A core wire assembly for a guide wire, a guide wire and a guide wire system

Abstract

The application provides a core wire assembly for a guide wire, a guide wire and a guide wire system. The core wire assembly comprises one or more layers of first coil elements and a shape setting element, at least one of the one or more layers of first coil elements comprises a plurality of first spring coils coaxially arranged along a central axis, the spring wires of the plurality of first spring coils are arranged side by side along a circumferential direction around the central axis and extend spirally around the central axis, and the plurality of first spring coils have the same pitch and the same spiral radius. The one or more layers of first coil elements are sleeved outside the shape setting element. The core wire assembly of the application can greatly increase the torsional rigidity of the core wire assembly without changing the surface properties of the existing core wire assembly, so that the types of guide wires available for operators to choose are more diverse to meet various surgical needs.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more specifically, to a core wire assembly, a guide wire, and a guide wire system for use with a guide wire. Background Technology

[0002] With the development of medical technology, interventional therapy has become an important treatment method. Interventional therapy is a general term for a series of techniques that use puncture needles, catheters, and other interventional devices to insert specific instruments into the diseased area of ​​the body through natural orifices or tiny incisions for minimally invasive treatment. During interventional therapy, guidewires, as an important interventional device, can guide other devices such as stents.

[0003] In many medical procedures, monitoring and analyzing various physiological parameters within a patient's body allows for the development of more rational treatment plans. These parameters are typically physical, such as pressure, temperature, and flow rate. Since these parameters cannot be obtained from outside the patient's body, sensors can be mounted on guidewires and positioned in the bloodstream via the guidewires for safe, reliable, and accurate monitoring. The guidewires can then position the sensors within a living blood vessel to detect these physiological parameters.

[0004] Guidewire dimensions are subject to strict limitations; excessively thick guidewires struggle to pass through narrow blood vessels, hindering the application of some guidewire-guided devices. For guidewires meeting the required dimensions, several interdependent physical parameters influence their performance, such as flexibility, support, and torsional stiffness. Increasing guidewire flexibility allows for easier bending and passage through tortuous vessel segments, but may reduce support, making advancement difficult under significant resistance. Torsional stiffness is also related to flexibility; increased flexibility may hinder the transmission of torque from the proximal end to the distal end. Currently, commercially available guidewires exhibit poor distal torsional stiffness, necessitating a more optimized guidewire structure for easier operator use. Utility Model Content

[0005] To at least partially address the problems existing in the prior art, one aspect of this application provides a core wire assembly for a guide wire, comprising: one or more first coil elements with a central axis as the axis, at least one of the one or more first coil elements including multiple strands of first spring coils coaxially arranged with the central axis as the axis, the spring wires of the multiple strands of first spring coils being arranged side by side along the circumferential direction around the central axis and extending spirally around the central axis, the multiple strands of first spring coils having the same pitch and spiral radius; and a shaping element, the one or more first coil elements being sleeved on the outside of the shaping element.

[0006] For example, the core wire assembly also includes one or more outer layer elements disposed outside one or more first coil elements.

[0007] For example, one or more outer layer elements include one or more of a second coil element, a hysteresis tube, and a braided tube.

[0008] For example, the core wire assembly also includes one or more intermediate layer elements disposed between the first coil element and the shaping element.

[0009] For example, one or more intermediate layer elements include one or more of a second coil element, a hysteresis tube, and a braided tube.

[0010] For example, the second coil element includes a single-strand spring coil.

[0011] For example, the second coil element includes multiple strands of second spring coils, the spring wires of which are arranged side by side along a circumferential direction around a central axis and extend spirally around the central axis, the multiple strands of second spring coils having the same pitch and spiral radius.

[0012] For example, the shaping element includes a shaping segment and a connecting segment, both extending along a central axis. The connecting segment is connected to the proximal end of the shaping segment and is used to connect to a push tube, which is sleeved on the shaping segment.

