Intravascular device

Abstract

An intravascular device for vascular navigation includes a tube having a selectively bendable portion. The selectively bendable portion may be mechanically actuated by an actuator control placed on the tube. The selectively bendable portion may be actuated to improve navigation of the intravascular device through a curved or twisted portion of a blood vessel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS AND INCORPORATION BY REFERENCE

[0002] The following applications are incorporated herein by reference in their entirety: U.S. Provisional Application No. 63 / 389,271, filed on July 14, 2022, and U.S. Provisional Application No. 63 / 409,562, filed on September 23, 2022. Background Art

[0003] The present disclosure relates to the field of intravascular medical devices. In particular, the present disclosure relates to intravascular devices intended to pass through a patient's blood vessels to reach a target area in the patient's body to perform a medical procedure.

[0004] An example of intravascular treatment relevant to the present disclosure is the use of intravascular devices such as catheters to treat stenosis, obstruction or bleeding of blood vessels (including neurovascular, cardiovascular and peripheral vasculature). For example, methods for treating acute stroke caused by vascular obstruction of the brain generally include intra-arterial administration of thrombolytic drugs such as recombinant tissue plasminogen activator (rtPA), mechanical removal of the obstruction, or a combination of the two. These interventional treatments must be performed within a few hours after the onset of symptoms. Both intra-arterial (IA) thrombolytic therapy and interventional thrombectomy involve access to the blocked cerebral artery via intravascular techniques and devices.

[0005] Devices used in these endovascular procedures can include balloons, snares, coils, stents, temporary stents (including temporary stents known as "stent retrievers"), suction (e.g., aspiration of blood clots with or without the assistance of disrupting the clot (e.g., by use of an aspiration catheter)), or a combination of these, depending on the condition to be treated and its anatomical location. Guide catheters, guide sheaths, or guidewires are typically used to introduce, guide, and / or position interventional devices within the peripheral, cardiovascular, and neurovascular vasculature from an arterial access site (typically the femoral or radial artery). These medical devices are typically used in a nested manner, i.e., a guidewire within a microcatheter within an intermediate catheter is advanced as an assembly to the target site.

[0006] It is worth noting that in order for the intravascular device to work effectively, the device needs to be positioned as close as possible to the source of interference, such as a blood clot or a site of vascular stenosis. This can be challenging in anatomical regions (such as the brain) where the blood vessels include tortuous anatomical structures. Existing guidewire devices typically require medical personnel to manually change the curvature of the tip of the device before inserting the device into the blood vessel, requiring medical personnel to replace the device with another more suitable guidewire during surgery, or to remove the guidewire, reshape it, and reintroduce it into the patient's body. In addition, due to the lack of support or rigidity (especially for the distal end of the catheter) and the lack of the ability to navigate through these rough blood vessels, these devices are generally difficult to overcome the problem of distal tortuous anatomical structures. Summary of the invention

[0007] In a first embodiment, an intravascular device includes: a tube, the tube including a selectively bendable portion, wherein at least a portion of the tube is configured to be inserted into a blood vessel; a plug, the plug disposed at a distal end of the tube, wherein the plug has a rounded tip configured to be inserted into the blood vessel; a gasket, the gasket disposed between the plug and the tube, the gasket being fixed relative to the tube; and a control element, the control element extending through at least a portion of the tube, the distal end of the control element being connected to the gasket, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend.

[0008] In a second embodiment, an intravascular device includes: a tube including a selectively bendable portion; a plurality of narrow slots formed in the tube, each of the plurality of narrow slots being disposed partially around the periphery of the tube; a control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend; and a gasket disposed within the tube and placed between the tube and the control element, the gasket being configured to reduce sliding friction between the tube and the control element.

[0009] A method for controlling the stiffness of an intravascular device according to an embodiment of the present disclosure begins by receiving a medical image captured during an intravascular procedure. The medical image is analyzed to detect a target region where a path of a vascular system to a target vessel changes direction. In addition, the medical image is evaluated to detect an intravascular device along the path. A specific portion of the intravascular device is then determined to be positioned at the target region, and the curvature of the specific portion of the intravascular device is controlled as needed.

[0010] A method for navigating a catheter through a blood vessel according to an embodiment of the present disclosure includes: guiding an intravascular device configured as a guidewire through the blood vessel to a location of interest, wherein the intravascular device includes a selectively bendable portion at a distal end of the intravascular device; and positioning the intravascular device at the location of interest, wherein the location of interest includes a location along the blood vessel. The method further includes: determining the direction of the distal end of the intravascular device by actuating the selectively bendable portion of the intravascular device to form a tip shape; and navigating the catheter through the blood vessel by advancing the catheter over the guidewire to the location of interest.

[0011] Certain aspects of the present disclosure have other steps or elements in addition to or in place of the steps or elements described above. The steps or elements will become apparent to those skilled in the art by reading the following detailed description when referring to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are included herein and form a part of this specification, illustrate the present disclosure and, together with the description, further serve to explain the principles of the present disclosure and enable those skilled in the relevant art to make and use the present disclosure.

[0013] Figure 1 is a perspective view of an intravascular device according to one embodiment.

[0014] Figure 1A is a perspective view of an intravascular device according to one embodiment.

[0015] Figure 2 is a perspective view of a distal portion of an intravascular device according to an embodiment.

[0016] Figure 3 yes Figure 2 Partial cross-sectional view of an intravascular device.

[0017] Figure 3A 1 and 2 are top and side views of an actuator of an intravascular device according to an embodiment.

[0018] Figure 3B is a partial cross-sectional view of an intravascular device according to one embodiment.

[0019] Figure 4 yes Figure 2 Cross-section of an intravascular device.

[0020] Figure 4A is a schematic cross-sectional view of an intravascular device according to one embodiment.

[0021] Figure 4B yes Figure 3B Cross-sectional view of an intravascular device.

[0022] Figure 4C 1 and 2 are top and side views of an actuator of an intravascular device according to an embodiment.

[0023] Figure 5 is a perspective view of a proximal portion of an intravascular device according to an embodiment.

[0024] Figure 6 yes Figure 5 Cross-section of an intravascular device.

[0025] Figure 7is a partial cross-sectional view of a proximal portion of an intravascular device according to an embodiment.

[0026] Fig. 7A is a detailed view of a portion of an intravascular device according to an embodiment.

[0027] Figure 8 is a perspective view of an intravascular device according to one embodiment.

[0028] Fig. 9 yes Figure 8 Partial cross-sectional view of an intravascular device.

[0029] Fig.10 is a cross-section of a proximal portion of an intravascular device according to an embodiment.

[0030] Fig.11 is a flow chart of a method of using an intravascular device according to one embodiment.

[0031] Fig.12 is a flow chart of a method of using an intravascular device according to one embodiment.

[0032] In the drawings, like reference numbers generally refer to the same or similar elements. In addition, the leftmost digit(s) of a reference number generally identifies the drawing in which the reference number first appears. DETAILED DESCRIPTION

[0033] Reference will now be made in detail to representative embodiments illustrated in the accompanying drawings. References to "one embodiment," "an embodiment," "an exemplary embodiment," etc. indicate that the described embodiment may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is considered to be within the knowledge of those skilled in the art to affect such feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described.

[0034] Intravascular devices used to perform intravascular medical treatments need to be able to navigate through a blood vessel to a treatment site. This can be difficult where the blood vessels involved include multiple turns because typical intravascular devices are unable to actively bend to navigate twists or turns. Therefore, an embodiment of the present disclosure is an intravascular device comprising a tube with a selectively bendable portion and a control element, wherein at least a portion of the tube is configured to be inserted into a blood vessel, and the control element is configured to control the curvature of the selectively bendable portion to enable navigation of the tube through the blood vessel.

[0035] The bendable nature of an intravascular device has several advantages, including improved ability to navigate tortuous vessels and the ability to selectively and controllably change the shape of a portion of an intravascular device from a proximal position, which may be beneficial during certain endovascular procedures. Some additional benefits are discussed below.

[0036] like Figure 1 It can be seen that the intravascular device 1 is formed as an approximately tubular device. The intravascular device 1 includes a distal end 2 and a proximal end 3 (also referred to as a "distal tip" and a "proximal tip" respectively). The proximal end 3 is the end of the tube 100, which is usually retained outside the patient's body and manipulated by the user (e.g., a doctor or other medical professional). The distal end 2 is the end of the tube 100 that is usually inserted into the patient's blood vessel. In some embodiments, the intravascular device 1 can have a total length of 1500 to 2500 millimeters (mm). In some embodiments, the intravascular device 1 can have a total length of about 2000 mm.

[0037] The intravascular device 1 is formed by a tube 100. The tube 100 constitutes the main body of the intravascular device 1. Figure 1 and 2 As can be seen, in some embodiments, tube 100 can be formed as a cylinder with a central opening. Tube 100 can be formed of any suitable material known in the art, such as metal or plastic, as discussed in detail below. Since tube 100 is used to be at least partially inserted into a blood vessel, the material of tube 100 should be biocompatible. Examples of materials for the tube 100 (e.g., for the entire body of the tube 100, or at least one of the distal end 2, the proximal end 3, or the intermediate tubular section including the non-bent portion 118 therebetween, and any combination thereof) are elastic and / or superelastic polymers, superelastic metals, or various metals / alloys / oxides, such as, but not limited to, elastomers, silicone polymer materials such as polydimethylsiloxane (PDMS), silicone adhesives, silicone rubber, natural rubber, thermoplastic elastomers, polyamides, polyimides, polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), acrylonitrile butadiene styrene (ABS), epoxy resins, polytetrafluoroethylene (PTFE), polyurethane, thermoplastic polyurethane (TPU), nylon, polyether block amide (PeBax), Kevlar, stainless titanium, steel or stainless steel, nickel titanium alloy (Nitinol), nickel chromium alloy, nickel chromium iron alloy, cobalt alloy, tungsten, cobalt, chromium, nickel, aluminum, copper, molybdenum, or any combination thereof. According to a specific embodiment, the tube 100 can be formed of stainless steel. According to some embodiments, tube 100 is configured as a unitary or single-piece element. In alternative embodiments, tube 100 is configured as a tube combining different materials (discussed in further detail below). In some embodiments, tube 100 is configured to be elastically deformable at least along some portion of its length, as described below.

[0038] In some embodiments, the outer diameter (OD) of the tube 100 may be from about 0.10 mm to about 1.10 mm. In some embodiments, the OD of the tube 100 may be from about 0.30 mm to about 0.90 mm. In specific embodiments, the OD of the tube 100 may be about 0.35 mm, about 0.45 mm, about 0.55 mm, about 0.65 mm, about 0.75 mm, or about 0.80 mm. As described above, the tube 100 may be formed as a cylinder with a central opening. According to some embodiments, the inner diameter (ID) of the tube 100 may be from about 0.10 mm to about 0.90 mm. In some embodiments, the ID of the tube 100 may be from about 0.20 mm to about 0.70 mm. In some specific embodiments, the inner diameter of the tube 100 may be about 0.20 mm, about 0.30 mm, about 0.40 mm, about 0.50 mm, or about 0.60 mm.

[0039] The intravascular device 1 includes at least one selectively bendable portion 110 (with Figure 1 ). Figure 1 As shown, the bendable portion can be located at the distal end 2, however, the bendable portion can be located at any other location along the tube 100 as needed and circumstantial. The bendable portion is controlled by an actuator control 200 at the proximal end 3, as discussed in detail below. As will be explained in detail below, some embodiments (such as Figure 1A The embodiment shown, etc.) can have multiple selectively bendable portions 110.

[0040] The selectively bendable portion 110 is a portion of the tube 100 that can be controllably bent relative to the original axis of the tube 100. As will be discussed further below, the selectively bendable portion 110 can be controlled by a user to improve the process of navigating an intravascular device through a patient's blood vessel. In some embodiments, the selectively bendable portion 110 can extend from about 5 mm to about 50 mm in an axial direction along the tube 100. In some embodiments, the selectively bendable portion 110 can extend from about 10 mm to about 30 mm in an axial direction along the tube 100. In some specific embodiments, the selectively bendable portion 110 can extend from about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, or about 25 mm in an axial direction along the tube 100.

