CN117224814A - Bendable reducing composite pipe and manufacturing method thereof - Google Patents
Bendable reducing composite pipe and manufacturing method thereof Download PDFInfo
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- CN117224814A CN117224814A CN202311523456.1A CN202311523456A CN117224814A CN 117224814 A CN117224814 A CN 117224814A CN 202311523456 A CN202311523456 A CN 202311523456A CN 117224814 A CN117224814 A CN 117224814A
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- 239000002131 composite material Substances 0.000 title claims abstract description 83
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 28
- 239000011347 resin Substances 0.000 claims abstract description 93
- 229920005989 resin Polymers 0.000 claims abstract description 93
- 230000007704 transition Effects 0.000 claims abstract description 57
- 239000004033 plastic Substances 0.000 claims description 79
- 229910052751 metal Inorganic materials 0.000 claims description 46
- 239000002184 metal Substances 0.000 claims description 46
- 238000009954 braiding Methods 0.000 claims description 37
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 20
- 229920006122 polyamide resin Polymers 0.000 claims description 20
- 229920000570 polyether Polymers 0.000 claims description 20
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 17
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 17
- 238000000034 method Methods 0.000 claims description 16
- -1 polytetrafluoroethylene Polymers 0.000 claims description 15
- 238000013329 compounding Methods 0.000 claims description 12
- 239000004812 Fluorinated ethylene propylene Substances 0.000 claims description 6
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 claims description 6
- 229920009441 perflouroethylene propylene Polymers 0.000 claims description 6
- 230000000149 penetrating effect Effects 0.000 claims description 3
- 238000004804 winding Methods 0.000 claims description 3
- 238000005253 cladding Methods 0.000 abstract description 2
- 239000010410 layer Substances 0.000 description 114
- 210000004204 blood vessel Anatomy 0.000 description 15
- 230000008569 process Effects 0.000 description 8
- 230000000694 effects Effects 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 229910001220 stainless steel Inorganic materials 0.000 description 3
- 239000010935 stainless steel Substances 0.000 description 3
- 229920002614 Polyether block amide Polymers 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 210000003709 heart valve Anatomy 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 230000006798 recombination Effects 0.000 description 2
- 238000005215 recombination Methods 0.000 description 2
- 241001391944 Commicarpus scandens Species 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009940 knitting Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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- Rigid Pipes And Flexible Pipes (AREA)
Abstract
The embodiment of the application provides a bendable reducing composite pipe and a manufacturing method thereof, which relate to the technical field of medical catheters and comprise a straight section, a transition section and a bendable section which are integrally formed, wherein one end of the transition section is connected with the straight section, and the other end of the transition section is connected with the bendable section; the inner diameter of the straight section is smaller than that of the bendable section, and the inner diameter of the transition section gradually increases from one end of the straight section to one end of the bendable section; the outer side walls of the straight section and the bendable section are both provided with resin layers; the changeover portion includes braced skeleton, and braced skeleton includes annular structure, and annular structure evenly sets up along the extending direction of changeover portion, and braced skeleton cladding has resin. By the arrangement of the embodiment of the application, the composite pipe with higher strength, better performance and better functionality is provided.
Description
Technical Field
The application relates to the technical field of medical catheters, in particular to a bendable reducing composite tube and a manufacturing method thereof.
Background
The reducing composite tube can be used for heart valve replacement operation, and pain and operation risk caused by larger tube body size in operation can be effectively reduced by reducing the tube body of the reducing composite tube.
In the related art, the reducing of the reducing composite pipe is generally carried out by directly braiding or adopting a single-layer PEBAX (polyether block polyamide) resin layer at the transition section of the pipe diameter.
However, both the direct braiding mode and the single polyether block polyamide resin layer are easy to cause insufficient radial supporting rigidity and connecting force of the pipe diameter transition section, so that the transition section is broken, and the performance of the composite pipe is affected.
Disclosure of Invention
The embodiment of the application provides a bendable variable-diameter composite pipe and a manufacturing method thereof, which are used for solving the technical problems that the radial support rigidity and the connecting force of the composite pipe in the pipe diameter transition section in the related art are insufficient, so that the transition section is broken, and the performance of the composite pipe is affected.
In a first aspect, an embodiment of the present application provides a bendable reducing composite pipe, including a straight section, a transition section and a bendable section that are integrally formed, one end of the transition section is connected with the straight section, and the other end of the transition section is connected with the bendable section;
the inner diameter of the straight section is smaller than that of the bendable section, and the inner diameter of the transition section gradually increases from one end of the straight section to one end of the bendable section;
the outer side walls of the straight section and the bendable section are both provided with resin layers;
the changeover portion includes braced skeleton, and braced skeleton includes annular structure, and annular structure evenly sets up along the extending direction of changeover portion, and braced skeleton intussuseption is filled with resin.
