Embolic Filter System

Abstract

To provide a satisfactory system.SOLUTION: Various aspects of the present disclosure are directed toward an embolic filter system. The embolic filter system generally includes a filter and an elongate element. In some examples, the elongate element extends to a position distal to a proximal end of the filter and operates to protect against medical devices that become entangled with the filter. In some examples, the elongate element is flexible and compliant and operates with a hemostatic seal to provide the hemostatic seal within the lumen of the elongate element while maintaining the lumen as a working lumen through which a medical device can be passed.SELECTED DRAWING: Figure 1B

Description

[Background technology]

[0001] background Endovascular procedures address a wide range of medical needs, including intravascular access, diagnosis, and / or repair, by less invasive or relatively less invasive means than surgical approaches. During some endovascular procedures, embolic debris may become dislodged or circulate within the vasculature. Circulating embolic debris can cause mild to severe vascular complications, potentially leading to stroke and even death.

[0002] Some conventional embolic protection devices used in connection with such intravascular procedures trap embolic debris within the device. In some designs, the device must later be removed, leaving the embolic debris trapped within. However, a common risk with these procedures is that some or all of the trapped embolic debris may be unintentionally released back into the vasculature during the removal process.

[0003] Some other conventional embolic protection devices redirect embolic debris to areas of the vasculature where the presence of embolic debris is believed to pose a lower risk of harm to the patient. Diversion of embolic debris carries the risk of complications resulting from the migration of the redirected embolic debris to another anatomical region. Summary of the Invention

[0004] overview According to one example ("Example 1"), an embolic filter includes an elongate element having a proximal end and a distal end, and a filter portion disposed at the distal end of the elongate element; wherein the elongate element comprises a first structural element and a first covering material, the elongate element having sufficient structural integrity to support being advanced within a delivery sheath, and wherein the filter portion comprises a second structural element and a second covering material, a portion of the second covering material comprising a plurality of perforations configured to filter embolic debris from blood entering the filter portion.

[0005] According to yet another example ("Example 2") to Example 1, the first structural element is a self-expanding wire braid.

[0006] According to yet another example ("Example 3") to Examples 1-2, a distal force applied to the proximal end of the elongate element is operable to cause distal translation of the elongate element and filter portion relative to the delivery sheath.

[0007] According to yet another variation ("Example 4") to Examples 1-3, the elongate element has sufficient structural integrity to support being advanced within a delivery sheath without the need for an introducer.

[0008] According to yet another example ("Example 5") to Examples 1-4, the filter portion is blood permeable and the plurality of perforations have an average size of 100 microns.

[0009] According to yet another example ("Example 6") to Examples 1-5, the second coating material of the filter portion is blood impermeable and has a plurality of perforations formed therein such that blood can operatively flow through the second coating material of the filter portion.

[0010] According to yet another variation ("Example 7") to Examples 1-6, the elongate element is blood impermeable.

[0011] According to yet another example ("Example 8") to Examples 1-7, the elongate element is configured to be advanced through a valve that operates to control blood flow through the lumen of the elongate element during a clinical procedure.

[0012] According to yet another example ("Example 9") to Examples 1-8, one of the first and second coating materials includes ePTFE.

[0013] According to another example ("Example 10"), an embolic filter includes a filter assembly having two ends and an elongated intermediate section, and a structural element, wherein at a first end, the filter assembly includes an expandable filter element having an expandable frame and a filter material, wherein the intermediate section includes a thin, unsupported polymeric material configured to be mounted onto the structural element for advancement within a catheter lumen for delivery to a treatment site, and configured to remain at the treatment site while the structural element is removed.

[0014] According to yet another example ("Example 11") to Example 10, the structural element is configured to advance the first end of the filter assembly out of the end of the catheter for deployment at the treatment site.

[0015] According to yet another example ("Example 12") to Examples 10-11, the intermediate section is configured to be advanced through a valve that operates to control blood flow through the lumen of the intermediate section during a clinical procedure.

[0016] According to yet another example ("Example 13") to Example 12, the lumen of the intermediate section is configured to accommodate advancement of one or more medical devices therethrough during a clinical procedure, and the valve is configured to control blood flow through the lumen of the intermediate section during a clinical procedure.

[0017] According to yet another example ("Example 14") to Examples 10-13, the filter material is blood permeable and includes a plurality of perforations having an average size of 100 microns.

[0018] According to yet another variation ("Example 15") to Examples 10-14, the polymer material of the middle portion is blood impermeable.

[0019] According to yet another example ("Example 16") to Examples 10-15, one of the filter material and the polymeric material includes ePTFE.

[0020] According to another example ("Example 17"), an internal prosthesis delivery device includes an expandable filter element mounted on a catheter shaft, the expandable filter element having a capture region within the expandable filter element when the expandable filter element is deployed, and an elongate conduit configured to extend through and beyond the expandable filter element when the expandable filter element is deployed at a treatment site, wherein the conduit is configured to enable delivery of an internal protease beyond the expandable filter element, and wherein the elongate conduit includes at least one aperture through a sidewall providing fluid communication between the capture region and the interior of the elongate conduit.

[0021] According to yet another variation ("Example 18") to Example 17, the elongate conduit extends from the catheter shaft.

[0022] According to yet another alternative to Examples 17-18 ("Example 19"), the elongate conduit and catheter shaft form a single monolithic unit.

[0023] According to yet another example ("Example 20") to Examples 17-19, the at least one aperture is configured to facilitate movement of embolic debris trapped within the filter into the elongate conduit.

[0024] While multiple embodiments are disclosed, still 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 in nature and not restrictive. [Brief explanation of the drawings]

[0025] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification, illustrate examples, and together with the description, serve to explain the principles of the present disclosure.

[0026] [Figure 1A] FIG. 1A is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0027] [Figure 1B] FIG. 1B is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0028] [Figure 2] FIG. 2 is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0029] [Figure 3] FIG. 3 is a diagram of an introducer consistent with various aspects of the present disclosure.

[0030] [Figure 4A] FIG. 4A is a diagram of an embolic filter system consistent with various aspects of the present disclosure. [Figure 4B] FIG. 4B is a diagram of an embolic filter system consistent with various aspects of the present disclosure. [Figure 4C] FIG. 4C is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0031] [Figure 4D] FIG. 4D is a detailed view of various components of the embolic filter system shown in FIGS. 4A-4C.

[0032] [Figure 4E] FIG. 4E is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0033] [Figure 5A] FIG. 5A is a diagram of an embolic filter system being delivered within the aortic arch consistent with various aspects of the present disclosure.

[0034] [Figure 5B] FIG. 5B is an illustration of an embolic filter system deployed within the aortic arch consistent with various aspects of the present disclosure.

[0035] [Figure 5C] FIG. 5C includes a diagram of an embolic filter system deployed within the aortic arch consistent with various aspects of the present disclosure. [Figure 5D] FIG. 5D includes a diagram of an embolic filter system deployed within the aortic arch consistent with various aspects of the present disclosure.

[0036] [Figure 6A] FIG. 6A is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0037] [Figure 6B] FIG. 6B is a diagram of the embolic filter system of FIG. 6B in a deployed configuration consistent with various aspects of the present disclosure.

[0038] [Figure 7] FIG. 7 is a diagram of an embolic filter system consistent with various aspects of the present disclosure.

[0039] [Figure 8] FIG. 8 is a diagram of an embolic filter system consistent with various aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0040] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting. In describing various examples, the term distal is used to indicate a location along an example device that is proximal to or closest to the treatment region within a patient's body. The term proximal is used to indicate a location along an example device that is proximal to or closest to the user or operator of the device.

[0041] Various aspects of the present disclosure are directed to embolic filter devices, systems, and methods. An exemplary embolic filter system 1000 is shown in FIG. 1A. In some examples, the embolic filter system 1000 includes a distal end 1002 and a proximal end 1004. In some examples, the distal end 1002 is opposite the proximal end 1004.

[0042] In various examples, the embolic filter is deployed in a region of the patient's vasculature corresponding to the treatment site. Generally, the system is advanced to the target site such that one or more components of the system (e.g., the filter or deflector portion) are antegrade or "downstream" of the treatment. Those skilled in the art will appreciate that positioning the system in this manner causes emboli and other debris dislodged from the treatment region during the treatment procedure to migrate with the blood flow toward the system. The system is deployable, collapsible, and removable from the vasculature via either a distal or proximal approach direction (e.g., antegrade or retrograde), for example, to facilitate endovascular removal of the device from various access locations.

[0043] When deployed, embolic filter system 1000 interacts with blood flowing through a region of the vasculature in which it is deployed. In some instances, embolic filter system 1000 may be adapted or otherwise configured to filter blood and / or embolic debris as it flows through or interacts with embolic filter system 1000. In some instances, embolic filter system 1000 additionally or alternatively redirects blood flow and / or embolic debris that would otherwise result in normal or unimpeded flow of blood and / or embolic debris through the surrounding vasculature. Thus, in various instances, embolic filter system 1000 can be deployed within a region of a patient's vasculature such that blood and / or embolic debris is filtered and / or redirected as it flows through that region of the patient's vasculature.

[0044] In various examples, embolic filter system 1000 includes one or more components that work together to filter and / or redirect blood flow and embolic debris, as described above. For example, referring now to FIGS. 1A and 1B, embolic filter system 1000 includes elongate element 1100, filter 1200, and constraint element 1300. Various cutaways of constraint element 1300 are provided in FIGS. 1A and 1B to show portions of elongate element 1100 that would otherwise be obstructed by constraint element 1300. In some examples, elongate element 1100 acts as a conduit through which one or more medical devices can be delivered to a treatment site, as described in detail below. In some examples, constraint element 1300 is a catheter. In some examples, one or more components outside the patient's body are coupled to and work with elongate element 1100, filter 1200, and constraint element 1300. For example, one or more components 1400, such as a handle, a control unit, and / or a hemostasis valve, may be coupled to elongate element 1100, filter 1200, and restraining element 1300, as discussed in more detail below. In various examples, filter 1200 is coupled to elongate element 1100, and restraining element 1300 is configured to restrain elongate element 1100 and filter 1200 in a delivery (or collapsed) configuration.

[0045] In various examples, elongate element 1100 is a longitudinally extending structure having a distal end 1102, a proximal end 1104, and an intermediate portion 1106 located between the distal end 1102 and the proximal end 1104. In some examples, elongate element 1100 is configured to receive blood and / or embolic debris. In some such examples, elongate element 1100 filters and / or redirects blood and embolic debris flowing through the portion of the patient's vasculature in which embolic filter system 1000 is deployed. Accordingly, in various examples, elongate element 1100 includes an inner lumen, such as lumen 1108 (FIG. 1B). In some examples, blood and / or embolic debris entering elongate element 1100 flows through lumen 1108.

