Pneumatic headache neuromodulation device targeting preemption protocol points, used in the treatment of primary headaches.

Abstract

The invention relates to a pneumatic headache neuromodulation device that targets preempt protocol points used in the treatment of primary headaches, possessing a technological infrastructure that transforms the PREEMPT protocol, which is critical in the treatment of primary headaches, into a needleless mechanism, and blocks pain transmission at the Trigeminocervical Complex (TCC) level by stimulating thickly myelinated A-beta nerve fibers in accordance with "Gate Control Theory"; its feature is:The device must include a flexible main body (1) positioned to be worn around the head, at least one airbag (2) integrated into this body, at least one pressure nodule (3) in mechanical interaction with the airbags (2), a control unit and algorithm that manages the operating parameters of the system and regulates the pressure intensity, frequency and pulsatile cycle parameters in accordance with the determined acute attack mode and chronic protective mode, at least one micro air pump (4) that produces pneumatic pressure and at least one rechargeable battery that powers the device.

Description

1 TARIFF PREEMPT IS USED IN THE TREATMENT OF PRIMARY HEADACHES. Pneumatic headache targeting protocol points. NEUROMODULATION DEVICE 5 Technological Field: This invention has implications for biomedical engineering, wearable medical technologies, and non-invasive procedures. Located at the intersection of neuromodulation fields, mechanotransduction 10 central nervous system using the principle of (conversion of mechanical stimulus into neural signal) It is a "mechanical neuromodulator" system that produces analgesic effects. The invention addresses critical points, particularly in the treatment of primary headaches, such as PREEMPT. Transforming the protocol into a needleless mechanism, "Gate Control Theory" (Gate According to Control Theory, by stimulating thickly myelinated A-beta nerve fibers, 15 A technology that blocks pain transmission at the trigeminocervical complex (TCC) level. Preempt protocol points used in the treatment of primary headaches with underlying infrastructure This relates to a pneumatic headache neuromodulation device that targets headaches. State of the Art: 20 Primary headaches include migraine, tension headache, and similar neurovascular-related pain types. encompassing these tables, quite common in society, and significantly affecting quality of life. These are clinical conditions that cause headaches. The underlying causes of these headaches include tension, fatigue, and stress. Due to a sedentary lifestyle and similar external factors, 25% of the muscles around the head... spasm, activation of myofascial trigger points, and peripheral sensation This involves the stimulation of receptors, particularly suboccipital, temporal, and frontal receptors. Muscle tension and neurovascular stimulation occurring in these regions; pain transmission pathways By activating it, it causes the onset of primary headaches. 2 Current literature and clinical studies aim to prevent or reduce primary headaches. Numerous treatment methods are used in practice. Current solutions are fundamental. pharmacological treatments, invasive neuromodulation methods, and manual therapy in four main categories: applications and commercial home massage devices is being evaluated. 5 In pharmacological treatment methods; non-steroidal anti-inflammatory drugs during acute attacks. medications (NSAIDs), triptans, ergotamine derivatives, and similar pain-suppressing agents beta-blockers, antidepressants, and antiepileptic drugs are used in prophylactic treatments. Medications are preferred. These methods aim to reduce pain transmission. However, 10 These drugs have gastrointestinal, hepatic, and cardiovascular side effects. Many patients cannot tolerate these medications. Furthermore, frequent use of painkillers is also common. Uncontrolled use results in "Medication-Overuse Headache". A secondary headache condition called "Headache - MOH)" can develop and clinically The condition can become chronic. Therefore, pharmacological methods require long-term use. 15 It has significant disadvantages in this respect. Other methods used to treat headaches include invasive neuromodulation. Applications include head and neck treatments, especially in the treatment of chronic migraine. 20 PREEMPT protocol is widely used. In addition, Baihui (GV20), Mechanical stimulation is applied to Fengchi (GB20) and similar acupuncture points using needles. The aim is to activate analgesic mechanisms. However, the aforementioned The invasive nature of these methods is a significant disadvantage. Needles These procedures carry a risk of infection and increase anxiety in patients with needle phobia. can increase and applications are performed by specialist physicians in clinical conditions This needs to be done. During an acute pain attack in the patient's home environment, this should be done. Since they are unable to administer the interventions on their own, accessibility to treatment and Ease of use remains limited. Another approach used in the management of primary headaches is manual therapy and These are physical interventions. These methods specifically target trigger points in the suboccipital region. 