Ultrasonic diagnostic image processing probe device, ultrasonic diagnostic apparatus and urine quantity measuring device
By adopting cross-irradiation ultrasonic beam and electronic scanning technology in ultrasonic diagnostic systems, the problems of complex operation and prone to equipment failure in the prior art are solved, and the effects of simplifying operation, reducing errors and improving application convenience are achieved.
Patent Information
- Application Number
- JP2023178766
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-10-17
- Publication Date
- 2025-04-30
AI Technical Summary
The existing ultrasound diagnostic system is complex when measuring urine volume. Especially for beginners, it is difficult to accurately capture the bladder center and measure urine volume. The equipment is complex and prone to failure, and the cost is high, making it difficult to widely use in a home medical environment.
An ultrasonic diagnostic image processing probe is adopted. The probe is placed parallel to the body surface on the front side. Through the crossing of the first and second acoustic beams, cross-sectional and longitudinal ultrasonic image data are generated. Through electronic scanning technology, the angle of the acoustic beam is adjusted to avoid reflection of the coupling body to ensure the accuracy of the image.
Simplifies the operation process, reduces the operator's personal error, reduces the complexity and failure rate of the equipment, and improves the convenience and accuracy of application in a home medical environment.
Smart Images

Figure 2025068769000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an ultrasonic diagnostic apparatus and the like used in the medical field and the like. [Background technology]
[0002] Conventionally, in the medical field and the like, ultrasonic diagnostic devices have been widely used to non-invasively observe and diagnose the condition of a subject including various tissues in the human body (e.g., organs, bones, muscles, fat, tumors, etc. (hereinafter referred to as "tissues, etc."). This type of ultrasonic diagnostic device generally includes an ultrasonic probe and a main unit. The ultrasonic probe transmits sound waves (also referred to as "ultrasound") in a predetermined frequency band to the subject and receives the sound waves (i.e., echoes) reflected by the subject. The main unit is configured to generate ultrasonic diagnostic image data consisting of a plurality of ultrasonic diagnostic image frames (e.g., B-mode images, etc.) capturing an image of the subject based on a reception signal generated based on the echoes received by the ultrasonic probe, and to display an ultrasonic diagnostic image based on the generated data.
[0003] Recently, an ultrasound diagnostic system has been put into practical use that enables ultrasound image diagnosis at low cost without being limited in location by consolidating the function of generating ultrasound diagnostic image data in a portable ultrasound probe device, transmitting the ultrasound diagnostic image data generated by the ultrasound probe device alone to a general image display device (hereinafter referred to as a "display device") such as a smartphone, a tablet-type information and communication terminal device, a PC (personal computer) or a PC monitor, and displaying the image on the display device (for example, Non-Patent Document 1). Such an ultrasound probe device with a built-in ultrasound diagnostic image data generating function (hereinafter referred to as an "ultrasound diagnostic image processing probe device" to distinguish it from a general ultrasound probe) generates ultrasound diagnostic image data by itself based on the reception result of the echo received from the subject, and transmits the generated ultrasound diagnostic image data to the display device by wire or wirelessly. Meanwhile, the display device is configured to display an ultrasound diagnostic image based on the ultrasound diagnostic image data received from the ultrasound diagnostic image processing probe device. This type of ultrasound diagnostic system makes it possible to easily obtain and confirm an ultrasound diagnostic image of a subject even in the field of home medical care, etc.
[0004] Here, in medical settings, including at home, it is important to measure and manage the amount of urine in the subject's bladder in order to understand and manage the pathological condition of the patient (subject). When trying to measure the amount of urine in the subject's bladder using the above-mentioned conventional ultrasound diagnostic system, it is necessary to capture ultrasound diagnostic images of the transverse and longitudinal sections of the bladder using the ultrasound diagnostic system, measure the inner diameters of the bladder in the left-right, up-down, and front-back directions (i.e., depth direction), and calculate the volume inside the bladder (or bladder volume, the same applies below) based on the measurement results, which makes the measurement work complicated. In addition, in order to depict the transverse and longitudinal section images of the bladder using the conventional ultrasound diagnostic system, it is necessary to change the direction in which the ultrasound diagnostic image processing probe device is abutted against the subject's body by 90° and change the scanning direction of the sound beam by 90°. Furthermore, since the bladder is located behind the pubic bone, if an ultrasound probe is placed directly above the bladder (i.e., on the front side (ventral side) of the subject's body) in a supine position and scanning is performed with a sound beam, the sound beam is reflected by the pubic bone, making it impossible to accurately depict the bladder behind the pubic bone. For this reason, in order to accurately depict each image of the transverse and longitudinal sections of the bladder, a technique is required to operate the ultrasound probe so that the sound beam reaches the bladder behind the pubic bone while preventing the reflection of the ultrasound by the pubic bone. In general, when observing the bladder and measuring the urine volume, a technique is required in which the ultrasound probe is placed in a position slightly above (head side of) the pubic bone in a supine position, the ultrasound probe is tilted toward the pubic bone while the device is pressed into the lower abdomen, the transmission angle of the sound beam transmitted (irradiated) from the ultrasound probe with respect to the body surface is changed, and the sound beam is irradiated to an appropriate position on the bladder, making it difficult for beginners to grasp the exact location of the bladder. In particular, in conventional ultrasound diagnostic systems, the ultrasound diagnostic image processing probe device or ultrasound probe is separate from the display device or main unit, so that the user needs to hold the display device or operate the main unit with one hand while finely operating the ultrasound diagnostic image processing probe device or ultrasound probe with the other hand, which makes the procedure for accurately measuring the bladder volume even more complicated.This problem is not limited to the bladder, but also applies to other tissues (e.g., tissues around the bladder such as the prostate and large intestine) present behind the pubic bone around the bladder, and in order to observe them and measure size parameters such as the width, height, depth, area, and volume of the tissues, complicated procedures must be performed. Under these circumstances, a portable urine volume measuring device that automatically measures the amount of urine in the bladder has been proposed in recent years and has been partially put into practical use (e.g., Patent Document 1 and Non-Patent Document 2). In this urine volume measuring device, a motor is used to rotate a sector-type ultrasonic probe in a case pressed against the body surface, and while depicting bladder images in multiple directions, a volume scan is performed to automatically calculate and display the internal volume of the subject's bladder (i.e., urine volume). Recently, ultrasonic probes have been proposed that have two linear probes arranged in a T-shape to enable imaging of transverse and longitudinal sections at approximately the same time (e.g., Patent Document 2), and ultrasonic diagnostic devices have been proposed that have an ultrasonic probe that has transducer arrays arranged in a cross shape or that can oscillate one transducer array using a motor to enable imaging of cross-sectional images in two or more directions at approximately the same time (e.g., Patent Document 3). [Prior art documents] [Patent documents]
[0005] [Patent Document 1] Patent No. 7043622 [Patent Document 2] Patent No. 6379363 [Patent Document 3] Patent No. 5672241 [Non-patent literature]
[0006] [Non-Patent Document 1] Nikkei Online Edition, "Terumo to Provide Wireless Ultrasound Diagnostic Device for Infusions and Other Uses," December 8, 2020,<URL:https: / / www.nikkei.com / article / DGXZQODZ079PC0X01C20A2000000 / > [Non-Patent Document 2] Sysmex Corporation, "Bladder Ultrasound Imaging Diagnostic Device BladderScan System BVI 6100 [Retrieved June 12, 2023],"<URL:https: / / products.sysmex.co.jp / products / ultrasound / bvi6100 / index.html> Summary of the Invention [Problem to be solved by the invention]
[0007] However, when the urine volume measuring device described in Patent Document 1 and Non-Patent Document 2 is used to accurately depict the bladder and measure the urine volume with high accuracy, a procedure is required to accurately capture the center of the bladder with a sound beam, and in reality, it is difficult for a beginner who is not familiar with the procedure to irradiate the sound beam to the center of the bladder, and personal errors due to the operator's experience are large. In addition, since the sector-type probe in the case is configured to be driven by a motor, the device becomes complicated and is prone to malfunction. On the other hand, by adopting the configuration described in Patent Documents 2 and 3, it is possible to simultaneously image the transverse and longitudinal sections of the subject, but in order to irradiate the sound beam accurately perpendicular to the tissue around the bladder behind the pubic bone, a procedure is required to adjust the position and angle of the sound beam while pushing the ultrasound probe into the subject's lower abdomen, as in the case of a conventional ultrasound diagnostic system, and this makes it difficult for beginners to operate. Furthermore, if a configuration in which the transducer array is oscillated is adopted, the device becomes complex and heavy, so it can only be used in certain locations and is expensive, making it difficult to use in situations such as home medical care where the amount of urine in a patient's bladder (i.e., bladder volume) can be easily measured.
[0008] The present invention has been made in consideration of the above-described circumstances, and its object is to provide an ultrasonic diagnostic image processing probe device, an ultrasonic diagnostic device, and a urine volume measuring device which enable easy and detailed observation of tissues, etc., where sound wave reflectors exist between the subject's body surface and the specimen, such as the tissues around the subject's bladder, and which enable measurement of size parameters of the tissues, etc., such as length, area, volume, etc., easily, quickly, conveniently, and while reducing the occurrence of personal errors due to the experience of the operator. [Means for solving the problem]
[0009] (1) In order to achieve the above object, an ultrasonic diagnostic image processing probe device of the present invention is an ultrasonic diagnostic image processing probe device that is used in a state of being in parallel or approximately parallel contact with a body surface on the front side of a body part of a subject, and generates ultrasonic diagnostic image data by imaging a subject inside the subject, the ultrasonic diagnostic image processing probe device comprising: a first ultrasonic transmitting / receiving means provided in the ultrasonic diagnostic image processing probe device and consisting of a first transducer array arranged along a first direction parallel to a reference plane that is located opposite to the body surface of the subject during imaging, and configured to output, as a first output signal, an electrical signal obtained by applying a first ultrasonic beam to the subject; and a second ultrasonic transmitting / receiving means arranged along a second direction perpendicular to the first direction and arranged in an approximately T-shape with the first transducer array, and configured to output, as a second output signal, an electrical signal obtained by applying a second ultrasonic beam to the subject within a predetermined transmission angle range that is perpendicular to the first ultrasonic beam; (A1) transmitting the first ultrasonic beam from the first ultrasonic transmitting / receiving means, and (A2) transmitting the second ultrasonic beam from the first ultrasonic transmitting / receiving means. a driving means for transmitting the second sound beam from a transmitting / receiving means; and (1) maintaining the first direction parallel or approximately parallel to a cross section of the subject's body part, (2) aligning the second direction along the midline of the subject's body part, and (3) bringing the reference plane into contact with a predetermined position on the subject's suprapubic bone while aligning it with the body surface on the front side of the subject's body part, (B1) electronically scanning the subject in the first direction with the first sound beam to generate first ultrasonic diagnostic image data of the subject in the first direction. and (B2) a generating means for electronically scanning the subject in the second direction with the second sound beam to generate second ultrasound diagnostic image data of the subject in the second direction, and storing the data in a memory means so that the data can be used. In the abutting state, the first transducer array is installed at a predetermined first angle inclined toward the tail of the subject's body as viewed from the normal direction of the reference plane, and is configured to transmit the first sound beam that is inclined at the first angle toward the tail as viewed from the normal direction and intersects with the second sound beam.
[0010] With this configuration, the ultrasonic diagnostic image processing probe device of the present invention, when capturing an ultrasonic diagnostic image, has the operator (contact condition 1) maintain a first direction (corresponding to a first scanning direction SD1 described later) parallel or approximately parallel to a transverse section of the subject's body surface front side (ventral side) of the subject's body part, (contact condition 2) align the second direction (corresponding to a second scanning direction SD2 described later) along the median line of the subject's body part, and (contact condition 3) place the reference plane against the body surface on the front side of the subject's body part, and When the quasi-plane is brought into contact with the subject's body surface in an undeformed state so as to be parallel or approximately parallel to the virtual tangent or tangent plane (corresponding to "VT" in Figs. 7B and 7C described later), a first sound beam that is inclined at a first angle toward the tail of the subject's body as viewed from the normal direction of the reference plane (hereinafter also simply referred to as the "normal direction"), is perpendicular to the second sound beam, and intersects with the second sound beam can be transmitted (irradiated) from the first transducer array (see Figs. 1, 3, 4, 7, and 8). Note that when the phrase "the reference plane is brought into contact with the body surface on the front side of the subject's body part while facing it" is used in the "claims", this refers to a state in which the ultrasonic diagnostic image processing probe device is brought into contact with the reference plane so as to be parallel or approximately parallel to the virtual tangent or tangent plane of the subject's body surface in an undeformed state. In addition, in this specification, the term "subject's body surface in an undeformed state" refers to the subject's abdominal body surface in an undeformed state with no pressure being applied to the abdomen when the subject is in a specified position, such as supine.
[0011] Here, the normal direction of the reference plane that is the basis of the first angle needs to be appropriately set according to the shape of the installation surface (corresponding to installation surfaces 12A and 120A described later) on which the first and second sound wave transmitting and receiving means (corresponding to first and second probes 111 and 112 described later) composed of the first and second transducer arrays are installed. For example, (case 1) when the entire installation surface has a shape composed only of planes that are maintained parallel or approximately parallel to the virtual tangent or tangent plane of the body surface in an undeformed state during imaging, the installation surface (installation surface 12A described later) itself can be used as the reference plane, and the normal direction thereof can be used as the reference. Also, (Case 2) when the installation surface has a shape that includes at least a part of a flat portion that is maintained substantially parallel to a virtual tangent or tangent plane of the body surface in an undeformed state at the time of imaging, the normal direction of the flat portion or a virtual plane including the flat portion (for example, when the installation surface has flat portions corresponding to the four corners, a virtual plane formed by connecting the flat portions of the four corners) is set, and a virtual plane that expands the flat portion or this virtual plane is set as a reference plane, and the normal direction of the virtual plane is used as a reference. Furthermore, (Case 3) when the entire installation surface is a hemispherical, wavy, uneven, inclined, or other installation surface that does not include any flat portion that is maintained substantially parallel to a virtual tangent or tangent plane of the body surface in an undeformed state at the time of imaging (corresponding to the installation surface 120A described later), a plane different from the installation surface (a virtual reference plane VRP described later) that is maintained parallel or substantially parallel to a virtual tangent or tangent plane of the body surface at the time of imaging is set as a reference plane, and the normal direction of the virtual plane is used as a reference plane, which will be described in detail later. The reference plane is not limited to the above as long as it is a plane that is maintained parallel or approximately parallel to the virtual tangent or tangent plane of the body surface in an undeformed state during imaging within the device, and another plane (for example, another plane within the device that is parallel to the installation surface in the above case 1) can be used and its normal direction can be used as the reference. In the above cases 2 and 3, it is desirable to clearly indicate the position and orientation of the virtual plane or virtual reference plane on the side of the device housing so that the operator can grasp it.
[0012] A typical conventional ultrasonic diagnostic imaging probe device is configured such that a sound beam is transmitted in a direction perpendicular to the arrangement direction (electronic scanning direction) of the transducer array constituting the device, with the transducer array in contact with the body surface. Therefore, when the transducer array is contacted with the body surface above the pubic bone, the sound beam transmitted from the transducer array is reflected by the pubic bone before reaching the tissue around the bladder of the subject, and an accurate ultrasonic diagnostic image of the subject cannot be drawn. Therefore, when observing the subject and measuring the size parameters, the ultrasonic diagnostic imaging probe device is contacted slightly above (toward the head of) the pubic bone so that the arrangement direction of the transducer array is parallel to the transverse section, and while tilting the probe toward the pubic bone, a procedure is required in which (1) the angle at which the ultrasonic diagnostic imaging probe device is contacted with the subject's body surface, (2) the contact position of the ultrasonic diagnostic imaging probe device, and (3) the amount of pressure are finely adjusted so that the sound beam is appropriately irradiated on the transverse section of the subject. As a result, it becomes difficult for an operator who is unfamiliar with the operation of an ultrasonic diagnostic apparatus to accurately image the bladder and measure the urine volume.
[0013] On the other hand, according to the present configuration, when the ultrasonic diagnostic image processing probe device is placed symmetrically on the midline of the subject's body so that the first transducer array is located at a predetermined position (specifically, about 5 to 6 cm headward) above the pubic bone (head side) of the subject (see Fig. 7(A) and Fig. 22), the first sound beam is irradiated toward the dorsal side while being inclined at a first angle toward the caudal side of the subject's body as viewed from the normal direction. As a result, according to the present configuration, the first sound beam is irradiated obliquely from the upper front side (ventral side) of the body surface in the dorso-caudal direction to the tissue around the bladder, which is the subject, without being reflected by a reflector such as the pubic bone. Therefore, according to the present configuration, the first sound beam can be appropriately irradiated to the cross section of the tissue around the bladder located behind the reflector such as the pubic bone, simply by the operator placing the ultrasonic diagnostic image processing probe device at a predetermined position above the pubic bone so as to satisfy the above-mentioned contact conditions (1) to (3). As a result, according to the present invention, an accurate cross-sectional image of the subject can be captured without being affected by the pubic bone, which acts as a reflector. Also, according to the present invention, the cross-sectional image can be used to measure size parameters, making it possible to easily, quickly, and conveniently measure size parameters such as urine volume while reducing the occurrence of personal errors due to the operator's experience. In particular, since the center of the bladder is located about 5 to 6 cm dorsal from the body surface in a subject of standard build, when the first angle is set to "45°" and the operator abuts the ultrasonic diagnostic image processing probe device at a predetermined position above the pubic bone while satisfying the abutment conditions (1) to (3) above, the first sound beam inclined at "45°" toward the caudal side of the subject's body as viewed from the normal direction is irradiated in the dorsal-caudal direction, making it possible to depict the cross section of the bladder while avoiding the pubic bone (see FIG. 7(B)). Although the distance from the body surface to the center of the bladder varies depending on the body type of the subject (see Figure 7(C)), the cross section of the bladder can be appropriately imaged for subjects of any body type by simply adjusting the angle of the ultrasonic diagnostic image processing probe device toward the head by about "15° to 40°." This will be described in detail later.
[0014] In addition, in the ultrasonic diagnostic image processing probe device of the present invention, in a contact state that satisfies the contact conditions (1) to (3) above, the second transducer array performs electronic scanning in a scanning direction (i.e., a second direction that is a second scanning direction SD2 described later) that is perpendicular to the first direction, which is the scanning direction of the first transducer array, and transmits a second acoustic beam that is perpendicular to the first acoustic beam and has a predetermined transmission angle range (for example, an angular range of about "5 to 30°" on the cranial side of the subject's body and about "65 to 80°" on the caudal side, a total of about "70 to 110°", when viewed from the normal direction in the contact state above) from the ventral side to the dorsal side of the subject's body along the midline of the subject's body. When capturing an overall image of the longitudinal section of the bladder using a general conventional ultrasonic diagnostic imaging probe device, the transducer array of the ultrasonic diagnostic imaging probe device is placed slightly above (toward the head of) the pubic bone so that the direction of the array is along the median plane of the subject (a sagittal plane along the midline, also called the "midsagittal plane"; the same applies below), and the probe is tilted toward the pubic bone, and the reflection of the sound beam by the pubic bone is prevented, so that the sound beam is appropriately irradiated onto the longitudinal section of the subject. This requires a technique of finely adjusting (1) the angle at which the ultrasonic diagnostic imaging probe device is placed on the subject's body surface, (2) the position at which the ultrasonic diagnostic imaging probe device is placed, and (3) the amount of pressure applied. As a result, it becomes difficult for an operator who is not familiar with the operation of the ultrasonic diagnostic imaging probe device to appropriately capture an overall image of the longitudinal section of the bladder and measure the urine volume. This is the same as when capturing a transverse section image. On the other hand, in the ultrasonic diagnostic image processing probe device of the present invention, the second sound beam is irradiated from the upper ventral side to the dorsal side along the midline of the subject's body while having a transmission angle range of, for example, about "70° to 110°" in the abutment state satisfying the above abutment conditions (1) to (3). Therefore, the second sound beam is irradiated while keeping the entire longitudinal section of the subject within the transmission angle range without being reflected by the pubic bone. As a result, an appropriate longitudinal section image of the subject can be captured easily, quickly, and conveniently while reducing the occurrence of personal errors due to the operator's experience.
[0015] Furthermore, in the ultrasonic diagnostic image processing probe device of the present invention, the first sound beam SB1 and the second sound beam SB2 are configured to be irradiated in a mutually orthogonal and crossed state. Therefore, each image of the transverse section and the longitudinal section of the subject can be captured at the same position of the tissue around the bladder as the subject. As a result, according to this configuration, the tissue around the bladder as the subject can be observed in detail based on the image of the subject captured at the same position, and can be used to measure size parameters such as urine volume, and size parameters can be measured easily and quickly without performing complicated procedures, and the occurrence of personal errors due to the experience of the operator can be reduced. Note that when the first transducer array and the second transducer array are arranged in a substantially cross shape, the first sound beam and the second sound beam will necessarily cross, but when both transducer arrays are arranged in a substantially T-shape as in the ultrasonic diagnostic image processing probe device of the present invention, it is necessary to satisfy a certain condition in order to cross the sound beams irradiated from both transducer arrays, which will be described in detail later. In addition, in the present invention, the images of the first and second cross sections can be images of the transverse and longitudinal sections of the tissue around the bladder that is the subject, and can also be images of the short axis and long axis sections of other tissues, etc.
[0016] As a result, the ultrasonic diagnostic image processing probe device of the present invention can accurately capture images of the transverse and longitudinal sections of the subject and can be used for observing the subject and measuring size parameters such as length, area, and volume by simply abutting the ultrasonic diagnostic image processing probe device symmetrically with respect to the midline of the subject's body so that the first transducer array is located 5 to 6 cm above the subject's pubic bone while satisfying the abutment conditions (1) to (3) and electrically switching the scanning direction. Therefore, the ultrasonic diagnostic image processing probe device of the present invention can dramatically facilitate and speed up the procedures for observing the subject and measuring the urine volume, as compared with conventional ultrasonic diagnostic devices, and can realize observation of the subject and measurement of the urine volume while reducing the occurrence of personal errors due to the operator's experience.
[0017] (2) In the above configuration, the present invention may further include an extraction means for performing a predetermined signal processing on each of the first and second ultrasonic diagnostic image data generated by the generation means and stored in the storage means, and extracting an image area in which the subject appears in each of the ultrasonic diagnostic images in the first and second directions, and a measurement means for measuring a value of at least one size parameter of the length, area, and volume of the subject based on the extracted image area, and storing the measured size parameter value in the storage means so that it can be used.
[0018] With this configuration, the ultrasonic diagnostic image processing probe apparatus of the present invention can measure and make available the values of size parameters of a subject based on a captured ultrasonic diagnostic image.
