A high molecular developing ring, a preparation tool and method thereof and application

Abstract

The application relates to a high-molecular developing ring, a preparation tool and a preparation method thereof and application. The developing ring comprises a ring structure and a developing agent. The ring structure comprises an outer ring surface, an inner ring surface and a recess on an inner surface. The developing agent is contained in the ring structure and comprises one or more metal powders. The preparation tool of the developing ring comprises a main body, a pressure assembly and a fixing assembly, and can rapidly prepare the high-molecular developing ring. The preparation method comprises mixing a high-molecular polymer and the developing agent, preparing a film from the mixed material, fixing, exhausting and heating and shaping the film, taking out the developing ring after cooling and carrying out subsequent treatment. The high-molecular developing ring has good elasticity and flexibility, has strong connection performance with a catheter, is simple to prepare and can effectively improve diagnostic accuracy and treatment effect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a polymer radiopaque ring, its preparation tooling, preparation method, and application. Background Technology

[0002] Balloon catheters are widely used medical devices in cardiovascular, peripheral vascular, and non-vascular interventional treatments. The contrast ring, as an important component of the balloon catheter, is mainly used to provide clear images under X-rays, helping doctors to accurately locate and manipulate the catheter.

[0003] Traditional contrast rings are typically made of metal, such as platinum-iridium alloy contrast rings, which are widely used in interventional therapy due to their excellent properties such as corrosion resistance, oxidation resistance, and wear resistance. However, metal contrast rings have high rigidity. Chinese invention patent application number 202010998024.6 discloses a contrast ring and a balloon dilation catheter using the contrast ring, in which the contrast ring is made of 304 stainless steel or titanium steel. These metal contrast rings, due to their high elastic modulus, are not easily bent and lack necessary flexibility, which may lead to difficulty in movement through complex vascular pathways. Furthermore, the main fixation method for metal contrast rings is forging fixation, which may result in insufficient connection strength between the contrast ring and the catheter due to improper pressure control, thus causing the contrast ring to slip out. Summary of the Invention

[0004] The purpose of this invention is to provide a polymer radiopaque ring, its preparation tooling and preparation method, and its application, and to develop a radiopaque ring with good flexibility and good inter-catheter connection performance, so as to solve the problems existing in the prior art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] This invention provides a polymer developing ring and its preparation fixture, comprising a polymer developing ring and a preparation fixture; the polymer developing ring includes a ring-shaped body and a pit structure 122 on its inner surface, the ring-shaped body being made of a mixture of polymer material and developer; the outer surface of the ring-shaped body is cylindrical, and the inner cavity is frustoconical; the polymer developing ring preparation fixture includes a main body, a pressure assembly, and a fixing assembly; the pressure assembly is used to apply pressure to fully expel air from the polymer developing ring; the fixing assembly is used to fix and form the shape of the developing ring; the main body includes a first main body and a second main body symmetrically arranged; a left handle and a right handle are respectively provided on the outer sides of the first main body and the second main body; the pressure assembly is a scissor mechanism; the first main body is connected to the second main body through the scissor mechanism. The main body and fixing components include a left ejector pin, a right ejector pin, and a shaping mold. The left and right ejector pins are slender cylindrical tubes with an inner diameter of 1.5 mm to 8.5 mm and an outer diameter of 2 mm to 10 mm, used to fix the shaping mold. The shaping mold includes an outer mold and an inner mold. The outer mold is a metal tube of equal diameter, with an inner diameter 0.1 to 0.4 mm larger than the outer diameter of the target developing ring and a wall thickness of 0.8 mm to 1 mm. The inner mold consists of a flat cylindrical rod and 3 to 6 detachable thin plates with protrusions on their surfaces. These thin plates can be combined axially to form a cylindrical structure. The overall outer diameter of the cylindrical structure is 0.1 to 0.5 mm smaller than the inner diameter of the target developing ring at the corresponding position. The outer mold is 8 mm to 10 mm shorter than the inner mold as a whole, facilitating the separation of the inner and outer molds and the developing ring.

[0007] Furthermore, this invention also provides a method for preparing a polymeric developing ring, which uses the aforementioned preparation tooling to prepare the developing ring, and includes the following steps:

[0008] Step 1: Prepare polymer materials and developer in a mass ratio of 1:2 to 1:1. Under the condition of uniform stirring at 60℃-80℃ and 250±10r / min, first completely dissolve the polymer materials in the organic solvent, wait for at least 30 minutes, then add the developer and mix evenly.

