Uterine cavity anchoring spike balloon

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a uterine cavity anchoring spike balloon which comprises a balloon body, a connecting pipe, a flow guide pipe and an outer wrapping pipe, the balloon body is communicated with the connecting pipe, and the connecting pipe is communicated with an external water injection device; the flow guide tube penetrates through the balloon, the end of the flow guide tube extends out of the balloon, and a flow guide opening is formed in the end, extending out of the balloon, of the flow guide tube. The outer wrapping pipe wraps the connecting pipe and the flow guide pipe; the balloon is characterized in that a plurality of spikes are arranged on the outer wall of the balloon; after the balloon expands, the included angle between the center line of the spikes and the outer wall of the balloon ranges from 45 degrees to 55 degrees, and the top ends of the spikes are arranged towards the cervix. The balloon can be prevented from slipping off, and the infection risk caused by repeated implantation is avoided. Meanwhile, the flow guide pipe is prevented from being blocked.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to an intrauterine anchoring spike balloon. Background Art

[0002] Postpartum hemorrhage is a serious complication during the delivery period, mainly occurring in three periods: from the delivery of the fetus to the delivery of the placenta, from the delivery of the placenta to 2 hours after childbirth, and from 2 hours after childbirth to 24 hours after childbirth. Since the bleeding point is located within the uterine cavity, this type of bleeding is characterized by rapid bleeding, large bleeding volume, diffuse bleeding points, difficult exposure, and inability to stop bleeding under direct vision. Therefore, tools are needed for rapid hemostasis. Balloon packing is one of the effective methods for hemostasis after childbirth (postoperative), and is currently widely used in clinical practice. After the balloon is packed into the uterine cavity, 200 - 500 ml of liquid can be filled to achieve the purpose of compressing the uterine cavity to stop bleeding.

[0003] The existing intrauterine balloons mainly consist of a guiding tube and a balloon. The balloon passes through the guiding tube, and the guiding tube is used for draining the blood in the uterine cavity. The surface of the balloon is a smooth spherical surface, and with the lubrication of blood and residual amniotic fluid, the following problems are likely to occur:

[0004] 1. After being placed in the corresponding position and filled with water, due to the smooth surface of the balloon and its easy deformation, it will fall off naturally, requiring repeated re - placement, delaying hemostasis, and being prone to infection;

[0005] 2. After the balloon is placed and filled with water, it is easy to fall off to the lower uterine segment and cannot compress the uterine cavity;

[0006] 3. In order to prevent the balloon from prolapsing, vaginal packing with gauze is often used, which is prone to being forgotten to be removed, resulting in a possible secondary infection. Moreover, the gauze fixation cannot be fixed in the effective position, only preventing it from prolapsing from the vagina.

[0007] 4. The opening at the top of the balloon is small, and it is easy to be blocked after small blood clots are formed due to uterine cavity bleeding.

[0008] The prior art CN109805975B discloses a uterine cavity balloon device for real-time pressure measurement and control, which 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 outer peripheries of the first inflation tube, the second inflation tube and the liquid outlet tube, the air outlet of the first inflation tube is in fluid communication with the first inflatable balloon, the air outlet of the second inflation tube is in fluid communication with the second inflatable balloon, and the front end of the outer tube sequentially passes through the second inflatable balloon and the first inflatable balloon; the two pressure gauges are respectively communicated with the inflation ports at the rear ends of the first inflation tube and the second inflation tube. This uterine cavity balloon device places the second inflatable balloon at the cervix to prevent the first inflatable balloon from prolapsing. However, since the surface of the second inflatable balloon is also a smooth surface, the fixing effect is limited, and it cannot completely prevent the movement of the first inflatable balloon, and thus may not be able to stop bleeding in time. Summary of the Invention

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

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

[0011] A uterine cavity anchored spike balloon includes a balloon, a connecting tube, a diversion tube and an outer tube. The balloon is in communication with the connecting tube, and the connecting tube is in communication with an external water injection device; the diversion tube penetrates through the balloon and the end of the diversion tube extends out of the balloon, and a diversion port is provided at the end of the diversion tube extending out of the balloon; the outer tube wraps around the outside of the connecting tube and the diversion tube; a plurality of spikes are provided on the outer wall of the balloon; when the balloon expands, the included angle between the center line of the spike and the outer wall of the balloon is 45° - 55°, and the top of the spike is arranged towards the cervical orifice.

