CN115742236A - Manufacturing process of medical catheter with multi-section variable hardness - Google Patents
Manufacturing process of medical catheter with multi-section variable hardness Download PDFInfo
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- CN115742236A CN115742236A CN202211575940.4A CN202211575940A CN115742236A CN 115742236 A CN115742236 A CN 115742236A CN 202211575940 A CN202211575940 A CN 202211575940A CN 115742236 A CN115742236 A CN 115742236A
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Abstract
The invention discloses a manufacturing process of a medical catheter with multi-section variable hardness, which comprises the following steps: extruding raw materials; molding by a mold, molding the initial shape of the medical catheter by the mold, and planning and dividing the positions and the lengths of the hose section a and the hard pipe section b on the pipe body of the medical catheter; cooling and shaping, namely cooling the hose section a or the hard pipe section b for 0.1-2.1 h; modifying, namely soaking the cooled hose section a or the cooled hard pipe section b in a modified material for 1.1 to 8.1 hours; finishing the conduit; the medical catheter has the advantages of simple manufacturing process and convenient operation, can simultaneously have the characteristics of a soft structure and a hard structure on the medical catheter, reduces the production cost, has the advantage of gradually changing the hardness, enhances the integrity of the medical catheter, improves the flexibility and the mechanical property of the medical catheter, and is favorable for the long-time safe use of the medical catheter.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a manufacturing process of a medical catheter with multi-section variable hardness.
Background
The medical catheter is a tubular rubber product for medical treatment, and mainly plays an auxiliary role in the medical treatment process, for example, the medical catheter is used for catheterization and drainage, and the balloon dilatation catheter can play an auxiliary role in expanding a lumen and smoothing blood flow; medical catheters are widely used as common medical consumables, and are classified into a plurality of categories, such as infusion catheters, hemodialysis catheters, angiography catheters, catheters for intravascular interventional therapy, catheters for nervous systems and conveyor sheaths, drainage tubes for operations, soft-lens guide sheaths and the like according to different use functions; with the development of medical devices, the preparation process of medical catheters in different fields is different.
The patent CN101406712A discloses a method for preparing an antibacterial medical catheter, which is to prepare antibacterial powder, fully mix the antibacterial powder with plastic master batches, and extrude and mold the mixture to obtain a medical catheter with antibacterial function; the medical catheter manufactured by the process has the same overall performance and the same overall hardness degree, namely, the catheter can be integrally manufactured into a soft structure or a hard structure.
At present, when a catheter such as a soft endoscope guide sheath/conveyor sheath is manufactured, because the catheter such as the soft endoscope guide sheath/conveyor sheath needs to be provided with an actively bent part or a passively bent part, namely, the actively bent part is mostly of a soft structure, and the passively bent part is mostly of a hard structure, the catheter with the soft structure and the catheter with the hard structure need to be combined together to form a medical catheter in a hot melting welding, ultrasonic welding or bonding mode.
Disclosure of Invention
The invention aims to provide a manufacturing process of a medical catheter with multi-section variable hardness, which aims to solve the problems of complicated steps, high production cost, poor overall performance of the catheter and short service life of the existing manufacturing process in the background art.
In order to achieve the purpose, the invention provides the following technical scheme:
a process for manufacturing a medical catheter with multi-section hardness variation, which is composed of at least one flexible pipe section a and at least one hard pipe section b, comprises the following steps:
extruding raw materials, namely preheating the raw materials, putting the preheated raw materials into an extruding machine, extruding the raw materials by the extruding machine, and then sending the extruded raw materials into a die;
molding by a mold, namely molding the initial shape of the medical catheter by the mold, and planning and dividing the positions and the lengths of a hose section a and a hard pipe section b on the pipe body of the medical catheter;
homogenizing the pipe wall, and carrying out traction, stretching and extrusion retraction on the soft pipe section a or the hard pipe section b;
cooling and shaping, namely cooling the hose section a or the hard pipe section b for 0.1-2.1 h;
modifying, namely soaking the cooled hose section a or the cooled hard pipe section b in a modified material for 1.1 to 8.1 hours, wherein the modified material needs to be prepared into a modified solution at the temperature of between 10 and 150 ℃ for use;
and (3) drying, drying and cutting the modified catheter to obtain a finished catheter.
