WO2020179941A1

WO2020179941A1 - Palatal implant and electrical stimulation system using same

Info

Publication number: WO2020179941A1
Application number: PCT/KR2019/002492
Authority: WO
Inventors: 김정훈; 김성준; 서정민; 윤승현
Original assignee: 서울대학교산학협력단; 서울대학교병원
Priority date: 2019-03-05
Filing date: 2019-03-05
Publication date: 2020-09-10

Abstract

The present invention relates to a palatal implant and an electrical stimulation system using same. A palatal implant according to an embodiment of the present invention comprises: a communication unit for receiving a stimulation control signal from an external device through a magnetic induction coupling scheme; a control unit for generating a current pulse on the basis of the received stimulation control signal; and an electrode array for providing an impulse on the basis of the current pulse, wherein the palatal implant is positioned over the hard palate and the soft palate and physically supports the hard palate and the soft palate.

Description

Palate implant and electrical stimulation system using the same

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.

Conventional snoring treatment methods are largely divided into surgical methods and non-surgical methods. 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. In addition, 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. In addition, 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. Thus, it is to provide an electrical stimulation system including a user terminal for controlling the wearing device.

In addition to the above problems, the embodiments according to the present invention may be used to achieve other tasks not specifically mentioned.

In order to solve the above problem, 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.

Here, the electrode array may be positioned in contact with the soft palate.

In addition, the communication unit and the control unit may be sealed with a biocompatible polymer.

In addition, 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.

In order to solve the above problem, 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. We propose an electrical stimulation system including an implant.

Here, the first communication network may use short-range wireless communication.

In addition, the second communication network may use a magnetic inductive coupling method.

In addition, 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.

In addition, the first control signal and the second control signal may include the intensity, frequency, and duration of the current pulse.

In addition, 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.

In addition, the palatal implant is located over the user's palatal and soft palate, and can physically support the palatal and soft palate.

According to an embodiment of the present invention, it is possible to alleviate symptoms of snoring and sleep apnea by preventing the user from obstructing the upper respiratory tract. In addition, it is possible to provide a snoring treatment device that is easy to use and adapts and has a high therapeutic effect while reducing the cost burden of the patient compared to conventional surgical treatment.

1 shows the configuration of an electrical stimulation system using a palatal implant according to an embodiment of the present invention.

2 shows a detailed configuration of the user terminal and the wearing device of FIG. 1.

3 shows a detailed configuration of the palatal implant of FIG. 1.

4 shows a method of providing electrical stimulation using the electrical stimulation system of FIG. 1.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those of ordinary skill in the art may easily implement the present invention. The present invention may be implemented in various different forms, and is not limited to the embodiments described herein. In the drawings, parts irrelevant to the description are omitted in order to clearly describe the present invention, and the same reference numerals are used for the same or similar components throughout the specification. In addition, in the case of a well-known technology, a detailed description thereof will be omitted.

In the present specification, when a part "includes" a certain component, it means that other components may be further included rather than excluding other components unless otherwise stated. In addition, terms such as "... unit" and "... module" described in the specification mean a unit that processes at least one function or operation, which may be implemented by hardware or software or a combination of hardware and software.

In the present specification, 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. In addition, the'palatal muscle' refers to a muscle involved in the movement of the palate.

In the present specification,'user' and'patient' refer to a subject for electrical stimulation treatment wearing a palatal implant and a wearing device.

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.

Hereinafter, the user terminal 100, the wearing device 200, and the palatal implant 300 will be described in detail through FIGS. 2 and 3.

Referring to FIG. 2, 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. For example, 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. Here, 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. For example, 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.

2, 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. In this case, 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. For example, 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. . At this time, when the mouthpiece is worn on the upper and lower 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. Specifically, 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. In addition, 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. Here, 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. In addition, 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. For example, biocompatible polymers include parylene, polydimethylsiloxane (PDMS), polyimid, liquid crystal polymer (LCP), and the like.

3 shows a detailed configuration of the palatal implant of FIG. 1.

3, 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). In this case, the fourth communication unit 310, the second control unit 320, and the electrode array 330 are electrically connected. For example, 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. In addition, a confirmation signal indicating whether the palatal implant 300 operates normally is transmitted to the wearing device 200. Specifically, 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). In addition, 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.

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. For example, 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. Specifically, 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. For example, 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.

In the palatal implant 300 of FIG. 3, 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.

First, 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). In addition, 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. Transmitted to the palatal implant 300 through (240) (S15). Specifically, 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).

According to an embodiment of the present invention, 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.

According to an embodiment of the present invention, it is possible to maximize the therapeutic effect by controlling the intensity of the electrical stimulation according to the sleeping state of the patient.

According to an embodiment of the present invention, since the palatal implant implanted in the palatal muscle is controlled using a portable user terminal and an intraoral wear device, an electrical stimulation system can be used without time and place restrictions.

Although the embodiments of the present invention have been described in detail above, the scope of the present invention is not limited thereto, and a form modified and improved by a person of ordinary skill in the field to which the present invention belongs is also the right of the present invention. Belongs to the range.

[Explanation of code]

10: electrical stimulation system

100: user terminal

110: user interface unit

120: first communication unit

130: storage unit

200: wearing device

210: sensor unit

220: second communication unit

230: first control unit

240: 3rd communication unit

250: battery part

300: palatal implant

310: 4th communication department

320: second control unit

330: electrode array

Claims

A communication unit that receives a stimulation control signal from an external device through a magnetic induction coupling method,

A control unit that generates a current pulse based on the received stimulation control signal, and

Electrode array providing stimulation based on the current pulse

Including,

A palatal implant positioned over the user's palatal and soft palate, and physically supporting the palatal and soft palate.
In claim 1,

The electrode array is placed in contact with the soft palate implant.
In claim 1,

The communication unit and the control unit are sealed with a biocompatible polymer.
In claim 1,

A palatal implant further comprising a rectifier circuit for supplying power to the communication unit, the control unit, and the electrode array using the stimulation control signal.
A wearable device located in the user's oral cavity, receiving a first control signal transmitted from a user terminal through a first communication network, generating a second control signal corresponding to the first control signal, and transmitting it through a second communication network, And

A palatal implant located on the palate muscle of the user, receiving the second control signal through the second communication network, and generating and outputting a current pulse corresponding to the second control signal

Electrical stimulation system comprising a.
In clause 5,

The first communication network is an electrical stimulation system using short-range wireless communication.
In clause 5,

The second communication network is an electrical stimulation system using a magnetic induction coupling method.
In clause 5,

The wearing device includes a sensor unit that detects the user's biological state, and generates and transmits the second control signal corresponding to the first control signal according to the detected biological state.
In clause 5,

The first control signal and the second control signal include an intensity, frequency, and duration of the current pulse.
In clause 5,

The palatal implant includes an electrode array positioned on the soft palate of the user, and outputs the current pulse through the electrode array to provide stimulation.
In clause 5,

The palatal implant is located over the user's palatal and soft palate, and the electrical stimulation system physically supports the palatal and soft palate.