Integrated forming equipment and forming method for medical composite catheter body

Abstract

The invention belongs to the technical field of machining and forming of implantable medical instruments, and relates to integrated forming equipment and method for a medical composite catheter body. The equipment provided by the invention comprises a frame, an electrical cabinet, a forming device and a transmission device, the forming device is provided with a forming processing module composed of a hot air module and a heat shrink tube stripping module. The transmission device is provided with a synchronous control module and pipe body head end clamping modules, and the pipe body head end clamping modules and the forming processing modules are the same in number and arranged in pairs. And putting the assembled tube body containing the lining core into equipment, setting process parameters, heating, compounding and integrally forming the inner layer, the metal layer and the outer layer of the tube body containing the lining core, synchronously stripping a heat shrink tube, and finally pulling out the lining core to obtain the medical composite catheter body. According to the device, thermal forming of pipe bodies of various materials and structures and stripping of heat shrink pipes can be synchronously completed on one device, the number of procedures and the number of workers can be reduced, operation is easy, time and labor are saved, and cost is saved for enterprises.

Description

Technical Field

[0001] The present invention belongs to the technical field of processing and forming of implantable medical devices, and relates to an integrated forming device and a forming method for a medical composite catheter tube body. Background Art

[0002] Composite catheters are widely used in the field of implantable medical treatment. A good catheter needs to have good flexibility to facilitate entry into tortuous blood vessels, and also needs to have good hardness to facilitate transmission of proximal pushing force to the distal end. Currently, composite catheters widely use three-layer or four-layer structures. The three-layer composite catheters are inner layer, single metal layer, and outer layer from the inside to the outside; the four-layer composite catheters are inner layer, composite metal layer (i.e. braided layer + spring layer), and outer layer from the inside to the outside. In some other composite catheters, the positions of the spring layer and the braided layer can also be interchanged; or a four-layer structure is used at the distal end and a three-layer structure is used at the proximal end.

[0003] At present, heat shrink tubing is required in the process of forming composite conduits. The heat shrink tubing is used to combine the multiple layers of the composite conduit together by heating. After the conduit is formed, the heat shrink tubing used for forming needs to be removed.

[0004] Regarding the removal of heat shrink tubes, patent document CN 212445353U discloses a heat shrink tube stripping device, including a knife holder and a pressing plate for fixing a blade on the knife holder, a guide support mechanism is provided on the knife holder, and the guide support mechanism is arranged corresponding to the position of the knife blade; through the cooperation of the knife blade, the guide support mechanism and the working chamber, it is not necessary for a person to hold the knife blade to cut the heat shrink tube, as long as the heat shrink tube is placed between the knife blade and the guide support mechanism, and then the heat shrink tube passes through the working chamber formed by the knife holder and the pressing plate, the heat shrink tube can be easily cut, and the medical composite catheter will not be damaged. Patent document CN217096205U discloses a heat shrink tube stripping device for medical catheters, including a base, a tube clamping seat and a cutting piece, the base has a positioning groove, and the tube clamping seat is embedded in the positioning groove of the base to realize the positioning of the tube clamping seat; the surface of the tube clamping seat has a strip groove with a cross-section of a dovetail groove structure, and the opening width of the strip groove is smaller than the outer diameter of the heat shrink tube to clamp the heat shrink tube; the cutting piece is used to cut along the axial direction of the heat shrink tube. The device uses the strip groove with a dovetail groove structure on the surface of the clamp seat to clamp the heat shrink tube, which can quickly and effectively fix the circular heat shrink tube and prevent the heat shrink tube from slipping and accidentally moving. Although the existing device can peel off the heat shrink tube, it cannot peel off the variable diameter catheter, and manual additional peeling is required. The peeling and composite molding processes are separated, which increases the product process and labor, and the cost is high. In addition, easy-to-tear heat shrink tubes can be used, but their cost is about 80-90 yuan / meter, which is expensive, resulting in a significant increase in the cost of catheter products.

[0005] Therefore, how to simply and at low cost realize the integral molding of a composite catheter body, especially the integral molding of a variable diameter catheter body, is a difficult problem that needs to be solved urgently. Summary of the invention

[0006] Based on this, the purpose of the present invention is to provide a medical composite catheter tube one-piece molding device, which can achieve the technical effect of heating the inner layer, metal layer and outer layer of the composite catheter tube body into one piece, and simultaneously peeling off the heat shrink tube.

[0007] The invention also provides a method for integrally forming a medical composite catheter body based on the device.

[0008] To achieve the above object, the present invention adopts the following technical solutions: The present invention provides a medical composite catheter tube body integrated molding device, comprising a frame 1 and an electrical box 4, characterized in that it also includes a molding device 2 and a transmission device 3; the molding device 2 includes a hot air fixing plate 201, and the hot air fixing plate 201 is provided with a molding processing module composed of a hot air module 218 and a heat shrink tube stripping module; the transmission device 3 includes a fixed frame 301, and the fixed frame 301 is installed with a tube head end clamping module and a synchronous control module; the tube head end clamping module and the molding processing module are the same in number and are arranged in pairs; the synchronous control module includes a synchronous belt 313, and the synchronous belt 313 is provided with a synchronous belt connecting block 314, and the molding device 2 is fixedly connected to the transmission device 3 through the synchronous belt connecting block 314.

