Guide wire with flat wire tube

Abstract

The guide wire comprises a core wire, a developing spring, the flat wire tube and an outer coating, the developing spring and the flat wire tube are arranged on the outer portion of the core wire, the outer coating is arranged on the flat wire tube, the cross section of the flat wire tube is in the shape of one of an oval, a triangle and a hexagon, the contact area between the guide wire and a catheter is reduced, and the service life of the guide wire is prolonged. A gap between the guide wire and the guide pipe can be reserved, the blocking phenomenon is reduced, the occurrence probability of the windowsill effect is reduced, and the windowsill effect caused by large diameter difference between the guide wire and the guide pipe in the use process in the prior art is solved; the cross sections of the flat wire units are oval, and deflection angles exist between long-axis straight lines of the cross sections of the adjacent flat wire units in the axial direction, so that the catheter can advance in the deflection direction of the flat wire tube, the contact area between the guide wire and the catheter is reduced, and meanwhile the situation that the guide wire and the axis of the catheter differ too much is avoided; therefore, the catheter and the guide wire have a stable centering relation, and the jamming phenomenon in the using process is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a medical device for inputting a medium into or onto a human body, and in particular to a guide wire with a flat wire tube. Background Art

[0002] The sill effect is a common phenomenon in vascular interventional procedures, especially when using catheters and guidewires. It refers to the large gap between the catheter and the guidewire due to the large diameter difference between the two. This gap will produce a "window sill"-like blocking effect in curved anatomical structures or branched vessels during intravascular navigation, making it difficult for the catheter to pass smoothly through these complex vascular sites.

[0003] When the guidewire and catheter pass through the curved part or branch of the blood vessel together, the catheter will get stuck in these complex structures due to the "window sill effect" and cannot be smoothly advanced. This is because the outer diameter of the catheter is relatively large, and the flexibility of the guidewire is not enough to drive the catheter through the narrow or curved blood vessel segment. The windowsill effect will cause the operation time to be prolonged, increase the difficulty of operation, and even lead to surgical failure. Doctors need to repeatedly adjust the position of the guidewire and catheter, or replace catheters and guidewires of different specifications, which not only increases the risk of surgery, but also causes additional trauma to patients.

[0004] Therefore, it is necessary to improve the guidewire used in daily life to solve the above-mentioned defects. Summary of the invention

[0005] The present invention overcomes the shortcomings of the prior art and provides a guide wire with a flat wire tube, aiming to solve the defect of the window sill effect caused by the large diameter difference between the guide wire and the catheter during use in the prior art. To achieve the above purpose, the technical solution adopted by the present invention is: a guide wire with a flat wire tube, comprising: a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube:

[0006] The core wire comprises: a core wire head and a core wire trunk fixedly connected to the core wire head, the core wire head is coaxially arranged with the developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire trunk is fixedly connected to the flat wire tube, and one end away from the core wire trunk is fixedly connected to the core wire head;

[0007] The flat wire tube, the core wire trunk and the outer coating are coaxially arranged, the length of the flat wire tube is consistent with the length of the core wire trunk and the length of the outer coating, the flat wire tube includes a plurality of the flat wire units, the cross-sectional external contour of each of the flat wire units is consistent and is one of an ellipse, a triangle and a hexagon, and the plurality of the flat wire units are connected in sequence;

[0008] The outer coating is made of one of modified TPU and PTFE, and the guide wire head is provided with a hydrophilic coating.

[0009] In a preferred embodiment of the present invention, the core wire material is one of nickel-titanium alloy, stainless steel and nickel-tanium alloy.

[0010] In a preferred embodiment of the present invention, the developing spring material is a metal with a developing function, and the metal with a developing function is one of a platinum-nickel alloy, a platinum-tungsten alloy and a platinum-iridium alloy. The preparation process is to form a coil by winding the metal with a developing function, and the developing spring structure is one of a single-strand spring and a double-strand spring.

[0011] In a preferred embodiment of the present invention, the end of the core wire head away from the core wire body is spherical in shape.

[0012] In a preferred embodiment of the present invention, the cross-sectional profile of the flat wire unit is elliptical, there is a deflection angle between the major axis lines of the cross-sectional views of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent.

[0013] In a preferred embodiment of the present invention, the deflection angle of adjacent flat wire units is 360° / N, where N is a factor of 360 and is an even number greater than 2.

[0014] In a preferred embodiment of the present invention, when the total deflection angle of a plurality of consecutive flat wire units along the axial direction reaches 360°, the total lengths of the plurality of consecutive flat wire units are consistent.

