Embolic protection system

Abstract

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

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 476,533, filed on December 21, 2022, entitled “Embolic Protection System,” the entire contents of which are incorporated herein by reference. Background Art

[0003] During certain medical procedures, such as, but not limited to, carotid artery stenting, doctors' surgical tools can sometimes dislodge embolic particles. These embolic particles, which may include thrombi, atherosclerosis, and lipids, can cause downstream vascular blockages. Consequently, these embolic particles can lead to serious complications, such as stroke or even death.

[0004] One way to reduce the risk of such complications is to deploy an embolic protection device, such as a filter, downstream of the surgical site to capture any particles that may be dislodged. Once captured, the filter can be closed and removed from the patient so that the captured embolic particles cannot escape from the filter.

[0005] It is contemplated that such filters may be adjustable in one or more ways to reduce the risk of various adverse conditions, such as vasospasm or vascular dissection. It is also contemplated that such filters may include an integrated guidewire so that a separate guidewire is not required during the procedure, may include a radiopaque wire to improve visibility, and may include an anti-clot surface treatment to reduce clot formation. Summary of the Invention

[0006] The present invention discloses an embolic protection system that can be delivered to a target location within a patient's body, deployed to capture any displaced particles, and removed from the patient's body.

[0007] In one exemplary embodiment, an embolic protection system may include an embolic protection device for capturing any displaced particles, a delivery catheter assembly for delivering the embolic protection device, and a retrieval catheter assembly for retrieving the embolic protection device including any captured particles.

[0008] In an exemplary embodiment, an embolic protection device may include a filter comprising a braided mesh and / or one or more structural wires.

[0009] In an exemplary embodiment, the embolic protection device may include one or more clamps for attaching the embolic protection device to an elongated member, such as a guidewire.

[0010] In an exemplary embodiment, one or more clamps may be removably connected to the guidewire.

[0011] In an exemplary embodiment, a tubular member (eg, an elongated cylindrical member) can extend distally from a distal clamp of the embolic protection device to improve visualization.

[0012] In one exemplary embodiment, the tubular member may include a variable durometer along its length.

[0013] In one exemplary embodiment, the first portion of the tubular member may include a first hardness, and the second portion of the tubular member may include a second hardness.

[0014] In an exemplary embodiment, the hardness of the proximal portion of the tubular member may be greater than the hardness of the distal portion of the tubular member.

[0015] In one exemplary embodiment, the proximal portion of the tubular member can include a first material, while the distal portion of the tubular member can include a second material.

[0016] In one exemplary embodiment, the first material may include PEBAX 53D and the second material may include PEBAX 35D.

[0017] In an exemplary embodiment, the filter is adjustable between a radially compressed configuration and a radially expanded configuration.

[0018] In one exemplary embodiment, the filter may include a conical shape when in the radially expanded configuration.

[0019] In one exemplary embodiment, the filter may be coupled to one or more clamps such that the filter may be moved relative to the underlying elongate member when the filter is in the radially expanded configuration.

[0020] In one exemplary embodiment, the filter can be connected to the elongated 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.

[0021] In an exemplary embodiment, the filter is axially movable relative to the elongate member when the filter is in the radially expanded configuration.

[0022] In an exemplary embodiment, the filter is rotationally movable relative to the elongate member when the filter is in the radially expanded configuration.

[0023] In an exemplary embodiment, the filter is rotatable and axially movable relative to the elongate member when the filter is in the radially expanded configuration.

[0024] In an exemplary embodiment, the filter may include a plurality of wire pairs.

[0025] In an exemplary embodiment, the filter may include a braided mesh and one or more structural wires. The one or more structural wires may include one or more drawn filler tubing (DFT) wires. The structural wires may include paired wires such that one or more wire pairs form at least a portion of the filter.

[0026] In an exemplary embodiment, a stopper can be connected to the elongated member to limit the movement of the filter relative to the elongated member. The stopper can be used to limit the axial translation of the filter. The stopper can also or alternatively be used to interconnect the various parts of the elongated member.

[0027] In one exemplary embodiment, the filter (eg, structural filaments and / or braided mesh) can be treated with an anti-clot surface treatment to help prevent clot formation during use.

[0028] In one exemplary embodiment, a radiopaque band, wire, or coil may be disposed around the distal end or portion of the elongate member to aid in visualization of the distal end of the elongate member during use.

[0029] In one exemplary embodiment, one or more structural filaments may extend across the length of the filter, and the mesh braid may extend along only about 40%-60% of the filter length.

[0030] In an exemplary embodiment, an embolic protection system can include a filter assembly and a delivery catheter assembly, the filter assembly including a guidewire and a filter movably connected to the guidewire, the delivery catheter assembly including a sheath for storing the filter assembly prior to deployment and a release wire connected to the sheath for retracting the sheath from around the filter.

[0031] In one exemplary embodiment, the deployment handle may be connected to the release wire to allow for pushing or pulling the release wire via a single-handed operation.

[0032] In one exemplary embodiment, the deployment handle can include a trigger movably or slidably coupled within the slot such that the trigger can be retracted proximally to retract the release wire, thereby deploying the filter of the embolic protection device.

[0033] In one exemplary embodiment, the deployment handle may include a locking mechanism for locking the trigger in the undeployed configuration, thereby preventing premature deployment of the embolic protection device.

[0034] In an exemplary embodiment, the sheath can include at least one marker band.The at least one marker band can be located at or near the distal end of the sheath.

[0035] In an exemplary embodiment, the embolic protection system may further include a retrieval catheter assembly for retrieving the embolic protection device and any captured particles contained therein after use.

[0036] In an exemplary embodiment, the retrieval catheter assembly may include one or more marker bands to facilitate visualization when the filter is fully contained within the retrieval catheter assembly.

[0037] In an exemplary embodiment, the distal opening of the retrieval conduit may include an internal beveled surface or an inwardly tapered distal end to prevent abrasion of the filter as it enters the distal opening of the retrieval conduit.

[0038] In one exemplary embodiment, an adjustment handle may be coupled to the retrieval catheter to selectively deflect or movably adjust the distal end of the retrieval catheter to enhance navigability when positioning the retrieval catheter to retrieve the filter.

[0039] In an exemplary embodiment, the retrieval catheter can be flushed with fluid (e.g., saline) in its original packaging by filling a syringe with the fluid, connecting the syringe to the retrieval catheter fluid (e.g., by using flexible tubing), and expelling the fluid from the syringe to flush the fluid out of the retrieval catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The following drawings are included to illustrate certain aspects of the present disclosure and should not be construed as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalent substitution in form and function, as will occur to one of ordinary skill in the art and having the benefit of this disclosure. These and other aspects, features, and advantages that can be achieved by embodiments of the present disclosure will become apparent and elucidated from the following description of embodiments of the present disclosure, with reference to the accompanying drawings, in which:

[0041] Figure 1 An embolic protection device is shown in a radially expanded configuration according to an exemplary embodiment of the present disclosure.

[0042] Figure 2 A side view of an embolic protection system in a radially compressed configuration is shown according to an exemplary embodiment of the present disclosure.

[0043] Figure 3 A side view of an embolic protection device of an embolic protection system including a filter movably connected to an elongated member, such as a guidewire, is shown in a radially expanded configuration according to an exemplary embodiment of the present disclosure.

[0044] Figure 4A first perspective view of a filter for use with an embolic protection device in a deployed configuration according to an exemplary embodiment of the present disclosure is shown.

[0045] Figure 5 A second perspective view of a filter for use with an embolic protection device in a deployed configuration is shown, according to an exemplary embodiment of the present invention.

