Attachment with vibrator for measuring biological tissue hardness and biological tissue hardness measuring device including the same

Abstract

To provide a vibrator excellent in handling, which can be pressed simultaneously with probe pressing work, and which applies vibration with a sufficient and stable frequency to a target measurement spot inside a body from the body surface.SOLUTION: An attachment comprises a vibrator configured to be pressed against a biological surface to continuously vibrate biological tissue inside a living body at a constant frequency. The vibrator includes: a yoke having an oscillation space in which a magnetic field is formed; a moving coil loosely inserted to the yoke and swingable in a uniaxial direction; a uniaxial rod-shaped vibrator in which the moving coil is wound and fixed around a base shaft portion; and a casing in which the yoke is inserted. The inside of the yoke is divided at its center and symmetric position by a plurality of partition walls in the axial direction, thereby forming an oscillation space in the form of an open-section comb shape in the axial direction.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] The present invention relates to an attachment with a vibrator for measuring the hardness of biological tissue, which measures the hardness by pressing a measuring device against the biological surface of the vibrated biological tissue while the biological tissue is vibrated, and a biological tissue hardness measuring device equipped with the attachment.

[0002] The vibrator attachment is particularly intended to vibrate the probe transmission and reception signals of an ultrasonic probe that is pressed against the skin surface of a living body. The biological tissue hardness measuring device is configured to include an ultrasonic probe, which is a measuring device, and an attachment with a vibrator for measuring the hardness of biological tissue. [Background technology]

[0003] WO2015 / 151972 (see Patent Document 1) has disclosed an ultrasound imaging method for imaging the biological tissue of a living body (human or animal) using ultrasound. In this disclosure, a puncture needle is pressed against the body surface near the measurement site to vibrate the biological cells at the puncture site, and an ultrasound echo device is used to image the propagation speed of mechanical vibration waves (transverse waves) traveling through the biological tissue.

[0004] In this device, an exciter that imparts minute vibrations to the puncture needle is installed, and the probe receives echo signals that are influenced by the Doppler effect of the puncture needle vibrated by this exciter, thereby allowing the movement of the inner needle protruding from the outer needle of the puncture needle to be recognized.

[0005] This involves placing a vibrator and shear wave probe in contact with the surface of the biological tissue, and analyzing the shear wave images of the vibrations transmitted through the biological tissue to measure the hardness of biological tissue deeper than the surface.On the other hand, the vibration generator (vibrator) that applies vibrations generally comes in moving coil and return motor types. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] WO2015 / 151972A1 publication Summary of the Invention [Problem to be solved by the invention]

[0007] However, many commonly used vibrators, including the tablet echo device described in the above-mentioned document 1, are large and heavy, making them difficult to handle. In particular, to obtain shear wave images of vibrated biological tissues inside the body through body surface vibration, it is necessary to press the probe and vibrator against the body surface simultaneously, which poses a problem in that the vibration frequency attenuates or fluctuates depending on the contact state of the vibrator with the biological tissue.

[0008] Therefore, an object of the present invention is to provide an attachment with a vibrator for measuring the hardness of biological tissue, which is an easy-to-use vibrator that can be pressed against the body in conjunction with the probe pressing operation, and which can apply vibrations at a sufficient and stable frequency to the measurement location inside the body that is to be measured from the body surface, and a biological tissue hardness measuring device equipped with the same. [Means for solving the problem]

[0009] In order to solve the above problems, the present invention takes the following measures: However, in the following description, the numbers or letters following the names of the components are symbols added for the convenience of understanding the drawings, and are not intended to limit the concept, shape, or structure of the components.

