Embolic protection device, system, and methods of delivery thereof

Abstract

An embolic protection device comprising a filter body comprising a tubular porous mesh material having an outer layer and an inner layer with an open upstream end, an open downstream end, a radially collapsible support coupled to a periphery of the downstream end of the filter body. There is 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

EMBOLIC PROTECTION DEVICE, SYSTEM, AND METHODS OF DELIVERY THEREOFCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 694,162, filed September 12, 2024, titled “EMBOLIC PROTECTION DEVICE, SYSTEM, AND METHODS OF DELIVERY THEREOF,” which is herein incorporated by reference in its 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 invention relates generally to medical devices and methods and more particularly to apparatus and methods for providing embolic protection to a patient's aortic arch vessels during cardiac surgery and interventional cardiology procedures.

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

[0005] Of particular interest to the present invention, a number of procedures are performed on aortic valves using catheters advanced over the patient's aortic arch. Valvuloplasty procedures have been performed for many years and use high pressure balloons advanced over the aortic arch to disrupt calcifications on the aortic valve. Such procedures present a significant risk of emboli release to the cerebral arteries. More recently, percutaneous aortic valve replacement (PAVR) procedures, also known as transcatheter aortic valve implantation (TAVI) procedures or transcatheter aortic valve replacement (TAVR) procedures, have been approved, and their use has become widespread. While- 1 -SG Docket No. 14925-719.600offering many patient benefits, they also present a significant risk of emboli release, particularly when performed transvascularly with catheters introduced over the aortic arch.

[0006] The prevention of embolism in these and other procedures would benefit patients and improve the outcome of many surgical procedures. Given that potential emboli are often dislodged during catheter-based procedures that involve more than one access site and more than one procedural device, it would be advantageous to deploy an embolic protection system that provides multiple access paths through or beyond the protection device to perform diagnostic and interventional procedures with multiple catheters. It would be further advantageous to integrate the embolic protection system on a sheath that is being used to perform the procedure, such as is used with an angiographic diagnostic catheter, a transcatheter valve delivery system, and an electrophysiology catheter.

[0007] U.S. Patent Publ. No. 2015 / 0066075, commonly assigned herewith, describes an introducer sheath, intended specifically for use in valvuloplasty and TAVR procedure, which addresses some of the shortcomings of prior embolic protection sheath access devices. The '075 sheath includes embolic protection elements and is suitable for advancing a contrast or other small catheter through the sheath and a second catheter through port formed in a filter. While a significant improvement over previous embolic protection access sheathes having features, particular designs of the '075 access can be challenging to deploy and retrieve, can lose small amounts of emboli, and can have a relatively large profile during deployment.

[0008] U.S. Patent Publ. No. 2023 / 0091397 commonly assigned herewith, describes a multi-access intraprocedural embolic protection device, that may be advantageously used in valvuloplasty and TAVR procedures, which also addresses some of the shortcomings of prior embolic protection devices. The '397 device includes double wall embolic protection filter designs that may be used to form a wide range of internal elements including a port suitable for advancing a contrast or other small catheter as well as a second catheter through port formed in a filter. While the ‘397 devices provide a significant improvement over previous embolic protection devices, there remains a need for additional embolic filter designs with more flexibility in the arrangement of the one or more layers of an embolic protection device, for example, to specifically adapt for improved strength or one or more layers used to form specific interior features.

[0009] Therefore, it would be desirable to provide improved devices, systems, and methods for preventing embolism during cardiac and other procedures performed over the aortic arch. Such devices, systems, and methods should offer less complicated deployment protocols, should have a relatively low profile when being deployed, and should afford- 2 -SG Docket No. 14925-719.600reliable and efficient emboli containment at all times during a procedure. At least some of these objectives will be met by the inventions described herein.SUMMARY OF THE DISCLOSURE

[0010] The present invention provides methods, systems, and devices for collecting emboli and in particular for preventing the release of emboli into the cerebral vasculature during the performance of interventional procedures in a patient's aorta, including aortic valve replacement, aortic valve valvuloplasty, and the like, where there is a risk of emboli being released into the aortic side vessels, including the brachiocephalic artery, the left carotid artery, and the left subclavian artery. The present invention provides embolic protection devices, tubular filter bodies, and systems and methods for placement of the devices and filters through the descending aorta and over the aortic arch to inhibit emboli release into the aortic side branch vessels while allowing simultaneous access to the aortic valve by one, two, three or more interventional and / or diagnostic catheters being introduced from the descending aorta, typically by conventional unilateral or bilateral femoral artery access.

