Organ fistula occlusion device and endoscopic device including same

Abstract

This organ fistula occlusion device comprises: a fistula occlusion film; and a catheter for moving the fistula occlusion film. The catheter comprises: a catheter tube; a guide member movably disposed inside the catheter tube so as to be insertable into and withdrawable from the catheter tube; and a deployment wire which is connected to an end of the guide member so as to be able to unfurl when discharged from the catheter tube, and to which the fistula occlusion film is attached. When the deployment wire is located at a fistula tissue site, the fistula occlusion film is separated from the deployment wire and attached to the fistula tissue site.

Description

Organ fistula occlusion device and endoscopic device including the same

[0001] The present invention relates to an organ fistula occlusion device and an endoscopic device including the same.

[0002] In general, xenotransplantation fistulas occur in various areas, including the digestive, genitourinary, and respiratory systems. Along with the occurrence of complications, xenotransplantation fistulas are emerging as a significant problem that lowers the quality of life.

[0003] Conventional fistula treatments primarily consist of surgical approaches or simple closure procedures. However, these conventional methods carry drawbacks such as high recurrence rates, damage to surrounding tissues, and delayed functional recovery after treatment, making the development of new treatment technologies urgent.

[0004] In particular, the xenotransplantation fistula environment is characterized by diverse body fluids, continuous pressure, and complex anatomical structures, making it difficult to effectively deliver and maintain therapeutic agents. Furthermore, persistent inflammation and abnormal tissue regeneration in the surrounding tissues act as major factors hindering therapeutic efficacy.

[0005] To solve these problems, there is a need for technology that can effectively close fistulas while promoting the normal regeneration of surrounding tissues.

[0006] (Prior Art Literature)

[0007] (Patent Document 1) PCT Publication WO2007 / 090155 (Published Aug. 09, 2007)

[0008] Embodiments of the present invention were invented against the background described above, and aim to provide an organ fistula occlusion device capable of effectively occluding a fistula occurring in an organ, and an endoscopic device including the same.

[0009] A long-term fistula occlusion device according to one embodiment of the present invention comprises: a fistula occlusion film; and a catheter for moving the fistula occlusion film, wherein the catheter comprises a catheter tube; a guide member movably disposed inside the catheter tube so as to be inserted into and removed from the catheter tube; and a spreading wire connected to the end of the guide member so as to be unfolded when discharged from the catheter tube, to which the fistula occlusion film is attached, wherein the fistula occlusion film is separated from the spreading wire and attached to the fistula tissue when the spreading wire is positioned at the fistula tissue site where a fistula has occurred.

[0010] In addition, the fistula occlusion film may include a polymer layer attached to the development wire; a hydrogel layer capable of occluding the fistula; and a nanostructure layer disposed between the polymer layer and the hydrogel layer.

[0011] In addition, the hydrogel layer can be attached to the fistula tissue with a greater adhesive force than the adhesive force between the fistula occlusion film and the development wire when the development wire is positioned on the fistula tissue.

[0012] In addition, the nanostructure layer can form a three-dimensional nanostructure capable of hydrogen bonding and mechanical interlocking with the hydrogel layer by forming hydroxyl groups in the polymer layer through oxygen plasma treatment.

[0013] In addition, the above-mentioned unfolding wire may be composed of a shape-memory material that can unfold into a flower shape when discharged from the catheter tube and can converge and overlap inside the catheter tube when drawn into the catheter tube.

[0014] Additionally, the development wire comprises a main wire connected to the end of the guide member; and a plurality of sub-wires connected to the main wire at both ends and extending from the main wire to form a closed loop in a radial direction, and the plurality of development wires may be arranged adjacent to each other with respect to the main wire.

[0015] Additionally, the catheter may further include a sheath hub connected to the rear end of the catheter tube; a locking cap rotatably installed on the sheath hub to secure the guide member; and a pusher hub capable of moving the guide member so that the development wire enters and exits the catheter tube.

