WO2025088528A1

WO2025088528A1 - Actuator control for guidable endovascular mesh device, and applications thereof

Info

Publication number: WO2025088528A1
Application number: PCT/IB2024/060448
Authority: WO
Inventors: Giora Kornblau; Eyal KAUFMAN; Noam Perlis; Liran AVIRAM
Original assignee: Rapid Medical Ltd
Current assignee: Rapid Medical Ltd
Priority date: 2023-10-24
Filing date: 2024-10-23
Publication date: 2025-05-01
Anticipated expiration: 2026-04-24

Abstract

An actuation control or handle for an endovascular device includes a housing containing an actuator that is linked to a portion of an endovascular device extending into the handle. An actuator linkage joins the actuator and first portion to allow the actuator to apply a force to the first portion of the endovascular device. Buttons disposed on the housing allow a user to control the movement of the actuator. A slider disposed on the housing allows for manual actuation of a second portion of the endovascular device inside the housing.

Description

ACTUATOR CONTROL FOR GUIDABLE ENDOVASCULAR MESH DEVICE, AND APPLICATIONS THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS AND INCORPORATION BY REFERENCE

[0001] The following applications are incorporated herein by reference in their entirety: U.S. Provisional Application No. 63/592,730 filed on October 24, 2023 and U.S. Provisional Application No. 63/592,703 filed on October 24, 2023.

BACKGROUND

[0002] This disclosure relates to the field of endovascular medical devices. Specifically, this disclosure is related to endovascular devices intended to pass through a blood vessel of a patient to a target area inside the patient’s vasculature, and to perform a medical procedure.

[0003] An example of an endovascular treatment of the type relevant to this disclosure is the use of an endovascular device to treat narrowing, blockage, or hemorrhage in a blood vessel, including neurovascular, cardiovascular, and peripheral vasculatures. For instance, treatment of an acute stroke caused by a blockage of a blood vessel in the brain typically comprises either the intra-arterial administration of thrombolytic drugs such as recombinant tissue plasminogen activator (rtPA), mechanical removal of the blockage, or a combination of the two. These interventional treatments must occur within hours of the onset of symptoms. Both intra-arterial (IA) thrombolytic therapy and interventional thrombectomy involve accessing the blocked cerebral artery via endovascular techniques and devices.

[0004] Mechanical treatment involves the physical manipulation of the relevant structure to relieve the cause of the symptoms. For example, mechanical treatment of a blood clot involves the physical removal of the blood clot by various means, such as capturing the blood clot mechanically by use of a mesh, balloons, snares, or coils, with or without the addition of supporting techniques like the use of suction to remove the clot or stents to support the blood vessel. Another example of a mechanical treatment is the mechanical reshaping of blood vessels to improve blood flow, which is accomplished by the use of mechanical devices similar to those discussed above. [0005] The proximal end of the endovascular device is manipulated by the user to navigate the endovascular device through the patient and to deploy the mechanical treatment. This manipulation occurs through a handle fixed to the end of the endovascular device. The user grasps the handle and moves it longitudinally, along the axis of the endovascular device, during navigation. Different features of the endovascular device can also be activated by using the handle. For example, manual or electrical actuators can deploy or retract the mechanical treatment.

[0006] Actuation of the endovascular device and the various mechanical treatment options available requires precise, repeatable movements or manipulations of a handle structure to ensure optimal outcomes. These movements also tend to be relatively small in terms of displacement, making these movements difficult to perform manually with repeatable precision. Thus, there exists a need for systems and techniques to precisely perform the movements needed to actuate the endovascular device.

BRIEF SUMMARY

[0007] In a first embodiment, an actuation control for an endovascular device comprises a housing; an actuator disposed in the housing; an actuator linkage fixed to a portion of the actuator in the housing and connecting the portion of the actuator to a first portion of an endovascular device that is disposed inside the housing; and a button disposed on an exterior of the housing and configured to command a first movement of the portion of the actuator.

[0008] In an embodiment, a method of using an endovascular device comprises inserting a distal end of a body of the endovascular device into a blood vessel; navigating the body of the endovascular device to a target region of the blood vessel; and performing a mechanical treatment at the target region using a mechanical treatment portion of the body of the endovascular device.

[0009] In an embodiment, a handle for an endovascular device comprises a housing configured to receive a portion of the endovascular device; a fixing structure in the housing configured to link the portion of the endovascular device to the handle; and a bearing disposed in and fixed to the fixing structure and configured to receive the portion of the endovascular device, the bearing configured to allow the portion of the endovascular device to rotate about an axis of the endovascular device with respect to the handle. [0010] Certain aspects of the disclosure have other steps or elements in addition to or in place of those mentioned above. The steps or elements will become apparent to those skilled in the art from a reading of the following detailed description when taken with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

[0011] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present disclosure and, together with the description, further serve to explain the principles thereof and to enable a person skilled in the pertinent art to make and use the same.

[0012] FIG. l is a perspective view of an endovascular device according to an embodiment.

[0013] FIG. 2 is a partial side view of an endovascular device according to an embodiment.

[0014] FIG. 3 is a partial side view of the endovascular device of FIG. 2 in an alternative configuration.

[0015] FIG. 4 is a cross-section of a selectively bendable portion of an endovascular device according to an embodiment.

[0016] FIG. 5 is top and side view of a control element according to an embodiment.

[0017] FIG. 6 is cross-section view of the control element of FIG. 5 in an endovascular device according to an embodiment.

[0018] FIG. 7 is cross-section view of the control element of FIG. 5 in an endovascular device according to an embodiment.

[0019] FIG. 8 is top and side view of a control element according to an embodiment.

[0020] FIG. 9 is a detail view of a portion of an endovascular device according to an embodiment.

[0021] FIG. 10 is a detail view of a portion of an endovascular device according to an embodiment.

[0022] FIG. 11 is a perspective view of an actuation control for an endovascular device according to an embodiment.

[0023] FIG. 11A is a perspective view of the actuation control of FIG. 11 in a different configuration.

[0024] FIG. 12 is a detail view of the actuation control of FIG. 11 in a different configuration according to an embodiment. [0025] FIG. 13 is a detail view of a portion of the actuation control of FIG. 11 according to an embodiment.

[0026] FIG. 14 is a detail view of an actuation control for an endovascular device according to an embodiment.

[0027] FIG. 15 is a schematic of a bearing structure for an actuation control according to an embodiment

[0028] FIG. 16 is flow diagram of a method of using an actuation control according to an embodiment.

[0029] In the drawings, like reference numbers generally indicate identical or similar elements. Additionally, generally, the left-most digit(s) of a reference number identifies the drawing in which the reference number first appears.

DETAILED DESCRIPTION

[0030] Reference will now be made in detail to representative embodiments illustrated in the accompanying drawings. References to “one embodiment,” “an embodiment,” “an exemplary embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such a feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

[0031] Endovascular devices used to perform mechanical intravascular medical treatments need to be able to navigate through a blood vessel to reach the treatment site to deliver the mechanical treatment to the relevant treatment site. This can be difficult in situations where the blood vessels in question comprise multiple turns because the typical endovascular device is not able to actively bend to navigate a twist or turn. Further, existing systems often require multiple devices to accomplish mechanical treatment. For example, a guidewire is first navigated to the target region through a microcatheter, when the target region is reached, the guidewire is removed and a mechanical treatment device is advanced in place of the guidewire to the treatment site. This increases system complexity and the potential for misplacements and mistakes, and thus requires the user to be highly skilled at manipulating several devices simultaneously.

[0032] Thus, an embodiment of the present disclosure is an endovascular device having a body with a selectively bendable portion, a mechanical treatment portion, and a proximal portion. A control element, disposed inside at least a portion of the body and configured to slide with respect to the body, is configured to control a curvature of the selectively bendable portion to enable navigation of the device through the blood vessel and/or to control activation of the mechanical treatment portion. An activation tube is slidably disposed around at least part of the body, the activation tube is configured to selectively enable activation of the guidewire function of the device or deployment of the mechanical treatment portion.

[0033] This endovascular device has several benefits, including an improved ability to navigate through blood vessels, including torturous blood vessels, and the ability to selectively deploy a mechanical treatment combined in one device. Additional benefits are discussed below.

[0034] During navigation of the endovascular device, rotation of the endovascular device about its axis is often needed to maneuver the distal tip of the endovascular device. This rotation poses a problem for fixed handles because it requires the user to rotate the handle, which can lead to uncomfortable handle positions with respect to the user’s grip. This rotation also prevents the handle from being placed on a flat support surface, such as a table, which can be desirable during treatment. Thus, there is a need for an improved handle that allows for rotation of the endovascular device without requiring rotation of the handle.

[0035] Embodiments of the present disclosure include an actuation control such as a handle for an endovascular device that is free to rotate about the axis of the endovascular device. This is achieved by the use of a bearing arrangement at contact points between the handle and the endovascular device. These embodiments have several advantages, including allowing the user to maintain a steady grip arrangement while navigating the endovascular device. This also allows the handle to be placed on a support surface in a fixed orientation during navigation, which can be helpful during navigation of the endovascular device.

[0036] As seen in FIG. 1, an endovascular device 1 is formed as an approximately tubular device. Endovascular device 1 includes a distal end 2 and a proximal end 3 (also referred to as “distal tip” and “proximal tip”, respectively). Proximal end 3 is the end of endovascular device 1 that generally remains outside of a patient and is manipulated by a user (e.g., a doctor or other medical professional). Distal end 2 is the end of endovascular device 1 that is generally inserted into a blood vessel of the patient. In some embodiments, endovascular device 1 may have an overall length of between 1500 and 2500 millimeters (mm). In some embodiments, endovascular device 1 may have an overall length of about 1800-2200 mm. In specific embodiments, endovascular device 1 may have an overall length of about 2000 mm.

[0037] In embodiments, a body 100 of endovascular device 1 is formed as a tubular shape with three main segments: a selectively bendable portion 110, a mechanical treatment portion 160, and a proximal portion 170. As seen in FIG. 1, in some embodiments, these three segments are located adjacent to each other, with selectively bendable portion 110 being the portion of body 100 closest to distal end 2, mechanical treatment portion 160 being the next proximal segment, and finally proximal portion 170 being the most proximal of the three segments. In other embodiments, there may be other segments of body 100 between these three segments. For example, a tubular element, a cable, a connector, a stopper or any other element suitable to be placed between portions of a tubular device may be used. These three segments of body 100 can be joined through any suitable technique known in the art, including but not limited to, welding, soldering, brazing, adhesive, or mechanical connections such as intermediate sleeves, rings, fasteners, or splices.

[0038] It should be understood that selectively bendable portion 110 may be located proximally to the mechanical treatment portion 160. Furthermore, there may be additional selectively bendable portions 110 in endovascular device 1, such as for example, a selectively bendable portion 110 may be located distally with respect to bendable portion 110 and a second selectively bendable portion 110 may be located proximally with respect to mechanical treatment portion 160. Accordingly, device 1 may comprise one, two, three or more selectively bendable portions 110.

[0039] A control element 120 is disposed inside body 100 to control the bending of selectively bendable portion 110 and, in some embodiments, to enable expansion and retraction of mechanical treatment portion 160, as will be discussed in detail below.

