Multi-section self-adaptive bent vaginal speculum

Abstract

The invention provides a multi-section type self-adaptive curved vaginal speculum which comprises a columnar body, and the outer diameter of the columnar body is closed within the diameter range suitable for vagina insertion. The device has the advantages that the structural design is high in adjustability, and the device can adapt to the body structures of different patients; an intelligent navigation system is built in, so that the operation precision and efficiency are improved; the material selection is scientific, and the material has high strength, high durability and biocompatibility; various clinical special functional modules are provided, and diversified requirements before, during and after an operation are met.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of specula, in particular to a multi-section self-adaptive curved vaginal speculum. BACKGROUND

[0002] With the rapid development of medical technology, the demand for precise operation of female genital parts in gynecological examination and surgery is increasing. The vaginal speculum, as an important auxiliary tool, plays an important role in preoperative examination, intraoperative navigation and postoperative observation. However, the existing vaginal speculum has the following problems: The traditional structure design is fixed, which is difficult to adapt to the diagnosis needs of different patients, resulting in patient discomfort; Lack of intelligent navigation function, resulting in limited examination field and surgical precision; Limited material selection, some materials are easily affected by the environment, affecting the service life. SUMMARY

[0003] Therefore, the present application aims to provide a multi-section self-adaptive curved vaginal speculum to solve the above-mentioned problems of existing technology, such as patient discomfort, low operation efficiency and single function.

[0004] To achieve the above-mentioned purpose, the technical solution of the present application is as follows: A multi-section self-adaptive curved vaginal speculum, comprising a columnar body, the closed outer diameter of the columnar body is suitable for the diameter range of vaginal insertion; The columnar body comprises at least five sections of ball-and-socket joints in series, the maximum deflection angle of a single ball-and-socket joint is 25°, and the plurality of ball-and-socket joints form a leaf structure of the columnar body with a total bending angle of 0°-120°; Further comprising a shape memory alloy driving wire and a central processing unit, the shape memory alloy driving wire is installed on the ball-and-socket joint, and the central processing unit is used to control the shape memory alloy driving wire; Further comprising a plurality of independently arranged instrument channel operation control units, the independent instrument channel is arranged in the columnar body, and the independent instrument channel is used to place a cold light source optical fiber, a camera and a laser optical fiber.

[0005] Further, when the leaf of the columnar body is two leaves, further comprising a control handle and a limiting mechanism, the control handle is installed at one end of the columnar body, the limiting mechanism is arranged on the control handle, and the limiting mechanism is used to position the opening and closing state of the columnar body.

[0006] Further, the limiting mechanism comprises a limiting rod and a limiting nut, the control handle comprises a fixed handle and a rotating handle, the fixed handle is connected with the blade at the lower end of the columnar body, the rotating handle is connected with the blade at the upper end of the columnar body, the limiting rod is installed to the fixed handle after passing through the rotating handle, and an external thread section is arranged at the end of the limiting rod close to the rotating handle, and the limiting nut is threadedly connected to the limiting rod.

[0007] Further, when the number of blades of the columnar body is not less than three, the control handle and the opening and closing mechanism are further included, the opening and closing mechanism is installed to one end of the columnar body, the opening and closing mechanism is used for controlling the opening and closing of the outer diameter of the columnar body, and the control handle is further installed below one end of the columnar body.

[0008] Further, the opening and closing mechanism comprises a stepping motor, a transmission wheel and a driven part, the output shaft of the stepping motor is coaxially connected with the transmission wheel, the transmission wheel is in transmission connection with the driven part, the driven part is installed to one end of the columnar body, a plurality of swingable driven teeth are arranged on the outer circle of the driven part, and the driven teeth can drive the blades on the columnar body to swing or expand.

[0009] Further, the contact surface of the ball-and-socket joint is provided with a self-lubricating coating, the coating is a composite material of polytetrafluoroethylene and molybdenum disulfide, and the thickness is 50-80 μm.

[0010] Further, the surface of the blade is covered with a nano-composite lubricating layer, the nano-composite lubricating layer is composed of polytetrafluoroethylene and graphene at a mass ratio of 7:3, and the thickness is 50-80 nm.

[0011] Further, the shape memory alloy driving wire is arranged in a double helix structure, the helix rise angle is 30-60°, and the pre-strain rate is 2-4%.

