Embolic filter with bends

Abstract

To provide a good embolic filter system and the like.SOLUTION: The described embodiments relate to embolic filter systems. The embolic filter system generally includes an elongate element having a first end and a second end, the embolic filter assembly comprising a frame having a capturing section distal of an attachment section, the capturing section including a plurality of strut elements arranged to form a plurality of cells having cell ends, and at least one bending element operably coupled to and between the cell ends of two adjacent cells of the plurality of cells such that the frame is operable to bend between the cell ends.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Patent Application No. 63 / 137385, filed January 14, 2021, which is incorporated herein by reference in its entirety for all purposes.

[0002] International Patent Application No. PCT / US2019 / 056737, filed October 17, 2019, which claims the benefit of U.S. Provisional Patent Application No. 62 / 747,026, filed October 17, 2018 (inventors William Montgomery and Edward Shaw), is incorporated herein by reference in its entirety for all purposes. [Background technology]

[0003] Intravascular procedures address a wide range of medical needs, including intravascular access, diagnosis, and / or repair, through minimally invasive or less invasive than surgical procedures. During some endovascular procedures, embolic debris may become dislodged or circulate within the vessels. Circulating embolic debris can cause mild to severe cardiovascular complications, leading to heart attack or even death.

[0004] Embolic protection devices have been developed and used in connection with various intravascular procedures to mitigate the risks associated with such procedures. Some embolic protection devices act to capture embolic debris and filter it from the blood. 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 capture embolic debris within the embolic protection device such that the embolic debris is retained by the embolic protection device when the embolic protection device is removed from the vessel. However, a common risk of these procedures is that some or all of the captured embolic debris may be unintentionally released back into the vessel during the removal process.

[0005] Proper orientation of an embolic protection device within a vessel is an important factor in facilitating embolic capture and removal. However, while conventional devices can be deployed within tortuous vessels, some lack a means for orienting or repositioning the device within the vessel after deployment. Poor orientation of an embolic protection device can allow embolic debris to bypass the embolic protection device due to one or more gaps between the embolic protection device and the vessel wall and / or because the embolic debris is not completely captured by the embolic protection device, resulting in the unintended release of embolic debris into the bloodstream upon removal of the embolic protection device from the vessel. Proper orientation is particularly challenging in tortuous body anatomy. Summary of the Invention

[0006] According to a first embodiment ("Example 1"), a medical device includes an embolic filter assembly having an elongated element having a first end and a second end, and a frame having a capture section distal to the mounting section, the capture section including a plurality of strut elements arranged to form a plurality of cells having cell ends, and at least one bending element operably coupled therebetween between the cell ends of two adjacent cells of the plurality of cells such that the frame is operable to bend between the cell ends.

[0007] According to another embodiment ("Embodiment 2") in addition to Embodiment 1, the capture section is radially expandable relative to the mounting section such that the embolic filter assembly is configured to transition from a compressed state to an expanded state in situ.

[0008] According to another embodiment ("Example 3") in addition to Examples 1 or 2, the capture section includes a seal establishment zone operable to establish a seal with the patient's tissue and a bending zone operable to bend to conform to the shape of the patient's tortuous internal tissue structure.

[0009] According to another embodiment ("embodiment 4") in addition to embodiment 3, the flexing element defines a flexing zone in which the frame has greater flexibility than adjacent portions of the frame.

[0010] According to another embodiment ("embodiment 5") in addition to any of embodiments 1-4, the frame is configured such that the capture section is self-expanding.

[0011] According to another embodiment ("embodiment 6") in addition to any of embodiments 1-5, the frame includes a metal material.

[0012] According to another embodiment ("embodiment 7") in addition to embodiment 6, the metallic material includes nitinol.

[0013] According to another embodiment ("Embodiment 8") in addition to any of Embodiments 1-7, the frame is of unitary construction such that the mounting section and the capture section are formed by a single monolithic component.

[0014] According to another embodiment ("embodiment 9") in addition to any of embodiments 1-8, the bending element is serpentine having at least one curve in a first direction and at least one curve in a second direction opposite the first direction.

[0015] According to another embodiment ("embodiment 10") in addition to any of embodiments 1-9, the strut elements have a square, a rectangle, a trapezoid, a rounded square, a rounded rectangle, or a rounded trapezoid.

[0016] According to another embodiment ("Example 11") in addition to Example 10, the cut tube is a laser cut tube.

[0017] According to another embodiment ("embodiment 12") in addition to embodiment 9 or 10, the frame includes a spiral-shaped middle section.

[0018] According to another embodiment ("embodiment 13") in addition to any of embodiments 1-12, the plurality of cells are closed quadrilateral cells.

[0019] According to another embodiment ("Example 14") in addition to Example 13, each of the plurality of closed cells includes a first vertex and a second vertex opposite the first vertex.

[0020] According to another embodiment ("Example 15") in addition to Example 14, at least one bending element is operably coupled between a proximal apex of a first closed cell of the plurality of closed cells and a distal apex of a second closed cell of the plurality of closed cells.

[0021] According to another embodiment ("Example 16") in addition to Example 14, a plurality of closed cells form a first cell row and a second cell row along the longitudinal length of the frame, and each distal apex of the plurality of closed cells of the first cell row is operably coupled to each proximal apex of the plurality of closed cells of the second cell row via a bending element.

[0022] According to another embodiment ("Embodiment 17") in addition to any of Embodiments 1-16, at least one bending element is adapted to bend at multiple bending points between the first and second ends of the bending element.

[0023] According to another embodiment ("embodiment 18") in addition to any of embodiments 1-17, at least one bending element is adapted to extend in length.

[0024] According to another embodiment ("Example 19") in addition to Example 3, the frame defines a longitudinal axis, and the frame is operable to flex at the flex zone such that the longitudinal axis is non-linear when the flex zone of the frame flexes.

[0025] According to another embodiment ("Embodiment 20") in addition to Embodiments 1-19, the frame is adjustably deployable such that at least one bending element is operable to partially mechanically separate the plurality of closed cells from one another during expansion of the frame element.

[0026] According to a second embodiment ("Example 21"), an embolic filter assembly for deployment within a patient's lumen includes a frame arranged about a longitudinal axis and operable to expand from a smaller collapsed configuration to a larger expanded configuration, the frame including a plurality of frame elements defining a sealing section and a capture section, the sealing section configured to interface with the patient's lumen, the capture section including a bending element positioned between the frame elements within the capture zone, and the frame operable to bend away from the longitudinal axis at the bending element more than an adjacent portion of the frame not having the bending element.

[0027] According to another embodiment ("Embodiment 22") in addition to Example 21, the bending elements are aligned around the circumference of the frame at a common longitudinal position along the length of the frame.

[0028] According to another embodiment ("Embodiment 23") in addition to Embodiment 21, the embolic filter assembly further includes a filter element coupled to the frame.

[0029] According to another embodiment ("Example 24") in addition to Example 21, the frame is operable to be partially deployed such that the sealing section is operable to expand to an expanded diameter while at least a portion of the capture section is maintained at a collapsed diameter.

[0030] According to another embodiment ("Example 25") in addition to Example 24, the acquisition section is operable to filter fluid flowing through the acquisition section when the acquisition section is partially deployed.

[0031] According to another embodiment ("embodiment 26") in addition to embodiment 21, the frame is configured to allow delivery of a secondary device.

[0032] According to another embodiment ("Example 27") in addition to Example 21, the frame is operable to angulate at the bending element to maintain the frame in an orthogonal orientation within the lumen when deployed.

[0033] According to another embodiment ("Example 28") in addition to Example 27, the bending element comprises a curved, bent, zigzag, snake, or coil shape.

[0034] According to another embodiment ("embodiment 29") in addition to embodiment 21, the frame element forms a plurality of closed cells, each closed cell including a proximal apex and a distal apex.

[0035] According to another embodiment ("Example 30") in addition to Example 29, the first bending element is operably coupled between a proximal apex of a first closed cell of the plurality of closed cells and a distal apex of a second closed cell of the plurality of closed cells.

[0036] According to another embodiment ("Example 31") in addition to Example 29, a plurality of closed cells form a first cell row and a second cell row along the longitudinal length of the frame, and each distal apex of the plurality of closed cells of the first cell row is operably connected to each proximal apex of the plurality of closed cells of the second cell row via a bending element.

[0037] According to another embodiment ("Example 32") in addition to Example 29, the frame is adjustably expandable such that the bending elements are operable to partially mechanically separate the plurality of closed cells from one another.

[0038] According to a third embodiment ("Example 33"), an embolic filter assembly for deployment in a patient's lumen includes a frame arranged about a longitudinal axis and operable to expand from a smaller collapsed configuration to a larger expanded configuration, the frame including a plurality of frame elements defining a sealing section and a capturing section, the sealing section configured to interface with the patient's lumen, the capturing section including a bending element positioned between the frame elements within the capturing zone, and the frame operable to be partially deployed such that the sealing section is operable to expand to an expanded diameter when at least a portion of the capturing section is maintained at the collapsed diameter.

[0039] While multiple embodiments are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. Accordingly, the drawings and detailed description are to be regarded as illustrative and not restrictive. [Brief explanation of the drawings]

[0040] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated into and constitute a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the disclosure.

[0041] [Figure 1] FIG. 1 is a diagram of an embolic filter frame, according to some embodiments.

[0042] [Figure 2] FIG. 2 is an illustration of an unexpanded cut embolic filter frame, according to some embodiments.

[0043] [Figure 3] FIG. 3 is a diagram of a frame and filter of an embolic filter system, according to some embodiments.

[0044] [Figure 4A] FIG. 4A is a diagram of an embolic filter frame when bending and a close-up of a bending element of the embolic filter frame according to some embodiments. [Figure 4B] FIG. 4B is a diagram of the embolic filter frame when bent and a close-up of the bending element of the embolic filter frame, according to some embodiments.

[0045] [Figure 5] FIG. 5 is a flowchart of a method of assembling an embolic filter system, according to some embodiments.

[0046] [Figure 6A] FIG. 6A is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 6B] FIG. 6B is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 6C] FIG. 6C is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 6D] FIG. 6D is an illustration of a method of assembling an embolic filter system according to some embodiments.

