Multi-valve uterine cavity anti-adhesion treatment device

Abstract

The invention provides a multi-valve uterine cavity anti-adhesion treatment device, and belongs to the technical field of uterine cavity postoperation continuous treatment instruments, the device comprises a treatment unit and a conveying unit, the treatment unit is provided with a supporting framework and a medicine carrying covering film, the supporting framework is composed of a plurality of valve-shaped components, each valve-shaped component is provided with a large end and a small end, and the large end and the small end are communicated through the medicine carrying covering film. The small ends of all the petal-shaped components are connected together, the supporting framework in the expanded state is of a big-end-up three-dimensional structure defined by the multiple petal-shaped components, any two adjacent petal-shaped components are movably matched, and the medicine carrying covering film is arranged on the supporting framework. Sustained-release medicine is arranged in the medicine-carrying covering film; the conveying unit is used for loading the treatment unit in the contracted state and conveying the treatment unit to a target position to complete release; the technical problems that in the prior art, the effective utilization rate of medicine is low, after implantation, the medicine cannot be fully unfolded to achieve large-area wound isolation, and self-adaptive deformation cannot be achieved along with changes of the form of the uterine cavity in the uterine cavity treatment means after the intrauterine adhesion separation operation are solved.

Description

Technical Field

[0001] This invention belongs to the technical field of postoperative treatment devices for uterine cavity, specifically relating to a multi-valve uterine cavity anti-adhesion treatment device. Background Technology

[0002] While various methods and approaches exist for preventing recurrence after intrauterine adhesion lysis, a unified treatment plan that can absolutely and completely prevent recurrence remains lacking in clinical practice. Current main treatment measures include drug therapy, intrauterine device (IUD) blocking, and balloon dilation.

[0003] Estrogen is commonly used in drug treatment. Postoperatively, sequential artificial cycles of estrogen and progesterone are often used for 2-3 months, or estrogen may be used alone. This approach is effective in preventing postoperative re-adhesion in patients with mild to moderate intrauterine adhesions and can improve menstrual recovery and reproductive prognosis. However, the systemic bioavailability of oral estradiol is low, typically only 2% to 10%. It undergoes initial metabolism in the gastrointestinal tract and liver, resulting in the breakdown of most of the drug. In addition, long-term use of estrogen may increase the risk of endometrial hyperplasia and endometrial cancer.

[0004] Regarding instrumental barriers, the intrauterine device (IUD) is a classic method. It isolates the wound within the uterine cavity, reducing uterine wall adhesion, and is typically left in place for 2-3 months. However, this method is less effective for patients with severe adhesions, and postoperative menstrual and reproductive outcomes are not significantly improved. The IUD's coverage area is limited, making it difficult to effectively separate the anterior and posterior uterine walls, and it may trigger excessive inflammatory responses. Common "O"-shaped IUDs are less effective at blocking the uterine horns and uterine vault, while "T"-shaped IUDs are insufficient for separating the central uterine cavity. Furthermore, IUDs have problems such as mismatch with the uterine cavity shape, inability to completely cover the wound, and a tendency to shift after implantation, affecting treatment outcomes.

[0005] Balloon dilation has also been used to prevent adhesions after uterine cavity surgery, but its shape does not match the pear-shaped or triangular structure of the uterine cavity, making it unable to fully cover the wound and resulting in an unsatisfactory barrier effect. Furthermore, the excessive pressure exerted on local tissues after balloon inflatation can easily lead to necrosis of the compressed tissue.

[0006] Another method uses silicone sheets as a barrier material, but their soft texture makes them prone to folding and difficult to unfold after implantation, especially in large cases. Silicone sheets typically have a limited area and cannot achieve full coverage of the uterine cavity; their two-dimensional thin structure makes it difficult to adhere to the anterior and posterior walls of the uterus, only partially preventing adhesions between the anterior and posterior walls, and offering weaker protection against fibrous adhesions between the walls on the same side.

