Bracket weaving tooling, bracket weaving and forming method, and bracket

Abstract

The present application discloses a stent weaving tooling, a stent weaving and forming method, and a stent, belonging to the technical field of medical devices. The stent weaving tooling includes a main body and wire winding columns. The wire winding columns are arranged around the surface of the main body for the silk thread to be wound and woven, and the intervals between the wire winding columns are the same or different. The stent weaving and forming method is completed relying on the stent weaving tooling. The silk thread is woven through the wire winding columns. The silk thread forms inflection points of the silk thread after passing through the wire winding columns, and is wound multiple times to become the shaping support points of the stent, playing a supporting role in the overall shape of the stent; by changing the diameter of the main body, the distance between rows of wire winding columns, the distance between roots of wire winding columns in each row, and the silk thread winding method, the overall shape of the stent formed later can be adjusted; local treatment, heat setting, and rapid cooling treatment are carried out on the preliminarily formed stent, improving the self-supporting strength of the stent; the radial supporting force and the supporting time of the formed stent are greatly improved, and the stent is more easily fixed in the nasal cavity body.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to a stent weaving tooling, a stent weaving and forming method, and a stent. Background Art

[0002] Chronic rhinosinustis (CRS) nasal polyps are chronic inflammatory diseases of the nasal cavity and sinus mucosa, and even involve the nasal cavity and sinus bones. The incidence of sinusitis and allergic rhinitis is high, the infected population is wide, and it is difficult to cure. The incidence of allergic sinusitis is as high as 10-14%. The most commonly used and effective surgical method at present is functional endoscopic sinus surgery (FESS). Through minimally invasive surgery, the lesions are removed, the blocked sinus openings are opened, and the physiological functions of the nasal cavity are restored and reconstructed. However, due to nasal cavity adhesion after FESS, the sinus openings are re-closed, and the nasal mucosa cannot be sutured and hemostatic after the operation. Substances such as expanded sponges need to be filled to compress and stop bleeding.

[0003] Currently, the existing stent styles are mainly cylindrical stents. The existing stent weaving methods and shapes are described in patents (WO2017206155, CN101945621B): The stent weaving forms disclosed in the above patents present a cylindrical style, woven into a mesh structure (or diamond style), and have a certain adaptability to the nasal cavity space. Although different styles of stents can also be selected according to different structures inside the nasal cavity, the stents in the above patents are only fixed to the sinuses in the form of endpoints at the endpoints, and the middle position adheres to the inner side of the sinuses by the silk threads of the stent, and it is easy to slide and shift in the sinuses due to insufficient support points. Although the stents described in the above patents have a certain radial force, in the actual clinical application process, they show insufficient radial force and cannot maintain the support of a certain radial force for a long time. Summary of the Invention

[0004] In view of the above problems, the present invention provides a stent weaving tooling and a stent weaving and forming method, which add fixing points in the middle of the stent. On the one hand, it increases the support points with the inner wall of the cavity in the sinuses, preventing the displacement and detachment of the stent; on the other hand, it also increases the overall radial force of the stent, maximally expanding the volume of the cavity formed by the stent support and prolonging the support time of the stent.

[0005] The technical solution adopted by the present invention is as follows: A stent weaving tooling, characterized in that it includes a main body and a plurality of wire winding columns, the wire winding columns are arranged around the surface of the main body for winding and weaving silk threads, and the intervals between the wire winding columns are the same or different.

[0006] A stent weaving and forming method, characterized in that it is woven and formed by using the above stent weaving tooling, and includes the following steps:

[0007] Step 1: The winding posts include an initial winding post and a braided winding post. Fix the silk thread on the initial winding post, and then wind it around the braided winding post of the tooling in sequence, winding one week along the surface of the tooling. The silk thread is made of degradable material or non-degradable material.

[0008] Step 2: When performing the second week of braiding, the winding path of the silk thread is geometrically complementary to that of the first week.

[0009] Step 3: When performing a new week of braiding each time, the winding path of the silk thread is geometrically complementary to that of the previous week. Repeat this cycle to complete the preliminary braiding and form a preliminarily shaped bracket.

[0010] Step 4: Locally connect and fix the preliminarily shaped bracket, and perform connection and fixation treatment on the parts of initial braiding, end braiding, and silk thread crossing.

[0011] Step 5: Heat-treat the bracket after local connection and fixation treatment to complete the heat setting of the bracket.

[0012] Step 6: Rapidly cool down the bracket that has completed heat setting at a low temperature to complete the entire braiding and setting of the bracket.

[0013] Further, the winding posts include an initial winding post and a braided winding post. The braided winding post includes four rows of winding posts arranged in parallel, which are area A, area B, area C, and area D in sequence. The number and spacing of the winding posts in area A and area D are the same and are aligned up and down. The number and spacing of the winding posts in area B and area C are the same and are aligned up and down.

[0014] Further, the first week of braiding is carried out in a counterclockwise or clockwise winding manner in the path of a "V" shape, and the second week of braiding is carried out in a complementary braiding manner of a geometric configuration according to the first week of braiding manner.

[0015] Further, in Step 1, when the number of winding posts in area A and area D is 3n respectively, and the number of winding posts in area B and area C is n respectively, or when the number of winding posts in area A and area D is 3n + 1 respectively, and the number of winding posts in area B and area C is n respectively, or when the number of winding posts in area A and area D is 3n + 2 respectively, and the number of winding posts in area B and area C is n + 1 respectively, the winding manner of the silk thread is wound in the path of a "big W", where n is an integer from 1 to 15.

[0016] Further, in Step 1, when the number of winding posts in Area A and Area D is 4n respectively, and the number of winding posts in Area B and Area C is 2n respectively; or when the number of winding posts in Area A and Area D is 4n + 1 respectively, and the number of winding posts in Area B and Area C is 2n respectively; or when the number of winding posts in Area A and Area D is 4n + 2 respectively, and the number of winding posts in Area B and Area C is 2n + 1 respectively; or when the number of winding posts in Area A and Area D is 4n + 3 respectively, and the number of winding posts in Area B and Area C is 2n + 1 respectively, the silk thread is wound in the "big W, small v" path mode, where n is an integer from 1 to 15.

[0017] Further, in Step 1, when the number of winding posts in Area A and Area D is 5n respectively, and the number of winding posts in Area B and Area C is n respectively; or when the number of winding posts in Area A and Area D is 5n + 1 respectively, and the number of winding posts in Area B and Area C is n respectively; or when the number of winding posts in Area A and Area D is 5n + 2 respectively, and the number of winding posts in Area B and Area C is n + 1 respectively; or when the number of winding posts in Area A and Area D is 5n + 3 respectively, and the number of winding posts in Area B and Area C is n + 1 respectively; or when the number of winding posts in Area A and Area D is 5n + 4 respectively, and the number of winding posts in Area B and Area C is n + 1 respectively, the silk thread is wound in the "big W, big V" path mode, where n is an integer from 1 to 15.

[0018] Further, the braided winding posts further include winding posts in Area E and Area F arranged in parallel, and the number of winding posts in Area E and Area F is equal and they are aligned vertically. Area E is arranged between Area A and Area B, and Area F is arranged between Area C and Area D, where the distances between Area A and Area E, Area E and Area B, Area C and Area F, and Area F and Area D are equal.

[0019] Further, in Step 4, the connection and fixation treatment is a combination of one or more of mechanical structure connection, welding, and bonding.

