Detailed Description
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.
The term "comprising" or variations thereof, such as "comprising," "having," "including," means including the stated step or element, but not excluding any other step or element.
When referring to a numerical range, it is intended that the upper and lower limits of the range be specifically disclosed, as well as all intervening ranges encompassed therein, for example, intermediate ranges between the upper or lower limit and any intermediate value or between any two intermediate values thereof. Also, any intervening ranges, subranges, and any individual value described in that numerical range may be excluded from the numerical range.
The term "and/or" as used herein is understood to mean any one or combination of any of a plurality of elements connected by the term.
The technical features of the different embodiments to be described below may be combined in any manner, and for brevity of description, all of these possible combinations are not described, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
Herein, when referring to "proximal" or "proximal", it generally refers to an end or side near the operator, or may also be referred to as an operative end or side, and when referring to "distal" or "distal", it generally refers to an end or side remote from the operator, in other words, an end or side accessible to the patient's body, or may also be referred to as an access end or side. In the drawings of the present application, unless specifically stated otherwise, the "left" of the view is the direction toward the "distal" or "distal" described above, and the "right" of the view is the direction toward the "proximal" or "proximal" described above.
Other features and advantages of the present invention will become apparent upon review of the detailed description of the invention in conjunction with the drawings.
Basic structure and dimensions of hypotubes:
First, the general structure of the hypotube will be described with reference to the accompanying drawings.
In this specification, hypotubes are generally referred to by the reference numeral 10. Hypotubes 10 are typically made of nickel titanium alloy (NiTi) (GB 24627-2009/ASTM F2063-05) and may be made as thin walled tubular bodies of different gauges (outer diameter/wall thickness) to accommodate guidewires for use in different use environments.
Preferably, the hypotube may have an outer diameter between about 0.1239mm and 0.4343 mm.
Generally, referring to fig. 1 and 2, hypotube 10 includes, in order from distal to proximal in axial direction L, a distal uncut segment 100, an intermediate cut segment 200, and a proximal uncut segment 300. The distal uncut segment 100 is used to attach a balloon or other surgical tool for performing a corresponding surgical procedure, and the proximal uncut segment 300 is used for operator application of force. The length of both the distal uncut segment 100 and the proximal uncut segment 300 are relatively small, with the intermediate cut segment 200 occupying a substantial portion of the overall length of the hypotube 10.
As shown, the intermediate cutting section 200 is provided with a number of slots S, each extending generally in a circumferential direction and being arranged at a plurality of axial positions. Due to the presence of these slots S, the hypotube 10 is provided with both a corresponding compliance and sufficient support to effectively transfer the pushing force of the proximal end to the distal end. These slots S may be cut in sequence by machining means such as laser cutting or the like.
Herein, for convenience of description, a reference coordinate system will be defined, wherein a distal start point of the intermediate cutting segment 200 is defined as an origin of the reference coordinate system, an axial direction L is defined as an abscissa axis, and an expanded circumferential direction is defined as an ordinate axis. Thus, the axial distance of any point on the intermediate cutting segment 200 from this distal starting point of the intermediate cutting segment 200 may be understood as the abscissa X of this point in the reference coordinate system, also referred to as the axial position X of this point on the intermediate cutting segment 200, or simply the axial position X of this point.
Referring to fig. 3, the slot S is mainly characterized by (1) a slot width sw in its axial direction, and (2) an angle a corresponding to a length in its circumferential direction. At the same time, the circumferential distribution of the individual slots at the same axial position, together with the slot width sw and the angle a of the slots, define a pattern arrangement.
Preferably, the axial slot width sw of the slot S may be between about 0.01mm to 0.05 mm.
Preferably, all slots S on the intermediate cutting section 200 have the same axial slot width sw.
It will be appreciated that the slots S on the intermediate cutting segment 200 may also have different axial slot widths sw, e.g., it may be designed that the axial slot widths sw of the slots S are larger nearer the distal end and smaller nearer the proximal end.
Preferably, at the same axial position on the intermediate cutting section 200, the same 2 slots uniformly distributed in the circumferential direction, i.e. 2 slots having the same slot width sw and the same angle a, may be arranged.
