Embolic protection device

Abstract

The present invention includes an embolic protection device comprising: a catheter having a self-expanding embolic filter disposed about a distal portion of the catheter, wherein the embolic filter comprises a frame and the frame defines an opening of the embolic filter, the opening facing the distal end of the catheter; 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 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] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] 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 incorporated herein by reference in its entirety. Technical Field

[0003] The present application relates to embolic protection devices including catheters, and methods of using such embolic protection devices in medical procedures, such as closed heart surgery. Background Art

[0004] Conventional pigtail catheters are used in percutaneous cardiac surgery, 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 anatomical structure, 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 a small orifice at their distal end through which contrast media can be injected into the patient's vasculature in order to image relevant portions of the patient's anatomical structure and identify anatomical landmarks.

[0005] However, the use of conventional pigtail catheters in percutaneous cardiac procedures often results in serious, life-threatening complications for the patient. For example, cerebral embolism is a common complication in cardiac procedures (e.g., valve replacement and repair) in which conventional pigtail catheters are deployed. During such surgical procedures, plaque, calcium, emboli, or any combination thereof, in blood vessels, valves, and / or heart chambers may be dislodged by a catheter or other medical device introduced into the patient's vasculature. The dislodged plaque, calcium, emboli, or any combination thereof may be carried via blood flow from the aorta to the patient's brain, where they may cause a blockage leading to an embolic event such as a stroke. Approximately 2.9%-6.7% of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) experience a stroke within 30 days, and even more (4.5%-10.6%) suffer a stroke within a year that often results in death. In addition, up to 85% of patients undergoing TAVI have evidence of cerebral embolic phenomena based on neuroimaging studies. Although clinically silent, this embolic phenomenon has been associated with cognitive decline (Astraci 2011; Ghanem 2010; Kahlert 2010; Rodes-Caban 2011).

[0006] Currently, there are several devices on the market designed to protect the brain, abdominal organs, and carotid arteries from emboli, which are plagued by various significant drawbacks. For example, the Embrella EmbolicDeflector®, manufactured by Edwards Life Sciences, Irvine, California, uses a deflector plate to deflect emboli from the carotid artery to the descending aorta, but the device does not trap the emboli, so the emboli are free to travel to other parts of the body and cause harmful complications. EMBOL-X®, also manufactured by Edwards Life Sciences, uses a filter, but the device is designed for open heart surgery, which poses additional medical risks and increases morbidity. In addition, the use of multiple devices, such as a catheter for visualization and a separate filter device, prolongs the operation time and increases the risk of complications for patients. Summary of the invention

[0007] The present invention addresses these and other needs by providing an embolic protection device that includes an expandable embolic filter disposed about a catheter having a distal portion that can assume an arcuate configuration that is at least semicircular and having a wire operable to manipulate the embolic filter into a configuration that more fully engages a body lumen.

[0008] The combination of a catheter and an embolic filter in the same device can provide the benefits of both devices separately and provide a synergistic effect. For example, the integration of a catheter and an embolic filter can reduce the duration of medical procedures and reduce the occurrence of complications (such as complications 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 susceptible to blood flow, tissue movement, etc. In valve replacement surgery, anchoring of the catheter and more precise positioning of the catheter can help ensure that the valve prosthesis is properly positioned and stabilized. In another example, the position of the catheter can ensure that the filter is properly positioned.

[0009] In some aspects, the embolic protection device includes a catheter, a self-expanding embolic filter coupled to the catheter, a pull wire for redirecting 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 folded configuration when it surrounds the embolic filter and retracts proximally to unfold the embolic filter. The outer sheath can recapture the embolic filter and any debris captured therein by being advanced distally. Both the filter and the outer sheath can be moved relative to the catheter, for example so that the embolic filter can be moved longitudinally without having to move the entire catheter longitudinally. The advantage of the pull wire is its ability to bend the frame, thereby causing the filter opening to be toward the distal end of the device and allowing the embolic filter to more fully engage the body cavity.

[0010] In some aspects, the catheter has a proximal end and a distal end. The 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.

[0011] In some 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 of at least a semicircle. The pigtail catheter can have a radiopaque marker visible on an X-ray or other medical imaging device. The radiopaque marker is in the form of a longitudinal marker, a circumferential band, etc. on the distal portion of the curled pigtail catheter. The pigtail catheter can additionally have one or more orifices to distribute drugs and / or contrast agents through the lumen.

[0012] In some aspects, a guide wire is inserted through the patient's skin and inserted into a body cavity such as, for example, a femoral artery, a radial artery, or a brachial artery, and manipulated near a target site. The guide wire is inserted into the lumen of the embolic protection device, and the embolic protection device is pushed or tracked on the guide wire to the target site. When the guide wire is retracted from at least the distal portion of the catheter, the catheter presents a generally arcuate shape. Radiopaque markers on the catheter are used to visualize and locate 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 over the entire blood vessel. The user can then perform operations such as valve replacement, valve repair, radiofrequency ablation, and the like. After the operation 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 blood vessel, and the catheter is non-damaging to the blood vessel during retraction.

[0013] Another aspect is a method for capturing embolic debris during closed heart surgery, the method comprising inserting a distal end of a catheter of an embolic protection device into a body cavity. The method further comprises allowing the embolic filter to assume an expanded deployed configuration and retracting a pull wire to bend the filter frame so that a distal opening of the filter spans the body cavity.

[0014] In some aspects, an embolic protection device comprises: a catheter; a self-expanding embolic filter coupled to the catheter; a push wire for redirecting 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 surrounds the embolic filter, the outer sheath holds the embolic filter in a folded configuration and is retracted proximally to deploy the embolic filter. The outer sheath can recapture the embolic filter and any debris captured therein by being pushed distally. The advantage of the push wire is its ability to bend and extend the frame, thereby directing the filter opening toward the distal end of the device and allowing the embolic filter to more fully engage the body cavity.

[0015] In some aspects, the catheter has a proximal end and a distal end. The 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.

[0016] In some 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 of at least a semicircle. The pigtail catheter can have a radiopaque marker visible on an X-ray or other medical imaging device. The radiopaque marker is in the form of a longitudinal marker, a circumferential band, etc. on the distal portion of the curled pigtail catheter. The pigtail catheter can additionally have one or more orifices to distribute drugs and / or contrast agents through the lumen.

[0017] In some aspects, a guide wire is inserted through the patient's skin into a body cavity such as a femoral artery, a radial artery, or a brachial artery and manipulated near a target site. The guide wire is inserted into the lumen of the embolic protection device, and the embolic protection device is pushed or tracked on the guide wire to the target site. When the guide wire is retracted from at least the distal portion of the catheter, the catheter presents a generally arcuate shape. Radiopaque markers on the catheter are used to visualize and position the catheter. Once the catheter is in place, the outer sheath is retracted to deploy the embolic filter, and the push wire is advanced to bend and extend the filter frame to position the distal opening of the embolic filter over the entire blood vessel. The user can then perform operations such as valve replacement, valve repair, radiofrequency ablation, etc. After the operation is completed, the push wire is retracted 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 blood vessel, and the catheter does not damage the blood vessel during retraction.

[0018] Another aspect is a method for capturing embolic debris during closed heart surgery, the method comprising inserting a distal end of a catheter of an embolic protection device into a body cavity. The method further comprises allowing the embolic filter to assume an expanded deployed configuration and advancing a push wire to bend and extend the filter frame so that a distal opening of the filter spans the body cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The following drawings are provided by way of example and are not intended to limit the scope of the claimed invention.

[0020] Figure 1A and 1B A partial side view of an embodiment of the embolic protection device of the present invention is shown. Figure 1A In FIG, an embolic filter of an embolic protection device is shown in a folded (undeployed) configuration. Figure 1B , the embolic filter is shown in an expanded (deployed) configuration, wherein a pull wire secured to the embolic filter frame is advanced to a distal position to cause the frame to assume its self-expanding and undeflected (ie, unbent) configuration.

[0021] Figure 1C A side perspective view of an embodiment of an embolic filter of the present invention is shown assuming a partially deflected (ie, partially bent) configuration in which a pull wire secured to the embolic filter frame is partially longitudinally retracted to a proximal position.

[0022] Figure 1D A cross-sectional view of an embodiment of an embolic filter of the present invention is shown assuming a fully deflected (eg, fully bent) configuration in which the pull wire is fully longitudinally retracted, thereby deflecting the filter.

[0023] Figure 1E and 1F A 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.

[0024] FIG. 2A to FIG. 2B A partial side view of an embodiment of the embolic protection device of the present invention including a shoulder is shown.

[0025] FIG. 3A to FIG. 3D A partial side view of an embodiment of the embolic protection device of the present invention including an intermediate tube is shown.

[0026] FIG. 4A to FIG. 4C A partial side view of an embodiment of the embolic protection device of the present invention including a deflector is shown.

[0027] 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.

[0028] Fig. 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.

[0029] 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.

[0030] Fig.6D and Fig. 6EShown 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.

[0031] Fig. 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.

[0032] 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.

[0033] Fig. 8A and 8B An embodiment of the embolic protection device according to the invention is shown, which has a handle for manually operating the embolic filter.

[0034] Figures 8C-8F An example of a handle is shown.

[0035] Figures 9A-9E A step-by-step method of using the embolic protection device of the present invention is shown.

[0036] Fig.10 Deflection and capture of embolic debris by an embolic protection device of the present invention including a deflector is shown.

[0037] Fig.11 Deflection and capture of embolic debris by the embolic protection device of the present invention is shown, wherein a second catheter device is present.

[0038] FIG. 12A to FIG. 12D A step-by-step method of operating an embolic protection device using an embolic filter of the present invention is shown.

[0039] Fig.13A and 13B is a photograph of the distal portion of the embolic protection device of the present invention located within a cadaver vessel according to Example 1. Fig.13A In the embodiment, the embolic protection device comprises a longitudinal groove, and the second catheter is inserted into the groove side by side with the embolic protection device. Fig. 13B In the embodiment, the second catheter is located adjacent to the embolic protection device lacking the longitudinal groove.

[0040] Fig.14 is a bar graph of performance data for an embolic protection device of the present invention according to Example 2 (EPD-1 device).

[0041] FIG. 15A to FIG. 15J is an image generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative subject according to Example 2.

[0042] Fig.16A is a photograph of an embolus captured by the embolic protection device of the present invention according to Example 2 (EPD-1 device).

[0043] Fig. 16B is a photograph of collagen fragments trapped within the filter of an embolic protection device according to Example 2 (EPD-1 device).

[0044] In the various drawings, the same reference numerals denote the same components. DETAILED DESCRIPTION

[0045] The present invention provides an embolic protection device and a method for capturing embolic debris using the embolic protection device during surgical procedures.

[0046] I. Definition

[0047] As used herein, the term "self-expanding" means growing, unwinding, or unfolding from a folded state when a restraining or constraining force is retracted or removed.

[0048] As used in this application, the term "closed heart" refers to any surgical procedure involving the heart in which the chest cavity is not opened.

[0049] As used herein, the term "braid" refers to any material comprising a plurality of strands, wherein the strands are interwoven to form a net, mesh, or screen. Without limitation, examples of braided materials include a net or mesh comprising a polymer, a metal, or a metal alloy.

