Microfabricated intravascular device for aspiration processes

Abstract

An intravascular device for use in aspiration procedures having desirable push capability, torque capability, flexibility, and toroidal strength characteristics is disclosed. The intravascular device employs a stacked configuration of micromachined cutting patterns, improving operability of the intravascular device during vasculature procedures. The intravascular device may also include a channel configured to receive the radiopaque marker to facilitate navigation and positioning of the intravascular device during the procedure.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit and priority of U.S. Patent Application No. 18 / 374,564, filed on September 28, 2023, entitled "MICROFABRICATED INTRAVASCULAR DEVICE FOR ASPIRATION PROCEDURES" and U.S. Provisional Patent Application No. 63 / 411,505, filed on September 29, 2022, entitled "MICROFABRICATED INTRAVASCULAR DEVICE FOR ASPIRATION PROCEDURES", the entire disclosure of each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to intravascular devices for navigating a patient's vasculature to a target location and, more particularly, to intravascular devices for aspiration procedures. Background Art

[0004] Intravascular devices, such as catheters, are often used in the medical field to perform delicate procedures deep within the human body. Typically, a catheter is inserted into a patient's femoral artery, radial artery, carotid artery, or jugular vein and navigated through the patient's vasculature to the heart, brain, or other target anatomical structure as needed. Generally, a guidewire is first guided to the target anatomical structure, and then one or more catheters are passed over the guidewire and guided to the target anatomical structure. Once in place, the catheter can be used to deliver drugs, stents, embolization devices, radiopaque dyes, or other devices or substances to treat the patient in a desired manner. For example, an intravascular device can be a catheter that is guided to a desired target anatomical structure and provides vacuum aspiration or suction.

[0005] In many applications, such intravascular devices must be angled through the tortuous bends and curves of the vasculature channels to reach the target anatomical structure. For example, guiding a catheter to a portion of the neurovasculature requires passing through the internal carotid artery and other tortuous paths. Such interventional devices need to be sufficiently flexible, especially closer to their distal ends, to navigate such tortuous paths.

[0006] 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 axial thrust to the distal end rather than bending and binding the intermediate section), and structural integrity for performing the intended medical function.

[0007] Regarding torque capabilities, as the length of the catheter entering and passing through the vasculature channel increases, the amount of frictional surface contact between the catheter and the vasculature tissue increases, impeding easy movement through the vasculature channel. Torque transmission from the proximal end to the distal end allows the catheter to rotate and overcome the frictional force, enabling further advancement and positioning.

[0008] In some cases, portions of the device are microfabricated to increase flexibility. For example, a catheter may include an outer elongate tube that includes a series of mechanically cut fenestrations near the distal end and sometimes at other locations. The incisions are typically arranged to define a series of axially extending "beams" that connect a series of circumferentially extending "rings".

[0009] While such microfabrication techniques are beneficial for increasing the flexibility of the elongate intravascular component, there are still several challenges. Most intravascular devices use coils at their distal ends to impart the desired flexibility characteristics and to avoid piercing or damaging the vasculature or the target anatomy. While these coils can provide flexibility, they exhibit poor circumferential strength (i.e., the ability to maintain the expected cross-sectional, circular shape) and tend to ovalize when a vacuum aspiration or suction is applied.

[0010] In addition, such coils tend to collapse and wrinkle like a "pleat" when pushed, meaning they may be more difficult to effectively navigate through the vasculature and small tortuous spaces. Such coils also tend to be made of stainless steel or other relatively rigid materials that have poor kink resistance, resulting in plastic deformation during sharp turns.

[0011] Intravascular devices can also utilize radiopaque markers disposed at the ends of the catheter to identify and locate the distal end of the catheter when the catheter is within the patient's vasculature. Such radiopaque markers are typically provided at the distal end of the catheter. However, these markers are difficult to secure and are generally difficult to attach to the distal end of the catheter. Thus, these markers are prone to detachment from the distal end of the catheter during procedures (such as when the catheter is removed from the patient's vasculature). The problem of losing radiopaque markers within the patient's vasculature is particularly significant during neurovascular procedures.

[0012] Accordingly, there has long been a need for improved intravascular devices and methods capable of manufacturing such devices. SUMMARY OF THE INVENTION

[0013] Disclosed are intravascular devices with a microfabricated outer surface, such as catheters and / or aspiration catheters. The disclosed intravascular devices have high flexibility at their distal ends while maintaining and retaining good torque capabilities and pushability for effective navigation in, for example, the neurovasculature. The disclosed intravascular devices also exhibit improved circumferential strength and thus effectively function as aspiration catheters.

[0014] In some embodiments, the intravascular device includes an elongated member that extends along a longitudinal axis between a proximal end and a distal end, wherein a lumen extends from the proximal end to the distal end. The elongated member includes a microfabricated outer surface that defines a plurality of axially extending beams and a plurality of circumferentially extending rings, wherein the microfabricated outer surface contributes to a flexibility gradient of the intravascular device. At least one beam includes an inner surface, an outer surface, and a pair of opposing side surfaces, wherein an angle is formed between the inner surface and one or both of the side surfaces. The inner surface and the outer surface of the beam each include an arc length, wherein the arc length of the outer surface can be equal to or less than the arc length of the inner surface. In some embodiments, the intravascular device is an aspiration catheter.

[0015] In some embodiments, one or more polymer layers are applied to the inner surface and / or the outer surface of the elongated member. In some embodiments, one or more polymer layers of different hardness and / or modulus are applied to different portions of the elongated member to correspond to the flexibility gradient of the underlying sections of the elongated member.

[0016] In some embodiments, the intravascular device includes a marker band channel at the most distal section or the distal end of the elongated member. The marker band channel is sized to accommodate a radiopaque marker band. The slotted marker band channel includes ridges at the proximal and distal ends of the channel. During operation of the intravascular device, the proximal ridge and the distal ridge hold the radiopaque marker in place. Additionally, the channel is slotted such that the radiopaque marker is at a depth substantially flush with the outer diameter of the outer surface of the intravascular device.

[0017] In some embodiments, the axial length of the channel is from about 0.01 to 0.03 inches, such as 0.019, 0.02, 0.025 inches, or a length within a range having endpoints selected from any two of the above values. In some embodiments, the thickness of the radiopaque marker is from about 0.0015 to 0.0025 inches. When the radiopaque marker has been set and fixed in the channel, the radiopaque marker is substantially flush with the outer diameter of the intravascular device. An adhesive can be wicked between the radiopaque marker and the marker band channel to further mechanically secure the radiopaque marker within the channel.