[0046] In various examples, lumen 1108 extends through elongate element 1100 from distal end 1102 to proximal end 1104. That is, in some examples, distal end 1102 and proximal end 1104 are open to lumen 1108. In some examples, lumen 1108 forms a working lumen through which one or more medical devices can be passed to a treatment site proximal to embolic filter system 1000. Thus, in various examples, lumen 1108 operates both as a working lumen for medical device delivery and as a structure for diverting and / or filtering blood flow and / or embolic debris flow.

[0047] Examples of medical devices that may be passed through lumen 1108 include, but are not limited to, catheters, thrombectomy devices, atherectomy devices, embolus removal devices and related instruments, contrast media, drug delivery agents, and intravascular prostheses, including, for example, stents, stent grafts, and valves. Additionally or alternatively, lumen 1108 may be configured to accommodate one or more release lines, steering lines, guidewires, structural support elements, and / or introducers and related components, as described further below.

[0048] In various examples, filter 1200 is a structure configured to interact with blood and / or embolic debris flowing through the patient's vasculature within the region in which embolic filter system 1000 is deployed. In some examples, filter 1200 is configured to direct or funnel the blood and embolic debris so that they enter filter 1200, and in some examples, elongate element 1100.

[0049] 1A and 1B, in some examples, the filter 1200 includes a membrane 1210 and a structural support 1212. The structural support 1212 may be formed from nitinol or other suitable material and may be laser cut, braided, or wound. In some examples, the structural support 1212 is formed from a laser cut nitinol tube, as will be understood by those skilled in the art.

[0050] In some examples, membrane 1210 is disposed about structural supports 1212. In some examples, structural supports 1212 are disposed about membrane 1210. In various examples, structural supports 1212 provide structural support to membrane 1210. In some examples, filter 1200 is self-expanding and / or radially collapsible, as discussed in more detail below. Filter 1200 may be of any size suitable for intravascular delivery and deployment.

[0051] In some instances, both the distal end 1202 and the proximal end 1204 of filter 1200 are open so that blood flow can enter filter 1200 at distal end 1202 and exit filter 1200 at proximal end 1204. Thus, in some instances, membrane 1210 is configured such that filter 1200 has a lumen extending therethrough. Generally, this lumen acts as a region for capturing blood and embolic debris. In some instances, proximal end 1204 of filter 1200 is coupled to elongate element 1100 such that blood exiting proximal end 1204 of filter 1200 enters or otherwise interacts with elongate element 1100.

[0052] In such instances, the bond between elongate element 1100 and filter 1200 can be permanent or temporary. In some instances, elongate element 1100 is bonded to filter 1200 such that elongate element 1100 and filter 1200 form a single monolithic unit. In some other instances, filter 1200 is removable from elongate element 1100. In some instances, filter 1200 is slidable relative to elongate element 1100.

[0053] In some instances, filter 1200 is coupled or otherwise secured to or near an end of elongate element 1100, such as distal end 1102 of elongate element 1100. For example, embolic filter system 1000 shown in FIG. 1A includes filter 1200 coupled to distal end 1102 of elongate element 1100.

[0054] However, in some other instances, filter 1200 is coupled to elongate element 1100 at a location along elongate element 1100 that is proximal to distal end 1102 of elongate element 1100. For example, the illustrated embolic filter system 1000 shown in FIG. 1B includes filter 1200 coupled to elongate element 1100 at a location along elongate element 1100 that is proximal to distal end 1102 of elongate element 1100. In some such instances, filter 1200 is coupled to elongate element 1100 such that distal end 1202 of filter 1200 is proximal to distal end 1102 of elongate element 1100. Thus, in some instances, distal end 1102 of elongate element 1100 extends distally to distal end 1202 of filter 1200, and thus corresponds to or otherwise defines distal end 1002 of embolic filter system 1000. As explained in more detail below, such distally projecting portion of elongate element 1100 protects against entanglement between filter 1200 and medical devices delivered to a treatment site through lumen 1108.

[0055] It will be appreciated that in some instances, filter 1200 is coupled to elongate element 1100 such that distal end 1102 of elongate element 1100 is located between distal end 1202 and proximal end 1204 of filter 1200. That is, filter 1200 is coupled to elongate element 1100 at a location along elongate element 1100 that is proximal to distal end 1102 of elongate element 1100, but distal end 1202 of filter 1200 corresponds to or otherwise defines distal end 1002 of embolic filter system 1000 (i.e., distal end 1202 of filter 1200 is distal to distal end 1102 of elongate element 1100). In some other instances, filter 1200 is coupled to elongate element 1100 such that distal end 1102 of elongate element 1100 and distal end 1202 of filter 1200 are located equidistantly distal to one another. In other words, distal end 1102 of elongate element 1100 is not (or is not substantially) located distal to distal end 1202 of filter 1200, or vice versa.

[0056] In some instances, the proximal end of the filter is coupled to the distal end of the first elongate element, and the second elongate element is coupled to the filter and / or the first elongate element such that the second elongate element extends within or through an interior region of the filter distal to the first elongate element. In some instances, similar to the discussion above, the distal end of the second elongate element is positioned distal to, at, or proximal to the distal end of the filter.

[0057] In some instances, filter 1200 deflects or otherwise redirects blood and / or embolic debris so that the blood and / or embolic debris flow into filter 1200. In some instances, filter 1200 operates to filter or otherwise condition the blood and embolic debris passing therethrough. In some instances, filter 1200 is permeable to certain blood media (e.g., blood-permeable) and impermeable to certain other blood media and / or embolic debris. Specifically, in some instances, membrane 1210 of filter 1200 is configured such that certain blood media (e.g., red blood cells, white blood cells, plasma, platelets, etc.) flowing through filter 1200 permeate membrane 1210 of filter 1200 and re-enter the vasculature, while filter 1200 is impermeable to certain other blood media and embolic debris. In some instances, filter 1200 is impermeable to embolic debris above a specified size, i.e., in some instances, membrane 1210 of filter 1200 operates to prevent embolic debris above a specified size from penetrating membrane 1210 of filter 1200 and re-entering the vasculature.

[0058] In some instances, blood media and embolic debris flowing through filter 1200 that does not permeate back into the vasculature is either captured and retained within filter 1200 or is further directed into elongate element 1100. In some instances, as described in more detail below, filter 1200 is collapsible so that blood media and embolic debris retained within filter 1200 can be subsequently removed from the patient's body.

[0059] As described above, in some instances, some or all of the blood and / or embolic debris flowing into filter 1200 is further directed toward elongate element 1100. In some instances, the blood and / or embolic debris directed toward elongate element 1100 enters lumen 1108 of elongate element 1100. In some instances, as described in more detail below, filter 1200 is configured to filter the blood and / or embolic debris that enters inner lumen 1108. Thus, in some instances, elongate element 1100 is configured to filter the blood and / or embolic debris that does not pass through filter 1200.

[0060] As described above, in some instances, filter 1200 and / or elongate element 1100 operate to filter embolic debris from the patient's blood flowing through embolic filter system 1000. Generally, the permeability of elongate element 1100 and / or membrane 1210 can be controlled by manipulating one or more of the material properties of the materials included in elongate element 1100 and / or membrane 1210. For example, the node-and-fibril configuration of the expanded fluoropolymer can be optimized based on the desired permeability. In some instances, the expanded fluoropolymer can be treated such that its node-and-fibril configuration is generally impermeable to embolic debris (and other blood media) of a specified size.

[0061] It will therefore be appreciated that the elongate element 1100 and filter 1200 can comprise a variety of materials, including, but not limited to, fluoropolymers such as expanded polytetrafluoroethylene ("ePTFE"), expanded PTFE, expanded modified PTFE, expanded copolymers of PTFE, polymers such as nylon, polycarbonate, polyethylene, polypropylene, and the like.

[0062] In various examples, one or more regions of a material may additionally or alternatively be modified by forming one or more perforations therein. For example, a material such as expanded fluoropolymer (or another suitable polymer) can be further modified by perforating one or more regions of the material to achieve a specified porosity in those regions. Examples include laser cutting holes or perforations into the material. Other materials with woven, knitted, or lattice configurations can also serve as suitable materials based on their permeability / porosity.

[0063] Additionally, in some instances, materials can be configured such that one or more portions or regions of the membrane 1210 of the elongate element 1100 and / or filter 1200 are permeable to media up to a specified size, while one or more other portions or regions of the elongate element 1100 and / or membrane 1210 are impermeable to the media. In some instances, the elongate element 1100 and / or filter 1200 can have variable pore or fenestrations sizes, for example, from the proximal end to the distal end and / or at one or more distinct locations (e.g., one or more transparency windows, as discussed below). For example, distal regions of the elongate element 1100 and / or filter 1200 can have a smaller average fenestrations size to avoid smaller embolic debris from entering larger blood vessels, while more proximal regions of the elongate element 1100 and / or filter 1200 can have a larger average fenestrations size beyond the point where smaller embolic debris entering larger blood vessels is not a concern.

[0064] In some instances, permeability can be varied by varying the number of layers of material along the elongate element 1100 and / or filter 1200. For example, a first region of material having a first number of expanded fluoropolymer layers is associated with a first degree of permeability, while a second region of material having a second number of expanded fluoropolymer layers is associated with a second degree of permeability. In some such instances, the permeability of such a region of material is inversely related to the number of expanded fluoropolymer layers incorporated into the material in that region.

[0065] In some other examples, varying degrees of permeability can be achieved alternatively or additionally by varying the diameter or area or perforation density of each of the perforations made in one region of the material relative to another region of the material. In one such example, a first region or area (e.g., distal) can be associated with one or more perforations having a first average perforation size, and a second region or area (e.g., proximal) can be associated with one or more perforations having a second average perforation size. Thus, in various examples, filter 1200 and / or elongate element 1100 can include regions or areas with variable pore sizes. It will be appreciated that by varying pore size or permeability, filtration of embolic debris along embolic filter system 1000 can be controlled, minimizing the risk of potentially harmful embolic debris perfusing critical areas.

[0066] In various examples, the perforation or pore sizes described above can be selected such that regions or sections of the elongate element 1100 and / or membrane 1210 of filter 1200 are impermeable to embolic debris of about 100 μm or greater. In such examples, it will be understood that the average pore size of such regions is less than 100 μm. However, in other examples, the pore size can be selected such that regions or sections of the material are impermeable to embolic debris of less than 100 μm, e.g., embolic debris in the range of 40 μm to 99 μm. In still other examples, other regions or sections of the material can be permeable to embolic debris greater than 100 μm, e.g., embolic debris in the range of 101 μm to 150 μm. It will be understood that the average pore size of such regions is 101 μm to 150 μm or greater.

