WO2019088582A1

WO2019088582A1 - Multidirectionally adjustable apparatus for treating obstructive sleep apnea

Info

Publication number: WO2019088582A1
Application number: PCT/KR2018/012788
Authority: WO
Inventors: 김상욱; 김세현
Original assignee: 경상대학교산학협력단
Priority date: 2017-11-01
Filing date: 2018-10-26
Publication date: 2019-05-09
Also published as: KR102175808B1; KR20190049502A

Abstract

Provided is an apparatus for treating obstructive sleep apnea. The apparatus for treating obstructive sleep apnea, according to an embodiment of the present application, comprises: a handle (100); a proximal portion (200) connected to the handle (100) and extending from the handle (100); a distal portion (300) hingedly and rotatably connected to the proximal portion (200) by a predetermined first angle, and extending from one end of the proximal portion (200); and a plurality of electrode needles (410, 420, 430) mounted on the distal portion (300).

Description

Multidirectionally adjustable obstructive sleep apnea

The present application relates to a multi-directionally adjustable obstructive sleep apnea therapy apparatus.

In general, there are three types of sleep apnea. Obstructive sleep apnea is the most common form, involving reversible tissue closure of the upper respiratory tract. The other is central apnea, which is very rare and results from a problem with the central nervous system that activates the respiratory mechanism. Finally, mixed aphasia is a case of occlusion and central apnea occurring together in sequence.

Referring to Figs. 2 and 3, the obstructive sleep apnea will be described in detail.

During sleeping, the breathing air passes through the narrowed throat, causing the breathing air to interfere, causing the respiratory organ itself to vibrate as a vibration plate. When a person breathe, the air passes through flexible structures such as the palate, the umbra, the tongue, and the tongue, and in the daytime, the surrounding muscles help them maintain their position so they do not block the air passage. However, during sleep, the muscles loosen and sag, so that the air passage narrows in part, and when the air passes through this part, the soft parts around the mouth are vibrated to make the snoring sound.

This anatomical cause of obstructive sleep apnea will be described with reference to FIGS. 1 and 2. FIG.

FIG. 2 is an anatomical structure diagram of a normal head or an obstructive sleep apnea patient in a waking state. FIG. 3 is a view showing a state where obstructive sleep apnea occurs due to narrowing of the pharynx Anatomical structure.

The palate 11 surrounds the hard bone in the mouth of the mouth in the oral cavity 10 and has a soft muscle 12 joined to the end of the palate 11.

The two passages separated from each other by the both nostrils 13 meet with each other in the nasal cavity 14 through the nasal cavity 14 and the elevation 15, the middle degree 16 and the lower degree 17. The iris 18 is located in front of the mouthpiece 18 and the iris 19 is positioned below the iris 18 and the hypopharynx 21 is located below the mouth of the mouth 19, The oropharynx (19) and hypopharynx (21) are both corrugated mucous membranes. Then, the lower part of the hypopharynx 21 is separated into the esophagus 22 and the organs 23.

The air that has entered the nasal cavity 14 through the nostrils 13 enters the organs 23 through the inhaler ports 18 and the hypopharynx 21. At this time, Obstructive sleep apnea occurs when the airway is blocked by the swelling of Sulgeun (24), oropharyngeal (19) and hypopharyngeal (21) tissues.

Obstructive Sleep Apnea While the patient is sleeping, the muscles constituting the study dog (12) are relaxed, so that the person is lying upright and hangs toward the rear wall of the pharynx to block the oropharynx (19).

