Patent Description:
Endovascular procedures address a broad array of medical needs, including endovascular access, diagnosis, and/or repair through minimally invasive or relatively less invasive means than surgical approaches. During some endovascular procedures, embolic debris may become dislodged or circulated in the vasculature. Circulation of embolic debris can cause mild to extreme cardiovascular complications, leading to stroke and even death.

Embolic protection devices have been developed and used in connection with such endovascular procedures to help mitigate the risks associated with various endovascular procedures. Some embolic protection devices operate to capture embolic debris and filter the same from the blood. <CIT> is directed to multi-filter endoluminal methods and systems for filtering fluids within the body. In some embodiments a multi-filter blood filtering system captures and removes particulates dislodge or generated during a surgical procedure and circulating in a patient's vasculature. In some embodiments a dual filter system protects the cerebral vasculature during a cardiac valve repair or replacement procedure. The captured embolic debris can be aspirated (e.g., actively or passively) prior to removal of the embolic protection device. Additionally or alternatively, the embolic protection device can be configured to trap the embolic debris within the embolic protection device such that the embolic debris is retained by the embolic protection device upon its removal from the vasculature. However, a common risk of these procedures is the unintentional release of some or all of the captured embolic debris back into the vasculature during the removal process.

Proper orientation of the embolic protection devices within the vasculature is an important factor in the facilitation of embolic debris capture and removal. However, while conventional devices may be deployable within tortuous vasculature, some lack the means for orienting or repositioning the device within the vasculature after it has been deployed. Poor orientation of embolic protection devices may result in embolic debris bypassing the embolic protection device, such as by way of one or more gaps between the embolic protection device and a vessel wall and/or by embolic debris not being fully captured by the embolic protection device resulting in unintended ejection of the embolic debris back into the blood upon removal of the embolic protection device from the vasculature. Proper orientation is especially difficult in tortuous anatomy.

According to the invention as claimed, a medical device includes, an elongate element having a first end and a second end, and an embolic filter assembly including a frame having an attachment section, a capture section distal to the attachment section, and an intermediate section between the attachment section and the capture section, the attachment section of the embolic filter assembly being coupled to the elongate element at one of the first and second ends, wherein the intermediate section is adapted to allow for relative articulation between the capture section of the frame and the attachment section of the frame, and wherein the intermediate section of the frame is tubular and the attachment section, the capture section, and the intermediate section are formed of the same material.

While multiple examples are disclosed, still other examples will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples.

The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate examples, and together with the description serve to explain the principles of the disclosure.

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. In describing various examples, the term distal is used to denote a position along an exemplary device proximate to or alternatively nearest to the treatment area within a patient's body. The term proximal is used to denote a position along the exemplary device proximate to or alternatively nearest to the user or operator of the device.

Various aspects of the present disclosure are directed toward an embolic filter device, system, and method. An exemplary embolic filter system <NUM> is illustrated in <FIG>. The embolic filter system <NUM> generally includes a filter <NUM> and an elongate element <NUM>. In various examples, the embolic filter system <NUM> is configured such that the filter <NUM> and the elongate element <NUM> can freely articulate relative to one another. As discussed in greater detail below, in some examples, the filter <NUM> includes one or more features that facilitate such relative articulation between the filter <NUM> and the elongate element <NUM>, while in other examples, the embolic filter system <NUM> includes one or more additional components, such as one or more unions that facilitate such relative articulation between the filter <NUM> and the elongate element <NUM>. Providing an embolic filter system <NUM> having a filter <NUM> and elongate element <NUM> that are operable to articulate relative to one another provides that the embolic filter system <NUM> can passively orient itself to achieve proper alignment of the filter <NUM> relative to the vasculature within which it is partially or fully deployed. Alternatively, the embolic filter system <NUM> can also be manipulated in situ by the operator to achieve such alignment.

As shown in <FIG>, the embolic filter system <NUM> includes a distal end <NUM> and a proximal end <NUM>. In some examples, the filter <NUM> extends distally from the elongate element <NUM> such that a distal end <NUM> of the filter <NUM> defines, at least in part, the distal end <NUM> of the embolic filter system <NUM>. Similarly, in some examples, the elongate element <NUM> extends proximally from the filter <NUM> such that a proximal end <NUM> of the elongate element <NUM> defines, at least in part, the proximal end <NUM> of the embolic filter system <NUM>. In various examples, a proximal end <NUM> of the filter <NUM> is coupled with the elongate element <NUM>. In some examples, the proximal end <NUM> of the filter <NUM> is coupled with a distal end <NUM> of the elongate element <NUM>. In some examples, coupling the proximal end <NUM> of the filter <NUM> with the distal end <NUM> of the elongate element <NUM> includes coupling the proximal end <NUM> of the filter <NUM> with the distal end <NUM> of the elongate element <NUM> such that the distal end <NUM> of the elongate element <NUM> is situated distal to the proximal end <NUM> of the filter <NUM> (e.g., such that the filter <NUM> and the elongate element <NUM> partially overlap one another).

In various examples, the embolic filter system <NUM> can be used in combination with one or more auxiliary systems. For example, as shown in <FIG>, one or more auxiliary systems <NUM> including one or more auxiliary components may be utilized in combination with the embolic filter system <NUM>. In some examples, the auxiliary system <NUM> and/or components thereof may be commercial-over-the-shelf (COTS) systems or components. One non-limiting auxiliary system <NUM> includes a COTS catheter. Other non-limiting auxiliary systems <NUM> include constraining sheaths, including tear-away sheaths, valves and connectors such as those used in controlling fluid backflow through one or more of the embolic filter system <NUM> and the auxiliary system <NUM> (e.g., Tuohy-Borst Connector(s)), and control handles. The auxiliary system <NUM> may be used in association with one or more of the delivery, deployment, operation, and/or removal of the embolic filter system <NUM>. It is to be appreciated that, in various examples, the embolic filter system <NUM> may, itself, include one or more of such tear-away sheaths, connectors, and/or valves, such as hemostatic valves.

The embolic filter system <NUM> is generally configured to be advanced to a target site within a patient's vasculature such that one or more components of the embolic filter system <NUM> (such as the filter <NUM>) is antegrade or "downstream" of a treatment area of the vasculature, between the treatment area and one or more anatomical regions where the presence of embolic debris can lead to complications and damage to the anatomy. Those of skill will appreciate that positioning the system downstream from the treatment area provides that embolic and other debris dislodged from the treatment area during a treatment procedure will migrate with the flow of blood toward the embolic filter system <NUM> where the embolic debris can be filtered from the blood.

Properly orienting the filter <NUM> of the embolic filter system <NUM> within a vessel or region of the vasculature is an important factor in facilitating a proper deployment and successful filtering of embolic debris from the blood in association with an endovascular procedure. However, in certain portions of the vasculature and/or under certain conditions, it is difficult to deploy embolic filters such that they are operable to successfully filter embolic debris from the blood. The embolic filter system <NUM> disclosed herein passively aligns itself along a surface of the vasculature such as a vessel wall to cause a relative articulation between the filter <NUM> and the elongate element <NUM>, thus achieving a proper alignment of the filter <NUM> within the vasculature. Alignment within the vasculature generally results in a minimization of gaps between the filter <NUM> and the vessel wall that could operate as avenues through which the embolic debris can bypass the embolic filter system <NUM>. Though, in some embodiments, the embolic filter system <NUM> also affords the operator the ability to deploy the embolic filter system <NUM> and then manipulate the embolic filter system <NUM> to properly align the filter <NUM> with the vasculature.

In various examples, articulation is achieved by one or more of advancement and withdrawal of the elongate element <NUM> with the filter <NUM> fully deployed. For example, advancement and/or withdrawal of the elongate element <NUM> while the filter <NUM> is deployed within the vasculature may operate to impart a compressive or tensile load to one or more of the filter <NUM> and the elongate element <NUM>. As mentioned above, in various examples, the filter <NUM> may include one or more features that facilitate relative articulation between the filter <NUM> and the elongate element <NUM>, while in other examples, the embolic filter system <NUM> includes one or more additional components, such as one or more unions that facilitate relative articulation between the filter <NUM> and the elongate element <NUM>. In various examples, applying compressive and/or tensile load(s), the embolic filter system <NUM> causes the one or more features of the filter <NUM> and/or the one or more additional components to bend, deflect, or otherwise cause deformation thereof to achieve the relative articulation between the filter <NUM> and the elongate element <NUM>.