[0012] Further, the base body of the columnar body is medical grade 316LVM stainless steel, and the surface coating is a silica gel layer formed by plasma spraying process, and the thickness is 0.5-1.2 mm.

[0013] Further, the central processing unit comprises a pressure sensor distributed on the diaphragm of each ball-and-socket joint, and the pressure sensor triggers the tactile feedback and / or the audible and light alarm when the pressure exceeds the set threshold.

[0014] Further, the operation control unit comprises a temperature sensor, a motor driving module and an alarm module, the temperature sensor is used for temperature compensation, the motor driving module is used for driving the blades of the columnar body, and the alarm module is used for audible and light alarm.

[0015] Further, the instrument channel comprises a central main channel, the central main channel is used for placing a cold light source optical fiber, auxiliary channels are arranged on both sides of the central main channel, and the two auxiliary channels are respectively used for placing a camera and a laser optical fiber.

[0016] Further, the operation control unit integrates a BLE module, which can transmit pressure and temperature data to an external terminal in real time, and a CMOS camera.

[0017] Further, the ball-and-socket joint comprises a blade body, a ball head, a socket seat and an O-ring, the ball head is installed at one end of the blade body, the socket seat is installed at the other end of the blade body, the ball head and the socket seat are used in cooperation between adjacent blade bodies, and the O-ring is installed between the ball head and the socket seat, and a wire passage aperture is formed in the blade body.

[0018] Further, when the number of blades of the columnar body is not less than three, a self-adaptive sealing film is arranged between adjacent blade bodies, the sealing film is made of a silicone-polyurethane composite material, and the tensile strength is greater than or equal to 8 MPa, so that the sealing film can automatically adhere to the vaginal wall to form a closed channel when the blade body is unfolded.

[0019] Further, the head of the columnar body integrates a graphene infrared bacteriostatic treatment module, which comprises a graphene infrared coating with a wavelength of 8.5-9.6 microns, and a UVC LED lamp bead with a wavelength of 265-280 nm and a power density of 50-100 mW / cm 2 , to induce the graphene infrared to emit infrared rays with a wavelength of 8.5-9.6 microns.

[0020] Further, the ball-and-socket joint adopts an asymmetric reinforcement design, wherein the wall thickness of the odd-numbered sections is increased by 0.2-0.5 mm, and the number of shape memory alloy driving wires corresponding to the sections is doubled.

[0021] Further, the temperature sensor is dynamically adjusted, and the input parameters include the ambient temperature, the use time and the joint bending angle, and the control period is less than or equal to 100 ms.

[0022] Further, the BLE module supports the docking of a surgical navigation system, can receive MRI / CT image data and realize augmented reality superimposed display on the display screen of the operation control unit, and the registration error is less than or equal to 1.5 mm.

[0023] Further, the operation control unit integrates a safety self-locking module, which is automatically triggered when the expansion width exceeds 40 mm or the bending angle is greater than 120°.

[0024] Compared with the prior art, the multi-section self-adaptive curved vaginal speculum has the following advantages: The multi-section self-adaptive curved vaginal speculum has the following advantages: strong adjustability of the structure design, can adapt to the body structure of different patients; built-in intelligent navigation system, improves the operation precision and efficiency; scientific material selection, high strength, high durability and biocompatibility; multiple clinical special function modules, meet the diversified needs before, during and after the operation. BRIEF DESCRIPTION OF DRAWINGS

[0025] The accompanying drawings, which form a part of the specification, are included to provide a further understanding of the application and are incorporated herein by reference. The illustrations in the drawings for the most part are of the embodiments of the application and the description and discussion thereof serve to explain the principles of the application. In the drawings: Figure 1 Structure diagram of two-leaf speculum for vagina for the embodiment of the present application; Figure 2 Structure diagram of multi-leaf speculum for vagina for the embodiment of the present application; Figure 3 Side view diagram of columnar body for the embodiment of the present application; Figure 4 Partial sectional view diagram of columnar body for the embodiment of the present application; Figure 5 Exploded diagram of ball-and-socket joint for the embodiment of the present application; Figure 6 Partial enlarged diagram of ball-and-socket joint for the embodiment of the present application; Figure 7 Diagram of ball head, socket seat and O-ring for the embodiment of the present application; Figure 8 Diagram of follower closure for the embodiment of the present application; Figure 9 Diagram of follower expansion for the embodiment of the present application; Figure 10 Diagram of clinical use state one for the embodiment of the present application; Figure 11 Diagram of clinical use state two for the embodiment of the present application; Figure 12 Diagram of clinical use state three for the embodiment of the present application; Figure 13 Diagram of operation control unit for the embodiment of the present application.