[0067] 1A and 1B, in various examples, filter 1200 is expandable so that it occupies the region of the vessel in which it is deployed (or a substantial portion of that region). In various examples, filter 1200 is expanded once advanced to a target site at or proximate to the treatment region. Thus, in various examples, filter 1200 is transitionable between a radially collapsed delivery configuration and a radially expanded deployed configuration. In some examples, filter 1200 is self-expanding. In some examples, one or more expandable elements are utilized to transition filter 1200 between the radially collapsed delivery configuration and the radially expanded deployed configuration. For example, a balloon may be utilized to transition filter 1200 from the radially collapsed delivery configuration to the radially expanded deployed configuration.

[0068] In the deployed configuration, filter 1200 adopts a generally trumpet-shaped, conical, or frusto-conical shape in that the cross-sectional area of ​​filter 1200 is different at two different locations along filter 1200 between distal end 1202 and proximal end 1202 of filter 1200. In one such example, the cross-sectional area of ​​distal end 1202 is larger than the cross-sectional area of ​​proximal end 1204. In some examples, filter 1200 generally tapers from distal end 1202 to proximal end 1204. Such a configuration provides that filter 1200 operates to funnel blood into filter 1200 and / or elongate element 1100, as disclosed herein.

[0069] In some instances, one or more restraining members, such as restraining element 1300, operate to maintain filter 1200 and / or portions thereof in a radially collapsed delivery configuration. In some instances, restraining element 1300 is releasable or removable so that filter 1200 can be transitioned to a radially expanded deployed configuration.

[0070] In general, depending on the desired configuration, restraining element 1300 can comprise a variety of materials, including, but not limited to, fluoropolymers such as expanded polytetrafluoroethylene ("ePTFE"), expanded PTFE, expanded modified PTFE, expanded copolymers of PTFE, polymers such as nylon, polycarbonate, polyethylene, polypropylene, etc. Thus, in some examples, restraining element 1300 can be advanced or retracted relative to filter 1200.

[0071] 1A and 1B , in various examples, embolic filter system 1000 includes a restraining element 1300. In some examples, restraining element 1300 is an elongate member having a distal end 1302 and a proximal end 1304. In some examples, restraining element 1300 is cylindrical, although restraining elements having elliptical cross-sections are also contemplated. In various examples, an inner lumen 1306 extends through restraining element 1300 from distal end 1302 to proximal end 1304. In some examples, as described above, inner lumen 1306 is configured to receive elongate element 1100 therein. Thus, in some such examples, elongate element 1100 and restraining element 1300 are coaxial. Similarly, in various examples, a portion or all of filter 1200 is received within restraining element 1300 such that filter 1200 is maintained in a radially collapsed delivery configuration.

[0072] In various examples, elongate element 1100 is received within restraining element 1300 such that elongate element 1100 and restraining element 1300 can move relative to one another. As will be explained in more detail below, moving elongate element 1100 and restraining element 1300 relative to one another facilitates both deployment and collapse of filter 1200.

[0073] In some instances, restraining element 1300 is retractable such that distal end 1302 of restraining element 1300 translates proximally, away from distal end 1202 of filter 1200. In some such instances, elongate element 1100 and / or filter 1200 are held stationary while restraining element 1300 is retracted. In other instances, elongate element 1100 and / or filter 1200 are advanced while restraining element 1300 is retracted. In some instances, elongate element 1100 and / or filter 1200 are advanced relative to restraining element 1300 such that filter 1200 moves distally, away from proximal end 1304 of restraining element 1300. In some instances, restraining element 1300 is held stationary while elongate element 1100 and / or filter are advanced. In other instances, the restraining element 1300 is retracted while the elongate element 1100 and / or filter is advanced.

[0074] In various examples, advancing filter 1200 distally away from distal end 1302 of restraining element 1300 facilitates deployment of filter 1200. That is, by advancing filter 1200 distally away from distal end 1302 of restraining element 1300 and / or retracting distal end 1302 of restraining element 1300 away from distal end 1202 of filter 1200, filter 1200 can transition from a radially collapsed delivery configuration to a radially expanded deployed configuration.

[0075] As described above, in some instances, filter 1200 can be transitioned from a radially expanded, deployed configuration to a radially collapsed delivery configuration. In some instances, filter 1200 can be transitioned to the radially collapsed delivery configuration to withdraw embolic filter system 1000 from the patient's vasculature. In some instances, deployed filter 1200 is transitioned to the radially collapsed delivery configuration by advancing restraining element 1300 toward distal end 1202 of filter 1200 until filter 1200 is radially collapsed and retained by restraining element 1300, as discussed in more detail below. Alternatively or additionally, filter 1200 can be retracted proximally relative to restraining element 1300.

[0076] As mentioned above, in various examples, filter 1200 is coupled to elongate element 1100 at a location along elongate element 1100 proximal to distal end 1102 of elongate element 1100, such that distal end 1102 of elongate element 1100 is disposed distally relative to proximal end 1204 of filter 1200. With particular reference to FIG. 1B , exemplary embolic filter system 1000 includes elongate element 1100 having a distal end 1102 disposed distally relative to proximal end 1204 of filter 1200, such that distal portion 1110 of elongate element 1100 extends distally beyond proximal end 1204 of filter 1200. As mentioned above, in various examples, elongate element 1100 includes an inner lumen 1108 through which one or more medical devices can be delivered to a treatment site located distal to distal end 1002 of embolic filter system 1000.

[0077] In some instances, distal portion 1110 provides the ability to deliver such medical devices with reduced risk of such medical devices becoming entangled with filter 1200. In other words, the portion of the elongate element extending distally relative to proximal end 1204 of filter 1200 (distal portion 1110) acts as a barrier between the medical device being delivered and filter 1200. Thus, such a configuration is associated with a reduced risk of the medical device being delivered interfering with filter 1200 as it emerges from distal end 1102 of elongate element 1100. One skilled in the art will appreciate that such a configuration helps minimize the risk of a medical device becoming entangled with filter 1200 and tearing or otherwise damaging filter 1200.

[0078] In addition to protecting against entanglement between filter 1200 and the medical device being delivered, in some instances, distal portion 1110 of elongate element 1100 acts to capture embolic material trapped in filter 1200 when the filter is radially collapsed for removal of embolic filter system 1000. Specifically, in some instances, distal portion 1110 includes one or more apertures 1112 extending from an outer surface 1114 of distal portion 1110 to inner lumen 1108 of elongate element 1100. Thus, one or more apertures 1112 provide a passageway for embolic debris captured by filter 1200 to enter lumen 1108. In some instances, such a configuration may additionally or alternatively facilitate aspiration of embolic debris from embolic filter system 1000. In some such instances, aspiration of embolic debris can be accomplished before or after radially collapsing filter 1200 and / or withdrawing embolic filter 1000 from the patient's vasculature. Those skilled in the art will appreciate that by providing a mechanism for expelling embolic debris that may have been trapped within filter 1200, embolic filter system 1000 helps minimize the risk of trapped embolic debris being inadvertently released back into the patient's vasculature during withdrawal of embolic filter system 1000 from the patient's vasculature.

[0079] For example, a known risk during embolic debris filtration procedures is the risk of tearing the filter (or filter material) during withdrawal. Generally, an embolic filter filled with embolic debris generally occupies a larger cross-sectional area than an embolic filter without embolic debris. This increased cross-sectional area may be associated with difficulty in sufficiently collapsing the embolic filter into a configuration that allows it to be fully retracted into a constraining sheath. Even when the filter is not retracted into a constraining sheath, it may be difficult to withdraw a filter having a larger diameter as a result of being filled with embolic debris through tortuous vasculature. Providing a mechanism that allows for the expulsion of some or all of the embolic debris from the filter helps minimize this risk.

[0080] In some instances, the cross-sectional area of ​​the distal portion 1110 of the elongate element 1100 is smaller than the cross-sectional area of ​​the portion of the elongate element 1100 located proximal to the proximal end 1204 of the filter 1200. In some such instances, the distal portion 1110 of the elongate element 1100 has an outer diameter that is smaller than the outer diameter of the portion of the elongate element 1100 located proximal to the proximal end 1204 of the filter 1200. However, in one such instance, the inner diameter of the distal portion 1110 is the same (or substantially the same) as the inner diameter of the portion of the elongate element 1100 located proximal to the proximal end 1204 of the filter 1200. In other words, the cross-sectional area (or outer diameter) of the distal portion 1110 is smaller than that of the portion of the elongate element 1100 located proximal to the proximal end 1204 of the filter 1200, but the diameter or cross-sectional area of ​​the inner lumen 1108 is generally constant between the distal end 1102 and the proximal end 1104 of the elongate element 1100. It will therefore be understood that in some instances, the elongate element 1100 has a varying wall thickness along its length.

[0081] In other words, in some examples, the distal portion 1110 has a first inner diameter and a first outer diameter, and the portion of the elongate element 1100 located proximal to the proximal end 1204 of the filter 1200 has a first inner diameter and a second outer diameter, where the second outer diameter is larger than the first outer diameter.

[0082] 2 and 3, various components of embolic filter system 2000 are shown. As shown, embolic filter system 2000 includes elongate element 2100, filter 2200 (similar to filter 1200), and introducer 2300. As shown in FIG. 4, in some instances, embolic filter system 2000 further includes restraining member 2400 (similar to restraining element 1300) and hemostatic sealing member 2500.

[0083] Similar to elongate element 1100, in various examples, elongate element 2100 can comprise a variety of materials, including, but not limited to, fluoropolymers such as expanded polytetrafluoroethylene ("ePTFE"), expanded PTFE, expanded modified PTFE, expanded copolymers of PTFE, polymers such as nylon, polycarbonate, polyethylene, polypropylene, and the like. Similar to elongate element 1100, elongate element 2100 extends longitudinally and includes a distal end 2102, a proximal end 2104, and an intermediate portion 2106 located between distal end 2102 and proximal end 2104. In some examples, elongate element 2100 is configured to receive blood and / or embolic debris. In some such examples, elongate element 2100 filters and / or redirects blood and embolic debris flowing through a portion of the patient's vasculature in which embolic filter system 2000 is deployed. Thus, in various examples, elongate element 2100 includes an internal lumen, such as lumen 2108 (FIG. 2).

