Cavity closing device

Abstract

The utility model provides a cavity closing device. The cavity closing device comprises a conveying catheter, a plugging element and closing glue, wherein the plugging element is arranged at the far end of the conveying catheter through detachable design, and the conveying catheter conveys the plugging element into a cavity to be closed; the plugging element expands or expands in the cavity channel to be closed until the diameter of the plugging element is equal to or slightly larger than that of the cavity channel, so that fluid in the cavity channel is blocked, a semi-closed or closed space is formed, and the closing glue is convenient to release; the closing glue is injected into an area formed by the plugging element and the to-be-closed cavity along the interior of the conveying catheter, and is cured and adhered to the plugging element and the inner wall of the cavity; and after the closing glue completes plug plugging of the cavity, the conveying catheter is released from the plugging element and withdrawn. The glue releasing device can release and solidify glue in a fixed area, and is of great significance to improvement of treatment effect and safety.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a cavity closure device. Background Technology

[0002] In the field of medical devices, the permanent occlusion or closure of perforated or non-perforated cavities in the human body caused by tumors, varicose veins, heart defects, etc., has always been an important topic in medical research and clinical practice. The following is a detailed description of existing treatment methods and their limitations for the three main scenarios mentioned above:

[0003] 1. Tumor embolization therapy

[0004] Tumor embolization therapy is a method to inhibit tumor growth by blocking the blood supply arteries to the tumor. Traditional embolic agent spraying techniques have limitations; the embolic agent may not accurately target the blood vessel due to blood flow, resulting in poor embolization of branch vessels. Furthermore, uneven distribution of the embolic agent may lead to off-target embolization, increasing surgical risks. In recent years, hydrogel embolic agents have emerged as a novel embolic material, improving the visibility and predictability of embolization due to their ability to act as drug delivery carriers. However, they still face the risks of uneven embolic agent distribution and off-target embolization.

[0005] 2. Treatment of varicose veins

[0006] Varicose veins are a common disease of the lower extremity venous system. Traditional treatments include surgical removal and sclerotherapy. However, if the sclerotherapy agent fails to completely solidify before flowing away, it can easily cause thrombosis, endangering life. While endovenous laser therapy has the advantages of being minimally invasive and having a rapid recovery, its closure rate varies and may require multiple treatments. Furthermore, although mechanochemical endovenous ablation (MOCA) can promote fibrotic closure by mechanically and chemically destroying the venous endothelium, its potential complications include superficial thrombophlebitis and hematoma.

[0007] 3. Heart occlusion

[0008] Cardiac septal defects or patent septal defects (such as atrial septal defects, ventricular septal defects, and patent foramen ovale) are typically treated with occlusion discs or stents with similar functions. Commercially available occlusion discs are usually made of non-biodegradable metal. While they can close the defect, their metallic properties may affect cardiac electrical signal conduction, leading to complications such as arrhythmias. Furthermore, to ensure complete closure, occlusion discs are usually large, which can cause changes in myocardial structure, excessive local stress, and local inflammatory reactions, potentially leading to chronic cardiac changes such as arrhythmias and heart failure. Although biodegradable stents can alleviate long-term mechanical effects on the heart, intracardiac endothelialization is usually slow or incomplete. Degradation without complete endothelialization can not only lead to ineffective closure and recanalization, but also cause the disintegrating degradation products to become emboli, resulting in embolic complications such as pulmonary embolism and stroke. In summary, existing treatment methods have certain limitations in achieving cavity occlusion or closure. Therefore, developing an adhesive release device that can release and solidify in a fixed area is of great significance for improving treatment efficacy and safety. Utility Model Content

[0009] The purpose of this invention is to address the shortcomings of the prior art by providing a miniaturized cavity closure device that achieves safe, effective, and simple complete sealing and closure of the target cavity by precisely releasing closure adhesive in the target area.