[0009] Step 2: Use a coating device to uniformly coat the polymer material and developer mixture onto the substrate to form a thin film, and dry it at 90℃ to 100℃ for more than 12 hours;

[0010] Step 3: Roll the heated and dried film evenly onto the inner mold of the shaping mold, then put on the outer mold, leaving 4mm to 5mm of length at both ends of the inner mold. Then insert both ends of the inner mold into the left and right ejector pins respectively; apply pressure to the left and right handles of the preparation tool to remove air, and then place the film and the entire preparation tool into a heating device at 120℃ to 220℃ for 3min to 10min to shape it into a polymer developing ring;

[0011] Step 4: After the polymer developing ring cools, remove it from the preparation fixture. Then, remove the round rods from the outer mold and the inner mold in sequence. Under a microscope, separate the thin film of the inner mold from the inner wall of the developing ring. Finally, perform subsequent processing on the developing ring, including cutting off excess material and trimming the edges.

[0012] In the aforementioned polymer developing ring and its preparation tooling, the pits are arranged circumferentially along the inner surface of the frustum, and the shape of the pits is one of circular, elliptical, and square.

[0013] In the aforementioned polymeric developing ring and its preparation tooling, the polymeric material is one or a mixture of polyurethane, polyether block polyamide, and nylon.

[0014] In the aforementioned polymer developing ring and its preparation tooling, the developing agent is one or a mixture of tungsten powder, barium sulfate, bismuth oxychloride, and bismuth carbonate.

[0015] In the aforementioned polymer developing ring and its preparation tooling, the metal sheet protrusions included in the shaping mold of the preparation tooling are one of the following shapes: circular, elliptical, and square.

[0016] In the aforementioned polymer developing ring and its preparation tooling, the pressure assembly includes a first lever, a second lever, a third lever, and a fourth lever; the first lever 3, the second lever 4, the third lever 5, and the fourth lever 6 are respectively movably connected to the two ends of the first body and the second body; the first lever, the second lever, the third lever, and the fourth lever are movably connected in the middle with a support rod.

[0017] In the above-mentioned polymer developing ring and its preparation tooling, in the preparation method, in step three, the two ends of the inner mold are left with a length of 4mm to 5mm respectively. This can ensure that the two ends of the inner mold have a certain support in the left and right ejector pins, and the length should not be too long to ensure the ease of operation when inserting the ejector pins.

[0018] An application of a polymer radiopaque ring in a balloon catheter: the radiopaque ring prepared using the above-described tooling and method is connected to the inner catheter and the balloon body; the inner catheter passes through the radiopaque ring, and the radiopaque ring is fixedly connected between the inner catheter and the balloon body; the inner ring surface of the radiopaque ring is tightly bonded to the inner catheter of the balloon catheter with medical-grade adhesive, and the outer ring surface of the radiopaque ring is tightly bonded to the balloon body with medical-grade adhesive.

[0019] The beneficial effects of this invention are:

[0020] Compared to traditional metal contrast rings, the polymer contrast ring provided by this invention exhibits superior flexibility and elasticity, allowing it to better adapt to the complex morphology of blood vessels and improving its navigation performance within the vessel. It can be bonded to catheters using medical-grade adhesives, simplifying the manufacturing process and improving connection performance.

[0021] The developing ring preparation fixture provided by this invention is simple to operate, reusable, and saves resources and costs. It has a simple structure and is easy to disassemble. Different sizes of developing rings can be produced by using different specifications of ejector pins and different numbers of thin sheets. Attached Figure Description

[0022] The following figures are provided to more clearly illustrate specific embodiments of the present invention.

[0023] Figure 1 This is a schematic diagram of the structure of the polymer imaging ring 12 of the present invention.

[0024] Figure 2 and Figure 3 This is a schematic diagram of the tooling for preparing the developing ring according to the present invention.

[0025] Figure 4 This is a flowchart of the developing ring preparation method of the present invention.

[0026] Figure 5 This is a schematic diagram illustrating the application of the polymer imaging ring of the present invention in a medical device.

[0027] In the diagram, 1—first main body; 2—second main body; 3—first lever; 4—second lever; 5—third lever; 6—fourth lever; 7—left handle; 8—right handle; 9—left ejector pin; 10—right ejector pin; 11—forming mold; 12—developing ring; 121—ring-shaped main body; 122—recessed structure; 13—inner catheter; 14—balloon body. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the invention.

