Vaginal speculum capable of achieving shadowless illumination for obstetrics and gynecology department

Abstract

The invention discloses a shadowless illumination vaginal speculum for gynaecology and obstetrics. The vaginal speculum body is made of high-transparency materials such as polypropylene or polystyrene, and light penetration is guaranteed. The lighting system comprises an annular LED lamp ring, uniform shadowless lighting is provided for an operation opening, light utilization is optimized through mirror image design of the non-light-transmitting inner face of the rear cover, and the eyes of a doctor are prevented from being directly irradiated. The adjusting mechanism is provided with an adjusting rod, a screw rod and an adjusting nut, and stepless accurate adjustment of an opening of the vaginal speculum is achieved. The upper and lower clamp arms are designed according to the physiological structure of the human body, the 110-degree included angle of the lower clamp arm avoids sickbed interference, and operation is convenient. The sealing assembly covers a sealing ring, a standby sealing gasket and a thin sealing gasket, so that the sealing performance of each part is ensured, and body fluid and dust are prevented from invading; the fixing layer reinforces the key area; and the splicing pieces are stably connected with all the components. Before use, medical care can select batteries and illuminate according to needs, after use, parts can be cleaned, disinfected and maintained, and the gynaecology and obstetrics examination and operation efficiency, safety and hygiene are effectively improved.

Description

Technical Field

[0001] The present invention relates to the field of obstetrics and gynecology medical devices, and in particular to a vaginal dilator with the functions of shadowless lighting, smoke extraction, optimized structural design and convenient battery use. Background Art

[0002] In the field of obstetrics and gynecology, the vaginal dilator is an important and commonly used instrument. Traditional vaginal dilators usually only have the basic function of opening the vagina, and many problems are exposed during actual use.

[0003] In terms of lighting, traditional vaginal dilators do not have their own light source. Doctors must rely on external lighting equipment, such as surgical lights, when performing examinations or surgical operations. This not only increases the complexity of the operation and requires additional manpower or equipment to adjust the lighting angle and position, but also the external lighting is often difficult to fully meet the lighting needs inside the vagina, and it is easy to have light blind spots. Although there are some similar products with lighting on the market, they generally have serious defects. For example, [citing relevant prior art documents, such as patent documents or product instructions of a certain brand of vaginal dilators with lighting], the unreasonable design of its light source leads to light dispersion, making the lighting inside the vagina uneven, and producing shadow patches, which greatly affects the doctor's observation of the subtle structure and lesion inside the vagina, and increases the risk of misdiagnosis or missed diagnosis. At the same time, the light sources of these products are not designed to protect the doctor's eyes, and there is a certain direct illumination phenomenon. Long-term operation will cause eye fatigue of the doctor and may even affect the doctor's vision, thereby reducing the accuracy and safety of the operation or examination.

[0004] In terms of surgical smoke treatment, smoke is often produced during gynecological and obstetric surgeries such as leep knife surgery. These smokes contain tiny particles and water vapor produced by tissue gasification, which will quickly diffuse in the surgical field of view. Traditional dilators do not have a special smoke treatment mechanism. After the smoke accumulates, it seriously obstructs the doctor's vision and interferes with the doctor's judgment of the surgical site, making the operation more difficult, prolonging the operation time, and increasing the surgical risk to the patient accordingly. From the perspective of structural design, the lower clamp of the traditional dilator is mostly designed at a right angle. In daily examinations, due to differences in the patient's examination posture, the position and height of the bed are also different, and the lower clamp with a right angle design often interferes with the bed. This interference limits the operating angle and field of view of the operating doctor. The doctor may need to spend extra energy to adjust the patient's posture or his own operating position, which reduces the efficiency of medical operations and brings great inconvenience to the doctor. In addition, in terms of expansion angle adjustment, the adjustment method of the traditional dilator is relatively rough, and it is difficult to achieve precise angle control. This cannot meet the doctor's needs for fine operation according to the specific situation of the patient in some examinations or surgeries that require a high degree of dilator expansion, which may affect the accuracy of the examination results and the effect of surgical treatment.