[0041] Actuator control 200 is a control element that enables a user to control the selectively bendable portion 110. Actuator control 200 includes a handle 210 and a grip 212 for controlling the curvature of the selectively bendable portion 110.

[0042] The grip 212 is configured to allow a user to grasp the intravascular device 100. When the user moves the grip 212 linearly relative to the patient, the intravascular device 100 can be moved deeper or shallower in the patient's blood vessel. When the user moves the grip 212 torsionally, the tube 100 can be rotated within the patient's blood vessel, thereby effectively rotating the orientation of the selectively bendable portion 110.

[0043] The user can bend the selectively bendable portion 110, for example, by changing the relative distance between the handle 210 and the grip 212. For example, an interventional radiologist can grasp the handle 210 with one hand and grasp the grip 212 with the other hand. By increasing the relative distance, the selectively bendable portion 110 becomes more curved, for example, the radius of curvature becomes shorter. And, by decreasing the relative distance, the degree of curvature of the selectively bendable portion 110 becomes less, for example, the radius of curvature becomes longer, until the selectively bendable portion 110 becomes a straight extension of the tube 100. In this way, a user, such as an interventional radiologist, is able to adjust the selectively bendable portion 110 according to the conditions that will arise in the patient's vascular access. Figure 5-8 Describe how to achieve this curvature control.

[0044] For example, when an artery or vein branches in two directions, the user can move the handle 210 relative to the grip 212 to produce a desired curvature. The user can then rotate the grip 212 to bend the selectively bendable portion 110 toward the desired branch, and can linearly move the grip 212 to move the distal end 2 of the intravascular device 1 down the desired branch. In this way, the user can navigate the distal end 2 of the intravascular device 1 to a desired location within the patient's vascular system.

[0045] In some embodiments, Figure 2-3 It can be seen that a plurality of openings 102 are formed in the tube 100. As described above, the tube 100 can be made of any suitable material, including medical grade stainless steel. The openings 102 are portions removed from the material (e.g., cuts). In some embodiments, these openings 102 are formed as narrow grooves in the tube 100 that penetrate from the outside of the tube 100 to the inside of the tube 100 at least partially around the periphery of the tube 100. In some embodiments, the plurality of openings 102 penetrate from the outside of the tube 100 to the inside of the tube 100. In these embodiments, when the intravascular device 1 is inserted into a patient's blood vessel, fluid can pass through the openings 102. As shown in FIG. Figure 2 As shown, the opening 102 does not extend around the entire circumference of the tube 100. The opening 102 may extend from ten to ninety percent of the circumference of the tube 100, for example.

[0046] In some embodiments, the projection of the opening 102 on the surface of the tube 100 may be a regular rectangular shape (eg, Figure 21 and 2). In these embodiments, for example, the width of the opening 102 in the axial direction can be about 0.01 mm to about 0.1 mm. According to some specific embodiments, the width of the opening 102 in the axial direction can be about 0.02 mm to about 0.06 mm. The projection of the opening 102 on the surface of the tube 100 can also be different shapes, such as slits, circles, ellipses, triangles, or any other desired polygonal shapes. For example, a plurality of openings 102 can be etched from the tube 100 using any manufacturing method known in the art, such as by cutting or grinding, for example with a disk, with a semiconductor cutting blade, or using a laser.

[0047] By removing material from the tube 100, the plurality of openings 102 reduces the stiffness or resistance to bending of the tube 100. Thus, the openings 102 can be used to create more flexible or bendable portions of the tube 100. These are portions of the tube 100 that are more susceptible to controlled bending, as will be discussed below. Thus, varying the extent of the openings 102 can be used to control the flexibility of the tube 100. For example, increasing the extent by increasing the size, number, shape, or density of the openings 102 will reduce the stiffness of the tube 100, or increase the tendency to bend. Conversely, decreasing the extent by decreasing the size, number, shape, or density of the openings 102 will increase the stiffness of the tube 100, or reduce the tendency to bend. Thus, as Figure 1 As shown, the selectively bendable portion 110 of the tube 100 has a plurality of openings 102, while the second portion of the tube 100 is free of openings 102. Additionally, the tube 100 may include a third portion (e.g., a non-bend portion 118, discussed further below) that includes a plurality of openings 102, but with a reduced size, number, or density of openings 102 as compared to the selectively bendable portion 110. The third portion of the tube 100 may be positioned anywhere along the tube, such as between the selectively bendable portion 110 and the second portion of the tube 100, and provide a degree of softness to the tube at any desired location depending on the needs and circumstances of the device.

[0048] It should be noted that the tube 100 can be bent to a certain extent without any openings 102. However, the addition of openings 102 allows for the creation of a targeted selectively bendable portion 110. In some embodiments, as shown in FIG. Figure 2As shown, the plurality of openings 102 have the same size, but have different spacings therebetween. For example, the spacing of the plurality of openings 102 disposed in the selectively bendable portion 110 may be about 0.03 mm to about 0.2 mm (e.g., a pitch of about 0.06 mm to about 0.3 mm). According to a specific embodiment, the spacing of the plurality of openings 102 disposed in the selectively bendable portion 110 may be about 0.08 mm to about 0.06 mm (e.g., a pitch of about 0.12 mm to about 0.16 mm). The plurality of openings 102 in a separate, more proximal portion of the tube 100 (such as in the third portion discussed above) are smaller and may be spaced farther apart, and may be spaced about 0.03 mm to about 3 mm (e.g., a pitch of about 0.06 mm to about 3 mm).

[0049] In another example, changing the range of the openings 102 is to change the spacing between the plurality of openings 102. A larger spacing between the plurality of openings 102 will increase the stiffness of the tube 100, while a smaller spacing between the plurality of openings 102 will reduce the stiffness of the tube 100. This technique can be used to generate a variable stiffness gradient to adjust the stiffness of the tube 100 as needed. For example, in some embodiments, the spacing or pitch of the plurality of openings 102 in the selectively bendable portion 110 is smaller at the end closest to the distal end 2 of the selectively bendable portion 110. In these embodiments, the spacing increases toward the end closer to the proximal end 3 of the selectively bendable portion 110. In this way, the selectively bendable portion 110 is biased to be more flexible closer to the distal end 2, which is the end first inserted into the blood vessel. The rate of change of the spacing may be constant, or may be variable, to adjust the stiffness change as needed. In some embodiments, there are no openings 102 at a predetermined distance from the proximal end 3 of the tube 100. This may desirably increase the stiffness of the proximal portion of the tube 100. This portion of the tube 100 may also be the portion of the tube 100 that is used to remain outside the patient's body during an endovascular procedure.

[0050] In some embodiments, the design or material of tube 100 can also be used to adjust the flexibility of tube 100. For example, the cross-sectional size or shape of tube 100 can be changed to increase or decrease flexibility. Changing the material of tube 100 can also change flexibility. For example, Figure 4A As shown, two or more parts of the tube 100 can be made of different materials, which can be used to change flexibility. For example, a harder material will make the corresponding part of the tube 100 less flexible. This may be useful when it is desired to change the flexibility without changing the outer dimensions of the tube 100. These different materials can be connected together by a connector 103. The connector 103 can be, for example, any suitable connection technology, including but not limited to adhesives, welding or using mechanical connectors such as rings or sleeves (used alone or in combination with other connection technologies).

[0051] like Figure 1-3 As can be seen, in some embodiments, a single selectively bendable portion 110 is disposed at the distal end 2 of the tube 100. This makes the portion of the tube 100 at the distal end 2 more flexible and, therefore, selectively bendable. The selectively bendable portion 110 may also be disposed at various other points along the tube 100 as desired to increase flexibility and control. Thus, the selectively bendable portion 110 may be disposed at a distal portion of the intravascular device 1 other than the distal end 2, such as up to about 150 mm from the distal end 2. Figure 2-3 It can be seen that in some embodiments, this selectively bendable portion 110 located distally terminates at a plug 112 at the distal end 2. The plug 112 is used to end or seal the distal end 2. The plug 112 is generally a non-destructive and non-sharp tip, which generally has a rounded, oval or similar shape to improve the ability of the tube 100 to pass through the blood vessel in an atraumatic manner. The gasket 114 is placed between the selectively bendable portion 110 and the plug 112. The plug 112 and the gasket 114 can be fixedly connected to the tube 100 by any suitable method, including but not limited to welding, soldering, brazing, adhesives or mechanical connections such as fasteners or crimping. The plug 112 and the gasket 114 can be made of any suitable biocompatible material, including metals, metal alloys / oxides, adhesives, silicones and plastics or any combination thereof. X-ray opaque materials, such as platinum, gold, tungsten, tantalum, etc., can be incorporated into the plug or gasket to act as a fluorescent marker to help visualize when navigating the device in the blood vessel.

[0052] In some embodiments, the selectively bendable portion 110 is the only portion of the tube 100 that can be controllably actuated or bent. Therefore, there can be one or more non-bend portions 118 disposed throughout the tube 100. These non-bend portions 118 can be disposed immediately adjacent to the selectively bendable portion 110, or can be spaced apart from the selectively bendable portion 110. It should be noted that the non-bend portions 118 can and typically still have some ability to passively flex and bend, depending on the stiffness of the tube 100 at the non-bend portions 118. Techniques for adjusting this stiffness are discussed below.

[0053] like Figure 3-4As can be seen, for example, the intravascular device 1 may include a control element 120 (also referred to as an actuator) disposed within the tube 100. The control element 120 may be in the form of any appropriately rigid element that can slide freely within the tube 100. Sufficient rigidity is required to prevent the control element 120 from over-bending when compressed (during the straightening of the selectively bendable portion 110). However, the control element 120 must also be sufficiently flexible so that the control element 120 does not make the tube 100 too stiff. The rigidity of the control element 120 also affects the flexibility of the selectively bendable portion 110, and therefore the portion of the control element 120 that passes through the selectively bendable portion 110 must be designed to allow the selectively bendable portion 110 to bend as desired. The control element 120 may be made of any suitable biocompatible material, including metals, metal alloys, and plastics or any combination thereof. According to one embodiment, the control element 120 may be a solid wire, a multi-filament wire, a rope, or a thin wire. For example, the control element 120 may be a solid metal wire formed of any material known in the art, such as, but not limited to, Nitinol alloy, stainless steel, and plastic material, or any combination thereof. Figure 1-4 As shown, the control element 120 may be formed as a solid wire sized to fit within the tube 100. The control element 120 may also take the form of a tube, as will be discussed below.

[0054] The function of the control element 120 is to transmit a force to selectively bend or straighten the selectively bendable portion 110. This is accomplished by securing the distal end of the control element 120 to the distal end of the selectively bendable portion 110 (or to a different attachment point of the selectively bendable portion 110, depending on the needs and circumstances of the device). According to one embodiment, the distal end of the control element 120 is secured to a washer 114, which in turn is secured to the end of the selectively bendable portion 110. Because the selectively bendable portion 110 can be placed anywhere along the tube 100, the washer 114 can be positioned at different locations along the tube 100, depending on where the selectively bendable portion 110 begins and ends. As shown in FIG. Figure 3 , 3B As can be seen from Figures 4A and 4A, in one embodiment, the control element 120 passes through the opening in the gasket 114 and is bent to fit into the groove 115 in the gasket 114. For example, as shown in FIG. Figure 3 and 3B As can be seen, the control element 120 extends through the washer 114 extending in the axial direction and then bends back approximately 180 degrees to fit into the groove 115, forming a U-shaped curve. In this way, the control element 120 is axially and rotationally fixed to the washer 114 at the distal end 2 of the intravascular device 1. Examples of these types of curves are shown in Figure 3 , 3BIn addition to passing through the gasket 114 as described, the control element 120 can also be secured by adhesive and mechanical means such as friction fit or forming additional bends / angles in the control element 120. This manner of connecting the control element 120 to the gasket 114 also improves the connection between the tube 100 and the control element 120 because the gasket 114 significantly reduces the possibility of the control element 120 being separated from its fixed position relative to the tube 100.