[0084] In various examples, lumen 2108 extends through elongate element 2100 from distal end 2102 to proximal end 2104. That is, in some examples, distal end 2102 and proximal end 2104 are open to lumen 2108. In some examples, lumen 2108 forms a working lumen through which one or more medical devices can be passed to a treatment site proximal to embolic filter system 2000, as described above.

[0085] In some examples, the elongate element 2100 is formed from a material such as an expanded fluoropolymer, such as ePTFE. Thus, in some examples, the elongate element 2100 is a soft, compliant material. In some examples, the elongate element 2100 lacks sufficient structural rigidity to support its own weight and has little or no column strength when subjected to longitudinal compressive forces. Similarly, in some such examples, the elongate element 2100 is generally torque-resistant, in that it generally does not transmit a torque applied to its first end to its second end. However, as will be understood by those skilled in the art, elongate element 2100 made from expanded fluoropolymer exhibits good tensile strength, in that a longitudinal tensile force applied to a first end of the elongate element 2100 is generally transmitted along the elongate element 2100.

[0086] Elongate elements formed from fluoropolymers such as ePTFE have an additional advantage over other materials and designs in that they can have working lumens with diameters larger than those of conventional designs without increasing the outer working diameter of the system. In other words, elongate elements formed from fluoropolymers such as ePTFE can be constructed with thin or very thin walls (e.g., in the range of 0.0001 to 0.010 inches) to maximize the inner diameter of the working lumen without affecting the overall size of the device. For example, in some instances, elongate elements formed from fluoropolymers such as ePTFE can be constructed with an average wall thickness of about 0.001 inches. It should be understood that the high tensile strength of fluoropolymers such as ePTFE allows for construction with thin walls that maximize the area of ​​the working lumen (as discussed further herein).

[0087] In some instances, like elongate element 1100, elongate element 2100 can be blood-permeable while remaining impermeable to embolic debris and other blood media above a certain size or cross-section. Similarly, like elongate element 1100, elongate element 2100 can include one or more perforations and / or varying permeabilities or porosities along its length.

[0088] In some instances, as described in more detail below, the elongate element 2100 includes a stop mechanism 2112 ( FIG. 2 ). In some instances, the stop mechanism 2112 is integral with the elongate element 2100. In other instances, the stop mechanism 2112 is a separate component coupled to the elongate element 2100. In some instances, the stop mechanism 2112 is located at or near the proximal end 2104 of the elongate element 2100. In some instances, the stop mechanism 2112 operates to control how far the elongate element 2100 can be advanced through the vasculature. In some instances, the stop mechanism 2112 additionally or alternatively operates as a tensioning mechanism for withdrawing the elongate element 2100 and filter 2200 from the vasculature. Thus, in some instances, the stop mechanism 2112 operates as a capture mechanism that captures the elongate element 2100 and filter 2200 to facilitate withdrawal from the vasculature. In some examples, the stop mechanism 2112 is rigid or semi-rigid and may be formed from a polymer such as, for example, polypropylene, polyethylene, polyamide, polyetheretherketone, or other suitable plastic.

[0089] In various examples, similar to filter 1200, filter 2200 is a structure configured to interact with blood and / or embolic debris flowing through a patient's vasculature within the region in which embolic filter device 2000 is deployed. In various examples, filter 2200 includes a distal end 2202, a proximal end 2204, and an intermediate portion 2206. Similarly, in some examples, filter 2200 includes a membrane 2210 and a structural support 2212. Thus, in some examples, similar to filter 1200, filter 2200 is self-expanding and / or radially collapsible.

[0090] In some instances, both distal end 2202 and proximal end 2204 of filter 2200 are open so that blood flow can enter the filter at distal end 2202 and exit the filter at proximal end 2204. In some instances, proximal end 2204 of filter 2200 is coupled to elongate element 2100 so that blood exiting proximal end 2204 of filter 2200 enters or otherwise interacts with elongate element 2100. In such instances, the coupling between elongate element 2100 and filter 2200 may be permanent or temporary, as described above with respect to elongate element 1100.

[0091] Additionally, similar to filter 1200, in some instances, filter 2200 operates to filter or otherwise condition blood and embolic debris flowing therethrough. Thus, in some instances, filter 2200 is permeable to certain blood media (e.g., blood-permeable) and impermeable to certain other blood media and / or embolic debris (e.g., embolic debris and blood media above a specified size). Similarly, one or more regions can be permeable, while one or more other regions can be impermeable (or less permeable as discussed herein). In some instances, as described in more detail below, filter 2200 is collapsible, so that blood media and embolic debris retained within filter 2200 can then be removed from the patient's body.

[0092] As described above, the permeability / porosity of an elongate element or filter, such as elongate element 2100 and / or filter 2200, can be controlled by manipulating one or more material properties (e.g., node-and-fibril configuration, perforation, woven, knitted, and lattice configuration) of the material that the elongate element and / or filter comprises.

[0093] As shown in FIG. 2 , filter 2200 includes a plurality of perforations 2208. In some examples, these perforations 2208 are configured to filter embolic debris from a patient's blood. For example, perforations 2208 may be 50 microns to 1000 microns in size and thus operable to filter debris as small as 50 microns. While the perforations are shown as generally circular geometric shapes, it will be understood that other shapes, e.g., polygonal shapes, are contemplated and may be utilized in addition to or in place of circular geometric shapes without departing from the spirit or scope of the present disclosure. As discussed above, perforations 2208 (and / or node-and-fibril configurations and / or woven and / or braided and / or lattice configurations and / or laminations, etc.) may vary across the material (e.g., from the proximal end to the distal end and / or at one or more distinct locations). Furthermore, while filter 2200 shown in FIG. 2 shows perforations along only a portion thereof, it will be understood that perforations may be included on any and all surfaces of filter 2200.

[0094] 3 , in various examples, introducer 2300 is a longitudinally extending structure configured to facilitate delivery of an embolic filter system to a treatment site (or a location proximal thereto) within a patient's vasculature. Specifically, in some examples, introducer 2300 is configured so that elongate element 2100 and filter 2200 can be loaded onto the introducer and delivered to a treatment site within a patient's vasculature. As shown, the exemplary introducer 2300 includes a distal end 2302 and a proximal end 2304. In some examples, an intermediate section 2306 is located between the distal end 2302 and the proximal end 2304. In some examples, introducer 2300 includes an elongate element mounting section 2308 and a filter mounting section 2310. In some examples, intermediate section 2306 includes the elongate element mounting section 2308 and the filter mounting section 2310.

[0095] In some examples, the introducer 2300 is generally cylindrical, although other profiles are contemplated. Additionally, in some examples, the introducer 2300 can have any suitable cross-sectional profile, including, but not limited to, circular and elliptical cross-sections. In some examples, the introducer 2300 includes a blunt tip at its distal end 2302. In some examples, the proximal end 2304 includes a generally tapered tip. For example, as shown in FIGS. 4A and 4B , the introducer 2300 includes a tapered tip 2312 having a distal end 2314 with a smaller cross-section than the proximal end 2316. In some examples, the distal end 2314 of the tapered tip 2312 corresponds to the distal end 2304 of the introducer 2300. In some examples, the tapered tip 2312 extends from and is disposed distal to the filter mounting portion 2310.

[0096] As discussed above, introducer 2300 is configured to facilitate delivery of elongate element 2100 and filter 2200 to a treatment site (or a location proximal thereto) so that elongate element 2100 and filter 2200 can operate to filter embolic debris from the patient's blood. Those skilled in the art will appreciate that, due to its flexible and compliant nature, elongate element 2100 cannot be easily advanced through the vasculature without the assistance of introducer 2300. In short, when elongate element 2100 is not attached to introducer 2300, applying a distal force to proximal end 2104 of elongate element 2100 will have little, if any, effect on translating the distal end of elongate element 2100. Under such circumstances, those skilled in the art will appreciate that elongate element 2100 will buckle (or accordion) along its longitudinal length. Thus, in the case of a flexible, compliant elongate element, such as elongate element 2100, introducer 2300 is utilized to advance the elongate element (and thus filter 2200) through the patient's vasculature to the target site.

[0097] In some instances, the elongate element mounting portion 2308 of the introducer 2300 is complementary (e.g., length, shape, cross-sectional area, etc.) to the elongate element 2100 so that the elongate element 2100 can be mounted thereon. In some instances, the elongate element mounting portion 2308 is a smooth, continuous surface. In some such instances, when mounted to the introducer 2300, the elongate element 2100 is supported by the elongate element mounting portion 2308 of the introducer 2300.

[0098] Similarly, in some examples, the filter mounting portion 2310 of the introducer 2300 is complementary (e.g., length, shape, cross-sectional area, etc.) to the filter 2200 when the filter 2200 is radially collapsed and configured for delivery. In some examples, the filter mounting portion 2310 is formed as a relief in the introducer 2300. In some examples, the relief is a circumferential relief, but need not be. In some examples, as will be understood by those skilled in the art, a removable constraining sheath is disposed around at least the filter and / or elongate element to maintain the filter and / or elongate element in a delivery configuration on the introducer. In such examples, the constraining sheath can be removed when the elongate element and filter have been delivered to the target site, allowing the filter to expand to its radially expanded, deployed configuration. In various examples, the removable constraining sheath can be a sleeve, sheath, sock, or other constraining mechanism. Those skilled in the art will appreciate that deployment of the filter can occur proximal to distal, distal to proximal, end to interior, middle to exterior, and the like.

[0099] In some instances, when filter 2200 is radially folded and mounted thereon, the radially folded filter 2200 is received within the relief. For example, the relief has a radial depth sufficient to accommodate the membrane and / or structural elements of the filter such that the radially folded filter does not protrude radially beyond the elongate elements disposed about (or mounted on) elongate element mounting portion 2308. Such a configuration provides a system with a minimal delivery profile.

[0100] In some instances, the position of the elongate element and filter along the introducer is maintained during delivery as a result of the radially folded filter being received within the circumferential relief. Specifically, as will be understood by those skilled in the art, when the filter is radially folded and received by the filter mount, forces applied to the introducer are transmitted to the filter by the relief. Thus, when the filter is radially folded and received by the filter mount, translational motion of the introducer is transmitted to the filter, causing the filter and elongate element to translate with the introducer.

