A DEVICE FOR PERFORMING THREE-DIMENSIONAL VOLUMETRIC REDUCTION OF THE SOFT TISSUES OF THE UPPER AIRWAYS.

Abstract

The invention relates to a device with its own power source and motorized unit, developed for use by otolaryngologists and head and neck surgeons in the treatment of pathologies causing sleep-related breathing disorders such as turbinate hypertrophy, uvula elongation or prolapse, soft palate prolapse, and tongue base enlargement. The device is designed to insert a nitinol thread, selected in appropriate size for the target tissue, into the tissue via a spiral carrier needle. Upon heat activation, this thread transforms into a smaller spiral from its memory, thereby enabling real-time three-dimensional volumetric reduction of soft tissues obstructing the upper airway.

Description

1 TARIFF THREE-DIMENSIONAL VOLUMETRIC SURVEYS OF THE SOFT TISSUES OF THE UPPER AIRWAYS A DEVICE TO PERFORM THE REDUCTION. Technical Area The invention was developed by otolaryngologists and head and neck surgeons. for use in treating nasal polyps that cause sleep-related breathing disorders. (concha hypertrophy), elongation or sagging of the uvula, sagging of the soft palate, tongue 10 Developed for use in the treatment of pathologies such as root growths, etc. It relates to a device that has a power supply and a motorized unit. State of the Art 1) Treatment of Inferior Turbinate Hypertrophy: The most common cause of sleep-related breathing disorders is nasal congestion. It develops into 'inferior turbinate hypertrophy,' also called the growth of turbinates. The inferior turbinate is located in the nose. It is an anatomical structure that plays an important role in physiology. It is responsible for the filtration of inspired air. Besides heating and humidifying, there are 20 important functions such as regulating nasal airflow. They have functions. Due to various reasons, edema of the inferior turbinates or Due to its growth, it causes reduced nasal airflow and symptoms of nasal congestion. This situation arises, and in addition to reducing quality of life and productivity, It also plays an important role in the pathogenesis of obstructive sleep apnea syndrome. Inferior turbinate A range of medical treatments are used in the treatment of hypertrophy. Medical treatment 25 If this fails, surgical intervention is often required. Several surgical techniques have been described for the surgical treatment of inferior turbinate hypertrophy. There are still disagreements about which of these techniques is the most optimal. These techniques differ in that the tissue that is cut and left behind is 30. It is the quantity and type of symptoms. As our knowledge of nasal physiology increases, symptoms can be minimized. surgical techniques that allow for recovery but preserve function to the maximum extent possible Efforts are being made to improve it. a. Concha lateralization: Nowadays, nasal concha lateralization due to concha hypertrophy. The most commonly used method in the surgical treatment of concha obstruction is concha lateralization. 35 2 This is the method. In this method, the inferior concha is fractured first inwards, then outwards. It is lateralized. Application number TR2017 / 15833 also concerns concha lateralization. The application concerns three small hills, a broad tip, and a concave structure. The lower part, consisting of the arm, joint, and gripping section, is used during nasal surgeries. To prevent complications that may occur during concha lateralization, 5 Improved, single-step implementation, effective, with minimal destructive potential. This relates to the concha lateralization instrument. The use of this method alone, The prevailing opinion is that it does not provide sufficient effect. The disadvantage of this technique is that the concha... It usually returns to its original position. Also, in this technique, the concha There is no step that can reduce its magnitude. 10 b. Submucosal (under the mucosa) tissue resection (cutting): The inferior turbinate There are a number of methods used to reduce submucosal tissue. These Reduction is achieved either by directly cutting the tissue or by creating submucosal damage. It uses various thermal techniques. Submucosal fibrosis occurs after the damage created, and Contraction (shrinking) occurs. Depending on these changes, the turbinates contract 15 times. The vascular structures within it become blocked, and the erectile properties of the submucosal tissue are affected. a decrease occurs. - Submucosal electrocautery: To create submucosal thermal damage. Monopolar or bipolar electrocautery can be used. The procedure can be local or generalized. It can be performed under anesthesia. Depending on the surgeon's preference, the electrocautery used can be 20... Power, number of strokes, and stroke duration may vary. Electrocautery In this approach, an electric current is applied to heat a metal tip. The electrocautery tip reaches temperatures of up to 800°C during the procedure. It can reach [the area]. The hot electrode burns and destroys the tissue it is in. This technique, even when performed submucosaically and at low voltage, results in a 25... It has been reported that there is a high probability of damage to the surface mucosa. Apart from that, the literature indicates that the effects of this technique are short-lived and reversible. It is reported. - Submucosal radiofrequency ablation: In this method, the targeted tissue is treated. A high-frequency current is transmitted. This current mobilizes the ions in the medium. Ion 30 Due to the friction generated by the movement, heat is released. This heat is maximum It reaches 85-90 degrees and causes the desired submucosal thermal damage in the turbinates. It creates a much higher heat output compared to electrocautery. It is low. However, under the influence of various variables, mucosal It has also been reported to lead to the disruption of its integrity (user, technical, concha 35). 