Patent Description:
A variety of procedures can be performed by manipulating an intravascular interventional element connected to a manipulation member, such as, for example, a wire or hypotube. In some instances, interventional elements can be manipulated by a practitioner from a location outside the body using the manipulation member. Thus, the manipulation member may extend from a location outside the body to a treatment location within the body. The manipulation member may extend through a catheter from the location outside the body to the treatment location. Intravascular interventional elements can be connected to manipulation members in a variety of ways. <CIT> discloses devices for removing clot material from a blood vessel lumen and associated systems and methods. <CIT> discloses an endoscope system. <CIT> discloses devices, methods, kits, and methods remove clot material from the vasculature and other body lumens. <CIT> discloses a clot removal device comprising a proximal pinch section, a distal section, and a proximal joint. <CIT> discloses a thrombus removal device.

The invention is defined by the independent claim and other embodiments are listed in the dependent claims. No methods are claimed.

The present technology is illustrated, for example, according to various aspects described below.

A device for intravascular intervention, the device comprising:.

Additional features and advantages of the present technology are described below, and in part will be apparent from the description, or may be learned by practice of the present technology. The advantages of the present technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.

In the following detailed description, specific details are set forth to provide an understanding of the subject technology. It will be apparent, however, to one ordinarily skilled in the art that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

The present technology provides devices, systems, and methods for removing clot material from a blood vessel lumen. Although many of the embodiments are described below with respect to devices, systems, and methods for treating a cerebral or intracranial embolism, other applications and other embodiments in addition to those described herein are within the scope of the technology. For example, the treatment systems and methods of the present technology may be used to remove emboli from body lumens other than blood vessels (e.g., the digestive tract, etc.) and/or may be used to remove emboli from blood vessels outside of the brain (e.g., pulmonary, abdominal, cervical, or thoracic blood vessels, or peripheral blood vessels including those within the legs or arms, etc.). In addition, the treatment systems and methods of the present technology may be used to remove luminal obstructions other than clot material (e.g., plaque, resected tissue, foreign material, etc.).

<FIG> is a schematic illustration of an example medical device <NUM> for intravascular intervention, according to some embodiments. The device <NUM> illustrated in <FIG> comprises an interventional element <NUM> and a manipulation member <NUM> joined at a connection <NUM>. The device <NUM> is illustrated as extending out of a distal end of a catheter <NUM>.

The interventional element <NUM> can comprise an element for performing an intravascular intervention, for example a stent-like device or other type of interventional elements. The interventional element <NUM> can comprise a device configured for various purposes, such as, for example, aneurysm bridging or treatment of ischemic stroke. In various embodiments, the interventional element <NUM> can take any number of forms, for example a removal device, a thrombectomy device, or other suitable medical device. For example, in some embodiments the interventional element <NUM> may be a stent and/or stent retriever, such as Medtronic's Solitaire™ Revascularization Device, Stryker Neurovascular's Trevo® ProVue™ Stentriever, or other suitable devices. In some embodiments, the interventional element <NUM> may be a coiled wire, a weave, and/or a braid formed of a plurality of braided filaments. Examples of suitable interventional element <NUM> include any of those disclosed in <CIT>, <CIT>, <CIT>, and <CIT>.

The manipulation member <NUM> can be any suitable elongate member configured to advance the interventional element <NUM> to a treatment site within a blood vessel. For example, the manipulation member <NUM> can be or include a wire, tube (e.g., a hypotube), coil, or any combination thereof. The manipulation member <NUM> can have a length sufficient to extend from a location outside the patient's body through the vasculature to a treatment site within the patient's body. The manipulation member <NUM> can be monolithic or formed of multiple joined segments, in some embodiments. In some embodiments, the manipulation member <NUM> can include a laser-cut hypotube having a spiral cut pattern (or other pattern of cut voids) formed in its sidewall along at least a portion of its length. The manipulation member <NUM> can comprise or consist of nickel titanium alloy, stainless steel, or other metals or alloys, or any polymer, suited for intracorporeal use. In embodiments that comprise multiple joined segments, the segments may be of the same or different materials. For example, some or all of the manipulation member <NUM> can be formed of stainless steel, or other suitable materials known to those skilled in the art. Nickel titanium alloy may be preferable for kink resistance and reduction of imaging artifacts.

The catheter <NUM> can be configured to access relatively distal locations in a patient including, for example, the middle cerebral artery (MCA), internal carotid artery (ICA), the Circle of Willis, and tissue sites more distal than the MCA, ICA, and the Circle of Willis. The MCA, as well as other vasculature in the brain or other relatively distal tissue sites (e.g., relative to the vascular access point), may be relatively difficult to reach with a catheter, due at least in part to the tortuous pathway (e.g., comprising relatively sharp twists or turns) through the vasculature to reach these tissue sites. As such, the catheter may be structurally configured to be relatively flexible, pushable, and relatively kink- and buckle-resistant, so that it may resist buckling when a pushing force is applied to a relatively proximal section of the catheter to advance the catheter distally through vasculature, and so that it may resist kinking when traversing around a tight turn in the vasculature. In some examples, the catheter <NUM> is configured to substantially conform to the curvature of the vasculature. In addition, in some examples, the catheter <NUM> has a column strength and flexibility that allow at least distal portion of the catheter to be navigated from a femoral artery, through the aorta of the patient, and into the intracranial vascular system of the patient, e.g., to reach a relatively distal treatment site.

