Microfabricated intravascular devices for aspiration procedures

Abstract

An intravascular device for aspiration procedures is disclosed that provides desirable pushability, torqueability, flexibility, and hoop strength characteristics. The intravascular device incorporates a laminated configuration of micromachined cut patterns that improves the maneuverability of the intravascular device during vascular procedures. The intravascular device may include channels configured to hold radiopaque markers to aid in navigation and location of the intravascular device during the procedure.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Utility Application No. 18 / 374,564, filed September 28, 2023, entitled "MICROFABRICATED INTRAVASCULAR DEVICE FOR ASPIRATION PROCEDURES," and U.S. Provisional Patent Application No. 63 / 411,505, filed September 29, 2022, entitled "MICROFABRICATED INTRAVASCULAR DEVICE FOR ASPIRATION PROCEDURES," the disclosures of each of which are incorporated herein by reference in their entirety.

[0002]

[0002] The present disclosure relates generally to intravascular devices for navigating a patient's vasculature to reach a target location, and more particularly to intravascular devices for aspiration procedures. [Background technology]

[0003] Intravascular devices, such as catheters, are frequently utilized in the medical field to perform delicate procedures deep within the human body. Typically, a catheter is inserted into a patient's femoral, radial, carotid, or cervical vessels and navigated through the patient's vasculature to the required heart, brain, or other target anatomical structure. Often, a guidewire is first routed to the target anatomical structure, and one or more catheters are then advanced over the guidewire and routed to the target anatomical structure. Once in place, the catheter can be used to deliver drugs, stents, embolic devices, radiopaque dyes, or other devices or substances to treat the patient in a desired manner. For example, an intravascular device may be a catheter that is routed to the desired target anatomical structure and provides vacuum suction or aspiration.

[0004] In many applications, such intravascular devices must be angled through tortuous bends and curves in vasculature passageways to reach target anatomical structures. For example, directing a catheter to a portion of the cerebral vasculature requires passage through the internal carotid artery and other tortuous pathways. Such interventional devices require sufficient flexibility, particularly near their distal ends, to navigate such tortuous passageways.

[0005] However, other design aspects must also be considered. For example, the catheter must also be able to provide sufficient torqueability (i.e., the ability to transmit torque applied at the proximal end all the way to the distal end), pushability (i.e., the ability to transmit a pushing force to the distal end rather than bending and bonding the middle section), and structural integrity to perform its intended medical function.

[0006] With regard to torqueability, as a longer length of catheter is advanced into and through the vasculature passage, the amount of frictional surface contact between the catheter and the vasculature tissue increases, preventing easy movement through the vasculature passage. Transmitting torque from the proximal end to the distal end allows the catheter to rotate and overcome the frictional forces, allowing further advancement and positioning.

[0007] In some cases, certain portions of the device are micromachined to increase flexibility. For example, a catheter may include an outer elongated tube that includes a series of machine-cut perforations near its distal end, and sometimes elsewhere. The cuts are typically arranged to define a series of axially extending "beams" that connect a series of circumferentially extending "rings."

[0008] While such microfabrication techniques are advantageous for increasing the flexibility of elongated intravascular components, several challenges remain. Most intravascular devices utilize coils at the distal end of the device to impart desired flexibility characteristics and avoid puncturing or damaging the vasculature or target anatomical structure. While these coils may provide flexibility, they exhibit poor hoop strength (i.e., the ability to maintain the intended cross-sectional circular shape) and tend to ovalize upon the application of vacuum suction or aspiration.

[0009] Furthermore, when pressed, such coils tend to collapse and harden, becoming "slinky," meaning that the coils may be more difficult to navigate effectively through vasculature and small, tortuous spaces. Such coils also tend to be made from stainless steel or other relatively rigid materials that have poor kink resistance, leading to plastic deformation when making tight turns.

[0010]

[0010] Intravascular devices may utilize radiopaque markers placed on the end of the catheter to identify and locate the distal tip of the catheter while within the patient's vasculature. Such radiopaque markers are often placed across the distal end of the catheter. However, these markers are difficult to secure and are often insufficiently secured to the distal end of the catheter. Thus, these markers are prone to becoming dislodged from the distal end of the catheter during the procedure, such as during removal of the catheter from the patient's vasculature. The problem of losing radiopaque markers within the patient's vasculature is particularly pronounced in cerebrovascular procedures.

[0011]

[0011] Thus, there is a long-felt and continuing need for improved intravascular devices and methods that enable the manufacture of such devices. Summary of the Invention

[0012]

[0012] Intravascular devices, such as catheters and / or aspiration catheters, are disclosed that have a microfabricated outer surface. The disclosed intravascular devices have high flexibility at their distal ends while retaining and maintaining good torqueability and pushability for effective navigation of, for example, the cerebral vasculature. The disclosed intravascular devices also exhibit improved hoop strength and are therefore effective for use as aspiration catheters.

[0013] In some embodiments, the intravascular device includes an elongate member extending along a longitudinal axis between a proximal end and a distal end, with a lumen extending from the proximal end to the distal end. The elongate member includes a micro-machined outer surface defining a plurality of axially extending beams and circumferentially extending rings, the micro-machined outer surface contributing to a flexibility gradient of the intravascular device. At least one beam includes an inner surface, an outer surface, and a pair of opposing lateral surfaces, with an angle formed between one or both of the inner and lateral surfaces. The inner and outer surfaces of the beam each include an arc length, and the arc length of the outer surface may be less than or equal to the arc length of the inner surface. In some embodiments, the intravascular device is an aspiration catheter.

[0014] In some embodiments, one or more polymer layers are applied to the inner and / or outer surfaces of the elongate member, hi some embodiments, one or more polymer layers of different hardness and / or modulus are applied to different sections of the elongate member to accommodate a flexibility gradient of the underlying sections of the elongate member.

[0015] In some embodiments, the intravascular device includes a marker band channel in the distal-most section or tip of the elongate member. The marker band channel is sized to receive a radiopaque marker band. The grooved marker band channel includes ridges at the proximal and distal ends of the channel. The proximal and distal ridges maintain the radiopaque marker in place during manipulation of the intravascular device. Additionally, the channel is grooved to a depth such that the radiopaque marker is substantially flush with the outer diameter of the outer surface of the intravascular device.

[0016] In some embodiments, the axial length of the channel is between about 0.01 inch and 0.03 inch, such as 0.019 inch, 0.02 inch, or 0.025 inch, or a range having endpoints selected from any two of the foregoing values. In some embodiments, the thickness of the radiopaque marker is between about 0.0015 inch and 0.0025 inch. When the radiopaque marker is positioned and secured within the channel, the radiopaque marker is substantially flush with the outer diameter of the intravascular device. Adhesive may be wicked between the radiopaque marker and the marker band channel to further mechanically secure the radiopaque marker within the channel.