[0010] The vibrator attachment of the present invention comprises a vibrator that is pressed against the surface of a living body to continuously vibrate biological tissue within the body at a constant frequency, a cover attachment 12 that can be attached to the probe head of an ultrasonic probe that is pressed against the skin surface of a living body, an enclosure casing that surrounds and holds the vibrator, and joint arms that connect the enclosure casing and the cover attachment at each side.The vibrator is composed of a yoke having an oscillation space that generates a magnetic field, a moving coil that is loosely inserted into the yoke and can oscillate in one axial direction, a uniaxial rod-shaped vibrator with the moving coil wound and fixed around a base shaft, and a casing into which the yoke is inserted, and is characterized in that the inside of the yoke is partitioned at the center and symmetrical positions by a plurality of axial partition walls, thereby forming an oscillation space that is open in the axial direction and has a comb-shaped cross section.

[0011] The vibrator has multiple oscillation spaces extending in the axial direction, thereby ensuring an effective magnetic path cross-sectional area in the axial direction (vertical direction), which makes it difficult for the continuous vibration excitation wave to attenuate until it reaches a great depth, i.e., a great depth.

[0012] The device for measuring the stiffness of biological tissue of the present invention comprises a vibrator that is pressed against the biological surface of a predetermined location of a living organism to apply a constant vibration to the "locomotor function tissue," which is biological tissue involved in the motor function around the joints of the living organism, and a measurement probe that presses a probe surface against the biological surface near the biological surface of the predetermined location while applying a constant vibration to the motor function tissue, and continuously measures the propagation speed of mechanical vibration waves (transverse waves) traveling within the motor function tissue at a predetermined depth from the biological surface by probe-type ultrasonic transmission and reception. Of these, the vibrator is integrally formed by the vibrator-attached attachment, and by attaching the attachment to the probe head of the ultrasonic probe, the vibrator is enclosed and fixed at a predetermined lateral distance from the probe surface and at a predetermined angle relative to the probe probing direction. By adjusting the vibration frequency and amplitude according to the hardness and position of the measurement point, it can be used for a variety of internal biological tissues.

[0013] Furthermore, in an attachment with a vibrator, the attachment includes an enclosure casing that encloses and holds the vibrator, a cover attachment that is fitted and fixed to the head of the probe, and a joint arm that connects the sides of these, The joint arm is configured to include a cylindrical frame protruding from the side of the probe head, a ball joint housed in the lower part of the cylindrical frame, and a protruding arm protruding from the side of the ball joint, and by fixing an enclosing casing to the end of the protruding arm, the vibrator is fixed at a position separated by a predetermined distance and angle in the direction of the side of the probe head.

[0014] The measurement system including the biological tissue hardness measurement device of the present invention comprises: the biological tissue hardness measuring device; a visualization device that processes shear wave data obtained by an ultrasonic probe as a measuring instrument using the C-SWE method, and stores, outputs, and displays the data; The system is composed of a processing device that continuously stores images of the visualized shear wave data, and compares multiple stored images to quantify the amount of change in stiffness information of multiple types of motor function tissues (including muscles, tendons, and ligaments) identified around a specified joint in the same or similar living organism.

[0015] The processing device identifies one or more points among the corners or centers of the outer edge of a skeletal muscle or bone in a specified joint to which the tissue to be measured is connected as joint-specific points, co-stores the image data obtained by the visualization process in a state where it is superimposed on the joint-specific points, and uses the joint-specific points as reference points when comparing multiple images.

[0016] The measurement system including the device for measuring stiffness of biological tissue compares the specific points of the joint in each piece of image data, identifies the biological tissue information around the joint and the key positions (the center of the articular cavity or the articular cartilage) of each piece of biological tissue information, indexes the elasticity information or elasticity change information of the identified multiple key positions, and compares comparable image data among the image data acquired at multiple times, The results of comparing indices of elasticity information or elasticity change information based on the base position of each biological tissue around one joint are displayed together with a comparison of consecutive images.

