Enclosed structure of a balloon, balloon system and method of manufacturing thereof

Abstract

This invention discloses a closure structure for a balloon, a balloon system, and a method for manufacturing the same. The balloon includes a balloon wall, and the closure structure includes a guide assembly that penetrates and connects to the balloon wall. The connection point between the guide assembly and the balloon wall serves as an interface for the balloon. The guide assembly has a guide channel configured to temporarily accommodate a guide, the guide channel including a first opening located on the outer side of the balloon wall, and the guide assembly including a first end located on the outer side of the balloon wall and surrounding the first opening. The closure structure of this invention can distribute the forces borne by the closure structure onto the balloon wall, ensuring good sealing after catheter withdrawal.

Description

Technical Field

[0001] This disclosure relates to a closure structure of a sac, a balloon system, and a method for manufacturing the same. Background Technology

[0002] In recent years, with the continuous improvement of living standards, the global incidence of obesity has shown a rapid upward trend. While bariatric surgery is highly effective, it is only suitable for a certain group of people, and a significant portion of those who meet the surgical criteria do not undergo the procedure. Other treatment methods (including diet control, exercise, and medication) generally have unsatisfactory results. Therefore, professionals, including doctors, have been searching for more effective methods of weight control.

[0003] Gastric balloons reduce energy intake in obese patients by occupying gastric contents, increasing satiety, and delaying gastric emptying. As a safe, effective, and convenient weight loss method, they have become popular and widely accepted in some countries.

[0004] During use, the balloon is inserted into the patient's stomach via endoscopy or swallowing. A guide, such as a catheter, is used to fill the balloon with gas or liquid to occupy the stomach's contents. Once the balloon is filled with gas or liquid, the catheter is withdrawn. Excessive withdrawal force may damage the sealing structure or the balloon itself, affecting the balloon's seal and leading to safety and effectiveness issues. Summary of the Invention

[0005] This disclosure provides a closure structure for a sac, a balloon system, and a method for manufacturing the same.

[0006] According to a first aspect of this disclosure, a closure structure for a sac is provided, the sac including a sac wall, the closure structure including: a guide assembly penetrating the sac wall and connected to the sac wall, the connection point on the sac wall to the guide assembly being an interface of the sac, the guide assembly having a guide channel configured to temporarily accommodate a guide, the guide channel including a first opening located outside the sac wall, the guide assembly including a first end located outside the sac wall and surrounding the first opening.

[0007] In at least some embodiments, the closure structure further includes: a side wing, the side wing including a first portion located outside the capsule wall and a second portion located inside the capsule wall; the guide channel further includes: a second opening located inside the capsule wall; the guide assembly further includes: a second end located inside the capsule wall and surrounding the second opening; wherein the first portion is connected to the first end and the second portion is connected to the second end.

[0008] In at least some embodiments, the guide channel penetrates the capsule wall and is perpendicular to the tangential plane of the capsule wall at the interface. The guide channel includes: a first channel portion and a second channel portion connected in a first direction, the first channel portion being located outside the capsule wall and defining the first opening, and the second channel portion being located inside the capsule wall and defining the second opening; the width of at least one of the first channel portion and the second channel portion increases in a direction away from the capsule wall.

[0009] In at least some embodiments, the guide channel further includes: a third channel portion connected between the first channel portion and the second channel portion, the width of the third channel portion remaining constant along the first direction; the first channel portion and the second channel portion are symmetrically arranged with respect to the third channel portion.

[0010] In at least some embodiments, the closure structure further includes a side wing parallel to the plane of the guide channel; the guide channel is perpendicular to the tangent plane of the capsule wall at the interface and includes: a first channel portion and a second channel portion connected in a first direction, and a third channel portion connecting the first channel portion and the second channel portion; the orthographic projection of the third channel portion in the plane of the side wing and the orthographic projection of the interface in the plane of the side wing at least partially overlap.

[0011] In at least some embodiments, the guide channel further includes: a boundary line located at the junction of the third channel portion and the first channel portion; the orthographic projection of the docking interface on the plane where the side wing is located falls on the side of the orthographic projection of the boundary line on the plane where the side wing is located closer to the second channel portion.

[0012] In at least some embodiments, the closure structure further includes a wing parallel to the plane of the guide channel; the guide channel penetrates the capsule wall and is perpendicular to the tangent plane of the capsule wall at the interface; the wing includes: a first end and a second end opposite to each other in a second direction, the first end being close to and connected to the guide assembly, and the second end being away from the guide assembly, wherein the second direction is perpendicular to the first direction; a portion of the first end is located outside the capsule wall.

[0013] In at least some embodiments, the wing further includes: a connecting portion connecting the first end and the second end, the connecting portion including a first outer edge and a second outer edge opposite to each other in a first direction, the first outer edge being located outside the capsule wall and the second outer edge being located inside the capsule wall; at least one of the first outer edge and the second outer edge is non-linear.

[0014] In at least some embodiments, the vertical distance between the first end and the second end in the second direction is d, and the vertical distance d satisfies the following condition:

[0015]

[0016] Where a is the dimension of the guide channel in the first direction, and e is the dimension of the guide component in the second direction.

[0017] In at least some embodiments, the guiding component is located between the first wall and the second wall and includes: a first flexible layer; and a second flexible layer, the second flexible layer being stacked on top of the first flexible layer in a thickness direction and partially connected to each other to define the guiding channel located between the first flexible layer and the second flexible layer, the thickness direction being perpendicular to the plane containing the side wing; wherein the opposing surfaces of the first flexible layer and the second flexible layer that at least partially define the guiding channel are self-adhesive; wherein at least one of the first flexible layer and the second flexible layer is connected to the side wing.

[0018] In at least some embodiments, at least one of the first flexible layer and the second flexible layer is made of the same material as the side wing and is an integral structure.

[0019] In at least some embodiments, the guide channel penetrates the interface and extends perpendicularly to the capsule wall in a first direction, and the side wings are parallel to the plane in which the guide channel is located; at least one of the first flexible layer and the second flexible layer includes a first side and a second side opposite to each other in a second direction parallel to the plane in which the side wings are located, the second direction being perpendicular to the first direction; the number of side wings is at least two, the at least two side wings are located on the first side and the second side respectively, and are connected to the flexible layer on the first side and the second side respectively.

[0020] In at least some embodiments, the guiding channel further includes: a second opening located inside the capsule wall; the guiding assembly further includes: a second end located inside the capsule wall and surrounding the second opening; the closure structure further includes: a flexible sleeve sleeved on and connected to the second end, the flexible sleeve having an opening, the flexible sleeve including a chamber communicating with the second opening, the chamber being configured to temporarily accommodate the guide.

[0021] In at least some embodiments, the guide channel extends in a first direction parallel to the plane of the side wing; a portion of the second end is located in the chamber, and the dimension of the portion of the second end in a second direction parallel to the plane of the side wing is smaller than the dimension of the chamber in the second direction parallel to the plane of the side wing, the second direction being perpendicular to the first direction.

[0022] In at least some embodiments, the flexible sleeve includes: a third flexible layer; and a fourth flexible layer, the third flexible layer and the fourth flexible layer being stacked in a thickness direction and partially connected to each other to define the cavity, the thickness direction being perpendicular to the plane containing the side wings.

[0023] In at least some embodiments, one of the third flexible layer and the fourth flexible layer is provided with the opening, the opening being configured to allow the guide located in the cavity to pass through and enter the sac.

[0024] According to a second aspect of this disclosure, a balloon system is provided, comprising: a bladder configured to be inflatable; and the aforementioned closed structure.

[0025] In at least some embodiments, the capsule wall includes a first wall and a second wall, the first wall and the second wall being connected to each other to define a receiving space of the capsule, and the interface being disposed at the connection between the first wall and the second wall and communicating with the receiving space.

[0026] In at least some embodiments, the first wall has a first orthographic projection in the plane where the guide channel is located; the second wall has a second orthographic projection in the plane where the guide channel is located; wherein the first orthographic projection and the second orthographic projection completely overlap.

[0027] In at least some embodiments, the first wall has a first orthographic projection in the plane where the guide channel is located; the second wall has a second orthographic projection in the plane where the guide channel is located; wherein the second orthographic projection falls within the first orthographic projection.

[0028] According to a third aspect of this disclosure, a method for manufacturing a balloon system is provided, comprising: connecting the closure structure to a first wall of the balloon; connecting a second wall of the balloon to the first wall to form a balloon wall having the interface, wherein the closure structure is located at the interface of the balloon wall, and one of the first wall and the second wall is provided with a through hole; turning the balloon wall and the closure structure outward from the inside through the through hole; and covering the through hole with a cover to form a closed receiving space in the balloon wall.