Although primarily described as being used to reach relatively distal vasculature sites, the catheter <NUM> may also be configured to be used with other target tissue sites. For example, the catheter <NUM> may be used to access tissue sites throughout the coronary and peripheral vasculature, the gastrointestinal tract, the urethra, ureters, fallopian tubes, veins and other body lumens.

According to some embodiments, the catheter <NUM> can be formed as a generally tubular member extending along and about a central axis. According to some embodiments, the microcatheter <NUM> can be generally constructed to track over a conventional guidewire in the cervical anatomy and into the cerebral vessels associated with the brain and may also be chosen according to several standard designs that are generally available. Accordingly, the catheter <NUM> can have a length that is at least <NUM> long, and more particularly may be between about <NUM> and about <NUM> long. In some embodiments, the catheter can have a lumen diameter of less than about <NUM>", such as about <NUM>", <NUM>", or <NUM>" lumen diameter. Other designs and dimensions are contemplated.

During advancement, the interventional element <NUM> can be removably disposed within the catheter <NUM> in a low-profile or constrained configuration. Once the catheter <NUM> is in positioned such that its distal end is adjacent a treatment site (e.g., a site of a blood clot within the vessel), the interventional element <NUM> can be released from the catheter <NUM> (e.g., via proximal retraction of the catheter <NUM>), and the interventional element <NUM> may be released into its expanded state.

According to some embodiments, the body of the catheter <NUM> can be made from various thermoplastics, e.g., polytetrafluoroethylene (PTFE or TEFLON®), fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), polyether ether ketone (PEEK), etc., which can optionally be lined on the inner surface of the catheter or an adjacent surface with a hydrophilic material such as polyvinylpyrrolidone (PVP) or some other plastic coating. Additionally, either surface can be coated with various combinations of different materials, depending upon the desired results.

The interventional element <NUM> and the manipulation member <NUM> can be substantially permanently attached together at the connection <NUM>. That is, the interventional element <NUM> and the manipulation member <NUM> can be attached together in a manner that, under the expected use conditions of the device <NUM>, the interventional element and the manipulation member would not become unintentionally separated from one another. In some embodiments, the device <NUM> can comprise a portion, located proximally or distally of the connection <NUM>, that is configured for selective detachment of the interventional element <NUM> from the manipulation member <NUM>. For example, such a portion can comprise an electrolytically severable segment of the manipulation member. In some embodiments, the device <NUM> can be devoid of any feature that would permit selective detachment of the interventional element <NUM> from the manipulation member <NUM>. As described in more detail elsewhere herein, in some embodiments the connection <NUM> can provide a mechanical interlock between the interventional element <NUM> and the manipulation member <NUM>.

<FIG> illustrates an enlarged perspective view of the connection <NUM>, according to some embodiments, between the manipulation member <NUM> and the interventional element <NUM>. <FIG> illustrates a schematic top view of the attachment portion <NUM> of the manipulation member <NUM>. <FIG> illustrates a plan view of an interventional element <NUM> including a proximal end portion <NUM>, and <FIG> illustrates an enlarged detail view of the proximal end portion <NUM> of the interventional element <NUM>. <FIG> illustrate schematic top and side views, respectively, of the connection <NUM> between the manipulation member <NUM> and the interventional element <NUM>, including a joining element <NUM>. <FIG> illustrates a schematic side view of the connection <NUM> with the joining element <NUM> omitted for clarity.

With reference to <FIG> together, the connection <NUM> can comprise an attachment portion <NUM> of the manipulation member <NUM>. The attachment portion <NUM> can extend through a hole <NUM> disposed in a proximal portion <NUM> of the interventional element <NUM>. A joining element <NUM> (e.g., a band, sleeve, collar, clip, coil or other suitable structure) can at least partially circumferentially surround at least a portion of the proximal portion <NUM> of the interventional element <NUM>. A plurality of engagement members <NUM> disposed on a retention portion <NUM> of the interventional element <NUM> can be positioned proximal of the joining element <NUM> and configured to engage the joining element <NUM> to retain the interventional element <NUM> with respect to the manipulation member <NUM>, as described in more detail herein.

The connection <NUM> can be dimensioned to fit through a catheter (e.g., catheter <NUM>) for delivery to a treatment location within the body of a patient. In some embodiments, the connection <NUM> can be dimensioned fit through a microcatheter suitable for delivery into the neurovasculature. For example, the microcatheter can have an inner diameter of about <NUM> inch or less, about <NUM> inch or less, or about <NUM> inch or less. <NUM> inch = <NUM>.