[0050] As used in this application, the term "nonwoven" refers to any material including a continuous film. The nonwoven material can be permeable, semi-permeable or impermeable. For example, a permeable or semi-permeable nonwoven material can optionally include one or more orifices through which a fluid can pass.

[0051] As used herein, the term "alloy" refers to a homogeneous mixture or solid solution produced by combining two or more metallic elements, for example to provide greater strength or corrosion resistance. For example, alloys include brass, bronze, steel, nickel titanium alloy, chrome cobalt, MP35N, 35NLT, Elgiloy, etc.

[0052] As used herein, "nitinol" and "nickel titanium" are used interchangeably to refer to an alloy of nickel and titanium.

[0053] As used in this application, "chrome cobalt" refers to an alloy of chromium and cobalt.

[0054] As used herein, "MP35N" refers to an alloy of nickel and cobalt.

[0055] As used herein, "35NLT" refers to a cobalt-based alloy that may also include chromium, nickel, molybdenum, carbon, manganese, silicon, phosphorus, sulfur, titanium, iron, and boron.

[0056] As used in this application, "Elgiloy non-magnetic alloy" refers to an alloy of cobalt, chromium, nickel, iron, molybdenum, and manganese.

[0057] As used herein, "body cavity" refers to the interior space of a tubular structure in the human body, such as arteries, intestines, veins, gastrointestinal tract, bronchi, renal tubules, and urinary tract. In some cases, the body cavity refers to the aorta.

[0058] 2. Embolic protection device

[0059] Although certain embodiments and examples are described below, those skilled in the art will recognize that the present disclosure transcends the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Therefore, the scope of the disclosure presented in this application should not be limited to any specific embodiments described below.

[0060] For the purposes of this disclosure, the terms "upper", "lower", "right", "left", "rear", "front", "vertical", "horizontal" and their derivatives shall be used as in Figure 1B and 1F in (or in Figure 6B and 6C The invention is not limited to the following aspects. However, it should be understood that the invention may assume various alternative orientations unless expressly indicated to the contrary. Likewise, for purposes of this disclosure, the term "coupled" (in all its forms, coupled to, coupled to, coupled, etc.) generally refers to the joining of two components (electrical or mechanical) directly or indirectly to one another. Such joining may be fixed or movable in nature; may be achieved by the two components (electrical or mechanical) and any other intermediate members being integrally formed as a single entity with one another or with the two components; and may be permanent in nature, or removable or releasable in nature, unless otherwise specified.

[0061] Figure 1A and 1B Embodiments of embolic protection device 100 are shown. In these embodiments, device 100 includes catheter 102 (e.g., a pigtail catheter) having a proximal end 114, a distal end 116, and a lumen 118 extending from proximal end 114 to distal end 116. Lumen 118 can be configured to receive guide wire 990 (see Fig. 9A and 9B), the guide wire 990 can be moved longitudinally through the lumen to coil or straighten the distal portion 104 of the catheter 102 depending on whether the guide wire is retracted (to coil 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 semicircular. The sidewall of the catheter 102 can optionally include one or more orifices 108 in the distal portion 104, which are configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, etc.) to the body cavity 992 (see Fig. 9A ). A plurality of orifices 108 ("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 wrapped around the distal portion of the catheter and may have the same or different widths. In other embodiments, the radiopaque markers are co-linear with the lumen and extend to the distal end of the catheter. The device 100 also includes a self-expanding embolic filter 110 defined by a frame 124 and a filter media 126, and a deployment mechanism 112 (e.g., a longitudinally retractable outer sheath or a longitudinally retractable ring). The embolic filter 110 is arranged around the catheter 102.

[0062] like Figure 1B As shown, the embolic filter 110 includes, in its deployed configuration, a distal opening 140 defined by a 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.

[0063] In some embodiments, retracting the pullwire 122 may cause the distal opening 140 of the embolic filter 110 to engage the intracorporeal body lumen 992 (see Fig.9D ) at least a portion of a wall. Figure 1B The puller wire 122 is shown in an advanced configuration (i.e., an unretracted or self-expanded configuration) wherein the frame is generally oriented to extend in the distal longitudinal direction, although slightly tilted posteriorly in the lateral direction (e.g., less than about 45 degrees). The catheter 102 can be partially surrounded toward its proximal end 114 by a support catheter 150 that terminates in a head 152 proximate to the distal portion 104 of the catheter 102. The support catheter 150 can be made of a thick, hard material to increase rigidity and provide a protective layer or support layer around the catheter 102.

[0064] Figure 1CAn embolic filter 110 is shown deployed (e.g., self-expanding) by retraction of a deployment mechanism (e.g., an outer sheath) 112, wherein 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 coupling 134. A distal opening 140 is primarily defined by a first portion 132 of the frame 124. The first portion 132 of the frame 124 defines a shape of the distal opening 140 that is substantially elliptical (i.e., shaped like an ellipse), or substantially rugby-shaped or circular. In this embodiment, the portion 132 of the frame 124 may be generally elliptical and may terminate at a V-shaped point at its proximal end, i.e., the portion 132 of the frame 124 may reverse its bend at one end of its generally elliptical shape (e.g., at its distal end) and taper at its proximal end. The distal opening 140 may be substantially defined by the frame 124, but may span the frame 124, adjacent to the tapered portion of the frame 124. The filter media 126 may define a portion of the distal opening 140 , wherein the filter media 126 spans the frame 124 , ie, adjacent to the attachment point of the frame 124 to the catheter 102 or support catheter 150 .

[0065] The attachment of the frame 124 to the support catheter 150 (or directly to the catheter 102) is achieved via the second portion 130 of the frame 124, which 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 can be fixed in position by friction and tension in the lateral and / or longitudinal directions of the embolic filter 110. In other embodiments, the fixed attachment of the second portion 130 of the frame 124 to the support catheter 150 (or catheter 102) can also be achieved via adhesives, welding, etc.

[0066] The first portion 132 of the frame 124 can extend away from the conduit 102 in a first transverse direction and away from the second portion 130 of the conduit 102, and wrap around across the conduit 102 and extend in an opposite transverse direction. In this embodiment, the first portion 132 of the frame 124 includes two sides (132a, 132b), each of which extends away from the conduit 102 generally in the first transverse direction, and then wraps around the opposite side of the conduit 102 and extends generally in opposite transverse directions before converging and merging to form a generally elliptical shape. Figure 1F As shown, the embolic filter 110 is symmetrical 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 of the left side of the embolic filter 110 are mirror images of the components of the right side of the embolic filter 110.

[0067] When the puller wire 122 is in its advanced state (or partially but not fully retracted state), the frame 124 extends in the distal longitudinal direction as it extends from its point of attachment to the catheter 102 (or support catheter 150). When the puller wire 122 is in its retracted state (i.e., fully retracted) (see Figure 1D and Fig.9E ), the frame 124 extends in a distal longitudinal direction near its attachment point to the catheter 102, but then bends so that it extends generally perpendicular to the longitudinal axis of the catheter 102.

[0068] Figure 1D 1 shows a cross-sectional view of the distal opening 140 of the embolic filter 110 when the embolic filter 110 assumes an expanded configuration and when the pull wire 122 is in a fully retracted state, thereby fully deflecting (or bending) the frame 124. The pull wire 122 deflects or bends the frame 124 laterally outward in the 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 be approximately perpendicular to the longitudinal axis of the catheter 102 and can laterally span the body cavity 992 approximately perpendicular to the longitudinal axis of the body cavity 992 (see FIG. Fig.9D and 9E ). The fully deflected (or bent) configuration can allow the embolic filter 110 to more fully engage the body lumen 992. In this fully deflected configuration, the distal opening 140 is substantially perpendicular to the longitudinal axis of the catheter 102. In the fully deflected configuration, the width x of the distal opening 140 may be increased compared to the corresponding dimension in the undeflected configuration. Similarly, in the fully deflected configuration, the length y of the distal opening 140 may be reduced compared to the corresponding dimension in the undeflected configuration. By increasing the width x in the bent configuration, the frame 124 defining the distal opening 140 can more fully engage the body lumen 992.

[0069] In each Figures 1A-1D In the embodiment shown in FIG. 1 , 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 curves around the catheter 102 in an opposite direction.

[0070] The embolic protection device 100 may be non-deflected ( Figure 1B ), partial deflection ( Figure 1C ) or fully deflected ( Figure 1D) configurations. These configurations are achieved by engaging the pull wire 122 in a fully advanced, partially retracted (or partially advanced) or fully retracted state. In the fully advanced state, the pull wire 122 is in a distal position. In the fully retracted state, the pull wire 122 is in a proximal position. When longitudinally retracted to the proximal position, the pull wire 122 is configured to deflect (or bend) the frame 124 so that the distal opening 140 of the filter 110 is approximately 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 so that the distal opening 140 of the filter 110 defined by the frame 124 is approximately parallel to or at an angle of less than about 45 degrees relative to the longitudinal direction of the catheter 102.

[0071] In some embodiments, the distal opening 140 of the embolic filter 110 has a diameter of about 2 cm to about 6 cm (e.g., a diameter of 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's body cavity 992 (see Fig. 9C ). In some embodiments, the embolic filter 110 is coupled to the catheter 102 at the proximal end and / or the distal end of the embolic filter 110 and / or at any other point therebetween. For example, the embolic filter 110 can be coupled to the catheter 102 via the frame 124, particularly the second portion 130 of the frame 124 (the distal attachment point), and can also be coupled to the catheter 102 via the filter media 126 at an attachment point within the sheath 112.

[0072] Figure 1E and 1F The frame 124 of the embolic filter 110 is shown. Figure 1E In the illustrated embodiment, the frame 124 is folded within the outer sheath 112, i.e., the sheath 112 is advanced over the frame 124. 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 coupling 134. The pull wire 122 can be coupled to the frame 124 at the distal coupling 134 by a variety of methods, including by means of a hole in the frame 124 through which the pull wire 122 can be passed and crimped to hold it in place. The distal coupling 134 can also include a change in the curvature of the frame 124, i.e., by reversing the curvature of the frame 124 and becoming pointed. This curvature, along with the curvature of the frame 124 adjacent to the attachment point of the frame 124 to the catheter 102, can help fold the frame 124 so as to advance the sheath 112 over the embolic filter 110. In some embodiments, the frame 124 includes a shape memory material (e.g., a metal alloy or polymer). Examples of shape memory materials include, but are not limited to, nickel titanium alloys, chrome cobalt, and / or other metal alloys, such as MP35N, 35NLT, elgiloy, and the like. In some embodiments, the frame 124 is laser cut from a tube or sheet.

[0073] Figure 2A and Figure 2B An embodiment of an alternative deployment mechanism for an embolic protection device 200 is shown, which includes 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 protruding inwardly from the distal end of the outer sheath 212. The catheter 202 can include one or more shoulders 262 (e.g., a distal shoulder 262a and a proximal shoulder 262b) protruding outwardly from the outer wall of the catheter 202. The lip 260 of the outer sheath 212 is configured to engage the one or more shoulders 262 of the catheter 202 to inhibit or prevent excessive movement of the outer sheath 212 in the proximal direction or the distal direction. The lip 260 and the shoulder 262 can be arcuate, forked, combinations thereof, and the like.

