CN219595574U - Contrast guide wire - Google Patents

Abstract

The embodiment of the utility model provides a contrast guide wire, which comprises a core wire, wherein the core wire is positioned in an inner layer of the guide wire and extends from a proximal end of the guide wire to a head end of the guide wire, the core wire comprises a first section with a certain pre-bending shape and a second section with a linear shape, a spring ring sheath is arranged on the outer side of the first section, a safety net is arranged between the core wire and the spring ring sheath, and a polymer sheath is arranged on the outer side of the second section. The embodiment of the utility model ensures that the head end of the guide wire is soft, has higher breaking force, and simultaneously has excellent torsion control property and deformation resistance, thereby comprehensively improving the comprehensive performance of the guide wire.

Description

Contrast guide wire

Technical Field

The utility model relates to the field of medical devices, in particular to a contrast guide wire.

Background

Guidewires have been widely used in medical interventions such as Percutaneous Transluminal Coronary Angioplasty (PTCA) or percutaneous transluminal vascular angioplasty (PTA). The guide wire provides a basic track for interventional instruments such as a catheter, a bracket, a balloon and the like in interventional diagnosis and treatment processes, and is an indispensable matching product in interventional operation. For example, in coronary stent implantation, a guidewire is first advanced from the radial or femoral artery, and then the proximal end of the guidewire is controlled to rotate the end of the guidewire, thereby advancing the guidewire in a predetermined direction in each branch of the coronary artery. After the guide wire reaches the target position, the balloon catheter of the pre-loaded stent is delivered to the vascular lesion position along the guide wire, and then the subsequent treatment procedure is carried out.

Clinically, the most important and basic performance of the guide wire is the safety of the end of the guide wire, namely, the guide wire is required to have a soft end, so that the phenomenon of perforation in the use process due to the fact that the end of the guide wire is hard is avoided, and meanwhile, the guide wire is required to have higher breaking force (peak pulling force) so as to avoid the phenomenon of breakage or wire falling of the end of the guide wire in the use process. Therefore, in order to ensure softness of the yarn guiding end, the diameter of the head end core wire is generally reduced, and the yarn guiding end breakage phenomenon is easy to occur in clinical use due to small breaking force of the yarn guiding end caused by small diameter of the head end core wire. If the diameter of the core wire of the head end is increased in order to ensure the breaking force of the wire guiding end, the wire guiding end is hard due to the increase of the diameter of the core wire, and the perforation phenomenon easily occurs in the clinical use process.

The guide wire in the prior art has the danger that the head end is easy to break and fall off because the tip end of the core wire does not reach the end of the guide wire (Shaping rib design). And the guide wire has the phenomenon of 'tail flick' because the core wire does not reach the head end, and when the proximal end of the guide wire is rotated, the torsion force cannot be transmitted to the head end of the guide wire, so that the torsion control of the guide wire is insufficient.

Disclosure of Invention

An object of an embodiment of the present utility model is to provide a contrast guidewire to solve the problems in the prior art. In order to solve the technical problems, the embodiment of the utility model adopts the following technical scheme:

the embodiment of the utility model provides a contrast guide wire, which comprises a core wire, wherein the core wire is positioned in an inner layer of the guide wire and extends from a proximal end of the guide wire to a head end of the guide wire, the core wire comprises a first section with a certain pre-bending shape and a second section with a linear shape, a spring ring sheath is arranged on the outer side of the first section, a safety net is arranged between the core wire and the spring ring sheath, and a polymer sheath is arranged on the outer side of the second section.

In some embodiments, the safety mesh is disposed proximate to the distal end of the core wire and is commonly connected to the coil sheath and the head end of the core wire.

In some embodiments, a hydrophilic coating is disposed on the outer surface of the polymeric sheath.

In some embodiments, the hydrophilic coating is made with at least one of a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acrylate coating, or a polymethylvinyl ether-maleic anhydride coating.

In some embodiments, the tip of the core wire is any one of cone, parabolic, and streamline.

In some embodiments, the diameter of the core wire decreases gradually from the proximal end to the head end.

In some embodiments, the core wire is made from at least one of a nickel-titanium alloy, 304 stainless steel, 316 stainless steel, cobalt-based alloy, fe-Mn alloy, cu-Zn alloy, fe-Ni alloy, or Ti-Ni-X alloy.

In some embodiments, the safety mesh is made by braiding wires, either round wires or flat wires, into different mesh densities or different sizes.

In some embodiments, the spring ring sheath is made with a developer spring and/or a stainless steel spring.

In some embodiments, the developing spring is made of at least one of platinum tungsten alloy, platinum nickel alloy, platinum iridium alloy and gold.