[0047] [Figure 6E] FIG. 6E is an illustration of a method of deploying an embolic filter system, according to some embodiments. [Figure 6F] FIG. 6F is an illustration of a method of deploying an embolic filter system, according to some embodiments.

[0048] [Figure 7] FIG. 7 is a flowchart of a method of assembling an embolic filter system, according to some embodiments.

[0049] [Figure 8A] FIG. 8A is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8B] FIG. 8B is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8C] FIG. 8C is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8D] FIG. 8D is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8E] FIG. 8E is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8F] FIG. 8F is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8G] FIG. 8G is an illustration of a method of assembling an embolic filter system, according to some embodiments. [Figure 8H] FIG. 8H is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8I] FIG. 8I is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8J] FIG. 8J is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8K] FIG. 8K is an illustration of a method of assembling an embolic filter system according to some embodiments. [Figure 8L] FIG. 8L is an illustration of a method of assembling an embolic filter system according to some embodiments.

[0050] [Figure 9] FIG. 9 is a flowchart of a method of implanting an embolic filter system, according to some embodiments.

[0051] [Figure 10A] FIG. 10A is a diagram of a bending element according to some embodiments. [Figure 10B] FIG. 10B is a diagram of a bending element according to some embodiments. [Figure 10C] FIG. 10C is a diagram of a bending element according to some embodiments.

[0052] [Figure 11] FIG. 11 is a diagram of an embolic filter frame with bending elements along the struts of the embolic filter.

[0053] [Figure 12] FIG. 12 is a diagram of the embolic filter of FIG. 12, which includes a sealing portion that is fully deployed and a filter portion that remains partially constrained. DETAILED DESCRIPTION OF THE INVENTION

[0054] The present disclosure is not intended to be limiting. For example, the terms used in this application should be interpreted broadly in the context of the art to which they pertain.

[0055] Those skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by a variety of methods and apparatus configured to perform the intended functions. In other words, other methods and apparatus can be incorporated herein to perform the intended functions. Also, the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in this sense the drawings should not be construed as limiting.

[0056] Certain relative terms are used to indicate the relative positions of components and features. For example, "top," "bottom," "upper," "lower," "left," "right," "horizontal," "vertical," "upward," and "downward" are used in a relative rather than absolute sense (e.g., how components or features are positioned relative to one another) unless the context dictates otherwise. Similarly, throughout this disclosure, when processes or methods are shown or described, the methods can be performed in any order or simultaneously, unless it is clear from the context that the method is dependent on a particular act being performed first.

[0057] With respect to uncertainty terminology, "approximately" and "about" can be used interchangeably to mean a value that includes the specified value and any value that is reasonably close to the specified value. A value that is reasonably close to a specified value deviates from the specified value by a reasonably small amount as would be understood and readily ascertained by one of ordinary skill in the art. Reasonable deviations can result, for example, from measurement error, variations in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, adjustments made to optimize performance and / or structural parameters to account for variations in measurements associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulation of objects by humans or machines, etc.

[0058] As used herein, "couple" means to join, connect, attach, adhere, fasten, or adhere, whether directly or indirectly, and whether permanently or temporarily.

[0059] As used herein, "elastomer" means a polymer or mixture of polymers that has the ability to be stretched to at least 1.3 of its original length and to rapidly retract to approximately its original length upon release. "Elastomeric material" means a polymer or mixture of polymers that exhibits stretch and recovery properties similar to elastomers, although not necessarily to the same extent. "Non-elastomeric material" means a polymer or mixture of polymers that exhibits stretch and recovery characteristics not similar to elastomers or elastomeric materials, i.e., that are not considered elastomers or elastomeric materials as commonly known.

[0060] Various aspects of the present disclosure relate to embolic filter devices, systems, and methods. An exemplary embolic filter system 1000 is illustrated in FIG. 1. Embolic filter system 1000 generally includes filter 1100 and elongate element 1200. In various embodiments, embolic filter system 1000 is configured to allow filter 1100 and elongate element 1200 to freely articulate relative to one another (e.g., up to a 45-degree bend between elongate element 1200 and filter 1000). As discussed further below, in some embodiments, filter 1100 includes one or more features that facilitate relative articulation along the longitudinal length of filter 1100. Articulation along filter 1100 facilitates deployment of filter 1100 within tortuous or otherwise challenging body structures (e.g., lumens such as arteries or blood vessels). In some embodiments, filter 1100 includes one or more features that facilitate articulating movement along the length of filter 1100, while in other embodiments, embolic filter system 1000 includes one or more additional components, such as one or more elements that facilitate relative articulating movement along the length of filter 1100. Providing embolic filter system 1000 with filter 1100 actuatable for articulating movement along the length of filter 1100 allows embolic filter system 1000 to be passively oriented to properly align filter 1100 with respect to the vessel in which it is partially or fully deployed. Alternatively, embolic filter system 1000 can be manipulated in situ by an operator for this alignment.

[0061] 1 , embolic filter system 1000 includes a first end 1002 and a second end 1004. In some embodiments, filter 1100 extends distally from elongate element 1200 such that first end 1102 of filter 1100 at least partially defines first end 1002 of embolic filter system 1000. Similarly, in some embodiments, elongate element 1200 includes first end 1202 and a second end 1204, and elongate element 1200 extends from filter 1100 such that second end 1204 of elongate element 1200 at least partially defines second end 1004 of embolic filter system 1000. In various embodiments, second end 1104 of filter 1100 is coupled to elongate element 1200. In some embodiments, second end 1104 of filter 1100 is coupled to first end 1202 of elongate element 1200. In some embodiments, coupling second end 1104 of filter 1100 to first end 1202 of elongate element 1200 comprises coupling second end 1104 of filter 1100 to first end 1202 of elongate element 1200 such that first end 1202 of elongate element 1200 is located distal to second end 1104 of filter 1100 (e.g., such that filter 1100 and elongate element 1200 partially overlap one another).

[0062] In various embodiments, embolic filter system 1000 can be used in combination with one or more auxiliary systems. For example, as shown in FIG. 1 , one or more auxiliary systems 2000, including one or more auxiliary components, can be utilized in combination with embolic filter system 1000. In some embodiments, auxiliary system 2000 and / or its components can be commercial off-the-shelf (COTS) systems or components. One non-limiting auxiliary system 2000 is a COTS catheter. Other non-limiting auxiliary systems 2000 include constraining sheaths, including peel-away sheaths, valves and connectors (e.g., Tuohy-Borst Connectors), and control handles, such as those used in controlling backflow of fluids through embolic filter system 1000 and one or more of auxiliary systems 2000. Auxiliary systems 2000 can be used in connection with one or more of the delivery, deployment, operation, and / or removal of embolic filter system 1000. In various embodiments, the embolic filter system 1000 can itself include one or more of such tear-away sheaths, connectors, and / or valves, such as hemostatic valves.

[0063] Embolic filter system 1000 is generally configured to be advanced to a target site within a patient's vasculature such that one or more components of embolic filter system 1000 (e.g., filter 1100) are antegrade or "downstream" of the treatment area of ​​the vasculature, between the treatment area and one or more body tissue regions where the presence of embolic debris could cause complications and harm to body tissue structures. Those skilled in the art will appreciate that positioning the system downstream from the treatment area will allow emboli and other debris dislodged from the treatment area during treatment to travel with the blood flow toward embolic filter system 1000, where the embolic debris can be filtered from the blood.

[0064] Proper orientation of filter 1100 of embolic filter system 1000 within a blood vessel or vascular region is an important factor in facilitating proper deployment and successful filtration of embolic debris from the blood in connection with an intravascular procedure. However, in certain portions of a vessel and / or under certain conditions, it can be difficult to deploy an embolic filter in a manner that is operable to successfully filter embolic debris from the blood. The embolic filter system 1000 disclosed herein passively aligns itself along a vascular surface, such as a vessel wall, and relatively articulates along the length of filter 1100 to properly align filter 1100 within the vessel. Alignment within the vessel generally minimizes gaps between filter 1100 and the vessel wall, which could act as a passageway for embolic debris to bypass embolic filter system 1000. However, in some embodiments, embolic filter system 1000 provides the operator with the ability to manipulate embolic filter system 1000 to deploy embolic filter system 1000 and properly align filter 1100 with the vessel.

[0065] In various embodiments, articulation is achieved by advancing and retracting elongate element 1200 one or more times while filter 1100 is partially deployed. For example, advancing and / or retracting elongate element 1200 while filter 1100 is partially deployed within the vessel can be operable to impart a compressive or tensile load to one or more of filter 1100 and elongate element 1200. As discussed above, in various embodiments, filter 1100 can include one or more features that facilitate relative articulation along the length of filter 1100; however, in other embodiments, embolic filter system 1000 includes one or more additional components, such as one or more elements that facilitate relative articulation along the length of filter 1100. In various embodiments, upon application of a compressive and / or tensile load, the embolic filter system 1000 bends, deflects, or deforms one or more features and / or one or more additional components of the filter 1100 to allow relative articulating movement along the length of the filter 1100.

[0066] When deployed, embolic filter system 1000 interacts with blood flowing through the region of the vessel in which embolic filter system 1000 is deployed. In some embodiments, embolic filter system 1000 is adapted or configured to filter blood and / or embolic debris as blood flows through or interacts with embolic filter system 1000. In some embodiments, embolic filter system 1000 additionally or alternatively redirects blood flow and / or embolic debris from what would be the normal or unimpeded flow of blood and / or embolic debris through the surrounding vessel. Thus, in various embodiments, embolic filter system 1000 can be deployed within a region of the patient's vessel such that blood and / or embolic debris is filtered and / or redirected as it flows through the region of the patient's vessel.

[0067] 1 and 2, filter 1100 of embolic filter system 1000 includes a body 1106 having a first end 1002 and a second end 1004. Filter 1100 generally includes structural elements forming a capture section 1108, an attachment section 1114, and an articulation section 1118. In some embodiments, articulation section 1118 may be referred to as an intermediate section because it is intermediate first end 1102 and second end 1104. FIG. 2 is a two-dimensional plan view of filter 1100, unfolded and flattened to illustrate the relationship between capture section 1108, attachment section 1114, and articulation section 1118, showing the full circumference of filter 1100.