It will be appreciated that other arrangements are possible. For example, at the same axial position on the intermediate cutting section 200, the same 3 or more slots may be arranged uniformly distributed in the circumferential direction, or at the same axial position on the intermediate cutting section 200, only 1 slot is arranged, in which case the positions in the circumferential direction of two slots at adjacent two axial positions are substantially opposite.
This pattern arrangement in which the same 2 slots are arranged at the same axial position uniformly distributed in the circumferential direction will be described below as an example. It will be appreciated that at the same axial position there are also the same 2 ungrooved portions, hereinafter called bridge U, uniformly distributed in the circumferential direction.
In this example, the axial position (X) thereof is defined by the distal starting point of the slot S, and the plurality of axial positions at which the slot is arranged are defined, from distal to proximal, as first, second, third, fourth.
Still further, the pattern arrangement at each axial position may be defined as a pattern subunit PS, wherein the pattern arrangement at the first axial position is repeated at the second axial position but circumferentially offset by the first offset angle α1 in a clockwise (or counter-clockwise) direction, the pattern arrangement at the third axial position may have a different pattern arrangement than at the first axial position, and likewise the pattern arrangement at the third axial position is repeated at the fourth axial position but circumferentially offset by the first offset angle α1 in a clockwise (or counter-clockwise) direction. Thus, the pattern sub-units at the first and second axial positions together form a pattern unit P, the pattern sub-units at the third and fourth axial positions together form a pattern unit P.
Preferably, the first offset angle α1 may be between 60 and 120 degrees.
In the above example, each pattern unit P includes 2 pattern sub-units having the same pattern arrangement. It will be appreciated that each pattern unit P may also comprise other numbers of pattern sub-units, for example only one pattern sub-unit, or 3 or more pattern sub-units. The first offset angle α1 between pattern subunits in different pattern units P may also be different.
Here, the axial position or circumferential position of each pattern unit is defined with the slot S in the opposite distal side (closer to the origin of the reference coordinate system) of the pattern unit, while the difference between the axial positions of the adjacent two pattern units P (i.e., the difference between the abscissas in the reference coordinate system) is defined as the axial pitch DN, and the difference between the axial positions of the adjacent two pattern subunits PS in each pattern unit (i.e., the difference between the abscissas in the reference coordinate system) is defined as the sub-pitch G.
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 in the axial direction.
The intermediate cutting segment 200 may be divided into a first segment 210, a second segment 220, and a third segment 230 in sequence from distal to proximal in the axial direction L.
Preferably, the first segment 210 has a constant first axial pitch DN1, the second segment 220 has a varying second axial pitch DN2, and the third segment 230 has a constant third axial pitch DN3. Thus, the second section 220 may also be understood as a transition between the first section 210 and the third section 230.
Preferably, the first axial pitch DN1 may be between about 0.1mm to 0.3 mm.
Preferably, the third axial pitch DN3 may be between about 0.2mm to 0.6 mm.
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 such that the second axial pitch DN2 gradually increases from the first axial pitch DN1 to the third axial pitch DN3 in a smooth manner, distally to proximally.
In this context, when referring to a gradual increase from the first axial pitch DN1 to the third axial pitch DN3, it does not mean that the second axial pitch DN2 increases gradually from a value exactly equal to the first axial pitch DN1 to a value exactly equal to the third axial pitch DN3, but it is understood that the second axial pitch DN2 increases gradually from a value closer to the first axial pitch DN1 to a value closer to the third axial pitch DN 3.
Preferably, the second axial pitch DN2 may be an exponential function of its axial position, namely:
DN2=a.10-5*X2 -b.X+c, - - - - - - - - - - - - -, formula 1
Wherein X is the axial position of the relatively distal pattern unit relative to 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.
Preferably, the second axial pitch DN2 may be a logarithmic function of its axial position, namely:
DN 2=d Ln (X) +e, —— equation 2
Wherein X is an axial position of the pattern unit on the opposite distal side with respect to 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.
Preferably, the second axial pitch DN2 may be a linear function of its axial position, i.e.:
DN2=fX+g- - - - - - - - - - - - - - - - - - - - -, formula 3
Wherein X is the axial position of the pattern unit on the opposite distal side with respect to the second axial pitch, and more preferably, f is between 0.001 and 0.003, and g is between 0.1 and 0.3.
