Disposable sterile hysteroscopic sheath

CN122604288APending Publication Date: 2026-08-21SICHUAN DELMONT MEDICAL EQUIPMENT CO LTD
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Patent Information

Application Number
CN202611021692.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-07-09
Publication Date
2026-08-21

AI Technical Summary

Technical Problem

[0004]针对现有技术的不足,本发明提供了一次性无菌宫腔内窥镜镜鞘,解决了现有一次性宫腔镜防护配件中保护套固定不可靠、易松脱、密封性差、贴合不佳,以及球囊凸出管壁影响插入、充气管路外置易牵拉的技术问题

Benefits of technology

1、本发明通过尾端连接件上的燕尾形凹槽与弹性圈的机械互锁结构,实现了保护套前端的绝对防脱与360°均匀密封,凹槽的轴向截面呈槽底宽度大于槽口宽度的燕尾形或梯形结构,弹性圈压入后因槽口宽度小于弹性圈截面直径而被物理限位锁止、不可脱出,凹槽槽底的环形凸筋在弹性圈压紧塑料薄膜时形成第二道线密封,与面密封构成双重密封屏障,该结构解决了现有简单弹性圈箍紧方式易滚脱移位、密封压力分布不均导致渗漏的技术难题。

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Abstract

This invention relates to the field of gynecological medical endoscopic instruments, and discloses a disposable sterile hysteroscopic endoscope sheath, comprising: an endoscope sheath tube, a flexible protective component, and an expansion component. The front end of the endoscope sheath tube is provided with a sealed transparent viewing window, and the rear end of the endoscope sheath tube is fixedly connected to a tail-end connector. The tail-end connector is integrally provided with a main endoscope channel, an independent instrument channel, and a water inlet channel with a Luer interface. A groove is formed on the outer wall of the tail end of the tail-end connector, and the axial cross-section of the groove is trapezoidal or dovetail-shaped. This invention achieves a tight fit between the protective sheath and the outer wall of the endoscope through the cooperation of a one-way suction tube and a vacuum suction device. The plastic film's sealed end is equipped with a one-way suction tube, which contains a one-way valve. After vacuuming, the one-way valve automatically shuts off to prevent air backflow. The plastic film adheres evenly to the outer surface of the endoscope body and handle under atmospheric pressure, ensuring a clear imaging field and accurate diagnosis.
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Description

Technical Field

[0001] This invention relates to the field of gynecological medical endoscope technology, specifically a disposable sterile hysteroscopic endoscope sheath. Background Technology

[0002] Hysteroscopy is a commonly used instrument in gynecological clinics for screening, diagnosing, and minimally invasively treating intrauterine lesions. Currently, most routinely used hysteroscopy endoscopes are reusable and sterile, which generally have the following drawbacks: 1. Limited application scenarios: Traditional reusable hysteroscopy equipment is sophisticated and expensive, routinely requiring use in the operating room, and each use necessitates a complete high-temperature, high-pressure, or chemical sterilization process, which is lengthy and cumbersome. In outpatient clinics with high patient volume and fast-paced treatment, reusable instruments cannot meet the needs of routine, rapid examinations. 2. High risk of cross-infection: Even after proper sterilization, reusable endoscopes still pose a risk of incomplete sterilization and residual tissue fluids in instrument gaps, leading to cross-infection. In outpatient clinics with multiple patients rotating through appointments, the mixing and misuse of instruments is prone to occur, further amplifying the risk of hospital-acquired infections. 3. The outer diameter of the traditional hysteroscopy sheath is relatively large, generally requiring mechanical dilation of the cervix, increasing patient pain and discomfort. Some examinations require hospitalization and anesthesia to be completed in the operating room, which is time-consuming, expensive, and consumes medical resources. Fourth, the few disposable intrauterine protective accessories currently on the market mostly use simple elastic rings or adhesive layers to fix the protective sleeve and the tail connector, lacking a mechanical locking structure. During use, under the action of pulling force or flushing pressure, the elastic ring is very easy to roll off or shift along the tail connector, resulting in the failure of the sterile barrier; uneven sealing pressure distribution can easily create gaps and cause liquid leakage. Fifth, some products with balloon sealing structures have the balloon directly protruding from the outer wall of the endoscope sheath. When inserted, the balloon generates additional resistance, increasing patient pain, and the balloon is easily scratched and damaged by the cervix; the inflation tubing mostly uses external soft tubing, which is easily hooked and pulled by surgical instruments during the operation, causing the balloon to accidentally shift or leak, affecting the safety of the operation.