[0040] An activation tube 180 is slidably disposed around body 100. Activation tube 180 is sized to have a sliding fit with the outer surface of body 100. Activation tube 180 functions to enable selective activation of selectively bendable portion 110 or mechanical treatment portion 160 by its sliding properties over body 100. Specifically, activation tube 180 functions to enable selective activation of mechanical treatment portion 160 by sliding towards proximal end 3 and uncovering (also referred to as “unsheathing”) mechanical treatment portion 160 (as shown in FIG. 2, for example). Alternatively, activation tube 180 functions to enable selective activation of selectively bendable portion 110, and concomitantly deactivation of mechanical treatment portion 160 (as shown in FIG. 3) by sliding towards distal end 2 and covering (also referred to as “sheathing”) of mechanical treatment portion 160. According to one embodiment, activation tube 180 may be used to control the bending of selectively bendable portion 110, as will be discussed herein below. [0041] An actuation control 200 is formed around part of proximal portion 170 closest to proximal end 3. Actuation control 200 functions to control both selectively bendable portion 110 and activation tube 180. Actuation control 200 will be discussed in detail below.

[0042] As seen in FIGS. 2, 3, 4, and 6, in some embodiments body 100 can be formed as a cylinder with a central opening. According to one embodiment, body 100 is a tube. According to a specific embodiment body 100 is a hypotube. According to one embodiment, body 100 is a shaft. According to a specific embodiment, body 100 is a catheter shaft. Body 100 can be formed from any suitable material known in the art, such as metals or plastics, as discussed in detail below. As body 100 is intended to be at least partially inserted into a blood vessel, the material of body 100 should be biocompatible. Examples of materials for body 100 (e.g., for the entire body of body 100, or at least one of selectively bendable portion 110, mechanical treatment portion 160, and proximal portion 170, as well as any combinations thereof) are elastic and/or super-elastic polymers, super-elastic metals or various metals/alloys/oxides such, without being limited to, elastomers, silicon polymeric materials like Polydimethylsiloxane (PDMS), silicon adhesives, silicone rubbers, natural rubbers, thermoplastic elastomers, polyamide, polyimide, poly ethylene (PE), poly propylene (PP), polyether etherketone (PEEK), Acrylonitrile butadiene styrene (ABS), epoxys, polytetrafluoroethylene (PTFE), polyurethane, thermoplastic polyurethanes (TPU), Nylon, Polyether block amide (PeBax), Kevlar, stainless titanium, steel or stainless steel, nickel titanium alloy (Nitinol), nickelchromium alloy, nickel-chromium-iron alloy, cobalt alloy, tungsten, cobalt, chrome, nickel, aluminum, copper, molybdenum or any combination thereof. Materials opaque to X-rays, such as platinum, gold, tungsten, tantalum or the like, may be incorporated into body 100, or portions thereof, to act as a fluoroscopic marker to aid in visualization of the device in a blood vessel. According to a specific embodiment, selectively bendable portion 110 may be formed from stainless steel or nitinol, mechanical treatment portion 160 can be formed from nitinol, and proximal portion 170 can be formed from stainless steel or nitinol. In some embodiments, body 100 is configured to be elastically deformable along at least portions of its length, as will be explained below. According to a specific embodiment, body 100, mechanical treatment portion 160 or selectively bendable portion 110 may comprise at least one braided or coiled section.

[0043] In some embodiments, body 100 may have an outer diameter (OD) of between about 0.10 mm and about 1.10 mm. In some embodiments, body 100 may have an OD of between about 0.15 mm and about 0.90 mm. In some embodiments, body 100 may have an OD of between about 0.20 mm and about 0.40 mm. In specific embodiments, body 100 may have an OD of about 0.15 mm, about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.55 mm, about 0.65 mm, about 0.75 mm or about 0.80 mm. As mentioned above, body 100 can be formed as a cylinder with a central opening. According to some embodiments, body 100 may have an inner diameter (ID) of between about 0.10 mm and about 0.90 mm. In some embodiments, body 100 may have an ID of between about 0.20 mm and about 0.70 mm. In specific embodiments, body 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.

[0044] As mentioned, body 100 includes at least one selectively bendable portion 110 (shown in the straight configuration in FIG. 1, and in a partial bent configuration in FIGS. 2-3). As shown in FIG. 1, in some embodiments selectively bendable portion 110 is located at distal end 2. Selectively bendable portion 110 is controlled by actuation control 200 at proximal end 3. Thus, selectively bendable portion is a controllably bendable section being actuated by a control element (as further discussed hereinbelow). As will be explained in detail below, in some embodiments, the device can have multiple selectively bendable portions 110.

[0045] Selectively bendable portion 110 is a portion of body 100 that can be controllably bent with respect to the original axis of body 100. As will be discussed further below, selectively bendable portions 110 can be controlled by a user to improve navigation of endovascular device through the blood vessel of a patient. In some embodiments, selectively bendable portion 110 can extend between about 5 mm and about 50 mm in the axial direction along body 100. In some embodiments, selectively bendable portion 110 can extend between about 10 mm and about 30 mm in the axial direction along body 100. In specific embodiments, selectively bendable portion 110 can extend about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm or about 25 mm in the axial direction along body 100.

[0046] In some embodiments, as seen in FIGS. 4 and 6, openings 102 are formed in a portion of body 100. For example, as shown in FIGS. 4 and 6, openings 102 may be formed in selectively bendable portion 110. Openings 102 may also be formed in proximal portion 170 (not shown). As mentioned above, body 100 may be made of any suitable material, including medical grade stainless steel or nitinol. Openings 102 are portions removed from the material (e.g., cutouts). In some embodiments, these openings 102 are formed as slots in body 100 that penetrate at least partially around a circumference of body 100 from an exterior of body 100 to an interior of body 100. In some embodiments, openings 102 penetrate from the exterior of body 100 to the interior of body 100. In these embodiments, when endovascular device 1 is inserted into a patient’s blood vessel, fluid may penetrate through openings 102. In some embodiments, openings 102 do not extend around the entire circumference of body 100. Openings 102 can extend, for example, from between ten percent to ninety percent of the circumference of body 100.

[0047] In some embodiments, openings 102 can be formed as a regular, rectangular shape projected onto the surface of body 100. In these embodiments, for example, openings 102 can have a width in the axial direction of between about 0.01 mm and about 0.1 mm. According to specific embodiments, openings 102 can have a width in the axial direction of between about 0.02 mm and about 0.06 mm. Openings 102 can also be formed from different shapes projected onto the surface of body 100, such as slits, circles, ovals, triangles, or any other desired polygonal shape. Openings 102 may be etched from body 100, for example, using any manufacturing methods known in the art, such as by cutting or grinding, for example, with a disc, with a semiconductor dicing blade or using laser cutting.

[0048] By removing material from body 100, openings 102 reduce the stiffness or resistance to bending of body 100. Thus, openings 102 can be used to create more flexible or bendable portions of body 100. These are portions of body 100 that are more susceptible to being controllably bent, as will be discussed below. Changing the extent of openings 102 can therefore be used to control flexibility or softness of body 100. For example, increasing the extent, by increasing size, number, shape, or density of openings 102 will reduce the stiffness of body 100, or increase the tendency to bend. Conversely, reducing the extent by reducing the size, number, shape, or density of openings 102 increases the stiffness of body 100, or decreases the tendency to bend. Thus, in some embodiments selectively bendable portion 110 of body 100 has openings 102, while proximal portion 170 may not have any openings 102. In other embodiments, selectively bendable portion 110 may have openings 102, and proximal portion 170 may have openings 102 but of reduced size, number, or density as compared to the selectively bendable portion 110. Openings 102 on the selectively bendable portion may be asymmetric, in that openings 102 may be deeper, more frequent, larger in size and/or of a favorable shape on the side in the direction where the tip is bent. Alternatively, openings 102 on the selectively bendable portion may be symmetric, in that case, openings 102 may be equal in depth, frequency, size and/or shape, on both sides of the tube. In areas where the tube is not meant to bend when tension is applied, openings 102 may only serve to increase flexibility or softness of the tube.

[0049] It should be noted that body 100 may be able to bend to some degree without any openings 102 present. But, the addition of openings 102 allows for the creation of targeted selectively bendable portions 110. In some embodiments, openings 102 have identical dimensions, but have variable spacing between them. For example, openings 102 disposed in selectively bendable portion 110 may have a spacing of about 0.03 mm to about 0.2 mm (e.g., pitch of about 0.06 mm to about 0.3 mm). According to a specific embodiment, openings 102 disposed in selectively bendable portion 110 may have a spacing of about 0.08 mm to about 0.06 mm (e.g., pitch of about 0.12 mm to about 0.16 mm). Openings 102 in a separate, more proximal portion of body 100 may be smaller and may be spaced further apart, and may have a spacing of between about 0.03 mm to about 3 mm.

[0050] Another example of changing the extent of openings 102 is changes in spacing between openings 102. Larger spacing between openings 102 would increase the stiffness of body 100, while smaller spacing between openings 102 decreases the stiffness of body 100. This technique can be used to create variable gradients of stiffness to tailor the stiffness of body 100 as desired. For example, in some embodiments, the spacing or pitch of openings 102 in selectively bendable portion 110 is smaller at the end of selectively bendable portion 110 that is closest to distal end 2. In these embodiments, the spacing increases towards the end of selectively bendable portion 110 that is closer to proximal end 3. In this way, selectively bendable portion 110 is biased to be more flexible nearer distal end 2, which is the end that is inserted into the blood vessel first. The rate of change in spacing can be constant or can be variable to tailor the stiffness change as needed. In some embodiments, there are no openings 102 for a predetermined distance from proximal end 3 of body 100. This can be desirable to increase the stiffness of the proximal portion of body 100. This portion of body 100 may also be the portion of body 100 intended to remain outside of the patient during an endovascular procedure.

[0051] In some embodiments, the design or material of body 100 can also be used to adjust flexibility of body 100. For example, the cross-section dimensions or shape of body 100 may be altered to increase or decrease flexibility. Changing the material of body 100 can also change flexibility. A stiffer material will make the corresponding portion of body 100 less flexible, for example. This can be useful when flexibility changes are desired without changing external dimensions of body 100. These different materials can be joined together at a connection. The connection can be, for example, any suitable connection technique including, but not limited to, adhesives, welding, or use of a mechanical connector such as a ring or sleeve (used alone or in combination with other connecting techniques). As seen in FIGS. 1-3, in some embodiments there is a single selectively bendable portion 110 disposed at distal end 2 of body 100. This enables a portion of body 100 at distal end 2 to be more flexible, and thus selectively bendable. Selectively bendable portion 110 may also be disposed at various other points along body 100 as needed to increase flexibility and control. Accordingly, selectively bendable portion 110 may be disposed at a distal portion of endovascular device 1 which is not the distal end 2, such as up to about 150 mm from the distal end 2. As seen in FIGS. 4 and 6, in some embodiments this distally located, selectively bendable portion 110 is terminated at distal end 2 with a plug 112. Plug 112 acts to finish or seal distal end 2. Plug 112 is generally an atraumatic and non-sharp tip which typically has a rounded, oval, or similar shape to improve the ability of body 100 to transit inside a blood vessel in an atraumatic manner. A washer 114 is disposed between selectively bendable portion 110 and plug 112. Plug 112 and washer 114 can be fixedly connected to body 100 by any suitable method, including but not limited to, welding, soldering, brazing, adhesive, or mechanical connections such as fasteners or crimping. Both plug 112 and washer 114 can be made from any suitable biocompatible material, including for example metals, metal alloys/oxides, adhesives, silicones, and plastics, or any combination thereof. Materials opaque to X-rays, such as platinum, gold, tungsten, tantalum or the like, may be incorporated into the plug or washer, to act as a fluoroscopic marker to aid in visualization while navigating the device in a blood vessel.