In one possible implementation, the support skeleton includes a connection portion and a support portion;
the connecting part is of an annular structure, the supporting part is a supporting rod, one end of the supporting rod is arranged on the annular side wall of the connecting part, the other end of the supporting rod extends back to the connecting part, and the supporting rods are uniformly arranged on the annular side wall of the connecting part at intervals;
the connecting portion is arranged towards the bendable section, and the supporting rod is arranged towards the straight section.
In one possible implementation, an end of the support rod facing away from the connection portion is provided with an abutment portion extending along the connection portion from an end of the support rod.
In one possible implementation, the straight section comprises, from inside to outside, a first plastic layer, a metal braid and a first resin layer in that order;
the first plastic layer comprises polytetrafluoroethylene; the first resin layer includes a polyether block polyamide resin;
wherein the thickness of the first plastic layer is 0.05 mm-0.1 mm; the thickness of the braiding wires in the metal braiding layer is 0.025-0.05 mm, and the width of the braiding wires is 0.06-0.15 mm, wherein the width of the braiding wires is less than or equal to 5 times the thickness of the braiding wires; the thickness of the first resin layer is 0.03mm to 0.1mm.
In one possible implementation, the bendable section comprises a second plastic layer, a metal spring layer and a second resin layer in sequence from inside to outside;
the second plastic layer comprises polytetrafluoroethylene; the second resin layer includes a polyether block polyamide resin; the metal spring layer comprises a spring, and the spring is wound between the second plastic layer and the second resin layer;
wherein the thickness of the second plastic layer is 0.05 mm-0.1 mm; the width of the spring wire in the metal spring layer is 0.15-0.35 mm, and the thickness of the spring wire is 0.03-0.15 mm, wherein the width of the spring wire is less than or equal to 5 times the thickness of the spring wire; the thickness of the second resin layer is 0.03mm to 0.1mm.
In one possible implementation, the composite tube further comprises a tip section disposed at the end of the bendable section;
the outer side wall of one end of the tip section, which is back to the bendable section, is provided with a chamfer.
In one possible implementation, the tip section comprises, from inside to outside, a third plastic layer and a third resin layer in sequence;
the third plastic layer comprises polytetrafluoroethylene; the third resin layer includes a polyether block polyamide resin and a developer.
In a second aspect, an embodiment of the present application further provides a method for manufacturing a bendable reducing composite pipe, where the manufacturing method is used for manufacturing the bendable reducing composite pipe according to any one of the first aspect; the manufacturing method comprises the following steps:
sleeving a first plastic pipe on a first section of the mandrel die, and sleeving a second plastic pipe on a second section of the mandrel die; wherein the first section of the mandrel mould and the straight section of the composite pipe are mutually matched, and the second section of the mandrel mould and the bendable section of the composite pipe are mutually matched; wherein the first plastic tube and the second plastic tube both comprise polytetrafluoroethylene;
penetrating the support framework into a third section of the mandrel die, and aligning two ends of the support framework with the first section and the second section respectively; the third section of the mandrel die and the transition section of the composite pipe are mutually matched;
sleeving the first plastic pipe, the second plastic pipe and the outer side wall of the supporting framework with resin pipe; wherein the resin tube comprises a polyether block polyamide resin;
the resin tube is thermally compounded.
In one possible implementation, after the step of threading the support skeleton into the third section of the mandrel mold and aligning the two ends of the support skeleton with the first section and the second section, respectively, the method further includes:
a metal braid layer is formed by braiding metal braid wires between the first plastic tube and the resin tube, and a metal spring layer is formed by winding spring wires between the second plastic tube and the resin tube.
In one possible implementation, the step of thermally compounding the resin tube is preceded by:
and the outer side wall of the resin pipe is sleeved with a fluorinated ethylene propylene heat shrinkage pipe, and the inner diameter of the fluorinated ethylene propylene heat shrinkage pipe is 0.2-0.3 mm larger than the diameter of each section.
The embodiment of the application provides a bendable variable-diameter composite tube, in the embodiment of the application, the inner diameter of a straight section is smaller than the inner diameter of a bendable section, when the composite tube is subjected to an intra-cardiac valve replacement operation through a blood vessel of a patient, as the straight section and the bendable section adopt variable-diameter designs, the compression on the blood vessel can be reduced due to the relatively smaller pipe diameter of the straight section on the premise of ensuring the valve conveying and recovering functions, the pain of the patient in the operation is relieved, and the operation risk is reduced. According to the embodiment of the application, the support framework is arranged on the transition section and comprises the annular structure, the support structure can be supported on the straight section, when the bendable section needs to be bent, certain stress is generated on the transition section, and the strength of the transition section can be improved through the arrangement of the support framework; furthermore, in the embodiment of the application, the supporting framework is coated with resin, and on one hand, the transition section, the straight section and the transition section can be connected with the bendable section through filling of the resin, so that the connection between the transition section and the straight section and between the transition section and the bendable section is more compact and smooth, thereby being beneficial to alleviating pain of patients in operation; on the other hand, through at support skeleton cladding resin, can further improve the joint force of changeover portion, avoid the changeover portion to appear splitting. By the arrangement of the embodiment of the application, the composite pipe with higher strength, better performance and better functionality is provided.