3 and massage of fascial structures, manual tissue inhibition and compression techniques These practices are being implemented. These practices aim to reduce muscle spasms and nociceptive stimulation. It aims to suppress. However, the fundamental problem with these methods is the implementer. The problem is dependence and lack of standardization. The intensity of the pressure applied by human hands, The duration, angle, and rhythm cannot be kept constant; there are variations in each practitioner and each session. This shows that, therefore, the medical dosage of compression cannot be objectively adjusted. And it becomes difficult to obtain scientifically repeatable results. Today, there are also various commercial massage devices and wearable devices for home use. Wellness products are also available. These devices are generally in the form of elastic headbands. It operates on the principles of vibration, heating, or general air compression. However, this These systems are mostly designed with a focus on relaxation and are clinically and anatomically relevant. It is not based on a neuromodulation approach. Current devices use PREEMPT points. or point pressure that anatomically targets specific neurovascular target regions. It does not have nodules. Also, there is uncontrolled and widespread air pressure around the head. 15 This procedure may place an unnecessary burden on the temporal arteries or the intraocular This can create undesirable mechanical stress on the pressure. In addition, standardized pressure ranges that will modulate the inflammatory response (for example) They do not offer pulsative pneumatic treatment algorithms operating at 40-100 mmHg. An example of the state of the art is "Acupressure Head" with reference number US2022339064A1. The patent document titled "Band Device" states that the device is designed to facilitate falling asleep. An improved acupressure headband device is described. This system includes the front and front... a headband with backing, fasteners that provide securing to the head, and It consists of temple pads aligned with the user's temple areas. The structure is based on 25 It is aimed at providing mechanical contact to the temporal region and is a clinical neuromodulation. It does not involve the application of controlled pulsative pneumatic pressure for specific purposes. Another example is US5792174A, "Natural head using acupressure points". In the patent document titled "pain reliever," it states that 30% of the scalp and upper back of the neck... A cap-like system that applies pressure to acupressure points is described. In this system, air is pumped into the space created between the inner and outer membranes. 4 acupressure points are applied via immobile protrusions located on the inner surface. pressure is applied. However, the pressure values ​​applied in this system... not controlled by clinically standardized pulsative pneumatic algorithms, optimized for targeting specific anatomical neuromodulation points no structure is found and mechanotransduction-based therapeutic pressure management 5 It appears that it is not provided at a sufficient level. In the system mentioned in the literature... Specific to different phases of headache, such as acute pain mode and chronic protective mode. Due to the lack of customized operating modes, it depends on the pain level. Mode options with adjustable specific pressure and frequency values. not offered. Therefore, the system only has a standard operating mode and different 10 A customizable application optimized for different types and intensities of pain. This is a disadvantage because it cannot provide that. In conclusion, current technical solutions involve systemic side effects and invasiveness related to drug use. mandatory implementation, dependence on experts, lack of standardization, high cost, 15 various factors such as the need for repeated application and insufficient clinical efficacy in home use It has disadvantages. Therefore, to the use of medication and invasive methods pain reliever via mechanotransduction, capable of relaxing muscle spasms without needing to be stimulated. capable of suppressing transmission, regulating vascular pulsation, and acting on trigger points. biochemical inflammation can be reduced and the frequency and severity of headaches can be more effectively managed, 20 A new technology is needed that can reduce it in a controlled and side-effect-free way. Description of the invention: PREEMPT 25 is an invention developed for use in the treatment of primary headaches. A wearable and non-invasive device that targets protocol points and operates on the pneumatic principle. The invention relates to a headache neuromodulation device. More specifically, it concerns episodic headaches. migraine, chronic migraine, tension-type headache (GTBA), and drug overuse headache It can be used in the management of primary headaches such as (MOH); it is controlled, measurable, and A medical device that provides neuromodulation via pulsatile pneumatic compression 30 It includes the