[0055] The control element 120 may otherwise slide freely within the tube 100 to transfer force from the actuator control 200 to the washer 114 at the distal end 2. Figure 2 In the straightened position shown, retraction of the control element 120 relative to the tube 100 toward the proximal end 3 will cause the selectively bendable portion 110 to bend to accommodate the shortened length of the control element 120 (eg, Figure 1 ). Conversely, extension of the control element 120 toward the distal end 2 will cause the selectively bendable portion 110 to straighten. More specifically, in one embodiment, movement of the handle 210 in the proximal direction may increase the tension on the control element 120, resulting in a curvature of the selectively bendable portion 110, while movement of the handle 210 in the distal direction may reduce the tension on the control element 120, causing the selectively bendable portion 110 to straighten.

[0056] In some embodiments, control element 120 can be configured to increase the propensity of selectively bendable portion 110 to bend in a desired direction or directions. This is accomplished by changing the shape of control element 120 to increase its propensity to bend in a given direction or directions. Thus, control element 120 can have any transverse cross-section (perpendicular to the longitudinal axis), such as circular, oval, square, rectangular, etc.

[0057] For example, in a situation similar to Figure 4 In the embodiment of the present invention, the control element 120 is formed of a solid metal wire with a varying cross-section. In this embodiment, the control element 120 has a circular cross-section closer to the proximal end 3. As the control element 120 continues in the distal direction, the control element 120 flattens and has a rectangular cross-section, such as Figure 4 The rectangular cross-section tends to bend in a direction perpendicular to the long sides of the rectangle, thereby creating a preferred or biased bending direction for the selectively bendable portion 110 in which the control element 120 is disposed.

[0058] Additionally or alternatively, the control element 120 can maintain the same cross-section, but change size to change the bending tendency. For example, the control element 120 can maintain a circular cross-section, but the diameter can be increased or decreased to increase or decrease stiffness, respectively. This type of control element 120 will not have a biased bending direction because the cross-sectional shape is maintained, but depending on the size of the control element 120, the control element 120 will have a lesser or greater bending tendency. When combined with the characteristics of the tube 100, the size of these changed areas of the control element 120 can be varied to achieve the desired bending resistance. For example, in one embodiment, this type of control element 120 can have different first, second, and third diameters at different locations along the length of the control element 120.

[0059] For example, one embodiment of the control element 120 is shown in Figure 3A , which shows a side view and a top view of a control element 120. In this embodiment, the control element 120 has a constant diameter portion 120a, a tapered portion 120b, and a flat portion 120c. The constant diameter portion 120a has a cross section of a predetermined diameter, which can correspond to the portion of the control element 120 that is closer to the proximal end 3 of the tube 100 when assembled into the intravascular device 1. The diameter of the tapered portion 120b continues to decrease as the distance from the constant diameter portion 120a increases. The flat portion 120c has a rectangular cross section (thus, it is flat when compared to other portions of the control element 120), and when viewed from the top, the width of the rectangular cross section of the flat portion 120c increases as the distance from the tapered portion 120b increases. The flat portion 120c can correspond to the selectively bendable portion 110, and therefore can correspond to the distal end 2 of the tube 100. Those skilled in the art will appreciate that as the distance from the constant diameter portion 120a increases, the flexibility of the control element 120 in all bending directions in the tapered portion 120b will increase due to the reduced diameter. Due to the flat cross-sectional shape, the bending of the flat portion 120c is biased with respect to the bending in the direction inward and outward of the figure when viewed from above. This embodiment of the control element 120 is shown in FIG. Figure 3B of the tube 100, and Figure 3B A cross section is shown in Figure 4B middle.

[0060] In some embodiments, the diameter of the constant diameter portion 120a ranges from about 0.1 to about 0.45, for example, about 0.140 to about 0.180 mm. At the proximal end of the tapered portion 120b, the tapered portion has the same diameter as the constant diameter portion 120a. The tapered portion 120b can taper to a diameter of about 0.065 mm to about 0.2 mm. The taper can be evenly distributed along the axial length of the tapered portion 120b (linear taper), or can be unevenly distributed. The flat portion 120c can have a width dimension starting from the minimum diameter of the tapered portion 120b and increasing to the diameter of the constant diameter portion 120a. As shown in FIG. Figure 3A As can be seen, there may be four steps of increasing width, with the first (most proximal) step ranging from about 0.100 mm to about 0.170 mm, the second step ranging from about 0.110 mm to about 0.180 mm, the third step ranging from about 0.120 mm to about 0.190 mm, and the fourth step ranging from about 0.130 mm to about 0.200 mm. Here, the width dimension is defined as Figure 3A The dimensions of the lower portion in the top to bottom direction of the top view. It should be understood that there may be more or fewer steps in the flat portion 120c to adjust the flexibility as needed or desired. The flat portion 120c may also flatten and expand in width in a gradual, non-stepped manner, such as Figure 4C shown.

[0061] The biased bend as discussed above can also be achieved by unevenly distributing the open area caused by the openings 102 around the periphery of the tube 100. For example, making the opening 102 on one side of the tube 100 larger will cause the tube 100 to bend in the direction of that side. Using any combination of these methods to bias the bend of the tube 100 has the advantage of providing a predictable bend for the user of the intravascular device 1. This is particularly helpful when the distal end 2 of the tube 100 has been inserted into a blood vessel and is not visible. The orientation of the rest of the tube 100 (which exists outside the blood vessel) allows the user to understand the direction in which the distal end of the tube 100 with such a bias will bend relative to the blood vessel.

[0062] In some embodiments, there may be two or more selectively bendable portions of the tube 100. These selectively bendable portions of the tube 100 may include offset bend regions that are achieved by having an asymmetrical distribution of openings 102, as discussed above.

[0063] The same tube 100 having asymmetrically distributed openings 102 at one or more selectively bendable portions of the tube 100 may also have a set of symmetrical openings in a different portion of the tube 100. These symmetrical openings 102 increase the flexibility of the tube 100 without introducing any directional bias. Finally, the same tube 100 may have a portion without any openings 102, for example, on the portion of the tube 100 that is intended to remain outside the patient's body during the procedure.

[0064] For example, in some embodiments, as discussed above, there may be a selectively bendable portion 110 with asymmetric openings disposed at the distal end 2. Moving proximally from the selectively bendable portion 110, there is a non-bend portion 118 having openings 102 disposed symmetrically around the periphery of the tube 100 to increase the flexibility of the tube 100. In this embodiment, as the non-bend portion 118 extends axially toward the proximal end 3, the openings 102 in the non-bend portion 118 have increasing spacing or pitch in the axial direction. This has the effect of gradually increasing the stiffness of the tube 100 in the proximal direction. Finally, the portion of the tube 100 proximal to the non-bend portion 118 is free of openings 102. These features provide the intravascular device with a soft, flexible, and controllable distal section that is optimal for navigating in tortuous anatomical structures while providing support, shape retention, and maintaining optimal torque transmission and customized pushability in the more proximal portion.

[0065] The movement of the control element 120 within the tube 100 may cause friction. To reduce the friction generated between the control element 120 and the tube 100, the intravascular device 100 may include a spacer 130.

[0066] like Figure 3 and 4 As can be seen, the gasket 130 can be placed between the control element 120 and the interior of the tube 100. The gasket 130 acts as a spacer and guide to limit the movement of the control element 120 within the tube 100. In these embodiments, and as discussed in the following paragraphs, the gasket 130 is described as a solid material. However, the gasket 130 can also include a liquid lubricating element, or can be liquid lubricated only. For example, oil can be added to the interior of the tube 100 (e.g., near the distal end 2). This oil can reduce the friction between the control element 120 and the tube 100. Examples of suitable oils can include, but are not limited to, silicone oil.

[0067] The gasket 130 is fixed to the interior of the tube 100. Suitable methods for fixing the gasket 130 to the tube 100 include, but are not limited to, welding, soldering, brazing, using adhesives, and mechanical connections. In some embodiments, the connector 132 fixes the gasket 130 to the tube 100. In other embodiments, the gasket 130 can be fixed to the gasket 114 using any method known in the art, such as using an adhesive, which in turn means that the gasket 130 is fixed to the tube 100 because the gasket 114 is fixed to the tube 100. According to one embodiment, the gasket 130 can completely surround the control element 120 circumferentially. Alternatively, the gasket 130 can only partially surround the control element 120 circumferentially. In some embodiments, the gasket 130 extends along the entire length of the tube 100. In other embodiments, the gasket 130 only extends along a portion of the axial length of the tube 100. In other embodiments, the gasket 130 extends along a portion of the selectively bendable portion of the tube 100.

[0068] In some embodiments, the gasket 130 can be formed as a continuous tube of material. In other embodiments, the gasket 130 can be formed by a band or wire wound in a spiral or coil within the tube 100. In other embodiments, the gasket 130 can be formed by several bands or wires of material wound in a spiral or coil within the tube 100. Other possible forms of the gasket 130 include a separate strip of material extending along the length of the tube 100, or discrete rings of material separated from each other. The gasket 130 can be formed of a biocompatible material that allows the control element 120 to slide relative to the gasket 130. For example, but not limited to, the gasket 130 can be made of metal, metal alloy / oxide, silicone and plastic material or any combination thereof. Exemplary materials of the gasket 130 include nitinol, platinum, iridium, polytetrafluoroethylene (PTFE), fluoropolymers such as polytetrafluoroethylene.

[0069] In some embodiments, the material selected for the gasket 130 is radiopaque, meaning that when the gasket 130 is placed in the body, the gasket is visible in an X-ray scan or similar type of medical imaging. This can be achieved through material selection or by adding additives or coatings to the gasket 130. For example, materials such as gold, platinum, tungsten, tantalum, etc. can be incorporated into the gasket 130 to act as fluorescent markers to aid visualization. According to one embodiment, the gasket 130 is at least partially formed of a material selected from the group consisting of a metal alloy and a fluoropolymer material to ensure that the gasket 130 is substantially radiopaque. In other embodiments, the tube 100 can be radiopaque through material selection (as discussed above) or by adding additives or coatings (discussed below).

[0070] like Figure 5-7As can be seen, actuator control 200 is disposed at proximal end 3 of tube 100. As described above, actuator control 200 allows a user to move control element 120 relative to tube 100. This portion of tube 100 and actuator control 200 is typically located outside of the patient's vessel and body.

[0071] In an embodiment, the actuator control 200 is formed by a tubular handle 210 disposed around the proximal end 3 of the tube 100. The handle 210 is configured to slide around the exterior of the tube 100. This enables the handle 210 to move relative to the grip 212, as described above. The handle 210 extends distally along the tube 100 to the distal end of the tube 100. According to an embodiment, the handle 210 can extend beyond the proximal end 3 of the tube 100.

[0072] The control element 120 passes from the proximal end 3 of the tube 100 and into the center of the handle 210 and is fixedly connected to the interior of the handle 210 by any suitable means, including but not limited to welding, soldering, brazing, adhesives, or mechanical connections such as fasteners or crimping. Therefore, in some embodiments, the control element 120 runs through the entire length of the tube and is connected to the proximal end 3 of the tube 100. For example, Figure 6 As can be seen, the control element 120 can extend to and be secured to the plug 218 that closes the end of the handle 210. In this manner, movement of the handle 210 relative to the tube 100 causes the control element 120 to move, and in turn, cause the selectively bendable portion 110 to bend.

[0073] As described above, the grip 212 is placed around the exterior of the tube 100, distal to the handle 210. The grip 212 is fixed to the exterior of the tube 100 and is configured to act as a rest for the user's hand to better control the movement of the handle 210. Both the grip 212 and the handle 210 can have a comfortable, non-slip gripping surface suitable for grasping by hand. The handle 210 can be formed of a composite construction, wherein the portion of the handle 210 adjacent to the tube 100 is formed of a material such as a hard plastic suitable for sliding against the tube 100, while the portion of the handle 210 facing the outside can be formed of a rubber or foam material to improve the user's grip.

