KR102175808B1 - Multi-directionally adjustable obstructive sleep apnea therapy device - Google Patents

Abstract

Provide obstructive sleep apnea treatment device. The obstructive sleep apnea treatment device according to the embodiment of the present application is connected to the handle 100, the handle 100, and a predetermined portion for the proximal portion 200 formed by extending from the handle 100, the proximal portion 200 It is connected to be hingedly rotatable by a first angle, and includes a distal portion 300 formed to extend from one end of the proximal portion 200 and a plurality of electrode needles 410, 420, and 430 mounted on the distal portion 300. I can.

Description

Multi-directional controllable obstructive sleep apnea treatment device {MULTI-DIRECTIONALLY ADJUSTABLE OBSTRUCTIVE SLEEP APNEA THERAPY DEVICE}

The present application relates to a multidirectional controllable obstructive sleep apnea treatment device.

In general, there are three types of sleep apnea. Obstructive sleep apnea is the most common form and involves reversible tissue obstruction of the upper respiratory tract. The other is central apnea, which is very rare and is the result of problems with the central nervous system that activates the respiratory mechanism. Lastly, it is mixed apnea, which is a case where obstructive and central apnea appear in sequence.

With reference to FIGS. 2 and 3, obstructive sleep apnea will be described in detail.

While sleeping, the throat through which the breathing air passes is narrowed and the flow of breathing air is obstructed, and the respiratory tract itself acts as a trembling plate, generating vibrational noise. When a person breathes, air passes through flexible structures such as the palate, uvula, tonsils, and tongue. During the day, the surrounding muscles help keep them in place, so they do not block the passage through which air passes. However, since the muscles relax and stretch during sleep, the air passage is partially narrowed, and when air passes through this part, the surrounding soft parts are vibrated, causing a snoring sound.

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

Figure 2 is a head structure diagram of a normal person or an anatomical structure diagram of a patient with obstructive sleep apnea in awake state, and Figure 3 is a state in which obstructive sleep apnea occurs by narrowing the pharynx due to sagging of the soft palate during sleep of a patient with obstructive sleep apnea. It is an anatomical structure diagram.

The hard palate 11 surrounds the hard bone in the ceiling of the mouth in the oral cavity 10, and the soft muscle soft palate 12 is coupled to the tip of the hard palate 11.

The two passages separated from each other by both nostrils 13 meet each other in the nasopharynx 18 after passing through the nasal cavity 14 and the upper nasal passage 15, the middle nasal passage 16, and the lower nasal passage 17. The soft palate 12 is located in front of the nasopharyngeal cavity 18, the oropharynx 19 is located below the nasopharyngeal cavity 18, and the hypopharyngeal 21 is located below the oropharyngeal cavity 19, The oropharyngeal (19) and hypopharyngeal (21) are both composed of wrinkled mucous membranes. And, the lower part of the hypopharyngeal (21) is separated into the esophagus (22) and trachea (23).

Air entering the nasal cavity 14 through the nostril 13 passes through the nasopharynx 18 and the hypopharynx 21 and enters the trachea 23. At this time, the soft palate 12 located in the upper respiratory tract through which the air passes. Obstructive sleep apnea occurs as the tissues of the tongue root (24), oropharyngeal (19) and hypopharyngeal (21) stretch and block the airways.

Since the muscles constituting the soft palate 12 are relaxed while a patient with obstructive sleep apnea is asleep, when a person lies upright and sleeps, it stretches toward the posterior pharyngeal wall and blocks the oropharynx 19 (see FIGS. 3 and 5).