[0020] A bracket is made by any of the above bracket braiding and forming methods.

[0021] The beneficial effects of the present invention are as follows: The silk thread is braided through the winding posts, and the winding posts are arranged around the surface of the main body, enabling the silk thread to wind back and forth along the surface of the main body during the braiding process. The part of the silk thread passing through the winding posts becomes the inflection point of the silk thread, and due to multiple windings, it finally becomes the shaping support point of the bracket, playing a supporting role in the overall shape of the bracket and enabling the bracket to adapt to the internal structure of the nasal sinus; by changing the diameter of the main body, the distance between rows of winding posts, the distance between roots of each row of winding posts, and the winding mode of the silk thread, the overall shape of the formed bracket can be adjusted later; local treatment, heat setting, and rapid cooling treatment are performed on the preliminarily formed bracket, improving the self-supporting strength of the bracket; the radial supporting force and supporting time of the formed bracket are greatly improved, and the bracket is more easily fixed in the nasal cavity. Brief Description of the Drawings

[0022] Figure 1 is a schematic diagram of the overall structure of the tooling according to an embodiment of the present invention;

[0023] Figure 2 is an exploded structure schematic diagram according to an embodiment of the present invention;

[0024] Figure 3 is a schematic diagram of the central axis structure according to an embodiment of the present invention;

[0025] Figure 4 is a schematic diagram of the upper main body structure according to an embodiment of the present invention;

[0026] Figure 5 is a schematic diagram of the fully-sectioned structure of the upper main body according to an embodiment of the present invention;

[0027] Figure 6 is a schematic diagram of the lower main body structure according to an embodiment of the present invention;

[0028] Figure 7 is a schematic diagram of the fully-sectioned structure of the lower main body according to an embodiment of the present invention;

[0029] Figure 8 is a schematic diagram of the arrangement of the winding posts according to an embodiment of the present invention;

[0030] Figure 9 is a schematic diagram of the arrangement of the winding posts according to another embodiment of the present invention;

[0031] Figure 10 is a schematic diagram of the arrangement of the winding posts according to yet another embodiment of the present invention;

[0032] Figure 11 is a schematic diagram of the arrangement of the winding posts according to still another embodiment of the present invention;

[0033] Figure 12 is a schematic diagram of the arrangement of the winding posts according to another embodiment of the present invention;

[0034] Figure 13 is a schematic diagram of the drug stent woven according to the present invention;

[0035] Figure 14 is an arrangement diagram of the winding post area of the braiding tooling CT1 according to an embodiment of the present invention;

[0036] Figure 15 is an example diagram of the braiding method of the braiding tooling CT1 according to an embodiment of the present invention;

[0037] Figure 16 is an unfolded diagram of the stent formed by the braiding tooling CT1 according to an embodiment of the present invention;

[0038] Figure 17 Two positions and winding forms of the initial winding post O of the knitting tooling CT1 according to an embodiment of the present invention;

[0039] Figure 18a Scheme of the silk thread bypassing the winding post according to an embodiment of the present invention;

[0040] Figure 18b Schematic diagram of the vertex of the support where the silk thread bypasses the winding post according to an embodiment of the present invention;

[0041] Figure 19a Front view scheme of the silk thread bypassing the winding post and winding around one circle inside according to an embodiment of the present invention;

[0042] Figure 19b Schematic diagram of the vertex of the support in the front view of the silk thread bypassing the winding post and winding around one circle inside according to an embodiment of the present invention;

[0043] Figure 20a Side view scheme of the silk thread bypassing the winding post and winding around one circle inside according to an embodiment of the present invention;

[0044] Figure 20b Schematic diagram of the vertex of the support in the side view of the silk thread bypassing the winding post and winding around one circle inside according to an embodiment of the present invention;

[0045] Figure 21a Front view scheme of the silk thread bypassing the winding post and winding around one circle outside according to an embodiment of the present invention;

[0046] Figure 21b Schematic diagram of the vertex of the support in the front view of the silk thread bypassing the winding post and winding around one circle outside according to an embodiment of the present invention;

[0047] Figure 22a Side view scheme of the silk thread bypassing the winding post and winding around one circle outside according to an embodiment of the present invention;

[0048] Figure 22b Schematic diagram of the vertex of the support in the side view of the silk thread bypassing the winding post and winding around one circle outside according to an embodiment of the present invention;

[0049] Figure 23a Scheme of the silk thread bypassing the winding post outside according to an embodiment of the present invention;

[0050] Figure 23b Schematic diagram of the vertex of the support where the silk thread bypasses the winding post outside according to an embodiment of the present invention;

[0051] Figure 24a One form of the processing scheme of the middle winding post according to an embodiment of the present invention;

[0052] Figure 24b Another form of the processing scheme of the middle winding post according to an embodiment of the present invention;

[0053] Figure 24c Another form of the processing solution for the middle winding post in an embodiment of the present invention;

[0054] Figure 24d Another form of the processing solution for the middle winding post in an embodiment of the present invention;

[0055] Figure 24e Another form of the processing solution for the middle winding post in an embodiment of the present invention;

[0056] Figure 24f Another form of the processing solution for the middle winding post in an embodiment of the present invention;

[0057] Figure 24g Another form of the processing solution for the middle winding post in an embodiment of the present invention;

[0058] Figure 25 One of the processing forms for the starting and ending parts of the bracket weaving in an embodiment of the present invention;

[0059] Figure 26 Arrangement diagram of the winding post area of the weaving tool CT2 in the third embodiment of the present invention;

[0060] Figure 27 Example diagram of the weaving method of the weaving tool CT2 in an embodiment of the present invention;

[0061] Figure 28 Expanded view of the bracket formed by the weaving tool CT2 in an embodiment of the present invention;

[0062] Figure 29a Influence of the diameter D2 of the winding post as an inflection point on the wire path of the bracket;

[0063] Figure 29b Influence of the diameter D3 of the winding post as an inflection point on the wire path of the bracket;

[0064] Figure 30 Arrangement diagram of the winding post area of the weaving tool CT3 in the fourth embodiment of the present invention;

[0065] Figure 31 Example diagram of the weaving method of the weaving tool CT3 in an embodiment of the present invention;

[0066] Figure 32 Expanded view of the bracket formed by the weaving tool CT3 in an embodiment of the present invention;

[0067] Figure 33 Expanded schematic diagram of the bracket woven by the weaving method described in the fifth embodiment of the present invention;

[0068] Figure 34aSchematic diagram of the expansion of the same starting point bracket woven by the weaving method described in Embodiment 6 of the present invention;

[0069] Figure 34b Schematic diagram of the expansion of brackets with different starting points woven by the weaving method described in Embodiment 6 of the present invention;

[0070] Figure 35a Schematic diagram of the expansion of the same starting point bracket woven by the weaving method described in Embodiment 7 of the present invention;

[0071] Figure 35b Schematic diagram of the expansion of brackets with different starting points woven by the weaving method described in Embodiment 7 of the present invention;

[0072] Figure 36a Schematic diagram of the expansion of the same starting point bracket woven by the weaving method described in Embodiment 8 of the present invention;

[0073] Figure 36b Schematic diagram of the expansion of brackets with different starting points woven by the weaving method described in Embodiment 8 of the present invention.

