Embolic protection device

Abstract

The present invention includes an embolic protection device comprising: a catheter having a self-expanding embolic filter disposed about the vicinity of a distal portion of the catheter, where the embolic filter comprises a frame and the frame defines an opening of the embolic filter, the opening facing a distal end of the catheter; a deployment mechanism disposed about at least a portion of the catheter, where the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism configured to contain an embolic filter in a folded configuration, and the embolic filter configured to self-expand upon longitudinal retraction of the deployment mechanism; and a wire coupled to the frame to expand the size or diameter of the embolic filter opening.

Description

[0001] This application is a divisional application of the patent application for "Embolic Protection Device" with an international filing date of March 6, 2019, an international application number of PCT / US2019 / 020952, and a national application number of 201980028897.X.

[0002] Cross - Reference to Related Applications

[0003] This PCT application claims the benefit of U.S. Provisional Application No. 62 / 639,618, filed on March 7, 2018, and U.S. Provisional Application No. 62 / 812,391, filed on March 1, 2019. Each of these documents is hereby incorporated by reference in its entirety into this application. Technical Field

[0004] This application relates to an embolic protection device including a catheter, and a method of using such an embolic protection device in a medical procedure (such as a closed-heart surgical procedure). Background Art

[0005] Conventional pigtail catheters are used in percutaneous cardiac surgical procedures where the positioning of various instruments and devices within the patient's vasculature is important. These pigtail catheters include a curved distal end that can be placed within the patient's anatomy (such as an artery (e.g., the aorta)) and hold the catheter in place while other instruments and devices are delivered into the patient's vasculature. Some conventional pigtail catheters include a lumen and small orifices at their distal ends through which contrast agent can be injected into the patient's vasculature to image relevant portions of the patient's anatomy and identify anatomical landmarks.

[0006] However, the use of traditional pigtail catheters in percutaneous cardiac surgery typically poses a serious life-threatening complication to patients. For example, cerebral embolism is a common complication in cardiac surgeries (such as valve replacement and repair) in which traditional pigtail catheters are deployed. In such surgeries, plaque, calcium, emboli, or any combination thereof in blood vessels, valves, and / or heart chambers can be dislodged by a catheter or other medical device introduced into the patient's vasculature. The dislodged plaque, calcium, emboli, or any combination thereof can be carried by the blood flow from the aorta to the patient's brain and can cause an obstruction therein leading to an embolic event such as a stroke. Approximately 2.9%-6.7% of patients undergoing transcatheter aortic valve implantation (TAVI) via the femoral artery have a stroke within 30 days, and even more (4.5%-10.6%) have a stroke that typically leads to death within one year. Additionally, according to neuroimaging studies, up to 85% of patients treated with TAVI have evidence of cerebral embolism. Although clinically silent, this embolism phenomenon is associated with cognitive decline (Astraci 2011; Ghanem 2010; Kahlert 2010; Rodes-Caban 2011).

[0007] Currently, there are some devices on the market designed to protect the brain, abdominal organs, and carotid arteries from embolism, but these devices are plagued by various significant drawbacks. For example, the Embrella Embolic Deflector® produced by Edwards Lifesciences in Irvine, California, USA, uses a deflection plate to deflect emboli from the carotid artery to the descending aorta, but the device does not intercept emboli, so the emboli can travel freely to other parts of the body and cause harmful complications. The EMBOL-X® also produced by Edwards Lifesciences uses a filter mesh, but the device is designed for open-heart surgery, which poses additional medical risks and increases morbidity. Additionally, using multiple devices, such as a catheter for visualization and a separate filter device, prolongs the surgical time and increases the risk of complications for the patient. Summary of the Invention

[0008] The present invention provides an embolism protection device to meet these and other needs, the embolism protection device including a deployable embolism filter disposed around a catheter, the catheter having a distal portion that can assume an arcuate configuration that is at least semi-circular and having a wire operable to manipulate the embolism filter into a configuration that more fully engages the body cavity.

[0009] The combination of a catheter and an embolic filter in the same device can separately provide the benefits of the two devices and provide a synergistic effect. For example, the integration of a catheter and an embolic filter can reduce the duration of a medical procedure and reduce the occurrence of complications (such as those caused by dislodged emboli). In other examples, the expansion of the embolic filter can help anchor the catheter in place to provide a more precise catheter position than a position where the catheter is vulnerable to blood flow, tissue movement, etc. In a valve replacement procedure, the anchoring of the catheter and the more precise positioning of the catheter can help ensure that the valve prosthesis is correctly positioned and stable. In another example, the position of the catheter can ensure that the filter is correctly positioned.

[0010] In some aspects, the embolic protection device includes a catheter, a self-expanding embolic filter coupled to the catheter, a pull wire for reorienting the filter by bending the filter frame, and an outer sheath movable relative to the embolic filter and the catheter. The outer sheath holds the embolic filter in a collapsed configuration when around the embolic filter and retracts proximally to deploy the embolic filter. The outer sheath can recapture the embolic filter and any debris captured therein by advancing distally. Both the filter and the outer sheath can move relative to the catheter, for example to be able to longitudinally move the embolic filter without having to longitudinally move the entire catheter. The advantage of the pull wire is its ability to bend the frame, thus orienting the filter openings towards the distal end of the device and enabling the embolic filter to more fully engage the body cavity.

[0011] In some aspects, the catheter has a proximal end and a distal end. A lumen extends from the proximal end of the catheter to the distal end of the catheter. In some embodiments, the lumen can be configured to accommodate a guide wire.

[0012] In certain aspects, the catheter is a pigtail catheter. The pigtail catheter is configured to curl at the distal end of the catheter, thereby forming a generally arcuate shape that is at least semi-circular. The pigtail catheter can have radiopaque markers visible on an X-ray or other medical imaging device. The radiopaque markers are in the form of longitudinal markers, circumferential bands, etc. on the distal portion of the curled pigtail catheter. The pigtail catheter can additionally have one or more orifices for dispensing a drug and / or a contrast agent through the lumen.

[0013] In some aspects, a guide wire is inserted through the patient's skin and into a body cavity such as, for example, the femoral artery, radial artery, or brachial artery, and manipulated near the target site. The guide wire is inserted into the lumen of an embolic protection device, and the embolic protection device is pushed or tracked over the guide wire to the target site. When the guide wire is retracted from at least the distal portion of the catheter, the catheter assumes a generally arcuate shape. Radiopaque markers on the catheter are used for visualizing and positioning the catheter. Once the catheter is in place, the outer sheath is retracted to deploy the embolic filter, and the pull wire is retracted to bend the filter frame to position the distal opening of the filter across the vessel. The user can then perform procedures such as valve replacement, valve repair, radiofrequency ablation, etc. After the procedure is completed, the pull wire is advanced and the outer sheath is advanced to recapture the embolic filter and any debris trapped in the embolic filter. The device is then retracted from the vessel, and the catheter causes no damage to the vessel during retraction.

[0014] Another aspect is a method of capturing embolic debris during a closed-heart surgical procedure, the method including inserting a distal end of a catheter of an embolic protection device into a body cavity. The method further includes allowing the embolic filter to assume an expanded deployed configuration and retracting a pull wire to bend the filter frame such that a distal opening of the filter spans the body cavity.

[0015] In some aspects, the embolic protection device includes: a catheter; a self-expanding embolic filter coupled to the catheter; a push wire for reorienting the filter by bending the filter frame in a longitudinal direction and extending the frame in a radial direction; and an outer sheath movable relative to the embolic filter and the catheter. When the outer sheath is around the embolic filter, the outer sheath holds the embolic filter in a collapsed configuration and is retracted proximally to deploy the embolic filter. The outer sheath can recapture the embolic filter and any debris captured therein by advancing distally. The advantage of the push wire is its ability to bend and extend the frame, thereby orienting the filter opening towards the distal end of the device and causing the embolic filter to more fully engage the body cavity.

[0016] In some aspects, the catheter has a proximal end and a distal end. A lumen extends from the proximal end to the distal end along the longitudinal axis of the catheter. In some embodiments, the lumen can be configured to accommodate a guide wire.

[0017] In certain aspects, the catheter is a pigtail catheter. The pigtail catheter is configured to curl at the distal end of the catheter, thereby forming a generally arcuate shape that is at least semi-circular. The pigtail catheter can have radiopaque markers visible on an X-ray or other medical imaging device. The radiopaque markers are in the form of longitudinal markers, circumferential bands, etc. on the distal portion of the curled pigtail catheter. The pigtail catheter can additionally have one or more orifices for dispensing a drug and / or contrast agent through the lumen.

[0018] In some aspects, a guide wire is inserted through a patient's skin into a body cavity such as the femoral artery, radial artery, or brachial artery and manipulated near a target site. The guide wire is inserted into the lumen of an embolic protection device, and the embolic protection device is pushed or tracked along the guide wire to the target site. When the guide wire is retracted from at least the distal portion of the catheter, the catheter assumes a generally arcuate shape. Radiopaque markers on the catheter are used for visualizing and positioning the catheter. Once the catheter is in place, the outer sheath is retracted to deploy the embolic filter, and a pusher wire is advanced to bend and extend the filter frame to position the distal opening of the embolic filter across the vessel. Then, the user can perform procedures such as valve replacement, valve repair, radiofrequency ablation, etc. After the procedure is completed, the pusher wire is retracted and the outer sheath is advanced to recapture the embolic filter and any debris trapped in the embolic filter. Then the device is retracted from the vessel, and the catheter causes no damage to the vessel during retraction.

[0019] Another aspect is a method of capturing embolic debris during a closed-heart surgical procedure, the method including inserting a distal end of a catheter of an embolic protection device into a body cavity. The method further includes allowing the embolic filter to assume an expanded deployed configuration and advancing a pusher wire to bend and extend the filter frame such that the distal opening of the filter spans the body cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The following drawings are provided by way of example and are not intended to limit the scope of the claimed invention.

[0021] Figure 1A and 1B shows a partial side view of an embodiment of the embolic protection device of the present invention. In Figure 1A shows the embolic filter of the embolic protection device in a folded (undeployed) configuration. In Figure 1B shows the embolic filter in an expanded (deployed) configuration, where a pull wire fixed to the embolic filter frame is advanced to a distal position to cause the frame to assume its self-expanding and non-deflecting (i.e., non-bending) configuration.

[0022] Figure 1C shows a side perspective view of an embodiment of the embolic filter of the present invention, which assumes a partially deflected (i.e., partially bent) configuration, where a pull wire fixed to the embolic filter frame is partially longitudinally retracted to a proximal position.

[0023] Figure 1D shows a cross-sectional view of an embodiment of the embolic filter of the present invention, which assumes a fully deflected (e.g., fully bent) configuration, where the pull wire is fully longitudinally retracted to deflect the filter.

[0024] Figure 1E and 1FA front view of an embodiment of an embolic filter frame of the present invention is shown. Figure 1E In the filter frame is not unfolded, wherein the frame is folded and surrounded by an outer sheath. Figure 1F In the embodiment of the present invention, the outer sheath is longitudinally retracted and the filter frame is deployed to its self-expanding configuration.

[0025] Figures 2A to 2B A partial side view of an embodiment of the embolic protection device of the present invention including a shoulder is shown.

[0026] Figures 3A to 3D A partial side view of an embodiment of the embolic protection device of the present invention including an intermediate tube is shown.

[0027] Figures 4A to 4C A partial side view of an embodiment of the embolic protection device of the present invention including a deflector is shown.

[0028] Figure 5A An embodiment of an embolic protection device including a handle is shown. Figure 5B The distal portion of an embolic protection device including an embolic filter and a pigtail catheter is shown.

[0029] Figure 6A A partial side view of an embodiment of the embolic protection device of the present invention is shown with the embolic filter in a collapsed (undeployed) configuration.

[0030] Figure 6B and Figure 6C Shown are side and front end views, respectively, of an embolic filter in a self-expanding (deployed) configuration, wherein pushwires coupled to the embolic filter frame are retracted to a proximal position such that the frame assumes an undeflected (ie, unbent) configuration.

[0031] Figure 6D and Figure 6E Shown are side and front end views, respectively, of an embolic filter in a partially expanded configuration, wherein a pushwire coupled to the embolic filter frame is longitudinally advanced to a first distal position such that the frame assumes a deflected (ie, bent) configuration.

[0032] Figure 6F and Figure 6G A side view and a front view are shown, respectively, of an embolic filter in a fully expanded configuration, wherein a push wire connected to the embolic filter frame is longitudinally advanced to a position greater than that in FIG. Figure 6C The second distal position is further than the first distal position shown in the figure, so that the frame presents an extended configuration.

[0033] Figures 7A - 7C A partial side view of an embodiment of an embolic protection device of the present invention is shown having an actuation mechanism for operating an embolic filter.

[0034] Figure 8A and 8B shows an embodiment of the embolization protection device of the present invention, which has a handle for manually operating an embolization filter.

[0035] Figures 8C - 8F shows an example of the handle.

[0036] Figures 9A - 9E shows a step-by-step method of using the embolization protection device of the present invention.

[0037] Figure 10 shows the deflection and capture of embolization debris by the embolization protection device of the present invention including a deflector.

[0038] Figure 11 shows the deflection and capture of embolization debris by the embolization protection device of the present invention, where there is a second catheter device.

[0039] Figures 12A to 12D shows a step-by-step method of using the embolization protection device for operating an embolization filter of the present invention.

[0040] Figure 13A and 13B is a photograph of the distal portion of the embolization protection device of the present invention located within a cadaveric vessel according to Example 1. In Figure 13A the embolization protection device includes a longitudinal groove into which a second catheter is inserted side by side with the embolization protection device. In Figure 13B the second catheter is located near the embolization protection device lacking a longitudinal groove.

[0041] Figure 14 is a bar graph of the performance data of the embolization protection device (EPD-1 device) of the present invention according to Example 2.

[0042] Figures 15A to 15J is an image generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative subject according to Example 2.

[0043] Figure 16A is a photograph of an embolism captured by the embolization protection device (EPD-1 device) of the present invention according to Example 2.

[0044] Figure 16B is a photograph of collagen fragments captured within the filter of the embolization protection device (EPD-1 device) according to Example 2.

[0045] In the respective drawings, the same reference numerals indicate the same components. Detailed Description

[0046] The present invention provides an embolization protection device and a method of using the embolization protection device to capture embolic debris during a surgical procedure.

[0047] I. Definitions

[0048] As used in this application, the term "self-expanding" means to grow, spread, or unfold from a collapsed state when a restraining force or constraint is withdrawn or removed.

[0049] As used in this application, the term "closed-heart" refers to any surgical procedure in which the thoracic cavity involving the heart is not opened.

[0050] As used in this application, the term "woven fabric" means any material comprising multiple strands, where the strands are interwoven to form a mesh, net, or screen. By way of non-limiting example, examples of woven materials include meshes or nets that comprise polymers, metals, or metal alloys.

[0051] As used in this application, the term "non-woven fabric" means any material comprising a continuous film. Non-woven materials can be permeable, semi-permeable, or impermeable. For example, a permeable or semi-permeable non-woven material may optionally include one or more orifices through which fluid can pass.

[0052] As used in this application, the term "alloy" means a homogeneous mixture or solid solution produced by combining two or more metallic elements, for example to provide greater strength or corrosion resistance. By way of example, alloys include brass, bronze, steel, nitinol, cobalt-chromium, MP35N, 35NLT, Elgiloy, and the like.

[0053] As used in this application, the terms "nitinol" and "nickel-titanium" are used interchangeably and refer to an alloy of nickel and titanium.

[0054] As used in this application, "cobalt-chromium" refers to an alloy of cobalt and chromium.

[0055] As used in this application, "MP35N" refers to an alloy of nickel and cobalt.

[0056] As used in this application, "35NLT" refers to a cobalt-based alloy that may also contain chromium, nickel, molybdenum, carbon, manganese, silicon, phosphorus, sulfur, titanium, iron, and boron.

[0057] As used in this application, "Elgiloy" refers to an alloy of cobalt, chromium, nickel, iron, molybdenum, and manganese.

