Sniffing stent and preparation method thereof

Abstract

The invention relates to a sniffing stent and a preparation method thereof. The preparation method of the sniffing stent comprises the following steps: weaving a first wire material into a planar side stent; a second wire material is adopted to weave an annular peripheral surface support; and the side surface bracket and the peripheral surface bracket are connected into a whole, and the side surface bracket is positioned at the axial end part of the peripheral surface bracket. According to the sniffing stent obtained by the preparation method, the side stent is arranged to be planar, and the circumferential stent is arranged to be annular, so that the side stent is matched with the length and height of a sniffing area, the circumferential stent is matched with the width of the sniffing area, and the stability of the sniffing stent after being implanted into the sniffing area of the nasal cavity of a patient is improved; the traditional Chinese medicine composition has a certain expansion effect on sniffing and can effectively treat related inflammatory lesions in sniffing areas.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an olfactory cleft stent and a preparation method thereof. Background Art

[0002] The olfactory cleft (also known as the olfactory groove) is located in the upper and middle part of the nasal cavity. It is in the shape of a cleft, and its permeability is crucial to maintaining normal sense of smell.

[0003] When inflammatory lesions occur in the olfactory cleft area, due to the narrow spatial structure of the olfactory cleft area, mucosal inflammation in this area often leads to poor drainage of the olfactory cleft area, secretion accumulation, mucosal congestion, submucosal inflammatory cell infiltration, etc. Clinical treatment often involves spraying drugs into the olfactory cleft area. Conventional nasal spraying positions use an upright position or a head-down supine position. The nasal spraying method is difficult to accurately deliver drugs to the olfactory cleft area. Moreover, liquid drugs often flow into the throat along the side wall of the nasal cavity through the middle nasal meatus or even the common nasal meatus, while the drugs are less retained in the olfactory cleft area, thus having no therapeutic effect on the olfactory cleft area or having little effect. If the inflammation is severe, oral hormone therapy can also be used clinically. Considering the concurrent bacterial infection, antibiotic therapy will be combined, but these treatment methods have potential systemic adverse reactions, poor patient compliance, and the treatment effects are mostly short-lived and cannot be sustained.

[0004] When polyps form in the olfactory cleft area, blockage of nasal secretions and other reasons prevent gas molecules from reaching the olfactory cleft area and binding to the olfactory receptors. Clinically, endoscopic surgery is generally used to remove olfactory cleft polyps. However, due to the narrow spatial structure and hidden location of the olfactory cleft area, it is difficult to identify the polyps in detail. At the same time, the surrounding normal mucosa may be torn when the polyps are removed. If the normal olfactory mucosal epithelium is not protected during the operation, irreversible damage to the olfactory receptors may be caused. Summary of the invention

[0005] Based on this, it is necessary to provide an olfactory cleft stent and a preparation method thereof to address the above technical problems.

[0006] A method for preparing an olfactory cleft stent, the method comprising:

[0007] A side bracket is woven into a planar shape using the first wire material;

[0008] A second wire material is used to weave into a ring-shaped peripheral bracket;

[0009] The side bracket is connected to the peripheral bracket as a whole, and the side bracket is located at the axial end of the peripheral bracket.

[0010] In one embodiment, the side bracket and the peripheral bracket can be woven using a woven tool, the woven tool has a first side surface and a second side surface that are arranged opposite to each other, and a circumferential surface connected to the first side surface and the second side surface, a plurality of side positioning pins are arranged on the first side surface and / or the second side surface, and a plurality of peripheral positioning pins are arranged on the circumferential surface;

[0011] The braiding step of the side bracket and the peripheral bracket includes:

[0012] Moving the first wire material on the first side or the second side of the braiding tool, and winding the first wire material around the side positioning pin during the movement to braid and form a side bracket;

[0013] The second wire material is moved on the circumferential surface of the braiding tool, and is wound around the circumferential surface positioning pins during the movement to weave into a circumferential surface bracket.

[0014] In one embodiment, the side positioning pins are arranged in sequence along the edge of the first side surface or the second side surface;

[0015] The side bracket is a grid-shaped bracket; the weaving step of the side bracket includes: taking any of the side positioning pins as a first starting point, and making the first wire material bend and move repeatedly in a hook shape between the side positioning pins until it returns to the first starting point.

[0016] In one embodiment, the number of the side positioning pins is 2m+2, and the first wire can be woven into m quadrilateral meshes after being wrapped around all the side positioning pins, wherein m is an integer greater than or equal to 1.

[0017] In one embodiment, the distance between the side positioning pin and the edge of the first side surface or the second side surface is 1 to 1.5 times the wire diameter of the first wire material.