[0017]

[0017] In one embodiment, a method for manufacturing an intravascular device including a "one-beam" configuration includes the steps of providing a piece of stock material; advancing a blade into the stock material at a cutting depth to form a first cut in the stock material without completely penetrating the stock material, wherein the blade is oriented so that the cutting edge is substantially perpendicular to the longitudinal axis of the stock material; rotating the stock material relative to the blade without advancing the stock material longitudinally relative to the blade; advancing the blade into the stock material to form a second cut; rotating the stock material a second time relative to the blade without advancing the stock material longitudinally relative to the blade; and advancing the blade into the stock material to form a third cut, wherein the blade is advanced into the stock material for the second and third cuts at the same cutting depth as the first cut.

[0018] In some embodiments, the proximal section of the disclosed intravascular device includes a hub or handle equipped with vacuum suction / aspiration capabilities. For example, once the disclosed intravascular device is routed to the target anatomy, a vacuum hose in the hub may be turned on, or a vacuum may be otherwise applied to the catheter, to provide vacuum suction at the target anatomy. Such vacuum suction may enable, for example, removal of blood clots, emboli, and / or other obstructions in the target anatomy.

[0019] In some embodiments, the outer surface of a microfabricated component of an intravascular device includes a plurality of cuts (or perforations). In some embodiments, a plurality of different cut patterns are arranged to provide a flexibility profile or gradient. The plurality of cut patterns may include a first cut pattern that may be different from a second cut pattern, which may be different from a third cut pattern. In some embodiments, the arrangement of the cut patterns involves rotation of the second cut pattern relative to the first cut pattern and rotation of the third cut pattern relative to the second cut pattern, and / or rotation of a beam or set of beams relative to another beam or set of beams.

[0020] In some embodiments, the third cut pattern includes a two-beam arrangement (i.e., two cuts to form each two-beam section) formed by a one-cut-per-beam manufacturing process. In some embodiments, the second cut pattern includes a two-beam arrangement (i.e., four cuts to form each two-beam section) formed by a two-cut-per-beam manufacturing process. In some embodiments, the first cut pattern includes a one-beam arrangement formed by a three-cut manufacturing process. In some embodiments, the first cut pattern is distal to the second cut pattern, and the second cut pattern is distal to the third cut pattern.

[0021] The beams of various configurations (e.g., one beam, two beams, etc.) include an inner / inner surface having a first arc length (i.e., inner arc length) and an outer / outer surface having a second arc length (i.e., outer arc length). For at least some of the beams, the ratio of the first to second arc lengths ranges from about 1.2:1 to 6:1, such as 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, 5.5:1, etc., or within a range having endpoints defined by any two of the above values. The ratio and lengths of the first and second arc lengths may be controlled and / or influenced by the method of manufacturing the intravascular device.

[0022] Unlike conventional catheters, the disclosed intravascular devices do not require a distally extending outer coil to provide the catheter with desired properties, such as catheter flexibility. Rather, the desired properties (e.g., pushability, torqueability, and flexibility) and flexibility gradients are imparted to the elongate member itself by micromachined cut patterns and their layered arrangement along the longitudinal axis of the elongate member. The micromachined cut patterns may work in combination with a polymer coating to provide an effective flexibility profile. Furthermore, the desired properties are imparted by the material(s) used to construct the intravascular device. For example, in some embodiments, the disclosed intravascular devices are constructed from nitinol and / or another suitable alloy.

[0023] The micromachined cut patterns combined with the use of nitinol to form the disclosed intravascular devices offer several benefits.

[0024] First, elongate members with micromachined cut patterns provide greater hoop strength to intravascular devices compared to devices with coils as the primary distal structural member. Hoop strength refers to the device's ability to maintain its intended cross-sectional circular shape. High hoop strength indicates a greater ability to maintain its intended cross-sectional circular shape, which is particularly important in suction applications. Low or insufficient hoop strength means that the intended cross-sectional circular shape may not be maintained, and the cross-sectional shape of the catheter will more easily ovalize when subjected to vacuum or other deforming forces. Ovalization (deformation of the circular shape along the axis) can alter the functional circumference or diameter of the intravascular device and present a hurdle to effectively removing clots or other obstructions. The disclosed intravascular devices provide effective hoop strength and, therefore, can effectively and safely remove clots, emboli, and other targets from a patient's vasculature. Effective removal is due, at least in part, to the intravascular device's improved ability to maintain its desired cross-sectional shape.

[0025] Second, the disclosed intravascular devices having micromachined cut patterns efficiently transmit torque down the length of the intravascular device (i.e., provide good torquability) and efficiently transmit pushing forces down the length of the catheter (i.e., provide good pushability). The micromachined cut patterns enable torquability and pushability of the elongate member without requiring a coil as the primary external structural component, while still maintaining a desired flexibility profile / gradient along the longitudinal axis of the device. That is, the micromachined elongate member itself provides sufficient flexibility at the distal end such that there is no need to attach a distally extending coil to the distal end of the elongate member. Instead, the distal end of the elongate member itself defines the distal end of the device.

[0026] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an indicator of the scope of the claimed subject matter.

[0027] Various objects, features, characteristics and advantages of the present invention will become apparent and more readily appreciated from the following description of embodiments taken in conjunction with the accompanying drawings and appended claims, all of which are a part of this specification. In the drawings, like reference numerals may be utilized to designate corresponding or similar parts in the various views, and the various elements shown are not necessarily drawn to scale. [Brief explanation of the drawings]

[0028] [Figure 1]

[0028] Figure 1 illustrates an exemplary embodiment of an intravascular device having microfabricated components. [Figure 2] 1A-1C illustrate exemplary embodiments of intravascular devices having microfabricated components. [Figure 3]

[0029] 1A-1C illustrate the distal end or section of an exemplary intravascular device having microfabricated components. [Figure 4]

[0030] FIG. 1 is a close-up view of the distal tip of an exemplary intravascular device. [Figure 5A]

[0031] FIG. 1 illustrates a typical cutting process for creating a one-beam cut pattern in a piece of stock material. [Figure 5B] FIG. 1 illustrates the structure of the resulting beam from a standard cutting process. [Figure 5C] FIG. 1 illustrates the structure of the resulting beam from a standard cutting process. [Figure 6A]

[0032] FIG. 10 illustrates an alternative cutting process. [Figure 6B] FIG. 10 illustrates an alternative cutting process. [Figure 6C] 10A-10C show an improved structure of the beam resulting from an alternative cutting process. [Figure 7A]

[0033] FIG. 10 illustrates another alternative cutting process for a two-beam cut pattern. [Figure 7B] FIG. 10 illustrates another alternative cutting process for a two-beam cut pattern. [Figure 7C] FIG. 10 illustrates another alternative cutting process for a two-beam cut pattern. [Figure 7D] FIG. 10 illustrates another alternative cutting process for a two-beam cut pattern. [Figure 7E] FIG. 10 illustrates the resulting beam structure from an alternative cutting process. [Figure 8]

[0034] 8A, 8B and 8C illustrate another alternative cutting process. [Figure 9]

[0035] 9A and 9B show the beam resulting from a typical cutting process for comparison. DETAILED DESCRIPTION OF THE INVENTION

[0029]

[0036] Intravascular devices having microfabricated components are disclosed. In some embodiments, the intravascular device includes an elongated member extending along a longitudinal axis between a proximal end and a distal end, with a lumen extending through the elongated member from the proximal end to the distal end. The elongated member includes microfabricated components defining a plurality of axially extending beams and circumferentially extending rings. The beams include an inner surface, an outer surface, and pairs of lateral surfaces. In some embodiments, the intravascular device is an aspiration catheter. While some examples described herein include reference to a particular type of intravascular device (e.g., an aspiration catheter), it will be understood that the same components, methods, and principles may be applied to other types of intravascular devices, such as other types of catheters and / or guidewires.

