CN112494784A - Vascular interventional radiography guide wire and preparation method thereof - Google Patents
Vascular interventional radiography guide wire and preparation method thereof Download PDFInfo
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- CN112494784A CN112494784A CN202011421446.3A CN202011421446A CN112494784A CN 112494784 A CN112494784 A CN 112494784A CN 202011421446 A CN202011421446 A CN 202011421446A CN 112494784 A CN112494784 A CN 112494784A
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- metal core
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09108—Methods for making a guide wire
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Abstract
The invention discloses a blood vessel intervention contrast guide wire and a preparation method thereof, wherein the contrast guide wire comprises: the internal strong developing metal core, the head end internal spring ring sleeve, the external far-end spring ring sheath, the external near-end polymer sheath, and the surface of the guide wire is coated with a hydrophilic coating. The end of the contrast guide wire provided by the application is preformed into a J-shaped elbow, so that the contrast guide wire is not easy to enter a branch vessel, and the end of the guide wire head can be effectively prevented from damaging the inner wall of the vessel; the J-shaped elbow can adjust the head end bending type when the external spring ring sheath at the far end is subjected to axial extrusion stress until the J-shaped elbow is adjusted to be a straight type, so that the radiography guide wire enters a matching instrument conveniently; the far-end external spring ring sheath is designed to improve the tactile feedback of the operator; the design of the spring ring sleeve inside the head end improves the torque transmission and safety of the guide wire, so that the head end of the contrast guide wire cannot be wound; meanwhile, the hydrophilic coating on the surface of the contrast guide wire improves the lubricity of the contrast guide wire, so that the contrast guide wire can easily reach a target part in a blood vessel.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an angiographic guide wire for vascular intervention and a preparation method thereof.
Background
Coronary artery disease is a common clinical problem in the field of coronary heart disease interventional therapy, and interventional diagnosis and treatment by guide wire conveying and matching with instruments are one of the rapidly developed treatment modes at present.
The main contrast guide wires in the market at present are the following two types:
the first is that the core of the guide wire is nickel-titanium alloy, the outer layer of the guide wire is a polymer sheath, the bending shape of the head end of the guide wire is J-shaped, the surface of the guide wire is provided with a hydrophilic coating, and when the guide wire is clinically applied, the head end structure of the guide wire is designed into an integrated mode of the polymer and the core, when the guide wire enters a sheath tube, a radiography catheter or other matched instruments, the guide wire guide device is needed, the operation is inconvenient, and the operation time is prolonged.
The second is that the guide wire core is stainless steel, the guide wire skin is the spring ring sheath, the guide wire surface is the hydrophobic coating of PTFE, the curved type of guide wire head end is the J type curve, when clinical application, the outer spring ring of guide wire and the hydrophobic coating design of surperficial PTFE make the guide wire arrive at intravascular target site or carry other cooperation apparatus when frictional resistance relatively great, the guide wire lubricity is not enough, the controllability is relatively poor, in addition because whole guide wire skin is wrapped up by the spring ring sheath, and there is the clearance of certain width between the spring wire footpath, the guide wire gets into vascular content and easily forms complication such as thrombus.
In summary, those skilled in the art need to solve the above problems, how to provide a method for facilitating the contrast guide wire to enter into the sheath, or the contrast catheter, or other cooperating devices, and simultaneously improving the smoothness of the contrast guide wire in reaching the lesion.
Disclosure of Invention
The invention aims to provide an angiography guide wire for vascular intervention and a preparation method thereof, wherein the angiography guide wire is convenient to enter a sheath, an angiography catheter and other matched instruments, is not easy to damage the inner wall of a blood vessel and is easy to reach a target part in the blood vessel; the contrast guide wire has good tactile feedback, controllability, trafficability, lubricity and safety, and has good comprehensive performance.
In order to achieve the above purpose, the invention provides the following technical scheme:
in a first aspect, an angiographic guidewire for interventional angiography includes a strongly visualized metal core having a J-bend at its distal end; the periphery of the J-shaped elbow of the metal core is sleeved with an internal spring ring sleeve; the far end of the metal core is sleeved with an external spring ring sheath; the proximal end of the metal core is sleeved with a polymer sheath, and the polymer sheath extends from the proximal end of the metal core to the proximal end of the external spring coil sheath; the surface of the contrast guide wire is coated with a hydrophilic coating.
