Hypotube and microguidewire having the same

Abstract

The present invention provides a hypotube, which includes a distal uncut section, an intermediate cut section, and a proximal uncut section in order from the distal side to the proximal side in the axial direction, wherein the intermediate cut section is arranged with a plurality of pattern units formed by slots in the axial direction, and the intermediate cut section is divided into a first section, a second section, and a third section in order from the distal side to the proximal side in the axial direction, wherein the first section has a constant first axial pitch, the second section has a variable second axial pitch, the third section has a constant third axial pitch, and the first axial pitch is smaller than the third axial pitch, and the second axial pitch varies with its axial position, so that the second axial pitch gradually increases from the first axial pitch to the third axial pitch in the axial direction. The present invention also provides a micro guidewire, which includes the hypotube as described above.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, in particular to a hypotube and a microguidewire having the hypotube. Background Art

[0002] Microguidewire is an interventional diagnostic and treatment device widely used in the medical field. It is used to be inserted into a microcatheter to provide guidance and support. It is usually expected that the head end of the microguidewire, that is, the end that enters the human body, is usually also called the distal end, is relatively soft, so as to facilitate selective entry into the blood vessel and minimize damage to the blood vessel as much as possible; at the same time, it is expected that the tail end, that is, the end close to the operator, is usually also called the proximal end, is relatively hard, so as to play a good supporting role.

[0003] The micro guidewire is mainly composed of a guidewire, a torque controller and a wire pass needle, wherein the guidewire is composed of a core wire, a winding wire and a hypotube, the hypotube surrounds the core wire and the winding wire, and is connected to the core wire by bonding. As an important functional component of the micro guidewire, the hypotube plays a key role in the function of the micro guidewire. Those skilled in the art have been seeking to optimize its design in order to minimize damage to blood vessels while improving the twist control of the guidewire and accurately twisting and controlling the bends. Summary of the invention

[0004] The object of the present invention is to provide a hypotube with an optimized design, which can provide good flexibility (distal end) so that the hypotube can pass through more tortuous blood vessels and minimize damage to the blood vessels.

[0005] Another object of the present invention is to provide a hypotube with an optimized design, which can provide good support (proximal end) so as to effectively transmit the proximal pushing force to the distal end.

[0006] Another object of the present invention is to provide a hypotube with an optimized design, which can take into account both flexibility and support by providing a smoother transition section to provide better torsion control.

[0007] Another object of the present invention is to provide a hypotube with an optimized design that can provide a stronger bond with the internal core wire.

[0008] According to one aspect of the present invention, a hypotube is provided, wherein the hypotube comprises a distal uncut segment, an intermediate cut segment, and a proximal uncut segment in order from the distal side to the proximal side in the axial direction, wherein the intermediate cut segment is provided with a plurality of pattern units formed by slots in the axial direction, wherein the slots have an axial slot width and a slot angle corresponding to a circumferential length, and the difference between the axial positions of two adjacent pattern units is defined as an axial pitch, and the intermediate cut segment is divided into a first segment, a second segment, and a third segment in order from the distal side to the proximal side in the axial direction, wherein:

[0009] The first segment has a constant first axial pitch,

[0010] The second segment has a second varying axial pitch,

[0011] The third segment has a constant third axial pitch, and

[0012] The first axial pitch is smaller than the third axial pitch, and the second axial pitch varies with its axial position such that the second axial pitch gradually increases from the first axial pitch to the third axial pitch along the axial direction.

[0013] According to a preferred embodiment of the present invention, the pattern units in the first section are identical to each other, the pattern units in the second section regularly transition from the pattern units in the first section to the pattern units in the third section, and the pattern units in the third section are identical to each other.

[0014] According to a preferred embodiment of the present invention, the slots at the same axial position form a pattern sub-unit, and the pattern unit includes a plurality of pattern sub-units arranged at different axial positions, wherein the plurality of pattern sub-units of the pattern unit are distributed at equal intervals along the axial direction.

[0015] According to a preferred embodiment of the present invention, the pattern unit includes two pattern sub-units, and the difference between the axial positions of the two pattern sub-units is defined as a sub-pitch, which is half of the axial pitch (DN) between the pattern unit and the pattern unit on the adjacent side.

[0016] According to a preferred embodiment of the present invention, the pattern subunit has a pattern arrangement formed by two or more identical slots evenly distributed circumferentially, and the multiple pattern subunits in the pattern unit have the same pattern arrangement but are circumferentially offset by a first offset angle in sequence along the same direction.

[0017] According to a preferred embodiment of the present invention, the first slotting angle in the first section is greater than the third slotting angle in the third section, and the second slotting angle in the second section decreases from the first slotting angle to the third slotting angle in an arithmetic progression.

[0018] According to a preferred embodiment of the present invention, the pattern units are circumferentially offset by a second offset angle in sequence from the distal side to the proximal side.

[0019] According to a preferred embodiment of the present invention, the second offset angle is oriented in the same direction as the first offset angle.

[0020] According to a preferred embodiment of the present invention, a step portion is provided at the proximal side of the proximal uncut section.

[0021] According to a preferred embodiment of the present invention, the number of the pattern units in the first segment, the second segment, and the third segment in the middle cutting segment is determined according to the corresponding axial length and axial pitch.

[0022] According to a preferred embodiment of the present invention, the second axial pitch is an exponential function of its axial position, that is, changes according to the following function:

[0023] DN2=a*10 -5 *X 2 -b*X+c,

[0024] Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch.

[0025] According to a preferred embodiment of the present invention, a is between 1 and 9, b is between 0.0002 and 0.001, and c is between 0.1 and 0.5.

[0026] According to a preferred embodiment of the present invention, the second axial pitch is a logarithmic function of its axial position, that is, changes according to the following function:

[0027] DN2=d*Ln(X)+e,

[0028] Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch.

[0029] According to a preferred embodiment of the present invention, d is between 0.03 and 0.1, and e is between (-0.02) and (-0.08).

[0030] According to a preferred embodiment of the present invention, d is between 0.03 and 0.1, and e is between 0.002 and 0.015.

[0031] According to a preferred embodiment of the present invention, the second axial pitch is a linear function of its axial position, that is, changes according to the following function:

[0032] DN2=f*X+g;

[0033] Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch.