[0016] In addition, the catheter can be inserted into the endoscope body, and when inserted into and moved within the endoscope body, the fistula occlusion film can be brought forward or laterally toward the fistula tissue area depending on the direction adjustment of the endoscope body.

[0017] An endoscope device according to another embodiment of the present invention comprises: an endoscope body; and an organ fistula occlusion device configured to be movable with respect to the endoscope body, wherein the organ fistula occlusion device comprises: a fistula occlusion film; and a catheter for moving the fistula occlusion film, wherein the catheter comprises: a catheter tube; a guide member movably disposed inside the catheter tube so as to be inserted into and removed from the catheter tube; and a spreading wire connected to the end of the guide member so as to be unfolded when discharged from the catheter tube, to which the fistula occlusion film is attached, wherein the fistula occlusion film is separated from the spreading wire and attached to the fistula tissue when the spreading wire is positioned at the fistula tissue site where a fistula has occurred.

[0018] According to embodiments of the present invention, by applying a hydrogel with strong skin adhesion based on a silica three-dimensional nanostructure to a fistula tissue site where a fistula has occurred, there is an advantage of being able to provide a high surface area and mechanical strength and effectively close the fistula. In addition, there is an advantage of being able to increase the bonding strength with surrounding tissues, promote tissue regeneration, and provide an antibacterial effect to accelerate fistula healing.

[0019] In addition, according to the embodiments of the present invention, by using a hydrogel-based fistula occlusion film, there is an advantage of being able to provide an environment similar to surrounding tissues with high water content and biocompatibility.

[0020] FIG. 1 is a configuration diagram illustrating an endoscope device according to one embodiment of the present invention.

[0021] Figure 2 is a view taken along the line "II-II" of Figure 1.

[0022] FIG. 3 is a side view illustrating an organ fistula occlusion mechanism according to one embodiment of the present invention.

[0023] FIG. 4 is a front view illustrating an organ fistula occlusion mechanism according to one embodiment of the present invention.

[0024] Figure 5 is a cross-sectional view of the "VV" section of Figure 4 cut open.

[0025] FIG. 6 is an enlarged view illustrating the state in which a fistula occlusion film according to one embodiment of the present invention is attached to a tissue.

[0026] FIG. 7 is a diagram illustrating a state in which a portion of the development wire according to one embodiment of the present invention is discharged from the catheter tube.

[0027] Figure 8 is a diagram showing the state in which the entire development wire of Figure 7 has been discharged from the catheter tube.

[0028] Figure 9 is a diagram showing the state in which the development wire of Figure 8 is inserted into the catheter tube.

[0029] Hereinafter, specific embodiments for implementing the concept of the present invention will be described in detail with reference to the drawings.

[0030] In addition, in describing the present invention, if it is determined that a detailed description of related known components or functions may obscure the essence of the invention, such detailed description is omitted.

[0031] Furthermore, when it is mentioned that one component is 'connected' or 'supported' by another component, it should be understood that while it may be directly connected or supported by that other component, there may also be other components present in between.

[0032] The terms used in this specification are used merely to describe specific embodiments and are not intended to limit the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise.

[0033] Furthermore, it should be noted in advance that expressions such as "upper side," "lower side," and "side" in this specification are described based on the drawings, and may be expressed differently if the orientation of the object changes. For the same reason, some components in the attached drawings may be exaggerated, omitted, or schematically depicted, and the size of each component does not entirely reflect its actual size.

[0034] Additionally, terms including ordinal numbers, such as first, second, etc., may be used to describe various components, but such components are not limited by such terms. These terms are used solely for the purpose of distinguishing one component from another.

[0035] The meaning of "comprising" as used in the specification is to specify certain characteristics, regions, integers, steps, actions, elements, and / or components, and does not exclude the existence or addition of other specific characteristics, regions, integers, steps, actions, elements, components, and / or groups.

[0036] Hereinafter, the specific configuration of an organ fistula occlusion mechanism according to one embodiment of the present invention will be described.