[0068] In various embodiments, filter 1100 is a structure configured to interact with blood and / or embolic debris flowing through a patient's vasculature in the region in which embolic filter system 1000 is deployed. As discussed in more detail below, filter 1100, or one or more portions thereof, can be formed from cut tubing, a wire frame, cast or injection molded parts, or combinations thereof. In some embodiments, one or more portions of filter 1100 can be formed from a shape-memory material, such as nitinol, such that the one or more portions have or exhibit self-expanding properties, as will be appreciated by those skilled in the art. However, in other embodiments, one or more of the components of filter 1100 can be formed from other resilient materials that are expandable using an expansion aid (e.g., a balloon). For example, one or more of the support elements can be formed from a polymer or a biocompatible alloy, such as stainless steel. In some embodiments, filter 1100, or one or more portions thereof, can be constructed from a durable elastomeric material, such as polyurethane or compressed nylon.

[0069] 1 and 2, filter 1100 includes a capture segment 1108 (also referred to herein as a structural element). Capture segment 1108 is configured to direct or pass blood and embolic debris into an interior region of filter 1100 and, in some embodiments, into elongate element 1200. Thus, capture segment 1108 acts as a blood flow obstacle, forcing blood to interact with embolic filter system 1000 before flowing downstream of embolic filter system 1000. In various embodiments, capture segment 1108 is configured to transition between a contracted configuration (e.g., FIG. 2) and an expanded configuration (e.g., FIG. 1) in conjunction with embolic filter system 1000 transitioning from a delivery configuration to a deployed configuration, such that embolic filter system 1000 can be delivered intraluminally (e.g., at a small delivery profile) while still having the ability to be deployed in situ to a larger deployment profile to pause blood for filtering embolic debris from the blood.

[0070] In the deployed configuration, filter 1100 is generally trumpet-, conical-, or frusto-conical-shaped, with the cross-sectional area of ​​filter 1100 varying at two different longitudinal locations along filter 1100 between first end 1102 and second end 1104 of filter 1100. In some embodiments, the cross-sectional area of ​​first end 1102 is greater than the cross-sectional area of ​​second end 1104. In some embodiments, filter 1100 is generally tapered from first end 1102 to second end 1104, as shown, for example, in FIGS. 1 and 3 . Such a configuration enables filter 1100 to operate to pass blood through filter 1100 and / or through elongate element 1200, as disclosed herein.

[0071] In various embodiments, the acquisition section 1108 is comprised of one or more support elements, such as one or more strings, meshes, lattices, wires, rings, struts, or other suitable support elements. For example, as shown in Figures 1 and 2, the acquisition section 1108 includes a plurality of strut elements 1110 arranged to form one or more closed cells 1112 that collectively at least partially define the acquisition section 1108. As shown, these closed cells 1112 are arranged in one or more rows (e.g., 1, 2, 3, 4, or more than four rows). However, strings, meshes, lattices, wires, rings, and other suitable support elements can be used in place of or in combination with the strut elements 1110, so long as the acquisition section 1108 of the filter 1100 is operable to transition from a contracted configuration to an expanded configuration.

[0072] In some embodiments, the closed cells 1112 are configured to change shape to accommodate or facilitate a transition between the expanded and contracted configurations of the structural elements of the capture section 1108. For example, when the structural elements of the capture section 1108 are in the expanded configuration, the closed cells can be quadrilateral (e.g., diamond-shaped) as shown in Figure 1. However, it will be appreciated that the shapes of the closed cells illustrated herein should not be construed as limiting, and various other shapes (e.g., polygonal) and / or sizes are contemplated.

[0073] Additionally, the examples shown herein should not be construed as limiting, as the number of rows of closed cells and / or the number of closed cells per row can be increased or decreased to achieve a desired expansion profile (e.g., deployed diameter) and a desired collapsed profile (e.g., delivery diameter). Generally, for a given closed cell size and shape, increasing the number of closed cells 1112 increases the expanded and collapsed profile diameters, while decreasing the number of closed cells 1112 decreases the expanded and collapsed profile diameters. Similarly, for a given cell size and shape and number of closed cells 1112 per row, increasing the number of rows of closed cells 1112 increases the length of the filter 1100, while decreasing the number of rows of closed cells 1112 decreases the length of the filter 1100.

[0074] In some embodiments, the closed cells 1112 comprise a substantially elongated shape when the filter 1100 is in an expanded configuration (e.g., substantially diamond-shaped). Each closed cell 1112 comprises an apex 1113 that defines the furthest distance apart of the closed cell 1112 in a given direction. For example, when the closed cells 1112 are substantially diamond-shaped, each closed cell comprises a first longitudinal apex 1113a, a second longitudinal apex 1113b, a first lateral apex 1113c, and a second lateral apex 1113d. The first and second lateral apexes 1113c and 1113d represent the boundaries of closed cells 1112 within the same row, and the first and second longitudinal apexes 1113a and 1113b represent where a closed cell 1112 abuts a corresponding closed cell in an adjacent row, if an adjacent row exists. By way of example, the filter 1100 includes multiple rows of closed cells 1112, such as a first row 1115a and a second row 1115b. The first row 1115a includes a first closed cell 1112a, and the second row 1115b includes a second closed cell 1112b. Each of the closed cells 1112a, 1112b has a first longitudinal apex 1113a and a second longitudinal apex 1113b, where the first longitudinal apex 1113a is closer to the first end 1102 than the second longitudinal apex 1113b and the second end 1104, and the second longitudinal apex 1113b is closer to the second end 1104 than the first longitudinal apex 1113a and the first end 1102. The first closed cell 1112a is adjacent to the second closed cell 1112b along the longitudinal length of the filter 1100. The second longitudinal apex 1113b of the first closed cell 1112a is positioned adjacent to the first longitudinal apex 1113a of the second closed cell 1112b.

[0075] In various embodiments, the capture section 1108 includes one or more features configured to facilitate bending of the filter 1100 along its longitudinal length. These features define a bending zone 1130 along at least a portion of the length of the filter 1100. For example, as shown in FIGS. 1-4 , the filter 1100 includes a bending element 1300 configured to allow the filter 1100 to bend or flex along the bending zone 1130 relative to the longitudinal axis. The bending element 1300 allows the filter to navigate and deploy through tortuous tissue structures. In some embodiments, a sealing zone 1140 is also defined on the filter 1100, the sealing zone 1140 being operable to interface with a patient's tissue structure and form a removable seal between the filter 1100 and the tissue structure. The bending zone 1130 and the sealing zone 1140 facilitate optimal interface between the filter 1100 and the tortuous tissue structure. For example, filter 1100 can be deployed within a lumen (e.g., the subclavian artery near the aortic arch) such that the filter 1100 forms an effective seal with the surrounding body tissue structure and is operable to flex or bend in the flex zone 1130 to conform to the profile of the surrounding body tissue structure without stretching or stretching the natural curve or profile of the surrounding body tissue structure.

[0076] In some embodiments, the flex zone 1130 includes at least one flex element 1300 that facilitates bending or flexing of the filter 1100. For example, the flex element 1300 can space or partially mechanically isolate portions of the filter 1100 such that portions of the filter 1100 are partially buffered from one another to reduce the amount of force transmitted to adjacent portions of the filter. In some embodiments, the flex element 1300 extends between adjacent closed cells 1112. The flex element 1300 can extend from the apexes 1113 of the closed cells 1112. For example, the flex element 1300 extends between the second longitudinal apex 1113b of the first closed cell 1112a and the first longitudinal apex 1113a of the second closed cell 1112b. By disposing the flex element 1300 between the first cell 1112a and the second cell 1112b, the first cell and the second cell are partially mechanically isolated and buffered from movement of the other. Additionally, partial mechanical isolation of closed cells 1112 by bending elements 1300 allows filter 1100 to maintain a more consistent diameter during bending. For example, because bending or flexing occurs primarily at bending elements 1300, closed cells (e.g., diamond-shaped closed cells) are not compressed to achieve bending and therefore do not radially expand in response to compression. This allows filter 1100 to maintain a more consistent, desired diameter when deployed.

[0077] In some embodiments, bending elements 1300 are operable to expand and contract, allowing cell rows 1115 to be positioned closer together or farther apart. Furthermore, each bending element 1300 is independent of the other bending elements 1300. This facilitates bending or curving of filter 1100 along its longitudinal length without kinking the body of filter 1100 or creating folds or creases along its longitudinal length. For example, filter 1100 can include multiple bending elements 1300 extending between closed cells 1112 of a first row 1115a and closed cells 1112 of a second row 1115b (as well as a third row 1115c, etc.). One portion of bending element 1300 can be partially or fully extended around an arc length of filter 1100, and another portion of bending element 1300 can be partially or fully compressed around another arc length of filter 1100, allowing the filter to bend or flex along its longitudinal length (as shown in FIG. 4 ). In some embodiments, a fully compressed and / or fully extended bending element 1300 serves as a limit or stop against further bending or curvature of filter 1100 without a substantial increase in bending force. In this manner, bending element 1300 facilitates mechanical isolation of rows 1115 of cells 112, allowing rows 1115 to "flex" independently (e.g., in a corrugated vessel).

[0078] In another embodiment, bending element 1300 is actuatable to articulate 360 ​​degrees about the location where bending element 1300 is coupled to closed cells 1112. For example, in an embodiment in which filter 1100 includes first row 1115a and second row 1115b of closed cells 1112, bending element 1300 can articulate 360 ​​degrees in a plane intersecting filter 1100 at a location along the longitudinal length of filter 1100. This further enables filter 1100 to conform to the shape of a patient's tissue structure, particularly tortuous tissue structures, by providing rows 1115 with the ability to pivot, bend, or otherwise flex to conform to the surface and three-dimensional profile of the patient's tissue structure. Because bending element 1300 can articulate as described above, relatively sharp bends or bends can be achieved along the longitudinal length of filter 1100 to accommodate unique tissue structures, such as the aortic arch.

