Soft-tip intravascular devices
The guidewire device addresses flexibility and torque transmission issues by using a moldable tip and core-tube configuration with beam and ring patterns, ensuring effective navigation and reducing vascular deformation.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- SCIENTIA VASCULAR INC
- Filing Date
- 2024-04-13
- Publication Date
- 2026-04-27
AI Technical Summary
Existing guidewire devices face limitations in flexibility and torque transmission, particularly when navigating complex vascular pathways, leading to potential deformation and hindrance in guiding operations.
A guidewire device with a moldable tip and increased flexibility, featuring a core and outer tube configuration with specific beam and ring patterns, allowing for enhanced bending and torque transmission without deforming the tip.
The device maintains tip shape and flexibility, reducing deformation and vascular damage by elastically storing compressive energy, enhancing guidance and maneuverability in vascular systems.
Smart Images
Figure 2026513462000001_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications
[0001] This application claims the benefit and priority of U.S. Utility Application No. 18 / 634,267, filed on April 12, 2024, and U.S. Provisional Application No. 63 / 459,149, filed on April 13, 2023, both entitled "SOFT - TIP INTRAVASCULAR DEVICES", and the entire disclosure of the applications mentioned above is hereby incorporated by reference in its entirety into this specification.
Background Art
[0002]
[0002] Guidewire devices are often used to guide or direct a catheter or other interventional device to a target anatomical site within a patient's body. Typically, a guidewire is inserted into a patient's vasculature to reach a target site, such as, for example, near or within the patient's heart, neurovascular tissue, etc. Fluoroscopic imaging is commonly used to assist in guiding the guidewire to the target site. In many cases, the guidewire is left in a fixed position within the body during the intervention procedure and can be used to direct multiple catheters and other interventional devices to the target anatomical site.
[0003]
[0003] Some guidewire devices are configured with a curved or bent tip so that an operator can more effectively guide the device within a patient's vasculature. When using such a guidewire, the operator can apply torque to the proximal end of the guidewire or an attached proximal handle to orient and direct the tip in a desired direction. Thereafter, the operator may further direct the guidewire within the patient's vasculature in the desired direction.
[0004]
[0004] Adjusting the flexibility of the guidewire device, particularly the distal portion of the guidewire device, is also a concern. In many situations, relatively high flexibility is desirable to obtain sufficient flexibility of the guidewire so that it can be bent to reach the target area through the meandering bends and curves of the vascular pathway. For example, directing a guidewire to a part of the neurovascular system requires passing the guidewire through curved pathways such as the carotid siphon or other meandering routes.
[0005]
[0005] Another concern with respect to guidewire devices is the ability of a given guidewire device to transmit torque from the proximal end to the distal end (i.e., the "torque" of the guidewire device). As the guidewire is further inserted into the vascular passage, the amount of frictional surface contact between the guidewire and the vascular system increases, which hinders the guidewire from moving easily through the vascular passage. A guidewire with good torque can counteract frictional forces by transmitting the torque force applied at the proximal end to the entire guidewire to the distal end, causing the guidewire to rotate.
[0006]
[0006] Some guidewire devices include a distally positioned, finely machined, small-diameter tube at the distal end of the guidewire core to direct the applied torsional force further toward the distal end of the device. Since the torsional force is transmitted mainly through the outer portion of the cross-section of the member, the tube is configured to provide a path that increases the transmission of torque compared to the amount of torque transmitted by the guidewire core that is not covered by the tube. Typically, such tubes are formed from a superelastic material such as nitinol to have good flexibility in addition to obtaining the desired torque transmission characteristics.
[0007]
[0007] While such guidewire devices offer many advantages, some limitations remain. For example, many of the design characteristics of guidewires with torque transmission tubes are designed to increase torque transmission, but they act on and limit the flexibility of the guidewire tip. Also, curved or bent guidewire tips can deform as the distal end of the guidewire is pressed against the patient's blood vessel wall, potentially hindering the guidance operation of the guidewire device. In such cases, what is needed is a configuration that enhances the flexibility and / or moldability of the guidewire device. [Overview of the Initiative]
[0008]
[0008] The present disclosure relates to a guidewire device having a moldable tip and increased flexibility. In one embodiment, the guidewire device includes a core having a proximal and a distal portion. The distal portion includes a terminal portion proximal to the distal end of the core, where the length of the terminal portion is greater than the distance between the proximal end of the terminal portion and the distal portion. The terminal portion can be curved or bent to form a fold along a distinct line.
[0009]
[0009] Some embodiments further include a tube having a proximal and distal portion, wherein the distal portion of the core is coupled to the core such that it passes through the tube and is surrounded by the tube. The distal portion of the tube may be coupled to the distal portion of the core at a distal attachment point located proximal to the distal end of the core.
[0010]
[0010] In some embodiments, the tube includes an opening consisting of a plurality of axially extending beams and a plurality of circumferentially extending rings. The tube may include a corrugated ring section, each having a circumference that varies axially along the longitudinal axis of the device. The rings in the corrugated ring section may include a sinusoidal pattern.
[0011]
[0011] In some embodiments, the tube includes a nonlinear beam section in which each beam has a centerline passing through the center of the nonlinear beam. For example, the beam can take the shape of an "S" or a "C".
[0012]
[0012] In some embodiments, the tube includes a buckling portion formed between a first portion and a second portion. The first portion includes a plurality of axially extending beams arranged in a first pattern having a rotational offset in a first direction, and the second portion includes a plurality of axially extending beams arranged in a second pattern having a rotational offset in a second direction opposite to the rotational offset in the first direction.
[0013]
[0013] In some embodiments, the tube includes a thin beam section in which the ratio of the outer diameter of the tube to the width of the beam (i.e., in the circumferential direction relative to the length along the longitudinal direction) is about 11.3 or more.
[0014]
[0014] This summary is provided in a concise form to introduce a selection of concepts that will be described in more detail below. This summary is not intended to identify the main or essential features of the claimed subject matter, nor is it intended to be used to define the scope of the claimed subject matter.