[0058] As used in this application, the term "body cavity" refers to the internal space of a tubular structure in the human body, such as an artery, intestine, vein, gastrointestinal tract, bronchus, renal tubule, and urethra. In certain instances, the body cavity refers to the aorta.

[0059] II. Embolization Protection Device

[0060] Although certain embodiments and examples are described below, those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Accordingly, the scope of the disclosure presented in this application should not be limited by any particular embodiment described below.

[0061] For the purposes of this disclosure, the terms "upper", "lower", "right", "left", "rear", "front", "vertical", "horizontal" and their derivatives shall be as in Figure 1B and 1F or as oriented in Figure 6B and 6C and shall relate to the present invention. However, it should be understood that unless explicitly stated to the contrary, the present invention may assume various alternative orientations. Similarly, for the purposes of this disclosure, the term "coupled" (in all its forms, coupled to, in coupling to, being coupled, etc.) generally refers to two components (electrical or mechanical) being joined directly or indirectly to each other. Such joining may be fixed or movable in nature; it may be achieved by two components (electrical or mechanical) and any other intermediate member being formed integrally with each other or with the two components as a single unitary body; and unless otherwise stated, it may be permanent in nature or may be movable or releasable.

[0062] Figure 1A and 1B and show embodiments of an embolic protection device 100. In these embodiments, the device 100 includes a catheter 102 (such as a pigtail catheter) having a proximal end 114, a distal end 116, and a lumen 118 extending from the proximal end 114 to the distal end 116. The lumen 118 may be configured to receive a guide wire 990 (see Figure 9A and 9B ), and the guide wire 990 may be longitudinally movable through the lumen to wind or straighten the distal portion 104 of the catheter 102 depending on whether the guide wire is retracted (to wind the distal portion) or extended (to straighten the distal portion). In some embodiments, the catheter 102 includes a distal portion 104 that is configured to present a generally arcuate shape that is at least semi-circular. The sidewall of the catheter 102 may optionally include one or more orifices 108 in the distal portion 104, which are configured to deliver one or more fluids (such as imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, etc.) to a body cavity 992 (see Figure 9A). A plurality of orifices 108 (the term "plurality" is intended to include embodiments in which the distal portion includes one orifice 108) are in fluid communication with the lumen 118. In some embodiments, the distal portion 104 of the catheter 102 includes one or more radiopaque markers 106. In some embodiments, the radiopaque markers 106 are wound around the distal portion of the catheter and may have the same or different widths. In other embodiments, the radiopaque markers are collinear with the lumen and extend to the distal end of the catheter. The device 100 also includes a self-expanding embolization filter 110 defined by a frame 124 and a filter medium 126, and a deployment mechanism 112 (such as a longitudinally retractable outer sheath or a longitudinally retractable ring). The embolization filter 110 is disposed around the catheter 102.

[0063] As Figure 1B shown, the embolization filter 110 in its deployed configuration includes a distal opening 140 defined by the frame 124, facing the distal end 116 of the catheter 102, and extending proximally from the distal opening 140 to a closed proximal end 142. The device 100 also includes a pull wire 122 that is coupled to the frame 124 and can be retracted to deflect or bend the frame 124 and change the orientation and shape of the distal opening 140.

[0064] In some embodiments, retracting the pull wire 122 can cause the distal opening 140 of the embolization filter 110 to engage at least a portion of the wall of the body lumen 992 (see Figure 9D ). Figure 1B The pull wire 122 is shown in a deployed configuration (i.e., not retracted or self-expanding configuration), in which the frame is generally oriented to extend in the distal longitudinal direction, although tilted slightly backward in the transverse direction (e.g., less than about 45 degrees). The catheter 102 may be partially surrounded by a support catheter 150 toward its proximal end 114, and the support catheter 150 terminates in a head 152 that is adjacent to the distal portion 104 of the catheter 102. The support catheter 150 may be made of a thick and rigid material to increase stiffness and provide a protective or support layer around the catheter 102.

[0065] Figure 1CIllustrated is an embolic filter 110 that is deployed (e.g., self-expands) by retraction of an expansion mechanism (e.g., an outer sheath) 112, where the frame 124 is partially deflected, i.e., partially bent, by retraction of a pull wire 122. The pull wire 122 is coupled to the frame 124 at a distal coupler 134. The distal opening 140 is defined primarily by a first portion 132 of the frame 124. The first portion 132 of the frame 124 defines the shape of the distal opening 140, which is substantially oval (i.e., shaped like an ellipse), or substantially ovoid or circular. In this embodiment, the portion 132 of the frame 124 may be generally oval and may terminate at its proximal end in a V-point, i.e., the portion 132 of the frame 124 may reverse its bent portion at one end of its generally oval shape (e.g., at its distal end) and taper at its proximal end. The distal opening 140 may be defined substantially by the frame 124, but may span the frame 124 adjacent to the tapered portion of the frame 124. The filter medium 126 may define a portion of the distal opening 140, where the filter medium 126 spans the frame 124, i.e., adjacent to the attachment point of the frame 124 to the catheter 102 or support catheter 150.

[0066] Attachment of the frame 124 to the support catheter 150 (or directly to the catheter 102 directly) is achieved via a second portion 130 of the frame 124 that surrounds the support catheter 150 (or catheter 102) and is angled relative to the longitudinal axis of the catheter 102. The second portion 130 of the frame 124 may be fixed in its position by friction and the tension of the embolic filter 110 in the transverse and / or longitudinal directions. In other embodiments, the fixed attachment of the second portion 130 of the frame 124 to the support catheter 150 (or catheter 102) may also be achieved via an adhesive, welding, etc.

[0067] The first portion 132 of the frame 124 may extend away from the catheter 102 in a first transverse direction and away from the second portion 130 of the catheter 102, and wrap around across the catheter 102 and extend in an opposite transverse direction. In this embodiment, the first portion 132 of the frame 124 includes two side edges (132a, 132b), each side edge extending generally away from the catheter 102 in the first transverse direction, then wrapping around on opposite sides of the catheter 102 and extending generally in an opposite transverse direction before converging and meeting to form a generally oval shape. As Figure 1F shown, the embolic filter 110 is symmetric about the pull wire 122. For ease of discussion, the embolic filter 110 is referred to as having a left side and a right side. The components on the left side of the embolic filter 110 are mirror symmetric to the components on the right side of the embolic filter 110.

[0068] When the pull wire 122 is in its advanced state (or partially but not fully retracted state), the frame 124 extends in a distal longitudinal direction as it extends from its attachment point with the catheter 102 (or support catheter 150). When the pull wire 122 is in its retracted state (i.e., fully retracted) (see Figure 1D and Figure 9E ), the frame 124 extends in a distal longitudinal direction near its attachment point with the catheter 102, but then bends such that it extends generally perpendicular to the longitudinal axis of the catheter 102.

[0069] Figure 1D FIG. shows a cross-sectional view of the distal opening 140 of the embolic filter 110 when the embolic filter 110 is in an expanded configuration and when the pull wire 122 is in a fully retracted state such that the frame 124 is fully deflected (or bent). The pull wire 122 causes the frame 124 to deflect or bend laterally outward in a proximal longitudinal direction. In the fully deflected configuration (i.e., when the pull wire 122 is fully retracted), the distal opening 140 of the embolic filter 110 can extend transversely across the body cavity 992 generally perpendicular to the longitudinal axis of the catheter 102 and generally perpendicular to the longitudinal axis of the body cavity 992 (see Figure 9D and 9E ). The fully deflected (or bent) configuration may allow the embolic filter 110 to more fully engage the body cavity 992. In this fully deflected configuration, the distal opening 140 is generally perpendicular to the longitudinal axis of the catheter 102. In the fully deflected configuration, the width x of the distal opening 140 may increase compared to the corresponding dimension in the non-deflected configuration. Similarly, in the fully deflected configuration, the length y of the distal opening 140 may decrease compared to the corresponding dimension in the non-deflected configuration. By increasing the width x in the bent configuration, the frame 124 defining the distal opening 140 can more fully engage the body cavity 992.

[0070] In each Figures 1A - 1D of the embodiments shown, the catheter 102 extends through the distal opening 140 of the embolic filter 110, and the frame 124 extends away from the catheter 102 in a first lateral direction and then bends around the catheter 102 in the opposite direction.

[0071] The embolic protection device 100 can assume a non-deflected ( Figure 1B ), partially deflected ( Figure 1C ), or fully deflected ( Figure 1DConfigurations. These configurations are achieved by engaging the pull wire 122 to a fully advanced, partially retracted (or partially advanced), or fully retracted state. In the fully advanced state, the pull wire 122 is in the distal position. In the fully retracted state, the pull wire 122 is in the proximal position. When longitudinally retracted to the proximal position, the pull wire 122 is configured to deflect (or bend) the frame 124 such that the distal opening 140 of the filter 110 is generally perpendicular to the longitudinal direction of the catheter 102, and the distal opening 140 faces the distal end 116 of the catheter 102. When longitudinally advanced to the distal position, the pull wire 122 is configured to position the frame 124 such that the distal opening 140 of the filter 110 defined by the frame 124 is generally parallel to the longitudinal direction of the catheter 102 or at an angle less than about 45 degrees.

[0072] In some embodiments, the distal opening 140 of the embolic filter 110 has a diameter of from about 2 cm to about 6 cm (e.g., a diameter of from about 2.5 cm to about 5 cm or about 4.5 cm). The embolic filter 110 may include any suitable size or diameter to accommodate the anatomical variability of the patient body cavity 992 (see Figure 9C ). In some embodiments, the embolic filter 110 is coupled to the catheter 102 at the proximal and / or distal end of the embolic filter 110 and / or at any other point therebetween. For example, the embolic filter 110 may be coupled to the catheter 102 via the frame 124, particularly the second portion 130 (distal attachment point) of the frame 124, and may also be coupled to the catheter 102 at the attachment point of the filter medium 126 within the sheath 112.

[0073] Figure 1E and 1F shows the frame 124 of the embolic filter 110. In Figure 1E the illustrated embodiment, the frame 124 is folded within the outer sheath 112, i.e., the sheath 112 is advanced over the frame 124. In Figure 1FIn the illustrated embodiment, the frame 124 is deployed outside the sheath 112, i.e., the sheath 112 is retracted. The pull wire 122 is coupled to the frame 124 at the distal coupler 134. The pull wire 122 can be coupled to the frame 124 at the distal coupler 134 by a variety of methods, including by means of a hole in the frame 124 through which the pull wire 122 can pass and be crimped to hold it in place. The distal coupler 134 can also include a variation in the bent portion of the frame 124, i.e., by reversing the bent portion of the frame 124 and tapering it. This bent portion, along with the bent portion of the frame 124 adjacent the attachment point of the frame 124 to the catheter 102, can assist in folding the frame 124 so that the sheath 112 can be advanced over the embolic filter 110. In some embodiments, the frame 124 comprises a shape memory material (such as a metal alloy or a polymer). Examples of shape memory materials include, but are not limited to, nitinol, cobalt chrome, and / or other metal alloys such as MP35N, 35NLT, elgiloy, etc. In some embodiments, the frame 124 is laser cut from tubing or sheet material.

[0074] Figure 2A and Figure 2B An embodiment of an alternative deployment mechanism for an embolic protection device 200 is shown, the embolic protection device including a catheter 202, an embolic filter 210, and a movable outer sheath 212. In some embodiments, the outer sheath 212 can include an optional lip 260 that projects inwardly from the distal end of the outer sheath 212. The catheter 202 can include one or more shoulders 262 (such as a distal shoulder 262a and a proximal shoulder 262b) that project outwardly from the outer wall of the catheter 202. The lip 260 of the outer sheath 212 is configured to engage one or more shoulders 262 of the catheter 202 to inhibit or prevent excessive movement of the outer sheath 212 in the proximal or distal direction. The lip 260 and the shoulders 262 can be arcuate, forked, and combinations thereof, etc.

[0075] In some embodiments, the outer sheath 212 and / or the catheter 202 include nubs and / or stops that are configured to provide information to the user about the longitudinal position of the outer sheath without inhibiting further movement. In some embodiments, the outer sheath 212 and the catheter 202 include the lip 260, the shoulders 262, as well as stops and nubs (such as to overly inhibit longitudinal movement of the outer sheath 212 in either direction and provide information about the range of movement of the outer sheath 212 relative to the catheter 202 (such as 1 / 2 retracted, 1 / 4 retracted, etc.).

[0076] The benefits of the outer sheath 212 deployment mechanism can include its simplicity, ease of operation, and few moving parts. The embolization protection device 200 is well-suited for use in conjunction with delicate cardiac procedures with high risk. As the duration of the procedure increases, the risk of complications generally also increases. Thus, it is advantageous to enable the user to quickly and easily deploy and recapture the embolization filter 210. The more complex a device, the more difficult it may be to operate and the more likely it is to malfunction or cause adverse effects. The ability to move the outer sheath 212 relative to the embolization filter 210 can be beneficial to allow the user to partially recapture the embolization filter 210, for example to adjust the width of the distal opening 140. In some embodiments, narrowing the distal opening 140 allows the user to introduce a second catheter or instrument into the patient's body cavity 992 (see Figure 9D ), and manipulate the second catheter or instrument around and past the catheter 202 and the embolization filter 210 as described in this application. In some embodiments, the embolization protection device as described in this application may have longitudinally extending grooves (not shown) along its surface (e.g., along the catheter 102, along the support catheter 150, or along the deployment mechanism (e.g., the outer sheath) 112). In such embodiments, a second catheter or instrument can be inserted while engaging the groove to guide the second device alongside the embolization protection device.

[0077] Figures 3A to 3D An embodiment of an embolization protection device 300 is shown, where an embolization filter 310 is movably coupled to a catheter 302 by means of a frame 324 and is longitudinally movable relative to the catheter 302. In some embodiments, the embolization filter 310 is coupled to an intermediate tube 330 that at least partially circumferentially surrounds the catheter 302. The intermediate tube 330 is longitudinally movable relative to the catheter 302. The outer sheath 312 is configured to at least partially circumferentially surround the catheter 302 and the intermediate tube 330. The intermediate tube 330 and the outer sheath 312 can be moved simultaneously and independently. The longitudinal position of the embolization filter 310 relative to the catheter 302 can be adjusted while the embolization filter 310 is in a folded configuration or in an expanded configuration that is deployed or partially deployed. In some embodiments, the perimeter of the distal opening of the embolization filter 310 includes one or more radiopaque markers to allow the user to visualize the position of the distal opening relative to various anatomical landmarks. For example, if the user is performing surgery on a patient's aortic valve and wants to prevent embolization into the cerebral arteries, radiopaque markers can be used to ensure that the distal opening of the embolization filter 310 is located in the ascending aorta upstream of the carotid arteries.

[0078] Figure 3A An embolization filter 310 is shown restricted in a closed configuration by the distal ends of the outer sheath 312 and the intermediate tube 330 at position (a). If the intermediate tube 330 remains stationary at position (a), the outer sheath 312 can be retracted to as Figure 3CDeploy the embolization filter 310 as shown. If, instead, the intermediate tube 330 and the outer sheath 312 are moved simultaneously, then while adjusting the longitudinal position of the embolization filter 310, the embolization filter 310 remains restricted by the outer sheath 312. For example, Figure 3B shows that the embolization filter 310 remains restricted by the outer sheath 312 while the intermediate tube 330 has been retracted such that the distal end of the intermediate tube 330 is in position (b). Then, if the intermediate tube 330 remains stationary at position (b), the outer sheath 312 can be retracted to deploy the embolization filter 310 as Figure 3D shown. The intermediate tube 330 and the outer sheath 312 can be moved to adjust the longitudinal position of the embolization filter 310 in a deployed or partially deployed configuration. For example, the intermediate tube 330 and the outer sheath 312 can be moved simultaneously to retract the intermediate tube 330 from the position as Figure 3C shown to the position (b) as Figure 3D shown.

