Sweat gland testing device

Abstract

To provide an ultrasonic image diagnostic device that visualizes a subcutis state and displays it, and a treatment device for tragomaschalia or hyperhidrosis equipped with the ultrasonic image diagnostic device.SOLUTION: An ultrasonic image diagnostic device includes an ultrasonic probe and a cross section echo image generation device for generating a cross section echo image by a scan signal from the ultrasonic probe. The cross section echo image generation device displays a cross section echo image on the basis of a scan signal by the scanning of the ultrasonic probe on the skin surface of a living body. The cross section echo image includes information on a state of the skin or below of the living body. The information on the state of the skin or below of the living body includes information on a distribution state of sweat glands present in the range of 0.5-3.5 mm below the skin. The ultrasonic probe is of a linear probe type with the number of elements being 128 or more and the drive frequency being 20 MHz or more and less than 40 MHz.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a sweat gland inspection device that is effective in preoperative diagnosis, postoperative diagnosis, and recurrence diagnosis of eccrine glands and apocrine glands that are sweat glands present under the skin of the human body, and that visualizes and displays information regarding the distribution, density, location, and depth, or the diagnosis, location, spread, depth, and infiltration of benign and malignant skin tumors, for example, an ultrasound imaging diagnostic device for obtaining information on the distribution range of sweat glands when treating using a treatment device for axillary odor or hyperhidrosis. [Background technology]

[0002] Eccrine glands are sweat glands found in the skin of almost all parts of the body, with particularly large numbers on the head, face, and back. Most of the sweat produced by the human body comes from these eccrine glands. Sweat from these glands is mostly water, with salt being the main component. In contrast, apocrine glands are found particularly in the armpits, ears, areola, and genitals, and the sweat produced by apocrine glands is 70-80% water and contains proteins, lipids, ammonia, etc. Unpleasant odors such as axillary odour are caused by sweat from apocrine glands.

[0003] Because excessive sweat secretion from these apocrine and eccrine glands can cause axillary hyperhidrosis (body odor) and hyperhidrosis, treatment methods for suppressing excessive sweating have been studied. For example, Patent Document 1 discloses a sweat suppression device that includes an electrode needle and a cooling unit with a through-hole through which the electrode needle can be inserted, and that brings the cooling unit into close contact with the skin surface of a living body, causes the electrode needle to protrude from the cooling unit, and energizes it to heat the tip of the electrode needle, thereby destroying the sweat glands at the tip of the electrode needle. Destruction of the sweat glands by such a sweat suppression device can suppress excessive sweat secretion from apocrine or eccrine glands.

[0004] The sweat glands that are the target of destruction by the sweat suppression device are located at various depths from the dermis to the subcutaneous tissue, but the thickness of the dermis and subcutaneous tissue varies not only between individuals but also between different parts of the body. Therefore, to reliably destroy the sweat glands, it is necessary to heat the entire depth direction from the dermis to the subcutaneous tissue while gradually changing the puncture depth of the electrode needle according to the thickness of the dermis and subcutaneous tissue.

[0005] However, conventional anti-wrinkle devices are not equipped with a means for detecting the distribution and depth of apocrine and eccrine glands in a living body (including the dermis and subcutaneous tissue; the same applies below). As a result, it is not possible to determine the range and depth to be heated by the electrodes, and as a result, there is a risk of overheating or insufficient heating of the living body. Therefore, there is a demand for a means for determining the location and depth of apocrine and eccrine glands in advance. Furthermore, surgical procedures such as excision surgery and removal surgery have been performed without determining the range and depth.

[0006] In addition, due to the lack of a diagnostic method for skin cancer currently available, tissue is scraped from the surface of the skin, and once the cancerous tissue is reached, the pathological tissue is diagnosed and treatment for skin cancer is determined. If no skin cancer is found at a shallower location, a primitive diagnostic method is adopted in which the tissue is scraped deeper to determine whether or not skin cancer is present. Therefore, there is a need for the development of a means to visualize and display the state of the tissue below the surface of the skin in the depth direction, thereby enabling confirmation of the location, extent, and depth of invasion of the cancer. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Japanese Patent Application Laid-Open No. 2017-086096 [Patent Document 2] Japanese Patent Application Laid-Open No. 2014-247054 Summary of the Invention [Problem to be solved by the invention]

[0008] Meanwhile, methods and systems for ultrasonic tissue processing using an ultrasonic probe are known as means for visualizing tissues inside a living body. For example, Patent Document 2 discloses a method for performing a facelift by contracting the facial fascia (SMAS: Superficial Musculo-Aponeurotic System) using an ultrasonic imaging / treatment probe, in which the ultrasonic imaging / treatment probe visualizes and displays a cross-sectional structure of the subcutaneous tissue, including the SMAS, and supplies ultrasonic energy from the ultrasonic imaging / treatment probe to heat and contract the SMAS, thereby performing a facelift. Furthermore, paragraphs

[0051] to

[0071] of Patent Document 2 also disclose the use of an ultrasonic imaging / treatment probe to visualize and display a cross-sectional structure of the subcutaneous tissue, including sweat glands such as apocrine glands and eccrine glands, and the supply of ultrasonic energy from the ultrasonic imaging / treatment probe to treat these tissues.

[0009] Furthermore, in Patent Document 2, paragraph

[0062] states that "the imaging transducer may be operated at a frequency of approximately 2 MHz to 75 MHz or more, and the treatment energy is introduced at a frequency of approximately 500 kHz to 15 MHz, typically 2 MHz to 25 MHz." Paragraph

[0064] also states that "For example, as shown in FIG. 2B, according to a typical embodiment, a typical treatment method and system is configured to first image a region 222 in the region of interest 206, and then display that region 224 on display 208 to facilitate identification of the treatment area and surrounding structures, such as identifying sweat glands 230." Furthermore, FIGS. 2P and 2Q show examples of sweat glands being displayed on a display.

[0010] Thus, although Patent Document 2 does describe the display of sweat glands using an ultrasound imaging / treatment probe, the description in Patent Document 2 does not clarify what configuration of ultrasound imaging / treatment probe to use, what frequency to use for imaging sweat glands, or how to operate and display the ultrasound imaging / treatment probe. Because eccrine glands and apocrine glands are located at a depth of only a few millimeters subcutaneously, for example, 0.5 to 3.5 mm, it has been difficult to obtain clear cross-sectional echo images of sweat glands using conventional ultrasound probes, and to the inventor's knowledge, there have been no known examples of obtaining cross-sectional echo images of sweat glands such as those shown in Figures 2P and 2Q of Patent Document 2 using an ultrasound probe prior to the filing of the present patent application.

[0011] The present invention has been made to solve the problems of the prior art as described above. That is, an object of the present invention is to provide a sweat gland testing device that uses an ultrasonic probe to visualize and display eccrine glands and apocrine glands, which are sweat glands present under the skin of the human body, or malignant skin tumors, and obtains information about the position, distribution, and depth of the detected sweat glands. [Means for solving the problem]

[0012] A sweat gland inspection device according to a first aspect of the present invention comprises an ultrasonic probe, a cross-sectional echo image generating device that generates a cross-sectional echo image based on a scanning signal from the ultrasonic probe, and an analyzer that analyzes the cross-sectional echo image from the cross-sectional echo image generating device to recognize a subcutaneous condition, wherein the ultrasonic probe has a substantially rectangular contact surface having long and short sides and is capable of scanning at least along the long side direction and along the short side direction, and the cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal including scanning at least along the long side direction and along the short side direction by the ultrasonic probe on the epidermal surface of a living body before treatment, after injection of an anesthetic agent, and after treatment, and the cross-sectional echo image generating device: (a) generating a pre-treatment longitudinal cross-sectional echo image for determining the distribution of subcutaneous sweat glands before treatment, the pre-treatment longitudinal cross-sectional echo image having a display range along the longitudinal direction wider than the length of the short side direction, from scanning signals along the longitudinal direction including scanning signals obtained by scanning along the longitudinal direction of the ultrasound probe from the reference point in a direction from the hand to the armpit; (b) generating a pre-treatment short-side cross-sectional echo image from a scan signal obtained by scanning the epidermis surface of the living body along the short side direction with the ultrasonic probe before treatment, the pre-treatment image representing the distribution of sweat glands under the skin across the long side length range; (c) the analysis device uses the pre-treatment long-axis cross-sectional echo image and the pre-treatment short-axis cross-sectional echo image generated by the cross-sectional echo image generating device to The pre-treatment long-side cross-sectional echo image is used to determine the distribution of subcutaneous sweat glands before treatment, which has a display range along the long side direction that is wider than the short-side length, and the pre-treatment short-side cross-sectional echo image is used to grasp the distribution of subcutaneous sweat glands over the long-side length range before treatment, By analyzing the distribution of the sweat glands by image recognition, information on the distribution range of the sweat glands is obtained, The information on the distribution range of the sweat glands obtained by the analysis in the analysis device includes at least (1) Cross-sectional ultrasound image information on the distribution of sweat glands located within the subcutaneous tissue between 0.5 and 3.5 mm, (2) Cross-sectional echographic information on the location of sweat glands located between 0.5 and 3.5 mm below the skin surface, and (3) Information on cross-sectional ultrasound images regarding the depth of sweat glands located within the subcutaneous tissue, between 0.5 and 3.5 mm Contains, The ultrasonic probe is characterized by being a linear probe type having 128 or more elements and a driving frequency of 20 MHz or more.