[0009] Furthermore, the hot air module 218 has a hollow heating cavity, and the heating cavity is used for forming the tube body; the heat shrink tube stripping module includes a guide plate 216 and a guide sleeve 217 threadedly connected to the guide plate 216, and the guide sleeve 217 is provided with a through hole for placing the tube body, and the inner diameter of the through hole matches the outer diameter of the tube body to be formed. There are a number of uniform small holes 219 on the hollow heating cavity of the hot air module 218, and there are also a heating device and a temperature sensor inside the hot air module 218. The heating wire in the heating device is used for gas heating, and the temperature sensor is used for temperature regulation to stabilize it at a constant temperature. The equipment is connected to an air source, and the gas of the air source enters the hot air module 218 through the air path channel, and is heated by the heating device and then blown out from the small hole 219 for heating and forming the tube body.

[0010] Furthermore, the guide plate 216 is provided with a winding motor 205 and a motor fixing plate 206 connected thereto by bolts, the transmission shaft of the winding motor 205 is connected to the active rotating shaft 213 by a coupling 207, and the active rotating shaft 213 is bolted to the active winding gear 208 and the active winding wheel 215 respectively; the active winding gear 208, the active winding wheel 215 and the active rotating shaft 213 are arranged in pairs with the driven winding gear 209, the driven winding wheel 214 and the driven rotating shaft 212 respectively. The driven winding wheel 214 is bolted to the driven rotating shaft 212, and the driven winding gear 209 is bolted to the driven rotating shaft 212. The active rotating shaft fixing block 211 is connected to the active rotating shaft 213, and the driven rotating shaft fixing block 210 is connected to the driven rotating shaft 212 respectively by bearings.

[0011] Furthermore, the hot air module 218, the guide plate 216 and the winding motor 205 are respectively fixedly connected to the hot air fixing plate 201. The hot air fixing plate 201 is provided with a threading hole 204. The motor wire of the winding motor 205 passes through the threading hole 204 and is connected to the electrical box 4.

[0012] Furthermore, the tube head end clamping module includes an air gripper fixing plate 307, a clamp switch 308, a cylinder 309 and a clamp 310 fixedly connected to the fixing frame 301; the clamp switch 308 is fixedly connected to the air gripper fixing plate 307, and is connected to the cylinder 309 through an air rope; the clamp 310 is composed of two tube body fixing plates, and is fixedly connected to the cylinder 309, and a gap is left between the tube body fixing plates to accommodate the tube head end.

[0013] Furthermore, the synchronous control module mainly includes a synchronous belt 313, a synchronous wheel 304 and a synchronous motor 306; the synchronous belt 313 is sleeved on the synchronous wheel 304; the synchronous motor 306 is fixedly connected to the fixed frame 301 through a motor fixing block 312, and the transmission shaft of the motor is connected to the synchronous belt shaft 303 through a coupling 305; the synchronous belt shaft 303 is fixedly connected to the bearing seat 311 through a bearing, and the bearing seat 311 is fixedly connected to the fixed frame 301 through a bearing seat fixing block 302, and the synchronous wheel 304 and the synchronous belt shaft 303 are connected by interference fit of bolts.

[0014] Furthermore, the head end of the synchronous belt 313 is connected to a synchronous belt connecting block 314, and the tail end is connected to a counterweight plate 316; a sliding connection block fixing plate 202 and a sliding connection block 203 are provided behind the hot air fixing plate 201 of the forming device 2, the sliding connection block fixing plate 202 is fixedly connected to the hot air fixing plate 201, the sliding connection block 203 is fixedly connected to the sliding connection block fixing plate 202, and the sliding connection block 203 is fixedly connected to the synchronous belt connecting block 314 by snapping or plugging.

[0015] The present invention also provides a method for integrally forming a medical composite catheter body, comprising the following steps: S1, putting the inner layer of the tube body on the liner core, and then assembling the metal layer, the outer tube and the heat shrink tube in sequence to obtain a tube body containing the liner core; S2, start the medical composite catheter tube body integrated molding device according to any one of claims 1 to 7, turn on the synchronous motor 306, move the molding device 2 to just below the fixed frame 301 in the transmission device 3, so that the molding processing module and the tube head end clamping module correspond one to one in the upper and lower parts; S3, turn off the synchronous motor 306, tear off the outermost heat shrink tube at the head end of the tube body containing the liner core in S1, and then pass it through the hot air module 218 and the guide sleeve 217 in sequence, and then clamp and fix the part of the head end not covered with the heat shrink tube by the clamp 310, and the torn heat shrink tube at the head end is wound around the active winding wheel 215 and the driven winding wheel 214; preferably, a suitable counterweight can be added to the lower end of the tube body containing the liner core so that the tube body can be kept in a vertical state; S4, set the composite temperature of the hot air module 218, the moving speed of the forming device 2 and the reeling speed of the reeling motor 205 through the electrical box 4; turn on the reeling motor 205 and the synchronous motor 306 at the same time, control the forming processing device 2 to move toward the lower end of the tube body containing the liner core, and the hot air module 218 heats the inner layer, the metal layer and the outer layer of the tube body containing the liner core for composite molding, while the active reeling wheel 215 and the driven reeling wheel 214 reel the peeled heat shrink tube; S5, taking out the tube body containing the liner core after the heat shrink tube is stripped off and removed in S4 from the medical composite catheter tube body integrally forming device, and extracting the liner core to obtain the integrally formed medical composite catheter tube body.

