Microfabricated medical devices with non-spiral cut arrays

Abstract

The present disclosure relates to interventional devices, such as catheters and guidewire devices, with micromachined features to provide flexibility while maintaining good torqueability. The interventional device includes an elongated member (500) having an array of perforations defining multiple axially extending beams connecting multiple circumferentially extending rings. The perforations are arranged such that the resulting beams form a non-helical and non-linear pattern distributed along the length of the elongated member. The perforation pattern thereby minimizes or eliminates preferred bending axes. [Selection diagram] Figure 5

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 511,605, entitled "Micro-Fabricated Medical Device having a Distributed Cut Arrangement," filed May 26, 2017, and U.S. Provisional Patent Application No. 62 / 595,425, entitled "Micro-Fabricated Medical Device having a Non-Helical Cut Arrangement," filed December 6, 2017. All of the above applications are incorporated herein by reference in their entirety. [Background technology]

[0002]

[0002] Interventional devices such as guidewires and catheters are often utilized in the medical field to perform delicate procedures deep within the human body. Typically, a catheter is inserted into a patient's femoral, radial, carotid, or jugular vessels and navigated through the patient's vascular system to the heart, brain, or other target anatomical structure as needed. Often, a guidewire is first advanced to the target anatomical structure, and then one or more catheters are threaded over the guidewire and advanced to the target anatomical structure. Once positioned, the catheter can be used to deliver drugs, stents, embolic devices, radiopaque dyes, or other devices or substances to treat the patient in a desired manner.

[0003] In many applications, such interventional devices must bend through the tortuous bends and curves of vascular pathways to reach target anatomical structures. For example, navigating a guidewire and / or catheter to a portion of the neurovasculature requires passage through the internal carotid artery and other tortuous pathways. Such interventional devices require sufficient flexibility, particularly nearer their distal end, to navigate such tortuous pathways. However, other design aspects must also be considered. For example, the interventional device must also be able to provide sufficient torque capability (i.e., the ability to transmit torque applied at the proximal end all the way to the distal end), push capability (i.e., the ability to transmit axial pushing forces to the distal end but not through bent and convoluted intermediate sections), and structural integrity to perform its intended medical function.

[0004] With regard to torque capability, as greater lengths of interventional devices (such as guidewires) are passed into and through vasculature passageways, the amount of frictional surface contact between the guidewire and vasculature tissue increases, preventing easy movement through the vasculature passageway. The transmission of torque forces from the proximal to distal end allows the guidewire to rotate and overcome the frictional forces, thereby enabling further advancement and deployment. Summary of the Invention [Means for solving the problem]

[0005] The present disclosure relates to interventional devices (e.g., guidewires and catheters) having microfabricated features to provide flexibility while maintaining good torqueability. In one embodiment, the interventional device includes an elongated member having a wall and an internal lumen. The elongated member includes a plurality of perforations defining a plurality of axially extending beams and a plurality of circumferentially extending rings. The beams are arranged along the length of the elongated member to form a non-helical and non-linear pattern that functions to optimally distribute bending axes, thereby beneficially minimizing or eliminating preferred bending directions of the elongated member.

[0006] Some interventional devices include cuts / perforations intended to increase flexibility in certain sections of the interventional device. However, typical guidewire and catheter devices containing these features will have one or more preferred bending directions as a result of the structural arrangement and spacing of the perforations. While potentially useful in some applications, the preferred bending direction often has a detrimental effect on the device's navigation capabilities. For example, in some situations where an operator is attempting to reach a target anatomical region, the preferred bending direction tends to cause the device to "snap" toward the preferred bending direction. If the preferred bending direction is not aligned with the desired direction of movement, it may be difficult for the operator to guide the device to the target.

[0007] Some interventional devices include perforations formed in a helical arrangement along the length of the device. While such a helical arrangement can be more beneficial than a simple alternating cut pattern in reducing favorable bending bias, the helical arrangement itself can create undesirable favorable bending patterns within the device. For example, interventional devices with helical cut patterns are more likely to coil or twist into a curved shape that is consistent with the direction of helical rotation around the device, as opposed to curving in the opposite direction. In certain anatomical situations, this tendency can result in navigation difficulties and / or inhibit the user's ability to smoothly control the device.

[0008] One or more embodiments described herein are configured with cut patterns that effectively distribute bending biases to minimize or eliminate preferred bending directions along the length of the device. Beneficial cut patterns are arranged in a non-helical and non-linear manner, thereby additionally avoiding shape biases inherent in devices that rely on helical or linear cut patterns.

[0009] For convenience, this disclosure may sometimes refer to a "segment" of an elongate member. As used herein, a "segment" is a repeating structural unit of an elongate member. In a typical two-beam configuration, a single segment may be defined as a first pair of opposed beams disposed between two adjacent rings (one proximal ring and one distal ring) and a second pair of opposed beams extending from the distal ring and rotationally offset by approximately 90 degrees from the first pair of opposed beams. In some embodiments, the rotational offset is applied at the segment to segment levels, rather than at every consecutive beam pair.