[0029] Example 1

[0030] refer to Figures 1 to 5 This invention provides a contrast-enhancing ring 12, comprising an annular body 121 and a recessed structure 122 on its inner surface; the outer surface of the annular body is cylindrical, and the inner cavity is frustum-shaped, with the inner cavity diameters differing by 0.5-1 mm. The regularly spaced recessed structures 122 on the inner surface of the polymer contrast-enhancing ring are arranged circumferentially along the inner surface, and their shapes are circular, elliptical, square, or other regular polygons, with a recess depth of 0.2-0.5 mm. The inner annular surface of the polymer contrast-enhancing ring of this invention is designed as a frustum-shaped cone. The regularly spaced recessed structures 122 on the inner surface increase the contact area with the adhesive when connecting the catheter with medical-grade adhesive, thereby effectively improving the connection performance between the contrast-enhancing ring and the catheter.

[0031] The outer diameter of the annular structure is 2 mm to 10 mm, the inner diameter is 1 mm to 8 mm, and the wall thickness of the annular structure is 0.5 mm to 4.5 mm. The polymer imaging ring of this invention can flexibly adjust the processing technology according to different medical application scenarios and needs, including adjusting the ratio of polymer material to contrast agent, to achieve the required imaging effect and physical properties. Furthermore, the preparation tooling of this invention can be customized to produce imaging rings of different sizes by changing different specifications of ejector pins and shaping molds to adapt to various medical needs, thereby improving production flexibility and efficiency.

[0032] The polymeric imaging ring has a breaking strength greater than or equal to 40 N and an elastic modulus less than or equal to 42 GPa. Compared with metal imaging rings, the polymeric imaging ring of this invention has a lower elastic modulus, exhibiting good flexibility and elasticity. This characteristic allows the imaging ring to better adapt to the complex shape of blood vessels, improving its navigation performance within the vessel. The recesses are arranged circumferentially along the inner surface of the frustum-shaped ring, and are circular, elliptical, square, or other regular polygonal in shape. This increases the contact area between the inner lumen of the imaging ring and the adhesive when using adhesive to connect the imaging ring to the catheter, thereby enhancing the connection performance.

[0033] The ring-shaped main body of the developing ring is made of a mixture of polymer materials and developer. The polymer materials are thermoplastic elastomers, such as polyurethane, polyether block polyamide, nylon, etc.

[0034] The developing agent can be made of materials with developing effects, such as tungsten powder, barium sulfate, bismuth oxychloride, and bismuth carbonate. Nano-sized tungsten powder can also be used as the developing agent, as it has a high density and good absorption effect on X-rays, thus enhancing the developing effect.

[0035] In addition, a preparation fixture is provided, which allows for more convenient and rapid preparation of polymeric developing rings, exhibiting good practicality and economy. For example... Figure 2The invention illustrates a developing ring preparation fixture, entirely made of a metal material resistant to temperatures up to 300°C, used for fixing and shaping a polymer developing ring. The fixture includes a main body, a pressure assembly, and a fixing assembly. The pressure assembly applies pressure to fully expel air from the polymer developing ring. The fixing assembly fixes and shapes the developing ring. The material of the fixing assembly in contact with the developing ring is corrosion-resistant, reducing contamination of the developing ring. The main body includes a symmetrically arranged first main body 1 and a second main body 2, with a left handle 7 and a right handle 8 on the outer sides of the first and second main bodies 1 and 2, respectively. The pressure assembly is a scissor mechanism. The first main body 1 is connected to the second main body 2 via the scissor mechanism. The pressure assembly includes a first lever 3, a second lever 4, a third lever 5, and a fourth lever 6. The ends of the first lever 3, second lever 4, third lever 5, and fourth lever 6 are movably connected to the ends of the first main body 1 and the second main body 2, respectively. A support rod is movably connected through the middle of the first lever 3, second lever 4, third lever 5, and fourth lever 6. The fixing assembly includes a left ejector pin 9, a right ejector pin 10, and a shaping mold 11. Ejector pin 9 and right ejector pin 10 are slender cylindrical tubes with an inner diameter of 1.5mm to 8.5mm and an outer diameter of 2mm to 10mm, used to fix the shaping mold 11. The shaping mold includes an outer mold and an inner mold. The outer mold is a metal tube of equal diameter, with an inner diameter 0.1mm to 0.4mm larger than the outer diameter of the target developing ring and a wall thickness of 0.8mm to 1mm. The inner mold consists of a flat cylindrical rod and 3 to 6 detachable thin sheets with protrusions on their surfaces. These sheets can be combined axially to form a cylindrical structure. The overall outer diameter of the cylindrical structure is 0.1mm to 0.5mm smaller than the corresponding inner diameter of the target developing ring. The outer mold is 8mm to 10mm shorter than the inner mold to facilitate the separation of the inner and outer molds and the developing ring. (Reply: The protruding thin sheets form a cylindrical structure, and then a flat cylindrical rod is placed inside the cylindrical tube to form a cylindrical structure. The detachable structure is used to facilitate the removal of the developing ring after the shaping process is completed.)

