Guide wire having an enlarged, microfabricated distal section

Abstract

A guidewire is disclosed that includes a core wire and an outer tube into which a distal section of the core is inserted. The outer diameter of the tube is larger than the outer diameter of the proximal section of the core wire. The guidewire further includes a proximal coil and a radiopaque distal coil, each disposed over the distal section of the core. A bushing coil is disposed over the proximal coil and the distal coil. The proximal coil, the distal coil, and the bushing coil help fill the annular space between the core and the tube, thereby assisting in centering and aligning the core and the tube.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit and priority of U.S. Patent Application No. 17 / 154,777, filed on January 21, 2021, and U.S. Provisional Patent Application No. 62 / 965,005, filed on January 23, 2020, both entitled "Guidewire Having Enlarged, Micro - Fabricated Distal Section". Each of the applications mentioned above is hereby incorporated by reference in its entirety.

Background Art

[0002]

[0002] Guidewire devices are often used to guide or direct a catheter or other interventional device to a target anatomical location within a patient's body. Typically, a guidewire is threaded through and passed through a patient's vasculature to reach a target location, such as near or within the patient's heart or brain. X - ray imaging is commonly utilized to assist in navigating the guidewire to the target location. In many cases, the guidewire is placed within the body during the intervention, and the guidewire can be used to guide multiple catheters or other interventional devices to the target anatomical location.

[0003]

[0003] Guidewires are available in a variety of outer diameter sizes. Widely used sizes include, for example, 0.254 mm (0.010 inches), 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), and 0.965 mm (0.038 inches), although these widely used sizes may be smaller or larger in diameter. Since torque transmission is a function of diameter, guidewires with larger diameters generally have higher torque transmission (the ability to effectively transmit torque from the proximal portion of the wire to a more distal portion of the wire). On the other hand, guidewires with smaller diameters generally have higher flexibility.

[0004]

[0004] Catheters used with guidewires are sized to have an inner diameter that is somewhat larger than the outer diameter of the guidewire to allow the catheter to be positioned on and translated along the guidewire. The size difference between the guidewire and the catheter can affect the ability of the catheter to move along the guidewire. For example, as the annular space between the outer diameter of the guidewire and the inner diameter of the catheter increases, the potential amount of radial offset that the catheter may experience increases, and it may become more difficult to navigate the catheter along the guidewire. Excessive radial offset can result in a high risk that the distal end of the catheter will not smoothly follow the guidewire path and will become trapped in the patient's vasculature or other anatomical structures.

[0005]

[0005] Often, the size of the guide wire is selected to minimize the size of the annular space between the guide wire and a given catheter size required or desired for a particular procedure, and thus to suppress the types of problems described above. However, this approach has several challenges. For example, as the size of the guide wire increases, the stiffness of the guide wire also undesirably increases to a level that is potentially not desirable for initially placing the guide wire at the target treatment site. Further, there are known methods for improving the flexibility of the guide wire, such as reducing the diameter of the core wire, but these methods often sacrifice the torquability of the device.

SUMMARY OF THE INVENTION

[0006]

[0006] Accordingly, there is a need for a guide wire device that can be manufactured to have a relatively large outer diameter, at least in the distal section, such that the annular space between the guide wire and a catheter of a particular size is minimized and sufficient flexibility and sufficient torquability are provided along its length.

[0007]

[0007] From the following description of the embodiments, read in conjunction with the accompanying drawings and the appended claims, various objects, features, characteristics, and advantages of the present invention will become apparent and more readily appreciated, all of which form a part of this specification. In the drawings, like reference numerals may be used to designate corresponding or similar parts in the various figures. The various elements are not necessarily drawn to exact scale.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]

Figure 1

[0008] A diagram showing an embodiment of a guide wire device having a core and an outer tube that can utilize one or more of the components described herein.

Figure 2

[0009] FIG. is a diagram showing an exemplary embodiment of a guide wire device including a tube having an outer diameter larger than the outer diameter of the proximal section of the core.

Figure 3

[0010] FIG. 4 is a detailed view showing the distal section of the guide wire of FIG. 2 with the tube structure removed to better show the features below the device.

Figure 4

[0011] FIG. 8 is a detailed view showing the tube of the guide wire of FIG. 2.

Figure 5

[0012] FIG. 12 is a cross-sectional view showing the alignment of the beam of the one-beam section of the tube with respect to the flattened distal section of the core of the guide wire of FIG. 2.

