Anti-displacement bracket and its manufacturing method

Abstract

Embodiments of the present invention provide an anti-displacement stent and a manufacturing method thereof, which relate to the technical field of medical devices. The anti-displacement stent provided by the embodiments of the present invention includes a main body and a bare stent disposed outside the main body. The bare stent includes an anti-disengagement portion and a connecting portion connected to one end of the anti-disengagement portion. The connecting portion is connected to the main body, thereby connecting the bare stent to the main body. One end of the anti-disengagement portion away from the connecting portion is used to form a growth space with the main body, and a plurality of anti-disengagement holes communicating with the growth space are formed on the anti-disengagement portion. Therefore, when the anti-displacement stent is implanted into a human body lumen, tissues enter the growth space through the anti-disengagement holes, and thus grow in the growth space to fix the anti-displacement stent and prevent the stent from displacing. At the same time, since the connecting portion is disposed at one end of the anti-disengagement portion, an opening communicating with the growth space is formed at one end of the anti-disengagement portion away from the connecting portion, so that a larger growth space can be obtained and the anti-disengagement effect is better.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly, to an anti-displacement stent and a manufacturing method thereof. Background Art

[0002] Due to various reasons and lesions, the body's lumens (such as the esophagus, intestine, etc.) may cause diseases such as stenosis or obstruction. Currently, the common treatment method is to implant a stent at the stenotic or obstructive site to ensure the patency of the corresponding part of the lumen.

[0003] However, after the stent is implanted into the body lumen, various complications are likely to occur. The most common one is stent displacement. After the stent is displaced, the recurrence of the original symptoms will occur. Therefore, in order to ensure the treatment effect, it is necessary to reset the original stent or implant a new stent under endoscopy, which undoubtedly increases the pain and economic burden of the patient.

[0004] Therefore, in order to prevent the problem of stent displacement, currently, some stents have anti-displacement designs. However, the existing stents with anti-displacement designs still have the problem of poor anti-displacement effect. Summary of the Invention

[0005] The objectives of the present invention include, for example, providing an anti-displacement stent that can improve the problem of poor anti-displacement effect of anti-displacement stents in the prior art.

[0006] The objectives of the present invention further include providing a manufacturing method for an anti-displacement stent, which is used to manufacture the above-mentioned anti-displacement stent.

[0007] The embodiments of the present invention can be implemented as follows:

[0008] The embodiments of the present invention provide an anti-displacement stent, which includes a main body and a bare frame located outside the main body; the bare frame includes an anti-disengagement part and a connecting part connected to one end of the anti-disengagement part; the connecting part is connected to the main body, the anti-disengagement part is used to form a growth space with the main body, and one end of the anti-disengagement part away from the connecting part is used to form an opening communicating with the first growth space with the main body; the anti-disengagement part has a plurality of anti-disengagement holes penetrating through and communicating with the growth space, so that tissues can enter the growth space through the anti-disengagement holes.

[0009] Optionally, the anti-disengagement part and the main body are arranged at intervals to form the growth space.

[0010] Optionally, the main body has a flexible part, the anti-disengagement part is located outside the flexible part, and the flexible part is used to generate deformation so that a growth space is formed between the flexible part and the anti-disengagement part.

[0011] Optionally, the anti-disengagement part is annular and sleeved outside the main body.

[0012] Optionally, the connecting part includes a plurality of sub-connecting parts, and the plurality of sub-connecting parts are sequentially arranged along the circumferential direction of the anti-disengagement part at one end of the anti-disengagement part.

[0013] Optionally, the anti-disengagement holes are distributed in a matrix to form a grid structure.

[0014] Optionally, the anti-disengagement part is a mesh structure made of metal wire weaving, and the anti-disengagement holes are the mesh holes of the mesh structure.

[0015] Optionally, the body includes an intermediate section and two cup mouth sections, the two cup mouth sections are respectively arranged at both ends of the intermediate section, and the radial dimension of the cup mouth section is greater than the radial dimension of the intermediate section; the bare frame is located outside the cup mouth section.

[0016] Optionally, the connecting part is connected to the intermediate section.

[0017] Optionally, the connecting part is arranged at an interval from the intermediate section; the anti-displacement bracket further includes a first connecting wire, and the connecting part is fixedly connected to the intermediate section through the first connecting wire.

[0018] Optionally, the anti-displacement bracket further includes a first coating film arranged outside the connecting part and the intermediate section, and both ends of the first coating film are fixedly connected to the connecting part and the intermediate section respectively.

[0019] Optionally, the cup mouth section includes a large-diameter section, a connecting section and a small-diameter section, and the radial dimension of the large-diameter section is greater than the radial dimension of the intermediate section; both ends of the connecting section are fixedly connected to the large-diameter section and the small-diameter section respectively, and the small-diameter section is connected to the intermediate section; the bare frame extends from outside the large-diameter section to outside the small-diameter section.

[0020] Optionally, the growth space includes a first growth space; the first growth space is formed between the bare frame and the large-diameter section.

[0021] Optionally, the growth space further includes a second growth space; the bare frame is arranged at an interval from the connecting section to form the second growth space between the bare frame and the connecting section.

