A uterine balloon device

Abstract

This invention discloses an intrauterine balloon device, relating to the field of medical device technology. The intrauterine balloon device includes: a balloon, a first tube, a connector, a second tube, and a needle. One end of the first tube is fixedly connected to the balloon, and the other end is fixedly connected to the connector. The other end of the connector is connected to the second tube. The needle can pass through the second tube and is detachably connected to the connector to inject liquid into the balloon via the needle, connector, and first tube. The portion of the second tube extending into the connector can expand radially to engage with the connector, or contract radially to disengage from the connector. After the intrauterine balloon device of this invention is filled with liquid, the needle and second tube can be withdrawn. The second tube does not need to be fixed to the leg through the vagina, avoiding contact between the balloon, first tube, and connector remaining in the body and the external environment, effectively reducing the risk of infection.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an intrauterine balloon device. Background Technology

[0002] Intrauterine adhesions are a common gynecological condition that seriously impairs fertility and is difficult to treat. It primarily results from partial or complete adhesions of the uterine lining after damage, severely impacting women's physiological and psychological health. Intrauterine adhesions often cause menstrual abnormalities, such as oligomenorrhea, and severe adhesions can lead to amenorrhea and infertility. The incidence of cervical adhesions remains high in my country and is increasing with the rise in intrauterine surgeries.

[0003] In current clinical practice, uterine balloon stents are generally used to prevent re-adhesion after cervical adhesion separation surgery. This method involves placing a balloon inside the uterus, injecting saline solution to inflate the balloon, and connecting the end of the inflation catheter to an inflation connector. After inflation, the balloon is fixed to the patient's leg. In this method, the inflated connector is exposed outside the vagina. Since the vagina is a naturally bacterial environment, the balloon and catheter, which traverse the entire uterine cavity and vagina, and even come into contact with the outside world, increase the risk of infection. This results in a relatively short retention time of the balloon in the uterus, usually not exceeding one week, thus affecting the expected anti-adhesion effect. Furthermore, the catheter being fixed outside the patient causes significant foreign body sensation, affecting the patient's daily life.

[0004] In conclusion, how to provide an intrauterine balloon device that can reduce the risk of infection is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide an intrauterine balloon device that, after filling the balloon with liquid, can release the locking between the second tube and the connector, remove the ejector pin and the second tube, leaving only the balloon, the first tube and the connector inside the body, so that the part of the intrauterine balloon device remaining inside the body does not need to be exposed to the outside, thus reducing the risk of infection.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A uterine balloon device includes: a balloon, a first tube, a connector, a second tube, and a push pin. One end of the first tube is fixedly connected to the balloon, and the other end is fixedly connected to the connector. The other end of the connector is connected to the second tube.

[0008] The ejector pin can pass through the second tube and be detachably connected to the connector to inject liquid into the balloon via the ejector pin, the connector, and the first tube;

[0009] The portion of the second tube extending into the connector can expand radially to engage with the connector, or contract radially to disengage from the connector.

[0010] Optionally, a one-way valve is provided between the connector and the balloon.

[0011] Optionally, one of the inner wall of the connector sleeved outside the second tube and the outer wall of the second tube extending into the connector is provided with a protrusion, and the other of the inner wall of the connector sleeved outside the second tube and the outer wall of the second tube extending into the connector is provided with a recess for engaging or disengaging with the protrusion.

[0012] Optionally, the portion of the second tube extending into the connector is an elastic element capable of radial elastic deformation;

[0013] When the ejector pin is inserted into the connector, the second tube inserted into the connector expands radially until the concave portion engages with the convex portion; when the ejector pin is withdrawn, the second tube inserted into the connector contracts radially until the concave portion disengages from the convex portion.

[0014] Optionally, the second tube is provided with a first through hole and a second through hole communicating with the first through hole. The first through hole is located near one end of the connector and within the portion of the second tube that extends into the connector. The inner diameter of the first through hole is smaller than the inner diameter of the second through hole, the inner diameter of the second through hole is larger than the outer diameter of the ejector pin, and the inner diameter of the first through hole is smaller than the outer diameter of the ejector pin.