The embodiment of the utility model solves the problem of safety of the end of the guide wire head, ensures that the end of the guide wire is soft, has higher breaking force, and simultaneously has excellent torsion control performance and deformation resistance, and particularly, has the requirements of the softness of the end, higher breaking force and excellent torsion control performance, and the hydrophilic coating on the surface ensures that the guide wire has good lubricity and tracking performance, and can comprehensively improve the comprehensive performance of the guide wire.

Drawings

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the present utility model, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a contrast guidewire according to an embodiment of the present utility model;

FIG. 2 is a schematic cross-sectional view of the Z-Z position of a contrast guidewire according to an embodiment of the utility model;

FIG. 3 is an enlarged partial schematic view of a contrast guidewire according to an embodiment of the present utility model;

FIG. 4 is a schematic view of a safety mesh in a contrast guidewire according to an embodiment of the utility model;

FIG. 5 is a schematic view of a safety mesh in a contrast guidewire according to one embodiment of the utility model;

FIG. 6 is a schematic illustration of a tip softness test of a contrast guidewire according to an embodiment of the present utility model;

FIG. 7 is a graph showing the results of a tip softness and breaking force test of a contrast guidewire according to an embodiment of the present utility model.

Reference numerals:

1-core wire; 2-a polymer sheath; 3-a safety net; 4-a spring coil sheath; 5-hydrophilic coating.

Detailed Description

Various aspects and features of the present utility model are described herein with reference to the accompanying drawings.

It should be understood that various modifications may be made to the embodiments of the application herein. Therefore, the above description should not be taken as limiting, but merely as exemplification of the embodiments. Other modifications within the scope and spirit of the utility model will occur to persons of ordinary skill in the art.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the utility model and, together with a general description of the utility model given above, and the detailed description of the embodiments given below, serve to explain the principles of the utility model.

These and other characteristics of the utility model will become apparent from the following description of a preferred form of embodiment, given as a non-limiting example, with reference to the accompanying drawings.

It is also to be understood that, although the utility model has been described with reference to some specific examples, a person skilled in the art will certainly be able to achieve many other equivalent forms of the utility model, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

The above and other aspects, features and advantages of the present utility model will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings.

Specific embodiments of the present utility model will be described hereinafter with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the utility model, which can be embodied in various forms. Well-known and/or repeated functions and constructions are not described in detail to avoid obscuring the utility model in unnecessary or unnecessary detail.

Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present utility model in virtually any appropriately detailed structure.

The specification may use the word "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the utility model.

An embodiment of the present utility model relates to a contrast guidewire, as shown in fig. 1-3, fig. 1 shows a schematic structural view of the guidewire, fig. 2 shows a schematic sectional view of the guidewire at a Z-Z position, fig. 3 shows a partially enlarged schematic view of the guidewire, the guidewire comprises a core wire 1, the core wire 1 is a core part of the guidewire, and is located in an inner layer of the guidewire and extends from a proximal end of the guidewire to a distal end of the guidewire to a head end of the guidewire, wherein the proximal end refers to a part close to an operator, the distal end refers to a part far away from the operator, and the head end refers to an end position of the distal end, and the core wire 1 can be arranged in a round shape or a tip shape.

In particular, as further shown in fig. 1, the diameter of the core wire 1 may vary, for example, in one embodiment, the diameter of the core wire 1 decreases gradually from the proximal end to the distal end to the head end, such that the diameter of the head end of the core wire 1 is very small, providing good flexibility to the head end of the guide wire.

Further, the head end of the core wire 1 may be cone-shaped, parabolic, streamline-shaped or any other structure, the core wire 1 has high strength, the core wire 1 with high strength can provide good supporting force and pushing force for the guide wire, the core wire 1 may be made of any material suitable for being used as a guide wire, including but not limited to one of nickel-titanium alloy, 304 stainless steel, 316 stainless steel, cobalt-based alloy, fe-Mn alloy, cu-Zn alloy, fe-Ni alloy or Ti-Ni-X alloy, or of course, any two or more materials can be used, for example, stainless steel and nickel-titanium alloy materials are used for connection, and the connection is one or more of resistance welding, brazing, ultrasonic welding, laser welding, bonding and snap fit. For example, a nickel-titanium alloy may be used for the portion of the core wire 1 near the distal end, which has a high resistance to deformation, thereby providing the distal end of the guide wire with a high resistance to deformation, while stainless steel is used for the portion of the core wire 1 near the proximal end. The core wire 1 may be manufactured by physical grinding or chemical etching after the selection of the material.