[0022] Optionally, the intermediate section includes a plurality of first frame bodies arranged at intervals, and adjacent first frame bodies are connected through a connecting structure.

[0023] Optionally, the connecting structure includes a second connecting wire, and adjacent two first frame bodies are connected through the second connecting wire.

[0024] Optionally, the middle section further includes a second coating film disposed on the connecting structure and the plurality of first frames.

[0025] Optionally, the cup mouth section includes a second frame and a third coating film disposed on the second frame, and the bare frame is located outside the second frame.

[0026] Optionally, the anti-displacement bracket further includes skirts disposed at both ends of the body.

[0027] Optionally, the anti-displacement bracket further includes a particle sac fixed on the body, and the particle sac is used for filling iodine particles.

[0028] Optionally, the anti-displacement bracket further includes a first recovery rope and a second recovery rope; the first recovery rope is disposed on the body and is used to pull the body under the action of an external force to change the outer diameter of the body; the second recovery rope is disposed at one end of the anti-disengagement portion away from the connecting portion and is used to pull the anti-disengagement portion under the action of an external force to change the outer diameter of the anti-disengagement portion.

[0029] An embodiment of the present invention further provides a manufacturing method of an anti-displacement bracket. This method is used to manufacture the above anti-displacement bracket. The manufacturing method of the anti-displacement bracket includes: disposing the anti-disengagement portion of the bare frame outside the body and connecting the connecting portion of the bare frame to the body.

[0030] Optionally, the step of disposing the anti-disengagement portion of the bare frame outside the body and connecting the connecting portion of the bare frame to the body includes:

[0031] Putting the anti-disengagement portion on the cup mouth section of the body; using a first connecting line to connect the connecting portion and the end of the cup mouth section to the middle section of the body at the same time; coating the connecting portion and the area from the connecting portion to the middle section.

[0032] The beneficial effects of the anti-displacement bracket and its manufacturing method according to the embodiments of the present invention include, for example:

[0033] An embodiment of the present invention provides an anti-displacement bracket, which includes a body and a bare frame disposed outside the body. The bare frame includes an anti-disengagement portion and a connecting portion connected to one end of the anti-disengagement portion. The connecting portion is connected to the body, thereby connecting the bare frame to the body. The anti-disengagement portion is used to form a growth space with the body, and a plurality of anti-disengagement holes communicating with the growth space are provided on the anti-disengagement portion. Therefore, when the anti-displacement bracket is implanted into the human body lumen, the tissue of the human body lumen enters the growth space through the anti-disengagement holes, and then grows in the growth space to fix the anti-displacement bracket and prevent the bracket from shifting. At the same time, since the connecting portion is disposed at one end of the anti-disengagement portion, an opening communicating with the growth space is formed at one end of the anti-disengagement portion away from the connecting portion, so that a larger growth space can be obtained and the anti-disengagement effect is better.

[0034] An embodiment of the present invention further provides a manufacturing method for the anti-displacement bracket, and this manufacturing method is used to manufacture the above-mentioned anti-displacement bracket. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and thus should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings.

[0036] Figure 1 Schematic diagram of the overall structure of the anti-displacement bracket provided by the embodiment of the present invention from the first perspective;

[0037] Figure 2 is Figure 1 Enlarged schematic diagram of the partial structure at II in;

[0038] Figure 3 Schematic diagram of the partial structure of the anti-displacement bracket provided by the embodiment of the present invention from the second perspective;

[0039] Figure 4 Schematic diagram of the partial structure of another anti-displacement bracket provided by the embodiment of the present invention;

[0040] Figure 5 Schematic diagram of the sectional structure at the cup mouth section of the anti-displacement bracket provided by the embodiment of the present invention;

[0041] Figure 6 Schematic diagram of the partial structure of the anti-displacement bracket provided by the embodiment of the present invention from the third perspective;

[0042] Figure 7 Schematic diagram of the sectional structure of the particle sac in the anti-displacement bracket provided by the embodiment of the present invention.

[0043] Reference numerals: 10 - anti-displacement bracket; 100 - body; 110 - cup mouth section; 111 - second frame body; 112 - third film; 113 - large diameter section; 114 - connecting section; 115 - small diameter section; 116 - second sub-connecting portion; 120 - middle section; 121 - first frame body; 122 - second connecting line; 123 - second film; 130 - skirt; 200 - bare frame; 210 - connecting portion; 211 - first sub-connecting portion; 220 - anti-displacement portion; 221 - anti-displacement hole; 222 - first anti-displacement section; 223 - second anti-displacement section; 230 - first connecting line; 240 - first film; 310 - first recovery cord; 320 - second recovery cord; 330 - particle sac; 410 - first growth space; 420 - second growth space. Detailed implementation manners

[0044] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Apparently, the described embodiments are some but not all of the embodiments of the present invention. The components of the embodiments of the present invention described and illustrated herein usually can be arranged and designed in various different configurations.

[0045] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the scope of protection of the present invention.

[0046] It should be noted that: like reference numerals and letters denote similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0047] In the description of the present invention, it should be noted that if terms such as "upper", "lower", "inner", "outer", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the present invention is normally placed, it is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as a limitation of the present invention.