[0019] (3) In addition, in the configuration described in claim 2, the generating means may be configured to (1) electronically scan the subject in the first direction with the first sound beam to generate the first ultrasonic diagnostic image data corresponding to a cross-sectional image of the subject, and (2) electronically scan the subject in the second direction with the second sound beam to generate the second ultrasonic diagnostic image data corresponding to a longitudinal section image of the subject, the extracting means performs a predetermined signal processing on the ultrasonic diagnostic image data corresponding to each of the generated cross-sectional images and longitudinal section images, extracts an image area in which the subject appears in each of the cross-sectional images and longitudinal section images, and the measuring means measures the size of the subject in the horizontal, vertical and depth directions based on each of the extracted image areas, and calculates the volume of the subject based on the measured values. Note that in this specification, the horizontal, vertical and depth directions are defined as the left-right direction as viewed from the front side (ventral side) of the subject's body part, and the up-down direction as the vertical direction. In addition, the ventral side is defined as the front and the dorsal side as the rear, and the depth direction is defined as the front-to-back direction.
[0020] With this configuration, the ultrasonic diagnostic image processing probe apparatus of the present invention can measure the amount of urine in the subject's bladder by measuring the bladder internal volume (or bladder volume) as a size parameter while using the subject's bladder as the object.
[0021] (4) In the configuration according to any one of claims 1 to 3, the first angle may be set within a transmission angle range of the second sound beam by the second transducer array.
[0022] With this configuration, the ultrasonic diagnostic image processing probe device of the present invention can reliably cross the first and second sound beams while making them perpendicular to each other, and can capture the first and second cross-sectional images at the same position on the subject, thereby enabling observation of the subject and measurement of size parameters while reducing the occurrence of personal errors due to experience.
[0023] (5) Furthermore, in the configuration described in any one of claims 1 to 3, the second transducer array may be configured to transmit, in the abutting state, (A) a direction inclined at a predetermined second angle toward the tail of the subject's body when viewed from the normal direction, which corresponds to either the starting point or the end point of the transmission angle range, and (B) a direction inclined at a predetermined third angle toward the head of the subject's body when viewed from the normal direction, which corresponds to the other point of the transmission angle range.
[0024] With this configuration, the ultrasonic diagnostic image processing probe apparatus of the present invention, when the bladder is used as the subject, can reliably capture the entire second cross section of the subject with the second acoustic beam, thereby capturing an entire image of the subject.
[0025] (6) Furthermore, in the configuration described in claim 4, the second transducer array may be configured to transmit the second acoustic beam in the abutting state such that (A) a direction inclined at a predetermined second angle toward the tail of the subject's body when viewed from the normal direction corresponds to either one of the starting point or the end point of the transmission angle range, and (B) a direction inclined at a predetermined third angle toward the head of the subject's body when viewed from the normal direction corresponds to the other point of the transmission angle range.
[0026] With this configuration, the same effect as that of claim 5 can be achieved.
[0027] (7) In the configuration according to any one of claims 1 to 3, the first angle may be set within an angle range of 30 degrees to 60 degrees.
[0028] With this configuration, by simply adjusting the contact angle of about "15° to 40°" while the ultrasound diagnostic image processing probe device is in contact with the midline symmetrically so that the first transducer array is located 5 to 6 cm above the subject's pubic bone in a state where the contact conditions (1) to (3) above are satisfied, it is possible to easily, easily and reliably capture a cross-sectional image of the bladder while preventing reflection from the pubic bone, and perform observation and urine volume measurement for subjects of any body type (see FIG. 7). This will be described in detail later.
[0029] (8) In the configuration described in claim 4, the first angle may be set within an angle range of 30 degrees to 60 degrees.
[0030] With this configuration, the same effect as that of claim 7 can be achieved.
[0031] (9) In the configuration described in claim 5, the first angle may be set within an angle range of 30 degrees to 60 degrees.
[0032] With this configuration, the same effect as that of claim 7 can be achieved.
[0033] (10) In the configuration described in claim 6, the first angle may be set within an angle range of 30 degrees to 60 degrees.
[0034] With this configuration, the same effect as that of claim 7 can be achieved.
[0035] (11) Furthermore, in the configuration described in any one of claims 1 to 3, the second transducer array may be installed at a position that is closer to the head of the subject's body than the installation position of the first transducer array in the abutting state, and the first transducer array may be inclined at the first angle toward the tail side opposite the side where the second transducer array is installed when viewed from the normal direction, and may transmit the first sound beam that intersects with the second sound beam.
[0036] With this configuration, even when the second transducer array is disposed at a position closer to the head of the subject's body than the position where the first transducer array is disposed in the above-mentioned abutment state, and a first sound beam inclined at a first angle toward the tail of the subject's body, which is opposite the side where the second transducer array is disposed as viewed from the normal direction, is irradiated from the first transducer array (see FIG. 21), (1) the first direction is maintained parallel or approximately parallel to the transverse plane so that the first transducer array is located on the tail of the subject's body relative to the second transducer array (corresponding to the above-mentioned abutment condition (1)), and (2) the second direction is aligned with the midline. (3) while keeping the reference plane parallel or approximately parallel to the virtual or tangential plane of the body surface (corresponding to the above-mentioned abutment condition (3)), the ultrasonic diagnostic image processing probe device is abutted symmetrically with respect to the midline so that the first transducer array is located at a predetermined position (specifically, about 5 to 6 cm above) above the pubic bone (head side) of the subject (see Fig. 7(B) and Fig. 22), and the abutment angle is adjusted by about "15° to 40°", so that the transverse and longitudinal sections of the subject can be appropriately depicted and imaged regardless of the subject's body type. As a result, according to this configuration, the operation for observing the tissue around the bladder behind the pubic bone and measuring the urine volume can be dramatically simplified, and not only can the same effect as that of claim 1 be achieved, but also the degree of freedom in designing the device can be dramatically improved.
[0037] (12) Furthermore, in the configuration described in claim 4, the second transducer array may be installed at a position that is closer to the head of the subject's body than the installation position of the first transducer array in the abutting state, and the first transducer array may be inclined at the first angle toward the tail side opposite the side where the second transducer array is installed when viewed from the normal direction, and transmit the first sound beam that intersects with the second sound beam.
[0038] With this configuration, the same effect as that of claim 11 can be achieved.
[0039] (13) Furthermore, in the configuration described in claim 5, the second transducer array may be installed at a position that is closer to the head of the subject's body than the installation position of the first transducer array in the abutting state, and the first transducer array may be inclined at the first angle toward the tail side opposite the side where the second transducer array is installed when viewed from the normal direction, and may transmit the first sound beam that intersects with the second sound beam.
[0040] With this configuration, the same effect as that of claim 11 can be achieved.
[0041] (14) Furthermore, in the configuration described in claim 6, the second transducer array may be installed at a position that is closer to the head of the subject's body than the installation position of the first transducer array in the abutting state, and the first transducer array may be inclined at the first angle toward the tail side opposite the side where the second transducer array is installed when viewed from the normal direction, and may transmit the first sound beam that intersects with the second sound beam.
[0042] With this configuration, the same effect as that of claim 11 can be achieved.
[0043] (15) Furthermore, in the configuration described in claim 7, the second transducer array may be installed at a position that is closer to the head of the subject's body than the installation position of the first transducer array in the abutting state, and the first transducer array may be inclined at the first angle toward the tail side opposite the side where the second transducer array is installed when viewed from the normal direction, and may transmit the first sound beam that intersects with the second sound beam. Ultrasound diagnostic imaging probe device.
[0044] With this configuration, the same effect as that of claim 11 can be achieved.
[0045] (16) The ultrasonic diagnostic apparatus of the present invention is an ultrasonic diagnostic apparatus that is used in a state of being in contact with a body surface on the front side of a subject's body in parallel or approximately parallel thereto, and generates and displays ultrasonic diagnostic image data obtained by imaging an object inside the subject's body, the ultrasonic diagnostic apparatus is provided with a first transducer array arranged along a first direction parallel to a reference plane that is located opposite the body surface of the subject during imaging, and includes a first acoustic wave transmitting / receiving means that outputs an electrical signal obtained by applying a first acoustic beam to the object as a first output signal, and a second transducer array arranged along a second direction perpendicular to the first direction. and a second acoustic wave transmitting / receiving means configured with a second transducer array arranged in a substantially T-shape with the first transducer array, which is perpendicular to the first acoustic beam and transmits an electrical signal obtained by applying a second acoustic beam to the subject within a predetermined transmission angle range as a second output signal, wherein the first transducer array (1) maintains the first direction parallel or substantially parallel to a transverse section of the subject's body part, (2) aligns the second direction along the midline of the subject's body part, and (3) positions the reference plane relative to a body surface on the front side of the subject's body part with respect to a predetermined position on the subject's suprapubic bone. a probe unit that, in a contact state in which the probe is inclined at a predetermined first angle toward the tail of the subject's body part as viewed from a normal direction of the reference plane, transmits the first sound beam that is inclined at the first angle toward the tail as viewed from the normal direction and crosses the second sound beam; (A1) a drive unit that causes the first sound beam to be transmitted from the first sound wave transmitting / receiving means, and (A2) a drive unit that causes the second sound beam to be transmitted from the second sound wave transmitting / receiving means; and (B1) in the contact state, electronically scans the subject in the first direction with the first sound beam to scan the subject's body part in the first direction. a generating means for generating first ultrasonic diagnostic image data in a first direction, and (B2) electronically scanning the subject in the second direction with the second sound beam to generate second ultrasonic diagnostic image data of the subject in the second direction, and storing the second ultrasonic diagnostic image data in a usable manner in a storage means; a display unit mounted on the device itself or externally connected, which displays an ultrasonic diagnostic image of the subject in at least one of the first and second directions based on at least one of the generated first and second ultrasonic diagnostic image data, and controls display on the display unit based on the first and second ultrasonic diagnostic image data,and a display control means for causing the display unit to display an ultrasonic diagnostic image in at least one of the first and second directions.
[0046] With this configuration, the ultrasonic diagnostic apparatus of the present invention can capture images of the transverse and longitudinal sections of the subject as images corresponding to the first and second cross sections by making the first and second ultrasonic wave transmitting and receiving means of the probe transmit first and second ultrasonic beams while the probe unit having the same configuration as that of claim 1 is abutted symmetrically with respect to the midline of the subject's body so that the first transducer array is located at a predetermined position (specifically, a position about 5 to 6 cm headward) above the pubic bone (head side) of the subject in a state where the abutment conditions of (1) to (3) are satisfied (see Figs. 7 and 22). At least one of the captured images of the transverse and longitudinal sections can be displayed by making the first and second ultrasonic wave transmitting and receiving means of the probe transmit first and second ultrasonic beams. Note that the probe unit employed in the ultrasonic diagnostic apparatus of the present invention can have the same configuration as that of claim 1, as well as the configurations described in claims 2 to 10.
[0047] (17) In the configuration described in claim 16, the driving means may be configured to alternately transmit the first and second sound beams from the first sound wave transmitting / receiving means and the second sound wave transmitting / receiving means in the contact state, the generating means may alternately generate the first and second ultrasonic diagnostic image data in units of one frame, and the display control means may be configured to simultaneously display the ultrasonic diagnostic images in the first and second directions, which are captured approximately simultaneously, on the display unit in approximately real time while synchronizing the images based on the first and second ultrasonic diagnostic image data corresponding to each of the alternately generated frames.
[0048] With this configuration, ultrasonic diagnostic images in the first and second directions can be alternately captured one frame at a time and displayed simultaneously. For example, when the transverse and longitudinal sections are alternately captured at 10 fps (frames per second), the image capturing and display update time for each frame is about 100 msec (milliseconds). Therefore, by simultaneously displaying the ultrasonic diagnostic images captured alternately in the first and second directions with this configuration, the human can visually recognize that the ultrasonic diagnostic images captured approximately simultaneously in the first and second directions are displayed simultaneously without any sense of incongruity, and the convenience of the operator and the observation accuracy during the observation of the subject can be improved.
[0049] (18) A urine volume measuring device according to the present invention is used in a state of being in contact with a body surface on the front side of a subject's body in parallel or approximately parallel, generates ultrasonic diagnostic image data by imaging the bladder in the subject, and measures and displays the amount of urine in the subject's bladder based on the ultrasonic diagnostic image data. The urine volume measuring device includes a first ultrasonic wave transmitter / receiver that is provided with a first transducer array arranged along a first direction parallel to a reference plane that is located opposite to the body surface of the subject during imaging, and outputs an electrical signal obtained by applying a first ultrasonic beam to the subject as a first output signal. and a second transducer array arranged along a second direction perpendicular to the first direction and arranged in a substantially T-shape with the first transducer array, the second transducer array being perpendicular to the first acoustic beam and configured to apply a second acoustic beam to the subject within a predetermined transmission angle range and output an electrical signal obtained as a second output signal, wherein the first transducer array (1) maintains the first direction parallel or substantially parallel to a transverse section of the subject's body, (2) aligns the second direction along the midline of the subject's body, and (3) aligns the first transducer array with respect to a predetermined position on the subject's suprapubic bone. a probe unit that is installed in a state where the reference plane is opposed to the body surface on the front side of the subject's body part and in contact with the body surface, the probe unit is inclined at a predetermined first angle toward the tail side of the subject's body part as viewed from a normal direction of the reference plane, and transmits the first sound beam that is inclined at the first angle toward the tail side as viewed from the normal direction and crosses the second sound beam; (A1) a drive means that transmits the first sound beam from the first sound wave transmitting and receiving means, and (A2) a drive means that transmits the second sound beam from the second sound wave transmitting and receiving means; and (B1) a front sound beam that is inclined at the first angle toward the tail side as viewed from the normal direction and crosses the second sound beam in the contact state. a generating means for electronically scanning the subject in the first direction to generate cross-sectional image data corresponding to the cross-sectional image of the bladder, and (B2) electronically scanning the bladder in the second direction with the second acoustic beam to generate longitudinal image data corresponding to the longitudinal image of the bladder, and storing the generated longitudinal image data in a storage means so as to be usable; an extracting means for performing a predetermined signal processing on each of the generated cross-sectional and longitudinal image data stored in the storage means, and extracting an image area in which the bladder appears in each of the cross-sectional and longitudinal images; andThe device has a measuring means for measuring the size of the inside of the bladder in each of the horizontal, vertical and depth directions, calculating the volume of the inside of the bladder based on the measured values, and storing the calculated values in a memory means so that the calculated values can be used; a display unit mounted on the device itself or connected externally, for displaying the calculated value of the inside bladder volume together with the cross-sectional and longitudinal section images; and a display control means for controlling the display of the cross-sectional and longitudinal section images and the display of the inside bladder volume on the display unit, and for simultaneously displaying the calculated value of the inside bladder volume as a measurement value of the urine volume together with the cross-sectional and longitudinal section images used in measuring the inside bladder volume on the display unit.
[0050] With this configuration, the urine volume measuring device of the present invention, in a state where the probe unit having the same configuration as that of claim 3 satisfies the above-mentioned abutment conditions (1) to (3), is abutted symmetrically with respect to the midline of the subject's body so that the first transducer array is located at a predetermined position above the pubic bone (head side) of the subject (specifically, a position about 5 to 6 cm above), (see Figs. 7 and 22), and transmits first and second sound beams from the first and second sound wave transmitting and receiving means of the probe unit, captures images of the subject's transverse and longitudinal sections as ultrasonic diagnostic images corresponding to the first and second directions, measures the left-right, up-down, and front-to-back inner diameters of the bladder from the captured transverse and longitudinal images, calculates the bladder volume (urine volume), and simultaneously displays the images of the transverse and longitudinal sections used to calculate the urine volume and the calculated value of the urine volume. Compared to conventional urine volume measuring devices, this makes it possible to realize urine volume measurement in a much easier, faster, and more convenient manner, while reducing the occurrence of personal errors due to experience. The probe section may have the same configuration as that of claim 3, or may have the configurations of claims 4 to 10. Effect of the Invention
[0051] The ultrasonic diagnostic image processing probe, ultrasonic diagnostic device, and urinary volume measuring device of the present invention enable easy and detailed observation of tissues, etc., where sound wave reflectors exist between the subject's body surface and the specimen, such as the tissues around the subject's bladder, and enable measurement of size parameters such as length, area, volume, etc. of the tissues, etc. easily, quickly, conveniently, and with reduced occurrence of personal error due to experience. [Brief description of the drawings]
[0052] [Figure 1] FIG. 1 shows an example of the external configuration of an embodiment of an ultrasound diagnostic device according to the present invention, in which (A) is a perspective view of the ultrasound diagnostic device as seen from the top side, and (B) shows the positional relationship between the first and second sound beams transmitted from the ultrasound diagnostic device and the subject (bladder) when imaging the subject using the ultrasound diagnostic device. [Diagram 2] 1A and 1B are diagrams showing an example of the external configuration of an ultrasound diagnostic device according to one embodiment, as viewed from the bottom side, in which (A) is an oblique view of the ultrasound diagnostic device as viewed from the bottom side, and (B) is an oblique view of the ultrasound diagnostic device as viewed from the bottom side with the body surface-contacting case provided on the bottom side of the ultrasound diagnostic device removed (i.e., a perspective view of the probe portion with the body surface-contacting case removed). [Diagram 3] 2A and 2B are side views of an ultrasonic diagnostic apparatus according to one embodiment, in which (A) is a side view seen from the direction "A" in FIG. 2B, and (B) is a side view seen from the direction "B". [Figure 4] 2A and 2B are side views of an ultrasonic diagnostic apparatus according to one embodiment, in which (A) and (B) show side views seen from the directions "C" and "D" in FIG. 2B, respectively. [Diagram 5] FIG. 1 shows an example of the configuration of a first and second probe constituting an ultrasound diagnostic apparatus according to one embodiment, in which (A) shows a cross-sectional view of both probes, and (B) shows an example of the arrangement of transducer arrays constituting both probes. [Figure 6] FIG. 4 is a diagram showing the relationship between the installation angles and installation positions of the first and second probes and the irradiation directions of the first and second sound beams, on the side surface on the same side as the side view shown in FIG. 3(B). [Figure 7]1A and 1B show an example of the positional relationship between the subject and the contact position and direction of the ultrasound diagnostic device when observing the subject and measuring the urine volume with the ultrasound diagnostic device of one embodiment, in which (A) shows the relationship between the contact position and direction of the ultrasound diagnostic device when observing, etc., (B) shows the anatomical positional relationship between the subject, the ultrasound diagnostic device, the first probe, and the transmission direction of the first sound beam when the ultrasound diagnostic device is contacted with a subject of normal build in the position and orientation shown in (A), and (C) shows the anatomical positional relationship between the subject, the ultrasound diagnostic device, the first probe, and the transmission direction of the first sound beam when the ultrasound diagnostic device is contacted with an obese subject in the position and orientation shown in (A). [Figure 8] 7A and 7B are diagrams showing the relationship between the anatomical directions of the human body, the installation directions of the first and second probes, and the irradiation direction of the sound beams transmitted from each probe when the probe portion is placed against the subject as shown in FIG. 7A for observing the subject or measuring urine volume using an ultrasound diagnostic apparatus according to one embodiment, where (A) shows the anatomical directions of the human body, (B) shows the relationship between the installation direction of the first probe and the irradiation direction of the first sound beam, and (C) shows the relationship between the installation direction of the second probe and the irradiation direction of the second sound beam. [Figure 9] 1A to 1C are diagrams for explaining the principle of measuring the left-right and up-down diameters of a subject from a transverse cross-sectional image frame in an ultrasound diagnostic apparatus according to one embodiment. [Figure 10] 1A to 1C are diagrams for explaining the principle of measuring the anterior-posterior diameter and the superior-inferior diameter of a subject from a longitudinal sectional image frame in an ultrasound diagnostic apparatus according to one embodiment. [Figure 11] 1 is a block diagram showing an example of a functional configuration of an ultrasound diagnostic apparatus according to an embodiment; [Figure 12] 4 is a flowchart showing a process executed by a control unit in an observation mode in the ultrasound diagnostic apparatus of one embodiment. [Figure 13] 4 is a flowchart showing a urine volume measurement process executed by a control unit in the ultrasound diagnostic apparatus of one embodiment. [Figure 14] 1 is a diagram showing an example of an image displayed on a display unit during urine volume measurement in the ultrasound diagnostic apparatus of one embodiment. FIG. [Figure 15] 4 is a flowchart showing an image region extraction process executed by a control unit in the ultrasound diagnostic apparatus of one embodiment. [Figure 16] 7 is a diagram showing the relationship between the installation angles and installation positions of the first and second probes and the irradiation directions of the first and second sound beams in the first modified example according to the present invention, viewed from the same direction as FIG. 6. [Figure 17] 7 is a diagram showing the relationship between the installation angles and installation positions of the first and second probes and the irradiation directions of the first and second sound beams in a second modified example according to the present invention, viewed from the same direction as FIG. 6. FIG. [Figure 18] 11A and 11B show an example of the configuration of an ultrasonic diagnostic device in a fourth modified example according to the present invention, in which (A) is an external configuration diagram of the device as seen from above, and (B) shows the configuration of a probe section provided inside the housing of the ultrasonic diagnostic device, assuming that the configuration is the same as that of the embodiment. [Figure 19] 18A is a cross-sectional view showing an example of the external configuration of an ultrasonic diagnostic apparatus in a fourth modification according to the present invention, as viewed from the "D direction" in FIG. 18(A). [Figure 20] FIG. 13 is a cross-sectional view showing a configuration example of a body surface contact case in a fifth modified example according to the present invention. [Figure 21] FIG. 11 is a diagram showing the relationship between the installation angles and installation positions of the first and second probes and the irradiation directions of the first and second sound beams, in a side view of the probe unit constituting an ultrasonic diagnostic apparatus according to a sixth modified example of the present invention, seen from the same direction as in FIG. [Figure 22] FIG. 13 is a diagram showing an example of a method of contacting the ultrasonic diagnostic device of Modification 6 when observing the tissue around the bladder and measuring the urine volume using the ultrasonic diagnostic device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0053] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. The following embodiment is an embodiment in which an ultrasonic diagnostic image processing probe device, an ultrasonic diagnostic device, and a urine volume measuring device according to the present invention are applied to an ultrasonic diagnostic device that transmits sound waves (ultrasound waves) of a predetermined frequency to the tissue around the bladder of a subject who is a subject, receives echoes of the sound waves in the subject, generates ultrasonic diagnostic image data consisting of a plurality of ultrasonic diagnostic image frames in which the subject is imaged based on the echoes, measures the value of at least one size parameter of the length, area, and volume of the subject based on the ultrasonic diagnostic image data, and simultaneously displays the measurement result and the ultrasonic diagnostic image used for the measurement. However, the embodiment described below does not unduly limit the contents of the present invention described in the claims, and all of the configurations described in the present embodiment are not necessarily essential components of the present invention. In addition, the specific tissue around the bladder in the subject's body that is a subject is arbitrary, and tissue around the bladder such as the prostate gland or large intestine can also be a subject. However, in this embodiment, for the sake of concrete explanation, the subject is the subject's bladder, and the urine volume in the subject's bladder (i.e., bladder internal volume or bladder volume) is measured as a size parameter, and the measurement result of the urine volume is simultaneously displayed together with an ultrasound diagnostic image of the bladder used for the measurement. Furthermore, in the present invention, the function of displaying the ultrasound diagnostic image and the measurement result of the urine volume may be realized by an externally connected display, but in this embodiment, the description will be given assuming that these are displayed using a display (display unit 17 described later) built into the ultrasound diagnostic device. Note that the built-in or externally connected display function as this display constitutes the "ultrasonic diagnostic device" and "urine volume measuring device" of the present invention, and the one without the display function constitutes the "ultrasonic diagnostic image processing probe device" of the present invention.
