Lumen stent and manufacturing method therefor

Abstract

A lumen stent and a manufacturing method therefor. The lumen stent comprises a spiral tube (10) and a colloid layer (20). The colloid layer (20) is arranged around a central axis A of the spiral tube (10). The spiral tube (10) is fixedly connected to the colloid layer (20). The spiral tube (10) is configured to increase a bending radius under the action of an external force, and the colloid layer (20) is configured to expand when the spiral tube (10) increases the bending radius. The spiral tube (10) is configured to be filled with a substance to be cured (30), and the substance to be cured (30) is configured to be cured under a preset condition.

Description

Cavity stent and manufacturing method thereof

[0001] This application claims priority to Chinese patent application No. 202311615856.5 filed on November 28, 2023, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the technical field of medical devices, and in particular to a cavity stent and a manufacturing method thereof. Background Art

[0003] Stent implantation is currently an important clinical method to quickly relieve luminal stenosis and maintain luminal integrity. At this time, luminal stents are needed to support natural cavities of the human body or animals such as the trachea, esophagus, bile duct or urethra.

[0004] Some luminal stents use barrel-shaped stents, but the size of barrel-shaped stents is difficult to adjust, lacks adaptability to the internal structure of the cavity, and is prone to causing poor gas and liquid circulation during use due to its thick wall. The barrel-shaped stent is also prone to hindering the ciliary movement and mucus exchange of the inner wall of the cavity within the stent coverage area; some luminal stents are made of metal into mesh stents, but the metal may form a relatively large extrusion pressure, which can easily induce the growth of epithelial tissue in the natural cavity to form granulation tissue, increase the difficulty of stent removal and the intraoperative risk, and easily induce secondary injuries such as inflammatory reactions and bleeding.

[0005] The above two types of cavity stents have insufficient structural adaptability, and the stents are structurally uniform and difficult to deform in a structurally adaptive manner. Technical issues

[0006] The main purpose of this application is to provide a cavity stent to facilitate structural adaptive deformation. Technical Solutions

[0007] To achieve the above-mentioned purpose, the cavity stent proposed in the present application includes a spiral tube and a colloid layer, the colloid layer is arranged around the axis of the spiral tube, and the spiral tube is fixedly connected to the colloid layer; the spiral tube is used to increase the bending radius under the action of external force, and the colloid layer is used to expand when the bending radius of the spiral tube increases; the spiral tube is used to be filled with a substance to be solidified, and the substance to be solidified is used to solidify under preset conditions.

[0008] In one embodiment, the colloid layer is configured as a hydrogel layer; and / or, a filling drug with a preset function is provided in the colloid layer, and when the cavity stent is installed in a natural cavity of a human body or an animal, the filling drug is used to be released outward from the colloid layer.

[0009] In one embodiment, the filling drug includes at least one of a preset hemostatic drug and a preset anti-inflammatory drug.

[0010] In one embodiment, plugs are respectively provided at both ends of the spiral tube, and the plugs are used to seal the substance to be solidified in the spiral tube.

[0011] In one embodiment, the spiral tube is made of a biocompatible polymer; and / or the colloid layer is configured as a gel layer.

[0012] The present application also proposes a manufacturing method for manufacturing the above-mentioned luminal stent, comprising the following steps:

[0013] immersing at least a portion of the spiral tube in the gel solution;

[0014] The spiral tube is pulled upward at least once to form the colloid layer.

[0015] In one embodiment, before the step of immersing at least a portion of the spiral tube in the gel solution, the manufacturing method further comprises the following steps:

[0016] The spiral tube is sleeved on the rod, and at least a portion of the spiral tube sleeved on the rod is used to be immersed in the gel solution.

[0017] In one embodiment, after the step of pulling the spiral tube upward at least once to form the colloid layer, the manufacturing method further comprises the following steps:

[0018] The colloid layer is allowed to dry and set.

[0019] In one embodiment, after the step of drying and shaping the colloid layer, the manufacturing method further comprises the following steps:

[0020] placing the dried and shaped colloid layer into a liquid so that the colloid layer is in a gel state;

[0021] extracting the rod from the gel-like colloid layer; and / or,

[0022] The step of immersing at least a portion of the spiral tube in the gel solution comprises:

[0023] When the spiral tube is immersed in the gel solution, the angle between the axis of the spiral tube and the liquid surface of the gel solution is greater than or equal to 70 degrees and less than or equal to 90 degrees; and / or

[0024] The step of pulling the spiral tube upward at least once to form the colloid layer comprises:

[0025] When the spiral tube is pulled upward, the angle between the axis of the spiral tube and the liquid surface of the gel solution is greater than or equal to 70 degrees and less than or equal to 90 degrees.