[0018] In one embodiment, a method of manufacturing an intravascular device including a "single beam" configuration includes the steps of: providing a piece of raw material; inserting a blade into the raw material at a certain cutting depth to form a first incision in the raw material without completely passing through the raw material, the blade being oriented such that the cutting edge is substantially perpendicular to the longitudinal axis of the raw material; rotating the raw material relative to the blade without longitudinally advancing the raw material relative to the blade; inserting the blade into the raw material to form a second incision; rotating the raw material relative to the blade a second time without longitudinally advancing the raw material relative to the blade; inserting the blade into the raw material to form a third incision, inserting the blade into the raw material to form a third incision, wherein the blade is inserted into the raw material at the same incision depth as the first incision to form the second and third incisions.

[0019] In some embodiments, the proximal section of the disclosed intravascular device includes a hub or handle equipped with vacuum aspiration / suction capabilities. For example, when the disclosed intravascular device is guided to a target anatomical structure, the vacuum hose in the hub can be opened, or vacuum can be applied to the catheter in other ways to provide vacuum aspiration at the target anatomical structure. Such vacuum aspiration can remove, for example, clots, emboli, and / or other blockages at the target anatomical structure.

[0020] In some embodiments, the outer surface of the microfabricated components of the intravascular device includes a plurality of incisions (or fenestrations). In some embodiments, a plurality of different incision patterns are arranged to provide a flexible profile or gradient. The plurality of incision patterns can include a first incision pattern that can be different from a second incision pattern, and the second incision pattern can be different from a third incision pattern. In some embodiments, the arrangement of the incision patterns involves rotation of the second incision pattern relative to the first incision pattern, and rotation of the third incision pattern relative to the second incision pattern, and / or rotation of a beam or group of beams relative to other beams or groups of beams.

[0021] In some embodiments, the third incision pattern includes a double-beam arrangement formed via a one-cut-per-beam manufacturing process (i.e., two incisions form each double-beam section). In some embodiments, the second incision pattern includes a double-beam arrangement formed via a two-cut-per-beam manufacturing process (i.e., four incisions to form each double-beam section). In some embodiments, the first incision pattern includes a single-beam arrangement formed via a three-cut manufacturing process. In some embodiments, the first incision pattern is distal to the second incision pattern, and the second incision pattern is distal to the third incision pattern.

[0022] Beams of various arrangements (e.g., single beam, double beam, 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 beams, the ratio of the first arc length to the second 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. The ratio and length of the first arc length and the second arc length can be controlled and / or affected by the method of manufacturing the intravascular device.

[0023] Unlike conventional catheters, the disclosed intravascular devices do not require a distally extending outer coil to provide desired characteristics to the catheter, such as the flexibility characteristics of the catheter. Instead, the desired characteristics (e.g., pushability, torqueability, and flexibility) and the flexibility gradient are imparted to the elongate element itself via the microfabricated notch pattern and their stacked arrangement along the longitudinal axis of the elongate element. The microfabricated notch pattern can also work in conjunction with a polymer coating to provide an effective flexibility profile. Additionally, the desired characteristics are imparted via the materials used to construct the intravascular device. For example, in some embodiments, the disclosed intravascular device is constructed of nitinol and / or another suitable alloy.

[0024] The combination of the microfabricated notch pattern and the use of nitinol to form the disclosed intravascular device provides several benefits.

[0025] First, compared to devices having a coil as the main distal structural member, the elongate member with the microfabricated notch pattern imparts greater circumferential strength to the intravascular device. Circumferential strength refers to the ability of the device to maintain an expected circular cross-sectional shape. High circumferential strength indicates a greater ability to maintain the expected circular cross-section, which is particularly important in aspiration applications. Low or weak circumferential strength means that the expected circular cross-sectional shape may not be maintained, which means that when subjected to vacuum forces or other deforming forces, the cross-sectional shape of the catheter tends to become elliptical more easily. Elliptization (e.g., deformation of the circular shape along the axis) changes the functional circumference or diameter of the intravascular device and can pose an obstacle to effectively removing clots or other obstructions. The disclosed intravascular device provides effective circumferential strength and can therefore effectively and safely remove clots, emboli, and other targets from the patient's vasculature. The effective removal is at least partially due to the intravascular device enhancing the ability to maintain the desired cross-sectional shape.

[0026] Second, the disclosed intravascular device with a microfabricated cut pattern effectively transmits torque along the length of the intravascular device (i.e., provides good torqueability), and effectively transmits thrust along the length of the catheter (i.e., provides good pushability). The microfabricated cut pattern enables the elongate member to have torqueability and propulsion ability without the need for coils as the main external structural components, while still maintaining a desired flexible profile / gradient along the longitudinal axis of the device. That is, the microfabricated elongate element 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 element. Instead, the distal end of the elongate member itself represents the distal end of the device.

[0027] 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 to limit the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various objects, features, characteristics, and advantages of the present invention will become apparent and more readily understood from the following description of embodiments in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification. In the drawings, like reference numerals may be used to designate corresponding or similar parts in the respective drawings, and the various elements depicted are not necessarily drawn to scale, wherein:

[0029] Figure 1 and Figure 2 show an exemplary embodiment of an intravascular device with microfabricated components;

[0030] Figure 3 show the distal or distal section of an exemplary intravascular device with microfabricated components;

[0031] Figure 4 show a close-up view of the distal end of an exemplary intravascular device;

[0032] Figures 5A - 5C show a typical cutting process for forming a single-beam cut pattern in a piece of raw material and the structure of the beam produced by a standard cutting process;

[0033] Figures 6A - 6C show an alternative cutting process and an improved structure of the beam produced by the alternative cutting process;

[0034] Figures 7A - 7E show another alternative cutting process for a double-beam cut pattern and the structure of the beam produced by the alternative cutting process;

[0035] Figures 8A - 8C show another alternative cutting process; and

[0036] Figures 9A - 9B Shows a comparison of beams produced by a typical cutting process and an alternative cutting process. Detailed Description

[0037] Disclosed is an intravascular device with microfabricated components. In some embodiments, the intravascular device includes an elongate member that extends along a longitudinal axis between a proximal end and a distal end, wherein a lumen extends through the elongate member from the proximal end to the distal end. The elongate member includes microfabricated components that define a plurality of axially extending beams and a plurality of circumferentially extending rings. The beams include an inner surface, an outer surface, and a pair of side surfaces. In some embodiments, the intravascular device is an aspiration catheter. Although some of the examples described herein include references to a particular type of intravascular device (e.g., an aspiration catheter), it will be understood that the same components, methods, and principles can be applied to other types of intravascular devices, such as other types of catheters and / or guidewires.