[0011] The embolic protection devices include a filter body and a deployment catheter body connected to the filter body. The filter body typically comprises a tubular porous mesh material and has an open upstream end to allow the entry of blood flow and emboli and an open downstream end to allow entry of at least one working catheter and usually two or more working catheters simultaneously. For the purposes of this invention, the terms “tubular”, “cylindrical” and “conical” can be considered to be equivalents, as they all describe a device or portion of a device with a roughly circular or oval cross-section and a non-negligible length. The deployment catheter body is directly or indirectly coupled to the open downstream end of the filter body, where upstream and downstream refer to the direction of blood flow, e.g. downstream is toward the descending aorta and away from the heart and aortic arch. At least one access port or passage is provided in an interior of the filter body, and the deployment catheter body may have at least one lumen to provide at least one access route to an interior of the tubular filter body for introducing a diagnostic, interventional or other working catheter through the access port. Preferably, the access port may be selfsealing or otherwise expand or conform to accept a diagnostic, interventional or other working catheter therethrough. Preferably, one or more additional working catheters may be introduced through the same access port simultaneously or sequentially with a first catheter introduced through the sheath. Additional catheter-access ports could be included to provide other, parallel access routes through the filter body but are not usually necessary as the access- 3 -SG Docket No. 14925-719.600port will typically have a diameter which is sufficiently expandable to allow the simultaneous passage of two or more catheters while being partly or completely closed to block emboli release when no catheter is present. Other axially aligned catheter-access ports could also be included to provide additional emboli capture chambers within the filter body.

[0012] In a first specific aspect of the present invention, an embolic protection device comprises a filter body formed from a tubular porous mesh material and having an open upstream end and an open downstream end. An access port is spaced inwardly from each of the ends, and the access port includes an expandable opening configured to conform to at least one working catheter passing therethrough. A radially collapsible support is coupled to a periphery of the downstream end of the filter body, and a catheter body having a distal end is coupled to the radially collapsible support, where distal refers to a direction on the device away from the operator, i.e., further away from the portion of the device that is outside the body. Similarly, the term proximal refers to a direction of the device closer to the operator, i.e., nearer to the portion of the device that is outside the body. A delivery sheath has a lumen configured to receive and radially constrain the filter body such that 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 with the support circumscribing the downstream end of the filter body. In this way, the catheter body may be distally advanced and proximally retracted relative to the delivery sheath to move the assembly of the support and filter body out of and into the lumen of the delivery sheath. In particular, when advanced out of the delivery sheath, the support will open to assist in deployment of the downstream end of the filter body and, when retracted back into the delivery sheath, the support will close to collapse the downstream end of the filter body prior to the filter body being drawn into the lumen.

[0013] In particular embodiments, the filter body has an open cylindrical chamber disposed between a downstream end of the port and the downstream end of the filter body. The port may comprise a wall portion of the tubular porous mesh material, wherein the wall portion folds, inverts, or otherwise deflects radially inwardly as other wall portions expand when released from radial constraint from the delivery sheath. In still other particular embodiments, the port may be defined by a wall portion that is constricted, pinched, or otherwise closed radially inwardly but will open in response to the passage of the working catheter(s) therethrough. In an alternative embodiment, the wall portion everts to form a port having a conical opening or base on a downstream side. For example, the everted wall portion of the tubular porous mesh material may have a resiliently closed sleeve portion extending in an upstream direction from an apex of the conical opening or base which defines - 4 -SG Docket No. 14925-719.600the opening of the port. In another alternative embodiment, there may be more than one port along the length of the filter body.

[0014] In still further particular embodiments, the radially collapsible support may comprise a loop secured around the periphery of the downstream end of the filter body. The loop may be connected to a tether which passes through a deployment lumen in the catheter body. The loop may be configured as a lasso to allow the tether to draw the open end of the filter body closed prior to drawing the filter body into the lumen of the delivery sheath. Alternatively, the radially collapsible support may comprise a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.

[0015] In still other particular embodiments of the present invention, the catheter body will include a lumen for receiving at least one working catheter so that the working catheter may be advanced through the lumen and into the open downstream end of the filter body and then through the port. The catheter body may further include at least one additional lumen for receiving a tether attached to the radially collapsible support. Additional lumens may also be provided for other purposes.

[0016] In a second specific aspect of the present invention, a luminal emboli capture device comprises a filter body formed from a tubular porous mesh material and having an open upstream end, an open downstream end, and at least a first port spaced inwardly from each of the ends. The port comprises an opening configured to conform to at least one working catheter passing therethrough, and the filter body will have at least an open cylindrical chamber at its downstream end and an open cylindrical chamber at its upstream end, where the port is disposed therebetween. The emboli capture device may further comprise a catheter body having a distal end coupled to the downstream end of the filter body.