[0015] Optionally, the protrusion is an annular protrusion disposed on the inner sidewall of the connector, and the recess is an annular groove disposed on the outer sidewall of the second tube.

[0016] Optionally, the radial dimension of the second tube extending into the connector gradually increases from the end extending into the connector outwards.

[0017] Optionally, the portion of the second tube that extends into the connector is made of a soft material, and a sleeve is fixedly fitted around the outer periphery of the second tube, the sleeve having a hardness greater than that of the second tube.

[0018] Optionally, a one-way valve is provided inside the connector.

[0019] Optionally, the one-way valve has a slotted cut at one end facing the second tube, and the pin can pass through the slotted cut and extend into the one-way valve.

[0020] Optionally, the length of the slit is greater than half the circumference of the ejector pin.

[0021] Optionally, the first tube is a quincunx tube, and the quincunx tube is connected to the balloon;

[0022] And / or, the balloon, once filled with liquid, takes the shape of a heart to match the shape of the uterine cavity.

[0023] In using the intrauterine balloon device provided by this invention, firstly, the balloon, first tube, connector, second tube, ejector pin, and sheath need to be assembled externally, and the sheath is introduced into the vagina. Observation is performed using a hysteroscope, and the sheath is controlled to move to a preset position. The second tube is moved forward, pushing the connector and first tube forward until the balloon extends out of the sheath. Once the balloon is fully extended from the sheath, the first tube is controlled to move forward to a preset position; this process can be achieved by controlling the second tube to move forward relative to the sheath. The connector at the outer end of the ejector pin is connected to a syringe, and liquid is injected into the balloon sequentially through the ejector pin, one-way valve, and first tube. After the balloon is filled with liquid, the ejector pin is withdrawn, and the radial dimension of the second tube inserted into the connector shrinks, releasing the jamming between the second tube and the connector. The sheath and second tube are removed, leaving only the balloon, first tube, and connector inside the body.

[0024] Compared to existing technologies, the intrauterine balloon device of this invention allows for the retraction of the ejector pin, second tube, and sheath after the balloon is filled with liquid. This eliminates the need for the second tube to pass through the vagina and be fixed to the leg, thus preventing the balloon, first tube, and connectors remaining in the body from coming into contact with the external environment. This effectively reduces the risk of infection and extends the time the balloon remains in the body. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0026] Figure 1 for Figure 1 This is a schematic diagram of the external appearance of the intrauterine balloon device provided by the present invention;

[0027] Figure 2 for Figure 1 Cross-sectional schematic diagram of the intrauterine balloon device;

[0028] Figure 3 for Figure 1 Schematic diagram of the explosion of the intrauterine balloon device;

[0029] Figure 4 for Figure 3 Cross-sectional schematic diagram of the intrauterine balloon device;

[0030] Figure 5 This is a schematic diagram illustrating the process of the connector mating with the second pipe.

[0031] Figure 6 for Figure 5 Enlarged view of a portion of the central structure;

[0032] Figure 7 This is a schematic diagram showing the connector and the second pipe engaged and snapped together.

[0033] Figure 8 This is an isometric view of a check valve.

[0034] Figure 9 This is a cross-sectional schematic diagram of a check valve;

[0035] Figure 10 This is an isometric view of the first tube.

[0036] Figure 1-10 middle:

[0037] 1 is the balloon, 2 is the first tube, 21 is the injection hole, 3 is the sheath, 4 is the one-way valve, 41 is the straight incision, 5 is the connector, 51 is the protrusion, 6 is the second tube, 61 is the concave part, 62 is the first through hole, 63 is the second through hole, 7 is the kit, and 8 is the ejector pin. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] The core of this invention is to provide an intrauterine balloon device that, after filling the balloon with liquid, can release the locking between the second tube and the connector, allowing the needle and the second tube to be removed, leaving only the balloon, the first tube, and the connector inside the body. This ensures that the part of the intrauterine balloon device remaining inside the body does not need external contact, reducing the risk of infection.