[0038] In some embodiments, a polymer layer or coating is applied to the inner surface and / or outer surface of the elongate member. In some embodiments, the disclosed intravascular device includes a marker band channel in the most distal section of the intravascular device. The marker band channel is sized to accommodate a radiopaque marker. The slotted marker band channel includes ridges at the proximal and distal ends of the channel. The ridges advantageously hold the radiopaque marker in place during operation of the device. Additionally, the channel is slotted such that the radiopaque marker is substantially flush with the outer diameter of the elongate member at adjacent sections of the elongate member.

[0039] In one embodiment, a method of manufacturing an intravascular device having a single beam section includes the steps of: providing a piece of raw material; inserting a blade into the raw material to form a first cut in the raw material without completely passing through the raw material, the blade being oriented such that the cutting edge is substantially perpendicular to the longitudinal axis of the raw material; rotating the raw material relative to the blade without advancing the raw material longitudinally relative to the blade; inserting the blade into the raw material to form a second cut; rotating the raw material a second time relative to the blade without advancing the raw material longitudinally relative to the blade; and inserting the blade into the raw material to form a third cut.

[0040] In some embodiments, the proximal section of the disclosed intravascular device includes a hub or handle equipped with vacuum aspiration capabilities. For example, when the disclosed intravascular device is guided to a target anatomical structure, the vacuum hose in the hub can be opened or vacuum can otherwise be applied, thereby providing vacuum aspiration at the target anatomical structure. Such vacuum aspiration can remove, for example, clots and / or other obstructions at the target anatomical structure.

[0041] In some embodiments, the microfabricated outer surface includes a plurality of notch patterns. In some embodiments, the notch patterns are arranged to have a first notch pattern that is different from a second notch pattern, and the second notch pattern is different from a third notch pattern. In some embodiments, the third notch pattern includes a double-beam arrangement formed via a single-cut-per-beam manufacturing process (i.e., two cuts form two beams between each set of loops). In some embodiments, the second notch pattern includes a double-beam arrangement formed via a double-cut-per-beam manufacturing process (i.e., four cuts form two beams between each set of loops). In some embodiments, the first notch pattern includes a single-beam pattern formed via a triple-cut manufacturing process (i.e., three cuts form a single beam between each set of loops).

[0042] Each beam in the various arrangements includes an inner surface having a first arc length and an outer surface having a second arc length, where the ratio of the lengths of the first arc length and the second arc length (i.e., the ratio of the inner arc length to the outer arc length) is in the range of from about 1.2:1 to 6:1. The ratio and lengths of the first arc length and the second arc length can be controlled and / or affected by the method of manufacturing the intravascular device.

[0043] Unlike conventional catheters, the disclosed intravascular devices do not use distally extending coils as the primary external structural components to provide desired characteristics to the catheter, such as flexibility. Instead, the desired characteristics (e.g., pushability, torqueability, and flexibility) are imparted (at least in part) to the elongate member itself via the microfabricated notch patterns and their arrangement along the longitudinal axis of the disclosed intravascular device. Additionally, the desired characteristics are influenced or imparted via the materials used to construct the intravascular device. For example, in some embodiments, the disclosed intravascular device is constructed of nitinol and includes one or more polymer coatings that are selected and arranged to contribute to forming a desired flexible profile.

[0044] Overview of Intravascular Device

[0045] Figure 1 and Figure 2 An exemplary intravascular device 100 is shown, including an elongate member 104 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 can be in the range from about 0.010 inches to 0.050 inches, such as 0.017 inches to 0.04, 0.019, 0.02, 0.025, 0.03, 0.035, 0.037, 0.038, 0.039 inches, or the inner diameter is within a range defined by any two of the above values. The outer diameter of the intravascular device can be in the range from about 0.04 inches to 0.06 inches, such as 0.045, 0.047, 0.049, 0.051, 0.053, 0.055, 0.057 inches, or an outer diameter within a range defined by any two of the above values.

[0046] The intravascular device 100 includes an open lumen to enable aspiration of clots or other obstructions, for example, from a patient's vasculature. An optional handle / hub / torquer 102 may be attached at the proximal end 106. Figure 1 The hub 102 is configured as a handle to be actively grasped by a practicing physician; Figure 2 The hub 102 is configured as a handle with paddles that provide additional stability during use of the intravascular device 100.

[0047] The elongate member 104 may be formed of or include a tube structure. The elongate member 104 may include a microfabricated outer surface that may include a plurality of cut patterns or fenestrations cut into its outer surface. The plurality of fenestrations may be cut into the outer surface of a proximal section, a distal section, and / or along a longitudinal axis (i.e., a middle or intermediate section) extending therebetween. The fenestrations may be formed by cutting one or more pieces of raw material to form a cut pattern that leaves the fenestrations. The fenestrations can provide a variety of benefits, including increasing the flexibility of the elongate member 104. Additionally, the fenestrations may be arranged to provide a flexibility gradient along the longitudinal axis of the intravascular device. In some embodiments, the fenestrations are arranged to provide enhanced flexibility (relative to a similar raw material section without fenestrations) while maintaining sufficient peripheral structure for effective torque transmission.

[0048] The elongate member 104 may be any necessary length for navigating through a patient's anatomy to reach a target anatomical region. Typical lengths may range, for example, from about 50 to 300 cm. In a catheter embodiment, the outer diameter of the elongate member 104 may range from about 0.020 inches to about 0.350 inches, such as from about 0.04 inches to about 0.150 inches, but larger or smaller diameters may also be used depending on preference and / or application requirements.

[0049] In some embodiments, the elongate member 104 comprises or is formed of a nickel-titanium alloy having superelastic properties at body temperature. The elongate member 104 may alternatively or additionally be formed of a material having a modulus of elasticity of about 3000 MPa to about 4500 MPa, or about 3500 MPa to about 4000 MPa. In one embodiment, the elongate member 104 is formed of or includes polyetheretherketone (PEEK). Other polymers with higher moduli may also be used where cost and / or manufacturing considerations warrant. Additionally or alternatively, the elongate member 104 may include stainless steel.

[0050] The most distal section of the disclosed intravascular device includes a marker band channel or groove that is configured to receive a radiopaque marker and hold the marker in place. Figure 4 Describe the marker band channel more fully.

[0051] Figure 3 A close-up view of the elongate member 104 is shown. The break (shown by the dashed line) between the proximal section 107 and the distal section 109 represents the continuous elongate member 104 extending between the proximal section 107 and the distal section 109. The elongate member 104 includes a plurality of different microfabricated notch patterns. The distal section 109 shown includes a first microfabricated notch pattern 120, a second microfabricated notch pattern 122, a third microfabricated notch pattern 124, and a marker band channel 126. The proximal section 107 may also include one or more microfabricated notch patterns. For example, the third microfabricated notch pattern 124 may extend to the proximal section 107.