[0052] As seen in FIGS. 2-4 and 6, for example, endovascular device 1 can include a control element 120 disposed inside body 100. Control element 120 can take the form of any suitably stiff element that can freely slide inside body 100. Sufficient stiffness is needed to prevent control element 120 from buckling excessively when it is put in compression (during the straightening of selectively bendable portion 110). However, control element 120 must also be sufficiently flexible such that it does not render body 100 too inflexible. The stiffness of control element 120 also affects the flexibility of selectively bendable portion 110, and thus the portion of control element 120 that transitions through selectively bendable portion 110 must be designed to allow for selectively bendable portion 110 to bend as desired. Control element 120 can be made of any suitable biocompatible material, including but not limited to, metals, metal alloys and plastics, or any combination thereof. According to one embodiment, control element 120 can be a solid wire, a multi-filament wire, a string, or a thread. For example, control element 120 can be a solid wire formed from any material known in the art, such as but not limited to, nitinol alloy, stainless steel, and a plastic material, or any combination thereof. According to a specific embodiment, control element 120 is a core wire. For example, control element 120 can be formed as a solid wire that is sized to fit inside body 100. Control element 120 can also take the form of a tube.

[0053] The function of control element 120 is to transmit force to selectively bend or straighten selectively bendable portion 110. As explained below, this also has the effect of controlling mechanical treatment portion 160. This is accomplished by fixing the distal end of 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 control element 120 is fixed to plug 112. According to one embodiment, the distal end of control element 120 is fixed to washer 114. According to one embodiment, washer 114 is in turn fixed to an end of selectively bendable portion 110. Because selectively bendable portion 110 may be placed anywhere along body 100, washer 114 may be located at different locations along body 100 depending on where selectively bendable portion 110 begins and ends. As seen in FIG. 6, in an embodiment, control element 120 passes through an opening in washer 114 and curves to fit into a groove 115 in washer 114. For example, as shown in FIG. 6, control element 120 extends through washer 114 traveling in an axial direction, and then curves approximately 180 degrees back to fit into groove 115, forming a u-shaped curve. In this way, control element 120 is fixed both axially and rotationally to washer 114 at distal end 2 of endovascular device 1. Examples of these types of curves are shown in FIGS. 4 and 6. In addition to passing through washer 114 as described, control element 120 may also be secured by adhesives and mechanical techniques such as a friction fit or the formation of additional bends/angles in control element 120. This manner of connecting control element 120 to washer 114 also improves the connection between body 100 and control element 120 because washer 114 substantially reduces the possibility of control element 120 separating from its fixed position with respect to body 100.

[0054] Control element 120 can otherwise slide freely inside body 100 to transmit force from actuation control 200 to washer 114 at distal end 2. From the straightened position shown in FIG. 1, retraction of control element 120 with respect to body 100 towards proximal end 3 will result in selectively bendable portion 110 bending to accommodate the shortened length of control element 120 (as seen in FIGS. 2-3). Conversely, extension of control element 120 towards distal end 2 will result in straightening of selectively bendable portion 110. The movement of control element 120 with respect to body 100 can be achieved by actuation control 200.

[0055] In some embodiments, control element 120 can be configured to increase the tendency for selectively bendable portion 110 to bend in a desired direction or directions. This is accomplished by altering the shape of control element 120 to increase its tendency to bend in a given direction or directions. Thus, control element 120 can have any lateral cross-section (perpendicular to the longitudinal axis) such as round, elliptic, square, rectangular, and the like.

[0056] For example, in embodiments like the one of FIGS. 4-8 control element 120 is formed from a solid wire with a varying cross section. Closer to proximal end 3, this embodiment of control element 120 has a circular cross section. As control element 120 continues in the distal direction, control element 120 flattens and has a rectangular cross section. The rectangular cross section tends to bend in the direction perpendicular to the long sides of the rectangle, creating a preferred or biased bending direction for selectively bendable portion 110 that control element 120 is disposed within.

[0057] Additionally or alternatively, control element 120 can maintain the same cross section, but change in size to alter bending tendencies. For example, control element 120 may maintain a circular cross section, but may increase or decrease in diameter to increase or reduce stiffness, respectively. This type of control element 120 would not have a biased bending direction because the cross-sectional shape is maintained but would instead have lesser or greater bending tendencies depending on the dimensions of control element 120. The dimensions of these changed areas of control element 120 can be varied to achieve the desired resistance to bending when combined with the properties of body 100. For example, an embodiment of this type of control element 120 can have different first, second, and third diameters at different locations along the length of control element 120.

[0058] For example, an embodiment of control element 120 is shown in FIG. 5, which shows a side view and top view of control element 120. In this embodiment, control element 120 has a constant diameter portion 120a, a tapered portion 120b, and a flattened portion 120c. Constant diameter portion 120a has a cross-section of a predetermined diameter, which may correspond to parts of control element 120 that are closer to proximal end 3 of body 100 when assembled into endovascular device 1. Tapered portion 120b has a diameter that constantly decreases as distance from constant diameter portion 120a increases. Flattened portion 120c has a rectangular cross-section (thus, it is flattened when compared to other parts of control element 120) that increases in width when viewed from the top as distance from tapered portion 120b increases. Flattened portion 120c can correspond to the selectively bendable portion 110, and thus can correspond to distal end 2 of body 100. A skilled artisan will understand that flexibility of control element 120 will increase in all bending directions in tapered portion 120b as distance from constant diameter portion 120a increases because of the reduction in diameter. Bending in flattened portion 120c is biased towards bending in the direction in and out of the drawing with respect to the top view because of the flattened cross section shape. This embodiment of control element 120 is shown in body 100 in FIG. 6, and a cross-section of FIG. 5 is shown in FIG. 7. [0059] According to a specific embodiment, control element 120 can be fixed to a portion of a mechanical treatment portion 160, which is another portion of endovascular device 1 discussed in detail below. For example, in cases in which a pre-shaped tip is used for the selectively bendable section (not shown), then the control element 120 is typically fixed to the distal end 162 of mechanical treatment portion 160, e.g., to the distal portion thereof. Additionally or alternatively, when more than one control elements 120 is used, different control elements 120 may be used to actuate different portions of the device, for example, one control element 120 may be fixed to mechanical treatment portion 160 and a second control element may be fixed to selectively bendable section 110. Regardless of the number of control elements used, control element 120 may be fixed to mechanical treatment portion 160 using any method known in the art, e.g., via a connector, plug or washer (as discussed above).

[0060] In some embodiments, constant diameter portion 120a ranges between about 0.1 and about 0.45, e.g., about 0.140 and about 0.180 mm in diameter. At its most proximal end, tapered portion 120b has the same diameter as constant diameter portion 120a. Tapered portion 120b can taper down to a diameter of between about 0.065 mm and about 0.2 mm. The taper may be evenly distributed (a linear taper) along the axial length of tapered portion 120b or can be unevenly distributed. Flattened portion 120c may have a width dimension that begins at the smallest diameter of tapered portion 120b and increases up to the diameter of constant diameter portion 120a. As seen in FIG. 5, there can be four steps of increasing width, with the first (most proximal) step ranging from about 0.100 mm to about 0.170 mm, the second step ranging from about 0.110 mm to about 0.180 mm, the third step ranging from about 0.120 mm to about 0.190 mm, and the fourth step ranging from about 0.130 mm to about 0.200 mm. Here, the width dimension is being defined as the dimension in the top to bottom direction of FIG. 5 with respect to the lower top view. It should be understood that there can be more or less steps in flattened portion 120c as needed or desired to adjust flexibility. Flattened portion 120c can also be flatted and expand in width in a gradual, nonstepwise fashion, as shown in FIG. 8.

[0061] Biased bending as discussed above can also be achieved by distributing the open areas caused by openings 102 unevenly with respect to the circumference of body 100. Thus, having asymmetric slots having openings with a greater extent (more open area) facing in a first radial direction and slots with a smaller extent (less open area) facing in a second radial direction (e.g., direction opposite the first radial direction), biases the bending of the selectively bendable portion 110 in the first direction when the control element 120 is moved by actuator control 200. For example, making openings 102 larger on one side of body 100 would bias body 100 to bend in the direction of that side. Using any combination of these methods to bias the bending of body 100 has the advantages of providing predictable bending for the user of endovascular device 1. This is particularly helpful when distal end 2 of body 100 has been inserted into a blood vessel and is not visible. The orientation of the remainder of body 100 (present outside of the blood vessel) allows the user to understand the direction that the distal end of body 100 with such a bias will bend with respect to the blood vessel.

[0062] In some embodiments, there can be two or more selectively bendable portions of body 100. These selectively bendable portions of body 100 may include biased bending region accomplished by having an asymmetrical distribution of openings 102 as discussed above.

[0063] The same body 100 having asymmetrical distribution of openings 102 at the one or more selectively bendable portions of body 100 can also have a symmetrical set of openings disposed in a different portion of body 100. These symmetrical openings 102 improve flexibility of body 100 without introducing any directional bias. For example, some or all of proximal portion 170 may have symmetrical opening 102. Finally, the same body 100 may have a portion without any openings 102, for example, on the portion of body 100 intended to remain outside of the patient during the procedure. This has the effect of gradually increasing stiffness of body 100 in the proximal direction (towards proximal end 3). Finally, a portion of body 100 that is proximal to non-bending portion 118 has no openings 102. These features provide the endovascular device with a soft, flexible and controllable distal section which is optimal for navigation in torturous anatomy, while providing support, shape retention and maintaining optimum torque transmission and tailored pushability in the more proximal sections. In some embodiments, the symmetrical openings 102 are formed as a rectangular slot that is projected or wrapped around some portion of the circumference of tube 100. In these embodiments, this portion may be anywhere between 0° and 350° of the circumference of tube 100. The slot that is projected can be between 0.01 mm and 0.1 mm in width, and the pitch or spacing between slots (openings 102) can be between 0.04 mm and 50 mm. The orientation of the openings 102 can also be varied in different ways. For example, the ends of the openings 102 can be located at varying positions in terms of rotation about the axis of tube 100. This means that the solid portion of tube 100 between the ends of each opening 102 can be offset rotationally with respect to adjacent openings 102. In some embodiments, this results in openings 102 being interleaved rotationally. In some embodiments, this offset can be arranged in a pattern such that each opening 102 is rotated a specific predetermined angular amount with respect to adjacent openings 102. For example, each opening 102 may be rotated 90 degrees with respect to the adjacent openings 102, which means that the openings 102 would form a repeating pattern in terms of their rotational alignment. Any desirable symmetrical or asymmetrical rotational alignment of openings 102 is possible. That is, the predetermined amount of rotational offset can be the same or can vary as desired between adjacent openings 102.