The embodiment of the application also provides a manufacturing method of the bendable reducing composite pipe, which is used for manufacturing the bendable reducing composite pipe in any one of the above technical schemes, so that the bendable reducing composite pipe has all the beneficial effects of any one of the above technical schemes, and is not repeated here.
Drawings
The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute a limitation on the application. In the drawings:
FIG. 1 is a schematic structural view of a bendable reducing composite pipe according to an embodiment of the present application;
FIG. 2 is a schematic view of the structure of the support framework of FIG. 1;
FIG. 3 is a schematic view of a mandrel mold according to an embodiment of the present application;
fig. 4 is a flow chart of a method for manufacturing a bendable reducing composite pipe according to an embodiment of the application.
Reference numerals illustrate:
100-straight sections; 200-transition section; 300-bendable sections; 400-tip segment; 500-mandrel mold;
110-a first plastic layer; 120-metal braid; 130-a first resin layer; 210-a supporting framework; 211-a connection; 212-a support; 213-abutment; 310-a second plastic layer; 320-a metal spring layer; 330-a second resin layer; 410-a third plastic layer; 420-a third resin layer; 430-chamfering.
Detailed Description
In order to make the technical solution of the present application better understood by those skilled in the art, the technical solution of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present application without making any inventive effort, shall fall within the scope of the present application.
The reducing composite tube can be used for heart valve replacement operation, and pain and operation risk caused by larger tube body size in operation can be effectively reduced by reducing the tube body of the composite tube.
In the related art, the diameter of the composite pipe is generally changed by directly knitting or using a single PEBAX (polyether block polyamide) resin layer at the transition section of the pipe diameter.
However, both the direct braiding mode and the single polyether block polyamide resin layer are easy to cause insufficient radial supporting rigidity and connecting force of the pipe diameter transition section, so that the transition section is broken, and the performance of the composite pipe is affected.
Therefore, the embodiment of the application provides a bendable variable-diameter composite pipe and a manufacturing method thereof, so as to solve the technical problems that the radial supporting rigidity and the connecting force of the composite pipe in the related art are insufficient at the pipe diameter transition section, so that the transition section of a catheter is broken in the use process, and the performance of the composite pipe is affected.
FIG. 1 is a schematic structural view of a bendable reducing composite pipe according to an embodiment of the present application; fig. 2 is a schematic structural view of the support frame of fig. 1.
In a first aspect, an embodiment of the present application provides a bendable reducing composite pipe, referring to fig. 1 and 2, including a straight section 100, a transition section 200 and a bendable section 300 that are integrally formed, wherein one end of the transition section 200 is connected to the straight section 100, and the other end of the transition section 200 is connected to the bendable section 300;
the inner diameter of the straight section 100 is smaller than the inner diameter of the bendable section 300, and the inner diameter of the transition section 200 gradually increases from one end of the straight section 100 to one end of the bendable section 300;
the outer sidewalls of the straight section 100 and the bendable section 300 are each provided as a resin layer;
the transition section 200 includes a support skeleton 210, the support skeleton 210 includes an annular structure, the annular structure is uniformly arranged along the extending direction of the transition section 200, and the support skeleton 210 is coated with resin.
In the embodiment, the composite tube is inserted into the blood vessel from one end of the bendable section 300.
From the above description, it can be seen that the following technical effects are achieved:
in the embodiment of the application, the inner diameter of the straight section 100 is set smaller than the inner diameter of the bendable section 300, so that when the composite tube is subjected to the valve replacement operation in the heart through the blood vessel of a patient, the straight section 100 and the bendable section 300 adopt the diameter-variable design, and the relatively smaller pipe diameter of the straight section 100 can reduce the compression on the blood vessel, lighten the pain of the patient in the operation and reduce the operation risk on the premise of ensuring the valve conveying and recovering functions. In the embodiment of the present application, the supporting framework 210 is disposed on the transition section 200, and the supporting framework 210 includes an annular structure, which can be supported on the straight section 100, when the foldable section 300 needs to be folded, a certain stress is generated on the transition section 200, and the strength of the transition section 200 can be improved through the disposition of the supporting framework 210; further, in the embodiment of the present application, the supporting framework 210 is coated with resin, and by coating with resin, on one hand, the transition section 200, the flat section 100, the transition section 200 and the bendable section 300 can be connected, so that the connection between the transition section 200 and the flat section 100 and the bendable section 300 is more compact and smooth, thereby helping to relieve pain of patients in operation; on the other hand, by coating the supporting frame 210 with resin, the connection force of the transition section 200 can be further improved, and the transition section 200 is prevented from being broken. By the arrangement of the embodiment of the application, the composite pipe with higher strength, better performance and better functionality is provided.