[0036] like Figure 3 The inner mold of the shaping mold 11 of the fixed component shown consists of a flat round rod and 3 to 6 detachable metal sheets with circular, square, or elliptical protrusions on their outer surfaces, used to create regular pits on the inner wall of the developing ring after molding. The sheets can be combined axially to form a cylindrical structure.

[0037] like Figure 4 The following is a detailed implementation process of the developing ring preparation method of the present invention, with the following steps:

[0038] Step 1: Weigh 4±0.02g of polyurethane and 7±0.02g of nano-sized tungsten powder separately using a balance. First, add 200±5ml of organic solvent to completely dissolve the polyurethane. After dissolving for 30 minutes, slowly pour the tungsten powder into the dissolved solution. This process must be carried out at 60℃ and a stirring speed of 250±10r / min until a particle-free, homogeneous mixture is formed. Strict control of the mass ratio and the order in which the materials are dissolved is crucial throughout this process. High-speed stirring must be used throughout, and the stirring and dissolving process must be carried out at a specific temperature with precise control of the stirring speed to ensure the homogeneity of the mixture.

[0039] Step 2: Using a 50mL syringe, accurately measure 30±1mL of the prepared solution and inject it into a glass dish measuring 100mm long, 100mm wide, and 30mm deep. This process allows for precise control of the cured film thickness, and the coating thickness must be monitored in real time during the coating process. Pre-drying is then performed to optimize the solvent evaporation rate and film formation. The glass dish is placed in a preheated oven at 90℃ for up to 12 hours to allow the solution to gradually form a film and solidify. The coated film needs to be pre-dried in a specific temperature environment to remove some of the solvent and prevent deformation during subsequent processing. Heating devices can include a hot oven or a constant temperature water bath.

[0040] Step 3: Remove the heated and dried film from the oven and roll it evenly along the axial direction onto the inner mold of the shaping mold 11. Then, put on the outer mold, leaving 4mm to 5mm of space at both ends of the inner mold. Insert both ends of the inner mold into the left ejector pin 9 and the right ejector pin 10, respectively. The left ejector pin 9 and the right ejector pin 10 are long and thin cylindrical tubes used to fix the shaping mold 11 and press the film to expel air. The operator needs to hold the left handle 7 and the right handle 8 of the preparation fixture with one hand and apply pressure to press the film and expel as much excess air as possible. Then, place the developing ring preparation fixture into the heating device. In this embodiment, the heating device is a hot oven set to 200℃. Place the entire fixture into the hot oven and heat for 3 minutes to heat and shape the developing ring, promoting the curing of the mixed material. The heating device needs to have precise temperature control and uniform heat distribution. The heating time needs to be precisely controlled to achieve uniform film forming.

[0041] Step 4: After heating is complete, remove the fixture. Once completely cooled, remove the shaped polymer developing ring from the left ejector pin 9 and right ejector pin 10. Then, remove the round rods from the outer and inner molds in sequence. At this point, the thin sheet of the fixing component is attached to the inner wall of the developing ring. This sheet needs to be separated under a microscope to obtain the formed developing ring 12. Next, precisely cut the polymer developing ring to remove excess material, with a length of 4.5 mm. Trim the edges to ensure the surface quality of the developing ring, resulting in a polymer developing ring 12 with an inner diameter of 2.5 mm, an outer diameter of 3.5 mm, and a wall thickness of 0.5 mm. Figure 1 As shown.