[0079] In various embodiments, the bending element 1300 includes features to facilitate bending of the filter 1100 and partial mechanical separation of the closed cells 1112. Features to facilitate bending can allow the bending element 1300 to bend, flex, compress, and otherwise articulate. For example, the bending element 1300 includes a serpentine extension that can elastically deform into various shapes, lengths, and angles. The serpentine extension can include a wavy or serpentine path (e.g., an approximately sinusoidal waveform) as shown in FIG. 4. For example, the bending element 1300 can include a connecting portion 1302 and a bending portion 1304. The connecting portion 1302 of the bending element 1300 interfaces with the strut elements 1110 that form the cells 1112, and the bending portion 1304 includes a serpentine extension. The serpentine extension includes a first portion extending generally in a first direction and a second portion that bends approximately 180 degrees and extends in an opposite second direction. In other embodiments, the bending portion 1304 can include a zigzag, coil, or another shape that can be actuated to allow the bending element 1300 to articulate in various directions. In other embodiments, the bending element 1300 can include a variety of other shapes, such as a zigzag (e.g., as shown in FIG. 10C ), a coil or spiral (e.g., as shown in FIG. 10B ), a curve, a U-shape, a C-shape, and any other shape that facilitates adjusting the position of the two vertices 1113 a, 1113 b of adjacent closed cells 1112 a, 1112 b.

[0080] In various embodiments, the particular configuration or characteristics of the bending element 1300 (e.g., the sharpness of the turns, the length of the sections or portions, the size of the slots and the distance therebetween) are selected to provide the bending element 1300 and facilitate articulation of the cells 1113 relative to one another by a specified amount. For example, the particular configuration or characteristics of the bending element 1300 (e.g., the radius of turns of a snake-shaped or spiral bending element 1300) can be configured to allow the capture sections 1108 to articulate such that the relative angle formed between the longitudinal axes (i.e., the angle of articulation) is up to 30 degrees, up to 45 degrees, up to 60 degrees, up to 90 degrees, or up to 180 degrees. The above relative angles are intended to be exemplary and not limiting. For example, the bending element 1300 can be configured to provide an angle of articulation between 90 degrees and 180 degrees. Additionally or alternatively, in some embodiments, the length of the bending element 1300 can be varied to increase or decrease, or the number, shape, and configuration of particular features or features (e.g., number of turns, segment pitch, slot width) that facilitate articulation can be altered, thereby changing the degree of passive articulation. It will be appreciated that while the bending element 1300 can impart greater flexion between cells 1112, the bending element may actually exhibit less flexion than described herein because each of the cells 1112 is joined at various other locations (e.g., lateral vertices 1113c, 1113d) that constrain the travel of the cells 1112 relative to one another.

[0081] In various examples, the bending elements 1300 can be positioned around the capturing section 1108 in various patterns. For example, in some embodiments, the bending elements 1300 can be positioned between each closed cell 1112. In other embodiments, the bending elements 1300 can be positioned periodically between the closed cells 1112, which can increase bending compared to a filter that does not include a bending element, but reduce bending compared to a filter that has a bending element 1300 between each cell 1112. In some embodiments, the bending elements 1300 are positioned on one section of the filter 1100. For example, if the filter 1100 is to be used in connection with the aortic arch, the filter 1100 can include a bending element 1300 positioned on one side of the filter 1100 to promote bending of the capturing section 1108 in a first direction.

[0082] The flexion element 1300 is actuable to allow the two vertices 1113a, 1113b of adjacent closed cells 1112a, which are operably coupled to one another by the flexion element 1300, to articulate relative to one another. In some embodiments, the flexion element 1300 is actuable to allow the vertices 1113a, 1113b to move relative to one another in three directions (e.g., movement relative to one another is not limited to a particular plane). For example, the vertices 1113a, 1113b are actuable to move the vertices longitudinally away from or toward one another via the flexion element 1300 (e.g., the flexion element 1300 is actuable to expand and compress / contract along or parallel to the longitudinal axis). Additionally, the flexion element 1300 is actuable to flex and articulate the closed cells 1112 out of plane with respect to one another (e.g., the planes formed by the closed cells are tilted relative to one another at an angle greater than zero). Similarly, the bending element 1300 is operable to bend and articulate so that the closed cells remain in the same plane, but is operable to bend such that the longitudinal axis formed between the two longitudinal apexes 1113a, 1113b of the first closed cell 1112a and the longitudinal axis formed between the two longitudinal apexes 1113a, 1113b of the second closed cell 1112b are oblique to one another (e.g., at an angle greater than zero). In other words, the bending element 1300 is operable to stretch, collapse, and bend in any direction, i.e., 360 degrees around each of the connection points with the apexes 1113 of the closed cells 1112.

[0083] 11 , bending elements 1300 can be incorporated at other locations in bending zone 1130, such as along strut elements 1110 arranged to form closed cells 1112. In one embodiment, bending elements 1300 can be incorporated into strut elements 1110 along the length of the strut elements. Strut elements 1130 can include a first end 1131 a and a second end 1131 b, with bending elements 1300 positioned between first end 1131 a and second end 1131 b. Thus, bending elements 1300 can be positioned along the edges of closed cells 1112 instead of at the ends or apexes of closed cells 1112. This can increase the flexibility or compliance of filter 1100 by including more locations at which filter 1100 can pivot or bend along its longitudinal length. Increasing the number of bending element 1300 locations along the length of filter 1100 can also increase the storage length for navigating tight turns at the target site. Any number of bending elements 1300 can be implemented along the length of filter 1100 and in various combinations and configurations. For example, a bending element 1300 can be positioned at the apex of each closed cell 1112 in a row 1115 and along the length of each strut element 1110 in each of the closed cells 1112, a bending element 1300 can be positioned at some apexes of the closed cells 1112 and along the length of some of the strut elements 1110 in the closed cells, or a combination thereof. The flexion of filter 1100 is increased by increasing the number of bending elements 1300 disposed on filter 1100.

[0084] When bending elements 1300 are incorporated along the length of strut elements 1110, bending elements 1300 can be generally circumferentially aligned with one another longitudinally along filter 1100 to form bending element rows 1306. Bending elements 1300 within bending element rows 1306 can be slightly staggered to facilitate compressing filter 1100 into a delivery configuration. However, even when bending elements 1300 are slightly staggered, bending elements 1300 are positioned within circumferential zones that facilitate bending of filter 1100. Looking to FIG. 12 , by incorporating bending elements 1300 along the length of strut elements 1110 in addition to incorporating bending elements 1300 at the apexes 1113 of cells 1112, filter 1100 can be deployed at shorter lengths. Having additional bending element 1300 increases the flexibility of filter 1100, allowing for a shorter transition in the longitudinal length of filter 1100 when partially deployed such that one longitudinal end remains constrained and the other longitudinal end is deployed. Because the transition region is shorter, filter 1100 is operable to be deployed within a vessel such that a seal is created with surrounding tissue (e.g., a vessel wall) while a portion of filter 1100 is still in a constrained configuration. This allows filter 1100 to be deployed and actuated in locations where the vessel profile restricts or limits the deployment of filter 1100 along its entire length. Furthermore, the operational length of filter 1300 is increased in that the range of deployment is increased. Specifically, in embodiments that do not include bending elements, filter 1100 may need to be unconstrained for at least 2-3 cm or more in order for filter 1100 to expand to a diameter sufficient to contact and form a seal with surrounding tissue. However, embodiments that include bending elements 1300 significantly reduce the length of filter 1100 that is unconstrained to create a seal with tissue compared to embodiments that do not include bending elements 1300.For example, embodiments employing bending element 1300 are operable to facilitate deployment of filter 1100 such that when a first length of filter 1100 (first length approximately equal to 1.5 cells 1112) is unconstrained, filter 1100 is operable to expand to an expanded state over at least a portion of its longitudinal length. It should be appreciated that this ratio will vary somewhat with the diameter of filter 1100 as it increases or decreases relative to that illustrated herein.

[0085] In some embodiments, bending element 1300 is formed of a shape memory material. The shape memory properties of bending element 1300 facilitate bending element 1300 returning to a preset shape or configuration. Bending element 1300 is operable to elastically deform and return to a neutral configuration. For example, bending element 1300 is configured to elastically deform under normal operating conditions (e.g., where bending element 1300 is configured to elastically deform to accommodate the maximum expected articulation movement during a given intravascular procedure). By configuring bending element 1300 to elastically deform under expected operating conditions (e.g., an expected angle of articulation), the embolic filter system allows filter 1100 to articulate in an elastic manner such that bending element 1300 elastically returns to its preset shape when the force required to cause the articulation is removed. Such a configuration allows embolic filter system 1000 to linearly align for collapse and removal after an intravascular procedure. In some embodiments, the flexure element 1300 is non-rigid to allow relative articulation of the structural elements that form the capture section 1108 from which the flexure element 1300 extends.

[0086] In embodiments in which the bending element 1300 is formed of a shape-memory material, the force required to deform the bending element 1300 can be less than the force required to deform the structural elements forming the capture section 1108, allowing the structural elements to resist forces that subsequently deform the bending element 1300 and return to the shape-set configuration. For example, when the filter 1100 is deployed in situ, the structural elements forming the capture section 1108 can expand from a constrained configuration within the delivery device toward an expanded configuration. The bending element 1300 can elastically deform or flex as portions of the structural elements forming the capture section 1108 self-expand while other portions remain in the constrained configuration. Because the bending element 1300 is actuatable to extend, contract, and articulate, the capturing section 1108 is operable to expand further toward the delivery configuration with reduced resistance to expansion compared to embodiments in which the structural elements of the capturing section 1108 forming the first closed cell 1112a are directly coupled to the structural elements forming the second closed cell 1112b. In other words, the rows 1115 of closed cells 1112 are operable to expand to the deployed configuration or to make secure contact with the target tissue more quickly (with less expansion of filter 1100 as a whole) than if the rows 1115 of closed cells 1112 were directly joined together at their vertices 1113. This can be described as filter 1100 "flowering" as it expands toward the deployed configuration.

