A core wire assembly for a guide wire, a guide wire and a guide wire system
By incorporating grooves and multi-layered structures in the core wire assembly of the guidewire, the torsional rigidity and flexibility of the guidewire are optimized, solving the problem of difficult guidewire manipulation within blood vessels and achieving better vascular accessibility and support.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-03
- Publication Date
- 2026-06-09
Smart Images
Figure CN224331348U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical devices, and more specifically, to a core wire assembly for a guidewire, a guidewire, and a guidewire system. 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: a hollow tubular element having a plurality of grooves provided on the sidewall of the tubular element, wherein: the plurality of grooves are arranged along an axial direction parallel to the central axis of the tubular element, the plurality of grooves are offset from each other along a circumferential direction around the central axis; and at least a portion of the plurality of grooves extends along the circumferential direction; and a shaping element having the tubular element sleeved on the outside of the shaping element.
[0006] For example, the core wire assembly also includes at least one outer layer element disposed outside the tubular element.
[0007] For example, at least one outer layer element includes one or more of coil elements, hysteresis tubes, and braided tubes.
[0008] For example, the core wire assembly also includes at least one intermediate layer element disposed between the tubular element and the shaping element.
[0009] For example, at least one middle layer element includes one or more of coil elements, hysteresis tubes, and braided tubes.
[0010] For example, the coil element includes a single-strand spring coil.
[0011] For example, the coil element includes a multi-strand spring coil, wherein the spring wires of the multi-strand spring coil are arranged side by side in the circumferential direction and extend spirally around a central axis, and the multi-strand spring coil has the same pitch and spiral radius.
[0012] For example, there are multiple tubular elements, which are nested together.
[0013] For example, the distal outer diameter of the tubular element is smaller than the proximal outer diameter of the tubular element.
[0014] For example, at least a portion of the outer wall of the tubular element contracts in a direction toward the distal end, such that the distal outer diameter is smaller than the proximal outer diameter.
[0015] For example, the outer wall of the tubular element has a stepped surface toward the distal end of the tubular element, such that the distal outer diameter is smaller than the proximal outer diameter.
[0016] For example, there is a first gap between adjacent slots on the distal end of the tubular element and a second gap between adjacent slots on the proximal end of the tubular element, the first gap being smaller than the second gap.
[0017] For example, multiple slots are arranged in pairs, with each pair of slots symmetrically arranged about the central axis on the sidewall of the tubular element.
[0018] For example, the shaping element includes a shaping segment and a connecting segment, both extending along the axial direction, the connecting segment being connected to the proximal end of the shaping segment and used to connect to the push tube, the tubular element being sleeved on the shaping segment.
[0019] For example, the shaping segment includes a first sub-segment and a second sub-segment that both extend along an axial direction. 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. The first dimension is smaller than the second dimension.
[0020] Exemplarily, the core wire assembly further includes a guide element disposed at the distal end of the tubular element, the guide element having a curved outer surface and a decreasing outer diameter along the direction toward the distal end.
[0021] This application also provides a guidewire, including 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.
[0022] For example, the push tube includes a hysteresis tube.
[0023] 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.
[0024] Therefore, by incorporating a tubular element, the torsional stiffness of the mandrel assembly can be significantly improved due to the inherent physical properties of the tubular element. Grooves on the surface of the tubular element can primarily alter the bending stiffness of each segment, resulting in better flexibility of the mandrel assembly using the tubular element. The outer surface of the tubular element can be treated in the same way as the outer surface of existing mandrel assemblies, without excessive gaps. In summary, the mandrel assembly of this application can significantly increase the torsional stiffness of the mandrel assembly without altering the surface properties of existing mandrel assemblies, thus providing operators with a wider variety of guidewires to suit diverse surgical needs.
[0025] 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.
[0026] The advantages and features of this utility model will be described in detail below with reference to the accompanying drawings. Attached Figure Description
[0027] 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.
