Combined endovascular device and sheath for neurovascular procedures

Abstract

An endovascular device includes a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion. A tube is slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion and a proximal position of the tube where the tube is not covering the expandable portion. A distance traveled by the tube between the proximal position of the tube and the distal position of the tube is equal to a length of the mechanical treatment portion plus a predetermined distance.

Description

COMBINED ENDOVASCULAR DEVICE AND SHEATH FOR NEUROVASCULAR PROCEDURES CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims benefit to U.S. Provisional Application No. 63 / 721,920, filed November 18, 2024, which is incorporated herein in its entirety by reference thereto.BACKGROUND

[0002] This disclosure relates to the field of endovascular medical devices. Specifically, this disclosure is related to an endovascular device used for neurovascular procedures such as clot retrieval or stent retrieval.

[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. Application and / or removal of a stent can also be used to improve blood flow through a portion of a blood vessel. Stents are applied or removed using endovascular devices similar to those that treat blood clots.

[0005] Existing endovascular devices that use a mesh element are used in combination with a microcatheter, which is a hollow endovascular device that allows for passage of anotherendovascular device. The existing mesh-based devices are passed through the microcatheter, which acts to contain the mesh during navigation through the body. This requires manipulation of both the existing device and the microcatheter using both of the user’s hands, which increases operational complexity. The procedure also requires the placement of the microcatheter before insertion of the endovascular device, increasing operational steps and time required. Thus, there exists a need for simplified endovascular devices that employ a mesh.BRIEF SUMMARY

[0006] In an embodiment, an endovascular device includes a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion. A tube is slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion and a proximal position of the tube where the tube is not covering the expandable portion. A distance traveled by the tube between the proximal position of the tube and the distal position of the tube is equal to a length of the mechanical treatment portion plus a predetermined distance.

[0007] In an embodiment, an endovascular device includes a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion; a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion; and an actuation control configured to control movement of the tube and the expandable portion.

[0008] In an embodiment an endovascular device includes a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion; a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion; and a lock configured to lock the tube in the proximal position of the tube.

[0009] 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

[0010] 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.

[0011] FIG. 1 is a side cross-section view of an endovascular device according to an embodiment.

[0012] FIG. 2 is a side cross-section view of the endovascular device of FIG. 1 in an alternative configuration.

[0013] FIG. 3 is a side cross-section view of an endovascular device according to an embodiment.

[0014] FIG. 4 is a side cross-section view of the endovascular device of FIG. 3 in an alternative configuration.

[0015] FIG. 5 is a side cross-section view of an endovascular device according to an embodiment.

[0016] FIG. 6 is a side view of a handle of an endovascular device according to an embodiment.

[0017] 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

[0018] 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 necessarilyinclude 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.

[0019] Existing endovascular device with an expandable portion, such as a mesh or stent, require increased coordination because they must be paired with a microcatheter. The procedure typically requires the placement of the microcatheter before insertion of the endovascular device, increasing operational steps and time required. Embodiments of the present disclosure seek to address these issues by including an endovascular device having a flexible body with an expandable portion located near a distal tip of the body. A tube is slidably disposed around the body. The tube extends from adjacent to the expandable portion to near the proximal end of the device. The tube can be actuated by a user to slide over and enclose the expandable portion. This allows the endovascular device to be navigated to the treatment site without the need to manipulate a microcatheter at the same time. Operation is simplified by allowing single-handed use and by reducing the coordination required to navigate the mechanical treatment portion to the treatment site.

[0020] The tube can only slide a predetermined distance that allows for deployment of the expandable portion, which also simplifies operation and reduces potential mistakes. Some embodiments also include a lock that locks the tube in the proximal position, which is the position closest to the proximal end. This further simplifies operation because the tube can be actuated by the user to the locked position to deploy the expandable portion and then locked in place, preventing accidental movement of the tube. This lock and release process can be repeated as needed in order to enable multiple passes of the device for effective treatment at the treatment site. Additionally, or alternatively, some embodiments also include a device handle which can control movement of the tube (for example, to unsheathe or sheath the expandable portion) and which can control expansion or contraction of the expandable portion.

[0021] FIG. 1 shows an embodiment of an endovascular device 1 with 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 endof 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 1300 and 2500 millimeters (mm), e.g. between 1500 to 2000 mm, between 1800 to 2200 mm, or between 2000 to 2200 mm. In some embodiments, and as discussed below, endovascular device 1 comprises parts of different lengths.

[0022] In embodiments, a body 100 of endovascular device 1 is formed in a tubular shape with three main segments: a tip 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 tip 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 coil, a connector, a marker, or any other element suitable to be placed between portions of a tubular device may be used. For example, a marker may be placed at the distal end and / or at the proximal end of mechanical treatment portion 160. 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. In other embodiments, there may be multiple instances of each element discussed above in body 100. For example, there may be tip portion 110 followed by mechanical treatment portion 160, followed by a structure equivalent to tip portion 110, and then another mechanical treatment portion 160. In other embodiments, the three segments are formed as a single unitary structure without connections or attachments between tip portion 110, mechanical treatment portion 160 and proximal portion 170. In other embodiments, two of the segments are formed as a unitary structure without connections or attachments (e.g., tip portion 110 and mechanical treatment portion 160, or mechanical treatment portion 160 and proximal portion 170) and the third portion is attached thereto.

[0023] As seen in FIGS. 1-4, in some embodiments, body 100 can be formed as a cylinder with a central opening. 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 tip portion 110, mechanical treatment portion 160, and proximal portion 170, as well as any combinations thereof) are elastic and / or super-elastic polymers, superelastic 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), nickel -chromium alloy, nickelchromium-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, to act as a fluoroscopic marker to aid in visualization of the device in a blood vessel. According to a specific embodiment, tip 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.