[0003] Therefore, a disposable sterile hysteroscopic sheath is needed to solve the problems raised in the background art. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a disposable sterile hysteroscopic sheath, which solves the technical problems of unreliable fixing, easy loosening, poor sealing, and poor fit of existing disposable hysteroscopic protective accessories, as well as the balloon protruding from the tube wall affecting insertion and the external placement of the inflation tubing being easily pulled.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a disposable sterile hysteroscopic sheath, comprising: a sheath tube, a flexible protective component, and an expansion component. The sheath tube has a closed transparent viewing window at its front end, and a tail-end connector is fixedly connected to its rear end. The tail-end connector integrally comprises a main endoscope channel, an independent instrument channel, and a water inlet channel with a Luer interface. A groove is formed on the outer wall of the tail end of the tail-end connector, the axial cross-section of which is trapezoidal or dovetail-shaped, with the bottom width greater than the opening width. The flexible protective component comprises a plastic film, an elastic ring, an adhesive layer, and a one-way suction tube. One end of the plastic film is open, and the other end is closed. The open end of the plastic film is pressed into the groove by the elastic ring, and the elastic ring... The gyroscope is locked and limited by the groove opening; the closed end of the plastic film is provided with the one-way suction tube and the adhesive layer, and the one-way suction tube is provided with a one-way valve; the expansion assembly includes a receiving groove, a spherical airbag, an exhaust chamber, an air outlet, and an air inlet; at least one of the receiving grooves is opened on the outer wall of the sheath tube, the spherical airbag is embedded in the receiving groove, and the outer surface of the spherical airbag is flush with the outer surface of the sheath tube when it is not inflated; the exhaust chamber is opened inside the side wall of the sheath tube, one end of the exhaust chamber is connected to the inside of the spherical airbag, and the other end of the exhaust chamber is connected to the air inlet and the air outlet respectively; a one-way air inlet valve is provided in the air inlet; a pressure valve is provided in the air outlet; the sheath is individually sterile packaged and for single use.

[0006] Preferably, the endoscope sheath is a hollow, slender tubular structure, and the maximum outer diameter of the insertion section of the endoscope sheath used for insertion into the human uterine cavity is less than 5.5 mm.

[0007] Preferably, the groove opening edge and the groove bottom connection are provided with smooth rounded corner transition surfaces; the groove bottom is provided with multiple vent holes along the circumferential direction, the vent holes are axial venting micro-grooves, used to discharge the air in the groove when the elastic ring is pressed in.

[0008] Preferably, the outer end of the one-way suction tube is a standard Luer interface for connecting to an external vacuum pumping device; after the plastic film is evacuated through the one-way suction tube, its inner wall is tightly attached to the outer surface of the endoscope body and handle, and the adhesive layer is used to seal the closed end of the plastic film after vacuuming.

[0009] Preferably, the adhesive layer is a medical pressure-sensitive tape, the surface of which is covered with a peelable release paper.

[0010] Preferably, the air inlet and the air outlet are arranged side by side on the tail connector and distinguished by color or marking; the air inlet is a self-sealing silicone hole that automatically closes and seals after the syringe needle is pulled out; the pressure valve is a spring-reset pressure valve that opens when the needle is pressed and automatically closes when the needle is removed.

[0011] Preferably, the spherical airbag is arranged along the axial direction of the mirror sheath body, and the spherical airbag is controlled by an independent exhaust chamber and an independent air inlet and air outlet.

[0012] Preferably, the closed transparent window is an integral structure, and the entire endoscope sheath is integrally formed using medical non-metallic transparent material, with the closed transparent window and the endoscope sheath being integrally sealed together.

[0013] Preferably, the closed transparent window is an inlaid structure, the main body of the endoscope sheath is a metal tube, and the front end of the endoscope sheath is inlaid with a medical non-metallic transparent material to form the closed transparent window, and the inlaid connection is sealed and leak-free.

