JP2024503692A - High torque guidewire device - Google Patents

Abstract

A guidewire configured to provide high torsional stiffness without deleteriously increasing bending stiffness is disclosed. Such devices provide a high torsional stiffness to bending stiffness ratio. A guidewire device has a core with a proximal section and a distal section. A distal section of the core is coupled to the micromachined outer tube such that the distal section of the core enters the outer tube and is surrounded by the outer tube. [Selection diagram] Figure 1

Description

Cross-reference of related applications
[0001] This application is a continuation-in-part of U.S. patent application Ser. , which claims priority to U.S. patent application Ser. No. 17/382,271, filed July 21, 2021, entitled "High Torque Guidewire Device." This application further claims priority to and the benefit of U.S. Provisional Patent Application No. 63/180,061, filed April 26, 2021, entitled "High Torque Guidewire Device." The entire contents of each of the above applications are incorporated by reference in their entirety.

[0002] Guidewire devices are often used to guide or guide catheters or other interventional devices to target anatomical locations within a patient's body. Typically, a guidewire is threaded into and through the patient's vasculature to reach a target location, such as at or near the patient's heart or brain. X-ray imaging is commonly utilized to assist in navigating the guidewire to the target location. In many instances, a guidewire is placed within the body during an interventional procedure, and the guidewire may be used to guide multiple catheters or other interventional devices to a target anatomical location.

[0003] Guidewires are available in a variety of outer diameter sizes. Commonly used sizes include, for example, 0.254 mm (0.010 inch), 0.356 mm (0.014 inch), 0.406 mm (0.016 inch), 0.457 mm (0.018 inch) , 0.610 mm (0.024 inch), 0.889 mm (0.035 inch), and 0.965 mm (0.038 inch), but these widely available sizes are smaller in diameter. or larger. Because torque transmission is a function of diameter, larger diameter guidewires typically have higher torque transmission (to effectively transmit torque from the proximal portion of the wire to the more distal portion of the wire). capacity, or “torque capacity”). On the other hand, smaller diameter guidewires typically have greater flexibility.

[0004] A guidewire with good torque capability provides effective navigation and rotation at the proximal end and rotation at the distal end, which can be important when navigating through tortuous anatomical structures. This is advantageous because it achieves good alignment between the corresponding movements of. Simply increasing the size of the guidewire can improve its torque capability, but the stiffness of the guidewire can also be increased excessively. A guidewire that is too stiff can lead to difficulty in initially placing the guidewire at the target treatment site. Furthermore, while there are known methods for increasing guidewire flexibility, such as reducing the diameter of the core wire, these methods often sacrifice the torqueability of the device.

[0005] Accordingly, a guidewire having dimensions suitable for a variety of endovascular procedures (including, for example, cerebrovascular and cardiovascular endovascular procedures) that can provide enhanced torque capability without excessive stiffness. A device is required. In other words, there remains a need for guidewire devices that can provide high levels of torsional stiffness.

[0006] From the following description of embodiments, read in conjunction with the accompanying drawings and appended claims, various objects, features, characteristics, and advantages of the present invention will become apparent, more readily appreciated, and all. It forms part of this specification. In the drawings, like reference numerals may be utilized to designate corresponding or similar parts in various figures. The various elements are not necessarily drawn to scale.

[0007] FIG. 4 illustrates an embodiment of a guidewire device having a core and an outer tube that can utilize one or more of the components described herein. [0008] FIG. 4 illustrates an exemplary embodiment of a guidewire device that includes a tube having an outer diameter that is greater than the outer diameter of the proximal section of the core. [0009] FIG. 3 is a detailed view of the distal section of the guidewire of FIG. 2 with the tube structure removed to better show the underlying features of the device. [0010] FIG. 3 is a detailed view of the tube of the guidewire of FIG. 2; [0011] FIG. 3 is a cross-sectional view of the distal section of the guidewire of FIG. 2 showing beam alignment of the one-beam section of the tube with respect to the flattened distal section of the core. [0012] FIG. 3 is a cross-sectional view of the guidewire of FIG. 2 showing that the outer diameter of the tube is greater than the outer diameter of the proximal section of the core. FIG. 3 is a cross-sectional view of the guidewire of FIG. 2 showing that the outer diameter of the tube is greater than the outer diameter of the proximal section of the core. [0013] Guidewire devices according to the present disclosure (designated “A24 soft”) have been shown to advantageously provide higher torsional stiffness than other prior art guidewire devices. 2 is a graph showing torsional stiffness of a guidewire device versus sample torsion, comparing (attached) FIG. Guidewire devices according to the present disclosure (designated "A24 soft") relative to other prior art guidewire devices have been shown to advantageously provide higher torsional stiffness. 2 is a graph showing the torsional stiffness of the guidewire device versus the torsion of the sample, comparing the torsional stiffness of the guidewire device. [0014] Bending of various guidewire embodiments according to the present disclosure (designated “A24 Soft,” “A24 Standard,” and “A24 Support”) with respect to equivalent stainless steel (304V) wire diameters. It is a graph showing a stiffness profile. [0015] These respective bending relative to other prior art guidewire devices demonstrate that greater torque is provided by the guidewire devices disclosed herein but bending stiffness is not adversely affected. 1 is a graph comparing stiffness profiles. These respective bending stiffness profiles relative to other prior art guidewire devices demonstrate that greater torque is provided by the guidewire devices disclosed herein but bending stiffness is not adversely affected. This is a graph for comparison. These respective bending stiffness profiles relative to other prior art guidewire devices demonstrate that greater torque is provided by the guidewire devices disclosed herein but bending stiffness is not adversely affected. This is a graph for comparison.