[0029] In at least some embodiments, the closure structure includes a guiding component comprising a first end and a second end opposite to each other in a first direction, the second end being fitted with a flexible sleeve; in the step of connecting the second wall of the bladder to the first wall, the first end is located inside the bladder wall, and the second end and the flexible sleeve are located outside the bladder wall; after the step of turning the bladder wall and the closure structure outward from the through hole, the first end is located outside the bladder wall, and the second end and the flexible sleeve are located inside the bladder wall.

[0030] According to a fourth aspect of this disclosure, a method for manufacturing the aforementioned balloon system is provided, comprising: connecting the sealing structure to a second wall of the balloon, wherein a through hole is provided on the first wall; connecting the second wall of the balloon to the first wall to cover the through hole, thereby forming a balloon wall having the interface, wherein the sealing structure is located at the interface of the balloon wall and forms a closed receiving space in the balloon wall.

[0031] In at least some embodiments, the closure structure includes a guiding component comprising a first end and a second end opposite to each other in a first direction, the second end being fitted with a flexible sleeve; in performing the step of connecting the second wall of the bladder to the first wall, the first end is located outside the bladder wall, and the second end and the flexible sleeve are located inside the bladder wall.

[0032] In at least some embodiments, the flexible sleeve includes a chamber communicating with the guide channel, and the flexible sleeve is provided with an opening; the manufacturing method further includes: guiding the guide into the guide channel, and passing it through the chamber and out of the opening to enter the receiving space of the sac.

[0033] The closure structure, balloon system, and manufacturing method of the balloon provided in this disclosure, by positioning the first end of the guiding component and the first opening of the guiding channel on the outer side of the balloon wall (i.e., protruding outwards from the balloon wall), can, on the one hand, disperse the stress generated by pulling out the guiding component, for example, dispersing it onto the balloon wall. This avoids stress concentration on the closure structure and reduces the risk of rupture of the closure structure itself. On the other hand, even if a large pulling force is applied, the closure structure will not be pulled out of the balloon, thereby avoiding the formation of a navel-like protrusion and solving the problem of incomplete closure structure caused by pulling out the catheter. Moreover, the above-described arrangement also reduces the space occupied by the closure structure inside the balloon. Attached Figure Description

[0034] To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings of the embodiments will be briefly described below. Obviously, the drawings described below only relate to some embodiments of this disclosure and are not intended to limit this disclosure.

[0035] FIG. 1A A plan view of the balloon system provided in the embodiment of this disclosure in a filled state;

[0036] FIG. 1B A plan view of the balloon system provided in an embodiment of this disclosure in an unfilled and compressed state;

[0037] FIG. 2 This is a plan view of the internal structure of the balloon system provided in an embodiment of this disclosure.

[0038] FIG. 2A for FIG. 2 A magnified view of a portion of the image;

[0039] FIG. 2B For along FIG. 2 A schematic diagram of the cross-section without a conduit, taken from line AA;

[0040] FIG. 3 This is a schematic internal plan view of the guide component provided in an embodiment of the present disclosure;

[0041] FIG. 4 Another internal plan view of the guide component provided in an embodiment of this disclosure;

[0042] FIG. 5 An exploded view of a closed structure provided in an embodiment of this disclosure;

[0043] FIG. 6 A flowchart illustrating a method for manufacturing a balloon system provided in this embodiment of the disclosure;

[0044] FIG. 7 This is a schematic internal plan view of the balloon system provided in an embodiment of the present disclosure when it is not flipped up;

[0045] FIG. 8 This is a schematic diagram of the internal plan view of the balloon system provided in the embodiments of this disclosure after it has been flipped up;

[0046] FIG. 9 A perspective view of the first and second walls of a balloon system provided in another embodiment of this disclosure when they are not bonded together;

[0047] FIG. 10 for FIG. 9 The first and second walls after bonding along FIG. 9 A bottom view of the BB line;

[0048] FIG. 11 A flowchart illustrating a method for manufacturing a balloon system according to another embodiment of this disclosure;

[0049] FIG. 12This is a perspective view of the first and second walls of a balloon system provided in yet another embodiment of the present disclosure when they are not bonded together. Detailed Implementation

[0050] To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0051] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by one of ordinary skill in the art to which this disclosure pertains. The terms “first,” “second,” and similar terms used in this patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as “comprising” or “including” indicate that the element or object preceding “comprising” or “including” encompasses the element or object listed following “comprising” or “including” and its equivalents, and do not exclude other elements or objects. Terms such as “connected” or “linked” are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Terms such as “upper,” “lower,” “left,” and “right” are used only to indicate relative positional relationships, and these relative positional relationships may change accordingly when the absolute position of the described object changes.

[0052] The inventors noted that when the catheter is removed, the resistance (such as the friction generated during removal) mainly comes from the sealing structure. If the force on the sealing structure is large, part of the sealing structure may be pulled out of the balloon, forming a navel-like protrusion, thus compromising the integrity of the sealing structure. In addition, because the force on the sealing structure is relatively concentrated, it may cause the sealing structure itself to rupture, thereby compromising the seal after the catheter is removed.

[0053] Therefore, this disclosure provides a closure structure for a sac, a balloon system, and a method for manufacturing the same.

[0054] According to an embodiment of this disclosure, a closure structure for a sac is provided, wherein the sac includes a sac wall, the closure structure includes a guiding component that penetrates the sac wall and is connected to the sac wall, the connection point on the sac wall with the guiding component is an interface of the sac, the guiding component has a guiding channel configured to temporarily accommodate a guide, the guiding channel including a first opening located outside the sac wall, and the guiding component including a first end located outside the sac wall and surrounding the first opening.

[0055] In the closure structure of the balloon provided in the above-described embodiments of this disclosure, by positioning the first end of the guiding component and the first opening of the guiding channel on the outer side of the balloon wall (i.e., protruding outwards from the balloon wall), the stress generated by pulling out the guiding component can be dispersed, for example, distributed to the balloon wall. This avoids stress concentration on the closure structure and reduces the risk of rupture of the closure structure itself. On the other hand, even if a large pulling force is applied, the closure structure will not be pulled out of the balloon, thereby avoiding the formation of a navel-like protrusion and solving the problem of incomplete closure structure caused by pulling out the catheter. Moreover, the above-described arrangement also reduces the space occupied by the closure structure inside the balloon.

[0056] The present disclosure will now be described through specific embodiments. To keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and components may be omitted. When any component of an embodiment of the present disclosure appears in more than one drawing, the component may be represented by the same reference numerals in each drawing.

[0057] FIG. 1A A plan view of the balloon system provided in the embodiment of this disclosure in a filled state; FIG. 1B A plan view of the balloon system provided in an embodiment of this disclosure in an unfilled and compressed state; FIG. 2 A plan view of the internal structure of the balloon system provided in this embodiment of the disclosure; FIG. 2A for FIG. 2 A magnified view of a portion of the image; FIG. 2B For along FIG. 2 A schematic diagram of the cross-section without a conduit, taken from line AA.

[0058] like FIG. 1A and FIG. 2 As shown, for example, a balloon system provided according to an embodiment of this disclosure includes: a closed structure 1 and a balloon 2. The balloon 2 includes a balloon wall 4 that defines a containment space V1 for containing a filler such as a gas or a liquid.

[0059] In some embodiments, the balloon system also includes a catheter 3 (i.e., a guide) inserted into the balloon wall 4 through a closure structure 1 to fill the receiving space V1 with filler.

[0060] In some embodiments, the balloon system is configured to have a use state and a non-use state. The non-use state includes, for example, a compressed state and an expanded state. The use state includes, for example, a state when filled with filler material. In the use state, the catheter 3 is configured to enter the inner side S2 of the balloon 2 from the outer side S1 using the closure structure 1, and fill the balloon 2 with filler material. For example, FIG. 1BIn the process, the balloon system is in a compressed state, with balloon 2 folded and stored inside capsule 5. After being swallowed, capsule 5 enters the stomach and dissolves and releases balloon 2 within a specified time. The operator injects filler into balloon 2 through catheter 3, causing balloon 2 to inflate and expand. After the filler has fully inflated, catheter 3 is removed. Upon removal of catheter 3, the sealing structure 1 self-seales, leaving the balloon system in the stomach.

[0061] like FIG. 1A and FIG. 2 As shown, for example, the sac 2 includes a sac wall 4 with a mating interface 4P, and a closing structure 1 penetrates the sac wall 4 through the mating interface 4P, such that a portion of the closing structure 1 is located on the outer side S1 of the sac 2. In this embodiment of the present disclosure, the side of the sac wall 4 facing the inside of the sac is defined as the inner side S2, and the side facing the outside of the sac is defined as the outer side S1.

