Polymer developing ring and preparation tool, preparation method and application thereof

Abstract

The invention relates to a polymer developing ring and a preparation tool, a preparation method and application thereof, the developing ring comprises an annular structure and a developing agent, the annular structure comprises an outer ring surface, an inner ring surface and pits in the inner surface, the developing agent is contained in the annular structure, and the developing agent contains one or more metal powders; the developing ring preparation tool comprises a main body, a pressure assembly and a fixing assembly, and can be used for rapidly preparing a macromolecular developing ring; the preparation method comprises the following steps: mixing a high-molecular polymer and a developing agent, preparing a film from the mixed material, fixing, exhausting, heating and shaping the film, taking out the developing ring after cooling, and carrying out subsequent treatment. The polymer developing ring has good elasticity and flexibility, is high in connection performance with a catheter, is simple to prepare, and can effectively improve the diagnosis accuracy and the treatment effect.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a polymer developing ring and a preparation tool and method thereof and application thereof. Background Art

[0002] In cardiovascular, peripheral vascular and non-vascular interventional treatments, balloon catheters are a widely used medical device. As an important component of balloon catheters, the developing ring is mainly used to provide clear images under X-rays to help doctors accurately position and operate the catheter.

[0003] Traditional developing rings are usually made of metal materials, such as platinum-iridium alloy developing rings, which are widely used in interventional treatments due to their excellent properties such as corrosion resistance, oxidation resistance, and wear resistance. However, metal developing rings have high rigidity. The Chinese invention patent with patent application number 202010998024.6 discloses a developing ring and a balloon dilatation catheter using the developing ring, wherein the developing ring is made of 304 stainless steel and titanium steel. These metal developing rings have a large elastic modulus, are not easy to bend, and lack the necessary flexibility when in use, which may cause difficulty in moving in complex vascular pathways. In addition, the main fixing methods of metal developing rings are forging and fixing, which may cause the connection strength between the developing ring and the catheter to be insufficient due to improper pressure control, thereby causing the developing ring to slip. Summary of the invention

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

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] The present invention provides a polymer developing ring and a preparation tool thereof, including a polymer developing ring and a preparation tool; the polymer developing ring includes an annular main body and a pit structure 122 on its inner surface, the annular main body is made of a mixture of a polymer material and a developer; the outer surface of the annular main body is cylindrical, and the inner cavity is truncated cone; the polymer developing ring preparation tool includes a main body, a pressure component and a fixing component; the pressure component is used to apply pressure to fully discharge the air in the polymer developing ring; the fixing component 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 that are symmetrically arranged; a left handle and a right handle are respectively arranged on the outer sides of the first main body and the second main body; the pressure group is a scissor-type mechanism; the first main body is connected to the second main body through the scissor-type mechanism The main body; the fixed component includes a left ejector pin, a right ejector pin and a shaping mold; the left ejector pin and the right ejector pin are slender circular tubes with an inner diameter of 1.5mm to 8.5mm and an outer diameter of 2mm to 10mm, and are used to fix the shaping mold; the shaping mold includes an outer mold and an inner mold; the outer mold is an equal-diameter metal tube, whose inner diameter is 0.1 to 0.4mm larger than the outer diameter of the target developing ring, and the wall thickness is 0.8mm to 1mm; the inner mold is composed of a flat round rod and 3 to 6 detachable thin sheets with protrusions on the surface, wherein the thin sheets can be combined into a circular tube structure along the axial direction, and the overall outer diameter of the circular tube structure is 0.1 to 0.5mm smaller than the inner diameter of the corresponding position of the target developing ring; the outer mold is 8mm to 10mm shorter than the inner mold as a whole, so as to facilitate the separation of the inner and outer molds and the developing ring.