[0010] Distributed cut patterns provide rotational offsets that optimally spread preferred bending axes using a minimum length of the elongate member and / or using a minimum number of cuts. Distributed cut patterns beneficially maximize the likelihood that the device will contain bending axes aligned with the bends necessary to navigate the patient's vasculature. Embodiments of distributed cut patterns as disclosed herein may achieve these effects by distributing individual bending axes in many different directions within a short length of the device using a minimum number of cuts.

[0011] For example, for a given length of an elongated member, the radial spacing / dispersion of possible beam positions is maximized over the shortest possible length (i.e., with as few cuts as possible), while keeping successive rotational offsets within rotational offset limits. The rotational offset limits set limits for the allowable rotation of a beam pair given the position of the previous beam pair. The rotational offset limits may minimize the effects of fixed spacing artifacts in the device. In some embodiments, the rotational offset limits from one segment to the next are approximately 10 to 30 degrees (i.e., 10 to 30 degrees from the two previous beam pairs).

[0012] In some embodiments, the successive segments are arranged to form an incomplete ramp pattern. The incomplete ramp pattern is formed by intentionally disrupting the distinct spiral pattern with a series of purposefully designed imperfections. In the incomplete ramp pattern, the beams are arranged such that no set of three consecutive segments or beam pairs are spaced according to the same rotational offset. In other words, no set of three segments or beam pairs would form a straight line if the cylindrical periphery of the elongated member were unfolded in a plane. The incomplete ramp pattern includes a variable rotational offset that may vary by 5 to 15 degrees from one segment to the next, for example.

[0013] In some embodiments, successive beam pairs or segments are arranged to form a sawtooth pattern. The sawtooth pattern includes a rotational offset that reverses direction periodically along the length of the elongated member. While a typical spiral pattern simply continues the rotational offset in the same sense through multiple revolutions around the circumference of the elongated member, the sawtooth pattern reaches a first apex position and continues toward a second apex position before reversing direction. Upon reaching the second apex position, the sawtooth pattern then reverses again and continues back toward the first apex. The pattern then repeats in this manner along the desired length of the elongated member. In a two-beam configuration, the first and second apexes may be separated by, for example, about 90 degrees.

[0014]

[0014] In order to explain the manner in which the above and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the accompanying drawings. It being understood that these drawings illustrate only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention, the invention will be described and explained with additional specificity and detail by means of the accompanying drawings in which: [Brief explanation of the drawings]

[0015] [Figure 1]

[0015] An exemplary interventional device that may include the beneficial microfabricated features described herein is shown. [Figure 2]

[0016] 1 illustrates a distal section of an exemplary guidewire device that may include beneficial microfabricated features described herein. [Figure 3A]

[0017] 1 shows various elongated members having straight cut patterns. [Figure 3B] 1 shows various elongated members having straight cut patterns. [Figure 3C] 1 shows various elongated members having straight cut patterns. [Figure 4]

[0018] 1 shows an elongate member having a conventional spiral cut pattern. [Figure 5]

[0019] Examples of elongate members having non-helical and non-linear cut patterns (distributed cut patterns) to beneficially distribute bending axes and minimize or reduce preferred bending directions are shown. [Figure 6A]

[0020] 1 illustrates an exemplary beam pair arrangement for forming a dispersed non-spiral and non-linear cut pattern. [Figure 6B]

[0021] 1 illustrates an exemplary beam pair arrangement for forming an incomplete ramp cut pattern. [Figure 6C]

[0022] 1 illustrates an exemplary beam pair arrangement for forming a sawtooth cut pattern. [Figure 6D] 1 illustrates an exemplary beam pair arrangement for forming a sawtooth cut pattern. [Figure 7]

[0023] FIG. 10 shows the rotational offset difference illustrating the difference in spacing artifacts caused by rotational offset jumps of different sizes. [Figure 8] FIG. 10 shows the rotational offset difference illustrating the difference in spacing artifacts caused by rotational offset jumps of different sizes. DETAILED DESCRIPTION OF THE INVENTION

[0016] Introduction

[0024] The present disclosure relates to interventional devices such as guidewires and catheters that have microfabricated features that provide flexibility while maintaining effective torque and pushability for effective navigation through tortuous vasculature. Microfabricated features include cut patterns that create perforations that increase the flexibility of the interventional device while maintaining good torque capability and not creating a preferred bending direction.

[0017]

[0025] The cut patterns described herein may have different configurations defined by the number of beams resulting from each set of cuts at a given longitudinal position along the elongate member. For example, in a "two-beam" configuration, each cut position along the length of the device includes a pair of opposing cuts, resulting in a pair of opposing axially extending beams. Typically, the two beams in the resulting beam pair are symmetrically spaced around the circumference of the elongate member (i.e., spaced 180 degrees apart). Because of this 180-degree radial symmetry, a beam pair at the 0-degree position is indistinguishable from a beam pair rotationally offset by 180 degrees. Thus, throughout this disclosure, the possible rotational positions for a beam pair range from 0 to 180 degrees, and the 0 and 180-degree positions are said to be equivalent to each other.

