the device generates a 1 min ON, 2 min OFF therapeutic signal compatible with cardiopulmonary activity.
• Another aim of the invention is to provide easier application in VNS surgery with the new electrode design. In this way, it is possible to minimize the possibility of injury to vital vessels and organs in the nerve and surrounding tissue.
• Another aim of the invention is to shorten the surgery time due to the ease of application. In this way, the patient will be under general anesthesia less and will be less affected by the possible side effects of anesthesia.
• the incidence of infection after VNS surgeries is given as 8-10% in the literature. In such cases, the implanted system is first tried to be saved with antibiotic treatment. If not successful, the system is removed. The length of anesthesia has a direct effect on infection rates. Thanks to the invention, the surgery time will be shortened and infection rates will decrease. In this way, the cost of anti-biotherapy will be minimized and patients will be protected from the possible side effects of anti-biotherapy on organs.
• Another aim of the invention is to prevent financial loss by reducing the doses of antiepileptic drugs used due to the increase in the effectiveness of VNS (Vagus Nerve Stimulation) and to protect patients from the possible side effects of drugs.
• Another aim of the invention is to solve battery-related problems in existing and old systems.
• Figure 2 With the new electrode designed, a structure that surrounds the vagus nerve 360 degrees at once was created.
• Figure 3 Detailed view of the parts of the new designed electrode that will contact the nerve.
• Figure 6 The repetitive and biphasic therapeutic basic signal pattern/model that varies with age, gender, position and magnetic stimulation during the ON periods used by our invention
• Figure 7 Monophasic therapeutic wave of existing companies.
• Figure 3-B Electrode interior view (Positive x,y,z poles are Px, Py, Pz and Negative x,y,z poles are Nx, Ny and Nz respectively)
• Said invention relates to a device providing electrical-based nerve stimulation with a new algorithm over the vagus nerve in the treatment of neurological and psychiatric diseases.
• the new designed electrode can completely surround the vagus nerve ( Figure 2). In this way, the signals to be sent by the electrode can be transmitted to the nerve without loss. Thanks to this new electrode, maximum performance is obtained from the device.
• the negative pole, positive pole and anchor parts of the electrode are manually locked at the level of the silicone hole thereon after a full rotation around the nerve.
• a cuff electrode structure was used to contact the nerve at multiple points ( Figure 3).
• This bipolar, implantable electrode consists of 3.16 L stainless steel biocompatible wires that are enclosed in a fully biocompatible silicone tube. This silicone tube provides extra protection for the wires and prevents a possible short circuit.
• the connection part of the electrode to the device has a plug-and-play connector instead of the jack used in present devices, which is more ergonomic and will not cause difficulty for the surgeon during surgery.
• This connector prevents the device from contacting with liquid and eliminates problems such as disconnection of the electrode from the device due to body movements.
• this new designed electrode it is aimed to be easily placed without damaging the vagus nerve.
• this nerve is adjacent to the carotid artery and the vagus nerve is the main exit point of the entire nervous system of the body, a possible error during a surgical procedure on this nerve can cause irreversible consequences.
• This electrode was designed to eliminate all possible errors during surgery and to ensure that the patient gets maximum performance from the device after surgery and to eliminate any problems that may arise with the device.
• the pads that contact the nerve in the electrode are made of a softer silicone to prevent damage to the nerve. In this way, by surrounding the vagus nerve with a softer silicone sheath, the therapy signals transmitted over this nerve without damaging the nerve will be transmitted to the brain without loss. Since it surrounds the nerve softly, nerve injuries that may occur during implantation are eliminated.
• this new electrode system which will be formed in a segmented way within each pole, will surround at least 60% of the nerve, the loss of transmitted signals is minimized.
• a segmented electrode system was developed as a solution to this problem.
• the advantage of this segmented electrode is to prevent hoarseness that occurs as a side effect after implantation.
• the positive and negative parts of the electrode are divided into three parts ( Figure 4).
• Figure 4 When desired, it can send therapy signals to either 120-degree or 240-degree part of the nerve that it surrounds 360 degrees. In this way, these electrodes, which can be controlled by the software of the device, can turn off the signal in the area close to the vocal cords and prevent hoarseness.
• This new implant system (the Vns device is referred to as a complete set (system) since it consists of several different components) has an operating system that is most suitable for human physiology and comprises 32 different therapy modes, as well as modes that can be completely customized according to the needs of the patient by connecting wirelessly with the device. Thanks to this system, which we call BOLA (Body Own Language Approach) (stimulation in body language), we can use both pre-programs and programs that can be added later on the device.
• the device in the part of the Vns device placed on the body, which we call the battery, has a processor. Thanks to this processor, the battery can control the device and adjust the therapy modes according to the patient.
• the BOLA algorithm (a kind of algorithm that changes dynamically by the microprocessor with the patient's position information, depending on the predefined age and gender-specific heart rate and respiratory rate), the properties of the predefined treatment waves change.