In obstructive sleep apnea (OSA), upper respiratory tract (A1-A2) obstruction ends with a brief awakening. At the time of awakening, the airway opens again and breathing resumes. In severe cases, this condition occurs every minute during sleep, leading to repetitive sleep disturbances. In addition, repeated cessation of normal breathing can lead to a decrease in oxygen saturation in the blood. Excessive obesity in the neck area is a common cause of OSA. OSA is closely related to measures related to obesity, such as neck thickness, weight, and body-mass index (BMI). Men's shirt size is a useful predictor, so if a shirt's collar size is larger than approximately 42 cm, you should question the OSA. Other causes of this condition include medical problems such as hypothyroidism or enlarged tonsils. This symptom is also common in patients with retrognathia. This is due to the fact that patients with physical characteristics of East Asians show a lot of sleep apnea even if they are not overweight. The most common symptom of OSA is sleepiness, and many patients complain of pain that they do not feel well after sleeping. Sleep disturbance can cause decreased concentration, worse short-term memory, and increased irritability. OSA is usually accompanied by snoring and causes temporary respiratory arrest. Resumption of breathing is usually accomplished with a short breath or a strong snort. Patients with severe OSA who stop breathing once every two minutes or more than 30 times an hour are also at risk for other diseases such as ischemic heart disease, high blood pressure, and insulin resistance.

Treatment methods for sleep apnea include surgery and breathing aids, and the most commonly used and effective is the use of continuous positive airway pressure (CPAP). This method is to continuously blow air into the upper airway while sleeping by placing a mask on the nose or face (see Fig. 1).

Such a treatment using a continuous positive airway pressure device is known to have few side effects and has a good therapeutic effect, but the discomfort is large because the mask must be placed close to the nose and sleep, and the use rate (patient compliance, compliance) is lowered due to the heterogeneity of air pressure. There is a problem that it becomes.

International Publication WO 2010/060097 Korean Patent Registration No. 1601067 Publication International Publication WO 2014/012032

The present application was devised to solve the above problems. In particular, there is no inconvenience of wearing like a conventional positive airway pressure device, and the distal part can be hingedly rotated at various angles with respect to the proximal part, and the longitudinal axis of the proximal part can be rotated as a rotation axis, so that it is possible to perform treatment on the part that was difficult to access. We want to provide a sleep apnea treatment device.

An embodiment of the present application for solving the above problem is a handle 100, a proximal portion 200 connected to the handle 100 and extending from the handle 100, the proximal portion 200 A distal portion 300 formed to extend from one end of the proximal portion 200 and a plurality of electrode needles 410, 420, and 430 mounted on the distal portion 300 and hingedly rotatably connected by a predetermined first angle with respect to ), including obstructive sleep apnea treatment device.

In one embodiment, the distal part 300 may be provided to be rotatable 360 degrees about the longitudinal axis of the proximal part 200 while being connected to the proximal part 200.

In one embodiment, the plurality of electrode needles 410, 420, and 430 may be provided to 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, 430 may be provided to be slidable between a first position protruding from the distal part 300 and a second position embedded in the distal part 300. have.

In an embodiment, the control device 110 generates a control signal according to a power supply unit 111 for supplying power, an operation unit 112 receiving an operation signal, and an operation signal input to the operation unit 112. It may include a controller 113 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 controller 113.

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

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

In one embodiment, one of the plurality of electrode needles 410, 420, and 430 may be mounted on the distal portion 300 by being spaced apart from other adjacent electrode needles at equal intervals.

In one embodiment, any one of the plurality of electrode needles 410, 420, and 430 may be mounted on the distal part 300 by being spaced apart from other adjacent electrode needles.

In an embodiment, the plurality of electrode needles 410, 420, and 430 irradiate a signal in a radio frequency (RF) region to the inserted portion, and RF plasma may be generated by the signal.

This application as described above has the following effects.

First, since the electrode needle is inserted into the region including the soft palate and the left and right pharyngeal sidewalls of the patient and irradiates the signal in the RF (Radio Frequency) region, it induces fibrosis of the tissue in the direction where the upper airway is secured. Unlike treatment using a positive airway pressure device, there is no inconvenience of wearing, and sleep apnea caused by upper respiratory tract obstruction can be effectively treated.

Second, unlike conventional straight probes, 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 360 degrees with respect to the rotational axis while the hinge is rotated at a predetermined angle. This is possible.

