Intravascular device

Abstract

An intravascular device for inducing blood vessels includes a tube having a selectively bendable portion. The selectively bendable portion can be mechanically actuated via an actuator control unit installed in the tube. The selectively bendable portion can be actuated to improve the guidance of the intravascular device through a curved or twisted portion of the blood vessel.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] The following applications, namely U.S. Provisional Patent Application No. 63 / 389,271, filed on July 14, 2022, and U.S. Provisional Patent Application No. 63 / 409,562, filed on September 23, 2022, are hereby incorporated by reference in their entirety.

[0002] Background

[0002] 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 a target region within the patient's body for performing a medical procedure.

Background Art

[0003]

[0003] An example of the type of intravascular treatment related to the present disclosure is the use of intravascular devices such as catheters to treat stenosis, occlusion, or bleeding in blood vessels including neurovascular, cardiovascular, and peripheral blood vessels. For example, the treatment of acute stroke caused by occlusion of blood vessels in the brain typically involves either the intra - arterial administration of a thrombolytic agent such as recombinant tissue plasminogen activator (rtPA), the mechanical removal of the occlusion, or a combination of the two. These interventional treatments must be performed within a few hours of the onset of symptoms. Both intra - arterial (IA) thrombolytic therapy and interventional thrombectomy involve accessing the occluded cerebral artery via intravascular techniques and devices.

[0004]

[0004] Devices used in these endovascular procedures can include balloons, snares, coils, stents, temporary stents (including those referred to as "stent retrievers"), aspiration of thrombus (with or without concomitant disruption of the thrombus, e.g., by use of a suction catheter), or combinations thereof, depending on the condition to be treated and its anatomical location. Guide catheters, guide sheaths, or guide wires are typically used to introduce, guide, and / or position interventional devices into the peripheral, cardiovascular, and neurovascular systems from an arterial access site such as the femoral artery or the radial artery. These medical devices are often used in a nested fashion, i.e., a guide wire within a microcatheter within an intermediate catheter is advanced as an assembly to the target site.

[0005]

[0005] Notably, for an endovascular device to function effectively, it is necessary to position the device as close as possible to the source of the obstruction, such as a blood clot or a stenotic blood vessel site. This can be difficult in anatomical regions that include tortuous anatomical structures such as blood vessels in the brain. With existing guide wire devices, it is often necessary for a medical practitioner to manually change the curvature of the tip of the device before inserting the device into the blood vessel, for the medical practitioner to replace the device with another, more suitable guide wire during the procedure, or to remove the guide wire, change its shape, and reintroduce it to the patient. Further, these devices often have difficulty overcoming distal tortuous anatomical structures, particularly due to a lack of support or rigidity at the distal end of the catheter and a lack of ability to navigate through these undulating blood vessels.

Summary of the Invention

Means for Solving the Problems

[0006] Summary of the Invention

[0006] In the first embodiment, the intravascular device includes a tube having a selectively bendable portion, at least a portion of the tube being configured to be inserted into a blood vessel, a plug disposed at a distal end of the tube, the plug having a rounded tip configured to be inserted into a blood vessel, a washer disposed between the plug and the tube, the washer being fixed to the tube, and a control element extending through at least a portion of the tube, a distal end of the control element being connected to the washer and configured to bend the selectively bendable portion of the tube by movement of the control element relative to the tube.

[0007]

[0007] In the second embodiment, the intravascular device includes a tube having a selectively bendable portion, a plurality of slots formed in the tube, each of the slots being partially disposed around the tube, a control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion and configured to bend the selectively bendable portion by movement of the control element relative to the tube, and a spacer disposed within the tube and positioned between the tube and the control element, the spacer being configured to reduce sliding friction between the tube and the control element.

[0008]

[0008] A method of controlling the stiffness of an intravascular device according to an embodiment of the present disclosure begins by receiving a medical image taken during an intravascular procedure. The medical image is analyzed to detect a target region where the path of the vasculature to the target blood vessel changes direction. The medical image is also evaluated to detect an intravascular device extending along the path. Thereafter, it is determined whether a particular portion of the intravascular device is positioned in the target region, and the curvature of the particular portion of the intravascular device is controlled as needed.

[0009]

[0009] A method for guiding a catheter through a blood vessel according to an embodiment of the present disclosure includes steering an intravascular device configured as a guide wire through the blood vessel to a target location, the intravascular device including a selectively bendable portion at the distal end of the intravascular device, and positioning the intravascular device at the target location, the target location including a location along the blood vessel. The method further includes orienting the distal end of the intravascular device by actuating the selectively bendable portion of the intravascular device to create a tip shape, and guiding the catheter through the blood vessel by advancing the catheter on the guide wire to the target location.

[0010]

[0010] Certain aspects of the present disclosure have other steps or elements in addition to, or in lieu of, those described above. These steps or elements will be apparent to those skilled in the art upon reading the following detailed description together with the accompanying drawings.

[0011] Brief Description of the Drawings / Figures

[0011] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate the present disclosure and, together with the specification, further explain the principles of the present disclosure and serve to enable those skilled in the relevant art to make and use the present disclosure.

Brief Description of the Drawings

[0012]

Figure 1

[0012] It is a perspective view of an intravascular device according to an embodiment.

Figure 1A

[0013] It is a perspective view of an intravascular device according to an embodiment.

Figure 2

[0014] It is a perspective view of the distal portion of an intravascular device according to an embodiment.

Figure 3

[0015] It is a partial cross-sectional view of the intravascular device of FIG. 2.

Figure 3A

[0016] Top and side views of an actuator of an intravascular device according to one embodiment.

Figure 3B

[0017] Partial cross-sectional view of an intravascular device according to one embodiment.

Figure 4

[0018] Cross-sectional view of the intravascular device of FIG. 2.

Figure 4A

[0019] Schematic cross-sectional view of an intravascular device according to one embodiment.

Figure 4B

[0020] Cross-sectional view of the intravascular device of FIG. 3B.

Figure 4C

[0021] Top and side views of an actuator of an intravascular device according to one embodiment.

Figure 5

[0022] Perspective view of the proximal portion of an intravascular device according to one embodiment.

Figure 6

[0023] Cross-sectional view of the intravascular device of FIG. 5.

Figure 7

[0024] Partial cross-sectional view of the proximal portion of an intravascular device according to one embodiment.

Figure 7A

[0025] Detailed view of a part of an intravascular device according to one embodiment.

Figure 8

[0026] Perspective view of an intravascular device according to one embodiment.

Figure 9

[0027] Partial cross-sectional view of the intravascular device of FIG. 8.

Figure 10

[0028] Cross-sectional view of the proximal portion of an intravascular device according to one embodiment.

Figure 11

[0029] Flowchart showing a method of using an intravascular device according to one embodiment.

Figure 12

[0030] Flowchart showing a method of using an intravascular device according to one embodiment.

DETAILED DESCRIPTION OF THE INVENTION

[0013]

[0031] In the drawings, the same reference numerals generally indicate the same or similar elements. Also, generally, the leftmost digit of a reference numeral indicates the drawing in which that reference numeral first appears.

[0014] Detailed Description

[0032] Hereinafter, representative embodiments illustrated in the accompanying drawings will be described in detail. References to "one embodiment", "an embodiment", "exemplary embodiments", etc. indicate that the embodiments described may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Further, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is understood within the knowledge of those skilled in the art that such feature, structure, or characteristic may affect other embodiments whether or not explicitly described.

[0015]

[0033] An intravascular device is used to perform an intravascular medical procedure and needs to be guided through a blood vessel to reach the treatment site. Since a typical intravascular device cannot actively bend to induce torsion or bending, this can be difficult in situations where the blood vessel in question includes multiple bends. Thus, one embodiment of the present disclosure is a tube having a selectively bendable portion, at least a portion of the tube being configured to be inserted into a blood vessel, and a control element configured to control the curvature of the selectively bendable portion to enable guidance of the tube through the blood vessel.

[0016]

[0034] The bendable nature of the intravascular device has several advantages, including an improved ability to navigate curved blood vessels and the ability to selectively and controllably change the shape of a portion of the intravascular device that may be beneficial during certain intravascular procedures. Further advantages will be described below.

[0017]

[0035] As shown in FIG. 1, the intravascular device 1 is formed as a generally tubular device. The intravascular device 1 includes a distal end 2 and a proximal end 3 (also referred to as "distal tip" and "proximal tip", respectively). The proximal end 3 generally remains outside the patient and is the end of a tube 100 that is operated by a user (e.g., a physician or other medical professional). The distal end 2 is generally the end of the tube 100 that is inserted into the patient's blood vessel. In some embodiments, the intravascular device 1 may have an overall length of 1500 to 2500 millimeters (mm). In some embodiments, the intravascular device 1 may have an overall length of about 2000 mm.

[0018]

[0036] The intravascular device 1 is formed from a tube 100. The tube 100 constitutes the body of the intravascular device 1. As seen in FIGS. 1 and 2, in some embodiments, the tube 100 can be formed as a cylinder having a central opening. The tube 100 can be formed from any suitable material well known in the art, such as metal or plastic, as will be described in detail below. Since the tube 100 is intended to be at least partially inserted into a blood vessel, the material of the tube 100 should be biocompatible. Examples of materials for the tube 100 (e.g., at least one of the entire body of the tube 100, or an intermediate tubular section including the distal end 2, the proximal end 3, or the non-bending portion 118 between the distal end 2 and the proximal end 3, and any combination thereof) include elastic polymers 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 rubbers, natural rubbers, thermoplastic elastomers, polyamides, polyimides, polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), acrylonitrile butadiene styrene (ABS), epoxies, polytetrafluoroethylene (PTFE), polyurethanes, thermoplastic polyurethanes (TPU), nylons, polyether block amides (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 particular embodiment, the tube 100 can be formed from stainless steel. According to some embodiments, the tube 100 is configured as monolithic, i.e., a single-piece element. In alternative embodiments, the tube 100 is configured to combine tubes of different materials (to be described in more detail below). In some embodiments, as will be described below, the tube 100 is configured to be elastically deformable along at least a portion of its length.