[0062] like FIG. 2A As shown, for example, the closed structure 1 includes a guide assembly 10 that penetrates and connects to the capsule wall 4 via an interface 4P. The interface 4P is the connection point between the guide assembly 10 and the capsule wall 4. The guide assembly 10 has a guide channel 11 configured to temporarily accommodate the catheter 3. Specifically, the guide channel 11 penetrates the capsule wall 4 and is perpendicular to the tangential plane P of the capsule wall at the interface 4P, which is perpendicular to the X direction. In this embodiment, the term "temporary" means that the catheter 3 is withdrawn from the guide channel 11 after the capsule is filled with filler material and is not permanently placed in the guide channel 11; the term "accommodate" means that a portion of the catheter 3 is placed or inserted within the guide channel 11, rather than being entirely disposed within the internal space of the guide channel 11.

[0063] For example, the guide channel 11 includes a first opening 11A and a second opening 11B that are opposite to each other in its extension direction (e.g., the X direction shown in the figure, also referred to as the first direction), wherein the first opening 11A is located on the outer side S1 of the capsule wall 4 and the second opening 11B is located on the inner side S2 of the capsule wall 4.

[0064] For example, the guide assembly 10 includes a first end 10A and a second end 10B opposite to each other in the X direction, wherein the first end 10A is located on the outer side S1 of the capsule wall 4 and surrounds the first opening 11A, and the second end 10B is located on the inner side S2 of the capsule wall 4 and surrounds the second opening 11B. That is, the first end 10A surrounds the first opening 11A in the circumferential direction of the guide channel 11, and the second end 10B surrounds the second opening 11B in the circumferential direction of the guide channel 11.

[0065] In some cases, to improve the seal between the catheter 3 and the guide channel 11, the guide channel 11 and the catheter 3 are tightly fitted. When the catheter 3 is pulled out, friction is generated between the catheter 3 and the entire guide channel 11. When the friction is large, the pulling force is also large, which may cause deformation of the sealing structure 1. For example, when the sealing structure 1 is completely placed inside the sac wall 4 on the inner side S2, part of the sealing structure 1 may be pulled out of the sac 2, forming an umbilicus-like protrusion, thereby compromising the integrity of the sealing structure 1.

[0066] In this embodiment of the present disclosure, by setting the first end 10A of the guide assembly 10 and the first opening 11A of the guide channel 11 on the outer side S1 of the sac wall 4, the closure structure 1 can be prevented from being pulled out of the sac 2 under a large pull-out force, thereby ensuring the integrity of the closure structure 1 after the catheter 3 is withdrawn.

[0067] Furthermore, when the entire closure structure 1 is located inside the capsule wall 4 (S2), it occupies a large portion of the capsule's internal space and the space within the capsule itself. This results in a balloon that, after folding and storage, is not suitable for implantation into the stomach via the upper digestive tract. In this embodiment, by placing part of the closure structure 1 on the outer side (S1) of the capsule wall 4, the space occupied by the closure structure 1 within the capsule is reduced, freeing up more space for the capsule or reducing its size. This improves the safety of the balloon storage and enhances patient comfort during swallowing.

[0068] For example, the closure structure 1 also includes two side wings 20a and 20b, which are connected to the guide assembly 10 and to a portion of the capsule wall 4 near the interface 4P. The side wings are configured to be parallel to the plane containing the guide channel 11. A portion of each side wing 20a and 20b is located on the outer side S1 of the capsule wall 4 and is connected to the first end 10A.

[0069] Without the side wings 20a and 20b, when the catheter 3 is pulled out, the stress on the sealing structure 1 is relatively concentrated, mainly on the guide component 10 around the catheter 3. Since the guide component 10 is connected to the bladder wall 4 by bonding or welding, tearing or breakage can easily occur at the connection, thereby compromising the sealing performance of the sealing structure 1.

[0070] In this embodiment of the present disclosure, by setting the first opening 11A and the first end 10A surrounding the first opening 11A on the outside of the bladder wall 4, and adding the side wings 20a and 20b connected to the first end 10A, the stress on the guide member 10 can be distributed to the side wings 20a and 20b, preventing the sealing structure 1 from tearing or breaking, thereby ensuring that the sealing structure 1 still has good sealing performance after the catheter is withdrawn.

[0071] In this embodiment, the side wings 20a and 20b can be configured and structured in the same way or differently. When their configuration and structure are the same, the manufacturing process can be simplified, which is therefore preferred. This embodiment is illustrated by taking the side wings 20a and 20b having the same configuration and structure as an example.

[0072] like FIG. 2B As shown, for example, the capsule wall 4 includes a first wall 401 and a second wall 402, which are connected to each other to define a receiving space V1 for the capsule 2. The interface 4P communicates with the receiving space V1. That is, the second wall 402 and the first wall 401 are stacked in the thickness direction of the first wall 401 (e.g., the Z direction shown in the figure), and the guide member 10 is located between the first wall 401 and the second wall 402, wherein the Z direction is perpendicular to the plane containing the side wings 20a and 20b (e.g., the XY plane shown in the figure). In one embodiment, the first wall 401 and the second wall 402 are integrally formed.

[0073] Compared to the one-piece balloon wall 4, in this embodiment of the disclosure, by setting the balloon wall 4 to have a first wall 401 and a second wall 402, it is advantageous to install and fix the guide component 10 and the side wings 20a, 20b on the first wall 401 or the second wall 402 during the manufacturing process of the balloon system, thereby simplifying the manufacturing process.

[0074] In some embodiments, the guiding component 10 includes a first flexible layer 101 and a second flexible layer 102, the second flexible layer 102 being stacked on top of the first flexible layer 101 in the Z direction and partially connected to each other to define a guiding channel 11 located between the first flexible layer 101 and the second flexible layer 102. For example, FIG. 3 The shaded area in the image represents the connection area between the first flexible layer 101 and the second flexible layer 102.

[0075] For example, the second flexible layer 102 is located above the first flexible layer 101 and both are located between the first wall 401 and the second wall 102. The first flexible layer 101 is in contact with the first wall 401 and connected to each other, and the second flexible layer 102 is in contact with the second wall 402 and connected to each other.

[0076] In some embodiments, at least one of the first flexible layer 101 and the second flexible layer 102 is connected to the side wings 20a and 20b. That is, the side wings 20a and 20b can be connected to the first flexible layer 101, the second flexible layer 102, or both. When the conduit 3 is pulled out, this arrangement helps to distribute the force borne by the first flexible layer 101 and the second flexible layer 102 to the side wings 20a and 20b.

[0077] In some embodiments, one of the flexible layers 101 and 102 is connected to the side wings 20a, 20b. For example, as... FIG. 2B As shown, the first flexible layer 101 is connected to the side wings 20a and 20b. Furthermore, the first flexible layer 101 and the side wings 20a and 20b are made of the same material and are an integral structure.

[0078] When the first flexible layer 101 and the side wings 20a and 20b are formed into an integral structure using the same material, the strength of the connection between the first flexible layer 101 and the side wings 20a and 20b can be enhanced, thereby avoiding breakage caused by weak connection.

[0079] In some embodiments, the material used to fabricate the first flexible layer 101 and the side wings 20a, 20b is an elastic material composed of silicon oxide monomers, such as silicone. In one example, the first flexible layer 101 is a thin film made of silicone, which, due to its self-adhesive properties, facilitates sealing. The material of the second flexible layer 102 can be the same as that of the first flexible layer 101. The surfaces of the first and second flexible layers that come into contact with each other are not surface-treated, thus preserving their self-adhesive properties and facilitating sealing.

[0080] For example, such as FIG. 2B As shown, a portion of each of the side wings 20a and 20b is inserted between the first wall 401 and the second wall 402 near the interface 4P and is connected to the first wall 401 and the second wall 402 respectively. Through this arrangement, the stress dispersed by the side wings 20a and 20b can be further dispersed to the first wall 401 and the second wall 402, thereby avoiding stress concentration on the side wings 20a and 20b, and thus ensuring the integrity of the guide assembly 10 after the conduit is removed.

[0081] In some embodiments, such as FIG. 2 and FIG. 2A As shown, the periphery 401E of the first wall 401 and the periphery (not shown) of the second wall 402 portion are connected to each other to form a joint area 410, and the partial wings 20a and 20b connected to the first wall 401 and the second wall 402 are located in the joint area 410.

[0082] In the fabrication of the balloon system, the first wall 401 and the second wall 402 are connected to each other in the seam area 410, for example, by adhesive bonding. By placing some of the side wings 20a and 20b in the seam area 410, the side wings 20a and 20b can be fixed between the first wall 401 and the second wall 402 while the first wall 401 and the second wall 402 are being bonded together, thereby enhancing the strength of the side wings 20a and 20b and reducing the risk of the side wings being torn.

[0083] For example, interface 4P is located in the joint area 410.

[0084] The following section uses wing 20a as an example to further explain the configuration and structure of the wing.

