CN111300704A

CN111300704A - Enhanced medical catheter and molding process thereof

Info

Publication number: CN111300704A
Application number: CN201811574234.1A
Authority: CN
Inventors: 孙立民; 袁栋平; 刘志军; 魏信鑫; 马奔
Original assignee: Dongguan Kewei Medical Instrument Co Ltd
Current assignee: Dongguan Kewei Medical Instrument Co Ltd
Priority date: 2018-12-21
Filing date: 2018-12-21
Publication date: 2020-06-19

Abstract

The invention discloses a reinforced medical catheter and a forming process thereof, wherein the forming process comprises the steps of firstly manufacturing a base layer pipe, then arranging a reinforcing rib in the base layer pipe, then injecting a first feed liquid into the base layer pipe, then uniformly attaching the first feed liquid in the base layer pipe to the inner wall of the base layer pipe in a mode of rotating the base layer pipe and covering the reinforcing rib, wherein the reinforcing rib does not displace in the rotating process, and finally plasticizing the first feed liquid in the base layer pipe under the state of keeping the base layer pipe rotating to form the reinforced medical catheter with the reinforcing rib.

Description

Enhanced medical catheter and molding process thereof

Technical Field

The invention relates to the field of enhanced medical catheters, in particular to an enhanced medical catheter and a molding process thereof.

Background

The common forming method adopted by the prior reinforced medical catheter is to firstly sleeve the spring on the manufactured basic tube body, then dip the basic tube body sleeved with the spring in feed liquid for manufacturing the reinforced medical catheter and repeatedly dip the basic tube body in the feed liquid for manufacturing the reinforced medical catheter. The enhanced medical catheter formed by repeated dipping has low processing efficiency, resulting in high cost; meanwhile, in the manufacturing process, the material liquid attached to the outer surface of the tube core flows downwards under the action of gravity, the wall of the finally formed enhanced medical catheter has the problem of uneven thickness, and the transition section is easy to have the problem of unsmooth inner wall when the diameter-variable enhanced medical catheter is formed by adopting the repeated plastic dipping method, so that the smooth flow of blood is not facilitated.

In addition, when the catheter to be formed is of a long size (for example, a femoral vein cannula having a length greater than 300 mm), the spring for reinforcing and supporting the tube is slender, and the spring is easily deformed and/or displaced during repeated dipping, so that the tube of the final formed product has different strength and quality, and the defect may be bent or collapsed during the operation; meanwhile, the length of the conduit to be molded is long, and the wall thickness of the conduit to be molded is thin, so that the molded conduit is attached to the tube core, the friction with the tube core is too large, and the conduit cannot be demolded from the tube core basically, and the molding is difficult.

Disclosure of Invention

The embodiment of the invention provides a reinforced medical catheter and a forming process thereof, which aim to solve the problems of low forming efficiency, uneven wall thickness of a catheter body, difficulty in demolding and the like caused by the fact that a forming method adopted by the existing reinforced medical catheter needs repeated dipping.

In order to solve the technical problem, the invention provides a molding process of an enhanced medical catheter, which comprises the following steps: providing a substrate tube; arranging a reinforcing rib in the base layer pipe; injecting a first feed liquid into the base layer pipe; rotating the base layer pipe filled with the first feed liquid, wherein the first feed liquid is uniformly distributed on the inner wall of the base layer pipe and covers the reinforcing ribs; the first feed liquid within the rotating base layer tube is plasticized to form the reinforced medical catheter.

According to an embodiment of the present invention, the step of providing the substrate tube includes manufacturing the substrate tube by using a catheter extruder.

According to an embodiment of the present invention, the step of rotating the substrate tube filled with the feed liquid includes rotating the forming mold by placing the substrate tube filled with the first feed liquid in the forming mold, and the forming mold drives the substrate tube to rotate.

According to an embodiment of the present invention, in the step of providing a base pipe, the step of manufacturing the base pipe includes: providing a forming die, wherein the forming die is provided with a tubular inner cavity; injecting a second feed liquid into the tubular inner cavity of the forming die; rotating the forming die filled with the feed liquid to uniformly distribute the second feed liquid on the inner wall of the forming die; the second liquid in the rotating forming die is plasticized to form a substrate tube.

According to an embodiment of the present invention, before the step of injecting the second material liquid into the forming mold, preheating the second material liquid is further included.

According to an embodiment of the present invention, the step of plasticizing the second liquid in the molding die includes heating the rotating molding die to make the temperature of the second liquid in the molding die reach the molding temperature, thereby plasticizing the second liquid.

According to an embodiment of the present invention, the step of plasticizing the first material liquid in the rotating base layer tube includes heating the rotating forming die to make the temperature of the first material liquid in the base layer tube reach the molding temperature, thereby plasticizing the first material liquid.

According to an embodiment of the present invention, before the step of rotating the base layer tube filled with the first material liquid, the step of preheating the forming mold to plasticize the first material liquid further includes cooling and shaping the plasticized first material liquid to form the reinforced medical catheter.

According to one embodiment of the present invention, the step of injecting the first feed liquid into the base layer tube is preceded by preheating the first feed liquid.

The invention provides a reinforced medical catheter which is formed by using the forming process.