[0019]

[0037] In some embodiments, the tube 100 may have an outer diameter (OD) of from about 0.10 mm to about 1.10 mm. In some embodiments, the tube 100 may have an OD of from about 0.30 mm to about 0.90 mm. In certain embodiments, the tube 100 may have an OD of 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 can be formed as a cylinder with a central opening. According to some embodiments, the tube 100 may have an inner diameter (ID) of from about 0.10 mm to about 0.90 mm. In some embodiments, the tube 100 may have an ID of from about 0.20 mm to about 0.70 mm. In certain embodiments, the tube 100 may have an inner diameter of about 0.20 mm, about 0.30 mm, about 0.40 mm, about 0.50 mm, or about 0.60 mm.

[0020]

[0038] The intravascular device 1 includes at least one selectively bendable portion 110 (shown in a bent configuration in FIG. 1). As shown in FIG. 1, the bendable portion can be provided at the distal end 2, but the bendable portion can be provided at any other location along the tube 100, depending on the needs and circumstances. The bendable portion is controlled by an actuator control unit 200 at the proximal end 3, as will be detailed herein below. As will be detailed below, embodiments such as that shown in FIG. 1A can have a plurality of selectively bendable portions 110.

[0021]

[0039] The selectively bendable portion 110 is a portion of the tube 100 that can be controllably bent with respect to the original axis of the tube 100. As further described below, the selectively bendable portion 110 can be controlled by the user to improve the guidance of the intravascular device through the patient's blood vessel. In some embodiments, the selectively bendable portion 110 can extend axially along the tube 100 from about 5 mm to about 50 mm. In some embodiments, the selectively bendable portion 110 can extend axially along the tube 100 from about 10 mm to about 30 mm. In certain embodiments, the selectively bendable portion 110 can extend axially along the tube 100 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.

[0022]

[0040] The actuator control unit 200 is a control element that enables the user to achieve control of the selectively bendable portion 110. The actuator control unit 200 includes a handle 210 and a grip 212 for controlling the curvature of the selectively bendable portion 110.

[0023]

[0041] The grip 212 is configured to enable the user to grasp the intravascular device 100. When the user moves the grip 212 linearly with respect to the patient, the intravascular device 100 can move deeper or shallower within the patient's blood vessel. When the user moves the grip 212 in a twisting motion, the tube 100 can rotate within the patient's blood vessel, effectively rotating the orientation of the selectively bendable portion 110.

[0024]

[0042] The user can bend the selectively bendable portion 110 by, for example, changing the relative distance between the handle 210 and the grip 212. The interventional radiologist can, for example, hold the handle 210 with one hand and the grip 212 with the other hand. By increasing the relative distance, the selectively bendable portion 110 bends more, for example, the radius of curvature becomes shorter. Also, by decreasing the relative distance, the selectively bendable portion 110 becomes less curved until the selectively bendable portion 110 becomes a straight tube 100 extending linearly, for example, the radius of curvature becomes longer. In this way, a user such as an interventional radiologist can adjust the selectively bendable portion 110 according to the predicted state of the patient's vascular path. How this curvature control can be achieved will be described below with respect to FIGS. 5-8.

[0025]

[0043] For example, when an artery or vein branches in two directions, the user can move the handle 210 relative to the grip 212 to create a desired curvature. The user can then rotate the grip 212 to direct the curvature of the selectively bendable portion 110 toward the desired branch, and move the grip 212 linearly to move the distal end 2 of the intravascular device 1 to the desired branch. In this way, the user can guide the distal end 2 of the intravascular device 1 to a desired position within the patient's vascular system.

[0026]

[0044] In some embodiments, as seen in FIGS. 2-3, an opening 102 is formed in the tube 100. As described above, the tube 100 can be made of any suitable material including medical grade stainless steel. The opening 102 is a portion removed from the material (e.g., a notch). In some embodiments, these openings 102 are formed as slots in the tube 100 that at least partially penetrate from the outside to the inside of the tube 100 around the circumference of the tube 100. In some embodiments, the opening 102 penetrates from the outside 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 opening 102. As shown in FIG. 2, the opening 102 does not extend entirely around the tube 100. The opening 102 can extend, for example, from 10 percent to 90 percent around the circumference of the tube 100.

[0027]

[0045] In some embodiments, the opening 102 can be formed as a regular rectangular shape projected onto the surface of the tube 100 (as shown in FIG. 2). In these embodiments, for example, the opening 102 can have an axial width of from about 0.01 mm to about 0.1 mm. According to certain embodiments, the opening 102 can have an axial width of from about 0.02 mm to about 0.06 mm. The opening 102 can also be formed from different shapes projected onto the surface of the tube 100, such as a slit, circular, oval, triangular, or any other desired polygon. The opening 102 may be etched from the tube 100 using any manufacturing method well known in the art, such as, for example, using a disk, cutting or grinding with a semiconductor dicing blade, or the use of laser cutting.

[0028]

[0046] By removing material from the tube 100, the opening 102 reduces the rigidity or flexural resistance of the tube 100. Thus, the opening 102 can be used to create a more flexible or bendable portion of the tube 100. These are portions of the tube 100 that are more controllably bendable, as described below. Thus, the flexibility of the tube 100 can be controlled by varying the extent of the opening 102. For example, increasing the extent by increasing the size, number, shape, or density of the opening 102 causes the rigidity of the tube 100 to decrease or the tendency to bend to increase. Conversely, decreasing the extent by decreasing the size, number, shape, or density of the opening 102 causes the rigidity of the tube 100 to increase or the tendency to bend to decrease. Thus, as shown in FIG. 1, the selectively bendable portion 110 of the tube 100 has the opening 102, while the second portion of the tube 100 does not have the opening 102. Further, the tube 100 may include a third portion (e.g., a non-bendable portion 118 as further described below) that includes openings 102 with reduced size, number, or density compared to the selectively bendable portion 110. The third portion of the tube 100 may be provided anywhere along the tube, such as between the selectively bendable portion 110 and the second portion of the tube 100, and provides some flexibility to the tube at any desired location depending on the needs and circumstances of the device.

[0029]

[0047] It should be noted that the tube 100 can be bent to some extent even if there is no opening 102 at all. However, the addition of the opening 102 enables the creation of the target selectively bendable portion 110. In some embodiments, as shown in FIG. 2, the openings 102 have the same dimensions but different intervals therebetween. For example, the openings 102 disposed in the selectively bendable portion 110 may have an interval of 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 particular embodiment, the openings 102 disposed in the selectively bendable portion 110 may have an interval of about 0.08 mm to about 0.06 mm (e.g., a pitch of about 0.12 mm to about 0.16 mm). The openings 102 in a separate more proximal portion of the tube 100 (such as the third portion described above) may be smaller and more spaced apart, and may have an interval of about 0.03 mm to about 3 mm (e.g., a pitch of about 0.06 mm to about 3 mm).

[0030]

[0048] Another example of varying the scope of the openings 102 is a change in the spacing between the openings 102. The greater the spacing between the openings 102, the greater the rigidity of the tube 100, and the smaller the spacing between the openings 102, the lower the rigidity of the tube 100. This technique can be used to create various stiffness gradients and adjust the stiffness of the tube 100 as desired. For example, in some embodiments, the spacing or pitch of the openings 102 of the selectively bendable portion 110 is smaller at the end of the selectively bendable portion 110 closest to the distal end 2. In these embodiments, the spacing increases towards the end of the selectively bendable portion 110 closer to the proximal end 3. In this way, the selectively bendable portion 110 is biased to be more flexible the closer it is to the distal end 2, which is the end that is first inserted into the blood vessel. The rate of change of the spacing can be made constant or variable to adjust the change in stiffness 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 be desirable to 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 intended to remain outside the patient during an intravascular procedure.

[0031]

[0049] In some embodiments, the design or material of the tube 100 can also be used to adjust the flexibility of the tube 100. For example, the cross-sectional dimensions or shape of the tube 100 may be changed to increase or decrease flexibility. Changing the material of the tube 100 can also vary the flexibility. For example, as shown in FIG. 4A, two or more portions of the tube 100 may be made of different materials, which can be used to change the flexibility. For example, the greater the rigidity of the material, the lower the flexibility of the corresponding portion of the tube 100. This can be useful when a change in flexibility is desired without changing the outer dimensions of the tube 100. These different materials can be joined to each other at the connection portion 103. The connection portion 103 can be any suitable connection technique, including but not limited to the use of adhesives, welding, or mechanical connectors such as rings or sleeves (used alone or in combination with other connection techniques).