[0101] 4A-4C illustrate embolic filter system 2000. FIG. 4A is a diagram of exemplary embolic filter system 2000 shown in a delivery configuration. As mentioned above, in some instances, elongate element 2100 and filter 2200 are attached to introducer 2300. Introducer 2300, with elongate element 2100 and filter 2200 attached, is positioned within a constraining sheath such that elongate element 2100 and filter 2200 are configured for delivery to a target site within a patient's vasculature. Specifically, as shown in FIG. 4A, filter 2200 is in a radially collapsed delivery configuration. As mentioned above, in some instances, elongate element 2100 and / or filter 2200 can be advanced relative to constraining member 2400 to facilitate delivery of filter 2200 and elongate element 2100 to a target site. In some instances, restraining element 2400 remains stationary while elongate element 2100 and / or filter 2200 are advanced. In some instances, as described above, elongate element 2100 and / or filter 2200 are advanced by advancing introducer 2300 to which filter 2200 and / or elongate element 2100 are attached.

[0102] 4B is an illustration of exemplary embolic filter system 2000 after introducer 2300 has been advanced distally relative to constraining element 2400. Specifically, as shown, introducer 2300 has been advanced relative to constraining element 2400 such that filter 2200 has been advanced distally beyond distal end 2402 of constraining element 2400. Thus, once filter 2200 has been advanced distally beyond distal end 2402 of constraining element 2400, filter 2200 is free to expand to its radially expanded, deployed configuration. However, in some instances, removal of an additional constraining sheath may be required.

[0103] In some instances, introducer 2300 can be withdrawn after filter 2200 has expanded to its radially expanded, deployed configuration. That is, after filter 2200 has expanded to its radially expanded, deployed configuration, introducer 2300 can be withdrawn without displacing the position of filter 2200 and / or elongate element 2100 within the vasculature. In some instances, once filter 2200 has expanded to its radially expanded, deployed configuration, filter 2200 is not received or otherwise attached by the filter mounting portion (e.g., filter 2200 is no longer received within the circumferential relief). Thus, as the introducer translates, features of the introducer (e.g., the filter mounting portion) do not sufficiently engage the elongate element or filter to translate the elongate element or filter with the introducer.

[0104] 4C, introducer 2300 has been removed from elongate element 2100 and filter 2200. In some instances, with introducer 2300 removed, blood flowing through the vasculature in which embolic filter system 2000 is deployed flows into filter 2200 and / or elongate element 2100. In some instances, this blood flow is sufficient to expand elongate element 2100 or otherwise prevent elongate element 2100 from collapsing under its own weight. That is, in instances where elongate element 2100 is a soft, compliant material that would not otherwise be able to support its own weight, the blood flowing into elongate element 2100 applies sufficient pressure to the inside of the lumen to expand elongate element 2100 or otherwise prevent elongate element 2100 from collapsing. As discussed above, the elongate element can include one or more blood-permeable regions. Similarly, although not shown, in some instances, the restraining element 2400 can be retracted along part (or all) of the length of the elongate element 2100 to allow blood to perfuse through the elongate element 2100 and re-enter the vasculature. It will also be appreciated that in some instances, the restraining element includes one or more blood-permeable regions or zones.

[0105] In some examples, the embolic filter system 2000 includes a hemostatic seal member 2500, as described above. Generally, a hemostatic seal member operates to maintain a hemostatic seal and allow one or more medical devices to pass therethrough with minimal blood loss. Examples of hemostatic seal members can be found in at least U.S. Patent No. 9,314,605, issued April 19, 2016, and U.S. Patent Application Publication No. 2013 / 0123705, having U.S. Patent Application No. 13 / 677,839, scheduled to issue February 7, 2017, as U.S. Patent No. 9,561,347, the entire contents of each of which are incorporated herein by reference.

[0106] In some instances, the flexible, compliant elongate element 2100 operates in conjunction with the hemostatic seal member 2500 to maintain a hemostatic seal while allowing one or more medical devices to be advanced through the working lumen of the elongate element 2100 to a treatment site, as described above. Specifically, with reference to FIG. 4D , a cross-sectional view of the hemostatic seal member 2500 and elongate element 2100 is shown. As shown, the hemostatic seal member includes one or more pressure elements 2502 that operate to form a hemostatic seal inside the hemostatic seal member 2500. In some instances, these pressure elements 2502 of the hemostatic seal member 2500 operate to collapse the flexible, compliant elongate element 2100 as it passes through the hemostatic seal member 2500. In these examples, the pressure exerted on the inside of the elongate element 2100 by the blood therein is insufficient to overcome the pressure exerted by the pressurizing element 2502 which acts to collapse the lumen 2108 of the elongate element 2100 in the area passing through the hemostatic seal member 2500.

[0107] 4D , the lumen 2108 of the elongate element 2100 is expanded on the distal side 2504 of the hemostatic seal member 2500 by pressure exerted on the inside of the lumen 2108 of the elongate element 2100 by the blood therein. Similarly, as shown, the elongate element 2100 is structurally supported by a stop mechanism 2112 coupled to the material of the elongate element 2100 on the proximal side 2506 of the hemostatic seal member 2500.

[0108] Those skilled in the art will appreciate that when a medical device is introduced into the lumen 2108 of the elongate element 2100 on the proximal side 2506 of the hemostatic seal member 2500 and advanced therethrough to the distal side 2504, the pressure element 2502 applies pressure to the elongate element 2100, causing the elongate element 2100 to form a hemostatic seal between the interior of the lumen 2108 and the medical device advanced therethrough.

[0109] Thus, the flexible, compliant elongate element 2100 can be utilized by a hemostatic seal (such as the hemostatic seal described above) such that a hemostatic seal is formed through the lumen 2108 of the elongate element 2100, while maintaining the lumen 2108 as a working lumen through which one or more medical devices can be passed and delivered from a location outside the patient's body to a treatment site. In some examples, the flexible, compliant elongate element 2100 can be utilized by a hemostatic seal such that a hemostatic seal is formed both between the hemostatic seal and an outer surface of the elongate element 2100 and within the lumen 2108 of the elongate element 2100 (e.g., by collapsing an inner lumen).

[0110] Referring now to FIG. 4E, the withdrawal of elongate element 2100 and filter 2200 is illustrated. In some instances, an introducer 2300 is utilized to deliver the flexible, compliant elongate element 2100 and filter 2200 to a target site within a patient's vasculature, but the elongate element 2100 and filter 2200 may be withdrawn or otherwise removed therefrom without the use of the introducer 2300. Specifically, in some instances, a pulling force 2600 may be applied to the proximal end 2104 of the elongate element 2100 to withdraw the elongate element 2100 and filter 2200 from the target site. As noted above, the elongate element 2100, while flexible and compliant, is constructed from a material having sufficient tensile strength to permit such withdrawal from the target site, as will be understood by those skilled in the art. In at least some instances, some contemplated materials are associated with tensile strength characteristics of 1400-7000 psi. However, other materials having higher and lower tensile strengths are contemplated.

[0111] 4E , as elongate element 2100 and filter 2200 are withdrawn, filter 2200 collapses radially as it is withdrawn into restraining element 2400. In some instances, restraining element 2400 is sufficiently rigid to collapse filter 2200 radially. In some instances, embolic debris captured by elongate element 2100 and filter 2200 is retained within elongate element 2100 and filter 2200 during removal of elongate element 2100 and filter 2200 from the vasculature. However, in some instances, embolic debris captured within filter 2200 and elongate element 2100 can additionally or alternatively be aspirated prior to withdrawal. Such a configuration helps minimize the likelihood of trapped embolic debris being released back into the vasculature when filter 2200 and elongate element 2100 are withdrawn.

[0112] In some instances, elongate element 2100 and filter 2200 can be withdrawn such that filter 2200 passes through hemostatic seal member 2500. In some instances, hemostatic seal member 2500 is coupled to restraining member 2400. Thus, in some instances, elongate element 2100 and filter 2200 can be withdrawn from the vasculature independently of withdrawal of restraining element 2400. In some such instances, hemostatic seal member 2500 operates to minimize blood loss through embolic filter system 2000 and maintain a hemostatic seal as elongate element 2100 and filter 2200 are withdrawn through hemostatic seal member 2500.

[0113] Referring now to FIG. 5A , embolic filter system 5000 is shown in a delivery configuration within aortic arch 5502. Embolic filter system 5000 may be any of the embolic filter systems illustrated and described herein. As shown, embolic filter system 5000 is advanced through a patient's vasculature to a target site. In this illustrated example, embolic filter system 5000 is advanced to a location within aortic arch 5502 at or near ascending aorta 5510. In some instances, embolic filter system 5000 is in a delivery configuration advanced through a patient's vasculature and delivered to a target site. As discussed in more detail above, when in the delivery configuration, the elongate element and filter are received (or at least partially received) within a restraining member, such as restraining element 5300. As shown, in some instances, embolic filter system 5000 is guided along guidewire 5600.

[0114] In some instances, after the embolic filter system has advanced to the target site, the filter and elongate element are deployed. Referring now to FIG. 5B, the embolic filter system 5000 is shown partially deployed in the aortic arch 5502. Specifically, the restraining element 5300 has been partially withdrawn to a position proximal to the proximal end of the filter 5200, transitioning the filter 5200 to its deployed configuration. In the deployed configuration, as shown in FIG. 5B, the distal end 5202 of the filter 5200 has a cross-sectional area substantially equal to the cross-sectional area of ​​the portion of the aorta in which the filter 5200 is deployed. In this illustrated example, the filter 5200 contacts some or all of the wall of the aortic arch 5502 in the region in which the filter 5200 is deployed. As a result, the filter 5200 operates to direct blood flowing from the ascending aorta 5510 toward the filter 5200.

[0115] 5C shows filter 5200 and elongate element 5100 with restraining element 5300 withdrawn therefrom (or at least withdrawn to a location distal to the aortic arch 5502). In some instances, filter 5200 is blood permeable, thereby permitting perfusion of blood into the brachiocephalic artery 5504, carotid artery 5506, and subclavian artery 5508, as well as through the aortic arch 5502 to the descending aorta 5512 and downstream vasculature. Additionally, elongate element 5100 is shown as including a blood permeable window 5150. Thus, blood can be perfused from blood permeable window 5150 to at least the subclavian artery 5508.

[0116] As noted above, the degree of permeability of the embolic filter system can vary along the length of the filter and / or elongate element. In the illustrated example of FIG. 5C , the blood-permeable window 5150 may be configured to be permeable to particles to which the filter is impermeable. Thus, larger particles that did not penetrate the filter 5200 can penetrate the blood-permeable window 5150. As explained above, one way to achieve this result involves configuring the filter with a plurality of first perforations having a first average size and configuring the blood-permeable window with a plurality of second perforations having a second average size larger than the average size of the plurality of first perforations. While certain of the above examples include filters (e.g., 1200) that have some degree of blood permeability, in some instances the filter can be impermeable to blood such that the filter instead acts as a deflector that directs blood and other media (e.g., embolic debris) into the elongate element.

