Transvaginal ultrasound probe with pressure assist device

Abstract

This invention provides a transvaginal ultrasound probe equipped with a pressure assist device that enables standardized control of pressure depth and force in cervical elastography, thereby improving the objectivity and reproducibility of manual pressure operations. [Solution] The device comprises a probe body and a pressure assist device that is detachably attached to the outer circumference of its columnar handle portion 12. The pressure assist device includes a fixed base 1, a handheld support assembly, a depth adjustment mechanism, and a pressure state display mechanism. A finger rest recess is provided on the back surface of the handle portion of the handheld support assembly to guide the direction of force when gripping. The depth adjustment mechanism allows the insertion depth of the probe to be set in advance by a guide slide rod 9 and a limit ring 8. The pressure state display mechanism converts the pressurizing force into a visible displacement scale by an elastic compensation spring and a displacement transmission rod. Conventionally, manual pressurizing operations using transvaginal ultrasound probes have been problematic because they depend on the operator's subjectivity and have low reproducibility of the pressurizing direction and force.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and specifically relates to a transvaginal ultrasound probe equipped with a pressurization assist device.

Background Art

[0002] In the field of clinical medicine, ultrasonic examination technology has become an important means for the diagnosis of gynecological diseases and the prediction of preterm labor due to its advantages such as intuitiveness, non-invasiveness, and reproducibility. Among them, transvaginal ultrasound can clearly depict the anatomical form of the cervical canal, and by measuring important indicators such as the length of the cervical canal and the width of the internal os of the cervical canal, it provides a scientific basis for clinical practice. With the development of medical imaging technology, ultrasonic elastography technology has gradually been applied to the evaluation of the physical properties of cervical tissues. By identifying the dynamic changes in cervical hardness, the prediction accuracy of spontaneous preterm labor risk has been further improved.

[0003] In the actual operation process of ultrasonic elastography, it is usually necessary to apply pressure to the target tissue with an ultrasonic probe to obtain elastic parameters such as the strain ratio. Currently, in clinical practice, the method of manually gripping and pressurizing the probe by the operator is widely adopted. Manual pressure causes deformation in the cervical tissue, and based on this, the device collects and calculates relevant elastic data, which is used for the auxiliary determination of cervical maturity.

[0004] However, existing transvaginal ultrasound probes, when performing manual pressurization measurements, prioritize the physical structure that meets the requirements for insertion and imaging. Due to the lack of a dedicated gripping aid during the pressurization process, the direction and force of the pressure applied by the operator are easily constrained by individual gripping habits and are highly subjective. This lack of uniformity in pressurization methods affects the measurement stability of elastic parameters to some extent, leading to variations in parameter reproducibility between different operators and making it difficult to achieve precise control of pressurization intensity. Existing studies indicate that while cervical elastography technology is already widely applied to predict and evaluate spontaneous preterm birth, the technology remains constrained by the experience level of both the equipment and the operator in actual operation, requiring the performance of experienced technicians. Furthermore, the acquisition of elastic parameters is subject to certain errors due to the influence of multiple factors, including individual differences, cervical morphology, measurement site, and probe pressure applied by the operator.

[0005] Therefore, existing structures have limitations in ensuring the smoothness of manual pressurization and consistency of force generation, which affects the degree of standardization of cervical elasticity test results and the reliability of the data. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] This invention addresses the shortcomings of the above-mentioned prior art by providing a transvaginal ultrasound probe equipped with a pressure assist device. [Means for solving the problem]

[0007] The technical solution adopted in this invention is as follows:

[0008] A transvaginal ultrasound probe equipped with a pressure assist device, comprising a probe body having a detection end and a columnar handle portion, and further comprising a pressure assist device attached to the outer circumference of the columnar handle portion, the pressure assist device comprising a fixed base, a handheld support assembly, a depth adjustment mechanism and a pressure state display mechanism, The fixed base grips the outer circumference of the columnar handle portion, The handheld support assembly includes a left wing plate and a right wing plate provided symmetrically on both sides of the fixed base, and each of the left wing plate and the right wing plate includes a support rod and a handle portion connected to the outside of the support rod, and the back surface of the handle portion is provided with a plurality of finger rest recesses. The depth adjustment mechanism includes a guide slide rod and a limit ring, the guide slide rod being fixed to the fixed base and extending toward the detection end, and the limit ring being slidably fitted onto the guide slide rod. The pressure state display mechanism includes an elastic compensating spring, a displacement transmission rod, and an observation window. A cavity is formed inside the support rod, the elastic compensating spring is housed within the cavity, one end of the displacement transmission rod abuts against the elastic compensating spring, and a window-shaped scale plate is connected to the other end. The observation window is provided on the side of the handle portion.