[0032]

[0050] As shown in FIGS. 1 - 3, in some embodiments, there is a single selectively bendable portion 110 disposed at the distal end 2 of the tube 100. This allows the portion of the tube 100 at the distal end 2 to be more flexible and thus selectively bendable. The selectively bendable portion 110 may also be disposed at various other locations along the tube 100 as needed to increase flexibility and control. Thus, the selectively bendable portion 110 may be disposed at the distal portion of the intravascular device 1 that is not the distal end 2, such as up to about 150 mm from the distal end 2. As shown in FIGS. 2 - 3, in some embodiments, this distally - located selectively bendable portion 110 is terminated at the distal end 2 by a plug 112. The plug 112 functions to terminate or seal the distal end 2. The plug 112 is typically a non - sharp, rounded, elliptical, or similar - shaped, atraumatic tip in order to generally improve the ability of the tube 100 to pass through the blood vessel without damage. A washer 114 is disposed between the selectively bendable portion 110 and the plug 112. The plug 112 and the washer 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. Both the plug 112 and the washer 114 can be made from any suitable biocompatible material including metals, metal alloys / oxides, adhesives, silicones, and plastics, or any combination thereof. Materials opaque to X - rays, such as platinum, gold, tungsten, tantalum, etc., may be incorporated into the plug or washer in order to function as an X - ray fluoroscopy marker to assist visualization during intravascular device guidance.

[0033]

[0051] In some embodiments, the selectively bendable portion 110 is the only portion of the tube 100 that can be controllably actuated or bent. Thus, there may be one or more non-bendable portions 118 disposed throughout the tube 100. These non-bendable portions 118 can be disposed directly adjacent to the selectively bendable portion 110 or spaced apart from the selectively bendable portion 110. It should be noted that the non-bendable portions 118 may still have some ability to passively bend and flex, depending on the rigidity of the tube 100 at the non-bendable portions 118, and often do. The method of adjusting this rigidity will be described below.

[0034]

[0052] As can be seen in FIGS. 3-4, for example, the intravascular device 1 can include a control element 120 (also referred to as an actuator) disposed within the tube 100. The control element 120 can take the form of any suitable rigid element that can slide freely within the tube 100. The control element 120 needs to have sufficient rigidity to prevent it from buckling excessively when compressed (while straightening the selectively bendable portion 110). However, the control element 120 must also have sufficient flexibility so as not to overly reduce the flexibility of the tube 100. The rigidity of the control element 120 also affects the flexibility of the selectively bendable portion 110, and thus the portion of the control element 120 that travels through the selectively bendable portion 110 must be designed to allow the selectively bendable portion 110 to bend as desired. The control element 120 can 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 can be a solid wire, a multifilament wire, a string, or a thread. For example, the control element 120 can be a solid wire formed from any material well known in the art such as, but not limited to, a nitinol alloy, stainless steel, and plastic materials, or any combination thereof. For example, as shown in FIGS. 1-4, the control element 120 can be formed as a solid wire sized to fit within the tube 100. The control element 120 can also take the form of a tube, as will be described below.

[0035]

[0053] The function of the control element 120 is to transmit a force for selectively bending or straightening the selectively bendable portion 110. This is accomplished by fixing 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 fixed to a washer 114, which is then fixed to the end of the selectively bendable portion 110. Since the selectively bendable portion 110 can be installed anywhere along the tube 100, the washer 114 can be located at different locations along the tube 100 depending on where the selectively bendable portion 110 begins and ends. As seen in FIGS. 3, 3B, and 4A, in one embodiment, the control element 120 passes through the opening of the washer 114 and curves to fit into the groove 115 of the washer 114. For example, as shown in FIGS. 3 and 3B, the control element 120 extends through the axially moving washer 114 and then curves back approximately 180 degrees to fit into the groove 115, forming a U-shaped curve. In this way, the control element 120 is fixed to the washer 114 in both the axial and rotational directions at the distal end 2 of the intravascular device 1. Examples of these types of curves are shown in both FIGS. 3, 3B and 4A. In addition to passing through the washer 114 as described, the control element 120 may also be fixed by mechanical means such as adhesives and friction fits or by forming additional bends / angles in the control element 120. This method of connecting the control element 120 to the washer 114 also improves the connection between the tube 100 and the control element 120 because the washer 114 significantly reduces the possibility of the control element 120 separating from its fixed position relative to the tube 100.

[0036]

[0054] Otherwise, the control element 120 can slide freely within the tube 100 to transmit force from the actuator control unit 200 to the washer 114 at the distal end 2. When the control element 120 retracts relative to the tube 100 towards the proximal end 3 from the straight position shown in FIG. 2, the selectively bendable portion 110 bends to adapt to the shortened length of the control element 120 (as seen in FIG. 1). Conversely, when the control element 120 extends towards the distal end 2, the selectively bendable portion 110 straightens. More specifically, in one embodiment, the movement of the handle 210 in the proximal direction can increase the tension applied to the control element 120 and cause the selectively bendable portion 110 to curve, and the movement of the handle 210 in the distal direction can decrease the tension applied to the control element 120 and cause the selectively bendable portion 110 to straighten.

[0037]

[0055] In some embodiments, the control element 120 can be configured to increase the tendency of the selectively bendable portion 110 to bend in one or more desired directions. This is achieved by changing the shape of the control element 120 to increase its tendency to bend in one or more given directions. Thus, the control element 120 can have any cross-section (perpendicular to the longitudinal axis), such as circular, oval, square, rectangular, etc.

[0038]

[0056] For example, in the embodiment as shown in FIG. 4, the control element 120 is formed from a solid wire having different cross-sections. Near the proximal end 3, this embodiment of the control element 120 has a circular cross-section. As the control element 120 continues in the distal direction, as seen in FIG. 4, the control element 120 flattens and has a rectangular cross-section. The rectangular cross-section has a tendency to bend in a direction perpendicular to the long side of the rectangle, creating a preferred or biased bending direction for the selectively bendable portion 110 within which the control element 120 is disposed.

[0039]

[0057] Additionally or alternatively, the control element 120 can maintain the same cross-section but vary in size to change the tendency to bend. For example, the control element 120 may maintain a circular cross-section, but the diameter can be increased or decreased to increase or decrease rigidity, respectively. This type of control element 120 does not have a biased bending direction since the cross-sectional shape is maintained. Instead, it has a smaller or larger tendency to bend depending on the dimensions of the control element 120. The dimensions of these varying regions of the control element 120 can be varied to achieve the desired bending resistance when combined with the characteristics of the tube 100. For example, one embodiment of this type of control element 120 can have a first diameter, a second diameter, and a third diameter that are different at different locations along the length of the control element 120.

[0040]

[0058] For example, one embodiment of the control element 120 is shown in FIG. 3A, which shows a side view and a top view of the control element 120. In this embodiment, the control element 120 has a constant diameter portion 120a, a tapered portion 120b, and a flattened portion 120c. The constant diameter portion 120a has a cross-section of a predetermined diameter that may correspond to the portion of the control element 120 that is close to the proximal end 3 of the tube 100 when assembled to the intravascular device 1. The tapered portion 120b has a diameter that always decreases as the distance from the constant diameter portion 120a increases. The flattened portion 120c has a rectangular cross-section whose width increases as the distance from the tapered portion 120b increases (and is thus flattened compared to other portions of the control element 120). The flattened portion 120c may correspond to the selectively bendable portion 110 and thus may correspond to the distal end 2 of the tube 100. Those skilled in the art will understand that as the distance from the constant diameter portion 120a increases, the flexibility of the control element 120 increases in all bending directions of the tapered portion 120b due to the decreasing diameter. The bending of the flattened portion 120c is biased towards bending in the in-out direction of the drawing with respect to the top view due to the flattened cross-sectional shape. This embodiment of the control element 120 is shown in the tube 100 of FIG. 3B, and the cross-section of FIG. 3B is shown in FIG. 4B.

[0041]

[0059] In some embodiments, the constant diameter portion 120a has a diameter in the range of about 0.1 to about 0.45, for example, about 0.140 to about 0.180 mm. At its proximal end, the tapered portion 120b 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 may be uniformly distributed (linear taper) along the axial length of the tapered portion 120b, or can be non-uniformly distributed. The flattening portion 120c may begin at the minimum diameter of the tapered portion 120b and have a width dimension that increases to the diameter of the constant diameter portion 120a. As seen in FIG. 3A, there can be four steps of increasing width, the first (proximal) step being in the range of about 0.100 mm to about 0.170 mm, the second step being in the range of about 0.110 mm to about 0.180 mm, the third step being in the range of about 0.120 mm to about 0.190 mm, and the fourth step being about 0.130 mm to about 0.200 mm. Here, the width dimension is defined as the dimension in the downward direction from the top of FIG. 3A with respect to the upper and lower surface views. It should be understood that more or fewer steps of the flattening portion 120c can be present as necessary or desired to adjust flexibility. The flattening portion 120c can also be flattened and expanded gradually and non-stepwise in width, as shown in FIG. 4C.

[0042]

[0060] The biased flexion as described above can also be achieved by non-uniformly distributing the opening region created by the opening 102 around the tube 100. For example, by making the opening 102 larger on one side of the tube 100, the tube 100 is biased to flex in the direction of that side. Biasing the flexion of the tube 100 using any combination of these methods has the advantage of providing a predictable flexion to the user of the intravascular device 1. This is particularly useful when the distal end 2 of the tube 100 is inserted into a blood vessel and is not visible. The orientation of the remaining portion of the tube 100 (present outside the blood vessel) allows the user to understand the direction in which the distal end of the tube 100 flexes with respect to the blood vessel due to such bias.

[0043]

[0061] 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 a biased bending region achieved by having an asymmetric distribution of the openings 102 as described above.

