KR102428353B1 - High intensity focused ultrasound operating apparatus and operating method thereof - Google Patents

Abstract

Cartridge that is made in the shape of a bar so that it can be inserted into the vagina of the subject to be treated, is detachably provided to the treatment handpiece, and has an ultrasound treatment unit inside that generates High Intensity Focused Ultrasound (HIFU) ; a driver for driving the ultrasound treatment unit so that the ultrasound treatment unit moves back and forth along the longitudinal direction of the cartridge; an image probe for imaging skin tissue at a predetermined depth from the surface of the vaginal skin; and a controller for controlling irradiation conditions of the high-intensity focused ultrasound by analyzing the image data transmitted from the image probe.

Description

HIGH INTENSITY FOCUSED ULTRASOUND OPERATING APPARATUS AND OPERATING METHOD THEREOF

The present invention relates to a high-intensity focused ultrasound treatment apparatus and a method thereof, and more particularly, to a high-intensity focused ultrasound treatment apparatus capable of improving gynecological disease treatment and/or vaginal contraction treatment efficiency and a method thereof.

Recently, interest in skin beauty and obesity treatment is increasing day by day, and accordingly, various medical devices for skin beauty and obesity treatment are being developed. For example, various skin care medical devices for patients who wish to perform face lifting or skin tightening procedures are being developed, and on the other hand, medical devices for treating obese patients are being developed.

As a medical device for skin care, there are invasive medical devices that cut skin tissue, but as safety issues and patient rejection are highlighted, non-invasive medical devices that can be operated without skin tissue incision are attracting attention. have. This trend appears similarly in the fields of skin care and obesity treatment, and this trend is expected to appear in other medical fields as well.

In line with this trend, an ultrasonic medical device using High Intensity Focused Ultrasound (HIFU) as a non-invasive medical device has recently been in the spotlight. For example, there is an ultrasonic medical device that non-invasively performs a skin lifting or skin tightening procedure by irradiating high-intensity focused ultrasound to the inside of the skin tissue for skin cosmetic procedures, and high-intensity focused ultrasound to the subcutaneous fat layer for the treatment of obesity ( There is an ultrasonic medical device that non-invasively burns or melts and decomposes adipose tissue by irradiating High Intensity focused ultrasound (HIFU).

Meanwhile, the number of patients with gynecological diseases has been steadily increasing in recent years. Gynecological diseases can be broadly classified into oncological diseases, inflammatory diseases, menstrual disorders, sexually transmitted diseases, and sexual dysfunction. More specifically, representative tumors include cervical cancer and ovarian cancer, and tumorous diseases include uterine fibroids. Inflammatory diseases include cold-headedness, and menstrual disorders include amenorrhea, menstrual pain, and menstrual cycle abnormalities. In addition, sexual dysfunction includes sexual desire disorder, sexual arousal disorder, orgasm disorder, pain disorder, and vaginal contraction disorder. Among them, sexual dysfunction refers to a symptom in which satisfaction is not obtained or there is difficulty through sexual activity. Traditionally, sexual dysfunction in women was often a natural disability due to childbirth or aging, but recently, the number of patients with sexual dysfunction is steadily increasing even in the young age of 20-30. There are various causes for this phenomenon, but excessive smoking and drinking, drug abuse, and stress are known to be the main causes of the increase in sexual dysfunction among young people.

The treatment methods for these gynecological diseases can be largely divided into pharmaceutical treatments and treatment using medical devices. Among these, treatment using medical devices refers to treatment using heat therapy, moxibustion, sitz bath, and laser therapy. However, it is known that the treatment using a heat treatment device, mugwort moxibustion, and sitz bath is not a direct treatment, and its effect is also very insignificant. In addition, in the case of treatment using a laser treatment device, bleeding occurs with strong pain during the procedure, and pain and side effects occur even after the procedure, which gives great inconvenience to daily life.

US Patent Publication No. 2007-0232913 Republic of Korea Patent Publication No. 2011-0091831 Republic of Korea Patent Publication No. 2007-0065332 Republic of Korea Patent Publication No. 2012-0116908 Republic of Korea Patent Publication No. 2011-0121701

An object of the present invention is to provide a high-intensity focused ultrasound treatment device capable of improving the safety of gynecological disease treatment and/or vaginal contraction procedure.

SUMMARY OF THE INVENTION An object of the present invention is to provide a high-intensity focused ultrasound treatment device that prevents thermal lesions of high-intensity focused ultrasound from escaping from a preset skin tissue by determining whether a cartridge is normally positioned inside the vagina during a procedure.

An object of the present invention is to provide a high-intensity focused ultrasound treatment device capable of performing non-invasive cosmetic procedures and non-invasive treatment of gynecological diseases as a single device.

An object of the present invention is to provide a high-intensity focused ultrasound treatment method capable of improving the safety of gynecological disease treatment and/or vaginal contraction procedure.

An object of the present invention is to provide a high-intensity focused ultrasound treatment method for preventing thermal lesions of high-intensity focused ultrasound from escaping from a preset skin tissue by determining whether a cartridge is normally positioned inside the vagina during the procedure.

An object of the present invention is to provide a treatment method using high-intensity focused ultrasound that can perform non-invasive cosmetic procedures and non-invasive treatment of gynecological diseases as a single device.

The high-intensity focused ultrasound treatment apparatus according to the present invention

The high-intensity focused ultrasound treatment method according to the present invention

The high-intensity focused ultrasound treatment apparatus according to the present invention compares the image data of the internal skin tissue of the vagina to form a thermal lesion with reference data and changes the treatment condition of the high-intensity focused ultrasound to a suitable treatment condition, thereby treating gynecological diseases and/or improve the safety of vaginal contraction procedures.

The high-intensity focused ultrasound treatment apparatus according to the present invention performs the procedure after determining whether the cartridge inserted into the vagina is normally positioned inside the vagina during the procedure, so that the thermal lesions are accurately irradiated to the preset skin tissue, thereby treating gynecological diseases and / Alternatively, the safety of the vaginal contraction procedure may be improved.

The high-intensity focused ultrasound treatment apparatus according to an embodiment of the present invention can provide cartridges having treatment conditions suitable for the condition of the subject to be treated in the treatment handpiece, and then mount the selected cartridge to the treatment handpiece to perform the treatment. , it is possible to perform patient-specific procedures with a single device through cartridge replacement.

The high-intensity focused ultrasound treatment method according to the present invention compares the image data of the skin tissue inside the vagina to form a thermal lesion during the procedure with reference data and changes the treatment condition of the high-intensity focused ultrasound to a suitable treatment condition, thereby treating gynecological diseases and/or improve the safety of vaginal contraction procedures.

The high-intensity focused ultrasound treatment method according to the present invention performs the procedure after determining whether the cartridge inserted into the vagina is normally positioned inside the vagina during the procedure, so that the thermal lesions are accurately irradiated to the preset skin tissue, thereby treating gynecological diseases and / Alternatively, the safety of the vaginal contraction procedure may be improved.

In the high-intensity focused ultrasound treatment method according to an embodiment of the present invention, cartridges having treatment conditions suitable for the condition of the subject to be treated are prepared compatible with the treatment handpiece, and then the selected cartridge is mounted on the treatment handpiece to perform the treatment, As a single device, a patient-specific procedure can be performed through cartridge replacement.

1 is a perspective view schematically illustrating an apparatus for high-intensity focused ultrasound treatment according to an embodiment of the present invention.
FIG. 2 is a view for explaining a coupling process of the first surgical handpiece and the first cartridge shown in FIG. 1 .
3 is a cross-sectional view schematically illustrating the first surgical handpiece and the first cartridge shown in FIG. 1 .
4 is a view for explaining the first and second cartridges according to an embodiment of the present invention.
5 is a flowchart schematically illustrating a high-intensity focused ultrasound treatment method using the first treatment handpiece shown in FIG. 1 .
6 is a block diagram schematically illustrating a gynecological disease treatment and/or vaginal contraction procedure of the high-intensity focused ultrasound treatment apparatus using the second treatment handpiece and the third cartridge according to an embodiment of the present invention.
7 is a perspective view showing the second surgical handpiece and the third cartridge shown in FIG. 1 .
8 is a view for explaining the mutual coupling process of the second handpiece and the third cartridge shown in FIG.
9 is a first cross-sectional view showing the coupling structure of the second treatment handpiece and the third cartridge shown in FIG. 7 .
FIG. 10 is a second cross-sectional view illustrating a coupling structure of the second surgical handpiece and the third cartridge shown in FIG. 7 .
11 is a view for explaining various examples of the arrangement structure of the ultrasound treatment unit and the image probe shown in FIG. 7 .
12 is a flowchart for explaining a gynecological disease and vaginal contraction procedure according to an embodiment of the present invention.
13 is a view for explaining a gynecological disease and vaginal contraction procedure according to an embodiment of the present invention.

Advantages and features of the present invention, and a method of achieving them, will become apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and may be implemented in various different forms. The present embodiments may be provided so that the disclosure of the present invention is complete, and to fully inform those of ordinary skill in the art to the scope of the present invention. Like reference numerals refer to like elements throughout the specification.

The terms used herein are for the purpose of describing the embodiments and are not intended to limit the present invention. In this specification, the singular also includes the plural, unless specifically stated otherwise in the phrase. As used herein, 'comprise' and/or 'comprising' refers to the presence of one or more other components, steps, operations and/or elements mentioned. or addition is not excluded.

