CN-121971714-A - Super-lubrication vascular puncture sheath tube and preparation method thereof

Abstract

The invention discloses a super-lubrication vascular puncture sheath tube and a preparation method thereof, belonging to the technical field of medical appliances. The material pipe is prepared from fluoroplastic, a slipping agent, an antioxidant and a developer according to a specific weight portion. The core of the invention is that the material body is modified to replace the traditional surface coating technology, the thermodynamic incompatibility of the slipping agent and the fluoroplastic is utilized, and the slipping agent spontaneously migrates to the inner and outer surfaces of the pipe in the thermal process of extrusion molding to form a stable and uniform nano/micron-sized lubricating film, thereby endowing the pipe with an ultralow dynamic friction coefficient. The preparation method comprises two working procedures of preparation of prefabricated materials and extrusion of pipes, wherein a unique gradient cooling shaping process is adopted after the extrusion of the pipes, and the migration behavior of the slipping agent is accurately regulated and controlled so as to optimize the formation of a lubricating film. The invention fundamentally solves the problems of easy abrasion of the lubricating layer, difficult uniform coverage of the inner wall, biological safety risk and complex process of the traditional coating sheath tube, and the prepared material tube has the comprehensive advantages of durable lubrication, high biological safety, reliable mechanical property, clear development and low production cost.

Inventors

• DAI HUAYING
• FAN GUOQIANG
• FENG YAO

Assignees

• 天津佳澳医疗器械有限公司

Dates

Publication Date

20260505

Application Date

20260226

Claims (10)

1. 1. A super-lubrication vascular puncture sheath tube is characterized by being prepared from the following raw materials, by weight, 0.5-10 parts of a slipping agent, 0.5-2 parts of an antioxidant, 5-10 parts of a developer and the balance of fluoroplastic, wherein the total amount of the components is 100 parts.
2. 2. The super-lubricative vascular puncture sheath tube of claim 1, wherein the slipping agent is 0.5-2 parts, the antioxidant is 1-2 parts, and the developer is 6-10 parts.
3. 3. The superlubricated vascular puncture sheath tubing according to claim 1 or 2, wherein the fluoroplastic is any one or a blend or copolymer of at least two of medical grade or food grade perfluoroethylene propylene copolymer (FEP), ethylene-tetrafluoroethylene copolymer (ETFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE).
4. 4. The super-lubricious vascular puncture sheath tubing of claim 1 or 2, wherein the slip agent is any one or a mixture of at least two of erucamide, polyolefin amide, oleic acid amide, stearic acid amide.
5. 5. The super-lubricative vessel puncture sheath tube according to claim 1 or 2, wherein the slipping agent is erucamide, polyolefin amide, oleamide, stearic acid amide with a purity of 99.5% or more.
6. 6. The super-lubricated vascular puncture sheath tube according to claim 1 or 2, wherein the antioxidant is formed by mixing an antioxidant 1010 and an antioxidant 168 according to a mass ratio of 1.5:1.0, and the developer is any one of barium sulfate, bismuth oxide and tungsten powder.
7. 7. The preparation method of the super-lubrication vascular puncture sheath tube is characterized by comprising the following steps of: S1, preparing a prefabricated material, namely weighing the raw materials according to the formula proportion, uniformly mixing, putting into a double-screw extruder, carrying out premix extrusion at 270-300 ℃ and granulating to obtain the prefabricated material; And S2, extruding the pipe, namely putting the prefabricated material into a single screw extruder, melting, plasticizing and extruding at 270-300 ℃, then entering a gradient cooling shaping device, reducing the surface temperature of the pipe from a molten state to below 80 ℃ within 30-120 seconds, and obtaining the super-lubrication vascular puncture sheath pipe through drafting, traction and cutting.
8. 8. The method according to claim 7, wherein in step S1, the uniform mixing is achieved by a high-speed mixer.
9. 9. The method according to claim 7 or 8, wherein in step S2, the gradient cooling and shaping device adopts a sectional temperature control method, the first section is air-cooled or water mist-cooled, the temperature is set to 150-200 ℃, the cooling time is 10-30 seconds, and the second section is water-cooled, and the temperature is set to 20-40 ℃.
10. 10. A vascular puncture sheath, characterized in that it is formed by the superlubricated vascular puncture sheath according to any of claims 1-6 by the method according to any of claims 7-9.

