A device and method for manufacturing a medical hollow catheter

Abstract

The application discloses a preparation device and a preparation method of a medical hollow catheter. The preparation device comprises a template preparation assembly, a tube wall preparation assembly, a post-processing assembly and a horizontal support. The tube wall preparation assembly is used for coating a tube wall preparation demoulding pre-catheter on an inner core template. The post-processing assembly is used for performing cross-linking, demoulding, cutting and sterilization operations on the demoulding pre-catheter to prepare the medical hollow catheter. The horizontal support is arranged between the template preparation assembly and the tube wall preparation assembly and comprises a moulding area and a wall preparation area. The template preparation assembly, the tube wall preparation assembly and the post-processing assembly are sequentially arranged. The preparation device is used for realizing micron-level precision control in the preparation process. The micron-sized template filaments are used for introducing biopolymers with excellent biocompatibility and processability into the medical hollow catheter structure, so that the stimulation of the material on the injured tissue is greatly reduced, the repair of the human body wound is facilitated, and the preparation device has a good application prospect in the field of human body wound effusion drainage and tissue repair.

Description

Technical Field

[0001] This invention relates to the field of biomedical materials technology. More specifically, it relates to an apparatus and method for preparing a medical hollow catheter. Background Technology

[0002] Injuries to human organs and wear and tear on joints inevitably lead to fluid accumulation, which is also an unavoidable phenomenon during internal surgeries. Common types of fluid accumulation include aqueous humor effusion, spinal effusion, intracranial effusion, ascites, pleural effusion, and joint effusion. Fluid accumulation in these organs can not only worsen the condition of injured tissues but also cause nerve damage, and in severe cases, endanger life.

[0003] Therefore, it is necessary to develop appropriate drainage devices for draining effusion. Traditional drainage devices, such as glaucoma drainage valves, integrated peripancreatic drainage tubes, and negative pressure drainage devices for the spine, typically have the following drawbacks: 1) Their complex structures not only lead to inconvenience during drainage operations but also affect the patient's daily life; 2) Their fixed specifications do not take into account the complexity of internal drainage. During drainage, if the effusion is not completely drained, it can lead to a certain degree of infection in the wounded tissue; if the effusion is completely drained, a large negative pressure is required, which can cause secondary damage to the wounded tissue and is not conducive to wound healing; 3) Current drainage devices are usually relatively macroscopic, which means that the drainage wound is larger, posing a risk of tissue infection. Furthermore, the development of fine and miniature drainage devices has encountered significant bottlenecks due to the high requirements for local uniformity.

[0004] Tissue repair aims to repair local tissue and cell damage and death caused by accidents, trauma, and other related factors. Ideally, tissue defects are completely repaired by cells of the original nature, restoring the original structure and function. Currently, the most common method of tissue repair is autologous transplantation, which has advantages such as no immunogenicity, high bioactivity, and suitable mechanical properties. However, autologous transplantation also has many limitations that affect its application, such as the susceptibility of donor sites to disease and the limited number of donors.

[0005] With the development of medical preparation equipment technology, some medical material preparation equipment has emerged. It can prepare some drainage materials and tissue repair materials with lower requirements. However, it cannot be used or can hardly meet the requirements under some special medical conditions. In addition, it also faces problems such as low precision of preparation equipment, cumbersome operation and long preparation cycle. There is still no ideal preparation device for micron-sized medical drainage materials and tissue repair materials. Therefore, it is urgent to develop a preparation device that can be precisely controlled, easy to operate and highly automated to solve the above problems. Summary of the Invention

[0006] One objective of this invention is to provide a device for preparing medical hollow catheters, which achieves micron-level precise control during the preparation process, is easy to operate, and has a high degree of automation.

[0007] Another objective of this invention is to provide a method for preparing medical hollow catheters using the above-mentioned preparation device. This method employs the micron-level precision control technology of the above-mentioned special device to prepare medical hollow catheters with good biocompatibility. The preparation process is simple and can be continuously produced.

[0008] To achieve the first objective mentioned above, the present invention adopts the following technical solution:

[0009] This invention provides an apparatus for preparing a medical hollow catheter, comprising:

[0010] Template preparation component for providing the inner core template for medical hollow catheters;

[0011] A tube wall preparation assembly is used to coat the outer wall of an inner core template to prepare a pre-demolding conduit.

[0012] The post-processing component is used to cross-link, demold, and cut the catheter before demolding to prepare a medical hollow catheter.

[0013] And a horizontal support running between the template preparation assembly and the tube wall preparation assembly;

[0014] The horizontal support includes a molding area and a wall forming area. The template preparation component, the pipe wall preparation component, and the post-processing component are arranged sequentially. The template preparation component is located in the molding area of ​​the horizontal support, and the pipe wall preparation component is located in the wall forming area of ​​the horizontal support.

[0015] Furthermore, the template preparation component includes

[0016] Template disk, used to provide template filaments;

[0017] The first transfer gripping component is used to grip, pull, and transfer the template filament;

[0018] Release agent coating assembly for coating the outer surface of template filaments with release agent;

[0019] And a cutting component for cutting the pulled-out template filaments;

[0020] The outlet end of the template disk is connected to the coaxial positioning hole of the mold release agent coating component, and the coaxial positioning hole is connected to one end of the horizontal support. The first transmission gripping component is located above the molding area of ​​the horizontal support, and the cutting component is located outside the molding area of ​​the horizontal support.