[0054] [A] Embodiment [A1] Overall configuration and overview of ultrasound diagnostic device 1 First, the configuration and overview of an ultrasonic diagnostic device 1 according to an embodiment of the present invention will be described with reference to Fig. 1. Fig. 1 is a diagram showing an example of the external configuration of the ultrasonic diagnostic device 1 of this embodiment, in which (A) is a perspective view of the ultrasonic diagnostic device 1 as seen from the top side of the device, and (B) shows the positional relationship between the first and second sound beams SB1 and SB2 transmitted (irradiated) from the ultrasonic diagnostic device 1 and the subject S when imaging the subject S (bladder) using the ultrasonic diagnostic device 1.
[0055] As shown in Fig. 1, the ultrasonic diagnostic device 1 of this embodiment is provided with a probe section 11 having first and second probes 111 and 112 constituted by a transducer array 111C (see Fig. 5) described later and a body surface contact case 11A for covering these probes 111 and 112 on the bottom side of a housing 12 of the device having a rectangular parallelepiped shape. The ultrasonic diagnostic device 1 is configured to (1) transmit a first sound beam SB1 having a predetermined frequency band (for example, any frequency band from 1 MHz to 10 MHz) from the first probe 111 constituting the probe section 11 in order to capture a transverse cross-sectional image as a first cross-sectional image of the subject S, and (2) transmit a second sound beam SB2 from the second probe 112 to the subject S, which is perpendicular to the first sound beam SB1 and intersects with the first sound beam SB1, in order to capture a longitudinal cross-sectional image as a second cross-sectional image of the subject S. The ultrasonic diagnostic device 1 (1) receives the echo of the first sound beam SB1 from the subject S by the first probe 111, captures a cross-sectional image of the subject S based on the echo, and generates corresponding ultrasonic diagnostic image data (hereinafter also referred to as "cross-sectional image data"). The ultrasonic diagnostic device 1 (2) receives the echo of the second sound beam SB2 from the subject S by the second probe 112, captures a longitudinal image of the subject S based on the received echo, and generates corresponding ultrasonic diagnostic image data (hereinafter also referred to as "longitudinal image data"). The ultrasonic diagnostic device 1 is configured to operate in an observation mode in which, when (A) the power is turned on and a predetermined input operation is performed on an operation unit 15 (see FIG. 11 ) described later, the ultrasonic diagnostic device 1 synchronizes and simultaneously displays each of the cross-sectional and longitudinal images of the subject S in approximately real time based on the cross-sectional image data and longitudinal image data generated using both the probes 111 and 112. In this embodiment, the operator can observe each of the cross-sectional and longitudinal images displayed simultaneously in this observation mode and diagnose the condition of the subject S. With this configuration, the ultrasonic diagnostic apparatus 1 of this embodiment realizes the function of a normal ultrasonic diagnostic apparatus for observing a subject S, etc.
[0056] In addition, when the operator performs an input operation to instruct the operation unit 15 to measure the amount of urine (hereinafter referred to as a "urine amount measurement instruction") in a state in which a cross-sectional image and a longitudinal section image are simultaneously displayed in the observation mode, the ultrasound diagnostic device 1 of this embodiment transitions to a urine amount measurement mode and executes a urine amount measurement process (see FIG. 13). Then, the ultrasound diagnostic device 1 measures (calculates) the volume inside the bladder through this process, and simultaneously displays the measurement result of the bladder volume and each of the cross-sectional and longitudinal section images used for the measurement. At this time, the ultrasound diagnostic device 1 measures the left-right, up-down, and front-back inner diameters of the bladder based on each of the cross-sectional and longitudinal section images captured using both probes 111 and 112, and calculates the amount of urine in the bladder based on the measurement result. The observation mode and the urine amount measurement mode will be described in detail later. 1, in this embodiment, a display unit 17 is provided on the upper surface of the housing 12 of the ultrasound diagnostic device 1 for (1) simultaneously displaying images of a transverse section and a longitudinal section based on ultrasound diagnostic image data, and (2) simultaneously displaying the measurement result of the urine volume and the images of the transverse section and the longitudinal section used for the urine volume measurement. In this embodiment, whether observing the subject S or measuring the urine volume, the operator brings the probe unit 11 provided on the bottom surface of the housing 12 into contact with the body surface of the subject on the front side (ventral side) of the subject's body while the subject is in a supine position, and adjusts the contact direction, contact angle, pushing amount, etc. of the ultrasound diagnostic device 1 while observing the ultrasound diagnostic image displayed on the display unit 17 provided on the upper surface, thereby enabling detailed observation of the condition of the subject S and adjustment of the contact angle, pushing amount, etc. to capture an image optimal for the urine volume measurement. (1) The specific configuration of the probe unit 11, (2) the position, direction and angle at which the ultrasound diagnostic device 1 is brought into contact with the body surface of the subject S when observing the subject S and measuring the urine volume, and (3) the principle of measuring the urine volume in the ultrasound diagnostic device 1 will be described in detail later. Furthermore, the specific configuration of both probes 111 and 112 is arbitrary, and both may be of a convex type, both may be of a linear type, both may be of a micro-convex type, or both may be of a sector type. Furthermore, both probes 111 and 112 may be configured as different types of probes, and in this case, the combination is arbitrary.However, in this embodiment, a convex type probe is used as the first probe 111, and a micro-convex type probe is used as the second probe 112, and the probe unit 11 is described as being combined with these. This configuration suppresses size restrictions when constructing the probe unit 11, and makes it possible to accurately capture the entire transverse and longitudinal sections of the bladder without depending on the amount of urine in the bladder, and to easily, quickly, and accurately depict and image each cross section while preventing the occurrence of personal errors due to experience. In this case, the frequency band of the sound beams transmitted and received by both probes 111 and 112 is arbitrary. For example, the first sound beam SB1 transmitted and received by the first probe 111 may be in a frequency band of about 1 to 10 MHz, and the second sound beam SB2 may be in a frequency band of about 1 to 10 MHz.
[0057] Here, when measuring urine volume using an ultrasonic diagnostic image processing probe device (for example, Non-Patent Document 1) equipped with a conventional general transducer array (also called one-dimensional transducer array) in which transducers are arranged in one direction as described above, the transducer array is placed in contact with a position slightly above (head side of) the pubic bone of the subject, parallel to the cross section of the subject's body, and the bladder is electronically scanned along the cross section while tilting the probe toward the pubic bone to capture a cross section image (see FIG. 9), and then the ultrasonic probe device is rotated 90° to place the transducer array in contact with the midline of the subject's body, and the bladder is electronically scanned along the midline while tilting the probe toward the pubic bone to capture a longitudinal section image (see FIG. 10), and it is necessary to measure the left-right, up-down, and front-back inner diameters of the bladder based on the captured cross section and longitudinal section images to calculate the bladder volume, which makes the measurement work complicated. On the other hand, although the adoption of the methods described in Patent Document 1 and Non-Patent Document 2 can reduce the workload when measuring urine volume, it cannot be eliminated that the device becomes more complicated and more prone to malfunctions, and it takes some getting used to to measure.
[0058] In addition, when adopting a configuration in which two transducer arrays are arranged in a cross or T shape as described in Patent Documents 2 and 3, an ultrasound probe having a cross or T-shaped transducer array is placed in contact with an appropriate position on the surface of the subject's body (for example, a position slightly above the pubic bone (head side)), and while tilting the probe toward the pubic bone, the scanning direction of one transducer array constituting the ultrasound probe is set parallel or approximately parallel to the cross section of the subject's body and the scanning direction of the other transducer array is set along the midline of the subject's body, and the scanning direction is electrically changed by 90° to obtain the desired image of the subject. Images of both the transverse and longitudinal sections of the body S can be captured at the same time. Therefore, with this configuration, it is possible to reduce the workload when observing the subject S and measuring the urine volume. However, since the bladder is located behind the pubic bone, if a configuration in which two probes (corresponding to the first and second probes 111 and 112 in this embodiment) are simply arranged in a cross or T shape as in these conventional ultrasonic diagnostic devices, the sound beams (corresponding to the first and second sound beams SB1 and SB2 in this embodiment) transmitted from these probes are not transmitted before they reach the subject S. It is impossible to exclude the possibility that the ultrasonic wave reflected by the pubic bone may cause the transverse and longitudinal sections of the subject S to be rendered inaccurately. For this reason, when attempting to render the transverse and longitudinal sections of the subject S in an accurate manner using this method, a procedure is required in which the angle at which the probe abuts the subject's body surface, the abutment position, and the amount of pressure are finely adjusted while pushing the ultrasonic probe into the lower abdomen of the subject in a supine position during observation and urine volume measurement of the subject S, making it difficult for beginners who are unfamiliar with the operation to accurately capture and observe the transverse and longitudinal images of the subject S or measure the urine volume. In particular, in these conventional devices, the ultrasonic probe and the display device or main unit are configured separately. For this reason, the operator is required to operate the main unit or display device with one hand while operating the ultrasonic probe with the other hand. As a result, the difficulty of the operation during observation and urine volume measurement increases, making it difficult to properly observe the bladder or accurately measure the urine volume. This point is also true for the observation of tissues around the bladder other than the bladder and the measurement of their size parameters.
[0059] Therefore, in the ultrasonic diagnostic apparatus 1 of this embodiment, a method is adopted in which the configuration of the probe unit 11 is devised to reduce the operational burden on the operator when observing the tissue around the bladder and measuring the urine volume, and the configuration will be described next.
[0060] [A2] Schematic configuration of probe section 11 Next, the schematic configuration of the probe unit 11 adopted in the ultrasonic diagnostic device 1 of this embodiment to solve the above problem will be described with reference to Figs. 2 to 5. Fig. 2 is a diagram showing an example of the external configuration of the ultrasonic diagnostic device 1 of this embodiment seen from the bottom side, in which (A) is a perspective view of the ultrasonic diagnostic device 1 seen from the bottom side of the device, and (B) is a perspective view of the ultrasonic diagnostic device 1 seen from the bottom side in a state in which the body surface-contact case 11A provided on the bottom side of the ultrasonic diagnostic device 1 is removed (i.e., a perspective view of the probe unit 11 with the body surface-contact case 11A removed). Figs. 3 and 4 are side views of the ultrasonic diagnostic device 1, in which Fig. 3(A) shows a side view seen from the direction of "A" in Fig. 2(B), and (B) shows a side view seen from the direction of "B" in the same figure. Figs. 4(A) and (B) show side views seen from the directions of "C" and "D" in Fig. 2(B), respectively. Furthermore, Figure 5 is a diagram showing an example of the configuration of the first and second probes 111 and 112 of this embodiment, where (A) shows a cross-sectional view of both probes 111 and 112, and (B) shows an example of the configuration of the transducer array 111C that constitutes both probes 111 and 112.
[0061] As shown in FIG. 2(B), a first probe 111 and a second probe 112 constituting the probe unit 11 are installed on the bottom side (i.e., the surface on which the probe unit 11 is installed and which faces the body surface of the subject S when observing the subject S and measuring the amount of urine (hereinafter, also referred to as the "installation surface 12A") of the housing 12 of the ultrasonic diagnostic device 1 of this embodiment. The first probe 111 has: (1) a transducer array 111C (see FIG. 5) in which a plurality of transducers 111C-n, each of which is made up of an element such as a piezoelectric element, are arranged along a first scanning direction SD1, and the transducer array 111C is arranged so as to scan the subject S from the side thereof. To capture a cross-sectional image, electronic scanning is performed in a first scanning direction SD1 to transmit a first sound beam SB1 while receiving an echo of the first sound beam SB1 from the subject S. On the other hand, the second probe 112 has a transducer array 111C (see FIGS. 5 and 7(A)) that is arranged along a second scanning direction SD2 perpendicular to the first scanning direction SD1 and is arranged to form a substantially T-shape with the transducer array 111C of the first probe 111, with the center of the transducer array 111C of the first probe 111 as the starting point or ending point; In order to capture a longitudinal sectional image of the subject S, electronic scanning is performed in the second scanning direction SD2 to transmit a second sound beam SB2 that is perpendicular to and intersects with the first sound beam SB1, while receiving an echo of the second sound beam SB2 in the subject S. The probe section 11 is provided with a body surface contact case 11A that covers both probes 111 and 112, and the first and second probes 111 and 112 and the body surface contact case 11A constitute the probe section 11. As shown in FIG. 5(A), the first and second probes 111 and 112 are A material that does not easily attenuate sound waves, such as gel or oil, is filled between the acoustic lens 111E (see FIG. 5(A)) of each of the first probe 111 and the body surface contact case 11A of each of the second probe 112, forming a gel or oil layer 11B described later. Furthermore, in this embodiment, the first scanning direction SD1 is set to coincide with a reference line segment RLS connecting the center points of both ends of the transducer array 111C constituting the first probe 111 (see FIG. 5), and the second scanning direction SD2 coincides with a line segment (not shown) connecting the center points of both ends of the transducer array 111C of the second probe 112.The first and second scanning directions SD1 and SD2 in this embodiment correspond to the "first and second directions" of the invention, respectively.
[0062] In the present invention, the specific shapes of the housing 12 and the installation surface 12A are arbitrary, and for example, a spherical or ellipsoid housing 12 can be used, and various shapes can be adopted for the installation surface 12A. However, in this embodiment, in order to facilitate understanding of the invention, a case is described in which a rectangular parallelepiped housing 12 is used and the installation surface 12A is a flat surface with no inclination, and cases in which other shapes are adopted will be described in detail in the section on modified examples.
[0063] In this embodiment, the first probe 111 is installed so that the reference line segment RLS and the first scanning direction SD1 are parallel to the installation surface 12A (see (A) of Figs. 3 and 4), and when the body surface contact case 11A is brought into contact with the subject's body surface during imaging of an ultrasonic diagnostic image of the subject S, the installation surface 12A becomes a plane facing the subject's body surface, and the installation surface 12A itself constitutes a reference plane. Therefore, in this embodiment, when the probe section 11 is brought into contact so that the installation surface 12A is parallel or approximately parallel to a virtual tangent or tangent plane (Fig. 7 "VT" to be described later) of the subject's body surface in an undeformed state, (1) the installation surface 12A becomes parallel or approximately parallel when viewed from the virtual tangent or tangent plane VT, and (2) the virtual tangent or tangent plane VT becomes parallel or approximately parallel when viewed from the installation surface 12A. Therefore, in this embodiment, the operator can satisfy the above-mentioned abutment condition (3) by abutting the probe unit 11 so that the virtual tangent or tangent plane VT of the undeformed subject's body surface is parallel or approximately parallel to the installation surface 12A, and the normal direction of the installation surface 12A corresponds to the "normal direction" of the present invention. Note that the specific method for the operator to abut the probe unit 11 so that the virtual tangent or tangent plane VT of the undeformed subject's body surface is parallel or approximately parallel to the installation surface 12A is arbitrary, and as exemplified in Fig. 2, the body surface contact case 11A may be configured to have a planar structure that is parallel to the installation surface 12A on the surface that abuts against the subject's body surface when capturing an ultrasonic diagnostic image, or a line parallel to the installation surface 12A may be printed or engraved on the side of the housing 12, and the operator may visually adjust the abutment angle so that the line and the virtual tangent or tangent plane VT of the undeformed body surface are parallel or approximately parallel.
[0064] Next, of the probes 111 and 112, the first probe 111 is configured as a convex probe with a curvature of about 60 (mm) and a field angle of about 60°. Meanwhile, the second probe 112 is configured as a micro-convex probe with a curvature of about 14 (mm) and a field angle of about 70° to 110°. The field angle of the second probe 112 can be freely set within this angle range, which will be described in detail later. As shown in Figures 5(A) and (B), both probes 111 and 112 are configured by stacking (1) a transducer base 111A for fixing the transducer array 111C, (2) a backing material 111B fixed to the transducer base 111A and for preventing the backward propagation of the corresponding sound beams SB1 and SB2, (3) a transducer array 111C configured by arranging a plurality of transducers 111C-1 to n (hereinafter referred to as "transducers 111C-n") on the backing material 111B at a pitch of approximately 0.5 mm along the corresponding electronic scanning directions (i.e., the first and second scanning directions SD1 and SD2), (4) a matching layer 111D formed on the transducer array 111C for acoustic matching, and (5) an acoustic lens 111E formed on the matching layer 111D for focusing. In this embodiment, a material such as gel or oil is filled between the acoustic lens 111E and the body surface contact case 11A to form a gel or oil layer 11B between the body surface contact case 11A, and the probe section 11 is constructed as a whole. In this embodiment, the two probes 111 and 112 basically adopt the same structure except that they have different curvatures and angles of view, so that FIG. 5 shows only a configuration example of the first probe 111, but the second probe 112 also has the same configuration as FIG. 5. For this reason, in this specification, the components of the first and second probes 111 and 112 will be described using the same reference symbols. However, in this embodiment, the second probe 112 is installed at an angle with respect to the installation surface 12A as shown in FIG. 2 and FIG. 6 to be described later, and therefore the line segment connecting the center points of both ends of the transducer array 111C of the second probe 112 is not the reference line segment RLS shown in FIG. 5, etc.In addition, both probes 111 and 112 may be configured with a cMUT (Capacitive Micromachined Ultrasonic Transducer) type transducer array, and when this configuration is adopted, matching layer 111D and acoustic lens 111E can be omitted. For example, each transducer array 111C constituting first and second probes 111 and 112 of this embodiment respectively constitutes the "first and second transducer arrays" of the present invention.
[0065] Next, the body surface contact case 11A is made of a hard material such as a thermosetting resin or a thermoplastic resin having a predetermined curvature with respect to the installation surface 12A, such as a semi-ellipsoid or a semi-sphere, and the curvature in one direction is set to about "60 (mm)" which is the same as the curvature of the first probe 111. The specific shape of the surface of the body surface contact case 11A that comes into contact with the body surface when capturing an ultrasonic diagnostic image of the subject S (i.e., when observing the bladder of the subject S and measuring the urine volume) is arbitrary, and may have a partially flat structure as in the example shown in Figs. 1 and 2, or may have a curved shape entirely. With this configuration, the ultrasonic diagnostic device 1 of this embodiment can press the subject's body surface with a wide surface to give tension to the bladder, making it easier to capture the subject S. Here, since the body surface contact case 11A is only required to maintain its spherical shape, any material can be used, and in addition to various elastic bodies, hard plastics such as modified PP (polypropylene) can be used. Also, the body surface contact case 11A itself can be configured with polyurethane or gel pads having a spherical shape or the like on the outside (surface in contact with the body surface) in such a way that the inside fills the step between the first probe 111 and the second probe 112, in which case the gel or oil layer 11B is unnecessary, but this point will be described in detail in the section on modified examples. With this configuration, the ultrasound diagnostic device 1 of this embodiment can protect both the probes 111 and 112 provided on the installation surface 12A when the probe section 11 is brought into contact with the body surface of the subject S during observation and urine volume measurement, and can apply an appropriate pressure to the body surface when the probe section 11 is brought into contact with the body surface of the subject and pressed into the lower abdomen. Furthermore, if the body surface-contacting case 11A is made of a softer elastic material such as hard rubber and is provided with a gel or oil layer 11B, the body surface-contacting case 11A will deform appropriately together with the gel or oil layer 11B depending on the pressure applied when in contact with the body surface, making it possible to observe the subject S and measure the urine volume while applying uniform pressure to the subject's lower abdomen.In this embodiment, the body surface-contacting case 11A is provided to protect both probes 111 and 112, but the body surface-contacting case 11A is not necessary, and in this case, the first and second probes 111 and 112 come into direct contact with the body surface of the subject when capturing an ultrasonic diagnostic image. In this case, it is preferable to use, for example, a gel-like structure or the like that serves as a case, instead of the body surface-contacting case 11A.
[0066] [A3] Characteristics of the configuration of the probe section 11 Next, the features of the configuration of the probe unit 11 will be described with reference to Figures 6 to 8. Figure 6 is a diagram showing the relationship between the installation angles and installation positions of both probes 111 and 112 and the irradiation directions of the first and second sound beams SB1 and SB2 on the same side as the side view shown in Figure 3(B) (i.e., the side view seen from the direction of "B" in Figure 2(B)). FIG. 7 is a diagram showing the positional relationship of the subject S and the contact position and contact method of the ultrasound diagnostic device 1 when observing the subject S and measuring the urine volume. (A) shows the relationship between the contact position and orientation of the ultrasound diagnostic device 1 when observing, etc. (B) shows the anatomical positional relationship between (a) the subject S, (b) the first and second probes 111 and 112, and (c) the irradiation direction of the first and second sound beams SB1 and SB2 in a contact state in which the probe unit 11 is contacted with a standard-sized subject in the position and orientation shown in (A) so that the installation surface 12A is parallel or approximately parallel to a virtual tangent or tangent plane VT of the subject's body surface in an undeformed state (i.e., a contact state that satisfies the above-mentioned contact conditions (1) to (3)). (C) shows the anatomical positional relationship between the subject S, (b) the first and second probes 111 and 112, and (c) the irradiation direction of the first and second sound beams SB1 and SB2. 1A shows the anatomical positional relationship between (a) the subject S, (b) the first and second probes 111 and 112, and (c) the irradiation direction of the first and second sound beams SB1 and SB2 in a state in which the probe portion 11 is in contact with an obese subject in the position and orientation shown in FIG. 1A so that the installation surface 12A is parallel or approximately parallel to a virtual tangent or tangent plane VT of the subject's body surface in an undeformed state. FIG. 1D shows the anatomical positional relationship between (a) the subject S, (b) the first and second probes 111 and 112, and (c) the irradiation direction of the first and second sound beams SB1 and SB2 in a case in which the ultrasound diagnostic device 1 is in contact with an obese subject in the position and orientation shown in FIG. 1A and the subject S is observed or urine volume is measured.8A and 8B are diagrams showing the relationship between the orientation of the human body, the installation directions of the first probe 111 and the second probe 112, and the irradiation directions of the first and second sound beams SB1 and SB2 transmitted from each probe 111 and 112 in a state in which the probe unit 11 is in contact with the subject S at the position and orientation shown in FIG. 7A for observing the subject S or for measuring urine volume, so that the installation surface 12A is parallel or approximately parallel to a virtual tangent or tangent plane VT of the body surface in an undeformed state, with (A) showing the anatomical direction of the human body, (B) showing the relationship between the installation direction of the first probe 111 and the irradiation direction of the first sound beam SB1, and (C) showing the relationship between the installation direction of the second probe 112 and the irradiation direction of the second sound beam SB2. In FIG. 6, in order to facilitate understanding of the invention, the abutment state shown in FIG. 7 with respect to the front surface (ventral side) of the subject's body surface is shown formally (specifically, (1) the first scanning direction SD1 is maintained parallel or approximately parallel to the cross section of the subject's body so that the first probe 111 is closer to the head of the subject's body than the second probe 112 (corresponding to the above-mentioned abutment condition (1)), (2) the second scanning direction SD2 (i.e., the direction coinciding with the line segment connecting the center points of both ends of the second probe 112) is aligned with the median line of the subject's body (the above-mentioned abutment condition (2)), and (3) the installation surface 12A is aligned parallel or approximately parallel to a virtual tangent or tangent plane VT of the undeformed body surface. The caudal side of the subject's body in the contact state (contact condition (3) above) (see Figures 7(A) and (B)) is shown as the right side of the drawing, and the cranial side as the left side of the drawing. In addition, in Figures 6 to 8, the "+ direction" indicates the direction toward the cranial side of the subject's body in the contact state, and the "- direction" indicates the direction toward the caudal side of the subject's body in the contact state. Furthermore, in Figure 8, in order to make the invention easier to understand, the direction from the back of the drawing to the front of the drawing (i.e., the direction from the dorsal side to the ventral side of the subject's body) is shown as the normal direction ND, but in the actual contact state, the normal direction ND is the opposite direction to the normal direction shown in Figure 8 (i.e., the direction from the ventral side to the dorsal side of the subject's body).