[0028] Figure 1 A perspective view of a guidewire according to a first exemplary embodiment of this application is shown;
[0029] Figure 2 It shows Figure 1 A partial enlarged view of the guidewire in the illustrated embodiment;
[0030] Figure 3 It shows that according to Figure 1 A cross-sectional view of the guidewire in the illustrated embodiment;
[0031] Figure 4 It shows that according to Figure 3 A partially enlarged cross-sectional view of the guidewire in the illustrated embodiment;
[0032] Figure 5 A perspective view of a tubular element according to a second exemplary embodiment of this application is shown;
[0033] Figure 6 It shows Figure 5 A partial enlarged view of the tubular element in the exemplary embodiment shown;
[0034] Figure 7 A cross-sectional view of a tubular element according to a third exemplary embodiment of this application is shown;
[0035] Figure 8 A cross-sectional view of a tubular element according to a fourth exemplary embodiment of this application is shown;
[0036] Figure 9 A cross-sectional view of a tubular element according to a fifth exemplary embodiment of this application is shown;
[0037] Figure 10 A cross-sectional view of a tubular element according to a sixth exemplary embodiment of this application is shown;
[0038] Figures 11-15 Cross-sectional views of the core wire assembly according to different exemplary embodiments of this application are shown respectively;
[0039] Figure 16A A perspective view of the second coil element of the core wire assembly according to the seventh exemplary embodiment of this application is shown;
[0040] Figure 16B It shows that according to Figure 16A A cross-sectional view of the second coil element in the illustrated embodiment;
[0041] Figure 16C It shows that according to Figure 16A Front view of the second coil element in the illustrated embodiment;
[0042] Figure 17 It shows that according to Figure 16A A perspective view of one spring coil in the second coil element of the illustrated embodiment;
[0043] Figure 18 A perspective view of a second coil element according to another exemplary embodiment of this application is shown.
[0044] The above figures include the following reference numerals:
[0045] 10. Distal end; 20. Proximal end; 100. Push tube; 110. Detector opening; 200. Core wire assembly; 220. Shaping element; 221. Shaping segment; 2211. First sub-segment; 2212. Second sub-segment; 222. Connecting segment; 230. Outer layer element; 240. Middle layer element; 250. Second coil element; 251. Spring coil; 252. Slit; 270. Guide element; 300. Detector; 400. Optical fiber; 500. Tubular element; 510. Groove; 511. First groove; 512. Second groove; 513. Third groove; 520. Transverse beam; 530. Axial beam. Detailed Implementation
[0046] 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.
[0047] This application provides a guidewire, in conjunction with a reference. Figures 1-4The guidewire may include a slender and hollow push tube 100. In this application, the proximal end 20 and distal end 10 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 actual proportions of the 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. 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 100, including the hypotube, has good torsional rigidity. Taking the common cut hypotube as an example, the cut hypotube improves its radial flexibility without affecting the transmission of axial force by cutting different textures on the surface of the hollow steel tube. In summary, each of the above three components has its advantages and disadvantages, and one, two, or three of them can be used to achieve the desired physical performance. The guidewire may also include a detector 300, which is disposed inside the distal end 10 of the push tube 100. The detector 300 may include, for example, a fiber optic pressure detector 300 or a detector 300 used to detect intravascular pressure. The push tube 100 may be provided with a detector opening 110 to expose 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 can extend to the proximal end 20 through the inner lumen of the hollow push tube 100. The guidewire also includes a core wire assembly 200 according to any of the above embodiments. The core wire assembly 200 is connected to the distal end 10 of the push tube 100 to guide the detector 300 to a designated position and facilitates operator control. The core wire assembly 200 can act as a guide within the blood vessel. The flexibility of both the core wire assembly 200 and the push tube 100 gradually increases from the proximal end 20 to the distal end 10, thereby providing strong support for the guidewire as a whole at the proximal end 20 while allowing for easy bending at the distal end 10, thus navigating various tortuous vascular environments.
