A guide wire with a flat wire tube

Abstract

The present invention discloses 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, wherein the cross-sectional shape of the flat wire tube is one of an ellipse, a triangle and a hexagon, which reduces the contact area between the guide wire and the catheter, can open the gap between the guide wire and the catheter, reduce the jamming phenomenon, reduce the probability of the windowsill effect, and solve the problem of the windowsill effect caused by the large diameter difference between the guide wire and the catheter during use in the prior art; 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 in the axial direction, which can enable the catheter to advance along the deflection direction of the flat wire tube, thereby reducing the contact area between the guide wire and the catheter and 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, and reduce the jamming phenomenon during use.

Description

Technical Field

[0001] The present 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, particularly when using catheters and guidewires. It refers to the large diameter difference between the catheter and guidewire, which creates a large gap between them. This gap creates a "window sill"-like obstruction during intravascular navigation around tortuous anatomical structures or branching vessels, making it difficult for the catheter to pass smoothly through these complex vascular locations.

[0003] When a guidewire and catheter are passed through a curved section or branch of a blood vessel, the "window sill effect" causes the catheter to become stuck in these complex structures and prevent smooth advancement. This is because the outer diameter of the catheter is relatively large, while the guidewire is not flexible enough to propel the catheter through narrow or curved blood vessel segments. The window sill effect can prolong the operation, increase the difficulty of the procedure, 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 surgical risks but also causes additional trauma to the patient.

[0004] Therefore, it is necessary to improve the guide wire 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 guidewire with a flat wire tube, aiming to solve the defect of the prior art that the guidewire has a window sill effect caused by the large diameter difference between the guidewire and the catheter during use. To achieve the above object, the present invention adopts the following technical solution: a guidewire with a flat wire tube, comprising: a core wire, a developing spring and a flat wire tube respectively disposed on the exterior of the core wire, and an outer coating disposed on the flat wire tube:

[0006] The core wire includes: a core wire head and a core wire body 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, the developing spring has one end close to the core wire body fixedly connected to the flat wire tube, and the end away from the core wire body 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 flat wire units, the cross-sectional external contour of each flat wire unit is consistent and is one of an elliptical, triangular and hexagonal shape, and the plurality of 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-tantalite.

[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, and 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 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 the same.

[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. The cross-sectional shape of the flat wire tube is one of an ellipse, a triangle and a hexagon, which reduces 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 window sill effect, thereby solving 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.

[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, while the high strength and rigidity of stainless steel can withstand greater tension and pressure. Compared with existing technologies, it can provide reliable structural support and navigation accuracy. This facilitates more accurate positioning and operation.

[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 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 section of adjacent flat wire units along the axial direction, which can enable the catheter to advance along the deflection direction of the flat wire tube. Compared with the existing technology, the contact area between the guide wire and the catheter is reduced, and the guide wire is prevented 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 and the guide wire transition portion coincide with each other, 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments described in the present invention. Those skilled in the art can also derive other drawings based on these drawings without inventive efforts.

[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 according to 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 clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts 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. However, the present invention may also be implemented in other ways different from those described herein. Therefore, the scope of protection 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" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying 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 the indicated technical features. Therefore, features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0033] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "installed," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on 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 comprises a core wire head 100 and a core wire body 100 fixedly connected to the core wire head 100. The core wire head 100 is coaxially arranged with a developing spring 200, and the developing spring 200 and the core wire head 100 have the same axial dimensions. The developing spring 200's end closest to the core wire body 100 is fixedly connected to the flat wire tube 300, while the end farther from the core wire body 100 is fixedly connected to the core wire head 100. The coaxial arrangement of the core wire head 100 and the developing spring 200 ensures axial stability of the entire guidewire. This coaxial design reduces twisting or deflection during intravascular manipulation, improving navigation accuracy and reliability. The developing spring 200, with one end fixedly connected to the core wire head 100 and the other end fixedly connected to the flat wire tube 300, enhances the structural integrity of the entire guidewire. This ensures a tight connection between the core wire 100, developing spring 200, and flat wire tube 300, preventing loosening or dislodging during operation. The developing spring 200 is axially aligned with the core wire 100 head, completely covering the critical portion of the core wire 100 head, providing clearer and more accurate positioning information under a guidewire light or other imaging device. The end of the core wire 100 head, distal to the core wire 100 trunk, is spherical, reducing friction and resistance with the vessel wall, thereby lowering the risk of vascular damage.