[0074] The reference numerals in the figure are: 1, main body; 11, upper main body; 111, first connection hole; 112, first square hole; 113, first placement groove; 114, first cylinder; 115, second cylinder; 12, lower main body; 121, second connection hole; 122, second square hole; 123, second placement groove; 13, central axis; 131, square cylinder; 132, external thread; 14, fastening nut; 15, spring; 16, slot; 17, ventilation hole; 2, winding column; 21, area A; 22, area B; 23, area C; 24, area D; 25, initial winding column; 26, area E; 27, area F. Detailed implementation manners

[0075] The present invention will be described in detail below with reference to the accompanying drawings.

[0076] Refer to Figure 1 , the bracket weaving tooling includes a main body 1 and a plurality of rows of winding columns 2. The winding columns 2 are arranged around the surface of the main body 1 for winding and weaving silk threads, and the intervals between the winding columns 2 are the same or different.

[0077] The silk thread is woven through the winding post 2. The winding post 2 is arranged around the surface of the main body 1, so that the silk thread can wind back and forth along the surface of the main body 1 during the weaving process. The part of the silk thread passing through the winding post 2 becomes the inflection point of the silk thread, and finally becomes the shaping support point of the stent due to multiple windings, playing a supporting role in the overall shape of the stent, enabling the stent to adapt to the internal structure of the nasal sinus; by changing the diameter of the main body 1, the distance between rows of the winding posts 2, the distance between the roots of each row of winding posts 2, and the winding method of the silk thread, the overall shape of the formed stent can be adjusted later.

[0078] The diameter range of the winding post 2 is 0.2 mm - 3.0 mm, and the diameter of the winding post 2 is 0.5 - 10 times the diameter of the silk thread.

[0079] See Figure 2 , the main body 1 includes an upper main body 11, a lower main body 12, a central axis 13 and a fastening nut 14. The upper main body 11 and the lower main body 12 are connected by the central axis 13. The fastening nut 14 is threadedly connected to the central axis 13 and is respectively arranged on the outer sides of the upper main body 11 and the lower main body 12, and cooperates with the central axis 13 to fix the upper main body 11 and the lower main body 12.

[0080] The main body 1 is made of a stable material that does not undergo physical deformations or chemical changes such as cracking, softening, and volatilization under high temperature or rapid cooling conditions. The material can be, but is not limited to, one or a combination of special glass, ceramics, metals, metal alloys, and polymer materials.

[0081] The main body 1 is cylindrical, drum-shaped or dumbbell-shaped, and the diameter range of the main body 1 is 10 mm - 100 mm.

[0082] A method for braiding and forming a stent, which is braided and formed by using the above-mentioned stent braiding tooling, includes the following steps:

[0083] Step 1: The winding post includes an initial winding post 25 and a braiding winding post. Fix the silk thread on the initial winding post 25, and then wind it around the braiding winding posts of the tooling in sequence, winding one week along the surface of the tooling. The silk thread is made of a degradable material or a non-degradable material;

[0084] Step 2: When performing the second week of braiding, the winding path of the silk thread is geometrically complementary to the winding path of the first week;

[0085] Step 3: When performing a new week of braiding each time, the winding path of the silk thread is geometrically complementary to the winding path of the previous week. Repeat this cycle to complete the preliminary braiding and form a preliminarily formed stent;

[0086] Step 4: Locally connect and fix the preliminarily formed stent, and perform connection and fixation processing on the parts of initial braiding, end braiding, and silk thread crossing;

[0087] Step Five: Heat-treat the stent after local connection and fixation to complete the heat setting of the stent;

[0088] Step Six: Rapidly cool the heat-set stent at low temperature to complete the overall braiding and setting of the stent.

[0089] The material of the silk thread can be polymer filaments, degradable polymer materials, and non-degradable polymer materials mentioned in Patent CN101945621B and Patent WO2017206155, including but not limited to the following materials: polylactic acid, L-polylactic acid, polyglycolide / lactide copolymer, polycaprolactone, polyhydroxybutyrate valerate, polyacetylglutamic acid, polyorthoester, and polyethylene oxide / polybutene copolymer, poly(p-dioxanone), poly(butylene succinate), poly(glycerol sebacate), chitosan, PVA, etc. copolymers or blends, magnesium metal, magnesium alloy, zinc-based alloy, iron, iron-based alloy, tungsten, tungsten-based alloy. The materials involved in the patent can also include the following materials. The non-degradable materials can be polymer materials such as polyurethane, polypropylene, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, acrylic resin, polymethyl methacrylate (PBMA), poly(vinylidene fluoride-hexafluoropropylene) (PVDF-HFP), polyvinylpyrrolidone, etc., and metal materials such as nickel-titanium alloy. The degradable materials can also be copolymers such as poly(propylene carbonate) (PPC), poly(ethylene carbonate) (PEC), poly(propylene ethylene carbonate) (PPEC), poly(β-hydroxybutyric acid) (PHB), poly(ethylene oxide) (PEO), etc., polycaprolactone (PCL) and its modified polymers, polyvinyl alcohol grafted polylactic acid-glycolic acid copolymer (PVA-LGA), phosphocholine polymer, etc. The silk thread needs to be homogeneous, and its surface can be smooth or rough. Different materials and specifications of silk threads can be selected according to factors such as the implantation position, space size, force requirements, and implantation time length. The factors affecting the physical properties of the implanted stent include silk thread material, diameter, braiding method, stent shape, etc. The factors affecting the degradation performance of the stent include silk thread material and silk thread diameter. Preferably, the material of the silk thread can be selected from high molecular materials such as polylactic acid, L-polylactic acid, polyglycolide / lactide copolymer, etc.

[0090] In one embodiment, the braided winding posts include four rows of winding posts arranged in parallel, which are the A area 21, B area 22, C area 23, and D area 24 in sequence. The number and spacing of the winding posts in the A area 21 and D area 24 are the same and they are aligned vertically. The number and spacing of the winding posts in the B area 22 and C area 23 are the same and they are aligned vertically. In other embodiments, there is no limit to the number of rows of the braided winding posts.

[0091] In one embodiment, the first - week braiding method can be carried out in a counter - clockwise or clockwise winding manner along the path of a "V" shape, and the second - week braiding method forms a complementary braiding method for the geometric configuration according to the first - week braiding method.

[0092] In step one, when the number of winding posts in the A area 21 and D area 24 is 3n respectively, and the number of winding posts in the B area 22 and C area 23 is n respectively, or when the number of winding posts in the A area 21 and D area 24 is 3n + 1 respectively, and the number of winding posts in the B area 22 and C area 23 is n respectively, or when the number of winding posts in the A area 21 and D area 24 is 3n + 2 respectively, and the number of winding posts in the B area 22 and C area 23 is n + 1 respectively, the winding method of the silk thread can be selected to wind along the "big W" path, where n is an integer from 1 to 15.

[0093] When the number of winding posts in the A area 21 and D area 24 is 4n respectively, and the number of winding posts in the B area 22 and C area 23 is 2n respectively, or when the number of winding posts in the A area 21 and D area 24 is 4n + 1 respectively, and the number of winding posts in the B area 22 and C area 23 is 2n respectively, or when the number of winding posts in the A area 21 and D area 24 is 4n + 2 respectively, and the number of winding posts in the B area 22 and C area 23 is 2n + 1 respectively, or when the number of winding posts in the A area 21 and D area 24 is 4n + 3 respectively, and the number of winding posts in the B area 22 and C area 23 is 2n + 1 respectively, the winding method of the silk thread can be selected to wind along the "big W small v" path, where n is an integer from 1 to 15.