[0037] Referring to FIGS. 1 and 2, an endoscope device (1) according to one embodiment of the present invention can be inserted into a person's body to check the condition of an organ inside the body. The endoscope device (1) may include an endoscope body (10), a washing tube (20), a lamp (30), a camera lens (40), and an organ fistula occlusion device (50).

[0038] The endoscope body (10) can support a flushing tube (20), a lamp (30), a camera lens (40), and an organ fistula occlusion device (50). The endoscope body (10) may have an elongated tube shape. The endoscope body (10) may be made of a flexible material.

[0039] The washing tube (20) may be a tube capable of washing an organ. The washing tube (20) may spray saline solution, etc. toward the organ. In this embodiment, the washing tube (20) is placed in the endoscope body (10), but is not limited thereto, and the washing tube (20) may be configured as a separate washing device in addition to the endoscope body (10).

[0040] The lamp (30) can irradiate light onto an organ inside the body. The lamp (30) can be placed at the end of the endoscope body (10). The lamp (30) can irradiate light in the direction in which the camera lens (40) is taking a picture.

[0041] The camera lens (40) may be a lens capable of photographing the condition of organs inside the body. The camera lens (40) may be exposed at the end of the endoscope body (10). For example, the camera lens (40) may be a bendable, long special lens placed inside the endoscope body (10).

[0042] Referring further to FIGS. 3 to 6, the organ fistula occlusion device (50) can be moved to the fistula tissue area (F) where the fistula (H) has occurred and can close the fistula (H) with a fistula occlusion film (200). This organ fistula occlusion device (50) may include a catheter (100) and a fistula occlusion film (200).

[0043] The catheter (100) can move the fistula occlusion film (200) to the fistula tissue area (F) where the fistula (H) has occurred. The catheter (100) can be inserted into the endoscope body (10), and while the catheter (100) is inserted into the endoscope body (10), the endoscope body (10) can move the fistula occlusion film (200) to the vicinity of the fistula tissue area (F). When the catheter (100) is moved to the vicinity of the fistula tissue area (F) by the endoscope body (10), the catheter (100) can move the fistula occlusion film (200) to the fistula tissue area (F) precisely. The catheter (100) may include a catheter tube (110), a guide member (120), a deployment wire (130), a sheath hub (140), a locking cap (150), and a pusher hub (160).

[0044] The catheter tube (110) may provide a path through which the guide member (120) and the fistula occlusion film (200) can move. The catheter tube (110) may be provided in a tubular shape having an inner diameter larger than the outer diameter of the guide member (120). The rear end of the catheter tube (110) may be connected to a sheath hub (140). An opening may be formed at the front end of the catheter tube (110) through which the guide member (120) and the fistula occlusion film (200) can enter and exit. When the guide member (120) and the fistula occlusion film (200) are drawn into the interior of the catheter tube (110) through the front end of the catheter tube (110), the guide member (120) may be understood as being recaptured into the catheter tube (110).

[0045] A guide member (120) can be movably positioned inside a catheter tube (110). One end of the guide member (120) can be connected to a deployment wire (130), and the other end of the guide member (120) can be connected to a pusher hub (160). When the guide member (120) is pushed or pulled by the pusher hub (160), the guide member (120) can be moved in and out of the catheter tube (110).

[0046] The unfolding wire (130) can be connected to the end of the guide member (120). The unfolding wire (130) can be made of a shape memory material. The unfolding wire (130) can be formed in a flower shape. When the unfolding wire (130) is inserted into the catheter tube (110), the unfolding wire (130) can maintain a converged and overlapping state inside the catheter tube (110). When the unfolding wire (130) is discharged from the catheter tube (110), the unfolding wire (130) can unfold into its original flower shape. A fistula occlusion film (200) can be attached to the unfolding wire (130). The unfolding wire (130) may include a main wire (131) and a sub-wire (132).

[0047] The main wire (131) can be positioned between the guide member (120) and the sub-wire (132). One end of the main wire (131) can be connected to the end of the guide member (120), and the other end of the main wire (131) can be connected to both ends of the sub-wire (132). The ends of a plurality of sub-wires (132) can be converged and connected to the other end of the main wire (131).