[0018]

[0026] While most of the following description will be devoted to embodiments having a two-beam configuration, it will be understood that the same principles may also apply to “one-beam” configurations, “three-beam” configurations, and configurations having more than two beams at each cut position. It will also be understood that in such configurations, different angular symmetries will require some adjustment to the values ​​used in the two-beam configuration. For example, while each pair of cuts in a two-beam configuration will exhibit 180-degree radial symmetry, each cut in a one-beam configuration will not exhibit radial symmetry, each triplet of cuts in a three-beam configuration will exhibit 120-degree radial symmetry, each set of four cuts in a four-beam configuration will exhibit 90-degree radial symmetry, etc. Thus, the spacing of possible distinct rotational positions in a three-beam configuration will range from 0 to 120 degrees, and in a four-beam configuration will range from 0 to 90 degrees, etc. In a one-beam configuration, the spacing of possible rotational positions will range from 0 to 360 degrees.

[0019]

[0027] Continuing with the example of a two-beam configuration, each pair of cuts at a given cut location defines the rotational position of the resulting beam, which in turn defines the preferred bending axis at that location. For a given length of the elongate member, the relative rotational configurations for successive beam pairs determine the type and strength of the preferred bending axis throughout the elongate member.

[0020]

[0028] Typically, each successive beam pair is rotated by 90 degrees plus a constant offset from the previous beam pair. In a "straight" cut pattern, the offset is zero, providing a constant 90-degree rotational offset from one beam pair to the next along the axial length of the elongated member, meaning that successive beam pairs will alternate between a 0-degree position and a 90-degree rotated position. This type of cut pattern leaves the elongated member with preferred bending axes of 0 and 90 degrees relative to the length of the elongated member. A 5-degree offset, for example, will result in a "helical" cut pattern with helically distributed bending axes.

[0021]

[0029] In contrast to such straight and spiral cut patterns, the embodiments described herein provide a dispersion of individual bending axes that is effective to minimize preferred bending directions in the device, which beneficially provides the device with effective navigation capabilities for navigating a patient's vasculature. Overview of interventional devices

[0030] FIG. 1 shows an interventional device 100 (e.g., a catheter or guidewire device) that includes a handle or hub 102 and an elongated member 104. The elongated member 104 has a proximal end 106 coupled to the hub 102 and a distal end 108 extending away from the hub 102. The hub 102 may include paddles, handles, grips, or the like that allow a user to grasp the device and rotate, push / pull, and otherwise manipulate the device 100. The elongated member 104 may be configured as a guidewire or as a catheter. Some embodiments, such as a guidewire, may omit the hub 102 and may be used with an accessory such as a torque device.

[0022]

[0031] Elongated member 104 includes a plurality of perforations cut into its outer surface. The perforations may be formed by cutting one or more pieces of stock material to form a cut pattern that leaves the perforations. The perforations may provide various benefits, including increasing the flexibility / bendability of elongated member 104. In some embodiments, the perforations are arranged to provide improved flexibility (relative to a similar section of stock material without perforations) while maintaining sufficient circumferential structure to transmit torque, thereby maintaining good torque capability of elongated member 104.

[0023]

[0032] The elongate member 104 may be any length necessary to navigate the patient's anatomy to reach the target anatomical region. For example, a typical length may be in the range of about 50 to 300 cm. In catheter embodiments, the outer diameter of the elongate member 104 may be in the range of about 0.010 inches to about 0.150 inches, although larger or smaller diameters may also be utilized according to preference and / or application needs. In guidewire embodiments, the outer diameter of the elongate member 104 may be about 0.014 inches, or in the range of about 0.008 inches to about 0.145 inches, although larger or smaller sizes may also be utilized according to user preference and / or application needs.

[0024]

[0033] The elongate member 104 is formed from a material having a modulus of elasticity, typically from about 3000 MPa to about 4500 MPa, or from about 3500 MPa to about 4000 MPa, in catheter embodiments. In one exemplary embodiment, the elongate member 104 is formed from or includes polyetheretherketone (PEEK). Another polymer with a higher modulus may also be utilized if cost and / or manufacturing requirements warrant it. In some embodiments, the elongate member 104 includes or is formed from a nickel-titanium alloy that has superelastic properties at body temperature. In some embodiments, the proximal portion of the elongate member 104 is formed from stainless steel or another material with similar stress-strain and modulus of elasticity properties. Typically, when the elongate member 104 is formed from two or more different materials, a higher modulus material is used in the more proximal section and a lower modulus material is used in the more distal section.

[0025]

[0034] FIG. 2 illustrates the distal end of an embodiment of an interventional device configured as a guidewire 200. The embodiment illustrated in FIG. 2 may represent the distal end 108 of the guidewire embodiment of elongate member 104 of FIG. 1. The illustrated guidewire 200 includes a core 212 and a tubular structure 214 coupled to the core 212. As shown, a distal section 221 of the core 212 extends into and is surrounded by the tubing 214. In some embodiments, the distal section 221 of the core 212 is ground to gradually taper to a smaller diameter (e.g., about 0.002 inches) at its distal end. The distal section 221 of the core 212 may have a circular cross-section, a rectangular cross-section, or another suitable cross-sectional shape. In this example, the core 212 and the tubing 214 have substantially similar outer diameters at their adjacent attachment points 213.