[0094] When the number of winding posts in the A area 21 and D area 24 is 5n respectively, and the number of winding posts in the B area 22 and C area 23 is n respectively, or when the number of winding posts in the A area 21 and D area 24 is 5n + 1 respectively, and the number of winding posts in the B area 22 and C area 23 is n respectively, or when the number of winding posts in the A area 21 and D area 24 is 5n + 2 respectively, and the number of winding posts in the B area 22 and C area 23 is n + 1 respectively, or when the number of winding posts in the A area 21 and D area 24 is 5n + 3 respectively, and the number of winding posts in the B area 22 and C area 23 is n + 1 respectively, or when the number of winding posts in the A area 21 and D area 24 is 5n + 4 respectively, and the number of winding posts in the B area 22 and C area 23 is n + 1 respectively, the winding method of the silk thread can be selected to wind along the "big W big V" path, where n is an integer from 1 to 15.

[0095] In another embodiment, the braided winding posts further include E-zone and F-zone winding posts arranged in parallel, and the number of winding posts in the E-zone and F-zone is equal and they are aligned vertically. The E-zone is arranged between the A-zone 21 and the B-zone 22, and the F-zone is arranged between the C-zone 23 and the D-zone 24, where the distances between the A-zone 21 and the E-zone, the E-zone and the B-zone 22, the C-zone 23 and the F-zone, and the F-zone and the D-zone 24 are equal.

[0096] In step four, the connection and fixation treatment can use connection and fixation methods that do not damage the overall structure and strength of the stent, and can be one or a combination of methods such as mechanical structure connection, welding, and bonding. Specifically, the mechanical structure connection method can be fastener connection, hinge connection, screw connection, shrink connection, snap connection, etc.; the welding method can be heat welding, ultrasonic welding, vibration welding, resistance welding, induction welding, spot welding, rivet welding, etc., and in suitable cases, the connection method can also be laser welding; for bonding, commercially available implantable medical device glue can be used for bonding, or a polymer material with a lower glass transition temperature can be used for bonding, or solvent bonding or an organic solvent solution of a polymer material can be used for bonding, etc. Preferably, when bonding, the same polymer material or an organic solvent solution of the same polymer material is selected for bonding to reduce other risks brought to the stent by introducing other solutions or materials. Specifically, in Figure 16 For the stent shown, bonding can be selected at the intersection points, and when appropriate, the connection can also be made at the places where the silk threads in the B and C winding post intervals come into contact, which can appropriately reduce the deformation of the stent during compression deformation and enable the operator to better compress the stent.

[0097] In step five, the stent needs to be heat-set. Only after the treatment does the stent have a braided shape and can provide a long-term support effect and a large radial force. Specifically, the temperature selected for stent setting is related to the material of the braided stent. Generally, when the material of the silk thread is a polymer, the heat-setting temperature should be higher than the glass transition temperature of the selected material and lower than the melting temperature of the material. Preferably, heat-setting is carried out at 100°C - 180°C for 5 - 20 minutes. For example, heat-setting is carried out at 160°C for 10 minutes.

[0098] In step six, after the stent is heat-set, the stent needs to be rapidly cooled at a low temperature, similar to the quenching process of metal. The temperature and time of this cooling need to cool the stent to around room temperature in a short time. Preferably, the temperature can be selected to cool from -20°C to -60°C for 3 - 8 minutes. For example, cooling is carried out at -40°C for 5 minutes.

[0099] After the stent is woven and shaped, drugs can be loaded into the interior or on the surface of the stent by physical or chemical methods. Specifically, methods such as coating, dipping, ion exchange, adsorption, etc. can be selected. The drugs include but are not limited to anti-inflammatory drugs, anti-allergic drugs, anticoagulant drugs, antithrombin drugs, immunomodulatory drugs, hemostatic drugs, etc. When coating and dipping the drug coating, the specific drug coating contains drugs, drug-loading substrates, plasticizers, sustained-release agents, etc. The drug-loading substrates can be biodegradable or special materials with micropores, such as poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid) copolymer, chitosan, gelatin, fibrin, medical gel, etc. Ion exchange and adsorption drug loading require chemical means to select to load the drug on the surface or inside of the stent before or after stent weaving.

[0100] Example 1

[0101] See Figure 1 , this embodiment provides a stent weaving tooling, including a main body 1 and several rows of wire winding columns 2. The wire winding columns 2 are arranged around the surface of the main body 1 for the silk thread to wind and weave, and the intervals between the wire winding columns 2 are the same or different.

[0102] The diameter of the wire winding column 2 is 0.4 mm - 1.6 mm, and the diameter of the wire winding column 2 is 0.5 - 10 times the diameter of the silk thread.

[0103] See Figure 2 , the main body 1 includes an upper main body 11, a lower main body 12, a central shaft 13 and a fastening nut 14. The upper main body 11 and the lower main body 12 are connected by the central shaft 13. The fastening nut 14 is threadedly connected to the central shaft 13 and is respectively arranged on the outer sides of the upper main body 11 and the lower main body 12, and cooperates with the central shaft 13 to fix the upper main body 11 and the lower main body 12. The main body 1 includes an upper main body 11, a lower main body 12, a central shaft 13 and a fastening nut 14. The upper main body 11 and the lower main body 12 are connected by the central shaft 13. The fastening nut 14 is threadedly connected to the central shaft 13 and is respectively arranged on the outer sides of the upper main body 11 and the lower main body 12, and cooperates with the central shaft 13 to fix the upper main body 11 and the lower main body 12.

[0104] See Figure 5 , a first connection hole 111 is provided at the center of the upper main body 11, and the first connection hole 111 penetrates through the upper main body 11; a second connection hole 121 is provided at the center of the lower main body 12, and the second connection hole 121 penetrates through the lower main body 12. Both ends of the central shaft 13 respectively pass through the first connection hole 111 and the second connection hole 121 to connect the upper main body 11 and the lower main body 12 together.

[0105] The central axis 13 penetrates through the upper main body 11 and the lower main body 12, restricting the relative positions of the upper main body 11 and the lower main body 12 on the left and right, so that the upper main body 11 and the lower main body 12 are on the same central axis. At the same time, fastening nuts 14 are respectively arranged on the outer sides of both ends of the upper main body 11 and the lower main body 12, and are fastened in cooperation with the threads at both ends of the central axis 13, so that the relative displacement between the upper main body 11 and the lower main body 12 along the direction of the central axis 13 is restricted.

[0106] See Figure 3 , the middle section of the central axis 13 is a square column 131, and external threads 132 are provided at both ends of the central axis 13. Square holes are provided on both the upper main body 11 and the lower main body 12, namely a first square hole 112 and a second square hole 122 respectively. The upper main body 11 and the lower main body 12 are respectively positioned with the central axis 13 through the cooperation of the square holes and the square column 131. The first square hole 112 and the second square hole 122 cooperate with the square column 131, so that the axial relative displacement between the upper main body 11 and the lower main body 12 is restricted.

[0107] See Figure 2 , the main body 1 further includes a spring 15. Placement grooves are provided on both the upper main body 11 and the lower main body 12, namely a first placement groove 113 and a second placement groove 123 respectively. Both ends of the spring 15 respectively abut against the first placement groove 113 and the second placement groove 123, and are arranged in the placement grooves of the upper main body 11 and the lower main body 12, that is, respectively abut against the bottoms of the first placement groove 113 and the second placement groove 123, forming an elastic support for the upper main body 11 and the lower main body 12. When the fastening nut 14 is loose, due to the elastic support of the spring 15, within a certain range, the upper main body 11 and the lower main body 12 can still maintain a relatively stable state.