[0079] In addition to those described in detail in this application, various deployment mechanisms for embolization filters are also feasible. For example, the deployment system can include a portion of an annular sheath that includes inwardly projecting ends guided in a track along the catheter body. Some such embodiments can be beneficial in reducing the profile of the catheter. Again, for example, the deployment system can include a threaded sheath that moves longitudinally when the user twists it. Yet again, for example, the deployment system can include a plurality of annular bands that can capture the embolization filter longitudinally and / or circumferentially. Combinations of the deployment systems described in this application and other deployment systems are also feasible.

[0080] Figures 4A to 4C Shows another embodiment of an embolization protection device 400 that includes a catheter 402, a deflector 460, an embolization filter 410, and a movable outer sheath 412. In some embodiments, the embolization protection device 400 is similar to the embolization protection device 100 but includes a deflector 460.

[0081] Various types and designs of deflectors can be used with an embolization protection device such as the embolization protection device 400. Such deflectors can have different shapes and / or sizes and can vary depending on the location and manner in which they are coupled to the catheter. For example, deflectors can be made in various sizes, for example to accommodate differences in patient anatomy. In some embodiments, the deflector includes a shape memory material, such as including nickel-titanium alloys, cobalt-chromium, and / or alloys such as MP35N, 35NLT, elgiloy. In some embodiments, the deflector includes a porous membrane, such as a semi-permeable polyurethane membrane / material, that is mounted to a self-expanding frame, for example, a frame that includes a shape memory material.

[0082] FigureFigures 4A - 4C An example of the deflector 460 shown has a generally butterfly or oval shape, with two flanks or lobes 460a and 460b extending to either side of the central axis 464. The shape, material, etc. of the flanks or lobes 460a and 460b can be the same or different. The deflector 460 is coupled to one side of the conduit 402 via an elongate member 462, one end of which is coupled to the central axis 464 of the deflector 460 (e.g., by adhesion, welding, soldering, coupling using separate components, combinations thereof, etc.), and the other end of which is coupled to the conduit 402. In some embodiments, the elongate member 462 includes a shape memory material, such as including nitinol, cobalt chromium, and / or alloys such as MP35N, 35NLT, elgiloy, etc., which is configured (e.g., shape set) to bias the deflector away from the conduit 402. The deflector 460 is configured to, for example when not constrained by the outer sheath 412, be released into an open configuration as shown in Figure 4B and Figure 4C In some embodiments, the deflector 460 is configured to fold away from the elongate member 462 along the central axis 464 such that the flanks or lobes 460a and 460b converge together, and the deflector 460 can be accommodated in, for example, an outer sheath 412 as shown in Figure 4A As shown in Figure 4A The deflector 460 can initially be folded and accommodated in the outer sheath 412 such that the flanks or lobes 460a and 460b are positioned distally of the central axis 464. In some embodiments, the deflector 460 can initially be folded in the opposite direction such that the flanks or lobes 460a and 460b are positioned proximally of the central axis 464.

[0083] In some embodiments, the conduit 402 is a pigtail catheter as shown in Figure 4A and Figure 4B and described in this application. The conduit 402 includes a distal portion 404 that is configured to present a generally arcuate shape that is at least semi-circular. In some embodiments, the distal portion 404 of the conduit 402 includes one or more radiopaque markers 406. The sidewall of the conduit 402 optionally includes one or more orifices 408 in the distal portion 404, which are configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, etc.) to a body cavity.

[0084] The conduit 402 has a proximal end 414 and a distal end 416. As shown in Figure 4BAs shown, an example of catheter 402 is partially surrounded by support catheter 450 towards its proximal end 414, the support catheter 450 terminating at head 452 which is adjacent to the distal portion 404 of catheter 402. The support catheter 450 can be made of a thick and rigid material to increase stiffness and provide a protective or support layer around catheter 402.

[0085] As Figure 4B shown, embolic filter 410 includes frame 424 and filter medium 426. In its deployed configuration, embolic filter 410 includes a distal opening 440 defined by frame 424, facing the distal end 416 of catheter 402, and extending proximally from distal opening 440 to a closed proximal end 442. Device 400 also includes a pull wire 422 which is coupled to frame 424 in a manner similar to that described above with reference to Figures 1B - 1D and can be retracted to deflect or bend frame 424 and change the orientation and shape of distal opening 440.

[0086] In some embodiments, deflector 460 and embolic filter 410 can be coupled to another type of catheter, e.g., a catheter not configured to present a distal portion having an arcuate shape. The embolic filter 410 can be similar to Figures 1A - 1D embolic filters 110 and 210 shown in FIGS. 2A and 2B and described herein in this application. In some embodiments, the embolic filter 410 is coupled to catheter 402 proximal to the deflector 460, e.g., as Figures 4A - 4B shown. In some embodiments, the embolic filter 410 is coupled to catheter 402 distal to the deflector 460. The embolic filter 410 is coupled such that it is disposed around catheter 402. This configuration facilitates allowing the embolic filter 410 to engage the wall of body cavity 992 (see Figure 9D ) because the position of catheter 402 within body cavity 992 (see Figure 9D ) may be affected by the deployed deflector 460.

[0087] The combination of deflector 460 and embolic filter 410 can be beneficial in providing additional protection against potential complications caused by emboli in the blood stream. For example, if the embolic filter 410 (e.g., the distal end of embolic filter 410) is distal to the deflector 460, the embolic filter 410 can serve as the primary embolic protection device, while the deflector 460 can serve as an auxiliary embolic protection device. If some blood can flow around the embolic filter 410 rather than through it, the deflector 460 serves as an auxiliary (or backup) protection device and prevents any debris not captured by the embolic filter 410 from entering the cerebral artery and proceeding to the brain. If the embolic filter 410 is close to the deflector 460, the deflector 460 can serve as the primary embolic protection device, while the embolic filter 410 can serve as an auxiliary embolic protection device. The deflector 460 first deflects debris away from the carotid artery, and then when blood flows through the descending aorta, the embolic filter 410 captures the debris (e.g., including deflected debris).

[0088] In some embodiments, the catheter 402 and the outer sheath 412 can have lips, shoulders, nodules, and / or stops, such as those similar to Figure 2A and 2B shown and described in this application. For example, the lips, shoulders, nodules, and / or stops can be positioned on the catheter 402 distal to the deflector 460, between the deflector 460 and the embolic filter 410, and proximal to the embolic filter 410 to engage corresponding lips, shoulders, nodules, and / or stops on the outer sheath 412. The lips, shoulders, nodules, and / or stops can be beneficial in providing information to the user about the longitudinal position of the outer sheath 412 such that the user knows when one or both of the deflector 460 and the embolic filter 410 are deployed or neither is deployed. In some embodiments, either or both of the deflector 460 and the embolic filter 410 can be movably coupled to the catheter 402 via an intermediate tube similar to Figures 3A - 3D shown and described in this application.

[0089] Similar to Figures 1A - 1E An embodiment of an embolic protection device 500 similar to the embolic protection device 100 is shown in Figure 5A and 5B . The embolic protection device 500 includes a catheter 502, an embolic filter 510, a movable outer sheath 512, and a handle 570. In some embodiments, the catheter 502 is as Figure 5BThe pigtail catheter as shown in the close-up view and described in this application. The catheter 502 includes a distal portion 504 configured to present a generally arcuate shape that is at least semi-circular. In some embodiments, the distal portion 504 of the catheter 502 includes one or more radiopaque markers 506. The sidewall of the catheter 502 may optionally include one or more apertures 508 in the distal portion 504, which are configured to deliver one or more fluids (such as imaging dye, contrast agent, oxygenated blood, saline, any combination thereof, etc.) to the body cavity.

[0090] As Figure 5B shown, the embolization filter 510 includes a frame 524 and a filter medium 526. In its deployed configuration, the embolization filter 510 opens towards the distal end 516 of the catheter 502. The device 500 also includes a pull wire 522, which is coupled to the frame 524 in a manner similar to that described above with reference to Figures 1B to 1D and can be retracted to deflect or bend the frame 524 and change the orientation and shape of the embolization filter 510.

[0091] Return Figure 5A , the handle 570 has a wire engagement mechanism 574 configured to advance or retract the pull wire 522 by the movement of a first slider 572. The handle 570 also has a sheath engagement mechanism 578 configured to advance or retract the deployment mechanism (such as an outer sheath) 512 by the movement of a second slider 576.

[0092] Figures 6A - 6G An embodiment of an embolization protection device 600 is shown. In these embodiments, the embolization protection device 600 includes a catheter 602 (such as a pigtail catheter) having a proximal end 614, a distal end 616, and a lumen 618 extending from the proximal end 614 to the distal end 616 along the longitudinal axis of the catheter 602. The lumen 618 may be configured to accommodate a guide wire 1290 (see Figure 12A ), which can move longitudinally through the lumen to wind or straighten the distal portion 604 of the catheter depending on whether the guide wire is retracted (to wind the distal portion) or extended (to straighten the distal portion). In some embodiments, the catheter 602 includes a distal portion 604 configured to present a generally arcuate shape that is at least semi-circular. The sidewall of the catheter 602 may optionally include one or more apertures 608 in the distal portion 604, which are configured to deliver one or more fluids (such as imaging dye, contrast agent, oxygenated blood, saline, any combination thereof, etc.) to the body cavity 1292 (see Figure 12A). A plurality of orifices 608 (the term "plurality" is intended to include embodiments in which the distal portion 604 includes one orifice 608) are in fluid communication with the lumen 618. In some embodiments, the distal portion 604 of the catheter 602 includes one or more radiopaque markers 606. In some embodiments, the radiopaque markers 606 are wound around the distal portion 604 of the catheter 602 and may have the same or different widths. The embolization protection device 600 further includes a self-expanding embolization filter 610 defined by a frame 624 and a filter medium 626, and a deployment mechanism 612 (such as a longitudinally retractable outer sheath or a longitudinally retractable ring). The embolization filter 610 is disposed around the catheter 602.

[0093] Figure 6B Shown is the embolization filter 610 deployed in a self-expanding configuration by retraction of the deployment mechanism (such as the outer sheath) 612. The embolization filter 610 includes a distal opening 640 defined by the frame 624, facing the distal end 616 of the catheter 602, and extending proximally from the distal opening 640 to a closed proximal end 642. The embolization protection device 600 further includes a pusher wire 622 coupled to the frame 624. The pusher wire 622 can be advanced in the distal direction to deflect (or bend) and extend the frame 624 and, in turn, change the configuration of the embolization filter 610 between self-expanded, partially expanded, and fully expanded. In some embodiments, advancing the pusher wire 622 may cause the distal opening 640 of the embolization filter 610 to change orientation, shape, and / or size to engage at least a portion of the wall of the body lumen 1292 (see Figure 12D ). Figure 6B Shown is the pusher wire 622 in a retracted (i.e., not advanced) state, where the frame 624 extends in the distal longitudinal direction, although it is angled (e.g., less than about 45 degrees) backward in the transverse direction toward the proximal end 614. The catheter 602 can be partially surrounded by a support catheter 650 toward its proximal end 614, and the support catheter 650 terminates in a head 652 adjacent to the distal portion 604 of the catheter 602. The support catheter 650 can be made of a thick and rigid material to increase stiffness and provide a protective or support layer around the catheter 602.

[0094] Figure 6C , 6EFIGs. 6G respectively show front views of the embolic filter 610 in a distal self-expanding, partially expanded, and fully expanded configuration as viewed from the distal opening 640. For clarity, the catheter 602 has been removed from these views. The frame 624 includes two side edges (624a, 624b), each side edge extending generally away from the catheter 602 / support catheter 650 in a first transverse direction, then wrapping around the catheter 602 / support catheter 650 on opposite sides and extending generally in an opposite transverse direction before converging and merging to form a generally oval (i.e., oval-shaped) or alternatively, a generally ovoid (i.e., football-shaped) or circular shape. As shown, the embolic filter 610 is symmetric about a plane (identified by the dashed line labeled "P" in the figure). For ease of discussion, the embolic filter 610 is referred to as having a left side and a right side. The components on the left side of the embolic filter 610 are mirror symmetric to the components on the right side of the embolic filter 610.

[0095] Figure 6D and 6E FIG. shows the embolic filter 610 in a partially expanded configuration, where the frame 624 is deflected (i.e., bent) by the advancement of the pusher wire 622 in the distal direction. The frame 624 includes a movable portion 630 and a fixed portion 632. The movable portion 630 of the frame 624 is longitudinally movable relative to the catheter 602 / support catheter 650. Relative to the catheter 602 / support catheter 650, the movable portion 630 can move longitudinally while the fixed portion 632 cannot. The frame 624 is coupled to the pusher wire 622 at the movable portion 630. In one convenient embodiment, the pusher wire 622 and the movable portion 630 are joined by crimping. In other embodiments, the pusher wire 622 and the movable portion 630 are joined by welding, adhesive, or threading. The frame 624 is attached to the support catheter 650 (or alternatively, directly attached to the catheter 602) through the fixed portion 632. The fixed portion 632 of the frame 624 can be attached to the catheter 602 / support catheter 650 by welding, adhesive, etc.

[0096] Starting from the fixed portion 632, the frame 624 extends in a distal longitudinal direction and then bends at an angle relative to the longitudinal axis of the catheter 602 / support catheter 650. When the pusher wire 622 is in its retracted state, the frame 624 bends at an acute angle and extends in a proximal longitudinal direction such that the frame 624 folds onto itself (see Figure 6B ). Advantageously, in this configuration, the embolic filter 610 can more effectively retain the embolic debris captured during the procedure. The bent portion of the frame 624 adjacent to the movable portion 630 can assist in folding the frame 624 to allow the outer sheath 612 to be advanced over the embolic filter 610.

[0097] Figure 6EShows a front view of the distal end of the embolization filter 610 as seen from the distal opening 640 when the pusher wire 622 is advanced and the embolization filter 610 is in a partially expanded configuration. The advanced pusher wire 622 forces the movable portion 630 forward relative to the catheter 602 / support catheter 650 (shown as an arrow pointing away from the support catheter 650 in Figure 6D . This in turn causes the frame 624 to deflect or bend longitudinally in the distal direction and laterally outward. In the deflected configuration (i.e., when the pusher wire 622 is advanced), the distal opening 640 of the embolization filter 610 can be substantially perpendicular to the longitudinal axis of the catheter 602 / support catheter 650 and can extend laterally across the body cavity 1292 substantially perpendicular to the longitudinal axis of the body cavity 1292 (see Figure 12D ). In the deflected configuration, the width X of the distal opening 640 is increased compared to the corresponding dimension in the non-deflected configuration bent . By increasing the width X in the bent configuration bent , the frame 624 defining the distal opening 640 engages the body cavity 1292.

[0098] Figure 6F And Figure 6G show the embolization filter 610 in a fully expanded configuration, where the frame 624 is extended by further advancement of the pusher wire 622 in the distal direction. Further moving the pusher wire 622 distally will cause the movable portion 630 to be pushed laterally relative to the catheter 602 / support catheter 650. This in turn causes the frame 624 to extend radially outward away from the catheter 602 / support catheter 650 (shown as left and right direction arrows pointing away from the support catheter 650 in Figure 6G ). In some embodiments, in addition to extending the frame 624 in the radial direction, the advanced pusher wire 622 also causes the movable portion 630 to move forward relative to the catheter 602 / support catheter 650, which in turn causes the frame 624 to bend further in the longitudinal direction. In one embodiment, the movable portion 630 has a curved or bent portion to assist in extending the frame 624 in the radial direction.

[0099] In the extended configuration, the width X across the distal opening 640 extended is increased compared to the corresponding dimension (X bent ) in the partially expanded configuration of the embolization filter 610. By increasing the width X in the extended configuration extended , the frame 624 defining the distal opening 640 engages the body cavity 1292. The width of the distal opening 640 in the partially expanded configuration (X bent ) and the fully expanded configuration (X extended)(and an increase between them and intermediate configurations therebetween) can represent a range of filter sizes or diameters, e.g., from 25 millimeters (mm) to 40 mm. This filter size range accommodates variations in the patient's vasculature. Advantageously, certain embodiments of the embolization protection device 600 provide a single device that can be customized for a particular patient and / or a particular surgical procedure, rather than a single size fitting all devices or different sizes fitting multiple devices. For example, a surgeon can expand the embolization filter 610 to a first size and then adjust the embolization filter 610 to a second size to better fit within the patient's vasculature.