[0014] Preferably, the tail connector is integrally injection molded from medical plastic, and the main endoscope channel, the independent instrument channel, and the water inlet channel are independent of each other and do not cross-flow; the elastic ring is a medical silicone elastic ring, and the plastic film is made of medical transparent plastic film material; the endoscope sheath and the tail connector are sealed and fixed by ultrasonic welding or medical biological adhesive.

[0015] This invention provides a disposable sterile hysteroscopic sheath. It has the following beneficial effects: 1. This invention achieves absolute anti-detachment and 360° uniform sealing of the front end of the protective sleeve through the mechanical interlocking structure of the dovetail groove on the tail connector and the elastic ring. The axial cross section of the groove is a dovetail or trapezoidal structure with the bottom width of the groove being greater than the opening width. After the elastic ring is pressed in, it is physically limited and locked because the opening width is less than the cross-sectional diameter of the elastic ring, and cannot be detached. The annular rib at the bottom of the groove forms a second line seal when the elastic ring presses the plastic film, which, together with the surface seal, constitutes a double sealing barrier. This structure solves the technical problems of easy roll-off and displacement and uneven sealing pressure distribution leading to leakage in the existing simple elastic ring clamping method.

[0016] 2. This invention achieves a tight fit between the protective sleeve and the outer wall of the endoscope by using a one-way suction tube and a vacuum suction device. The plastic film is equipped with a one-way suction tube at the closed end and has a one-way valve inside. After vacuuming, the one-way valve automatically shuts off to prevent air backflow. The plastic film is evenly attached to the outer surface of the endoscope body and handle under atmospheric pressure, ensuring a clear imaging field and accurate diagnosis.

[0017] 3. This invention achieves flush insertion of the balloon with the outer surface of the endoscope sheath when the balloon is not inflated by using a receiving groove and a spherical balloon embedded in the receiving groove on the outer wall of the endoscope sheath. When not inflated, the outer surface of the balloon is flush with the outer surface of the endoscope sheath. The outer wall of the endoscope sheath is smooth and flat, and there is no additional resistance when it is inserted through the cervix, achieving unobstructed insertion without dilation. At the same time, it avoids the risk of the balloon being scratched and damaged by the cervix during insertion.

[0018] 4. This invention achieves precise control and prevents accidental activation of balloon inflation and deflation through a needle-type inflation and deflation design. The air inlet is equipped with a one-way air inlet valve, which inflates the balloon when the syringe needle is inserted and automatically seals it when the needle is removed. The air outlet is equipped with a spring-reset pressure valve, which expels air when the needle is inserted and presses the valve core, and automatically closes the valve when the needle is removed. The deflation speed can be precisely adjusted by controlling the pressure applied.

[0019] 5. The present invention has a simple overall structure, low cost, and strong adaptability. It does not require modification of existing non-sterile endoscopes used in clinical practice and can be used directly by fitting them in. It is individually sterile packaged and disposable, saving the cost of sterilization consumables and labor, and is suitable for large-scale use in outpatient clinics at all levels of hospitals. Attached Figure Description

[0020] Figure 1 This is an overall perspective view of the present invention; Figure 2 This is a schematic diagram of the mirror sheath tube of the present invention; Figure 3 This is a schematic diagram of the tail connector of the present invention; Figure 4 This is a schematic diagram of the closed transparent window of the present invention; Figure 5 This is a schematic diagram of the groove on the tail connector of the present invention; Figure 6 This is a schematic diagram of the exhaust chamber of the present invention; Figure 7 This is a schematic diagram of the spherical airbag of the present invention; Figure 8 This is a schematic diagram of the endoscope of the present invention located on a plastic film.

[0021] The components include: 1. Endpiece sheath; 2. Tail-end connector; 201. Main endpiece channel; 202. Independent instrument channel; 203. Water inlet channel; 3. Enclosed transparent viewing window; 4. Flexible protective assembly; 401. Elastic ring; 402. Adhesive layer; 403. One-way suction tube; 404. Plastic film; 5. Expansion assembly; 501. Receiving groove; 502. Spherical airbag; 503. Exhaust chamber; 504. Air outlet; 505. Air inlet; 6. Groove; 601. Exhaust port. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] Example 1: Please refer to the appendix. Figure 1 -Appendix Figure 8 This embodiment provides a disposable sterile hysteroscopic sheath. The sheath tube 1 adopts a non-metallic transparent one-piece structure, and a balloon 502 is provided.