• the device is activated by selecting the most suitable one for the patient from 7 different algorithms including these treatment waves.
• the suitability of the patient is selected by evaluating the information in the disease reports.
• the structure of the therapeutic stimulating signal varies continuously as explained in a scientific article called the BOLA approach or HRP (Heart-Respiration-Position) method, which has previously entered the medical literature (In the known state of the technique, 30 seconds ON and 5 minutes OFF time is generally used, and the treatment is started with the same low current for each patient called titration, and the most appropriate treatment pattern is tried to be found with gradual FM and gradual amperage increase. In the latest models, they adjust by actively detecting the heart rate).
• BOLA approach Heart-Respiration-Position
• the detection system of differences in patient position is applied. It is known that heart and respiratory frequencies change in vertical, sleeping and horizontal positions (1-3). According to the position information from the accelerometer in the processor, it will be possible to check whether the patient is lying on his/her side and a different treatment protocol can be initiated accordingly.
• the therapeutic signal that the invention sends to the patient operates in the physiological stimulation frequency ranges (12 and 25 Hz Hertz) that are accepted in the literature and used in commercial vagal nerve stimulators.
• the wave pattern is bipolar.
• the pumps located in the cell wall, especially in the neuron cell wall in the ultrastructural plan are considered as capacitors in the modeling of electronic science, so it is more appropriate to use a biphasic alternating current model approach rather than the direct current in order to generate electron current through capacitor structures.
• the physiological axiom potential measured during nerve conduction and flowing through nerve axon fibers is exactly the same way (Figure 5). In this model, we will use bipolar pulses to provide treatment support (Figure 6).
• LiFePO4 batteries are used for long battery life. LiFePO4 batteries provide advantages with different properties than other batteries: They have a slightly lower operating voltage of about 3.2V-3.3V, a minimum discharge voltage of 2.8V and a maximum charge voltage of 3.6V.
• LiFePO4 batteries have a more constant discharge voltage and are considered to provide better safety than other Lithium-based batteries.
• Other advantages of Lithium-based rechargeable batteries comprise much faster charging and higher discharge rates than the other chemistries mentioned and the number of charge cycles (> 2000@0.2C rate, IEC Standard) which usually translates into longer life if not full, but the energy density is lower than a regular Li-Ion cell (Li- Co) and LiFePO4 average lifetime is about 5-7 years.
• LiFePO4 is a safer cathode material than LiCoO.
• the Fe-P-0 bond is stronger than the Co-0 bond so when forced (short-circuited, overheated, etc.) it is much more difficult to remove the oxygen atoms. This stabilization of redox energies helps rapid ion migration.
• LiFePO4 When lithium moves out of the cathode in a LiCoO cell, CoO2 undergoes non-linear expansion, which affects the structural integrity of the cell.
• the fully lithiated and non-nitrated states of LiFePO4 are structurally similar, meaning LiFePO4 cells are more structurally stable than LiCoO2. No lithium remains at the cathode of a fully charged LiFePO4 cell, whereas in a LiCoO2 cell, about 50% remains at the cathode. LiFePO4 is highly resistant to oxygen loss, which causes an exothermic reaction in other lithium cells.
• LiFePO4 does not decompose at high temperatures.
• the battery in the device’s generator can usually operate from 1 to 3 months, depending on the settings.
• the battery has a charge capacity of about 500-1000 times. And the battery will gradually lose its power. At the end of the battery life, if it is not recharged, the stimulation will stop completely.
• this software can be connected to the PC software via the external/external control unit and pulse/wave pulse frequency adjustment (FM: Frequency Modulation) can be done.
• FM Frequency Modulation
• the effectiveness of the system is proportional to the action potential generated by the electrical stimulation transmitted to the nerve. Since the contact to the nerve will be at maximum level thanks to the new electrode, electrical stimulation will be performed more easily, an action potential will be generated more easily, and treatment effectiveness will be achieved in a shorter time.
• negative and positive poles are added to the electrode and a thin silicone layer is added between the nerve and the electrode in the anchor part.
• This layer is designed to be separated from the electrode during surgery and left as a thin membrane on the nerve.
• nerve, vessel and neighboring organ injuries are prevented in revision surgeries and in cases where the electrode must be completely removed.
• the revision surgery time is shortened.
• the duration of hospital stay and the economic burden on social security institutions are minimized (Figure 3).
• the device is able to read the patient’s physiological position information thanks to the sensors integrated into the device and sends information to the main processor that the patient is asleep, enabling the therapy to operate in low mode during sleep. It is also optimized for short periods of rest.