[0013] For example, the shaping segment includes a first sub-segment and a second sub-segment that both extend along a central axis. The second sub-segment is connected between the first sub-segment and the connecting segment. The second sub-segment has a decreasing cross-sectional area along the direction from the distal end. The first sub-segment is flat and has a first dimension along the thickness direction of the first sub-segment. The distal end of the second sub-segment has a second dimension, and the first dimension is smaller than the second dimension.

[0014] For example, the distal ends of the spring wires of the multi-strand first spring coil are flush.

[0015] For example, the proximal ends of the spring wires of the multi-strand first spring coil are flush.

[0016] For example, each strand of the multi-strand first spring coil does not contact each other.

[0017] Exemplarily, the core wire assembly further includes: a guide element disposed at the distal end of one or more first coil elements, the guide element having a curved outer surface and a decreasing outer diameter along the direction toward the distal end.

[0018] This application also provides a guidewire, comprising: an elongated and hollow push tube; a detector disposed inside the distal end of the push tube; and the aforementioned core wire assembly connected to the distal end of the push tube.

[0019] For example, the push tube includes a hysteresis tube.

[0020] This application also provides a guidewire system, including the guidewire described above; and a host computer, wherein the detector is connected to the host computer via an optical fiber.

[0021] Therefore, by incorporating multiple first spring coils, the torsional force acting on a single spring wire can be distributed across the multiple spring coils, significantly improving torsional rigidity while maintaining the same wire diameter. Each strand of the multiple first spring coils engages with each other through small gaps, preventing gaps on the surface of the core wire assembly that are larger than those in existing core wire assemblies. Furthermore, the outer diameter of each first spring coil is identical, allowing the overall core wire assembly to have the same outer diameter as existing core wire assemblies. In summary, the core wire assembly of this application can significantly increase the torsional rigidity of the core wire assembly without altering its surface properties, thus providing operators with a wider variety of guidewires to suit diverse surgical needs.

[0022] This utility model description introduces a series of simplified concepts, which will be further explained in detail in the detailed description section. This utility model description is not intended to limit the key features and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.

[0023] The advantages and features of this utility model will be described in detail below with reference to the accompanying drawings. Attached Figure Description

[0024] The above and other objects, features, and advantages of this application will become more apparent from the more detailed description of the embodiments of this application in conjunction with the accompanying drawings. The accompanying drawings are used to provide a further understanding of the embodiments of this application and form part of the specification. They are used together with the embodiments of this application to explain this application and do not constitute a limitation thereof. In the accompanying drawings, the same reference numerals generally represent the same components or steps.

[0025] Figure 1A A perspective view of a guidewire according to an embodiment of the present invention is shown;

[0026] Figure 1B It shows Figure 1A A partial enlarged view of the guidewire in the illustrated embodiment;

[0027] Figure 2A It shows that according to Figure 1A A cross-sectional view of the guidewire in the illustrated embodiment;

[0028] Figure 2B It shows that according to Figure 2A A partially enlarged cross-sectional view of the guidewire in the illustrated embodiment;

[0029] Figure 3A cross-sectional view of a core wire assembly according to an embodiment of the present invention is shown;

[0030] Figure 4A It shows that according to Figure 3 A perspective view of the first coil element of the core wire assembly in the illustrated embodiment;

[0031] Figure 4B It shows that according to Figure 4A A cross-sectional view of the first coil element in the illustrated embodiment;

[0032] Figure 4C It shows that according to Figure 4A Front view of the first coil element in the illustrated embodiment;

[0033] Figure 5 It shows that according to Figure 4A A perspective view of a first spring coil in the first coil element of the illustrated embodiment;

[0034] Figure 6 A perspective view of a first coil element according to another exemplary embodiment of this application is shown;

[0035] Figures 7-12 Cross-sectional views of the core wire assembly according to different exemplary embodiments of this application are shown respectively.

[0036] The above figures include the following reference numerals:

[0037] 100. Push tube; 110. Detector opening; 200. Core wire assembly; 210. First coil element; 211. First spring coil; 212. Slit; 220. Shaping element; 221. Shaping section; 2211. First sub-segment; 2212. Second sub-segment; 222. Connecting section; 230. Outer layer element; 240. Middle layer element; 250. Second coil element; 260. Hypotube; 270. Guide element; 300. Detector; 400. Optical fiber. Detailed Implementation

[0038] In the following description, numerous details are provided to enable a thorough understanding of this application. However, those skilled in the art will appreciate that the following description merely illustrates preferred embodiments of the application by way of example only. Furthermore, to avoid confusion with this application, some technical features well-known in the art have not been described in detail.

