Embolic Protection System

Abstract

An embolic protection system for delivering, deploying, and retrieving a filter configured to capture particles that may become dislodged during a medical procedure. The embolic protection system may include an embolic protection device that captures the particles, a delivery catheter assembly for delivering the embolic protection device to a target location within the vasculature, and a retrieval catheter assembly for retrieving the embolic protection device, along with the captured particles, from the target location after use. The embolic protection device includes a filter movably connected to a guidewire, such that after deployment, the filter can move both axially and rotationally relative to the guidewire, thereby reducing the risk of vasospasm or vascular dissection.

Description

[Technical Field]

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 476,533, filed December 21, 2022, entitled "Embolic Protection System," which is incorporated herein by reference in its entirety. [Background technology]

[0002] During certain medical procedures, such as, but not limited to, carotid stenting, embolic particles may be dislodged by a physician's surgical instruments. Typical examples of such embolic particles include thrombus, atheroma, and lipids, which, once dislodged, may cause blockages in downstream blood vessels. These embolic particles may therefore result in serious complications, including stroke and even death.

[0003] One way to reduce the risk of such complications is to capture any particles that may become dislodged by placing an embolic protection device, such as a filter, downstream from the surgical site. Once captured, the filter can be closed and removed from the patient to prevent trapped embolic particles from escaping.

[0004] Such filters may desirably be adjustable in one or more ways to reduce the risk of various undesirable conditions such as vasospasm, vascular dissection, etc. Such filters may also desirably include an integral guidewire to eliminate the need for a separate guidewire during the procedure, a radiopaque wire to improve visibility, and an anticoagulant surface treatment to reduce clot formation. Summary of the Invention

[0005] Disclosed herein is an embolic protection system that can be delivered to a target site within a patient, deployed to capture detached particles, and retrieved from the patient.

[0006] In one example embodiment, the embolic protection system may include an embolic protection device that captures the detached particles, a delivery catheter assembly for delivering the embolic protection device, and a retrieval catheter assembly for retrieving the embolic protection device containing the captured particles.

[0007] In one example embodiment, the embolic protection device may comprise a braided mesh and / or a filter having one or more structural wires.

[0008] In one example embodiment, the embolic protection device may include one or more clamps that connect the embolic protection device to an elongate member, such as a guidewire.

[0009] In one example embodiment, one or more of the clamps may be movably connected to the guidewire.

[0010] In one example embodiment, a tubular member, such as an elongated cylindrical member, may extend distally from the distal clamp of the embolic protection device for improved visualization.

[0011] In one example embodiment, the tubular member may have a durometer that varies along its length.

[0012] In one example embodiment, a first portion of the tubular member may have a first durometer hardness and a second portion of the tubular member may have a second durometer hardness.

[0013] In one example embodiment, the proximal portion of the tubular member may have a durometer that is greater than the durometer of the distal portion of the tubular member.

[0014] In one example embodiment, a proximal portion of the tubular member may comprise a first material and a distal portion of the tubular member may comprise a second material.

[0015] In one example embodiment, the first material may include PEBAX 53D and the second material may include PEBAX 35D.

[0016] In one example embodiment, the filter may be adjustable between a radially contracted state and a radially expanded state.

[0017] In one example embodiment, the filter may have a conical shape when in a radially expanded state.

[0018] In one example embodiment, the filter may be connected to one or more clamps for movement relative to the inner elongate member when the filter is in a radially expanded state.

[0019] In one example embodiment, the filter may be connected to the elongate member by a pair of clamps including a first clamp connected to a proximal end of the filter and a second clamp connected to a distal end of the filter.

[0020] In one example embodiment, the filter is capable of axial movement relative to the elongate member when the filter is in the radially expanded state.

[0021] In one example embodiment, the filter is capable of rotational movement relative to the elongate member when the filter is in the radially expanded state.

[0022] In one example embodiment, the filter is movable both rotationally and axially relative to the elongate member when the filter is in the radially expanded state.

[0023] In one example embodiment, the filter may comprise multiple wire pairs.

[0024] In one example embodiment, the filter may comprise a braided mesh and one or more structural wires. The one or more structural wires may include one or more stretch-filled tubing (DFT) wires. The structural wires may comprise two pairs of wires, such that one or more pairs of wires form at least a portion of the filter.

[0025] In one example embodiment, a stopper may be connected to the elongate member to limit movement of the filter relative to the elongate member. The stopper may function to limit axial translation of the filter. The stopper may also or alternatively function to interconnect multiple sections of the elongate member.

[0026] In one example embodiment, the filter (eg, structural wire and / or braided mesh) may be provided with an anticoagulant surface treatment to help prevent blood clot formation during use.

[0027] In one example embodiment, a radiopaque band, wire, or coil may be placed around the distal end or distal portion of the elongate member to improve visibility of the distal end of the elongate member during use.

[0028] In one example embodiment, the structural wire or wires may extend the entire length of the filter, and the mesh braid may extend along only about 40% to 60% of the entire length of the filter.

[0029] In one example embodiment, the embolic protection system may include a delivery catheter assembly having a guidewire, a filter assembly having a filter movably connected to the guidewire, a housing for receiving the filter assembly prior to deployment, and a release wire connected to the housing for retracting the housing from around the filter.

[0030] In one example embodiment, a placement handle may be connected to the release wire to allow for one-handed operation to push or pull the release wire.

[0031] In one example embodiment, the deployment handle may include a trigger movably or slidably connected within a slot such that pulling the trigger proximally retracts the release wire, thereby deploying the filter of the embolic protection device.

[0032] In one example embodiment, the deployment handle may include a locking mechanism that locks the trigger in a non-deployed state, thereby preventing premature deployment of the embolic protection device.

[0033] In one example embodiment, the housing may include at least one marker band, which may be located at or near the distal end of the housing.

[0034] In one example embodiment, the embolic protection system may further comprise a retrieval catheter assembly for retrieving the embolic protection device along with any trapped particles it contains after use.

[0035] In one example embodiment, the retrieval catheter assembly may include one or more marker bands to visualize when the filter is fully seated within the retrieval catheter assembly.

[0036] In one example embodiment, the distal port of the retrieval catheter may have an inwardly sloping surface or an inwardly tapered distal end to prevent fraying of the filter as it enters the distal port of the retrieval catheter.

[0037] In one example embodiment, an adjustment handle may be connected to the retrieval catheter to selectively deflect or adjust the distal end of the retrieval catheter to improve maneuverability when positioning the retrieval catheter to retrieve the filter.

[0038] In one exemplary embodiment, the recovery catheter may be flushed with fluid in its original packaging by filling a syringe with fluid (e.g., saline), fluidly connecting the syringe to the recovery catheter (e.g., using flexible tubing), and expelling the fluid from the syringe to flush the recovery catheter with the fluid. [Brief explanation of the drawings]

[0039] The following drawings are presented to illustrate certain aspects of the invention and should not be considered exclusive embodiments. The disclosed subject matter is susceptible to numerous variations, modifications, combinations, and equivalents in form and function, as will occur to those skilled in the art and which will have the benefit of the invention. These and other aspects, features, and advantages, as made possible by the practice of the invention, will become apparent and elucidated from the following description of embodiments of the invention, which proceeds with reference to the accompanying drawings.

[0040] [Figure 1] FIG. 1 illustrates an embolic protection device in a radially expanded state, according to an exemplary embodiment of the present invention.

[0041] [Figure 2] FIG. 2 illustrates a side view of an embolic protection system in a radially contracted state, according to an example embodiment of the present invention.

[0042] [Figure 3] FIG. 3 illustrates a side view of an embolic protection device of an embolic protection system in a radially expanded state, including a filter movably connected to an elongate member, such as a guidewire, according to an exemplary embodiment of the present invention.

[0043] [Figure 4] FIG. 4 illustrates a first perspective view of a filter for use in an embolic protection device in an expanded state, according to an example embodiment of the present invention.

