Guidewire with enlarged micromachined distal section

Abstract

A guidewire having a core wire and an outer tube is disclosed, wherein a distal section of the core is inserted into the outer tube. The outer diameter of the tube is greater than the outer diameter of the proximal section of the core wire. The guidewire also includes a proximal coil and a radiopaque distal coil, both disposed on the distal section of the core. A liner coil is disposed over the proximal coil and the distal coil. The proximal coil, the distal coil, and the liner coil assist in filling the annular space between the core and the tube, thereby centering and aligning the core with the tube.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Patent Application No. 17 / 154,777, filed on January 21, 2021, entitled “Guidewire Having Enlarged, Micro-Fabricated Distal Section” and U.S. Provisional Patent Application No. 62 / 965,005, filed on January 23, 2020, entitled “Guidewire Having Enlarged, Micro-Fabricated Distal Section”. Each of the foregoing applications is incorporated herein by reference in its entirety. Background Art

[0003] Guidewire devices are typically used to introduce or guide catheters or other interventional devices into a target anatomical location in a patient's body. Typically, a guidewire enters and passes through the patient's vascular system to reach a target location, which may be, for example, at or near the patient's heart or brain. Radiographic imaging is typically used to assist in navigating the guidewire to the target location. In many cases, a guidewire is placed in the body during an interventional procedure, in which a guidewire can be used to guide multiple catheters or other interventional devices to the target anatomical location.

[0004] Guidewire can have various outer diameters. For example, widely used sizes include 0.010, 0.014, 0.016, 0.018, 0.024, 0.035 and 0.038 inches, although guidewires may also be smaller or larger in diameter. Because torque transmission is a function of diameter, guidewires with larger diameters generally have greater torque transmission (the ability to effectively transmit torque from the proximal section of the wire to the more distal section of the wire). On the other hand, guidewires with smaller diameters generally have greater flexibility.

[0005] The size of a catheter used in conjunction with a guidewire will be determined to have an inner diameter that is slightly larger than the outer diameter of the guidewire to enable the catheter to be positioned over and translated over the guidewire. The size difference between the guidewire and the catheter can affect the ability of the catheter to travel along the guidewire. For example, the larger the annular space between the outer diameter of the guidewire and the inner diameter of the catheter, the greater the potential radial excursion the catheter may experience, and the more difficult it will be to navigate the catheter over the guidewire. In the event of excessive radial excursion, the distal end of the catheter may have a higher risk of becoming stuck in the vasculature or other anatomical structures of the patient, rather than following smoothly along the guidewire path.

[0006] Typically, the size of the guidewire is selected to minimize the amount of annular space between the guidewire and a given catheter size required or desired for a particular operation, thereby limiting the type of the above-mentioned problem. However, there are several challenges in this approach. For example, increasing the size of the guidewire may also excessively increase the rigidity of the guidewire, potentially reaching an undesirable level for the initial placement of the guidewire at the target treatment site. In addition, although there are known methods (such as reducing the core wire diameter) to increase the flexibility of the guidewire, these methods are generally at the expense of the torquability of the device.

[0007] Therefore, there is a need for a guidewire device that can be manufactured with a relatively large outer diameter at least at a distal section, minimizing the annular space between the guidewire and compatible catheters of certain sizes, and also providing sufficient flexibility and torquability along its length. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Various objects, features, characteristics and advantages of the present invention will become apparent and more easily understood from the description of the embodiments in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification, wherein the same reference numerals in the various drawings represent corresponding parts, and the various elements depicted are not necessarily drawn to scale; wherein:

[0009] Figure 1 An embodiment of a guidewire device having a core and an outer tube is shown and may utilize one or more of the components described herein;

[0010] Figure 2 An exemplary embodiment of a guidewire device having a tube having an outer diameter greater than an outer diameter of a proximal section of a core is shown;

[0011] Figure 3 yes Figure 2 A detailed view of the distal section of the guidewire with the tubing structure removed to better illustrate the basic features of the device;

[0012] Figure 4 yes Figure 2 Detailed view of the guidewire tube;

[0013] Figure 5 yes Figure 2 a cross-sectional view of a distal section of a guidewire showing alignment of the beams of the single beam section of the tube with the flat distal section of the core; and

[0014] Figure 6 and Figure 7 yes Figure 2 A cross-sectional view of a guidewire showing that the outer diameter of the tube is larger than the outer diameter of the proximal section of the core. DETAILED DESCRIPTION

[0015] Introduction

[0016] Figure 1 The general components of a guidewire 100 are schematically illustrated, and may utilize one or more features described in greater detail below.