[0039] This application provides a guidewire, such as Figure 1A and Figure 1BAs shown, the guidewire may include a slender and hollow push tube 100 and a core wire assembly 200 disposed at the distal end of the guidewire. In this application, "proximal end" and "distal end" refer to the end of the guidewire closest to the operator and the end furthest from the operator, respectively. The guidewire diameter is typically around 0.3 mm, and its length may be greater than 1800 mm, allowing it to enter the blood vessel from the femoral or radial artery and ultimately reach the target location. Therefore, the guidewire has a very large aspect ratio. For ease of understanding, only key portions of the guidewire are shown in the figure, and the proportions illustrated do not represent the proportions of the actual guidewire. Optionally, the push tube 100 may include a spring tube, a hollow steel tube, a hypo tube, or any two or more of the above three types. Spring tubes offer good flexibility and support, but relatively lower torsional stiffness compared to the other two. Spring tubes may include a single-strand spring tube or a multi-strand spring tube wound with multiple springs. Hollow steel tubes have a simple structure, low cost, and high support and torsional stiffness, but poor flexibility. The push tube of the sodium hypochlorite tube (HHTV) has good torsional rigidity. Taking the common cut-type HHTV tube as an example, different textures are cut into the surface of the hollow steel tube to improve its radial flexibility without affecting the transmission of axial force. In summary, each of the above three components has its advantages and disadvantages. One of them, or two or three in combination, can be used to achieve the desired physical properties. Figure 2A and Figure 2B As shown, the guidewire may also include a detector 300, which is disposed inside the distal end of the push tube 100. The detector 300 may include a sensor for detecting intravascular pressure, such as a fiber optic pressure detector 300. The push tube 100 may have a detector opening 110 exposing the detector 300. Optionally, the detector 300 may also be configured to detect physical quantities such as blood flow velocity and blood flow rate. The wiring of the detector 300, such as an optical fiber 400, can extend to the proximal end through the lumen of the hollow push tube 100. The guidewire also includes a core wire assembly 200, which can act as a guide within the blood vessel. The flexibility of the core wire assembly 200 and the push tube 100 gradually increases from the proximal end to the distal end, thereby providing strong support for the guidewire proximally while allowing for easy bending at the distal end, thus navigating various tortuous vascular environments. The core wire assembly 200, in conjunction with the push tube 100, guides the detector 300 to a designated location to collect data from the affected area.

[0040] As described above, the push tube 100 may, exemplarily, include a sodium hypochlorite tube. The sodium hypochlorite tube exhibits good torque transmission performance while also providing relatively strong support. Combined with the core wire assembly 200, which has high torsional stiffness and is mentioned below, the guide wire as a whole possesses greater torsional stiffness. Such a guide wire can be applied to some special application scenarios.