[0040] Please refer to Figure 1-10 .

[0041] This specific embodiment discloses a uterine balloon device, including: a balloon 1, a first tube 2, a connector 5, a second tube 6, and a pusher 8. One end of the first tube 2 is fixedly connected to the balloon 1, and the other end is fixedly connected to the connector 5. The other end of the connector 5 is connected to the second tube 6. The pusher can pass through the second tube 6 and be detachably connected to the connector 5 to inject liquid into the balloon 1 through the pusher 8, the connector 5, and the first tube 2. The portion of the second tube 6 that extends into the connector 5 can expand radially to engage with the connector 5, or contract radially to disengage from the connector 5.

[0042] It should be noted that the outer end of the ejector pin 8 can be connected to an injection device such as a syringe. As one implementation, a Luer connector is provided at the outer end of the ejector pin 8, and the ejector pin is connected to an injection device such as a syringe through the Luer connector.

[0043] It should be noted that the radial expansion and contraction of the second tube 6 extending into the connector 5 can be achieved by supporting or releasing the second tube 6 with the ejector pin 8, or by setting a retractable bracket along the radial direction of the second tube 6 inside the second tube 6, and controlling the extension and retraction of the bracket to control the radial expansion and contraction of the second tube 6 extending into the connector 5; of course, the connector 5 and the second tube 6 can also be engaged in other snap-fit ​​methods, which will not be elaborated here.

[0044] The ejector pin 8 is a rigid tube, preferably a metal tube. The end of the ejector pin 8 is designed to facilitate the insertion of the connector 5, and the radius of the end gradually decreases in the axial outward direction.

[0045] Compared to existing technologies, in this specific embodiment, after the intrauterine balloon device is filled with liquid, the ejector pin 8, the second tube 6, and the sheath 3 can be withdrawn. The second tube 6 does not need to pass through the vagina and be fixed to the leg, thus avoiding contact between the balloon 1, the first tube 2, the one-way valve 4, and the connector 5 remaining in the body and the external environment. This can effectively reduce the risk of infection and prolong the time the balloon 1 remains in the body.

[0046] In one specific embodiment, one of the inner sidewall of the connector 5 sleeved outside the second tube 6 and the outer sidewall of the second tube 6 extending into the connector 5 is provided with a protrusion 51, and the other of the inner sidewall of the connector 5 sleeved outside the second tube 6 and the outer sidewall of the second tube 6 extending into the connector 5 is provided with a recess 61 for engaging or disengaging with the protrusion 51.

[0047] Specifically, the second tube 6 extending into the connector 5 can be configured as an elastic element that can deform elastically in the radial direction; when the ejector pin 8 is connected to the one-way valve 4, the second tube 6 extending into the connector 5 expands radially until the concave part 61 engages with the convex part 51; when the ejector pin 8 is pulled out, the second tube 6 extending into the connector 5 contracts radially until the concave part 61 disengages from the convex part 51.

[0048] like Figure 5 As shown, the second tube 6 has a first through hole 62 and a second through hole 63 communicating with the first through hole 62. The first through hole 62 is located near the end of the connector 5, and the inner diameter of the first through hole 62 is smaller than the inner diameter of the second through hole 63. The inner diameter of the second through hole 63 is larger than the outer diameter of the ejector pin 8, and the inner diameter of the first through hole 62 is smaller than the outer diameter of the ejector pin 8. The part of the second tube 6 that extends into the connector 5 can be called the connecting part, and the part of the second tube 6 that connects to the connecting part can be called the straight tube part. The first through hole 62 is located within at least a portion of the length of the connecting part of the second tube 6. It can be understood that the length of the first through hole 62 can be the same as the length of the connecting part that extends into the connector 5, or it can be longer or shorter, as long as the portion of the first through hole 62 in the connecting part of the second tube 6 can expand radially to ensure engagement with the connector 5, and contract radially to ensure release from engagement with the connector 5. Preferably, the length of the first through hole 62 is substantially the same as the length of the portion that extends into the connector 5. The second through hole 63 is located in the straight section of the second tube 6. Preferably, the straight section and the connecting section are integrally formed and made of the same material.