system. The invention treats muscle spasms without the need for medication or invasive methods. It can relax, suppress pain transmission via mechanotransduction, and is vascular. It can regulate pulsation, reduce biochemical inflammation in trigger points, and A new method that can reduce the frequency and severity of headaches more effectively, controllably, and without side effects. It offers a technology. In this context, the invention relates to pharmacological treatments and Botox 5 an alternative or complement to invasive clinical procedures such as injections It is designed as a neuromodulation solution. The primary purpose of the invention is to diagnose chronic migraine, episodic migraine, and tension-type headache. In individuals who have taken medication, systemic drug side effects and "Drug Overuse Headache 10 It minimizes the risk of "Medication-Overuse Headache - MOH" and is safe, measurable, and The aim is to present a neuromodulation system that can be implemented in a home environment. Accordingly, the invention; modern neurophysiological principles, mechanotransduction mechanisms and anatomical Based on the “Synergistic Triple Effect” model, which brings together the targeting approach. It is designed. 15 Within the scope of this synergistic effect model, the invention; - At the neural level; principles of "Gate Control Theory" by stimulating A-beta fibers associated with low-threshold mechanoreceptors, Nociceptive pain transmission at the trigeminocervical complex (TCC) level 20 helps in suppression, - At the vascular level; especially the Superficial Temporal Artery (STA), for example. by creating controlled transmural mechanical pressure on extracranial arteries It modulates vessel wall tension and reduces vascular throbbing, - At the biochemical level, thanks to the pulsatile pneumatic pump effect, interstitial 25 by supporting fluid circulation, CGRP (Calcitonin Gene Related Peptide), Substance P and similar pro-inflammatory mediators are removed from the tissue via lymphatic drainage. It helps to remove it. The invention involves 30 points of the PREEMPT Botox protocol used in modern medicine for the treatment of migraine. acupuncture points that anatomically overlap with (especially Shao Yang and Yang Ming) (Baihui-GV20 and Fengchi-GB20 zones on the meridians) mechanically 6 This warns that the discovery thus bridges the gap between modern medical protocols and traditional Chinese medicine. It offers a hybrid neuromodulation approach that combines anatomical targets. The device developed within the scope of the invention is a flexible, wearable and ergonomic headpiece or headgear. It has a band structure and 5 segments that can adapt to the user's head anatomy. It comprises a structure that includes a microprocessor (MCU), a micro air pump, Closed-loop pressure sensors, pneumatic air ducts, inflatable air cushions and anatomical targeting positioned beneath those air cushions. There are nodules. Pressure nodules, PREEMPT points and related acupuncture points. They are positioned to align with the zones. Thus, in classic massage devices, 10 Instead of a random distribution of pressure, the pressure is focused on specific neurovascular target points. Controlled mechanical compression is provided. The device is a preferred choice. in the arrangement, specific neurovascular and / or anatomy corresponding to the user's head anatomy to enable controlled mechanical pressure to be applied to acupuncture target areas Anatomical targeting nodules are positioned. In this arrangement; frontal 15 seven in the region, four each in the right and left temporal regions, and six in the occipital region. A total of at least twenty-one targeting points are established. Thus, the device is associated with the anatomical regions defined in the PREEMPT protocol. By aligning with specific points, it allows for the application of regional and controlled pneumatic compression. It provides. 20 One of the key features of the invention is that manual therapies applied by human hands are subjective. The system eliminates the need for a closed-loop sensor feedback system to target the structure. Measurable, standardized and repeatable in regions with a range of 40-100 mmHg. It can apply pulsatile pneumatic compression. Thus, physical neuromodulation 25 For the first time, the application is being made "dosable" like a medical drug. The mechanical stimulation applied within the scope of this invention is pulsatile in the frequency range of 0.01-3 Hz. This is achieved through dynamic pulsation in fixed printing systems. The observed neural adaptation (habituation) is inhibited, and analgesics are used for 30 days during treatment. This contributes to maintaining the effect. Pulsatile cycles also cause reactivity in the tissue. It creates a "biochemical flushing" effect by generating hyperemia. 