[0030]

[0037] In some embodiments, the polymer layer or coating is applied to the inner and / or outer surface of the elongate member. In some embodiments, the disclosed intravascular device includes a marker band channel in the distal-most section of the intravascular device. The marker band channel is sized to receive a radiopaque marker. The grooved marker band channel includes ridges at the proximal and distal ends of the channel. The ridges advantageously maintain the radiopaque marker in place during manipulation of the device. Furthermore, the channel is grooved such that the radiopaque marker is substantially flush with the outer diameter of the elongate member in adjacent sections of the elongate member.

[0031]

[0038] In one embodiment, a method for manufacturing an intravascular device having a one-beam section includes the steps of providing a piece of stock material; advancing a blade into the stock material to form a first cut in the stock material without completely penetrating the stock material, the blade being oriented so that the cutting edge is substantially perpendicular to the longitudinal axis of the stock material; rotating the stock material relative to the blade without advancing the stock material longitudinally relative to the blade; advancing the blade into the stock material to form a second cut; rotating the stock material relative to the blade a second time without advancing the stock material longitudinally relative to the blade; and advancing the blade into the stock material to form a third cut.

[0032]

[0039] In some embodiments, the proximal section of the disclosed intravascular device includes a hub or handle equipped with vacuum suction capabilities. For example, once the disclosed intravascular device is routed to the target anatomy, a vacuum hose in the hub may be turned on, or a vacuum may be otherwise applied, to provide vacuum suction at the target anatomy. Such vacuum suction may enable, for example, removal of blood clots and / or other obstructions in the target anatomy.

[0033]

[0040] In some embodiments, the micromachined outer surface includes a plurality of cut patterns. In some embodiments, the cut patterns are arranged such that a first cut pattern is different from a second cut pattern, and the second cut pattern is different from a third cut pattern. In some embodiments, the third cut pattern includes a two-beam configuration (i.e., two cuts to form two beams between each set of rings) formed by a one-cut-per-beam manufacturing process. In some embodiments, the second cut pattern includes a two-beam configuration (i.e., four cuts to form two beams between each set of rings) formed by a two-cut-per-beam manufacturing process. In some embodiments, the first cut pattern includes a one-beam pattern (i.e., three cuts to form a single beam between each set of rings) formed by a three-cut-per-beam manufacturing process.

[0034]

[0041] Each beam of the various configurations includes an inner surface having a first arc length and an outer surface having a second arc length, and the length ratio of the first and second arc lengths (i.e., the ratio of the inner arc length to the outer arc length) ranges from about 1.2:1 to 6:1. The ratio and lengths of the first and second arc lengths may be controlled and / or influenced by the method of manufacturing the intravascular device.

[0035]

[0042] Unlike conventional catheters, the disclosed intravascular devices do not utilize a distally extending coil as a primary outer structural component to provide the catheter with desired properties, such as flexibility. Rather, the desired properties (e.g., pushability, torqueability, and flexibility) are imparted to the elongate member itself by (at least in part) micromachined cut patterns and their placement along the longitudinal axis of the disclosed intravascular devices. Furthermore, the desired properties may be influenced or imparted by the materials used to construct the intravascular device. For example, in some embodiments, the disclosed intravascular devices are constructed from nitinol and include one or more polymer coatings selected and arranged to contribute to a desired flexibility profile.

[0036] Overview of Intravascular Devices

[0043] 1 and 2 show an exemplary intravascular device 100 comprising an elongate member 104 extending between a proximal end 106 and a distal end 108. A lumen extends between the proximal end 106 and the distal end 108. The inner diameter of the lumen may be between about 0.010 inches and 0.050 inches, such as 0.017 inches to 0.04 inches, 0.019 inches, 0.02 inches, 0.025 inches, 0.03 inches, 0.035 inches, 0.037 inches, 0.038 inches, 0.039 inches, or within a range having endpoints defined by any two of the above values. The outer diameter of the intravascular device may be an outer diameter ranging from about 0.04 inches to 0.06 inches, such as 0.045 inches, 0.047 inches, 0.049 inches, 0.051 inches, 0.053 inches, 0.055 inches, 0.057 inches, or within a range having endpoints defined by any two of the above values.

[0037]

[0044] Intravascular device 100 includes an open lumen to allow, for example, aspiration of a blood clot or other obstructing material from a patient's vasculature. An optional handle / hub / torquer 102 may be attached to proximal end 106. Hub 102 in FIG. 1 is configured as a handle that is actively grasped by the practitioner; hub 102 in FIG. 2 is configured as a handle with paddles that provide additional stability during use of intravascular device 100.

[0038]

[0045] The elongate member 104 may be formed from or include a tubular structure. The elongate member 104 may include a micro-machined outer surface, which may include a plurality of cut patterns or perforations cut into the outer surface. The plurality of perforations may be cut in the outer surface of the proximal section, the distal section, and / or along a longitudinal axis extending between the proximal and distal sections (i.e., the central or mid-section). The perforations may be formed by cutting one or more sections of stock material to form a cut pattern that leaves perforations. The perforations can provide various benefits, including increasing the flexibility of the elongate member 104. Additionally, the perforations may be positioned to provide a flexibility gradient along the longitudinal axis of the intravascular device. In some embodiments, the perforations are positioned to provide improved flexibility (compared to a similar section of stock material without perforations) while maintaining a sufficient circumferential structure to effectively transmit torque.

[0039]

[0046] Elongated member 104 may be of any length necessary to navigate the patient's anatomy to reach the target anatomical area. Typical lengths may be, for example, in the range of about 50 to 300 cm. In catheter embodiments, the outer diameter of elongated member 104 may be in the range of about 0.020 inches to about 0.350 inches, such as about 0.04 inches to about 0.150 inches, although larger or smaller diameters may be utilized according to preference and / or application needs.

[0040]

[0047] In some embodiments, the elongated member 104 includes or is formed from a nickel-titanium alloy that has superelastic properties at body temperature. The elongated member 104 may additionally or alternatively be formed from a material having a modulus of about 3000 MPa to about 4500 MPa or about 3500 MPa to about 4000 MPa. In one embodiment, the elongated member 104 is formed from or includes polyetheretherketone (PEEK). Other polymers with higher moduli may be utilized if cost and / or manufacturing considerations justify it. The elongated member 104 may additionally or alternatively include stainless steel.

[0041]

[0048] The distal-most section of the disclosed intravascular device includes a marker band channel or groove configured to receive a radiopaque marker and hold the marker in place. The marker band channel is more fully described with respect to FIG.