[0015]
[0015] Various objects, features, characteristics and advantages of the present invention will become apparent and more readily understood from the following description of embodiments, all of which are referenced in conjunction with the accompanying drawings and claims, which constitute part of this specification. In the drawings, similar reference numerals may be used to designate corresponding or similar parts in different figures, and each element depicted is not necessarily drawn on a scale. [Brief explanation of the drawing]
[0016] [Figure 1]
[0016] This figure shows an exemplary embodiment of a guidewire device that includes a core and an outer tube and can use one or more of the components described herein. [Figure 2]
[0017] This figure shows an exemplary embodiment of the core of a guidewire device. [Figure 3]
[0018] Figures 3A, 3B, 3C, and 3D show exemplary distal portions of the core. [Figure 4]
[0019] This figure shows an exemplary embodiment of the distal portion of a guidewire device, including a terminal portion proximal to the distal end of the device and a distal mounting point proximal to the terminal portion. [Figure 5]
[0020] This figure shows an exemplary embodiment of an outer tube comprising multiple circumferentially extending rings and multiple axially extending beams, wherein the circumferentially extending rings include a corrugated portion that changes axially along the device. [Figure 6]
[0021] This figure shows an exemplary embodiment of an outer tube comprising multiple circumferentially extending rings and multiple axially extending beams, including a nonlinear beam section in which the axially extending beams are formed in an "S" shape. [Figure 7]
[0022] This figure shows an exemplary embodiment of an outer tube comprising multiple circumferentially extending rings and multiple axially extending beams, including a nonlinear beam section in which the axially extending beams are formed in a "C" shape. [Figure 8]
[0023] This figure shows an exemplary embodiment of an outer tube comprising a plurality of circumferentially extending rings and a plurality of axially extending beams, the outer tube comprising: a first portion in which the plurality of axially extending beams are arranged in a first pattern having a rotational offset in a first direction; a second portion in which the plurality of axially extending beams are arranged in a second pattern having a rotational offset in a second direction opposite to the rotational offset in the first direction; and a buckling portion formed between the first portion and the second portion. [Figure 9]
[0024] Figures 9A, 9B, 9C, and 9D illustrate an exemplary asymmetric section of the outer tube, which includes a plurality of circumferentially extending rings and a plurality of axially extending beams, wherein the axially extending beams are positioned on one side of the outer tube with respect to a first plane containing the longitudinal axis of the outer tube, and the asymmetric section shows that pairs of continuous beams in the asymmetric section are not aligned in the rotational direction (i.e., aligned in the same circumferential position). [Figure 10]Figures 10A and 10B are exemplary asymmetric portions of an outer tube, including a plurality of circumferentially extending rings and a plurality of axially extending beams, wherein the axially extending beams are disposed on one side of the outer tube with respect to a first plane including the longitudinal axis of the outer tube, and a pair of continuous beams in the asymmetric portion are not aligned in the rotational direction (i.e., aligned at the same circumferential position), showing an asymmetric portion. [Figure 11] Figures 11A and 11B are exemplary asymmetric portions of an outer tube, including a plurality of circumferentially extending rings and a plurality of axially extending beams, wherein the axially extending beams are disposed on one side of the outer tube with respect to a first plane including the longitudinal axis of the outer tube, and a pair of continuous beams in the asymmetric portion are not aligned in the rotational direction (i.e., aligned at the same circumferential position), showing an asymmetric portion.
Mode for Carrying Out the Invention
[0017] Overview of an Exemplary Guidewire Device
[0025] FIG. 1 schematically shows a guidewire device 100 suitable for using one or more features of the present disclosure. The illustrated guidewire 100 includes a core 102 and an outer tube 106. The core 102 includes a distal portion 104 (i.e., distal core) that extends into the outer tube 106 as shown. The distal core 104 may be tapered continuously or in one or more discrete portions, so that the distal portion has a smaller diameter and greater flexibility than the proximal portion. For example, the distal portion 104 may be gradually tapered to a smaller diameter at the distal end. In some embodiments, the distal portion 104 may be flattened into a ribbon-like shape having a flat, rectangular, or oval cross-section.
[0018]
[0026] The core 102 and tube 106 are typically formed from different materials. For example, tube 106 is preferably formed from a relatively flexible and elastic material such as nitinol, while core 102 may be formed from a relatively less flexible and elastic material such as stainless steel. Forming core 102 from stainless steel may be advantageous because it allows the distal tip to retain its shape when selectively bent / shaped by the operator, and because stainless steel has a sufficient modulus of elasticity to produce more responsive translational motion. While these materials are currently preferred, other suitable materials such as polymers or other metals / alloys may also be used.
[0019]
[0027] In the illustrated apparatus, the outer diameter of the core 102 and the inner diameter of the tube 106 are substantially equal in diameter at the mounting point where the core 102 enters the tube 106. In some embodiments, the outer diameter of the core 102 and the inner diameter of the tube 106 have different diameters at the mounting point, and the difference in diameter is compensated by welding, soldering, adhesive, or other structural mounting means, or by positioning a portion of a centering mechanism (e.g., a centering coil, braid, or tube) at the mounting point, and / or by the use of a bushing structure. The tube 106 is coupled to the core 102 (e.g., using adhesive, soldering, and / or welding) in a manner that beneficially allows torsional forces to be transmitted from the core 102 to the tube 106, and thereby transmitted further distally by the tube 106. The tube 106 may be coupled to the core wire 102 at the distal end of the apparatus using medical-grade adhesive or other suitable material to form a non-traumatic covering.