[0026] BRIEF DESCRIPTION OF DRAWINGS 100, columnar body; 101, control handle; 102, opening and closing mechanism; 1021, transmission wheel; 1022, driven member; 103, limiting mechanism; 1031, limiting rod; 1032, limiting nut; 104, instrument channel; 1041, central main channel; 1042, auxiliary channel; 105, nano-composite lubricating layer; 106, base body; 107, silica gel layer; 200, ball and socket joint; 201, blade body; 202, ball head; 203, socket seat; 2031, composite material layer; 2032, cylindrical brazing point; 204, O-ring; 205, wire channel aperture; 206, shape memory alloy driving wire; 300, operation control unit; 301, central processing unit; 302, pressure sensor; 303, temperature sensor; 304, motor driving module; 305, alarm module; 306, BLE module; 400, human body to be examined or surgical site; 401, labia majora; 402, labia minora; 403, anus; 404, vagina; 405, cervix; 406, uterus. DETAILED DESCRIPTION

[0027] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict.

[0028] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second" and the like are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features limited by "first", "second" and the like can explicitly or implicitly include one or more features. In the description of the present application, unless otherwise specified, the meaning of "a plurality of" is two or more.

[0029] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood through specific circumstances.

[0030] The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0031] like Figures 1 to 13 As shown, a multi-section adaptive curved vaginal speculum comprises a cylindrical body 100, wherein the closed outer diameter of the cylindrical body 100 is suitable for a diameter range of vaginal insertion; The columnar body 100 includes at least five ball-and-socket joints 200 connected in series. The maximum deflection angle of a single ball-and-socket joint 200 is 25°. The multiple ball-and-socket joints 200 form a blade structure of the columnar body 100, and the total bending angle is 0°-120°. It also includes a shape memory alloy drive wire 206 and a central processing unit 301. The shape memory alloy drive wire 206 is installed on the ball head 202 of the ball and socket joint 200. The central processing unit 301 is used to control the shape memory alloy drive wire 206. Specifically, in actual use, the central processing unit 301 receives the pressure (0-1N / cm² range) monitored in real time by the thin film pressure sensor 302, and calculates the current intensity of the shape memory alloy drive wire 206 based on its pressure data; and heats the shape memory alloy drive wire 206 through the current to contract, thereby driving the ball and socket joint to bend.

[0032] It also includes an operation control unit 300 for a plurality of independently arranged instrument channels 104 , wherein the independent instrument channels 104 are arranged in the columnar body 100 , and the independent instrument channels 104 are used to place cold light source optical fibers, cameras and laser optical fibers.

[0033] In a preferred embodiment of the present invention, when the columnar body 100 has two leaves, it also includes a control handle 101 and a limiting mechanism 103. The control handle 101 is installed to one end of the columnar body 100, and the limiting mechanism 103 is set on the control handle 101. The limiting mechanism 103 is used to position the opening and closing state of the columnar body 100.

[0034] In a preferred embodiment of the present invention, the limiting mechanism 103 includes a limiting rod 1031 and a limiting nut 1032. In actual use, the control handle 101 includes a fixed handle and a rotating handle. The fixed handle is connected to the blades at the lower end of the columnar body 100, and the rotating handle is connected to the blades at the upper end of the columnar body 100. The limiting rod 1031 passes through the rotating handle and is installed to the fixed handle. The limiting rod 1031 is provided with an external thread section near one end of the rotating handle, and the limiting nut 1032 is threadedly connected to the limiting rod 1031. In this way, when the operator presses one end of the rotating handle, the blades at the upper and lower ends of the columnar body 100 can be unfolded, and then the limiting nut 1032 is used to limit the rotating handle to keep the two blades of the columnar body 100 in the unfolded state.

[0035] In a preferred embodiment of the present application, when the number of blades of the columnar body 100 is not less than three, the control handle 101 and the opening and closing mechanism 102 are further included, the opening and closing mechanism 102 is installed to one end of the columnar body 100, and the opening and closing mechanism 102 is used to control the opening and closing of the outer diameter of the columnar body 100. The control handle 101 is further installed below one end of the columnar body 100. In this embodiment, the control handle 101 has only one handle.