[0018] In one embodiment, the circumferential positioning pins are arranged at intervals along the circumference of the braiding tool, the number of the second wire materials is multiple, and the braiding steps of the circumferential support include:

[0019] A plurality of the second wires are moved side by side on the circumferential surface along the circumference of the braiding tool until they are wound on the circumferential surface for at least one circle, wherein when passing through each circumferential surface positioning pin, all the second wires are wound around each circumferential surface positioning pin.

[0020] In one embodiment, the braiding step of the peripheral support includes:

[0021] Any position of the circumferential surface is used as the second starting point, and one of the second wires is moved on the circumferential surface with the circumference of the braiding tool as the winding direction. When passing through each circumferential surface positioning pin, the second wire is wrapped around the circumferential surface positioning pin for at least half a circle, and then continues to move in the original winding direction until it returns to the second starting point; repeat the above steps to weave the remaining second wires.

[0022] In one embodiment, the second wire material close to the first side surface or the second side surface is wrapped around the circumferential positioning pin half a circle, and the second wire material located in the middle of the circumferential surface is wrapped around the circumferential positioning pin one and a half circles.

[0023] In one embodiment, the circumferential surface is sequentially provided with a plurality of annular grooves along the circumference of the braiding tool in the axial direction, and the second wire material can move in the corresponding annular grooves.

[0024] In one embodiment, the depth of the annular groove is 0.3 to 0.7 times the wire diameter of the second wire.

[0025] In one embodiment, the length L of the braided tooling is 25 mm to 30 mm, the width W is 1.5 mm to 3 mm, and the height H is 28 mm to 32 mm; and / or, the first filament and the second filament are made of degradable material or non-degradable material.

[0026] An olfactory cleft stent comprises an annular circumferential support and two planar side supports, wherein the circumferential support and the side supports are processed by any of the preparation methods described above, and the two side supports are respectively arranged at the axial ends of the circumferential support and are both connected to the circumferential support.

[0027] In one of the embodiments, the peripheral support and the side support are processed by any of the preparation methods described above.

[0028] In one embodiment, a drug layer is provided on the surface of the peripheral support and / or the side support.

[0029] The above-mentioned olfactory cleft stent and its preparation method, by setting the side stent to a plane shape and the circumferential stent to a ring shape, so that the lateral stent is adapted to the length and height dimensions of the olfactory cleft area, and the circumferential stent is adapted to the width dimension of the olfactory cleft area, improves the stability of the olfactory cleft stent after being implanted in the olfactory cleft area of ​​the patient's nasal cavity, then after the olfactory cleft stent is unfolded, it can have a certain expansion effect on the olfactory cleft, which will reduce the situation that gas molecules cannot reach the olfactory area and bind to the olfactory receptors due to inflammatory swelling of the olfactory mucosa, polyps, nasal secretion blockage, etc., increase the patency of the olfactory cleft, and can also cover the drug on the surface of the stent, so that the drug can be accurately and slowly released to the olfactory cleft, making up for the current systemic treatment of oral hormones, antibiotics and other drugs in clinical practice; in addition, the stent can also be set to a degradable material, without the need for a second surgery to remove it. It can be seen that the olfactory cleft stent can effectively treat inflammatory lesions related to the olfactory cleft area, such as rhinitis, mild olfactory cleft polyps and other diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 A schematic flow chart of a method for preparing an olfactory cleft stent provided in one embodiment of the present application.

[0031] Figure 2 A schematic structural diagram of a knitting tool provided in one embodiment of the present application.

[0032] Figure 3 A side view of a knitting work garment provided in accordance with an embodiment of the present application.

[0033] Figure 4 This is a schematic diagram of the olfactory cleft stent provided in one embodiment of the present application before being grasped and pressed.

[0034] Figure 5 A structural diagram of a side bracket provided in one embodiment of the present application.

[0035] Figure 6 This is a force diagram of the olfactory cleft stent provided in one embodiment of the present application when being grasped and pressed.

[0036] Figure 7 This is a schematic diagram of the structure of the olfactory cleft stent after being grasped and pressed provided in one embodiment of the present application.

[0037] Figure 8 A schematic diagram of the weaving direction of the first wire material provided in one embodiment of the present application.

[0038] Fig. 9 A schematic diagram of the weaving direction of the second wire material provided in one embodiment of the present application.

[0039] Fig.10 A schematic diagram of a second wire material being wound around a peripheral positioning pin provided in an embodiment of the present application.