[0041] This application also provides a core wire assembly 200 for the aforementioned guide wire. For example...Figure 3 As shown, the core wire assembly 200 includes one or more first coil elements 210 with a central axis as the axis, and at least one of the one or more first coil elements 210 includes multiple strands of first spring coils 211 coaxially arranged with the central axis as the axis. Specifically, the core wire assembly 200 may include only one first coil element 210, which is a multiple strand of first spring coils 211. The core wire assembly 200 may include multiple layers of first coil elements 210. Optionally, the multiple layers of first coil elements may include one layer of multiple strands of first spring coils 211 and multiple layers of single-strand spring coils; alternatively, the multiple layers of first coil elements may include multiple layers of multiple strands of first spring coils 211 and one layer of single-strand spring coils; alternatively, each layer of the multiple layers of first coil elements is a multiple strand of first spring coils 211. The spring wires of the multiple strands of first spring coils 211 are arranged side by side along the circumferential direction around the central axis and extend spirally around the central axis. The multiple strands of first spring coils 211 have the same pitch and spiral radius. (Refer to reference...) Figures 4A-5 , Figure 4A A perspective view of an exemplary multi-strand first spring coil 211 is shown. Figure 4B The cross-section of the multi-strand first spring coil 211 is shown. Figure 4C The side view of the multi-strand first spring coil 211 is shown. Figure 5 The diagram shows one of the multiple first spring coils 211. It should be understood that the pitch of one first spring coil 211 may not be less than the sum of the wire diameters of the multiple first spring coils 211. When the multiple first spring coils 211 are wound coaxially, adjacent first spring coils 211 form only a small gap 212 between them. Figures 4A-4C The multi-strand first spring coil 211 shown is formed of 5 strands of spring wire; in embodiments not shown, it may also be formed of more or fewer strands of spring wire. Figure 6 As shown, the first coil element 210 can be stacked. In the stacked first coil assembly, the two layers of multi-strand first spring coils 211 can have opposite helical directions, thereby having similar torsional stiffness in both the forward and reverse directions.

[0042] Optionally, each of the multi-strand first spring coils 211 can be kept in close contact by a certain preload, thus forming an integral structure. Optionally, each of the first spring coils 211 can be non-contacting, thus forming a certain gap 212. The multi-strand first spring coils 211 can evenly distribute stress when subjected to external loads, improving their load-bearing capacity and stability. The elastic deformation capacity of the multi-strand first spring coils 211 in both the axial and radial directions is superior to that of a single-strand spring coil of the same wire diameter. The multi-strand first spring coils 211 can undergo elastic deformation within a certain range and return to their original shape after the external force disappears. Even if one of the multi-strand first spring coils 211 breaks, the other first spring coils 211 can hold it in place, preventing the entire spring coil from failing. This facilitates timely detection and safe removal by the operator for replacement with a new guide wire. When each of the first spring coils in the multi-strand first spring coil is non-contacting, the radius of the spiral wire can be adjusted... Steel wire helix angle Number of spring strands This is to achieve stiffness adjustment of multi-strand Bourdon tubes.

[0043] Return to reference Figure 4B With the material and the total axial length of the spring remaining unchanged,

[0044] The bending stiffness of a single-layer multi-strand spring satisfies:

[0045]

[0046] Torsional stiffness satisfies:

[0047]

[0048] in It is the stiffness constant. Let be the Poisson's ratio of the spring wire.

[0049] From the above formula, we know that the radius of the steel wire The greater the bending and torsional stiffness of the spring, the greater the helix angle. The larger the diameter, the greater the axial clearance of the steel wire, and the greater the bending and torsional stiffness of the spring; the more spring strands, the greater the bending and torsional stiffness of the spring.

[0050] The core wire assembly 200 may further include a shaping element 220, with one or more first coil elements 210 sleeved on the outside of the shaping element 220. Optionally, the shaping element 220 includes a tapered tubular or rod-like structure, the distal end of which can be bent and held in a bent state under external force. During guidewire insertion into the human body, the distal end of the guidewire needs to enter the correct vascular branch at the bifurcation of the blood vessel to reach the affected area. By rotating the proximal end of the guidewire, torque is transmitted along the guidewire to the distal end, causing the bent portion of the distal end of the guidewire to face the direction of the blood vessel to be entered. Optionally, the shaping element 220 may be flattened at its distal end, so that the force required to bend it in different radial directions varies, thereby facilitating bending in one direction.

[0051] Therefore, by setting up multiple first spring coils 211, the torsional force acting on a single spring wire can be distributed across multiple spring coils, significantly improving torsional rigidity while maintaining the same wire diameter. Each strand of the multiple first spring coils 211 is fitted together with a small gap, preventing gaps 212 on the surface of the core wire assembly 200 that are larger than those in existing core wire assemblies 200. Furthermore, the outer diameter of each first spring coil 211 is the same, allowing the overall outer diameter of the core wire assembly 200 to be consistent with existing core wire assemblies 200. In summary, the core wire assembly 200 of this application can significantly increase the torsional rigidity of the core wire assembly 200 without altering the surface properties of existing core wire assemblies 200, thus providing operators with a wider variety of guidewires to suit different surgical needs.