Figure 6

[0013] FIG. 16 is a cross-sectional view showing the guide wire of FIG. 2, indicating that the outer diameter of the tube is larger than the outer diameter of the proximal section of the core.

Figure 7

[0009] Introduction

[0014] Figure 1 schematically shows the general components of a guidewire 100 that can utilize one or more features described in more detail below. The guidewire 100 shown has a core 102 and an outer tube 104. The core 102 has a distal section 103 (also referred to herein as the distal core 103) that extends into the outer tube 104 as shown. The distal core 103 may be tapered continuously or in one or more discrete sections, such that the more distal sections will have a smaller diameter and higher flexibility compared to the more proximal sections. In some embodiments, the most distal section of the core 102 may be flattened to have a shape like a ribbon with a flat cross-section, a rectangular cross-section, or an oval cross-section. For example, the distal core 103 may be ground to have a progressive taper such that it has a smaller radius at the distal end.

[0010]

[0015] The core 102 and the tube 104 are typically formed of different materials. For example, the tube 104 is preferably formed from a material having relatively high flexibility and elasticity, such as nitinol, whereas the core 102 may be formed from a material having relatively low flexibility and elasticity, such as stainless steel. It may be advantageous to form the core 102 from stainless steel (or other materials having an equivalent modulus of elasticity). The reason is that the distal tip can maintain its shape when selectively bent / shaped by the surgeon, and stainless steel provides a modulus of elasticity sufficient to achieve a more responsive translational movement. Currently, these materials are suitable, but in addition or alternatively, other suitable materials such as polymers or other metals / alloys may be utilized.

[0011]

[0016] The tube 104 is coupled to the core 102 (e.g., using adhesion, soldering, and / or welding) in a manner that beneficially enables torsional force to be transmitted from the core 102 to the tube 104 and thereby further transmitted distally by the tube 104. A medical grade adhesive or other suitable material may be used to couple the tube 104 to the core wire 102 to form a non-invasive covering at the distal end 110 of the device.

[0012]

[0017] The outer tube 104 can have a notch pattern that forms a fenestration 106 within the tube. The pattern of the fenestration 106 can be arranged and configured to provide the tube 104 with desired flexibility characteristics, such as promoting a preferred bending direction, reducing or eliminating a preferred bending direction, or incrementally improving flexibility along the longitudinal axis. Examples of notch patterns and other guidewire device features that can be utilized in the guidewire devices described herein are presented in detail in U.S. Patent Application Publication Nos. 2018 / 0193607, 2018 / 0071496, and 2020 / 0121308, each of which is incorporated herein by reference in its entirety.

[0013]

[0018] The proximal section of the guidewire device 100 (the portion extending proximally from the tube 104) extends proximally to a length necessary to provide a guidewire length sufficient to be delivered to the target anatomical region. The guidewire device 100 typically has a length in the range of about 50 cm to about 350 cm, and more generally has a length of about 200 cm, depending on the requirements of a particular application. The tube 104 can have a length in the range of about 5 cm to about 350 cm, and more generally can have a length in the range of about 15 cm to about 50 cm (such as about 25 cm to about 40 cm).

[0014]

[0019] The guide wire device 100 can have a diameter from about 0.254 mm (0.010 inches) to about 0.965 mm (0.038 inches). However, depending on the requirements of a particular application, larger or smaller sizes may be utilized. For example, certain embodiments can have an outer diameter size corresponding to standard guide wire 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), or other sizes typical for guide wire devices. The distal section 103 of the core 102 may taper to a diameter of about 0.51 mm (about 0.002 inches), or a diameter within the range of about 0.0254 to 1.27 mm (about 0.001 to 0.050 inches). In some embodiments, the distal tip may be flattened (e.g., having a rectangular cross-section) to further improve bending flexibility while minimizing the reduction in cross-sectional area required for tensile strength. In such embodiments, the cross-section can have dimensions such as, for example, about 0.0254 mm (0.001 inches) × 0.0762 mm (0.003 inches). In some embodiments, the tube 104 has a length within the range of about 3 cm to 350 cm.

