Medical guide wire and manufacturing method thereof

Abstract

The application relates to the technical field of medical guide wires, and more particularly to a medical guide wire and a manufacturing method thereof. The medical guide wire comprises a guide wire body, a first spring and a second spring are sleeved on the guide wire body; a spring wire of the first spring comprises a first blocking end and a first embedding end, the first blocking end faces the guide wire body, the first embedding end is arranged in a direction away from the guide wire body, and the outer diameter of the first blocking end is larger than that of the first embedding end; the spring wire of the second spring is alternately arranged with the spring wire of the first spring, the spring wire of the second spring comprises a second blocking end and a second embedding end, the outer diameter of the second blocking end is larger than that of the second embedding end, the second blocking end is arranged in a direction away from the guide wire body, and the second embedding end faces the guide wire body; the distance between adjacent first blocking ends is smaller than the outer diameter of the second embedding end. The medical guide wire in the application can prevent the first spring and the second spring from slipping and mispositioning while ensuring sufficient restoring force.

Description

Technical Field

[0001] This invention relates to the technical field of medical guidewires, and more specifically, to a medical guidewire and its manufacturing method. Background Technology

[0002] In stroke treatment, medical guidewires are frequently used. During surgery, they are usually the first device to enter the blood vessel and reach the vicinity of the lesion. Then, other aspiration catheters, stents, or balloon catheters are slowly inserted along the direction of the guidewire and finally placed in place.

[0003] Traditional medical guidewires tend to bend significantly when passing through locations with a small radius of curvature in blood vessels. However, due to insufficient recovery force, they cannot fully return to their original state before bending, making it difficult for the guidewire to continue advancing in the blood vessel.

[0004] A medical guidewire with an externally fitted spring is provided. It consists of a metal inner core and a resin layer covering the metal inner core, and has a straight base and a curved front end. The outer diameter of the guidewire is 0.56mm-0.68mm, and the bending radius of the front end is 0.2mm-20mm. The guidewire also includes a spring fitted on the curved front end.

[0005] While the existing medical guidewires described above have improved their bending recovery capability to some extent, when passing through areas with a small radius of curvature in blood vessels, the spring wire at the inner bend of the guidewire may experience "slippage" or "misalignment" due to compression (see reference). Figure 1 However, when this happens, the spring wire may not be able to return to its original position, which weakens the effect of the spring in helping the medical guide wire to restore its shape.

[0006] There is also a type of medical guidewire with two springs fitted on the outside. While this type of guidewire greatly improves its recovery force from a bent state, when passing through blood vessels with a small radius of curvature, part of the inner spring wire at the inner bend of the guidewire is easily compressed and gets stuck in the gap between the outer spring wires (see reference). Figure 2 In such cases, the spring wire may fail to return to its original position, thus weakening the spring's ability to assist the medical guide wire in restoring its shape. Summary of the Invention

[0007] To overcome the problem of misalignment of the spring wires on the outside of existing guidewires, the present invention provides a medical guidewire.

[0008] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows: a medical guidewire, comprising a guidewire body, wherein a first spring and a second spring are sleeved on the guidewire body; the spring wire of the first spring includes a first blocking end and a first engaging end, the first blocking end facing the guidewire body, the first engaging end being arranged in a direction away from the guidewire body, and the outer diameter of the first blocking end being larger than the outer diameter of the first engaging end; the spring wire of the second spring is arranged alternately with the spring wire of the first spring, the spring wire of the second spring includes a second blocking end and a second engaging end, the outer diameter of the second blocking end being larger than the outer diameter of the second engaging end, the second blocking end being arranged in a direction away from the guidewire body, and the second engaging end facing the guidewire body; the distance between adjacent first blocking ends is smaller than the outer diameter of the second engaging end.

[0009] The second engaging end is inserted between two adjacent first blocking ends, allowing the first blocking ends to laterally block the second engaging end and prevent lateral misalignment due to compression. The outer diameter of the first blocking end is larger than that of the first engaging end, and the outer diameter of the second blocking end is larger than that of the second engaging end, making the spring wires of both the first and second springs wedge-shaped. Since the spring wires of the first and second springs are arranged alternately, and the first engaging end of the first spring and the second engaging end of the second spring face opposite directions, the first and second springs form a wedge structure that interlocks with each other. This prevents misalignment of either the first or second spring when it bends with the guide wire body. At the same time, the distance between adjacent first blocking ends is smaller than the outer diameter of the second engaging end, ensuring that the spring wire of the second spring will not get stuck in the first spring due to compression.