[0012] Further, the spike is hollow inside, and the internal space is in communication with the inside of the balloon.

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

[0014] Furthermore, the spike is triangular pyramid-shaped, and the tip of the spike is arc-shaped.

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

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

[0017] Further, the spikes are distributed on the side surface and the lower surface of the balloon.

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

[0019] Furthermore, the spacing of the spikes in the uppermost row on the side surface of the balloon is A, and the spacing A is 18 mm - 30 mm; in the direction from the side surface to the bottom surface, for every two rows of spikes spaced apart, A gradually increases in proportion a;

[0020] The proportion a is:

[0021]

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

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

[0024] Furthermore, the angle between the center line of the spikes and the outer wall of the balloon gradually increases in the direction from the side surface to the bottom surface of the outer wall of the balloon.

[0025] Furthermore, the angle between the center line of the spikes in the uppermost row on the side surface of the balloon and the outer wall of the balloon is 45°, and in the direction from the side surface to the bottom surface, for every two rows of spikes spaced apart, the angle gradually increases in proportion b, and the proportion b is 0.5° - 1.5°.

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

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

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

[0029] The uterine cavity anchoring spike balloon provided by the present invention is provided with a plurality of spikes on the outer wall of the balloon. The spikes can expand with the balloon, and the angle between the spikes and the outer wall of the balloon is 45° - 55° and the tips of the spikes are arranged towards the cervical orifice. Therefore, when the uterine cavity anchoring spike balloon is placed in the postpartum uterine cavity, after the spikes expand, they can penetrate into the recesses of the uterine cavity, and then be anchored on the uneven surface of the uterine cavity, making the balloon not easy to fall off. And it can also press the balloon to the recessed part of the uterine cavity, thereby making the compression more sufficient and improving the hemostasis effect. After the balloon is fixed, there is no need to re - insert it multiple times, reducing the risk of infection, and there is no need to pack gauze in the vagina, further reducing the risk of infection. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0032] Explanation of the reference numerals in the drawings:

[0033] 1 - balloon, 2 - connecting tube, 3 - diversion tube, 4 - outer sheath, 5 - spike, 6 - valve. Specific implementation manners

[0034] The technical solution of the present invention will be clearly described below in conjunction with the drawings. Obviously, the described embodiments are not all embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

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

[0036] The following description of the exemplary embodiments is merely illustrative and in no sense limits the present invention or its application or use. Technologies, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail here, but when applicable, these technologies, methods, and devices should be regarded as part of this specification.

[0037] The present invention provides an intrauterine anchoring spike balloon, as Figure 1 and Figure 2 shown, including a balloon 1, a connecting tube 2, a diversion tube 3, and an outer sheath 4. The balloon 1 is in communication with the connecting tube 2, and the connecting tube 2 is in communication with an external water injection device; the diversion tube 3 passes through the balloon 1 and the end of the diversion tube 3 extends out of the balloon 1. The end of the diversion tube 3 extending out of the balloon 1 ( Figure 1 the upper end in ) is provided with a diversion port; the outer sheath 4 is wrapped outside the connecting tube 2 and the diversion tube 3; a plurality of spikes 5 are provided on the outer wall of the balloon 1; when the balloon 1 expands, the central line of the spike 5 forms an angle f of 45° - 55° with the outer wall of the balloon 1 and the top of the spike 5 is arranged towards the cervical orifice.

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

[0039] When using the intrauterine cavity anchoring spike balloon provided by the present invention, the balloon 1 is placed into the uterine cavity, and then normal saline is injected into the balloon 1 to make the balloon 1 expand. The inside of the spike 5 is communicated with the balloon 1, and the inside of the spike 5 is also filled with normal saline, so that the spike 5 bulges following the expansion of the balloon 1. Since the inner wall of the uterine cavity after childbirth is uneven with many depressions, the bulged spike 5 can penetrate into the depressions of the uterine cavity. Since the included angle f between the center line of the spike 5 and the outer wall of the balloon 1 is 45°-55° and the top of the spike 5 is arranged towards the cervical orifice. Therefore, when the balloon 1 is about to prolapse, the spike 5 can prevent the prolapse of the balloon 1, thereby 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. Here, the cross-section is: the connection between the spike 5 and the outer wall of the balloon 1 has a tangent surface, and the cross-section parallel to the tangent surface. Preferably, the spike 5 is triangular pyramid-shaped, and the tip of the spike 5 is arc-shaped.