Once deployed, the embolic filter system <NUM> interacts with blood flowing through the region of the vasculature within which the embolic filter system <NUM> is deployed. In some examples, the embolic filter system <NUM> may be adapted or otherwise configured to filter blood and/or embolic debris as it flows through or otherwise interacts with the embolic filter system <NUM>. In some examples, the embolic filter system <NUM> additionally or alternatively redirects blood flow and/or embolic debris from what would otherwise be a normal or unimpeded flow of blood and/or embolic debris through the surrounding vasculature. Thus, in various examples, the embolic filter system <NUM> can be deployed within a region of a patient's vasculature such that blood and/or embolic debris is filtered and/or redirected as it flows through that region of the patient's vasculature.

With reference now to <FIG>, the filter <NUM> of the embolic filter system <NUM> includes a body <NUM> having the distal and proximal ends <NUM> and <NUM>. The filter <NUM> generally includes a structural element <NUM>, an attachment section <NUM>, and an articulation section <NUM>. In some examples, the articulation section <NUM> is intermediate to the distal and proximal ends <NUM> and <NUM>, and thus may be referred to as an intermediate section. <FIG> is a <NUM>-dimensional plan view of the filter <NUM> showing the full circumference of the filter <NUM>, which has been unwrapped and laid flat to illustrate the relationship between the structural element <NUM>, the attachment section <NUM>, and the articulation section <NUM>.

In various examples, the filter <NUM> is a structure configured to interact with blood and/or embolic debris flowing through the patient's vasculature in the region within which the embolic filter system <NUM> is deployed. As discussed in greater detail below, the filter <NUM> or one or more portions thereof may be formed from a cut tube, a wire frame, a molded or extruded part, or a combination thereof. In some examples, one or more portions of the filter <NUM> may be formed of a shape-memory material such as nitinol, such that the one or more portions thereof possess or exhibit self-expanding properties as would be appreciated by those of skill in the art. In other examples, however, one or more of the components of the filter <NUM> may be formed from other resilient metals that may be expandable through the use of an expansion aid (such as a balloon). For example, one or more of the support elements may be formed from a polymer or a biocompatible metallic alloy such as stainless steel. In some examples, the filter <NUM> or one or more portions thereof may be constructed of a durable elastomeric material, such as polyurethane or densified nylon.

As shown in <FIG>, the filter <NUM> includes a structural element <NUM>. The structural element <NUM> (also referred to herein as a capture section) is configured to direct or funnel blood and embolic debris into an interior region of the filter <NUM> and, in some examples, the elongate element <NUM>. The structural element <NUM>, therefore, operates as an obstruction to the flow of blood that causes the blood to interact with the embolic filter system <NUM> before flowing downstream of the embolic filter system <NUM>. In various examples, the structural element <NUM> is configured to transition between a contracted configuration (e.g., <FIG>) and an expanded configuration (e.g., <FIG>) in conjunction with the embolic filter system <NUM> transitioning from a delivery configuration to a deployed configuration such that the embolic filter system <NUM> can be delivered endovascularly (e.g., at a small delivery profile), while possessing the capability of being deployed in situ to a larger deployed profile conducive for interrupting blood flow to filter embolic debris therefrom.

In the deployed configuration, the filter <NUM> adopts a generally trumpeted, conical, or frustoconical shape in that a transverse cross-sectional area of the filter <NUM> is different at two different longitudinal locations along the filter <NUM> between the distal and proximal ends <NUM> and <NUM> of the filter <NUM>. In some examples, the transverse cross-sectional area of the distal end <NUM> is greater than the transverse cross-sectional area of the proximal end <NUM>. In some examples, the filter <NUM> generally tapers from the distal end <NUM> to the proximal end <NUM> as shown in <FIG> and <FIG>, for example. Such a configuration provides that the filter <NUM> operates to funnel the blood into the filter <NUM> and/or into the elongate element <NUM> as disclosed herein.

In various examples, the structural element <NUM> is comprised of one or more support elements, such as one or more braids, meshes, lattices, wires, rings, struts, or any other suitable support element. For example, as shown in <FIG>, the structural element <NUM> includes a plurality of strut elements <NUM> that are collectively arranged to define one or more closed cells <NUM> that collectively define, at least in part, the structural element <NUM>. As shown, these closed cells <NUM> are arranged in one or more rows (e.g., <NUM>, <NUM>, <NUM>, <NUM>, or more than <NUM> rows). It is to be appreciated, however, that braids, meshes, lattices, wires, rings, and other suitable support elements may be utilized in lieu of or in combination with the strut elements <NUM>, provided that the structural element <NUM> of the filter <NUM> is operable to transition between the contracted and expanded configurations.

In some examples, the closed cells <NUM> are configured to change shape to accommodate or facilitate the transition of the structural element <NUM> between the expanded and contracted configurations. When the structural element <NUM> is in the expanded configuration, for example, the closed cells may be diamond-shaped as shown in <FIG>. It will be appreciated, however, that the shape of the closed cells shown herein is not to be construed as limiting, and that various alternative shapes (e.g., polygonal) and/or sizes are envisioned.

It is also to be appreciated that the number of rows of closed cells and/or the number of closed cells per row may be increased or decreased to achieve a desired expanded profile (e.g., deployed diameter) and a desired contracted profile (e.g., delivery diameter), and thus the examples illustrated herein are not to be construed as limiting. Generally, for a given closed cell size and shape, increasing the number of closed cells <NUM> increases the expanded and contracted profile diameters, and decreasing the number of closed cells <NUM> decreases the expanded and contracted profile diameters. Similarly, for a given closed cell size and shape and number of closed cells <NUM> per row, increasing the number of rows of closed cells <NUM> increases a length of the filter <NUM>, and decreasing the number of rows of closed cells <NUM> decreases the length of the filter <NUM>.

In various examples, in addition to the structural element <NUM>, the filter <NUM> includes one or more portions that are configured to facilitate a coupling of the filter <NUM> to the elongate element <NUM>. For example, as shown in <FIG>, the filter <NUM> includes an attachment section <NUM> that is configured to interface with the elongate element <NUM> to facilitate a coupling between the filter <NUM> and the elongate element <NUM>. The attachment section <NUM> may include one or more features that are configured to help secure the elongate element <NUM> to the attachment section <NUM>. For example, as shown in <FIG>, the attachment section <NUM> includes a plurality of apertures <NUM>. The apertures <NUM> provide reliefs within which the material of the elongate element <NUM> can reside to facilitate a mechanical interference between the filter <NUM> and the elongate element <NUM>. For instance, the elongate element <NUM> may be coupled with the filter <NUM> via melt-bonding or other known methods. For instance, the elongate element <NUM> may be coupled with the filter <NUM> using an adhesive such as an ultraviolet light (UV) curing adhesive (for example a UV curable acrylate), an epoxy, a fluoroelastomer (e.g., FEP), a fluoropolymer adhesive tape, or other means as desired.

It is to be appreciated that while the attachment section <NUM> of the filter <NUM> is shown with apertures <NUM>, the attachment section <NUM> may additionally or alternatively include one or more other features configured to assist in coupling the elongate element <NUM> with the filter <NUM>, such as one or more projections (e.g., one or more boss features) extending circumferentially or about an interior or exterior of the attachment section <NUM> of the filter <NUM> and/or extending longitudinally along the interior or exterior of the attachment section <NUM>. In some such examples, such features may be welded or otherwise affixed to the filter according to known methods.