[0007] In addition, existing physical barrier devices have a fixed shape and poor deformation ability. They cannot adapt to changes in the shape of the uterine cavity when uterine contractions occur, and are prone to displacement or even detachment, thereby reducing the anti-adhesion effect.

[0008] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0009] The purpose of this invention is to provide a multi-valve intrauterine anti-adhesion treatment device to solve the technical problems of low drug utilization rate, inability to fully expand after implantation to achieve large-area wound isolation, and inability to adapt to changes in the shape of the intrauterine cavity (such as during uterine contractions) in existing intrauterine adhesiolysis treatment methods.

[0010] To achieve the above objectives, the multi-valve intrauterine anti-adhesion treatment device of the present invention provides the following technical solution: A multi-valve intrauterine anti-adhesion treatment device includes a treatment unit and a delivery unit. The treatment unit has a supporting frame and a drug-loaded coating. The supporting frame is composed of multiple valve-shaped components. Each valve-shaped component has a large end and a small end of different sizes. The small ends of all valve-shaped components are connected together. The supporting frame has a compressed state and an expanded state. In the expanded state, the supporting frame is formed by multiple valve-shaped components enclosing a three-dimensional structure that is larger at the top and smaller at the bottom. Any two adjacent valve-shaped components can move and cooperate so that the volume of the supporting frame in the expanded state changes with the change of the intrauterine cavity. The drug-loaded membrane is arranged on the supporting skeleton; the drug-loaded membrane contains a sustained-release drug to promote the repair of the endometrium. The delivery unit is used to load the treatment unit in its contracted state and to deliver the treatment unit to the target location to complete the release.

[0011] As a further optimized technical solution, the petal-shaped component is a three-dimensional structure with an arc, which unfolds to both sides in the shape of an inverted raindrop.

[0012] As a further optimized technical solution, the supporting frame has symmetrically formed arc-shaped protruding ears on both sides opposite to the opening position at the distal end, so that the supporting frame can fully fit the uterine cavity.

[0013] As a further optimized technical solution, the proximal end of the support frame is provided with a flexible tail for withdrawing the treatment unit from the uterine cavity.

[0014] As a further optimized technical solution, the drug-loaded coating has at least one sustained-release layer, and at least one drug is uniformly distributed in each sustained-release layer.

[0015] As a further optimized technical solution, the drug-loaded coating on the outer side of all the aforementioned petal-shaped components is integrally formed.

[0016] As a further optimized technical solution, each of the petal-shaped components of the supporting skeleton is independently provided with a drug-loaded coating.

[0017] As a further optimized technical solution, the bottom of the support frame has a fixing seat, and each of the petal-shaped components is detachably connected to the fixing seat.

[0018] As a further optimized technical solution, the inner wall of the fixing base is provided with a slot, and the small end of the petal-shaped component is provided with a buckle that matches the slot. The assembly and fixing of the petal-shaped component are realized through the cooperation of the buckle and the slot.

[0019] As a further optimized technical solution, the delivery unit includes a delivery conduit, a push rod, and a positioning ring. The treatment unit is arranged in the lumen of the delivery conduit in a compressed state. The push rod is slidably disposed in the lumen of the delivery conduit for pushing the treatment unit. The positioning ring is slidably disposed on the outside of the delivery conduit for limiting the pushing depth of the delivery conduit.

[0020] Beneficial effects: First, the three-dimensional structure formed by the expansion of the support skeleton, which is larger at the top and smaller at the bottom, closely matches the pear-shaped physiological morphology of the human uterine cavity, allowing it to completely conform to the anterior, posterior, and lateral walls of the uterine cavity. Second, the movable and coordinated design of adjacent valve-like components allows the support skeleton to adaptively adjust its volume according to changes in the uterine cavity shape, such as uterine contractions, preventing instrument displacement and detachment, while also avoiding excessive pressure on the uterine tissue. Finally, the drug-loaded coating directly and locally releases the drug within the uterine cavity, avoiding the initial metabolism of orally administered drugs, improving drug utilization efficiency, and reducing the side effects of systemic medication.