[0024] like Figure 2 As shown, the endoscope sheath 1 is integrally extruded from medical transparent polycarbonate (PC) material, forming a hollow, slender tubular structure. The maximum outer diameter of the insertion section of the endoscope sheath 1 used for insertion into the uterine cavity is 5.5 mm. The front end of the endoscope sheath 1 is directly sealed during the extrusion molding process to form a closed transparent window 3. That is, the closed transparent window 3 and the endoscope sheath 1 are integral structures of the same material, with no seams or connecting interfaces between them. The closed transparent window 3 has an arc-shaped convex structure to meet the imaging requirements of endoscopes. The rear end of the endoscope sheath 1 is sealed and fixedly connected to the tail end connector 2 by ultrasonic welding.

[0025] like Figure 3 As shown, the tail connector 2 is integrally injection molded from medical-grade polycarbonate (PC) material. Internally, it is integrally equipped with a main endoscope channel 201, an independent instrument channel 202, and a water inlet channel 203 with a Luer connector. The main endoscope channel 201, independent instrument channel 202, and water inlet channel 203 are independent of each other and do not cross-flow. The inner diameter of the main endoscope channel 201 allows the endoscope to pass through; the inner diameter of the independent instrument channel 202 allows small surgical instruments such as biopsy forceps and polyp forceps to pass through; the outer end of the water inlet channel 203 integrates a standard Luer male connector for quick connection to the flushing tubing.

[0026] like Figure 5 and Figure 8 As shown, an annular groove 6 is provided on the outer wall of the tail end of the tail connector 2. The axial cross-section of the groove 6 is dovetail-shaped, and the width of the groove bottom is greater than the width of the groove opening. The groove opening edge and the groove bottom connection of the groove 6 are provided with smooth rounded corner transition surfaces to prevent the plastic film 404 from being cut during assembly. Multiple venting micro-grooves are evenly provided in the circumferential direction at the bottom of the groove 6 as vent holes 601, which are used to expel the air in the groove 6 when the elastic ring 401 is pressed in, to prevent air resistance from causing the elastic ring 401 to not be pressed in place. A ring rib is also raised in the center of the bottom of the groove 6. When the elastic ring 401 presses the plastic film 404, the ring rib and the plastic film 404 form a second line seal.

[0027] Furthermore, the flexible protective component 4 includes a plastic film 404, an elastic ring 401, an adhesive layer 402, and a one-way exhaust pipe 403. The plastic film 404 is made of medical-grade high-transparency polyurethane TPU film material. One end of the plastic film 404 is an open end, and the other end is a closed end. The open end of the plastic film 404 is fitted onto the outer wall of the tail end connector 2 and is fixed by pressing it into the groove 6 through the elastic ring 401. The elastic ring 401 is made of medical-grade silicone material, and its inner diameter in its natural state is smaller than the outer diameter of the tail end connector 2. During assembly, the elastic ring 401 is radially stretched and expanded, then crosses the groove opening of the groove 6. After its elasticity is restored, it is accommodated in the groove 6. Since the groove 6 has a dovetail-shaped structure with a wide bottom and a narrow opening, the elastic ring 401 is physically limited and locked by the groove opening and cannot be removed. The elastic ring 401 expands evenly in all directions within the space of the groove 6, pressing the edge of the open end of the plastic film 404 against and sealing it against the groove wall of the groove 6, forming a 360° surface seal without dead angles.

[0028] Specifically, the closed end of the plastic film 404 is provided with a one-way suction tube 403 and an adhesive layer 402. The one-way suction tube 403 is equipped with a one-way valve, and the outer end of the one-way suction tube 403 is a standard Luer male connector for connecting external syringes or small vacuum pumps and other vacuum suction devices. The adhesive layer 402 is a medical pressure-sensitive adhesive tape, which is arranged in a ring on the inner wall of the closed end of the plastic film 404. The surface of the adhesive layer 402 is covered with a peelable release paper. After the plastic film 404 is evacuated by the one-way suction tube 403, its inner wall is tightly attached to the outer surface of the endoscope body and handle under atmospheric pressure. After the vacuum is completed, the release paper is removed and the adhesive layer 402 is pressed together to seal the closed end of the plastic film 404.

