Uterine cavity anchoring spike balloon

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a uterine cavity anchoring spike balloon, which comprises a balloon, a connecting pipe, a flow guide pipe and an outer wrapping pipe. The balloon is in communication with the connecting pipe, and the connecting pipe is in communication with an external water injection device. The flow guide pipe is arranged in the balloon and the end of the flow guide pipe extends out of the balloon. The end of the flow guide pipe extending out of the balloon is provided with a flow guide opening. The outer wrapping pipe is wrapped outside the connecting pipe and the flow guide pipe. The balloon outer wall is provided with a plurality of spikes. When the balloon is inflated, the included angle between the center line of the spike and the balloon outer wall is 45-55 degrees, and the top end of the spike is arranged towards the cervical orifice. The application can avoid balloon slippage and the risk of infection caused by multiple implantations. Meanwhile, the flow guide pipe is prevented from being blocked.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a uterine cavity anchoring puncture balloon. Background Technology

[0002] Postpartum hemorrhage is a serious complication of childbirth, mainly occurring in three periods: from the time of fetal delivery to the time of placental delivery, from placental delivery to 2 hours postpartum, and from 2 hours to 24 hours postpartum. Because the bleeding point is located within the uterine cavity, this type of bleeding is characterized by rapid bleeding, large blood volume, diffuse bleeding points, difficulty in exposure, and inability to stop the bleeding under direct vision. Therefore, tools are needed for rapid hemostasis. Balloon tamponade is one of the effective methods for stopping postpartum (postoperative) hemorrhage and is now widely used in clinical practice. After balloon tamponade is applied to the uterine cavity, it can be filled with 200-500 ml of fluid to achieve the purpose of compressing the uterine cavity to stop bleeding.

[0003] Current intrauterine balloon techniques mainly consist of a guide tube and a balloon. The balloon passes through the guide tube, which is used for drainage of blood within the uterine cavity. The balloon's surface is a smooth sphere, and with the lubrication of blood and residual amniotic fluid, the following problems are highly likely to occur:

[0004] 1. After being placed in the appropriate position and inflated with water, the balloon may detach naturally due to its smooth surface and tendency to deform, requiring multiple repositionings, which delays hemostasis and increases the risk of infection.

[0005] 2. After the balloon is placed and inflated with water, it is easy for it to fall out into the lower segment of the uterus and fail to compress the uterine cavity;

[0006] 3. To prevent the balloon from dislodging, gauze is often packed into the vagina, which can easily lead to forgetting to remove it and the possibility of secondary infection. Furthermore, the gauze may not be properly secured; it only prevents the balloon from slipping out of the vagina.

[0007] 4. The opening at the tip of the balloon is small, making it easy for small blood clots formed during uterine bleeding to become blocked.

[0008] Existing technology CN109805975B discloses a uterine balloon device for real-time pressure monitoring and control. This uterine balloon device includes a first inflatable balloon, a second inflatable balloon, a first inflation tube, a second inflation tube, a liquid outlet tube, an outer tube, and two pressure gauges. The outer tube wraps around the first inflation tube, the second inflation tube, and the liquid outlet tube. The outlet of the first inflation tube is in fluid communication with the first inflatable balloon, and the outlet of the second inflation tube is in fluid communication with the second inflatable balloon. The front end of the outer tube passes sequentially through the second inflatable balloon and the first inflatable balloon. The two pressure gauges are respectively connected to the rear inflation ports of the first and second inflation tubes. This uterine balloon device prevents the first inflatable balloon from dislodging by placing the second inflatable balloon at the cervix. However, because the surface of the second inflatable balloon is also smooth, the fixation effect is limited, and it cannot completely prevent the movement of the first inflatable balloon, which may lead to delayed hemostasis. Summary of the Invention

[0009] In order to solve at least one of the above-mentioned technical problems in the prior art, the present invention provides a uterine cavity anchoring puncture balloon.

[0010] To achieve the above objectives, the technical solution of the present invention is as follows:

[0011] A uterine cavity anchoring protrusion balloon includes a balloon, a connecting tube, a drainage tube, and an outer casing. The balloon is connected to the connecting tube, which is connected to an external water injection device. The drainage tube passes through the balloon, with its end extending out of the balloon. A drainage port is provided at the end of the drainage tube extending out of the balloon. The outer casing wraps around the connecting tube and the drainage tube. A plurality of protrusions are provided on the outer wall of the balloon. When the balloon is inflated, the angle between the center line of the protrusions and the outer wall of the balloon is 45°-55°, and the tips of the protrusions face the cervix.

[0012] Furthermore, the spike is hollow inside, and its internal space communicates with the inside of the balloon.

[0013] Furthermore, the cross-sectional area of ​​the spike gradually decreases from the outer wall of the balloon outwards.