[0005] In summary, the existing gynecological and obstetric dilators have problems in lighting, smoke treatment, structural design and angle adjustment. There is an urgent need for a new type of dilator to solve these technical problems in order to improve the efficiency, accuracy and safety of gynecological and obstetric medical operations. Summary of the invention

[0006] The purpose of this section is to summarize some aspects of embodiments of the present invention and briefly introduce some preferred embodiments. Some simplifications or omissions may be made in this section and the specification abstract and the invention title of this application to avoid blurring the purpose of this section, the specification abstract and the invention title, and such simplifications or omissions cannot be used to limit the scope of the present invention.

[0007] In view of the above problems and / or the problems existing in the prior art, the present invention is proposed.

[0008] Therefore, the present invention aims to provide a vaginal dilator with shadowless lighting for obstetrics and gynecology and a method of using the same, so as to effectively solve the problems existing in the prior art and improve the convenience and accuracy of clinical operations in obstetrics and gynecology. 1. Sealing ring, a component used for sealing or fixing, located at an opening of the dilator body, which may be related to the lighting system or the smoke extraction device, and plays a role in sealing or fixing related components to ensure the sealing and functionality of the instrument. 2. Spare sealing pad, a component used for sealing or fixing, located at an opening of the dilator body, which may be related to the lighting system or the smoke extraction device, and plays a role in sealing or fixing related components to ensure the sealing and functionality of the instrument. 3. Fixing layer, a type of sealing or fixing component, which is different from the above two in material, function or use position, and together ensures the overall performance of the instrument. 4. Splicing parts, which are parts used to connect or fix other components, nuts or other fasteners, play a key role in the assembly or adjustment process of the instrument.

[0009] 5. Adjustment rod, a screw used to adjust the expansion angle of the dilator. By cooperating with other components, the size of the dilator opening can be infinitely adjusted to meet different medical operation requirements. 6. The upper clamp arm is one of the main components of the dilator and is used to open the upper part of the vagina. Its shape and size are designed to adapt to the physiological structure of the human body, minimize the patient's discomfort during operation, and provide sufficient opening space for doctors to perform examinations or operations. 7. The lower clamp arm works with the upper clamp arm to open the vagina together. The lower clamp arm is designed with an angle of 110° (clearly marked in the figure). Compared with the traditional right-angle lower clamp, this design can effectively avoid interference with the surrounding environment such as the bed, providing doctors with a wider operating space and a better field of vision. 8. The screw, corresponding to the black slender rod, is a key component for adjusting the expansion angle of the dilator. By rotating the screw, the relevant structure can be driven to move, thereby achieving precise adjustment of the size of the dilator opening to meet the needs of different patients and different medical operations. 9 Adjusting nut, used in conjunction with the screw, to fix the position of the screw to ensure that the dilator can remain stable after being adjusted to the appropriate angle and will not loosen or shift during operation. 10 Solid and tight connection reinforcement, is a reinforcing structure or sealing structure at the connection between the upper clamp arm and the main body, used to enhance the strength and sealing of this part to ensure the reliability and durability of the instrument. 11 Fine sealing gasket, made of materials with good elasticity and sealing properties, such as rubber, silicone, etc. Sealing gaskets can fill tiny gaps between components and fit tightly when under pressure to form an effective sealing barrier. For example, at some joints, pipe interfaces and other parts of the dilator, sealing gaskets can prevent liquid leakage and gas escape, ensuring the normal operation and hygienic safety of the instrument.

[0010] Preferably, a sealing ring (1) is provided at the key opening of the dilator body. It is carefully made of high-quality elastic material and fits the opening contour tightly, effectively ensuring the sealing and stability of the connection between this part and related components such as the lighting system or the smoke extraction device (if any), and becomes the first line of defense to maintain the normal operation of the overall function of the device. The spare sealing gasket (2) provided can be quickly put into use when the sealing ring is worn out or fails, ensuring that the device is always in a good sealing state, avoiding the risks of device performance degradation and cross infection caused by poor sealing. The uniquely designed fixing layer (3) is made of special materials, and according to the stress and functional characteristics of different parts, it plays a reinforcing support role in key areas such as the battery compartment and the adjustment mechanism housing, and works in coordination with the sealing ring and the spare sealing gasket to comprehensively ensure the stability of the device structure, effectively resist external force impact and wear and tear in daily use, and significantly extend the service life of the device.