[0052] Exemplarily, the core wire assembly also includes one or more outer layer elements 230 disposed outside one or more first coil elements 210. Without changing the wire diameter, the flexibility of the first coil element 210 can be altered by changing its outer diameter. Based on this, one or more outer layer elements 230 can be disposed outside the first coil element 210 to change the physical properties of the core wire assembly 200 in terms of flexibility, torsional stiffness, support, and maneuverability. Exemplarily, the one or more outer layer elements 230 may include one or more of a second coil element 250, a hyaluronic acid tube 260, and a braided tube. (Refer to reference...) Figure 7 and Figure 8 The outer element 230 includes a second coil element 250. For example... Figure 7 As shown, the second coil element 250 of the core wire assembly 200A may include a multi-strand second spring coil. The spring wires of the multi-strand second spring coil are arranged side by side along the circumferential direction around the central axis and extend spirally around the central axis. The multi-strand second spring coils have the same pitch and helical radius. The advantages of the multi-strand second spring coil are the same as those of the multi-strand first spring coil 211, and will not be repeated here. Figure 8As shown, optionally, the second coil element 250 of the core wire assembly 200B may include a single-strand spring coil. Single-strand spring coils have a simple structure and low cost, but their torsional rigidity is relatively poor. Optionally, the second coil element 250 may also include more than one layer of single-strand spring coils, or more than one layer of multi-strand second spring coils. Optionally, the second coil element 250 may also combine multi-strand second spring coils with single-strand spring coils. It should be noted that the cross-sections of multi-strand second spring coils and single-strand spring coils are almost indistinguishable; therefore, for the second spring coil, this application… Figures 7-11 Each layer of the second spring coil shown can be considered as a multi-strand second spring coil or a single-strand spring coil. Similarly, this application... Figures 7-11 Each layer of the first spring coil shown can be either a multi-strand first spring coil or a single-strand spring coil, but at least one layer of multi-strand first spring coils is included in one or more layers of first spring coils.

[0053] For example Figure 9 As shown, in the embodiment where a sodium hypochlorite tube 260 is used as the outer layer element 230 of the core wire assembly 200C, the torsional stiffness of the core wire assembly 200 can be further improved, while the loss of flexibility is relatively small. In the embodiment where a braided tube is used as the outer layer element 230, the braided tube exhibits good compressive strength, torsional stiffness, toughness, and tensile strength. In embodiments not shown, the outer layer element 230 may also include a combination of the aforementioned outer layer elements 230.

[0054] Therefore, by rationally combining different outer element 230s, a core wire assembly 200 with superior performance in different aspects can be obtained. The operator can select a guidewire with a core wire assembly 200 that offers more suitable performance based on the patient's condition.

[0055] In the embodiments of the above-described core wire assembly 200A / 200B / 200C that include the outer layer element 230, the first coil element 210 is equivalent to being the inner layer of the core wire assembly, and the outer surface of the core wire assembly is formed by the outer layer element 230. Thus, the core wire assembly 200 includes the innermost shaping element 220, the middle layer of the first coil element 210, and the outermost outer layer element 230. Exemplarily, the core wire assembly 200 may also include one or more middle layer elements 240 disposed between the first coil element 210 and the shaping element 220. In this case, the core wire assembly 200 still includes three layers: the innermost shaping element 220, the middle layer elements 240, and the outermost first coil element 210.

[0056] For example, one or more intermediate layer elements 240 include one or more of a second coil element 250, a sodium hypotube 260, and a braided tube. Figure 10As shown, the middle element 240 of the core assembly 200D can be a sodium hypochlorite tube 260. Figure 11 In the middle layer element 240 of the core wire assembly 200D, a second coil element 250 is used. Since the second coil element 250 may also include multiple strands of second spring coils, the cross-sectional views of the first spring coil and the second spring coil are identical. Figure 11 and Figure 9 The filament assemblies 200B and 200D shown are almost identical. Figure 11 In the illustrated embodiment, the first coil element employs a single layer of multi-strand first spring coil. Figure 12 In the core wire assembly 200E, while the middle layer element 240 employs a multi-strand second spring coil, the outer first coil element 210 can employ a multi-layer multi-strand first spring coil. By properly configuring the middle layer element 240, the guide wire can achieve the desired performance.