As shown in fig. 1, the core wire 1 includes a first section and a second section, where the first section is a portion near the distal end of the guide wire, the second section is a portion near the proximal end of the guide wire, the first section is of a certain pre-bent shape, and is adapted to different clinical lesion requirements, and the second section is of a linear shape, so that the operation of a user is convenient.

Further, a spring ring sheath 4 for protecting the core wire 1 is arranged on the outer side of the first section, a safety net 3 is arranged between the core wire 1 and the spring ring sheath 4, the safety net 3 is arranged at a position close to the distal end of the core wire 1 and is jointly connected with the spring ring sheath 4 and the head end of the core wire 1, the safety net 3 and the spring ring sheath 4 are coaxially arranged, and the spring ring sheath 4 at least covers the whole part of the safety net 3.

Further, the spring coil sheath 4 is made of a developing spring and/or a stainless steel spring, and when the developing spring and the stainless steel spring are connected to each other, the connection may be one or more of resistance welding, soldering, ultrasonic welding, laser welding, adhesive bonding, and snap fitting. In one embodiment, the developing spring and the stainless steel spring are connected by laser welding to form the spring ring sheath 4, the current set in the manufacturing process is 80-100A, the pulse width is 4.0-6.0ms, the frequency is 6-8Hz, and the welding time is 1-5s.

For example, a part of the spring ring sheath 4 near the head end of the core wire 1 is made of a developing spring, preferably, the developing spring is made of at least one of platinum tungsten alloy, platinum nickel alloy, platinum iridium alloy, gold or other suitable materials, and the developing spring has good developing performance, enhances the visibility of the guide wire under the X-ray, and increases the success rate of the operation. Of course, 1-3 development marks may also be provided at the proximal end of the coil sheath 4, said development marks being used to indicate, for example, the position of the coil sheath 4.

Considering that if the safety net 3 is not provided at the head end of the guide wire but only the core wire 1 is provided, but the head end diameter of the core wire 1 is set very small, the head end of the guide wire can have good flexibility, but the core wire 1 at the head end is very thin and thus is easily broken, and the risk of breakage or falling off of the guide wire easily occurs in clinical use. However, when the diameter of the core wire 1 at the end of the guide wire is increased, the strength of the guide wire can be enhanced, and the risk of breakage or falling of the guide wire is avoided, but at the same time, the hardness of the end of the guide wire is increased, the softness of the end of the guide wire cannot be maintained, and the risk of perforation of blood vessels and the like due to the hard end of the guide wire is caused during clinical use.

The safety net 3 is sleeved on the head end of the core wire 1 and is connected with the head end of the core wire 1, in another embodiment, both ends of the safety net 3 are connected and fixed with the head end of the core wire 1, and the safety net 3 is made of metal wires in a hollow cylinder shape by weaving or metal pipe cutting and the like.

Furthermore, as shown in fig. 4 and 5, since the core wire 1, the safety net 3 and the coil sheath 4 are coaxially disposed and connected to each other, the core wire 1 can directly reach the head end of the guide wire, and the safety net 3 is sleeved on the head end, thus increasing the head end cross-sectional area of the guide wire. Thus, the safety net 3 is arranged at the head end of the core wire 1, the cross-sectional area of the head end of the guide wire can be increased, the breaking force of the guide wire is improved, meanwhile, the diameter of the tip end of the core wire 1 is reduced, the head end of the guide wire is kept to be flexible, the overall strength of the guide wire is enhanced, the shape of the safety net 3 is overlapped in a crossed mode, the safety net 3 is flexible in the radial direction, and the breaking force in the axial direction is high, so that the breaking and falling-off resistance of the head end of the guide wire can be enhanced, the safety of the head end is guaranteed, and the reliability is improved.

Here, the softness test is performed on the tip of the guide wire having the safety net 3, as shown in fig. 6, the guide wire is pushed by 10mm of the tip of the guide wire perpendicular to the balance, and the force applied to the guide wire by bending is the tip softness, and the harder the guide wire is, the softer is the larger the force value. Fig. 7 is a graph showing the results of the softness and breaking force test of the head end of the guide wire with/without the safety net, and as can be seen from fig. 7, when the guide wire is provided with no safety net 3, the soft head end of the guide wire is obtained (0.6 g), the breaking force is small (4N), the risk of breaking or falling off of the guide wire easily occurs in clinical use, and when the high breaking force is obtained (7N), the head end of the guide wire cannot simultaneously maintain softness (1.5 g), and the risk of vascular perforation and the like easily occurs in clinical use due to the hard head end of the guide wire; when the safety net 3 is arranged at the head end of the guide wire, the guide wire can obtain a soft head end (0.6 g, and the softness of the head end of the comparison is about 0.6 g) and can keep high breaking force (9N, and the breaking force of the comparison guide wire is about 7N);

when the safety net 3 is installed on the guide wire, the safety net 3 can be connected to any position on the head end of the core wire 1 according to requirements, for example, the distal end of the safety net 3 and the head end of the core wire 1 can be welded together in parallel.