[0048] The sub-wire (132) may be formed by extending from the main wire (131) to form a closed loop in a radial direction. Both ends of the sub-wire (132) may be connected to the main wire (131). The sub-wire (132) may be provided in multiple numbers. Multiple development wires (130) may be arranged adjacent to each other with respect to the main wire (131). For example, multiple development wires (130) may form a closed loop in a flower shape with respect to the main wire (131).

[0049] The sheath hub (140) may be positioned at the rear end of the catheter tube (110). A movable space in which a guide member (120) can move may be formed inside the sheath hub (140). The sheath hub (140) may be configured to correspond to a conventional sheath hub (140) configuration used in a catheter (100). The sheath hub (140) may be equipped with a locking cap (150).

[0050] The locking cap (150) can selectively fix the movement of the guide member (120). The locking cap (150) can be rotatably installed on the sheath hub (140) to fix the guide member (120). When the locking cap (150) is rotated in one direction, the locking cap (150) can fix the movement of the guide member (120), and when the locking cap (150) is rotated in the other direction, the locking cap (150) can release the fixation to the guide member (120).

[0051] The pusher hub (160) can push or pull the guide member (120). The pusher hub (160) can be connected to the deployment wire (130). When the pusher hub (160) is pushed, the guide member (120) can be discharged from the front end of the catheter tube (110), and when the pusher hub (160) is pulled, the guide member (120) can be drawn into the interior of the catheter tube (110).

[0052] The fistula occlusion film (200) may be provided in the form of a film that can be attached to a fistula tissue area (F) where a fistula (H) has occurred. When the spreading wire (130) is positioned at the fistula tissue area (F), the fistula occlusion film (200) may be separated from the spreading wire (130) and attached to the fistula tissue area (F). The fistula occlusion film (200) may include a polymer layer (210), a hydrogel layer (220), and a nanostructure layer (230).

[0053] A polymer layer (210) can be attached to a development wire (130). The polymer layer (210) may be a polymer material in which molecules are polymerized together as repeating basic units. The polymer layer (210) may include polymer components such as polymethyl methacrylate (PMMA) or polyurethane (PU). A nanostructure layer (230) may be formed on the upper side of the polymer layer (210). The thickness of the polymer layer (210) may be provided in the range of about 10 to 1000 μm (e.g., 10 to 100 μm or 100 to 1000 μm).

[0054] The hydrogel layer (220) may include a hydrogel in which a water-soluble polymer forms a three-dimensional structure through physical or chemical bonding. The hydrogel layer (220) can regenerate tissue by maintaining an appropriate amount of exudate outflow. When the spreading wire (130) is positioned at the fistula tissue area (F), the hydrogel layer (220) can be attached to the fistula tissue area (F) with an adhesive force greater than the adhesive force between the fistula occlusion film (200) and the spreading wire (130). With the hydrogel layer (220) attached to the fistula tissue area (F), the fistula (H) of the fistula tissue area (F) can be occluded. The hydrogel layer (220) may have a thickness of about 1 to 500 μm.

[0055] The nanostructure layer (230) may be placed between the polymer layer (210) and the hydrogel layer (220). When the fistula occlusion film (200) is manufactured, the nanostructure layer (230) may be formed into a three-dimensional nanostructure capable of hydrogen bonding and mechanical interlocking with the hydrogel layer (220) by forming hydroxyl groups in the polymer layer (210) through oxygen plasma treatment. The thickness of the nanostructure layer (230) may be in the range of about 20 to 250 nm.

[0056] The thicknesses of the polymer layer (210), hydrogel layer (220), and nanostructure layer (230) can be set in correlation to improve the mechanical stability, tissue adhesion, and occlusion performance of the fistula occlusion film (200).