In various embodiments, situated between the structural element <NUM> and the attachment section <NUM>, is an articulation section <NUM> that is adapted to enable the structural element <NUM> (e.g., the capture section) and the attachment section <NUM> of the filter <NUM> to articulate relative to one another. Such relative articulation provides that the structural element <NUM> is operable to articulate relative to the elongate element <NUM> (and vice versa). While the embolic filter system <NUM> shown in <FIG> includes a filter <NUM> with an articulation section <NUM> integrated therein (e.g., situated between the distal and proximal ends <NUM> and <NUM> of the filter <NUM>), it should be appreciated that, as discussed in greater detail below, an articulation section may additionally or alternatively be situated between a filter and an elongate element. That is, the articulation section may be included in an embolic filter system as an independent component that is coupled with each of the filter and the elongate element.

In various examples, the articulation section <NUM> includes a distal section <NUM> and a proximal section <NUM> and has a length. In some examples, the distal section <NUM> defines a position along the filter <NUM> at which the articulation section <NUM> transitions to the structural element <NUM>. Similarly, in some examples, the proximal section <NUM> defines a position along the filter <NUM> at which the articulation section <NUM> transitions to the attachment section <NUM>.

In various embodiments, the articulation section <NUM> generally includes a coil (e.g., a helical construct) or a slotted segment of the filter <NUM>. In the examples including a cut tube, it is to be appreciated that the cuts in the tube to form the coil/helix or slotted segment extend through the thickness of the tube (e.g., from an exterior surface of the tube to the interior surface of the tube) such that the interior lumen of the tube is exposed. Cutting through the full thickness of the tube in such examples provides that one or more compressible/expandable gaps are formed, as discussed further below. The tube may be formed of resilient materials including, but not limited to, metal alloys (e.g., nitinol), polymeric and elastomeric materials, or a combination thereon. For instance, the articulation section <NUM> may include nylon that is reinforced with a coil of reinforcing material.

In various examples, the particular aspects or features of the articulation section <NUM> (e.g., the pitch of the helix or the size of the slots and distance therebetween) is selected to provide that the structural element <NUM> and one or more of the attachment section <NUM> and the elongate element <NUM> can be articulated relative to one another by a designated amount. For instance, the particular aspects or features of the articulation section <NUM> (such as the pitch "p") can be configured such that the structural element <NUM> and one or more of the attachment section <NUM> and the elongate element <NUM> can be articulated such that a relative angle defined between the longitudinal axes thereof (i.e., an articulation angle) is up to <NUM> degrees, up to <NUM> degrees, up to <NUM> degrees, up to <NUM> degrees, up to <NUM> degrees, up to <NUM> degrees, or in excess of <NUM> degrees, such as up to <NUM> degrees. These relative angles are not intended to be limiting but are instead intended to be exemplary. For instance, the articulation section <NUM> can be configured to adopt an articulation angle of up to between <NUM> and <NUM> degrees, or up to between <NUM> and <NUM>. Additionally or alternatively, in some examples, a length of the articulation section <NUM> can be varied to increase, decrease, or otherwise alter the number, shape, and configuration of the particular aspects or features facilitating articulation (e.g., no. of coils, helix pitch, slot width), and thereby alter the degree of passive articulation. For instance, an articulation section having a first quantity of helical coils arranged at a first pitch may provide a first degree of articulation, while an articulation section having a second quantity of helical coils arranged at the first pitch facilitates a second, greater degree of articulation. In various implementations, pitch values may range from <NUM> degrees to <NUM> degrees for example, although a variety of angles are contemplated.

In various examples, the coil/helical or slotted pattern can be cut into a tube to form the articulation section <NUM>. Alternatively, the coil/helical or slotted pattern can be formed or molded, as discussed herein. Adapting the articulation section <NUM> to bend, deflect, or otherwise deform provides that the articulation section <NUM> is transitionable between a generally linear state and a generally curved state. In various examples, the generally linear state is a steady state configuration of the articulation section <NUM>, where the articulation section <NUM> is not influenced to curve as a result of some external force acting on the system.

Configuring the articulation section <NUM> with one or more of a coil/helical or slotted cut pattern provides that one or more gaps or spaces exist between adjacent helical windings or adjacent slots. For instance, as shown in <FIG>, the gap <NUM> between the first helical winding <NUM> and the second helical winding <NUM> (e.g., adjacent helical windings) provides that the articulation section <NUM> can adopt a curvature, whereby the gap <NUM> in a first region of the helical winding (e.g., at a first angular position) is reduced in conjunction with the gap <NUM> in a second region of the helical winding (e.g., at a second angular position <NUM> degrees offset from the first angular position) is maintained or increased. Those of skill in the art should also appreciate that the decrease and/or increase in gap space is attributable, at least in part, to a deformation (e.g., bending) of one or more of the helical windings (e.g., <NUM> and <NUM>). In some examples, the articulation section <NUM> comprising the coil/helical or slotted pattern may be covered under at least one layer of flexible polymer such as a fluoropolymer material (e.g., an expanded polytetrafluoroethylene ("ePTFE"), expanded modified PTFE, or expanded copolymers of PTFE), nylons, polycarbonates, polyethylenes, polypropylenes, combinations of any of the foregoing, or other materials.

In various examples, the articulation section <NUM> may be configured to elastically deform under normal operating conditions (e.g., where the articulation section <NUM> is configured to elastically deform to accommodate a maximum expected articulation during a given endovascular procedure). By configuring the articulation section <NUM> to elastically deform under expected operating conditions (e.g., an expected degree of angulation), the embolic filter system provides that the filter <NUM> can be articulated relative to the elongate element <NUM> in a resilient manner such that the articulation section <NUM> resiliently returns to its linear state upon removal of the force required to cause the articulation. Such a configuration provides that the embolic filter system <NUM> is in linear alignment for collapse and removal following an endovascular procedure.

In other examples, the articulation section <NUM> may be configured to at least partially plastically deform under normal operating conditions (e.g., where the articulation section <NUM> is configured to at least partially deform to accommodate an expected articulation during a given endovascular procedure). By configuring the articulation section <NUM> to plastically deform under expected operating conditions (e.g., an expected degree of angulation), the embolic filter system provides that the filter <NUM> can be articulated relative to the elongate element <NUM> in a non-resilient manner such that a degree of angulation required can be established, whereby the operator is not required to continue inputting force to the elongate element <NUM> to maintain the desired relative articulation. Thus, a force can be input to the elongate element <NUM> to cause a desired degree of relative angulation between the filter <NUM> and the elongate element <NUM>, whereby the relative angulation is maintained as a result of plastic deformation of at least the articulation section <NUM> of the filter <NUM>. In some such examples, withdrawal of the embolic filter system <NUM> into a constraining catheter following an endovascular procedure causes the articulation section <NUM> to straighten, thereby causing re-alignment of the structural element <NUM> with the elongate element <NUM> for removal, such as through a catheter.

As mentioned above, the filter <NUM> may include one or more shape memory alloys, and thus may include one or more sections that are expandable. Thus, in various embodiments, the filter <NUM> is configured to transition between a delivery configuration and a deployed configuration, where one portion of the filter <NUM> is expanded relative to another portion of the filter <NUM>. For instance, in the delivery configuration, each of the various sections (e.g., the structural element <NUM>, the articulation section <NUM>, and the attachment section <NUM>) of the filter <NUM> exhibit a profile (e.g., a diameter) adapted for delivery through a patient's vasculature, such as through or within a delivery catheter as described further below. Conversely, in the deployed configuration, one or more of the various sections of the filter <NUM> are expanded relative to one or more of the other various sections of the filter <NUM>. As shown in <FIG>, the embolic filter system <NUM> is shown in a deployed configuration, where the structural element <NUM> is expanded relative to each of the articulation section <NUM>, the attachment section <NUM>, and the elongate element <NUM>. In some examples, the filter <NUM> is configured such that the structural element <NUM> is self-expandable. In other examples, however, the filter <NUM> is configured such that the structural element <NUM> is expandable through the use of an expansion aid (such as a balloon).