[0046] Figure 6 A side view of a delivery catheter of an embolic protection system including interconnected push-pull assemblies is shown according to an exemplary embodiment of the present invention.

[0047] Figure 7 A side view of a pulling assembly of a delivery catheter of an embolic protection system according to an exemplary embodiment of the present disclosure is shown.

[0048] Figure 8 A side view of a pusher assembly of a delivery catheter of an embolic protection system according to an exemplary embodiment of the present disclosure is shown.

[0049] Figure 9 A side view of a retrieval catheter of an embolic protection system according to an exemplary embodiment of the present invention is shown, which may be used to retrieve an embolic protection device.

[0050] Figure 10 Shown is a close-up view of the frame and braid of an embolic protection device according to an exemplary embodiment of the present disclosure.

[0051] Figure 11 A side view of another example of an embolic protection device of an embolic protection system according to an exemplary embodiment of the present disclosure is shown.

[0052] Figure 12A An upper perspective view of a deployment handle of an embolic protection system in an undeployed configuration is shown, according to an exemplary embodiment of the present invention.

[0053] Figure 12B An upper perspective view of a deployment handle of an embolic protection system in a deployed configuration is shown, according to an exemplary embodiment of the present invention.

[0054] Figure 12C A side view of a deployment handle of an embolic protection system in an unlocked configuration is shown according to an exemplary embodiment of the present disclosure.

[0055] Figure 12D A top view of a deployment handle of an embolic protection system in a locked configuration is shown according to an exemplary embodiment of the present disclosure.

[0056] Figure 13AA perspective view of a retrieval catheter positioned for retrieving an embolic protection device of an embolic protection system is shown, according to an exemplary embodiment of the present invention.

[0057] Figure 13B A perspective view of an embolic protection device being retrieved by a retrieval catheter of an embolic protection system is shown, according to an exemplary embodiment of the present invention.

[0058] Figure 14 A side view of an adjustment handle for use with a retrieval catheter of an embolic protection system is shown, according to an exemplary embodiment of the present invention.

[0059] Figure 15 A side view of an irrigation system for flushing a retrieval catheter of an embolic protection system is shown, according to an exemplary embodiment of the present disclosure.

[0060] Figure 16A A proximal region of a delivery catheter having multiple lumens is shown, according to an exemplary embodiment of the present invention.

[0061] Figure 16B An exemplary embodiment according to the present disclosure is shown. Figure 16A The cross section BB of the delivery conduit.

[0062] Figure 16C An exemplary embodiment according to the present disclosure is shown. Figure 16A The cross section CC of the delivery conduit.

[0063] Figure 17 An example of a guidewire distal end of an embolic protection device according to an exemplary embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0064] Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. However, the present disclosure can be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided to make this disclosure thorough and complete and to fully convey the scope of the disclosure to those skilled in the art. The terms used in the detailed description of the embodiments illustrated in the accompanying drawings are not intended to limit the present disclosure. In the accompanying drawings, like numbers represent like elements.

[0065] For purposes of the terminology described hereinafter, the terms clot, thrombus, embolus, and obstruction may be used synonymously.

[0066] For purposes of this specification, when referring to a value, the use of terms such as "about," "approximately," or "approximately" may be understood to mean within 5% (greater than or less than) of the stated value, inclusive.

[0067] Disclosed herein are exemplary embodiments of embolic protection systems that may include, for example, an embolic protection device for capturing displaced embolic particles, a delivery catheter assembly for delivering the embolic protection device, and a retrieval catheter assembly for retrieving the embolic protection device including any captured particles.

[0068] The embolic protection device can be deployed in the vascular system, such as the carotid artery, distal to a medical procedure known to have the potential to dislodge one or more particles, such as stent implantation or angioplasty. If one or more particles become dislodged during the procedure, the embolic protection device can capture the dislodged particles so they can be safely removed from the body.

[0069] The embolic protection device can include an elongated member, such as an integrated guidewire, to which the filter can be removably connected. The elongated member can extend completely through the filter and extend distally and proximally from the filter. The elongated member can include two or more distinct portions connected together. For example, the elongated member can include a proximal guidewire and a distal guidewire.

[0070] The distal portion of the elongated member may include a radiopaque marker to facilitate tracking when navigating to a target location within the body. The radiopaque marker may include a radiopaque material known to be visible through various imaging devices. The radiopaque marker may include a band or coil that is secured to the distal portion of the elongated member, such as its distal end, by various methods known in the art, such as welding.

[0071] The filter can include a framework. The framework can include one or more structural wires that are woven, braided, or coiled to form a substantially conical structure with an inner cavity. At least a portion of the one or more structural wires can be connected to a braid, such as a mesh braid, for capturing any displaced particles. For example, the distal half of the filter can include a braid for capturing debris, and the proximal half of the filter can include no braid, but can only include one or more structural wires to allow displaced particles to enter the inner cavity of the filter and be captured therein.

[0072] The filter can be movably coupled to the elongated member. For example, the filter can be axially movable along the elongated member and / or rotationally movable relative to the elongated member. Such movement of the frame relative to the elongated member can reduce the likelihood of vasospasm or dissection when manipulating the elongated member (e.g., during positioning of the filter).

[0073] The filter can be connected to the elongated member by one or more clamps. For example, the filter can be connected to the elongated member by a first clamp at the proximal end of the filter and by a second clamp at the distal end of the filter. The filter can be fixedly attached to the clamp. One or more clamps can be movably connected to the elongated member such that the clamp can slide axially and / or rotate relative to the elongated member, thereby allowing the filter to perform the same movement.

[0074] The filter can be adjusted between at least two configurations. For example, the filter can be adjusted between a radially compressed configuration and a radially expanded configuration. In the radially compressed configuration, the filter can be compressed to fit within a tubular sheath, such as a delivery catheter. In the radially expanded configuration, the filter can be expanded to form a substantially conical shape with a partially exposed lumen for capturing any displaced particles.

[0075] The distal tubular tip can be connected to a clamp located at the distal or proximal end of the filter. The distal tubular tip can be positioned at least partially over or around the elongated member. The distal tubular tip can be composed of a radiopaque material to provide visualization of the distal end of the filter using various imaging devices to facilitate tracking.

[0076] A stopper may be attached to the elongated member and located distally of the clamp near or proximal to the proximal end of the filter. The stopper may be used to limit axial translation of the filter. The stopper may also provide a connection between different portions of the elongated member, such as connecting a distal guidewire to a proximal guidewire, which together may form the elongated member.

[0077] A delivery catheter assembly can be used to transport and deploy an embolic protection device at a target location during a medical procedure. The delivery catheter assembly can be tracked to the target location, such as a location in the carotid artery, where the embolic protection device is positioned. A release wire can then be pulled, which retracts the sheath of the delivery catheter assembly, allowing the embolic protection device to deploy within the target vessel.

[0078] To achieve deployment of the release wire, the delivery catheter assembly may include a pair of subassemblies that can move axially independently of each other. For example, the delivery catheter assembly may include a pulling subassembly and a pushing subassembly that are interconnected to form an integrated delivery catheter assembly.

[0079] The pull subassembly can include a sheath, a marker band, a distal shaft, and a release wire. The sheath can include a tubular component in which the embolic protection device is positioned prior to deployment. The marker band can be composed of a radiopaque material to indicate when the embolic protection device is completely within the sheath. The distal shaft can include a cylindrical member (solid or tubular) that connects the sheath to the release wire. The release wire can include an elongated wire that can retract the sheath when pulled.