[0010] Furthermore, the cross-sectional shape of the spring wire of the first spring is the same as that of the cross-sectional shape of the spring wire of the second spring.

[0011] Furthermore, the cross-section of the spring wires of the first and second springs is triangular.

[0012] Furthermore, the cross-section of the spring wires of the first and second springs is trapezoidal.

[0013] Furthermore, the cross-section of the spring wires of the first and second springs is a Reichol triangle.

[0014] Furthermore, one end of the guide wire body is provided with a ball head, and the first spring and the second spring are both fixedly connected to the ball head.

[0015] Furthermore, the guide wire body is covered with an elastic layer, and both the first spring and the second spring are disposed within the elastic layer.

[0016] Furthermore, the outer surface of the elastic layer is provided with a hydrophilic coating.

[0017] Furthermore, the guidewire body includes a distal end, a proximal end, and a transition portion, with the distal end and proximal end respectively located at both ends of the transition portion; the outer diameter of the distal end is larger than the outer diameter of the proximal end, and the outer diameter of the transition portion gradually decreases along the direction from the distal end to the proximal end.

[0018] On the other hand, the present invention also provides a method for manufacturing a medical guidewire, comprising the following steps:

[0019] S1. Sleeve the first spring onto the guide wire body and fix the first spring onto the guide wire body;

[0020] S2. The second spring is sleeved on the guide wire body, so that the spring wire of the second spring is alternately arranged with the spring wire of the first spring, and the second spring is fixed on the guide wire body;

[0021] S3. Immerse the guidewire body, the first spring, and the second spring in the liquid polymer so that the liquid polymer wraps the guidewire body, the first spring, and the second spring. Then remove the guidewire body, the first spring, and the second spring from the liquid polymer and cool it until the liquid polymer solidifies to obtain a guidewire body with an elastic layer.

[0022] S4. Immerse the guidewire body with the elastic layer into the liquid hydrophilic coating so that the liquid hydrophilic coating covers the guidewire body with the elastic layer. Then remove the guidewire body with the elastic layer from the liquid hydrophilic coating and cool it until the liquid hydrophilic coating solidifies to obtain the medical guidewire.

[0023] Compared with the prior art, the beneficial effects of the present invention are:

[0024] 1. The second engaging end is inserted between two adjacent first blocking ends, allowing the first blocking ends to laterally block the second engaging end and prevent lateral misalignment due to compression. The outer diameter of the first blocking end is larger than that of the first engaging end, and the outer diameter of the second blocking end is larger than that of the second engaging end, making the spring wires of both the first and second springs wedge-shaped. Since the spring wires of the first and second springs are arranged alternately, and the first engaging end of the first spring and the second engaging end of the second spring face opposite directions, the first and second springs form a wedge structure that interlocks with each other. This prevents misalignment of either the first or second spring when it bends with the guide wire body. At the same time, the distance between adjacent first blocking ends is smaller than the outer diameter of the second engaging end, ensuring that the spring wire of the second spring will not get stuck in the first spring due to compression.

[0025] 2. The cross-section of the spring wire of the first spring is the same as that of the spring wire of the second spring, which enables the first spring and the second spring to fit together more tightly, and further prevents the spring wires of the first spring and the second spring from being misaligned during the bending process of the guide wire body;

[0026] 3. The cross-sections of the spring wires of the first and second springs are triangular, so that the contact parts of the spring wires of the first and second springs are all flat, thereby increasing the contact area of ​​the spring wires of the first and second springs, and thus increasing the friction between the first and second springs, thereby further reducing the misalignment of the spring wires of the first and second springs.

[0027] 4. The cross-section of the spring wires of the first spring and the second spring is a Reylow triangle, which can reduce the sharp edges of the spring wires of the first spring and the second spring, making the surface of the guide wire body with the first spring and the second spring more rounded, and avoiding damage to the blood vessels when the guide wire body with the first spring and the second spring travels in the blood vessels.

