Conformable embolic filter

Abstract

A conformable embolic protection device comprising a filter body comprising a tubular porous mesh material having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said access port comprising an expandable opening configured to conform to at least one working catheter passing therethrough, a radially collapsible support coupled to a periphery of the downstream end of the filter body, a conformable section at the upstream end of the filter body, a catheter body having a distal end coupled to the radially collapsible support, and a delivery sheath having a lumen configured to receive and radially constrain the filter body.

Description

CONFORMABLE EMBOLIC FILTERCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 695,184, titled “CONFORMABLE EMBOLIC FILTER,” filed on September 16, 2024, and U.S. provisional patent application no. 63 / 786,233, titled “CONFORMABLE EMBOLIC DEFLECTOR,” filed on April 9, 2025, which are both herein incorporated by reference in their entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] The present disclosure relates to apparatus and methods for providing embolic protection in a patient’s vascular system. In particular, it relates to an embolic filter or a deflector that may be deployed in a patient’s aorta to protect the aortic arch vessels and downstream organs from potential emboli during a catheter-based interventional procedure.BACKGROUND

[0004] Cerebral embolism is a known complication of cardiac surgery, cardiopulmonary bypass and catheter-based interventional cardiology and electrophysiology procedures. Embolic particles, which may include thrombus, atheroma and lipids, may become dislodged by surgical or catheter manipulations and enter the bloodstream, embolizing in the brain or other vital organs downstream. Cerebral embolism can lead to neuropsychological deficits, stroke and even death. Other organs downstream can also be damaged by embolism, resulting in diminished function or organ failure.

[0005] Prevention of embolism would benefit patients and improve the outcome of these procedures. Given that potential emboli are often dislodged during catheter-based procedures, it would be advantageous to deploy an embolic protection system as part of a catheter-based vascular procedure, such as transcatheter aortic valve replacement (TAVR), or electrophysiology catheter, or transcatheter mitral valve replacement or repair (TMVR).- 1 -SG Docket No.: 14925-720.600

[0006] A specific sub-category of aortic embolic protection devices are devices with a cylindrical (or somewhat conical) shape to the filter portion, often in the region of the aortic arch. For purposes of this application, the word “cylindrical” shall have the meaning of either cylindrical or conical, i.e., a tubular filter structure with at least one open end at the upstream (“distal”) end, wherein its length is longer than its diameter. These devices can be simple cylindrical deflectors to prevent emboli from entering the cerebral vessels of the aortic arch, or they can incorporate an access port that allows the device to capture both cerebral and noncerebral emboli, while providing a pathway through which other procedural devices can pass through the filter.

[0007] Examples of such devices with a cylindrical section are the commercial FLOWer device (AorticLab) and devices in clinical development such as the Emboliner device (Emboline), the Emblok device (Innovative Cardiovascular Solutions), the CAPTIS device (Filterlex Medical), and the F2 device (EnCompass Technologies). These devices typically have a rigid perimeter frame to support the filtering element. Such a frame can provide inadequate sealing in various aortic arch geometries, which can leave gaps through which emboli can pass. This can result in sub-optimal embolic protection.

[0008] A specific sub-category of aortic embolic protection devices are so-called “deflectors” such as the commercial TriGuard device (Keystone Heart / Venus Medical) and devices in clinical development such as the Protembo device (Protembis) and the PointGuard device (Transaortic Medical). These deflector devices typically have a rigid perimeter frame. Such a frame can provide inadequate sealing in various aortic arch geometries, which can leave gaps through which emboli can pass. This can result in sub-optimal embolic protection. Others have attempted to address this deficiency through an elastic double frame design. However, the outermost portion of these devices is still a rigid frame. The reliability of a deflector for cerebral embolic protection can be improved through the design of a deflector with a conformable outer perimeter that more appropriately enhances the ability of the device to create a more complete seal in a variety of aortic anatomies.

[0009] Despite the various advancements in the field of embolic protection, challenges remain and further improvements to device performance are needed.SUMMARY OF THE DISCLOSURE

[0010] In general, in one embodiment, an embolic protection device may comprise a filter body including a tubular porous mesh material having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, wherein said access port may further include an expandable opening configured to conform to at least one - 2 -SG Docket No.: 14925-720.600working catheter passing therethrough. Further, the embolic protection device may further comprise a radially collapsible support that may be coupled to a periphery of the downstream end of the filter body, a conformable section at the upstream end of the filter body, a catheter body that may have a distal end coupled to the radially collapsible support, and a delivery sheath that may have a lumen configured to receive and radially constrain the filter body. Further still, the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

[0011] This and other embodiments may comprise one or more of the following features. In one aspect, the conformable section may include a different material from the filter mesh. In another aspect, the conformable section may include the same material as the filter mesh. In yet another aspect, the conformable section may have a length between 2mm and 20mm. In still another aspect, a nosecone may be coupled to the upstream end of the filter body. In another aspect, the nosecone may be expanded or collapsed. In yet another aspect, the nosecone may include a polymer balloon that may be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

[0012] In general, in one embodiment, an embolic protection device may comprise a filter body including a tubular porous mesh material having an open upstream end and an open downstream end, a radially collapsible support may be coupled to a periphery of the downstream end of the filter body, a conformable section at the upstream end of the filter body, a catheter body may have a distal end coupled to the radially collapsible support, and a delivery sheath may have a lumen configured to receive and radially constrain the filter body. Further, the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

[0013] This and other embodiments may comprise one or more of the following features. In one aspect, the conformable section may include different material from the filter mesh. In another aspect, the conformable section may include the same material as the filter mesh. In yet another aspect, the conformable section may have a length between 2mm and 20mm. In still another aspect, a nosecone may be coupled to the upstream end of the filter body. In another aspect, the nosecone may be expanded or collapsed. In an alternative aspect, the nosecone may include a polymer balloon that may be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.- 3 -SG Docket No.: 14925-720.600

[0014] In general, in one embodiment, an embolic protection device may comprise a filter body including a tubular porous mesh material having an open upstream end and a closed downstream end, with an opening at the downstream end to accommodate the introduction of a catheter therethrough, a radially collapsible support may be coupled to a periphery of the downstream end of the filter body, a conformable section at the upstream end of the filter body, a catheter body may have a distal end coupled to the radially collapsible support, and a delivery sheath may have a lumen configured to receive and radially constrain the filter body. Further, the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

[0015] This and other embodiments may comprise one or more of the following features. In one aspect, the conformable section may include a different material from the filter mesh. In yet another aspect, the conformable section may include the same material as the filter mesh. In still another aspect, the conformable section may have a length between 2mm and 20mm. In another aspect, a nosecone may be coupled to the upstream end of the filter body. In an alternative aspect, the nosecone may be expanded or collapsed. In another aspect, the nosecone may comprise a polymer balloon that may be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

[0016] In general, in one embodiment, an embolic protection device may comprise a panel made from a planar porous mesh material with a rigid perimeter frame, a closed upstream end, and a closed downstream end, a radially collapsible support may be coupled to a periphery of the downstream end of the panel, a conformable section may surround the perimeter frame, a catheter body may have a distal end coupled to the radially collapsible support, and a delivery sheath may have a lumen configured to receive and radially constrain the panel. Further, the catheter body may be distally advanced relative to the delivery sheath to release the panel from constraint and to allow the panel to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the panel back into the lumen of the delivery sheath.