[0117] As discussed above, in some examples, a distal portion of the elongate element can extend distally from the proximal end of the filter and can act as a working lumen. In the illustrated example of FIG. 5D , the distal portion 5110 of the elongate element 5100 extends distally from the proximal end 5204 of the filter 5200. As shown, the working lumen 5108 of the elongate element 5100 provides a mechanism for delivery of one or more medical devices, such as medical device 5700, to a treatment site. In the illustrated example of FIG. 5D , the distal portion 5110 acts to prevent entanglement between the medical device 5700 and the filter 5200, as discussed above.

[0118] As described above, in various examples, the elongate element and / or filter operates to filter embolic debris and other blood media from the patient's blood. In some such examples, the elongate element and / or filter is formed from a substantially permeable material and / or includes one or more perforations. Similarly, as described above, in some examples, the elongate element and / or filter is configured such that the elongate element and / or filter is permeable (e.g., blood-permeable) at one or more distinct locations. In some examples, the elongate element and / or filter can be configured to be blood-permeable at some locations and blood-impermeable at other locations. In some examples, the elongate element and / or filter includes one or more filtering windows configured to further filter blood and embolic debris.

[0119] In general, the permeable window (e.g., blood permeable) can be located anywhere along or around the elongate element or filter and can have a variety of suitable dimensions (including, but not limited to, circular, oval, elongated, spiral, random, etc.) In some instances, the elongate element or filter can include at least one window having a greater porosity than adjacent portions of the elongate element or filter.

[0120] In various instances, one or more transmission windows (e.g., blood permeability) can be used to reduce or eliminate the possibility of stagnant blood columns within the elongate element or filter. For example, in some instances, stagnant, trapped embolic debris can reduce porosity and increase pressure gradients across the elongate element or filter. As a result, stagnant embolic debris can accumulate over time and reduce filtration efficiency, which can be particularly problematic. On the other hand, elongate elements with one or more transmission windows (e.g., blood permeability) can allow blood and redirected embolic debris to migrate into their lumen, where collection does not adversely affect filtration efficiency and removal by suction can be performed by the operator.

[0121] In various examples, the transmissive window can include a one-way flap or valve to prevent blood from entering during, for example, aspiration procedures while allowing blood perfusion therethrough. In some examples, the one-way valve can include a biocompatible material (e.g., a fluoropolymer) having one or more slits and biased to open in one direction. In some examples, the one-way flap can include a biocompatible material (e.g., a fluoropolymer) having a support frame. In some examples, the one-way flap or valve can be disposed on the outer and / or inner surface of the transmissive window (e.g., blood permeable) so as to substantially cover the window.

[0122] As described above, in various examples, the filter includes a structural element. In various examples, the structural element includes one or more support elements, such as one or more braids, meshes, lattices, wires, rings, studs, or any other suitable support element. In some examples, the support element is tubular and can be laser cut or separately formed. In some examples, as will be appreciated by those skilled in the art, one or more support elements can be formed from a shape memory material, such as Nitinol, such that the structural element is a self-expanding structural element. However, in other examples, one or more support elements can be formed from other elastic metals that can be expandable through the use of an expansion aid (e.g., a balloon). For example, one or more support elements can be formed from a polymer or a biocompatible metal alloy, such as stainless steel.

[0123] Furthermore, those skilled in the art will understand that the configurations discussed herein are scalable, in that they can be expanded or contracted to accommodate different applications. That is, while certain configurations discussed herein are illustrated and described in connection with placement within the aortic arch, the versatility of the system allows for implementation in virtually any other area of ​​a patient's vasculature. For example, the various configurations discussed herein can be scaled for application within various peripheral vessels and lumens, such as the brachiocephalic and / or carotid and / or subclavian arteries. Similarly, while the configurations relate to the aortic arch, the present disclosure can be used in connection with femoral, transapical, and open approaches. Furthermore, the present disclosure should not be construed as limiting application to vessels proximal to the heart. For example, the devices and systems described herein can be implemented throughout the body's vasculature, including the vasculature above and below the heart, to prevent migration of embolic debris during various other revascularization procedures. Furthermore, embodiments can be used with various organisms having mammalian anatomy, not just humans. Accordingly, the embodiments described herein are intended to cover modifications and variations within the scope of the present disclosure.

[0124] Additionally, in some instances, multiple devices or systems may be deployed for a given procedure. For example, in some cardiac procedures, one of the devices described herein may be placed in the aortic arch and / or the brachiocephalic and / or carotid and / or subclavian arteries.

[0125] 6A and 6B, an embolic filter system 6000 is shown. In various examples, the embolic filter system 6000 includes a first elongate element 6100, a filter portion 6200, and a second elongate element 6300. As shown, the embolic filter system 6000 includes a distal end 6002 and a proximal end 6004. Similarly, in some examples, the first elongate element 6100 includes a distal end 6102 (obscured from view by the distal end of the second elongate element 6300) and a proximal end 6104, and the second elongate element 6300 includes a distal end 6302 and a proximal end 6304. In various examples, each of the first elongate element and the second elongate element has a lumen extending therethrough. For example, the first elongate element includes an inner lumen 6106, and the second elongate element includes an inner lumen 6306 (obscured from view). In some instances, the inner lumen 6106 of the first elongate element acts as a working lumen as described herein.

[0126] In some examples, the first elongate element 6100 is disposed within the inner lumen of the second elongate element 6300 such that the first elongate element 6100 and the second elongate element 6300 are coaxial. As shown in Figures 6A and 6B, the first elongate element 6100 extends between the distal end and the proximal end of the second elongate element 6300. In some examples, the distal end 6102 of the first elongate element 6100 is aligned with the distal end of the second elongate element.

[0127] In some instances, the second elongate element 6300 is a longitudinally extending structure having a lumen extending therethrough, as described above. In some instances, the second elongate element 6300 includes a deployable filter portion 6200 that includes one or more support elements, such as support elements 6202A, 6202B, 6202C, 6202D, 6202E, and 6202F (obscured from view). Generally, the support elements are evenly distributed around the second elongate element 6300. In some instances, the support elements are formed in the wall of the second elongate element 6300. In some such instances, one or more slits or cut lines are formed in the wall of the second elongate element 6300. The slits or cut lines extend longitudinally along a portion of the second elongate element 6300. The support elements are formed between adjacent longitudinally extending slits. Generally, the slit extends from the outer surface of the second elongate element 6300 to the inner lumen.

[0128] In some instances, the support elements extend from a location proximal to the distal end 6302 of the second elongate element 6300 to a location proximal thereto, as shown. That is, each support element has a distal end, a proximal end, and an intermediate portion extending therebetween. In some instances, the length of a support element is measured between the distal and proximal ends of the support element. In some instances, the distal and proximal ends of the support element terminate within the second elongate element 6300, as described further below.

[0129] In some instances, a blood-permeable membrane 6204 (such as those described above) is disposed around the support element or a portion thereof. In some instances, the distal end of the blood-permeable membrane is disposed along an intermediate portion of the support element. In some instances, the proximal end of the blood-permeable membrane is disposed at or proximal to the proximal end of the support element. That is, in some instances, the blood-permeable membrane extends from a position along the support element proximal to the distal end of the support element to or proximal to the proximal end of the support element. In some instances, as described further below, the support element and blood-permeable membrane operate to filter embolic debris from the blood.

[0130] In some instances, the blood-permeable membrane is bonded or otherwise secured to the elongate element at or proximal to the proximal end of the support element. In some instances, the blood-permeable membrane is further bonded or otherwise secured to an intermediate portion of the support element, but this need not be the case. In some other instances, the blood-permeable membrane includes one or more tethers extending from the distal end of the blood-permeable membrane to a location along either the support element or a portion of the second elongate element 6300 distal thereto. For example, as shown in FIGS. 6A and 6B , the second elongate element 6300 includes a distal portion 6308 extending between the distal end 6302 of the elongate element and the distal end of the support element. In some instances, the support element terminates proximal to the distal portion 6308 such that the distal portion 6308 does not include a slit.

[0131] In some instances, the first elongate element 6100 and the second elongate element 6300 are fixed or otherwise coupled to one another at the distal portion 6308. In some instances, the first elongate element 6100 and the second elongate element 6300 are fixed or otherwise coupled together such that their distal ends are constrained against relative axial translation. In some such instances, the portions of the first elongate element 6100 and the second elongate element 6300 proximal to the distal portion 6308 are free to axially translate (or slide) relative to one another. As described further below, the filtering portion of the embolic filter system 6000 is deployed by sliding the proximal end 6304 of the second elongate element 6300 relative to the proximal end 6104 of the first elongate element 6100.

[0132] In various examples, the embolic filter system 6000 can be deployed within a region of a patient's vasculature, whereby the embolic filter system 6000 operates to filter embolic debris from blood flowing through that region. In some such examples, the embolic filter system 6000 is transitionable between a deployed configuration and a delivery configuration, as described in further detail below. Figure 6A illustrates the embolic filter system 6000 in the delivery configuration, while Figure 6B illustrates the embolic filter system 6000 in the deployed configuration. In various examples, the embolic filter system 6000 can be deployed within a region of a patient's vasculature, whereby the embolic filter system 6000 operates to filter embolic debris from blood flowing through that region. In some such examples, the embolic filter system 6000 can be transitioned between a deployed configuration and a delivery configuration, as described in further detail below. Figure 6A illustrates the embolic filter system 6000 in the delivery configuration, while Figure 6B illustrates the embolic filter system 6000 in the deployed configuration.

[0133] In some instances, in the delivery configuration, embolic filter system 6000 maintains a minimal delivery profile. However, upon transition to the deployed configuration, the filtering portion of embolic filter system 6000 expands to occupy some or all of the cross-sectional area of ​​the vessel in which it is deployed (similar to other embolic filter systems described herein). In some instances, in the deployed configuration, the support elements (6202A-6202F), or portions thereof, flex away from the longitudinal axis of second elongate element 6300.

[0134] In some instances, the embolic filter system 6000 is transitioned to the deployed configuration by axially translating or sliding the proximal end 6304 of the second elongate element 6300 in the distal direction relative to the proximal end 6104 of the first elongate element 6100. In some instances, the embolic filter system 6000 is transitioned to the deployed configuration additionally or alternatively by axially translating or sliding the proximal end 6104 of the first elongate element 6100 in the proximal direction relative to the proximal end 6304 of the second elongate element 6300. It will be appreciated that in some instances, the embolic filter system 6000 can similarly be deployed by proximally translating or sliding the proximal end 6104 of the first elongate element 6100 while maintaining a constant (or substantially constant) position of the proximal end 6304 of the second elongate element 6300. Similarly, in some examples, the embolic filter system 6000 can be deployed by translating or sliding the proximal end 6304 of the second elongate element 6300 distally while maintaining a constant (or substantially constant) position of the proximal end 6104 of the first elongate element 6100.