[0044] [Figure 5]FIG. 5 illustrates a second perspective view of a filter for use in an embolic protection device in an expanded state, according to an example embodiment of the present invention.

[0045] [Figure 6] FIG. 6 illustrates a side view of a delivery catheter of an embolic protection system with interconnected pull and push assemblies, according to an example embodiment of the present invention.

[0046] [Figure 7] FIG. 7 illustrates a side view of a pull assembly of a delivery catheter of an embolic protection system, according to an example embodiment of the present invention.

[0047] [Figure 8] FIG. 8 illustrates a side view of a push assembly of a delivery catheter of an embolic protection system, according to an example embodiment of the present invention.

[0048] [Figure 9] FIG. 9 illustrates a side view of a retrieval catheter of an embolic protection system that can be used to retrieve an embolic protection device, according to an example embodiment of the present invention.

[0049] [Figure 10] FIG. 10 shows an expanded view of the frame and braid of an embolic protection device, according to an example embodiment of the present invention.

[0050] [Figure 11] FIG. 11 illustrates a side view of another example embolic protection device of an embolic protection system, according to an example embodiment of the present invention.

[0051] [Figure 12A] FIG. 12A illustrates a top perspective view of a deployment handle of an embolic protection system in an undeployed state, according to an example embodiment of the present invention.

[0052] [Figure 12B]FIG. 12B illustrates a top perspective view of the deployment handle of the embolic protection system in a deployed state, according to an example embodiment of the present invention.

[0053] [Figure 12C] FIG. 12C illustrates a side view of the deployment handle of the embolic protection system in an unlocked state, according to an example embodiment of the present invention.

[0054] [Figure 12D] FIG. 12D illustrates a top view of the deployment handle of the embolic protection system in a locked state, according to an example embodiment of the present invention.

[0055] [Figure 13A] FIG. 13A illustrates a perspective view of a retrieval catheter positioned to retrieve an embolic protection device of an embolic protection system, according to an exemplary embodiment of the present invention.

[0056] [Figure 13B] FIG. 13B illustrates a perspective view of an embolic protection device being retrieved by a retrieval catheter of an embolic protection system, according to an example embodiment of the present invention.

[0057] [Figure 14] FIG. 14 illustrates a side view of an adjustment handle for use with a retrieval catheter of an embolic protection system, according to an exemplary embodiment of the present invention.

[0058] [Figure 15] FIG. 15 illustrates a side view of a flushing system for flushing a retrieval catheter of an embolic protection system, according to an example embodiment of the present invention.

[0059] [Figure 16A] FIG. 16A illustrates the proximal region of a multi-lumen delivery catheter according to one embodiment of the present invention.

[0060] [Figure 16B]FIG. 16B illustrates cross section BB of the delivery catheter of FIG. 16A, according to an example embodiment of the invention.

[0061] [Figure 16C] FIG. 16C illustrates cross section CC of the delivery catheter of FIG. 16A, according to an example embodiment of the invention.

[0062] [Figure 17] FIG. 17 illustrates an exemplary distal end of a guidewire of an embolic protection device, according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0063] Specific embodiments of the present invention will be described below with reference to the drawings. However, the present invention can be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the accompanying drawings is not intended to be limiting of the present invention. In the drawings, like numbers refer to like elements.

[0064] In the terminology described below, the terms "clot," "thrombus," "embolus," and "occlusion" may be used interchangeably.

[0065] As used herein, the use of the terms "about," "per," or "approximately" when referring to a value may be understood to mean within 5% of the stated value (either greater than or less than that value), inclusive.

[0066] Disclosed herein are exemplary embodiments of embolic protection systems that may include, for example, an embolic protection device for capturing detached embolic particles, a delivery catheter assembly for delivering the embolic protection device, and a retrieval catheter assembly for retrieving the embolic protection device containing the captured particles.

[0067] The embolic protection device may be placed within the vascular system, such as the carotid artery, distal to a location where a medical procedure known to have the potential to dislodge one or more particles is being performed, such as a stent placement or an angioplasty procedure. If one or more particles dislodge during the procedure, the embolic protection device can capture such dislodged particles and safely remove them from the body.

[0068] The embolic protection device may include an elongate member, such as an integrated guidewire, to which the filter may be movably connected. The elongate member may extend completely through the filter and extend both distally and proximally from the filter. The elongate member may be composed of two or more separate sections interconnected. For example, the elongate member may include a proximal guidewire and a distal guidewire.

[0069] The distal section of the elongate member may include a radiopaque marker to facilitate tracking during manipulation of the elongate member to a target location within the body. The radiopaque marker may include a radiopaque material known to be visible by various imaging devices. The radiopaque marker may comprise a band or coil secured to a distal portion of the elongate member, such as the distal tip, by various methods known in the art, such as welding.

[0070] The filter may include a frame. The frame may include one or more structural wires woven, braided, or coiled to form a substantially conical structure having an internal cavity. At least a portion of the one or more structural wires may be connected to a braid, such as a mesh braid, to capture broken-off particles. For example, the distal half of the filter may include a braid to capture debris, while the proximal half of the filter may not include a braid or may instead include only one or more structural wires to allow broken-off particles to enter and be captured within the internal cavity of the filter.

[0071] The filter may be movably connected to the elongate member. For example, the filter may be axially movable along the elongate member and / or rotationally movable relative to the elongate member. Such movement of the frame relative to the elongate member may reduce the likelihood of vasospasm or dissection occurring when manipulating the elongate member, such as during filter deployment.

[0072] The filter may be connected to the elongate member by one or more clamps. For example, the filter may be connected to the elongate member with a first clamp at a proximal end of the filter and a second clamp at a distal end of the filter. The filter may be fixedly attached to the clamps. One or more of the clamps may be movably connected to the elongate member and may slide axially and / or rotate relative to the elongate member, thereby allowing similar movement by the filter.

[0073] The filter may be adjustable between at least two states. For example, the filter may be adjustable between a radially contracted state and a radially expanded state. In the radially contracted state, the filter may contract to fit within a tubular housing, such as within a delivery catheter. In the radially expanded state, the filter may expand to form a substantially conical shape with a partially exposed internal cavity for capturing detached particles.

[0074] The distal tube tip may be connected to a clamp located at or near the distal end of the filter. The distal tube tip may be disposed over or at least partially around the elongate member. The distal tube tip may be constructed of a radiopaque material to facilitate visualization and tracking of the filter distal end with various imaging devices.

[0075] A stopper may be connected to the elongate member distal to a clamp located at or near the proximal end of the filter. The stopper may function to limit axial translation of the filter. The stopper may also serve to connect different sections of the elongate member, such as connecting a distal guidewire and a proximal guidewire that together form the elongate member.

[0076] The delivery catheter assembly may be used to deliver and deploy an embolic protection device at a target location during a medical procedure. The delivery catheter assembly may be advanced to the target location, such as a location within a carotid artery, with the embolic protection device disposed therein. The housing of the delivery catheter assembly may then be retracted by pulling a release wire, thereby allowing the embolic protection device to expand within the target vessel.

[0077] To achieve release wire deployment, the delivery catheter assembly may include a pair of subassemblies that are axially movable independently of one another. For example, the delivery catheter assembly may include a pull subassembly and a push subassembly that are connected to form a single delivery catheter assembly.

[0078] The pull subassembly may include a housing, a marker band, a distal shaft, and a release wire. The housing may include a tubular member within which the embolic protection device is placed prior to deployment. The marker band may be constructed of a radiopaque material to indicate when the embolic protection device is fully seated within the housing. The distal shaft may include a cylindrical member (solid or tubular) connecting the housing to the release wire. The release wire may include an elongated wire capable of retracting the housing when pulled.

[0079] The push subassembly may include a guidewire lumen, a cover tube, and a hypotube. The guidewire lumen may function as a hard stop for the embolic protection device when within the housing. The guidewire lumen may also function to push the filter out of the housing when the housing is retracted. The cover tube may cover the main interface between the push assembly and the pull assembly. The hypotube may house a release wire.