[0040] Fig.11 A structural diagram of a peripheral support provided in one embodiment of the present application. DETAILED DESCRIPTION

[0041] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0042] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0043] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0044] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0045] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0046] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0047] See also Figure 1 , Figure 1 A schematic flow chart of a method for preparing an olfactory cleft stent 10 in an embodiment of the present application is shown. The preparation method provided in an embodiment of the present application comprises the following steps:

[0048] S100, using a first wire material to weave a surface-shaped side bracket 100;

[0049] S200, using the second wire material to weave into a ring-shaped peripheral support 200;

[0050] S300 , connecting the side support 100 and the peripheral support 200 as one body, and locating the side support 100 at the axial end of the peripheral support 200 .

[0051] The olfactory cleft stent 10 prepared by the preparation method is configured such that the side stent 100 is adapted to the length and height of the olfactory cleft area, and the circumferential stent 200 is adapted to the width of the olfactory cleft area, thereby improving the stability of the olfactory cleft stent 10 after implantation in the olfactory cleft area of ​​the patient's nasal cavity. It should be noted that the braiding steps of the side stent 100 and the circumferential stent 200 can be interchanged, that is, the circumferential stent 200 can be braided first, and then the side stent 100 can be braided.

[0052] In some embodiments of the present application, the side bracket 100 and the peripheral bracket 200 may be Figure 2 and Figure 3The shown weaving tool 20 is woven to improve the weaving efficiency of the side bracket 100 and the peripheral bracket 200, and can also ensure that the sizes of the side bracket 100 and the peripheral bracket 200 after weaving match.

[0053] Among them, Figure 2 and Figure 3 As shown, the knitting tool 20 has a first side surface 20a1 and a second side surface 20a2 which are arranged opposite to each other and a circumferential surface 20a3 which is connected to the first side surface 20a1 and the second side surface 20a2. A plurality of side positioning pins 30 are arranged on the first side surface 20a1 and / or the second side surface 20a2, and a plurality of circumferential surface positioning pins 40 are arranged on the circumferential surface 20a3.

[0054] Correspondingly, step S100 may include: moving the first wire material on the first side surface 20a1 or the second side surface 20a2 of the braiding tool 20 , and winding the first wire material around the side positioning pin 30 during the movement to braid and form the side bracket 100 .

[0055] Step S200 may include: moving the second wire material on the circumferential surface 20 a 3 of the braiding tool 20 , and winding the second wire material around the circumferential surface positioning pins 40 during the movement to braid and form the circumferential surface bracket 200 .

[0056] It should be noted that before the side bracket 100 and the peripheral bracket 200 are connected as one, the woven side bracket 100 and the peripheral bracket 200 need to be shaped.

[0057] See also Figure 2 The woven tooling 20 is flat to adapt to the spatial physiological structure of the olfactory cleft area, which is long, relatively large in height and narrow in width. Specifically, the length L of the woven tooling 20 is 25mm to 30mm (for example, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, etc.), the width W is 1.5mm to 3mm (for example, 1.5mm, 2mm, 2.5mm, 3mm, etc.), and the height H is 28mm to 32mm (for example, 28mm, 29mm, 30mm, 31m, 32mm, etc.).

[0058] The outer contour of the knitting tool 20, that is, the shape of the circumferential surface 20a3 of the knitting tool 20, can be a polygon such as an ellipse, rectangle, hexagon, octagon, dodecagon, etc., or a shape composed of a combination of straight lines and arcs.

[0059] Taking into account that the side bracket 100 and the peripheral bracket 200 will be subjected to heat setting treatment on the braided tooling 20 after weaving, the braided tooling 20 can be made of metal material, such as stainless steel, aluminum, titanium or alloy, etc.; it can also be made of high-temperature resistant polymer material, such as polytetrafluoroethylene (PTFE), tetrafluoroethylene-ethylene copolymer (ETFE), polyperfluoroethylene propylene (FEP), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyetherketone (PEK), etc., which can prevent the braided tooling 20 from being deformed during the heat setting process of the side bracket 100 and the peripheral bracket 200.

[0060] Similarly, the side positioning pins 30 and the peripheral positioning pins 40 are also made of metal or high temperature resistant polymer materials to prevent the side positioning pins 30 and the peripheral positioning pins 40 from deforming during the heat setting process of the side brackets 100 and the peripheral brackets 200. The material can be the same as or different from the material of the woven tooling 20.

[0061] The side positioning pins 30 and the peripheral positioning pins 40 can be detachably arranged on the braiding tool 20 by means of threaded connection, clamping, etc. After the side bracket 100 and the peripheral bracket 200 are finalized, the side positioning pins 30 and the peripheral positioning pins 40 can be removed from the braiding tool 20 to take out the side bracket 100 and the peripheral bracket 200. Figure 3 As shown, the first side surface 20a1 and the second side surface 20a2 of the knitting tool 20 are both provided with side positioning pins 30, and the side positioning pins 30 of the two side surfaces are aligned.