[0057] For example, the shaping element 220 includes a shaping segment 221 and a connecting segment 222, both extending along a central axis. The connecting segment 222 is connected to the proximal end of the shaping segment 221 and is used to connect to the push tube 100, which is sleeved on the shaping segment 221. As shown, the shaping segment 221 has a relatively small diameter, thus exhibiting good flexibility and being able to bend and maintain its shape under stress when subjected to a large external force. The outer diameter of the push tube 100 is close to the outer diameter of the core wire assembly 200, and for better flexibility, the wall thickness of the push tube 100 is small, resulting in a relatively large inner diameter. The connecting segment 222 can be configured with a thinner distal end and a thicker proximal end, allowing the thicker proximal end to mate with the push tube 100, which has a larger inner diameter. This allows the core wire assembly 200 to be reliably connected to the delivery tube 100, and the shaping element 220 can be bent with instrument assistance or manually, allowing the distal end of the core wire assembly 200 to form the shape required for the surgery. The thinner and thicker portions of the connecting section 222 of the shaping element 220 can transition smoothly, preventing stress concentration and the formation of easily breakable edges. The thicker portion of the connecting section 222 matches the larger inner diameter of the delivery tube 100, making the connection more reliable and less prone to separation. Optionally, the connecting section 222 can be connected to the delivery tube 100 using processes such as adhesives, interference fits, or welding.

[0058] Exemplarily, the shaping segment 221 includes a first sub-segment 2211 and a second sub-segment 2212, both extending along a central axis. The second sub-segment 2212 connects the first sub-segment 2211 and the connecting segment 222, and has a decreasing cross-sectional area along the direction toward the distal end. As described above, for the guidewire, the flexibility gradually increases from the proximal end to the distal end, resulting in better proximal support performance, facilitating guidewire delivery, and better distal flexibility, enabling passage through tortuous blood vessels. The second sub-segment 2212 with a gradually decreasing cross-sectional area can be formed by spinning, grinding, or other methods to achieve the performance of gradually increasing flexibility from the proximal end to the distal end. The first sub-segment 2211 is flat, and along the thickness direction of the first sub-segment 2211, the first sub-segment 2211 has a first dimension, and the distal end of the second sub-segment 2212 has a second dimension, where the first dimension is smaller than the second dimension. Optionally, the first sub-segment 2211 can be processed from the second sub-segment 2212 by processes such as stamping, which reduces processing costs. Before processing, the first segment 2211 can have a tendency to continue decreasing in diameter towards the distal end, so that after being processed into a flat shape, it has a cross-sectional area no larger than that of the second segment. This maintains that the flexibility at the distal end is no greater than that at the proximal end, avoiding any abnormal tactile sensation for the operator. Figure 3 In the cross-sectional view shown, looking directly at the surface in the width direction of the first segment, since the first segment 2211 is machined from the second segment 2212, the thickness is reduced without abrupt changes in the cross-sectional area, thus making the dimension in the width direction larger than the dimension of the second segment 2212. (Return to Reference) Figure 2B As can be seen, in the thickness direction, the thickness of the first segment 2211 is significantly smaller than that of the second segment 2212. The width of the first segment 2211 is greater than its thickness, making its flexibility in the thickness direction much smaller than its flexibility in the width direction. This makes the first segment 2211 easy to bend in the thickness direction and maintain its bent shape. During use, the greater flexibility in other directions prevents the core wire assembly 200 from bending in undesirable directions.