[0011] Preferably, the adjusting rod (5) is a core component, and its screw structure is exquisitely designed. Through precise cooperation with specific components, the infinitely adjustable function of the size of the dilator opening is successfully realized. In clinical operation, doctors can flexibly and accurately control the degree of opening of the dilator according to the individual physiological differences of patients and the diversified medical operation needs. From routine gynecological examinations to complex surgical operations, it can provide just the right operating field of vision and space, greatly improving the accuracy and adaptability of medical operations. The adjusting nut (9) that closely matches it is highly compatible with the screw in terms of thread design. The screw position can be firmly locked by tightening the operation, ensuring that the dilator remains stable at the set angle, effectively preventing operational errors caused by loose instruments, and providing strong support for the safety and stability of the medical process.

[0012] Preferably, the upper clamp arm (6) of the present invention is scientifically optimized in shape and size according to the physiological structure of the human vagina. In the process of stretching the upper part of the vagina, it can fully meet the operating space required by the doctor for examination or surgery, and can also minimize the discomfort of the patient, reflecting the humanized design concept. The lower clamp arm (7) innovatively adopts a 110° angle design, which completely solves the problem that the traditional right-angle lower clamp is easy to interfere with the surrounding environment such as the bed. This unique design creates a wider and freer operating space for doctors, significantly improves the operating field, effectively improves the efficiency and quality of medical operations, and reduces the medical risks that may be caused by limited operations.

[0013] Preferably, the specially designed solid connection reinforcement member (10) plays a key role in the connection between the upper clamp arm and the main body of the present invention. Through advanced connection technology and reasonable structural design, the connection strength of this part is greatly enhanced, effectively preventing the separation or damage of components caused by frequent use. At the same time, combined with the use of sealing materials, a strict protective barrier is constructed to effectively prevent harmful substances such as body fluids and bacteria from invading the interior of the device, ensuring the cleanliness and hygiene of the interior of the device, maintaining the reliability and durability of the device, and ensuring the safety and hygiene of medical operations.

[0014] Preferably, the fine sealing pad (11) plays an indispensable role in the fine parts of the instrument. The fine sealing pad made of high-quality rubber or silicone, with its excellent elasticity and sealing performance, can cleverly fill the tiny gaps between the components. At key locations such as the joints of the dilator, the connections of movable parts, and the pipe interfaces, the fine sealing pad can fit tightly against the surrounding parts when under pressure to form an efficient sealing barrier. Whether it is to prevent liquid leakage from affecting the safety of electrical components, or to prevent gas escape from interfering with the smoke extraction effect (if applicable), it ensures that the instrument can work stably and normally under various complex working conditions, and effectively maintains the overall performance and hygienic safety standards of the instrument.

[0015] The present invention also provides a method for using a vaginal dilator capable of shadowless illumination for obstetrics and gynecology, which comprises the following steps:

[0016] S100. Preoperative preparation: Check the integrity of the various parts of the vaginal dilator, especially the sealing ring (1) and spare sealing pad (2) to see if they are intact, and whether the fixing layer (3) shows any signs of looseness, to ensure that the sealing and fixing performance of the instrument is good, and to avoid leakage or component displacement during use. According to the expected duration of the examination or operation, select a button battery of appropriate capacity and install it correctly in the battery compartment. During the installation process, ensure that the battery electrode is firmly connected to the internal circuit of the vaginal dilator without poor contact. After the installation is completed, turn on the lighting system, check whether the annular LED light ring is emitting light normally, and observe whether the brightness, uniformity and reflection effect of the back cover meet the requirements, to ensure that the lighting system can stably provide sufficient and uniform light during the operation or examination.

[0017] S200, Patient preparation and insertion of vaginal speculum: Assist the patient to take a suitable position, usually lithotomy position, to ensure that the patient is relaxed and in a comfortable and stable state, so as to facilitate the smooth insertion of the vaginal speculum and subsequent operations. Insert the vaginal speculum slowly and gently along the axial direction of the vagina, paying close attention to the patient's reaction during the operation to avoid discomfort or injury to the patient due to rough movements.

[0018] S300, adjustment and operation of the vaginal dilator: according to the patient's vaginal physiological condition and the examination or surgical requirements, the dilator's dilator expansion angle is precisely adjusted by rotating the adjustment nut (9) to drive the screw rod (8) to move. In this process, the internal conditions of the vagina are observed to ensure that the dilator can meet the requirements of the operating field of vision and will not be over-opened to cause unnecessary harm to the patient, and the infinite adjustment function of the adjustment rod (5) is fully utilized to achieve precise control.