[0100] In some embodiments, the diameter of the distal opening 640 of the embolization filter 610 is from about 2 centimeters (cm) to about 6 cm (e.g., from about 2.5 cm to about 4 cm or about 4.5 cm). The embolization filter 610 can include any suitable size or diameter to accommodate anatomical variability in the patient's body cavity 1292 (see Figure 12A ).

[0101] Figures 7A to 7C Another embodiment of an embolization protection device 700 is shown, which includes a catheter 702, an embolization filter 710, a movable outer sheath 712, and an actuation mechanism for operating the embolization filter 710. A portion of the catheter 702 terminates at a fixed inner catheter 750 at the head 752 and is slidably received and supported. The fixed inner catheter 750 can be made of a thick and rigid material to increase stiffness and provide a protective or support layer around the catheter 702. The embolization filter 710 is disposed around the fixed inner catheter 750 and is configured to self-expand into a radially expanded configuration as shown Figure 7A when not restricted or constrained by the outer sheath 712.

[0102] The embolization filter 710 includes a frame 724 and a filter medium 726. The frame 724 defines a distal opening 740 of the embolization filter 710 and includes a movable portion 730 for controlling the size or diameter of the distal opening 740. The embolization filter 710 extends proximally from the distal opening 740 to a closed proximal end 742. The frame 724 also includes a fixed portion 732 for attaching the frame 724 to the fixed inner catheter 750 at a location adjacent to the closed proximal end 742 of the embolization filter 710. In some embodiments, the embolization protection device 700 is similar to Figures 6A - 6G the embolization protection device 600 but includes an actuation mechanism.

[0103] The actuation mechanism includes an inner catheter 756 and an outer catheter 758. The inner catheter 756 slides on the stationary inner catheter 750. The outer catheter 758 slides on the inner catheter 756. The movement of the inner catheter 756 and the outer catheter 758 relative to the stationary inner catheter 750 controls the size or diameter of the embolization filter 710, which will be described in more detail below.

[0104] The embolization protection device 700 further includes a pusher wire 722 coupled to the distal portion 764 of the outer catheter 758. The pusher wire 722 is longitudinally movable through the outer catheter 758 between a fully retracted state, a partially advanced (or partially retracted) state, and a fully advanced state. The pusher wire 722 is further coupled to the movable portion 730 of the frame 724. Moving the outer catheter 758 relative to the stationary inner catheter 750 translates into moving the pusher wire 722 between the fully retracted, partially advanced, and fully advanced states. This in turn pushes the movable portion 730, causing the frame 724 to deflect (or bend) or extend.

[0105] In various embodiments of the embolization protection device 700, as described above, the foregoing device components may be coupled to one another by any number of means and techniques. For example, in one convenient embodiment, a catheter made of polyether block amide (PEBAX®) or other similar biocompatible material attaches the pusher wire 722 to the distal portion 764 of the outer catheter 758, attaches the top guide 760 to the distal portion 766 of the inner catheter 756, and attaches the bottom guide 762 to the stationary inner catheter 750. Additionally or alternatively, the device components may be bonded together with a biocompatible adhesive.

[0106] The actuation mechanism further includes a top guide 760 and a bottom guide 762 for guiding the deflection and extension of the frame 724 such that the distal opening 740 of the embolization filter 710 faces the distal end (or working end) of the device 220 when it expands. In some embodiments, the top guide 760 and the bottom guide 762 keep the movable portion 730 and the fixed portion 732 of the frame 724 straight, respectively. The top guide 760 and the bottom guide 762 are disposed at opposite points around the stationary inner catheter 750 and have respective portions disposed along the stationary inner catheter 750. One end of the top guide 760 is coupled to the distal portion 766 of the inner catheter 756. A portion of the top guide 760 remote from the distal portion 766 is slidably engaged with the stationary inner catheter 750 at or near the closed proximal end 742 of the embolization filter 710. For example, a portion of the top guide 760 slides along the stationary inner catheter 750 below the filter medium 726 and through the closed proximal end 742 of the embolization filter 710. The bottom guide 762 is fixedly attached to the stationary inner catheter 750 at or near the closed proximal end 742 of the embolization filter 710.

[0107] At the distal opening 740 of the embolization filter 710, the top guide 760 and the bottom guide 762 can move away from the fixed inner catheter 750. The top guide 760 slidably receives the movable portion 730 of the frame 724, while the bottom guide 762 receives the fixed portion 732. This arrangement causes the top guide 760 and the bottom guide 762 (when moving from the closed proximal end 742 of the embolization filter 710 to the distal opening 740) to flare out or bend outwardly from the fixed inner catheter 750, giving the embolization filter 710 an overall funnel-like appearance. The top guide 760 and the bottom guide 762 also support the filter medium 726 between the distal opening 740 and the closed proximal end 742 of the embolization filter 710 in the longitudinal and transverse directions. In a convenient embodiment, the top guide 760 and the bottom guide 762 are hypotubes made of stainless steel, polyetheretherketone (PEEK), or other biocompatible materials.

[0108] Figure 7A A situation is further shown where the outer sheath 712 is fully retracted over the embolization filter 710, exposing the embolization filter 710. The inner catheter 756 and the outer catheter 758 are in their initial positions (marked as "A" in the figure) relative to the fixed inner catheter 750. In the case where the embolization filter 710 has no sheath, the movable portion 730 and the fixed portion 732 of the frame 724 bend outwardly away from the fixed inner catheter 750 together with the top guide 760 and the bottom guide 762. This causes the distal opening 740 of the embolization filter 710 to be angled relative to the fixed inner catheter 750. For example, the frame 724 and the fixed inner catheter 750 form an angle of 45 degrees or less. At this stage of deployment, the embolization filter 710 is in a self-expanding configuration where the frame 724 does not bend.

[0109] Figure 7B The distal opening 740 is shown partially expanded to a first size or diameter. The inner catheter 756 and the outer catheter 758 are uniformly advanced distally over the fixed inner catheter 750. Relative to the fixed inner catheter 750, the inner catheter 756 and the outer catheter 758 move from their initial positions (marked as "A" in the drawing) to their intermediate positions (marked as "B" in the drawing). The uniform movement of the inner catheter 756 and the outer catheter 758 advances the push wire 722 and the top guide 760 together, and then longitudinally pushes the movable portion 730 of the frame 724 in the distal direction (forward direction). This rotates the distal opening 740 of the embolization filter 710 into an orientation substantially perpendicular to the longitudinal axis of the fixed inner catheter 750 and expands the distal opening 740 to the first size (e.g., a diameter of about 25 mm).

[0110] Figure 7CThe distal opening 740 that is fully expanded to a second size greater than the first size is shown. The outer catheter 758 is advanced distally over the inner catheter 756 and the stationary inner catheter 750. With the inner catheter 756 not moving, the outer catheter 758 moves from its intermediate position (marked as "B" in the figure) to its final position (marked as "C" in the figure) relative to the stationary inner catheter 750. The continued distal movement of the outer catheter 758 causes the pusher wire 722 to move without moving the top guide 760. The length of the movable portion 730 of the frame 724 extends radially out from the top guide 760 (i.e., beyond the plane of the page), thereby extending the frame 724 and further expanding the distal opening 740 of the embolic filter 710 to the second size (e.g., a diameter of about 40 mm).

[0111] Figures 8A to 8F An embodiment of an embolic protection device 800 is shown, which device includes a catheter 802, an embolic filter 810, a movable outer sheath 812, and a handle 870 for manually operating the embolic filter 810. In Figure 8B it, the embolic protection device 800 further includes a pusher wire 822, a filter frame 824, a filter medium 826, a movable portion 830, a fixed portion 832, a stationary inner catheter 850, an inner catheter 856, an outer catheter 858, a top guide 860, and a bottom guide 862 arranged in a configuration similar to the configuration described above with reference to Figures 7A - 7C . For example, the pusher wire 822 is coupled to the distal portion 864 of the outer catheter 858, and one end of the top guide 860 is coupled to the distal portion 866 of the inner catheter 856. In some embodiments, the embolic protection device 800 is similar to Figures 7A - 7C the embolic protection device 700 but with the addition of the handle 870.

[0112] Figure 8A The handle 870 having a first slider 872 is shown, which first slider 872 is operable to manually retract the outer sheath 812 over the catheter 802 and the embolic filter 810 to deploy the embolic filter 810 in a self-expanding configuration. The first slider 872 is also used to manually advance the outer sheath 812 over the catheter 802 and the embolic filter 810 and to fold / restore the embolic filter 810. The handle 870 further includes a second slider 874, which is operable to manually increase and decrease the size or diameter of the distal opening 840 of the embolic filter 810 (the embolic filter 810 extends proximally from the distal opening 840 to the closed proximal end 842).

[0113] In some embodiments, the catheter 802 is as Figure 8BThe pigtail catheter shown and described in this application. Catheter 802 includes a distal portion 804 configured to present a generally arcuate shape that is at least semi-circular. In some embodiments, the distal portion 804 of catheter 802 includes one or more radiopaque markers 806. The sidewall of catheter 802 may optionally include one or more orifices 808 in the distal portion 804, which are configured to deliver one or more fluids (such as imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, etc.) to a body cavity.

[0114] Catheter 802 has a proximal end, a distal end 816, and a lumen 818 extending between the proximal and distal ends 816. The lumen 818 may be configured to accommodate a guide wire 1290 (see Figure 12A and 12B ), which can be longitudinally moved through the lumen to wind or straighten the distal portion 804 of catheter 802 depending on whether the guide wire is retracted (to wind the distal portion) or extended (to straighten the distal portion). The orifices 808 and the lumen 818 may be in fluid communication with each other to deliver one or more fluids to the body cavity as described above.

[0115] As Figure 8B shown, an example of catheter 802 is partially surrounded by a fixed inner catheter 850 towards its proximal portion, and the fixed inner catheter terminates at a head 852 proximal to the distal portion 804 of catheter 802. The fixed inner catheter 850 may be made of a thick and rigid material to increase stiffness and provide a protective or support layer around catheter 802.

[0116] Figure 8C An example of a handle 870 is shown (the handle cover is removed for clarity), and the handle 870 includes a sheath engagement mechanism 876 configured to advance or retract an outer sheath 812 by the movement of a first slider 872. The outer sheath 812 is coupled to the sheath engagement mechanism 876. Many suitable means (such as fasteners and / or adhesives) or techniques (such as sonic welding, solvent welding, and overmolding) can be used to couple the outer sheath 812 and the sheath engagement mechanism 876.

[0117] The sheath engagement mechanism 876 can move within the handle 870 between a distal initial position ( Figure 8C shown) and a proximal final position ( Figure 8D shown). The initial position of the sheath engagement mechanism 876 corresponds to the outer sheath 812 circumferentially disposed around at least a portion of the embolization filter 810 and the embolization filter 810 accommodated in a folded configuration. The final position of the sheath engagement mechanism 876 corresponds to the outer sheath 812 longitudinally retracted over the embolization filter 810 and the embolization filter 810 deployed in a self-expanding configuration.

[0118] The sheath engagement mechanism 876 can be selectively operated by the first slider 872. For example, an operator presses the first slider 872 downward with the thumb to unlock the sheath engagement mechanism 876 from the handle 870 so as to move the sheath engagement mechanism 876 from the initial position ( Figure 8C as shown in) to the final position (as Figure 8D shown). The operator moves the first slider 872 proximally with their thumb to retract the outer sheath 812 and expose the embolic filter 810. To fold / restore the embolic filter 810, the operator moves the first slider 872 distally and advances the outer sheath 812 over the embolic filter 810.

[0119] Figure 8C The example of the handle 870 shown in also includes an engagement mechanism 878 that is configured to change the size or diameter of the distal opening 840 of the embolic filter 810 by the movement of the second slider 874. The engagement mechanism 878 includes a top pull member 880 and a bottom pull member 882. The top pull member 880 is coupled to the proximal portion of the outer catheter 858, while the bottom pull member 882 is coupled to the proximal portion of the inner catheter 856 (as Figure 8F shown).

[0120] The engagement mechanism 878 can be in an initial (proximal) position within the handle 870 (as Figure 8C and 8D shown), an intermediate position (as Figure 8E shown) and a final (distal) position ( Figure 8F shown). The initial position of the engagement mechanism 878 corresponds to the embolic filter 810 in a self-expanding configuration where the filter frame 824 is not deflected (or bent). The intermediate position of the engagement mechanism 878 corresponds to the embolic filter 810 in a partially expanded configuration where the filter frame 824 is deflected (or bent) in the longitudinal direction. The final position of the engagement mechanism 878 corresponds to the embolic filter 810 in a fully expanded configuration where the filter frame 824 extends in the radial direction.

[0121] The engagement mechanism 878 can be selectively operated by the second slider 874. For example, when the engagement mechanism 878 is in the initial position (as Figure 8D shown), the user presses the second slider 874 downward. The applied force causes a protrusion (not shown) extending from the second slider 874 to move downward through a hole (not shown) in the top pull member 880 and into a pit (not shown) in the bottom pull member 882.

[0122] In Figure 8E with reference to Figure 8BIn combination, with the second slider 874 depressed and engaged with both the top pull member 880 and the bottom pull member 882, the operator moves the second slider 874 distally with their thumb to advance the outer catheter 858 and the inner catheter (hidden from view) together. The consistent movement of the outer catheter 858 and the inner catheter causes the pusher wire 822 and the top guide 860 to move together (i.e., move consistently). This in turn longitudinally advances the movable portion 830 in the distal direction (forward direction) and expands the distal opening 840 of the embolic filter 810.

[0123] The distal opening 840 continues to expand with the distal movement of the second slider 874 until the engagement mechanism 878 reaches Figure 8E the intermediate position shown. In the intermediate position, the distal opening 840 has a first dimension (e.g., a diameter of about 25 mm), and the second slider 874 is partially disengaged from the engagement mechanism 878. For example, a spring and a ball plunger (not shown) located within the handle 870 lift the protrusion out of the pit of the bottom pull member 882. The second slider 874 is disengaged from the bottom pull member 882 but remains engaged with the top pull member 880. It may be convenient to consider the engagement between the top pull member 880 and the bottom pull member 882 as temporary.

[0124] In Figure 8F combination with reference Figure 8B the operator continues to move the second slider 874 distally to advance the outer catheter 858 further in the distal direction. With the bottom pull member 882 disengaged, the inner catheter 856 and the top guide 860 are fixed in place while the pusher wire 822 advances further in the distal direction. As a result, the length of the movable portion 830 extends radially out from the top guide 860 (i.e., out of the plane of the page) and further expands the distal opening 840 of the embolic filter 810 to the next size (e.g., a diameter of about 30 mm). When the engagement mechanism 878 is in the final position as shown in Figure 8F the distal opening 840 expands to its maximum size (e.g., a diameter of about 40 mm). To retrieve the embolic filter 810, the process described above with reference to Figures 8C - 8F is performed in reverse.

[0125] In some embodiments, the wire of the embolic protection device as described in the present application, such as Figure 1B the pull wire 122 of the embolic protection device 100 or Figure 6B the pusher wire 622 of the embolic protection device 600, comprises a metallic material such as stainless steel. Alternatively, the wire may comprise a plastic material or other suitable material. In some embodiments, the wire is stainless steel coated with polytetrafluoroethylene (PTFE). In the case where the wire is a pull wire, similar to Figure 1BThe pull wire 122, which is flexible but can have sufficient stiffness to deflect (or bend) the embolic filter frame in the proximal direction when the pull wire is retracted in a manner similar to that referenced above Figure 1C and Figure 1D described. In the case where the wire is a push wire, similar to Figure 6B the push wire 622, which is flexible but can have sufficient stiffness to deflect / bend the push wire embolic filter frame in the distal direction when the pull wire is advanced, and to extend the frame in the radial direction when the pull wire is advanced in a manner similar to that referenced above Figures 6D - 6F described.