Furthermore, when the flexible pipe section a or the hard pipe section b is subjected to cooling treatment, the flexible pipe section a and the hard pipe section b are subjected to water cooling treatment at the same time, the cooling time of the flexible pipe section a is 0.3-1.1h, and the cooling time of the hard pipe section b is 0.9-1.5h.
Further, the hose section a is converted into air cooling treatment after the water cooling time of 0.3-1.1h, and the air cooling treatment of the hose section a is stopped after the water cooling time of the hard pipe section b.
Furthermore, in the modification treatment process, the modified material adopts reinforced resins, toughened resins or a hydrophilic coating, and the hydrophilic coating adopts PET plastics, PC plastics, ABS plastics, PA plastics or PPO plastics; during modification, the hose section a or the hard pipe section b is soaked in a holding tank filled with a modification solution at 20-120 ℃ for 1.5-6h.
Further, the hose section a is soaked in a toughening resin modified solution at the temperature of 30-80 ℃, and the soaking time is 1.6-3h.
Further, the hard pipe section b is soaked in a reinforced resin modified solution at the temperature of 40-110 ℃, and the soaking time is 2-5h.
Further, the hose section a or the hard hose section b is soaked in the hydrophilic coating modification solution for 2-3h, and then is placed in a UV curing machine for curing treatment, wherein the temperature of the hydrophilic coating modification solution is 50-90 ℃.
Further, the UV curing machine is connected with a clean air source through a high-pressure tee joint, residual moisture in the hose section a or the hard pipe section b is emptied, and the ventilation condition of the hose section a or the hard pipe section b is checked.
Furthermore, the preheating temperature of the raw materials is 10-80 ℃, and the raw materials adopt any one or more of medical grade PVC, TPU, TPE, PE, FEP, PEBAX, PA, terylene, polytetrafluoroethylene, polyurethane, PET plastic and silicon rubber.
Further, the heating temperature of the extruder is maintained at 100 to 300 ℃ and the injection pressure of the extruder is 60 to 900N.
The invention has the beneficial effects that: the invention can process the catheter tube by using the stepwise cooling and the modified solution in the extrusion molding process to manufacture each tube part with different hardness, so that one medical catheter has the characteristics of a soft structure and a hard structure at the same time, the production cost of the medical catheter is reduced, the medical catheter has the advantage of gradually changing hardness, the integrity of the medical catheter is enhanced, the flexibility and the mechanical property of the medical catheter are improved, the medical catheter is beneficial to long-time safe use, and meanwhile, the manufacturing process is simple, the operation is convenient, and the invention is suitable for large-scale production of the medical catheter.
Drawings
FIG. 1 is a process flow diagram of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example one
A manufacturing process of a medical catheter with multi-section variable hardness comprises the following steps:
extruding raw materials, namely preheating the raw materials, putting the preheated raw materials into an extruding machine, extruding the raw materials by the extruding machine, and then sending the extruded raw materials into a mold; wherein the preheating temperature of the raw materials is 50 ℃, the raw materials adopt but not limited to medical grade PVC, TPU, TPE or PE, the heating temperature of an extruding machine is kept at 210 ℃, and the injection pressure of the extruding machine is 400N;
molding by a mold, namely molding the initial shape of the medical catheter by the mold, and planning and dividing the positions and the lengths of a hose section a and a hard pipe section b on the pipe body of the medical catheter;
homogenizing the tube wall, and carrying out traction, stretching and extrusion retraction on the soft tube section a or the hard tube section b;
cooling and shaping, namely cooling the soft pipe section a or the hard pipe section b, and simultaneously performing water cooling treatment on the soft pipe section a and the hard pipe section b, wherein the cooling time of the soft pipe section a is 0.7h, and the cooling time of the hard pipe section b is 1.2h; after the water-cooling time of the hard pipe section b is over, the air-cooling of the soft pipe section a is stopped, namely the soft pipe section a is cooled by air cooling at the moment, and the air-cooling time is 0.5h;
modifying, namely soaking the cooled conduit, namely the hose section a or the hard pipe section b, in a hydrophilic coating modification solution for 2.5 hours, wherein the temperature of the hydrophilic coating modification solution is 70 ℃, placing the hose section a or the hard pipe section b in a UV (ultraviolet) light curing machine for curing, connecting the UV light curing machine with a clean air source through a high-pressure tee, evacuating residual water in the hose section a or the hard pipe section b, and checking the ventilation condition of the hose section a or the hard pipe section b; wherein, the modified material adopts a hydrophilic coating, and the hydrophilic coating adopts but not limited to PET plastic, PC plastic, ABS plastic, PA plastic or PPO plastic;
and (3) drying and cutting the modified catheter to obtain the medical catheter with multi-section variable hardness.