[0017] Before and after exercise, before and after applying load or changing posture, the video data of the motor function tissue around the joint at a specific location is saved together with the acquired time data and the input code data. The processing device It is preferable to compare video data before and after exercise, and before and after applying load or changing posture, to obtain information on changes in elasticity at each location around a specific joint, and use video analysis to evaluate which type of motor function tissue around a joint, i.e., muscle, tendon, ligament, cartilage, and synovium, is suffering from damage or load in which location, or which muscle is suffering from damage or high load in which location. [Effects of the Invention]

[0018] The present invention provides an easy-to-use vibrator that can be pressed against the body in conjunction with the probe pressing operation, making it possible to apply vibrations at a sufficient and stable frequency to the measurement location inside the body that is to be measured from the body surface.

[0019] [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 is an explanatory diagram of the configuration of a biological stiffness measurement system including the biological tissue stiffness measurement device of Example 1. [Figure 2] FIG. 2 is an explanatory diagram of the configuration of the attachment with a vibrator and the probe head for measuring the stiffness of biological tissue according to the first embodiment before they are attached. [Figure 3] FIG. 2 is a plan view of the attachment with a vibrator for measuring the stiffness of biological tissue according to the first embodiment. [Figure 4] FIG. 3 is a front view of the attachment with the vibrator shown in FIG. 2 and the probe head before they are attached. [Figure 5]1 is a perspective view showing the internal structure of a vibrator of a vibrator-equipped attachment according to a first embodiment, with the center cut away. [Figure 6] FIG. 2 is a front view showing the internal structure of the vibrator and the surrounding casing of the vibrator-equipped attachment of the first embodiment, with the center cut away. [Figure 7] FIG. 10 is a perspective view of an attachment with a vibrator according to a second embodiment. [Figure 8] FIG. 10 is a plan view of the attachment with a vibrator according to the second embodiment. [Figure 9] FIG. 10 is a front view of the attachment with a vibrator and the probe head of the second embodiment before they are attached to each other. DETAILED DESCRIPTION OF THE INVENTION

[0021] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings.

[0022] The present invention relates to an attachment with a vibrator for a biological tissue hardness measuring instrument, and a biological tissue hardness measuring device equipped with this attachment. The biological tissue hardness measuring device is used by pressing the vibrator's vibrator and the probe head PS of the ultrasonic probe, which is the measuring device, against a specific skin surface of a living body, for the purpose of measuring the hardness of a specific biological tissue located a specific depth below the skin surface inside the living body, as shown in Figure 1, for example.

[0023] The vibrator attachment of the present invention is comprised of a cover attachment 1 that holds the probe head of the ultrasonic probe in an attachment-style frame, a vibrator 2 that presses the vibrator against the skin surface of a living body to vibrate the living tissue, an enclosing casing 3 that holds the vibrator in a frame-like shape, and a joint arm 34 that connects the enclosing casing 3, the cover attachment 1, and the enclosing casing 3, all of which are integrally constructed. The joint arm 34 is configured by fixing the enclosing casing 3 to the side of the cover attachment 1 at a position spaced a fixed distance from the cover attachment 1, thereby ensuring a fixed distance. The vibrator 2 is This vibrator is comprised of a yoke having an oscillation space that forms a magnetic field, a moving coil loosely inserted into the yoke and capable of oscillation in one axial direction, a uniaxial rod-shaped vibrator with the moving coil wound and fixed around a base shaft, and a casing into which the yoke is inserted. The inside of the yoke is divided into central and symmetrical positions by a plurality of axial partition walls, thereby forming an oscillation space with a comb-shaped cross section that is open in the axial direction.

[0024] The vibrator has the advantage of ensuring an effective magnetic path cross-sectional area in the axial (vertical) direction by using multiple oscillation spaces extending in the axial direction, making it less susceptible to attenuation. By adjusting the vibration frequency and amplitude according to the hardness and position of the biological tissue to be measured, it can be used for various internal biological tissues.

[0025] The vibrator is characterized in that a plurality of oscillation spaces extending in the axial direction ensure an effective magnetic path cross-sectional area in the vertical direction, which is the axial direction, sufficient for the moving coil to vibrate continuously without attenuation.