[0126] In some embodiments, the filter medium (e.g., Figure 1A the filter medium 126 or Figure 6B the filter medium 626) includes a woven mesh, such as a woven nitinol mesh. In some embodiments, the filter medium includes a porous membrane, such as a semi-permeable polyurethane membrane. In other embodiments, the pore size of the filter medium is from about 100 microns to about 150 microns (e.g., about 125 microns).

[0127] In some embodiments, the embolic filter (e.g., Figure 1B the embolic filter 110 or Figure 6B the embolic filter 610) includes an anti-embolism formation coating (e.g., a heparin coating or other coating containing thrombin or platelet inhibitors) to facilitate reducing embolism formation.

[0128] The embolic filter is configured to self-expand into a radially expanded configuration such as shown in Figure 1A the outer sheath 112 or Figure 6A the outer sheath 612, etc., when not restricted or constrained by a deployment device such as Figure 1B and 1C and Figure 6B and Figure 6C etc.

[0129] In some embodiments where the deployment mechanism includes an outer sheath (e.g., Figure 1A the movable outer sheath 112 or Figure 6A the movable outer sheath 612), the outer sheath is configured to be circumferentially disposed around at least a portion of the catheter and the embolic filter (e.g., Figure 1A the catheter 102 and the embolic filter 110 or Figure 6AThe catheter 602 and the embolic filter 610). The outer sheath is configured to contain or house the embolic filter in a folded configuration. The outer sheath is longitudinally movable relative to the catheter and can be longitudinally retracted (i.e., longitudinally moved in the proximal direction) to deploy the embolic filter and longitudinally advanced (i.e., longitudinally moved in the distal direction) to recapture the embolic filter and any embolic material collected by the embolic filter. The embolic filter is configured to self-expand upon longitudinal retraction of the outer sheath.

[0130] In some embodiments, the embolic filter of the embolic protection device described in the present application (e.g., Figure 1A the embolic filter 110 and Figure 6A the embolic filter 610) is configured to be at least partially folded upon longitudinal extension of the outer sheath (e.g., Figure 1A the outer sheath 112 and Figure 6A the outer sheath 612). In these embodiments, the distal opening of the embolic filter (e.g., Figure 1B the distal opening 140 and Figure 6B the distal opening 640) presents a substantially closed configuration to isolate or substantially isolate the filtered material.

[0131] In some embodiments, the catheter of the embolic protection device described in the present application (e.g., Figure 1A the catheter 102 and Figure 6A the catheter 602) may include a flexible material so as to be in a body cavity as further described in the present application (e.g., Figure 9A the body cavity 992 and Figure 12AIt can be manipulated within the body cavity 1292). For example, in some embodiments, the catheter comprises a metal or metal alloy. In other embodiments, the catheter comprises a polymer (such as polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), plastic materials, any combination thereof, etc.). In some embodiments, the catheter comprises a metal-reinforced plastic (such as comprising nitinol, stainless steel, etc.). Other materials are also feasible. In some embodiments, the catheter is substantially free of latex (natural or synthetic), which may cause allergic reactions in some patients. In some embodiments, the catheter comprises a braided-reinforced tubing to facilitate increasing the strength of the catheter. In some embodiments, the catheter comprises a braided catheter shaft, and the braided catheter shaft comprises a layer of braided wire between two layers of the catheter tubing, which can increase the strength of the catheter. In some embodiments, the catheter does not comprise a braided layer, which can increase the flexibility of the catheter. In some embodiments, the catheter comprises a lubricating coating, such as a coating with a low coefficient of friction, to facilitate smoother navigation in a curved vasculature. In some embodiments, the catheter coating has anti-embolism formation properties to facilitate inhibiting embolism formation. In some embodiments, the size (i.e., outer diameter) of the catheter is between about 3 French and about 5 French (between about 2 mm and about 3 mm). Other sizes are also feasible, such as depending on the size of the target body cavity of a particular patient. In some embodiments, the length of the catheter is between approximately 65 centimeters (cm) and approximately 135 cm. Other lengths are also feasible, such as to allow insertion of the catheter into the femoral artery, radial artery, brachial artery, or subclavian artery. The catheter can be manufactured, for example, by extrusion, injection molding, or other suitable processes.

[0132] In some embodiments, the embolization protection device described in the present application may comprise one or more radiopaque marker bands located at the distal portion of the catheter. For example, Figure 1A and Figure 1B the radiopaque marker 106 of the embolization protection device 100 is located at the distal portion 104 of the catheter 102. As another example, Figure 6A and 6B the radiopaque marker 606 of the embolization protection device 600 is located at the distal portion 604 of the catheter 602. When the distal portion presents a generally arcuate shape, the circumferential radiopaque marker band can be visualized to confirm that the distal portion is generally arcuate. In some embodiments, the radiopaque marker band is positioned such that when the distal portion presents its generally arcuate configuration, the marker band is at the farthest point of the catheter, i.e., actually beyond the distal end of the catheter (such as beyond the distal end 116 of the catheter 102 shown in Figure 1A and 1B or beyond the distal end 616 of the catheter 602 shown in Figure 6A and 6B ).

[0133] The radiopaque marker includes a radiopaque material such as platinum, tantalum, tungsten, palladium, and / or iridium. Other radiopaque materials are also feasible. In some embodiments, for example, if the average atomic number is greater than 24 or if the density is greater than about 9.9 g / cm 3 , then the material can be considered radiopaque. In some embodiments, the distal portion of the catheter (such as Figure 1A and 1B the distal portion 104 of the catheter 102 of Figure 6A and 6B the distal portion 604 of the catheter 602 of

[0134] In some embodiments, the outer sheath of the embolic protection device described in the present application includes a hollow tube configured to circumferentially surround at least a portion of the catheter. These outer sheaths are, for example, Figures 1A to 1F the outer sheath 112 of the embolic protection device 100 of Figures 6A - 6G or Figure 1A and Figure 6A the outer sheath 612 of the embolic protection device 600 of

[0135] In some embodiments, the outer sheath extends proximally to the proximal end of the catheter (such as Figure 1A the proximal end 114 of the catheter 102 shown in Figure 6A or

[0136] In some embodiments, the embolic protection device described in the present application may have longitudinally extending grooves (not shown) along its outer surface. For example, Figure 1B the embolic protection device 100 of Figure 6BThe embolic protection device 600 includes longitudinally extending grooves along the catheter 602, along the support catheter 650, or along the deployment mechanism / external sheath 612. In some embodiments, the grooves may extend substantially from the proximal end to the distal end of the embolic protection device. The grooves can be used to guide another catheter device alongside the embolic protection device. For example, the grooves can be used to guide a valve delivery device alongside the embolic protection device and beyond the distal end of the embolic protection device. Advantageously, the second device can track along the groove and extend beyond the embolic protection device while the embolic filter is deployed, such as as Figure 13A shown.

[0137] The device according to the disclosure of the present application may include some or all of the features of the embolic protection devices 100, 200, 300, 400, 500, 600, 700, and 800 shown as Figures 1A - 1F , Figure 2A and 2B , Figures 3A - 3D , Figures 4A - 4C , Figure 5A and 5B , Figures 6A - 6G , Figures 7A - 7C and Figures 8A - 8F shown and described in various combinations in the present application.

[0138] III. Method of Capturing Embolic Debris

[0139] Another aspect of the present invention provides a method 900 of capturing embolic debris during a closed-heart medical procedure (such as an aortic valve replacement procedure) using the embolic protection device of the present invention (such as the embolic protection devices 100, 200, 300, 400, or 500 described in the present application), as shown in a step-by-step manner in Figures 9A - 9E .

[0140] Referring to Figure 9A , in one embodiment, a guide wire 990 is percutaneously inserted into a body cavity 992 of a patient, such as the femoral artery, radial artery, brachial artery, or subclavian artery, and navigated to a desired anatomical location, such as the ascending aorta. The guide wire 990 can be a J-shaped wire having a diameter of approximately 0.035 inches (approximately 0.089 cm). Other types and sizes of wires 990 useful for this method are also feasible.

[0141] In some embodiments, the proximal end of the guide wire 990 is inserted into an opening at the distal end 116 of the catheter 102. When the guide wire 990 is within the lumen 118 of the distal portion 104 of the catheter 102, the distal portion 104 of the catheter is straightened or assumes the curved portion of the guide wire 990. As Figure 9AAs shown, the distal end 116 of the catheter 102 is inserted into the body cavity 992 by tracking the inner lumen 118 of the catheter 102 over the guide wire 990. The outer diameter of the guide wire 990 is smaller than the inner diameter of the embolization protection device 100, such that the embolization protection device 100 can be tracked over the guide wire 990. The inner surface of the inner lumen 118 and / or the outer surface of the guide wire 990 may include a lubricious coating to reduce friction during tracking. When the catheter 102 is inserted into and navigated within a patient, the guide wire 990 keeps the distal portion 104 of the catheter 102 substantially straight (e.g., in a generally arcuate state).

[0142] The radiopaque marker 106 is used to visualize and locate the distal portion 104 of the catheter 102 during tracking. The guide wire 990 is retracted, i.e., longitudinally moved in the proximal direction a sufficient distance to allow the distal portion 104 of the catheter 102 to assume a generally arcuate shape, as Figure 9B shown. The distal portion 104 of the catheter 102 is positioned at a desired anatomical landmark, e.g., the inferior border of the non-coronary cusp of the aortic valve. When the distal portion 104 assumes its generally arcuate shape, the radiopaque marker 106 is located on the most distal portion of the distal portion 104. In some embodiments, the distal portion 104 of the catheter 102 may be injected with a radiopaque material such that the entire distal portion 104 can be seen using imaging techniques.

[0143] In some embodiments of the method, the proximal end 114 of the catheter 102 is connected to a contrast injector, and contrast is injected into the inner lumen 118 of the catheter 102, e.g., to visualize the anatomy around the device 100. The contrast material exits the inner lumen 118 of the catheter 102 through an opening at the distal end 116 of the catheter 102 and / or through one or more apertures 108 in the sidewall of the catheter 102. Injecting contrast can aid in visualizing and locating the catheter 102.

[0144] In some embodiments, a second guide wire is percutaneously inserted into a second body cavity (e.g., another femoral artery), and a second catheter is tracked over the second guide wire. The second catheter may carry a medical device or instrument, such as a replacement valve, valve repair system, or radiofrequency ablation system. Once the second catheter and the associated device or instrument are properly positioned, the outer sheath 112 of the catheter 102 is longitudinally retracted proximally, such that the embolization filter 110 assumes an expanded deployed configuration as Figure 9C shown.

[0145] Next, the pull wire 122 can be retracted to bend the frame 124 of the embolization filter 110. The pull wire 122 bends the frame 124 in the proximal longitudinal direction and laterally outward. In the fully bent configuration (i.e., when the pull wire is fully retracted), as Figure 9D and 9EAs shown, the distal opening 140 of the embolic filter 110 can be substantially perpendicular to the catheter 102 and can laterally span the body cavity 992, generally perpendicular to the longitudinal axis of the body cavity 992. The fully curved configuration can engage the body cavity 992 so as to capture embolic debris 994 within the embolic filter 110 without allowing the embolic debris to propagate around the outside of the embolic filter 110. The second guide wire and / or the second catheter can also be positioned after the embolic filter 110 is deployed. The distal opening 140 of the embolic filter 110 is located in the ascending aorta so that blood flows through the filter before flowing into the carotid artery or the descending aorta. In some embodiments, when the embolic filter 110 is deployed, the catheter 102 is placed against the inner lumen wall to stabilize the catheter 102. Then, the procedure can be performed and embolic debris that breaks off or enters the bloodstream during the procedure is captured by the embolic filter 110.

[0146] After the procedure, the pull wire 122 is advanced and the outer sheath 112 is advanced distally longitudinally to recapture the embolic filter 110, return the frame to the non-curved configuration, return the embolic filter 110 to the collapsed configuration, and capture any embolic debris 994 contained within the embolic filter 110 (see Figure 9E ). The second catheter and the catheter 102 can then be withdrawn from the patient. The catheter 102 can be retracted over the guide wire 990 or without straightening the distal portion 104 of the catheter 102 since the arcuate shape of the distal portion 104 is non-damaging to the blood vessel.

[0147] In some embodiments, the procedure performed is a heart valve replacement procedure, such as an aortic valve replacement procedure. As described in the present application and as Figures 9A - 9EAs shown, the embolic protection device 100 is introduced into the patient and navigated to the aortic valve. The radiopaque marker 106 helps to delineate the lower border of the non-coronary cusp to help correctly place the percutaneously implanted replacement aortic valve. Once the catheter 102 is positioned, the second guide wire can be percutaneously inserted into the second body cavity and navigated to the level of the ascending aorta or the left ventricle. The balloon can track over the second guide wire to the aortic valve. Then, the outer sheath 112 is retracted to deploy the embolic filter 110, and the pull wire 122 is retracted to bend the frame 124 into a curved configuration. Balloon expansion of the valve can then be performed, and the embolic filter 110 captures embolic debris 994 that is dislodged in the bloodstream during surgery or otherwise. After the balloon is pre-expanded, the pull wire 122 is advanced and the outer sheath 112 is advanced to recapture the embolic filter 110 and any embolic debris 994 contained in the embolic filter 110. The balloon is removed, and a second catheter with the valve prosthesis is advanced to the level of the ascending aorta by tracking the catheter over the second guide wire. The outer sheath 112 is retracted again to redeploy the embolic filter 110, and the pull wire 122 is retracted again. The radiopaque marker 106 allows the user to correctly place the valve prosthesis, for example, about 4 mm to about 6 mm below the lower border of the non-coronary cusp. After the procedure is completed, the pull wire 122 is advanced and the outer sheath 112 is advanced to recapture the embolic filter 110 and any captured embolic debris 994, and the catheter is removed from the body. In some embodiments, the second catheter can be removed before the embolic filter 110 and embolic debris 994 are recaptured.

[0148] In some embodiments, the surgery is a heart valve repair surgery. The methods described herein may also be applied to mitral valve repair or replacement surgery. In some embodiments, the surgery is a radiofrequency ablation surgery, such as to treat atrial fibrillation. In some embodiments, the surgery is a catheterization surgery or a structural heart surgery.

[0149] In some embodiments, a method of capturing embolic debris as described herein may include inserting a second catheter device into the same blood vessel as the embolic protection device. The second catheter device may be inserted behind the embolic protection device and may follow a longitudinal groove in an outer surface of the embolic protection device. For example, the valve delivery catheter device may be guided alongside the embolic protection device and beyond the distal end of the embolic protection device by having the valve delivery device follow the groove. Advantageously, the second device may follow the groove and beyond the embolic protection device while the embolic filter is deployed, for example, as described above. Figure 13A As shown.

[0150] Figure 10Another embodiment of method 1000 for deflecting and capturing embolic debris using an embolic protection device 1001 during a medical procedure is shown. The embolic protection device 1001 is similar to the embolic protection device 300 described in Figures 3A - 3D but has an intermediate tube 1030. The embolic protection device 1001 also includes an embolic filter 1010 that is movably coupled to a catheter 1002 by means of a frame 1024 and is longitudinally movable relative to the catheter 1002. As shown, the catheter 1002 is at least partially surrounded by a support catheter 1050 that terminates in a head 1052 adjacent to the distal portion 1004 of the catheter 1002. The embolic filter 1010 is coupled to the intermediate tube 1030 that at least partially circumferentially surrounds the support catheter 1050. The intermediate tube 1030 is longitudinally movable relative to the catheter 1002.

[0151] The embolic protection device 1001 also includes an outer sheath (not shown) that is configured to at least partially circumferentially surround the catheter 1002 / support catheter 1050 and the intermediate tube 1030. The intermediate tube 1030 and the outer sheath can be moved simultaneously and independently. The longitudinal position of the embolic filter 1010 relative to the catheter 1002 can be adjusted when the embolic filter 1010 is in a folded configuration or an expanded configuration that is fully or partially deployed.