[0017] In specific embodiments, the porous mesh material comprises a fabric of knitted, braided, woven, or nonwoven fibers, filaments, or wires having a pore size chosen to prevent emboli over a predetermined size from passing therethrough. In many embodiments, the fabric will be double-walled over at least a portion of the tubular mesh, and the porous mesh material may be made of a resilient metal, a polymer material, a malleable material, a plastically deformable material, a shape-memory material, or combinations thereof. In further specific cases, the porous mesh material may have an anti-thrombogenic coating on its surface, and the pore size will typically be in the range from about 1 mm to about 0.05 mm.

[0018] An exemplary porous mesh material comprises a Nitinol (nickel -titanium alloy) braid formed from 288 individual wires, each wire being at least 0.001 inch in diameter,- 5 -SG Docket No. 14925-719.600formed to a final double-layer mesh diameter of between 20 mm and 40 mm. In a further specific embodiment, the braid may comprise more than one wire size, with each wire of a diameter between 0.001 and 0.005 inches. An exemplary braid of this embodiment comprises a double layer Nitinol (nickel -titanium alloy) braid formed from 288 individual wires with three different wire sizes between 0.002 and 0.0035 inches in diameter, with each wire size comprising no fewer than 36 wires and no more than 144 wires of the total 288-wire braid. In a further specific embodiment, the mesh may initially comprise a braid made in a “1 under 1 over 1” braiding pattern, a “1 under 2 over 2” braiding pattern, or a “2 under 2 over 2” braiding pattern, with a braid angle between 40° and 70°.

[0019] In further particular embodiments, the at least first port is formed from or comprises a wall portion of the tubular porous mesh material. The wall portion is formed or shaped, e.g. being thermally shaped and set, so that the port folds or closes radially inwardly as other wall portions expand when released from constraint. In a specific embodiment, the porous mesh material is made from a shape memory alloy such as Nitinol and the thermal shape setting of the mesh is performed at a temperature between 450° and 575°C in an air furnace, a belt furnace, a vacuum furnace, a controlled-environment furnace, a fluidized bed, or a molten salt bath. In a further specific embodiment, the interior of the braid is constrained on a cylindrical metal mandrel, with clamps, wires or mating curved mandrels on the outside to constrain the braid to the desired shape during the heat treatment.

[0020] In another particular embodiment, the filter body may comprise two or more layers after forming. In a specific embodiment in which the filter body comprises two layers of porous mesh, the port is formed from only the inner layer, while the outer layer remains cylindrical through the portion of the filter radially surrounding the port. Preferably the entire filter is formed from one continuous porous mesh material to avoid joints, simplify manufacturing and reduce profile. In a particular embodiment, the filter is formed in a first step by everting the porous mesh material over itself to form a double-wall structure prior to forming the port in one or more subsequent steps. More than two layers can be formed in the filter by additional eversion steps, in which case the port can comprise one or more inner layers while one or more outer layers can remain cylindrical through the portion of the filter radially surrounding the port.

[0021] Preferably, the port may be defined by a wall portion of the tubular porous mesh which is constricted, pinched, or otherwise closed radially inwardly but will open in response to the passage of the working catheter(s) therethrough. In alternate embodiments, the upstream end of the port may extend upstream of a portion of the wall from which it is formed to create a conical shape with its base on the downstream side. In a further alternative - 6 -SG Docket No. 14925-719.600embodiment, the wall portion may be pre-shaped to invert to form a port with a conical opening on a downstream side, and a closed sleeve portion extending in an upstream direction from an apex of the conical opening which defines an expandable opening of the port. In further embodiments, the port may be located along the central axis of the filter body, or it may be offset toward one wall. In a particular embodiment, in addition to the upstream and downstream chambers, the filter body may have one or more open “central” cylindrical chambers between a downstream end of the first or other port and an upstream end of the second or other port.

[0022] In a third specific aspect, the present invention provides a method for advancing a working catheter into and / or over a patient's aortic arch. A cylindrical filter body formed at least partly from a porous mesh is provided. The cylindrical filter body defines a collection chamber for emboli and has an open upstream end, an open downstream end, an access port spaced inwardly from each of the ends, and a radially collapsible support coupled to a periphery of the downstream end of the filter body. A deployment catheter which carries and constrains the cylindrical filter body is advanced to a downstream side of the aortic arch while the filter body remains in its radially constrained configuration, typically with a previously placed delivery sheath. The cylindrical filter body is radially expanded so that a wall of the porous mesh covers the patient's aortic side or branch vessels, and the open upstream end of the filter body faces the patient's heart. Blood flows into an interior of the filter body through the open upstream end, and emboli collect in the collection chamber. As the filter body is deployed, the support radially expands to hold the downstream end of the filter body open, and blood flowing through the porous mesh of the filter body and into the aortic side vessels is substantially emboli free. After the filter body is deployed, a first working catheter can be advanced through the open downstream end of the filter body and through the access port and toward the heart. Optionally, a second working catheter may be advanced through the open downstream end of the filter body and through the access port toward the heart, either simultaneously or sequentially with placement of the first working catheter.