[0019] Using the shadowless lighting provided by the dilator's lighting system, the doctor carefully observes the internal structure of the vagina, the condition of the mucosa, the presence of lesions, etc. During the operation, the position and angle of the dilator can be further fine-tuned as needed to ensure the comprehensiveness and accuracy of the examination or surgical operation.

[0020] S400, postoperative treatment: After the examination or surgery is completed, carefully and slowly remove the dilator to avoid secondary damage to the patient's vaginal tissue. At the same time, pay attention to keeping the dilator clean to prevent contaminants from being brought out. Remove the battery in a timely manner and classify the batteries in accordance with the medical waste disposal regulations to prevent the batteries from polluting the environment or causing safety hazards in subsequent treatment. Perform a comprehensive cleaning and disinfection of the dilator. You can use appropriate disinfectant soaking, wiping or high temperature and high pressure sterilization, focusing on cleaning the parts that come into contact with the patient and the connections between the components to ensure that any residual body fluids, bacteria and other contaminants are completely removed to ensure the hygiene and safety of the dilator for the next use. During the cleaning process, check the components again for damage or wear. If you find that the sealing ring (1) is aging, the fine sealing gasket (11) is deformed, or the splicing piece (4) is loose, etc., replace the relevant components in a timely manner to ensure that the performance of the dilator is always in good condition.

[0021] The beneficial effects of the present invention based on a vaginal dilator with shadowless lighting for obstetrics and gynecology are as follows:

[0022] 1. In terms of lighting effects, the annular LED light ring of the present invention works synergistically with the highly transparent main material of the dilator and the non-transparent inner mirror design of the back cover to produce an excellent shadowless lighting effect. Compared with the uneven light and shadow problems caused by the traditional dilator relying on external lighting, the present invention can make every corner of the vagina evenly illuminated, greatly improving the clarity of the doctor's observation. This enables doctors to more accurately identify the subtle structures and pathological conditions in the vagina during processes such as vaginal disease diagnosis and surgical operations, effectively reducing the risk of misdiagnosis and missed diagnosis caused by poor lighting, and providing strong support for precision medicine.

[0023] 2. From the perspective of structural design advantages, the 110° angle design of the lower clamp arm brings significant improvement in operational convenience. Compared with the traditional right-angle lower clamp arm, it effectively avoids interference with the surrounding environment such as the bed during operation. This creates a wider operating space and a better field of vision for doctors. Doctors can operate more flexibly and without being distracted by the fear of instrument collision, which significantly improves the efficiency and quality of the operation, reduces the operation time, and reduces the discomfort and risk of patients during examination or surgery.

[0024] 3. In terms of expansion angle adjustment, the stepless adjustment function achieved by the threaded fixing structure is of great significance. Doctors can accurately adjust the opening size of the dilator according to the individual differences of different patients, such as the physiological structure characteristics of the vagina, the special circumstances of pregnant women at different gestational ages, etc. This precise adjustment capability meets the diverse medical operation needs. Whether it is a simple gynecological routine examination or a complex gynecological and obstetric surgery, it can ensure that the dilator provides the most appropriate degree of expansion, further improving the accuracy and safety of medical operations and providing patients with better medical services.

[0025] 4. In terms of sealing and fixing performance, the sealing ring, spare sealing pad, fixing layer, fine sealing pad and solid and tight connection reinforcement parts work together to ensure the overall performance of the instrument. The sealing ring and spare sealing pad ensure the sealing of the key opening parts and related components, preventing foreign matter such as dust and body fluids from entering and possibly affecting the normal operation of the lighting system or other functional components. The fixing layer enhances the structural stability of key parts, enabling them to withstand external force impact and wear in daily use. The fine sealing pad forms an effective sealing barrier in the tiny gaps of each component to prevent liquid leakage and gas escape, ensuring that the instrument can work stably under various complex working conditions. The solid and tight connection reinforcement strengthens the strength and sealing of the connection between the upper clamp arm and the main body, improves the reliability and durability of the instrument, effectively avoids cross infection caused by loose components or poor sealing, extends the service life of the instrument, and ensures the hygienic safety of medical operations. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying creative work.

[0027] Figure 1 The overall appearance of the vaginal dilator of the present invention is shown in FIG.

[0028] Figure 2 The figure shows the angle comparison of the lower clamp arm of the present invention.

