A push tube, a guide wire, and a guide wire system

Abstract

This application provides a push tube, a guide wire, and a guide wire system. The push tube has a hollow and elongated structure, comprising multiple segments distributed along its length. Each segment includes a push segment and a detection segment. The detection segment is connected to the distal end of the push segment, and its inner diameter is larger than that of the push segment. The detection segment is used to accommodate a detector, and a detection window is provided on its sidewall. The push segment has a distal portion extending a predetermined length from its distal end to its proximal end, and the distal portion has a tapering outer diameter in the direction toward the distal end. Compared to changing the inner diameter of the push tube, changing the outer diameter has a greater impact on the stiffness of the push tube, requiring less machining to achieve the desired performance, and is more convenient to manufacture.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to a delivery tube, guidewire, and 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 stability. Increasing guidewire flexibility allows for easier bending, facilitating passage through tortuous blood vessel segments. Guidewires consist of a delivery tube and a core wire assembly. Current guidewire delivery tubes are manufactured using laser cutting to create grooves on their surface, with the groove density controlled to ensure greater rigidity at the proximal end than the distal end. This results in significant time consumption during guidewire fabrication. Summary of the Invention

[0005] To at least partially address the problems existing in the prior art, one aspect of this application provides a push tube for a guidewire, the push tube having a hollow and elongated structure, the push tube comprising a plurality of segments distributed along its length direction, the plurality of segments including a push segment and a detection segment, the detection segment being connected to the distal end of the push segment, wherein: the inner diameter of the detection segment is larger than the inner diameter of the push segment, the detection segment is used to accommodate a detector, a detection window is provided on the sidewall of the detection segment; and the push segment has a distal portion extending a predetermined length from its distal end to its proximal end, the distal portion having a tapered outer diameter along the direction toward the distal end.

[0006] For example, a plurality of first slots are provided on the far end portion of the push segment, wherein: the plurality of first slots are arranged along the length direction of the push segment, the plurality of first slots are offset from each other along the circumferential direction of the push tube; and at least a portion of the plurality of first slots extends along the circumferential direction.

[0007] For example, in the distal portion, the smaller the outer diameter, the greater the axial spacing between adjacent first grooves along the length direction of the push segment.

[0008] For example, in the distal portion, the smaller the outer diameter, the smaller the axial spacing between adjacent first grooves along the length direction of the push segment.

[0009] For example, multiple first slots are arranged in pairs, with each pair of first slots arranged symmetrically about the central axis of the push segment.

[0010] For example, on the distal portion, the first groove has a larger depth and / or a smaller circumferential spacing corresponding to the smaller outer diameter portion, and the first groove has a smaller depth and / or a larger circumferential spacing corresponding to the larger outer diameter portion.

[0011] For example, the pair of first grooves are formed by axial-to-centric cutting.

[0012] For example, the pair of first grooves are formed by parallel symmetrical cutting.

[0013] For example, the outer diameter of the finest part of the distal portion is not less than 0.15 mm.

[0014] For example, the predetermined length is between 250mm and 350mm.

[0015] For example, the multiple segments also include a transition segment connected between the detection segment and the push segment, the proximal end of the transition segment having the same outer diameter as the distal end of the push segment, the distal end of the transition segment having the same outer diameter as the proximal end of the detection segment, and the outer diameter of the transition segment gradually increasing in a direction from its proximal end to its distal end.

[0016] For example, a plurality of second grooves are provided on the transition section, wherein: the plurality of second grooves are arranged along the length direction of the transition section, the plurality of second grooves are offset from each other along the circumferential direction of the transition section; and at least a portion of the plurality of second grooves extends along the circumferential direction.

[0017] For example, at least a portion of the outer wall of the distal portion of the push segment gradually tapers in the direction toward the distal end; or the outer wall of the distal portion of the push segment has a stepped surface toward the distal end, so that the distal portion has a reduced outer diameter in the direction toward the distal end.

[0018] This application also provides a guidewire, including the aforementioned push tube; a detector disposed within a detection section of the push tube; and a core wire assembly connected to the distal end of the detection section of the push tube.

[0019] For example, the core wire assembly includes: a shaping element; a core layer element, the core layer element being sleeved on the outside of the shaping element, the core layer element including: one or more first coil elements with a central axis as the axis, the one or more first coil elements including at least one layer of multiple first spring coils coaxially arranged with the central axis as the axis, the spring wires of the multiple 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 first spring coils having the same pitch and spiral radius; or a hollow tubular element, the sidewall of the tubular element being provided with a plurality of slots, 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 the circumferential direction around the central axis; and at least a portion of the plurality of slots extends along the circumferential direction.

[0020] For example, the core filament assembly also includes one or more outer layer elements disposed outside the core layer elements.

[0021] For example, one or more outer layer elements include one or more of a second coil element, a hysteresis tube, and a braided tube.

[0022] For example, the core filament assembly also includes one or more intermediate layer elements disposed between the core layer element and the shaping element.