[0016] Furthermore, the composite process parameters are that the composite temperature is 170-250° C., the moving speed of the forming device 2 is 0.1-10.0 mm / s, preferably 0.1-3.0 mm / s; the winding speed of the winding motor 205 is 0.1-10.0 mm / s, preferably 0.1-3.0 mm / s.

[0017] Furthermore, the medical composite catheter includes a microcatheter, a biliary stent outer tube, an angiography catheter, a guide sheath, a multi-layer composite anesthesia catheter or a guide catheter.

[0018] The beneficial effects of the present invention are: 1. The equipment provided by the present invention contains a hot air module and a heat shrink tube stripping module, which can realize the composite thermoforming of the composite catheter and the stripping of the heat shrink tube in one device, thereby reducing the number of processes and workers, and is simple to operate, saving time and labor, and saving costs for the enterprise.

[0019] 2. The number of the tube head end clamping modules and the forming processing modules in the equipment provided by the present invention can be configured according to actual production needs, and the number can range from a few to hundreds, or even more. The machine can be started once to achieve synchronous processing of large quantities of tubes, with a high degree of automation. The performance consistency of the tubes after forming is good, which improves product yield and greatly reduces production costs.

[0020] 3. The equipment provided by the present invention is suitable for the integrated molding of composite catheter bodies of various structures including variable-diameter catheter bodies. It has strong universality and effectively solves the technical problem that catheters of different structures need to be separately configured with molding equipment, which can reduce equipment investment costs and improve production efficiency.

[0021] 4. The present invention heats the heat shrinkable tube, especially the heat shrinkable tube that is not easy to tear, so that the heat shrinkable tube is in better performance, and then peeled off, the heat shrinkable tube is not easy to break, thereby solving the technical problem that if the heat shrinkable tube that is not easy to tear is directly torn without heating, the tube body is prone to breakage, which increases the difficulty of peeling. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solution of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0023] Attached Figure 1 This is the overall front view of the medical composite catheter tube body one-piece molding equipment; Attached Figure 2 This is a three-dimensional diagram of the internal structure of the medical composite catheter tube body integrated molding equipment; Attached Figure 3 This is a structural diagram of a molding device in a medical composite catheter tube body integral molding device; Attached Figure 4 It is a rear view of the molding device structure in the medical composite catheter tube body integral molding equipment; Attached Figure 5 This is a structural diagram of a molding processing module in a medical composite catheter tube body integrated molding device; Attached Figure 6 This is the overall structure diagram of the transmission device in the medical composite catheter tube body integrated molding equipment; Attached Figure 7 This is a diagram of the upper structure of the transmission device in the medical composite catheter tube body integral molding equipment; Attached Figure 8 This is a diagram of the lower structure of the transmission device in the medical composite catheter tube body integral molding equipment; Attached Fig. 9 This is a structural diagram of a tube head end clamping module in a medical composite catheter tube body integrated molding device; Attached Fig.10 It is a schematic diagram of the head end of the tube body clamping module when the tube body including the liner core is integrally formed; Attached Fig.11 It is a schematic diagram of the state of the tube body in the molding device when the tube body including the liner core is integrally molded; Attached Fig.12 The microcatheter body in Example 1 is a structural diagram before and after molding; Attached Fig.13 This is a structural diagram of the outer tube body of the biliary stent in Example 2 before and after molding; Attached Fig.14 The structure diagram of the angiography catheter tube body before and after molding in Example 3; Attached Fig.15 This is a structural diagram of the guide sheath tube body before and after molding in Example 4; Attached Fig.16 This is a structural diagram of the multi-layer composite anesthesia catheter tube body before and after molding in Example 5; Attached Fig.17 This is a structural diagram of the guide catheter body before and after molding in Example 6; In the figure, 1 is a frame, 2 is a forming device, 3 is a transmission device, 4 is an electrical box, 201 is a hot air fixing plate, 202 is a sliding connection block fixing plate, 203 is a sliding connection block, 204 is a threading hole, 205 is a winding motor, 206 is a motor fixing plate, 207 is a coupling, 208 is an active winding gear, 209 is a driven winding gear, 210 is a driven shaft fixing block, 211 is a driving shaft fixing block, 212 is a driven shaft, 213 is a driving shaft, 214 is a driven winding wheel, 215 is an active Winding wheel, 216 is the guide plate, 217 is the guide sleeve, 218 is the hot air module, 219 is the small hole, 301 is the fixed frame, 302 is the bearing seat fixing block, 303 is the synchronous belt shaft, 304 is the synchronous wheel, 305 is the coupling, 306 is the synchronous motor, 307 is the air claw fixing plate, 308 is the clamp switch, 309 is the cylinder, 310 is the clamp, 311 is the bearing seat, 312 is the motor fixing block, 313 is the synchronous belt, 314 is the synchronous belt connecting block, 315 is the frame center column, and 316 is the counterweight plate. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. The embodiments mentioned are all implemented on the premise of the technical solutions of the present invention, and detailed implementation processes are given, but it should be stated that the protection scope of the present invention is not limited to the following embodiments.

