Hypotube and guidewire

Abstract

The invention provides a hypotube and a guide wire. The hypotube is applied to a guide wire and comprises at least two tube sections which are sequentially distributed in the extension direction of the hypotube. The hypotube comprises a body part and a concave part formed in the body part. In the at least one pipe section, at least one concave part extends on the circumferential surface of the body part to form spiral distribution, and the pipe section comprises a plurality of threaded sections arranged in the extending direction of the concave part. And the body part between the adjacent threaded sections forms a ring part along the extension direction of the sea wave tube. The stiffness of the tube section near the proximal end of the hypotube is greater than the stiffness of the tube section near the distal end of the hypotube. At least one of the screw pitch of the ring part and the width of the concave part is different between different pipe sections; the width of the concave part is the distance between the two opposite side faces, perpendicular to the extending direction of the concave part, of the concave part. The pipe sections of the hypotube have different rigidities, and the hypotube has good traceability and accessibility.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular, to a hypotube and a guidewire. Background Art

[0002] Guidewires and other interventional medical devices usually need to have a certain degree of stiffness and flexibility to ensure good trackability and accessibility in tortuous anatomical structures, good torque transmission during delivery, and ensure that the distal end can be bent to a smaller radius to give the auxiliary blood vessel the proper curved shape.

[0003] With the development of micromachining technology, related technologies have adopted hypotubes with recessed sections as reinforcements within guidewires. However, existing hypotubes are limited by the cutting elements or the shape of the recessed sections, resulting in nearly uniform stiffness across the entire hypotube, making it difficult to achieve the required stiffness and flexibility at different locations. Summary of the Invention

[0004] In response to the shortcomings of the existing methods, this application proposes a sea wave tube and a guide wire to solve the technical problem in the related art that the overall stiffness of the existing sea wave tube is almost uniform, and it is difficult to simultaneously have the stiffness and flexibility required at different positions.

[0005] In a first aspect, an embodiment of the present application provides a hypotube for use with a guidewire, comprising at least two tube sections sequentially distributed along the extension direction of the hypotube. The hypotube comprises a main body and a recessed portion formed in the main body.

[0006] In at least one pipe section, at least one recess extends on the circumference of the main body to form a spiral distribution, including a plurality of thread segments arranged along the extension direction of the recess.

[0007] Along the extending direction of the waveguide, the body portion between adjacent thread segments forms a ring portion.

[0008] The stiffness of the tube section near the proximal end of the hypotube is greater than the stiffness of the tube section near the distal end of the hypotube.

[0009] At least one of the pitch of the ring portion and the width of the recess is different between different pipe sections; the width of the recess is the distance between two opposite side surfaces of the recess perpendicular to the extending direction of the recess.

[0010] In some possible embodiments, the number of the recess is one, spirally surrounding at least two tube segments.

[0011] In some possible embodiments, there are multiple recesses.

[0012] In at least one pipe section, at least two recesses extend at intervals on the circumference of the main body to form a spiral distribution.

[0013] Along the extending direction of the recessed portions, the body portions between adjacent recessed portions form beam portions.

[0014] At least one of the length of the beam and the combined length of adjacent recesses and the beam is different between different pipe sections. The length of the beam is the dimension of the beam along the extending direction of the adjacent recess, and the length of the recess is the dimension of the recess along the extending direction.

[0015] In some possible embodiments, the stiffness of the multiple tube sections of the hypotube gradually increases from the distal end of the hypotube to the proximal end of the hypotube.

[0016] In some possible embodiments, in at least one tube segment, at least one recess extends along the circumference of the main body to form an annular distribution, and the annularly distributed recesses are closer to the proximal end than the helically distributed recesses.

[0017] In some possible embodiments, a central angle corresponding to a combination structure of adjacent recesses and beam portions is not less than 90 degrees and not greater than 115 degrees.

[0018] The pitch of the ring portion is not less than 0.02 mm and not more than 0.25 mm.

[0019] The width of the recess is not less than 0.011 mm and not more than 0.018 mm.

[0020] The central angle corresponding to the beam portion is not less than 8 degrees and not more than 16 degrees.

[0021] In some possible embodiments, the outer diameter of the main body is no greater than 0.125 mm.

[0022] The central angle corresponding to the combined structure of adjacent recesses and beams is not less than 70 degrees and not more than 110 degrees.

[0023] The pitch of the ring portion is not less than 0.05 mm and not more than 1 mm.

[0024] The width of the recess is not less than 0.001 mm and not more than 0.006 mm.

[0025] The central angle corresponding to the beam portion is not less than 3 degrees and not more than 50 degrees.

[0026] In some possible embodiments, the width of the recessed portion of the tube segment near the distal end of the hypotube is greater than the width of the recessed portion of the tube segment near the proximal end of the hypotube.

[0027] In some possible embodiments, the length of the recessed portion of the tube segment near the distal end of the hypotube is greater than the length of the recessed portion of the tube segment near the proximal end of the hypotube.

[0028] In some possible embodiments, the pitch of the ring portion of the tube segment near the distal end of the hypotube is smaller than the pitch of the ring portion of the tube segment near the proximal end of the hypotube.