[0062] The number of side positioning pins 30 and peripheral positioning pins 40 can be set according to the required drug delivery area of ​​the olfactory cleft stent 10 and the stability of the stent structure. Among them, the olfactory cleft stent 10 can be targeted and fixed-point drug delivery to prevent the side effects that may be caused by systemic oral drugs currently used to treat inflammation in the olfactory cleft area. Considering that the olfactory cleft stent 10 is relatively small in size, the wire diameters of the first and second wires used for weaving are too small, and the drug can be provided on the surface of the olfactory cleft stent 10 by coating. It can be understood that the more the number of side positioning pins 30, the denser the first wire is wound, and the larger the area that the drug can be coated on the side stent 100; the more the number of peripheral positioning pins 40, the denser the second wire is wound, and the larger the area that the drug can be coated on the peripheral stent.

[0063] The diameter of the side positioning pins 30 and the peripheral positioning pins 40 can be 0.5mm to 1mm (for example, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, etc.), and the height can be 1mm to 2mm (for example, 1mm, 1.2mm, 1.4mm, 1.6mm, 1.8mm, 2mm, etc.). The specific size can be adjusted according to the wire diameter of the olfactory cleft stent 10.

[0064] Since the physiological structure of the olfactory cleft is relatively narrow, the width of the formed olfactory cleft stent 10 will also be narrow. Therefore, the wire diameters of the first and second wire materials can be selected from 0.1mm to 0.8mm (for example, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, etc.), preferably 0.2mm to 0.4mm.

[0065] The first and second filaments may be monofilaments or multifilaments, and may be formed into single strands or multiple strands of filaments.

[0066] The first and second wires are non-degradable materials or degradable materials. When the materials are degradable, no secondary surgery is required to remove the olfactory cleft stent 10. The first and second wires can be non-degradable metal materials, such as stainless steel, titanium, nickel-titanium alloy, etc. The first and second wires can also be degradable metal materials, such as pure magnesium and magnesium-based alloys, pure iron and iron-based alloys, pure zinc and zinc-based alloys, pure tungsten and tungsten-based alloys, and (calcium-based, zinc-based and strontium-based) bulk amorphous alloys. The first and second wires can also be non-degradable polymer materials, such as acrylonitrile-butadiene-styrene (ABS), polyacrylate, polymethacrylate, nylon (PA), polyolefin, polycarbonate (PC), fluorinated polymer, polyvinyl chloride (PVC), non-degradable polyester, polysulfone, polyethersulfone, polyether block amide, etc. Polymethacrylate can be polymethyl methacrylate or polybutyl methacrylate, polyolefin can be polyethylene (PE), polypropylene (PP), polystyrene (PS), etc., and fluorinated polymer can be polytetrafluoroethylene (PTFE). The first and second filaments may also be made of degradable polymer materials, such as polylactic acid (PLA), polyglycolide (PGA), lactic acid-glycolic acid copolymer (PLGA), polyglycolic acid / polylactic acid copolymer (PGLA), polycaprolactone (PCL), polybutylene succinate (PBS), polyorthoester (POE), polyvinyl alcohol (PVA), poly-β-hydroxybutyrate (PHB), polyhydroxyvalerate (PHV), copolymers of PHB and PHV (PHBV), polyhydroxyalkanoate (PHA), carbon dioxide copolymer (PPC), polyacyl lipid copolymer (CPAE), polyvinyl alcohol (PVA), and natural polymers such as polysaccharides, proteins, and nucleic acids. Among them, natural polymers include agar, alginate, cellulose, chitin, chitosan, dextran, glycogen, starch, lignin, chitin, collagen, fibrinogen, and derivatives of any of the above and mixtures of any of the above.

[0067] The following describes each of the above steps one by one:

[0068] In step S100, the first wire is wound and braided by the side positioning pins 30 to form Figure 5The grid-shaped stent shown, i.e., the side stent 100 is a grid-shaped stent. Compared with the wavy stent, the grid-shaped stent has a plurality of meshes 100a, which makes it easier to press and hold, and facilitates the placement of the olfactory cleft stent 10 into the sheath of the corresponding delivery system. Figure 6 The olfactory cleft stent 10 shown in the figure may be in the following shape after being pressed by an external force F. Figure 7 shown.

[0069] Among them, see Figure 2 As shown, the side positioning pins 30 are arranged in sequence along the edge direction of the first side 20a1 or the second side 20a2; the weaving steps of the side bracket 100 may specifically include: taking any side positioning pin 30 as the first starting point, and making the first wire material repeatedly bend and move in a hook shape between the side positioning pins 30 until it returns to the first starting point.