[0014] Furthermore, the spikes are triangular pyramidal in shape, and the tips of the spikes are arc-shaped.

[0015] Furthermore, the radius R of the tip arc of the spike is 2-5 mm.

[0016] Furthermore, the height of the spike is 10-20 mm.

[0017] Furthermore, the spikes are distributed on the side and lower surfaces of the balloon.

[0018] Furthermore, the spacing between adjacent spikes gradually increases from the side surface to the bottom surface; and the ratio of the spike's height to its bottom diameter gradually decreases from the side surface to the bottom surface.

[0019] Furthermore, the spacing between the spikes in the uppermost row on the lateral surface of the balloon is A, which is 18mm-30mm; extending from the lateral surface to the lower surface, A gradually increases in proportion a every two rows of spikes.

[0020] The proportion a is:

[0021]

[0022] In the above formula, d represents the center distance between the top row of spikes on the side surface and the current spike, where the current spike is the spike whose spacing is to be adjusted; D is the center distance between the top row of spikes on the side surface of the balloon and the bottom row of spikes on the lower surface.

[0023] Furthermore, the spikes in adjacent rows are staggered.

[0024] Furthermore, the angle between the centerline of the spike and the outer wall of the balloon gradually increases from the side surface of the outer wall of the balloon towards the lower surface.

[0025] Furthermore, the angle between the center line of the uppermost row of spikes on the lateral surface of the balloon and the outer wall of the balloon is 45°. Extending from the lateral surface to the lower surface, the angle gradually increases with a ratio b every two rows of spikes, where the ratio b is 0.5°-1.5°.

[0026] Furthermore, the length of the guide port is 5-7mm and the width is 5-7mm.

[0027] Furthermore, a valve is installed on the connecting pipe.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The intrauterine anchoring spike balloon provided by this invention has multiple spikes on its outer wall. These spikes expand with the balloon, and the angle between the spikes and the outer wall of the balloon is 45°-55°, with the spike tips pointing towards the cervix. Therefore, when the intrauterine anchoring spike balloon is placed in the postpartum uterine cavity, the expanded spikes can penetrate deep into the depressions of the uterine cavity, thus anchoring it to the uneven surface of the uterine cavity and preventing the balloon from falling off. Furthermore, the balloon can compress the depressions of the uterine cavity, resulting in more effective compression and improved hemostasis. Once the balloon is fixed, repeated repositioning is unnecessary, reducing the risk of infection. It also eliminates the need for vaginal packing with gauze, further reducing the risk of infection. Attached Figure Description

[0030] Figure 1 This is a structural schematic diagram of an embodiment of the present invention.

[0031] Figure 2 This is a schematic diagram of the cross-sectional structure of the spike.

[0032] Explanation of reference numerals in the attached figures:

[0033] 1-Balloon, 2-Connecting tube, 3-Drainage tube, 4-Outer tube, 5-Spike, 6-Valve. Detailed Implementation

[0034] The technical solution of the present invention will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are not all embodiments of the present invention. All other embodiments obtained by those skilled in the art without creative effort are within the protection scope of the present invention.

[0035] It should be noted that, unless otherwise specifically stated, the relative arrangement and numerical expressions of the components and steps described in these embodiments should not be construed as limiting the scope of the invention.

[0036] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.

[0037] This invention provides a uterine cavity anchoring spur balloon, such as Figure 1 and Figure 2 As shown, the device includes a balloon 1, a connecting tube 2, a guide tube 3, and an outer tube 4. The balloon 1 is connected to the connecting tube 2, and the connecting tube 2 is connected to an external water injection device. The guide tube 3 passes through the balloon 1, with its end extending out of the balloon 1. Figure 1 The upper end of the balloon 1 is provided with a drainage port; the outer tube 4 is wrapped around the outside of the connecting tube 2 and the drainage tube 3; a number of spikes 5 are provided on the outer wall of the balloon 1; when the balloon 1 is inflated, the angle f between the center line of the spikes 5 and the outer wall of the balloon 1 is 45°-55° and the tip of the spikes 5 is facing the cervix.

[0038] The spike 5 is hollow inside, and its internal space communicates with the inside of the balloon 1. That is, when water is filled into the balloon 1, the internal space of the spike 5 will also fill with water, causing the spike 5 to bulge. The water injected into the balloon 1 and the spike 5 is physiological saline.