[0048] In addition, terms such as "first", "second", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0049] It should be noted that the features in the embodiments of the present invention can be combined with each other without conflict.

[0050] Figure 1 FIG. 23 is a schematic diagram of the overall structure of the anti-displacement bracket 10 provided for this embodiment from a first perspective. Figure 2 is Figure 1 a partially enlarged schematic diagram of part II in FIG. Figure 1 and Figure 2, this embodiment provides a displacement prevention bracket 10, which includes a main body 100 and a bare bracket 200 disposed outside the main body 100. The bare bracket 200 includes an anti - detachment portion 220 and a connecting portion 210 connected to one end of the anti - detachment portion 220. The connecting portion 210 is connected to the main body 100, thereby connecting the bare bracket 200 to the main body 100. The anti - detachment portion 220 is used to form a growth space with the main body 100, and a plurality of anti - detachment holes 221 communicating with the growth space are formed on the anti - detachment portion 220. Therefore, when the displacement prevention bracket 10 is implanted into a human body lumen (such as the esophagus, intestine, etc.), the tissue of the human body lumen (for example, when the bracket is inserted into the esophagus of the human body, the tissue is the tissue at the inner wall of the human esophagus) will contact the anti - detachment portion 220, and part of the tissue will enter the growth space through the anti - detachment holes 221 and grow in the growth space to fix the displacement prevention bracket 10 for positioning and prevent the bracket from shifting. At the same time, since the connecting portion 210 is disposed at one end of the anti - detachment portion 220, only one end of the bare bracket 200 is connected to the main body 100, and the other end forms a free end. An opening communicating with the growth space is formed at the end of the anti - detachment portion 220 far from the connecting portion 210, so as to obtain a larger growth space and better anti - detachment effect.

[0051] The following further describes the displacement prevention bracket 10 provided in this embodiment:

[0052] Please refer to Figure 1 , in this embodiment, the main body 100 includes an intermediate section 120 and two cup - mouth sections 110. The two cup - mouth sections 110 are respectively the first cup - mouth section and the second cup - mouth section. The intermediate section 120, the first cup - mouth section, and the second cup - mouth section are all circular tubes. The first cup - mouth section and the second cup - mouth section are respectively disposed at both axial ends of the intermediate section 120. At the same time, the radial dimensions of the first cup - mouth section and the second cup - mouth section are larger than the radial dimension of the intermediate section 120, thereby forming a dumbbell - shaped main body 100. Specifically, the length of the cup - mouth section 110 is a, 14mm ≤ a ≤ 16mm. The length between the first cup - mouth section and the second cup - mouth section is specifically set according to the size of the lesion site. In this embodiment, the length between the first cup - mouth section and the second cup - mouth section is b, 40mm ≤ b ≤ 150mm. Optionally, a = 14mm, 15mm or 16mm; b = 40mm, 100mm or 150mm.

[0053] Please refer to Figure 2, the cup mouth section 110 includes a second frame body 111 and a third film layer 112 covering the second frame body 111. Therefore, the external shape features of the second frame body 111 are the external shape features of the cup mouth section 110. The second frame body 111 is a net-shaped cylinder woven from a single nickel-titanium wire. By covering a film on the second frame body 111, the third film layer 112 is formed to close the mesh holes on the second frame body 111, preventing tissue from passing through the mesh holes on the second frame body 111 and entering the inside of the anti-displacement stent 10 after the anti-displacement stent 10 is placed in the human body lumen. Optionally, the third film layer 112 is formed by immersing the second frame body 111 in liquid silicone. After the liquid material covers all the mesh holes, the second frame body 111 is taken out and cooled to form the second frame body 111 covered with the third film layer 112.

[0054] The bare frame 200 includes an anti-disengagement part 220 and a connecting part 210 connected to one end of the anti-disengagement part 220. The connecting part 210 is connected to the main body 100, thereby connecting the anti-disengagement part 220 to the main body 100. In this embodiment, the anti-disengagement part 220 is located outside the cup mouth section 110. The connecting part 210 is connected to the end of the middle section 120. One end of the anti-disengagement part 220 away from the connecting part 210 forms a free end. Specifically, the number of the bare frames 200 is two. The two bare frames 200 are respectively arranged outside the first cup mouth section and the second cup mouth section, and the connecting parts 210 of the two bare frames 200 are respectively connected to the two axial ends of the middle section 120. A growth space is formed between the anti-disengagement part 220 and the cup mouth section 110, and a plurality of anti-disengagement holes 221 communicating with the growth space are provided on the anti-disengagement part 220. Since the second frame body 111 constituting the cup mouth section 110 is covered with the third film layer 112, the tissue entering the first growth space 410 from the anti-disengagement holes 221 cannot pass through the second frame body 111 and continue to grow into the inner side of the cup mouth section 110 due to the blockage of the third film layer 112. Thus, it avoids causing restenosis again, and at the same time ensures that the anti-displacement stent 10 can be smoothly recovered after the diseased part of the human body lumen is cured.