[0023] In particular embodiments, a first diagnostic or interventional procedure may be performed with the first working catheter and a second diagnostic or interventional procedure may be performed with the second catheter. It will be appreciated that third, fourth, and additional working catheters may also be introduced and advanced either simultaneously or sequentially with other working catheters.

[0024] The first working catheter is typically introduced through a lumen in the deployment catheter, and the second working catheter may be introduced in parallel to the - 7 -SG Docket No. 14925-719.600deployment catheter. In this way, the delivery profile of the deployment catheter can be minimized. In one example, a first working catheter will be used to introduce contrast media to an interventional site while a second working catheter will perform an interventional procedure at that site. More specifically, the interventional procedure may comprise delivery of a prosthetic aortic valve, performance of valvuloplasty, or the like.

[0025] In still further particular embodiments, the deployment catheter is advanced while present in a delivery sheath which radially constrains the cylindrical filter body. Radially expanding the cylindrical filter body may comprise proximally retracting the delivery sheath relative to the deployment catheter. Typically, the radially expanded filter body is retrieved by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the filter and draw the closed downstream end of the filter body into the delivery sheath. More specifically, retracting the deployment catheter to collapse the radially collapsible support may comprise retracting a tether present in the lumen of the deployment catheter to first collapse the radially collapsible support to close the downstream end of the filter body and then to retract the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath.

[0026] In still further embodiments, the filter may contain one or more support structures or wires that provide longitudinal and / or radial stiffness to the device to prevent compression or movement of the filter during the procedure. Such wires or structures may extend the full length of the device or only for a portion of its length and such wires or structures shall be either fixedly or slidably attached to the access sheath. Such support structures may be stent like, or may consist of curved or helical wires. Further, there may be such support structures for the entire length, at the downstream end, in the middle, at the upstream end, or some combination thereof.

[0027] In general, in one embodiment, an embolic protection device includes a filter body, a radially collapsible support, a catheter body and a delivery sheath. The filter body comprises a tubular porous mesh material having an inner layer and an outer layer, the filter body having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said port comprising an expandable opening configured to conform to at least one working catheter passing therethrough, wherein the port is formed from only an inner layer of the filter body. The radially collapsible support is coupled to a periphery of the open downstream end of the filter body. The catheter body has a distal end coupled to the radially collapsible support. The delivery sheath has a lumen configured to receive and radially constrain the filter body. The catheter body may be distally advanced relative to the delivery sheath to release the filter body from constraint and to allow the filter- 8 -SG Docket No. 14925-719.600body to radially expand with the radially collapsible support circumscribing the open downstream end of the filter body and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the radially collapsible support and filter body back into the lumen of the delivery sheath such that the radially collapsible support radially collapses the open downstream end of the filter body prior to the filter body being drawn into the lumen.

[0028] This and other embodiments can include one or more of the following features. In one aspect, the tubular porous mesh material of the filter body can be formed from one continuous mesh. In another aspect, the filter body can have an open cylindrical chamber between a downstream end of the port and the downstream end of the filter body. In a further aspect, the filter body can have an open cylindrical chamber between an upstream end of the port and the upstream end of the filter body. In another aspect, the port can include a portion of the inner layer of the tubular porous mesh material which folds or closes radially inwardly as filter body expands when released from radial constraint from the delivery sheath. In yet another aspect, the wall portion of the inner layer can be radially inwardly collapsed to define the expandable opening of the port. In another aspect, the port can have a downstream conical portion with its apex in the upstream direction. In another aspect, the port can have an upstream conical portion with its apex in the downstream direction. In yet another aspect, the port can have both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction. In an alternative aspect, the port can have a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber. In another aspect, the port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port can project upstream of the bottom of the open cylindrical chamber. In yet another aspect, the port can be located closer to the outer layer of the tubular porous mesh and off-center from a central longitudinal axis of the filter body. In a further aspect, the radially collapsible support can include a loop secured around the periphery of the downstream end of the filter body. In yet another aspect, the catheter body can have at least one deployment lumen which receives a tether attached to the loop. In yet another aspect, the loop can be configured as a lasso to allow the tether to draw the open end of the filter body closed prior to drawing the filter body into the lumen of the delivery sheath. In yet another aspect, the radially collapsible support can include a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body. In still another aspect, the catheter body can include at least a working catheter lumen for advancing- 9 -SG Docket No. 14925-719.600a working catheter therethrough, into the open downstream end of the filter body, and through the port.