In some examples, the support frame 210 includes a connection portion 211 and a support portion 212;
the connecting part 211 is arranged into an annular structure, the supporting part 212 is arranged into a supporting rod, one end of the supporting rod is arranged on the annular side wall of the connecting part 211, the other end of the supporting rod extends back to the connecting part 211, and a plurality of supporting rods are uniformly arranged on the annular side wall of the connecting part 211 at intervals;
the connection portion 211 is disposed toward the bendable section 300 and the support rod is disposed toward the flat section 100.
It should be noted that, the supporting rod has a certain elasticity, the connecting portion 211 is disposed towards the foldable section 300, the supporting rod is disposed towards the flat section 100, and the inner diameter of the transition section 200 gradually increases from one end of the flat section 100 to one end of the foldable section 300, so that the diameter of the circular ring enclosed by the supporting rod gradually decreases from the transition section 200 to the flat section 100.
Illustratively, a plurality of support skeletons 210 are provided, the plurality of support skeletons 210 are uniformly spaced along the extending direction of the transition section 200, and the diameter of the connecting portion 211 gradually decreases from the bendable section 300 to the straight section 100.
According to the embodiment of the application, the connection part 211 is arranged, so that the support effect on the transition section 200 can be achieved, and the connection force of the transition section 200 is enhanced, and further, the support rod is arranged on the annular side wall of the connection part 211, so that on one hand, the connection force of the transition section 200 is improved, on the other hand, the support rod can be firmly clamped in the resin through slight deformation of the support rod, and therefore, the fixation of the resin to the support framework 210 is improved, and the strength of the transition section 200 is further improved, namely, the connection force of the transition section 200 is improved.
Illustratively, an end of the support rod facing away from the connection portion 211 is provided with an abutment 213, the abutment 213 extending from an end of the support rod along the connection portion 211.
The support rod and the abutting portion 213 form a T-shape therebetween.
According to the embodiment of the application, through the arrangement of the abutting part 213, the abutting part 213 is matched with the resin filled in the supporting framework 210, so that the supporting framework 210 is clamped in the resin more firmly, the fixation of the resin to the supporting framework 210 is improved, and the connecting force of the transition section 200 is further improved.
In other examples, straight section 100 includes, in order from inside to outside, first plastic layer 110, metal braid 120, and first resin layer 130;
the first plastic layer 110 comprises polytetrafluoroethylene; the first resin layer 130 includes a polyether block polyamide resin;
wherein, the thickness of the first plastic layer 110 is 0.05 mm-0.1 mm; the thickness of the braiding wires in the metal braiding layer 120 is 0.025 mm-0.05 mm, the width of the braiding wires is 0.06 mm-0.15 mm, and the width of the braiding wires is less than or equal to 5 times of the thickness of the braiding wires due to the limitation of processing capability and the consideration of processing cost; the thickness of the first resin layer 130 is 0.03mm to 0.1mm.
The metal braid wires may be provided as stainless steel flat wires.
For example, the first resin layer 130 may be specifically configured as pebax5533, which is a type of polyether block polyamide resin, and the first resin layer 130 may be configured as another material having a hardness similar to that of the polyether block polyamide resin.
In the embodiment of the present application, the innermost side wall of the straight section 100 is set as the first plastic layer 110, the first plastic layer 110 includes Polytetrafluoroethylene (PTFE), and the thickness of the first plastic layer 110 is set to be 0.05 mm-0.1 mm, when the thickness of the first plastic layer 110 is less than 0.05mm, on one hand, the processing technology of the first plastic layer 110 becomes difficult due to the reduced thickness of the first plastic layer 110, so that the manufacturing cost of the first plastic layer 110 is greatly increased; on the other hand, since the straight section 100 needs to have a certain rigidity, the straight section 100 is rendered more flexible when the thickness of the first plastic layer 110 is smaller. When the thickness of the first plastic layer 110 is greater than 0.1mm, the diameter of the straight section 100 is increased, which affects the penetration of the straight section 100 into the patient's blood vessel. Therefore, the thickness of the first plastic layer 110 is set to be 0.05 mm-0.1 mm, so that the cost is reasonable, the straight section 100 can be kept straight conveniently, and the pipe diameter of the straight section 100 can be ensured.