[0074] 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 a lip 260, a shoulder 262, and stops and nubs (e.g., to excessively 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 (e.g., 1 / 2 retracted, 1 / 4 retracted, etc.).

[0075] Benefits of the outer sheath 212 deployment mechanism may include its simplicity, ease of operation, and few moving parts. The embolic protection device 200 is well suited for use in conjunction with delicate cardiac surgeries that carry significant risks. As the duration of the surgery increases, the risk of complications generally increases. Therefore, it is advantageous to enable a user to quickly and easily deploy and recapture the embolic filter 210. More complex devices may be more difficult to operate and more likely to malfunction or cause adverse effects. The ability to move the outer sheath 212 relative to the embolic filter 210 can be advantageous in allowing the user to partially recapture the embolic 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 Fig.9D ), and maneuvering a second catheter or instrument around and through the catheter 202 and the embolic filter 210 as described herein. In some embodiments, an embolic protection device as described herein 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., outer sheath) 112). In such embodiments, a second catheter or instrument may be inserted while engaging the grooves to guide the second device side-by-side with the embolic protection device.

[0076] FIG. 3A to FIG. 3D An embodiment of an embolic protection device 300 is shown in which an embolic 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 embolic 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 move simultaneously and independently. The longitudinal position of the embolic filter 310 relative to the catheter 302 can be adjusted while the embolic filter 310 is in a folded configuration or in an expanded configuration that is deployed or partially deployed. In some embodiments, the periphery of the distal opening of the embolic filter 310 includes one or more radiopaque markers to allow a user to visualize the position of the distal opening, for example, relative to various anatomical landmarks. For example, if the user is performing surgery on a patient's aortic valve and wants to prevent emboli from entering the cerebral arteries, radiopaque markers may be used to ensure that the distal opening of the embolic filter 310 is located in the ascending aorta upstream of the carotid arteries.

[0077] Figure 3A The embolic filter 310 is shown in position (a) constrained in a closed configuration by the outer sheath 312 and the distal end of the intermediate tube 330. If the intermediate tube 330 remains stationary at position (a), the outer sheath 312 can be retracted to Figure 3CIf, instead, the intermediate tube 330 and the outer sheath 312 are moved simultaneously, the embolic filter 310 remains restrained by the outer sheath 312 while the longitudinal position of the embolic filter 310 is adjusted. Figure 3B The embolic filter 310 is shown still being restrained by the outer sheath 312 while the intermediate tube 330 has been retracted so 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 may be retracted to Figure 3D The intermediate tube 330 and the outer sheath 312 can be moved to adjust the longitudinal position of the embolic filter 310 in the expanded or partially expanded configuration. For example, the intermediate tube 330 and the outer sheath 312 can be moved simultaneously to adjust the longitudinal position of the intermediate tube 330 from the expanded or partially expanded configuration to the outer sheath 312. Figure 3C Retract to the position shown Figure 3D Position shown (b).

[0078] In addition to those described in detail in the present application, a variety of deployment mechanisms for embolic filters are also feasible. For example, the deployment system may include a portion of an annular sheath that includes an inward end protrusion that is guided along the catheter body in a track. Certain such embodiments may be beneficial in reducing the profile of the catheter. For another example, the deployment system may include a threaded sheath that moves longitudinally when the user twists it. For another example, the deployment system may include multiple annular bands that can capture the embolic filter longitudinally and / or circumferentially. Combinations of the deployment systems described in the present application and other deployment systems are also feasible.

[0079] FIG. 4A to FIG. 4C Another embodiment of an embolic protection device 400 is shown, which includes a catheter 402, a deflector 460, an embolic filter 410, and a removable outer sheath 412. In some embodiments, the embolic protection device 400 is similar to the embolic protection device 100, but with the addition of a deflector 460.

[0080] Various types and designs of deflectors can be used with embolic protection devices such as the embolic 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 connected to the catheter. For example, the deflectors can be made in various sizes, for example to accommodate differences in patient anatomy. In some embodiments, the deflector comprises a shape memory material, for example, including nickel titanium alloy, chromium cobalt and / or alloys such as MP35N, 35NLT, elgiloy. In some embodiments, the deflector comprises a porous membrane, such as a semipermeable polyurethane membrane / material, which is mounted to a self-expanding frame, for example, a frame comprising a shape memory material.

[0081] picture Figures 4A-4C The example of the deflector 460 shown has a generally butterfly or elliptical shape with two wings or petals 460a and 460b extending to either side of a central axis 464. The wings or petals 460a and 460b may be the same or may be different in shape, material, etc. The deflector 460 is coupled to one side of the catheter 402 via an elongated member 462, which has one end 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 coupled to the catheter 402. In some embodiments, the elongated member 462 comprises a shape memory material, such as, for example, nickel titanium alloy, chromium cobalt, and / or an alloy such as MP35N, 35NLT, elgiloy, which is configured (e.g., shape set) to bias the deflector away from the catheter 402. The deflector 460 is configured to release to a position such as when not constrained by the outer sheath 412. Figure 4B and Figure 4C In some embodiments, the deflector 460 is configured to fold away from the elongated member 462 along the central axis 464 so that the side wings or petals 460a and 460b converge together, and the deflector 460 can be accommodated in, for example, Figure 4A The outer sheath 412 is shown. Figure 4A As shown, the deflector 460 can be initially folded and contained in the outer sheath 412 so that the side wings or petals 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 so that the side wings or petals 460a and 460b are positioned proximal to the central axis 464.

[0082] In some embodiments, the catheter 402 is Figure 4A and Figure 4B The pigtail catheter shown in and described in this application. The catheter 402 includes a distal portion 404 that is configured to present a generally arcuate shape that is at least semicircular. In some embodiments, the distal portion 404 of the catheter 402 includes one or more radiopaque markers 406. The sidewall of the catheter 402 may optionally include one or more orifices 408 in the distal portion 404 that 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.

[0083] The catheter 402 has a proximal end 414 and a distal end 416. Figure 4BAs shown, the example of the catheter 402 is partially surrounded toward its proximal end 414 by a support catheter 450 that terminates in a head 452 that is adjacent to the distal portion 404 of the catheter 402. The support catheter 450 can be made of a thick, strong material to increase rigidity and provide a protective layer or support layer around the catheter 402.

[0084] like Figure 4B As shown, the embolic filter 410 includes a frame 424 and a filter medium 426. In its deployed configuration, the embolic filter 410 includes a distal opening 440 defined by the frame 424, facing the distal end 416 of the catheter 402, and extending proximally from the distal opening 440 to a closed proximal end 442. The device 400 also includes a pull wire 422, which is similar to the above referenced Figure 1B-1D The distal opening 440 is coupled to the frame 424 in a manner similar to that described and may be retracted to deflect or bend the frame 424 and change the orientation and shape of the distal opening 440 .

[0085] In some embodiments, the deflector 460 and the embolic filter 410 can be coupled to another type of catheter, for example, a catheter that does not have a distal portion configured to present an arcuate shape. The embolic filter 410 can be similar to Figures 1A-1D , 2A and 2B and described in this application. In some embodiments, the embolic filter 410 is, for example, Figure 4A-4B 460 is coupled to the catheter 402 proximally of the deflector 460 as shown. In some embodiments, the embolic filter 410 is coupled to the catheter 402 distally of the deflector 460. The embolic filter 410 is coupled such that it is disposed around the catheter 402. This configuration advantageously allows the embolic filter 410 to engage the body cavity 992 (see Fig.9D ) wall, because the catheter 402 is in the body cavity 992 (see Fig.9D ) may be affected by the deployed deflector 460.

[0086] The combination of the deflector 460 and the embolic filter 410 can be advantageous in providing additional protection against potential complications caused by emboli in the blood flow. For example, if the embolic filter 410 (e.g., the distal end of the embolic filter 410) is distal to the deflector 460, the embolic filter 410 can be used as a primary embolic protection device, while the deflector 460 can be used as a secondary embolic protection device. If some blood is able to flow around the embolic filter 410 rather than through it, the deflector 460 acts as a secondary (or backup) protection device and prevents any debris not captured by the embolic filter 410 from entering the cerebral artery and traveling to the brain. If the embolic filter 410 is proximal to the deflector 460, the deflector 460 can be used as a primary embolic protection device, while the embolic filter 410 can be used as a secondary embolic protection device. The deflector 460 first deflects the debris away from the carotid artery, and then the embolic filter 410 captures the debris (e.g., including the deflected debris) as blood flows through the descending aorta.

[0087] In some embodiments, the catheter 402 and outer sheath 412 may have lips, shoulders, nubs, and / or stops, such as those described above. Figure 2A and 2B and those described in this application. For example, a lip, shoulder, nub and / or stop 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 a corresponding lip, shoulder, nub and / or stop on the outer sheath 412. The lip, shoulder, nub and / or stop can be useful in providing information to the user about the longitudinal position of the outer sheath 412 so 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 deployed via a cam similar to Figures 3A-3D An intermediate tube of the type shown and described in this application is movably coupled to conduit 402 .

[0088] Similar to Figures 1A-1E One embodiment of the embolic protection device 100 and the embolic protection device 500 is shown in Figure 5A and 5B The embolic protection device 500 includes a catheter 502, an embolic filter 510, a removable outer sheath 512, and a handle 570. In some embodiments, the catheter 502 is Figure 5B502 and described in this application. The catheter 502 includes a distal portion 504 that is configured to present a generally arcuate shape that is at least semicircular. 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 orifices 508 in the distal portion 504 that 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.

[0089] like Figure 5B As shown, the embolic filter 510 includes a frame 524 and a filter medium 526. In its expanded configuration, the embolic filter 510 is opened toward the distal end 516 of the catheter 502. The device 500 also includes a pull wire 522, which is similar to the pull wire 522 described above. Figures 1B to 1D The filter 510 is coupled to the frame 524 in a manner similar to that described above, and can be retracted to deflect or bend the frame 524 and change the orientation and shape of the embolic filter 510 .

[0090] return Figure 5A The handle 570 has a wire engagement mechanism 574 configured to advance or retract the pull wire 522 by movement of the first slider 572. The handle 570 also has a sheath engagement mechanism 578 configured to advance or retract the deployment mechanism (e.g., outer sheath) 512 by movement of the second slider 576.

[0091] Figures 6A-6G 200. In these embodiments, the embolic protection device 600 includes a catheter 602 (e.g., 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 can be configured to receive a guide wire 1290 (see Fig. 12A ), which can be moved longitudinally through the lumen to coil or straighten the distal portion 604 of the catheter depending on whether the guidewire is retracted (to coil the distal portion) or extended (to straighten the distal portion). In some embodiments, the catheter 602 includes a distal portion 604 that is configured to present a generally arcuate shape that is at least semicircular. The sidewall of the catheter 602 may optionally include one or more orifices 608 in the distal portion 604, which are configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, etc.) to the body cavity 1292 (see Fig. 12A). A plurality of orifices 608 ("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 wrapped around the distal portion 604 of the catheter 602 and can have the same or different widths. The embolic protection device 600 also includes a self-expanding embolic filter 610 defined by a frame 624 and a filter media 626, and a deployment mechanism 612 (e.g., a longitudinally retractable outer sheath or a longitudinally retractable ring). The embolic filter 610 is arranged around the catheter 602.