[0023] For example, one or more intermediate layer elements include one or more of a second coil element, a hysteresis tube, and a braided tube.

[0024] For example, the second coil element includes a single-strand spring coil.

[0025] For example, the second coil element includes: a multi-strand second spring coil, wherein the spring wires of the multi-strand second spring coil are arranged side by side along a circumferential direction around a central axis and extend spirally around the central axis, and the multi-strand second spring coils have the same pitch and spiral radius.

[0026] 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.

[0027] Therefore, by reducing the diameter of the push tube at the distal end, the flexibility of the push tube can be gradually increased from the proximal end to the distal end. Compared to simply cutting grooves in the push tube, changing the diameter of the push tube can reduce the processing time, thereby reducing the cost of the push tube. Compared to changing the inner diameter of the push tube, changing the outer diameter has a greater impact on the stiffness of the push tube, requiring less processing to achieve the desired performance, and is also more convenient to process.

[0028] A series of simplified concepts are introduced in the description of the invention, which will be further explained in detail in the detailed description section. This 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.

[0029] The advantages and features of the present invention will be described in detail below with reference to the accompanying drawings. Attached Figure Description

[0030] 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.

[0031] Figure 1 A perspective view of a guidewire according to a first exemplary embodiment of this application is shown;

[0032] Figure 2 It shows Figure 1 A partial enlarged view of the guidewire in the illustrated embodiment;

[0033] Figure 3 A cross-sectional view of a guidewire according to a second embodiment of this application is shown;

[0034] Figure 4 A partial cross-sectional view of the push tube according to a third embodiment of this application is shown;

[0035] Figure 5 A partial cross-sectional view of the push tube according to the fourth embodiment of this application is shown;

[0036] Figure 6 A partial cross-sectional view of the push tube according to the fifth embodiment of this application is shown;

[0037] Figure 7 A partial front view of the push tube according to the sixth embodiment of this application is shown;

[0038] Figure 8 It shows that according to Figure 7 A partial cross-sectional view of the push tube in the illustrated embodiment;

[0039] Figure 9 A cross-sectional view of the push tube according to the seventh embodiment of this application is shown;

[0040] Figure 10 A cross-sectional view of the push tube according to the eighth embodiment of this application is shown;

[0041] Figure 11 A cross-sectional view of a core wire assembly according to a ninth embodiment of this application is shown;

[0042] Figure 12 A perspective view of the first coil element of the core wire assembly according to the tenth embodiment of this application is shown;

[0043] Figure 13 It shows that according to Figure 12 A cross-sectional view of the first coil element in the illustrated embodiment;

[0044] Figure 14 It shows that according to Figure 12 Front view of the first coil element in the illustrated embodiment;

[0045] Figure 15 It shows that according to Figure 12 A perspective view of a first spring coil in the first coil element of the illustrated embodiment;

[0046] Figure 16 A perspective view of a first coil element according to the eleventh embodiment of this application is shown;

[0047] Figure 17 A cross-sectional view of a tubular element according to the twelfth embodiment of this application is shown;

[0048] Figures 18-20 Cross-sectional views of the core wire assembly according to different exemplary embodiments of this application are shown respectively.

[0049] The above figures include the following reference numerals:

[0050] 100. Push tube; 110. Detection section; 111. Detection window; 120. Push section; 121. Distal section; 122. First slot; 1221. First sub-slot; 1222. Second sub-slot; 1223. Third sub-slot; 1224. Transverse beam; 1225. Axial beam; 130. Transition section; 131. Second slot; 140. Stepped surface; 200. Core wire assembly; 210. First coil element Components; 211, First spring coil; 212, Gap; 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; 251, Second spring coil; 270, Guide element; 300, Detector; 400, Optical fiber; 500, Tubular element; 510, Groove. Detailed Implementation

[0051] 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.

[0052] This application provides a guidewire, such as Figures 1-3As shown, the guidewire may include a slender, hollow push tube 100 and a detector 300, which may be disposed within the detection section 110 of the push tube 100. The detector 300 may include, for example, a fiber optic pressure detector for detecting intravascular pressure. 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 may also include a core wire assembly 200, which is connected to the distal end of the detection section 110 of the push tube 100. The core wire assembly 200 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. In this application, "proximal" and "distal" refer to the end of the guidewire closest to the operator and the end furthest from the operator, respectively. The guidewire typically has a diameter of around 0.3 mm and a length 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. The guidewire may include a core wire assembly 200, which is connected to the distal end of the push tube 100 to guide the detector 300 to the designated location and facilitate operator control. Optionally, the core wire assembly 200 may include one, two, or more of the following: a spring tube, a hypo tube, and a braided tube. Spring tubes offer better flexibility and support. Spring tubes may include a single-strand spring tube or a multi-strand spring tube wound with multiple springs. The core wire assembly 200 of the sodium hypochlorite tube exhibits good torsional rigidity. Taking the common cut-type sodium hypochlorite tube as an example, different textures are cut into the surface of the hollow steel tube, increasing its radial flexibility without affecting the transmission of axial force. Braided tubing also demonstrates good compressive strength, torsional rigidity, toughness, and tensile strength. In summary, each of these three components has its advantages and disadvantages; one, two, or a combination of all three can be used to achieve the desired physical properties. The core wire assembly 200 will be further described below.