[0026] The attachment with the vibrator is further characterized by being equipped with an adjustment mechanism for adjusting the vibration frequency and amplitude according to the biological hardness and position of the biological tissue to be measured and the depth from the biological epidermis to be contacted.

[0027] The joint arm comprises a cylindrical frame protruding from the side of the probe head, a ball joint housed in the lower part of the cylindrical frame, a protruding arm protruding from the side of the ball joint, and an enclosing casing fixed to the tip of the protruding arm, and the vibrator is held and fixed to the side of the probe head by the enclosing casing.

[0028] The device for measuring the hardness of biological tissue comprises a vibrator for the biological tissue hardness measuring device and a cover attachment removably fixed to the probe head of the ultrasonic probe, which are fixed via a joint arm at a position spaced a predetermined distance and a predetermined angle to the side of the probe head.

[0029] The vibrator is This vibrator is composed of a yoke having an oscillation space that forms a magnetic field, a moving coil that is loosely inserted into the yoke and can oscillate in one axial direction, a uniaxial rod-shaped vibrating body with the moving coil wound and fixed around a base shaft, and a casing into which the yoke is inserted.The inside of the yoke is divided into central and symmetrical positions by multiple axial partition walls, thereby forming an oscillation space that is open in the axial direction and has a comb-shaped cross section.

[0030] A measuring device in which the vibrator is fixed to a position separated by a predetermined distance and angle in a lateral direction of the probe head via an attachment fixed to the head of the probe, The probe head is characterized by comprising a cylindrical shaft frame protruding from the side of the probe head, a ball joint housed in the lower part of the cylindrical shaft frame, a protruding arm protruding from the side of the ball joint, and an enclosure holder fixed to the tip of the protruding arm, and the vibrator is held by the enclosure holder.

[0031] A structural feature of the above-mentioned vibrator is that the effective magnetic path area is expanded in the vertical direction, thereby increasing the effective area where the magnetic path comes into contact, and realizing a compact structure covered by a small casing.

[0032] The use of a biological tissue hardness measuring device equipped with the attachment allows the vibrator to be easily pressed against concave biological surfaces such as the back of an elbow or knee joint, or curved biological surfaces such as the boundary between the thigh or upper arm and a joint, due to its compact size. The placement of the ultrasonic probe and vibrator is not greatly restricted, making it easy to handle. Furthermore, the vibrator is equipped with a rod-shaped vibrator that protrudes axially from the central end of the casing, making it easy to recognize the vibration direction of the vibrator. This vibrator can generate vibrations targeted at specific biological tissues (muscles, cartilage, tendons, and ligaments) around joints located at a predetermined depth in a specific direction from the skin surface of the living body. It also has excellent heat dissipation properties.

[0033] Furthermore, this vibrator and a cover attachment that is spaced a certain distance to the side of the vibrator casing are connected by a joint arm to form an attachment with a vibrator, and by combining this attachment with an ultrasonic probe that has a probe head with a built-in general-purpose ultrasonic probe, a compact, easy-to-use hardness testing and measuring device can be obtained.

[0034] In particular, the yoke with its distinctive swing space shape secures the cross-sectional area of ​​the effective magnetic path, and by making the cross-sectional area of ​​the front face of the longitudinal vibrator small, it is possible to obtain a stable vibration output at a distant location in the vibration propagation direction.It also has excellent heat dissipation properties and is easy to handle when pressed against a living body.

[0035] In addition, by using a ball joint attachment, the measuring instrument has excellent operability for simultaneous pressing with the probe.

[0036] The vibrator for the biological tissue stiffness measuring device and the measuring device equipped with the vibrator are used by being incorporated into a biological stiffness measuring system such as that shown in FIG.

[0037] The biological stiffness measurement system shown in Figure 1 is composed of a biological stiffness measurement processing program 1 equipped with heat dissipation fins, a vibration device 2 that applies vibration, an adjuster A that can synchronize the vibration frequency, a display device HD that displays the propagation velocity detected by the probe in two dimensions, a processing terminal 4 that stores and saves data, and a monitor M.