[0015] In a preferred embodiment of the present invention, the ratio of the major axis to the minor axis of the flat wire unit is 3-2:1, the ratio of the minor axis to the core wire radius is 0.75-1.25:1, and the core wire radius size ranges from 0.01 to 0.2 mm.

[0016] In a preferred embodiment of the present invention, the outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of major to minor axes, and the ratio of the major axis of the outer contour of the cross section of the outer coating to the major axis of the outer contour of the flat wire unit is 1.1-1.3:1.

[0017] In a preferred embodiment of the present invention, a transition portion is provided between each of the adjacent flat wire units, and the transition portion is used to smooth the adjacent flat wire units.

[0018] The present invention solves the defects existing in the background technology and has the following beneficial effects:

[0019] (1) The present invention provides a guide wire with a flat wire tube, a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube, wherein the cross-sectional shape of the flat wire tube is one of an ellipse, a triangle and a hexagon, thereby reducing the contact area between the guide wire and the catheter. Compared with the guide wire in the prior art, the present invention can reduce the gap between the guide wire and the catheter, reduce the jamming phenomenon, and reduce the probability of the windowsill effect, thereby solving the defect of the windowsill effect caused by the large diameter difference between the guide wire and the catheter during use in the prior art.

[0020] (2) In the present invention, the core wire material is one of nickel-titanium alloy and stainless steel. Nickel-titanium alloy has significant superelasticity and shape memory effect, and the high strength and rigidity of stainless steel can withstand greater tension and pressure. Compared with the existing technology, it can provide reliable structural support and navigation accuracy. This helps to more accurately locate and operate.

[0021] (3) In the present invention, there is a deflection angle between the long axis straight lines of the cross-sections of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. Compared with the prior art, by setting the same deflection angle and consistent deflection direction, a tighter and more orderly connection can be formed between adjacent flat wire units, which helps to disperse external stress and improve the strength of the entire flat wire tube structure.

[0022] (4) In the present invention, the deflection angle of adjacent flat wire units is 360° / N, where N is a factor of 360 and is an even number greater than 2. The regular deflection angle makes the inner wall of the flat wire tube smoother than the prior art, reduces the friction between the flat wire tube and the guide wire, helps the guide wire to pass through the catheter more smoothly, and reduces the risk of jamming and damage. The deflection structure of the flat wire unit can provide better guidance for the guide wire.

[0023] (5) In the present invention, the cross-section of the flat wire unit is elliptical, and there is a deflection angle between the long axis straight lines of the cross-sections of adjacent flat wire units along the axial direction, which enables the catheter to move forward along the deflection direction of the flat wire tube. Compared with the prior art, the contact area between the guide wire and the catheter is reduced while preventing the guide wire from deviating too much from the axis of the catheter, so that the catheter and the guide wire have a stable centering relationship, reducing the jamming phenomenon during use.

[0024] (6) In the present invention, a transition portion is provided between each adjacent flat wire unit, and the transition portion is used to smooth the adjacent flat wire units so that a torsion portion exists between the adjacent flat wire units, which can provide rotational force to the catheter. Compared with the prior art, the guide wire can be rotated when the catheter is stuck, so that the catheter opening coincides with the guide wire transition portion, and the catheter can be reset during the guide wire rotation process to ensure the reset of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

[0026] Figure 1 is a side view of a preferred embodiment of the present invention;

[0027] Figure 2 is a perspective view of a preferred embodiment of the present invention;

[0028] Figure 3 is a cross-sectional view of a flat wire tube of a preferred embodiment of the present invention;

[0029] In the figure: 100, core wire; 200, developing spring; 300, flat wire tube; 400, outer coating. DETAILED DESCRIPTION

[0030] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0031] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein. Therefore, the protection scope of the present invention is not limited to the specific embodiments disclosed below.

[0032] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the invention, unless otherwise specified, "multiple" means two or more.

[0033] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood by specific circumstances.

[0034] like Figure 1 and Figure 2 As shown, a guide wire with a flat wire tube includes: a core wire 100, a developing spring 200 and a flat wire tube 300 respectively arranged on the outside of the core wire 100.