In the embodiment of the invention, the reinforced medical catheter is formed by tightly attaching the reinforcing ribs to the inner wall of the base layer pipe, injecting the first material liquid into the base layer pipe, enabling the reinforcing ribs not to displace in the process of rotating the base layer pipe, enabling the first material liquid to be uniformly attached to the inner wall of the base layer pipe and cover the reinforcing ribs, and finally plasticizing the first material liquid in the base layer pipe under the condition of keeping the base layer pipe rotating.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiment(s) of the invention and together with the description serve to explain the invention without limiting the invention. In the drawings:

FIG. 1 is a schematic step view of a process for forming a reinforced medical catheter in accordance with a first embodiment of the present invention;

FIG. 2 is a schematic view of a substrate tube according to a first embodiment of the present invention;

FIG. 3 is a schematic view of a reinforcing bar incorporated into a base pipe according to a first embodiment of the present invention;

FIG. 4 is a schematic view of the first embodiment of the present invention with the base pipe installed in the forming mold;

FIG. 5 is a schematic view of a reinforced medical catheter in accordance with a first embodiment of the present invention;

FIG. 6 is a schematic view of a reinforced medical catheter molding die of a first embodiment of the present invention;

FIG. 7 is a schematic view of a molding apparatus according to a first embodiment of the present invention;

FIG. 8 is a sectional view of the molding apparatus of the first embodiment of the present invention;

FIG. 9 is an enlarged view of area A of FIG. 8;

FIG. 10 is another sectional view of the molding apparatus of the first embodiment of the present invention;

FIG. 11 is a schematic illustration of the steps of a second embodiment base pipe forming process of the present invention;

FIG. 12 is a schematic view of a second embodiment of the present invention showing the substrate tube being cooled and set in a forming mold;

FIG. 13 is a schematic view of a second embodiment of the reinforcing bar of the present invention disposed within a base pipe;

fig. 14 is a sectional view of a molding die of a third embodiment of the invention;

FIG. 15 is a schematic view of a molding apparatus according to a third embodiment of the present invention;

fig. 16 is a sectional view of a molding apparatus according to a third embodiment of the present invention;

fig. 17 is an enlarged view of the region B of fig. 16.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are one embodiment of the present invention, and not all embodiments of the present invention. All other embodiments obtained by a person skilled in the art based on the embodiments of the present invention without any creative work belong to the protection scope of the present invention.

Please refer to fig. 1, fig. 2, fig. 3, fig. 4 and fig. 5, which are a schematic diagram of a step of a molding process of a reinforced medical catheter, a schematic diagram of a base tube, a schematic diagram of a reinforcing rib installed in the base tube, a schematic diagram of a base tube installed in a molding mold, and a schematic diagram of a reinforced medical catheter according to a first embodiment of the present invention, respectively. As shown in the figure, the reinforced medical catheter forming process of the present embodiment is to perform step S11 to manufacture the base layer tube 10, in the present embodiment, the base layer tube 10 is extruded by a catheter extruder, the base layer tube 10 extruded by the catheter extruder may be in the form of a straight tube, a tapered tube or a special-shaped tube, the base layer tube 10 in the present embodiment is a straight tube (as shown in fig. 2), and the catheter extruder used for extruding the base layer tube 10 may be a single screw extruder, a twin screw extruder or other extruders capable of extruding catheters.

Step S13 is executed again, where the ribs 11 are provided in the base layer pipe 10, the ribs 11 are closely attached to the inner wall of the base layer pipe 10 (as shown in fig. 3), the shape of the ribs 11 corresponds to the shape of the inner wall of the base layer pipe 10, in this embodiment, the base layer pipe 10 is a straight pipe, and the outer diameter of the ribs 11 is uniform, that is, the outer wall shape of the ribs 11 corresponds to the shape of the inner wall of the base layer pipe 10. Specifically, the reinforcing beads 11 of the present embodiment are springs having an outer diameter greater than or equal to the inner diameter of the base pipe 10, so that the reinforcing beads 11 can be embedded or attached to the inner wall of the base pipe 10 to fix the reinforcing beads 11 to the inner wall of the base pipe 10.

Next, step S15 is executed to inject a first liquid into the base layer tube 10, wherein the amount of the first liquid injected into the base layer tube 10 is determined according to the wall thickness of the reinforced medical catheter 1 to be manufactured, and the material of the first liquid may be any one of PVC (polyvinyl chloride) emulsion, TPU (polyurethane) emulsion, and other medical materials or a blend emulsion thereof that can be used to manufacture the reinforced medical catheter 1 and that meets the biocompatibility.

Then, step S17 is executed to rotate the base layer tube 10 filled with the first feed liquid, so that the first feed liquid is uniformly distributed on the inner wall of the base layer tube 10 and covers the reinforcing ribs 11, in this embodiment, the base layer tube 10 filled with the reinforcing ribs 11 and the first feed liquid is rotated by placing the base layer tube 10 filled with the reinforcing ribs 11 and the first feed liquid in the forming mold 2 (as shown in fig. 4), and rotating the forming mold 2 to drive the base layer tube 10 to rotate. Specifically, the rotation speed of the forming mold 2 is 50 to 350rad/min, the forming mold 2 has a tubular inner cavity, and the shape of the base layer tube 10 corresponds to the shape of the tubular inner cavity of the forming mold 2, so that the base layer tube 10 can be tightly attached to the inner wall of the forming mold 2 when being placed in the forming mold 2, and the forming mold 2 drives the base layer tube 10 to synchronously rotate.