[0074] A stop 216 may be included as part of the actuator control 200. The stop 216 is used to prevent the handle 210 from being advanced too far distally along the tube 100. Figure 6As can be seen, in some embodiments, the stop 216 is a protrusion fixed to the tube 100. This protrusion extends a predetermined distance inside the handle 210. Suitable methods for fixing the stop 216 to the tube 100 include, but are not limited to, welding, soldering, brazing, using adhesives, and mechanical connections. The friction element 140 contacts the stop 216, and because the friction element 140 is fixed to the control element 120, which is in turn fixed to the handle 210 (via the plug 218), the friction element 140 prevents the handle 210 from advancing too far. Other embodiments of the stop 216 may include structures such as a protrusion or ring fixed to the interior of the handle 210, which are configured to perform the same function.

[0075] like Figure 5 As can be seen, one or more markings 214 can be placed on the exterior of tube 100 so that a user can determine the degree of bending by aligning handle 210 with markings 214. Markings 214 can include a neutral marking corresponding to the straightened position of selectively bendable portion 110.

[0076] A key structure 150 may be formed in the tube 100 to ensure that the rotational torque of the control element 120 is transmitted to the tube 100. For example, the user may twist the handle 210 relative to the axis of the tube 100, which in turn applies a rotational torque to the control element 120. The key structure 150 ensures that this torque is transmitted to the tube 100, thereby achieving the effect of rotating the tube 100 according to the torque applied by the user. For example, Fig. 7A An embodiment of a key structure 150 is shown, the key structure comprising a material placed inside the tube 100 and fixed to the tube 100. The opening in the key structure 150 can be shaped to correspond to the shape of the narrow portion 151 of the control element 120. The shape of the narrow portion 151 (and the corresponding key structure 150) is selected to prevent the control element 120 from rotating relative to the tube 100. For example, the control element 120 can be flattened into a rectangular cross-section at the narrow portion 151. It should be understood that any suitable shape can be used to prevent the control element 120 from rotating. The material of the key structure 150 can be any suitable material known in the art, including but not limited to metals, plastics (such as polyetheretherketone (PEEK)), and composite materials. The key structure 150 can be fixed to the tube 100 using any suitable process, including but not limited to adhesives, welding, soldering, and brazing.

[0077] like Figure 6As can be seen, the friction element 140 can be placed inside the tube 100. The role of the friction element 140 is to increase the sliding friction acting on the control element 120. This has at least two benefits. First, it allows the operating feel of moving the control element 120 to be adjusted to a desired value. This is important because too low a level of friction will cause the control element 120 to move unexpectedly. Too high a level of friction may make the control element 120 difficult to use accurately. In some embodiments, the desired level of friction is about 0.5 to 2.0 Newtons, which is measured as the force required to overcome the sliding friction and move the handle 210. The second advantage of adjusting the sliding friction is that it enables the control element 120 to be designed to remain in a given position after being set. This is important because, for example, the unwanted movement of the control element 120 caused by the movement of the intravascular device 1 within the blood vessel may cause problems such as the intravascular device 1 moving from a given position, such as when a catheter (e.g., a suction catheter) moves along a guidewire to reach the position of interest.

[0078] like Figure 6 It can be seen that in some embodiments, the friction element 140 is formed by a tubular sleeve 142 that is arranged around the control element 120 within the tube 100. The tubular sleeve 142 is fixed to the control element 120, for example, by adhesive, welding, friction fit, or press fit. The tubular sleeve 142 has sufficient rigidity to be formed into different shapes. Figure 6 It can be seen that according to one embodiment, the tubular sleeve 142 can form several turns so that there are several different contact points 144 between the tubular sleeve 142 and the interior of the gasket 130 (or, in some embodiments, the interior of the tube 100). These contact points 144 generate friction when the control element 120 moves.

[0079] The friction generated can be adjusted by changing the total number of contact points 144, the contact surface area at each contact point 144, and the applied pressure applied between the contact point 144 and the interior of the gasket 130. For example, adding additional bends to the tubular sleeve 142 creates more contact points 144, thereby increasing friction. Increasing the angle of each bend increases the surface area of ​​the contact point 144, also increasing friction.

[0080] The friction element 140 may be placed anywhere in the tube 100, however, it may be desirable to place the friction element 140 in the portion of the tube 100 that is intended to remain outside the body (near the proximal end 3). This ensures that the rigidity of the friction element 140 does not affect how the tube 100 bends inside the body.

[0081] like Figure 7 It can be seen that in other embodiments, the friction element 140 can adjust the friction between the handle 210 and the exterior of the tube 100. Figure 7In the embodiment of the present invention, a pair of tubes from the friction element 140 are fixed inside the handle 210. These tubes slide along the outside of the tube 100 to set the friction force to the desired level. Other embodiments of the friction element 140 may include structures such as separate rings or washers that are fixed to the control element 120 and contact the inner surface of the shim 130. Adjustment of the friction force can be achieved in the same manner as discussed above by increasing the number or size of contact points between the rings / washers and the shim 130. Other embodiments of the friction element 140 may include structures such as rings, sleeves, or tubes that are fixed to the inside of the shim 130 through which the control element 120 passes. In some embodiments, these structures can be integrated into the shim 130, for example as a narrow section of the shim 130 that applies friction to the control element 120.

[0082] like Figure 1A and 8 As shown in FIG. 10 , in some embodiments, the tube 100 includes a plurality of selectively bendable portions 110. For example, there may be one, two, three, four, or more selectively bendable portions 110. Adding more selectively bendable portions 110 may improve the ability of the intravascular device 1 to navigate a blood vessel because it adds more controllable directionality to the tube 100. In some embodiments, as shown in FIG. Figure 8 As shown, one selectively bendable portion 110 is disposed at the distal end 2, as discussed above. The second selectively bendable portion 110 is disposed closer to the proximal end 3 of the tube 100. In some embodiments, the two selectively bendable portions 110 are adjacent to each other. In other embodiments, the two selectively bendable portions 110 are separated by a non-bent portion 118 of the tube 100. In some embodiments, the spacing in the axial direction is about 5 mm to about 100 mm. According to some embodiments, the spacing in the axial direction is about 10 mm to about 50 mm. According to a specific embodiment, the spacing in the axial direction is about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, or about 30 mm. The above discussion on biasing the tube 100 is also applicable to multiple selectively bendable portions 110. For example, using the technology discussed above, each selectively bendable portion 110 can be biased in a radial direction, which may or may not be the same direction as any other selectively bendable portion 110.

[0083] Each selectively bendable portion 110 includes its own control element 120 that extends through the tube 100 and is fixed to the distal end of the selectively bendable portion 110. In addition, each of the plurality of selectively bendable portions 110 may have a spacer 130, a friction element 140, and an actuator control 200 disposed at the proximal end 3, such as Fig.10This enables completely independent control of each selectively bendable portion 110. In some embodiments, a single handle 212 is shared between multiple independent actuator controls 200. In other embodiments, there are two handles 212, each of which works in conjunction with one of the two actuator controls 200.

[0084] exist Figure 1A and Figure 8-10 In the exemplary embodiment shown, the control element 120 corresponding to the distal selectively bendable portion 110 is a wire (e.g., a solid wire having a varying cross-section as discussed in detail above). The wire control element 120 is secured to the more distal selectively bendable portion 110 using the techniques discussed above. In addition, a spacer 130 may be placed between the wire control element 120 and the tube 100, such spacer also being secured to the tube 100 using the techniques discussed above. The control element 120 corresponding to the more proximal selectively bendable portion 110 is a tube (also referred to as a "second tube") that is disposed between the wire control element 120 and the tube 100. A proximal spacer 130 may also be used between the tube control element 120 and the tube 100. This configuration allows for a symmetrical distribution of the plurality of actuators 120, which reduces the effect on the bending of the tube 100. The tube control element 120 is secured to the more proximal selectively bendable portion 110 using the techniques discussed above. Additionally, the proximal spacer 130 is secured to the more proximal selectively bendable portion 110 using the techniques discussed above. However, the washer 114 associated with the more proximal selectively bendable portion 110 need not necessarily be present.

[0085] In some embodiments, each control element 120 is formed as a wire, each control element 120 is guided through the center of the tube 100, and then secured to its corresponding selectively bendable portion 110 using the techniques discussed above. As discussed above, in some embodiments, it is desirable to secure the control element 120 to the most distal end of the selectively bendable portion 110, although different attachment points may also be employed. In these embodiments, each control element 120 may have its own spacer 130, or a single spacer 130 may be used as discussed above.

[0086] A plurality of actuator controls 200 for use in a device that includes two or more selectively bendable portions 110 that function the same as the single selectively bendable portion 110 discussed above. Fig.10As can be seen, the multiple handles 210 for each actuator control 200 are staggered along the tube 100 so that the multiple handles 210 can be independently actuated. For example, the handle 210 associated with the proximal selectively bendable portion 110 can be placed further distally along the tube 100. The connection between this handle 210 and its control element 120 can be achieved through a slot or opening in the tube 100. The handles 210 associated with the proximal selectively bendable portion 110 can be arranged as discussed above. The two handles 210 can have a plurality of markings 214 configured in a manner as discussed above, and each of the two handles 210 can also have a stop 216 that serves as a travel stop as discussed above.

[0087] In some embodiments, at least some parts of the tube 100 can be coated with various substances to improve system performance. For example, according to needs and circumstances, the outer surface of the tube 100 for insertion into the patient can be equipped with elastic or other compliance, biocompatible coating or sheath in whole or in part to provide a smooth outer surface (hydrophobic or hydrophilic). The coating material is selected to minimize its sliding friction during the device is inserted into and removed from the subject's body, and the coating material is substantially chemically inert in the in vivo vascular environment. According to one embodiment, the outer surface of the tube 100 can have a hydrophilic coating to reduce the friction between the tube 100 and the blood vessel. Examples of suitable coatings include, but are not limited to, polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), urethane, polyurethane, thermoplastic polyurethane (TPU), silicone polyether block amide (PeBax), nylon or polyethylene (PE), other polymers, polyurethane polymers, and elastomers are also suitable for coatings. In addition or alternatively, the coating material can be selected according to its hydrophilic properties to improve its sliding and navigation in the blood. Typically, such a coating is applied at the distal end 2 of the tube 100 and extends up to 50 cm from the tip. Suitable coatings may be formed by any method known in the art, such as by dipping, spraying or winding and heat curing operations.

[0088] Other coating options include drugs that can be delivered to the patient during the operation of the intravascular device 1. Such drugs can be used to treat patients, assist the efficacy of the surgery or avoid complications that may occur in the surgery. For example, this type of coating can include anti-restenotic drugs (including drugs that inhibit coagulation, such as anticoagulants, antithrombotics and antiplatelet agents, such as clopidogrel and heparin), anti-inflammatory agents, immunosuppressants, antibiotics, hypolipidemic agents, antiproliferative agents and pro-endothelial agents. Examples of detailed lists of these types of coatings can be found in Rykowska I. et al., "Molecules" (2020) 25: 4624; Tables 8 and 12 in doi: 10.3390 / molecules25204624, which are incorporated herein by reference.

[0089] In some embodiments, the control element 120 can be coated to reduce friction. Suitable coatings for the control element 120 include polymers and elastomers. For example, polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), nylon can be used to coat the control element 120 to reduce friction when the control element 120 moves relative to the tube 100. Suitable coatings can be formed by any method known in the art, as discussed above.