[0017] This and other embodiments may comprise one or more of the following features. In one aspect, the conformable section may include a different material from the filter mesh. In another aspect, the conformable section may include the same material as the filter mesh. In yet another aspect, the conformable section may have a length between 2mm and 20mm. In still another aspect, a nosecone may be coupled to the upstream end of the panel. In another aspect, the nosecone may be expanded or collapsed. In still another aspect, the- 4 -SG Docket No.: 14925-720.600nosecone may include a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

[0018] In general, in one embodiment, an embolic protection device may comprise a filter body including a tubular porous mesh material having an open upstream end, an open downstream end, and an access port may be spaced inwardly from each of said ends, said access port may include an expandable opening configured to conform to at least one working catheter passing therethrough. Further, a nosecone may be coupled to the upstream end of the filter body. Further still, a delivery sheath may have a lumen configured to receive and radially constrain the filter body. In yet further aspects, the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

[0019] This and other embodiments may comprise one or more of the following features. In one aspect, the nosecone may be expanded or collapsed. In another aspect, the nosecone may include a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

[0020] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch may comprise providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the cylindrical filter body having an open upstream end, an open downstream end, an access port that may be spaced inwardly from each of said ends, a radially collapsible support that may be coupled to a periphery of the open downstream end of the cylindrical filter body, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section at the upstream end of the cylindrical filter body, advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter may be attached to the radially collapsible support on the cylindrical filter body while the cylindrical filter body remains in its radially constrained configuration to position the cylindrical filter body over the aortic arch, radially expanding the cylindrical filter body so that the porous mesh covers the patient's aortic side vessels, the upstream end of the cylindrical filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, and the radially collapsible support radially may expand to hold the open downstream end of the cylindrical filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side vessels, and advancing a first working catheter- 5 -SG Docket No.: 14925-720.600through the open downstream end of the cylindrical filter body and through the access port toward the heart.

[0021] This and other embodiments may comprise one or more of the following features. In one aspect, the method may further include advancing a second working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart. In another aspect, the method may include performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter. In still another aspect, the first working catheter may be introduced through a lumen in the deployment catheter and the second working catheter may be introduced in parallel to the deployment catheter. In yet another aspect, the first working catheter may introduce contrast media to an interventional site and the second working catheter may perform an interventional procedure. In an additional aspect, the interventional procedure may include delivery of a prosthetic aortic valve. In still another aspect, the deployment catheter may be advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body may include proximally retracting the delivery sheath relative to the deployment catheter. In another aspect, the method may further include retrieving the radially expanded cylindrical filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and draw the closed downstream end of the cylindrical filter body into the delivery sheath. In yet another aspect, retracting the deployment catheter to collapse the radially collapsible support may include retracting a tether present in a lumen of the deployment catheter to first collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and then retracting the deployment catheter to draw the closed downstream end of the cylindrical filter body into the delivery sheath.

[0022] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch may include providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the filter body may have an open upstream end, an open downstream end, a radially collapsible support that may be coupled to a periphery of the open downstream end of the filter body, an access port that may be spaced inwardly from each of said ends, a radially constrained delivery configuration, and a radially expanded deployed configuration, and a collapsable nosecone that may be coupled to a upstream end of the cylindrical filter body, advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter may be attached to the cylindrical filter body while the cylindrical filter body remains in its radially constrained configuration to - 6 -SG Docket No.: 14925-720.600position the filter body over the aortic arch, radially expanding the cylindrical filter body so that the porous mesh covers the patient's aortic side vessels, the open upstream end of the cylindrical filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, and the support radially may expand to hold the open downstream end of the filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side vessels, deflating the nosecone after deployment, and advancing a first working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart.

[0023] This and other embodiments may comprise one or more of the following features. In one aspect, the method may further include advancing a second working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart. In another aspect, the method may further include performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter. In yet another aspect, the first working catheter may be introduced through a lumen in the deployment catheter and the second working catheter can be introduced in parallel to the deployment catheter. In still another aspect, the first working catheter may introduce contrast media to an interventional site and the second working catheter can perform an interventional procedure. In an alternative aspect, the interventional procedure may include delivery of a prosthetic aortic valve. In yet another aspect, the deployment catheter may be advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body may include proximally retracting the delivery sheath relative to the deployment catheter. In another aspect, the method may further include retrieving the radially expanded cylindrical filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and draw the closed downstream end of the cylindrical filter body into the delivery sheath. In still another aspect, retracting the deployment catheter to collapse the radially collapsible support may include retracting a tether present in a lumen of the deployment catheter to first collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and then retracting the deployment catheter to draw the closed downstream end of the cylindrical filter body into the delivery sheath.

[0024] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch may comprise providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the filter body may have an open upstream end, an open downstream end, a radially collapsible support may be - 7 -SG Docket No.: 14925-720.600coupled to a periphery of the open downstream end of the filter body, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section at the upstream end of the cylindrical filter body, advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter may be attached to the radially collapsible support on the cylindrical filter body while the cylindrical filter body remains in its radially constrained configuration to position the filter body over the aortic arch, radially expanding the cylindrical filter body so that the porous mesh covers the patient's aortic side vessels, the open upstream end of the cylindrical filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, and the radially collapsible support may radially expand to hold the open downstream end of the filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side vessels, and advancing a first working catheter through the open downstream end of the cylindrical filter body toward the heart.

[0025] This and other embodiments may comprise one or more of the following features. In one aspect, the method may further include advancing a second working catheter through the open downstream end of the cylindrical filter body. In another aspect, the method may further include performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter. In yet another aspect, the first working catheter may be introduced through a lumen in the deployment catheter and the second working catheter may be introduced in parallel to the deployment catheter. In still another aspect, the first working catheter may introduce contrast media to an interventional site and the second working catheter may perform an interventional procedure. In another aspect, the interventional procedure may include delivery of a prosthetic aortic valve. In yet another aspect, the deployment catheter may be advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body may include proximally retracting the delivery sheath relative to the deployment catheter. In still another aspect, the method may further include retrieving the radially expanded cylindrical filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and draw the closed downstream end of the cylindrical filter body into the delivery sheath. In another aspect, retracting the deployment catheter to collapse the radially collapsible support may include retracting a plurality of retraction members present in a lumen of the deployment catheter to first collapse the radially collapsible support to close the open downstream end of the cylindrical filter- 8 -SG Docket No.: 14925-720.600body and then retracting the deployment catheter to draw the closed downstream end of the cylindrical filter body into the delivery sheath.

[0026] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch may comprise providing a filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the filter body may may have an open upstream end, a closed downstream end, a radially collapsible support may be coupled to a periphery of the closed downstream end of the filter body, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section at the upstream end of the filter body, advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter may be attached to the radially collapsible support on the filter body while the filter body remains in its radially constrained configuration to position the filter body over the aortic arch, radially expanding the filter body so that the porous mesh covers the patient's aortic side vessels and the open upstream end of the filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, wherein blood free from emboli flows through the porous mesh into the aortic side vessels, and advancing a first working catheter through an opening at the closed downstream end of the filter body toward the heart.

[0027] This and other embodiments may comprise one or more of the following features. In one aspect, the method may further include advancing a second working catheter through the closed downstream end of the filter body. In yet another aspect, the method may further include performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter. In still another aspect, the first working catheter may be introduced through a lumen in the deployment catheter and the second working catheter may be introduced in parallel to the deployment catheter. In another aspect, the first working catheter may introduce contrast media to an interventional site and the second working catheter may perform an interventional procedure. In yet another aspect, the interventional procedure may include delivery of a prosthetic aortic valve. In an alternative aspect, the deployment catheter may be advanced while present in a delivery sheath which radially constrains the filter body, and wherein radially expanding the filter body may include proximally retracting the delivery sheath relative to the deployment catheter. In still another aspect, the method may further include retrieving the radially expanded filter body by retracting the deployment catheter to collapse the radially collapsible support and draw the closed downstream end of the filter body into the delivery sheath. In a further aspect, retracting the deployment catheter to collapse the radially collapsible support may further include retracting a tether present in a- 9 -SG Docket No.: 14925-720.600lumen of the deployment catheter to first collapse the radially collapsible support and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath.

[0028] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch may include providing a panel formed at least partly from a planar porous mesh, the panel may have a rigid perimeter frame, a closed upstream end, a closed downstream end, a radially collapsible support may be coupled to a periphery of the closed downstream end of the panel, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section may surround the rigid perimeter frame, advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter may be attached to the radially collapsible support on the panel while the panel remains in its radially constrained configuration to position the panel over the aortic arch, radially expanding the panel so that the porous mesh covers the patient's aortic side vessels and the closed upstream end of the panel faces the patient's heart to direct blood flow through the closed upstream end, wherein blood free from emboli flows through the porous mesh into the aortic side vessels, and advancing a first working catheter through an opening at the closed downstream end of the panel toward the heart.