[0042]

[0049] FIG. 3 shows an enlarged view of elongate member 104. A break (indicated by a dashed line) between proximal section 107 and distal section 109 reveals the continuous elongate member 104 extending between the proximal and distal sections 107 and 109. Elongate member 104 includes multiple different micromachined cut patterns. The distal section 109 shown includes a first micromachined cut pattern 120, a second micromachined cut pattern 122, a third micromachined cut pattern 124, and a marker band channel 126. Proximal section 107 may include one or more micromachined cut patterns. For example, third micromachined cut pattern 124 may extend all the way to proximal section 107.

[0043]

[0050] In some embodiments, the third micro-machined cut pattern 124 is a two-beam section with one cut per beam. In some embodiments, the second micro-machined cut pattern 122 is a two-beam section with two cuts per beam. In some embodiments, the first micro-machined cut pattern 120 is a one-beam section with three cuts per beam. These configurations are described in more detail below. Each section of the micro-machined cut pattern transitions into the next section of the micro-machined cut pattern; thus, each section of the micro-machined cut pattern may include a transition section.

[0044]

[0051] The arrangement of the first, second, and third micromachined cut patterns results in a “stacked” configuration, contributing to or forming a gradient flexibility profile. The gradient provides the desired flexibility, pushability, and torqueability characteristics for efficient and safe operation of the disclosed intravascular devices. For example, the stacked arrangement is configured to provide effective column strength along the proximal section of the intravascular device while sufficiently reducing column strength in the distal section. Minimizing column strength at or near the distal end of the device provides greater flexibility or “give” at the distal end. This flexibility means that the intravascular device is less likely to puncture tissue or vessels when contacted during navigation to the target anatomy. Rather, the distal end of the intravascular device will tend to buckle or flex when it encounters resistance from the target anatomy. Thus, the distal section 109 can safely flex while still maintaining a desired shape and diameter, for example, during aspiration procedures.

[0045]

[0052] FIG. 4 shows an enlarged view of the distal region of elongate member 104, including marker band channel 126. Marker band channel 126 is configured to receive a marker, which may be a radiopaque marker to aid in locating and guiding the intravascular device. In some embodiments, the marker is made from tantalum or another suitable radiopaque material. In some embodiments, adhesive is applied between the marker and marker band channel 126 to maintain the marker in place within channel 126. In some embodiments, marker band channel 126 includes a proximal ridge at the proximal section of channel 126 and a distal ridge at the distal-most section of channel 126. In some embodiments, intravascular device 100 extends just beyond the distal ridge. This extension may be beveled (e.g., at about 45 degrees) to aid in atraumatically navigating through the patient's vasculature.

[0046]

[0053] The chamfered extension may have a distance or extension D2 of about 0.0254 mm (0.001 inch) to about 0.0889 mm (0.0035 inch). In some embodiments, the chamfered extension is about 0.0508 mm (0.002 inch). The inner lumen may have a diameter D1 of about 0.762 mm (0.030 inch) to about 1.016 mm (0.040 inch). For example, in some embodiments, the inner lumen may have a diameter D1 of about 0.9652 mm (0.038 inch). The elongate member 104 may have a wall thickness (including the liner) of about 0.0762 mm (0.030 inch) to about 0.127 mm (0.0050 inch).

[0047]

[0054] Advantageously, the proximal and distal ridges of channel 126 maintain the marker in place during removal of the disclosed intravascular device 100, for example, from the patient's vasculature. Thus, the marker resists being pulled away from intravascular device 100 and lost within the patient's vasculature. This problem is particularly acute when navigating the dense vasculature of the brain. The disclosed intravascular device 100 solves this problem by maintaining the marker in place and securely within channel 126. Furthermore, marker band channel 126 is grooved so that when the radiopaque marker is placed within or on channel 126, the outer diameter of intravascular device 100 is substantially constant. That is, the outer extent of the marker will be substantially flush with the outer surface of the intravascular device. The marker may be substantially C-shaped and clamped around channel 126. An adhesive or glue is applied on and around the marker, such as on the junction where the two ends of the C meet. Adhesive may be wicked between the marker and the channel 126, thereby further securing the marker within the channel.

[0048]

[0055] In some embodiments, the marker band channel 126 is between about 0.025 inches and 0.040 inches in length, such as between about 0.020 inches and 0.045 inches in length, or within a range having endpoints defined by any two of the above values.

[0049] Micromachined cut pattern

[0056] The disclosed intravascular devices include microfabricated cut patterns. Examples of various microfabricated cut patterns that may be utilized in addition to the embodiments described herein are shown and described in U.S. Application Publication Nos. 2020 / 0345975 and 2018 / 0177517, the entire contents of each of which are incorporated herein by reference.

[0050]

[0057] In some embodiments, the micromachined cut pattern includes a plurality of beams (axially extending segments remaining after the cuts are made) and rings (circumferentially extending circular segments disposed between each set of cuts). The micromachined cut pattern may include at least a one-beam arrangement and a two-beam arrangement. A one-beam arrangement includes a single beam disposed between each pair of adjacent rings. A two-beam arrangement includes two beams disposed between each pair of adjacent rings. Other embodiments may include sections with other arrangements, such as a three-beam arrangement having three beams between each pair of adjacent rings.

[0051]

[0058] In some embodiments, some beams are rotated relative to one or more other beams to avoid forming straight beams on one side or the other of the intravascular device and / or to avoid or minimize preferred bending axes. For example, an angular offset may be applied to each cut location or every few cut locations (e.g., every second, every third, etc.) to intentionally rotate the positions of the resulting beams and thereby minimize forming preferred bending axes.

[0052]

[0059] In some embodiments, the micromachined cut pattern is arranged to provide improved flexibility (compared to a similar section of unperforated stock material) while maintaining sufficient circumferential structure to effectively transmit torque. For example, starting at the distal-most end of the intravascular device, a one-beam arrangement may be followed proximally by a two-beam arrangement, which may be followed by another two-beam arrangement, which may extend to the proximal end of the intravascular device.

[0053]

[0060] In some embodiments, the disclosed intravascular device includes a third microfabricated cut pattern approximately in the proximal section, a second cut pattern in the intermediate section between the proximal and distal sections, and a first cut pattern approximately in the distal section. In some embodiments, the third microfabricated cut pattern includes a two-beam arrangement formed by a conventional one-cut-per-beam process. In some embodiments, the second microfabricated cut pattern includes a two-beam arrangement formed by a two-cut-per-beam process (described in more detail below). In some embodiments, the first microfabricated cut pattern includes a one-beam arrangement formed by a three-cut-per-beam process (described in more detail below).

[0054]

[0061] In some embodiments, the third micromachined cut pattern extends along the longitudinal axis distally from the hub or handle (attached to the intravascular device at its proximal-most end) from about 60 cm to 180 cm, such as about 100 cm to 160 cm, or using any combination of the above values ​​as endpoints. In some embodiments, the strain relief attachment is disposed between the distal end of the hub or handle and the proximal end of the proximal section of the intravascular device.