[0085] like FIG. 2A As shown, for example, the flank 20a includes a first portion 211 located on the outer side S1 of the capsule wall 4 and a second portion 212 located on the inner side S2 of the capsule wall 4, the second portion 212 being connected to the first portion 211. That is, the orthographic projection of the first portion 211 in the XY plane falls on the outer side S1 of the capsule wall 4, and the orthographic projection of the second portion 212 in the XY plane falls on the inner side S2 of the capsule wall 4.

[0086] For example, the first part 211 is connected to the first end 10A of the guide assembly 10, and the second part 212 is connected to the second end 10B of the guide assembly 10. That is, the first part 211 and the first end 10A are both located on the outer side S1 of the capsule wall 4 and are connected to each other, while the second part 212 and the second end 10B are both located on the inner side S2 of the capsule wall 4 and are connected to each other.

[0087] In this embodiment of the present disclosure, by connecting the first portion 211 of the side wing 20a to the first end 10A of the guide assembly 10, the stress borne on the first end 10A is distributed to the first portion 211; by connecting the second portion 212 to the second end 10B of the guide assembly 10, the stress borne on the second end 10B is distributed to the second portion 212. This further reduces the stress borne on the guide assembly 10.

[0088] FIG. 3 This is a schematic internal plan view of the guide component provided in an embodiment of this disclosure. FIG. 4 Another internal plan view of the guiding component provided in an embodiment of this disclosure.

[0089] For example, combining FIG. 2 and FIG. 3 The guide channel 11 penetrates the capsule wall 4 and extends in the X direction. The guide channel 11 includes a first channel portion 111 and a second channel portion 112 that are connected in the X direction. The first channel portion 111 is located outside the capsule wall 4 S1 and defines a first opening 11A. The second channel portion 112 is located inside the capsule wall 4 S2 and defines a second opening 11B.

[0090] In this paper, the term "channel" refers to a path that allows the conduit 3 to pass through. In its natural state, this channel is not necessarily open, i.e., it does not necessarily have a three-dimensional accommodating space. For example, as... FIG. 2B As shown, although a guide channel 11 exists between the first flexible layer 101 and the second flexible layer 102, the channel is in a closed state, so it is impossible to guide the flow from the first flexible layer 101 to the second flexible layer 102. FIG. 2BThis is evident from the fact that the first flexible layer 101 and the second flexible layer 102, made of silicone, have self-adhesive properties in their natural state. When the conduit 3 is inserted, as long as a certain pushing force is applied, the guide channel 11 can be opened and pushed into it using the conduit 3.

[0091] In some embodiments, such as FIG. 2A As shown, the width of at least one of the first channel portion 111 and the second channel portion 112 increases along the X direction and toward the direction away from the bladder wall 4, wherein the width is the dimension of the channel portion in the Y direction (also called the second direction) parallel to the XY plane, and the Y direction is perpendicular to the X direction.

[0092] For example, such as FIG. 4 and FIG. 5 As shown, the width of each of the first channel portion 111 and the second channel portion 112 increases along the X direction and in a direction away from the capsule wall 4. For example, the width of the first channel portion 111 is a first width g1, and the width of the second channel portion 112 is a second width g2, both of which gradually increase in the direction away from the capsule wall 4. That is, the first channel portion 111 and the second channel portion 112 have a funnel shape.

[0093] In some cases, when the first channel portion 111 and the second channel portion 112 are not funnel-shaped, but rather straight, the balloon, during long-term storage, may remain deformed due to the presence of the catheter 3. After the balloon is inflated and the catheter is removed, the guiding channel cannot be completely sealed. During catheter removal, the sealing structure may still be pulled outwards from the guiding channel under significant force, thus failing.

[0094] In this embodiment of the present disclosure, by setting both the first channel portion 111 and the second channel portion 112 to a funnel shape, not only can the resistance generated by inserting or pulling out the catheter 3 be reduced, but also the permanent deformation of the guide component 11 can be avoided, reducing the risk of leakage. Furthermore, it can effectively prevent the catheter from pulling out the closed structure 1 when it is pulled out, avoiding the formation of a "navel" or "tail", thus ensuring the integrity of the closed structure.

[0095] For example, such as FIG. 3 As shown, the guide channel 11 also includes a third channel portion 113 connecting the first channel portion 111 and the second channel portion 112. The third channel portion 113 has a third width g3 in the Y direction, and the third width g3 is a constant value in the X direction. For example, the first channel portion 111 and the second channel portion 112 may be symmetrically arranged with respect to the third channel portion 113.

[0096] In this embodiment of the invention, by symmetrically arranging the first channel portion 111 and the second channel portion 112 relative to the third channel portion 113, the complexity of the guide channel 11 in design and manufacturing can be reduced, and the manufacturing process can be simplified. It is understood that the first channel portion 111 and the second channel portion 112 can also be asymmetrically arranged. For example, in other embodiments of the invention, the first channel portion 111 has a flared shape, while the second channel portion 112 does not, and the objective of the invention can still be achieved.

[0097] For example, such as FIG. 2A As shown, the orthographic projection of the third channel portion 113 in the XY plane and the orthographic projection of the interface in the XY plane at least partially overlap.

[0098] Since the width of the third channel portion 113 is a constant value, the compressive or tensile force borne by the third channel portion 113 is relatively large when the conduit 3 is inserted or removed. By setting the orthographic projection of the third channel portion 113 in the XY plane and the orthographic projection of the interface in the XY plane to at least partially overlap, it is beneficial for the third channel portion 113 to quickly transmit the stress it bears to the first wall 401 and the second wall 402 at the interface through the side wings 20a and 20b, thereby avoiding cracking or breakage near the third channel portion 113 due to stress concentration.

[0099] For example, combining FIG. 2A and FIG. 3 The guide channel 11 also includes a boundary line BL located at the junction of the third channel portion 113 and the first channel portion 111. The orthographic projection of the seam area 410 on the XY plane falls on the side of the orthographic projection of the boundary line BL on the XY plane closer to the second channel portion 112. Furthermore, the orthographic projection of the interface 4P on the XY plane falls on the side of the orthographic projection of the boundary line BL on the XY plane closer to the second channel portion 112.

[0100] Experiments have shown that the most likely place for breakage when inserting or removing the conduit 3 is at the point of abrupt change in material thickness. Taking the first channel portion 111 and the third channel portion 113 as examples, breakage is more likely to occur near the junction line BL. In this embodiment of the present disclosure, by making the orthographic projection of the joint area 410 (e.g., the interface 4P) fall inside the orthographic projection of the junction line BL, it is more beneficial to disperse the stress concentrated at the junction line BL to the joint area 410, thereby reducing the risk of breakage.

[0101] In this embodiment of the disclosure, such as FIG. 4 As shown, the dimensions of the first channel portion 111, the second channel portion 112, and the third channel portion 113 in the X direction are c1, c2, and c3, respectively. The maximum dimension of the guide channel 11 in the X direction is a, and c2 satisfies the following condition:

[0102]

[0103] If c2 is too large, it can cause the following problems: 1) It can lead to c1 and c2 on both sides being too small, failing to function as a funnel (c2 helps reduce deformation of the second channel section during long-term shelf life, c1 helps insert the catheter, and c1 and c2 work together to improve stress distribution); 2) It can increase the pull-out force of catheter 3, which is unsafe for the balloon and the sealing structure, and also unfriendly to the patient. If c2 is too small, it can cause the following problems: 1) It can increase the probability of leakage in the guiding channel during the filling phase; 2) Insufficient pull-out force increases the risk of accidental balloon dislodgement.

[0104] In this embodiment, assuming the cross-section of the conduit 3 is circular with an outer diameter of s, the outer circumference is π*s. The third width g3 of the third channel portion 113 and the outer circumference π*s satisfy the following relationship: g3 ≤ 1 / 2*π*s. With the above arrangement, the first flexible layer 101 and the second flexible layer 102 made of silicone can tightly wrap around the conduit 3, thereby improving the sealing performance and preventing the filler from overflowing from the gap between them.

[0105] In this embodiment of the present disclosure, the maximum value of the first width g1 (g1max), the maximum value of the second width g2 (g2max), and the outer circumference π*s of the conduit 3 satisfy the following relationship: g1max ≥ 1 / 2*π*s and g2max ≥ 1 / 2*π*s, preferably, g1max = g2max. This setting reduces the stress generated by the conduit 3 during insertion or removal.

[0106] like FIG. 3 As shown, for example, the wing 20a includes a first end 201 and a second end 202 opposite to each other in the Y direction. The first end 201 is close to and connected to the guide assembly 10, and the second end 202 is away from the guide assembly 10. A portion of the first end 201 is located outside the capsule wall 4. Since the wing 20a is connected to the first end 10A of the guide assembly 10, by placing a portion of the first end 201 outside the capsule wall 4, it is more beneficial for the stress borne on the first end 10A to be quickly dispersed to the capsule wall 4 through the portion of the first end 201, thereby preventing the guide assembly 10 from rupturing and ensuring the integrity of the closure structure after the catheter is withdrawn.