[0013] A sweat gland inspection device according to a second aspect of the present invention is a sweat gland inspection device comprising an ultrasonic probe, a cross-sectional echo image generating device that generates a cross-sectional echo image based on a scanning signal from the ultrasonic probe, and an analyzer that recognizes a subcutaneous condition by analyzing the cross-sectional echo image from the cross-sectional echo image generating device, wherein the ultrasonic probe has a substantially rectangular contact surface having long and short sides and is capable of scanning at least along the long side direction and along the short side direction, and the cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal including scanning at least along the long side direction and along the short side direction by the ultrasonic probe on the epidermal surface of a living body before treatment, after injection of an anesthetic agent, and after treatment, and the cross-sectional echo image generating device: (a2) A reference point is first determined, and a post-injection long-side cross-sectional echo image is generated from the scanning signals along the long side, including scanning signals obtained by scanning along the long side of the ultrasonic probe on the epidermis surface of a living body after an anesthetic has been injected, from the scanning signals along the long side, including scanning signals obtained by scanning from the reference point along the long side of the ultrasonic probe in a direction from the hand to the armpit, to determine the distribution of sweat glands after subcutaneous injection, the post-injection long-side cross-sectional echo image having a display range along the long side that is wider than the length in the short side direction; (b2) generating a post-injection cross-sectional echo image in the short side direction from a scanning signal obtained by scanning the surface of the epidermis of the living body along the short side direction of the ultrasonic probe after injecting an anesthetic agent, the cross-sectional echo image capturing the distribution of sweat glands over the long side length range after subcutaneous injection; (c2) In the analysis device, using the post-injection long-side cross-sectional echo image and the post-injection short-side cross-sectional echo image generated by the cross-sectional echo image generating device, The post-injection long-side cross-sectional echo image is used to determine the distribution of sweat glands after subcutaneous injection having a display range wider than the short-side length in the direction along the long side, and the post-injection short-side cross-sectional echo image is used to grasp the distribution of sweat glands over the long-side length range after subcutaneous injection. The distribution of sweat glands is analyzed by image recognition to obtain information on the distribution range of sweat glands, and the information on the distribution range of sweat glands obtained by analysis in the analysis device includes at least (1) Cross-sectional ultrasound image information on the distribution of sweat glands located within the subcutaneous tissue between 0.5 and 3.5 mm, (2) Cross-sectional echographic information on the location of sweat glands located between 0.5 and 3.5 mm below the skin surface, and (3) Information on cross-sectional ultrasound images regarding the depth of sweat glands located within the subcutaneous tissue, between 0.5 and 3.5 mm Contains, The ultrasonic probe is characterized by being a linear probe type having 128 or more elements and a driving frequency of 20 MHz or more.

[0014] A sweat gland inspection device according to a third aspect of the present invention is a sweat gland inspection device comprising an ultrasonic probe, a cross-sectional echo image generating device that generates a cross-sectional echo image based on a scanning signal from the ultrasonic probe, and an analyzer that recognizes a subcutaneous condition by analyzing the cross-sectional echo image from the cross-sectional echo image generating device, wherein the ultrasonic probe has a substantially rectangular contact surface having long sides and short sides and is capable of scanning at least along the long side direction and along the short side direction, and the cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal including scanning at least along the long side direction and along the short side direction by the ultrasonic probe on the epidermal surface of a living body before treatment, after injection of an anesthetic agent, and after treatment, and the cross-sectional echo image generating device: (a3) generating a post-treatment short-side cross-sectional echo image from a scanning signal obtained by scanning the epidermis surface of the living body along the short side direction with the ultrasonic probe after treatment, the post-treatment image representing the distribution of sweat glands under the skin over the long side length range; (b3) In the analysis device, using the post-treatment long-side cross-sectional echo image and the post-treatment short-side cross-sectional echo image generated by the cross-sectional echo image generating device, (c3) The post-treatment long side cross-sectional echo image is used to determine the distribution of subcutaneous sweat glands after treatment having a display range wider than the short side length in the direction along the long side, and the post-treatment short side cross-sectional echo image is used to grasp the distribution of subcutaneous sweat glands over the long side length range after treatment, and the post-treatment distribution of sweat glands is analyzed by image recognition to obtain information on the distribution range of sweat glands after treatment. Thus, the distribution of sweat glands over the long side length range after subcutaneous injection is grasped, and the distribution of sweat glands is analyzed by image recognition to obtain information on the distribution range of sweat glands, and the information on the distribution range of sweat glands obtained by analysis in the analysis device includes at least (1) Cross-sectional ultrasound image information on the distribution of sweat glands located within the subcutaneous tissue between 0.5 and 3.5 mm, (2) Cross-sectional echographic information on the location of sweat glands located between 0.5 and 3.5 mm below the skin surface, and (3) Information on cross-sectional ultrasound images regarding the depth of sweat glands located within the subcutaneous tissue, between 0.5 and 3.5 mm Contains, The ultrasonic probe is characterized by being a linear probe type having 128 or more elements and a driving frequency of 20 MHz or more.

[0015] According to the sweat gland testing devices of the first to third aspects of the present invention, a cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal generated by scanning the ultrasonic probe on the epidermis surface of a living body, thereby obtaining a cross-sectional echo image that clearly displays the condition of the living body below the epidermis. In addition, since the cross-sectional echo image clearly displays the condition of the living body below the epidermis, the analyzer can accurately recognize the condition of the living body below the epidermis and accurately identify the area requiring treatment.

[0016] The higher the driving frequency of an ultrasonic probe, the higher the resolution, making it possible to obtain images closer to the skin surface. Furthermore, when a linear probe is used, ultrasonic waves do not diffuse, making it possible to obtain cross-sectional echo images of a narrow range with good image quality. A more preferable driving frequency of the ultrasonic probe is 30 MHz or higher. In particular, an ultrasonic probe with a driving frequency of 30 MHz or higher can obtain cross-sectional echo images of clear image quality, making it possible to clearly recognize the location, depth, and distribution of sweat glands, or the location, spread, depth, and infiltration of malignant skin tumors, even in video. To improve resolution, a linear probe-type ultrasonic probe preferably has 128 or more elements, more preferably 192 or more elements, and even more preferably 256 or more elements. Specifically, for example, a linear probe with approximately 200 elements or, for example, 400 to 600 or more elements can be used. The greater the number of elements (the higher the element density), the better the resolution.

[0017] In the sweat gland testing device of this aspect, the condition of the living body below the epidermis includes not only information regarding the distribution of sweat glands, information regarding the position of sweat glands, and information regarding the depth of sweat glands, but also at least one of information regarding the position of malignant skin tumors, information regarding the spread of malignant skin tumors, the depth of invasion of malignant skin tumors, or information regarding the infiltration degree of malignant skin tumors.

[0018] The sweat gland testing device of this aspect can obtain not only information on the distribution of sweat glands such as apocrine glands and eccrine glands, information on the position of sweat glands, and information on the depth of sweat glands, but also information on the position, spread, and depth of malignant skin tumors, including skin cancer and malignant melanoma, etc. This makes it easier to treat axillary odor, hyperhidrosis, or malignant skin tumors.

