A round table type anti-reflux injection tube for uterine cavity injection

Abstract

This invention relates to the field of intrauterine injection tools, specifically disclosing a frustum-shaped anti-reflux injection tube for intrauterine injection. The tube includes a second injection tube, with a flexible, fluid-blocking plug fixed to its outer wall. The fluid-blocking plug is shaped like a frustum adapted to the cervix, and an elastic rubber sleeve is fixed to its outer wall to cover the cervical os. This frustum-shaped anti-reflux injection tube for intrauterine injection achieves a seal simply by inserting the fluid-blocking plug into the cervical canal, without needing to enter the uterine cavity. This fundamentally avoids the mechanical pressure on the uterine wall and cervical os caused by the inflation of a balloon within the uterine cavity, as seen in existing technologies. Furthermore, the fluid-blocking plug's frustum-shaped design, with a thinner front and thicker back, allows for a smooth transition between the smaller end and the outer wall of the injection tube. Combined with the flexible medical material, the insertion process involves minimal resistance, resulting in only a slight soreness for the patient. This effectively solves the problem of significant pain and intolerance for some patients caused by balloon compression in existing balloon-type injection tubes.

Description

Technical Field

[0001] This invention relates to the field of intrauterine injection tools, specifically a frustum-shaped anti-reflux injection tube for intrauterine injection. Background Technology

[0002] In gynecological clinical diagnosis and treatment, the intrauterine injection catheter is a core instrument for delivering medications, contrast agents, and other fluids into the uterine cavity. Currently, the most widely used type in clinical practice is the balloon-type intrauterine injection catheter, whose typical structure is shown in Figures 1 and 5: it mainly includes a first injection tube 1, a trachea 2, and a balloon 3. The first injection tube 1 has a double-layered coaxial structure; the inner layer is the main injection channel for delivering fluid, and the outer layer is an inflation channel (trachea 2) connected to the balloon 3. The balloon 3 is fixedly installed at the front end of the first injection tube 1. During use, the front end of the first injection tube 1, along with the balloon 3, is inserted into the uterine cavity. Air or saline solution is injected into the balloon 3 through the trachea 2 to inflate it. The inflated balloon 3 seals the internal cervical os, thereby preventing fluid from flowing back from the uterine cavity into the vagina, ensuring the smooth execution of the injection or contrast procedure.

[0003] However, existing balloon-type intrauterine injection catheters have many insurmountable drawbacks in clinical use: Patients experience intense pain: Balloon 3 must be fully inserted into the uterine cavity before it can be inflated. Once inflated, Balloon 3 directly compresses the uterine wall and the internal cervical os. Because the uterine muscle layer is extremely sensitive to mechanical pressure, this compression causes significant lower abdominal distension and pain. Some patients have poor tolerance and may even be unable to complete the examination or treatment, severely impacting their experience.

[0004] Artifacts can easily interfere with imaging observation and increase diagnostic difficulty: In procedures requiring imaging assistance, such as hysterosalpingography (HSG) and hysteroscopic ultrasound, the inflated balloon 3 and the fluid outlet of the first injection tube 1, which extends deep into the uterine cavity, will both create obvious artifacts on the images. If the balloon is over-inflated or placed too deeply, its upward bulging portion will obscure the lesion area on the uterine cavity wall; even if the balloon is in a normal position, the acoustic shadowing or imaging artifacts it produces will affect the doctor's observation of the lower uterine segment and the internal cervical os, increasing the risk of missed or misdiagnosis and reducing diagnostic accuracy.

[0005] The complex structure, cumbersome manufacturing process, and excessively large tube diameter of existing balloon injection tubes, in order to simultaneously achieve liquid delivery and balloon inflation, necessitate a double-layer coaxial or double-tube parallel structure. This requires an additional independent air tube 2 outside the main injection tube, with both forming the first injection tube 1. This structure not only significantly increases the complexity and production cost of mold design, injection molding, bonding, and sealing processes, but also results in a large overall diameter of the first injection tube 1. The thicker tube further increases patient discomfort when passing through the cervical canal and limits its application in special patients with cervical stenosis, cervical adhesions, etc.

[0006] There are potential safety risks: the inflation volume of balloon 3 is difficult to control precisely. Insufficient inflation can lead to poor sealing of the internal cervical os, resulting in leakage of medication and reflux of contrast agent, affecting the treatment outcome. Over-inflation, on the other hand, can increase uterine pressure and may even lead to serious complications such as uterine perforation and cervical laceration. In addition, balloon 3 is also at risk of rupture and leakage, which would directly cause the seal to fail, forcing the interruption of the treatment procedure.