[0010] The cavity closure device of this invention includes: a delivery conduit, a sealing element, and a sealing adhesive. The delivery conduit delivers the sealing element to the cavity to be closed and also delivers the sealing adhesive. The sealing element expands within the target cavity, blocking the flow of liquid or gas within the cavity and preventing the sealing adhesive from escaping before it cures. The sealing adhesive adheres to the cavity tissue within the target area and fills the cavity. After the sealing adhesive cures, the delivery conduit detaches from the sealing element and is withdrawn, leaving the sealing element inside the cavity to ensure complete cavity closure.

[0011] To achieve the above objectives, this utility model provides a cavity closure device, comprising: a delivery conduit, a sealing element, and a sealing adhesive; wherein the sealing element is disposed at the distal end of the delivery conduit by a detachable design, and the delivery conduit delivers the sealing element to the cavity to be closed; the sealing element expands or inflates within the cavity to be closed until its diameter is equal to or slightly larger than the diameter of the cavity, thereby blocking the fluid within the cavity and forming a semi-closed or closed space, facilitating the release of the sealing adhesive; the sealing adhesive is injected along the inside of the delivery conduit into the area formed by the sealing element and the cavity to be closed, and solidifies and adheres to the sealing element and the inner wall of the cavity; after the sealing adhesive completes the embolization and sealing of the cavity, the delivery conduit is detached from the sealing element and withdrawn.

[0012] The length of the occlusion element is less than the length of the cavity to be closed. The occlusion element includes a proximal occlusion element for sealing the proximal opening of the target cavity. The occlusion element also includes a distal occlusion element for sealing the distal opening of the target cavity. The occlusion element, comprising both proximal and distal occlusion elements, simultaneously seals both the proximal and distal ends of the cavity to be closed, creating a closed space within the cavity.

[0013] Furthermore, the proximal and distal occlusion devices are spaced at a fixed distance of 5-50 mm. The distance between the proximal and distal occlusion devices is also adjustable to accommodate different closure lengths of cavities, and the spacing can be adjusted intraoperatively based on the anatomical structure of the cavity to be closed. Distance adjustment indicators are provided on the delivery catheter or handle to indicate the appropriate spacing between the proximal and distal occlusion devices.

[0014] Preferably, the delivery conduit includes an injection port, which includes a first injection port and a second injection port for releasing different components of the closure adhesive, respectively.

[0015] Furthermore, the occlusion element includes a functional coating comprising vesicles, which rupture to release their internal contents. The occlusion element also includes a microporous balloon; upon inflation and reaching a certain pressure, the micropores open to release the contents of the balloon. The occlusion element is a balloon comprising an inner balloon and an outer balloon. The inner balloon is preferentially inflated to provide closure; the outer balloon is preferably a microporous balloon. After the inner balloon is inflated, the closure adhesive is injected into the space between the inner and outer balloons, allowing it to penetrate the target cavity through the micropores of the outer balloon.

[0016] Preferably, the sealing adhesive is a single-component adhesive that is directly injected into the target area and then activated and cured in a specific manner. Alternatively, the sealing adhesive can be a two-component adhesive, comprising a first component and a second component; the first and second components need to be mixed in the target cavity before being activated and cured in a specific manner, making the release and curing of the sealing adhesive safer and more controllable.

[0017] The cavity closure device includes a contrast marker to indicate whether the sealing element has been successfully delivered to the closure area of ​​the target cavity and whether the target cavity has been successfully closed. The cavity closure device also includes a guidewire lumen to facilitate guiding the cavity closure device into the target cavity or performing other operations via a guidewire.

[0018] The significance of this invention lies in the development of a novel, miniaturized cavity closure device. By precisely releasing closure adhesive in the target area, it can achieve complete sealing and closure of the target cavity more safely, effectively, and simply. To make the above-mentioned objectives, features, and advantages of this invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0019] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0020] Figure 1(a) and Figure 1(b) are schematic diagrams of the cavity closure device and the release mechanism.

[0021] Figures 2(a), 2(b), and 2(c) are schematic diagrams of implementation methods for using the closure adhesive in conjunction with the proximal and distal sealing components.

[0022] Figures 3(a) and 3(b) are schematic diagrams of the distance between the proximal and distal sealing components.

[0023] Figures 4(a), 4(b), and 4(c) are schematic diagrams of embodiments of the functional coating containing vesicles.