Example two
A manufacturing process of a medical catheter with multi-section variable hardness comprises the following steps:
extruding raw materials, wherein the preheating temperature of the raw materials is 10 ℃, the raw materials are PEBAX, PA, terylene or polytetrafluoroethylene, but not limited to the PEBAX, the PA, the terylene or the polytetrafluoroethylene, the heating temperature of an extruding machine is kept at 100 ℃, and the injection pressure of the extruding machine is 60N;
molding a mould, and planning and dividing the positions and the lengths of the hose section a and the hard pipe section b;
homogenizing the pipe wall, and carrying out traction, stretching and extrusion retraction on the soft pipe section a or the hard pipe section b;
cooling and shaping, namely cooling the hose section a or the hard pipe section b, and simultaneously carrying out water cooling treatment on the hose section a and the hard pipe section b, wherein the cooling time of the hose section a is 0.3h, and the cooling time of the hard pipe section b is 0.9h;
modification treatment: soaking the cooled and cooled hose section a in a toughening resin modified solution at the temperature of 30 ℃ for 1.6h; soaking the cooled hard pipe section b in a reinforced resin modified solution at 40 ℃ for 2h;
and (3) finishing the conduit: drying and cutting the modified catheter.
EXAMPLE III
A manufacturing process of a medical catheter with multi-section variable hardness comprises the following steps:
extruding raw materials, wherein the preheating temperature of the raw materials is 80 ℃, the raw materials are made of but not limited to medical TPU, PA, polyurethane or PET plastics, the heating temperature of an extruder is kept at 300 ℃, and the injection pressure of the extruder is 900N;
molding a mould, and planning and dividing the positions and the lengths of the hose section a and the hard pipe section b;
homogenizing the tube wall, and carrying out traction, stretching and extrusion retraction on the soft tube section a or the hard tube section b;
cooling and shaping, namely cooling the hose section a or the hard pipe section b, and simultaneously carrying out water cooling treatment on the hose section a and the hard pipe section b, wherein the cooling time of the hose section a is 1.1h, and the cooling time of the hard pipe section b is 1.5h;
the modification treatment comprises the steps of soaking the cooled hose section a or the cooled hard pipe section b in a hydrophilic coating modification solution for 3 hours, setting the temperature of the hydrophilic coating modification solution to be 90 ℃, placing the hydrophilic coating modification solution in a UV (ultraviolet) light curing machine for curing treatment, connecting the UV light curing machine with a clean air source through a high-pressure tee joint, exhausting residual moisture in the hose section a or the hard pipe section b, and checking the ventilation condition of the hose section a or the hard pipe section b; wherein, the modified material adopts a hydrophilic coating, and the hydrophilic coating adopts but not limited to PET plastic, PC plastic, ABS plastic, PA plastic or PPO plastic;
and (5) drying, drying and cutting the modified catheter to obtain a finished catheter product.
Example four
A manufacturing process of a medical catheter with multi-section variable hardness comprises the following steps:
extruding raw materials, wherein the preheating temperature of the raw materials is 40 ℃, the raw materials are made of but not limited to PET plastics, the heating temperature of an extruder is kept at 150 ℃, and the injection pressure of the extruder is 450N;
molding a mould, and drawing up the positions and the lengths of the soft pipe section a and the hard pipe section b;
homogenizing the pipe wall, and carrying out traction, stretching and extrusion retraction on the soft pipe section a or the hard pipe section b;
cooling and shaping, namely cooling the soft pipe section a or the hard pipe section b, and simultaneously performing water cooling treatment on the soft pipe section a and the hard pipe section b, wherein the cooling time of the soft pipe section a is 0.9h, and the cooling time of the hard pipe section b is 1h; after the water-cooling time of the hard pipe section b is over, the air-cooling of the soft pipe section a is stopped, and at the moment, the air-cooling of the soft pipe section a is carried out for 0.1 h;
modifying, namely soaking the cooled and cooled hose section a in a toughening resin modified solution at 50 ℃ for 2.2h;
and (3) finishing the conduit: drying and cutting the modified catheter.
