Breast diagnosis and treatment equipment

Abstract

The present invention provides a breast diagnosis and treatment device, specifically a medical device for human breast examination and treatment, including: a diagnosis and treatment bed that places the examinee in a prone position, a fixing part that shapes the examinee's breast, a palpation detection part that collects the examinee's breast pressure distribution data, an ultrasonic detection part that performs ultrasonic examination on the examinee's breast, a mechanical carrier that drives the palpation detection part and / or the ultrasonic detection part to move the position, and an adjustment member that adjusts the pressure between the palpation detection part, the ultrasonic detection part and the examinee's breast. The present invention adopts a prone position examination and can automatically complete the examination of the examinee's breast, replacing the traditional manual touch examination or ultrasonic examination, which not only facilitates the doctor's operation, but also reduces the doctor's workload and improves the accuracy of the examination.

Description

Technical Field

[0001] The invention relates to medical equipment for contact-type automatic examination and treatment of human breasts, belonging to the technical field of medical devices, and in particular to breast diagnosis and treatment equipment. Background Art

[0002] The mammary gland is an accessory gland of the skin and is a compound tubulo-alveolar gland. The male mammary gland gradually degenerates at around one and a half years old. The gland has ducts but no alveoli and is not lobed. The female mammary gland proliferates during puberty and is nearly mature after the onset of menstruation. In recent years, the mortality rate caused by breast cancer has been gradually increasing. The main reason is that breast cancer is discovered too late. Early diagnosis and treatment is an important measure to improve the survival rate of breast cancer patients, reduce mortality, and reduce medical expenses. Regular breast examination is the best choice for early detection of breast cancer. At present, hospitals usually use palpation imaging, mammography, ultrasound, optical imaging, magnetic resonance imaging (MRI), near-infrared breast scanning and other methods to detect patients. Since the equipment for these tests is set up in the hospital and must be performed by doctors, patients need to go to the hospital for breast screening. This inconvenience makes patients miss the opportunity to detect the disease early.

[0003] At present, autonomous breast examination equipment has appeared, which can automatically scan and analyze the patient's breast under the patient's autonomous operation without the involvement of a doctor. The autonomous breast examination equipment requires the patient to lie on the breast examination bed with his back, and use a robotic arm to drive the scanning probe to move on the patient's breast according to a predetermined trajectory to obtain an ultrasound image of the breast, and then analyze the acquired image to obtain the result of whether there is a suspicious lesion. In addition, the current breast palpation examination is mainly based on manual touch screening and detection, which cannot guarantee the accuracy of the screening well, and the labor intensity of the doctor is also very high. The pressure of the palpation probe has a certain impact on the imaging quality of the image, and cannot provide consistent examination accuracy.

[0004] According to current clinical research, it is feasible for breast cancer patients to perform three-dimensional conformal scanning based on the prone position in a free-breathing state. The patient lies prone on the examination bed, and the breasts droop naturally. The prone position has obvious advantages over the supine position in terms of detection accuracy and individualized treatment. However, when the patient is in the prone position, the naturally drooping breasts need to be restrained so that the scanning probe can perform three-dimensional conformal detection and diagnosis and treatment.

[0005] In order to solve the problem of shape constraint of the breast to be examined when the patient is in prone position and to enable various scanning probes to perform fully automatic detection and treatment of the breast, researchers are urgently needed to develop a breast diagnosis and treatment device. Summary of the invention

[0006] 1. Technical issues to be resolved

[0007] The purpose of the present invention is to provide a breast diagnosis and treatment device, which is mainly used for fully automatic detection and treatment of the breasts of the examinee. First, it solves the technical problem that the existing palpation equipment cannot perform fully automatic detection of the breasts of the examinee; second, it solves the plastic constraint problem of the breasts of the examinee so that three-dimensional conformal scanning detection can be implemented; third, it solves the technical problem that the palpation inspection pressure and ultrasonic inspection pressure cannot be controlled during detection, and the inspection accuracy cannot be guaranteed.

[0008] (II) Technical solution

[0009] In order to solve the above technical problems, the present invention provides a breast diagnosis and treatment device, including a diagnosis and treatment bed for placing an examinee in a prone position, the diagnosis and treatment bed is provided with a through hole for allowing the examinee's breast to pass through, a fixing part is carried on the through hole, the fixing part uses a rigid frame to support an elastic membrane, the elastic membrane can be deformed to fit and cover the breast to be detected, elastically constrain the examinee's breast, and shape and fix the examinee's breast into a shape that is conducive to breast diagnosis and treatment, and also includes: a diagnosis and treatment body, a mechanical carrier, and an adjustment component, the diagnosis and treatment body is arranged on the diagnosis and treatment bed, and the examinee is in a prone position on the diagnosis and treatment bed, and the examinee is suspended from the through hole of the diagnosis and treatment bed. Around the breast, the diagnosis and treatment body is at least provided with a palpation detection unit, and the palpation detection unit uses a CMUT linear array to collect pressure distribution data of lesions in the breast of the subject in a moving touch pressure manner; the mechanical carrier is arranged at the lower part of the diagnosis and treatment bed, drives the diagnosis and treatment body to move in position to detect the breast of the subject, and the mechanical carrier includes a controller for controlling the diagnosis and treatment body to move in the vertical and horizontal directions and conform to the curved surface of the breast of the subject; the adjustment component is connected to the controller, and is placed on the mechanical carrier to change and adjust the pressure between the diagnosis and treatment body and the breast of the subject.