[0026] In one embodiment, the manufacturing method further comprises the following steps: adding a filler drug with a preset function to the gel solution; and / or, the manufacturing method further comprises the following steps: adding a substance to be solidified into the spiral tube; and / or,

[0027] The manufacturing method further comprises the following steps:

[0028] Winding the pipe on the spiral groove of the outer peripheral wall of the cylindrical mold;

[0029] shaping the tube to form the spiral tube;

[0030] The spiral tube is unscrewed out of the cylindrical mold. Beneficial effects

[0031] The technical solution of the present application is to configure the luminal stent to include a spiral tube and a colloid layer, the colloid layer is arranged around the axis of the spiral tube, and the spiral tube is fixedly connected to the colloid layer; the spiral tube is used to increase the bending radius under the action of external force, and the colloid layer is used to expand when the bending radius of the spiral tube increases; the spiral tube is used to be filled with a substance to be solidified, and the substance to be solidified is used to solidify under preset conditions; the luminal stent can be carried on a balloon with a variable diameter and delivered to the diseased cavity in a state of smaller diameter, and then the balloon is inflated to provide external force, so that the diameter of the spiral tube and the luminal stent becomes larger, thereby adapting to the inner wall shape of the natural cavity and allowing the colloid layer to stick to the inner wall of the natural cavity and provide a certain support; in addition, the colloid layer not supported by the spiral tube has a certain elasticity and can form a certain gap with the inner wall of the natural cavity, which is beneficial to the movement of cilia on the inner wall of the natural cavity and the liquid on the inner wall of the cavity can be exchanged and flow along the gap. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0033] FIG1 is a schematic diagram of a main view of an embodiment of a cavity stent of the present application;

[0034] FIG2 is a partial cross-sectional schematic diagram of an embodiment of the lumen stent of the present application;

[0035] FIG3 is a schematic structural diagram of a spiral tube in one embodiment of the luminal stent of the present application;

[0036] FIG4 is a cross-sectional view of a spiral tube in an embodiment of a lumen stent of the present application;

[0037] FIG5 is a schematic diagram of the use process of an embodiment of the luminal stent of the present application;

[0038] FIG6 is a schematic diagram of an embodiment of the cavity stent of the present application in another state as viewed from the main direction;

[0039] FIG7 is a partial cross-sectional schematic diagram of an embodiment of the luminal stent of the present application in another state;

[0040] FIG8 is a schematic structural diagram of the spiral tube in another state in one embodiment of the luminal stent of the present application;

[0041] FIG9 is a schematic diagram of a process flow in one embodiment of the manufacturing method of the present application;

[0042] FIG10 is a schematic diagram of forming a spiral tube in one embodiment of the manufacturing method of the present application;

[0043] FIG. 11 is an exploded view of a spiral tube formed in an embodiment of the manufacturing method of the present application.

[0044] Description of Figure Numbers:

[0045] Reference number name Reference number name 10 spiral tube 20 colloid layer 30 filling with material to be solidified 40 air bag 50 cylindrical mold 51 spiral groove

[0046] The realization of the objectives, functional features and advantages of this application will be further explained in conjunction with embodiments and with reference to the accompanying drawings. Modes for Carrying Out the Invention

[0047] The following will be combined with the accompanying drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of this application.

[0048] It should be noted that if the embodiments of the present application involve directional indications (such as up, down, left, right, front, back, etc.), such directional indications are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0049] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present application, the descriptions of "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or suggesting their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features limited to "first" and "second" may explicitly or implicitly include at least one of such features. In addition, if "and / or" or "and / or" appears in the full text, its meaning includes three parallel schemes. Taking "A and / or B" as an example, it includes scheme A, or scheme B, or a scheme in which A and B are satisfied at the same time. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement it. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by this application.

[0050] Stent implantation is currently an important clinical method to quickly relieve luminal stenosis and maintain luminal integrity. At this time, luminal stents are needed to support natural cavities of the human body or animals such as the trachea, esophagus, bile duct or urethra.