[0080] The push subassembly can include a guidewire lumen, a cover tube, and a hypotube. The guidewire lumen can serve as a hard stop when the embolic protection device is in the sheath. When the sheath is retracted, the guidewire lumen can also function to push the filter out of the sheath. The cover tube can cover the main interface between the push and pull components. The hypotube can store the release wire.

[0081] The retrieval catheter assembly can be used to retrieve the embolic protection device and any trapped particles after use. The retrieval catheter assembly can be advanced toward the embolic protection device, and the embolic protection device can be pulled into the retrieval catheter assembly. The retrieval catheter assembly and embolic protection device can then be removed from the body together.

[0082] The retrieval catheter assembly can include a distal opening, a sheath and cover tube, one or more marker bands, and a proximal shaft. The distal opening can include a circular opening having an inner diameter that is larger than the inner diameter of the sheath to minimize or avoid wear of the filter braid during the retrieval process. The sheath and cover tube can include a tubular member within which the folded embolic protection device can be stored during retrieval. One or more marker bands can be connected to the sheath and cover tube at various locations to help visualize when the embolic protection device is fully within the sheath. The proximal shaft can be used to connect the sheath to a structural wire that forms the remaining length of the retrieval catheter assembly.

[0083] Specific exemplary embodiments are further described below. However, it should be understood that any features from any embodiment can be mixed and matched with each other in any combination. Therefore, the present disclosure should not be limited to these embodiments, but any broader combination thereof.

[0084] Figure 1-2 An exemplary embodiment of an embolic protection system 100 including an embolic protection device 110 is shown.

[0085] Figure 1 The embolic protection device 110 is shown in a radially expanded configuration. In the radially expanded configuration, the filter 111 can be radially expanded into an expanded shape. In some embodiments, the radially expanded configuration can be used when the filter 111 is deployed to capture displaced particles. In the exemplary embodiment shown in the figures, the expanded shape can include a substantially conical shape. However, it should be understood that other shapes can be utilized. It should be further understood that, based on the axial and / or rotational movement of the filter 111, the overall shape of the filter 111 can change during use to accommodate different situations, vessels, locations, etc.

[0086] Figure 2A side view of the embolic protection device 110 is shown in a radially compressed configuration. In some embodiments, in the radially compressed configuration, the filter 111 can be radially compressed into a substantially linear or tubular shape as shown. In this radially compressed configuration, the filter 111 is sized and shaped to fit within a tubular sheath 132 of a catheter. The radially compressed configuration can be used when the filter 111 is to be delivered to and / or recovered from a target location in a patient. For example, the radially compressed configuration can be used to install the filter 111 within a delivery catheter 130 for delivery to the target location and, after use, install the filter 111 along with any captured displaced particles within a retrieval catheter 140 (not shown) for recovery from the target location.

[0087] Continue to refer Figure 1-2 In some embodiments, the embolic protection device 110 can include an elongated member, such as a guidewire 120. Although the term "guidewire" is used herein in association with an elongated member, it should be understood that various other types of elongated members can also be used in conjunction with the embolic protection device 110.

[0088] In some embodiments, the guidewire 120 can be integrated with the embolic protection device 110 to facilitate the use of the embolic protection system 100 during medical procedures. Previously, embolic shields and the like required a separate guidewire to be advanced to a target location within the patient's body. Figure 1 The illustrated integrated guidewire 120 , exemplary embodiment, may eliminate the need for such additional devices, thereby increasing the efficiency of use of the embolic protection system 100 .

[0089] like Figure 1-2 , the guidewire 120 may include a proximal portion 121 extending outwardly from the filter 111 in a proximal direction and a distal portion 122 extending outwardly from the filter 111 in a distal direction. In some exemplary embodiments described below, the proximal portion 121 and the distal portion 122 may include separate elongated members that may be interconnected to form a single, unitary guidewire 120. In various embodiments, the lengths of the respective proximal portion 121 and distal portion 122 may vary relative to the overall length of the guidewire 120 and, therefore, should not be construed as limited by the exemplary embodiments shown in the accompanying drawings.

[0090] In some embodiments, to aid in visualization, the distal portion 122 can include a marker 123 comprised of a radiopaque material. The marker 123 can include various configurations, including, for example, a wire wrapped around at least a portion of the distal portion 122. The type of radiopaque material forming such a marker 123 can vary and can include, for example, platinum. In this manner, the distal end 122 of the guidewire 120 can be visualized by various imaging devices known in the art, thereby facilitating tracking as the guidewire 120 is navigated to a target location within the patient's body. In some embodiments, the proximal portion 121 can alternatively or additionally include a marker 123 comprised of a radiopaque material.

[0091] exist Figure 1-2 In the exemplary embodiment shown, it can be seen that the marker 123 can include a wire wrapped around the proximal portion 121 of the guidewire 120 to form a coil marker. However, various other configurations can be utilized in different embodiments. For example, the marker 123 can instead include a marker band that is positioned radially around the proximal portion 121 and / or the distal portion 122 of the guidewire 120. As another example, the proximal portion 121 and / or the distal portion 122 of the guidewire 120 can themselves be at least partially formed of a radiopaque material.

[0092] Figure 3 is a side view of an exemplary embodiment of an embolic protection device 110 in a radially expanded configuration, the embolic protection device 110 comprising a filter 111 movably connected to an elongated member, such as a guidewire 120. As indicated by directional arrow D1, the filter 111 can be adjustably moved along a longitudinal axis such that the filter 111 can be axially moved relative to the underlying guidewire 120. Alternatively or additionally, the filter 1111 can be adjustably moved to rotate about the longitudinal axis such that the filter 111 can be rotated relative to the underlying guidewire 120. Although Figure 3 The filter 111 is shown exhibiting both axial and rotational movement, but it should be understood that in some embodiments, the filter 111 may only move axially or rotationally, but not both.

[0093] The manner in which the filter 111 is removably connected to the guidewire 120 may vary in different embodiments. Figure 3 In the exemplary embodiment shown, the filter 111 can be seen attached directly to a pair of clamps 115A, 115B, with one or both clamps 115A and 115B being movably connected (rotationally and / or axially) to the guidewire 120. In some embodiments, the clamps 115A, 115B can include various types of connectors and, therefore, should not be construed as limited in scope to cylindrical, capped tubular members as shown in the exemplary embodiment of the figures.

[0094] In such Figure 3-5 In the exemplary embodiment shown, a first clamp 115A can be connected to the proximal end of the filter 111, and a second clamp 115B can be connected to the distal end of the filter 111. In some embodiments, the clamps 115A and 115B can each include an internal opening through which the guide wire 120 extends. In some embodiments, each of the clamps 115A and 115B can freely move axially along the longitudinal axis toward or away from each other. Additionally, or alternatively, in some embodiments, each clamp 115A and 115B can freely rotate around the guide wire 120.

[0095] like Figure 3 As best shown in FIG, in some embodiments, a filter stopper 116 can be coupled to the guidewire 120 between the proximal clamp 115A and the distal clamp 115B. In some embodiments, the filter stopper 116 can include a tubular member that is secured to the guidewire 120 between the clamps 115A, 115B. The filter stopper 116 can be used to set a minimum distance between the clamps 115A, 115B such that axial movement of the filter 111 along the guidewire 120 is limited to a set range. Thus, the filter stopper 116 can be used to prevent the clamps 115A, 115B from coming together, thereby setting a minimum length to which the filter 111 can be compressed along its axial direction.