[0007] In addition, the present invention also provides a method for preparing a polymer developer ring, which uses the above-mentioned preparation tool to prepare the developer ring, comprising the following steps:

[0008] Step 1: Prepare polymer material and developer in a mass ratio of 1:2 to 1:1, and completely dissolve the polymer material in an organic solvent at 60°C-80°C and a constant speed of 250±10r / min, wait for at least 30 minutes, then add the developer and mix evenly;

[0009] Step 2: using a coating device to evenly coat the mixed solution of the polymer material and the developer on the substrate to form a thin film, and drying it at 90° C. to 100° C. for more than 12 hours;

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

[0011] Step 4: After the polymer developing ring is cooled, it is removed from the preparation tooling, and the round rods in the outer mold and the inner mold are removed in turn. Then, the thin sheet of the inner mold is separated from the inner wall of the developing ring under a microscope. Finally, the developing ring is subjected to subsequent processing, including cutting to remove excess material and trimming the edges.

[0012] In the above-mentioned polymer developing ring and the tooling for preparing the same, the pits are arranged circumferentially along the truncated cone-shaped inner surface, and the shape of the pits is one of circular, elliptical and square.

[0013] In the above-mentioned polymer developing ring and its preparation tooling, the polymer material is a mixture of one or more of polyurethane, polyether block polyamide and nylon.

[0014] In the above-mentioned polymer developing ring and its preparation tooling, the developer is a mixture of one or more of tungsten powder, barium sulfate, bismuth oxychloride, and bismuth carbonate.

[0015] In the above-mentioned polymer developing ring and its preparation tool, the shape of the metal sheet protrusions contained in the shaping mold of the preparation tool is one of circular, elliptical and square.

[0016] In the above-mentioned polymer developing ring and its preparation tooling, the pressure component includes a first lever, a second lever, a third lever and a fourth lever; the two ends of the first lever 3, the second lever 4, the third lever 5 and the fourth lever 6 are movably connected to the two ends of the first body and the second body respectively; the middle part of the first lever, the second lever, the third lever and the fourth lever is movable, and a support rod is connected through it.

[0017] In the above-mentioned polymer developer ring and its preparation tooling, in the preparation method, in step three, a length of 4mm to 5mm is left at both ends of the inner mold, which 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 pin.

[0018] A polymer developing ring is used in a balloon catheter. The developing ring prepared by the above-mentioned preparation tooling and preparation method is connected to an inner catheter and a balloon body; the inner catheter passes through the developing ring, and the developing ring is fixedly connected between the inner catheter and the balloon body; the inner ring surface of the developing ring is tightly fitted to the inner catheter of the balloon catheter by medical-grade glue, and the outer ring surface of the developing ring is tightly fitted to the balloon body by medical-grade glue.

[0019] The beneficial effects of the present invention are:

[0020] Compared with the traditional metal developing ring, the polymer developing ring provided by the present invention exhibits superior flexibility and elasticity, which enables it to better adapt to the complex morphology of blood vessels and improves the navigation performance of the developing ring in blood vessels. It can be bonded to the catheter through medical-grade adhesives, simplifying the production process and improving the connection performance.

[0021] The developer ring preparation tool provided by the present invention is easy to operate, can be reused, saves resources and costs, has a simple structure, is easy to disassemble, and can manufacture developer rings of different sizes by using ejector pins of different specifications and different numbers of sheets. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0023] Figure 1 It is a schematic structural diagram of the polymer developing ring 12 of the present invention.

[0024] Figure 2 and Figure 3 It is a schematic diagram of the tooling for preparing the developing ring of the present invention,

[0025] Figure 4 The present invention is a flow chart of the method for preparing a developing ring.

[0026] Figure 5 Schematic diagram of the application of the polymer developing ring of the present invention in medical equipment

[0027] In the figure, 1 is a first body; 2 is a second body; 3 is a first lever; 4 is a second lever; 5 is a third lever; 6 is a fourth lever; 7 is a left handle; 8 is a right handle; 9 is a left ejector pin; 10 is a right ejector pin; 11 is a molding die; 12 is a developing ring; 121 is a ring-shaped body; 122 is a pit structure; 13 is an inner catheter; 14 is a balloon body. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0029] Embodiment 1