[0029] In general, in one embodiment, an embolic protection device includes a filter body, a radially collapsible support, a catheter body and a delivery sheath. The filter body includes a tubular porous mesh material having an inner layer and an outer layer, the filter body having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said port includes an expandable opening configured to conform to at least one working catheter passing therethrough, wherein the filter body has an open cylindrical chamber between a downstream end of the access port and the downstream end of the filter body or the filter body has an open cylindrical chamber between an upstream end of the access port and the upstream end of the filter body further wherein the open cylindrical chamber is formed only by the outer layer of the filter body. The radially collapsible support is coupled to a periphery of the open downstream end of the filter body. The catheter body has a distal end coupled to the radially collapsible support. The delivery sheath has 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 with the radially collapsible support circumscribing the open downstream end of the filter body and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the radially collapsible support and filter body back into the lumen of the delivery sheath such that the radially collapsible support radially collapses the open downstream end of the filter body prior to the filter body being drawn into the lumen.

[0030] This and other embodiments can include one or more of the following features. In one aspect, the tubular porous mesh material of the filter body can be formed from one continuous mesh. In another aspect, the port can include a portion of the inner layer of the tubular porous mesh material which folds or closes radially inwardly as filter body expands when released from radial constraint from the delivery sheath. In yet another aspect, the wall portion of the inner layer can be radially inwardly collapsed to define the expandable opening of the port. In a further aspect, the port can have a downstream conical portion with its apex in the upstream direction. In still another aspect, the port can have an upstream conical portion with its apex in the downstream direction. In another aspect, the port can have both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction. In an alternative aspect, the port can have a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber. In still- 10 -SG Docket No. 14925-719.600another aspect, the port can be located closer to the outer layer of the tubular porous mesh and off-center from a central longitudinal axis of the filter body. In another aspect, the radially collapsible support can include a loop secured around the periphery of the downstream end of the filter body. In yet another aspect, the catheter body can have at least one deployment lumen which receives a tether attached to the loop. In still another aspect, the loop can be configured as a lasso to allow the tether to draw the open end of the filter body closed prior to drawing the filter body into the lumen of the delivery sheath. In another aspect, the radially collapsible support can include a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body. In yet another aspect, the catheter body can include at least a working catheter lumen for advancing a working catheter therethrough, into the open downstream end of the filter body, and through the port.

[0031] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch includes providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, advancing a deployment catheter into the patient’s aortic arch, radially expanding the cylindrical filter body so a portion of the porous mesh covers one or more of the aortic side vessels of the patient’s aortic arch, with the upstream end of the cylindrical filter body towards the patient's heart to direct blood flow through the upstream end of the cylindrical filter body and emboli into the collection chamber, while the radially collapsible support radially expands holding the downstream end of the cylindrical filter body open, wherein blood free from emboli flows through the porous mesh into the one or more of the aortic side vessels of the patient’s aortic arch, and advancing a first working catheter through the open downstream end of the filter body and through the access port toward the heart. The cylindrical filter body has an open upstream end, an open downstream end, an access port formed only from an inner layer of the porous mesh, the access port spaced inwardly from each of the open upstream end and the open downstream end, a radially collapsible support coupled to a periphery of the downstream end of the filter body, the cylindrical filter body having a radially constrained delivery configuration, and a radially expanded deployed configuration. The 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 delivery configuration to position the filter body over the aortic arch.

[0032] This and other embodiments can include one or more of the following features. In one aspect, the method can further include advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart. In- 11 -SG Docket No. 14925-719.600another aspect, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second working catheter. In yet another aspect, the first working catheter can 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 can introduce contrast media to an interventional site and the second working catheter can perform an interventional procedure. In a further aspect, the interventional procedure can include delivery of a prosthetic aortic valve. In still another aspect, the deployment catheter can be advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body can include proximally retracting the delivery sheath relative to the deployment catheter. In yet another aspect, the method can further include retrieving the radially expanded filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the filter body and draw the closed downstream end of the filter body into the delivery sheath. In an alternative aspect, retracting the deployment catheter to collapse the radially collapsible support can 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 filter body and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath. In yet another aspect, the collection chamber can be formed only by the inner layer of porous mesh. In still another aspect, the access port can be a self-sealing port. In another aspect the cylindrical filter body can have an open cylindrical chamber between a downstream end of the access port and the downstream end of the cylindrical filter body. In another aspect, the cylindrical filter body can have an open cylindrical chamber between an upstream end of the access port and the upstream end of the filter body. In yet another aspect the method can further include folding or closing a portion of the inner layer of the porous mesh radially inwardly to form the access port as the cylindrical filter body expands during the radially expanding the cylindrical filter body step. In still another aspect, the access port can have a downstream conical portion with its apex in the upstream direction; or, the access port can have an upstream conical portion with its apex in the downstream direction; or, the access port can have both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction; or the access port can have a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port can project upstream of the bottom of the open cylindrical chamber; or the access port can have a downstream conical portion with its apex in the- 12 -SG Docket No. 14925-719.600upstream direction, wherein the opening of the apex of the port can project upstream of the bottom of the open cylindrical chamber; or the access port can be located closer to an outer layer of the porous mesh and off-center from a central longitudinal axis of the cylindrical filter body. In yet another aspect, the access port can be a self-sealing port. In still another aspect, the method can further include forming the collection chamber adjacent to the access port during the radially expanding the cylindrical filter body step. In another aspect, the collection chamber can be formed only from the inner layer of the porous mesh. In a further aspect, the method can further include advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart. In yet another aspect, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second working catheter. In still another aspect, the radially collapsible support can include a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.