[0028] 5. By providing a ball head on the guidewire body, which serves as the front end of the guidewire body after it enters the blood vessel, it is possible to prevent the guidewire body from puncturing the blood vessel when passing through the curved parts of the blood vessel. Attached Figure Description

[0029] Figure 1 This is a diagram of the internal structure of a medical guidewire in existing technology;

[0030] Figure 2 This is a diagram of the internal structure of a medical guidewire in another existing technology;

[0031] Figure 3 This is a schematic diagram of the overall structure of a medical guidewire according to Embodiment 1 of the present invention;

[0032] Figure 4 This is a schematic diagram of the internal structure of a medical guidewire according to Embodiment 1 of the present invention;

[0033] Figure 5 This is an internal structural diagram of the guidewire body in a bent state in Embodiment 1 of the present invention;

[0034] Figure 6 This is a schematic diagram of the internal structure of the transition section in Embodiment 1 of a medical guidewire of the present invention;

[0035] Figure 7 This is a schematic diagram of the internal structure of a medical guidewire according to Embodiment 2 of the present invention;

[0036] Figure 8 This is a schematic diagram of the internal structure of a medical guidewire according to Embodiment 3 of the present invention.

[0037] In the attached figures: 1. Guide wire body; 11. Distal end; 12. Transition section; 13. Proximal end; 2. First spring; 21. First blocking end; 22. First engaging end; 3. Second spring; 31. Second blocking end; 32. Second engaging end; 4. Ball head; 5. Elastic layer; 6. Hydrophilic coating. Detailed Implementation

[0038] The accompanying drawings are for illustrative purposes only and should not be construed as limiting this patent. To better illustrate this embodiment, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings. The positional relationships described in the drawings are for illustrative purposes only and should not be construed as limiting this patent.

[0039] In the accompanying drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components. In the description of the present invention, it should be understood that if terms such as "upper," "lower," "left," "right," "long," and "short" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting the present patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0040] The technical solution of the present invention will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings:

[0041] Example 1

[0042] Reference Figures 3 to 6 This is an embodiment 1 of a medical guidewire of the present invention. The medical guidewire includes a guidewire body 1, on which a first spring 2 and a second spring 3 are sleeved. The spring wire of the first spring 2 includes a first blocking end 21 and a first engaging end 22. The first blocking end 21 faces the guidewire body 1, and the first engaging end 22 is arranged in a direction away from the guidewire body 1. The outer diameter of the first blocking end 21 is larger than the outer diameter of the first engaging end 22. The spring wire of the second spring 3 is alternately arranged with the spring wire of the first spring 2. The spring wire of the second spring 3 includes a second blocking end 31 and a second engaging end 32. The outer diameter of the second blocking end 31 is larger than the outer diameter of the second engaging end 32. The second blocking end 31 is arranged in a direction away from the guidewire body 1, and the second engaging end 32 faces the guidewire body 1. The distance between adjacent first blocking ends 21 is smaller than the outer diameter of the second engaging end 32.

[0043] The second engaging end 32 is inserted between two adjacent first blocking ends 21, and the first blocking end 21 can laterally block the second engaging end 32, preventing the second engaging end 32 from being misaligned due to compression. The outer diameter of the first blocking end 21 is larger than the outer diameter of the first engaging end 22, and the outer diameter of the second blocking end 31 is larger than the outer diameter of the second engaging end 32, so that the spring wires of the first spring 2 and the second spring 3 are both wedge-shaped. Since the spring wires of the first spring 2 and the second spring 3 are arranged alternately, and the first engaging end 22 of the first spring 2 and the second engaging end 32 of the second spring 3 are oriented in opposite directions, the first spring 2 and the second spring 3 form a wedge structure that is inserted into each other. This can prevent the first spring 2 or the second spring 3 from being misaligned when the guide wire body 1 bends. At the same time, the distance between adjacent first blocking ends 21 is smaller than the outer diameter of the second engaging end 32, which also ensures that the spring wire of the second spring 3 will not be stuck in the first spring 2 due to compression.

[0044] In this embodiment, the cross-sectional shape of the spring wire of the first spring 2 is the same as that of the spring wire of the second spring 3. This arrangement allows the first spring 2 and the second spring 3 to fit together more tightly, further preventing the spring wires of the first spring 2 and the second spring 3 from becoming misaligned during the bending process of the guide wire body 1.

[0045] In this embodiment, the cross-section of the spring wires of the first spring 2 and the second spring 3 is triangular.

[0046] Specifically, the cross-sections of the spring wires of the first spring 2 and the second spring 3 are both equilateral triangles. The base of the cross-section of the spring wire of the first spring 2 is the first blocking part, and the base of the cross-section of the spring wire of the second spring 3 is the second blocking part. This arrangement makes the cross-sections of the first spring 2 and the second spring 3 have serrations facing opposite directions, so that the contact parts of the spring wires of the first spring 2 and the second spring 3 are all flat. This increases the contact area of ​​the spring wires of the first spring 2 and the second spring 3, thereby increasing the friction between the first spring 2 and the second spring 3, and further reducing the misalignment of the spring wires of the first spring 2 and the second spring 3.