[0025] The medical composite catheter tube body integrated molding equipment provided by the present invention can achieve the technical effect of simultaneously peeling off the heat shrink tube while heating and composite molding the inner layer, metal layer (a single metal layer or a composite metal layer formed by a braided layer + a spring layer) and outer layer of the composite catheter tube body.

[0026] like Figure 1 As shown, the equipment includes a frame 1 and an electrical box 4 installed on the outer surface of the frame 1. The frame 1 is composed of profiles and acrylic panels. The front door can be a double door, and the other sides can be fixed door panels. A control panel is installed on the electrical box 4 for setting various process parameters of the equipment. The control panel can select a touch screen panel.

[0027] like Figure 2 As shown, the device also includes a forming device 2 and a transmission device 3, and the forming device 2 is fixed on the transmission device 3. The structure of the forming device 2 and its core components is as shown in FIG. Figure 3-5 As shown, the structure of the transmission device 3 and its core components is as follows Figure 6-9 shown.

[0028] like Figure 3 As shown, the forming device 2 includes a hot air fixing plate 201, on which a forming processing module is provided, the forming processing module is composed of a hot air module 218 and a heat shrink tube stripping module, the heat shrink tube stripping module mainly includes a guide plate 216 and a winding motor 205, and a guide sleeve 217 is threadedly connected to the guide plate 216, and the guide sleeve 217 is provided with a through hole for placing the tube body, and the inner diameter of the through hole matches the outer diameter of the tube body to be formed. The hot air module 218, the guide plate 216 of the heat shrink tube stripping module and the winding motor 205 are respectively fixed to the hot air fixing plate 201 by bolts. A threading hole 204 is provided on the hot air fixing plate 201, and the motor line of the winding motor 205 passes through the threading hole 204 and is connected to the electrical box 4.

[0029] like Figure 4 As shown, a sliding connection block fixing plate 202 and a sliding connection block 203 are provided behind the hot air fixing plate 201, the sliding connection block fixing plate 202 is connected to the hot air fixing plate 201 by bolts, and the sliding connection block 203 is connected to the sliding connection block fixing plate 202 by bolts.

[0030] like Figure 5As shown, the hot air module 218 of the molding device 2 has a hollow heating cavity, which is used to heat and mold the tube body. There are a number of uniform small holes 219 on the hollow heating cavity, and there are also heating devices and temperature sensors inside the hot air module 218. The heating wire in the heating device is used for gas heating, and the temperature sensor is used for temperature regulation to stabilize it at a constant temperature. The device is connected to an air source, and the gas from the air source enters the hot air module 218 through the air path channel, and is heated by the heating device and then blown out from the small holes 219 for heating and molding the tube body.

[0031] The guide plate 216 of the heat shrink tube stripping module is also provided with a winding motor 205, a motor fixing plate 206 and a winding wheel connected thereto by bolts. The winding wheel includes an active winding wheel 215 and a driven winding wheel 214, and the heat shrink tube after stripping is wound on the winding wheel. The transmission shaft of the winding motor 205 is connected to the active rotating shaft 213 through a coupling 207, and the active rotating shaft 213 is bolted to the active winding gear 208 and the active winding wheel 215 respectively; the active winding gear 208, the active winding wheel 215 and the active rotating shaft 213 correspond to the driven winding gear 209, the driven winding wheel 214 and the driven rotating shaft 212 respectively, and are arranged in pairs. The driven rotating shaft 212, the driven winding wheel 214 and the driven rotating shaft 212 are fixed by bolts, and the driven winding gear 209 and the driven rotating shaft 212 are fixed by bolts. The driving shaft fixing block 211 and the driving shaft 213 , and the driven shaft fixing block 210 and the driven shaft 212 are connected via bearings respectively.

[0032] When in use, the transmission shaft of the winding motor 205 drives the active rotating shaft 213 to drive the active winding gear 208 to rotate, and then drives the driven winding gear 209 to rotate, thereby driving the active winding wheel 215 and the driven winding wheel 214 to rotate. The peeled heat shrink tube is respectively wound around the active winding wheel 215 and the driven winding wheel 214 to complete the winding.

[0033] like Figures 6 to 8 As shown, the transmission device 3 includes a frame center column 315, the lower end of which is fixedly mounted on the lower surface of the frame 1, and the upper end of the frame center column 315 is fixed with a fixing frame 301, on which a tube head end clamping module and a synchronous control module are provided.