[0015]

[0020] Additional features and details regarding the above-described components are explained in further detail below. The following examples are particularly beneficial in applications where the corresponding catheter is of a schematic size of about 0.0686 mm (0.027 inches) or greater, and thus the size of the annular space between the inner surface of the catheter and the outer surface of the guide wire is limited, yet the guide wire is beneficially of a size of about 0.610 mm (0.024 inches) or greater to allow relative movement between the inner surface of the catheter and the outer surface of the guide wire. In such an implementation, the guide wire described herein can provide a diameter in the distal section of the device sufficient to limit the annular space while maintaining effective torque capabilities and lateral flexibility. These sizes are not limiting, and the same features and details described below can be utilized with guide wires smaller or larger than 0.610 mm (0.024 inches). Improved guide wire device with an enlarged distal section

[0021] Figure 2 shows an example of a guide wire 200. Unless otherwise specified, the guide wire 200 can have any of the general features described above in relation to the guide wire 100. Here, like reference numerals indicate like parts. As shown, the guide wire 200 has a core 202 and an outer tube 204, with the distal section 203 of the core 202 inserted into the tube 204. The outer tube 204 has a plurality of windows 206. A polymer-based adhesive can form a non-traumatic distal tip 210.

[0016]

[0022] The core 202 is disposed proximal to the outer tube 204 and further has a proximal section 201 (also referred to herein as the proximal core 201) that is not inserted into the outer tube 204. The proximal core 201 can have a friction-reducing coating such as polytetrafluoroethylene (PTFE) and / or other suitable coating materials. The tube 204 can further have a coating, a suitable hydrophilic coating, and / or other suitable coating materials.

[0017]

[0023] Preferably, the outer diameter of the tube 204 is slightly larger than the outer diameter of the proximal core 201. In an exemplary embodiment, the proximal core 201 has an outer diameter of about 0.457 mm (0.018 inches), while the tube 204 has an outer diameter of about 0.610 mm (0.024 inches). However, other core sizes and / or tube sizes may be utilized. Preferably, the tube 204 has an outer diameter that is about 10% or more, preferably about 15% to about 80% or more, or more preferably about 20% to about 70% or more (such as about 25% or more to about 35% or more) of the outer diameter of the proximal core 201.

[0018]

[0024] This is further shown in the cross-sectional views of FIGS. 6 and 7. As shown, the outer diameter (D1) of the proximal core 201 is smaller than the outer diameter (D2) of the tube 204. The ratio of D2 to D1 can be, for example, from 1.1 to 3, more preferably from 1.15 to about 2, or about 1.2 to about 1.75.

[0019]

[0025] As mentioned above, the larger outer diameter of the tube 204 can be well adapted to a particular desired catheter size at the distal tip portion of the catheter, thereby reducing the size of the annular space between the guide wire and the catheter when the catheter is disposed on the guide wire. This is particularly beneficial in the more distal section of the guide wire that is more likely to be navigated through deeper and more tortuous portions of the patient's vasculature.

[0020]

[0026] However, increasing the diameter of the core 202 to accommodate a larger diameter of the tube 204 can impart an overly high stiffness to the core 202 for use in certain desired applications. Thus, by maintaining a small core 202 while increasing the size of the tube 204 relative to the core 202, it is possible to use a core 202 having a higher flexibility while obtaining the benefits of the larger tube 204 in the distal section of the guidewire 200.

[0021]

[0027] However, as will be described in more detail later, other problems can arise by providing a tube 204 having an outer diameter larger than the core 202. Specifically, due to the difference in diameter between the outer tube 204 and the distal core 203, the annular space between the outer surface of the distal core 203 and the inner surface of the tube 204 is enlarged. Because the tube 204 can have a higher flexibility than the distal core 203, when the wire advances through a curved portion, the distal core 203 can be positioned offset from the centerline of the tube 204. When the guidewire is moved through a vascular structure, such offsetting of the center can prevent rotational movement from being smoothly transmitted distally, whereby forces can build up and be suddenly released, causing the guidewire to move in a way that "snaps" and / or "whips" relative to a non-desired preferential rotational position. By thus interrupting the tactile sensation and rotational control of the guidewire, it can become more difficult for the surgeon to position the guidewire in the rotational direction as intended, thereby causing a delay in the intervention procedure, sub-optimal results, an inability to access the target position, or even a risk of tissue damage.

[0022]

[0028] The embodiments described herein advantageously provide additional features that assist in positioning the distal core 203 radially within the tube 204, even when the tube 204 has an outer diameter larger than the proximal core 201. One or more centering mechanisms may be included to advantageously reduce unwanted whip and / or snap of the guide wire (i.e., the centering mechanism can improve rotational control), thereby enabling the user to have better rotational control and improving the haptic handling of the guide wire.