[0047] In this embodiment, one end of the guide wire body 1 is provided with a ball head 4, and the first spring 2 and the second spring 3 are both fixedly connected to the ball head 4.

[0048] Specifically, one end of the guidewire body 1 along its length is provided with a stainless steel ball head 4. The ball head 4 is hemispherical and is fixed to the guidewire body 1 by ultrasonic welding. The first spring 2 and the second spring 3 are both fixed to the bottom surface of the ball head 4 by welding. By providing the ball head 4 on the guidewire body 1, the ball head 4 serves as the front end of the guidewire body 1 after it enters the blood vessel, which can prevent the guidewire body 1 from puncturing the blood vessel when passing through the curved part of the blood vessel.

[0049] In this embodiment, the guide wire body 1 is covered with an elastic layer 5, and the first spring 2 and the second spring 3 are both disposed within the elastic layer 5.

[0050] Specifically, the first spring 2 and the second spring 3 are embedded in the elastic layer 5. The elastic layer 5 can be made of TPU or PTFE. By setting the elastic layer 5, the first spring 2 and the second spring 3 can be prevented from being exposed to the outside, thereby making the surface of the guidewire body 1 relatively flat and smooth, thus preventing the guidewire body 1 from scratching the blood vessel when it travels in the blood vessel.

[0051] In this embodiment, the outer surface of the elastic layer 5 is provided with a hydrophilic coating 6.

[0052] Specifically, in this embodiment, the hydrophilic coating 6 is made of Hydromer EF50L material. By setting the hydrophilic coating, the catheter can travel more smoothly and stably in blood vessels when it reaches locations with aneurysms, thrombi, etc.

[0053] In this embodiment, the guidewire body 1 includes a distal end 11, a proximal end 13, and a transition portion 12. The distal end 11 and the proximal end 13 are respectively disposed at both ends of the transition portion 12. The outer diameter of the distal end 11 is larger than the outer diameter of the proximal end 13, and the outer diameter of the transition portion 12 gradually decreases along the direction from the distal end 11 to the proximal end 13.

[0054] Specifically, one end of the first spring 2 is fixed to the ball head 4, and the other end is fixed to the transition portion 12. One end of the second spring 3 is fixed to the ball head 4, and the other end is fixed to the transition portion 12. In this way, the first spring 2, the second spring 3, and the guidewire body 1 can be fixed relative to each other. The outer diameter of the proximal end 13 is smaller, so the proximal end 13 is used for probing into the blood vessel, and the distal end 11 is used for the operator to hold and operate.

[0055] Example 2

[0056] Reference Figure 8 This is a second embodiment of a medical guidewire of the present invention. The difference between this embodiment and embodiment 1 is that the cross-section of the spring wires of the first spring 2 and the second spring 3 is trapezoidal.

[0057] Example 3

[0058] Reference Figure 7 This is a third embodiment of a medical guidewire of the present invention. The difference between this embodiment and embodiment 1 is that the cross-section of the spring wires of the first spring 2 and the second spring 3 is a Reichelk triangle. This arrangement can reduce the sharp edges of the spring wires of the first spring 2 and the second spring 3, making the surface of the guidewire body 1 with the first spring 2 and the second spring 3 more rounded, and avoiding damage to the blood vessels when the guidewire body 1 with the first spring 2 and the second spring 3 travels in the blood vessels.

[0059] Example 4

[0060] This embodiment describes a method for manufacturing a medical guidewire according to Embodiment 1 of the present invention, comprising the following steps:

[0061] S1. The first spring 2 is sleeved on the guide wire body 1, and one end of the first spring 2 is welded to the ball head 4, and the other end is welded to the transition part 12;

[0062] S2. The second spring 3 is sleeved on the guide wire body 1, so that the spring wire of the second spring 3 and the spring wire of the first spring 2 are alternately arranged, and one end of the second spring 3 is welded to the ball head 4 and the other end is welded to the transition part 12.

[0063] S3. Immerse the guidewire body 1, the first spring 2, and the second spring 3 in liquid TPU, so that the liquid TPU wraps the guidewire body 1, the first spring 2, and the second spring 3. Then remove the guidewire body 1, the first spring 2, and the second spring 3 from the liquid TPU and cool them until the liquid polymer solidifies to obtain the guidewire body 1 with the elastic layer 5.