[0026]

[0035] Tube 214 is bonded to core 212 (e.g., with adhesive, soldering, and / or welding) in a manner that allows torsional forces to be transmitted from core 212 to tube 214 and thereby further distally by tube 214. A medical-grade adhesive 220 may be used to bond tube 214 to core 212 at the distal end of the device to form an atraumatic covering.

[0027]

[0036] Guidewire 200 may also include a coil 224, which may be disposed within tube 214 so as to be disposed between the outer surface of the distal section of core 212 and the inner surface of tube 214. Coil 224 may be formed from a radiopaque material such as platinum. The coil 224 shown is formed as a single, unitary piece. In alternative embodiments, coil 224 includes multiple separate sections stacked, positioned adjacent to one another, and / or interlocked by entanglement.

[0028]

[0037] The tube 214 includes micro-machined perforations configured to provide effective flexibility and torque capability for the interventional device without creating a preferred bending direction. Some embodiments may additionally or alternatively include cuts formed in the core itself, such as along the distal section 221 of the core 212. Cutting Pattern

[0038] 3A-3C show embodiments of straight cut patterns, with FIG. 3A showing a typical "2-beam" straight cut pattern, FIG. 3B showing a typical "1-beam" straight cut pattern, and FIG. 3C showing a typical "3-beam" straight cut pattern.

[0029]

[0039] 3A, the elongated member 600 includes a plurality of axially extending beams 632 and circumferentially extending rings 634. The elongated member 600 has a two-beam cut pattern because two circumferentially opposing beams 632 are disposed between each pair of adjacent rings 634. The cut pattern shown is a straight cut pattern because no rotational offset is applied from one segment to the next.

[0030]

[0040] As noted above, a "segment" is a repeating structural unit of the elongate member. In some embodiments, a single segment may be defined as a first pair of opposing beams 632 disposed between two adjacent rings 634 (one proximal and one distal ring) and a second pair of opposing beams 632 extending from the distal ring and rotationally offset by approximately 90 degrees from the first pair of opposing beams 632. The linear arrangement of the segments results in the formation of a preferred bending direction aligned with the perforations in the elongate member 600.

[0031]

[0041] 3B shows an elongated member 900 having multiple beams 932 and rings 934. The elongated member 900 is an example of a one-beam cut pattern because a single beam 932 is disposed between each pair of adjacent rings 934. In such a one-beam cut pattern, a single segment may be defined as a first beam 934 disposed between two adjacent rings 934 (one proximal and one distal ring) and a second beam 932 extending from the distal ring and rotationally offset by approximately 180 degrees from the first beam 932. Similar to the elongated member 600, the elongated member 900 has a straight cut pattern because no rotational offset is applied from one segment to the next, i.e., segment by segment.

[0032]

[0042] 3C shows an elongated member 1000 having multiple beams 1032 and rings 1034. The elongated member 1000 is an example of a three-beam cut pattern because three beams 1032 are disposed between each pair of adjacent rings 1034. In such a three-beam cut pattern, a single segment may be defined as a first triad of beams 1032 disposed between two adjacent rings 1034 (one proximal and one distal ring) and a second triad of beams 1032 extending from the distal ring and rotationally offset by approximately 60 degrees from the first triad. Similar to elongated members 600 and 900, the elongated member 1000 has a linear cut pattern because no rotational offset is applied from one segment to the next, i.e., segment by segment.

[0033]

[0043] It will be appreciated from the foregoing examples that various cut patterns may be utilized. For example, cut patterns providing four or more beams between each pair of adjacent rings may be utilized according to the needs of a particular application. Generally, the greater the number of beams remaining between each pair of adjacent rings, the proportionally greater the stiffness of the elongate member.

[0034]

[0044] 4 illustrates an exemplary embodiment of a spiral cut pattern intended to minimize preferred bend orientations in a microfabricated guidewire or catheter device. As shown, cuts made in elongate member 300 leave pairs of opposing beams located on opposite sides of the longitudinal axis of the hollow member. Each pair of such cuts forms two beams 332 (extending substantially axially) connecting adjacent rings 334 (extending substantially laterally and circumferentially).

[0035]

[0045] A rotational offset is applied to each successive segment of elongate member 300 to form a spiral pattern. As used herein, a "rotational offset" is the angular rotation between two adjacent segments. The rotational offset is therefore applied from one segment to the next, i.e., segment by segment, even though the individual cuts within a segment may also be offset from one another.

[0036]

[0046] In an exemplary embodiment, a single segment may be defined as a first pair of opposing beams 332 disposed between two adjacent rings 334 (one proximal and one distal) and a second pair of opposing beams 332 extending from the distal ring and rotationally offset by approximately 90 degrees from the first pair of opposing beams 332. The cuts are arranged to create a substantially consistent rotational offset from one segment to the next. For example, the illustrated embodiment depicts a rotational offset of approximately 5 degrees from one segment to the next. When multiple consecutive segments with such angular offsets are formed, the resulting pattern of beams along a sufficient length of the elongate member 300 overlaps around the axis of the elongate member 300 in a continuously rotating helical pattern.