[0051] Some luminal stents are barrel-shaped, but they are difficult to resize and lack adaptability to the internal structure of the lumen. Their thick walls can easily cause poor gas and liquid flow during use. The barrel-shaped stents also tend to hinder ciliary movement and mucus exchange on the lumen's inner wall within the stent's coverage area. Some luminal stents are made of metal mesh, but this metal can create excessive squeezing pressure, easily inducing natural epithelial tissue growth and granulation formation within the lumen. This increases the difficulty of stent removal and the intraoperative risk, and can easily trigger secondary injuries such as inflammatory reactions and bleeding. The above two types of luminal stents lack structural adaptability, and the stents are structurally uniform, making them difficult to adapt to structural deformation.

[0052] Therefore, the present application proposes a cavity stent to facilitate structural adaptive deformation.

[0053] Referring to Figures 1 and 2, in one embodiment of the present application, the luminal stent includes a spiral tube 10 and a colloidal layer 20. The spiral tube 10 can be understood as a pipe wound into a spiral shape. The spiral tube 10 can be in the shape of a tube as shown in the accompanying drawings, or in the shape of a cone shell or a reducer as a whole. This embodiment is not limited to this. The colloidal layer 20 is arranged around the axis A of the spiral tube 10, including the colloidal layer 20 surrounding the axis A of the spiral tube 10 for a full circle, or the colloidal layer 20 surrounding the axis A of the spiral tube 10 The corresponding central angle is less than 360 degrees. This embodiment is not limited to this. The spiral tube 10 is fixedly connected to the colloidal layer 20, for example, the colloidal layer 20 is wrapped around or attached to the spiral tube 10, or the colloidal layer 20 is fixedly connected to the spiral tube 10 by bonding or other methods. When manufactured and unused, the luminal stent has a diameter D10 as shown in the accompanying drawings.

[0054] Referring to Figures 3 and 4 , the spiral tube 10 is filled with a substance to be cured 30, which is intended to be cured under preset conditions. The substance to be cured 30 can be a colloid or fluid to be cured. For example, the colloid to be cured 30 can be made of ultraviolet light-sensitive adhesive or near-infrared light-sensitive adhesive, which is designed to be cured by light-induced curing. Alternatively, the substance to be cured 30 can be a substance that cures through physical means such as heat or magnetism, although this embodiment is not limited thereto.

[0055] It is understandable that, with reference to FIG3 , the substance to be solidified 30 in the spiral tube 10 is solidified only when the bending radius R11 of the spiral tube 10 changes to match the natural cavity of the human body or the natural cavity of an animal. With reference to FIG5 , in one usage scenario, the spiral tube 10 is used to increase the bending radius under the action of an external force, for example, to increase the bending radius when the airbag 40 on the inside is expanded, that is, to increase the external force by expanding the airbag 40 on the inside of the spiral tube 10. The colloid layer 20 has a certain elasticity and can be used to expand when the bending radius of the spiral tube 10 is increased. It is understandable that an entry channel can be provided inside the airbag 40, and the entry channel is used for a curing device to enter, and the curing device is used to cure the above-mentioned substance to be solidified 30.

[0056] 6, 7 and 8, after the inner balloon 40 is expanded, the bending radius of the spiral tube 10 increases from R11 in FIG. 3 to R12 in FIG. 8, and the diameter of the luminal stent increases from D10 to D20 in the figure.

[0057] In this embodiment, the cavity stent can be carried on a balloon 40 with a variable diameter and delivered to the diseased cavity in a smaller diameter state. The balloon 40 is then inflated to provide external force to increase the diameter of the spiral tube 10 and the cavity stent, thereby adapting to the shape of the inner wall of the natural cavity and allowing the colloidal layer 20 to stick to the inner wall of the natural cavity and provide a certain support; in addition, the colloidal layer 20 not supported by the spiral tube 10 has a certain elasticity and can form a certain gap with the inner wall of the natural cavity, which is beneficial to the movement of cilia on the inner wall of the natural cavity and the liquid on the inner wall of the cavity can be exchanged and flow along the gap.

[0058] In some embodiments, the spiral tube 10 can be made of a biocompatible polymer, thereby improving the biocompatibility of the luminal stent with the natural luminal duct of the human body or the natural luminal duct of an animal, and improving the applicability of the luminal stent.