[0152] Method 1000 includes using the embolic protection device 1001 to capture emboli in a manner similar to method 900 described above with reference to Figures 9A to 9E For example, the distal end 1016 of the catheter 1002 is inserted into a patient's body cavity 1080 by tracking the lumen 1018 of the catheter 1002 over a guide wire that has been previously percutaneously inserted into the body cavity 1080. When the catheter 1002 is inserted into the patient and navigated within the patient, the guide wire keeps the distal portion 1004 of the catheter 1002 substantially straight (e.g., in a generally arcuate state). A radiopaque marker 1006 is used to visualize and locate the distal portion 1004 of the catheter 1002 during tracking. Visualization can also be achieved by perfusing an imaging dye or contrast agent through an orifice 1008 in the distal portion 1004 of the catheter 1002. Once positioned at a desired anatomical landmark (e.g., at the inferior border of the non-coronary cusp of the aortic valve), the guide wire is retracted a sufficient distance to allow the distal portion 1004 of the catheter 1002 to assume a generally arcuate shape, as Figure 10 shown.

[0153] The longitudinal position of the embolization filter 1010 within the body cavity 1080 can be adjusted by simultaneously moving the intermediate tube 1030 and the outer sheath. When the embolization filter 1010 is in the desired longitudinal position within the body cavity 1080, the intermediate tube 1030 is held stationary while the outer sheath is retracted to deploy the embolization filter 1010. Next, the pull wire 1022 is retracted to bend the frame 1024 and open the embolization filter 1010 to capture the embolus.

[0154] Method 1000 also includes deflecting the embolus. The embolus protection device 1001 also includes a deflector 1060 similar to Figures 4A to 4C the deflector shown. Once the embolus protection device 1001 is in place (as described above), the deflector 1060 is deployed from the outer sheath to cover the brachiocephalic and left common carotid arteries. In some patients, the deflector 1060 may also cover the left subclavian artery. During subsequent medical procedures, the deflector 1060 can prevent emboli from entering the carotid arteries, and the embolization filter 1010 can capture the emboli before they are propagated to other parts of the patient's body by the deflector 1060. Method 1000 can also be performed using a variety of other embolus protection devices (such as the embolus protection device described in this application) and deflector devices that can vary in their configuration and the manner in which they are introduced into the body and navigated to the aortic arch.

[0155] Figure 11 Another embodiment of a method 1100 for deflecting and capturing embolic debris is shown. The embolus protection device 1101 includes a catheter 1102 (such as a pigtail catheter) having a radiopaque marker 1106 and an embolization filter 1110 disposed around the catheter 1102, the latter being similar to Figures 1A - 1F the embolization filter 110 shown and described in this application. As shown, the catheter 1102 is partially surrounded by a support catheter 1150 that terminates in a head 1152 adjacent to the distal portion 1104 of the catheter 1102.

[0156] Method 1100 includes in a manner similar to that described above with reference to Figures 9A - 9EThe embolism is captured using the embolism protection device 1101 in the manner of the described method 900. For example, the distal end 1116 of the catheter 1102 is inserted into the patient's body cavity 1180 by tracking the lumen 1118 of the catheter 1102 along a guide wire that has been previously percutaneously inserted into the body cavity 1180. When the catheter 1102 is inserted into and navigated within the patient, the guide wire keeps the distal portion 1104 of the catheter 1102 substantially straight (e.g., in a generally arcuate state). The radiopaque marker 1106 is used to visualize and locate the distal portion 1104 of the catheter 1102 during tracking. Visualization can also be achieved by perfusing an imaging dye or a contrast agent through the orifice 1108 in the distal portion 1104 of the catheter 1102.

[0157] Once positioned at the desired anatomical landmark (e.g., at the lower boundary of the non-coronary cusp of the aortic valve), the guide wire is retracted a sufficient distance to allow the distal portion 1104 of the catheter 1102 to assume a generally arcuate shape, as Figure 11 shown. The outer sheath (not shown) of the catheter 1102 is retracted proximally along the longitudinal direction, thereby allowing the embolism filter 1110 to assume an expanded deployed configuration, as Figure 11 shown. Next, the pull wire 1122 is retracted to bend the frame 1124 and open the embolism filter 1110 to capture the embolism.

[0158] Method 1100 also includes deflecting the embolism with a deflector 1160. As shown, the deflector 1160 is mounted on a shaft 1162 and is contained within a introducer 1168 during insertion. The introducer 1168 is introduced into the patient's body through an artery (e.g., the right radial artery) and navigated to the aortic arch via the brachiocephalic artery. Once in place, the deflector 1160 is deployed from the introducer 1168 and pulled back to cover the brachiocephalic artery and the left common carotid artery. In some patients, the deflector 1160 may also cover the left subclavian artery. In some embodiments, the deflector 1160 can be introduced and deployed before the catheter 1102 is guided to the aortic arch. During subsequent medical procedures, the deflector 1160 can prevent emboli from entering the carotid artery, and the embolism filter 1110 can capture the emboli before they spread to other parts of the patient's body deflected by the deflector 1160. The method 1100 can also be performed with various other embolism protection devices and deflector devices as described in this application, which may vary in configuration and the manner in which they are introduced into the body and guided to the aortic arch.

[0159] Another aspect of the present invention provides a method for capturing embolic debris during closed heart surgery, the method comprising inserting a distal end of an embolic protection device into a body cavity, the embolic protection device comprising: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to accommodate a guide wire and a distal portion of the catheter, the distal portion assuming a generally arcuate shape that is at least semicircular when the guide wire is at least partially longitudinally retracted; a self-expanding embolic filter disposed proximal to the distal portion of the catheter, wherein the embolic filter comprises A method of providing a catheter having a plurality of embolic filters and a plurality of embolic filters for use in a plurality of patients with the present invention is provided. The method further comprises: providing a catheter having a plurality of embolic filters for use in a plurality of patients with the present invention being provided with ...

[0160] Some embodiments further include at least partially longitudinally retracting the guidewire from the catheter lumen such that a distal portion of the catheter assumes a generally arcuate shape that is at least semi-circular.

[0161] In some embodiments, the distal portion of the catheter includes a radiopaque marker; and the method further includes positioning the catheter by visualizing the radiopaque marker using an imaging technique.

[0162] Some embodiments include at least partially longitudinally retracting the deployment mechanism and allowing the self-expanding embolic filter to assume an expanded, deployed configuration.

[0163] Some embodiments include longitudinally retracting the wires, thereby bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, wherein an opening defined by the frame generally spans the body cavity.

[0164] Some embodiments include longitudinally retracting the wire to a proximal position, thereby bending the frame so that an opening of the filter defined by the frame is generally perpendicular to a longitudinal direction of the catheter, wherein the opening defined by the frame generally spans the body cavity.

[0165] In some embodiments, the embolic filter is movably coupled to the catheter and is longitudinally movable relative to the catheter; and the method includes moving the embolic filter longitudinally relative to the catheter.

[0166] In some embodiments, the embolic protection device includes a self-expanding deflector coupled to the catheter proximal to the distal portion; and the method includes deploying the self-expanding deflector to direct the embolic debris toward the embolic filter.

[0167] In some embodiments, the deployment mechanism is a sheath disposed circumferentially around at least a portion of the catheter.

[0168] In some embodiments, the distal portion of the catheter includes one or more ports in communication with the lumen of the catheter; and the method further includes infusing the fluid into the body cavity through the one or more ports.

[0169] In some embodiments, the embolic protection device comprises a longitudinal groove along an outer surface of the embolic protection device; and the method further comprises inserting the second catheter device alongside the embolic protection device by tracking the second catheter device along the groove.

[0170] In some embodiments, the second catheter device is advanced through the embolic filter of the embolic protection device when the embolic filter is in the deployed configuration.

[0171] Another aspect of the present invention provides a method for capturing embolic debris during closed heart surgery, the method comprising inserting a distal end of an embolic protection device into a body cavity, the embolic protection device comprising: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to accommodate a guide wire and a distal portion of the catheter that assumes a generally arcuate shape that is at least semicircular when the guide wire is at least partially retracted longitudinally; a self-expanding embolic filter disposed around the distal portion of the catheter, wherein the embolic filter comprises a The invention relates to a self-expanding filter comprising a frame that defines an opening of the embolic filter; a deployment mechanism that is arranged around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, the deployment mechanism is configured to contain the embolic filter in a folded configuration, and the embolic filter is configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire that is connected to the self-expanding filter frame, wherein the wire is movable longitudinally and, when it is longitudinally retracted, bends the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter so that the opening of the embolic filter generally faces the distal end of the catheter.

[0172] The method also includes tracking the lumen of the catheter over a guidewire inserted percutaneously into the body cavity and longitudinally retracting the guidewire at least partially from the lumen of the catheter so that the distal portion of the catheter assumes a generally arcuate shape that is at least semicircular when the guidewire is retracted from the distal portion of the catheter. The method also includes longitudinally retracting the deployment mechanism and deploying the self-expanding embolic filter. The method also includes longitudinally retracting the wire and bending the embolic filter frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter.

[0173] Another aspect of the present invention provides a Figures 12A - 12DMethod 1200, as shown step by step, which uses an embolic protection device of the present invention (such as embolic protection devices 600, 700, or 800 as described in this application) to capture embolic debris during a closed-heart medical procedure (such as an aortic valve replacement procedure).

[0174] Reference Figure 12A , in one embodiment, a guide wire 1290 is percutaneously inserted into a patient's body cavity 1292, such as the femoral artery, radial artery, brachial artery, or subclavian artery, and navigated to a desired anatomical location, such as the ascending aorta. The guide wire 1290 can be a J-shaped wire having a diameter of approximately 0.035 inches (approximately 0.089 cm). Other types and sizes of guide wires useful for this method are also feasible.

[0175] In other embodiments, the proximal end of the guide wire 1290 is inserted into an opening at the distal end 616 of the catheter 602. When the guide wire 1290 is within the lumen 618 at the distal portion 604 of the catheter 602, the distal portion 604 of the catheter is straightened or assumes the curved portion of the guide wire 1290. The distal end 616 of the catheter 602 is inserted into the body cavity 1292 by tracking the lumen 618 of the catheter 602 over the guide wire 1290, as Figure 12A shown. The outer diameter of the guide wire 1290 is less than the inner diameter of the embolic protection device 600 such that the embolic protection device 600 can track over the guide wire 1290. The inner surface of the lumen 618 and / or the outer surface of the guide wire 1290 can include a lubricious coating to reduce friction during the tracking process. When the catheter 602 is inserted into and navigated within the patient, the guide wire 1290 keeps the distal portion 604 of the catheter 602 substantially straight (e.g., in a generally arcuate state).

[0176] A radiopaque marker 606 is used to visualize and position the distal portion 604 of the catheter 602 during tracking. The guide wire 1290 is retracted, i.e., longitudinally moved in the proximal direction a sufficient distance to allow the distal portion 604 of the catheter 602 to assume a generally arcuate shape, as Figure 12B shown. The distal portion 604 of the catheter 602 is positioned at a desired anatomical landmark, e.g., at the lower boundary of the non-coronary cusp of the aortic valve. When the distal portion 604 assumes its generally arcuate shape, the radiopaque marker 606 is at the most distal portion of the distal portion 604. In some embodiments, the distal portion 604 of the catheter 602 can be injected with a radiopaque material such that the entire distal portion 604 can be seen using imaging techniques.

[0177] In other embodiments of the method, the proximal end 614 of the catheter 602 is connected to a contrast injector, and contrast is injected into the lumen 618 of the catheter 602, for example to visualize the anatomy around the embolic protection device 600. The contrast material exits the lumen 618 through an opening at the distal end 616 of the catheter 602 and / or through one or more apertures 608 in the sidewall of the catheter 602. Injecting the contrast material can aid in visualizing and positioning the catheter 602.

[0178] In other embodiments, a second guidewire is percutaneously inserted into a second body cavity, such as another femoral artery, and a second catheter is tracked over the second guidewire. The second catheter may carry a medical device or instrument, such as a replacement valve, valve repair system, or radiofrequency ablation system. Once the second catheter and associated device or instrument are properly positioned, the outer sheath 612 is longitudinally retracted in the proximal direction, thereby allowing the embolic filter 610 to assume a self-expanding deployed configuration, as Figure 12C shown.

[0179] Next, the pusher wire 622 can be advanced to bend the filter frame of the embolic filter 610. The pusher wire and filter frame are not shown in Figures 12A to 12D but can be seen in Figures 6B - 6F as the pusher wire 622 and frame 624, respectively. The pusher wire causes the filter frame to bend in the distal longitudinal direction and laterally outward. As Figure 12D shown, in the bent configuration (i.e., the pusher wire is advanced in the distal direction), as Figure 12D shown in, the distal opening 640 of the embolic filter 610 can be generally perpendicular to the catheter 602 and can span the body cavity 1292 laterally, generally perpendicular to the longitudinal axis of the body cavity 1292. To accommodate the dimensions of the body cavity 1292, the pusher wire can be further advanced to extend the frame in the radial direction and further expand the embolic filter 610.

[0180] The bent configuration can engage the body cavity 1292, thereby capturing embolic debris 1294 in the embolic filter 610 without allowing the embolic debris to propagate around the outside of the embolic filter 610. The second guidewire and / or second catheter can also be positioned after the embolic filter 610 is deployed. The distal opening 640 of the embolic filter 610 is located in the ascending aorta such that blood flows through the embolic filter 610 before entering the carotid artery or descending aorta. In some embodiments, when the embolic filter 610 is deployed, the catheter 602 is placed against the lumen wall to stabilize the catheter 602. The procedure can then be performed, and embolic debris 1294 shed or otherwise present in the blood stream is captured by the embolic filter 610 during the procedure.

[0181] After the procedure, the pusher wire 622 is retracted and the outer sheath 612 is advanced longitudinally and distally to recapture the embolic filter 610, returning the filter frame to the unbent configuration and the embolic filter 610 to the collapsed configuration. And any embolic debris 1294 contained within the embolic filter 610 is also captured (see Figure 12D ). The second catheter and catheter 602 can then be withdrawn from the patient. Because of the arcuate shape of the distal portion 604 being non-invasive to the blood vessel, the catheter 602 can be withdrawn over the guide wire 1290 or without straightening the distal portion 604 of the catheter 602.

[0182] In other embodiments, the procedure performed is a heart valve replacement procedure, such as an aortic valve replacement procedure. The embolic protection device 600 is introduced into the patient and navigated to the aortic valve, as described in this application and as Figures 12A - 12D shown. The radiopaque marker 606 helps to delineate the lower boundary of the non-coronary leaflet tip to assist in the proper placement of the percutaneously implanted replacement aortic valve. Once the catheter 602 is positioned, a second guide wire can be percutaneously inserted into the second body cavity and navigated to the level of the ascending aorta or the left ventricle. The balloon can then be tracked over the second guide wire to the aortic valve. Then, the outer sheath 612 is retracted to deploy the embolic filter 610, and the pusher wire 622 is advanced to bend the frame 624 into the bent configuration. And, if engagement of the in vivo body cavity 1292 is desired, the pusher wire 622 can be further advanced to extend the frame 624 to the extended configuration. The balloon inflation of the valve can then be performed, and the embolic filter 610 captures any embolic debris 1294 shed during or otherwise in the blood flow during the procedure. After the balloon pre-expansion, the pusher wire 622 is retracted and the outer sheath 612 is advanced to recapture the embolic filter 610 and any embolic debris 1294 contained within the embolic filter 610. The balloon is removed, and the second catheter carrying the valve prosthesis is advanced to the level of the ascending aorta by tracking the catheter over the second guide wire. The outer sheath 612 is retracted again to redeploy the embolic filter 610, and the pusher wire 622 is advanced again. The radiopaque marker 606 allows the user to properly place the valve prosthesis, such as about 4 mm to about 6 mm below the lower boundary of the non-coronary leaflet tip. After the procedure is completed, the pusher wire 622 is retracted and the outer sheath 612 is advanced to recapture the embolic filter 610 and any captured embolic debris 1294, and the catheter is removed from the body. In some embodiments, the second catheter can be removed before recapturing the embolic filter 610 and the embolic debris 1294.