[0021] Furthermore, the supporting frame, combined with the symmetrically designed arc-shaped protrusion at the distal end, can be precisely embedded in the depression of the uterine cavity and uterine horn, achieving full coverage of the uterine cavity wall (including the uterine horn) and solving the problem of incomplete coverage by existing instruments.

[0022] Furthermore, the flexible tail supporting the proximal end of the skeleton facilitates removal from the uterine cavity after treatment, and the entire operation does not require complex surgery, effectively reducing patient pain and surgical risks. Attached Figure Description

[0023] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein: Figure 1 This is a schematic diagram of the overall structure of the treatment unit in Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 2 This is a schematic diagram of the overall structure of the supporting skeleton of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 3 This is a schematic cross-sectional view of the treatment unit in Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 4This is a schematic diagram of the delivery unit structure of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 5 This is a schematic diagram of the pre-installed treatment unit structure within the delivery unit of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 6 This is an enlarged schematic diagram of the delivery unit structure of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 7 for Figure 5 A schematic diagram of the cross-section; Figure 8 This is a schematic diagram of the first release state of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention (at this time, the treatment unit is transported to a suitable position in the intrauterine cavity by the delivery unit). Figure 9 This is a schematic diagram of the second release state of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention (at this time, the treatment unit has just been pushed out of the delivery unit). Figure 10 This is a schematic diagram of the third release state of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention (at this time, the delivery unit is withdrawn and the treatment unit is fully expanded). Figure 11 This is a schematic diagram of the fourth release state of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention (at this time, part of the flexible tail is cut off). Figure 12 This is a schematic diagram of the fifth release state of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention (at this time, the final treatment state of the treatment unit is shown). Figure 13 This is a schematic diagram of the sixth release state of Embodiment 1 of the multi-valve intrauterine anti-adhesion treatment device of the present invention (at this time, the withdrawal state of the treatment unit is shown). Figure 14 This is a schematic diagram of the overall structure of the treatment unit in Embodiment 2 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 15 This is a schematic diagram of the overall structure of the treatment unit in Embodiment 3 of the multi-valve intrauterine anti-adhesion treatment device of the present invention; Figure 16 This is a schematic diagram of the overall structure of the treatment unit in Embodiment 4 of the multi-valve uterine cavity anti-adhesion treatment device of the present invention.

[0024] In the diagram: 100, treatment unit; 110, supporting frame; 111, flap-shaped component; 112, metal ring ligation bundle; 120, drug-loaded coating; 130, protruding ear; 140, flexible tail; 150, fixation base; 200, delivery unit; 210, delivery catheter; 220, push rod; 230, positioning ring; 240, handle; 250, fixation structure; 300, uterine cavity; 400, cutting tool; 500, clamping tool. Detailed Implementation

[0025] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0026] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances. Furthermore, the term "proximal end" uniformly refers to the end closer to the operator, while "distal end" refers to the end farther from the operator.

[0027] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0028] The shapes and sizes of the components in the accompanying drawings do not reflect the actual proportions of the product; they are only intended to illustrate the content of the invention.

[0029] This invention provides a multi-valve intrauterine anti-adhesion treatment device, mainly used to solve the problems of low drug utilization, incomplete wound coverage, and inability to adapt to changes in the uterine cavity 300 shape of existing treatment methods. The device includes a treatment unit 100 and a delivery unit 200. The treatment unit 100 includes a supporting frame 110 and a drug-loaded covering 120. The supporting frame 110 is composed of multi-valve, movable, flap-shaped components 111, which can switch between compressed and expanded states. After expansion, it forms a three-dimensional structure that conforms to the pear-shaped shape of the uterine cavity 300. A protruding ear 130 is provided at the distal end to cover the uterine horn, and a flexible tail 140 is provided at the proximal end for easy removal. The drug-loaded covering 120 carries a sustained-release drug and can be arranged integrally or independently to achieve precise local drug delivery. The delivery unit 200 includes a delivery catheter 210, a push rod 220, and a positioning ring 230, which can accurately deliver and release the treatment unit 100. This device can fully cover the uterine cavity 300 wound, adapt to uterine contraction deformation, improve drug utilization, is easy to operate, and effectively reduces the postoperative adhesion recurrence rate.