[0057] The polymer layer (210) may have a thickness of about 10 to 1000 μm, and this thickness range may be advantageous for preventing the film from being excessively crumpled or rolled up during the unfolding process, while simultaneously providing the flexibility required when applied to the fistula tissue area (F). For example, if the polymer layer (210) is formed to be 10 to 100 μm, flexibility increases, allowing for smooth unfolding even in narrow fistulas, and if it is formed to be 100 to 1000 μm, the structural rigidity of the film increases, which can improve the bonding stability with the unfolding wire (130).

[0058] The hydrogel layer (220) may have a thickness of about 1 to 500 μm, and this thickness range may be set to provide a balanced combination of adhesion to the fistula tissue area (F), exudate absorption capacity, and tissue regeneration promotion function. In particular, if the hydrogel layer (220) is thin, it can adhere quickly to the surface of the fistula, and if it is thick, the buffering and storage capacity for exudate increases, which can contribute to stably maintaining the occlusion of the fistula (H).

[0059] The nanostructure layer (230) may have a thickness of about 20 to 250 nm, and this thickness range may be suitable for stably forming a three-dimensional nanostructure for hydrogen bonding and mechanical interlocking between the polymer layer (210) and the hydrogel layer (220). If the thickness of the nanostructure layer (230) is sufficient, the bonding strength with the hydrogel layer (220) increases, which can prevent interlayer delamination and allow the film to be maintained stably even during initial unfolding.

[0060] In this way, by combining the thicknesses of the three layers, the fistula occlusion film (200) can be effectively transferred from the spreading wire (130) to the fistula tissue area (F), and the structural stability and adhesion for occluding the fistula (H) can be improved. In addition, various functions such as exudate management, tissue regeneration promotion, and maintenance of interlayer bonding strength can be performed in a balanced manner.

[0061] Additionally, the thicknesses of the polymer layer (210), hydrogel layer (220), and nanostructure layer (230) may be interrelated to improve the mechanical stability, tissue adhesion, and occlusion performance of the fistula occlusion film (200). The polymer layer (210) may have a thickness of about 10 to 1000 μm, and this thickness range may be advantageous for preventing the film from being excessively crumpled or rolled up during the unfolding process, while simultaneously providing the flexibility required when applied to the fistula tissue area (F). The hydrogel layer (220) may have a thickness of about 1 to 500 μm, and the nanostructure layer (230) may have a thickness of about 20 to 250 nm.

[0062] Additionally, the thickness of each layer may have the following relative size relationship. The polymer layer (210) may be formed relatively thicker than the hydrogel layer (220) to serve as a structural support for the entire film. On the other hand, the hydrogel layer (220) may be formed thinner than the polymer layer (210) while being configured to provide tissue adhesion and exudate management functions. The nanostructure layer (230) has a significantly smaller thickness (tens to hundreds of nanometers) compared to the polymer layer (210) and the hydrogel layer (220), and this thin thickness may be suitable for forming microstructures for surface modification and interlayer bonding.

[0063] That is, by forming a relative thickness structure in the order of the polymer layer (210), the hydrogel layer (220), and the nanostructure layer (230), each layer performs a functionally distinct role while maintaining a balance of mechanical performance and biocompatibility of the entire film. For example, the polymer layer (210) has sufficient thickness to provide a basis for the formation of the nanostructure layer (230), the nanostructure layer (230) improves the adhesion of the hydrogel layer (220) through micropores and roughness, and the hydrogel layer (220) can strengthen initial adhesion by maximizing the contact area with the tissue surface in a thin and flexible state.

[0064] In this way, by appropriately adjusting the relative ratio of the thickness of each layer, the fistula occlusion film (200) can simultaneously secure spreadability, tissue adhesion, interlayer bonding stability, and fistula occlusion ability.

[0065] Hereinafter, the manufacture, operation, and effects of the fistula occlusion film according to the present invention will be described in detail.

[0066] To manufacture a fistula occlusion film, a nanostructure layer is first formed on a polymer layer. To this end, the polymer substrate on which the nanostructure layer is to be formed can be washed by ultrasonically treating it with acetone, ethanol, isopropanol, etc., then rinsed with deionized water, and dried in an oven. The washed polymer substrate can be treated with oxygen plasma immediately before the synthesis of the nanostructure layer.