[0024] 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 to provide a smooth outer surface that is hydrophobic or hydrophilic, depending on the needs and circumstances. A coating material can additionally or alternatively be selected to minimize sliding friction of the device during insertion and removal into a subject’s body, and can be 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. According to one embodiment, the exterior surface of tube 100 may have a hydrophilic coating that reduces friction between body 100 and tube 180. Examples of suitable coatings include, but are not limited to, polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), urethane, polyurethane, polyimide, 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 coatingmaterial 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 cm proximally, away from distal end 2. Suitable coatings can be formed by any method known in the art, such as by dipping, spraying or wrapping and heat curing operations.

[0025] 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 0.35 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.

[0026] In some embodiments, tip portion 110 may have the ability be shaped into a specific arrangement manually. This allows a user to bend to a desired curve or curves in tip portion 110 to improve navigation of endovascular device 1. The tip portion 110 may also pre-bend without user intervention or may not be bent at all. The material selection and structural design of tip portion 110 allows for this type of shaping. According to one embodiment, tip portion 110 comprises a shape-memory material. According to one embodiment, tip portion is configured to be bent into a predetermined shape. Exemplary shapes include, without being limited to, U-shape, J-shape, L-shape, I-shape, S-shape. According to one embodiment, tip portion 110 comprises the same material as other portions of body 100, such as proximal portion 170. In other embodiments, tip portion 110 may have the same flexibility as other portions of body 100, such as proximal portion 170. In some embodiments tip portion 110 may be fixed in a shape and be unbendable or otherwise be passive.

[0027] In embodiments as shown in FIGS. 1-4, a mechanical treatment portion 160 is formed as a selectively expandable segment of body 100 with respect to a radial directionof body 100. 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. 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. According to one embodiment, mechanical treatment portion 160 comprises a mesh, stent or balloon. In certain embodiments, mechanical treatment portion 160 is formed as a mesh of interlocking strands of material. It should be noted, that the same embodiments discussed for a mesh may be applied towards a stent. This mesh may be formed from a variety of weaves and filaments of material, such as a 2x1, 3x1 or 2x3 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 or 3x3 weave (where all strands are formed from multiple filaments). Any number of total filaments may be used, for example, between 6 and 12 separate wires (which may be multi-filament) 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). According to one embodiment, the mesh structure comprises a plurality of sets of looped wires, the plurality of sets of looped wires being spaced circumferentially about the mesh structure and being configured to cross each other at a plurality of intersection locations to form a clot capture structure, as discussed in detail in application nos. PCT / IB2016 / 001740 and PCT / IB2017 / 001487, incorporated herein by reference. 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.

[0028] As seen in FIGS. 1-4, the mesh form of mechanical treatment portion 160 can be closed at both ends because the filaments and wires all terminate together. However, in some embodiments, mechanical treatment portion 160 may be formed as a mesh that is open at one end (e.g., the end closest to distal end 2) because the wires of the mesh do not terminate together. According to one embodiment, mechanical treatment portion 160 maybe woven from wires (all of the wires, or at least some of the wires) that are continuum of wires that form proximal portion 170. Additionally, or alternatively, tip portion 110 may comprise at least some of the wires that are part of mechanical treatment portion 160.

[0029] As shown in FIGS. 1-4, a 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 or in close proximity to the treatment site. 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). Alternatively, tube 180 can slide distally to enclose mechanical treatment portion 160 (as see in FIG. 1.) 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.

[0030] 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. As tube 180 is intended to be at least partially inserted into a blood vessel, the material of tube 180 should be biocompatible. In some embodiments, the outside of tube 180 is designed for low friction to reduce friction between tube 180 and a blood vessel. In some embodiments, the inside of tube 180 is designed for low friction to reduce friction between tube 180 and body 100. According to one embodiment, the material of tube 180 provides strength and flexibility suitable for navigation in a blood vessel. For example, tube 180 may be constructed from various materials, including, but not limited to, an outer jacket constructed of Poly ether block amide (PEBAX), Polyurethane (TPU), Polyethylene (PE), Polyethylene terephthalate (PET) or Nylon (PA); and an inner liner constructed of Polytetrafluoroethylene (PTFE), Fluorinated ethylene propylene (FEP) or PEBAX. According to some embodiments, tube 180 may comprise a reinforcement (braid or coil) including, but not limited to, nitinol (a nickel -titanium alloy), stainless steel, tungsten, aramid, LCP (Liquid Crystal Polymer), or PEEK (Poly etheretherketone). In some embodiments, at least some of tube 180 may be coated with various substances to improve system performance. For example, an exterior surface of tube 180 intended for insertion into a patient may be entirely or partially equipped with an elastic or otherwise compliant, biocompatible coating to provide a smooth outer surface that is hydrophobic or hydrophilic, depending on the needs and circumstances. A coating material can additionally or alternatively be selected to minimize sliding friction of the device during insertion andremoval into a subject’s body, and can be substantially chemically inert in the in vivo vascular environment. Exemplary coating materials and methods of applying are provided hereinabove for body 100. According to some embodiments, tube 180 may include materials opaque to X-rays, such as platinum, gold, tungsten, tantalum or the like, to act as a fluoroscopic marker to aid in visualization of the device in a blood vessel.

[0031] In some embodiments, tube 180 is sized to pass through another, larger, catheter, such as a microcatheter, access catheter, or aspiration catheter. Body 100 is similarly sized. In some embodiments, the endovascular device 1 including tube 180 and body 100 is not designed to have enough torquability or stiffness to function without insertion into another catheter (e.g., an aspiration catheter or access catheter).

