WO2020179941A1 - Implant palatin et système de stimulation électrique l'utilisant - Google Patents

Implant palatin et système de stimulation électrique l'utilisant Download PDF

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Publication number
WO2020179941A1
WO2020179941A1 PCT/KR2019/002492 KR2019002492W WO2020179941A1 WO 2020179941 A1 WO2020179941 A1 WO 2020179941A1 KR 2019002492 W KR2019002492 W KR 2019002492W WO 2020179941 A1 WO2020179941 A1 WO 2020179941A1
Authority
WO
WIPO (PCT)
Prior art keywords
control signal
palatal
user
implant
soft palate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2019/002492
Other languages
English (en)
Korean (ko)
Inventor
김정훈
김성준
서정민
윤승현
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SNU R&DB Foundation
Seoul National University Hospital
Original Assignee
Seoul National University R&DB Foundation
Seoul National University Hospital
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Seoul National University R&DB Foundation, Seoul National University Hospital filed Critical Seoul National University R&DB Foundation
Priority to PCT/KR2019/002492 priority Critical patent/WO2020179941A1/fr
Publication of WO2020179941A1 publication Critical patent/WO2020179941A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • 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
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings

Definitions

  • the present invention relates to a palatal implant and an electrical stimulation system using the same, and to a palatal implant that is implanted in the palate and soft palate of the human body to provide electrical stimulation while physically supporting the palate muscles, and to an electrical stimulation system using the same.
  • Snoring that occurs as the airway narrows as the muscles in the airway area relax and squeeze down during sleep, which interferes with normal sleep, accompanied by symptoms such as chronic fatigue, drowsiness, memory loss and depression, and if it lasts for a long time, sleep Apnea, hypoxia, cardiopulmonary disease, and sudden death can lead to rapid and accurate cause identification and treatment.
  • Surgical methods include nasal surgery, pharyngeal surgery, tongue reduction surgery, and head and neck skeletal surgery depending on the cause of snoring, but the surgical treatment is accompanied by physical loss such as resection and correction of related muscles, and the patient suffers from physical pain and fear. And you can feel the cost burden.
  • Non-surgical methods include an intraoral device and a positive pressure device, but the intraoral device is expensive because it must be customized according to the patient's oral structure and snoring cause.
  • the positive pressure device may feel uncomfortable in that it is necessary to wear a face mask during sleep and noise is generated, and a positive pressure device that provides appropriate pressure according to the patient's airway pressure and body structure through a positive pressure test can be purchased or rented. It can be cumbersome in that it must be used.
  • the oral device and the positive pressure device have low treatment efficiency in that the treatment effect differs greatly depending on the patient.
  • the problem to be solved by one embodiment of the present invention is to provide a palatal implant that is implanted in the palatal muscle to provide electrical stimulation while physically supporting the soft palate.
  • the problem to be solved by one embodiment of the present invention is a palatal implant that is implanted in the palatine muscle to provide electrical stimulation, a wearing device that transmits power and control signals to the palatal implant using a non-contact magnetic induction coupling method, and a short-range wireless communication.
  • an electrical stimulation system including a user terminal for controlling the wearing device.
  • an embodiment of the present invention provides a communication unit for receiving a stimulation control signal from an external device through a magnetic induction coupling method, a control unit for generating a current pulse based on the received stimulation control signal, and a current pulse. It includes an electrode array that provides stimulation based on the user's palatal and soft palate, and proposes a palatal implant that physically supports the palatal and soft palate.
  • the electrode array may be positioned in contact with the soft palate.
  • the communication unit and the control unit may be sealed with a biocompatible polymer.
  • it may further include a rectifier circuit for supplying power to the communication unit, the control unit and the electrode array by using the stimulation control signal.
  • an embodiment of the present invention is located in the mouth of the user, receives a first control signal transmitted from the user terminal through the first communication network, and a second control signal corresponding to the first control signal
  • a wearable device that generates and transmits it through a second communication network, and a palate that is located on the palate muscle of the user, receives a second control signal through the second communication network, and generates and outputs a current pulse corresponding to the second control signal.
  • an electrical stimulation system including an implant.
  • the first communication network may use short-range wireless communication.
  • the second communication network may use a magnetic inductive coupling method.
  • the wearing device may include a sensor unit that detects a user's biological state, and may generate and transmit a second control signal corresponding to the first control signal according to the detected biological state.
  • first control signal and the second control signal may include the intensity, frequency, and duration of the current pulse.