[0034] The synchronous control module mainly includes a synchronous motor 306, a synchronous wheel 304, and a synchronous belt 313. The synchronous motor 306 is threadedly connected to the fixed frame 301 through the motor fixing block 312, and the drive shaft of the motor is rotationally connected to the synchronous belt shaft 303 through the coupling 305; the synchronous belt shaft 303 is connected to the bearing seat 311 through a bearing, the bearing seat 311 is connected to the fixed frame 301 through the bearing seat fixing block 302, and the synchronous wheel 304 and the synchronous belt shaft 303 are connected through bolt interference fit. The synchronous belt 313 is sleeved on the synchronous wheel 304, and the head end of the synchronous belt 313 is connected to the synchronous belt connecting block 314, and the tail end is connected to the counterweight plate 316. The sliding connection block 203 (such as Figure 4 ) is fixedly connected to the synchronous belt connecting block 314 by snapping or plugging.

[0035] When in use, the transmission shaft of the synchronous motor 306 drives the synchronous belt shaft 303 to drive the synchronous wheel 304 to rotate, and the synchronous wheel 304 drives the synchronous belt 313 to rotate, so that the molding device 2 connected to the synchronous belt connecting block 314 moves up and down.

[0036] The structure of the pipe head end clamping module is as follows: Fig. 9 As shown, the module includes an air gripper fixing plate 307, which is bolted to the fixing frame 301. It also includes a clamp 310, a clamp switch 308 and a cylinder 309. The clamp switch 308 is connected to the cylinder 309 through an air rope and is fixedly connected to the air gripper fixing plate 307 through bolts; the clamp 310 is fixed to the cylinder 309 by bolts, and is composed of two tube body fixing plates. There is a gap between the two tube body fixing plates to accommodate the head end of the tube body. When in use, the head end of the tube body is first placed in the gap, and the clamp switch 308 is turned to be in a closed state, and the cylinder 309 drives the clamp 310 to close and clamp the head end of the tube body. The clamp switch 308 is turned to be in an open state, and the cylinder 309 drives the clamp 310 to open, and the tube body can be taken out.

[0037] The tube head end clamping module in the transmission device 3 corresponds to the molding processing module on the molding device 2 (eg Figure 2 ), the two are the same in number and are set in pairs. The number of the two is configured according to actual production needs, which can be from a few to hundreds, or even more. They can be processed at multiple stations to improve production efficiency and product yield.

[0038] The method for integrally forming a medical composite catheter body by using the equipment provided by the present invention mainly comprises the following steps: S1, prepare the lining core, put the inner layer of the tube body on the lining core, and then assemble the metal layer, the outer tube and the heat shrink tube in sequence to obtain the tube body with lining core. Because the tube body to be formed is a hollow tube body, the lining core is required for support before forming; S2, start the medical composite catheter tube body integrated molding device through the electrical box 4, turn on the synchronous motor 306, move the molding device 2 to the bottom of the fixed frame 301 in the transmission device 3, so that the molding processing module and the tube head end clamping module correspond one to one up and down; S3, turn off the synchronous motor 306, tear a small hole in the outermost heat shrink tube of the head end of the liner tube body in S1, and then pass it through the hot air module 218 and the guide sleeve 217 in sequence, and then clamp and fix the part of the head end not covered with the heat shrink tube by the clamp 310 (such as Fig.10 ), the heat shrink tube with the torn head end is wound around the active winding gear 215 and the driven winding gear 214 (such as Fig.11 ); Preferably, a suitable counterweight may be added to the lower end of the tube body containing the liner core so as to keep the tube body in a vertical state; S4, set the integrated molding process parameters through the electrical box 4: the composite temperature of the hot air module 218 is 170-250°C; the moving speed of the molding device 2 is 0.1-10.0mm / s, preferably 0.1-3.0mm / s; the winding speed of the winding motor 205 is 0.1-10.0mm / s, preferably 0.1-3.0mm / s. Turn on the winding motor 205 and the synchronous motor 306 at the same time, and the molding processing device 2 starts to move downward, heating the inner layer, the metal layer and the outer layer of the tube body containing the lining core for composite molding, while using the residual heat to tear and peel off the heat shrinkable tube, and the peeled heat shrinkable tube is wound on the winding wheel, completing the molding of the tube body containing the lining core and the synchronous peeling of the heat shrinkable tube; S5, taking out the tube body containing the liner core after the heat shrink tube is stripped off and removed in S4 from the medical composite catheter tube body integral molding equipment, and extracting the liner core to obtain the medical composite catheter tube body.

[0039] The conduit body formed by this method does not need to be stripped of the heat shrink tube separately. Since the integral molding temperature is between 170-250°C, the tube body has residual heat after heating, and the hot air module 218 will also emit heat upward during the heating process, so that the heat shrink tube is kept in a suitable temperature environment, making it easier to strip synchronously.

[0040] The medical composite catheters that can be integrally formed in the present invention include microcatheters, biliary stent sheaths, angiography catheters, guide sheaths, multi-layer composite anesthesia catheters, guide catheters and other implantable medical catheters. Figures 12 to 17 As shown, the catheter body can be a three-layer or four-layer structure. The three-layer composite catheter body is an inner layer, a metal layer, and an outer layer from the inside to the outside; the four-layer composite catheter body is an inner layer, a braided layer, a spring layer, and an outer layer from the inside to the outside; in some other composite catheters, the positions of the spring layer and the braided layer can also be interchanged; or a four-layer structure is used at the distal end and a three-layer structure is used at the proximal end.