[0029] In some possible embodiments, the length of the beam portion in the tube section near the distal end of the hypotube is smaller than the length of the beam portion in the tube section near the proximal end of the hypotube.

[0030] In some possible embodiments, the hypotube includes a first tube section near the distal end.

[0031] In the first tube section, along the extension direction from the distal end to the proximal end, the pitch of the ring portion increases sequentially in a first design manner, and the length of the beam portion remains unchanged.

[0032] In some possible embodiments, the hypotube further includes a second tube segment that is farther away from the distal end than the first tube segment.

[0033] In the second tube section, along the extension direction from the distal end to the proximal end, the pitch of the ring portion increases in a second design manner, and the length of the beam portion increases in a third design manner.

[0034] In some possible embodiments, the hypotube further includes a third tube segment closer to the proximal end than the second tube segment.

[0035] In the third tube section, along the direction from the distal end to the proximal end, the pitch of the ring portion and the length of the beam portion remain unchanged.

[0036] In some possible embodiments, the first design mode, the second design mode, and the third design mode each include at least one of a linear mode, an exponential mode, or a logarithmic mode.

[0037] In some possible embodiments, the main body includes a plurality of sub-parts divided along the circumferential direction.

[0038] At least one of the pitch of the ring portion, the length of the beam portion, the width of the recess, and the combined length of adjacent recesses and beam portions is different between at least two sub-portions.

[0039] In some possible embodiments, the width of the recess gradually decreases along the radial direction of the waveguide toward the center of the circle.

[0040] In some possible embodiments, an angle is formed between two opposite side surfaces of the recess in the extension direction of the hypotube.

[0041] In a second aspect, an embodiment of the present application further provides a guidewire, comprising: a core wire, a coil, and any hypotube provided in the first aspect above.

[0042] The coil is wrapped around the outer circumference of the distal end portion of the core wire.

[0043] The hypotube is tubular and is arranged around a portion of the coil and a portion of the core wire.

[0044] The beneficial technical effects brought about by the technical solutions provided in the embodiments of the present application include: The hypotube in the embodiments of the present application comprises at least two tube segments, with the segment near the proximal end of the hypotube having greater stiffness than the segment near the distal end. This ensures that the different tube segments have their desired stiffness and flexibility, providing excellent trackability and accessibility. Furthermore, the diverse shapes or patterns of the recesses facilitate the formation of a hypotube with both good stiffness and flexibility. This allows for balancing the complex bending stiffness, tensile strength, and torsional strength requirements of the human vascular system while achieving a smaller bending radius when the guidewire shape is modified as needed.

[0045] Additional aspects and advantages of the present application will be given in part in the following description, which will become apparent from the following description, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the following description of the embodiments in conjunction with the accompanying drawings, in which: Figure 1 A schematic diagram of the structure of a hypotube provided in an embodiment of the present application; Figure 2 A schematic structural diagram of another hypotube provided in an embodiment of the present application; Figure 3 A schematic structural diagram of another hypotube provided in an embodiment of the present application; Figure 4 A schematic structural diagram of another hypotube provided in an embodiment of the present application; Figure 5 A schematic structural diagram of a first tube section of a hypotube provided in an embodiment of the present application; Figure 6 A schematic structural diagram of a second tube section of a hypotube provided in an embodiment of the present application; Figure 7 A schematic structural diagram of a third tube section of a hypotube provided in an embodiment of the present application; Figure 8 A schematic cross-sectional view of a hypotube provided in an embodiment of the present application; Figure 9 A schematic cross-sectional view of a hypotube in a bent state provided in an embodiment of the present application.

[0047] Reference numerals: 110 - main body; 111 - ring; 112 - beam; 113 - inner side of main body 110; 114 - outer side of main body 110; 120 - recess; 100- pipe section; 101- first pipe section; 102- second pipe section; 103- third pipe section; A-distal end; B-proximal end. DETAILED DESCRIPTION

[0048] The following describes the embodiments of the present application in conjunction with the accompanying drawings. It should be understood that the embodiments described below in conjunction with the accompanying drawings are exemplary descriptions for explaining the technical solutions of the embodiments of the present application and do not constitute a limitation on the technical solutions of the embodiments of the present application.

[0049] Those skilled in the art will understand that, unless otherwise stated, the terms "said" and "the" used herein may also include plural forms. It should be further understood that the term "including" used in the specification of this application refers to the presence of the features, integers, operations, elements and / or components, but does not exclude the implementation of other features, information, data, operations, elements, components and / or their combinations supported by the technical field. The term "and / or" used herein refers to at least one of the items defined by the term, for example, "A and / or B" can be implemented as "A", or as "B", or as "A and B".

[0050] In order to make the objectives, technical solutions and advantages of this application clearer, the implementation methods of this application will be further described in detail below with reference to the accompanying drawings.

[0051] The research and development ideas of this application include: In the related art, a hypotube is grooved on the main body to form a recessed portion, which makes the hypotube have a certain degree of rigidity and flexibility. Currently, most hypotubes are cut on the main body using micromachining technologies such as micro sawing or wire cutting to form the recessed portion.