[0059] In some embodiments, the colloid layer 20 can be configured as a gel layer; more specifically, the colloid layer 20 can be configured as a hydrogel layer. Configuring the colloid layer 20 as a gel layer or a hydrogel layer allows the colloid layer 20 to swell but not dissolve under the action of the liquid in the inner wall of a natural human or animal cavity. The colloid layer 20 can form a larger gap with the inner wall of the natural cavity, which is more conducive to the movement of cilia on the inner wall of the natural cavity and allows the liquid in the inner wall of the cavity to exchange and flow along the gap.

[0060] In some embodiments, the colloid layer 20 is provided with a filling drug with a preset function. When the cavity stent is installed in the natural cavity of the human body or the natural cavity of an animal, the filling drug is used to be released outward from the colloid layer 20. The colloid layer 20 can be set as a gel layer or a hydrogel layer, so that the above-mentioned filling drug can be filled in the grid formed by the network chain of the gel layer or the hydrogel layer; when the gel layer or the hydrogel layer swells under the action of the liquid on the inner wall of the natural cavity of the human body or the natural cavity of an animal, the filling drug is used to be released outward from the colloid layer 20, for example, from the grid formed by the above-mentioned network chain. In this embodiment, the colloid layer 20 can support the inner wall of the natural cavity of the human body or the natural cavity of an animal while also carrying the filling drug with a preset function, thereby having better customization performance.

[0061] In some embodiments, the filling drug includes at least one of a preset hemostatic drug and a preset anti-inflammatory drug. For example, the filling drug is set to mometasone conate, dexamethasone and budesonide, etc., so as to deal with bleeding or inflammation symptoms that may occur on the inner wall of the natural cavity of the human body or the natural cavity of an animal after cavity surgery.

[0062] In some embodiments, plugs are provided at both ends of the spiral tube 10 to seal the substance to be solidified 30 within the spiral tube 10. The plugs can be configured as plugs, adhesive blocks, or adhesive tape, and can also be made of a biocompatible material, which is not limited in this embodiment. In this embodiment, the plugs provided at both ends of the spiral tube 10 can reduce the risk of leakage of the substance to be solidified 30 from the spiral tube 10, simplify the preparation process of the spiral tube 10, and reduce the component cost of the spiral tube 10.

[0063] The present application also proposes a manufacturing method for manufacturing the above-mentioned cavity stent. Referring to FIG9 , the manufacturing method comprises the following steps:

[0064] Step S100, immersing at least a portion of the spiral tube 10 in a gel solution; wherein the solution base of the gel solution can be selected from carboxymethyl chitosan, carboxymethyl chitosan, carboxymethyl dextran, sodium carboxymethyl cellulose, oxidized regenerated cellulose, collagen, gelatin, sodium alginate, sodium hyaluronate, and the like, and this embodiment is not limited thereto;

[0065] In step S200 , the spiral tube 10 is pulled upward at least once to form a colloid layer 20 .

[0066] In this embodiment, by pulling up the spiral tube 10 at least partially immersed in the gel solution at least once, the gel solution can adhere to the spiral tube 10 serving as a skeleton and form the above-mentioned colloidal layer 20, thereby improving the manufacturing convenience of the luminal stent.

[0067] When manufacturing the above-mentioned luminal stent using the above-mentioned manufacturing method, when the pitch of the spiral tube 10 is small, the success rate of the gel solution adhering to the spiral tube 10 is high; when the pitch of the spiral tube 10 is large, the success rate of the gel solution adhering to the spiral tube 10 is low. Therefore, in some embodiments, before the step of immersing at least a portion of the spiral tube 10 in the gel solution, the manufacturing method further includes the following steps:

[0068] The spiral tube 10 is sleeved on the rod, and at least a portion of the spiral tube 10 sleeved on the rod is used to be immersed in the gel solution.

[0069] In this embodiment, by sleeve-mounting the spiral tube 10 on the rod, the gel solution can be attached through the outside of the rod and the spiral tube 10 , which is beneficial to improving the success rate of the gel solution's attachment.

[0070] In some embodiments, the roughness of the outer surface of the rod can be set to be less than or equal to a preset roughness to facilitate subsequent extraction of the rod from the colloid layer 20. For example, the rod can be a ceramic rod. It is understood that the diameter of the rod can be set to match the bending diameter of the inner side of the spiral tube 10. For example, the difference between the diameter of the rod and the bending diameter of the inner side of the spiral tube 10 is less than or equal to a preset tolerance value.