In some embodiments of the present application, the surfaces of the polymer jacket and the outer coil jacket are coated with the hydrophilic coating.
In some embodiments of the present application, the inner spring coil sleeve and the outer spring coil sheath are respectively fixedly connected to the metal core by welding or bonding.
In some embodiments of the present application, the hydrophilic coating is a polyvinylpyrrolidone coating, or a polyethylene oxide coating, or a transparent acid ester acrylic coating, or a polymethyl vinyl ether maleic anhydride coating.
In some embodiments of the present application, a polymer layer is disposed between the hydrophilic coating and the metal core.
In some embodiments of the present application, the contrast guidewire polymer layer is a polyurethane polymer layer, a nylon polymer layer, a polylactic acid polymer layer, or a polyetheretherketone polymer layer.
In some embodiments of the present application, the metal core with the J-bend comprises an equal-diameter section, a variable-diameter section, a bent section and a straight section which are sequentially distributed along the length direction of the metal core, wherein the diameter of the variable-diameter section is gradually reduced from the proximal end to the distal end of the metal core. The surfaces of the variable diameter section, the bending section and the straight section of the metal core are coated with gold, or platinum-tungsten alloy, or platinum-nickel alloy, or medical precious metal plating. The head end of the metal core and the spring ring sleeve in the guide wire head end form a composite developing section.
In some embodiments of the present application, the cross-sectional shape of the straight section is circular.
In a second aspect, the present application provides a method for preparing an angiographic guidewire for vascular intervention according to the first aspect, comprising:
preparing a linear metal core by machining numerical control grinding and combining with the technology of physical grinding, or electrolytic polishing, or chemical etching;
sleeving the distal end head of the metal core in the inner cavity of the mold by using a cold set bending mold to form a J-shaped elbow at the distal end head of the metal core, and carrying out a heat treatment process on the mold with the J-shaped elbow and the distal end head of the metal core to shape the J-shaped elbow;
the surface of the variable diameter section, the bending section and the straight section of the metal core is coated with gold, platinum-tungsten alloy, platinum-nickel alloy or medical precious metal coating by utilizing a magnetron sputtering technology, an atomization deposition technology, a chemical deposition technology or an electrophoresis technology, so that the far end of the metal core and the internal spring ring sleeve form a composite developing section. Winding by using a spring machine or knitting by using a knitting machine, manufacturing a head-end internal spring ring sleeve pipe and a far-end external spring ring sheath, sleeving and fixing the internal spring ring sleeve pipe on the periphery of the J-shaped elbow, and sleeving and fixing the external spring ring sheath on the far end of the metal core and the periphery of the internal spring ring sleeve pipe;
coating a polymer layer on the proximal end of the metal core by using a rheologic process or an extruder continuous extrusion process and combining a tip forming machine, wherein the polymer layer extends from the proximal end of the metal core to the proximal end of the outer spring coil sheath;
and coating a hydrophilic coating on the surface of the contrast guide wire sheath by one of automatic spraying, dip coating or manual coating.
The invention has the beneficial effects that: the vascular intervention radiography guide wire comprises a metal core with a J-shaped elbow at the distal end; the surface of the reducing section, the bending section and the straight section at the far end of the metal core is coated with gold, or platinum-tungsten alloy, or platinum-nickel alloy, or medical precious metal coating, so that the head end of the metal core and the spring ring sleeve in the head end of the guide wire form a composite developing section. The periphery of the J-shaped elbow of the metal core is sleeved with an internal spring ring sleeve; the far end of the metal core is sleeved with an external spring ring sheath; the proximal end of the metal core is sleeved with a polymer sheath, and the polymer sheath extends from the proximal end of the metal core to the proximal end of the external spring coil sheath; the surface of the contrast guide wire is coated with a hydrophilic coating.