[0032] As shown in FIGS. 1-4 a control element 120 is disposed inside body 100 to control expansion and contraction of mechanical treatment portion 160, as will be explained below. Control element 120 extends from the proximal end 3 of body 100 to distal end 2 of body 100. According to one embodiment, control element 120 extends to tip 110. According to one embodiment, control element 120 extends to a distal end of mechanical treatment portion 160. 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. 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 mechanical treatment portion 160, and thus the portion of control element 120 that transitions through mechanical treatment portion 160 (if applicable) must be designed to allow for mechanical treatment portion 160 to expand and contrast 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.

[0033] According to an embodiment, an actuation control 200 is formed around part of proximal portion 170 closest to proximal end 3. Actuation control 200 functions to allow a user to control endovascular device 1, control element 120, and in some embodiments, tube 180. Actuation control 200 will be discussed in detail below.

[0034] In the embodiment of FIG. 1, actuation control 200 is formed with a housing 201.Body 100 is received by and fixed to housing 201 at least with respect to the linear directions (x, y, and z) to housing 201. In some embodiments, body 100 is free to rotate about its axis with respect to housing 201. In other embodiments body 100 is completely fixed, including rotationally, to housing 201. According to one embodiment, housing 201 is shaped to be gripped by the hand of a user. According to one embodiment, housing 201 is shaped to be placed on a surface.

[0035] In embodiments such as the one of FIGS. 1-2, housing 201 can include a first slider 202 (also referred to as ‘slider’) slidably mounted to housing 201. Housing 201 can also include a second slider 203 slidably mounted to housing 201, either alone or in combination with first slider 202. Both first slider 202 and second slider 203 are positioned on the exterior of housing 201 and are shaped to be actuated by a user, for example by a finger of a user. According to one embodiment, first slider 202 and second slider 203 are linearly positioned on the exterior of housing 201. According to one embodiment, first slider 202 and second slider 203 are positioned on the exterior of housing 201, but rotationally offset with respect to each other, as further discussed hereinbelow. First slider 202 extends into housing 201 and is physically linked to tube 180, which also extends into housing 201. Thus, movement of first slider 202 will produce corresponding movement of tube 180. This is shown in FIG. 2 by the arrows, which indicate first slider 202 having moved away from distal end 2 (towards the base of housing 201). The movement of first slider 202 results in axial movement (proximal or distal) of tube 180 and therefore in unsheathing / sheathing of mechanical treatment portion 160, as discussed in further detail below. Second slider 203 extends into housing 201 and is linked with control element 120. Movement of second slider 203 will therefore produce corresponding axial movement of control element 120. The movement of second slider 203 results in expansion / contraction of mechanical treatment portion 160, as further detailed below. The movement of both first slider 202 and second slider 203 can be constrained by the size of the opening in housing 201 that each slider is positioned in. This effectively adds a movement stop to endovascular device 1 inboth the proximal and distal directions. This is useful for first slider 202 because the movement of first slider 202 directly corresponds to movement of activation tube 180. In embodiments without actuation control 200 the movement stop or stops can be incorporated into body 100 or other suitable portions of endovascular device 1 as, for example, protrusions or other elements that restrict axial movement of tube 180. Thus, tailoring the opening, or positioning of the stops, to the right length controls the position and distance of movement of tube 180. In some embodiments, this positioning and distance can be set as needed to result in complete coverage of mechanical treatment portion 160 by tube 180 when first slider 202 is in the distal position and to exposure of mechanical treatment portion 160 by tube 180 when first slider 202 is in the proximal position.

[0036] In some embodiments, instead of a first slider 202 and / or of a second slider 203, actuation control 200 may include an actuator disposed in the housing that is coupled to tube 180 or to control element 120, respectively. One or more buttons or similar user input devices can be positioned on an exterior of housing 201 to allow a user to input commands to control the actuator, which in turn will slide tube 180 or control element 120 as desired. Thus, for example, some embodiments may include first slider 202 to control tube 180 while control element 120 is controlled by the actuator, eliminating second slider 203. The actuator or actuators can be mechanical, electrical, or combinations thereof. For example, one or more linear actuators may be used to control the linear motion associated with either or both of first slider 202 and second slider 203. Suitable electronic components such as batteries, processors, and other control circuitry can be incorporated to allow for operation of the actuator.

[0037] In some embodiments, instead of a first slider 202 and / or of a second slider 203, actuation control 200 may include a rotatable element disposed in the housing that is coupled to tube 180 or to control element 120, respectively. FIG. 6 show embodiments of actuator control 200, also referred to herein as handle 200. In these embodiments actuator control 200 is formed from three major components. First, a housing 201 serves as the base for actuator control 200. Second, a knob 220 is rotatably fixed to housing 201 such that knob 220 can be rotated about the axis of housing 201 by a user. Finally, a shaft 230 is disposed inside housing 201 and knob 220.

[0038] Operation of these embodiments of actuator control begins when a user grasps housing 201 in one hand and rotates knob 220 with respect housing 201 with either theirother hand or the same hand. In some embodiments the size and shape of actuator control 200 is selected to allow one hand operation. Rotation of knob 220 actuates shaft 230 along the longitudinal axis with respect to housing 201 and knob 220, with the direction of actuation either towards or away from distal end 211 depending on the direction of rotation of knob 220. This displacement of shaft 230 can then actuate tube 180 or control element 120, which is fixed to shaft 230, and achieve the effects discussed above. According to a specific embodiment, rotation of knob 220 followed by displacement of shaft 230 results in expansion and / or contraction of the expandable portion.