[0021] Furthermore, the pipe wall preparation assembly includes an adhesive gripping assembly; a sol-sol circulation system; a circulating heat preservation system; and a sol-sol convex surface generation assembly;

[0022] The adhesive gripping component is configured to grip the inner core template for adhesive application; the solvent circulation system is configured to stably supply the solvent, the solvent circulation system including an outer circulation tank, an inner circulation tank, and a circulation storage tank; the circulation insulation system is configured to maintain the temperature of the solvent, the circulation insulation system including an insulation container and a water circulation insulation component, the insulation container being connected to the water circulation insulation component via piping; the solvent convex surface generating component is configured to form a convex surface of the solvent in the inner circulation tank.

[0023] Furthermore, the post-processing assembly includes a porous stainless steel rack for holding the pre-demolding conduit; a stainless steel tank for holding a crosslinking liquid to achieve crosslinking treatment of the pre-demolding conduit; and a second transfer gripping assembly configured to transfer the pre-demolding conduit.

[0024] To achieve the aforementioned other objective, the present invention adopts the following technical solution:

[0025] This invention provides a method for preparing medical hollow catheters using the above-described preparation apparatus, comprising the following steps:

[0026] The template filament is drawn out from the template plate, passes through the coaxial positioning hole of the release agent coating component, and is pulled out horizontally along the horizontal support molding area by the first transmission gripping component. At the same time as the template filament is pulled out, the release agent is applied at the coaxial positioning hole. After being cut by the cutting component, the inner core template is obtained.

[0027] Then the first transfer gripping component grips the template filament to the horizontal support wall-making area, and the adhesive gripping component grips the template filament and lowers it, so that the outer surface of the template filament is immersed in the inner circulation tank containing the sol solution, and under the action of the adhesive gripping component, it undergoes multiple immersion, leaching, rotation and oscillation to prepare a pre-demolding conduit coated with sol solution.

[0028] Then, the adhesive gripping component is controlled to grip the pre-demolding catheter and move it to the horizontal support wall-making area. The second transfer gripping component replaces the adhesive gripping component to grip the pre-demolding catheter onto the porous stainless steel tray. The porous stainless steel tray is then transferred to a stainless steel tank containing a crosslinking agent solution for crosslinking. After crosslinking, the catheter is demolded, cut, and finally a medical hollow catheter is obtained.

[0029] Furthermore, the raw materials of the sol solution include biopolymers, additives, pharmaceutical components, and emulsifiers. The amount of biopolymers added is 1-100 wt%, the amount of additives added is 0-40 wt%, the amount of pharmaceutical components added is 0-40 wt%, and the amount of emulsifier added is 0-20 wt%.

[0030] Furthermore, the biopolymers include, but are not limited to, type I collagen, gelatin, chitosan, chitosan oligosaccharide, sodium carboxymethyl cellulose, collagen, glycosaminoglycans, alginate, hydroxymethyl chitosan, polycaprolactone, chitosanamine, bioactive glass micro / nano powders, lecithin, hyaluronic acid, silk protein, chondroitin sulfate, heparin, nucleic acid, cellulin, serum fibronectin, polypeptides, agar, various dextran, polyhydroxybutyrate, polyhydroxybutyrate, polycaprolactone, polyglycolic acid, polylactide, polylactic acid, poly(p-dioxanone), polyurethane, polyphosphate, polyoxyethylene, lactide, glycolide, butyllactide, valerate, glycolide, ethylene oxide, propylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, ethyl cellulose, amorphous cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, cellulose acetate, starch, ethyl starch, and methyl starch, or one or more of these.

[0031] Furthermore, the additives include, but are not limited to, one or more of the following: sodium chloride, calcium chloride, glycerol, polyvinyl alcohol, polyethylene glycol, ethyl carbodiamine, isohexyl dicyanate, diphenylphosphine azide, sorbitol, hydroxyapatite, β-calcium phosphate, potassium titanate whiskers, potassium chromate, calcium carbonate, calcium citrate, calcium oxalate, calcium hydrogen phosphate, calcium dihydrogen phosphate, and dimethyl silicone oil.

[0032] Furthermore, the emulsifier includes, but is not limited to, one or more of glyceryl monostearate, propylene glycol stearate, polyglycerol fatty acid ester, sorbitol, and Tween.

[0033] In this invention, the pharmaceutical components include, but are not limited to, ethamsylate, mupirocin, gentamicin sulfate, dexamethasone sodium, tinidazole, clindamycin hydrochloride, Panax notoginseng, indigo naturalis, pearl powder, Yunnan Baiyao, cattail pollen, tea polyphenols, tannins, silver chloride, micro / nano titanium dioxide, micro / nano zinc oxide, micro / nano silica, micro / nano silver, berberine, organic acid antibacterial agents, quaternary ammonium salts, biguanide antibacterial agents, sulfadiazine, sulfamethoxazole-trimethoprim, norfloxacin, ciprofloxacin, ofloxacin, 5-fluorouracil, 1-5-fluorouracil acetate, mitomycin C, daunorubicin, 6-mercaptopurine, pyrimidine or cyclosporine, antimycobacterial drugs, anti-inflammatory drugs, antibiotics, antiviral drugs, anti-infective drugs, radiation drugs, immunomodulatory agents, analgesics, and anti-allergic drugs, and the pharmaceutical components also include, for example, extracts of effective components for treating diseases extracted from one or more of traditional Chinese medicine, Tibetan medicine, Mongolian medicine, and Miao medicine.

[0034] Furthermore, the melting temperature is 0–160°C; the heat preservation temperature is 10–95°C.

[0035] Furthermore, the mass concentration of the sol solution is 0.1-60 wt%; the solvent includes, but is not limited to, one or more of water, formic acid, acetic acid, hydrochloric acid, salicylic acid, aqueous ethanol solution, benzoic acid, urea, thiourea, aqueous potassium bromide solution, aqueous sodium chloride solution, glycerol, dichloromethane, tetrahydrofuran, trifluoroethanol, and hexafluoroisopropanol.