[0042] Through the above embodiments, a polymeric radiopaque ring with a certain degree of flexibility can be prepared. In this embodiment, thermoplastic polyurethane elastomer is selected as the polymeric material. After being prepared into a polymeric radiopaque ring, it has a certain degree of elasticity and flexibility, and can adapt to blood vessels of different shapes. The breaking strength of the radiopaque ring is greater than or equal to 40N, and the elastic modulus is less than or equal to 42GPa, as shown in Table 1 below.

[0043] Table 1 Mechanical properties of the developing ring of the present invention

[0044]

[0045] like Figure 5 The illustration shows the application of the polymeric contrast-enhancing ring 12 of the present invention in a balloon catheter, specifically in an aortic counterpulsation balloon for the treatment of heart failure. In this embodiment, the polymeric contrast-enhancing ring 12 is fixed at the distal end of the balloon, located between the inner catheter 13 and the balloon body 14, and includes an inner ring surface and an outer ring surface. The inner ring surface of the contrast-enhancing ring 12 is tightly bonded to the inner catheter 13 of the balloon catheter using medical-grade adhesive, and the outer ring surface of the contrast-enhancing ring 12 is tightly bonded to the balloon 14 using medical-grade adhesive. Due to the specific shape of the contrast-enhancing ring and the pits on its inner surface, the contact area of ​​the adhesive is increased, thereby enhancing the connection performance between the contrast-enhancing ring and the catheter and preventing the contrast-enhancing ring from slipping off the catheter. Simultaneously, the polymeric contrast-enhancing ring of the present invention contains a contrast agent; in this embodiment, nano-sized tungsten powder is used, which has a high density and good X-ray absorption effect, effectively enhancing the contrast-enhancing effect. Furthermore, the ratio of tungsten powder to polyurethane can be adjusted according to the application scenario to meet different application requirements in terms of contrast-enhancing effect and elasticity.

[0046] After the balloon catheter is inserted into the patient's blood vessel, X-ray imaging is used for visualization. A polymer imaging ring helps the doctor confirm the balloon catheter's position. Based on the imaging results, the balloon's position can be adjusted until the desired location is achieved.

[0047] Example 2

[0048] like Figure 4The following is a detailed implementation process of the developing ring preparation method of the present invention, with the following steps:

[0049] Step 1: Weigh 4±0.02g of polyether block polyamide and 8±0.02g of barium sulfate separately using a balance. First, add 200±5ml of organic solvent to completely dissolve the polyether block polyamide. After dissolving for 30 minutes, slowly pour the barium sulfate into the dissolved solution. This process must be carried out at 80℃ and a stirring speed of 250±10r / min until a particle-free, homogeneous mixture is formed. Strict control of the mass ratio and the order in which the materials are dissolved is crucial throughout this process. High-speed stirring must be used throughout the entire process, and the stirring and dissolution process must be carried out at a specific temperature with precise control of the stirring speed to ensure the homogeneity of the mixture.

[0050] Step 2: Using a 50mL syringe, accurately measure 30±1mL of the prepared solution and inject it into a glass dish measuring 100mm long, 100mm wide, and 30mm deep. This process allows for precise control of the thickness of the cured film, and the coating thickness needs to be monitored in real time during the coating process. Pre-drying is then performed to optimize the solvent evaporation rate and film formation. The glass dish is placed in a preheated oven at 100℃ for up to 12 hours to allow the solution to gradually form a film and solidify. The coated film needs to be pre-dried in a specific temperature environment to remove some of the solvent and prevent deformation during subsequent processing. Heating devices can include a hot oven or a constant temperature water bath.

[0051] Step 3: Remove the heated and dried film from the oven and roll it evenly along the axial direction onto the inner mold of the shaping mold 11. Then, put on the outer mold, leaving 4mm to 5mm of length at each end of the inner mold. Insert the two ends of the inner mold into the left ejector pin 9 and the right ejector pin 10, respectively. The operator should hold the left handle 7 and the right handle 8 of the preparation fixture with one hand and apply pressure to compress the film and expel as much excess air as possible. Then, place the developing ring preparation fixture into the heating device. In this embodiment, a hot oven is used as the heating device, and the temperature is set to 220℃. Place the entire fixture into the hot oven and heat for 5 minutes to perform the heating and shaping process of the developing ring, so as to promote the curing of the mixed material. The heating device must have precise temperature control and uniform heat distribution. The heating time must be precisely controlled during the heating process to achieve uniform film forming.