In some embodiments, the manipulation member <NUM> can taper between a proximal end and a distal end, for example having a larger diameter at the proximal end than at the distal end. The manipulation member <NUM> can taper continuously or in spaced increments or discrete locations along all or a portion of its length. Any tapering portion of the manipulation member <NUM> can taper at a constant rate or at a variable rate per unit length. The attachment portion <NUM> can taper from a diameter of approximately <NUM> inch, at a location just proximal to the connection <NUM>, to approximately <NUM> inch, at the terminal and the manipulation member <NUM>. In some embodiments, manipulation member <NUM> can have a diameter of approximately <NUM> inch along the attachment portion <NUM>.

As best seen in <FIG>, the attachment portion <NUM> can comprise a first segment <NUM>, the second segment <NUM>, and a bend <NUM> between the first and second segments. In some embodiments, the attachment portion <NUM> can form a hook or u-shaped element. One or both of the first segment <NUM> and the second segment <NUM> can be substantially straight or curved. In some embodiments, the first segment <NUM> and the second segment <NUM> can be generally parallel to each other away from the bend <NUM>. As illustrated, a distal terminal end of the manipulation member <NUM> can be located proximal of the bend <NUM> in the device manipulation member <NUM>. In some embodiments, the attachment portion <NUM> can comprise a bend of approximately <NUM>°.

In some embodiments, manipulation member <NUM> can have a nominal diameter of <NUM> inch at the bend <NUM> of the attachment portion <NUM>. In some embodiments, the manipulation member <NUM> has a circular cross-section prior to being bent, and an ovoid cross-section after being bent. In some embodiments, the bend <NUM> can have a radius that is less than double a maximum cross-sectional dimension, e.g., diameter, of the manipulation member <NUM> in the bend. In some embodiments, the bend <NUM> can have a radius that is less than a maximum cross-sectional dimension, e.g., diameter, of the manipulation member <NUM> in the bend. In some embodiments, the bend radius can vary through the bend.

The attachment portion <NUM> can have a maximum lateral dimension that is measured in a direction perpendicular to a longitudinal axis, extending in a proximal-distal direction, of the device <NUM>. In some embodiments, the maximum lateral dimension is less than <NUM> inch, less than <NUM> inch, or less than <NUM> inch. In some embodiments, the maximum lateral dimension is less than <NUM>, less than <NUM>, or less than <NUM>. In some embodiments, the maximum lateral dimension is less than four times a maximum cross-sectional dimension, e.g., diameter, of the manipulation member <NUM> along the attachment portion <NUM>. In some embodiments, the maximum lateral dimension is less than <NUM>, less than <NUM>, or less than <NUM>. In some embodiments, the maximum lateral dimension is less than three times a maximum cross-sectional dimension, e.g., diameter, of the manipulation member <NUM> along the attachment portion <NUM>.

<FIG> is a plan view of an interventional element <NUM>, depicted in an unfurled or flattened configuration for ease of understanding, and <FIG> is an enlarged detail view of the proximal portion <NUM> of the interventional element <NUM>. The proximal portion <NUM> can be formed of any of nickel titanium alloy, stainless steel, or other materials suitable for introduction into the body for intravascular intervention. The proximal portion <NUM> can be configured such that the attachment portion <NUM> of the manipulation member <NUM> can extend around a part of the proximal portion <NUM>. For example, the proximal portion <NUM> can comprise an opening <NUM>, such as a hole, slot, window, or aperture, therethrough.

The opening <NUM> shown in <FIG> can be sized and shaped to permit the bend <NUM> of the attachment portion <NUM> to extend therethrough. For example, the opening <NUM> can be slightly larger than the cross-section of the attachment portion <NUM> that extends through the hole. The opening <NUM> can be ovoid, for example. The hole or slot can be located proximate a proximal terminal end of the interventional element <NUM>.

The proximal portion <NUM> of the interventional element <NUM> can comprise a retention portion <NUM> positioned proximally of the opening <NUM>. The retention portion <NUM> can include one or more projections or arms <NUM> extending proximally of the opening <NUM>. In some embodiments, each arm <NUM> can include an engagement member <NUM>, for example a protrusion, flange, bump, ridge, shoulder, barb, or other suitable structural feature. In some embodiments, the engagement member <NUM> extends radially or laterally outwardly away from the arm <NUM> and/or away from a central longitudinal axis of the device <NUM>. The engagement member <NUM> can be positioned at a proximal portion (e.g., at or near a proximal terminus) of its arm <NUM>. In some embodiments, the engagement member <NUM> can be positioned at other locations with respect to the arm <NUM>. In some embodiments, the proximal portion <NUM> of the interventional element <NUM>, including the retention portion <NUM> can have a substantially constant thickness, such as would result from the interventional element <NUM> being cut from a tube or sheet of material, for example. In other embodiments, the thickness of the proximal portion <NUM> can vary across its length, width, or both.

