Novel disposable balloon device for promoting cervical maturation and dilatation

Abstract

The utility model discloses a novel disposable balloon device for promoting cervical maturation and dilatation, which relates to the technical field of medical instruments and comprises a delivery tube. The inner balloon is arranged at one end of the conveying pipe and is of a pre-folded type; the injector connector is arranged at the other end of the conveying pipe; the guide ring is arranged in the middle of the conveying pipe and located behind the inner balloon; by means of the structural design, cervical maturation can be promoted, meanwhile, the slow-release medicine films coated on the outer surfaces of the inner balloon and the outer balloon can play the pharmacological roles of resisting inflammation, inhibiting bacteria, promoting cervical maturation and the like, and due to the design of the double balloons, the conveying pipe can be prevented from sliding off.

Description

Technical Field

[0001] This utility model relates to the technical field of medical devices, and more specifically, to a novel disposable balloon device for promoting cervical ripening and dilation. Background Technology

[0002] Cervical ripening is an important physiological indicator for pregnant women before delivery, reflecting the cervix's readiness for labor. The degree of cervical ripening directly affects the smoothness of delivery. Pregnant women with good cervical ripening usually have a smoother delivery process; while pregnant women with poor cervical ripening may need to take measures to promote cervical ripening, such as using medication or mechanical dilation.

[0003] For pregnant women with immature cervixes, clinical practice often employs medication or mechanical methods to promote cervical ripening. Effective methods for promoting cervical ripening can significantly improve the success rate of labor induction. Cervical ripening is particularly important in special circumstances (such as gestational hypertension, serious maternal illness, fetal growth restriction, and oligohydramnios). An ideal method of labor induction must be safe for both mother and fetus, with a low complication rate, low cost, minimal discomfort, and a reasonable timeframe from insertion to delivery.

[0004] Previous balloon-based cervical ripening products have increased the risk of infection, and the balloons are prone to dislodgement when the cervix is ​​slightly enlarged, thus reducing their effectiveness in promoting cervical ripening.

[0005] To address the aforementioned issues, we provide a novel single-use balloon device for promoting cervical ripening and dilation.

[0006] The information disclosed above in this background section is only intended to enhance the understanding of the background section of this utility model, and therefore may include prior art that is not known to those skilled in the art. Utility Model Content

[0007] To address the problems mentioned in the background art, this utility model provides a novel disposable balloon device for promoting cervical ripening and dilation.

[0008] The present invention provides a novel disposable balloon device for promoting cervical ripening and dilation, which adopts the following technical solution:

[0009] A novel disposable balloon device for promoting cervical ripening and dilation includes a delivery tube; an inner balloon disposed at one end of the delivery tube and pre-folded; a syringe interface disposed at the other end of the delivery tube; a guide ring disposed in the middle of the delivery tube and located behind the inner balloon; and an outer balloon disposed in the middle of the delivery tube and located behind the guide ring.

[0010] Preferably, a valve is installed in the middle of the delivery tube, in front of the syringe interface, to regulate the inflow and outflow rates of gas and liquid.

[0011] Preferably, the outer surface of the inner balloon is covered with an antibacterial film.

[0012] Preferably, the antibacterial film is composed of antibiotics.

[0013] Preferably, the middle part of the delivery tube, located between the guide ring and the outer balloon, is covered with a prostaglandin film.

[0014] Preferably, the inner balloon, guide ring, outer balloon, and delivery tube are all made of silicone material.

[0015] Preferably, the inner balloon is connected to the delivery tube.

[0016] Preferably, the outer balloon is attached to the outer surface of the delivery pipe and is connected to the delivery pipe through a water inlet.

[0017] In summary, this utility model has the following beneficial technical effects:

[0018] By connecting the syringe to the syringe port of the delivery tube, aspiration is performed, and the valve is closed. The inner balloon on the delivery tube is then delivered from the vaginal opening toward the uterus. When the guide ring passes through the immature, narrow cervix, a feeling of emptiness will be felt. Then, gently pull the delivery tube outwards. Once it can be confirmed that it cannot be pulled out, it indicates that the inner balloon is completely located in the uterus. At this point, the valve is opened, and liquid is injected through the syringe port, causing the inner and outer balloons to inflate sequentially. Both the inner and outer balloons are pre-formed with a volume of approximately 30 ml. After injecting about 60 ml of liquid, a greater resistance to the liquid injection will be felt. At this point, the liquid injection is stopped, and the valve is closed. As the inner and outer balloons inflate, their increased volume compresses the cervix, accelerating cervical ripening. At the same time, the slow-release drug film coated on the outer surface of the inner and outer balloons exerts anti-inflammatory, antibacterial, and cervical ripening-promoting pharmacological effects. If premature rupture of membranes, abnormal fetal heart rate monitoring, impending labor, labor has not started for 12 hours, or cervical ripening is confirmed, open the valve to release and drain as much fluid as possible from the inner and outer balloons and delivery tube. Then remove the device from the uterus and birth canal. This structural design can promote cervical ripening. At the same time, the slow-release drug film coated on the outer surface of the inner and outer balloons can play a pharmacological role such as anti-inflammatory and antibacterial effects and promote cervical ripening. Moreover, the double balloon design can prevent the delivery tube from slipping.