[0052] Step 4: After heating is complete, remove the fixture. Once completely cooled, remove the shaped polymer developing ring from the left ejector pin 9 and right ejector pin 10. Then, remove the round rods from the outer and inner molds in sequence. At this point, the thin sheet of the fixing component is attached to the inner wall of the developing ring. This sheet needs to be separated under a microscope to obtain the formed developing ring 12. Next, precisely cut the polymer developing ring to remove excess material, with a length of 4.5 mm. Trim the edges to ensure the surface quality of the developing ring, resulting in a polymer developing ring 12 with an inner diameter of 2.5 mm, an outer diameter of 3.5 mm, and a wall thickness of 0.5 mm. Figure 1 As shown.

[0053] Example 3

[0054] like Figure 4 The following is a detailed implementation process of the developing ring preparation method of the present invention, with the following steps:

[0055] Step 1: Weigh 4±0.02g of nylon and 4±0.02g of bismuth carbonate separately using a balance. First, add 200±5ml of organic solvent to completely dissolve the nylon. After dissolving for 30 minutes, slowly pour the bismuth carbonate into the dissolved solution. This process must be carried out at 70℃ and a stirring speed of 250±10r / min until a particle-free, homogeneous mixture is formed. Strict control of the mass ratio and the order in which the materials are dissolved is crucial throughout this process. High-speed stirring must be used throughout, and the stirring and dissolving process must be carried out at a specific temperature with precise control of the stirring speed to ensure the homogeneity of the mixture.

[0056] Step 2: Using a 50mL syringe, accurately measure 30±1mL of the prepared solution and inject it into a glass dish measuring 100mm long, 100mm wide, and 30mm deep. This process allows for precise control of the thickness of the cured film, and the coating thickness needs to be monitored in real time during the coating process. Pre-drying is then performed to optimize the solvent evaporation rate and film formation. The glass dish is placed in a preheated oven at 95℃ for up to 12 hours to allow the solution to gradually form a film and solidify. The coated film needs to be pre-dried in a specific temperature environment to remove some of the solvent and prevent deformation during subsequent processing. Heating devices can include a hot oven or a constant temperature water bath.

[0057] Step 3: Remove the heated and dried film from the oven and roll it evenly along the axial direction onto the inner mold of the shaping mold 11. Then, put on the outer mold, leaving 4mm to 5mm of length at each end of the inner mold. Insert the two ends of the inner mold into the left ejector pin 9 and the right ejector pin 10, respectively. The operator should hold the left handle 7 and the right handle 8 of the preparation fixture with one hand and apply pressure to compress the film and expel as much excess air as possible. Then, place the developing ring preparation fixture into the heating device. In this embodiment, a hot oven is used as the heating device, and the temperature is set to 120℃. Place the entire fixture into the hot oven and heat for 10 minutes to perform the heating and shaping process of the developing ring, so as to promote the curing of the mixed material. The heating device must have precise temperature control and uniform heat distribution. The heating time must be precisely controlled during the heating process to achieve uniform film forming.

[0058] Step 4: After heating is complete, remove the fixture. Once completely cooled, remove the shaped polymer developing ring from the left ejector pin 9 and right ejector pin 10. Then, remove the round rods from the outer and inner molds in sequence. At this point, the thin sheet of the fixing component is attached to the inner wall of the developing ring. This sheet needs to be separated under a microscope to obtain the formed developing ring 12. Next, precisely cut the polymer developing ring to remove excess material, with a length of 4.5 mm. Trim the edges to ensure the surface quality of the developing ring, resulting in a polymer developing ring 12 with an inner diameter of 2.5 mm, an outer diameter of 3.5 mm, and a wall thickness of 0.5 mm. Figure 1 As shown.