[0067] A plasma-treated polymer substrate is introduced into a reaction vessel containing deionized water, and the polymer substrate is stirred in the reaction vessel at a temperature of 60 to 80 ℃. After the base catalyst (triethanolamine) is dissolved, a cationic surfactant (cetyltrimetylammonium chloride), an anionic auxiliary spacer (sodium salicylate), and a silica precursor solution (tetraethylorthosilicate) are added and stirred. The polymer substrate with the formed nanostructure layer is rinsed several times with ethanol and deionized water to remove residual reactants.

[0068] In addition, to prepare a hydrogel precursor solution, polyvinyl alcohol is added to deionized water and dissolved by stirring at 95°C. Once stirring is complete, acrylic acid, α-ketoglutaric acid, polyethylene glycol dimethacrylate, and acrylic acid N-hydroxysuccinimide ester are added and stirred at room temperature. The prepared hydrogel precursor solution is stored away from ultraviolet light.

[0069] In addition, to form a hydrogel layer on the nanostructure layer, a polymer substrate with a nanostructure layer formed thereon is immersed in a hydrogel precursor solution via a dip-coating method and coated at a speed of 13 mm / min, or the hydrogel precursor solution is cast using a PDMS mold and cured under a UV lamp for 1 hour. Furthermore, to control the thickness of the nanostructure, the stirring time (10 minutes to 2 hours) after adding the silica precursor solution can be controlled, and to control the pore size of the nanostructure layer, the ratio of a base catalyst or anionic auxiliary spacer can be controlled.

[0070] The operation and effects of a long-term fistula occlusion mechanism having the configuration described above will be explained below.

[0071] Referring again to FIG. 1, the catheter (100) is inserted into the endoscope body (10), and the fistula occlusion film (200) can be moved to the vicinity of the fistula tissue area (F) by the endoscope device (1). When inserted into and moved within the endoscope body (10), the catheter (100) can bring the fistula occlusion film (200) closer to the fistula tissue area (F) in a forward or lateral direction depending on the direction adjustment of the endoscope body (10).

[0072] Referring to FIGS. 7 and 8, when the catheter (100) is positioned close to the fistula tissue area (F), the unfolding wire (130) can be discharged from the catheter tube (110) by pushing with the pusher hub (160). When the unfolding wire (130) is discharged from the catheter tube (110), the unfolding wire (130) can be unfolded into its original flower shape at the end of the catheter tube (110). When the unfolding wire (130) is unfolded into a flower shape, the fistula occlusion film (200) can be brought closer to the fistula tissue area (F) by the operation of the pusher hub (160) and adhere to the fistula (H) of the fistula tissue area (F). When the fistula occlusion film (200) adheres to the fistula (H) of the fistula tissue area (F), the fistula occlusion film (200) can be separated from the unfolding wire (130).

[0073] Referring to FIG. 9, when the fistula occlusion film (200) is separated from the expansion wire (130), the expansion wire (130) can be recaptured into the catheter tube (110) by pulling of the pusher hub (160). When the expansion wire (130) is recaptured into the catheter tube (110), the expansion wire (130) overlaps while converging toward the center, so the expansion wire (130) can be smoothly recaptured into the catheter tube (110). Once the expansion wire (130) is recaptured into the catheter tube (110), after checking the attachment status of the fistula occlusion film (200) to the fistula tissue area (F), the catheter (100) can be moved out through an endoscope device.

[0074] As described above, the present invention has the advantage of being able to provide a high surface area and mechanical strength and effectively close the fistula by applying a hydrogel with strong skin adhesion based on a silica 3D nanostructure to the tissue area where the fistula has occurred. In addition, it has excellent advantages such as being able to increase bonding strength with surrounding tissue, promote tissue regeneration, accelerate fistula healing by providing an antibacterial effect, and provide an environment similar to the surrounding tissue through high water content and biocompatibility by using a hydrogel-based fistula occlusion film.