[0055]

[0062] In some embodiments, the second cut pattern extends distally from the distal end of the third cut pattern along the longitudinal axis of the intravascular device. In some embodiments, the second cut pattern extends from the distal end of the third cut pattern to the proximal end of the first cut pattern. In some embodiments, the length of the second cut pattern is about 4 cm to 12 cm, about 5 cm to 10 cm, or about 6 cm to 7 cm, or within a range defined by any two of the above values. The distal end of each microfabricated cut pattern may include a transition section to smooth the transition from one microfabricated cut pattern to the next.

[0056]

[0063] In some embodiments, the first cut pattern extends along the longitudinal axis of the intravascular device distally from the distal end of the second cut pattern. In some embodiments, the first cut pattern extends from the distal end of the second cut pattern to the proximal end of the marker band channel (discussed above). In some embodiments, the length of the first cut pattern is about 1 cm to 5 cm, or about 1.5 cm to 4 cm, or about 2 cm to 3 cm, or a length within a range defined by any two of the above values.

[0057]

[0064] The arrangement of the first, second, and third micromachined cut patterns results in a "stacked" configuration, contributing to the gradient of the cut patterns. The gradient provides the desired flexibility, pushability, and torqueability characteristics for efficient and safe operation of the disclosed intravascular devices. For example, the stacked arrangement is configured to provide some column strength along the approximate proximal section of the intravascular device while minimizing column strength in the distal section / end. Minimizing column strength at or near the distal end of the device provides greater flexibility or "give" at the distal end. This flexibility means that the intravascular device will not puncture tissue or vessels when it encounters them during navigation to the target anatomy. Rather, the distal end of the intravascular device will buckle or flex when it encounters resistance from the target anatomy.

[0058]

[0065] In some embodiments, the intravascular device includes one or more polymer coatings. The polymer coatings may be applied on the outer surface of the elongate member, over the micromachined cut pattern. Additionally or alternatively, the polymer coatings may be applied on the inner surface of the intravascular device, under the micromachined cut pattern.

[0059]

[0066] An intravascular device may include multiple polymer coatings, each with a different hardness / durometer and / or modulus. The application of these polymer coatings results in a coating hardness and / or modulus gradient. In some embodiments, the coating gradient may correspond to the gradient of the micromachined cut pattern. Such matching may enhance desired properties of the device and ensure that desired properties (e.g., flexibility, pushability, and / or torqueability) are maintained.

[0060]

[0067] The disclosed intravascular devices (e.g., aspiration catheters) may be constructed from stock materials. Such stock materials may include suitable medical-grade catheter materials, such as, for example, polyetheretherketone (PEEK), polyetherblockamide (PEBA), other polymers, nitinol, stainless steel, radiopaque materials, and / or combinations thereof. In some embodiments, the elongate member is constructed from stock nitinol material.

[0061]

[0068] In contrast to conventional aspiration catheters, the disclosed intravascular device does not use coils extending distally from the hypotube, but rather relies on a gradient of micromachined cut patterns along the longitudinal axis of the intravascular device to provide a balance of strength and flexibility. When coils are typically used to reduce column strength and increase flexibility, such coils have suboptimal hoop strength and tend to ovalize upon application of vacuum. In contrast, for example, the first micromachined cut 124 pattern (which is the most distal cut pattern) and its linear arrangement along the intravascular device are configured to impart effective hoop strength to the intravascular device while also providing sufficient flexibility and avoiding excessive column strength. Because the micromachined cut patterns of the intravascular device are arranged along the longitudinal axis and provide a gradient of strength and flexibility, different sections of the intravascular device can be "tuned" for desired strength and / or flexibility profiles.

[0062] Cut pattern formation

[0069] 5A-5C illustrate an exemplary process for forming a one-beam cut pattern in a piece of stock material 302. The stock material 302 (typically a tubular structure) is positioned within a cutting machine having a blade 304 (or multiple blades). As indicated by arrow 306, the blade 304 is movable along an axis that is perpendicular to the longitudinal axis of the stock material 302 to form perforations 303. While the blade 304 is shown here as moving up and down along a vertical axis, other configurations may have the blade (or multiple blades) moving along a horizontal or even diagonal axis.

[0063]

[0070] To make a cut, blade 304 is brought into contact with stock material 302 and moved inward until a cut is made at the desired depth, with the resulting beam 310 remaining within stock material 302. Blade 304 is then withdrawn from stock material 302. Stock material 302 is then moved longitudinally relative to blade 304, as indicated by arrow 308, until the next desired cut location is aligned with blade 304. The process may then be repeated to form the desired number of cuts.

[0064]

[0071] The depth of the cuts and / or the spacing between cuts may vary from one device to the next, or even from one section of a device to another section of the same device. For example, a section intended to form the distal portion of an intravascular device may include cuts that are relatively deep and / or have relatively small spacing to increase the relative flexibility of the distal portion.

[0065]

[0072] In some embodiments, the stock material 302 may be rotated between successive cuts or between successive sets of cuts to allow for a rotational offset in the resulting beam, as indicated by arrow 312. Further details related to cutting machines and related manufacturing methods are described in U.S. Patent No. 10,232,141, which is incorporated herein by reference in its entirety.

[0066]

[0073] Figures 5B and 5C show in more detail the structure of beam 310 resulting from the standard cutting procedure shown in Figure 5A. Figure 5B shows a front cross-sectional view of stock material 302 along a line extending parallel to the blade path of a particular cut, and Figure 5C shows a close-up view of an edge section of the resulting beam 310. As shown, blade 304 typically has a diameter significantly larger than that of stock material 302 (typical blade diameters may range, for example, from 2 inches to 4 inches). Figure 5B shows blade 304 at its deepest point within stock material 302. After blade 304 is withdrawn, the resulting beam 310 remains.

[0067]

[0074] As best shown in Figure 5C, the resulting beam 310 includes an interior surface 320, an exterior surface 322, and two lateral surfaces 324 (only one is shown in Figure 5C). Each lateral surface 324 joins interior surface 320 along an interior edge 326 and joins exterior surface 322 along an exterior edge 328. An angle 330 is formed where interior surface 320 joins lateral surface 324.

[0068]

[0075] Due to the geometry of the cut, angle 330 will be significantly greater than 90 degrees, typically about 135 degrees. A structural consequence of the size of angle 330 is that the inner arc length along inner surface 320 is smaller than the outer arc length along outer surface 322. Similarly, beam 310 has a substantially uniform radial thickness (indicated by radial line 332a) over most of its circumferential length, but the radial thickness tapers between inner edge 326 and outer edge 328 (indicated by progressively shorter radial lines 332b and 332c). Another structural consequence is that edge 328 will be relatively “sharp.” That is, angle 331 formed between lateral surface 324 and outer surface 322 will be relatively small, such as about 45 degrees or less.

[0069] Improved cutting pattern formation Two-cut process per beam for one-beam configuration

[0076] 6A-6B illustrate an alternative method for forming a beam 410 within a section of stock material 402. As shown in FIG. 6A, the blade 404 is initially advanced into the stock material 402 to a relatively shallow depth compared to the standard cut shown in FIG. 5B. For example, where the standard cut shown in FIG. 5B typically has a depth of about 70% or more of the stock material diameter, the initial cut depth shown in FIG. 6A is about 50% (e.g., about 30% to about 70%).