[0019] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the structure of a novel disposable balloon device for promoting cervical ripening and dilation, as described in an embodiment of this utility model.

[0021] Figure 2 This is a cross-sectional schematic diagram of a novel disposable balloon device for promoting cervical ripening and dilation, as described in an embodiment of this utility model.

[0022] Figure 3 This is a schematic diagram of the internal balloon contraction structure in an embodiment of this utility model;

[0023] Figure 4 This is a schematic diagram of the internal balloon inflation structure in an embodiment of this utility model.

[0024] Explanation of reference numerals in the attached diagram: 1. Delivery tube; 2. Inner balloon; 3. Syringe interface; 4. Guide ring; 5. Outer balloon; 6. Valve; 7. Antibacterial film; 8. Prostaglandin film. Detailed Implementation

[0025] The following is in conjunction with the appendix Figures 1 to 4 The present invention will be described in further detail below.

[0026] It should be noted that the accompanying drawings are schematic and not to scale. For clarity and convenience, the relative dimensions and proportions of the parts shown are exaggerated or reduced in size; all dimensions are merely illustrative and not limiting. Furthermore, the same reference numerals are used for the same structures, elements, or fittings appearing in more than two drawings to indicate similar features.

[0027] Example 1

[0028] This utility model discloses a novel disposable balloon device for promoting cervical ripening and dilation. (See reference...) Figures 1 to 4 A novel disposable balloon device for promoting cervical ripening and dilation includes a delivery tube 1; an inner balloon 2, located at one end of the delivery tube 1 and pre-folded; a syringe interface 3, located at the other end of the delivery tube 1; a guide ring 4, located in the middle of the delivery tube 1 and behind the inner balloon 2; and an outer balloon 5, located in the middle of the delivery tube 1 and behind the guide ring 4.

[0029] The inner balloon 2 is shaped like a closed umbrella. Before being filled with water, it is under negative pressure. After being filled with water, the inner balloon 2 expands into a 30ml sphere.

[0030] The diameter of the guide ring 4 is 10-12 mm.

[0031] The length of the conveying pipe 1 is 40-60mm, the wall thickness is 1-1.5mm, and the pipe diameter is 6-8mm.

[0032] The distance between the inner balloon 2 and the outer balloon 5 is 2-3 mm.

[0033] Specifically, a valve 6 is installed in the middle of the delivery tube 1, in front of the syringe interface 3, to regulate the speed of gas and liquid inflow and outflow. By setting the valve 6, the operator can flexibly inject and drain water from the delivery tube 1, and control the water flow rate. The expansion degree of the two balloons can be gradually adjusted according to the actual situation of the cervix. It is also equipped with an emergency release mechanism to quickly remove the two balloons in case of emergency.

[0034] Specifically, the outer surface of the inner balloon 2 is covered with an antibacterial film 7.

[0035] Specifically, the antibacterial film 7 is composed of antibiotics (broad-spectrum antibiotics, mainly cephalosporins), and may also be honeysuckle dew or dandelion extract.

[0036] Specifically, the middle part of the delivery tube 1, located between the guide ring 4 and the outer balloon 5, is covered with a prostaglandin film 8.

[0037] The antibacterial film 7 and the prostaglandin film 8 are formed by spraying the drug onto the inner and outer spherical membranes through a nozzle.

[0038] Specifically, the inner balloon 2, guide ring 4, outer balloon 5, and delivery tube 1 are all made of silicone material (medical-grade silicone material).

[0039] Example 2

[0040] This embodiment is a further optimization based on the above embodiments. The parts that are the same as those in the foregoing technical solutions will not be repeated here. Figure 2 As shown, to further better realize this utility model, the following arrangement is specifically adopted: In this embodiment, the inner balloon 2 is connected to the delivery pipe 1, and the outer balloon 5 is attached to the outer surface of the delivery pipe 1 and is connected to the delivery pipe 1 through the water inlet. The inner balloon 2 is directly connected to the delivery pipe 1, and the resistance generated during expansion is small, so it expands first. The outer balloon 5 is attached to the outer wall of the delivery pipe 1 and is connected to the delivery pipe 1 through several small holes on the wall of the delivery pipe 1. The resistance generated during expansion is large, so it expands later.