[0052] In some embodiments, the third microfabricated notch pattern 124 is a single cut per beam double beam section. In some embodiments, the second microfabricated notch pattern 122 is a double cut per beam double beam section. In some embodiments, the first microfabricated notch pattern 120 is a three-cut-per-beam single beam section. These configurations will be described in more detail below. Each section of the microfabricated notch pattern transitions to the next section of the microfabricated notch pattern; thus, each section of the microfabricated notch pattern may include a transition section.

[0053] The arrangement of the first microfabricated notch pattern, the second microfabricated notch pattern, and the third microfabricated notch pattern creates a "stacked" configuration and contributes to or forms a gradient flexible profile. The gradient provides the desired flexibility, pushability, and torqueability characteristics for the effective and safe operation of the disclosed intravascular device. For example, the stacked arrangement is configured to impart effective column strength along the proximal section of the intravascular device while sufficiently reducing the column strength at the distal section. Minimizing the column strength at or near the distal end of the device imparts greater flexibility or "stretchability" at the distal end. This flexibility means that the intravascular is less likely to pierce tissue or blood vessels if contacted during navigation to the target anatomy. Instead, when resistance is encountered from the target anatomy, the distal end of the intravascular device will tend to flex or bend. Thus, the distal section 109 is capable of safely bending while still maintaining the desired shape and diameter, for example, during an aspiration procedure.

[0054] Figure 4A close-up view of the distal region of the elongated member 104 including the marker band channel 126 is shown. The marker band channel 126 is configured to receive markers, which may be radiopaque markers to assist in the positioning and guidance of intravascular devices. In some embodiments, the markers are made of tantalum or another suitable radiopaque material. In some embodiments, an adhesive is applied between the marker and the marker band channel 126 to hold the marker in place within the channel 126. In some embodiments, the marker band channel 126 includes a proximal ridge at the proximal section of the channel 126 and a distal ridge at the most distal section of the channel 126. In some embodiments, the intravascular device 100 extends just beyond the distal ridge. This extension may be chamfered (e.g., at approximately 45°) to assist in non-invasively navigating through the patient's vasculature.

[0055] The chamfered extension may have a distance or extension D2 of approximately 0.001 to 0.0035 inches. In some embodiments, the chamfered extension is approximately 0.002 inches. The lumen may have a diameter D1 of approximately 0.030 to 0.040 inches. For example, in some embodiments, the lumen may have a diameter D1 of approximately 0.038 inches. The elongated member 104 may have a wall thickness (including the liner) of approximately 0.0030 to 0.0050 inches.

[0056] Advantageously, the proximal and distal ridges of the channel 126 hold the markers in place during, for example, removal of the disclosed intravascular device 100 from the patient's vasculature. Thus, the markers do not pry loose from the intravascular device 100 and become lost within the patient's vasculature. This problem is of particular concern when navigating through the tight vasculature of the brain. The disclosed intravascular device 100 addresses this problem by holding the markers in place and securing them within the channel 126. Additionally, the marker band channel 126 is slotted such that when the radiopaque marker is disposed within or on the channel 126, the outer diameter of the 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 the channel 126. An adhesive or glue may be applied to the marker and around the marker, such as at the junction where the two ends of the C meet. The adhesive may capillary between the marker and the channel 126, thereby further securing the marker to the channel.

[0057] In some embodiments, the length of the marker band channel 126 is from approximately 0.020 inches to 0.045 inches, such as from about 0.025 inches to 0.040 inches, or the length is within a range defined by any two endpoints of the above values.

[0058] Microfabricated incision pattern

[0059] The disclosed intravascular device includes a micromachined notch pattern. In addition to the embodiments described herein, examples of various micromachined notch patterns that can be used are illustrated and described in U.S. Application Publications 2020 / 0345975 and 2018 / 0177517, the entire content of each of which is incorporated herein by reference.

[0060] In some embodiments, the micromachined notch pattern includes a plurality of beams (axially extending segments remaining after cutting) and rings (circular, circumferentially extending segments disposed between each set of notches). The micromachined notch pattern can include at least one single-beam arrangement and a double-beam arrangement. The single-beam arrangement includes a single beam disposed between each pair of adjacent rings. The double-beam arrangement includes two beams disposed between each pair of adjacent rings. Other embodiments can include sections with other arrangements, such as a triple-beam section having three beams between each pair of adjacent rings.

[0061] 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 a preferred bending axis. For example, an angular offset can be applied at each notch location or every few notch locations (e.g., every two, every three, etc.) to deliberately rotate the resulting beam positions to minimize the formation of a preferred bending axis.

[0062] In some embodiments, the micromachined notch pattern is arranged to provide enhanced flexibility (relative to a similar section of raw material lacking fenestrations) while maintaining sufficient peripheral structure to effectively transmit torque. For example, starting at the most distal end of the intravascular device, a single-beam arrangement can be followed proximally by a double-beam arrangement, which can be followed by another double-beam arrangement that extends to the proximal end of the intravascular device.

[0063] In some embodiments, the disclosed intravascular device includes a third micromachined notch pattern in an approximately proximal section, a second notch pattern in an intermediate section between the proximal and distal sections, and a first notch pattern in an approximately distal section. In some embodiments, the third micromachined notch pattern includes a double-beam arrangement formed via a conventional single cut per beam process. In some embodiments, the second micromachined notch pattern includes a double-beam arrangement formed via a double cut per beam process (outlined in more detail below). In some embodiments, the first micromachined notch pattern includes a single-beam arrangement formed via a triple cut per beam process (outlined in more detail below).

[0064] In some embodiments, the third micromachined cut pattern extends distally along the longitudinal axis from the hub or handle (attached to the intravascular device at its proximal most end) for about 60 cm to 180 cm, such as about 100 cm to 160 cm or a range using any combination of the foregoing as endpoints. In some embodiments, a strain relief attachment is provided between the distal end of the hub or handle and the proximal end of the proximal section of the intravascular device.

[0065] In some embodiments, the second cut pattern extends distally along the longitudinal axis of the intravascular device from the distal end of the third cut pattern. 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 from about 4 cm to 12 cm, or from about 5 cm to about 10 cm, or from about 6 cm to about 7 cm, or a length within a range defined by any two of the foregoing values. The distal end of each micromachined cut pattern may include a transition section to smoothly transition from one micromachined cut pattern to the next.