[0064] In other embodiments, opening 102 can be inclined with respect to the axis of tube 100 at an angle between zero and ninety degrees. This inclination may be easier to manufacture than strictly perpendicular opening. This angle can be measured with slots that have at least one elongated or linear side, such as slots that are formed from projected rectangles. That is, the angle is taken as the angle between the elongated side and the axis of tube 100. Openings 102 can be formed at a desired angle instead of being perpendicular to the axis of tube 100. Any desired angle can be used to slant openings 102, and the same discussion above with respect to staggering the solid portions of tube 100 applies here. In these embodiments, this portion may be anywhere between 0° and 350° of the circumference of tube 100. The slot that is projected can be between 0.01 mm and 0.1 mm in width, and the pitch or spacing between slots (openings 102) can be between 0.04 mm and 50 mm. In some embodiments, openings 102 can include both inclined and perpendicular orientations in different sections of tube 100.

[0065] Other suitable constructions of selectively bendable portion 110 include those disclosed by U.S. Patent No. 10,918,834, which is incorporated herein by reference in its entirety.

[0066] In some embodiments, at least a portion of body 100 includes a cable formed of a plurality of wound wires. The cable may include a proximal segment, at least one transition segment, and a distal segment. The distal segment of the cable may include selectively bendable portion 110. Typically, the distal segment includes a different number of wires compared to the proximal section. For example, the proximal segment may include a first number of wires, and the distal segment may include a second number of wires, the second number of wires being less than the first number of wires. For example, the proximal segment may include a first number of wires (e.g., in a range of 2-20 wires, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 wires) and the distal segment may include a second number of wires (e.g., in a range of 1-11 wires, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 wires). The transition segment being the point of reduction in the number of wires in the cable. Alternatively, the second number of wires may comprise more wires than the first number of wires. For example, the proximal segment may include a first number of wires (e.g., in a range of 1- 11 wires, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 wires) and the distal segment may include a second number of wires (e.g., in a range of 2-20 wires, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 wires). The transition segment being the point of increase in the number of wires in the cable.

[0067] According to an embodiment, selectively bendable portion 110 of body 100 can be fabricated from a plurality of wires twisted to form a cable. Such a cable is configured to exhibit sufficient pliability to enable flexibility and control of selectively bendable portion 110. According to one embodiment, the plurality of wires twisted to form the cable comprise one or more of the wires used to fabricate the mesh (as discussed in detail below). According to one embodiment, the plurality of wires twisted to form the cable comprise all of the wires used to fabricate the mesh (as discussed in detail below). According to one embodiment, the plurality of wires twisted to form the cable comprise some of the wires used to fabricate the mesh, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 wires used to fabricate the mesh (as discussed in detail below).

[0068] In some embodiments, selectively bendable portion 110 of body 100 is fabricated from a plurality of wires twisted to form a cable, while a proximal portion 170 of body 100 may not have any openings 102. In other embodiments, selectively bendable portion 110 is fabricated from a plurality of wires twisted to form a cable, while proximal portion 170 may have openings 102 but of size, number, or density to enable sufficient stiffness to body 100. Alternatively, selectively bendable portion 110 of body 100 may comprise slots as discussed in detail herein above, while proximal portion 170 of body 100 may be fabricated from a plurality of wires twisted to form a cable. Such a cable is configured to exhibit sufficient stiffness to enable torque of device 1 and control of selectively bendable portion 110 and mechanical treatment portion 160. According to one embodiment, the plurality of wires twisted to form the cable comprise one or more of the wires used to fabricate the mesh (as discussed for the selectively bendable portion 110 above).

[0069] Movement of control element 120 within body 100 can cause friction. In some embodiments, control element 120 can be coated to reduce friction. Suitable coatings for control element 120 include polymers and elastomers. For example, polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), nylon, may be used to coat control element 120 to reduce friction when control element 120 moves with respect to tube 100. Suitable coatings can be formed by any method known in the art, as discussed above. [0070] Additionally or alternatively, to reduce the friction generated between control element 120 and body 100, endovascular device 100 may include a spacer 130.

[0071] As seen in FIGS. 4 and 6, spacer 130 can be disposed between control element 120 and the inside of body 100. Spacer 130 acts as a spacer and guide that confines the movement of control element 120 inside body 100. In these embodiments, and as discussed in the following paragraphs, spacer 130 is described as a solid material. However, spacer 130 may also include a liquid lubrication element, or may only be a liquid lubrication. For example, an oil can be added to the interior of body 100 (e.g., near distal end 2). This oil can reduce friction between control element 120 and body 100. Examples of suitable oils can include, without limitation, a silicone oil.

[0072] Spacer 130 is fixed with respect to the interior of body 100. Suitable means for fixing spacer 130 to body 100 include, but are not limited to, welding, soldering, brazing, using adhesives, and mechanical connections. In some embodiments, a connector 132 fixes spacer 130 to body 100. In other embodiments, spacer 130 can be fixed to washer 114 using any method known in the art, such as with an adhesive, which in turn means spacer 130 is fixed to body 100 because washer 114 is fixed to body 100. According to an alternative embodiment, spacer 130 is fixed to tube 100 in a location closer to distal end 2. Accordingly, spacer 130 may be fixed at any location along tube 100 so as to enable longitudinal movement of control element 120. According to one embodiment, spacer 130 can completely surround control element 120 circumferentially. Alternatively, spacer 130 can only partially surround control element 120 circumferentially. In some embodiments, spacer 130 extends the entire length of body 100. In other embodiments, spacer 130 extends only a portion of the axial length of body 100. In other embodiments, spacer 130 extends the portion of the selectively bendable portion of body 100. In some embodiments, spacer 130 extends 1 to 50 percent of the axial length of tube 100. In other embodiments, spacer 130 extends 5 to 30 percent of the axial length of tube 100. In other embodiments, spacer 130 extends 10 to 30 percent of the axial length of tube 100. Furthermore, spacer 130 may be placed at any section along the tube, e.g. at the distal end of the tube, proximal end of the tube, or anywhere in between. In specific embodiments, spacer 130 can extend about 10 mm to 500 mm in the axial direction along tube 100. According to a specific embodiment, spacer 130 can extend about 10 mm, 25 mm, 50 mm, 75 mm, 100 mm, 150 mm, 200 mm, 250 mm, 300 mm, 350 mm, 400 mm, 450 mm or 500 mm in the axial direction along tube 100. Furthermore, spacer 130 may be placed at any section along the tube, e.g. at the distal end of the tube, proximal end of the tube, or anywhere in between.

[0073] In some embodiments, spacer 130 can be formed as a continuous tube of material. In other embodiments, spacer 130 can be formed from a strip or wire that is wrapped in a spiral or coil inside body 100. In other embodiments, spacer 130 can be formed from several strips of material or wires that are wrapped in a spiral or coil inside body 100. Other possible forms of spacer 130 include separate strips of material running the length of body 100, or discrete rings of material separated from each other. Spacer 130 may be formed from a biocompatible material that allows control element 120 to slide with respect to spacer 130. For example, but not limited to, spacer 130 can be made from a metal, a metal alloy/oxide, a silicone, and a plastic material, or any combination thereof. Exemplary materials of spacer 130 include nitinol, platinum, iridium, polytetrafluoroethylene (PTFE), a fluoropolymer, such as polytetrafluoroethylene.

[0074] In some embodiments, a coil-type spacer 130 is formed from a single wire shaped into a coil. The wire forming the coil has a diameter of between 0.020 mm to 0.200 mm. The coil of spacer 130 has a diameter of between 0.20 mm to 1.20 mm. The coil of spacer 130 has a pitch, which is the linear distance it takes the coil to complete a single rotation about its central axis and which can be measured by finding the linear distance between the same or common angular point on adjacent coils. This pitch can range from 1.5 to 20 times the wire diameter. These measurements, and particularly the pitch, have the benefit of ensuring that spacer 130 allows for bending of tube 100, particularly in selectively bendable portions 110. It should also be understood that coil-type spacers 130 may maintain the same dimensions (e.g., wire diameter, coil diameter, and pitch) throughout, or may vary these dimensions to achieve different effects, such as increased or decreased resistance to bending.

[0075] In some embodiments, the material selected for spacer 130 is radiopaque, which means spacer 130 is visible on an x-ray scan, or similar types of medical imaging, when placed in the body. This can be achieved by material selection, or by the addition of an additive or coating to spacer 130. For example, materials such as gold, platinum, tungsten, tantalum or the like, may be incorporated into spacer 130, to act as a fluoroscopic marker to aid in visualization. According to one embodiment, spacer 130 is at least partially formed from a material selected from the group consisting of a metal alloy and a fluoropolymer material to ensure spacer 130 is sufficiently radiopaque. In other embodiments, body 100 can be radiopaque, either by material selection (as discussed above) or by the addition of an additive or coating (discussed below).

[0076] Further details regarding selectively bendable portion 110, including control thereof, can be found in PCT/IB2023/057241 filed July 14, 2023, which is incorporated herein by reference.

[0077] In embodiments as shown in FIGS. 2-3, mechanical treatment portion 160 is formed as a selectively expandable segment of body 100 with respect to a radial direction of body 100. According to one embodiment, mechanical treatment portion 160 comprises a mesh, stent or balloon. The selective expansion of body 100 enables mechanical treatment of a blood vessel by physically contacting the relevant obstruction(s) in the blood vessel and capturing, dispersing, or entangling the obstruction while also allowing for navigation of endovascular device 1 through a blood vessel. Mechanical treatment can also include reshaping of the blood vessel that can address blood flow issues not directly related to obstructions, such as narrowing of the blood vessels. Mechanical treatment can also include support of a blood vessel during treatment at a specific location, such as during treatment of an aneurysm, e.g. by coiling or insertion of other treatment material. For example, an expanded mechanical treatment portion 160 may contact a blood clot and either disperse it by mechanically rupturing the clot or may entangle the clot for removal by retracting body 100.

[0078] In these embodiments, mechanical treatment portion 160 is formed as a mesh of interlocking strands of material. This mesh may be formed from a variety of weaves and filaments of material, such as a 2x1 weave (where certain strands are more than one filament wound or braided together, and these multi-filament strands then are woven together), or a 2x2 weave (where all strands are formed from multiple filaments). Exemplary weaving patterns include 1x2, 2x1, 2x2, 2x3, 3x3. Example drawings of these meshes are shown in FIGS. 9-10.

[0079] Any number of total filaments may be used, for example, a plurality of wires between 6 and 16 separate wires (which may be multi-filament), e.g., 6-14 wires, 6-12 wires, 6-10 wires, 6-8 wires, 8-10 wires, 10-12 wires (such as e.g., 6, 7, 8, 9, 10, 11 or 12 wires), can be braided together. The junctions between each wire that form the mesh can be reinforced with suitable techniques (such as by mechanical connections like crimping or being woven together, welding, or adhesives). The mesh may further include twists of wires to prevent slippage of the wires (e.g. during mesh expansion and contraction). Moreover, windows of different sizes may be formed in the mesh, particularly during mesh expansion, these depend on the location of the opening within the mesh, and the degree of expansion of the mesh. The windows formed may function in clot capture or as filter/s to catch blood clots.