[0035] The core wire 100 includes: a core wire 100 head, and a core wire 100 trunk fixedly connected to the core wire 100 head. The core wire 100 head is coaxially arranged with a developing spring 200. The developing spring 200 and the core wire 100 head have the same axial dimensions. One end of the developing spring 200 close to the core wire 100 trunk is fixedly connected to the flat wire tube 300, and one end away from the core wire 100 trunk is fixedly connected to the core wire 100 head. The coaxial arrangement of the core wire 100 head and the developing spring 200 ensures the stability of the entire guide wire in the axial direction. This coaxial design reduces the distortion or deflection that occurs during intravascular operation, and improves the accuracy and reliability of navigation. One end of the developing spring 200 is fixedly connected to the core wire 100 head, and the other end is fixedly connected to the flat wire tube 300. This connection method enhances the structural integrity of the entire guide wire. It ensures a tight connection between the core wire 100, the developing spring 200 and the flat wire tube 300, and prevents loosening or falling off during operation. The development spring 200 is consistent with the axial dimension of the core wire 100 head, which means that the development spring 200 can completely cover the key part of the core wire 100 head, thereby providing clearer and more accurate positioning information under the guide wire light or other imaging equipment. The end of the core wire 100 head away from the core wire 100 trunk is spherical in shape, and the spherical head can reduce friction and resistance with the blood vessel wall, reducing the risk of blood vessel damage.

[0036] like Figure 3As shown, an outer coating 400 is provided on the flat wire tube 300, and the flat wire tube 300, the core wire 100 trunk and the outer coating 400 are coaxially arranged. The length of the flat wire tube 300 is consistent with the length of the core wire 100 trunk and the length of the outer coating 400. The flat wire tube 300 includes a plurality of flat wire units, and the cross-sectional external contour of each flat wire unit is consistent and is one of an ellipse, a triangle and a hexagon. The plurality of flat wire units are connected in sequence. The cross-sectional external contour of each flat wire unit is an ellipse with a consistent major axis size and a consistent minor axis size. The coaxial arrangement ensures that the flat wire tube 300, the core wire 100 trunk and the outer coating 400 are aligned in the axial direction, and the twisting or deflection of the guide wire during operation is reduced. This design improves the stability and accuracy of the guide wire during intravascular navigation. The elliptical cross section of the flat wire unit reduces the contact area with the vascular wall, reduces friction and resistance. This helps to reduce the risk of vascular damage, reduces the gap between the guide wire and the catheter, and reduces the occurrence of the jamming phenomenon. This helps reduce the "window sill" effect in curved vessels or branches, and improves the pass rate of the guidewire in complex vascular structures. The flat wire tube 300 design, which is composed of multiple flat wire units connected in sequence, provides good structural strength and flexibility. This design allows the guidewire to have good compliance and flexibility while maintaining sufficient strength to adapt to blood vessels of different shapes.

[0037] The cross-sectional shape of the flat wire is elliptical. This design can significantly improve the flexibility of the guide wire while maintaining a certain supporting force. The flat wire can better adapt to the complex anatomical structure of the blood vessel when bending, reducing the pressure and damage to the blood vessel wall.

[0038] The flat wire tube 300 uses a developing material, and its flat cross-sectional shape can provide a larger developing area, making the development of the guidewire clearer under the guidewire ray. It improves the flexibility, twist control, pushability, sliding property and development effect of the guidewire, while reducing friction and the "window sill effect". These improvements can significantly improve the performance of the guidewire in complex vascular environments, reduce surgical risks, and increase the success rate of surgery.

[0039] A guide wire with a flat wire tube 300, a core wire 100, a developing spring 200 and a flat wire tube 300 respectively arranged on the outside of the core wire 100, and an outer coating 400 arranged on the flat wire tube 300. The cross-sectional shape of the flat wire tube 300 is elliptical, which reduces the contact area between the guide wire and the catheter, can reduce the gap between the guide wire and the catheter, reduce the jamming phenomenon, and reduce the probability of the windowsill effect, thereby solving the defect of the windowsill effect caused by the large diameter difference between the guide wire and the catheter during use in the prior art.

[0040] The core wire 100 material is one of nickel-titanium alloy, stainless steel and nickel-tanium alloy. Nickel-titanium alloy has significant superelasticity and shape memory effect, which means it can return to its original shape after being subjected to external force. In intravascular operations, this property enables the guidewire to better adapt to the bends and branches of blood vessels, reducing the risk of jamming and damage. Nickel-titanium alloy has been shown to have good biocompatibility, which means it is not toxic or irritating to human tissue. Nickel-titanium alloy has excellent fatigue resistance and corrosion resistance, and can maintain stable performance in complex and harsh physiological environments. This helps to extend the service life of the guidewire and reduce failures caused by material fatigue or corrosion.

[0041] Stainless steel is a high-strength and rigid material that can withstand large tension and pressure, and the stainless steel core wire 100 can provide reliable support and stability. Both nickel-titanium alloy and stainless steel core wire 100 can provide reliable structural support and navigation accuracy. This helps to more accurately position and operate, thereby improving the success rate and safety of the operation.