Third, a plurality of electrode needles can also be rotated at various angles with respect to the distal part, allowing treatment on areas that were difficult to access in the past.

Fourth, the spacing between the plurality of electrode needles is constant, and the spacing is 5mm to 15mm, so that even if the signal in the RF area is irradiated, the tissue does not fall into necrosis, and at the same time, it prevents tissue damage caused by repeated procedures on the same area. I can.

Fifth, as the spacing between the plurality of electrode needles can be adjusted, more various types of procedures can be performed than when the spacing is fixed.

Sixth, since the treatment can be performed only by irradiating a signal in the RF region by inserting an electrode needle into the treatment site, the procedure is relatively simple and recovery can be achieved quickly.

1 is a view showing a state in which airways are secured using a continuous positive airway pressure device in a conventional sleep apnea treatment method.
2 and 3 are cross-sectional views of a head portion showing the internal structure of a person's nose, mouth and throat portions.
4 and 5 show a state of observing the airway by inserting an endoscope into the nasal cavity, and FIG. 4 is a view showing a state in which the airway is secured, and FIG. 5 is a state in which the soft palate is struck in the direction of the posterior pharyngeal wall and the airway is closed It is a figure shown.
6 is a schematic perspective view for explaining the obstructive sleep apnea treatment device according to an embodiment of the present application.
7 is a block diagram illustrating the configuration of the control device 110.
8 and 9 are for explaining the operation of the distal portion 300, FIG. 8 is a view for explaining the hinge rotation of the distal portion 300 relative to the proximal portion 200, FIG. 9 is a distal portion 300 It is a diagram for explaining rotation with the longitudinal axis of the proximal part 200 as a rotation axis.
10 is a view for explaining the operation (hinge rotation, sliding in the thickness direction, sliding in the longitudinal direction) of the distal portion 300 of the plurality of electrode needles 410, 420, 430.
11 is a view showing that the obstructive sleep apnea treatment device according to the embodiment of the present application is inserted into the nasal cavity and a plurality of electrode needles 410, 420, and 430 are inserted into the soft palate to treat obstructive sleep apnea.

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

6, the obstructive sleep apnea treatment device 1000 according to the 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 part held by the operator's hand. The handle 100 may be provided in a cylindrical shape, but any type is not limited as long as it is gripped by the operator's hand and is easy to use. The handle 100 may be made of a variety of materials to improve the grip, and as an example, a cushion material may be used.

It is preferable that both ends of the handle 100 have stepped portions 120 and 130 having a radius greater than that of the handle 100. Accordingly, the obstructive sleep apnea treatment device 1000 can be prevented from being separated from the operator's hand.

A control device 110 for controlling the obstructive sleep apnea treatment device 1000 is built into the handle 100. Alternatively, the control device 110 may be provided in the form of a console separate from the handle 100.

Referring to FIG. 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 111 is a part that supplies power for driving the obstructive sleep apnea treatment device 1000.

The manipulation unit 112 is a part that receives a manipulation signal from a practitioner. The operator uses separate buttons on the handle 100 to rotate the distal portion 300 and the plurality of electrode needles 410, 420, and 430, which will be described later, and the RF region of the plurality of electrode needles 410, 420, and 430. Manipulation signals such as signal investigation can be input.

The control unit 113 generates different control signals according to the operation signal input to the operation unit 112.

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

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

The proximal portion 200 is connected to the handle 100 and is a portion formed to extend from the handle 100. The distal part 300 is a part that guides the distal part 300 to approach the treatment site, and it is preferable that the handle 100 is provided to be adjustable in length. Since the distance from the oral cavity to the soft palate or the pharynx varies for each patient to be treated, the proximal portion 200 is provided to be adjustable in length to enable elaborate treatment.

The proximal portion 200 serves as a bridge that mechanically and electrically connects the handle 100 and the distal portion 300, and the surface of the proximal portion 200 is preferably covered with a material of an insulating material.