[0036] Furthermore, the release agent includes, but is not limited to, one or more of the following: diesel oil, gasoline, engine oil, capsule oil, cottonseed oil, soybean oil, peanut oil, rapeseed oil, sunflower seed oil, corn germ oil, and olive oil.

[0037] Furthermore, the crosslinking agent includes, but is not limited to, one or more of the following: glutaraldehyde, carbodiimide, genipin, divinyl sulfone, formaldehyde, glyoxal, malondialdehyde, succinaldehyde, hexadialdehyde, heptaldehyde, octaldehyde, nonanaldehyde, decanal, glucose, dialdehyde glucose, dextran, oxidized glucose, oxidized dextran, diepoxide, and divinyl sulfone.

[0038] Furthermore, the solvent of the crosslinking agent includes, but is not limited to, one or more of water, ethanol, formic acid, acetic acid, hydrochloric acid, salicylic acid, aqueous ethanol solution, benzoic acid, urea, thiourea, aqueous potassium bromide solution, aqueous sodium chloride solution, glycerol, dichloromethane, and tetrahydrofuran. The concentration of the crosslinking agent solution is 0.0001–60 wt%, and the crosslinking temperature is 15–45 °C.

[0039] Furthermore, the template filaments include, but are not limited to, one of the following: steel wire, copper wire, iron wire, nickel wire, lead wire, gut yarn, nylon yarn, polyester yarn, polyglycolic acid yarn, polyethylene yarn, polyester yarn, polydioxane yarn, polydioxane ketone yarn, and polyglycolic acid yarn, wherein the diameter of the template filaments is 30-5000 μm.

[0040] The beneficial effects of this invention are as follows:

[0041] This invention discloses a device and method for preparing a medical hollow catheter, comprising a template preparation component for providing an inner core template for the medical hollow catheter; a tube wall preparation component for coating the inner core template with a tube wall to prepare a pre-demolding catheter; a post-processing component for cross-linking, demolding, and cutting the pre-demolding catheter to prepare the medical hollow catheter; and a horizontal support penetrating between the template preparation component and the tube wall preparation component, the horizontal support including a molding area and a wall preparation area, wherein the template preparation component, the tube wall preparation component, and the post-processing component are arranged sequentially. The device enables micron-level precision control during the preparation process, utilizing micron-sized template filaments to introduce biocompatible and highly processable biopolymers into the structure of the medical hollow catheter, thereby greatly reducing the irritation of the material to the injured tissue and facilitating the repair of human wounds. It has promising application prospects in the fields of wound drainage and tissue repair. Through the coordinated control of self-developed preparation equipment and preparation process, hollow conduits with good uniformity and smooth inner and outer surfaces can be prepared. The outer diameter of the hollow conduits is 100-10000μm, the inner diameter is 30-5000μm, and the length is 4.00-120.00mm, with deviations of <±3.5%. Attached Figure Description

[0042] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0043] Figure 1 A schematic diagram of the preparation device of the present invention and a corresponding enlarged view are shown.

[0044] Figure 2 A schematic diagram of the preparation apparatus of the present invention is shown.

[0045] Figure 3 A schematic diagram of the hollow conduit of Embodiment 3 of the present invention is shown.

[0046] In the diagram: 1 First pneumatic gripper for transmission, 2 Second pneumatic gripper for transmission, 3 Template sensor, 4 Release agent storage tank, 5 Clamping sponge, 6 Horizontal support, 7 First adhesive pneumatic gripper, 8 Second adhesive pneumatic gripper, 9 Template plate fixing support, 10 Template plate, 11 Cutting knife, 12 Auxiliary pneumatic gripper support, 13 Auxiliary pneumatic gripper, 14 External circulation tank, 15 Internal circulation tank, 16 Insulated container, 17 Sol-gel tank circulation pipeline, 18 Sol-gel liquid circulation pump, 19 Circulation storage tank, 20 Water circulation pipeline, 21 Water circulation pump, 22 Water storage tank, 23 Third pneumatic gripper for transmission, 24 Fourth pneumatic gripper for transmission, 25 Perforated stainless steel trough frame, 26 Stainless steel trough, 27 Stainless steel roller, 28 Drive belt, 29 Drive bearing, 30 Rotary motor, 31 Cutting knife fixing support, 32 Coaxial positioning hole. Detailed Implementation

[0047] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments and accompanying drawings, further explains the invention. Similar components in the drawings are indicated by the same reference numerals. Those skilled in the art should understand that the specific description below is illustrative rather than restrictive and should not be construed as limiting the scope of protection of the present invention.

[0048] According to one objective of the present invention, the present invention first provides a device for preparing a medical hollow catheter, combined with... Figure 1 As shown, the preparation device includes a template preparation component for providing an inner core template for a medical hollow catheter; a tube wall preparation component for coating the inner core template with a tube wall to prepare a pre-demolding catheter; a post-processing component for cross-linking, demolding, cutting, and sterilizing the pre-demolding catheter to prepare a medical hollow catheter; and a horizontal support penetrating between the template preparation component and the tube wall preparation component. The horizontal support includes a molding area and a wall preparation area. The template preparation component, the tube wall preparation component, and the post-processing component are arranged sequentially. The template preparation component is located in the molding area of ​​the horizontal support, and the tube wall preparation component is located in the wall preparation area of ​​the horizontal support.