[0041] The arc-shaped tip makes it so that when the spike 5 penetrates into the depression of the inner wall of the uterine cavity, it does not cause discomfort. As Figure 2 shown, the arc radius R of the tip of the spike 5 is preferably 2-5 mm.

[0042] The height of the spike 5 is 10-20 mm. If the spike 5 is too high, it will affect the contact between the balloon 1 and the inner wall of the uterine cavity and affect the hemostatic effect; if the spike 5 is too low, it will affect the fixing effect of the spike 5. Therefore, the height of the spike 5 is limited to 10-20 mm, 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 surface and the lower surface of the balloon 1. As Figure 1 shown, Figure 1 only the distribution of the spikes in one plane is shown. Actually, the spikes 5 are annularly distributed on the circumferential surface of the balloon 1.

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

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

[0046] For better hemostasis, and to reduce the number of spikes and processing costs, the distribution density of the spikes 5 gradually changes according to the position of the spikes 5. The spikes on the side surface of the balloon 1 are more densely distributed, which is beneficial for better fixing the balloon 1. The spikes 5 on the lower surface of the balloon 1 are less densely distributed because the lower surface of the balloon 1 can provide part of the support through the pelvic floor muscles. Combining with the fixing effect of the spikes on the side surface of the balloon 1, it can play a role in fixing the entire balloon 1. Furthermore, the spikes 5 on the lower surface of the balloon 1 are distributed in a low and wide shape, which can reduce the number of spikes 5, reduce processing costs, and improve the hemostasis effect at the same time. This is because the lower segment of the uterus contracts poorly after childbirth, resulting in common uterine bleeding after childbirth. Therefore, the low and wide spikes are beneficial for increasing the anchoring force and compression area.

[0047] In addition, the ratio of the height to the bottom diameter of the spikes 5 also gradually changes according to the position of the spikes 5. The fixing effect of the spikes 5 on the lower surface of the balloon 1 is auxiliary. Therefore, the ratio of the height to the bottom diameter of the spikes 5 decreases, thereby reducing the volume of the spikes 5. In addition, the bottom diameter of the spikes 5 gradually increases in the direction from the side surface to the lower surface of the balloon, but the total volume of the spikes gradually decreases, making the lower spikes in a low and wide shape, further reducing processing costs and also reducing processing difficulty and improving the hemostasis effect.

[0048] Specifically, the spacing between the spikes 5 in the top row on the side surface of the balloon 1 is A, and the spacing A is 18 mm - 30 mm; in the direction from the side surface to the lower surface, every two rows of spikes 5 are spaced apart, and A gradually increases according to the ratio a.

[0049] The ratio a is:

[0050]

[0051] In the above formula, d represents the center distance between the spike 5 in the top row 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 spike 5 in the top row on the side surface of the balloon 1 and the spike 5 in the bottom row on the lower surface.

[0052] Among them, for the spike 5 in the top row on the side surface of the balloon 1, the connection point of the height center line of the spike 5 and the balloon 1, the distance L from the top of the balloon 1, is 0.25 - 0.3 times the distance L0 from the top to the bottom of the balloon 1. Here, all the distances are the arc distances along the surface of the balloon 1.

[0053] The adjacent rows of spikes 5 are staggered. Finally, the spikes 5 present a plum blossom distribution.

[0054] The angle between the center line of the spike 5 and the outer wall of the balloon 1 gradually increases from the side surface to the lower surface of the outer wall of the balloon 1. Specifically, the angle between the center line of the spike 5 in the top row on the side surface of the balloon 1 and the outer wall of the balloon 1 is 45°, and the angle between every two rows of spikes 5 increases according to a ratio b, and the ratio b is 0.5°-1.5°.

[0055] Since the uterine cavity is larger at the top and smaller at the bottom, the angle between the center line of the spike 5 and the outer wall of the balloon 1 gradually changes with the position of the spike 5, thereby ensuring that the spike 5 at each position can better penetrate into the depression of the inner wall of the uterine cavity and has a better fixing effect.