[0055] By arranging the bare frame 200 outside the cup mouth section 110, a double-layer structure is formed for the cup mouth section 110 of the anti-displacement stent 10, and the middle section 120 is a single-layer structure. Since the length of the cup mouth section 110 is small, after arranging the bare frame 200 outside the cup mouth section 110, not only a good anti-displacement effect can be obtained, but also the influence of the anti-displacement stent 10 on the tissue at the narrow part of the human body lumen is small. This structure can avoid affecting the overall mechanical properties of the anti-displacement stent 10 while exerting the anti-displacement function, and further avoid the problems of tissue necrosis and perforation caused by excessive stent support force compressing the tissue at the narrow part in the lumen. It can be understood that in other embodiments, the position of the bare frame 200 can also be specifically set according to requirements.

[0056] Furthermore, the entire bare frame 200 is annular, that is, both the anti-displacement part 220 and the connecting part 210 are annular. The anti-displacement part 220 is sleeved on the cup mouth section 110, so that an annular growth space is formed between the end of the anti-displacement part 220 far from the connecting part 210 and the cup mouth section 110. Along the circumferential direction of the cup mouth section 110, tissues can grow into the growth space evenly, and the anti-displacement effect is better.

[0057] In this embodiment, multiple anti-displacement holes 221 on the bare frame 200 are distributed in a matrix, thus forming a grid structure, so that tissues can enter the first growth space 410 evenly through the anti-displacement holes 221. Furthermore, the bare frame 200 is a mesh structure made of metal wires woven, that is, the anti-displacement part 220 is a mesh structure made of metal wires woven, and the anti-displacement holes 221 are grid holes formed between adjacent metal wires in this mesh structure. It should be noted that in this embodiment, the anti-displacement holes 221 are diamond-shaped grid holes. It can be understood that in other embodiments, the shape of the anti-displacement holes 221 can also be specifically set according to requirements. For example, the anti-displacement holes 221 can be set as circular, strip-shaped or triangular, etc., as long as tissues can enter the growth space through the anti-displacement holes 221.

[0058] Optionally, the bare frame 200 is made of a single metal wire woven. The connecting part 210 is multiple protruding meshes formed by metal wires at the end of the bare frame 200. Each protruding mesh forms a sub-connecting part, and this sub-connecting part is the first sub-connecting part 211. Multiple first sub-connecting parts 211 are arranged in sequence along the circumferential direction of the anti-displacement part 220 at one end of the anti-displacement part 220. Optionally, the material of the metal wire is nickel-titanium alloy. It can be understood that in other embodiments, other materials can also be selected to make the bare frame 200 according to requirements.

[0059] Figure 3 This is a partial structural schematic diagram of the anti-displacement bracket 10 provided in this embodiment from the second perspective. Please refer to Figure 3, since the second frame body 111 is a mesh structure woven from a single nickel-titanium wire, multiple protruding meshes are also formed at the end of the mesh structure, and each protruding mesh forms a sub-connection part, which is the second sub-connection part 116. In this embodiment, the anti-displacement bracket 10 further includes a first connecting line 230, and the connecting part 210 and the middle section 120 are connected by the first connecting line 230. Specifically, the second sub-connection part 116 and the first sub-connection part 211 are arranged corresponding to each other, that is, the meshes forming the first sub-connection part 211 overlap with the meshes forming the second sub-connection part 116. During the process of connecting the connecting part 210 and the middle section 120 by the first connecting line 230, the first connecting line 230 passes through the middle section 120 and then bypasses the first sub-connection part 211 and the second sub-connection part 116 at the same time and then passes through the middle section 120 again. The first connecting line 230 is alternately wound along the circumferential direction of the body 100 at the overlapping position of the middle section 120 and the first sub-connection part 211 and the second sub-connection part 116, so as to connect the bare frame 200 and the cup mouth section 110 with the middle section 120. Optionally, the first connecting line 230 is a soft wire, so that the connection part is in a soft state, enabling the anti-displacement bracket 10 to better conform to the peristalsis of the human body lumen.

[0060] The first sub-connection part 211 and the second sub-connection part 116 are arranged corresponding to each other one by one, and each second sub-connection part 116 overlaps with the corresponding first sub-connection part 211. Further, the first connecting line 230 bypasses each first connection part 210 and the second sub-connection part 116. In this way, the end of the bare frame 200 is wrapped by the first connecting line 230, avoiding the end of the bare frame 200 from stabbing tissues and causing damage to the human body.

[0061] Further, the anti-displacement bracket 10 further includes a first film 240 arranged outside the connecting part 210 and the middle section 120, and both ends of the film are fixedly connected to the connecting part 210 and the middle section 120 respectively. By arranging the first film 240, the holes generated by the first connecting line 230 winding back and forth are closed, preventing tissues from growing into the anti-displacement bracket 10 through these holes. At the same time, the first film 240 extends to cover the meshes forming the first sub-connection part 211. Therefore, the end of the bare frame 200 near the middle section 120 is covered by the first film 240, further avoiding the end of the bare frame 200 from stabbing tissues and causing damage to the human body. Correspondingly, the formation method of the first film 240 can refer to the formation method of the third film 112 above.

[0062] It should be noted that in this embodiment, by arranging the first film 240 and setting the first connecting rope to bypass each first sub-connection part 211, the end of the bare frame 200 is prevented from stabbing tissues. It can be understood that in other embodiments, it can also be specifically set according to requirements. For example Figure 4 as shown, the first connecting rope is arranged to wind around the first sub-connection part 211 at intervals.