[0036] like Figure 3As shown, the flat wire tube 300 is provided with an outer coating 400. 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 comprises a plurality of flat wire units, each of which has a uniform cross-sectional external profile, one of elliptical, triangular, and hexagonal. The flat wire units are sequentially connected. The cross-sectional external profile of each flat wire unit is an ellipse with consistent major and minor axis dimensions. The coaxial arrangement ensures axial alignment of the flat wire tube 300, the core wire 100 trunk, and the outer coating 400, reducing twisting or deflection of the guidewire during operation. This design improves the stability and accuracy of the guidewire during intravascular navigation. The elliptical cross-section of the flat wire unit reduces the contact area with the vessel wall, reducing friction and resistance. This helps reduce the risk of vascular damage, minimizes the gap between the guidewire and the catheter, and reduces the occurrence of jamming. This helps reduce the "window sill" effect in curved vessels or branches, improving the guidewire's passage rate through complex vascular structures. The flat wire tube 300, composed of multiple flat wire units connected in sequence, provides excellent structural strength and flexibility. This design allows the guidewire to maintain sufficient strength while maintaining good compliance and flexibility to adapt to various vessel 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 vessels when bending, reducing pressure and damage to the blood vessel wall.

[0038] The flat wire tube 300 utilizes a developer-friendly material. Its flat cross-section provides a larger development area, making the guidewire appear clearer under guidewire radiation. This improves the guidewire's flexibility, twist control, pushability, sliding properties, and development quality, while also reducing friction and the "window sill effect." These improvements significantly enhance guidewire performance in complex vascular environments, reducing surgical risks and increasing surgical success rates.

[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 narrow the gap between the guide wire and the catheter, reduce the jamming phenomenon, and reduce the probability of the window sill effect, thereby solving 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.

[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 that 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 that 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 highly strong and rigid material capable of withstanding significant tension and compression. The stainless steel core wire 100 provides reliable support and stability. Both nickel-titanium alloy and stainless steel core wire 100 offer reliable structural support and navigational precision. This facilitates more accurate positioning and manipulation, thereby improving surgical success and safety.

[0042] Nickel-tantalum alloy is an alloy composed of nickel and tantalum. Its high density enhances the development performance of the guidewire. The core wire 100 and the flat wire tube 300 can be joined using nesting, welding, or gluing. For nesting, the development guidewire is inserted into the metal flat wire tube. For welding, the development guidewire is inserted into the hole, adjusted, and secured. For gluing, adhesive is applied to the joint surface of the development guidewire and the metal flat wire tube and pressed together.

[0043] The developing spring 200 is made of a metal with a developing function, which can be one of platinum-nickel alloy, platinum-tungsten alloy, and platinum-iridium alloy. The manufacturing process involves winding the metal with a developing function into a coil. The developing spring 200 can be constructed as either a single-strand spring or a double-strand spring. Platinum-nickel alloy has excellent developing properties, enabling clear visualization under guidewire light or other imaging equipment. This enables accurate determination of the guidewire's position and status, improving surgical precision and safety. Platinum-tungsten alloy, a platinum-based alloy with tungsten added, exhibits high tensile strength, resistivity, and resistance strain sensitivity, as well as a low temperature coefficient of resistance and excellent oxidation resistance. Platinum-iridium alloy, a platinum-based binary alloy containing iridium, exhibits high hardness, a high melting point, high corrosion resistance, and low contact resistance. The developing effect of the developing spring 200 facilitates guidewire positioning within complex or tortuous vascular structures, which is crucial for intravascular interventional procedures that require precise navigation to the target location. The single-strand spring structure is relatively simple, providing sufficient flexibility and conformability to accommodate diverse vascular 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 curved blood vessels. The spherical head has better compliance and guidance, and can adapt to the bends and branches of blood vessels more easily. The design of the spherical head reduces the jamming phenomenon between the head and the blood vessel wall, thereby reducing the friction of the guide wire during operation in the blood vessel and reducing the risk of blood vessel damage and guide wire damage caused by jamming.

[0045] Adjacent flat wire units have a deflection angle along the longitudinal axis of their cross-sections in the axial direction. The deflection angles of adjacent flat wire units are identical and their deflection directions are consistent. By setting the same deflection angles and consistent deflection directions, a tighter and more orderly connection is achieved between adjacent flat wire units. This orderly arrangement helps disperse external stress and enhance the overall structural strength of the flat wire tube 300. The presence of the deflection angles ensures that the flat wire tube 300 maintains a certain level of structural strength while also possessing excellent flexibility. This flexibility helps the flat wire tube 300 better adapt to the bends and branches of blood vessels, reducing the risk of jamming and injury during intravascular manipulation. The deflection angles and consistent direction of adjacent flat wire units contribute to a smoother fluid pathway, reducing turbulence and resistance as blood passes through the flat wire tube 300, reducing stress and damage to the vessel wall, and thereby optimizing hemodynamic performance.