[0009] Specifically, the fixed base is constructed by butting together a first semi-annular body and a second semi-annular body, the first semi-annular body and the second semi-annular body are closed by a tightening handle to form a cylindrical containment cavity that grips the columnar handle, an elastic friction pad is provided on the inner wall of the cylindrical containment cavity, an annular positioning groove is provided on the outer circumferential surface of the columnar handle, and an annular projection is provided on the elastic friction pad that fits into the annular positioning groove.

[0010] Specifically, the radius of curvature of the finger rest recess is 10 mm to 15 mm, the distance between the centers of two adjacent finger rest recesses is 20 mm, and the depth of the finger rest recess gradually decreases from top to bottom, with the uppermost finger rest recess being 8 mm deep and the lowermost finger rest recess being 4 mm deep.

[0011] The edge of the observation window is provided with multiple color regions representing different pressure levels. [Effects of the Invention]

[0012] This invention provides the following beneficial effects.

[0013] This invention features a first and second semi-annular body of the fixed base that, after closing, form a cylindrical cavity. Combined with the tightening action of the tightening handle, this ensures secure attachment and rapid detachment of the pressurizing auxiliary device to the outer circumference of the columnar handle of the probe body. Simultaneously, the axial positioning fit between the annular projection on the elastic friction pad and the annular positioning groove on the probe surface effectively prevents axial displacement of the device during use, meeting the requirements for frequent disinfection and replacement and repositioning accuracy in clinical settings, and enhancing the overall reliability of the device.

[0014] This invention provides a left wing plate and a right wing plate, including a support rod and a handle, symmetrically around the outer circumference of a fixed base, and provides four finger-grip recesses on the back surface of the handle with a gradient distribution of depth. By using an ergonomically conforming arc-shaped curved surface, it guides the operator's fingers to a predetermined force-receiving position, concentrates the force from the hand in a specific direction, eliminates the interference of multidirectional force components caused by the voluntariness of posture in conventional cylindrical gripping methods, and improves directional stability and force generation consistency during manual pressure application.

[0015] This invention, through the cooperation of a guide slide rod and a limit ring with a tightening knob in the depth adjustment mechanism, allows the operator to pre-set and lock the maximum probe insertion depth based on the individual anatomical differences of the subject, ensuring accurate reproduction of the probe-cervical contact position in multiple measurements. Simultaneously, the pressure state display mechanism linearly converts the pressure applied by the hand into axial movement of the displacement transmission rod using an elastic compensation spring within the cavity of the support rod, providing intuitive quantitative visual feedback through the color area of ​​the observation window edge, thereby enabling standardized control of the pressure intensity and effectively filtering out minute vibrations of the hand. This reduces measurement errors introduced by fluctuations in manual pressure during the collection process of elastic parameters such as the cervical elasticity ratio, cervical internal / external strain ratio, and hardness ratio, improving reproducibility and data reliability in single measurements and multiple follow-up observations of the above elastic parameters, and providing a more stable and reliable quantitative data base for subsequent construction of preterm birth prediction models based on cervical multimodal parameters. [Brief explanation of the drawing]

[0016] [Figure 1] Figure 1 is a schematic diagram showing the overall structure of the present invention. [Figure 2] Figure 2 is a schematic diagram showing the structure of a pressure assist device. [Figure 3] Figure 3 is a schematic diagram showing the structure of the fixed base. [Figure 4] Figure 4 shows the local cross-sectional structure of the pressure state display mechanism. [Modes for carrying out the invention]

[0017] The embodiments of the present invention will be described below with reference to the drawings. These embodiments are provided for the purpose of clearly and completely illustrating the present invention and do not limit its scope.

[0018] Referring to Figures 1 to 4, the present invention includes a probe body and a pressurizing auxiliary device provided on the outside of the probe body. Specifically, the pressurizing auxiliary device comprises a fixed base 1, a handheld support assembly, a depth adjustment mechanism, and a pressure state display mechanism, while the probe body includes a detection end 11, a columnar handle portion 12, and a tail cable. The pressurizing auxiliary device is mounted on the outer circumference of the columnar handle portion 12 via the fixed base 1. An annular positioning groove 13 is pre-formed around the surface of the columnar handle portion, and an annular projection that aligns with the annular positioning groove is provided on the elastic friction pad of the inner wall of the fixed base 1, thereby achieving precise axial positioning between the pressurizing auxiliary device and the probe.

[0019] The fixed base 1 has a two-part ring structure and includes a first semi-annular body 2 and a second semi-annular body 3. The first semi-annular body 2 and the second semi-annular body 3 are closed together by a tightening handle 4, and after closing, the first semi-annular body 2 and the second semi-annular body 3 form a cylindrical containment cavity that matches the outer diameter of the ultrasonic probe gripping part. A single elastic friction pad is provided on the inner wall of the cylindrical containment cavity. Exhaust grooves are formed on the surface of the elastic friction pad, intersecting vertically and horizontally. The installation of exhaust grooves removes air between the fixed base 1 and the probe housing and increases the radial pressure between them.