[0080] The plurality of wires comprised in mechanical treatment portion 160 may comprise wires of different material or of different diameter. Alternatively, the wires in a mechanical treatment portion 160 may comprise identical properties. According to one embodiment, at least one wire of the plurality of wires has a diameter between 40 microns and 200 microns. For example, the at least one wire can have a diameter that is at least one of 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns, or a range thereof. For example, at least one wire of the plurality of wires can have a diameter in a range between 50 microns and 75 microns.

[0081] The plurality of wires of mechanical treatment portion 160 may be constructed of any suitable flexible material known to those skilled in the art. Suitable flexible materials can include, but are not limited to, polymers, metals, metal alloys, and combinations therefore. In some embodiments, for example, the wires may be constructed from super elastic metals such as Nitinol. In order to visualize the mechanical treatment portion 160 with angiographic imaging, the wires may further include a radio-opaque marker and/or material. For example, in an embodiment, mechanical treatment portion 160 may include a plurality of Nitinol wires with a core made of Tantalum or Platinum metals. The radiopaque core can be 20% to 50% by volume (e.g. 30% or 40%). In an additional embodiment, the wires can be made to be radiopaque by deposition of a thin layer of radiopaque metal such as Platinum. In some embodiments, such radiopaque features may be positioned at the proximal and distal ends of mechanical treatment portion 160, as discussed below.

[0082] Other suitable constructions of mechanical treatment portions 160 include those disclosed by U.S. Patent No. 11,083,473 and U.S. Patent Publication No. 2021/0161547, which are incorporated herein by reference in their entirety.

[0083] In some embodiments, the mesh may be cut from suitable material instead of braided together. The open nature of the mesh enables mechanical treatment because it allows fluid to pass through the mesh, while solid obstructions such as blood clots are captured by the mesh.

[0084] The proximal end 161 and distal end 162 of mechanical treatment portion 160 can be marked with markers 163 that are radiopaque. This allows for use of imaging techniques to determine the precise position of mechanical treatment portion 160 inside the blood vessel. In some embodiments, markers 163 also act as the connection points between mechanical treatment portion 160 and selectively bendable portion 110 and proximal portion 170. Any suitable connection type may be used, including mechanical connections, welding, or adhesives.

[0085] As seen in FIGS. 2-3, the mesh form of mechanical treatment portion 160 can be closed at both ends because the filaments and wires all terminate at markers 163. However, in some embodiments, mechanical treatment portion 160 may be formed as a mesh that is open at distal end 162 (the wires do not terminate at the corresponding distal marker 163). According to one embodiment, and as mentioned above, mechanical treatment portion 160 may be woven from wires (or at least some of the wires) that are continuum of wires that form proximal portion 170. Additionally, or alternatively, selectively bendable portion 110 may comprise at least some of the wires that are part of mechanical treatment portion 160. [0086] As shown in FIG. 3, activation tube 180 is used to contain and protect mechanical treatment portion 160 as endovascular device 1 is advanced through the body to the treatment site. Activation tube 180 can slide towards proximal end 3 of endovascular device 1 to expose mechanical treatment portion 160 for deployment (as shown by the arrows in FIG. 2). In this way, a small, smooth outer diameter of mechanical treatment portion 160 is presented when endovascular device 1 is navigating to the treatment site, which is beneficial for quick application of treatment. Activation tube 180 may be made of any suitable material, including for example metals such as a metal alloy, stainless steel or a polymeric material (e.g., polyethylene block amide), or a combination thereof. In some embodiments, activation tube 180 can include openings that are similar to openings 102 discussed above with respect to body 100. The discussion above with respect to the variations of openings 102 applies equally to any openings on activation tube 180. Openings in activation tube 180 can perform the same flexibility altering function as openings 102 perform for body 100.

[0087] Deployment of mechanical treatment portion 160 involves the expansion of mechanical treatment portion 160. This can be accomplished by different mechanisms. For example, in some embodiments control element 120 can be used to expand mechanical treatment portion 160. This can be accomplished by moving control element 120 proximally. As discussed above, control element 120 may be fixed to a portion of selectively bendable portion 110 that is located distally with respect to mechanical treatment portion 160. In these embodiments, the stiffness of mechanical treatment portion 160 is engineered to be less than that of selectively bendable portion 110 and proximal portion 170 with activation tube 180 retracted proximally and providing no support. Thus, when control element 120 is moved proximally, mechanical treatment portion 160 will experience an axial force in the proximal direction, which causes mechanical treatment portion 160 to collapse in axial length. This proximal motion therefore deploys the mesh of mechanical treatment portion 160. In these embodiments, the resulting axial contraction of body 100 (in mechanical treatment portion 160) will result in a straightening of selectively bendable portion 110 because of the reduction of tension on control element 120. The support provided by extended activation tube 180 (i.e., when mechanical treatment portion 160 is covered) ensures that only selectively bendable portion 110 is bent by control element 120 during navigation through the blood vessel to the target treatment site. Advancement of mechanical treatment portion 160 back into its travel configuration (shown in FIG. 3) is accomplished by reversing these steps.

[0088] An additional or alternative technique for controlling mechanical treatment portion 160 is the use of a separate control element 120 fixed to mechanical treatment portion 160. Movement of this control element 120 deploys and retracts mechanical treatment portion 160 by providing axial compression or tension as needed. The independent movement of this second control element 120 can be accomplished by actuation control 200 as discussed above. These embodiments have some benefits, for example, the benefit of providing a separate, dedicated control for mechanical treatment portion 160. It should be understood that this duplication of control element 120 can be accomplished as many times as needed in embodiments of body 100 with multiple selectively bendable portions 120 and mechanical treatment portions 160. According to one embodiment, control element 120 actuates mechanical treatment portion 160, while activation tube 180 or proximal portion 170 is used to actuate selectively bendable section 110.

[0089] An additional or alternative technique is the use of a self-expanding mesh as mechanical treatment portion 160. Self-expanding meshes are configured to have a natural resting state that is expanded when unsheathed. The retraction of activation tube 180 can therefore serve to deploy the mesh alone, without any need for additional inputs from control element 120. In some embodiments, both of these techniques can be combined. In these embodiments, only portions of mechanical treatment portion 160 may comprise selfexpanding mesh, with other portions of the mesh being non-expanding as discussed above. [0090] Proximal portion 170 functions to deliver selectively bendable portion 110 and mechanical treatment portion 160 to the appropriate treatment site in a blood vessel. Proximal portion 170 can therefore take any suitable form that can pass through a blood vessel and provide the needed support. Thus, proximal portion 170 can be a tube, shaft, wire, or other structure. In some embodiments, proximal portion 170 is formed as a hollow tube with or without openings 102 as discussed above. Proximal portion 170 must accommodate control element 120 that passes through selectively bendable portion 110 and/or through mechanical treatment portion 160. Thus, according to some embodiments, proximal portion 170 is hollow to allow control element 120 to travel therein. Other embodiments of proximal portion 170 are not hollow, but are directly connected to control element 120 at the junction between proximal portion 170 and mechanical treatment portion 160. According to some embodiments, proximal portion 170 of body 100 may also comprise a plurality of wires twisted to form a second cable, as discussed above.

[0091] Body 100 and activation tube 180 may be sized and configured to act with other endovascular devices, such as catheters, e.g., micro-catheters, or guide catheters or aspiration catheters. For example, as shown in FIGS. 2-3, a micro-catheter 190 may be advanced along the outside of body 100 to assist in treatment. The same type of nesting may allow for multiple other devices to be arranged around body 100. In some embodiments, there may be multiple additional devices. For example, in an embodiment similar to FIG. 3, there may be an additional guide catheter surrounding micro-catheter 190. This nesting of devices may be desirable to provide additional support to body 100 and to improve navigation of the combined endovascular devices.

[0092] In some embodiments, body 100 may include multiple selectively bendable portions 110, mechanical treatment portions 160, and proximal portions 170. These can be arranged in any suitable order. For example, the order discussed above may be repeated to provide multiple mechanical treatment portions 160 with a corresponding distally-adjacent selectively bendable portion 110. In other embodiments there may be different orders or combinations of the various segments. The length of the various segments may be varied as desired to accommodate specific design constraints. There may be additional activation tubes 180 associated with each additional mechanical treatment portion 160. These embodiments have additional benefits including providing multiple mechanical treatment areas and multiple selectively bendable portions, which improve treatment options and device flexibility and control for navigation.

[0093] According to one embodiment, selectively bendable portion 110, mechanical treatment portion 160 and proximal portion 170 may be fabricated as a single unitary structure. Note that in FIGS. 2-3 the outer diameter of the selectively bendable portion 110 can be different than the outer diameter of activation tube 180. In some embodiments, the outer diameter of the selectively bendable portion 110 can be greater than the outer diameter of activation tube 180. In some embodiments, the outer diameter of the selectively bendable portion 110 can be less than the diameter of activation tube 180. Alternatively, the outer diameter of the selectively bendable portion 110 can be equal to the outer diameter of activation tube 180. [0094] In some embodiments, at least some of body 100 may be coated with various substances to improve system performance. For example, an exterior surface of body 100 intended for insertion into a patient may be entirely or partially equipped with an elastic or otherwise compliant, biocompatible coating or sheath to provide a smooth outer surface hydrophobic or hydrophilic, depending on the needs and circumstances. A coating material is selected to minimize sliding friction of the device during insertion and removal into a subject’s body, and is substantially chemically inert in the in vivo vascular environment. According to one embodiment, the exterior surface of tube 100 may have a hydrophilic coating to reduce friction between body 100 and a blood vessel. Examples of suitable coatings include, but are not limited to, polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), urethane, polyurethane, thermoplastic polyurethanes (TPU), silicone Polyether block amide (PeBax), Nylon or polyethylene (PE), other polymers, polyurethane polymers, and elastomers are also suitable for coating. Additionally or alternatively, the coating material may be selected for its hydrophilic properties thus improving gliding in blood and navigability. Typically, this kind of coating is applied at the distal end 2 of body 100 and extends up to 50-500 cm from the tip, e.g., 50 cm, 100 cm, 150 cm, 200 cm from the tip. Suitable coatings can be formed by any method known in the art, such as by dipping, spraying or wrapping and heat curing operations.

[0095] The integration of bearings 218 into an endovascular device handle will be discussed with respect to FIGS. 11-15. An example actuation control 200 will be discussed below to provide context for the integration of bearings 218 into an endovascular device handle. However, it should be understood that bearings 218 can be applied to any handle for an endovascular device where at least one portion of the endovascular device is fixed with respect to a portion of the handle. A skilled artisan would understand that the techniques discussed below for integrating bearings 218 into a handle can be applied to any type of mounting between a handle and an endovascular device. It should be understood that the term “actuation control” may also be described as a “handle” and, thus, these terms can be used interchangeably. Accordingly, the actuation control described herein may not necessarily comprise a handle-held device and may include an actuation control which can be placed on any surface.