[0080] The retrieval catheter assembly may be used to retrieve the embolic protection device along with any trapped particles after use. The retrieval catheter assembly may be advanced to the embolic protection device, causing the embolic protection device to be retracted into the retrieval catheter assembly. Both the retrieval catheter assembly and the embolic protection device may then be removed from the body together.

[0081] The retrieval catheter assembly may include a distal port, a housing and cover tube, one or more marker bands, and a proximal shaft. The distal port may include a circular opening with a larger inner diameter than the housing to minimize or avoid fraying of the filter braid during retrieval. The housing and cover tube may include tubular members capable of receiving a collapsed embolic protection device during retrieval. The one or more marker bands may be attached to various locations on the housing and cover tube to aid in visualizing that the embolic protection device is fully seated within the housing. The proximal shaft may serve to connect the housing to a structural wire that forms the remainder of the length of the retrieval catheter assembly.

[0082] Examples of specific embodiments are further described below, however, it should be understood that any features of any of the embodiments may be mixed and matched with one another in any combination, and therefore the present invention should not be limited to only these embodiments, but also includes any broader combinations thereof.

[0083] 1-2 illustrate an exemplary embodiment of an embolic protection system 100 that includes an embolic protection device 110. As shown in FIG.

[0084] FIG. 1 illustrates embolic protection device 110 in a radially expanded state. In the radially expanded state, filter 111 may expand radially to the expanded state. In some embodiments, the radially expanded state may be used when deploying filter 111 for use in capturing loose particles. In the illustrated example embodiment, the expanded state may comprise a substantially conical shape. However, it should be understood that other shapes may be used. Furthermore, as described below, it should be understood that, in response to axial and / or rotational movement of filter 111, the overall shape of filter 111 may change during use to accommodate different situations, vessels, locations, etc.

[0085] FIG. 2 shows a side view of embolic protection device 110 in a radially contracted state. In some embodiments, in the radially contracted state, filter 111 can be radially contracted to a substantially linear or tubular shape, as shown. In such a radially contracted state, filter 111 can be sized and shaped to fit within a tubular housing 132 of a catheter. The radially contracted state can be employed during delivery and / or retrieval of filter 111 to a target location within a patient. For example, the radially contracted state can be employed to store filter 111 within delivery catheter 130 for delivery to the target location, and then, after use, to store filter 111 within retrieval catheter 140 (not shown) for retrieval from the target location along with any removed particles that have been captured.

[0086] 1-2, in some embodiments, the embolic protection device 110 may comprise an elongate member, such as a guidewire 120. Although the term "guidewire" is used herein in reference to an elongate member, it should be understood that various other types of elongate members may be used in connection with the embolic protection device 110.

[0087] In some embodiments, the guidewire 120 may be integrated with the embolic protection device 110, thereby facilitating use of the embolic protection system 100 during a medical procedure. Traditionally, embolic shields and the like have required a separate guidewire to be advanced to a target location within a patient. Instead, by incorporating an integrated guidewire 120, as shown in FIG. 1 , example embodiments may eliminate the need for such an additional device, thereby increasing the efficiency of use of the embolic protection system 100.

[0088] 1-2, guidewire 120 may comprise a proximal section 121 extending proximally outward from filter 111 and a distal section 122 extending distally outward from filter 111. In several example embodiments described below, proximal section 121 and distal section 122 may comprise separate elongated members connected to one another to form a single, integrated guidewire 120. The respective lengths of proximal section 121 and distal section 122 relative to the overall length of guidewire 120 may vary in various embodiments and, therefore, should not be construed as limited by the example embodiments shown.

[0089] In some embodiments, to aid in visualization, the distal section 122 may include a marker 123 constructed from a radiopaque material. The marker 123 may have a variety of configurations, including, for example, a wire wrapped around at least a portion of the distal section 122. The type of radiopaque material forming such a marker 123 may vary, including, for example, platinum. In this manner, the distal end 122 of the guidewire 120 may be visualized by various imaging devices known to those skilled in the art, thereby assisting in tracking the guidewire 120 as it is manipulated to a target location within the patient's body. In some embodiments, the proximal section 121 may alternatively or additionally include a marker 123 constructed from a radiopaque material.

[0090] 1-2, it can be seen that marker 123 may comprise a wire wound around proximal section 121 of guidewire 120 to form a coiled marker. However, various other configurations may be used in different embodiments. For example, marker 123 may instead comprise radially arranged marker bands around proximal section 121 and / or distal section 122 of guidewire 120. As yet another example, proximal section 121 and / or distal section 122 of guidewire 120 itself may be at least partially formed from a radiopaque material.

[0091] Figure 3 is a side view of an example embodiment of an embolic protection device 110 in a radially expanded state, including a filter 111 movably connected to an elongate member, such as a guidewire 120. As indicated by directional arrow D1, the filter 111 may be adjustably movable along a longitudinal axis, such that the filter 111 is axially movable relative to the guidewire 120 disposed therein. Alternatively, or in addition, the filter 111 may be adjustably movable rotationally about the longitudinal axis, such that the filter 111 is rotatable relative to the guidewire 120 disposed therein. While Figure 3 shows the filter 111 exhibiting both axial and rotational movement, it should be understood that in some embodiments, the filter 111 may be movable only axially or rotationally, rather than both.

[0092] The manner in which filter 111 is movably connected to guidewire 120 may vary in various embodiments. In the example embodiment shown in Figure 3, filter 111 is seen to be directly attached to a pair of clamps 115A, 115B, one or both of which are movably (rotationally and / or axially) connected to guidewire 120. In some embodiments, clamps 115A, 115B may comprise various types of connecting members and therefore should not be construed as limited in scope to cylindrical, capped tubular members as shown in the example embodiment of the drawings.

[0093] In the exemplary embodiment shown in Figures 3-5, a first clamp 115A may be connected to the proximal end of filter 111, and a second clamp 115B may be connected to the distal end of filter 111. In some embodiments, clamps 115A and 115B may each include an internal opening through which guidewire 120 extends. In some embodiments, each of clamps 115A and 115B may be freely axially movable toward or away from each other along the longitudinal axis. Additionally or alternatively, in some embodiments, each of clamps 115A and 115B may be freely rotatable about guidewire 120.

[0094] As best shown in FIG. 3 , in some embodiments, filter stopper 116 may be connected to guidewire 120 between proximal clamp 115A and distal clamp 115B. In some embodiments, filter stopper 116 may comprise a tubular member secured to guidewire 120 between clamps 115A and 115B. Filter stopper 116 may be used to set a minimum distance between clamps 115A and 115B to limit axial movement of filter 111 along guidewire 120 within a set range. Thus, filter stopper 116 may function to prevent clamps 115A and 115B from converging, thereby setting a minimum length to which filter 111 may axially retract.

[0095] The example embodiment of Figure 3 illustrates that the length of filter stopper 116 may be greater than half the overall length of filter 111. However, it should be understood that the length of filter stopper 116 may vary in various embodiments and, therefore, should not be construed as limited by the example embodiment shown. For example, filter stopper 116 may be longer or shorter than shown. Furthermore, while the illustration illustrates that filter stopper 116 may be primarily disposed inside the mesh portion of filter 111, different embodiments may use alternative configurations.

[0096] Continuing with reference to FIG. 3, in some embodiments, tubular member 117 may be positioned over at least a portion of guidewire 120 to increase stiffness and create a transition from the higher stiffness segment of filter 111 to the lower stiffness segment of guidewire 120. Tubular member 117 may at least partially cover, be adjacent to, and / or be attached to distal clamp 115B, such that tubular member 117 covers at least a portion of distal portion 122 of guidewire 121, as shown in FIG. 3. However, in some embodiments, tubular member 117 may alternatively or additionally be positioned over or adjacent proximal clamp 115A.