[0108] See Figure 2 , a slot 16 is provided on the outer wall of the main body 1, and the winding post 2 is fixed on the main body 1 through the slot 16. The winding post 2 is fixed perpendicular or inclined to the surface of the main body 1, and the inclination angle between the winding post 2 and the surface of the main body 1 is 90° - 135°. In this embodiment, the shape of the slot 16 is cylindrical, and in other embodiments, the shape of the slot 16 can also be rectangular or polygonal prism-shaped.

[0109] See Figure 8 , in this embodiment, the winding post 2 is a columnar structure with a smooth end, and the winding post 2 is arranged at 90° to the surface of the main body 1. See Figures 9 - 12 , in other embodiments, the column of the winding post 2 can also be curved, it can be curved at one end, or it can be curved at both ends, it can be curved on one side of the column surface, or it can be curved on both sides of the column surface, and the winding post 2 can also be arranged at an angle to the surface of the main body 1. According to the different shapes of the slot 16, the shape of the part of the winding post 2 connected to the slot 16 is also different.

[0110] In this embodiment, the diameter of the main body 1 is 20 mm - 60 mm.

[0111] In this embodiment, referring to Figures 4 - 7 , the upper main body 11 includes an integral first cylinder 114 and a second cylinder 115, and the outer diameter of the first cylinder 114 is greater than that of the second cylinder 115. The outer diameter of the lower main body 12 is the same as that of the first cylinder 114. The first cylinder 114, the second main body 114, and the lower main body 12 are all cylindrical. The diameter of the second cylinder 115 is set to be smaller than the diameters of the first cylinder 114 and the lower main body 12, which enables the silk thread to be woven more conveniently.

[0112] Referring to Figures 4 - 5 , the main body 1 is also provided with a ventilation hole 17 for the air circulation between the center of the tooling and the outside, which helps to improve the heating and cooling speeds of the tooling during the later shaping of the bracket.

[0113] Embodiment Two

[0114] This embodiment provides a bracket weaving tooling and a corresponding bracket weaving and forming method, and the weaving is carried out by using the bracket weaving tooling in Embodiment One.

[0115] Specifically, in this embodiment, referring to Figure 14 , the winding columns 2 are divided into four rows, and are all arranged in a ring around the main body 1, namely Area A 21, Area B 22, Area C 23, and Area D 24. The number and spacing of the winding columns in Area A 21 and Area D 24 are the same and are aligned up and down, and are respectively arranged on the first cylinder 114 and the lower main body 12. The number and spacing of the winding columns in Area B 22 and Area C 23 are the same and are aligned up and down, and are both arranged on the second cylinder 115. And the spacing between Area B 22 and Area C 23 is greater than or equal to the diameter of the silk thread.

[0116] Among them, the axial distances between Area A and Area B and between Area C and Area D are equal, which is H1, the axial distance between Area B and Area C is H2, the winding columns in Area A and Area D are aligned up and down and are evenly distributed on a circumference respectively, and the distance is L1; the winding columns in Area B and Area C are aligned up and down and are evenly distributed on a circumference respectively, and the distance between every two winding columns in the circumferential direction is 2L1, and the winding column B1 is 1 / 2 of L1 away from A2 in the circumferential direction.

[0117] In this embodiment, the tooling is a 14-column tooling CT1, that is, according to the number of winding columns in Area A and Area D are 14 respectively, and the number of winding columns in Area B and Area C are 7 respectively, and the arrangement method is an equidistant and equally divided circumferential arrangement.

[0118] The winding post 2 further includes an initial winding post 25 for determining the initial braiding position of the silk thread and ensuring that the silk thread does not slip relatively during the braiding process. In this embodiment, the initial winding post 25 is disposed above the winding post in area A or the winding post 21 in area D.

[0119] The method for braiding and forming the stent includes the following steps:

[0120] Step 1: Fix the silk thread on the initial winding post and wind it around the winding posts of the tooling in sequence according to a specific braiding method, and wind it around the surface of the tooling for one week, wherein the silk thread is made of a degradable material or a non-degradable material;

[0121] Step 2: When braiding the second week, the winding path of the silk thread is geometrically complementary to the winding path of the first week;

[0122] Step 3: When braiding a new week each time, the winding path of the silk thread is geometrically complementary to the winding path of the previous week, and so on to complete the preliminary braiding to form a preliminarily formed stent;

[0123] Step 4: Locally connect and fix the preliminarily formed stent, and perform connection and fixation treatment on the parts of initial braiding, end braiding and silk thread crossing;

[0124] Step 5: Heat-treat the stent after local connection and fixation treatment to complete the heat setting of the stent;

[0125] Step 6: Rapidly cool down the heat-set stent at a low temperature to complete the entire braiding and setting of the stent.

[0126] In this embodiment, the material of the silk thread is poly(lactic-co-glycolic acid) (PLGA), one of the degradable polymer materials, which has excellent biocompatibility, in vivo degradability, non-toxic and absorbable degradation products, good moldability and good mechanical properties. It is already one of the materials certified by the US FDA to be used as a pharmaceutical excipient and is widely used in the medical industry, such as surgical sutures, drug carriers, etc. The diameter selection range of the silk thread is 0.1 mm - 2.0 mm.

[0127] The braiding method of the silk thread can be selected as a single silk thread braided according to the "big W and small v" path method; that is Figure 15 The provided braiding method is used to wind the stent Figure 13 The developed view of the braided stent is as Figure 16As shown. Specifically, the circumferential direction of the tooling is taken as the winding direction. The silk thread takes the initial winding post 25 as the starting point of braiding. After fixing the silk thread on the initial winding post 25, it directly extends to the winding post D2, extends to the winding post C1 after winding around D2 counterclockwise for one and a half turns, extends to the winding post D3 after winding around C1 counterclockwise for one and a half turns, and extends to the winding post A4 after winding around D3 counterclockwise for one and a half turns. Thus, the winding of a "big W" is completed; continue braiding, extend to the winding post B2 after winding around A4 counterclockwise for one and a half turns, and extend to the winding post A5 after winding around B2 counterclockwise for one and a half turns, that is, the winding of a "small V" is completed. The above completes the braiding of a "big W small V" unit, and repeating the above "big W small V" path completes the braiding of the first week. The braiding of the second week is complementary to that of the first week, such as Figure 15 The gray line part, the braiding method is the same, and for the silk thread crossing part, it can be all covered by braiding, or the two methods of covering and passing through can be alternated.

[0128] More specifically, the initial winding post 25 is the position where the silk thread is fixed at the beginning of braiding to ensure that the silk thread does not slip relatively during the braiding process. The diameter and shape of the initial winding post 25 can be the same as those of the ordinary winding post, and its position can be in Scheme 1 above the winding post A1 ( Figure 17 The gray line in) or in Scheme 2 on the right ( Figure 17 The black line in), and the specific position is determined according to the winding method and wire diameter of the silk thread. When the braiding is completed, it is required that the head and tail silk threads can be aligned without gaps, such as Figure 25 Shown.