[0042] Nickel-tantalum alloy is an alloy material composed of nickel and tantalum. Its high density can enhance the development performance of the guide wire. When the core wire 100 and the flat wire tube 300 are combined, the combination methods used are nesting, welding and bonding. For the nesting combination, the development guide wire is inserted into the metal flat wire tube; for the welding combination, the development guide wire is inserted into the channel and then adjusted and fixed; for the bonding combination, the bonding surface of the development guide wire and the metal flat wire tube is coated with adhesive and pressed.

[0043] The material of the developing spring 200 is a metal with a developing function, and the metal with a developing function is one of platinum-nickel alloy, platinum-tungsten alloy and platinum-iridium alloy. The preparation process is to form a metal with a developing function by winding, and the structure of the developing spring 200 is one of a single-strand spring and a double-strand spring. Platinum-nickel alloy has good developing performance and can be clearly displayed under the guide wire light or other imaging equipment. This makes it possible to accurately judge the position and state of the guide wire and improve the accuracy and safety of the operation. Platinum-tungsten alloy is a platinum alloy composed of tungsten added to platinum, and has high tensile strength, resistivity and resistance strain sensitivity coefficient, as well as low resistance temperature coefficient and excellent oxidation resistance. Platinum-iridium alloy is a platinum-based binary alloy containing iridium, which has high hardness, high melting point, high corrosion resistance and low contact resistance. The developing effect of the developing spring 200 helps to locate the guide wire in complex or curved vascular structures, which is crucial for intravascular interventional surgery that requires precise navigation to the target position. The single-strand spring structure is relatively simple, provides sufficient flexibility and compliance, and can adapt to vascular structures of different shapes. Compared with single-strand springs, double-strand springs have higher stability and rigidity, and double-strand springs can provide better support and stability.

[0044] The end of the core wire 100 head away from the core wire 100 trunk is spherical in shape. The spherical head can reduce the contact area and friction with the blood vessel wall, making the guide wire more flexible when passing through a curved blood vessel. The spherical head has better compliance and guidance, and can adapt to the bends and branches of the blood vessels more easily. The design of the spherical head reduces the jamming phenomenon between the blood vessel wall, reduces the friction of the guide wire when operating in the blood vessel, and reduces the risk of blood vessel damage and guide wire damage caused by jamming.

[0045] There is a deflection angle between the long axis straight lines of the cross section of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. By setting the same deflection angle and consistent deflection direction, a closer and more orderly connection can be formed between adjacent flat wire units. This orderly arrangement helps to disperse external stress and improve the strength of the entire flat wire tube 300 structure. The existence of the deflection angle enables the flat wire tube 300 to have good flexibility while maintaining a certain structural strength. This flexibility helps the flat wire tube 300 to better adapt to the bends and branches of the blood vessels and reduce the risk of jamming and injury during intravascular operation. The deflection angles and consistent directions of adjacent flat wire units help to form a smoother fluid channel. It can reduce the turbulence and resistance of blood when passing through the flat wire tube 300, reduce the pressure and damage to the blood vessel wall, and thus optimize the hemodynamic performance.

[0046] The deflection angle of adjacent flat wire units is 360° / N, where N is a factor of 360 and is an even number greater than 2. When the deflection angle is 360° / N, the adjacent flat wire units will present a regular arrangement structure. This makes the flat wire tube 300 present an orderly and uniform appearance on a macro scale, which helps to improve the overall stability. The regular arrangement structure helps to disperse external stress, so that the flat wire tube 300 can distribute stress more evenly when subjected to external force, so that it can better adapt to the complex intravascular environment. There is a deflection angle between adjacent flat wire units, and the flat wire tube 300 has good flexibility while maintaining a certain structural strength. This flexibility allows the flat wire tube 300 to more easily adapt to the bends and branches of blood vessels, reducing the risk of jamming and damage during intravascular operations.

[0047] The regular deflection angle makes the inner wall of the flat wire tube 300 smoother, reducing the friction between the flat wire tube 300 and the guide wire. This helps the guide wire pass through the catheter more smoothly, reducing the risk of jamming and damage. The deflection structure of the flat wire unit can provide better guidance for the guide wire. In a complex intravascular environment, the guide wire can more easily move along the deflection direction of the flat wire tube 300 to reach the target position, and can make the catheter and the guide wire have a stable centering relationship.

[0048] When the total deflection angle of several continuous flat wire units along the axial direction reaches 360°, the total length of several continuous flat wire units is consistent. The total length of the continuous flat wire units remains consistent after deflection of 360°, which makes the flat wire tube 300 have a uniform spatial distribution in the axial direction. The stable circumferential structure and uniform spatial distribution make it easier and more accurate for doctors to manipulate catheters and guidewires. The stable circumferential structure and uniform spatial distribution help reduce the turbulence and eddy current of blood on the surface of the flat wire tube 300. This helps to reduce damage to blood cells and enhance the blood compatibility of the flat wire tube 300.