[0135] One skilled in the art will understand that because the first elongate element 6100 and the second elongate element 6300 are secured together at the distal portion 6308, one or more of the first elongate element 6100 and the second elongate element 6300 must buckle when the proximal end 6304 of the second elongate element 6300 translates distally relative to the proximal end 6104 of the first elongate element 6100. In this regard, the support elements of the second elongate element 6300 are configured to flex away from the longitudinal axis of the second elongate element 6300. For example, as shown in FIG. 6B , the support elements (6202A-6202F) bend, buckle, or otherwise flex as a result of the proximal end 6304 of the second elongate element 6300 translating distally relative to the proximal end 6104 of the first elongate element 6100.

[0136] This deflection of the support elements acts to expand blood-permeable membrane 6204 within the vessel in which embolic filter system 6000 is deployed. Although obscured from view in FIGURE 6B, in some instances, the portion of first elongate element 6100 extending below the support elements of second elongate element 6300 can include one or more apertures (similar to aperture 1112) that operate to allow embolic debris captured by the blood-permeable membrane to transition into lumen 6106 of first elongate element 6100 when embolic filter system 6000 transitions from the deployed configuration to the delivery configuration upon removal from the vasculature. In some instances, such apertures are located along first elongate element proximal to the location of the distal end of blood-permeable membrane 6204 when embolic filter system 6000 is in the deployed configuration. Such a configuration ensures that embolic debris escaping from the lumen 6106 is captured and retained by the blood permeable membrane 6204 .

[0137] In some other examples where there is no aperture in the portion of the first elongate element 6100 where the first elongate element extends below the support element of the second elongate element 6300, embolic debris captured by the blood-permeable membrane 6204 will be trapped between the blood-permeable membrane (and / or support element) and the outside of the portion of the first elongate element 6100 that extends below the support element of the second elongate element 6300, as will be understood by those skilled in the art.

[0138] In some instances, the embolic filter system 6000 is transitioned from the deployed configuration to the delivery configuration by axially translating or sliding the proximal end 6304 of the second elongate element 6300 in the proximal direction relative to the proximal end 6104 of the first elongate element 6100. In some instances, the embolic filter system 6000 is additionally or alternatively transitioned from the deployed configuration to the delivery configuration by axially translating or sliding the proximal end 6104 of the first elongate element 6100 in the distal direction relative to the proximal end 6304 of the second elongate element 6300. It will be appreciated that in some instances, the proximal end 6104 of the first elongate element 6100 can be axially translated in the proximal direction while maintaining a constant (or substantially constant) position of the proximal end 6304 of the second elongate element 6300. Similarly, in some examples, the proximal end 6304 of the second elongate element 6300 can be axially translated in the distal direction while maintaining a constant (or substantially constant) position of the proximal end 6104 of the first elongate element 6100.

[0139] While embolic filter system 6000 is shown and described as including six support elements (6202A-6202F), it should be understood that embolic filter system 6000 may include any number of support elements. Similarly, while the support elements are shown as being evenly distributed around second elongate element 6300, it should be understood that the support elements may be unevenly distributed. Similarly, the support elements need not all be the same size (length and / or width).

[0140] As described above, in some examples, the system can include one or more steering lines (or wires). Thus, in some examples, the system is steerable. In some examples, the one or more steering lines are coupled to the distal end of the elongate element. Referring to FIG. 1B , in some examples, the one or more steering lines can be coupled to the distal portion 1110 of the elongate element 1100, or alternatively or additionally, can be coupled to the distal end 1102 of the elongate element. Thus, in some examples, the one or more steering lines are coupled to the elongate element at a location distal to the proximal end of the filter (e.g., the proximal end 1204 of the filter 1200). Such a configuration improves the steerability or deflectability of the distal end of the system, which can help provide greater control when navigating tortuous regions of the vasculature and minimize the risk of vessel trauma.

[0141] In some instances, the elongate elements and / or deflectors can be housed within a sleeve, sheath, sock, or other restraining mechanism. Such restraining mechanisms (and / or the elongate elements and / or deflectors themselves) can have deployment lines that, when locked (e.g., pins, wires, or otherwise), act as tension lines (acting as steering lines), thereby bending the elongate elements and / or deflectors. In some such instances, the sleeve, sheath, sock, or other restraining mechanism in which the elongate elements are housed generally terminates proximal to the region where the steering lines (i.e., fixed deployment lines or tension lines) are coupled to the elongate elements. Such a configuration provides that, when tension is applied to the steering lines, the elongate elements and steering lines can form a bow-and-string configuration, thereby deflecting the distal end of the system. Those skilled in the art will appreciate that steerable embodiments can be particularly beneficial for treating the aortic arch or other tortuous vasculature. Steerable embodiments can be particularly useful in tortuous anatomies to prevent the deflector from compressing against the outside of a bend. Such steerable embodiments can also be useful to create an exit from the elongate element that is substantially aligned with the axis of the vessel and the axis of the deflector mechanism.

[0142] In some examples, embolic filter system 1000 includes one or more mechanisms that operate to assist in transitioning embolic filter system 1000 between the deployed configuration and the delivery / detachment configuration. While not identical, in some examples, such mechanisms may be implemented in addition to or in place of constraining elements 1300. For example, as shown in FIG. 7 , in some examples, embolic filter system 1000 includes one or more constraining elements, such as constraining fibers 1214. Constraining fibers 1214 are generally operable to control the expansion and / or collapse of filter 1200. In various examples, constraining fibers 1214 are routed around filter 1200, thereby decreasing and / or increasing the length of constraining fibers 1214 extending around filter 1200 to constrain or unconstrain filter 1200, thereby allowing the filter to transition between the collapsed and expanded states, as will be understood by those skilled in the art.

[0143] As shown in FIG. 7 , the constraining fibers 1214 are routed circumferentially around the outer surface of the filter 1200. However, it will be understood that the constraining fibers 1214 can alternatively be routed around the inner surface of the filter 1200 or routed transversely along one or more portions of both the inner and outer surfaces of the filter 1200. For example, in some instances, the filter 1200 can include a plurality of perforations arranged around the circumference of the filter 1200. In some such instances, the constraining fibers 1214 are routed through the various perforations such that the constraining fibers 1214 extend circumferentially around the filter 1200, as will be understood by those skilled in the art. The constraining fibers 1214 can extend around the outside of the structural support 1212 in any of the configurations described above. Alternatively, in some instances, the constraining fibers 1214 extend around the inside of the structural support 1212. Still further, in some instances, the constraining fibers 1214 can be routed to extend around one or more portions of both the interior and exterior of the structural support 1212 .

[0144] In some instances, the constraining fibers 1214 are routed through one or more features of the filter 1200 that define a designated path along and / or around the filter 1200. For example, as shown in FIG. 7 , the embolic filter system 1000 includes one or more routing conduits 1218 that extend along one or more portions of the embolic filter system 1000. In some instances, the one or more routing conduits 1218 extend along the interior and / or exterior of the constraining element 1300. In some instances, the one or more routing conduits 1218 extend along the interior and / or exterior of the filter 1200 consistent with the description above. In various instances, the constraining fibers 1214 are routed through and in sliding relationship with such routing conduits 1218. Thus, it will be understood that while the routing conduits 1218 generally constrain the routing paths of the constraining fibers 1214, the constraining fibers 1214 do not freely slide within (e.g., relative to) such routing conduits 1218. Although the routing conduits 1218 are shown in FIG. 7 as extending longitudinally along the filter 1200, in various examples, one or more routing conduits may extend (partially or entirely) circumferentially around the filter 1200.

[0145] In various examples, the constraining fibers 1214 extend longitudinally from the proximal end of the embolic filter system 1000, such as from the handle 1400 or other control mechanism as will be understood by one of ordinary skill in the art. As shown in FIG. 7 , the constraining fibers 1214 extend through an interior region of the embolic filter system 1000, through the aperture 1308, and along the outer surface of the filter 1200. In some examples, the constraining fibers 1214 extend through one or more portions of the inner lumen of the elongate element 1100. In some examples, the constraining fibers alternatively or additionally extend through one or more portions of the inner lumen of the constraining element 1300. Thus, in some examples, the constraining fibers 1214 extend within an annular region defined between the constraining element 1300 and the elongate element 1100. Furthermore, although the restraining fiber 1214 is shown extending through the aperture 1308 of the restraining element 1300, in some examples the restraining fiber 1214 extends from the distal end 1302 of the restraining element 1300 (or from the distal end 1102 of the elongate element 1100).

[0146] In various examples, as will be appreciated by those skilled in the art, the constraining fiber 1214 forms a loop around the filter 1200, thereby allowing the diameter of the loop to contract or expand to constrain and / or unconstrain the filter 1200. In some examples, the distal end of the constraining fiber 1214 includes an eyelet 1216 or other mechanism that facilitates entangling the constraining fiber 1214 upon itself, such that the tension applied to the constraining fiber 1214 can be varied, resulting in a variation in the diameter of the loop. In some examples, the constraining fiber 1214 can be used in combination with a locking wire. For example, in some examples, a portion of the constraining fiber 1214, such as the distal end eyelet, is constrained by engagement with a locking wire. Such engagement with a locking wire allows tension to be applied and removed from the constraining fiber 1214 without removing the constraining fiber 1214 from its position around the filter 1200. In some such instances, the constraining fiber 1214 extends around the filter 1200, entangles itself, and extends to a position where it engages the lock wire. In some instances, upon removal of the lock wire, the constraining fiber 1214 can be detached from the lock wire and removed from around the filter 1200.

[0147] As discussed above, in some instances, the elongate element 2100 lacks sufficient structural rigidity to support its own weight, has little or no column strength, and / or is generally not torqueable, yet still exhibits good tensile strength. In some other instances, the elongate element 2100 may include one or more structural elements or components that provide sufficient structural integrity so that the elongate element 2100 is advanceable within an introducer sheath and / or a constraining element, such as the constraining element 2400. That is, in some instances, the elongate element includes both structural elements and a covering material. The structural elements and covering materials are consistent with those discussed herein. By providing the elongate element 2100 with structural elements, the elongate element 2100 can be introduced into the vasculature without the need for an additional introducer. In particular, the structural elements of the elongate element 2100 in combination with the covering material provide a construct that can be advanced (e.g., pushed) within an introducer sheath and / or a constraining sheath. That is, applying a distal force to the proximal end of elongate element 2100 will act to translate elongate element 2100 (and filter 2200) distally, even when embolic filter system 2000 is not attached to an introducer.