[0090] like Fig.11 As illustrated, the method of navigating a catheter begins at step 1102, when the distal end 2 of the intravascular device 1 is inserted into a blood vessel by a user (such as a physician or other medical professional performing a medical procedure). In some embodiments, this blood vessel can be spatially separated from the location of interest. For example, the blood vessel can be located in the patient's thigh or the patient's wrist, and the location of interest can be located in the patient's head, neck, stomach, chest, or surrounding organs. The location of interest can be any location in the body that requires medical treatment with the help of the intravascular device 1. For example, the location of interest can be a location that includes a blood clot, a stenosis, a constricted blood vessel (e.g., a vasospasm), or an aneurysm.

[0091] Next, in step 1104, the intravascular device 1 is advanced or guided through the blood vessel (or multiple blood vessels) until the intravascular device is located at the location of interest. This is achieved, for example, by the user manipulating the actuator control 200 to advance the intravascular device 1. The selectively bendable portion 110 is controlled by the actuator control 200 (which remains outside the patient's body) as needed to guide the intravascular device 1 through various bends present in the blood vessel.

[0092] Once the distal end 2 arrives the position of interest, in step 1106, the selective bending portion 110 at the distal end 2 can be actuated to control the curvature of the tip, thereby producing a tip shape that determines the direction of the tip as required. Additionally or alternatively, the selective bending portion 110 at the distal end 2 can be actuated to increase support and / or provide shape retention, thereby determining the direction of the distal end of the intravascular device. For example, the tip shape can be directed so that it is aligned or aimed at the position of interest. In certain embodiments, this tip shape can be a curved or non-straight shape, a J shape or a serpentine shape. The determination of this direction of the tip shape does not require any additional support to maintain its direction. For example, the support of a blood vessel, an additional guidewire, an additional catheter or an additional intravascular device is not required.

[0093] In some embodiments, the intravascular device 1 is configured to be used as a guidewire, which can be used to guide a catheter through a blood vessel to a location of interest. Therefore, in step 1108, the catheter can be advanced through the blood vessel to perform a related medical procedure at the location of interest. For example, the catheter can be a suction catheter, and the location of interest can be located at or adjacent to the blood clot. After reaching the location of interest, the suction catheter can be used to remove the blood clot by suction or other suitable treatments. These embodiments of the intravascular device 1 can also be used to guide other medical devices to the location of interest in the body that can be accessed through the blood vessel, such as another guidewire, a different type of catheter, or any other suitable system. For example, another device can be a stent extractor, which can be used to remove a blood clot from a blood vessel (using a stent extractor through a microcatheter). According to another example, the catheter can be a microcatheter, and the location of interest can be the location of a clot, the location of an aneurysm, or the location of a narrowed blood vessel (such as vasospasm or stenosis, etc.).

[0094] like Fig.12 As shown, another method for navigating an embodiment of an intravascular device 1 through a vascular system begins at step 1202, where a medical image captured during an intravascular procedure is received. This medical image can be taken by any suitable medical imaging technology, such as, but not limited to, X-ray, CT, or MRI. The image can be stored on a suitable computer or other device.

[0095] In step 1204, the medical image is analyzed to detect target regions where the path of the vascular system to the target vessel changes direction. For example, this may include bends or twists in the vessel that require additional steps to successfully navigate the intravascular device 1. For example, this may be accomplished by visual inspection of the image or by an appropriate algorithm run by a computer. For example, this may be accomplished by a computer vision model trained to recognize blood vessels.

[0096] In step 1206, the medical image is further analyzed to detect the intravascular device 1 extending through the target vessel. This can be accomplished, for example, by visual inspection of the image or by an appropriate algorithm run by a computer. As discussed above, this step can be facilitated by the radiopacity of one or more elements of the intravascular device 1. For example, this can be accomplished by a computer vision model trained to recognize radiopaque elements.

[0097] Once the target area and the intravascular device 1 are located, a determination is made as to whether a particular portion of the intravascular device is located at the target area in step 1208. This can be accomplished using techniques similar to those discussed in steps 1206 and 1208.

[0098] If the specific portion of the intravascular device is located at the target area, then in step 1210, the curvature of the specific portion of the intravascular device 1 is controlled to navigate to the target area. This can be achieved by changing the curvature of the selectively bendable portion 110 as discussed above. The specific portion of the intravascular device 1 can be or include the distal end 2, and the selectively bendable portion 110 can be located at the distal end 2. In these embodiments, the distal end 2 does not shift outside the target area.

[0099] In some embodiments, the intravascular device 1 is configured as a guidewire for guiding a suitable medical device (such as an aspiration catheter) to a target area. In other embodiments, for example, the intravascular device 1 itself is configured as a catheter (eg, a guide catheter).

[0100] After completion of an action, such as a medical treatment, a second medical image may be taken to ensure that the treatment was successful. Additionally or in the alternative, a signal received from a sensor 108 disposed in the intravascular device 1 may be used to determine completion of the action. The sensor 108 may be any suitable sensor and, for example, may function to sense the presence of a clot, type of clot, or type of stenosis in a blood vessel. After completion of the action, the curvature of the intravascular device may be controlled to reverse or modify the initial curvature control step. This allows removal of the intravascular device 1.

[0101] In embodiments of the intravascular device 1 having multiple selectively bendable portions 110, the initial process described above regarding controlling the curvature of a specific portion of each selectively bendable portion 110 may be accomplished using appropriate imaging techniques.

[0102] These steps can also be performed on a suitable computing device having a memory and a processor. Specifically, the evaluation of the imaging and the determination of the relative position of the intravascular device 1 and the target area can be performed by a suitable algorithm stored in the memory and executed by the processor.

[0103] Exemplary embodiments of the present invention are provided further below.

[0104] Example 1

[0105] An intravascular device comprising: a tube including a selectively bendable portion, wherein at least a portion of the tube is configured to be inserted into a blood vessel; a plug disposed at a distal end of the tube, wherein the plug has a rounded tip configured to be inserted into the blood vessel; a gasket disposed between the plug and the tube, the gasket being fixed relative to the tube; and a control element extending through at least a portion of the tube, the distal end of the control element being connected to the gasket, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend.

[0106] Example 2

[0107] An intravascular device comprising: a tube including a selectively bendable portion; a plurality of narrow slots formed in the tube, each of the plurality of narrow slots being disposed partially around the periphery of the tube; a control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend; and a gasket disposed within the tube and placed between the tube and the control element, the gasket comprising a solid object configured to reduce sliding friction between the tube and the control element.

[0108] Example 3

[0109] An intravascular device, comprising: a tube, the tube including a selectively bendable portion, the selectively bendable portion being configured to bend in a first direction; a plurality of narrow slots formed on the selectively bendable portion, wherein the plurality of narrow slots include: a first narrow slot, the first narrow slot facing the first direction, and a second narrow slot, the second narrow slot facing a second direction different from the first direction, such that a first range of the first narrow slot is greater than a second range of the second narrow slot; and a control element, the control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend.

[0110] Example 4

[0111] An intravascular device comprising: a tube including a selectively bendable portion configured to bend in a first direction; a plurality of narrow slots formed on the selectively bendable portion; a control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend; and a friction element formed as a second tube disposed within the tube around the control element and fixed to the second tube of the control element, wherein at least a portion of the second tube contacts an inner wall of the tube to increase friction between the control element and the tube.

[0112] Example 5

[0113] An intravascular device comprising: a tube comprising a first selectively bendable portion and a second selectively bendable portion; a first control element extending through at least a portion of the tube, a distal end of the first control element being connected to the distal end of the first selectively bendable portion, wherein movement of the first control element relative to the tube is configured to cause movement of the first selectively bendable portion; and a second control element extending through at least a portion of the tube, a distal end of the second control element being connected to the distal end of the second selectively bendable portion, wherein movement of the second control element relative to the tube is configured to cause movement of the second selectively bendable portion of the tube.

[0114] Example 6

[0115] An intravascular device according to Example 5, wherein an actuator control is disposed at the proximal end of the tube, the actuator control comprising: a first handle, the first handle being capable of sliding relative to the tube and being connected to the first control element so that the first control element moves with the movement of the first handle; and a second handle, the second handle being capable of sliding relative to the tube and being connected to the second control element so that the second control element moves with the movement of the second handle.

[0116] Example 7

[0117] An intravascular device according to Example 6, wherein the first handle and the second handle are configured to move independently of each other.

[0118] Example 8

[0119] An intravascular device according to any one of Examples 5 to 7, wherein the first control element is formed as a wire or cable, and the second control element is formed as a second tube.

[0120] Example 9

[0121] An intravascular device according to any one of Examples 5 to 8, wherein the second control element is disposed around the first control element.

[0122] Example 10

[0123] An intravascular device according to any one of Examples 6 to 9, wherein movement of the first handle in a first axial direction causes movement of the first selectively bendable portion in a first direction, wherein movement of the first handle in a second axial direction causes movement of the first selectively bendable portion in a second direction, wherein movement of the second handle in the first axial direction causes movement of the second selectively bendable portion in a third direction, and wherein movement of the second handle in the second axial direction causes movement of the second selectively bendable portion in a fourth direction.

[0124] Embodiment 11

[0125] An intravascular device according to any one of Examples 6 to 9, wherein the amplitude of the movement of the first handle corresponds to the amplitude of the movement of the first selectively bendable portion, and wherein the amplitude of the movement of the second handle corresponds to the amplitude of the movement of the second selectively bendable portion.

[0126] Example 12

[0127] An intravascular device according to any one of Examples 5 to 11, wherein the first selectively bendable portion is adjacent to the second selectively bendable portion, or wherein the first selectively bendable portion is separated from the second selectively bendable portion by an inflexible portion of the tube.

[0128] Embodiment 13

[0129] An intravascular device according to any one of Examples 5 to 12, wherein a first friction element is disposed in the tube, the first friction element being configured to increase the friction between the tube and the first control element when the first control element moves relative to the tube; and a second friction element is disposed in the tube, the second friction element being configured to increase the friction between the tube and the second control element when the second control element moves relative to the tube, wherein the first friction element and the second friction element are configured to maintain the positions of the first part of the handle and the second part of the handle, respectively, in the absence of external input on the first part of the handle or the second part of the handle.

[0130] Embodiment 14

[0131] An intravascular device according to any one of Examples 5 to 13, wherein the tube includes a plurality of slots, each of the plurality of slots being disposed partially around a circumference of the tube.

[0132] According to one embodiment, at least one group of slots out of said plurality of slots is disposed at least in said first selectively bendable portion and in said second selectively bendable portion.

[0133] Embodiment 15

[0134] An intravascular device according to any one of Examples 5 to 14, comprising a first gasket disposed within the tube and placed between the tube and the first control element, the first gasket comprising a solid object configured to reduce sliding friction between the tube and the first control element.

[0135] According to one embodiment, the intravascular device includes a second gasket, which is disposed within the tube and placed between the tube and the second control element, and the second gasket includes a solid object, which is configured to reduce the sliding friction between the tube and the second control element and the sliding friction between the second control element and the first control element.

[0136] According to one embodiment, the first shim and the second shim include coils formed from one or more metal wires.

[0137] According to one embodiment, the first gasket and the second gasket are at least partially formed of a material selected from the group consisting of a metal alloy and a fluoropolymer material.

[0138] Example 16

[0139] An intravascular device according to any one of Examples 5 to 15, wherein at least one gasket is disposed in the tube and is fixed relative to the tube, wherein at least one of the following is true: the first control element and the first gasket are connected to the gasket; and the second control element and the second gasket are connected to the gasket.

[0140] Embodiment 17

[0141] An intravascular device according to any one of Examples 5 to 16, wherein the tube further includes a third selectively bendable portion; the intravascular device further includes a third control element, wherein the third control element extends through at least a portion of the tube, and the distal end of the third control element is connected to the distal end of the third selectively bendable portion, wherein movement of the third control element relative to the tube is configured to cause movement of the third selectively bendable portion.

[0142] Example 18A

[0143] An intravascular device according to any one of Examples 1 to 4, wherein at least one gasket is disposed in the tube.

[0144] According to one embodiment, the washer is rotationally fixed relative to the axis of the tube such that application of a torque to the control element causes the selectively bendable portion to bend.