[0030] refer to Figures 1 to 5 The present invention provides a developing ring 12, comprising an annular body 121 and a pit structure 122 on the inner surface; the outer surface of the annular body is cylindrical, the inner cavity is truncated cone, and the diameter of the inner cavity differs by 0.5-1mm. The inner surface of the polymer developing ring has regular pit structures 122 arranged along the circumference of the inner surface, and the shape is circular, elliptical, square or other regular polygons, and the pit depth is 0.2-0.5mm. The inner ring surface of the polymer developing ring of the present invention is designed to be truncated cone, and the regular pit structure 122 on the inner surface increases the contact area with the adhesive when connecting the catheter with the medical grade adhesive, thereby effectively improving the connection performance between the developing ring and the catheter.

[0031] The outer diameter of the annular structure is 2mm to 10mm, the inner diameter is 1mm to 8mm, and the wall thickness of the annular structure is 0.5mm to 4.5mm. The polymer developing ring of the present invention can flexibly adjust the processing technology according to different medical application scenarios and needs, including adjusting the ratio of polymer materials to developers to achieve the desired developing effect and physical properties. In addition, the preparation tooling of the present invention can customize the production of developing rings of different sizes by replacing ejector pins and shaping molds of different specifications to meet various medical needs, thereby improving the flexibility and efficiency of production.

[0032] The breaking strength of the polymer developing ring is greater than or equal to 40N, and the elastic modulus is less than or equal to 42GPa. Compared with the metal developing ring, the polymer developing ring of the present invention has a lower elastic modulus and exhibits good flexibility and elasticity. This characteristic enables the developing ring to better adapt to the complex shape of the blood vessel and improves its navigation performance in the blood vessel. The pits are arranged circumferentially along the truncated cone inner surface and are circular, elliptical, square or other regular polygonal shapes. When the developing ring and the catheter are connected using an adhesive, the contact area between the inner cavity of the developing ring and the adhesive can be increased to enhance the connection performance.

[0033] The annular body of the developing ring is made of a mixture of a polymer material and a developer. The polymer material is a thermoplastic polymer elastomer material, such as polyurethane, polyether block polyamide, nylon and the like.

[0034] The developer may be selected from materials with developing effects such as tungsten powder, barium sulfate, bismuth oxychloride, bismuth carbonate, etc. The developer may also be selected from nano-scale metal tungsten powder, which has a higher density and better absorption effect on X-rays, thereby enhancing the developing effect.

[0035] In addition, a preparation tool is provided, which can be used to prepare polymer developer rings more conveniently and quickly, and has good practicality and economy. Figure 2The figure shows the tooling for preparing the developing ring of the present invention, which is made of a metal material resistant to high temperature of 300°C and is used to fix and shape the polymer developing ring. The tooling for preparing the polymer developing ring includes a main body, a pressure component and a fixing component. The pressure component is used to apply pressure to fully discharge the air in the polymer developing ring. The fixing component is used to fix and form the shape of the developing ring. The material of the contact part between the fixing component and the developing ring is corrosion-resistant and can reduce the pollution to the developing ring. The main body includes a first main body 1 and a second main body 2 which are symmetrically arranged. The outer sides of the first main body 1 and the second main body 2 are respectively provided with a left handle 7 and a right handle 8; the pressure group is a scissor-type mechanism; the first main body 1 is connected to the second main body 2 through the scissor-type mechanism; the pressure component includes a first lever 3, a second lever 4, a third lever 5 and a fourth lever 6; 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 main body 1 and the second main body 2; the middle parts of the first lever 3, the second lever 4, the third lever 5 and the fourth lever 6 are movably connected with a support rod; the fixing component includes a left ejector pin 9, a right ejector pin 10 and a shaping mold 11; the left The ejector pin 9 and the right ejector pin 10 are slender circular tubes with an inner diameter of 1.5mm to 8.5mm and an outer diameter of 2mm to 10mm, and are used to fix the shaping mold 11; the shaping mold includes an outer mold and an inner mold; the outer mold is an equal-diameter metal tube, whose inner diameter is 0.1 to 0.4mm larger than the outer diameter of the target developing ring, and the wall thickness is 0.8mm to 1mm; the inner mold is composed of a flat round rod and 3 to 6 detachable thin sheets with protrusions on the surface, wherein the thin sheets can be combined into a circular tube structure along the axial direction, and the overall outer diameter of the circular tube structure is 0.1 to 0.5mm smaller than the inner diameter of the corresponding position of the target developing ring; the outer mold is 8mm to 10mm shorter than the inner mold as a whole, which is convenient for separating the inner and outer molds and the developing ring. (Reply: The thin sheets with protrusions form a circular tube structure, and then a flat round rod is placed inside the circular tube to form a cylindrical structure. The detachable structure is used to facilitate the removal of the developing ring after the shaping process of the developing ring is completed.)