[0049] In one embodiment, the template preparation component includes a template disk for providing template filaments;

[0050] The first transfer gripping component is used to grip, pull, and transfer the template filament;

[0051] Release agent coating assembly for coating the outer surface of template filaments with release agent;

[0052] And a cutting component for cutting the pulled-out template filaments;

[0053] Depend on Figure 1 As shown in (B), the outlet end of the template disk is connected to the coaxial positioning hole of the release agent coating component, the coaxial positioning hole is connected to one end of the horizontal support, the first transmission gripping component is located above the molding area of ​​the horizontal support, and the cutting component is located outside the molding area of ​​the horizontal support.

[0054] In one embodiment, the tube wall preparation assembly includes an adhesive gripping assembly; a sol-sol circulation system; a circulating insulation system; and a sol-sol convex surface generation assembly.

[0055] Depend on Figure 1As shown in (C), the adhesive gripping component is configured to grip the inner core template for adhesive application; the solvent circulation system is configured to stably supply the solvent, the solvent circulation system including an outer circulation tank, an inner circulation tank, and a circulation storage tank; the circulation insulation system is configured to maintain the temperature of the solvent, the circulation insulation system including an insulation container and a water circulation insulation component, the insulation container being connected to the water circulation insulation component via piping; the solvent convex surface generating component is configured to form a convex surface of the solvent in the inner circulation tank.

[0056] The sol-gel convex surface generating assembly includes a stainless steel roller located in the inner circulation tank, a transmission bearing located outside the insulation container, a transmission belt, a rotating motor, and a matching waterproof flange.

[0057] In one embodiment, the post-processing assembly includes a porous stainless steel rack for holding the pre-demolding conduit; a stainless steel tank for holding a crosslinking liquid to achieve crosslinking treatment of the pre-demolding conduit; and a second transfer gripping assembly configured to transfer the pre-demolding conduit.

[0058] In this invention, a template sensor is installed directly below the outlet end of the template disk. The template sensor ensures effective sensing of the stretching and cutting of the template filaments, preventing system idling due to cutting failure. The transmission and gripping assembly is a key component for stretching, gripping, and transferring the template filaments, preventing radial bending and deformation of the template filaments on the horizontal support due to excessive or uneven force. The release agent coating assembly includes a release agent storage tank, nylon bearings, and clamping sponges. The release agent storage tank stores different release agents or release liquids. The clamping sponges are used to uniformly coat the intermediate template filaments with release agent after the template filaments pass through the coaxial positioning holes of the nylon bearings. The clamping sponges are connected to the release agent storage tank, allowing for continuous supply of release agent via a siphon effect. A guide rail is installed on the horizontal support, allowing the transmission and gripping assembly and the adhesive gripping assembly to slide on the guide rail.

[0059] The first transmission gripping component includes a first transmission pneumatic gripper and a second transmission pneumatic gripper. The adhesive gripping component includes a first adhesive pneumatic gripper and a second adhesive pneumatic gripper. The second transmission gripping component includes a third transmission pneumatic gripper and a fourth transmission pneumatic gripper, all of which can operate synchronously. The first and second transmission pneumatic grippers are fixed to the molding area of ​​the horizontal support with guide rails, and the relative distance between the first and second transmission pneumatic grippers is fixed. The relative distance between the first and second adhesive pneumatic grippers is also fixed. The relative distance between the third and fourth transmission pneumatic grippers is also fixed. When the template filament is cut, it is transmitted to the corresponding first and second adhesive pneumatic grippers through adjustment. The distance between the first and second transmission pneumatic grippers is not less than the distance between the first and second adhesive pneumatic grippers.

[0060] The template tray fixing bracket is used to fix the template tray and is located at the front end of the entire device. The cutting component includes a cutting blade fixing bracket and a cutting blade. The cutting blade fixing bracket is a dynamic cutting fixing frame, whose main function is to fix the cutting blade and dynamically cut the template filaments using compressed air. The auxiliary pneumatic gripper bracket is a fixing frame for the auxiliary pneumatic gripper, whose main function is to ensure the balance and stability of the auxiliary pneumatic gripper. The auxiliary pneumatic gripper can provide a transfer for conveying template fibers.

[0061] The present invention includes two sets of heat preservation and circulation systems, one set of sol liquid circulation system and the other set of water circulation system. These two sets of circulation systems can achieve two functions: (1) the sol liquid continuously circulates from the circulation storage tank - sol liquid circulation pump - inner circulation tank - outer circulation tank - circulation storage tank to achieve uniform temperature balance; (2) through the circulation of water storage tank - water circulation pump - heat preservation container - water storage tank, the temperature of the sol in the inner and outer circulation tanks is maintained to achieve uniform temperature distribution of the sol liquid surface.

[0062] In the present invention, a set of sol convex surface generating components is included, which includes a stainless - steel roller located in the inner circulation tank, a transmission bearing outside the heat - preservation container, a transmission belt, a rotating motor, and a supporting waterproof flange. The stainless - steel rollers in the inner circulation tank are two relatively - arranged stainless - steel rollers. In the present application, the diameter of the stainless - steel roller is 5 cm, and those skilled in the art can adjust the diameter of the stainless - steel roller according to the actual situation. The rotation directions of the two stainless - steel rollers are opposite, making the stainless - steel rollers drive the viscose to have an upward trend, thus forming an upward laminar flow from the roller surface to between the two stainless - steel rollers, and then generating a dynamic - balance convex surface in the inner circulation tank. The convex surface causes the liquid level to be higher than the wall of the inner circulation tank, and part of the viscose will flow into the outer circulation tank. The viscose in the outer circulation tank will be sucked into the inner circulation tank under the action of the stainless - steel rollers, thus completing the whole cycle. Its existence mainly serves two functions: (1) driven by the stainless - steel rollers, the sol in the inner circulation tank surges evenly, giving the inner circulation tank a stable and dynamic viscose convex surface for the immersion and dipping of the template filaments; (2) due to the existence of the viscose convex surface, the viscose gripper does not need to be immersed in the viscose, and the template filaments can complete the dipping of the viscose, which lays a solid foundation for the continuous operation of the device.