[0048] For example, the push tube 100 may include a sodium hypochlorite tube. As mentioned above, the sodium hypochlorite tube can have good torque transmission performance while also having relatively strong support. Combined with the core wire assembly 200 with high torsional stiffness, the guide wire as a whole has high torsional stiffness. Such a guide wire can be applied to some special application scenarios.
[0049] This application also provides a core wire assembly 200 for the aforementioned guide wire. For example... Figure 5 and Figure 6As shown, the core wire assembly 200 includes a hollow tubular element 500, and a plurality of slots 510 are provided on the sidewall of the tubular element 500. The plurality of slots 510 are arranged along an axial direction PP parallel to the central axis of the tubular element 500, and the plurality of slots 510 are offset from each other in a circumferential direction around the central axis. Furthermore, at least a portion of the plurality of slots 510 extends in the circumferential direction. Figure 5 In the illustrated embodiment, all grooves 510 extend in the circumferential direction. In other words, the face of the groove 510 near the proximal end 20 and the face of the groove 510 near the distal end 10 are both perpendicular to the central axis. In an embodiment not shown, in addition to the grooves 510 extending in the circumferential direction, grooves 510 that extend not only in the circumferential direction but are also offset in the axial direction PP may be included. In other words, the extension direction of the groove 510 may have an angle with the face perpendicular to the axis, and one end of the extension direction of the groove 510 may be closer to the distal end 10 than the other end of the extension direction of the groove 510.
[0050] As mentioned above, the flexibility, maneuverability, and support stiffness of the core wire assembly 200 are coupled to some extent. These three indicators correspond to the following physical quantities: bending stiffness, torsional stiffness, polar moment of inertia, moment of inertia in the X direction, and moment of inertia in the Y direction. For tubular elements 500 of the same material, the larger the polar moment of inertia, the greater the torsional stiffness; in the X direction, the larger the moment of inertia, the greater the bending stiffness and the better the support; similarly, in the Y direction, the larger the moment of inertia, the greater the bending stiffness and the better the support stiffness. The moment of inertia is defined as the sum of the squares of the distances from all points on the cross section to the coordinate axes, reflecting the distribution of points on the cross section relative to the axes.
[0051] Reference Figure 5 and Figure 7For example, an axial beam 530 is formed between adjacent slots 510 on the axial direction PP of the tubular element 500, and a transverse beam 520 is formed between the two ends of a single slot 510 or between the two adjacent ends of two adjacent slots 510 on the same cross section. Specifically, the tubular element 500 includes a first slot 511, a second slot 512 arranged along the axial direction PP with respect to the first slot 511, and a third slot 513 arranged along the circumferential direction with respect to the first slot 511. The beam formed between the first slot 511 and the second slot 512 is the axial beam 530, and the beam formed between the first slot 511 and the second slot 512 is the transverse beam 520. The torsional stiffness of the guidewire relative to its flexibility or the stiffness of the crossbeam can be selectively changed by adjusting the size, shape, spacing, and orientation of the transverse beam 520 and the axial beam 530. In the guidewire design, the strain (deformation) of adjacent axial beams 530 and transverse beams 520 should be as equal as possible when the guidewire is subjected to torsional and bending forces. In this way, when torque is applied, one or the other will not become a weak point of deformation failure. The multiple slots 510 are offset from each other in the circumferential direction around the central axis, so that in the axial direction PP, the axial beams 530 are offset from each other in the circumferential direction, which ultimately makes the bending stiffness of the tubular element 500 as a whole similar in all directions and ensures its torsional stiffness.