[0024] Figures 5(a), 5(b), and 5(c) are schematic diagrams of implementation methods of the sealing element.

[0025] Figures 6(a), 6(b), and 6(c) are schematic diagrams of the implementation methods of micropores and injection ports.

[0026] Figure 7 A schematic diagram of an embodiment of a delivery catheter with a guidewire lumen configured.

[0027] Figures 8(a) and 8(b) are schematic diagrams of the implementation methods of atrial septal closure. Detailed Implementation

[0028] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0029] The present invention will now be described in further detail so that those skilled in the art can implement it based on the description.

[0030] First, please refer to Figures 1(a) and 1(b). Figures 1(a) and 1(b) are schematic diagrams of an embodiment of this utility model, showing the overall structure of the cavity closure device and its release process, including a delivery catheter 1, a sealing element 2, a sealing adhesive 3, a radiopaque marker 4, and a guidewire lumen 5. The sealing element 2 can detach from the delivery catheter 1. Figure 1(a) shows the cavity closure device in its undetached state. Figure 1(b) shows the cavity closure device in its detached state.

[0031] Figures 2(a), 2(b), and 2(c) illustrate the combined use of the sealing adhesive with the proximal occluder 21 and the distal occluder 22, as well as the design of the injection port 11. In Figures 2(a) and 2(b), the occlusion element 2 may only have the distal occluder 22 or the proximal occluder 21, used to seal the distal opening 62 or the proximal opening 61 of the cavity 6 to be closed, respectively. In Figure 2(c), the occlusion element 2 may have both the proximal occluder 21 and the distal occluder 22.

[0032] Figures 3(a) and 3(b) illustrate the spacing design between the proximal occluder 21 and the distal occluder 22, including fixed and adjustable spacing. Figure 3(a) shows the fixed spacing design, and Figure 3(b) shows the adjustable spacing design. Figure 3(b) also includes a distance adjustment indicator 12. Typically, the distance adjustment indicator 12 is set on the catheter using printing, laser marking, or other techniques, in the form of scales, punctuation marks, or special icons, to indicate the depth of instrument advancement and / or the spacing between different components.

[0033] Figures 4(a), 4(b), and 4(c) illustrate the design of the functional coating 23 and vesicle 231, as well as the process of vesicle rupture to release the closure adhesive. Figures 4(a), 4(b), and 4(c) respectively show vesicle 231, one component of the closure adhesive encapsulated within the vesicle, and different components of the closure adhesive encapsulated within the vesicle.

[0034] Figures 5(a), 5(b), and 5(c) illustrate different forms of occlusion elements, including an occlusion balloon 24, a membrane-covered occlusion disc 25, and an endcap 26. Figure 5(a) shows a single-layer occlusion balloon. Figure 5(b) shows a membrane-covered occlusion disc. Figure 5(c) shows an endcap.

[0035] Figures 6(a), 6(b), and 6(c) illustrate the design of the micropores (241) and the injection port (11), as well as the structure of the double-layered balloon, with an inner balloon 242 and an outer balloon 243. Figure 6(a) shows a single-layered micropore balloon, Figure 6(b) shows the double-layered balloon design, and Figure 6(c) is a schematic diagram of the micropore location.

[0036] Figure 7The delivery catheter 1 with guidewire lumen 5 is shown, as well as the location of imaging mark 4 and injection port 11 on delivery catheter 1.

[0037] Figures 8(a) and 8(b) illustrate the specific application of this invention in atrial septal closure, including the use of the delivery catheter 1, the closure element 2, the closure adhesive 3, and the guide wire 92. Figures 8(a) and 8(b) respectively demonstrate specific applications using long tunnel-type patent foramen ovale as examples.

[0038] This invention first introduces its basic structure and usage. It provides a cavity closure device, comprising a delivery conduit 1, a sealing element 2, and a sealing adhesive 3. The distal end of the delivery conduit 1 is connected to the sealing element 2, which is used to deliver the sealing element 2 into the cavity 6 to be closed. The sealing element 2 can expand or inflate within the cavity 6 until its diameter is equal to or slightly larger than the cavity diameter, thereby blocking the fluid within the cavity and forming a semi-closed or closed space. This facilitates the release of the sealing adhesive 3 and prevents it from escaping into non-target areas before it is fully cured.