[0063] In the present application, the inventors found through a large number of experiments that by controlling the viscose process parameters, it is beneficial to prepare a medical hollow catheter with uniform wall thickness. When the viscose time (d) is 1 < d < 60 s and the number of times of immersing and leaching the sol liquid (N) is 0 < N < 50 times, the above - mentioned effect can be achieved. Further, the template filaments can perform movements such as rotation and swing in the sol liquid. The rotation speed (M) is 0 < M < 1000 rpm, the swing amplitude (X) is 0 < X < 60°, the swing frequency (Y) is 0 < Y < 50 HZ, and the total time (Z) of rotation and swing is 5 < Z < 600 s. Those skilled in the art can understand that the movement modes include any combination of immersion, leaching, rotation, and swing, as long as the effects of sufficient viscose and uniform viscose can be achieved.

[0064] The medical hollow catheter prepared by the present invention is expected to have important research value and application prospects in the fields of human tissue fluid drainage and tissue repair, such as aqueous humor drainage, cerebrospinal fluid drainage, cranial cavity effusion drainage, pleural effusion drainage, peritoneal effusion drainage, joint effusion drainage, capillary repair, nerve conduction repair, nasal cartilage repair, etc.

[0065] According to another object of the present invention, the present invention also provides a preparation method for preparing a medical hollow catheter using the above - mentioned preparation device. Specifically, the method includes the following steps:

[0066] The template filament is drawn out from the template plate, passes through the coaxial positioning hole of the release agent coating component, and is pulled out horizontally along the horizontal support molding area by the first transmission gripping component. At the same time as the template filament is pulled out, the release agent is applied at the coaxial positioning hole. After being cut by the cutting component, the inner core template is obtained.

[0067] Then the first transfer gripping component grips the template filament to the horizontal support wall-making area, and the adhesive gripping component grips the template filament and lowers it, so that the outer surface of the template filament is immersed in the inner circulation tank containing the sol solution, and under the action of the adhesive gripping component, it undergoes multiple immersion, leaching, rotation and oscillation to prepare a pre-demolding conduit coated with sol solution.

[0068] Then, the adhesive gripping component is controlled to grip the pre-demolding catheter and move it to the horizontal support wall-making area. The second transfer gripping component replaces the adhesive gripping component to grip the pre-demolding catheter onto the porous stainless steel tray. The porous stainless steel tray is then manually transferred to a stainless steel tank containing a crosslinking agent solution for crosslinking. After crosslinking, the catheter is demolded, cut, and finally a medical hollow catheter is obtained.

[0069] Optionally, the raw materials of the sol solution include biopolymers, additives, pharmaceutical components, and emulsifiers, wherein the amount of biopolymers added is 1-100 wt%, the amount of additives added is 0-40 wt%, the amount of pharmaceutical components added is 0-40 wt%, and the amount of emulsifier added is 0-20 wt%.

[0070] Optionally, the biopolymer is selected from one or more of type I collagen, gelatin, chitosan, chitosan oligosaccharide, sodium carboxymethyl cellulose, collagen, glycosaminoglycans, alginate, hydroxymethyl chitosan, polycaprolactone, or chitosan; preferably, the additive is selected from one or more of sodium chloride, calcium chloride, glycerol, polyvinyl alcohol, polyethylene glycol, ethyl carbodiimide, or isohexamethylenediamine; preferably, the emulsifier is selected from one or more of glyceryl monostearate, propylene glycol stearate, polyglycerol fatty acid ester, sorbitol, or Tween; preferably, the pharmaceutical component is selected from one or more of ethamsylate, mupirocin, gentamicin sulfate, dexamethasone sodium thiosulfate, tinidazole, clindamycin hydrochloride, Panax notoginseng, indigo naturalis, pearl powder, or Yunnan Baiyao.

[0071] Optionally, the dissolution temperature is 0–160°C; preferably, the heat preservation temperature is 10–95°C; preferably, the mass concentration of the sol solution is 0.1–60 wt%; preferably, the solvent is selected from one or more of water, formic acid, acetic acid, hydrochloric acid, salicylic acid, aqueous ethanol solution, benzoic acid, urea, thiourea, aqueous potassium bromide solution, aqueous sodium chloride solution, glycerol, dichloromethane, tetrahydrofuran, trifluoroethanol, or hexafluoroisopropanol.

[0072] Optionally, the release agent is selected from one or more of diesel oil, gasoline, engine oil, capsule oil, cottonseed oil, soybean oil, peanut oil, rapeseed oil, sunflower seed oil, corn germ oil, olive oil, etc.; the crosslinking agent is selected from one or more of glutaraldehyde, carbodiimide, genipin, divinyl sulfone, formaldehyde, glyoxal, malondialdehyde, succinaldehyde, adipaldehyde, heptaldehyde, octaldehyde, nonanaldehyde, sebacaldehyde, glucose, dialdehyde glucose, dextran, oxidized glucose, oxidized dextran, diepoxide, and divinyl sulfone; preferably, the crosslinking temperature is 15-45℃, and preferably, the concentration of the crosslinking agent is 0.0001-60wt%.

[0073] Optionally, the template filament includes, but is not limited to, one of the following: steel wire, copper wire, iron wire, nickel wire, lead wire, gut yarn, nylon yarn, polyester yarn, polyglycolic acid yarn, polyethylene yarn, polyester yarn, polydioxane yarn, polydioxane ketone yarn, and polyglycolic acid yarn; preferably, the diameter of the template filament is 30-5000 μm.