[0020]
[0028] The outer tube 106 may include a cut pattern that forms an opening 108 in the tube 106. The pattern of the opening 108 may include an axially extending "beam" and a circumferentially extending "ring," as shown, and / or may be arranged to give the tube 106 desired flexibility, including, for example, a reduction or elimination of a preferred bending direction that promotes a preferred bending direction, or an increase in the flexibility gradient along the longitudinal axis. Examples of cut patterns and other guidewire device features that may be used in the guidewire devices described herein are described in detail in U.S. Patent Applications Publications 2018 / 0193607 and 2018 / 0071496, and Patent Cooperation Treaty Application PCT / US2018 / 034756, the full texts of which are incorporated herein by reference.
[0021]
[0029] The proximal portion of the guidewire device 100 (the portion extending proximally from the tube 106) extends proximally to the length necessary to provide a sufficient guidewire length for delivery to the target anatomical area. The guidewire device 100 typically has a length ranging from about 50 cm to about 350 cm, depending on the requirements of the particular application. The tube 106 may have a length ranging from about 20 cm to about 65 cm, more typically from about 30 cm to about 55 cm, for example, from about 35 cm to about 45 cm.
[0022]
[0030] The guidewire device 100 may have a diameter ranging from approximately 0.356 mm (0.014 inches) to approximately 0.889 mm (0.035 inches), although larger or smaller sizes may be used as required for a particular application; however, the features of the present disclosure are not necessarily limited to a specific guidewire size. Some embodiments may have outer diameters corresponding to standard guidewire sizes such as 0.356 mm (0.014 inches), 0.406 mm (0.016 inches), 0.457 mm (0.018 inches), 0.610 mm (0.024 inches), 0.889 mm (0.035 inches), or other such sizes common to guidewire devices. The distal portion 104 of the core 102 may taper to a diameter of approximately 0.051 mm (0.002 inches), or to a diameter in the range of approximately 0.025 mm (0.001 inches) to 0.127 mm (0.005 inches). In some embodiments, the distal tip may be flattened (e.g., to a rectangular cross-section) to further enhance bending flexibility while minimizing the reduction in cross-sectional area required for tensile strength. In such embodiments, the cross-section may have dimensions of, for example, approximately 0.025 mm (0.001 inches) × 0.076 mm (0.003 inches). In some embodiments, the tube 106 has a length in the range of approximately 3 cm to 100 cm.
[0023] Exemplary core features
[0031] Figure 2 shows an exemplary embodiment of a core 102 in which the distal core 104 tapers at the discrete portion. The distal core 104 may include an end portion 116 disposed proximally adjacent to the distal end 114 of the core 102. The end portion 116 may be flattened into a ribbon shape having a flat, rectangular, or oval cross-section. Figure 3A schematically shows an end portion 116 that is flattened into a ribbon shape and extends linearly from the proximal end to the distal end 114 of the end portion 116 of the core 102.
[0024]
[0032] In other embodiments, the end portion 116 may be configured to reduce the compressive force delivered to the distal end of the guidewire device 100. Specifically, the core 102 may have a bent and / or curved configuration such that the total length of the material forming the end portion 116 (i.e., the length when the end portion 116 is "stretched") is longer than the straight-line distance between the proximal and distal ends of the end portion 116.
[0025]
[0033] Figures 3B and 3C show the available configurations of the end portion 116. Figure 3B shows a curved end portion 116, and Figure 3C shows an end portion 116 bent along a line traversing the longitudinal axis of the device 100 to form multiple folds.
[0026]
[0034] These configurations encourage the distal end of the guidewire device 100 to bend and / or flex the terminal portion 116 when it is pushed against obstacles such as intravascular tissue as a result of the guidewire device pushing along the patient's vascular system. The bent or curved terminal portion 116 allows the distal portion of the core to elastically store compressive energy in the terminal portion 116 rather than deforming the tip of the guidewire device 100. Thus, such configurations help maintain the preferred shape of the tip of the guidewire device 100.
[0027]
[0035] Figure 3D shows another configuration of the terminal portion 116. In this embodiment, the terminal portion 116 includes, in order from proximal to distal, a wide portion 113, a tapered portion 115, and a narrow portion 117. The wide portion 113 has a width "W W "The width of the narrow section is 117" N It is larger than . The flattened end portion 116 is moldable and, in some embodiments, serves as the main moldable portion of the core. The “double flattened configuration” shown in Figure 3D advantageously provides a structure for molding (particularly from the wide portion 113) and also creates an intentional stress point prone to buckling due to the transition between the wide portion 113 and the narrow portion 117.
[0028]
[0036] The end portion 116 in Figure 3D may have a circular cross-section or a cross-section of a different shape, but is preferably formed in the shape of a flat ribbon with a rectangular or oval cross-section. The end portion 116 has a length "L" that includes the distance from the proximal end of the wide portion 113 to the distal end of the narrow portion 117. The length "L" of the end portion 116 may be about 0.5 cm to about 3 cm, or about 0.75 cm to about 2 cm, or may extend to about 1 cm, or may extend within a range with any two of the above values as endpoints.
[0029]
[0037] The tapered portion 115 is positioned within the terminal portion 116 such that its center is offset from the center point along the proximal-distal axis of the device within the length "L" of the terminal portion 116. In other words, the plane 119, which is oriented perpendicular to the proximal-distal axis of the core passing through the center of the tapered portion 115, does not intersect with the center point on the proximal-distal axis of the core that is midway between the proximal end of the wide portion 113 and the distal end of the narrow portion 117.
[0030]
[0038] Positioning the tapered section 115 off-center from the end section 116 increases the likelihood of buckling at the tapered section 115 when subjected to a given force. The off-center configuration reduces the amount of force required to induce buckling of the end section. That is, the axial force required to cause buckling in an off-center section of an elongated member is smaller than the axial force required to cause buckling in a similar elongated member at its center, thus reducing the likelihood of transmitting enough force into the patient's vascular system to permanently deform the tip of the molded guidewire or damage intravascular tissue.
[0031]
[0039] The wide portion 113 and the narrow portion 117 have different lengths so that the tapered portion 115 is offset from the center within the end portion 116 and securely positioned. The narrow portion 117 may be longer or shorter than the wide portion 113. Preferably, the wide portion 113 is longer than the narrow portion 117. A configuration with a relatively long wide portion 113 can provide effective moldability while ensuring sufficient length of the narrow portion 117 to reduce the force required for buckling.