[0049] During operation, the ejector pin 8 passes sequentially through the second through hole 63 and the first through hole 62 inside the second tube 6. Since the inner diameter of the second through hole 63 is larger than the outer diameter of the ejector pin 8, the ejector pin 8 can pass smoothly through it. Because the inner diameter of the first through hole 62 is smaller than the outer diameter of the ejector pin 8, the radial dimension of the first through hole 62 increases as the ejector pin 8 passes through it. This, in turn, increases the radial dimension of the second tube 6 extending into the connector 5, allowing the protrusion 51 and the recess 61 to engage and lock together. Specifically, as follows... Figure 7 As shown; after the ejector pin 8 is pulled out, the ejector pin 8 comes out through the first through hole 62. Since the second tube 6 extending into the connector 5 is an elastic element, under the action of elastic force, the radial dimension of the second tube 6 extending into the connector 5 shrinks, so that the protrusion 51 and the concave part 61 are released from the engagement.

[0050] Preferably, the protrusion 51 can be configured as an annular protrusion located on the inner sidewall of the connector 5, and the recess 61 can be configured as an annular groove located on the outer sidewall of the second tube 6. Specifically, the cross-section of the annular protrusion can be configured as approximately semi-circular, so that the annular groove and the annular protrusion can be easily matched while preventing slippage.

[0051] To facilitate the insertion of the second tube 6 into the connector 5, the connector 5 can be configured as a tapered structure, and the radial dimension of the second tube 6 inserted into the connector 5 gradually increases from the end inserted into the connector 5 to the outer end of the second tube 6.

[0052] In one specific embodiment, the connecting part of the second tube 6 is made of a soft material, and the straight part of the second tube 6 can be made of either a soft or a hard material. As a preferred embodiment, the straight part of the second tube 6 is also made of a soft material. Soft materials include silicone, latex, polyurethane, etc., with silicone being the preferred material. When the straight part of the second tube 6 is also made of a soft material, to facilitate the insertion of the second tube 6 into the connector 5, a sleeve 7 can be fixedly fitted around the outer periphery of the second tube 6. The sleeve 7 can be a tube, and its hardness is greater than that of the second tube 6 to provide support when the second tube 6 is pushed forward. Generally, the sleeve 7 can be made of plastic, and its inner wall is tightly fitted against the outer wall of the second tube 6 to facilitate axial movement of the second tube 6. Simultaneously, when the ejector pin 8 is pushed in, the sleeve 7 can be gripped to allow the ejector pin 8 to insert the one-way valve 4 into the second tube 6.

[0053] A one-way valve 4 is fixedly provided between the connector 5 and the balloon 1. For example, the one-way valve 4 can be installed in the first tube 2 or the connector 5. As a preferred embodiment, the one-way valve 4 is installed in the connector 5. The one-way valve 4 can prevent liquid from flowing back from the balloon 1 out of the ejector pin 8. The one-way valve 4 and the connector 5 can be configured as an integral structure or as a separate structure. For ease of processing, they are configured separately. Figure 9 As shown, the end of the one-way valve 4 facing the second tube 6 has a slotted slit 41. The ejector pin 8 can pass through the slotted slit 41 and extend into the one-way valve 4. After the ejector pin 8 passes through the slotted slit 41 and enters the one-way valve 4, the ejector pin 8, the one-way valve 4, the first tube 2, and the balloon 1 can be connected, allowing liquid to be injected into the balloon 1 through the ejector pin 8. When the ejector pin 8 is removed from the one-way valve 4, the slotted slit 41 automatically closes under the action of elastic force, preventing the liquid in the balloon 1 from flowing out. Preferably, the length of the slotted slit is greater than half the circumference of the ejector pin.