[0087] Because bending element 1300 is operable to allow filter 1100 to bend or flex along its longitudinal length, filter 1100 is operable to deploy orthogonally in a target lumen. For example, when a lumen includes a substantially circular cross-section when viewed perpendicular to its longitudinal axis, filter 1100 is operable to deploy such that the cross-section of filter 1100 is similarly circular when viewed perpendicular to the filter's longitudinal axis. In other words, when deployed, filter 1100 conforms to the shape of the lumen so that their respective longitudinal axes are similarly positioned (e.g., the lumen and filter 1100 are coaxial). This is particularly important at first end 1102 of filter 1100 so that a functional seal is formed and all of the fluid flowing through the lumen flows through filter 1100. This is further important in body tissue structures that are tortuous or at the intersection of various lumens (e.g., near an ostium, such as in the aortic arch).

[0088] In some embodiments, the structural elements of the capture section 1108 from which the bending elements 1300 extend may not form completely closed cells. For example, the structural elements can form partial cells when positioned at the first end 1102 of the filter 1100. The bending elements 1300 are not limited to being positioned between closed cells 1112, but can extend between partial cells or between closed cells 1112 and partial cells. Furthermore, the bending elements 1300 are not limited to extending from the longitudinal apexes 1113 a, 1113 b of the cells, but can also extend from lateral apexes 1113 c, 1113 d formed by the structural elements of the capture section 1108. Thus, the bending elements 1300 can connect cells within a row 1115 as well as between different rows 1115.

[0089] As described above, filter 1100 can include one or more shape memory alloys and, therefore, can include one or more expandable segments. Accordingly, in various embodiments, filter 1100 is configured to transition between a delivery configuration and a deployed configuration, such that in the deployed configuration, one portion of filter 1100 expands relative to other portions of filter 1100. For example, in the delivery configuration, each of the various segments of filter 1100 has a profile (e.g., diameter) suitable 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 segments of filter 1100 expand relative to one or more of the other various segments of filter 1100. As shown in FIG. 1 , embolic filter system 1000 is shown in the deployed configuration, with the structural elements of capture segment 1108 expanding relative to each of articulating segment 1118, mounting segment 1114, and elongated segment 1200. In some embodiments, filter 1100 is configured such that the components of capture section 1108 are self-expandable, although in other embodiments, filter 1100 is configured such that the structural elements of capture section 1108 are expandable through the use of an expansion aid (such as a balloon).

[0090] In various embodiments, elongate element 1200 is a longitudinally extending structure having first end 1202 and second end 1204. In some embodiments, elongate element 1200 is configured to receive blood and / or embolic debris directed by filter 1100 into embolic filter system 1000. Accordingly, in some embodiments, elongate element 1200 includes a lumen. In various embodiments, elongate element 1200 is configured to be advanceable through a vessel. Thus, elongate element 1200 is generally flexible yet longitudinally stable and compressible without risk of lumps or kinks under loading conditions similar to advancement through a vessel, including advancement through one or more delivery catheters. In some embodiments, elongate element 1200 can include braided, wound, or cut reinforcing members attached to a body portion of elongate element 1200 as a framework that adds stability to the structure of elongate element 1200. The reinforcing member can be formed into a braid by braiding multiple wire strands made of a suitable material. In any case, the reinforcing member (e.g., the wires or filaments forming the reinforcing member) can be made of metals and alloys (e.g., Nitinol), polymeric materials, elastomeric materials, natural materials, or any combination thereof. The reinforcing member can be braided symmetrically (e.g., with opposing biases in an up-and-down configuration to form a typical braid) or asymmetrically, with each strand of braided wire oriented at a pitch angle of 0°-10°, 10°-20°, 20°-30°, 30°-40°, 40°-50°, 50°-60°, 60°-70°, 70°-80°, 80°-90°, or any combination thereof, relative to the longitudinal axis of the braided wire.

[0091] The elongated element 1200 can therefore comprise a variety of materials, including, but not limited to, medical-grade polymeric materials, including thermoplastic polymers, organic silicone polymers, or polyamides. Polyether block amides (e.g., PEBAX®), nylon, polytetrafluoroethylene (PTFE), and stainless steel are non-limiting suitable examples. The elongated element 1200 can be formed by known methods, such as extrusion. In some embodiments, the elongated element 1200 can include one or more reinforcing elements, such as one or more fibers or braids, extending along or within the material of the elongated element 1200. For example, in some embodiments, the elongated element 1200 can comprise coil-reinforced nylon or PEBAX®.

[0092] In some embodiments, the elongate element 1200 can be formed using a high hardness material, where the hardness of the elongate element 1200 can be 50-60 Shore units, 60-70 Shore units, 70-80 Shore units, 80-90 Shore units, or a combination thereof. Such materials can include thermoplastics, such as 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 general-purpose plastics, including 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 PPO), and the like. PPE), thermoplastic polyurethane (TPU); polyamides such as nylon 11 and nylon 12, polyoxymethylene (POM or acetal), polyethylene terephthalate (PET, a thermoplastic polyester), polybutylene terephthalate (PBT, a thermoplastic polyester), polyimide (PI, an imidized plastic), polyamideimide (PAI, an imidized plastic), polybenzimidazole (PBI, an imidized plastic), polysulfone (PSU), polyetherimide (PEI), polyethersulfone (PES), polyarylsulfone (PAS); polyphenylene sulfide (PPS), polyetheretherketone (PEEK); fluoropolymers including 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 materials include elastomeric organosilicone polymers and polyether block amides.In particular, polyamides can include nylon 12, nylon 11, nylon 9, nylon 6 / 9, and nylon 6 / 6. In certain embodiments, PET, nylon, and PE can be selected for medical balloons used in high-pressure applications. In some embodiments, elongate element 1200 can include a braid reinforcement structure to improve burst pressure resistance. In some embodiments, elongate element 1200 can include one or more layers of a hydrophilic coating or other type of low-friction coating and / or liner to reduce surface friction. The selection of specific materials depends on the desired properties or intended use of the balloon.

[0093] The reinforcing members described above can be combined with a high hardness material to form elongate element 1200 such that the body portion of elongate element 1200 is strengthened when the end of elongate element 1200 is inserted into second end 1104 of filter 1100. In some embodiments, the high hardness material facilitates bonding of the end of elongate element 1200 to second end 1104 (e.g., by facilitating greater flow rate and mechanical engagement during heating and / or by increasing frictional / stictional engagement). In some embodiments, an adhesive, such as a UV-curable adhesive, can be used to aid in bonding, as described above.

[0094] In some embodiments, blood and / or embolic debris entering the elongate element 1200 flows through the lumen of the elongate element 1200, such as from the second end 1204 of the elongate element 1200 to the first end 1202 of the elongate element 1200. In some embodiments, one or more auxiliary systems 2000 can be fluidly coupled to the lumen of the elongate element 1200, such as at the first end 1202 of the elongate element 1200. In some such embodiments, such auxiliary systems 2000 can be actuable to aspirate the contents (e.g., embolic debris and / or blood) of the lumen of the elongate element 1200.

[0095] In some embodiments, the lumen of elongate element 1200 forms a working lumen through which one or more medical devices (e.g., guidewire, endoprosthesis) can be advanced to a treatment area proximate embolic filter system 1000. In various embodiments, the lumen of elongate element 1200 acts as both a working lumen for medical device delivery and a structure for redirecting embolic debris and / or blood flow. In some embodiments, the working lumen of elongate element 1200 can range from 4 Fr to 26 Fr or greater.

[0096] Examples of medical devices that may be passed through the lumen of the elongate element 1200 include, but are not limited to, catheters, thrombectomy devices, atherectomy devices, embolectomy devices and associated tools, contrast agents, drug delivery agents, intravascular prostheses including stents, stent grafts and valves, and the like.

[0097] In various embodiments, embolic filter system 1000 includes a membrane disposed along one or more portions of filter 1100 and, optionally, along one or more portions of elongate element 1200. For example, as shown in FIG. 3 , membrane 1400 is disposed around the exterior surfaces of capture segment 1108 and articulating segment 1118 of filter 1100. In such an embodiment, by disposing membrane 1400 along capture segment 1108, membrane 1400 acts to filter and retain embolic debris within embolic filter system 1000 that would otherwise pass freely through voids (e.g., closed cells 1112) in capture segment 1108 and articulating segment 1118 and be freely discharged.

[0098] Under certain conditions, the force required to retract embolic filter system 1000 from the vessel can be quite high (e.g., greater than the force required to bend articulating section 1118 to facilitate articulating movement between filter 1100 and elongate element 1200). For example, removal of embolic filter system 1000 can involve retracting embolic filter system 1000 within the delivery catheter, which can involve re-collapse of deployed filter 1100, and the distal end of the delivery catheter can act as a support surface to radially collapse filter 1100 as embolic filter system 1000 is retracted into the lumen of the delivery catheter.

[0099] The membrane 1400 can additionally or alternatively be disposed around the inner surfaces of the capture section 1108 and the articulating section 1118. In some embodiments, the membrane 1400 can optionally extend to cover a portion of the overlapping section of the elongate element 1200 and the attachment section 1114 of the filter 1100.

[0100] In some embodiments, membrane 1400 acts to filter or otherwise condition blood and embolic debris flowing through embolic filter system 1000. In some embodiments, membrane 1400 is permeable to certain blood media (blood-permeable) and impermeable to other blood media and / or embolic debris. Specifically, in some embodiments, membrane 1400 is configured to allow certain blood media (e.g., red blood cells, white blood cells, plasma, platelets) flowing through embolic filter system 1000 to pass through membrane 1400 of filter 1100 and re-enter the vessel, while membrane 1400 is impermeable to other certain blood media and embolic debris. In some embodiments, membrane 1400 is impermeable to embolic debris of a specified size or larger. That is, in some embodiments, membrane 1400 acts to prevent embolic debris of a specified size or larger from passing through membrane 1400 of filter 1100 and re-entering the vessel.

[0101] In some embodiments, blood media and embolic debris that flow into embolic filter system 1000 and do not permeate back into the vessel are captured and retained within filter 1100, or are further directed into elongate element 1200. In some embodiments, as described in more detail below, filter 1100 is collapsible so that the blood media and embolic debris captured within filter 1100 can then be removed along with detaching embolic filter system 1000 from the vessel.