When the blood vessel intervenes in the contrast guide wire, the J-shaped elbow at the guide wire head end can effectively prevent the guide wire from entering a branch blood vessel and prevent the guide wire head end from damaging the inner wall of the blood vessel. Meanwhile, when the guide wire enters a sheath tube, an angiography catheter or other matched instruments, an operator can apply axial extrusion stress to the proximal end position of the external spring ring sheath at the far end of the guide wire through fingers, so that the bending type of the end of the angiography guide wire can be adjusted until the J-shaped elbow at the end of the guide wire is straightened, and the guide wire end can conveniently enter the instrument matched with the guide wire end, so that the angiography guide wire does not need a guide wire guider during clinical application and is more convenient to use. In addition, an internal micro-spring ring sleeve is sleeved on the J-shaped bent periphery of the head end of the metal core of the radiography guide wire, and the internal micro-spring ring sleeve is designed to enable the head end of the guide wire to form a composite cone structure, so that the connection strength and the support performance of the head end of the guide wire and the torque transmission performance of the far end of the guide wire are improved. Meanwhile, the plating layer at the head end of the metal core and the inner micro-spring snare tube form a composite developing section, so that the head end of the radiography guide wire has a strong developing effect, and the controllability of the guide wire under X-rays is improved. In addition, the hydrophilic coating is coated on the surface of the contrast guide wire, so that the guide wire has high lubricity, the guide wire can quickly pass through an instrument matched with the guide wire and smoothly reach a target part in a blood vessel, and meanwhile, the formation of thrombus in the blood vessel can be effectively avoided.
The intravascular interventional angiography guide wire has good tactile feedback, trafficability, pushing performance, flexibility, superelasticity, lubricity, safety and controllability and excellent comprehensive performance.
Drawings
Fig. 1 is a schematic view of a macro structure of an angiographic guidewire for vascular intervention provided by the present invention;
FIG. 2 is an enlarged partial view of a portion of the distal end A of the contrast guidewire of FIG. 1;
FIG. 3 is a cross-sectional view of the proximal end of the visualization guidewire of FIG. 1 taken along the Z-Z direction;
FIG. 4 is a schematic structural diagram of a linear metal core of a contrast guidewire provided by the present invention;
FIG. 5 is a schematic structural view of a contrast guidewire metal core head provided by the present invention after heat setting;
FIG. 6 is a cross-sectional view of the proximal end of the metal core of FIGS. 4 and 5 taken along the Y-Y direction;
figure 7 is a cross-sectional view of the head end of a metal core taken along the X-X direction in figures 4 and 5;
fig. 8 is a process flow chart of a method for preparing an angiographic guidewire according to the present invention.
The reference numerals in figures 1 to 7 are:
1-metal core, 11-equal diameter section, 12-variable diameter section, 13-bending section and 14-straight section; 2-a polymer jacket; 21-polymer layer, 22-hydrophilic coating; 3-internal spring coil sleeve, 4-external spring coil sheath, 5-internal spring coil sleeve near-end welding spot, 6-external spring coil sheath near-end welding spot, and 7-radiography guide wire head-end welding spot.
Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the present application will be described and illustrated below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments provided in the present application without any inventive step are within the scope of protection of the present application. Moreover, it should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another.
Reference in the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the specification. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of ordinary skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments without conflict.
Unless defined otherwise, technical or scientific terms referred to herein shall have the ordinary meaning as understood by those of ordinary skill in the art to which this application belongs. Reference to "a," "an," "the," and similar words throughout this application are not to be construed as limiting in number, and may refer to the singular or the plural. The present application is directed to the use of the terms "including," "comprising," "having," and any variations thereof, which are intended to cover non-exclusive inclusions; for example, a process, method, system, article, or apparatus that comprises a list of steps or modules (elements) is not limited to the listed steps or elements, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. Reference to "connected," "coupled," and the like in this application is not intended to be limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Reference herein to "a plurality" means greater than or equal to two. "and/or" describes an association relationship of associated objects, meaning that three relationships may exist, for example, "A and/or B" may mean: a exists alone, A and B exist simultaneously, and B exists alone. Reference herein to the terms "first," "second," "third," and the like, are merely to distinguish similar objects and do not denote a particular ordering for the objects.
Referring to fig. 1 to 7, fig. 1 is a schematic view of a macro structure of an angiographic guidewire for vascular intervention according to the present invention; FIG. 2 is an enlarged partial view of a portion of the distal end A of the contrast guidewire of FIG. 1; FIG. 3 is a cross-sectional view of the proximal end of the visualization guidewire of FIG. 1 taken along the Z-Z direction; FIG. 4 is a schematic structural diagram of a linear metal core of a contrast guidewire provided by the present invention; FIG. 5 is a schematic view of a contrast guidewire metal core provided by the present invention after heat setting; FIG. 6 is a cross-sectional view of the proximal end of the metal core of FIGS. 4 and 5 taken along the Y-Y direction; fig. 7 is a cross-sectional view of the head end of the metal core taken along the X-X direction in fig. 4 and 5.