Further, the embodiments described herein will be described with reference to cross-sectional and/or plan views, which are ideal illustrative views of the present invention. In the drawings, the detailed size, shape, thickness, curvature, etc. of each component are exaggerated or schematically exaggerated for effective description of technical content, and the shape may be deformed by tolerance.

Hereinafter, an apparatus for high-intensity focused ultrasound treatment and a method thereof according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings.

1 is a perspective view schematically illustrating an apparatus for high-intensity focused ultrasound treatment according to an embodiment of the present invention, and FIG. 2 is a view for explaining a process of coupling the first surgical handpiece and the first cartridge shown in FIG. 1 . And, FIG. 3 is a cross-sectional view schematically illustrating the first surgical handpiece and the first cartridge shown in FIG. 1 .

1 to 3 , the high-intensity focused ultrasound treatment apparatus 10 according to an embodiment of the present invention can perform two or more different treatments using high-intensity focused ultrasound (HIFU). It may be a medical device.

In this case, the two or more procedures may include non-invasive face lifting or skin tightening procedures, non-invasive reduction or removal of subcutaneous fat layer, and treatment of gynecological diseases and/or vaginal contractions. have.

The high-intensity focused ultrasound (hereinafter, referred to as 'HIFU') may be for forming a thermal lesion (12) by focusing the ultrasound to be focused on one focal point. Such a thermal lesion 12 may be a thermal focus in a high temperature state of approximately 60° C. or higher. Therefore, the high-intensity focused ultrasound treatment device 10 forms the thermal lesion 12 in the dermal layer, fascia layer, or SMAS layer located at about 1.5 mm to 4.5 mm from the skin surface to perform face lifting or skin lifting. A skin tightening operation may be performed, or a fat reduction or removal operation may be performed by forming the thermal lesion 12 on the subcutaneous fat layer located at approximately 6.0 mm to 15.0 mm from the skin surface. Alternatively, a thermal lesion (22 in FIG. 11) is formed on the skin tissue of a certain depth from the surface of the vagina of a woman or a muscle responsible for vaginal contraction, such as Endopelvic Fascia (EPF, 70 in FIG. 11). A procedure for regenerating or recovering the half muscle group 70 may be performed.

The high-intensity focused ultrasound treatment device (hereinafter referred to as 'HIFU treatment device', 10) includes an equipment body 100, a first handpiece assembly 200, a first cartridge set 300, and a second handpiece assembly 400. ), and may include a second cartridge set 500 and the like.

The equipment body 100 may be for providing information related to the procedure to the operator (not shown), and for the operator to operate or manipulate the HIFU treatment device 10 . For example, the equipment main body 100 may be provided with an indicator 110 for displaying information related to the operator's operation, and a manipulation unit 120 for the operator to operate or control the HIFU operation apparatus 10, and the like. A touch screen or the like may be used as the manipulation unit 120 .

The first handpiece assembly 200 may include a first surgical handpiece 210 and a first connection cable 220 . The first treatment handpiece 210 is for irradiating HIFU to a subject to be treated, and may be provided in a hand-held form to improve user convenience. For example, the first treatment handpiece 210 may include a first handle portion 212 so that the operator can hold the first treatment handpiece 210 . A first operation switch 212a for the operator to control the ultrasound irradiation operation may be provided at the upper end of the first handle portion 212 . The first connection cable 220 may be for electrically and physically connecting the first surgical handpiece 210 and the equipment body 100 . One end of the first connection cable 220 may be connected to the first surgical handpiece 210 , and the other end may be detachably connected to the equipment body 100 in a connecting type.

The first cartridge set 300 may be a set consisting of a plurality of cartridges. For example, the first cartridge set 300 may include a first cartridge 310 and a second cartridge 320 having different treatment conditions from each other. The first cartridge 310 and the second cartridge 320 are cartridges for different purposes of treatment, and in detail, the first cartridge 310 is for a non-invasive reduction or removal of the subcutaneous fat layer, and The two cartridges 320 may be for non-invasive face lifting or skin tightening procedures. Detailed information such as a procedure for each of the first and second cartridges 310 and 320 and operating conditions will be described later.

Each of the first and second cartridges 310 and 320 may be configured to be detachably attached to the first surgical handpiece 210 . For example, a first guide part 214 for fastening with a cartridge (such as 310 in FIG. 2 ) of the first cartridge set 300 may be provided at the front end of the first handle part 212 . In one embodiment, the first guide part 214 may be provided in the shape of a bar protruding in the front end direction of the first handle part 212 . In addition, a through hole (312a) having a shape corresponding to the cross-section of the first guide part 214 may be provided in the central region of the first cartridge body 312 . Therefore, as shown in Figure 2 (a), by inserting the first guide portion 214 in the through hole (312a), the first cartridge 310 to the first treatment handpiece (210) can be mounted At this time, in order to prevent the mounting state of the first cartridge 310 from being released, a locking device 214a may be provided at the front end of the first guide part 214, and the operator may use the locking device 214a) By rotating, the first cartridge 310 can be locked or unlocked.

A first image probe 216 for imaging a tissue to be treated may be provided inside the first guide part 214 . The first image probe 216 may be provided in a substantially bar shape along the first guide part 214 . The first image probe 216 may generate image ultrasound to image the skin tissue to be treated, that is, the subcutaneous fat layer. The first guide part 214 is the first and second cartridges 310 and 320 when the first and second cartridges 310 and 320 are fastened to the first surgical handpiece 210, the first and second cartridges 310 and 320 It may be provided to be positioned on top of the treatment transducer 314 provided in each. Accordingly, the treatment transducer 314 performs a function of irradiating HIFU while moving back and forth in the lower portion of the first guide unit 214, and thus the treatment transducer 314 may be referred to as an ultrasound treatment unit. have. Also, the first image probe 216 may generate a separate ultrasound image to image the subcutaneous fat layer and display it on the display unit 110 .

Here, for the front-back movement of the treatment transducer 314 , the first actuator 218 may be provided on the first surgical handpiece 210 . In one embodiment, a stepping motor or the like may be used as the first actuator 218 , and the first actuator 218 and the treatment transducer 314 may be connected to each other by a support 316 . have. Accordingly, by the first actuator 218 moving the support 316 back and forth, the therapeutic transducer 314 can be moved back and forth.

The first actuator 218 may move the treatment transducer 314 in the front-rear direction so that the treatment transducer 314 has a treatment section of approximately 40.0 mm to 100.0 mm. More specifically, the first actuator 218 may be provided as a stepping motor, and may cause the treatment transducer 314 to move back and forth by a length selected within a range of approximately 40.0 mm to 100.0 mm. Here, the first driver 218 shown in FIG. 3 may be a coaxial cross-section of the stepping motor. At this time, the therapeutic transducer 314 may irradiate HIFU while moving the range. The treatment transducer 314 is set to irradiate HIFU at regular intervals so that the thermal lesion 12 forms a plurality of dots along the same line, or the thermal lesion 12 forms a straight line without a gap. Can be set to irradiate HIFU.

On the other hand, when the front-back movement length of the treatment transducer 314 is less than 40.0 mm, the treatment area for skin lifting, skin tightening, or subcutaneous fat layer is small, so the treatment time may be very long. In addition, since the subcutaneous fat layer is bent in both directions based on the navel of the person, when the front-back movement range of the treatment transducer 314 exceeds 100.0 mm, the treatment transducer 314 is HIFU to a certain depth. Since it is set to irradiate the subcutaneous fat layer, the initial HIFU irradiation depth and the final HIFU irradiation depth are different, and the risk of HIFU irradiation to the area outside the subcutaneous fat layer may increase. This risk can similarly arise from a skin lifting or skin tightening point of view. Accordingly, the first actuator 218 is configured to allow the therapeutic transducer 314 to be moved back and forth within a range of approximately 40.0 mm to 100.0 mm, and more preferably within a range of 60.0 mm to 80.0 mm. This may be suitable for shortening the procedure time while ensuring the safety of the procedure.

On the other hand, each of the first and second cartridges 310 and 320 may be provided with a cooling fluid for cooling the heat generated by the operation of the treatment transducer 314 . As an embodiment, each of the first and second cartridges 310 and 320 is provided so that cooling water can be filled therein, and the cooling water is circulated by a separate cooling water circulation line (not shown). , it is possible to prevent overheating of the treatment transducer 314 . To this end, when the first and second cartridges 310 and 320 are mounted on the first surgical handpiece 210, the coolant in the first and second cartridges 310 and 320 is the coolant circulation line. is connected to, and the cooling water circulation line is connected to a cooling water storage container (not shown) inside the equipment body 100 , and may circulate the cooling water in the cooling water storage container. Meanwhile, although not shown, a circulation means such as a pump may be installed on the cooling water circulation line.

In the high-intensity focused ultrasound treatment apparatus 10 having the structure as described above, the first cartridge 310 and the second cartridge 320 having conditions suitable for different types of treatment are the first treatment handpiece 210 . Since it can be selectively mounted on the first and second cartridges (310, 320), the operator selects a cartridge capable of performing a desired procedure, and attaches it to the first treatment handpiece (210) for the treatment can do. In this case, as compared to a high-intensity focused ultrasound medical device capable of only a single-purpose procedure, various procedures can be performed only by replacing a cartridge as a single device, so that the structure of a multi-purpose ultrasound medical device can be implemented.