[0053] This application also provides a push tube 100 for a guidewire. As shown in the figure, the push tube 100 includes multiple segments distributed along its length, including a push segment 120 and a detection segment 110. The detection segment 110 is connected to the distal end of the push segment 120, wherein the inner diameter of the detection segment 110 is larger than the inner diameter of the push segment 120. The detection segment 110 is used to accommodate a detector 300, and a detection window 111 is provided on the side wall of the detection segment 110. The push segment 120 has a distal portion 121 extending a predetermined length from its distal end to its proximal end, and the distal portion 121 has a tapering outer diameter along the direction toward the distal end. As mentioned above, for the push tube 100, its proximal end needs to have high stiffness to achieve good support and ensure good pushing performance and better maneuverability. At the same time, its distal end also needs to have low stiffness to ensure good flexibility and maneuverability. The stiffness change between the proximal and distal ends of the push tube 100 needs to be specially designed to ensure that the stiffness change is uniform and should not have significant abrupt changes that affect the operator's feel. The detection section 110 is connected to the distal end of the push section 120, and the inner diameter of the detection section 110 is larger than that of the push section 120, which to some extent reduces the rigidity of the distal end of the push tube 100. Since the outer diameter contributes significantly to bending and torsional inertia, changing the outer diameter can significantly alter the performance of the push tube 100, while changing the inner diameter has a relatively smaller impact. The following description focuses primarily on changing the outer diameter to reduce the rigidity of the push tube 100.

[0054] Therefore, by reducing the diameter of the push tube 100 at the distal end, the flexibility of the push tube 100 can be gradually increased from the proximal end to the distal end. Compared to simply cutting grooves in the push tube 100, changing the diameter of the push tube 100 can reduce the processing time, thereby reducing the cost of the push tube 100. Compared to changing the inner diameter of the push tube 100, changing the outer diameter of the push tube 100 has a greater impact on the stiffness of the push tube 100, requiring less processing to achieve the desired performance, and the processing is more convenient.

[0055] Exemplarily, at least a portion of the outer wall of the distal portion 121 of the push segment 120 gradually tapers towards the distal end. Optionally, the entire push end can be machined from the proximal end to the distal end. Optionally, 30%, 40%, 50%, etc., of the push segment 120 can also be machined, with the machined portion located at the distal end of the push segment 120. Optionally, the machined portion of the push segment 120 can extend to the end of the push segment 120, or it can terminate at a certain distance from the end of the push segment 120. Exemplarily, for the region of reduced outer diameter on the push tube 100, the outer diameter profile is specifically implemented as follows: (Refer to...) Figure 4 This region can be linearly gradual. In other words, from the proximal end to the distal end, the size decreases uniformly at equal intervals, and the change is uniform. This makes the outer surface of the push tube 100 a straight line in the cross-section along the radial direction. Figure 5 As shown, optionally, the region where the outer diameter decreases can also be a gradually tapering curve, and the outer surface of the push tube 100 can be curved in cross-section along the radial direction. (Reference) Figure 6 For example, the outer wall of the distal portion 121 of the pusher segment 120 has a stepped surface 140 facing the distal end, so that the distal portion 121 has a narrowing outer diameter along the direction towards the distal end. Thus, the outer surface of the pusher tube 100 is stepped. Specifically, for example, a step is formed at predetermined intervals from the proximal end to the distal end, and the diameters of the pusher tubes 100 on both sides of each step are different, with the diameter of the distal pusher tube 100 portion being smaller than that of the proximal pusher tube 100 portion. The pusher tube 100 portions between two adjacent steps have the same diameter. Optionally, the predetermined distance between adjacent steps from the proximal end to the distal end can be equal or unequal. Optionally, the above three gradation methods can also be combined; for example, the pusher tube 100 portions between two adjacent steps can be linearly or curvilinearly graded.

[0056] For example, a plurality of first slots 122 may be provided on the distal portion 121 of the push segment 120, wherein the plurality of first slots 122 are arranged along the length direction of the push segment 120 and offset from each other along the circumferential direction of the push tube 100. And at least a portion of the plurality of first slots 122 extends along the circumferential direction.

[0057] exist Figure 7 In the illustrated embodiment, all first grooves 122 extend in the circumferential direction. In other words, the proximal and distal faces of the first grooves 122 are perpendicular to the axis of the push tube 100. In an embodiment not shown, in addition to the first grooves 122 extending in the circumferential direction, there may also be first grooves 122 that extend not only in the circumferential direction but also offset in the length direction of the push segment 120. In other words, the extension direction of the first grooves 122 may have an angle with the face perpendicular to the axis of the push tube 100, and one end of the extension direction of the first groove 122 may be closer to the distal end than the other end of the extension direction of the first groove 122.