The arms <NUM> can optionally be configured such that the lateral or radial distance between their outer edges is slightly larger than an inner diameter or inner width of the joining element <NUM>. In such embodiments, the arms <NUM> maintain a residual spring tension or outward pre-load or bias when the joining element <NUM> is in place on the arms. This is because the joining element <NUM> prevents the arms from moving laterally outward to the rest or unbiased position that they would otherwise occupy. The resulting residual tension increases the stability of the connection and maintains the joining element in position on the arms <NUM>.

In the illustrated embodiment, the retention portion <NUM> includes two arms <NUM> arranged symmetrically with respect to a central longitudinal axis <NUM> and spaced apart from one another laterally to define a region <NUM>. In various embodiments, the number of arms <NUM> can vary. For example, the retention portion <NUM> can include a single arm <NUM>, or three, four, five, six, or more arms <NUM>. Similarly, only some of the arms <NUM> may include an engagement member <NUM>, or all of the arms <NUM> may include an engagement member <NUM>.

The engagement members <NUM> of the retention portion <NUM> can each comprise a distal-facing surface <NUM> and a proximal-facing surface <NUM>. In some embodiments, the distal-facing surface <NUM> forms a shoulder, planar surface, flange, or other suitable engagement surface that is configured to abut or otherwise engage with a corresponding engagement surface of the joining element <NUM>. The For example, as seen in <FIG>, the distal-facing surface <NUM> can be positioned to abut the proximal end face <NUM> of the joining element <NUM>. In some embodiments, the distal-facing surface <NUM> can extend radially outwardly away from the arm <NUM>, for example extending laterally to an extent, measured from the arm <NUM>, that is greater than a wall thickness of the joining element <NUM>. In some embodiments, the distal-facing surface <NUM> forms an oblique angle with the longitudinal axis of the device <NUM>, for example being substantially orthogonal to the longitudinal axis of the device <NUM>.

In some embodiments, the proximal-facing surface <NUM> of the engagement member <NUM> can be sloped, for example being sloped radially inwardly in the proximal direction. In this orientation, the engagement members <NUM> can facilitate slidable engagement with the joining element <NUM> to achieve mechanical interlock. For example, with the manipulation member <NUM> positioned such that the attachment portion <NUM> extends through the hole <NUM> in the interventional element <NUM>, the joining element <NUM> can be first positioned proximal to the interventional element <NUM>, with the manipulation member <NUM> extending through a lumen of the joining element <NUM>. As the joining element is slidably advanced in a distal direction, a distal end face <NUM> of the joining element may contact the proximal-facing surfaces <NUM> of the engagement members <NUM>. Due to the sloped surfaces of the proximal-facing surfaces <NUM>, the engagement members <NUM> and the arms <NUM> can be urged radially inwardly, into a flexed or bowed configuration. In this state, the combined lateral dimension of the engagement members <NUM> can be less than a lumen diameter of the joining element <NUM>, such that the joining element <NUM> can be slidably advanced in a distal direction over the engagement members <NUM>. Once the proximal end face <NUM> of the joining element <NUM> has moved distally beyond the distal-facing surfaces <NUM> of the engagement members <NUM>, the engagement members <NUM> may be at least partially released from the radially constrained state (e.g., the arms <NUM> may move radially outwardly) to achieve the interlocked configuration shown in <FIG>. Once in this interlocked configuration, distal movement of the interventional element <NUM> is limited by engagement between the distal-facing surfaces <NUM> and the joining element <NUM>.

In some embodiments, the arms <NUM> can be configured such that they do not underlie the attachment portion <NUM> of the manipulation member <NUM> in the device <NUM>. For example, the arms <NUM> do not extend into the region <NUM>. In some embodiments, when the attachment portion <NUM> of the manipulation member <NUM> is mated with the proximal end portion <NUM> of the interventional element <NUM>, one or both of the first segment <NUM> and the second segment <NUM> of the attachment portion <NUM> can extend into the space <NUM> located between the arms <NUM> of the retention portion <NUM>.

In some embodiments, the retention portion <NUM> can have a length sufficient to permit, or facilitate, deformation of a portion of the manipulation member <NUM> into the region <NUM>. In some embodiments, the retention portion <NUM> can extend proximally a distance sufficient to allow manipulation of the retention portion <NUM> while the interventional element <NUM> is positioned within the cerebral vasculature and the retention portion <NUM> extends through an access catheter. In some embodiments, the retention portion <NUM> can extend proximally indefinitely.