[0107] For example, the wing 20a also includes a connecting portion 203 connecting the first end 201 and the second end 202. The connecting portion 203 includes a first outer edge 2031 and a second outer edge 2032 that are opposite to each other in the X direction. The first outer edge 2031 is located on the outer side S1 of the capsule wall 4, and the second outer edge 2032 is located on the inner side S2 of the capsule wall 4.

[0108] For example, at least one of the first outer edge 2031 and the second outer edge 2032 is non-linear. For example, both the first outer edge 2031 and the second outer edge 2032 are non-linear. Compared to both the first outer edge 2031 and the second outer edge 2032 being linear, non-linearity is advantageous for saving material and shape transition.

[0109] It is understood that in the embodiments of this disclosure, the first outer edge 2031 and the second outer edge 2032 may also be straight, and the embodiments of this disclosure do not limit this.

[0110] For example, the non-linear shape is an arc, with the first outer edge 2031 having a first arc and the second outer edge 2032 having a second arc. In this embodiment of the disclosure, the curvature of the first arc and the curvature of the second arc can be equal or unequal.

[0111] Depending on whether the catheter 3 is inserted or removed, the tensile deformation experienced by the first outer edge 2031 and the second outer edge 2032 will be slightly different. For example, when the catheter 3 is removed, the tensile deformation experienced by the first outer edge 2031 is greater. In this case, by setting the curvature of the first arc to be greater than that of the second arc, it is possible to further prevent the first outer edge 2031 from cracking or tearing, thereby ensuring the integrity of the sealing structure after the catheter is removed.

[0112] In some embodiments, such as FIG. 3 As shown, in the Y direction and in the direction away from the guide assembly 10, the dimensions of the side wings 20a and 20b in the X direction are reduced.

[0113] For example, such as FIG. 4 As shown, the dimension of the first end 201 in the X direction is the maximum dimension of the side wings 20a and 20b in the X direction, and the dimension of the second end 202 in the X direction is the minimum dimension of the side wings 20a and 20b in the X direction; in the Y direction and in the direction away from the guide assembly 10, the side wings 20a and 20b decrease from the maximum dimension to the minimum dimension. Furthermore, in the Y direction and in the direction away from the guide assembly 10, the side wings 20a and 20b gradually decrease from the maximum dimension to the minimum dimension.

[0114] Compared to the fact that the dimensions of the lateral wings 20a and 20b in the X direction are constant and that constant value is the maximum size, by gradually reducing the dimensions of the lateral wings 20a and 20b from the maximum size to the minimum size, the material used for the lateral wings can be reduced while distributing stress to the bladder wall, thus avoiding occupying more space in the patient's gastrointestinal tract.

[0115] For example, such as FIG. 4As shown, the vertical distance d between the first end 201 and the second end 202 of the side wing 20a in the Y direction is d. Similarly, the vertical distance d between the first end and the second end of the side wing 20b in the Y direction is d. The vertical distance d satisfies the following condition:

[0116]

[0117] Where a is the dimension of the guide channel 11 in the X direction, and e is the dimension of the guide assembly 10 in the Y direction. d should not be too large or too small, otherwise it will affect the forming and connection process of the first and second walls. In some embodiments, d is approximately equal to e. In this document, the term "approximately" can be understood as not strictly requiring numerical limits, allowing values ​​within the range of process and measurement errors.

[0118] For example, such as FIG. 3 As shown, the two side wings 20a and 20b are symmetrically arranged with respect to the center line OO of the guide assembly 10 along the X direction. If the two side wings 20a and 20b are not symmetrically arranged, the stress distributed on the upper and lower sides of the capsule wall of the guide assembly 10 will be different, resulting in uneven stress on the capsule wall, which in turn causes different local deformations of the capsule wall and makes the capsule wall more prone to rupture.

[0119] In this embodiment of the disclosure, by symmetrically arranging the two side wings 20a and 20b, not only is the force on the capsule wall more uniform, but it is also easier to manufacture and process the guiding components.

[0120] For example, such as FIG. 3 As shown, the first flexible layer 101 includes a first side S11 and a second side S12 opposite to each other in the Y direction. Two side wings 20a and 20b are located on the first side S11 and the second side S12, respectively, and are connected to the first flexible layer 101 on the first side S11 and the second side S12, or are respectively extensions of the first flexible layer 101. Through the above arrangement, the stress borne by the first flexible layer 101 and the second flexible layer 102 can be quickly dispersed to the two side wings 20a and 20b, thereby reducing the tensile deformation of the closure structure when the catheter is pulled out, thus ensuring the integrity of the closure structure.

[0121] It should be noted that this embodiment of the invention uses a closed structure comprising two side wings 20a and 20b as an example for illustration. However, the number of side wings is not limited to two; it can be one or more, and the purpose of the invention can be achieved in the same way. In some embodiments, the closed structure includes one side wing 20a connected to the first flexible layer 101. In other embodiments, the closed structure includes not only the two side wings 20a and 20b connected to the first flexible layer 101, but also two additional side wings connected to the second flexible layer 102. Therefore, this embodiment of the invention does not limit the number of side wings.

[0122] FIG. 5An exploded view of a closed structure provided in an embodiment of this disclosure. For example, as... FIG. 5 As shown, the second flexible layer 102 is located above the first flexible layer 101. The two are stacked in the Z direction and partially connected to each other to form a guide channel for accommodating the conduit 3.

[0123] For example, combining FIG. 2 , FIG. 2A and FIG. 5 The closed structure 1 may further include a flexible sleeve 30 sleeved on and connected to the second end 10B. The flexible sleeve 30 includes a chamber V2 communicating with the second opening 11B. The chamber V2 is configured to temporarily accommodate the catheter 3. When the catheter 3 is inserted, the catheter 3 can extend into the chamber V2 through the second opening 11B.

[0124] As described above, the untreated silicone film has strong self-adhesive properties. Normally, when the catheter is removed, the two silicone films (i.e., the first flexible layer 101 and the second flexible layer 102) adhere tightly together, thereby closing the guide channel to achieve self-sealing or self-closing. However, in some cases, the two silicone films may not adhere tightly enough, and they cannot form a perfect closure.

[0125] In this embodiment, by additionally sleeved with a flexible sleeve 30 on the second end 10B of the guide component 10, leakage of the filler can be further prevented after the catheter is pulled out, even if the upper and lower silicone films are not tightly adhered, thus improving the sealing performance. In other words, by employing a combination design of the guide component and the flexible bag, a double seal is achieved. This design is not only simple but also occupies less volume and saves space inside the capsule.

[0126] For example, such as FIG. 5 As shown, a portion of the second end 10B is located within the chamber V2, and the dimension of this portion of the second end 10B in the Y direction is smaller than the dimension of the chamber V2 in the Y direction. This allows the flexible sleeve 30 to be tightly connected along the circumferential direction of the second end 10B, further improving the sealing effect.

[0127] For example, the dimension of the second end 10B in the Y direction gradually decreases in the X direction and in the direction away from the first end 10A, which is beneficial for achieving a tight fit with the flexible sleeve 30.

[0128] For example, such as FIG. 5 As shown, the flexible sleeve 30 includes a third flexible layer 31 and a fourth flexible layer 32, which are stacked in the Z direction and partially connected to each other to define a chamber V2. For example, the third flexible layer 31 and the fourth flexible layer 32 can be connected together by adhesive or welding.

[0129] For example, one of the third flexible layer 31 and the fourth flexible layer 32 is provided with an opening 33, which is configured to allow the catheter 3 located in the cavity to pass through it and enter the bladder 2. That is, the catheter 3 passes through the guide channel 11, passes through the flexible sleeve 30, and exits through the opening 33 into the interior of the bladder. Therefore, by providing the opening 33, it can be ensured that the filler does not leak when it is full.

[0130] In some embodiments, the diameter of the opening 33 is less than or equal to the outer diameter of the conduit 3, thereby achieving a tight fit between the two and reducing the risk of backflow of the filler.

[0131] In this embodiment of the disclosure, the third flexible layer 31 and the fourth flexible layer 32 may be made of the same material as the first flexible layer 101 and the second flexible layer 102. For specific materials, please refer to the previous description, which will not be repeated here.

[0132] For example, such as FIG. 3 As shown, the first flexible layer 101 may also include a protrusion 10C connected to the first end 10A. The outer edge of the protrusion 10C is, for example, arc-shaped, which facilitates the operator to quickly insert the catheter 3 into the guide channel 11.