[0029] Figure 3 The figure shows a partial enlarged view of the sealing and fixing components of the present invention.

[0030] Figure 4 The figure shows the flow chart of the shadowless illumination vaginal dilator of the present invention.

[0031] The purpose, features and advantages of the present invention will be further described with reference to the accompanying drawings in conjunction with the embodiments. DETAILED DESCRIPTION

[0032] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the present invention. It should be understood that the specific implementation methods described here are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0033] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below in conjunction with the embodiments of the specification.

[0034] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein, and those skilled in the art may make similar generalizations without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0035] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The term "in one embodiment" that appears in different places in this specification does not necessarily refer to the same embodiment, nor does it refer to a separate or selective embodiment that is mutually exclusive with other embodiments.

[0036] As a preferred embodiment of the present invention, the present invention provides a vaginal dilator capable of shadowless lighting for use in obstetrics and gynecology.

[0037] 1. Materials and parts preparation

[0038] Main body material and molding: Highly transparent polypropylene or polystyrene materials are selected and the main body of the vaginal dilator is manufactured through precision injection molding. During the injection molding process, parameters such as mold temperature, injection pressure and cooling time are strictly controlled to ensure that there are no defects such as bubbles and cracks after the main body is molded, and the thickness is uniform to ensure good penetration of light. The molded main body is strictly inspected for quality, including appearance inspection, dimensional accuracy measurement and transparency test, to ensure that it meets the design requirements.

[0039] Component procurement and processing

[0040] Purchase high-quality annular LED light rings whose luminous intensity, color temperature, and stability must meet medical lighting standards. Conduct electrical performance tests on the light rings to ensure that there are no leakage, short circuits, and other problems. Design and process appropriate mounting structures based on the size and shape of the dilator's operating port, and securely fix the light ring to the operating port by bonding or embedded mounting to ensure that light is evenly distributed inside the vagina.

[0041] Customize the sealing ring (1) and spare sealing pad (2) using materials such as rubber or silicone that have high elasticity and good sealing performance. According to the size and shape of the opening of the main body of the dilator, accurately cut the sealing component to ensure that it fits tightly to the edge of the opening to achieve a good sealing effect. Perform sealing performance tests on the sealing component, such as pressure testing and liquid immersion resistance testing, to ensure that it can effectively prevent dust, body fluids, etc. from entering the interior of the device during long-term use.

[0042] The fixing layer (3) is processed by selecting suitable high-strength plastics, metal sheets or composite materials according to the requirements of different parts. The fixing layer components that meet the shape and size requirements of key parts such as the battery compartment and the adjustment mechanism housing are manufactured by cutting, stamping or injection molding. During the installation process, the fixing layer is firmly fixed to the corresponding part using an adhesive or mechanical fastening method to enhance its structural stability.

[0043] Manufacture the splicing parts (4), including nuts, bolts, clips, pins, etc. For nuts and bolts, high-precision thread processing technology is used to ensure that the thread accuracy and surface quality meet the assembly requirements. Clips and pins are formed by precision molds to ensure dimensional tolerances and fit accuracy. Strength tests and assembly tests are performed on the splicing parts to ensure that they can reliably connect and fix other parts during the assembly and adjustment of the device.

[0044] The adjusting rod (5) and the screw (8) are processed by selecting suitable metal materials and manufacturing screw parts with precise dimensions and smooth surfaces through turning, grinding and other processing techniques. The matching parts of the adjusting rod and the screw need to be finely processed to ensure smooth movement and no looseness during the adjustment process. The internal thread of the adjusting nut (9) matches the external thread of the screw and is manufactured using a thread processing process and subjected to a thread matching test to ensure the accuracy and stability of the adjustment.

[0045] The upper clamp arm (6) and the lower clamp arm (7) are manufactured, and their shapes and sizes are designed according to the physiological structure of the human vagina. The clamp arm parts are manufactured by casting or machining technology to ensure that their surfaces are smooth and have no sharp edges and corners to reduce harm to the patient. The 110° angle of the lower clamp arm must be strictly controlled during the processing, and the mold or processing equipment must be used to ensure that it meets the design requirements. The mechanical properties of the clamp arm are tested to ensure that it has sufficient strength and toughness to withstand the force of stretching the vagina.