In various examples, the elongate element <NUM> is a longitudinally extending structure having a proximal end <NUM> and a distal end <NUM>. In some examples, the elongate element <NUM> is configured to receive blood and/or embolic debris that is directed into the embolic filter system <NUM> by the filter <NUM>. Accordingly, in some examples, the elongate element <NUM> includes a lumen. In various examples, the elongate element <NUM> is configured to be advanceable through the vasculature. Thus, the elongate element <NUM> is generally flexible yet longitudinally stable and compressible without risk of kinking or buckling under loading conditions consistent with advancement through vasculature, including advancement through one or more delivery catheters. In some examples, the elongate member <NUM> may include a braided, wrapped, or cut reinforcement member attached to a body portion of the elongate member <NUM> as a framework to add stability to the structure of the elongate member <NUM>. A reinforcement member may be braided by weaving a plurality of wire strands made of a suitable material. Regardless, the reinforcement member (e.g., the wire(s) or filament(s) forming the reinforcement member) may be made of metal and metal alloys (e.g., nitinol), polymeric materials, elastomeric materials, natural materials, or combinations of any of the foregoing. The reinforcement member may be symmetrically braided (e.g. with an opposing bias in an over/under configuration to form a typical braid) or having an asymmetric bias, with each strand of the braided wire oriented at a pitch angle ranging from <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, <NUM>° to <NUM>°, or any combination thereof, relative to a longitudinal axis of the braided wire.

The elongate element <NUM> may therefore comprise various materials including but not limited to medical grade polymeric materials including thermoplastic polymers, organosilicon polymers, and polyamides. Polyether block amide (e.g., PEBAXO), Nylon, polytetrafluoroethylene (PTFE), and Stainless steel are suitable non-limiting examples. The elongate element <NUM> may be formed according to known methods, such as extrusion. In some examples, the elongate element <NUM> may include one or more reinforcement elements, such as one or more fibers or braids extending along or within the material of the elongate element <NUM>. For instance, in some examples, the elongate element <NUM> may include coil reinforced Nylon or PEBAX.

In some examples, the elongate element <NUM> may be formed using a high durometer material, in which the hardness of the elongate element <NUM> may be from <NUM> to <NUM> Shore Hardness Units, <NUM> to <NUM> Shore Hardness Units, <NUM> to <NUM> Shore Hardness Units, <NUM> to <NUM> Shore Hardness Units, or any combination thereof. Such materials may include thermoplastics, for example but not limited to Polymethyl Methacrylate (PMMA or Acrylic), Polystyrene (PS), Acrylonitrile Butadiene Styrene (ABS), Polyvinyl Chloride (PVC), Modified Polyethylene Terephthalate Glycol (PETG), Cellulose Acetate Butyrate (CAB); Semi-Crystalline Commodity Plastics that include Polyethylene (PE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE or LLDPE), Polypropylene (PP), Polymethylpentene (PMP); Polycarbonate (PC), Polyphenylene Oxide (PPO), Modified Polyphenylene Oxide (Mod PPO), Polyphenylene Ether (PPE), Modified Polyphenylene Ether (Mod PPE), Thermoplastic Polyurethane (TPU); Polyamides such as nylon-<NUM> and nylon-<NUM>, Polyoxymethylene (POM or Acetal), Polyethylene Terephthalate (PET, Thermoplastic Polyester), Polybutylene Terephthalate (PBT, Thermoplastic Polyester), Polyimide (PI, Imidized Plastic), Polyamide Imide (PAI, Imidized Plastic), Polybenzimidazole (PBI, Imidized Plastic); Polysulfone (PSU), Polyetherimide (PEI), Polyether Sulfone (PES), Polyaryl Sulfone (PAS); Polyphenylene Sulfide (PPS), Polyetheretherketone (PEEK); Fluoropolymers that include Fluorinated Ethylene Propylene (FEP), Ethylene Chlorotrifluoroethylene (ECTFE), Ethylene, Ethylene Tetrafluoroethylene (ETFE), Polychlorotrifluoroethylene(PCTFE), Polyvinylidene Fluoride (PVDF), Perfluoroalkoxy (PFA), or combinations, copolymers, or derivatives thereof. Other commonly known medical grade materials include elastomeric organosilicon polymers and polyether block amide. In particular, polyamides can include nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>/<NUM>, and nylon <NUM>/<NUM>. In certain embodiments, PET, nylon, and PE may be selected for medical balloons used in high pressure applications. In some embodiments, the elongate element <NUM> may include a braid reinforced structure to improve burst pressure resistance. In some embodiments, the elongate element <NUM> may include one or more layers of hydrophilic coatings or other types of low-friction coatings and/or liners to reduce friction forces on the surface thereof. The specific choice of materials depends on the desired characteristics or intended application of the balloon.

The aforementioned reinforcement member may be combined with the high durometer material to form the elongate element <NUM> such that the body portion of the elongate element <NUM> is reinforced while the end of the elongate element <NUM> is inserted into the proximal end <NUM> of the filter <NUM>. In some examples, the high durometer material helps facilitate bonding of the end of the elongate element <NUM> to the proximal end <NUM> (e.g., by facilitating greater flow and mechanical engagement during heating and/or by increasing frictional/stiction engagement). In some examples, the bonding may be assisted using an adhesive, such as the UV cured adhesive as previously explained.

In some examples, blood and/or embolic debris entering the elongate element <NUM> flows through the lumen of the elongate element <NUM>, such as from the distal end <NUM> of the elongate element <NUM> to the proximal end <NUM> of the elongate element <NUM>. In some examples, one or more auxiliary systems <NUM> may be fluidly coupled with the lumen of the elongate element <NUM>, such as at the proximal end <NUM> of the elongate element <NUM>. In some such examples, such auxiliary systems <NUM> may be operable to aspirate the contents of the lumen (e.g., embolic debris and/or blood) of the elongate element <NUM>.

In some examples, the lumen of the elongate element <NUM> forms a working lumen through which one or more medical devices (e.g., guidewires, endoprostheses) can be passed to treatment areas proximate the embolic filter system <NUM>. Thus, in various examples, the lumen of the elongate element <NUM> operates as both a working lumen for medical device delivery as well as a structure for redirecting the flow embolic debris and/or blood. In some examples, the working lumen of the elongate element <NUM> may be in a range of 4Fr to 26Fr, or larger.

Examples of medical devices that may be passed through the lumen of the elongate element <NUM> include but are not limited to catheters, thrombectomy devices, atherectomy devices, embolectomy devices, and tools associated therewith, contrasting agents, drug delivery agents, endovascular prostheses including stents, stent-grafts, and valves, for example.

In various embodiments, the embolic filter system <NUM> includes a membrane disposed along one or more portions of the filter <NUM>, and optionally along one or more portions of the elongate element <NUM>. For example, as shown in <FIG>, a membrane <NUM> is disposed about an exterior of the structural element <NUM> and the articulation section <NUM> of the filter <NUM>. In these examples, by disposing the membrane <NUM> along the articulation section <NUM> and the structural element <NUM>, the membrane <NUM> operates to filter and retain embolic debris within the embolic filter system <NUM> that would otherwise be free to escape through the voids in the structural element <NUM> (e.g., the closed cells <NUM>) and the articulation section <NUM> (e.g., the gaps <NUM>). Accordingly, a configuration with the membrane <NUM> in combination with an articulation section (e.g., articulation section <NUM>) whose internal lumen is exposed is one that is operable to filter embolic debris from the blood while maintaining the ability to freely articulate the elongate element <NUM> relative to the filter <NUM> (and vice versa). In some examples, the portion of the membrane <NUM> extending along the articulation section <NUM> is blood impermeable.

Under certain conditions, the forces required to withdraw the embolic filter system <NUM> from the vasculature may be quite high (e.g., higher than the forces required to cause the articulation section <NUM> to bend to facilitate articulation between the filter <NUM> and the elongate element <NUM>). For instance, removal of the embolic filter system <NUM> may include withdrawing the embolic filter system <NUM> within a delivery catheter, which includes re-collapsing the deployed filter <NUM> whereby the distal end of the delivery catheter operates as a bearing surface that causes the filter <NUM> to radially collapse as the embolic filter system <NUM> is withdrawn into a lumen of the delivery catheter. As such, disposing a membrane <NUM> about the articulation section <NUM> operates to increase a tensile strength of the articulation section <NUM>. That is, a tensile strength of the combined membrane <NUM> and helically shaped/slotted material of the filter <NUM> exceeds the tensile strength of the helically shaped/slotted material of the filter <NUM>. And, while increasing the tensile strength of the articulation section <NUM> bears with it an ancillary effect of modifying the flexibility of the articulation section <NUM> (e.g., the degree to which the articulation section <NUM> can bend or articulate), such can be done while maintaining a sufficient degree of flexibility in the articulation section <NUM> to facilitate the desired degree of articulation between the filter <NUM> and the elongate element <NUM>.