Finally, step S19 is performed to plasticize the first liquid inside the rotating base layer tube 10 to form the reinforced medical catheter 1 of the present embodiment. Specifically, forming die 2 drives base layer pipe 10 to rotate, and after first feed liquid in base layer pipe 10 uniformly adheres to the inner wall of base layer pipe 10 through rotation and covers reinforcing rib 11, rotating forming die 2 starts to be heated, so that the temperature of first feed liquid in base layer pipe 10 rises. When the temperature of the first liquid reaches the molding temperature of the first liquid, the first liquid attached to the inner wall of the base layer tube 10 is gradually plasticized, and the first liquid covering the reinforcing ribs 11 is fused with the base layer tube 10 in the plasticizing process to form the hollow conduit which covers the reinforcing ribs 11 and has the same tube wall thickness. Cooling and shaping the hollow catheter to form the reinforced medical catheter 1 in the forming die 2, and opening the forming die 2 to obtain the reinforced medical catheter 1 (shown in figure 5). The heating temperature of the forming mold 2 is between 120 ℃ and 170 ℃, and the heating temperature can be adaptively adjusted according to the molding temperature of the first material liquid, so that the first material liquid in the base layer tube 10 is fully plasticized, and the enhanced medical catheter 1 of the embodiment is formed.

In step S13, since the outer diameter of the bead 11 is greater than or equal to the outer diameter of the base pipe 10, the inner diameter of the base pipe 10 may be enlarged before the bead 11 is installed in the base pipe 10, so that the bead 11 is completely inserted into the base pipe 10. The inner diameter of the base pipe 10 may be enlarged by extruding the base pipe 10 or expanding the base pipe 10 by inflating the base pipe 10 to enlarge the inner diameter of the base pipe 10 such that the inner diameter of the base pipe 10 is larger than the outer diameter of the reinforcing beads 11, so that the reinforcing beads 11 are completely inserted into the base pipe 10.

In the process of forming the reinforced medical catheter 1 according to the present embodiment, before the step S15 of injecting the first material liquid into the base layer tube 10, the first material liquid may be preheated and then injected into the base layer tube 10, the preheated first material liquid has good fluidity, and the preheated first material liquid can be more rapidly attached to the inner wall of the base layer tube 10 during the step S17 of rotating the base layer tube 10 filled with the first material liquid, so as to shorten the time of performing the step S17.

Or, while step S17 is executed, the forming mold 2 may be preheated to increase the temperature of the first material liquid in the base layer tube 10, so as to improve the flowability of the first material liquid, and also accelerate the first material liquid to uniformly adhere to the inner wall of the base layer tube 10, and at the same time, the temperature of the first material liquid in the base layer tube 10 may reach the molding temperature thereof more quickly, so as to accelerate the plasticizing efficiency, so as to shorten the forming time of the enhanced medical catheter 1 of the present embodiment, and improve the forming efficiency of the formed enhanced medical catheter 1.

In this embodiment, step S17 is executed first, and then step S19 is executed, in other words, the forming mold 2 equipped with the base layer tube 10 is rotated first, the forming mold 2 drives the base layer tube 10 to rotate, so that the first material liquid in the base layer tube 10 is attached to the inner wall of the base layer tube 10 and covers the reinforcing rib 11, and then the forming mold 2 is heated, so that the first material liquid in the base layer tube 10 is plasticized by heat, during the plasticizing process, the forming mold 2 continues to drive the base layer tube 10 to rotate, so that the first material liquid in the base layer tube 10 is fully plasticized, so as to form the enhanced medical catheter 1 of this embodiment, wherein the pre-rotating time is controlled between 1min and 3min, and the plasticizing time of the forming mold 2 is between 3min and 7 min.

Referring to fig. 2 and fig. 3 again, as shown in the figures, the base layer tube 10 of the present embodiment further includes two pipe orifice end enclosures 101 matching with the openings at the two ends of the base layer tube 10, in the present embodiment, the pipe orifice end enclosures 101 are plug bodies, or certainly, cover bodies, and the two pipe orifice end enclosures 101 are plugged into the openings at the two ends of the base layer tube 10 to prevent the first material liquid from flowing out of the base layer tube 10. Specifically, before the step S15 is executed to inject the first feed liquid into the base layer tube 10, one tube mouth sealing head 101 is plugged into the opening at one end of the base layer tube 10, then the first feed liquid is injected into the base layer tube 10 from the opening at the other end, and after the first feed liquid is completely injected into the base layer tube 10, the other tube mouth sealing head 101 is plugged into the opening at the other end of the base layer tube 10, so that the base layer tube 10 with the reinforcing ribs 11 and the first feed liquid is placed in the forming mold 1, and then the steps S17 and S19 are continuously executed, so that the first feed liquid can be prevented from flowing out of the base layer tube 10.

Referring to fig. 4 and 6 together, fig. 6 is a schematic view of an enhanced medical catheter forming mold according to a first embodiment of the invention. As shown in the figure, the forming mold 2 of the present embodiment is a straight tube type corresponding to the shape of the base tube 10, the tubular inner cavity of the forming mold 2 is a straight tube, and the length of the tubular inner cavity of the forming mold 2 corresponds to the length of the base tube 10, in other words, as the length of the reinforced medical catheter 1 to be formed is longer, the length of the forming mold 2 is increased, and as the length of the forming mold 2 is increased, the rigidity of the forming mold 2 is increased, thereby preventing the reinforced medical catheter 1 from being deformed due to the deformation of the forming mold 2 during the manufacturing process. Specifically, the forming mold 2 of the present embodiment includes a first body 21 and a second body 22, the first body 21 and the second body 22 respectively have a first space 211 and a second space 221, and before performing step S17, the first body 21 and the second body 22 are assembled, so that the first space 211 and the second space 221 form a tubular inner cavity of the forming mold 2 of the present embodiment.