[0039] As shown in FIG. 6, housing 201 can be formed as an elongated, hollow structure having an interior space with an opening at distal end 211 that allows for access to the space. A proximal end 213 opposite distal end 211 can be closed. Proximal end 213 may comprise a partial opening, such as an indentation, which will receive one or more of the internal components as further discussed below. Housing 201 may take the form of any hollow shape. In some embodiments, housing 201 is approximately cylindrical in shape. Any other suitable hollow shape can be used. The exterior of housing 201 is configured to allow a user to grasp housing 201, and thus can have shapes and / or coatings that improve a user’s grip. Housing 201 can be made of any suitable material, including plastic, composite, or metal materials, or combination thereof.

[0040] Knob 220 is rotatably fixed to housing 201 at a position that is suitable for user access and allows for operation of first slider 202. In FIG. 6 knob 220 is positioned between distal end 211 and proximal end 213. Knob 220 cannot move with respect to housing 201 in the longitudinal direction or in any other linear direction. However, knob 220 can rotate with respect to housing 201. Knob 220 is formed with a passage through its longitudinal axis. Knob 220 has openings at both of its longitudinal ends that are the openings of the passage. Threads are formed within the inner walls of the passage through knob 220. A gripping portion 224 of knob 220 forms the majority of knob 220. Gripping portion 224 is configured to allow a user to grip knob 220 and can include shapes and / or coatings to improve grip by a user.

[0041] According to one embodiment, knob 220 is connected to housing 201 by a snap-fit type connection. This is accomplished by protrusions on a proximal end and / or distal end of knob 220 that are received in housing 201. Friction protrusions can be located on one or both of housing 201 and knob 220 and are designed to contact these elements to create adesired amount of friction and / or tactile sensations such as clicking when knob 220 is rotated. This improves the user experience by providing feedback and improving control of knob 220. Knob 220 can be made of any suitable material, including plastic, composite, or metal materials, or combination thereof.

[0042] As best shown in FIG. 6, shaft 230 is disposed inside of and in contact with housing 201 and knob 220. Shaft 230 is formed as an elongated body with openings at either longitudinal end. According to a specific embodiment, shaft 230 is a screw. Shaft 230 is rotationally fixed with respect to housing 201, but is able to translate in the longitudinal direction with respect to housing 201. Accordingly, shaft 230 comprises an element configured to prevent rotation of the shaft with respect to the body, and configured to allow the shaft to translate along the body in a longitudinal direction. According to one embodiment, this element comprises one or more tabs 232 that run longitudinally on housing 201. These tabs 232 fit into longitudinal grooves 218 formed inside housing 201. The dimensions of tabs 232 and grooves 218 are set to allow for free longitudinal sliding movement. The dimensions do not allow for rotation of shaft 230 because tabs 232 are captured by grooves 218. There can be any number tabs 232 and corresponding grooves 218. According to an exemplary embodiment, there may be 2-10 tabs, e.g., 3-8 tabs, spaced equally about shaft 230. In specific embodiments there are four tabs 232 spaced equally about shaft 230. Because of this arrangement shaft 230 can also translate longitudinally with respect to knob 220, and knob 220 can rotate with respect to shaft 230.

[0043] Shaft 230 of some embodiments further comprises a mechanism configured to convert rotational motion to linear motion, wherein rotation of the knob 220 rotates the shaft 230 to move in the longitudinal direction with respect to housing 201. According to one embodiment, the mechanism comprises threads 234 that are formed on the outside of shaft 230 (e.g., screw) in the portion of shaft 230 that is located inside knob 220. Threads 234 are captured by and mated with corresponding threads on the inside of knob 220. Rotation of knob 220 therefore causes the threads to rotate with respect to each other, which then moves shaft 230 longitudinally, either towards or away from housing 201. According to one embodiment, each of the threads is disposed partially around the circumference of the shaft. That is, each complete revolution of threads 234 about shaft 230 is interrupted or non-continuous in at least one location. In some embodiments, the interruption can be continuous feature, such as a flattened portion, that spans all of threads 234 at the samecircumferential location and that extends in a longitudinal direction. In other embodiments, the interruption can be located at different circumferential locations, and there can be more than one interruption in threads 234. In other embodiments threads 234 can be continuous and without interruption. The pitch of the threads can be set at any desired pitch. In some embodiments, the pitch can be set to allow for predetermined movement of shaft 230. The pitch, along with other dimensions, can also be set to prevent accidental movement by requiring a minimum force to actuate the threads. For example, one rotation of knob 220 can correspond to 1-6 millimeter of longitudinal movement of shaft 230. The direction of rotation of the threads can also be selected as desired to link one rotational direction to expand the expandable portion, while the other rotational direction contracts expandable portion. For example, a counterclockwise rotation of knob 220 when viewed from proximal end 213 may expand the expandable portion. It will be appreciated that in a different configuration a clockwise rotation of knob 220 when viewed from proximal end 213 may expand the expandable portion. Accordingly, a rotation of knob 220 in the other rotational direction will contract expandable portion. A stopper 236 can be fixed to the distal end of shaft 230. Stopper 236 is sized to stop longitudinal movement of stopper 236 through knob 220. This ensures shaft 230 is not actuated too far in the proximal direction. In some embodiments, a second stopper 236 can be placed on the proximal end of shaft 230 and can have the corresponding function of stopping distal movement. In other embodiments, one or both of stoppers 236 can be replaced by adjusting the length of grooves 218 such that the end of groove 218 acts as a stop when tabs 232 are moved into contact with the ends. Shaft 230 can be made of any suitable material, including plastic, composite, or metal materials, or any combination thereof. Tube 180 and / or control element 120 can be fixed to any suitable portion of shaft 230 using suitable means such as, for example, mechanical crimping and / or adhesives. In some embodiments, shaft 230 actuates body 100, while first slider 202 controls actuation of tube 180. In these embodiments, control element 120 passes through knob 220 and is fixed to an interior of housing 201 at proximal end 213. Actuation of body 100 creates the same effect as actuation of control element 120 because the relative position of control element 120 and body 100 are changed by rotation of knob 220.