[0063] Figure 5 This is a cross-sectional structural diagram of the cup opening section 110 of the anti-displacement bracket 10 provided in this embodiment, and only the bare frame 200 is cut in this cross-sectional diagram. Figure 5 In this embodiment, the second frame 111 includes a large diameter section 113, a connecting section 114, and a small diameter section 115, which are arranged in sequence. The large diameter section 113, the connecting section 114, and the small diameter section 115 are integrally formed by braiding nickel-titanium wire. The second sub-connecting portion 116 of the second frame 111 is formed at the end of the small diameter section 115 away from the large diameter section 113. The two ends of the connecting section 114 are fixedly connected to the large diameter section 113 and the small diameter section 115, respectively. The large diameter section 113 and the small diameter section 115 are both cylindrical structures. Obviously, the radial dimension of the large diameter section 113 is larger than the radial dimension of the small diameter section 115. The radial dimension of the small diameter section 115 is the same as the radial dimension of the middle section 120, and the radial dimension of the large diameter section 113 is larger than the radial dimension of the middle section 120.

[0064] Bare frame 200 is sleeved outside cup-shaped section 110, with the end of bare frame 200 away from connecting portion 210 positioned outside large-diameter section 113. Connecting portion 210 of bare frame 200 extends axially over connecting section 114 and then overlaps with second sub-connecting portion 116 located in small-diameter section 115. Furthermore, bare frame 200 and connecting section 114 are spaced apart, forming a gap between them.

[0065] Specifically, the anti-slip portion 220 includes a first anti-slip section 222 and a second anti-slip section 223 that are interconnected. The first anti-slip section 222 is covered on the outside of the large diameter section 113, and the growth space includes a first growth space 410 formed between the first anti-slip section 222 and the large diameter section 113. Since the cup mouth section 110 is made by covering the second frame 111 woven from a single nickel-titanium wire with a third coating 112, the large diameter section 113 can not only support the narrow part of the human body's lumen, but also has a certain flexibility, forming a flexible part of the main body 100. Therefore, in the process of tissue growing through the anti-slip hole 221 toward the large diameter section 113, the tissue resists the large diameter section 113, causing the large diameter section 113 to deform slightly, so that the large diameter section 113 is separated from the first anti-slip section 222 to form a gap as the first growth space 410, and the tissue is as Figure 2 The direction indicated by the middle arrow passes through the anti-slip hole 221 on the first anti-slip section 222 and grows into the first growth space 410 to play an anti-slip role. The second anti-slip section 223 is spaced apart from the connecting section 114, and the growth space includes a second growth space 420 formed between the second anti-slip section 223 and the connecting section 114. After the anti-displacement stent 10 is implanted in the human body lumen, part of the tissue passes through the anti-slip hole 221 on the second anti-slip section 223 and enters the second growth space 420 (as shown in FIG. Figure 5The arrow in [description] indicates the growth direction of the tissue), thus playing a good fixing role to fix the anti-displacement bracket 10 in the human lumen and prevent displacement.

[0066] It should be noted that in this embodiment, the cup mouth section 110 has flexibility, which not only enables the anti-displacement bracket 10 to have good compliance and reduces the impact of the anti-displacement bracket 10 on the human body, but also forms a growth space through the deformation of the cup mouth section 110 to allow tissue to grow into the first growth space, thereby fixing the anti-displacement bracket 10 and preventing the bracket from displacing. It can be understood that in other embodiments, the anti-disengagement part 220 can also be arranged at an interval from the cup mouth section 110, and a gap serving as the first growth space 410 is formed between the end of the anti-disengagement part 220 far from the connecting part 210 and the cup mouth section 110.

[0067] The connecting section 114 is an annular shape extending along the radial direction of the main body 100. The outer periphery of this annular shape is fixedly connected to one end of the large-diameter section 113 in the axial direction, and the connecting section 114 is arranged substantially perpendicular to the large-diameter section 113; the inner ring of the annular shape is fixedly connected to one end of the small-diameter section 115 in the axial direction, and the connecting section 114 is arranged substantially perpendicular to the small-diameter section 115. A tapered section with a gradually decreasing radial dimension in the direction from the large-diameter section 113 to the small-diameter section 115 is provided on the bare frame 200, and this tapered section is the second anti-disengagement section 223. The second anti-disengagement section 223 is arranged at a position corresponding to the connecting section 114. Therefore, in the sectional view as Figure 5 shown, the connecting section 114, the second anti-disengagement section 223, and the small-diameter section 115 enclose a triangular cavity, and this cavity is the second growth space 420. Further, the connection between the connecting section 114 and the large-diameter section 113 is smoothly transitioned through an arc section, and the connection between the connecting section 114 and the small-diameter section 115 is smoothly transitioned through an arc section.

[0068] It can be understood that in other embodiments, the connecting section 114 can also be set according to requirements. For example, the connecting section 114 can be set as a frustum of a cone with a cone angle smaller than that of the tapered section, which can enable the connecting section 114 to be arranged at an interval from the second anti-disengagement section 223, and then a gap serving as the second growth space 420 is formed between the connecting section 114 and the second anti-disengagement section 223.