[0010] The diagnosis and treatment bed includes: a prone bed plate, a bracket, a base, and a pulley. The prone bed plate is provided with a through hole for the breast to pass through. The bracket supports the prone bed plate and forms a ground clearance with the ground. The diagnosis and treatment bed also includes a fixing part for breast scanning, and the fixing part is detachably connected to the through hole. The base is connected to the bracket, and a pulley is provided at the bottom of the base, and the diagnosis and treatment bed moves via the pulley. The diagnosis and treatment bed is easy to move and can be moved to any place for the detection and diagnosis and treatment of human breast tissue. The diagnosis and treatment bed is mainly used for the subject to lie prone on the bed, and the detection and diagnosis and treatment of human breast tissue is carried out under the premise of ensuring the comfort of the patient.

[0011] The fixing part is used for shaping and fixing the breast, which can be permanent or semi-permanent, and sterilized after each patient uses it. Of course, it can also be disposable or regenerable, and replaced after each patient uses it. The rigid frame of the fixing part is provided with a through area that conforms to the breast base. After the breast passes through the through area, the skin around the breast fits on the upper surface of the rigid frame; the elastic membrane is fixed on the rigid frame, covering at least a part of the through area, and the elastic membrane is stretched open by the rigid frame to provide an elastic surface, and the elastic surface can be deformed to fit and cover the breast to be scanned. The rigid frame is made of medical plastic material or metal material, and can be a flat plate or a three-dimensional shape suitable for the curve of the human chest. The elastic membrane is made of fiber filaments and polyester filaments interwoven by a knitting machine, and the structure is a mesh tissue structure, which has the advantages of softness and good elasticity, and has no adverse effects on ultrasonic examination and auxiliary puncture. The elastic membrane can be transparent to allow the breast to be shaped and fixed to be observed through it. The elastic membrane material includes nylon, crystal, core-spun, polyester amine and other materials, and the natural or synthetic fibers can be assembled together into an interlocking arrangement by weaving, spinning or synthesizing. The weaving gap of the elastic surface is smaller than the average weaving gap of the elastic membrane, and the thickness of the elastic surface is preferably less than 0.3 mm, and the breast is shaped and fixed with a force of 2 to 30 pounds. When the human body is in a prone position, the elastic surface is shaped and fixed from bottom to top, roughly toward the direction of the human chest cavity, to assist the palpation detection unit in scanning.

[0012] The elastic membrane is provided with a mark on the visible part of the through-area, so that when the breast passes through the through-area, it is convenient to control the relative position of the breast and the elastic surface of the elastic membrane to be correct. The mark can be at least one of a dotted line form, a target form, a grid shape, and an arrow shape. With the indication of the mark, the examinee voluntarily passes the breast through the through-area, and the breast is relative to the correct position of the elastic surface of the elastic membrane, so that the examinee's prone action is completed, and the body lies prone on the examination bed. The mark uses a visible boundary to show the position where the breast should be placed. The visible boundary can also display other useful information, such as: scanning boundary, scanning trajectory, preferred position, lesion position, etc. In addition, a small round hole is opened at the center of the elastic surface of the elastic membrane. When the breast passes through the through-area, the nipple passes through the small round hole, so that the elastic surface is closely attached to the breast, forming a close contact with the breast skin. The shape of the normal sagging breast of the human body in the prone position is cone-shaped, bilaterally symmetrical, the nipple protrudes, and the nipple and the epidermis are slightly high density, so the nipple passes through the above-mentioned small round hole, and the auxiliary elastic surface is tightly attached to the breast.

[0013] The elastic membrane is coated with an acoustically transparent liquid, which can penetrate the elastic membrane. The acoustically transparent liquid refers to a liquid whose acoustic impedance is not higher than that of water. The acoustically transparent liquid can be an acoustic coupling agent. The elastic membrane can be pre-impregnated with the acoustic coupling agent or penetrated by the acoustic coupling agent, and the acoustic coupling agent is directly applied to the breast.

[0014] The diagnosis and treatment main body is provided with a palpation detection unit, and other detection units may also be provided, which will be described in detail below. The palpation detection unit here refers to the principle of using bionic simulation of tactile perception of different tissue differences, applying a dynamic or static force to the tissue, and due to the physical laws of elastic mechanics and biomechanics, the tissue will respond with a reaction force, and the palpation detection unit will then collect pressure distribution data of different biological tissues. Because the elastic pressures produced by different biological tissues are different, such as normal tissue and tumor tissue, benign tumors and malignant tumors, the responses produced are also different, palpation can perceive these differences, such as the size, hardness, shape, etc. of the tumor, and then after comprehensive analysis of the data, diagnosis is performed. The palpation detection unit can be a probe part composed of a CMUT linear array, a circuit board, and a cable, and an acquisition card system, a host, etc. are provided on the outside, and the two are connected by cables to form a palpation imaging system. Of course, the palpation detection unit can also be a wireless palpation imaging system composed of a CMUT linear array, a circuit board, an acquisition card system, a host, a battery, etc., and then connected to an external display device wirelessly.