[0052] This micromachining technology is subject to many limitations in terms of the geometry of the recess, the cuttable length, and the processing speed. The hardness of the resulting sea wave tube is basically the same at all positions, making it difficult to adjust the hardness and, consequently, difficult to form a sea wave tube with both the required stiffness and flexibility.

[0053] The sea wave tube and guide wire provided in this application are intended to solve the above technical problems of related technologies.

[0054] The following is a detailed description of the technical solution of the present application and how the technical solution of the present application solves the above-mentioned technical problems with specific embodiments. It should be noted that the following embodiments can refer to, draw on, or combine with each other, and the same terms, similar features, and similar implementation steps in different embodiments will not be repeated.

[0055] The present application provides a hypotube, which is applied to a guide wire, such as Figure 1 As shown, the hypotube comprises at least two tube sections 100 sequentially distributed along the extension direction of the hypotube; Figure 2-Figure 7 As shown, the hypotube includes a main body 110 and a recess 120 formed in the main body 110 .

[0056] In at least one pipe segment 100 , at least one recess 120 extends on the circumference of the main body 110 to form a spiral distribution, including a plurality of thread segments arranged along the extension direction of the recess 120 .

[0057] Along the extension direction of the waveguide (such as Figure 5 (from left to right in the figure), the body portion 110 between adjacent thread segments forms a ring portion 111.

[0058] The stiffness of the tube section 100 near the proximal end B of the hypotube is greater than the stiffness of the tube section 100 near the distal end A of the hypotube.

[0059] refer to Figure 2 and Figure 4 At least one of the pitch X of the ring portion 111 and the width D of the recess 120 is different between different pipe sections 100; the width D of the recess 120 is the distance between two opposite side surfaces of the recess 120 in a direction perpendicular to the extension direction of the recess 120.

[0060] The hypotube in the embodiment of the present application includes at least two tube segments 100. The pitch X of the ring portion 111 or the width D of the recess 120 varies depending on the position from the distal end A, so that each tube segment 100 has the desired stiffness and flexibility. It should be noted that the pitch X of the ring portion 111 can be regarded as the width X of the main body 110 between the threaded segments of adjacent recesses 120. The stiffness of the tube segment 100 near the proximal end B of the hypotube is greater than the stiffness of the tube segment 100 near the distal end A of the hypotube, so that different tube segments 100 have their own desired stiffness and flexibility, and have good trackability and accessibility.

[0061] Furthermore, the use of micromachining techniques such as microsaws or wire cutting in related art to form the recess 120 results in the existing hypotube segments 100 having uniform stiffness or difficulty in adjusting. While the proximal end B has sufficient stiffness to push the coil, the distal end A, close to the coil, has excessive stiffness, resulting in an excessively large minimum bending radius, making it difficult to pass through a lumen with a smaller bending radius. The hypotube in the embodiment of the present application can use laser cutting technology to form the recess 120 on the main body 110, allowing for a richer shape or pattern of the recess 120. The cutting parameters are controllable, facilitating the formation of a hypotube with both good stiffness and flexibility. This allows for balancing the complex bending stiffness, tensile strength, and torsional strength requirements of the human vascular system while achieving a smaller bending radius when the shape of the guidewire is changed as needed.

[0062] The extending direction perpendicular to the recess 120 may also be the normal direction of the recess 120 .

[0063] It should be noted that the thread segments refer to the multiple parts obtained by dividing the recess 120 in the extension direction of the recess 120, and a thread segment only circles the body 110 at most, that is, on a plane perpendicular to the extension direction of the body 110, the orthographic projections of a thread segment have no overlapping area. Figure 5 In the direction from left to right in the figure), the main body 110 between adjacent thread segments may refer to the main body 110 between adjacent thread segments of the same recess 120, or may refer to the main body 110 between adjacent thread segments of adjacent recesses 120.

[0064] It should be noted that Figures 1-4 The three-dot ellipsis in the figure indicates that at least one pipe segment is omitted. Due to limited space, it is difficult to draw all of them. Those skilled in the art will understand that the number of pipe segments can be determined according to actual conditions.

[0065] It is understood that the main body 110 is a tubular structure, and the recess 120 is formed on the circumference of the main body 110. The recess 120 can be a through groove extending from the outer circumference to the inner circumference of the main body 110, or a groove that does not extend to the inner circumference. The recess 120 is distributed in a spiral shape along the circumference of the main body 110. The recess 120 can be a continuous structure extending between the multiple tube segments 100.

[0066] It can be understood that the cutting parameters may refer to parameters of the sea wave tube pattern, such as the pitch X of the ring portion 111, the length Y of the beam portion 112, the width D of the recess 120, and the combined length of any recess 120 and an adjacent beam portion 112.

[0067] In some possible embodiments, the number of the recess 120 is one, spirally surrounding at least two pipe segments 100 .

[0068] In this embodiment, a recess 120 extends on at least two tube sections 100 of the hypotube in a spiral shape.

[0069] In some possible embodiments, reference Figure 2 In at least one pipe section 100 , at least two recesses 120 extend at intervals on the circumference of the main body 110 to form a spiral distribution.

[0070] Along the extending direction of the recesses 120 , the body portions between adjacent recesses 120 form beam portions 112 .