[0046] The solid connection reinforcement member (10) is manufactured by designing and processing the reinforcement member according to the shape and structure of the connection part between the upper clamp arm and the main body. The reinforcement member is firmly connected to the connection part by welding, riveting or special connection structures (such as dovetail grooves, card slots) and other processes. At the same time, a sealing material such as a rubber sealing ring or a sealing glue is arranged between the reinforcement member and the connection part to ensure the sealing and strength of the connection part.

[0047] The fine sealing gasket (11) is manufactured by selecting rubber or silicone material and manufacturing the sealing gasket that meets the requirements of the small gap size between the components through stamping or cutting process. The fine sealing gasket is tested for elasticity and sealing performance to ensure that it can fit the gap tightly when under pressure and effectively prevent liquid leakage and gas escape.

[0048] 2. Assembly process

[0049] Preliminary assembly: The processed upper clamp arm (6) and lower clamp arm (7) are assembled with the dilator body by welding, riveting or high-strength bolt connection to ensure a firm connection and flexible opening and closing of the clamp arm. During the connection process, a solid connection reinforcement member (10) is installed to ensure the strength and sealing of the connection between the upper clamp arm and the body.

[0050] Installation of the adjustment mechanism: Install the adjustment rod (5) and the screw (8) at the corresponding position of the dilator body, ensuring that they are connected to the upper clamp arm and the lower clamp arm accurately. Install the adjustment nut (9) and conduct a preliminary adjustment test to check whether the adjustment mechanism can smoothly adjust the size of the dilator opening and ensure that the stepless adjustment function is normal.

[0051] Installation of lighting and sealing components: Install the annular LED light ring at the operation port, connect the electrical circuit, and ensure that the lighting system works properly. Install the sealing ring (1) and spare sealing gasket (2) at the opening of the dilator body, and place fine sealing gaskets (11) at key connection parts and gaps to ensure good sealing of the instrument.

[0052] Installation of fixing layer and splicing parts: The fixing layer (3) is installed on the battery compartment, the outer shell of the adjustment mechanism, etc. to enhance the structural stability. The splicing parts (4) are used to further fix and connect the various parts, such as using nuts and bolts to tighten the adjustment mechanism, and using buckles to connect detachable parts, etc., to ensure that the structure of the entire vaginal dilator is firm and reliable.

[0053] 3. Quality inspection and debugging

[0054] Appearance and structure inspection: Conduct a comprehensive appearance inspection on the assembled dilator to check whether there are any parts that are not firmly installed, surface defects, or large gaps. Check whether the markings of each component are clear and complete to facilitate subsequent use and maintenance. Check the overall structure of the dilator to ensure that the upper and lower arms open and close smoothly, the adjustment mechanism is flexible and accurate, and the lighting system is normal.

[0055] Performance Testing

[0056] Conduct a lighting performance test, turn on the lighting system in a dark environment, and check whether the brightness, uniformity, and shadow-free effect of the light meet the requirements. Use a professional light meter to measure the light intensity at different locations in the vaginal simulation cavity to ensure that the light can evenly illuminate the entire simulation cavity without obvious shadows.

[0057] Test the expansion angle adjustment performance, adjust the vaginal dilator from the minimum expansion angle to the maximum expansion angle by adjusting the nut (9), and record the hand feeling and angle change during the adjustment process. Use an angle measurement tool to measure the opening angle of the vaginal dilator at different adjustment positions to ensure that it can achieve stepless adjustment and that the angle accuracy meets the clinical use requirements.

[0058] To test the sealing performance, place the dilator in a simulated body fluid or gas environment to check for liquid leakage or gas escape. Use pressure testing equipment to apply a certain amount of pressure to the inside of the dilator to observe whether the sealing components can withstand the pressure and maintain a good sealing effect.

[0059] Disinfection and packaging: The qualified vaginal dilators are disinfected by ethylene oxide sterilization, high temperature and high pressure sterilization or ultraviolet disinfection to ensure the sterility of the instruments. After disinfection, the vaginal dilators are packaged. The packaging materials should have good moisture-proof, dust-proof and antibacterial properties. The packaging should be marked with information such as product name, specifications, production date, usage and precautions.