[0023]

[0029] FIG. 3 shows an enlarged view of the distal section of the guide wire 200 with the tube 204 removed to better visualize the distal core 203 and some of the other underlying components. As shown, the core 202 has one or more transition zones 208, where the core 202 tapers to a smaller diameter. The distal end section 211 of the core 202 may be flattened. The one or more transition zones 208 may be discrete, and one or more sections of the core of substantially continuous outer diameter may be disposed therebetween. Alternatively, the distal core 203 may have a substantially continuous taper along all or most of its length.

[0024]

[0030] At the point where the proximal end of the tube 204 is attached to form a junction, a bushing 212 may be included. The bushing 212 can have an outer diameter that substantially conforms to the outer diameter of the proximal core 201. The bushing 212 may be formed from the same material as the tube 204 (e.g., nitinol). The bushing 212 enables better centering between the core 202 and the tube 204 and / or reduces the amount of adhesive required to bond separate components. Although shown here as a tube, the bushing 212 may have alternative geometries such as a coil, braid, grooved / notched tube, etc.

[0025]

[0031] As shown, the bushing 212 can further have a chamfered or beveled surface 214 on its proximal end to provide a smooth transition between different diameters. The distal end of the bushing 212 may also be chamfered or beveled. Even if the distal end of the bushing 212 is covered by the tube 204, providing chamfers / bevels at both ends of the bushing 212 can assist in manufacturing, eliminating the need to ensure the proper orientation of the bushing, and eliminating the possibility of incorrect orientation.

[0026]

[0032] The guide wire 200 shown has a proximal coil 216, a distal coil 218, and a bushing coil 220 positioned over the proximal coil 216 and the distal coil 218. The distal coil 218 is preferably formed of a radiopaque material such as a platinum group, gold, silver, palladium, iridium, osmium, tantalum, tungsten, bismuth, dysprosium, and gadolinium. Thus, the distal coil 218 preferably enables X-ray visualization of the distal end of the guide wire 200 during the procedure. The distal coil 218 can have a length of from about 0.5 cm to about 20 cm, or more generally from about 3 cm to about 15 cm (such as about 10 cm).

[0027]

[0033] The proximal coil 216 can be formed from a non-radiopaque material such as stainless steel, other suitable metals, suitable polymers, or other suitable materials. The proximal coil 216 can be attached to the distal core 203 at a point adjacent to or near the proximal end of the distal coil 218 and / or at any point along the length that coincides with the distal core 203 (most commonly, at or near each end of the proximal coil 216). The proximal coil 216 can have a length of from about 1 cm to 25 cm, or more commonly from about 3 cm to 20 cm (such as from about 5 cm to 15 cm). Technically, the distal coil 218 could be extended more proximally to replace the proximal coil 216. However, materials that function well as radiopaque markers (e.g., platinum) are relatively expensive. Further, by using them as a filling material to fill most of the annular space, when imaged under fluoroscopy, it may overly brighten the distal section of the guidewire 200, thus preventing the surgeon from visualizing other areas of interest. Thus, the proximal coil 216 is preferably separated from the distal coil 218 and formed from a material different from that of the distal coil 218.

[0028]

[0034] The proximal coil 216 and the distal coil 218 assist in filling a portion of the annular space between the distal core 203 and the tube 204. The coil embodiments shown herein are shown as having a wire with a circular cross-section, but it will be understood that other types of coils may be utilized. For example, the centering coil may be edge-wound and / or can have a ribbon cross-section, rectangular cross-section, elliptical cross-section, or other non-circular cross-sectional shape.

[0029]

[0035] The proximal coil 216 and the distal coil 218 assist in filling a portion of the annular space, but additional annular space remains, particularly when a somewhat larger tube 204 is utilized. The wire size of the proximal coil 216 and the distal coil 218 can be increased to fill additional space. However, excessive enlargement of the wire size can impart excessive rigidity to the device. Preferably, the wire size of the proximal coil 216 and the distal coil 218 is about 0.203 mm (0.008 inches) or less or about 0.152 mm (0.006 inches) or less, or more preferably about 0.102 mm (0.004 inches) or less (such as about 0.0508 mm (0.002 inches) or less).