[0044]

[0062] The same tube 100 having an asymmetric distribution of the openings 102 in one or more selectively bendable portions of the tube 100 can also have a set of symmetric openings disposed in different portions of the tube 100. These symmetric openings 100 improve the flexibility of the tube 100 without introducing any directional bias. Finally, the same tube 100 may have a portion where there are no openings 102, for example, a portion of the tube 100 intended to remain outside the patient during the procedure.

[0045]

[0063] For example, in some embodiments, there may be a selectively bendable portion 110 having an asymmetric opening as described above, disposed at the distal end 2. Moving proximally from the selectively bendable portion 110, there is a non-bendable portion 118 having symmetrically disposed openings 102 around the tube 100 to increase the flexibility of the tube 100. In this embodiment, the openings 102 of the non-bendable portion 118 have an axially increasing spacing or pitch as the non-bendable portion 118 progresses axially towards the proximal end 3. This has the effect of gradually increasing the rigidity of the tube 100 in the proximal direction. Finally, the portion of the tube 100 proximal to the non-bendable portion 118 does not have openings 102. These features provide a soft, flexible, and controllable distal section of the intravascular device that is optimal for guidance in tortuous anatomical structures, while providing support, shape retention, optimal torque transmission, and regulated pushability in the more proximal sections.

[0046]

[0064] The movement of the control element 120 within the tube 100 can 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.

[0047]

[0065] As can be seen in FIGS. 3 and 4, the spacer 130 can be disposed between the control element 120 and the inside of the tube 100. The spacer 130 serves as a spacer and guide that confines the movement of the control element 120 within the tube 100. In these embodiments, and as described in the following paragraphs, the spacer 130 is described as a solid material. However, the spacer 130 may include a liquid lubricating element or may be only liquid lubrication. For example, oil can be added to the interior of the tube 100 (e.g., in the vicinity of 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.

[0048]

[0066] The spacer 130 is fixed to the inside of the tube 100. Suitable means for fixing the spacer 130 to the tube 100 include, but are not limited to, welding, soldering, brazing, use of adhesives, and mechanical connections. In some embodiments, the connector 132 fixes the spacer 130 to the tube 100. In other embodiments, the spacer 130 can be fixed to the washer 114 using any method well known in the art, such as using an adhesive, which in turn means that the spacer 130 is fixed to the tube 100 since the washer 114 is fixed to the tube 100. According to one embodiment, the spacer 130 can completely surround the control element 120 circumferentially. Alternatively, the spacer 130 can only partially surround the control element 120 circumferentially. In some embodiments, the spacer 130 extends along the entire length of the tube 100. In other embodiments, the spacer 130 extends only a part of the axial length of the tube 100. In other embodiments, the spacer 130 extends to a part of the selectively bendable portion of the tube 100.

[0049]

[0067] In some embodiments, the spacer 130 can be formed as a continuous tube of material. In other embodiments, the spacer 130 can be formed from a strip or wire wound in a spiral or coil within the tube 100. In other embodiments, the spacer 130 can be formed from several material strips or wires wound in a spiral or coil within the tube 100. Other possible forms of the spacer 130 include discrete material strips extending along the length of the tube 100, or discrete material rings separated from each other. The spacer 130 can be formed from a biocompatible material that allows the control element 120 to slide relative to the spacer 130. For example, without limitation, the spacer 130 can be made from metals, metal alloys / oxides, silicones, and plastic materials, or any combination thereof. Exemplary materials for the spacer 130 include nitinol, platinum, iridium, polytetrafluoroethylene (PTFE), and fluoropolymers such as polytetrafluoroethylene.

[0050]

[0068] In some embodiments, the material selected for the spacer 130 is radiopaque, which means that the spacer 130 is visible on an x-ray scan or similar type of medical image when it is implanted in the body. This can be achieved by the selection of the material or by the addition of additives or coatings to the spacer 130. For example, materials such as gold, platinum, tungsten, tantalum, etc. may be incorporated into the spacer 130 to function as an x-ray fluoroscopy marker to assist visualization. According to one embodiment, the spacer 130 is at least partially formed from a material selected from the group consisting of metal alloys and fluoropolymer materials to ensure that the spacer 130 is sufficiently radiopaque. In other embodiments, the tube 100 can be made radiopaque by either the selection of the material (as described above) or the addition of additives or coatings (described below).

[0051]

[0069] As shown in FIGS. 5 to 7, the actuator control unit 200 is disposed at the proximal end 3 of the tube 100. As described above, the actuator control unit 200 enables the user to move the control element 120 with respect to the tube 100. This portion of the tube 100 and the actuator control unit 200 is generally intended to remain outside the patient's blood vessel and body.

[0052]

[0070] In an embodiment, the actuator control unit 200 is formed from a tubular handle 210 disposed around the proximal end 3 of the tube 100. The handle 210 is configured to slide around the outside 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 one embodiment, the handle 210 may extend beyond the proximal end 3 of the tube 100.

[0053]

[0071] The control element 120 exits the proximal end 3 of the tube 100, enters the center of the handle 210, and is fixedly connected to the inside 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. Thus, in some embodiments, the control element 120 extends through the entire length of the tube and is connected to the proximal end 3 of the tube 100. For example, as shown in FIG. 6, the control element 120 may extend to and be fixed to a plug 218 that closes the end of the handle 210. In this way, movement of the handle 210 relative to the tube 100 causes the control element 120 to move, which in turn causes the selectively bendable portion 110 to bend.

[0054]

[0072] As described above, the grip 212 is located distally relative to the handle 210 and is disposed around the outside of the tube 100. The grip 212 is fixed to the outside of the tube 100 and is configured to function as a placement location for the user's hand to better control the movement of the handle 210. Both the grip 212 and the handle 210 can be formed to have a comfortable and non-slip gripping surface suitable for being gripped by hand. The handle 210 may be formed from a composite structure, where the portion of the handle 210 adjacent to the tube 100 is formed from a material suitable for sliding relative to the tube 100, such as rigid plastic, while the portion facing the outside of the handle 210 can be formed from rubber or a foamed material to improve the grip by the user.

[0055]

[0073] The stopper 216 may be included as part of the actuator control unit 200. The stopper 216 functions to prevent the handle 210 from advancing too far distally along the tube 100. As seen in FIG. 6, in some embodiments, the stopper 216 is a protrusion fixed to the tube 100. This protrusion extends a predetermined distance inside the handle 210. Suitable means for fixing the stopper 216 to the tube 100 include, but are not limited to, welding, soldering, brazing, use of adhesives, and mechanical connection. The friction element 140 contacts the stopper 216 and prevents the handle 210 from advancing too far, because the friction element 140 is fixed to the control element 120, and the control element 120 is further fixed to the handle 210 (via the plug 218). Other embodiments of the stopper 216 can include structures such as protrusions or rings fixed inside the handle 210 configured to perform the same function.

[0056]

[0074] As shown in FIG. 5, one or more markings 214 may be disposed on the outer side of the tube 100 such that a user can determine the degree of bending through alignment of the handle 210 with the markings 214. The markings 214 can include a neutral marking corresponding to the straight position of the selectively bendable portion 110.

[0057]

[0075] The key structure 150 may be formed within the tube 100 to ensure that the rotational torque of the control element 120 is transmitted to the tube 100. For example, a user may turn the handle 210 relative to the axis of the tube 100, thereby further applying rotational torque to the control element 120. The key structure 150 ensures that this torque, which has the effect of rotating the tube 100 in response to the torque applied by the user, is transmitted to the tube 100. For example, FIG. 7A shows one embodiment of the key structure 150 installed inside the tube 100 and including a material fixed to the tube 100. The opening of the key structure 150 may 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 rotation of the control element 120 relative to the tube 100. For example, the control element 120 may be flattened to a rectangular cross-section at the narrow portion 151. It will be understood that any suitable shape may be used to prevent rotation of the control element 120. The material of the key structure 150 may be any suitable material well known in the art, including but not limited to metals, plastics (such as polyetheretherketone (PEEK)), and composite materials. The key structure 150 may be fixed to the tube 100 using any suitable process, including but not limited to adhesives, welding, soldering, and brazing.

[0058]

[0076] As shown in FIG. 6, the friction element 140 can be disposed within the tube 100. The friction element 140 functions to increase the sliding friction that affects the control element 120. This has at least two advantages. First, it enables adjusting the feel of moving the control element 120 to a desired value. This is important because a friction level that is too low can result in unintentional movement of the control element 120, and a friction level that is too high can make it difficult to precisely use the control element 120. In some embodiments, the desired friction level is about 0.5 to 2.0 Newtons, 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 stay in a given position once set. This is important because problems can occur, such as the intravascular device 1 moving from a given position, due to unwanted movement of the control element 120 caused by the movement of the intravascular device 1 through a blood vessel, for example when moving a catheter (e.g., a suction catheter) on a guide wire to reach a target location.

[0059]

[0077] As shown in FIG. 6, in some embodiments, the friction element 140 is formed from a tubular sleeve 142 installed around the control element 120 within the tube 100. The tubular sleeve 142 is fixed to the control element 120, for example, by an adhesive, welding, friction fitting, or press fitting. The tubular sleeve 142 is sufficiently rigid to be formed into different shapes. According to one embodiment, as shown in FIG. 6, the tubular sleeve 142 can form several bends such that there are several discrete contact points 144 between the tubular sleeve 142 and the inside of the spacer 130 (or, in some embodiments, the inside of the tube 100). These contact points 144 create friction when the control element 120 moves.