[0066] In some embodiments, the first cut pattern extends distally along the longitudinal axis of the intravascular device 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 (as described above). In some embodiments, the length of the first cut pattern is from about 1 cm to 5 cm, or from about 1.5 cm to about 4 cm, or from about 2 cm to about 3 cm, or a length within a range defined by any two of the foregoing values.

[0067] The arrangement of the first, second, and third micromachined cut patterns creates a "stacked" configuration that contributes to a gradient of the cut patterns. The gradient provides the desired flexibility, pushability, and torqueability characteristics for effective and safe operation of the disclosed intravascular device. For example, the stacked arrangement is configured to impart a certain column strength along the proximal section of the intravascular device while minimizing the column strength at the distal section / end. Minimizing the column strength at or near the distal end of the device imparts greater flexibility or "give" at the distal end. This flexibility means that during navigation to the target anatomy, when the intravascular device hits tissue or a blood vessel, the intravascular device will not pierce the tissue or blood vessel. Instead, when resistance is encountered from the target anatomy, the distal end of the intravascular device will fold or bend.

[0068] In some embodiments, the intravascular device includes one or more polymer coatings. The polymer coating can be applied to the outer surface of the elongate member with the micromachined cut pattern. Additionally or alternatively, the polymer coating can be applied to the inner surface of the intravascular device under the micromachined cut pattern.

[0069] An intravascular device can include multiple polymer coatings, each with a different hardness / hardness value and / or modulus. The application of these polymer coatings creates a gradient in the hardness and / or modulus of the coatings. In some embodiments, the gradient of the coatings can correspond to the gradient of a micromachined notch pattern. This matching can enhance the desired properties of the device and ensure the retention of the desired properties (e.g., flexibility, pushability, and / or torqueability).

[0070] The disclosed intravascular device (e.g., aspiration catheter) can be constructed from a raw material. Such raw material can include, for example, a suitable medical-grade catheter material such as polyetheretherketone (PEEK), polyether block amide (PEBA), other polymers, nitinol, stainless steel, radiopaque materials, and / or combinations thereof. In some embodiments, the elongate member is composed of nitinol stock.

[0071] Compared to conventional aspiration catheters, the disclosed intravascular device does not use a coil extending distally from a hypotube, but instead relies on a gradient of a micromachined notch pattern along the longitudinal axis of the intravascular device to provide a balance of strength and flexibility. In situations where a coil is typically used to reduce column strength and increase flexibility, such a coil has suboptimal hoop strength and is prone to ovalizing when a vacuum is applied. In contrast, for example, the pattern of the first micromachined notch 124 (which is the most distal notch 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. Since the micromachined notch pattern of the intravascular device is provided along the longitudinal axis and creates a gradient of strength and flexibility, different sections of the intravascular device can be "tuned" to obtain a desired strength and / or flexibility profile.

[0072] Notch pattern formation

[0073] Figures 5A - 5C A typical process for forming a single-beam notch pattern in a piece of raw material 302 is shown. The raw material 302 (typically a tube structure) is positioned in a cutting machine having a blade 304 (or blades). As shown by arrow 306, the blade 304 can be moved along an axis perpendicular to the longitudinal axis of the raw material 302 to form a window 303. Although the blade 304 is shown here as moving up and down along a vertical axis, other configurations can have a blade (or blades) that move along a horizontal axis or even a diagonal axis.

[0074] To effect the cut, the blade 304 is brought into contact with the starting material 302 and moved inwardly until the cut is made at a desired depth, and a beam 310 is created in the starting material 302. The blade 304 is then withdrawn from the starting material 302. The starting material 302 is then longitudinally moved relative to the blade 304, as indicated by arrow 308, until the next desired cut location is aligned with the blade 304. The process can then be repeated to form the desired number of cuts.

[0075] The depth of the cut and / or the spacing between cuts can 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 can include relatively deeper and / or relatively smaller spaced cuts to increase the relative flexibility at the distal portion.

[0076] In some embodiments, the starting material 302 can be rotated between successive cuts or between successive groups of cuts to allow for a rotational offset to be created in the beam, as indicated by arrow 312. Other details related to the cutting machine and associated manufacturing methods are described in U.S. Patent No. 10,232,141, the entire content of which is incorporated herein by reference.

[0077] Figure 5B and Figure 5C is shown in more detail the structure of the beam 310 produced by Figure 5A the standard cutting process shown. Figure 5B shows a cross-sectional view of the starting material 302 along a line parallel to the blade path of a particular cut, and Figure 5C shows an enlarged view of the edge section of the resulting beam 310. As shown, the blade 304 typically has a diameter significantly larger than that of the starting material 302 (e.g., a typical blade diameter can range from 2 inches to 4 inches). Figure 5B shows the blade 304 at the deepest point within the starting material 302. After the blade 304 is withdrawn, the resulting beam 310 remains.

[0078] As Figure 5C shown, the ultimately resulting beam 310 includes an inner surface 320, an outer surface 322, and two side surfaces 324 ( Figure 5C only one is shown in). Each side surface 324 is connected to the inner surface 320 along an inner edge 326, and to the outer surface 322 along an outer edge 328. An angle 330 is formed at the junction of the inner surface 320 and the side surface 324.

[0079] Due to the geometry of the cut, angle 330 is significantly greater than 90 degrees and typically about 135 degrees. As a structural result of the size of angle 330, the inner arc length along the inner surface 320 is less than the outer arc length along the outer surface 322. Similarly, although the beam 310 has a substantially uniform radial thickness over most of its circumferential length (as represented by the radial line 332a), the radial thickness gradually decreases between the inner edge 326 and the outer edge 328 (as represented by the progressively shorter radial lines 332b and 332c). Another structural result is that the edge 328 will be relatively "sharp". That is, the angle 331 formed between the side surface 324 and the outer surface 322 will be relatively small, such as about 45 degrees or less.

[0080] Enhanced cut pattern formation

[0081] Per-beam double cut process for single beam construction

[0082] Figures 6A to 6B An alternative method for forming a beam 410 in a section of raw material 402 is shown. As Figure 6A shown, the blade 404 first penetrates into the raw material 402 to a depth that is relatively short compared to the Figure 5B standard cut shown. For example, where the standard cut shown typically has a depth of about 70% or more of the raw material diameter, Figure 5B the initial cut depth shown is about 50% (e.g., about 30% to about 70%). Figure 6A

[0083] After the initial cut is formed, the raw material 402 is rotated relative to the blade 404 to allow the blade 404 to penetrate into the raw material 402 a second time, as Figure 6B shown. The raw material 402 remains in the same longitudinal position relative to the blade during the first and second penetrations of the blade 404 such that the second cut is in the same plane as the first cut. During the first cut, a first side surface 424a is formed and a temporary side surface 424c is formed. Then the second cut removes the temporary side surface 424c and cuts additional material to form a second side surface 424b.