[0041] When the composite catheter body is formed, the lining core in the middle is reasonably configured according to the structure and material of the tube body, which can be variable or non-variable, and the lining core material can be polyoxymethylene POM, coated stainless steel, copper, polytetrafluoroethylene and other materials. The inner layer of the composite catheter can be extruded on the lining core, or a separate inner layer can be sleeved on the lining core, and the material of the inner layer can be polytetrafluoroethylene, nylon, polyurethane and the like. The metal layer can be a one-layer or two-layer structure, the one-layer structure can be a separate braided structure or a spring structure, the two-layer structure can be a braided structure and a spring structure throughout the catheter body, or a braided and spring structure is used at the distal end, and a separate braided structure or a spring structure is used at the proximal end. The braided structure is woven by a braiding machine, and the spring structure is formed by a spring winding machine. The outer tube can be of the same hardness, or multiple sections of different hardness, and can be of the same size or different sizes. The heat shrink tube can be an easy-to-tear heat shrink tube and a non-tear heat shrink tube, preferably a non-tear heat shrink tube, and the material of the heat shrink tube can be polyolefin material, fluorine material, polyethylene material and the like.

[0042] The equipment provided by the present invention is suitable for the integrated molding of composite catheter tube bodies of the above-mentioned various structures and materials. It has strong universality and effectively solves the technical problem that catheter tube bodies of different structures and materials need to be separately configured with molding equipment, which can reduce equipment costs and improve production efficiency.

[0043] The specific implementation method of integrally molding a medical composite catheter body using the equipment and method provided by the present invention is as follows.

[0044] Example 1 Microcatheter body molding Step 1: Prepare the liner core, which can be of variable diameter and made of coated stainless steel.

[0045] Step 2: Prepare the inner layer and put the separate inner layer on the liner core. The material of the inner layer is polytetrafluoroethylene.

[0046] Step 3: Prepare the metal layer. The metal layer is a two-layer structure. The structure is that the entire catheter body is a braided structure and a spring structure. The braided structure is woven by a braiding machine, and the spring structure is made by a spring winding machine.

[0047] Step 4: Put on the outer tube. Put the outer tube on the metal layer in step 3. The outer tube has multiple sections with different hardness and different sizes.

[0048] Step 5: One-piece molding, put the non-tearable heat shrink tube sleeve and the outer layer of the outer tube in the one-piece molding equipment, and perform one-piece molding of the catheter tube body containing the liner core. The non-tearable heat shrink tube used is made of polyolefin. Due to the different hardness and size of the outer tube, two-stage temperature heating molding is adopted during composite molding. The composite temperature of the outer tube with a hardness of 45D-75D is 210℃, and the composite temperature of the outer tube with a hardness of 25D-45D is 190℃. The moving speed of the molding device is 1.0mm / s, and the speed of the winding motor is 1.0mm / s.

[0049] Step 6: Pull out the core, and pull out the variable diameter lining core to obtain the composite microcatheter tube body.

[0050] The pictures of the microcatheter tube body obtained in this embodiment before and after the composite molding process are as follows: Fig.12 As shown in the figure, it can be seen that the equipment and molding method provided by the present invention can be effectively applied to the integral molding of the microcatheter tube body.

[0051] Example 2 Forming of the outer tube body of the biliary stent Step 1: Provide a liner core, which may be non-variable and made of stainless steel.

[0052] Step 2: Prepare the inner layer and put the separate inner layer on the liner core. The material of the inner layer is polytetrafluoroethylene.

[0053] Step 3: Prepare the metal layer, which is a layer structure and a separate woven structure. The woven structure is woven by a woven machine.

[0054] Step 4: Put on the outer tube. Put the outer tube on the metal layer in step 3. The outer tube has the same hardness and size.

[0055] Step 5: One-piece molding: Put the non-tearable heat shrink tube sleeve and the outer layer of the outer tube into the one-piece molding equipment to perform one-piece molding of the catheter body containing the liner core. The non-tearable heat shrink tube used is made of fluorine material. The composite temperature is 220℃, the moving speed of the molding device is 1.2mm / s, and the speed of the winding motor is 1.2mm / s.

[0056] Step 6: Pull out the core and remove the lining core to obtain the composite biliary stent outer tube body.

[0057] The pictures of the bile duct stent outer tube body obtained in this embodiment before and after the composite molding process are as follows: Fig.13 As shown in the figure, it can be seen that the equipment and molding method provided by the present invention can be effectively applied to the one-piece molding of the outer sleeve tube body of the biliary stent.

[0058] Example 3: Forming of angiographic catheter body Step 1: Provide a lining core, which may be non-variable and made of polyoxymethylene.

[0059] Step 2: Prepare the inner layer, which can be extruded on the liner core. The inner layer material is Pebax 6333.

[0060] Step 3: Prepare the metal layer, which is a layer structure and a separate woven structure. The woven structure is woven by a woven machine.

[0061] Step 4: Put on the outer tube. Put the outer tube on the metal layer in step 3. The outer tube has the same hardness and size.

[0062] Step 5: One-piece molding: put the non-tearable heat shrink tube sleeve and the outer layer of the outer tube into the one-piece molding equipment to perform one-piece molding of the catheter body containing the liner core. The non-tearable heat shrink tube used is made of fluorine material. The composite temperature is 190℃, the moving speed of the molding device is 0.8mm / s, and the speed of the winding motor is 0.8mm / s.