The application provides an angiogram seal wire is intervene to blood vessel, have J type elbow and the strong metal core 1 who develops including the head end, the periphery cover of the J type elbow of metal core head end is equipped with inside spring coil sleeve pipe 3, the periphery cover of the inside spring coil sleeve pipe of metal core distal end and head end is equipped with outside spring coil sheath 4, the near-end periphery cover of metal core 1 is equipped with polymer sheath 2, and extend to the near-end of outside spring coil sheath 4 from the near-end of metal core 1, this angiogram seal wire polymer sheath and outside spring coil sheath surface all coat hydrophilic coating.
Specifically, the contrast guide wire refers to a preformed guide wire with a J-shaped elbow for intravascular interventional diagnosis. The contrast guidewire has a distal end and a proximal end, wherein the distal end refers to the portion of the contrast guidewire distal from the operator and the proximal end refers to the portion of the contrast guidewire proximal to the operator.
The metal core 1 should be made of a material having excellent torque transmission, tracking, support, super-elasticity, durability, fatigue, etc., and providing good support and pushing force for the contrast guidewire. The surface of the metal core 1 should be smooth and clean without defects such as scabs, cracks, burrs, scratches, etc., which could potentially risk the patient. The metal core 1 is made of any one or more of Ni-Ti alloy, stainless steel, cobalt-based alloy, Fe-Mn alloy, Cu-Zn alloy, and Fe-Ni alloy, but of course, other materials having suitable properties may be used to prepare the core 1. Preferably, the metal core 1 is made of a Ni — Ti alloy in a high elastic state.
The metal core 1 can be manufactured by using a method or a technique such as physical grinding, or electrolytic polishing, or chemical etching, and the physical grinding method is preferred. When the metal core 1 is made of Ni-Ti alloy, the J-shaped elbow at the head end of the metal core 1 can be subjected to heat setting by utilizing a cold set bending die and controlling a heat treatment process. For example, the temperature of the heat treatment is controlled to be 400-800 ℃, heat preservation is carried out for a specified time, and a proper cooling mode is selected, so that the head end of the metal core 1 obtains a J-shaped elbow with a proper size and the softness of the head end.
The surfaces of the variable diameter section 12, the bending section 13 and the straight section 14 of the metal core are coated with gold, platinum-tungsten alloy, platinum-nickel alloy or medical precious metal coatings by magnetron sputtering, atomization deposition, chemical deposition or electrophoresis technology, so that the far end of the metal core and the spring ring sleeve 3 in the head end of the guide wire form a composite developing section.
The metal core 1 comprises an equal-diameter section 11, a variable-diameter section 12, a bent section 13 and a straight section 14, wherein the four sections sequentially extend from a near end to a far end along the length direction of the metal core 1, the bent section 13 is in a smooth curve shape on a macroscopic scale, the equal-diameter section 11 and the variable-diameter section 12 are coaxially distributed, and the variable-diameter section 12, the bent section 13 and the straight section 14 form a J-shaped elbow part at the head end of the metal core.