[0052] When machining the groove 510, optionally, the groove 510 may penetrate through the wall of the tubular element 500. Alternatively, the groove 510 may not penetrate the wall of the tubular element 500, resulting in a recess on the surface of the tubular element 500. In this case, the depth of the groove 510 can be controlled. The shape of the cut can be as follows: Figure 8 The parallel symmetrical cut shown and Figure 9 The diagram shows a axially oriented radial cut. Because the outer diameter contributes significantly to bending and torsional inertia, a radially oriented cut results in a smaller cross-sectional area and weaker tensile strength for the same torsional capacity. If the application scenario is prone to tensile failure, a parallel-cut tubular element 500 can be used for the core wire assembly 200, provided that the torsional inertia (polar moment of inertia) is comparable. If the application scenario is prone to torsional failure, a radially oriented tubular element 500 can be used for the core wire assembly 200, provided that the area (tensile strength) is comparable. For the circumferentially extending groove 510, the axial width PP of the groove 510 and the spacing between PP and adjacent grooves 510 in the axial direction affect the dimensions of the axial beam 530. The circumferential extension dimension of the groove 510 and the number of grooves 510 corresponding to the same cross-section can affect the dimensions of the transverse beam 520. These guide wire parameters can be adjusted through proper configuration.
[0053] The core wire assembly 200 may further include a shaping element 220, with a tubular element 500 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 10 of which can be bent and held in a bent state under external force. During guidewire insertion, the distal end 10 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 20 of the guidewire, torque is transmitted along the guidewire to the distal end 10, causing the bent portion of the distal end 10 to align with the direction of the blood vessel to be entered. Optionally, the shaping element 220 may be flattened at its distal end 10, requiring different forces to bend in different radial directions, thus facilitating bending in one direction.
[0054] Therefore, by incorporating the tubular element 500, the torsional rigidity of the mandrel assembly 200 can be significantly improved due to the inherent physical properties of the tubular element 500. The groove 510 on the surface of the tubular element 500 primarily alters the bending rigidity of each segment of the tubular element 500, resulting in better flexibility of the mandrel assembly 200 using the tubular element 500. The outer surface of the tubular element 500 can be treated in the same way as the outer surface of existing mandrel assemblies 200, and there will be no excessively large gaps 252 on the surface. In summary, the mandrel assembly 200 of this application can significantly increase the torsional rigidity of the mandrel assembly 200 without altering the surface properties of existing mandrel assemblies 200, thus providing operators with a wider variety of guidewires to suit various surgical needs.
[0055] For example, the outer diameter of the distal end 10 of the tubular element 500 can be smaller than the outer diameter of the proximal end 20. This allows the distal end 10 of the tubular element 500 to have greater flexibility than the proximal end 20 when the groove 510 is uniform. Specifically, the distal end 10 of the tubular element 500 can be machined by grinding. For example, at least a portion of the outer wall of the tubular element 500 tapers in the direction toward the distal end 10, so that the outer diameter of the distal end 10 is smaller than the outer diameter of the proximal end 20. Changing its outer diameter is easier to process than changing the diameter of the inner hole of the tubular element 500. Figure 10 As shown, optionally, the entire tubular element 500 can be smoothly inclined from the proximal end 20 to the distal end 10, and the entire tubular element 500 can be uniformly machined from the proximal end 20 to the distal end 10. Optionally, 30%, 40%, 50%, etc., of the entire tubular element 500 can also be machined, with the machined portion located at the distal end 10 of the tubular element 500. For the contracted portion of the tubular element 500, the corresponding cross-section of its surface can be a straight line or a curve.
[0056] For example, the outer wall of the tubular element 500 has a stepped surface toward the distal end 10 of the tubular element 500, such that the outer diameter of the distal end 10 is smaller than the outer diameter of the proximal end 20. Compared to continuous processing, the tubular element 500 can also be made to taper into a pagoda shape, making processing simpler. However, correspondingly, when the pagoda-shaped tubular element 500 is applied to the outer layer of the core wire assembly 200, it may lead to increased damage to blood vessels by the core wire assembly 200. Optionally, when using multilayer tubular elements 500, the pagoda-shaped tubular element 500 is disposed in the inner layer.