[0056] The length of the diversion port is 5-7mm and the width is 5-7mm. The blood in the uterine cavity is discharged from the body through the diversion port. When the diversion port size is increased, the blockage of the diversion tube 3 can be reduced. Even if there is a small amount of blood clots in the blood, it does not affect the discharge of blood. The diversion tube 3 can also be connected to a blood collection bag to collect the discharged blood. The blood collection bag can be used to measure the amount of bleeding. The amount of bleeding can provide corresponding data for medical staff, which is conducive to taking timely measures to avoid the occurrence of medical risks.

[0057] In addition, a valve 6 is provided on the connecting tube 2, and the on / off and injection speed of the physiological saline can be controlled by the valve 6.

[0058] When using the intrauterine anchoring spike balloon provided by the present invention for hemostasis, physiological saline is injected into the balloon. Since the balloon and the spike are both made of soft materials, the balloon and the spike expand, and the spike penetrates into the depression of the inner wall of the uterus to fix the balloon and prevent it from falling off. The balloon presses the inner wall of the uterus to achieve a hemostasis effect.

[0059] When removing the balloon, use the valve to extract the liquid inside the balloon, the balloon and the spikes become soft, the spikes are pulled out from the depression, and then the balloon can be removed directly without resistance without causing damage to the inner wall of the uterus.

[0060] The above specific implementation methods are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to examples, a person skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.

Claims

1. A uterine cavity anchoring spike balloon, comprising a balloon, a connecting tube, a drainage tube and an outer tube, wherein the balloon is connected to the connecting tube, and the connecting tube is connected to an external water injection device; the drainage tube is passed through the balloon and the end of the drainage tube extends out of the balloon, and a drainage port is arranged at the end of the drainage tube extending out of the balloon; the outer tube is wrapped around the outside of the connecting tube and the drainage tube; characterized in that A plurality of spikes are arranged on the outer wall of the balloon; when the balloon is expanded, the angle between the center line of the spike and the outer wall of the balloon is 45°-55° and the top of the spike is arranged toward the cervical opening.

2. The uterine cavity anchoring spike balloon according to claim 1, characterized in that: The interior of the spike is hollow, and the internal space is communicated with the interior of the balloon.

3. The uterine cavity anchoring spike balloon according to claim 1, characterized in that: The cross-sectional area of ​​the spikes gradually decreases from the outer wall of the balloon to the outside.

4. The uterine cavity anchoring spike balloon according to claim 3, characterized in that: The spike is in the shape of a triangular cone, and the tip of the spike is in the shape of an arc.

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

6. The uterine cavity anchoring spike balloon according to claim 4, characterized in that: The height of the spikes is 10-20 mm.

7. The uterine cavity anchoring spike balloon according to claim 1, characterized in that: The spikes are distributed on the side surface and the lower surface of the balloon.

8. The uterine cavity anchoring spike balloon according to claim 7, characterized in that: The distance between adjacent spikes increases gradually from the side surface to the lower surface; and the ratio of the height of the spikes to the bottom diameter decreases gradually from the side surface to the lower surface.

9. The uterine cavity anchoring spike balloon according to claim 8, characterized in that: The spacing of the top row of spikes on the side surface of the balloon is A, and the spacing A is 18mm-30mm; in the direction extending from the side surface to the lower surface, every two rows of spikes, A gradually increases according to the ratio a; The ratio 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, and 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.

10. The uterine cavity anchoring spike balloon according to claim 9, characterized in that: The spikes in adjacent rows are staggered.

11. The uterine cavity anchoring spike balloon according to claim 7, characterized in that: The angle between the center line of the spike and the outer wall of the balloon gradually increases from the side surface of the outer wall of the balloon to the lower surface.

12. The uterine cavity anchoring spike balloon according to claim 11, characterized in that: The angle between the center line of the top row of spikes on the side surface of the balloon and the outer wall of the balloon is 45°. Extending from the side surface to the lower surface, the angle gradually increases according to a ratio b for every two rows of spikes, and the ratio b is 0.5°-1.5°.

13. The uterine cavity anchoring spike balloon according to claim 1, characterized in that: The guide port has a length of 5-7 mm and a width of 5-7 mm.

14. The uterine cavity anchoring spike balloon according to claim 1, characterized in that: A valve is arranged on the connecting pipe.

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