[0030] Example 1 like Figure 5 As shown, the intrauterine cavity 300 treatment device for preventing re-adhesion of the intrauterine cavity 300 includes a treatment unit 100 and a delivery unit 200. The treatment unit 100 is the core component for achieving intrauterine cavity 300 wound isolation and drug slow release, while the delivery unit 200 is responsible for safely and accurately delivering the treatment unit 100 to the target location of the intrauterine cavity 300 and completing the release.

[0031] Among them, such as Figure 1-3 As shown, the treatment unit 100 has a supporting frame 110 and a drug-loaded membrane 120. The supporting frame 110 serves as the structural basis of the treatment unit 100 and is composed of multiple petal-shaped components 111. Each petal-shaped component 111 has a large end and a small end of different sizes. The small ends of all the petal-shaped components 111 are fixedly connected together by a metal ring binding bundle 112. The supporting frame 110 is designed as a dual-form structure with a compressed state and an expanded state. In the compressed state, the radial dimension is smaller, which can be adapted to the lumen size of the delivery unit 200, facilitating delivery to the uterine cavity 300 via the cervix. In the expanded state, the supporting frame 110 is formed by multiple petal-shaped components 111 enclosing a three-dimensional funnel-shaped structure that is larger at the top and smaller at the bottom, with an elliptical cross-section. This structure is highly compatible with the pear-shaped physiological shape of the human uterine cavity 300, enabling complete coverage of the inner wall of the uterine cavity 300. Meanwhile, any two adjacent petal-shaped components 111 adopt a movable cooperation design, specifically: under the expansion of the petal-shaped components 111 themselves and the compression of the external uterine cavity 300, they can move closer or further away from each other, so that the overall volume of the support frame 110 can change with the shape of the uterine cavity 300 in the expanded state. For example, during uterine contraction, the volume of the uterine cavity 300 shrinks, and the compressed petal-shaped components 111 move closer to each other. After the contraction, the petal-shaped components 111 move further away from each other, thereby realizing the adaptive adjustment of volume, so that the volume of the support frame 110 automatically adapts to the change of the volume of the uterine cavity 300, avoiding displacement, dislodgement or excessive compression of the uterine cavity 300 tissue caused by the fixed shape of the instrument.

[0032] The drug-loaded membrane 120 is tightly arranged on the outer and / or inner walls of the supporting skeleton 110, and can directly contact the wound surface of the uterine cavity 300. It is uniformly loaded with sustained-release drugs (such as estradiol, progesterone, etc.). The drugs are slowly released into the local wound surface of the uterine cavity 300 through the drug-loaded membrane 120, and can directly act on the endometrium to promote endometrial repair and regeneration. At the same time, it avoids the first-pass metabolism problem of oral drugs, improves drug utilization efficiency, and reduces the side effects of systemic drug administration.

[0033] In this embodiment, the drug-loaded membrane 120 on all the petal-shaped components 111 is integrally formed. Specifically, firstly, all the petal-shaped components 111 are assembled into an integral support frame 110. Then, the integral drug-loaded membrane 120 is placed over the outer side of all the petal-shaped components 111 to form a complete membrane structure, ensuring the continuity of wound coverage, enhancing the structural synergy between the drug-loaded membrane 120 and the support frame 110, and adapting to the dynamic environment of the uterine cavity 300. In this way, the integral drug-loaded membrane 120 fits tightly with the outer wall of the petal-shaped components 111, without any stress weak points at the splicing points. When uterine contractions cause changes in the volume of the uterine cavity 300, the petal-shaped components 111 adjust their spacing through sliding cooperation, and the integral membrane can stretch or contract synchronously with the frame, preventing the wound from being exposed due to discontinuities at the splicing points of segmented membranes. In addition, the integrally formed drug-loaded membrane 120 does not require individual preparation, application, and assembly of each petal-shaped component 111, effectively improving production efficiency.