[0019] In this type of sweat gland testing device, the analysis device determines the measurement range by scanning along the long side of the ultrasonic probe, and can grasp the condition of the living body below the epidermis by scanning along the short side of the ultrasonic probe within the determined measurement range.

[0020] According to this sweat gland testing device, the ultrasonic probe has a substantially rectangular contact surface having long and short sides and is capable of scanning in both the long and short side directions, and the cross-sectional echo image generating device displays a cross-sectional echo image based on scanning signals generated by scanning the ultrasonic probe in the longitudinal direction and the short side direction on the epidermis surface of the living body, so that a cross-sectional echo image that clearly displays the condition below the epidermis of the living body can be obtained. Also, in this sweat gland testing device, the analyzer determines a measurement range by scanning in the long side direction of the ultrasonic probe, and can grasp the condition below the epidermis of the living body by scanning in the short side direction of the ultrasonic probe within the determined measurement range.

[0021] Furthermore, according to this type of sweat gland testing device, the ultrasonic probe has a substantially rectangular contact surface with long and short sides, so that scanning along the long side of the ultrasonic probe makes it possible to clearly determine the condition of the living body below the epidermis and grasp the area requiring treatment, and furthermore, by scanning along the short side, good cross-sectional echo images can be obtained over a wide area, making it possible to diagnose the distribution and condition of sweat glands and malignant tumors in the skin.

[0022] In addition, in the sweat gland inspection device of this aspect, it is preferable that the cross-sectional echo image generating device selects and displays at least one of cross-sectional echo images before and after an anesthetic liquid is injected under the epidermis surface of a living body and images before and after treatment.

[0023] According to this type of sweat gland testing device, it is possible to display an ultrasonic echo image before the injection of anesthesia liquid, an ultrasonic echo image after the injection of anesthesia liquid, an ultrasonic echo image before treatment, and an ultrasonic echo image after treatment, either individually or by selecting and displaying any two or more ultrasonic echo images as appropriate, thereby enabling the effectiveness of treatment to be accurately determined.

[0024] In the ultrasound diagnostic imaging apparatus of this aspect, for example, the analysis device may include AI (artificial intelligence) means.

[0025] AI is a field where technological advances are rapid, and by training it with many ultrasound echo images, it will be possible to accurately and automatically obtain information about the condition of a living body below the epidermis. For example, by using AI, it will be possible to diagnose the distribution and condition of sweat glands and skin, as well as the distribution, location, and extent of malignant skin tumors.

[0026] In addition, it is preferable that the sweat gland testing device of this aspect further comprises an analysis device that analyzes the cross-sectional echo image generated by the cross-sectional echo image generating device and recognizes the subcutaneous condition.

[0027] According to the sweat gland testing device of this aspect, the analysis device that recognizes the subcutaneous condition analyzes the cross-sectional echo image generated by the cross-sectional echo image generating device, and the sweat glands can be recognized more accurately, and information regarding the distribution state of the sweat glands and the positions and depths of the sweat glands can be obtained.

[0028] A sweat gland testing device according to a fourth aspect of the present invention is the sweat gland testing device according to the first aspect, further comprising: (d) generating at least one 3D cross-sectional echo image before treatment from a scanning signal obtained by rotating the ultrasonic probe around the longitudinal axis direction of the contact surface of the epidermis of at least one living body before treatment and performing a rotational scan; (e) The analysis device is further characterized in that information on the distribution range of sweat glands can be obtained by analyzing the distribution of the sweat glands by image recognition using the 3D cross-sectional echo image.

[0029] A sweat gland testing device according to a fifth aspect of the present invention is the sweat gland testing device according to the second aspect, further comprising: (d2) generating at least one 3D cross-sectional echo image after the injection of the anesthetic agent from a scanning signal obtained by performing a rotational scan by rotating the ultrasonic probe around the longitudinal axis direction of the contact surface of the epidermis of at least one living body after the injection of the anesthetic agent; (e2) The analysis device is further characterized in that information on the distribution range of sweat glands can be obtained by analyzing the distribution of the sweat glands by image recognition using the 3D cross-sectional echo image.

[0030] A sweat gland testing device according to a sixth aspect of the present invention is the sweat gland testing device according to the third aspect, further comprising: (d3) generating a post-treatment 3D cross-sectional echo image from a scanning signal obtained by rotating the ultrasonic probe around the longitudinal axis direction of the contact surface of the epidermis of at least one living body after treatment and performing a rotational scan; (e3) The analysis device is further characterized in that information on the distribution range of sweat glands after treatment can be obtained using the post-treatment 3D cross-sectional echo image.

[0031] According to the sweat gland testing device of this type, the condition of the epidermis and below of the living body can be accurately determined, which reduces unnecessary data, such as 3D ultrasonic echo images at locations where sweat glands do not exist, and reduces the processing burden on the cross-sectional echo image generating device and the analysis device. According to the sweat gland testing device of this type, the condition of the epidermis and below of the living body can be accurately determined, which reduces unnecessary data, such as 3D ultrasonic echo images at locations where sweat glands do not exist, and reduces the processing burden on the cross-sectional echo image generating device and the analysis device.

[0032] A seventh aspect of the sweat gland inspection device of the present invention is the sweat gland inspection device of any one of the first to sixth aspects, characterized in that the ultrasonic probe is a linear probe type having 400 to 600 elements and a driving frequency of at least one of 20 MHz or more and less than 40 MHz. Since most sweat glands are located in a shallow area of ​​0.5 to 3.5 mm below the skin surface, a cross-sectional echo image near the skin surface can be obtained with high sensitivity by setting the driving frequency to 20 MHz or higher, for example, 20 MHz or higher and lower than 40 MHz. Furthermore, increasing the number of ultrasonic elements increases the resolution, making it possible to obtain high-definition cross-sectional echo images. [Effects of the Invention]

[0033] As described above, the sweat gland testing device of the present invention uses an ultrasonic probe to visualize and display the eccrine glands and apocrine glands that are sweat glands present under the skin of the human body, as well as malignant skin tumors, and can obtain information regarding the location, distribution, and depth of detected sweat glands, or the location, spread, and depth of malignant skin tumors. [Brief explanation of the drawings]

[0034] [Figure 1] 1 is a schematic diagram of an ultrasound diagnostic imaging apparatus according to the present invention. [Figure 2] FIG. 2 is an explanatory diagram of the dimensions of an ultrasonic probe and the major axis direction and the minor axis direction. [Figure 3] FIG. 3A is a side view of an antiperspirant device used in an embodiment of the present invention, and FIG. 3B is a partial cross-sectional view taken along line IIIA-IIIA of FIG. 3A. [Figure 4] Electron microscope photographs of stained skin tissue. [Figure 5] 5A to 5G are examples of observations of the armpits of a 12-year-old female. [Figure 6] 6A to 6F are examples of observations of the armpits of a 19-year-old woman. [Figure 7] 7A to 7E are examples of observations of the armpits of a 55-year-old woman. [Figure 8] 8A to 8E are observation examples of the lateral surface of the right thigh of a 53-year-old man. [Figure 9] 9A to 9E show dorsal observations of an 18-year-old male. [Figure 10] 10A and 10B are examples of observations of the armpits of a 55-year-old woman. [Figure 11] 11A and 11B are examples of observations of the armpits of a 38-year-old woman. [Figure 12] 12A to 12D show an example of an observation of the armpit of a 13-year-old female who complained of recurrence after surgery using an antiperspirant device according to an embodiment. [Figure 13] Figures 13A and 13B show preoperative observations of a 14-year-old female with palmar hyperhidrosis. [Figure 14] 14A to 14F show examples of observations using a 33 MHz driven probe on the armpit of a 14-year-old female. [Figure 15] 15A-15D are preoperative video capture images of a 14-year-old female armpit using a 33 MHz driven probe. [Figure 16] 16A-16D are video capture images of a 14-year-old female's armpit after local anesthesia using a 33 MHz driven probe. DETAILED DESCRIPTION OF THE INVENTION

[0035] Hereinafter, an ultrasound imaging diagnostic device will be described as a sweat gland testing device according to an embodiment of the present invention, with reference to the drawings. Also described will be an aspect in which information on the distribution range of sweat glands obtained by the sweat gland testing device is used in a device for treating body odor or hyperhidrosis. However, the following embodiments are merely examples of ultrasound imaging diagnostic devices and devices for treating body odor or hyperhidrosis to embody the technical concept of the present invention, and are not intended to limit the present invention to these. The present invention may be equally applied to other embodiments falling within the scope of the claims.