<FIG> illustrates another embodiment of a retention portion <NUM> of an interventional element <NUM>. <FIG> illustrate top and side views, respectively, of a connection <NUM> using the retention portion <NUM> shown in <FIG>. In the illustrated embodiment, the retention portion <NUM> includes distal engagement members <NUM> in addition to the proximal engagement members <NUM> as in the embodiment shown in <FIG>. As illustrated in <FIG>, each arm <NUM> can include a distal engagement member <NUM>, which can take the form of a shoulder, barb, ridge, bump, protrusion, or other suitable structural feature configured to engage the joining element <NUM>. In the illustrated embodiment, the distal engagement members <NUM> each include a proximal-facing surface <NUM> and a distal-facing surface <NUM>. The proximal-facing surface <NUM> can take the form of a flange, shoulder, or other engagement surface configured to abut the distal end face <NUM> of the joining element <NUM>. The distal-facing surfaces <NUM> can be sloped, for example being sloped radially inwardly in the distal direction. In other embodiments, the distal-facing surfaces <NUM> can assume other shapes or configurations. In operation, the proximal-facing surfaces <NUM> can abut the joining element <NUM> to limit distal movement of the interventional element <NUM> with respect to the joining element <NUM>.

As noted above, the connection <NUM> can comprise a joining element <NUM> in the form of a band, collar, coil, etc. in some embodiments. For example, a circumferential band can hold the attachment portion <NUM> against the retention portion <NUM> and/or otherwise maintain the portions <NUM>, <NUM> in an interlocked relationship. Additionally or alternatively, the band can serve as a radiopaque marker. In some embodiments, the band can hinder separation of the attachment portion <NUM> from the retention portion <NUM>. In some embodiments, the band can be slid or crimped onto one or both of the attachment portion <NUM> and the retention portion <NUM>. In some embodiments, the band can be slid or crimped onto each of the attachment portion <NUM> and the retention portion <NUM>. In embodiments wherein band serves as a radiopaque marker, sliding or crimping the band directly to the retention portion <NUM> can retain the marker band on the retention portion <NUM> in the unlikely event of unintentional separation of the manipulation member <NUM> from the interventional element <NUM>.

The joining element <NUM> can surround all or a portion of the length of the attachment portion <NUM>, the retention portion <NUM>, or both in the device <NUM>. In some embodiments, the joining element <NUM> does not extend over at least a part of the proximal portion <NUM> of the interventional element <NUM>. For example, in some embodiments, the joining element <NUM> does not surround a part, of the proximal portion <NUM>, that surrounds the opening <NUM>.

The joining element <NUM> can be a sleeve that is circumferentially continuous. Alternatively, the joining element <NUM> can be circumferentially discontinuous and can have lateral edges that overlap when the band is attached at the connection <NUM>. In some embodiments, a clip that only partially surrounds all or a portion of the length of the attachment portion <NUM>, the retention portion <NUM>, or both in the device <NUM> can be used in addition or alternative to the joining element <NUM>. In some embodiments, the joining element completely or substantially surrounds at least a section of the attachment portion <NUM> and a segment of the retention portion <NUM>.

In embodiments wherein the joining element serves as a marker, the joining element can be formed of a radiopaque material such as, for example, platinum or platinum alloys, including platinum-iridium. In some embodiments, the joining element can be formed of a non-radiopaque material.

The joining element <NUM> can have a maximum cross-sectional (lateral) dimension that is <NUM> inch or less, <NUM> inch or less, or <NUM> inch or less, in some embodiments. The joining element <NUM> can have cross-sectional dimension(s) that inhibit or prevent movement of the joining element distally over the proximal portion <NUM> of the interventional element <NUM>. For example, the cross-sectional dimension can be a diameter (inner or outer) that is less than a width of the proximal portion <NUM>.

In some embodiments, the connection <NUM> can comprise a bonding agent in addition or alternative to the band in some embodiments. The bonding agent can strengthen the connection <NUM> between the interventional element <NUM> to the manipulation member <NUM>, and/or hinder separation of the attachment portion <NUM> from the retention portion <NUM>. The bonding agent can bond to each of the attachment portion <NUM> and the retention portion <NUM>. The bonding agent can comprise adhesive, solder, welding flux, brazing filler, etc. In some embodiments, the bonding agent can bond to the attachment portion <NUM> in the retention portion <NUM> without applying heat. For example, the bonding agent can comprise a UV-curable adhesive. In embodiments that comprise a polymer coating of the wire or polymer tubing, use of a bonding agent that avoids application of heat that would damage the polymer may be preferred.

In some embodiments, the bonding agent can cover the bend <NUM> of the attachment portion <NUM>, a proximal end of the connection <NUM>, or both. In embodiments that comprise a band and a bonding agent, the bonding agent can fill all or a portion of an interior volume of the band in addition or alternative to covering one or both ends of the connection <NUM>. By covering one or both ends of the connection <NUM>, the bonding agent can form rounded, atraumatic end surface(s) that cover any relatively sharp ends of the components that form the connection <NUM>. In some embodiments, the manipulation member <NUM> tapers at an intersection with the bonding agent. Tapering of the wire at the intersection with the bonding agent can concentrate stress at the intersection to promote breakage at the intersection in the event that the manipulation member <NUM> breaks, thereby retaining the joining element <NUM> on the interventional element <NUM>. Retention of the band on the interventional element may be desirable in embodiments wherein band serves as a marker.