[0096] Figure 3 The exemplary embodiment of the present invention illustrates that the length of filter stop 116 can be greater than half the length of filter 111. However, it should be understood that the length of filter stop 116 can vary in different embodiments and should not be construed as limited to the exemplary embodiment shown in the accompanying drawings. For example, filter stop 116 can be longer or shorter than shown in the drawings. Furthermore, while the accompanying drawings illustrate that filter stop 116 can be primarily located below the mesh portion of filter 111, alternative configurations can be used in different embodiments.

[0097] Continue to refer Figure 3 In some embodiments, the tubular member 117 can be positioned over at least a portion of the guidewire 120 to increase stiffness and transition from a higher stiffness segment of the filter 111 to a lower stiffness segment of the guidewire 120. The tubular member 117 can at least partially cover, be adjacent to, and / or be attached to the distal clamp 115B such that the tubular member 117 covers at least a portion of the distal portion 122 of the guidewire 121, as shown. Figure 3 However, in some embodiments, the tubular member 117 can alternatively or additionally be positioned overlying or adjacent to the proximal clamp 115A.

[0098] Figure 3 An exemplary embodiment is shown in which the tubular member 117 is positioned around the guide wire 120 and adjacent to the distal clamp 115B, but in some of the examples described above, the tubular member 117 can be positioned around the guide wire 20 in addition or alternatively and adjacent to the proximal clamp 115A. In some embodiments, the tubular member 117 can be directly attached to the proximal clamp 115A and / or the distal clamp 115B. In other embodiments, the tubular member 117 can be directly attached to the guide wire 120 adjacent to the proximal clamp 115 and / or the distal clamp 115B. The tubular member 117 can be made of various materials, including but not limited to polymeric materials or thermoplastic elastomers, such as polyether block amide (PEBAX). The length of the tubular member 117 can be different in different embodiments and therefore should not be interpreted as being limited to the exemplary embodiments shown in the drawings.

[0099] Figure 4-5 An exemplary embodiment of a filter 111 for use with the embolic protection device 110 is shown. Figure 4 is a first perspective view of a filter 111 used with the embolic protection device 110 in a deployed configuration. Figure 5 is a second perspective view of a filter in use with the embolic protection device in a deployed configuration.

[0100] Figure 4-5 115B. The filter 111 is shown in a radially expanded configuration. It should be understood that the overall conical shape of the filter 111 shown in the figures may vary in different embodiments and should not be construed as limiting in scope. For example, the shape of the filter 111 may vary based on any axial and / or rotational movement of the filter 111 relative to the guidewire 120 (not shown), with the effective width or diameter of the filter 111 increasing or decreasing based on the distance between the clamps 115A, 115B.

[0101] like Figure 4-5 As shown, in some embodiments, the filter 111 can include a frame 112. The frame 112 can be formed from one or more structural wires that can be manipulated and heat-set into a desired shape, such as the substantially conical shape shown in the figure. Various types of structural wires can be used to form the frame.

[0102] In an exemplary embodiment, the structural wire forming the frame 112 can be composed of drawn filler tubing (DFT) wire or other wire formed at least in part from a radiopaque material. The use of DFT wire for the frame 112 can eliminate the need for separate radiopaque markers on the frame 112. However, in some embodiments, non-radiopaque structural wire can form the frame 112, and separate radiopaque markers can be attached to various portions of the frame 112.

[0103] refer to Figure 4-5 , it can be seen that an exemplary embodiment of the filter 111 can include a braid 113 connected to the frame 112. In some embodiments, the braid 113 can include a mesh braid as shown, or other configurations can be used. The braid 113 can be used to capture any displaced particles within the lumen of the filter 111 for recovery.

[0104] In the exemplary embodiment shown in the figures, it can be seen that braid 113 can cover more than half the length of filter 111. This configuration should not be construed as limiting in scope. In some embodiments, braid 113 can cover less than half the length of filter 111. For example, in various embodiments, braid 113 can cover 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of filter 111.

[0105] In the exemplary embodiment shown in the figures, it can be seen that approximately 40% of the filter 111 is not covered by the braid 113. In this way, the frame 112 can remain exposed to allow any displaced particles to enter the filter 111 and be captured within the braid 113. In one exemplary embodiment, the braid 113 can be positioned to cover the distal portion of the frame 112 of the filter 111. However, in some embodiments, the opposite configuration can be utilized.

[0106] In one exemplary embodiment, the frame 112 can be composed of approximately 16 structural DFT wires having a diameter of approximately 0.0030 inches. In some embodiments, the braid 113 can be composed of approximately 88 smaller 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 in scope. More or fewer wires can be used to form the frame 112 and / or braid 113. Wires of different sizes can also be used to form the frame 112 and / or braid 113. In addition, different materials other than DFT and Nitinol can be used to form the frame 112 and braid 113, respectively.

[0107] The manner in which braid 113 is secured to frame 112 may vary in different embodiments. Various methods known in the art for securing braid 113 to frame 112 may be utilized, such as, but not limited to, welding. Frame 112 and / or braid 113 may also be treated with an anti-clotting surface treatment or coating to help reduce clot formation when filter 111 is in use.

[0108] Figure 6-8An exemplary embodiment of a delivery catheter 130 that can be used to deliver the embolic protection device 110 including the filter 111 to a target location within the body is shown, with the proximal portion on the left side of the figure and the distal portion on the right side of the figure. Figure 6 A side view of an exemplary embodiment of a delivery catheter 130 including interconnected push-pull assemblies 131 , 136 is shown. Figure 7 A side view of an exemplary embodiment of the pulling assembly 131 of the delivery catheter 130 is shown. Figure 8 A side view of an exemplary embodiment of the pusher assembly 136 of the delivery catheter 130 is shown.

[0109] like Figure 6-7 As best shown, the delivery catheter 130 can include a pulling assembly 131 that can 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 pulling assembly 131 can include a sheath 132, a distal shaft 134, and a release wire 135.

[0110] In some embodiments, the embolic protection device 110, including the filter 111, can be contained in a radially compressed configuration within a sheath 132 of a delivery catheter 130 during delivery to a target location within a patient. In some embodiments, the sheath 132 can include a tubular member, such as Figure 7 As shown. The length and width of the sheath 132 can vary in different embodiments to accommodate different embodiments of the filter 111. In some embodiments, the sheath 132 can include a marker band 133 at or near its proximal end. The marker band 133 can be composed of a radiopaque material that aids in visualization and indicates when the filter 111 is fully within the sheath 132.

[0111] In some embodiments, distal shaft 134 can include a solid or tubular elongated member connected between sheath 132 and release wire 135. Typically, in some embodiments, filter 111 does not enter distal shaft 134, but is merely positioned within sheath 132 during delivery. In some embodiments, release wire 135 can be secured to the proximal end of distal shaft 134. Pulling release wire 135 can be used to retract sheath 132 from around filter 111, thereby deploying filter 111.

[0112] like Figure 6 and Figure 8As best shown, the delivery catheter 130 can include a push assembly 136 that can assist in delivering the filter 111 by pushing the filter 111 out of the sheath 132 of the pull assembly 131 as the sheath 132 is retracted. In some embodiments, the push assembly 136 can include a guidewire lumen 137, a cover tube 138, and a hypotube 139, as shown. Figure 8 As shown, the pulling assembly 131 and the pushing assembly 136 can both move axially independently of each other.

[0113] refer to Figure 8 , it can be seen that the guidewire lumen 137 can serve a dual purpose, namely, acting as a hard stop for the filter 111 within the sheath 132 and pushing the filter 111 out of the sheath 132 as the sheath 132 is retracted to deploy the filter 111. In some embodiments, the cover tube 138 can include a tubular member that covers the primary interface between the interconnected push-pull assemblies 131, 136, as shown. Figure 6 In some embodiments, a hypotube 139 can be used to house the release wire 135 and can be bonded within the proximal end of the cover tube 138. A guidewire lumen 137 can be similarly secured within the cover tube 138 while extending distally therefrom.