[0067] Here, a characteristic feature of the present embodiment is that, in the above-mentioned contact state, the probe unit 11 of the present embodiment is arranged such that (1) the first probe 111 is disposed at a position on the cranial side of the subject's body as viewed from the second probe 112 (see FIG. 6). Meanwhile, (2) the second probe 112 is disposed at a position spaced a predetermined distance "l" from the installation position of the first probe 111 in the contact state to the caudal side of the subject's body as viewed from the installation position of the first probe 111 (see FIG. 6). In the present embodiment, the first probe 111 is installed so that, by performing electronic scanning in the first scanning direction SD1 in the contact state, the first sound beam SB1 inclined at an angle "θ1" is irradiated to the caudal side of the subject's body (i.e., the side where the second probe 112 is installed) as viewed from the normal direction ND (see FIG. 6) of the installation surface 12A. Specifically, in this embodiment, the first probe 111 is installed with a first rotation axis AR1 parallel to the first scanning direction SD1 as a center and tilted at an angle "θ1" toward the tail of the subject's body as viewed from the normal direction ND (see Figs. 6 and 8(B)). The first probe 111 performs electronic scanning in the first scanning direction SD1 in the above-mentioned abutting state, thereby transmitting a first sound beam SB1 that is tilted at an angle "θ1" toward the tail of the subject's body as viewed from the normal direction ND and is perpendicular to and intersects with the second sound beam SB2 (see Figs. 2 to 4, 6, and 8(B)). The first rotation axis AR1 is set as an axis parallel to the first scanning direction SD1 at the center of the transducer stand 111A of the first probe 111. With this configuration, when the ultrasonic diagnostic device 1 of this embodiment performs electronic scanning in the first scanning direction SD1 with the first probe 111 while the probe unit 11 is in contact so as to satisfy the above-mentioned contact conditions (1) to (3), the first sound beam SB1 can be obliquely irradiated from the front (ventral side) of the subject's body in the dorso-caudal direction, and the first sound beam SB1 can be appropriately irradiated to the center of the bladder behind the pubic bone while avoiding a reflecting object (i.e., the pubic bone) existing between the body surface and the subject S (see Figs. 7(B) and (D)). As a result, the ultrasonic diagnostic device 1 of this embodiment can appropriately image the maximum cross section of the subject S without being obstructed by the pubic bone. The specific value of the inclination angle "θ1" of the first sound beam SB1 will be described in detail later.
[0068] On the other hand, in this embodiment, the second probe 112 has a scanning direction (i.e., second scanning direction SD2) perpendicular to the first scanning direction SD1 as shown in FIG. 2, and transmits a second sound beam SB2 perpendicular to and intersecting with the first sound beam SB1 by performing electronic scanning in the second scanning direction SD2 (see FIGS. 1 to 4, 6, and 8(C)). Here, if the direction of the start or end point of the transmission angle range of the second sound beam SB2 is parallel to the normal direction ND, depending on the amount of urine in the bladder, the end of the imaged bladder longitudinal section may not be contained within the field angle range, and a part of it may be missing (see FIGS. 7(B) and (D)). On the other hand, if the transmission angle range of the second sound beam SB2 is widened without any ingenuity, the second sound beam SB2 may be reflected by the first probe 111, and the first probe 111 may be captured in the image. In particular, when the transverse and longitudinal sections of the bladder are to be simultaneously displayed on the display unit 17, if the transmission angle range of the second sound beam SB2 is too wide, it becomes difficult to ensure a display area for simultaneous display on the display unit 17. In this regard, the inventor's experiments have revealed that in order to allow the second sound beam SB2 to properly reach the entire longitudinal section of the bladder in an abutment state that satisfies the above abutment conditions (1) to (3), and to properly capture a longitudinal section image of the entire bladder, while simultaneously displaying the transverse and longitudinal sections of the bladder on the display unit 17, the following two conditions must be satisfied. <Condition 1> The angle "θ2" between the direction corresponding to either the starting point or the end point of the transmission range of the second sound beam SB2 (the starting point direction in the example shown in Figure 6) and the normal direction ND mentioned above must be set to be within an angle range of approximately "-65° to -80°" with respect to the normal direction ND (i.e., an angle range inclined by "65° to 80°" toward the caudal side of the subject's body when viewed from the normal direction). <Condition 2> The angle "θ3" between the direction corresponding to the other point (the end point direction in the example shown in Figure 6) and the normal direction ND needs to be set to be within an angle range of about +5° to +30° (i.e., an angle range inclined by 5° to 30° toward the head side of the subject's body when viewed from the normal direction ND).
[0069] Based on the above experimental results, in this embodiment, as shown in FIG. 6, (a) the angle "θ2" is set to about "-65°" (i.e., inclined to the tail side by about "65°" as viewed from the normal direction ND), and (b) the angle "θ3" is set to about "+30°" (i.e., inclined to the head side by about "30°" as viewed from the normal direction ND), and the transmission angle range of the second sound beam SB2 is set to about "-65° to +30°" in total by about "95°" (see FIG. 6 and FIG. 7(B), (C)). Note that in FIG. 6, in order to facilitate understanding of the invention, the point on the side defined by the angle "θ2" with respect to the normal direction ND is formally shown as the starting point direction of the second sound beam SB2, and the point on the side defined by the angle "θ3" is shown as the ending point direction, but the starting point direction and the ending point direction of the second sound beam SB2 shown in FIG. 6 may be interchanged, and the angle "θ2" side may be the ending point direction and the angle "θ3" side may be the starting point direction. In addition, in this embodiment, for the sake of concreteness, the transmission angle range of the second sound beam SB2 is described as being about "-65° to +30°" in total of about "95°", but the angles "θ2 and θ3" can be freely set within the range that satisfies the above conditions 1 and 2. Therefore, the transmission angle range of the second sound beam SB2 is a minimum transmission angle range of about "70°" from about "-65° to +5°" in total, and a maximum transmission angle range of about "110°" from about "-80° to +30°", and the transmission angle range of the second sound beam SB2 can be freely set within this angle range. With this configuration, the second sound beam SB2 is irradiated with a spread of "65°" in the dorsal-caudal direction and "30°" in the dorsal-cranial direction from the contact position above the pubic bone in the above-mentioned contact state (see Figs. 7B and 7C). As a result, according to the ultrasound diagnostic device 1 of this embodiment, when the probe portion 11 is brought into contact with the ventral side of the subject's body while satisfying the above-mentioned contact conditions (1) to (3) as shown in Figures 7(A) and (B), the second sound beam SB2 is appropriately irradiated to the entire longitudinal section of the bladder behind the pubic bone while avoiding the pubic bone, making it possible to depict and image the entire longitudinal section of the bladder regardless of the amount of urine in the bladder (see Figure 7(B)), and also making it easy to secure a display area on the display portion 17 for simultaneously displaying the transverse and longitudinal sections.The specific method for adjusting the angles "θ2 and θ3" between the directions that are the start and end points of the transmission range of the second sound beam SB2 and the normal direction ND is arbitrary, and for example, the following method can be adopted.
[0070] <Method 1> In this method, the second probe 112 itself is installed at an incline with respect to a direction parallel to the installation surface 12A so that the directions at which the transmission range of the second sound beam SB2 starts and ends are at angles "θ2 and θ3" with respect to the normal direction ND, as illustrated in Fig. 6. In this case, the second probe 112 may be installed at an incline with respect to a second rotation axis AR2 parallel to the installation surface 12A as the center so that the angles "θ2 and θ3" are approximately "+30°" and "-65°", respectively, as shown in Fig. 6 and Fig. 8(C). In this case, the second rotation axis AR2 may be set as an axis parallel to the installation surface 12A at the center of the transducer stand 111A of the second probe 112.
[0071] <Method 2> In this method, the second probe 112 is installed in a direction perpendicular to the direction parallel to the installation surface 12A (i.e., in a direction parallel to the normal direction) (see FIG. 16), and wiring is provided only to the transducer 111C-n that transmits the second sound beam SB2 in the transmission direction of the required beam, or a second drive signal is supplied only to the transducer 111C-n, so that the angles "θ2 and θ3" between the direction at the start and end of the transmission range of the second sound beam SB2 and the normal direction ND are adjusted to the desired angles (i.e., "-65°" and "+30°"). Other methods may also be adopted, but this point will be described in detail in the section on modified examples. With this configuration, even when the bladder is particularly full of urine, the second sound beam SB2 can reach the entire vertical section of the bladder, making it possible to capture an appropriate overall image of the vertical section. As mentioned above, the first probe 111 is placed at a distance "l" from the second probe 112 as a measure to prevent the second probe 112 from appearing in an image captured by the first probe 111 if the two probes 111 and 112 are brought too close to each other. Experiments by the inventor have shown that a distance "l" of about "3 mm" separating the two probes 111 and 112 is sufficient.
[0072] For this reason, in this embodiment, the distance "l" is set to "3 mm" and the second probe 112 is placed at a position "3 mm" caudal to the installation position of the first probe 111. Note that, in this embodiment, an example in which the distance "l" is "3 mm" is shown, but it has also been found that the distance "l" can be set arbitrarily as long as it is "0" or more by adjusting the heights of the first and second probes 111 and 112. This point will be described in detail in the section on modified examples. Furthermore, for example, the angles "θ1 to θ3" in this embodiment correspond to the "first to third angles" of the present invention, respectively.
[0073] Here, as shown in Figures 7(B), (C) and (D), the distance from the body surface to the center of the bladder changes depending on the body type of the subject. Therefore, the inventor's experiments have revealed that even if the probe portion 11 is brought into contact while satisfying the above-mentioned contact conditions (1) to (3) as shown in Figure 7, the conditions for appropriately irradiating the first sound beam SB1 to the cross section of the bladder change as follows. <Subjects with standard body type> In the case of a subject with a standard body type, the distance from the body surface to the center of the bladder is about 5 to 6 cm. Therefore, when the above-mentioned abutment conditions (1) to (3) are satisfied and the first probe 111 is abutted so as to be located about 5 to 6 cm above the pubic bone as shown in Fig. 7(A), (1) the distance from the incidence position of the first sound beam SB1 on the body surface to the suprapubic part of the subject's body surface and (2) the distance from the suprapubic part of the subject's body surface to the center of the bladder become almost equal, and the relationship of a right-angled isosceles triangle is established as shown in Fig. 7(B). Therefore, while maintaining the installation surface 12A parallel or approximately parallel to the virtual tangent or tangent plane VT of the body surface in an undeformed state as shown in Fig. 7(B), the probe unit 11 is brought into contact as shown in Fig. 7(A), and the irradiation angle "θ4" of the first sound beam SB1 with respect to the virtual tangent or tangent plane VT of the body surface in an undeformed state is set to "45°", and the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND is set to "-45°". It was found that the first sound beam SB1 can be appropriately irradiated to the entire cross section of the bladder at the center of the bladder and the maximum cross section of the bladder can be captured very easily for a subject of a standard body type by simply maintaining the contact state of Fig. 7 without adjusting the contact angle or the pushing amount (see Fig. 7(B)). At this time, the second sound beam SB2 is appropriately irradiated to the bladder longitudinal section without being obstructed by the pubic bone as shown in Fig. 7(B), and the longitudinal section of the bladder of the subject S can be appropriately imaged.
[0074] <Obese subjects> On the other hand, in the case of an obese subject, the distance from the body surface to the center of the bladder is greater than that of a normal-type subject (see Figs. 7(C) and (D)). Therefore, the value of the angle "θ4" for properly covering the entire cross section of the bladder center with the first sound beam SB1 is greater than the optimal value for a normal-type subject (i.e., "45°"). For example, as illustrated in Fig. 7(D), it has been found that for some obese subjects, the optimal value of the angle "θ4" between (a) the virtual tangent or tangential plane VT of the body surface in an undeformed state and (b) the irradiation direction SB1' of the first sound beam SB1 capturing the maximum cross section of the bladder (i.e., the direction in which the first sound beam SB1 is properly irradiated to the bladder center) is about "60°" (in other words, the optimal value of the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND is "-30°") (see Fig. 7(D)). Incidentally, except for morbidly obese subjects, it is known that the angle "θ4" for obese subjects generally falls within the range of approximately "60°±10°".
[0075] Based on the above experimental results, in this embodiment, a method of setting the angle "θ1" to "-45°" in accordance with a subject of standard build is adopted (see Figs. 7(B), (C) and (D)). When this configuration is adopted, in the above-mentioned contact state (i.e., while maintaining the installation surface 12A and the virtual tangent or tangent plane VT of the body surface in an undeformed state parallel or approximately parallel, the probe unit 11 is contacted with the body surface as shown in Fig. 7(A)), the first sound beam SB1 transmitted from the first probe 111 is obliquely irradiated to the body surface of the subject from a position about 5 to 6 cm above the pubic bone so that the angle "θ4" is "45°". At this time, in the case of (1) a subject of standard build, the first sound beam SB1 is appropriately irradiated to the center of the bladder as shown in Fig. 7(B). On the other hand, (2) in the case of some obese subjects, when the above-mentioned contact state (i.e., as shown in FIG. 7(C), while maintaining the virtual tangent or tangent plane VT of the installation surface 12A and the undeformed body surface in a parallel or nearly parallel state, contact is made as shown in FIG. 7(A), and the contact angle is not adjusted), the first sound beam SB1 is irradiated in a direction (the direction of "SB1" in FIG. 7(D)) shifted caudally by about "15°" (i.e., 60°-45°) from the direction (the direction of "SB1'" in FIG. 7(D)) for properly capturing the entire bladder cross section at the center of the bladder, as shown in FIGS. 7(C) and (D). Here, the angle "θ4" is different from the angle "θ1", and can be easily changed by simply adjusting the contact angle of the probe portion 11 with respect to the body surface. Specifically, by changing the angle of the probe unit 11 against the body surface of the subject in the above-mentioned contact state by about "15°" toward the head side as shown in Fig. 7(D) and adjusting the normal direction ND to coincide with the normal direction ND', the angle "θ4" can be changed from "45°" to "60°" and the irradiation direction of the first sound beam SB1 can be changed from the direction of "SB1" to the direction of "SB1'" in Fig. 7(D). Therefore, when this configuration is adopted, even for some obese subjects, the first sound beam SB1 can be appropriately irradiated to the bladder cross section at the center of the bladder simply by changing the contact angle by about "15°" toward the head side in the above-mentioned contact state (see Fig. 7(D)).As a result, according to this configuration, by fixing the inclination angle "θ1" of the first probe 111 with respect to the normal direction ND at "-45°", and simply adjusting the contact angle by about "15°" toward the head while visually checking the image displayed on the display unit 17, even for some obese subjects, it is possible to depict and capture an appropriate cross-sectional image without being obstructed by the pubic bone (see FIG. 7(D)). Note that the optimal values of the distance from the body surface to the bladder center and the angle "θ4" change depending on the obesity level of the subject, but by similarly adjusting the contact angle of the probe unit 11 with respect to the body surface in the above contact state, the angle "θ4" can be easily changed while keeping the angle "θ1" fixed at "-45°". Therefore, without changing the device configuration, it is possible to appropriately irradiate the first sound beam SB1 to the cross-section at the bladder center and appropriately image the maximum cross-section of the bladder by simply adjusting the contact angle for subjects of all body types.
[0076] Furthermore, when the contact angle is changed in this way, the irradiation range of the second sound beam SB2 is tilted by about "15°" toward the head side of the subject's body (see FIG. 7(D)), and the transmission angle range changes to about "-50° to +45°". However, except for morbidly obese subjects, the entire longitudinal section of the bladder falls within this angle range, so that an appropriate longitudinal section image can be captured together with the transverse section of the subject S without being obstructed by the pubic bone (see FIG. 7(D)). Furthermore, when the probe portion 11 is pressed into the body surface, the body surface is recessed, and the virtual tangent or tangent plane of the body surface is tilted from the virtual tangent or tangent plane VT of the body surface in an undeformed state. Therefore, the angle "θ4" changes by several degrees to a dozen degrees depending on the amount of pressing, but the change in the angle "θ4" can be absorbed by simply adjusting the angle at which the probe portion 11 is pressed. Therefore, the influence of the deformation of the body surface on the observation and urine volume measurement can be ignored. Furthermore, when the contact angle is changed, the installation surface 12A is no longer parallel or approximately parallel to the virtual tangent or tangent plane VT of the undeformed body surface, but the first and second sound beams SB1 and SB2 can be appropriately irradiated to the transverse and longitudinal sections of the bladder center by adjusting the contact angle while presetting the angles "θ1" to "-45°" and "θ2 and θ3" to "-65° and +30°" based on the above contact state. Therefore, the fact that the installation surface 12A and the virtual tangent or tangent plane VT of the undeformed body surface are no longer maintained parallel or approximately parallel when the contact angle is changed is not a problem in itself.
[0077] Here, in order to capture the images of the transverse and longitudinal sections of the subject S at the same position, it is essential that the first sound beam SB1 and the second sound beam SB2 are orthogonal and intersect with each other. For this reason, it is necessary to set the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND within the transmission angle range of the second sound beam SB2 (within the range of "+30° to -65°" in this embodiment). On the other hand, since the angle "θ1" is set to "-45°" in the case of this embodiment, the first sound beam SB1 is transmitted within the irradiation range of the second sound beam SB2, and the condition is satisfied. On the other hand, when the direction that is the start point or end point of the irradiation range of the second sound beam SB2 is expanded to a direction parallel to the installation surface 12A (i.e., when the angle "θ2=-90°"), even when the angle "θ1" is set to "-90°" (i.e., the tail side parallel to the installation surface 12A), the above condition is theoretically satisfied. Therefore, in this case, it is theoretically possible to prevent reflection by the pubic bone and to properly deliver the first sound beam SB1 to the subject S behind the pubic bone by tilting the ultrasound diagnostic device 1 significantly from the state in which the probe unit 11 of the ultrasound diagnostic device 1 is in contact with the subject's body surface (i.e., the angle "θ4") as shown in Fig. 7(A). However, when this method is adopted, it is necessary to tilt the contact angle of the ultrasound diagnostic device 1 by "90°" during observation of the subject S and urine volume measurement, which makes the operation during observation and urine volume measurement difficult. In addition, when this configuration is adopted, it becomes difficult for the operator to visually check the transverse and longitudinal cross-sectional images being captured and displayed on the display unit 17 during operation.In contrast, when the irradiation range of the second sound beam SB2 is set to about "95°" from "+30° to +65°" as shown in FIG. 6 and the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND is set to "-45°", by simply bringing the probe portion 11 into contact with the subject's body surface as shown in FIG. 7(A) and changing the angle at which the probe portion 11 is contacted with the subject's body surface by about "15°" toward the head while visually checking the images of the cross section and the longitudinal section displayed on the display portion 17 in the observation mode, it becomes possible to appropriately irradiate the first and second sound beams SB1 to the entire cross section and longitudinal section of the bladder at the center of the bladder even for obese subjects except for morbidly obese subjects, thereby appropriately observing the subject S, or to easily and quickly measure the urine volume while reducing the occurrence of personal errors due to the operator's experience. In addition, when observing tissues around the bladder other than the bladder or measuring the size parameters thereof, the display parameters such as focus, brightness, and display depth may be appropriately adjusted while adjusting the contact position and contact angle. Furthermore, in this embodiment, for the purpose of concrete explanation, an example is described in which the angle "θ1" is set to "-45°" according to a subject of a normal body type, but the angle "θ1" can be freely set within an angle range of about "-30° to -60°" according to an obese subject, a thin subject, etc. If the angle "θ1" is within this angle range, it falls within the transmission angle range of the second sound beam SB2, so that the above condition is satisfied and images of the transverse section and the longitudinal section of the subject S can be captured at the same position. Even in this case, by adjusting the contact angle of the probe portion 11 to the cranial or caudal side by about "15°" (i.e., "60°-45°" or "45°-30°"), subjects of normal body type can be covered, and even if "θ1=-30°" is set to suit some obese subjects, by adjusting the contact angle of the probe portion 11 to a maximum of about "30°" (i.e., "60°-30°"), observation of the subject S and urine volume measurement can be performed for all subjects including thin subjects, and the tissue around the bladder of subjects of all body types can be observed very easily and quickly, or urine volume measurement can be performed while preventing the occurrence of personal errors due to experience. Note that, for morbidly obese subjects, cases in which the angle "θ4" becomes large, such as "85°" and close to "90°", cannot be excluded.Therefore, in this case, the angle "θ1" can be set to about "-5°". However, when this method is adopted, the adjustment range of the contact angle becomes large for subjects other than morbidly obese subjects, making it difficult to observe the subject S and to operate the subject S during urine volume measurement. As a result, this method makes it difficult to quickly observe the tissue around the bladder while ensuring convenience, or to reduce the occurrence of personal errors due to the operator's experience during urine volume measurement. Therefore, it is desirable to set the angle "θ1" between "-30° to -60°". This configuration can narrow the adjustment range of the contact angle, so that it is possible to dramatically improve the convenience of the operator during imaging and urine volume measurement, while easily and quickly observing the subject S and reducing the occurrence of personal errors due to the operator's experience during urine volume measurement. On the other hand, when the angle "θ1" is set to "-45°" as in the present embodiment, the bladder can be theoretically visualized even for a morbidly obese subject by changing the contact angle to the head side by about "40°" (i.e., "85°-45°"). In any case, the adjustment range of the contact angle is about "40°" at most even for a morbidly obese subject, and the contact angle can be adjusted while visually checking the image displayed on the display unit 17. Therefore, by adopting this configuration, the operation can be simplified and the occurrence of personal errors due to the experience of the operator can be reduced. Note that the specific setting method of the angles "θ1 to θ3" with respect to the normal direction ND of the installation surface 12A is arbitrary, and it is desirable to set the angles "θ1 to θ3" to appropriate values while maintaining the installation surface 12A horizontally by placing the rectangular parallelepiped housing 12 on a table that is kept horizontal, for example. This method allows the first and second probes 111 and 112 to be easily and appropriately placed on the placement surface 12A as a horizontal plane so that the angles "θ1 to θ3" are the desired angles. Furthermore, when this method is employed, the operator can simply bring the probe section 11 into contact with the body surface so that the placement surface 12A is horizontal during use, so that the virtual tangent or tangential plane VT of the subject's body surface in an undeformed state is parallel or approximately parallel to the placement surface 12A, and the first and second sound beams SB1 and SB2 can be irradiated at a desired angle.