The thickness of the metal braiding wires is set to be 0.025-0.05 mm, and it is to be noted that the metal braiding wires are set to be flat, when the thickness of the metal braiding wires is smaller than 0.025mm, the corresponding widths of the braiding wires are not larger than 0.125mm, after the metal braiding wires are braided, the radial supporting force of the catheter is insufficient, meanwhile, the catheter is softer and flexible, the effect that the straight section 100 keeps straight in actual use is reduced, when the thickness of the metal braiding wires is larger than 0.05mm, the braiding wires are larger, the braiding wires are easy to collapse, the outer side wall of the straight section 100 is rough, and the rough outer wall is easy to damage blood vessels of patients. Further, the width range of the metal braiding wires is set to be 0.06 mm-0.15 mm according to the thickness of the braiding layers, the number of braiding ingots of the metal braiding wires is 8-32 ingots under the thickness range and the width range, and the braiding mode of the metal braiding wires can be 1-1, 1-2 or 2-2 cross braiding.
In the embodiment of the application, the thickness of the first resin layer 130 is set to be 0.03-0.1 mm, when the thickness of the first resin layer 130 is smaller than 0.03mm, the metal braiding layer 120 easily passes through the first resin layer 130 and is exposed out of the first resin layer 130, so that the outer side wall of the straight section 100 is easily rough, and the rough outer wall easily damages the blood vessel of a patient; when the thickness of the first resin layer 130 is greater than 0.1mm, the diameter of the straight section 100 becomes larger, the larger the pipe body diameter of the composite pipe is, the lower the thermal compounding efficiency of the composite pipe in the processing process is, and at the same time, the difficulty of thermal compounding in the processing process of the composite pipe is increased due to the increase of the wall thickness of the resin layer 130. Therefore, the thickness of the first resin layer 130 is set to be 0.03-0.1 mm, so that the heat recombination efficiency in the processing process of the composite pipe is improved by the flat section, and the difficulty in heat recombination in the processing process of the composite pipe is reduced. Further, the smoothness of the straight section 100 is ensured, and the diameter of the straight section 100 can be controlled within a certain range.
In other examples, the deflectable segment 300 includes, in order from inside to outside, a second plastic layer 310, a metal spring layer 320, and a second resin layer 330;
the second plastic layer 310 comprises polytetrafluoroethylene; the second resin layer 330 includes a polyether block polyamide resin; the metal spring layer 320 includes a spring wound between the second plastic layer 310 and the second resin layer 330;
wherein, the thickness of the second plastic layer 310 is 0.05 mm-0.1 mm; the width of the spring wire in the metal spring layer 320 is 0.15 mm-0.35 mm, and the thickness of the spring wire is 0.03 mm-0.15 mm, and the width of the spring wire is less than or equal to 5 times the thickness of the spring wire due to the limitation of processing capability and the consideration of processing cost; the thickness of the second resin layer 330 is 0.03mm to 0.1mm.
The springs may be provided as stainless steel springs or nickel titanium springs, for example.
In the embodiment of the present application, the innermost side of the bendable section 300 is set as the second plastic layer 310, the second plastic layer 310 includes Polytetrafluoroethylene (PTFE), and the thickness of the second plastic layer 310 is set to be 0.05 mm-0.1 mm, when the thickness of the second plastic layer 310 is less than 0.05mm, the processing process of the second plastic layer 310 becomes difficult due to the reduced thickness of the second plastic layer 310, thereby greatly increasing the manufacturing cost of the second plastic layer 310. When the thickness of the first plastic layer 110 is greater than 0.1mm, on one hand, the diameter of the bendable section 300 is increased, which affects the bendable section 300 to enter the blood vessel of the patient; on the other hand, the rigidity of the bendable section 300 is increased, so that the bendable section 300 is not easy to bend. Therefore, the thickness of the second plastic layer 310 is set to be 0.05 mm-0.1 mm, so that the cost is reasonable, the bendable performance of the bendable section 300 can be guaranteed, and the pipe diameter of the bendable section 300 can be guaranteed.