[0145] According to one embodiment, the gasket is disposed in the tube, the gasket being fixed relative to the tube, wherein at least one of the control element and the spacer is connected to the gasket.

[0146] Example 18B

[0147] The intravascular device of any of embodiments 1 to 18A, wherein at least a portion of the tube is radiopaque. According to one embodiment, at least a portion of the tube comprises a material selected from the group consisting of a metal alloy, stainless steel, and a polymer material.

[0148] Embodiment 19

[0149] An intravascular device according to any of Examples 1 to 18B, wherein the control element is configured to slide relative to at least a portion of the tube.

[0150] Embodiment 20

[0151] An intravascular device according to any one of Examples 1 to 19, wherein a control element extends from the gasket at the distal end of the tube, through the tube to the proximal end of the tube.

[0152] Embodiment 21

[0153] An intravascular device according to any one of Examples 1 to 20, wherein a diameter of the control element gradually decreases from the proximal end of the tube to the distal end of the tube.

[0154] Embodiment 22

[0155] An intravascular device according to any one of Examples 1 to 21, wherein a portion of the wire closer to the distal end of the tube has a rectangular cross-section, and a portion of the wire closer to the proximal end of the tube has a circular cross-section.

[0156] Example 22A

[0157] According to the intravascular device of Example 22, the width of the rectangular cross-section of the portion of the control element having the rectangular cross-section increases as the distance from the distal end decreases, and the diameter of the portion of the control element having the circular cross-section decreases as the distance to the distal end increases.

[0158] Example 22B

[0159] According to the intravascular device of Example 22A, the length of the portion of the control element having a rectangular cross-section increases in a step-by-step manner, so that a first width of at least a first step of the control element is larger than a second width of a second step of the control element, and wherein the first step is closer to the distal end than the second step.

[0160] Embodiment 23

[0161] An intravascular device according to any one of Examples 1 to 22B, wherein a gasket is disposed within the tube and placed between the tube and the control element, the gasket comprising a solid object configured to reduce sliding friction between the tube and the control element, and wherein the gasket is connected to the washer.

[0162] According to one embodiment, said spacer circumferentially surrounds at least a portion of said wire.

[0163] According to one embodiment, the spacer comprises a metal wire formed into a coil.

[0164] According to one embodiment, the spacer comprises a plurality of metal wires forming a coil.

[0165] According to one embodiment, the coil has a first portion, a second portion and a third portion, each of the first portion, the second portion and the third portion having a different diameter.

[0166] According to one embodiment, the spacer comprises a second tube placed between the wire and the tube.

[0167] According to one embodiment, the second tube has a first portion, a second portion and a third portion, each of the first portion, the second portion and the third portion having a different diameter.

[0168] According to one embodiment, said tube circumferentially surrounds at least a portion of said second tube.

[0169] According to one embodiment, the spacer is at least partially formed from a radiopaque material.

[0170] Embodiment 24

[0171] An intravascular device according to any one of Examples 1 to 23, wherein the tube includes a plurality of slots, each of the plurality of slots being disposed partially around a circumference of the tube.

[0172] According to one embodiment, at least one group of slots out of said plurality of slots is disposed in said selectively bendable portion.

[0173] Embodiment 25

[0174] An intravascular device according to any one of embodiments 1 to 24, wherein at least two of the plurality of slots are disposed in the selectively bendable portion, wherein a first group of slots including one of the two slots faces a first direction, and a second group of slots including the other of the two slots faces a second direction different from the first direction, such that a first range of each slot in the first group of slots is greater than a second range of each slot in the second group of slots.

[0175] According to one embodiment, the area of ​​each slot in the first group of slots is greater than the area of ​​each slot in the second group of slots.

[0176] According to one embodiment, the shape of each slot of the first set of slots is different from the shape of each slot of the second set of slots.

[0177] According to one embodiment, the difference in range between the first set of slots and the second set of slots biases the selectively bendable portion to bend in the first direction when the wire moves.

[0178] According to one embodiment, a second plurality of slots is formed on a portion of the tube separated from the selectively bendable portion, wherein the second plurality of slots are symmetrically distributed around the tube, and wherein the second plurality of slots enhances flexibility of the tube in the portion.

[0179] According to one embodiment, the second direction is oriented to face in a radial direction different from the first direction.

[0180] According to one embodiment, the distance between the third and fourth slots adjacent to each other is smaller than the distance between the fifth and sixth slots adjacent to each other, wherein the fifth and sixth slots are closer to the proximal end of the tube than the third and fourth slots.

[0181] Embodiment 26

[0182] According to the intravascular device described in any one of Examples 1 to 25, the tube further includes an inflexible portion configured to remain in an unbend configuration when the selectively bendable portion is bent.

[0183] According to one embodiment, the inflexible portion is adjacent to the selectively bendable portion.

[0184] According to one embodiment, the inflexible portion is separated from the selectively bendable portion by a third portion of the tube.

[0185] Embodiment 27

[0186] An intravascular device according to any one of Examples 1 to 26, wherein a plug is disposed at a distal end of the tube, wherein the plug has a rounded tip configured to be inserted into a blood vessel.

[0187] Embodiment 28

[0188] An intravascular device according to any one of Examples 1 to 27, wherein an actuator control is disposed at the proximal end of the tube, the actuator control comprising a handle which is capable of sliding relative to the tube and is connected to the control element so that the control element moves with the movement of the handle.

[0189] Embodiment 29

[0190] An intravascular device according to any one of Examples 1 to 28, wherein a friction element is disposed in the tube, the friction element being configured to increase friction between the tube and the wire when the wire moves relative to the tube.

[0191] According to one embodiment, the friction element is configured to maintain the position of the handle in the absence of external input on the handle.

[0192] According to one embodiment, the friction element is formed as a second tube which is arranged around the control element within the tube and fixed to the control element, wherein at least a portion of the second tube contacts an inner wall of the tube to increase friction between the control element and the tube.

[0193] According to one embodiment, the second tube is formed to have at least one angle such that a portion of the second tube including the angle contacts the inner wall of the tube.

[0194] Embodiment 30

[0195] A method for navigating an intravascular device through a vascular system, the method comprising: receiving a medical image captured during an endovascular procedure; analyzing the medical image to detect a target region where a path of the vascular system to a target vessel changes direction; evaluating the medical image to detect an intravascular device along the path; determining that a specific portion of the intravascular device is located at the target region; and controlling the curvature of the specific portion of the intravascular device.

[0196] Embodiment 31

[0197] A method for navigating a catheter through a blood vessel, the method comprising: guiding an intravascular device configured as a guidewire through the blood vessel to a location of interest, wherein the intravascular device includes a selectively bendable portion; positioning the intravascular device at the location of interest, wherein the location of interest includes a location along the blood vessel; actuating the selectively bendable portion of the intravascular device to form a tip shape, increase support and / or provide shape retention to determine the direction of the selectively bendable portion of the intravascular device; and advancing the catheter over the guidewire to navigate the catheter through the blood vessel to the location of interest.

[0198] Embodiment 32

[0199] A method according to embodiment 30 or 31, wherein the method includes: examining the medical image to detect the distal tip of the intravascular device; and determining that the specific portion of the intravascular device is located at the target area based on the relative position of the distal tip and the target area.

[0200] Example 33A

[0201] A method according to any of Examples 30 or 32, wherein the intravascular device is a catheter or a guidewire.

[0202] Example 33B

[0203] A method according to any one of Examples 30 to 33A, wherein the catheter comprises an aspiration catheter or a microcatheter.

[0204] Example 34A

[0205] According to the method described in any one of Examples 30 to 33B, the specific portion of the intravascular device includes a selectively bendable portion.

[0206] According to one embodiment, the intravascular device includes: a tube including the selectively bendable portion; and a control element extending through the tube and connected to a distal portion of the selectively bendable portion.

[0207] According to one embodiment, the tube comprises a plurality of slots.

[0208] According to one embodiment, the selectively bendable portion comprises a plurality of slots.

[0209] According to one embodiment, at least a portion of the tube comprises a radiopaque material.

[0210] According to one embodiment, the selectively bendable portion comprises a radiopaque material.

[0211] Example 34B

[0212] According to the method described in any one of Examples 30 to 34A, when the intravascular device is a guidewire, the guidewire includes a tube located proximal to the selectively bendable portion, and a control element extending from the selectively bendable portion through the proximal end of the tube.

[0213] According to one embodiment, the selectively bendable portion of the guidewire comprises a distal tip.

[0214] According to one embodiment, the distal tip of the guidewire is sealed.

[0215] According to one embodiment, the guidewire comprises a spacer placed between the control element and the tube.

[0216] According to one embodiment, the spacer comprises a coil formed by one or more metal wires.

[0217] Embodiment 35

[0218] The method of any one of Examples 30-34B, wherein the intravascular device is the intravascular device of any one of Examples 1-29.

[0219] Embodiment 36

[0220] A method according to any one of Examples 30 to 35, wherein at least a portion of the particular portion of the intravascular device is radiopaque.

[0221] Embodiment 37

[0222] According to the method described in any one of Examples 30 to 36, the method includes determining that the specific portion of the intravascular device is located at the target area based on the radiopacity of the specific portion.

[0223] Embodiment 38

[0224] A method according to any one of Examples 30 to 37, wherein controlling the curvature of the specific portion of the intravascular device includes applying tension to a control element connected to the specific portion of the intravascular device.

[0225] According to one embodiment, controlling the curvature comprises moving the control element to bend the selectively bendable portion.

[0226] Embodiment 39

[0227] According to the method described in any one of Examples 30 to 38, the method includes: causing an action involving the distal tip of the intravascular device after controlling the curvature of the specific portion of the intravascular device; and controlling the curvature of the specific portion of the intravascular device after causing the action.

[0228] According to one embodiment, the method includes: receiving a second medical image captured during the endovascular procedure after inducing the action; and analyzing the second medical image to determine completion of the action.

[0229] According to one embodiment, the method includes: receiving a signal from a sensor included in the intravascular device after inducing the action; and analyzing the signal to determine completion of the action.

[0230] According to one embodiment, the signal is at least one of a digital electromagnetic signal, an analog electromagnetic signal, and a mechanical signal.

[0231] According to one embodiment, the action involves the distal tip of the intravascular device in the target vessel.

[0232] Embodiment 40

[0233] According to the method described in any one of Examples 30 to 39, the method includes: analyzing the medical image to detect a second target area; examining the medical image to determine that the second portion of the intravascular device is located at the second target area; and controlling the curvature of the second portion of the intravascular device while controlling the curvature of the specific portion of the intravascular device.

[0234] According to one embodiment, the specific portion and the second portion of the intravascular device are at least one centimeter apart.

[0235] According to one embodiment, at least a portion of the second portion of the intravascular device is radiopaque.

[0236] According to one embodiment, the method includes determining that the second portion of the intravascular device is located at the second target area is based on a radiopacity of the second portion.

[0237] According to one embodiment, controlling the curvature of the specific portion of the intravascular device or controlling the curvature of the second portion of the intravascular device does not cause a change in the curvature of at least one other portion of the intravascular device.

[0238] According to one embodiment, at least one other portion of the intravascular device is located distally to the specific portion of the intravascular device and the second portion of the intravascular device.

[0239] Embodiment 41

[0240] According to the method of any one of Examples 31 or 33 to 40, the method includes advancing the catheter over the guidewire.

[0241] According to one embodiment, advancing the catheter over the guidewire enables the catheter to be deflected without additional support.

[0242] According to one embodiment, the additional support comprises any one of a blood vessel, a second catheter, a second microcatheter or a second guidewire.

[0243] According to one embodiment, the blood vessel comprises at least one of a curve, an angle, a loop, and a helical twist.

[0244] According to one embodiment, the blood vessel is a cerebral blood vessel.

[0245] Embodiment 42

[0246] According to any one of the methods of Examples 31 to 41, the location of interest is adjacent to a blood clot.

[0247] According to one embodiment, when the device is a guidewire, the guidewire does not cross to a location distal to the blood clot.