[0069] Figure 6 This is a partial structural schematic diagram of the anti-displacement bracket 10 provided in this embodiment from the third perspective. Please refer to Figure 6, in this embodiment, the anti-displacement bracket 10 further includes skirts 130 provided at both ends of the body 100. Specifically, the skirts 130 are annular silicone molds, which are located at the end of the cup mouth section 110 far from the middle section 120, and are adhered to the outer peripheral surface of the cup mouth section 110. That is, the skirts 130 are located between the cup mouth section 110 and the bare bracket 200, and at the same time, the skirts 130 protrude from the cup mouth section 110 and the bare bracket 200. By providing the skirts 130, the irritation of the two ends of the anti-displacement bracket 10 to the tissue is reduced, and the tissue hyperplasia at both ends of the anti-displacement bracket 10 is prevented, and the tissue at both ends of the anti-displacement bracket 10 is prevented from growing into the anti-displacement bracket 10 from both ends.

[0070] Please refer to Figure 1 , in this embodiment, the middle section 120 of the body 100 includes a plurality of first brackets 121 arranged at intervals, and adjacent two first brackets 121 are connected by a connection structure. By setting the middle section 120 as a plurality of spaced first brackets 121, the body 100 has good compliance to conform to the peristalsis of the human body lumen and reduce the impact on the human body. Specifically, in this embodiment, the number of the first brackets 121 is four. It can be understood that in other embodiments, the number of the first brackets 121 can also be set according to the specific requirements of the overall length of the middle section 120, such as setting the number of the first brackets 121 to three, etc. Optionally, each first bracket 121 is a mesh structure woven from a single nickel-titanium wire.

[0071] Further, the connection structure includes a second connecting line 122, and the second connecting line 122 is a soft line, so as to ensure that the body 100 has good compliance. The second connecting line 122 alternately passes through adjacent two first brackets 121 to connect adjacent two first brackets 121. Since the first bracket 121 is a mesh structure made of nickel-titanium wire woven, the second connecting line 122 sequentially passes through the meshes located at the edge of the first bracket 121 for connection. Optionally, the second connecting line 122 is arranged to bypass each mesh located at the edge of one end of the first bracket 121 to wrap the edge of the first bracket 121 and prevent the edge of the first bracket 121 from stabbing the tissue. It can be understood that one end of the first bracket 121 at both ends of the middle section 120 for connecting with the cup mouth section 110 and the bare bracket 200 is wrapped by the first connecting line 230 to prevent stabbing the tissue.

[0072] Further, the middle section 120 further includes a second film 123, which covers multiple first frameworks 121 and second connecting ropes disposed between two adjacent first frameworks 121, so as to seal the mesh holes on the first frameworks 121 and the holes formed by threading the second connecting ropes back and forth, preventing tissue from passing through the middle section 120 and entering the anti-displacement stent 10. Thus, the whole anti-displacement stent 10 is fully covered with films except for the anti-disengagement part 220 of the bare frame 200, which can effectively prevent polyp tissue from growing into the anti-displacement stent 10. Correspondingly, the formation method of the second film 123 can refer to the formation method of the third film 112 described above.

[0073] Figure 7 Schematic cross-sectional structure diagram of the particle capsule in the anti-displacement stent provided in this embodiment. Please refer to Figure 1 and Figure 7 , in this embodiment, the anti-displacement stent 10 further includes a particle capsule 330 fixedly connected to the main body 100. The particle capsule 330 is used for filling iodine particles. Specifically, the particle capsule 330 is fixed to the middle section 120 of the main body 100 by suture. Further, multiple particle capsules 330 are evenly distributed on the middle section 120. During use, the doctor precisely calculates the number and position distribution of iodine particles to be carried according to requirements, such as the size of the patient's tumor, specific condition, etc., to form a preset plan, and installs the radioactive iodine particles in the corresponding particle capsules 330 in sequence according to the preset plan during the operation, so that the iodine particles are implanted into the human body lumen along with the anti-displacement stent 10 to play a therapeutic role.

[0074] Please refer to Figure 2 , in this embodiment, the anti-displacement stent 10 further includes a first recovery rope 310 and a second recovery rope 320. Since one end of the bare frame 200 away from the connecting part 210 is a free end, the main body 100 and the bare frame 200 can be controlled separately through the first recovery rope 310 and the second recovery rope 320. The first recovery rope 310 is disposed on the main body 100 and can pull the main body 100 under an external force to change the outer diameter at the corresponding position of the main body 100, so that the main body 100 is disengaged from the tissue at this position. The second recovery rope 320 is disposed at one end of the anti-disengagement part 220 away from the connecting part 210 and can pull the anti-disengagement part 220 under an external force to change the outer diameter at the corresponding position of the anti-disengagement part 220, so that the anti-disengagement part 220 is disengaged from the tissue, thereby enabling the anti-displacement stent 10 to be recovered more easily and avoiding damage to the tissue during the recovery process.