[0039] After the cavity is embolized and sealed, the delivery catheter 1 can be detached from the sealing element 2 and withdrawn by means of mechanical release, thermal release, or electrical release, so that the sealing element 2 and the sealing adhesive 3 remain in the cavity, achieving a permanent or temporary closure effect.

[0040] The following section introduces different configurations of the blocking elements.

[0041] (1) Single sealing component configuration

[0042] Referring to Figures 2(a) and 2(b), the sealing element 2 may consist of only a distal sealing element 22 or a proximal sealing element 21, used to seal the distal opening 62 or the proximal opening 61 of the cavity 6 to be closed, respectively. This configuration is suitable for cases where the fluid flows in one direction within the cavity; for example, when the fluid flows from the proximal end to the distal end, the distal sealing element 22 is used; when the fluid flows from the distal end to the proximal end, the proximal sealing element 21 is used.

[0043] (2) Dual-seal configuration

[0044] Referring to Figure 2(c), the occlusion element 2 can simultaneously include a proximal occlusion element 21 and a distal occlusion element 22. After entering the cavity 6 to be closed, the proximal and distal occlusion elements expand to a diameter slightly larger than or equal to the inner diameter of the cavity 6 to be closed, thus forming a closed cavity between the distal opening 62 and the proximal opening 61. Subsequently, the closure adhesive 3 is released, filling the cavity and adhering to the inner wall of the cavity and the occlusion element 2, thereby completing the embolization of the cavity to be closed.

[0045] In the embodiments of this utility model, the spacing design of the blocking element has the following embodiments.

[0046] (1) Fixed spacing design

[0047] Referring to Figure 3(a), the spacing between the proximal occluder 21 and the distal occluder 22 is a fixed design. The appropriate spacing for the cavity closure device is typically selected based on the length of the cavity 6 to be closed. The preferred spacing is 1-50 mm to accommodate closure requirements for cavities of different lengths.

[0048] (2) Adjustable spacing design

[0049] Referring to Figure 3(b), the distance between the proximal occluder 21 and the distal occluder 22 is adjustable. The axis of the distal occluder 22 can slide relative to the axis of the proximal occluder 21. The surgeon can adjust the distance between the occluders during the operation according to the length and diameter of the patient's cavity, etc., based on the distance adjustment indicator 12 set on the catheter or handle, thereby improving the flexibility of the operation.

[0050] Functional coatings and vesicle design, combined with Figure 4a , Figure 4b , Figure 4c The outer layer of the occlusion element 2 is typically provided with a functional coating 23, which can serve a simple lubricating function, or, depending on the characteristics of the cavity or surgical requirements, can be enhanced with functions such as promoting endothelialization, inhibiting platelet aggregation, and preventing thrombosis. In some embodiments, the functional coating 23 contains multiple vesicles 231, which can rupture under specific pressure, temperature, light, or other conditions to release the substances inside the vesicles (i.e., the closure adhesive 3 or its components). For example, the surface of the occlusion balloon 24 is processed with a functional coating 23 containing vesicles 231. After the balloon is inflated, the vesicles rupture to release the closure adhesive 3, which directly adheres the occlusion balloon 24 to the inner wall of the cavity, thereby achieving the purpose of closing the cavity.

[0051] The blocking element has the following different forms of embodiments.

[0052] (1) Closure balloon

[0053] Referring to Figures 5(a) and 6(a), the occlusion element 2 can be an occlusion balloon 24, the material of which can be TPU, PET, nylon, PE, COPA, COPE, Pebax, silicone, polylactic acid copolymer, etc. The occlusion balloon (24) can be a single-layer balloon, a microporous balloon, or a double-layer balloon. The micropores 241 of the microporous balloon have a diameter between 0.1 and 1000 micrometers and are used to release the closure adhesive 3 or its components.