[0030]

[0036] To assist in filling the remaining portion of the annular space, the guide wire 200 can have a bushing coil 220. The bushing coil 220 can be disposed over the proximal coil 216 and the distal coil 218. The bushing coil 220 can extend over the entirety of both the proximal coil 216 and the distal coil 218. Similar to the proximal coil 216 and the distal coil 218, the wire diameter of the bushing coil 220 is preferably limited. For example, the wire diameter of the bushing coil can be about 0.203 mm (0.008 inches) or less or about 0.152 mm (0.006 inches) or less, or more preferably about 0.102 mm (0.004 inches) or less (such as about 0.0508 mm (0.002 inches) or less). The bushing coil 220 can be formed of stainless steel and / or another suitable material such as another metal or polymer.

[0031]

[0037] By using the bushing coil 220 in addition to the proximal coil 216 and the distal coil 218, it helps to fill the annular space between the distal core 203 and the tube 204 without using coils of overly large size. This helps to maintain the distal core 203 centered within the tube 204, thereby preventing the undesirable effects of the above-described misalignment while minimizing the impact on the bending flexibility of the device.

[0032]

[0038] In some embodiments, the bushing coil 220 may substantially coincide with the proximal coil 216 and the distal coil 218. Alternatively, as shown, the bushing coil 220 can extend further proximally than the proximal coil 216. This allows the bushing coil 220 to further fill the annular space even in portions where it is not possible with the proximal coil 216. That is, due to the tapered profile of the distal core 203, even if a particular more proximal portion of the annular space does not conform to both the proximal coil 216 and the bushing coil 220, it can be filled by the more proximal extending portion of the bushing coil 220. The bushing coil 220 preferably extends along a significant portion of the length of the tube 204. For example, the bushing coil 220 can have a length of at least about 60% of the length of the tube 204, at least about 75% of the length of the tube 204, at least about 80% of the length of the tube 204, or at least about 85% of the length of the tube 204.

[0033]

[0039] In a preferred embodiment, the proximal coil 216 and the distal coil 218 are each wound in a first direction, while the bushing coil 220 is wound in the opposite second direction. This advantageously suppresses the interlocking and sticking of the bushing coil 220 with respect to the proximal coil 216 or the distal coil 218. Further, the bushing coil 220 can have a pitch different from the pitch of the proximal coil 216 or the distal coil 218 (e.g., a smaller pitch). For example, the proximal coil 216 and / or the distal coil 218 can have a pitch from about 0.0508 mm (0.002 inches) to about 0.203 mm (0.008 inches) or from about 0.0762 mm (0.003 inches) to about 0.178 mm (0.007 inches), while the bushing coil 220 can have a pitch from about 0.0254 mm (0.001 inches) to about 0.152 mm (0.006 inches) or from about 0.0508 mm (0.002 inches) to about 0.127 mm (0.005 inches).

[0034]

[0040] The proximal coil 216, the distal coil 218, and the bushing coil 220 are preferably configured to fill a significant portion of the volume of the annular space between the distal core 203 and the tube 204. For example, the proximal coil 216, the distal coil 218, and the bushing coil 220 can be configured to fill about 20% or more, about 35% or more, about 50% or more, about 60% or more, about 70% or more, about 80% or more, or up to about 90% or more of the volume of the annular space. Of course, other conventional guidewires can have junctions or bushings, and these junctions or bushings occupy a majority of the annular space at the particular portion of the guidewire where they are located. However, considering the entire length of the outer tube, these junctions and bushings fill only a relatively small portion of the volume of the entire annular section.

[0035]

[0041] The principles of the centering mechanisms described herein can be utilized with other structural configurations to provide beneficial centering effects. For example, the above-described embodiments describe various centering mechanisms comprising a core as an "inner member" and a microfabricated tube as an "outer member", but in addition or alternatively, other structures may be utilized as the outer member and / or inner member, along with one or more of the centering mechanisms described.

[0036]

[0042] For example, the inner member may be a wire (such as the ground core described above), a tube (e.g., a metal or polymer hypo tube or a microfabricated metal or polymer tube), a braid, or a coil. As a further example, the outer member may be a tube (e.g., a metal or polymer hypo tube or a microfabricated metal or polymer tube), a braid, a coil, or a polymer tube with a braid or coil assembled thereon. The centering mechanism can have a set of coils as described above, or in addition or alternatively, can have other structures for achieving the placement of the inner member centered within the outer member. For example, one or more of the coils 216, 218, 220 may be replaced with one or more tubes (e.g., a metal or polymer hypo tube or a microfabricated metal or polymer tube), a section of braid, or a set of stacked rings.