The spring ring sleeve 3 in the radiography guide wire head end and the head end of the metal core 1 form a composite cone structure, and the structure can improve the connection strength and the support property of the guide wire head end and the torque transmission performance of the guide wire far end; the contrast guidewire distal end external spring sheath 4 may improve the tactile feedback capability of the guidewire. The head end internal spring ring sleeve 3 and the distal end external spring ring sheath 4 can be made of stainless steel wire, stainless steel wire with a PTFE pre-coating layer, platinum nickel wire, platinum tungsten wire, gold wire, medical noble metal alloy wire and the like which are wound by a spring machine or woven by a weaving machine. In the process of assembling the head end internal spring coil sleeve 3, the far end external spring coil sheath 4 and the metal core 1, the far end of the head end internal spring coil sleeve 3 is connected with the far end of the metal core 1, and the near end is coaxially connected with the metal core 1; the distal outer coil sheath 4 has a distal end connected to the metal core 1, the distal end of the inner coil sleeve 3, and a proximal end coaxially connected to the metal core 1. More specifically, the distal end of the head-end internal spring coil sleeve 3 is connected to the distal end of the straight section 14 of the metal core 1 and the proximal end is connected to the tapered section 12 of the metal core 1; the distal end of the distal outer coil sheath 4 is connected to the distal end of the straight section 14 of the metal core 1 and the distal end of the inner coil sleeve 3, and the proximal end can be connected to the tapered section 12 of the metal core 1. if the tapered section 12 is shorter, the proximal end of the coil sheath 4 can also be connected to the constant diameter section 11 of the metal core 1. The connection of the head end inner spring coil sleeve 3 and the distal end outer spring coil sheath 4 to the metal core 1 may be fixed by any one of the connection methods of brazing, laser welding, resistance welding, ultrasonic welding, bonding, and the like. Preferably, the proximal end welding point 5 of the internal spring ring sleeve 3, the proximal end welding point 6 of the external spring ring sheath 4 and the radiography guide wire head end welding point 7 are mutually connected and fixed in a brazing or laser welding mode.
The polymer sheath 2 may cover all or part of the surface of the contrast guidewire. A polymer layer 21 is sleeved between a hydrophilic coating 22 on the surface of the contrast guide wire and the metal core 1, and the polymer layer is a polyurethane high polymer layer, a nylon high polymer layer, a polylactic acid high polymer layer or a polyether-ether-ketone high polymer layer. The hydrophilic coating 22 is a polyvinylpyrrolidone coating, or a polyethylene oxide coating, or a transparent acid ester acrylic coating, or a polymethyl vinyl ether maleic anhydride coating. The hydrophilic coating 22 can improve the smoothness and lubricity of the surface of the contrast guide wire, and the mechanism is that the hydrophilic coating 22 absorbs water molecules to form a gel-like film on the surface of the contrast guide wire, and the film can reduce the passing resistance of the contrast guide wire in blood vessels and related matched instruments, so that the contrast guide wire has good lubricity and tracking performance, is easy to push and effectively improves the passing capacity of the contrast guide wire.
The utility model provides an radiography seal wire head end preforming is J type elbow, can effectively avoid the seal wire to get into branch blood vessel, avoid seal wire head end damage blood vessel inner wall, and simultaneously, get into the sheath pipe at the radiography seal wire, the radiography pipe, or when other cooperation apparatus, the art person can exert axial extrusion stress to the near-end position of seal wire distal end outside spring ring sheath 4 through the finger, can adjust the curved type of radiography seal wire head end, the J type elbow of seal wire head end is straightened up, thereby make the convenient entering of seal wire head end and matched with apparatus with it, consequently, this radiography seal wire does not need seal wire guide when clinical application, and it is more convenient to use. In addition, the J-shaped bent periphery of the head end of the radiography guide wire metal core 1 is sleeved with an internal spring ring sleeve 3, the internal spring ring sleeve is designed to enable the head end of the radiography guide wire to form a composite cone structure, and the connection strength and the support performance of the guide wire head end and the torque transmission performance of the guide wire far end are improved. In addition, the hydrophilic coating 22 is coated on the surface of the contrast guide wire, so that the guide wire has high lubricity, the guide wire can quickly pass through an instrument matched with the guide wire and smoothly reach a target part in a blood vessel, and meanwhile, the formation of thrombus in the blood vessel can be effectively avoided.
Optionally, in practical application, the specific size of the contrast guidewire needs to be designed according to practical requirements, and the following size specifications are preferably adopted in this embodiment: the far-end preforming of the contrast seal wire is a J-shaped elbow, the diameter D of the J-shaped elbow is 2-10 mm, the diameter D of the contrast seal wire is 0.010-0.038 ", and the total length of the contrast seal wire is 50-450 cm. The thickness of the plating layer at the far end of the metal core is 0.0002-0.002 ". In the spring ring sleeve 3 in the head end, the wire diameter of the spring ring is 0.001-0.01 ', the outer diameter of the spring ring is 0.008-0.038', and the length of the spring is 1-80 mm; in the distal external spring coil sheath 4, the wire diameter of the spring coil is 0.0015 "to 0.01", the outer diameter of the spring coil is 0.01 "to 0.038", and the length of the spring is 1 to 450 cm.