It should be appreciated that the membrane <NUM> may additionally or alternatively be disposed about an interior of the structural element <NUM> and the articulation section <NUM>. In some examples, the membrane <NUM> may optionally extend to cover a portion of the overlapping sections of the elongate element <NUM> and attachment section <NUM> of the filter <NUM>.

In some examples, the membrane <NUM> operates to filter or otherwise condition the blood and embolic debris flowing into the embolic filter system <NUM>. In some examples, the membrane <NUM> is permeable to certain blood media (e.g., blood-permeable) and impermeable to certain other blood media and/or embolic debris. Specifically, in some examples, the membrane <NUM> is configured such that certain blood media (e.g., red blood cells, white blood cells, plasma, platelets, etc.) flowing into the embolic filter system <NUM> can permeate the membrane <NUM> of the filter <NUM> and re-enter the vasculature while the membrane <NUM> is impermeable to certain other blood media and embolic debris. In some examples, the membrane <NUM> is impermeable to embolic debris of a designated size or larger. That is, in some examples, the membrane <NUM> operates to obstruct embolic debris of a designated size or larger from permeating the membrane <NUM> of the filter <NUM> and re-entering the vasculature.

In some examples, the blood media and embolic debris flowing into the embolic filter system <NUM> that does not permeate back into the vasculature is either captured and retained within the filter <NUM> or is further directed into the elongate element <NUM>. In some examples, as explained in greater detail below, the filter <NUM> is collapsible such that blood media and embolic debris captured within the filter <NUM> can be subsequently removed with the removal of the embolic filter system <NUM> from the vasculature.

In some examples, blood and/or embolic debris that is directed into the elongate element <NUM> may be aspirated therefrom prior to removal of the embolic filter system <NUM> from the vasculature. Evacuating embolic debris that is captured within the filter <NUM> helps minimize the risk that the captured embolic debris will be unintentionally released back into the patient's vasculature during removal of the embolic filter system <NUM> from the patient's vasculature. For example, a known risk during embolic debris filtering procedures is the risk of tearing the membrane <NUM> of the filter <NUM> during removal. Embolic filters that are filled with embolic debris generally occupy a larger cross-sectional area than do embolic filters free of embolic debris. This increased cross section can be associated with difficultly in sufficiently collapsing the embolic filter to a configuration wherein the embolic filter can be completely retracted within a delivery catheter. Even where the filter is not retracted within a delivery catheter, withdrawing a filter having a larger diameter as a result of being filled with embolic debris through tortuous vasculature can be difficult.

The membrane <NUM> may comprise various materials including, but not limited to polymers such as fluoropolymers like an expanded polytetrafluoroethylene ("ePTFE"), expanded modified PTFE, expanded copolymers of PTFE, FEP, PFA, nylons, polyurethanes, polycarbonates, polyethylenes, polyester, silicone and silicone elastomers (e.g. SYLGARD™ <NUM>), urethane, thermoplastic polyurethane, polypropylenes, and the like.

In various examples, one or more regions of such materials may be further or alternatively modified by forming one or more perforations therein to control the permeability of the material. For example, a material such as an expanded fluoropolymer (or another suitable polymer) can be further modified by perforating one or more regions of the material to achieve a designated porosity. Examples include laser cutting or laser drilling holes or perforations into a material. Other materials having a woven, knitted or lattice configuration may also serve as adequate materials based on their permeability/porosity. Moreover, a desired permeability may be achieved through increasing or decreasing layers of the membrane material, as those of skill will appreciate. Additionally or alternatively, the permeability of the membrane <NUM> may be optimized by manipulating the microstructure of the membrane material. In some such instances, a node and fibril configuration of an expanded fluoropolymer can be modified/optimized to achieve desired permeability. For example, an expanded fluoropolymer can be processed such that a node and fibril configuration of the expanded fluoropolymer is generally impermeable to embolic debris (and other blood media) of a designated size consistent with the discussion below.

In some examples, the membrane material can be configured such that one or more portions or regions are permeable to a media up to a designated size while one or more other portions or regions are impermeable to the media of the designated size or larger. In some examples, the size of the pores or perforations (or voids in the node and fibril microstructure) present in the membrane material may vary, for example, from a proximal end to a distal end and/or at one or more discrete locations.

In various examples, the membrane <NUM> may be configured such that the membrane <NUM> is impermeable to embolic debris greater than or equal to about <NUM>. In some such examples, the average pore size (or perforation size or void size in the node and fibril microstructure of the membrane <NUM>) may be less than <NUM>. In other examples, the membrane <NUM> may be configured such that the membrane is impermeable to embolic debris smaller than <NUM>, such as embolic debris in the range of <NUM> to <NUM>. Such examples are not intended to be limiting. For instance, if desired, the membrane <NUM> may be configured to be permeable to embolic debris of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> (or larger), and anywhere therebetween, in which case an average pore size (or perforation size or void size in the node and fibril microstructure of the membrane <NUM>) may exceed <NUM>.

In various embodiments, the embolic filter system <NUM> is advanced to the treatment area within the vasculature in a delivery configuration, after which the embolic filter system <NUM> is operable to be deployed or otherwise transitioned to a deployed configuration. In the delivery configuration, the embolic filter system <NUM> is in a generally contracted configuration. In some examples, in the delivery configuration, the structural element <NUM> is radially contracted such that the structural element <NUM> is operable to be delivered endovascularly (e.g., at a small delivery profile), such as through a delivery catheter as discussed further below. In some examples, one or more of the articulation section <NUM>, the attachment section <NUM>, and one or more regions of the elongate element <NUM> may additionally be radially contracted, though the same is not required. In the deployed configuration, the structural element <NUM> is transitioned to a radially expanded configuration (e.g., <FIG>) operable to interrupt blood flow to cause embolic debris to be filtered therefrom. In some examples, one or more of the articulation section <NUM>, the attachment section <NUM>, and one or more regions of the elongate element <NUM> may additionally be radially expanded in the delivery configuration, though the same is not required.

After completion of the endovascular procedure, the embolic filter system <NUM> is operable to be removed from the vasculature. In some examples, embolic debris captured by the embolic filter system <NUM> may be aspirated or otherwise removed from the embolic filter system <NUM> prior to removal of the embolic filter system <NUM> from the vasculature, as mentioned herein. In some examples, to remove the embolic filter system <NUM>, the embolic filter system <NUM> is transitioned from the deployed configuration to the delivery configuration. In some examples, such a transition from the deployed configuration to the delivery configuration includes a contraction of one or more portions of the embolic filter system <NUM> (e.g., one or more portions of the filter <NUM> and the elongate element <NUM>). For instance, in various examples, removal of the embolic filter system <NUM> includes radially contracting or compressing the structural element <NUM> of the filter <NUM> to a profile (e.g., a diameter) conducive for endovascular removal. It is to be appreciated that a diameter of the structural element <NUM> is smaller when the embolic filter system <NUM> is in the delivery configuration that when the embolic filter system <NUM> is in the deployed configuration.

The embolic filter system <NUM> is operable to be delivered to treatment areas within the vasculature in association with a variety of different delivery methods. As such, the embolic filter system <NUM> is also operable to be assembled in a variety of different methods. The following discussion details various assembly and delivery methods associated with the embolic filter system <NUM>.