[0029] like Figure 6 and Figure 7As shown, the expansion component 5 includes a receiving groove 501, a spherical airbag 502, an exhaust chamber 503, an air outlet 504, and an air inlet 505. An annular receiving groove 501 is provided on the outer wall of the endoscope sheath 1 near the front end. The depth of the receiving groove 501 matches the wall thickness of the spherical airbag 502. The spherical airbag 502 is a flexible annular airbag made of medical silicone material, embedded in the receiving groove 501. When the spherical airbag 502 is not inflated, its outer surface is flush with the outer surface of the endoscope sheath 1. The outer surface of the insertion section of the endoscope sheath 1 is smooth and flat without protrusions. An exhaust chamber 503 is provided inside the side wall of the endoscope sheath 1, extending axially along the endoscope sheath 1 to exhaust air. The front end of the air chamber 503 is connected to the interior of the spherical airbag 502. The rear end of the exhaust chamber 503 extends to a position near the tail connector 2 and is connected to the air inlet 505 and the air outlet 504 respectively. The air inlet 505 and the air outlet 504 are arranged side by side on the tail end face of the tail connector 2 and are distinguished by color: the air inlet is blue and the air outlet is red. The air inlet 505 is equipped with a one-way air inlet valve, which is a self-sealing silicone structure that automatically closes and seals after the syringe needle is pulled out. The air outlet 504 is equipped with a pressure valve, which is a spring-return pressure valve that remains closed in its natural state, opens when the needle is inserted into the valve core, and automatically closes after the needle is removed.

[0030] In this embodiment, the disposable sterile hysteroscopy sheath is sterilized with ethylene oxide and then sealed in a sterile dialysis paper-plastic composite bag. It is an independent sterile package for single use.

[0031] The method of using the disposable sterile hysteroscopic sheath in this embodiment is as follows: Step 1: Set up the endoscope, open the sterile packaging, and take out the sheath; the doctor holds the camera handle of the existing non-sterile endoscope and inserts the endoscope body from the closed end of the plastic film 404, passing it through the main endoscope channel 201 of the tail connector 2, and extending it into the inside of the sheath tube 1 until the endoscope lens reaches the closed transparent window 3. Then, tear off the release paper and stick the adhesive layer 402 to complete the bonding of the closed end of the plastic film 404.

[0032] Step 2: Push the elastic ring 401 backward along the outer wall of the tail connector 2 into the groove 6; after the elastic ring 401 crosses the opening of the groove 6, it regains its elasticity and is physically locked in the groove 6 by the opening of the groove 6, while the open edge of the plastic film 404 is pressed and sealed against the groove wall of the groove 6; during the pressing process of the elastic ring 401, the vent hole 601 at the bottom of the groove 6 discharges the air in the groove 6, ensuring that the elastic ring 401 is pressed in place; the annular rib at the bottom of the groove 6 and the plastic film 404 form a second line seal. Step 3: Connect the syringe or small vacuum pump to the Luer interface at the outer end of the one-way suction tube 403, start the suction, and extract the air between the plastic film 404 and the endoscope; after the suction is completed, the plastic film 404 is tightly attached to the outer surface of the endoscope body and handle under atmospheric pressure, the adhesive layer 402 is completely pressed and sealed, and the one-way valve in the one-way suction tube 403 automatically shuts off to prevent external air from flowing back into the plastic film 404.

[0033] Step 4: Insert the endoscope sheath. Insert the endoscope sheath tube 1 into the uterine cavity through the cervix without dilation. At this time, the spherical balloon 502 is not inflated, and its outer surface is flush with the outer surface of the endoscope sheath tube 1. The outer wall of the endoscope sheath tube 1 is flat and smooth, and the insertion resistance is small.

[0034] Step 5: Draw an appropriate amount of air into the syringe, insert the needle into the air inlet 505, and push the syringe through the exhaust chamber 503 to inject gas into the spherical balloon 502. After inflation, the spherical balloon 502 expands radially, protruding from the outer surface of the endoscope sheath 1 and fitting against the internal os of the cervix, sealing the gap between the endoscope sheath 1 and the cervical canal wall to prevent leakage of distending fluid. After the injection is completed, remove the needle. The one-way air inlet valve in the air inlet 505 will automatically close and seal to prevent backflow of gas. The pressure valve in the air outlet 504 will remain closed in its natural state to ensure that the gas in the balloon does not leak.