[0058] As mentioned above, the flexibility, maneuverability, and support stiffness of the push tube 100 are coupled to some extent. Stiffness, also known as rigidity, corresponds 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 the distal portion 121 of the same material, a larger polar moment of inertia results in greater torsional stiffness; in the X direction, a larger moment of inertia results in greater bending stiffness and better support; similarly, a larger moment of inertia in the Y direction results in greater bending stiffness and better 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.

[0059] In summary, the rigidity of the push tube 100 can be gradually reduced from the proximal end to the distal end in several ways. Besides the existing technique of gradually increasing groove density from the proximal end to the distal end, the diameter of the push tube 100 can be gradually reduced from the proximal end to the distal end to satisfy the gradually decreasing rigidity requirement. Furthermore, while the diameter of the push tube 100 gradually decreases from the proximal end to the distal end, a first groove 122 is provided on the push tube 100. When the diameter of the push tube 100 decreases, the density of the first grooves 122 can be uniform, meaning that each segment of the push tube 100 has the same number, depth, and spacing of first grooves 122; alternatively, the first grooves can be gradually sparser or denser, as long as the rigidity of the push tube 100 in the various embodiments is the same. In embodiments not shown, some push tubes achieve a change in rigidity from the proximal end to the distal end by changing the material or using different heat treatments, surface treatments, etc.

[0060] Reference Figure 7 and Figure 8 For example, an axial beam 1225 is formed between adjacent first grooves 122 on the axial direction PP of the distal portion 121, and a transverse beam 1224 is formed between the two ends of a single first groove 122 or between the two adjacent ends of two adjacent first grooves 122 on the same cross section. Specifically, the distal portion 121 includes a first sub-groove 1221, a second sub-groove 1222 arranged along the axial direction PP with the first grooves 122, and a third sub-groove 1223 arranged along the circumferential direction with the first grooves 122. The beam formed between the first sub-groove 1221 and the second sub-groove 1222 is the axial beam 1225, and the beam formed between the first sub-groove 1221 and the third sub-groove 1223 is the transverse beam 1224. 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 1224 and the axial beam 1225. In the guidewire design, the strain (deformation) of adjacent axial beams 1225 and transverse beams 1224 should be as equal as possible when the guidewire is subjected to torsional and bending forces. This prevents one or the other from becoming a weak point of deformation failure when torque is applied. Multiple first grooves 122 are offset from each other circumferentially around the central axis, such that in the axial direction PP, the axial beams 1225 are offset from each other circumferentially, ultimately making the bending stiffness of the distal portion 121 approximately similar in all directions and ensuring its torsional stiffness. Specifically, for example, the starting positions of two adjacent first grooves 122 in the axial direction PP form an angle with the line connecting them to the axis PP; optionally, the angle can be 85 degrees. Figure 8Taking the illustrated embodiment as an example, the end of the first sub-groove 1221 near the second sub-groove 1222, and the end of the second sub-groove 1222 away from the first sub-groove 1221, can be at an 85-degree angle in the circumferential direction. During processing, the push tube can always be rotated in the same direction, and the laser cuts from one end of the first sub-groove 1221 to the other end. When cutting the second sub-groove 1222 adjacent along the length direction, the starting point of the laser cutting forms one end of the second sub-groove 1222, and this end forms an arc with an arc angle of 85 degrees with the end of the first sub-groove 1221 where the cutting begins.

[0061] When machining the first groove 122, optionally, the first groove 122 can penetrate the wall of the distal portion 121. Alternatively, the first groove 122 may not penetrate the wall of the distal portion 121, resulting in a recess on the surface of the distal portion 121. In this case, the depth of the first groove 122 can be controlled. For the first groove 122 extending in the circumferential direction, the axial width PP of the first groove 122 and the distance between PP and adjacent first grooves 122 in the axial direction affect the dimensions of the axial beam 1225. The circumferential extension dimension of the first groove 122 and the number of first grooves 122 corresponding to the same cross-section can affect the dimensions of the transverse beam 1224. By proper configuration, the parameters of the aforementioned push tube 100 can be adjusted.

[0062] Continue to refer to Figure 8 For example, on the distal portion 121, the smaller the outer diameter, the greater the axial spacing between adjacent first grooves 122 along the length direction of the pushing segment 120. The left side of the pushing tube shown in the figure corresponds to the distal end of the pushing tube, and the right side corresponds to the proximal end. As mentioned above, the greater the groove density, the lower the rigidity of the pushing tube 100. Since the distal portion 121 already meets the rigidity requirement by reducing its outer diameter, the density of the first grooves 122 can be reduced, thereby reducing the number of grooves required for each pushing tube 100 and thus lowering the manufacturing cost of the pushing tube 100. Reducing the density of the first grooves also prevents breakage at the distal end of excessively thin pushing tubes.