[0114] Figure 9 1 shows a side view of an exemplary embodiment of a retrieval catheter 140 that can be used to retrieve the embolic protection device 110 and any captured particles within the filter 111 from a target location within the body after a medical procedure is completed. Figure 9 As shown, an exemplary embodiment of a retrieval catheter 140 can include a distal opening 141, a sheath 142, one or more marker bands 142A, 142B, and a proximal shaft 143. The retrieval catheter 140 can include a retrieval sheath 142 for receiving the filter 111.

[0115] In some embodiments, the sheath 142 can include a tubular member sized to mount the filter 111 therein when in a radially folded configuration. In some embodiments, the sheath 142 can include a distal opening 141 at its distal end. The inner diameter of the distal opening 141 can be larger than the inner diameter of the sheath 142 to minimize wear on the filter 111 during removal.

[0116] refer to Figure 9One or more marker bands 142A, 142B composed of a radiopaque material can be at least partially attached around the sheath 142 to aid in visualization. For example, one or more marker bands 142A, 142B can help the operator visualize when the filter 111 is fully positioned within the retrieval sheath 142. The number of marker bands 142A, 142B varies in different embodiments and should not be construed as limiting the scope of the exemplary embodiments shown in the figures. For example, more or fewer than the two marker bands 142A, 142B shown in the figures may be used.

[0117] Continue to refer Figure 9 As can be seen, in an exemplary embodiment, the retrieval sheath 142 can 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 can be located at or near the distal end of the sheath 142, proximate to the distal opening 141. In some embodiments, the first marker band 142A can be axially spaced apart from the second marker band 142B toward the proximal end of the retrieval sheath 142. The distance between the marker bands 142A, 142B can vary, but can generally be approximately equal to the length of the filter 111 in the radially compressed configuration.

[0118] In some embodiments, the proximal shaft 143 can be coupled within the proximal end of the retrieval sheath 142 and extend proximally therefrom, such as Figure 9 The proximal shaft 143 can be used to connect the sheath 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 sheath 142, proximal shaft 143, and retrieval catheter 140 can vary overall in different embodiments to accommodate different applications.

[0119] Figure 10 A close-up view of the frame 112 and braid 113 portions of the embolic protection device 110 is shown. In some exemplary embodiments, Figure 4-5 As shown in Figures 10, all or a portion of the frame 112 can be formed from one or more pairs of paired structural wires 112A. In other words, some or all of the structural wires forming the frame can include a pair of wires 112A that converge or fuse together to increase structural integrity. Such paired structural wires 112A can provide structural support for the filter 111 in either an expanded or folded configuration.

[0120] The paired structural wires 112A can be adjusted between at least a folded configuration and an expanded configuration. In the folded configuration, the paired structural wires 112A can be folded or compressed into a substantially cylindrical shape for installation within a delivery device. In the expanded configuration, the paired structural wires 112A can be expanded into various shapes, including but not limited to Figure 4-5 and Figure 10 As shown in the shape, the outer profile of the unfolded paired structural wires 112A may have a central portion with a larger diameter that tapers in diameter toward its proximal and distal portions, such that the center is convex.

[0121] Pairs of structural wires 112A may extend between a proximal clamp 115A and a distal clamp 115B, with the proximal pair of structural wires 112A of the frame 112 being tightened or otherwise secured to the proximal clamp 115A and the distal pair of structural wires 112A of the frame 112 being tightened or otherwise secured to the distal clamp 115B.

[0122] Filter 111 can be fixed to and / or fixed by paired structural wire 112A.As shown, paired structural wire 112A can be positioned along the outer surface of filter 111, or in some embodiments, also can extend through or across the inner area of ​​filter 111.Paired structural wire 112A can contact one or more areas of the outer surface of filter 111.Frame 112 can be unfolded and / or folded according to filter 111.The unfolding and / or folding of filter 111 can be used to also unfold and / or fold frame 112 and / or the unfolding and / or folding of frame 112 can also be used to unfold and / or fold filter 111.

[0123] Although not shown, in some embodiments, three or more wires can be paired together in a similar manner to form the structural wires of the frame 112. Using this configuration for the structural wires can aid in visibility and provide structural integrity to the filter 111.

[0124] Figure 11 A side view of another exemplary embodiment of an embolic protection device 110 is shown, comprising a filter 111, a frame 112 to which the filter 111 is attached, a proximal clamp 115A, and a distal clamp 115B. As shown, in some embodiments, a tubular member 117 can 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, but as previously described, other configurations can be used in different embodiments.

[0125] Continue to refer Figure 11 In some embodiments, it can be seen that the tubular member 117 can comprise an elongated cylindrical tubular member. The length of the tubular member 117 can vary. Thus, Figure 11 The relative length of the tubular member 117 shown in FIG. 1 relative to the remaining length of the embolic protection device 110 (eg, the frame 112 ) should not be construed as limiting in scope. In an exemplary embodiment, the total length of the tubular member 117 can comprise approximately 10 mm.

[0126] Since the tubular member 117 forms the leading edge of the embolic protection device 110 during delivery, it may be desirable for at least a portion of the tubular member 117 to be flexible or semi-flexible to aid in navigating tortuous anatomical structures and to gradually transition from a higher stiffness to a lower stiffness. This configuration can achieve a smoother bend transition between the distal guidewire tip and the folded filter within the delivery catheter sheath. This configuration also helps fill the space between the guidewire 120 and the distal tip of the delivery catheter 130, as shown in FIG. Figure 2 Therefore, Figure 11 As shown, the elongated tubular member forming the tubular member 117 may include a variable stiffness or hardness along its length, with the stiffness or hardness along the distal portion of the tubular member 117 being less than the stiffness or hardness along the proximal portion of the tubular member 117 .

[0127] In one exemplary embodiment, a first portion 117A of the length of the tubular member 117 can include a first hardness or stiffness, while a second portion 117B of the length of the tubular member 117 can include a second hardness or stiffness. The first portion 117A can include a proximal portion and the second portion 117B can include a distal portion, wherein the hardness or stiffness of the first proximal portion 117A is greater than the hardness or stiffness of the second distal portion 117B. However, in some embodiments, the opposite configuration can be utilized.

[0128] Although Figure 11 It is shown that the first proximal portion 117A can comprise a first half of the length of the tubular member 117 and the second distal portion 117B can comprise a second half of the length of the tubular member 117, but it should be understood that different ratios of the lengths of the respective portions 117A, 117B can be used. In one exemplary embodiment, the tubular member 117 can comprise a length of approximately 10 mm, the first proximal portion 117A can comprise a length of approximately 5 mm, and the second distal portion 117B can comprise a length of approximately 5 mm.

[0129] The first and second portions 117A, 117B of the tubular member 117 may comprise the same material but have different stiffnesses or hardnesses, or they may comprise different materials having different stiffnesses or hardnesses that are fused or joined together using various methods known in the art. For example, the first portion 117A of the tubular member 117 may be comprised of a thermoplastic elastomer or other polymeric material, such as a polyether block amide (e.g., PEBAX 53D) having a first hardness, and the second portion 117B of the tubular member may be comprised of a thermoplastic elastomer or other polymeric material, such as a polyether block amide (e.g., PEBAX 35D) having a second hardness.