[0036] [Ultrasound imaging diagnostic equipment] First, an overview of an ultrasound imaging diagnostic device 10 used in the present invention will be described with reference to Fig. 1. The ultrasound imaging diagnostic device 10 itself is already well known, and as shown in Fig. 1, it includes an ultrasound probe (transducer) 11, an input / output (I / O) unit 12, an echo image generating unit 13, an analyzing unit 14, and a display unit 15. Of these, the I / O 12, the echo image generating unit 13, and the analyzing unit 14 form a signal processing unit 16. A general liquid crystal display device or an organic EL display device can be used as the display unit 15.

[0037] The I / O unit 12 supplies an ultrasonic drive signal of a predetermined frequency to the ultrasonic probe 11, receives echo signals received by the ultrasonic probe 11, and supplies the signals to the echo image generation unit 13. The echo image generation unit 13 generates signals corresponding to a cross-sectional echo image based on the echo signals, and the cross-sectional echo image is displayed on the display unit 15 based on the signals corresponding to the cross-sectional echo image. The signals corresponding to the cross-sectional echo image generated by the echo image generation unit 13 are also supplied to the analysis unit 14, which recognizes sweat glands using, for example, AI, and generates signals related to the distribution, position, and depth of the sweat glands. These signals are stored and supplied to the echo image generation unit 13, and are displayed appropriately on the display unit 15. The echo image generation unit 13 corresponds to the cross-sectional echo image generation device in the present invention, and the analysis unit 14 corresponds to the analysis device in the present invention.

[0038] A commercially available ultrasonic probe 11 is used, and in this example, a so-called hockey stick-type ultra-high frequency linear probe is used. The contact surface 11a at the tip of the ultrasonic probe 11 is a linear probe with a large number of ultrasonic elements, for example, 126 or more, arranged in a row, although individual elements are not shown. Unless an ultrasonic lens is used, the linear probe causes ultrasonic waves to enter the skin perpendicularly, preventing the ultrasonic waves from diffusing, and enabling the acquisition of high-quality cross-sectional echo images of a narrow range.

[0039] Furthermore, although increasing the frequency of the ultrasound waves results in absorption near the skin, since most sweat glands are located in a shallow area of ​​0.5 to 3.5 mm below the skin surface, it is possible to obtain highly sensitive cross-sectional echo images near the skin surface. Furthermore, increasing the number of ultrasonic elements increases the resolution, making it possible to obtain high-definition cross-sectional echo images.

[0040] The dimensions of the contact surface 11a of the ultrasonic probe 11 used in the ultrasonic diagnostic imaging device 10 of the embodiment are, as shown in Fig. 2, a width of 3 to 5 mm and a length of approximately 3 cm, with 126 or more, and in some cases 256 or more, individual ultrasonic elements arranged in a row along the length. The number of ultrasonic elements can be, for example, about 200, or, for example, 400 to 600 or more. Note that the direction corresponding to the length direction of the contact surface 11a in Fig. 2 is the major axis direction, and the direction corresponding to the width direction is the minor axis direction.

[0041] The ultrasonic probe 11 has a substantially rectangular contact surface 11a having long and short sides. The ultrasonic probe can be scanned either along the long side or along the short side to accurately and efficiently determine the distribution of sweat glands. When determining the treatment area, scanning along the long side is first performed to determine the distribution of sweat glands. That is, scanning along the long side narrows the scanable width (length of the short side), but the display range along the scanning direction (length of the long side) is wide, allowing for clear identification of sweat glands. Once the distribution of sweat glands is determined, scanning along the short side provides a wide scanable width (length of the long side), allowing for efficient identification of the distribution of sweat glands over a wide area. Furthermore, the cross-sectional echo image obtained in this manner has higher resolution and quality than conventional images, allowing the analysis unit 14 to more accurately recognize sweat glands and obtain information regarding the distribution, location, and depth of sweat glands.

[0042] Furthermore, according to the ultrasound diagnostic imaging device 10 of the embodiment, the positions and depths of the sweat glands are accurately determined by the analysis unit 14, and therefore a 3D ultrasound echo image can be obtained by rotating the ultrasound probe 11 at this position around the long axis direction of the contact surface to perform rotational scanning, or by performing scanning along the short side direction of the ultrasound probe 11. Moreover, the distribution range of the sweat glands is known from the scanning direction along the long side direction and the direction along the short side direction, that is, the positions where no sweat glands exist are known in advance, so that the acquisition of unnecessary 3D data is reduced and the processing load on the cross-sectional echo image generation unit 13 and the analysis unit 14 is reduced.

[0043] In addition, when treating axillary odor or hyperhidrosis, an anesthetic is injected before treatment, so it is preferable that the images displayed on the display unit 15 be able to be appropriately selected and displayed from three types of images: before treatment (before injection of the anesthetic), after injection of the anesthetic, and after treatment. This allows the effectiveness of treatment to be recognized more accurately. The image after injection of the anesthetic tends to make it easier to determine the position of the sweat glands with the ultrasound probe 11 than the image before injection of the anesthetic.

[0044] [Anti-perspirant device] Next, an antiperspirant device 20 used in combination with the ultrasound diagnostic imaging device 10 of the embodiment will be described with reference to Figure 3. The combination of the ultrasound diagnostic imaging device 10 and the antiperspirant device 20 corresponds to the treatment device for underarm odor or hyperhidrosis 50 of the present invention. However, the antiperspirant device 20 is not limited to the one shown in Figure 3, and other well-known configurations can also be used.

[0045] This antiperspirant device 20 mainly comprises needle electrodes 21, a cooling member 22, a support 23, and a drive unit 24. Needle electrodes 21 are made of a conductive metal material such as stainless steel, and have tapered tips 21a that can be punctured. The portions of needle electrodes 21 other than tips 21a are covered with insulating film 21b made of an electrically insulating material. A plurality of needle electrodes 21 are arranged in a matrix and fixed to rectangular plate-shaped holder 25.

[0046] It is preferable to arrange, for example, about 20 to 30 (or more) electrode needles 21, and the interval between adjacent electrode needles 21 is preferably set to, for example, about 0.5 to 3 mm (more preferably 1 to 3 mm). The thickness of each electrode needle 21 is preferably, for example, about 0.1 to 0.3 mm. The arrangement shape of the multiple electrode needles 21 may be various shapes such as a matrix, a ring, or a polygon. The holder 25 is made of a plastic material or the like, and has a recess 25a formed in the center. An elastically deformable engagement protrusion 25b is provided on the inner peripheral surface of the recess 25a. The tip 21a of the electrode needle 21 is formed in a blunt needle shape that penetrates the skin and subcutaneous tissue but does not penetrate the membrane tissue between the subcutaneous tissue and the muscle layer, allowing it to safely puncture only the depth region where sweat glands may be present.

[0047] The cooling member 22 includes a Peltier element 26, a cooling plate 27, and a heat dissipation block 28. The Peltier element 26 has a known configuration in which a p-type semiconductor and an n-type semiconductor are thermally arranged in parallel. The cooling plate 27 is provided on the heat absorption side of the Peltier element 26, and the heat dissipation block 28 is provided on the heat generation side of the Peltier element 26. A plurality of Peltier elements 26 of appropriate sizes are arranged in a matrix. The cooling plate 27 and the heat dissipation block 28 have a plurality of openings 27a, 28a formed in the spaces between the plurality of Peltier elements 26, and the opposing openings 27a, 28a form a plurality of through holes 29 that penetrate the front and back surfaces of the cooling member 22. The cooling plate 27 has a planar cooling portion 27b on the front surface, which can be brought into close contact with the epidermis of the human body.