Preferably, the number of corresponding pattern units in the first section 210, the second section 220, and the third section 230 of the intermediate cutting section 200 may be determined according to a desired axial length and a preset axial pitch.
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 the pattern units of the first section to the pattern units of the third section, and the pattern units of the third section 230 are identical to each other.
It is understood that all of the pattern units in the first section 210 may not be identical, or all of the pattern units in the third section 230 may not be identical.
Preferably, the sub-pitch G in each pattern unit P is one half of the axial pitch DN between that pattern unit and its adjacent, proximal pattern unit.
Further, an angle corresponding to the circumferential length of the slot S in each pattern unit is defined as a slot angle a, and an angle corresponding to the circumferential length of the bridge portion U is defined as a bridge portion angle B. It will be appreciated that in this example, the following equation exists:
A+B=180°。
Preferably, the first segment 210 has a constant first slotting angle A1, the second segment 220 has a varying second slotting angle A2, and the third segment 230 has a constant third slotting angle A3, and correspondingly, the first segment 210 has a constant first bridge angle B1, the second segment 220 has a varying second bridge angle B2, and the third segment 230 has a constant third bridge angle B3.
Preferably, the first slotting angle A1 is greater than the third slotting angle A3, the second slotting angle A2 decreasing in an arithmetic progression from distal to proximal, thereby transitioning from the first slotting angle A1 to the third slotting angle A3, and correspondingly, the first bridge angle B1 is less than the third bridge angle B3, and the second bridge angle B2 increasing in an arithmetic progression from distal to proximal, thereby transitioning from the first bridge angle B1 to the third bridge angle B3.
Preferably, the first grooving angle A1 in the first section 210 may be between 140 degrees and 170 degrees.
Preferably, the second slot angle A2 in the second section 220 may be decreased by an arithmetic progression having a tolerance of 0.03-0.3.
Preferably, the third grooving angle A3 in the third section 230 may be between 100 and 150 degrees.
Preferably, the pattern units in the axial direction are sequentially circumferentially offset from distal to proximal by the second offset angle α2.
Preferably, the second offset angle α2 may be between 10 and 30 degrees.
Preferably, the second offset angle α2 may be oriented in the same direction as the first offset angle α1, i.e., if the pattern subunits are offset in a clockwise direction in sequence from distal to proximal, the pattern subunits are also offset in a clockwise direction in sequence from distal to proximal, and vice versa.
Preferably, the axial length of the proximal uncut segment 300 may be about 0.4mm to 0.8mm, and a stepped portion 310 is provided at the proximal side of the proximal uncut segment 300, and as shown in fig. 1, the stepped portion 310 may be sized to fit the size of the proximal uncut segment 300.
In the above, although a range of values of the relevant parameters is given, it will be understood by those skilled in the art that this does not mean that the respective parameters can be arbitrarily valued within their respective ranges, and in fact that the values of the respective parameters are interrelated, i.e. the values must be premised on the implementation of the technical solution defined by the present application, for example, the values of the coefficients in the above formulas 1 to 3 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, except within their respective ranges and meeting the practical application requirements.
Preferred embodiments of the present invention will be described in further detail below by way of examples. It is to be understood that although specific dimensions are set forth in the examples below, different dimensions in different examples may be combined according to actual needs or use situations, and such combinations should be considered not to exceed the scope of the present disclosure.
1. First embodiment (NC 1):
In the preferred embodiment, referring to fig. 1 and 3, the hypotube 10 has an outer diameter OD of 0.312mm and an overall axial length of about 274mm, wherein the proximal uncut segment 300 has an axial length of about 0.68mm and the slots S each have an axial slot width sw of 0.036mm. The first offset angle α1 of the first pattern subunit PS1 and the second pattern subunit PS2 within the pattern unit P circumferentially offset in the clockwise direction is 75 degrees, and the second offset angle α2 of the pattern units circumferentially offset in sequence from the distal side to the proximal side is about 20 degrees.
First section 210:
the first segment 210 has 65 repeating pattern units P, the first axial pitch DN1 is 0.23mm, and thus it is known that the axial length of the first segment 210 is 14.95 (=0.23×65) mm, and accordingly, the sub-pitch G1 in the pattern units in the first segment 210 is 0.115mm;
In addition, the first slot angles A1 of the first segments 210 are all 150 degrees, and correspondingly, the first bridge angles B1 are all 30 degrees.