[0059] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A high molecular developing ring and a preparation tool thereof, characterized in that, The application relates to a high-molecular developing ring (12) and a preparation tool, wherein the high-molecular developing ring (12) comprises a ring body (121) and a concave structure (122) on the inner surface of the ring body (121), the ring body (121) is made of a mixture of a high-molecular material and a developer, the outer surface of the ring body (121) is cylindrical, and the inner cavity of the ring body (121) is frustoconical; the preparation tool of the high-molecular developing ring comprises a main body, a pressure assembly and a fixing assembly; the pressure assembly is used for applying pressure to sufficiently discharge air in the high-molecular developing ring; the fixing assembly is used for fixing and forming the shape of the developing ring; the main body comprises a first main body (1) and a second main body (2) which are symmetrically arranged; left and right handles (7) and (8) are respectively arranged on the outer sides of the first main body (1) and the second main body (2); the pressure assembly is a scissor mechanism; the first main body (1) is connected to the second main body (2) through the scissor mechanism; the fixing assembly comprises left and right thimbles (9) and (10) and a shaping die (11); the left and right thimbles (9) and (10) are long and thin and in the shape of a pipe, the inner diameter is 1.5-8.5 mm, the outer diameter is 2-10 mm, and the left and right thimbles (9) and (10) are used for fixing the shaping die (11); the shaping die (11) comprises an outer die and an inner die; the outer die is a metal pipe with an equal diameter, the inner diameter of the outer die is 0.1-0.4 mm larger than the outer diameter of the target developing ring, and the wall thickness is 0.8-1 mm; the inner die is composed of a flat round bar and 3-6 detachable sheets with protrusions on the surfaces, the sheets can be combined into a pipe structure along the axial direction, the overall outer diameter of the pipe structure is 0.1-0.5 mm smaller than the inner diameter of the corresponding position of the target developing ring, and the outer die is 8-10 mm shorter than the inner die, so that the inner and outer dies and the developing ring can be separated.

2. The high polymer developing ring according to claim 1, wherein, The concaves are arranged along the circumferential direction of the inner surface of the frustoconical shape, and the concaves are in one of the shapes of a circle, an ellipse and a square.

3. The high polymer developing ring and its preparation tooling according to claim 1, characterized in that, The high-molecular material is one or a mixture of more than one of polyurethane, polyether block polyamide and nylon.

4. The high polymer developing ring and its preparation tooling according to claim 1, characterized in that, The developer is one or a mixture of more than one of tungsten powder, barium sulfate, bismuth oxychloride and bismuth carbonate.

5. The high polymer developing ring according to claim 1, wherein, The protrusions of the metal sheets of the shaping die (11) of the preparation tool are in one of the shapes of a circle, an ellipse and a square.

6. The high polymer developing ring according to claim 1, wherein, The pressure assembly comprises first, second, third and fourth levers (3, 4, 5 and 6); the two ends of the first, second, third and fourth levers (3, 4, 5 and 6) are movably connected to the two ends of the first and second main bodies (1 and 2) respectively; and the middle portions of the first, second, third and fourth levers (3, 4, 5 and 6) are movably connected with a support rod.

7. A method of producing a high molecular developer ring, characterized by, The developing ring prepared by the preparation tool of any one of claims 1 to 6 comprises the following steps: Step one: high-molecular material and developer are prepared according to the mass ratio of 1:2 to 1:1, the high-molecular material is completely dissolved in an organic solvent under the condition of uniform stirring at 60-80 DEG C and a rotating speed of 250+ / -10 r / min, and the developer is added after at least 30 min and is uniformly mixed. Step two: evenly coat the high polymer material and developer mixed solution on the substrate to form a film using a coating device, and dry at 90-100°C for 12 hours or more; Step three: evenly roll the dried film onto the inner mold of the shaping mold (11), then cover the outer mold, leave 4-5mm at both ends of the inner mold, then insert both ends of the inner mold into the left and right thimbles (9) and (10) respectively; apply pressure to the left and right handles (7) and (8) of the preparation tool to exhaust air, then put the film and the preparation tool into a 120-220°C heating device for 3-10 minutes to shape the high polymer developing ring; Step four: after the high polymer developing ring is cooled, remove it from the preparation tool, then remove the round rods in the outer mold and the inner mold in turn, then separate the sheet of the inner mold from the inner wall of the developing ring under a microscope, and finally perform subsequent processing on the developing ring, which includes cutting off excess material and trimming the edges.

8. A balloon catheter characterized by, The developing ring according to any one of claims 1-6, prepared by the preparation tool according to any one of claims 1-6 and the method according to claim 7; comprising an inner catheter (13) and a balloon body (14); the inner catheter (13) is arranged through the developing ring, and the developing ring is sleeved between the inner catheter (13) and the balloon body (14) and fixedly connected; the inner surface of the developing ring (12) is tightly attached to the inner catheter (13) of the balloon catheter through medical-grade glue, and the outer surface of the developing ring (12) is tightly attached to the balloon body (14) through medical-grade glue.

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