[0097] While FIG. 3 illustrates an example embodiment in which tubular member 117 is disposed around guidewire 120 and adjacent distal clamp 115B, as noted above, in some examples, tubular member 117 may additionally or alternatively be disposed around guidewire 120 and adjacent proximal clamp 115A. In some embodiments, tubular member 117 may be attached directly to proximal clamp 115A and / or distal clamp 115B. In other embodiments, tubular member 117 may be attached directly to guidewire 120 adjacent proximal clamp 115A and / or distal clamp 115B. Tubular member 117 may be constructed from a variety of materials, including, but not limited to, polymeric materials such as polyether block amide (PEBAX) or thermoplastic elastomers. The length of tubular member 117 may vary in various embodiments and, therefore, should not be construed as limited by the example embodiment shown.

[0098] Figures 4-5 show an example embodiment of a filter 111 for use with embolic protection device 110. Figure 4 shows a first perspective view of filter 111 for use with embolic protection device 110 in an expanded state. Figure 5 shows a second perspective view of the filter for use with the embolic protection device in an expanded state.

[0099] 4-5 show filter 111 in a radially expanded state. It should be understood that the overall conical shape of filter 111 as shown may vary in various embodiments and, therefore, should not be construed as limiting in scope. For example, the shape of filter 111 can change in response to axial and / or rotational movement of filter 111 relative to guidewire 120 (not shown), such that the effective width or diameter of filter 111 increases or decreases with the distance between clamps 115A and 115B.

[0100] 4-5, in some embodiments, filter 111 may include a frame 112. Frame 112 may be formed from one or more structural wires that can be molded and heat set into a desired shape, such as the substantially conical shape shown. Various types of structural wires can be used to form the frame.

[0101] In one embodiment, the structural wire forming the frame 112 may be comprised of expanded filled tubing (DFT) wire or other wire formed at least in part from a radiopaque material. The use of DFT wire for the frame 112 may eliminate the need for separate radiopaque markers on the frame 112. However, in some embodiments, a non-radiopaque structural wire may form the frame 112, with separate radiopaque markers attached to various portions of the frame 112.

[0102] 4-5, an example embodiment of filter 111 may include a braid 113 connected to frame 112. In some embodiments, braid 113 may include a mesh-like braid as shown, or may have another configuration. Braid 113 may function to trap released particles within the interior cavity of filter 111 for collection.

[0103] It will be appreciated that in the illustrated embodiment, the braid 113 may cover slightly more than half of the overall length of the filter 111. Such a configuration should not be construed as limiting in scope. In some embodiments, the braid 113 may cover less than half of the overall length of the filter 111. By way of example, the braid 113 may cover 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the filter 111 in various embodiments.

[0104] In the illustrated example embodiment, it can be seen that approximately 40% of the filter 111 is not covered by the braid 113. In this manner, the frame 112 may remain exposed to allow dislodged particles to enter the filter 111 and become trapped within the braid 113. In one example embodiment, the braid 113 may be positioned to cover a distal portion of the frame 112 of the filter 111, although in some embodiments the opposite configuration may be used.

[0105] In one embodiment, the frame 112 may be constructed from approximately 16 structural DFT wires having a diameter of approximately 0.0030 inches. In some embodiments, the braid 113 may be constructed from approximately 88 finer Nitinol wires having a diameter of approximately 0.0014 inches. However, these values ​​are for illustrative purposes only and should not be construed as limiting. More or fewer wires may be used to form the frame 112 and / or the braid 113. Different sized wires may be used to form the frame 112 and / or the braid 113. Additionally, different materials other than DFT and Nitinol may be used to form the frame 112 and the braid 113, respectively.

[0106] The method of securing braid 113 to frame 112 may vary in various embodiments. Various methods known to those skilled in the art can be used to secure braid 113 to frame 112, including, but not limited to, welding. Additionally, frame 112 and / or braid 113 may be provided with an anticoagulant surface treatment or coating to help inhibit blood clot formation when filter 111 is in use.

[0107] 6-8 illustrate an exemplary embodiment of a delivery catheter 130 that can be used to deliver an embolic protection device 110, including a filter 111, to a target location within the body, with the proximal side on the left and the distal side on the right. FIG. 6 illustrates a side view of an exemplary embodiment of a delivery catheter 130 with interconnected pull assembly 131 and push assembly 136. FIG. 7 illustrates a side view of an exemplary embodiment of the pull assembly 131 of the delivery catheter 130. FIG. 8 illustrates a side view of an exemplary embodiment of the push assembly 136 of the delivery catheter 130.

[0108] 6-7, the delivery catheter 130 includes a pull assembly 131 that may be used to retract the delivery catheter 130 from around the embolic protection device 110, thereby exposing and deploying the filter 111. In some embodiments, the pull assembly 131 may include a housing 132, a distal shaft 134, and a release wire 135.

[0109] In some embodiments, the embolic protection device 110, including the filter 111, can be housed in a radially contracted state within a housing 132 of a delivery catheter 130 during delivery to a target location within a patient. In some embodiments, the housing 132 can comprise a tubular member, as shown in FIG. 7 . The length and width of the housing 132 can vary in various embodiments to accommodate different embodiments of the filter 111. In some embodiments, the housing 132 can include a marker band 133 at or near its proximal end. The marker band 133 can be comprised of a radiopaque material useful for visually indicating when the filter 111 is fully housed within the housing 132.

[0110] In some embodiments, the distal shaft 134 may comprise a solid or tubular elongated member connected between the housing 132 and a release wire 135. Generally, in some embodiments, the filter 111 does not reside within the distal shaft 134 but is disposed only within the housing 132 during delivery. In some embodiments, the release wire 135 may be attached to the proximal end of the distal shaft 134. Pulling the release wire 135 can function to retract the housing 132 from around the filter 111, thereby deploying the filter 111.

[0111] 6 and 8, delivery catheter 130 may include a push assembly 136 that may function to assist in delivery of filter 111 by pushing filter 111 out of housing 132 of pull assembly 131 as housing 132 is retracted. In some embodiments, push assembly 136 may include guidewire lumen 137, cover tube 138, and hypotube 139, as best shown in FIG. 8. Both pull assembly 131 and push assembly 136 may be axially movable independently of one another.

[0112] 8, it can be seen that guidewire lumen 137 can serve the dual functions of acting as a hard stop for filter 111 within housing 132 and of pushing filter 111 out of housing 132 as housing 132 is retracted for filter 111 deployment. In some embodiments, cover tube 138 can comprise a tubular member that covers the primary interface between interconnected pull assembly 131 and push assembly 136, as shown in FIG. 6. In some embodiments, hypotube 139 can serve to house release wire 135 and can be bonded into the proximal end of cover tube 138. Guidewire lumen 137 can be similarly secured within cover tube 138 and extend distally therefrom.

[0113] Figure 9 shows a side view of an exemplary embodiment of a retrieval catheter 140 that can be used to retrieve the embolic protection device 110, along with any particles captured within the filter 111, from a target location within the body after a medical procedure is completed. As shown in Figure 9, the exemplary embodiment of the retrieval catheter 140 may include a distal port 141, a housing 142, one or more marker bands 142A, 142B, and a proximal shaft 143. The retrieval catheter 140 may include a retrieval housing 142 for receiving the filter 111.

[0114] In some embodiments, housing 142 may comprise a tubular member sized to accommodate filter 111 when filter 111 is in a radially collapsed state. In some embodiments, housing 142 may comprise a distal port 141 at its distal end. Distal port 141 may have an inner diameter larger than the inner diameter of housing 142 to minimize fraying of filter 111 during retrieval.