Introduction
[0016] FIG. 1 schematically depicts general components of a guidewire 100 that may utilize one or more features described in more detail below. The guidewire 100 shown has a core 102 and an outer tube 104. Core 102 is shown having a distal section 103 (also referred to herein as distal core 103) that extends into outer tube 104. The distal core 103 may be tapered, either continuously or in one or more discrete sections, such that the more distal section is tapered compared to the more proximal section. , will have a smaller diameter and higher flexibility. In some embodiments, the distal-most section of the core 102 may be flattened to have a ribbon-like shape with a flattened, rectangular, or oval cross-section. For example, the distal core 103 may be ground with a gradual taper to a smaller radius at the distal end.

[0017] Core 102 and tube 104 are typically formed of different materials. For example, tube 104 is preferably formed from a material with relatively high flexibility and resiliency, such as Nitinol, whereas core 102 has relatively low flexibility and resiliency, such as stainless steel. can be formed from a material having It may be advantageous to form the core 102 from stainless steel (or other material with a comparable modulus of elasticity). This is because it allows the distal tip to maintain its shape when selectively bent/shaped by the surgeon, and because stainless steel allows for more responsive translational motion. The purpose is to provide sufficient elastic modulus. Although these materials are currently preferred, other suitable materials such as polymers or other metals/alloys may be additionally or alternatively utilized.

[0018] Tube 104 is coupled to core 102 in a manner that beneficially enables torsional forces to be transmitted from core 102 to tube 104, thereby further transmitting torsional forces distally by tube 104 ( (e.g., using gluing, soldering, and/or welding). A medical grade adhesive or other suitable material may be used to bond tube 104 to core wire 102 to form an atraumatic covering at distal end 110 of the device.

[0019] The outer tube 104 can have a cutout pattern that forms a fenestration 106 within the tube. The pattern of fenestrations 106 may include, for example, promoting a preferred bending direction, reducing or eliminating a preferred bending direction, or progressively increasing flexibility along the longitudinal axis. may be arranged and configured to provide desired flexibility characteristics to tube 104. Examples of cutout patterns and other guidewire device features that may be utilized in the guidewire devices described herein are found in U.S. Patent Application Publication No. 2018/0193607, U.S. Patent Application Publication No. 2018/0071496, and are presented in detail in US Patent Application Publication No. 2020/0121308, each of which is incorporated herein by reference in its entirety.

[0020] The proximal section (extending proximally from tube 104) of guidewire device 100 provides sufficient guidewire length to deliver to the target anatomical region. Extend proximally for the required length. Guidewire device 100 typically has a length ranging from about 50 cm to about 350 cm, and more typically about 200 cm, depending on the requirements of the particular application. Tube 104 can have a length ranging from about 5 cm to about 350 cm, and more typically from about 15 cm to about 50 cm (such as about 25 cm to about 40 cm).

[0021] Guidewire device 100 can have a diameter from about 0.254 mm (0.010 inch) to about 0.965 mm (0.038 inch). However, larger or smaller sizes may be utilized depending on the needs of the particular application. For example, certain embodiments include 0.356 mm (0.014 inch), 0.406 mm (0.016 inch), 0.457 mm (0.018 inch), 0.610 mm (0.024 inch), etc. It can have an outer diameter size that corresponds to standard guidewire sizes or other sizes that are common for guidewire devices. The distal section 103 of the core 102 has a diameter of about 0.51 mm (about 0.002 inches), or within the range of about 0.0254 to 1.27 mm (about 0.001 to 0.050 inches). It may be tapered so that In some embodiments, the distal tip may be flattened (e.g., 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 of, for example, approximately 0.001 inch by 0.003 inch. In some embodiments, tube 104 has a length within a range of approximately 3 cm to 350 cm.