According to the embodiment of the application, the width of the spring wire in the metal spring layer 320 is 0.15-0.35 mm, and the spring wire is required to be flat, when the width of the spring wire is smaller than 0.15mm, the radial supporting force of the spring wire is insufficient and the spring wire is easy to break when the foldable section 300 is folded; when the width of the spring wire is larger than 0.35mm, the spring wire is easy to collapse due to stress torsion at the tail of the spring after the spring wire is wound around the spring, so that the outer side wall of the foldable section 300 is rough, and the rough outer wall is easy to damage the blood vessel of a patient; meanwhile, the area of a single unbonded surface of the second plastic layer 310 and the second resin layer 330 is increased, so that the second plastic layer 310 and the second resin layer 330 are easy to separate after the composite pipe is thermally compounded, and the bending performance of the composite pipe is affected. Further, the thickness range of the spring wire is set to be 0.03mm to 0.15mm according to the width of the spring wire, and in order to further improve the radial supporting force of the metal spring layer 320, the interval between adjacent spring wires is set to be 0.5 times to 0.1 times the width of the spring wire in the embodiment of the present application. Therefore, in the embodiment of the application, the width of the spring wire in the metal spring layer 320 is set to be 0.15 mm-0.35 mm, the thickness is set to be 0.03 mm-0.15 mm, and the interval between adjacent spring wires is set to be 0.5-0.1 times of the width of the spring wire, so that not only the elastic bending of the bendable section 300 is ensured, but also the radial supporting force of the bendable section 300 is ensured.
In the embodiment of the application, the thickness of the second resin layer 330 is set to be 0.03-0.1 mm, when the thickness of the second resin layer 330 is smaller than 0.03mm, the spring layer easily passes through the second resin layer 330 and is exposed out of the second resin layer 330, so that the outer side wall of the bendable section 300 is easily rough, and the rough outer wall easily damages the blood vessel of a patient; when the thickness of the second resin layer 330 is greater than 0.1mm, the diameter of the bendable section 300 becomes larger, the larger the pipe body diameter of the composite pipe is, the lower the thermal compounding efficiency in the composite pipe processing is, and at the same time, the difficulty of thermal compounding in the composite pipe processing is also caused by the increase of the wall thickness of the second resin layer 330. Therefore, the thickness of the second resin layer 330 is set to be 0.03 mm-0.1 mm, so that the smoothness of the bendable section 300 is ensured, the diameter and thickness of the bendable section 300 are controlled within a certain range, the thermal compounding efficiency in the composite pipe processing process is ensured, and the thermal compounding difficulty in the composite pipe processing process is reduced.
Illustratively, the composite tube further includes a tip section 400, the tip section 400 being disposed at the end of the deflectable section 300;
the outer side wall of the end of the tip section 400 facing away from the bendable section 300 is provided with a chamfer 430.
According to the embodiment of the application, through the arrangement of the tip section 400, and the chamfer 430 is arranged on the outer side wall of one end of the tip section 400, which is opposite to the bendable section 300, when the composite tube stretches into a patient blood vessel, the composite tube is guided by the chamfer 430 of the tip section 400, and firstly enters the patient blood vessel from the tip section 400, and through the arrangement of the tip section 400, the composite tube is enabled to enter the patient blood vessel more smoothly.
Illustratively, the tip segment 400 includes, in order from inside to outside, a third plastic layer 410 and a third resin layer 420;
the third plastic layer 410 comprises polytetrafluoroethylene; the third resin layer 420 includes a developer and a polyether block polyamide resin, wherein the developer is generally uniformly incorporated in the polyether block polyamide resin when embodied.
The embodiment of the present application is configured such that the tip section 400 includes a third plastic layer 410 and a third resin layer 420 in order from inside to outside, and the third plastic layer 410 includes polytetrafluoroethylene; the third resin layer 420 includes a polyether block polyamide resin to which a developer is added, and an innermost layer material and an outermost layer material thereof are consistent with the straight section 100 and the bendable section 300, thereby facilitating the integral molding of the composite tube. Further, embodiments of the present application facilitate positioning of the composite tubing with the developer as it enters the patient's blood vessel by adding the developer to the third resin layer 420.
FIG. 3 is a schematic view of a mandrel mold according to an embodiment of the present application; fig. 4 is a flow chart of a method for manufacturing a bendable reducing composite pipe according to an embodiment of the application.
In a second aspect, referring to fig. 3 and fig. 4, an embodiment of the present application further provides a method for manufacturing a bendable reducing composite pipe, where the manufacturing method is used to manufacture a bendable reducing composite pipe according to any one of the first aspect; the manufacturing method comprises the following steps:
s1: sleeving a first plastic pipe on a first section of the mandrel die 500, and sleeving a second plastic pipe on a second section of the mandrel die 500; wherein the first section of the mandrel die 500 and the straight section 100 of the composite tube are mutually adapted, and the second section of the mandrel die 500 and the bendable section 300 of the composite tube are mutually adapted; wherein the first plastic tube and the second plastic tube both comprise polytetrafluoroethylene;
the worker sleeves a first plastic tube on a first section of the mandrel die 500 and a second plastic tube on a second section of the mandrel die 500.
It should be noted that, the mandrel mold 500 may be configured as a stainless steel member, the diameter of the mandrel mold 500 is the same as the inner diameter of the composite tube, and the surface of the mandrel mold 500 is smooth and has no foreign matters.