[0034] According to a preferred embodiment of the present invention, f is between 0.001 and 0.003, and g is between 0.1 and 0.3.

[0035] According to another aspect of the present invention, a micro guidewire is provided, the micro guidewire comprising a hypotube as described above, the hypotube being arranged to surround a core wire and a winding wire of the micro guidewire. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Embodiments of the present invention will be described below by way of example only with reference to the accompanying drawings. In the drawings, like features or components are indicated by like reference numerals, and the drawings are not necessarily drawn to scale. In the drawings:

[0037] Figure 1 is a front view of a hypotube according to an embodiment of the present invention (including a step portion);

[0038] Figure 2 is a front view of a hypotube according to another embodiment of the present invention (excluding the step portion);

[0039] Figure 3 is a circumferential development view of a portion of a hypotube according to an embodiment of the present invention, showing a plurality of pattern units;

[0040] Figure 4 is a schematic diagram of a micro guidewire according to an embodiment of the present invention; and

[0041] Figure 5 is a partial cross-sectional view of a micro guidewire according to an embodiment of the present invention. DETAILED DESCRIPTION

[0042] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.The materials, methods, and examples described herein are illustrative only and not intended to be limiting.

[0043] The term “comprise” or variations thereof such as “comprising”, “having” or “including” means including stated steps or elements but not excluding any other steps or elements.

[0044] When a numerical range is mentioned, it should be deemed to specifically disclose the specific values ​​of its upper and lower limits, as well as all intermediate ranges included therein, such as the intermediate range between its upper or lower limit and any intermediate value, or the intermediate range between any two intermediate values ​​thereof. In addition, any intermediate range, subrange and all individual values ​​described in the numerical range can be excluded from the numerical range described.

[0045] The “and / or” described herein should be understood as any one element or any combination of several elements connected by this term.

[0046] The various technical features of the different implementations to be described below can be combined in any way. To make the description concise, not all these possible combinations are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0047] In this document, when the "proximal end" or "proximal side" is mentioned, it usually refers to the end or side close to the operator, or it can also be called the operating end or operating side; when the "distal end" or "distal side" is mentioned, it usually refers to the end or side away from the operator, in other words, the end or side that can enter the patient's body, or it can also be called the entry end or entry side. In the drawings of this application, unless otherwise stated, the "left" of the view is in the direction of the above-mentioned "distal end" or "distal side", and the "right" of the view is in the direction of the above-mentioned "proximal end" or "proximal side".

[0048] After reading the specific embodiments of the present invention in conjunction with the accompanying drawings, other features and advantages of the present invention will become more clear.

[0049] The basic structure and dimensions of the hypotube:

[0050] First, the general structure of the hypotube will be described with reference to the accompanying drawings.

[0051] In this specification, the hypotube is generally referred to by reference numeral 10. The hypotube 10 is generally made of nickel-titanium alloy (NiTi) (GB 24627-2009 / ASTM F2063-05), and can be made into a thin-walled tubular body of different specifications (outer diameter / wall thickness) to adapt to guidewires used in different use environments.

[0052] Preferably, the outer diameter of the hypotube may be between about 0.1239 mm and 0.4343 mm.

[0053] Usually, refer to Figure 1 and Figure 2 The hypotube 10 includes a distal uncut section 100, a middle cut section 200, and a proximal uncut section 300 from the distal side to the proximal side in the axial direction L. The distal uncut section 100 is used to connect a balloon or other surgical tools to perform corresponding surgical operations; the proximal uncut section 300 is used for the operator to apply force. The lengths of the distal uncut section 100 and the proximal uncut section 300 are relatively small, and the middle cut section 200 occupies a considerable portion of the total length of the hypotube 10.

[0054] As shown in the figure, the middle cutting section 200 is provided with a plurality of slots S, each of which extends in the circumferential direction and is arranged at a plurality of axial positions. Due to the presence of these slots S, the hypotube 10 has both corresponding flexibility and sufficient support to effectively transmit the proximal pushing force to the distal end. These slots S can be cut sequentially by machining methods such as laser cutting.

[0055] In this article, for the convenience of description, a reference coordinate system is defined, wherein the distal starting point of the middle cutting segment 200 is defined as the origin of the reference coordinate system, the axial direction L is defined as the horizontal axis, and the circumferential direction after expansion is defined as the vertical axis. Therefore, the axial distance between any point on the middle cutting segment 200 and the distal starting point of the middle cutting segment 200 can be understood as the horizontal coordinate X of the point in the reference coordinate system, which can also be called the axial position X of the point on the middle cutting segment 200, or simply the axial position X of the point.

[0056] Reference Figure 3 The slot S is mainly characterized by the following indicators: (1) its slot width sw in the axial direction, and (2) its angle A corresponding to its length in the circumferential direction. At the same time, the circumferential distribution of each slot at the same axial position, together with the slot width sw and angle A of the slot, jointly define a pattern arrangement.

[0057] Preferably, the axial width sw of the slot S may be between about 0.01 mm and 0.05 mm.

[0058] Preferably, all the slots S on the middle cutting segment 200 have the same axial slot width sw.

[0059] It is understandable that the slots S on the middle cutting section 200 may also have different axial slot widths sw. For example, the axial slot width sw of the slot S closer to the distal end may be larger, and the axial slot width sw of the slot S closer to the proximal end may be smaller.

[0060] Preferably, at the same axial position on the middle cutting segment 200 , two identical slots evenly distributed in the circumferential direction may be arranged, that is, two slots with the same slot width sw and the same angle A.

[0061] It is understandable that other arrangements are also feasible. For example, at the same axial position on the middle cutting segment 200, three or more identical slots evenly distributed along the circumferential direction may be arranged; or, at the same axial position on the middle cutting segment 200, only one slot may be arranged, in which case, the circumferential positions of the two slots at two adjacent axial positions are substantially opposite.

[0062] The following will take the pattern arrangement of two identical slots evenly distributed along the circumferential direction at the same axial position as an example for explanation. It can be understood that at the same axial position, there are also two identical unslotted portions evenly distributed along the circumferential direction, which are referred to as bridge portions U hereinafter.