Furthermore, in order to optimize the use effect of the metal core 1, in a specific structural embodiment of the metal core reducer 12 provided by the present application, the diameter of the reducer 12 decreases from the proximal end to the distal end, so that the distal end of the contrast guidewire has good flexibility and can more easily pass through tortuous blood vessels. The profile shape of the reducer section 12 may be any one of a conical shape, a parabolic shape, and a streamline shape.
Furthermore, in order to optimize the use effect of the metal core 1, the variable diameter section 12, the bent section 13 and the straight section 14 of the metal core provided by the application are coated with gold, platinum-tungsten alloy, platinum-nickel alloy or medical precious metal coatings on the surface of the head end of the metal core by magnetron sputtering technology, atomization deposition technology, chemical deposition technology or electrophoresis technology. The head end of the metal core and the spring ring sleeve 3 in the guide wire head end form a composite developing section, so that the radiography guide wire head end has strong developing effect under X-ray.
In the embodiment of the specific structure of the head end straight section 14 of the metal core provided by the present application, the head end straight section 14 and the equal diameter section 11 are substantially distributed in parallel in the axial direction, and the cross section of the head end straight section 14 is circular. More specifically, the circular core wire of the flat end section 14 of the metal core head after the machining numerical control grinding is processed to the required size by methods or technologies such as physical grinding, electrolytic polishing, chemical etching and the like, and the size can effectively adjust the flexibility and the elastic rate of the head end of the contrast guide wire.
Optionally, to optimize the performance of the contrast guidewire, the present application provides an embodiment wherein the surface of the distal outer coil sheath 4 is provided with a PTFE coating, or a hydrophilic coating, or a silicone oil coating. Specifically, the PTFE coating, or the hydrophilic coating, or the silicone oil coating disposed on the surface of the distal external spring coil sheath 4 extends from the proximal end of the distal external spring coil sheath 4 to the distal end of the external spring coil sheath 4, thereby further reducing the push resistance of the contrast guidewire. In actual processing, when the surface of the distal outer coil sheath 4 is coated with a hydrophilic coating, it is preferable that the hydrophilic coating applied to the surface of the distal outer coil sheath 4 be consistent with the material of the hydrophilic coating 22 applied to the surface of the contrast guidewire, thereby reducing the difficulty of applying the hydrophilic coating.
Optionally, in order to optimize the performance of the contrast guidewire, the present application provides an embodiment in which the hydrophilic coating 22 on the surface of the contrast guidewire and the metal core 1 are coated with a polymer layer 21. More specifically, the polymer layer 21 is disposed on the surface of the metal core 1 in the region where the outer coil sheath 4 is not disposed, i.e., the polymer layer 21 extends from the proximal end of the metal core 1 to the proximal end of the outer coil sheath 4, and the polymer layer 21 and the hydrophilic coating 22 on the surface of the contrast guidewire form a polymer composite cladding, i.e., the polymer sheath 2. In actual processing, the polymer layer 21 may be a polyurethane polymer layer, a nylon polymer layer, a polylactic acid polymer layer, or a polyether ether ketone polymer layer.
Referring to fig. 8, fig. 8 is a process flow chart of a method for processing an angiographic guidewire according to the present invention. The application also provides a processing method for manufacturing any one of the contrast guide wires, which comprises the following steps:
and step S1, preparing the linear metal core 1 by machining and numerical control grinding. Specifically, the metal core 1 with the equal-diameter section 11, the variable-diameter section 12 and the head-end straight section 14 is prepared through machining and numerical control grinding. If the profile of the reducer section 12 is a conical structure, the reducer section 12 needs to be machined and numerically controlled to be ground, so that the diameter of the reducer section is gradually reduced. If the head end of the metal core 1 is required to be softer, the machined and numerically controlled ground straight section 14 of the head end of the metal core needs to be processed to a required size by methods or technologies such as physical grinding, electrolytic polishing, chemical etching and the like, and finally, the whole metal core 1 is processed.
And step S2, penetrating the head end of the metal core 1 into the inner cavity of the J-shaped bending die by using the cold forming die to form a J-shaped elbow at the head end of the metal core 1, and carrying out a proper heat treatment process on the J-shaped elbow to form the J-shaped elbow at the head end of the metal core, namely completing the heat forming of the J-shaped elbow at the head end of the metal core 1 by combining the head end of the metal core 1 with the proper heat treatment process through the cold forming die.