In particular, in the case of the non-invasive ultrasound procedure for face lifting and the non-invasive ultrasound procedure for reducing the subcutaneous fat layer, the depth and intensity conditions of the high-intensity focused ultrasound and the skin tissue of the imaging target are completely different, so these two procedures can be performed with one device. It was very difficult to implement as However, the high-intensity focused ultrasound treatment apparatus 10 is provided with a first image probe 216 shared for the first and second cartridges 310 and 320 of different types in the first treatment handpiece 210 . After that, by replacing the first and second cartridges 310 and 320 to enable heterogeneous treatment, this technical barrier was resolved.

As described above, the high-intensity focused ultrasound treatment apparatus 10 according to an embodiment of the present invention is a first cartridge set ( 300), by selecting a cartridge capable of performing a desired procedure from among the first and second cartridges 310 and 320 and mounting it on the first treatment handpiece 210, a desired treatment for each treatment purpose can be implemented Accordingly, the high-intensity focused ultrasound treatment device according to the present invention is provided with treatment handpieces having various treatment purposes, and then uses the treatment handpiece for the desired treatment purpose during face lifting or skin tightening treatment and reduction or removal of subcutaneous fat layer. By performing the procedure, it is possible to perform two or more high-intensity focused ultrasound procedures with a single device. In addition, the high-intensity focused ultrasound treatment apparatus according to an embodiment of the present invention can be performed by compatibly providing cartridges having treatment conditions suitable for the condition of the subject to be treated in the treatment handpiece, and then mounting the selected cartridge to the treatment handpiece. Therefore, it is possible to perform a patient-customized procedure through cartridge replacement as a single device.

Continuing, the first cartridge set 300 according to the embodiment of the present invention will be described in detail. Here, the content overlapping with the description of the above-described high intensity focused ultrasound treatment apparatus 10 may be omitted or simplified.

Figure 4 is a view for explaining the first and second cartridges (310, 320) according to an embodiment of the present invention. More specifically, Figure 4 (a) is a view for explaining the operating conditions of the first cartridge 310 according to an embodiment of the present invention, Figure 4 (b) is a second cartridge ( 320) is a diagram for explaining the operating conditions.

Referring to Figure 4 (a), the first cartridge 310 according to an embodiment of the present invention may be for the reduction or removal of the subcutaneous fat layer. In one embodiment, the first cartridge 310 may be used when the thickness T1 of the subcutaneous fat layer 20 to be treated is 25.0 mm or more. That is, the first cartridge 310 may be set to a condition that can be operated when the thickness T1 of the subcutaneous fat layer 20 is 25.0 mm. In this case, the surgical patient may be highly obese. The first cartridge 310 is the HIFU lesion (lesion: 30) while the vertical length (H1) is adjusted to approximately 8.0mm to 12.0mm, the irradiation depth from the skin surface of the HIFU to be adjusted to approximately 11.0mm to 15.0mm can If the vertical length H1 of the HIFU lesion 30 is less than approximately 8.0 mm, the reduction efficiency of the subcutaneous fat layer 20 may be reduced. Conversely, when the vertical length H1 of the HIFU lesion 30 exceeds approximately 12.0 mm, the HIFU lesion may be formed in an area outside the subcutaneous fat layer 20 . In addition, when the irradiation depth is less than about 11.0 mm or more than about 15.0 mm, the HIFU lesion 30 may escape the subcutaneous fat layer 20 during the procedure. Therefore, in the treatment transducer 314 of the first cartridge 310, the vertical length (H1) of the HIFU lesion 30 is adjusted to approximately 10.0mm±2.0mm, and the irradiation depth of the HIFU is 13.0mm±2.0 When adjusted to mm, even when the thickness (T1) of the subcutaneous fat layer 20 is 25.0 mm or more, the risk of being operated on skin tissues other than the subcutaneous fat layer 20 can be alleviated.

In another embodiment, the first cartridge 310 may be used when the thickness T1 of the subcutaneous fat layer 20 to be treated is 7.0 mm or more and less than 25.0 mm. That is, the first cartridge 310 may be set to a condition that can be operated when the thickness T1 of the subcutaneous fat layer 20 is at least 7.0 mm and thinner than 25.0 mm. In this case, the surgery patient may be highly likely to be a first obese patient. In this case, the first cartridge 310 is the HIFU lesion (lesion: 30) while the vertical length (H1) is adjusted to approximately 5.0mm to 9.0mm, the irradiation depth of the HIFU from the skin surface is approximately 6.0mm to 10.0mm can be adjusted to If the vertical length H1 of the HIFU lesion 30 is less than about 5.0 mm, the reduction efficiency of the subcutaneous fat layer 20 may be reduced. Conversely, when the vertical length H1 of each of the HIFU lesions 30 exceeds approximately 9.0 mm, the HIFU lesion 30 may be formed in an area outside the subcutaneous fat layer 20 . In addition, when the irradiation depth is less than about 6.0 mm or more than about 10.0 mm, the HIFU lesion 30 may escape the subcutaneous fat layer 20 during the procedure. Therefore, in the treatment transducer 314 of the first cartridge 310, the vertical length (H1) of the HIFU lesion 30 is adjusted to approximately 7.0mm±2.0mm, and the irradiation depth of the HIFU is 8.0mm±2.0 When adjusted to mm, even when the thickness T1 of the subcutaneous fat layer 20 is 7.0 mm or more and less than 25.0 mm, the risk of being operated on skin tissues other than the subcutaneous fat layer 20 can be alleviated.

Here, the treatment transducer 314 of the first cartridge 310 may generate a plurality of the HIFU lesions 30 while performing a forward motion or a backward motion, that is, a linear reciprocating motion. At this time, the interval between the HIFU lesions 30 is absent or less than 1.0 mm, so that the HIFU lesions 30 result in a straight line or column shape without interruption in the middle, and the subcutaneous fat layer 20 can be thermally decomposed. However, when the HIFU lesions 30 overlap each other, the pain felt by the recipient may be great, so it may be ideal that the HIFU lesions 30 be irradiated as close as possible under the condition that the HIFU lesions 30 do not overlap.

Referring to Figure 4 (b), the second cartridge 320 according to an embodiment of the present invention may be for a face lifting or skin tightening procedure, unlike the first cartridge 310 described above. In one embodiment, the skin tissue 40 to be treated of the second cartridge 320 may include a dermal layer, a fascia layer, and a SMAS layer at a depth of approximately 1.5 mm to 4.5 mm from the skin surface. At this time, the second cartridge 320 may be adjusted so that the HIFU lesion (lesion: 50) is generated in a generally spherical, oval, or droplet shape having a diameter of approximately 0.5 mm to 1.5 mm. If the diameter of the HIFU lesion 50 is less than about 0.5 mm, the damage to the HIFU target tissue is very small, and it may be difficult to obtain the effect of face lifting or skin tightening through regeneration after intentional skin damage. Conversely, when the diameter of the HIFU lesion 50 exceeds 1.5 mm, the HIFU lesion 50 may be formed in an area outside the skin tissue 40 to be treated. In addition, when the irradiation depth is less than about 1.5 mm or more than about 4.5 mm, the HIFU lesion 50 may deviate from the skin tissue 40 to be treated during the procedure. Therefore, in the treatment transducer 314 of the second cartridge 320, the diameter of the HIFU lesion 50 is adjusted to approximately 1.0mm±0.5mm, and the irradiation depth of the HIFU is adjusted to 1.5mm to 4.5mm. may be desirable. Most preferably, the irradiation depth of the HIFU lesion 50 is any one selected from 1.5mm, 3.0mm, and 4.5mm, and the diameter of the HIFU lesion 50 may be about 1.0mm±0.2mm.

Here, the treatment transducer of the second cartridge 320 may generate a plurality of the HIFU lesions 50 while performing a forward motion or a backward motion, that is, a linear reciprocating motion. At this time, the interval between the HIFU lesions 50 is approximately 0.5mm to less than 2.0mm, so that the HIFU lesions 50 are spaced apart from each other as a result, a plurality of dots spaced apart from each other along the same line It can be adjusted to achieve dots. If the distance between the HIFU lesions 50 is less than 0.5mm, the HIFU lesions 50 are consequently connected to each other, and problems such as skin necrosis may occur as excessive thermal wounds on the skin tissue. Conversely, when the distance between the HIFU lesions 50 exceeds 2.0mm, the distance between the HIFU lesions 50 is very large, and as a result, the face lifting or skin tightening effect may be significantly reduced.

Subsequently, a detailed description will be given of a procedure using the first treatment handpiece of high-intensity focused ultrasound according to the embodiment of the present invention as described above. Here, the contents overlapping with the description of the high intensity focused ultrasound treatment apparatus 10 according to the embodiment of the present invention described above may be omitted or simplified.

5 is a flowchart schematically illustrating a high-intensity focused ultrasound treatment method using the first treatment handpiece shown in FIG. 1 . 1 to 5 , first, a type of treatment to be performed on a subject to be treated may be selected (S110). For example, the operator (not shown) may select the type of treatment to be performed on the subject (not shown). In this case, the selectable type of treatment may include at least one of a face lifting or skin tightening procedure and a subcutaneous fat layer reduction or removal procedure. If the operator intends to perform a procedure to reduce or remove the subcutaneous fat layer, the operator considers the thickness of the subcutaneous fat layer, the depth of the subcutaneous fat layer, and other conditions of the subject to be treated. It is possible to select the first cartridge 310 according to the. Here, in order to confirm the thickness of the subcutaneous fat layer, the operator directly recognizes the thickness of the subcutaneous fat layer by hand or checks the subcutaneous fat layer imaged through the image probe 216 provided in the first treatment handpiece 210, It is possible to calculate the exact thickness of the subcutaneous fat layer.