[0115] 9, one or more marker bands 142A, 142B comprised of a radiopaque material may be at least partially coupled to the periphery of the housing 142 to aid in visualization. For example, one or more marker bands 142A, 142B may assist the operator in visualizing that the filter 111 is fully seated within the retrieval housing 142. The number of marker bands 142A, 142B may vary in various embodiments and, therefore, should not be construed as limited in scope by the illustrated example embodiment. For example, more or fewer marker bands than the two illustrated marker bands 142A, 142B may be used.

[0116] 9, in one embodiment, the retrieval housing 142 may include a pair of marker bands 142A, 142B, including a first marker band 142A and a second marker band 142B. In some embodiments, the second marker band 142B may be located near the distal port 141, which is at or near the distal end of the housing 142. In some embodiments, the first marker band 142A may be located axially spaced apart from the second marker band 142B toward the proximal end of the retrieval housing 142. The distance between the marker bands 142A and 142B may vary, but generally may be approximately equal to the length of the filter 111 when in a radially contracted state.

[0117] In some embodiments, the proximal shaft 143 may be connected within the proximal end of the retrieval housing 142 and extend proximally therefrom, as shown in FIG. 9. The proximal shaft 143 may serve to connect the housing to any structural wire or other elongated member that forms the remainder of the proximal length of the retrieval catheter 140. The respective lengths of the housing 142, the proximal shaft 143, and the entire retrieval catheter 140 may vary in various embodiments to suit different applications.

[0118] Figure 10 shows an enlarged view of a portion of the frame 112 and braid 113 of the embolic protection device 110. In some example embodiments, as best shown in Figures 4-5 and 10, all or a portion of the frame 112 may be formed from one or more pairs of structural wires 112A. In other words, some or all of the structural wires forming the frame may be comprised of a single pair of wires 112A that are bundled or fused together to provide increased structural integrity. Such a pair of structural wires 112A may provide structural support for the filter 111 in either the expanded or collapsed state.

[0119] The pair of two structural wires 112A can be adjustable between at least a collapsed state and an expanded state. In the collapsed state, the pair of two structural wires 112A can collapse or contract into a substantially cylindrical shape to fit within a delivery device. In the expanded state, the pair of two structural wires 112A can expand into a variety of shapes, including but not limited to the shapes shown in FIGS. 4-5 and 10 , where the outer shape of the expanded pair of two structural wires 112A can have a larger diameter in the middle and taper to a smaller diameter toward the proximal and distal portions, creating a bulge in the middle.

[0120] The pair of two structural wires 112A may extend between the proximal clamp 115A and the distal clamp 115B, with the pair of two structural wires 112A at the proximal end of the frame 112 clamped or otherwise secured to the proximal clamp 115A, and the pair of two structural wires 112A at the distal end of the frame 112 clamped or otherwise secured to the distal clamp 115B.

[0121] The filter 111 may be secured to and / or secured by a pair of two structural wires 112A. The pair of two structural wires 112A may be disposed along the exterior surface of the filter 111, as shown, or in some embodiments may extend through or across an interior region of the filter 111. The pair of two structural wires 112A may be in contact with one or more regions of the exterior surface of the filter 111. The frame 112 may expand and / or collapse in accordance with the filter 111. The expansion and / or collapse of the filter 111 may function to expand and / or collapse the frame 112, and vice versa.

[0122] Although not shown, in some embodiments, three or more wires may be grouped in a similar manner to form the structural wires of frame 112. Such a configuration for the structural wires can provide improved visibility and structural quality to filter 111.

[0123] 11 shows a side view of another example embodiment of an embolic protection device 110 including a filter 111, a frame 112 to which the filter 111 is attached, a proximal clamp 115A, and a distal clamp 115B. As can be seen, in some embodiments, a tubular member 117 may extend distally from the embolic protection device 110. In the illustrated embodiment, the tubular member 117 is shown attached to and extending distally from the distal clamp 115B, although, as previously mentioned, other configurations may be used in various embodiments.

[0124] With continued reference to Figure 11, it can be seen that in some embodiments, tubular member 117 may comprise an elongated cylindrical tubular member. Tubular member 117 may be of various lengths. Thus, the length of tubular member 117 relative to the rest of the embolic protection device 110 (e.g., frame 112) shown in Figure 11 should not be construed as limiting. In one embodiment, the overall length of tubular member 117 may be approximately 10 mm.

[0125] Because tubular member 117 forms the distal end of embolic protection device 110 during delivery, it may be desirable for at least a portion of tubular member 117 to be flexible or semi-flexible to aid in navigation through tortuous anatomy and provide a gradual transition from high to low stiffness. Such a configuration may provide a smoother transition in pliability between the tip of the distal guidewire and the collapsed filter within the delivery catheter housing. Such a configuration may also be useful in bridging the space between guidewire 120 and the distal tip of delivery catheter 130, as shown in FIG. 2. Thus, as shown in FIG. 11, the elongated tubular member forming tubular member 117 may have a varying durometer or stiffness along its length, with the durometer or stiffness being lower in the distal portion of tubular member 117 than in the proximal portion of tubular member 117.

[0126] In one embodiment, a first portion 117A of the length of the tubular member 117 may have a first durometer or stiffness, and a second portion 117B of the length of the tubular member 117 may have a second durometer or stiffness. The first portion 117A may comprise the proximal portion, and the second portion 117B may comprise the distal portion, such that the durometer or stiffness of the first proximal portion 117A is greater than the durometer or stiffness of the second distal portion 117B. However, in some embodiments, the opposite configuration may be used.

[0127] 11 shows that first proximal portion 117A may comprise a first half of the overall length of tubular member 117 and second distal portion 117B may comprise a second half of the overall length of tubular member 117, it should be understood that different ratios of the lengths of portions 117A, 117B may be used. In one example embodiment in which tubular member 117 may have a length of approximately 10 mm, first proximal portion 117A may have a length of approximately 5 mm and second distal portion 117B may have a length of approximately 5 mm.

[0128] The first and second portions 117A, 117B of the tubular member 117 may be constructed of the same material but with different stiffnesses or durometers, or may be constructed of different materials with different stiffnesses or durometers that are fused or joined together by various methods known to those skilled in the art. For example, the first portion 117A of the tubular member 117 may be constructed of a thermoplastic elastomer such as a polyether block amide (e.g., PEBAX 53D) or other polymeric material having a first durometer, and the second portion 117B of the tubular member 117 may be constructed of a thermoplastic elastomer such as a polyether block amide (e.g., PEBAX 35D) or other polymeric material having a second durometer.

[0129] 11, it can be seen that the first portion 117A and the second portion 117B may each have an angled (e.g., diagonal or beveled) cut surface where they meet. However, it should be understood that in some example embodiments, the connection between the first portion 117A and the second portion 117B may be straight or vertical (e.g., a "butt joint").

[0130] Figures 12A, 12B, 12C, and 12D show an example embodiment of a single-handed placement handle 150 for use with the delivery catheter 130. Figure 12A shows a top perspective view of the placement handle 150 of the embolic protection system 100 in an undeployed state. Figure 12B shows a top perspective view of the placement handle 150 of the embolic protection system 100 in a deployed state. Figure 12C shows a side view of the placement handle 150 of the embolic protection system 100 in an unlocked state. Figure 12D shows a top view of the placement handle 150 of the embolic protection system 100 in a locked state.

[0131] Previously, such handles used with delivery catheters required two-handed operation. By using the example embodiment shown in Figures 12A-12D, a one-handed operation can be employed to deploy the embolic protection device 110 from the delivery catheter 130, thereby freeing the operator's remaining hand.

[0132] 12A-12B, the placement handle 150 may have a substantially elongated configuration having an ergonomic design. In some embodiments, the placement handle 150 may have a proximal end 150B configured to be grasped by one hand of an operator and a distal end 150A from which the release wire 135 of the delivery catheter 130 may extend. Accordingly, it should be understood that the distal end 150A of the placement handle 150 may include a lumen through which the release wire 135 may be inserted and secured to a trigger 152, as described in further detail below.