[0071] In some embodiments, the step of submerging at least a portion of the spiral tube 10 in the gel solution may include:

[0072] When the spiral tube 10 is immersed in the gel solution, the angle between the axis of the spiral tube 10 and the liquid surface of the gel solution is greater than or equal to 70 degrees and less than or equal to 90 degrees. For example, the angle between the axis of the spiral tube 10 and the liquid surface of the gel solution is greater than or equal to 80 degrees and less than or equal to 90 degrees, or the angle between the axis of the spiral tube 10 and the liquid surface of the gel solution is greater than or equal to 85 degrees and less than or equal to 90 degrees. It can be understood that the spiral tube 10 is inserted vertically into the gel solution as a whole to further improve the success rate of gel solution adhesion.

[0073] Of course, the step of pulling the spiral tube 10 upward at least once to form the colloid layer 20 may also be set to include:

[0074] When the spiral tube 10 is pulled upward, the angle between the axis of the spiral tube 10 and the liquid surface of the gel solution is greater than or equal to 70 degrees and less than or equal to 90 degrees; for example, the angle between the axis of the spiral tube 10 and the liquid surface of the gel solution is greater than or equal to 80 degrees and less than or equal to 90 degrees, or the angle between the axis of the spiral tube 10 and the liquid surface of the gel solution is greater than or equal to 85 degrees and less than or equal to 90 degrees. It can be understood that the spiral tube 10 as a whole is vertically separated from the gel solution to further improve the success rate of gel solution adhesion.

[0075] In some embodiments, after the step of pulling the spiral tube 10 upward at least once to form the colloid layer 20, the manufacturing method further comprises the following steps:

[0076] The colloid layer 20 is dried and shaped, for example, by oven drying or air drying, so as to improve the adhesion stability of the colloid layer 20 on the spiral tube 10 .

[0077] In some embodiments, after the step of drying and setting the colloid layer 20, the manufacturing method further comprises the following steps:

[0078] The dried and shaped colloid layer 20 is placed in a liquid, such as water, so that the colloid layer 20 is in a gel state;

[0079] The rod is pulled out from the gel-like colloid layer 20 .

[0080] In this embodiment, after the dried and shaped colloid layer 20 is placed in a liquid and becomes gel-like, the colloid layer 20 becomes less tightly attached to the rod, which helps to improve the smoothness of the rod extraction. In addition, placing the colloid layer 20 in the liquid after drying and shaping it helps reduce the risk of dissolution of the structure of the colloid layer 20.

[0081] In some embodiments, the manufacturing method further includes the following steps: adding a filling drug with a preset function to the gel solution, such as adding at least one of a preset hemostatic drug and a preset anti-inflammatory drug, such as adding mometasone conate, dexamethasone and budesonide, so that while forming the colloidal layer 20, the colloidal layer 20 carries the filling drug with a preset function, such as carrying a drug that can cope with bleeding or inflammatory symptoms, thereby improving the customization efficiency of the colloidal layer 20.

[0082] In some embodiments, the manufacturing method further comprises the step of adding a substance to be cured 30 into the spiral tube 10 to facilitate subsequent fixing of the size of the spiral tube 10 and the luminal stent. In some embodiments, the step of adding the substance to be cured 30 into the spiral tube 10 is performed after the step of pulling the spiral tube 10 upward at least once to form the colloid layer 20, or after the step of drying and setting the colloid layer 20, or after the step of extracting the rod from the gel-like colloid layer 20, to reduce the risk of accidental curing of the substance to be cured 30.

[0083] After the step of adding the substance to be solidified 30 into the spiral tube 10 , the cavity stent can be stored away from light to further reduce the risk of accidental solidification of the substance to be solidified 30 .

[0084] In some embodiments, referring to FIG. 10 and FIG. 11 , the manufacturing method further includes the following steps:

[0085] The tubing is wound around the spiral groove 51 on the outer circumferential wall of the cylindrical mold 50. Specifically, the tubing can be wound around the outer circumferential wall of the cylindrical mold 50 along the direction of the spiral groove 51. The dimensions of the cylindrical mold 50 and the spiral groove 51 can be determined according to pre-set clinical requirements.