[0017] The guide wire 100 shown comprises a core 102 and an outer tube 104. The core 102 comprises a distal section 103 (also referred to as distal core 103 in this article) extending into the outer tube 104 as shown in the figure. The distal core 103 can taper continuously or in one or more discrete sections so that more distal sections have less diameter and greater flexibility than more proximal sections. In certain embodiments, the distalmost section of the core 102 can be flattened into a band-like shape with a flat, rectangular or elliptical (oblong) cross section. For example, the distal core 103 can be ground, thereby tapering to the smaller diameter at the distal end.

[0018] The core 102 and the tube 104 are typically formed of different materials. For example, the tube 104 is preferably formed of a relatively flexible and resilient material (such as Nitinol), while the core 102 can be formed of a relatively less flexible and resilient material (such as stainless steel). Forming the core 102 from stainless steel (or other materials having a similar elastic modulus) may be advantageous because it allows the distal tip to maintain shape when selectively bent / shaped by an operator, and because stainless steel provides sufficient elastic modulus to provide more sensitive translational movement. Although these materials are currently preferred, other suitable materials, such as polymers or other metals / alloys, may be used in addition or alternatively.

[0019] Tube 104 is coupled to core 102 in a manner that advantageously allows torsional forces to be transferred from core 102 to tube 104, and thereby further distally transferred by tube 104. A medical grade adhesive or other suitable material may be used to couple tube 104 to core wire 102 at distal end 110 of the device to form an atraumatic covering.

[0020] The outer tube 104 may include an incision pattern forming a fenestration 106 in the tube. The pattern of the fenestration 106 may be arranged to provide a desired flexibility characteristic to the tube 104, including, for example, promoting a preferred bending direction, reducing or eliminating a preferred bending direction, or increasing the gradient of flexibility along the longitudinal axis. Examples of incision patterns and other guide wire device features that can be used in the guide wire device described herein are provided in detail in U.S. Patent Application Publications Nos. 2018 / 0193607, 2018 / 0071496, and 2020 / 0121308, the entire contents of each of which are incorporated herein by reference.

[0021] The proximal section of guidewire device 100 (part extending proximally from tube 104) extends proximally to a length that is necessary for providing enough guidewire length to be delivered to the target anatomical region. Guidewire device 100 typically has a length ranging from about 50 cm to about 350 cm, more commonly about 200 cm, depending on specific application needs. Tube 104 can have a length ranging from about 5 cm to about 350 cm, more typically from about 15 cm to about 50 cm (such as about 25 cm to about 40 cm).

[0022] Guidewire device 100 can have a diameter of about 0.010 inch to about 0.038 inch, but can also use larger or smaller size according to specific application needs.For example, specific embodiments can have an outer diameter corresponding to a standard guidewire size, such as 0.014 inch, 0.016 inch, 0.018 inch, 0.024 inch, or other sizes common to guidewire device. The distal section 103 of core 102 can taper to a diameter of about 0.002 inch, or a diameter in the range of about 0.001 to 0.005 inch. In certain embodiments, the distal tip can be flattened (such as to a rectangular cross section) to further enhance bending flexibility, while minimizing the reduction of the cross-sectional area required for tensile strength. In such an embodiment, the cross section can have a size of, for example, about 0.001 inch and takes advantage of 0.003 inch. In certain embodiments, pipe 104 has a length in the range of about 3 to 350cm.

[0023] The additional features and details about the aforementioned assembly will be described in more detail hereinafter. The following example may be particularly useful in application: wherein, the size of the corresponding catheter is determined to be approximately 0.027 inches or larger, so the size of the guide wire is advantageously determined to be approximately 0.024 inches or larger, to limit the amount of annular space between the inner surface of the catheter and the outer surface of the guide wire, but still allow relative movement between them. In such an implementation, the guide wire described herein can provide enough diameters in the distal section of the device to limit the annular space, while still maintaining effective torsion and lateral flexibility. However, these sizes are not restrictive, so the same features and details described below can also be used for guide wires less than or greater than 0.024 inches.