[0054] Occlusion balloons can be sized by inflating or inflating to accommodate cavities of different diameters. Compliant or semi-compliant balloons can also accommodate irregularly shaped cavities, making them flexible and universally applicable. In addition, because the balloon inflation process is relatively gentle, it causes less damage to surrounding tissues.

[0055] (2) Covered sealing plate

[0056] Referring to Figure 5(b), the sealing element 2 can be a membrane sealing disc 25, which includes a flow-blocking membrane and a sealing disc. The flow-blocking membrane is combined with the sealing disc by means of bonding, stitching, lamination, sintering, dipping, spraying, etc. The sealing disc preferably has a self-expanding design, which expands and unfolds after being delivered to the target cavity through the delivery conduit 1, and works with the flow-blocking membrane to achieve the sealing and closing effect.

[0057] Covered occlusion discs typically possess high mechanical strength, are not easily deformed, and can withstand significant intracavitary pressure, making them suitable for high-pressure environments and scenarios requiring long-term implantation. Furthermore, because the occlusion disc can be rapidly deployed, it simplifies surgical procedures and saves surgical time. Moreover, for cases requiring long-term implantation, the occlusion disc can be custom-designed according to the patient's cavity shape, providing a more precise occlusion effect.

[0058] (3) Plug

[0059] Referring to Figure 5(c), the sealing element 2 can be a plug 26, which is usually made of materials such as hydrogel or sponge and has the property of absorbing water and expanding. The plug 26 can be designed as a column, a ball, a teardrop, etc. After entering the cavity 6 to be closed, it absorbs water or is artificially injected to expand and fill the cavity.

[0060] Due to the high absorbency of its material, the plug can quickly absorb blood or other bodily fluids, rapidly filling and expanding without any other operations to reduce the fluid content in the cavity and form a stable sealing effect. It is convenient and simple to use, and has a significant advantage for cavities with small diameters. In addition, materials such as hydrogel and gelatin sponge have good biocompatibility and biodegradability, allowing for long-term implantation and gradual degradation in the body without the need for secondary surgery for removal.

[0061] The following sections will introduce several methods for releasing the sealing adhesive.

[0062] Referring to Figures 6(a) and 6(b), the closing adhesive 3 or its components can be released in the following manner:

[0063] Released via injection port 11 on delivery catheter 1; released via micropores 241 of occluded balloon 24; released via rupture of vesicles 231 in functional coating 23.

[0064] In some embodiments, the sealing adhesive 3 is a two-component adhesive, including a first component 31 and a second component 32, which are released through the first injection port 111 and the second injection port 112 on the delivery conduit 1, respectively, and then mixed and cured in the target cavity.

[0065] Imaging markers and guidewire lumen. Combined Figure 7The cavity closure device may also be equipped with a contrast marker 4 and a guidewire lumen 5. The contrast marker 4 can be visualized under ultrasound and / or X-ray to help the operator confirm the position of the delivery catheter 1 and / or the occlusion element 2 in the cavity and whether the cavity has been blocked or sealed. The guidewire lumen 5 can accommodate the guidewire, and the delivery catheter 1 can be pushed along the guidewire and into the target cavity, improving delivery efficiency.

[0066] The following describes a specific application scenario of one embodiment of this utility model. Referring to Figures 8(a) and 8(b), taking a long tunnel-type patent foramen ovale as an example, the secondary septum 91a on the right side and the primary septum 91b on the left side of the atrial septum are not completely closed, leaving a tunnel-shaped channel. In use, the guidewire 92 is first inserted into the foramen ovale, extending from the distal opening 62. Then, the delivery catheter 1 and the occlusion element 2 located at the distal end of the delivery catheter are inserted into the foramen ovale along the guidewire 92 through the guidewire lumen 5. After confirming the position of the occlusion element 2 using the imaging marker 4, the proximal occlusion element 21 and the distal occlusion element 22 are filled until the proximal opening 61 and the distal opening 62 are blocked, and sufficient closure adhesive 3 is injected into the area between them. After the closure adhesive has cured, the delivery catheter 1 is detached from the occlusion element 2 and withdrawn, leaving the occlusion element 2 in the cavity, achieving permanent closure.