[0015] The CMUT linear array specifically refers to a capacitive micromechanical ultrasonic transducer (CMUT), which is a parallel plate capacitor made on a silicon substrate using MEMS micromachining technology. The elastic thin plate of the capacitor is used to realize the emission and detection of ultrasonic waves. It is an ultrasonic transducer based on the electrostatic energy conversion mechanism. CMUT has the advantages of high sensitivity, good matching of bandwidth and dielectric impedance, and is suitable for array manufacturing. It also includes the advantages of compatibility with magnetic resonance imaging, adjustable sensitivity, and firm devices. The CMUT linear array design facilitates the design combination of structural units and functional units in the CMUT, which is conducive to multimodal diagnosis and treatment applications. The structural unit and the functional unit are the smallest structural unit and the smallest functional unit of the CMUT, respectively. When the CMUT linear array structure is used for touch pressure, its working principle is: under the action of external force, the elastic film is deformed in the direction of the cavity by force, so that the polar distance of the capacitor becomes smaller, thereby increasing the capacitance value. At the same time, as the pressure is greater, the deformation of the film is greater, and the capacitance change is greater. On the contrary, when the pressure is released, the film recovers under the action of its own elastic force, the polar distance of the capacitor becomes larger, and the basic capacitance value of the capacitor is recovered. According to the change of the distance between the upper and lower electrodes and the difference in tissue elasticity, the "electronic tactile bodies" prepared by the CMUT functional unit can be arranged regularly as needed to form "artificial skin" to sense the touch and pressure sensation by simulating the touch and pressure inspection process of human fingers. Simply put, under the same external force, the tissue with a larger elastic coefficient in the organ, commonly known as harder, will cause a smaller strain; conversely, the tissue with a smaller elastic coefficient, commonly known as softer, will cause a larger corresponding strain. In other words, the deformation degree of the softer normal tissue exceeds that of the harder tumor tissue. Palpation tissue elastic imaging uses the difference in elastic coefficient between tumors or other lesions and surrounding normal tissues to produce different strain sizes under the same stress, and displays the elasticity of the lesion tissue in the form of color coding, thereby inferring the possibility of certain lesions. Palpation imaging has a good diagnostic effect on focal lesions such as breast tumors and milk stasis, but it is difficult to identify whether the lesion is cystic or solid, and it cannot achieve the depth of the lesion in the breast and the three-dimensional shape of the mass.

[0016] The mechanical carrier drives the palpation detection part to move, and uses the adjustment member to examine the entire breast of the examinee from left to right or from top to bottom in a sliding displacement manner with relatively consistent pressure during the pressure palpation examination at the palpation detection part.

[0017] Preferably, the CMUT linear array used in the palpation detection unit is a linear array composed of 1 x 16 capacitive micromechanical ultrasonic sensor functional units, which is used to obtain the pressure distribution image of the lesion in the breast. The CMUT linear array can be designed as a 1x16 linear array (2180 μm wide and 38000 μm long), which can achieve good imaging effects when the subject's breast is touched and pressed from left to right or from top to bottom in a sliding displacement manner with relatively consistent touch pressure.

[0018] Preferably, an ultrasonic detection unit is also provided on the diagnosis and treatment body. The ultrasonic detection unit uses a CMUT linear array as an integrated ultrasonic transceiver, and is located on one side adjacent to the palpation detection unit. The ultrasonic detection unit is used to perform ultrasonic examination on the subject's breast. Ultrasonic examination has advantages in distinguishing whether the lesion is cystic or solid, and can measure the depth of the lesion in the breast and image the three-dimensional shape of the mass. The ultrasonic detection unit can be an ultrasonic detection system composed of an ultrasonic probe, a transmitting / receiving device, an echo data processing device, a display control device, an operating device, etc. Of course, the ultrasonic detection unit can also be a wireless ultrasonic detection system that integrates a transmitting / receiving device, an echo data processing device, a display control device, a battery, etc., and then uses an external display device to display the image.

[0019] Preferably, the adjustment member includes a pressure sensor, which is in continuous contact with the subject's breast, feeds back pressure data collected by the pressure sensor at the contact position, and controls the adjustment member to change and adjust the pressure between the diagnosis and treatment body and the surface of the subject's breast based on the pressure data. During the inspection, both the palpation detection unit and the ultrasound detection unit need to apply pressure to the subject's breast with a consistent inspection pressure, from left to right or from top to bottom, in a sliding displacement manner, which can achieve good palpation imaging effects and ultrasound imaging effects, and ensure the accuracy of the inspection.

[0020] Preferably, the diagnosis and treatment body is also provided with an ultrasonic treatment part, which uses the ultrasonic waves emitted by the CMUT treatment transducer to converge at one point to form the focus of the CMUT treatment transducer, which is used to act on the breast lesions of the subject, and utilize the cavitation effect of the ultrasonic waves to loosen the breast lesions or milk curds; and utilize the focused energy to perform precise positioning treatment of the tumor.

[0021] Preferably, the adjustment member includes a displacement sensor, which measures the distance data between the ultrasound treatment part and the subject's breast, and adjusts the distance between the ultrasound treatment part of the diagnosis and treatment body and the surface of the subject's breast based on the distance data. When the ultrasound treatment part treats the subject's breast tumor, it is necessary to adjust the distance between the ultrasound treatment part and the subject's breast so that the ultrasound waves emitted by the ultrasound treatment part converge at one point to form the focus of the transducer array, thereby treating the subject's breast tumor.

[0022] Preferably, the mechanical carrier includes a lifting component, a translation component and a rotating component, the lifting component is used to move the palpation detection part of the diagnosis and treatment body in the vertical direction; the translation component is used to move the palpation detection part of the diagnosis and treatment body in the horizontal direction; the rotating component controls the palpation detection part of the diagnosis and treatment body to form a certain angle with the horizontal plane to diagnose the breast of the examinee, so that the diagnosis and treatment body moves conformably along the curved surface of the examinee's breast.

[0023] The lifting component is used for displacement in the Z-axis direction, and includes a lifting rod, a rack fixed on one side of the lifting rod, a gear meshing with the rack, and a first servo motor driving the gear to rotate. The lifting rod is slidably connected to the translation component, and its upper end is fixedly connected to the adjustment member. The first servo motor is connected to the controller. The translation component is used for displacement in the X-axis and Y-axis directions, and includes a translation slide through which the lifting rod slides, a translation base slidably connected to the translation slide, two pulleys arranged in parallel on the translation base, and a second servo motor driving any one of the pulleys to rotate. The translation slide moves along the length direction of the translation base, and the translation slide moves along its own width direction. The second servo motor is connected to the controller. The rotating component can control the diagnosis and treatment body to be at a certain angle to the horizontal plane to diagnose the breast of the subject. Specifically, a mechanical arm can be used. The mechanical arm adjusts the pressure angle through multi-axis rotation and movement, so that the diagnosis and treatment body moves conformably along the arc surface of the subject's breast.