[0032]
[0040] The narrow portion 117 may extend to a length "L" of the end portion 116, which preferably has a length of at least 5 mm, preferably from about 10% to less than 50%. Conversely, the wide portion 113 may extend to a length "L" of the end portion 116, preferably from more than 50% to less than 90%. The end portion 116 having the above configuration is beneficial in that it is easy to maintain the formed guide wire tip.
[0033] Characteristics of an example tube
[0041] Figure 4 shows the distal end of an exemplary guidewire device 100. The distal portion of the outer tube 106 may be joined to the core 102 at a distal attachment point 118 located proximal to the end portion 116. The distal end 114 of the core 102 may remain unjoined. This joining configuration allows the end portion 116 to bend and deflect within the annular space of the outer tube 106 when a force is applied to the distal end 114 of the core 102.
[0034]
[0042] When the distal end of the guidewire device 100 comes into contact with intravascular tissue, the compressive energy generated in the guidewire device (as a result of the technical operation of the device 100) may also be accumulated in the terminal portion 116 as it bends and flexes. This configuration allows the terminal portion 116 to elastically store compressive energy rather than deforming the tip of the guidewire device 100, thus preventing deformation of the guidewire tip which is shaped to effectively guide and manipulate the contour of the patient's vascular system. The independently bending and flexing terminal portion also helps to prevent the transmission of relatively large forces from the guidewire to the patient's vascular system, thereby reducing the potential for harm and damage to tissue resulting from the application of compressive forces.
[0035]
[0043] The following embodiments describe an outer tube 106 in a guidewire device 100 configured to increase flexibility and / or, conversely, to produce or eliminate a preferred bending direction. Figure 5 shows an exemplary embodiment of the outer tube 106 including a corrugated ring portion 120. The corrugated ring portion 120 includes a circumferentially extending ring 112 whose circumference changes axially along the device 100.
[0036]
[0044] Each ring 112 may vary axially at the same rate as other adjacent rings 112 positioned proximal and / or distally, so that the shape of each ring 112 conforms to the shape of the other adjacent rings 112. Furthermore, the corrugated ring section 120 may include a cut pattern of one beam, two beams, or three beams. The continuous beams 110 may be offset by 90 degrees in the rotational direction, particularly in the one-beam or two-beam cut pattern embodiment. These configurations allow the outer tube 106 to bend while more space is eliminated between the rings 112 on the side of the tube 106 in the bending direction. In this way, the rings 112 are positioned closely together on the same side as the bending direction of the outer tube 106, allowing the outer tube 106 to bend faster and increasing the flexibility of the device 100.
[0037]
[0045] The wavy ring portion 120 may be formed to include a sinusoidal shape along its circumference, thereby forming a wavy pattern. The line extending along the circumference of the ring 112 may include one or more inflection points (i.e., points along the line where a change in the direction of curvature occurs).
[0038]
[0046] The outer tube 106 may include a nonlinear beam section 122 to further enhance the flexibility of the device 100. The beam 110 extending axially in the nonlinear beam section is configured such that the line passing through the center of the beam 110 (i.e., the center line) is not linear. In the case of a beam 110 that crosses a pair of rings 112 spaced at a specific distance apart, the nonlinear beam 110 has a longer effective length than the linear beam 110. Therefore, the nonlinear beam 110 exhibits higher flexibility than the linear beam 110 because it has a larger deflection and bending length.
[0039]
[0047] For example, the beam 110 may be formed in an "S" shape such that the centerline of the beam 110 includes an inflection point, as shown in Figure 6. Furthermore, the beam 110 may be formed in a "C" shape such that the centerline of the beam 100 includes a turning point (i.e., a point along the line that indicates a local maximum or minimum value where the line changes direction), as shown in Figure 7. The nonlinear beam section 122 can be arranged in a cut configuration of one beam, two beams, or three beams.
[0040]
[0048] The "S" and "C" shaped beams 110 help to form or eliminate a favorable bending direction. The circumferentially extending ring 112 may have a greater tendency to tilt in the direction of less material support from the beam 110. Compared to a linear beam 110, the "S" and "C" shaped beams 110 distribute material from one side of the beam 110 to the other at both ends of the beam 110. This causes the ring 112 to tilt more in the direction of relatively less material, helping to form or eliminate a favorable bending direction.
[0041]
[0049] Other embodiments of the outer tube 106 may include geometry to induce bending or buckling in a preferred orientation. Figure 8 shows an exemplary embodiment of the outer tube 106 including a buckling portion 124. The buckling portion 124 is proximal to a first portion 126 and distal to a second portion 128. The first portion 126 includes a plurality of axially extending beams 110 arranged in a first pattern with a rotational offset in a first direction. The second portion 128 includes a plurality of axially extending beams 110 arranged in a second pattern with a rotational offset in a second direction.
[0042]
[0050] The beam 110 of the buckling section 124 may be positioned on one side of the outer tube 106 with respect to the longitudinal axis of the outer tube 106. The buckling section 124 may include one beam 110 or more consecutive beams 110, such as two, three, or more consecutive beams 110. The configuration of the first section 126, the second section 128, and the beam 110 within the buckling section 124 helps to define the bending direction of the tube 106 when buckling occurs, but the bending direction is opposite to that of the beam 110 of the buckling section 124.
[0043]
[0051] The first section 126 and the second section 128 may include a linear pattern in which the continuous beams 110 are offset by a fixed amount in the rotational direction, as shown in Figure 8. Alternatively, the first section 126 and the second section 128 may include a pattern in which the rotational offset of the continuous beams 110 increases distally along the outer tube 106, or a pattern in which the rotational offset of the continuous beams 110 decreases distally along the outer tube 106, such as a pattern in which the rotational offset of the continuous beams 110 is offset by an amount that changes the continuous beams 110. Furthermore, the amount of rotational offset between the continuous beams 110 in the linear pattern may differ in the first section 126 compared to the second section 128. Similarly, the rotational offset rate of the nonlinear pattern may differ in the first section 126 compared to the second section 128.