[0024] Improved guidewire device with enlarged distal section

[0025] Figure 2An example of a guidewire 200 is shown. Unless otherwise noted herein, the guidewire 200 may include any of the general features described above with respect to the guidewire 100, wherein the same reference numerals represent the same components. As shown, the guidewire 200 includes a core 202 and an outer tube 204, wherein a distal section 203 of the core 202 is inserted into the tube 204. The outer tube 204 includes a plurality of fenestrations 206. A polymer-based adhesive may form a distal tip 210 that prevents damage.

[0026] The core 202 also includes a proximal section 201 (also referred to herein as the proximal core 201), which is arranged proximal to the outer tube 204 and is not inserted into the outer tube 204. The proximal core 201 may include a friction-reducing coating (such as polytetrafluoroethylene (PTFE) and / or other suitable coating materials). The tube 204 may also include a coating, preferably including a suitable hydrophilic coating and / or other suitable coating materials.

[0027] Preferably, the outer diameter of tube 204 is slightly larger than the outer diameter of proximal core 201. In one exemplary embodiment, proximal core 201 has an outer diameter of about 0.018 inches, while tube 204 has an outer diameter of about 0.024 inches. However, other core and / or tube sizes may also be used. Preferably, the outer diameter of tube 204 is about 10% or greater than the outer diameter of proximal core 201, more preferably about 15% to about 80%, or more preferably about 20% to about 70%, such as about 25% to about 35%.

[0028] This is through Figure 6 and Figure 7 The cross-sectional view of is further shown. As shown, the outer diameter (D1) of the proximal core 201 is less than the outer diameter (D2) of the tube 204. The ratio of D2 to D1 can be, for example, about 1.1 to about 3, more preferably about 1.15 to about 2, or about 1.2 to about 1.75.

[0029] As described above, the larger outer diameter in tube 204 can better match certain desired catheter sizes at the distal tip portion of the catheter and thereby reduce the amount of annular space between the guidewire and the catheter during placement of the catheter over the guidewire. This is particularly beneficial at more distal sections of the guidewire, which are more likely to be navigated through deeper, more tortuous portions of the patient's vascular system.

[0030] However, increasing the diameter of the core 202 to match the larger diameter of the tube 204 may make the core 202 too stiff to be used in certain desired applications. Therefore, maintaining a smaller core 202 while increasing the size of the tube 204 relative to the core 202 allows for the use of a more flexible core 202 while still being able to realize the benefits of a larger tube 204 at the distal section of the guidewire 200.

[0031] However, as explained in more detail below, providing a tube 204 having an outer diameter greater than that of the core 202 brings other challenges. In particular, the difference in diameter between the outer tube 204 and the distal core 203 enlarges the annular space between the outer surface of the distal core 203 and the inner surface of the tube 204. Because the tube 204 can be more flexible than the distal core 203, when the wire passes through the bend, the distal core 203 may be positioned to deviate from the centerline of the tube 204. When the guide wire moves through the vascular system, this deviation can interfere with the smooth distal transmission of the rotational movement to cause the accumulation and sudden release of force, which causes the guide wire to move to an undesirable preferential rotation position in a "snap" and / or "whip" manner. This interference with the tactile and rotational control of the guide wire can make it more difficult for the operator to position the guide wire as expected, thereby increasing the risk of delayed interventional surgery, poor results, inability to enter the target position, and even tissue damage.

[0032] The embodiments described herein beneficially provide additional features that help to radially center the distal core 203 within the tube 204 even if the tube 204 has a larger outer diameter than the proximal core 201. One or more centering mechanisms may be included to beneficially reduce undesirable jerk and / or snap movements of the guidewire (i.e., the centering mechanism may improve rotational control), thereby enabling the user to have greater rotational control and improved tactile handling of the guidewire.