Next, a cartridge capable of performing the selected procedure may be selected and mounted on the first treatment handpiece 210 of the high intensity focused ultrasound treatment apparatus 10 ( S120 ). For example, when the operator wants to perform a subcutaneous fat layer reduction or removal procedure, the first cartridge 310 may be selected from the first cartridge set 300 and mounted on the first surgical handpiece 210 . Alternatively, when the operator wants to perform a face lifting or skin tightening procedure, the operator may select the second cartridge 320 from the first cartridge set 300 and mount it on the first treatment handpiece 210 .

Next, high-intensity focused ultrasound treatment may be performed using the selected cartridge (S130). For example, the operator uses the first treatment handpiece 210 to which any one of the first and second cartridges 310 and 320 is mounted, for a face lifting or skin tightening procedure and subcutaneous fat layer reduction or A removal procedure may be performed.

As described above, in the treatment method using high-intensity focused ultrasound according to an embodiment of the present invention, after selecting a treatment type for a subject to be treated, the first cartridge 310 or The second cartridge 320 may be selected, and it may be mounted on the first treatment handpiece 210 for treatment. Accordingly, the treatment method using high-intensity focused ultrasound according to the present invention prepares cartridges for various treatment purposes compatible with the treatment handpiece, and then a desired treatment during face lifting or skin tightening treatment, or reduction or removal of subcutaneous fat layer By attaching the target cartridge to the treatment handpiece and performing the treatment, it is possible to perform two or more high-intensity focused ultrasound treatments as a single device. Furthermore, it is possible to perform a procedure by mounting a cartridge for a desired treatment purpose during the treatment of gynecological diseases and vaginal contraction to be described later on the treatment handpiece. In addition, the treatment method using high-intensity focused ultrasound according to the present invention prepares cartridges for skin care having various treatment conditions compatible with the treatment handpiece and then prepares cartridges having conditions suitable for the obese state or treatment site of the subject to be treated. By attaching it to the surgical handpiece and performing a procedure to reduce the subcutaneous fat layer, a customized procedure for each patient or region can be performed.

Hereinafter, the second treatment handpiece of high-intensity focused ultrasound according to an embodiment of the present invention and the gynecological disease treatment and/or vaginal contraction procedure using the same will be described in detail. Here, the contents overlapping with the description of the above-described high intensity focused ultrasound treatment apparatus 10 may be omitted or simplified.

6 is a block diagram schematically illustrating a gynecological disease treatment and/or vaginal contraction procedure of the high-intensity focused ultrasound treatment apparatus using the second treatment handpiece and the third cartridge according to an embodiment of the present invention. Referring to FIG. 6 , the second handpiece assembly 400 and the second cartridge set 500 of the high-intensity focused ultrasound treatment apparatus 10 according to an embodiment of the present invention use high-intensity focused ultrasound to detect gynecological diseases and/or Vaginal contractions may be performed.

The gynecological diseases and vaginal contraction procedures may include procedures for treating tumors, neoplastic diseases, inflammatory diseases, menstrual disorders, sexually transmitted diseases, and sexual dysfunction. As an example, the high-intensity focused ultrasound treatment device 10 for the treatment of gynecological diseases and vaginal contraction procedures is approximately 0.5 from the skin surface of the vagina (60 in FIG. 11) to treat sexual decline or disorders due to childbirth or aging. After intentionally damaging or stimulating the skin tissue at a depth of mm to 3.0 mm, a procedure for restoring normal tissue through densification or regeneration of the skin tissue may be performed. As another example, the high-intensity focused ultrasound treatment device 10 for gynecological disease treatment and vaginal contraction surgery is the inner bone responsible for contraction of the vagina (60 in FIG. 13 ) in order to treat sexual decline or disorders due to childbirth or aging. An operation to densify or regenerate the semi-muscular fossa (Endopelvic Fascia: EPF, 70 in FIG. 13) may be performed.

Here, the HIFU may be for forming a thermal lesion (22 in FIG. 10) by focusing the ultrasound to be focused on one focus. Such a thermal lesion 22 may be a thermal focus in a high temperature state of about 60° C. or higher. Accordingly, the high-intensity focused ultrasound treatment device 10 intentionally forms a thermal lesion 22 on a tissue near the skin surface of the vagina 60, for example, a skin tissue in the range of about 0.5 mm to 3.0 mm from the vaginal skin surface. After being damaged or stimulated by skin tissue, a procedure to restore normal tissue through densification or regeneration of the skin tissue can be performed. Alternatively, the high-intensity focused ultrasound treatment device 10 is the thermal lesion ( 22) to intentionally damage or stimulate the endopelvic semi-muscular foil 70, and to restore or regenerate the endopelvic semi-muscular foil 70, thereby improving the contractile force of the vagina 60.

The high-intensity focused ultrasound treatment apparatus 10 for the treatment of gynecological diseases and/or vaginal contraction as described above includes an indicator 110, a controller 130, a database 140, an ultrasound treatment unit 514, and a second image pro part 516 , and a detector 519 .

The indicator 110 may include an imaging device for displaying information on the treatment of the gynecological disease and/or vaginal contraction procedure to the operator. The controller 130 may compare the image data captured by the second image probe unit 516 with reference data stored in the database 140 to provide the operator with information necessary for the operation. For example, in the database 140, reference data for the average thickness of a woman's vaginal muscle, the location or depth of the vaginal muscle, and the skin tissue of a specific depth for forming the thermal lesion 22 from the surface of the vaginal skin are stored. there may be Then, the second image probe 516 measures the thickness, position, or depth of the subject's vagina and transmits it to the controller 130, and the controller 130 compares the transmitted image data with the reference data. , information necessary for the procedure may be displayed on the indicator 110 .

In addition, the high-intensity focused ultrasound treatment apparatus 10 determines whether a cartridge (eg, a third cartridge: 510) containing the ultrasound treatment unit 514 is normally positioned at a preset position on the inner wall of the vagina 60 during the procedure. It may further include a detector 519 for detecting whether or not. The detector 519 is to detect the normal position of the cartridge so that the ultrasonic treatment unit 514 can accurately form the thermal lesion 22 in the skin tissue to be treated by using various sensing technologies, and the controller ( 130 may control the ultrasound treatment unit 514 by determining the detection data of the detector 519 . Reference data for determining the data sensed by the detector 519 may be further stored in the database 140 .

Subsequently, a specific embodiment of the high-intensity focused ultrasound treatment apparatus 10 as described above will be described. Here, a detailed description of the equipment body 100 and the like commonly applied to other procedures will be omitted or simplified.

7 is a perspective view showing the second treatment handpiece and the third cartridge shown in FIG. 1 , and FIG. 8 is a view for explaining the mutual coupling process of the second treatment handpiece and the third cartridge shown in FIG. 7 . 9 is a first cross-sectional view showing the coupling structure of the second surgical handpiece and the third cartridge shown in FIG. 7, and FIG. 2 is a cross section. And, FIG. 11 is a view for explaining various examples of the arrangement structure of the ultrasound treatment unit and the image probe shown in FIG. 7 .

1 and 6 to 11 , the second handpiece assembly 400 and the second cartridge set 500 of the high intensity focused ultrasound treatment apparatus 10 according to an embodiment of the present invention may be provided. .

The second handpiece assembly 400 may include a second surgical handpiece 410 and a second connection cable 420 . The second treatment handpiece 410 may be manipulated by the operator to irradiate the HIFU to the treatment subject, and may be provided in a hand-held form to improve the operator's convenience. For example, the second treatment handpiece 410 may include a second handle portion 412 so that the operator can hold the second treatment handpiece 410 . The second handle portion 412 may be provided with a second operation switch (not shown) for the operator to control the HIFU irradiation operation. The second connection cable 420 may be for electrically and physically connecting the second surgical handpiece 410 and the equipment body 100 . One end of the second connection cable 420 may be connected to the second surgical handpiece 410 , and the other end may be detachably connected to the equipment body 100 in a connecting type.

The second cartridge set 500 may be a set consisting of a plurality of cartridges. For example, the second cartridge set 500 may include third to fifth cartridges 510 , 520 , 530 and the like having the same or similar structure to each other. Each of the third to fifth cartridges (510, 520, 530) is provided as an insert to be inserted into the vagina (60) during the procedure, and HIFU to the skin tissue at a certain depth from the inner wall surface of the vagina (60) It may be provided as a HIFU irradiation unit for irradiating.

As an example, the third to fifth cartridges 510 , 520 , and 530 may have the same treatment purpose and condition. That is, the third to fifth cartridges (510, 520, 530) each have the specified HIFU irradiation intensity, depth and angle, and the size and formation position of the thermal lesion 22 formed by the HIFU under the same conditions. may be set. Accordingly, each of the third to fifth cartridges 510 , 520 , and 530 may irradiate HIFU to the inner wall of a woman's vagina under the same or similar conditions during the procedure, and form the thermal lesion 22 . The operator uses the third cartridge 310 of the third to fifth cartridges 510 , 520 , and 530 while mounting and using the third cartridge 310 on the second surgical handpiece 210 , the cycle of use of the third cartridge 310 . When the expiration of the third cartridge 310 instead of the fourth or fifth cartridge (520, 530) as a method of using, it is possible to continuously perform the treatment of the gynecological disease.