[0060]

[0078] The resulting friction can be adjusted by varying the total number of contact points 144, the contact surface area at each contact point 144, and the pressure exerted between the contact points 144 and the inside of the spacer 130. For example, adding additional bends to the tubular sleeve 142 results in more contact points 144, thereby increasing the friction. Increasing the angle of each bend increases the surface area of the contact points 144 and also increases the friction.

[0061]

[0079] The friction element 140 can be installed anywhere within the tube 100, although it may be desirable to install the friction element 140 in the portion of the tube 100 (near the proximal end 3) that is intended to remain outside the body. This prevents the rigidity of the friction element 140 from affecting how the tube 100 bends within the body.

[0062]

[0080] As seen in FIG. 7, other embodiments of the friction element 140 can adjust the friction between the handle 210 and the outside of the tube 100. In FIG. 7, a pair of tubes are fixed from the friction element 140 to the inside of the handle 210. These tubes slide along the outside of the tube 100 to set the friction to a desired level. Other embodiments of the friction element 140 can include structures such as separate rings or washers that are fixed to the control element 120 and contact the inner surface of the spacer 130. Adjustment of the frictional force can be achieved in a manner similar to that described above by increasing the number or size of the contact points between the ring / washer and the spacer 130. Other embodiments of the friction element 140 can include structures such as rings, sleeves, or tubes that are fixed inside the spacer 130 through which the control element 120 passes. In some embodiments, these structures can be incorporated into the spacer 130, for example, as a narrow section of the spacer 130 that applies friction to the control element 120.

[0063]

[0081] As shown in FIGS. 1A and 8-10, 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. By adding more selectively bendable portions 110, more controlled directivity is added to the tube 100, so that the ability of the intravascular device 1 to guide blood vessels can be improved. In some embodiments, as shown in FIG. 8, one selectively bendable portion 110 as described above is disposed at the distal end 2. 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-bendable portion 118 of the tube 100. In some embodiments, the separation distance is about 5 mm to about 100 mm in the axial direction. According to some embodiments, the separation distance is about 10 mm to about 50 mm in the axial direction. According to a particular embodiment, the separation distance is about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm or about 30 mm in the axial direction. The above description regarding the bending bias of the tube 100 applies equally to the plurality of selectively bendable portions 110. For example, each selectively bendable portion 110 can be biased in a particular radial direction, which may or may not be in the same direction as any other selectively bendable portion 110, using the techniques described above.

[0064]

[0082] Each selectively bendable portion 110 includes a unique control element 120 that moves through the tube 100 and is fixed to the distal end of the selectively bendable portion 110. Further, each of the selectively bendable portions 110 may have a spacer 130, a friction element 140, and an actuator control unit 200 disposed at the proximal end 3 as shown in FIG. 10. This allows for completely independent control of each selectively bendable portion 110. In some embodiments, there is a single grip 212 that is shared between separate actuator control units 200. In other embodiments, there are two grips 212 that each operate with one of two actuator control units 200.

[0065]

[0083] In the exemplary embodiments shown in FIGS. 1A and 8 - 10, the control element 120 corresponding to the distally selectively bendable portion 110 is a wire (e.g., a solid wire having different cross - sections as described in detail hereinabove). The wire - type control element 120 is fixed to the more distally selectively bendable portion 110 using the methods described above. Further, a spacer 130 can be disposed between the wire - type control element 120 and the tube 100, and such a spacer can also be fixed to the tube 100 using the methods described above. The control element 120 corresponding to the more proximally selectively bendable portion 110 is a tube (also referred to as the "second tube") disposed between the wire - type control element 120 and the tube 100. A proximal spacer 130 can also be used between the tube - type control element 120 and the tube 100. This configuration results in a symmetric distribution of the actuator 120 and reduces the influence on the bending of the tube 100. The tube - type control element 120 is fixed to the more proximally selectively bendable portion 110 using the methods described above. Further, the proximal spacer 130 is fixed to the more proximally selectively bendable portion 110 using the methods described above. However, a washer 114 associated with the more proximally selectively bendable portion 110 is not necessarily present.

[0066]

[0084] In embodiments where each control element 120 is formed as a wire, each control element 120 is disposed through the center of the tube 100 and then fixed to its respective selectively bendable portion 110 using the methods described above. As described above, in some embodiments, it is desirable to fix the control element 120 to the most distal end of the selectively bendable portion 110, but different attachment points are possible. In these embodiments, each control element 120 can have its own spacer 130 or can use a single spacer 130 as described above.

[0067]

[0085] The actuator control unit 200 of a device including two or more selectively bendable portions 110 functions in the same manner as the single selectively bendable portion 110 described above. However, as seen in FIG. 10, the handles 210 of each actuator control unit 200 are staggered along the tube 100 so that they can be actuated independently. For example, the handle 210 associated with the proximally located selectively bendable portion 110 can be positioned more 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 handle 210 associated with the proximally located selectively bendable portion 110 can be arranged as described above. Both handles 210 can have markings 214 configured as described above and can each have a stopper 216 that functions as a movement stop as described above.

[0068]

[0086] In some embodiments, at least some of the tubes 100 may be coated with various substances to improve system performance. For example, depending on the needs and circumstances, the outer surface of the tube 100 intended to be inserted into a patient may be wholly or partially provided with an elastic or otherwise conformable, biocompatible coating or sheath to impart hydrophobic or hydrophilic properties to the smooth outer surface. The coating material is selected to minimize the sliding friction of the device during insertion and removal into the subject's body and is substantially chemically inert in the in-vivo vascular environment. According to one embodiment, the outer surface of the tube 100 may have a hydrophilic coating to reduce the friction between the tube 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 the coating. Additionally or alternatively, the coating material may be selected for its hydrophilic properties, thus improving the sliding and maneuverability in the blood. Typically, this type of coating is applied to the distal end 2 of the tube 100 and extends up to 50 cm from the tip. Suitable coatings can be formed by any method known in the art, such as dipping, spraying, or wrapping, and heat curing operations.

[0069]

[0087] Other coating options include agents that can be delivered into the patient's body during operation of the intravascular device 1. Such drugs can be used for the treatment of the patient, to assist in the effectiveness of the treatment, or to avoid complications that may arise as a result of the treatment. For example, this type of coating can include anti-restenosis drugs (including drugs that inhibit coagulation, such as anticoagulants, antithrombotic drugs, and antiplatelet drugs such as clopidogrel and heparin), anti-inflammatory drugs, immunosuppressive drugs, antibiotics, antihyperlipidemic drugs, antiproliferative drugs, and endothelium-promoting drugs. Examples of a detailed list of these types of coatings can be found in Tables 8 and 12 of Rykowska I. et al., Molecules (2020) 25:4624; doi:10.3390 / molecules25204624, which is incorporated herein by reference.

[0070]

[0088] 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), and 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 well known in the art as described above.

[0071]

[0089] As shown in FIG. 11, the method of guiding the catheter begins at step 1102 when the distal end 2 of the intravascular device 1 is inserted into the blood vessel by a user such as a physician or other medical professional performing a medical procedure. In some embodiments, the blood vessel may be spatially distant from the target location. For example, the blood vessel may be located in the patient's thigh or the patient's wrist, and the target location may be located in the patient's head, neck, stomach, chest, or peripheral organ. The target location may be any location within the body that requires a medical procedure to be performed with the assistance of the intravascular device 1. For example, the target location may be a location including a blood clot, stenosis, constricted blood vessel (e.g., vasoconstriction), or aneurysm.

[0072]

[0090] Next, at step 1104, the intravascular device 1 is advanced or steered through the blood vessel (or blood vessels) until it is positioned at the target location. This is achieved, for example, by the user operating the actuator control unit 200 to advance the intravascular device 1. The selectively bendable portion 110 is controlled via the actuator control unit 200 (which remains outside the patient's body) as needed to guide the intravascular device 1 through the various curves present within the blood vessel.

[0073]

[0091] When the distal end 2 reaches the target location, in step 1106, the selectively bendable portion 110 located at the distal end 2 can be actuated to control the curvature of the tip and create a tip shape that orients the tip as needed. Additionally or alternatively, the selectively bendable portion 110 located at the distal end 2 can be actuated to provide shape retention to increase support and / or to orient the distal end of the intravascular device. For example, the tip shape can be oriented to be aligned or aimed at the target location. In some embodiments, this tip shape can be a bent shape, or a non-straight shape, a J-shape, or a cobra shape. This orientation of the tip shape does not require additional support to maintain its orientation. For example, support from blood vessels, additional guidewires, additional catheters, or additional intravascular devices is not required.

[0074]

[0092] In some embodiments, the intravascular device 1 is configured to function as a guidewire that can be used to guide a catheter through a blood vessel to a target location. Thus, in step 1108, the catheter can be advanced through the blood vessel to perform a related medical procedure at the target location. For example, the catheter can be a suction catheter, and the target location can be a blood clot or adjacent to a blood clot. When the target location is reached, the suction catheter can be used to remove the blood clot by suction or other appropriate procedures. These embodiments of the intravascular device 1 can also be used to guide other medical devices, such as additional guidewires, different types of catheters, or any other appropriate system, to a target location accessible through the blood vessels in the body. For example, the additional device can be a stent retriever, and the stent retriever can be used to retrieve a blood clot from a blood vessel by applying the stent retriever through a microcatheter. According to another example, the catheter can be a microcatheter, and the target location can be a blood clot, an aneurysm, or a location of a narrowed blood vessel such as vascular stenosis or stricture.