[0007] In summary, existing balloon-type intrauterine injection catheters suffer from significant patient discomfort, interfere with imaging diagnosis, have complex structures, high manufacturing costs, and pose numerous safety risks, failing to meet clinical demands for safe, comfortable, and efficient intrauterine injection devices. Therefore, developing a novel intrauterine injection catheter that fundamentally addresses these shortcomings is of significant clinical importance. Summary of the Invention

[0008] The purpose of this invention is to provide a frustum-shaped anti-reflux injection tube for intrauterine injection, so as to solve the problems mentioned in the background art.

[0009] To achieve the above objectives, the present invention provides the following technical solution: a frustum-shaped anti-reflux injection tube for intrauterine injection, comprising a second injection tube, wherein a fluid-blocking plug made of flexible material is fixedly connected to the outer wall of the injection tube, wherein the fluid-blocking plug is configured in a frustum shape adapted to the cervix, and an elastic rubber sleeve that can cover the cervical opening is fixedly connected to the outer wall of the fluid-blocking plug.

[0010] Preferably, the sleeve is made of elastic silicone.

[0011] Preferably, the distance from the connection between the liquid-blocking plug and the rubber sleeve to the outlet of the second injection tube is no more than 4 cm.

[0012] Preferably, the injection end of the second injection tube is provided with an injection connector, and a one-way valve is provided on the inner side of the injection connector.

[0013] Preferably, the liquid-blocking plug is made of medical-grade silicone or medical-grade natural rubber in one piece, with a Shore hardness of 30-50HA.

[0014] Compared with existing technologies, the beneficial effects of this invention are as follows: This frustum-shaped anti-reflux injection tube for intrauterine injection only needs to be inserted into the cervical canal to achieve a seal, without needing to enter the uterine cavity. This fundamentally avoids the mechanical pressure on the uterine wall and internal cervical os caused by the inflation of the balloon within the uterine cavity, as is present in existing technologies. Simultaneously, the anti-reflux plug adopts a frustum-shaped design that is thinner at the front and thicker at the back, with a smooth transition between the small end and the outer wall of the injection tube. Combined with flexible medical materials, the insertion process involves minimal resistance, and patients only experience a slight soreness. This effectively solves the problem of significant pain and intolerance for some patients caused by balloon compression in existing balloon-type injection tubes.

[0015] The injection tube outlet is located only at the junction of the internal cervical os and the uterine cavity, fundamentally eliminating the artifacts caused by the balloon and the injection tube tip extending deep into the uterine cavity in existing technologies. This avoids the problems of uterine cavity lesions being obscured by excessive balloon inflation or excessively deep placement, and also avoids the influence of acoustic shadowing or contrast artifacts caused by the balloon in its normal position on the observation of the lower uterine segment and internal cervical os area, reducing the risk of missed diagnoses and misdiagnoses.

[0016] Meanwhile, the single-tube integrated structure eliminates the need for double-layer coaxial or double-tube parallel structures found in existing technologies, saving on additional inflation tubing and significantly simplifying production processes such as mold design, injection molding, and bonding sealing, thus reducing manufacturing costs. Furthermore, the smaller overall diameter of the tube further reduces stimulation to the patient when passing through the cervical canal, making it suitable for special patients with conditions such as cervical stenosis and cervical adhesions, where traditional balloon-type injection tubes are difficult to use.

[0017] This method eliminates the need for balloon inflation and deflation, completely avoiding safety issues such as poor sealing, uterine compression damage, balloon rupture, and air leakage caused by the difficulty in controlling balloon inflation in existing technologies. A first seal is formed by the frustum-shaped liquid-resistant plug adhering to the inner wall of the cervical canal, followed by a second seal formed by an elastic rubber sleeve clamping the external os of the cervix. These two seals work together to effectively prevent leakage of medication and reflux of contrast agent, ensuring smooth diagnostic and treatment procedures. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of a conventional balloon injection tube; Figure 2 This is a schematic diagram of the liquid-blocking plug in a preferred embodiment of the present invention; Figure 3 This is a schematic diagram of the structure before the rubber sleeve is attached in a preferred embodiment of the present invention; Figure 4 This is a schematic diagram of the structure after the rubber sleeve is connected in a preferred embodiment of the present invention; Figure 5 This is a schematic diagram of the injection tube in a uterine model when using a balloon injection tube. Figure 6 This is a schematic diagram showing the insertion of the liquid-resistant plug into the cervix when using this invention; Figure 7 This is a schematic diagram showing the rubber sleeve being flipped over and placed on the outside of the cervix when using the present invention.