As another example, the third to fifth cartridges 510 , 520 , and 530 may have different purposes or conditions for treatment. For example, the third cartridge 510 is set to form a relatively large HIFU thermal lesion, and the fourth cartridge 520 forms a relatively small HIFU thermal lesion compared to the third cartridge 510 . can be set to do. Furthermore, the fifth cartridge 530 may be set to form a relatively small thermal lesion of HIFU compared to the fourth cartridge 520 . Alternatively, the third cartridge 510 is configured to form a thermal lesion 22 in the skin tissue of a shallow depth from the surface 62 of the lining of the vagina relatively, and the fourth cartridge 520 is the third cartridge ( It may be set to form a thermal lesion 22 in the skin tissue at a relatively deep depth from the vaginal inner wall surface 62 compared to 510 . Furthermore, the fifth cartridge 530 may be configured to form a thermal lesion 22 in the skin tissue at a greater depth from the vaginal lining representation 62 relative to the fourth cartridge 520 .

As described above, since each of the third to fifth cartridges (510, 520, 530) has a similar structure, for the detailed configurations, the third cartridge (510) as an example will be described in detail for the remaining cartridges. The description of the fields 520 and 530 will be replaced.

The third cartridge 510 may have a second cartridge body 512 in a generally cylindrical or bar shape. The second cartridge body 512 may be preferably provided in a shape and material that can be easily inserted into the vagina 60 of a woman. Accordingly, the front end of the second cartridge body 512 protrudes in a convex shape, and the circumference may be rounded as a curved curve. In addition, the second cartridge body 512 is a material that is harmless to the human body, and may be made of a material having high durability and corrosion resistance.

A window (512a) provided along the longitudinal direction of the second cartridge body (512) may be provided around the second cartridge body (512). The window 512a may be made of a material having high ultrasound transmittance so that the HIFU generated by the ultrasound treatment unit 514 provided in the third cartridge 510 can be transmitted efficiently. In addition, the perimeter of the second cartridge body 512 may be provided with a scale (512b) provided along the longitudinal direction of the second cartridge body (512). The scale (512b) may be provided for the operator to determine the degree to which the second cartridge body 512 is inserted into the vagina. In addition, an additional scale (not shown) provided along the circumferential direction of the second cartridge body 512 may be provided around the second cartridge body 512 . The additional scale may be provided for the operator to grasp the degree of rotation of the second cartridge body 512 . In this embodiment, the scale (512b) has been described as an example as a means for the operator to measure the degree of insertion of the second cartridge body 512, but for measuring the degree of insertion of the second cartridge body 512 The means can be variously changed or modified.

The third cartridge 510 may be configured to be detachably attached to the second surgical handpiece 410 . For example, a second guide part 416 for fastening with the third cartridge 510 may be provided at the front end of the second handle part 412 . As an example, the second guide part 416 may be provided as a hole or groove recessed in the rear end direction of the second handle part 412 . In addition, a portion coupled to the second guide portion 416 of the second cartridge body 512 may be provided with a fastening portion 512c having a shape corresponding to that of the second guide portion 416 . The fastening part 512c may be provided as a bar-shaped structure protruding to be inserted into the second guide part 416 . In this case, the second guide part 416 and the fastening part 512c may be coupled, separated, or rotated by a forced fitting method, a screw bolt method, or a rotatable simple coupling method. Accordingly, by inserting the fastening part 512c into the second guide part 416 , the third cartridge 510 may be mounted on the second surgical handpiece 410 . In an embodiment, the fastening part 512c may be rotatably coupled to 360° C. while being inserted into the second guide part 416 . At this time, in order to prevent the mounting state of the third cartridge 510 from being released, each of the second surgical handpiece 410 or the third to fifth cartridges 510, 520, 530 has a separate lock. A device (not shown) may be provided.

An ultrasound treatment unit 514 may be provided in the third cartridge 510 . The ultrasound treatment unit 514 may include at least one ultrasound transducer for generating the HIFU. As an example, as shown in FIGS. 9 and 10 , the ultrasound treatment unit 514 includes at least one independent transducer that forms a single thermal lesion of HIFU at a predetermined depth from the inner wall of the vagina 60 . can In this case, the independent transducer may be configured to irradiate the HIFU while moving along the window (512a). As another example, the ultrasound treatment unit 514 may include at least one transducer array for forming multiple thermal lesions of HIFU at a predetermined depth from the inner wall of the vagina 60 . That is, the transducer array may be designed such that a plurality of thermal lesions 22 are formed in one transducer body. In this case, the transducer array may be installed to be fixed in the second cartridge body 512 without being moved, or may be designed to have a smaller moving distance compared to the independent transducer.

Meanwhile, each of the third to fifth cartridges 510 , 520 , and 530 may be provided with a second image probe 516 for imaging a skin tissue to be treated. The second image probe 516 is for imaging the skin tissue in which the thermal lesion 22 is formed, and its configuration and arrangement may be variously changed. As an example, as shown in FIG. 11A , the second image probe 516 may be coupled to the center of the ultrasound treatment unit 514 and provided integrally with the ultrasound treatment unit 514 . have. In this case, the image probe unit 516 may be provided in the central region of the ultrasound treatment unit 514 so as not to interfere with the irradiation path of the high-intensity focused ultrasound of the ultrasound treatment unit 514 . As another example, as shown in FIG. 11B , the second image probe 516 may be coupled adjacent to the periphery of the ultrasound treatment unit 514 . In this case, the image probe 516 may be disposed on the same line as the moving direction of the ultrasound treatment unit 514 . In this case, the second image probe 516 sequentially inspects the skin tissue in which the thermal lesion 22 is formed while moving before the ultrasound treatment unit 516 or moving after the ultrasound treatment unit 516 during the procedure. can be imaged. As another example, as shown in FIG. 11( c ), the second image probe 516 has a long bar ( bar) may be provided. In this case, the second image probe 516 may image the skin tissue in which the thermal lesion 22 is formed without interfering with the forward and backward movement of the ultrasound treatment unit 514 . Alternatively, as shown in FIG. 11D , the second image probe 516 may be provided separately from the ultrasound treatment unit 514 . In this case, the second image probe 516 may be provided at a position capable of imaging the skin tissue to be treated without interfering with the movement path of the ultrasound treatment unit 514 . To this end, the second image probe 516 may be driven by a driver (not shown) separate from the driver that drives the ultrasound treatment unit 514 .

The second surgical handpiece 410 may further include a second actuator 418 for forward and backward movement of the ultrasound treatment unit 514 . As an example, a stepping motor or the like may be used as the second driver 418 , and its driving may be controlled by the above-described manipulation unit 120 . In addition, the second actuator 418 and the ultrasound treatment unit 514 may be connected to each other by a predetermined support. Accordingly, when the second actuator 418 is controlled by the manipulation unit 120 to move the coaxial 418a back and forth, the support coupled to the coaxial 418a moves while the ultrasonic treatment unit 514 moves back and forth. can be exercised In this way, the second driver 418 is provided to be used in common with the third to fifth cartridges 510 , 520 , and 530 , and the third to fifth cartridges 510 , 520 , 530 , respectively. of the ultrasonic treatment unit 514 may be moved back and forth.

On the other hand, the second surgical handpiece 400 is a cartridge coupled to the second surgical handpiece 400 among the third to fifth cartridges 510 , 520 , 530 , that is, in the drawing, a third cartridge ( 510) may be configured so that the operator can rotate it at a certain angle. As an example, the third cartridge 510 may be rotated at 0° C. to 360° C. by the operator's manual operation on the second treatment handpiece 410 . More specifically, the second handle portion 412 of the second treatment handpiece 410 may be composed of a fixing portion 412a and a cartridge rotating portion 412b. The fixing part 412a may be for fixing the position of the second treatment handpiece 410 when the operator holds the operator with one hand (eg, the left hand). The cartridge rotating part (412b) is rotatably provided in the fixing part (412a), so as to rotate like the third cartridge (510) coupled to the second surgical handpiece (410), the third cartridge (510) can be mutually contracted with one end of The cartridge rotating part 412b may be provided to rotate the third cartridge 510 when the operator holds the other hand (eg, the right hand) during the operation. In the second treatment handpiece 410 having the above structure, the operator holds the fixing portion 412a with the left hand and rotates the cartridge rotating portion 412b with the right hand at a predetermined angle, so that the third cartridge 510 is By rotating the third cartridge 510 by 0° to 360° based on the axis along the longitudinal direction, thermal lesions 22 can be formed on the entire inner wall of the vagina. In one embodiment, the frame fixing part 416a is coupled to the inside of the cartridge rotating part 412b, and the above-described second driver 418 may be fixed to the frame 416b coupled to the frame fixing part 416a. , thus, the frame 416b and the second driver 418 may be rotated together when the cartridge rotating part 412b rotates.