[0049] The ratio of the long and short axes of the flat wire unit is 3-2:1, the ratio of the short axis to the radius of the core wire 100 is 0.75-1.25:1, and the radius size range of the core wire 100 is 0.01-0.2mm. The design of the ratio of the long and short axes enables the flat wire unit to have good flexibility while maintaining a certain structural strength. This flexibility helps the flat wire tube 300 to better adapt to the bends and branches of the blood vessels and reduce the risk of jamming and injury during intravascular operation. The size range of the radius of the core wire 100 ensures that the core wire 100 has sufficient strength to support the entire structure while not being too rigid, thereby maintaining good operational flexibility. The shape and arrangement of the flat wire unit can provide better guidance for the guide wire. In a complex intravascular environment, the guide wire can more easily advance along the shape of the flat wire tube 300 to reach the target position, which helps to improve the accuracy and safety of the operation. The flat wire tube 300 has good flexibility, guidance and spatial adaptability, and doctors can complete the catheter insertion and guide wire guidance process faster, which helps to shorten the operation time.

[0050] The material used for the outer coating 400 is one of modified TPU and PTFE, and the guide wire head is provided with a hydrophilic coating. The cross-sectional outer contour of the outer coating 400 and the cross-sectional outer contour of the flat wire unit are both ellipses with the same ratio of the long and short axes, and the ratio of the long axis of the cross-sectional outer contour of the outer coating 400 to the long axis of the outer contour of the flat wire unit is 1.1-1.3:1. The modified TPU modification process is to obtain a coating material by melt blending thermoplastic polyurethane masterbatch, stearamide and polyvinyl chloride. The mass ratio of thermoplastic polyurethane masterbatch, stearamide and polyvinyl chloride is 90-110:0.5-1:20-50, the temperature during melt blending is 180-220°C, the melt blending time is 10-20min, and extrusion granulation is performed after melt blending, and the screw speed is 180-200 rpm. As a high-performance material, modified TPU has excellent wear resistance, low friction coefficient and aging resistance; PTFE has an extremely low friction coefficient and has excellent chemical stability and biocompatibility. Using modified TPU and PTFE as the material of the outer coating 400 can significantly improve the wear resistance and durability of the outer surface of the flat wire tube 300, and can reduce the friction coefficient between the guide wire and the blood vessel, thereby reducing friction. The coating bonding method is one of dipping, spraying or scraping. The elliptical profile design allows the outer coating 400 to form a close fit with the flat wire unit, enhancing the stability of the entire structure. This design helps to resist external stress and deformation, and prevents the flat wire tube 300 from being damaged or deformed during operation in a blood vessel. The hydrophilic coating set on the guide wire head is made of one of PVP and PEG.

[0051] A transition portion is provided between each adjacent flat wire unit, and the transition portion is used to smooth the adjacent flat wire units. The design of the transition portion makes the connection between adjacent flat wire units smoother, reducing abrupt turns and uneven surfaces. This smooth transition helps reduce friction and damage to the vessel wall during intravascular operations, improving the safety of the operation and the comfort of the patient. The smooth transition portion can provide better guidance for the guide wire, making the guide wire smoother when passing through adjacent flat wire units. This helps to improve the accuracy and efficiency of the operation and reduce the surgical risks caused by the guide wire being stuck or deviating from the target position.

[0052] There is a torsion part between adjacent flat wire units, which can provide rotational force to the catheter, and can rotate the guide wire when the catheter is stuck, so that the catheter opening and the guide wire transition part overlap, and the catheter is reset during the guide wire rotation process to ensure the reset of the catheter.

[0053] Embodiment 1

[0054] This embodiment specifically describes a guide wire with a flat wire tube, including: a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube:

[0055] The core wire comprises: a core wire head, and a core wire body fixedly connected to the core wire head, the core wire head is coaxially arranged with a developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire body is fixedly connected to the flat wire tube, and the other end of the developing spring away from the core wire body is fixedly connected to the core wire head;

[0056] The flat wire tube, the core wire body and the outer coating are coaxially arranged. The length of the flat wire tube is consistent with the length of the core wire body and the length of the outer coating. The flat wire tube includes a plurality of flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with consistent major and minor axis dimensions. The plurality of flat wire units are connected in sequence.

[0057] The core wire material is stainless steel, the developing spring material is a metal with developing function, the metal with developing function is a platinum-nickel alloy, the preparation process is to coil the metal with developing function, and the developing spring structure is a single-strand spring. The end of the core wire head away from the core wire body is spherical.