[0054] Preferably, the material of the connector 5 is the same as that of the one-way valve 4 and the second tube 6, namely silicone, latex, or polyurethane. Using the same material makes connection easier, and silicone is less likely to cause injury to internal parts. The ejector pin 8 is a rigid tube, preferably a metal tube; the end of the ejector pin 8 gradually tapers outwards along the axial direction to facilitate insertion into the one-way valve 4.

[0055] In one embodiment of the intrauterine balloon device provided in this application, firstly, the balloon 1, first tube 2, connector 5, second tube 6, ejector pin 8, and sheath 3 are assembled externally, and the sheath 3 is introduced into the vagina. Using a hysteroscope, the sheath 3 is moved to a preset position. The second tube 6 is moved forward, pushing the connector 5 and first tube 2 forward until the balloon 1 extends out of the sheath 3. Once the balloon 1 is fully extended from the sheath 3, the first tube 2 and balloon 1 are moved forward to a preset position. This process can be achieved by controlling the second tube 6 to move forward relative to the sheath 3. The connector at the outer end of the ejector pin 8 is connected to a syringe. Liquid is injected into the balloon 1 sequentially through the ejector pin 8, one-way valve 4, and first tube 2. After the balloon 1 is filled with liquid, the ejector pin 8 is withdrawn, and the radial dimension of the portion of the second tube 6 inserted into the connector 5 shrinks, releasing the jamming between the second tube 6 and the connector 5. The sheath 3 and second tube 6 are removed, leaving only the balloon 1, first tube 2, one-way valve 4, and connector 5 inside the body. When removing balloon 1 from the uterine cavity, the second tube 6 and the kit 7 are pre-fitted, with the portion of the second tube 6 ready to be inserted into the connector 5 exposed (the ejector pin 8 can be pre-inserted into the second through hole 63 of the second tube 6); the fitted second tube 6 and kit 7 are introduced into the vagina 3, and the second tube 6 is moved forward to the position of the connector 5, with the exposed portion of the second tube 6 inserted into the connector 5. The ejector pin 8 is then inserted or pushed, allowing it to pass through the first through hole 61 and the one-way valve 4 in sequence. When passing through the first through hole 61, the portion of the second tube 6 inserted into the connector 5 expands radially, causing the two to engage. When the ejector pin 8 is inserted into the one-way valve 4, the one-way valve 4 needs to be opened by the insertion of the ejector pin 8. To prevent balloon 1 from moving forward under the force of insertion, the positions of the kit 7 and the second tube 6 can be fixed when the ejector pin 8 is inserted into the one-way valve 4. Afterwards, balloon 1 and the first tube 2 are connected through the ejector pin 8, and after the fluid in balloon 1 is extracted, the second tube 6, balloon 1, first tube 2, one-way valve 4, and connector 5 are removed.

[0056] Preferably, the first tube 2 can be configured as a plum blossom tube, which is connected to the balloon 1. Compared to a cylindrical tube, the plum blossom tube provides greater radial support for cervical dilation. If the outer diameter of the cylindrical tube is large, intrauterine bleeding and inflammatory exudate will have difficulty flowing out and will accumulate in the uterine cavity; if the outer diameter of the cylindrical tube is small, the radial support is insufficient, the cervix cannot be dilated, and the tube segment cannot be pushed to the designated position. Compared to a cylindrical tube with a smaller outer diameter, the protruding part of the plum blossom tube can achieve greater support. In addition, the gaps between the protrusions in the plum blossom tube can achieve a drainage effect, allowing intrauterine bleeding and inflammatory exudate to flow out along the gaps and be discharged from the vagina, reducing the risk of infection and better preventing the formation of re-adhesions. Specifically, such as... Figure 10 As shown, three injection holes 21 can be set at one end of the plum blossom tube, and the liquid enters the balloon 1 through the injection holes 21.