  • the palatal implant may include an electrode array positioned on the user's soft palate, and may provide stimulation by outputting current pulses through the electrode array.
  • the palatal implant is located over the user's palatal and soft palate, and can physically support the palatal and soft palate.
  • the present invention it is possible to alleviate symptoms of snoring and sleep apnea by preventing the user from obstructing the upper respiratory tract.
  • FIG. 1 shows the configuration of an electrical stimulation system using a palatal implant according to an embodiment of the present invention.
  • FIG. 2 shows a detailed configuration of the user terminal and the wearing device of FIG. 1.
  • FIG. 3 shows a detailed configuration of the palatal implant of FIG. 1.
  • FIG. 4 shows a method of providing electrical stimulation using the electrical stimulation system of FIG. 1.
  • the'palat' refers to the boundary between the nasal cavity and the oral cavity as the upper wall of the oral cavity, and includes the hard palate in the front part and the soft palate in the back part of the palate.
  • the'palatal muscle' refers to a muscle involved in the movement of the palate.
  • 'user' and'patient' refer to a subject for electrical stimulation treatment wearing a palatal implant and a wearing device.
  • FIG. 1 shows the configuration of an electrical stimulation system using a palatal implant according to an embodiment of the present invention.
  • the electrical stimulation system 10 of FIG. 1 is a user terminal 100 that transmits a first control signal to the wearing device 200 according to a user command from outside the body, and a second control signal is located in the living body and is sent to the palatal implant 300. It includes a wearing device 200 for transmitting, and a palatal implant 300 for outputting a minute current pulse from the palatal muscle.
  • FIGS. 2 and 3 the user terminal 100, the wearing device 200, and the palatal implant 300 will be described in detail through FIGS. 2 and 3.
  • FIG. 2 shows a detailed configuration of the user terminal and the wearing device of FIG. 1.
  • the user terminal 100 is located outside the living body, and includes a user interface unit 110, a first communication unit 120, and a storage unit 130.
  • the user terminal 100 may be implemented as a smartphone, a tablet PC, a wearable terminal, and the like, and an application for controlling the wearable device 200 may be installed.
  • the user interface unit 110 receives a user's command and outputs a control result and a breathing state. Specifically, a first control signal corresponding to a value input through a user's voice or switch manipulation is generated.
  • the first control signal includes a stimulation parameter including intensity, frequency, duration, short/multi-channel, bipolar output, etc. of the current pulse, and a treatment step corresponding to the snoring symptom of the patient.
  • the first communication unit 120 transmits a first control signal corresponding to a user command to the wearing device 200 through short-range wireless communication.
  • short-range wireless communication includes Bluetooth, Zigbee, Wi-Fi, and the like.
  • the storage unit 130 stores stimulation parameters for each treatment step. Specifically, the storage unit 130 transmits a stimulation parameter corresponding to the treatment step received from the user interface unit 110 to the wearing device 200 through the first communication unit 120. For example, the storage unit 130 may divide the patient's symptoms into four stages of simple snoring, upper respiratory resistance syndrome, low breathing snoring, and sleep apnea, and store stimulation parameters corresponding to each stage.
  • the wearing device 200 is located in the oral cavity, and includes a sensor unit 210, a second communication unit 220, a first control unit 230, a third communication unit 240, and a battery unit 250. Include.
  • the wearing device 200 is implemented in a form that can be inserted into the oral cavity or coupled to a tooth, and can be separated from the oral cavity or the tooth.
  • the wearing device 200 may be implemented as a mouthpiece corresponding to the user's oral structure, so that the user may wear it on the maxillary teeth, the mandibular teeth, or both the maxillary and the mandibular teeth. .
  • the upper and lower jaws are physically supported during sleep to prevent the tongue, uvula, and tonsils from being pushed inward, thereby securing airways.
  • the sensor unit 210 includes one or more sensors and detects a user's biological state.
  • the wearable device 200, the palatal implant 300, or a separate device is implemented and located inside and outside the oral cavity, and can sense the user's sound, vibration, heart rate, movement, and body temperature.
  • the second communication unit 220 performs short-range wireless communication with the user terminal 100 and receives a first control signal transmitted from the user terminal 100.
  • the first control unit 230 modulates and amplifies the first control signal received through the second communication unit 220.
  • a second control signal corresponding to the first control signal is generated based on the detection result of the sensor unit 210. For example, when it is determined that the patient is in a deep sleep state as a result of detection by the sensor unit 210, a second control signal having increased stimulation parameters of the first control signal may be generated.
  • the third communication unit 240 transmits the second control signal to the palatal implant 300 through a magnetic induction coupling method.
  • the third communication unit 240 is implemented as a coil, and may be manufactured by, for example, a conductive wire in a printable form on a printed circuit board (PCB) or a micro electro-mechanical systems (MEMS) process.