[0058] There is a deflection angle between the long axis lines of the cross-sections of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. The deflection angle of adjacent flat wire units is 30°, and when the total deflection angle of several continuous flat wire units along the axial direction reaches 360°, the total length of several continuous flat wire units is consistent.

[0059] The ratio of the long and short axes of the flat wire unit is 1.5:1, the ratio of the short axis to the radius of the core wire is 1.25:1, and the radius of the core wire is 0.1mm. The outer coating is made of modified TPU, and the outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of the long and short axes, and the ratio of the long axis of the outer contour of the cross section of the outer coating to the long axis of the outer contour of the flat wire unit is 1.2:1. A transition part is provided between each adjacent flat wire unit, and the transition part is used to smooth the adjacent flat wire units.

[0060] Embodiment 2

[0061] This embodiment specifically describes a guide wire with a flat wire tube, including: a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube:

[0062] The core wire comprises: a core wire head, and a core wire body fixedly connected to the core wire head, the core wire head is coaxially arranged with a developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire body is fixedly connected to the flat wire tube, and the other end of the developing spring away from the core wire body is fixedly connected to the core wire head;

[0063] The flat wire tube, the core wire body and the outer coating are coaxially arranged. The length of the flat wire tube is consistent with the length of the core wire body and the length of the outer coating. The flat wire tube includes a plurality of flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with consistent major and minor axis dimensions. The plurality of flat wire units are connected in sequence.

[0064] The core wire material is stainless steel, the developing spring material is a metal with developing function, the metal with developing function is a platinum-nickel alloy, the preparation process is to coil the metal with developing function, and the developing spring structure is a single-strand spring. The end of the core wire head away from the core wire body is spherical.

[0065] There is a deflection angle between the long axis lines of the cross-sections of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. The deflection angle of adjacent flat wire units is 30°, and when the total deflection angle of several continuous flat wire units along the axial direction reaches 360°, the total length of several continuous flat wire units is consistent.

[0066] The ratio of the long and short axes of the flat wire unit is 2:1, the ratio of the short axis to the core wire radius is 1.25:1, and the core wire radius is 0.1mm. The outer coating is made of modified TPU, and the outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of the long and short axes, and the ratio of the long axis of the outer contour of the cross section of the outer coating to the long axis of the outer contour of the flat wire unit is 1.2:1. A transition part is provided between each adjacent flat wire unit, and the transition part is used to smooth the adjacent flat wire units.

[0067] Embodiment 3

[0068] This embodiment specifically describes a guide wire with a flat wire tube, including: a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube:

[0069] The core wire comprises: a core wire head, and a core wire body fixedly connected to the core wire head, the core wire head is coaxially arranged with a developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire body is fixedly connected to the flat wire tube, and the other end of the developing spring away from the core wire body is fixedly connected to the core wire head;

[0070] The flat wire tube, the core wire body and the outer coating are coaxially arranged. The length of the flat wire tube is consistent with the length of the core wire body and the length of the outer coating. The flat wire tube includes a plurality of flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with consistent major and minor axis dimensions. The plurality of flat wire units are connected in sequence.

[0071] The core wire material is stainless steel, the developing spring material is a metal with developing function, the metal with developing function is a platinum-nickel alloy, the preparation process is to coil the metal with developing function, and the developing spring structure is a single-strand spring. The end of the core wire head away from the core wire body is spherical.

[0072] There is a deflection angle between the long axis lines of the cross-sections of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. The deflection angle of adjacent flat wire units is 30°, and when the total deflection angle of several continuous flat wire units along the axial direction reaches 360°, the total length of several continuous flat wire units is consistent.

[0073] The ratio of the long and short axes of the flat wire unit is 2.5:1, the ratio of the short axis to the core wire radius is 1.25:1, and the core wire radius is 0.1mm. The outer coating is made of modified TPU, and the outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of the long and short axes, and the ratio of the long axis of the outer contour of the cross section of the outer coating to the long axis of the outer contour of the flat wire unit is 1.2:1. A transition part is provided between each adjacent flat wire unit, and the transition part is used to smooth the adjacent flat wire units.

[0074] Embodiment 4

[0075] This embodiment specifically describes a guide wire with a flat wire tube, including: a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube:

[0076] The core wire comprises: a core wire head, and a core wire body fixedly connected to the core wire head, the core wire head is coaxially arranged with a developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire body is fixedly connected to the flat wire tube, and the other end of the developing spring away from the core wire body is fixedly connected to the core wire head;

[0077] The flat wire tube, the core wire body and the outer coating are coaxially arranged. The length of the flat wire tube is consistent with the length of the core wire body and the length of the outer coating. The flat wire tube includes a plurality of flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with consistent major and minor axis dimensions. The plurality of flat wire units are connected in sequence.