7 It brings about increased interstitial fluid circulation and removes inflammatory mediators from the tissue. It facilitates removal. The discovery reveals various scientific factors that play a role in the complex pathophysiology of primary headaches. It aims to contribute to the solution of problems. In this context; 5 - Modulation of central and peripheral sensitization, - Suppression of pain transmission at the trigeminocervical complex (TCC) level, - Mechanical control of extracranial vascular distension, - Reducing neurogenic inflammation, - Removal of mediators such as CGRP and Substance P, 10 - Reducing energy crises in myofascial trigger points, - Relieving muscle spasms, - Integration of attack management and prophylactic protection processes. that is intended. The invention has different operating modes: acute attack mode and chronic (protective) mode. It has the following features: In acute attack mode, the device provides short inflation-deflation cycles and high pressure. using intravenous fluid levels (approximately 80-100 mmHg) to provide rapid analgesic support. It aims to activate A-beta fibers through rapid pulsative stimulation in this mode. By increasing the number of gates, the "Gate Control" mechanism is ensured to function at its maximum level, 20 By mechanically reducing the vessel radius, vascular pulsation is suppressed, and The parasympathetic response is supported via the trigeminocardial reflex (TCR). According to Laplace's Law, blood vessel wall tension; 𝜎 = P × R ℎ In line with this equality, the pulsating sensation is reduced by decreasing the radius of the vessel. This contributes to the mechanical suppression of pain. The invention has different operating modes: acute attack mode and chronic (protective) mode. The device subject to the invention has 30 modes, including acute pain mode and chronic protective mode. Thanks to the availability of customized operating modes, it can be adjusted according to the pain level. There are standard mode options with specific pressure and frequency values. 8 In acute attack mode, the device uses short inflation-deflation cycles and high pressure levels. It aims to provide rapid analgesic support using approximately 80-100 mmHg. In this mode, the activation of A-beta fibers is increased through rapid pulsative stimulation, creating a "gateway". The "control" mechanism is ensured to function at its maximum level, and the vessel radius... By mechanically reducing its size, vascular throbbing is suppressed and trigeminocardial 5 The parasympathetic response is supported via the reflex (TCR). Additionally, the pain attack... by applying frequent and higher pressure to myofascial points during the procedure Relaxation and relief are provided. In chronic or protective mode, the device uses lower pressure levels (approximately 40-60 10 biochemical washing using (mmHg) and longer pulsative cycles, myofascial It aims to provide relaxation and tissue rehabilitation. In this mode, rhythmic pneumatic By compressing, interstitial fluid circulation is increased, thus preventing the release of inflammatory molecules. Removal via lymphatic drainage is supported. Additionally, it is applied to trigger points. Thanks to the reactive hyperemia that occurs after the application of prolonged ischemic compression, 15 Tissue oxygenation is increased and the sensitivity of myofascial trigger points is reduced. is being reduced. In addition, within the scope of the invention, headache points, acupuncture Because it includes PREEMPT protocol points as well as other protocol points, the head Myofascial points, which cause pain due to muscle spasms in the surrounding areas, are located at a higher anatomical level. It can be targeted with accuracy. 20 The invention differs from electrical neuromodulation devices in that it uses electric current. It operates on a mechanical pneumatic principle without using any other method. Thus, it relieves paresthesia and burning sensations. risk of contraindications in individuals with sensory disturbances, skin irritation, or those using pacemakers. is minimized. In addition, the system simultaneously targets both nerve tissue and muscle tissue. 25 By creating a synergistic effect, it affects not only neurological but also myofascial trigger point-related issues. It also contributes to pain management. The invention differs from traditional wellness massage devices in that it is designed for specific anatomical needs. It includes a clinically based neuromodulation algorithm targeting specific goals. These 30 In this respect, the PREEMPT protocol is a needle-free and home-based method of innovation. the rationale behind "non-invasive dynamic Botox" which transforms into a mechanical system. 9 the first targeted mechanical headache neuromodulation that provides "simulation" It has the characteristic of being one of the devices. The invention, thanks to its portable, lightweight and ergonomic design, allows users to use the device at home or at work. This allows the user to use it on-site or while traveling. Thus, the user has 5 The device can be used without needing expert assistance the moment the patient feels the onset of a headache attack. by activating it, acute intervention can be initiated, and during attack-free periods, a protective mode can be used. It can be used prophylactically. In these respects, the meeting brings together neurology, algology, physical therapy, rehabilitation, complementary medicine and home medicine. Non-invasive, doseable, targeted technologies that can be used in various health