[0020] The handheld support assembly is symmetrically attached to the outer peripheral side of the fixed base 1 and includes a left wing plate 5 and a right wing plate 6. Both the left wing plate 5 and the right wing plate 6 are composed of an inner support rod and an outer handle part 7. Four finger-hooking recesses are provided at equal intervals along the longitudinal direction on the dorsal surface of the handle part 7. The radius of curvature of the finger-hooking recesses is between 10 mm and 15 mm, and the center-to-center distance between two adjacent finger-hooking recesses is 20 mm. The depth of the finger-hooking recesses gradually decreases from top to bottom. The depth of the uppermost finger-hooking recess is 8 mm, and the depth of the lowermost finger-hooking recess is 4 mm. Anti-slip particles are provided on the inner surface of each finger-hooking recess. The material of the handle part 7 is a hard nylon inner core coated with thermoplastic elastomer soft rubber as the outer layer to achieve stability during the gripping process.

[0021] The depth adjustment mechanism is attached to the front end of the fixed base 1 and includes a guide slide rod 9 and a limit ring 8 with a tightening knob. One end of the guide slide rod 9 is fixed to the front end face of the fixed base 1, and the other end extends parallel to the detection end direction of the ultrasonic probe. The total length of the guide slide rod 9 is 200 mm. The limit ring 8 is slidably externally fitted around the outer periphery of the guide slide rod 9 through a sliding hole at the central part and is locked by the tightening knob. The annular surface of the limit ring 8 is perpendicular to the axis of the ultrasonic probe. Length graduation lines with an accuracy of 1 mm are engraved on the surface of the guide slide rod 9, and the graduation range extends from 0 to 200 mm and is used to define the maximum depth that the probe enters into the vagina. An annular flexible pad is provided on the surface of the limit ring 8 facing the detection end side. The flexible pad is made of foamed polyurethane material and produces a buffering effect when contacting the external tissue of the human body.

[0022] The pressure state display mechanism is installed inside the handheld support assembly and includes an elastic compensation spring, a displacement transmission rod, and a window-shaped scale plate. A cylindrical cavity with a diameter of 10 mm is formed inside the support rod, and the elastic compensation spring is housed within the cylindrical cavity. The wire diameter of the elastic compensation spring is 1.2 mm, the outer diameter is 8 mm, and the effective number of turns is 10. One end of the displacement transmission rod abuts against the tip of the elastic compensation spring, and the other end is connected to the window-shaped scale plate. A transparent observation window 10 is provided on the side surface of the handle portion 7. A color area representing the pressure level is marked on the edge of the observation window 10, and the color area is composed of three color blocks: green, yellow, and red. The stiffness coefficient of the elastic compensation spring is preset based on the standard pressure range required for cervical elasticity measurement, and visual feedback of the magnitude of the applied pressure is realized through the axial displacement generated on the support rod when the handle portion 7 is stressed.

[0023] In this embodiment, an angle adjustment dial is provided at the connection points between the left wing plate 5 and the right wing plate 6 and the fixed base 1. The angle adjustment dial includes a toothed groove base and a convex-toothed rotating shaft. By loosening the fixing bolt at the central part, the inclination angle adjustment of the handheld support assembly with respect to the axis of the fixed base 1 is realized, and the adjustment range is from +30° to -30°. The meshing structure of the toothed groove and the convex teeth realizes mechanical locking after angle adjustment, adapting to the scanning needs in different anatomical orientations.

[0024] The operation procedure of the present invention is as follows.

[0025] First, open the first semi-annular body 2 and the second semi-annular body 3 of the fixed base 1, mount them on the outer periphery of the cylindrical handle portion 12 of the probe body of the transvaginal ultrasound probe, and insert the annular protrusion on the elastic friction pad into the annular positioning groove 13 of the probe. Subsequently, rotate the tightening handle 4 to tightly close the first semi-annular body 2 and the second semi-annular body 3 by the tensile force of the threaded rod, realizing the fixation of the pressure assisting device on the probe body.

[0026] Next, based on the anatomical depth of the subject's pelvic cavity, the tightening knob of the depth adjustment mechanism is loosened, the limit ring 8 is moved along the guide slide rod 9 to the predetermined scale position, and then the tightening knob is tightened. The angle adjustment dial is adjusted to set the inclination angles of the left wing plate 5 and the right wing plate 6, and adapted to the operator's gripping habits.