[0078] The core wire material is stainless steel, the developing spring material is a metal with developing function, the metal with developing function is a platinum-nickel alloy, the preparation process is to coil the metal with developing function, and the developing spring structure is a single-strand spring. The end of the core wire head away from the core wire body is spherical.

[0079] There is a deflection angle between the long axis lines of the cross-sections of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. The deflection angle of adjacent flat wire units is 30°, and when the total deflection angle of several continuous flat wire units along the axial direction reaches 360°, the total length of several continuous flat wire units is consistent.

[0080] The ratio of the long and short axes of the flat wire unit is 3:1, the ratio of the short axis to the core wire radius is 1.25:1, and the core wire radius is 0.1mm. The outer coating is made of modified TPU, and the outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of the long and short axes, and the ratio of the long axis of the outer contour of the cross section of the outer coating to the long axis of the outer contour of the flat wire unit is 1.2:1. A transition part is provided between each adjacent flat wire unit, and the transition part is used to smooth the adjacent flat wire units.

[0081] Embodiment 5

[0082] This embodiment specifically describes a guide wire with a flat wire tube, including: a core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube:

[0083] The core wire comprises: a core wire head, and a core wire body fixedly connected to the core wire head, the core wire head is coaxially arranged with a developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire body is fixedly connected to the flat wire tube, and the other end of the developing spring away from the core wire body is fixedly connected to the core wire head;

[0084] The flat wire tube, the core wire body and the outer coating are coaxially arranged. The length of the flat wire tube is consistent with the length of the core wire body and the length of the outer coating. The flat wire tube includes a plurality of flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with consistent major and minor axis dimensions. The plurality of flat wire units are connected in sequence.

[0085] The core wire material is stainless steel, the developing spring material is a metal with developing function, the metal with developing function is a platinum-nickel alloy, the preparation process is to coil the metal with developing function, and the developing spring structure is a single-strand spring. The end of the core wire head away from the core wire body is spherical.

[0086] There is a deflection angle between the long axis lines of the cross-sections of adjacent flat wire units along the axial direction, the deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent. The deflection angle of adjacent flat wire units is 30°, and when the total deflection angle of several continuous flat wire units along the axial direction reaches 360°, the total length of several continuous flat wire units is consistent.

[0087] The ratio of the long and short axes of the flat wire unit is 3.5:1, the ratio of the short axis to the core wire radius is 1.25:1, and the core wire radius is 0.1mm. The outer coating is made of modified TPU, and the outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of the long and short axes, and the ratio of the long axis of the outer contour of the cross section of the outer coating to the long axis of the outer contour of the flat wire unit is 1.2:1. A transition part is provided between each adjacent flat wire unit, and the transition part is used to smooth the adjacent flat wire units.

[0088] Comparative Example 1

[0089] This comparative example specifically describes a guide wire, including: a core wire, a developing spring and a hypotube respectively arranged on the outside of the core wire, and an outer coating arranged on the hypotube:

[0090] The core wire comprises: a core wire head, and a core wire body fixedly connected to the core wire head, the core wire head is coaxially arranged with a developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire body is fixedly connected to the flat wire tube, and the other end of the developing spring away from the core wire body is fixedly connected to the core wire head;

[0091] The hypotube, the core wire body and the outer coating are coaxially arranged, and the length of the hypotube is consistent with the length of the core wire body and the length of the outer coating. The outer contour of the hypotube cross section is circular, the ratio of the outer diameter to the core wire radius is 1.25:1, and the core wire radius is 0.1mm.

[0092] The core wire material is stainless steel, the developing spring material is a metal with developing function, the metal with developing function is platinum-nickel alloy, the preparation process is to coil the metal with developing function, and the developing spring structure is a single-strand spring. The end of the core wire head away from the core wire body is spherical, and the outer coating material is modified TPU.

[0093] The guide wire was tested for softness using a guide wire softness tester, and the guide wire friction tester was used to test the guide wire friction. The guide wire softness tester is specifically the guide wire head softness tester YY / T1544. The specific method is to clamp the guide wire head 10mm away, maintain the vertical direction, and the speed is 3-8mm / min. The upper clamp carrying the guide wire is pressed down, and the force value of the bottom is increased until the guide wire touches the conical side wall of the clamp, and the head begins to bend. The smaller the force value, the softer the guide wire; the catheter guide wire friction tester is specifically the C610B catheter guide wire friction tester. Force is applied to the guide wire to make the guide wire slide on the surface of the standard test block at a set speed, and the required force is recorded. The test results are shown in Table 1 below.