[0092] Figure 6B The embolic filter 610 is shown deployed in a self-expanding configuration by retraction of a deployment mechanism (e.g., an outer sheath) 612. The embolic filter 610 includes a distal opening 640 defined by a 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 embolic protection device 600 also includes a push wire 622 coupled to the frame 624. The push wire 622 can be advanced in a distal direction to deflect (or bend) and extend the frame 624 and sequentially change the configuration of the embolic filter 610 between self-expansion, partial expansion, and full expansion. In some embodiments, advancing the push wire 622 may cause the distal opening 640 of the embolic filter 610 to change orientation, shape, and / or size to engage the body cavity 1292 (see Fig.12D ) at least a portion of a wall. Figure 6B The push wire 622 is shown in a retracted (i.e., unadvanced) state, with the frame 624 extending in the distal longitudinal direction, although tilted back in the transverse direction at some angle (e.g., less than about 45 degrees) toward the proximal end 614. The catheter 602 may be partially surrounded toward its proximal end 614 by a support catheter 650 that terminates in a head 652 adjacent to the distal portion 604 of the catheter 602. The support catheter 650 may be made of a thick, hard material to increase rigidity and provide a protective layer or support layer around the catheter 602.

[0093] Figure 6C , 6E6G show front end views of the embolic filter 610 viewed from the distal opening 640 in the distal self-expanded, partially expanded, and fully expanded configurations, respectively. For clarity, the catheter 602 is removed from these views. The frame 624 includes two sides (624a, 624b), each of which extends away from the catheter 602 / support catheter 650 in a first lateral direction, then wraps around the catheter 602 / support catheter 650 on opposite sides and extends in opposite lateral directions before converging and merging to form a generally elliptical shape (i.e., an ellipse-like shape) or, alternatively, a generally oval shape (i.e., a rugby-like shape) or a circle. As shown, the embolic filter 610 is symmetrical about a plane (identified in the figure as a dashed line marked "P"). For ease of discussion, the embolic filter 610 is referred to as having a left side and a right side. The components of the left side of the embolic filter 610 are mirror-symmetrical to the components of the right side of the embolic filter 610.

[0094] Fig.6D and 6E The embolic filter 610 is shown in a partially expanded configuration, wherein the frame 624 is deflected (i.e., bent) by advancement of the push 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. The movable portion 630 can move longitudinally relative to the catheter 602 / support catheter 650, while the fixed portion 632 cannot. The frame 624 is coupled to the push wire 622 at the movable portion 630. In a convenient embodiment, the push wire 622 and the movable portion 630 are joined by crimping. In other embodiments, the push 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 to the catheter 602) via 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.

[0095] From the fixed portion 632, the frame 624 extends in the distal longitudinal direction and then bends at an angle relative to the longitudinal axis of the catheter 602 / support catheter 650. When the push wire 622 is in its retracted state, the frame 624 bends at an acute angle and extends in the proximal longitudinal direction so that the frame 624 folds onto itself (see Figure 6B ). Advantageously, in this configuration, the embolic filter 610 can more effectively retain embolic debris captured during surgery. The curved portion of the frame 624 adjacent the movable portion 630 can help to fold the frame 624 so as to advance the outer sheath 612 over the embolic filter 610.

[0096] Fig. 6E622 is advanced and the embolic filter 610 assumes a partially expanded configuration, the front end view of the embolic filter 610 observed from the distal opening 640. The advanced push wire 622 forces the movable portion 630 forward (in Fig.6D 650). This in turn causes the frame 624 to deflect or bend longitudinally and laterally outward in the distal direction. In the deflected configuration (i.e., when the push wire 622 is advanced), the distal opening 640 of the embolic filter 610 can be approximately perpendicular to the longitudinal axis of the catheter 602 / support catheter 650 and can span the body cavity 1292 laterally approximately perpendicular to the longitudinal axis of the body cavity 1292 (see FIG. Fig.12D ). In the deflected configuration, the width X of the distal opening 640 is greater than the corresponding dimension in the non-deflected configuration. bent Increased. By increasing the width X in the curved configuration bent , the frame 624 defining the distal opening 640 engages the body cavity 1292 .

[0097] Fig. 6F and Figure 6G The embolic filter 610 is shown in a fully expanded configuration, wherein the frame 624 is extended by further advancement of the push wire 622 in the distal direction. Further distal movement of the push wire 622 pushes the movable portion 630 laterally relative to the catheter 602 / support catheter 650. This in turn causes the frame 624 to extend radially outwardly away from the catheter 602 / support catheter 650 (at Figure 6G 650). In some embodiments, in addition to extending the frame 624 in the radial direction, the advancing push 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 is formed with a bend or curved portion to help extend the frame 624 in the radial direction.

[0098] In the extended configuration, the width X across the distal opening 640 is extended The corresponding dimensions (X bent ) is larger than that of the previous example. By increasing the width X in the extended configuration extended , so that the frame 624 defining the distal opening 640 engages the body cavity 1292. The width of the distal opening 640 is greater in the partially expanded configuration (X bent ) and the fully extended configuration (X extended) (and intermediate configurations therebetween) can represent a range of filter sizes or diameters, for example, 25 millimeters (mm) to 40 mm. This range of filter sizes accommodates variations in a patient's vasculature. Advantageously, certain embodiments of the embolic protection device 600 provide a single device that can be customized for a specific patient and / or a specific surgical procedure, instead of a one-size-fits-all device or different-size-fits-all devices. For example, a surgeon can expand the embolic filter 610 to a first size and then adjust the embolic filter 610 to a second size to better fit within the patient's vasculature.

[0099] In some embodiments, the diameter of the distal opening 640 of the embolic filter 610 is about 2 centimeters (cm) to about 6 cm (e.g., about 2.5 cm to about 4 cm or about 4.5 cm). The embolic filter 610 may include any suitable size or diameter to accommodate anatomical variability in the patient's body cavity 1292 (see Fig. 12A ).

[0100] FIG. 7A to FIG. 7C Another embodiment of an embolic protection device 700 is shown, which includes a catheter 702, an embolic filter 710, a removable outer sheath 712, and an actuation mechanism for operating the embolic filter 710. A portion of the catheter 702 terminates in a fixed inner catheter 750 at a head 752 that can be slidably received and supported. The fixed inner catheter 750 can be made of a thick, hard material to increase rigidity and provide a protective layer or support layer around the catheter 702. The embolic filter 710 is disposed around the fixed inner catheter 750 and is configured to self-expand into a fixed inner catheter 750 when not restricted or constrained by the outer sheath 712. Fig. 7A Radially expanded configuration shown.

[0101] The embolic filter 710 includes a frame 724 and a filter medium 726. The frame 724 defines a distal opening 740 of the embolic filter 710 and includes a movable portion 730 for controlling the size or diameter of the distal opening 740. The embolic filter 710 extends proximally from the distal opening 740 to a closed proximal end 742. The frame 724 also includes a fixing portion 732 for attaching the frame 724 to a fixed inner catheter 750 at a position adjacent to the closed proximal end 742 of the embolic filter 710. In some embodiments, the embolic protection device 700 is similar to Figures 6A-6G The embolic protection device 600 is similar to the embolic protection device 600 , but with an additional actuation mechanism.

[0102] The actuation mechanism includes an inner catheter 756 and an outer catheter 758. The inner catheter 756 slides on the fixed inner catheter 750. The outer catheter 758 slides on the inner catheter 756. Movement of the inner catheter 756 and the outer catheter 758 relative to the fixed inner catheter 750 controls the size or diameter of the embolic filter 710, as will be described in more detail below.

[0103] The embolic protection device 700 also includes a push wire 722 coupled to a distal portion 764 of the outer catheter 758. The push wire 722 can be longitudinally moved between a fully retracted state, a partially advanced (or partially retracted) state, and a fully advanced state through the outer catheter 758. The push wire 722 is further coupled to a movable portion 730 of the frame 724. Moving the outer catheter 758 relative to the fixed inner catheter 750 translates into moving the push 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.

[0104] In various embodiments of the embolic protection device 700, as described above, the aforementioned device components can be coupled to each other 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 push 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 fixed inner catheter 750. Additionally or alternatively, the device components can be bonded together with a biocompatible adhesive.

[0105] The actuation mechanism also includes a top guide 760 and a bottom guide 762 for guiding the deflection and extension of the frame 724 so that the distal opening 740 of the embolic filter 710 faces the distal end (or working end) of the device 220 when it is expanded. In some embodiments, the top guide 760 and the bottom guide 762 respectively keep the movable portion 730 and the fixed portion 732 of the frame 724 straight. The top guide 760 and the bottom guide 762 are arranged at opposite points around the fixed inner catheter 750 and have respective portions arranged along the fixed 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 away from the distal portion 766 is slidably engaged with the fixed inner catheter 750 at or near the closed proximal end 742 of the embolic filter 710. For example, a portion of the top guide 760 slides along the fixed inner conduit 750 under the filter media 726 and through the closed proximal end 742 of the embolic filter 710. The bottom guide 762 is fixedly attached to the fixed inner conduit 750 at or near the closed proximal end 742 of the embolic filter 710.

[0106] At the distal opening 740 of the embolic filter 710, the top guide 760 and the bottom guide 762 are movable away from the fixed inner catheter 750. The top guide 760 can slidably receive the movable portion 730 of the frame 724, while the bottom guide 762 can receive 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 embolic filter 710 to the distal opening 740) to flare or bend outward from the fixed inner catheter 750, thereby giving the embolic filter 710 an overall funnel-shaped appearance. The top guide 760 and the bottom guide 762 can also support the filter media 726 between the distal opening 740 and the closed proximal end 742 of the embolic 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.

[0107] Fig. 7A Further shown is the outer sheath 712 fully retracted over the embolic filter 710 and exposing the embolic filter 710. The inner catheter 756 and the outer catheter 758 are in their initial positions (labeled "A" in the figure) relative to the fixed inner catheter 750. With the embolic filter 710 unsheathed, the movable portion 730 and the fixed portion 732 of the frame 724 are bent outwardly and away from the fixed inner catheter 750 along with the top guide 760 and the bottom guide 762. This causes the distal opening 740 of the embolic filter 710 to be at a certain angle relative to the fixed inner catheter 750. For example, the frame 724 and the fixed inner catheter 750 are at an angle of 45 degrees or less. At this stage of deployment, the embolic filter 710 is in a self-expanding configuration with the frame 724 unbent.

[0108] 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 advanced distally in unison over the fixed inner catheter 750. The inner catheter 756 and the outer catheter 758 move from their initial positions (labeled "A" in the drawings) to their intermediate positions (labeled "B" in the drawings) relative to the fixed inner catheter 750. The concerted movement of the inner catheter 756 and the outer catheter 758 advances the push wire 722 and the top guide 760 together, thereby longitudinally pushing the movable portion 730 of the frame 724 in the distal direction (forward direction). This rotates the distal opening 740 of the embolic filter 710 into an orientation that is generally perpendicular to the longitudinal axis of the fixed inner catheter 750 and expands the distal opening 740 to a first size (e.g., approximately 25 mm in diameter).