[0038] The biological tissue hardness testing device of the present invention is composed of a vibrator that applies a constant vibration to the motor function tissue, which is biological tissue involved in the motor function around the joints of the living body, by pressing it against the biological surface at a predetermined location of the living body, and a measurement probe that applies a constant vibration to the motor function tissue by pressing the probe surface against the biological surface near the biological surface at the predetermined location, and continuously measuring the propagation speed of mechanical vibration waves (transverse waves) traveling within the motor function tissue at a predetermined depth from the biological surface by probe-type ultrasonic transmission and reception. The vibrator 2 is This vibrator is composed of a yoke having an oscillation space that forms a magnetic field, a moving coil that is loosely inserted into the yoke and can oscillate in one axial direction, a uniaxial rod-shaped vibrating body with the moving coil wound and fixed around a base shaft, and a casing into which the yoke is inserted.The inside of the yoke is divided into central and symmetrical positions by multiple axial partition walls, thereby forming an oscillation space that is open in the axial direction and has a comb-shaped cross section.

[0039] The measurement system of the present invention is configured to include, in addition to the biological tissue stiffness measurement device, a visualization device that visualizes shear wave data from the measurement device using the C-SWE method, and stores, outputs, and displays the data; and a processing device that continuously stores images of the visualized shear wave data, and compares multiple stored images of stiffness information for multiple types of motor function tissues (including muscles, tendons, and ligaments) identified around a specified joint in the same or similar biological organism, and quantifies the amount of change.

[0040] The biological hardness measuring device is Among the biological tissues around a specific joint of a specific living body, a specific motor function tissue among muscles, tendons, and ligaments is set as the measurement target tissue, The measurement system is a system that measures the hardness of the tissue to be measured and outputs the evaluation results of the motor function of the living body through the digitization and visualization of the measurement data.

[0041] (An attachment that can be attached to the head of an ultrasound probe) a first attachment that can be attached to a head portion of the ultrasonic probe; a second attachment for holding a vibrator that applies mechanical vibration to a surface of a living body, In the transmitting and receiving direction of the probe probe of the ultrasonic probe attached by the first attachment, than the probe surface of the ultrasonic probe attached by the first attachment, The vibrator of the vibrator held by the second attachment is protruded by a predetermined preset value of protrusion amount, and The distance between the probe surface and the oscillator can be kept constant within a predetermined preset range.

[0042] In order to mechanically vibrate biological tissue using an oscillator, it is necessary to transmit the vibration to tissues below the epidermis and subcutaneous fat layers on the surface of the body. By protruding the oscillator from the surface of the body using the above-mentioned means, it is possible to apply pressure to the skin on the surface of the body, maintaining the surface tissue in a compressed state with high vibration propagation efficiency, while reliably vibrating the biological tissue mechanically. Furthermore, by maintaining a certain distance from the excitation point that is not too far, it is possible to reliably obtain the vibration propagation velocity at any measurement point within a range of approximately 10 cm from the epidermis of the vibrating biological tissue.

[0043] (Cushioning material for the second attachment) a first attachment having an insertion frame into which a head portion of an ultrasonic probe can be inserted from a side periphery; a second attachment that holds a vibrator that applies mechanical vibration to a living body surface in the holding hole and at a tip of the holding hole, The vibrator is fixed to the inner surface and tip surface of the holding hole of the second attachment with a buffer material interposed between the base and tip of the vibrator.

[0044] the first attachment has a fitting frame having a tapered frame hole into which a head of an ultrasonic probe is fitted, the second attachment has a holding hole that receives and holds a columnar vibration base of the vibration exciter, The present invention is also characterized in that an adjustment connection portion is provided between the first attachment and the second attachment, which allows sliding adjustment of the positional relationship between the tapered frame hole and the holding hole in the hole axis direction.

[0045] The adjustable connecting portion maintains the retaining hole axis in a parallel or inclined direction approaching the front side in relation to the frame hole axial direction of the fitting frame, and maintains the retaining hole at an arbitrary set protrusion amount so that it protrudes a predetermined set amount further forward than the tapered frame hole.