Turning now to <FIG>, a flow chart is illustrated that outlines one example method for a medical device assembly including the embolic filter system <NUM>. As shown, step <NUM> includes providing the embolic filter system <NUM>. As discussed above, the embolic filter assembly generally includes a filter <NUM> coupled with an elongate element <NUM>, wherein a membrane <NUM> extends along one or more portions of the filter <NUM> and optionally along one or more portions of the elongate element <NUM>. Step <NUM> includes providing a delivery catheter. In various examples, the delivery catheter may be a COTS delivery catheter, consistent with the discussion above. In various examples, the delivery catheter therefore includes an elongate element having a distal end and a proximal end, and a lumen extending therethrough from the proximal end to the distal end. A COTS delivery catheter <NUM> is shown in <FIG>, along with the embolic filter system <NUM>, including the filter <NUM>, the elongate element <NUM>, and the membrane <NUM>. The COTS delivery catheter <NUM> may optionally include one or more connectors, such as connector <NUM>, which may include a hemostasis valve or other element. It should be appreciated that the embolic filter system <NUM> is shown in <FIG> coiled up in a packaging configuration. As such, it will be appreciated that the embolic filter system <NUM> will be uncoiled prior to use.

Turning back now to <FIG>, at step <NUM>, the proximal end of the embolic filter system <NUM> is inserted into the lumen of the delivery catheter and proximally advanced through the lumen of the delivery catheter until the proximal end of the embolic filter system <NUM> extends proximal to the proximal end of the delivery catheter. For example, as shown in <FIG>, the proximal end <NUM> of the embolic filter system <NUM> has been inserted into the lumen of the delivery catheter <NUM> at the distal end <NUM> of the delivery catheter <NUM> and proximally advanced through the lumen of the delivery catheter <NUM> until the proximal end <NUM> of the embolic filter system <NUM> extends proximal to the proximal end <NUM> of the delivery catheter <NUM>.

Turning back now to <FIG>, at step <NUM>, the embolic filter system <NUM> is proximally withdrawn until the filter <NUM> is received within the lumen of the delivery catheter <NUM>. <FIG> illustrate the proximal withdrawal of the embolic filter system <NUM> relative to the delivery catheter <NUM>, where the embolic filter system <NUM> is withdrawn such that the filter <NUM> is partially received within the lumen of the delivery catheter <NUM> in <FIG>, and where the embolic filter system <NUM> is withdrawn such that the filter <NUM> is completely received within the lumen of the delivery catheter <NUM> in <FIG>.

With the filter <NUM> completely received within the lumen of the delivery catheter <NUM>, as shown in <FIG>, the delivery catheter <NUM> can be inserted into the vasculature of a patient and advanced to a treatment site therein, whereinafter the embolic filter system <NUM> can be advanced relative to the delivery catheter <NUM> (e.g., by one or more of distally advancing the embolic filter system <NUM> relative to the delivery catheter <NUM> and proximally withdrawing the delivery catheter <NUM> relative to the embolic filter system <NUM>) such that the filter <NUM> extends distally from the distal end <NUM> of the delivery catheter <NUM>. In some examples, as mentioned above, one or more portions of the filter <NUM>, such as the structural element <NUM>, are configured to radially expand to interrupt blood flow to filter embolic debris therefrom. For example, shown in <FIG> is the embolic filter system <NUM> being advanced distally relative to the delivery catheter <NUM> such that the filter <NUM> extends from the distal end <NUM> of the delivery catheter <NUM>. <FIG> shows a portion of the filter <NUM> extending from the distal end <NUM> of the delivery catheter <NUM>, and partially deployed (e.g., radially expanded), and <FIG> shows the filter <NUM> extending from the distal end <NUM> of the delivery catheter <NUM>, fully deployed (radially expanded). It will be appreciated that <FIG> are shown with the embolic filter system <NUM> and delivery catheter <NUM> outside of the body for clarity.

Turning now to <FIG> a flow chart is illustrated that outlines another example method for a medical device assembly including the embolic filter system <NUM>. As shown, step <NUM> includes providing the embolic filter system <NUM> as similarly discussed above with regard to step <NUM> of <FIG>. Step <NUM> includes providing a delivery catheter as similarly discussed above with regard to step <NUM> of <FIG>. Step <NUM> includes providing a constraining sheath, such as a COTS constraining sheath or a constraining sheath specifically designed for use in combination with the embolic filter system <NUM>. The constraining sheath may optionally be a constraining sheath that is splittable or that is otherwise configured to be torn-away from the embolic filter system <NUM> and the delivery system. <FIG> provides an illustration of a delivery catheter <NUM> with connector <NUM>, along with the embolic filter system <NUM>, and a constraining sheath <NUM>.

Turning back now to <FIG>, at step <NUM>, the proximal end of the embolic filter system <NUM> is inserted into the lumen of the constraining sheath and proximally advanced through the lumen of the constraining sheath <NUM> until the proximal end of the embolic filter system <NUM> extends proximal to the proximal end of the constraining sheath. For example, as shown in <FIG>, the proximal end <NUM> of the embolic filter system <NUM> has been inserted into the lumen of the constraining sheath <NUM> at the distal end <NUM> of the constraining sheath <NUM> and proximally advanced through the lumen of the constraining sheath <NUM> until the proximal end <NUM> of the embolic filter system <NUM> extends proximal to the proximal end <NUM> of the constraining sheath <NUM>.

Turning back now to <FIG>, at step <NUM>, the embolic filter system <NUM> is proximally withdrawn until the filter <NUM> is received within the lumen of the constraining sheath <NUM>. <FIG> illustrate the proximal withdrawal of the embolic filter system <NUM> relative to the constraining sheath <NUM>, where the embolic filter system <NUM> is withdrawn such that the filter <NUM> is partially received within the lumen of the constraining sheath <NUM> in <FIG>, and where the embolic filter system <NUM> is withdrawn such that the filter <NUM> is completely received within the lumen of the constraining sheath in <FIG>. In various examples, as described further below, the withdrawal of the embolic filter system <NUM> relative to the constraining sheath <NUM> may optionally be performed with the delivery catheter <NUM> inserted within the vasculature. In some examples, the withdrawal of the embolic filter system <NUM> relative to the constraining sheath <NUM> may also optionally be performed with a guidewire extending through one or more of the delivery catheter <NUM>, the embolic filter system <NUM>, and the constraining sheath <NUM>, as shown in <FIG>.

Additionally, in some examples, the elongate element <NUM> may have one or more visible markers on the proximal end (e.g. the end of the elongate element <NUM> that is being handled by the operator in <FIG>) and one or more visible markers on the distal end (e.g. proximate the filter <NUM>) such that the operator can see how far the filter <NUM> coupled to the distal end of the elongate element <NUM> is currently disposed within the patient's body by observing the position of each of the markers. In some examples, the proximal markers are visible to the unaided eye while the distal markers are visible under fluoroscopy (e.g., radiopaque). In some examples, one or both of the proximal and distal ends includes only one visible marker. In some example, the visible markers are located along a portion of the length of the elongate element <NUM> in the regular or varying increments (e.g., increments of <NUM>, <NUM>, <NUM>, <NUM>, or any other suitable increments as deemed useful for the operator). Similarly, visible markers may also be located on the opposite end of the elongate element <NUM> or along a length of the filter <NUM> and/or the articulation section <NUM>. As mentioned, in some examples, the visible markers located on the distal end are radiopaque markers made from materials such as high-visibility tantalum or other metals or alloys that are visible in fluoroscopic images. By using the markers located on either or both the proximal and distal ends, the operator can better understand the relative position of the filter <NUM> in the body of a patient.

Turning back now to <FIG>, at step <NUM>, the distal end of the constraining sheath is inserted into the lumen of the delivery catheter at the proximal end of the delivery catheter. For example, turning now to <FIG>, with the filter <NUM> of the embolic filter system <NUM> constrained within the lumen of the constraining sheath <NUM>, the distal end <NUM> of the constraining sheath <NUM> is inserted into the lumen of the delivery catheter <NUM> at the proximal end <NUM> of the delivery catheter <NUM>. In some example, this may include inserting the distal end <NUM> of the constraining sheath <NUM> into a connector of the delivery catheter <NUM>, such as connector <NUM>. <FIG> shows the constraining sheath <NUM> with the filter <NUM> of the embolic filter system <NUM> constrained therein being advanced toward the proximal end <NUM> of the delivery catheter <NUM>, and <FIG> shows the distal end <NUM> of the constraining sheath <NUM> inserted within the lumen of the delivery catheter <NUM> at the proximal end <NUM> of the delivery catheter <NUM>.