In this embodiment, at least one end of the assembled forming mold 2 is provided with a mold vent 23, correspondingly, at least one pipe orifice end enclosure 101 of the base pipe 10 is provided with an end enclosure vent 1011, when the base pipe 10 is placed in the forming mold 2, the end provided with the end enclosure vent 1011 corresponds to the end of the forming mold 2 provided with the mold vent 23, and the end enclosure vent 1011 is communicated with the mold vent 23, so that the tubular inner cavity of the base pipe 10 is communicated with the outside. When step S17 is executed, the forming mold 2 is heated, and the gas in the base layer tube 10 expands due to heating, so that the gas pressure in the base layer tube 10 rises, and the gas in the base layer tube 10 can be exhausted out of the base layer tube 10 through the head vent 1011 and the mold vent 23, so as to balance the gas pressure in the base layer tube 10, and similarly, in the process of cooling and forming the hollow catheter, the gas pressure in the base layer tube 10 will drop, and the gas pressure inside and outside the base layer tube 10 can be balanced by the head vent 1011 and the mold vent 23, so as to prevent the formed reinforced medical catheter 1 from being deformed due to the change of the gas pressure, or prevent the atmospheric pressure from being higher than the gas pressure in the forming mold 2 after the hollow catheter is cooled and formed, so that when the reinforced medical catheter 1 formed in the forming mold 2 is taken out, the first body 21 and the second body 22 which are connected to each other can be opened quickly.

In this embodiment, steps S17 and S19 of the reinforced medical catheter molding process of this embodiment are executed to mainly set the molding die 2 on the molding device 3 for rotation and heating, and the structure of the molding device 3 will be described in detail below, with reference to fig. 7, 8, 9 and 10, which are a schematic view, a cross-sectional view and an enlarged view of the area a of fig. 8 of the molding device of the first embodiment of the present invention. As shown in the figure, in the present embodiment, the molding apparatus 3 includes a clamping mechanism 30, a driving mechanism 31 and a heating device 32, the clamping mechanism 30 has a clamping driving shaft 301 and a clamping linkage shaft 302 opposite to the clamping driving shaft 301, and the driving mechanism 31 is disposed on one side of the clamping mechanism 30 and connected to the clamping driving shaft 301. The heating device 32 is disposed below the clamping mechanism 30, and the extending direction of the heating device 32 is parallel to the line connecting the axial center of the clamping driving shaft 301 and the axial center of the clamping interlinking shaft 302. When the molding die 2 is clamped by the clamping driving shaft 301 and the clamping interlocking shaft 302, the axis of the molding die 2 and the connecting line of the axis of the clamping driving shaft 301 and the axis of the clamping interlocking shaft 302 are located on the same line, the heating device 32 is located right below the connecting line of the axis of the clamping driving shaft 301 and the axis of the clamping interlocking shaft 302, and the molding die 2 is closest to the heating device 32. The driving mechanism 31 drives the clamping driving shaft 301 to rotate, the clamping driving shaft 301 drives the forming mold 2 to rotate by taking the axis as the center line, and the clamping linkage shaft 302 rotates along with the rotation of the forming mold 2.

The clamping mechanism 30 further comprises a base plate 303, a fixed seat 304 and a movable seat 305, wherein the fixed seat 304 is disposed on the base plate 303, and the movable seat 305 is movably connected to the base plate 303 and moves relative to the fixed seat 304. The clamping driving shaft 301 is pivotally connected to the fixed base 304, and the clamping linking shaft 302 is pivotally connected to the movable base 305, and a connection line between the axis of the clamping driving shaft 301 and the axis of the clamping driving shaft extends along the length direction of the bottom plate 303 and is parallel to the bottom plate 303. Specifically, two opposite sliding grooves 3031 are disposed on the bottom plate 303 of the embodiment, the extending direction of the two sliding grooves 3031 and a connecting line between the axis of the clamping driving shaft 301 and the axis of the clamping linkage shaft 302 are parallel to each other, and the movable seat 305 is movably connected to the two sliding grooves 3031 to move along the two sliding grooves 3031 relative to the fixed seat 304, so that the distance between the clamping driving shaft 301 and the clamping linkage shaft 302 can be adjusted according to the length of the molding die 2.

The movable base 305 further includes two guide members 3051, and in this embodiment, the two guide members 3051 are slidably disposed in the sliding grooves 3031, respectively. Specifically, the chute 3031 of the present embodiment has a reverse T shape, the guide 3051 has a corresponding reverse T shape, and a gap is provided between the guide 3051 and the wall of the chute 3031, so that the guide 3051 can slide relative to the chute 3031.

The movable seat 305 further has two locking members 3052, in this embodiment, the number of the locking members 3052 is two, and the two locking members 3052 are respectively located at two sides of the two sliding grooves 3031, which are relatively far away from each other. Specifically, retaining member 3052 of this embodiment is locking screw, every locking screw corresponds bottom plate 303 and sets up, retaining member 3052 is screwed up, the clearance between the cell wall of guide 3051 and spout 3031 reduces gradually, when retaining member 3052 and guide 3051 centre gripping bottom plate 303, sliding seat 305 locks in bottom plate 303, the distance between fixing base 304 and sliding seat 305 is fixed, loosen retaining member 3052, adjust the distance between fixing base 304 and the sliding seat 305, forming device 3 of this embodiment can be used for the enhancement mode medical catheter 1 of the different length of shaping.

The fixing base 304 has a fixing shaft hole, and the clamping driving shaft 301 passes through the fixing shaft hole of the fixing base 304. Similarly, the movable base 305 has a movable shaft hole, and the clamping coupling shaft 302 is disposed through the movable shaft hole of the movable base 305. Bearings 306 are arranged between the fixed shaft hole and the clamping driving shaft 301 and between the movable shaft hole and the clamping linkage shaft 302, and the bearings 306 can enable the clamping driving shaft 301 and the clamping linkage shaft 302 to smoothly rotate in the fixed shaft hole and the movable shaft hole respectively.