[0037]

[0047] This type of helical arrangement may also be used in embodiments having different cut patterns. For example, an elongate member having a "one-beam" or "bypass" cut pattern, where each cut leaves a single beam between each set of adjacent rings, may have a constant rotational offset between each successive cut or set of cuts.

[0038]

[0048] The spiral arrangement may also be applied to embodiments having three or more beam cut patterns. For example, the same spiral forming rotation offset may be applied to a three beam embodiment (such as that shown in FIG. 3C) or an embodiment having four or more beams between adjacent rings.

[0039]

[0049] A spiral cut pattern, such as that depicted in FIG. 4, may beneficially minimize some of the elongate member's tendency to bend in a preferred direction. However, the spiral structure itself defines a preferred bending curvature. An elongate member having a spiral cut pattern is more likely to coil or twist into a curvature that is consistent with the direction of helix rotation as opposed to curving in the opposite direction. Dispersion Pattern

[0050] FIG. 5 shows a section of an elongate member 500 having a distributed cut pattern. The cuts are beneficially arranged to effectively distribute the rotational spacing of each beam pair. In this embodiment, the non-helical and non-linear cut pattern effectively eliminates or minimizes preferred bending directions along the length of elongate member 500. The cut pattern depicted in FIG. 5 is "non-helical" because, in contrast to a helical cut pattern, the resulting beams of elongate member 500 are not arranged in a helical pattern about the axis of elongate member 500.

[0040]

[0051] The cut pattern depicted in FIG. 5 is also “non-linear” because there are rotational offsets applied to successive segments of the device, and the rotational offsets applied to the segments making up elongate member 500 are not necessarily equal or constant from one segment to the next, i.e., from segment to segment.

[0041]

[0052] A spiral is generally defined to follow a curvature on a conical or cylindrical surface that would result in a straight line if the surface were unfolded onto a plane. Using the spiral cut pattern shown in FIG. 4 as an example, any curve tracing the arrangement of beams / segments along the length of elongated member 300 would form a straight line if elongated member 300 were cut open and "unfolded" onto a plane. Conversely, using the cut pattern shown in FIG. 5, any line tracing the arrangement of beams / segments along the length of elongated member 500 would not form a straight line. For example, given a set of any three consecutive beam pairs or segments along the length of elongated member 500 in FIG. 5, the rotational positions of the three consecutive beam pairs or segments would not form a straight line if elongated member 500 were unfolded onto a plane.

[0042]

[0053] A helix is ​​also typically understood to require at least one complete revolution around the conical / cylindrical surface on which it resides. Thus, a cut pattern may also be considered non-helical if the resulting rotational arrangement of beam pairs or segments does not form a pattern that completely overlaps around the circumference of the elongated member by at least one degree before changing direction. For example, if the cylindrical surface of an elongated member is unfolded into a plane and the plane contains a series of three or more segments that are positionally aligned with a line, the series of segments would still not constitute a helix if the line does not overlap around the circumference of the elongated member by at least one degree.

[0043]

[0054] A rotational offset may be applied from one beam pair to the next. Alternatively, a rotational offset may be applied to the segmented elongated member to segment the level. As described above, each segment of the elongated member may be defined as a first pair of opposing beams between the proximal and distal rings and a second pair of beams extending from the distal ring that is offset by approximately 90 degrees from the first pair of beams. Alternative embodiments may apply a distributed rotational offset pattern between segments of different sizes and / or between segments with different internal offsets. For example, some embodiments may include segments having three or more pairs of beams (and three or more corresponding rings) and / or having internal offsets different from 90 degrees. Furthermore, even though the illustrated example represents a two-beam cut pattern in which each pair of opposing cuts results in two circumferentially opposed beams, it will be appreciated that a distributed offset pattern may also be applied to one-beam cut patterns (see FIG. 3B), three-beam cut patterns (see FIG. 3C), and patterns having four or more beams between adjacent rings.

[0044]

[0055] Figure 6A graphically compares an example of a distributed cut pattern with a conventional helical cut pattern. As shown, the helical cut pattern applies a constant rotational offset from one segment to the next along the length of the elongated member, i.e., segment by segment. The distributed cut pattern applies a rotational offset that effectively distributes the bending axes without relying on the helical cut pattern.

[0045]

[0056] If the starting beam pair is arbitrarily assigned to the zero degree position, successive beam pairs are rotationally offset to maximize the diametrical distribution of beam positions across the available 180 degree radial space as quickly (i.e., with as few cuts as possible). However, in the illustrated embodiment, rotational offset constraints are also applied to prevent the formation of fixed spacing artifacts (discussed further below in connection with FIGS. 7 and 8).