[0094] Table 1 Test data of guide wire softness and friction in Examples 1 to 5

[0095]

[0096]

[0097] It can be seen from Table 1 that the bending force and friction force required for Examples 1 to 5 are all smaller than those of Comparative Example 1, and the preparation method in the present application is superior.

[0098] In embodiments one to five, as the ratio of the major and minor axes of the flat wire unit gradually increases, the bending force and friction force first decrease and then increase. This is because as the ratio of the major and minor axes of the flat wire unit increases, the ellipse can provide a larger deformation space in the major axis direction when subjected to external force, and can more effectively disperse stress when bending, thereby reducing the force required for bending, so that the initial bending force is reduced. However, during the increase process, the material will experience local stress concentration or excessive deformation when bending, so that the force required for bending begins to increase; due to the optimization of the elliptical structure, the pressure per unit area is reduced, and the generation of friction force is reduced, but when the major and minor axis ratio is too large, the contact area between the guide wire and the test block is uneven and concentrated, resulting in increased friction. The preferred embodiment is embodiment three.

[0099] The above is based on the ideal embodiment of the present invention. Through the above description, relevant personnel can make various changes and modifications without departing from the technical concept of the present invention. The technical scope of the present invention is not limited to the content in the specification, and the technical scope must be determined according to the scope of the claims.

Claims

1. A guide wire with a flat wire tube, comprising: A core wire, a developing spring and a flat wire tube respectively arranged on the outside of the core wire, and an outer coating arranged on the flat wire tube, characterized in that: The core wire comprises: a core wire head and a core wire trunk fixedly connected to the core wire head, the core wire head is coaxially arranged with the developing spring, the developing spring and the core wire head have the same axial dimensions, one end of the developing spring close to the core wire trunk is fixedly connected to the flat wire tube, and one end away from the core wire trunk is fixedly connected to the core wire head; The flat wire tube, the core wire trunk and the outer coating are coaxially arranged, the length of the flat wire tube is consistent with the length of the core wire trunk and the length of the outer coating, the flat wire tube includes a plurality of the flat wire units, the cross-sectional external contour of each of the flat wire units is consistent and is one of an ellipse, a triangle and a hexagon, and the plurality of the flat wire units are connected in sequence; The outer coating is made of one of modified TPU and PTFE, and the guide wire head is provided with a hydrophilic coating.

2. A guide wire with a flat wire tube according to claim 1, characterized in that: The core wire material is one of nickel-titanium alloy, stainless steel and nickel-tanium alloy.

3. A guide wire with a flat wire tube according to claim 1, characterized in that: The developing spring material is a metal with a developing function, and the metal with a developing function is one of a platinum-nickel alloy, a platinum-tungsten alloy, and a platinum-iridium alloy. The preparation process is to form a coil by winding the metal with a developing function, and the developing spring structure is one of a single-strand spring and a double-strand spring.

4. A guide wire with a flat wire tube according to claim 1, characterized in that: The end of the core wire head away from the core wire body is spherical in shape.

5. A guide wire with a flat wire tube according to claim 1, characterized in that: The cross-sectional profile of the flat wire unit is elliptical, and there is a deflection angle between the long axis lines of the cross-sectional views of adjacent flat wire units along the axial direction. The deflection angles of adjacent flat wire units are the same, and the deflection directions of adjacent flat wire units are consistent.

6. A guide wire with a flat wire tube according to claim 5, characterized in that: The deflection angle of adjacent flat wire units is 360° / N, where N is a factor of 360 and is an even number greater than 2.

7. A guide wire with a flat wire tube according to claim 6, characterized in that: When the total deflection angle of a plurality of continuous flat wire units along the axial direction reaches 360°, the total lengths of the plurality of continuous flat wire units are consistent.

8. A guide wire with a flat wire tube according to claim 5, characterized in that: The ratio of the major axis to the minor axis of the flat wire unit is 3-2:1, the ratio of the minor axis to the radius of the core wire is 0.75-1.25:1, and the radius size range of the core wire is 0.01-0.2 mm.

9. A guide wire with a flat wire tube according to claim 8, characterized in that: The outer contour of the cross section of the outer coating and the outer contour of the cross section of the flat wire unit are both ellipses with the same ratio of major axis to minor axis, and the ratio of the major axis of the cross section of the outer coating to the major axis of the outer contour of the flat wire unit is 1.1-1.3:

1.

10. A guide wire with a flat wire tube according to claim 5, characterized in that: A transition portion is provided between each of the adjacent flat wire units, and the transition portion is used for smoothing the adjacent flat wire units.

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