[0034] Furthermore, the drug-loaded coating 120 has at least one sustained-release layer, with at least one drug uniformly distributed within each sustained-release layer. In this embodiment, the drug-loaded coating 120 consists of 1-9 sustained-release layers, with each sustained-release layer containing 1-5 types of drugs. The drugs in each sustained-release layer of the aforementioned drug-loaded coating 120 can be hormonal or anti-inflammatory drugs, and the sustained-release drug is used to promote endometrial repair. In this embodiment, the thickness of the drug-loaded coating 120 is 0.5-2 times the diameter of the nickel-titanium alloy wire, which ensures that a sufficient dose of sustained-release drug is uniformly mixed within the coating.

[0035] To further optimize the fit and practicality of the support frame 110, symmetrical arc-shaped protruding ears 130 are formed on opposite sides of the opening at the distal end (near the fundus) of the support frame 110. These protruding ears 130 can match the concave structure of the uterine horn within the uterine cavity 300, allowing for precise embedding into the uterine horn area and solving the problem of incomplete coverage of the uterine horn by existing instruments, thus achieving complete isolation of the entire uterine cavity 300 without blind spots. In this embodiment, each protruding ear 130 is formed by combining two symmetrically arranged petal-shaped components 111. The protruding ears 130 also ensure the positioning stability of the support frame 110 within the uterine cavity 300. A flexible tail 140 is provided at the proximal end (near the cervix) of the support frame 110 for withdrawing the treatment unit 100 from the uterine cavity 300. The end of the flexible tail 140 extends to the vicinity of the external os of the cervix. After treatment, the treatment unit 100 can be removed by pulling the flexible tail 140 without additional surgical procedures, reducing patient discomfort.

[0036] The flap-shaped component 111 is made of medical-grade nickel-titanium alloy with a wire diameter ranging from 0.02mm to 1mm. Each flap-shaped component 111 has only one support frame structure at its outermost contour position. This support structure has good memory and elasticity, and it is also convenient to determine the shape of the overall support skeleton 110 after unfolding during processing. Its shape is a three-dimensional structure with an arc, unfolding to both sides in an inverted raindrop shape. This structural design allows the flap-shaped component 111 to better conform to the arc contour of the uterine cavity 300 sidewall when expanded, avoiding local gaps. At the same time, the larger end of the inverted raindrop shape can cover a larger area of ​​the uterine fundus, further improving the wound isolation effect. In other embodiments, the flap-shaped component 111 can also be made of polymer materials or biodegradable materials.

[0037] like Figure 4-7 As shown, the delivery unit 200 includes a delivery catheter 210, a push rod 220, and a positioning ring 230. The delivery catheter 210 is made of medical-grade polyethylene, with an outer diameter ranging from 2mm to 10mm and a length from 10cm to 20cm. The diameter of the catheter is adapted to the treatment unit 100 in its compressed state. Its distal end features a rounded chamfer design to avoid damage to the cervix and uterine cavity 300 tissues during delivery. The treatment unit 100 is tightly arranged within the lumen of the delivery catheter 210 in its compressed state. The push rod 220... The length of the push rod 220 is greater than the length of the delivery catheter 210. Its distal end is slidably disposed in the lumen of the delivery catheter 210 and detachably connected to the proximal end of the treatment unit 100. Specifically, the distal end of the push rod 220 has a cylindrical groove-shaped fixing structure 250. During delivery, the proximal end of the treatment unit 100 is limited inside the fixing structure 250. After the treatment unit 100 is delivered into the uterine cavity 300, the treatment unit 100 can be detached from the fixing structure 250 to facilitate the release of the treatment unit 100. The proximal end of the push rod 220 extends to the outside of the delivery catheter 210 and is provided with a handle 240. By pushing the handle 240, the push rod 220 can be driven to push the treatment unit 100 out from the distal end of the delivery catheter 210, so that the treatment unit 100 can expand and unfold autonomously within the uterine cavity 300. The positioning ring 230 is slidably disposed on the outside of the delivery catheter 210 and can be adjusted according to the depth of the patient's uterine cavity 300. When the distal end of the delivery catheter 210 is pushed to the target position in the uterine cavity 300, the positioning ring 230 fits against the external os of the cervix, limiting the pushing depth of the delivery catheter 210 and avoiding damage to the fundus tissue due to pushing too deep or positioning deviation of the treatment unit 100 due to pushing too shallow.