[0129] The winding method of the winding posts at both ends of the bracket can be the form that the silk thread winds around the winding post counterclockwise, and the winding method is as Figure 18a Shown and the vertex of the formed bracket is as Figure 18b Shown; it can be the form that the silk thread winds around the winding post counterclockwise and winds one turn, and the winding method is as Figure 19a The front view of and Figure 20a The side view of shown, and the vertex of the formed bracket is as Figure 19b The front view of and the side view of 20b shown; it can also be the form that the silk thread winds around the winding post clockwise, and the winding method is as Figure 21a Shown and the vertex of the formed bracket is as Figure 21b Shown; it can also be the form that the silk thread winds around the winding post clockwise and winds one turn, and the winding method is as Figure 22a The front view of and Figure 23a The side view of shown, and the vertex of the formed bracket is as Figure 22b The front view of and the side view of 23b shown.

[0130] The winding in the B and C winding post areas can be carried out according to Figures 24a - 24g Shown, Figure 24a , 24dAs shown, the distance between the two winding posts is twice the silk thread diameter, and the winding scheme includes winding half a turn of the inner circle ( Figure 24a ), and two forms of winding one and a half turns of the inner circle ( Figure 24d ). Figure 24b , 24c , 24e, 24f, and 24g show that the distance between the two winding posts is the diameter of a single silk thread, and the winding methods include winding half a turn of the inner circle ( Figure 24b ), winding one and a half turns of the inner circle ( Figure 24e ), winding one-fourth turn ( Figure 24c ), winding five-fourths turns of the outer circle ( Figure 24f ), and winding three-half turns of the outer circle ( Figure 24g ) and other various forms. Different winding forms provide different radial forces for the stent. In order to make the radial force of the stent more uniform, generally, the same braiding form is adopted within one stent. When the stent braiding is completed, the silk thread returns to the winding post A1 after winding around the winding tool for two turns, extends to D2 after winding three-half turns around the winding post A1, and aligns with the initial winding. The developed view of the stent after braiding is as shown in Figure 16 .

[0131] Example 3

[0132] This example provides a stent braiding tooling and a corresponding stent braiding and forming method, and uses the improved stent braiding tooling in Example 1 for braiding.

[0133] Specifically, in this example, the winding posts 2 are divided into six rows, all arranged in a ring around the main body 1, namely area A 21, area B 22, area C 23, area D 24, area E 26, and area F 27.

[0134] The number of winding posts in area E 26 and area F 27 is equal and they are aligned vertically. Area E 26 is arranged between area A 21 and area B 22, and area F 27 is arranged between area C 23 and area D 24, where the distances between area A 21 and area E 26, area E 26 and area B 22, area C 23 and area F 27, and area F 27 and area D 24 are equal.

[0135] In this example, referring to Figure 26 , the tooling is tooling CT2. The number of winding posts in area A 21 and area D 24 is 14 respectively, the number of winding posts in area B 22 and area C 23 is 14 respectively, and the number of winding posts in area E 26 and area F 27 is 28 respectively. The arrangement of the winding posts is evenly spaced arrangement of bisecting the circumference.

[0136] The winding posts in area E 26 and area F 27 serve as the inflection points of the stent, increasing the circumferential support force during stent compression and thus increasing the overall radial force of the drug-eluting stent. As shown in Figure 29a and Figure 29b, the diameters D2 or D3 of the winding posts in area E 26 and area F 27 can be the same as the diameter D1 of the winding posts in areas A, B, C, and D, or they can be different. Theoretically, when the diameter of the winding post is within a certain range, the larger the diameter D2 or D3, that is, the larger the angles α and β, the greater the radial force provided to the drug stent. Optionally, when the braided silk thread extends from the winding post A1 to the winding post B1, the way the silk thread bypasses the winding post E1 can be just bypassing the winding post, or the number of winding turns around the winding post E1 can be increased; it can be clockwise or counterclockwise, and the clockwise and counterclockwise directions are selected according to the radial force requirements of the drug stent.

[0137] In this embodiment, the method for braiding and forming the stent is the same as that in Embodiment 2 as a whole, except for the way of winding the silk thread in Step 1 and Step 2. In this embodiment, the winding way of the silk thread can be selected to braid the stent by a single silk thread according to the "big W and small v" path method. The initial winding post 25 is selected Figure 17 at position 1, and at the winding post at the end of the stent, according to Figure 19a the winding scheme, and at the winding posts in area E 26 and area F 27 of the stent, according to Figure 24c and 24d the winding scheme. After the silk thread is fixed at the initial winding post 25, it extends to the right of the winding post E1 and bypasses it clockwise and then extends to the winding post B1, respectively bypassing the left side of the winding post B1 counterclockwise and the right side of the winding post C1 clockwise and then extending to the winding post F2. The silk thread bypasses the left counterclockwise side of the winding post F2 and extends to the winding post D2, winds around the winding post D2 counterclockwise for one and a half turns and then extends to the winding post F3, bypasses the right side of the winding post F3 counterclockwise and then extends to the winding post C2 and winds around it for one and a half turns and then extends to the winding post F4. The silk thread bypasses the left side of the winding post F4 counterclockwise for one and a half turns and then extends to the winding post F5, and bypasses the right side of the winding post F5 counterclockwise and then extends to the winding post C3. The silk thread bypasses the left side of the winding post C3 clockwise and the right side of the winding post B3 counterclockwise and then extends to the winding post E6. The silk thread bypasses the left side of the winding post E6 clockwise and then extends to the winding post A4, winds around the winding post A4 for one and a half turns to complete the braiding of the "big W". After winding around the winding post A4, the silk thread bypasses the right side of the winding post E7 clockwise and then extends to the winding post B4. The silk thread winds around the winding post B4 for one and a half turns and then extends to E8 and bypasses the left side of the winding post E8 and then extends to A5, winds around the winding post A5 for one and a half turns to complete the braiding of the "small v". At this point, the silk thread has completed the braiding of a "big W and small v" unit. Next, repeat this braiding method to complete the first week of braiding of the winding tooling. The braiding path of the second week is geometrically complementary to the braiding path of the first week, and the braiding method refers to the first week's winding scheme to complete the braiding of the entire stent. The braiding method of the silk thread is as Figure 27 shown, where the black line part is the first week of braiding of the stent, and the gray line is the second week of braiding of the stent. The treatment method for the tail refers to Figure 25。The developed view of the stent woven according to this weaving method is as shown in Figure 28 shown.

[0138] Example 4

[0139] This example provides a stent weaving tooling and a corresponding stent weaving and forming method, and the improved stent weaving tooling in Example 1 is used for weaving.

[0140] Specifically, in this example, the stent weaving tooling is tooling CT3. The winding posts 2 are divided into four rows, including area A 21, area B 22, area C 23 and area D 24. The setting positions of area B 22 and area C 23 are the same as the setting positions of area E 26 and area F 27 on tooling CT2.

[0141] See Figure 30 , tooling CT3 is a 13-post tooling. The number of winding posts in area A 21 and area D 24 is 13 respectively, and the number of winding posts in area B 22 and area C 23 is 26 respectively. The arrangement mode of the winding posts is equally spaced arrangement by bisecting the circumference.