[0037]

[0043] Figure 4 shows the tube 204 separated from the core 202 and some of the other components of the device. The tube 204 extends between a proximal end 222 and a distal end 224. The apertures 206 formed within the tube 204 can be made according to various notch patterns. Preferably, the overall effect of the apertures provides a flexibility gradient across the tube 204, where the flexibility increases towards the distal end 224. Typically, higher flexibility can be obtained by removing a larger portion of the original material, such as by increasing the depth of the notches, reducing the space between adjacent notches, and / or reducing the number of axially extending beams 226 that connect the circumferentially extending rings 228 in each case.

[0038]

[0044] The illustrated embodiment can have, for example, a three-beam section 230 (where three beams connect each of the adjacent pairs of rings), with the three-beam section 230 transitioning to a two-beam section 232 (where two beams connect each of the adjacent pairs of rings), and the two-beam section 232 transitioning to a one-beam section 234 (where one beam connects each of the adjacent pairs of rings). Within each of these sections, further, the depth and / or spacing of the notches can be adjusted to provide a smooth flexibility gradient within and between the sections. For example, the two-beam section 232 can have a distance between notches that progressively decreases towards the distal end 224. The two-beam section 232 can then transition to the one-beam section 234, which itself can also have a distance between notches that progressively decreases towards the distal end 224.

[0039]

[0045] The one-beam section 234 can have a length of, for example, from about 0.5 cm to about 3 cm or from about 0.75 cm to about 2 cm. The two-beam section 232 can have a length of, for example, from about 4 cm to about 16 cm or from about 6 cm to about 12 cm. The three-beam section 230 can have a length of, for example, from about 12 cm to about 36 cm or from about 18 cm to about 30 cm. In other words, the three-beam section 230 can be about 2 to 5 times larger than the two-beam section 232, and the two-beam section 232 can be about 2 to 5 times larger than the one-beam section 234. By designing the tube 204 to have such a ratio of notches / beams sections, it has been found that in many applications, an effective balance of axial stiffness, lateral stiffness, and torsional stiffness can be obtained.

[0040]

[0046] The tube 204 can further have a most distal section 235 having a two-beam pattern. This section is relatively short, such as about 0.5 cm or less, about 0.25 cm or less, or about 0.15 cm or less. By providing a relatively short two-beam section at section 235, an additional surface area is obtained for applying an adhesive material at or near the distal end 224 of the tube 204 to be adhered, thereby making it possible to strengthen the bond between the distal end 224 and any internal components adhered thereto.

[0041]

[0047] Certain sections of the tube 204 can have notches that are offset in the rotational direction to avoid forming any suitable curved surface. For example, an angular offset can be applied after each notch or series of notches, such that the resulting overall pattern of the beams 226 within the tube 204 is not aligned to form a suitable curved surface.

[0042]

[0048] Other sections of the tube 204 can have a suitable bending surface. For example, the one-beam section 234 can be aligned as shown in FIG. 4, with each beam offset by approximately 180° from the previous beam. These beams can further be aligned with the bending surface of the flattened distal end section 211 of the core. FIG. 5 shows in cross-section how the beam 226 of the one-beam section 234 is preferably aligned in the same plane as the flattened wide section of the distal end section 211 of the core. Additional exemplary embodiments

[0049] The following embodiments include various combinations of features of the intravascular devices described herein. The embodiments described herein can include characteristics, features (e.g., components, members, elements, parts, and / or portions) described in other embodiments described herein. Thus, the various features of a given embodiment can be combined with, and / or incorporated into, other embodiments of the present disclosure. Accordingly, the disclosure of specific features with respect to a particular embodiment of the present disclosure should not be construed as limited to the application and inclusion of such features only to this particular embodiment. Rather, it will be recognized that other embodiments can also include these features.

[0043]

[0050] Embodiment 1: An intravascular device comprising a core having a proximal section and a distal section, and a grooved outer tube coupled to the core such that the distal section of the core passes into and is surrounded by the tube structure, the outer tube and the core defining an annular space between the inner surface of the outer tube and the distal section of the core disposed within the outer tube, the outer diameter of the outer tube being greater than the outer diameter of the proximal section of the core.

[0044]

[0051] Embodiment 2: A device according to Embodiment 1, further comprising a distal coil surrounding a part of the distal section of the core, a proximal coil disposed proximal to the distal coil and surrounding a part of the distal section of the core, and a bushing coil disposed on at least a part of one or both of the distal coil and the proximal coil, wherein the distal coil, the proximal coil, and the bushing coil fill at least a part of the annular space.