[0046]

[0057] The rotational offset limit defines a limit on the allowable rotational “jump” from one beam pair to the next, or from one segment to the next, i.e., per segment. Rotational offset limits having a value of approximately 10 to 30 degrees from one segment to the next, or rotating successive beam pairs by 90 degrees plus or minus that value, have been shown to provide an effective distribution of bending without causing excessively fixed spacing artifacts. For example, the rotational offset limit may restrict the rotation from one beam pair to the next to a value within the range of approximately 60 to 120 degrees, or approximately 70 to 110 degrees, or approximately 80 to 100 degrees. Other embodiments may utilize other rotational offset limits, or even omit the rotational offset limit, depending on the needs of a particular product and / or application. For example, if the resulting spacing artifacts are acceptable for a particular application, the rotational offset limit may be increased to a value greater than 30 degrees.

[0047]

[0058] The exemplary dispersion cut pattern shown in FIG. 6A utilizes a 30-degree rotational offset restriction. As shown, the first beam pair is placed at an arbitrary 0-degree position, and the second beam pair is placed at 90 degrees. The maximum remaining gaps within the available 180-degree space are between 0 and 90 degrees and between 90 and 180 degrees (although 0 and 180 degrees represent the same position). Placing the next beam pair near the midpoint of one of these gaps, such as at 45 degrees, best distributes the bending axes of the device. However, placing the next beam pair at 45 degrees violates the 30-degree rotational offset restriction. Therefore, the next beam pair is placed near the midpoint of the remaining gap without violating the rotational offset restriction. In this example, the third beam pair is placed at 30 degrees. The fourth beam pair is placed at 120 degrees, which is 90 degrees from the third beam pair. In this particular example, every other beam pair is offset 90 degrees from the previous beam pair. Alternative embodiments need not necessarily follow this particular pattern.

[0048]

[0059] Continuing with the distribution example of FIG. 6A, the largest remaining positional gaps are now between 30 and 90 degrees and between 120 and 180 degrees. The fifth and sixth beam pairs are positioned at 60 and 120 degrees, respectively. The remaining positional gaps are now located every 30 degrees (i.e., between 0 and 30 degrees, between 30 and 60 degrees, between 60 and 90 degrees, etc.). As the pattern continues, the remaining angular positions are filled in a manner that radially spaces the beam pairs as quickly as possible without violating the rotational offset constraints.

[0049]

[0060] In the illustrated example, the available angular positions are provided with a granularity of 10 degrees. In other words, all angular positions may be considered filled when every 10-degree increment is filled. Thus, the illustrated pattern may have beam pairs positioned at approximately every 10-degree position before resetting. Such an arrangement is referred to herein as having a "positional granularity" of 10 degrees. Alternative embodiments may utilize different positional granularities, such as, for example, 0.1, 0.5, 1, 3, 5, 10, 15, 18, 20, 25, or 30 degree granularities.

[0050]

[0061] It will be understood that the exact positioning illustrated may be adjusted, and the pattern shown in FIG. 6A is only exemplary. For example, positional gaps may be filled using a different specific sequence, as long as the rotational jumps are within predetermined rotational offset limits. Preferably, when filling a gap between rotational positions, the next beam pair is positioned to be near the approximate center of the largest remaining positional gap without violating the rotational offset limits. For example, if there is a gap between the 0-degree and 30-degree positions, the segments may be positioned between the 10- and 20-degree positions.

[0051]

[0062] Additionally, alternative embodiments may utilize positional granularity that fills positions greater than or less than 10 degrees. If fewer segments are used before resetting the pattern, the size range of each suitable position will be larger; if more segments are used before resetting the pattern, the size range will be smaller. Some embodiments may include approximately 6 to 36 beam pairs, or approximately 10 to 18 beam pairs, before the availability of filled angular positions within a 180-degree radial space is reset. Other embodiments may include many more beam pairs before the available positions are reset. As the predetermined positional granularity is lowered, the number of beam pairs required to fill all available angular positions increases. Thus, a device with 1-degree positional granularity uses 180 beam pairs to fill 180 available angular positions. Also, since there are multiple ways to fill the available angular positions according to the predetermined parameters (e.g., positional granularity and rotational offset limitations) of the selected dispersion pattern, the dispersion cut pattern need not repeat itself exactly after resetting. Thus, as used herein, the terms "reset," "resetting," and the like refer to resetting the availability of angular positions within a 180 degree radial space after it has been filled by a beam pair, and the terms do not necessarily imply that subsequent refilling of angular positions along the next section of the elongate member will exactly repeat the previous pattern. In fact, in at least some embodiments, the entire length of the dispersion pattern may not be repeating.

[0052]

[0063] It will be understood that the above principles may also be applied to embodiments having a one-beam arrangement, an embodiment having a three-beam arrangement, or an embodiment having four or more beam arrangements. For example, the one-beam embodiment depicted in FIG. 5 may be modified to follow a non-helical and non-linear cut pattern rather than the spiral cut pattern shown. The same principles as above may be applied to one-beam embodiments, except that the range of angular positions to be satisfied extends to 360 degrees. Similarly, the same principles may generally be applied to three-beam embodiments, except that the range of angular positions to be satisfied extends to 120 degrees. Incomplete Lamp Pattern

[0064] FIG. 6B graphically illustrates another embodiment of a non-helical cut pattern formed by intentionally perturbing an otherwise helical pattern with a series of purposefully designed imperfections. This type of cut pattern is referred to herein as an "imperfect ramp" pattern. Beneficially, the intentional deviation from the imperfect ramp pattern serves to reduce or prevent remnants of the desired twist and curvature inherent in a true helical arrangement. As shown, the segments are arranged such that no three consecutive beam pairs or segments are spaced according to the same rotational offset. In other words, the three beam pairs or segments are not arranged to form a straight line when the cylindrical elongate member is unfolded in a plane.