[0102] In some embodiments, blood and / or embolic debris directed into elongate element 1200 can be aspirated from embolic filter system 1000 prior to removal from the vessel. Removing embolic debris trapped within filter 1100 helps minimize the risk of unintentional release of trapped debris into the patient's vasculature when embolic filter system 1000 is removed from the patient's vasculature. For example, a known risk during embolic debris filtering procedures is the risk of membrane 1400 of filter 1100 tearing during removal. An embolic filter filled with embolic debris generally occupies a larger cross-sectional area than an embolic filter free of embolic debris. This increased cross-sectional area can be associated with difficulty in sufficiently collapsing the embolic filter to a configuration that allows it to be fully retracted into the delivery catheter. Even if the filter cannot be retracted into the delivery catheter, it can be difficult to pull a filter with an increased diameter as a result of being filled with embolic debris back through tortuous vessels.

[0103] The membrane 1400 can comprise a variety of materials, including, but not limited to, polymers such as expanded polytetrafluoroethylene (expanded PTFE), expanded modified PTFE, expanded copolymers of PTFE, fluoropolymers such as FEP, PFA, nylon, polyurethane, polycarbonate, polyethylene, polyester, silicone and silicone elastomers (e.g., SYLGARD™ 184), urethane, thermoplastic polyurethane, polypropylene, and the like.

[0104] In various embodiments, one or more regions of such materials can also or instead be modified by forming one or more perforations therein to control the permeability of the material. For example, a material such as expanded fluoropolymer (or other suitable polymer) can be further modified by perforating one or more regions of the material to achieve a specified porosity. Examples include laser cutting or laser drilling holes or perforations into the material. Other materials with woven, knitted, or lattice structures may also serve as suitable materials depending on their permeability / porosity. Furthermore, a desired permeability can be achieved by adding or removing layers of membrane material, as will be appreciated by those skilled in the art. Additionally or alternatively, the permeability of membrane 1400 can be optimized by manipulating the microstructure of the membrane material. In such an example, the node and fibril structure of the expanded fluoropolymer can be modified / optimized to achieve a desired permeability. For example, the expanded fluoropolymer can be processed so that the node and fibril structure of the expanded fluoropolymer is generally impermeable to embolic particles (and other blood media) of a specified size, as discussed below.

[0105] In some embodiments, the membrane material can be configured such that one or more portions or regions are permeable to media up to a specified size, while one or more other portions or regions are impermeable to media of the specified size or larger. In some embodiments, the pores or perforations (or voids in a node-and-fibril microstructure) present in the membrane material can vary, for example, from the proximal end to the distal end and / or at one or more discrete locations.

[0106] In various embodiments, membrane 1400 can be configured such that membrane 1400 is impermeable to embolic debris of about 140 μm or greater. In some such embodiments, the average pore size (or perforation size, or void size in the node-and-fibril microstructure of membrane 1400) can be less than 140 μm. In other embodiments, membrane 1400 can be configured such that membrane 1400 is impermeable to embolic debris smaller than 140 μm, such as embolic debris in the range of 40 μm to 99 μm. Such embodiments are not intended to be limiting. For example, if desired, membrane 1400 can be configured to be permeable to embolic debris of 100 μm, 120 μm, 140 μm, 160 μm, 180 μm, 200 μm (or larger), or any size therebetween, in which case the average pore size (or perforation size, or void size in the node-and-fibril microstructure of membrane 1400) can be greater than 150 μm.

[0107] In various embodiments, embolic filter system 1000 is advanced to a treatment area within a vessel in a delivery configuration, after which embolic filter system 1000 is deployed or otherwise operable to transition to the deployed configuration. In the delivery configuration, embolic filter system 1000 is in a generally contracted configuration. In some embodiments, in the delivery configuration, capture section 1108 is radially contracted (e.g., with a low delivery profile) such that capture section 1108 is operable to be delivered within a vessel, such as through a delivery catheter, as discussed further below. In some embodiments, one or more of articulation section 1118, attachment section 1114, and one or more regions of elongate element 1200 can, but need not, additionally be radially contractible. In the deployed configuration, capture section 1108 transitions to a radially expanded configuration ( FIG. 1 ) operable to obstruct blood flow and filter embolic debris therefrom. In some embodiments, one or more of the articulating section 1118, the attachment section 1114, and one or more regions of the elongated section 1200 may, but need not, additionally be radially expandable in the delivery configuration.

[0108] After the intravascular procedure is completed, embolic filter system 1000 is operable for removal from the vessel. In some embodiments, embolic debris captured by embolic filter system 1000 can be aspirated or otherwise removed from embolic filter system 1000 prior to removal of embolic filter system 1000 from the vessel, as described herein. In some embodiments, to remove embolic filter system 1000, embolic filter system 1000 transitions from a deployed configuration to a delivery configuration. In some embodiments, this transition from the deployed configuration to the delivery configuration includes contraction of one or more portions of embolic filter system 1000 (e.g., filter 1100 and one or more portions of elongated section 1200). For example, in various embodiments, removal of embolic filter system 1000 includes radially contracting or compressing capture section 1108 of filter 1100 to a profile (e.g., diameter) conducive to intravascular detachment. It should be appreciated that the diameter of the structural elements of capture section 1108 is smaller when embolic filter system 1000 is in the delivery configuration than when embolic filter system 1000 is in the deployed configuration.

[0109] Embolic filter system 1000 is operable for delivery to a treatment area within a vessel in connection with a variety of delivery methods. Accordingly, embolic filter system 1000 is also operable for assembly in a variety of ways. Described in detail below are various assembly and delivery methods associated with embolic filter system 1000.

[0110] Next, FIG. 5 is a flowchart outlining one example method of assembling a medical device including embolic filter system 1000. As shown, in step 5000, embolic filter system 1000 is provided. As described above, embolic filter assembly generally includes filter 1100 coupled to elongate element 1200, with membrane 1400 extending along one or more portions of filter 1100 and, optionally, along one or more portions of elongate element 1200. In step 5002, a delivery catheter is provided. In various embodiments, the delivery catheter can be a COTS delivery catheter, as described above. In various embodiments, the delivery catheter includes an elongate element having a distal end, a proximal end, and a lumen extending from the proximal end to the distal end. A COTS delivery catheter 6000 is shown in FIG. 6A along with embolic filter system 1000 including filter 1100, elongate element 1200, and membrane 1400. COTS delivery catheter 6000 can optionally include one or more connectors, such as connector 6100, which can include hemostatic valves or other elements. It should be appreciated that embolic filter system 1000 is shown in FIG. 6A.

[0111] 5, in step 5004, the proximal end of embolic filter system 1000 is inserted into the lumen of the delivery catheter and advanced proximally through the lumen of the delivery catheter until the proximal end of embolic filter system 1000 extends proximally of the proximal end of the delivery catheter. For example, as shown in FIG. 6B, the second end 1004 of embolic filter system 1000 is inserted into the lumen of delivery catheter 6000 at the distal end 6002 of delivery catheter 6000 and advanced proximally through the lumen of delivery catheter 6000 until the second end 1004 of embolic filter system 1000 extends proximally of the proximal end 6004 of delivery catheter 6000.

[0112] 5, in step 5006, embolic filter system 1000 is retracted proximally until filter 1100 is received within the lumen of delivery catheter 6000. Figures 6C and 6D illustrate the proximal retraction of embolic filter system 1000 relative to delivery catheter 6000, with in Figure 6C embolic filter system 1000 being retracted so that filter 1100 is partially received within the lumen of delivery catheter 6000, and in Figure 6D embolic filter system 1000 being retracted so that filter 1100 is fully received within the lumen of delivery catheter 6000.

[0113] With filter 1100 fully received within the lumen of delivery catheter 6000, as shown in Figure 6D, delivery catheter 6000 can be inserted into the patient's vasculature and advanced to a treatment site within the vasculature, after which embolic filter system 1000 can be advanced relative to delivery catheter 6000 (e.g., by one or more of advancing embolic filter system 1000 distally relative to delivery catheter 6000 and retracting delivery catheter 6000 proximally relative to embolic filter system 1000) such that filter 1100 extends distally from a distal end 6002 of delivery catheter 6000. In some embodiments, as described above, one or more portions of filter 1100, such as capture section 1108, are configured to radially expand to obstruct blood flow and filter embolic debris therefrom.

[0114] For example, as shown in Figures 6E and 6F, embolic filter system 1000 is advanced distally relative to delivery catheter 6000 such that filter 1100 extends from the distal end 6002 of delivery catheter 6000. Figure 5E shows a portion of filter 1100 extending from the distal end 6002 of delivery catheter 6000 and partially deployed (e.g., radially expanded), while Figure 6F shows filter 1100 extending from the distal end 6002 of delivery catheter 6000 and fully deployed (radially expanded). It will be appreciated that Figures 6E and 6F show embolic filter system 1000 and delivery catheter 6000 outside the body for clarity.

[0115] FIG. 7 is a flowchart outlining another example method of assembling a medical device including embolic filter system 1000. As shown, in step 7000, embolic filter system 1000 is provided, similar to the method discussed above with respect to step 5000 of FIG. 5. Step 7002 involves providing a delivery catheter, similar to the method discussed above with respect to step 5002 of FIG. 5. In step 7004, a constraining sheath is provided, such as a COTS constraining sheath or one specifically designated for use in combination with embolic filter system 1000. The constraining sheath can optionally be splittable or otherwise configured to be peeled away from embolic filter system 1000 and the delivery system. FIG. 8A is a diagram of delivery catheter 6000 with connector 6100 along with embolic filter system 1000 and constraining sheath 8000.

[0116] 7 , in step 7006, the proximal end of embolic filter system 1000 is inserted into the lumen of the constraining sheath and advanced proximally through the lumen of constraining sheath 8000 until the proximal end of embolic filter system 1000 extends proximal to the proximal end of the constraining sheath. For example, as shown in FIG. 8B , second end 1004 of embolic filter system 1000 is inserted into the lumen of constraining sheath 8000 at distal end 8002 of constraining sheath 8000 and advanced proximally through the lumen of constraining sheath 8000 until second end 1004 of embolic filter system 1000 extends proximal to proximal end 8004 of constraining sheath 8000.