The distal portion 300 is a portion formed extending from one end of the proximal portion 200. It is connected to the proximal part 200 so as to be hingedly rotatable with respect to the proximal part 200 by a predetermined first angle, where the first predetermined angle is preferably 90 degrees to 180 degrees. When the first predetermined angle is 90 degrees, the distal portion 300 is a vertical angle with respect to the proximal portion 200, and when the first predetermined angle is 180 degrees, it is a horizontal angle (see FIG. 8). The operator may position the distal part 300 at the treatment site by adjusting the angle of the distal part 300 with respect to the proximal part 200.

In addition, the distal portion 300 is in a hinge-rotated state with respect to the proximal portion 200 (that is, at any one of 90 degrees to 180 degrees), so that the longitudinal axis of the proximal portion 200 can be rotated 360 degrees. It is prepared.

The distal portion 300 can be hingedly rotated with respect to the proximal portion 200 by a predetermined first angle, and the longitudinal axis of the proximal portion 200 can be rotated 360 degrees with respect to the rotation axis while being positioned at any one of the predetermined first angles. Therefore, the operator can easily position the distal part 300 at the treatment site while adjusting the direction of the obstructive sleep apnea treatment device 1000 according to the treatment site.

The plurality of electrode needles 410, 420, and 430 is a part that is inserted into a treatment site and irradiates a signal in a radio frequency (RF) region to the inserted site. Here, a plurality of electrode needles 410, 420, and 430 will be described as an example, but it is possible to provide a number of two or less or four or more.

RF plasma is generated by the signal irradiated by the plurality of electrode needles 410, 420, 430, and absorbs a part of the tissue to reduce the volume of the tissue and at the same time induce fibrosis in the wound healing process to make the tissue tight. . In this case, it is preferable that the plurality of electrode needles 410, 420, and 430 are inserted in the direction in which the upper respiratory tract is extended, that is, a portion including the soft palate and the pharynx.

The plurality of electrode needles 410, 420, and 430 are connected to the distal part 300 so as to be hingedly rotatable with respect to the distal part 300 by a predetermined second angle, where the second predetermined angle is preferably 0 degrees to 180 degrees. Do. Therefore, the operator may position the distal part 300 to be close to the treatment site, and adjust the angle of the plurality of electrode needles 410, 420, and 430 with respect to the distal part 300 to insert it into the treatment site.

It is preferable that the plurality of electrode needles 410, 420, 430 are also provided to be slidable in the thickness direction of the distal part 300 with respect to the distal part 300. Specifically, the plurality of electrode needles 410, 420, and 430 slide between a first position protruding from the distal part 300 and a second position embedded in the distal part 300, and the plurality of electrode needles 410 , 420, 430) can be protruded only when necessary.

Any one of the plurality of electrode needles 410, 420, and 430 may be provided on the distal portion 300 such that it is spaced equally or spaced apart from other adjacent electrode needles. Therefore, it has the advantage that the procedure can be performed by varying the spacing of electrode needles according to the characteristics of the patient. Here, it is preferable that the distance between any one electrode needle and another adjacent electrode needle is 5 mm to 15 mm. In this interval range, even if a plurality of electrode needles 410, 420, 430 are inserted into the tissue and irradiated with a signal in the RF (Radio Frequency) region, the tissue does not fall into necrosis, and at the same time, tissue damage due to repeated procedures on the same site. This is the range that can be prevented.

The plurality of electrode needles 410, 420, and 430 may be provided so that the spacing between the electrode needles is adjusted. Any method of adjusting the spacing may be applied, but as an example, a sliding method may be applied.

That is, each of the plurality of electrode needles 410, 420, and 430 is provided so as to be slidable in the longitudinal direction of the distal part 300 with respect to the distal part 300, and the electrode needles 410, 420, and 430 have the length of the distal part 300 As it slides in the direction, the spacing of each electrode needle 410, 420, and 430 can be adjusted.