[0133] 12A-12B, in some embodiments, the installation handle 150 may include a slot 151 extending along at least a portion of the length of its elongated body. While the figures show the slot 151 extending along the top of the installation handle 150, it should be understood that other configurations may be used (e.g., the slot 151 may instead extend along either side or the bottom of the installation handle 150).

[0134] It should be understood that the length of slot 151 may vary in various embodiments, and therefore the range should not be construed as limited to the length of slot 151 shown in the example embodiment shown. The ratio of the length of slot 151 to the overall length of installation handle 150 may vary in various embodiments.

[0135] 12A-12B, in some embodiments, trigger 152 is movably or slidably connected within slot 151, and trigger 152 may be freely movable in either direction (proximally or distally) along at least a portion of the length of slot 151. Trigger 152 may include ergonomic features to assist in holding trigger 152 with one finger. Release wire 135 of delivery catheter 130 may be attached or connected (directly or indirectly) to trigger 152, such that movement of trigger 152 in the proximal direction pulls release wire 135, and movement of trigger 152 in the distal direction pushes release wire 135.

[0136] In some embodiments, the placement handle 150 can be grasped in one hand (or both hands), such as at or near the proximal end 150B, and one or more fingers or a thumb can be used to retract the trigger 152 proximally and pull the release wire 135 to expose and expand the embolic protection device 110. Figure 12A shows a top perspective view of the placement handle 150 and trigger 152 in an undeployed state. Figure 12B shows a top perspective view of the placement handle 150 and trigger 152 in a deployed state.

[0137] 12C-12D, in some embodiments, the deployment handle 150 may include a locking mechanism 155 operable to lock the trigger 152 in an undeployed state, thereby preventing premature deployment of the embolic protection device 110. In some embodiments, the locking mechanism 155 may include a tab or other structural element that is hinged or otherwise adjustable between an unlocked state, as shown in FIG. 12C, and a locked state, as shown in FIG. 12D.

[0138] 12C, in the unlocked state, locking mechanism 155 is adjusted out of the path of travel of trigger 152 along slot 151. As shown in FIG. 12D, in the locked state, locking mechanism 155 is adjusted to cross or cover slot 151 proximally relative to trigger 152 when trigger 152 is in the installed state, thereby preventing trigger 152 from moving proximally along slot 151.

[0139] Figure 13A shows a perspective view of a retrieval catheter 140 positioned to retrieve an embolic protection device from the embolic protection system 100. Figure 13B shows a perspective view of an embolic protection device 110 being retrieved by the retrieval catheter 140 from the embolic protection system 100, according to an example embodiment of the present invention. As shown in Figures 13A-13B, the distal port 141 may include an inwardly sloping surface 141A to prevent or mitigate fraying of the filter 111 as it enters the distal port 141. The inwardly sloping surface 141A may include a tapered end on the inside of the distal port 141.

[0140] 14 shows a side view of an adjustment handle 165 for use with the retrieval catheter 140 of the embolic protection system 100. In some embodiments, the adjustment handle 165 can be used to adjust or deflect the distal end of the retrieval catheter 140 for improved maneuverability and to aid in positioning the retrieval catheter 140 for retrieval of the embolic protection device 110.

[0141] 14, in some embodiments, adjustment handle 165 may be constructed of a flexible or semi-flexible material such that it is adjustable between a compressed and an uncompressed state. In some embodiments, adjustment handle 165 may also be constructed of a resilient material such that it naturally returns to its original shape (e.g., its uncompressed state) when no force is applied. In some example embodiments, adjustment handle 165 may function similar to a leaf spring.

[0142] In some embodiments, adjustment handle 165 may have a substantially pear-shaped configuration with an internal opening so that adjustment handle 165 may be compressed inward. As shown in FIG. 14 , in some embodiments, adjustment handle 165 may have a lumen extending its entire length within which proximal shaft 143 of retrieval catheter 140 is disposed.

[0143] With the proximal shaft 143 secured within the adjustment handle 165, compression of the adjustment handle 165, which expands the adjustment handle 165 into a compressed configuration, pulls the proximal shaft 143, as shown in Figure 14, and can thereby function to deflect the distal port 141 of the retrieval catheter 140. Thus, in use, an operator can compress the adjustment handle 165 with one hand to deflect the distal port 141 of the retrieval catheter 140, providing better maneuverability when positioning the distal port 141 for retrieval of the embolic protection device 110.

[0144] FIG. 15 shows a side view of a cleaning system for cleaning the retrieval catheter 140, such as when the retrieval catheter 140 is still packaged by the manufacturer. Physicians and other healthcare professionals have no choice but to clean the catheter 140 after removing it from the packaging. This cleaning process can often be difficult if the physician or other healthcare professional has hand tremors or is nervous. Cleaning the retrieval catheter 140 before removing it from the packaging allows the retrieval catheter 140 to be secured or held during the cleaning process, preventing any nervousness or hand tremors from affecting the cleaning process.

[0145] 15, the irrigation system may include a syringe 160 that stores a volume of fluid. The syringe 160 may be in fluid communication with tubing 161, which may itself be in fluid communication with the recovery catheter 140. In some example embodiments, the syringe 160 may be connected directly to the recovery catheter 140 to perform the irrigation without any additional tubing 161. In some embodiments, the tubing 161 may be constructed of PVC tubing. The recovery catheter 140 is shown with its distal end connected to a packaging coil 162, as it is in its original packaging.

[0146] In use, before removing recovery catheter 140 from its original packaging or before removing packaging coil 162, recovery catheter 140 can be flushed by introducing a fluid (e.g., saline) into and expelling it from syringe 160. Syringe 160 can be connected to a luer fitting or other port on the end of flexible tubing 161, which is in fluid communication with recovery catheter 140. The plunger of syringe 160 can then be advanced to expel fluid through tubing 161 and recovery catheter 140, thereby flushing recovery catheter 140. Recovery catheter 140 can then be removed from its original packaging and is ready for use.

[0147] In use, the embolic protection device 110 may first be delivered to a target location within a blood vessel. Typically, the embolic protection device 110 may be delivered to a location distal to where a medical procedure will be performed, such as, but not limited to, a stenting procedure, an angioplasty procedure, or any other procedure where there is a risk of particle dislodgement. An example of a method for delivery and placement of an embolic protection device is disclosed in U.S. Patent No. 1,166,804, which is incorporated herein by reference in its entirety.

[0148] The embolic protection device 110, including the filter 111, can be delivered to the target location by a delivery catheter 130. In some embodiments, the filter 111 can be compressed to a radially contracted state and housed entirely within the housing 132 of the delivery catheter 130. The delivery catheter 130 can then be advanced to the target location by a variety of methods known to those skilled in the art.

[0149] In some embodiments, once the target location is reached, a release wire 135 of a pull assembly 131 of the delivery catheter 130 can be pulled to retract the housing 132 from around the filter 111. As this operation is performed, a push assembly 136 of the delivery catheter 130 can also function to push the filter 111 out of the housing 132. The configuration of the delivery catheter 130, including the use of both the pull assembly 131 and the push assembly 136, allows the filter 111 to be deployed without changing its position within the blood vessel, thereby reducing the tendency of the filter 111 to become dislodged during deployment.

[0150] In some embodiments, once filter 111 is deployed, it can be generally expanded to a radially expanded state distal to the location where the medical procedure is being performed. Delivery catheter 130 can be removed. Particles that may become dislodged during the medical procedure can enter frame 112 of filter 111 and be trapped within braid 113, thereby preventing various complications caused by such dislodged particles.

[0151] In some embodiments, once the medical procedure is complete, the filter 111 can be removed from the patient using the retrieval catheter 140. The retrieval catheter 140 can be advanced to the embolic protection device 110, and the filter 111 can be threaded through the distal port 141 of the retrieval catheter 140 and retracted into the housing 142. The larger inner diameter of the distal port 141 compared to the housing 142 prevents fraying of the filter 111 during retrieval. Once inside the housing 142, the filter 111 collapses to a radially contracted state. Marker bands 142A, 142B can be used to visualize when the filter 111 is fully seated within the housing 142, after which the retrieval catheter 140 can be removed from the patient's body.