[0044]
[0052] Other embodiments of the outer tube 106 may include an asymmetrical section. Exemplary embodiments of the asymmetrical section are shown in Figures 9A to 11B. Within the asymmetrical section, an axially extending beam 110 is positioned on one side of the outer tube 106 with respect to a first plane (see Figure 9D) that includes the longitudinal axis and extends through the center of the outer tube 106. The arrangement of the beam 110 in the asymmetrical section can create a preferred bending direction toward the side surface of the outer tube 106 with respect to the first plane containing the beam 110.
[0045]
[0053] The beams 110 in the asymmetrical section are arranged such that pairs of consecutive beams 110 are not aligned in the rotational direction. Specifically, the centerline passing through the center of each beam 110 is offset in the rotational direction between the proximal and distal pairs of beams 110.
[0046]
[0054] The asymmetrical beams 110 may be arranged in a single-beam pattern, such that continuous beams 110 are alternately arranged on both sides of a second plane, the second plane being perpendicular to the first plane and including a longitudinal axis (see Figure 9D). In such an arrangement, each pair of continuous beams 110 may be alternately offset on both sides of the second plane.
[0047]
[0055] Figures 9A to 9D show the asymmetrical section of the outer tube 106, where the beams 110 are arranged adjacent to the second plane, and the continuous beams 110 are positioned alternately on both sides of the second plane. Lines 1'-1' and 2'-2' represent the side shapes of the first and second planes. Figure 9A shows a front view of the outer tube 106, and Figure 9B shows a rear view. Figure 9C shows a side view of the asymmetrical section where all beams 110 are arranged on one side of the outer tube 106 with respect to the first plane. Figure 9D shows a perspective view of the asymmetrical section where the continuous beams 110 are arranged alternately adjacent to the second plane.
[0048]
[0056] The beams 110 may be arranged alternately at a fixed distance from the second plane. Figures 10A and 10B show an arrangement in which the beams 110 are further separated from the second plane compared to the configuration in Figures 9A to 9D. Figures 11A and 11B show an additional arrangement in which the asymmetric beams 110 may intersect the second plane. The beams 110 may be arranged so that each beam 110 intersects the second plane, but the centerlines of each consecutive beam 110 are alternately offset in the rotational direction from the second plane.
[0049]
[0057] The flexibility of the distal portion of the outer tube 106 can be optimized by reducing the width of the beam 110 relative to the outer diameter of the tube 106. Specifically, if the ratio of the outer diameter of the tube 106 to the width of the axially extending beam 110 at the distal portion of the outer tube 106 is approximately 11.3 or greater, the flexibility of the distal portion of the outer tube 106 may increase.
[0050] Further terms and definitions
[0058] While specific embodiments of this disclosure have been described in detail with reference to certain configurations, parameters, components, elements, etc., the descriptions are illustrative and should not be construed as limiting the scope of the claimed invention.
[0051]
[0059] Furthermore, it should be understood that, for any given element of the components of the described embodiments, any possible substitutes listed for that element or component may be used individually or in combination with each other, unless otherwise implicitly or explicitly stated.
[0052]
[0060] Furthermore, unless otherwise indicated, numerical values used in the specification and claims to represent quantities, components, distances, or other measured values are understood to be optionally modified by the term “about” or its synonyms. When the terms “about,” “approximately,” “substantially,” or similar are used in conjunction with a stated quantity, value, or condition, they may be understood to mean a quantity, value, or condition that deviates by less than 20%, less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated quantity, value, or condition. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be interpreted in light of the reported significant number of decimal places and by applying common rounding techniques.
[0053]
[0061] While the term "core" can be interpreted as referring to a solid wire structure, the terminology used in this specification also includes internal components that do not necessarily require a solid structure.
[0054]
[0062] Any headings and subheadings used herein are for organizational purposes only and are not intended to be used to limit the scope of the description or claims.
[0055]
[0063] It should also be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” do not exclude plural referents unless the context explicitly states otherwise. Thus, an embodiment referring to a single referent (e.g., “widget”) may include two or more such referents.
[0056]
[0064] It will be recognized that embodiments described herein may include properties and / or features (e.g., materials, components, members, elements, parts, and / or parts) described in one or more distinct embodiments, and are not necessarily strictly limited to the features explicitly described for that particular embodiment. Accordingly, various features of a given embodiment may be combined with and / or incorporated into other embodiments of the Disclosure. Therefore, the disclosure of certain features for a particular embodiment of the Disclosure should not be construed as limiting the application or inclusion of such features to that particular embodiment. Rather, it will be recognized that other embodiments may also include such features.
Claims
1. It is an intravascular device, The core comprises a proximal portion and a distal portion, wherein the distal portion includes a terminal portion adjacent to the proximal end of the core. An intravascular device in which the total length of the material forming the terminal portion is greater than the straight-line distance between the proximal and distal ends of the terminal portion.
2. The intravascular device according to claim 1, wherein the terminal portion includes one or more folds.
3. The intravascular device according to claim 2, wherein the terminal portion is bent along one or more lines extending across the longitudinal axis of the core to form one or more folds in the terminal portion.
4. The intravascular device according to claim 1, wherein the terminal portion is curved.
5. A tube having a proximal portion and a distal portion, further comprising the tube, wherein the distal portion of the core is connected to the core such that it passes through the tube and is surrounded by the tube, The intravascular device according to any one of claims 1 to 4, wherein the distal portion of the tube is coupled to the distal portion of the core at a distal attachment point disposed proximal to the distal end of the core.
6. The intravascular device according to claim 5, wherein the distal mounting point is located approximately 1 cm to 5 cm from the distal end of the core.