Step S3, coating gold, platinum-tungsten alloy, platinum-nickel alloy, or medical precious metal plating on the surfaces of the distal end diameter-changing section 12, the bending section 13, and the straight section 14 of the metal core 1 by magnetron sputtering technology, atomization deposition technology, chemical deposition technology, or electrophoresis technology, so that the distal end of the metal core and the inner spring ring sleeve 3 at the guide wire head end form a composite developing section.
Step S4, the head-end internal spring coil sleeve 3 and the distal-end external spring coil sheath 4 are manufactured by coiling with a spring machine or braiding with a braiding machine. The head end internal spring ring sleeve 3 is sleeved and fixed on the periphery of the J-shaped elbow at the head end of the metal core, and the far end external spring ring sheath 4 is sleeved and fixed on the periphery of the far end of the metal core and the head end internal spring ring sleeve. Specifically, stainless steel wires, platinum-nickel wires, platinum-tungsten wires, gold wires or medical noble metal alloy wires are wound by a spring machine or woven by a weaving machine to manufacture the internal spring ring sleeve 3; and (3) winding the stainless steel round wire, the stainless steel flat wire or the stainless steel wire pre-coated with the PTFE coating by a spring machine or weaving by a weaving machine to manufacture the external spring ring sheath 4. The inner coil sleeve 3 and distal outer coil sheath 4 are then fixedly attached to the distal end of the metal core 1. Wherein, the far end of the spring ring sleeve 3 in the head end is connected with the far end of the metal core 1, and the near end metal core 1 is coaxially connected; the distal end of the distal outer spring coil sheath 4 is connected to the distal ends of the metal core 1 and the inner spring coil sleeve 3, and the proximal end is coaxially connected to the metal core 1, and then is fixedly connected thereto by soldering, or laser welding, or bonding.
Step S5, the proximal end of the metal core 1 is covered with the polymer layer 21. Specifically, a polymer layer 21 is coated on the proximal end of the core wire 1 and extends from the proximal end of the metal core 1 to the proximal end of the distal outer coil sheath 4 using a rheo-logical process, or an extruder continuous extrusion process, in conjunction with a tip former.
Step S6, the hydrophilic coating 22 is coated on the surface of the contrast guide wire. Specifically, the hydrophilic coating 22 can be applied on the surface of the contrast guidewire by automatic spraying, or by dip coating, or by manual coating. Optionally, the hydrophilic coating 22 may also be applied to the surface of the distal outer coil sheath 4 simultaneously during this process.
The preparation method of the vessel intervention contrast guide wire is simple to operate and easy to realize, and the bent structure of the head end of the contrast guide wire can be adjusted according to clinical requirements without influencing the overall design of the contrast guide wire. The prepared contrast guide wire should be checked whether each part is connected and fastened, whether the appearance and the size of the guide wire meet the design requirements, whether the coating is complete, whether a falling part exists, and the like.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts in the embodiments are referred to each other.
The vascular interventional angiography guide wire and the preparation method thereof provided by the invention are described in detail above. The principles and embodiments of the present invention are described in detail herein using specific examples, which are presented only to assist in understanding the method and its core concepts of the present invention. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.
Claims (10)
1. An angiographic guide wire for vascular intervention is characterized by comprising a metal core (1) which has a J-shaped bend at the distal end and is used for strong visualization; the periphery of the J-shaped elbow of the metal core is sleeved with an internal spring ring sleeve (3); the far end of the metal core is sleeved with an external spring ring sheath (4); the proximal end of the metal core is sleeved with a polymer sheath (2) which extends from the proximal end of the metal core to the proximal end of the external spring coil sheath; the surface of the contrast guide wire is coated with a hydrophilic coating (22).
2. The angiographic guidewire of claim 1, wherein the surfaces of the polymer sheath (2) and the external coil sheath (4) are coated with the hydrophilic coating (22).
3. The angiographic guidewire according to claim 1, characterized by the fact that the inner coil sleeve (3) and the outer coil sheath (4) are fixed to the metal core (1) by welding or gluing, respectively.