• a device providing electrical-based nerve stimulation with a new algorithm over the vagus nerve in the treatment of neurological and psychiatric diseases characterized in that it comprises
• At least one spiral, bipolar implantable electrode which penetrates into at least one biocompatible silicone tube to prevent a possible short circuit from occurring by extra containment of the biocompatible wires, which comprises a plug-and-play connector at one end to be connected to the implant and a bipolar stimulator at the other end, which comprises negative positive poles and a thin (having a thickness of 2 mm) silicone layer in the anchor part, which surrounds the vagus nerve 360 degrees at once, which provides the transmission of the signals transmitted from the device and comprising at least one pad surrounding the nerve, which enables the signals going to the region close to the vocal cords to be turned on and off in the desired region through the software of the device,
• the device comprises at least one rechargeable hybrid power supply which provides the energy required for the operation of the device.
• the invention preferably comprises at least one battery device, preferably with a processor that enables different therapy modes to be set in accordance with human physiology and that comprises an accelerometer to enable the patient’s position information to be understood.
• a processor that enables different therapy modes to be set in accordance with human physiology and that comprises an accelerometer to enable the patient’s position information to be understood.
• an operating system that can be wirelessly connected to the battery device and can be loaded with modes that can be completely customized according to the needs of the patient.
• the invention comprises at least one integrated sensor that reads the patient’s physiological position information and sends information to the main processor that the patient is asleep and enables the therapy to operate in low mode during sleep.
• Said pads are preferably made of soft (40 shore resistance coefficient) radiopaque silicone material.
• the positive and negative parts of the electrode are divided into three parts.
• Said signals are of a bipolar wave pattern.
• Said power supply is preferably lithium iron phosphate (LiFePO4).
• an electrode that, when desired, sends therapy signals to either 120- degree or 240-degree part of the nerve that it surrounds 360 degrees.
• SPI Serial Peripheral Interface
• MEMS Microelectro Mechanical System
• VNS vagus nerve stimulation
• HBP stimulation modes were created.
• Physiological studies have shown that heart rate and respiratory frequency vary depending on the age, gender and position of the patient, such as standing up in daily life and lying down in sleep. Considering these physiological facts, parameters were created according to the patients, including eight age groups for each gender (4-11, 12-17, 18-25, 26-35, 36-45, 46-55, 56- 65, 65?).
• the device which can be programmed with a program installed on a computer or smart device, provided 32 different modes to choose the most appropriate mode from the clinical examination of each patient by the doctor.
• the vagus is the 10th cranial nerve. Both vagus nerves are not symmetrical with respect to their cardiac junction.
• the left vagus and the right vagus comprise more parasympathetic fibers, whereas the left vagus has fewer connections to the ventricles and the right vagus has connections to the cardiac atria. This is why the left vagus is preferred in vagal anatomy to avoid cardiac effects when stimulation occurs.
• the left cervical vagus comprises 80% afferent and 20% efferent fibers. Afferent fibers are mostly not myelin sheathed.
• Efferent fibers are also mostly parasympathetic, unmyelin sheathed and extend to the viscera, while myelin-sheathed fibers extend to the vocal muscles.
• Afferent fibers carry information from the abdominal, thoracic and neck regions to the brain and terminate in the “Nucleus Tractus Solitarus”. Vagal afferent fibers extend bilaterally through the Nucleus Tractus Solitarus to the spinal cord and the noradrenergic and serotonergic neuromodular systems of the brain.
• the Locus Coeruleus has a noradrenergic (NA) and the Raphe Nuclei has a serotonergic (SE) effect on the entire cortex and other brain structures.
• NA noradrenergic
• SE serotonergic
• Vagal afferent synapses utilize glutamate and aspartate as excitatory, GABA neurotransmitters as inhibitory, as well as acetylcholine and neuropeptides.
• the electrical signals reaching the brain through the VNS affect the Action Potentials of neurons, regulating ion channels (Na/K and Ca/Cl) and polarization-depolarization. This leads to a reduction or cessation of seizures.
• the first programming is performed on the 1 st or 2nd day after surgery.
• the first program starts with 0.25 mA current. This value is very low and no effect is expected, it is only for patient familiarization.
• the battery sends the set current for the set time. Off time indicates the time when the battery is not active, i.e. not operating.
• the implanted device is designed as a three-layer sandwich with a minimal LiFePO4 rechargeable battery on top and a thin (0.3 mm) plaque with an internal charging coil on top.
• the main treatment programs are loaded into the system.
• an electrode is placed on the left vagal nerve in the neck region.
• the distal part of the electrode is delivered to the chest area with the help of a tunneler and integrated into the neurostimulator there.
• the device is activated in the days after surgery.
• Parameters such as patient, age, gender, diagnosis of the disease, current treatment, medications used are evaluated and the appropriate program is selected from 32 different programs. Depending on the age, gender and position of the patient, it provides a treatment in accordance with the body language. In addition, stimulations are provided in accordance with heart rhythm + respiratory frequency + metabolic rate.

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• 2022
  • 2022-12-05 EP EP22904822.8A patent/EP4444405A4/de active Pending

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