[0070] Below Figure 2 Taking the knitting tool 20 shown as an example, the knitting steps of the side bracket 100 are described. Among them, the first side 20a1 or the second side 20a2 of the knitting tool 20 is provided with 10 side positioning pins 30 at intervals along its edge direction, respectively. Figure 8 The first side positioning pin 30a, the second side positioning pin 30b, the third side positioning pin 30c, the fourth side positioning pin 30d, the fifth side positioning pin 30e, the sixth side positioning pin 30f, the seventh side positioning pin 30g, the eighth side positioning pin 30h, the ninth side positioning pin 30i and the tenth side positioning pin 30j are shown. Figure 8 The straight arrows in the figure represent the weaving direction of the first wire material.

[0071] The first wire starts from the first side positioning pin 30a and moves to the second side positioning pin 30b, and then moves to the ninth side positioning pin 50i with the second side positioning pin 30b as the turning point; when reaching the ninth side positioning pin 50i, move to the fourth side positioning pin 30d with the ninth side positioning pin 50i as the turning point; when reaching the fourth side positioning pin 30d, move to the seventh side positioning pin 30g with the fourth side positioning pin 30d as the turning point; when reaching the seventh side positioning pin 30g, move to the sixth side positioning pin 30f with the seventh side positioning pin 30g as the turning point; when reaching the sixth side positioning pin 30 f, then move toward the fifth side positioning pin 30e with the sixth side positioning pin 30f as the turning point; when reaching the fifth side positioning pin 30e, move toward the eighth side positioning pin 30h with the fifth side positioning pin 30e as the turning point; when reaching the eighth side positioning pin 30h, move toward the third side positioning pin 30c with the eighth side positioning pin 30h as the turning point; when reaching the third side positioning pin 30c, move toward the tenth side positioning pin 30j with the third side positioning pin 30c as the turning point; when reaching the tenth side positioning pin 30j, return to the first side positioning pin 30a with the tenth side positioning pin 30j as the turning point.

[0072] The number of the side positioning pins 30 is 2m+2. After the first wire is wrapped around all the side positioning pins 30, it can be woven into m quadrilateral meshes, where m is an integer greater than or equal to 1. Compared with other polygonal meshes, quadrilateral meshes are more easily deformed under the action of external forces, which is conducive to gripping. The number of quadrilateral meshes on the side bracket 100 can be set according to needs, such as 1, 2, 3, Figure 5 4 or more as shown.

[0073] The distance between the side positioning pin 30 and the edge of the first side surface 20a1 or the second side surface 20a2 is 1 to 1.5 times the wire diameter of the first wire material, for example, 1, 1.1, 1.2, 1.3, 1.4, 1.5, etc. With such arrangement, it can be ensured that the side bracket 100 and the peripheral bracket 200 have enough space for bonding or welding between the side bracket 100 and the peripheral bracket 200.

[0074] After the side bracket 100 is woven, it can be heat-set together with the weaving tooling 20, wherein the heat-setting temperature is between the glass transition temperature and the melting temperature of the first wire material, and the heat-setting time can be determined according to the specific material of the first wire material, and can be set to 1 hour to 2 hours. After the side bracket 100 is heat-set, it can be cooled together with the weaving tooling 20, wherein the cooling time is 0.5 hours to 1 hour, and the cooling temperature is -30°C to -10°C. Then, the side positioning pin 30 is removed from the weaving tooling 20 to remove the side bracket 100.

[0075] It should be noted that the side bracket 100 can also be heat-set together with the peripheral bracket 200 after the peripheral bracket 200 is woven.

[0076] After the side bracket 100 is heat-set, the first wires at each intersection of the side bracket 100 can also be connected by welding, bonding, etc. Of course, in order to facilitate the gripping and pressing of the olfactory cleft bracket 10, the first wires at all or part of the intersections of the side bracket 100 may not be connected.

[0077] In step S200, see Figure 2 and Figure 3 The circumferential positioning pins 40 of the present application are arranged at intervals along the circumference of the braided tooling 20, and the number of the second wire materials is multiple; the braiding steps of the circumferential bracket 200 may include: Fig. 9 , multiple second wires are moved side by side on the circumferential surface 20a3 along the circumference of the braiding tool until they are wound on the circumferential surface 20a3 for at least one turn, wherein when passing through each circumferential surface positioning pin 40, all the second wires are wound around each circumferential surface positioning pin 40 (see Fig. 9 and Fig.10 ).in, Fig. 9 Only the braiding directions of three second wires are shown, specifically, Fig. 9 The relatively dense dotted arrows represent the routing direction of the first second wire, the solid arrows represent the routing direction of the second second wire, and the relatively sparse dotted arrows represent the routing direction of the second second wire.