[0074] In this invention, through the coordinated control of a self-developed preparation device and preparation process, hollow conduits with good uniformity and smooth inner and outer surfaces can be prepared. The outer diameter of the hollow conduit is 100-10000 μm, the inner diameter is 30-5000 μm, and the length is 4.00-120.00 mm, with deviations of <±3.5%.

[0075] Example 1

[0076] In one specific embodiment, firstly, under clean conditions, chitosan with a molecular weight of 200,000-250,000 is placed in an acetic acid solution with pH=1 to swell and dissolve, forming a 3wt% chitosan solution. Then, 0.2wt% sorbitol and 0.01wt% ciprofloxacin are added to prepare a sol solution. The solution is then subjected to ultrasonic vibration for 30 minutes to remove air bubbles. The sol solution is then added to a circulating storage tank 19, and the sol solution circulation pump 18 is started to achieve dynamic circulation of the inner and outer circulation tanks at 30°C. The water storage tank 22 is then filled with water, and the water circulation pump 21 is started to achieve dynamic circulation of the insulated container 16 at T=34.5°C. A 300μm diameter stainless steel wire is led out from the template plate 10, passes through a nylon bearing, and provides a sensing signal to the template sensor 3. Capsule oil is used as a release agent. The stainless steel wire passes through the clamping sponge 5 and the corresponding coaxial positioning hole 32 after being coated with the release agent. The first pneumatic gripper 1 grips the stainless steel wire extending from the coaxial positioning hole 32 via pneumatic drive, while the second pneumatic gripper 2 simultaneously grips it without moving. Both grippers 1 and 2 move linearly to the right of the auxiliary pneumatic gripper 13 via electric drive. The auxiliary pneumatic gripper 13 closes to grip the stainless steel wire, and the first and second grippers 1 and 2 open. Then, the first and second grippers 1 and 2 rise along the guide rail of the horizontal support 6, move horizontally to the left, and then descend to a position where they can grip the stainless steel wire. The first and second grippers 1 and 2 pneumatically close to grip the stainless steel wire, and the cutting blade 11 cuts the stainless steel wire on the left side of the first pneumatic gripper 1, causing the auxiliary pneumatic gripper 13 to open. Subsequently, the first pneumatic gripper 1 and the second pneumatic gripper 2 move upward, then to the right, and then downward along the horizontal support 6, until they are level with the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8, and within their gripping range. Driven by gas, the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 grip the stainless steel wire. The first pneumatic gripper 1 and the second pneumatic gripper 2 open and return to their original positions. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 simultaneously move downward, adhesive, and upward while gripping the stainless steel wire. This process is repeated cyclically, accompanied by continuous rotation and oscillation of the gripper and the wire. The parameters are: d = 10s, N = 2, M = 50rpm, X = 15°, Y = 10Hz, and Z = 60s.After the stainless steel wire is evenly coated, the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 move up to near the guide rail. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24 move horizontally to the inside of the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8, and move down to a position where the gripping point can grasp the steel wire. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24 firmly grasp the stainless steel wire coated with adhesive. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 open and return to their original positions. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24... The four pneumatic grippers 24 move upwards synchronously, placing the stainless steel wire coated with adhesive into the porous stainless steel tray 25. The porous stainless steel tray 25 is then manually transferred to a stainless steel tank 26 containing 15% glutaraldehyde crosslinking solution for crosslinking at a temperature of 15°C. After crosslinking, the sample is removed, demolded, and cut to obtain a medical hollow catheter with an outer diameter of 450±10μm, an inner diameter of 300±3μm, and a length of 35.00±0.25mm. This medical hollow catheter can be used for the drainage of joint effusion.

[0077] Example 2

[0078] In another specific embodiment, firstly, under clean conditions, collagen with a molecular weight of 300,000-350,000 is placed in pure water at 60°C to swell and dissolve, forming an 18wt% collagen solution. Then, 0.5wt% calcium chloride and 0.1wt% Tween are added to prepare a homogeneous solution. Air bubbles are removed by ultrasonic vibration for 30 minutes. The sol solution is then added to the circulating storage tank 19, and the sol solution circulation pump 18 is started to achieve dynamic circulation of the internal and external circulation tanks at 45°C. The water storage tank 22 is filled with water, and the water circulation pump 21 is started to achieve dynamic circulation of the insulated container 16 at T=48°C. Nylon threads with a diameter of 500μm are led out from the template disc 10, pass through a nylon bearing, and provide a sensing signal to the template sensor 3. Capsule oil is used as a release agent. The nylon threads are then passed through the clamping sponge 5 and the corresponding coaxial positioning holes 32 after being coated with the release agent. The first pneumatic gripper 1 grips the nylon thread extending from the coaxial positioning hole 32 via pneumatic drive. Simultaneously, the second pneumatic gripper 2 grips without moving. Both grippers 1 and 2 move linearly to the right of the auxiliary pneumatic gripper 13, which closes to secure the nylon thread. The first and second grippers 1 and 2 then open. Next, the first and second grippers 1 and 2 rise along the guide rail of the horizontal support 6, then move horizontally to the left, and finally descend to a position where they can grip the nylon thread. The first and second grippers 1 and 2 then pneumatically close to secure the nylon thread. The cutting blade 11 cuts the nylon thread on the left side of the first gripper 1, and the auxiliary pneumatic gripper 13 opens. Subsequently, the first transmission pneumatic gripper 1 and the second transmission pneumatic gripper 2 move upward, then to the right, and then downward along the horizontal support 6, until they are level with the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8, and within their gripping range. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 grip firmly under gas drive. The first transmission pneumatic gripper 1 and the second transmission pneumatic gripper 2 open and reset. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 grip the nylon thread and move downward, adhesive, and upward synchronously, repeating the entire process. During this cycle, the grippers and the nylon thread continuously rotate and swing. The parameters are: d = 30s, N = 5, M = 150rpm, X = 45°, Y = 20Hz, and Z = 300s.After the nylon thread is evenly coated, the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 move up to the vicinity of the guide rail. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24 move horizontally to the inside of the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8, and move down to a position where the gripping point can grasp the nylon thread. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24 firmly grasp the stainless steel wire coated with adhesive. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 open and return to their original positions. Hand 23 and the fourth pneumatic gripper 24 move upwards synchronously, placing the stainless steel wire coated with adhesive into the porous stainless steel tray 25, and manually transferring it to the stainless steel tank 26 containing 10% carbodiimide crosslinking solution for crosslinking at a temperature of 35°C. After crosslinking, the sample is removed, demolded, and cut to obtain a medical hollow catheter with an outer diameter of 600±10μm, an inner diameter of 500±3μm, and a length of 50.00±0.25mm. This medical hollow catheter can be used for the repair of damaged nerves.