[0133] In this embodiment, assuming the maximum dimension of the closed structure 1 in the X direction is f, and the maximum dimension of the guide channel 11 in the X direction is a, then the two satisfy the following relationship: a / f ≥ 2 / 3. Through the above setting, the length of f is minimized while ensuring sufficient channel length, thus saving space occupied by the flexible sleeve. If the above ratio is too small, it is difficult to manufacture the flexible sleeve due to limitations in the connection process. In some embodiments, for example, a / f ≈ 2 / 3.

[0134] In this embodiment of the disclosure, the connection between the various components can be by adhesive bonding or welding, and this embodiment of the disclosure is not limited in this respect. For example, the guide component 10 and the bladder 2 can be connected together by adhesive bonding or welding. The first wall 401 and the second wall 402 can be connected together by adhesive bonding or welding to form the bladder 2. The second flexible layer 102 and the first flexible layer 101 are connected together by adhesive bonding or welding to form the guide component 10. The edges of the fourth flexible layer 32 and the third flexible layer 31 can be connected together by adhesive bonding or welding to form the flexible sleeve 30. The guide component 10 and the flexible sleeve 30 can be connected together by adhesive bonding or welding.

[0135] In this embodiment, the sealing structure is an independent module, which can greatly reduce the manufacturing difficulty of the balloon system and improve production efficiency. Under the same conditions, the sealing structure as an independent module can reduce the defect rate in balloon production and reduce the consumption of raw materials and labor time caused by the defective sealing structure.

[0136] To test the airtightness of the sealed structure, the inventors injected physiological saline into the balloon and immersed it in an isotonic liquid environment, testing the mass of the water balloon every 3 months. The experimental results are shown in Table 1.

[0137] Table 1

[0138]

[0139]

[0140] As shown in Table 1, the average mass change rate of the balloon made using the closed structure provided in this embodiment, after immersion in an isotonic fluid environment for 6 months, was less than 0.02%, demonstrating the good sealing performance of the closed structure. Furthermore, in known technologies, the pull-out force of catheter 3 is approximately 3-5 Newtons. However, in this application, using the same catheter diameter and channel width (the width of the middle portion of the channel is the same), the catheter pull-out force is reduced by 0.5-1 Newton. This ensures the integrity of the closed structure while reducing discomfort to the patient's upper gastrointestinal tract caused by excessive pull-out force.

[0141] According to embodiments of this disclosure, a method for manufacturing a balloon system is also provided. In some embodiments, the manufacturing method provided according to embodiments of this disclosure can be used to manufacture the balloon system described in the preceding embodiments. Since the balloon system includes the closed structure described in the preceding embodiments, the manufacturing method also has the technical effects described in the preceding embodiments, which will not be repeated here.

[0142] FIG. 6 A method for manufacturing a balloon system provided in this disclosure embodiment; FIG. 7 This is a schematic internal plan view of the balloon system provided in an embodiment of the present disclosure when it is not flipped up; FIG. 8 This is a schematic diagram of the internal plan of the balloon system provided in an embodiment of this disclosure after it has been flipped up.

[0143] For example, such as FIG. 6 to FIG. 8 As shown, the method for manufacturing according to embodiments of this disclosure is provided. FIG. 1A to FIG. 5 The method for manufacturing the balloon system shown includes:

[0144] S100: Connect the closed structure 1 to the first wall 401 of the bladder 2;

[0145] S200: The second wall 402 of the capsule 2 is connected to the first wall 401 to form a capsule wall 4 with a mating interface 4P, wherein the closing structure 1 is located at the mating interface 4P, and one of the first wall 401 and the second wall 402 is provided with a through hole 403, such as FIG. 7 As shown;

[0146] S300: The capsule wall 4 and the sealing structure 1 are turned outwards from the inside through the through hole 403; and

[0147] S400: The cover 404 covers the through hole 403 to form a closed receiving space V1 in the bladder wall 4, such as FIG. 8 As shown.

[0148] Without the cyst wall 4 everted from the inside out, the first wall 401 and the second wall 402 adhere to each other to form a seam. At this time, the seam is on the outside of the cyst, which can easily cause friction or damage to the stomach wall.

[0149] In this embodiment of the present disclosure, by turning the bladder wall 4 and the sealing structure 1 out together from the through hole 403, the first wall 401 and the second wall 402 are kept smooth at the joint surface, thereby reducing friction or damage to the stomach wall.

[0150] In the above manufacturing method, the through hole 403 is used to allow the capsule wall and the sealing structure to be turned outwards, and then closed with a cover to form a receiving space.

[0151] For example, such as FIG. 1A to FIG. 5 As shown, the closed structure 1 includes a guide assembly 10, which includes a first end 10A and a second end 10B opposite to each other in the X direction. A flexible sleeve 30 is fitted onto the second end 10B. FIG. 7 As shown, in step S200, which connects the second wall 402 of the capsule 2 to the first wall 401, the first end 10A is located inside the capsule wall 4 (S2), and the second end 10B and the flexible sleeve 30 are located outside the capsule wall 4 (S1); FIG. 8 As shown, after step 300, in which the capsule wall 4 and the sealing structure 1 are turned outward from the inside through the through hole 403, the first end 10A is located on the outer side S1 of the capsule wall 4, and the second end 10B and the flexible sleeve 30 are located on the inner side S2 of the capsule wall 4. That is, after the step of turning outward from the inside, the first end 10A located inside the capsule is turned outward, and the second end 10B and the flexible sleeve 30 located outside the capsule are turned inward.

[0152] In this embodiment, by flipping the balloon wall 4 and the sealing structure 1 together out of the through hole 403, and positioning the first end 10A on the outside of the balloon wall, the stress generated by the pull-out guide can be dispersed, for example, onto the balloon wall. This avoids stress concentration on the sealing structure and reduces the risk of the sealing structure rupture. Furthermore, even with a large pull-out force, the sealing structure will not be pulled out of the balloon, thus preventing the formation of a navel-like protrusion and solving the problem of incomplete sealing structure caused by the pull-out catheter. Moreover, the above arrangement also reduces the space occupied by the sealing structure inside the balloon.

[0153] For example, such as FIG. 1A to FIG. 5As shown, the closure structure 1 includes side wings 20a and 20b, and the guide assembly 10 has a guide channel 11 configured to temporarily accommodate the catheter 3. The guide channel 11 includes a first opening 11A located on the outer side S1 of the capsule wall 4, and a first end 10A located on the outer side S1 of the capsule wall 4 and surrounding the first opening 11A. The side wings 20a and 20b are connected to the guide assembly 10 and to a portion of the capsule wall 4 surrounding the interface 4P. A portion of the side wings 20a and 20b is located on the outer side S1 of the capsule wall 4 and connected to the first end 10A.

[0154] In this embodiment of the present disclosure, on the one hand, by providing side wings 20a and 20b and connecting the side wings 20a and 20b to the portion of the capsule wall 4 surrounding the interface 4P, the stress generated by pulling out the catheter 3 can be further dispersed, for example, dispersed to the capsule wall 4, thereby further reducing the risk of the sealing structure 1 itself rupturing.

[0155] For example, such as FIG. 1A to FIG. 5 As shown, in the Z direction of the first wall 401 and the second wall 402, the guide assembly 10 and the side wings 20a and 20b are located between the first wall 401 and the second wall 402.

[0156] In this case, in step 100, connecting the closure structure 1 to the first wall 401 of the bladder 2 includes connecting the guide assembly 10 and the side wings 20a, 20b to the periphery of the first wall 401 located at the interface 4P.

[0157] For example, such as FIG. 1A to FIG. 5 As shown, in step 200, connecting the closed structure 1 to the second wall 402 of the bladder 2 includes connecting the guide assembly 10 and the side wings 20a, 20b to the periphery of the second wall 402 located at the interface 4P.

[0158] Through the above steps S100 and S200, the stress dispersed by the side wings 20a and 20b can be further dispersed to the first wall 401 and the second wall 402, thereby avoiding stress concentration on the side wings 20a and 20b, and thus ensuring the integrity of the closed structure 1 after the conduit 3 is removed.

[0159] For example, such as FIG. 1A to FIG. 5 As shown, the guide channel 11 also includes a second opening 11B located on the inner side S2 of the capsule wall 4; the guide assembly 10 also includes a second end 10B located on the inner side S2 of the capsule wall 4 and surrounding the second opening 11B; the closing structure 1 also includes a flexible sleeve 30 sleeved on and connected to the second end 10B, the flexible sleeve 30 including a chamber V2 communicating with the second opening 11B (i.e. communicating with the guide channel 11), and the flexible sleeve 30 is provided with an opening 33.

[0160] In this case, the above manufacturing method further includes:

[0161] S500: Guide the catheter 3 into the guide channel 11 and through the chamber V2 out of the opening 33 to enter the receiving space V1 of the balloon 2.