[0071] At least one of the length Y of the beam portion 112 and the combined length of the adjacent recess 120 and the beam portion 112 is different between different pipe sections 100; the length Y of the beam portion 112 is the dimension of the beam portion 112 along the extension direction of the adjacent recess 120, and the length of the recess 120 is the dimension of the recess 120 along the extension direction of the recess 120.

[0072] In this embodiment, the number of recesses 120 can be multiple, extending at intervals around the circumference of the main body 110, with the multiple recesses 120 being distributed in a spiral shape. The embodiment of the present application utilizes laser cutting technology to achieve the pattern of the recesses 120, enabling the hypotube to achieve a balance of bendability, rigidity, or flexibility that is currently unattainable using other micromachining technologies.

[0073] Different from the previous embodiment, the present application also provides an embodiment in which the number of recesses 120 is multiple, regardless of the case where there is only one recess. Figure 2 In at least one pipe segment 100, at least two recesses 120 extend at intervals on the circumference of the main body 110 to form a spiral distribution. Along the extension direction of the recesses 120, the main body between adjacent recesses 120 forms a beam portion 112. Different pipe segments 100 may differ in at least one of the pitch X of the ring portion 111, the length Y of the beam portion 112, the width D of the recess 120, and the combined length of adjacent recesses 120 and the beam portion 112. The length Y of the beam portion 112 is the dimension of the beam portion 112 along the extension direction of adjacent recesses 120, the length of the recess 120 is the dimension of the recess 120 along the extension direction, and the width D of the recess 120 is the distance between two opposing side surfaces of the recess 120 in the normal direction of the recess 120.

[0074] For reference Figure 5-Figure 7 , Figure 5-Figure 7 Three different pipe segments 100 are shown (hereinafter referred to as a first pipe segment 101, a second pipe segment 102, and a third pipe segment 103). At least two of the pipe segments 100 have at least one different parameter including the pitch X of the ring portion 111, the length Y of the beam portion 112, the width D of the recess 120, and the combined length of adjacent recesses 120 and beam portions 112. This allows each pipe segment 100 to have a different stiffness, thereby ensuring that each pipe segment 100 has the required stiffness and flexibility, and has good traceability and accessibility.

[0075] It should be noted that the thread-shaped recesses 120 are Figure 5-Figure 7 The spiral should be distributed around the main body 110, however, Figure 5-Figure 7 When the inclination of the spiral concave portion 120 is small, it looks like they are all arranged approximately parallel to the vertical direction. Those skilled in the art will understand that Figure 5-Figure 7 The recesses 120 are actually distributed in a spiral shape.

[0076] In related art hypotubes, the stiffness of two adjacent segments 100 may change suddenly, which can easily cause the human body lumen at the junction of the two segments 100 to adapt to two bending radii. This can easily cause the junction to become stuck in the lumen, potentially damaging or even rupturing the lumen at the junction. Therefore, in some possible embodiments, the stiffness of the multiple segments 100 of the hypotube gradually increases from the distal end A to the proximal end B of the hypotube.

[0077] In this embodiment, the proximal end B is the end closest to the operator, and the distal end A is the end extending into the vascular system. The stiffness of the multiple hypotube segments 100 gradually increases from the distal end A to the proximal end B. Furthermore, the stiffness of each segment 100 at different locations can also vary sequentially from the proximal end B to the distal end A, resulting in a gradual change in the stiffness of the hypotube. This allows for smoother insertion and rotation within the body, helping the catheter provide necessary support at specific locations while maintaining sufficient flexibility in other areas to adapt to the curves of the body.

[0078] In some possible embodiments, in at least one tube segment 100 , at least one recess 120 extends along the circumference of the main body 110 to form an annular distribution. The annularly distributed recess 120 is closer to the proximal end B than the helically distributed recess 120 .

[0079] In this embodiment, the recesses 120 extend along the circumference of the main body 110 in one or more tube segments 100, forming an annular distribution. The hypotube in this embodiment utilizes a combination of annular and helical recesses 120, which improves the adaptability of the catheter and makes it suitable for complex lesions.

[0080] This application also provides specific pattern parameters for some hypotubes. In some possible embodiments, the central angle corresponding to the combination structure of adjacent recesses 120 and beams 112 is not less than 90 degrees and not greater than 115 degrees.

[0081] The pitch X of the ring portion 111 is not less than 0.02 mm and not more than 0.25 mm.

[0082] The width D of the recess 120 is not less than 0.011 mm and not more than 0.018 mm.

[0083] The central angle corresponding to the beam portion 112 is not less than 8 degrees and not more than 16 degrees.

[0084] In this embodiment, the combined structure of the recess 120 and an adjacent beam 112 can be abstracted as an arc length, and the central angle corresponding to the arc length is not less than 90 degrees and not more than 115 degrees. The hypotube provided in this embodiment focuses on the property of stiffness. The central angle corresponding to the combined structure of the recess 120 and an adjacent beam 112 is not less than 90 degrees and not more than 115 degrees, the pitch X of the ring 111 is not less than 0.02 mm and not more than 0.25 mm, the width D of the recess 120 is not less than 0.011 mm and not more than 0.018 mm, and the central angle corresponding to the beam 112 is not less than 8 degrees and not more than 16 degrees. This makes the hypotube stiffness distribution more uniform, optimizes torque transmission, and reduces axial adverse effects.