[0078] As a result, according to the configuration of this embodiment, while maintaining the virtual tangent or tangential plane VT of the undeformed subject's body surface and the installation surface 12A parallel or approximately parallel, the probe unit 11 is brought into contact with the body surface as shown in Fig. 7(A), and while visually checking the images of the transverse and longitudinal sections of the subject S displayed on the display unit 17, the angle at which the probe unit 11 is brought into contact with the body surface is changed by about "15°", and the first and second sound beams SB1 and SB2 can be appropriately irradiated to the bladder and tissues around the bladder as the subject S while avoiding the pubic bone, regardless of the body type of the subject, except for morbidly obese subjects. Also, for morbidly obese subjects, if the contact angle is adjusted to about "40°" toward the head in the contact state, the tissues around the bladder as the subject S can be appropriately imaged and the urine volume can be measured. In this case, the transmission angle range of the second sound beam SB2 changes by about "40°" toward the head side according to the change in the contact angle. However, even in this case, the entire longitudinal section of the bladder, which is the subject S, falls within the transmission angle range of the second sound beam SB2 as in the above case, so that the entire longitudinal section of the bladder can be properly depicted and imaged without being obstructed by the pubic bone. As a result, the ultrasound diagnostic device 1 of this embodiment can observe the subject S quickly while dramatically facilitating the operation of observing the subject S and measuring the urine volume compared to conventional ultrasound diagnostic devices, and can measure the urine volume easily, quickly, conveniently, and while preventing the occurrence of personal errors due to the experience of the operator. In this embodiment, a method for measuring the urine volume is exemplified as an example of a size parameter to be measured, but the measurement of size parameters other than the urine volume can also be simplified and speeded up.
[0079] [A4] Overview of operation of ultrasound diagnostic device 1 in each mode [A4-1] Overview of operation in observation mode First, the observation mode will be described. This mode is a default operation mode set when the power is turned on in the ultrasound diagnostic device 1 of this embodiment, and when the power is turned on, the ultrasound diagnostic device 1 transitions to this mode. When observing the subject S in this mode, first, the operator must adjust the position and orientation of the probe unit 11 to be abutted against the subject's body surface as shown in Fig. 7(A) so that the first and second sound beams SB1 and SB2 are appropriately irradiated onto the subject S, and abut the probe unit 11 so that the installation surface 12A and the virtual tangent or tangent plane VT of the undeformed body surface are parallel or approximately parallel. At this time, it is desirable that the control unit 19 (see FIG. 11), which will be described later, displays on the display unit 17 an image as exemplified in FIG. 7(A) along with lines, arrows, etc. showing the positions and orientations of both probes 111 and 112 (for example, the positions and orientations of the first and second scanning directions SD1 and SD2), and also displays text such as "In the orientation shown in the figure, bring the device into contact with the subject's body surface while keeping the line on the side of the device parallel to the surface, and after contact, input a command to start imaging.", thereby prompting the operator to input a command to start imaging while showing where and how to contact the probe unit 11 on the subject. Then, when the operator brings the probe unit 11 into contact with the line on the side of the device and the subject's body surface in the position and orientation illustrated in Fig. 7(A) so that the line is parallel or approximately parallel to the subject's body surface and performs an input operation to start imaging, the control unit 19 in the ultrasound diagnostic device 1, in conjunction with the driving unit 13 (see Fig. 11) described later, executes processing (see Fig. 12) for imaging and simultaneously displaying each image of the transverse section and the longitudinal section while alternately supplying input driving signals to the first probe 111 and the second probe 112. At this time, the control unit 19 alternately supplies driving signals to both the probes 111 and 112 so that each image of the transverse section and the longitudinal section is alternately imaged one frame at a time. As a result, both the probes 111 and 112 alternately transmit corresponding sound beams (i.e., the first sound beam SB1 and the second sound beam SB2) and receive echoes of the sound beams in the subject S.At this time, in the ultrasonic diagnostic device 1, the control unit 19 works in conjunction with the receiving unit 14 (see FIG. 11) described later to alternately generate cross-sectional image data and longitudinal image data corresponding to each ultrasonic diagnostic image frame of the cross section and the longitudinal section, store (buffer) them in the storage unit 16 described later, and display them side by side on the display unit 17. With this configuration, in the ultrasonic diagnostic device 1 in the observation mode, the cross-sectional image and the longitudinal section image captured substantially simultaneously are displayed side by side on the display unit 17. Thereafter, until a urine volume measurement instruction is given to the operation unit 15, the supply destination of the input drive signal is alternately switched for each frame image, and ultrasonic diagnostic images of the subject S are captured alternately in the order of cross section, longitudinal section, cross section, longitudinal section, etc. As a result, the display unit 17 continues to display the cross-sectional and longitudinal section ultrasonic diagnostic image frames captured substantially simultaneously side by side in a substantially synchronized manner. In this display state, the operator adjusts display parameters such as the direction of contact of the probe portion 11, the contact angle of the probe portion 11 with respect to the body surface, the amount of pressing of the probe portion 11 with respect to the body surface, the brightness level, the display depth, and the focus so that cross sections and longitudinal sections suitable for observation are captured, and continues imaging and observation of the ultrasound diagnostic images. The display parameters such as the brightness level may be adjusted by displaying a button for adjusting the display parameters together with the displayed image on the display unit 17, and changing the display parameters according to an input operation on the operation unit 15. At this time, the images of the cross sections and longitudinal sections displayed on the display unit 17 are updated and displayed sequentially at the frame update timing, so that the images of the cross sections and longitudinal sections captured approximately simultaneously are always maintained in a state in which they are displayed side by side simultaneously on the display unit 17. The display images are updated at a frame rate of, for example, 100 msec (milliseconds) when the frame rate is 10 fps (frames per second), so that the images of the cross sections and longitudinal sections captured approximately simultaneously are visually recognized as if they were displayed simultaneously without any sense of incongruity. As a result, in the observation mode, the operator can adjust the contact angle to a suitable angle for observation while checking the image displayed on the display unit 17 (see FIG. 7), and capture ultrasound diagnostic images of the transverse and longitudinal sections of the subject S suitable for observation to be used for diagnosis. At the same time, the operator can easily and quickly capture transverse and longitudinal images suitable for urine volume measurement while adjusting the contact angle.During urine volume measurement, the operation mode is switched to the urine volume measurement mode when a urine volume measurement instruction is given, whereas during observation of the subject S, an instruction to end imaging is input when the observation is completed, and imaging and simultaneous display processing are terminated. In this case, it is desirable to provide a screen capture function that, when the operator performs a predetermined input operation at the time when a desired ultrasound diagnostic image is displayed, extracts transverse section image data and longitudinal section image data corresponding to the image frame captured and displayed at that time, stores them in the storage unit 16, and maintains them in a state that can be used later.
[0080] [A4.2] Overview of operation in urine volume measurement mode Next, an outline of the operation of the ultrasonic diagnostic device 1 in the urine volume measurement mode will be described. When measuring the amount of urine in the subject's bladder in the urine volume measurement mode, the operator must first adjust the direction in which the probe unit 11 is brought into contact and the contact angle of the probe unit 11 with respect to the body surface so that the first and second sound beams SB1 and SB2 are appropriately irradiated onto the subject S in order to capture images of the cross section and the longitudinal section suitable for urine volume measurement. For this reason, in this embodiment, the operator must adjust the contact angle while capturing and checking the cross section and the longitudinal section of the subject S in the observation mode before measuring the amount of urine (see FIG. 7), and input a urine volume measurement command to the operation unit 15 when the cross section and the longitudinal section suitable for urine volume measurement are ready to be captured. When the operator issues a urine volume measurement instruction to the operation unit 15, the control unit 19 transitions from the observation mode to the urine volume measurement mode, executes a urine volume measurement process described later, measures the bladder volume (urine volume) of the subject, and simultaneously displays the measurement result of the urine volume on the display unit 17 together with the images of the transverse and longitudinal sections used in the measurement. Generally, when observing the bladder using an ultrasound diagnostic system or the like, the cross-sectional area of the bladder reflected in the transverse section image increases or decreases depending on the angle at which the ultrasound diagnostic image processing probe device is brought into contact with the subject and the amount of depression. Therefore, in order to properly measure the urine volume in the bladder, it is desirable to use a frame in which the maximum cross section of the bladder is reflected in the ultrasound diagnostic image frame group corresponding to each cross section and longitudinal section imaged during a specified imaging period.
[0081] Therefore, in the ultrasound diagnostic device 1 of this embodiment, when a urine volume measurement instruction is given and the device transitions to a urine volume measurement mode, ultrasound diagnostic image frames of transverse and longitudinal sections are captured for a predetermined imaging setting time period "α" (e.g., 2 seconds), and the urine volume is measured using the ultrasound diagnostic image frame in which the bladder is most prominently captured among the images of the transverse and longitudinal sections captured during that period, and the ultrasound diagnostic image frame used for the measurement and the urine volume measurement result are simultaneously displayed on the display unit 17 (see FIG. 14). With this configuration, the ultrasound diagnostic device 1 of this embodiment allows the operator to simultaneously check the urine volume measurement value and the state of the bladder at that time, improving the convenience for the operator.
[0082] [A5] Principle of urine volume measurement Next, the measurement principle when measuring the amount of urine in the subject's bladder using the ultrasound diagnostic device 1 of this embodiment will be described with reference to Figs. 9 and 10. Figs. 9 and 10 are diagrams for explaining the measurement principle when measuring the amount of urine in the bladder from a cross-sectional image and a longitudinal image of the bladder of the subject S, respectively. Also, in Figs. 9 and 10, (A) shows an anatomical diagram, (B) shows the scanning direction by the ultrasound diagnostic device 1 when measuring the amount of urine, and (C) shows the cross-sectional image and the longitudinal image that are actually captured. Furthermore, in Fig. 10, (D) shows an anatomical diagram viewed from the same direction as the longitudinal image in order to easily grasp the positional relationship between the image and the organ.
[0083] (1) Method for measuring the bladder diameter As shown in Figures 9(B) and 10(B), the probe portion 11 is brought into contact with the subject's bladder (subject S) at the position and orientation shown in Figure 7(A) so that it is symmetrical about the midline of the subject's body, while being kept parallel or approximately parallel to the imaginary tangent or tangent plane VT of the undeformed body surface, and input drive signals are supplied alternately to both probes 111 and 112, so that (1) the first probe 111 alternately irradiates the first sound beam SB1 to the transverse section of the bladder, and (2) the second probe 112 alternately irradiates the second sound beam SB2 to the longitudinal section of the bladder. At this time, in the ultrasound diagnostic device 1, the control unit 19, in cooperation with the receiving unit 14, (1) generates cross-sectional image data corresponding to a cross-sectional image frame of the bladder as shown in FIG. 9C based on the echo from the bladder of the first sound beam SB1, and (2) generates longitudinal image data corresponding to a longitudinal image frame of the bladder as shown in FIG. 10C based on the echo from the bladder of the second sound beam SB2, one frame at a time, alternately and stores the data in the storage unit 16. For example, when the sound beams SB1 and SB2 are alternately transmitted by both probes 111 and 112 from time t1 to time T1 after the elapse of the imaging setting time "α" to image the cross-sectional and longitudinal sections of the bladder alternately for each frame, in the ultrasound diagnostic device 1, each image frame of the cross-sectional and longitudinal sections is alternately imaged between time t1 and time T1, and the cross-sectional image data and longitudinal image data generated by the control unit 19 are sequentially stored in the storage unit 16 and maintained in a state available for measurement of urine volume and image display. At this time, the operator needs to adjust the contact angle of the probe portion 11 with respect to the body surface as described above so that an appropriate cross-sectional image is captured as exemplified in FIG. 7(D).
[0084] In each transverse-sectional image frame (FIG. 9(C)) captured at this time, the maximum diameter "a" indicated by the blue dotted line in the long axis direction indicates the left-right diameter (inner diameter) of the bladder, and the maximum diameter "c" indicated by the yellow dotted line in the short axis direction perpendicular to the long axis indicates the up-down diameter (inner diameter) of the bladder. For this reason, in this embodiment, the control unit 19 performs an image region extraction process (see FIG. 15) on the transverse-sectional image data corresponding to each transverse-sectional image frame stored in the storage unit 16, thereby extracting an image region in which the bladder is reflected in each transverse-sectional image frame for each transverse-sectional image frame. Then, the control unit 19 measures the maximum diameters in the long axis and short axis directions of the image region to measure the left-right diameter "a" and the up-down diameter "c" of the bladder and stores them in the storage unit 16. The image region extraction process will be described in detail in the section on operation.
[0085] (2) Method for measuring the anterior-posterior and superior-inferior diameters of the bladder In each longitudinal image frame (FIG. 10(C)) captured at this time, the maximum diameter "b" indicated by the blue dotted line in the long axis direction indicates the anterior-posterior diameter (inner diameter) of the bladder, and the maximum diameter "c" indicated by the yellow dotted line in the short axis direction perpendicular to this dotted line indicates the up-down diameter of the bladder. For this reason, in this embodiment, the control unit 19 performs an image area extraction process on the longitudinal image data corresponding to each longitudinal image frame stored in the storage unit 16, and extracts an image area in which the bladder is captured in each longitudinal image frame for each frame. Then, the control unit 19 measures the anteroposterior diameter "b" and the up-down diameter "c" of the bladder by measuring the maximum diameters in the long axis and short axis directions of the image area, and stores the measurement results in the storage unit 16. In this embodiment, the measurement condition data defining the measurement criteria of each diameter "a", "b" and "c" may be configured to be stored in the storage unit 16 in advance.
[0086] Generally, the amount of urine in the bladder is calculated by the following formula 1. Intravesical urine volume (mL)=(a×b×c) / 2(cm) (Formula 1) In addition, "a", "b" and "c" respectively indicate the left-right diameter, the front-back diameter and the up-down diameter of the bladder. In addition, since the up-down diameter "c" is basically the same value in the transverse section image and the longitudinal section image for the bladder, it is arbitrary whether the up-down diameter "c" is measured based on the vertical or horizontal section image frame. However, in this embodiment, for the purpose of concrete explanation, only the left-right diameter "a" is measured from the transverse section image frame, and the front-back diameter "b" and the up-down diameter "c" are measured from the longitudinal section image frame. Furthermore, the above formula 1 is merely an example of a urine volume calculation formula, and calculation formulas other than formula 1 may be used.
[0087] In this embodiment, the control unit 19 calculates the amount of urine in the subject's bladder by substituting the measured values of "a", "b" and "c" into Equation 1. Note that (1) the timing of extracting the image area in which the subject S appears from the ultrasound diagnostic image data corresponding to the transverse and longitudinal sections and (2) the timing of measuring the diameters of the subject S in each direction (i.e., "a", "b" and "c") based on the extracted image area are arbitrary, and the image area in which the subject S appears is extracted from the transverse cross-sectional image once between the timing of completion of scanning in the transverse direction (first scanning direction SD1) and the timing of starting scanning in the vertical direction (second scanning direction SD2), and the left and right diameters are measured from the image area included in the transverse cross-sectional image based on the extracted image area. Alternatively, the system may be configured to measure "a" and store the measurement result in the storage unit 16, and then move to vertical scanning. Alternatively, the system may be configured to alternately repeat horizontal and vertical scanning for a predetermined period (e.g., imaging setting time "α"), generate and buffer ultrasound diagnostic image data corresponding to each of the transverse and longitudinal sections obtained by each scan for the imaging setting time "α", and then extract image areas in which the subject S is captured from the ultrasound diagnostic image data corresponding to each of the transverse and longitudinal images, and measure the values of each of the diameters "a", "b", and "c" at once. However, in this embodiment, in order to make the explanation concrete, the former method is adopted. In addition, the measurement values of each of the diameters "a", "b", and "c" may be average values of "a", "b", and "c" measured based on each transverse and longitudinal image frame captured during a predetermined imaging period, but in this embodiment, a method is adopted in which the maximum measurement value measured based on each frame is used for the above-mentioned reasons.
[0088] [A6] Configuration of Ultrasound Diagnostic Device 1 Next, the configuration of the ultrasonic diagnostic device 1 of this embodiment will be described with reference to Fig. 11. Fig. 11 is a block diagram showing an example of the functional configuration of the ultrasonic diagnostic device 1 of this embodiment, and each unit shown in Fig. 11 is basically configured to be installed inside the housing 12, except for the probe unit 11, the display unit 17, and the operation unit 15.
[0089] 11, the ultrasonic diagnostic device 1 of this embodiment includes a probe unit 11 having the above-mentioned configuration provided on the bottom side of a housing 12, (1) a drive unit 13, (2) a receiver 14, (3) an operation unit 15 configured with a touch panel installed on a display unit 17, (4) a storage unit 16, (5) a display unit 17 installed on the top side of the housing 12 and configured with a liquid crystal display or an organic EL (Electro Luminescence) display and a drive circuit for the display, (6) a communication unit 18 configured with a communication chip, connector, antenna, etc. of a wired communication interface such as USB (Universal Serial Bus) or a wireless communication interface such as IEEE (Institute of Electrical and Electronics Engineers) 802.11a, b, g, n, ac, ax, Bluetooth (registered trademark), and communicatively connected to an external device 2 such as a PC (personal computer), and (7) a control unit 19. Each unit is configured to receive power required for driving from a built-in battery (not shown). For example, the first probe 111 and the second probe 112 in this embodiment cooperate with the drive unit 13 and the receiver unit 14 to constitute the "first ultrasonic transmission / reception means" and the "second ultrasonic transmission / reception means" of the present invention, and the drive unit 13 cooperates with the signal processing unit 191 to constitute, for example, a "drive means."
[0090] The driving unit 13 is composed of circuits such as an amplifier, and under the control of the control unit 19, generates a driving signal while amplifying the transmission signal supplied from the signal processing unit 191, and (1) supplies the driving signal to the first probe 111 as a first input driving signal, and (2) supplies the driving signal to the second probe 112 as a second input driving signal. As a result, (1) in the first probe 111, the transducer array 111C performs electronic scanning in the first scanning direction SD1 and transmits a first sound beam SB1. Meanwhile, (2) in the second probe 112, the transducer array 111C performs electronic scanning in the second scanning direction SD2 and transmits a second sound beam SB2.
[0091] The receiving unit 14 has an amplifier for amplifying the output signals supplied from the probes 111 and 112 of the probe unit 11, an A / D (analog / digital) converter, etc., and converts the output signals supplied from the probes 111 and 112 into digital signals and supplies them to the signal processing unit 191, the control unit 192, and the image processing unit 193. The amplifier built into the receiving unit 14 is capable of changing the amplification factor under the control of the control unit 192, and the control unit 192, which will be described later, is capable of changing the brightness level of the ultrasound diagnostic image by changing the amplification factor of the amplifier.
[0092] The storage unit 16 is configured by combining a NAND or NOR type flash memory, a ROM (read only memory), a RAM (random access memory), and the like. The storage unit 16 stores a program for the control unit 19 to execute processes corresponding to the above two operation modes. The storage unit 16 also stores in advance (1) extraction condition data indicating extraction conditions such as a shape model of the bladder used when extracting an image area in which the bladder is reflected from the ultrasound diagnostic image frames of the transverse and longitudinal sections in the measurement mode, and (2) measurement condition data corresponding to conditions when measuring urine volume (for example, information indicating the measurement conditions of "a", "b", and "c" in Figs. 2 and 3(C) and information such as Equation 1). The storage unit 16 is used to store ultrasound diagnostic image data and various measurement values, and is also used as a work area when each of the units 191 to 193 of the control unit 19 executes various processes. For example, the storage unit 16 in this embodiment constitutes the "storage means" of the present invention. In addition, it is preferable that the storage unit 16 is configured to temporarily record the extracted ultrasound diagnostic image data when extracting an ultrasound diagnostic image frame captured at the timing when a screen capture operation is performed. Furthermore, the programs stored in the storage unit 16 may be partially omitted when the control unit 19 is configured to execute a program pre-installed on a circuit such as an FPGA (field programmable gate array).
[0093] The control unit 19 is configured with, for example, an MPU (Micro Processing Unit), an ultrasonic processing LSI (Large Scale Integration), an FPGA, an ASIC (Application Specific Integrated Circuit), etc., and also includes a timer (not shown). The control unit 19 realizes a signal processing unit 191, a control unit 192, and an image processing unit 193 by executing processing based on a program recorded in the storage unit 16, or by executing processing preprogrammed on a circuit.
[0094] (Signal processing unit 191) The signal processing unit 191 controls electronic scanning by sound waves based on a control command supplied from the control unit 192 in response to an input operation by the operator on the operation unit 15. For example, when an input operation to start imaging is performed on the operation unit 15, the signal processing unit 191 starts supplying a transmission signal to the driving unit 13 and causes the probe unit 11 to start electronic scanning by sound waves. At this time, the signal processing unit 191 operates in the observation mode, which is a default mode, while alternately capturing images of transverse and longitudinal cross sections of the bladder, which is the subject S, one frame at a time. In order to do so, the signal processing unit 191 alternately supplies driving signals to both probes 111 and 112 in conjunction with the driving unit 13, and causes the first and second sound beams SB1 and SB2 to be transmitted alternately from both probes 111 and 112. The signal processing unit 191 also performs processing such as filtering on the digital data supplied from the receiving unit 14 and supplies the result to the image processing unit 193. When the urine volume is measured by the ultrasonic diagnostic device 1 of this embodiment, the control unit 19 transitions to a urine volume measurement mode when a urine volume measurement instruction is given, and the signal processing unit 191, in cooperation with the driving unit 13, alternately supplies drive signals to both probes 111 and 112 during a predetermined imaging setting time "α" from the input timing of the urine volume measurement instruction, and performs filtering processing on the digital data and supplies it to the image processing unit 193. Then, when the imaging setting time "α" has elapsed, the supply of input drive signals to each of the probes 111 and 112 is stopped, and the filtering processing is stopped. On the other hand, when the subject S is being observed, the signal processing unit 191 may stop the supply of drive signals to both probes 111 and 112 and the filtering processing when an instruction to stop imaging is input to the operation unit 15, and end the simultaneous display of the transverse section and the longitudinal section.
[0095] (Control Department 192) The control unit 192 switches the operation mode in response to the input operation of the operator on the operation unit 15, supplies control commands to each part of the ultrasound diagnostic apparatus 1, and performs integrated control of each part of the ultrasound diagnostic apparatus 1. The control unit 192 also supplies measurement history data generated by an image processing unit 193 (described later) and stored in the storage unit 16 to the external device 2 as necessary while linking with the communication unit 18. At this time, the control unit 192 may supply ultrasound diagnostic image data (which may include an ultrasound diagnostic image frame or audio data from which a part is extracted) of the subject to the external device 2 together with the measurement history data or as a part of the measurement history data. Furthermore, the control unit 192 causes the display unit 17 to display various instructions for the operator, and also causes the display unit 17 to display various buttons such as "start imaging", "urine volume measurement", "stop imaging", and "screen capture" as well as buttons for adjusting display parameters, and controls each part of the ultrasound diagnostic apparatus 1 in response to the input operation of the operator according to the display.