[0086] The tube material is shaped to form a spiral tube 10; wherein, the spiral tube 10 formed by winding can be fixed and then placed in a baking oven for thermoforming, etc., to form the spiral tube 10; wherein, when placing in the baking oven for thermoforming, the baking temperature and baking time can be determined according to the material of the spiral tube 10;

[0087] The spiral tube 10 is unscrewed out of the cylindrical mold 50 , thereby being separated from the cylindrical mold 50 .

[0088] In this embodiment, the manufacturing method can improve the flexibility of the size of the customized spiral tube 10 through the cylindrical mold 50 and the spiral groove 51; it can be understood that the size of the cylindrical mold 50 and the spiral groove 51 can be flexibly designed, thereby improving the flexibility of the size of the customized spiral tube 10.

[0089] It is understandable that, since the present manufacturing method adopts all the technical solutions of all the embodiments of the above-mentioned cavity stent, it has at least all the beneficial effects brought about by the technical solutions of the above-mentioned embodiments, which will not be described one by one here.

[0090] The above description is merely an optional embodiment of the present application and does not limit the patent scope of the present application. Any equivalent structural transformation made by using the contents of the present application specification and drawings under the technical concept of the present application, or directly / indirectly applied in other related technical fields, is included in the patent protection scope of the present application.

Claims

1. A lumen stent, wherein, the lumen stent includes a spiral tube and a colloid layer. The colloid layer is arranged around the axis line of the spiral tube, and the spiral tube is fixedly connected to the colloid layer; the spiral tube is used to increase the bending radius under an external force, and the colloid layer is used to expand when the spiral tube increases the bending radius; the inside of the spiral tube is used to fill a substance to be cured, and the substance to be cured is used to cure under preset conditions.

2. The lumen stent according to claim 1, wherein, the colloid layer is arranged as a hydrogel layer; and / or, the colloid layer is provided with a filling drug having a preset function, and when the lumen stent is installed in a natural lumen of a human body or a natural lumen of an animal, the filling drug is used to be released outward from the colloid layer.

3. The lumen stent according to claim 2, wherein, the filling drug includes at least one of a preset hemostatic drug and a preset anti-inflammatory drug.

4. The lumen stent according to any one of claims 1 to 3, wherein, plug heads are respectively arranged at both ends of the spiral tube, and the plug heads are used to block the substance to be cured in the spiral tube.

5. The lumen stent according to claim 1, wherein, the spiral tube is made of a biocompatible polymer; and / or, the colloid layer is arranged as a gel layer.

6. A manufacturing method, wherein, the manufacturing method is used to manufacture the lumen stent according to any one of claims 1 to 5, and the manufacturing method includes the following steps: Immerse at least part of the spiral tube in a gel solution; Lift the spiral tube upward at least once to form the colloid layer.

7. The manufacturing method according to claim 6, wherein, before the step of immersing at least part of the spiral tube in the gel solution, the manufacturing method further includes the following steps: Sheathe the spiral tube on a rod, and at least part of the spiral tube sheathed on the rod is used to be immersed in the gel solution.

8. The manufacturing method according to claim 7, wherein, after the step of lifting the spiral tube upward at least once to form the colloid layer, the manufacturing method further includes the following steps: Dry and shape the colloid layer.

9. The manufacturing method according to claim 8, wherein, after the step of drying and shaping the colloid layer, the manufacturing method further includes the following steps: Put the dried and shaped colloid layer into a liquid to make the colloid layer in a gel state; Extract the rod from the gel-like colloid layer; and / or, The step of immersing at least part of the spiral tube in the gel solution includes: When immersing the spiral tube in the gel solution, make the angle between the axis line of the spiral tube and the liquid surface of the gel solution greater than or equal to 70 degrees and less than or equal to 90 degrees; and / or, The step of lifting the spiral tube upward at least once to form the colloid layer includes: When lifting the spiral tube upward, make the angle between the axis line of the spiral tube and the liquid surface of the gel solution greater than or equal to 70 degrees and less than or equal to 90 degrees.

10. The manufacturing method according to claim 6, wherein, The manufacturing method further includes the following steps: adding a filling drug with a preset function to the gel solution; and / or, the manufacturing method further includes the following steps: adding a substance to be cured into the spiral tube; and / or, The manufacturing method further includes the following steps: winding the pipe around the spiral groove on the outer peripheral wall of the cylindrical mold; shaping the pipe to form the spiral tube; unscrewing the spiral tube from the cylindrical mold.

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