[0057] For example, a first gap is provided between adjacent slots 510 on the distal end 10 of the tubular element 500, and a second gap is provided between adjacent slots 510 on the proximal end of the tubular element 500, the first gap being smaller than the second gap. Thus, the distal end 10 of the tubular element 500 can have more slots 510 than its proximal end 20, resulting in a lower bending stiffness and better flexibility for the distal end 10 of the tubular element 500 than for its proximal end 20.
[0058] In the embodiment where the diameter of the tubular element 500 shrinks from the proximal end 20 to the distal end 10, when the shrinkage is small, the first gap between adjacent grooves 510 on the distal end 10 of the tubular element 500 can also be smaller than the second gap between adjacent grooves 510 on the proximal end 20, so that the dense grooves 510 and the shrinkage diameter together make the distal end 10 of the tubular element 500 more flexible. Optionally, when the first gap is smaller than the second gap, refer back to the reference. Figure 7 The diameter of the distal end 10 of the tubular element 500 does not need to be reduced; the flexibility of the distal end 10 is ensured solely by the densely spaced grooves 510. Optionally, the first gap can be equal to the second gap, and the tubular element 500 achieves the required flexibility simply by reducing the diameter of the distal end 10. In short, the flexibility is changed only by the relatively densely spaced grooves 510, without the need for an additional processing step. Furthermore, when the diameters of the proximal end 20 and the distal end 10 of the tubular element 500 are different, the processing time generated by machining the densely spaced grooves 510 can be reduced.
[0059] For example, multiple slots 510 are arranged in pairs, with each pair of slots 510 symmetrically arranged about the central axis on the side wall of the tubular element 500. Taking a pair of slots 510 on one cross-section of the tubular element 500 as an example, the paired slots 510 ensure that the tubular element 500 has the same first flexibility in one lateral direction and the same second flexibility in a second lateral direction perpendicular to the first lateral direction at the cross-section where the slots 510 are located. Arranging slots 510 symmetrically on both sides of the tubular element 500 can not only significantly reduce the bending stiffness of the cross-section where the slots 510 are located, but also avoid the situation where, when only one slot 510 is provided, the slot 510 is too long, or the spacing between adjacent slots 510 on the same cross-section is too close, which would increase the processing difficulty and affect the reliability of the tubular element 500, even when achieving the same bending stiffness.
[0060] For example, at least a portion of the plurality of grooves 510 penetrates the sidewall of the tubular element 500. Alternatively, all the grooves 510 may penetrate the sidewall of the tubular element 500, for example, by processing along the diameter direction of the tubular element 500 using a laser. Processing through grooves 510 is less difficult. For example, at least a portion of the plurality of grooves 510 forms a recess that is recessed inward from the outer side of the tubular element 500. The laser may cut along the tangential direction of the tubular element 500, so that only grooves are formed on the surface of the tubular element 500, but the hollow interior of the tubular element 500 is not connected to the outside through the grooves 510. Different processing methods have different advantages and disadvantages, and the physical properties of the formed tubular element 500 also differ.
[0061] like Figure 11 and Figure 12 As shown, exemplarily, the core wire assembly 200 also includes at least one outer layer element 230 sleeved outside the tubular element 500. Without changing the wire diameter, the flexibility of the tubular element 500 can be altered by changing its outer diameter. Based on this, one or more outer layer elements 230 can be sleeved around the tubular element 500 to change the physical properties of the core wire assembly 200 in terms of flexibility, torsional stiffness, support, and maneuverability. Figure 11 The shown core wire assembly 200A may include two layers of second coil elements 250, while Figure 11The illustrated core wire assembly 200A may include only one layer of second coil element 250. Exemplarily, at least one outer layer element 230 may include one or more of the second coil element 250, a hyaluronic acid tube, and a braided tube. The second coil element 250 may include a single-strand spring coil 251. The single-strand spring coil 251 has a simple structure and low cost, but its torsional rigidity is relatively poor. Optionally, the second coil element 250 may include a multi-strand spring coil 251, the spring wires of which are arranged side-by-side along the circumferential direction around a central axis and extend spirally around the central axis, the multi-strand spring coils 251 having the same pitch and helical radius. Optionally, the coil element may also include more than one layer of single-strand spring coil 251, or more than one layer of multi-strand spring coil 251. Optionally, the second coil element 250 may also combine multi-strand spring coils 251 with single-strand spring coils 251.