3 (volume, etc.). Post-procedure nasal congestion symptoms may persist for 3-6 months. It is reported that it has declined. - Submucosal cryotherapy: In cryotherapy, an instrument called a cryoprobe is inserted into the turbinates. This device is used to reduce the temperature of the target tissue from -12 to -85 degrees. The blood level drops. Intracellular ice crystals form, and tissue nutrition is impaired. This 5 This allows tissue ablation to occur. In this technique, mucosal damage is usually minimal. It is inevitable. - Submucosal turbinate resection with microdebrider (motorized devices): Thermal In a manner similar to these techniques, microdebridement of submucosal erectile tissue It is based on the principle of resecting with a device. A scalpel is used to resect the tip of the inferior turbinate. An incision is made and resection is performed in the submucosal plane. The procedure requires care and attention. It requires experience. Mucosal tearing or vascular injury may occur during the procedure. Complications such as bleeding due to injury may occur. c. Inferior turbinate resection: This is a surgically performed procedure. An incision is made at the tip of the concha, and the mucosa on both sides of the inferior concha bone is elevated. The bone structure is then cut and removed. Recently, an ultrasonic device With the help of, the inferior turbinate is emulsified using the same method. A method by which it is removed has been described. d. Techniques that sacrifice the mucosa: - Partial turbinate resection: A 1.5–2 cm section of the anterior portion of the inferior turbinate is removed. It is the complete surgical removal of a portion of the tissue. - Concha resection with argon plasma or laser: For this purpose, argon plasma is used. Carbon dioxide lasers, KTP lasers, and Nd:YAG lasers are used. With these methods, resection of the superficial mucosa, partial or total resection of the turbinate It is feasible. 25 e. Total turbinate resection: Total turbinate resection: Using scissors, the nose is cut open. completely excising the concha bone and concha soft tissue attached to the wall It is the preferred method due to its serious early and late complications. It is not being done. In conclusion, many techniques have been proposed for reducing enlarged inferior turbinates, however, There is no consensus on which technique is optimal. Some techniques... While some techniques fail to provide sufficient reduction in size, others achieve reduction during the process. undesirable damage to the outer mucosal surface that needs to be protected This leads to the occurrence of complications. 35 4 2) Hypertrophy of the Uvula and Soft Palate: a. Radiofrequency ablation: To specific areas of the uvula (small tongue) and soft palate. by applying radiofrequency energy and creating thermal damage, and this created damage... Shrinkage, volume loss, and hardening due to submucosal thermal damage 5 It is a method based on the principle of generation. Depending on the energy given. Insufficient reduction or hardening may occur, in which case the soft palate The sagging and elongation of the uvula may persist. In some cases, however, Complications such as mucosal and muscle damage, necrosis, and perforation may be observed. b. Placement of implants in the soft palate (pillar implant): Local or general 10 By placing several implants in the soft palate under anesthesia, the palate aiming to stiffen its structure and reduce its vibration during snoring It is a method. Its use is recommended in obstructive sleep apnea syndrome. It is not being done. c. Uvulectomy (Surgical removal of the uvula): Early and late stages 15 It has complications. Early symptoms include pain, bleeding, and difficulty swallowing. This can be observed. In the long term, nasal voice deterioration and voice resonance changes may occur. Complications such as aspiration of liquid foods into the nasopharynx may be observed. d. Uvulopalatoplasty and uvulopalatopharyngoplasty: The uvula, soft palate, and a part of the soft palate part of it, even the tonsils and the anterior and posterior folds of the tonsils, surgically removed 20 It involves cutting and suturing procedures. Early and late complications related to anesthesia and surgery. It has complications. In conclusion, due to the negative aspects described above and the current solutions, the subject matter... Due to its shortcomings, an improvement in the relevant technical field is necessary. 25 It has been observed. Purpose of the Invention The invention relates to mucosal structures of the inferior turbinates, uvula, soft palate, and soft palate folds. It is based on the principle of placing engineered nitinol strands in six planes. For this purpose The invention consists of a motorized unit containing a spiral needle tip, control buttons for this unit, and nitinol. an applicator containing an activation unit and a length suitable for the target tissue It uses spiral-shaped nitinol threads produced in various widths. A spiral carrier Nitinol thread, which is placed into the tissue with a needle and selected in a size suitable for the target tissue, is heated to 35°C. After activation, it becomes a smaller spiral in its memory. transformation and thus three-dimensional formation of soft tissues obstructing the upper airway The aim is to provide volumetric reduction in real time. Thanks to this invention, large turbinates that obstruct the nasal passages can be reduced in size, and enlarged and 5 The sagging uvula can be both reduced in size and shortened, as can the sagging soft palate. the palate, which is enlarged and sagging, can be pulled upwards towards the hard palate. The folds will be shortened and tightened, and the airway patency at the pharyngeal level will be maintained during sleep. This invention will be able to keep the skin open even during local and general anesthesia. It can be used under, and currently used in brain and heart vessels, 10 Because it is made of nitinol, the raw material for stents, there is a biocompatibility issue. will not survive. The invention addresses nasal congestion, simple snoring, and sleep-related breathing problems. It is designed for use in the surgical treatment of disorders (hypopnea and apnea). The device in question, which is the subject of the invention, will be manufactured using 'nitinol', also known as 'memory metal'. spiral-shaped metal, designed in sizes suitable for the surgical area to be treated. It will use wires. As is known, objects produced using nitinol, even if their shapes are changed... Even when they reach their memory temperature values, within milliseconds, they return to their original state of manufacture. They take on their current forms. Thanks to the device, this can be done in the office and under local anesthesia. Following a short surgical procedure, the patient will be able to return to daily activities within 20 days. It will be able to resume. Apart from the nitinol wires used as consumables, the device;  The motor, located inside the device housing, provides the drive.  