[0248] Embodiment 43

[0249] According to the method of any one of Examples 30 to 42, the method includes removing the blood clot from the blood vessel by applying suction to the catheter (e.g., a suction catheter).

[0250] Embodiment 44

[0251] A method according to any one of Examples 34 to 43, wherein the control element is connected to a distal segment of the selectively bendable portion.

[0252] According to one embodiment, the control element is configured to selectively bend the selectively bendable portion of the guidewire by applying tension to the control element via an actuation force transmitted via a distal end of the control element.

[0253] According to one embodiment, the proximal end of the control element is connected to an actuator control.

[0254] According to one embodiment, the actuator control is configured to exert the actuation force on the proximal end of the control element to cause relative movement between the control element and the tube to actuate the selectively bendable portion.

[0255] Embodiment 50

[0256] A non-transitory computer-readable medium containing instructions for causing at least one processor to perform operations for selectively deflecting different portions of an intravascular device, the operations comprising: receiving a medical image captured during an intravascular procedure; analyzing the medical image to detect a target area where a curvature of the intravascular device needs to be changed to facilitate navigation through a target vessel; evaluating the medical image to detect the intravascular device extending through the target vessel; determining that a particular portion of the intravascular device is located at the target area; and controlling the curvature of the particular portion of the intravascular device.

[0257] Embodiment 51

[0258] A non-transitory computer-readable medium containing instructions for causing at least one processor to perform operations for selectively deflecting different portions of an intravascular device, the operations comprising: guiding an intravascular device configured as a guidewire through the blood vessel to a location of interest, wherein the intravascular device includes a selectively bendable portion; positioning the intravascular device at the location of interest, wherein the location of interest includes a location along the blood vessel; actuating the selectively bendable portion of the intravascular device to form a tip shape, increase support and / or provide shape retention to determine the direction of the selectively bendable portion of the intravascular device; and advancing the catheter over the guidewire to the location of interest to navigate the catheter through the blood vessel by advancing the catheter over the guidewire to the location of interest.

[0259] It should be understood that the Detailed Description section, rather than the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more exemplary embodiments of the invention contemplated by the inventors, but not all exemplary embodiments, and therefore, are not intended to limit the invention and the appended claims in any way. In addition, the examples described above do not limit the present disclosure to what has been specifically shown and described above. On the contrary, the scope of the present disclosure includes combinations and sub-combinations of the various features described above and variations and modifications thereof, which would occur to a person skilled in the art after reading the foregoing description and which are not disclosed in the prior art.

[0260] The use of the modifiers "about" or "approximately" in this disclosure is intended to indicate that the associated elements are subject to variations in tolerance ranges. Unless otherwise defined, the use of these modifiers with respect to a unit of measurement means a tolerance of plus or minus ten percent of the unit of measurement. The use of these modifiers with respect to descriptions such as shape is intended to allow for variations in the shape due to tolerance issues, as occurs in the art as is generally understood.

[0261] The foregoing description of the specific embodiments will fully disclose the general nature of the present invention, so that without departing from the general concept of the present invention, others can easily modify and / or adapt such specific embodiments for various applications by applying the knowledge within the art without undue experimentation. Therefore, based on the teachings and guidance presented herein, such adaptations and modifications are intended to be within the meaning and scope of the equivalents of the disclosed embodiments. It should be understood that the wording or terminology herein is for descriptive rather than restrictive purposes, so that the terms or wording of this specification will be interpreted by the technician in view of teaching and guidance.

[0262] Various features of the invention described in the context of separate embodiments for the purpose of clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for the sake of brevity may also be provided separately or in any suitable sub-combination.

[0263] The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. An intravascular device, characterized in that: It includes: a tube comprising a selectively bendable portion, wherein at least a portion of the tube is configured to be inserted into a blood vessel; a plug disposed at a distal end of the tube, wherein the plug has a rounded tip configured to be inserted into the blood vessel; a gasket disposed between the plug and the tube, the gasket being fixed relative to the tube; as well as A control element extends through at least a portion of the tube, the distal end of the control element being coupled to the gasket, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend.

2. The device according to claim 1, characterized in that The washer is rotationally fixed relative to the axis of the tube such that application of torque to the control element causes the selectively bendable portion of the tube to bend.

3. The intravascular device according to claim 1 or 2, characterized in that: The control element is configured to slide relative to at least a portion of the tube.

4. The intravascular device according to any one of claims 1 to 3, characterized in that: The control element extends from the gasket at the distal end of the tube through the tube to the proximal end of the tube.

5. The intravascular device according to claim 4, characterized in that The control element has a diameter that gradually decreases from the proximal end of the tube to the distal end of the tube.

6. The intravascular device according to any one of claims 1 to 5, characterized in that: A portion of the control element closer to the distal end of the tube has a rectangular cross-section, and a portion of the control element closer to the proximal end of the tube has a circular cross-section.

7. The intravascular device according to claim 6, characterized in that The portion of the control element having the rectangular cross-section has a width of the rectangular cross-section that increases with increasing distance from the distal end, and wherein the portion of the control element having the circular cross-section has a diameter that decreases with increasing distance from the distal end.

8. The intravascular device according to claim 7, characterized in that The width of the portion of the control element having a rectangular cross-section decreases in a step-like manner, such that a first width of at least a first step of the control element is greater than a second width of a second step of the control element, and wherein the first step is closer to the distal end than the second step.

9. The intravascular device according to any one of claims 1 to 8, characterized in that: It further includes a gasket disposed within the tube and positioned between the tube and the control element, the gasket comprising a solid object configured to reduce sliding friction between the tube and the control element, and wherein the gasket is connected to the washer.

10. The intravascular device according to any one of claims 1 to 9, characterized in that: The tube includes a plurality of slots, each of the plurality of slots being disposed partially around a circumference of the tube.

11. An intravascular device, characterized in that: It includes: a tube including a selectively bendable portion; a plurality of slots formed in the tube, each slot of the plurality of slots being disposed partially around a circumference of the tube; a control element extending through the tube, the control element coupled to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend; as well as A gasket is disposed within the tube and positioned between the tube and the control element, the gasket comprising a solid object configured to reduce sliding friction between the tube and the control element.

12. The intravascular device according to claim 9 or 11, characterized in that: The gasket circumferentially surrounds at least a portion of the control element.

13. The intravascular device according to any one of claims 9, 11 or 12, characterized in that: The spacer includes a metal wire formed into a coil.

14. The intravascular device according to any one of claims 9, 11 or 12, characterized in that: The spacer includes a plurality of wires formed into a coil.

15. The intravascular device according to any one of claims 9, 11 or 12, characterized in that: The spacer includes a second tube placed between the control element and the tube.

16. The intravascular device according to claim 15, characterized in that The tube circumferentially surrounds at least a portion of the second tube.

17. The intravascular device according to claim 13 or 14, characterized in that: The coil has a first portion, a second portion, and a third portion, each of the first portion, the second portion, and the third portion having a different diameter.

18. The intravascular device according to claim 15, characterized in that The second tube has a first portion, a second portion, and a third portion, each of the first portion, the second portion, and the third portion having a different diameter.

19. The intravascular device according to claim 9 or any one of claims 11 to 18, characterized in that: The spacer is at least partially formed from a radiopaque material.

20. The intravascular device according to any one of claims 11 to 19, characterized in that It further includes a plug disposed at the distal end of the tube, wherein the plug has a rounded tip configured to be inserted into a blood vessel.

21. The intravascular device according to any one of claims 11 to 20, characterized in that It further includes a gasket disposed in the tube, the gasket being fixed relative to the tube, wherein at least one of the control element and the spacer is connected to the gasket.

22. The intravascular device according to any one of claims 1 to 21, characterized in that It further comprises an actuator control disposed at the proximal end of the tube, the actuator control comprising: A handle is slidable relative to the tube and is connected to the control element so that the control element moves with movement of the handle.

23. The intravascular device according to any one of claims 1 to 22, characterized in that It further includes a friction element disposed in the tube, the friction element being configured to increase friction between the tube and the control element when the control element moves relative to the tube.

24. The intravascular device according to claim 23, characterized in that The friction element is configured to maintain a position of the handle in the absence of an external input on the handle.

25. The intravascular device according to claim 23 or 24, characterized in that The friction element is formed as a second tube disposed around the control element within the tube and fixed to the control element, wherein at least a portion of the second tube contacts an inner wall of the tube to increase friction between the control element and the tube.

26. The intravascular device according to any one of claims 10 to 25, characterized in that At least two of the plurality of slots are disposed in the selectively bendable portion, wherein a first group of slots including one of the two slots faces in a first direction, and A second group of slots including the other of the two slots faces in a second direction different from the first direction such that a first extent of each slot in the first group of slots is greater than a second extent of each slot in the second group of slots.

27. The intravascular device according to claim 26, characterized in that The area of ​​each slot in the first set of slots is greater than the area of ​​each slot in the second set of slots.

28. The intravascular device according to claim 27, characterized in that The shape of each slot in the first set of slots is different from the shape of each slot in the second set of slots.

29. The intravascular device according to claim 27 or 28, characterized in that The second direction is oriented to face in a radial direction opposite to the first direction.

30. The intravascular device according to any one of claims 1 to 29, characterized in that The tube further includes an inflexible portion configured to remain in an unbendable configuration when the selectively bendable portion is bent.

31. The intravascular device according to claim 30, characterized in that The inflexible portion is adjacent to the selectively bendable portion.

32. The intravascular device according to claim 30, characterized in that The inflexible portion is separated from the selectively bendable portion by a third portion of the tube.

33. An intravascular device, characterized in that: It includes: a tube comprising a first selectively bendable portion and a second selectively bendable portion; a first control element extending through at least a portion of the tube, a distal end of the first control element coupled to a distal end of the first selectively bendable portion, wherein movement of the first control element relative to the tube is configured to cause movement of the first selectively bendable portion; as well as A second control element extends through at least a portion of the tube, a distal end of the second control element connected to the distal end of the second selectively bendable portion, wherein movement of the second control element relative to the tube is configured to cause movement of the second selectively bendable portion of the tube.

34. The intravascular device according to claim 33, characterized in that It further comprises an actuator control disposed at the proximal end of the tube, the actuator control comprising: a first handle slidable relative to the tube and connected to the first control element such that the first control element moves with movement of the first handle; and A second handle is slidable relative to the tube and is connected to the second control element so that the second control element moves with movement of the second handle.

35. The intravascular device according to claim 34, characterized in that The first handle and the second handle are configured to move independently of each other.

36. The intravascular device according to any one of claims 33 to 35, characterized in that The first control element is formed as a wire or cable and the second control element is formed as a second tube.

37. The intravascular device according to claim 36, characterized in that The second control element is disposed around the first control element.

38. The intravascular device according to any one of claims 33 to 37, characterized in that Movement of the first handle in a first axial direction causes movement of the first selectively bendable portion in a first direction, wherein movement of the first handle in a second axial direction causes movement of the first selectively bendable portion in a second direction, wherein movement of the second handle in the first axial direction causes movement of the second selectively bendable portion in a third direction, and Wherein movement of the second handle in the second axial direction causes movement of the second selectively bendable portion in a fourth direction.

39. The intravascular device according to claim 38, characterized in that The magnitude of the movement of the first handle corresponds to the magnitude of the movement of the first selectively bendable portion.

40. The intravascular device according to claim 38, characterized in that The magnitude of the movement of the second handle corresponds to the magnitude of the movement of the second selectively bendable portion.

41. The intravascular device according to any one of claims 33 to 40, characterized in that The first selectively bendable portion is adjacent to the second selectively bendable portion.

42. The intravascular device according to any one of claims 33 to 40, characterized in that The first selectively bendable portion is separated from the second selectively bendable portion by a non-bendable portion of the tube.