[0162] By additionally sleeved with a flexible sleeve 30 on the second end 10B of the guide component 10, leakage of the filler can be further prevented after the catheter is pulled out, even if the upper and lower silicone films are not tightly adhered, thus improving the sealing performance. In other words, by adopting a combination design of the guide component and the flexible bag, a double seal is achieved, which is not only simple in design but also occupies less volume and saves space inside the capsule.

[0163] Negative pressure is drawn into balloon 2 through catheter 3 and the balloon is vented. After the balloon is vented, it is folded and stored in capsule 5. At this point, the swallowable balloon system is complete.

[0164] After being swallowed, capsule 5 enters the stomach and dissolves within a specified time, releasing capsule 2. The operator then injects filler into capsule 2 through catheter 3. The central channel of guide component 10 and the opening 33 of flexible sleeve tightly enclose catheter 3, preventing leakage of filler throughout the filling process. After filling is complete, catheter 3 is removed. Upon removal, the distal end (i.e., the second port) of guide component 10 closes, and flexible sleeve 30 further tightens the closure of guide component 10, enhancing the seal.

[0165] In this embodiment, the capsule wall 4 is formed by combining two pieces, a first wall 401 and a second wall 402. It is understood that the dimensions of the first wall and the second wall may be the same or different.

[0166] In some embodiments, the dimensions, such as the area, of the first wall and the second wall are the same. Further, as... FIG. 7 and FIG. 8 As shown, the first wall 401 has a first orthographic projection in the XY plane, and the second wall 402 has a second orthographic projection (not shown) in the XY plane. The first and second orthographic projections completely overlap.

[0167] In other embodiments, the dimensions, such as the area, of the first wall and the second wall are different from each other.

[0168] FIG. 9 This is a perspective view of the first and second walls of a balloon system provided in another embodiment of the present disclosure when they are not bonded together. FIG. 10 for FIG. 9 The first and second walls after bonding along FIG. 9 A bottom view of the BB line. (Example) FIG. 9 and FIG. 10As shown, the first wall 401' has a first orthographic projection in the XY plane, and the second wall 402' has a second orthographic projection in the XY plane, the second orthographic projection falling within the first orthographic projection.

[0169] Compared to FIG. 7 , FIG. 8 The sac wall, FIG. 9 The capsule wall does not require the step of turning it from the inside out, thereby reducing the number of steps in the manufacturing process and lowering the difficulty of the manufacturing process.

[0170] According to embodiments of this disclosure, a method for manufacturing a balloon system is also provided. The manufacturing method provided according to embodiments of this disclosure can be used to manufacture… FIG. 9 and FIG. 10 The balloon system described herein includes the closed structure described in the previous embodiments, and therefore the manufacturing method also has the technical effects described in the previous embodiments, which will not be repeated here.

[0171] FIG. 11 A flowchart illustrating a method for manufacturing a balloon system according to another embodiment of this disclosure.

[0172] For example, such as FIG. 9 to FIG. 11 As shown, a method for manufacturing a balloon system according to an embodiment of this disclosure includes:

[0173] S100': Connect the closed structure 1 to the second wall 401' of the bladder 2. The first wall 401' of the bladder 2 is provided with a through hole 403'.

[0174] S200': The second wall 402' of the capsule 2 is connected to the first wall 401' to cover the through hole 403', thereby forming a capsule wall 4 with a mating interface 4P, wherein the closing structure 1 is located at the mating interface 4P of the capsule wall 4, and a closed receiving space V1 is formed in the capsule wall 4.

[0175] Compared to FIG. 6 The manufacturing method in FIG. 11 The manufacturing method reduces the steps of turning the product outwards and covering the through-hole with a cover, which not only reduces the number of steps in the manufacturing process but also lowers the difficulty of the manufacturing process, making it more conducive to industrial production.

[0176] In the above manufacturing method, the through hole 403' is not for flipping the capsule wall, but for facilitating the fabrication of the closed structure 1 between the first wall 401' and the second wall 402'.

[0177] like FIG. 10As shown, the first wall 401' and the second wall 402' are connected to each other to form a joint area 410', and the interface 4P is located in the joint area 410'. The joint area 410' has a third orthographic projection in the XY plane, which falls within the first orthographic projection of the first wall 401' in the XY plane.

[0178] Compared to FIG. 7 When the orthographic projection of the joint area 410 is outside the orthographic projection of the first wall 401, the area of ​​the joint area 410' is significantly reduced. Generally, the larger the area of ​​the joint area (or the longer it can be understood), the more likely leakage will occur at the joint.

[0179] In this embodiment, by ensuring that the orthographic projection of the seam area 410' falls within the orthographic projection of the first wall 401', leakage is avoided, thereby improving the overall sealing performance of the balloon system.

[0180] For example, such as FIG. 10 As shown, the closed structure 1 includes a guide assembly 10, which includes a first end 10A and a second end 10B opposite to each other in the X direction. A flexible sleeve 30 is fitted onto the second end 10B. In step 200', which connects the second wall 402' of the capsule 2 to the first wall 401', the first end 10A is located on the outer side S1 of the capsule wall 4, and the second end 10B and the flexible sleeve 30 are located on the inner side S2 of the capsule wall 4.

[0181] For example, such as FIG. 10 As shown, the flexible sleeve 30 includes a chamber V2 communicating with the guide channel 11 of the guide assembly 10, and the flexible sleeve 30 is provided with an opening 33; in this case, the above manufacturing method further includes:

[0182] S300': Guide the catheter 3 into the guide channel 11, and through the chamber V2 out of the opening 33 to enter the receiving space V1 of the balloon 2.

[0183] By additionally sleeved with a flexible sleeve 30 on the second end 10B of the guide assembly 10, leakage of the filler can be further prevented after the catheter 3 is pulled out, thereby improving the sealing performance and achieving a double seal. This design is not only simple but also occupies less volume and saves space inside the capsule.

[0184] In this embodiment, the specific structure and configuration of the encapsulation structure 1 can be referred to the description in the previous embodiment, and will not be repeated here.

[0185] FIG. 12 This is a perspective view of the first and second walls of a balloon system provided in yet another embodiment of the present disclosure when they are not bonded together.

[0186] FIG. 12 and FIG. 9The difference lies in that the capsule wall is formed by connecting a first wall 401” and a second wall 402”, wherein the first wall 401” includes a first sub-wall 4011 and a second sub-wall 4012 connected to each other, wherein the second sub-wall 4012 is provided with a through hole 403”. The second wall 402” and FIG. 9 The second wall 402' is set in the same way, so it will not be repeated here.

[0187] For example, before step S100', FIG. 11 The manufacturing method of the balloon system may also include:

[0188] S101: Connect the first sub-wall 4011 and the second sub-wall 4012 to each other;

[0189] S102: The first sub-wall 4011 and the second sub-wall 4012 are turned out through the through hole 403” provided on the first sub-wall 4011 to form the first wall 401.

[0190] In this embodiment of the disclosure, by utilizing the first sub-wall 4011 and the second sub-wall 4012 to form the first wall 401", the design scheme is more flexible when manufacturing the first wall of the balloon to meet or adapt to different production conditions.

[0191] In this embodiment, the specific structure and configuration of the encapsulation structure 1 can be referred to the description in the previous embodiment, and will not be repeated here.

[0192] In summary, in the closed structure of the balloon, the balloon system, and the manufacturing method thereof provided in the above embodiments of the present invention, the guide channel of the guide component is designed with a double-flared structure. This ensures that during long-term storage and shelf life, the inner second channel portion will not undergo severe permanent deformation due to the presence of the catheter. Even after the catheter is removed, the channel can still close tightly, preventing leakage problems. Furthermore, the double-flared design distributes the force on the guide component during catheter removal to the seam between the two flexible layers, which is relatively secure. Additionally, the use of a flexible sleeve further prevents the guide component from being pulled out of the balloon during catheter removal, effectively ensuring the structural integrity of the guide component after catheter removal and helping to prevent filler leakage. In this embodiment, the guide component 10 does not need to be fixed to the balloon body over a large area; it can be free at any position in the balloon 2, allowing the catheter 3 to be removed along the channel without additional friction caused by the bending of the catheter 3, thus reducing the pull-out force of the catheter 3.

[0193] The following points should be noted in this article:

[0194] (1) The accompanying drawings of the embodiments of this disclosure only involve the structures involved in the embodiments of this disclosure. Other structures can be referred to the general design.

[0195] (2) Where there is no conflict, the embodiments of this disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

[0196] (3) The above description is merely an exemplary embodiment of this disclosure and is not intended to limit the scope of protection of this disclosure. The scope of protection of this disclosure is determined by the appended claims.