[0046] the first attachment has a fitting frame having a tapered frame hole into which a head of an ultrasonic probe is fitted, the second attachment has a holding hole that receives and holds a columnar vibration base of the vibration exciter, The present invention is also characterized in that an adjustable connecting portion is provided between the first attachment and the second attachment, which allows bending and adjustment of the angular relationship between the tapered frame hole and the holding hole in the hole axis direction. The adjustable connecting portion maintains the retaining hole so that it protrudes a predetermined set amount further forward than the tapered frame hole, and in relation to the frame hole axis direction of the fitting frame, the retaining hole axis is maintained at an arbitrary set angle so that it faces parallel or in a direction inclined at an arbitrary angle toward the forward side (relative to the frame hole axis direction of the fitting frame).

[0047] The tapered frame hole of the first attachment and the holding hole of the second attachment have one or more slits formed on the inner surface of the hole, which are characterized by being in an elastically deformed state when the ultrasonic probe is inserted or the vibrator is held and housed. The natural vibration frequency can be adjusted, and resonance can be prevented.

[0048] (Joint arm (connecting jig)) The biological stiffness measurement processing program described above is characterized in that it further comprises a protruding piece that protrudes parallel to the transmitting and receiving surface of the probe so that the transmitting and receiving unit of the probe maintains a constant angle approximately perpendicular to the scanning surface. Also, it is characterized in that the tapered frame hole of the first attachment and the holding hole of the second attachment are formed as a continuous space without a partition on one side and the other side of one frame hole, and are deformable and adjustable by external force and maintain the adjusted deformed state.

[0049] The objective is to develop a noise reduction technology that can obtain images of biological tissue stiffness using the CD-SWI method even with ultrasound diagnostic equipment that produces a lot of noise. In noise reduction processing, it is important to focus on the time and frequency characteristics of the original signal obtained by the ultrasound diagnostic equipment that are specific to the CD-SWI method, and to extract and emphasize only the signals that have these characteristics. This invention actively utilizes the characteristic of the original signal in stiffness images obtained by the CD-SWI method, that "the excitation to excite shear waves in biological tissue is performed with a continuous sine wave of a specific frequency." Specifically, we have developed a Moving Target Inversion (MTI) that is specialized for sine wave excitation. By introducing noise reduction technology specialized for sinusoidal excitation, which includes two methods: a Target Indicator (Target Indicator) filter and flow velocity estimation specialized for sinusoidal excitation, it is possible to obtain stiffness images and perform quantitative stiffness measurements even with a biostiffness measurement processing program with high noise, such as a tablet-type biostiffness measurement processing program.

[0050] For example, a control device 2 connected in parallel to two detection devices P1 and P2 by wire includes a memory unit R, a processing device M2, and an input device I2, and signals corresponding to the channels of each receiver are connected to the processing device 1 by a cable C. The processing device 1 is provided with a switch S, an adjustment device V, a speaker, and locking units for the detection devices P1 and P2, and is connected to the processing device M1 and input device I by wire or wirelessly.

[0051] A vibrating transducer (S) excites shear waves in biological tissue, which propagate through the tissue. At the same time, an ultrasound probe (P) transmits ultrasound waves. The ultrasound waves reflected from the tissue and received by the ultrasound probe exhibit a slightly modulated frequency due to the Doppler effect caused by the excitation. The transducer is equipped with an amplifier, an oscillator, and a control device that determines the oscillation frequency. The signal obtained by the ultrasound probe is processed and saved as video data by an imaging device. After quadrature detection, the signal is input as an IQ signal to a processing device (AW) such as a PC or tablet. The present invention relates to noise reduction technology incorporated into this processing device. The final image is displayed by a processing device (W).