[0075]

[0093] As shown in FIG. 12, a further method of guiding the intravascular device 1 through the vasculature begins in step 1202 of receiving a medical image taken during an intravascular procedure. This medical image can be taken by any suitable medical imaging technique such as, but not limited to, X-ray, CT, or MRI. The image can be stored in a suitable computer or other device.

[0076]

[0094] In step 1204, the medical image is analyzed to detect a target region where the path of the vasculature to the target vessel changes direction. For example, this can include a curve or twist in the vessel that requires additional steps to successfully guide the intravascular device 1. This can be achieved, for example, by visual inspection of the image or by a suitable algorithm executed by a computer. For example, this can be achieved by a computer vision model trained to recognize blood vessels.

[0077]

[0095] In step 1206, the medical image is further analyzed to detect the intravascular device 1 extending through the target vessel. This can be achieved, for example, by visual inspection of the image or by a suitable algorithm executed by a computer. This step can be facilitated by the radiopacity of one or more elements of the intravascular device 1 as described above. For example, this can be achieved by a computer vision model trained to recognize radiopaque elements.

[0078]

[0096] Once both the target region and the intravascular device 1 are located, in step 1208, a determination is made as to whether a particular portion of the intravascular device is positioned in the target region. This can be achieved using a similar approach as described for steps 1206 and 1208.

[0079]

[0097] If that is the case, in step 1210, the curvature of a specific portion of the intravascular device 1 is controlled to guide it to the target area. This can be achieved by changing the curvature of the selectively bendable portion 110 as described 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 migrate beyond the target area.

[0080]

[0098] In some embodiments, the intravascular device 1 is configured as a guidewire for guiding a suitable medical device, such as a suction catheter, to the target area. In other embodiments, the intravascular device 1 itself is configured as, for example, a catheter (e.g., as a guiding catheter).

[0081]

[0099] After an action such as a medical procedure is completed, a second medical image can be taken to ensure the success of the procedure. Additionally, or alternatively, the completion of the operation can be determined using the signals received from the sensor 108 disposed on the intravascular device 1. The sensor 108 can be any suitable sensor and can function, for example, to detect the presence of a thrombus, the type of thrombus, or the type of stenosis present in the blood vessel. After the action is completed, the curvature of the intravascular device can be controlled to reverse or modify the initial curvature control process. This enables the removal of the intravascular device 1.

[0082]

[0100] In embodiments of the intravascular device 1 having a plurality of selectively bendable portions 110, the first process described above regarding controlling the curvature of a specific portion can be performed for each selectively bendable portion 110 using an appropriate image.

[0083]

[0101] These steps can also be performed on a suitable computing device having a memory and a processor. In particular, the evaluation of the image and the determination of the relative position of the intravascular device 1 and the target region can be performed by a suitable algorithm stored in the memory and executed by the processor.

[0084]

[0102] Further exemplary embodiments of the present invention are provided below.

[0085]

[0103] Example 1

[0104] A tube including a selectively bendable portion, at least a portion of the tube being configured to be inserted into a blood vessel, a plug disposed at a distal end of the tube, the plug having a rounded tip configured to be inserted into a blood vessel, a washer disposed between the plug and the tube, the washer being fixed to the tube, and a control element extending through at least a portion of the tube, a distal end of the control element being connected to the washer and configured to bend the selectively bendable portion of the tube by movement of the control element relative to the tube. An intravascular device comprising.

[0086]

[0105] Example 2

[0106] A tube including a selectively bendable portion, a plurality of slots formed in the tube, each of the slots being partially disposed around the tube, a control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion and configured to bend the selectively bendable portion by movement of the control element relative to the tube, and a spacer disposed within the tube and installed between the tube and the control element, the spacer including a solid configured to reduce sliding friction between the tube and the control element. An intravascular device comprising.

[0087]

[0107] Example 3

[0108] A vascular device comprising a tube having a selectively bendable portion configured to bend in a first direction, a plurality of slots formed in the selectively bendable portion, the plurality of slots including a first slot facing in the first direction and a 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, and a control element extending through the tube, the control element being connected to a distal portion of the selectively bendable portion and configured such that movement of the control element relative to the tube causes the selectively bendable portion to bend.

[0088]

[0109] Example 4

[0110] A vascular device comprising a tube having a selectively bendable portion configured to bend in a first direction, a plurality of slots formed in 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 and configured such that movement of the control element relative to the tube causes the selectively bendable portion to bend, and a friction element formed as a second tube disposed around the control element within the tube and fixed to the control element, at least a portion of the second tube contacting an inner wall of the tube to increase friction between the control element and the tube.

[0089]

[0111] Example 5

[0112] A tube including a first selectively bendable portion and a second selectively bendable portion, and a first control element extending through at least a portion of the tube, wherein a distal end of the first control element is connected to a distal end of the first selectively bendable portion and is configured to cause movement of the first selectively bendable portion by movement of the first control element relative to the tube; and a second control element extending through at least a portion of the tube, wherein a distal end of the second control element is connected to a distal end of the second selectively bendable portion and is configured to cause movement of the second selectively bendable portion of the tube by movement of the second control element relative to the tube. An intravascular device comprising the above components.

[0090]

[0113] Example 6

[0114] The actuator control unit is disposed at the proximal end of the tube. The actuator control unit includes a first handle slidable relative to the tube and connected to the first control element such that movement of the first handle causes movement of the first control element, and a second handle slidable relative to the tube and connected to the second control element such that movement of the second handle causes movement of the second control element. The intravascular device of Example 5 includes the above components.

[0091]

[0115] Example 7

[0116] The first handle and the second handle are configured to move independently of each other. The intravascular device of Example 6 includes the above components.

[0092]

[0117] Example 8

[0118] The first control element is formed as a wire or cable, and the second control element is formed as a second tube. The intravascular device according to any one of Examples 5 to 7 includes the above components.

[0093]

[0119] Example 9

[0120] The second control element is disposed around the first control element. The intravascular device according to any one of Examples 5 to 8 includes the above components.

[0094]

[0121] Example 10

[0122] By the movement of the first handle in the first axial direction, the first selectively bendable portion moves in the first direction, and by the movement of the first handle in the second axial direction, the first selectively bendable portion moves in the second direction. By the movement of the second handle in the first axial direction, the second selectively bendable portion moves in the third direction, and by the movement of the second handle in the second axial direction, the second selectively bendable portion moves in the fourth direction. The intravascular device according to any one of Examples 6 to 9.

[0095]

[0123] Example 11

[0124] The magnitude of the movement of the first handle corresponds to the magnitude of the movement of the first selectively bendable portion, and the magnitude of the movement of the second handle corresponds to the magnitude of the movement of the second selectively bendable portion. The intravascular device according to any one of Examples 6 to 9.

[0096]

[0125] Example 12

[0126] The first selectively bendable portion is adjacent to the second selectively bendable portion, or the first selectively bendable portion is separated from the second selectively bendable portion by a non-bendable portion of the tube. The intravascular device according to any one of Examples 5 to 11.

[0097]

[0127] Example 13

[0128] The first friction element is disposed within the tube, and the first friction element is configured to increase the friction between the tube and the first control element as the first control element moves relative to the tube. The second friction element is disposed within the tube, and the second friction element is configured to increase the friction between the tube and the second control element as the second control element moves relative to the tube. The first friction element and the second friction element are each configured to maintain the positions of the first portion of the handle and the second portion of the handle in the absence of an external input to the first portion of the handle or the second portion of the handle. An intravascular device according to any one of Examples 5 to 12.

[0098]

[0129] Example 14

[0130] The tube includes a plurality of slots, each of the slots being disposed partially around the tube. An intravascular device according to any one of Examples 5 to 13.

[0099]

[0131] According to one embodiment, at least one slot set of the plurality of slots is disposed in at least a first selectively bendable portion and a second selectively bendable portion.

[0100]

[0132] Example 15

[0133] Including a first spacer, the first spacer is disposed within the tube and installed between the tube and the first control element. The first spacer includes a solid configured to reduce the sliding friction between the tube and the first control element. An intravascular device according to any one of Examples 5 to 14.

[0101]

[0134] According to one embodiment, the intravascular device includes a second spacer, the second spacer is disposed within the tube and installed between the tube and the second control element. The second spacer includes a solid configured to reduce the sliding friction between the tube and the second control element and between the second control element and the first control element.

[0102]

[0135] According to one embodiment, the first spacer and the second spacer include a coil formed from a wire or a plurality of wires.

[0103]

[0136] According to one embodiment, the first spacer and the second spacer are at least partially formed from a material selected from the group consisting of a metal alloy and a fluoropolymer material.

[0104]

[0137] Example 16

[0138] At least one washer is disposed within the tube, the washer is fixed to the tube, and at least one of the first control element and the first spacer is connected to the washer, and at least one of the second control element and the second spacer is connected to the washer. The intravascular device according to any one of Examples 5 to 15.

[0105]

[0139] Example 17

[0140] The tube further includes a third selectively bendable portion, and a third control element extending through at least a portion of the tube, wherein a distal end of the third control element is connected to a distal end of the third selectively bendable portion, and the movement of the third control element relative to the tube causes the third selectively bendable portion to move. The intravascular device according to any one of Examples 5 to 16, further comprising a third control element configured to cause movement.