[0048] Cooling unit 27b is provided with contact detection sensor 30 on its surface avoiding opening 27a in the approximate center, for detecting a contact state between the part to be punctured, such as the epidermis of the human body, and cooling unit 27b. Contact detection sensor 30 is made of a thin (for example, approximately 0.1 mm) pressure sensor, and outputs a contact signal or a non-contact signal with the part to be punctured.

[0049] 3A , the support 23 includes a housing 31 that is rectangular in plan view and open downward, and a cylindrical portion 32 that is connected to the center of the top plate of the housing 31, and the electrode needles 21 are held inside the housing 31. The housing 31 has guide grooves 31a formed near the openings of a pair of opposing side walls. The cooling member 22 is supported by the support 23 so that the heat dissipation block 28 can slide along the guide grooves 31a. In the closed position that covers the opening of the housing 31, the tip portions 21a of the electrode needles 21 face the through-holes 29, allowing the electrode needles 21 to be inserted into the through-holes 29. The guide grooves 31a are provided with terminal portions (not shown), and electricity can be applied to the Peltier elements 26 when the cooling member 22 is in the closed position.

[0050] The drive device 24 includes a drive motor 33 such as a servo motor, an encoder 34 that detects the rotation speed of the drive motor 33, and a rod 36 that moves forward and backward in response to the rotation of the drive motor 33. A shaft 35 is connected to a rotary shaft 33a of the drive motor 33, and a threaded portion 35a is formed on the outer surface of the shaft 35. The rod 36 is formed in a hollow cylindrical shape and is slidably housed in the cylindrical portion 32 of the support body 23. A nut 36a that threadably engages with the threaded portion 35a of the shaft 35 is fixed to the inner surface of the rod 36. Meanwhile, a protrusion 36b is formed on the outer surface of the rod 36, and the protrusion 36b engages with a groove 32a formed on the inner surface of the cylindrical portion 32, thereby preventing the rod 36 from rotating. With the above-described configuration of the drive device 24, the rod 36 can be advanced downward in FIG. 3B by the rotation of the drive motor 33, and the amount of advancement of the rod 36 can be controlled based on the detection by the encoder 34.

[0051] An engagement recess 36c is formed on the outer peripheral surface of the tip side (lower end side in FIG. 3A) of rod 36, and holder 25 can be detachably fixed to rod 36 by fitting rod 36 into recess 25a of holder 25 and engaging engagement recess 36c with engagement protrusion 25b. In this way, holder 25 can be pressed by drive device 24, and by moving rod 36 back and forth, tip 21a of needle electrode 21 can be made to protrude from and retract into cooling portion 27b, as shown by the dashed line in FIG. 3A. The amount by which needle electrode 21 protrudes from the bottom surface of cooling portion 27b can be set to, for example, about 0.1 to 10 mm.

[0052] Furthermore, a terminal (not shown) for supplying power to each needle electrode 21 when holder 25 is attached is provided at the tip of rod 36, and each needle electrode 21 is electrically connected to an externally installed high-frequency oscillator (not shown). When needle electrode 21 is inserted into the human body, a high-frequency current can be applied between it and a surface electrode (not shown) separately placed on the surface of the human body, thereby heating the biological tissue near needle electrode 21. When multiple needle electrodes 21 are provided, a configuration can also be used in which a high-frequency current is applied between two adjacent needle electrodes 21.

[0053] Electricity can be supplied to electrode needles 21, cooling member 22, and driving device 24 manually by operating a switch on operating unit 40 provided on cylindrical portion 32 of support body 23. Note that perspiration antiperspirant device 20 of this embodiment can be connected to a control device 45 that can be installed externally, such as a personal computer, and a detection signal indicating the contact state (contact or non-contact) by contact detection sensor 30 can be input to control device 45, which can then control the supply of electricity to electrode needles 21, cooling member 22, and driving device 24.

[0054] The ultrasound diagnostic imaging device 10 also has an output unit (not shown) that outputs ultrasound echo images and analysis results, and information from the output unit is input to the control device 45. Since the control device 45 receives information on the diagnosis results from the ultrasound diagnostic imaging device 10, the control device 45 can use this information to appropriately determine the treatment range (the range of sweat gland distribution, depth, etc.) and control the antiperspirant device 20. Based on this information, the control device 45 can control the position of the electrode needles on the surface of the living body's epidermis of the antiperspirant device, the depth of protrusion from the cooling unit, the timing of applying current to the electrode needles, the duration of applying current to the electrode needles, the strength of current to the electrodes, etc. The information on the diagnosis results from the ultrasound diagnostic imaging device 10 can also include control parameters used by the control device 45. The control parameters can include information such as sweat gland distribution, sweat gland location, sweat gland depth range, and sweat gland density, as well as information necessary for treatment tailored to each area, such as the timing of applying current to the electrode needles, the duration of applying current to the electrode needles, and the strength of current to the electrodes, depending on the position of the electrode needles on the epidermis surface of the body and their protrusion depth from the cooling unit of the antiperspirant device. In particular, if the ultrasound imaging diagnostic device 10 is equipped with AI means, more detailed information necessary for treatment can be obtained. Furthermore, the control device 45 stores information about the patient's past treatment history, allowing it to control the antiperspirant device 20 taking this past treatment history into consideration. Furthermore, all or part of the signal processing unit 16 of the ultrasound imaging diagnostic device 10 and all or part of the control device 45 can be integrated into a single control device, such as a personal computer. AI can also be used for calculations in the control device 45. In this case, it is possible to determine the treatment area and control parameters of the antiperspirant device 20 for each treatment area using a large amount of treatment history information and information from the ultrasound imaging diagnostic device 10.

[0055] Furthermore, the protrusion amount of the electrode needles 21 can be determined by obtaining information about the distribution, position, and depth of the sweat glands obtained by the analysis unit 14 of the ultrasound diagnostic imaging device 10 (see FIG. 1 ) and displaying it on the display unit of the control device 45, and the protrusion amount of the electrode needles 21 and the application of current can be automatically controlled. The control device 45 can also be built into the operation unit 40, and this control device 45 corresponds to the control unit in the device for treating underarm odor or hyperhidrosis of the present invention. To display the information about the distribution, position, and depth of the sweat glands obtained by the analysis unit 14 of the ultrasound diagnostic imaging device 10 on the display unit of the control device 45, the ultrasound diagnostic imaging device 10 and the control device 45 can be connected via a wired connection such as a LAN, an IEEE 1394 serial bus, or a USB, or via a wireless connection such as infrared communication, Bluetooth (registered trademark), or IEEE 802.11, or the information can be input manually.

[0056] Next, a method of using antiperspirant device 20 having the above-described configuration will be described. First, holder 25 having electrode needles 21 is attached to rod 36 of drive device 24. With cooling member 22 retracted from support 23 to open the opening of housing 31, holder 25 can be fixed to rod 36 by engaging engagement protrusions 25b with engagement recesses 36c. Next, cooling portion 27b of cooling member 22 is brought into close contact with the epidermal surface of the area to be punctured, including the sweat glands. Note that, when the distribution of sweat glands is confirmed with ultrasound diagnostic imaging device 10, it is preferable to mark the surface of the skin to identify the area to be punctured by antiperspirant device 20, as this prevents heating to an area that does not contain sweat glands requiring treatment.

[0057] When cooling part 27b and the epidermis surface come into close contact, a contact signal is input from contact detection sensor 30 to control device 45. In this state, control device 45 rotates drive motor 33 of drive device 24 by operating operation unit 40. Because protrusion 36b of rod 36 is engaged with groove 34a and cannot rotate, and nut 36a is threaded onto shaft 35, rod 36 advances in accordance with the amount of rotation of drive motor 33, and each electrode needle 21 gradually protrudes from cooling part 27b.

[0058] Generally, most apocrine glands and eccrine glands are located within a range of 0.5 mm to 3.5 mm below the skin surface. Once the location of sweat glands has been determined using the ultrasound diagnostic imaging device 10 and it has been determined that the sweat glands are located within a range of, for example, 1.5 mm to 3.0 mm, the electrode needle 21 can be initially set to a protrusion depth L of 1.5 mm and energized, then extended by another 0.5 mm and energized, and then extended by another 0.5 mm and energized again. This procedure can be repeated until the protrusion of the electrode core 21 reaches 3.0 mm, and finally the needle can be removed. Alternatively, the electrode needle 21 may be driven from a deeper protrusion to a shallower protrusion.