[0130] exist Figure 11 In the exemplary embodiment shown, it can be seen that the first portion 117A and the second portion 117B can each have adjacent, angled (e.g., beveled or angled) cuts. However, it should be understood that in some exemplary embodiments, the connection between the first portion 117A and the second portion 117B can be linear or perpendicular (e.g., "butt bonding").

[0131] Figure 12A 、 12B , 12C and 12D illustrate exemplary embodiments of a one-handed deployment handle 150 for use with the delivery catheter 130. Figure 12A An upper perspective view of the deployment handle 150 of the embolic protection system 100 is shown in an undeployed configuration. Figure 12B An upper perspective view of the deployment handle 150 of the embolic protection system 100 is shown in a deployed configuration. Figure 12C A side view of the deployment handle 150 of the embolic protection system 100 is shown in an unlocked configuration. Figure 12D A top view of the deployment handle 150 of the embolic protection system 100 is shown in a locked configuration.

[0132] In the past, such handles used with delivery catheters required two hands to operate. Figures 12A-12D In the exemplary embodiment shown, the embolic protection device 110 can be deployed from the delivery catheter 130 using a single-handed operation, thereby freeing the operator's other hand.

[0133] like Figures 12A-12B As shown, the deployment handle 150 can include a substantially elongated configuration with an ergonomic design. In some embodiments, the deployment handle 150 can include a proximal end 150B configured to be grasped by a single hand of an operator and a distal end 150A from which the release wire 135 of the delivery catheter 130 can extend. Therefore, it should be understood that the distal end 150A of the deployment handle 150 can include a lumen through which the release wire 135 can be inserted and secured to the trigger 152, as described in more detail below.

[0134] Continue to refer Figures 12A-12B In some embodiments, the deployment handle 150 can include a slot 151 extending along at least a portion of the length of its elongated body. While the figures illustrate the slot 151 extending along the top of the deployment handle 150, it should be understood that other configurations are possible (e.g., the slot 151 can instead extend along either side or the bottom of the deployment handle 150).

[0135] It should also be understood that the length of the slot 151 can vary in different embodiments, and thus the range should not be construed as limited to the width of the slot 151 shown in the exemplary embodiments shown in the drawings. In different embodiments, the ratio of the length of the slot 151 relative to the overall length of the deployment handle 150 can vary.

[0136] like Figures 12A-12B As further shown, in some embodiments, the trigger 152 can be movably or slidably coupled within the slot 151 such that the trigger 152 can freely move in either direction (proximally or distally) along at least a portion of the length of the slot 151. The trigger 152 can include ergonomic features to facilitate gripping the trigger 152 with one finger. The release wire 135 of the delivery catheter 130 can be attached or coupled (directly or indirectly) to the trigger 152 such that movement of the trigger 152 in the proximal direction pulls the release wire 135 and movement of the trigger 152 in the distal direction pushes the release wire 135.

[0137] In some embodiments, the deployment handle 150 can be grasped by one hand (or two hands), for example at or near its proximal end 150B, and the trigger 152 can be retracted proximally using one or more fingers or thumbs to pull the release wire 135, thereby exposing and deploying the embolic protection device 110. Figure 12A An upper perspective view of deployment handle 150 and trigger 152 is shown in an undeployed configuration. Figure 12B An upper perspective view of the deployment handle 150 and trigger 152 is shown in a deployed configuration.

[0138] Go to Figures 12C-12D In some embodiments, the deployment handle 150 can include a locking mechanism 155 operable to lock the trigger 152 in an undeployed configuration, thereby preventing premature deployment of the embolic protection device 110. In some embodiments, the locking mechanism 155 can include a tab or other structural component that can be positioned in a manner such as Figure 12C The unlocked configuration shown and Figure 12D The locking configurations shown are hinged or otherwise adjustable.

[0139] like Figure 12C As shown, when in the unlocked configuration, the locking mechanism 155 is adjusted away from and away from the path of the trigger 152 along the slot 151. Figure 12D As shown, when in the locked configuration, locking mechanism 155 is adjusted to span or cover a proximal portion of slot 151 relative to trigger 152 when trigger 152 is in the deployed configuration, thereby preventing trigger 152 from moving proximally along slot 151.

[0140] Figure 13AA perspective view of the retrieval catheter 140 positioned for removing the embolic protection device of the embolic protection system 100 is shown. Figure 13B FIG. 1 shows a perspective view of the embolic protection device 110 being retrieved by the retrieval catheter 140 of the embolic protection system 100 according to an exemplary embodiment of the present invention. Figures 13A-13B As shown, the distal opening 141 may include an inner bevel 141A to prevent or reduce wear of the filter 111 when entering the distal opening 141. The inner bevel 141A may include an inwardly tapered end of the distal opening 141.

[0141] Figure 14 A side view of an adjustment handle 165 is shown 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 tip of the retrieval catheter 140 to improve navigation and facilitate positioning of the retrieval catheter 140 for retrieving the embolic protection device 110.

[0142] refer to Figure 14 In some embodiments, the adjustment handle 165 can be composed of a flexible or semi-flexible material to allow adjustment between a compressed configuration and an uncompressed configuration. In some embodiments, the adjustment handle 165 can also be composed of an elastic material so that the adjustment handle 165 naturally returns to its original shape (e.g., its uncompressed configuration) when no force is applied. In some exemplary embodiments, the adjustment handle 165 can function similar to a leaf spring.

[0143] In some embodiments, the adjustment handle 165 may include a generally pear-shaped configuration with an internal opening such that the adjustment handle 165 may be compressed inwardly. Figure 14 As shown, in some embodiments, the adjustment handle 165 can further include a lumen extending through its length, within which the proximal shaft 143 of the retrieval catheter 140 can be positioned.

[0144] The proximal shaft 143 can be anchored within the adjustment handle 165 such that compression of the adjustment handle 165 (causing the adjustment handle 165 to extend into its compressed configuration) can operate to pull the proximal shaft 43, thereby deflecting the distal opening 141 of the retrieval catheter 140, as shown. Figure 14 Thus, in use, an operator can compress the adjustment handle 165 with one hand to deflect the distal opening 141 of the retrieval catheter 140 , thereby providing better navigability when positioning the distal opening 141 for retrieval of the embolic protection device 110 .

[0145] Figure 15A side view of an irrigation system for flushing a retrieval catheter 140 is shown, for example, while the retrieval catheter 140 is still in its manufacturer's packaging. In the past, doctors or other practitioners were forced to flush the catheter 140 after removing it from its packaging. Often, this flushing process can be complicated if the doctor or other practitioner's hands are shaky or nervous. By flushing the retrieval catheter 140 before removing it from its original packaging, the retrieval catheter 140 can be anchored or secured during the flushing process, so that any nervousness or hand tremors will not affect the flushing process.

[0146] like Figure 15 As shown, the flushing system may include a syringe 160 that stores a volume of fluid. Syringe 160 can be in fluid communication with tubing 161, which itself can be in fluid communication with retrieval catheter 140. In some exemplary embodiments, syringe 160 can be connected directly to retrieval catheter 140 for flushing without requiring any additional tubing 161. In some embodiments, tubing 161 can comprise PVC tubing. The distal end of retrieval catheter 140 is shown connected to packaging coiled tubing 162, just as it was in the original packaging.

[0147] In use, before removing the retrieval catheter 140 from its original packaging or removing the packaging coiled tubing 162, a fluid (e.g., saline) can be introduced into and expelled from the syringe 160 to flush the retrieval catheter 140. The syringe 160 can be connected to a Luer connector or other port at one end of a flexible tubing 161 that is in fluid communication with the retrieval catheter 140. The plunger of the syringe 160 can then be advanced to expel the fluid through the tubing 161 and the retrieval catheter 140, thereby flushing the retrieval catheter 140. The retrieval catheter 140 can then be removed from its original packaging and set aside for use.