[0060] 4. Use and Maintenance

[0061] Preparation before use: Before using the dilator, medical staff should check whether the packaging is intact. After opening the packaging, check again whether the appearance of the dilator is damaged or contaminated. According to the estimated duration of the examination or surgery, select a button battery of appropriate capacity and install it correctly in the battery compartment, ensuring that the battery connection is firm and not loose. Turn on the lighting system and check whether the light is normal, including brightness, uniformity, and the reflection effect of the back cover.

[0062] Clinical use: Assist the patient to take a suitable body position, usually the lithotomy position. Slowly and gently insert the dilator into the vagina along the axial direction of the vagina. During the insertion process, closely observe the patient's reaction. If there is discomfort or pain, stop the operation and adjust it immediately. According to the patient's physiological condition and the needs of the examination or surgery, adjust the expansion angle of the dilator by rotating the adjustment nut (9). During the adjustment process, use the lighting system to observe the internal conditions of the vagina to ensure that the expansion angle is appropriate, which can meet the operation needs and will not cause excessive harm to the patient. During the examination or surgery, the doctor should make full use of the lighting and structural advantages of the dilator, carefully observe the internal structure of the vagina, the state of the mucosa, and the presence of lesions, and further fine-tune the position and angle of the dilator if necessary.

[0063] Post-use treatment: After the examination or surgery is completed, carefully remove the dilator from the vagina to avoid causing secondary harm to the patient. After removal, immediately remove the battery and dispose of it in accordance with the regulations for medical waste disposal. Thoroughly clean and disinfect the dilator. It can be soaked, wiped or rinsed with a suitable disinfectant, focusing on the parts that come into contact with the patient and the joints of the components. During the cleaning process, check whether the components are damaged or worn. If the sealing ring (1) is aging, the fine sealing gasket (11) is deformed, or the joint (4) is loose, the relevant components should be replaced in time. After cleaning and disinfection, the dilator should be properly stored to avoid collision or damage until the next use.

[0064] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A shadowless illumination vaginal dilator for obstetrics and gynecology, characterized in that: include: The main body of the vaginal dilator is made of a highly transparent material and is used to support and accommodate other components. The highly transparent material is polypropylene or polystyrene to ensure that light can penetrate well therein; The lighting system is arranged at the operation port of the dilator body, and includes an annular LED light ring, which is used to provide uniform lighting inside the vagina to achieve a shadowless lighting effect, and the light ring is firmly connected to the dilator body to ensure that it will not shift or loosen during use; The adjustment mechanism is used to adjust the expansion angle of the vaginal dilator, including an adjustment rod, a screw and an adjustment nut. The adjustment rod is a screw structure used to achieve infinite adjustment of the size of the vaginal dilator opening, and can meet different medical operation requirements by cooperating with specific components. The adjustment nut is tightly matched with the screw, and the screw position can be accurately locked by rotating the adjustment nut to ensure that the vaginal dilator remains stable at the set angle; The upper clamp arm, as one of the main components of the vaginal dilator, is designed in shape and size according to the physiological structure of the human vagina. It is used to open the upper part of the vagina, which can minimize the patient's discomfort during the operation and provide enough space for the doctor to perform examination or surgery. The lower forceps arm works together with the upper forceps arm to open the vagina. The lower forceps arm is designed with a 110° angle. Compared with the traditional right-angle lower forceps, this angle design effectively avoids interference with the surrounding environment such as the bed, providing doctors with a wider operating space and a better field of vision; The sealing components are distributed in key parts of the main body of the vaginal speculum, and include at least: a sealing ring, located at an opening of the main body of the vaginal speculum, made of elastic materials such as rubber or silicone, used to seal or fix the parts connected with the lighting system or other related components, to ensure the sealing and functionality of the device, and to prevent dust, body fluids, etc. from entering and affecting the normal operation of the device; The spare sealing pad is also located at the opening of the main body of the vaginal dilator. The material is similar to that of the sealing ring. As a spare part of the sealing ring, it can be replaced in time when the sealing ring is worn out or fails to maintain the sealing state of the device; Fine sealing pads are made of materials with good elasticity and sealing properties, such as rubber and silicone, and are used to fill the tiny gaps between components. They can fit tightly when under pressure to form an effective sealing barrier. They prevent liquid leakage and gas escape at key locations such as the joints, joints of movable components, and pipe interfaces of the dilator, thus ensuring the normal operation and hygienic safety of the device. The fixing layer is made of high-strength plastic, metal sheet or composite material. It is set in key areas such as the battery compartment and the outer shell of the adjustment mechanism according to the stress and functional characteristics of different parts of the vaginal dilator. It is used to reinforce and stabilize the structure, prevent deformation and displacement of components, ensure the overall structural stability of the device, and work together with the sealing component to extend the service life of the device. Splicing parts are parts used to connect or fix other parts, including nuts, bolts, clips, pins and other forms. They are selected and designed precisely according to different connection requirements. The combination of nuts and bolts is used to withstand greater tension or pressure. Clips facilitate quick assembly and disassembly and are suitable for parts that need frequent adjustment. Pins ensure precise positioning and connection accuracy in parts with less force. All splicing parts are processed with high precision to ensure that the dimensional tolerance, thread accuracy (nuts and bolts) or fit accuracy (clip, pin) meet the assembly requirements to maintain long-term and stable connection of the equipment.

2. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: The parameters of the annular LED light ring, such as the luminous intensity, color temperature and stability, meet the medical lighting standards, and the light ring is installed in an embedded manner or through a special fixing structure at the operating port of the dilator body to ensure the tightness of its connection with the dilator body. At the same time, the back cover adopts a non-light-transmissive inner mirror design, which redirects the reflected light into the vagina based on the principle of optical reflection, effectively avoiding direct light into the doctor's eyes, and creating a clear and comfortable observation environment for the doctor.

3. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: The screw of the adjusting rod adopts a precision-machined fine-pitch thread with a triangular, trapezoidal or rectangular thread shape. It is selected according to the actual force conditions and adjustment accuracy requirements of the dilator to achieve a smaller pitch and provide more precise displacement control during rotational adjustment. Combined with a reasonably designed adjusting nut, it ensures that the adjustment process is stable and precise.

4. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: The upper forceps arm and the lower forceps arm are made of materials with certain strength and toughness, such as medical-grade stainless steel or high-strength engineering plastics. Their surfaces are smooth and the transition is natural, avoiding unnecessary scratches or damage to the vaginal tissue during the stretching process. A solid and tight connection reinforcement piece is provided at the connection between the upper forceps arm and the main body. The reinforcement piece enhances the connection strength by increasing the connection thickness, welding, riveting or special connection structures (such as dovetail grooves, card slots), and is combined with sealing materials such as rubber and silicone to prevent the invasion of body fluids and bacteria. High-strength metal is combined with elastic sealing materials to take into account both strength and sealing to ensure the hygiene, safety and reliability of the instrument.

5. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: After manufacturing, the sealing ring, spare sealing gasket and fine sealing gasket in the sealing assembly are all subjected to sealing performance tests, including pressure tests, liquid immersion tests, etc., to ensure their sealing effect. During the use of the dilator, if the sealing parts are found to be aging, deformed, or other conditions that affect the sealing performance, they can be replaced conveniently and quickly.

6. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: After the fixing layer is installed to the corresponding part of the vaginal speculum, a structural stability test is carried out to simulate the external force in actual use and verify its ability to prevent deformation and displacement of components, thereby ensuring that during complex medical operations, the key parts of the vaginal speculum remain stable at all times and do not affect the normal use of the instrument.

7. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: When manufacturing the splicing parts, the threads of the nuts and bolts are processed using advanced thread cutting or rolling technology to ensure the thread accuracy and surface quality; the buckles and pins are formed using precision molds and assembly tests are carried out to ensure that they fit closely with the corresponding parts and are firmly connected. During the assembly and adjustment of the dilator, the splicing parts can reliably connect and fix other parts without loosening, falling off, or other problems.

8. The shadowless illumination vaginal dilator for obstetrics and gynecology according to claim 1, characterized in that: Before using the dilator, medical staff can select button batteries of appropriate capacity according to the type of examination or surgery and the expected duration, correctly install them in the battery compartment and ensure good connection, turn on the lighting system to check the lighting status of the light ring, and confirm that the brightness, uniformity and reflection effect of the back cover are normal; after use, the battery can be removed in time, classified and disposed of in accordance with medical waste disposal regulations, and the dilator can be thoroughly cleaned and disinfected by soaking in chemical disinfectants, high temperature and high pressure sterilization or ultraviolet irradiation to ensure that all pollutants and pathogens are removed, and check the integrity and performance of each component. If there is damage or wear, replace the relevant components in time to ensure the safety and effectiveness of the dilator's next use.

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