[0059] This allows uniform heating along the depth direction of the area to be punctured, and all of the sweat glands present in this area can be destroyed efficiently and reliably. The thermal energy supplied from electrode needles 21 may be changed according to the depth interval, and may be configured so that the greater the depth interval, the greater the thermal energy supplied. Thermal energy can be supplied using various sources, such as high frequency, radio waves, and microwaves.

[0060] The surface of the epidermis is cooled around the puncture site by the close contact of cooling unit 27b, which prevents burns and provides good pain relief during puncture and thermal energy supply. Note that if a local anesthetic is injected beforehand under the skin where cooling unit 27b is to be closely contacted, not only can the pain relief effect be obtained, but also, as will be described later, the sweat glands can be clearly identified in the echo image of the sweat glands taken by ultrasound probe 11 of ultrasound diagnostic imaging device 10.

[0061] [Subcutaneous electron microscope image] First, to explain the structure of skin tissue, Figure 4 shows an electron microscope image of a skin tissue sample obtained by collecting and staining skin tissue. Below the epidermis, the subcutaneous tissue contains a dermis layer about 0.5 mm thick, with apocrine and eccrine glands present below that. These apocrine and eccrine glands are present at a depth of about 0.5 mm to 3.5 mm. Below the apocrine and eccrine glands is a fatty layer. The thickness of the epidermis varies significantly depending on the region, being thin in the ears and armpits and thick in the palms and soles.

[0062] [Observation example] In the following, in order to confirm the effect of the device 50 for treating underarm odor or hyperhidrosis of the present invention, the above-mentioned ultrasound diagnostic imaging device 10 was used to measure the following in each area of ​​10 patients: (1) Before treatment, (2) After subcutaneous injection of an anesthetic agent, and (3) After treatment using the antiperspirant device 20, In addition to obtaining ultrasonic cross-sectional echo images at these three time points, 3D ultrasonic echo images were also obtained in any of the above states (1) to (3) as appropriate. The results are shown in Figures 5 to 14.

[0063] However, the positions at which each ultrasonic cross-sectional echo image and 3D ultrasonic echo image was taken are slightly different because the pre-treatment measurement was completed using the ultrasonic probe, the ultrasonic probe was removed, and the measurement was performed again after the anesthetic was injected and the ultrasonic probe was placed at what is believed to be the same position. Therefore, from a microscopic perspective, the images do not necessarily show the same measurement location. This is also true for the cases after the injection of the anesthetic and after treatment.

[0064] The scanning range of the ultrasonic probe 11 was determined by first determining a reference point, then scanning approximately 50 mm from the reference point along the long side of the ultrasonic probe 11 in the direction from the hand to the armpit, and then scanning approximately 30 mm along the long side of the circumferential direction of the ultrasonic probe 11 to determine the distribution of sweat glands. After that, at the position where the presence of sweat glands was confirmed, cross-sectional echo images of the sweat glands were obtained by scanning in two perpendicular directions along the short side of the ultrasonic probe 11.

[0065] Furthermore, treatment using antiperspirant device 20 was performed by first passing electricity through electrode needle 21 at the shallowest protrusion depth L based on the depth range of the sweat glands previously determined by ultrasound diagnostic imaging device 10, then extending the protrusion by another 0.5 mm and passing electricity through, and then extending the protrusion by another 0.5 mm and passing electricity through, repeating this process until electrode needle 21 protruded to the deepest depth.

[0066] In Observation Examples 1 to 7, a Canon Medical Aplio i-800 (product name) ultrasound imaging diagnostic device was used, and a high-frequency linear probe PLI-20020BT (product name) was used as the ultrasound probe. The ultrasound probe had approximately 200 ultrasound elements, and 22 MHz ultrasound was used for measurement. The distribution of sweat glands was determined by scanning along the long side of the ultrasound probe, and cross-sectional echo images of the sweat glands were obtained by scanning along the short side, thereby identifying the treatment area for the sweat glands. Three-dimensional ultrasound echo images were obtained by rotating the ultrasound probe around the long axis of the contact surface or by scanning along the short axis. The cross-sectional ultrasound echo images shown on the left side of the three-dimensional ultrasound echo images were used to confirm that blood vessels were not damaged. A Viewhot III (product name), an induction heating system using electrode needles, was used as the antiperspirant. In Observation Examples 8 to 10, an ultrasonic probe having about 400 to 600 ultrasonic elements and utilizing ultrasonic waves of 33 MHz was used for measurement.

[0067] In the drawings of the following observation examples, the areas marked with circles, ellipses, squares, etc. indicate the ranges in which sweat glands are present. In this embodiment, the analysis unit 14 of the ultrasound diagnostic imaging device 10 analyzes the distribution of these sweat glands, and the distribution, position, depth range, and density of the sweat glands are determined.

[0068] [Observation example 1] Figure 5 shows an example of an observation of the armpit of a 12-year-old female. Figure 5A is an ultrasound cross-sectional echo image before treatment, Figure 5B is after subcutaneous injection of anesthetic, Figure 5C is after treatment, and Figure 5D is after treatment at a different location. Figure 5E is a 3D ultrasound echo image before treatment, Figure 5F is after subcutaneous injection of anesthetic, and Figure 5G is after treatment.

[0069] According to the ultrasound cross-sectional echo images shown in Figures 5A to 5D, the apocrine sweat glands and eccrine glands (hereinafter simply referred to as "sweat glands") were clearly visible both before treatment (Figure 5A) and after anesthetic injection (Figure 5B), but after treatment (Figures 5C and 5D), it was confirmed that the sweat glands had essentially disappeared. This can also be confirmed from the 3D ultrasound echo images of Figures 5E to 5G. Furthermore, according to the ultrasound echo images shown on the left side of each of Figures 5E to 5G, there are no areas of blood leakage, particularly in Figure 5G, confirming that no damage was done to blood vessels during treatment.

[0070] [Observation example 2] Figure 6 shows an example of an observation of the armpit of a 19-year-old woman. Figure 6A is an ultrasound cross-sectional echo image before treatment, Figure 6B is after anesthetic was injected subcutaneously, and Figure 6C is after treatment. Figure 6D is a 3D ultrasound echo image before treatment, Figure 6E is a pre-treatment image seen from a different direction than Figure 6D, and Figure 6F is a post-treatment image.

[0071] According to the cross-sectional ultrasound echo images shown in Figures 6A to 6C, sweat glands were clearly visible both before treatment (Figure 6A) and after anesthetic injection (Figure 6B), but after treatment (Figure 6C), the sweat glands were confirmed to have essentially disappeared. This can also be confirmed from the 3D ultrasound echo images shown in Figures 6D to 6F.

[0072] [Observation example 3] Figure 7 shows an example of an observation of the armpit of a 55-year-old woman. Figure 7A is an ultrasound cross-sectional echo image before treatment, Figure 7B is after subcutaneous injection of anesthetic, and Figure 7C is after treatment. Figure 7D is a 3D ultrasound echo image before treatment, and Figure 7E is a 3D ultrasound echo image after treatment.

[0073] According to the cross-sectional ultrasound echo images shown in Figures 7A to 7C, sweat glands were clearly visible before treatment (Figure 7A), but after anesthetic injection (Figure 7B), the sweat glands were visible, although their outlines were not clear. After treatment (Figure 7C), it was confirmed that the sweat glands had essentially disappeared. This can also be confirmed from the 3D ultrasound echo images of Figures 7D and 7E. Furthermore, according to the ultrasound echo images shown on the left side of Figures 7D and 7E, there are no areas of blood leakage, particularly in Figure 7E, confirming that no damage was done to blood vessels during treatment.

[0074] [Observation example 4] Figure 8 shows an example of an observation of the lateral aspect of the right thigh of a 53-year-old male. Figure 8A is an ultrasound cross-sectional echo image before treatment, Figure 8B is after subcutaneous injection of anesthetic, and Figure 8C is after treatment. Figure 8D is a 3D ultrasound echo image before treatment, and Figure 8E is a 3D ultrasound echo image after treatment.