[0063] In this example, the axial position (X) of the slot S is defined by its distal starting point, and multiple axial positions where the slots are arranged are respectively defined as the first, second, third, fourth... axial positions from distal to proximal, wherein the first axial position is the distal starting point of the middle cutting segment 200, that is, the horizontal coordinate X=0 of the first axial position.

[0064] Furthermore, the pattern arrangement at each axial position can be defined as a pattern sub-unit PS, wherein the pattern arrangement at the first axial position is repeated at the second axial position, but is circumferentially offset by a first offset angle α1 in a clockwise (or counterclockwise) direction; the third axial position can have a pattern arrangement different from that at the first axial position, and similarly, the pattern arrangement at the third axial position is repeated at the fourth axial position, but is circumferentially offset by a first offset angle α1 in a clockwise (or counterclockwise) direction... and so on. Thus, the pattern sub-units at the first axial position and the second axial position together form a pattern unit P, and the pattern sub-units at the third axial position and the fourth axial position together form a pattern unit P... and so on.

[0065] Preferably, the first offset angle α1 may be between 60 and 120 degrees.

[0066] In the above example, each pattern unit P includes two pattern sub-units having the same pattern arrangement. It is understood that each pattern unit P may also include other numbers of pattern sub-units, for example, only one pattern sub-unit, or three or more pattern sub-units. The first offset angles α1 between the pattern sub-units in different pattern units P may also be different.

[0067] Here, the axial position or circumferential position of each pattern unit is defined by the slot S on the relatively far side (closer to the origin of the reference coordinate system). At the same time, the difference between the axial positions of two adjacent pattern units P (i.e., the difference between the horizontal coordinates in the reference coordinate system) is defined as the axial pitch DN, and the difference between the axial positions of two adjacent pattern sub-units PS in each pattern unit (i.e., the difference between the horizontal coordinates in the reference coordinate system) is defined as the sub-pitch G.

[0068] Preferably, the sub-pitch G may be designed such that a plurality of pattern sub-units of each pattern unit P are distributed at equal intervals along the axial direction.

[0069] The middle cutting section 200 can be divided into a first section 210 , a second section 220 and a third section 230 in sequence from the distal side to the proximal side along the axial direction L.

[0070] Preferably, the first segment 210 has a constant first axial pitch DN1, the second segment 220 has a variable second axial pitch DN2, and the third segment 230 has a constant third axial pitch DN3. Therefore, the second segment 220 can also be understood as a transition segment between the first segment 210 and the third segment 230.

[0071] Preferably, the first axial pitch DN1 may be between about 0.1 mm and 0.3 mm.

[0072] Preferably, the third axial pitch DN3 may be between about 0.2 mm and 0.6 mm.

[0073] Preferably, the first axial pitch DN1 is smaller than the third axial pitch DN3, and the second axial pitch DN2 varies according to its axial position so that the second axial pitch DN2 gradually increases from the first axial pitch DN1 to the third axial pitch DN3 in a smooth manner from distal to proximal.

[0074] In this article, when it is mentioned that the first axial pitch DN1 gradually increases to the third axial pitch DN3, it does not mean that the second axial pitch DN2 gradually increases from a value exactly equal to the first axial pitch DN1 to a value exactly equal to the third axial pitch DN3. Instead, it can be understood that the second axial pitch DN2 gradually increases from a value closer to the first axial pitch DN1 to a value closer to the third axial pitch DN3.

[0075] Preferably, the second axial pitch DN2 may be an exponential function of its axial position, that is:

[0076] DN2=a*10 -5 *X 2 -b*X+c,------Formula 1

[0077] Wherein, X is the axial position of the relatively far-side pattern unit involved in the second axial pitch, and more preferably, a is between 1 and 9, b is between 0.0002 and 0.001, and c is between 0.1 and 0.5.

[0078] Preferably, the second axial pitch DN2 may be a logarithmic function of its axial position, that is:

[0079] DN2=d*Ln(X)+e, ------Formula 2

[0080] Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch, and more preferably, d is between 0.03 and 0.1, and e is between (-0.02) and (-0.08), or, d is between 0.03 and 0.1, and e is between 0.002 and 0.015.

[0081] Preferably, the second axial pitch DN2 may be a linear function of its axial position, that is:

[0082] DN2=f*X+g;------Formula 3

[0083] Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch, and more preferably, f is between 0.001 and 0.003, and g is between 0.1 and 0.3.

[0084] Preferably, the number of corresponding pattern units in the first segment 210 , the second segment 220 , and the third segment 230 in the middle cutting segment 200 can be determined according to the required axial length and the preset axial pitch.

[0085] Preferably, all pattern units in the first section 210 are identical to each other, all pattern units in the second section 220 regularly transition from pattern units in the first section to pattern units in the third section, and pattern units in the third section 230 are identical to each other.

[0086] It can be understood that all pattern units in the first section 210 may not be completely the same, and all pattern units in the third section 230 may not be completely the same.

[0087] Preferably, the sub-pitch G in each pattern unit P is half of the axial pitch DN between the pattern unit and the pattern unit on its adjacent side.

[0088] Furthermore, the angle corresponding to the circumferential length of the slot S in each pattern unit is defined as the slot angle A, and the angle corresponding to the circumferential length of the bridge U is defined as the bridge angle B. It can be understood that in this example, there is the following equation:

[0089] A+B=180°.

[0090] Preferably, the first segment 210 has a constant first slotting angle A1, the second segment 220 has a variable second slotting angle A2, and the third segment 230 has a constant third slotting angle A3; accordingly, the first segment 210 has a constant first bridge angle B1, the second segment 220 has a variable second bridge angle B2, and the third segment 230 has a constant third bridge angle B3.

[0091] Preferably, the first slotting angle A1 is greater than the third slotting angle A3, and the second slotting angle A2 decreases from the distal side to the proximal side in an arithmetic progression, thereby transitioning from the first slotting angle A1 to the third slotting angle A3; accordingly, the first bridge angle B1 is less than the third bridge angle B3, and the second bridge angle B2 increases from the distal side to the proximal side in an arithmetic progression, thereby transitioning from the first bridge angle B1 to the third bridge angle B3.