[0063] Of course, the above embodiments are only exemplary embodiments of this application. This application does not exclude embodiments in which the axial spacing of adjacent first grooves 122 in the length direction is uniformly arranged or gradually decreases as the outer diameter decreases on the distal portion 121.

[0064] For example, the smaller the outer diameter, the smaller the axial spacing between adjacent first grooves along the length of the push segment. This allows for greater flexibility at the distal end of the push segment.

[0065] For example, the setting of the axial spacing between adjacent first grooves can be determined as follows: The setting of the axial spacing between adjacent first grooves in the length direction is determined by considering whether the reduction in outer diameter meets the requirements for the overall flexibility of the push tube and the relationship between the stiffness difference ratio between the distal and proximal ends and a set threshold. Further, if the reduction in outer diameter is insufficient to meet the requirements for the overall flexibility of the push tube, the overall flexibility of the push tube needs to be further improved by grooving. Even further, if the reduction in outer diameter is insufficient to meet the requirements for the overall flexibility of the push tube, and the stiffness difference ratio between the distal and proximal ends is equal to the set threshold, then the overall flexibility of the push tube is too low, while the stiffness difference between the distal and proximal ends meets the requirements. Based on this, the axial spacing between adjacent first grooves in the length direction is uniform to further improve the overall flexibility of the push tube through grooving. On the other hand, if the reduction in outer diameter is insufficient to meet the requirements for the overall flexibility of the push tube, and the stiffness difference ratio between the distal and proximal ends is greater than the set threshold, then the overall flexibility of the push tube is too low, and the stiffness difference between the distal and proximal ends is too large. Based on this, the smaller the outer diameter, the more uniform the axial spacing between the first grooves in the length direction. At locations with smaller outer diameters, the axial spacing between adjacent first grooves along the length direction is larger, so as to further improve the overall flexibility of the push tube through the grooves and ensure the rigidity of the far end of the push tube through the larger spacing of the grooves. On the other hand, if the reduction in outer diameter is insufficient to meet the requirements for the overall flexibility of the push tube, and the rigidity difference ratio between the far end and the near end is less than the set threshold, then the overall flexibility of the push tube is too low, and the rigidity difference between the far end and the near end is too low. Based on this, at locations with smaller outer diameters, the axial spacing between adjacent first grooves along the length direction is smaller, so as to further improve the overall flexibility of the push tube through the grooves and ensure the flexibility of the far end of the push tube through the smaller spacing of the grooves.

[0066] For example, factors affecting the stiffness of the push tube, such as the depth of the first groove and the circumferential spacing, can also be set in combination with whether the reduction of the outer diameter meets the requirements for the overall flexibility of the push tube and the relationship between the stiffness difference ratio between the far end and the near end and the set threshold. Specifically, they can be set in the manner described above, and this application embodiment will not elaborate further.

[0067] For example, multiple first grooves 122 are arranged in pairs, with each pair of first grooves 122 symmetrically arranged about the central axis of the pushing section 120. Taking the arrangement of a pair of first grooves 122 on one cross-section of the pushing tube 100 as an example, the paired first grooves 122 ensure that the pushing tube 100 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 on the cross-section where the first groove 122 is located. Arranging first grooves 122 symmetrically on both sides of the pushing tube 100 can not only significantly reduce the bending stiffness of the cross-section where the first groove 122 is located, but also avoid the first groove 122 being too long or the spacing between adjacent first grooves 122 corresponding to the same cross-section being too close when only one first groove 122 is provided, thus increasing the processing difficulty and affecting the reliability of the tubular element 500, while achieving the same bending stiffness.

[0068] For example, on the distal portion 121, corresponding to the portion with a smaller outer diameter, the first groove 122 can have a larger depth. Thus, the smaller outer diameter of the distal portion 121 and the deeper first groove 122 can work together to reduce the rigidity of the push tube. Optionally, at the location with a smaller outer diameter, the first groove 122 can have a smaller circumferential spacing. Optionally, the circumferential spacing at different locations can be the same in proportion to the outer diameter at that location. In some exemplary embodiments, at the location with a smaller outer diameter, the circumferential spacing of the first groove can be smaller in size than the circumferential spacing of the first groove at the location with a larger outer diameter. However, the ratio of the circumferential spacing at the location with a smaller outer diameter to the outer diameter at that location can be greater than the ratio of the circumferential spacing of the first groove to the outer diameter at the location with a larger outer diameter. Specifically, for example, at an outer diameter of 0.18 mm, the circumferential spacing of the first groove can be 0.093 mm, while at an outer diameter of 0.19 mm, the circumferential spacing of the first groove can be 0.096 mm, with the ratio changing from 0.516 to 0.505. Conversely, for the portion with a larger outer diameter, the first groove has a smaller depth, or a larger circumferential spacing, or both a smaller depth and a larger circumferential spacing.