[0059] For example, the distal ends of the spring wires in the multi-strand first spring coil 211 are flush. Optionally, the distal ends of the spring wires in the multi-strand first spring coil 211 can be cut by laser cutting, grinding, or other methods to form multiple core wire assemblies 200. Optionally, the flush surface can also be formed by laser cutting, grinding, or other methods. The flush distal surface can fit well with the surface of the guide assembly described below, and no obvious gaps 212 will be generated on the surface of the core wire assembly 200, so that the force that the multi-strand first spring coil 211 of the core wire assembly 200 can withstand in all directions is relatively uniform. In this way, the bending of the core wire assembly 200 is mainly affected by the shaping element 220, and the bending is more stable and reliable. The flush distal spring wires can limit each other, and one of them will not be raised to form a burr. For example, the proximal ends of the spring wires in the multi-strand first spring coil 211 can also be flush. In this way, the near end of the multi-strand first spring coil 211 can form a good fit with the push tube 100 mentioned below. Its advantages are similar to those of the far end of the multi-strand first spring coil 211 being flush with each other, and will not be repeated here.

[0060] Return to reference Figure 4B and Figure 4C For example, each strand of the multi-strand first spring coil does not contact each other. To achieve this effect, the multi-strand first spring coil 211 satisfies the following condition:

[0061]

[0062] in: This is the minimum distance from the spring wire to the central axis. Let be the radius of the spring wire. The number of strands in the multi-strand first spring coil. The helix angle of the spring wire.

[0063] As described above, in a multi-strand first spring coil, one first spring coil 211 is tightly fitted with its adjacent first spring coil, requiring the pitch of one first spring coil to accommodate the other first spring coils with the same helix angle and wire diameter. It should be noted that, ideally, each of the multi-strand first spring coils satisfying the above formula has a gap with each of its two adjacent first spring coils, preventing them from contacting each other. However, in practical use, for any one of the first spring coils, there may be a large gap between it and one of its adjacent first spring coils, leading to contact with the other adjacent first spring coil.

[0064] Exemplarily, the core wire assembly 200 may further include a guide element 270 disposed at the distal end of one or more first coil elements 210. The outer surface of the guide element 270 is curved and has a decreasing outer diameter along the direction toward the distal end. The outer diameter of the guide element 270 may be slightly larger than the outer diameter of the first coil element 210, thereby avoiding the formation of a sharp step between the first coil element 210 and the guide element 270 that could cause damage to the blood vessel during use. The guide element 270 may be connected to the distal end of the shaping element 220, and in the event of bending of the shaping element 220, the guide element 270 forms an angle with other parts of the guide wire positioned by the shaping element 220. The curved outer surface of the guide element 270 allows it to have a smooth head, which can be guided by the blood vessel wall within the blood vessel, reducing the risk of damage to the blood vessel wall. In a specific application scenario, when the core wire assembly 200 of the guidewire passes through a relatively narrow blood vessel area, the distal end of the guide element 270 with its smaller outer diameter can enter first, and the curved outer surface guides the rest of the guide element 270 through the area. Specifically, the operator can adjust the orientation of the core wire assembly 200 based on the tactile sensation when the guide element 270 contacts the narrow area, and ultimately pass through the narrow area.

[0065] This application also provides a guidewire system, including a guidewire and a host as described in any of the above embodiments. As shown in the figure, the detector 300 is connected to the distal end of the guidewire via an optical fiber 400 and is also connected to the host. The host can provide energy to the detector 300 and receive signals from the detector 300, process the signals from the detector 300, and display them.

[0066] In the description of this application, it should be understood that the orientation or positional relationship indicated by directional terms such as "front", "back", "up", "down", "left", "right", "horizontal", "vertical", "horizontal", "top", and "bottom" is generally based on the orientation or positional relationship shown in the accompanying drawings and is only for the convenience of describing this application and simplifying the description. Unless otherwise stated, these directional terms 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, and therefore should not be construed as a limitation on the scope of protection of this utility model; the directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.

[0067] For ease of description, relative terms such as "above," "over," "on the upper surface of," and "above" are used here to describe the regional positional relationship of one or more components or features shown in the figures to other components or features. It should be understood that relative terms include not only the orientation of the component as depicted in the figure but also different orientations during use or operation. For example, if the components in the figures are inverted as a whole, "above" or "above other components or features" will include cases where the component is "below" or "under" other components or features. Thus, the exemplary term "above" can include both "above" and "below." Furthermore, these components or features may also be positioned at other different angles (e.g., rotated 90 degrees or other angles), and this document intends to include all such cases.