[0085] In some possible embodiments, the outer diameter of the main body 110 is no greater than 0.125 mm.

[0086] The central angle corresponding to the combination structure of adjacent recesses 120 and beams 112 is not less than 70 degrees and not greater than 110 degrees.

[0087] The pitch X of the ring portion 111 is not less than 0.05 mm and not more than 1 mm.

[0088] The width D of the recess 120 is not less than 0.001 mm and not more than 0.006 mm.

[0089] The central angle corresponding to the beam portion 112 is not less than 3 degrees and not more than 50 degrees.

[0090] The hypotube provided in this embodiment is more suitable for situations where the outer diameter of the main body 110 is no greater than 0.125. The central angle corresponding to the combined structure of the recess 120 and an adjacent beam 112 is no less than 70 degrees and no greater than 110 degrees, the pitch X of the ring 111 is no less than 0.05 mm and no greater than 1 mm, the width D of the recess 120 is no less than 0.001 mm and no greater than 0.006 mm, and the central angle corresponding to the beam 112 is no less than 3 degrees and no greater than 50 degrees. This ensures that the hypotube has a more uniform stiffness distribution while maintaining the outer diameter of the main body 110 no greater than 0.125, thereby optimizing torque transmission and reducing axial adverse effects.

[0091] Optionally, among the multiple tube segments 100, parameters of the hypotube such as the pitch X of the ring portion 111, the length Y of the beam portion 112, the width D of the recess 120, and the combined length of any recess 120 and an adjacent beam portion 112 can be changed in a certain manner. For example, along the direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 can be gradually changed in a certain manner, or the length Y of the beam portion 112 can be gradually changed in a certain manner, or the width D of the recess 120 can be gradually changed in a certain manner, or the combined length of any recess 120 and an adjacent beam portion 112 can also be gradually changed in a certain manner. The stiffness of the resulting hypotube also changes gradually, making the pushing and rotation of the catheter in the body smoother.

[0092] In some possible embodiments, such as Figure 4 As shown, the width D of the recess 120 of the tube segment 100 near the distal end A of the hypotube (D of the recess in the tube segment 100 near the distal end A is equal to D+δD) is greater than the width D of the recess 120 of the tube segment 100 near the proximal end B of the hypotube.

[0093] In this embodiment, without considering other parameters, or in other words, when other parameters remain constant, the recess 120 near the distal end A is wider, and the recess 120 near the proximal end B is narrower, so that the pipe section 100 near the distal end A is softer and more flexible, and the pipe section 100 near the proximal end B is harder and easier to control.

[0094] In some possible embodiments, the length of the recess 120 of the tube segment 100 near the distal end A of the hypotube is greater than the length of the recess 120 of the tube segment 100 near the proximal end B of the hypotube.

[0095] In this embodiment, without considering other parameters, or in other words, when other parameters remain constant, the recess 120 near the distal end A is longer, and the recess 120 near the proximal end B is shorter, so that the pipe section 100 near the distal end A is softer and more flexible, and the pipe section 100 near the proximal end B is harder and easier to control.

[0096] In some possible embodiments, such as Figure 2 As shown, the pitch X of the ring portion 111 of the tube segment 100 near the distal end A of the hypotube is smaller than the pitch X of the ring portion 111 of the tube segment 100 near the proximal end B of the hypotube (the pitch X of the ring portion 111 in the tube segment 100 near the proximal end B is equal to X+δX).

[0097] In this embodiment, without considering other parameters, or in other words, when other parameters are constant, the pitch X of the ring portion 111 in the pipe segment 100 of the hypotube close to the distal end A is smaller than the pitch X of the ring portion 111 in the pipe segment 100 of the hypotube close to the proximal end B, so that the pipe segment 100 close to the distal end A is more flexible and more agile, and the pipe segment 100 close to the proximal end B is more rigid and easier to control.

[0098] In some possible embodiments, such as Figure 3 As shown, the length Y of the beam portion 112 of the tube segment 100 near the distal end A of the hypotube is smaller than the length Y of the beam portion 112 of the tube segment 100 near the proximal end B of the hypotube (the length Y of the beam portion 112 in the tube segment 100 near the proximal end B is equal to Y+δY).

[0099] In this embodiment, without considering other parameters, or in other words, when other parameters are constant, the length Y of the beam portion 112 of the hypotube segment 100 near the distal end A is shorter than the length Y of the beam portion 112 of the hypotube segment 100 near the proximal end B. This makes the beam portion 112 of the hypotube segment 100 near the distal end A shorter and more flexible. The segment 100 near the proximal end B is harder, which can enhance torque response.

[0100] Next, the embodiment of the present application divides the pipe segment 100 into a specific first pipe segment 101 , a second pipe segment 102 , and a third pipe segment 103 to illustrate how the parameters in each pipe segment 100 change.

[0101] In some possible embodiments, such as Figure 5 As shown, the hypotube includes a first tube section 101 near the distal end A.

[0102] In the first tube section 101 , along the extension direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 increases sequentially in a first design manner, and the length Y of the beam portion 112 remains unchanged.