[0109] Figure 7CThe distal opening 740 is shown fully expanded to a second size greater than the first size. The outer catheter 758 is advanced distally over the inner catheter 756 and the fixed inner catheter 750. The outer catheter 758 is moved from its intermediate position (labeled "B" in the figure) to its final position (labeled "C" in the figure) relative to the fixed inner catheter 750 without movement of the inner catheter 756. Continued distal movement of the outer catheter 758 moves the push wire 722 without moving the top guide 760. The length of the movable portion 730 of the frame 724 extends radially away 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).

[0110] FIG. 8A to FIG. 8F An embodiment of an embolic protection device 800 is shown, which includes a catheter 802, an embolic filter 810, a removable outer sheath 812, and a handle 870 for manually operating the embolic filter 810. Figure 8B In the embodiment, the embolic protection device 800 also includes the same Figures 7A-7C The push wire 822, filter frame 824, filter media 826, movable portion 830, fixed portion 832, fixed inner catheter 850, inner catheter 856, outer catheter 858, top guide 860, and bottom guide 862 are arranged in a configuration similar to that described. For example, the push 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 is similar to the embolic protection device 700 , but with the addition of a handle 870 .

[0111] Fig. 8A A handle 870 is shown having a first slider 872 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 collapse / recover the embolic filter 810. The handle 870 also includes a second slider 874 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).

[0112] In some embodiments, the catheter 802 is Figure 8BThe pigtail catheter shown in and described in this application. The catheter 802 includes a distal portion 804, which is configured to present a generally arcuate shape that is at least semicircular. In some embodiments, the distal portion 804 of the catheter 802 includes one or more radiopaque markers 806. The sidewall of the catheter 802 may optionally include one or more orifices 808 in the distal portion 804, which are configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, etc.) to the body cavity.

[0113] The 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 can be configured to receive a guide wire 1290 (see Fig. 12A and 12B ), which can be moved longitudinally through the lumen to coil or straighten the distal portion 804 of the catheter 802 depending on whether the guidewire is retracted (to coil the distal portion) or extended (to straighten the distal portion). The orifice 808 and the lumen 818 can be in fluid communication with each other to deliver one or more fluids to the body cavity as described above.

[0114] like Figure 8B As shown, the example of catheter 802 is partially surrounded toward its proximal side by a fixed inner catheter 850 that terminates at a head 852 proximal to the distal portion 804 of the catheter 802. The fixed inner catheter 850 can be made of a thick, hard material to increase rigidity and provide a protective layer or support layer around the catheter 802.

[0115] Figure 8C An example of a handle 870 is shown (with the handle cover removed for clarity) that includes a sheath engagement mechanism 876 configured to advance or retract the outer sheath 812 by movement of the first slider 872. The outer sheath 812 is coupled to the sheath engagement mechanism 876. The outer sheath 812 and the sheath engagement mechanism 876 may be coupled using any number of suitable means (e.g., fasteners and / or adhesives) or techniques (e.g., sonic welding, solvent welding, and overmolding).

[0116] The sheath engagement mechanism 876 may be located within the handle 870 in a distal initial position ( Figure 8C shown) and the proximal final position ( Fig.8D The initial position of the sheath engagement mechanism 876 corresponds to the outer sheath 812 being circumferentially disposed around at least a portion of the embolic filter 810 and the embolic filter 810 being housed in a collapsed configuration. The final position of the sheath engagement mechanism 876 corresponds to the outer sheath 812 being longitudinally retracted over the embolic filter 810 and the embolic filter 810 being deployed in a self-expanding configuration.

[0117] The sheath engagement mechanism 876 can be selectively operated by the first slide 872. For example, the operator presses the first slide 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 ) to the final position (as shown in Fig.8D ). The operator uses their thumb to move the first slider 872 proximally to retract the outer sheath 812 and expose the embolic filter 810. To collapse / recover the embolic filter 810, the operator moves the first slider 872 distally and advances the outer sheath 812 over the embolic filter 810.

[0118] Figure 8C The example of the handle 870 shown in FIG. 8 also includes an engagement mechanism 878 configured to change the size or diameter of the distal opening 840 of the embolic filter 810 by moving the second slider 874. The engagement mechanism 878 includes a top puller 880 and a bottom puller 882. The top puller 880 is coupled to the proximal portion of the outer catheter 858, while the bottom puller 882 is coupled to the proximal portion of the inner catheter 856 (e.g., Fig.8F as shown).

[0119] The engagement mechanism 878 may be in an initial (proximal) position within the handle 870 (eg, Figure 8C and 8D as shown), the middle position (as shown Fig. 8E shown) and final (distal) position ( Fig.8F The initial position of the engagement mechanism 878 corresponds to the embolic filter 810 being in a self-expanded configuration in which the filter frame 824 is not deflected (or bent). The intermediate position of the engagement mechanism 878 corresponds to the embolic filter 810 being in a partially expanded configuration in which 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 being in a fully expanded configuration in which the filter frame 824 extends in the radial direction.

[0120] The engagement mechanism 878 can be selectively operated by the second slide member 874. For example, when the engagement mechanism 878 is in the initial position (eg Fig.8D In the case of the second slider 874 being pressed downwardly (not shown), the user presses the second slider 874 downwardly. The applied force causes the protrusion (not shown) extending from the second slider 874 to move downwardly through the hole (not shown) in the top pull 880 and into the recess (not shown) of the bottom pull 882.

[0121] exist Fig. 8E In, with reference Figure 8BIn conjunction, with the second slider 874 depressed and engaged with both the top pull 880 and the bottom pull 882, the operator uses their thumb to move the second slider 874 distally to advance the outer catheter 858 and the inner catheter (hidden from view) together. The concerted movement of the outer catheter 858 and the inner catheter causes the push wire 822 and the top guide 860 to move together (i.e., in unison). This in turn causes the movable portion 830 to longitudinally advance in the distal direction (forward direction) and expand the distal opening 840 of the embolic filter 810.

[0122] The distal opening 840 continues to expand as the second slide 874 moves distally until the engagement mechanism 878 reaches the Fig. 8E In the intermediate position, the distal opening 840 has a first size (e.g., a diameter of about 25 mm), and the second slide 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 recess of the bottom pull 882. The second slide 874 is disengaged from the bottom pull 882, but remains engaged with the top pull 880. It may be convenient to consider the engagement between the top pull 880 and the bottom pull 882 as temporary.

[0123] exist Fig.8F In, with reference Figure 8B In conjunction with the above, the operator continues to move the second slide 874 distally to advance the outer catheter 858 further in the distal direction. With the bottom puller 882 disengaged, the inner catheter 856 and the top guide 860 are fixed in place, and the push wire 822 is advanced further in the distal direction. As a result, the length of the movable portion 830 extends radially out of the top guide 860 (i.e., beyond the plane of the page), and further expands the distal opening 840 of the embolic filter 810 to the next size (e.g., about 30 mm in diameter). When the engagement mechanism 878 is in a position such as Fig.8F In the final position shown, the distal opening 840 is expanded to its maximum size (eg, about 40 mm in diameter). To restore the embolic filter 810, the above-referenced steps are reversed. Figures 8C-8F The process described.

[0124] In some embodiments, the wire of the embolic protection device described in the present application, for example Figure 1B The pull wire 122 of the embolic protection device 100 or Figure 6B The push wire 622 of the embolic protection device 600 includes a metal material, such as stainless steel. Alternatively, the wire may include 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 is flexible but has sufficient rigidity to be used when the pull wire is similar to the above reference Figure 1C and Figure 1D When retracted in the manner described, the embolic filter frame is deflected (or bent) in the proximal direction. In the case where the wire is a push wire, similar to Figure 6B The push wire 622 is flexible but has sufficient rigidity to deflect / bend the push wire embolic filter frame in the distal direction when the push wire is advanced, and when the push wire is pushed in the same direction as in the above reference Figure 6D-6F When advancing in a similar manner, the frame is extended in the radial direction.

[0125] In some embodiments, the filter media (e.g. Figure 1A Filter media 126 or Figure 6B The filter medium 626 includes a woven mesh, such as a woven nickel titanium alloy 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 about 100 microns to about 150 microns (e.g., about 125 microns).

[0126] In some embodiments, an embolic filter (e.g. Figure 1B Embolic filter 110 or Figure 6B The embolic filter 610 includes an anti-embolic coating (eg, a heparin coating or other coating containing a thrombin or platelet inhibitor) to help reduce embolism.

[0127] The embolic filter is configured to Figure 1A Outer sheath 112 or Fig. 6A When restricted or constrained by a deployment device such as an outer sheath 612, the self-expanding Figure 1B and 1C as well as Figure 6B and Figure 6C The radially expanded configuration shown in .

[0128] The deployment mechanism includes an outer sheath (e.g. Figure 1A A removable outer sheath 112 or Fig. 6A In some embodiments of the removable outer sheath 612, the outer sheath is configured to be disposed circumferentially 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 Fig. 6A602 and embolic filter 610). The outer sheath is configured to contain or accommodate 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 a proximal direction) to deploy the embolic filter and longitudinally advanced (i.e., longitudinally moved in a 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.

[0129] In some embodiments, the embolic filter (e.g. Figure 1A The embolic filter 110 and Fig. 6A The embolic filter 610 is configured to be placed within an outer sheath (e.g. Figure 1A The outer sheath 112 and Fig. 6A 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 of the filter element 100 is presented in a generally closed configuration, thereby isolating or substantially isolating the filtered material.

[0130] In some embodiments, the catheter of the embolic protection device described herein (e.g. Figure 1A The catheter 102 and Fig. 6A The catheter 602 may include a flexible material to facilitate movement within a body cavity (e.g., Fig. 9A The body cavity 992 and Fig. 12Abody cavity 1292) can be manipulated. For example, in some embodiments, the catheter includes a metal or a metal alloy. In other embodiments, the catheter includes a polymer (e.g., polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), a plastic material, any combination thereof, etc.). In some embodiments, the catheter includes a metal reinforced plastic (e.g., including nickel titanium alloy, 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 includes a braided reinforced tubing to facilitate increasing the strength of the catheter. In some embodiments, the catheter includes a braided catheter shaft, which includes 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 include a braided layer, which can increase the flexibility of the catheter. In some embodiments, the catheter includes a lubricating coating, such as a coating with a low coefficient of friction, to facilitate allowing smoother navigation in a curved vascular system. In some embodiments, the catheter coating has anti-embolism properties to facilitate inhibiting embolism. 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 possible, for example depending on the size of the target body cavity of a particular patient. In some embodiments, the length of the catheter is between about 65 centimeters (cm) and about 135 cm. Other lengths are also possible, for example to allow the catheter to be inserted 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.

[0131] In some embodiments, the embolic protection device described herein may include one or more radiopaque marker bands located at the distal portion of the catheter. Figure 1A and Figure 1B The radiopaque marker 106 of the embolic protection device 100 is located at the distal portion 104 of the catheter 102. As another example, Fig. 6A and 6B The radiopaque marker 606 of the embolic protection device 600 is located at the distal portion 604 of the catheter 602. When the distal portion assumes 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 so that when the distal portion assumes its generally arcuate configuration, the marker band is at the most distal point of the catheter, i.e., actually beyond the distal end of the catheter (e.g., beyond the distal end of the catheter). Figure 1A and 1B The distal end 116 of the catheter 102 shown in FIG. Fig. 6A and 6B 616 of the catheter 602 shown in FIG.