EXAMPLE five
A manufacturing process of a medical catheter with multi-section variable hardness comprises the following steps:
extruding raw materials, wherein the preheating temperature of the raw materials is 20 ℃, the raw materials are silicon rubber without limitation, the heating temperature of an extruder is kept at 120 ℃, and the injection pressure of the extruder is 300N;
molding a mould, and planning and dividing the positions and the lengths of the hose section a and the hard pipe section b;
homogenizing the tube wall, and carrying out traction, stretching and extrusion retraction on the soft tube section a or the hard tube section b;
cooling and shaping, namely cooling the hose section a or the hard pipe section b, and simultaneously carrying out water cooling treatment on the hose section a and the hard pipe section b, wherein the cooling time of the hose section a is 0.5h, and the cooling time of the hard pipe section b is 1.1h; after the water cooling time of the hard pipe section b is over, the air cooling of the soft pipe section a is stopped, and at the moment, the air cooling of the soft pipe section a is carried out for 0.6 h;
modifying, namely soaking the cooled hard pipe section b in a 75 ℃ reinforced resin modified solution for 3.5h;
and (3) drying, drying and cutting the modified catheter to obtain a finished catheter.
The production parameters of the manufacturing process of the first to fifth embodiments are as follows:
table 1: process parameter table of manufacturing process use embodiment of medical catheter with multi-section variable hardness
The medical catheter manufactured by combining the production processes of the first embodiment and the fifth embodiment has the following effects: the medical catheter has the advantages of low production cost and gradual hardness change, so that one medical catheter has the characteristics of a soft structure and a hard structure, the integrity of the medical catheter is enhanced, the flexibility, the mechanical property and the biocompatibility of the medical catheter are improved, the wear resistance and the lubricating property of the medical catheter can be enhanced under the action of a modified solution, and the medical catheter is favorable for long-time safe use.
Wherein, the tube wall mentioned in the first to fifth embodiments is homogenized, and the flexible tube section a or the hard tube section b is drawn, stretched and extruded to retract; can retract through drawing and extrusion and carry out the pipe wall homogenization to the pipe wall of medical catheter, the tubular wall structure of outer medical catheter is more durable, and the interior pipe wall of pipe is more lubricated, makes things convenient for the pipe inner wall more penetrating, prevents that the foreign matter from being detained at the interior pipe wall of pipe, reduces the probability that the jam condition appears in the medical catheter inner wall when using, has prolonged the life of medical catheter to this makes things convenient for the permanent safe use of medical catheter.
It is specifically mentioned that the modified material is, but not limited to, reinforced resins, toughened resins or hydrophilic coating, and other materials such as polymer materials are prepared as modified solution as modified material, and are also applicable to the embodiment of the present invention, and the hydrophilic coating is, but not limited to, PET plastic, PC plastic, ABS plastic, PA plastic or PPO plastic; the polymer material is selected from, but not limited to, plastics, fibers, and paints.
It should be noted that the photocuring machine and the photocuring machine mentioned in the embodiments are conventional apparatuses and processes in the duct manufacturing process by connecting a clean air source, a plastic extruding machine, water cooling and air cooling through a high-pressure tee, and the structure and principle thereof are well known technologies in the market, and therefore are not described herein again.
The manufacturing process of the medical catheter with the multi-section variable hardness can produce multi-section medical catheters with a soft tube section a and a hard tube section b, such as the production of a soft endoscope guide sheath, a ureteral catheter, a ureteral stent, a central venous catheter, a hemodialysis catheter, a catheter sheath, an angiography catheter/guide catheter, a suction catheter, a pressure extension tube, a stomach tube, a double-cavity stomach tube, a drainage tube and an ablation catheter, wherein one part of the tube body is the hard tube section b, and the other part of the tube body is the soft tube section a, so that the practical use of the medical catheter is facilitated, different catheters are produced, and the production can be realized by only using different raw materials and different plastic extruding machine molds; wherein, can be according to the actual need of medical catheter, adjust the length, position and the quantity of hose section a and hard pipe section b to let medical catheter use convenience more.
Application example: if the ureteral stent manufactured by the manufacturing process of the medical catheter with the multi-section variable hardness, namely, two ends of the ureteral stent are set to be in a hose section a structure, the hose section a is respectively used for connecting a urinary bladder system and a renal pelvis system, and the hard pipe section b is used as a bridge for connecting the hose sections a at two ends, so that the discharge of urine is better guided.