[0029] This and other embodiments may comprise one or more of the following features. In one aspect, the method may further include advancing a second working catheter through the closed downstream end of the panel. In another aspect, the method may further include performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter. In still another aspect, the first working catheter may be introduced through a lumen in the deployment catheter and the second working catheter can be introduced in parallel to the deployment catheter. In yet another aspect, the first working catheter may introduce contrast media to an interventional site and the second working catheter can perform an interventional procedure. In a further aspect, the interventional procedure may include delivery of a prosthetic aortic valve. In yet another aspect, the deployment catheter may be advanced while present in a delivery sheath which radially constrains the panel, and wherein radially expanding the panel may include proximally retracting the delivery sheath relative to the deployment catheter. In still another aspect, the method may further include retrieving the radially expanded panel by retracting the deployment catheter to collapse the radially collapsible support and draw the closed downstream end of the panel into the delivery sheath. In a further aspect, retracting the deployment catheter to collapse the radially collapsible support may include retracting a tether present in a lumen of the deployment catheter to first- 10 -SG Docket No.: 14925-720.600collapse the radially collapsible support and then retracting the deployment catheter to draw the closed downstream end of the panel into the delivery sheath.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0031] FIG. 1 illustrates a top-down view of an embolic protective device according to one embodiment.

[0032] FIG. 2 illustrates a top-down view of an embolic protective device according to another embodiment.

[0033] FIG. 3 illustrates a side view of the embolic protection device of FIG. 1.

[0034] FIG. 4 illustrates a side view of the embolic protection device of FIG. 3 as deployed in an aortic arch.

[0035] FIG. 5 illustrates a side view of the embolic protection device of FIG. 3 as deployed in an aortic arch.

[0036] FIG. 6 illustrates a side view of the embolic protection device of FIG. 3 as deployed in an aortic arch.

[0037] FIG. 7 illustrates a side view of the embolic protection device of FIG. 3 as deployed in an aortic arch.

[0038] FIG. 8 illustrates a side view of the embolic protection device of FIG. 3 as deployed in an aortic arch.

[0039] FIG. 9 shows cross-sectional views FIG. 9A and FIG. 9B of the embolic protection device of FIG. 1 in the aortic arch.

[0040] FIG. 10 illustrates a perspective view of an embolic protective device according to one embodiment.

[0041] FIG. 11 illustrates another embodiment of the embolic protection device of FIG. 10.

[0042] FIG. 12 illustrates a perspective view of an embolic protective device according to another embodiment.

[0043] FIG. 13 illustrates a perspective view of an embolic protective device according to still another embodiment.

[0044] FIG. 14 illustrates another perspective view of the embolic protection device of FIG. 13, with inset view FIG. 14A and inset view FIG. 14B.- 11 -SG Docket No.: 14925-720.600

[0045] FIG. 15 illustrates a further perspective view of the embolic protection device of FIG. 13, with inset view FIG. 15A and inset view FIG. 15B.

[0046] FIG. 16 illustrates a perspective view of an embolic protective device according to another embodiment.

[0047] FIG. 17 illustrates a side view of embolic protection device of FIG. 10 as deployed in an aortic arch.

[0048] FIG. 18 illustrates a side view the embolic protection device of FIG. 12 as deployed in an aortic arch.

[0049] FIG. 19 illustrates a side view the embolic protection device of FIG. 14 as initially deployed in an aortic arch, with the collapsible nosecone inflated.

[0050] FIG. 20 illustrates a side view of the embolic protection device of FIG. 19 in an aortic arch after deflation of the collapsible nosecone.

[0051] FIG. 21 illustrates a top-down view of an embolic protective device according to another embodiment.

[0052] FIG. 22 illustrates a top-down view of an embolic protective device according to still another embodiment.

[0053] FIG. 23 illustrates a side view of both the embolic protection device of FIG. 21 and the embolic protection device of FIG. 20 in an aortic arch.

[0054] FIG. 24 illustrates a further side view of both the embolic protection device of FIG. 21 and the embolic protection device of FIG. 20 in an aortic arch.DETAILED DESCRIPTION

[0055] Briefly, and in general terms, various devices and related methods are directed to an embolic protection device adapted and configured to be more conformable to vessel geometry and / or less traumatic to vessel sidewalls and structures. The embolic protection device, whether embodied as a filter or a deflector, may comprise an extended, conformable distal and / or perimeter section adapted and configured to provide improved sealing in a variety of vessel geometries such as that of the aortic arch. Advantageously, the nosecone may be adapted and configured to transition from a rigid state into a semi-rigid state or be fully collapsible in any stage of the procedure, in order to be less rigid, less traumatic, and more conformable to the aortic wall after device delivery or during performance of a vascular intervention.

[0056] Unlike other embolic protection solutions, embodiments of the embolic protection devices described herein may contain one or more or various combinations of features adapted and configured to make an embolic protection device embodiment (a) more- 12 -SG Docket No.: 14925-720.600conformable to vessel anatomy for improved sealing and (b) less traumatic or reduce likelihood of perforation or damage to vessel sidewall. In various embodiments described herein, there may be 1) an extended, conformable distal or perimeter section to provide improved sealing in a variety of vessel anatomies and 2) a unique dual or multiple mode nosecone that may be designed to transition from a rigid or firm or semi-firm state useful in facilitating vessel access. Thereafter, the nosecone may be collapsible before, during, after or at any stage of the procedure in order to be less rigid, less traumatic and more conformable to the vessel wall. Conformality of the deflated nosecone may be appreciated with reference to FIGS. 14B, 15B, 20, and 24, described below. Put another way, conformality within the context of the present disclosure addresses both the embolic protection device structure and the nosecone modification. The various embodiments of the conformal embolic protection devices described herein may have particular applicability for positioning within the aortic arch, as described further herein.

[0057] In still other embodiments, the reliability of a cylindrical filter for cerebral embolic protection may be improved through the addition of a distal conformable section that more appropriately enhances the ability of the device to create a more complete seal in a variety of aortic anatomies. In one aspect, the conformal portion may be at the distal most end of the embolic protection device or spaced from the distal most end depending on the desired performance improvement of a particular embolic protection device.

[0058] In one aspect, the present disclosure may be an embolic protection device that may be made with a cylindrical surface of fine mesh textile fabric that may be supported on a wire frame or the like. The embolic filter may also consist of a non-woven sheet, such as a thin sheet of polymer or metal or shape memory alloy, that has been perforated with holes of a single size or different sizes. The embolic filter material may be made of a metal, a polymer, or a combination thereof.

[0059] The filter mesh may be held in place across the aortic arch vessels by a wire frame to filter out potential emboli. The outer curve of the device may conform closely to the outer curve of the aortic arch, ideally to conform to the ostia of the cerebral branch vessels. The device may be attached to a handle or cannula for insertion through an aortotomy, or to a catheter for peripheral artery insertion. The attachment to the filter may be only to the frame, only to the filter mesh, or to both the frame and the filter mesh.

[0060] In some embodiments of the embolic protection device, the embolic protection device may comprise a section of conformable material that may extend distally beyond the frame. A conformable material that may extend distally beyond the frame may be appreciated with reference to FIGS. 10-20, described below. In yet another aspect, the conformal material- 13 -SG Docket No.: 14925-720.600or portion may be shaped as “a conformable cuff’, or to have more than one ridge or perimeter, or may be optionally configured as a waist or hourglass profile about the device. The material forming a conformable section may be perforated or porous to allow the passage of blood or may be a solid conformable material. The conformable material may be a continuation of the panel filter mesh or it may be another non-rigid material that may be conformable to maintain contact with the aortic wall after it has been deployed. Further, the conformable material may be a fabric, metal mesh, or polymer. In one embodiment, the conformable material may extend at least 2 mm beyond the rigid frame. In another embodiment, the conformable section may be either flared or of a larger diameter relative to the adjacent section of the filter or portion of an embolic protection device.