[0057] Furthermore, the balloon 1 can be made into a heart shape after being filled with liquid, matching the shape of the uterine cavity and thus effectively filling and blocking the uterine cavity.

[0058] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. Any combination of all embodiments provided by this invention is within the scope of protection of this invention and will not be elaborated upon here.

[0059] The intrauterine balloon device provided by this invention has been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the embodiments above are merely for the purpose of helping to understand the method and core ideas of this invention. It should be noted that those skilled in the art can make various improvements and modifications to this invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of this invention.

Claims

1. A uterine balloon device, characterized in that, include: The balloon (1), the first tube (2), the connector (5), the second tube (6) and the ejector pin (8) are provided. One end of the first tube (2) is fixedly connected to the balloon (1), and the other end is fixedly connected to the connector (5). The other end of the connector (5) is connected to the second tube (6). The ejector pin (8) can be detachably connected to the connector (5) through the second tube (6) to inject liquid into the balloon (1) via the ejector pin (8), the connector (5), and the first tube (2); The portion of the second tube (6) that extends into the connector (5) can expand radially to engage with the connector (5), or contract radially to disengage from the connector (5); One of the inner wall of the connector (5) sleeved outside the second tube (6) and the outer wall of the second tube (6) extending into the connector (5) is provided with a protrusion (51), and the other of the inner wall of the connector (5) sleeved outside the second tube (6) and the outer wall of the second tube (6) extending into the connector (5) is provided with a recess (61) for engaging or disengaging with the protrusion (51). The portion of the second tube (6) that extends into the connector (5) is an elastic element capable of elastic deformation in the radial direction; When the ejector pin (8) is inserted into the connector (5), the second tube (6) inserted into the connector (5) expands radially to engage with the recess (61) and the protrusion (51); when the ejector pin (8) is pulled out, the second tube (6) inserted into the connector (5) contracts radially to disengage from the recess (61) and the protrusion (51).

2. The intrauterine balloon device according to claim 1, characterized in that, A one-way valve (4) is provided between the connector (5) and the balloon (1).

3. The intrauterine balloon device according to claim 1, characterized in that, The second tube (6) is provided with a first through hole (62) and a second through hole (63) communicating with the first through hole (62). The first through hole (62) is located at one end near the connector (5) and within the part of the second tube (6) that extends into the connector (5). The inner diameter of the first through hole (62) is smaller than the inner diameter of the second through hole (63), the inner diameter of the second through hole (63) is larger than the outer diameter of the ejector pin (8), and the inner diameter of the first through hole (62) is smaller than the outer diameter of the ejector pin (8).

4. The intrauterine balloon device according to claim 1, characterized in that, The protrusion (51) is an annular protrusion provided on the inner sidewall of the connector (5), and the recess (61) is an annular groove provided on the outer sidewall of the second tube (6).

5. The intrauterine balloon device according to claim 1, characterized in that, The radial dimension of the second tube (6) extending into the connector (5) gradually increases from the end extending into the connector (5) outward.

6. The intrauterine balloon device according to claim 1, characterized in that, The portion of the second tube (6) that extends into the connector (5) is made of soft material. A sleeve (7) is fixedly fitted around the outer periphery of the second tube (6). The hardness of the sleeve (7) is greater than that of the second tube (6).

7. The intrauterine balloon device according to any one of claims 1-6, characterized in that, A one-way valve (4) is provided inside the connector (5).

8. The intrauterine balloon device according to claim 7, characterized in that, The one-way valve (4) has a slot (41) facing the second tube (6) at one end, and the pin (8) can pass through the slot (41) and extend into the one-way valve (4).

9. The intrauterine balloon device according to claim 8, characterized in that, The length of the incision (41) is greater than half the circumference of the pin (8).

10. The intrauterine balloon device according to any one of claims 1-6, characterized in that, The first tube (2) is a plum blossom tube, and the plum blossom tube is connected to the balloon (1); And / or, the balloon (1) is filled with liquid and is heart-shaped to match the shape of the uterine cavity.

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