[0148] In some instances, such a configuration provides a system with a smaller delivery profile compared to conventional designs because, in some instances, the elongate element 2100 can be radially collapsed on itself instead of being compressed onto an introducer or delivery catheter, as will be appreciated by those skilled in the art. Similarly, by being pushable within an introducer sheath and / or a constraining sheath, the elongate element 2100 does not require additional components for delivery, which reduces system costs, procedure time, and risk to the patient.

[0149] Referring to FIG. 8 , in some such examples, the embolic filter system 2000 includes an elongate element 2100 having a structural element, such as a braided element. In some examples, the braided element includes nitinol wire, although other materials, including those discussed herein, are contemplated. In some examples, the braided element is coated with a suitable coating material (e.g., a filter material), such as ePTFE or any other suitable material discussed herein, to form the elongate element 2100. In some examples, the coating material of the elongate element 2100 is blood permeable. In other examples, the coating material of the elongate element 2100 is blood impermeable. In some examples, the blood-impermeable coating material of the elongate element is modified, consistent with the discussion herein, to allow blood to flow through the perforations. In some such examples, the perforations are sized to prevent the passage of embolic debris above a specified threshold size. For example, as discussed herein, the perforations can be between 50 microns and 1000 microns depending on the particular application. As one skilled in the art will understand, it will also be understood that the elongate member may be configured to be operable to allow blood to pass or flow through one or more portions of the elongate member 2100 while preventing blood from flowing through one or more other portions of the elongate member 2100.

[0150] Further, as shown in FIG. 8 , embolic filter system 2000 includes filter 2200. Filter 2200 generally includes a braided structural support 2212 and a covering material, consistent with the discussion above. In some instances, the covering material of filter 2200 is the same as the covering material of elongate element 2100. In some instances, the structural support of filter 2200 is the same as the structural support of the elongate element. In some instances, the covering material of filter 2200 is blood permeable. In other instances, the covering material of filter 2200 is blood impermeable. In some instances, the blood impermeable covering material of filter 2200 is modified, consistent with the discussion herein, to operatively allow blood to flow through the perforations. In some such instances, the perforations are sized to prevent the passage of embolic debris above a specified threshold size as discussed herein. As one skilled in the art will appreciate, it will also be understood that the elongate member may be configured to be operable to allow blood to pass or flow through one or more portions of filter 2200 while preventing blood from flowing through one or more other portions of filter 2200.

[0151] Numerous features and advantages, including various alternatives along with details of the structure and function of the device and / or method, have been set forth in the foregoing description. Moreover, the inventive scope of the various concepts addressed in this disclosure has been described both generally and with reference to specific examples. This disclosure is intended to be illustrative only and, therefore, not exhaustive. For example, while various embodiments of the present disclosure have been described in connection with medical applications, they may also be useful in non-medical applications. It will be apparent to those skilled in the art that various changes may be made, particularly with respect to structure, materials, elements, components, shapes, sizes, and arrangements of parts, including combinations within the principles of the present invention, to the full extent indicated by the broad and general meaning of the terms in which the appended claims are expressed. To the extent that these changes do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein. (Aspect) (Aspect 1) an elongate element having a proximal end and a distal end; a filter portion disposed at a distal end of the elongate element; 1. An embolic filter comprising: wherein the elongate element comprises a first structural element and a first covering material, the elongate element having sufficient structural integrity to support being advanced within a delivery sheath; and the filter portion includes a second structural element and a second coating material, a portion of the second coating material including a plurality of perforations configured to filter embolic debris from blood entering the filter portion. Embolic filters. (Aspect 2) The embolic filter of embodiment 1, wherein the first structural element is a self-expanding wire braid. (Aspect 3) The embolic filter of any one of embodiments 1 to 2, wherein a distal force applied to the proximal end of the elongate element is operable to cause distal translation of the elongate element and filter portion relative to the delivery sheath. (Aspect 4) The embolic filter of any one of embodiments 1-3, wherein the elongate element has sufficient structural integrity to support being advanced within a delivery sheath without the need for an introducer. (Aspect 5) The embolic filter of any one of embodiments 1-4, wherein said filter portion is blood permeable and said plurality of perforations has an average size of 100 microns. (Aspect 6) 6. The embolic filter of any one of embodiments 1-5, wherein the second coating material of the filter portion is blood impermeable and comprises a plurality of perforations formed therein such that blood can operatively flow through the second coating material of the filter portion. (Aspect 7) The embolic filter of any one of embodiments 1-6, wherein said elongate element is blood impermeable. (Aspect 8) The embolic filter of any one of embodiments 1-7, wherein the elongate element is configured to be advanced through a valve that operates to control blood flow through the lumen of the elongate element during a clinical procedure. (Aspect 9) The embolic filter of any one of embodiments 1-8, wherein one of the first and second coating materials comprises ePTFE. (Aspect 10) a filter assembly having two end portions and an elongated intermediate portion; and a structural element; wherein at a first end, the filter assembly includes an expandable filter element having an expandable frame and a filter material; The intermediate section comprises a thin, unsupported polymeric material configured to be mounted onto a structural element for advancement within a catheter lumen for delivery to a treatment site, and configured to remain at the treatment site while the structural element is removed. (Aspect 11) 11. The embolic filter of embodiment 10, wherein the structural element is configured to advance the first end of the filter assembly out of the end of a catheter for deployment at a treatment site. (Aspect 12) The intermediate section includes a valve operable to control blood flow through the lumen of the intermediate section during a clinical procedure. 12. The embolic filter of any one of embodiments 10-11, wherein the filter is configured to be advanced through a (Aspect 13) 13. The embolic filter of claim 12, wherein the lumen of the intermediate section is configured to accommodate advancement of one or more medical devices therethrough during a clinical procedure, and the valve is configured to control blood flow through the lumen of the intermediate section during a clinical procedure. (Aspect 14) 14. The embolic filter of any one of embodiments 10-13, wherein said filter material is blood permeable and comprises a plurality of perforations having an average size of 100 microns. (Aspect 15) The embolic filter of any one of embodiments 10 to 14, wherein the polymeric material of said intermediate portion is blood impermeable. (Aspect 16) 16. The embolic filter of any one of embodiments 10-15, wherein one of the filter material and the polymeric material comprises ePTFE. (Aspect 17) an expandable filter element mounted on a catheter shaft, the expandable filter element having a capture region within the expandable filter element when the expandable filter element is deployed; an elongate conduit configured to extend through and beyond the expandable filter element when the expandable filter element is deployed at a treatment site; Including, wherein the conduit is configured to allow delivery of an endogenous protease across the expandable filter element; the elongate conduit includes at least one aperture through a sidewall that provides fluid communication between the capture region and the interior of the elongate conduit; An endoprosthesis delivery device. (Aspect 18) 18. The device of embodiment 17, wherein the elongate conduit extends from the catheter shaft. (Aspect 19) 19. The device of any one of embodiments 17-18, wherein the elongate conduit and catheter shaft form a single monolithic unit. (Aspect 20) 20. The device of any one of embodiments 17-19, wherein the at least one aperture is configured to facilitate movement of embolic debris trapped within the filter into the elongate conduit.

Claims

1. an elongate element having a proximal end and a distal end and a lumen extending therethrough; a filter portion coupled to the distal end of the elongate element; 1. An embolic filter system comprising: wherein the elongate element includes a first structural support and a first membrane disposed entirely around the first structural support, the elongate element having sufficient structural integrity to support being advanced within a delivery sheath; and the filter portion includes a second structural support and a second membrane disposed entirely around the second structural support, a portion of the second membrane including a plurality of perforations configured to filter embolic debris from blood entering the filter portion; the distal end of the elongate element is defined by the first structural support; the filter portion is constituted by the second structural support and the second membrane, the filter portion may be continuously bonded to the second structural support, while the first membrane may be continuously bonded to the second membrane; The material and / or permeability of the first membrane and the material and / or permeability of the second membrane are the same, respectively; Embolic filter system.

2. The embolic filter system of claim 1 , wherein said elongate element is a self-expanding wire braid, said filter portion is blood permeable, and said plurality of perforations have an average size of 100 microns.

3. 3. The embolic filter system of claim 1, wherein the elongate element is blood impermeable and the second membrane of the filter portion is blood impermeable and includes a plurality of perforations formed therein operable to allow blood to flow through the second membrane of the filter portion.

4. 4. The embolic filter system of claim 1, wherein the filter portion has a distal end and a proximal end, both of which are open to facilitate blood flow into the filter portion at the distal end and out of the filter portion at the proximal end.

5. The embolic filter system of any one of claims 1 to 4, wherein the material and / or permeability of the first structural support and the material and / or permeability of the second structural support are the same, respectively.

6. The embolic filter system of any one of claims 1 to 5, wherein the elongate element includes a stop mechanism integral to the elongate element and disposed at the proximal end of the elongate element that controls how far the elongate element can be advanced through the vasculature.

7. The embolic filter system of claim 6 , wherein the stop mechanism facilitates capturing and withdrawing the elongate element and the filter portion from the vasculature.

8. The embolic filter system of any one of claims 1 to 7, wherein a distal force applied to the proximal end of the elongate element is operable to cause distal translation of the elongate element and the filter portion relative to the delivery sheath.

9. The embolic filter system of any one of claims 1 to 8, wherein the elongate element includes a valve operable to control blood flow through the lumen of the elongate element during a clinical procedure.

10. The embolic filter system of any one of claims 1 to 9, wherein the first membrane and the second membrane comprise ePTFE.

11. An embolic filter system as described in any one of claims 1 to 10, further comprising a restraining fiber routed around the inside or outside of the second structural support of the filter portion and configured to control the expansion or folding of the filter portion.

12. An embolic filter system as described in claim 11, wherein the elongate element includes an inner lumen extending between the proximal end and the distal end, and the restraining fiber extends at least partially through the inner lumen of the elongate element.

13. An embolic filter system as described in claim 11 or 12, wherein the distal end of the restraining fiber includes an eyelet that facilitates entangling the restraining fiber upon itself so as to vary the tension applied to the restraining fiber, causing variation in the diameter of the loop formed by the restraining fiber and thereby controlling the expansion or collapse of the filter portion.

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