The second section 220:
the second segment 220 has 286 repeating pattern units P, and the second axial pitch DN2 varies according to equation 1 above:
DN2(i)=a*10-5*X2-b*X+c,
Where a=2, b=0.0005, c=0.234,
Where i is a natural number sequence, which is the ordinal number of the relatively far side (nearer to the origin of the reference coordinate system) pattern unit involved in the second axial pitch, which is arranged from far side to near side in all pattern units, and X is the abscissa (X) of the relatively far side (nearer to the origin of the reference coordinate system) pattern unit P (i), which is still used for other embodiments.
For example, in this embodiment, the abscissa of the start position of the second segment 220 is 14.95mm, that is, the abscissa (X) of the 66 th pattern unit P (66) (1 st pattern unit in the second segment 220) is 14.95 (=65×0.23) mm, and the second axial pitch DN2 (66) between the 66 th pattern unit P (66) and the 67 th pattern unit P (67) is:
DN2(66)=(2x10-5)14.952 -0.0005*14.95+0.234=0.231,
Accordingly, the sub-pitch G (66) in the pattern unit P (66) is 0.1155 (=0.231/2) mm;
The 2 nd pattern unit in the second segment 220, i.e. 67 th pattern unit P (67), has an abscissa (X) of 15.181 (=14.95 mm+0.231) mm, and the second axial pitch DN2 (67) between the 67 th pattern unit P (67) and 68 th pattern unit P (68) is:
DN2(67)=(2x10-5)15.1812 -0.0005*15.181+0.234=0.23102,
Accordingly, the sub-pitch G (67) in the pattern unit P (67) is 0.11551 (= 0.23102/2) mm;
... With this, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.
In addition, the second slot angle A2 (i) of the second segment 220 decreases in an arithmetic progression from distal to proximal with a tolerance of 0.037, and correspondingly, the second bridge angle B2 (i) increases in an arithmetic progression from distal to proximal with the same tolerance of 0.037, where i is a natural number sequence, which is the number of sequential arrangements of the pattern elements from distal to proximal in all pattern elements.
Third section 230:
the third segment 230 has 507 repeated pattern units P, and the third axial pitch DN3 is 0.357mm, so that it is known that the axial length of the third segment 230 is 181 (=0.357×507) mm, and accordingly, the sub-pitch G1 in the pattern units in the third segment 230 is 0.1785mm.
In addition, the third slot angles A3 of the third segments 230 are 135 degrees, and correspondingly, the third bridge angles B3 are 45 degrees.
It should be noted that the change of the grooving angle a of the pattern unit P described above occurs only between pattern units, not inside the pattern unit P. In other words, the grooving angle a is the same for the inside of the pattern unit. This applies to the following embodiments.
Preferably, a step 310 is provided at a position for bonding with the core wire at the nearest end of the proximal uncut segment 300, and the step 310 may increase the bonding area with the inner core wire, thereby increasing the bonding firmness.
Preferably, two stepped portions are provided.
2. Second embodiment (NC 2):
In the preferred embodiment, referring to fig. 1 and 3, the hypotube 10 has an outer diameter OD of 0.38mm and an overall axial length M of about 573.6mm, wherein the proximal uncut segment 300 has an axial length of 0.69mm and the slots S have an axial slot width sw of 0.042mm. The first offset angle α1 of the first pattern subunit PS1 and the second pattern subunit PS2 in the pattern unit P circumferentially offset in the counterclockwise direction is 80 degrees, and the second offset angle α2 of the pattern units circumferentially offset in the clockwise direction sequentially from the distal side to the proximal side is about 25 degrees.
First section 210:
The first segment 210 has 89 repeating pattern units P, the first axial pitch DN1 is 0.18mm, and thus it is known that the axial length of the first segment 210 is 16.02 (=0.18×89) mm, and accordingly, the sub-pitch G1 in the pattern units in the first segment 210 is 0.09mm;
In addition, the first slot angles A1 of the first segments 210 are 155 degrees, and correspondingly, the first bridge angles B1 are 25 degrees.