[0019] In the diagram: 1. First injection tube, 2. Trachea, 3. Balloon, 4. Second injection tube, 5. Liquid-blocking plug, 6. Injection connector, 7. Rubber sleeve, 8. Uterine model. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to Figures 1-7. Obviously, the described embodiments are only some preferred 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.

[0021] This embodiment discloses a frustum-shaped anti-reflux injection tube for intrauterine injection, such as... Figure 2-4 As shown, the overall structure is a single-tube integrated unit, with the core consisting of a second injection tube 4, a frustum-shaped liquid-blocking plug 5, an injection connector 6, and an elastic rubber sleeve 7. Among them: The second injection tube 4 is made of medical-grade PVC material through extrusion molding, with an inner diameter of 2.0 mm, an outer diameter of 3.2 mm, and a total length of 22 cm. The inner wall is smooth and burr-free, ensuring smooth liquid delivery. The tube has appropriate rigidity and flexibility, which can be smoothly inserted into the cervical canal without causing blockage of the lumen due to excessive bending.

[0022] The liquid-blocking plug 5 is made of medical-grade silicone with a Shore hardness of 35HA and is integrally injection molded with the second injection tube 4 on the same axis. There are no seams at the connection surface between the two, eliminating the risk of detachment and contamination. The liquid-blocking plug 5 is shaped like a frustum to fit the cervical canal of an adult woman. The small end has a diameter of 4.0mm and a smooth transition with the outer wall of the second injection tube 4 using an arc of R2.0mm, without any steps or protrusions, ensuring smooth insertion without jamming. The large end has a diameter of 2.2cm and an axial height of 2.8cm. The outer wall of the liquid-blocking plug 5 is evenly provided with two annular anti-slip sealing protrusions along the circumference. Each protrusion is 0.15cm high and 0.2cm wide, and the edges of the protrusions are rounded to enhance the friction and sealing effect with the inner wall of the cervical canal without increasing the insertion resistance due to excessive protrusion.

[0023] The elastic sleeve 7 is made of medical-grade high-elasticity silicone and is heat-pressed to the outer wall of the large end of the liquid-blocking plug 5. In its natural state, the inner diameter is equal to the diameter of the large end of the liquid-blocking plug 5. After stretching, the maximum inner diameter can reach 4.0cm. The sleeve 7 has a freely set elastic collar, which makes it easy for doctors to clamp and operate with forceps. The inner and outer surfaces of the sleeve 7 are coated with an 8μm thick medical-grade hydrophilic polyethylene glycol lubricating coating, which is slippery when wet and reduces friction with cervical tissue when flipping the sleeve.

[0024] The distance from the connection point of the liquid-blocking plug 5 and the rubber sleeve 7 to the outlet of the second injection tube 4 is 3.0 cm, ensuring that after the liquid-blocking plug 5 is fully inserted into the cervical canal, the outlet is located at the junction of the internal cervical os and the uterine cavity, without needing to penetrate deep into the uterine cavity.

[0025] The injection end of the second injection tube 4 is fixedly connected to a standard 6:100 taper Luer cone injection connector 6. A duckbill-type check valve is provided on the inner side of the connector, with an opening pressure of 0.8 kPa, which can prevent liquid backflow during injection. The outer end of the connector is equipped with a detachable sterile threaded protective cap to ensure sterility before use.

[0026] The outer wall of the second injection tube 4 is provided with a depth scale mark along the axial direction. The starting point of the scale is the connection between the liquid-blocking plug 5 and the rubber sleeve 7. The scale range is 0-4cm and the graduation value is 0.5cm, which helps doctors to accurately control the insertion depth.

[0027] The clinical usage method of this embodiment, combined with Figure 5-7 A detailed explanation is provided (where number 8 represents the uterine model), used to demonstrate the relative position of the injection tube and the uterus. The specific steps are as follows: Preoperative preparation: Remove the sterile packaging of the product, remove the protective cap of the injection connector 6, use a syringe to draw a small amount of normal saline to flush the lumen of the second injection tube 4, expel the air in the tube, and confirm that the tubing is patent before use; the patient is placed in the standard lithotomy position, the vulva, vagina and external os of the cervix are routinely disinfected, a sterile drape is placed, and the cervix is ​​exposed and fixed with a vaginal speculum.