[0036] In a preferred embodiment of the present application, the opening and closing mechanism 102 includes a stepping motor, a transmission wheel 1021 and a driven part 1022. The output shaft of the stepping motor is coaxially connected with the transmission wheel 1021, the transmission wheel 1021 is in transmission connection with the driven part 1022, the driven part 1022 is installed to one end of the columnar body 100, and the outer circle of the driven part 1022 is provided with a plurality of swingable driven teeth which can drive the blades on the columnar body 100 to swing. In actual use, when it is needed to open the plurality of blades of the columnar body 100, the output shaft of the stepping motor is rotated to drive the transmission wheel 1021 to rotate, the transmission wheel 1021 is rotated to make the driven teeth of the driven part 1022 expand, the driven teeth are expanded to drive the blades to expand, and then the blades are in the expanded state.

[0037] In a preferred embodiment of the present application, the contact surface of the ball joint 200 is provided with a self-lubricating coating, and the coating composition is a composite material of polytetrafluoroethylene and molybdenum disulfide, and the thickness is 50-80 μm.

[0038] In a preferred embodiment of the present application, the surface of the blade is covered with a nano-composite lubricating layer 105 which is composed of polytetrafluoroethylene (PTFE) and graphene at a mass ratio of 7:3, and the thickness is 50-80 nm.

[0039] In a preferred embodiment of the present application, the shape memory alloy driving wire 206 is arranged in a double helix structure, the helix rise angle is 30-60°, and the pre-strain rate is 2-4%.

[0040] In a preferred embodiment of the present application, the base body 106 of the columnar body 100 is medical grade 316LVM stainless steel, and the surface coating layer is a silica gel layer 107 formed by plasma spraying process, and the thickness is 0.5-1.2 mm, which meets the ISO 10993 biocompatibility standard.

[0041] In a preferred embodiment of the present application, the central processing unit 301 includes a pressure sensor 302 distributed on the diaphragm of each ball joint 200, and the measurement range is 0-1 N / cm². When the pressure exceeds the set threshold value, the tactile feedback and / or audible and light alarm are triggered.

[0042] In a preferred embodiment of the present application, the operation control unit 300 integrates a temperature sensor 303, a motor drive module 304 and an alarm module 305, the temperature sensor 303 is used for temperature compensation, controlling the heating temperature of the shape memory alloy driving wire 206, the temperature control accuracy is ±0.5℃, and the working temperature can be automatically adjusted according to the user's body temperature.

[0043] In a preferred embodiment of the present application, a self-lubricating drug delivery channel is also provided in the columnar body 100, and various drug sustained-release micropore structures such as lidocaine are arranged on the inner wall of the channel, the pore size is 20-50μm, and the drug release rate is 0.1-0.5mg / min.

[0044] In a preferred embodiment of the present application, the instrument channel 104 includes a central main channel 1041 with a diameter of 5mm and an adjustable deflection angle of ±15°, the central main channel 1041 is used for placing a cold light source optical fiber, and auxiliary channels 1042 with a diameter of 3mm are arranged on both sides of the central main channel 1041 and are provided with anti-reflux sealing valves, the two auxiliary channels 1042 are respectively used for placing a camera and a laser optical fiber, and the instrument channel 104 adopts a standard luer connector design and is compatible with hysteroscopes, laser optical fibers and other medical equipment.

[0045] In a preferred embodiment of the present application, the operation control unit 300 integrates a BLE module 306 supporting Bluetooth 5.0 or Wi-Fi 6 protocol, which can transmit pressure and temperature data to an external terminal in real time, and is provided with a 20-60 million pixel CMOS camera with a resolution of ≥1920×1080.

[0046] In a preferred embodiment of the present application, the columnar body 100 is made of degradable polylactic acid-glycolic acid copolymer (PLGA) material, and the degradation period is controllable for 6-24 months, and the degradation product pH value is maintained at 6.8-7.4.

[0047] In a preferred embodiment of the present application, the ball-and-socket joint 200 includes a blade body 201, a ball head 202, a socket seat 203 and an O-ring 204, one end of the blade body 201 is provided with the ball head 202, the other end of the blade body 201 is provided with the socket seat 203, the ball head 202 and the socket seat 203 are used in cooperation between adjacent blade bodies 201, and the O-ring 204 is installed between the ball head 202 and the socket seat 203, and a wire passage aperture 205 is also formed in the blade body 201. In actual use, a composite material layer 2031 (PTFE-MoS2) is also coated on the inner surface of the socket seat 203, and one end of the socket seat 203 is installed to the blade body 201 through a cylindrical copper welding point 2032.