In obstructive sleep apnea (OSA), the occlusion (A1-A2) occlusion is terminated with a brief sleep. At the breaking point, prayer opens again and resumes breathing. In severe cases, this condition occurs every minute during sleep and leads to repetitive sleep disturbances. In addition, repeated interruptions in normal breathing can lead to a decrease in oxygen saturation in the blood. Excessive obesity in the neck is a common cause of OSA. OSA is closely related to obesity-related measures such as neck thickness, weight, and body-mass index (BMI). Men's shirt size is a useful predictor, so if the collar size of the shirt is greater than about 42 cm, you should suspect the OSA. Other causes of this condition include medical problems such as hypothyroidism or tonsillitis. This symptom is also commonly found in patients with retrognathia. It is here that patients with physical characteristics of East Asian people are more likely to have sleep apnea even though they are not overweight. The most common symptom of OSA is drowsiness, and many patients complain that they do not sleep when they sleep. Sleep disturbance can cause poor concentration, short-term memory deterioration, and increased sensitivity. OSA is usually accompanied by snoring and causes temporary respiratory arrest. Resumption of breathing is usually done by breathing off or breathing strongly. Severe OSA patients who stop breathing once every two minutes, or more than 30 times an hour, are at risk for other diseases such as ischemic heart disease, hypertension, and insulin resistance.

Sleep apnea can be treated by surgical and respiratory assist devices. The most effective and effective method is to use continuous positive airway pressure (CPAP). In this method, a mask is put on the face of a nose or mouth to continuously blow air into the upper part while sleeping (see Fig. 1).

However, since the mask is tightly attached to the nose, it is inconvenient, and the use rate (patient compliance, compliance) is lowered due to the heterogeneity of the air pressure. .

(Patent Document 1) International Publication WO 2010/060097

(Patent Document 2) Korean Patent Registration No. 1601067

(Patent Document 3) International Publication No. WO 2014/012032

This application is contrived to solve the above problems. Particularly, there is no inconvenience to wear such as a conventional continuous airway pressure gauge, the distal part can be hinged at various angles with respect to the proximal part, and the longitudinal axis of the proximal part can be rotated around the rotation axis, We want to provide sleep apnea therapy.

One embodiment of the present application for solving the above problems is directed to a handle 100 having a proximal portion 200 connected to the handle 100 and extending from the handle 100, A distal portion 300 extending from one end of the proximal portion 200 and hingably connected to the proximal portion 300 by a first angle relative to the distal portion 300 and a plurality of electrode needles 410, The present invention provides an obstructive sleep apnea therapy apparatus.

In one embodiment, the distal portion 300 may be rotatable 360 degrees about the longitudinal axis of the proximal portion 200 in connection with the proximal portion 200.

In one embodiment, the plurality of

electrode needles

410, 420, and 430 may be hingedly rotatable with respect to the distal portion 300 by a predetermined second angle.

In one embodiment, the plurality of

electrode needles

410, 420, and 430 may be slidably disposed between a first position protruding from the distal portion 300 and a second position being embedded within the distal portion 300. In one embodiment, have.

The control unit 110 includes a power supply unit 111 for supplying power, an operation unit 112 for receiving an operation signal, a control unit 112 for generating a control signal in accordance with an operation signal input to the operation unit 112 And a driving unit 114 for driving the distal portion 300 and the plurality of

electrode needles

410, 420, and 430 according to a control signal generated by the control unit 113 and the control unit 113.

In one embodiment, the predetermined first angle may be between 90 degrees and 180 degrees.

In one embodiment, the predetermined second angle may be between 0 and 180 degrees.

In one embodiment, any one of the plurality of

electrode needles

410, 420, and 430 may be mounted on the distal portion 300 at equal distances from adjacent electrode needles.

In one embodiment, any one of the

electrode needles

410, 420, and 430 may be spaced apart from adjacent electrode needles and mounted to the distal portion 300.

In one embodiment, the plurality of

electrode needles

410, 420, and 430 irradiate a signal in an RF (Radio Frequency) region to an inserted portion, and an RF plasma may be generated by the signal.

The present application as described above has the following effects.

First, since the electrode needle is inserted in a region including the left side and the right side and the side wall of the patient so as to induce the fibrosis of the tissue in a direction in which the upper region is ensured by irradiating signals in the RF (Radio Frequency) region, Unlike the treatment using the airway pressure gauge, there is no inconvenience of wearing, and sleep apnea due to the obstruction can be effectively treated.

Second, unlike conventional needle-shaped probes, the distal portion can be hinged at various angles with respect to the proximal portion, and the proximal portion of the proximal portion can be rotated 360 degrees with the rotation axis in a predetermined angle hinge rotation state. This is possible.