[0052] (Biofunctional tissue (musculoskeletal system) evaluation program) The evaluation program for biological functional tissue (musculoskeletal system) of the present invention comprises any one of the above biological stiffness measurement processing programs for acquiring probe data without contact, and an evaluation device for analyzing and evaluating the acquired probe data. The biological stiffness measurement processing program in this biological functional tissue (musculoskeletal system) evaluation program method is used to test the stiffness of locomotor function tissues related to joint function, such as muscles, tendons, and ligaments, as well as to detect joint capsules, synovial membranes, glenoid fossa, and articular cartilage.

[0053] The biological hardness measurement processing program includes: an acquisition unit for vibration propagation velocity data by a head unit of an ultrasonic probe; an A / D conversion unit for the propagation velocity data acquired by the acquisition unit; A measurement processing program including a calculation unit that calculates data after A / D conversion of propagation velocity data and converts it into visualization data, and a memory unit that stores the visualization data, The calculation unit continuously acquires image frames consisting of one B-mode image followed by 16 color Doppler images at each unit time and overwrites and saves them in a memory unit within a set range, and is characterized by having a continuous analysis unit that analyzes the acquired image set using a unit image set of 18 to 31 images including one B-mode image.

[0054] The biological hardness measurement processing program A first analysis unit is continuously provided for analyzing the acquired image set using a unit image set of 18 to 31 images including one B-mode image, A biological stiffness measurement processing program, characterized by having a second analysis unit that has a series of acquired image sets that are shifted from the first analysis unit by an amount of shift of 18 to 31 images.

[0055] The biological stiffness measurement processing program is characterized in that the acquired ultrasonic data is aspherical data.

[0056] The present invention stores image data of the motor function tissue around a specific joint before and after exercise, before and after applying load or changing posture, together with the acquired time data and input code data, The processing device The system compares video data before and after exercise, and before and after applying load or changing posture, and outputs an evaluation result of the functional health of the motor function tissue based on one or more of the following: changes in elasticity based on stiffness indexes, changes in volume based on length and width measurements, and changes in curvature at each position of the central curve in the longitudinal direction of the motor function tissue.

[0057] The evaluation results are shown by quantifying or displaying in text an explanatory text or as an image which motor function tissue that controls the movement of a musculoskeletal system of a specific living organism is impaired when viewed from the joint center. The tendons and ligaments in a musculoskeletal system are subject to passive forces from external muscles, controlling posture changes and movement relative to the muscles. While muscles can only contract, tendons and ligaments can stretch and contract. Stretching or contracting tendons and ligaments generate muscle reaction forces. Taking this into consideration, by detecting changes in elasticity during tendon and ligament stretching (how much the elasticity of each motor function tissue increases as a result of stretching) and comparing these changes before and after exercise, or during relaxation and contraction, it is possible to evaluate whether the musculoskeletal system is receiving external forces and whether the ligaments are stretching and generating muscle reaction forces. Based on this, it is possible to output evaluation results such as the health of motor function tissue units and the risk of injury.

[0058] For example, measurements are taken of the locomotor system around a specific joint of a specific living individual before and after posture changes (whether or not there is extension and flexion), muscle loading (whether or not there is weight loading), and a specific period of walking, running, sports competition, or other exercise, to obtain video data on the surface elasticity and internal elasticity of the locomotor function tissue. By comparing these data before and after and measuring the amount and rate of change in elasticity, it is possible to evaluate which parts of the muscles, tendons, or ligaments are functioning normally and which parts of the muscles, tendons, or ligaments are functioning abnormally, based on numerical or positional elements.

[0059] When displaying the evaluation results, together with or in addition to the numerical value of the evaluation results or the explanatory text, it is also possible to display video data of before and after a change in posture, before and after applying load to the musculoskeletal system, and before and after the elasticity of the motor function tissue changes due to exercise as first video data and second video data, either as an overlaid display with transparency, or as an animated video display with continuous changes.