[0038] Furthermore, in order to facilitate the determination of the unfolded state of the compressed treatment unit 100 (e.g., the orientation of the protruding ear 130 after unfolding), the positioning ring 230 is designed to be elliptical. This way, when the treatment unit 100 is placed inside the delivery catheter 210, the long axis of the treatment unit 100 is aligned parallel to the long axis of the positioning ring 230. Thus, during the operation, the unfolded state of the treatment unit 100 can be determined by the display state of the outer positioning ring 230.

[0039] The usage process of this embodiment is as follows: First, the depth of the patient's uterine cavity 300 is measured using a measuring device (e.g., hysteroscopy / ultrasound). The position of the positioning ring 230 on the delivery catheter 210 is adjusted so that the distance from the distal end of the delivery catheter 210 to the positioning ring 230 is equal to the depth of the uterine cavity 300. The treatment unit 100 is compressed so that the flap-shaped component 111 is brought towards the center. After the volume is reduced, it is inserted into the lumen of the delivery catheter 210, ensuring that the distal end of the treatment unit 100 faces the distal end of the delivery catheter 210.

[0040] like Figure 8 As shown, the distal end of the delivery catheter 210 is slowly pushed into the uterine cavity 300 until the positioning ring 230 is aligned with the external os of the cervix, at which point the pushing is stopped; Figure 9 As shown, slowly push the handle 240 of the push rod 220 (or keep the push rod 220 in place) while slowly withdrawing the delivery catheter 210 outwards, pushing the treatment unit 100 out from the distal port of the delivery catheter 210; as Figure 10 As shown, the treatment unit 100 expands autonomously within the uterine cavity 300 using the memory-based structure of a nickel-titanium alloy frame. The flap-shaped component 111 gradually unfolds to form a cup-shaped structure, the protruding ear 130 conforms to the uterine horn, and the drug-loaded covering 120 makes full contact with the wound surface of the uterine cavity 300. After the push rod 220 is fully extended, the delivery catheter 210 and the push rod 220 are slowly withdrawn. Figure 11 As shown, the flexible tail 140 ends are left 1-2 cm outside the external os of the cervix, and the excess part is cut off with a cutting tool 400. During treatment, the flexible tail 140 should be kept clean and pulled to avoid traction. After the treatment cycle is set, use the clamping tool 500 to gently clamp the flexible tail 140 and slowly pull to remove the treatment unit 100 from the uterine cavity 300. During the removal process, the treatment unit 100 is automatically compressed by the cervix, making it easy to withdraw smoothly.

[0041] Example 2 like Figure 14As shown, the core difference between this embodiment and Embodiment 1 lies in the structure of the petal-shaped component 111. In Embodiment 1, each petal-shaped component 111 has only one outermost support frame structure. In this embodiment, each petal-shaped component 111 has two layers of support frame structures. This improves the overall support strength of the petal-shaped component 111 and ensures that the drug-loaded membrane 120 can further and fully contact the sidewall of the uterine cavity 300. The remaining basic structures (such as the shape of the support frame 110 and the design of the delivery unit 200) are consistent with Embodiment 1 and will not be described in detail here.