[0061] Additional features are described which may be included with the present disclosure. The embolic filter may comprise a mesh made of knitted, woven or nonwoven fibers, filaments, or wires that may have a pore size chosen to allow blood to pass through but prevent emboli above a certain size from passing through. In one embodiment, the pore size may be between 50 and 300 microns. The embolic filter may also consist of some combination of a perforated sheet and a fiber-based mesh. The embolic filter may consist of a single layer or multiple layers of any of the above configurations to increase the filtering efficiency and reduce the effective pore size. Alternatively, the filter may consist of a woven metal or polymer mesh utilizing wires of the same or varying diameters to optimize the pore size.

[0062] The embolic protection device may be delivered in an undeployed or retracted condition via radial, subclavian, femoral, or transcaval access. It may be deployed over a guidewire or without the assistance of a guidewire. The device may be constrained within an outer sheath (delivery sheath) for deployment and may be released by either withdrawing the constraining sheath or advancing the filter out of the sheath. The frame of the device may be made of an elastic or superelastic material so that it can be compressed within the constraining sheath and may expand when the constraint is removed. The material of the frame may be a metal material such as stainless steel, a shape memory alloy such as Nitinol, titanium, an alloy of titanium, MP35N, or it may be a polymeric material such as PEEK, nylon, PTFE, polycarbonate, or polyimide.

[0063] The frame may comprise a stent-like structure, with open cells or closed cells, made from a laser-cut tube, formed wires, or a deposited film. For purposes of this disclosure, the term “wires” also applies to struts of a laser cut frame, regardless of their cross-sectional geometry. The frame may consist of wires in a helical shape or multiple helical shapes, either of the same twist orientation or opposite twist orientations. The wires may freely move with- 14 -SG Docket No.: 14925-720.600respect to each other or may be attached to each other at one or more discrete points to provide additional rigidity or to direct the shape recovery process. The frame may be formed as one continuous structure, or may comprise multiple shorter structures along the length of the filter. In one embodiment, the perimeter frame may be only at the distal (upstream) end of the filter, but may also be connected along the length of the filter to a retraction member at the proximal end of the filter. If it is a multi-cell design, there may be multiple retraction wires connected to the frame that converge to a single point for retraction into the constraining sheath as seen, for example, in the embodiments of FIGS. 10, 11, and 17. As an alternative to a constraining sheath, the embolic protection device may be elongated for delivery with the addition of a separate elongation member attached to the distal end of the embolic protection device that may be withdrawn proximally to force the frame to expand laterally.

[0064] The embolic filter may be in an undeployed or constrained condition as it is inserted into a patient’s aorta. The embolic filter may be deployed in the ascending aorta distal to the ostia of the innominate artery to provide embolic protection of all three cerebral branch vessels of the aortic arch. The embolic filter may be deployed prior to performing another interventional procedure, and retracted or withdrawn with the constraining sheath after the diagnostic or interventional procedure has been completed. Optionally, the embolic filter may include features to assist in retracting the device for retrieval from the patient’s aorta, such as a pull loop or other graspable structure near the downstream end of the embolic filter.

[0065] Further, the entire embolic filter or a portion of it may be coated with an anti- thrombogenic coating, for example, a bonded heparin coating, to reduce the formation of clots that could become potential emboli.

[0066] Further still, the embolic protection device may contain a nosecone to facilitate delivery of the device through the vascular access site and across the aortic arch. The nosecone of an interventional cardiology device may be made from a solid polymer construction, with a central lumen that may accommodate a guidewire, a tapered distal section with a smooth transition to the guidewire at the distal end of the taper, and a similar diameter to the sheath at the proximal end of the taper. The nosecone may present a less traumatic profile as the sheath navigates through the vasculature, to reduce the chances of vascular injury.

[0067] In various embodiments of the present disclosure, the conventional solid nosecone may be replaced with a “collapsible nosecone”, comprising of an inflatable polymer balloon with a distal taper of similar profile to the tapered tip of a conventional nosecone, attached to- 15 -SG Docket No.: 14925-720.600a smaller diameter shaft that may accommodate a guidewire. The shaft may also contain additional lumen(s) to enable inflation and deflation of the balloon. The inflation may occur by the introduction of either fluid or air into the interior of the balloon, and deflation may occur by removal of the same. In a preferred embodiment, inflation may be conducted by introducing a mixture of saline solution and an iodinized contrast solution. The overall construction of the collapsible nosecone and its supporting catheter shaft may be similar to an interventional balloon used for balloon angioplasty; however, in the present disclosure the shape of the balloon itself may be optimized to facilitate its use as a nosecone. Further, the nosecone and / or its supporting member (a semi-rigid member or catheter) may be shaped to direct the nosecone at a certain angle either when inflated or when deflated, or both.

[0068] The collapsible nosecone may be inflated for insertion into the body and for assisting the embolic protection system’s delivery system in tracking across through the vasculature. Once the delivery system is at the deployment location, the collapsible nosecone may be deflated to reduce its rigidity for the rest of the procedure. Deflation of the collapsible nosecone may occur either before or after release of the embolic filter. Further, the nosecone may be reinflated at any time for repositioning, or if desired, for retrieval. Inflation and deflation of the collapsible nosecone may be appreciated with reference to FIGS. 14A, 14B, 15A, 15B, 19, 20, 23, and 24, described below.

[0069] The benefit of a collapsible nosecone on an embolic filter is that it may be deflated to reduce its rigidity after deployment of the filter across the aortic arch. If desired, the collapsible nosecone may then be reinflated after the procedure is finished to facilitate removal of the embolic protection device. With a conventional nosecone, it remains rigid throughout the procedure, creating a localized force on a point on the outer wall of the ascending aorta after deployment and throughout the rest of the interventional procedure (such as TAVR). This, in turn, may produce unnecessary trauma to the aortic wall and may also push the filter away from its initial deployed position.

[0070] An embolic protection device embodiment of the present disclosure may contain a conformable section as described above to provide enhanced wall apposition, a collapsible nosecone as further described above, or both features in some form. Further, the collapsible nosecone of the present disclosure may also be applied to embolic deflecting panels with a conformable perimeter as described in the U.S. Provisional Patent Application 63 / 575,532. Examples of this are shown in FIGS. 1-9 and 21-24 of the present disclosure.

[0071] While embodiments of a collapsible nosecone based on inflatable balloon technology is described herein, variations of the tapered balloon described herein may be replaced with a mechanically expandable frame with a polymer covering, a bladder filled- 16 -SG Docket No.: 14925-720.600with a magnetorheological fluid, or any other expandable and contractable system that allows the rigidity of a nosecone to be made more rigid, adjustably rigid, or to reduce or remove rigidity (i.e., transition into a deflated or most conformable state) after deployment or as needed based on clinical scenario.

[0072] Further, embodiments of the embolic protection device described herein may be an embolic protection deflector device made with a flat or flexible panel of fine mesh textile fabric that may supported on a wire frame or the like. The panel of fine mesh fabric may be held in place over the aortic arch vessels by the wire frame to filter out potential emboli. Being made of fabric, the device may be free to conform to the ostia of the arch vessels. The wire frame may be attached to a handle or cannula for insertion through an aortotomy or to a catheter for peripheral artery insertion. The device may conform closely to the outer curve of the aortic arch so that it will not interfere with performing cardiac surgery or interventional cardiology procedures. The device may contain a section of conformable material outside of the perimeter of the frame. The conformable material may be perforated or porous to allow the passage of blood or may be a solid conformable material. The conformable material may be a continuation of the panel material or another non-rigid material that may be conformable to maintain contact with the aortic wall after it has been deployed. Further, the conformable material may be a fabric, metal mesh, or polymer. In one embodiment, the conformable material may extend at least 2 mm beyond the rigid frame.