Third, multiple electrode needles can be rotated at various angles with respect to the distal part so that it is possible to perform operations on a part where the conventional approach is difficult.

Fourth, the interval between the plurality of electrode needles is constant, and the interval is set to 5 mm to 15 mm so that even if the signal of the RF region is irradiated, the tissue does not fall into the necrosis and the tissue damage caused by the repeated operation on the same region is prevented .

Fifth, since the interval between the plurality of electrode needles can be adjusted, it is possible to perform more various types of operations than the case where the gap is fixed.

Sixth, because the treatment can be performed by inserting the electrode needle into the treatment site and irradiating the signal of the RF region, the procedure is relatively simple and can be quickly recovered.

FIG. 1 is a view showing a state in which airway is secured using a sustained-air pressure regulator in a conventional sleep apnea treatment method.

Figures 2 and 3 are cross-sectional views of the head showing the internal structure of the nose, mouth and throat portion of a person.

4 and 5 show a state in which the endoscope is inserted into the nasal cavity to observe the airway. FIG. 4 shows a state in which the airway is secured, and FIG. 5 shows a state in which the airway is closed in the direction of the rear wall of the pharynx Fig.

6 is a schematic perspective view for explaining an obstructive sleep apnea therapy apparatus according to an embodiment of the present application.

Fig. 7 is a block diagram for explaining the configuration of the control device 110. Fig.

Figures 8 and 9 illustrate the operation of the distal part 300. Figure 8 illustrates the hinge rotation of the distal part 300 with respect to the proximal part 200, And is rotated with the longitudinal axis of the proximal portion 200 as a rotation axis.

10 is a view for explaining operation (hinge rotation, thickness direction sliding, longitudinal sliding) of the distal end portion 300 of a plurality of electrode needles 410, 420, and 430.

11 is a view illustrating the treatment of obstructive sleep apnea by inserting an obstructive sleep apnea therapy apparatus according to an embodiment of the present application into a nasal cavity and inserting a plurality of electrode needles 410, 420, and 430 into a study dog.

Hereinafter, an obstructive sleep apnea therapy apparatus according to an embodiment of the present application will be described in detail with reference to the accompanying drawings.

6, an obstructive sleep apnea device 1000 according to an embodiment of the present application includes a handle 100, a proximal portion 200, a distal portion 300, and a plurality of electrode needles 410, 420, and 430 .

The handle 100 is a portion gripped by the operator's hand. The handle 100 may be provided in a cylindrical shape, but is not limited to any shape that is easily grasped by a hand of the practitioner and is easy to use. The handle 100 may be made of various materials in order to improve grip feeling. For example, a material of a cushion material may be used.

At both ends of the handle 100, stepped

portions

120 and 130 having a radius larger than the radius of the handle 100 are preferably formed. Accordingly, the obstructive sleep apnea apparatus 1000 can be prevented from being detached from the hands of the practitioner.

A control device 110 for controlling the obstructive sleep apnea apparatus 1000 is installed inside the handle 100. Alternatively, the control device 110 may be provided in a separate console form from the handle 100.

7, the control device 110 includes a power supply unit 111, an operation unit 112, a control unit 113, and a driving unit 114.

The power supply unit 111 is a part for supplying power for driving the obstructive sleep apnea treatment apparatus 1000.

The operation portion 112 is a portion for receiving an operation signal from a practitioner. The practitioner controls the rotation of the distal portion 300 and the plurality of electrode needles 410, 420 and 430 and the RF region of the plurality of electrode needles 410, 420 and 430 using the buttons provided on the handle 100 An operation signal such as a signal irradiation can be input.

The control unit 113 generates a different control signal in accordance with the operation signal input to the operation unit 112.

The driving unit 114 drives the distal portion 300 and the plurality of electrode needles 410, 420, and 430 according to a control signal generated from the control unit 113.

As described above, the operation of the obstructive sleep apnea apparatus 1000 is performed by the controller 110, and a specific operation process will be described later.