[0042] Example 3 like Figure 15 As shown, the core difference between this embodiment and embodiment 1 lies in the arrangement of the drug-loaded coating 120. That is, each petal-shaped component 111 of the support frame 110 is independently provided with a drug-loaded coating 120. All support frames 110 are assembled together by fixing seats 150. The remaining basic structures (such as the shape of the support frame 110 and the design of the delivery unit 200) are consistent with embodiment 1 and will not be described in detail here.

[0043] Specifically, the support frame 110 is composed of multiple petal-shaped components 111, which overlap with each other. Any two adjacent petal-shaped components 111 slide together to make the entire product structure gapless, which is used to isolate adhesion tissue. The material and shape of the petal-shaped components 111 are the same as in Example 1, but each petal-shaped component 111 has an independent drug-loaded coating 120 on its outer wall. The shape of each petal-shaped component 111 varies depending on the assembly position. The distal opening of the support frame 110 still has symmetrically arranged arc-shaped protruding ears 130 on both sides. The petal-shaped components 111 used to form the protruding ears 130 are longer than the petal-shaped components 111 in other positions to adapt to the uterine cavity 300 uterine horn shape; the flexible tail 140 is fixedly set at the proximal end of the fixing seat 150, and other parameters are the same as in Example 1 to ensure convenient removal.

[0044] The size of the drug-loaded coating 120 on each petal component 111 matches the shape of the petal component 111 itself.

[0045] The distal end face of the fixation base 150 has multiple slots for engaging the valve-shaped component 111. Each valve-shaped component 111 has a buckle that engages with the slot. Specifically, when assembling the treatment unit 100, the valve-shaped component 111 and the fixation base 150 are assembled and fixed by engaging the buckle with the slot.

[0046] The treatment unit 100 designed in this way has the following advantages: (1) Higher compatibility with uterine cavity size 300: The product structure can be assembled into a finished product by selecting different numbers of petal-shaped parts 111 according to the size of uterine cavity 300 before the operation, thereby improving the compatibility of the product with different uterine cavity size 300.

[0047] (2) Improve the intraoperative error tolerance: The valve component 111 is an independent individual that can be disassembled. After the product is implanted, the number of valve components 111 can be increased or decreased at any time to form a new finished product, thus solving the problem of small product specifications due to insufficient preoperative assessment.

[0048] (3) Reduce pressure on the uterine cavity 300 wall: When the uterine cavity 300 is found to be small, a partial flap component 111 can be implanted. The flap component 111 can be added later according to clinical needs, which can reduce the problem of pressure damage to the inner wall of the uterine cavity 300 caused by the implanted stent being too large.

[0049] (4) Easy to transport: When the uterine cavity 300 is large and more valve-shaped components 111 are required, if more valve-shaped components 111 are required, the whole structure is not easy to compress, which will increase the difficulty of transport. In this embodiment, since the treatment unit 100 can be disassembled and reassembled after implantation, the valve-shaped components 111 can be implanted in batches during the operation, which effectively reduces the difficulty of transport.

[0050] (5) Large isolation area: Since the entire treatment unit 100 is composed of individual covered flap components 111, and any two adjacent flap components 111 slide together to make the entire product structure more compact, it can be used to isolate the largest area of ​​adhesion tissue.

[0051] Example 4 like Figure 16 As shown, the core difference between this embodiment and Embodiment 1 is that the support frame 110 in the expanded state is formed by multiple petal-shaped components 111 enclosing a three-dimensional lotus-shaped structure that is larger at the top and smaller at the bottom. At this time, each protruding ear 130 on both sides is formed by a combination of a petal-shaped component 111 located at the edge. The remaining basic structures (such as the shape of the support frame 110 and the design of the conveying unit 200) are consistent with Embodiment 1 and will not be described in detail here.