[0117] 7, in step 7008, embolic filter system 1000 is retracted proximally until filter 1100 is received within the lumen of constraining sheath 8000. Figures 8C-8F illustrate the proximal retraction of embolic filter system 1000 relative to constraining sheath 8000. In Figures 8C-8E, embolic filter system 1000 is retracted so that filter 1100 is partially received within the lumen of constraining sheath 8000, and in Figure 8F, embolic filter system 1000 is retracted so that filter 1100 is fully received within the lumen of the constraining sheath. In various embodiments, as further described below, retraction of embolic filter system 1000 relative to constraining sheath 8000 can optionally be performed with delivery catheter 6000 inserted within the vessel. In some embodiments, retraction of the embolic filter system 1000 relative to the constraining sheath 8000 can optionally be accomplished using a guidewire extending through one or more of the delivery catheter 6000, the embolic filter system 1000, and the constraining sheath 8000, as shown in Figures 8C-8F.

[0118] Additionally, in some embodiments, elongate element 1200 can have one or more visible markers at its proximal end (e.g., the end of elongate element 1200 being manipulated by the operator in FIG. 8D ) and one or more visible markers at its distal end (e.g., the end proximal to filter 1100) so that an operator can see how far into the patient's body filter 1100 coupled to the distal end of elongate element 1200 is currently positioned by observing the location of each of the markers. In some embodiments, the proximal marker is visible to the naked eye, and the distal marker is visible under a fluoroscopic microscope (e.g., radiopaque). In some embodiments, one or both of the proximal and distal ends include only one visible marker. In some embodiments, the visible markers are spaced along a portion of the length of elongate element 1200 at regular or variable increments (e.g., 1 mm, 0.5 cm, 1 cm, 2 cm, or other suitable increments deemed useful by the operator). Similarly, visible markers can be located at both ends of elongate element 1200 or along the length of filter 1100 and / or articulating section 1118. As mentioned above, in some embodiments, the visible marker located at the distal end is a radiopaque marker made from a material such as high-visibility tantalum or other metal or alloy that is visible in fluoroscopic images. By using markers located at either or both the proximal and distal ends, the operator can better understand the relative position of filter 1100 within the patient's body.

[0119] 7, in step 7010, 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, with reference to Figures 8G and 8H, the distal end 8002 of the constraining sheath 8000 is inserted into the lumen of the delivery catheter 6000 at the proximal end 6004 of the delivery catheter 6000, while leaving the filter 1100 of the embolic filter system 1000 constrained within the lumen of the constraining sheath 8000. In some embodiments, this involves inserting the distal end 8002 of the constraining sheath 8000 into a connector of the delivery catheter 6000, such as connector 6100. Figure 8G shows the restraining sheath 8000 and the filter 1100 of the embolic filter system 1000 restrained therein advancing toward the proximal end 6004 of the delivery catheter 6000, and Figure 8H shows the distal end 8002 of the restraining sheath 8000 inserted into the lumen of the delivery catheter 6000 at the proximal end 6004 of the delivery catheter 6000.

[0120] 7 , in step 7012, with the distal end of the constraining sheath inserted into the lumen of the delivery catheter at the proximal end of the delivery catheter, embolic filter system 1000 is advanced distally relative to the constraining sheath and delivery catheter until filter 1100 is received within the lumen of the delivery catheter. For example, as shown in FIG. 81 , with the distal end 8002 of constraining sheath 8000 inserted into the lumen of delivery catheter 6000 at the proximal end 6004 of the delivery catheter, embolic filter system 1000 is advanced distally in the direction of arrow A relative to constraining sheath 8000 and delivery catheter 6000 until filter 1100 is received within the lumen of delivery catheter 6000. FIG. 8J partially illustrates embolic filter system 1000 inserted into the lumen of delivery catheter 6000 such that filter 1100 is received within and constrained by delivery catheter 6000 in the delivery configuration (e.g., radially constrained).

[0121] 7 , after filter 1100 of embolic filter system 1000 is received within the lumen of the delivery catheter, the constraining sheath is removed according to step 7014. In various embodiments, constraining sheath 8000 is removed from the lumen of delivery catheter 6000 during detachment. In some embodiments, constraining sheath 8000 is advanced proximally along and relative to elongate element 1200 of embolic filter system 1000 until distal end 8002 of the constraining sheath is translated away from or distal to proximal end 1004 of embolic filter system 1000. However, in some embodiments, as described above, constraining sheath 8000 is splittable or otherwise configured to be peeled away from embolic filter system 1000 and delivery catheter 6000. Such a splittable constraining sheath facilitates removal when one or more connectors (e.g., Tuohy-Borst connectors) are coupled to elongate elements 1200 of embolic filter system 1000 proximal to constraining sheath 8000. In some such embodiments, the splittable constraining sheath can be removed from embolic filter system 1000 and delivery catheter 6000 without having to remove connectors coupled to elongate elements 1200 of embolic filter system 1000 proximal to constraining sheath 8000.

[0122] An example of removal of such a splittable constraining sheath 8000 is shown in Figures 8J and 8K, in which the constraining sheath 8000 is split into two sections for removal from the embolic filter system 1000 and delivery catheter 6000. Figure 8L shows the embolic filter system 1000 with the filter 1100 completely received within the lumen of the delivery catheter 6000.

[0123] Once filter 1100 is fully received within the lumen of delivery catheter 6000, as shown in FIGURE 8L, delivery catheter 6000 can be inserted into the patient's vasculature and advanced to a treatment site therein, after which embolic filter system 1000 can be advanced relative to delivery catheter 6000 (e.g., by one or more of: advancing embolic filter system 1000 distally relative to delivery catheter 6000; retracting delivery catheter 6000 proximally relative to embolic filter system 1000) such that filter 1100 extends distally from the distal end 6002 of delivery catheter 6000. As discussed above, one or more portions of filter 1100, such as structural elements of capture section 1108, are configured to radially expand to obstruct blood flow and filter embolic debris therefrom.

[0124] 9 is a flowchart outlining an example method for delivering a medical device, including embolic filter system 1000, to a region within a patient's vasculature. As shown, steps 9000-9008 are the same as steps 7000-7008 described above in connection with FIG. 7. In step 9010, a delivery catheter is inserted into the patient's vasculature and advanced until the distal end of the delivery catheter is located in a treatment area of ​​the vasculature. Thus, while the above discussion involves advancing the delivery catheter to a treatment area within the patient's vasculature after embolic filter system 1000 is received within delivery catheter 6000, in some embodiments, delivery catheter 6000 can instead be inserted into the patient's vasculature and advanced until the distal end of the delivery catheter is located in a treatment area of ​​the vasculature prior to inserting embolic filter system 1000 into delivery catheter 6000.

[0125] In step 9012, 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 generally identical to step 7010 of FIG. 7, except that step 9012 is performed with the delivery catheter in situ (i.e., while the delivery catheter remains inserted within the patient's vasculature). Accordingly, reference is made to FIGS. 8G and 8H, which illustrate the distal end 8002 of the constraining sheath 8000 being inserted into the lumen of the delivery catheter 6000 at the proximal end 6004 of the delivery catheter 6000. Those skilled in the art will appreciate that the inventive concepts of the present disclosure enable the step of inserting the constraining sheath into the lumen of the delivery catheter to be performed in situ, or alternatively, at the proximal end of the delivery catheter prior to advancing the delivery catheter to the treatment area within the vasculature.

[0126] Such a multifaceted system allows the embolic filter system 1000 to be delivered to remote regions of the vessel that may be inaccessible with conventional systems. Such a system also allows the embolic filter system 1000 to be delivered to remote regions of the vessel while minimizing trauma to the vessel. For example, those skilled in the art will appreciate that additional components increase the stiffness of the delivery catheter when received within the lumen of the delivery catheter. A relatively stiff delivery catheter may not be operable to navigate tortuous body tissue structures to reach certain regions of the vessel and / or may injure the vessel as a result of its inflexibility. The embolic filter system 1000 described herein allows a relatively flexible delivery catheter to be initially advanced to a treatment area within the vessel (e.g., through or within a relatively tortuous region) without placing one or more additional components within the delivery catheter that act to increase the stiffness of the delivery catheter. Furthermore, such a configuration allows the delivery catheter to act as a protective boundary and support surface separating the embolic filter system 1000 from the surrounding vessels as the embolic filter system 1000 is advanced to the treatment area.

[0127] Steps 9014 and 9016 are the same as steps 7012 and 7014 described above in connection with Figure 7. Similarly, as illustrated and described above, it should be appreciated that after filter 1100 of embolic filter system 1000 has been advanced through the lumen of a delivery catheter to the treatment site, embolic filter system 1000 is operable to be deployed from the distal end of the delivery catheter (e.g., by one or more of advancing embolic filter system 1000 distally relative to the delivery catheter and retracting the delivery catheter proximally relative to embolic filter system 1000) such that filter 1100 extends distally from the distal end of the delivery catheter and expands to obstruct blood flow and filter embolic debris therefrom.

[0128] The multi-angled nature of embolic filter system 1000 described herein also facilitates retraction of embolic filter system 1000 from a vessel and its in situ repositioning. For example, during or after deployment of embolic filter system 1000 within a vessel, an operator can manipulate the angular relationship between filter 1100 and elongate element 1200 of embolic filter system 1000 to better align filter 1100 with the vessel in which the system is deployed. For example, as described above, embolic filter system 1000 is operable to create relative articulating movement between filter 1100 and elongate element 1200 by articulating section 1118 bending or flexing in response to advancement and retraction of elongate element 1200. When filter 1100 is deployed within a vessel, one or more portions of filter 1100 engage the vessel wall, thereby creating engagement between filter 1100 and the vessel.