[0067] Although embodiments of this utility model have been disclosed above, they are not limited to the applications listed in the specification and embodiments. It can be applied to various fields suitable for this utility model. Other modifications can be readily implemented by those skilled in the art. Therefore, without departing from the general concept defined by the claims and their equivalents, this utility model is not limited to the specific details and examples shown and described herein.

Claims

1. A cavity closure device, characterized in that... include: Delivery conduits, sealing elements, and sealing adhesive; The occlusion element is configured at the distal end of the delivery conduit via a detachable design, and the delivery conduit delivers the occlusion element into the cavity to be closed. The sealing element expands or inflates within the cavity to be closed until its diameter is equal to or slightly larger than the cavity diameter, thereby blocking the fluid within the cavity and forming a semi-closed or closed space to facilitate the release of the sealing adhesive. The sealing adhesive is injected into the area formed by the sealing element and the cavity to be closed along the inside of the delivery conduit, where it solidifies and adheres to the sealing element and the inner wall of the cavity. After the sealing adhesive completes the embolization and sealing of the cavity, the delivery conduit is released from the sealing element and withdrawn.

2. The cavity closure device according to claim 1, characterized in that, The length of the sealing element is less than the length of the cavity to be closed.

3. The cavity closure device according to claim 1, characterized in that, The occlusion element includes a proximal occlusion element, used to seal the proximal opening of the target cavity.

4. The cavity closure device according to claim 1, characterized in that, The occlusion element includes a distal occlusion element for sealing the distal opening of the target cavity.

5. The cavity closure device according to claim 1, characterized in that, The occlusion element includes a proximal occlusion element and a distal occlusion element, which simultaneously occludes the proximal and distal ends of the cavity to be closed, thereby forming a closed space within the cavity.

6. The cavity closure device according to claim 5, characterized in that, The proximal and distal sealing components are spaced at a fixed distance of 5-50 mm.

7. The cavity closure device according to claim 5, characterized in that, The proximal and distal occlusion devices have an adjustable spacing to accommodate different closure lengths of cavities. The spacing between the occlusion devices can be adjusted during the procedure according to the anatomical structure of the cavity to be closed. The delivery catheter or handle is equipped with a distance adjustment indicator to indicate the implementation spacing of the proximal and distal occlusion devices.

8. The cavity closure device according to claim 1, characterized in that, The delivery conduit includes an injection port, which includes a first injection port and a second injection port, for releasing different components of the closure adhesive, respectively.

9. The cavity closure device according to claim 1, characterized in that, The sealing element includes a functional coating comprising vesicles, which, upon rupture, release material from their interior.

10. The cavity closure device according to claim 1, characterized in that, The occlusion element includes a microporous balloon, which opens its micropores after being inflated and reaching a certain pressure, releasing the contents of the balloon.

11. The cavity closure device according to claim 1, characterized in that, The occlusion element is a balloon comprising an inner balloon and an outer balloon. The inner balloon is preferentially inflated to provide closure. The outer balloon is a microporous balloon. After the inner balloon is inflated, the closure adhesive is injected into the space between the inner and outer balloons, allowing it to penetrate into the target cavity through the micropores of the outer balloon.

12. The cavity closure device according to claim 1, characterized in that, The sealing adhesive is a single-component adhesive that is injected directly into the target area and then activated and cured in a specific manner.

13. The cavity closure device according to claim 1, characterized in that, The sealing adhesive is a two-component adhesive, comprising a first component and a second component. The first component and the second component need to be mixed in the target cavity and then activated and cured in a specific manner, making the release and curing of the sealing adhesive safer and more controllable.

14. The cavity closure device according to claim 1, characterized in that, The cavity closure device includes a imaging marker to indicate whether the sealing element has been successfully delivered to the area to be closed in the target cavity and whether the target cavity has been successfully closed.

15. The cavity closure device according to claim 1, characterized in that, The cavity closure device includes a guidewire lumen, which facilitates the guidance of the cavity closure device into the target cavity or for other operations via the guidewire.

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