[0078] Since the width of the physiological structure of the olfactory cleft is relatively narrow, the width of the formed olfactory cleft stent 10 is also relatively narrow. Therefore, the width of the braiding tool 20 used to braid the olfactory cleft stent 10 is also relatively small, so that the circumferential surface 20a3 of the braiding tool 20 does not have sufficient space to meet the repeated bending of the second wire material. Fig.11 The peripheral support 200 shown does not need to repeatedly bend the second wire, and can also reduce the number of peripheral positioning pins 40 .

[0079] Specifically, the braiding steps of the peripheral support 200 of the present application may include: Fig. 9 As shown, any position of the circumferential surface 20a3 is used as the second starting point, and one of the second wires moves on the circumferential surface 20a3 with the circumference of the braiding shape 20 as the winding direction. When passing through each circumferential positioning pin 40, the second wire wraps around the circumferential positioning pin 40 for at least half a circle, and then continues to move in the original winding direction until it returns to the second starting point; repeat the above steps to weave the remaining second wires.

[0080] Below Fig. 9Taking the braiding tool 20 shown as an example, the braiding steps of the circumferential support 200 are described. Four circumferential positioning pins 40 are arranged on the circumferential surface 20a3 of the braiding tool 20; the circumferential surface 20a3 of the braiding tool 20 has three winding directions arranged side by side, namely the first winding direction, the second winding direction and the third winding direction.

[0081] The first second wire material is moved from the second starting point to the second side positioning pin 40 along the first winding direction when the first second wire material reaches the second side positioning pin 40. Fig. 9 As shown, the second circumferential positioning pin 40 is wrapped at least half a circle (for example, half a circle) in the counterclockwise direction, and then the third circumferential positioning pin 40 is continued to move along the first winding direction; when the third circumferential positioning pin 40 is reached, the third circumferential positioning pin 40 is wrapped at least half a circle (for example, half a circle) and then the fourth circumferential positioning pin 40 is continued to move along the first winding direction toward the first circumferential positioning pin 40; when the fourth circumferential positioning pin 40 is reached, the fourth circumferential positioning pin 40 is wrapped at least half a circle (for example, half a circle) and then the first circumferential positioning pin 40 is continued to move along the first winding direction until it returns to the second starting point. Repeat the above steps to weave the second second wire and the third second wire, wherein the second second wire can be wrapped around each circumferential positioning pin 40 at least one and a half circles (for example, one and a half circles) in the clockwise or counterclockwise direction, and the third second wire can be wrapped around each circumferential positioning pin 40 at least one and a half circles (for example, one and a half circles) in the counterclockwise or clockwise direction, and the third second wire can be wrapped around each circumferential positioning pin 40 at least one and a half circles (for example, one and a half circles) in the counterclockwise direction. Fig. 9 The clockwise direction shown is wound around each circumferential locating pin 40 for at least half a turn (eg, half a turn).

[0082] The number of turns of the second wire material around the circumferential surface positioning pin 40 near the first side surface 20a1 or the second side surface 20a2 is half a turn, and the number of turns of the second wire material around the circumferential surface positioning pin 40 in the middle of the circumferential surface 20a3 is one and a half turns. This arrangement can avoid the length and height of the olfactory cleft stent 10 being too large due to too many turns of wire material.

[0083] The number of the second wires can be 2 to 5. When the number of the second wires is 2, the number of turns of the two second wires around the circumferential surface positioning pins 40 is half a turn; when the number of the second wires is 3, the number of turns of the two outermost second wires around the circumferential surface positioning pins 40 is half a turn, and the number of turns of the middle second wire around the circumferential surface positioning pins 40 is one and a half turns; when the number of the second wires is 4, the number of turns of the two outermost second wires around the circumferential surface positioning pins 40 is half a turn, and the number of turns of the two middle second wires around the circumferential surface positioning pins 40 is one and a half turns; when the number of the second wires is 5, the number of turns of the two outermost second wires around the circumferential surface positioning pins 40 is half a turn, and the number of turns of the three middle second wires around the circumferential surface positioning pins 40 is one and a half turns, or the number of turns of the four outermost second wires around the circumferential surface positioning pins 40 is half a turn, and the number of turns of the middle second wire around the circumferential surface positioning pins 40 is one and a half turns.

[0084] See also Figure 3 The circumferential surface 20a2 is sequentially provided with a plurality of annular grooves 20b arranged along the circumference of the braiding tool 20 in the axial direction, and the second wire can move in the corresponding annular grooves 20b. The setting direction of the annular grooves 20b is consistent with the winding direction of the second wire, which can ensure that the corresponding second wire can move along the preset winding direction.