[0129] With filter 1100 engaged with the vessel, elongate element 1200 is operable to be advanced or retracted. Under certain conditions, advancement of elongate element 1200 with filter 1100 at least partially engaged with the vessel wall places embolic filter system 1000 in a compressive loading condition. In certain instances, such as when filter 1100 is improperly aligned with the vessel in which it is deployed, such a compressive loading condition can cause articulating section 1118 of embolic filter system 1000 to bend, thereby causing relative articulating movement between filter 1100 (or at least its distal end) and elongate element 1200, as described above. Conversely, under certain conditions, retraction of elongate element 1200 with filter 1100 at least partially engaged with the vessel wall places embolic filter system 1000 in a tensile loading condition. In certain instances, such as when filter 1100 is misaligned with elongate element 1200, this tensile loading condition straightens articulating section 1118 of embolic filter system 1000, thereby creating a relative articulating motion between filter 1100 (or at least its distal end) and elongate element 1200, moving filter 1100 and elongate element 1200 toward alignment with one another. Thus, elongate element 1200 can be advanced and retracted to create an articulating motion between filter 1100 (or at least its distal end) and elongate element 1200, which can be utilized to properly align filter 1100 within the vessel. It should be appreciated that proper alignment of filter 1100 within the vessel does not require alignment between filter 1100 and elongate element 1200, but may require misalignment between filter 1100 and elongate element 1200.

[0130] While embolic filter system 1000 of the various embodiments and figures described above incorporates filter 1100 having articulating section 1118 therein, in some other embodiments, embolic filter system 1000 can additionally or alternatively include one or more independent articulating elements positioned proximal to filter 1100 and enabling articulating movement between filter 1100 and one or more portions of elongate element 1200. That is, in some embodiments, embolic filter system 1000 includes an articulating element that is independent of (e.g., not part of) filter 1100. For example, filter 1100 can include the structural elements of capture section 1108 without including articulating section 1118.

[0131] The articulation element in such embodiments may be functionally similar to the articulation section 1118 of filter 1100 described above, except that the articulation section is not an integral part of filter 1100, but is an independent component that is coupled (indirectly or directly) to one or more of filter 1100 and elongate element 1200. Thus, in some embodiments, the articulation element comprises a helically cut or slotted tubular construction. As noted above, in examples involving cut tubing, the cut in the tubing to form the coil / helical or slotted section extends through the thickness of the tubing (e.g., from the outer surface of the tubing to the inner surface of the tubing) so that the inner lumen of the tubing is exposed. Such a cut through the entire thickness of the tubing provides a gap that can accommodate bending (e.g., one or more helical bends) in one or more relevant portions of the tubing.

[0132] 10A-10C illustrate a preferred bending element 1300. As disclosed above, the bending element 1300 can include a variety of configurations, including a snake-like shape (e.g., FIG. 10A), a coil-like shape ( FIG. 10B), and a zigzag shape ( FIG. 10C). Additionally, in various embodiments, the bending element 1300 can be formed continuously with the capture section 1108 (e.g., multiple strut elements 1110), in which case the bending element 1300 is thinner, narrower, or has a smaller profile than other portions of the capture section 1108 to facilitate increased flexibility of the bending element 1300.

[0133] In some embodiments, elongate element 1200 is configured so that its length can be easily modified in connection with an intravascular procedure. For example, in some embodiments, elongate element 1200 can be cut so that the length of elongate element 1200 can be modified from a first length to a second, shorter length. In some embodiments, elongate element 1200 is configured so that the length of elongate element 1200 can be modified when embolic filter system 1000 is received within the lumen of delivery catheter 6000. In some embodiments, an attachable / detachable hub is coupled to the proximal end of elongate element 1200 to fluidly seal the lumen of delivery catheter 6000. For example, the hub can optionally have a luer taper connection, a hose barb connection, or a combination thereof (e.g., a luer-barb attachment connection) to be used to form a leak-tight connection at the proximal end of elongate element 1200. In some embodiments, the hub may be permanently attached or coupled to the proximal end of the elongate element 1200, while in other embodiments, the hub may be removably attached thereto.

[0134] In some embodiments, elongate element 1200 includes multiple preset segments configured to be removed. For example, in some embodiments, elongate element 1200 includes a first removable segment and a second removable segment, and either or both of the first and second removable segments can be removed to modify the length of the elongate element from a first length to a second, shorter length. In some embodiments, the removable segments can be configured to be removed by cutting. In other embodiments, the removable segments can additionally or alternatively be configured to be removed by twisting, bending, or pulling the removable segments relative to other portions of elongate element 1200.

[0135] In some embodiments, one or more portions or components of embolic filter system 1000, such as elongate element 1200, can be color-coded to indicate the diameter of elongate element 1200, where a first color indicates a first diameter (e.g., 6 Fr) and a second color indicates a second, different diameter. Such color-coding allows a user to identify the appropriate diameter for use with a COTS delivery catheter in connection with an intravascular procedure.

[0136] It should be appreciated that the configurations discussed herein are scalable, in that they can be scaled up or down for various applications. That is, while certain configurations discussed herein are illustrated and described in relation to placement within the aortic arch, for example, the versatility of the systems allows them to be implemented in virtually any other area of ​​a patient's vasculature. For example, the various configurations discussed herein can be sized for use within various peripheral vessels and lumens, such as the brachiocephalic and / or carotid and / or subclavian arteries. Similarly, when referring to the aortic arch, the present disclosure can be used in relation to femoral, transapical, and open procedures. Furthermore, the present disclosure should not be construed as limited to vessels proximate to the heart. For example, the devices and systems described herein can be implemented throughout the body's vasculature, including vessels above and below the heart, to prevent the migration of embolic debris in various other revascularization procedures. Additionally, embodiments can be used in relation to various organs having internal anatomy in mammals, not just humans. Accordingly, the embodiments described herein encompass modifications and variations within the scope of the present disclosure. Thus, embolic filter system 1000 can be formed in a variety of sizes, and the size can optionally be based on the size of a COTS delivery catheter, such that embolic filter system 1000 can be manufactured in a variety of sizes for use in conjunction with a variety of COTS delivery catheters. As mentioned above, one or more components of embolic filter system 1000 can be color-coded based on its size.

[0137] The scope of the invention of this application has been described both generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Similarly, various components of the embodiments discussed herein can be combined. Accordingly, the embodiments are intended to encompass modifications and variations within the scope of the invention.

Claims

1. A medical device, an elongate element having a first end and a second end; an embolic filter assembly comprising a frame having a capture section distal to a mounting section, the capture section including a plurality of strut elements arranged to form a plurality of cells having cell edges, and at least one bending element operably coupled to and between cell edges of two adjacent cells of the plurality of cells such that the frame is operable to bend between the cell edges; A medical device comprising:

2. 10. The medical device of claim 1, wherein the capture section is radially expandable relative to the mounting section such that the embolic filter assembly is configured to transition from a compressed state toward an expanded state in situ.

3. 3. The medical device of claim 1 or 2, wherein the capture section includes a seal establishment zone operable to establish a seal with the patient's tissue and a bending zone operable to bend to conform to the shape of the patient's tortuous internal tissue structure.

4. The medical device of claim 3 , wherein the flexing elements define the flex zone in which the frame has greater flexibility than adjacent portions of the frame.

5. The medical device of any one of claims 1 to 4, wherein the bending element is serpentine having at least one curve in a first direction and at least one curve in a second direction opposite the first direction.

6. The medical device according to any one of claims 1 to 5, wherein the plurality of cells are closed cells.

7. The medical device of claim 6 , wherein each of the plurality of closed cells includes a first apex and a second apex opposite the first apex.

8. 8. The medical device of claim 7, wherein the at least one bending element is operably coupled between the proximal apex of a first closed cell of the plurality of closed cells and the distal apex of a second closed cell of the plurality of closed cells.

9. 9. The medical device of claim 8, wherein the plurality of closed cells form a first row of cells and a second row of cells along the longitudinal length of the frame, and wherein each distal apex of the plurality of closed cells of the first row of cells is operably coupled to each proximal apex of the plurality of closed cells of the second row of cells via the bending element.

10. The medical device of any of claims 1 to 9, wherein the at least one bending element is adapted to bend at a plurality of bending points between a first end and a second end of the bending element.

11. The medical device of any preceding claim, wherein the at least one bending element is adapted to extend in length.

12. 1. An embolic filter assembly for deployment in a lumen of a patient, said embolic filter comprising: a frame disposed about a longitudinal axis and operable to expand from a smaller collapsed configuration to a larger expanded configuration, the frame including a plurality of frame elements defining a sealing segment and a capture segment, the sealing segment configured to interface with the lumen of the patient, the capture segment including a bending element positioned between frame elements within the capture zone, the frame operable to bend farther from the longitudinal axis at the bending element than an adjacent portion of the frame not having a bending element; 1. An embolic filter comprising:

13. The embolic filter of claim 12, wherein the bending elements are aligned around the circumference of the frame at a common longitudinal position along the length of the frame.

14. 13. The embolic filter of claim 12, wherein the frame is operable to partially deploy such that the sealing segment is operable to expand to an expanded diameter when at least a portion of the capturing segment is maintained at a collapsed diameter.

15. 15. The embolic filter of claim 14, wherein the capture segment is operable to filter fluid flowing therethrough when the capture segment is partially deployed.

16. 13. The embolic filter of claim 12, wherein the frame is operable to angulate at a bending element to maintain the frame in an orthogonal orientation within the lumen when deployed.

17. 17. The embolic filter of claim 16, wherein the bending element comprises a curved, bent, zigzag, serpentine, or coiled shape.

18. The embolic filter of claim 12, wherein the frame element defines a plurality of closed cells, each closed cell including a proximal apex and a distal apex.

19. 20. The embolic filter of claim 18, wherein a first bending element is operably coupled between the proximal apex of a first closed cell of the plurality of closed cells and the distal apex of a second closed cell of the plurality of closed cells.

20. 1. An embolic filter assembly for deployment in a lumen of a patient, said embolic filter comprising: a frame disposed about a longitudinal axis and operable to expand from a smaller collapsed configuration to a larger expanded configuration, the frame including a plurality of frame elements defining a sealing segment and a capturing segment, the sealing segment configured to interface with the lumen of the patient, the capturing segment including a flexion element positioned between frame elements within the capturing segment, the frame operable to be partially deployed such that the sealing segment is operable to expand to an expanded diameter when at least a portion of the capturing segment is maintained at a collapsed diameter; 1. An embolic filter assembly comprising:

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