[0041] The inner balloon 2 inflates first, followed by the outer balloon 5. This allows the two balloons to be positioned at the front and rear ends of the cervical canal to form a "lock" and prevent the delivery tube 1 from falling off.

[0042] All standard parts used in this utility model can be purchased from the market, and irregular parts can be customized according to the description and drawings. The specific connection methods of each part adopt conventional methods such as bolts, rivets, and welding that are mature in the existing technology. The machinery, parts and equipment adopt conventional models in the existing technology, which will not be described in detail here.

[0043] The implementation principle of this novel disposable balloon device for promoting cervical ripening and dilation is as follows: First, connect the syringe to the syringe interface 3 of the delivery tube 1. Then, aspirate and close the valve 6. Next, deliver the inner balloon 2 on the delivery tube 1 from the vaginal opening towards the uterus. When the guide ring 4 passes through the immature, narrow cervical opening, a feeling of emptiness (a sudden decrease in resistance) will be generated. Then, gently pull the delivery tube 1 outward to confirm that it cannot be pulled out (the guide ring 4 is a cone shape, with a small head and a large base, similar to...). (Similar to a barb), indicating that the inner balloon 2 is completely inside the uterus. At this point, open valve 6 and inject liquid through syringe interface 3, causing the inner balloon 2 and outer balloon 5 to inflate sequentially. Both the inner and outer balloons are pre-formed, with a volume of approximately 30 ml. After injecting about 60 ml of liquid, you will feel greater resistance. At this point, stop injecting liquid and close valve 6. As the inner and outer balloons inflate, their increased volume compresses the cervix, accelerating cervical ripening. Simultaneously, the slow-release drug film coated on the outer surface of the inner and outer balloons exerts anti-inflammatory, antibacterial, and cervical ripening-promoting pharmacological effects. If premature rupture of membranes, abnormal fetal heart rate monitoring, impending labor, labor has not started for 12 hours, or cervical ripening is confirmed, open valve 6 to release and drain as much liquid as possible from the inner and outer balloons and delivery tube 1. Then, remove the device from the uterus and birth canal.

[0044] In the description of this utility model, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. "A plurality of" means two or more, unless otherwise explicitly specified.

[0045] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," 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 communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0046] In this utility model, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0047] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0048] The accompanying drawings of the embodiments disclosed in this utility model only involve the structures involved in the embodiments disclosed in this utility model. Other structures can refer to the general design. In the absence of conflict, the same embodiment and different embodiments of the present invention can be combined with each other.

[0049] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A novel disposable balloon device for promoting cervical ripening and dilation, characterized in that, include: Delivery pipe (1); The inner balloon (2) is located at one end of the delivery tube (1) and is pre-folded; The syringe interface (3) is located at the other end of the delivery tube (1); The guide ring (4) is located in the middle of the delivery tube (1) and behind the inner balloon (2); The external balloon (5) is located in the middle of the delivery tube (1) and behind the guide ring (4).

2. The novel disposable balloon device for promoting cervical ripening and dilation according to claim 1, characterized in that: A valve (6) is installed in the middle of the delivery tube (1) in front of the syringe interface (3) to regulate the speed of gas and liquid inflow and outflow.

3. The novel disposable balloon device for promoting cervical ripening and dilation according to claim 1, characterized in that: The outer surface of the inner balloon (2) is covered with an antibacterial film (7).

4. The novel disposable balloon device for promoting cervical ripening and dilation according to claim 3, characterized in that: The antibacterial film (7) is composed of antibiotics.

5. A novel disposable balloon device for promoting cervical ripening and dilation according to claim 1, characterized in that: The middle part of the delivery tube (1), located between the guide ring (4) and the outer balloon (5), is covered with a prostaglandin film (8).

6. The novel disposable balloon device for promoting cervical ripening and dilation according to claim 1, characterized in that: The inner balloon (2), guide ring (4), outer balloon (5), and delivery tube (1) are all made of silicone material.

7. The novel disposable balloon device for promoting cervical ripening and dilation according to claim 1, characterized in that: The inner balloon (2) is connected to the delivery tube (1).

8. A novel disposable balloon device for promoting cervical ripening and dilation according to claim 1, characterized in that: The outer balloon (5) is attached to the outer surface of the delivery tube (1) and is connected to the delivery tube (1) through the water inlet.

Images