[0092] Preferably, the first slotting angle A1 in the first section 210 may be between 140 degrees and 170 degrees.

[0093] Preferably, the second slot angle A2 in the second section 220 may decrease in an arithmetic progression with a tolerance between 0.03 and 0.3.

[0094] Preferably, the third slotting angle A3 in the third segment 230 may be between 100 and 150 degrees.

[0095] Preferably, the pattern units in the axial direction are circumferentially offset by a second offset angle α2 in sequence from the distal side to the proximal side.

[0096] Preferably, the second offset angle α2 may be between 10 and 30 degrees.

[0097] Preferably, the second offset angle α2 can be oriented in the same direction as the first offset angle α1, that is, if the pattern sub-units are offset in a clockwise direction from the far side to the near side, the pattern units are also offset in a clockwise direction from the far side to the near side, and vice versa.

[0098] Preferably, the axial length of the proximal uncut section 300 may be about 0.4 mm to 0.8 mm, and a step portion 310 is provided at the proximal side of the proximal uncut section 300. Figure 1 As shown, the size of the step portion 310 can be adapted to the size of the proximal uncut section 300 .

[0099] In the above, although the value ranges of relevant parameters are given, those skilled in the art will understand that this does not mean that each parameter can take arbitrarily values ​​within its corresponding range. In fact, the values ​​of each parameter are interrelated, that is, in addition to being within its corresponding value range and meeting the requirements of actual application, its value must be based on the premise of being able to realize the technical solution defined in this application. For example, the values ​​of the coefficients in Formulas 1 to 3 above must be able to ensure that the second axial pitch DN2 gradually increases from the first axial pitch DN1 to the third axial pitch DN3 in a smooth manner.

[0100] The preferred embodiments of the present invention will be further described in detail below by way of examples. It is understood that although specific dimensions are listed in the following examples, different dimensions in different examples can be combined according to actual needs or usage scenarios, and these combinations should be considered to be within the scope of this specification.

[0101] 1. First implementation mode (NC1):

[0102] In this preferred embodiment, reference Figure 1 and Figure 3 The outer diameter OD of the hypotube 10 is 0.312 mm, and the total axial length is about 274 mm, wherein the axial length of the proximal uncut section 300 is about 0.68 mm, and the axial slot width sw of the slot S is 0.036 mm. The first offset angle α1 of the clockwise circumferential offset of the first pattern subunit PS1 and the second pattern subunit PS2 inside the pattern unit P is 75 degrees, and the second offset angle α2 of the clockwise circumferential offset of the pattern units from the distal side to the proximal side is about 20 degrees.

[0103] First paragraph 210:

[0104] The first section 210 has 65 repeated pattern units P, and the first axial pitch DN1 is 0.23 mm. Therefore, the axial length of the first section 210 is 14.95 (= 0.23 * 65) mm. Accordingly, the sub-pitch G1 in the pattern units in the first section 210 is 0.115 mm.

[0105] In addition, the first slot angle A1 of the first section 210 is 150 degrees, and correspondingly, the first bridge angle B1 is 30 degrees.

[0106] Paragraph 220:

[0107] The second segment 220 has 286 repeated pattern units P, and the second axial pitch DN2 varies according to the above formula 1:

[0108] DN2(i)=a*10 -5 *X 2 -b*X+c,

[0109] Among them, a = 2, b = 0.0005, c = 0.234,

[0110] Wherein, i is a natural number sequence, which is the ordinal number of the pattern unit on the relatively far side (closer to the origin of the reference coordinate system) involved in the second axial pitch arranged from the far side to the near side among all the pattern units, and X is the horizontal coordinate (X) of the pattern unit P(i) on the relatively far side (closer to the origin of the reference coordinate system), which is still used for other embodiments.

[0111] For example, in this embodiment, the abscissa of the starting position of the second section 220 is 14.95 mm: that is, the abscissa (X) of the 66th pattern unit P(66) (the first pattern unit in the second section 220) is 14.95 (=65*0.23) mm, and the second axial pitch DN2(66) between the 66th pattern unit P(66) and the 67th pattern unit P(67) is:

[0112] DN2(66)=(2x10 -5 )14.95 2 -0.0005*14.95+0.234=0.231,

[0113] Accordingly, the sub-pitch G(66) in the pattern unit P(66) is 0.1155 (=0.231 / 2) mm;

[0114] The abscissa (X) of the second pattern unit in the second section 220, i.e., the 67th pattern unit P(67), is 15.181 (=14.95 mm+0.231) mm, and the second axial pitch DN2(67) between the 67th pattern unit P(67) and the 68th pattern unit P(68) is:

[0115] DN2(67)=(2x10 -5 )15.181 2 -0.0005*15.181+0.234=0.23102,

[0116] Accordingly, the sub-pitch G(67) in the pattern unit P(67) is 0.11551 (=0.23102 / 2) mm;

[0117] ...And so on, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.

[0118] In addition, the second slot angle A2(i) of the second section 220 decreases in an arithmetic progression from the distal side to the proximal side with a tolerance of 0.037. Correspondingly, the second bridge angle B2(i) increases in an arithmetic progression from the distal side to the proximal side with the same tolerance of 0.037, wherein i is a natural number sequence, which is the ordinal number of the pattern unit arranged from the distal side to the proximal side among all pattern units.

[0119] Paragraph 3, 230:

[0120] The third section 230 has 507 repeated pattern units P, and the third axial pitch DN3 is 0.357 mm. It can be seen that the axial length of the third section 230 is 181 (=0.357*507) mm. Accordingly, the sub-pitch G1 in the pattern units in the third section 230 is 0.1785 mm.

[0121] In addition, the third slot angle A3 of the third section 230 is 135 degrees, and correspondingly, the third bridge angle B3 is 45 degrees.

[0122] It should be noted that the change in the slot angle A of the pattern unit P described above only occurs between the pattern units, not inside the pattern unit P. In other words, the slot angle A is the same inside the pattern unit. This is applicable to the following embodiments.

[0123] Preferably, a step portion 310 is provided at the nearest end of the proximal uncut segment 300, at a position for bonding with the core wire, and the step portion 310 can increase the bonding area with the internal core wire, thereby increasing the firmness of the bonding.