[0036] like Figure 3 The inner mold of the shaping mold 11 of the fixed assembly shown is composed of a flat round rod and 3 to 6 detachable metal sheets with round, square or oval protrusions on the outer surface, which are used to make regular pits appear on the inner wall of the developing ring after molding. The sheets can be combined into a circular tubular structure along the axial direction.

[0037] like Figure 4 The specific implementation process of the developing ring preparation method of the present invention is shown, and the steps are as follows:

[0038] Step 1: Use a balance to weigh 4±0.02g polyurethane and 7±0.02g nano-tungsten powder respectively, first add 200±5ml organic solvent to completely dissolve the polyurethane, 30 minutes after dissolution, and then slowly pour the tungsten powder into the dissolved solution. The above process needs to be carried out at a temperature of 60°C and a speed of 250±10r / min until a particle-free, uniform mixed solution is formed. The above process requires strict control of the mass ratio and the order of material dissolution, and high-speed stirring is used throughout the process. The stirring and dissolving process needs to be carried out at a specific temperature, and the stirring speed must be accurately controlled to ensure the uniformity of the mixture.

[0039] Step 2: Use a 50mL syringe to accurately measure 30±1mL of the prepared solution and inject it into a glass dish with a length of 100mm, a width of 100mm, and a depth of 30mm. This process can accurately control 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 evaporation rate of the solvent and the formation of the film. The glass dish is placed in a hot oven preheated to 90°C and heated 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 part of the solvent and prevent the film from deforming during subsequent processing. The heating device can be a hot oven, a constant temperature water bath, etc.

[0040] Step 3: Take the heated and dried film out of the hot oven, and roll it evenly axially onto the inner mold of the shaping mold 11, then put the outer mold on, leaving a length of 4mm to 5mm at both ends of the inner mold, and then insert the two 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 slender cylindrical tubes, which are used to fix the shaping mold 11 and press the film to exhaust. The operator needs to hold the left handle 7 and the right handle 8 of the preparation tool with one hand, apply pressure to compress the film and exhaust as much excess air as possible. Then put the developing ring preparation tool into the heating device. In this embodiment, the heating device uses a hot oven, and the temperature is set to 200°C. The tool is placed in the hot oven as a whole and heated for 3 minutes to carry out the heating and shaping process of the developing ring to promote the curing of the mixed material. The heating device needs to have precise temperature control and uniform heat distribution, and the heating time needs to be precisely controlled during the heating process to achieve uniform molding of the film.

[0041] Step 4: After heating is completed, remove the tooling. After complete cooling, remove the shaped polymer developer ring from the left ejector pin 9 and the right ejector pin 10, and remove the round rods in the outer mold and the inner mold in turn. At this time, the thin slice of the fixed component is attached to the inner wall of the developer ring. It is necessary to separate the thin slice under a microscope to obtain the formed developer ring 12. Then the polymer developer ring is precisely cut to remove excess material, with a length of 4.5mm, and the edge is trimmed to ensure the surface quality of the developer ring, and the polymer developer ring 12 with an inner diameter of 2.5mm, an outer diameter of 3.5mm, and a wall thickness of 0.5mm is obtained. Figure 1 shown.