technology fields. An innovative medical device that provides focused, pulsatile pneumatic neuromodulation. It is a system. The structural and characteristic features and all advantages of the product subject to the invention are given below in 15 Thanks to the detailed explanation written with figures and references to these figures, more This will be clearly understood, and therefore the evaluation should also take these figures and detailed explanations into account. It must be done with this in mind. Explanation of the Figures: 20 The invention will be described by referring to the attached figures, so that the features of the invention can be explained. It will be understood and appreciated more clearly, but the purpose of this invention is this obvious It is not about limiting it with regulations. On the contrary, the invention is defined by the accompanying claims. all alternatives, modifications and 25 that can be included within the defined area The aim is to cover their equivalences. The details shown are only for the present invention. It is shown to illustrate the preferred arrangements and both the methods shaping both the rules and conceptual features of the invention in the most useful way and It should be understood that these drawings are presented to provide an easily understandable definition. In these drawings; Figure 1 shows an example view of the system that is the subject of the invention. Illustrations that will help understand this invention are shown in the attached image. They are numbered and their names are given below. Explanation of References: 1 Flexible Main Body 2 Airbags 3 Pressure Nodules 4 Air Pumps Detailed Description of the Invention: The invention relates to PREEMPT protocol points used in the treatment of primary headaches. It relates to a pneumatic neuromodulation device targeting. The system consists of a flexible main body (1), Micro air pump with airbags (2), pressure nodules (3), control unit and algorithm 15 (4) and includes rechargeable battery components. The invention offers a solution for treating headaches without the need for medication or invasive methods. to relax muscle spasms, to suppress pain transmission via mechanotransduction, regulating vascular pulsation and biochemical inflammation at trigger points 20 It aims to reduce it. The flexible main body (1) allows the device to fit ergonomically around the head. It is the basic load-bearing structure. This structure allows for the controlled direction of air pressure. It provides and supports the stable operation of the pneumatic system. This flexible main body (1) 25 The fabric is preferably a heat-welded (HF Weld) TPU coated non-stretch outer fabric, and a flexible inner fabric. It includes membrane and PREEMT anatomical point-focused ergonomic pads. Airbags (2) are compressed air produced by the micro air pump (4) 30 where it is stored and creates mechanical compression by inflating and deflating in a controlled manner. These are chambers. These air cushions (2) are localized to target anatomical regions around the head. It creates a neuromodulatory effect by applying pressure. 11 Pressure nodules (3) (PREEMPT), in or under airbags (2) They are positioned semi-rigid structures that convert pneumatic pressure into point mechanical actuation. It transforms. These pressure nodules (3) affect the frontal, temporal, corrugator and occipital muscles. to be aligned with the PREEMPT protocol points corresponding to their regions It is designed so that, unlike classic massage systems, it targets 5 points instead of random ones. Focused mechanical stimulation is provided. Furthermore, the invention offers a preferred... The design aims to include all 21 PREEMPT anatomical points. in areas with dots to provide complete guidance for head circumference in terms of size It is designed to have more points than points. The control unit and algorithm form the brain of the system. The user chooses... pressure level and frequency according to modes (acute attack mode or chronic protective mode) and manages the inflation-deflation cycles. In a preferred arrangement of the invention Pulsatile rhythm (2 sec ON / 15 sec OFF) according to the mode selected by the user (acute / chronic) It manages the system. Furthermore, the system operates using a closed-loop control logic. 15 It enables its operation based on data from pressure sensors. The pump (4) is dynamically controlled and the safe operating range is maintained. In this invention, when the power is cut off for safety reasons, the "Normally Open" valve opens, and this It enables the belt to turn off automatically. The micro air pump (4) is the pneumatic power supply of the system. This pump operates with low voltage. It is a compact structure and pressurizes the airbags (2) in a controlled manner. It sends air. Thus, rhythmic inflation and relaxation occur within the flexible main body (1). movements are being created. The invention provides for controlled pneumatic compression and relaxation through the combined operation of these components. These cycles form loops. These loops connect to target PREEMPT points around the head. It contributes to the modulation of pain transmission pathways by applying mechanical stimulation. When the system is started, the frequency and pressure determined by the control unit are 30. According to its parameters, the micro air pump (4) inflates the air cushions (2). This inflation During this process, pressure nodules (3) apply point pressure to the target muscle regions. 