The electrode needles may be arranged in a line as shown in FIG. 10, but any arrangement other than a line arrangement is possible. As an example, they may be arranged in a zigzag shape, and may be arranged vertically, horizontally, and spaced 90 degrees apart from each other with 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 the advantage that a relatively large area can be treated with one insertion.

Next, a procedure for treating a patient with obstructive sleep apnea using the obstructive sleep apnea treatment device 1000 according to an embodiment of the present application will be described.

First, the operator injects an endoscope into the patient's nasal cavity and observes the side walls of the soft palate and pharynx.

Next, after gripping the handle 100 of the obstructive sleep apnea treatment device 1000 by hand, the distal portion 300 by manipulating buttons provided on the handle 100 or a control device 110 formed separately from the handle 100 The hinge is rotated with respect to the proximal part 200, and the distal part 300 is rotated to be close to the treatment site. In this case, the plurality of electrode needles 410, 420, and 430 are embedded in the distal portion 300.

When the distal part 300 is positioned to be close to the treatment site (soft soft palate, pharyngeal sidewalls), a plurality of electrode needles 410, 420, and 430 are manipulated to protrude from the distal part 300 so that the plurality of electrode needles 410, 420 , 430) is inserted into the treatment site. In addition, the plurality of electrode needles 410, 420, and 430 are manipulated to irradiate a signal in a radio frequency (RF) region, thereby inducing fibrosis of the tissue at the treatment site. Since the electrode needles are inserted into a plurality of treatment sites in the direction in which the upper airway is secured to induce tissue fibrosis, obstructive sleep apnea symptoms can be treated.

As described above, in the present specification, the present application has been described with reference to the embodiment shown in the drawings so that those skilled in the art can easily understand and reproduce this application, but this is only illustrative, and those skilled in the art can use various modifications and equivalents from the embodiment of the present application. It will be appreciated that embodiments are possible. Therefore, the scope of protection of the present application should be determined by the claims.

100: handle
110: control device
120, 130: stepped portion
200: proximal
300: distal
410, 420, 430: electrode needle

Claims (10)

Handle 100;
A proximal portion 200 connected to the handle 100 and extending from the handle 100;
The angle formed with the proximal part 200 is rotatably connected in the range of 90 to 180 degrees, is formed extending from one end of the proximal part 200, and in a state connected to the proximal part 200, A distal portion 300 rotatably provided with a vertical axis as a rotation axis; And
A first position mounted on the distal part 300 and protruding from the distal part 300 in which an angle made with the distal part 300 is rotatable in a range of 0 degrees to 180 degrees at a position mounted on the distal part 300 And a plurality of electrode needles 410, 420, and 430 that are movable between second positions embedded in the distal part 300,
Signals in the RF (Radio Frequency) region are irradiated from the plurality of electrode needles 410, 420, 430, and the plurality of electrode needles 410, 420, 430 extend the upper respiratory tract due to the irradiation of signals in the RF region. Inserted into the area including the side walls of the soft palate and pharynx,
Obstructive sleep apnea treatment device.
delete delete delete The method of claim 1,
Further comprising a control device 110 for controlling the obstructive sleep apnea treatment device,
The control device 110,
A power supply unit 111 for supplying power;
A manipulation unit 112 receiving a manipulation signal;
A control unit 113 for generating a control signal according to an operation signal input to the operation unit 112; And
Including; 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 treatment device.
delete delete The method of claim 1,
Any one of the plurality of electrode needles 410, 420, 430 is mounted on the distal portion 300 so that it is arranged at equal intervals with other adjacent electrode needles,
Obstructive sleep apnea treatment device.
The method of claim 1,
Any one of the plurality of electrode needles 410, 420, 430 is mounted on the distal portion 300 so that it is arranged spaced apart from other adjacent electrode needles,
Obstructive sleep apnea treatment device.
The method of claim 1,
RF plasma is generated by the signal in the RF region,
Obstructive sleep apnea treatment device.

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