The second section 220:
the second segment 220 has 465 repeating pattern units P, and the second axial pitch DN2 varies according to equation 2 above:
DN2(i)=d*Ln(X)+e,
Wherein d=0.083, e= -0.05,
Wherein Ln (X) represents the natural logarithm of X with e as the base (Ln (e) =1);
For example, in this embodiment, the abscissa of the start position of the second segment 220 is 16.02mm, that is, the abscissa (X) of the 90 th pattern unit P (90) (1 st pattern unit in the second segment 220) is 16.02 (=89×0.18) mm, and the second axial pitch DN2 (90) between the 90 th pattern unit P (90) and the 91 st pattern unit P (91) is:
DN2(90)=0.083*Ln(16.02)-0.05=0.18,
accordingly, the sub-pitch G (90) in the pattern unit P (90) is 0.09 (=0.18/2) mm;
The 2 nd pattern unit in the second segment 220, i.e., the 91 st pattern unit P (91), has an abscissa (X) of 16.2 (=16.02+0.18) mm, and the second axial pitch DN2 (91) between the 91 st pattern unit P (91) and the 92 th pattern unit P (92) is:
DN2(91)=0.083*Ln(16.2)-0.05=0.181,
accordingly, the sub-pitch G (91) in the pattern unit P (91) is 0.0905 (=0.181/2) mm;
... With this, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.
In addition, the second slot angle A2 (i) of the second segment 220 decreases in an arithmetic progression from distal to proximal with a tolerance of 0.0.127, and correspondingly, the second bridge angle B2 (i) increases in an arithmetic progression from distal to proximal with the same tolerance of 0.127.
Third section 230:
The third segment 230 has 1137 repeating pattern units P, and the third axial pitch DN3 is 0.3682mm, so that the axial length of the third segment 230 is 418.6 (=0.3682×1137) mm, and accordingly, the sub-pitch G1 in the pattern units in the third segment 230 is 0.1841mm;
In addition, the third slot angles A3 of the third segments 230 are all 115 degrees, and correspondingly, the third bridge angles B3 are all 65 degrees.
Preferably, a step 310 is provided at a position for bonding with the core wire at the nearest end of the proximal uncut segment 300, and the step 310 may increase the bonding area with the inner core wire, thereby increasing the bonding firmness.
Preferably, two stepped portions are provided.
3. Third embodiment (NC 10):
In the preferred embodiment, referring to fig. 2 and 3, the hypotube 10 has an outer diameter OD of 0.213mm and an overall axial length M of about 559mm, wherein the proximal uncut segment 300 has an axial length of 0.62mm and the slots S have an axial slot width sw of 0.021mm. The first offset angle α1 of the first pattern subunit PS1 and the second pattern subunit PS2 within the pattern unit P circumferentially offset in the clockwise direction is 85 degrees, and the second offset angle α2 of the pattern unit P circumferentially offset in sequence from the distal side to the proximal side is about 18 degrees.
First section 210:
The first segment 210 has 95 repeating pattern units P, the first axial pitch DN1 is 0.164mm, and thus it is known that the axial length of the first segment 210 is 15.58 (=0.164×95) mm, and accordingly, the sub-pitch G1 in the pattern units in the first segment 210 is 0.082mm;
In addition, the first slot angles A1 of the first segments 210 are 168 degrees, and correspondingly, the first bridge angles B1 are 12 degrees.
The second section 220:
the second segment 220 has 425 repeating pattern units P, and the second axial pitch DN2 varies according to equation 2 above:
DN2(i)=d*Ln(X)+e,
Wherein d=0.058, e=0.005,
Wherein Ln (X) represents the natural logarithm of X with e as the base (Ln (e) =1);
For example, in this embodiment, the starting position of the second segment 220 has an abscissa of 15.58mm, that is, the 96 th pattern unit P (96) (1 st pattern unit in the second segment 220) has an abscissa (X) of 15.58 (=95×0.164) mm, and the second axial pitch DN2 (96) between the 96 th pattern unit P (96) and the 97 th pattern unit P (97) is:
DN2(96)=0.058*Ln(15.58)+0.005=0.1643,
Accordingly, the sub-pitch G (96) in the pattern unit P (96) is 0.082 (=0.1643/2) mm;
The 2 nd pattern unit in the second segment 220, i.e. the 97 th pattern unit P (97), has an abscissa (X) of 15.744 (=15.58+0.1643) mm, and the second axial pitch DN2 (97) between the 97 th pattern unit P (97) and the 98 th pattern unit P (98) is:
DN2(97)=0.058*Ln(15.744)+0.005=0.1649,
Accordingly, the sub-pitch G (97) in the pattern unit P (97) is 0.0824 (= 0.1649/2) mm;
... With this, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.