[0068] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, parts, components, and / or combinations thereof.

[0069] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish similar subjects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in sequences other than those illustrated or described herein.

[0070] This application has been described through the above embodiments. However, it should be understood that the above embodiments are for illustrative purposes only and are not intended to limit this application to the scope of the described embodiments. Furthermore, those skilled in the art will understand that this application is not limited to the above embodiments, and many more variations and modifications can be made based on the teachings of this application, all of which fall within the scope of protection claimed by this utility model. The scope of protection of this utility model is defined by the appended claims and their equivalents.

Claims

1. A core wire assembly for a guide wire, characterized in that, include: One or more first coil elements with a central axis as the axis, wherein at least one of the one or more first coil elements includes multiple strands of first spring coils coaxially arranged with the central axis as the axis, the spring wires of the multiple strands of first spring coils are arranged side by side along the circumferential direction around the central axis and extend spirally around the central axis, and the multiple strands of first spring coils have the same pitch and spiral radius; as well as A shaping element, wherein one or more first coil elements are sleeved on the outside of the shaping element.

2. The core wire assembly as described in claim 1, characterized in that, The core wire assembly also includes one or more outer layer elements sleeved outside the one or more first coil elements.

3. The core wire assembly as described in claim 2, characterized in that, The one or more outer layer elements include one or more of the following: a second coil element, a hysteresis tube, and a braided tube.

4. The core wire assembly as claimed in claim 1, characterized in that, The core wire assembly also includes one or more intermediate layer elements disposed between the first coil element and the shaping element.

5. The core wire assembly as described in claim 4, characterized in that, The one or more intermediate layer elements include one or more of the following: a second coil element, a hysteresis tube, and a braided tube.

6. The core wire assembly as described in claim 3 or 5, characterized in that, The second coil element includes: Single-strand spring coil; and / or A multi-strand second spring coil, wherein the spring wires of the multi-strand second spring coil are arranged side by side along the circumferential direction around the central axis and extend spirally around the central axis, and the multi-strand second spring coils have the same pitch and spiral radius.

7. The core wire assembly as claimed in claim 1, characterized in that, The shaping element includes a shaping segment and a connecting segment, both extending along the central axis. The connecting segment is connected to the proximal end of the shaping segment and is used to connect to a push tube, which is sleeved on the shaping segment.

8. The core wire assembly as claimed in claim 7, characterized in that, The shaping segment includes a first sub-segment and a second sub-segment, both extending along the central axis, with the second sub-segment connecting the first sub-segment and the connecting segment. The second segment has a decreasing cross-sectional area along the direction towards the distal end. The first sub-segment is flat. Along the thickness direction of the first sub-segment, the first sub-segment has a first dimension, and the distal end of the second sub-segment has a second dimension, wherein the first dimension is smaller than the second dimension.

9. The core wire assembly as claimed in claim 1, characterized in that, The distal ends of the spring wires of the multi-strand first spring coil are flush; and / or The near ends of the spring wires of the multi-strand first spring coil are flush.

10. The core wire assembly as claimed in claim 1, characterized in that, Each strand of the multi-strand first spring coil does not contact each other.

11. The core wire assembly as claimed in claim 1, characterized in that, The core wire assembly also includes: A guide element is disposed at the distal end of the one or more first coil elements, the outer surface of the guide element being curved and having a decreasing outer diameter along the direction toward the distal end.

12. A guidewire, characterized in that, include: A slender, hollow push tube; A detector, wherein the detector is disposed inside the distal end of the push tube; as well as The core wire assembly as described in any one of claims 1-11, wherein the core wire assembly is connected to the distal end of the push tube.

13. The guidewire as described in claim 12, characterized in that, The push tube includes a sodium hypochlorite tube.

14. A guidewire system, characterized in that, include The guidewire as described in any one of claims 12-13; and The detector is connected to the host computer via optical fiber.

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