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

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

[0044]

[0045] like Figure 5 The application of the polymer developing ring 12 of the present invention in the balloon catheter is shown, which is specifically applied to the aortic counterpulsation balloon for treating heart failure. In this embodiment, the polymer developing ring 12 is fixed at the distal end of the balloon, located between the inner catheter 13 and the balloon body 14, including an inner ring surface and an outer ring surface, wherein the inner ring surface of the developing ring 12 and the inner catheter 13 of the balloon catheter are tightly fitted by medical-grade glue, and the outer ring surface of the developing ring 12 is tightly fitted with the balloon 14 by medical-grade glue. Because of the specific shape of the developing ring and the pits on the inner surface, the contact area of ​​the glue is increased, thereby enhancing the connection performance between the developing ring and the catheter, and can avoid the phenomenon of the developing ring slipping off the catheter. At the same time, the polymer developing ring of the present invention contains a developer. In this embodiment, nano-scale tungsten powder is used, which has a high density and a good X-ray absorption effect, and can effectively enhance the developing effect. In addition, the ratio of tungsten powder and polyurethane can be adjusted according to the usage scenario so that its developing effect and elasticity meet different usage requirements.

[0046] After the balloon catheter is placed in the patient's blood vessels, it is developed using X-ray imaging technology, and the polymer development ring can help doctors confirm the position of the balloon catheter. And according to the development results, the position of the balloon can be appropriately adjusted until the expected target position is reached.

[0047] Embodiment 2

[0048] like Figure 4The specific implementation process of the developing ring preparation method of the present invention is shown, and the steps are as follows:

[0049] Step 1: Use a balance to weigh 4±0.02g of polyether block polyamide and 8±0.02g of barium sulfate, first add 200±5ml of organic solvent to completely dissolve the polyether block polyamide, and then slowly pour the barium sulfate into the dissolved solution 30 minutes after dissolution. The above process needs to be carried out at a temperature of 80°C and a speed of 250±10r / min until a particle-free, uniform mixed solution is formed. The above process requires strict control of the mass ratio and the order of material dissolution, and high-speed stirring is used throughout the process. The stirring and dissolving process needs to be carried out at a specific temperature, and the stirring speed must be accurately controlled to ensure the uniformity of the mixture.

[0050] Step 2: Use a 50mL syringe to accurately measure 30±1mL of the prepared solution and inject it into a glass dish with a length of 100mm, a width of 100mm, and a depth of 30mm. This process can accurately control 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 evaporation rate of the solvent and the formation of the film. The glass dish is placed in a hot oven preheated to 100°C and heated 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 part of the solvent and prevent the film from deforming during subsequent processing. The heating device can be a hot oven, a constant temperature water bath, etc.

[0051] Step 3: Take out the heated and dried film from the hot oven, and roll it evenly axially onto the inner mold of the shaping mold 11, then put on the outer mold, leaving a length of 4mm to 5mm at both ends of the inner mold, and then insert the two ends of the inner mold into the left ejector pin 9 and the right ejector pin 10 respectively. The operator needs to hold the left handle 7 and the right handle 8 of the preparation tool with one hand, apply pressure to compress the film and expel as much excess air as possible. Then put the developing ring preparation tool into the heating device. In this embodiment, the heating device uses a hot oven with a temperature set to 220°C. Put the tool as a whole into the hot oven and heat it for 5 minutes to carry out the heating and shaping process of the developing ring to promote the curing of the mixed material. The heating device needs to have precise temperature control and uniform heat distribution, and the heating time needs to be precisely controlled during the heating process to achieve uniform molding of the film.

[0052] Step 4: After heating is completed, remove the tooling. After complete cooling, remove the shaped polymer developer ring from the left ejector pin 9 and the right ejector pin 10, and remove the round rods in the outer mold and the inner mold in turn. At this time, the thin slice of the fixed component is attached to the inner wall of the developer ring. It is necessary to separate the thin slice under a microscope to obtain the formed developer ring 12. Then the polymer developer ring is precisely cut to remove excess material, with a length of 4.5mm, and the edge is trimmed to ensure the surface quality of the developer ring, and the polymer developer ring 12 with an inner diameter of 2.5mm, an outer diameter of 3.5mm, and a wall thickness of 0.5mm is obtained. Figure 1 shown.