[0075] Specifically, the first recovery rope 310 is wound around the grid at one end of the cup mouth section 110 far from the middle section 120. By pulling the first recovery rope 310, the end of the cup mouth section 110 far from the middle section 120 shrinks and becomes smaller, so that the tissue growing into the first growth space 410 and the second growth space 420 is separated from the cup mouth section 110. The second recovery rope 320 is wound around one end of the bare frame 200 far from the connecting part 210, that is, the second recovery rope 320 is wound around the grid at the free end of the bare frame 200. By pulling the second recovery rope 320, the free end of the bare frame 200 shrinks and becomes smaller, so that the tissue passing through the grid holes on the bare frame 200 and growing into the first growth space 410 and the second growth space 420 is separated from the bare frame 200, making it easier to pull the anti-displacement bracket 10 out of the human body, and then recovering the anti-displacement bracket 10. At the same time, tissue damage is avoided during the recovery process.

[0076] It should be noted that in this embodiment, the first recovery rope 310 and the second recovery rope 320 are provided at both ends of the anti-displacement bracket 10. It can be understood that in other embodiments, the first recovery rope 310 and the second recovery rope 320 can also be provided only at one end of the anti-displacement bracket 10 according to requirements.

[0077] According to an anti-displacement bracket 10 provided in this embodiment, the working principle of the anti-displacement bracket 10:

[0078] First, iodine particles are sequentially placed into the particle sac 330 according to specific requirements. Then, through operations such as surgery, the anti-displacement bracket 10 is implanted into the lumen of the diseased part of the human body. The anti-displacement bracket 10 supports the narrow or blocked part of the lumen to ensure the patency of the lumen. As the time for the anti-displacement bracket 10 to enter the human body lumen increases, tissue grows through the anti-detachment holes 221 (i.e., the grid holes) on the bare frame 200 into the first growth space 410 and the second growth space 420. After the lumen is treated and the tumor gradually subsides and the stenosis gradually alleviates, the anti-displacement bracket 10 can be fixed by the tissue located in the first growth space 410 and the second growth space 420, thereby preventing the stent from shifting.

[0079] After the treatment is completed, first pull the first recovery rope 310 to make the cup mouth section 110 contract and separate from the tissue. Then pull the second recovery rope 320 to loosen the tissue growing through the bare frame 200 and finally separate it from the bare frame 200. The grasping force of the tissue on the bare frame 200 disappears. At the same time, since the tissue is separated from the cup mouth section 110 by pulling the first recovery rope 310 before pulling the second recovery rope 320, the tissue in the growth space can be effectively prevented from being damaged by the clamping of the cup mouth section 110 and the bare frame 200 during the process of pulling the second recovery rope 320 to separate the tissue from the bare frame 200. Finally, pull the first recovery rope 310 and the second recovery rope 320 simultaneously to recover the whole stent.

[0080] The anti-displacement stent 10 provided in this embodiment has at least the following advantages:

[0081] An embodiment of the present invention provides an anti-displacement stent 10, the body 100 of which is a fully covered film structure, so it can effectively prevent tissue hyperplasia from growing into the anti-displacement stent 10 and ensure the smooth recovery of the stent. At the same time, outside the cup mouth section 110 of the body 100, there is a bare frame 200 with one end connected to the middle section 120 and the other end being a free end. A first growth space 410 and a second growth space 420 are formed between the bare frame 200 and the cup mouth section 110. When in use, tissue can pass through the anti-displacement holes 221 on the bare frame 200 and grow into the first growth space 410 and the second growth space 420, thereby fixing the anti-displacement stent 10 and preventing the stent from shifting before removal, and further avoiding secondary damage to the human body. The bare frame 200 is connected to the middle section 120 through a first connecting line 230 and a first covering film 240. At the same time, the middle section 120 is provided with a plurality of first frame bodies 121 arranged at intervals, thus ensuring that the anti-displacement stent 10 has good compliance to conform to the peristalsis of the lumen. Moreover, the anti-displacement stent 10 provided in this embodiment can effectively prevent tissue from being stabbed and has good use effects.

[0082] This embodiment also provides a manufacturing method of an anti-displacement stent to manufacture the above anti-displacement stent. Specifically, the manufacturing method of the anti-displacement stent includes:

[0083] S01: Set the anti-displacement part of the bare frame outside the body and connect the connecting part of the bare frame to the body.

[0084] Connect a plurality of first frame bodies in series through a second connecting rope, and then perform film covering on the series-connected structure to form a middle section with a second covering film. It can be understood that in other embodiments, a middle section that has already been manufactured can also be used to manufacture the anti-displacement stent.

[0085] Perform film covering on the second frame body to form a cup mouth section with a third covering film. It can be understood that in other embodiments, a cup mouth section that has already been manufactured can also be used to manufacture the anti-displacement stent.

[0086] Set the bare frame outside the cup mouth section. At this time, the anti-displacement part of the bare frame is sleeved outside the cup mouth section. Use a first connecting line to connect the connecting part and the end of the cup mouth section to the middle section at the same time, so that the cup mouth section and the middle section are connected to form the body, and at the same time the bare frame is also fixed on the body. Finally, perform film covering on the connecting part of the bare frame and the area between the connecting part and the middle section to form a first covering film.

[0087] As described above, this is only the specific implementation manner of the present invention. However, the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims described above.