[0022] Additional features and details regarding the above components are described in further detail below. The examples below have corresponding catheters of approximate size greater than or equal to about 0.0686 mm (0.027 inches), thus reducing the size of the annular space between the inner surface of the catheter and the outer surface of the guidewire. The guidewire is advantageously sized at least about 0.024 inches to limit but still allow relative movement between the inner surface of the catheter and the outer surface of the guidewire. It can be particularly beneficial in applications. In such implementations, the guidewires described herein have a diameter sufficient to restrict the annular space in the distal section of the device while maintaining effective torque capability and lateral flexibility. can be provided. These sizes are not limiting, and the same features and details described below may be utilized with guidewires smaller or larger than 0.610 mm (0.024 inch).
Distal section features
[0023] FIG. 2 depicts an embodiment of a guidewire 200. Unless otherwise specified, guidewire 200 can have any of the general features described above in connection with guidewire 100. Like reference numerals indicate like parts herein. As shown, guidewire 200 has a core 202 and an outer tube 204 with a distal section 203 of core 202 inserted into tube 204. Outer tube 204 has a plurality of fenestrations 206. A polymer-based adhesive can form the atraumatic distal tip 210.

[0024] Core 202 includes a proximal section 201 (also referred to herein as proximal core 201) that is disposed proximal to outer tube 204 and is not inserted into outer tube 204. It also has. Proximal core 201 can have a friction reducing coating, such as polytetrafluoroethylene (PTFE) and/or other suitable coating material. Tube 204 may further include a coating, a suitable hydrophilic coating, and/or other suitable coating materials.

[0025] 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, whereas tube 204 has an outer diameter of about 0.024 inches. have However, other core and/or tube sizes may be utilized. Preferably, tube 204 is about 10% or more, preferably about 15% to about 80% or more, or more preferably about 20% to about 20% of the outer diameter of proximal core 201. having an outer diameter that is about 70% or more (such as about 25% or more to about 35% or more).

[0026] This is further illustrated in the cross-sectional views of FIGS. 6 and 7. As shown, the outer diameter (D1) of proximal core 201 is smaller than the outer diameter (D2) of tube 204. The ratio of D2 to D1 may be, for example, from 1.1 to 3, more preferably from 1.15 to about 2, or from about 1.2 to about 1.75.

[0027] As mentioned above, the larger outer diameter of the tube 204 can better accommodate a particular desired catheter size at the distal tip portion of the catheter, thereby allowing the tube to fit over the guidewire. The size of the annular space between the guidewire and the catheter during catheter placement can be reduced. This is particularly beneficial in more distal sections of the guidewire that are more likely to be navigated through deeper, more tortuous portions of the patient's vasculature.

[0028] However, increasing the diameter of the core 202 to accommodate the larger diameter of the tube 204 may provide the core 202 with an excessively high stiffness for use in a particular desired application. There is. Therefore, increasing the size of tube 204 relative to core 202 while maintaining a small core 202 allows for a higher potential while allowing the benefit of a larger tube 204 in the distal section of guidewire 200. It becomes possible to use a flexible core 202.

[0029] However, as will be explained in more detail below, providing tube 204 with a larger outer diameter than core 202 may create other challenges. Specifically, the difference in diameter between outer tube 204 and distal core 203 enlarges the annular space between the outer surface of distal core 203 and the inner surface of tube 204. Because the tube 204 can have greater flexibility than the distal core 203, the distal core 203 is positioned with its center offset from the centerline of the tube 204 as the wire advances through the bend. obtain. As the guidewire is moved through the vasculature, this off-centering can prevent rotational motion from being transmitted smoothly distally, thereby causing forces to It may accumulate and be released abruptly, causing the guidewire to "snap" and/or "whip" into an undesired preferred rotational position. This interruption of tactile sensation and rotational control of the guidewire may make it more difficult for the operator to position the guidewire in the intended rotational direction, thereby delaying the interventional procedure, Optimal results result in the inability to access the target location or even the risk of tissue damage.

[0030] Embodiments described herein facilitate centering the distal core 203 radially within the tube 204 even though the tube 204 has a larger outer diameter than the proximal core 201. Beneficially provides additional features to assist. One or more centering mechanisms may be included to beneficially reduce undesirable whip and/or snap of the guidewire (i.e., the centering mechanism may improve rotational control), thereby allowing the user to Greater rotational control can be achieved and tactile handling of the guidewire can be improved.

[0031] FIG. 3 depicts the guidewire 200 with the tube 204 removed to better visualize the distal core 203 and some of the other underlying components. An enlarged view of the distal section is shown. As shown, core 202 has one or more transition zones 208, where core 202 tapers to a smaller diameter. Distal end section 211 of core 202 may be flattened. The one or more transition zones 208 may be discrete, with one or more sections of a core of substantially continuous outer diameter disposed therebetween. Alternatively, distal core 203 may have a substantially continuous taper along all or most of its length.

[0032] A bushing 212 may be included at the point forming the junction to which the proximal end of tube 204 is attached. Bushing 212 can have an outer diameter that substantially matches the outer diameter of proximal core 201. Bushing 212 may be formed from the same material as tube 204 (eg, Nitinol). Bushing 212 provides better centering between core 202 and tube 204 and/or reduces the amount of adhesive required to bond the separate components. Although shown here as a tube, the bushing 212 may have alternative geometries, such as a coil, a braid, a slotted/notched tube, and the like.