[0024] Preferably, the device also includes a puncture needle, a positioning hole is provided in the middle position of the ultrasonic detection part, the lower end of the puncture needle extends into the positioning hole, and the upper end is exposed outside the ultrasonic detection part, and an external force is applied to press the puncture needle to inspect and / or treat the breast of the subject. At present, an ultrasonic probe is used to first detect the lesion area, and then the puncture needle is used to puncture the lesion area, but this has certain disadvantages. The puncture needle cannot accurately locate the puncture site and needs to be assisted by other medical devices, or an ultrasonic probe is used to locate the grid area in the lesion area, but such positioning is often complicated and time-consuming, which is not conducive to the rapid examination of the subject. This structure is provided with a positioning hole in the middle of the ultrasonic detection part. During use, the detection surface of the lower end of the ultrasonic probe detects the lesion area of ​​the subject and displays it on the background computer. The position of the lower end of the ultrasonic detection part corresponding to the lower end of the positioning hole is the detection blind area. The detection blind area is equivalent to the lesion puncture point to be punctured. Therefore, with the movement and detection of the ultrasonic detection part, the puncture point can be directly located by the detection blind area. In the next step, the puncture needle can be pressed by external force to achieve accurate and effective puncture treatment of the puncture point by piercing the skin. The above-mentioned positioning hole is set in the middle of the above-mentioned ultrasonic detection part, and it is a cylindrical hole. This design enables the ultrasonic detection part to detect the position of the detection blind area no matter how it moves. The design is reasonable and conducive to the medical staff to quickly locate the puncture point. At the same time, the cylindrical hole design matches the puncture needle, which is conducive to the movement of the puncture needle.

[0025] Preferably, a xiphoid protrusion is provided on the rigid frame, and when the subject undergoes breast scanning, the xiphoid position of the subject's body corresponds to and is in close contact with the xiphoid protrusion.

[0026] Preferably, a suprasternal fossa protrusion is provided on the rigid frame, and when the subject undergoes breast scanning, the suprasternal fossa position of the subject's body corresponds to and is in close contact with the suprasternal fossa protrusion.

[0027] Preferably, when the palpation detection unit and the ultrasonic detection unit are independently arranged and not together, the device further comprises a selection member, wherein the selection member fixes the palpation detection unit and the ultrasonic detection unit, is carried at the end of the mechanical carrier, and is rotated so that one of the palpation detection unit and the ultrasonic detection unit faces the through hole of the diagnosis and treatment bed. When the palpation examination of the subject's breast is completed, the selection member can be used to rotate to the ultrasonic detection unit so that the ultrasonic detection unit faces the through hole of the diagnosis and treatment bed, and an ultrasonic examination is performed on the subject's breast. An ultrasonic treatment unit can also be fixedly mounted on the selection member for treating the subject's breast tumor. Of course, a breast far-infrared inspection unit can also be fixedly mounted on the selection member, which is mainly used for early detection and differentiation of mastitis, breast hyperplasia, breast fibroids, breast cancer, etc.

[0028] (III) Beneficial effects

[0029] The breast diagnosis and treatment equipment provided by the present invention adopts a CMUT linear array palpation detection part. First, the CMUT linear array form is easier to produce and has advantages over the area array in terms of manufacturing process. Second, by uniformly applying pressure and displacement on the subject's breast by the CMUT linear array, continuous breast tissue pressure data of the subject can be obtained. By integrating and splicing the continuous pressure data during the contact pressure process, a complete image of the breast examination is formed. Compared with the area array, the amount of palpation data integration is less and the background calculation amount is smaller.

[0030] The ultrasonic treatment part provided by the present invention is composed of a CMUT treatment transducer. The emitted ultrasonic waves converge at one point to form the focus of the CMUT treatment transducer, which is used to act on the breast lesions of the subject. The cavitation effect of the ultrasonic waves is used to loosen the breast lesions or curds, and the focused energy is used for precise positioning treatment of the tumor.

[0031] The adjustment member provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection unit on the subject's breast, and uses a mechanical carrier to keep the palpation detection unit pressed on the subject's breast with a relatively consistent pressure during the pressure palpation inspection, so as to ensure the accuracy of the palpation inspection data. The adjustment member includes a displacement sensor, which collects the distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasonic waves emitted by the ultrasonic treatment unit are focused to perform ultrasonic treatment on the subject's breast tumor. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 : A schematic diagram of the three-dimensional structure of the first embodiment of the breast diagnosis and treatment device of the present invention;

[0033] Figure 2 : A schematic diagram of the partial three-dimensional structure of the first embodiment of the breast diagnosis and treatment device of the present invention when the subject is in use;

[0034] Figure 3 : A schematic diagram of the three-dimensional structure of the palpation detection unit, the ultrasonic detection unit, and the ultrasonic treatment unit in the first embodiment of the breast diagnosis and treatment device of the present invention;

[0035] Figure 4 : A schematic diagram of the three-dimensional structure of the fixing part in the first embodiment of the breast diagnosis and treatment device of the present invention;

[0036] Figure 5 : A schematic diagram of the process of controlling the palpation detection unit, the ultrasonic detection unit, and the ultrasonic treatment unit by the mechanical carrier and the adjustment member in the first embodiment of the breast diagnosis and treatment device of the present invention;

[0037] Figure 6 : A schematic diagram of the three-dimensional structure of the second embodiment of the breast diagnosis and treatment device of the present invention;