[0053]

[0065] In contrast to the partial ramp pattern of Figure 6B, a true helix pattern is typically formed by rotationally offsetting each successive segment or each successive beam pair by a constant value. For example, a true helix pattern in a two-beam configuration can be formed by rotationally offsetting each successive cut pair by a constant value of 5 degrees, 85 degrees, 95 degrees, or some other constant value that is not a multiple of 90 degrees.

[0054]

[0066] In a partial ramp cut pattern, the correction value is intentionally made variable rather than constant. For example, as in FIG. 6B, a partial ramp pattern can be formed by rotationally offsetting each successive beam pair by a constant value plus or minus a variable correction value. Rotational offsets that include constant values ​​plus or minus a variable correction value are referred to herein as "partial rotational offsets."

[0055]

[0067] The variable correction value may range from 5 to 15 degrees. In other embodiments, the variable correction value may range from 2.5 to 30 degrees, or some other range suitable for the intended purpose of the resulting device. Preferably, the variable correction value is randomly selected for each segment or beam pair to which it is applied, with the upper and lower limits of the random selection being determined by the range of correction values ​​(e.g., 5 to 15 degrees). Typically, the constant value portion of the offset is 180 degrees for a 1-beam pattern, 90 degrees for a 2-beam pattern, 60 degrees for a 3-beam pattern, etc.

[0056]

[0068] Alternative embodiments may apply incomplete ramp patterns between segments of different sizes and / or between segments with different internal offsets. For example, some embodiments may include more than two pairs of beams (and more than two corresponding rings) and / or segments with internal offsets different from 90 degrees. Furthermore, while the illustrated example shows a two-beam cut pattern in which each pair of opposed cuts results in two circumferentially opposed beams, it will be understood that the distributed offset pattern may also be applied to one-beam cut patterns (see FIG. 3B), three-beam cut patterns (see FIG. 3C), and patterns having four or more beams between adjacent rings. Sawtooth Pattern

[0069] 6C illustrates another embodiment of a non-helical cut pattern, referred to herein as a "sawtooth" pattern. Similar to the other non-helical cut patterns described herein, the sawtooth cut pattern advantageously avoids preferred bending axes while also limiting the preferred curvature direction inherent in the helical pattern. In contrast to the helical pattern, the sawtooth cut pattern periodically reverses the direction of the rotational offset.

[0057]

[0070] Both the sawtooth and spiral patterns of FIG. 6C have an angular offset of approximately 10 degrees between adjacent segments, with each pair of cuts within each segment offset by 90 degrees. The spiral pattern simply continues these offsets in the same direction through multiple revolutions around the circumference of the elongated member, while the sawtooth pattern reaches a first apex position and continues toward a second apex position before reversing direction. Upon reaching the second apex position, the sawtooth pattern then reverses again and continues back toward the first apex. The pattern then repeats along the desired length of the elongated member.

[0058]

[0071] For example, the first apex position is set at approximately 90 degrees (i.e., 90 degrees for the first cut pair of the segment and 180 degrees for the second cut pair of the segment). Once the first apex position is reached, the pattern reverses toward the second apex position. In this embodiment, the second apex position is set at approximately 0 degrees (i.e., 0 degrees for the first cut pair of the segment and 90 degrees for the second cut pair of the segment). Alternative embodiments may include other apex positions. Given an arbitrary zero-degree starting position, the first apex position may be less than 360 degrees in a one-beam configuration, less than 180 degrees in a two-beam configuration, less than 120 degrees in a three-beam configuration, etc. Preferably, the first apex position is approximately 180 degrees for a one-beam configuration, 90 degrees for a two-beam configuration, 60 degrees for a three-beam configuration, etc.

[0059]

[0072] As noted above, the angular offset from one segment to the next, i.e., per segment, is approximately 10 degrees in the sawtooth pattern of FIG. 6C . In other embodiments of sawtooth cut patterns, the angular offset may be greater than or less than 10 degrees, such as from about 5 degrees to about 30 degrees. Additionally, or alternatively, portions of the cut pattern between vertices may include variable offsets. For example, one or more portions between vertices may include incomplete rotational offsets as described above. FIG. 6D illustrates one such embodiment. The sawtooth cut pattern depicted in FIG. 6D follows a sawtooth pattern similar to the pattern depicted in FIG. 6C , but also includes several sections of variable / incomplete rotational offsets between vertices.