[0183] In other embodiments, the procedure is a heart valve repair procedure. The method described in the present application may also be applicable to mitral valve repair or replacement procedures. In some embodiments, the procedure is a radiofrequency ablation procedure, such as to treat atrial fibrillation. In some embodiments, the procedure is a catheterization procedure or a structural heart procedure.

[0184] In other embodiments, a method of capturing embolic debris as described in the present application may include inserting a second catheter device through the same blood vessel as the embolic protection device. The second catheter device may be inserted after the embolic protection device and may track along a longitudinal groove in the outer surface of the embolic protection device. For example, by tracking a valve delivery device along the groove, a valve delivery catheter device may be guided alongside the embolic protection device and beyond the distal end of the embolic protection device. Advantageously, the second device may track along the groove and beyond the embolic protection device while the embolic filter is deployed, for example as Figure 13A shown.

[0185] Another aspect of the present invention provides a method of capturing embolic debris during a closed-heart procedure, the method including inserting a distal end of an embolic protection device into a body cavity, the embolic protection device including: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion presenting a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolic filter disposed proximal to the distal portion of the catheter, wherein the embolic filter includes a frame and the frame defines an opening of the embolic filter; a deployment mechanism disposed around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism being configured to contain the embolic filter in a collapsed configuration and the embolic filter being configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire coupled to the embolic filter frame, wherein the wire is longitudinally movable relative to the catheter, the wire being configured to, when longitudinally advanced in a distal direction to a first position, cause the frame to bend longitudinally towards the distal end of the catheter and bend laterally outwardly from the catheter such that the opening of the embolic filter generally faces the distal end of the catheter and expands to a first diameter, and when longitudinally advanced distally in a distal direction to a second position further than the first position, cause the frame to extend radially outwardly from the catheter such that the opening of the embolic filter expands to a second diameter greater than the first diameter. The method further includes tracking the lumen of the catheter along a guide wire inserted percutaneously into the body cavity.

[0186] Other embodiments further include at least partially longitudinally retracting the guide wire from the lumen of the catheter such that the distal portion of the catheter presents a generally arcuate shape that is at least semi-circular.

[0187] In other embodiments, the distal portion of the catheter includes a radiopaque marker; and the method further includes positioning the catheter by visualizing the radiopaque marker using an imaging technique.

[0188] Other embodiments include at least partially longitudinally retracting the deployment mechanism and allowing the self-expanding embolic filter to assume the expanded deployed configuration.

[0189] Other embodiments include advancing the wire longitudinally, thereby bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, wherein an opening defined by the frame generally spans the body cavity.

[0190] Other embodiments include advancing the wire longitudinally to a first position, thereby bending the frame longitudinally toward a distal end of the catheter and laterally outward from the catheter and expanding the opening of the embolic filter to substantially span a first diameter of the body lumen.

[0191] Other embodiments include advancing the wire longitudinally and distally to a second position distal to the first position, thereby extending the frame radially outward from the catheter and expanding the opening of the embolic filter to a second diameter greater than the first diameter that generally spans the body lumen.

[0192] In other embodiments, the deployment mechanism is a sheath disposed circumferentially around at least a portion of the catheter.

[0193] In other embodiments, the distal portion of the catheter includes one or more ports in communication with the lumen of the catheter; and the method further includes infusing the fluid into the body cavity through the one or more ports.

[0194] In other embodiments, the embolic protection device includes a longitudinal groove along an outer surface of the embolic protection device; and the method further includes inserting the second catheter device alongside the embolic protection device by tracking the second catheter device along the groove.

[0195] In other embodiments, the second catheter device is advanced through the embolic filter of the embolic protection device when the embolic filter is in the deployed configuration.

[0196] Another aspect of the present invention provides a method for capturing embolic debris during a closed-heart surgery, the method comprising inserting a distal end of an embolic protection device into a body cavity, the embolic protection device comprising: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to accommodate a guide wire and a distal portion of the catheter, the distal portion presenting a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolic filter disposed proximal to the distal portion of the catheter, wherein the embolic filter comprises a frame, and the frame defines an opening of the embolic filter; a deployment mechanism disposed around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism is configured to contain the embolic filter in a folded configuration, and the embolic filter is configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire coupled to the self-expanding filter frame, wherein the wire is longitudinally movable.

[0197] The method further comprises tracking the lumen of the catheter over a guide wire inserted percutaneously into the body cavity and at least partially longitudinally retracting the guide wire from the lumen of the catheter so that the distal portion of the catheter presents a generally arcuate shape that is at least semi-circular when the guide wire is retracted from the distal portion of the catheter. The method further comprises longitudinally retracting the deployment mechanism and deploying the self-expanding embolic filter. The method further comprises longitudinally advancing the wire in a distal direction to a first position, thereby bending the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter and expanding the opening of the embolic filter to a first diameter.

[0198] IV. Examples

[0199] Example 1: Cadaver model

[0200] Reference Figure 13A and 13B , the embolic protection device (EPD-1) of the present invention was tested in a human cadaver model to visually evaluate the ability of the device to cover all cerebral blood vessels with an embolic filter when the intravascular device and EPD-1 were passed side by side through the aorta. In Figure 13A and 13B , the photos, EPD-1 was deployed and covered the openings of the cerebral blood vessels of the cadaver, while the TAVR delivery system passed over the filter. In Figure 13A , the TAVR delivery system tracked along the longitudinal groove on the outer surface of the EPD-1 catheter. In Figure 13B , the TAVR delivery system tracked outside the groove of the EPD-1 catheter.

[0201] Example 2: Clinical study

[0202] Reference Figure 14 and Figures 15A to 15J, the safety and performance of an embolic protection device ("EPD-1") according to the present invention were evaluated during transcatheter aortic valve replacement (TAVR) procedures in human subjects. The primary objective was to evaluate the performance and therapeutic effect of using EPD-1 during TAVR with respect to the surgically related cerebral embolic burden determined by diffusion-weighted magnetic resonance imaging (DW-MRI). The secondary objective was to analyze the safety and type of debris captured from the EPD-1 filter after TAVR.

[0203] The study was designed as a multicenter non-randomized clinical trial involving up to 5 clinical sites to evaluate the performance and therapeutic effect of using EPD-1 during TAVR with respect to surgically related silent ischemic injury and cerebral embolic burden determined by DW-MRI studies performed before and after the procedure. The secondary objective was to analyze the safety and type of debris captured from the EPD-1 filter after TAVR. The potential risk of neurological impairment and stroke was evaluated based on pre- and post-operative neurological assessments. The study population included up to thirty (30) subjects with severe native aortic valve stenosis who met commercially recognized TAVR indications and inclusion / exclusion criteria.

[0204] Primary test objectives: 1) Device performance: defined as successful insertion, placement, and removal of EPD-1. Device performance was evaluated during and after the first TAVR procedure. 2) Reduction of acute cerebral embolism after TAVR, defined as the number and volume of brain injuries detected by DW MRI 2 - 5 days after TAVR compared to baseline.

[0205] Secondary test objectives: 1) The ratio of major adverse cardiac and cerebrovascular events 30 days after the first TAVR procedure compared to historical data. Major adverse cardiac and cerebrovascular events (MACCE) were defined as: all-cause mortality; all strokes (large, small, TIA); acute kidney injury (grade 3). 2) Clinical assessment of the neurological status of the subjects using the NIH Stroke Scale before and after the first procedure.

[0206] Eleven subjects participated in a multicenter non-randomized prospective trial study. The performance characteristics of EPD-1 were evaluated after the procedure and scored on a 5-point scale (1 being unacceptable and 5 being excellent). The average performance of all patients for all characteristics of EPD-1 was 4.8 at clinical site 1 and 3.4 at clinical site 2. The average performance scores for the performance of EPD-1 for each evaluated characteristic (at each clinical site) are shown in Figure 14 the bar graph. The characteristics scored were: vascular access, tracking, use of the sheath and deployment button, positioning, re-sheathing, removal, visualization during angiography, deployment, positioning, repositioning, retrieval, stability, in-situ visibility, ease of deployment, and ease of sheathing.

[0207] The preoperative to postoperative aortic gradient measurements decreased by an average of 86.4% in all eleven (11) subjects, confirming the success of TAVR treatment.

[0208] All subjects underwent DW-MRI examinations before and after the procedure, and the image evaluations were consistent with the identification of certain ischemic lesions. MRI was performed at the baseline and pre-discharge (2 - 5 days) visits of eleven (11) subjects who underwent transcatheter aortic valve replacement (TAVR) procedures at each of the two clinical sites. The MRI protocol consisted of the following sequences: axial DWI, axial FLAIR, and 3D T1-weighted IR-GRE. DWI contrast is sensitive to water molecules and helps localize and quantify fresh lesions. The total number of lesions, lesion location, size, and volume were evaluated, and the total lesion volume was analyzed. Figures 15A - 15J DW-MRI images of the brains of three (3) representative human subjects (001 - 05, 001 - 06, and 002 - 01) are shown.

[0209] A median number of 6 lesions and a median lesion volume of 193.9 mm were observed in eleven (11) subjects 3 . Table 1 details the lesions by location. These results indicate that the number and volume of lesions were lower compared to historical control groups and clinical trials involving cleared and investigational embolic protection devices.

[0210] Table 1: Brain lesions by location for all patients (clinical sites 1 and 2) in the clinical study.

[0211]

[0212] Table 2 provides a detailed comparison of the number and volume of lesions between the clinical study of Example 2 and the clinical studies of comparable devices. These results indicate that protection with EPD-1 can reduce the number of ischemic lesions or reduce the volume of lesions, thus supporting the utility of the procedure.

[0213] Table 2: Comparison of EPD-1 performance with the performance of cleared and investigational devices.

[0214]

[0215] Between these studies, the time points at which MRI was performed varied. In Example 2, DW-MRI was performed within 48 hours after surgery for all patients. For the other reference studies, imaging was performed at longer time points. Since it is known that the appearance of high intensities during DW-MRI imaging develops over time, these other reference studies may have observed larger lesion volumes if DW-MRI had been performed within 48 hours after surgery. However, in terms of reducing the acute cerebral embolism burden, EPD-1 was superior to the reference comparable devices. Although the number of lesions increased in 3 patients, they were considered outliers since the filter was recaptured and the TAVR device was post-expanded. During these outlier surgeries, due to the small aortic anatomy, the operator was concerned about the interaction of the balloon catheter with the filter frame. This typically led to the release of debris.

[0216] EPD-1 captured emboli in all procedures. In Figure 16A and 16B photos of two examples of the captured emboli are shown. Figure 16A The photo of Figure 16B shows an embolus captured by EPD-1 of Example 2. The photo of Figure 16B shows the actual pathological finding of a 4.6 mm collagen fragment captured within the EPD-1 filter during a TAVR procedure. The neurological evaluations performed on all patients using NIHSS at discharge and 30 days after surgery showed that all patients' scores remained at baseline levels except for one patient who developed limb ataxia. No serious adverse events were recorded. The debris captured by the embolic filter of EPD-1 included collagen, fibrin, emboli, and calcium.

[0217] A summary of the test subjects is shown in Table 3.

[0218] Table 3: Summary of the test subjects from the clinical study of Example 2.

[0219]

[0220] Other embodiments

[0221] It should be understood that although the present invention has been described in connection with the detailed description of the invention, the foregoing description is intended to illustrate rather than limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the appended claims.

[0222] Those of ordinary skill in the art will understand that the specific apparatus and processes illustrated in the figures and described in this specification are merely exemplary embodiments of the inventive concepts defined in the appended claims. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed in this application should not be considered restrictive unless the claims expressly state otherwise. It should also be understood that the construction of the described invention and other components is not limited to any particular material. Unless otherwise described in this application, other example embodiments of the invention disclosed in this application may be formed of a variety of materials.

[0223] Changes and modifications to the embodiments specifically described may be made without departing from the principles of the invention, which are defined only by the scope of the appended claims and are interpreted in accordance with the principles of patent law, including the doctrine of equivalents.

Claims

1. An embolic protection device, comprising: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along a longitudinal axis of the catheter, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion presenting a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolic filter disposed around the catheter proximal to the distal portion, wherein the embolic filter includes a frame, and the frame defines an opening of the embolic filter; a deployment mechanism disposed around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism is configured to contain the embolic filter in a collapsed configuration, and the embolic filter is configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire coupled to the frame of the embolic filter, wherein the wire is longitudinally movable and is configured to bend the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter when longitudinally retracted, such that the opening of the embolic filter generally faces the distal end of the catheter.

2. The embolic protection device according to claim 1, wherein the wire is coupled to the frame at a distal connection.

3. The embolic protection device according to claim 1 or 2, wherein the wire is configured to bend the frame when longitudinally retracted to a proximal position such that the opening of the embolic filter defined by the frame is generally perpendicular to the longitudinal axis of the catheter.

4. The embolic protection device according to any one of claims 1 to 3, wherein the wire is configured to position the frame when longitudinally advanced to a distal position such that the opening of the embolic filter defined by the frame is generally parallel to the longitudinal axis of the catheter or at an angle less than 45 degrees relative to the longitudinal axis of the catheter.

5. The embolic protection device according to any one of claims 1 to 4, wherein the embolic protection device has a handle, and the handle includes a mechanism configured to advance or retract the wire.

6. The embolic protection device according to any one of claims 1 to 5, wherein the embolic protection device has a handle, and the handle includes a mechanism configured to advance or retract the deployment mechanism.

7. The embolic protection device according to any one of claims 1 to 6, wherein the opening of the embolic filter defined by the frame is generally elliptical.

8. The embolic protection device according to any one of claims 1 to 7, wherein the catheter extends through the opening of the embolic filter.

9. The embolic protection device according to any one of claims 1 to 8, wherein the distal portion of the catheter includes a radiopaque marker.

10. The embolic protection device according to claim 9, wherein the radiopaque marker includes one or more circumferential bands.

11. The embolic protection device according to any one of claims 1 to 10, wherein the frame includes a shape memory material.

12. The embolization protection device according to any one of claims 1 to 11, wherein the embolization filter comprises a filter medium, and the filter medium comprises a semi-permeable polyurethane material having a pore size of from about 100 microns to about 150 microns.

13. The embolization protection device according to any one of claims 1 to 12, wherein the embolization protection device comprises longitudinal grooves along an outer surface of the embolization protection device.

14. The embolization protection device according to any one of claims 1 to 13, further comprising a self-expanding deflector proximally coupled to the catheter in the proximal portion of the distal portion, wherein a longitudinal axis of the deflector is parallel to a longitudinal axis of the catheter.

15. The embolization protection device according to any one of claims 1 to 14, wherein the deployment mechanism comprises a sheath circumferentially disposed around at least a portion of the catheter, wherein when the sheath is at least partially longitudinally retracted, the sheath deploys the self-expanding embolization filter.

16. The embolization protection device according to any one of claims 1 to 15, wherein a distal portion of the catheter comprises one or more orifices in communication with the lumen of the catheter.

17. A method of capturing embolic debris during a closed-heart surgery, the method comprising: inserting a distal end of an embolization protection device into a body cavity, the embolization protection device comprising: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along a longitudinal axis of the catheter, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion assuming a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolization filter disposed around the catheter proximally of the distal portion, wherein the embolization filter comprises a frame, and the frame defines an opening of the embolization filter; a deployment mechanism disposed around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism being configured to contain the embolization filter in a folded configuration, and the embolization filter being configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire coupled to the frame of the embolization filter, wherein the wire is longitudinally movable and, when longitudinally retracted, longitudinally bends the frame toward the proximal end of the catheter and laterally outwardly from the catheter such that the opening of the embolization filter generally faces the distal end of the catheter; and tracing the lumen of the catheter over a guide wire percutaneously inserted into the body cavity.

18. The method according to claim 17, further comprising at least partially longitudinally retracting the guide wire from the lumen of the catheter such that the distal portion of the catheter assumes a generally arcuate shape that is at least semi-circular.

19. The method according to claim 17 or 18, wherein the distal portion of the catheter comprises a radiopaque marker; and the method further comprises positioning the catheter by visualizing the radiopaque marker using an imaging technique.