[0103] In this embodiment, the first tube segment 101 is close to the distal end A and is transported in the vascular system. In the first tube segment 101, along the direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 increases sequentially in the first design manner, and the length Y of the beam portion 112 remains unchanged, so that the first tube segment 101 gradually becomes harder in the direction from the distal end A to the proximal end B.

[0104] like Figure 5 As shown, Figure 5 X refers to the pitch X of one ring portion 111 , and X+δX refers to the pitch X of an adjacent ring portion 111 . From left to right, the length of the ring portion 111 increases by δX, that is, the ring portion 111 increases linearly. Figure 5 Y refers to the length Y of one beam portion 112 , and the length Y of the beam portion 112 in the entire first pipe section 101 remains unchanged.

[0105] In some possible embodiments, such as Figure 6 As shown, the hypotube includes a second tube section 102 that is further away from the distal end A than the first tube section 101 .

[0106] In the second tube section 102 , along the extension direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 increases in the second design manner, and the length Y of the beam portion 112 increases in the third design manner.

[0107] In this embodiment, the second tube segment 102 is farther away from the distal end A than the first tube segment 101. Along the direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 is increased in the second design manner, and the length Y of the beam portion 112 is increased in the third design manner, that is, the lengths Y of both the ring portion 111 and the beam portion 112 are increased, so that the second tube segment 102 gradually becomes harder in the direction from the distal end A to the proximal end B.

[0108] like Figure 6 As shown, Figure 6 X refers to the pitch X of one ring portion 111 , and X+δX refers to the pitch X of an adjacent ring portion 111 . From left to right, the length of the ring portion 111 increases by δX, that is, the ring portion 111 increases linearly. Figure 6 Y refers to the length Y of one beam portion 112 , and Y+δY refers to the length Y of an adjacent beam portion 112 . From left to right, the length of the beam portion 112 increases by δY in sequence, that is, the beam portion 112 increases linearly.

[0109] It can be understood that along the extension direction of the waveguide (i.e. Figure 6 The entire recess 120 may exist between two adjacent beam portions 112 (from left to right).

[0110] In some possible embodiments, the hypotube includes a third tube segment 103 that is closer to the proximal end B than the second tube segment 102 .

[0111] In the third tube section 103 , along the direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 and the length Y of the beam portion 112 remain unchanged.

[0112] In this embodiment, the third tube segment 103 is farther away from the distal end A than the second tube segment 102. In the direction from the distal end A to the proximal end B, the lengths Y of the ring portion 111 and the beam portion 112 remain unchanged, so that the third tube segment 103 has sufficient rigidity, which helps to improve the transmission of torque and enables the operator to more accurately control the direction and position of the hypotube, especially in surgeries requiring delicate operations.

[0113] like Figure 5 As shown, Figure 7X refers to the pitch X of a ring portion 111 , and Y refers to the length Y of a beam portion 112 . The lengths Y of the ring portion 111 and the beam portion 112 remain unchanged throughout the third pipe section 103 .

[0114] In some possible embodiments, the first design mode, the second design mode, and the third design mode each include at least one of a linear mode, an exponential mode, or a logarithmic mode.

[0115] In this embodiment, the first, second, and third design methods can be the same or different, depending on the specific situation. Each design method can be a linear change, an exponential change, a logarithmic change, or other changes not fully described due to space constraints. Each design method provided in this embodiment is easy to implement using laser cutting technology, which is conducive to forming a hypotube with gradually varying stiffness.

[0116] In some possible embodiments, the main body 110 includes a plurality of sub-parts divided along the circumferential direction.

[0117] At least one of the pitch X of the ring portion 111 , the length Y of the beam portion 112 , the width D of the recess 120 , and the combined length of adjacent recesses 120 and beam portions 112 is different between at least two sub-portions.

[0118] In this embodiment, the main body 110 can be divided into a plurality of sub-sections arranged in parallel along the circumference of the main body 110. At least one parameter among the pitch X of the ring portion 111, the length Y of the beam portion 112, the width D of the recess 120, and the combined length of any recess 120 and an adjacent beam portion 112 differs between regions where at least two sub-sections are located. For example, in a cross section perpendicular to the axial direction of the main body 110, the pattern of the hypotube is not symmetrical about the axial direction of the main body 110, but rather has certain differences in the pattern in different sub-sections, making some sub-sections more easily bendable, thereby generating a preferential bending direction at specific locations of the hypotube, making it easier for the hypotube to bend in a predetermined direction and extend into the vascular system, thereby simplifying the directional control of the hypotube.

[0119] It can be understood that the axial direction of the main body 110 is an axis that is consistent with the extension direction of the main body 110 and passes through the center of the main body 110 .

[0120] Please refer to Figure 8-Figure 9 , in some possible embodiments, The width of the recess 120 gradually decreases along the radial direction of the waveguide toward the center.