The end of the clamping driving shaft 301 facing the clamping linkage shaft 302 is provided with a fixing clamping groove 3011, the cross-sectional shape of the end of the forming die 2 connected to the clamping driving shaft 301 matches with the cross-sectional shape of the fixing clamping groove 3011, so that the end of the forming die 2 is fixed on the clamping driving shaft 301 by being connected with the fixing clamping groove 3011, and the clamping driving shaft 301 drives the forming die 2 to rotate.

The clamping linkage shaft 302 includes a rotation shaft portion 3021, a clamping shaft portion 3022, and an elastic member 3023, the clamping shaft portion 3022 is disposed through the rotation shaft portion 3021, and the elastic member 3023 is disposed between the clamping shaft portion 3022 and the rotation shaft portion 3021. The clamp shaft portion 3022 is movable relative to the rotary shaft portion 3021 to compress the elastic member 3023 and increase the distance between the clamp shaft portion 3022 and the clamp driving shaft 301, thereby facilitating the placement of the molding die 2. The end of the clamping shaft portion 3022 facing the clamping driving shaft 301 is provided with a linkage clamping groove 30221, the end of the forming die 2 close to the clamping linkage shaft 302 is connected with the linkage clamping groove 30221, the cross-sectional shape of the linkage clamping groove 30221 matches with the cross-sectional shape of the end of the forming die 2 close to the clamping linkage shaft 302, so that the end of the forming die 2 close to the clamping linkage shaft 302 is fixed on the clamping linkage shaft 302 by being connected with the linkage clamping groove 30221, and the forming die 2 driven by the clamping driving shaft 301 drives the clamping linkage shaft 302 to rotate.

The rotation shaft portion 3021 has an accommodating groove 30211 at an end facing the clamp driving shaft 301, the elastic member 3023 is disposed in the accommodating groove 30211, the clamp shaft portion 3022 passes through the elastic member 3023 and the rotation shaft portion 3021, and an end of the clamp shaft portion 3022 having the interlocking engaging groove 30221 is located in the accommodating groove 30211, so that the accommodating groove 30211 can limit the position of the elastic member 3023, and the elastic member 3023 can be located between the rotation shaft portion 3021 and the clamp shaft portion 3022. The clamping linkage shaft 302 further comprises a handle 3024, the handle 3024 is connected with one end of the clamping shaft portion 3022, which is far away from the clamping drive shaft 301, when the clamping linkage shaft 302 is used, the clamping shaft portion 3022 is pulled by the handle 3024 to move in a direction far away from the clamping drive shaft 301, so that the distance between the clamping shaft portion 3022 and the clamping drive shaft 301 is increased, the forming die 2 is easy to place between the clamping drive shaft 301 and the clamping linkage shaft 302, and the forming die 2 is also convenient to take out from between the clamping drive shaft 301 and the clamping linkage shaft 302.

When the clamping driving shaft 301 and the clamping linkage shaft 302 clamp the forming mold 2, the forming mold 2 is parallel to a workbench on which the forming device 3 is placed, in step S17 and step S19, the driving mechanism 31 drives the forming mold 2 to drive the base layer tube 10 to rotate, the reinforcing ribs 11 rotate synchronously with the base layer tube 10 around the axis of the forming mold 2, in the rotating process, the relative positions of the reinforcing ribs 11 and the base layer tube 10 can be kept unchanged, and the strength of the tube body of the finally cooled and shaped enhanced medical catheter 1 is uniform.

The driving mechanism 31 is disposed on the bottom plate 303 and is located at one side of the fixing base 304. The driving mechanism 31 includes a driver 311 and a driving controller 312, the driving controller 312 is electrically connected to the driver 311, and the driver 311 is connected to the clamping driving shaft 301 to drive the clamping driving shaft 301 to rotate. In this embodiment, the driver 311 is a motor, and the driving controller 312 is used to control the start and stop of the motor and adjust the rotation speed of the motor. The driving mechanism 31 further includes a transmission structure 313, and the transmission structure 313 is respectively connected to the driver 311 and the clamping driving shaft 301, in this embodiment, the transmission structure 313 is a transmission belt, but the transmission structure 313 may also be a gear or other transmission structures.

The heating device 32 includes a heating pipe 321 and a temperature controller 322 electrically connected to the heating pipe 321, wherein the heating pipe 321 is disposed on the bottom plate 303, one end of the heating pipe 321 penetrates through the movable seat 305, and the temperature controller 322 is configured to control opening and closing of the heating pipe 321, or adjust a heating temperature of the heating pipe 321, so that the forming apparatus 3 of the present embodiment can adjust the heating temperature according to a molding temperature of the first material liquid during forming the enhanced medical catheter 1. In the present embodiment, the heating pipe 321 is an infrared heating pipe, but may be an electromagnetic heating pipe or other heating pipes.

The molding apparatus 3 of the present embodiment further includes a warming cover 33, and one end of the warming cover 33 is pivotally connected to the base plate 303 and located on one side of the chucking mechanism 30. When the driving mechanism 31 drives the forming mold 2 to rotate through the clamping mechanism 30 and the heating device 32 heats the forming mold 2, the temperature-rising cover 33 rotates relative to the bottom plate 303 to cover the clamping mechanism 30, the inner wall of the temperature-rising cover 33 abuts against the partition plates 307 of the fixed seat 304 and the movable seat 305, so that the forming mold 2 arranged on the clamping mechanism 30 is located in a heating space formed by the temperature-rising cover 33, the two partition plates 307 and the bottom plate 303, and heat energy generated by the heating device 32 is uniformly distributed in the heating space to uniformly heat the forming mold 2.