Furthermore, the second grooving angle A2 (i) of the second section 220 decreases in an arithmetic progression from distal to proximal with a tolerance of 0.054, and correspondingly, the second bridge angle B2 (i) increases in an arithmetic progression from distal to proximal with the same tolerance of 0.054.
Third section 230:
the third segment 230 has 1574 repeating pattern units P, the third axial pitch DN3 is 0.281mm, whereby it is known that the axial length of the third segment 230 is 442.3 (=0.281×1574) mm, and accordingly, the sub-pitch G1 in the pattern units in the third segment 230 is 0.1405mm;
in addition, the third slot angles A3 of the third segments 230 are 145 degrees, and correspondingly, the third bridge angles B3 are 35 degrees.
4. Fourth embodiment (NC 12):
In the preferred embodiment, referring to fig. 2 and 3, the hypotube 10 has an outer diameter OD of 0.278mm and an overall axial length M of approximately 609mm, wherein the proximal uncut segment 300 has an axial length of 0.71mm and the slots S have an axial slot width sw of 0.02mm. The first offset angle α1 of the first pattern subunit PS1 and the second pattern subunit PS2 in the pattern unit P circumferentially offset in the clockwise direction is 110 degrees, and the second offset angle α2 of the pattern unit P circumferentially offset in the clockwise direction sequentially from the distal side to the proximal side is about 22 degrees.
First section 210:
The first segment 210 has 98 repeated pattern units P, the first axial pitch DN1 is 0.17mm, and thus it is known that the axial length of the first segment 210 is 16.66 (=0.17×98) mm, and accordingly, the sub-pitch G1 in the pattern units in the first segment 210 is 0.085mm;
in addition, the first slot angles A1 of the first segments 210 are 156 degrees, and correspondingly, the first bridge angles B1 are 24 degrees.
The second section 220:
The second segment 220 has 432 repeating pattern units P, and the second axial pitch DN2 varies according to equation 3 above:
DN2(i)=f*X+g;
where f=0.0018, g=0.145,
For example, in this embodiment, the abscissa of the start position of the second segment 220 is 16.66mm, that is, the abscissa (X) of the 99 th pattern unit P (99) (1 st pattern unit in the second segment 220) is 16.66 (=98×0.17) mm, and the second axial pitch DN2 (99) between the 99 th pattern unit P (99) and the 100 th pattern unit P (100) is:
DN2(99)=0.0018*(16.66)+0.145=0.175,
accordingly, the sub-pitch G (99) in the pattern unit P (99) is 0.087 (=0.175/2) mm;
The 2 nd pattern unit in the second segment 220, i.e. the 100 th pattern unit P (100), has an abscissa (X) of 16.835 (=16.66+0.175) mm, and the second axial pitch DN2 (100) between the 100 th pattern unit P (100) and the 101 th pattern unit P (101) is:
DN2(100)=0.0018*(16.835)+0.145=0.1753,
Accordingly, the sub-pitch G (100) in the pattern unit P (100) is 0.0877 (= 0.1753/2) mm;
... With this, the second axial pitch DN2 in the second segment 220 and the sub-pitch G of the corresponding pattern unit P can be calculated.
Furthermore, the second grooving angle A2 (i) of the second section 220 decreases in an arithmetic progression from distal to proximal with a tolerance of 0.107, and correspondingly, the second bridge angle B2 (i) increases in an arithmetic progression from distal to proximal with the same tolerance of 0.107.
Third section 230:
The third segment 230 has 1255 repeating pattern units P, and the third axial pitch DN3 is 0.38mm, so that it is known that the axial length of the third segment 230 is 476.9 (=0.38×1255) mm, and accordingly, the sub-pitch G1 in the pattern units in the third segment 230 is 0.19mm;
in addition, the third slot angles A3 of the third segments 230 are all 110 degrees, and correspondingly, the third bridge angles B3 are all 70 degrees.