[0033] Figure 3 An enlarged view of the distal section of guidewire 200 is shown, wherein tube 204 is removed to better visualize distal core 203 and some other following components. As shown, core 202 includes one or more transition zones 208, where core 202 tapers to a smaller diameter. The distal section 211 of core 202 can be flat. The one or more transition zones 208 can be discrete, wherein one or more sections of the core with a substantially continuous outer diameter are arranged therebetween, or distal core 203 can have a substantially continuous taper along all or most of its length.

[0034] A sleeve 212 may be included at the point where the proximal end of the tube 204 is attached to the joint. The sleeve 212 may have an outer diameter that substantially matches the outer diameter of the proximal core 201. The sleeve 212 may be formed of the same material as the tube 204 (e.g., Nitinol). The sleeve 212 provides better centering between the core 202 and the tube 204 and / or reduces the amount of adhesive required to join the separate components. Although the sleeve 212 is shown herein as a tube, the sleeve 212 may have alternative geometries such as a coil, a braid, a slotted / slit tube, etc.

[0035] As shown, the bushing 212 may also include a chamfered or beveled surface 214 at 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 though the distal end of the bushing 212 will be covered by the tube 204, providing the bushing 212 with chamfers / bevels at both ends facilitates manufacturing, eliminates the need to ensure proper orientation of the bushing and eliminates the possibility of incorrect orientation.

[0036] The illustrated guidewire 200 includes a proximal coil 216, a distal coil 218, and a liner coil 220 positioned over the proximal coil 216 and the distal coil 218. Preferably, the distal coil 218 is formed of a radiopaque material such as platinum group, gold, silver, palladium, iridium, osmium, tantalum, tungsten, bismuth, dysprosium, gadolinium, etc. Thus, the distal coil 218 preferably allows for radiographic visualization of the distal side of the guidewire 200 during surgery. The distal coil 218 may have a length of about 0.5 cm to about 20 cm, or more typically about 3 cm to about 15 cm, for example, about 10 cm.

[0037] The proximal coil 216 can be formed of a non-radiopaque material (such as stainless steel, other suitable metals, suitable polymers or other suitable materials, etc.). 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 coincident length of 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 about 1 to 25 cm, or more typically about 3 to 20 cm, such as a length of about 5 to 15 cm. Technically, the distal coil 218 can be further extended proximally to replace the proximal coil 216. However, materials (e.g., platinum) used as radiopaque markers are relatively expensive. In addition, when imaging under X-ray fluoroscopy, they may cause the distal section of the guidewire 200 to be too bright as a packaging material filling most of the annular space, and therefore do not allow the operator to see other areas of concern. Therefore, the proximal coil 216 is preferably separate from the distal coil 218 and formed of a different material than the distal coil 218 .

[0038] The proximal coil 216 and the distal coil 218 assist in filling some of the annular space between the distal core 203 and the tube 204. Although the coil examples shown herein are shown as wires having a circular cross-section, it should be understood that other coil types may also be used. For example, one or more centering coils may be edge-wound and / or may have a ribbon-like, rectangular, oval, or other non-circular cross-sectional shape.

[0039] Although the proximal coil 216 and the distal coil 218 assist in filling some of the annular space, additional annular space also exists, especially when a slightly larger tube 204 is used. The wire size of the proximal coil 216 and the distal coil 218 can be increased to fill more space. However, increasing the wire size too much may introduce excessive stiffness to the device. Preferably, the wire size of the proximal coil 216 and the distal coil 218 is about 0.008 inches or less, or about 0.006 inches or less, or more preferably about 0.004 inches or less, such as about 0.002 inches or less.

[0040] To assist in filling the remainder of the annular space, the guidewire 200 may include a liner coil 220. The liner coil 220 may be disposed over the proximal coil 216 and the distal coil 218. The liner coil 220 may extend over the entirety of both the proximal coil 216 and the distal coil 218. As with the proximal coil 216 and the distal coil 218, the wire diameter of the liner coil 220 is preferably limited. For example, the wire diameter of the liner coil may be about 0.008 inches or less, or about 0.006 inches or less, or more preferably about 0.004 inches or less, for example about 0.002 inches or less. The liner coil 220 may be formed of stainless steel and / or other suitable materials, such as another metal or polymer.