[0096] While the embodiments of actuation control 200 shown in FIGS. 11-15 include bearings 218, it should be understood that other embodiments of actuation control 200 do not include any bearings 218. In some of these embodiments the rotatable portions of actuation control 200 that include bearings 218 can be replaced by fixed connections between the relevant components. In other embodiments the relevant portions may still be rotatable, but may not include bearings 218. Details regarding this construction will be discussed below.

[0097] As shown in FIGS. 11-15, in an embodiment actuation control 200 formed from a housing 201. According to one embodiment, housing 201 is shaped to be comfortably grasped by a user. According to another embodiment, housing 201 is shaped to be comfortably placed on a bed-side table or by a patient during a medical procedure. Housing 201 can be formed in any suitable shape, such as but not limited to, prismatic, cylindrical, oval, rectangular, square, hexagonal, tubular, trapezoidal, or round shape, or any combination thereof, and can be tapered or non-tapered. For example, as seen in FIG. 11, housing 201 can be shaped as a rectangular prism. Other suitable shapes of housing 201 can include other prismatic shapes or irregular shapes configured to maximize user grip or usability. Housing 201 can be formed from any suitable material, such as but not limited to, plastics (e.g., thermoplastic such as polycarbonate, polypropylene or polyethylene), silicones, composite materials, metal materials (e.g., stainless steel, nickel alloys, titanium, titanium alloys, or combinations thereof), or combinations thereof. In some embodiments, housing 201 may include materials or material treatments on its exterior that improve grip or placement on a surface, such as inlays or portions of rubber or other non-skid materials and coatings such as non-slip coatings. Housing 201 can have a smooth surface or an uneven surface. Housing 201 is intended to be handled by a user, and thus is preferably designed to be lightweight.

[0098] Housing 201 is fixed at or adjacent to proximal end 3 of endovascular device 1. As will be explained below, various elements of endovascular device 1 enter into housing 201 and are manipulated by elements inside of housing 201. In this way, a user can grip housing 201, or may place it on a surface, and manipulate the various actuatable portions of endovascular device 1. As mentioned above, endovascular device 1 itself is fixed to housing 201, and thus movement of housing 201 results in movement of endovascular device 1. Thus, movement of housing 201 is typically used to navigate the entirety of endovascular device 1 during the procedure. [0099] In some embodiments, housing 201 may have a cover 202 that is removable from housing 201. FIGs. 12 and 14 show housing 201 with cover 202 removed. Cover 202 may be fixed to housing 201 in any suitable removable fashion, such as with, but not limited to, with mechanical fasteners, e.g., screws, nails, nuts, bolts, washers, anchors and rivets. In other embodiments, cover 202 is permanently fixed to housing 201 during manufacturing of actuation control 200 by any suitable technique, such as but not limited to, with adhesives, welding, or integral mechanical features, such as snap features.

[0100] As shown in FIGS. 11-14, activation tube 180 is visible entering the interior of housing 201 from the left side of these figures. Also shown in FIG. 11 are buttons 210 and 212, which are positioned on an exterior of housing 201. Buttons 210 and 212 are positioned to receive input from the user to control the actuation of selectively bendable portion 110. Buttons 210 and 212 can be positioned anywhere on the exterior of housing 201. According to one embodiment, buttons 210 and 212 can be positioned such that they are grouped together in a convenient location for actuation by the user’s fingers. As shown in FIG. 11, buttons 210 and 212 can include markings to indicate which function is controlled by depressing buttons 210 and 212. These markings can include, for example, lettering or graphical icons. In FIG. 11, button 210 includes a “J” shape and is intended to command an increased curvature of selectively bendable portion 110. Button 212 includes an “I” shape and is intended to command a decreased curvature or straightening of selectively bendable portion 110. Buttons 210 and 212 may also include separate colors and/or textures that correspond to the functionality commanded by depressing the buttons.

[0101] Also seen in FIG. 11 is a slider 230. Slider 230 is positioned on an exterior of housing 201 and actuates one of the controllable elements of endovascular device 1. In some embodiments, slider 230 is mounted to slide in the direction of the longitudinal axis of housing 201. Slider 230 is typically shaped to be actuatable by a finger or thumb of a user. In some embodiments, slider 230 may have an embedded texture or structure to improve the ability of the user to move slider 230. Like buttons 210 and 212, slider 230 may also include markings, lettering, or coloring that indicates the function controlled by slider 230.

[0102] FIGs. 12 and 14 show a view of the interior of housing 201 (with cover 202 removed). An actuator 214 is placed in housing 201 and is configured to actuate an element of endovascular device 1. Actuator 214 produces force and/or displacement, in a controlled way, when an electrical input is supplied to it. An actuator converts such an input signal into the required form of mechanical energy. Specifically, actuator 214 is intended to actuate control element 120 by extending or retracting control element 120 in the longitudinal direction. Actuator 214 can be any suitable electronic linear actuator. As seen in FIGS. 12 and 14, actuator 214 is oriented such that its axis of extension or retraction is aligned with the longitudinal direction.

[0103] Also seen in FIGs. 12 and 14, control element 120 extends to actuator linkage 219. Actuator linkage 219 is a structure that links control element 120 to actuator 214. As seen in FIG. 12, actuator linkage 219 extends in a direction perpendicular to the longitudinal direction. This allows control element 120 of endovascular device 1, to extend into housing 201 in the longitudinal direction parallel to actuator 214 but offset from actuator 214. This arrangement reduces the overall length of housing 201 in the longitudinal direction, making it easier to manipulate housing 201 (e.g., by hand).

[0104] Actuator linkage 219 is fixed to a portion of actuator 214 and a portion of control element 120 such that movement of control element 120 is synchronized with movement of the movable portion of actuator 214 in the longitudinal direction. Actuator linkage 219 can be rigidly fixed to actuator 214 by any suitable method, such as but not limited to, adhesives, a press fit, or welding. However, in some embodiments control element 120 is typically free to rotate about the longitudinal direction within its connection to actuator linkage 219. This can be accomplished by, for example, passing control element 120 through an opening in actuator linkage 219 and securing control element 120 on either side of actuator linkage through suitable fixed elements that allow for rotation relative to actuator linkage 219, such as for example, by washers or similar elements fixed to control element 120. The opening in actuator linkage 219 can include one or more suitable rotating elements, such as one or more bearings 218, to reduce friction between control element 120 and actuator linkage 219. Bearings 218 may include, for example, 1, 2, 3, 4, 5, 6 or more rotating elements (e.g., 1 or 2 bearings) at the connection of control element 120 and actuator linkage 219. Suitable bearings include for example, but not limited to, bushings, ball bearings, or roller bearings, needle bearings, thrust bearings, spherical bearings, plain bearings, or any combination thereof. Other techniques can be used to enable rotation between control element 120 and actuator linkage 219. For example, control element 120 can be at least partially formed with a cylindrical outer surface, and that outer surface can be passed through the corresponding opening in actuator linkage 219 and fixed as discussed above. This will enable rotation without a bearing 218. In other embodiments control element may be fixed to actuator linkage 219 and not be able to rotate, such as by a mechanical press fitting or other similar techniques.

[0105] Also shown in FIGs. 12 and 14 are button circuits 210a and 212a. Each of button circuits 210a and 212a corresponds to one of buttons 210 and 212, respectively. Button circuits 210a and 212a translate the mechanical actuation (depression) of buttons 210 and 212 into an electrical signal via a suitable sensor, such as a switch. This signal is then used to control actuator 214. In some embodiments, the relevant control circuitry is analog in nature, whereby the mechanical depression of one of buttons 210 and 212 directly or indirectly activates a relay or other circuitry component that provides power to actuator 214. The circuitry is designed to activate actuator 214 in both directions, with each direction being assigned to one of buttons 210 and 212. In other embodiments, there may be one or more controller integrated into or operably connected to button circuits 210a and 212a. The controller may have a suitable processor and memory to control various components of actuation control 200. The controller receives the signals from buttons 210 and 212 as an input and controls actuator 214 accordingly. In some embodiments, a single controller is utilized. In other embodiments, two or more controller elements are utilized. In some embodiments, the controller is physically separated from actuation control 200 and is in wireless or wired communication with the relevant components to effect the operations discussed here. In any embodiment, a power source may be integrated into actuator 214. Any suitable power source may be used. For example, the power source may be a battery to provide power for operation of actuator 214. In this way, actuation control 200 does not need to be connected to a separate power source during operation.

[0106] FIGS. 12 and 14 also show details related to the interface between components of endovascular device 1 and housing 201. The outermost portion of endovascular device 1, typically enters housing 201 from the left-hand side of these figures. As previously discussed, activation tube 180 is typically the outermost portion of endovascular device 1, and hence, typically enters housing 201 from the left-hand side of these figures. According to an alternative embodiment, micro-catheter 190 may surround activation tube 180 and may thus be the outermost portion of endovascular device 1, and hence, micro-catheter 190 enters housing 201 from the left-hand side of these figures. One or more bearings 218 may be disposed in housing 201 at or near the entry point of endovascular device 1 into housing 201. Bearings 218 may include, for example, 1, 2, 3, 4, 5, 6 or more rotating elements (e.g., 1 or 2 bearings) at the connection of endovascular device 1 and housing 201. Such determinations are within the knowledge of one of skill in the art. These bearings 218 optionally allow for rotation of endovascular device 1 about the longitudinal direction independent from rotation of actuation control 200. As was explained above with respect to actuator linkage 219 and will be explained further below, each link between endovascular device 1 and actuation control 200 allows for rotation via bearings 218. This provides benefits during navigation of endovascular device 1 because it allows a user to keep actuation control 200 in a single orientation while rotating endovascular device 1 during navigation. In some examples, but without being limited to, bearings 218 may include bushings, ball bearings, roller bearings, needle bearings, thrust bearings, spherical bearings, plain bearings, or any combination thereof.

[0107] In an alternative embodiment, the outermost portion of endovascular device 1, such as micro-catheter 190, is connected to housing 201 from outside of the housing and does not enter housing 201. According to an embodiment, and as discussed above, one or more bearings 218 may be disposed near the entry point of endovascular device 1 into housing 201 to allow for rotation of endovascular device 1 about the longitudinal direction independent from rotation of actuation control 200. Bearings 218 may include, for example, 1, 2, 3, 4, 5, 6 or more rotating elements (e.g., 1 or 2 bearings) at the connection of endovascular device 1 and housing 201. The discussion above regarding non-bearing rotating connections and fixed connections applies equally to the connection between micro-catheter 190 and housing 201.