[0096] (Image processing unit 193) Under the control of the control unit 192, the image processing unit 193 realizes the following functions 1 to 4.
[0097] <Function 1> The image processing unit 193 executes a process of generating ultrasonic diagnostic image data obtained by capturing an image of the subject S based on data supplied from the signal processing unit 191, while buffering the data in the storage unit 16. At this time, the image processing unit 193 (1) generates cross-sectional image data of the subject S based on the echo of the first sound beam SB1 in the subject S when the subject S is scanned in the first scanning direction SD1 (horizontal) by the first sound beam SB1 transmitted from the first probe 111, and (2) generates longitudinal image data of the subject S based on the echo of the second sound beam SB2 in the subject S when the subject S is scanned in the second scanning direction SD2 (vertical) by the second sound beam SB2 transmitted from the second probe 112, and buffers the generated cross-sectional image data and longitudinal image data in the storage unit 16. Note that, for example, the image processing unit 193 of this embodiment realizes a function as the "generating means" of the present invention by this function in conjunction with the receiving unit 14 and the signal processing unit 191.
[0098] <Function 2> The image processing unit 193 executes an image region extraction process based on the ultrasound diagnostic image data buffered in the storage unit 16. At this time, the image processing unit 193 executes the image region extraction process based on the extraction condition data stored in the storage unit 16, and extracts an image region in which the bladder is captured based on the ultrasound diagnostic image data corresponding to each of the transverse and longitudinal sections. Note that, for example, the image processing unit 193 of this embodiment realizes the function as the "extraction means" of the present invention by this function.
[0099] <Function 3> Based on the image area extracted by the image area extraction process and the measurement condition data stored in the storage unit 16, the image processing unit 193 measures the left-right diameter "a" of the subject S (bladder) from the transverse image frame according to the above principle, and also measures the anterior-posterior diameter "b" and the superior-subordinate diameter "c" from the longitudinal image frame, and stores the measurement results in the storage unit 16. Then, the image processing unit 193 calculates the bladder volume while substituting the measurement values of the diameters "a", "b" and "c" stored in the storage unit 16 into Equation 1, and stores the calculated value in the storage unit 16 as the measurement result of the urine volume. At this time, the image processing unit 193 specifies the current date and time using a timer (not shown), and generates measurement history data by associating (A) date and time information indicating the specified date and time, (B) a subject ID for uniquely identifying the subject whose urine volume is to be measured, and (C) the measurement result of the urine volume, and stores the data in the storage unit 16, thereby building a database of measurement history data in the storage unit 16. Then, the control unit 192 supplies the data in the database to the external device 2 via the communication unit 18 as necessary. Note that, for example, the image processing unit 193 of this embodiment realizes the function of the "measurement means" of the present invention by this function. Also, the measurement history data may include image frames of the transverse and longitudinal sections used for the measurement.
[0100] <Function 4> The image processor 193, in cooperation with the control unit 192, causes the display unit 17 to display the images of the cross section and the longitudinal section taken at substantially the same time using the first and second probes 112 side by side in the observation mode. On the other hand, in the measurement mode, the images of the cross section and the longitudinal section used in the measurement are displayed simultaneously together with the measurement result of the urine volume. In the measurement mode, the measurement results of the diameters "a", "b", and "c" may be displayed simultaneously together with the measurement result of the urine volume. In this case, a display format may be adopted in which the operator is presented with lines and arrows as shown in FIG. 9(C) and FIG. 10(C) for the images of the cross section and the longitudinal section used in the measurement to indicate to which part the measurement value of each diameter corresponds. In addition, for example, the image processor 193 of this embodiment realizes the function as the "display control means" of the present invention by this function.
[0101] [A7] Operation of ultrasound diagnostic device 1 Next, the processing executed by the control unit 19 in the ultrasound diagnostic apparatus 1 of this embodiment will be described with reference to Figs. 12 to 15. Fig. 12 is a flowchart showing the processing executed by the control unit 19 of this embodiment in the observation mode, Fig. 13 is a flowchart showing the urine volume measurement processing executed by the control unit 19 after transition to the urine volume measurement mode, Fig. 14 is a diagram showing an example of an image displayed on the display unit 17 in the urine volume measurement mode, and Fig. 15 is a flowchart showing the image region extraction processing executed by the image processing unit 193.
[0102] (1) Processing in observation mode First, the process executed by the control unit 19 in the present embodiment in the observation mode will be described with reference to FIG.
[0103] As shown in Fig. 12, in the control unit 19 under the observation mode, first, the control unit 192, while interlocking with the display unit 17, displays an image as shown in Fig. 7(A) on the display unit 17 along with a character string such as "Keep the line of the side part of the device parallel or approximately parallel to the body surface, and abut as shown in the display diagram. After abutment, please input the subject ID and input an instruction to start imaging.", and prompts the operator to input the subject ID and an instruction to start imaging while presenting where and how to abut the probe unit 11 on the subject. At this time, the control unit 192 also displays a "Start imaging" button, an input box for inputting the subject ID, and a "Decision" button (step S1), and when the operator inputs the subject ID corresponding to the subject and selects the "Decision" button (step S2), the control unit 192 transitions to a state of waiting for the operator to select and input the "Start imaging" button (step S3 "No"). In this state, the operator follows the display on the display unit 17 to orient the probe unit 11 as shown in FIG. 7(A) so that (1) the first scanning direction SD1 is parallel or approximately parallel to the cross section of the subject's body part, (2) the second scanning direction SD2 coincides with the midline of the subject's body part, and (3) the line on the side of the housing 12 is maintained approximately parallel to the virtual tangent or tangent plane VT of the undeformed body surface so that the installation surface 12A is parallel or approximately parallel to the virtual tangent or tangent plane VT of the undeformed body surface, and the first probe 111 is abutted symmetrically against the midline so as to be 5 to 6 cm above the subject's pubic bone (see FIG. 7), and then performs an input operation to select the "Start imaging" button (step S3 "Yes"), which causes the signal processing unit 191 to first supply a first input drive signal to the first probe 111 in conjunction with the drive unit 13. As a result, electronic scanning in the first scanning direction SD1 is performed in the first probe 111, and the first sound beam SB1 is transmitted. At this time, the first sound beam SB1 is transmitted in the dorso-caudal direction while being inclined at an angle "θ1" (-45°) with respect to the normal direction ND as shown in Fig. 6 and Fig. 8(B), and is irradiated onto the bladder behind the pubic bone (see Figs. 7(B) and (D)), and the echo of the first sound beam SB1 at the bladder is received by the first probe 111.As a result, a first output signal corresponding to the echo is output from the first probe 111 to the receiving unit 14, which converts the signal into digital data and supplies the digital data to the signal processing unit 191. The signal processing unit 191 filters the digital data and then supplies the digital data to the image processing unit 193. Based on the digital data, the image processing unit 193 generates transverse sectional image data corresponding to the first transverse sectional image frame of the bladder, and stores the data in the storage unit 16 (step S4). When the transverse sectional image data corresponding to the first transverse sectional image frame is stored in the storage unit 16 in this manner, the signal processing unit 191, in cooperation with the driving unit 13, supplies a second input drive signal to the second probe 112 to change the scanning direction by 90°. As a result, the second probe 112 performs electronic scanning in the second scanning direction SD2, and transmits a second sound beam SB2 that is perpendicular to the first sound beam SB1 and intersects with the first sound beam SB1 (see FIGS. 1 to 4 and 8). At this time, the second sound beam SB2 is transmitted so that the transmission angle range is "+30 to 65°" totaling "95°" as shown in Fig. 6, and is irradiated to the bladder. As a result, an echo of the second sound beam SB2 in the bladder is received by the second probe 112, and a second output signal corresponding to the echo is output from the second probe 112 to the receiving unit 14. The receiving unit 14 converts the second output signal into digital data, and then supplies it to the signal processing unit 191. After filtering, the data is supplied to the image processing unit 193. Based on this data, the image processing unit 193 generates longitudinal section image data corresponding to the first longitudinal section image frame in which the bladder is imaged, and stores the data in the storage unit 16 (step S5). When the image data of the transverse and longitudinal sections corresponding to the first transverse and longitudinal image frames, respectively, are stored in the memory unit 16 in this manner, the image processor 193, in cooperation with the control unit 192, causes the display unit 17 to simultaneously display the first transverse and longitudinal image frames side by side based on the image data (step S6). At this time, it is desirable to display a "urine volume measurement" button, a "stop imaging" button, and buttons for adjusting display parameters together with these images.Then, when a urine volume measurement instruction is given according to this display (step S7 "Yes"), the image processor 193 transitions to a measurement mode and executes a urine volume measurement process (step S8), and then ends the process.
[0104] On the other hand, if the result of the determination in step S7 is "No", the process returns to step S4, and in order to capture the next cross-sectional image frame (second frame), the image processing unit 193, in conjunction with the signal processing unit 191 and the driving unit 13, supplies a first input driving signal to the first probe 111, generates cross-sectional image data corresponding to the next cross-sectional image frame, and stores it in the memory unit 16.
[0105] Next, the signal processing unit 191, in cooperation with the image processing unit 193 and the driving unit 13, supplies a second input driving signal to the second probe 112 to capture the next longitudinal image frame (second frame), generates corresponding longitudinal image data, and stores it in the storage unit 16 (step S5). The image processing unit 193, in cooperation with the control unit 192, updates the display image with the image data of the next transverse image frame and the longitudinal image frame thus stored in the storage unit 16, and simultaneously displays both image frames side by side (step S6). It determines whether or not a urine volume measurement instruction has been issued (step S7). If it determines "Yes", it transitions to a urine volume measurement mode, executes a urine volume measurement process (step S8), and ends the process. On the other hand, if it determines "No" in step S7, it returns the process to step S4 again, and transitions to capturing the next transverse image frame (third frame). Thereafter, the process of steps S4 to S7 is repeated until a urine volume measurement instruction is given, and the display is updated with the transverse and longitudinal image frames captured at approximately the same time (step S6). When a urine volume measurement instruction is given (step S7), the mode is switched to a urine volume measurement mode, and the urine volume measurement process is executed (step S8), and the process is terminated. When observing the subject S, it is determined whether or not an instruction to "stop imaging" has been input in step S7, and the process may be terminated when the instruction to "stop imaging" is given, or the process of steps S4 to S7 may be terminated when the power supply of the ultrasound diagnostic device 1 is turned off. In addition, while the above series of processes (steps S4 to S7) are repeated and the transverse and longitudinal images of the subject S are simultaneously displayed on the display unit 17, the operator observes the subject S while adjusting the angle at which the probe unit 11 is brought into contact with the subject's body surface, the amount of pressing, etc. (see FIG. 7) so that an image suitable for bladder observation and urine volume measurement is captured, or issues a urine volume measurement instruction when an image suitable for urine volume measurement is captured.
[0106] (2) Urine volume measurement processing Next, a urine volume measurement process executed by the control unit 19 of this embodiment when the mode is changed to the urine volume measurement mode will be described with reference to FIG.
[0107] 13, in the urine volume measurement process, for example, ultrasound diagnostic image frames of transverse and longitudinal sections are captured for a predetermined imaging setting time "α" (for example, 2 seconds) from time t1, and imaging is terminated at time T1. In order to extract an ultrasound diagnostic image frame in which the bladder is most prominent among the ultrasound diagnostic images captured between times t1 and T1, the image processor 193 first sets a counter "N" for counting the number of times a frame is captured to "0" and maintains a state in which the number of imaging times can be counted (step Sa1). For example, when the imaging setting time "α" is set to 2 seconds and the images of the transverse and longitudinal sections are each captured at a frame rate of 10 fps (frames per second), the image processor 193 may be set in conjunction with the control unit 192 to complete scanning and imaging when the counter reaches "20". On the other hand, in this state, the signal processing unit 191, in cooperation with the driving unit 13 and the control unit 192, first supplies a first input driving signal to the first probe 111, and transmits a first sound beam SB1 from the first probe 111. As a result, an echo of the first sound beam SB1 in the bladder is received by the first probe 111, and digital data corresponding to the echo received by the first probe 111 is supplied from the receiving unit 14 to the signal processing unit 191, and after filtering processing in the signal processing unit 191, it is supplied to the image processing unit 193. The image processing unit 193 generates cross-sectional image data corresponding to the first cross-sectional image frame in which the bladder is imaged based on this data, and stores it in the storage unit 16 (step Sa2). Note that the operation at this time is basically the same as step S4 in FIG. 12.
[0108] Next, the image processor 193 performs an image region extraction process on the data of the first transverse image frame stored in the memory unit 16 (step Sa3), measures the left-right diameter "a" of the bladder captured in the transverse image frame (see FIG. 9(C)), and assumes that the measured value "a" of the left-right diameter is the maximum value of the bladder left-right diameter "a" in the series of transverse image frames captured during the set imaging time "α", and associates it with the subject ID and the corresponding transverse image data and stores it in the memory unit 16 (step Sa4). At this time, the image processor 193 measures the maximum diameter in the long axis direction measured from the image region captured by the bladder extracted in the image region extraction process as the left-right diameter "a" of the bladder.
[0109] Next, the signal processing unit 191, in cooperation with the driving unit 13 and the control unit 192, supplies a second input driving signal to the second probe 112, and transmits a second sound beam SB2 from the second probe 112. As a result, an echo of the second sound beam SB2 in the bladder is received by the second probe 112, and digital data corresponding to the echo received by the second probe 112 is supplied from the receiving unit 14 to the signal processing unit 191, and after filtering processing in the signal processing unit 191, it is supplied to the image processing unit 193. Based on this data, the image processing unit 193 generates longitudinal section image data corresponding to the first longitudinal section image frame in which the bladder is imaged, and stores it in the storage unit 16 (step Sa5). Note that the operation at this time is basically the same as step S5 in FIG. 12.
[0110] Next, the image processing unit 193 performs an image area extraction process on the longitudinal image data of the first longitudinal image frame stored in the memory unit 16 (step Sa6), measures the anterior-posterior diameter "b" and the superior-inferior diameter "c" of the bladder captured in the longitudinal image frame, and assumes the measured values "b" and "c" of the anterior-posterior diameter and the superior-inferior diameter to be the maximum values of the bladder anterior-posterior diameter "b" and the superior-inferior diameter "c" in the series of longitudinal image frames captured during the imaging period of the imaging setting time "α" (i.e., times t1 to T1), and stores them in the memory unit 16 in association with the subject ID and the corresponding longitudinal image data (step Sa7).
[0111] Next, the image processor 193 increments the counter "N" by "1" (step Sa8) and determines whether the scan end timing has arrived (step Sa9). For example, when the imaging time setting is set to 2 seconds at a frame rate of 10 fps (frames per second), if the value of the counter "N" is "less than 20" in step Sa9, the image processor 193 determines "No" and returns the process to step Sa2. In the current case, since only the initial image frames of the transverse and longitudinal sections have been captured, the image processor 193 determines "No" in step Sa9 and returns the process to step Sa2.
[0112] Next, in order to capture the next transverse sectional image frame (second frame), the image processor 193 supplies the first probe 111 with a first input drive signal in cooperation with the signal processor 191 and the driver 13, and while capturing the next transverse sectional image frame, generates corresponding transverse sectional image data and stores it in the memory 16 (step Sa2). Then, the image processor 193 executes an image region extraction process based on the transverse sectional image data (step Sa3) and measures the lateral diameter "a" (step Sa3). At this time, the image processor 193 compares the measured value (measured for the second frame) with the lateral diameter "a" (measured for the first frame) already stored in the memory 16, and (i) if the measured value is greater than the previously stored value, overwrites and updates the lateral diameter "a" and transverse sectional image data stored in the memory 16 with the transverse image data and lateral diameter "a" corresponding to the currently captured transverse sectional image frame, and transitions to step Sa5. On the other hand, (ii) if the measured value of the transverse diameter "a" at this time is smaller than the transverse diameter already stored in the memory unit 16, the process proceeds to step Sa5 without overwriting the transverse image data and the transverse diameter "a". As a result, the memory unit 16 maintains the state in which (A1) the data of the transverse image frame in which the bladder is captured when the transverse diameter "a" is at its maximum, and (A2) the value of the transverse diameter "a" measured from this, linked to the subject ID and stored.
[0113] Next, the image processor 193, in cooperation with the signal processor 191 and the driver 13, supplies a second input drive signal to the second probe 112 to obtain longitudinal image data corresponding to the next longitudinal image frame (second frame) and store it in the memory 16 (step Sa5).The image processor 193 then performs an image region extraction process on the longitudinal image data, extracts an image region in which the bladder appears in the longitudinal image frame (step Sa6), and measures the anterior-posterior diameter "b" and the superior-subordinate diameter "c" of the bladder based on the image region (second frame). At this time, the image processing unit 193 compares the measurement value (measured for the second frame) with the measurement values of the anterior-posterior diameter "b" and the superior-subordinate diameter "c" already stored in the memory unit 16 (i.e., the measurement for the first frame), and (i) if the measurement value (measured for the second frame) is greater than the stored ones (first frame), the image processing unit 193 overwrites and updates the anteroposterior diameter "b" and superior-subordinate diameter "c" and the cross-sectional image data (i.e., corresponding to the first frame) already stored in the memory unit 16 with the longitudinal image data corresponding to the longitudinal image frame captured this time and the measurement values of the anteroposterior diameter "b" and superior-subordinate diameter "c" (step Sa7), increments the counter "N" by "1" (step Sa8), and then determines whether to end the scan (step Sa9). On the other hand, (ii) if the measured values of the anterior-posterior diameter "b" and the vertical diameter "c" at this time are smaller than the measured values of the anterior-posterior diameter "b" and the vertical diameter "c" already stored in the storage unit 16, the image processing unit 193 does not overwrite the longitudinal section image data and the measured values of the anterior-posterior diameter "b" and the vertical diameter "c" already stored in the storage unit 16, and shifts the process to step Sa8, increments the counter "N" by "1", and determines whether or not to end the scan (step Sa9). If the result of the determination in step Sa9 is "No", the image processing unit 193 returns the process to step Sa2 again and repeats the processes of steps Sa2 to Sa9. Thereafter, the processes of Sa2 to Sa9 are repeated, for example, 20 times, and when the value of the counter "N" reaches a value (for example, "20") corresponding to the imaging setting time "α" (i.e., when 20 image frames of each of the transverse section and the longitudinal section have been imaged), the process shifts to step Sa10.As a result of executing this series of processes, the memory unit 16 stores (A1) the cross-sectional image frame in which the bladder is most clearly visible among the cross-sectional and longitudinal image frame groups captured during the imaging set time "α", (A2) the measurement value of the left-right diameter "a" measured from the cross-sectional image frame, (B1) the longitudinal image frame in which the bladder is most clearly visible among the cross-sectional and longitudinal image frame groups captured during the imaging set time "α", and (A2) the measurement values of the anterior-posterior diameter "b" and the superior-subordinate diameter "c" measured from the longitudinal image frame, all linked to the subject ID.
[0114] When all data required for measuring the urine volume is thus stored in the memory unit 16, the image processor 193 substitutes the left-right diameter "a", the front-back diameter "b", and the top-bottom diameter "c" stored in the memory unit 16 into the above formula 1 to calculate the bladder volume (step Sa10), and stores the calculated value as a urine volume measurement value in the memory unit 16 while linking it to the subject ID (Sa11). At this time, the image processor 193 specifies the current date and time using a timer, generates measurement history data, and stores it in the memory unit 16, thereby building a database of the measurement history data on the memory unit 16.
[0115] Next, the image processor 193 simultaneously displays (A) the urine volume measurement results, (B) the cross-sectional image frame, (C) the longitudinal section image frame, and (D) the measurement results of the inner diameters "a", "b", and "c" stored in the memory unit 16 on the display unit 17 (step Sa12), and ends the urine volume measurement process. As a result, in the ultrasound diagnostic device 1, an image as shown in FIG. 14 is displayed on the display unit 17.
[0116] (3) Image region extraction processing Next, the image region extraction process executed by the image processing unit 193 in steps Sa3 and Sa6 of the urine volume measurement process will be described with reference to Fig. 15. Fig. 15 is a flowchart showing the image region extraction process executed by the image processing unit 193 of this embodiment. In the following, it is assumed that data corresponding to the transverse sectional image frames or longitudinal sectional image frames acquired in steps Sa2 and Sa5 have already been stored in the storage unit 16.
[0117] In this state, the image processing unit 193 first performs edge detection processing on the data of each cross section stored in the memory unit 16 (step Sc1), and binarizes the transverse cross-sectional image or the longitudinal cross-sectional image based on the data after edge detection (step Sc2).
[0118] Next, the image processor 193 performs noise removal on the binarized data of each image frame (step Sc3), performs edge linkage (step Sc4), thins the image (step Sc5), traces the boundary of the bladder reflected in the image (step Sc5), and extracts the image area in which the bladder is reflected from each cross-sectional image based on the image after the tracing (step Sc6), and ends the process. At this time, the image processor 193 compares the image after the tracing with the extraction condition data stored in advance in the storage unit 16, and if the image after the tracing resembles the bladder shape model included in the extraction condition data and the brightness within the boundary is low, it is determined that the image area is the image area in which the bladder is reflected.
[0119] As described above, the ultrasonic diagnostic device 1 of this embodiment uses the above-configured probe unit 11, and can easily, quickly, and appropriately capture each image frame of the transverse section and the longitudinal section of the bladder at approximately the same time and simultaneously display them so that the operator can view them, thereby dramatically facilitating the procedure during bladder observation and improving the observation accuracy. In addition, the ultrasonic diagnostic device 1 of this embodiment can capture each appropriate image frame of the transverse section and the longitudinal section with only a very simple operation, and can realize accurate measurement of the urine volume based on the image. Furthermore, the ultrasonic diagnostic device 1 of this embodiment performs urine volume measurement based on each ultrasonic diagnostic image frame of the transverse section and the longitudinal section in which the bladder is most prominent among the image frames captured during a predetermined imaging setting time "α" during urine volume measurement, thereby reducing the influence of the operator's proficiency in the procedure on the measurement result and reducing the occurrence of personal errors due to experience. As a result, not only operators who are skilled in operating ultrasonic diagnostic devices, but also operators who are unfamiliar with operating ultrasonic diagnostic devices can easily, conveniently, and quickly measure the urine volume in the bladder while preventing the occurrence of errors. Furthermore, since the probe unit 11 of this embodiment does not require the use of a motor or the like, the occurrence of breakdowns can be suppressed.