[0033] As shown, 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 bushing 212 may also be chamfered or beveled. Even if the distal end of bushing 212 is covered by tube 204, providing chamfers/bevels on both ends of bushing 212 eliminates the need to manufacture and ensure proper orientation of the bushing. and eliminate the possibility of misorientation.

[0034] The illustrated guidewire 200 has a proximal coil 216, a distal coil 218, and a bushing coil 220 positioned above the proximal coil 216 and distal coil 218. Distal coil 218 is preferably formed of radiopaque materials such as platinum group, gold, silver, palladium, iridium, osmium, tantalum, tungsten, bismuth, dysprosium, and gadolinium. Thus, distal coil 218 preferably allows x-ray visualization of the distal end of guidewire 200 during the procedure. Distal oil 218 can have a length of about 0.5 cm to about 20 cm, or more typically about 3 cm to about 15 cm (such as about 10 cm).

[0035] Proximal coil 216 may be formed from a non-radio-opaque material, such as stainless steel, other suitable metal, suitable polymer, or other suitable material. Proximal coil 216 may be inserted at a point adjacent to or near the proximal end of distal coil 218 and/or at any point along the length of distal core 203 (most commonly may be attached to the distal core 203 (at or near each end of the proximal coil 216). The proximal coil 216 can have a length of about 1 cm to 25 cm, or more typically about 3 cm to 20 cm (such as about 5 cm to 15 cm). Technically, distal coil 218 may extend further proximally to replace proximal coil 216. However, materials that work well as radiopaque markers (eg, platinum) are relatively expensive. Additionally, their use as a filler material to fill a large portion of the annular space may cause the distal section of the guidewire 200 to become excessively bright when imaged under fluoroscopy. , thus not allowing the operator to visualize other areas of interest. Accordingly, proximal coil 216 is preferably separate from distal coil 218 and formed from a different material than distal coil 218.

[0036] Proximal coil 216 and distal coil 218 help fill a portion of the annular space between distal core 203 and tube 204. Although the coil embodiments shown herein are shown as having wires with circular cross-sections, it will be appreciated that other types of coils may be utilized. For example, the centering coil may be edge-wound and/or may have a ribbon cross-section, rectangular cross-section, oval cross-section, or other non-circular cross-sectional shape.

[0037] Proximal coil 216 and distal coil 218 help fill a portion of the annular space, but additional annular space remains, especially if a somewhat larger tube 204 is utilized. The wire size of proximal coil 216 and distal coil 218 may be expanded to fill additional space. However, increasing the wire size too much can impart too much stiffness to the device. Preferably, the wire size of proximal coil 216 and distal coil 218 is less than or equal to about 0.203 mm (0.008 inch) or about 0.152 mm (0.006 inch), or more preferably. is less than or equal to about 0.102 mm (0.004 inch), such as less than or equal to about 0.0508 mm (0.002 inch).

[0038] Guidewire 200 can have a bushing coil 220 to help fill the remainder of the annular space. A bushing coil 220 may be disposed over proximal coil 216 and distal coil 218. A bushing coil 220 can extend over both proximal coil 216 and distal coil 218. Similar to proximal coil 216 and distal coil 218, the wire diameter of bushing coil 220 is preferably limited. For example, if a metal material is utilized, the wire diameter of the bushing coil is less than or equal to about 0.203 mm (0.008 inch), or less than or equal to about 0.152 mm (0.006 inch), or more preferably about 0. .102 mm (0.004 inch) or less (such as about 0.0508 mm (0.002 inch) or less). Bushing coil 220 may be formed of stainless steel and/or other suitable materials such as another metal or polymer. In embodiments utilizing polymeric materials, the modulus of elasticity may be significantly lower compared to metallic materials, and therefore the wire diameter of the coil may be larger without unduly affecting bending stiffness. In at least some embodiments, the wire diameter of one or more coils (e.g., bushing coil 220) is up to about 0.635 mm (0.025 inch), up to about 0.508 mm (0.020 inch), or up to about 0.015 inches.

[0039] By using bushing coil 220 in addition to proximal coil 216 and distal coil 218, the distance between distal core 203 and tube 204 can be reduced without using excessively large sized coils. Helps fill the annular space. This helps keep the distal core 203 centered within the tube 204, thereby preventing the undesirable effects of misalignment described above while also minimizing the impact on the bending flexibility of the device. .

[0040] In some embodiments, bushing coil 220 may substantially match proximal coil 216 and distal coil 218. Alternatively, bushing coil 220 can extend further proximally than proximal coil 216, as shown. This allows bushing coil 220 to further fill the annular space where proximal coil 216 cannot. That is, the tapered profile of distal core 203 allows even more proximal portions of bushing coil 220 to be accommodated even if certain more proximal portions of the annular space do not accommodate both proximal coil 216 and bushing coil 220. can be filled by an extended portion of. Bushing coil 220 preferably extends along a significant portion of the length of tube 204. For example, the bushing coil 220 may be about 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 at least about the length of the tube 204. It can have a length of 85%.