[0033] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch includes providing a cylindrical filter body, a radially collapsible support coupled to a periphery of the downstream end of the filter body, advancing a deployment catheter into the patient’s aortic arch, radially expanding the cylindrical filter body so a portion of the porous mesh covers one or more of the aortic side vessels of the patient’s aortic arch, with the upstream end of the cylindrical filter body towards the patient's heart to direct blood flow through the upstream end of the cylindrical filter body and emboli into the collection chamber, while the radially collapsible support radially expands holding the downstream end of the cylindrical filter body open, wherein blood free from emboli flows through the porous mesh into the one or more of the aortic side vessels of the patient’s aortic arch; and advancing a first working catheter through the open downstream end of the filter body and through the access port toward the heart. 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 the open upstream end and the open downstream end. The cylindrical filter body has an open cylindrical chamber between a downstream end of the access port and the downstream end of the cylindrical filter body or the cylindrical filter body has an open cylindrical chamber between an upstream end of the access port and the upstream end of the cylindrical filter body further wherein the open cylindrical chamber is formed only by an outer layer of the porous mesh. The radially collapsible support coupled to a periphery of the downstream end of the filter body, the cylindrical filter body has a radially- 13 -SG Docket No. 14925-719.600constrained delivery configuration, and a radially expanded deployed configuration. Advancing a deployment catheter into the patient’s 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 delivery configuration to position the filter body over the aortic arch.

[0034] This and other embodiments can include one or more of the following features. In one aspect, the method can further include advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart. In another aspect, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second working catheter. In yet another aspect, the first working catheter can 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 can introduce contrast media to an interventional site and the second working catheter performs an interventional procedure. In yet another aspect, the interventional procedure can include delivery of a prosthetic aortic valve. In a further aspect, the deployment catheter can be advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body can include proximally retracting the delivery sheath relative to the deployment catheter. In another aspect, the method can further include retrieving the radially expanded filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the filter body and draw the closed downstream end of the filter body into the delivery sheath. In still another aspect, retracting the deployment catheter to collapse the radially collapsible support can 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 filter body and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath. In yet another aspect, the collection chamber can be formed only by the inner layer of porous mesh. In another aspect, the access port can be a self-sealing port. In still another aspect, the method can further include folding or closing a portion of the inner layer of the porous mesh radially inwardly to form the access port as the cylindrical filter body expands during the radially expanding the cylindrical filter body step. In yet another aspect, the access port can have a downstream conical portion with its apex in the upstream direction; or, the access port has an upstream conical portion with its apex in the downstream direction; or, the access port has both a downstream conical portion with its apex in the upstream direction and an upstream conical- 14 -SG Docket No. 14925-719.600portion with its apex in the downstream direction; or the access port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber; or the access port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber; or the access port is located closer to an outer layer of the porous mesh and off-center from a central longitudinal axis of the cylindrical filter body. In an alternative aspect, the access port can be a self-sealing port. In still another aspect, the method can further include forming the collection chamber adjacent to the access port during radially expanding the cylindrical filter body step. In yet another aspect, the collection chamber can be formed only from the inner layer of the porous mesh. In still another aspect, the method can further include advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart. In another aspect, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second working catheter. In still another aspect, the radially collapsible support can include a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.

[0035] In general, in one embodiment, an embolic protection device includes a filter body, a radially collapsible support coupled to a periphery of the downstream 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. The filter body includes 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 port includes an expandable opening configured to conform to at least one working catheter passing therethrough. 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 with the support circumscribing the downstream end of the filter body and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the support and filter body back into the lumen of the delivery sheath such that the support radially collapses the downstream end of the filter body prior to the filter body being drawn into the lumen.