Claims

1. A closed structure for a capsule, characterized in that, The capsule includes a capsule wall, and the closure structure includes: A guiding component penetrates and connects to the capsule wall, the connection point of the guiding component on the capsule wall serving as an interface for the capsule. The guiding component has a guiding channel configured to temporarily accommodate a guide, the guiding channel including a first opening located on the outer side of the capsule wall, and the guiding component including a first end located on the outer side of the capsule wall and surrounding the first opening. The capsule wall includes a first wall and a second wall, and the guiding assembly is located between the first wall and the second wall and includes: First flexible layer; and A second flexible layer is stacked on top of the first flexible layer in the thickness direction and partially connected to each other to define the guide channel located between the first flexible layer and the second flexible layer. The guiding channel further includes a second opening located on the inner side of the cyst wall; The guide channel penetrates the capsule wall and is perpendicular to the tangential plane of the capsule wall at the interface. The guide channel includes a first channel portion and a second channel portion that are connected in a first direction. The first channel portion is located outside the capsule wall and defines the first opening, and the second channel portion is located inside the capsule wall and defines the second opening. The width of at least one of the first channel portion and the second channel portion increases in the direction away from the capsule wall.

2. The closure structure of the capsule according to claim 1, characterized in that, The closure structure further includes: a side wing, the side wing comprising a first portion located on the outer side of the capsule wall and a second portion located on the inner side of the capsule wall; The guiding component further includes: a second end located inside the capsule wall and surrounding the second opening; The first part is connected to the first end, and the second part is connected to the second end.

3. The closure structure of the capsule according to claim 1, characterized in that, The guide channel further includes a third channel portion connecting the first channel portion and the second channel portion, wherein the width of the third channel portion remains constant along the first direction; The first channel portion and the second channel portion are arranged symmetrically with respect to the third channel portion.

4. The closure structure of the capsule according to claim 1, characterized in that, The enclosed structure further includes: side wings, which are parallel to the plane in which the guide channel is located; The guide channel is perpendicular to the tangent plane of the capsule wall at the interface and includes: a first channel portion and a second channel portion connected in a first direction, and a third channel portion connecting the first channel portion and the second channel portion; The orthographic projection of the third channel portion onto the plane containing the side wing of the closed structure and the orthographic projection of the docking interface onto the plane containing the side wing at least partially overlap.

5. The closure structure of the capsule according to claim 4, characterized in that, The guide channel also includes: a boundary line located at the junction of the third channel portion and the first channel portion; Wherein, the orthographic projection of the interface on the plane where the side wing is located falls on the side of the orthographic projection of the boundary line on the plane where the side wing is located, closer to the second channel portion.

6. The closure structure of the capsule according to claim 1, characterized in that, The enclosed structure further includes: side wings, which are parallel to the plane in which the guide channel is located; The guide channel penetrates the capsule wall and is perpendicular to the tangential plane of the capsule wall at the interface; The wing includes: a first end and a second end opposite to each other in a second direction, the first end being close to and connected to the guide assembly, and the second end being away from the guide assembly, wherein the second direction is perpendicular to the first direction; In this case, part of the first end is located on the outer side of the cyst wall.

7. The closure structure of the capsule according to claim 6, characterized in that, The flank further includes a connecting portion connecting the first end and the second end, the connecting portion including a first outer edge and a second outer edge opposite to each other in the first direction, the first outer edge being located outside the capsule wall and the second outer edge being located inside the capsule wall; Wherein, at least one of the first outer edge and the second outer edge is non-linear.

8. The closure structure of the capsule according to claim 7, characterized in that, in, The vertical distance between the first end and the second end in the second direction is d, and the vertical distance d satisfies the following condition: Where a is the dimension of the guide channel in the first direction, and e is the dimension of the guide component in the second direction.

9. The closure structure of the capsule according to claim 1, characterized in that, The enclosed structure further includes: a side wing, wherein the thickness direction is perpendicular to the plane in which the side wing is located; Wherein, the first flexible layer and the second flexible layer at least partially define the opposing surfaces of the guide channel as having self-adhesive properties; At least one of the first flexible layer and the second flexible layer is connected to the side wing of the closed structure.

10. The closure structure of the capsule according to claim 9, characterized in that, At least one of the first flexible layer and the second flexible layer is made of the same material as the side wing and is an integral structure.

11. The closure structure of the capsule according to claim 9, characterized in that, The guide channel penetrates the interface and extends perpendicularly to the capsule wall in a first direction, and the side wings are parallel to the plane in which the guide channel is located; At least one of the first flexible layer and the second flexible layer includes a first side and a second side opposite to each other in a second direction parallel to the plane of the side wing, wherein the second direction is perpendicular to the first direction. The number of side wings is at least two, and the at least two side wings are located on the first side and the second side respectively, and are connected to the flexible layer on the first side and the second side respectively.

12. The closure structure of the capsule according to claim 1, characterized in that, The guiding channel further includes a second opening located on the inner side of the cyst wall; The guiding component further includes: a second end located inside the capsule wall and surrounding the second opening; The closed structure further includes: a flexible sleeve sleeved on and connected to the second end, the flexible sleeve having an opening, the flexible sleeve including a chamber communicating with the second opening, the chamber being configured to temporarily accommodate the guide.

13. The closure structure of the capsule according to claim 12, wherein, The enclosed structure further includes: a side wing, wherein the guide channel extends in a first direction parallel to the plane in which the side wing is located; Wherein, a portion of the second end is located in the cavity, and the dimension of the portion of the second end in a second direction parallel to the plane of the side wing of the closed structure is smaller than the dimension of the cavity in a second direction parallel to the plane of the side wing, the second direction being perpendicular to the first direction.

14. The closure structure of the capsule according to claim 13, characterized in that, The flexible sleeve includes: The third flexible layer; and A fourth flexible layer, wherein the third and fourth flexible layers are stacked in the thickness direction and partially connected to each other to define the cavity, the thickness direction being perpendicular to the plane containing the side wings.

15. The closure structure of the capsule according to claim 14, wherein, One of the third flexible layer and the fourth flexible layer is provided with the opening, the opening being configured to allow the guide located in the chamber to pass through and enter the sac.

16. A balloon system, characterized in that, include: The capsule is inflatable; and The closure structure of the capsule according to any one of claims 1 to 15.

17. The balloon system according to claim 16, characterized in that, The first wall and the second wall are connected to each other to define the accommodating space of the bladder, and the interface is disposed at the connection between the first wall and the second wall and communicates with the accommodating space.

18. The balloon system according to claim 17, characterized in that, The first wall has a first orthographic projection in the plane where the guide channel is located; The second wall has a second orthographic projection in the plane of the guide channel; The first orthographic projection and the second orthographic projection completely overlap.

19. The balloon system according to claim 17, characterized in that, The first wall has a first orthographic projection in the plane where the guide channel is located; The second wall has a second orthographic projection in the plane of the guide channel; The second orthographic projection falls within the first orthographic projection.

20. A method for manufacturing the balloon system of claim 18, characterized in that, include: Connect the closed structure to the first wall of the bladder; The second wall of the sac is connected to the first wall to form a sac wall having the interface, wherein the closure structure is located at the interface of the sac wall, and one of the first wall and the second wall is provided with a through hole; The capsule wall and the sealing structure are turned outwards from the inside through the through-hole; and The through-hole is covered with a cap to form a closed receiving space in the bladder wall.

21. The manufacturing method according to claim 20, characterized in that, The closed structure includes a guiding component, which includes a first end and a second end opposite to each other in a first direction, and a flexible sleeve is fitted onto the second end. In the step of connecting the second wall of the bladder to the first wall, the first end is located inside the bladder wall, and the second end and the flexible sleeve are located outside the bladder wall; After performing the step of turning the capsule wall and the closure structure outward from the through hole, the first end is located on the outside of the capsule wall, and the second end and the flexible sleeve are located on the inside of the capsule wall.

22. A method for manufacturing the balloon system of claim 19, characterized in that, include: The closed structure is connected to the second wall of the bladder, and the first wall is provided with a through hole; The second wall of the bladder is connected to the first wall to cover the through hole, thereby forming a bladder wall with the interface, wherein the closure structure is located at the interface of the bladder wall and forms a closed receiving space in the bladder wall.

23. The manufacturing method according to claim 22, characterized in that, The closed structure includes a guiding component, which includes a first end and a second end opposite to each other in a first direction, and a flexible sleeve is fitted onto the second end. In the step of connecting the second wall of the bladder to the first wall, the first end is located outside the bladder wall, and the second end and the flexible sleeve are located inside the bladder wall.

24. The manufacturing method according to claim 21 or 23, characterized in that, The flexible sleeve includes a chamber communicating with the guide channel, and the flexible sleeve is provided with an opening; The manufacturing method further includes: The guide is guided into the guide channel and passes through the chamber and out of the opening to enter the receiving space of the sac.

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