[0028] Insert the liquid-resistant plug: such as Figure 6 As shown, the doctor holds the rear end of the second injection tube 4, aligns the small end of the liquid-blocking plug 5 with the external os of the cervix, and slowly rotates it along the axial direction of the cervical canal until the scale indicates an insertion depth of 2.8cm (i.e., the liquid-blocking plug 5 is completely inside the cervical canal). Because the small end of the liquid-blocking plug 5 smoothly transitions to the tube body, and the overall shape is a frustum that is thinner at the front and thicker at the back, the resistance during insertion is minimal, and the patient will only feel a slight soreness; at this time, the outer wall of the frustum-shaped liquid-blocking plug 5 fits tightly against the inner wall of the cervical canal, and the two sealing ridges form a sealing barrier, effectively preventing the liquid from flowing back from the cervical canal.

[0029] Flip-on elastic rubber sleeve: such as Figure 7As shown, the doctor holds a hemostat and clamps the circular flaps on both sides of the free end of the rubber sleeve 7. First, one side of the rubber sleeve 7 is gently folded from the outer wall of the liquid-blocking plug 5 towards the outside of the cervix, so that it covers one edge of the external os of the cervix. Then, the other side of the rubber sleeve 7 is folded in the same way, until the entire rubber sleeve 7 is completely folded over the outside of the external os of the cervix. The elastic recoil force of the rubber sleeve 7 tightly binds the cervix, forming a second line of defense. The two seals work together to completely prevent leakage of the medication, and the entire sealing process is completed only in the cervical canal and the external os of the cervix, with no parts entering the uterine cavity.

[0030] Injection / Iconography Procedure: Connect the injection connector 6 to the syringe and slowly inject the medication or contrast agent. Since the outlet of the second injection tube 4 is located only at the internal cervical os, the fluid can naturally flow into the uterine cavity and diffuse into both fallopian tubes without generating local high pressure. Furthermore, since there are no foreign objects in the uterine cavity, no artifacts will be produced during hysterosalpingography or intrauterine ultrasound examinations. The doctor can clearly observe the entire area of ​​the uterine cavity wall and the openings of both fallopian tubes, ensuring diagnostic accuracy.

[0031] Postoperative removal: After the operation is completed, first disconnect the connection between the injection connector 6 and the syringe, then use hemostatic forceps to clamp the folded edge of the rubber sleeve 7 and flip it back into place from the outside of the cervix. Finally, slowly pull out the second injection tube 4 along the axis. The entire removal process is without pulling or jamming, and the patient experiences very little discomfort.

[0032] In the description of this invention, it should be understood that the terms "coaxial," "bottom," "one end," "top," "middle," "other end," "upper," "one side," "outer," "inner," "front," "center," "both ends," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0033] Furthermore, the terms "first," "second," "third," and "fourth" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first," "second," "third," or "fourth" may explicitly or implicitly include at least one of those features.

[0034] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "setting," "connection," "fixing," "screw connection," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal connection of two components or the interaction between two components. Unless otherwise explicitly limited, those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0035] 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 frustum-shaped anti-reflux injection tube for intrauterine injection, characterized in that: Includes a second injection tube (4), the outer wall of which is fixedly attached with a liquid-blocking plug (5) made of flexible material, wherein the liquid-blocking plug (5) is configured in a frustum shape that fits the cervix, and the outer wall of the liquid-blocking plug (5) is fixedly attached with an elastic rubber sleeve (7) that can be flipped over and fitted onto the external opening of the cervix.

2. The frustum-shaped anti-reflux injection tube for intrauterine injection according to claim 1, characterized in that: The sleeve (7) is made of elastic silicone.

3. The frustum-shaped anti-reflux injection tube for intrauterine injection according to claim 1, characterized in that: The distance from the connection between the liquid-blocking plug (5) and the rubber sleeve (7) to the outlet of the second injection tube (4) is no more than 4cm.

4. A frustum-shaped anti-reflux injection tube for intrauterine injection according to claim 1, characterized in that: The second injection tube (4) is provided with an injection connector (6) at the injection end, and a one-way valve is provided on the inner side of the injection connector (6).

5. A frustum-shaped anti-reflux injection tube for intrauterine injection according to claim 1, characterized in that: The liquid-blocking plug is integrally molded from medical-grade silicone or medical-grade natural rubber, with a Shore hardness of 30-50HA.

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