In some embodiments, the manipulation member <NUM> can be attached to the interventional element <NUM> at the connection <NUM> by the processes described below and variants thereof. The attachment portion <NUM> of the manipulation member <NUM> can be positioned about a part of the proximal portion <NUM> of the interventional element <NUM>. For example, a distal end portion of the manipulation member <NUM> can be passed through the opening <NUM>. The attachment portion <NUM> of the manipulation member <NUM> can extend through the opening <NUM> at the bend <NUM> such that the first segment <NUM> and the second segment <NUM> are on different sides of the proximal portion <NUM> of the interventional element <NUM>. In some embodiments, the terminal distal end of the manipulation member <NUM> can be located proximally of the bend <NUM>. In some embodiments, the manipulation member <NUM> can be bent to interlock with the proximal portion <NUM> of the interventional element <NUM>.

In some embodiments wherein the manipulation member <NUM> comprises a plurality of components, the components of the manipulation member can be assembled together prior to attachment of the manipulation member to the interventional element <NUM>. For example, in some embodiments, a wire, a coil, and one or more tubes can be assembled together, before a portion of the wire is passed through the opening <NUM> in the proximal portion <NUM> of the interventional element <NUM>, before the wire is bent, or both.

The manipulation member <NUM> can be bent in one or more stages between an initial straight configuration and a final configuration in the completed device <NUM>. For example, the manipulation member <NUM> can be bent by an initial amount before any portion of the manipulation member <NUM> is passed through the opening <NUM> and bent a further amount thereafter. The manipulation member <NUM> can be initially bent between <NUM>° and <NUM>°, between <NUM>° and <NUM>°, between <NUM>° and <NUM>°, or between <NUM>° and <NUM>°, from a straight configuration, prior to any portion thereof being passed through the opening <NUM>. After segment of the manipulation member <NUM> has been passed through the opening <NUM>, the manipulation member <NUM> can be bent by a further amount to accommodate the joining element <NUM>, if present. In some embodiments, the manipulation member <NUM> can be finally bent to between <NUM>° and <NUM>°, between <NUM>° in <NUM>°, or between <NUM>° and <NUM>°. Preferably, the final bend <NUM> has no substantial surface crack.

If the joining element <NUM> cannot be positioned over the attachment portion <NUM> without further deflection of the manipulation member <NUM>, the manipulation member <NUM> can be bent, or further bent, to accommodate the joining element <NUM>. In some embodiments, the joining element <NUM> can be positioned over the manipulation member <NUM> or the interventional element <NUM> prior to coupling the manipulation member and the interventional element. The joining element <NUM> can be positioned around all or a portion of the attachment portion <NUM> and all or a portion of the retention portion <NUM> by moving the band and a proximal or distal direction. In some embodiments, the joining element <NUM> is moved over the manipulation member <NUM> in a distal direction and, as the joining element <NUM> is advanced onto the attachment portion <NUM>, a terminal distal end of the wire can be deflected to enter an interior of the joining element <NUM>. Then, the manipulation member can be further bent as the joining element <NUM> is advanced farther distally, and optionally with the terminal distal end of the manipulation member <NUM> being held stationary.

In embodiments that comprise a bonding agent, the bonding agent (not shown) can be applied to the attachment portion <NUM> of the manipulation member <NUM> and the retention portion <NUM> of the interventional element <NUM> after a segment of the manipulation member has been positioned about the proximal portion <NUM>. If the connection <NUM> comprises a band and bonding agent, the bonding agent can be applied at the connection <NUM> before or after the band is attached at the connection <NUM>. If the terminal distal end of the manipulation member <NUM> extends proximally beyond a proximal end of the band, the manipulation member <NUM> can be trimmed so that the terminal distal end of the wire is approximately even with the proximal end of the band before applying the bonding agent.

Although some embodiments comprise both a band and a bonding agent, some embodiments comprise a band without a bonding agent, and some embodiments comprise a bonding agent without a band. Some embodiments can omit both a band and a bonding agent. For example, a manipulation member <NUM> and an interventional element <NUM> can be integrally formed in some embodiments. For another example, a manipulation member <NUM> separately formed from an interventional element <NUM> can be attached to the interventional element without use of a band or bonding agent.