[0053] Embodiment 3

[0054] like Figure 4 The specific implementation process of the developing ring preparation method of the present invention is shown, and the steps are as follows:

[0055] Step 1: Use a balance to weigh 4±0.02g nylon and 4±0.02g bismuth carbonate respectively, first add 200±5ml organic solvent to completely dissolve the nylon, 30 minutes after dissolution, then slowly pour the bismuth carbonate into the dissolved solution, the above process needs to be carried out at 70℃ and 250±10r / min, until a particle-free, uniform mixed solution is formed. The above process needs to pay attention to the strict control of the mass ratio and the order of material dissolution, and use high-speed stirring throughout the process. The stirring and dissolving process needs to be carried out at a specific temperature, and the stirring speed must be accurately controlled to ensure the uniformity of the mixture.

[0056] Step 2: Use a 50mL syringe to accurately measure 30±1mL of the prepared solution and inject it into a glass dish with a length of 100mm, a width of 100mm, and a depth of 30mm. This process can accurately control 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 evaporation rate of the solvent and the formation of the film. The glass dish is placed in a hot oven preheated to 95°C and heated 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 part of the solvent and prevent the film from deforming during subsequent processing. The heating device can be a hot oven, a constant temperature water bath, etc.

[0057] Step 3: Take out the heated and dried film from the hot oven, and roll it evenly axially onto the inner mold of the shaping mold 11, then put on the outer mold, leaving a length of 4mm to 5mm at both ends of the inner mold, and then insert the two ends of the inner mold into the left ejector pin 9 and the right ejector pin 10 respectively. The operator needs to hold the left handle 7 and the right handle 8 of the preparation tool with one hand, apply pressure to compress the film and expel as much excess air as possible. Then put the developing ring preparation tool into the heating device. In this embodiment, the heating device uses a hot oven with a temperature set to 120°C. Put the tool as a whole into the hot oven and heat it for 10 minutes to carry out the heating and shaping process of the developing ring to promote the curing of the mixed material. The heating device needs to have precise temperature control and uniform heat distribution, and the heating time needs to be precisely controlled during the heating process to achieve uniform molding of the film.

[0058] Step 4: After heating is completed, remove the tooling. After complete cooling, remove the shaped polymer developer ring from the left ejector pin 9 and the right ejector pin 10, and remove the round rods in the outer mold and the inner mold in turn. At this time, the thin slice of the fixed component is attached to the inner wall of the developer ring. It is necessary to separate the thin slice under a microscope to obtain the formed developer ring 12. Then the polymer developer ring is precisely cut to remove excess material, with a length of 4.5mm, and the edge is trimmed to ensure the surface quality of the developer ring, and the polymer developer ring 12 with an inner diameter of 2.5mm, an outer diameter of 3.5mm, and a wall thickness of 0.5mm is obtained. Figure 1 shown.

[0059] What is described above is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A polymer developing ring and its preparation tool, characterized in that: The invention comprises a polymer developing ring (12) and a preparation tool; the polymer developing ring (12) comprises an annular main body (121) and a concave structure (122) on its inner surface; the annular main body (121) is made of a mixture of a polymer material and a developer; the outer surface of the annular main body (121) is cylindrical, and the inner cavity is truncated; the polymer developing ring preparation tool comprises a main body, a pressure component and a fixing component; the pressure component is used to apply pressure to fully discharge the air in the polymer developing ring; the fixing component is used to fix and form 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; the outer sides of the first main body (1) and the second main body (2) are respectively provided with a left handle (7) and a right handle (8); the pressure group is a scissor-type mechanism; the first main body (1) is connected to the second main body (1) through the scissor-type mechanism The fixing assembly comprises a left ejector pin (9), a right ejector pin (10) and a shaping mold (11); the left ejector pin (9) and the right ejector pin (10) are slender cylindrical tubes with inner diameters of 1.5 mm to 8.5 mm and outer diameters of 2 mm to 10 mm, and are used to fix the shaping mold (11); the shaping mold (11) comprises an outer mold and an inner mold; the outer mold is a metal tube of equal diameter, with an inner diameter of 0.1 to 0.4 mm larger than the outer diameter of a target developing ring and a wall thickness of 0.8 mm to 1 mm; the inner mold is composed of a flat round rod and 3 to 6 detachable thin sheets with protrusions on the surface, wherein the thin sheets can be combined into a cylindrical structure along the axial direction, and the overall outer diameter of the cylindrical structure is 0.1 to 0.5 mm smaller than the inner diameter of the corresponding position of the target developing ring; the outer mold is 8 mm to 10 mm shorter than the inner mold as a whole, so as to facilitate separation of the inner and outer molds and the developing ring.