[0044] Deployment of mechanical treatment portion 160 involves the expansion of mechanical treatment portion 160 after tube 180 has been moved proximally. This can be accomplished by different mechanisms. For example, in some embodiments, controlelement 120 that passes through body 100 can be used to expand mechanical treatment portion 160. This can be accomplished by moving control element 120 proximally using, for example, second slider 203. In these embodiments control element 120 will be fixed to mechanical treatment portion 160 (e.g., to a distal portion of mechanical treatment portion 160). The stiffness of mechanical treatment portion 160 is typically engineered to be less than that of tip portion 110 and proximal portion 170 with tube 180 retracted proximally and providing no support. Thus, when control element 120 is moved proximally, the distal part of 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 collapsing motion expands the mechanical treatment portion 160 (i.e., mesh, stent, or balloon) in the radial direction. Advancement of mechanical treatment portion 160 back into its travel configuration (shown in FIG. 3) is accomplished by reversing these steps. In short, when control element 120 is moved distally, the distal part of mechanical treatment portion 160 will experience an axial force in the distal direction, which causes mechanical treatment portion 160 (i.e., mesh, stent, or balloon) back into a natural resting state (also referred to as contracted state).

[0045] 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 (unconstrained by tube 180). The retraction of tube 180 can therefore serve to deploy and expand 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 self-expanding mesh, with other portions of the mesh being non-expanding as discussed above.

[0046] FIGS. 3-4 show an embodiment of endovascular device 1 with a modified actuation control 200. In this embodiment only second slider 203 is present and linked with control element 120 as described above. Housing 201 also is linked to body 100 as discussed above. However, tube 180 remains outside of housing 201. A grip 182 is fixed to an exterior of tube 180 near its proximal end and allows a user to grasp tube 180. Grip 182 is intended to be grasped by a user and allow a user to move tube 180. In this way, the user can manually slide tube 180 along body 100. The length of tube 180 is set such that a stop is formed when it contacts housing 201 in its most proximal position, where tube 180 will uncover or exposemechanical treatment portion 160 (as shown in FIG. 2). In this way the deployment of tube 180 is controlled similar to the movement of first slider 202 controlling tube 180 in the above embodiments. According to another embodiment, endovascular device 1 does not include any actuation control 200 or any handle. Accordingly, a stop is formed when grip 182 contacts a locking element, discussed below, in its most proximal position and thereby will uncover or expose mechanical treatment portion 160 as discussed above.

[0047] FIG. 3 is a schematic illustration of endovascular device 1 showing two features.First, a line 162 shows the total length of mechanical treatment portion 160, and a second line 184 shows the space between the proximal end of tube 180 when it is in its distal position (as in FIG. 3) and when the proximal end of tube 180 is in its proximal position. In some embodiments, line 162 and line 184 are the same distance. In other embodiments line 184 may be slightly longer than line 162 by a predetermined distance, for example by 1-50 millimeters (mm), e.g., by 5-50 mm, e.g., by 10-30 mm, e.g. by 10-20 mm. According to one embodiment, line 162 is in the range of about 10-100 mm, e.g., about 15-90 mm, e.g., about 20-75 mm, e.g., about 20-60 mm. According to a specific embodiment, line 184 may be slightly longer than line 162 by about e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40 or 50 mms, to allow for complete uncovering of mechanical treatment portion 160 with some margin. In some embodiments, the total length of displacement (line 184) shall be less than 2.5-20 cm, e.g. 2.5, 5, 7.5, 10, 12.5, 15, or 17.5 centimeters. Second, a lock 190 is shown. Lock 190 acts as a releasable lock for tube 180 when tube 180 is in the proximal position. Lock 190 can be any suitable locking mechanism. For example, in FIG. 3 lock 190 is a snap-fit type lock where a portion of tube 180 is received in snap-fit with a portion of actuation control 200. Other locking mechanisms can be used such as, but not limited to, a friction-fit type lock, a locking tab, or a magnetic-type lock. In some embodiments, lock 190 can be disposed on an exterior of actuation control 200 (for example, on the exterior of housing 201). In other embodiments, lock 190 can be disposed inside actuation control 200, for example inside housing 201. Lock 190 can be releasable by a user after engagement. By allowing the lock to be releasable, a user can, if required, reuse the same device for a second, third, fourth etc., pass until the obstruction has been cleared (e.g., until the entire clot is removed or narrowing of the blood vessel has been opened). In some embodiments, lock 190 is configured to produce an audible or tactile alert after locking, such as a clicking sound or similar vibration, to alert the user that the system is locked. Inembodiments with housing such as in FIGS. 1-4, the lock can be integrated into housing 201. In embodiments with sliders such as in FIGS. 1-2, the lock can be integrated into the slider. For example, detents can be used to releasably lock first slider 202 when first slider 202 is in the proximal position.