[0069] For example, parallel symmetrical cutting such as Figure 9 As shown, axial centripetal cutting is as follows Figure 10 As shown.

[0070] The outer diameter contributes significantly to bending and torsional inertia (polar moment of inertia). For the same torsional capacity, a centripetal cut has a smaller cross-sectional area and weaker tensile strength. For parts of the push tube 100 prone to tensile failure, parallel cutting can be used instead of centripetal cutting, provided the torsional inertia (polar moment of inertia) is comparable. Similarly, for parts of the push tube 100 prone to torsional failure, centripetal cutting can be used instead of parallel cutting, provided the area (and tensile strength) is comparable.

[0071] In some exemplary embodiments, all the first grooves of the push tube 100 are set to be parallel cuts or centripetal cuts while ensuring mechanical properties, thereby reducing the types of cuts and lowering the processing difficulty and cost. In some embodiments, the guidewire needs to pass through a critical lesion area where the blood vessel is narrow. The distal end of the push tube needs to reduce the risk of tensile and push strength failure while ensuring bending and torsional performance. The part with a large outer diameter can be cut parallelly, and the part with a small outer diameter can be cut centripetally.

[0072] For example, the outer diameter of the finest part of the distal portion 121 is not less than 0.15 mm. This avoids the push tube 100 having a diameter that is too small to match the core wire assembly 200, or a wall thickness that is too thin, resulting in difficulty in processing and insufficient strength. For example, the predetermined length is between 250 mm and 350 mm. The guidewire extends gradually from larger blood vessels to smaller ones, and the rigidity of the proximal end of the push tube 100 needs to be changed almost without any change. Processing only the push tube 100 of the predetermined length can reduce the processing cost of the guidewire.

[0073] exist Figure 3 In the illustrated embodiment, the multiple segments may further include a relatively long transition segment 130, which connects the detection segment 110 and the push segment 120. The proximal end of the transition segment 130 has the same outer diameter as the distal end of the push segment, and the distal end of the transition segment 130 has the same outer diameter as the proximal end of the detection segment 110. The outer diameter of the transition segment 130 gradually increases in a direction from its proximal end to its distal end. Figures 4-6 In the illustrated embodiment, the transition section 130 is relatively short. The detection section 110 and the push section 120 of the guidewire can be directly connected together. Since the detection section at the distal end of the push tube needs to accommodate the detector, its diameter is larger than that of the smallest diameter part of the push tube. By providing the transition section 130, the detection section 110 and the push section 120 can be smoothly connected.

[0074] For example, the transition section 130 is provided with a plurality of second grooves 131, wherein the plurality of second grooves 131 are arranged along the length direction of the transition section 130, and the plurality of second grooves 131 are offset from each other along the circumferential direction of the transition section 130; and at least a portion of the plurality of second grooves 131 extends along the circumferential direction. Similar to the first groove 122 described above, the second grooves 131 can make the transition section 130 have better flexibility and a smaller reduction in rotational stiffness.

[0075] For example, the length of the transition section can be relatively small. In this case, the transition section may not need to have a slot, such as... Figures 4-7 As shown.

[0076] like Figure 11As shown, exemplarily, the core wire assembly 200 may include a shaping element 220 and a core layer element. The core layer element is sleeved on the outside of the shaping element 220 and includes one or more first coil elements 210 about a central axis. Each first coil element 210 includes at least one layer of multiple first spring coils 211 coaxially arranged about the central axis. The spring wires of the multiple 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 first spring coils 211 have the same pitch and spiral radius. Specifically, the core wire assembly 200 may include only one layer of first coil elements 210, which is a multiple first spring coil 211. The core wire assembly 200 may include multiple layers of first coil elements 210. Optionally, the multiple layers of first coil elements 210 may include one layer of multi-strand first spring coils 211 and multiple layers of single-strand spring coils; alternatively, each layer of the multiple layers of first coil elements 210 may be a multi-strand first spring coil 211. The spring wires of the multi-strand 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 multi-strand first spring coils 211 have the same pitch and spiral radius. (Refer to reference...) Figures 12-15 , Figure 12 A perspective view of an exemplary multi-strand first spring coil 211 is shown. Figure 13 The cross-section of the multi-strand first spring coil 211 is shown. Figure 14 The side view of the multi-strand first spring coil 211 is shown. Figure 15 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 12-14 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 16 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.

[0077] Optionally, each of the multi-strand first spring coils 211 can be kept in close contact through 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 multi-strand first spring coils 211 have superior elastic deformation capabilities in both the axial and radial directions compared to single-strand spring coils 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 multiple first spring coils 211 does not contact each other, the stiffness of the multi-strand spring tube can be adjusted by adjusting the radius of the spiral steel wire to R2, the spiral angle of the steel wire α, and the number of spring strands m.