[0084] Although the illustration shows a clockwise rotation of the blade 404 relative to the raw material 402 from the Figures 6A to 6B order given, it should be understood that this is for illustrative convenience only and any suitable manner of relative rotation between the raw material 402 and the blade 404 can be used by rotating the blade 404, the raw material 402, or both. Typically, the raw material 402 will be rotated relative to the 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).

[0085] ​Figure 6C An enlarged view of the edge section of the resulting beam 410 is shown. The resulting beam 410 includes an inner surface 420, an outer surface 422, and a pair of side surfaces 424 (a single side surface 424b is shown here). Each side surface 424 is connected to the inner surface 420 along an inner edge 426 and to the outer surface 422 along an outer edge 428. An angle 430 is formed at the junction of the inner surface 420 and the side surface 424.

[0086] Compared with Figure 5C the angle 330 of the beam 310 shown, the angle 430 of the beam 410 is significantly smaller. For example, the angle 430 can have a value within a range having a lower endpoint of about 75, 80, 85, or 90 degrees and an upper endpoint of about 130, 120, 110, or 100 degrees. For example, the angle 430 can be about 90 degrees such that the side surface 424b is substantially perpendicular to the inner surface 420.

[0087] 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 Figure 6C and Figure 5C , it can be seen that Figure 6C the ratio of the inner arc length to the outer arc length in the embodiment of Figure 5C is higher than that in the embodiment of Figure 6C , although even in the embodiment of

[0088] the outer arc length is still longer than the inner arc length.

[0088] The structure of the beam 410 provides a significant improvement over the standard beam 310. For example, the beam 410 avoids the "sharp" outer edge 428 present in the standard beam 310. In other words, the angle 431 formed between the side surface 424b and the outer surface 422 is greater than 45 degrees, such as from about 50 degrees to about 90 degrees.

[0089] Surprisingly, compared with the standard single-pass process, the double-pass cutting process improves manufacturing efficiency and throughput. Even though the number of blades passed through is doubled, the double-pass process requires less depth per cut and typically forms a more precise cut. It has been found that this more than compensates for the additional time required for two cuts per beam. In addition, using a shorter cut depth extends the life of the cutting blade.

[0090] In some embodiments, the cutting process is controlled by the length of each section of the microfabricated cut pattern (e.g., the lengths of the proximal, middle, and distal sections) and the degree of cutting distribution. For example, the parameters related to the length and degree can be stored in a software application to be executed by a computer system. Additionally and / or alternatively, the cutting process can be controlled by the desired ratio between the inner arc length and the outer arc length.

[0091] Double-cut per beam process for dual-beam construction

[0092] Also shown is a four-cut process (two cuts per beam) for forming a dual-beam configuration. Figures 7A - 7D A four-cut process for forming a dual-beam configuration is shown, where each beam is formed by two cuts (sometimes referred to herein as a "dual-cut dual-beam configuration per beam"). The resulting beams can be substantially the same size and have substantially the same ratio of inner to outer arc lengths.

[0093] As shown, the blade 604 first penetrates into the raw material 602 to a depth that is relatively short compared to the Figure 5B standard cut shown. For example, in Figure 5B a case where the standard cut shown typically has a depth of about 70% or more of the diameter of the raw material, Figure 7A the initial cut depth shown is approximately 25% (e.g., from about 15% to about 35%).

[0094] After the initial cut is formed, the raw material 602 rotates relative to the blade 604 between the additional channels through which the blade 604 penetrates into the raw material 602, as Figures 7B - 7D shown. The raw material 602 maintains the same longitudinal position relative to the blade during the first and second penetrations of the blade 604, such that the second cut is in the same plane as the first cut. Note that Figures 7A - 7D the specific order shown in Figure 7A is only an example. The relative rotation between the blade 604 and the raw material 602 can follow different orders depending on the direction of rotation and can alternatively follow, for example, the order of Figure 7C 、 Figures 7D to 7B .

[0095] Although the order from Figures 7A to 7D gives the appearance of the blade 604 rotating (e.g., clockwise) relative to the raw material 602, it should be understood that this is only for illustrative convenience and that any suitable manner of relative rotation between the raw material 602 and the blade 604 can be used by rotating the blade 604, the raw material 602, or both. Typically, the raw material 602 will rotate relative to the stationary blade 604.

[0096] When the next pair of beams is formed at the next longitudinal position of the elongate member, the raw material can be rotationally offset by a certain amount. For example, the raw material can be rotated 90 degrees relative to the previous pair of beams. This results in each pair of beams being offset 90 degrees from the previous pair of beams. Advantageously, axially rotating each pair of beams or every few pairs of beams (e.g., every two pairs, every three pairs, etc.) along the length of the raw material can minimize the plane in which preferential bending forms.

[0097] The process of linearly translating and rotating the raw material to form the beams can be repeated as many times as needed to achieve the desired length of the dual-beam section.

[0098] Also advantageously, the disclosed four-cut process produces a more desirable beam cross-sectional shape. As Figure 7E shown, the resulting beam shape avoids flat and / or sharp artifacts or edges that tend to concentrate stress and reduce the fatigue life of the device. Due to the four-cut process, the outer arc length of the beam (i.e., the arc length of the outer surface of the beam) will be equal to or even shorter than the inner arc length. This shape advantageously reduces the "sharp" corners of the outer edge (e.g., see the outer edge 328 in Figure 5C ), which tend to concentrate mechanical stress and reduce the fatigue life of the device. As Figure 7E shown, the cross-sectional shape of the beam can also reduce stiffness relative to a similar beam (i.e., a beam having the same cross-sectional area) with a greater difference between the outer arc length and the inner arc length.

[0099] Three-cut process per beam for single-beam construction

[0100] Also shown is a three-cut process for forming a single-beam construction or arrangement. As Figures 8A - 8C shown, the blade 704 first penetrates into the raw material 702 to a depth that is relatively short compared to the standard cut shown in Figure 5B . For example, in the case where the standard cut shown in Figure 5B typically has a depth of about 70% or more of the diameter of the raw material, the initial cut depth shown in Figure 8A is about 50% (e.g., about 30% to about 70% of the diameter of the raw material, typically not greater than about 50% of the diameter of the raw material). Note that the specific sequence shown in Figures 8A - 8C is only an example. The relative rotation of the blade 704 and the raw material 702 between the cuts can follow different sequences depending on the direction of rotation and can alternatively follow, for example, the sequences shown in Figure 8B , Figures 8A to 8C .