20. The method of any one of claims 17 to 19, further comprising at least partially longitudinally retracting the deployment mechanism and allowing the self-expanding embolic filter to assume an expanded, deployed configuration.

21. The method of any one of claims 17 to 20, further comprising longitudinally retracting the wire, thereby bending the frame longitudinally toward a proximal end of a catheter and laterally outward from the catheter, wherein the opening defined by the frame substantially spans the body cavity.

22. The method of any one of claims 17 to 20, further comprising longitudinally retracting the wire to a proximal position, thereby bending the frame so that an opening of the embolic filter defined by the frame is substantially perpendicular to a longitudinal axis of the catheter, wherein the opening defined by the frame substantially spans a body cavity.

23. The method of any one of claims 17 to 22, wherein the embolic filter is movably coupled to the catheter and is longitudinally movable relative to the catheter; the method further comprising moving the embolic filter longitudinally relative to the catheter.

24. The method of any one of claims 17 to 23, wherein the embolic protection device further comprises a self-expanding deflector coupled to the catheter proximally of the distal portion; and the method further comprises deploying the self-expanding deflector to direct embolic debris toward the embolic filter.

25. The method of any one of claims 17 to 24, wherein the deployment mechanism is a sheath disposed circumferentially around at least a portion of the catheter.

26. The method of any one of claims 17 to 25, wherein the distal portion of the catheter comprises one or more openings communicating with the lumen of the catheter; and the method further comprises infusing a fluid into the body cavity through the one or more openings.

27. The method of any one of claims 17 to 26, wherein the embolic protection device comprises a longitudinal groove along an outer surface of the embolic protection device; and the method further comprises inserting a second catheter device side by side with the embolic protection device by tracking the second catheter device along the groove.

28. The method of claim 27, wherein the second catheter device is advanced through the embolic filter of the embolic protection device when the embolic filter is in the deployed configuration.

29. A method for capturing embolic debris during closed heart surgery, the method include: Inserting a distal end of an embolic protection device into a body cavity, the embolic protection device comprising: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to accommodate a guidewire and a distal portion of the catheter that assumes a generally arcuate shape that is at least semicircular when the guidewire is at least partially longitudinally retracted; a self-expanding embolic filter disposed about the catheter proximally of the distal portion, wherein the embolic filter includes a frame and the frame defines an opening of the embolic filter; An expansion mechanism arranged around at least a portion of the catheter, wherein the expansion mechanism is longitudinally movable relative to the catheter, the expansion mechanism is configured to contain the embolic filter in a folded configuration, and the embolic filter is configured to self-expand when the expansion mechanism is longitudinally retracted; A wire coupled to the frame of the embolic filter, wherein the wire is longitudinally movable and, when longitudinally retracted, bends the frame longitudinally toward the proximal end of the catheter and laterally outwardly from the catheter such that the opening of the embolic filter faces generally distally of the catheter; and Tracking the lumen of the catheter over the wire inserted percutaneously into the body cavity; At least partially longitudinally retracting the guide wire from the lumen of the catheter such that the distal portion of the catheter assumes a generally arcuate shape that is at least semi-circular when the guide wire is retracted from the distal portion of the catheter; Longitudinally retracting the expansion mechanism and deploying the self-expanding embolic filter; and Longitudinally retracting the wire and bending the frame of the embolic filter longitudinally toward the proximal end of the catheter and laterally outwardly from the catheter.

30. A method for capturing embolic debris during a closed-heart procedure, comprising: (i) providing an embolic protection device, wherein the embolic protection device comprises: A catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion assuming a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; A self-expanding embolic filter disposed around the catheter proximal to the distal portion, wherein the embolic filter comprises a frame and the frame defines an opening of the embolic filter; An expansion mechanism arranged around at least a portion of the catheter, wherein the expansion mechanism is longitudinally movable relative to the catheter, the expansion mechanism is configured to contain the embolic filter in a folded configuration, and the embolic filter is configured to self-expand when the expansion mechanism is longitudinally retracted; and A wire coupled to the frame of the embolic filter, wherein the wire is longitudinally movable and is configured to bend the frame longitudinally toward the proximal end of the catheter and laterally outwardly from the catheter when longitudinally retracted such that the opening of the embolic filter faces generally distally of the catheter; and (ii) inserting the distal end of the embolic protection device into the body cavity by tracking the lumen of the catheter over a guide wire inserted percutaneously into the body cavity; and (iii) longitudinally retracting the expansion mechanism and deploying the self-expanding embolic filter.

31. An embolic protection device, comprising: A catheter having a proximal end, a distal end, and a lumen extending along the longitudinal axis of the catheter from the proximal end to the distal end, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion assuming a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; A self-expanding embolic filter disposed around the catheter proximal to the distal portion, wherein the embolic filter comprises a frame and the frame defines an opening of the embolic filter; Deployment mechanism, which is arranged around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism is configured to contain the embolic filter in a folded configuration, and the embolic filter is configured to self-expand when the deployment mechanism is longitudinally retracted; Wire, which is coupled to the frame of the embolic filter, wherein the wire is longitudinally movable relative to the catheter; The wire is configured to, when the wire is longitudinally advanced in the distal direction to a first position, bend the frame longitudinally towards the distal end of the catheter and bend laterally outward from the catheter, such that the opening of the embolic filter faces generally towards the distal end of the catheter and expands to a first diameter; and The wire is configured to, when the wire is longitudinally advanced distally in the distal direction to a second position further than the first position, extend the frame radially outward from the catheter, such that the opening of the embolic filter expands to a second diameter greater than the first diameter.

32. The embolic protection device according to claim 31, wherein the wire is configured to bend the frame when longitudinally advanced to the first position, such that the opening of the embolic filter defined by the frame is generally perpendicular to the longitudinal axis of the catheter.

33. The embolic protection device according to any one of claims 31 or 32, wherein the wire is configured to, when longitudinally retracted to a proximal position, position the frame such that the opening of the embolic filter defined by the frame is generally parallel to the longitudinal axis of the catheter or at an angle less than 45 degrees relative to the longitudinal axis of the catheter.

34. The embolic protection device according to claim 31, wherein the frame includes two side edges; each side edge of the frame extends generally away from the catheter in a first lateral direction, then wraps around on the opposite side edge of the catheter, and extends generally in an opposite lateral direction before converging and meeting to form the opening of the embolic filter, the opening having a generally elliptical, oval or circular shape.

35. The embolic protection device according to claim 31, wherein the frame comprises: A fixed portion, which is coupled to the catheter proximally of the distal portion, wherein the fixed portion does not move in the longitudinal direction; and A movable portion, which is continuous with the fixed portion of the frame, wherein the movable portion is coupled to the wire and is pushed by the wire; When the wire is advanced to the first position, the wire pushes the movable portion of the frame longitudinally towards the distal end of the catheter and bends the frame to expand the opening of the embolic filter to the first diameter; and When the wire is advanced to the second position, the wire pushes the movable portion of the frame radially away from the catheter and extends the frame to expand the opening of the embolic filter to the second diameter.

36. The embolic protection device according to claim 35, further comprising an outer catheter, which is arranged around at least a portion of the catheter and is coaxial with the lumen of the catheter, wherein the outer catheter is longitudinally slidable on the catheter; and wherein the wire is connected to a distal portion of the outer catheter such that the wire moves by sliding through the outer catheter over the catheter.

37. The embolic protection device according to claim 36, further comprising: an inner catheter disposed between the outer catheter and the catheter, wherein the inner catheter is longitudinally slidable over the catheter; and a guide member having one end attached to a distal portion of the inner catheter so that the guide member moves by sliding through the inner catheter over the catheter, wherein the guide member slidably receives a movable portion of the frame such that the guide member bends outwardly away from the catheter.

38. The embolic protection device according to claim 37, wherein the guide member is a top guide member, and the embolic protection device further comprises a bottom guide member having one end attached to the catheter, wherein the bottom guide member and the top guide member are disposed on opposite sides of the catheter, and wherein the bottom guide member receives a fixed portion of the frame such that the bottom guide member bends outwardly away from the catheter.

39. The embolic protection device according to any one of claims 31 to 35, wherein the embolic protection device has a handle, wherein the handle comprises a mechanism configured to advance or retract the wire.

40. The embolic protection device according to claim 37, further comprising: a handle connected to a proximal end of the catheter; a top pull member connected to a proximal portion of the outer catheter and longitudinally movable within the handle; a bottom pull member connected to a proximal portion of the inner catheter and longitudinally movable within the handle, wherein the bottom pull member is in temporary engagement with the top pull member; when the top pull member and the bottom pull member are engaged, the top pull member and the bottom pull member move together by the movement of a slider, which in turn pushes the guide member together with the movable portion of the frame in the longitudinal direction and expands the opening of the embolic filter to a first diameter; and when the top pull member and the bottom pull member are disengaged, the top pull member moves by the movement of the slider without the bottom pull member, which in turn pushes the movable portion of the frame in the radial direction and expands the opening of the embolic filter to a second diameter.

41. The embolic protection device according to any one of claims 31 to 40, wherein the catheter extends through the opening of the embolic filter.

42. The embolic protection device according to any one of claims 31 to 41, wherein a distal portion of the catheter comprises a radiopaque marker.

43. The embolic protection device according to claim 42, wherein the radiopaque marker comprises one or more circumferential bands.

44. The embolic protection device according to any one of claims 31 to 43, wherein the frame comprises a shape memory material.

45. The embolic protection device according to any one of claims 31 to 44, wherein the embolic filter comprises a filter medium, the filter medium comprising a semi-permeable polyurethane material having a pore size of from about 100 microns to about 150 microns.

46. The embolization protection device according to any one of claims 21 to 45, wherein the embolization protection device includes a longitudinal groove along an outer surface of the embolization protection device.

47. The embolization protection device according to any one of claims 31 to 46, wherein the deployment mechanism includes a sheath circumferentially disposed around at least a portion of the catheter, wherein when the sheath is at least partially longitudinally retracted, the sheath deploys the self-expanding embolization filter.

48. The embolization protection device according to any one of claims 31 to 47, wherein a distal portion of the catheter includes one or more orifices in communication with the lumen of the catheter.

49. A method of capturing embolic debris during a closed-heart procedure, the method comprising: inserting a distal end of an embolization protection device into a body cavity, the embolization protection device including: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along a longitudinal axis of the catheter, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion having a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolization filter disposed around the catheter proximal to the distal portion, wherein the embolization filter includes a frame and the frame defines an opening of the embolization filter; a deployment mechanism disposed around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism being configured to contain the embolization filter in a folded configuration, and the embolization filter being configured to self-expand when the deployment mechanism is longitudinally retracted; a wire coupled to the frame of the embolization filter, wherein the wire is longitudinally movable relative to the catheter; the wire being configured to cause the frame to longitudinally bend toward the distal end of the catheter and bend laterally outward from the catheter when the wire is longitudinally advanced distally to a first position, such that the opening of the embolization filter generally faces the distal end of the catheter and expands to a first diameter; and the wire being configured to cause the frame to radially extend outward from the catheter when the wire is longitudinally advanced distally to a second position further than the first position, such that the opening of the embolization filter expands to a second diameter greater than the first diameter; and tracing the lumen of the catheter over a guide wire inserted percutaneously into the body cavity.

50. The method according to claim 49, further comprising at least partially longitudinally retracting the guide wire from the lumen of the catheter so that the distal portion of the catheter presents a generally arcuate shape that is at least semi-circular.

51. The method according to claim 49 or 50, wherein the distal portion of the catheter includes a radiopaque marker; and the method further includes positioning the catheter by visualizing the radiopaque marker using imaging techniques.

52. The method according to any one of claims 49 to 51, further comprising at least partially longitudinally retracting the deployment mechanism and allowing the self-expanding embolization filter to assume an expanded deployed configuration.

53. The method according to any one of claims 49 to 52, further comprising longitudinally advancing the wire to the first position so as to longitudinally bend the frame towards the distal end of the catheter and laterally bend it outwards from the catheter, and expanding the opening of the embolization filter to a first diameter that generally spans the body cavity.

54. The method according to claim 53, further comprising longitudinally advancing the wire distally to a second position further than the first position so as to radially extend the frame outwards from the catheter and expand the opening of the embolization filter to a second diameter greater than the first diameter that generally spans the body cavity.

55. The method according to any one of claims 49 to 52, further comprising longitudinally advancing the wire to the first position so as to bend the frame such that the opening of the embolization filter defined by the frame is generally perpendicular to the longitudinal axis of the catheter, wherein the opening defined by the frame generally spans the body cavity.

56. The method according to any one of claims 49 to 55, wherein the deployment mechanism is a sheath circumferentially arranged around at least a portion of the catheter.

57. The method according to any one of claims 49 to 56, wherein the distal portion of the catheter includes one or more orifices in communication with the inner lumen of the catheter; the method further comprises perfusing fluid into the body cavity through the one or more orifices.

58. The method according to any one of claims 49 to 57, wherein the embolization protection device includes longitudinal grooves along the outer surface of the embolization protection device; and the method further comprises inserting a second catheter device side by side with the embolization protection device by tracing the second catheter device along the grooves.

59. The method according to claim 58, wherein when the embolization filter is in the deployed configuration, advancing the second catheter device through the embolization filter of the embolization protection device.

60. A method for capturing embolic debris during a closed-heart surgery, the method comprising: inserting the distal end of an embolization protection device into the body cavity, the embolization protection device comprising: a catheter having a proximal end, a distal end, and an inner lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the inner lumen is configured to accommodate a guide wire and a distal portion of the catheter, the distal portion presenting a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolization filter arranged around the catheter proximal to the distal portion, wherein the embolization filter includes a frame, and the frame defines an opening of the embolization filter; a deployment mechanism arranged around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism is configured to contain the embolization filter in a folded configuration, and the embolization filter is configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire coupled to the frame of the embolization filter, wherein the wire is longitudinally movable relative to the catheter; tracing the inner lumen of the catheter along a guide wire inserted percutaneously into the body cavity; At least partially longitudinally retract the guide wire from the lumen of the catheter so that the distal portion of the catheter assumes a generally arcuate shape that is at least semi-circular when the guide wire is retracted from the distal portion of the catheter; Longitudinally retract the deployment mechanism and deploy the self-expanding embolic filter; Longitudinally advance the wire in the distal direction to a first position such that the frame bends longitudinally toward the distal end of the catheter and bends laterally outward from the catheter, and expand the opening of the embolic filter to a first diameter.

61. The method of claim 60, further comprising longitudinally advancing the wire in the distal direction to a second position further distal than the first position such that the frame extends radially outward from the catheter and expands the opening of the embolic filter to a second diameter greater than the first diameter.

62. A method for capturing embolic debris during a closed-heart procedure, comprising: (i) providing an embolic protection device, wherein the embolic protection device comprises: a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, wherein the lumen is configured to receive a guide wire and a distal portion of the catheter, the distal portion assuming a generally arcuate shape that is at least semi-circular when the guide wire is at least partially longitudinally retracted; a self-expanding embolic filter disposed proximally of the distal portion about the catheter, wherein the embolic filter comprises a frame, and the frame defines an opening of the embolic filter; a deployment mechanism disposed about at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism is configured to contain the embolic filter in a collapsed configuration, and the embolic filter is configured to self-expand when the deployment mechanism is longitudinally retracted; and a wire coupled to the frame of the embolic filter, wherein the wire is longitudinally movable relative to the catheter; and (ii) inserting the distal end of the embolic protection device into a body cavity by tracking the lumen of the catheter over a guide wire percutaneously inserted into the body cavity; (iii) longitudinally retracting the deployment mechanism and deploying the self-expanding embolic filter; and (iv) longitudinally advancing the wire in the distal direction to a first position such that the frame bends longitudinally toward the distal end of the catheter and bends laterally outward from the catheter, and expand the opening of the embolic filter to a first diameter.

63. The method of claim 62, further comprising longitudinally advancing the wire in the distal direction to a second position further distal than the first position such that the frame extends radially outward from the catheter and expands the opening of the embolic filter to a second diameter greater than the first diameter.

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