[0124] Preferably, two step portions are provided.

[0125] 2. Second implementation (NC2):

[0126] In this preferred embodiment, reference Figure 1 and Figure 3 The outer diameter OD of the hypotube 10 is 0.38 mm, and the total axial length M is about 573.6 mm, wherein the axial length of the proximal uncut section 300 is 0.69 mm, and the axial slot width sw of the slot S is 0.042 mm. The first offset angle α1 of the counterclockwise circumferential offset of the first pattern subunit PS1 and the second pattern subunit PS2 inside the pattern unit P is 80 degrees, and the second offset angle α2 of the clockwise circumferential offset of the pattern units from the distal side to the proximal side is about 25 degrees.

[0127] First paragraph 210:

[0128] The first section 210 has 89 repeated pattern units P, and the first axial pitch DN1 is 0.18 mm. Therefore, the axial length of the first section 210 is 16.02 (= 0.18 * 89) mm. Accordingly, the sub-pitch G1 in the pattern units in the first section 210 is 0.09 mm.

[0129] In addition, the first slot angle A1 of the first section 210 is 155 degrees, and correspondingly, the first bridge angle B1 is 25 degrees.

[0130] Paragraph 220:

[0131] The second segment 220 has 465 repeated pattern units P, and the second axial pitch DN2 varies according to the above formula 2:

[0132] DN2(i)=d*Ln(X)+e,

[0133] Among them, d = 0.083, e = -0.05,

[0134] Wherein, Ln(X) represents the natural logarithm of X with base e (Ln(e)=1);

[0135] For example, in this embodiment, the abscissa of the starting position of the second section 220 is 16.02 mm: that is, the abscissa (X) of the 90th pattern unit P(90) (the first pattern unit in the second section 220) is 16.02 (=89*0.18) mm, and the second axial pitch DN2(90) between the 90th pattern unit P(90) and the 91st pattern unit P(91) is:

[0136] DN2(90)=0.083*Ln(16.02)-0.05=0.18,

[0137] Accordingly, the sub-pitch G(90) in the pattern unit P(90) is 0.09 (=0.18 / 2) mm;

[0138] The abscissa (X) of the second pattern unit in the second section 220, i.e., the 91st pattern unit P(91), is 16.2 (=16.02+0.18) mm, and the second axial pitch DN2(91) between the 91st pattern unit P(91) and the 92nd pattern unit P(92) is:

[0139] DN2(91)=0.083*Ln(16.2)-0.05=0.181,

[0140] Accordingly, the sub-pitch G(91) in the pattern unit P(91) is 0.0905 (=0.181 / 2) mm;

[0141] ...And so on, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.

[0142] In addition, the second slot angle A2(i) of the second section 220 decreases in an arithmetic progression from the distal side to the proximal side with a tolerance of 0.0.127. Correspondingly, the second bridge angle B2(i) increases in an arithmetic progression from the distal side to the proximal side with the same tolerance of 0.127.

[0143] Paragraph 3, 230:

[0144] The third section 230 has 1137 repeated pattern units P, and the third axial pitch DN3 is 0.3682 mm. Therefore, the axial length of the third section 230 is 418.6 (= 0.3682 * 1137) mm. Accordingly, the sub-pitch G1 in the pattern units in the third section 230 is 0.1841 mm.

[0145] In addition, the third slot angle A3 of the third section 230 is 115 degrees, and correspondingly, the third bridge angle B3 is 65 degrees.

[0146] Preferably, a step portion 310 is provided at the nearest end of the proximal uncut segment 300, at a position for bonding with the core wire, and the step portion 310 can increase the bonding area with the internal core wire, thereby increasing the firmness of the bonding.

[0147] Preferably, two step portions are provided.

[0148] 3. Third implementation mode (NC10):

[0149] In this preferred embodiment, reference Figure 2 and Figure 3 The outer diameter OD of the hypotube 10 is 0.213 mm, and the total axial length M is about 559 mm, wherein the axial length of the proximal uncut section 300 is 0.62 mm, and the axial slot width sw of the slot S is 0.021 mm. The first offset angle α1 of the clockwise circumferential offset of the first pattern subunit PS1 and the second pattern subunit PS2 inside the pattern unit P is 85 degrees, and the second offset angle α2 of the clockwise circumferential offset of the pattern unit P from the distal side to the proximal side is about 18 degrees.

[0150] First paragraph 210:

[0151] The first section 210 has 95 repeated pattern units P, and the first axial pitch DN1 is 0.164 mm. Therefore, the axial length of the first section 210 is 15.58 (= 0.164 * 95) mm. Accordingly, the sub-pitch G1 in the pattern units in the first section 210 is 0.082 mm.

[0152] In addition, the first slot angle A1 of the first section 210 is 168 degrees, and correspondingly, the first bridge angle B1 is 12 degrees.

[0153] Paragraph 220:

[0154] The second segment 220 has 425 repeated pattern units P, and the second axial pitch DN2 varies according to the above formula 2:

[0155] DN2(i)=d*Ln(X)+e,

[0156] Among them, d = 0.058, e = 0.005,

[0157] Wherein, Ln(X) represents the natural logarithm of X with base e (Ln(e)=1);

[0158] For example, in this embodiment, the abscissa of the starting position of the second section 220 is 15.58 mm: that is, the abscissa (X) of the 96th pattern unit P(96) (the first pattern unit in the second section 220) is 15.58 (=95*0.164) mm, and the second axial pitch DN2(96) between the 96th pattern unit P(96) and the 97th pattern unit P(97) is:

[0159] DN2(96)=0.058*Ln(15.58)+0.005=0.1643,

[0160] Accordingly, the sub-pitch G(96) in the pattern unit P(96) is 0.082 (=0.1643 / 2) mm;

[0161] The abscissa (X) of the second pattern unit in the second section 220, i.e., the 97th pattern unit P(97), is 15.744 (=15.58+0.1643) mm, and the second axial pitch DN2(97) between the 97th pattern unit P(97) and the 98th pattern unit P(98) is:

[0162] DN2(97)=0.058*Ln(15.744)+0.005=0.1649,

[0163] Accordingly, the sub-pitch G(97) in the pattern unit P(97) is 0.0824 (=0.1649 / 2) mm;

[0164] ...And so on, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.