In the above examples, although the number of pattern units in each portion of the intermediate cutting section 200 has been specifically exemplified, this is not a limitation of the present invention. In practice, this number can be set according to the actual needs or use scenario, by parameters such as axial length, axial pitch, etc.
The hypotube 10 according to various preferred embodiments of the present invention is described in detail above. As described above, the technical solution of the present invention defines the variation of the axial pitch according to the axial position, which can be made to vary in a smoother manner, thereby obtaining a smoother transition section.
Still further, the present invention innovatively employs a quadratic equation, exponential equation, etc. to define the change in axial pitch, which also further smoothes the transition segment, allowing a more compliant distal segment to be connected with a more supportive proximal segment with a good transition segment.
Referring now to fig. 4 and 5, a microcatheter according to one embodiment of the present invention is shown. The micro-wire comprises a guide wire 11, a torsion controller and a harness cord, wherein the guide wire 11 comprises a core wire 12, a wire winding 13 and a hypotube 10 as described above, the hypotube 10 being arranged around the core wire 12 and the wire winding 13. The core wire 12 may be generally made of stainless steel or Polytetrafluoroethylene (PTFE) and the wire wrap 13 may be generally made of platinum tungsten alloy.
Various embodiments of the present invention are described above, however, the present invention is not limited thereto.
The beneficial technical effects are as follows:
The hypotube according to the present invention has a larger axial pitch in the proximal section and a smaller axial pitch in the distal section, the smaller the axial pitch, the more flexible the hypotube and thus the softer the distal end of the hypotube, which greatly reduces the likelihood of damaging the vessel while its proximal end has better support to make the procedure more stable.
Meanwhile, the hypotube according to the invention is gradually increased from far side to near side in a smoother manner by optimally designing the transition mode of the axial pitch DN, so that better flexibility and support can be achieved.
However, different embodiments of the hypotube according to the present invention may focus on different technical effects. In particular, the way in which the axial pitch DN varies can affect the performance of the hypotube, in other words, the effect on the hypotube performance is mainly reflected in the way in which DN varies in the transition section, i.e., the second section of the intermediate cutting section. Such a hypotube may provide relatively better support performance if the DN value of the middle cut is relatively large, and may provide better compliance if the DN value of the middle cut is relatively small. In addition, the manner of variation of the slotting angle a of the pattern element P also affects the performance of the hypotube appropriately. The larger the slotting angle A is, the larger the ratio of the hollowed part is, so that the smaller the radius curvature of the hypotube which can be bent is, and the hypotube can pass through a more tortuous blood vessel.
The hypotube according to the present invention has a maximum slotting angle a at the section near the distal end, which makes the distal end of the hypotube more flexible for passing more tortuous vessels, while its section near the proximal end has a minimum slotting angle a, which makes its proximal end have better support.
Furthermore, various embodiments of the hypotube 10 according to the present invention may be adapted for different application environments. For example, the nerve micro-guide wire currently in common use on the market has a size of 0.014 inches (0.3556 mm) which can reach the position of the middle cerebral artery M2, so that the hypotube 10 of the first and second embodiments (NC 1 and NC 2) described above, which has a relatively large outer diameter, can be used. However, for some more distant thrombi or lesions within the cranium, or for some relatively thin or narrow vessels, a thinner micro-wire is required, in which case hypotubes 10 of relatively small outer diameter, such as the third and fourth embodiments (NC 10 and NC 12) described above, may be used.
While some embodiments and variations of the present invention have been specifically described, it will be understood by those skilled in the art that the present invention is not limited to the embodiments and variations described above and shown in the drawings, but may include other various possible combinations and combinations. Other modifications and variations can be effected by those skilled in the art without departing from the spirit and scope of the invention. All such modifications and variations are intended to be within the scope of the present invention. Moreover, all the components described herein may be replaced by other technically equivalent elements.
The embodiments of the present invention are not limited to the above-described embodiments, and those skilled in the art can make various changes and modifications in form and detail without departing from the spirit and scope of the present invention, which are considered to fall within the scope of the present invention.