The proximal portion 200 is connected to the knob 100 and extends from the knob 100. The distal portion 300 is a portion that guides the distal portion 300 in order to approach the procedure site, and is preferably adjustable in length with respect to the handle 100. Since the distance from the oral cavity to the study dog or pharynx varies from person to person, the proximal part 200 is provided in a length-adjustable manner so that elaborate procedures are possible.

The proximal portion 200 serves as a bridge for mechanically and electrically connecting the handle 100 and the distal portion 300 and the surface of the proximal portion 200 is preferably covered with an insulative material.

The distal portion 300 is a portion extending from one end of the proximal portion 200. Is connected to the proximal portion 200 such that it is hingeably rotatable by a predetermined first angle relative to the proximal portion 200, wherein the predetermined first angle is preferably between 90 degrees and 180 degrees. When the predetermined first angle is 90 degrees, the distal portion 300 is an angle perpendicular to the proximal portion 200, and 180 degrees is a horizontal angle (see FIG. 8). The practitioner can adjust the angle of the proximal portion 200 of the distal portion 300 to position the distal portion 300 at the procedure site.

The distal portion 300 can also be rotated 360 degrees with the longitudinal axis of the proximal portion 200 as the rotational axis in a hinged rotation with respect to the proximal portion 200 (i.e., at any one of angles from 90 degrees to 180 degrees) .

The distal portion 300 may be hinged by a predetermined first angle relative to the proximal portion 200 and the longitudinal axis of the proximal portion 200 may be rotated 360 degrees with the rotational axis in a state of being positioned at any one of the predetermined first angles Therefore, the practitioner can easily position the distal portion 300 at the treatment site while adjusting the direction of the obstructive sleep apnea 1000 according to the treatment area.

The plurality of electrode needles 410, 420, and 430 irradiate a signal in an RF (Radio Frequency) region on a portion inserted and inserted into a treatment site. Here, three

electrode needles

410, 420, and 430 are provided as an example. However, the number of the electrode needles 410, 420, and 430 may be two or less and four or more.

An RF plasma is generated by the signal irradiated by the plurality of electrode needles 410, 420, and 430, absorbing a portion of the tissue to reduce the volume of the tissue, and at the same time, induce fibrosis in the wound recovery process to make the tissue tight . At this time, it is preferable that the plurality of electrode needles 410, 420, and 430 are inserted in a direction in which the upper end of the electrode needle 410 extends, that is,

The plurality of electrode needles 410, 420, 430 are connected to the distal portion 300 in a hinged rotatable manner by a predetermined second angle relative to the distal portion 300, wherein the predetermined second angle is preferably between 0 and 180 degrees Do. Thus, the practitioner can position the distal portion 300 proximate the treatment site and adjust the angle of the plurality of electrode needles 410, 420, 430 with respect to the distal portion 300 to be inserted into the treatment site.

Preferably, the plurality of electrode needles 410, 420, 430 are also slidable in the thickness direction of the distal portion 300 with respect to the distal portion 300. Specifically, the plurality of electrode needles 410, 420, and 430 slide between a first position protruding from the distal portion 300 and a second position being embedded in the distal portion 300. The plurality of electrode needles 410 , 420, and 430 may be protruded only when insertion is required.

Any one of the plurality of electrode needles 410, 420, and 430 may be provided at the distal portion 300 such that the electrode needle is equally spaced or spaced apart from adjacent electrode needles. Therefore, it is possible to perform the operation with different electrode needle intervals according to the characteristics of the patient. Here, it is preferable that the interval between any one of the electrode needles and the adjacent adjacent electrode needles is 5 mm to 15 mm. This gap is formed by inserting a plurality of electrode needles (410, 420, 430) into the tissue, and even if a signal in an RF (Radio Frequency) region is irradiated, the tissue does not fall into necrosis, Can be prevented.

The plurality of electrode needles 410, 420, and 430 may be provided to adjust the gap between the electrode needles. Any method of adjusting the gap may be used. For example, a sliding method may be applied.