[0041] In a preferred embodiment, proximal coil 216 and distal coil 218 are each wound in a first direction, while bushing coil 220 is wound in an opposite second direction. It is wound backwards. This advantageously inhibits interlocking and sticking of bushing coil 220 with proximal coil 216 or distal coil 218. Additionally, bushing coil 220 can have a different pitch (eg, a smaller pitch) than the pitch of proximal coil 216 or distal coil 218. For example, the proximal coil 216 and/or the distal coil 218 may be from about 0.0508 mm (0.002 inch) to about 0.203 mm (0.008 inch) or from about 0.0762 mm (0.003 inch) The bushing coil 220 may have a pitch of about 0.178 mm (0.007 inch), whereas bushing coil 220 may have a pitch of about 0.0254 mm (0.001 inch) to about 0.152 mm (0.006 inch) or about 0. It can have a pitch of from 0.002 inches to about 0.005 inches.

[0042] Proximal coil 216, distal coil 218, and bushing coil 220 are preferably configured to fill a significant portion of the volume of the annular space between distal core 203 and tube 204. be done. For example, the proximal coil 216, the distal coil 218, and the bushing coil 220 account for about 20% or more, about 35% or more, about 50% or more, about 60% or more, about 70% or more of the volume of the annular space. , about 80% or more, or up to about 90% or more. Of course, other conventional guidewires may have joints or bushings that occupy a large portion of the annular space in the particular portion of the guidewire in which they are located. However, considering the total length of the outer tube, these joints and bushings fill a relatively small portion of the overall volume of the annular section.

[0043] The principles of the centering mechanism described herein may be utilized with other structural configurations to provide beneficial centering effects. For example, while the embodiments described above describe various centering mechanisms with a core as the "inner member" and a microfabricated tube as the "outer member," in addition or alternatively, the described centering mechanisms Other structures may be utilized as external and/or internal members along with one or more of the centering mechanisms.

[0044] For example, the internal member may be a wire (such as the ground core described above), a tube (such as a metal or polymer hypotube or a metal or polymer microfabricated tube), a braid, or a coil. It's fine. As a further example, the external member is a tube (e.g., a metallic or polymeric hypotube or a metallic or polymeric microfabricated tube), a braid, a coil, or a polymeric tube that has been assembled with a braid or coil. good. The centering mechanism can include a set of coils, as described above, or additionally or alternatively, other structures to effectuate centering of the inner member within the outer member. It is also possible to have For example, one or more of the coils 216, 218, 220 may be connected to one or more tubes (e.g., metal or polymer hypotubes or metal or polymer microfabricated tubes), sections of a braid, etc. , or may be replaced by a set of stacked rings.

[0045] FIG. 4 shows the tube 204 separated from the core 202 and some of the other components of the device. Tube 204 extends between proximal end 222 and distal end 224. The fenestrations 206 formed within the tube 204 can be made according to a variety of cutout patterns. Preferably, the overall effect of the fenestrations provides a gradient of flexibility across the tube 204, where the flexibility increases as it approaches the distal end 224. Typically, the depth of the notches is increased, the spacing between adjacent notches is reduced, and/or the number of axially extending beams 226 connecting each circumferentially extending ring 228 is increased. Greater flexibility can be obtained by removing larger portions from the original material, such as by reducing.

[0046] The illustrated embodiment may have, for example, a three-beam section 230 (three beams connecting each of adjacent pairs of rings), a three-beam section 230 having a two-beam section 232 (two beams connects each of an adjacent pair of rings) and the two-beam section 232 transitions to a one-beam section 234 (one beam connects each of an adjacent pair of rings). Within each of these sections, the notch depth and/or notch spacing may further be adjusted to provide smooth gradients of flexibility within and between sections. For example, the two-beam section 232 can have a distance between the notches that becomes progressively smaller toward the distal end 224. The two-beam section 232 can then transition into a one-beam section 234, which itself has a distance between notches that becomes progressively smaller toward the distal end 224.

[0047] One-beam section 234 can have a length, for example, from about 0.5 cm to about 3 cm, or from about 0.75 cm to about 2 cm. Two-beam section 232 can have a length, for example, from about 4 cm to about 16 cm, or from about 6 cm to about 12 cm. Three-beam section 230 can have a length, for example, from about 12 cm to about 36 cm, or from about 18 cm to about 30 cm. In other words, three-beam section 230 may be approximately two to five times larger than two-beam section 232, and two-beam section 232 may be approximately two to five times larger than one-beam section 234. It has been found that designing tube 204 with such ratios of cutout/beam sections provides an effective balance of axial, lateral, and torsional stiffness in many applications.

[0048] Tube 204 can further have a distal-most 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. Providing a relatively short two-beam section at section 235 provides additional surface area for applying adhesive material at or near the distal end 224 of the tube 204 to be adhered, thereby providing This allows for a stronger bond between the material and any internal components that are glued thereto.