[0121] In this embodiment, more material is removed from the outer side 114 of the main body 110, while less material is removed from the inner side 113 of the main body 110. This allows the recessed portion 120 to provide additional space for adjacent ring portions to approach each other, further preventing adjacent ring portions 111 from abutting against each other. This, compared to a vertically recessed recessed portion 120, achieves a smaller bending radius. This allows the guidewire to avoid or prevent collisions between rings when passing through tortuous distal intracranial blood vessels, which could result in excessive bending radius of the guidewire and prevent it from reaching the intended lesion location. Therefore, the guidewire further improves flexibility and can conform to the tortuous anatomical structure of the blood vessels, thereby further reducing friction, traction, and nerve damage to the blood vessels.

[0122] Please refer to Figure 8-Figure 9 In some possible embodiments, an angle is formed between two opposite side surfaces of the recess 120 in the extension direction of the hypotube.

[0123] In this embodiment, an angle is formed between the two opposite side surfaces of the recess 120, so that at least one of the two opposite side surfaces of the recess 120 has an angle with the inner surface or outer surface of the adjacent ring portion 111, thereby ensuring the balance of the guide wire's flexibility, tensile strength, torque transmission and other performance, thereby reducing the phenomenon of the guide wire sticking close to the blood vessel wall, reducing the friction during the delivery process, and at the same time ensuring that the pushing force and torque control force are smoothly transmitted from the proximal end of the guide wire to the distal end of the guide wire.

[0124] Based on the same inventive concept, an embodiment of the present application further provides a guidewire, comprising: a core wire, a coil, and any hypotube provided in the above embodiments.

[0125] The coil is wrapped around the outer circumference of the distal end portion of the core wire.

[0126] The hypotube is tubular and is arranged around a portion of the coil and a portion of the core wire.

[0127] The guide wire provided in this embodiment includes any of the hypotubes provided in the above embodiments, and its implementation principle is similar, which will not be repeated here. The hypotube can only cover the sheathed core wire and coil, and the core wire and coil each have a portion exposed from the hypotube, which is determined according to the actual situation. By applying the embodiments of the present application, at least the following beneficial effects can be achieved: 1. The hypotube in the embodiment of the present application includes at least two tube segments 100. The stiffness of the tube segment 100 near the proximal end B of the hypotube is greater than the stiffness of the tube segment 100 near the distal end A of the hypotube. This ensures that each tube segment 100 has the required stiffness and flexibility, providing good traceability and accessibility. Furthermore, the related art uses micromachining techniques such as microsawing or wire cutting to form the recess 120, resulting in the existing hypotube segments 100 having uniform stiffness or difficulty in adjusting. While the proximal end B has sufficient stiffness to push the coil, the distal end A near the coil has excessive stiffness, resulting in an excessively large minimum bending radius, making it difficult to pass through a cavity with a smaller bending radius. The sea wave tube in the embodiment of the present application can use laser cutting technology to form a recess 120 on the main body 110, so that the shape or pattern of the recess 120 is richer, and the cutting parameters are controllable, which is conducive to forming a sea wave tube with good rigidity and flexibility. It can balance the complex bending rigidity requirements, tensile strength requirements and torsional strength requirements of the human vascular system while obtaining a smaller bending radius when changing the shape of the guide wire as needed.

[0128] 2. The number of recesses 120 can be multiple, extending at intervals around the circumference of the main body 110, with the multiple recesses 120 being distributed in a spiral pattern. The present embodiment utilizes laser cutting technology to achieve the pattern of recesses 120, enabling the hypotube to achieve a balance of bendability, rigidity, or flexibility not currently possible using other micromachining technologies.

[0129] 3. The recesses 120 extend along the circumference of the main body 110 in one or more tube segments 100, forming an annular distribution. The hypotube in this embodiment uses a combination of annular and helical recesses 120 to improve the adaptability of the catheter and make it suitable for complex lesions.

[0130] 4. Among the multiple tube segments 100, parameters of the hypotube, such as the pitch X of the ring portion 111, the length Y of the beam portion 112, the width D of the recess 120, and the combined length of any recess 120 and an adjacent beam portion 112, can be varied in a certain manner. For example, along the direction from the distal end A to the proximal end B, the pitch X of the ring portion 111 can be gradually varied in a certain manner, or the length Y of the beam portion 112 can be gradually varied in a certain manner, or the width D of the recess 120 can be gradually varied in a certain manner, or the combined length of any recess 120 and an adjacent beam portion 112 can also be gradually varied in a certain manner. The resulting stiffness of the hypotube also gradually varies, making the pushing and rotation of the catheter in the body smoother.

[0131] In the description of the present application, the directions or positional relationships indicated by words such as "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", and "outside" are based on the exemplary directions or positional relationships shown in the accompanying drawings. They are for the convenience of describing or simplifying the description of the embodiments of the present application, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on the present application.

[0132] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature specified as "first" or "second" may explicitly or implicitly include one or more of such features. Throughout this application, unless otherwise specified, "plurality" means two or more.

[0133] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to direct connections, indirect connections through an intermediate medium, or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0134] In the description of this specification, specific features, structures, materials or characteristics may be combined in an appropriate manner in any one or more embodiments or examples.

[0135] The above is only part of the implementation methods of the present application. It should be pointed out that for ordinary technicians in this technical field, without departing from the technical concept of the solution of the present application, other similar implementation methods based on the technical ideas of the present application also fall within the protection scope of the embodiments of the present application.