[0045]

[0052] Embodiment 3: A device according to Embodiment 2, wherein the distal coil has a radiopacity higher than that of stainless steel.

[0053] Embodiment 4: A device according to Embodiment 2 or 3, wherein the proximal coil has a radiopacity lower than that of the distal coil.

[0046]

[0054] Embodiment 5: A device according to any one of Embodiments 2 to 4, wherein the wire size of the distal coil is about 0.152 mm (0.006 inches) or less.

[0055] Embodiment 6: A device according to any one of Embodiments 2 to 5, wherein the wire size of the proximal coil is about 0.152 mm (0.006 inches) or less.

[0047]

[0056] Embodiment 7: A device according to any one of Embodiments 2 to 6, wherein the wire size of the bushing coil is about 0.152 mm (0.006 inches) or less.

[0057] Embodiment 8: A device according to any one of Embodiments 2 to 7, wherein the bushing coil extends further proximally than the proximal coil.

[0048]

[0058] Embodiment 9: A device according to any one of Embodiments 2 to 8, wherein the bushing coil has a length of at least about 60% of the length of the tube.

[0059] Embodiment 10: A device according to any one of Embodiments 2 to 9, wherein at least one of the proximal coil, the distal coil, and the bushing coil is wound in a direction opposite to that of the other coils.

[0049]

[0060] Embodiment 11: A device according to Embodiment 10, wherein the proximal coil and the distal coil are each wound in a first direction, while the bushing coil is wound in the opposite second direction.

[0050]

[0061] Embodiment 12: A device according to any one of Embodiments 2 to 11, wherein the bushing coil has a pitch smaller than the pitch of the proximal coil and / or the distal coil.

[0051]

[0062] Embodiment 13: A device according to any one of Embodiments 2 to 12, wherein the proximal coil, the distal coil, and the bushing coil fill 15% or more of the volume of the annular space.

[0052]

[0063] Embodiment 14: A device according to any one of Embodiments 1 to 13, wherein the outer diameter of the outer tube is about 10% or more larger than the outer diameter of the proximal section of the core.

[0064] Embodiment 15: A device according to any one of Embodiments 1 to 14, further comprising a bushing disposed at the proximal end of the outer tube to assist in coupling the outer tube to the core.

[0053]

[0065] Embodiment 16: A device according to Embodiment 15, wherein the bushing has a chamfered or beveled proximal edge.

[0066] Embodiment 17: A device according to any one of Embodiments 1 to 16, wherein the tube has at least one of a three-beam section, a two-beam section, and a one-beam section.

[0054]

[0067] Embodiment 18: A device according to any one of Embodiments 1 to 17, wherein the flattened distal section of the core has a suitable bending surface, and the suitable bending surface of the flattened distal section is aligned with the suitable bending surface of a portion of the tube on the flattened distal section.

[0055]

[0068] Embodiment 19: A core having a proximal section and a distal section, and a grooved outer tube coupled to the core such that the distal section of the core passes into and is surrounded by a tube structure, the outer tube and the core defining an annular space between the inner surface of the outer tube and the distal section of the core disposed within the outer tube, a distal coil surrounding a portion of the distal section of the core, a proximal coil disposed proximal to the distal coil and surrounding a portion of the distal section of the core, and a bushing coil disposed on at least a portion of one or both of the distal coil and the proximal coil, the distal coil, the proximal coil, and the bushing coil filling at least a portion of the annular space, an intravascular device.

[0056]

[0069] Embodiment 20: A core having a proximal section and a distal section, and a grooved outer tube coupled to the core such that the distal section of the core passes into and is surrounded by a tube structure, the outer tube and the core defining an annular space between the inner surface of the outer tube and the distal section of the core disposed within the outer tube, the outer diameter of the outer tube being larger than the outer diameter of the proximal section of the core, a distal coil surrounding a portion of the distal section of the core, a proximal coil disposed proximal to the distal coil and surrounding a portion of the distal section of the core, and a bushing coil disposed on the distal coil and the proximal coil, at least one of the proximal coil, the distal coil, and the bushing coil being wound in a direction opposite to that of the other coils, the distal coil, the proximal coil, and the bushing coil filling 15% or more of the volume of the annular space, an intravascular device. Conclusion

[0070] While specific configurations, parameters, components, elements, etc. have been described with reference to particular embodiments of the present disclosure, this description is illustrative and should not be construed as limiting the scope of the claimed invention.

[0057]

[0071] Furthermore, in any given element of the components of the described embodiments, any alternative of the possible alternatives listed for this element or component may generally be used, individually or in combination with each other, unless otherwise specified.