[0120] In this embodiment, the display unit 17 is installed on the upper part of the housing 12, but an external display may be connected to the communication unit 18 to display an image as shown in FIG. 14 on the display. In the above embodiment, a method of counting the number of imaging hours by setting a counter "N" in the urine volume measurement process is adopted, but a method of counting the number of imaging hours by using a timer may be adopted. Furthermore, in this embodiment, an example is described in which the bladder volume (urine volume) is measured as a size parameter from the measurement results of each inner diameter of the bladder, but the measurement target may be the cross-sectional area of the bladder, and in this case, an appropriate area calculation formula may be used instead of Formula 1. In this embodiment, the bladder is the subject S, but other tissues around the bladder may be observed or may be measured as the size parameter. In this case, the first and second cross sections may be short-axis cross sections and long-axis cross sections in addition to transverse and longitudinal cross sections. Furthermore, in this embodiment, the configuration is adopted in which the images of the transverse section and the longitudinal section, which are captured almost simultaneously in the observation mode, are simultaneously displayed in almost real time, but a configuration may be adopted in which only one of the transverse section and the longitudinal section is displayed. In this case, a configuration may be adopted in which only one of the two probes 111 and 112 is used to capture corresponding cross-sectional images and sequentially display them on the display unit 17.
[0121] [B] Variation [B1] Variation 1 In the above embodiment, as shown in Figs. 2, 6 and 8(C), the second probe 112 is configured as a micro-convex probe having a curvature of about "14 (mm)" and an angle of view of about "70° to 110°", but the second probe 112 may be configured to use a micro-convex probe with one side missing as shown in Fig. 16. Fig. 16 shows the relationship between the installation angles and installation positions of both probes 111 and 112-A and the irradiation directions of the first and second sound beams SB1 and SB2 in a side view of the probe unit 11 constituting the ultrasonic diagnostic device 1A of this modification as seen from the same direction as Fig. 6 (i.e., the direction of "B" in Fig. 2(B)). As in Fig. 6, the tail side of the subject's body in a state where the above-mentioned contact conditions (1) to (3) are satisfied and the head side is the left side of the drawing. In Fig. 16, the same components as those in the above embodiment are denoted by the same reference numerals. Furthermore, as described below, in this modified example, the second probe 112-A is installed perpendicular to the direction parallel to the installation surface 12A (i.e., parallel to the normal direction ND), so that when viewed from the same direction as in Fig. 2(A), the second probe 112-A is not installed at an angle but is installed vertically, but this point is not related to the gist of this modified example and is not shown in the figure.
[0122] As shown in Fig. 16, in this modification, the second probe 112-A has a configuration in which a part of the micro-convex probe is missing. With this configuration, the second probe 112-A of this modification does not need to be inclined as in the above embodiment, but is installed perpendicular to the direction parallel to the installation surface 12A (i.e., parallel to the normal direction ND), and the angle "θ2" between the direction that is the start point or end point of the transmission range of the second sound beam SB2 and the normal direction ND can be set to about "+30°", and the transmission range can be set to about "95°" of about "+30° to -65°". Note that in this modification, the first probe 111 has the same configuration as in the above embodiment, so details will be omitted. As a result, according to this modification, the size constraints imposed when configuring the probe unit 11 are reduced, making it possible to miniaturize the probe unit 11 and the ultrasonic diagnostic apparatus 1, and it is also not necessary to devise wiring or a driving method as in the above-mentioned implementation method 2, thereby preventing the apparatus from becoming complicated and realizing a reduction in the cost of the probe unit 11 and the ultrasonic diagnostic apparatus 1. Note that other configurations, operations during observation of the subject S and urine volume measurement, and operation of the apparatus are the same as those of the above-mentioned embodiment.
[0123] [B2] Variation 2 Next, a second modified example of the present invention will be described with reference to Fig. 17. Fig. 17 is a diagram showing the relationship between (a) the installation angle and installation position of both probes 111-B and 112-B, (b) the height of both probes 111-B and 112-B, and (c) the irradiation direction of the first and second sound beams SB1 and SB2, in a side view of the probe unit 11 constituting the ultrasonic diagnostic device 1B of this modified example seen from the same direction as Fig. 6 (i.e., the direction of "B" in Fig. 2(B)). As in Fig. 6, the tail side of the subject's body in a state where the probe unit 11 is abutted against the front side of the subject's body surface while satisfying the above-mentioned abutment conditions (1) to (3) as in Fig. 7 is shown on the right side of the drawing, and the head side is shown on the left side of the drawing. Also, in Fig. 17, the same reference numerals are given to the same components as those in the above-mentioned embodiment.
[0124] As shown in Fig. 17, in this modification, the heights of the first probe 111-B and the second probe 112-B are adjusted to prevent the first sound beam SB1 and the second sound beam SB2 from being reflected by the other probes 111-B and 112-B, respectively, and a method is adopted in which the separation distance "l" between the two probes 111-B and 112-B is set to a value of approximately "0", such as "0.1 mm or less". According to this modification, it is possible to miniaturize the ultrasonic diagnostic device 1 and the probe unit 11. Note that the specific setting values of the angles "θ1 to θ3", other configurations, operations during observation of the subject S and urine volume measurement, and operation of the device are the same as those of the above embodiment, and therefore details will be omitted.
[0125] [B3] Variation 3 In the above embodiment and each modified example, a rectangular parallelepiped housing 12 is used, and the installation surface 12A is not inclined, and when the probe unit 11 is brought into contact with the installation surface 12A while satisfying the above-mentioned contact conditions (1) to (3), the installation surface 12A itself is made to have a planar shape that is maintained parallel or approximately parallel to the virtual tangent or tangent plane VT of the subject's body surface in an undeformed state. However, the installation surface 12A is not limited to this type of planar shape that is completely free of inclination, and may have a planar portion that is partially free of inclination and that is maintained parallel or approximately parallel to the virtual tangent or tangent plane VT of the subject's body surface in an undeformed state when the probe unit 11 is brought into contact with the installation surface 12A while satisfying the above-mentioned contact conditions (1) to (3). For example, (1) a shape having planar portions corresponding to the four corners and other portions being curved or inclined, or (2) a shape in which only a portion of the installation surface 12A, such as the center portion, is the corresponding planar portion, and other portions are curved or inclined, may be adopted. In this case, a configuration is adopted in which a virtual plane in which the corresponding planar portion provided on the installation surface 12A is expanded over the entire installation surface 12A or a virtual plane connecting the planar portions is defined, and this virtual plane is regarded as equivalent to the installation surface 12A in the above embodiment, and the first probe 111 is installed on the installation surface so that the reference line segment RLS of the transducer array 111C of the first probe 111 is parallel to this virtual plane. Also, in this case, as shown in Fig. 7, (1) the first scanning direction SD1 is maintained approximately parallel to the transverse section of the subject's body part, (2) the second scanning direction SD2 is aligned with the median line of the subject's body part, and (3) the virtual plane in abutment state in which the virtual plane is parallel or approximately parallel to the virtual tangent line or tangent plane VT of the body surface in an undeformed state is set as a reference plane (i.e., a plane equivalent to the planar installation surface 12A in the above embodiment and each modified example). That is, in this modified example, this imaginary plane constitutes the "reference plane" of the present invention, and the normal direction of this imaginary plane (corresponding to the normal direction ND in FIG. 6) becomes the reference for the first to third angles.
[0126] Then, a method may be adopted in which the first and second probes 111 and 112 are installed while defining the angles "θ1 to θ3" based on the normal direction of the reference plane. In this case, it is desirable to adopt a method in which a line indicating the position or direction of the virtual plane is printed or engraved on the side surface of the housing 12, and the operator uses this line as a reference to abut the line so that it is parallel or approximately parallel to a virtual tangent or tangent plane VT of the subject's body surface in an undeformed state.
[0127] In this case, the method of setting the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction of the virtual plane, the specific method of setting the transmission angle range of the second sound beam SB2 (i.e., the angle range defined by angles "θ2 and θ3"), and the installation method of the first and second probes 111 and 112 are the same as those of the above-mentioned embodiments and each modified example, and the virtual plane is regarded as being equivalent to the installation surface 12A, and both probes 111 and 112 are installed so that the angle "θ1" is approximately "-30° to -60°" (preferably approximately "-45°"), "θ2" is approximately "-65° to -80°", and angle "θ3" is approximately "+5° to +30°" based on the normal direction of the virtual plane, or a configuration is adopted in which the transducer array 111C of the second probe 112 is driven so that the second sound beam SB2 is irradiated within that angle range. At this time, it is desirable to set the angles "θ1 to θ3" to desired angles by placing a housing (not shown) on a platform that is kept horizontal so that the virtual plane becomes a horizontal plane. Other configurations, operations during observation of the subject S and urine volume measurement, and operation of the device are similar to those of the above embodiment, so details will be omitted.
[0128] [B4] Variation 4 Next, the fourth modification of the present invention will be described with reference to Figs. 18 and 19. Fig. 18 is a diagram showing a configuration example of an ultrasonic diagnostic device 1C of this modification, in which (A) shows an external configuration example of the ultrasonic diagnostic device 1C, and (B) shows the configuration of the probe unit 110 provided inside the housing 120 of the ultrasonic diagnostic device 1C, assuming that it has the same configuration as the above embodiment. Fig. 19 is a cross-sectional view of the ultrasonic diagnostic device 1C of this modification seen from the "D direction" of Fig. 18(A), and like Fig. 6, the tail side of the subject's body is shown on the right side of the drawing, and the head side is shown on the left side of the drawing, in a state where (1) the first scanning direction SD1 is maintained parallel or approximately parallel to the transverse section of the subject's body, (2) the second scanning direction SD2 is made to run along the median line of the subject's body, and (3) a virtual reference plane VRP described later is brought into contact with a virtual tangent or tangent plane VT of the body surface in an undeformed state, as shown in Fig. 7. In addition, in Fig. 18, the same components as those in the above embodiment are denoted by the same reference numerals. Note that in this modified example, the shape of the housing is changed from that of the above embodiment, so that in the contact state shown in Fig. 7, the shape of the housing in (A) changes from a rectangle to an ellipse, and the shapes of the housings in (B), (C), and (D) also change to an ellipse, but otherwise it is the same as Fig. 7.
[0129] In the above embodiment and each modification, a rectangular parallelepiped housing 12 is used, and the installation surface 12A is flat. In contrast, an ultrasonic diagnostic device 1C of this modification uses an ellipsoid housing 120 as shown in FIG. 18(A). The housing 120 has a hollow structure as shown in FIG. 19. A display unit 170 is provided on a protrusion 120-1 provided on the upper surface side of the housing 120, and an installation surface 120A for installing the first and second probes 111-C and 112-C is provided inside the housing 120. The first and second probes 111-C and 112-C are installed on the installation surface 120A toward the bottom surface side of the housing 120. Inside the housing 120, a material that does not easily attenuate sound waves, such as gel or oil, is filled in the space between the acoustic lens 111E of both probes 111-C and 112-C and the inner surface of the housing 120 to form a gel or oil layer 11B-1, and the bottom surface of the housing 120, the gel or oil layer 11B-1, and both probes 111-C and 112-C constitute the probe section 110. Note that, while Figs. 18(A) and 19 show an example in which the housing 120 and the body surface contact case are integrated, it is also possible to separate the two as shown in Fig. 18(B), provide a mounting surface 120A on the bottom surface of the housing 120, and cover the mounting surface 120A with a body surface contact case having a semi-ellipsoid shape or the like and adhere it to the housing 120, resulting in a configuration as shown in Fig. 18(A).
[0130] Here, as shown in FIG. 19, in this modification, the installation surface 120A is entirely formed of inclined or curved surfaces, and does not have a flat surface without inclination. When this configuration is adopted, it is difficult to define the normal direction ND that is the reference of the angles "θ1 to θ3" as it is. For this reason, in the ultrasonic diagnostic device 1C of this modification, when the probe unit 110 is abutted against the subject's body surface in the housing 120, a virtual reference plane VRP, which is a virtual plane, is set at a position facing the body surface. Then, a method is adopted in which the first probe 111 is installed so that the virtual reference plane VRP and the reference line segment RLS of the transducer array 111C of the first probe 111 are parallel to each other.
[0131] With this configuration, (a) the virtual tangent or tangent plane VT of the body surface in an undeformed state is parallel or approximately parallel as viewed from the virtual reference plane VRP, and (b) while maintaining the virtual reference plane VRP parallel or approximately parallel as viewed from the virtual tangent or tangent plane VT of the body surface in an undeformed state, when the probe unit 110 at the bottom of the housing 120 is abutted as shown in Fig. 7(A) (i.e., the abutment state that satisfies the above-mentioned abutment conditions (1) to (3)), the normal direction ND of the virtual reference plane VRP coincides with the normal direction ND of the installation surface 12A in the above-mentioned embodiment that defines the angles "θ1 to θ3". For this reason, in this modified example, a method is adopted in which the angles "θ1 to θ3" are set based on the normal direction ND of the virtual reference plane VRP.
[0132] Also in this modified example, as in FIG. 7, (1) the first scanning direction SD1 is maintained approximately parallel to the transverse plane so that the first probe 111-C is located closer to the cranial side than the second probe 112-C (corresponding to the above-mentioned contact condition (1)), (2) the second scanning direction SD2 is aligned with the midline (corresponding to the above-mentioned contact condition (2)), and (3) the virtual reference plane VRP is maintained parallel or approximately parallel to the virtual tangent or tangent plane VT of the body surface in an undeformed state (corresponding to the above-mentioned contact condition (3)). In this contact state, the first probe 111-C is placed on the cranial side of the subject's body as viewed from the second probe 112-C, and the second probe 112-C is placed at a position approximately 3 mm caudal to the first probe 111-C as viewed from the first probe 111-C. However, in this modification, the shape of the housing 120 is changed from that of the above embodiment, so that the abutting state shown in FIG. 7 is the same as that in FIG. 7 except that the housing shape in (A) is changed from a rectangle to an ellipse, and the housing shapes in (B), (C), and (D) are also changed to an ellipse. Furthermore, in this modification, the transducer array 111C of the first probe 111-C is also arranged along the first scanning direction SD1. On the other hand, the transducer array 111C of the second probe 112-C is arranged along the second scanning direction SD2 perpendicular to the arrangement direction of the transducer array 111C of the first probe 111, with the center in the arrangement direction (longitudinal direction) of the transducer array 111C of the first probe 111-C as the starting point or ending point, and the transducer arrays 111C corresponding to both probes 111-C and 112-C are arranged in an approximately T-shape (see FIG. 18(B)). As a result, in this modified example as well, as in the above-described embodiment and each modified example, by performing electronic scanning in the first and second scanning directions SD1 and SD2, first and second sound beams SB1 and SB2 that are perpendicular to each other are transmitted.
[0133] In this modification, the first probe 111-C is installed at an inclination of, for example, 45° caudal around the first rotation axis AR1 as viewed from the normal direction ND of the virtual reference plane VRP so that, when electronically scanned in the first scanning direction SD1 in the above-mentioned contact state, the first sound beam SB1 inclined at "θ1" (for example, "-45°") caudal as viewed from the normal direction ND of the virtual reference plane VRP is irradiated. As a result, the first sound beam SB1 is irradiated in the dorsal-caudal direction from the contact position in a state inclined at, for example, 45° as viewed from the virtual tangent or tangent plane VT of the body surface in an undeformed state. Note that the irradiation state of each sound beam SB1 and SB2 on the subject's body part and the positional relationship of the subject S at this time are the same as those in FIGS. 7B, 7C, and 7D, except that the shape of the housing 120 is elliptical. The specific value of the angle "θ1" is the same as in the embodiment, and can be freely set within the range of about "-30° to -60°", but it is preferable to set it to "θ1 = -45°" in accordance with the standard body. This point is the same as in the above embodiment.
[0134] On the other hand, the second probe 112-C is installed so that the transmission angle range of "θ2" is approximately "-65° to -80°" and the angle "θ3" is approximately "+5° to +30°", or the transducer array 111C is driven so that the second sound beam SB2 is irradiated in that angle range. In addition, the specific method for setting the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND of the virtual reference plane VRP and the transmission angle range of the second sound beam SB2 defined by the angles "θ2 and θ3" are arbitrary, and for example, the ellipsoid-shaped housing 120 may be placed on a table kept horizontal, and while keeping the virtual reference plane VRP horizontal, the first probe 111-C and the second probe 112-C may be placed on the installation surface 120A, and the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND and "θ2 and θ3" which define the transmission angle range of the second sound beam SB2 may be adjusted to the desired angles.
[0135] When actually observing a subject S or measuring a urine volume using the ultrasonic diagnostic apparatus 1C of this modification, as in FIG. 7, (1) the first probe 111-C is located about 5 to 6 cm above the suprapubic region relative to the second probe 112-C while maintaining the first scanning direction SD1 parallel or approximately parallel to the transverse plane (corresponding to the above-mentioned abutment condition (1)), (2) the second scanning direction SD2 is aligned with the median line (corresponding to the above-mentioned abutment condition (2)), and (3) the virtual reference plane VRP is aligned with a virtual tangent or tangent plane of the undeformed body surface. 12 to 15, drive signals are supplied alternately to the first probe 111-C and the second probe 112-C for one frame at a time to capture images of the transverse and longitudinal sections alternately for one frame at a time, and (a) these are displayed simultaneously on the display unit 170, or (b) a urine volume measurement is performed, and (b1) the measurement result of the urine volume and (b2) the images of the transverse and longitudinal sections used in the measurement are displayed simultaneously on the display unit 170. Other points and the method of adjusting the contact angle during observation are the same as those in the above embodiment (see FIG. 7). However, in this modified example, since the reference of the normal direction ND is the virtual reference plane VRP, it is preferable to adopt a method in which (A) a line L indicating the virtual reference plane VRP is engraved or printed on the side of the housing 120 as exemplified in Fig. 18(A) and the operator abuts the virtual reference plane VRP so that the virtual tangent or tangent plane VT of the body surface in an undeformed state is parallel or approximately parallel to the virtual tangent or tangent plane VT of the body surface in an undeformed state and the virtual reference plane VRP are parallel to each other. In addition, in the configuration of this modified example, in order to enable the operator to intuitively grasp which side of the device should be the tail side and which side should be the head side, it is preferable to (i) clearly indicate the direction when abutting the side of the housing 120 by engraving or printing on the housing 120, or (ii) display the positions and directions of the first and second scanning directions SD1 and SD2 on the display unit 170 prior to observation and measurement, thereby presenting the operator with the abutment method.
[0136] The configuration of this modification allows the use of housings 120 of various shapes, and the shape of the installation surface 120A can be configured entirely of curved or inclined surfaces, improving the degree of freedom in device design. In this modification, an ellipsoidal housing 120 is used, and the installation surface 120A of the shape illustrated in FIG. 19 is provided inside the housing 120 or on the bottom surface of the housing 120. However, the specific shapes of the housing 120 and the installation surface 120A are arbitrary, and a spherical housing 120 or a housing 120 of other polyhedral shapes can be used. In addition, any shape may be used for the installation surface 120A as long as it does not have a flat surface.
[0137] [B5] Variation 5 In the above embodiment, as shown in Fig. 5(A) etc., a material that does not easily attenuate sound waves, such as gel or oil, is filled between the acoustic lenses 111E of both probes 111 and 112 and the body-surface-contacting case 11A to form a gel or oil layer 11B. On the other hand, since the body-surface-contacting case 11A only needs to maintain its spherical shape, the material thereof may be an elastic body or a hard plastic such as modified PP, or the embodiments shown in Figs. 20(A) to (E) may be adopted.
[0138] For example, (Pattern 1) as shown in Figure 20(A), a first cover 11A-1 is made of elastic or hard resin, etc., and the inner area (shaded area in Figure 20(A)) of the body surface-contacting case 11A is filled with insulating oil, or a second resin made of a material with an acoustic impedance similar to that of biological tissue, such as gel, rubber material, polyurethane, etc., and a mode can be adopted in which gel is applied to the surface of the body surface-contacting case 11A during actual observation of the subject S and measurement of urine volume.
[0139] (Pattern 2) Also, as shown in FIG. 20(B), a body-surface-contacting case 11A having a first cover 11A-1 made of elastic or hard resin or the like, and only the area close to the lens surface of the acoustic lens 111E (i.e., the area with a thin dotted pattern in FIG. 20(B)) filled with a material with an acoustic impedance similar to that of biological tissue, such as gel, rubber, polyurethane, etc., and the other area (the area with diagonal lines in FIG. 20(B)) left hollow, can be used in such a way that gel can be applied to the surface of the body-surface-contacting case 11A when actually observing the subject S or measuring the amount of urine.
[0140] (Pattern 3) Furthermore, as shown in FIG. 20(C), a first cover 11A-1 that covers only a part of the probe portion 11 can be formed from an elastic or hard resin or the like, and a case made of a resin (e.g., a material with an acoustic impedance similar to that of biological tissue, such as rubber or polyurethane, that can replace gel when in use) molded into the shape of an area close to the lens surface of the acoustic lens 111E (i.e., the area with a dark dot pattern in FIG. 20(C)) can be used to cover the acoustic lens 111E. In this way, the body surface-contacting case 11A itself can be used as a substitute for gel, so that an ultrasonic diagnostic image of the subject S can be captured without applying gel to the surface when in use, and the image can be used for diagnosis as well as for measuring size parameters.
[0141] 20(D), the inside of the body-surface-contact case 11A itself may be made of a material having an acoustic impedance similar to that of living tissue, such as rubber or polyurethane, which is molded into a shape that fills the steps of the first probe 111 and the second probe 112 and which serves as a substitute for gel when in use, and the body-surface-contact case 11A may be attached to cover an area close to the lens surface of the acoustic lens 111E (i.e., an area with a dark dot pattern in FIG. 20(D)) when observing the subject S and measuring the amount of urine. This allows the body-surface-contact case 11A itself to be used as a substitute for gel, so that an ultrasonic diagnostic image of the subject S can be captured without applying gel to the surface when in use, and the image can be used for diagnosis as well as for measuring size parameters.
[0142] (Pattern 5) Furthermore, as shown in FIG. 20(E), the inside of the body surface contact case 11A itself is made of a material with an acoustic impedance similar to that of living tissue, such as a rubber material or polyurethane molded in a shape that fills the step between the first probe 111 and the second probe 112, and the body surface contact case 11A is attached to cover the lens surface of the acoustic lens 111E as shown in the dark dot pattern area in FIG. 20(E) when observing the subject S and measuring the urine volume, and various other modes can be adopted. With this configuration, for example, by adopting patterns 3 and 4, the application of gel during use can be omitted to reduce the operator's work, and the subject's body surface is not soiled, so that the examination burden on the subject can be reduced. In addition, various configurations can be used to realize functions similar to those of the above-mentioned embodiments.
[0143] [B6] Variation 6 Next, a sixth modified example of the present invention will be described with reference to Figures 21 and 22. Figure 21 is a diagram showing the relationship between the installation angles and installation positions of both probes 111-D and 112-D and the irradiation directions of the first and second sound beams SB1 and SB2 in a side view of the probe unit 11 constituting the ultrasonic diagnostic device 1D of this modified example seen from the same direction as in Figure 6 (i.e., the direction of "B" in Figure 2(B)), and Figure 22 is a diagram showing a method of contacting the ultrasonic diagnostic device 1D of this modified example when observing the tissue around the bladder and measuring the urine volume using the ultrasonic diagnostic device 1D. 21, the abutment state shown in FIG. 22 (specifically, (1) a first scanning direction SD1 coinciding with a reference line segment RLS connecting the center points of both ends of the transducer array 111C of the first probe 111 is maintained parallel or approximately parallel to the transverse plane so that the first probe 111 is located on the caudal side of the subject's body relative to the second probe 112 (corresponding to the above-mentioned abutment condition (1)), (2) a second scanning direction SD2 coinciding with a line segment connecting the center points of both ends of the second probe 112 is aligned along the median line (corresponding to the above-mentioned abutment condition (2)), and (3) the installation While keeping the surface 12A parallel or approximately parallel to the imaginary tangent or tangential plane VT of the body surface in an undeformed state (corresponding to the above-mentioned abutment condition (3)), the ultrasound diagnostic device 1D is abutted symmetrically with respect to the midline so that the first probe 111-D is located at a predetermined position (specifically, a position about 5 to 6 cm above) the pubic bone (head side) of the subject (see Fig. 7(B) and Fig. 22), the caudal direction of the subject's body is the right side of the drawing, and the head direction is the left side of the drawing. Furthermore, in Fig. 21, the same reference numerals are used for the same components as those in the above-mentioned embodiment.