The motor drive is connected to the motor axle 25, which is attached to the end of the device body. by taking in through it, it can move back and forth within the tissue by rotating, inside it Spiral-tipped nitinol threads release a spiral-shaped fiber into the tissue during movement. needle,  The backward movement of the spiral-tipped needle, located inside the spiral-tipped needle. During this process, the nitinol thread deposited into the tissue maintains its current position for 30 days. Nitinol inhibitor, which prevents it from coming back up.  Activated by a heating button on the device body, the nitinol filament is further... By obtaining a predetermined memory form, it works in 3D on the target tissue. to ensure it shrinks in a way that will allow for volumetric reduction The heater that heats the tip of the spiral-tipped needle, 35 6  A battery located inside the device housing provides energy for the motor and heater. will include. The structural and characteristic features and all the advantages of the invention are given in the figures below. Thanks to the detailed explanation written with references to these figures, 5 is clearer. It will be understood. Explanation of the Figures Figure 1 shows schematic and cross-sectional views of the device in question from different angles. 10 It shows. The drawings do not necessarily need to be scaled and are useful for understanding the invention. Unnecessary details may have been omitted. Explanation of Part References 1. Wireless charging coil 2. Device body cover 3. Device housing 20 4. Spiral-tipped needle 5. Engine 6. Battery 7th Circuit 8. Engine indicator 25 9. Engine axle 10. Nitinol filament 11. LED light 12. Charging socket 13. Charging unit input holes 30 14. Charging unit 15. Wireless charging unit 16. Nitinol inhibitor 17. Heater indicator 18. Motor button 35 7 19. Heater button 20. Needle-motor axis connection point Detailed Description of the Invention In this detailed explanation, the preferred configurations of the invention are not merely for better understanding the subject. in order to facilitate understanding and without imposing any limiting effects It is explained. The invention involves both the inferior turbinate and the uvula, soft palate, and soft palate. It will provide three-dimensional volume reduction in the folds, preventing sagging and creating an airway. It will increase its transparency and achieve this effect in the submucosal plane, on the mucosal surface. It is a device that can act without damaging physiologically important structures. Figure 1 shows schematic and cross-sectional views of the device that is the subject of the invention from different angles. 15 Accordingly, the device to be used for the process, with its internal components, is provided. Thanks to the battery (6), the charging cable can be charged via the charging socket (12) and the charging port (2) is located on the cover. wirelessly through holes (13) charging unit (14) or wirelessly through wireless charging coil (1) It can be charged using the charging dock (15) and used wirelessly. Device; device body (3), body cover (2), spiral tip needle (4), needle-motor axis connection 20 point (20) and body (3) containing battery (6), motor (5), motor axle (9), It will consist of circuits (7) and a wireless charging coil (1). A heater on the main body (3) and motor indicators (17, 8), heater and motor buttons (19, 18) and LED light (11) will be found. The procedure will be performed by an Ear, Nose, and Throat specialist under local or general anesthesia. After picking up the device, the target tissue (concha, etc.) can be examined with direct vision or endoscopic examination. It provides access to the uvula, soft palate, etc. It contains nitinol strands (10) and nitinol The spiral-tipped needle (4) with a stopper (16) is activated by activating the motor button (18) and the tissue It will be advanced by rotating it to the desired depth inside. Nitinol strand (10) 30 When the target tissue to be treated is reached, the Ear, Nose, and Throat specialist presses the motor button. (18) by pressing again, the spiral-tipped needle (4) rotates in the opposite direction and comes back This will provide. Meanwhile, nitinol will be positioned inside the spiral-tipped needle (4). The spiral-shaped nitinol thread (10) left in the tissue thanks to the stopper (16) It will maintain its current position and cannot reverse. The physician, application 35 8 If it determines that the area is unsuitable, at this point, it will manually turn the device on and off. Turning it in the opposite direction, remove the spiral-tipped needle (4) and the nitinol thread (10) inside it from the field. It can remove it. If there are no complications, it is left inside the tissue. spiral-ended nitinol strand (10) that will be in close proximity or in contact with The tip of the needle (4) will be heated using the heating button (19) and thus the nitinol thread 5 (10) obtaining the previously determined memory form in 3D in the target tissue It will shrink in a way that will allow for volumetric reduction. Repeat application is required. If necessary, the spiral-tipped needle (4) is removed from the connection point (20) and nitinol is placed inside. The new spiral needle (4) with thread (10) will be replaced. In this way the device will be able to function again. It will be ready for use. 10 Working principle and operation of the motor (5) and heater to be included in the device configurations; positions, number of buttons (18, 19) and indicators (8, 17) and The shapes; properties of the nitinol filament (10) and the method of bringing it into memory form (heat or (electrically); the diameter, length, spiral angle etc. of the spiral-tipped needle (4) are adjusted as above 15 In addition to the specified features and configurations, minor and major changes are applied. This can be applied to the device design. No electrical current is introduced to the body during the procedure. will not be given. Nitinol, which will provide volumetric reduction during the procedure. The activation temperature of the filaments will be minimal. This occurs after nitinol activation. Volume reduction is irreversible and its effects may continue in the long term. 20