Turning back now to <FIG>, at step <NUM>, with the distal end of the constraining sheath inserted in the lumen of the delivery catheter at the proximal end of the delivery catheter, the embolic filter system <NUM> is distally advanced relative to the constraining sheath and the delivery catheter until the filter <NUM> is received within the lumen of the delivery catheter. For example, as shown in <FIG>, with the distal end <NUM> of the constraining sheath <NUM> inserted in the lumen of the delivery catheter <NUM> at the proximal end <NUM> of the delivery catheter, the embolic filter system <NUM> is distally advanced in the direction of arrow "A" relative to the constraining sheath <NUM> and the delivery catheter <NUM> until the filter <NUM> is received within the lumen of the delivery catheter <NUM>. <FIG> shows, in part, the embolic filter system <NUM> inserted into the lumen of the delivery catheter <NUM> such that the filter <NUM> is received within and constrained by the delivery catheter <NUM> in a delivery configuration (e.g., radially constrained).

Turning back now to <FIG>, after the filter <NUM> of the embolic filter system <NUM> is received within the lumen of the delivery catheter, the constraining sheath is removed in accordance with step <NUM>. In various examples, the constraining sheath <NUM> is removed from the lumen of the delivery catheter <NUM> during removal. In some examples, the constraining sheath <NUM> proximally advanced along and relative to the elongate element <NUM> of the embolic filter system <NUM> until the distal end <NUM> of the constraining sheath clears or translates to a position distal to the proximal end <NUM> of the embolic filter system <NUM>. However, in some examples, as mentioned above, the constraining sheath <NUM> is splittable or is otherwise configured to be torn away from the embolic filter system <NUM> and the delivery catheter <NUM>. Such splittable constraining sheaths may provide ease of removal where one or more connectors (e.g., Tuohy-Borst connector) are coupled to the elongate element <NUM> of the embolic filter system <NUM> proximal to the constraining sheath <NUM>. In some such examples, the splittable constraining sheath can be removed from the embolic filter system <NUM> and the delivery catheter <NUM> without requiring removal of the connector coupled to the elongate element <NUM> of the embolic filter system <NUM> proximal to the constraining sheath <NUM>.

An example removal of such a splittable constraining sheath <NUM> is shown in <FIG> and <FIG>, where the constraining sheath <NUM> is shown being split in to two sections for removal from the embolic filter system <NUM> and the delivery catheter <NUM>. <FIG> shows the embolic filter system <NUM> with the filter <NUM> completely received within the lumen of the delivery catheter <NUM>.

With the filter <NUM> completely received within the lumen of the delivery catheter <NUM>, as shown in <FIG>, the delivery catheter <NUM> can be inserted into the vasculature of a patient and advanced to a treatment site therein, whereinafter the embolic filter system <NUM> can be advanced relative to the delivery catheter <NUM> (e.g., by one or more of distally advancing the embolic filter system <NUM> relative to the delivery catheter <NUM> and proximally withdrawing the delivery catheter <NUM> relative to the embolic filter system <NUM>) such that the filter <NUM> extends distally from the distal end <NUM> of the delivery catheter <NUM>. As mentioned above, one or more portions of the filter <NUM>, such as the structural element <NUM>, are configured to radially expand to interrupt blood flow to filter embolic debris therefrom.

Turning now to <FIG> a flow chart is illustrated that outlines an example method for delivering a medical device including the embolic filter system <NUM> to a region within a patient's vasculature. As shown, steps <NUM> to <NUM> are consistent with steps <NUM> to <NUM> described above with respect to <FIG>. At step <NUM>, the delivery catheter is inserted into the vasculature of a patient and advanced until a distal end of the delivery catheter is positioned at a treatment area of the vasculature. Accordingly, it is to be appreciated that while the discussion above includes advancing the delivery catheter to a treatment area within a patient's vasculature after the embolic filter system <NUM> is received within the delivery catheter <NUM>, in some examples, the delivery catheter <NUM> may alternatively be inserted into the vasculature of the patient and advanced until a distal end of the delivery catheter is positioned at a treatment area of the vasculature prior to inserting the embolic filter system <NUM> into the delivery catheter <NUM>.

At step <NUM>, the distal end of the constraining sheath is inserted into the lumen of the delivery catheter at the proximal end of the delivery catheter. This step is largely consistent with step <NUM> of <FIG>, with the exception that step <NUM> is being performed with the delivery catheter in situ (i.e., while the delivery catheter is inserted within the patient's vasculature. Accordingly, reference is drawn to <FIG>, which illustrate the distal end <NUM> of the constraining sheath <NUM> being inserted into the lumen of the delivery catheter <NUM> at the proximal end <NUM> of the delivery catheter <NUM>. Those of skill should thus appreciate that the inventive concepts of the present disclosure provide for the ability to perform the step of inserting the constraining sheath into the lumen of the delivery catheter at the proximal end of the delivery catheter in situ or alternatively prior to advancement of the delivery catheter to the treatment area within the vasculature.

Such a versatile system provides that the embolic filter system <NUM> can be delivered to remote regions of the vasculature that might not be accessible with conventional systems. Such a system also provides that the embolic filter system <NUM> can be delivered to remote regions of the vasculature while minimizing trauma to the vasculature. For instance, those of skill will appreciate that the stiffness of a delivery catheter increases as additional components are received within its lumen. Relatively stiff delivery catheters may not be operable to navigate tortuous anatomy to reach certain regions of the vasculature and/or may traumatize the vasculature as a result of inflexibility. The embolic filter system <NUM> described herein provides that a relatively flexible delivery catheter can be first advanced to a treatment area within the vasculature (e.g., such as within or through a relatively tortuous region), without one or more additional components disposed therein that would otherwise operate to increase the stiffness of the delivery catheter. Moreover, such a configuration provides that the delivery catheter can operate as a protective boundary and bearing surface separating the embolic filter system <NUM> from the surrounding vasculature as the embolic filter system <NUM> is advanced to the treatment area.

Steps <NUM> and <NUM> are consistent with steps <NUM> and <NUM> described above with respect to <FIG>. Similarly, as illustrated and described above, it is to be appreciated that after the filter <NUM> of the embolic filter system <NUM> is advanced through the lumen of the delivery catheter to the treatment site, the embolic filter system <NUM> is operable to be deployed from the distal end of the delivery catheter (e.g., by one or more of distally advancing the embolic filter system <NUM> relative to the delivery catheter and proximally withdrawing the delivery catheter relative to the embolic filter system <NUM>) such that the filter <NUM> extends distally from the distal end of the delivery catheter and expands to interrupt blood flow to filter embolic debris therefrom.

The versatility of the embolic filter system <NUM> illustrated and descried herein also provides for ease of removal of the embolic filter system <NUM> from the vasculature and repositioning of the same in-situ. For example, during or subsequent to a deployment of the embolic filter system <NUM> within the vasculature, and operator can manipulate the angular relationship between the filter <NUM> and the elongate element <NUM> of the embolic filter system <NUM> to achieve a better alignment of the filter <NUM> with the vessel within which it is deployed. For instance, as mentioned above, the embolic filter system <NUM> is operable to have a relative articulation occur between the filter <NUM> and the elongate element <NUM> by way of an articulation section <NUM> bending or curving in response to advancement and retraction of the elongate element <NUM>. When the filter <NUM> is deployed within a vessel, one or more portions of the filter engage the vessel wall, thereby creating an engagement between the filter <NUM> and the vessel.