In the present embodiment, the plurality of auxiliary heating devices 34 are further disposed on the inner wall of the temperature-increasing cover 33 at intervals, in the present embodiment, the auxiliary heating devices 34 are infrared heating pipes, the plurality of auxiliary heating devices 34 are respectively electrically connected to the temperature controller 322, and the temperature controller 322 controls the plurality of auxiliary heating devices 34 to be turned on and off, or adjusts the heating temperature. The extending direction of each auxiliary heating device 34 is parallel to the connecting line of the axis of the clamping driving shaft 301 and the axis of the clamping linkage shaft 302, the heating device 32 heats the lower part of the forming mold 2, and the plurality of auxiliary heating devices 34 heat the upper part of the forming mold 2, so that the forming mold 2 is heated uniformly. In the present embodiment, the temperature rising lid 33 is an arc lid, the number of the auxiliary heating devices 34 is two, and the distances from each of the auxiliary heating devices 34 to the molding die 2 from the heating device 32 are equal to each other, so that the heating intensity of the molding die 2 by the heating device 32 and each of the auxiliary heating devices 34 is the same. In addition, the heating device 32 and each auxiliary heating device 34 are equally spaced around the forming mold 2, so that the forming mold 2 is uniformly heated.

Therefore, the reinforced medical catheter 1 forming process can continuously form the reinforced medical catheter 1 in a one-step forming mode through the forming equipment 3 and the plurality of forming dies 2, is simple to operate, quick to demould and high in forming efficiency, the tubular inner cavity space of the forming dies 2 is independent, impurity infiltration is reduced, product quality is improved, the first material liquid in the forming dies 2 is gradually heated and plasticized in a natural flowing state, the inner wall of the cooled and shaped reinforced medical catheter 1 is not in contact with the forming dies 2 in the forming process, and therefore the inner wall smoothness of the reinforced medical catheter 1 is high, and blood can flow in the reinforced medical catheter 1 more smoothly.

Please refer to fig. 11, 12 and 13, which are schematic diagrams illustrating a step of a method for forming a base layer tube, a schematic diagram illustrating the base layer tube being cooled and shaped in a forming mold, and a schematic diagram illustrating reinforcing ribs being disposed in the base layer tube according to a second embodiment of the present invention. In the molding process of the reinforced medical catheter of the present embodiment, step S11 is still performed first to manufacture the base layer tube 10, the base layer tube 10 of the present embodiment is manufactured by the following molding method, as shown in fig. 11, the molding method of the base layer tube 10 of the present embodiment is to perform step S110 first to provide the molding die 2, and the molding die 2 has a tubular inner cavity; then, step S112 is executed to inject a second material liquid into the tubular cavity of the forming mold 2; step S114 is executed again, the forming die 2 filled with the second material liquid is rotated, and the second material liquid is uniformly distributed on the inner wall of the forming die 2; finally, step S116 is performed to plasticize the second material liquid in the rotating forming die 2 to form the substrate tube 10. The shape of the formed base pipe layer 10 corresponds to the shape of the tubular cavity of the forming mold 2, the shape of the tubular cavity of the forming mold 2 may be a straight pipe shape, a reducing pipe shape or other shapes, the shape of the corresponding base pipe layer 10 is a straight pipe shape, a reducing pipe shape, a special pipe shape or other shapes, the shape of the tubular cavity of the forming mold 2 in the present embodiment is a straight pipe shape, and the formed base pipe layer 10 is a straight pipe.

In the step S112 of injecting the second liquid into the tubular inner cavity of the forming mold 2, the amount of the second liquid injected into the forming mold 2 is determined according to the wall thickness of the base layer tube 10 to be manufactured, and the second liquid may be any one or more of PVC (polyvinyl chloride) emulsion, TPU (polyurethane) emulsion, and other medical materials that can be used for manufacturing the enhanced medical catheter 1 and meet the biocompatibility.

In the step S114 of rotating the forming mold 2 filled with the second liquid, the second liquid in the forming mold 2 is gradually and uniformly distributed on the inner wall of the forming mold 2 in a natural flow by the rotating centrifugal force, wherein the rotating speed of the forming mold 2 is between 50 to 350rad/min, and the rotating time of the forming mold 2 lasts for 1 to 3 min.

Specifically, in the step S116 of plasticizing the second liquid inside the rotating forming die 2, after the second liquid inside the forming die 2 is uniformly adhered to the inner wall of the forming die 2 by rotation, the rotating forming die 2 starts to be heated, and when the temperature of the heated second liquid reaches the molding temperature of the second liquid, the second liquid adhered to the inner wall of the forming die 2 is gradually plasticized, so that the hollow conduit with a uniform wall thickness is formed inside the forming die 2. The hollow conduit is cooled and shaped to form the base pipe 10 in the forming die 2. In the present embodiment, the heating temperature of the forming mold 2 is between 120 ℃ and 170 ℃, and the heating time of the forming mold 2 is between 3min and 7min, wherein the heating temperature and the heating time can be adaptively adjusted according to the molding temperature of the second material liquid, so that the second material liquid in the forming mold 2 is fully plasticized to form the base layer tube 10 of the present embodiment.