7. The intravascular device according to claim 5 or 6, wherein the distal portion of the core extending from the distal mounting point to the distal end of the core is flattened into a ribbon-like shape having a flat, rectangular, or oval cross-section.
8. The aforementioned pipe is The wall and the internal lumen, A plurality of openings extending through the wall and exposing the lumen, the plurality of openings defining a plurality of axially extending beams and a plurality of circumferentially extending rings, The intravascular device according to any one of claims 5 to 8, comprising a wavy ring portion, wherein each ring of the wavy ring portion has a circumference that changes axially along the longitudinal axis of the device.
9. The intravascular device according to claim 8, wherein at least one of the rings in the wavy ring portion has a circumference including a sinusoidal wave pattern along the longitudinal axis of the device.
10. The intravascular device according to claim 8, wherein the line tracing the circumference of at least one ring in the wavy ring portion includes a plurality of inflection points.
11. The intravascular device according to any one of claims 8 to 10, wherein the tube includes a nonlinear beam section, and each beam of the nonlinear beam section extends such that the center line passing through the center of the beam is not linear.
12. The intravascular device according to claim 11, wherein the center line of at least one beam takes an "S" shape such that the center line includes an inflection point.
13. The intravascular device according to claim 11, wherein the center line of at least one beam takes the form of a "C" shape such that the center line includes a turning point.
14. The aforementioned pipe is A first portion comprising a plurality of axially extending beams arranged in a first pattern having a rotational offset in a first direction, A second portion comprising a plurality of axially extending beams arranged in a second pattern having a rotational offset in the second direction opposite to the rotational offset in the first direction, The intravascular device according to any one of claims 8 to 13, further comprising a buckling portion formed between the first portion and the second portion.
15. The apparatus according to claim 14, wherein the first portion of the pipe is disposed adjacent to the second portion of the pipe.
16. The apparatus according to claim 14, wherein the rotational offset of the first pattern is not equal to the rotational offset of the second pattern.
17. The intravascular device according to any one of claims 8 to 16, wherein the tube further comprises an asymmetric portion in which the beam is disposed on one side of the tube with respect to a first plane including the longitudinal axis of the tube, and in the asymmetric portion a pair of continuous beams is not aligned in the circumferential direction.
18. The apparatus according to claim 17, wherein the beams of the asymmetric portion are arranged along the length of the tube to form a non-helical and non-linearly distributed cut pattern.
19. The apparatus according to claim 17, wherein the beams of the asymmetrical portion are arranged in a single-beam pattern.
20. The apparatus according to claim 19, wherein the beams of the asymmetrical portion are arranged on both sides of a second plane, the second plane includes the longitudinal axis and is perpendicular to the first plane, and the plurality of continuous beams are alternately arranged on both sides of the second plane.
21. The apparatus according to claim 20, wherein the edges of each beam in the asymmetric portion are arranged adjacent to the second plane.
22. The apparatus according to claim 20, wherein each beam is offset from the second plane such that a space is left between the beam and the second plane.
23. The apparatus according to claim 20, wherein each beam intersects the second plane in a state in which the respective centerlines of each beam are not aligned in the rotational direction.
24. The intravascular device according to any one of claims 8 to 23, wherein the tube further comprises a narrow beam section in which the ratio of the outer diameter of the tube to the width of the beam is 11.3 or more.
25. It is an intravascular device, A core having a proximal and distal portion, A tube having a proximal portion and a distal portion, wherein the distal portion of the core is connected to the core such that it passes through the tube and is surrounded by the tube, An intravascular device wherein the distal portion of the tube is connected to the distal portion of the core at a distal attachment point located proximal to the distal end of the core.
26. The intravascular device according to claim 25, wherein the distal mounting point is located approximately 1 cm to 5 cm from the distal end of the core.
27. The intravascular device according to claim 25 or 26, wherein the distal portion of the core extending from the distal mounting point to the distal end of the core is flattened into a ribbon-like shape having a flat, rectangular, or oval cross-section.
28. The aforementioned pipe is The wall and the internal lumen, A plurality of openings extending through the wall and exposing the lumen, the plurality of openings defining a plurality of axially extending beams and a plurality of circumferentially extending rings, The intravascular device according to any one of claims 25 to 27, comprising a wavy ring portion, wherein each ring of the wavy ring portion has a circumference that changes axially along the longitudinal axis of the device.
29. The intravascular device according to claim 28, wherein at least one of the rings in the wavy ring portion has a circumference including a sinusoidal pattern along the longitudinal axis of the device.
30. The intravascular device according to claim 28, wherein the line tracing the circumference of at least one ring in the wavy ring portion includes a plurality of inflection points.
31. The intravascular device according to any one of claims 28 to 30, wherein the tube includes a nonlinear beam section, and each beam of the nonlinear beam section extends such that the center line passing through the center of the beam is not linear.
32. The intravascular device according to claim 31, wherein the center line of any one beam takes an "S" shape such that the center line includes an inflection point.
33. The intravascular device according to claim 31, wherein the center line of any one beam takes the form of a "C" shape such that the center line includes a turning point.
34. The aforementioned pipe is A first portion comprising a plurality of axially extending beams arranged in a first pattern having a rotational offset in a first direction, A second portion comprising a plurality of axially extending beams arranged in a second pattern having a rotational offset in the second direction opposite to the rotational offset in the first direction, The intravascular device according to any one of claims 28 to 33, further comprising a buckling portion formed between the first portion and the second portion.
35. The apparatus according to claim 34, wherein the first portion of the pipe is disposed adjacent to the second portion of the pipe.
36. The apparatus according to claim 34, wherein the rotational offset of the first pattern is not equal to the rotational offset of the second pattern.
37. The intravascular device according to any one of claims 8 to 36, wherein the tube further comprises an asymmetric portion in which the beam is disposed on one side of the tube with respect to a first plane including the longitudinal axis of the tube, wherein a pair of continuous beams in the asymmetric portion are not aligned in the rotational direction.