[0036] This and other embodiments can include one or more of the following features. In one aspect, the tubular porous mesh material of the filter body can include two layers (i.e., is “bi-layer”). In another aspect, the tubular porous mesh material of the filter body can be formed from one continuous mesh. In still another aspect, the filter body can have an open- 15 -SG Docket No. 14925-719.600cylindrical chamber between a downstream end of the port and the downstream end of the filter body. In yet another aspect, the filter body can have an open cylindrical chamber between an upstream end of the port and the upstream end of the filter body. In another aspect, the port can include a wall portion of the tubular porous mesh material which folds or closes radially inwardly as other wall portions expand when released from radial constraint from the delivery sheath. In still another aspect, the port can be formed from only the inner layer of a bi-layer mesh. In a further aspect, the wall portion can be radially inwardly collapsed to define the expandable opening of the port. In another aspect, the port can have a downstream conical portion with its apex in the upstream direction. In still another aspect, the port can have an upstream conical portion with its apex in the downstream direction. In yet another aspect, the port can have both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction. In another aspect, the port can have a downstream conical portion with its apex in the upstream direction; wherein the opening of the apex of the port can project upstream of the bottom of the open cylindrical chamber. In yet another aspect, the port can be located closer to a side wall of the tubular porous mesh and off-center from the longitudinal axis of the filter body. In still another aspect, the radially collapsible support can include a loop secured around the periphery of the downstream end of the filter body. In another aspect, the catheter body can have at least one deployment lumen which receives a tether attached to the radially collapsible support loop. In a further aspect, the loop can be configured as a lasso to allow the tether to draw the open end of the filter body closed prior to drawing the filter body into the lumen of the delivery sheath. In another aspect, the radially collapsible support can include a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body. In still another aspect, the catheter body can include at least a working catheter lumen for advancing a working catheter therethrough, into the open downstream end of the filter body, and through the port.

[0037] In general, in one embodiment, a method for advancing a working catheter over a patient's aortic arch includes providing a cylindrical filter body formed at least partly from a porous mesh which defines a collection chamber for emboli, advancing a deployment catheter into 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 filter body faces the patient's heart to direct blood flow through the upstream end and emboli into the collection chamber, and the support radially expands to hold the downstream end of the filter body open, wherein blood free from emboli flows through the porous mesh into the aortic side- 16 -SG Docket No. 14925-719.600vessels, and advancing a first working catheter through the open downstream end of the filter body and through the self-sealing port toward the heart. The filter body has 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 downstream end of the filter body, a radially constrained delivery configuration, and a radially expanded deployed configuration. Advancing a deployment catheter into the aortic arch, wherein a distal end of the deployment catheter is attached to the 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.

[0038] This and other embodiments can include one or more of the following features. In one aspect, a method can further include advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart. In yet another aspect, 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 can be introduced through a lumen in the deployment catheter and the second working catheter is introduced in parallel to the deployment catheter. In still another aspect, the first working catheter can introduce contrast media to an interventional site and the second working catheter performs an interventional procedure. In a further another aspect, the interventional procedure can include delivery of a prosthetic aortic valve. In an alternative aspect, the deployment catheter can be advanced while present in a delivery sheath which radially constrains the cylindrical filter body, and wherein radially expanding the cylindrical filter body can include proximally retracting the delivery sheath relative to the deployment catheter. In still another aspect, a method can further include retrieving the radially expanded filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the filter body 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 can 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 filter body and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath.

[0039] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.- 17 -SG Docket No. 14925-719.600BRIEF DESCRIPTION OF THE DRAWINGS

[0040] 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:

[0041] FIG. l is a partially exploded view of a first embodiment of an embolic protection device constructed in accordance with the principles of the present invention.

[0042] FIG. 2 is a detailed view of the connection between a filter body and a deployment catheter body of the embolic protection device of FIG. 1.

[0043] FIG. 3 is a detailed view shown in partial section of a tether structure which connects a downstream end of the filter body to an upstream or distal end of the catheter body of the embolic protection device of FIG. 1.

[0044] FIGS. 4 and 5 illustrate the loading of the filter body of the embolic protection device of FIG. 1 into the distal end of the delivery sheath using a filter loading tool.

[0045] FIG. 6 illustrates the contralateral positioning of the delivery sheath for placement of the embolic protection device and a separate transcatheter aortic valve replacement (TAVR) catheter as would be used for placement of a prosthetic heart valve using the embolic protection device of the present invention.

[0046] FIGS. 7A-7U illustrate positioning of the embolic protection device of the present invention over a patient's aortic arch and delivery of a prosthetic aortic valve through the embolic protection device in accordance with the methods of the present invention.

[0047] FIGS. 8A-8L illustrate a number of different folding patterns for a tubular porous mesh material in order to form filter bodies useful in the embodiments of the present invention.