[0073] Additional features are described which may be used with the various embodiments of the embolic protection device. The embolic protection device or a portion of it may be coated with an antithrombogenic coating to reduce the formation of clots that could become potential emboli. The embolic filter panel may comprise a mesh made of knitted, woven or nonwoven fibers, filaments or wires that may have a pore size chosen to allow blood to pass through but prevent emboli above a certain size from passing through. In one embodiment, the pore size may be between 50 and 300 microns. The embolic filter may also consist of a non-woven sheet, such as a thin sheet of polymer or metal or shape memory alloy, that has been perforated with holes of a single size or different sizes. The embolic filter material may be made of a metal, a polymer or a combination thereof. The embolic filter may also consist of some combination of a perforated sheet and a fiber-based mesh. The embolic filter may consist of a single layer or multiple layers of any of the above configurations to increase the filtering efficiency and reduce the effective pore size. Alternatively, the filter may consist of a woven metal or polymer mesh utilizing wires of the same or varying diameters to optimize the pore size.- 17 -SG Docket No.: 14925-720.600

[0074] The frame may contain additional features to enable centering within the aortic arch or to provide more stable positioning after deployment. In one embodiment, the wire frame may comprise one or more wire hoops for supporting the embolic protection device within the aortic arch. In another embodiment, the distal end of the frame may contain an elongated distal section that may be angled toward the outer curve of the aortic arch such that it may be inserted into one of the aortic branch vessels (e.g., the innominate artery or the left subclavian) for more stable positioning. In a further embodiment, the distal end of the filter may contain an elongated distal section that may be angled toward the interior of the aorta to create a more atraumatic profile.

[0075] Embodiments of the embolic protection device described herein may be delivered in an undeployed or retracted condition via radial, subclavian, femoral, or transcaval access. It may be deployed over a guidewire or without the assistance of a guidewire. Further, the embolic protection device may be constrained within an outer sheath (delivery sheath) for deployment and may be released by either withdrawing the constraining sheath or advancing the filter out of the sheath. Further still, the frame of the embolic protection device may be made of an elastic or superelastic material, so that it may be compressed within the constraining sheath and may expand when the constraint is removed. Further, the material of the frame may be a metal material such as stainless steel, a shape memory alloy such as Nitinol, titanium, an alloy of titanium, MP35N, or it can be a polymeric material such as PEEK, nylon, PTFE, polycarbonate, or polyimide. As an alternative to a constraining sheath, the embolic protection device may be elongated for delivery with the addition of a separate elongation member attached to the distal end of the device that may be withdrawn proximally to force the frame to expand laterally.

[0076] The various embodiments of an embolic protection device described herein may be maintained in an undeployed or constrained condition as it is inserted into a patient’s aorta. Further, the device may be deployed in the ascending aorta distal to the ostia of the innominate artery to provide embolic protection to all three cerebral branch vessels of the aortic arch. Further still, the embolic protection device may be deployed prior to performing another interventional procedure and retracted or withdrawn with the constraining sheath after the diagnostic or interventional procedure has been completed. Optionally, the embolic protection device or filter may include features to assist in retracting the device for retrieval from the patient’s aorta, such as a pull loop or other graspable structure near the downstream end of the embolic filter.

[0077] In further embodiments of the embolic protection device, the entire embolic protection device, or a portion of it may be coated with an anti-thrombogenic coating, for- 18 -SG Docket No.: 14925-720.600example, a bonded heparin coating, to reduce the formation of clots that could become potential emboli.

[0078] FIG. 1 illustrates a top-down view of an embolic protective device 10 according to one embodiment. As seen in FIG. 1, the embolic protective device 10 may comprise a flat panel deflector 10, a porous mesh panel 20, a frame 30, a delivery sheath 40, a conformable perimeter 50 made from the same material as the porous mesh 20, and a shaped tip 60.

[0079] FIG. 2 illustrates a top-down view of an embolic protective device 10 according to another embodiment. As seen in FIG. 2, the embolic protective device 10 may comprise a flat panel deflector 10, a porous mesh panel 20, a frame 30, a delivery sheath 40, a conformable perimeter 50 made from a different material from the porous mesh 20, such as a polymer membrane, and a shaped tip 60.

[0080] FIG. 3 illustrates a side view of the embolic protection device 10 of FIG. 1. As seen in FIG. 3, the distal tip 60 may be angled toward the outer curve of the aortic arch.

[0081] FIG. 4 illustrates a side view of the embolic protection device 10 of FIG. 3 as deployed in an aortic arch. As seen in FIG. 4, the distal tip 60 may be angled toward the outer curve of the aortic arch and may be situated within the ostium of the innominate artery. Moreover, FIG. 4 further shows the embolic protection device 10 of FIG. 3 as delivered by a femoral access.

[0082] FIG. 5 illustrates a side view of the embolic protection device 10 of FIG. 3 as deployed in an aortic arch. As seen in FIG. 5, the distal tip 60 may be angled toward the middle of the aorta to create a more atraumatic distal tip to the device. Moreover, FIG. 5 further shows the embolic protection device 10 of FIG. 3 as delivered by a femoral access.

[0083] FIG. 6 illustrates a side view of the embolic protection device 10 of FIG. 3 as deployed in an aortic arch. As seen in FIG. 6, the distal tip 60 may be angled toward the outer curve of the aortic arch and may be situated within the ostium of the innominate artery. Moreover, FIG. 6 further shows the embolic protection device 10 of FIG. 3 as delivered by a left radial access.

[0084] FIG. 7 illustrates a side view of the embolic protection device 10 of FIG. 3 as deployed in an aortic arch. As seen in FIG. 7, the distal tip 60 may be angled toward the outer curve of the aortic arch and may be situated within the ostium of the left subclavian artery. Moreover, FIG. 7 further shows the embolic protection device 10 of FIG. 3 as delivered by a right radial access.

[0085] FIG. 8 illustrates a side view of the embolic protection device 10 of FIG. 3 as deployed in an aortic arch. As seen in FIG. 8, the distal tip 60 may be angled toward the outer curve of the aortic arch and may be situated within the ostium of the left subclavian artery.- 19 -SG Docket No.: 14925-720.600Moreover, as seen in FIG. 8, the embolic protection device 10 may comprise a wire hoop 70 for supporting the embolic protection device 10 within the aortic arch. Further, FIG. 8 further shows the embolic protection device 10 of FIG. 3 as delivered by a femoral access.

[0086] FIG. 9 shows cross-sectional views FIG. 9A and FIG. 9B of the embolic protection device 10 of FIG. 1 in the aortic arch. Specifically, FIG. 9 illustrates the ability of the conformable perimeter 50 to maintain wall apposition in both a small aortic diameter shown by FIG. 9 A and a larger aortic diameter shown by FIG. 9B.

[0087] FIG. 10 illustrates a perspective view of an embolic protective device 10 according to one embodiment. As seen FIG. 10, the embolic protection device 10 may comprise a cylindrical filter 12 made from a porous mesh 15, a stent-like wire frame 13, a delivery sheath 40, a conformable distal section 50 made of the same material as the porous mesh, and multiple retraction members 60 that converge to a single point.

[0088] FIG. 11 illustrates another embodiment of the embolic protection device 10 of FIG. 10. As seen in FIG. 11, the embolic protection device 10 may comprise a cylindrical filter 12 made from a porous mesh 15, a stent-like wire frame 13, a delivery sheath 40, a conformable distal section 50 made of a different material from the porous mesh, and multiple retraction members 60 that converge to a single point.

[0089] FIG. 12 illustrates a perspective view of an embolic protective device 10 according to another embodiment. As seen in FIG. 12, the embolic protection device 10 may comprise a cylindrical filter 12 made from a porous mesh 15, a wire frame 13, a delivery sheath 40, and a conformable distal section 50 made of the same material as the porous mesh.

[0090] FIG. 13 illustrates a perspective view of an embolic protective device 10 according to still another embodiment. As seen in FIG. 13, the embolic protection device 10 may comprise a cylindrical filter 12 made from a porous mesh 15, an access port 20, a wire frame 13, a delivery sheath 40, a non-collapsible nosecone 75, and a conformable distal section 50 made of the same material as the porous mesh.