Various methods are available for bending the manipulation member <NUM> prior to attachment to the interventional element <NUM>. For example, the manipulation member <NUM> can be bent around a fixed mandrel. However, bending the wire around a fixed mandrel may yield inconsistent results and may damage wire by introducing surface cracks that reduce the tensile strength of the manipulation member <NUM>. Likewise, manual bending of the wire may likewise yield inconsistent results and may damage the manipulation member <NUM> by introducing substantial surface cracks. For another example, a bend in the manipulation member <NUM> and may be heat set. However, heat setting may require more time than other bending methods and may adversely affect other portions of the manipulation member <NUM>. For example, if the manipulation member includes tubes comprising polymers or other heat sensitive materials, heat setting may damage those portions of the manipulation member <NUM>. These and other methods may be used to bend manipulation member <NUM> comprising stainless steel, nickel titanium alloys, or other metals.

The connection <NUM> can substantially permanently couple the interventional element <NUM> and manipulation member <NUM> during use of the device <NUM> for intravascular intervention. For example, the connection <NUM> can couple the interventional element manipulation member during insertion of the interventional element into a blood vessel, e.g., a cerebral blood vessel, using the manipulation member, manipulation of the interventional element to perform a therapy within the blood vessel, and removal of the interventional element from the blood vessel using the manipulation member. In some embodiments, the device <NUM> can be inserted through a microcatheter. The interventional element can be removed from the blood vessel in some embodiments by proximally pulling the manipulation member <NUM>, for example to retract the interventional element into a microcatheter. The interventional element can be deployed in some embodiments by maintaining a location of the interventional element while retracting the microcatheter from over the interventional element.

With reference to <FIG>, the device <NUM>, including the manipulation member <NUM> and interventional element <NUM>, can be used as a flow restoration device. For example, the interventional element can comprise a self-expanding member used to restore blood flow in a medical patient experiencing ischemic stroke due to large intracranial vessel occlusion. In a preferred arrangement, the device <NUM> can be used in conjunction with a microcatheter <NUM>. The device <NUM> can retrieve thrombi from highly tortuous, small, and thin wall vessels. The device <NUM> can be used to treat vessels with diameters, for example, ranging from <NUM> to <NUM>, such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, anterior cerebral artery, basilar artery and vertebral artery, though other ranges, sizes, and particular vessels are also possible.

During a flow restoration procedure, a balloon guide catheter (not shown) can be moved through the vasculature towards a treatment area. A balloon, located on a distal end of the balloon guide catheter, can be expanded against the walls of a blood vessel <NUM>. The microcatheter <NUM> can first be delivered through the balloon guide catheter. The interventional element <NUM> can then be delivered through the microcatheter <NUM>. Alternatively, the interventional element <NUM> can be delivered with the microcatheter <NUM>. The interventional element <NUM> can be in a volume-reduced form within the microcatheter <NUM>. The microcatheter <NUM> can be advanced through the vessel <NUM> and placed adjacent a thrombus <NUM>. The interventional element <NUM> can be positioned such that the connection <NUM> is upstream of the thrombus <NUM>, a distal end of the interventional element is downstream of the thrombus, and a portion of the interventional element <NUM> is located radially adjacent to the thrombus <NUM>. In a preferred arrangement illustrated in <FIG>, the microcatheter <NUM> can be placed alongside the thrombus <NUM> such that a distal tip <NUM> of the microcatheter <NUM> is beyond the thrombus <NUM>, wherein the distal tip <NUM> is from greater than about <NUM> to about <NUM> or more, or about <NUM> to about <NUM> beyond the thrombus <NUM>, though other ranges and values are also possible. In a preferred arrangement, the interventional element <NUM> can be positioned such that portions of the interventional element <NUM> extend both proximally and distally of thrombus <NUM>.

As illustrated in <FIG>, the interventional element <NUM> can be held in a fixed position by holding the manipulation member <NUM> stationary while the microcatheter <NUM> is withdrawn (i.e., pulled proximally). As the microcatheter is withdrawn, the interventional element <NUM> can be released from its volume-reduced form, and can expand. The interventional element <NUM> can assume at least a portion of its unconstrained form, thereby expanding to bring at least part of the interventional element <NUM> into penetrating contact with the thrombus <NUM>. If the position of the interventional element <NUM> needs to be adjusted, the manipulation member <NUM> and/or microcatheter <NUM> can be moved together or individually, and if necessary, the interventional element <NUM> can be placed back in the microcatheter and then expanded again, or redeployed.

Once deployed, the interventional element <NUM> can exert an outward radial force on the thrombus <NUM>, as described above, thus reducing the cross-sectional area of the thrombus <NUM>, forming a channel for immediately re-establishing at least partial blood flow through the blood vessel <NUM> past the thrombus <NUM>, and/or loosening the thrombus from the vessel wall. In some embodiments, for example, about <NUM>% to about <NUM>% of the original thrombus <NUM> circumference can be separated from the vessel wall after the interventional element <NUM> is deployed, and the ability of the thrombus <NUM> to hang onto the vessel wall via adhesion and friction can accordingly be reduced. In some embodiments, the cross sectional area of the thrombus <NUM> can be significantly reduced by the deployed interventional element <NUM>, resulting in a thrombus <NUM> having about <NUM>% to about <NUM>% of its original cross sectional area, but more typically about <NUM>% to about <NUM>% of its original cross-sectional area. In some embodiments, administration of an effective amount of a clot-busting drug, such as, for example tissue plasminogen activator (tPA), to the site of the thrombus <NUM> can further be applied during the blood flow restoration procedure to enhance dissolution of the thrombus <NUM>. In some embodiments, the open channel created by the interventional element <NUM> can increase the exposed surface area of the thrombus <NUM>, thereby facilitating faster dissolution of the thrombus <NUM> with such clot-busting drugs.