[0142] In this example, the stent weaving and forming method is the same as that in Example 2 as a whole. The difference is the silk winding mode in Step 1 and Step 2. In this example, the winding mode of the silk is to select a single silk to weave the stent in the path mode of "big V". The initial winding post 25 is selected Figure 17 from one of the positions, and the winding scheme at the winding post at the stent end point is based on Figure 19a . After the silk is fixed at the initial winding post 25, it extends to the right of winding post B1 and winds counterclockwise around winding post B1, extends to the left of winding post C2 and winds around winding post C2 and extends to B2. The silk winds counterclockwise for one and a half weeks around winding post B2 and then extends to the right of winding post C3, winds counterclockwise around winding post C3 and then extends to the left of winding post B4, winds clockwise around the left side of winding post B4 and then extends to the left of winding post A3. After the silk winds around the winding post for one and a half weeks, the weaving of a "V" unit is completed. Next, the weaving of the silk repeats the weaving method of the "V" unit, controls the direction of the silk, and completes the weaving of the first week. The weaving path of the silk in the second week is in a geometric complementary shape to the weaving path of the silk in the first week. The weaving method refers to the weaving path of the silk in the first week. The weaving method of the silk is as shown in Figure 31 shown, where the black line part is the first-week weaving of the stent, and the gray line is the second-week weaving of the stent. The developed view of the woven stent is as shown in Figure 32 shown.

[0143] Example 5

[0144] This example provides a stent weaving tooling and a corresponding stent weaving and forming method, and the improved stent weaving tooling in Example 1 is used for weaving.

[0145] Specifically, in this embodiment, the wire-winding columns 2 are divided into six rows, all arranged in a ring around the main body 1, namely area A 21, area B 22, area C 23, area D 24, area E 26 and area F 27.

[0146] In this embodiment, the stent braiding tooling is tooling CT4. The setting positions of the wire-winding columns in each area are the same as those of CT2 in Embodiment 3. However, the tooling selected in this embodiment is a 14-column tooling. That is, the number of wire-winding columns in area A and area D is 14 respectively, the number of wire-winding columns in area B and area C is 7 respectively, and when the number of wire-winding columns in area E and area F is 28 respectively, the arrangement methods are all equally spaced and evenly divided circular arrangements.

[0147] In this embodiment, the stent braiding and forming method is the same as that in Embodiment 2 as a whole. The difference lies in the wire-winding methods in Step 1 and Step 2. The wire-winding method involved in this embodiment is the same as that in Embodiment 2, that is, a single wire is braided according to the "big W and small v" path method. The initial wire-winding column and the wire-winding method of each wire-winding column are the same. Different from it, each time the wire extends from the end wire-winding column to the inner wire-winding column, the inflection point of the wire needs to be increased on the right or left side of the wire-winding columns in area E and area F. For the specific local braiding method, refer to the local braiding method in Embodiment 3. The developed view of the braided stent is as Figure 33 shown. The black lines in the figure are the first-week braiding paths of the stent, and the gray lines are the second-week braiding paths of the stent.

[0148] Embodiment 6

[0149] This embodiment provides a stent braiding tooling and a corresponding stent braiding and forming method, and uses the improved stent braiding tooling in Embodiment 1 for braiding.

[0150] Specifically, the stent braiding tooling is tooling CT5. Based on tooling CT1, by changing the number and arrangement rules of the wire-winding columns in area B and area C, the braiding of another form of stent is realized. Tooling CT5 is a 12-column tooling. The number of wire-winding columns in area A and area D is 12 respectively, and the number of wire-winding columns in area B and area C is 4. The wire-winding columns are all equally spaced and evenly divided circular arrangements.

[0151]

[0152] ​In this embodiment, the stent braiding and forming method is the same as that in Embodiment 2 as a whole. The difference lies in the wire winding methods in Step 1 and Step 2. The wire winding method involved in this embodiment selects to braid two wires in the "big W" path mode. However, since this braiding method uses two wires for braiding, after the first wire completes the first week of braiding according to the "W" part braiding method described in Embodiment 2, it is necessary to connect the head and tail of the wire braided in the first week before starting the braiding of the second week of wire. To ensure that the stent has a relatively uniform radial supporting force, the starting point of the second week of braiding can be the same as the starting point of the first week of braiding, or it can be the opposite position. The braiding direction can be the same as or opposite to that of the first week of braiding. The developed view of the stent after braiding is as shown in Figure 34a and 34b shown. The gray lines and black lines in the two figures are the braiding paths of the two wires respectively. Figure 34a As shown in Figure 34a , one of the wires (shown as the black line) starts braiding with the winding post A1 as the starting winding post for braiding, and the other wire (shown as the gray line) starts braiding with the winding post D1 as the starting winding post for braiding. Figure 34b As shown in Figure 34b , one of the wires (shown as the black line) starts braiding with the winding post A1 as the starting winding post for braiding, while the other wire (shown as the gray line) starts braiding with the winding post D7 as the starting winding post for braiding.

[0153] Embodiment 7

[0154] This embodiment provides a stent braiding tooling and a corresponding stent braiding and forming method, and uses the modified stent braiding tooling in Embodiment 1 for braiding.

[0155] Specifically, the stent braiding tooling is tooling CT6. Based on tooling CT1, by changing the number and arrangement rules of the winding posts in Area B and Area C, the braiding of another form of stent is realized. Tooling CT6 is a 12-post tooling. The number of winding posts in Area A and Area D is 12 respectively, and the number of winding posts in Area B and Area C is 6. The winding posts are evenly arranged and bisect the circumference.

[0156] In this embodiment, the stent braiding and forming method is the same as that in Embodiment 2 as a whole. The difference lies in the wire winding methods in Step 1 and Step 2. The braiding path of the wire in this embodiment is the same as that in Embodiment 2, and it is braided in the "big W small v" path mode. The difference from Embodiment 2 is the number of winding posts in Area A and Area D, and the number of braiding wires is two. During the braiding process of the stent, the specific braiding path of the wire is as described in Embodiment 2. As described in Embodiment 6, during the braiding process, when the stent completes the first week of braiding, it is necessary to connect the wire in the first week and then perform the second week of braiding. The selection of the braiding starting point is the same as that in Embodiment 6.

[0157] The developed view of the stent braided by the above method is as shown inFigure 35a and Figure 35b As shown, the two colored lines in the figure identify the two silk threads for braiding the stent. Figure 35a As shown, the braiding starts from A1 and D1 respectively. Figure 35b As shown, the braiding starts from A1 and D7 respectively.

[0158] Embodiment Eight

[0159] This embodiment provides a stent braiding tooling and a corresponding stent braiding and forming method, and the modified stent braiding tooling in Embodiment One is used for braiding.

[0160] Specifically, the stent braiding tooling is Tooling CT7. Based on Tooling CT1, by changing the number and arrangement pattern of the wire winding columns in Area B and Area C, the braiding of another form of stent is realized. Tooling CT7 is a 12-column tooling. The number of wire winding columns in Area A and Area D is 15 respectively, and the number of wire winding columns in Area B and Area C is 3. The wire winding columns are evenly arranged in a circular circumference at equal distances.

[0161] In this embodiment, the stent braiding and forming method is the same as that in Embodiment Two as a whole. The difference lies in the wire winding methods in Step One and Step Two. The wire braiding path in this embodiment is braided in the "big W and big V" path mode. The local details of the winding during the braiding process are the same as those in Embodiment Two. The difference is that the braiding method in this embodiment is double-wire braiding, and the double-wire braiding process and treatment method are the same as those in Embodiment Six and Embodiment Seven.

[0162] The developed view of the stent braided in this embodiment is as shown in Figure 36a and Figure 36b As shown, the two colored lines in the figure identify the two silk threads for braiding the stent. Figure 36a As shown, the braiding starts from A1 and D1 respectively. Figure 36b As shown, the braiding starts from A1 and A8 respectively.