S2: penetrating the support framework 210 into the third section of the mandrel die 500, and aligning the two ends of the support framework 210 with the first section and the second section respectively; wherein the third section of the mandrel die 500 and the transition section 200 of the composite pipe are mutually adapted;
s3: metal braid 120 is formed by braiding metal braid wires between a first plastic tube and a resin tube, and metal spring layer 320 is formed by winding spring wires between a second plastic tube and a resin tube.
In particular implementations, the spring wire tail end and the metal braid wire tail end and the metal piece may be welded to prevent movement of the spring and metal braid wire.
S4: sleeving the first plastic pipe, the second plastic pipe and the outer side wall of the supporting framework 210 with resin pipe; wherein the resin tube comprises a polyether block polyamide resin;
namely, the resin tube is sleeved outside the metal braid 120, the supporting frame 210 and the metal spring layer 320, wherein the diameter size of the resin tube is greater than 0.2mm of the diameter size of the metal braid 120, the diameter size of the resin tube is greater than 0.2mm of the diameter size of the circular ring of the supporting frame 210, and the diameter size of the resin tube is greater than 0.2mm of the diameter size of the metal spring layer 320.
S5: the resin tube is thermally compounded.
Illustratively, the thermal compounding temperature is greater than 220 ℃, and the thermal compounding speed is less than 2.0mm/S.
In specific implementation, the length of the mandrel die 500 is greater than 200mm of the length of the composite pipe body, after thermal compounding is completed, the tip section 400 is sleeved with the fluorinated ethylene propylene heat-shrinkable tube, the mandrel die 500 is used as an inner lining, and the fluorinated ethylene propylene heat-shrinkable tube is subjected to heat treatment, wherein the heat treatment temperature is about 250 ℃ and the time is 30S.
The embodiment of the application also provides a manufacturing method of the bendable reducing composite pipe, which is used for manufacturing the bendable reducing composite pipe in any one of the above technical schemes, so that the bendable reducing composite pipe has all the beneficial effects of any one of the above technical schemes, and is not repeated here.
It is to be understood that, based on the several embodiments provided in the present application, those skilled in the art may combine, split, reorganize, etc. the embodiments of the present application to obtain other embodiments, which all do not exceed the protection scope of the present application.
The foregoing detailed description of the embodiments of the present application further illustrates the purposes, technical solutions and advantageous effects of the embodiments of the present application, and it should be understood that the foregoing is merely a specific implementation of the embodiments of the present application, and is not intended to limit the scope of the embodiments of the present application, and any modifications, equivalent substitutions, improvements, etc. made on the basis of the technical solutions of the embodiments of the present application should be included in the scope of the embodiments of the present application.
Claims (10)
1. The bendable reducing composite pipe is characterized by comprising a straight section (100), a transition section (200) and a bendable section (300) which are integrally formed, wherein one end of the transition section (200) is connected with the straight section (100), and the other end of the transition section (200) is connected with the bendable section (300);
the inner diameter of the straight section (100) is smaller than that of the bendable section (300), and the inner diameter of the transition section (200) gradually increases from one end of the straight section (100) to one end of the bendable section (300);
the outer side walls of the straight section (100) and the bendable section (300) are both provided with resin layers;
the transition section (200) comprises a supporting framework (210), the supporting framework (210) comprises an annular structure, the annular structure is uniformly arranged along the extending direction of the transition section (200), and the supporting framework (210) is coated with resin.
2. The bendable reducing composite pipe according to claim 1, wherein the support frame (210) comprises a connecting portion (211) and a supporting portion (212);
the connecting part (211) is of an annular structure, the supporting part (212) is a supporting rod, one end of the supporting rod is arranged on the annular side wall of the connecting part (211), the other end of the supporting rod extends back to the connecting part (211), and a plurality of supporting rods are uniformly arranged on the annular side wall of the connecting part (211) at intervals;
the connecting portion (211) is arranged towards the bendable section (300), and the support rod is arranged towards the straight section (100).
3. A bendable reducing composite pipe according to claim 2, characterized in that an end of the support rod facing away from the connecting portion (211) is provided with an abutment portion (213), the abutment portion (213) extending from the end of the support rod along the connecting portion (211).
4. A bendable reducing composite pipe according to any of claims 1-3, wherein the straight section (100) comprises, in order from inside to outside, a first plastic layer (110), a metal braid (120) and a first resin layer (130);
the first plastic layer (110) comprises polytetrafluoroethylene; the first resin layer (130) includes a polyether block polyamide resin;
wherein the thickness of the first plastic layer (110) is 0.05 mm-0.1 mm; the thickness of the braiding wires in the metal braiding layer (120) is 0.025-0.05 mm, and the width of the braiding wires is 0.06-0.15 mm, wherein the width of the braiding wires is less than or equal to 5 times the thickness of the braiding wires; the thickness of the first resin layer (130) is 0.03-0.1 mm.