[0148] In use, the embolic protection device 110 can first be delivered to a target location within a blood vessel. Typically, the embolic protection device 110 can be delivered to a location remote from where a medical procedure is to be performed (e.g., but not limited to, stenting, angioplasty, or any other procedure with a risk of particle displacement). Example methods for the delivery and deployment of embolic protection devices are disclosed in U.S. Patent No. 11,166,804, the entire contents of which are incorporated herein by reference.

[0149] The embolic protection device 110 including the filter 111 can be delivered to the target site via a delivery catheter 130. In some embodiments, the filter 111 can be compressed into its radially compressed configuration and stored entirely within the sheath 132 of the delivery catheter 130. The delivery catheter 130 can then be guided to the target site by various methods known in the art.

[0150] After reaching the target location, in some embodiments, the release wire 135 of the pull assembly 131 of the delivery catheter 130 can be pulled to retract the sheath 132 from around the filter 111. While performing this step, the push assembly 136 of the delivery catheter 130 can also be used to push the filter 111 out of the sheath 132. Due to the configuration of the delivery catheter 130, including the use of the pull and push assemblies 131, 136, the filter 111 can be deployed without shifting position within the blood vessel, thereby reducing the tendency of the filter 111 to slide out of position during deployment.

[0151] After deploying the filter 111, in some embodiments, the filter 111 can be generally deployed distally to its radially expanded configuration relative to the location where the medical procedure is being performed. The delivery catheter 130 can be removed. Any particles that may be displaced during the medical procedure can enter the frame 112 of the filter 111 and be captured by the braid 113, thereby preventing various complications caused by these displaced particles.

[0152] After the medical procedure is completed, in some embodiments, the filter 111 can be removed from the patient using a retrieval catheter 140. The retrieval catheter 140 can be advanced to the embolic protection device 110, and the filter 111 can be pulled into its sheath 142 through the distal opening 141 of the retrieval catheter 140. The wider inner diameter of the distal opening 141 compared to the sheath 142 can prevent abrasion of the filter 111 during the retrieval process. The filter 111 will fold into its radially compressed configuration upon entering the sheath 142. Marker bands 142A, 142B can be used to visualize when the filter 111 is fully positioned within the sheath 142, after which the retrieval catheter 140 can be removed from the patient.

[0153] Figures 16A-16C An example of a proximal region of a delivery catheter 130 is shown, wherein a guidewire 146 may be constrained within a lumen (e.g., first lumen 144a or second lumen 144b) of the delivery catheter 130. The delivery catheter 130 may include multiple lumens, such as a double lumen catheter ( Figure 16B ) or a triple lumen catheter (not shown). Figure 16AThe proximal region of a delivery catheter 130 having multiple lumens is shown. As shown, a guidewire 146 can be contained within a first lumen (e.g., 144a) of the delivery catheter 130, which can leave the second lumen 144b (or the third lumen 144c in a triple-lumen catheter, not shown) available as an additional working lumen. In an exemplary embodiment, the embolic protection device 110 can be navigated to the anatomical target through the second lumen 144b. Using a multi-lumen catheter can allow an 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 will be isolated from the components in the second lumen 144b, avoiding entanglement, interference, and / or other undesirable interactions.

[0154] Figure 16B Shown Figure 16A 14. Cross-section BB of the delivery catheter 130. As shown, in some embodiments, the delivery catheter 130 can include a first lumen 144a and a second lumen 144b. In some embodiments, the diameters of the first lumen 144a and the second lumen 144b can be the same or different. In one embodiment, the diameter of the first lumen 144a can be greater than the diameter of the second lumen 144b. In some embodiments, the diameter of the first lumen 144a can be less than the diameter of the second lumen 144b. In the example shown, the guidewire 146 can be constrained within the first lumen 144a. In some embodiments, the second lumen 144b of the delivery catheter 130 can be configured to accommodate the embolic protection device 110, wherein the embolic protection device 110 can be navigated via the second lumen 44b to the target location where the medical procedure is to be performed.

[0155] Figure 16C Shown Figure 16A The cross section CC of the delivery conduit 130 is as follows. Figure 16C As shown, in some embodiments, the proximal region of the delivery catheter 130 may also include a slit 170 ( Figure 16C ). For example, Figure 16A and 16C As shown, slit 170 can be located between first lumen 144a and the outer surface of delivery catheter 130 and extend from the proximal tip of delivery catheter 130 to the distal region of delivery catheter 130, a length L1. In some embodiments, slit 170 can begin at the proximal tip and extend distally to a location near the hemostasis valve. In some embodiments, slit 170 can extend all the way through the double-lumen tubing to the RX port distal to the hemostasis valve. When the user pulls out delivery catheter 130, it may peel away from guidewire 146.

[0156] In some embodiments, the slit 170 can separate the guidewire 146 and the proximal end of the guidewire handle from the delivery catheter by a distance D1, which can improve operational convenience by providing the operator with sufficient working space to navigate the embolic protection device 110 through the second lumen 144b to the target location. In one example, the length L1 of the slit 170 is approximately 10 cm, 20 cm, 30 cm, 40 cm, or 50 cm.

[0157] Figure 17 An example of the distal end 121 of the guidewire 120 of the embolic protection device 110 described above is shown. In some embodiments, the distal end 121 can include a core wire 180 having one or more coils 186 affixed thereto. In the illustrated example, the core wire 180 can include one or more reduced diameter regions 182 and / or one or more bulbous regions 184. In some embodiments, the diameter of the one or more bulbous regions 184 can be larger than that of the reduced diameter region 182 and can taper in the proximal and / or distal directions. In some embodiments, the core wire 180 can be flattened (e.g., having a rectangular cross-section), which can enhance the bendability of the core wire 180. In some embodiments, the flattened core wire 180 can enhance vascular access by effectively transferring torque from the proximal end of the guidewire 120 to the distal tip and can further facilitate better control and trackability during guidewire tracking. In some embodiments, the one or more coils 186 are affixed to a distal portion of the core wire 180, such as its distal end, by various methods known in the art, such as laser welding. In one example, the one or more coils 186 can be constructed from various materials including platinum tungsten. In one example, the distal end 121 of the guidewire 120 can be approximately 60-65 mm in length.

[0158] Terms:

[0159] Exemplary embodiments are listed in the following numbered clauses:

[0160] Clause 1. An embolic protection system comprising an embolic protection device comprising a filter for capturing displaced particles, a delivery catheter for delivering and deploying the embolic protection device, and a retrieval catheter for retrieving the embolic protection device along with any captured particles.

[0161] Clause 2. An embolic protection device comprising an elongated member, such as a guidewire or a corewire, and a filter removably connected to the elongated member.

[0162] Clause 3. The embolic protection device of clause 2, comprising a filter, wherein the filter is axially movable relative to the elongated member.

[0163] Clause 4. The embolic protection device according to clause 2 or 3, comprising a filter, said filter being rotationally movable relative to the elongated member.

[0164] Clause 5. The embolic protection device according to any one of clauses 2-4, comprising one or more clamps movably connected to the elongated member.

[0165] Clause 6. The embolic protection device according to clause 5, wherein the proximal end of the filter is fixed to the first clamp and the distal end of the filter is fixed to the second clamp.

[0166] Clause 7. An embolic protection device according to any of the preceding clauses, comprising applying or coating the filter with an anti-clotting surface treatment.