[0058]

[0072] In addition, unless otherwise specified, numerical values representing amounts, components, distances, or other measurements used in this specification and the claims are to be understood as optionally modified by "about" or its synonyms. When terms such as "about," "and," or "substantially" are used with the recited amounts, values, or conditions, amounts or conditions deviating by less than 20%, less than 10%, less than 5%, or less than 1% from the recited amounts, values, or conditions may be meant. Without attempting to limit the application of the doctrine of equivalents in the claims, at least each numerical parameter should be construed in light of the significant figures recited, by applying ordinary rounding techniques.

[0059]

[0073] Any headings and subheadings used in this specification are for the sole purpose of organization and are not intended to be used to limit the scope of this description or the claims.

[0060]

[0074] Note that the singular forms "a," "an," and "the" as used in this specification and the appended claims do not exclude a plurality of referents unless otherwise specified. Thus, for example, an embodiment referring to a singular referent (e.g., a small device) can also include two or more of this referent.

Claims

1. A core having a proximal section and a distal section, and a grooved outer tube coupled to the core such that the distal section of the core extends into a tube structure and is surrounded by the tube structure, the outer tube and the core defining an annular space between an inner surface of the outer tube and the distal section of the core disposed within the outer tube, the grooved outer tube and an intravascular device having an outer diameter of the outer tube greater than an outer diameter of the proximal section of the core, the intravascular device a distal coil surrounding a portion of the distal section of the core, a proximal coil disposed proximal to the distal coil and surrounding a portion of the distal section of the core, and a bussing coil disposed on at least a portion of one or both of the distal coil and the proximal coil further comprising, the distal coil, the proximal coil, and the bussing coil filling at least a portion of the annular space, an intravascular device in which at least one of the proximal coil, the distal coil, and the bussing coil is wound in a direction opposite to that of the other coils.

2. The device of claim 1, wherein the distal coil has a radiopacity higher than that of stainless steel.

3. The device of claim 1, wherein the proximal coil has a radiopacity lower than that of the distal coil.

4. The device of claim 1, wherein a wire size of the distal coil is about 0.152 mm (0.006 inches) or less.

5. The device of claim 1, wherein a wire size of the proximal coil is about 0.152 mm (0.006 inches) or less.

6. The device of claim 1, wherein a wire size of the bussing coil is about 0.152 mm (0.006 inches) or less.

7. The device of claim 1, wherein the bussing coil extends further proximally than the proximal coil.

8. The device of claim 1, wherein the bussing coil has a length of at least about 60% of the length of the tube.

9. The device according to claim 1, wherein the proximal coil and the distal coil are each wound in a first direction, while the bushing coil is wound in the opposite second direction.

10. The device according to claim 1, wherein the bushing coil has a pitch smaller than the pitch of the proximal coil and / or the distal coil.

11. The device according to claim 1, wherein the proximal coil, the distal coil, and the bushing coil fill 15% or more of the volume of the annular space.

12. The device according to claim 1, wherein the outer diameter of the outer tube is about 10% or more larger than the outer diameter of the proximal section of the core.

13. The device according to claim 1, further comprising a bushing disposed at the proximal end of the outer tube to assist in coupling the outer tube to the core.

14. The device according to claim 13, wherein the bushing has a chamfered or beveled proximal edge.

15. The device according to claim 1, wherein the tube has at least one of a three-beam section, a two-beam section, and a one-beam section.

16. The device according to claim 1, wherein the flattened distal section of the core has a suitable bending surface, and the suitable bending surface of the flattened distal section is aligned with the suitable bending surface of a portion of the tube on the flattened distal section.

17. A core having a proximal section and a distal section, A grooved outer tube coupled to the core such that the distal section of the core passes into and is surrounded by the tube structure, the outer tube and the core defining an annular space between the inner surface of the outer tube and the distal section of the core disposed within the outer tube, and the outer diameter of the outer tube being larger than the outer diameter of the proximal section of the core. A distal coil surrounding a portion of the distal section of the core, A proximal coil disposed proximal to the distal coil and surrounding a portion of the distal section of the core, And a bushing coil disposed on the distal coil and the proximal coil. Comprising. At least one of the proximal coil, the distal coil, and the bushing coil is wound in a direction opposite to that of the other coils. The distal coil, the proximal coil, and the bushing coil fill 15% or more of the volume of the annular space. Intravascular device.

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