[0064] S4. Immerse the guidewire body 1 with the elastic layer 5 into the liquid hydrophilic coating so that the liquid hydrophilic coating wraps the guidewire body 1 with the elastic layer 5. Then remove the guidewire body 1 with the elastic layer 5 from the liquid hydrophilic coating and cool it until the liquid hydrophilic coating solidifies to obtain the medical guidewire.

[0065] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A medical guidewire, comprising a guidewire body (1), wherein a first spring (2) and a second spring (3) are sleeved on the guidewire body (1); characterized in that, The spring wire of the first spring (2) includes a first blocking end (21) and a first engaging end (22). The first blocking end (21) faces the guide wire body (1), and the first engaging end (22) is arranged in a direction away from the guide wire body (1). The outer diameter of the first blocking end (21) is larger than the outer diameter of the first engaging end (22). The spring wire of the second spring (3) is arranged alternately with the spring wire of the first spring (2). The spring wire of the second spring (3) includes a second blocking end (31) and a second engaging end (32). The outer diameter of the second blocking end (31) is larger than the outer diameter of the second engaging end (32). The second blocking end (31) is arranged in a direction away from the guide wire body. (1) The orientation setting is such that the second fitting end (32) faces the guide wire body (1), so that the first spring (2) and the second spring (3) form a wedge structure that is inserted into each other, so as to avoid the first spring (2) and the second spring (3) from being misaligned when the guide wire body (1) bends; the distance between adjacent first blocking ends (21) is less than the outer diameter of the second fitting end (32), so as to ensure that the spring wire of the second spring (3) will not be squeezed and stuck in the first spring (2); the guide wire body (1) is covered with an elastic layer (5), and the first spring (2) and the second spring (3) are both located in the elastic layer (5).

2. The medical guidewire according to claim 1, characterized in that, The cross-section of the spring wire of the first spring (2) has the same cross-sectional shape as that of the spring wire of the second spring (3).

3. The medical guidewire according to claim 2, characterized in that, The cross-section of the spring wires of the first spring (2) and the second spring (3) is triangular.

4. The medical guidewire according to claim 2, characterized in that, The cross-sections of the spring wires of the first spring (2) and the second spring (3) are trapezoidal.

5. The medical guidewire according to claim 2, characterized in that, The cross-section of the spring wires of the first spring (2) and the second spring (3) is a Reilly triangle.

6. The medical guidewire according to claim 1, characterized in that, One end of the guide wire body (1) is provided with a ball head (4), and the first spring (2) and the second spring (3) are both fixedly connected to the ball head (4).

7. The medical guidewire according to claim 1, characterized in that, The outer surface of the elastic layer (5) is provided with a hydrophilic coating (6).

8. The medical guidewire according to claim 1, characterized in that, The guidewire body (1) includes a distal end (11), a proximal end (13), and a transition portion (12). The distal end (11) and the proximal end (13) are respectively located at both ends of the transition portion (12). The outer diameter of the distal end (11) is larger than the outer diameter of the proximal end (13), and the outer diameter of the transition portion (12) gradually decreases along the direction from the distal end (11) to the proximal end (13).

9. A method for manufacturing a medical guidewire as described in any one of claims 1-8, characterized in that, The process includes the following steps: S1. The first spring (2) is sleeved on the guide wire body (1) and fixed on the guide wire body (1); S2. The second spring (3) is sleeved on the guide wire body (1) such that the spring wire of the second spring (3) and the spring wire of the first spring (2) are alternately arranged, and the second spring (3) is fixed on the guide wire body (1); S3. The guide wire body (1), the first spring (2), and the second spring (3) are all immersed in the liquid polymer, so that the liquid polymer wraps the guide wire body (1), the first spring (2), and the second spring (3), and then the guide wire body (1), the first spring (2), and the second spring (3) are removed from the liquid polymer and cooled until the liquid polymer solidifies, thus obtaining the guide wire body (1) with the elastic layer (5); S4. Immerse the guidewire body (1) with the elastic layer (5) into the liquid hydrophilic coating so that the liquid hydrophilic coating wraps the guidewire body (1) with the elastic layer (5), then remove the guidewire body (1) with the elastic layer (5) from the liquid hydrophilic coating, and then cool it until the liquid hydrophilic coating solidifies to obtain the medical guidewire.

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