[0108] As seen in FIGS. 12 and 14, slider 230 extends into housing 201 via slider linkage 232. Slider linkage 232 has two primary functions. First, slider linkage 232 is slidably mounted to the exterior of a guide tube 233. Guide tube 233 is fixed to the interior of housing 201 and oriented longitudinally such that it is aligned with endovascular device 1. Guide tube 233 provides a track for slider linkage 232 to slide along, and, in turn, allows slider 230 to slide back and forth along housing 201. Guide tube 233 is also hollow and open along the portion of guide tube 233 closest to slider 230. This allows a portion slider linkage 232 to enter guide tube 233 and connect to the end of activation tube 180, which enters into the interior of guide tube 233. Thus, the second function of slider linkage 232 is to connect slider 230 to activation tube 180, which is contained by guide tube 233. In this way, movement of slider 230 longitudinally moves activation tube 180 longitudinally via slider linkage 232. As discussed above with respect to actuator linkage 219, the linkage between slider linkage 232 and activation tube 180 fixes activation tube 180 to slider linkage 232 with respect to the longitudinal direction, but optionally allows for rotation of activation tube 180 about the longitudinal axis with respect to slider linkage 232. The same techniques discussed above with respect to actuator linkage 219 can be used for this connection. Specifically, this can be accomplished by placing one or more bearings 218 (e.g., 1, 2, 3, 4, 5, 6 or more bearings) in an opening in slider linkage 232. Activation tube 180 is passed through the opening and bearings 218 and is fixed on either side of slider linkage 232 in the longitudinal direction, leaving activation tube 180 free to rotate in slider linkage 232.

[0109] Also seen in FIGS. 11 A, 12, and 14 is an activation button 236. In some embodiments, activation button 236 is positioned on an exterior of housing 201 such that it is shielded or covered by slider 230 when slider 230 is in a first position. In the case of FIGS. 12 and 14, slider 230 covers activation button 236 when slider 230 is at a position closest to endovascular device 1. As seen in FIG. 11 A, moving slider 230 to a second position (e.g., a position further from endovascular device 1) uncovers activation button 236 and allows a user to depress activation button 236. In other embodiments, activation button 236 can be located in any other suitable location on housing 201.

[0110] Activation button 236 functions to receive an input from the user to command actuation control 200 to activate a function of endovascular device 1. For example, in some embodiments, the relevant function is the operation of mechanical treatment portion 160. For example, activation button 236 may function to command expansion or retraction (e.g., contraction) of a mesh of mechanical treatment 160. Depression of activation button 236 by a user sends a signal to a controller. The controller can then determine what action is necessary to command the required function. In the example of expanding or retracting the mesh, the controller can determine whether actuator 214 needs to add tension to control element 120 by extending to the right in FIG. 12 based on the known position of actuator 214. The controller can also command actuator 214 to retract or move leftwards in FIG. 12 to release tension on control element 120 to retract the mesh. Determining whether an expansion or retraction of the mesh is needed can be based on an alternating count of depressions of activation button 236. That is, according to one embodiment, after initial powering of actuation control 200, the first depression of activation button 236 results in expansion of the mesh, the second depression of activation button 236 results in retraction of the mesh, and so on. This same logic can apply to different embodiments of mechanical treatment portion 160.

[OHl] In some embodiments, activation button 236 comprises two or more buttons, such that each button comprises a different functionality. For example, a first activation button 236 may function to command expansion of a mesh of mechanical treatment 160, while a second activation button 236 may function to command retraction (e.g., contraction) of a mesh of mechanical treatment 160. When more than one activation button 236 is utilized, these can be positioned such that they are grouped together in a convenient location for actuation by the user’s fingers. If more than one activation button 236 is utilized, these can include markings to indicate which function is controlled by depressing each of the buttons. These markings can include, for example, lettering, graphical icons, separate colors and/or textures that correspond to the functionality commanded by depressing each of the buttons. [0112] Determining whether an expansion or retraction of the mesh is needed can be based on one or more sensors 237 that detect the position of slider 230. Sensors 237 can be any suitable sensor, such as, but not limited to, a hall effect sensor or micro switch sensor. For example, sensor 237 may be a single hall-effect sensor placed at the right-most end of slider 230’s travel path as shown in FIG. 12. This allows sensor 237 to detect when slider 230 is in the fully deployed position. Another sensor 237 can be placed at the opposite end (leftmost) of slider 230’s travel path to detect when slider 230 is in the fully retracted position. According to some embodiments, buttons 210 and 212 may also function to control mechanical treatment portion 160 (e.g., after the activation tube has been unsheathed). Accordingly, buttons 210 and 212 may receive input from the user to control the expansion or retraction (e.g., contraction) of a mesh embodiment of mechanical treatment 160 (e.g., after the activation tube has been unsheathed). Other embodiments of mechanical treatment portion 160 can be controlled in the same manner as discussed here.

[0113] Extending through guide tube 233 and beyond slider linkage 232 is body 100 of endovascular device 1. Body 100 terminates at and is fixed longitudinally to housing 201 at body linkage 216. Like the other linkages above, body linkage 216 acts to fix body 100 longitudinally while optionally allowing body 100 to rotate about the longitudinal axis with respect to housing 201. In this case, the linkage is between housing 201 and body 100. The same technique with respect to bearings 218 can be used to create this linkage as discussed above. Namely, body 100 can pass through an opening of body linkage 216 and be fixed on either side of the opening. Body 100 may be free to rotate through the opening, which as can be seen in FIGS. 12 and 14, by including one or more bearings 218 (e.g., 1, 2, 3, 4, 5, 6 or more bearings). This allows movement of housing 201 longitudinally to translate into movement of body 100, facilitating navigation of endovascular device 1 by the user.

[0114] As seen in FIGS. 11 and 12, a torquer 203 is fixed to the outermost portion of endovascular device 1, which in these embodiments is activation tube 180, adjacent to but separate from actuation control 200. This torquer 203 allows the user to reach forward and rotate endovascular device 1, which allows for rotational control of endovascular device 1 independent of actuation control 200. Torquer 203 may be positioned at any suitable distance from actuation control 200.

[0115] FIG. 15 is a detail cross-section of the interface between actuator linkage 219 and control element 120. Here, a bearing 218 is placed inside the opening in actuator linkage 219. The outer portion of bearing 218 is fixed to the inside of the opening in actuator linkage 219. Control element 120 is then passed through bearing 218 and actuator linkage 219. The inner portion of bearing 218 contacts control element 120 and can rotate with respect to actuator linkage 219. Control element 120 is secured on either side of actuator linkage 219 through stops 226. Stops 226 are shown as circular washer-like elements that are fixed to control element 120 in FIG. 15. Because stops 226 are fixed to control element 120, control element 120 will move with actuator linkage 219 in the longitudinal direction (left to right in FIG. 15). Stops 226 can be formed, for example but not limited to, as disc-like washers, or can also be shaped as protrusions or other elements that are formed around control element 120. In some embodiments, there may not be any stops 226 present. Instead, control element 120 can be press fit or adhered into bearing 218. This fixing acts in place of stops 226. In FIG. 15 there is a gap shown for clarity between stops 226 and portions of bearing 218, but this gap may not be present according to some embodiments. Bearing 218 can be any suitable type of bearing, including, but not limited to, bushings, ball bearings, roller bearings, needle bearings, thrust bearings, spherical bearings, plain bearings, or any combination thereof. In this way, control element 120 is free to rotate about its axis but is secured to actuator linkage 219 in the longitudinal direction. [0116] As shown in FIG. 16, in an embodiment, a method of using actuation control 200 to operate an endovascular device 1 begins at a step 300 by receiving a longitudinal movement of housing 201 from the user to advance or retract endovascular device 1. This initial step 300 can also be accomplished by receiving a longitudinal movement of endovascular device 1 without use of housing 201 (e.g., the user moves endovascular device 1 separately). A step 302 includes receiving an input at button 210 or button 212 to adjust the orientation of selectively bendable portion 110. A step 304 includes extending or retracting the movable portion of actuator 214 to increase or reduce tension on control element 120 in accordance with the input received from the user to adjust the orientation of selectively bendable portion 110. A step 306 includes receiving an input of actuation of slider 230 to unsheathe activation tube 180. A step 308 includes receiving an input by activation button 236 to command mechanical treatment portion 160. At a step 310, a controller determines the movement of the movable portion of actuator 214 needed to command achieve the configuration of mechanical treatment portion 160 per the input received.

[0117] Advantages of the embodiments and methods discussed above include providing an actuation control 200 that can be used to command precise, repeatable manipulations of endovascular device 1 in a simple-to-use manner. Other embodiments of the disclosure provide advantages including readings of force applied to various subcomponents of endovascular device 1, which can be used to improve treatment efficiency and safeguard against problems created by excessive force application.

[0118] Exemplary embodiments of the invention are further provided below.

[0119] Example 1

[0120] In a first example, an actuation control for an endovascular device, comprises a housing; an actuator disposed in the housing; an actuator linkage fixed to a portion of the actuator in the housing and connecting the portion of the actuator to a first portion of an endovascular device that is disposed inside the housing; and a button disposed on an exterior of the housing and configured to command a first movement of the portion of the actuator.

[0121] Example 2

[0122] The actuation control of example 1, further comprising: a second button disposed on an exterior of the housing and configured to command a second movement of the portion of the actuator, wherein the second movement directs the portion of the housing to move in a direction different from the first movement.

[0123] Example 3

[0124] The actuation control of any of the above examples, wherein the actuator linkage fixes the first portion to the portion of the actuator in a longitudinal direction, but allows rotational movement of the first portion about the longitudinal direction with respect to the actuator linkage.

[0125] Example 4

[0126] The actuation control of any of the above examples, wherein the actuator linkage allows rotational movement of the first portion about the longitudinal direction with respect to the actuator linkage.

[0127] Example 5

[0128] The actuation control of any of the above examples, wherein the actuator linkage includes an opening that the first portion passes through, and wherein the opening includes a rotatable element for allowing the first portion to rotate with respect to the actuator linkage.

[0129] Example 6

[0130] The actuation control of any of the above examples, further comprising: a slider movably disposed on an exterior of the housing; and a slider linkage disposed inside the housing and connected to the slider, the slider linkage connecting the slider to a second portion of an endovascular device that is disposed inside the housing, wherein movement of the slider moves the second portion of the endovascular device.

[0131] Example 7

[0132] The actuation control of any of the above examples, wherein the slider linkage fixes the second portion to slider in a longitudinal direction.

[0133] Example 8

[0134] The actuation control of any of the above examples, wherein the slider linkage allows rotational movement of the second portion about the longitudinal direction with respect to the slider linkage.

[0135] Example 9

[0136] The actuation control of any of the above examples, wherein the slider linkage includes an opening that the second portion passes through, and wherein the opening includes a rotatable element for allowing the second portion to rotate with respect to the slider linkage.

[0137] Example 10

[0138] The actuation control of any of the above examples, further comprising: a guide tube disposed inside the housing and configured to receive at least the second portion of the endovascular device, wherein the slider linkage is slidably disposed around the guide tube.

[0139] Example 11

[0140] The actuation control of any of the above examples, further comprising a body linkage fixed to an interior of the housing, the body linkage connecting a third portion of the endovascular device to the interior of the housing.

[0141] Example 12

[0142] The actuation control of any of the above examples, wherein the body linkage fixes the third portion to the interior of the housing in a longitudinal direction.

[0143] Example 13

[0144] The actuation control of any of the above examples, wherein the body linkage but allows rotational movement of the third portion about the longitudinal direction with respect to the interior of the housing.

[0145] Example 14

[0146] The actuation control of any of the above examples, wherein the body linkage includes an opening that the third portion passes through, and wherein the opening includes a rotatable element for allowing the third portion to rotate with respect to the body linkage.