With the filter <NUM> engaged with the vessel, the elongate element <NUM> is operable to be advanced or retracted. Under certain conditions, advancement of the elongate element <NUM> with the filter <NUM> engaged, at least in part, with the vessel wall causes the embolic filter system <NUM> to undergo a compressive loading condition. In certain instances, such as those where the filter <NUM> is improperly aligned with the vessel in which it is deployed, such a compressive loading condition causes the articulation section <NUM> of the embolic filter system <NUM> to bend, thereby causing a relative articulation between the filter <NUM> (or at least a distal end thereof) and the elongate element <NUM>, as discussed above. Conversely, under certain conditions, retraction of the elongate element <NUM> with the filter <NUM> engaged, at least in part, with the vessel wall causes the embolic filter system <NUM> to undergo a tensile loading condition. In certain instances, such as those where the filter <NUM> misaligned with the elongate element <NUM>, such a tensile loading condition causes the articulation section <NUM> of the embolic filter system <NUM> to straighten, thereby causing a relative articulation between the filter <NUM> (or at least a distal end thereof) and the elongate element <NUM> such that the filter <NUM> and the elongate element <NUM> migrate toward alignment with one another. Thus, the elongate element <NUM> can be advanced and retracted to cause articulation between the filter <NUM> (or at least a distal end thereof) and the elongate element <NUM>, that can be utilized to achieve a proper alignment of the filter <NUM> within the vessel. It should be appreciated that proper alignment of the filter <NUM> within the vessel does not require alignment between the filter <NUM> and the elongate element <NUM>, and may require misalignment between the filter <NUM> and the elongate element <NUM>.

While the embolic filter system <NUM> of the various examples and illustrations described above includes a filter <NUM> having an articulation section <NUM> incorporated therein, in some alternative examples, the embolic filter system <NUM> may additionally or alternatively include one or more independent articulation elements that are positioned proximal to the filter <NUM> and that provide for articulation between the filter <NUM> and one or more portions of the elongate element <NUM>. That is, in some example, the embolic filter system <NUM> includes an articulation element that is independent of (e.g., not part of) the filter <NUM>. For instance, the filter <NUM> may include the structural element <NUM> without also including the articulation section <NUM>.

The articulation element in such examples may be consistent in form in function with the articulation section <NUM> of the filter <NUM> described above, with the exception that the articulation element is not an integral portion of the filter <NUM> but is instead an independent component that is coupled (either directly or indirectly) to one or more of the filter <NUM> and the elongate element <NUM>. Thus, in some examples, the articulation element includes a tubular construct that has been helically cut or slotted. As mentioned above, in those examples including a cut tube, the cuts in the tube to form the coil/helix or slotted segment extend through the thickness of the tube (e.g., from an exterior surface of the tube to the interior surface of the tube) such that the interior lumen of the tube is exposed. Such full thickness cuts in the tube provide gaps that can accommodate bending in one or more related portions of the tube (e.g., bending of one or more helical windings).

<FIG> shows an example articulation element <NUM>. As shown, the articulation element has a first end <NUM> and a second end <NUM>. The first and second ends <NUM> and <NUM> may be configured to interface with one or more of the filter <NUM> and the elongate element <NUM>. For instance, in some examples, the articulation element <NUM> may be incorporated into the embolic filter system <NUM> by coupling the first end <NUM> of the articulation element <NUM> to the proximal end <NUM> of the filter <NUM>, and by coupling the second end <NUM> of the articulation element <NUM> to the distal end <NUM> of (or a distal portion of) the elongate element <NUM>. In such examples, the articulation element <NUM> is positioned between the filter <NUM> and the elongate element <NUM> such that the filter <NUM> and the elongate element <NUM> are free to articulate relative to one another.

Additionally, as shown, the articulation element <NUM> includes a plurality of helical windings, such as helical windings <NUM> and <NUM>. In some examples, as mentioned above, the helical windings are formed in conjunction with cutting through a thickness of a tube in a helical pattern to create one or more helical windings. In various examples, adjacent helical windings are separated from one another by a helical gap <NUM>. As shown, the helical gap <NUM> exposes the lumen <NUM> of the articulation element <NUM>.

In various examples, and consistent with the discussion above, an embolic filter system, such as embolic filter system <NUM>, having the articulation element <NUM> in addition to, or in lieu of the articulation section <NUM> may be configured such that the membrane <NUM> extends along one or more of the exterior of the articulation element <NUM> and the interior luminal wall of the articulation element <NUM>. As such, the membrane <NUM> is operable to filter embolic debris, from blood escaping through the gap <NUM>. That is, the membrane <NUM> is operable to prevent embolic debris from escaping the embolic filter system through gap <NUM> in the articulation element <NUM>. In some examples, the membrane <NUM> may be blood impermeable in the region of the articulation element <NUM>.

In some embodiments, the elongate element <NUM> is configured such that its length can be easily modified in association with and endovascular procedure. For instance, in some examples, the elongate element <NUM> is operable to be cut such that a length of the elongate element can be modified from a first length, to a second shorter length. In some examples, the elongate element <NUM> is configured such that the length of elongate element <NUM> can be modified while the embolic filter system <NUM> is received within the lumen of the delivery catheter <NUM>. In some examples, an attachable/detachable hub is coupled to the proximal end of the elongate element <NUM> to fluidly seal the lumen of the delivery catheter <NUM>. For example, the hub may have a Luer taper connection, a hose barb connection, or a combination thereof (e.g., Luer-to-barb fitting connection) as used to form a leak-free connection at the proximal end of the elongate element <NUM>, as suitable. In some examples, the hub may be permanently attached or coupled to the proximal end of the elongate element <NUM> and in others the hub may be removably attached thereto.

In some examples, the elongate element <NUM> includes a plurality of predetermined sections that are configured to be removed. For instance, in some examples, the elongate element <NUM> includes a first removable section and a second removable section, such that either one or both of the first and second removable sections can be removed to modify the length of the elongate element from the first length to the second shorter length. In some examples, the removable sections may be configured to be removed by way of cutting. In some other examples, the removable sections may be configured to be additionally or alternatively removed by way of twisting, bending, or pulling the removable section relative to the remainder of the elongate element <NUM>.

In some examples, one or more portions or components of the embolic filter system <NUM>, such as the elongate element <NUM>, may be color-coded to indicate a diameter of the elongate element <NUM>, wherein a first color indicates a first diameter (e.g., 6Fr) and wherein a second color indicates a second different diameter. Such color-coding can help users identify a proper diameter for used with a COTS delivery catheter in association with an endovascular procedure.

It should be appreciated that the configurations discussed herein are scalable in that they can be scaled up or scaled down for different applications. That is, while certain of the configurations discussed herein are illustrated and described in association with placement within the aortic arch, for example, the versatility of the system provides for implementation in virtually any other area of the patient's vasculature. For example, the various configurations discussed herein may be scaled for application within various peripheral vessels and lumens such as the brachiocephalic artery, and/or the carotid artery, and/or the subclavian artery. Likewise, as it relates to the aortic arch, the present disclosure can be used in connection with femoral, transapical and thoracotomy approaches. Moreover, this disclosure should not be interpreted as limiting application to the vessels proximate the heart. For instance, the devices and systems described herein may be implemented throughout the vasculature of the body including vasculature above and below the heart to prevent the migration of embolic debris during various other revascularization procedures. Additionally, the embodiments can be used in connection with not just humans, but also various organisms having mammalian anatomies. Thus, it is intended that the embodiments described herein cover the modifications and variations within the scope of this disclosure. As such, the embolic filter system <NUM> may be formed in a variety of different sizes, which may optionally be based on COTS delivery catheter sizes such that the embolic filter system <NUM> can be produced in a variety of sizes that can be used in association with the variety of sized of COTS delivery catheters. As mentioned above, one or more components of the embolic filter system <NUM> may be color coded based on such sizing.

Claim 1:
A medical device (<NUM>) comprising:
an elongate element (<NUM>) having a first end (<NUM>) and a second end (<NUM>); and
an embolic filter assembly (<NUM>) comprising a frame having an attachment section (<NUM>), a capture section (<NUM>) distal to the attachment section (<NUM>), and an intermediate section (<NUM>) between the attachment section (<NUM>) and the capture section (<NUM>), the attachment section (<NUM>) of the embolic filter assembly (<NUM>) being coupled to the elongate element (<NUM>) at one of the first (<NUM>) and second ends (<NUM>), wherein the intermediate section (<NUM>) is adapted to allow for relative articulation between the capture section (<NUM>) of the frame and the attachment section (<NUM>) of the frame, and wherein the intermediate section (<NUM>) of the frame is tubular and the attachment section (<NUM>), the capture section (<NUM>), and the intermediate section (<NUM>) are formed of the same material.