[0041] The use of liner coil 220, in addition to proximal coil 216 and distal coil 218, also assists in filling the annular space between distal core 203 and tube 204 without using an oversized coil. This helps maintain distal core 203 centered within tube 204, which prevents the undesirable effects of misalignment already described above, while also minimizing the effect on the bending flexibility of the device.

[0042] In some embodiments, the liner coil 220 may substantially coincide with the proximal coil 216 and the distal coil 218. Alternatively, as shown, the liner coil 220 may extend further proximally than the proximal coil 216. This allows the liner coil 220 to fill more of the annular space even in portions that the proximal coil 216 cannot fill. That is, due to the tapered profile of the distal core 203, some more proximal sections of the annular space do not match the proximal coil 216 and the liner coil 220, but may still be filled by further extended proximal sections of the liner coil 220. Preferably, the liner coil 220 extends along most of the length of the tube 204. For example, the length of the liner coil 220 may be at least about 60% of the length of the tube 204, or at least about 75% of the length of the tube 204, or at least about 80% of the length of the tube 204, or at least about 85% of the length of the tube 204.

[0043] In a preferred embodiment, the proximal coil 216 and the distal coil 218 are each wound in a first direction, while the liner coil 220 is counter-wound in an opposite second direction. This advantageously limits the interlocking and bonding of the liner coil 220 with either the proximal coil 216 or the distal coil 218. The liner coil 220 may also have a pitch that is different (e.g., narrower) than the pitch of the proximal coil 216 or the distal coil 216. For example, the proximal coil 216 and / or the distal coil 218 may have a pitch of about 0.002 inches to about 0.008 inches or a pitch of about 0.003 inches to about 0.007 inches, while the liner coil 220 may have a pitch of about 0.001 inches to about 0.006 inches, or a pitch of about 0.002 inches to about 0.005 inches.

[0044] Preferably, the proximal coil 216, the distal coil 218 and the liner coil 220 are configured to fill most 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 liner coil 220 can be configured to fill approximately 20% or more, 35% or more, 50% or more, 60% or more, 70% or more, 80% or more, or even up to about 90% or more of the volume of the annular space. Of course, other conventional guide wires can include joints or bushings that fill most of the annular space at the specific position of the guide wire where they are located. However, considering the entire length of the outer tube, such joints and bushings then fill the relatively less volume of the entire annular space.

[0045] The centering mechanism principles described herein can be used with other structural configurations to provide a beneficial centering effect. For example, although the above embodiments describe various centering mechanisms with a core as an "inner member" and a micromachined tube as an "outer member", other structures can be used in addition or in lieu of one or more of the described centering mechanisms as an outer member and / or inner member.

[0046] For example, the inner member can be a wire (such as a ground core as described above), a tube (e.g., a metal or polymer hypotube or a metal or polymer micro-machined tube), a braid, or a coil. By way of other examples, the outer member can be a tube (e.g., a metal or polymer hypotube or a metal or polymer micro-machined tube), a braid, a coil, or a polymer tube filled with a braid or coil. The centering mechanism may include a coil group as described above, or may additionally or alternatively include other structures in the outer member for providing centering of the inner member. For example, one or more of the coils 216, 218, 220 may be replaced by one or more tubes (e.g., a metal or polymer hypotube or a metal or polymer micro-machined tube), a braided segment, or a stacked ring group.

[0047] Figure 4The tube 204 is shown separated from the core 202 and some other components of the device. The tube 204 extends between a proximal end 222 and a distal end 224. The fenestrations 206 formed in the tube 204 can be made according to a variety of cut patterns. Preferably, the overall effect of the fenestrations provides a flexibility gradient across the tube 204, with the increased flexibility increasing more toward the distal end 224. In general, greater flexibility can be provided by removing more raw material (such as by increasing the depth of the cuts, reducing the space between adjacent cuts, and / or reducing the number of axially extending beams 226 connecting each circumferentially extending ring 228).