2. A method for preparing a polymer developing ring, characterized in that: The preparation tooling according to claim 1 is used to prepare the developing ring according to claim 1, comprising the following steps: Step 1: Prepare polymer material and developer in a mass ratio of 1:2 to 1:1, and completely dissolve the polymer material in an organic solvent at 60°C-80°C and a constant speed of 250±10r / min, wait for at least 30 minutes, then add the developer and mix evenly; Step 2: using a coating device to evenly coat the mixed solution of the polymer material and the developer on the substrate to form a thin film, and drying it at 90° C. to 100° C. for more than 12 hours; Step 3: The heated and dried film is rolled evenly onto the inner mold of the shaping mold (11), and then the outer mold is put on, leaving a length of 4 mm to 5 mm at both ends of the inner mold, and then the two ends of the inner mold are respectively inserted into the left ejector pin (9) and the right ejector pin (10); pressure is applied to the positions of the left handle (7) and the right handle (8) of the preparation tool to exhaust, and then the film and the preparation tool are placed in a heating device at 120° C. to 220° C. and kept for 3 min to 10 min to shape into a polymer development ring; Step 4: After the polymer developing ring is cooled, it is removed from the preparation tooling, and the round rods in the outer mold and the inner mold are removed in turn. Then, the thin sheet of the inner mold is separated from the inner wall of the developing ring under a microscope, and finally the developing ring is subjected to subsequent processing, including cutting to remove excess material and trimming the edges.

3. The polymer developing ring and the tooling for preparing the same according to claim 1, characterized in that: The pits are arranged circumferentially along the truncated cone-shaped inner surface, and the shape of the pits is one of circular, elliptical and square.

4. The polymer developing ring and the tooling for preparing the same according to claim 1, characterized in that: The polymer material is a mixture of one or more of polyurethane, polyether block polyamide and nylon.

5. The polymer developing ring and the tooling for preparing the same according to claim 1, characterized in that: The developer is a mixture of one or more of tungsten powder, barium sulfate, bismuth oxychloride and bismuth carbonate.

6. The polymer developing ring and the tooling for preparing the same according to claim 1, characterized in that: The protrusions of the metal sheet contained in the shaping die (11) for preparing the tooling have a shape selected from the group consisting of a circle, an ellipse and a square.

7. The polymer developing ring and the tooling for preparing the same according to claim 1, characterized in that: The pressure assembly comprises a first lever (3), a second lever (4), a third lever (5) and a fourth lever (6); two ends of the first lever 3, the second lever 4, the third lever 5 and the fourth lever 6 are movably connected to two ends of the first body (1) and the second body (2) respectively; and a support rod is movably connected through the middle of the first lever (3), the second lever (4), the third lever (5) and the fourth lever (6).

8. Application of a polymer developing ring in a balloon catheter, characterized in that: A developing ring prepared by the preparation tooling and preparation method described in any one of claims 1 to 7; comprising an inner catheter (13) and a balloon body (14); the inner catheter (13) passes through the developing ring, and the developing ring is sleeved and fixedly connected between the inner catheter (13) and the balloon body (14); the inner ring surface of the developing ring (12) is tightly fitted to the inner catheter (13) of the balloon catheter by medical grade glue, and the outer ring surface of the developing ring (12) is tightly fitted to the balloon body (14) by medical grade glue.

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