[0039] When using the intrauterine anchoring spike balloon provided by this invention, the balloon 1 is placed into the uterine cavity, and then physiological saline is flushed into the balloon 1 to inflate it. The spike 5 communicates with the balloon 1 and is also filled with physiological saline, causing the spike 5 to bulge as the balloon 1 inflates. Because the uterine cavity wall is uneven and has many depressions after childbirth, the bulging spike 5 can penetrate deep into these depressions. Since the angle f between the centerline of the spike 5 and the outer wall of the balloon 1 is 45°-55°, and the tip of the spike 5 is positioned towards the cervix, the spike 5 can prevent the balloon 1 from dislodging when it attempts to dislodge, thus achieving the purpose of fixing the balloon 1.

[0040] The cross-sectional area of ​​the spike 5 gradually decreases from the outer wall of the balloon 1 outwards. The cross-section here is such that the connection between the spike 5 and the outer wall of the balloon 1 has a tangential surface, and the cross-section is parallel to the tangential surface. Preferably, the spike 5 is triangular pyramidal, and the tip of the spike 5 is arc-shaped.

[0041] The rounded tip prevents the 5th protrusion from penetrating deep into the recesses of the uterine cavity wall, thus avoiding discomfort. Figure 2 As shown, the radius R of the tip arc of the spike 5 is preferably 2-5 mm.

[0042] The height of the spike 5 is 10-20mm. If the spike 5 is too high, it will affect the contact between the balloon 1 and the uterine cavity wall, thus affecting the hemostatic effect; if the spike 5 is too low, it will affect the fixation effect of the spike 5. Therefore, the height of the spike 5 is limited to 10-20mm, so that the spike 5 can fix the balloon 1 while the balloon 1 can also have a good hemostatic effect.

[0043] The spikes 5 are distributed on the side and lower surfaces of the balloon 1. Figure 1 As shown, Figure 1 The diagram only shows the distribution of spikes in a single plane; in reality, spikes 5 are distributed in a ring on the circumference of the balloon 1.

[0044] The materials used for processing the spikes 5 and the balloon 1 can be the same or different. If the materials are the same, the wall thickness of the spikes 5 is preferably greater than that of the balloon 1 to increase the hardness of the spikes 5. If the materials are different, the hardness of the spikes 5 is preferably greater than that of the balloon 1, so that the hardness of the spikes 5 in the final product is greater than that of the balloon 1, which is beneficial for the fixation of the spikes 5.

[0045] The distance between adjacent spikes 5 gradually increases from the balloon side surface to the lower surface; and the ratio of the height of the spike 5 to its bottom diameter gradually decreases from the balloon side surface to the lower surface.

[0046] To achieve better hemostasis and reduce the number of spikes, thus lowering processing costs, the distribution density of spikes 5 varies gradually according to their position. The spikes on the side surface of balloon 1 are denser, facilitating better fixation. The spikes on the lower surface of balloon 1 are sparser, as the lower surface can provide some support through the pelvic floor muscles. Combined with the fixation effect of the spikes on the side surface, this helps to secure the entire balloon 1. Furthermore, the spikes on the lower surface of balloon 1 are distributed in a low and wide pattern, reducing the number of spikes and processing costs while improving hemostasis. This is because poor contraction of the lower uterine segment after childbirth commonly causes uterine bleeding; therefore, low and wide spikes increase anchoring force and compression area.

[0047] In addition, the ratio of the height to the bottom diameter of the spike 5 gradually changes with the position of the spike 5. The spike 5 located on the lower surface of the balloon 1 plays an auxiliary role in fixation. Therefore, the ratio of the height to the bottom diameter of the spike 5 decreases, thereby reducing the volume of the spike 5. Furthermore, the bottom diameter of the spike 5 gradually increases from the side surface of the balloon to the lower surface, but the total spike volume gradually decreases, making the lower spike short and wide. This further reduces processing costs, reduces processing difficulty, and improves hemostasis.

[0048] Specifically, the spacing between the spikes 5 in the uppermost row on the side surface of balloon 1 is A, and the spacing A is 18mm-30mm; extending from the side surface to the lower surface, A gradually increases in proportion a every two rows of spikes 5.

[0049] The proportion a is:

[0050]

[0051] In the above formula, d represents the center distance between the top row of spikes 5 on the side surface and the current spike 5, and the current spike 5 is the spike 5 whose spacing is to be adjusted; D is the center distance between the top row of spikes 5 on the side surface of balloon 1 and the bottom row of spikes 5 on the lower surface.

[0052] Among them, the distance L from the connection point between the center line of the uppermost row of spikes 5 on the side surface of balloon 1 and the top of balloon 1 is 0.25-0.3 times the distance L0 between the top and bottom of balloon 1. All these distances are along the arc of the surface of balloon 1.

[0053] The spikes in adjacent rows are staggered. Ultimately, the spikes exhibit a quincunx pattern.