[0048] For example, the illustrated embodiment may include a three-beam section 230 (three beams connecting each adjacent paired ring), which transitions to a double-beam section 232 (two beams connecting each adjacent paired ring), which transitions to a single-beam section 234 (a single beam connecting each adjacent paired ring). Within each of these sections, the cut depth and / or cut spacing may also be adjusted to provide a smooth intra- and inter-sectional flexibility gradient. For example, the double-beam section 232 may have a gradually decreasing distance between cuts as it advances toward the distal end 224. It may then transition to a single-beam section 234, which itself then includes a gradually decreasing distance between cuts as it advances toward the distal end 224.

[0049] For example, the single beam section 234 may have a length of about 0.5 cm to about 3 cm, or about 0.75 cm to about 2 cm. For example, the double beam section 232 may have a length of about 4 cm to about 16 cm, or about 6 cm to about 12 cm. For example, the triple beam section 230 may have a length of about 12 cm to about 36 cm, or about 18 cm to about 30 cm. In other words, the triple beam section 230 may be about 2 to 5 times longer than the double beam section 232, which may be about 2 to 5 times longer than the single beam section 234. It has been found that designing the tube 204 with these ratios of cutouts / beam sections provides an effective balance of axial, lateral, and torsional stiffness for most applications.

[0050] The tube 204 may also include a distal-most section 235 having a dual-beam pattern. Preferably, this section is relatively short, such as about 0.5 cm or less, or about 0.25 cm or less, or about 0.15 cm or less. Providing a relatively short dual-beam section at section 235 provides an increased surface area for adhesive material applied at or near the distal end 224 of the tube 204 to bond, thereby allowing a stronger connection between the distal end 224 and any internal components bonded to the distal end 224.

[0051] Certain sections of the tube 204 may have rotationally offset cuts to avoid the formation of any preferred bending planes. For example, an angular offset may be applied after each cut or series of cuts so that the overall resulting pattern of beams 226 in the tube 204 is not aligned in a manner that forms a preferred bending plane.

[0052] Other sections of the tube 204 may include preferred bending planes. For example, the single beam section 234 may be as Figure 4 As shown, each beam is offset from the front beam by about 180°. These beams can also be aligned with the curved plane of the flat distal section 211 of the core. Figure 5 The cross-sectional view shows how the beams 226 of the single beam section 234 are preferably aligned in the same plane as the flat, wider section of the distal section 211 of the core.

[0053] Additional Exemplary Embodiments

[0054] The following embodiments include different combinations of features of the intravascular devices described herein. The embodiments described herein may include characteristics, features (e.g., components, members, elements, parts and / or parts) described in other embodiments described herein. Therefore, the various features of a given embodiment may be combined with other embodiments of the present disclosure and / or incorporated into other embodiments of the present disclosure. Therefore, the disclosure of certain features of a specific embodiment of the present disclosure should not be interpreted as limiting the application or inclusion of the features to a specific embodiment. On the contrary, it should be understood that other embodiments may also include such features.

[0055] Embodiment 1: An intravascular device comprises: a core having a proximal segment and a distal segment; and a slotted outer tube connected to the core so that the distal segment of the core enters 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 segment of the core arranged in the outer tube, wherein an outer diameter of the outer tube is greater than an outer diameter of the proximal segment of the core.

[0056] Example 2: The device according to Example 1 further includes: a distal coil, which surrounds a portion of the distal segment of the core; a proximal coil, which is arranged proximal to the distal coil and surrounds a portion of the distal segment of the core; and a sleeve coil, which is arranged on at least a portion of one of the distal coil and the proximal coil or both of the distal coil and the proximal coil, wherein the distal coil, the proximal coil and the sleeve coil fill at least a portion of the annular space.

[0057] Embodiment 3: The device of embodiment 2, wherein the distal coil is more radiopaque than stainless steel.

[0058] Embodiment 4: The device of Embodiment 2 or 3, wherein the distal coil is less radiopaque than the proximal coil.

[0059] Example 5: The device of any of Examples 2-4, wherein the wire size of the distal coil is approximately 0.006 inches or less.

[0060] Example 6: The device of any of Examples 2-5, wherein the wire size of the proximal coil is approximately 0.006 inches or less.

[0061] Embodiment 7: The device of any of Embodiments 2-6, wherein the wire size of the liner coil is about 0.006 inches or less.