[0152] 16A-16C illustrate an example of a proximal region of a delivery catheter 130 in which a guidewire 146 can be constrained within a lumen (e.g., first lumen 144a or second lumen 144b) of the delivery catheter 130. The delivery catheter 130 can have multiple lumens, such as a double-lumen catheter (FIG. 16B) or a triple-lumen catheter (not shown). FIG. 16A illustrates the proximal region of a delivery catheter 130 having multiple lumens. As shown, the guidewire 146 can be housed within the first lumen (e.g., 144a) of the delivery catheter 130, leaving the second lumen 144b (or third lumen 144c in a three-lumen catheter, not shown) available as an additional working lumen. In one example embodiment, the embolic protection device 110 can be navigated and manipulated to an anatomical target through the second lumen 144b. The use of a multi-lumen catheter allows the operator to better manage the embolic protection device 110, the guidewire 146, and any other components that may be inserted into the multi-lumen catheter, because the components in the first lumen 144a are isolated from the components in the second lumen 144b to avoid entanglement, interference, and / or other adverse interactions.

[0153] FIG. 16B shows cross section BB of the delivery catheter 130 of FIG. 16A. As shown, in some embodiments, the delivery catheter 130 may include a first lumen 144a and a second lumen 144b. In some embodiments, the diameter of the first lumen 144a and the diameter of the second lumen 144b may be the same or different. In one embodiment, the diameter of the first lumen 144a may be larger than the diameter of the second lumen 144b. In some embodiments, the diameter of the first lumen 144a may be smaller than the diameter of the second lumen 144b. In the illustrated example, the guidewire 146 may be constrained within the first lumen 144a. In some embodiments, the second lumen 144b of the delivery catheter 130 may be configured to accommodate the embolic protection device 110, in which case the embolic protection device 110 can be maneuvered via the second lumen 144b to the target location where the medical procedure is to be performed.

[0154] FIG. 16C shows cross section CC of the delivery catheter 130 of FIG. 16A. As shown in FIG. 16C, in some embodiments, the proximal region of the delivery catheter 130 may further include a slit 170 (FIG. 16C) spanning one or more of the multiple lumens. For example, as shown in FIGS. 16A and 16C, the slit 170 may be located between the first lumen 144a and the outer surface of the delivery catheter 130 and extend a length L1 from the proximal tip of the delivery catheter 130 to the distal region of the delivery catheter 130. In some embodiments, the slit 170 may extend distally from the proximal tip to a position adjacent to the hemostasis valve. In some embodiments, the slit 170 may extend through the dual-lumen tube to an RX port distal to the hemostasis valve. When the user withdraws the delivery catheter 130, the delivery catheter 130 may become detached from the guidewire 146.

[0155] In some embodiments, slit 170 allows guidewire 146 and the proximal region of the guidewire handle to be spaced a distance D1 from the delivery catheter, thereby improving ease of manipulation by providing the operator with sufficient working space to manipulate embolic protection device 110 to a target location via second lumen 144b. In one example, slit 170 extends a length L1 of approximately 10 cm, 20 cm, 30 cm, 40 cm, or 50 cm.

[0156] FIG. 17 illustrates an example of the distal end 121 of the guidewire 120 of the embolic protection device 110 described above. In some embodiments, the distal end 121 may include a corewire 180 with one or more coils 186 secured therearound. In the illustrated example, the corewire 180 may include one or more narrowed regions 182 and / or one or more expanded regions 184. In some embodiments, the one or more expanded regions 184 may have a larger diameter than the narrowed region 182 and may taper proximally and / or distally. In some embodiments, the corewire 180 may be flattened (e.g., rectangular in cross section) to improve the bendability of the corewire 180. In some embodiments, a flattened corewire 180 may improve vascular access by efficiently transmitting torque from the proximal end to the distal tip of the guidewire 120 and may also facilitate better control and trackability during guidewire delivery. In some embodiments, one or more coils 186 are secured to a distal portion of core wire 180, such as the distal end of core wire 180, by various methods known to those skilled in the art, such as laser welding. In one example, one or more coils 186 may be constructed from various materials, including platinum-tungsten. In one example, distal end 121 of guidewire 120 may have a length of approximately 60-65 mm.

[0157] Terms

[0158] Example embodiments are described in the following numbered clauses:

[0159] Item 1. The embolic protection system may include an embolic protection device with a filter to capture detached particles, a delivery catheter for delivering and deploying the embolic protection device, and a retrieval catheter for retrieving the embolic protection device along with the captured particles.

[0160] Item 2. The embolic protection device may include an elongate member, such as a guidewire or corewire, and a filter movably connected to the elongate member.

[0161] Paragraph 3 The embolic protection device of paragraph 2 may include a filter that is axially movable relative to the elongate member.

[0162] Paragraph 4 The embolic protection device according to paragraph 2 or 3 may include a filter that is rotatable relative to the elongated member.

[0163] Paragraph 5 The embolic protection device according to any one of paragraphs 2 to 4 may comprise one or more clamps movably connected to the elongated member.

[0164] Paragraph 6. The embolic protection device of paragraph 5 may comprise a proximal end of the filter secured to a first clamp and a distal end of the filter secured to a second clamp.

[0165] Section 7. The embolic protection device of any of the preceding sections may comprise an anticoagulant surface treatment applied or coated onto the filter.

[0166] Section 8. The embolic protection device of any of the preceding sections may comprise a filter having a frame formed from one or more structural wires.

[0167] Paragraph 9. The embolic protection device of paragraph 8 may comprise a plurality of structural wires, each of which is comprised of a pair of DFT wires.

[0168] Clause 10. The embolic protection device of clause 8 and / or clause 9 may comprise a braid connected to the frame.

[0169] Paragraph 11 The embolic protection device according to any one of paragraphs 8 to 10 may comprise a braid connected to the frame so as to cover at least half of the entire length of the frame.

[0170] Section 12 The embolic protection device according to any of the preceding sections may further comprise a filter stopper connected to the elongated member within the filter.

[0171] Clause 13: The delivery catheter may include a pull assembly for retracting a housing from around the filter and a push assembly for pushing the filter out of the housing.

[0172] Clause 14. The delivery catheter of clause 13 may include a pull assembly having a housing, a marker band, a distal shaft, and / or a release wire.

[0173] Clause 15. The delivery catheter of clause 13 and / or clause 14 may include a push assembly having a guidewire lumen, a cover tube, and a hypotube.

[0174] Clause 16. A method of delivering an embolic protection device may include placing a filter within a housing while the filter is in a radially collapsed or contracted state, delivering the housing to a target location, and retracting the housing from around the filter to expose and place the filter in a radially expanded state.

[0175] Clause 17. The method of clause 16 may include pushing the filter out of the housing.

[0176] Clause 18: A method of delivering an embolic protection device may include placing a filter within a delivery catheter, delivering the delivery catheter to a target vessel, and deploying the embolic protection device from the delivery catheter.

[0177] Clause 19. The method of clause 18 may include using a pull assembly to retract the delivery catheter from around the embolic protection device.

[0178] Clause 20. The method of clause 18 and / or clause 19 may comprise advancing the embolic protection device from the delivery catheter using a push assembly.

[0179] Clause 21: The method of any of clauses 18-20 may comprise placing the embolic protection device at a location distal to a location where a medical procedure is being performed.

[0180] Clause 22: A method of capturing one or more detached particles may comprise delivering and placing a filter within a blood vessel to capture any of the one or more detached particles.

[0181] Clause 23. The method of clause 22 may include expanding the filter to a radially expanded state and adjusting the radially expanded state by moving the filter axially and / or rotationally relative to an internal guidewire.