[0101] After forming the initial cut, the raw material 702 can be rotated relative to the blade 704 to allow the blade 704 to penetrate into the raw material 702 a second time, as Figure 8B shown. The raw material 702 remains in the same longitudinal position relative to the blade during the first and second penetrations of the blade 704 such that the second cut is in the same plane as the first cut. During the first cut, a first side surface and a first temporary side surface are formed, similar to the side surfaces 424A and 424B shown in Figures 6A - 6B . Then, the second cut removes the temporary side surface and cuts additional material to form the side surface of the beam. The raw material 702 can be rotated again, and the blade 704 penetrates into the raw material 702 a third time. The third cut removes additional material to form the opposite side surface of the resulting beam 710.

[0102] Although from Figures 8A to 8CThe order gives the appearance of the blade 704 rotating clockwise relative to the raw material 702, but it should be understood that this is for illustrative convenience only, and any suitable manner of relative rotation between the raw material 702 and the blade 704 can be utilized by rotating the blade 704, the raw material 702, or both. Typically, the raw material 702 will rotate relative to the stationary rotating blade 704.

[0103] As with other cutting method embodiments described herein, the process of rotating the raw material between cuts and then longitudinally / linearly translating the raw material can be repeated as many times as needed to achieve the desired length of a single-beam arrangement. The relatively short cutting depths used in this method, as compared to conventional single cuts per beam and even double cuts per beam for beam sections, enable an extended life for the cutting blade. Additionally, the three cuts per beam process is particularly suitable for larger diameter devices, such as the disclosed aspiration catheter device having an inner diameter of approximately 0.035 inches or other dimensions disclosed herein.

[0104] Also beneficial is that the disclosed three cuts process produces a more desirable beam cross-sectional shape. The resulting beam shape avoids flat and / or sharp artifacts or edges that tend to concentrate stress and reduce the fatigue life of the device. Due to the three cuts process, the outer / lateral arc length (i.e., the arc length of the outer surface of the beam) will be equal to or shorter than the inner arc length. This shape advantageously reduces the "sharp" corners of the outer edge (e.g., see the outer edge 328 in Figure 5C ), which tend to concentrate mechanical stress and reduce the fatigue life of the device. The resulting beam cross-sectional shape is also capable of reducing stiffness relative to similar beams (i.e., beams having the same cross-sectional area) that have a greater difference between the outer arc length and the inner arc length.

[0105] As described above, beams of any configuration described herein can be rotated from one longitudinal cutting position to the next to avoid or minimize alignment of the beams along the longitudinal axis, which alignment creates a preferred bending plane. For example, aligning all the beams of a single beam section along one side would result in a preferred bending direction along the "ridge" of the aligned crossbeams. While this may be desirable in some applications, typically it is more preferred that the device bend equally easily in any direction. "Rotation offset" refers to the amount of rotation of a beam or group of beams from one longitudinal position to the next. For example, in a single beam configuration, a series of cuts can be made at a first longitudinal position to form a first beam at an arbitrary 0° position. Then, the raw material can be linearly / longitudinally moved relative to the cutting blade to a second longitudinal position. Cuts are 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 cuts are made longitudinally down the raw material to form successive beams.

[0106] It has surprisingly been found that in a single beam configuration, a rotational offset of from about 100 degrees to about 150 degrees advantageously minimizes the column strength of corresponding sections of the elongated member and thus minimizes the buckling force required to cause bending under compressive loads of the column. Minimizing the buckling force is particularly beneficial at the distal section of the elongated member 104, such as at the section with the first incision pattern 120, to reduce the risk of accidental tissue damage. As an example, the rotational offset can be from about 102.5 degrees to about 145 degrees, or from about 105 degrees to about 140 degrees, or from about 107.5 degrees to about 135 degrees, or from about 110 degrees to about 130 degrees, or from about 115 degrees to about 125 degrees, or in the most preferred embodiment, about 120 degrees. The rotational offset can be within a range defined by any two of the above values at the endpoints.

[0107] Example benefits of the multi-pass cutting method

[0108] Figure 9A and Figure 9B respectively show a comparison of beams produced by the processes shown by Figures 5A to 5B and Figures 7A to 8C shown. Figure 9A is Figure 5C a diagram of beam 310 of Figure 9B is Figure 7E a diagram of beam 610 of Figures 8A to 8C and may also be similar to beam 710 of the process outlined in

[0109] Beam 310 has a pair of side surfaces 324, an inner arc length 320, and an outer arc length 322. As Figure 9A shown, the inner arc length 320 is shorter than the outer arc length 322. Beam 610 has a pair of side surfaces 624, an inner arc length 620, and an outer arc length 622. The inner arc length 620 and the outer arc length 622 are closer to each other in length, and the inner arc length 620 is even 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 about 1.2:1 (where the inner arc length 620 is slightly longer than the outer arc length 622) to 6:1 (where the inner arc length 620 is about six times the outer arc length 622). In some embodiments, the ratio of the inner arc length to the 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 has a ratio within a range defined by the endpoints of any two of the above values.

[0110] It has also surprisingly been found that three - and four - cut processes improve manufacturing efficiency and throughput compared to the standard single - cut - per - beam process. Even when the number of blades passed is doubled or tripled using the disclosed method, the multi - cut process requires less depth per cut and typically forms more precise incisions. Surprisingly, it has been found that this more than compensates for the additional time required for multiple cuts per beam.

[0111] In some embodiments, the cutting process is controlled by the length of each section of the micro - fabricated incision pattern (e.g., the lengths of the proximal, middle, and distal sections) and the degree of cutting distribution. For example, parameters related to length and degree can be stored in a software application to be executed by a computer system. Additionally and / or alternatively, the cutting process can be controlled by the desired ratio between the inner arc length and the outer arc length. Further, the cutting process can be controlled by the position of each section of the micro - fabricated incision pattern longitudinally disposed along the elongated member. For example, a micro - fabricated incision pattern located closer to the proximal end of the elongated member can include a single - cut - single - beam process, while a micro - fabricated incision pattern located closer to the distal end of the elongated member can include a three - cut - single - beam process.