[0132] Radiopaque markers include radiopaque materials such as platinum, tantalum, tungsten, palladium, and / or iridium. Other radiopaque materials are also possible. 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 to be radiopaque. In some embodiments, the distal portion of the catheter (e.g. Figure 1A and 1B The distal portion 104 of the catheter 102 and Fig. 6A and 6B The distal portion 604 of the catheter 602 may be filled with a radiopaque material so that the entire distal portion may be seen using imaging techniques.

[0133] In some embodiments, the outer sheath of the embolic protection device described herein comprises a hollow tube configured to circumferentially surround at least a portion of the catheter. Figures 1A to 1F The outer sheath 112 of the embolic protection device 100 or Figures 6A-6G The outer sheath 612 of the embolic protection device 600 is shown. The outer sheath is longitudinally movable relative to the catheter and is configured to at least partially contain or accommodate the embolic filter in a folded configuration when circumferentially surrounding the embolic filter, such as Figure 1A and Fig. 6A The outer sheath is longitudinally and proximally retractable to release the embolic filter to an expanded, open configuration when not contained by the outer sheath.

[0134] In some embodiments, the outer sheath extends proximally to the proximal end of the catheter (e.g. Figure 1A The proximal end 114 of the catheter 102 shown in FIG. Fig. 6A The outer sheath is provided at the proximal end 614 of the catheter 602 shown in the figure so that a user can directly grasp and manipulate the outer sheath. In some embodiments, the outer sheath extends proximally over only a portion of the catheter, and an auxiliary device (e.g., a push rod such as found in a stent deployment system) is coupled to the outer sheath (e.g., coupled to the proximal end of the outer sheath) to allow indirect manipulation of the outer sheath. Manipulation of the outer sheath can be mechanical, electronic, manual, a combination thereof, etc.

[0135] In some embodiments, the embolic protection device described herein may have a longitudinally extending groove (not shown) along its outer surface. Figure 1B The embolic protection device 100 includes a longitudinally extending groove along the catheter 102, along the support catheter 150, or along the deployment mechanism (eg, outer sheath) 112. In another example, Figure 6BThe embolic protection device 600 includes a longitudinally extending groove along the catheter 602, along the support catheter 650, or along the deployment mechanism / outer sheath 612. In some embodiments, the groove can extend substantially from the proximal end of the embolic protection device to the distal end. The groove can be used to guide another catheter device alongside the embolic protection device. For example, the groove 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 beyond the embolic protection device while the embolic filter is deployed, for example, as Fig.13A As shown.

[0136] The device according to the disclosure of the present application may include: Figures 1A-1F , Figure 2A and 2B , Figures 3A-3D , Figures 4A-4C , Figure 5A and 5B , Figures 6A-6G , Figures 7A-7C as well as Figures 8A-8F Some or all of the features of embolic protection devices 100 , 200 , 300 , 400 , 500 , 600 , 700 , and 800 shown and described herein in various combinations.

[0137] 3. Methods for capturing embolic debris

[0138] Another aspect of the present invention provides a method 900 for capturing embolic debris during a closed heart medical procedure (e.g., an aortic valve replacement procedure) using an embolic protection device of the present invention (e.g., the embolic protection device 100, 200, 300, 400, or 500 described herein), such as Figures 9A-9E The step-by-step approach is shown in .

[0139] refer to Fig. 9A In one embodiment, a guide wire 990 is percutaneously inserted into a body cavity 992 of a patient, such as a femoral artery, a radial artery, a brachial artery, or a subclavian artery, and navigated to a desired anatomical location, such as the ascending aorta. The guide wire 990 may be a J-shaped wire having a diameter of about 0.035 inches (about 0.089 centimeters). Other types and sizes of wires 990 useful for the method are also possible.

[0140] 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 in the lumen 118 of the catheter 102 at the distal portion 104 of the catheter 102, the distal portion 104 of the catheter is straightened or assumes a curved portion of the guide wire 990. Fig. 9AAs shown, the distal end 116 of the catheter 102 is inserted into a body cavity 992 by tracking the 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 embolic protection device 100, so that the embolic protection device 100 can track over the guide wire 990. The inner surface of the lumen 118 and / or the outer surface of the guide wire 990 can include a lubricious coating to reduce friction during tracking. When the catheter 102 is inserted into the patient's body and navigated within the patient's body, the guide wire 990 keeps the distal portion 104 of the catheter 102 substantially straight (e.g., in a generally arcuate state).

[0141] The radiopaque marker 106 is used to visualize and locate the distal portion 104 of the catheter 102 during tracking. The guidewire 990 is retracted, i.e., longitudinally moved a sufficient distance in the proximal direction to allow the distal portion 104 of the catheter 102 to assume a generally arcuate shape, such as Fig. 9B As shown. The distal portion 104 of the catheter 102 is positioned at a desired anatomical landmark, for example, the lower border of the non-coronary cusps of the aortic valve. When the distal portion 104 assumes its generally arcuate shape, a radiopaque marker 106 is positioned on the most distal portion of the distal portion 104. In some embodiments, the distal portion 104 of the catheter 102 can be injected with a radiopaque material so that the entire distal portion 104 can be seen using imaging techniques.

[0142] In some embodiments of the method, the proximal end 114 of the catheter 102 is connected to a contrast agent injector, and contrast agent is injected into the lumen 118 of the catheter 102, for example, to visualize the anatomical structures surrounding the device 100. The contrast agent material exits the lumen 118 of the catheter 102 through an opening at the distal end 116 of the catheter 102 and / or through one or more orifices 108 in the sidewall of the catheter 102. Injecting contrast agent can help visualize and locate the catheter 102.

[0143] In some embodiments, a second guidewire is percutaneously inserted into a second body lumen (e.g., 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, a valve repair system, or a radiofrequency ablation system. Once the second catheter and associated device or instrument are properly positioned, the outer sheath 112 of the catheter 102 is retracted proximally longitudinally, thereby presenting the embolic filter 110 as shown in FIG. Fig. 9C Shown in expanded deployed configuration.

[0144] Next, the pull wire 122 can be retracted to bend the frame 124 of the embolic 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., the pull wire is fully retracted), as shown in FIG. Fig.9D and 9EAs shown, the distal opening 140 of the embolic filter 110 can be substantially perpendicular to the catheter 102 and can be transversely across the body cavity 992, approximately perpendicular to the longitudinal axis of the body cavity 992. The fully curved configuration can engage the body cavity 992, thereby capturing the embolic debris 994 in the embolic filter 110 without allowing the embolic debris to propagate around the outside of the embolic filter 110. A second guidewire and / or a 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 cavity wall, thereby stabilizing the catheter 102. Then, the procedure can be performed, and the embolic debris that is dislodged or enters the bloodstream during the procedure is captured by the embolic filter 110.

[0145] Following the procedure, the pull wire 122 is advanced and the outer sheath 112 is advanced longitudinally and distally to recapture the embolic filter 110, return the frame to the unbent configuration, return the embolic filter 110 to the folded configuration, and capture any embolic debris 994 contained within the embolic filter 110 (see Fig.9E ). The second catheter and catheter 102 can then be withdrawn from the patient. The catheter 102 can be retracted over the guidewire 990, or without straightening the distal portion 104 of the catheter 102, because the curved shape of the distal portion 104 is atraumatic to the blood vessel.

[0146] In some embodiments, the surgery performed is a heart valve replacement surgery, such as an aortic valve replacement surgery. 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.

[0147] 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.

[0148] 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. Fig.13A As shown.

[0149] Fig.10Another embodiment of a method 1000 for deflecting and capturing embolic debris using an embolic protection device 1001 during a medical procedure is shown. Figures 3A-3D 1001, but has an intermediate tube 1030. The embolic protection device 1001 also includes an embolic filter 1010 that is movably coupled to the 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 that is 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.

[0150] The embolic protection device 1001 further includes an outer sheath (not shown) 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 collapsed configuration or an expanded configuration that is deployed or partially deployed.

[0151] Method 1000 includes the following steps similar to those described above. 9A to 9E In the manner of the described method 900, an embolic protection device 1001 is used to capture emboli. For example, the distal end 1016 of the catheter 1002 is inserted into the patient's body cavity 1080 by tracking the lumen 1018 of the catheter 1002 over a guide wire previously inserted percutaneously into the body cavity 1080. When the catheter 1002 is inserted into the patient's body and navigated within the patient's body, the guide wire keeps the distal portion 1004 of the catheter 1002 substantially straight (e.g., in a generally arc-shaped state). The 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 the desired anatomical landmark (e.g., the inferior border of the non-coronary cusps of the aortic valve), the guidewire is retracted a sufficient distance to allow the distal portion 1004 of the catheter 1002 to assume a generally arcuate shape, such as Fig.10 shown.

[0152] The longitudinal position of the embolic filter 1010 within the body cavity 1080 can be adjusted by simultaneously moving the intermediate tube 1030 and the outer sheath. When the embolic filter 1010 is in the desired longitudinal position in the body cavity 1080, the intermediate tube 1030 remains fixed, and the outer sheath is retracted to deploy the embolic filter 1010. Next, the pull wire 1022 is retracted to bend the frame 1024 and open the embolic filter 1010 to capture the embolus.

[0153] The method 1000 also includes deflecting the embolus. The embolic protection device 1001 also includes a device similar to FIG. 4A to FIG. 4C Deflector 1060 is shown. Once the embolic 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 a subsequent medical procedure, the deflector 1060 can prevent emboli from entering the carotid artery, and the embolic filter 1010 can capture emboli deflected by the deflector 1060 before they propagate to other parts of the patient's body. The method 1000 can also be performed using various other embolic protection devices (e.g., embolic protection devices as described in the present application) and deflector devices, which can vary in their configuration and how they are introduced into the body and navigated to the aortic arch.

[0154] Fig.11 Another embodiment of a method 1100 for deflecting and capturing embolic debris is shown. An embolic protection device 1101 includes a catheter 1102 (e.g., a pigtail catheter) having a radiopaque marker 1106 and an embolic filter 1110 disposed about the catheter 1102, the latter being similar to Figures 1A-1F The embolic 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 that is adjacent to the distal portion 1104 of the catheter 1102.

[0155] Method 1100 includes performing the following steps similar to those described above. Figures 9A-9EIn the manner of the described method 900, an embolic protection device 1101 is used to capture an embolus. 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 over a guide wire previously inserted percutaneously into the body cavity 1180. When the catheter 1102 is inserted into the patient's body and navigated within the patient's body, 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 contrast agent through an orifice 1108 in the distal portion 1104 of the catheter 1102.

[0156] Once positioned at the desired anatomical landmark (eg, the inferior border of the non-coronary cusps of the aortic valve), the guidewire is retracted a sufficient distance to allow the distal portion 1104 of the catheter 1102 to assume a generally arcuate shape, such as Fig.11 The outer sheath (not shown) of the catheter 1102 is retracted proximally in the longitudinal direction, thereby allowing the embolic filter 1110 to assume an expanded deployed configuration, such as Fig.11 Next, the pull wire 1122 is retracted to bend the frame 1124 and open the embolic filter 1110 to capture the embolus.