[0075] According to the cross-sectional ultrasound echo images shown in Figures 8A to 8C, the sweat glands were clearly visible before treatment (Figure 8A), but after anesthetic injection (Figure 8B), the sweat glands were visible, although their outlines were not clear. After treatment (Figure 8C), the sweat glands were confirmed to have essentially disappeared. This can also be confirmed from the 3D ultrasound echo images in Figures 8D and 8E.

[0076] [Observation example 5] Figure 9 shows an example of a dorsal observation of an 18-year-old male. Figure 9A is an ultrasound cross-sectional echo image before treatment, Figure 9B is an ultrasound cross-sectional echo image after subcutaneous injection of an anesthetic, and Figure 9C is an ultrasound cross-sectional echo image after treatment. Figure 9D is a 3D ultrasound echo image before treatment, and Figure 9E is an ultrasound cross-sectional echo image after treatment.

[0077] According to the cross-sectional ultrasound echo images shown in Figures 9A to 9C, the sweat glands were clearly visible before treatment (Figure 9A), but after anesthetic injection (Figure 9B), the sweat glands were visible, although their outlines were not clear. After treatment (Figure 9C), the sweat glands were confirmed to have essentially disappeared. This can also be confirmed from the 3D ultrasound echo images in Figures 9D and 9E.

[0078] [Observation example 6] Figure 10 shows an example of an observation of the armpit of a 55-year-old woman, with Figure 10A being a 3D ultrasound echo image before treatment and Figure 10B being a 3D ultrasound echo image after treatment.

[0079] 10A and 10B, the sweat glands were clearly visible before treatment (FIG. 10A), but after treatment (FIG. 10B), the sweat glands were confirmed to have essentially disappeared. This can also be confirmed from the 3D ultrasound images of FIGS. 9D and 9E. Furthermore, the ultrasound images shown on the left side of each of FIGS. 10A and 10B, particularly in FIG. 10B, show no areas of blood leakage, confirming that no blood vessels were damaged during treatment.

[0080] [Observation example 7] FIG. 11 shows an example of an observation of the armpit of a 38-year-old woman, with FIG. 11A being a 3D ultrasound echo image before treatment and FIG. 11B being a 3D ultrasound echo image after treatment.

[0081] The 3D ultrasound echo images shown in Figures 11A and 11B show that the sweat glands were clearly visible before treatment (Figure 11A), but that they had essentially disappeared after treatment (Figure 11B).

[0082] [Observation example 8] FIG. 12 shows an example of an observation of the armpit of a 13-year-old female who complained of recurrence after surgery using an antiperspirant device according to an embodiment. FIGS. 12A and 12B are an ultrasound cross-sectional echo image and a 3D ultrasound cross-sectional echo image, respectively, of the non-recurrence area, and FIGS. 12C and 12D are an ultrasound cross-sectional echo image and a 3D ultrasound cross-sectional echo image of the recurrence area.

[0083] No recurrence was observed in the ultrasound cross-sectional echo image shown in Figure 12A and the 3D ultrasound cross-sectional echo image shown in Figure 12B. However, sweat gland images were observed in the area indicated by the box in the ultrasound cross-sectional echo image shown in Figure 12C and the 3D ultrasound cross-sectional echo image shown in Figure 12D, indicating recurrence.

[0084] [Observation example 9] Figure 13 shows an example of preoperative observation of the eccrine glands of a 14-year-old female with palmar hyperhidrosis. Figure 13A is an ultrasound cross-sectional echo image, and Figure 13B is a 3D ultrasound cross-sectional echo image.

[0085] 13A and 13B, it was confirmed that the use of the ultrasonic probe of the embodiment made it possible to clearly observe sweat glands in areas with a thick epidermal layer, such as the palm of the hand.

[0086] [Observation example 10] Figure 14 shows an example of an observation of the apocrine glands in the armpit of a 14-year-old female using a 33 MHz-driven probe. Figure 14A is an ultrasound cross-sectional echo image before treatment, and Figures 14B and 14C are after local anesthesia. Figure 14D is a 3D ultrasound cross-sectional echo image before treatment, Figure 14E is an ultrasound cross-sectional echo image after treatment, and Figure 14F is a 3D ultrasound cross-sectional echo image after treatment.

[0087] 14A to 14F, when the ultrasonic probe used in the embodiment is driven at a high frequency of 33 MHz, it is clear that clearer images can be obtained both before and after treatment, as compared with FIGS. 5A to 5G, which show the case where the probe is driven at 22 MHz. In particular, comparing FIGS. 14A to 14D with FIGS. 14E and 14F allows for a good understanding of the apocrine gland images and their disappearance.

[0088] Note that a preoperative ultrasound cross-sectional echo image of the armpit of the 14-year-old female using a 33 MHz driven probe is shown in Figure 15, and a post-operative ultrasound cross-sectional echo image is shown in Figure 16. Figures 15 and 16 show images obtained when the ultrasound probe was scanned from a position where no apocrine glands were present, and the video also makes it possible to clearly identify the apocrine glands that are the treatment site for armpit odor.

[0089] The ultrasound diagnostic imaging device of the above embodiment can display not only a cross-sectional image of a single cross section in a still image, but also ultrasound cross-sectional echo images including 3D images and moving images. The ultrasound diagnostic imaging device of the above embodiment incorporates AI means, such as a neural network or convolutional neural network, that excels in image recognition. By training the AI ​​means using ultrasound echo images as training data, it becomes possible to quickly and accurately obtain information on the distribution, location, and depth of sweat glands, as well as information on the location, spread, depth, and infiltration of malignant skin tumors, from the subject's ultrasound echo images. In this case, not only a cross-sectional image of a single cross section in a still image, but also ultrasound cross-sectional echo images including 3D images and moving images can be used. In particular, the use of moving ultrasound cross-sectional echo images enables more accurate analysis of sweat glands and malignant skin tumors.

[0090] In the observation examples using the ultrasound diagnostic imaging device of the above embodiment, ultrasonic cross-sectional images of eccrine and apocrine glands were displayed. However, applying this ultrasound diagnostic imaging device to skin cancer, for example, can provide effective diagnostic results for skin cancer. That is, with the ultrasound diagnostic imaging device of the above embodiment, cross-sectional echo images that clearly display the subcutaneous condition can be obtained using the cross-sectional echo image generating device, thereby clearly displaying the location, extent, and depth of skin cancer, thereby contributing to improved therapeutic results for skin cancer. For example, using the 33 MHz ultrasound probe described in Observation Examples 8 to 10, it is possible to diagnose skin cancer, particularly with excellent accuracy, within 1 cm of the skin surface. Similarly, it is possible to diagnose malignant skin tumors, including skin cancer and malignant melanoma. [Explanation of symbols]

[0091] 10... Ultrasound imaging diagnostic device 11... Ultrasound probe (probe) 11a... Contact surface 12... Input / output (I / O) section 13... Echo image generation section 14... Analysis section 15...Display unit 20...An antiperspirant device 21...Electrode needle 21a...tip portion 21b...insulating film 22...cooling member 23...Support body 24...Driver 25...Holder 25a...recess 25b...engagement protrusion 26...peltier element 27...Cooling plate 27a...Opening 27b...Cooling section 28...heat dissipation block 28a...opening 29...through hole 30...contact detection sensor 31...casing part 31a...guide groove 32...Cylindrical portion 32a...Groove portion 33...Drive motor 33a...rotating shaft 34...encoder 35...shaft 35a...Threaded portion 36...Rod 36a...Nut 36b...protrusion 36c...engagement recess 40...operation portion 45...Control device 50...Treatment device for underarm odor or hyperhidrosis