[0054] The angle between the centerline of the spikes 5 and the outer wall of the balloon 1 gradually increases from the side surface to the bottom surface of the outer wall of the balloon 1. Specifically, the angle between the centerline of the uppermost row of spikes 5 on the side surface of the balloon 1 and the outer wall of the balloon 1 is 45°. Extending from the side surface to the bottom surface, the angle gradually increases with a ratio b every two rows of spikes 5, where the ratio b is 0.5°-1.5°.

[0055] Because the uterine cavity is shaped like a larger upper part and a smaller lower part, the angle between the center line of the spur 5 and the outer wall of the balloon 1 gradually changes with the position of the spur 5, thus ensuring that the spur 5 at each position can better penetrate into the depression of the inner wall of the uterine cavity and has a better fixation effect.

[0056] The drainage port is 5-7mm long and 5-7mm wide. Blood from the uterine cavity is drained through the drainage port. The increased size of the drainage port reduces the risk of blockage in the drainage tube 3, ensuring smooth blood flow even with small amounts of blood clots. A blood collection bag can be connected to the drainage tube 3 to collect the drained blood. This bag allows for measurement of the bleeding volume, providing medical staff with data to facilitate timely intervention and prevent medical risks.

[0057] In addition, a valve 6 is provided on the connecting pipe 2, which can control the flow of saline solution and the injection rate.

[0058] When using the intrauterine anchoring spike balloon provided by this invention for hemostasis, physiological saline is injected into the balloon. Since both the balloon and the spike are made of soft material, the balloon and the spike expand, and the spike penetrates into the depression of the uterine wall to fix the balloon and prevent it from falling off. The balloon compresses the uterine wall to achieve the hemostatic effect.

[0059] When removing the balloon, the fluid inside the balloon is drawn out using a valve, both the balloon and the spike soften, and the spike is pulled out from the depression. Then the balloon can be removed directly without resistance, without causing damage to the uterine wall.

[0060] The above specific embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to examples, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A uterine cavity anchoring puncture balloon, comprising a balloon, a connecting tube, a drainage tube, and an outer casing, wherein the balloon is connected to the connecting tube, and the connecting tube is connected to an external water injection device; the drainage tube passes through the balloon and its end extends out of the balloon, and a drainage port is provided at the end of the drainage tube extending out of the balloon; the outer casing wraps around the connecting tube and the drainage tube; characterized in that, The outer wall of the balloon is provided with a number of spikes; when the balloon is inflated, the angle between the center line of the spikes and the outer wall of the balloon is 45°-55° and the tip of the spikes is facing the cervix. The spikes are distributed on the side and lower surfaces of the balloon; The spacing between adjacent spikes gradually increases from the side surface to the bottom surface; and the ratio of the height of the spike to its bottom diameter gradually decreases from the side surface to the bottom surface. The angle between the centerline of the spike and the outer wall of the balloon gradually increases from the side surface of the outer wall of the balloon towards the lower surface.

2. The intrauterine anchoring spur balloon according to claim 1, characterized in that, The spike is hollow inside, and its internal space is connected to the inside of the balloon.

3. The intrauterine anchoring spur balloon according to claim 1, characterized in that, The cross-sectional area of ​​the spike gradually decreases from the outer wall of the balloon outwards.

4. The intrauterine anchoring spur balloon according to claim 3, characterized in that, The spikes are triangular pyramidal in shape, and the tips of the spikes are arc-shaped.

5. The intrauterine anchoring spur balloon according to claim 4, characterized in that, The radius R of the tip arc of the spike is 2-5 mm.

6. The intrauterine anchoring spur balloon according to claim 4, characterized in that, The height of the spike is 10-20 mm.

7. The intrauterine anchoring spur balloon according to claim 1, characterized in that, The spacing between the spikes in the uppermost row on the lateral surface of the balloon is A, which is 18mm-30mm. Extending from the lateral surface to the lower surface, A gradually increases in proportion a every two rows of spikes. The proportion a is: In the above formula, d represents the center distance between the top row of spikes on the side surface and the current spike, where the current spike is the spike whose spacing is to be adjusted; D is the center distance between the top row of spikes on the side surface of the balloon and the bottom row of spikes on the lower surface.

8. The intrauterine anchoring spur balloon according to claim 7, characterized in that, The spikes in adjacent rows are staggered.

9. The intrauterine anchoring spur balloon according to claim 8, characterized in that, The angle between the center line of the uppermost row of spikes on the lateral surface of the balloon and the outer wall of the balloon is 45°. Extending from the lateral surface to the lower surface, the angle gradually increases with a ratio b every two rows of spikes, where b is 0.5°-1.5°.

10. The intrauterine anchoring spur balloon according to claim 1, characterized in that, The length of the guide port is 5-7mm and the width is 5-7mm.

11. The intrauterine anchoring spur balloon according to claim 1, characterized in that, A valve is installed on the connecting pipe.

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