[0038] Figure 7 : A front view structural diagram of a second embodiment of the breast diagnosis and treatment device of the present invention;

[0039] Figure 8 : A schematic diagram of the three-dimensional structure of the palpation detection unit, the ultrasonic detection unit, and the ultrasonic treatment unit on the selection component in the second embodiment of the breast diagnosis and treatment equipment of the present invention;

[0040] Fig. 9 : Schematic diagram of the cross-sectional structure of the ultrasonic detection part in the second embodiment of the breast diagnosis and treatment equipment of the present invention;

[0041] Fig.10 : A schematic diagram of the three-dimensional structure of the fixing part in the second embodiment of the breast diagnosis and treatment device of the present invention;

[0042] In the figure: 1. examinee; 11. breast; 2. diagnosis and treatment bed; 21. prone bed board; 211. through hole; 22. bracket; 23. base; 24. pulley; 3. fixing part; 30. buckle; 31. rigid frame; 311. suprasternal fossa protrusion; 312. xiphoid protrusion; 313. through area; 32. elastic membrane; 321. elastic surface; 321a. mark; 321b. small round hole; 4. diagnosis and treatment body; 41. Palpation detection unit; 42. Ultrasonic detection unit; 421. Positioning hole; 43. Mechanical carrier; 431. Lifting component; 432. Translation component; 433. Controller; 434. Rotating component; 435. Foot; 44. Adjustment component; 441. Pressure sensor; 442. Displacement sensor; 45. Selection component; 451. Clamp; 46. Breast far-infrared inspection unit; 47. Cable; 48. Ultrasonic treatment unit; 5. Puncture needle. DETAILED DESCRIPTION

[0043] The specific implementation of the present invention is further described in detail below in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0044] In the description of the present invention, it should be noted that, unless otherwise defined, all technical and scientific terms herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. The terms "first", "second", etc. used herein do not indicate any order, quantity or importance, but are only used to distinguish one element from another. Moreover, "one" or "an" does not indicate a limitation of quantity, but indicates the existence of one related item.

[0045] Embodiment 1:

[0046] In order to solve the technical problem of fully automatic detection and treatment of the breast 11 of the examinee 1, the existing palpation equipment and ultrasound equipment have technical problems of detection speed and detection accuracy due to human factors. Figure 1As shown, the present invention provides a breast diagnosis and treatment device, which is specifically divided into three main parts, including: a diagnosis and treatment bed 2 for placing the examinee 1 in a prone position, a fixing part 3 for shaping and constraining the breast 11 of the examinee 1 in the prone position, and a diagnosis and treatment body 4 for detecting and treating the breast 11 of the examinee 1. The diagnosis and treatment bed 2 specifically includes a prone bed board 21, a bracket 22, a base 23 and a pulley 24. The prone bed board 21 is made of wood or metal, and a through hole 211 for the breast 11 of the examinee 1 to pass through is provided on the prone bed board 21. The bracket 22 is connected to the prone bed board 21, used to support the prone bed board 21, and forms a ground clearance with the ground. The base 23 is connected to the bracket 22, and a pulley 24 is provided at the bottom of the base 23. The diagnosis and treatment bed 2 can be moved arbitrarily through the pulley 24. In order to adjust the ground clearance between the prone bed board 21 and the ground, a lifting mechanism is provided inside the bracket 22, and the lifting mechanism includes a lifting rod, a rack fixed on one side of the lifting rod, a gear meshing with the rack, and a servo motor driving the gear to rotate. The lifting mechanism allows the length of the bracket 22 to be extended and retracted to adjust the ground clearance between the prone bed board 21 and the ground.

[0047] The invention aims to solve the technical problem that when the examinee 1 undergoes breast examination, the shape of the breast 11 changes too much in the prone position, which affects the examination effect of the scanning probe. Figure 4 As shown, a fixing part 3 is mounted on the through hole 211 of the diagnosis and treatment bed 2. The fixing part 3 uses a rigid frame 31 to support an elastic membrane 32. The elastic membrane 32 can be deformed to fit and cover the breast 11 to be detected, elastically constrain the breast 11 of the examinee 1, and shape and fix the breast 11 of the examinee 1 into a form that is conducive to breast diagnosis and treatment. The fixing part 3 is a disposable medical consumable product. The rigid frame 31 is made of medical plastic material and is in a flat plate shape as a whole. A through area 313 is provided on it. The through area 313 is rectangular, allowing the breast 11 and accessory breast of the examinee 1 to pass through in a conformable manner. A buckle 30 is provided on the edge of the rigid frame 31, which is detachably connected to the diagnosis and treatment bed 2 by using the buckle 30, so that the lower surface of the rigid frame 31 is tightly connected to the diagnosis and treatment bed 2. The elastic membrane 32 is made of fiber filaments with a denier not greater than 50D and polyester filaments interwoven by a knitting machine. The elastic membrane 32 is stretched open by the rigid frame 31. The outer edge of the elastic membrane 32 is fixedly connected to the rigid frame 31. Under the tensile force of the rigid frame 31, the elastic membrane 32 is flattened and can withstand a certain force applied thereto without significant stretching and deformation. The portion of the elastic membrane 32 covering the through area 313 is an elastic surface 321. When the subject 1 is in a prone position, the breast 11 to be scanned is attached to and pressed against the elastic surface 321, and the skin around the breast 11 is attached to the upper surface of the rigid frame 31. At this time, the elastic surface 321 is deformed to shape and fix the breast 11 of the subject 1. The elastic membrane 32 has the advantages of being soft and elastic, and has no adverse effects on palpation imaging and ultrasound angiography.