[0165] In addition, the second slot angle A2(i) of the second section 220 decreases in an arithmetic progression from the distal side to the proximal side with a tolerance of 0.054. Correspondingly, the second bridge angle B2(i) increases in an arithmetic progression from the distal side to the proximal side with the same tolerance of 0.054.

[0166] Paragraph 3, 230:

[0167] The third section 230 has 1574 repeated pattern units P, and the third axial pitch DN3 is 0.281 mm. Therefore, the axial length of the third section 230 is 442.3 (=0.281*1574) mm. Accordingly, the sub-pitch G1 in the pattern units in the third section 230 is 0.1405 mm.

[0168] In addition, the third slot angle A3 of the third section 230 is 145 degrees, and correspondingly, the third bridge angle B3 is 35 degrees.

[0169] 4. Fourth implementation method (NC12):

[0170] In this preferred embodiment, reference Figure 2 and Figure 3 The outer diameter OD of the hypotube 10 is 0.278 mm, the total axial length M is about 609 mm, the axial length of the proximal uncut section 300 is 0.71 mm, and the axial slot width sw of the slot S is 0.02 mm. The first offset angle α1 of the clockwise circumferential offset of the first pattern subunit PS1 and the second pattern subunit PS2 inside the pattern unit P is 110 degrees, and the second offset angle α2 of the clockwise circumferential offset of the pattern unit P from the distal side to the proximal side is about 22 degrees.

[0171] First paragraph 210:

[0172] The first section 210 has 98 repeated pattern units P, and the first axial pitch DN1 is 0.17 mm. Therefore, the axial length of the first section 210 is 16.66 (= 0.17 * 98) mm. Accordingly, the sub-pitch G1 in the pattern units in the first section 210 is 0.085 mm.

[0173] In addition, the first slot angle A1 of the first section 210 is 156 degrees, and correspondingly, the first bridge angle B1 is 24 degrees.

[0174] Paragraph 220:

[0175] The second segment 220 has 432 repeated pattern units P, and the second axial pitch DN2 varies according to the above formula 3:

[0176] DN2(i)=f*X+g;

[0177] Among them, f = 0.0018, g = 0.145,

[0178] For example, in this embodiment, the abscissa of the starting position of the second section 220 is 16.66 mm: that is, the abscissa (X) of the 99th pattern unit P(99) (the first pattern unit in the second section 220) is 16.66 (=98*0.17) mm, and the second axial pitch DN2(99) between the 99th pattern unit P(99) and the 100th pattern unit P(100) is:

[0179] DN2(99)=0.0018*(16.66)+0.145=0.175,

[0180] Accordingly, the sub-pitch G(99) in the pattern unit P(99) is 0.087 (=0.175 / 2) mm;

[0181] The abscissa (X) of the second pattern unit in the second section 220, i.e., the 100th pattern unit P(100), is 16.835 (=16.66+0.175) mm, and the second axial pitch DN2(100) between the 100th pattern unit P(100) and the 101st pattern unit P(101) is:

[0182] DN2(100)=0.0018*(16.835)+0.145=0.1753,

[0183] Accordingly, the sub-pitch G(100) in the pattern unit P(100) is 0.0877 (=0.1753 / 2) mm;

[0184] ...And so on, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.

[0185] In addition, the second slot angle A2(i) of the second section 220 decreases in an arithmetic progression from the distal side to the proximal side with a tolerance of 0.107. Correspondingly, the second bridge angle B2(i) increases in an arithmetic progression from the distal side to the proximal side with the same tolerance of 0.107.

[0186] Paragraph 3, 230:

[0187] The third section 230 has 1255 repeated pattern units P, and the third axial pitch DN3 is 0.38 mm. Therefore, the axial length of the third section 230 is 476.9 (=0.38*1255) mm. Accordingly, the sub-pitch G1 in the pattern units in the third section 230 is 0.19 mm.

[0188] In addition, the third slot angle A3 of the third section 230 is 110 degrees, and correspondingly, the third bridge angle B3 is 70 degrees.

[0189] In the above examples, although the number of pattern units in each part of the middle cutting section 200 has been specifically illustrated, this is not a limitation of the present invention. In fact, the number can be set according to actual needs or usage scenarios, through parameters such as axial length and axial pitch.

[0190] The above describes in detail the hypotube 10 according to different preferred embodiments of the present invention. As described above, the technical solution of the present invention limits the change of the axial pitch according to the axial position, which can make the axial pitch change in a smoother manner, thereby obtaining a smoother transition section.

[0191] Furthermore, the present invention innovatively adopts quadratic formulas, exponential formulas, etc. to limit the change of axial pitch, which further makes the transition section smoother, thereby allowing a more compliant distal section to be connected with a more supportive proximal section with a good transition section.

[0192] Refer to the following Figure 4 and Figure 5 , which shows a micro guidewire according to an embodiment of the present invention. The micro guidewire includes a guidewire 11, a torque controller and a guidewire needle, wherein the guidewire 11 includes a core wire 12, a winding wire 13 and a hypotube 10 as described above, and the hypotube 10 is arranged to surround the core wire 12 and the winding wire 13. The core wire 12 can generally be made of stainless steel or polytetrafluoroethylene (PTFE), and the winding wire 13 can generally be made of platinum-tungsten alloy.

[0193] Various embodiments of the present invention have been described above; however, the present invention is not limited thereto.

[0194] Beneficial technical effects:

[0195] The sea wave tube according to the present invention has a larger axial pitch in the section near the proximal end and a smaller axial pitch in the section near the distal end. The smaller the axial pitch, the easier it is for the sea wave tube to bend, thereby making the distal end of the sea wave tube softer, which greatly reduces the possibility of damaging the blood vessel, while its proximal end has better support to make the operation more stable.

[0196] At the same time, the sea wave tube according to the present invention optimizes the transition mode of the axial pitch DN so that it gradually increases from the distal side to the proximal side in a smoother manner, thereby achieving better flexibility and support.