43. The intravascular device according to any one of claims 33 to 42, characterized in that It further includes: a first friction element disposed in the tube, the first friction element configured to increase friction between the tube and the first control element when the first control element moves relative to the tube; and a second friction element disposed in the tube, the second friction element being configured to increase friction between the tube and the second control element when the second control element moves relative to the tube, The first friction element and the second friction element are configured to maintain the position of the first portion of the handle and the second portion of the handle, respectively, in the absence of an external input on the first portion of the handle or the second portion of the handle.

44. The intravascular device according to any one of claims 33 to 43, characterized in that It further includes a plug disposed at the distal end of the tube, wherein the plug has a rounded tip configured to be inserted into a blood vessel.

45. The intravascular device according to any one of claims 33 to 44, characterized in that The tube includes a plurality of slots, each of the plurality of slots being disposed partially around a circumference of the tube.

46. ​​The intravascular device according to any one of claims 10 to 45, characterized in that A distance between a third slot among the plurality of slots and a fourth slot among the plurality of slots that are adjacent to each other is smaller than a distance between a fifth slot among the plurality of slots and a sixth slot among the plurality of slots that are adjacent to each other, wherein the fifth slot and the sixth slot are closer to the proximal end of the tube than the third slot and the fourth slot.

47. The intravascular device according to claim 45, characterized in that At least one slot of the plurality of slots is disposed in one of the first selectively bendable portion and the second selectively bendable portion.

48. The intravascular device according to any one of claims 33 to 47, characterized in that It further includes a first gasket disposed within the tube and positioned between the tube and the first control element, the first gasket including a solid object configured to reduce sliding friction between the tube and the first control element.

49. The intravascular device according to claim 48, characterized in that It further includes a second gasket, which is disposed in the tube and placed between the tube and the second control element, and the second gasket includes a solid object, which is configured to reduce the sliding friction between the tube and the second control element and the sliding friction between the second control element and the first control element.

50. The intravascular device according to claim 48 or 49, characterized in that The first shim and the second shim include coils formed from one or more metal wires.

51. The intravascular device according to claim 48 or 49, characterized in that The first gasket and the second gasket are at least partially formed of a material selected from the group consisting of a metal alloy and a fluoropolymer material.

52. The intravascular device according to claim 48 or 49, characterized in that It further comprises at least one gasket disposed in the tube, the gasket being fixed relative to the tube, wherein at least one of the following is true: the first control element and the first spacer are connected to the washer; and The second control element and the second spacer are connected to the washer.

53. The intravascular device according to any one of claims 33 to 52, characterized in that The tube further includes a third selectively bendable portion; The intravascular device further includes a third control element extending through at least a portion of the tube, the distal end of the third control element being connected to the distal end of the third selectively bendable portion, wherein movement of the third control element relative to the tube is configured to cause movement of the third selectively bendable portion.

54. A method for navigating an intravascular device through a vascular system, characterized in that The method comprises: receiving a medical image captured during an endovascular procedure; analyzing the medical image to detect a target region where a path of the vascular system to a target vessel changes direction; evaluating the medical image to detect an intravascular device along the pathway; determining that a particular portion of the intravascular device is located at the target area; and The curvature of the particular portion of the intravascular device is controlled.

55. The method according to claim 54, characterized in that It further includes: examining the medical image to detect a distal tip of the intravascular device; and The particular portion of the intravascular device is determined to be located at the target area based on the relative positions of the distal tip and the target area.

56. The method according to claim 54 or 55, characterized in that At least a portion of the particular portion of the intravascular device is radiopaque.

57. The method according to claim 56, characterized in that Determining that the particular portion of the intravascular device is located at the target area is based on a radiopacity of the particular portion.

58. The method according to any one of claims 56 to 57, characterized in that Controlling the curvature of the particular portion of the intravascular device includes applying tension to a control element coupled to the particular portion of the intravascular device.

59. The method according to any one of claims 54 to 58, characterized in that The intravascular device is a catheter.

60. The method according to any one of claims 54 to 58, characterized in that The intravascular device is a guidewire.

61. The method according to any one of claims 54 to 58, characterized in that The particular portion of the intravascular device includes a selectively bendable portion.

62. The method according to claim 61, characterized in that The intravascular device comprises: a tube including the selectively bendable portion; and A control element extends through the tube and is connected to a distal portion of the selectively bendable portion.

63. The method according to any one of claims 61 to 62, characterized in that Controlling the curvature includes moving the control element to bend the selectively bendable portion.

64. The method according to any one of claims 54 to 63, characterized in that It further includes: causing an action involving a distal tip of the intravascular device after controlling the curvature of the particular portion of the intravascular device; and After causing the action, the curvature of the specific portion of the intravascular device is controlled.

65. The method according to claim 64, characterized in that It further includes: receiving, after inducing the action, a second medical image captured during the endovascular procedure; and The second medical image is analyzed to determine completion of the action.

66. The method according to claim 64 or 65, characterized in that It further includes: After causing the action, receiving a signal from a sensor included in the intravascular device; and The signal is analyzed to determine completion of the action.

67. The method according to claim 66, characterized in that The signal is at least one of a digital electromagnetic signal, an analog electromagnetic signal, and a mechanical signal.

68. The method according to any one of claims 64 to 67, characterized in that The action involves the distal tip of the intravascular device in the target vessel.

69. The method according to any one of claims 54 to 68, characterized in that It further includes: analyzing the medical image to detect a second target region; examining the medical image to determine that a second portion of the intravascular device is located at the second target area; and The curvature of the second portion of the intravascular device is controlled while controlling the curvature of the particular portion of the intravascular device.

70. The method according to claim 69, characterized in that The particular portion and the second portion of the intravascular device are at least one centimeter apart.

71. The method according to claim 69 or 70, characterized in that At least a portion of the second portion of the intravascular device is radiopaque.

72. The method according to claim 71, characterized in that Determining that the second portion of the intravascular device is located at the second target area is based on radiopacity of the second portion.

73. The method according to any one of claims 69 to 72, characterized in that Controlling the curvature of the particular portion of the intravascular device or controlling the curvature of the second portion of the intravascular device does not cause a change in the curvature of at least one other portion of the intravascular device.

74. The method according to claim 73, characterized in that The at least one other portion of the intravascular device is located distal to the particular portion of the intravascular device and the second portion of the intravascular device.

75. A non-transitory computer readable medium, characterized in that The device contains instructions for causing at least one processor to perform operations for selectively deflecting different portions of an intravascular device, the operations comprising: receiving a medical image captured during an endovascular procedure; analyzing the medical images to detect a target area requiring a change in curvature of an intravascular device to facilitate navigation through the target vessel; evaluating the medical image to detect the intravascular device extending through the target blood vessel; determining that a particular portion of the intravascular device is located at the target area; and The curvature of the particular portion of the intravascular device is controlled.

76. A method for navigating a catheter through a blood vessel, characterized in that The method comprises: guiding an intravascular device configured as a guidewire through the blood vessel to a location of interest, wherein the intravascular device includes a selectively bendable portion; positioning the intravascular device at the location of interest, wherein the location of interest comprises a location along the blood vessel; actuating the selectively bendable portion of the intravascular device to form a tip shape, increase support, and / or provide shape retention to orient the selectively bendable portion of the intravascular device; and The catheter is advanced over the guidewire to navigate the catheter through the blood vessel to the location of interest.

77. The method according to claim 76, characterized in that The catheter comprises a suction catheter.

78. The method according to claim 76, characterized in that The catheter comprises a microcatheter.

79. The method according to any one of claims 76 to 78, characterized in that Advancing the catheter over the guidewire enables the catheter to deflect without additional support.

80. The method according to claim 79, characterized in that The additional support comprises any one of a blood vessel, a second catheter, a second microcatheter, or a second guidewire.

81. The method according to any one of claims 76 to 80, characterized in that The blood vessel includes at least one of a curve, an angle, a loop, and a helical twist.

82. The method according to any one of claims 76 to 81, characterized in that The location of interest is adjacent to a blood clot.

83. The method according to claim 82, characterized in that It further includes: The blood clot is removed from the blood vessel by applying suction to the aspiration catheter.

84. The method according to claim 82 or 83, characterized in that The guidewire does not cross to a location distal to the clot.

85. The method according to any one of claims 76 to 84, characterized in that The blood vessel is a cerebral blood vessel.

86. The method according to any one of claims 76 to 85, characterized in that The guidewire includes a tube proximal to the selectively bendable portion, and a control element extending from the selectively bendable portion through a proximal end of the tube.

87. The method according to claim 86, characterized in that The control element is connected to a distal section of the selectively bendable portion.

88. The method according to claim 87, characterized in that The control element is configured to selectively bend the selectively bendable portion of the guidewire by applying tension to the control element via an actuation force transmitted via a distal end of the control element.

89. The method according to any one of claims 87 to 88, characterized in that The proximal end of the control element is connected to an actuator control.

90. The method according to claim 89, characterized in that The actuator control is configured to apply the actuation force on the proximal end of the control element to cause relative movement between the control element and the tube to actuate the selectively bendable portion.

91. The method according to any one of claims 76 to 90, characterized in that The selectively bendable portion of the guidewire includes a distal tip.

92. The method according to claim 91, characterized in that The distal tip of the guidewire is sealed.

93. The method according to any one of claims 76 to 92, characterized in that The tube includes a plurality of slots.

94. The method according to any one of claims 76 to 93, characterized in that The selectively bendable portion includes a radiopaque material.

95. The method according to any one of claims 76 to 94, characterized in that The selectively bendable portion includes a plurality of slots.

96. The method according to any one of claims 76 to 95, characterized in that The guidewire includes a spacer placed between the control element and the tube.

97. The method according to claim 96, characterized in that The spacer includes a coil formed from one or more metal wires.

98. A non-transitory computer readable medium, characterized in that The device contains instructions for causing at least one processor to perform operations for selectively deflecting different portions of an intravascular device, the operations comprising: guiding an intravascular device configured as a guidewire through the blood vessel to a location of interest, wherein the intravascular device includes a selectively bendable portion; positioning the intravascular device at the location of interest, wherein the location of interest comprises a location along the blood vessel; actuating the selectively bendable portion of the intravascular device to form a tip shape, increase support, and / or provide shape retention to orient the selectively bendable portion of the intravascular device; and The catheter is advanced over the guidewire to the location of interest to navigate the catheter through the blood vessel by advancing the catheter over the guidewire to the location of interest.

99. An intravascular device, characterized in that: It includes: a tube comprising a selectively bendable portion configured to bend in a first direction; a plurality of slots formed on the selectively bendable portion, wherein the plurality of slots comprises: a first slot of the plurality of slots, the first slot facing the first direction, and a second slot of the plurality of slots, the second slot facing in a second direction different from the first direction such that a first extent of the first slot is greater than a second extent of the second slot; as well as A control element extends through the tube, the control element connected to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend.

100. The intravascular device according to any one of claims 26 and 99, characterized in that The difference in range between the first slot and the second slot biases the selectively bendable portion to bend in the first direction when the wire moves.

101. The intravascular device according to any one of claims 26 and 99, characterized in that It further includes a second plurality of slots formed on a portion of the tube separate from the selectively bendable portion, wherein the second plurality of slots are symmetrically distributed around the tube, and Wherein the second plurality of slots enhances flexibility of the tube in the portion.

102. An intravascular device, characterized in that: It includes: a tube comprising a selectively bendable portion configured to bend in a first direction; a plurality of slots formed on the selectively bendable portion; a control element extending through the tube, the control element coupled to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion to bend; as well as A friction element is formed as a second tube, which is disposed around the control element within the tube and fixed to the control element, wherein at least a portion of the second tube contacts an inner wall of the tube to increase friction between the control element and the tube.

103. The intravascular device according to claim 102, characterized in that The second tube is formed to have at least one angle so that a portion of the second tube including the angle contacts the inner wall of the tube.

104. The intravascular device according to any one of claims 1 to 103, characterized in that At least a portion of the tube includes a material selected from the group consisting of a metal alloy, stainless steel, and a polymer material.

105. The intravascular device according to any one of claims 1 to 103, characterized in that At least a portion of the tube is radiopaque.

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