[0157] Method 1100 also includes deflecting the embolism with a deflector 1160. As shown, the deflector 1160 is mounted on the shaft 1162 and is contained in the guide 1168 during insertion. The guide 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 and pulled back from the guide 1168 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 may be introduced and deployed before the catheter 1102 is guided to the aortic arch. In subsequent medical procedures, the deflector 1160 can prevent the embolism from entering the carotid artery, and the embolic filter 1110 can capture the embolism deflected by the deflector 1160 before it propagates to other parts of the patient's body. The method 1100 may also be performed using various other embolic protection devices and deflector devices, such as those described herein, which may vary in configuration and in how they are introduced into the body and directed to the aortic arch.

[0158] 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 ...

[0159] 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.

[0160] 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.

[0161] Some embodiments include at least partially longitudinally retracting the deployment mechanism and allowing the self-expanding embolic filter to assume an expanded, deployed configuration.

[0162] 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.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] In some embodiments, the deployment mechanism is a sheath disposed circumferentially around at least a portion of the catheter.

[0167] 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.

[0168] 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.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] Another aspect of the present invention provides a Figures 12A-12D12 is a method 1200 for capturing embolic debris during a closed heart medical procedure (eg, an aortic valve replacement procedure) using an embolic protection device of the present invention (eg, embolic protection device 600, 700, or 800 as described herein).

[0173] refer to Fig. 12A In one embodiment, a guide wire 1290 is percutaneously inserted into a body cavity 1292 of a patient, such as a femoral artery, a radial artery, a brachial artery, or a subclavian artery, and navigated to a desired anatomical location, such as the ascending aorta. The guide wire 1290 may be a J-shaped wire having a diameter of approximately 0.035 inches (approximately 0.089 centimeters). Other types and sizes of guide wires useful for this method are also possible.

[0174] In other embodiments, the proximal end of the guide wire 1290 is inserted into the opening at the distal end 616 of the catheter 602. When the guide wire 1290 is in the lumen 618 of the catheter 602 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 shown in FIG. Fig. 12A As shown. The outer diameter of the guide wire 1290 is smaller than the inner diameter of the embolic protection device 600, so that the embolic protection device 600 can track on the guide wire 1290. The inner surface of the lumen 618 and / or the outer surface of the guide wire 1290 may include a lubricious coating to reduce friction during tracking. When the catheter 602 is inserted into the patient's body and navigated within the patient's body, the guide wire 1290 keeps the distal portion 604 of the catheter 602 substantially straight (e.g., in a generally arcuate state).

[0175] Radiopaque markers 606 are used to visualize and locate the distal portion 604 of the catheter 602 during tracking. The guidewire 1290 is retracted, i.e., moved longitudinally a sufficient distance in the proximal direction to allow the distal portion 604 of the catheter 602 to assume a generally arcuate shape, such as Fig. 12B 6. The distal portion 604 of the catheter 602 is positioned at a desired anatomical landmark, for example, at the lower border of the non-coronary cusps of the aortic valve. When the distal portion 604 assumes its generally arcuate shape, the radiopaque marker 606 is located on 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 so that the entire distal portion 604 can be seen using imaging techniques.

[0176] 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 anatomical structures surrounding 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 may aid in visualization and positioning of the catheter 602.

[0177] 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, a valve repair system, or a radiofrequency ablation system. Once the second catheter and associated device or instrument are properly positioned, the outer sheath 612 is longitudinally retracted in a proximal direction, thereby allowing the embolic filter 610 to assume a self-expanding deployed configuration, such as Fig. 12C shown.

[0178] Next, the push wire 622 can be advanced to bend the filter frame of the embolic filter 610. The push wire and filter frame are FIG. 12A to FIG. 12D Not shown, but can be found in Figure 6B-6F 622 and frame 624, respectively. The push wires cause the filter frame to bend outward in the distal longitudinal direction and in the transverse direction. Fig.12D As shown, in the bent configuration (i.e., with the pull wire advanced in the distal direction), as Fig.12D As shown in FIG, the distal opening 640 of the embolic filter 610 can be generally perpendicular to the catheter 602 and can transversely span the body cavity 1292, generally perpendicular to the longitudinal axis of the body cavity 1292. To accommodate the size of the body cavity 1292, the push wire can be further advanced to extend the frame in a radial direction and further expand the embolic filter 610.

[0179] The curved configuration can engage the body lumen 1292, thereby capturing embolic debris 1294 in the embolic filter 610 without allowing the embolic debris to propagate around the exterior of the embolic filter 610. A second guidewire and / or a 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 so that blood flows through the embolic filter 610 before flowing into the carotid arteries or descending aorta. In some embodiments, when the embolic filter 610 is deployed, the catheter 602 is placed against the lumen wall, thereby stabilizing the catheter 602. The procedure can then be performed, and embolic debris 1294 that is dislodged or otherwise formed in the bloodstream is captured by the embolic filter 610 during the procedure.

[0180] After the procedure, the push wire 622 is retracted and the outer sheath 612 is advanced longitudinally and distally to recapture the embolic filter 610, return the filter frame to the unbent configuration and return the embolic filter 610 to the folded configuration. Any embolic debris 1294 contained within the embolic filter 610 is captured (see Fig.12D ). The second catheter and catheter 602 can then be withdrawn from the patient. Since the curved shape of the distal portion 604 is atraumatic to the blood vessel, the catheter 602 can be retracted over the guidewire 1290 or without straightening the distal portion 604 of the catheter 602.

[0181] 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's body and navigated to the aortic valve, as described herein and as described herein. Figures 12A-12D As shown. The radiopaque marker 606 helps to delineate the lower border of the non-coronary cusp to aid in the correct placement of the percutaneously implanted replacement aortic valve. Once the catheter 602 is positioned, a second guide wire can be percutaneously inserted into a second body cavity and navigated to the level of the ascending aorta or left ventricle. The balloon can be tracked over the second guide wire to the aortic valve. The outer sheath 612 is then retracted to deploy the embolic filter 610, and the push wire 622 is advanced to bend the frame 624 into a curved configuration. And, if it is necessary to engage the intracoronary body cavity 1292, the push wire 622 can be further advanced to extend the frame 624 to an extended configuration. Balloon inflation of the valve can then be performed, and the embolic filter 610 captures embolic debris 1294 that has been dislodged in the bloodstream during surgery or otherwise. After the balloon is pre-expanded, the push 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 a 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 re-deploy the embolic filter 610, and the push wire 622 is advanced again. The radiopaque marker 606 allows the user to properly position 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 push 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 the embolic filter 610 and embolic debris 1294 are recaptured.

[0182] In other embodiments, the surgery is a heart valve repair surgery. The methods described herein may also be applicable to mitral valve repair or replacement surgery. In some embodiments, the surgery is a radiofrequency ablation surgery, for example to treat atrial fibrillation. In some embodiments, the surgery is a catheterization surgery or a structural heart surgery.

[0183] In other embodiments, methods of capturing embolic debris as described herein may include inserting a second catheter device through 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 Fig.13A shown.

[0184] 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 an inner cavity extending from the proximal end of the catheter to the distal end of the catheter, wherein the inner cavity is configured to accommodate a guide wire and a distal portion of the catheter, the distal portion presenting a generally arcuate shape of at least a semicircle 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; and a deployment mechanism disposed around at least a portion of the catheter, wherein the deployment mechanism is relatively For longitudinal movement of 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 connected to the embolic filter frame, wherein the wire is longitudinally movable relative to the catheter, the wire being configured to cause the frame to bend longitudinally toward the distal end of the catheter and bend laterally outward from the catheter when the wire is longitudinally advanced in the distal direction to a first position, so that the opening of the embolic filter generally faces the distal end of the catheter and expands to a first diameter, and when the wire is longitudinally advanced distally in the distal direction to a second position farther than the first position, the frame is extended radially outward from the catheter so that the opening of the embolic filter expands to a second diameter greater than the first diameter. The method also includes tracking the lumen of the catheter over a guide wire inserted percutaneously into the body cavity.

[0185] Other embodiments further include at least partially longitudinally retracting the guidewire from the lumen of the catheter such that a distal portion of the catheter assumes a generally arcuate shape that is at least semi-circular.

[0186] 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.

[0187] Other embodiments include at least partially longitudinally retracting the deployment mechanism and allowing the self-expanding embolic filter to assume the expanded deployed configuration.

[0188] 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.

[0189] 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 a first diameter that substantially spans the body lumen.

[0190] 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.

[0191] In other embodiments, the deployment mechanism is a sheath disposed circumferentially around at least a portion of the catheter.

[0192] 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.

[0193] 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.

[0194] 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.

[0195] 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 an inner cavity extending from the proximal end of the catheter to the distal end of the catheter, wherein the inner cavity is configured to accommodate a guide wire and a distal portion of the catheter, the distal portion presenting a generally arcuate shape of at least a semicircle 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 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 coupled to the self-expanding filter frame, wherein the wire is movable longitudinally.

[0196] 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 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.

[0197] Example

[0198] Example 1: Corpse Model

[0199] refer to Fig.13A and 13B The embolic protection device of the present invention (EPD-1) was tested in a human cadaver model to visually assess the ability of the device to cover all cerebral vessels with embolic filters when the intravascular device was placed side by side with the EPD-1 through the aorta. Fig.13A and 13B In this photo, the EPD-1 is deployed to cover the opening of a cadaver's cerebral blood vessel while the TAVR delivery system is passed over the filter. Fig.13A In the TAVR delivery system, the EPD-1 catheter follows longitudinal grooves on its outer surface. Fig. 13B In the experiment, the TAVR delivery system tracks outside of the groove of the EPD-1 catheter.

[0200] Example 2: Clinical research

[0201] refer to Fig.14 and FIG. 15A to FIG. 15J, the safety and performance of an embolic protection device according to the present invention ("EPD-1") during transcatheter aortic valve replacement (TAVR) procedures in human subjects were evaluated. The primary objective was to evaluate the performance and therapeutic effect of using the EPD-1 during TAVR with respect to procedure-related cerebral embolic burden, as determined by diffusion-weighted magnetic resonance imaging (DW-MRI). The secondary objective was to analyze the safety and type of captured debris from the EPD-1 filter after TAVR.

[0202] The study was designed as a multicenter, non-randomized clinical trial including up to 5 clinical sites to evaluate the performance and therapeutic effects of the use of the EPD-1 during TAVR with respect to procedure-related silent ischemic lesions and cerebral embolic burden as determined by DW-MRI studies performed before and after the procedure. Secondary objectives were to analyze the safety and type of captured debris from the EPD-1 filter after TAVR. The potential risk of neurologic compromise and stroke was assessed based on pre- and post-procedural neurological evaluations. The study population included up to thirty (30) subjects with severe native aortic stenosis who met the commercially accepted indication for TAVR and met the inclusion / exclusion criteria.

[0203] Primary test objectives: 1) Device performance: defined as successful insertion, placement, and removal of the 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 lesions detected by DW MRI 2-5 days after TAVR compared with baseline.