[0147] Example 15

[0148] The actuation control of any of the above example, further comprising: an activation button disposed on an exterior of the housing, the activation button configured to receiving an input from a user; and a controller disposed in the housing and operably connected to the activation button, the controller configured to command a deployment or retraction of a mechanical treatment portion of the endovascular device after receiving the input.

[0149] Example 16

[0150] The actuation control of any of the above examples, further comprising a controller disposed in the housing and operably connected to the button disposed on the exterior of the housing and configured to command the first movement of the portion of the actuator, the controller configured to command the movement of the portion of the actuator to control a selectively bendable portion or a mechanical treatment portion of the endovascular device after receiving the input.

[0151] Example 17

[0152] The actuation control of any of the above examples, further comprising a controller disposed in the housing and operably connected to the second button disposed on the exterior of the housing and configured to command the second movement of the portion of the actuator, the controller configured to command the movement of the portion of the actuator to control a selectively bendable portion or a mechanical treatment portion of the endovascular device after receiving the input.

[0153] Example 18

[0154] The actuation control of any of the above examples, wherein the first portion of the endovascular device and the actuator are disposed in the housing such that they each extend in a longitudinal direction parallel to and offset from each other.

[0155] Example 19

[0156] In another example a handle for an endovascular device comprises a housing configured to receive a portion of the endovascular device; a fixing structure in the housing configured to link the portion of the endovascular device to the handle; and a bearing disposed in and fixed to the fixing structure and configured to receive the portion of the endovascular device, the bearing configured to allow the portion of the endovascular device to rotate about an axis of the endovascular device with respect to the handle.

[0157] Example 20

[0158] The handle of any of the above examples, further comprising a stopper fixed to the portion of the endovascular device adjacent to the bearing, wherein the stopper is configured to prevent movement in a longitudinal direction of the portion of the endovascular device with respect to the bearing.

[0159] Example 21

[0160] The handle of any of the above examples, wherein the fixing structure is configured to move with respect to a portion of the handle.

[0161] Example 22

[0162] The handle of any of the above examples, wherein the portion of the endovascular device is fixed with respect to a portion of the bearing. [0163] Example 23

[0164] The handle of any of the above examples, further comprising a second fixing portion disposed in the housing configured to link a second portion of the endovascular device to the handle; and a second bearing disposed in and fixed to the second fixing structure and configured to receive the second portion of the endovascular device, the bearing configured to allow the second portion of the endovascular device to rotate about the axis of the endovascular device with respect to the handle.

[0165] Example 24

[0166] The handle of any of the above examples, wherein the second fixing portion is fixed with respect to a second portion of the handle.

[0167] Example 25

[0168] The handle of any of the above examples, further comprising a third fixing portion disposed in the housing configured to link a third portion of the endovascular device to the handle; and a third bearing disposed in and fixed to the third fixing structure and configured to receive the third portion of the endovascular device, the bearing configured to allow the third portion of the endovascular device to rotate about the axis of the endovascular device with respect to the handle.

[0169] Example 26

[0170] The handle of any of the above examples, wherein the third fixing portion is fixed with respect to a third portion of the handle.

[0171] Example 27

[0172] The handle of any of the above examples, wherein the bearing is selected from the group consisting of a roller bearing, a ball bearing, and a bushing.

[0173] Example 28

[0174] The handle of any of the above examples, wherein the bearing comprises at least one bearing.

[0175] Example 29

[0176] The handle of any of the above examples, wherein the second bearing is selected from the group consisting of a roller bearing, a ball bearing, and a bushing.

[0177] Example 30

[0178] The handle of any of the above examples, wherein the second bearing comprises at least one bearing. [0179] Example 31

[0180] The handle of any of the above examples, wherein the third bearing is selected from the group consisting of a roller bearing, a ball bearing, and a bushing.

[0181] Example 32

[0182] The handle of any of the above examples, wherein the third bearing comprises at least one bearing.

[0183] Example 33

[0184] The actuation control of any of the above examples, wherein the first portion of the endovascular device is a control element configured to control actuation of a selectively bendable portion.

[0185] Example 34

[0186] The actuation control of any of the above examples, wherein the second portion of the endovascular device is an activation tube configured to control a mechanical treatment portion.

[0187] Example 35

[0188] The actuation control of any of the above examples, wherein the third portion of the endovascular device is a body of the endovascular device.

[0189] Example 36

[0190] The actuation control of any of the above examples, wherein the fixing structure is configured to link the control element of the endovascular device to the actuation control.

[0191] Example 37

[0192] The actuation control of any of the above examples, wherein the second fixing structure is configured to link the activation tube of the endovascular device to the actuation control.

[0193] Example 38

[0194] The actuation control of any of the above examples, wherein the third fixing structure is configured to link the body of the endovascular device to the actuation control.

[0195] It is to be appreciated that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way. Moreover, the examples described above do not limit the present disclosure to what has been particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.

[0196] The use of the modifiers “approximately” or “about” in this disclosure are intended to indicate that the relevant element is subject to variation by a tolerance range. Unless otherwise defined, the use of these modifiers with respect to a unit of measure means a tolerance of plus or minus ten percent of the unit of measure. The use of these modifiers with respect to a description such as a shape is intended to allow for variations of that shape due to tolerance issues as would be understood to occur in the art in general.

[0197] The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

[0198] Various features of the invention which are, for clarity, described in the contexts of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment may also be provided separately or in any suitable subcombination.

[0199] 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

WHAT IS CLAIMED IS:

1. An actuation control for an endovascular device, comprising: a housing; an actuator disposed in the housing; an actuator linkage fixed to a portion of the actuator in the housing and connecting the portion of the actuator to a first portion of an endovascular device that is disposed inside the housing; and a button disposed on an exterior of the housing and configured to command a first movement of the portion of the actuator.

2. The actuation control of claim 1, further comprising: a second button disposed on an exterior of the housing and configured to command a second movement of the portion of the actuator, wherein the second movement directs the portion of the housing to move in a direction different from the first movement.

3. The actuation control of claims 1 or 2, wherein the actuator linkage fixes the first portion to the portion of the actuator in a longitudinal direction.

4. The actuation control of claim 3, wherein the actuator linkage allows rotational movement of the first portion about the longitudinal direction with respect to the actuator linkage.

5. The actuation control of claim 4, wherein the actuator linkage includes an opening that the first portion passes through, and wherein the opening includes a rotatable element for allowing the first portion to rotate with respect to the actuator linkage.

6. The actuation control of any one of claims 1-5, further comprising: a slider movably disposed on an exterior of the housing; and a slider linkage disposed inside the housing and connected to the slider, the slider linkage connecting the slider to a second portion of an endovascular device that is disposed inside the housing, wherein movement of the slider moves the second portion of the endovascular device.

7. The actuation control of claim 6, wherein the slider linkage fixes the second portion to slider in a longitudinal direction.

8. The actuation control of claim 7, wherein the slider linkage allows rotational movement of the second portion about the longitudinal direction with respect to the slider linkage.

9. The actuation control of claim 8, wherein the slider linkage includes an opening that the second portion passes through, and wherein the opening includes a rotatable element for allowing the second portion to rotate with respect to the slider linkage.

10. The actuation control of any one of claims 6-9, further comprising: a guide tube disposed inside the housing and configured to receive at least a section of the second portion of the endovascular device, wherein the slider linkage is slidably disposed around the guide tube.

11. The actuation control of any one of claims 1-10, further comprising a body linkage fixed to an interior of the housing, the body linkage connecting a third portion of the endovascular device to the interior of the housing.

12. The actuation control of claim 11, wherein the body linkage fixes the third portion to the interior of the housing in a longitudinal direction.

13. The actuation control of claim 12, wherein the body linkage allows rotational movement of the third portion about the longitudinal direction with respect to the interior of the housing.

14. The actuation control of claim 13, wherein the body linkage includes an opening that the third portion passes through, and wherein the opening includes a rotatable element for allowing the third portion to rotate with respect to the body linkage.

15. The actuation control of any one of claims 1-14, further comprising: an activation button disposed on an exterior of the housing, the activation button configured to receiving an input from a user; and a controller operably connected to the activation button, the controller configured to command a deployment or retraction of a mechanical treatment portion of the endovascular device after receiving the input.

16. The actuation control of any one of claims 1-15, further comprising a controller operably connected to the button disposed on the exterior of the housing and configured to command the first movement of the portion of the actuator, the controller configured to command the movement of the portion of the actuator to control a selectively bendable portion or a mechanical treatment portion of the endovascular device after receiving the input.

17. The actuation control of any one of claims 2-16, further comprising a controller operably connected to the second button disposed on the exterior of the housing and configured to command the second movement of the portion of the actuator, the controller configured to command the movement of the portion of the actuator to control a selectively bendable portion or a mechanical treatment portion of the endovascular device after receiving the input.

18. The actuation control of any one of claims 1-17, wherein the first portion of the endovascular device and the actuator are disposed in the housing such that they each extend in a longitudinal direction parallel to and offset from each other.

19. The actuation control of any one of claims 1-18, wherein the first portion of the endovascular device is a control element configured to control actuation of a selectively bendable portion.

20. The actuation control of claims 6-18, wherein the second portion of the endovascular device is an activation tube configured to control a mechanical treatment portion.

21. An actuation control for an endovascular device, comprising: a housing configured to receive a portion of the endovascular device; a fixing structure in the housing configured to link the portion of the endovascular device to the actuation control; and a bearing disposed in and fixed to the fixing structure and configured to receive the portion of the endovascular device, the bearing configured to allow the portion of the endovascular device to rotate about an axis of the endovascular device with respect to the actuation control.

22. The actuation control of claim 19, further comprising a stopper fixed to the portion of the endovascular device adjacent to the bearing, wherein the stopper is configured to prevent movement in a longitudinal direction of the portion of the endovascular device with respect to the bearing.

23. The actuation control of claim 19 or 20, wherein the fixing structure is configured to move with respect to a portion of the actuation control.

24. The actuation control of any one of claims 19-21, wherein the portion of the endovascular device is fixed with respect to a portion of the bearing.

25. The actuation control of any one of claims 19-22, further comprising a second fixing portion disposed in the housing configured to link a second portion of the endovascular device to the actuation control; and a second bearing disposed in and fixed to the second fixing structure and configured to receive the second portion of the endovascular device, the bearing configured to allow the second portion of the endovascular device to rotate about the axis of the endovascular device with respect to the actuation control.

26. The actuation control of claim 23, wherein the second fixing portion is fixed with respect to a second portion of the actuation control.

27. The actuation control of any one of claims 19-24, further comprising a third fixing structure disposed in the housing configured to link a third portion of the endovascular device to the actuation control; and a third bearing disposed in and fixed to the third fixing structure and configured to receive the third portion of the endovascular device, the bearing configured to allow the third portion of the endovascular device to rotate about the axis of the endovascular device with respect to the actuation control.

28. The actuation control of claim 25, wherein the third fixing structure is fixed with respect to a third portion of the actuation control.

29. The actuation control of any one of claims 19-26, wherein at least one of the bearing, the second bearing and the third bearing is selected from the group consisting of a roller bearing, a ball bearing, and a bushing.

30. The actuation control of any one of claims 11-18 and 25-26, wherein the third portion of the endovascular device is a body of the endovascular device.