  • the third communication unit 240 receives the confirmation signal transmitted from the palatal implant 300, and transmits it to the user terminal through the second communication unit 220.
  • the battery unit 250 supplies power to each of the sensor unit 210, the second communication unit 220, the first control unit 230, and the third communication unit 240, and external charging through the third communication unit 240
  • the device can be charged in a magnetic inductive coupling method.
  • the wearing device 200 of FIG. 2 may be sealed with a biocompatible polymer to prevent irritation to oral tissues (eg, teeth, gums, tongue, etc.) and minimize foreign body sensation when worn by a patient.
  • biocompatible polymers include parylene, polydimethylsiloxane (PDMS), polyimid, liquid crystal polymer (LCP), and the like.
  • FIG. 3 shows a detailed configuration of the palatal implant of FIG. 1.
  • the palatal implant 300 is implanted in the palatal muscle to provide electrical stimulation to the soft palate while physically supporting the palatal muscle, and a fourth communication unit 310, a second control unit 320, and an electrode array ( 330).
  • the fourth communication unit 310, the second control unit 320, and the electrode array 330 are electrically connected.
  • the palatal implant 300 may be implemented in a circular or polygonal column shape positioned in a partial region of the hard palate and the entire region of the study palate.
  • the fourth communication unit 310 receives a second control signal transmitted from the wearing device 200 through a magnetic induction coupling method.
  • a confirmation signal indicating whether the palatal implant 300 operates normally is transmitted to the wearing device 200.
  • the fourth communication unit 310 receives a digital signal (a second control signal) placed on a carrier wave in a sine or cosine form from the wearing device 200 through a magnetic induction coupling method, and receives Power is supplied to the second control unit 320 and the electrode array 330 by generating power through a rectifying circuit based on the digital signal (second control signal).
  • the fourth communication unit 310 may be implemented as a coil, and may be manufactured by, for example, a printed circuit board (PCB) or a micro electro-mechanical systems (MEMS) process.
  • PCB printed circuit board
  • MEMS micro electro-mechanical systems
  • the second control unit 320 generates a biphasic current pulse based on the second control signal received from the fourth communication unit 310 and outputs it through the electrode array 330.
  • the second control unit 320 may be implemented in the form of a chip in which a plurality of transistors are integrated.
  • the electrode array 330 provides electrical stimulation to the palate muscles through the output of current pulses.
  • the electrode array 330 is implemented with a plurality of electrodes including metal materials such as gold (Au), iridium (Ir), and platinum (Pt).
  • the palatal implant 300 of FIG. 3 is implemented in a small size and is implanted in the palatal muscle, and the fourth communication unit 310 and the second control unit 320 are located on the hard palate, and the electrode array 330 is located on the soft palate.
  • the biocompatible polymer includes at least one of parylene, polydimethylsiloxane (PDMS), polyimid, or liquid crystal polymer (LCP). Accordingly, it is possible to prevent narrowing of the upper airway due to relaxation of the soft palate and the uvula by physically supporting the palate and soft palate muscles.
  • the fourth communication unit 310 and the second control unit 320 are sealed with a biocompatible polymer so that they do not come into direct contact with the palatal muscles, and the electrode array 330 directly contacts the soft palate muscles. . For this reason, the palatal implant 300 can be implanted for a long period of time and side effects such as immune rejection can be prevented.
  • FIG. 4 shows a method of providing electrical stimulation using the electrical stimulation system of FIG. 1.
  • the user terminal 100 receives a control value input through the user interface unit 110 (S11), and wears a first control signal corresponding to the control value received at S11 through the first communication unit 120 It transmits to the device 200 (S12).
  • the wearing device 200 receives the first control signal transmitted from S12 through the second communication unit 220 (S13).
  • the user's sleep state is sensed through the detection result of the sensor unit 210 (S14), and a second control signal corresponding to the sleep state detected in S14 is generated through the first control unit 230 to generate a third communication unit.
  • the second control signal may be generated by controlling the strength of the stimulation parameter included in the first control signal received in S13 according to the sleep state of the patient.
  • the palatal implant 300 receives the second control signal transmitted in S15 through the fourth communication unit 310 (S16). Thereafter, power is supplied based on the second control signal received in S16 through the second control unit 320 and a current pulse corresponding to the stimulation parameter is generated (S17). Thereafter, the current pulse generated in S17 is output through the electrode array 330 (S18).
  • a palatal implant and a wearing device may be used to physically support the patient's palate, uvula, tongue, and tonsils, while providing stimulation by microcurrent pulses to contract the soft palate muscles. Accordingly, snoring and sleep apnea symptoms can be improved by preventing airway obstruction due to the uvula, tongue and tonsils.
  • an electrical stimulation system can be used without time and place restrictions.