[0048] In a preferred embodiment of the present application, the head of the columnar body 100 is integrated with an graphene infrared bacteriostatic module, which contains a graphene infrared coating with a wavelength of 8.5-9.6 microns. The graphene infrared emission is induced by a UVC LED lamp bead with a wavelength of 265-280 nm and a power density of 50-100 mW / cm², which emits infrared rays with a wavelength of 8.5-9.6 microns (forming a same frequency resonance with the 9.36 micron infrared rays emitted by the human body). In the closed state of the columnar body and the desired treatment opening angle, the angle of the columnar body can be freely controlled, and the automatic treatment cycle can be set by operating the control unit 300.

[0049] In a preferred embodiment of the present application, the ball-and-socket joint 200 adopts an asymmetric reinforcement design, in which the wall thickness of the odd-numbered sections is increased by 0.2-0.5 mm, and the number of shape memory alloy driving wires 206 in the corresponding sections is doubled, which is used to adapt to the anatomical structure of patients with a posterior-inclined uterus.

[0050] In a preferred embodiment of the present application, the manufacturing process of the ball-and-socket joint 200 includes: a) Precise injection molding is adopted, and the mold tolerance is controlled within ±0.01 mm; b) The injection pressure is 80-120 MPa, and the holding time is 3-5 seconds; c) The post-processing process includes plasma polishing (in an argon environment with a power of 300 W).

[0051] In a preferred embodiment of the present application, the temperature sensor 303 is dynamically adjusted, and the input parameters include the ambient temperature, the use time, and the joint bending angle, and the control period is ≤100 ms.

[0052] In a preferred embodiment of the present application, the BLE module 306 supports the docking of a surgical navigation system, can receive MRI / CT image data, and realize augmented reality (AR) superimposed display on the display screen of the operation control unit 300, with a registration error ≤1.5 mm.

[0053] In a preferred embodiment of the present application, the tail of the columnar body 00 is provided with a modular expansion interface, which can be detachably connected to one of the following functional modules: A microwave hemostasis probe with a working frequency of 2.45 GHz and a power adjustable from 0 to 50 W; A bioelectricity detection electrode with an impedance measurement range of 10 Ω-1 MΩ; A drug sustained-release capsule with a drug loading capacity of 50-200 mg.

[0054] In a preferred embodiment of the present application, hydroxyapatite nanoparticles (content 5-15 wt%) are added to the degradable PLGA material, and the calcium to phosphorus molar ratio (Ca / P) of the degradation product is controlled within 1.6-1.8.

[0055] In a preferred embodiment of the present application, the slow-release micropores of the self-lubricating administration channel are formed by laser processing, and the inner wall of the channel has a spiral flow guide groove with a flow guide angle of 20-35° and a flow rate control accuracy of ±5%.

[0056] In a preferred embodiment of the present application, the operation control unit 300 is integrated with a postoperative care function module, which includes: a vaginal pH value monitoring sensor with a range of 3.0-8.0; a tissue healing evaluation algorithm based on impedance change rate to determine the healing stage; a customized care plan output interface.

[0057] In a preferred embodiment of the present application, the operation control unit 300 is integrated with a safety self-locking module that automatically triggers mechanical locking when the expansion width exceeds 40mm or the bending angle is >120°.

[0058] In a preferred embodiment of the present application, an adaptive sealing film is provided between the blade bodies 201 of the multi-leaf structure, which is made of a silicone-polyurethane composite material with a tensile strength ≥8MPa and can automatically adhere to the vaginal wall to form a sealed channel when the blades are expanded.

[0059] In a preferred embodiment of the present application, an illumination observation system can also be installed, which includes a detachable imaging module that supports connection with electronic colposcopy or 3D endoscopy imaging equipment.

[0060] Advantages of the present application: The structural design has strong adjustability and can adapt to the body structures of different patients; the built-in intelligent navigation system improves surgical precision and efficiency; the material selection is scientific, with high strength, high durability and biocompatibility; and various clinical special function modules are provided to meet the diverse needs before, during and after surgery.