[0197] However, different embodiments of the sea wave tube according to the present invention may focus on different technical effects. Specifically, the way in which the axial pitch DN changes can affect the performance of the sea wave tube. In other words, the impact on the performance of the sea wave tube is mainly reflected in the way in which DN changes in the transition section, that is, the second section of the middle cutting section. If the DN value of the middle cutting section is relatively large, such a sea wave tube can provide relatively better support performance. If the DN value of the middle cutting section is relatively small, such a sea wave tube can provide better flexibility. In addition, the way in which the slot angle A of the pattern unit P changes also appropriately affects the performance of the sea wave tube. The larger the slot angle A, the larger the proportion of the hollow part, so the radius curvature of the sea wave tube that can bend is smaller, allowing it to pass through more tortuous blood vessels.

[0198] According to the present invention, the sea wave tube has the largest slot angle A at the section near the distal end, which makes the distal end of the sea wave tube softer to facilitate passing through more tortuous blood vessels; while the section near the proximal end has the smallest slot angle A, thereby making the proximal end have better support.

[0199] In addition, the various embodiments of the sea wave tube 10 according to the present invention can be suitable for different application environments. For example, the size of the neural micro-guidewire commonly used in the market is 0.014 inches (0.3556 mm), which can reach the position of the middle cerebral artery M2, so a sea wave tube 10 with a relatively large outer diameter, i.e., the first and second embodiments (NC1 and NC2) mentioned above, can be used. However, for some more distant thrombi or lesions in the skull, or for some thinner or narrower blood vessels, a thinner micro-guidewire is required, and a sea wave tube 10 with a relatively small outer diameter, such as the third and fourth embodiments (NC10 and NC12) mentioned above, can be used.

[0200] Although some embodiments and variations of the present invention have been specifically described, it will be appreciated by those skilled in the art that the present invention is not limited to the embodiments and variations described above and shown in the accompanying drawings but may include other various possible combinations and combinations. Other variations and variations may be realized by those skilled in the art without departing from the spirit and scope of the present invention. All these variations and variations fall within the scope of the present invention. Moreover, all components described herein may be replaced by other technically equivalent components.

[0201] The embodiments of the present invention are not limited to the above embodiments. Without departing from the spirit and scope of the present invention, ordinary technicians in this field can make various changes and improvements to the present invention in form and details, and these are considered to fall within the protection scope of the present invention.

Claims

1. A hypotube (10), comprising, from the distal side to the proximal side in the axial direction, a distal uncut section (100), an intermediate cut section (200), and a proximal uncut section (300), wherein the intermediate cut section (200) is provided with a plurality of pattern units (P) formed by slots (S) along the axial direction, wherein the slots (S) have an axial slot width (SW) and a slot angle (A) corresponding to a circumferential length, and the difference between the axial positions (X) of two adjacent pattern units is defined as an axial pitch (DN), and the intermediate cut section (200) is divided into a first section (210), a second section (220), and a third section (230) along the axial direction from the distal side to the proximal side, wherein: The first segment has a constant first axial pitch (DN1), The second section has a second varying axial pitch (DN2), The third segment has a constant third axial pitch (DN3), and The first axial pitch (DN1) is smaller than the third axial pitch (DN3), and the second axial pitch (DN2) varies with its axial position, so that the second axial pitch (DN2) gradually increases from the first axial pitch (DN1) to the third axial pitch (DN3) along the axial direction, and in, The second axial pitch (DN2) is an exponential function of its axial position, namely: DN2=a*10 -5 *X 2 –b*X+c, Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch, And wherein a is between 1-9, b is between 0.0002-0.001, and c is between 0.1-0.

5.

2. The hypotube (10) according to claim 1, characterized in that: The pattern units in the first section are identical to each other, The pattern units of the second section regularly transition from the pattern units of the first section to the pattern units of the third section, The pattern units in the third section are identical to each other.

3. The hypotube (10) according to claim 2, characterized in that: The slots (S) at the same axial position form a pattern sub-unit, and the pattern unit (P) includes a plurality of pattern sub-units arranged at different axial positions, wherein the plurality of pattern sub-units of the pattern unit (P) are distributed at equal intervals along the axial direction.

4. The hypotube (10) according to claim 3, characterized in that: The pattern unit (P) includes two pattern sub-units, and the difference between the axial positions (X) of the two pattern sub-units is defined as a sub-pitch (G), and the sub-pitch (G) is half of the axial pitch (DN) between the pattern unit and the pattern unit on the adjacent side.

5. The hypotube (10) according to claim 3, characterized in that: The pattern sub-unit has a pattern arrangement formed by two or more identical slots (S) uniformly distributed circumferentially, and the plurality of pattern sub-units in the pattern unit have the same pattern arrangement but are sequentially circumferentially offset by a first offset angle (α1) in the same direction.

6. The hypotube (10) according to claim 2, characterized in that: The first slotting angle (A1) in the first section is greater than the third slotting angle (A3) in the third section, and the second slotting angle (A2) in the second section decreases from the first slotting angle (A1) to the third slotting angle (A3) in an arithmetic progression.

7. The hypotube (10) according to claim 5, characterized in that: The pattern units (P) are circumferentially offset by a second offset angle (α2) in sequence from the distal side to the proximal side.

8. The hypotube (10) according to claim 7, characterized in that: The second offset angle (α2) is oriented in the same direction as the first offset angle (α1).

9. The hypotube (10) according to claim 1, characterized in that: A step portion (310) is provided at the proximal side of the proximal uncut section (300).

10. The hypotube (10) according to claim 1, characterized in that: The number of the pattern units in the first section, the second section, and the third section of the middle cutting section (200) is determined according to the corresponding axial length and axial pitch.

11. A hypotube (10), comprising, from the distal side to the proximal side in the axial direction, a distal uncut section (100), an intermediate cut section (200), and a proximal uncut section (300), wherein the intermediate cut section (200) is provided with a plurality of pattern units (P) formed by slots (S) along the axial direction, wherein the slots (S) have an axial slot width (SW) and a slot angle (A) corresponding to a circumferential length, and the difference between the axial positions (X) of two adjacent pattern units is defined as an axial pitch (DN), and the intermediate cut section (200) is divided into a first section (210), a second section (220), and a third section (230) along the axial direction from the distal side to the proximal side, wherein: The first segment has a constant first axial pitch (DN1), The second section has a second varying axial pitch (DN2), The third segment has a constant third axial pitch (DN3), and The first axial pitch (DN1) is smaller than the third axial pitch (DN3), and the second axial pitch (DN2) varies with its axial position, so that the second axial pitch (DN2) gradually increases from the first axial pitch (DN1) to the third axial pitch (DN3) along the axial direction, and in, The second axial pitch (DN2) is a logarithmic function of its axial position, namely: DN2=d*Ln(X)+e, Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch, and wherein d is between 0.03 and 0.1, and e is between (-0.02) and (-0.08); or, d is between 0.03-0.1, and e is between 0.002~0.