[0049] Certain sections of tube 204 can have notches that are offset in the direction of rotation to avoid forming any suitable bending surfaces. For example, an angular offset may be applied after each cut or series of cuts so that the resulting overall pattern of beams 226 within tube 204 is not aligned to form a suitable bending surface.

[0050] Other sections of tube 204 can have suitable curved surfaces. For example, a one-beam section 234 may be aligned as shown in FIG. 4, with each beam offset approximately 180 degrees from the previous beam. These beams may further be aligned with the curved 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.
Effective torque and bending torque ratio
[0051] FIGS. 8 and 9 illustrate that the guidewire devices of the present disclosure can provide greater torque (ie, torsional stiffness) compared to various prior art devices. 8 and 9 and elsewhere herein, devices labeled "A24 soft" represent examples of guidewire devices described herein, whereas other designations refer to other conventional means a technological device. Specifically, "A14 soft" means an Aristotle® 14 guidewire (0.356 mm (0.014 inch) outer diameter, sold by Scientia Vascular) with a soft profile and "A18 "Soft" means an Aristotle® 18 guidewire (0.457 mm (0.018 inch) outer diameter, sold by Scientia Vascular) with a soft profile; Synchro ² (0.356 mm (0.014 inch) outer diameter sold by Stryker Neurovascular) and Chikai14 (0.356 mm (0.014 inch) outside diameter sold by Asahi Intecc Medical) "A14 Soft Core Wire" and "A18 Soft Core Wire" are the same as "A14 Soft" and "A18 Soft" but without an outer tube or other components Core wire only. In other figures, the designation "Fathom 16" refers to the Fathom 0.406 mm (0.016 inch) outside diameter wide wire sold by Boston Scientific. The notation "A14" is synonymous with "AR14", "A18" is synonymous with "AR18", and so on.

[0052] As shown, "A24 Soft" is more effective at providing torsional stiffness than comparable prior art devices. Table 1 shows the rotational stiffness (averaged over all measurement points over the entire 35 cm distal section) of the guidewire device "A24 Soft" and some other prior art guidewire devices. The data in FIGS. 8 and 9 are summarized by showing.

[0053] Advantageously, the high torque provided by the disclosed guidewire devices does not come at the cost of significantly reducing bending flexibility. FIG. 10 shows various guidewire embodiments according to the present disclosure (labeled "A24 Soft," "A24 Standard," and "A24 Support") for equivalent stainless steel (304V) wire diameters. Figure 3 shows a profile of bending stiffness (i.e. flexural rigidity). Since the bending stiffness of a beam is a constant that is directly related to the cross-sectional dimensions of the beam, the measured guidewire stiffness can be related to a constant for the stainless steel wire such that it will provide an equal bending stiffness measurement. .

[0054] To perform this measurement procedure, the distal tip of the guidewire to be measured is clamped in a collet pin vise and the guidewire tip is pulled out of the vise. Stick out. The guidewire tip was placed to align the flattened tip of the core (if applicable) in a horizontal orientation, and measurements were taken in the direction in which shaping was intended. Additional measurement points were tested by advancing the wire within the collet and adjusting the position of the wire as necessary to extend the guide wire past the midpoint of the load cell roller.

[0055] Figures 11-13 compare their respective bending stiffness profiles against other conventional guidewire devices, with the A24 guidewire device providing greater torque but with lower bending stiffness. This indicates that there will be no adverse effects. This is also the case where some of the comparison devices have smaller sizes and are therefore expected to have greater bending flexibility (ie, less bending stiffness).

[0056] The data provided herein indicates that guidewire devices made in accordance with the present disclosure are capable of providing relatively large torques without significantly and detrimentally increasing bending stiffness. There is. Accordingly, the "to-bending torque" ratio can be utilized as a useful metric to highlight the beneficial properties of the guidewire devices disclosed herein. The "to-bending torque" ratio is a value that indicates the relationship between torsional stiffness (numerator) and bending stiffness (denominator). Although the exact values may vary depending on the units utilized for each input measurement unit, comparisons can be made between different devices as long as the units are chosen consistently. In Table 2, the bending torque ratio is shown in units of radian ^-1 , which means that the numerator of rotational stiffness, which is in units of (N·m ² /rad), is converted to the bending torque, which is in units of N·m ² It is obtained by dividing by the denominator of stiffness.

[0057] The data provided in FIGS. 8-13 and Tables 1 and 2 demonstrate that such to-bending torque ratios are appropriate for the guidewires disclosed herein and for the selection of comparable devices. It can be used to calculate. The guidewire devices disclosed herein advantageously provide a higher bending torque ratio than prior art devices. In some implementations, this type of comparison may be made between devices of similar size. That is, for a given guidewire size, the guidewire devices disclosed herein improve Provides a high bending torque ratio. For example, some embodiments can have an outer diameter size of about 0.024 inches or less.