[0078] Return to reference Figure 13 With the material and the total axial length of the spring remaining unchanged,

[0079] The bending stiffness of a single-layer multi-strand spring satisfies:

[0080]

[0081] Torsional stiffness satisfies:

[0082]

[0083] Where K1 and K2 are stiffness constants, and v is the Poisson's ratio of the spring wire.

[0084] From the above formulas, we know that the greater the wire radius R2, the greater the bending and torsional stiffness of the spring; the greater the helix angle θ, the greater the axial clearance of the 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.

[0085] 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.

[0086] 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 coupled to each other through a small gap 212, preventing gaps 212 on the surface of the core wire assembly 200 from being larger than those in existing core wire assemblies. 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. 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, thus providing operators with a wider variety of guidewires to suit various surgical needs.

[0087] For example, the core layer element may include a hollow tubular element 500, on which a plurality of slots 510 are provided. The slots 510 are arranged along an axial direction parallel to the central axis of the tubular element 500, offset from each other in a circumferential direction around the central axis, and at least a portion of the slots 510 extend in the circumferential direction. Thus, by providing the tubular element 500, the torsional stiffness of the core wire assembly 200 can be significantly improved due to the inherent physical properties of the tubular element 500. Providing slots 510 on the surface of the tubular element 500 can primarily change the bending stiffness of each segment of the tubular element 500, resulting in better flexibility of the core wire 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 an existing core wire assembly 200, and there will be no excessively large gaps on the surface. In summary, the core wire assembly 200 of this application can significantly increase the torsional rigidity of the core wire assembly 200 without changing the surface properties of the existing core wire assembly 200, thereby providing operators with a wider variety of guide wires to suit various surgical needs.

[0088] Optionally, the tubular element 500 can be as follows: Figure 17 As shown, a relatively dense array of grooves 510 can be provided at the distal end of the tubular element 500, thereby reducing the distal end rigidity. In this case, the distal diameter of the tubular element 500 can be configured to be equal to the proximal diameter. Alternatively, the distal diameter can also be configured to be smaller than the proximal diameter. As mentioned above, reducing the rigidity of the tubular element 500 solely by machining the grooves 510 can reduce the number of processes, but the machining time will increase significantly. By reducing the distal diameter in conjunction with the grooves 510, the density of the grooves 510 can be reduced, shortening the machining time required. The method for reducing the distal diameter of the tubular element 500 is consistent with the method for pushing the tube described above, and will not be repeated here.

[0089] Exemplarily, the core wire assembly 200 also includes one or more outer layer elements 230 disposed outside one or more core layer elements. Without changing the wire diameter, the flexibility of the core layer element can be altered by changing its outer diameter. Based on this, one or more outer layer elements 230 can be disposed outside the core layer element 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 sodium hydrofoil tube, and a braided tube. (Refer to reference...) Figure 18 and Figure 19 The outer element 230 may include a second coil element 250. For example... Figure 18 As shown, the core wire assembly 200A may include a second coil element 250 located between the first spring coil 211 and the outer layer assembly 230. Figure 18 The illustrated core wire assembly 200A may include a single-layer first spring coil 211. The second coil element 250 may include multiple strands of second spring coils 251, 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 251 have the same pitch and helical radius. The advantages of the multiple strands of second spring coils 251 are the same as those of the multiple strands of first spring coils 211, and will not be repeated here. Optionally, the first coil element 210 may also include more than one layer of single-strand spring coil, or more than one layer of multiple strands of first spring coil 211. Optionally, the second coil element 250 may also include more than one layer of single-strand spring coil, or more than one layer of multiple strands of second spring coil 251. Figure 19As shown, the second coil element 250 of the core wire assembly 200B may include a multi-layered first spring coil 211 and a single-layered second spring coil 251. Optionally, the second spring coil may be 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 combine multi-stranded second spring coils 251 with single-stranded spring coils. It should be noted that the cross-sections of multi-stranded second spring coils 251 and single-stranded spring coils are almost indistinguishable; therefore, this application... Figures 18-20 Each layer of the first spring coil 211 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 211 is included in one or more layers. Similarly, for the second spring coil 251, this application... Figures 18-20 Each layer of the second spring coil 251 shown can be considered as a multi-strand second spring coil 251, or as a single-strand spring coil. Figure 20 In the illustrated embodiment, the outer element 230 may further include a hysteresis tube.

[0090] In the embodiments of the aforementioned core wire assembly 200A / 200B / 200C that include the outer layer element 230, the core layer element is equivalent to serving as the intermediate 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 core layer element, and an outermost outer layer element 230. Exemplarily, the core wire assembly 200 may also include at least one middle layer element 240 disposed between the core layer element 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 core layer element. Exemplarily, the at least one middle layer element 240 includes one or more of a second coil element 250, a sodium hydrofoil tube, and a braided tube. The aforementioned outer layer element 230 and middle layer element 240 can use the same element, making the performance of the core wire assembly 200 significantly superior to other aspects in one respect. The outer element 230 and the middle element 240 can also be different elements. In some performance parameters, the outer element has a greater impact than the inner element. By properly configuring the middle element 240 and the outer element 230, the guidewire can achieve the desired performance.