[0204] Secondary test targets: 1) The rate of major adverse cardiac and cerebrovascular events 30 days after the first TAVR procedure compared with historical data. Major adverse cardiac and cerebrovascular events (MACCE) are defined as: all-cause mortality; all strokes (major, minor, TIA); acute kidney injury (grade 3). 2) Clinical assessment of the subject's neurological status before and after the first procedure using the NIH Stroke Scale.

[0205] Eleven subjects participated in a multicenter, nonrandomized, prospective pilot study. The performance characteristics of the EPD-1 were evaluated after surgery and scored on a 5-point scale (1 = unacceptable, 5 = excellent). The mean performance of all patients for all characteristics of the EPD-1 was 4.8 at clinical site 1 and 3.4 at clinical site 2. The mean performance score of the EPD-1 performance for each evaluated characteristic (at each clinical site) was Fig.14 The features scored were: vessel access, tracking, sheath and deployment button use, positioning, rewrapping, removal, visualization during aortography, deployment, positioning, repositioning, retrieval, stability, in situ visibility, ease of deployment, and ease of wrapping.

[0206] The pre- to post-procedural aortic gradient measurements decreased by an average of 86.4% across all eleven (11) subjects, confirming the success of the TAVR treatment.

[0207] All subjects underwent DW-MRI before and after the procedure, and image evaluation was consistent with the identification of certain ischemic lesions. MRI was performed at baseline and pre-discharge (2-5 days) visits in 11 (11) subjects who underwent transcatheter aortic valve replacement (TAVR) surgery 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 agents are sensitive to water molecules and aid in the localization and quantification of fresh lesions. Lesion location, size, and volume were assessed for total lesion number, and 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.

[0208] A median number of lesions was 6 and a median lesion volume of 193.9 mm were observed in eleven (11) subjects. 3 Table 1 details the lesions by site. These results show that the number and volume of lesions were lower than in historical control groups and in clinical trials involving cleared and investigational embolic protection devices.

[0209] Table 1: Brain lesions by site for all patients in the clinical study (clinical sites 1 and 2).

[0210]

[0211] A detailed comparison of lesion number and volume between the clinical study of this Example 2 and clinical studies of comparable devices is provided in Table 2. These results suggest that protection with EPD-1 can reduce the number of ischemic lesions or reduce the volume of lesions, supporting the utility of this procedure.

[0212] Table 2: Comparison of EPD-1 performance with cleared and investigational devices.

[0213]

[0214] The time points at which MRI was performed varied between these studies. All patients in Example 2 underwent DW-MRI within 48 hours of surgery, and for the other reference studies, imaging was performed at longer time points. Since the appearance of high intensity during DW-MRI imaging is known to develop over time, these other reference studies may have observed larger lesion volumes if the DW-MRI was performed within 48 hours of surgery. However, in terms of reducing acute cerebral embolic burden, the EPD-1 was superior to the reference comparable devices. Although there were 3 patients with increased lesion counts, they were considered outliers due to recapture of the filter and post-expansion of the TAVR device. During these outlier procedures, the operators were concerned about the interaction of the balloon catheter with the filter frame due to the small anatomy of the aorta. This often resulted in the release of debris.

[0215] EPD-1 captured emboli in all procedures. Fig.16A and 16B Two examples of captured emboli are shown in the photographs. Fig.16A The photograph shows the embolus captured by EPD-1 of Example 2. Fig. 16B The photo shows the actual pathological findings of a 4.6 mm collagen fragment captured within the EPD-1 filter during the TAVR procedure. Neurological evaluation of all patients using the NIHSS at discharge and 30 days after surgery showed that all scores remained at baseline levels except for one patient who developed limb ataxia. No serious adverse events were recorded. Debris captured by the EPD-1's embolic filter included collagen, fibrin, emboli, and calcium.

[0216] The test targets are summarized in Table 3.

[0217] Table 3: Summary of test subjects from the clinical study of Example 2.

[0218]

[0219] Other Implementations

[0220] It should be understood that although the invention has been described in conjunction 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.

[0221] Those of ordinary skill in the art will understand that the specific devices and processes shown in the drawings and described in this specification are merely exemplary embodiments of the inventive concepts defined in the appended claims. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed in this application should not be considered restrictive unless the claims explicitly state otherwise. It should also be understood that the construction of the described invention and other components is not limited to any specific material. Unless otherwise described in this application, other exemplary embodiments of the invention disclosed in this application can be formed of a variety of materials.

[0222] Changes and modifications of the particularly described embodiments may be made without departing from the principles of the present invention, which is limited only by the scope of the appended claims, which is to be 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 guidewire; A self-expanding embolic filter is disposed around the catheter proximal to the distal end, wherein the embolic filter comprises a frame, wherein The frame defines an opening of the embolic filter, and The framework includes a fixing portion coupled to the catheter proximal to the distal end of the catheter, wherein the fixing portion does not move in the longitudinal direction, and a movable portion, the movable portion being continuous with the fixed portion of the frame; 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; a wire coupled to the movable portion of the frame, wherein the wire is movable longitudinally relative to the catheter and pushes the movable portion of the frame; The wire is configured to push the movable portion of the frame in a longitudinal direction and cause the frame to bend longitudinally toward the distal end of the catheter and laterally outward from the catheter when the wire is longitudinally advanced in a distal direction to a first position, so that an opening of the embolic filter faces the distal end of the catheter and expands to a first diameter; and The wire is configured to push the movable portion of the frame and extend the frame radially outward from the catheter when the wire is longitudinally advanced in the distal direction to a second position distally farther than the first position, so that the opening of the embolic filter expands to a second diameter greater than the first diameter.

2. The embolic protection device according to claim 1, wherein: The distal portion of the catheter assumes an arcuate shape that is at least semicircular when the guidewire is at least partially retracted.

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

4. The embolic protection device according to claim 1 or 2, wherein: The wire is configured to position the frame when longitudinally retracted to a proximal position such that an opening of the embolic filter defined by the frame is parallel to or at an angle less than 45 degrees relative to a longitudinal axis of the catheter.

5. The embolic protection device according to claim 1 or 2, wherein: The frame includes two sides; each side of the frame extends away from the catheter in a first lateral direction, then wraps around the opposite side of the catheter and extends in an opposite lateral direction before converging and merging to form an opening of the embolic filter, the opening having an elliptical, oval or circular shape.

6. The embolic protection device according to claim 1 or 2, further comprising an outer catheter disposed around at least a portion of the catheter and coaxial with the inner lumen of the catheter, wherein the outer catheter is longitudinally slidable on the catheter; and wherein the wire is coupled to a distal portion of the outer catheter such that the wire is moved by sliding the outer catheter over the catheter.

7. The embolic protection device according to claim 6, further comprising: an inner catheter disposed between the outer catheter and the catheter, wherein the inner catheter is longitudinally slidable on the catheter; as well as A guide is attached at one end to the distal portion of the inner catheter so as to be moved by sliding the inner catheter over the catheter, wherein the guide slidably receives the movable portion of the frame so as to flex the guide outwardly away from the catheter.

8. The embolic protection device according to claim 7, wherein: The guide is a top guide, and the embolic protection device further comprises a bottom guide attached at one end to the catheter, wherein the bottom guide and the top guide are arranged on opposite sides of the catheter, and wherein the bottom guide receives a fixed portion of the frame such that the bottom guide bends outwardly away from the catheter.

9. The embolic protection device according to claim 1 or 2, wherein: The embolic protection device has a handle, wherein the handle includes a mechanism configured to advance or retract the wire.

10. The embolic protection device according to claim 1 or 2, further comprising: a handle coupled to the proximal end of the catheter; a top puller coupled to the proximal portion of the outer catheter and movable longitudinally within the handle; a bottom puller coupled to the proximal portion of the inner catheter and movable longitudinally within the handle, wherein the bottom puller is in temporary engagement with the top puller; When the top and bottom pulls are engaged, the top and bottom pulls move in unison through movement of the slider, which in turn pushes the guide along with the movable portion of the frame in a longitudinal direction and expands the opening of the embolic filter to a first diameter; and When the top and bottom pulls are disengaged, the top pull is moved without the bottom pull by movement of the slider, which in turn pushes the movable portion of the frame in a radial direction and expands the opening of the embolic filter to a second diameter.

11. The embolic protection device according to claim 1 or 2, wherein: The catheter extends through the opening of the embolic filter.

12. The embolic protection device according to claim 2, wherein: The distal portion of the catheter includes a radiopaque marker.

13. The embolic protection device according to claim 12, wherein: The radiopaque marker includes one or more circumferential bands.

14. The embolic protection device according to claim 1 or 2, wherein: The frame includes a shape memory material.

15. The embolic protection device according to claim 1 or 2, wherein: The embolic filter includes a filter medium comprising a semi-permeable polyurethane material having a pore size of 100 microns to 150 microns.

16. The embolic protection device according to claim 1 or 2, wherein: The embolic protection device includes a longitudinal groove along an outer surface of the catheter, the longitudinal groove being configured to guide a second catheter device inserted alongside the embolic protection device.

17. The embolic protection device according to claim 1 or 2, wherein: The deployment mechanism includes a sheath disposed circumferentially around at least a portion of the catheter, wherein the sheath deploys the self-expanding embolic filter when the sheath is at least partially longitudinally retracted.

18. The embolic protection device according to claim 2, wherein: The distal portion of the catheter includes one or more apertures in communication with the lumen of the catheter.

19. The embolic protection device according to claim 1 or 2, wherein: As the wire is advanced longitudinally in the distal direction, the embolic filter transitions from self-expanding to partially expanding.

20. The embolic protection device according to claim 19, wherein: As the wire is further advanced longitudinally in the distal direction, the embolic filter transitions from partially expanded to fully expanded.

21. The embolic protection device according to claim 20, wherein: When the embolic filter transitions from partially expanded to fully expanded, the diameter of the embolic filter ranges between 25 mm and 40 mm.

22. The embolic protection device according to claim 1 or 2, wherein: The embolic filter is configured to self-expand to a first state less than a fully expanded state when the deployment mechanism is longitudinally retracted.

23. The embolic protection device according to claim 1 or 2, wherein: The wire inhibits self-expansion of the embolic filter.

24. The embolic protection device according to claim 2, wherein: The distal portion of the catheter includes a radiopaque material and also includes a plurality of radiopaque marker bands.

25. The embolic protection device according to claim 24, wherein: The radiopaque marker bands in the plurality of radiopaque marker bands have different widths.

26. The embolic protection device according to claim 1 or 2, further comprising: an inner catheter that can slide longitudinally on the catheter; and A guide is coupled to a distal portion of the inner catheter and is slidable therewith, wherein the guide receives the movable portion of the frame.

27. The embolic protection device according to claim 26, wherein: The proximal portion of the guide is coupled to the distal portion of the inner catheter, and wherein the distal portion of the guide is configured to bend outwardly.

28. The embolic protection device of claim 26, wherein: The guide is coupled to a first side of a distal portion of the inner catheter, the embolic protection device further comprising a second guide coupled to a second side of the distal portion of the inner catheter, the second side being opposite the first side, wherein the second guide receives a fixed portion of the frame.

Images