[0058] As further illustrated by the data in FIGS. 8-13 and Tables 1 and 2, guidewire devices according to the present disclosure have a 0.5 cm distal section of the guidewire device (e.g., approximately 0.5 cm from the distal end). 0.5 cm), bending torque of more than 160 rad ^-1 , about 200 rad ^-1 or more, about 250 rad ^-1 or more, about 300 rad ^-1 or more, about 350 rad ^-1 or more, about 400 rad ^-1 or more, or about 450 rad ^-1 or more ratio can be provided. Other guidewires tested were unable to provide these values of torque to bend ratio.

[0059] In some embodiments, a guidewire device according to the present disclosure provides a 1.5 cm distal section of the guidewire device (e.g., about 1.5 cm from the distal end) of 80 rad ⁻¹ or more, about A bending torque ratio of 100 rad ⁻¹ or greater, or about 120 rad ⁻¹ or greater can be provided. No other guidewire device tested was able to provide these values of bending torque ratio.

[0060] In some embodiments, a guidewire device according to the present disclosure has a 1.0 cm distal section of the guidewire device (e.g., about 1.0 cm from the distal end) of 130 rad ⁻¹ or more, about A bending torque ratio of 150 rad ⁻¹ or greater, or about 170 rad ⁻¹ or greater can be provided. No other guidewire device tested was able to provide these values of bending torque ratio.

[0061] In some embodiments, a guidewire device according to the present disclosure provides a 2.0 cm distal section of the guidewire device (e.g., about 2.0 cm from the distal end) of 50 rad ⁻¹ or more, about A bending torque ratio of 60 rad ⁻¹ or greater, or about 65 rad ⁻¹ or greater can be provided. No other guidewire device tested was able to provide these values of bending torque ratio.

[0062] In some embodiments, a guidewire device according to the present disclosure has a 15 rad ⁻¹ or more, about A bending torque ratio of 20 rad ⁻¹ or greater, or about 25 rad ⁻¹ or greater can be provided. No other guidewire device tested was able to provide these values of bending torque ratio.

[0063] In some embodiments, a guidewire device according to the present disclosure has an 8.0 cm distal section of the guidewire device (e.g., about 8.0 cm from the distal end) of 8 rad ⁻¹ or more, about A bending torque ratio of 9.5 rad ⁻¹ or greater, or about 11 rad ⁻¹ or greater can be provided. No other guidewire device tested was able to provide these values of bending torque ratio.

[0064] Other bending torque ratios for the devices tested can be readily determined using the data provided by FIGS. 8-13 and summarized in Tables 1 and 2.
Abbreviated list of defined terms
[0065] Although particular embodiments of the present disclosure have been described with reference to specific configurations, parameters, components, elements, etc., this description is exemplary and does not limit the scope of the claimed invention. not be interpreted as such.

[0066] Furthermore, for any given element of the components of the described embodiments, any of the possible alternatives listed for this element or component may be specifically Unless stated otherwise, they can generally be used individually or in combination with each other.

[0067] Additionally, unless stated otherwise, numerical values expressing quantities, components, distances, or other measurements as used in this specification and claims are optionally referred to as "about" or a synonym thereof. It is understood as being modified. When terms such as "about," "approximately," or "substantially" are used in conjunction with a referenced amount, value, or condition, less than 20%, less than 10% of the referenced amount, value, or condition; , less than 5%, less than 1%, less than 0.1%, or less than 0.01%. While not attempting to limit the application of the doctrine of equivalents to the claims, it should be noted that, at a minimum, each numerical parameter should be construed in the light of the significant figures recited by applying normal rounding techniques. It is.

[0068] Any headings and subheadings used herein are for organizational purposes only and are not intended to be used to limit the scope of this description or the claims.

[0069] 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 states otherwise. Please note. Thus, for example, embodiments that refer to a single referent (eg, a small device) may also include more than one such referent.

[0070] Embodiments described herein may have different characteristics, features (e.g., materials, components, parts, elements, parts, and/or components) described in other embodiments described herein. It will be further appreciated that the content may include portions). Accordingly, various features of a given embodiment may be combined with and/or incorporated into other embodiments of the present disclosure. Therefore, the disclosure of particular features for a particular embodiment of this disclosure should not be construed as limiting the application and inclusion of the features to only this particular embodiment. Rather, it will be appreciated that other embodiments may also include these features.

Claims (20)