Claims

1. A hypotube, used for a guidewire, characterized in that: The hypotube comprises at least two tube sections sequentially distributed along the extension direction of the hypotube; the hypotube comprises: a main body and a recessed portion formed in the main body; In at least one of the pipe sections, at least one of the recesses extends on the circumference of the body portion to form a spiral distribution, including a plurality of thread segments arranged along the extension direction of the recess; Along the extension direction of the hypotube, the body portion between adjacent thread segments forms a ring portion; The stiffness of the tube section near the proximal end of the hypotube is greater than the stiffness of the tube section near the distal end of the hypotube; At least one of the pitch of the ring portion and the width of the recess is different between different pipe sections; the width of the recess is the distance between two opposite side surfaces of the recess perpendicular to the extending direction of the recess.

2. The hypotube according to claim 1, wherein: The number of the recess is one, spirally surrounding at least two of the pipe segments.

3. The hypotube according to claim 1, wherein: There are multiple recesses; In at least one of the tube sections, at least two of the recesses extend on the circumference of the main body at intervals to form a spiral distribution; Along the extending direction of the recessed portion, the body portion between adjacent recessed portions forms a beam portion; At least one of the length of the beam portion and the combined length of the adjacent recesses and the beam portion is different between different pipe sections; the length of the beam portion is the dimension of the beam portion along the extension direction of the adjacent recesses, and the length of the recess is the dimension of the recess along the extension direction of the recess.

4. The hypotube according to claim 1, wherein: The stiffness of the multiple tube sections of the sea wave tube gradually increases from the distal end of the sea wave tube to the proximal end of the sea wave tube.

5. The hypotube according to claim 1, wherein: In at least one of the tube sections, at least one of the recesses extends along the circumference of the main body to form an annular distribution, and the annularly distributed recesses are closer to the proximal end than the helically distributed recesses.

6. The hypotube according to claim 3, characterized in that: The central angle corresponding to the combined structure of the adjacent recesses and beams is not less than 90 degrees and not more than 115 degrees; The pitch of the ring portion is not less than 0.02 mm and not more than 0.25 mm; The width of the recess is not less than 0.011 mm and not more than 0.018 mm; The central angle corresponding to the beam portion is not less than 8 degrees and not more than 16 degrees.

7. The hypotube according to claim 3, wherein: The outer diameter of the main body is not greater than 0.125 mm; The central angle corresponding to the combined structure of the adjacent recesses and the beams is not less than 70 degrees and not more than 110 degrees; The pitch of the ring portion is not less than 0.05 mm and not more than 1 mm; The width of the recess is not less than 0.001 mm and not more than 0.006 mm; The central angle corresponding to the beam portion is not less than 3 degrees and not more than 50 degrees.

8. The hypotube according to claim 3, wherein: The width of the recessed portion of the tube section near the distal end of the hypotube is greater than the width of the recessed portion of the tube section near the proximal end of the hypotube.

9. The hypotube according to claim 3, wherein: The length of the recessed portion of the tube section near the distal end of the hypotube is greater than the length of the recessed portion of the tube section near the proximal end of the hypotube.

10. The hypotube according to claim 3, wherein: The pitch of the ring portion of the tube section near the distal end of the hypotube is smaller than the pitch of the ring portion of the tube section near the proximal end of the hypotube.

11. The hypotube according to claim 3, wherein: The length of the beam portion of the tube section close to the distal end of the hypotube is smaller than the length of the beam portion of the tube section close to the proximal end of the hypotube.

12. The hypotube according to claim 3, wherein: The hypotube includes a first tube section near the distal end; In the first tube section, along the extension direction from the distal end to the proximal end, the pitch of the ring portion increases sequentially in a first design manner, and the length of the beam portion remains unchanged.

13. The hypotube according to claim 12, wherein: The hypotube further comprises a second tube segment further away from the distal end than the first tube segment; In the second tube section, along the extension direction from the distal end to the proximal end, the pitch of the ring portion increases in a second design manner, and the length of the beam portion increases in a third design manner.

14. The hypotube according to claim 13, wherein: The hypotube further includes a third tube segment closer to the proximal end than the second tube segment; In the third tube section, along the direction from the distal end to the proximal end, the pitch of the ring portion and the length of the beam portion remain unchanged.

15. The hypotube according to claim 14, wherein: The first design mode, the second design mode, and the third design mode each include at least one of a linear mode, an exponential mode, or a logarithmic mode.

16. The hypotube according to claim 1, wherein: The main body portion includes a plurality of sub-portions divided along the circumferential direction; At least one of the pitch of the ring portion, the length of the beam portion, the width of the recess, and the combined length of adjacent recesses and the beam portion is different between at least two of the sub-portions.

17. The hypotube according to claim 1, wherein: Along the radial direction of the hypotube toward the center of the circle, the width of the recess gradually decreases.

18. The hypotube according to claim 17, wherein: In the extension direction of the hypotube, an angle is formed between two opposite side surfaces of the recess.

19. A guide wire, characterized in that: include: A core wire, a coil, and a hypotube as claimed in any one of claims 1 to 18; The coil is wrapped around the outer periphery of the distal end portion of the core wire; The hypotube is tubular and is sleeved around a portion of the coil and a portion of the core wire.

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