[0085] It can be understood that the number of the annular grooves 20b is the same as the number of the second wires.

[0086] The depth of the annular groove 20b can be 0.3 to 0.7 times, for example, 0.3, 0.4, 0.5, 0.6 or 0.7 times the diameter of the second wire. This arrangement can ensure that the second wire can move along the preset winding direction and facilitate the peripheral support 200 to be removed from the braiding tooling 20 after being shaped.

[0087] It should be noted that the peripheral support 200 can be woven before the side support 100 or after it.

[0088] After the peripheral support 200 is braided, it can be heat-set together with the braiding tooling 20, wherein the heat-setting temperature is between the glass transition temperature and the melting temperature of the second wire material, and the heat-setting time can be determined according to the specific material of the second wire material, and can be set to 1 hour to 2 hours. After the peripheral support 200 is heat-set, it can be cooled together with the braiding tooling 20, wherein the cooling time is 0.5 hours to 1 hour, and the cooling temperature is -30°C to -10°C. Then, the peripheral positioning pin 40 is removed from the braiding tooling 20 to remove the peripheral support 200.

[0089] After the peripheral support 200 is heat-set, the winding portions of the second wires corresponding to the same peripheral positioning pin 40 can be connected together by welding, bonding or the like.

[0090] For step S300, the shaped side bracket 100 and the shaped peripheral bracket 200 can be connected by laser welding or bonding. Among them, medical implant grade glue (such as α-octyl cyanoacrylate medical glue) can be used for bonding, or implantable polymer glue (such as lactide-caprolactone copolymer, polycaprolactone, gelatin, etc.) can also be used. Of course, a polymer solution prepared by a polymer and a solvent can also be used, wherein the solvent evaporates and solidifies.

[0091] Some of the inflection points on the side bracket 100 are fixedly connected to the peripheral bracket 200, so that the olfactory cleft bracket 10 can be deformed during the pressing and gripping process. The inflection points in the side bracket 100 that are not fixedly connected to the peripheral bracket 200 are arranged at the same position on the olfactory cleft bracket 10 as the force-bearing position of the olfactory cleft bracket 10. The number of inflection points in the side bracket 100 that are not fixedly connected to the peripheral bracket 200 can be two, and these two inflection points are symmetrically arranged.

[0092] In summary, the olfactory cleft stent 10 obtained by the above-mentioned preparation method can have a certain expansion effect on the olfactory cleft after the stent is unfolded, which can reduce the situation where gas molecules cannot reach the olfactory area and bind to the olfactory receptors due to inflammatory swelling of the olfactory mucosa, polyps, nasal secretion blockage, etc., increase the patency of the olfactory cleft, and can also coat the drug on the surface of the stent so that the drug can be accurately and slowly released to the olfactory cleft, making up for the current systemic treatment of oral hormones, antibiotics and other drugs in clinical practice; in addition, the stent can also be set to a degradable material, without the need for a second surgery to remove it. It can be seen that the olfactory cleft stent 10 can effectively treat inflammatory lesions related to the olfactory cleft area, such as rhinitis, mild olfactory cleft polyps and other diseases.

[0093] On the other hand, see Figure 4 An embodiment of the present application further provides an olfactory cleft stent 10, which includes a circumferential support 200 and two side supports 100, wherein the two side supports 100 are respectively arranged at the axial ends of the circumferential support 10 and are both connected to the circumferential support 200.

[0094] Among them, the side bracket 100 and the peripheral bracket 200 can be prepared by using the above-mentioned preparation method.

[0095] The olfactory cleft stent 10, by setting the lateral branch 100 to be planar and the circumferential stent 200 to be annular, makes the lateral stent 100 fit the length and height of the olfactory cleft area, and the circumferential stent 200 fits the width of the olfactory cleft area, thereby improving the stability of the olfactory cleft stent 10 after being implanted in the olfactory cleft area of ​​the patient's nasal cavity. Then, after the olfactory cleft stent 10 is unfolded, it can have a certain expansion effect on the olfactory cleft, which will reduce the situation that the gas molecules cannot reach the olfactory area and bind to the olfactory receptors due to inflammatory swelling of the olfactory mucosa, polyps, nasal secretion blockage, etc., increase the patency of the olfactory cleft, and can also cover the drug on the surface of the stent, so that the drug can be accurately and slowly released to the olfactory cleft, making up for the current systemic treatment of oral hormones, antibiotics and other drugs in clinical practice; in addition, the stent can also be set to a degradable material, without the need for secondary surgery to remove it. It can be seen that the olfactory cleft stent 10 can effectively treat inflammatory lesions related to the olfactory cleft area, such as rhinitis, mild olfactory cleft polyps and other diseases.