[0106]

[0141] Example 18A

[0142] At least one washer is disposed within the tube. The intravascular device according to any one of Examples 1 to 4.

[0107]

[0143] According to one embodiment, the washer is rotatably fixed relative to the axis of the tube such that the selectively bendable portion is bent by applying torque to the control element.

[0108]

[0144] According to one embodiment, the washer is disposed within the tube, the washer is fixed to the tube, and at least one of the control element and the spacer is connected to the washer.

[0109]

[0145] Example 18B

[0146] The intravascular device according to any one of Examples 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 metal alloys, stainless steel, and polymeric materials.

[0110]

[0147] Example 19

[0148] The intravascular device according to any one of Examples 1 to 18B, wherein the control element is configured to slide relative to at least a portion of the tube.

[0111]

[0149] Example 20

[0150] The intravascular device according to any one of Examples 1 to 19, wherein the control element extends through the tube from a washer at the distal end of the tube to the proximal end of the tube.

[0112]

[0151] Example 21

[0152] The intravascular device according to any one of Examples 1 to 20, wherein the diameter of the control element tapers from the proximal end of the tube to the distal end of the tube.

[0113]

[0153] Example 22

[0154] The intravascular device according to any one of Examples 1 to 21, wherein the portion of the wire closer to the distal end of the tube has a rectangular cross-section and the portion of the wire closer to the proximal end of the tube has a circular cross-section.

[0114]

[0155] Example 22A

[0156] The portion of the control element having a rectangular cross-section has an increasing width of the rectangular cross-section as the distance from the distal end decreases, and the portion of the control element having a circular cross-section has a decreasing diameter as the distance to the distal end increases, the intravascular device of Example 22.

[0115]

[0157] Example 22B

[0158] The portion of the control element having a rectangular cross-section has a first width in which at least a first stage of the control element has a first width greater than a second width of a second stage of the control element, and the first stage is closer to the distal end than the second stage, the intravascular device of Example 22A in which the length increases stepwise.

[0116]

[0159] Example 23

[0160] A spacer is disposed within the tube and installed between the tube and the control element, the spacer includes a solid configured to reduce sliding friction between the tube and the control element, and the spacer is connected to a washer, the intravascular device according to any one of Examples 1 to 22B.

[0117]

[0161] According to one embodiment, the spacer circumferentially surrounds at least a portion of the wire.

[0118]

[0162] According to one embodiment, the spacer includes a wire formed into a coil.

[0119]

[0163] According to one embodiment, the spacer includes a plurality of wires formed into a coil.

[0120]

[0164] According to one embodiment, the coil has a first portion, a second portion, and a third portion, and each of the first portion, the second portion, and the third portion has a different diameter.

[0121]

[0165] According to one embodiment, the spacer includes a second tube installed between the wire and the tube.

[0122]

[0166] According to one embodiment, the second tube has a first portion, a second portion, and a third portion, and each of the first portion, the second portion, and the third portion has a different diameter.

[0123]

[0167] According to one embodiment, the tube circumferentially surrounds at least a portion of the second tube.

[0124]

[0168] According to one embodiment, the spacer is at least partially formed from a radiation-opaque material.

[0125]

[0169] Example 24

[0170] The tube includes a plurality of slots, and each of the slots is partially disposed around the tube. The intravascular device according to any one of Examples 1 to 23.

[0126]

[0171] According to one embodiment, at least one slot set of the plurality of slots is disposed in a selectively bendable portion.

[0127]

[0172] Example 25

[0173] At least two slots of the plurality of slots are disposed in a selectively bendable portion. A first slot set including one of the two slots faces in a first direction, and a second slot set including the other of the two slots faces in a second direction different from the first direction such that each first range of the first slot set is larger than each second range of the second slot set. The intravascular device according to any one of Examples 1 to 24.

[0128]

[0174] According to one embodiment, each of the first slot sets has a larger area than each of the second slot sets.

[0129]

[0175] According to one embodiment, each of the slots of the first slot set has a different shape from each of the slots of the second slot set. 【013

[0176] According to one embodiment, when the wire is moved, the range difference between the first slot set and the second slot set biases the selectively bendable portion to bend in the first direction.

[0131]

[0177] According to one embodiment, the second plurality of slots are formed in a portion of the tube remote from the selectively bendable portion, the second plurality of slots are symmetrically distributed around the tube, and the second plurality of slots enhance the flexibility of the tube in that portion.

[0132]

[0178] According to one embodiment, the second direction is oriented to face a different radial direction than the first direction.

[0133]

[0179] According to one embodiment, the distance between the third slot and the fourth slot adjacent to each other is smaller than the distance between the fifth slot and the sixth slot adjacent to each other, and the fifth slot and the sixth slot are closer to the proximal end of the tube than the third slot and the fourth slot.

[0134]

[0180] Example 26

[0181] The tube further includes a non-bendable portion configured to remain in a non-bent configuration when the selectively bendable portion is bent, the intravascular device according to any one of Examples 1-25.

[0135]

[0182] According to one embodiment, the non-bendable portion is adjacent to the selectively bendable portion.

[0136]

[0183] According to one embodiment, the non-bendable portion is separated from the selectively bendable portion by a third portion of the tube.

[0137]

[0184] Example 27

[0185] The plug is disposed at the distal end of the tube, and the plug has a rounded tip configured to be inserted into a blood vessel, the intravascular device according to any one of Examples 1 to 26.

[0138]

[0186] Example 28

[0187] The actuator control unit is disposed at the proximal end of the tube, and the actuator control unit includes a handle slidable with respect to the tube and connected to the control element such that the control element moves with the movement of the handle, the intravascular device according to any one of Examples 1 to 27.

[0139]

[0188] Example 29

[0189] The friction element is disposed within the tube, and the friction element is configured to increase the friction between the tube and the wire as the wire moves relative to the tube, the intravascular device according to any one of Examples 1 to 28.

[0140]

[0190] According to one embodiment, the friction element is configured to maintain the position of the handle in the absence of an external input to the handle.

[0141]

[0191] According to one embodiment, the friction element is formed as a second tube disposed around and fixed to the control element within the tube, and at least a portion of the second tube contacts the inner wall of the tube to increase the friction between the control element and the tube.

[0142]

[0192] According to one embodiment, the second tube is formed with at least one angle, and the portion of the second tube including the angle contacts the inner wall of the tube.

[0143]

[0193] Example 30

[0194] A method for guiding an intravascular device through a vascular system, comprising receiving a medical image taken during an intravascular procedure, analyzing the medical image to detect a target region where the path of the vascular system to the 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 positioned in the target region, and controlling the curvature of the specific portion of the intravascular device.

[0144]

[0195] Example 31

[0196] A method for guiding a catheter through a blood vessel, comprising steering an intravascular device configured as a guide wire through the blood vessel to a target location, the intravascular device comprising a selectively bendable portion, positioning the intravascular device at the target location, the target location including a location along the blood vessel, actuating the selectively bendable portion of the intravascular device to provide shape retention for creating a tip shape, increasing support, and / or orienting the selectively bendable portion of the intravascular device, and advancing a catheter on the guide wire to guide the catheter through the blood vessel to the target location.

[0145]

[0197] Example 32

[0198] The method according to Example 30 or 31, comprising scrutinizing a medical image to detect the distal tip of the intravascular device and determining that a specific portion of the intravascular device is positioned in the target region based on the relative position of the distal tip and the relative position of the target region.

[0146]

[0199] Example 33A

[0200] The method according to Example 30 or 32, wherein the intravascular device is a catheter or a guide wire.

[0147]

[0201] Example 33B

[0202] The catheter is the method according to any one of Examples 30 to 33A, including a suction catheter or a microcatheter.

[0148]

[0203] Example 34A

[0204] The specific part of the intravascular device includes a selectively bendable part, and is the method according to any one of Examples 30 to 33B.

[0149]

[0205] According to one embodiment, the intravascular device includes a tube including a selectively bendable part, and a control element extending through the tube and connected to the distal part of the selectively bendable part.

[0150]

[0206] According to one embodiment, the tube includes a plurality of slots.

[0151]

[0207] According to one embodiment, the selectively bendable part includes a plurality of slots.

[0152]

[0208] According to one embodiment, at least a part of the tube includes a radiopaque material.

[0153]

[0209] According to one embodiment, the selectively bendable part includes a radiopaque material.

[0154]

[0210] Example 34B

[0211] When the intravascular device is a guide wire, the guide wire includes a tube proximal to the selectively bendable part, and a control element extending from the selectively bendable part through the proximal end of the tube, and is the method according to any one of Examples 30 to 34A.

[0155]

[0212] According to one embodiment, the selectively bendable part of the guide wire includes a distal tip.

[0156]

[0213] According to one embodiment, the distal tip of the guide wire is sealed.

[0157]

[0214] According to one embodiment, the guide wire includes a spacer installed between the control element and the tube.

[0158]

[0215] According to one embodiment, the spacer includes a coil formed from a wire or a plurality of wires.

[0159]

[0216] Example 35

[0217] The intravascular device is the intravascular device according to any one of Examples 1 to 29, and the method according to any one of Examples 30 to 34B.

[0160]

[0218] Example 36

[0219] At least a part of a specific portion of the intravascular device is radiopaque, and the method according to any one of Examples 30 to 35.

[0161]

[0220] Example 37

[0221] The method includes determining that a specific portion of the intravascular device is positioned in the target region based on the radiopacity of the specific portion, and the method according to any one of Examples 30 to 36.