[0060] The evaluation of the functional integrity of motor function tissue is based on the following points: the change in elasticity relative to adjacent change positions at each position along the length of the tissue structure, i.e., the rate of change, is within a certain range (for example, within 30%); the outer shape is smooth and the rate of change in the slope of the outer curve is within a certain range (for example, 20% or less); and the dispersion of hardness data within the motor function tissue area indicates the presence of missing parts such as chips or cracks, the presence of damaged parts such as depressions or holes, and the presence of parts with a large change in elasticity that are more solidified than the surrounding tissue structures.

[0061] Furthermore, by using a processing device to measure elasticity changes at high resolution using the least squares error method, it is now possible to measure even extremely high shear wave velocities in motor function tissues such as tendons and ligaments, making it possible to measure even areas where the motor function tissue has become extremely stiff due to, for example, weight loading or changes in posture.

[0062] High-resolution, high-precision processing is possible with inexpensive equipment, and real-time elasticity measurement has made it possible to perform highly accurate functional diagnostic evaluations of motor function tissues.

[0063] In particular, by changing the measurement depth of the probe, it is possible to estimate not only the surface hardness of the motor function tissue but also the hardness inside the tissue. By comparing the changes in surface hardness and internal hardness of the motor function tissue in the same location of the same living body with images taken before and after a period or time, it is possible to estimate ligament inflammation and damage, tendon rupture, muscle rupture, as well as their precursors and the presence or absence of internal bleeding. It is also possible to estimate the condition and function of the muscles that cause the movement of joint structures.

[0064] In addition to the above, the ultrasonic signals received by each transducer are spectrally analyzed, and through a learned multi-layer neural network analysis, the foreign object is classified into one of several object spectrum models differing in size or hardness, and the classified object spectrum model is displayed on a map with a color or shape that corresponds one-to-one to the classified object spectrum model, creating a map display tailored to the detection surface.By detecting signals by overlapping each of the multiple receivers arranged two-dimensionally with adjacent receivers, the general shape and thickness (depth) of the foreign object can be clearly recognized.

Claims

1. The ultrasonic probe is integrally configured by including a cover attachment that holds the probe head of the ultrasonic probe in an attachment-type frame, a vibrator that presses a vibrator against the skin surface of a living body to vibrate the living body tissue, a casing that holds the vibrator in a frame shape, and a joint arm 34 that connects the cover attachment and the surrounding casing 3 at their respective sides so that they are spaced apart from each other, The vibrator is an attachment with a vibrator for measuring the hardness of biological tissue, characterized in that the vibrator is composed of a yoke having an oscillation space that forms a magnetic field, a moving coil that is loosely inserted into the yoke and can oscillate in one axial direction, a uniaxial rod-shaped vibrating body with the moving coil wound and fixed around a base shaft, and a casing into which the yoke is inserted, and the inside of the yoke is divided into central and symmetrical positions by multiple axial partition walls, thereby forming an oscillation space that is open in the axial direction and has a comb-shaped cross section.

2. 2. An attachment with a vibrator for measuring the hardness of biological tissue as described in claim 1, wherein the vibrator has a plurality of oscillation spaces extending in the axial direction, which ensures an effective magnetic path cross-sectional area in the axial direction, i.e., vertical direction, sufficient for the moving coil to continue vibrating without attenuation.

3. 2. The attachment with a vibrator for measuring the stiffness of biological tissue according to claim 1, further comprising an adjustment mechanism for adjusting the frequency and amplitude of vibration depending on the stiffness and position of the measurement location.

4. 10. A device for measuring the hardness of biological tissue, comprising: a vibrator for a biological tissue hardness measuring instrument according to claim 1; and a cover attachment detachably fixed to a probe head of an ultrasonic probe, fixed via a joint arm at a position spaced a predetermined distance and a predetermined angle to the side of the probe head, a cylindrical frame protruding from the side of the probe head, a ball joint housed in the lower part of the cylindrical frame, a protruding arm protruding from the side of the ball joint, and an enclosing casing fixed to the tip of the protruding arm, wherein the vibrator is held and fixed to the side of the probe head by the enclosing casing.

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