[0062] In embodiments using a hyaluronic acid tube as the outer layer element 230, the torsional stiffness of the core wire assembly 200 can be further improved, while the loss of flexibility is minimal. In embodiments using a braided tube 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 comprise a combination of the aforementioned outer layer elements 230.
[0063] 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.
[0064] In the embodiment where the core wire assembly 200 includes an outer layer element 230, the tubular element 500 is used as the inner layer of the core wire assembly 200, and the outer surface of the core wire assembly 200 is formed by the outer layer element 230. Thus, the core wire assembly 200 includes an innermost shaping element 220, an intermediate tubular element 500, and an outermost outer layer element 230. Figure 13 and Figure 14 As shown, exemplarily, the core wire assembly 200 may further include at least one middle layer element 240 disposed between the tubular element 500 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 element 240, and the outermost tubular element 500.
[0065] For example, at least one middle layer element 240 includes one or more of a second coil element 250, a hysteresis tube, and a braided tube. Figure 13 In the embodiment shown, each of the two middle layer elements 240 of the core wire assembly 200C can be a second coil element 250. Figure 14In the illustrated embodiment, the middle layer element 240 of the core wire assembly 200D may include a second coil element 250. The middle layer element 240 may be a sodium hypochlorite tube. The outer layer element 230 and the middle layer element 240 may use the same element, making the performance of the core wire assembly 200 significantly better than other aspects in one aspect. The outer layer element 230 and the middle layer element 240 may also use different elements. In some performance parameters, the elements located on the outer layer have a greater impact than the elements located on the inner layer. By properly configuring the middle layer element 240 and the outer layer element 230, the guide wire can achieve the desired performance.
[0066] like Figure 15 As shown, exemplarily, the core wire assembly 200E can have multiple tubular elements 500, which are nested together. A larger outer diameter results in a larger moment of inertia and greater bending stiffness. For the same inner and outer diameter, a hollow steel tube has a larger cross-sectional area and a higher upper limit of bending stiffness than a single-strand spring. Smaller diameter tubular elements 500 have a relatively smaller impact on the flexibility of the core wire assembly 200; simply put, for tubes with the same wall thickness, a smaller diameter results in better flexibility. Therefore, the outer tubular elements 500 have a greater impact on the flexibility of the core wire assembly 200. The inner tubular elements 500 can have fewer grooves 510, and these grooves 510 are staggered from those of the outer tubular elements 500. This makes the tubular elements 500 less prone to breakage. For the inner tubular elements 500, fewer grooves 510 reduce processing time and lower costs. Optionally, the inner tubular element 500 and the outer tubular element 500 can be machined together with grooves 510, so that the grooves 510 of the two correspond to each other in number and position.
[0067] Reference Figures 16A-17 The multi-strand spring coil 251 mentioned above is shown in the figure. Figure 16A A perspective view of an exemplary multi-strand spring coil 251 is shown. Figure 16B The cross-section of the multi-strand spring coil 251 is shown. Figure 16C The side of the multi-strand spring coil 251 is shown. Figure 17 The diagram shows one of the multiple spring coils 251. It should be understood that the pitch of one spring coil 251 may not be less than the sum of the wire diameters of the multiple spring coils 251. When the multiple spring coils 251 are wound coaxially, adjacent spring coils 251 form only a small gap 252 between them. Figures 16A-16C The multi-strand spring coil 251 shown is formed from 5 strands of spring wire; in embodiments not shown, it may also be formed from more or fewer strands of spring wire. Figure 18As shown, the second coil element 250 can be stacked. In the stacked second coil assembly, the two layers of multi-strand spring coils 251 can have opposite helical directions, thereby having similar torsional stiffness in both the forward and reverse directions.