[0048] like Figure 2 As shown, in order to perform fully automatic palpation detection on the breast 11 of the examinee 1, a diagnosis and treatment body 4 is provided at the lower part of the prone bed plate 21 of the diagnosis and treatment bed 2, and the diagnosis and treatment body 4 is arranged opposite to the through hole 211 of the diagnosis and treatment bed 2. The lower part of the diagnosis and treatment body 4 is provided with a foot 435 for being stably installed at the lower part of the diagnosis and treatment bed 2. The diagnosis and treatment body 4 includes a mechanical carrier 43, a palpation detection unit 41, and an adjustment member 44. The mechanical carrier 43 includes a lifting component 431, a translation component 432, and a rotation component 434. The lifting component 431 is used to move the palpation detection unit 41 in the vertical Z-axis direction, the translation component 432 is used to move the palpation detection unit 41 in the horizontal X-axis and Y-axis directions, and the rotation component 434 controls the palpation detection unit 41 of the diagnosis and treatment body 4 to diagnose the breast 11 of the examinee 1 at a certain angle with the horizontal plane, so that the palpation detection unit 41 moves conformably along the arc surface of the breast 11 of the examinee 1. Specifically, the lifting component 431 is used for up and down displacement in the Z-axis direction, and includes a lifting rod, a rack fixed on one side of the lifting rod, a gear meshing with the rack, and a first servo motor driving the gear to rotate. The lifting rod is slidably connected to the translation component 432, and its upper end is fixedly connected to the adjustment member 44. The first servo motor is connected to the controller 433. The translation component 432 is used for displacement in the X-axis and Y-axis directions, and includes a translation slide through which the lifting rod slides, a translation base slidably connected to the translation slide, two pulleys arranged in parallel on the translation base, and a second servo motor driving any one of the pulleys to rotate. The translation slide moves along the length direction of the translation base, and the translation slide moves along its own width direction. The second servo motor is connected to the controller 433.

[0049] like Figure 5 As shown, the mechanical carrier 43 drives the palpation detection part 41 to move, and utilizes the pressure sensor 441 of the adjustment member 44 to examine the entire breast 11 of the examinee 1 in a sliding manner from left to right or from top to bottom with relatively consistent pressure during the pressure palpation examination of the palpation detection part 41. The adjustment member 44 is connected to the controller 433 of the mechanical carrier 43, and changes the pressure between the palpation detection part 41 and the breast 11 of the examinee 1 by being placed on the mechanical carrier 43. The pressure sensor 441 is installed on one side of the palpation detection part 41, and keeps in continuous contact with the breast 11 of the examinee 1, and feeds back the pressure data collected by the pressure sensor 441 at the contact position, and sends the collected pressure data to the controller 433, and controls the lifting component 431 based on the pressure data, so as to change the pressure between the palpation detection part 41 and the surface of the breast 11 of the examinee 1 to be consistent. As shown Figure 3As shown, an ultrasonic detection unit 42 is provided on one side adjacent to the palpation detection unit 41, and the two are arranged together so as to facilitate switching for detection at any time, and a pressure sensor 441 is used to maintain continuous contact with the breast 11 of the examinee 1, and the pressure data collected by the pressure sensor 441 at the contact position is fed back, and the collected pressure data is sent to the controller 433, and the lifting component 431 is controlled based on the pressure data, and the pressure between the ultrasonic detection unit 42 and the surface of the breast 11 of the examinee 1 is changed to be consistent, and the ultrasonic detection unit 42 performs ultrasonic examination on the breast 11 of the examinee 1, distinguishes whether the lesion is cystic or solid, and realizes imaging of the depth of the lesion in the breast and the three-dimensional shape of the mass. The device also includes an ultrasonic treatment unit 48, and the ultrasonic treatment unit 48 uses the ultrasonic waves emitted by the CMUT treatment transducer to converge at one point to form the focus of the CMUT treatment transducer, and acts on the breast tumor of the examinee 1, and uses the cavitation effect of the ultrasonic wave to liquefy the breast tumor. The mechanical carrier 43 can drive the ultrasonic treatment part 48 to move, and the adjustment member 44 includes a displacement sensor 442, which detects the distance data between the ultrasonic treatment part 48 and the surface of the breast 11 of the subject 1, and sends the collected distance data to the controller 433, and controls the lifting component 431 based on the distance data to change and adjust the distance between the ultrasonic treatment part 48 and the breast 11 of the subject 1, so that the ultrasonic waves emitted by the ultrasonic treatment part 48 converge at one point to form the focus of the treatment transducer, and focus on the breast tumor of the subject 1, so as to detect or treat the breast tumor of the subject 1. The palpation detection part 41, the ultrasonic detection part 42, the ultrasonic treatment part 48, the pressure sensor 441, and the displacement sensor 442 are carried together, which helps to connect the cable 47 together to transmit the collected data to the external device.

[0050] Embodiment 2:

[0051] like Figure 6 , Figure 7 As shown, the present invention also provides another breast diagnosis and treatment device, which is slightly different from Example 1. The difference lies in the mechanical carrier 43 of the diagnosis and treatment body 4, which is in the form of a six-axis mechanical arm, including a lifting platform that can be relatively movable up and down and is horizontally arranged, the lifting platform is equipped with a lifting drive component, the upper surface of the lifting platform is screwed with a mechanical arm mounting seat, the upper end of the mechanical arm mounting seat is screwed with a mechanical hand, and the upper end of the mechanical hand is equipped with an adjustment member 44 and a selection member 45, the selection member 45 is provided with a clamp 451, and the clamp 451 fixes the independent palpation detection unit 41, ultrasonic detection unit 42, ultrasonic treatment unit 48, etc. The mechanical carrier 43 controls the palpation detection unit 41 and the ultrasonic detection unit 42 to diagnose and treat the breast 11 of the subject 1 at a certain angle to the horizontal plane.