[0046] The deflection angle of adjacent flat wire units is 360° / N, where N is a factor of 360 and 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 friction with the guidewire. This helps the guidewire pass through the catheter more smoothly, reducing the risk of jamming and damage. The deflection structure of the flat wire unit provides better guidance for the guidewire. In the complex intravascular environment, the guidewire can more easily advance along the deflection direction of the flat wire tube 300 to reach the target location, and can maintain a stable centering relationship between the catheter and the guidewire.

[0048] When the total deflection angle of the continuous flat wire units along the axis reaches 360°, the total length of the continuous flat wire units is consistent. This consistent total length after 360° deflection ensures that the flat wire tube 300 has 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 the catheter and guidewire. This helps reduce turbulence and eddy currents on the surface of the flat wire tube 300, thereby minimizing damage to blood cells and enhancing the hemocompatibility of the flat wire tube 300.

[0049] The ratio of the major axis to minor axis of the flat wire unit is 3-2:1, and the ratio of the minor axis to the radius of the core wire 100 is 0.75-1.25:1. The radius of the core wire 100 ranges from 0.01 to 0.2 mm. This design ensures that the flat wire unit maintains structural strength while also possessing excellent flexibility. This flexibility helps the flat wire tube 300 better adapt to the bends and branches of blood vessels, reducing the risk of jamming and injury during intravascular procedures. The range of core wire 100 radius sizes ensures sufficient strength to support the entire structure while remaining moderately rigid, thus maintaining excellent operational flexibility. The shape and arrangement of the flat wire units provide improved guidance for the guidewire. In complex intravascular environments, the guidewire can more easily follow the shape of the flat wire tube 300 to reach the target location, improving surgical precision and safety. The excellent flexibility, guidance, and spatial adaptability of the flat wire tube 300 allow physicians to more quickly complete catheter insertion and guidewire guidance, thus shortening surgical procedures.

[0050] The outer coating 400 is made of either modified TPU or PTFE, and the guide wire head is provided with a hydrophilic coating. The cross-sectional profile of the outer coating 400 and the cross-sectional profile of the flat filament unit are both elliptical, with the same major-to-minor axis ratio. The ratio of the major axis of the outer coating 400 cross-sectional profile to the major axis of the flat filament unit is 1.1-1.3:1. The modified TPU is prepared by melt-blending a thermoplastic polyurethane masterbatch, stearamide, and polyvinyl chloride (PVC). The mass ratio of the thermoplastic polyurethane masterbatch, stearamide, and polyvinyl chloride is 90-110:0.5-1:20-50. The melt-blending temperature is 180-220°C, and the melt-blending time is 10-20 minutes. After melt-blending, extrusion pelletization is performed at a screw speed of 180-200 rpm. Modified TPU, as a high-performance material, has excellent wear resistance, low friction coefficient and aging resistance; PTFE has an extremely low friction coefficient and 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 is combined by one of dipping, spraying or scraping. The elliptical profile design allows a close fit between the outer coating 400 and the flat wire unit, enhancing the stability of the entire structure. This design helps to resist external stress and deformation, and prevent the flat wire tube 300 from being damaged or deformed during operation in a blood vessel. The hydrophilic coating provided on the guide wire head is made of one of PVP and PEG.

[0051] A transition section is provided between each adjacent flat wire unit to smooth the connection between them. This design allows for a smoother connection between adjacent flat wire units, reducing abrupt turns and uneven surfaces. This smooth transition helps reduce friction and damage to the vessel wall during intravascular procedures, improving surgical safety and patient comfort. The smooth transition section also provides better guidance for the guidewire, allowing it to pass more smoothly through adjacent flat wire units. This helps improve surgical precision and efficiency, reducing surgical risks caused by guidewire jamming or deviation from its target position.

[0052] There is a torsional part between adjacent flat wire units, which can provide rotational force to the catheter. When the catheter is stuck, the guide wire can be rotated so that the catheter opening and the guide wire transition part coincide with each other, and the catheter can be reset during the guide wire rotation process to ensure the reset of the catheter.

[0053] Example 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 includes: a core wire head and a core wire body fixedly connected to the core wire head. The core wire head and the developing spring are coaxially arranged. The developing spring and the core wire head have the same axial dimensions. The developing spring has an end close to the core wire body fixedly connected to the flat wire tube, and an end away from the core wire body 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 several flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with the same major axis and minor axis dimensions. Several flat wire units are connected in sequence.