[0052] In summary, this device, through structural innovation and functional optimization, effectively compensates for the shortcomings of existing technologies, significantly reduces the recurrence rate after intrauterine adhesion surgery, and improves the endometrial repair effect and patient treatment experience. It provides a safe, efficient, and precise new option for the prevention and treatment of intrauterine adhesion surgery, and has important clinical application value and industrialization prospects.

[0053] It is understood that the above description is merely exemplary and the embodiments of this application do not limit the scope of the application.

[0054] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention are within the protection scope of the present invention.

Claims

1. A multi-valve uterine cavity anti-adhesion treatment device, characterized in that, The treatment unit (100) includes a treatment unit (100) and a delivery unit (200). The treatment unit (100) has a support frame (110) and a drug-loaded coating (120). The support frame (110) is composed of multiple valve-shaped components (111). Each valve-shaped component (111) has a large end and a small end of different sizes. The small ends of all valve-shaped components (111) are connected together. The support frame (110) has a compressed state and an expanded state. In the expanded state, the support frame (110) is formed by multiple valve-shaped components (111) enclosing a three-dimensional structure that is larger at the top and smaller at the bottom. Any two adjacent valve-shaped components (111) can move and cooperate so that the volume of the support frame (110) in the expanded state changes with the change of the uterine cavity (300). The drug-loaded membrane (120) is arranged on the support frame (110); the drug-loaded membrane (120) contains a sustained-release drug to promote the repair of the endometrium; The delivery unit (200) is used to load the treatment unit (100) in the contracted state and to deliver the treatment unit (100) to the target location to complete the release.

2. The multi-valve uterine cavity anti-adhesion treatment device according to claim 1, characterized in that, The petal-shaped component (111) is a three-dimensional structure with an arc, which unfolds to both sides in the shape of an inverted raindrop.

3. The multi-valve uterine cavity anti-adhesion treatment device according to claim 1, characterized in that, The support frame (110) has symmetrically formed arc-shaped protruding ears (130) on both sides opposite to the opening position at the distal end, so that the support frame (110) can fully fit the uterine cavity (300).

4. The multi-valve uterine cavity anti-adhesion treatment device according to claim 1, characterized in that, The support frame (110) is provided with a flexible tail (140) at its proximal end for withdrawing the treatment unit (100) from the uterine cavity (300).

5. The multi-valve uterine cavity anti-adhesion treatment device according to claim 1, characterized in that, The drug-loaded coating (120) has at least one sustained-release layer, and at least one drug is uniformly distributed in each sustained-release layer.

6. The multi-valve intrauterine anti-adhesion treatment device according to any one of claims 1-5, characterized in that, The drug-loaded coating (120) on the outer side of all the said petal-shaped components (111) is integrally formed.

7. The multi-valve intrauterine anti-adhesion treatment device according to any one of claims 1-5, characterized in that, Each of the petal-shaped components (111) of the support frame (110) is independently provided with a drug-loaded coating (120).

8. The multi-valve intrauterine anti-adhesion treatment device according to claim 7, characterized in that, The support frame (110) has a fixing seat (150) at the bottom, and each of the petal-shaped components (111) is detachably connected to the fixing seat (150).

9. The multi-valve intrauterine anti-adhesion treatment device according to claim 8, characterized in that, The inner wall of the fixing seat (150) is provided with a slot, and the small end of the petal-shaped component (111) is provided with a buckle that matches the slot. The assembly and fixing of the petal-shaped component (111) are achieved through the cooperation of the buckle and the slot.

10. The multi-valve uterine cavity anti-adhesion treatment device according to claim 8, characterized in that, The delivery unit (200) includes a delivery conduit (210), a push rod (220), and a positioning ring (230). The treatment unit (100) is arranged in the lumen of the delivery conduit (210) in a compressed state. The push rod (220) is slidably disposed in the lumen of the delivery conduit (210) for pushing the treatment unit (100). The positioning ring (230) is slidably disposed on the outside of the delivery conduit (210) for limiting the pushing depth of the delivery conduit (210).

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