[0070]

[0077] After the initial cut is made, the stock material 402 is rotated relative to the blade 404 to allow the blade 404 to pass through the stock material 402 a second time, as shown in FIG. 6B. Because the stock material 402 maintains the same longitudinal position relative to the blade during the first and second passes of the blade 404, the second cut is in the same plane as the first cut. During the first cut, a first lateral surface 424a is formed, and a temporary lateral surface 424c is formed. The second cut then removes the temporary lateral surface 424c and cuts additional material to form a second lateral surface 424b.

[0071]

[0078] 6A to 6B gives the impression that the blade 404 rotates clockwise relative to the stock material 402, it will be understood that this is for convenience of illustration only, and that any suitable means of relative rotation between the stock material 402 and the blade 404 may be utilized by rotating the blade 404, the stock material 402, or both. Typically, the stock material 402 will rotate relative to the rotationally stationary blade 404. The relative rotation is preferably about 60 degrees (e.g., about 50 degrees to about 70 degrees or about 55 degrees to about 65 degrees).

[0072]

[0079] 6C shows a close-up view of an edge section of the resulting beam 410. The resulting beam 410 includes an interior surface 420, an exterior surface 422, and a pair of lateral surfaces 424 (a single lateral surface 424b is shown here). Each lateral surface 424 joins the interior surface 420 along an interior edge 426 and joins the exterior surface 422 along an exterior edge 428. An angle 430 is formed where the interior surface 420 joins the lateral surface 424.

[0073]

[0080] 5C, angle 430 of beam 410 is significantly smaller. For example, angle 430 may have a value within a range having a lower endpoint of approximately 75, 80, 85, or 90 degrees and an upper endpoint of 130, 120, 110, or 100 degrees. For example, angle 430 may be approximately 90 degrees such that lateral surface 424b is substantially perpendicular to interior surface 420.

[0074]

[0081] The angle 430 of the beam 410 is also affected by the arc lengths of the inner surface 420 and the outer surface 422. By comparing Figures 6C and 5C, it can be seen that the ratio of inner to outer arc length is greater in the embodiment of Figure 6C compared to the embodiment of Figure 5C, but even in the embodiment of Figure 6C, the outer arc length remains longer than the inner arc length.

[0075]

[0082] The configuration of beam 410 provides a significant improvement over standard beam 310. For example, beam 410 avoids the "sharp" exterior edges 428 present in standard beam 310. In other words, angle 431 formed between lateral surface 424b and exterior surface 422 is greater than 45 degrees, such as between about 50 degrees and about 90 degrees.

[0076]

[0083] The dual-pass cutting process has also been surprisingly found to increase manufacturing efficiency and yield compared to the standard single-pass process. Even with twice the number of blade passes, the dual-pass process requires a shallower depth per cut and typically produces more precise cuts. This has been found to more than compensate for the additional time required to make two cuts per beam. Additionally, the use of a shorter cut depth extends the life of the cutting blade.

[0077]

[0084] In some embodiments, the cutting process is governed by the length of each section of the microfabricated cut pattern (e.g., the length of the proximal, central, and distal sections) and the degree of cutting distribution. For example, parameters related to length and degree may be stored in a software application executed by a computer system. Additionally and / or alternatively, the cutting process may be governed by a desired ratio between the inner arc length and the outer arc length.

[0078] Two-cut process per beam for two-beam configuration

[0085] Also shown is a four-cut process (two cuts per beam) for forming a two-beam configuration. Figures 7A-7D illustrate a four-cut process for forming a two-beam configuration, where each beam is formed from two cuts (sometimes referred to herein as a "two-cut-per-beam, two-beam configuration"). The resulting beams can have substantially the same size and substantially the same ratio of inner arc length to outer arc length.

[0079]

[0086] As shown, blade 604 is initially advanced into stock material 602 to a relatively shallow depth compared to the standard cut shown in Figure 5B. For example, where the standard cut shown in Figure 5B typically has a depth of about 70% or more of the stock material diameter, the initial cut depth shown in Figure 7A is about 25% (e.g., about 15% to about 35%).

[0080]

[0087] After the initial cut is made, the stock material 602 is rotated relative to the blade 604 during further passes of the blade 604 through the stock material 602, as shown in Figures 7B-7D. Because the stock material 602 maintains the same longitudinal position relative to the blade during the first and second passes of the blade 604, the second cut is in the same plane as the first. Note that the particular sequence shown in Figures 7A-7D is exemplary only. The relative rotation of the blade 604 and stock material 602 between cuts may follow a different sequence depending on the direction of rotation, or may instead follow the sequence of Figures 7A, 7C, 7D, 7B, etc.

[0081]

[0088] 7A through 7D gives the impression that the blade 604 rotates (e.g., clockwise) relative to the stock material 602, it will be understood that this is for convenience of illustration only, and that any suitable means of relative rotation between the stock material 602 and the blade 604 may be utilized by rotating the blade 604, the stock material 602, or both. Typically, the stock material 602 will be rotated relative to the rotationally static blade 604.

[0082]

[0089] As the next pair of beams is formed at the next longitudinal position of the elongate member, the stock material may be rotated and offset by some amount. For example, the stock material may be rotated 90 degrees relative to the previous pair of beams. This results in each pair of beams being offset by 90 degrees from the previous pair of beams. Advantageously, axially rotating each beam pair or every few beam pairs (e.g., every two, every three, etc.) down the length of the stock material can minimize the formation of preferred bending planes.

[0083]

[0090] The process of linearly translating and rotating the stock material to form the beams may be repeated as many times as necessary to reach the desired length of the two-beam section.

[0084]

[0091] Similarly, advantageously, the disclosed four-cut process produces a more ideal beam cross-sectional shape. As shown in FIG. 7E, the resulting beam shape avoids flat and / or sharp artifacts or edges that tend to concentrate stress and reduce fatigue life of the device. The four-cut process results in the outer arc length for the beam (i.e., the arc length on the outer surface of the beam) being equal to or even shorter than the inner arc length. Such a shape advantageously reduces "sharp" corners at the outer edge (e.g., see outer edge 328 in FIG. 5C), which tend to concentrate mechanical stress and reduce fatigue life of the device. The beam cross-sectional shape shown in FIG. 7E can also reduce stiffness relative to a similar beam (i.e., a beam with the same cross-sectional area) that has a larger difference between its outer and inner arc lengths.

[0085] Three-cut process per beam for one-beam configuration

[0092] A three-cut process for forming a one-beam configuration or arrangement is also shown. As shown in FIGS. 8A-8C, the blade 704 is initially advanced into the stock material 702 to a relatively shallow depth compared to the standard cut shown in FIG. 5B. For example, where the standard cut shown in FIG. 5B typically has a depth of about 70% or more of the stock material diameter, the initial cut depth shown in FIG. 8A is about 50% (e.g., about 30% to about 70%, typically about 50% or less of the stock material diameter). Note that the specific sequence shown in FIGS. 8A-8C is merely exemplary. The relative rotation of the blade 704 and stock material 702 between cuts may follow a different sequence depending on the direction of rotation, or may instead follow the sequence shown in FIGS. 8B, 8A, 8C, etc.