[0052] like Figure 8As shown, the selection member 45 is mounted at the end of the mechanical carrier 43, and rotates to make one of the palpation detection unit 41, the ultrasonic detection unit 42, and the ultrasonic treatment unit 48 face the through hole 211 of the diagnosis and treatment bed 2. When the breast 11 of the examinee 1 is palpated, the selection member 45 can be used to rotate to the ultrasonic detection unit 42, so that the ultrasonic detection unit 42 faces the through hole 211 of the diagnosis and treatment bed 2, and the breast 11 of the examinee 1 is ultrasonically examined. The selection member 45 can also be fixed with a breast far-infrared inspection unit 46, which is mainly used for early and differential mastitis, breast hyperplasia, breast fibroids, breast cancer, etc. The breast far-infrared inspection requires the examinee 1 to take off his top and expose his breast 11. The doctor moves the breast far-infrared inspection unit 46 along the breasts 11 on both sides to see if there are lesions in the breasts 11 under the X-ray. The selection member 45 can also be fixed with a microwave inspection unit, and non-contact thermal therapy is performed on the breast 11 using microwaves. The palpation detection unit 41, the ultrasonic detection unit 42, the ultrasonic treatment unit 48 and the breast far-infrared inspection unit 46 are connected to the palpation detection unit 41. The pressure sensor 441 of the adjustment member 44 is provided on the adjacent side of the palpation detection unit 41. During the pressure palpation inspection process, the palpation detection unit 41 inspects the entire breast 11 of the examinee 1 in a sliding manner from left to right or from top to bottom with relatively consistent pressure. The adjustment member 44 is connected to the controller 433 of the mechanical carrier 43, and the pressure between the palpation detection unit 41 and the breast 11 of the examinee 1 is changed by being placed on the mechanical carrier 43. The pressure sensor 441 sends the collected pressure data to the controller 433, and controls the mechanical arm based on the pressure data to change and adjust the pressure between the palpation detection unit 41 and the surface of the breast 11 of the examinee 1 in real time to keep it consistent. The pressure sensor 441 of the adjustment member 44 is also provided on the adjacent side of the ultrasonic detection unit 42. The mechanical carrier 43 can drive the ultrasonic treatment part 48 to move, and the adjustment component 44 includes a displacement sensor 442, which detects the distance data between the ultrasonic treatment part 48 and the surface of the breast 11 of the subject 1, and sends the collected distance data to the controller 433, and controls the mechanical arm based on the distance data to change and adjust the distance between the ultrasonic treatment part 48 and the breast 11 of the subject 1 in real time, so that the ultrasonic waves emitted by the ultrasonic treatment part 48 converge at one point to form the focus of the treatment transducer, and the breast tumor of the subject 1 is treated by focusing.

[0053] like Fig. 9As shown, the device also includes a puncture needle 5, and a positioning hole 421 is provided in the middle position of the ultrasonic detection part 42. The lower end of the puncture needle 5 extends into the positioning hole 421, and the upper end thereof is exposed outside the ultrasonic detection part 42. External force is applied to press the puncture needle 5 to inspect and / or treat the breast 11 of the subject 1. During use, the detection surface at the lower end of the ultrasonic detection part 42 detects the lesion area of ​​the subject 1 and displays it on the background computer. The position at the lower end of the corresponding positioning hole 421 is the detection blind area, which is equivalent to the puncture point of the lesion to be punctured. Therefore, with the movement detection of the ultrasonic detection part 42, the puncture point can be directly located through the detection blind area. In the next step, by pressing the puncture needle 5 with external force, the puncture needle 5 can pierce the skin to perform accurate and effective puncture treatment on the puncture point. The positioning hole 421 is a cylindrical hole. This design enables the ultrasonic detection unit 42 to detect the position of the detection blind area no matter how it moves. The design is reasonable and helps medical staff to quickly locate the puncture point. At the same time, the cylindrical hole design matches the puncture needle 5, which is conducive to the movement and puncture of the puncture needle 5.

[0054] like Fig.10 As shown, in order to further solve the technical problem of relative position alignment between the breast 11 and the elastic surface 321, the rigid frame 31 is provided with a suprasternal fossa protrusion 311 and a xiphoid process protrusion 312. When the subject 1 undergoes breast scanning, the suprasternal fossa position of the subject 1 corresponds to and is in close contact with the suprasternal fossa protrusion 311, and the xiphoid process position corresponds to and is in close contact with the xiphoid process protrusion 312, thereby ensuring that the breast 11 is fixed in the correct position of the elastic surface 321. In order to solve the technical problem of relative position alignment between the breast 11 and the elastic surface 321, and to prevent the breast 11 from being deflected and affecting the breast scan when the elastic surface 321 restrains the breast 11 from bottom to top, a target-shaped mark 321a is provided on the elastic membrane 32. The mark 321a is composed of a plurality of annular visual marks, and the plurality of annular visual marks have different outer diameters and are mutually nested to form a target shape. When the human body is lying prone, the breast 11 is aimed at the target-shaped mark 321a to fix the breast 11 in the correct position of the elastic surface 321. In order to further ensure the correct relative position between the breast 11 and the elastic surface 321, a small round hole 321b is provided on the elastic surface 321, and the nipple of the human breast 11 passes through the small round hole 321b, so that the elastic surface 321 is closely attached to the scanned breast 11, forming a close contact between the elastic surface 321 and the skin of the breast 11.

[0055] The present invention solves the technical problem of fully automatic detection and treatment of the breast 11 of the examinee 1, the technical problem of the detection rate of the existing palpation equipment and ultrasound equipment due to human factors, and the technical problem that the existing ultrasound equipment cannot automatically treat the breast.