That is, each of the plurality of electrode needles 410, 420, 430 is slidable in the longitudinal direction of the distal portion 300 relative to the distal portion 300 such that the electrode needles 410, 420, The interval between the electrode needles 410, 420, and 430 can be adjusted.

The electrode needles may be arranged in a row as shown in Fig. 10, but any arrangement other than a row arrangement is possible. As an example, they may be arranged in a zigzag fashion, and may be arranged vertically, horizontally and vertically with an interval of 90 degrees from the center of the distal portion 300 as an axis. Compared to the case where the electrode needles are arranged in a row, it has an advantage that a relatively wide area can be treated by one insertion.

Next, a procedure of performing an obstructive sleep apnea patient using the obstructive sleep apnea apparatus 1000 according to an embodiment of the present application will be described.

First, the practitioner injects the endoscope into the nasal cavity of the patient and observes the sidewall of the study dog and pharynx.

Next, after the handle 100 of the obstructive sleep apnea apparatus 1000 is grasped by hand, the control unit 110, which is formed separately from the buttons or the handle 100 provided on the handle 100, Is hingedly rotated about the proximal portion 200 and the distal portion 300 is rotated so as to be close to the treatment site. At this time, the plurality of electrode needles 410, 420, and 430 are embedded in the distal portion 300.

When a plurality of electrode needles 410, 420, and 430 are manipulated so as to protrude from the distal portion 300 to position the plurality of electrode needles 410 and 420 , 430) are inserted into the treatment site. Then, the plurality of electrode needles 410, 420, and 430 are manipulated to irradiate a signal in an RF (Radio Frequency) region to induce fibrosis of tissue at the treatment site. The electrode needle is inserted into a plurality of treatment regions in the direction in which the upper limit is secured, thereby inducing tissue fibrosis, so that the obstructive sleep apnea symptom can be treated.

It will be apparent to those skilled in the art that various modifications and variations may be made in the present invention without departing from the spirit and scope of the present invention as defined by the appended claims. It will be appreciated that embodiments are possible. Accordingly, the scope of protection of the present application should be determined by the claims.

(Explanation of Symbols)

100: Handle

110: Control device

120, 130:

200: proximal

300: distal

410, 420, 430: Electrode needle

Claims

A handle 100;

A proximal portion (200) connected to the handle (100) and extending from the handle (100);

A distal portion (300) hingedly connected to the proximal portion (200) by a first angle and extending from one end of the proximal portion (200); And

And a plurality of electrode needles (410, 420, 430) mounted on the distal portion (300).

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

The distal portion 300 is rotatable 360 degrees about the longitudinal axis of the proximal portion 200 in a connected state with the proximal portion 200,

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

Wherein the plurality of electrode needles (410, 420, 430) are hingedly rotatable with respect to the distal portion (300) by a predetermined second angle,

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

The plurality of electrode needles (410, 420, 430) are slidably disposed between a first position protruding from the distal portion (300) and a second position contained within the distal portion (300)

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

The control device (110)

A power supply unit 111 for supplying power;

An operation unit 112 for receiving an operation signal;

A control unit 113 for generating a control signal in accordance with an operation signal input to the operation unit 112; And

And a driving unit (114) for driving the distal portion (300) and the plurality of electrode needles (410, 420, 430) according to a control signal generated by the control unit (113)

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

Wherein the predetermined first angle is from 90 degrees to 180 degrees,

Obstructive Sleep Apnea Therapy.
The method of claim 3,

Wherein the predetermined second angle is between 0 and 180 degrees,

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

Wherein one of the plurality of electrode needles (410, 420, 430) is mounted on the distal portion (300) so as to be equally spaced from other adjacent electrode needles,

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

Wherein one of the plurality of electrode needles (410, 420, 430) is mounted on the distal portion (300) so as to be spaced apart from other adjacent electrode needles,

Obstructive Sleep Apnea Therapy.
The method according to claim 1,

The plurality of electrode needles 410, 420, and 430 irradiate a signal in an RF (Radio Frequency)

Wherein the RF plasma is generated by the signal,

Obstructive Sleep Apnea Therapy.