[0091] FIG. 14 illustrates another perspective view of the embolic protection device 10 of FIG. 13, with inset view FIG. 14A and inset view FIG. 14B. As seen in FIG. 14, the embolic protection device 10 may comprise a cylindrical filter 12 made from a porous mesh 15, an access port 20, a wire frame 13, a delivery sheath 40, a collapsible nosecone 70, and a conformable distal section 50 made of the same material as the porous mesh. Further, FIG. 14’s inset FIG. 14A shows the nosecone in its inflated state, while FIG. 14’s inset FIG. 14B shows the nosecone after deflation.

[0092] FIG. 15 illustrates a further perspective view of the embolic protection device 10 of FIG. 13, with inset view FIG. 15 A and inset view FIG. 15B. Specifically, FIG. 15 shows - 20 -SG Docket No.: 14925-720.600an embolic protection device 10 comprising a cylindrical filter 12 made from a porous mesh 15, an access port 20, a wire frame 13, a delivery sheath 40, and a collapsible nosecone 70. Further, FIG. 15’ s inset FIG. 15A illustrates the nosecone in its inflated state, while FIG. 15’ s inset FIG. 15B illustrates the nosecone after deflation.

[0093] FIG. 16 illustrates a perspective view of an embolic protective device 10 according to another embodiment. Specifically, FIG. 16 shows an embolic protection device 10 comprising a cylindrical filter 12 made from a porous mesh 15, a stent-like wire frame comprising multiple sections 13a, 13b, a delivery sheath 40, and a conformable distal section 50 made of the same material as the porous mesh.

[0094] FIG. 17 illustrates a side view of the embolic protection device 10 of FIG. 10 as deployed in an aortic arch. Further, FIG. 17 shows the embolic protection device 10 of Figure 10 as delivered by a femoral access.

[0095] FIG. 18 illustrates a side view the embolic protection device 10 of FIG. 12 as deployed in an aortic arch. Further, FIG. 18 illustrates the embolic protection device 10 of FIG. 12 as delivered by a femoral access.

[0096] FIG. 19 illustrates a side view of the embolic protection device 10 of FIG. 14 as initially deployed in an aortic arch, with the collapsible nosecone 70 inflated. Further, FIG.19 illustrates the embolic protection device 10 of FIG. 14 as delivered by femoral access over a guidewire 46.

[0097] FIG. 20 illustrates a side view of the embolic protection device 10 of FIG. 19 in an aortic arch after deflation of the collapsible nosecone 70. As further seen in FIG. 20, the guidewire 46 has been withdrawn proximally prior to deflation of the nosecone, so it is not shown.

[0098] FIG. 21 illustrates a top-down view of an embolic protective device 10 according to another embodiment. Specifically, FIG. 21 shows the top-down view of the embolic protection device 10 comprising a flat panel deflector 80, a panel 90 made of porous mesh 15, a frame 30, a delivery sheath 40, a conformable perimeter 55 made from the same material as the porous mesh, and a collapsible nosecone 70.

[0099] FIG. 22 illustrates a top-down view of an embolic protective device 10 according to still another embodiment. Further, FIG. 22 illustrates the top-down view of the embolic protection device 10 comprising a flat panel deflector 80, a panel 90 made from a porous mesh 15, a frame 30, a delivery sheath 40, a conformable perimeter 55 made from a different material from the porous mesh, such as a polymer membrane, and a collapsible nosecone 70.

[0100] FIG. 23 illustrates a side view of both the embolic protection device 10 of FIG. 21 and the embolic protection device 10 of FIG. 20 in an aortic arch. Specifically, FIG. 23 shows- 21 -SG Docket No.: 14925-720.600the side view of the embolic protection device 10 of FIG. 21 in an aortic arch, where the collapsible nosecone 70 may be shaped to be angled toward the outer curve of the aortic arch during deployment to assist in positioning by location within the ostium of the innominate artery. Moreover, FIG. 23 further illustrates the embolic protection device 10 of FIG. 20 as delivered by a left radial access over a guidewire 46.

[0101] FIG. 24 illustrates a further side view of both the embolic protection device 10 of FIG. 21 and the embolic protection device 10 of FIG. 20 in an aortic arch. Specifically, FIG. 24 shows a further side view of the embolic protection device 10 of both the embolic protection device of FIG. 21 and the embolic protection device 10 of FIG. 20 in an aortic arch, where the collapsible nosecone 70 has been deflated to minimize trauma to the ostium of the innominate artery. Further, the guidewire 46 has been withdrawn proximally prior to deflation of the nosecone, so it is not shown.

[0102] It is to be appreciated that FIGS. 10, 11, 16, and 17 could be further modified, adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patents 11,707,351, 11,382,734 and U.S. Patent Applications US2021 / 0052375, US2023 / 0070800, US2021 / 0052360, US2022 / 0061976, US2022 / 0226107, and US2023 / 0013559, each one of which is incorporated herein by reference.

[0103] It is to be appreciated that FIGS. 12 and 18 could be further modified, adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S Patents No. 11,071,844, 11717390, 11,717,390, and 8,948,848, U.S. Patent Applications US20140005540, US20160235515, US20210045759, US20240108451, US20210370021, US20120179033, and US20200353208, and PCT Applications WO / 2019 / 173475 Al and WO / 2015 / 061269 Al, each one of which is incorporated herein by reference.

[0104] It is to be appreciated that FIGS. 13-15 and 19-20 could be further modified, adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patent Application US2022 / 0168087 and PCT Application WO / 2020 / 201524A1, each one of which is incorporated herein by reference.

[0105] It is to be appreciated that FIGS. 21-24 could be further modified, adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patent 10,675,139, each one of which is incorporated herein by reference.- 22 -SG Docket No.: 14925-720.600

[0106] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patents 10,881,494, 9,107,734, 8,414,482, 9,770,318, 10,617,507, 10,939,987, 9,492,265, 9,827,085, 10,166,094, 11,051,927, 9,877,821, 10,617,510, 10,617,509, 11,399,927, 11,304,792, 10,610,229, 10,575,852, 8,974,490, 10,512,468, 9,968,359, 9,023,101, 10,433,946, 10,076,400, 11 ,446, 132, 9,579, 182, and 11 ,278,388, U.S. Patent Applications US20170216011, US2017 / 0216011, US2010 / 0312268, US2012 / 0109182, US2015 / 0320540, US2017 / 0360547, US2019 / 0307544, US2021 / 0161638, US2013 / 0178891, US2017 / 0042659, US2018 / 0042390, US2019 / 0183627, US2021 / 0315680, US2015 / 0066075, US2018 / 0110607, US2017 / 0181835, US2023 / 0091397, US2023 / 0210650, US2023 / 0293282, US2020 / 0197151, US2020 / 0253709, and US2004 / 0215167, U.S. Patent Applications 16 / 803,901, 16 / 560,194, 17 / 820,131, 17 / 820,427, 17 / 650,373, 18 / 590,705, and 18 / 522,032, PCT Applications WO / 2004 / 019817, WO / 2008 / 066881A1, WO / 2020 / 168091A1, and WO / 2013 / 103979A1, each one of which is incorporated herein by reference.

[0107] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patents 11,382,733 and 10,702,366, U.S. Patent Applications US2019 / 0000604 Al, US20200297473, and US2021 / 0153999, and PCT Applications WO / 2017 / 042808 Al and WO / 2019 / 224820A1, each one of which is incorporated herein by reference.

[0108] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patents 6,371,935, 6,361,545, 6,254,563, and 6,139,517, each one of which is incorporated herein by reference.

[0109] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patents 6,537,297, 6,499,487, and 5,769,816, each one of which is incorporated herein by reference.

[0110] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patent Application 2003 / 0100940, incorporated herein by reference.[OHl] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the - 23 -SG Docket No.: 14925-720.600embolic protection devices and method(s) of use as described in U.S Patent No. 11,246,698 and U.S. Patent Applications US2017 / 0143356, US2018 / 0368866, US2020 / 0163685, US2022 / 0168086, US2022 / 0331084, and US2022 / 0346932, each one of which is incorporated herein by reference.