[0048] FIG. 5 shows an embodiment of actuation control 200 with second slider 203 positioned on an opposite side of housing 201 from first slider 202. This is accomplished by lengthening the linkage between second slider 203 and control element 120 to allow second slider 203 to be positioned as shown in FIG. 5. As shown in FIG. 5, second slider 203 can be positioned closer to distal end 2 as compared with other embodiments, such as the embodiment of FIGS. 1-4. In some embodiments, the sliders can be positioned at the same longitudinal position on housing 201 because of the rotational offset. This configuration can be beneficial because it allows housing 201 to be shorter longitudinally (along the axis of body 100), which can be beneficial to improve handling of housing 201 by a user. It should be understood that the position of the sliders is not limited to directly opposite (180 degree separation), but can include other rotational offsets, for example second slider 203 being positioned ninety degrees off from first slider 202. The linkage between second slider 203 can be modified as needed to accommodate the different rotational offset of the sliders.

[0049] When used with an aspiration catheter, a method of use of endovascular device 1 comprising a mesh includes the following steps. First, the aspiration catheter is delivered as close to the clot as possible. Second, endovascular device 1 (including tube 180 and body 100) is extended past the clot (through the aspiration catheter). Third, tube 180 is unsheathed to reach the locked proximal position. Fourth, the mesh is expanded / contracted to catch the clot (e.g., using a massage technique). Fifth, after the clot has been captured, the mesh is relaxed (e.g., to a neutral position to reduce the radial force on the vessel) and optionally retracted back into the aspiration catheter. And sixth, aspiration is activated for retrieval of the clot from the blood vessel. In case the clot has not been retrieved or not completely removed, additional passes may be carried out until the obstruction has been cleared. These same steps can be carried out with an access catheter instead of an aspiration catheter without the aspiration activation.

[0050] According to an embodiment, when used with an aspiration catheter to remove a blood clot, first, endovascular device 1 (including tube 180 and body 100) is delivered suchthat it extends past the clot. Second, tube 180 is unsheathed to reach the locked proximal position and to deploy the mechanical treatment portion 160 in proximity to the clot. Third, mechanical treatment portion 160 is expanded in a radial direction. Fourth, an aspiration catheter is delivered as close to the clot as possible. Fifth, the mesh is expanded / contracted to catch the clot (e.g., using a massage technique). Sixth, after the clot has been captured, the mesh is relaxed (e.g., to a neutral position to reduce the radial force on the vessel) and optionally retracted back into the aspiration catheter. And seventh, aspiration is activated for retrieval of the clot from the blood vessel. In case the clot has not been retrieved or not completely removed, additional passes may be carried out until the obstruction has been cleared. These same steps can be carried out with an access catheter instead of an aspiration catheter without the aspiration activation.

[0051] According to another aspect of the invention, there is provided a kit comprising endovascular device 1 including tube 180 and body 100 and an aspiration catheter. According to another aspect of the invention, there is provided a kit comprising endovascular device 1 including tube 180 and body 100 and an access catheter.

[0052] Advantages of the embodiments and methods discussed above include allowing for the rotation of endovascular device 1 with respect to the handle during navigation, which improves user control of the endovascular device.

[0053] Exemplary embodiments of the invention are further provided below.

[0054] Example 1

[0055] In a first example an endovascular device, comprises: a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion; and a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion, and wherein a distance traveled by the tube between the proximal position of the tube and the distal position of the tube is equal to a length of the mechanical treatment portion plus a predetermined distance.

[0056] Example 2

[0057] In a second example, an endovascular device, comprises: a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximalportion proximate to the mechanical treatment portion; a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion; and an actuation control configured to control movement of the tube and the expandable portion.

[0058] Example 3

[0059] In a third example, an endovascular device, comprises: a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion; a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion; and a lock configured to lock the tube in the proximal position of the tube.

[0060] Example 4

[0061] The endovascular device of any of the above examples, further comprising an actuation control configured to control movement of at least one of the tube and the expandable portion.

[0062] Example 5

[0063] The endovascular device of any of the above examples, wherein the actuation control comprises: a housing; and a slider slidably disposed on an exterior of the housing, wherein the tube extends into the housing and is coupled to a portion of the slider extending into the housing such that movement of the slider slides the tube along the body in an axial direction.

[0064] Example 6

[0065] The endovascular device of any of the above examples, further comprising a stop disposed in the housing and positioned to block the slider from sliding proximally beyond a proximal position of the slider that corresponds to the proximal position of the tube.

[0066] Example 7

[0067] The endovascular device of any of the above examples, further comprising a stop disposed in the housing and positioned to block the slider from sliding distally beyond a distal position of the slider that corresponds to the distal position of the tube.

[0068] Example 8

[0069] The endovascular device of any of the above examples, wherein an exterior of the actuation control is configured to act as a stop that contacts a proximal end of the tube and stops the tube from sliding proximally beyond a proximal position of the tube.

[0070] Example 9

[0071] The endovascular device of any of the above examples, wherein the tube comprises a grip disposed on an exterior of the tube, the grip positioned to allow a user to slide the tube along the body.

[0072] Example 10

[0073] The endovascular device of any of the above examples, further comprising a lock configured to lock the tube in the proximal position of the tube.

[0074] Example 11

[0075] The endovascular device of any of the above examples, wherein the lock comprises:a lock proximal portion located at the proximal end of the tube; and a lock distal portion coupled to one of a distal portion of an exterior of an actuation control housing or to a portion of the body.

[0076] Example 12

[0077] The endovascular device of any of the above examples, wherein the lock comprises at least one of a snap fit element, a friction fit element, a magnet, a detent, or a locking tab.

[0078] Example 13

[0079] The endovascular device of any of the above examples, wherein the lock is releasable by a user.

[0080] Example 14

[0081] The endovascular device of any of the above examples, wherein the lock is configured for multiple cycles of lock and release.

[0082] Example 15

[0083] The endovascular device of any of the above examples, wherein the lock is configured to generate audible or tactile feedback to a user when engaged.