When the base layer pipe 10 is manufactured by the base layer pipe forming method according to the present embodiment, the second material liquid may be preheated before the step S112 is performed, and then the second material liquid is injected into the forming mold 2, and the preheated second material liquid has good fluidity, and the preheated second material liquid can be more rapidly attached to the inner wall of the forming mold 2 in the process of rotating the forming mold 2 filled with the second material liquid in the step S114, thereby shortening the time for performing the step S114. Or, in the process of executing step S114 to rotate the forming mold 2 filled with the second liquid, the forming mold 2 may be preheated at the same time, so that the second liquid in the forming mold 2 is heated while being gradually and uniformly attached to the inner wall of the forming mold, thereby achieving the effect of insulating the second liquid or increasing the temperature of the second liquid, when the temperature of the second liquid in the forming mold 2 is increased, the second liquid is also accelerated to be attached to the inner wall of the forming mold 2, and at the same time, the temperature of the second liquid in the forming mold 2 is also increased faster to reach the molding temperature thereof by insulating the second liquid or increasing the temperature of the second liquid first, thereby increasing the efficiency of plasticizing the second liquid, shortening the time consumed by the forming process of the enhanced medical catheter of the present embodiment, and improving the forming efficiency of the formed enhanced medical catheter 1.

In the first embodiment, after the execution of step S11 is completed, the process for molding a reinforced medical catheter according to this embodiment is continued to step S13. Specifically, after the base layer tube 10 is cooled and shaped in the forming mold 2, the reinforcing ribs 11 are placed in the base layer tube 10 in the forming mold 2 (as shown in fig. 13), and in this embodiment, the reinforcing ribs 11 are springs having an outer diameter equal to the inner diameter of the base layer tube 10.

Then, step S15, step S17 and step S19 are performed, step S15, step S17 and step S19 of this embodiment are the same as step S15, step S17 and step S19 of the first embodiment, wherein step S17 and step S19 are completed by using the molding apparatus of the first embodiment, which is not described herein again, but before step S15 is performed, the first material liquid may be preheated, and before step S19 is performed, the molding mold 2 may be preheated, so as to further shorten the time consumption of the molding process of the reinforced medical catheter of this embodiment, and further improve the molding efficiency of the reinforced medical catheter 1.

Please refer to fig. 14, which is a sectional view of a forming mold according to a second embodiment of the present invention. As shown in the figures, the forming mold 2 of the present embodiment further includes at least one mold end enclosure 24, at least one end of the assembled first body 21 and second body 22 is provided with a glue injection port 25, the shape of the mold end enclosure 24 corresponds to the shape of the glue injection port 25, the mold end enclosure 24 of the present embodiment is a plug body, the mold end enclosure 24 can be plugged into the glue injection port 25, and the first feed liquid or the second feed liquid is prevented from flowing out of the forming mold 2.

When the second material liquid is injected into the tubular inner cavity of the forming mold 2 in step S112 or the first material liquid is injected into the base layer pipe 10 in step S15, the first material liquid or the second material liquid is injected from the injection gate 25. In step S13, the reinforcing bars 11 are also inserted from the glue injection opening 25, specifically, after the base layer tube 10 is cooled and shaped in the forming mold 2, the forming mold 2 is taken out from the forming apparatus 3, the mold head 24 is opened, and one end of the reinforcing bar 11 is inserted from the glue injection opening 15 until the reinforcing bar 11 is completely inserted into the base layer tube 10. The diameter of the glue injection opening 25 of the present embodiment is larger than or equal to the outer diameter of the bead 11, and the inner diameter of the molded base layer pipe 10 is larger than or equal to the diameter of the glue injection opening 25.

In this embodiment, the mold head 24 has a head vent hole 241, and the head vent hole 241 enables the tubular cavity of the molding die 2 to communicate with the space outside the molding die 2. In the process of implementing the molding process of the reinforced medical catheter of the present embodiment, the air pressure inside and outside the molding die 2 can be kept balanced, the molded base layer tube 10 or the finally molded reinforced medical catheter 1 is prevented from being deformed due to the influence of the change of the air pressure, and the molding die 2 can be quickly opened to take out the reinforced medical catheter 1 of the present embodiment, thereby realizing quick demolding.

With reference to fig. 15, 16 and 17, fig. 15 and 16 are a schematic view and a cross-sectional view of a molding apparatus according to a third embodiment of the present invention, respectively, and fig. 17 is an enlarged view of a region B of fig. 16. In the above embodiment, the first material liquid or the second material liquid is injected manually, and in the present embodiment, the first material liquid or the second material liquid is injected in a different manner, as shown in the figure, the forming mold 2 of the present embodiment omits a mold end socket compared with the forming mold of the second embodiment, and the shape of the end of the forming mold 2, at which the glue injection port 25 is opened, corresponds to the shape of the interlocking clamping groove 30221, and in addition, the forming apparatus 3 of the present embodiment further has a glue injection machine 35, and the glue injection machine 35 automatically injects the second material liquid into the tubular inner cavity of the forming mold 2 through the glue injection pipe 351, or injects the first material liquid into the base layer pipe 10. Specifically, a glue injection hole 3025 is formed in the clamping linkage shaft 302 in the present embodiment, one end of the glue injection pipe 351 is connected to the glue injector 35, and the other end of the glue injection pipe passes through the glue injection hole 3025 and is located in the tubular inner cavity of the forming mold 2, so that the glue injector 35 injects the second material liquid into the tubular inner cavity of the forming mold 2 through the glue injection pipe 351, or injects the first material liquid into the base layer pipe 10.

The structure of the clamping linkage shaft 302 of the present embodiment is different from the structure of the clamping linkage shaft of the above embodiments, the clamping linkage shaft 302 of the present embodiment omits the arrangement of the rotation shaft and the elastic member, only the clamping shaft 3022 is retained, and the clamping shaft 3022 directly penetrates through the bearing 306 of the movable base 305. The injection hole 3025 penetrates the grip shaft portion 3022 and communicates with the interlocking notch 30221. Of course, the clamping linkage shaft 302 of the present embodiment can also be used as the clamping linkage shaft of the above embodiments, and will not be described herein again.