38. The apparatus according to claim 37, wherein the beams of the asymmetric portion are arranged along the length of the tube to form a non-helical and non-linearly distributed cut pattern.
39. The apparatus according to claim 37, wherein the beams in the asymmetrical portion are arranged in a single-beam pattern.
40. The apparatus according to claim 39, wherein the beams of the asymmetrical portion are arranged on both sides of a second plane, the second plane includes the longitudinal axis and is perpendicular to the first plane, and the plurality of continuous beams are alternately arranged on both sides of the second plane.
41. The apparatus according to claim 40, wherein the edges of each beam in the asymmetric portion are arranged adjacent to the second plane.
42. The apparatus according to claim 40, wherein each beam is offset from the second plane such that a space is left between the beam and the second plane.
43. The apparatus according to claim 40, wherein each beam intersects the second plane in a state in which the respective centerlines of each beam are not aligned in the rotational direction.
44. The intravascular device according to any one of claims 28 to 43, wherein the tube further comprises a narrow beam section in which the ratio of the outer diameter of the tube to the width of the beam is 11.3 or more.
45. It is an interventional device, An elongated member having a wall and an internal lumen, comprising a plurality of openings extending through the wall and exposing the lumen, wherein the plurality of openings define a plurality of axially extending beams and a plurality of circumferentially extending rings, the elongated member comprises The aforementioned elongated member includes a wavy ring portion, The rings of the wavy ring portion each include a circumference that changes axially along the longitudinal axis of the device, and are an interventional device.
46. The apparatus according to claim 45, wherein at least one of the rings in the corrugated ring portion includes a circumference having a sinusoidal pattern along the longitudinal axis of the apparatus.
47. The apparatus according to claim 45, wherein the line tracing the circumference of at least one ring in the wavy ring portion includes a plurality of inflection points.
48. The interventional device according to any one of claims 45 to 47, wherein the elongated member includes a nonlinear beam section, and each beam of the nonlinear beam section extends such that the center line passing through the center of the beam is not linear.
49. The apparatus according to claim 48, wherein the center line of any one beam takes an "S" shape such that the center line includes an inflection point.
50. The apparatus according to claim 48, wherein the center line of any one beam takes the form of a "C" shape such that the center line includes a turning point.
51. The aforementioned elongated member is A first portion comprising a plurality of axially extending beams arranged in a first pattern having a rotational offset in a first direction, A second portion comprising a plurality of axially extending beams arranged in a second pattern having a rotational offset in the second direction opposite to the rotational offset in the first direction, The interventional device according to any one of claims 45 to 50, further comprising a buckling portion formed between the first portion and the second portion.
52. The apparatus according to claim 51, wherein the first portion of the elongated member is disposed adjacent to the second portion of the elongated member.
53. The apparatus according to claim 51, wherein the rotational offset of the first pattern is not equal to the rotational offset of the second pattern.
54. The interventional device according to any one of claims 45 to 53, wherein the elongated member further comprises an asymmetric portion on one side of the elongated member with respect to a first plane including the longitudinal axis of the elongated member, wherein the asymmetric portion is not aligned in the rotational direction with respect to a pair of continuous beams in the asymmetric portion.
55. The apparatus according to claim 54, wherein the beam of the asymmetric portion is arranged along the length of the elongated member to form a non-helical and non-linearly distributed cut pattern.
56. The apparatus according to claim 54, wherein the beams of the asymmetrical portion are arranged in a single-beam pattern.
57. The apparatus according to claim 56, wherein the beams of the asymmetrical portion are arranged on both sides of a second plane, the second plane includes the longitudinal axis and is perpendicular to the first plane, and the plurality of continuous beams are alternately arranged on both sides of the second plane.
58. The apparatus according to claim 57, wherein the edges of each beam in the asymmetric portion are arranged adjacent to the second plane.
59. The apparatus according to claim 57, wherein each beam is offset from the second plane such that a space is left between the beam and the second plane.
60. The apparatus according to claim 57, wherein each beam intersects the second plane in a state in which the respective centerlines of each beam are not aligned in the rotational direction.
61. The interventional device according to any one of claims 45 to 60, wherein the elongated member further comprises a thin beam portion in which the ratio of the outer diameter of the elongated member to the width of the beam is 11.3 or more.
62. It is an interventional device, An elongated member having a wall and an internal lumen, comprising a plurality of openings extending through the wall and exposing the lumen, wherein the plurality of openings define a plurality of axially extending beams and a plurality of circumferentially extending rings, the elongated member comprises The elongated member includes a nonlinear beam portion, An interventional device in which each beam of the nonlinear beam section extends such that the center line passing through the center of the beam is not linear.
63. The apparatus according to claim 62, wherein the center line of any one beam takes an "S" shape such that the center line includes an inflection point.
64. The apparatus according to claim 62, wherein the center line of any one beam takes the form of a "C" shape such that the center line includes a turning point.
65. The aforementioned elongated member is A first portion comprising a plurality of axially extending beams arranged in a first pattern having a rotational offset in a first direction, A second portion comprising a plurality of axially extending beams arranged in a second pattern having a rotational offset in the second direction opposite to the rotational offset in the first direction, The interventional device according to any one of claims 62 to 64, further comprising a buckling portion formed between the first portion and the second portion.
66. The apparatus according to claim 65, wherein the first portion of the elongated member is disposed adjacent to the second portion of the elongated member.
67. The apparatus according to claim 65, wherein the rotational offset of the first pattern is not equal to the rotational offset of the second pattern.
68. The interventional device according to any one of claims 62 to 67, wherein the elongated member further comprises an asymmetric portion on one side of the elongated member with respect to a first plane including the longitudinal axis of the elongated member, wherein the asymmetric portion is such that a pair of continuous beams in the asymmetric portion are not aligned in the rotational direction.
69. The apparatus according to claim 68, wherein the beam of the asymmetric portion is arranged along the length of the elongated member to form a non-helical and non-linearly distributed cut pattern.