Description

Super-lubrication vascular puncture sheath tube and preparation method thereof Technical Field The invention belongs to the technical field of medical appliances, and particularly relates to a super-lubrication vascular puncture sheath tube and a preparation method thereof. Background The vascular puncture sheath is used as a basic stone instrument for modern minimally invasive interventional operation, and has the core function of establishing a stable channel from skin to a vascular cavity and providing a path for various instruments such as a guide wire, a catheter, a stent and the like to enter, so that vascular injury caused by repeated puncture is avoided. The current state of the art in this field presents a situation where "wide application" and "technical bottlenecks" coexist. In the application level, the sheath tube has evolved into a plurality of types such as a short sheath, a long sheath, a mountain-turning sheath, a balloon blocking sheath and the like according to clinical requirements so as to adapt to different anatomical parts and operation complexity requirements, and the diameter of the sheath tube is usually measured in Fr units, and the common range is between 4Fr and 14 Fr. The sheath system is usually operated by the sheath body and the expander in a cooperative way, and the proximal end is integrated with the leakage-proof valve and the side tube, so that the multifunctional integration of hemostasis, medicine injection, radiography and the like is realized, and the sheath system becomes an indispensable platform in interventional operations. However, the core bottleneck of the technology is focused on the treatment of surface smoothness. Currently the industry generally relies on surface coating techniques (such as hydrophilic polymer coatings or silicon-based lubricating layers) to enhance smoothness. The technical path has inherent defects of firstly insufficient durability, easy destruction or stripping of a coating under the conditions of repeated passage of instruments, tissue friction and body fluid, failure of a lubrication effect in a key operation stage, secondly uneven treatment, difficulty in forming a uniform and complete coating in a lumen of a long sheath with extremely large length-diameter ratio by the traditional coating technology, high friction coefficient of partial area of the inner surface, biocompatibility risk, possibility of falling-off of a coating material into a vascular system to cause embolism or immune reaction, possibility of generating foreign matter fragments due to unstable combination of the coating and a matrix material, and finally process complexity and cost problems, and high-quality coating treatment requires precise equipment and strict process control, thereby increasing production cost and affecting consistency among batches of products. Thus, although vascular puncture sheaths have become a mature product, the reliability, safety and durability of their surface lubrication technology is still a critical short plate that limits the effectiveness of surgery and patient experience. There is a need for a vascular puncture sheath tube technology that can fundamentally promote lubrication durability, biocompatibility and processing stability, so as to overcome the limitations of the existing surface coating scheme, such as easy abrasion, difficult covering of the inner wall, existence of biosafety risks, and the like, and meet the clinical demands for minimally invasive interventional instruments with high reliability and long-period safety. Disclosure of Invention The present invention aims to solve at least one of the technical problems in the related art to some extent. The super-lubrication characteristic is realized by material modification instead of surface coating, and the core of the super-lubrication characteristic is that fluoroplastic with a specific proportion is used as a base material, and the migration effect of a slipping agent is matched, so that the inner surface and the outer surface of the pipe spontaneously form a lubrication layer in the extrusion molding process, and the friction coefficient is obviously reduced. Meanwhile, the stability of the material in multiple high-temperature processing is ensured by adding the antioxidant, and the accurate positioning in the operation is realized by filling the developer. The integrated material design scheme aims at directly coping with common challenges of easy loss of a coating, insufficient mechanical stability, difficulty in uniformly covering a complex inner cavity, potential biocompatibility risks and the like existing in the prior coating technology. Simultaneously, a preparation method of the super-lubrication vascular puncture sheath tube and a vascular puncture sheath tube formed by processing and shaping the super-lubrication vascular puncture sheath tube are provided. The invention aims to provide a super-lubrication vascular puncture sheath tube which is characteri