[0068] Optionally, each spring coil 251 of the multi-strand spring coil 251 can be kept in close contact with a certain preload, thus forming an integral structure. Optionally, each spring coil 251 can be non-contacting, thus forming a certain gap 252. The multi-strand spring coil 251 can evenly distribute stress when subjected to external loads, improving its load-bearing capacity and stability. The elastic deformation capacity of the multi-strand spring coil 251 in both the axial and radial directions is superior to that of a single-strand spring coil 251 with the same wire diameter. The multi-strand spring coil 251 can undergo elastic deformation within a certain range and return to its original shape after the external force disappears. Even if one of the multi-strand spring coils 251 breaks, the other spring coils 251 can hold it in place, preventing the entire spring coil 251 from failing. This facilitates timely detection and safe removal by the operator for replacement with a new guide wire. When each spring coil 251 of the multi-strand spring coil 251 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.
[0069] Return to reference Figure 16B With the material and the total axial length of the spring remaining unchanged,
[0070] The bending stiffness of a single-layer multi-strand spring satisfies:
[0071]
[0072] Torsional stiffness satisfies:
[0073]
[0074] in It is the stiffness constant. Let be the Poisson's ratio of the spring wire.
[0075] 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.
[0076] The multi-strand spring coil 251 can distribute the torsional force acting on a single spring steel wire to multiple strands of spring coil 251, significantly improving its torsional rigidity while keeping the wire diameter unchanged. Each strand of the multi-strand spring coil 251 is connected to each other through a small gap 252. When the multi-strand spring coil 251 of the second coil element 250 serves as an outer layer component, gaps 252 larger than those in the existing core wire assembly 200 are not generated on the surface of the core wire assembly 200. Furthermore, the outer diameter of each spring coil 251 is the same, allowing the overall outer diameter of the core wire assembly 200 to be consistent with that of the existing core wire assembly 200.
[0077] Exemplarily, 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 20 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 constructed with a thinner distal end 10 and a thicker proximal end 20, allowing the thicker proximal end 20 to mate with the larger inner diameter of the push tube 100. This enables the core wire assembly 200 to be reliably connected to the push tube 100, and the shaping element 220 can be bent with the assistance of an instrument or by hand. A tubular element 500 is fitted onto the shaping section 221. When the shaping element 221 is bent, the tubular element 500 is also bent, causing the distal end 10 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 push tube 100, making the connection more reliable and less prone to separation. Optionally, the connecting section 222 can be connected to the push tube 100 by processes such as adhesives, interference fits, or welding.
[0078] 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 10. As described above, for the guidewire, the flexibility gradually increases from the proximal end 20 to the distal end 10, resulting in better support performance at the proximal end 20, facilitating guidewire delivery, and better flexibility at the distal end 10, enabling passage through tortuous blood vessels. The second sub-segment 2212 with a gradually decreasing cross-sectional area can be shaped by spinning, grinding, or other methods to achieve the performance of gradually increasing flexibility from the proximal end 20 to the distal end 10. 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 10 of the second sub-segment 2212 has a second dimension, with the first dimension being smaller than the second dimension. Optionally, the first segment 2211 can be manufactured from the second segment 2212 by processes such as stamping, which reduces manufacturing costs. Before processing, the first segment 2211 can have a decreasing diameter towards the distal end, resulting in a cross-sectional area no larger than that of the second segment after flattening. This maintains that the flexibility at the distal end 10 is no greater than that at the proximal end 20, preventing abnormal tactile sensations for the operator. Figure 11 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 4 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.