Claims

1. an ultrasound probe; a cross-sectional echo image generating device that generates a cross-sectional echo image based on a scanning signal from the ultrasonic probe; an analyzer for analyzing the cross-sectional echo image from the cross-sectional echo image generating device to recognize the subcutaneous condition; A sweat gland testing device having the ultrasonic probe has a substantially rectangular contact surface having long sides and short sides, and is capable of scanning at least along the long side direction and along the short side direction; the cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal including scanning along at least a long side direction and a short side direction by the ultrasonic probe on the epidermis surface of the living body before treatment, after injection of an anesthetic agent, and after treatment; The cross-sectional echo image generating device (a) generating a pre-treatment longitudinal cross-sectional echo image for determining the distribution of subcutaneous sweat glands before treatment, the pre-treatment longitudinal cross-sectional echo image having a display range along the longitudinal direction wider than the length of the short side direction, from scanning signals along the longitudinal direction including scanning signals obtained by scanning along the longitudinal direction of the ultrasound probe from the reference point in a direction from the hand to the armpit; (b) generating a pre-treatment short-side cross-sectional echo image from a scan signal obtained by scanning the epidermis surface of the living body along the short side direction with the ultrasonic probe before treatment, the pre-treatment image representing the distribution of sweat glands under the skin across the long side length range; (c) the analysis device uses the pre-treatment long-side cross-sectional echo image and the pre-treatment short-side cross-sectional echo image generated by the cross-sectional echo image generating device, The pre-treatment long-side cross-sectional echo image is used to determine the distribution of subcutaneous sweat glands before treatment, which has a display range along the long side direction that is wider than the short-side length, and the pre-treatment short-side cross-sectional echo image is used to grasp the distribution of subcutaneous sweat glands over the long-side length range before treatment, By analyzing the distribution of the sweat glands by image recognition, information on the distribution range of the sweat glands is obtained, The information on the distribution range of the sweat glands obtained by the analysis in the analysis device includes at least (1) Information on cross-sectional echo images relating to the distribution of sweat glands present in the area of ​​0.5 to 3.5 mm below the skin surface; (2) Cross-sectional echo image information regarding the location of sweat glands located within a range of 0.5 to 3.5 mm below the skin surface; and (3) Information on cross-sectional echo images regarding the depth of sweat glands located within the range of 0.5 to 3.5 mm under the skin Contains, The sweat gland testing device is characterized in that the ultrasonic probe is a linear probe type having 128 or more elements and a driving frequency of 20 MHz or more.

2. an ultrasound probe; a cross-sectional echo image generating device that generates a cross-sectional echo image based on a scanning signal from the ultrasonic probe; an analyzer for analyzing the cross-sectional echo image from the cross-sectional echo image generating device to recognize the subcutaneous condition; A sweat gland testing device having the ultrasonic probe has a substantially rectangular contact surface having long sides and short sides, and is capable of scanning at least along the long side direction and along the short side direction; the cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal including scanning along at least a long side direction and a short side direction by the ultrasonic probe on the epidermis surface of the living body before treatment, after injection of an anesthetic agent, and after treatment; The cross-sectional echo image generating device (a2) generating a post-injection long-side cross-sectional echo image for determining the distribution of sweat glands after subcutaneous injection, the post-injection long-side cross-sectional echo image having a display range in the long-side direction wider than the short-side length, from scanning signals along the long-side direction including scanning signals along the long-side direction of the ultrasound probe on the epidermis surface of a living body after injection of an anesthetic, the scanning signals being obtained by scanning along the long-side direction of the ultrasound probe from the reference point in a direction from the hand to the armpit; (b2) generating a post-injection cross-sectional echo image in the short side direction from a scanning signal obtained by scanning the surface of the epidermis of the living body along the short side direction of the ultrasonic probe after injecting an anesthetic agent, the cross-sectional image capturing the distribution of sweat glands over the long side length range after subcutaneous injection; (c2) In the analysis device, using the post-injection long-side cross-sectional echo image and the post-injection short-side cross-sectional echo image generated by the cross-sectional echo image generating device, The post-injection long-side cross-sectional echo image is used to determine the distribution of subcutaneous sweat glands after injection, which has a display range along the long side direction that is wider than the short-side length, and the post-injection short-side cross-sectional echo image is used to determine the distribution of sweat glands over the long-side length range after subcutaneous injection; By analyzing the distribution of the sweat glands by image recognition, information on the distribution range of the sweat glands is obtained, The information on the distribution range of the sweat glands obtained by the analysis in the analysis device includes at least (1) Information on cross-sectional echo images relating to the distribution of sweat glands present in the area of ​​0.5 to 3.5 mm below the skin surface; (2) Cross-sectional echo image information regarding the location of sweat glands located within a range of 0.5 to 3.5 mm below the skin surface; and (3) Information on cross-sectional echo images regarding the depth of sweat glands located within the range of 0.5 to 3.5 mm under the skin Contains, The sweat gland testing device is characterized in that the ultrasonic probe is a linear probe type having 128 or more elements and a driving frequency of 20 MHz or more.

3. an ultrasound probe; a cross-sectional echo image generating device that generates a cross-sectional echo image based on a scanning signal from the ultrasonic probe; an analyzer for analyzing the cross-sectional echo image from the cross-sectional echo image generating device to recognize the subcutaneous condition; A sweat gland testing device having the ultrasonic probe has a substantially rectangular contact surface having long sides and short sides, and is capable of scanning at least along the long side direction and along the short side direction; the cross-sectional echo image generating device displays a cross-sectional echo image based on a scanning signal including scanning along at least a long side direction and a short side direction by the ultrasonic probe on the epidermis surface of the living body before treatment, after injection of an anesthetic agent, and after treatment; The cross-sectional echo image generating device (a3) generating a post-treatment short-side cross-sectional echo image from a scanning signal obtained by scanning the epidermis surface of the living body along the short side direction with the ultrasonic probe after treatment, the post-treatment image representing the distribution of sweat glands under the skin over the long side length range; (b3) In the analysis device, using the post-treatment long-side cross-sectional echo image and the post-treatment short-side cross-sectional echo image generated by the cross-sectional echo image generating device, (c3) determining a distribution state of subcutaneous sweat glands after treatment having a display range wider than the length in the short side direction in a direction along the long side direction from the post-treatment long side cross-sectional echo image, and grasping a distribution of subcutaneous sweat glands over the range of the long side direction length from the post-treatment short side cross-sectional echo image; By analyzing the distribution of sweat glands after treatment using image recognition, information on the distribution range of sweat glands after treatment can be obtained. By this, the distribution of sweat glands over the range of the long side direction after subcutaneous injection is grasped, By analyzing the distribution of the sweat glands by image recognition, information on the distribution range of the sweat glands is obtained, The information on the distribution range of the sweat glands obtained by the analysis in the analysis device includes at least (1) Information on cross-sectional echo images relating to the distribution of sweat glands present in the area of ​​0.5 to 3.5 mm below the skin surface; (2) Cross-sectional echo image information regarding the location of sweat glands located within a range of 0.5 to 3.5 mm below the skin surface; and (3) Information on cross-sectional echo images regarding the depth of sweat glands located within the range of 0.5 to 3.5 mm under the skin Contains, The sweat gland testing device is characterized in that the ultrasonic probe is a linear probe type having 128 or more elements and a driving frequency of 20 MHz or more.

4. (d) generating at least one 3D cross-sectional echo image before treatment from a scanning signal obtained by rotating the ultrasonic probe around the longitudinal axis direction at the contact surface of the epidermis surface of at least one living body before treatment and performing a rotational scan; (e) The sweat gland inspection device according to claim 1, characterized in that the analysis device further uses the 3D cross-sectional echo image to analyze the distribution of the sweat glands through image recognition, thereby obtaining information on the distribution range of the sweat glands.

5. (d2) generating at least one 3D cross-sectional echo image after injecting an anesthetic agent from a scanning signal obtained by rotating the ultrasonic probe around the longitudinal axis direction at the contact surface of the epidermis surface of at least one living body after injecting an anesthetic agent and performing a rotational scan; (e2) The sweat gland inspection device according to claim 2, characterized in that the analysis device further uses the 3D cross-sectional echo image to analyze the distribution of the sweat glands through image recognition, thereby obtaining information on the distribution range of the sweat glands.

6. (d3) generating a post-treatment 3D cross-sectional echo image from a scanning signal obtained by rotating the ultrasonic probe around the longitudinal axis direction at the contact surface of the epidermis surface of at least one living body after treatment to perform a rotational scan; (e3) The sweat gland testing device according to claim 3, characterized in that the analysis device further obtains information on the distribution range of sweat glands after treatment using the post-treatment 3D cross-sectional echo image.

7. 7. The sweat gland testing device according to claim 1, wherein the ultrasonic probe is a linear probe type having 400 to 600 elements and a driving frequency of at least one of 20 MHz or more and less than 40 MHz.

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