Claims

9 REQUESTS 1. In the treatment of pathologies that cause sleep-related breathing disorders. It is a device that will be used; its feature is:  The motor (5), which is located inside the device housing (3) and provides the drive, 5  The motor (5) drive, connected to the end part (3) of the device body, is connected to the motor axle. (9) by taking it and rotating it within the tissue, it can move back and forth. the nitinol filament (10) inside it spirals into the tissue during its movement Spiral-tipped needle (4),  Located inside the spiral-tipped needle (4), the spiral-tipped needle (4) is turned backwards 10 The nitinol thread (10) that is left inside the tissue during the movement Nitinol is a stopper that prevents it from moving backward by maintaining its position. (16),  Nitinol activated by a heater button (19) on the device body (3). by obtaining the previously determined memory form of the strand (10) 15 to achieve 3D volumetric reduction in the target tissue A heater that heats the tip of the spiral-tipped needle (4) to cause it to shrink,  Located inside the device housing (3), providing energy for the motor (5) and heater. a battery (6) It includes. 20 2. A device that complies with Claim 1 and has the following features; charging cable via charging socket (12), device charging unit (14) via the charging holes (13) located on the body cover (2) or charging via wireless charging coil (1) using wireless charging dock (15) It includes the aforementioned battery (6). 25 3. A device that conforms to Claim 1 and whose feature is a motor for switching the motor (5) on and off. It contains the button (18).

4. A device that complies with Claim 1 and whose feature is; LED 30 located at the end of the device body (3). It contains light (11).

5. A device that complies with Claim 1 and whose feature is; operating status of the motor (5) and heater. It includes indicators that show... 35

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