[0061] Example 1: Basic speculum Manufacturing process: (1) Base body forming: 316LVM stainless steel skeleton (tolerance ±0.05mm) manufactured by metal injection molding (MIM) process (2) Surface treatment: plasma spraying of medical silicone (thickness 0.8mm, Shore hardness 35A) (3) Joint assembly: press-fit ball joint (axial pre-tightening force 5N), wrapped with nickel-titanium alloy wire Blade design: multi-blade design, such as a three-blade structure, with three expansion blades symmetrically distributed at 120°, and the thickness of each blade gradually increases from 0.6mm at the root to 1.8mm at the tip.

[0062] Basic surgery speculum Columnar body: made of high-density polyethylene (HDPE) and graphene composite material, combined with plasma polishing process to improve biocompatibility and durability; Ball joint: high precision and corrosion resistance achieved through precision injection molding and ultrasonic cleaning process; Blade function: multi-leaf blades, such as four-leaf or six-leaf structure, with self-adaptive sealing membrane between the blades, not shown in the specification drawings, made of silicone-polyurethane composite material with a tensile strength of ≥8MPa. Due to the high tensile strength and material selection, the self-adaptive sealing membrane will not tear, entangle or interfere, and can automatically adhere to the vaginal wall to form a sealed passage when the blades are expanded, without interfering with the expansion and closure of the blades.

[0063] As shown in Figures 10 to 12 the speculum is applied to the human body part to be examined or operated 400, which includes the labia majora 401, the labia minora 402, the anus 403, the vagina 404, the cervix 405 and the uterus 406.

[0064] Basic operation process: Step 1: insert into the vagina 404 at a 30° angle in the closed state; Step 2: rotate the locking ring to the second gear; Step 3: slowly advance the telescopic push rod until the cervix 405 is reached; Insert to the outer cervix (depth marker line alignment); Expand to the target width (pressure indicator light turns green); Perform examination / surgery through the central channel; Basic surgery operation process: Step 1: insert into the vagina 404 at a 30° angle in the closed state; Step 2: rotate the locking ring to the second gear; Step 3: slowly advance the telescopic push rod until the cervix 405 is reached; Insert to the outer cervix (depth marker line alignment); Expand to the target width (pressure indicator light turns green, sealing membrane expands to automatically adhere to the vaginal wall to form a sealed passage for clinical surgical operation, preventing vaginal tissue from affecting the surgical field of view); Perform examination / surgery through the central channel; Example 2: Intelligent speculum Enhanced functions: AI recognition: 2 million pixel camera + ResNet50 model, cervical lesion recognition accuracy 96.7%; AR navigation: aligns preoperative CT data (error ≤ 1.2mm) and displays the spatial relationship between instruments and anatomical structures in real time; Postoperative care: pH sensor monitors vaginal environment and outputs customized rehabilitation plans; Example 3: Disposable biodegradable speculum Manufacturing process: Matrix molding: PLGA-based biodegradable material (added with 15wt% hydroxyapatite), degradation cycle adjustable from 6 to 24 months (tolerance ±0.05mm); Surface treatment: plasma sprayed medical silicone (thickness 0.8mm, Shore hardness 35A); (3) Joint assembly: press-fit ball and socket joint (axial preload 5N); Example 4: Disposable speculum Manufacturing process: (1) One-time injection molding: mainly made of transparent polystyrene (PS), ABS, AS, and polypropylene resin materials; (2) Surface treatment: The surface is covered with a nano-composite lubricating layer, which is composed of polytetrafluoroethylene (PTFE) and graphene in a mass ratio of 7:3 and has a thickness of 50-80nm.

[0065] (3) Joint assembly: Press-fit ball and socket joint (axial preload 5N).

[0066] Clinical tests have shown that compared to traditional devices: Cervical exposure time was shortened by 58% (29 seconds vs 69 seconds, P < 0.01); Patients' pain scores decreased by 64% (VAS 2.1 vs 5.8); The incidence of postoperative complications decreased by 82% (3.2% vs 17.5%); This device is particularly suitable for minimally invasive surgical operations in complex cases such as retroverted uterus and obese patients.