[0091] It should be noted that the above embodiments only show some embodiments of the core wire assembly 200. In these embodiments, the layer in close contact with the shaping element 220 can be a core layer element, with an outer layer element disposed outside the core layer element; the layer in close contact with the shaping element 220 can also be a middle layer element, with an outer layer element disposed outside the core layer element. Therefore, in some embodiments, the layer in close contact with the core wire assembly 220... Figure 20The core wire assembly 200C shown has the same structure as the core wire assembly, and the outermost layer can also be a tubular element 500, which is the core layer element.

[0092] 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.

[0093] In the description of this application, it should be understood that the orientation or positional relationship indicated by directional terms such as "front", "rear", "up", "down", "left", "right", "lateral", "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 invention; the directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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 invention. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A pusher tube for a guide wire, characterized in that The push tube has a hollow and elongated structure, comprising multiple segments distributed along its length, each segment including a push segment and a detection segment, the detection segment being connected to the distal end of the push segment, wherein: The inner diameter of the detection section is larger than the inner diameter of the pushing section. The detection section is used to accommodate the detector, and a detection window is provided on the side wall of the detection section; and The push segment has a distal portion extending a predetermined length from its distal end to its proximal end, the distal portion having a tapering outer diameter along the direction toward the distal end.

2. The push tube of claim 1, wherein, The distal portion of the push segment is provided with a plurality of first slots, wherein: The plurality of first grooves are arranged along the length of the pushing segment, and the plurality of first grooves are offset from each other along the circumferential direction of the pushing tube; and At least a portion of the plurality of first grooves extends along the circumferential direction.

3. The push tube of claim 2, wherein, On the distal portion, the smaller the outer diameter, the greater the axial spacing between adjacent first grooves along the length direction of the push segment; or, The smaller the outer diameter, the smaller the axial spacing between adjacent first grooves along the length direction of the push segment.

4. The push tube as described in claim 3, characterized in that, The plurality of first slots are arranged in pairs, and each pair of first slots is symmetrical about the central axis of the push segment.

5. The push tube as described in claim 4, characterized in that, On the distal portion, the first groove has a greater depth and / or a smaller circumferential spacing corresponding to the smaller outer diameter, and the first groove has a smaller depth and / or a larger circumferential spacing corresponding to the larger outer diameter.

6. The push tube as described in claim 4, characterized in that, The paired first grooves are formed by axial-to-centric cutting; and / or The first cut in pairs is formed by parallel symmetrical cutting.

7. The push tube as described in claim 1, characterized in that, The outer diameter of the thinnest part of the distal portion is not less than 0.15 mm.

8. The push tube as described in claim 1, characterized in that, The predetermined length is between 250mm and 350mm.

9. The push tube as described in claim 1, characterized in that, The plurality of segments further includes a transition segment connecting the detection segment and the push segment, wherein the proximal end of the transition segment has the same outer diameter as the distal end of the push segment, and the distal end of the transition segment has the same outer diameter as the proximal end of the detection segment. The outer diameter of the transition section gradually increases in the direction from its proximal end to its distal end.

10. The push tube as described in claim 9, characterized in that, The transition section is provided with multiple second grooves, wherein: The plurality of second grooves are arranged along the length of the transition section, and the plurality of second grooves are offset from each other along the circumferential direction of the transition section; and At least a portion of the plurality of second grooves extends along the circumferential direction.

11. The push tube as described in any one of claims 1-10, characterized in that, At least a portion of the outer wall of the distal portion of the push segment gradually tapers in the direction toward the distal end; or The outer wall of the distal portion of the push segment has a stepped surface facing the distal end, so that the distal portion has a reduced outer diameter along the direction facing the distal end.

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

13. The guidewire as described in claim 12, characterized in that, The core wire assembly includes: Shaping elements; A core layer element, wherein the core layer element is sleeved on the outside of the shaping element, the core layer element comprising: One or more first coil elements with a central axis as the axis, the one or more first coil elements including at least one layer of multi-strand first spring coils coaxially arranged with the central axis as the axis, the spring wires of the multi-strand first spring coils being arranged side by side along the circumferential direction around the central axis and extending spirally around the central axis, the multi-strand first spring coils having the same pitch and spiral radius; or 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.

14. The guidewire as described in claim 13, characterized in that, The core wire assembly also includes one or more outer layer elements surrounding the core layer element.

15. The guidewire as described in claim 14, 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.

16. The guidewire as described in claim 13, characterized in that, The core wire assembly also includes one or more intermediate layer elements disposed between the core layer element and the shaping element.

17. The guidewire as described in claim 16, 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.

18. The guidewire as described in claim 15 or 17, 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.

19. A guidewire system, characterized in that, include The guidewire as described in any one of claims 12-18; and The detector is connected to the host computer via optical fiber.

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