70. The apparatus according to claim 68, wherein the beams in the asymmetrical portion are arranged in a single-beam pattern.
71. The apparatus according to claim 70, wherein the beams of the asymmetrical portion are arranged on both sides of a second plane, the second plane includes the longitudinal axis and is perpendicular to the first plane, and the plurality of continuous beams are alternately arranged on both sides of the second plane.
72. The apparatus according to claim 71, wherein the edges of each beam in the asymmetric portion are arranged adjacent to the second plane.
73. The apparatus according to claim 71, wherein each beam is offset from the second plane such that a space is left between the beam and the second plane.
74. The apparatus according to claim 71, wherein each beam intersects the second plane in a state in which the respective centerlines of each beam are not aligned in the rotational direction.
75. The interventional device according to any one of claims 62 to 74, wherein the elongated member further comprises a thin beam portion in which the ratio of the outer diameter of the elongated member to the width of the beam is 11.3 or more.
76. It is an interventional device, An elongated member having a wall and an internal lumen, comprising a plurality of openings extending through the wall and exposing the lumen, wherein the plurality of openings define a plurality of axially extending beams and a plurality of circumferentially extending rings, the elongated member comprises The first portion of the elongated member includes a plurality of axially extending beams arranged in a first pattern having a rotational offset in the first direction, The second portion of the elongated member includes a plurality of axially extending beams arranged in a second pattern having a rotational offset in the second direction opposite to the rotational offset in the first direction, An interventional device in which a buckling portion is formed between the first portion and the second portion.
77. The apparatus according to claim 76, wherein the first portion of the elongated member is disposed adjacent to the second portion of the elongated member.
78. The apparatus according to claim 76, wherein the rotational offset of the first pattern is not equal to the rotational offset of the second pattern.
79. The interventional device according to any one of claims 76 to 78, wherein the elongated member further comprises an asymmetric portion on one side of the elongated member with respect to a first plane including the longitudinal axis of the elongated member, wherein the asymmetric portion is such that a pair of continuous beams in the asymmetric portion are not aligned in the rotational direction.
80. The apparatus according to claim 79, wherein the beam of the asymmetric portion is arranged along the length of the elongated member to form a non-helical and non-linearly distributed cut pattern.
81. The apparatus according to claim 79, wherein the beams in the asymmetrical portion are arranged in a single-beam pattern.
82. The apparatus according to claim 81, wherein the beams of the asymmetrical portion are arranged on both sides of a second plane, the second plane includes the longitudinal axis and is perpendicular to the first plane, and the plurality of continuous beams are alternately arranged on both sides of the second plane.
83. The apparatus according to claim 82, wherein the edges of each beam in the asymmetric portion are arranged adjacent to the second plane.
84. The apparatus according to claim 82, wherein each beam is offset from the second plane such that a space is left between the beam and the second plane.
85. The apparatus according to claim 82, wherein each beam intersects the second plane in a state in which the respective centerlines of each beam are not aligned in the rotational direction.
86. The interventional device according to any one of claims 76 to 85, wherein the elongated member further comprises a thin beam portion in which the ratio of the outer diameter of the elongated member to the width of the beam is 11.3 or more.
87. It is an interventional device, An elongated member having a wall and an internal lumen, comprising a plurality of openings extending through the wall and exposing the lumen, wherein the plurality of openings define a plurality of axially extending beams and a plurality of circumferentially extending rings, the elongated member comprises The elongated member has an asymmetrical portion, In the asymmetric portion, the beam is arranged on one side of the elongated member with respect to a first plane including the longitudinal axis of the elongated member, and the pair of continuous beams in the asymmetric portion are not aligned in the rotational direction, an interventional device.
88. The apparatus according to claim 87, wherein the beam of the asymmetric portion is arranged along the length of the elongated member to form a non-helical and non-linearly distributed cut pattern.
89. The apparatus according to claim 87, wherein the beams in the asymmetrical portion are arranged in a single-beam pattern.
90. The apparatus according to claim 89, wherein the beams of the asymmetrical portion are arranged on both sides of a second plane, the second plane includes the longitudinal axis and is perpendicular to the first plane, and the plurality of continuous beams are alternately arranged on both sides of the second plane.
91. The apparatus according to claim 90, wherein the edges of each beam in the asymmetric portion are arranged adjacent to the second plane.
92. The apparatus according to claim 90, wherein each beam is offset from the second plane such that a space is left between the beam and the second plane.
93. The apparatus according to claim 90, wherein each beam intersects the second plane in a state in which the respective centerlines of each beam are not aligned in the rotational direction.
94. The interventional device according to any one of claims 87 to 93, wherein the elongated member further comprises a thin beam portion in which the ratio of the outer diameter of the elongated member to the width of the beam is 11.3 or more.
95. It is an interventional device, An elongated member having a wall and an internal lumen, comprising a plurality of openings extending through the wall and exposing the lumen, wherein the plurality of openings define a plurality of axially extending beams and a plurality of circumferentially extending rings, the elongated member comprises The aforementioned elongated member has a thin beam section, In the thin beam section, the ratio of the outer diameter of the elongated member to the width of the beam is 11.3 or more, an interventional device.
96. It is an intravascular device, A core comprising a terminal portion that is proximal to the distal end of the core, the terminal portion being The wide section and A tapered portion is connected to the distal end of the wide portion and has a width that tapers from proximal to distal, Including a narrow portion connected to the distal end of the aforementioned tip section, An intravascular device having a wider width than the width of the narrower portion.
97. The interventional device according to claim 96, wherein the narrow portion has a shorter length than the wide portion.
98. The interventional device according to claim 96 or 97, wherein the narrow portion has a length of 10% to less than 50% of the length of the end portion.
99. The interventional device according to any one of claims 96 to 98, wherein the terminal portion has a length of approximately 0.5 cm to approximately 3 cm, or approximately 0.75 cm to approximately 2 cm, or approximately 1 cm, or a length in the range having any two endpoints of the aforementioned values.