Claims

1. An anti-displacement bracket, characterized in that: The invention comprises a body and a bare frame located outside the body; the bare frame comprises an anti-detachment portion and a connecting portion connected to one end of the anti-detachment portion; the connecting portion is connected to the body, the anti-detachment portion is used to form a growth space with the body, and one end of the anti-detachment portion away from the connecting portion is used to form an opening between the body and the growth space; the anti-detachment portion has a plurality of anti-detachment holes that penetrate the body and are connected to the growth space, so that tissue can enter the growth space through the anti-detachment holes; The body includes a middle section and two cup-mouth sections, the two cup-mouth sections are respectively arranged at both ends of the middle section, the connecting portion of the bare frame is connected to the middle section, and the end of the anti-slip portion away from the connecting portion forms a free end, and the bare frame is located outside the cup-mouth section; Wherein, the radial dimension of the cup mouth section is larger than the radial dimension of the middle section, and the length of the cup mouth section is smaller than the length of the middle section; The cup mouth section includes a large diameter section, a connecting section, and a small diameter section. The radial dimension of the large diameter section is larger than that of the middle section. The two ends of the connecting section are fixedly connected to the large diameter section and the small diameter section respectively, and the small diameter section is connected to the middle section. The bare frame extends from the outside of the large diameter section to the outside of the small diameter section. The anti-slip portion includes a first anti-slip section and a second anti-slip section connected to each other, the first anti-slip section is covered outside the large-diameter section, and the growth space includes a first growth space formed between the first anti-slip section and the large-diameter section; the second anti-slip section is spaced apart from the connecting section, and the growth space includes a second growth space formed between the second anti-slip section and the connecting section; The connecting portion is a plurality of protruding grids formed by metal wire at the end of the bare frame, each of which forms a first sub-connecting portion, and the plurality of first sub-connecting portions are sequentially arranged at one end of the anti-detachment portion along the circumference of the anti-detachment portion; the end of the cup mouth section is formed with a plurality of protruding grids, each of which forms a second sub-connecting portion, and the plurality of second sub-connecting portions are arranged overlapping with the corresponding first sub-connecting portions; The anti-displacement bracket also includes a first connecting line, which is alternately arranged along the circumference of the body at the middle section and the overlapping position of the first sub-connecting part and the second sub-connecting part to connect the bare frame and the cup mouth section with the middle section.

2. The anti-displacement bracket according to claim 1, characterized in that: The anti-slip portion is spaced apart from the body to form the growth space.

3. The anti-displacement bracket according to claim 1, characterized in that: The main body has a flexible portion, the anti-slip portion is located outside the flexible portion, and the flexible portion is used to generate deformation so as to form the growth space between the flexible portion and the anti-slip portion.

4. The anti-displacement bracket according to claim 1, characterized in that: The anti-slip portion is annular and is sleeved outside the main body.

5. The anti-displacement bracket according to claim 1, characterized in that: The anti-displacement bracket further includes a first coating provided outside the connecting portion and the middle section, and two ends of the first coating are fixedly connected to the connecting portion and the middle section respectively.

6. The anti-displacement bracket according to claim 1, characterized in that: The middle section includes a plurality of first frames arranged at intervals, and adjacent first frames are connected by a connecting structure.

7. The anti-displacement bracket according to claim 6, characterized in that: The connection structure includes a second connection line, and two adjacent first frames are connected via the second connection line.

8. The anti-displacement bracket according to claim 6, characterized in that: The middle section further includes a second covering film provided on the connecting structure and the plurality of first frames.

9. The anti-displacement bracket according to claim 1, characterized in that: The cup mouth section includes a second frame and a third covering film arranged on the second frame, and the bare frame is located outside the second frame.

10. The anti-displacement bracket according to claim 1, characterized in that: The anti-displacement bracket further includes skirts arranged at both ends of the body.

11. The anti-displacement bracket according to claim 1, characterized in that: The anti-displacement stent further comprises a particle capsule fixed on the body, and the particle capsule is used for filling iodine particles.

12. The anti-displacement bracket according to any one of claims 1 to 11, characterized in that: The anti-displacement bracket also includes a first recovery rope and a second recovery rope; the first recovery rope is arranged on the main body and is used to pull the main body under the action of external force to change the outer diameter of the main body; the second recovery rope is arranged at one end of the anti-detachment part away from the connecting part, and is used to pull the anti-detachment part under the action of external force to change the outer diameter of the anti-detachment part.

13. A method for manufacturing an anti-displacement bracket, used to manufacture the anti-displacement bracket according to any one of claims 1 to 12, characterized in that: include: The anti-detachment portion of the bare frame is arranged outside the main body, and the connecting portion of the bare frame is connected to the main body.

14. The method for manufacturing the anti-displacement bracket according to claim 13, characterized in that: The steps of arranging the anti-detachment portion of the bare frame outside the body and connecting the connecting portion of the bare frame to the body include: The anti-slip portion is sleeved on the cup mouth section of the main body; the connecting portion and the end of the cup mouth section are simultaneously connected to the middle section of the main body using a first connecting line; and the connecting portion and the area from the connecting portion to the middle section are coated.

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