A guidewire device configured to provide high rotational stiffness without significantly increasing bending stiffness, the guidewire comprising:
a core having a proximal section and a distal section;
a microfabricated outer tube coupled to the core such that the distal section of the core enters the outer tube and is surrounded by the outer tube;
Equipped with
The guidewire device includes:
a rotational stiffness to bending stiffness ratio of about 160 rad ⁻¹ or more at about 0.5 cm from the distal end of the guidewire device;
a rotational stiffness to bending stiffness ratio of about 80 rad ⁻¹ or more at a position about 1.0 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 130 rad ⁻¹ or more at a position about 1.5 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 50 rad ⁻¹ or more at a position about 2.0 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 15 rad ⁻¹ or more at about 5.0 cm from the distal end; or
a rotational stiffness to bending stiffness ratio of about 8rad ⁻¹ or more at a position of about 8.0 cm from the distal end;
A guidewire device that provides one or more of: The outer tube and the core define an annular space between an inner surface of the outer tube and an outer surface of the distal section of the core, and an outer diameter of the outer tube is on the proximal side of the core. The guidewire of claim 1, wherein the guidewire is larger than the outer diameter of the section. The guidewire device of claim 2, further comprising a distal coil surrounding a portion of the distal section of the core. 4. The guidewire device of claim 3, further comprising a proximal coil disposed proximal to the distal coil and surrounding a portion of the distal section of the core. 5. The guidewire device of claim 4, further comprising a bushing coil disposed over at least a portion of one or both of the distal coil and the proximal coil. 4. The guidewire device of claim 3, wherein the distal coil has greater radiopacity than stainless steel. 5. The device of claim 4, wherein the proximal coil has lower radiopacity than the distal coil. 6. The device of claim 5, wherein the bushing coil extends further proximally than the proximal coil. 6. The device of claim 5, wherein the bushing coil has a length that is at least about 60% of the length of the outer tube. 6. The device of claim 5, wherein at least one of the proximal coil, the distal coil, and the bushing coil is wound in the opposite direction of the other coil. 5. The proximal coil and the distal coil are each wound in a first direction, while the bushing coil is reverse wound in an opposite second direction. 10. The device according to 10. 6. The device of claim 5, wherein the bushing coil has a pitch that is less than the pitch of the proximal coil and/or the distal coil. 6. The device of claim 5, wherein the proximal coil, the distal coil, and the bushing coil fill 15% or more of the volume of the annular space. 2. The device of claim 1, wherein the outer diameter of the outer tube is about 10% or more greater than the outer diameter of the proximal section of the core. A guidewire device configured to provide high rotational stiffness without significantly increasing bending stiffness, the guidewire comprising:
a core having a proximal section and a distal section;
a microfabricated outer tube coupled to the core such that the distal section of the core enters the outer tube and is surrounded by 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;
a bushing coil disposed over at least a portion of one or both of the distal coil and the proximal coil;
Equipped with
The outer tube and the core define an annular space between an inner surface of the outer tube and an outer surface of the distal section of the core, and an outer diameter of the outer tube is on the proximal side of the core. larger than the outer diameter of the section;
The guidewire device includes:
a rotational stiffness to bending stiffness ratio of about 160 rad ⁻¹ or more at about 0.5 cm from the distal end of the guidewire device;
a rotational stiffness to bending stiffness ratio of about 80 rad ⁻¹ or more at a position about 1.0 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 130 rad ⁻¹ or more at a position about 1.5 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 50 rad ⁻¹ or more at a position about 2.0 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 15 rad ⁻¹ or more at about 5.0 cm from the distal end; or
a rotational stiffness to bending stiffness ratio of about 8rad ⁻¹ or more at a position of about 8.0 cm from the distal end;
A guidewire device that provides one or more of: 16. The device of claim 15, wherein the proximal coil, the distal coil, and the bushing coil fill 15% or more of the volume of the annular space. 16. The device of claim 15, wherein the outer diameter of the outer tube is about 10% or more greater than the outer diameter of the proximal section of the core. 5. The proximal coil and the distal coil are each wound in a first direction, while the bushing coil is reverse wound in an opposite second direction. 15. The device according to 15. 16. The device of claim 15, wherein the bushing coil extends further proximally than the proximal coil. A guidewire device configured to provide high rotational stiffness without significantly increasing bending stiffness, the guidewire comprising:
a core having a proximal section and a distal section;
a micromachined outer tube coupled to the core such that the distal section of the core enters an outer tube and is surrounded by an outer tube, the outer diameter of the outer tube comprising: a micromachined outer tube that is about 10% or more 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;
a bushing coil disposed over at least a portion of one or both of the distal coil and the proximal coil;
Equipped with
the proximal coil, the distal coil, and the bushing coil fill 15% or more of the volume of the annular space;
The outer tube and the core define an annular space between an inner surface of the outer tube and an outer surface of the distal section of the core, and an outer diameter of the outer tube is on the proximal side of the core. larger than the outer diameter of the section;
The guidewire device includes:
a rotational stiffness to bending stiffness ratio of about 160 rad ⁻¹ or more at about 0.5 cm from the distal end of the guidewire device;
a rotational stiffness to bending stiffness ratio of about 80 rad ⁻¹ or more at a position about 1.0 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 130 rad ⁻¹ or more at a position about 1.5 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 50 rad ⁻¹ or more at a position about 2.0 cm from the distal end;
a rotational stiffness to bending stiffness ratio of about 15 rad ⁻¹ or more at about 5.0 cm from the distal end; or
a rotational stiffness to bending stiffness ratio of about 8rad ⁻¹ or more at a position of about 8.0 cm from the distal end;
A guidewire device that provides one or more of:

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