[0075] Although the embodiments of the present invention have been described above as specific embodiments, they are merely examples and the present invention is not limited thereto, but should be interpreted as having the broadest scope in accordance with the basic concept disclosed in this specification. Those skilled in the art may implement patterns of shapes not specified by combining or substituting the disclosed embodiments, and this also does not deviate from the scope of the present invention. Furthermore, those skilled in the art may easily modify or alter the disclosed embodiments based on this specification, and it is evident that such modifications or alterations also fall within the scope of the rights of the present invention.

Claims

1. Fistula occlusion film; and It includes a catheter for moving the above fistula occlusion film, and The above catheter catheter tube; A guide member movably disposed inside the catheter tube so as to be able to enter and exit the catheter tube; and It includes a deployment wire connected to the end of the guide member so as to be unfolded when discharged from the catheter tube, to which the fistula occlusion film is attached, The above fistula occlusion film is When the above-mentioned expansion wire is positioned on the tissue portion where the fistula has occurred, the portion separated from the above-mentioned expansion wire and attached to the tissue portion where the fistula has occurred Organ fistula occlusion device.

2. In Paragraph 1, The above fistula occlusion film is A polymer layer attached to the above-mentioned development wire; A hydrogel layer capable of blocking the above fistula; and A nanostructure layer disposed between the polymer layer and the hydrogel layer, Organ fistula occlusion device.

3. In Paragraph 2, The above hydrogel layer When the above-mentioned spreading wire is positioned in the above-mentioned fistula tissue area, it is attached to the above-mentioned fistula tissue area with an adhesive force greater than the adhesive force between the above-mentioned fistula occlusion film and the above-mentioned spreading wire, Organ fistula occlusion device.

4. In Paragraph 2, The above nanostructure layer By forming hydroxyl groups in the polymer layer through oxygen plasma treatment, a three-dimensional nanostructure capable of hydrogen bonding and mechanical interlocking with the hydrogel layer is formed. Organ fistula occlusion device.

5. In Paragraph 1, The above development wire is Composed of a shape-memory material that can unfold into a flower shape when discharged from the catheter tube and can converge and overlap inside the catheter tube when inserted into the catheter tube. Organ fistula occlusion device.

6. In Paragraph 1, The above development wire is A main wire connected to the end of the guide member; and It includes a plurality of sub-wires that are formed by extending from the main wire, with both ends connected to the main wire and forming a closed loop in a radial direction. Multiple deployment wire sections Arranged adjacent to each other with the main wire mentioned above as the center, Organ fistula occlusion device.

7. In Paragraph 1, The above catheter A sheath hub connected to the rear end of the above catheter tube; A locking cap rotatably installed on the sheath hub to secure the guide member; and A pusher hub further comprising the guide member capable of moving the guide member so that the development wire is inserted into and removed from the catheter tube. Organ fistula occlusion device.

8. In Paragraph 1, The above catheter It can be inserted into the endoscope body, When inserted into and moved within the endoscope body, the fistula occlusion film can be brought forward or laterally toward the fistula tissue area depending on the direction adjustment of the endoscope body. Organ fistula occlusion device.

9. Endoscope body; and It includes an organ fistula occlusion device configured to be movable with respect to the above-mentioned endoscope body, and The above-mentioned organ fistula occlusion mechanism is, Fistula occlusion film; and It includes a catheter for moving the above fistula occlusion film, and The above catheter catheter tube; A guide member movably disposed inside the catheter tube so as to be able to enter and exit the catheter tube; and It includes a deployment wire connected to the end of the guide member so as to be unfolded when discharged from the catheter tube, to which the fistula occlusion film is attached, The above fistula occlusion film is When the above-mentioned expansion wire is positioned on the tissue portion where the fistula has occurred, the portion separated from the above-mentioned expansion wire and attached to the tissue portion where the fistula has occurred Endoscope device.

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