[0086]

[0093] After the initial cut is made, the stock material 702 may be rotated relative to the blade 704 to allow the blade 704 to advance a second time through the stock material 702, as shown in FIG. 8B. Because the stock material 702 maintains the same longitudinal position relative to the blade during the first and second passes of the blade 704, the second cut is in the same plane as the first cut. During the first cut, a first lateral surface and a first temporary lateral surface are formed, similar to lateral surfaces 424a, 424b shown in FIGS. 6A-6B. A second cut then removes the temporary lateral surface and cuts additional material to form the lateral surfaces of the beam. The stock material 702 may be rotated again, and the blade 704 is advanced a third time through the stock material 702. The third cut removes additional material to form the opposing lateral surfaces of the resulting beam 710.

[0087]

[0094] 8A through 8C gives the impression that blade 704 rotates clockwise relative to stock material 702, it will be understood that this is for convenience of illustration only and that any suitable means of relative rotation between stock material 702 and blade 704 may be utilized by rotating blade 704, stock material 702, or both. Typically, stock material 702 will rotate relative to blade 704, which is rotationally static.

[0088]

[0095] As with other cutting method embodiments described herein, the process of rotating the stock material between cuts and then longitudinally / linearly translating the stock material may be repeated as many times as necessary to reach the desired length of the one-beam configuration. The shallow relative cut depth used in this method can extend the life of the cutting blade compared to conventional one-cut-per-beam and even two-cut-per-beam one-beam sections. Furthermore, the three-cut-per-beam process is particularly suited to larger diameter devices, such as the disclosed aspiration catheter devices having an inner diameter of approximately 0.889 mm (0.035 inches) or other sizes disclosed herein.

[0089]

[0096] Similarly, advantageously, the disclosed three-cut process produces a more ideal beam cross-sectional shape. The resulting beam shape avoids flat and / or sharp artifacts or edges that tend to concentrate stress and reduce fatigue life of the device. The three-cut process results in the outer / outer arc length (i.e., the arc length on the outer surface of the beam) being equal to or shorter than the inner arc length. Such a shape advantageously reduces "sharp" corners at the outer edge (e.g., see outer edge 328 in FIG. 5C ), which tend to concentrate mechanical stress and reduce fatigue life of the device. The resulting beam cross-sectional shape can also reduce stiffness relative to a similar beam (i.e., a beam with the same cross-sectional area) with a larger difference between the outer and inner arc lengths.

[0090]

[0097] As discussed above, beams in any configuration described herein may be rotated from one longitudinal cut location to the next to avoid or minimize alignment of the beams along the longitudinal axis to create a preferred bending plane. For example, lining up all beams of a one-beam section along one side will create a preferred bending direction along the "spine" of the aligned beams. While this may be desirable in some applications, it is typically more preferable for the device to easily bend equally in any direction. "Rotational offset" refers to the amount of rotation of a beam or set of beams from one longitudinal position to the next. For example, in a one-beam configuration, a series of cuts may be made at a first longitudinal position to form a first beam at any 0-degree position. The stock material may then be moved linearly / longitudinally relative to the cutting blade to a second longitudinal position. A cut is then made at the second position to form a second beam. The second beam is preferably rotated relative to the first beam. This process continues as the cutting moves longitudinally down the stock material, forming a continuous beam.

[0091]

[0098] It has been surprisingly discovered that a rotational offset of about 100 degrees to about 150 degrees advantageously minimizes the column strength of the corresponding section of the elongate member in a one-beam configuration, thus minimizing the buckling force required to induce buckling under column / compression loads. Minimizing buckling force is particularly advantageous in the distal section of the elongate member 104, such as in the section having the first cut pattern 120, to reduce the risk of accidental tissue damage. By way of example, the rotational offset may be about 102.5 degrees to about 145 degrees, or about 105 degrees to about 140 degrees, or about 107.5 degrees to about 135 degrees, or about 110 degrees to about 130 degrees, or about 115 degrees to about 125 degrees, or in the most preferred embodiment, about 120 degrees. The rotational offset may be within a range having endpoints defined by any two of the above values.

[0092] Exemplary Benefits of the Multi-Pass Cutting Method

[0099] Figures 9A and 9B show a comparison of the beams resulting from the processes shown in Figures 5A-5B and 7A-8C, respectively. Figure 9A is a diagram of beam 310 from Figure 5C, and Figure 9B is a diagram of beam 610 from Figure 7E (and may be similar to beam 710 from the process outlined in Figures 8A-8C).

[0093]

[0100] The beam 310 has a pair of lateral surfaces 324, an inner arc length 320, and an outer arc length 322. As can be seen in FIG. 9A , the inner arc length 320 is shorter than the outer arc length 322. The beam 610 has a pair of side surfaces 624, an inner arc length 620, and an outer arc length 622. The inner and outer arc lengths 620, 622 are much closer in length to one another, with the inner arc length 620 being slightly longer than the outer arc length 622. In some embodiments, the ratio of the inner arc length 620 to the outer arc length 622 ranges from 1.2:1 (the inner arc length 620 is slightly longer than the outer arc length 622) to 6:1 (the inner arc length 620 is approximately six times longer than the outer arc length 622). In some embodiments, the ratio of inner arc length to outer arc length ranges from about 1.2:1 to 6:1, such as 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, 5.5:1, or a ratio within a range having endpoints defined by any two of the above values.

[0094]

[0101] Triple-pass and quadruple-pass cutting processes have also been surprisingly found to increase manufacturing efficiency and yield when compared to standard processes with a single pass per beam. Even when the number of blade passes is doubled or tripled using the disclosed methods, the multi-pass process requires a shallower depth per cut and typically produces more precise cuts. This has been surprisingly found to more than compensate for the additional time required to make multiple cuts per beam.

[0095]

[0102] In some embodiments, the cutting process(es) are governed by the length of each section of the micromachined cut pattern (e.g., the length of the proximal, central, and distal sections) and the degree of cutting distribution. For example, parameters related to length and degree may be stored in a software application executed by a computer system. Additionally and / or alternatively, the cutting process may be governed by a desired ratio between the inner arc length and the outer arc length. Furthermore, the cutting process may be governed by where each section of the micromachined cut pattern is located longitudinally along the elongated member. For example, a micromachined cut pattern located near the proximal end of the elongated member may include a one-cut, one-beam process, while a micromachined cut pattern located near the distal end of the elongated member may include a three-cut, one-beam process. [Example]

[0096]

[0103] Table 1 provides details regarding the outer arc length, inner arc length, and ratio of inner arc length to outer arc length for the disclosed beam configurations. In particular, Table 1 outlines the angular span and cut depth when forming each of the listed cuts. Table 1 also outlines the arc lengths and their respective ratios for the inner and outer arcs of each beam. The minimum and maximum arc lengths are a function of the inner and outer diameters of the stock material used to form the resulting structure. In Table 1, the "3cut-lbeam" cut type corresponds to the first cut pattern 120, the "2cut-2beam" cut type corresponds to the second cut pattern 122, and the "lcut-2beam" cut type corresponds to the third cut pattern 124 (see FIG. 3). The "ratio" is the ratio of the average inner arc length to the average outer arc length.