[0035] Step Six: Through the closed transparent viewing window 3, the endoscope can perform intrauterine imaging, video recording, and lesion observation; through the independent instrument channel 202, small surgical instruments such as biopsy forceps and polyp forceps can be inserted to complete minimally invasive operations such as the removal of small intrauterine polyps; through the Luer interface of the water inlet channel 203, irrigation fluid can be connected to the uterine surgical field for irrigation.

[0036] Step 7: After the surgery, insert a syringe into the air outlet 504, press the valve core of the pressure valve with the tip of the needle, the pressure valve opens, and the gas in the spherical airbag 502 is discharged through the exhaust chamber 503 and the air outlet 504. The exhaust speed can be adjusted by controlling the force of the needle pressing the pressure valve. After the spherical airbag 502 is completely retracted to be flush with the outer surface of the endoscope sheath 1, smoothly withdraw the endoscope sheath 1 from the human body and dispose of the entire endoscope sheath as medical waste.

[0037] like Figure 2 and Figure 4As shown, Example 2: This example has the same overall structural layout as Example 1, the difference being that the endoscope sheath 1 uses a metal tube with an embedded transparent window structure, and two spherical airbags 502 are arranged along the axial direction of the endoscope sheath 1. Each spherical airbag 502 is controlled by an independent exhaust chamber 503 and an independent air inlet 505 and air outlet 504; the main body of the endoscope sheath 1 is made of medical-grade 304 stainless steel or 316L stainless steel tubing. The metal tube has higher structural rigidity and bending resistance, suitable for clinical operation scenarios with complex physiological curvature of the uterine cavity and requiring a certain amount of support; the endoscope sheath 1... The front end has a pre-reserved window position, which is a circular or elliptical through hole. Medical non-metallic transparent material is processed into a transparent window piece that matches the window position. After being embedded in the window position, it is bonded and sealed with medical-grade ultraviolet curing adhesive to form a closed transparent window 3. The inlay connection is sealed to prevent liquid leakage. The outer surface of the closed transparent window 3 is flush with or slightly lower than the outer surface of the metal tube, forming a physical protective structure to prevent the window from being scratched or damaged by the cervix or surgical instruments. The rear end of the endpiece tube 1 and the tail end connector 2 are bonded and sealed with medical biocompatible adhesive.

[0038] The design and assembly methods of the tail connector 2, flexible protective component 4, groove 6 and its exhaust hole 601, annular rib, etc. in this embodiment are the same as those in embodiment 1.

[0039] Based on the above technical solution, this embodiment of the invention also provides the working principle of a disposable sterile hysteroscopic sheath, including the following: During use, the non-sterile endoscope body is inserted through the closed end of the plastic film 404 and passes through the main endoscope channel 201 of the tail connector 2, extending into the sheath tube 1; the elastic ring 401 is pressed into the dovetail-shaped groove 6 at the tail end of the tail connector 2, the groove opening limits and locks the elastic ring 401, and simultaneously presses and seals the open edge of the plastic film 404 against the groove wall of the groove 6, achieving a mechanical locking seal at the front end; then, the air inside the plastic film 404 is extracted through a vacuum extraction device connected to the one-way extraction tube 403, using atmospheric pressure to make the plastic film 404... The membrane 404 fits tightly against the outer wall of the endoscope, achieving sterile isolation. When the endoscope sheath 1 is inserted into the uterine cavity, the balloon 502, embedded in the receiving groove 501 and not inflated, is flush with the outer surface of the endoscope sheath 1, enabling unobstructed insertion without dilation. When it is necessary to seal the cervix, the balloon 502 is inflated through the air inlet 505 and the air outlet 503 by inserting the syringe needle. After the balloon 502 expands, it fits against the internal cervical os to seal the gap and prevent leakage of distending fluid. After the operation, the pressure valve is pressed by inserting the syringe needle into the air outlet 504. The gas in the balloon 502 is discharged in a controlled manner through the air outlet 503 and the air outlet 504. After the balloon 502 retracts, the endoscope sheath 1 is smoothly withdrawn.