[0062] Example 8: A device according to any of Examples 2-7, wherein the sleeve coil extends further proximally than the proximal coil.

[0063] Embodiment 9: The device of any of Embodiments 2-8, wherein the length of the liner coil is at least about 60% of the length of the tube.

[0064] Embodiment 10: The device according to any one of embodiments 2-9, wherein at least one of the proximal coil, the distal coil and the liner coil is wound in a direction opposite to the other coils.

[0065] Embodiment 11: The device of Embodiment 10, wherein the proximal coil and the distal coil are each wound in a first direction, and the liner coil is counter-wound in an opposite second direction.

[0066] Embodiment 12: The device according to any one of embodiments 2-11, wherein the liner coil has a pitch, and the pitch of the liner coil is smaller than the pitch of the proximal coil and / or the distal coil.

[0067] Embodiment 13: The device of any one of embodiments 2-12, wherein the proximal coil, the distal coil, and the liner coil fill 15% or more of the volume of the annular space.

[0068] Embodiment 14: The device of any of Embodiments 1-13, wherein the outer diameter of the outer tube is approximately 10% or greater than the outer diameter of the proximal section of the core.

[0069] Embodiment 15: The device of any one of embodiments 1-14 further comprising a bushing disposed at a proximal end of the outer tube to assist in coupling the outer tube to the core.

[0070] Embodiment 16: The device of Embodiment 15, wherein the bushing comprises a chamfered or beveled proximal edge.

[0071] Embodiment 17: The device of any one of Embodiments 1-16, wherein the tube comprises at least one of a triple beam section, a double beam section, and a single beam section.

[0072] Embodiment 18: The device of any of Embodiments 1-17, wherein the flat distal segment of the core has a preferred bending plane, and wherein the preferred bending plane of the flat distal segment is aligned with the preferred bending plane of a portion of the tube covering the flat distal segment.

[0073] Example 19: An intravascular device, comprising a core having a proximal segment and a distal segment; a slotted outer tube connected to the core so that the distal segment of the core enters 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 segment of the core arranged within the outer tube; a distal coil, the distal coil surrounding a portion of the distal segment of the core; a proximal coil, the proximal coil being arranged proximal to the distal coil and surrounding a portion of the distal segment of the core; and a liner coil, the liner coil being arranged on at least a portion of one of the distal coil and the proximal coil or on both of the distal coil and the proximal coil, wherein the distal coil, the proximal coil and the liner coil fill at least a portion of the annular space.

[0074] Embodiment 20: An intravascular device comprises: a core having a proximal segment and a distal segment; a slotted outer tube connected to the core so that the distal segment of the core enters 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 segment of the core arranged in the outer tube, wherein an outer diameter of the outer tube is greater than an outer diameter of the proximal segment of the core; a distal coil, the distal coil surrounding a portion of the distal segment of the core; a proximal coil, the proximal coil being arranged proximal to the distal coil and surrounding a portion of the distal segment of the core; and a liner coil, the liner coil being arranged on the distal coil and the proximal coil, wherein at least one of the proximal coil, the distal coil and the liner coil is wound in an opposite direction to the other coils, and wherein the distal coil, the proximal coil and the liner coil fill 15% or more of the volume of the annular space.

[0075] in conclusion

[0076] While certain embodiments of the present disclosure have been described in detail with reference to specific configurations, parameters, components, elements, etc., these descriptions are illustrative and should not be construed as limiting the scope of the claimed invention.

[0077] Furthermore, it should be understood that for any given element or component of the described embodiments, any possible alternatives listed for that element or component may generally be used alone or in combination with each other, unless implicitly or explicitly stated otherwise.

[0078] In addition, unless otherwise indicated, the numbers used in the specification and claims to indicate quantities, components, distances or other measurements should be understood as being optionally modified by the term "about" or its synonyms. When the terms "about", "approximately", "substantially", etc. are used in conjunction with a stated amount, value or condition, they may be considered to refer to an amount, value or condition that deviates from the stated amount, value or condition by less than 20%, less than 10%, less than 5% or less than 1%. At a minimum, and without attempting 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 number of reported significant digits and by applying ordinary rounding techniques.