[0057] The core wire is made of stainless steel, and the developing spring is made of a metal with a developing function, a platinum-nickel alloy. The metal is coiled to form a single-strand spring. The end of the core wire, away from the core wire body, is spherical.

[0058] There is a deflection angle between the major 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°. When the total deflection angle of several consecutive flat wire units along the axial direction reaches 360°, the total length of the several consecutive flat wire units is the same.

[0059] The ratio of the major axis to minor axis of the flat filament unit is 1.5:1, and the ratio of the minor axis to the core radius is 1.25:1. The core radius is 0.1mm. The outer coating is made of modified TPU. The cross-sectional profile of the outer coating and the cross-sectional profile of the flat filament unit are both elliptical with the same major-minor axis ratio. The ratio of the major axis of the outer cross-sectional profile of the outer coating to the major axis of the flat filament unit is 1.2:1. A transition section is provided between each adjacent flat filament unit to smooth the adjacent units.

[0060] Example 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 includes: a core wire head and a core wire body fixedly connected to the core wire head. The core wire head and the developing spring are coaxially arranged. The developing spring and the core wire head have the same axial dimensions. The developing spring has an end close to the core wire body fixedly connected to the flat wire tube, and an end away from the core wire body 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 several flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with the same major axis and minor axis dimensions. Several flat wire units are connected in sequence.

[0064] The core wire is made of stainless steel, and the developing spring is made of a metal with a developing function, a platinum-nickel alloy. The metal is coiled to form a single-strand spring. The end of the core wire, away from the core wire body, is spherical.

[0065] There is a deflection angle between the major 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°. When the total deflection angle of several consecutive flat wire units along the axial direction reaches 360°, the total length of the several consecutive flat wire units is the same.

[0066] The ratio of the major axis to minor axis of the flat filament unit is 2:1, and the ratio of the minor axis to the core radius is 1.25:1. The core radius is 0.1mm. The outer coating is made of modified TPU. The cross-sectional profile of the outer coating and the cross-sectional profile of the flat filament unit are both elliptical with the same major-minor axis ratio. The ratio of the major axis of the outer cross-sectional profile of the outer coating to the major axis of the flat filament unit is 1.2:1. A transition section is provided between each adjacent flat filament unit to smooth the transition between adjacent units.

[0067] Example 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 includes: a core wire head and a core wire body fixedly connected to the core wire head. The core wire head and the developing spring are coaxially arranged. The developing spring and the core wire head have the same axial dimensions. The developing spring has an end close to the core wire body fixedly connected to the flat wire tube, and an end away from the core wire body 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 several flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with the same major axis and minor axis dimensions. Several flat wire units are connected in sequence.

[0071] The core wire is made of stainless steel, and the developing spring is made of a metal with a developing function, a platinum-nickel alloy. The metal is coiled to form a single-strand spring. The end of the core wire, away from the core wire body, is spherical.

[0072] There is a deflection angle between the major 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°. When the total deflection angle of several consecutive flat wire units along the axial direction reaches 360°, the total length of the several consecutive flat wire units is the same.

[0073] The ratio of the major axis to minor axis of the flat filament unit is 2.5:1, and the ratio of the minor axis to the core radius is 1.25:1. The core radius is 0.1mm. The outer coating is made of modified TPU. The cross-sectional profile of the outer coating and the cross-sectional profile of the flat filament unit are both elliptical with the same major-minor axis ratio. The ratio of the major axis of the outer cross-sectional profile of the outer coating to the major axis of the flat filament unit is 1.2:1. A transition section is provided between each adjacent flat filament unit to smooth the transition between adjacent units.

[0074] Example 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 includes: a core wire head and a core wire body fixedly connected to the core wire head. The core wire head and the developing spring are coaxially arranged. The developing spring and the core wire head have the same axial dimensions. The developing spring has an end close to the core wire body fixedly connected to the flat wire tube, and an end away from the core wire body 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 several flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with the same major axis and minor axis dimensions. Several flat wire units are connected in sequence.

[0078] The core wire is made of stainless steel, and the developing spring is made of a metal with a developing function, a platinum-nickel alloy. The metal is coiled to form a single-strand spring. The end of the core wire, away from the core wire body, is spherical.

[0079] There is a deflection angle between the major 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°. When the total deflection angle of several consecutive flat wire units along the axial direction reaches 360°, the total length of the several consecutive flat wire units is the same.