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  • Health & Medical Sciences (AREA)
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Abstract

La présente invention concerne un implant palatin et un système de stimulation électrique l'utilisant. Un implant palatin selon un mode de réalisation de la présente invention comprend : une unité de communication destinée à recevoir un signal de commande de stimulation provenant d'un dispositif externe par l'intermédiaire d'un schéma de couplage par induction magnétique ; une unité de commande destinée à générer une impulsion de courant sur la base du signal de commande de stimulation reçu ; et un réseau d'électrodes destiné à fournir une impulsion sur la base de l'impulsion de courant, l'implant palatin étant positionné sur la voûte palatine et le voile du palais et soutenant physiquement la voûte palatine et le voile du palais.
PCT/KR2019/002492 2019-03-05 2019-03-05 Implant palatin et système de stimulation électrique l'utilisant Ceased WO2020179941A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/KR2019/002492 WO2020179941A1 (fr) 2019-03-05 2019-03-05 Implant palatin et système de stimulation électrique l'utilisant

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Application Number Priority Date Filing Date Title
PCT/KR2019/002492 WO2020179941A1 (fr) 2019-03-05 2019-03-05 Implant palatin et système de stimulation électrique l'utilisant

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WO2020179941A1 true WO2020179941A1 (fr) 2020-09-10

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113951827A (zh) * 2021-10-27 2022-01-21 上海联影智融医疗科技有限公司 植入物的控制装置、方法、植入物以及存储介质

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080103545A1 (en) * 2006-10-13 2008-05-01 Apnex Medical, Inc. Obstructive sleep apnea treatment devices, systems and methods
US20090173352A1 (en) * 2007-11-01 2009-07-09 Pavad Medical On-off implant for supporting the airway
KR101303438B1 (ko) * 2011-09-14 2013-09-05 서울대학교산학협력단 코골이 및 수면 무호흡 치료 장치
KR20150112923A (ko) * 2012-07-26 2015-10-07 아디 매쉬아취 임플란트 디바이스와 외부 디바이스 간의 내부 공진 매칭
KR20190031757A (ko) * 2017-09-18 2019-03-27 서울대학교산학협력단 구개 임플란트 및 이를 이용한 전기 자극 시스템

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080103545A1 (en) * 2006-10-13 2008-05-01 Apnex Medical, Inc. Obstructive sleep apnea treatment devices, systems and methods
US20090173352A1 (en) * 2007-11-01 2009-07-09 Pavad Medical On-off implant for supporting the airway
KR101303438B1 (ko) * 2011-09-14 2013-09-05 서울대학교산학협력단 코골이 및 수면 무호흡 치료 장치
KR20150112923A (ko) * 2012-07-26 2015-10-07 아디 매쉬아취 임플란트 디바이스와 외부 디바이스 간의 내부 공진 매칭
KR20190031757A (ko) * 2017-09-18 2019-03-27 서울대학교산학협력단 구개 임플란트 및 이를 이용한 전기 자극 시스템

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113951827A (zh) * 2021-10-27 2022-01-21 上海联影智融医疗科技有限公司 植入物的控制装置、方法、植入物以及存储介质

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