[0079] Example 3

[0080] In one specific embodiment, firstly, under clean conditions, gelatin with a molecular weight of 80,000-100,000 is placed in hexafluoroisopropanol at 10°C to swell and dissolve, forming a 30wt% gelatin solution. Then, 0.1wt% sodium chloride, 0.1wt% Tween, and 0.1wt% sulfadiazine are added to prepare a sol solution. The solution is then subjected to ultrasonic vibration for 30 minutes to remove air bubbles. The sol solution is then added to a circulating storage tank A19, and the sol solution circulation pump 18 is started to achieve dynamic circulation between the inner and outer circulation tanks at 5°C. The water storage tank 22 is then filled with water, and the water circulation pump 21 is started to achieve dynamic circulation in the insulated container 16 at T=3°C. A 50μm diameter copper wire is led out from the template plate 10, passes through a nylon bearing, and provides a sensing signal to the template sensor 3. Afterward, the wire passes through the clamping sponge A5 and the corresponding coaxial positioning hole 32, using rapeseed oil as a release agent. The first pneumatic gripper 1 grips the copper wire extending from the coaxial positioning hole 32 via pneumatic drive, while the second pneumatic gripper 2 simultaneously grips it without moving. Both grippers 1 and 2 move linearly to the right of the auxiliary pneumatic gripper 13 via electric drive. The auxiliary pneumatic gripper 13 closes to grip the copper wire, and the first and second grippers 1 and 2 open. Then, the first and second grippers 1 and 2 rise along the guide rail of the horizontal support 6, move horizontally to the left, and then descend to a position where they can grip the copper wire. The first and second grippers 1 and 2 close pneumatically to grip the copper wire, and the cutting blade 11 cuts the copper wire on the left side of the first gripper 1, allowing the auxiliary pneumatic gripper 13 to open. Subsequently, the first pneumatic gripper 1 and the second pneumatic gripper 2 move upward, then to the right, and then downward along the horizontal support 6, until they are level with the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8, and within their gripping range. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 grip firmly under gas drive. The first pneumatic gripper 1 and the second pneumatic gripper 2 open and reset. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 grip the copper wire and move downward, adhesive, and upward synchronously. This entire process is cyclical, accompanied by continuous rotation and oscillation of the grippers and the copper wire. The parameters are: d = 5s, N = 1, M = 10rpm, X = 10°, Y = 10Hz, and Z = 40s.After the copper wire is evenly coated, the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 move up to the vicinity of the guide rail. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24 move horizontally to the inside of the first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8, and move down to a position where the gripping point can grasp the copper wire. The third transmission pneumatic gripper 23 and the fourth transmission pneumatic gripper 24 firmly grasp the copper wire coated with adhesive. The first adhesive pneumatic gripper 7 and the second adhesive pneumatic gripper 8 open and return to their original positions. Hand 23 and the fourth pneumatic gripper 24 move upwards synchronously, placing the stainless steel wire coated with adhesive into the porous stainless steel trough 25, and manually transferring it to a stainless steel trough 26 containing 5% formaldehyde crosslinking solution for crosslinking at a temperature of 15℃. After crosslinking, the sample is removed, demolded, and cut to obtain a medical hollow catheter with an outer diameter of 150±5μm, an inner diameter of 55±1.5μm, and a length of 8.00±0.25mm. This medical hollow catheter can be used for drainage of aqueous humor in the fundus.