In addition, the type, material, number of heads, size and location of the wires used in the safety net 3 may be tailored to the flexibility, safety, torque transmission, etc. requirements of the guide wire. During the process of manufacturing the safety net, the safety net 3 may be woven with wires according to different mesh densities (PPI) or different sizes according to different hardness requirements of the head end of the guide wire, where the wires may be round wires or flat wires, for example, when the head end of the guide wire is required to be harder, the head number and the cross-sectional size of the wires of the safety net 11 may be increased.

Specifically, the number of the metal wires of the safety net 3 is preferably 6-20, the diameter of the metal round wires is 0.0005-0.002, and the size of the metal flat wires is 0.0005-0.0005 x 0.002; furthermore, the longitudinal length of the safety net 3 is in the range of 10-50mm.

In a specific embodiment, the safety net 3 is formed by braiding at least 6 wires, the diameter of each wire is very small and can be about 1/4 of the diameter of the head end of the core wire 1 and is hollow and cylindrical, so that the safety net 3 in the radial direction is very soft, the head end of the guide wire can keep better softness through the safety net 3, and meanwhile, the safety net has higher breaking force in the axial direction, so that the risk of breakage or falling of the guide wire can be effectively avoided, and the safety of the head end is ensured.

Further, since the core wire 1, the safety net 3 and the spring ring sheath 4 at the head end of the guide wire are connected together, in consideration of circumferential rotation stability of the safety net 3, if the guide wire with the safety net 3 is placed in a twisted blood vessel, when the proximal end of the guide wire is rotated, torque feedback of 1:1 will be generated at the head end of the guide wire 1, torque/torque loss of the guide wire is reduced, and jump (tail flick) occurring at the head end of the guide wire during torque transmission is eliminated.

Further, a polymer jacket 2 is provided outside the second section, and a hydrophilic coating 5 is provided on the outer surface of the polymer jacket 2.

Further, the hydrophilic coating 5 is coated on a part or all of the surface of the polymer sheath 2, wherein the hydrophilic coating 5 is made of at least one of a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acrylate coating or a polymethyl vinyl ether-maleic anhydride coating, and the hydrophilic coating 5 provides the guide wire with very good lubricity and tracking performance, thereby reducing the passing resistance of the guide wire in a blood vessel and facilitating the pushing of the guide wire in the blood vessel.

The embodiment of the utility model solves the problem of safety of the end of the guide wire head, ensures that the end of the guide wire is soft, has higher breaking force, and simultaneously has excellent torsion control performance and deformation resistance, and particularly, has the requirements of the softness of the end, higher breaking force and excellent torsion control performance, and the hydrophilic coating on the surface ensures that the guide wire has good lubricity and tracking performance, and can comprehensively improve the comprehensive performance of the guide wire.

Moreover, although operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order. In certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the utility model. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are example forms of implementing the claims.

While various embodiments of the present utility model have been described in detail, the present utility model is not limited to these specific embodiments, and various modifications and embodiments can be made by those skilled in the art on the basis of the inventive concept, and these modifications and modifications should fall within the scope of the present utility model as claimed.

Claims (7)

1. The utility model provides a radiography seal wire, its includes the core silk, its characterized in that, the core silk is located the inlayer of seal wire and follow the proximal end of seal wire extends to the head end of seal wire, the core silk is including being certain preflex's first section and being the second section of straight line type the outside of first section sets up the spring ring sheath the core silk with set up the safety net between the spring ring sheath the outside of second section sets up the polymer sheath.

2. The contrast guidewire of claim 1, wherein the safety mesh is disposed proximate to a distal end of the core wire and is commonly connected to the spring coil sheath and a head end of the core wire.

3. The contrast guidewire of claim 1, wherein a hydrophilic coating is disposed on an outer surface of the polymer sheath.

4. The contrast guidewire of claim 1, wherein the tip of the core wire is any one of conical, parabolic, and streamlined.

5. The contrast guidewire of claim 1, wherein the core wire tapers in diameter from the proximal end to the head end.

6. The contrast guidewire of claim 1, wherein the safety mesh is made by braiding wires, either round wire or flat wire, into different mesh densities or different sizes.

7. The contrast guidewire of claim 1, wherein the spring loop sheath is made with a developing spring and/or a stainless steel spring.