12 Then the air is released to initiate the relaxation phase, and this cycle is repeated rhythmically. is doing. Higher pressure and shorter cycles are applied during acute attack mode, while chronic protective measures are used. In this mode, tissue relaxation is achieved by using lower pressure and longer cycle durations, and 5 Biochemical circulation is supported. Thanks to this structure, the invention is non-invasive. A drug-free, portable, and user-controlled pneumatic headache device. It offers a neuromodulation system. All technical and other specifications mentioned in each request are followed by a reference number. 10 These reference numbers are provided solely to facilitate understanding of the requests. These reference numbers have been used, therefore they are for illustrative purposes only. It should not be thought that any of the elements specified limit the scope. This is fundamental. developing a wide variety of applications related to the subject of the invention, around the concepts. It is possible, and the invention cannot be limited to the examples described here, but mainly to claims 15 as stated. A technical expert can assess the novelty of the invention and similar structures. by using and / or this structure in the relevant technique It is clear that this can be applied to other areas with similar purposes. Therefore, such 20 the criteria for structures are innovation and especially exceeding the known state of the art. It is also obvious that he will be deprived of it. 30

Claims

13 REQUESTS 1- The invention describes preempt protocol points used in the treatment of primary headaches. This relates to a pneumatic headache neuromodulation device, and its features are: - Flexible main body positioned to be worn around the head (1), 5 - at least one airbag integrated into this fuselage (2), - at least one pressure nodule in mechanical interaction with airbags (2) (3), - managing the system's operating parameters and determining the acute and chronic attack modes. In protective mode, pressure intensity, frequency and pulsating cycle 10 control unit and algorithm that regulates its parameters, - at least one micro air pump (4) that produces pneumatic pressure and - The device must contain at least one rechargeable battery to power it. 2- The device mentioned in Claim 1, its characteristic is; 15 as defined in the PREEMPT protocol. Frontal, corrugator, temporalis, and occipitalis muscle regions, and Traditional Chinese Medicine. Head circumference acupuncture associated with "Yang" energy flow within the scope of (TCM). pressure nodule (3) which is positioned to anatomically overlap with the points It is characterized by its inclusion. 3- The device mentioned in Claim 1, its feature is; the operating mode selected by the user. according to the system's pressure level, pulsating frequency, and inflation-de-escalation cycle times It is characterized by including a dynamically adjusting control unit. 4- The device mentioned in Claim 1, its feature is; 25 that will provide an ergonomic fit to the head circumference. designed in this way and alignment of pressure nodules (3) with anatomical target areas It is characterized by having a flexible main body (1) with a flexible and segmented structure. It is done. 5- The device mentioned in Claim 1, its features include a control unit and the algorithm it contains. 30 Airbags (2) are controlled by the closed-loop control principle. 14 micro air pump (4) that produces controlled and measurable pneumatic pressure inside It is characterized by its inclusion. 6- The device mentioned in Claim 1 is characterized by its pressure sensor controlled by the control unit. It operates within a closed-loop system managed by feedback and has a target of 5. It includes a micro air pump (4) which stops automatically when pressure is reached. It is the characterization of the situation. 7- The device mentioned in Claim 1, its feature is; pneumatic inside airbags (2). point mechanical compression by transmitting pressure through the flexible main body (1) 10 It is characterized by containing pressure nodules (3) which are converted into force. 8- The device mentioned in Claim 1, its characteristic is that the system produces pulsatile pressure in the range of 0.01-3 Hz. by generating a cycle, it reduces neural adaptation (habituation) and provides sustained therapeutic efficacy. It is characterized by having pressure nodules (3) which it possesses to provide support. 15 9- The product system mentioned in Claim 1 is characterized by its definition in the PREEMPT protocol. Anatomical muscle regions and “Yang” energy within the framework of Traditional Chinese Medicine (TCM). Double pressure nodules (3) of the acupuncture points corresponding to the flow It is characterized by stimulation using the dual mapping principle. 20 30

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