[0079] Exemplarily, the core wire assembly 200 may further include a guide element 270 disposed at the distal end 10 of the tubular element 500. The guide element 270 has a curved outer surface and a decreasing outer diameter along the direction toward the distal end 10. The outer diameter of the guide element 270 may be slightly larger than the outer diameter of the tubular element 500, thereby avoiding the formation of a sharp step between the tubular element 500 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 10 of the shaping element 220, and when the shaping element 220 is bent, the guide element 270 forms an angle with the other parts of the guidewire, 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 10 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.
[0080] 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 10 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.
[0081] 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.
[0082] 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.
[0083] 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.
[0084] 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.
[0085] 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: A hollow tubular element has a plurality of slots on its sidewalls, wherein: the plurality of slots are arranged along an axial direction parallel to the central axis of the tubular element, the plurality of slots are offset from each other along a circumferential direction around the central axis; and at least a portion of the plurality of slots extends along the circumferential direction. as well as A shaping element, wherein the tubular element is 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 at least one outer layer element that is sleeved outside the tubular element.
3. The core wire assembly as described in claim 2, characterized in that, The at least one outer layer element includes one or more of coil elements, hysteresis tubes, and braided tubes.
4. The core wire assembly as claimed in claim 1, characterized in that, The core wire assembly further includes at least one intermediate layer element disposed between the tubular element and the shaping element.
5. The core wire assembly as described in claim 4, characterized in that, The at least one middle layer element includes one or more of coil elements, hysteresis tubes, and braided tubes.
6. The core wire assembly as described in claim 3 or 5, characterized in that, The coil element includes: Single-strand spring coil; and / or A multi-strand spring coil, wherein the spring wires of the multi-strand spring coil are arranged side by side along the circumferential direction and extend spirally around the central axis, and the multi-strand spring coils have the same pitch and spiral radius.
7. The core wire assembly as claimed in claim 1, characterized in that, There are multiple tubular elements, which are nested together.
8. The core wire assembly as claimed in claim 1, characterized in that, The distal outer diameter of the tubular element is smaller than the proximal outer diameter of the tubular element.
9. The core wire assembly as claimed in claim 8, characterized in that, At least a portion of the outer wall of the tubular element tapers toward the distal end, such that the outer diameter of the distal end is smaller than the outer diameter of the proximal end; or The outer wall of the tubular element has a stepped surface toward the distal end of the tubular element, such that the outer diameter of the distal end is smaller than the outer diameter of the proximal end.
10. The core wire assembly as claimed in claim 8, characterized in that, There is a first gap between adjacent grooves on the distal end of the tubular element. A second gap exists between adjacent grooves on the proximal end of the tubular element. The first gap is smaller than the second gap.
11. The core wire assembly as claimed in claim 1, characterized in that, The plurality of slots are arranged in pairs, and each pair of slots is symmetrically arranged on the side wall of the tubular element about the central axis.
12. The core wire assembly as claimed in claim 1, characterized in that, The shaping element includes a shaping section and a connecting section that both extend along the axial direction. The connecting section is connected to the proximal end of the shaping section and is used to connect to the push tube. The tubular element is sleeved on the shaping section.
13. The core wire assembly as claimed in claim 12, characterized in that, The shaping segment includes a first sub-segment and a second sub-segment, both extending along the axial direction, 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.
14. 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 tubular element, the outer surface of the guide element being curved and having a decreasing outer diameter along the direction toward the distal end.
15. 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 1-14, wherein the core wire assembly is connected to the distal end of the push tube.
16. The guidewire as described in claim 15, characterized in that, The push tube includes a sodium hypochlorite tube.
17. A guidewire system, characterized in that, include The guidewire as described in any one of claims 15-16; and The detector is connected to the host computer via optical fiber.