[0067] 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 principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A multi-section self-adapting curved vaginal speculum, characterized in that: The application relates to a medical device, which comprises a columnar body (100) with a closed outer diameter suitable for vaginal (404) insertion; the columnar body (100) comprises at least five segments of a ball-and-socket joint (200) with a maximum deflection angle of 25 degrees, and the plurality of ball-and-socket joints (200) form a blade structure of the columnar body (100) with a total bending angle of 0-120 degrees; the device further comprises a shape memory alloy driving wire (206) and a central processing unit (301) for controlling the shape memory alloy driving wire (206); the device further comprises an operation control unit (300) of a plurality of independently arranged instrument channels (104) arranged in the columnar body (100), and the instrument channels (104) are used for placing cold light source optical fibers, cameras and laser fibers; the central processing unit (301) comprises a pressure sensor (302) arranged on a diaphragm of each ball-and-socket joint (200) and having a measuring range of 0-1 N / cm2, and the pressure sensor (302) triggers a tactile feedback and / or an audible and light alarm when the pressure exceeds a set threshold value. When the blade of the columnar body (100) is two-blade, the device further comprises a control handle (101) and a limiting mechanism (103), the control handle (101) is mounted to one end of the columnar body (100), the limiting mechanism (103) is arranged on the control handle (101), and the limiting mechanism (103) is used for positioning the opening and closing state of the blade of the columnar body (100). The limiting mechanism (103) comprises a limiting rod (1031) and a limiting nut (1032), the control handle (101) comprises a fixed handle and a rotating handle, the fixed handle is connected with the blade at the lower end of the columnar body (100), the rotating handle is connected with the blade at the upper end of the columnar body (100), the limiting rod (1031) passes through the rotating handle and is mounted to the fixed handle, one end of the limiting rod (1031) close to the rotating handle is provided with an external thread section, and the limiting nut (1032) is threadedly connected to the limiting rod (1031). When the blade of the columnar body (100) is not less than three-blade, the device further comprises a control handle (101) and an opening and closing mechanism (102), the opening and closing mechanism (102) is mounted to one end of the columnar body (100), the opening and closing mechanism (102) is used for controlling the opening and closing of the outer diameter of the columnar body (100), and the control handle (101) is further mounted below one end of the columnar body (100). The opening and closing mechanism (102) comprises a stepping motor, a transmission wheel (1021) and a driven part (1022), the output shaft of the stepping motor is coaxially connected with the transmission wheel (1021), the transmission wheel (1021) is in transmission connection with the driven part (1022), the driven part (1022) is mounted to one end of the columnar body (100), a plurality of swingable driven teeth are arranged on the outer ring of the driven part (1022), and the driven teeth can drive the blade on the columnar body (100) to swing.

2. A multi-section self-adapting curved vaginal speculum according to claim 1, wherein: The contact surface of the ball-and-socket joint (200) is provided with a self-lubricating coating, the coating is a composite material of polytetrafluoroethylene and molybdenum disulfide, and the thickness is 50-80 mu m.

3. A multi-section self-adapting curved vaginal speculum according to claim 2, wherein: ​ 4. A multi-section self-adapting curved vaginal speculum according to claim 1, wherein: ​ 5. A multi-section self-adapting curved vaginal speculum according to claim 4, wherein: ​ 6. A multi-section self-adapting curved vaginal speculum according to claim 1, wherein: ​ 7. A multi-section self-adapting curved vaginal speculum according to claim 1, wherein: The operation control unit (300) comprises a temperature sensor (303) for temperature compensation, a motor driving module (304) for driving the blades of the columnar body (100), and an alarm module (305) for sound and light alarm.

8. A multi-section self-adapting curved vaginal speculum according to claim 1, wherein: The instrument channel (104) comprises a central main channel (1041) for placing a cold light source optical fiber, and two auxiliary channels (1042) arranged on both sides of the central main channel (1041), wherein the two auxiliary channels (1042) are respectively used for placing a camera and a laser optical fiber.

9. A multi-section self-adapting curved vaginal speculum according to claim 1, wherein: The ball-and-socket joint (200) comprises a blade body (201), a ball head (202), a socket (203) and an O-ring (204), one end of the blade body (201) is provided with the ball head (202), the other end of the blade body (201) is provided with the socket (203), the ball head (202) and the socket (203) are used in cooperation between adjacent blade bodies (201), the O-ring (204) is arranged between the ball head (202) and the socket (203), and a wire passage aperture (205) is further formed in the blade body (201).

10. A multi-section self-adapting curved vaginal speculum according to claim 9, wherein: When the number of blades of the columnar body (100) is not less than three, a self-adaptive sealing film is arranged between adjacent blade bodies (201), the sealing film is made of a silicone-polyurethane composite material, the tensile strength is greater than or equal to 8 MPa, and the sealing film can automatically adhere to the wall of the vagina (404) to form a closed channel when the blade body (201) is unfolded.

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