[0112] Examples

[0113] Table 1 provides details regarding the outer arc length, inner arc length, and the ratio of inner arc length to outer arc length of the disclosed beam configurations. Specifically, Table 1 outlines the angular span and incision depth in forming each listed incision. Table 1 also outlines the inner arc length and outer arc length of each beam and their respective ratios. The minimum and maximum arc lengths are functions of the inner and outer diameters of the raw material used to form the final structure. In Table 1, the "3 - cut - 1 - beam" cutting type corresponds to the first incision pattern 120, the "2 - cut - 2 - beam" cutting type corresponds to the second incision pattern 122, and the "1 - cut - 2 - beam" cutting type corresponds to the third incision pattern 124 (see Figure 3 ). "Ratio" is the ratio of the average inner arc length to the average outer arc degree.

[0114] Cutting type Average ratio 3 cuts - 1 beam distal 2.80 3 cuts - 1 beam proximal 1.22 2 cuts - 2 beam distal 6.19 2 cuts - 2 beam proximal 2.30 1 cut - 2 beam distal 1.00 1 cut - 2 beam proximal 1.01

[0115] Table 1

[0116] Additional Terms and Definitions

[0117] Although certain embodiments of the present disclosure have been described in detail with reference to specific configurations, parameters, components, elements, etc., these descriptions are illustrative and should not be construed as limiting the scope of the claimed invention.

[0118] Furthermore, it should be understood that for any given element or component of the described embodiments, any possible alternatives listed for that element or component can generally be used alone or in combination with each other, unless otherwise implicitly or explicitly stated.

[0119] In addition, unless otherwise indicated, numbers expressing quantities, ingredients, distances, or other measurements used in the specification and claims are to be understood as optionally modified by the term "about" or its synonyms. When the terms "about", "approximately", "substantially", etc. are used in connection with a stated quantity, value, or condition, they may be considered to refer to a quantity, value, or condition that deviates from the stated quantity, value, or condition by less than 20%, less than 10%, less than 5%, or less than 1%. At a minimum, and without attempting to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits reported and by applying ordinary rounding techniques.

[0120] Any headings and subheadings used herein are for organizational purposes only and are not meant to limit the scope of the specification or claims.

[0121] 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 that refers to a single referent (e.g., "widget") can also include two or more such referents.

[0122] It should also be understood that the embodiments described herein can also include properties and / or features (e.g., ingredients, components, members, elements, parts, and / or portions) described in one or more separate embodiments and are not necessarily strictly limited to the features specifically described for that particular embodiment. Thus, the various features of a given embodiment can be combined with and / or incorporated into other embodiments of the present disclosure. Accordingly, the disclosure of certain features with respect to a particular embodiment of the present disclosure should not be construed as limiting the application or inclusion of such features to that particular embodiment. Rather, it should be understood that other embodiments can also include such features.

Claims

1. An intravascular device for a suction process, the device comprising: An elongate member including a proximal end, a distal end, and a lumen extending therebetween, the elongate member including a plurality of fenestrations that form a plurality of axially extending beams and a plurality of circumferentially extending rings, each beam including an inner surface, an outer surface, and two side surfaces, wherein the ratio of the inner arc length to the outer arc length of at least one beam is in the range of about 1.2:1 to about 6:

1.

2. The intravascular device according to claim 1, wherein, The intravascular device is a suction catheter.

3. The intravascular device according to claim 1, wherein, The elongate member includes a single-beam section where a single beam extends between each pair of adjacent rings.

4. The intravascular device according to claim 3, wherein, The single-beam section is the distal end of a double-beam section where two beams extend between each pair of adjacent rings.

5. The intravascular device according to claim 4, wherein, The double-beam section includes a double-beam section with double cuts per beam.

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

1.

7. The intravascular device according to claim 5, wherein, The double-beam section further includes a double-beam section with single cuts per beam.

8. The intravascular device according to claim 7, wherein, The ratio of the inner arc length to the outer arc length of each beam of the double-beam section with single cuts per beam is less than about 1.2, or less than about 1.1, or about 1 or less.

9. The intravascular device according to claim 5, wherein, The double-beam section with single cuts per beam is proximal to the double-beam section with double cuts per beam.

10. The intravascular device according to claim 3, wherein, The single-beam section includes a single-beam section with triple cuts per beam.

11. The intravascular device according to claim 10, wherein, The ratio of the inner arc length to the outer arc length of each beam of the single-beam section with triple cuts per beam is in the range of about 1.2:1 to about 6:

1.

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

13. The intravascular device according to claim 12, wherein, Each beam of the single-beam section is rotated about 100 degrees to about 150 degrees relative to adjacent beams, such as 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 about 120 degrees.

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

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

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

17. The intravascular device according to claim 16, wherein, The one or more polymer coatings include a variety of different polymers, each polymer having a different modulus and / or different hardness.

18. The intravascular device according to claim 17, wherein, The variety of different polymers are arranged along the elongate member to form a gradient flexibility profile.

19. The intravascular device according to claim 1, wherein, The elongate member includes nitinol.

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

21. A method of manufacturing an intravascular device for a suction process, the method comprising: Providing a piece of raw material; Inserting a blade into the raw material at a first longitudinal position to form a first cut in the raw material without completely penetrating the raw material, the blade being oriented such that the cutting edge is substantially perpendicular to the longitudinal axis of the raw material; Rotate the raw material relative to the blade without advancing the raw material longitudinally relative to the blade; Insert the blade into the raw material to form a second incision; Rotate the raw material relative to the blade a second time without advancing the raw material longitudinally relative to the blade; and Insert the blade into the raw material to form a third incision, wherein the method produces a single beam between adjacent rings at the first longitudinal position.

22. The method according to claim 21, wherein, For the first incision, the second incision, and the third incision, the blade is inserted into the raw material to the same depth.

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

24. A method of manufacturing an intravascular device for use in a suction process, the method comprising: Providing a piece of raw material; Inserting a blade into the raw material at a first longitudinal position to form a first incision in the raw material without completely penetrating the raw material, the blade being oriented such that the cutting edge is substantially perpendicular to the longitudinal axis of the raw material; Rotating the raw material relative to the blade without advancing the raw material longitudinally relative to the blade; Inserting the blade into the raw material to form a second incision; Rotating the raw material relative to the blade a second time without advancing the raw material longitudinally relative to the blade; Inserting the blade into the raw material to form a third incision; Rotating the raw material relative to the blade a third time without advancing the raw material longitudinally relative to the blade; and Inserting the blade into the raw material to form a fourth incision, wherein the method produces two beams between adjacent rings at the first longitudinal position.

25. The method according to claim 24, wherein, For the first incision, the second incision, the third incision, and the fourth incision, the blade is inserted into the raw material to the same depth.

26. The method according to claim 24, further comprising advancing the raw material longitudinally to one or more additional longitudinal positions and repeating the formation of incisions at each additional longitudinal position to form additional beams, 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 the method according to any one of claims 21 to 26.

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