[0096] In some embodiments of the present application, a drug layer is provided on the surface of the peripheral support 100 and / or the side support 200. The drug layer is provided on the olfactory cleft support 10 to achieve targeted point drug delivery and prevent possible side effects of systemic oral drugs such as those for treating olfactory cleft inflammation.

[0097] The drug layer may be disposed on the surface of the peripheral support 100 and / or the side support 200 by coating.

[0098] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0099] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A method for preparing an olfactory cleft stent, It is characterized in that The preparation method comprises: A side bracket is woven into a planar shape using the first wire material; A second wire material is used to weave into a ring-shaped peripheral bracket; The side bracket is connected to the peripheral bracket as a whole, and the side bracket is located at the axial end of the peripheral bracket.

2. The preparation method according to claim 1, It is characterized in that The side bracket and the peripheral bracket can be woven by a woven tool, the woven tool has a first side surface and a second side surface that are arranged opposite to each other and a circumferential surface connected to the first side surface and the second side surface, a plurality of side positioning pins are arranged on the first side surface and / or the second side surface, and a plurality of peripheral positioning pins are arranged on the circumferential surface; The braiding step of the side bracket and the peripheral bracket includes: Moving the first wire material on the first side or the second side of the braiding tool, and winding the first wire material around the side positioning pin during the movement to braid and form a side bracket; The second wire material is moved on the circumferential surface of the braiding tool, and is wound around the circumferential surface positioning pins during the movement to weave into a circumferential surface bracket.

3. The preparation method according to claim 2, It is characterized in that The side positioning pins are arranged in sequence along the edge of the first side surface or the second side surface; The side bracket is a grid-shaped bracket; the weaving step of the side bracket includes: taking any of the side positioning pins as a first starting point, and making the first wire material bend and move repeatedly in a hook shape between the side positioning pins until it returns to the first starting point.

4. The preparation method according to claim 3, It is characterized in that The number of the side positioning pins is 2m+2, and the first wire material can be woven into m quadrilateral meshes after being wound around all the side positioning pins, wherein m is an integer greater than or equal to 1.

5. The preparation method according to claim 3, It is characterized in that The distance between the side positioning pin and the edge of the first side surface or the second side surface is 1 to 1.5 times the wire diameter of the first wire material.

6. The preparation method according to claim 2, It is characterized in that The circumferential positioning pins are arranged at intervals along the circumference of the braiding tool, the number of the second wire materials is multiple, and the braiding steps of the circumferential support include: A plurality of the second wires are moved side by side on the circumferential surface along the circumference of the braiding tool until they are wound on the circumferential surface for at least one circle, wherein all the second wires are wound around each circumferential surface positioning pin when passing through each circumferential surface positioning pin.

7. The preparation method according to claim 6, It is characterized in that The braiding steps of the peripheral support include: Any position of the circumferential surface is used as the second starting point, and one of the second wires is moved on the circumferential surface with the circumference of the braiding tool as the winding direction. When passing through each circumferential surface positioning pin, the second wire is wrapped around the circumferential surface positioning pin for at least half a circle, and then continues to move in the original winding direction until it returns to the second starting point; repeat the above steps to weave the remaining second wires.

8. The preparation method according to claim 6, It is characterized in that The second wire material close to the first side surface or the second side surface is wound around the circumferential surface positioning pin half a circle, and the second wire material located in the middle of the circumferential surface is wound around the circumferential surface positioning pin one and a half circles.

9. The preparation method according to claim 6, It is characterized in that The circumferential surface is sequentially provided with a plurality of annular grooves along the circumference of the braiding tool in the axial direction, and the second wire material can move in the corresponding annular grooves.

10. The preparation method according to claim 9, It is characterized in that The depth of the annular groove is 0.3 to 0.7 times the wire diameter of the second wire material.

11. The preparation method according to any one of claims 2 to 10, It is characterized in that The length L of the braided tooling is 25 mm to 30 mm, the width W is 1.5 mm to 3 mm, and the height H is 28 mm to 32 mm; and / or, the first wire material and the second wire material are degradable materials or non-degradable materials.

12. An olfactory cleft stent, It is characterized in that It comprises an annular peripheral support and two planar side supports, wherein the two side supports are respectively arranged at the axial ends of the peripheral support and are both connected to the peripheral support.

13. The olfactory cleft stent according to claim 12, It is characterized in that The peripheral support and the side support are prepared by the preparation method according to any one of claims 1 to 11.

14. The olfactory cleft stent according to claim 12, It is characterized in that A drug layer is provided on the surface of the peripheral support and / or the side support.

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