[0063] Step 6: Pull out the core and remove the liner to obtain a composite angiography catheter body.

[0064] The pictures of the angiographic catheter tube body obtained in this embodiment before and after the composite molding process are as follows: Fig.14 As shown in the figure, it can be seen that the equipment and molding method provided by the present invention can be effectively applied to the integral molding of angiography catheter tube body.

[0065] Example 4: Forming of the guide sheath body Step 1: Provide a core liner. The core liner may be non-diameter-variable and may be made of copper.

[0066] Step 2: Prepare the inner layer and put the separate inner layer on the liner core. The material of the inner layer is polytetrafluoroethylene.

[0067] Step 3: Prepare the metal layer, which is a layer structure and a separate spring structure. The spring structure is made by a spring winding machine.

[0068] Step 4: Put on the outer tube. Put the outer tube on the metal layer in step 3. The outer tube has the same hardness and size.

[0069] Step 5: One-piece molding: Put the non-tearable heat shrink tube sleeve and the outer layer of the outer tube into the one-piece molding equipment to perform one-piece molding of the catheter body containing the liner core. The non-tearable heat shrink tube used is made of polyethylene. The compounding temperature is 210℃, the moving speed of the molding device is 1.0mm / s, and the speed of the winding motor is 1.0mm / s.

[0070] Step 6: Pull out the core and extract the liner core to obtain a composite guide sheath body.

[0071] The pictures of the guide sheath tube body obtained in this embodiment before and after the composite molding process are as follows: Fig.15 As shown in the figure, it can be seen that the device and molding method provided by the present invention can be effectively applied to the one-piece molding of the guide sheath tube body.

[0072] Example 5 Forming of multi-layer composite anesthesia catheter tube body Step 1: Provide a liner core, which may be non-variable and made of polytetrafluoroethylene.

[0073] Step 2: Prepare the inner layer, which can be extruded on the liner core, and the material of the inner layer is polyurethane.

[0074] Step 3: Prepare the metal layer, which is a layer structure and a separate spring structure. The spring structure is made by a spring winding machine.

[0075] Step 4: Put on the outer tube. Put the outer tube on the metal layer in step 3. The outer tube has the same hardness and size.

[0076] Step 5: One-piece molding: Put the non-tearable heat shrink tube sleeve and the outer layer of the outer tube into the one-piece molding equipment to perform one-piece molding of the catheter body containing the liner core. The non-tearable heat shrink tube used is made of fluorine material. The composite temperature is 230℃, the moving speed of the molding device is 0.5mm / s, and the speed of the winding motor is 0.5mm / s.

[0077] Step 6: Pull out the core, pull out the lining core, and obtain a composite multi-layer composite anesthesia catheter tube body.

[0078] The pictures of the multi-layer composite anesthesia catheter tube body obtained in this embodiment before and after the composite molding process are as follows: Fig.16 As shown in the figure, it can be seen that the equipment and molding method provided by the present invention can be effectively applied to the one-piece molding of a multi-layer composite anesthesia catheter tube body.

[0079] Example 6: Forming of the guide catheter body Step 1: Provide a core liner. The core liner may be non-diameter-variable and may be made of copper.

[0080] Step 2: Prepare the inner layer. A separate inner layer is put on the liner core. The material of the inner layer is polytetrafluoroethylene.

[0081] Step 3: Prepare the metal layer, the far end adopts a four-layer structure, and the proximal end adopts a three-layer structure. The braided structure is braided by a braiding machine, and the spring structure is made by a spring winding machine.

[0082] Step 4: Put on the outer tube. Put the outer tube on the metal layer in step 3. The outer tube is made of multiple sections with different hardness and the same size.

[0083] Step 5: One-piece molding: Put the non-tearable heat shrink tube sleeve and the outer layer of the outer tube into the one-piece molding equipment to perform one-piece molding of the catheter body containing the liner core. The non-tearable heat shrink tube used is made of fluorine material. The composite temperature is 220℃, the moving speed of the molding device is 1.5mm / s, and the winding motor speed is 1.5mm / s.

[0084] Step 6: Pull out the core and remove the liner to obtain a composite guide tube body.

[0085] The pictures of the multilayer guide catheter body obtained in this embodiment before and after the composite molding process are as follows: Fig.17 As shown, it can be seen from the figure that the equipment and molding method provided by the present invention can be effectively applied to the integral molding of the guide catheter body.

[0086] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A medical composite catheter body integral molding device, comprising a frame (1) and an electrical box (4), characterized in that: The invention also comprises a forming device (2) and a transmission device (3); the forming device (2) comprises a hot air fixing plate (201), on which a forming processing module consisting of a hot air module (218) and a heat shrink tube stripping module is provided; the transmission device (3) comprises a fixing frame (301), on which a tube head end clamping module and a synchronous control module are installed; the tube head end clamping modules and the forming processing modules are of the same number and are arranged in pairs; the synchronous control module comprises a synchronous belt (313), on which a synchronous belt connecting block (314) is provided, and the forming device (2) is fixedly connected to the transmission device (3) via the synchronous belt connecting block (314).