[0112] Further, various embodiments and variations of the present disclosure may be adapted and configured for cooperative use, modification or alternative configurations of the embolic protection devices and method(s) of use as described in U.S. Patents 10,500,033, 11,623,068, 10,485,647, 11,000,357, 10,856,961, 11,850,137, 9,668,849, 10,624,732, 8,062,324, and 7,232,453, and U.S. Patent Applications US2022 / 0183814, US2015 / 0039016, US2020 / 0054434, US2021 / 0236258, US2018 / 0177580, US2019 / 0038392, US2016 / 0120636, US2021 / 0085445, US2015 / 0182324, US2016 / 0106531, US2015 / 0257868, US2023 / 0414336, US2018 / 0008392, US2014 / 0336695, US2021 / 0220110, US2014 / 0074152, US2019 / 0076231, US2016 / 0324621, US2020 / 0289251, US2017 / 0224462, US2012 / 0165860, US2011 / 0106137, US2006 / 0293706, US2008 / 0255603, US2007 / 0270901, US2003 / 0171803, US2012 / 0046685, each one of which is incorporated herein by reference.

[0113] Further, Additionally or optionally, the various embodiments of the current disclosure may be advantageously applied to cylindrical devices (both cylindrical deflectors and cylindrical devices with an access port). In still other variations, the conformable perimeter concepts described herein may be applied to improve the conformability of any embolic protection device with a rigid frame.

[0114] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0115] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0116] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present.- 24 -SG Docket No.: 14925-720.600It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0117] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0118] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0119] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed - 25 -SG Docket No.: 14925-720.600below could be termed a first feature / element without departing from the teachings of the present disclosure.

[0120] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0121] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0122] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units- 26 -SG Docket No.: 14925-720.600are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0123] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the disclosure as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the disclosure as it is set forth in the claims.

[0124] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.- 27 -SG Docket No.: 14925-720.600

Claims

CLAIMSWhat is claimed is:

1. An embolic protection device, said device comprising: a filter body comprising a tubular porous mesh material having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said access port comprising an expandable opening configured to conform to at least one working catheter passing therethrough; a radially collapsible support coupled to a periphery of the downstream end of the filter body; a conformable section at the upstream end of the filter body; a catheter body having a distal end coupled to the radially collapsible support; and a delivery sheath having a lumen configured to receive and radially constrain the filter body; wherein the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

2. An embolic protection device as in claim 1, wherein the conformable section comprises a different material from the filter mesh.

3. An embolic protection device as in claim 1, wherein the conformable section comprises the same material as the filter mesh.

4. An embolic protection device as in claim 1, wherein the conformable section has a length between 2mm and 20mm.

5. An embolic protection device as in claim 1, wherein a nosecone is coupled to the upstream end of the filter body.

6. An embolic protection device as in claim 5, wherein the nosecone can be expanded or collapsed.

7. An embolic protection device as in claim 6, wherein the nosecone comprises a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.- 28 -SG Docket No.: 14925-720.6008. An embolic protection device, said device comprising: a filter body comprising a tubular porous mesh material having an open upstream end and an open downstream end; a radially collapsible support coupled to a periphery of the downstream end of the filter body; a conformable section at the upstream end of the filter body; a catheter body having a distal end coupled to the radially collapsible support; and a delivery sheath having a lumen configured to receive and radially constrain the filter body; wherein the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

9. An embolic protection device as in claim 8, wherein the conformable section comprises a different material from the filter mesh.

10. An embolic protection device as in claim 8, wherein the conformable section comprises the same material as the filter mesh.

11. An embolic protection device as in claim 8, wherein the conformable section has a length between 2mm and 20mm.

12. An embolic protection device as in claim 8, wherein a nosecone is coupled to the upstream end of the filter body.

13. An embolic protection device as in claim 12, wherein the nosecone can be expanded or collapsed.

14. An embolic protection device as in claim 13, wherein the nosecone comprises a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

15. An embolic protection device, said device comprising: a filter body comprising a tubular porous mesh material having an open upstream end and a closed downstream end, with an opening at the downstream end to accommodate the introduction of a catheter therethrough;- 29 -SG Docket No.: 14925-720.600a radially collapsible support coupled to a periphery of the downstream end of the filter body; a conformable section at the upstream end of the filter body; a catheter body having a distal end coupled to the radially collapsible support; and a delivery sheath having a lumen configured to receive and radially constrain the filter body; wherein the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.

16. An embolic protection device as in claim 15, wherein the conformable section comprises a different material from the filter mesh.

17. An embolic protection device as in claim 15, wherein the conformable section comprises the same material as the filter mesh.

18. An embolic protection device as in claim 15, wherein the conformable section has a length between 2mm and 20mm.

19. An embolic protection device as in claim 15, wherein a nosecone is coupled to the upstream end of the filter body.

20. An embolic protection device as in claim 19, wherein the nosecone can be expanded or collapsed.

21. An embolic protection device as in claim 20, wherein the nosecone comprises a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

22. An embolic protection device, said device comprising: a panel made from a planar porous mesh material with a rigid perimeter frame, a closed upstream end, and a closed downstream end; a radially collapsible support coupled to a periphery of the downstream end of the panel; a conformable section surrounding the perimeter frame; a catheter body having a distal end coupled to the radially collapsible support; and- 30 -SG Docket No.: 14925-720.600a delivery sheath having a lumen configured to receive and radially constrain the panel; wherein the catheter body may be distally advanced relative to the delivery sheath to release the panel from constraint and to allow the panel to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the panel back into the lumen of the delivery sheath.

23. An embolic protection device as in claim 22, wherein the conformable section comprises a different material from the filter mesh.

24. An embolic protection device as in claim 22, wherein the conformable section comprises the same material as the filter mesh.

25. An embolic protection device as in claim 22, wherein the conformable section has a length between 2mm and 20mm.

26. An embolic protection device as in claim 22, wherein a nosecone is coupled to the upstream end of the panel.

27. An embolic protection device as in claim 26, wherein the nosecone can be expanded or collapsed.

28. An embolic protection device as in claim 27, wherein the nosecone comprises a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

29. An embolic protection device, said device comprising: a filter body comprising a tubular porous mesh material having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said access port comprising an expandable opening configured to conform to at least one working catheter passing therethrough; wherein a nosecone is coupled to the upstream end of the filter body; wherein a delivery sheath having a lumen configured to receive and radially constrain the filter body; wherein the catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter body to radially expand and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the filter body back into the lumen of the delivery sheath.- 31 -SG Docket No.: 14925-720.60030. An embolic protection device as in claim 29, wherein the nosecone can be expanded or collapsed.

31. An embolic protection device as in claim 30, wherein the nosecone comprises a polymer balloon that can be inflated via the introduction of fluid or air, and deflated via the removal of fluid or air.

32. A method for advancing a working catheter over a patient's aortic arch, said method comprising: providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the cylindrical filter body having an open upstream end, an open downstream end, an access port spaced inwardly from each of said ends, a radially collapsible support coupled to a periphery of the open downstream end of the cylindrical filter body, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section at the upstream end of the cylindrical filter body; advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter is attached to the radially collapsible support on the cylindrical filter body while the cylindrical filter body remains in its radially constrained configuration to position the cylindrical filter body over the aortic arch; radially expanding the cylindrical filter body so that the porous mesh covers the patient's aortic side vessels, the upstream end of the cylindrical filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, and the radially collapsible support radially expands to hold the open downstream end of the cylindrical filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side vessels; and advancing a first working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart.

33. A method as in claim 32, further comprising advancing a second working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart.- 32 -SG Docket No.: 14925-720.60034. A method as in claim 33, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter.

35. A method as in claim 34, wherein the first working catheter is introduced through a lumen in the deployment catheter and the second working catheter is introduced in parallel to the deployment catheter.

36. A method as in claim 34, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

37. A method as in claim 34, wherein the interventional procedure comprises delivery of a prosthetic aortic valve.

38. A method as in claim 33, wherein the deployment catheter is advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body comprises proximally retracting the delivery sheath relative to the deployment catheter.