[0027] Subsequently, the operator grasps the handle 7, places their fingers in the four finger-hold recesses, and inserts the probe detection end into the vagina. When the flexible pad on the surface of the limit ring 8 contacts external tissue, the propulsion stops. At this time, the operator applies radial pressure through the handle 7 and observes the displacement of the window-shaped scale plate in the observation window 10. When the window-shaped scale plate enters the green area, the pressure intensity is maintained and an elastic image of the cervix is ​​collected by the ultrasound system.

[0028] This invention can be applied to the ultrasound prediction and evaluation of spontaneous premature birth in women with singleton pregnancies. For example, the operator can use this invention in routine obstetric ultrasound examinations of pregnant women between 20 and 24 weeks and between 28 and 32 weeks of gestation, specifically as follows:

[0029] Before the examination, the pregnant woman is instructed to urinate and assume the lithotomy position. After standard disinfection and draping, a transvaginal ultrasound probe with a pressure assist device attached is inserted into the vagina. During the examination, the operator sets and locks the safe insertion depth using the limit ring of the depth adjustment mechanism, grasps the handle, places the fingers in the finger rest recess, and guides the probe to the cervical opening under ultrasound image guidance. Subsequently, the operator maintains a stable pressure within the standard pressure range corresponding to the green area, based on feedback from the color area of ​​the observation window, and completes the collection of the following parameters under this standard pressure maintenance state.

[0030] (1) Cervical length: Measure the distance from the inner opening to the outer opening of the cervix along the endometrial line of the cervix.

[0031] (2) Anterior horn of the cervix: With the internal opening of the cervix as the apex, measure the angle between the line connecting the external and internal openings of the cervix and the line connecting the lower anterior wall of the uterus to the internal opening.

[0032] (3) Cervical elasticity parameters: Using the cervical elastography function of the ultrasound diagnostic device, the elasticity ratio, the strain ratio inside the cervical canal, the strain ratio outside the cervical canal, and the stiffness ratio are automatically acquired and recorded.

[0033] (4) Observation of the morphology of the cervical opening: Observe the presence or absence of amniotic fluid and the funneling sign, and record the morphology of the cervical opening. [Explanation of Symbols]

[0034] 1 Fixed base 2. First semi-ring 3. Second semi-ring 4. Tightening handle 5. Left wing plate 6. Right-side wing plate 7. Handle section 8 Limit Rings 9 Guide slide rod 10 Observation window 11 Detection end 12 Columnar stalk 13 Annular positioning groove

Claims

1. A transvaginal ultrasound probe equipped with a pressure assist device, comprising a probe body having a detection end and a columnar handle portion, and further comprising a pressure assist device attached to the outer circumference of the columnar handle portion, the pressure assist device comprising a fixed base, a handheld support assembly, a depth adjustment mechanism and a pressure state display mechanism, The fixed base grips the outer circumference of the columnar handle portion, The handheld support assembly includes a left wing plate and a right wing plate provided symmetrically on both sides of the fixed base, and each of the left wing plate and the right wing plate includes a support rod and a handle portion connected to the outside of the support rod, and the back surface of the handle portion is provided with a plurality of finger rest recesses. The depth adjustment mechanism includes a guide slide rod and a limit ring, the guide slide rod being fixed to the fixed base and extending toward the detection end, and the limit ring being slidably fitted onto the guide slide rod. A transvaginal ultrasound probe equipped with a pressurizing assist device, characterized in that the pressure state display mechanism includes an elastic compensating spring, a displacement transmission rod, and an observation window, a cavity is formed inside the support rod, the elastic compensating spring is housed in the cavity, one end of the displacement transmission rod abuts against the elastic compensating spring, a window-shaped scale plate is connected to the other end, and the observation window is provided on the side of the handle portion.

2. The transvaginal ultrasound probe equipped with a pressurizing aid according to claim 1, characterized in that the fixed base is formed by butting together a first semi-annular body and a second semi-annular body, the first semi-annular body and the second semi-annular body are closed by a tightening handle to form a cylindrical containment cavity that grips the columnar handle, an elastic friction pad is provided on the inner wall of the cylindrical containment cavity, an annular positioning groove is provided on the outer circumferential surface of the columnar handle, and an annular projection that fits into the annular positioning groove is provided on the elastic friction pad.

3. A transvaginal ultrasound probe equipped with a pressure assist device according to claim 1, characterized in that the radius of curvature of the finger-holding recess is 10 mm to 15 mm, the distance between the centers of two adjacent finger-holding recesses is 20 mm, and the depth of the finger-holding recess gradually decreases from top to bottom, with the uppermost finger-holding recess having a depth of 8 mm and the lowermost finger-holding recess having a depth of 4 mm.

4. A transvaginal ultrasound probe equipped with a pressurizing assist device according to claim 1, characterized in that the edge of the observation window is provided with a plurality of color regions representing different pressure levels.

Images