4. The angiographic guidewire according to claim 1, wherein the hydrophilic coating (22) is a polyvinylpyrrolidone coating, or a polyethylene oxide coating, or a transparent acid ester acrylic coating, or a polymethyl vinyl ether maleic anhydride coating.
5. The angiographic guidewire according to claim 1, characterized by a polymer layer (21) between the hydrophilic coating (22) and the metallic core (1).
6. The angiographic guidewire according to claim 5, wherein said angiographic guidewire polymer layer (21) is a polyurethane polymer layer, a nylon polymer layer, a polylactic acid polymer layer, or a polyetheretherketone polymer layer.
7. The angiographic guidewire according to any one of claims 1 to 6, wherein the metal core (1) with J-bend comprises an equal diameter section (11), a variable diameter section (12), a bending section (13) and a straight section (14) distributed in sequence along the length direction of the metal core, and the diameter of the variable diameter section (12) is gradually reduced from the proximal end to the distal end of the metal core.
8. The angiographic guidewire according to claim 7, wherein the cross-sectional shape of the straight section (14) is circular.
9. The angiographic guidewire according to claim 7, wherein the surface of the reducing section (12), the bending section (13) and the straight section (14) of the metal core (1) is coated with gold, platinum-tungsten alloy, platinum-nickel alloy or medical precious metal, so that the distal end of the metal core and the internal spring coil sleeve (3) form a composite visualization section.
10. A method for preparing an angiographic guidewire for vascular intervention according to any of claims 1 to 9, comprising:
preparing a linear metal core (1) by machining numerical control grinding and combining the technologies of physical grinding, electrolytic polishing or chemical etching;
sleeving the distal end head of the metal core (1) in the inner cavity of the mold by using a cold set bending mold, forming a J-shaped elbow at the distal end head of the metal core, and carrying out a heat treatment process on the mold with the J-shaped elbow and the distal end head of the metal core to shape the J-shaped elbow;
gold, platinum-tungsten alloy, platinum-nickel alloy and medical precious metal coatings are coated on the surfaces of the reducing section (12), the bending section (13) and the straight section (14) of the metal core (1) through magnetron sputtering, atomization deposition, chemical deposition or electrophoresis technology, so that the far end of the metal core and the internal spring ring sleeve (3) form a composite developing section;
utilizing a spring machine to wind or weave by a weaving machine to manufacture a head-end internal spring ring sleeve (3) and a far-end external spring ring sheath (4), sleeving and fixing the internal spring ring sleeve (3) on the periphery of the J-shaped elbow, and sleeving and fixing the external spring ring sheath (4) on the far end of the metal core and the periphery of the internal spring ring sleeve;
coating a polymer layer (21) on the proximal end of the metal core (1) by using a rheologic process or an extruder continuous extrusion process and combining a tip forming machine, wherein the polymer layer extends from the proximal end of the metal core to the proximal end of the external spring coil sheath;
and coating a hydrophilic coating (22) on the surface of the contrast guide wire sheath by one of automatic spraying, dip coating or manual coating.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011421446.3A CN112494784A (en) | 2020-12-08 | 2020-12-08 | Vascular interventional radiography guide wire and preparation method thereof |
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| CN202011421446.3A CN112494784A (en) | 2020-12-08 | 2020-12-08 | Vascular interventional radiography guide wire and preparation method thereof |
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| CN113171542A (en) * | 2021-04-28 | 2021-07-27 | 深圳市顺美医疗股份有限公司 | Micro-guide wire composite core wire preparation device and preparation method thereof |
| CN113893443A (en) * | 2021-10-25 | 2022-01-07 | 深圳麦普奇医疗科技有限公司 | Micro guide wire with nickel-titanium hose |
| CN115229612A (en) * | 2022-07-14 | 2022-10-25 | 惠州市顺美医疗科技有限公司 | Guide wire and welding spot grinding method thereof |
| CN116617545A (en) * | 2023-06-09 | 2023-08-22 | 株洲茂物医疗科技有限公司 | Method for manufacturing guide wire and guide wire |
| CN116850430A (en) * | 2023-09-05 | 2023-10-10 | 易生科技(北京)有限公司 | Guide wire |
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| CN116850430A (en) * | 2023-09-05 | 2023-10-10 | 易生科技(北京)有限公司 | Guide wire |
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