With reference to <FIG> and <FIG>, once the interventional element <NUM> has engaged and captured the thrombus <NUM>, the thrombus <NUM> can be removed. Prior to pulling back on the manipulation member <NUM>, the microcatheter <NUM> can be manipulated. For example, the microcatheter <NUM> can be moved forward to a predetermined point relative to the interventional element <NUM>. Use of markers along the microcatheter <NUM> and/or interventional element <NUM> can be used to determine the relative locations of the microcatheter <NUM> and interventional element <NUM>. For example, the microcatheter <NUM> can be moved distally until it covers the joining element <NUM>. The microcatheter <NUM> and interventional element <NUM> can then be removed together.

With reference to <FIG>, during retrieval of the device <NUM> and thrombus <NUM>, the initial channel created for flow restoration through or past the thrombus <NUM> can remain open. The balloon can remain inflated to provide for maximum proximal flow control. For example, in some embodiments the balloon can ensure that there is no flow proximally through the vessel from the balloon towards the interventional element <NUM>. As part of the retrieval procedure, continuous aspiration can be employed through the balloon guide catheter with vigorous aspiration when the interventional element <NUM> is near a distal tip of the balloon guide catheter. Aspiration assistance can enable flow reversal through the interventional element <NUM> and thrombus <NUM>. The aspiration with flow reversal can help allow the distal vasculature to continue to have blood perfusion through the vessels during the retrieval process and can inhibit the possibility of distal emboli. There can be an advantage to having blood flow across the self-expanding device <NUM> and thrombus <NUM> with the potential of natural lysing of blood and increased surface area for thrombus dissolving medicines, if they are provided. The aspiration with flow reversal can also assist in the thrombus retrieval process by aiding in the removal of the thrombus <NUM>. The flow can be directed towards the lumen of the balloon guide catheter due to the aspiration. The interventional element <NUM> and thrombus <NUM> can thus be assisted by the flow to enter the lumen of the balloon guide catheter. In some embodiments, if withdrawal into the balloon guide catheter is difficult for any reason during aspiration, the balloon can be deflated, and the balloon guide catheter, microcatheter <NUM>, and the device <NUM> can be withdrawn simultaneously as a unit while maintaining aspiration.

In some embodiments, device <NUM> can be used as a device for use as an implantable member (e.g., stent). For example, the manipulation member <NUM> and interventional element <NUM>, coupled at the connection <NUM>, can be delivered through a microcatheter <NUM> to a treatment site such as a stenosis or aneurysm. Similar to the method described above, the microcatheter can be withdrawn, and the interventional element <NUM> can expand against a vessel wall. Similar to use as a flow restoration device, if necessary, the interventional element <NUM> can be repositioned if it is not placed correctly on a first attempt. Once the interventional element <NUM> is in a desired location at the treatment site, the interventional element <NUM> can then be detached from the manipulation member <NUM> and be used as an implantable member.

This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and functions have not been shown and/or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, in alternative embodiments the steps may have another suitable order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. Accordingly, this disclosure and associated technology can encompass other embodiments not expressly shown and/or described herein.

Claim 1:
A device (<NUM>) for intravascular intervention, the device (<NUM>) comprising:
an elongate manipulation member (<NUM>) comprising a distally located attachment portion, the attachment portion comprising a first segment (<NUM>), a second segment (<NUM>), and a bend (<NUM>) between the first and second segments (<NUM>,<NUM>);
an interventional element (<NUM>) comprising:
a proximal end portion (<NUM>) including a hole (<NUM>) therethrough, the attachment portion of the manipulation member (<NUM>) extending through the hole (<NUM>) at the bend (<NUM>) such that the first and second segments (<NUM>,<NUM>) each extend proximally from the hole (<NUM>); and
a retention portion (<NUM>) comprising an arm (<NUM>) extending proximally of the hole (<NUM>) and a shoulder (<NUM>) protruding radially outwardly from a proximal portion of the arm (<NUM>); and
a joining element (<NUM>) configured to circumferentially surround at least a portion of the retention portion (<NUM>) and at least a portion of the first and second segments (<NUM>,<NUM>) of the elongate member (<NUM>) such that a proximal end of the joining element (<NUM>) is positioned distal to the shoulder (<NUM>) of the retention portion (<NUM>).