The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above examples only express the preferred embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention; it should be noted that, for those skilled in the art, without departing from the concept of the present invention, several variations and modifications can be made which are within the scope of the present invention; in the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "fixed," and the like are to be construed broadly and can include, for example, fixed connections and removable connections.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. A manufacturing process of a medical catheter with multi-section variable hardness, which is composed of at least one flexible pipe section a and at least one hard pipe section b, is characterized by comprising the following steps:
extruding raw materials, namely preheating the raw materials, putting the preheated raw materials into an extruding machine, extruding the raw materials by the extruding machine, and then sending the extruded raw materials into a die;
molding by a mold, namely molding the initial shape of the medical catheter by the mold, and planning and dividing the positions and the lengths of a hose section a and a hard pipe section b on the pipe body of the medical catheter;
homogenizing the pipe wall, and carrying out traction, stretching and extrusion retraction on the soft pipe section a or the hard pipe section b;
cooling and shaping, namely cooling the hose section a or the hard pipe section b for 0.1-2.1 h;
performing modification treatment, namely soaking the cooled hose section a or the cooled hard pipe section b in a modified material for 1.1 to 8.1 hours, wherein the modified material needs to be prepared into a modified solution at the temperature of between 10 and 150 ℃ for use;
and (5) drying, drying and cutting the modified catheter to obtain a finished catheter product.
2. The process of making a multi-segmented variable stiffness medical catheter of claim 1, wherein: when the soft pipe section a or the hard pipe section b is subjected to cooling treatment, the soft pipe section a and the hard pipe section b are subjected to water cooling treatment simultaneously, the cooling time of the soft pipe section a is 0.3-1.1h, and the cooling time of the hard pipe section b is 0.9-1.5h.
3. The process of making a multi-segmented variable stiffness medical catheter of claim 2, wherein: and after the water-cooling time of the hard pipe section b is over, the air-cooling of the soft pipe section a is stopped.
4. A process for making a multi-segmented variable stiffness medical catheter as claimed in claim 1, wherein: in the modification treatment process, the modified material adopts reinforced resins, toughened resins or a hydrophilic coating, and the hydrophilic coating adopts PET plastics, PC plastics, ABS plastics, PA plastics or PPO plastics; during modification, the hose section a or the hard pipe section b is soaked in a holding tank filled with a modification solution at the temperature of 20-120 ℃ for 1.5-6h.
5. The process of making a multi-segmented variable stiffness medical catheter of claim 4, wherein: the hose section a is soaked in a toughening resin modified solution at the temperature of 30-80 ℃, and the soaking time is 1.6-3h.
6. The process of making a multi-segmented variable stiffness medical catheter of claim 4, wherein: and the hard pipe section b is soaked in a reinforced resin modified solution at the temperature of 40-110 ℃, and the soaking time is 2-5h.
7. A process for making a medical catheter according to claims 1 or 4, of variable stiffness in multiple sections, wherein: and after the hose section a or the hard tube section b is soaked in the hydrophilic coating modification solution for 2-3 hours, placing the hose section a or the hard tube section b in a UV (ultraviolet) curing machine for curing treatment, wherein the temperature of the hydrophilic coating modification solution is 50-90 ℃.
8. The process of making a multi-segmented variable stiffness medical catheter of claim 7, wherein: and the UV light curing machine is connected with a clean air source through a high-pressure tee joint, residual moisture in the hose section a or the hard pipe section b is emptied, and the ventilation condition of the hose section a or the hard pipe section b is checked.
9. The process of making a multi-segmented variable stiffness medical catheter of claim 1, wherein: the preheating temperature of the raw materials is 10-80 ℃, and the raw materials adopt any one or more of medical grade PVC, TPU, TPE, PE, FEP, PEBAX, PA, terylene, polytetrafluoroethylene, polyurethane, PET plastics and silicon rubber.
10. The process of making a multi-segmented variable stiffness medical catheter of claim 1, wherein: the heating temperature of the extruder is maintained at 100-300 ℃ and the injection pressure of the extruder is 60-900N.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211575940.4A CN115742236A (en) | 2022-12-09 | 2022-12-09 | Manufacturing process of medical catheter with multi-section variable hardness |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202211575940.4A CN115742236A (en) | 2022-12-09 | 2022-12-09 | Manufacturing process of medical catheter with multi-section variable hardness |
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| CN115742236A true CN115742236A (en) | 2023-03-07 |
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| CN202211575940.4A Pending CN115742236A (en) | 2022-12-09 | 2022-12-09 | Manufacturing process of medical catheter with multi-section variable hardness |
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