[0080] The ratio of the major axis to minor axis of the flat filament unit is 3:1, the ratio of the minor axis to the core radius is 1.25:1, and the core radius is 0.1mm. The outer coating is made of modified TPU. The cross-sectional profile of the outer coating and the cross-sectional profile of the flat filament unit are both elliptical with the same major-minor axis ratio. The ratio of the major axis of the outer cross-sectional profile of the outer coating to the major axis of the flat filament unit is 1.2:1. A transition section is provided between each adjacent flat filament unit to smooth the adjacent units.

[0081] Example 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 includes: a core wire head and a core wire body fixedly connected to the core wire head. The core wire head and the developing spring are coaxially arranged. The developing spring and the core wire head have the same axial dimensions. The developing spring has an end close to the core wire body fixedly connected to the flat wire tube, and an end away from the core wire body 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 several flat wire units. The outer contour of the cross section of each flat wire unit is an ellipse with the same major axis and minor axis dimensions. Several flat wire units are connected in sequence.

[0085] The core wire is made of stainless steel, and the developing spring is made of a metal with a developing function, a platinum-nickel alloy. The metal is coiled to form a single-strand spring. The end of the core wire, away from the core wire body, is spherical.

[0086] There is a deflection angle between the major 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°. When the total deflection angle of several consecutive flat wire units along the axial direction reaches 360°, the total length of the several consecutive flat wire units is the same.

[0087] The ratio of the major axis to minor axis of the flat filament unit is 3.5:1, and the ratio of the minor axis to the core radius is 1.25:1. The core radius is 0.1mm. The outer coating is made of modified TPU. The cross-sectional profile of the outer coating and the cross-sectional profile of the flat filament unit are both elliptical with the same major-minor axis ratio. The ratio of the major axis of the outer cross-sectional profile of the outer coating to the major axis of the flat filament unit is 1.2:1. A transition section is provided between each adjacent flat filament unit to smooth the transition between adjacent units.

[0088] Comparative Example 1

[0089] This comparative example specifically describes a guide wire, comprising: 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 includes: a core wire head and a core wire body fixedly connected to the core wire head. The core wire head and the developing spring are coaxially arranged. The developing spring and the core wire head have the same axial dimensions. The developing spring has an end close to the core wire body fixedly connected to the flat wire tube, and an end away from the core wire body fixedly connected to the core wire head.

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

[0092] The core wire is made of stainless steel, and the developing spring is made of a metal with developing properties, a platinum-nickel alloy. The metal is coiled to form a single-strand spring. The end of the core wire, away from the main body, is spherical, and the outer coating is made of modified TPU.

[0093] The guidewires were tested for softness using a guidewire softness tester, and for friction using a catheter guidewire friction tester (specifically, the YY / T1544 Guidewire Tip Softness Tester). The tester clamps the guidewire 10 mm from the tip, maintaining a vertical orientation at a speed of 3-8 mm / min. The upper clamp holding the guidewire is pressed downward, increasing the force until the guidewire contacts the conical sidewall of the clamp, causing the tip to bend. Lower force indicates a softer guidewire. The catheter guidewire friction tester, specifically the C610B Catheter Guidewire Friction Tester, applies force to the guidewire, forcing it to slide across a standard test block at a set speed. The force required is recorded. The test results are shown in Table 1 below.

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

[0095]

[0096]

[0097] As can be seen from Table 1, 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 this application is superior.

[0098] In Examples 1 to 5, 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 elliptical shape can provide a larger deformation space in the direction of its major axis when subjected to external force, which can more effectively disperse stress during bending, thereby reducing the force required for bending and reducing the initial bending force. However, during the increase, the material will experience local stress concentration or excessive deformation when bending, which will cause the force required for bending to begin to increase; due to the optimization of the elliptical structure, the pressure per unit area is reduced, reducing the generation of friction force, 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 force. The preferred embodiment is Example 3.

[0099] The above description is based on the ideal embodiment of the present invention. Based on the above description, relevant personnel can make various changes and modifications without departing from the technical scope of this invention. The technical scope of this invention is not limited to the content of the specification and 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 includes: a core wire head and a core wire body 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, the developing spring has one end close to the core wire body fixedly connected to the flat wire tube, and the end away from the core wire body 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 flat wire units, the cross-sectional external contour of each flat wire unit is consistent and is one of an elliptical, triangular and hexagonal shape, and the plurality of 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. The 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. The developing spring structure is one of a single-strand spring and a double-strand spring.

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

5. The 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. 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. The 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 an even number greater than 2.

7. The guide wire with a flat wire tube according to claim 6, characterized in that: 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.

8. The 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 core wire radius is 0.75-1.25:1, and the core wire radius size range is 0.01-0.2 mm.

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

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