[0144] Here, in the above embodiment, as described above, the second probe 112 is configured as a micro-convex probe with a curvature of about "14 (mm)" and an angle of view of about "70° to 110°", and the description has been given of an example in which both probes 111 and 112 are placed on the placement surface 12A so that (A) the first probe 111 is located on the head side of the subject's body and (B) the second probe 112 is located on the tail side of the subject's body in an abutment state (see FIG. 7) that satisfies the above abutment conditions (1) to (3) (see FIG. 6). In contrast, in the ultrasound diagnostic device 1D of this modification, a micro-convex probe having a shape cut in approximately half is adopted as the second probe 112-D, as exemplified in FIG. 21.
[0145] In this modified example, as shown in FIG. 21, in the above-mentioned abutment state (see FIG. 22), a configuration is adopted in which both probes 111-D and 112-D are placed on the placement surface 12A so that (A) the first probe 111-D is located at the caudal side of the subject's body and (B) the second probe 112-D is located at the cranial side of the subject's body.
[0146] In this modification, the first probe 111-D is installed at an angle "θ1" in the direction opposite to the side where the second probe 112-D is installed (i.e., the tail side of the subject's body) as viewed from the normal direction ND of the installation surface 12A, with the first rotation axis AR1 as the center. With this configuration, the first sound beam SB1 is irradiated onto the subject's body surface in a state inclined at an angle "θ1" toward the tail side of the subject's body as viewed from the normal direction ND. Note that the specific value of the angle "θ1" is the same as in the above embodiment and can be freely set within the range of "-30° to -60°", but in this modification, it is preferable to set "θ1 = -45°" to suit a subject of standard build, as in the above embodiment.
[0147] With this configuration, similar to the above embodiment, by simply adjusting the contact angle to approximately "15° to 40°", it is possible to appropriately irradiate the first acoustic beam SB1 onto the entire cross section of the center of the bladder while avoiding the pubic bone for subjects of any body type, thereby appropriately capturing a cross-sectional image of the bladder.
[0148] On the other hand, in the ultrasonic diagnostic device 1D of this modification, the positional relationship between the first probe 111-D and the second probe 112-D is replaced from the positional relationship in the above embodiment and each modification, so that it is necessary to install the second probe 112-D farther from the installation surface 12A than the first probe 111-D as shown in FIG. 21. When adopting a configuration in which the second probe 112-D is farther from the installation surface 12A than the first probe 111-D in this way, the overlapping manner of the irradiation ranges of the first and second sound beams SB1 and SB2 changes. Therefore, even if the angle "θ1" is set to "-45°", the angle "θ2" is set to "-65°", the angle "θ3" is set to "+30°", and the transmission angle range of the second sound beam SB2 is set to a total of "95°" from "+30° to -65°" as in the above embodiment and modification, the crossing range of the first sound beam SB1 and the second sound beam SB2 becomes narrow. As a result, even if the ultrasonic diagnostic device 1D is brought into contact with the subject S such that the installation surface 12A is parallel or approximately parallel to the virtual tangent or tangential plane VT of the body surface in an undeformed state in the contact state shown in Fig. 22, the possibility that the transverse and longitudinal sections of the subject S cannot be properly depicted cannot be eliminated. Therefore, in the ultrasonic diagnostic device 1D of this modification, the condition of the transmission angle range of the second sound beam SB2 is changed from that of the above embodiment and each modification, the transmission angle range of the second sound beam SB2 is set to "95°" from "+5° to -90°", the overlapping range of the first sound beam SB1 and the second sound beam SB2 is widened, and the first sound beam SB1 and the second sound beam SB2 are irradiated to the subject S while sufficiently intersecting with each other. With this configuration, even when the ultrasound diagnostic apparatus 1D of this modified example has the configuration as shown in FIG. 21, it is possible to appropriately capture an overall image of the transverse and longitudinal cross sections of the bladder of the subject S regardless of the body type of the subject, simply by contacting the ultrasound diagnostic apparatus 1D with the body surface as shown in FIG. 22 and adjusting the contact angle to about "15° to 40°."
[0149] However, in the case of this modified example, in order to satisfy the above-mentioned abutment conditions (1) and (2), it is necessary to change the abutment position and orientation when the ultrasonic diagnostic device 1D is abutted against the front (ventral side) of the subject's body from the position and orientation shown in Fig. 7(A) to the position and orientation shown in Fig. 22. Specifically, as shown in Fig. 22, the first probe 111-D is placed at a position about 5 to 6 cm above the pubic bone while the first scanning direction SD1 is kept parallel or approximately parallel to the transverse plane, and the second probe 112-D is placed along the median line of the subject's body so that the second probe 112-D is abutted against the body surface so that it is located closer to the head than the first probe 111-D, thereby satisfying the abutment conditions (1) and (2). At this time, the ultrasonic diagnostic device 1D is abutted against the body surface so that the installation surface 12A is parallel or approximately parallel to the virtual tangent line or tangent plane VT of the undeformed body surface, thereby satisfying the abutment condition (3). Other configurations, operating methods when observing the subject S and measuring urine volume, and operation of the device are the same as those of the above embodiment, except that the transmission angle range of the second sound beam SB2 is "+5° to -90°" and the second sound beam SB2 is irradiated to the subject S within this angle range from the head side of the subject, so details will be omitted.
[0150] This configuration improves the degree of freedom in the arrangement of both probes 111 and 112 (111-D and 112-D in FIG. 21), and improves the degree of freedom in designing the device. In FIG. 21, the rectangular parallelepiped housing 12 is used as in the above embodiment, and the installation surface 12A has a planar structure. However, the shapes of the housing and the installation surface 12A are not limited to this, and an installation surface structure other than a flat surface without inclination may be adopted as in Modifications 3 and 4, and the housing shape may be an ellipsoid or the like. In either case, the positional relationship of the first probe 111-D and the second probe 112-D with respect to the installation surface 12A or the installation surface 120A may be exchanged, the angle "θ1" may be set to "-30° to -60°" (preferably "-45°"), and the transmission angle range of the second sound beam SB2 may be set to "+5° to -90°". In this case, as in the third and fourth modified examples, it is desirable to print or engrave a line indicating the virtual reference plane VRP, etc. (for example, a line similar to line L, etc. in FIG. 18(A)) on the side of the housing 120 so that the virtual reference plane VRP, etc. and the virtual or tangential plane VT of the body surface in an undeformed state can be abutted parallel or approximately parallel to each other.
[0151] [B7] Variation 7 In the above embodiment, an example has been described in which the first probe 111 is a convex type probe and the second probe 112 is a micro-convex type probe. However, by adopting a configuration in which both probes 111 and 112 have a trapezoidal (trapezoidal) scan capability and transmit and receive sound beams in a relatively low frequency band of about 2 to 3 MHz, the first probe 111 can be configured as a linear type probe and the second probe 112 can be configured as a small linear type or sector type probe. In this case, the installation angle "θ1" when installing the first probe 111 is set to, for example, "-45°", the inclination angle "θ1" of the first sound beam SB1 with respect to the normal direction ND is set to "-45°", and the angles "θ2 and θ3" between the starting point or ending point direction of the second sound beam SB2 and the normal direction ND are set to "-65° to -80°" and "+5 to +30°", respectively, so that the subject S can be observed or the urine volume can be measured by capturing images of the transverse and longitudinal sections similar to those in the above embodiment. With this configuration, the configuration of the probe unit 11 can be simplified and the ultrasonic diagnostic device 1 can be manufactured at a low cost.
[0152] [B8] Variation 8 In the above embodiment, the control unit 19 of the ultrasound diagnostic apparatus 1 executes processing such as urine volume measurement, but the ultrasound diagnostic apparatus 1 may be configured as an ultrasound diagnostic image processing probe apparatus with the display unit 17 omitted, and ultrasound diagnostic image data generated by the ultrasound diagnostic image processing probe apparatus may be transmitted to an external display device such as a tablet-type information and communication terminal device, a smartphone, a laptop PC (personal computer), or a PC monitor, and processing for simultaneous display may be executed on the display device side, or the display device may execute processing for urine volume measurement and image region extraction while measuring the urine volume and simultaneously displaying the results.
[0153] [B9] Variation 9 In the above embodiment and modified example, the normal direction ND is defined based on the installation surface as a reference plane or a virtual reference plane that is maintained parallel or approximately parallel to the virtual or tangential plane VT of the body surface in an undeformed state when in contact, but when the body surface contact case 11A is provided, the normal direction may be defined based on the contact surface where the body surface contact case 11A contacts the body surface. Also, when the body surface contact case 11A is not provided, the first and second probes 111 and 112 directly contact the body surface. In this case, a method of defining the normal direction based on the contact surface where the first and second probes 111 and 112 contact the body surface may be adopted. [Explanation of symbols]
[0154] 1, 1A, 1B, 1C, 1D...Ultrasound diagnostic equipment 11, 110…Probe section 11A…Body-tight case 11B, 11B-1...Gel or oil layer 111, 111-A, 111-B, 111-C, 111-D...First probe 111A…Vibrator stand 111B…Backing material 111C... Transducer array 111D…matching layer 111E…acoustic lens 112, 112-A, 112-B, 112-C, 112-D...Second probe 12, 120…Housing 12A, 120A…Installation surface 13...Drive unit 14…Receiver 15...Operation unit 16...Storage section 17, 170...Display section 18…Communications Department 19...Control section 191...signal processing unit 192…Control Department 193...Image processing unit 2...External device SB1…First sound beam SB1': Irradiation direction of the first sound beam that captures the maximum cross section of the bladder SB2: Second sound beam SD1: First scanning direction SD2: Second scanning direction AR1: First rotation axis AR2: Second rotation axis RLS: Reference line segment VT: Virtual tangent or tangent plane of the undeformed body surface VRP: Virtual Reference Plane L…Line ND, ND'…Normal direction
Claims
1. 1. An ultrasonic diagnostic image processing probe device that is used in a state where it is in contact with a body surface on a front side of a subject's body part in parallel or approximately parallel to the body surface, and generates ultrasonic diagnostic image data by capturing an image of a subject inside the subject's body, a first sound wave transmitting / receiving means provided in the ultrasonic diagnostic image processing probe device, the first sound wave transmitting / receiving means being configured with a first transducer array arranged along a first direction parallel to a reference plane that is positioned opposite to a body surface of the subject during imaging, the first sound wave beam being projected onto the subject, and an electrical signal being output as a first output signal; a second acoustic wave transmitting / receiving means configured with a second transducer array arranged along a second direction perpendicular to the first direction and arranged in a substantially T-shape with the first transducer array, the second acoustic wave beam being perpendicular to the first acoustic beam and projected onto the subject within a predetermined transmission angle range, and outputting an electrical signal obtained as a second output signal; (A1) a driving means for transmitting the first sound beam from the first sound wave transmitting / receiving means, and (A2) a driving means for transmitting the second sound beam from the second sound wave transmitting / receiving means; a generating means for (1) maintaining the first direction parallel or approximately parallel to a cross section of the subject's body part, (2) aligning the second direction along the midline of the subject's body part, and (3) bringing the reference plane into contact with a predetermined position of the subject's suprapubic bone while aligning it with the body surface on the front side of the subject's body part, (B1) electronically scanning the subject in the first direction with the first sound beam to generate first ultrasonic diagnostic image data of the subject in the first direction, and (B2) electronically scanning the subject in the second direction with the second sound beam to generate second ultrasonic diagnostic image data of the subject in the second direction, and storing the second ultrasonic diagnostic image data in a storage means so that the second ultrasonic diagnostic image data can be used; having The first transducer array is and transmitting the first sound beam that is inclined at the first angle toward the caudal side of the subject's body when viewed from the normal direction of the reference plane and that intersects with the second sound beam.
2. an extracting means for performing a predetermined signal processing on each of the first and second ultrasonic diagnostic image data generated by the generating means and stored in the storing means, and extracting an image area in which the subject is captured in each of the ultrasonic diagnostic images in the first and second directions; a measuring means for measuring a value of at least one size parameter of the length, area, and volume of the subject based on the extracted image region, and storing the measured size parameter value in a storage means so that the value can be used; 10. The ultrasonic diagnostic imaging probe apparatus of claim 1 further comprising:
3. The generating means, In the contact state, (1) the first acoustic beam is used to electronically scan the subject in the first direction to generate the first ultrasonic diagnostic image data corresponding to a cross-sectional image of the subject, while (2) the second acoustic beam is used to electronically scan the subject in the second direction to generate the second ultrasonic diagnostic image data corresponding to a longitudinal cross-sectional image of the subject, The extraction means performing predetermined signal processing on the ultrasound diagnostic image data corresponding to each of the generated cross-sectional images and longitudinal cross-sectional images, and extracting image regions in which the subject is captured from each of the cross-sectional images and longitudinal cross-sectional images; The measuring means is 3. The ultrasonic diagnostic image processing probe device according to claim 2, further comprising: a measuring section for measuring a size of the object in each of the horizontal, vertical and depth directions based on each of the extracted image regions; and a volume of the object based on the measured values.
4. The first angle is 4. The ultrasonic diagnostic image processing probe apparatus according to claim 1, wherein the second transducer array is set within a transmission angle range of the second sound beam.
5. The second transducer array is 4. The ultrasonic diagnostic image processing probe device according to claim 1, wherein, in the abutting state, (A) the second sound beam is transmitted in a direction inclined at a predetermined second angle toward the tail of the subject's body as viewed from the normal direction, which corresponds to either one of the start point and the end point of the transmission angle range, and (B) the second sound beam is transmitted in a direction inclined at a predetermined third angle toward the head of the subject's body as viewed from the normal direction, which corresponds to the other point of the transmission angle range.
6. The second transducer array, 5. The ultrasonic diagnostic image processing probe device according to claim 4, wherein, in the abutting state, (A) the second sound beam is transmitted in a direction inclined at a predetermined second angle toward the tail of the subject's body as viewed from the normal direction, which corresponds to either one of the start point and the end point of the transmission angle range, and (B) the second sound beam is transmitted in a direction inclined at a predetermined third angle toward the head of the subject's body as viewed from the normal direction, which corresponds to the other point of the transmission angle range.
7. 4. The ultrasonic diagnostic imaging probe apparatus of claim 1, wherein the first angle is set within an angle range of 30 degrees to 60 degrees.
8. 5. The ultrasonic diagnostic imaging probe apparatus of claim 4, wherein the first angle is set within an angle range of 30 degrees to 60 degrees.
9. 6. The ultrasonic diagnostic imaging probe apparatus of claim 5, wherein the first angle is set within an angle range of 30 degrees to 60 degrees.
10. 7. The ultrasonic diagnostic imaging probe apparatus of claim 6, wherein the first angle is set within an angle range of 30 degrees to 60 degrees.
11. The second transducer array, In the contact state, the transducer array is disposed at a position closer to the head of the subject's body than the first transducer array is disposed, The first transducer array is 4. The ultrasonic diagnostic image processing probe device according to claim 1, further comprising: a first sound beam inclined at the first angle toward the tail side opposite to the side where the second transducer array is installed as viewed from the normal direction, the first sound beam intersecting with the second sound beam.
12. The second transducer array, In the contact state, the transducer array is disposed at a position closer to the head of the subject's body than the first transducer array is disposed, The first transducer array is 5. The ultrasonic diagnostic imaging probe apparatus of claim 4, further comprising: a probe for transmitting the first acoustic beam inclined at the first angle toward the tail side opposite the side where the second transducer array is installed as viewed from the normal direction and intersecting the second acoustic beam.
13. The second transducer array, In the contact state, the transducer array is disposed at a position closer to the head of the subject's body than the first transducer array is disposed, The first transducer array is 6. The ultrasonic diagnostic imaging probe apparatus of claim 5, further comprising: a first acoustic beam inclined at the first angle toward the tail side opposite the side where the second transducer array is installed as viewed from the normal direction, the first acoustic beam intersecting the second acoustic beam.
14. The second transducer array, In the contact state, the transducer array is disposed at a position closer to the head of the subject's body than the first transducer array is disposed, The first transducer array is 7. The ultrasonic diagnostic imaging probe apparatus of claim 6, further comprising: a first acoustic beam inclined at the first angle toward the tail side opposite the side where the second transducer array is installed as viewed from the normal direction and intersecting with the second acoustic beam.
15. The second transducer array, In the contact state, the transducer array is disposed at a position closer to the head of the subject's body than the first transducer array is disposed, The first transducer array is 8. The ultrasonic diagnostic imaging probe apparatus of claim 7, further comprising: a first acoustic beam inclined at the first angle toward the tail side opposite the side where the second transducer array is installed as viewed from the normal direction and intersecting with the second acoustic beam.
16. An ultrasound diagnostic device that is used in a state where it is in contact with a body surface on a front side of a subject's body in parallel or approximately parallel, and generates and displays ultrasound diagnostic image data obtained by imaging a subject inside the subject's body, a first sound wave transmitting / receiving means provided in the ultrasound diagnostic device, the first sound wave transmitting / receiving means being configured with a first transducer array arranged along a first direction parallel to a reference plane that is located opposite to a body surface of the subject during imaging, the first sound wave beam being projected onto the subject, and an electrical signal being output as a first output signal; a second acoustic wave transmitting / receiving means configured with a second transducer array arranged along a second direction perpendicular to the first direction and arranged in a substantially T-shape with the first transducer array, the second acoustic wave beam being perpendicular to the first acoustic beam and projected onto the subject within a predetermined transmission angle range, and outputting an electrical signal obtained as a second output signal; having The first transducer array is a probe unit that (1) maintains the first direction parallel or approximately parallel to a cross section of the subject's body part, (2) aligns the second direction along the midline of the subject's body part, and (3) is installed in a state of contact with a predetermined position of the subject's suprapubic bone while aligning the reference plane with the body surface on the front side of the subject's body part, and is inclined at a predetermined first angle caudal to the subject's body part when viewed from a normal direction of the reference plane, and transmits the first sound beam that is inclined at the first angle caudal to the normal direction and crosses the second sound beam; (A1) a driving means for transmitting the first sound beam from the first sound wave transmitting / receiving means, and (A2) a driving means for transmitting the second sound beam from the second sound wave transmitting / receiving means; a generating means for (B1) electronically scanning the subject in the first direction with the first sound beam in the contact state to generate first ultrasonic diagnostic image data of the subject in the first direction, and (B2) electronically scanning the subject in the second direction with the second sound beam to generate second ultrasonic diagnostic image data of the subject in the second direction, and storing the second ultrasonic diagnostic image data in a storage means so that the second ultrasonic diagnostic image data can be used; a display unit that is mounted on the device itself or externally connected and displays an ultrasonic diagnostic image of at least one of a first direction and a second direction of the subject based on at least one of the generated first and second ultrasonic diagnostic image data; a display control means for controlling a display based on the first and second ultrasonic diagnostic image data on the display unit, and causing the display unit to display an ultrasonic diagnostic image in at least one of the first and second directions; An ultrasonic diagnostic apparatus comprising:
17. The driving means In the contact state, the first and second sound beams are alternately transmitted from the first sound wave transmitting / receiving means and the second sound wave transmitting / receiving means for one frame at a time; The generating means, generating the first and second ultrasonic diagnostic image data alternately for one frame each; The display control means 17. The ultrasonic diagnostic device according to claim 16, wherein the ultrasonic diagnostic images captured in the first and second directions substantially simultaneously are synchronized and simultaneously displayed on the display unit in substantially real time based on the first and second ultrasonic diagnostic image data corresponding to each of the alternately generated frames.
18. A urine volume measuring device that is used in a state where it is in contact with a body surface on a front side of a subject's body in parallel or approximately parallel, generates ultrasound diagnostic image data by imaging a bladder in the subject's body, and measures and displays a urine volume in the subject's bladder based on the ultrasound diagnostic image data, a first sound wave transmitting / receiving means provided in the urine volume measuring device, the first sound wave transmitting / receiving means being configured with a first transducer array arranged along a first direction parallel to a reference plane that is positioned opposite to the body surface of the subject during imaging, the first sound wave beam being projected onto the subject, and an electrical signal being output as a first output signal; a second acoustic wave transmitting / receiving means configured with a second transducer array arranged along a second direction perpendicular to the first direction and arranged in a substantially T-shape with the first transducer array, the second acoustic wave beam being perpendicular to the first acoustic beam and projected onto the subject within a predetermined transmission angle range, and outputting an electrical signal obtained as a second output signal; having The first transducer array is a probe unit that (1) maintains the first direction parallel or approximately parallel to a cross section of the subject's body part, (2) aligns the second direction along the midline of the subject's body part, and (3) is installed in a state of contact with a predetermined position of the subject's suprapubic bone while aligning the reference plane with the body surface on the front side of the subject's body part, and is inclined at a predetermined first angle caudal to the subject's body part when viewed from a normal direction of the reference plane, and transmits the first sound beam that is inclined at the first angle caudal to the normal direction and crosses the second sound beam; (A1) a driving means for transmitting the first sound beam from the first sound wave transmitting / receiving means, and (A2) a driving means for transmitting the second sound beam from the second sound wave transmitting / receiving means; a generating means for generating cross-sectional image data corresponding to a cross-sectional image of the bladder by (B1) electronically scanning the subject in the first direction with the first acoustic beam in the contact state, and for (B2) electronically scanning the bladder in the second direction with the second acoustic beam to generate longitudinal section image data corresponding to the longitudinal section image of the bladder, and storing the longitudinal section image data in a storage means so as to be usable; an extraction means for performing a predetermined signal processing on each of the generated image data of the transverse and longitudinal sections stored in the storage means, and extracting an image area in which the bladder is captured from each of the transverse and longitudinal section images; a measuring means for measuring the size of the inside of the bladder in each of the horizontal, vertical and depth directions based on each of the extracted image regions, calculating the volume of the inside of the bladder based on the measured values, and storing the calculated values in a storage means so that they can be used; a display unit mounted on the device itself or externally connected thereto, which displays the calculated value of the bladder volume together with the images of the transverse and longitudinal sections; a display control means for controlling the display of the images of the cross section and the longitudinal section and the display of the bladder volume on the display unit, and for simultaneously displaying on the display unit a calculated value of the bladder volume as a measurement value of the urine volume together with the images of the cross section and the longitudinal section used for measuring the bladder volume; A urine volume measuring device comprising:
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