As another example, the third cartridge 510 may be automatically rotated at 0° C. to 360° C. by a simple on-off operation of the operator on the second treatment handpiece 410 . More specifically, the second actuator 418 of the second surgical handpiece 410 may rotate the third cartridge 510 by a predetermined angle with the longitudinal direction of the second cartridge body 512 as a rotation axis. . To this end, the second driver 418 may include a rotation motor for rotating the third cartridge 510 . Accordingly, the second actuator 418 rotates the third cartridge 510 in the vagina 60 during the procedure, so that the ultrasound treatment unit 514 is spaced along the inner wall of the vagina 60 at a predetermined interval. to form a thermal lesion 22 . The rotational operation of this cartridge can enable HIFU treatment for the entire inner wall of the vagina 60 in a short time. At this time, for a smooth rotation operation of the cartridge, it may be preferable that the second guide part 416 and the fastening part 512c are provided in a form that does not interfere with the rotation operation.

In addition, the second actuator 418 may move in the front-rear direction so that the ultrasound treatment unit 514 has a treatment section of approximately 10.0 mm to 120.0 mm. More specifically, the second actuator 418 may be provided as a stepping motor controlled by the manipulation unit 120, and the ultrasonic treatment unit 514 may It can be moved back and forth. At this time, the ultrasound treatment unit 514 may irradiate the HIFU while moving the range. The ultrasound treatment unit 514 is set to irradiate HIFU at regular intervals so that the thermal lesion 22 forms a plurality of dots along the same line, or so that the thermal lesion 22 forms a straight line without an interval. Can be set to irradiate HIFU.

When the length of the front-back movement of the ultrasound treatment unit 514 is less than 10.0 mm, the treatment area is small in a single treatment process, and thus the treatment time may be very long. On the other hand, considering the length and shape of the woman's vagina 60 or endosymphysis 70, etc., when the forward and backward movement distance of the ultrasound treatment unit 514 exceeds 120.0 mm, the endosymphysis ( 70), the risk of being irradiated with HIFU to other skin tissues can be very high. Therefore, the second actuator 418 is set so that the ultrasonic treatment unit 514 can be moved back and forth within the range of approximately 10.0 mm to 120.0 mm, more preferably within the range of 60.0 mm to 100.0 mm. This may be suitable for shortening the procedure time while ensuring the safety of the procedure.

In addition, a cooling fluid for cooling the heat generated by the operation of the ultrasound treatment unit 514 may be provided to each of the third to fifth cartridges 510 , 520 , and 530 . In one embodiment, each of the third to fifth cartridges 510 , 520 , 530 is provided so that coolant can be filled therein, and the coolant is circulated by a separate coolant circulation line (not shown). By doing so, it is possible to prevent overheating of the ultrasonic treatment unit 514 . To this end, when the third to fifth cartridges 510, 520, 530 are mounted on the second surgical handpiece 410, the cooling water in the third to fifth cartridges 510, 520, 530 It is connected to the cooling water circulation line, and the cooling water circulation line is connected to a cooling water storage container (not shown) inside the equipment body 100 , and may circulate the cooling water in the cooling water storage container. Meanwhile, although not shown, a circulation means such as a pump may be installed on the cooling water circulation line.

On the other hand, the third cartridge 510 is a detector 519 and the detector 519 for detecting whether the third cartridge 510 is normally positioned at a predetermined position on the inner wall of the vagina 60 during the procedure. It may further include a determination unit 130 for receiving the sensing data of the third cartridge 510 to determine whether the normal position and to control the operation conditions and the like. The determination unit 130 determines whether the third cartridge 510 is in a normal position may be determined by determining whether the third cartridge 510 is in full contact with or in close contact with the inner wall of the vagina to be treated.

More specifically, the detector 519 may include a plurality of sensors disposed at different positions of the second cartridge body 512 . For example, the detector 519 is a first sensor 519a disposed on one side of the window 512a of the second cartridge body 512 and a second sensor 519b disposed on the other side of the window 512a. may include The first sensor 519a and the second sensor 519b are detection sensors of the same condition, and detect whether or not contact with the skin surface of the vagina 60 at different positions of the second cartridge body 512 is detected. can do. An optical sensor, a pressure sensor, or the like may be used as the first and second sensors 519a and 519b.

The determination unit 130 may receive the detection data sensed by the detector 519 and determine whether the third cartridge 510 is in normal contact with or in close contact with the inner wall of the vagina 60 . As an example, the determination unit 130 may determine that when both the first sensor 519a and the second sensor 519b come into contact with the inner wall of the vagina 60 , the third cartridge 510 is the vagina 60 ) can be judged to be in close contact with the inner wall. On the other hand, if any one of the first and second sensors 519a and 519b does not come into contact with the inner wall of the vagina 60, the determination unit 130 determines that the third cartridge 510 moves the inner wall of the vagina. It can be judged to be in abnormal contact or close contact with The determination result as described above may be displayed at the time of display 110 or the like so that an operator (not shown) can recognize it.

In addition, the determination unit 130 may control the treatment conditions of the third cartridge 510 based on the detection result of the detector 519 . For example, when both the first sensor 519a and the second sensor 519b come into contact with the inner wall of the vagina 60, the determination unit 130 automatically performs HIFU irradiation so that the ultrasound treatment unit 514 is performed. ) and the second driver 418 may be controlled. In addition, when the determination unit 130 does not contact the inner wall of the vagina 60 in any one of the first and second sensors 519a and 519b, the HIFU irradiation of the ultrasound treatment unit 514 occurs By controlling the third cartridge 510 so that it does not occur, it is possible to prevent the formation of thermal lesions 22 other than a predetermined skin tissue.

Here, the first and second sensors 519a and 519b may be preferably disposed on an imaginary line 80 crossing the center of the window 512a. That is, as described above, the HIFU is irradiated through the window 512a, and whether the third cartridge 510 is in a normal position is sensed by both the first and second sensors 519a and 519b. condition, it can be accurately determined whether the window 512a is completely in close contact with the vagina 60 that the first and second sensors 519a and 519b are positioned on the virtual line 80 have. If the first and second sensors 519a and 519b are disposed outside the imaginary line 80 , in detecting whether the third cartridge 510 is normally positioned inside the vagina 60 , Accuracy may decrease.

In order to improve the accuracy of determining the normal position of the third cartridge 510, a plurality of sensors may be added in addition to the first and second sensors 519a and 519b. Alternatively, it is not limited to the arrangement of the first and second sensors 519a and 519b, and the normal position of the third cartridge 510 may be determined as various arrangements. However, in consideration of the structure of the third cartridge 510 and the position during the procedure, it may be important that the window 512a is completely in close contact with the inner wall of the vagina 60, and the detector 519 accurately detects this. It may be desirable to optimize for sensing.

On the other hand, the detector 519 and the determination unit 130 may detect the insertion depth of the third cartridge 510 into the vagina 60 to be recognized by the operator. More specifically, the detector 519 may further include third sensors 519c arranged in a line along the longitudinal direction of the second cartridge body 512 . The third sensors 519c may be disposed to be spaced apart from each other at regular intervals on the same straight line that crosses the longitudinal direction of the second cartridge body 512 . Since the third sensors 519c are spaced apart in a specific unit, an arrangement interval of the third sensors 519c may be a unit of measurement of the insertion depth of the third cartridge 510 . Each of the third sensors 519c may be implemented as an optical sensor, a pressure sensor, etc. of the same specification. Accordingly, when the third cartridge 510 is inserted into the vagina 60 , the third sensors 519c sequentially come into contact with the vagina 60 to detect whether they are in contact, and the determination unit 130 may analyze the sensed data transmitted from the third sensors 519c and display it on the indicator 110 so that the operator can recognize the inserted depth of the third cartridge 510 .

The high-intensity focused ultrasound treatment apparatus 10 according to the embodiment of the present invention described above is provided in the third cartridge 510, the third cartridge 510 for irradiating HIFU by being inserted into the vagina 60 of the operator. An image probe 516 for imaging a skin tissue of a certain depth from the skin surface of the vagina 60 as a target, and an image data received from the image probe 516 to determine the treatment conditions of the ultrasound treatment unit 514 It may include a controller 130 to control. In this case, the high-intensity focused ultrasound treatment apparatus 10 confirms the skin tissue to be treated, for example, the thickness or condition of the vaginal muscle to the operator, and as a suitable treatment condition, the high-intensity focusing of the ultrasound treatment unit 514 Ultrasound irradiation conditions can be adjusted. Accordingly, the apparatus for high-intensity focused ultrasound treatment according to the present invention changes the irradiation condition of the thermal lesion by comparing the image data with reference data after imaging the skin tissue inside the vagina to form a thermal lesion during the procedure, thereby changing the irradiation condition of the thermal lesion, gynecological disease may improve the safety of treatment and/or vaginal contraction procedures.

In addition, the high-intensity focused ultrasound treatment apparatus 10 according to an embodiment of the present invention is a third cartridge 510 that is inserted into the operator's vagina 60 to irradiate HIFU, the third cartridge 510 is the vagina ( 60) by receiving the sensor 519 for detecting whether or not contact with the skin tissue and the detection data of the sensor 519 to determine whether the third cartridge 510 is normally positioned, and the operation of the third cartridge 510 It may include a determination unit 130 for controlling the. In this case, the HIFU treatment device 10 determines whether the third cartridge 510 inserted into the vagina 60 during the procedure was normally positioned at a predetermined position, and accurately thermal lesions on the desired skin tissue ( 22) can be formed. Accordingly, the high-intensity focused ultrasound treatment device according to the present invention performs the procedure after determining whether the cartridge inserted into the vagina is normally positioned inside the vagina during the procedure, so that the thermal lesions are accurately irradiated to the preset skin tissue, so that the gynecological disease It may improve the safety of treatment and vaginal contraction procedures.