[0060]

[0073] Alternative embodiments may apply sawtooth patterns between segments of different sizes and / or between segments with different internal offsets. For example, some embodiments may include more than two pairs of beams (and more than two corresponding rings) and / or segments with internal offsets different from 90 degrees. Furthermore, while a two-beam cut pattern is shown in which each pair of opposed cuts results in two circumferentially opposed beams, it will be understood that the distributed offset pattern may also be applied to one-beam cut patterns (see FIG. 3B), three-beam cut patterns (see FIG. 3C), and patterns having four or more beams between adjacent rings. Spacing artifacts

[0074] Figure 7 shows an example of undesirable spacing artifacts that can occur when rotational offset constraints are not applied. Figure 7 shows a section of elongated member 700 having a first segment 750a and a second segment 750b. First segment 750a comprises a first pair of beams 730a (only one of which is visible in this view) and a second pair of beams 730b and 730c offset by 90 degrees from the first pair. Second segment 750b comprises a first pair of beams 730d and 730e and a second pair of beams 730f and 730g offset by 90 degrees from the first pair. Each beam within a pair is circumferentially spaced 180 degrees from its corresponding beam. The second segment 750b is offset by 45 degrees from the first segment 750a, which positions the first pair of beams 730d and 730e at 45 degrees offset from the first pair of beams 730a, and the second pair of beams 730f and 730f at 45 degrees offset from the second pair of beams 730b and 730c.

[0061]

[0075] Applying such a 45-degree offset from first segment 750a to second segment 750b is desirable because it places the bending axis of second segment 750b midway between the bending axis of first segment 750a. However, a 45-degree jump also results in inter-segment beam spacing that can leave overly rigid artifacts in portions of elongated member 700. In the illustrated member 700, beam 730d is only spaced 45 degrees from beam 730b, while beam 730e is spaced 135 degrees from beam 730b. Similarly, beam 730e is only spaced 45 degrees from beam 730c, while beam 730d is spaced 135 degrees from beam 730c. This disproportionate spacing may be undesirable because the areas of elongate member 700 with the smaller spacing may be too rigid and / or the areas with the larger spacing may be too flexible.

[0062]

[0076] In contrast, a more limited jump in rotational offset applied from one segment to the next minimizes the discrepancy in beam spacing between segments. For example, FIG. 8 shows a section of elongated member 800 having a more limited rotational offset of approximately 20 degrees applied between first segment 850a and second segment 850b. As in elongated member 700 of FIG. 7, first segment 850a comprises a first pair of beams 830a and a second pair of beams 830b and 830c, while second segment 850b comprises a first pair of beams 830d and 830e and a second pair of beams 830f and 830g. However, because second segment 850b is offset from first segment 850a by a more limited 20 degrees, the discrepancy in spacing between beams 830b, 830c, 830d, and 830e is less pronounced. Beam 830d is diverged 70 degrees from beam 830b, and beam 830e is diverged 110 degrees from beam 830b. Similarly, beam 830e is diverged 70 degrees from beam 830c, and beam 830d is diverged 110 degrees from beam 830c. Thus, a spacing discrepancy still exists between the segments, but it can be controlled to an appropriate degree by applying appropriate rotational offset limits.

[0063]

[0077] As used herein, the terms "approximately," "about," and "substantially" refer to an amount or condition that approximates a stated amount or condition that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" can refer to an amount or condition that deviates from the stated amount or condition by less than 10%, or by less than 5%, or by less than 1%, or by less than 0.1%, or by less than 0.01%.

[0064]

[0078] The present invention may be embodied in other forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the present invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. an elongate member having a wall and an internal lumen, the elongate member including a plurality of perforations extending through the wall and exposing the lumen, the plurality of perforations defining a plurality of axially extending beams and a plurality of circumferentially extending rings arranged in a series of two-beam pair segments, each segment including a first beam pair of circumferentially opposed beams and a second beam pair of circumferentially opposed beams that are rotationally offset by 90 degrees from the circumferentially opposed beam of the first beam pair, the series of segments arranged in a sawtooth pattern including a rotational offset that periodically reverses direction; the beams of each pair of beams in said sawtooth pattern are circumferentially symmetrically spaced 180 degrees apart; each rotational offset from segment to segment within said sawtooth pattern is between 5 degrees and 30 degrees; the sawtooth pattern includes a first apex and a second apex; the rotational offset of the sawtooth pattern reverses direction upon reaching the first or second apex; An interventional device including multiple rotational offsets between each first vertex and second vertex.

2. The device of claim 1 , wherein the first and second vertices are separated by 90 degrees.

3. The device according to any one of claims 1 to 2, wherein the interventional device is a microcatheter device or a guidewire device.

4. 4. The device of claim 3, wherein the interventional device is a guidewire including a core, and the elongated member is formed as a tubular structure coupled to the core such that a distal section of the core extends within at least a portion of the tubular structure.

5. The device of claim 4 , further comprising one or more coils disposed within the tubular structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tubular structure.

6. The device of any one of claims 4 to 5, wherein the core is formed from stainless steel or nitinol.

7. The device of any one of claims 4 to 6, wherein the tubular structure is formed from Nitinol.

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