[0084] Example 16

[0085] The endovascular device of any of the above examples, wherein the tip portion is configured to be passive.

[0086] Example 17

[0087] The endovascular device of any of the above examples, wherein the tip portion is configured to be bent into a predetermined shape.

[0088] Example 18

[0089] The endovascular device of any of the above examples, wherein the expandable portion comprises one or more of a mesh, a stent or a balloon.

[0090] Example 19

[0091] The endovascular device of any of the above examples, wherein the mesh or stent is self-expanding.

[0092] Example 20

[0093] The endovascular device of any of the above examples, further comprising a control element disposed inside the body, the control element extending at least from a proximal end of the body to the mechanical treatment portion, wherein the control element is configured to control expansion and / or contraction of the expandable portion.

[0094] Example 21

[0095] The endovascular device of any of the above examples, wherein the actuation control further comprises a second slider slidably disposed on the exterior of the housing, and wherein the control element enters into the actuation control and is coupled to the second slider such that movement of the second slider moves the control element in an axial direction to control expansion of the expandable portion.

[0096] Example 22

[0097] The endovascular device of any of the above examples, wherein the actuation control further comprises: an actuator disposed in the housing, wherein the control element enters into the actuation control and is coupled to the actuator, and a button configured to control the actuator to control expansion and / or contraction of the expandable portion.

[0098] Example 23

[0099] The endovascular device of any of the above examples, further comprising a control element disposed inside the body, the control element extending from a proximal end of the body to the mechanical treatment portion, wherein the control element is configured to control expansion and / or contraction of the expandable portion, wherein the actuation control further comprises a second slider slidably disposed on the exterior of the housing, wherein the control element enters into the actuation control and is coupled to the secondslider such that movement of the second slider moves the control element in an axial direction to control expansion and / or contraction of the expandable portion, wherein the slider and the second slider are disposed at different rotational positions with respect to a longitudinal axis of the housing.

[0100] Example 24

[0101] The endovascular device of any of the above examples, wherein the actuation control further comprises a control element actuation knob rotatably connected to the housing at a first end of the knob, the knob having a passage formed through the knob; and a shaft disposed in the housing and the knob, the shaft comprises a connection point configured to connect to one of the control element or the body, wherein the shaft comprises an element configured to prevent rotation of the shaft with respect to the housing, and configured to allow the shaft to translate along the housing in a longitudinal direction, the shaft further comprising a mechanism configured to convert rotational motion of the knob to linear motion of the shaft, wherein rotation of the knob rotates the shaft to move in the longitudinal direction.

[0102] Example 25

[0103] The endovascular device of any of the above examples, wherein the tip portion, the mechanical treatment portion, and the proximal portion are positioned in that order from a distal end to a proximal end of the body.

[0104] Example 26

[0105] The endovascular device of any of the above examples, wherein the expandable portion is configured to expand beyond an outer diameter of at least part of the body.

[0106] Example 27

[0107] The endovascular device of any of the above examples, wherein the expandable portion is configured to expand after becoming deployed by the tube.

[0108] Example 28

[0109] The endovascular device of any of the above examples, wherein the tube is sized to fit within a catheter.

[0110] Example 29[OHl] The endovascular device of any of the above examples, wherein the catheter is an access catheter.

[0112] Example 30

[0113] The endovascular device of any of the above examples, wherein the catheter is an aspiration catheter.

[0114] Example 31

[0115] The endovascular device of any of the above examples, wherein a distance traveled by the tube between the proximal position of the tube and the distal position of the tube is equal to a length of the mechanical treatment portion plus a predetermined distance.

[0116] Example 32

[0117] The endovascular device of any of the above examples, wherein the predetermined distance comprises a distance in the range of 1 to 50 mm.

[0118] Example 33

[0119] In an example, a method of operating an endovascular device, comprises: providing the endovascular device of any one of the above examples; navigating the endovascular device to a treatment site in a patient; and sliding the tube to deploy the expandable portion for treatment.

[0120] Example 34A

[0121] The method of any of the above examples, wherein navigating the endovascular device to the treatment site is affected within a catheter.

[0122] Example 34B

[0123] The method of any of the above examples, wherein a catheter is navigated over an endovascular device to the treatment site.

[0124] Example 35

[0125] The method of any of the above examples, wherein the catheter is an aspiration catheter or an access catheter.

[0126] Example 36

[0127] The method of any of the above examples, further comprising: detecting a position of the endovascular device with respect to the treatment site by using imaging to detect a marker disposed on the tube and / or on the body.

[0128] 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 thepresent 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.

[0129] 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.

[0130] 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.

[0131] 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.

[0132] 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 endovascular device, comprising:a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion; anda tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion, and wherein a distance traveled by the tube between the proximal position of the tube and the distal position of the tube is equal to a length of the mechanical treatment portion plus a predetermined distance.

2. An endovascular device, comprising:a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion;a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion; andan actuation control configured to control movement of the tube and the expandable portion.

3. An endovascular device, comprising:a body formed with a tip portion, a mechanical treatment portion comprising an expandable portion, and a proximal portion proximate to the mechanical treatment portion;a tube slidably disposed around at least a portion of the body, wherein the tube is configured to slide between a distal position of the tube where the tube covers at least the expandable portion, and a proximal position of the tube where the tube is not covering the expandable portion; anda lock configured to lock the tube in the proximal position of the tube.

4. The endovascular device of claim 1 or 3, further comprising an actuation control configured to control movement of at least one of the tube and the expandable portion.

5. The endovascular device of claim 2 or 4, wherein the actuation control comprises:a housing; anda slider slidably disposed on an exterior of the housing, wherein the tube extends into the housing and is coupled to a portion of the slider extending into the housing such that movement of the slider slides the tube along the body in an axial direction.