In addition, the high-intensity focused ultrasound treatment apparatus 10 according to the embodiment of the present invention enables the operator to move the ultrasound treatment unit 514 forward and backward on the second treatment handpiece 410 as well as the ultrasound treatment unit ( 514) may be rotated at a predetermined angle from 0° to 360° to form the thermal lesions 22 on the entire inner wall of the vagina 60. In this case, since the operator can irradiate the thermal lesions 22 over the inner wall of the vagina 60 only by a simple manipulation of the second treatment handpiece 410, the treatment of gynecological diseases and/or vaginal contraction procedures It is possible to shorten the treatment time and improve the treatment efficiency. Accordingly, the high-intensity focused ultrasound treatment apparatus according to the embodiment of the present invention allows the operator to form thermal lesions on the entire inner wall of the vagina while simultaneously performing the forward and backward motions and rotational motions of the ultrasound treatment unit 514 as a simple manipulation of the treatment handpiece. Therefore, it is possible to shorten the operation time of the treatment of gynecological diseases and/or vaginal contraction procedures, and improve the operation efficiency.

In addition, the high-intensity focused ultrasound treatment apparatus 10 according to the embodiment of the present invention described above uses HIFU to directly restore and can be played In this case, the high-intensity focused ultrasound treatment device 10 has less pain and less bleeding compared to the case of burning skin tissue by irradiating a laser directly to the inner wall surface of the vagina 60 like the existing CO ₂ laser treatment equipment. Because of this, pain and side effects may occur even after the procedure, which may not cause inconvenience to daily life. Accordingly, the high-intensity focused ultrasound treatment device for the treatment of gynecological diseases and/or vaginal contractions according to the present invention can non-invasively regenerate or restore the endopelvic semimuscular muscle responsible for vaginal contraction using high-intensity focused ultrasound. Compared to a laser device that directly burns the inner wall, there is less pain and less bleeding, so you can live a normal life even after the procedure.

Subsequently, a method of high-intensity focused ultrasound treatment for gynecological disease treatment and vaginal contraction surgery according to an embodiment of the present invention will be described in detail. Here, the contents overlapping with the description of the high intensity focused ultrasound treatment apparatus 10 according to the embodiment of the present invention described above may be omitted or simplified.

12 is a flowchart for explaining a gynecological disease and a vaginal contraction procedure according to an embodiment of the present invention, and FIG. 13 is a view for explaining a gynecological disease and a vaginal contraction procedure according to an embodiment of the present invention.

12 and 13, it is possible to prepare cartridges having different treatment conditions from each other (S210). For example, preparing the cartridges may include preparing the third to fifth cartridges 510 , 520 , and 530 having different irradiation conditions of high intensity focused ultrasound. As an example, the third to fifth cartridges 510 , 520 , and 530 may have different sizes of thermal lesions of high-intensity focused ultrasound. As another example, the third to fifth cartridges 510 , 520 , and 530 may have different depths of irradiation of high-intensity focused ultrasound, that is, depths of thermal lesion generation.

By checking the quality of the subject to be treated, it is possible to select a cartridge suitable for the subject from among the cartridges (S220). For example, the operator (not shown) can determine the quality and shape of the subject to be treated (not shown), and select one set as a suitable treatment condition from among the third to fifth cartridges (510, 520, 530). have. Here, in order to determine the condition of the subject to be treated, after the operator combines an arbitrary cartridge with the second treatment handpiece 410 , the skin tissue condition imaged by the second image probe 516 is displayed through the display unit 110 . This can be done by checking.

If the operator has selected the third cartridge 510, the selected third cartridge (hereinafter, the selected cartridge, 510) may be mounted on the treatment handpiece (S230). For example, the operator may mount the selected cartridge 510 to the second treatment handpiece 410 . At this time, the operator inserts the fastening portion 512c of the selected cartridge 510 into the second guide portion 416 of the second treatment handpiece 410, and inserts the second treatment handpiece 410 into the second treatment handpiece 410. The selected cartridge 510 may be engaged.

Next, the mounted cartridge 510 may be inserted into the vagina 60 of the subject to be treated (S240). More specifically, the operator may insert the selected cartridge 510 into the vagina 60 to a desired depth. At this time, for smooth insertion of the selected cartridge 510 and efficient ultrasound treatment, an auxiliary agent such as ultrasound gel may be applied to the selected cartridge 510 for use.

When the selected cartridge 510 is normally inserted into the vagina 60, the skin tissue inside the vagina 60 to be treated may be imaged (S250). More specifically, the second image probe 516 provided inside the cartridge 510 inserted into the vagina 60 transmits image ultrasound toward the skin tissue inside the vagina 60 where the high-intensity focused ultrasound is irradiated. can be investigated The ultrasound image may be transmitted through the window 512a provided in the cartridge 510 . The image data by the image probe 516 is transmitted to the controller 130, so that the operator can recognize the skin tissue inside the vagina 60, the skin tissue state and information about the treatment conditions suitable for it can be displayed. There is (S260). The display of such information may be guided to the operator through the indicator 110 .

It is possible to adjust the treatment conditions to suitable treatment conditions (S280). For example, the controller 130 may compare the image data with the reference data to determine whether the thickness of the muscle of the vagina 60 is thicker or thinner than a preset thickness, or the location of the muscle. If the thickness of the muscle of the vagina 60 is larger than the upper and lower width of the thermal lesion 22, the controller 130 determines that the upper and lower width of the thermal lesion 22 is greater than the thickness of the muscle of the vagina 60. By controlling the ultrasound treatment unit 514 to be thin, it is possible to prevent the thermal lesion 22 from being formed in tissues other than the muscles of the vagina 60 . Alternatively, when the thickness of the muscle of the vagina 60 is thinner than a specific thickness, the controller 130 controls the ultrasound treatment unit 514 to reduce the intensity or intensity of the high-intensity focused ultrasound, so that the vagina ( 60) can prevent muscle damage. In addition, the controller 130 may control the second actuator 418 so that the position of the ultrasound treatment unit 514 is aligned so that the thermal lesion 22 can be accurately formed in the skin tissue to be treated. may be In the control of the treatment conditions as described above, the controller 130 may automatically control the ultrasound treatment unit 514 or the second driver 418 by comparing and determining the reference data in the database 140 . Alternatively, the controller 130 displays an accurate image on the display 110 and guides suitable treatment conditions, but the operator manipulates the manipulation unit 120 to change the treatment conditions to the ultrasound treatment unit 514 and the It may be achieved by adjusting the condition of the second driver 418 .

And, if the treatment conditions are adjusted, while rotating the mounted cartridge 510 at a certain angle, it is possible to perform gynecological disease treatment and/or vaginal contraction surgery (S280). For example, when the position of the second treatment handpiece 410 is determined, the operator appropriately manipulates the operation unit 120 and the second operation switch 414, etc., and focuses the high intensity by the ultrasound treatment unit 514 The ultrasonic thermal lesion 22 may be formed at a predetermined position in the skin tissue inside the vagina 60 . At this time, as the selected cartridge 510 is linearly reciprocated and rotated by the second actuator 418 or the operator's manual operation, a plurality of the thermal lesions 22 follow the inner circumference of the vagina 60 . It can be formed three-dimensionally.

More specifically, the operator holds and fixes the fixing portion 412a of the second treatment handpiece 410 with one hand, and then uses the other hand to hold the operation switch provided in the second treatment handpiece 410 ( not shown) may be turned on/off or a foot switch may be operated. Accordingly, while the ultrasonic treatment unit 514 in the selected cartridge 510 moves forward along the longitudinal direction of the selected cartridge 510, thermal lesions 22 along a virtual first line in the vaginal inner wall skin tissue. can be formed. When the formation of the thermal lesions 22 according to the forward and backward movement is completed, the operator may rotate the cartridge rotating part 412b of the second surgical handpiece 410 by a predetermined angle with the other hand. According to the rotation of the cartridge rotating part 412b, the selected cartridge 510 may be rotated at a predetermined angle along the rotation direction R with respect to the mandrel of the selected cartridge 510. Then, the operator operates the operation switch or the foot switch, so that the ultrasound treatment unit 514 is parallel to the first line and the thermal lesions 22 along a second line spaced apart from the first line by a predetermined distance. can form.

By repeating the above sequence, the thermal lesions 22 are formed in the form of a plurality of dots spaced apart from each other along the same line at a predetermined depth throughout the internal skin tissue of the vagina 60 . can be Accordingly, the specific skin tissue inside the vagina 60 is appropriately damaged and stimulated by the thermal lesions 22 , and the damaged skin tissue is restored and regenerated, so that the skin tissue of the vagina 60 is regenerated. Or, the inner bone semi-geunbak 70 may be densified.