[0079] Any headings and sub-headings used herein are for organizational purposes only and are not meant to limit the scope of the description or the claims.

[0080] It will also be noted that, as used in this specification and the appended claims, the singular forms "a", "an", and "the" do not exclude plural referents unless the context clearly dictates otherwise. Thus, for example, an embodiment referring to a single referent (e.g., "a widget") may also include two or more such referents.

Claims

1. An intravascular device, comprising: a core having a proximal section and a distal section; a slotted outer tube coupled to the core such that a distal section of the core enters and is surrounded by a tube structure, the outer tube and the core defining an annular space between an inner surface of the outer tube and a distal section of the core disposed within the outer tube, a distal coil surrounding a portion of a distal section of the core; a proximal coil disposed proximally of the distal coil and surrounding a portion of the distal section of the core; as well as a liner coil disposed on at least a portion of one or both of the distal coil and the proximal coil; wherein the outer diameter of the outer tube is greater than the outer diameter of the proximal section of the core; and The distal coil, the proximal coil and the liner coil are arranged in at least a portion of an annular space between an inner surface of the outer tube and a distal section of the core and fill at least a portion of the annular space.

2. The device according to claim 1, wherein: The distal coil is more radiopaque than stainless steel.

3. The device according to claim 1, wherein: The distal coil is more radiopaque than the proximal coil.

4. The device according to claim 1, wherein: The distal coil has a wire size of 0.006 inches or less.

5. The device according to claim 1, wherein: The proximal coil has a wire size of 0.006 inches or less.

6. The device according to claim 1, wherein: The liner coil wire size is 0.006 inches or less.

7. The device according to claim 1, wherein: The liner coil extends proximally further than the proximal coil.

8. The device according to claim 1, wherein: The length of the liner coil is at least 60% of the length of the tube.

9. The device according to claim 1, wherein: At least one of the proximal coil, the distal coil, and the liner coil is wound in an opposite direction to the other coils.

10. The device according to claim 9, wherein: The proximal coil and the distal coil are each wound in a first direction, while the liner coil is counter-wound in an opposite second direction.

11. The device according to claim 1, wherein: The liner coil has a pitch, and the pitch of the liner coil is smaller than the pitch of the proximal coil and / or the distal coil.

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

13. The device according to claim 1, wherein: The outer diameter of the outer tube is 10% or more greater than the outer diameter of the proximal section of the core.

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

15. The device according to claim 14, wherein: The bushing includes a chamfered or beveled proximal edge.

16. The device according to claim 1, wherein The tube includes at least one of a triple beam section, a double beam section, and a single beam section.

17. The device according to claim 1, wherein: The flat distal section of the core has a preferred bending plane, and wherein the preferred bending plane of the flat distal section is aligned with the preferred bending plane of a portion of the tube covering the flat distal section.

18. An intravascular device comprising: a core having a proximal section and a distal section; a slotted outer tube coupled to the core such that a distal section of the core enters and is surrounded by a tube structure, the outer tube and the core defining an annular space between an inner surface of the outer tube and a distal section of the core disposed within the outer tube; a distal coil surrounding a portion of a distal section of the core; a proximal coil disposed proximally of the distal coil and surrounding a portion of the distal section of the core; as well as a liner coil disposed on at least a portion of one or both of the distal coil and the proximal coil, wherein the distal coil, the proximal coil and the liner coil fill at least a portion of the annular space, and wherein the distal coil is less radiopaque than stainless steel, and wherein the distal coil is less radiopaque than the proximal coil.

19. An intravascular device comprising: a core having a proximal section and a distal section; a slotted outer tube coupled to the core such that a distal section of the core enters and is surrounded by a 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, wherein an outer diameter of the outer tube is greater than an outer diameter of a proximal section of the core; a distal coil surrounding a portion of a distal section of the core; a proximal coil disposed proximally of the distal coil and surrounding a portion of the distal section of the core; and a liner coil disposed on the distal coil and the proximal coil, wherein at least one of the proximal coil, the distal coil and the liner coil is wound in a direction opposite to the other coils, and Wherein, the distal coil, the proximal coil and the liner coil fill 15% or more of the volume of the annular space.

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