6. The endovascular device of claim 5, further comprising a stop disposed in the housing and positioned to block the slider from sliding proximally beyond a proximal position of the slider that corresponds to the proximal position of the tube.

7. The endovascular device of claim 5 or 6, further comprising a stop disposed in the housing and positioned to block the slider from sliding distally beyond a distal position of the slider that corresponds to the distal position of the tube.

8. The endovascular device of any one of claims 2 or 4-7, wherein an exterior of the actuation control is configured to act as a stop that contacts a proximal end of the tube and stops the tube from sliding proximally beyond a proximal position of the tube.

9. The endovascular device of any one of claims 1-8, wherein the tube comprises a grip disposed on an exterior of the tube, the grip positioned to allow a user to slide the tube along the body.

10. The endovascular device of any one of claims 1-2 or 4-9, further comprising a lock configured to lock the tube in the proximal position of the tube.

11. The endovascular device of claim 3 or 10, wherein the lock comprises:a lock proximal portion located at the proximal end of the tube; anda lock distal portion coupled to one of a distal portion of an exterior of an actuation control housing or to a portion of the body.

12. The endovascular device of any one of claims 3 or 10-11, wherein the lock comprises at least one of a snap fit element, a friction fit element, a magnet, a detent, or a locking tab.

13. The endovascular device of any one of claims 3 or 10-12, wherein the lock is releasable by a user.

14. The endovascular device of any one of claims 3 or 10-13, wherein the lock is configured for multiple cycles of lock and release.

15. The endovascular device any one of claims 3 or 10-14, wherein the lock is configured to generate audible or tactile feedback to a user when engaged.

16. The endovascular device of any one of claims 1-15, wherein the tip portion is configured to be passive.

17. The endovascular device of any one of claims 1-15, wherein the tip portion is configured to be bent into a predetermined shape.

18. The endovascular device of any one of claims 1-17, wherein the expandable portion comprises one or more of a mesh, a stent or a balloon.

19. The endovascular device of claim 18, wherein the mesh or stent is self-expanding.

20. The endovascular device of any one of claims 1-19, further comprising a control element disposed inside the body, the control element extending at least from a proximal end of the body to the mechanical treatment portion, wherein the control element is configured to control expansion and / or contraction of the expandable portion.

21. The endovascular device of any one of claims 2 or 4-20, wherein the actuation control further comprises a second slider slidably disposed on the exterior of the housing, and wherein the control element enters into the actuation control and is coupled to the second slider such that movement of the second slider moves the control element in an axial direction to control expansion and / or contraction of the expandable portion.

22. The endovascular device of any one of claims 2 or 4-20, wherein the actuation control further comprises:an actuator disposed in the housing, wherein the control element enters into the actuation control and is coupled to the actuator, anda button configured to control the actuator to control expansion and / or contraction of the expandable portion.

23. The endovascular device of any one of claims 1-19,further comprising a control element disposed inside the body, the control element extending from a proximal end of the body to the mechanical treatment portion, wherein the control element is configured to control expansion and / or contraction of the expandable portion,wherein the actuation control further comprises a second slider slidably disposed on the exterior of the housing,wherein the control element enters into the actuation control and is coupled to the second slider such that movement of the second slider moves the control element in an axial direction to control expansion and / or contraction of the expandable portion, wherein the slider and the second slider are disposed at different rotational positions with respect to a longitudinal axis of the housing.

24. The endovascular device of any one of claims 2 or 4-20, wherein the actuation control further comprises a control element actuation knob rotatably connected to the housing at a first end of the knob, the knob having a passage formed through the knob; anda shaft disposed in the housing and the knob, the shaft comprises a connection point configured to connect to one of the control element or the body, wherein the shaft comprises an element configured to prevent rotation of the shaft with respect to the housing, andconfigured to allow the shaft to translate along the housing in a longitudinal direction, the shaft further comprising a mechanism configured to convert rotational motion of the knob to linear motion of the shaft, wherein rotation of the knob rotates the shaft to move in the longitudinal direction with respect to the housing, and controls the expansion and / or contraction of the expandable portion.

25. The endovascular device of any one of claims 1-24, wherein the tip portion, the mechanical treatment portion, and the proximal portion are positioned in that order from a distal end to a proximal end of the body.

26. The endovascular device of any one of claims 1-25, wherein the expandable portion is configured to expand beyond an outer diameter of at least part of the body.

27. The endovascular device of any one of claims 1-26, wherein the expandable portion is configured to expand after becoming deployed by the tube.

28. The endovascular device of any one of claims 1-27, wherein the tube is sized to fit within a catheter.

29. The endovascular device of claim 28, wherein the catheter is an access catheter.

30. The endovascular device of claim 29, wherein the catheter is an aspiration catheter.

31. The endovascular device of any one of claims 2-30, wherein a distance traveled by the tube between the proximal position of the tube and the distal position of the tube is equal to a length of the mechanical treatment portion plus a predetermined distance.

32. The endovascular device of any one of claims 1-31, wherein the predetermined distance comprises a distance in the range of 1 to 50 mm.

33. A method of operating an endovascular device, comprising:providing the endovascular device of any one of claims 1-32;navigating the endovascular device to a treatment site in a patient;sliding the tube to deploy the expandable portion for treatment.

34. The method of claim 33, wherein navigating the endovascular device to the treatment site is affected within a catheter.

35. The method of claim 34, wherein the catheter is an aspiration catheter.

36. The method of any one of claims 33-35, further comprising:detecting a position of the endovascular device with respect to the treatment site by using imaging to detect a marker disposed on the tube and / or on the body.

Images