[0097] [Table 1]

[0098] Additional Terms and Definitions

[0104] While particular embodiments of the present disclosure have been described in detail with reference to particular configurations, parameters, components, elements, etc., the description is illustrative and is not to be construed as limiting the scope of the claimed invention.

[0099]

[0105] Furthermore, it should be understood that for any given element of a component of a described embodiment, any of the possible alternatives listed for that element or component may generally be used individually or in combination with one another, unless otherwise implicitly or explicitly stated.

[0100]

[0106] Additionally, unless otherwise indicated, numbers expressing quantities, components, distances, or other measurements used in the specification and claims are understood to be optionally modified by the term "about" or its synonyms. The terms "about," "approximately," "substantially," or the like, when used in connection with a stated quantity, value, or condition, may be considered to mean that the quantity, value, or condition deviates by more than 20%, less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% from the stated quantity, value, or condition. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0101]

[0107] Any headings and sub-headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims.

[0102]

[0108] 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 include two or more such referents.

[0103]

[0109] It will also be recognized that the embodiments described herein may include properties and / or characteristics (e.g., materials, components, members, elements, parts, and / or portions) described in one or more separate embodiments and are not necessarily limited to the precise features explicitly described for that particular embodiment. Accordingly, various features of a given embodiment may be combined with and / or incorporated into other embodiments of the present disclosure. As such, the disclosure of a particular feature for a particular embodiment of the present disclosure should not be construed as limiting the application or inclusion of such feature to the particular embodiment. Rather, it will be recognized that other embodiments may also include such features.

Claims

1. 1. An intravascular device for aspiration procedures, comprising: an elongated member including a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the elongated member including a plurality of perforations and a plurality of circumferentially extending rings forming a plurality of axially extending beams, each beam including an inner surface, an outer surface, and two lateral surfaces; An intravascular device, wherein at least one beam has an inner arc length to outer arc length ratio ranging from about 1.2:1 to about 6:

1.

2. The intravascular device of claim 1 , wherein the intravascular device is an aspiration catheter.

3. The intravascular device of claim 1 , wherein the elongated member includes a one-beam section with a single beam extending between each pair of adjacent rings.

4. The intravascular device of claim 3 , wherein the one-beam section is distal to a two-beam section having two beams extending between each pair of adjacent rings.

5. The intravascular device of claim 4 , wherein the two-beam section comprises two cut two-beam sections per beam.

6. The intravascular device of claim 5 , wherein the ratio of inner arc length to outer arc length for each beam of the two-beam section of the two cuts per beam is in the range of about 1.2:1 to about 6:

1.

7. The intravascular device of claim 5 , wherein the two-beam section further comprises one cut two-beam section per beam.

8. 8. The intravascular device of claim 7, wherein the ratio of inner arc length to outer arc length for each beam of the one-cut-per-beam two-beam section is less than about 1.2, or less than about 1.1, or less than about 1.

9. The intravascular device of claim 5 , wherein the one-cut-per-beam two-beam section is proximal to the two-cut-per-beam two-beam section.

10. The intravascular device of claim 3 , wherein the one-beam section comprises three one-beam sections per beam.

11. The intravascular device of claim 10, wherein the ratio of inner arc length to outer arc length for each beam of the three-cut one-beam section is in the range of about 1.2:1 to about 6:

1.

12. The intravascular device of claim 3 , wherein at least some of the beams in the one-beam section are rotated by about 100 degrees to about 150 degrees relative to adjacent beams.

13. 13. The intravascular device of claim 12, wherein each beam of the one-beam section is rotated relative to an adjacent beam by about 100 degrees to about 150 degrees, e.g., about 102.5 degrees to about 145 degrees, or about 105 degrees to about 140 degrees, or about 107.5 degrees to about 135 degrees, or about 110 degrees to about 130 degrees, or about 115 degrees to about 125, or about 120 degrees.

14. The intravascular device of claim 1 , further comprising a marker band disposed within a marker band channel, the marker band channel disposed at a distal tip at or near the distal end of the elongate member.

15. The intravascular device of claim 14 , wherein the marker band channel is grooved and has a depth such that an outer surface of the marker band is substantially flush with an outer diameter of the elongate member.

16. The intravascular device of claim 1 , further comprising one or more polymeric coatings disposed on an inner surface of the elongate member, an outer surface of the elongate member, or both.

17. 17. The intravascular device of claim 16, wherein the one or more polymer coatings comprise a plurality of different polymers, each having a different modulus and / or a different hardness.

18. The intravascular device of claim 17 , wherein the plurality of different polymers are disposed along the elongate member to contribute to a gradient flexibility profile.

19. The intravascular device of claim 1 , wherein the elongated member comprises nitinol.

20. The intravascular device of claim 1 , wherein the intravascular device omits a coil attached to the distal section of the elongate member and extending distally from the distal section through the distal end of the elongate member.

21. 1. A method of manufacturing an intravascular device for use in an aspiration procedure, comprising: providing a piece of stock material; advancing a blade into the stock material at a first longitudinal position to form a first cut in the stock material without completely penetrating the stock material, the blade being oriented so that a cutting edge is substantially perpendicular to a longitudinal axis of the stock material; rotating the stock material relative to the blade without longitudinally advancing the stock material relative to the blade; advancing the blade into the stock material to make a second cut; rotating the stock material relative to the blade a second time without advancing the stock material longitudinally relative to the blade; advancing the blade into the stock material to form a third cut; The method provides a single beam between adjacent rings at the first longitudinal position.

22. 22. The method of claim 21, wherein the blade is advanced into the stock material to the same depth for the first, second, and third cuts.

23. 22. The method of claim 21, further comprising longitudinally advancing the stock material to one or more additional longitudinal positions to form additional beams, and repeating the formation of cuts at each additional longitudinal position, each additional longitudinal position comprising a single beam between adjacent rings.

24. 1. A method of manufacturing an intravascular device for use in an aspiration procedure, comprising: providing a piece of stock material; advancing a blade into the stock material at a first longitudinal position to form a first cut in the stock material without completely penetrating the stock material, the blade being oriented so that a cutting edge is substantially perpendicular to a longitudinal axis of the stock material; rotating the stock material relative to the blade without longitudinally advancing the stock material relative to the blade; advancing the blade into the stock material to make a second cut; rotating the stock material relative to the blade a second time without advancing the stock material longitudinally relative to the blade; advancing the blade into the stock material to form a third cut; rotating the stock material relative to the blade a third time without advancing the stock material longitudinally relative to the blade; advancing the blade into the stock material to form a fourth cut; The method provides two beams between adjacent rings at the first longitudinal position.

25. 25. The method of claim 24, wherein the blade is advanced into the stock material to the same depth for the first, second, third, and fourth cuts.

26. 25. The method of claim 24, further comprising longitudinally advancing the stock material to one or more additional longitudinal positions to form additional beams, and repeating the formation of cuts at each additional longitudinal position, each additional longitudinal position including two beams between adjacent rings.

27. An intravascular device according to any one of claims 1 to 20, formed using a method according to any one of claims 21 to 26.

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