015.

12. The hypotube (10) according to claim 11, characterized in that The pattern units in the first section are identical to each other, The pattern units of the second section regularly transition from the pattern units of the first section to the pattern units of the third section, The pattern units in the third section are identical to each other.

13. The hypotube (10) according to claim 12, characterized in that: The slots (S) at the same axial position form a pattern sub-unit, and the pattern unit (P) includes a plurality of pattern sub-units arranged at different axial positions, wherein the plurality of pattern sub-units of the pattern unit (P) are distributed at equal intervals along the axial direction.

14. The hypotube (10) according to claim 13, characterized in that: The pattern unit (P) includes two pattern sub-units, and the difference between the axial positions (X) of the two pattern sub-units is defined as a sub-pitch (G), and the sub-pitch (G) is half of the axial pitch (DN) between the pattern unit and the pattern unit on the adjacent side.

15. The hypotube (10) according to claim 13, characterized in that The pattern sub-unit has a pattern arrangement formed by two or more identical slots (S) uniformly distributed circumferentially, and the plurality of pattern sub-units in the pattern unit have the same pattern arrangement but are sequentially circumferentially offset by a first offset angle (α1) in the same direction.

16. The hypotube (10) according to claim 12, characterized in that: The first slotting angle (A1) in the first section is greater than the third slotting angle (A3) in the third section, and the second slotting angle (A2) in the second section decreases from the first slotting angle (A1) to the third slotting angle (A3) in an arithmetic progression.

17. The hypotube (10) according to claim 15, characterized in that The pattern units (P) are circumferentially offset by a second offset angle (α2) in sequence from the distal side to the proximal side.

18. The hypotube (10) according to claim 17, characterized in that The second offset angle (α2) is oriented in the same direction as the first offset angle (α1).

19. The hypotube (10) according to claim 11, characterized in that A step portion (310) is provided at the proximal side of the proximal uncut section (300).

20. The hypotube (10) according to claim 11, characterized in that The number of the pattern units in the first section, the second section, and the third section of the middle cutting section (200) is determined according to the corresponding axial length and axial pitch.

21. A hypotube (10), comprising a distal uncut section (100), an intermediate cut section (200), and a proximal uncut section (300) in order from the distal side to the proximal side in the axial direction, wherein the intermediate cut section (200) is provided with a plurality of pattern units (P) formed by slots (S) in the axial direction, wherein the slots (S) have an axial slot width (SW) and a slot angle (A) corresponding to a circumferential length, and the difference between the axial positions (X) of two adjacent pattern units is defined as an axial pitch (DN), and the intermediate cut section (200) is divided into a first section (210), a second section (220), and a third section (230) in order from the distal side to the proximal side in the axial direction, wherein: The first segment has a constant first axial pitch (DN1), The second section has a second varying axial pitch (DN2), The third segment has a constant third axial pitch (DN3), and The first axial pitch (DN1) is smaller than the third axial pitch (DN3), and the second axial pitch (DN2) varies with its axial position, so that the second axial pitch (DN2) gradually increases from the first axial pitch (DN1) to the third axial pitch (DN3) along the axial direction, and in, The second axial pitch (DN2) is a linear function of its axial position, namely: DN2= f*X+g; Wherein, X is the axial position of the pattern unit on the relatively far side involved in the second axial pitch, And wherein f is between 0.001 and 0.003, and g is between 0.1 and 0.

3.

22. The hypotube (10) according to claim 21, characterized in that The pattern units in the first section are identical to each other, The pattern units of the second section regularly transition from the pattern units of the first section to the pattern units of the third section, The pattern units in the third section are identical to each other.

23. The hypotube (10) according to claim 22, characterized in that The slots (S) at the same axial position form a pattern sub-unit, and the pattern unit (P) includes a plurality of pattern sub-units arranged at different axial positions, wherein the plurality of pattern sub-units of the pattern unit (P) are distributed at equal intervals along the axial direction.

24. The hypotube (10) according to claim 23, characterized in that The pattern unit (P) includes two pattern sub-units, and the difference between the axial positions (X) of the two pattern sub-units is defined as a sub-pitch (G), and the sub-pitch (G) is half of the axial pitch (DN) between the pattern unit and the pattern unit on the adjacent side.

25. The hypotube (10) according to claim 23, characterized in that The pattern sub-unit has a pattern arrangement formed by two or more identical slots (S) uniformly distributed circumferentially, and the plurality of pattern sub-units in the pattern unit have the same pattern arrangement but are sequentially circumferentially offset by a first offset angle (α1) in the same direction.

26. The hypotube (10) according to claim 22, characterized in that The first slotting angle (A1) in the first section is greater than the third slotting angle (A3) in the third section, and the second slotting angle (A2) in the second section decreases from the first slotting angle (A1) to the third slotting angle (A3) in an arithmetic progression.

27. The hypotube (10) according to claim 25, characterized in that The pattern units (P) are circumferentially offset by a second offset angle (α2) in sequence from the distal side to the proximal side.

28. The hypotube (10) according to claim 27, characterized in that The second offset angle (α2) is oriented in the same direction as the first offset angle (α1).

29. The hypotube (10) according to claim 21, characterized in that A step portion (310) is provided at the proximal side of the proximal uncut section (300).

30. The hypotube (10) according to claim 21, characterized in that The number of the pattern units in the first section, the second section, and the third section of the middle cutting section (200) is determined according to the corresponding axial length and axial pitch.

31. A micro guidewire, comprising a hypotube according to any one of claims 1 to 30, wherein the hypotube surrounds a core wire and a winding wire of the micro guidewire.

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