39. A method as in claim 38, further comprising retrieving the radially expanded cylindrical filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and draw the closed downstream end of the cylindrical filter body into the delivery sheath.

40. A method as in claim 39, wherein retracting the deployment catheter to collapse the radially collapsible support comprises retracting a tether present in a lumen of the deployment catheter to first collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and then retracting the deployment catheter to draw the closed downstream end of the cylindrical filter body into the delivery sheath.

41. A method for advancing a working catheter over a patient's aortic arch, said method comprising: providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the filter body having an open upstream end, an open downstream end, a radially collapsible support coupled to a periphery of the open downstream end of the filter body, an access port spaced inwardly from each of said ends, a radially constrained delivery configuration, and- 33 -SG Docket No.: 14925-720.600a radially expanded deployed configuration, and a collapsible nosecone coupled to a upstream end of the cylindrical filter body; advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter is attached to the cylindrical filter body while the cylindrical filter body remains in its radially constrained configuration to position the filter body over the aortic arch; radially expanding the cylindrical filter body so that the porous mesh covers the patient's aortic side vessels, the open upstream end of the cylindrical filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, and the support radially expands to hold the open downstream end of the filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side vessels; deflating the nosecone after deployment; and advancing a first working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart.

42. A method as in claim 40, further comprising advancing a second working catheter through the open downstream end of the cylindrical filter body and through the access port toward the heart.

43. A method as in claim 41, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter.

44. A method as in claim 42, wherein the first working catheter is introduced through a lumen in the deployment catheter and the second working catheter is introduced in parallel to the deployment catheter.

45. A method as in claim 42, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

46. A method as in claim 42, wherein the interventional procedure comprises delivery of a prosthetic aortic valve.

47. A method as in claim 41, wherein the deployment catheter is advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein- 34 -SG Docket No.: 14925-720.600radially expanding the cylindrical filter body comprises proximally retracting the delivery sheath relative to the deployment catheter.

48. A method as in claim 46, further comprising retrieving the radially expanded cylindrical filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and draw the closed downstream end of the cylindrical filter body into the delivery sheath.

49. A method as in claim 47, wherein retracting the deployment catheter to collapse the radially collapsible support comprises retracting a tether present in a lumen of the deployment catheter to first collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and then retracting the deployment catheter to draw the closed downstream end of the cylindrical filter body into the delivery sheath.

50. A method for advancing a working catheter over a patient's aortic arch, said method comprising: providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the filter body having an open upstream end, an open downstream end, a radially collapsible support coupled to a periphery of the open downstream end of the filter body, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section at the upstream end of the cylindrical filter body; advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter is attached to the radially collapsible support on the cylindrical filter body while the cylindrical filter body remains in its radially constrained configuration to position the filter body over the aortic arch; radially expanding the cylindrical filter body so that the porous mesh covers the patient's aortic side vessels, the open upstream end of the cylindrical filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, and the radially collapsible support radially expands to hold the open downstream end of the filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side vessels; and advancing a first working catheter through the open downstream end of the cylindrical filter body toward the heart.- 35 -SG Docket No.: 14925-720.60051. A method as in claim 50, further comprising advancing a second working catheter through the open downstream end of the cylindrical filter body.

52. A method as in claim 51, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter.

53. A method as in claim 52, wherein the first working catheter is introduced through a lumen in the deployment catheter and the second working catheter is introduced in parallel to the deployment catheter.

54. A method as in claim 52, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

55. A method as in claim 52, wherein the interventional procedure comprises delivery of a prosthetic aortic valve.

56. A method as in claim 51, wherein the deployment catheter is advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body comprises proximally retracting the delivery sheath relative to the deployment catheter.

57. A method as in claim 56, further comprising retrieving the radially expanded cylindrical filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and draw the closed downstream end of the cylindrical filter body into the delivery sheath.

58. A method as in claim 57, wherein retracting the deployment catheter to collapse the radially collapsible support comprises retracting a plurality of retraction members present in a lumen of the deployment catheter to first collapse the radially collapsible support to close the open downstream end of the cylindrical filter body and then retracting the deployment catheter to draw the closed downstream end of the cylindrical filter body into the delivery sheath.

59. A method for advancing a working catheter over a patient's aortic arch, said method comprising:- 36 -SG Docket No.: 14925-720.600providing a filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, the filter body having an open upstream end, a closed downstream end, a radially collapsible support coupled to a periphery of the closed downstream end of the filter body, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section at the upstream end of the filter body; advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter is attached to the radially collapsible support on the filter body while the filter body remains in its radially constrained configuration to position the filter body over the aortic arch; radially expanding the filter body so that the porous mesh covers the patient's aortic side vessels and the open upstream end of the filter body faces the patient's heart to direct blood flow through the open upstream end and emboli into the collection chamber, wherein blood free from emboli flows through the porous mesh into the aortic side vessels; and advancing a first working catheter through an opening at the closed downstream end of the filter body toward the heart.

60. A method as in claim 59, further comprising advancing a second working catheter through the closed downstream end of the filter body.

61. A method as in claim 60, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter.

62. A method as in claim 61, wherein the first working catheter is introduced through a lumen in the deployment catheter and the second working catheter is introduced in parallel to the deployment catheter.

63. A method as in claim 61, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

64. A method as in claim 61, wherein the interventional procedure comprises delivery of a prosthetic aortic valve.- 37 -SG Docket No.: 14925-720.60065. A method as in claim 60, wherein the deployment catheter is advanced while present in a delivery sheath which radially constrains the filter body, and wherein radially expanding the filter body comprises proximally retracting the delivery sheath relative to the deployment catheter.

66. A method as in claim 65, further comprising retrieving the radially expanded filter body by retracting the deployment catheter to collapse the radially collapsible support and draw the closed downstream end of the filter body into the delivery sheath.

67. A method as in claim 66, wherein retracting the deployment catheter to collapse the radially collapsible support comprises retracting a tether present in a lumen of the deployment catheter to first collapse the radially collapsible support and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath.

68. A method for advancing a working catheter over a patient's aortic arch, said method comprising: providing a panel formed at least partly from a planar porous mesh, the panel having a rigid perimeter frame, a closed upstream end, a closed downstream end, a radially collapsible support coupled to a periphery of the closed downstream end of the panel, a radially constrained delivery configuration, a radially expanded deployed configuration, and a conformable section surrounding the rigid perimeter frame; advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter is attached to the radially collapsible support on the panel while the panel remains in its radially constrained configuration to position the panel over the aortic arch; radially expanding the panel so that the porous mesh covers the patient's aortic side vessels and the closed upstream end of the panel faces the patient's heart to direct blood flow through the closed upstream end, wherein blood free from emboli flows through the porous mesh into the aortic side vessels; and advancing a first working catheter through an opening at the closed downstream end of the panel toward the heart.

69. A method as in claim 68, further comprising advancing a second working catheter through the closed downstream end of the panel.- 38 -SG Docket No.: 14925-720.60070. A method as in claim 69, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second catheter.

71. A method as in claim 70, wherein the first working catheter is introduced through a lumen in the deployment catheter and the second working catheter is introduced in parallel to the deployment catheter.

72. A method as in claim 70, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

73. A method as in claim 70, wherein the interventional procedure comprises delivery of a prosthetic aortic valve.

74. A method as in claim 69, wherein the deployment catheter is advanced while present in a delivery sheath which radially constrains the panel, and wherein radially expanding the panel comprises proximally retracting the delivery sheath relative to the deployment catheter.

75. A method as in claim 74, further comprising retrieving the radially expanded panel by retracting the deployment catheter to collapse the radially collapsible support and draw the closed downstream end of the panel into the delivery sheath.

76. A method as in claim 75, wherein retracting the deployment catheter to collapse the radially collapsible support comprises retracting a tether present in a lumen of the deployment catheter to first collapse the radially collapsible support and then retracting the deployment catheter to draw the closed downstream end of the panel into the delivery sheath.- 39 -SG Docket No.: 14925-720.600

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