[0162]

[0222] Example 38

[0223] Controlling the curvature of a specific portion of the intravascular device includes applying tension to a control element connected to the specific portion of the intravascular device, and the method according to any one of Examples 30 to 37.

[0163]

[0224] According to one embodiment, controlling the curvature includes moving the control element to bend a selectively bendable portion.

[0164]

[0225] Example 39

[0226] The method includes causing an operation involving the distal tip of the intravascular device after controlling the curvature of a specific portion of the intravascular device, and controlling the curvature of the specific portion of the intravascular device after causing the operation, and the method according to any one of Examples 30 to 38.

[0165]

[0227] According to one embodiment, the method includes receiving a second medical image captured during an intravascular procedure after causing an operation, and analyzing the second medical image to determine completion of the operation.

[0166]

[0228] According to one embodiment, the method includes receiving a signal from a sensor included in an intravascular device after causing an operation, and analyzing the signal to determine completion of the operation.

[0167]

[0229] According to one embodiment, the signal is at least one of a digital electromagnetic signal, an analog electromagnetic signal, and a mechanical signal.

[0168]

[0230] According to one embodiment, the operation involves the distal tip of an intravascular device within a target blood vessel.

[0169]

[0231] Example 40

[0232] The method includes analyzing a medical image to detect a second target region, scrutinizing the medical image to determine that a second portion of the intravascular device is positioned in the second target region, and controlling the curvature of a second portion of the intravascular device while simultaneously controlling the curvature of a particular portion of the intravascular device, the method according to any one of Examples 30 - 39.

[0170]

[0233] According to one embodiment, the particular portion and the second portion of the intravascular device are at least 1 centimeter apart.

[0171]

[0234] According to one embodiment, at least a portion of the second portion of the intravascular device is radiopaque.

[0172]

[0235] According to one embodiment, the method includes that determining that the second portion of the intravascular device is positioned in the second target region is based on the radiopacity of the second portion.

[0173]

[0236] According to one embodiment, controlling the curvature of a particular portion of the intravascular device or controlling the curvature of a second portion of the intravascular device does not cause a change in the curvature of at least one other portion of the intravascular device.

[0174]

[0237] According to one embodiment, at least one other portion of the intravascular device is distal to the particular portion of the intravascular device and the second portion of the intravascular device.

[0175]

[0238] Example 41

[0239] The method is the method according to any one of Examples 31 or 33 to 40, including advancing a catheter over a guide wire.

[0176]

[0240] According to one embodiment, advancing the catheter over the guide wire enables deflection of the catheter without an additional support.

[0177]

[0241] According to one embodiment, the additional support includes any one of a blood vessel, a second catheter, a second microcatheter, or a second guide wire.

[0178]

[0242] According to one embodiment, the blood vessel includes at least one of a curve, a bend, a loop, and a helical twist.

[0179]

[0243] According to one embodiment, the blood vessel is a cerebral blood vessel.

[0180]

[0244] Example 42

[0245] The target location is the method according to any one of Examples 31 to 41, adjacent to the blood clot.

[0181]

[0246] According to one embodiment, when the device is a guide wire, the guide wire does not move to a location distal to the blood clot.

[0182]

[0247] Example 43

[0248] The method includes removing a blood clot from a blood vessel by applying suction to a catheter (e.g., a suction catheter), the method according to any one of Examples 30 to 42.

[0183]

[0249] Example 44 The control element is connected to the distal section of the selectively bendable portion, the method according to any one of Examples 34 to 43.

[0184]

[0250] According to one embodiment, the control element is configured to enable selective bending of the selectively bendable portion of the guide wire by applying tension to the control element by an actuating force transmitted through the distal end of the control element.

[0185]

[0251] According to one embodiment, the proximal end of the control element is connected to an actuator control unit.

[0186]

[0252] According to one embodiment, the actuator control unit is configured to apply an actuating force to the proximal end of the control element to cause relative movement between the control element and the tube and to actuate the selectively bendable portion.

[0187]

[0253] Example 50

[0254] A non - transitory computer - readable medium including instructions for causing at least one processor to perform operations for selective deflection of different portions of an intravascular device, the operations including receiving a medical image taken during an intravascular procedure, analyzing the medical image to detect a target region where a change in the curvature of the intravascular device is required to facilitate guidance through a target blood vessel, evaluating the medical image to detect an intravascular device extending through the target blood vessel, determining that a particular portion of the intravascular device is positioned in the target region, and controlling the curvature of the particular portion of the intravascular device.

[0188]

[0255] Example 51

[0256] A non - transitory computer - readable medium including instructions for causing at least one processor to perform operations for selective deflection of different portions of an intravascular device, the operations comprising: steering an intravascular device configured as a guidewire through a blood vessel to a target location, the intravascular device including selectively bendable portions; positioning the intravascular device at the target location, the target location including a location along the blood vessel; actuating the selectively bendable portions of the intravascular device to provide shape retention for creating a tip shape, increasing support, and / or orienting the selectively bendable portions of the intravascular device; advancing a catheter on the guidewire to the target location to guide the catheter through the blood vessel.

[0189]

[0257] It should be understood that the sections of the detailed description, not the abstract and summary sections, are intended to be used in interpreting the claims. The abstract and summary sections may describe one or more exemplary embodiments contemplated by the inventors, but not all exemplary embodiments, and thus are not intended to limit the invention and the appended claims in any way. Further, the above - mentioned examples do not limit the present disclosure to what is particularly shown and described above. Rather, the scope of the present disclosure includes combinations and sub - combinations of the various features described above, as well as variations and modifications thereof that are recalled by those skilled in the art upon reading the above description and are not disclosed in the prior art.

[0190]

[0258] The use of the modifiers "approximately" or "about" in this disclosure is intended to indicate that the associated element is subject to variations due to tolerances. Unless otherwise defined, the use of these modifiers with respect to a unit of measurement means a tolerance of plus or minus 10 percent of that unit of measurement. The use of these modifiers with respect to descriptions such as shape is intended to allow for variations in that shape due to tolerance issues generally understood to occur in the art.

[0191]

[0259] The description of the foregoing specific embodiments is to fully disclose the general nature of the present invention so that others can readily modify and / or adapt such specific embodiments for various uses by applying the knowledge within those skilled in the art without undue experimentation and without departing from the general concept of the present invention. Thus, such adaptations and modifications are intended to be within the meaning and scope of the equivalents of the disclosed embodiments based on the teachings and guidance presented herein. It should be understood that the terms or technical terms in this specification are for the purpose of explanation and not for the purpose of limitation. Therefore, the terms or technical terms in this specification should be interpreted by those skilled in the art in light of the teachings and guidance.

[0192]

[0260] The various features of the present invention described in the context of separate embodiments for clarity can also be provided in combination in a single embodiment. Conversely, the various features of the present invention described in the context of a single embodiment for brevity can also be provided separately or in any suitable partial combination.

[0193]

[0261] 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. A tube including a selectively bendable portion, A plurality of slots formed in the pipe, each of which is a plurality of slots partially arranged around the periphery of the pipe, A control element extending through the tube, wherein the control element is connected to the distal portion of the selectively bendable portion, and the movement of the control element relative to the tube causes the selectively bendable portion to bend; A spacer disposed within the pipe and installed between the pipe and the control element, the spacer including a solid configured to reduce sliding friction between the pipe and the control element, Intravascular devices, including those mentioned above.

2. The intravascular device according to claim 1, wherein the spacer surrounds at least a portion of the control element in the circumferential direction.

3. The intravascular device according to claim 1 or 2, wherein the spacer includes a wire formed in a coil or a plurality of wires formed in a coil.

4. The intravascular device according to claim 1 or 2, wherein the spacer includes a second tube installed between the control element and the tube.

5. The intravascular device according to claim 3, wherein the coil has a first portion, a second portion, and a third portion, each of which has a different diameter.

6. The intravascular device according to claim 4, wherein the second tube has a first portion, a second portion, and a third portion, each of which has a different diameter.

7. The intravascular device according to claim 1 to 6, wherein the spacer is formed from at least partially radiopaque material.

8. The intravascular device according to claim 1 or 2, further comprising a plug positioned at the distal end of the tube, the plug having a rounded tip configured to be inserted into a blood vessel.

9. The intravascular device according to claim 1 or 2, further comprising a washer disposed within the tube, wherein the washer is fixed to the tube, and at least one of the control element and the spacer is connected to the washer.

10. The intravascular device according to claim 1 or 2, further comprising an actuator control unit located at the proximal end of the tube, wherein the proximal end of the control element is connected to the actuator control unit.

11. At least two of the slots of the plurality of slots are located in the selectively bendable portion, and the first set of slots, including one of the two slots, faces the first direction. The second set of slots, including the other of the two slots, faces a second direction different from the first direction, such that the first range of each of the first set of slots is greater than the second range of each of the second set of slots. The intravascular device according to claim 1 or 2.

12. The intravascular device according to claim 11, wherein each of the first slot set has a larger area than the second slot set, or has a different shape from each of the slots in the second slot set, or is oriented such that the first direction is radially opposite to the second direction.

13. The intravascular device according to claim 1 or 2, further comprising a lubricating element disposed in the tube and configured to reduce friction between the control element and the tube.

14. The intravascular device according to claim 1 or 2, wherein the control element is coated with a friction-reducing material.

15. The intravascular device according to claim 1 or 2, wherein the control element extends through the tube from the distal end of the tube to the proximal end of the tube.

Images