[0081] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is impossible to exhaustively list all the implementation methods here. All obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A method for preparing a medical hollow catheter, characterized in that, Medical hollow catheters are prepared using a preparation apparatus comprising: Template preparation component for providing the inner core template for medical hollow catheters; A tube wall preparation assembly is used to coat the outer wall of an inner core template to prepare a pre-demolding conduit. The post-processing component is used to cross-link, demold, and cut the catheter before demolding to prepare a medical hollow catheter. And a horizontal support running between the template preparation assembly and the tube wall preparation assembly; The horizontal support includes a molding area and a wall forming area. The template preparation component, the pipe wall preparation component, and the post-processing component are arranged sequentially. The template preparation component is located in the molding area of ​​the horizontal support, and the pipe wall preparation component is located in the wall forming area of ​​the horizontal support. The template preparation component includes Template disk, used to provide template filaments; The first transfer gripping component is used to grip, pull, and transfer the template filament; Release agent coating assembly for coating the outer surface of template filaments with release agent; And a cutting component for cutting the pulled-out template filaments; The outlet end of the template disk is connected to the coaxial positioning hole of the mold release agent coating component, and the coaxial positioning hole is connected to one end of the horizontal support. The first transmission gripping component is located above the molding area of ​​the horizontal support, and the cutting component is located outside the molding area of ​​the horizontal support. The tube wall preparation assembly includes an adhesive gripping assembly, a sol circulation system, a circulating heat preservation system, and a sol convex surface generation assembly. The adhesive gripping component is configured to grip the inner core template for adhesive application; the solvent circulation system is configured to stably supply the solvent, the solvent circulation system including an outer circulation tank, an inner circulation tank, and a circulation storage tank; the circulation insulation system is configured to maintain the temperature of the solvent, the circulation insulation system including an insulation container and a water circulation insulation component, the insulation container being connected to the water circulation insulation component via piping; the solvent convex surface generating component is configured to form a convex surface of the solvent in the inner circulation tank; The post-processing assembly includes a porous stainless steel rack for holding the pre-demolding conduit; a stainless steel tank for holding a crosslinking liquid to achieve crosslinking treatment of the pre-demolding conduit; and a second transfer gripping assembly configured to transfer the pre-demolding conduit. The preparation method includes the following steps: The template filament is drawn out from the template plate, passes through the coaxial positioning hole of the release agent coating component, and is pulled out horizontally along the horizontal support molding area by the first transmission gripping component. At the same time as the template filament is pulled out, the release agent is applied at the coaxial positioning hole. After being cut by the cutting component, the inner core template is obtained. Then the first transfer gripping component grips the template filament to the horizontal support wall-making area, and the adhesive gripping component grips the template filament and lowers it, so that the outer surface of the template filament is immersed in the inner circulation tank containing the sol solution, and under the action of the adhesive gripping component, it undergoes multiple immersion, leaching, rotation and oscillation to prepare a pre-demolding conduit coated with sol solution. Then, the adhesive gripping component is controlled to grip the pre-demolding catheter and move it to the horizontal support wall-making area. The second transfer gripping component replaces the adhesive gripping component to grip the pre-demolding catheter onto the porous stainless steel tray. The porous stainless steel tray is then transferred to a stainless steel tank containing a crosslinking agent solution for crosslinking. After crosslinking, the catheter is demolded, cut, and finally a medical hollow catheter is obtained. The raw materials of the sol solution include biopolymers, additives, pharmaceutical components, and emulsifiers.

2. The preparation method according to claim 1, characterized in that, The amount of the biopolymer added is 1~100wt%, the amount of the additive added is 0~40wt%, the amount of the drug component added is 0~40wt%, and the amount of the emulsifier added is 0~20wt%. The preparation steps of the sol solution are as follows: adding biopolymers, additives, emulsifiers and drug components to the solvent in proportion, dissolving, defoaming and then placing it in a circulating storage tank for warming and later use.

3. The preparation method according to claim 2, characterized in that, The biopolymer is selected from one or more of type I collagen, gelatin, chitosan, chitosan oligosaccharide, sodium carboxymethyl cellulose, collagen, glycosaminoglycans, alginate, hydroxymethyl chitosan, polycaprolactone, or chitosan.

4. The preparation method according to claim 2, characterized in that, The additive is selected from one or more of sodium chloride, calcium chloride, glycerin, polyvinyl alcohol, polyethylene glycol, ethyl carbodiamine, or isohexamethylene dicyanate.

5. The preparation method according to claim 2, characterized in that, The emulsifier is selected from one or more of glyceryl monostearate, propylene glycol stearate, polyglycerol fatty acid ester, sorbitol, or Tween.

6. The preparation method according to claim 2, characterized in that, The drug components are selected from one or more of ethamsylate, mupirocin, gentamicin sulfate, dexamethasone sodium tinidazole, clindamycin hydrochloride, Panax notoginseng, indigo naturalis, pearl powder, or Yunnan Baiyao.

7. The preparation method according to claim 2, characterized in that, The dissolution temperature is 0~160℃.

8. The preparation method according to claim 2, characterized in that, The insulation temperature is 10~95℃.

9. The preparation method according to claim 2, characterized in that, The mass concentration of the sol solution is 0.1-60 wt%.

10. The preparation method according to claim 2, characterized in that, The solvent is selected from one or more of water, formic acid, acetic acid, hydrochloric acid, salicylic acid, aqueous ethanol solution, urea, thiourea, aqueous potassium bromide solution, aqueous sodium chloride solution, glycerol, dichloromethane, tetrahydrofuran, trifluoroethanol, or hexafluoroisopropanol.

11. The preparation method according to claim 1, characterized in that, The release agent is selected from one or more of the following: diesel oil, gasoline, engine oil, capsule oil, cottonseed oil, soybean oil, peanut oil, rapeseed oil, sunflower seed oil, corn germ oil, and olive oil. The crosslinking agent is selected from one or more of glutaraldehyde, carbodiimide, genipin, divinyl sulfone, formaldehyde, glyoxal, malondialdehyde, succinaldehyde, hexadialdehyde, heptadialdehyde, octanaldehyde, nonadialdehyde, sebacaldehyde, glucose, dialdehyde glucose, dextran, oxidized glucose, oxidized dextran, diepoxide, and divinyl sulfone.

12. The preparation method according to claim 1, characterized in that, The crosslinking temperature is 15-45℃.

13. The preparation method according to claim 1, characterized in that, The concentration of the crosslinking agent is 0.0001~60wt%.

14. The preparation method according to claim 1, characterized in that, The template filaments are selected from one of the following: steel wire, copper wire, iron wire, nickel wire, lead wire, gut wire, nylon wire, polyester wire, polyglycolic acid wire, polyethylene wire, polyester wire, polydioxane wire, polydioxane-1, and polyglycolic acid wire.

15. The preparation method according to claim 1, characterized in that, The diameter of the template filament is 30-5000 μm.

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