[0163] Embodiment Nine

[0164] This embodiment provides a stent braided according to the stent braiding and forming methods provided in Embodiments Two to Eight.

[0165] The above are only the preferred embodiments of the present invention, and thus do not limit the patent protection scope of the present invention. Any equivalent structural transformation made by using the content of the specification and drawings of the present invention, directly or indirectly applied in other related technical fields, shall be included in the protection scope of the present invention by the same token.

Claims

1. A method for braiding and forming a stent, characterized in that, The stent braiding tooling for braiding and forming a stent includes a main body and several winding columns. The main body is cylindrical, drum-shaped or dumbbell-shaped. The winding columns are arranged around the surface of the main body. The winding columns include an initial winding column and a braiding winding column. The braiding winding column includes four rows of winding columns arranged in parallel, which are respectively area A, area B, area C and area D in sequence. The number and spacing of the winding columns in area A and area D are the same and are aligned up and down. The number and spacing of the winding columns in area B and area C are the same and are aligned up and down. The braiding and forming of the stent braiding tooling includes the following steps: Step 1: Fix the silk thread on the initial winding column, and then wind it around the braiding winding columns of the tooling in sequence, winding one week along the surface of the tooling, where the silk thread is made of a degradable material or a non-degradable material; Step 2: When performing the second week of braiding, the winding path of the silk thread is geometrically complementary to the winding path of the first week. The first week of braiding is carried out in a counterclockwise or clockwise winding manner in the path of a "V" shape, and the second week of braiding forms a geometrically complementary braiding manner according to the first week of braiding method; Step 3: When performing a new week of braiding each time, the winding path of the silk thread is geometrically complementary to the winding path of the previous week. In this way, the preliminary braiding is completed by cycling, and a preliminarily formed stent is formed; Step 4: Perform local connection and fixation on the preliminarily formed stent, and perform connection and fixation treatment on the parts of initial braiding, end braiding and silk thread crossing; Step 5: Perform heat treatment on the stent after local connection and fixation treatment to complete the heat setting of the stent; Step 6: Perform rapid cooling on the stent after heat setting at a low temperature to complete the entire braiding and setting of the stent; In Step 1, when the number of winding columns in area A and area D is 3n or 3n + 1 respectively, and the number of winding columns in area B and area C is n; or when the number of winding columns in area A and area D is 3n + 2 respectively, and the number of winding columns in area B and area C is n + 1 respectively, the winding method of the silk thread is wound in the path of a "big W", where n is an integer from 1 to 15.

2. A method for braiding and forming a stent, characterized in that, The stent braiding tooling for braiding and forming a stent includes a main body and several winding columns. The main body is cylindrical, drum-shaped or dumbbell-shaped. The winding columns are arranged around the surface of the main body. The winding columns include an initial winding column and a braiding winding column. The braiding winding column includes four rows of winding columns arranged in parallel, which are respectively area A, area B, area C and area D in sequence. The number and spacing of the winding columns in area A and area D are the same and are aligned up and down. The number and spacing of the winding columns in area B and area C are the same and are aligned up and down. The braiding and forming of the stent braiding tooling includes the following steps: Step 1: Fix the silk thread on the initial winding column, and then wind it around the braiding winding columns of the tooling in sequence, winding one week along the surface of the tooling, where the silk thread is made of a degradable material or a non-degradable material; Step 2: When performing the second week of braiding, the winding path of the silk thread is geometrically complementary to the winding path of the first week. The first week of braiding is carried out in a counterclockwise or clockwise winding manner in the path of a "V" shape, and the second week of braiding forms a geometrically complementary braiding manner according to the first week of braiding method; Step 3: When starting a new week of weaving each time, the winding path of the silk thread is geometrically complementary to that of the previous week. Repeat this cycle to complete the preliminary weaving and form a preliminarily shaped bracket. Step 4: Perform local connection and fixation on the preliminarily shaped bracket, and conduct connection and fixation treatment on the parts of initial weaving, end weaving, and silk thread crossing. Step 5: Heat-treat the bracket after local connection and fixation to complete the heat setting of the bracket. Step 6: Rapidly cool down the bracket that has completed heat setting at a low temperature to complete the overall weaving and setting of the bracket. In Step 1, when the number of winding columns in Area A and Area D is 4n or 4n + 1 respectively, and the number of winding columns in Area B and Area C is 2n respectively; or when the number of winding columns in Area A and Area D is 4n + 2 or 4n + 3 respectively, and the number of winding columns in Area B and Area C is 2n + 1 respectively, the silk thread is wound in the "big W, small v" path mode, where n is an integer from 1 to 15.

3. A method for braiding and forming a stent, characterized in that: The bracket weaving tooling for forming the bracket includes a main body and several winding columns. The main body is cylindrical, drum-shaped, or dumbbell-shaped. The winding columns are arranged around the surface of the main body. The winding columns include an initial winding column and weaving winding columns. The weaving winding columns include four rows of winding columns arranged in parallel, namely Area A, Area B, Area C, and Area D in sequence. The number and spacing of the winding columns in Area A and Area D are the same and are aligned vertically. The number and spacing of the winding columns in Area B and Area C are the same and are aligned vertically. The forming of the bracket by the bracket weaving tooling includes the following steps: Step 1: Fix the silk thread on the initial winding column, and then wind it around the weaving winding columns of the tooling in sequence, winding one week along the surface of the tooling. The silk thread is made of a degradable material or a non-degradable material. Step 2: When starting the second week of weaving, the winding path of the silk thread is geometrically complementary to that of the first week. The first week of weaving is wound in a counterclockwise or clockwise direction in the "V" path mode, and the second week of weaving forms a geometrically complementary weaving mode according to the first week of weaving mode. Step 3: When starting a new week of weaving each time, the winding path of the silk thread is geometrically complementary to that of the previous week. Repeat this cycle to complete the preliminary weaving and form a preliminarily shaped bracket. Step 4: Perform local connection and fixation on the preliminarily shaped bracket, and conduct connection and fixation treatment on the parts of initial weaving, end weaving, and silk thread crossing. Step 5: Heat-treat the bracket after local connection and fixation to complete the heat setting of the bracket. Step 6: Rapidly cool down the bracket that has completed heat setting at a low temperature to complete the overall weaving and setting of the bracket. In Step 1, when the number of winding columns in Area A and Area D is 5n or 5n + 1 respectively, and the number of winding columns in Area B and Area C is n respectively; or when the number of winding columns in Area A and Area D is 5n + 2 or 5n + 3 or 5n + 4 respectively, and the number of winding columns in Area B and Area C is n + 1 respectively, the silk thread is wound in the "big W, big V" path mode, where n is an integer from 1 to 15.

4. The stent braiding and forming method according to any one of claims 1-3, characterized in that: The woven winding column further includes E-zone and F-zone winding columns arranged in parallel, and the number of winding columns in the E-zone and the F-zone is equal and they are aligned vertically. The E-zone is arranged between the A-zone and the B-zone, and the F-zone is arranged between the C-zone and the D-zone, wherein the distances between the A-zone and the E-zone, the E-zone and the B-zone, the C-zone and the F-zone, and the F-zone and the D-zone are equal.

5. The stent braiding and forming method according to any one of claims 1-3, characterized in that: In step four, the connection and fixation treatment is a combination of one or more of mechanical structure connection, welding, and bonding.

6. A bracket, characterized in that: It is made by the bracket weaving and forming method as described in any one of claims 1-3.

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