2. The medical composite catheter body integral molding device according to claim 1, characterized in that: The hot air module (218) has a hollow heating cavity, which is used for forming the tube body; the heat shrink tube stripping module comprises a guide plate (216) and a guide sleeve (217) fixedly connected to the guide plate (216), and the guide sleeve (217) is provided with a through hole for placing the tube body.

3. The medical composite catheter body integral molding device according to claim 2, characterized in that: A winding motor (205) is provided on the guide plate (216); a transmission shaft of the winding motor (205) is connected to a driving rotating shaft (213) via a coupling (207); the driving rotating shaft (213) is fixedly connected to a driving winding gear (208) and a driving winding wheel (215), respectively; the driving winding gear (208), the driving winding wheel (215) and the driving rotating shaft (213) are respectively arranged in pairs with a driven winding gear (209), a driven winding wheel (214) and a driven rotating shaft (212).

4. The medical composite catheter body integral molding device according to claim 3, characterized in that: The hot air module (218), the guide plate (216) and the winding motor (205) are respectively fixedly connected to the hot air fixing plate (201).

5. The medical composite catheter body integral molding device according to claim 1, characterized in that: The tube head end clamping module comprises an air gripper fixing plate (307) fixedly connected to the fixing frame (301), a clamp switch (308), a cylinder (309) and a clamp (310); the clamp switch (308) is fixedly connected to the air gripper fixing plate (307) and is connected to the cylinder (309) via an air rope; the clamp (310) is composed of two tube body fixing plates and is fixedly connected to the cylinder (309); a gap for accommodating the tube head end is left between the tube body fixing plates.

6. The medical composite catheter tube body integral molding device according to claim 1, characterized in that: The synchronous control module further comprises a synchronous wheel (304) and a synchronous motor (306); the synchronous belt (313) is sleeved on the synchronous wheel (304); the synchronous motor (306) is fixedly connected to the fixing frame (301) via a motor fixing block (312), and the transmission shaft of the motor is connected to the synchronous belt shaft (303) via a coupling (305); the synchronous belt shaft (303) is fixedly connected to the bearing seat (311) via a bearing, the bearing seat (311) is fixedly connected to the fixing frame (301) via a bearing seat fixing block (302), and the synchronous wheel (304) and the synchronous belt shaft (303) are connected via a bolt interference fit.

7. The medical composite catheter body integral molding device according to claim 1, characterized in that: The head end of the synchronous belt (313) is connected to a synchronous belt connection block (314), and the tail end is connected to a counterweight plate (316); a sliding connection block fixing plate (202) and a sliding connection block (203) are provided behind the hot air fixing plate (201) of the molding device (2); the sliding connection block fixing plate (202) is fixedly connected to the hot air fixing plate (201), the sliding connection block (203) is fixedly connected to the sliding connection block fixing plate (202), and the sliding connection block (203) is fixedly connected to the synchronous belt connection block (314) in a buckled or plugged manner.

8. A method for integrally forming a medical composite catheter body, characterized in that: The steps include: S1, putting the inner layer of the tube body on the lining core, and then assembling the metal layer, the outer tube and the heat shrink tube in sequence to obtain the tube body with the lining core; S2, starting the medical composite catheter tube body integrated molding device according to any one of claims 1 to 7, turning on the synchronous motor (306), moving the molding device (2) to the position directly below the fixed frame (301) in the transmission device (3), so that the molding processing module and the tube head end clamping module correspond one to another in the upper and lower parts; S3, turning off the synchronous motor (306), tearing off the outermost layer of the heat shrink tube at the head end of the liner core tube body described in S1, and then passing it through the hot air module (218) and the guide sleeve (217) in sequence, and then clamping and fixing the part of the head end not covered with the heat shrink tube by the clamp (310), and winding the torn heat shrink tube at the head end onto the active winding wheel (215) and the driven winding wheel (214); S4, setting the composite temperature of the hot air module (218), the moving speed of the forming device (2), and the reeling speed of the reeling motor (205) through the electrical box (4); turning on the reeling motor (205) and the synchronous motor (306) at the same time, controlling the forming processing device (2) to move toward the lower end of the tube body containing the liner core, and the hot air module (218) heats and composites the inner layer, the metal layer, and the outer layer of the tube body containing the liner core, while the active reeling wheel (215) and the driven reeling wheel (214) reel in the peeled heat shrink tube; S5, taking out the tube body containing the liner core after the heat shrink tube is stripped off and removed in S4 from the medical composite catheter tube body integrally forming device, and extracting the liner core to obtain the integrally formed medical composite catheter tube body.

9. The method for integrally forming a medical composite catheter body according to claim 8, characterized in that: The composite temperature of the hot air module (218) in S4 is 170-250°C, the moving speed of the forming device (2) is 0.1-10 mm / s, and the winding speed of the winding motor (205) is 0.1-10.0 mm / s.

10. The method for integrally forming a medical composite catheter body according to claim 8, characterized in that: The medical composite catheter comprises a microcatheter, a biliary stent outer sleeve, an angiography catheter, a guide sheath, a multi-layer composite anesthesia catheter or a guide catheter.

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