[0040] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A disposable sterile hysteroscopic sheath, characterized in that, include: The scope comprises a sheath tube (1), a flexible protective assembly (4), and an expansion assembly (5). The front end of the sheath tube (1) is provided with a closed transparent window (3), and the rear end of the sheath tube (1) is fixedly connected to a tail end connector (2). The tail end connector (2) is integrally provided with a main scope channel (201), an independent instrument channel (202), and a water inlet channel (203) with a Luer interface. The outer wall of the tail end of the tail end connector (2) is provided with a groove (6), and the axial cross section of the groove (6) is trapezoidal. Or dovetail-shaped, with the bottom width of the groove being greater than the opening width; the flexible protective component (4) includes a plastic film (404), an elastic ring (401), an adhesive layer (402), and a one-way exhaust pipe (403); one end of the plastic film (404) is an open end and the other end is a closed end, the open end of the plastic film (404) is pressed into the groove (6) by the elastic ring (401), and the elastic ring (401) is limited and locked by the opening of the groove (6); the closed end of the plastic film (404) The device includes a one-way suction pipe (403) and an adhesive layer (402), with a one-way valve inside the one-way suction pipe (403); the expansion assembly (5) includes a receiving groove (501), a spherical airbag (502), an exhaust chamber (503), an air outlet (504), and an air inlet (505); at least one receiving groove (501) is provided on the outer wall of the sheath tube (1), and the spherical airbag (502) is embedded in the receiving groove (501). The spherical airbag (502) in its uninflated state... The outer surface is flush with the outer surface of the sheath tube (1); the exhaust chamber (503) is provided inside the side wall of the sheath tube (1), one end of the exhaust chamber (503) is connected to the interior of the spherical airbag (502), and the other end of the exhaust chamber (503) is connected to the air inlet (505) and the air outlet (504) respectively; a one-way air inlet valve is provided in the air inlet (505); a pressure valve is provided in the air outlet (504); the sheath is individually sterile packaged and used only once.

2. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The endoscope sheath (1) is a hollow, slender tubular structure, and the maximum outer diameter of the insertion section of the endoscope sheath (1) used for insertion into the human uterine cavity is less than 5.5 mm.

3. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The groove (6) has a smooth rounded corner transition surface at the groove edge and the groove bottom connection; the groove (6) has multiple exhaust holes (601) along the circumferential direction at the groove bottom, and the exhaust holes (601) are axial air venting micro-grooves used to discharge the air in the groove (6) when the elastic ring (401) is pressed in.

4. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The outer end of the one-way suction tube (403) is a standard Luer interface for connecting to an external vacuum pumping device; after the plastic film (404) is evacuated by the one-way suction tube (403), its inner wall is tightly attached to the outer surface of the endoscope body and handle; the adhesive layer (402) is used to seal the closed end of the plastic film (404) after evacuation.

5. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The adhesive layer (402) is a medical pressure-sensitive tape, the surface of which is covered with a peelable release paper.

6. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The air inlet (505) and the air outlet (504) are arranged side by side on the tail connector (2) and are distinguished by color or markings; the air inlet (505) is a self-sealing silicone hole that automatically closes and seals after the syringe needle is pulled out; the pressure valve is a spring-reset pressure valve that opens when the needle is pressed and automatically closes after the needle is removed.

7. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The spherical airbag (502) is arranged along the axial direction of the mirror sheath tube (1), and the spherical airbag (502) is controlled by the independent exhaust chamber (503), the independent air inlet (505), and the air outlet (504).

8. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The closed transparent window (3) is an integral structure. The endoscope sheath (1) is integrally formed using medical non-metallic transparent material. The closed transparent window (3) and the endoscope sheath (1) are integrally closed.

9. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The closed transparent window (3) is an inlaid structure. The main body of the endoscope sheath tube (1) is a metal tube. The front end of the endoscope sheath tube (1) is inlaid with a medical non-metallic transparent material to form the closed transparent window (3). The inlaid connection is sealed and leak-free.

10. The disposable sterile hysteroscopic sheath according to claim 1, characterized in that, The tail connector (2) is made of medical plastic through injection molding. The main endoscope channel (201), the independent instrument channel (202) and the water inlet channel (203) are independent of each other and do not cross-flow. The elastic ring (401) is a medical silicone elastic ring and the plastic film (404) is made of medical transparent plastic film. The endoscope sheath (1) and the tail connector (2) are sealed and fixed by ultrasonic welding or medical biological adhesive.