[0056] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A breast diagnosis and treatment device, comprising a diagnosis and treatment bed (2) for placing a subject (1) in a prone position, the diagnosis and treatment bed (2) being provided with a through hole (211) for allowing the subject's (1) breast (11) to pass through, a fixing portion (3) being carried on the through hole (211), the fixing portion (3) supporting an elastic membrane (32) by means of a rigid frame (31), the elastic membrane (32) being deformable to fit and cover the breast (11) to be detected, elastically constraining the subject's (1) breast (11), and shaping and fixing the subject's (1) breast (11) into a shape that is conducive to breast diagnosis and treatment, characterized in that: Also includes: A diagnosis and treatment body (4) is arranged around a breast (11) of the subject (1) hanging down from a through hole (211) of the diagnosis and treatment bed (2) when the subject (1) is in a prone position on the diagnosis and treatment bed (2), and the diagnosis and treatment body (4) is provided with at least a palpation detection unit (41), and the palpation detection unit (41) collects pressure distribution data of a lesion in the breast (11) of the subject (1) by using a CMUT linear array in a moving touch pressure manner; A mechanical carrier (43), the mechanical carrier (43) being arranged at the bottom of the diagnosis and treatment bed (2), driving the diagnosis and treatment body (4) to move in position so as to detect the breast (11) of the subject (1), the mechanical carrier (43) comprising a controller (433) for controlling the diagnosis and treatment body (4) to move in vertical and horizontal directions and to conform to the curved surface of the breast (11) of the subject (1); an adjusting member (44), the adjusting member (44) being connected to a controller (433) and being placed on the mechanical carrier (43) to change and adjust the pressure between the diagnosis and treatment body (4) and the breast (11) of the subject (1); The rigid frame (31) of the fixing portion (3) is provided with a through area (313) conforming to the base of the breast (11); after the breast (11) passes through the through area (313), the skin around the breast (11) adheres to the upper surface of the rigid frame (31); the elastic membrane (32) is fixed to the rigid frame (31) to cover at least a portion of the through area (313); the elastic membrane (32) is stretched open by the rigid frame (31) to provide an elastic surface (321); the elastic surface (321) can be deformed to fit and cover the breast (11) to be scanned; The rigid frame (31) is provided with a xiphoid protrusion (312). When the subject (1) undergoes breast scanning, the xiphoid position of the subject's (1) body corresponds to and is in close contact with the xiphoid protrusion (312).

2. The breast diagnosis and treatment equipment according to claim 1, characterized in that: The CMUT linear array used by the palpation detection unit (41) is a linear array composed of 1 x 16 capacitive micromechanical ultrasonic sensor functional units, and is used to obtain a pressure distribution image of a lesion in the breast (11).

3. The breast diagnosis and treatment equipment according to claim 1, characterized in that: The diagnosis and treatment body (4) is also provided with an ultrasonic detection unit (42), the ultrasonic detection unit (42) using a CMUT linear array as an integrated ultrasonic transceiver and located on a side adjacent to the palpation detection unit (41), the ultrasonic detection unit (42) being used to perform ultrasonic examination on the breast (11) of the subject (1).

4. The breast diagnosis and treatment device according to any one of claims 1 to 3, characterized in that: The adjustment member (44) comprises a pressure sensor (441), the pressure sensor (441) being in continuous contact with the breast (11) of the subject (1), feeding back pressure data collected by the pressure sensor (441) at the contact position, and controlling the adjustment member (44) to change and adjust the pressure between the diagnosis and treatment body (4) and the surface of the breast (11) of the subject (1) based on the pressure data.

5. The breast diagnosis and treatment equipment according to claim 1, characterized in that: The diagnosis and treatment body (4) is also provided with an ultrasonic treatment unit (48), which uses the ultrasonic waves emitted by the CMUT treatment transducer to converge at a point to form a focus of the CMUT treatment transducer, and is used to act on the breast lesion of the subject (1), using the cavitation effect of the ultrasonic wave to loosen the breast lesion or milk curd, and using the focused energy to perform precise positioning treatment of the tumor.

6. The breast diagnosis and treatment equipment according to claim 5, characterized in that: The adjustment member (44) includes a displacement sensor (442) which measures distance data from a breast (11) of a subject (1) and changes and adjusts the distance between an ultrasonic treatment section (48) of the diagnosis and treatment body (4) and a surface of the breast (11) of the subject (1) based on the distance data.

7. The breast diagnosis and treatment equipment according to claim 1, characterized in that: The mechanical carrier (43) comprises a lifting component (431), a translation component (432) and a rotation component (434), wherein the lifting component (431) is used to move the palpation detection part (41) of the diagnosis and treatment body (4) in a vertical direction; the translation component (432) is used to move the palpation detection part (41) of the diagnosis and treatment body (4) in a horizontal direction; and the rotation component (434) controls the palpation detection part (41) of the diagnosis and treatment body (4) to form a certain angle with the horizontal plane to diagnose the breast (11) of the examinee (1), so that the diagnosis and treatment body (4) moves conformably along the arc-shaped surface of the breast (11) of the examinee (1).

8. The breast diagnosis and treatment equipment according to claim 3, characterized in that: It also includes a puncture needle (5), a positioning hole (421) is provided in the middle of the ultrasonic detection part (42), the lower end of the puncture needle (5) extends into the positioning hole (421), and the upper end of the puncture needle (5) is exposed outside the ultrasonic detection part (42), and an external force is applied to press the puncture needle (5) to examine and / or treat the breast (11) of the subject (1).

9. The breast diagnosis and treatment equipment according to claim 1, characterized in that: The rigid frame (31) is provided with a suprasternal fossa protrusion (311). When the subject (1) undergoes breast scanning, the suprasternal fossa position of the subject (1) corresponds to and is in close contact with the suprasternal fossa protrusion (311).

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