[0182] Clause 24: A method for retrieving a filter and captured particles may include delivering a retrieval catheter to a target location, positioning the filter within the retrieval catheter, and retrieving the retrieval catheter from within the patient's body.

[0183] Clause 25. The method of clause 24 may include advancing the retrieval catheter around the filter.

[0184] While the present invention has been described with respect to particular embodiments and applications, those skilled in the art can, in light of this teaching, create further embodiments and modifications without departing from the spirit of the invention as set forth in the claims or beyond the scope of the invention as set forth in the claims. Accordingly, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting the scope of the invention.

Claims

1. A thin elongated member; a first clamp movably connected to the elongated member; a filter having a braided mesh; the filter is adjustable between a radially contracted state and a radially expanded state; the filter is connected to the first clamp to allow movement of the filter relative to the elongate member when the filter is in the radially expanded state. Embolic protection devices.

2. The embolic protection device of claim 1, further comprising a second clamp connected to the elongate member, the proximal end of the filter being connected to the second clamp.

3. The embolic protection device of claim 2 , wherein the second clamp is movably connected to the elongate member.

4. The embolic protection device of claim 3 , wherein a distal end of the filter is connected to the first clamp and a proximal end of the filter is connected to the second clamp.

5. The embolic protection device of claim 1 , wherein the braided mesh covers at least half of the overall length of the filter.

6. The embolic protection device of claim 1 , wherein the filter is axially movable relative to the elongate member when the filter is in the radially expanded state.

7. The embolic protection device of claim 1 , wherein the filter is rotatable relative to the elongate member when the filter is in the radially expanded state.

8. The embolic protection device of claim 1 , wherein the filter is movable both axially and rotationally relative to the elongate member when the filter is in the radially expanded state.

9. The embolic protection device of claim 1 , wherein the filter further comprises a plurality of structural wires.

10. The embolic protection device of claim 9 , wherein the plurality of structural wires comprises a plurality of wire pairs.

11. The embolic protection device of claim 9 , wherein the plurality of structural wires is comprised of a plurality of stretch-filled tubing (DFT) wires.

12. The embolic protection device of claim 1 , further comprising a stop connected to the elongated member to limit movement of the filter relative to the elongated member.

13. The embolic protection device of claim 1 , wherein the filter comprises an anticoagulant surface treatment.

14. The embolic protection device of claim 1 , further comprising a radiopaque coil disposed about a distal portion of the elongate member.

15. The embolic protection device of claim 1 , wherein the filter comprises a conical shape when in the radially expanded state.

16. a filter assembly; a delivery catheter assembly; The filter assembly includes: A guide wire; a filter movably connected to the guidewire so as to be movable relative to the guidewire; the filter is adjustable between a radially contracted state and a radially expanded state, the filter having a conical shape when in the radially expanded state; The delivery catheter assembly includes: a housing for containing the filter assembly prior to installation; a release wire connected to the housing for retracting the housing from around the filter. Embolic protection system.

17. The embolic protection system of claim 16, wherein the housing comprises at least one marker band at or near the distal end.

18. 17. The embolic protection system of claim 16, further comprising a retrieval catheter assembly having a retrieval housing for receiving the filter assembly.

19. 20. The embolic protection system of claim 18, wherein the retrieval catheter assembly comprises a distal port, the inner diameter of the distal port being larger than the inner diameter of the retrieval housing.

20. 20. The embolic protection system of claim 18, wherein the retrieval housing comprises a first marker band and a second marker band, the first marker band being located at or near a distal end of the retrieval housing and the second marker band being spaced proximally relative to the first marker band.

21. 20. The embolic protection system of claim 19, wherein the retrieval catheter assembly further comprises a proximal shaft extending into the proximal end of the retrieval housing.

22. A thin elongated member; clamping means movably connected to said elongated member; a filter means for capturing embolic particles; the filter means being adjustable between a radially contracted state and a radially expanded state; the filter means is connected to the clamping means for both radial and rotational movement relative to the elongate member when the filter means is in the radially expanded condition. Embolic protection devices.

23. a filter having a plurality of structural wires and a braided mesh, the filter being adjustable between a radially contracted state and a radially expanded state, the filter having a conical shape when in the radially expanded state; a tubular member connected to the filter and extending distally from the filter, the tubular member having a proximal end and a distal end, the proximal end of the tubular member having a durometer hardness greater than the distal end of the tubular member; 1. An embolic protection system comprising:

24. 24. The embolic protection system of claim 23, wherein the tubular member comprises an elongated cylindrical shape.

25. 25. The embolic protection system of claim 24, wherein a first portion of the tubular member comprises a first durometer hardness and a second portion of the tubular member comprises a second durometer hardness, the first durometer hardness being greater than the second durometer hardness.

26. 26. The embolic protection system of claim 25, wherein the first portion comprises a first half of the overall length of the tubular member and the second portion comprises a second half of the overall length of the tubular member.

27. 27. The embolic protection system of claim 26, wherein the first portion comprises a length of about 5 mm and the second portion comprises a length of about 5 mm.

28. 26. The embolic protection system of claim 25, wherein the first portion and the second portion are each composed of a polyether block amide.

29. 30. The embolic protection system of claim 28, wherein the first portion is constructed of PEBAX 53D and the second portion is constructed of PEBAX 35D.

30. 26. The embolic protection system of claim 25, wherein the first portion and the second portion are constructed of different materials.

31. 24. The embolic protection system of claim 23, wherein a distal end of the filter is connected to a clamp, and the tubular member is connected to the clamp and extends distally therefrom.

32. a filter that is adjustable between collapsed and expanded states; a delivery catheter assembly including a housing for receiving a filter prior to deployment and a release wire connected to the housing for retracting the housing from around the filter; an installation handle including a slot and a trigger movably disposed within the slot, the release wire connected to the trigger; the trigger is adjustable between an un-installed state and an installed state; Embolic protection system.

33. 33. The embolic protection system of claim 32, wherein the trigger is located at or near a distal end of the slot when in the undeployed state.

34. 34. The embolic protection system of claim 33, wherein the trigger is located at or near the proximal end of the slot when in the deployed state.

35. 34. The embolic protection system of claim 33, wherein the trigger is operable to retract the housing by pulling the release wire when the trigger is in the deployed state.

36. 34. The embolic protection system of claim 33, further comprising a locking mechanism adjustable between a locked state, in which movement of the trigger is minimized or prevented, and an unlocked state, in which the trigger is free to move along the slot.

37. 37. The embolic protection system of claim 36, wherein the locking mechanism is hingedly adjustable between the locked and unlocked states.

38. a filter that is adjustable between collapsed and expanded states; a retrieval catheter for retrieving the filter from a patient, the retrieval catheter having a retrieval housing that receives the filter; the retrieval housing includes a distal port, the inner diameter of the distal port being larger than the inner diameter of the retrieval housing, the distal port including an inwardly sloping surface or an inwardly tapered distal end to prevent fraying of the filter as it enters the distal port; Embolic protection system.

39. a filter that is adjustable between collapsed and expanded states; a retrieval catheter for retrieving the filter from a patient, the retrieval catheter comprising a retrieval housing for receiving the filter and a proximal shaft; an adjustment handle connected to the proximal shaft of the retrieval catheter, the adjustment handle being adjustable between a compressed state and an uncompressed state; Compression of the adjustment handle to the compressed state is operable to deflect the distal end of the retrieval catheter. Embolic protection system.

40. 40. The embolic protection system of claim 39, wherein the adjustment handle is comprised of a leaf spring.

41. 40. The embolic protection system of claim 39, wherein the adjustment handle is constructed from a flexible or semi-flexible resilient material.

42. 1. A method of cleaning a catheter, comprising: providing a catheter secured in its original packaging; attaching a tube to the catheter; attaching a syringe containing a volume of fluid to the tube; advancing the plunger of the syringe to direct the fluid through the catheter while keeping the catheter fixed in its original packaging; A method comprising:

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