On the other hand, before the step (S290) of performing the gynecological disease treatment and/or vaginal contraction procedure, the step of determining whether the selected cartridge 510 is normally positioned on the inner wall of the vagina 60 to be treated will be added. may be More specifically, the determination unit 130 receives the sensed data from the first and second sensors 519a and 519b, and both the first and second sensors 519a and 519b normally perform the quality 60 ), it can be determined whether it has been detected as being in contact with the skin surface. In this case, the determination unit 130 may determine that the selected cartridge 510 is normally located inside the vagina 60 . On the other hand, the determination unit 130 receives the sensed data from the first and second sensors 519a and 519b, and any one of the first and second sensors 519a and 519b ), it can be determined that the selected cartridge 510 is abnormally located inside the vagina 60 . On the other hand, the determination unit 130 is transmitted from a sensor that detects contact with the inner wall of the vagina 60 among the third sensors 519c while the selected cartridge 510 is inserted into the vagina 60 . By sensing the sensed data, the insertion depth of the selected cartridge 510 may be measured. As described above, the information measured through the first to third sensors 519a, 519b, and 519c is aggregated, so that a determination of the normal position of the selected cartridge 510 can be made. Accordingly, the determination unit 130 may display the abnormal position of the cartridge 510 to the outside through a display means such as the indicator 110 so that the operator can recognize it. As described above, when the selected cartridge 510 is normally positioned inside the vagina 60, gynecological disease treatment and vaginal contraction surgery can be performed.

The high-intensity focused ultrasound treatment method according to the embodiment of the present invention as described above confirms to the operator the thickness or condition of the skin tissue to be treated, for example, the vaginal muscle, etc. can be adjusted. Accordingly, the high-intensity focused ultrasound treatment method according to the present invention compares the image data of the skin tissue inside the vagina to form a thermal lesion during the procedure with the reference data, and changes the treatment condition of the high-intensity focused ultrasound to a suitable treatment condition, It may improve the safety of treatment of gynecological diseases and/or vaginal contraction procedures.

In addition, the high-intensity focused ultrasound treatment method according to an embodiment of the present invention is whether the third cartridge 510 inserted into the operator's vagina 60 to irradiate HIFU is normally in close contact with the skin tissue of the vagina 60 By determining , the third cartridge 510 may be operated only when the third cartridge 510 is normally positioned. In this case, the high-intensity focused ultrasound treatment method determines whether the third cartridge 510 inserted into the vagina 60 is normally positioned at a preset position during the procedure, and the thermal lesions 22 are precisely in the desired skin tissue. ), it is possible to prevent the thermal lesions 22 from being formed other than a predetermined skin tissue. Accordingly, the high-intensity focused ultrasound treatment method according to the present invention performs the procedure after determining whether the cartridge inserted into the vagina is normally positioned inside the vagina during the procedure, so that the thermal lesions are accurately irradiated to the preset skin tissue, thereby gynecological disease It may improve the safety of treatment and vaginal contraction procedures.

In addition, the high-intensity focused ultrasound treatment method according to an embodiment of the present invention selects the cartridge 510 of the desired treatment condition from the second cartridge set 500 by grasping the condition of the subject to be treated, and uses this as the second treatment handpiece. It can be operated by attaching it to the 410 . Accordingly, in the high-intensity focused ultrasound treatment method according to an embodiment of the present invention, cartridges having treatment conditions suitable for the operator's vaginal condition are prepared compatible with the treatment handpiece, and then the selected cartridge is mounted on the treatment handpiece. Therefore, it is possible to perform a patient-customized procedure by replacing the cartridge as a single device.

In addition, in the high-intensity focused ultrasound treatment method according to an embodiment of the present invention, the operator not only moves the ultrasound treatment unit 514 in the cartridge mounted on the second treatment handpiece 410 with a simple operation, but also moves back and forth from 0° to 360°. The thermal lesions 22 may be evenly formed over the entire inner wall of the vagina 60 while rotating at a predetermined angle within the range. Accordingly, in the high-intensity focused ultrasound treatment method according to the embodiment of the present invention, the operator can form thermal lesions on the entire inner wall of the vagina while simultaneously performing the forward and backward motion and rotational motion of the ultrasound treatment unit as a simple manipulation of the treatment handpiece. It is possible to shorten the treatment time of the disease treatment and/or vaginal contraction procedure, and improve the procedure efficiency.

In addition, the high-intensity focused ultrasound treatment method according to the embodiment of the present invention described above can directly restore and regenerate the endosymphysis 70, which is actually responsible for vaginal contraction, not the surface of the vagina 60, using HIFU. have. Accordingly, the high-intensity focused ultrasound treatment method according to the present invention can non-invasively regenerate or restore the endopelvic semimuscular muscle responsible for vaginal contraction using high-intensity focused ultrasound, so it is less painful than a laser device that directly burns the vaginal lining. Since there is little bleeding and no bleeding, you can lead a normal daily life after the procedure.

Although specific embodiments of the high-intensity focused ultrasound treatment apparatus and the treatment method thereof have been described so far according to the present invention, it is apparent that various implementation modifications are possible without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the described embodiments, and should be defined by the claims and equivalents as well as the claims to be described later. It should be understood that the above-described embodiments are illustrative in all respects and not restrictive, and the scope of the present invention is indicated by the claims to be described later rather than the detailed description, and the meaning and scope of the claims and their equivalents All changes or modifications derived from the concept should be construed as being included in the scope of the present invention.

10: High-intensity focused ultrasound treatment device
12, 22: thermal lesion
20: subcutaneous fat layer
30, 50: HIFU lesion
40: skin tissue to be treated
60: vagina
70: endoskeletal half muscle
80: virtual line
100: equipment body
110: indicator
120: control panel
130: controller
140: database
200: first handpiece assembly
210: first treatment handpiece
212: first handle portion
212a: first operation switch
214: first guide unit
216: first image probe
218: first driver
220: first connection cable
300: first cartridge set
310: first cartridge
312: first cartridge body
314: therapeutic transducer
316: support
320: second cartridge
400: second handpiece assembly
410: second treatment handpiece
412: second handle part
414: second operation switch
416: second guide unit
418: second actuator
420: second connection cable
500: second cartridge set
510: third cartridge
512: second cartridge body
514: Ultrasound treatment unit
516: second image probe
519 : Detector
520: fourth cartridge
530: fifth cartridge

Claims (16)

a surgical handpiece used as a handle;
It is made in the shape of a bar so that it can be inserted into the vagina of the subject to be treated, is detachably provided to the treatment handpiece, and an ultrasound treatment unit that generates High Intensity Focused Ultrasound (HIFU) is provided inside cartridge;
a driver for driving the ultrasound treatment unit so that the ultrasound treatment unit moves back and forth along the longitudinal direction of the cartridge; and
A controller for controlling the irradiation conditions of the high-intensity focused ultrasound,
The ultrasound treatment unit,
According to the irradiation conditions of the high-intensity focused ultrasound controlled by the controller to improve the contractile force of the vagina, the ultrasound is focused on the vaginal muscle so as to be focused in one focus to form a thermal lesion in the vagina. restoring or regenerating the vaginal muscles by damaging the muscles or stimulating the vaginal muscles;
The actuator is
Move the ultrasound treatment unit by a selected length within a length range set according to the length and shape of the vagina to shorten the procedure time and ensure safety of the procedure,
The ultrasound treatment unit,
While moving by the actuator, it is possible to irradiate the high-intensity focused ultrasound so that a plurality of thermal lesions are formed to be spaced apart from each other along one line or the thermal lesions are continuously formed along one line,
The cartridge further comprises a sensor for determining whether the cartridge is in contact with the surface of the vaginal skin,
The detector is
a first sensor disposed on one side of the cartridge to detect whether a contact is made with the first position of the query; and
and a second sensor disposed on the other side of the cartridge to detect whether a second position of the vagina is in contact with a second position different from the first position. The method of claim 1,
Further comprising an image probe for imaging the skin tissue of a certain depth from the surface of the vaginal skin,
The controller is a high-intensity focused ultrasound treatment apparatus for adjusting the irradiation condition of the high-intensity focused ultrasound of the ultrasound treatment unit in consideration of the skin tissue measured by the image probe. 3. The method of claim 2,
the image probe images the thickness of the vaginal muscle,
The controller is a high-intensity focused ultrasound treatment apparatus for controlling the irradiation condition of the high-intensity focused ultrasound of the ultrasound treatment unit in consideration of the thickness of the vaginal muscle measured by the image probe. 3. The method of claim 2,
The image probe is coupled to the ultrasound treatment unit to move forward and backward together with the ultrasound treatment unit. 3. The method of claim 2,
The cartridge is:
Cartridge body having a bar shape; and
and a window provided in the longitudinal direction of the cartridge around the cartridge body so that the high-intensity focused ultrasound generated from the ultrasound treatment unit is transmitted to the outside,
The image probe irradiates ultrasound to the vagina through the window to image the thickness of the vaginal muscles. delete 3. The method of claim 2,
The high-intensity focused ultrasound treatment apparatus further comprising an indicator for externally displaying the imaging data by the image probe. 3. The method according to claim 1 or 2,
The treatment handpiece comprises a cartridge rotating part for rotating the cartridge about the mandrel of the cartridge,
The cartridge rotating part is provided to rotate together with the cartridge,
The treatment handpiece is a high-intensity focused ultrasound treatment device including a fixing unit to which the cartridge rotating unit is rotatably coupled. 3. The method of claim 2,
The controller compares the image data measured by the image probe with preset reference data so as to prevent the ultrasonic treatment unit from being irradiated with the high-intensity focused ultrasound when the thickness of the vaginal muscle is out of the preset vaginal thickness. Controlled high-intensity focused ultrasound treatment device. 3. The method of claim 2,
The controller compares the image data measured by the image probe with preset reference data so as to form a thermal lesion made of the high-intensity focused ultrasound within the upper and lower widths of the thickness of the vaginal muscle. A high-intensity focused ultrasound treatment device that controls the depth of irradiation.
delete delete delete delete delete delete

Images