[0167] Clause 8. An embolic protection device according to any of the preceding clauses, comprising a filter comprising a framework formed from one or more structural wires.

[0168] Clause 9. The embolic protection device according to Clause 8 may include a plurality of structural wires, wherein each structural wire is composed of a pair of DFT wires.

[0169] Clause 10. The embolic protection device according to clauses 8 and / or 9, may comprise a braid connected to the frame.

[0170] Clause 11. The embolic protection device of any of clauses 8-10, comprising a braid connected to the frame to cover at least half of the length of the frame.

[0171] Clause 12. An embolic protection device according to any of the preceding clauses, comprising a filter retainer connected to the inner elongated member of the filter.

[0172] Clause 13. A delivery catheter comprising a pulling assembly for retracting a sheath from around a filter and a pushing assembly for pushing the filter out of the sheath.

[0173] Clause 14. The delivery catheter of clause 13, comprising a pulling assembly comprising a sheath, a marker band, a distal shaft, and / or a release wire.

[0174] Clause 15. The delivery catheter according to clauses 13 and / or 14 may include a push assembly comprising a guidewire lumen, a cover tube, and a hypotube.

[0175] Clause 16. A method of delivering an embolic protection device, comprising positioning a filter within a sheath while the filter is in a radially folded or compressed configuration, delivering the sheath to a target location, and retracting the sheath from around the filter to expose and deploy the filter in a radially expanded configuration.

[0176] Clause 17. The method of clause 16, comprising pushing the filter out of the sheath.

[0177] Clause 18. A method of delivering an embolic protection device, comprising placing a filter within a delivery catheter, delivering the delivery catheter to a target blood vessel, and deploying the embolic protection device from the delivery catheter.

[0178] Clause 19. The method of clause 18, comprising retracting the delivery catheter from around the embolic protection device using a pulling assembly.

[0179] Clause 20. The method of clauses 18 and / or 19, comprising using a push assembly to push the embolic protection device out of the delivery catheter.

[0180] Clause 21. The method of any of clauses 18-20, comprising deploying the embolic protection device at a location remote from the location where the medical procedure is to be performed.

[0181] Clause 22. A method of capturing one or more displaced particles, comprising delivering and deploying a filter within a blood vessel to capture any one of the one or more displaced particles.

[0182] Clause 23. The method of clause 22, comprising deploying the filter into a radially deployed configuration and adjusting the radially deployed configuration by moving the filter axially and / or rotationally relative to an underlying guidewire.

[0183] Clause 24. A method of retrieving a filter and any captured particles, comprising delivering a retrieval catheter to a target location, positioning a filter within the retrieval catheter, and retrieving the retrieval catheter from a patient.

[0184] Clause 25. The method of clause 24, comprising advancing the retrieval catheter over the filter.

[0185] Although the present disclosure has been described in terms of specific embodiments and applications, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the present disclosure and should not be construed as limiting its scope.

Claims

1. An embolic protection device, comprising: slender parts; a first clamp movably connected to the elongated member; and a filter comprising a woven mesh; wherein the filter is adjustable between a radially compressed configuration and a radially expanded configuration; and, The filter is coupled to the first fixture such that the filter is movable relative to the elongated member when the filter is in the radially expanded configuration.

2. The embolic protection device of claim 1, further comprising a second clamp connected to the elongated member, and wherein the proximal end of the filter is connected to the second clamp. 3 . The embolic protection device of claim 2 , wherein the second clamp is movably connected to the elongated member. 4 . The embolic protection device of claim 3 , wherein a distal end of the filter is connected to the first clamp, and wherein a proximal end of the filter is connected to the second clamp. The embolic protection device of claim 1 , wherein the braided mesh covers at least half of the length of the filter.

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

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

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

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 are composed of a plurality of drawn filler tubing (DFT) wires.

12. The embolic protection device of claim 1, further comprising a stopper coupled to the elongated member for limiting movement of the filter relative to the elongated member.

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

14. The embolic protection device of claim 1, further comprising a radiopaque coil located on the distal portion of the elongated member.

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

16. An embolic protection system comprising: A filter assembly, the filter assembly comprising: Guidewire; a filter movably connected to the guidewire such that the filter can move relative to the guidewire; wherein the filter is adjustable between a radially compressed configuration and a radially expanded configuration, wherein when in the radially expanded configuration, the filter comprises a conical shape; and A delivery catheter assembly, comprising: a sheath for storing the filter assembly prior to deployment; and A release wire is connected to the sheath for retracting the sheath from around the filter.

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

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

19. The embolic protection system of claim 18, wherein the retrieval catheter assembly comprises a distal opening, wherein the inner diameter of the distal opening is larger than the inner diameter of the retrieval sheath.

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

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

22. An embolic protection device, comprising: slender parts; a clamping device movably connected to the elongated member; and filtration devices to capture embolic particles; wherein the filtering device is adjustable between a radially compressed configuration and a radially expanded configuration; and, wherein the filter device is connected to the clamping device such that the filter device is radially and rotationally movable relative to the elongated member when the filter device is in the radially expanded configuration.

23. An embolic protection system comprising: a filter comprising a plurality of structural wires and a woven mesh; wherein the filter is adjustable between a radially compressed configuration and a radially expanded configuration, wherein when in the radially expanded configuration, the filter comprises a conical shape; and A tubular member is connected to the filter and extends distally from the filter, the tubular member including a proximal end and a distal end, and wherein the hardness of the proximal end of the tubular member is greater than the hardness of the distal end of the tubular member.

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

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

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

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

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

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

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

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

32. An embolic protection system comprising: a filter adjustable between a folded conformation and an unfolded conformation; A delivery catheter assembly, comprising: a sheath for storing the filter prior to deployment; a release wire connected to the sheath for retracting the sheath from around the filter; and a deployment handle comprising a slot and a trigger movably positioned within the slot, wherein the release wire is connected to the trigger; and, The trigger is adjustable between an undeployed configuration and a deployed configuration.

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 configuration.

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

35. The embolic protection system of claim 33, wherein the trigger is operable to pull the release wire to retract the sheath when the trigger is in the deployed configuration.

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

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

38. An embolic protection system comprising: a filter adjustable between a collapsed configuration and an expanded configuration; and a retrieval catheter for retrieving the filter from a patient, the retrieval catheter comprising a retrieval sheath for receiving the filter; Wherein, the retrieval sheath includes a distal opening, wherein the inner diameter of the distal opening is larger than the inner diameter of the retrieval sheath, and wherein the distal opening includes an inner bevel or an inwardly tapered distal end to prevent the filter from wearing when entering the distal opening.

39. An embolic protection system comprising: a filter adjustable between a collapsed configuration and an expanded configuration; a retrieval catheter for retrieving the filter from a patient, the retrieval catheter comprising a retrieval sheath for receiving the filter and a proximal shaft; an adjustment handle connected to the proximal shaft of the retrieval catheter, wherein the adjustment handle is adjustable between a compressed configuration and an uncompressed configuration; and, Wherein, compressing the adjustment handle to the compressed configuration is operable to deflect the distal end of the retrieval catheter.

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

41. The embolic protection system of claim 39, wherein the adjustment handle is comprised of a flexible or semi-flexible elastic material.

42. A method of flushing a catheter, comprising: Provide the catheter secured in its original packaging; connecting a tube to the catheter; attaching a syringe to the tube, the syringe storing a volume of fluid; as well as The plunger of the syringe is advanced to direct the fluid through the catheter while the catheter remains secured in its original packaging.

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