In this embodiment, the glue injection pipe 351 includes a first pipe 351a and a second pipe 351b connected to the first pipe 351a, the first pipe 351a is connected to the glue injector 35, the second pipe 351b passes through the glue injection hole 3025 and the glue injection port 25 of the clamping linkage shaft 302 to communicate with the tubular cavity of the forming mold 2, and the outer diameter of the second pipe 351b is smaller than the outer diameter of the first pipe 351a, so that the speed of the first material liquid entering the base layer pipe 10 or the speed of the second material liquid entering the tubular cavity of the forming mold 2 can be accelerated. The external diameter of second body 351b is less than the internal diameter of injecting glue mouth 25, has the space between the outer wall of second body 351b and the inner wall of injecting glue mouth 25, so forming die 2's tubulose inner chamber communicates with the external world through this space to the atmospheric pressure inside and outside forming die 2 is balanced in the in-process of shaping enhancement mode medical catheter 1, makes the atmospheric pressure in forming die 2 the same with external atmospheric pressure, lets the enhancement mode medical catheter 1 after the cooling shaping take out in forming die 2 fast. In the present embodiment, since the automatic injection is adopted, the provision of the sealing member of the molding die 2 is omitted, and the function of the gap between the glue injection port 25 and the second tube 351b is the same as the function of providing the vent hole in the sealing member. Meanwhile, the forming mold 2 of the present embodiment is placed in the forming apparatus 3, when one end of the forming mold 2 is connected to the clamping interlocking shaft 302, the end surface of the forming mold 2 does not completely abut against the bottom of the interlocking clamping groove 30221, the outer diameter of the second tube 351b is smaller than the inner diameter of the glue injection hole 3025 that clamps the interlocking shaft 302, and the gas exhausted from the forming mold 2 flows to the outside from the gap between the end surface of the forming mold 2 and the interlocking clamping groove 30221 and the gap between the second tube 351b and the glue injection hole 3025, and similarly, the outside gas can also flow into the forming mold 2 from the gap between the end surface of the forming mold 2 and the interlocking clamping groove 30221 and the gap between the second tube 351b and the glue injection hole 3025, thereby balancing the gas pressure of the tubular inner cavity of the forming mold 2.

In the present embodiment, the glue injection pipe 351 is further provided with a control valve 353, and the control valve 353 is used to control the amount of the second material liquid injected into the molding die 2 or the first material liquid injected into the base layer pipe 10, so that the molding device 3 of the present embodiment can accurately control the pipe wall thickness of the molded enhanced medical catheters 1 with different lengths, and improve the molding efficiency.

In summary, according to the forming process of the enhanced medical catheter provided by the invention, the reinforcing rib is arranged on the inner wall of the base layer tube, the first material liquid is injected into the base layer tube, the first material liquid is uniformly attached to the inner wall of the base layer tube and covers the reinforcing rib in a manner of rotating the base layer tube, the reinforcing rib does not displace in the rotating process, and finally the first material liquid in the base layer tube is plasticized in a state of keeping the base layer tube rotating, so that the enhanced medical catheter is formed.

It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, article, or apparatus that comprises the element.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A molding process of an enhanced medical catheter is characterized by comprising the following steps:

providing a substrate tube;

arranging reinforcing ribs in the base layer tube;

injecting a first feed liquid into the base layer pipe;

rotating the base layer pipe filled with the first feed liquid, wherein the first feed liquid is uniformly distributed on the inner wall of the base layer pipe and covers the reinforcing ribs;

plasticizing the first feed liquid within the rotating base layer tube to form the reinforced medical catheter.

2. The process for forming an enhanced medical catheter of claim 1, wherein the step of providing the base tube comprises forming the base tube using a catheter extruder.

3. The process for forming an enhanced medical catheter as set forth in claim 2, wherein the step of rotating the base tube with the first feed liquid includes rotating the forming die by placing the base tube with the first feed liquid injected therein into a forming die having a tubular cavity, the forming die driving the base tube to rotate, the base tube having a shape corresponding to the shape of the tubular cavity of the forming die.

4. The process of claim 1, wherein the step of providing the base tube comprises the step of forming the base tube by:

providing a forming die having a tubular inner cavity;

injecting a second feed liquid into the tubular inner cavity of the forming die;

rotating the forming die filled with the second feed liquid to uniformly distribute the second feed liquid on the inner wall of the forming die;

plasticizing the second feed liquid within the forming die while rotating to form the substrate tube.

5. The process for forming an enhanced medical catheter of claim 4, wherein injecting the second feed liquid into the forming die further comprises preheating the second feed liquid prior to the step of injecting the second feed liquid into the forming die.

6. The process of claim 4, wherein plasticizing said second volume of fluid in said mold includes plasticizing said second volume of fluid by heating said rotating mold to a molding temperature of said second volume of fluid in said mold.

7. The process of claim 3 or 4, wherein plasticizing the first feed liquid in the rotating base tube comprises plasticizing the first feed liquid by heating the rotating forming die to a molding temperature of the first feed liquid in the base tube.

8. The process of claim 7, wherein said step of rotating said substrate tube with said first fluid further comprises preheating said forming die, and wherein said step of plasticizing said first fluid further comprises cooling and shaping said plasticized first fluid to form said reinforced medical catheter.

9. The process for forming an enhanced medical catheter of claim 1, further comprising preheating the first feed liquid prior to the step of injecting the first feed liquid into the base layer tube.

10. A reinforced medical catheter formed by the process of forming a reinforced medical catheter according to any one of claims 1-9.