5. A bendable reducing composite pipe according to any of claims 1-3, wherein the bendable section (300) comprises, in order from inside to outside, a second plastic layer (310), a metal spring layer (320) and a second resin layer (330);
the second plastic layer (310) comprises polytetrafluoroethylene; the second resin layer (330) comprises a polyether block polyamide resin; the metal spring layer (320) comprises a spring wound between the second plastic layer (310) and the second resin layer (330);
wherein the thickness of the second plastic layer (310) is 0.05 mm-0.1 mm; the width of the spring wire in the metal spring layer (320) is 0.15-0.35 mm, and the thickness of the spring wire is 0.03-0.15 mm, wherein the width of the spring wire is less than or equal to 5 times the thickness of the spring wire; the thickness of the second resin layer (330) is 0.03 mm-0.1 mm.
6. A bendable reducing composite pipe according to any of claims 1-3, wherein the composite pipe further comprises a tip section (400), the tip section (400) being arranged at the end of the bendable section (300);
an outer side wall of one end of the tip section (400) facing away from the bendable section (300) is provided with a chamfer (430).
7. The bendable reducing composite pipe according to claim 6, wherein the tip section (400) comprises, in order from inside to outside, a third plastic layer (410) and a third resin layer (420);
the third plastic layer (410) comprises polytetrafluoroethylene; the third resin layer (420) includes a polyether block polyamide resin and a developer.
8. A method for manufacturing a bendable reducing composite pipe, which is characterized in that the manufacturing method is used for manufacturing the bendable reducing composite pipe according to any one of claims 1-7; the manufacturing method comprises the following steps:
sleeving a first plastic pipe on a first section of the mandrel mould (500), sleeving a second plastic pipe on a second section of the mandrel mould (500); wherein the first section of the mandrel mould (500) and the straight section (100) of the composite tube are mutually adapted, and the second section of the mandrel mould (500) and the bendable section (300) of the composite tube are mutually adapted; wherein the first plastic tube and the second plastic tube both comprise polytetrafluoroethylene;
penetrating a support framework (210) into a third section of the mandrel die (500), and aligning two ends of the support framework (210) with the first section and the second section respectively; wherein the third section of the mandrel mould (500) and the transition section (200) of the composite pipe are mutually adapted;
sleeving the outer side walls of the first plastic pipe, the second plastic pipe and the supporting framework (210) with resin pipes; wherein the resin tube comprises a polyether block polyamide resin;
and carrying out thermal compounding on the resin tube.
9. The method for manufacturing a bendable reducing composite pipe according to claim 8, wherein after the step of threading the support frame (210) through the third section of the mandrel mold (500) and aligning the two ends of the support frame (210) with the first section and the second section, respectively, the method further comprises:
a metal braid (120) is formed by braiding metal braid wires between the first plastic tube and the resin tube, and a metal spring layer (320) is formed by winding spring wires between the second plastic tube and the resin tube.
10. The method of manufacturing a bendable reducing composite pipe according to claim 9, wherein the step of thermally compounding the resin pipe is preceded by:
and the outer side wall of the resin pipe is sleeved with a fluorinated ethylene propylene heat shrinkage pipe, and the inner diameter of the fluorinated ethylene propylene heat shrinkage pipe is 0.2-0.3 mm larger than the diameter of each section.
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN215130906U (en) * | 2021-06-17 | 2021-12-14 | 上海臻亿医疗科技有限公司 | Anchoring device, replacement device and replacement system for heart valve |
CN116058920A (en) * | 2021-11-03 | 2023-05-05 | 尼尔拉维有限公司 | Super-bore catheter with braid-supported flared ends |
CN116570401A (en) * | 2022-12-01 | 2023-08-11 | 上海微创心通医疗科技有限公司 | Conveying assembly and conveying system |
CN116726345A (en) * | 2023-06-16 | 2023-09-12 | 东莞市正生瑞生物医学科技有限公司 | Ureter guiding sheath tube |
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Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN215130906U (en) * | 2021-06-17 | 2021-12-14 | 上海臻亿医疗科技有限公司 | Anchoring device, replacement device and replacement system for heart valve |
CN116058920A (en) * | 2021-11-03 | 2023-05-05 | 尼尔拉维有限公司 | Super-bore catheter with braid-supported flared ends |
CN116570401A (en) * | 2022-12-01 | 2023-08-11 | 上海微创心通医疗科技有限公司 | Conveying assembly and conveying system |
CN116726345A (en) * | 2023-06-16 | 2023-09-12 | 东莞市正生瑞生物医学科技有限公司 | Ureter guiding sheath tube |
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