[0048] FIGS. 9A-9F illustrate a number of different cross-sectional options for the geometry of the opening of the access port of the present invention.DETAILED DESCRIPTION

[0049] As shown in FIGS. 1-3, an embolic protection device 10 constructed in accordance with the principles of the present invention comprises a filter body 12 having an open upstream end 16 and an open downstream end 18. The filter body 12 is typically formed from a porous mesh material, more typically a tubular porous mesh material which is preformed to have an access port 20 with an expandable opening 22 located between the open upstream end 16 and the open downstream end 18, typically closer to the open downstream- 18 -SG Docket No. 14925-719.600end as illustrated. Specific folding patterns for the filter body 12 are described below with reference to FIGS. 8A-8J.

[0050] A radially expandable / collapsible support 24 is secured at the open downstream end 18 of the filter body 12, as best seen in FIG. 2. The radially collapsible support 24 may comprise a tube 34 (FIG. 3) having a pull wire 36 with a loop 37 formed at its distal end. The loop 37 is secured about the periphery of the open downstream end 18 of the filter body 12 so that it may act as a “lasso” or a “purse-string” component for opening and closing the open downstream end 18. In particular, by proximally retracting the pull wire 36 within the tube 34 (to the right in FIG. 3), the loop 37 may be closed. Conversely, by distally advancing the pull wire 36 relative to the tube 34, the loop 37 may be open. As described in more detail below, by axially advancing and retracting the tether structure 32, the filter body 12 may be positioned relative to a deployment catheter body 28.

[0051] The access port 20 of the filter body 12 divides the filter body into an upstream cylindrical chamber 26 A and a downstream cylindrical chamber 26B. Each of the chambers 26A and 26B will be generally free from internal structure, and the access port 20 will act to divide the two chambers and, in particular, to prevent passage of emboli which may enter the upstream chamber 26A into or beyond the downstream chamber 26B. The downstream cylindrical chamber 26B acts to receive and facilitate introduction of working catheters into and through the access port 20 in order to perform interventional procedures upstream of the filter body 12 when the filter body is deployed in the aorta or other blood vessels.

[0052] The deployment catheter body 28 has a distal end 30 and at least a first lumen 38 for carrying the tether structure 32 and a second lumen 40 which serves as a working lumen for introducing interventional or working catheters therethrough, such as TAVR catheters for deploying prosthetic aortic valves as will be described in detail below.

[0053] A proximal or control hub 29 is coupled to a proximal end 31 of the deployment catheter body 28. A proximal end 33 of the tether structure 32 extends from the control hub 29 and allows a user to manipulate the tether structure, including both axial retraction and advancement of the tether structure as well as opening and closing of the loop 37. The control hub 29 also has a port 35 which opens to the second lumen 40 in the catheter body 28 for allowing passage of guide wires, working catheters, and the like.

[0054] The filter body 12 will typically be self-expanding. By “self-expanding,”, it is meant that the filter body will be resilient and have a normally open or expanded configuration when free from radial and / or axial constraint. By either radially contracting or axially extending the filter body, the diameter or profile of the filter body will be reduced so that it can be intravascularly introduced to a working site in the patient's vasculature,- 19 -SG Docket No. 14925-719.600typically over the aortic arch but optionally in other locations as well. Additionally, by radially collapsing and / or axially extending the filter body, the access port within the filter body will be unfolded and axially extended.

[0055] The access port 20 will be self-forming, typically having a conical base 56 and a conical top 58, with an expandable opening 22 between them, as shown in FIG. 1. The access port 20 will have a structure that is formed by a narrowing of a portion of the larger tubular structure of the filter body as the radius of the filter body increases and the length of the filter body axially shortens. The filter body is typically made from a double-layer or “bi-layer” porous mesh material that has been formed from one continuous braid by everting the braid over itself. The necessary fold lines will be pre-formed into the filter body, typically by heat treatment. In exemplary embodiments, the filter body will be formed as a Nitinol® (nickeltitanium alloy) thin wire mesh which will be formed to have the fold lines described in more detail with reference to FIGS. 8A-8J below. Typically, the port as described above is formed only in the inner layer 53 of the mesh, with the outer layer 54 remaining at a larger diameter. The pre-formed fold lines will allow the filter body to be axially elongated and radially collapsed to have a low profile during delivery, typically having a delivery diameter below 12 Fr (French), often below 10 Fr. Conversely, the filter body will typically open to an unconstrained width or diameter above 5 mm, often above 15 mm more often above 25 mm, and typically in the range from 25 mm to 50 mm. As will be described in more detail below, the filter body 12 will be introduced in its low-profile configuration through a delivery sheath 42 which has been placed in the patient's artery, typically through the femoral artery over the aortic arch. The filter body 12 is axially elongated and radially collapsed and drawn into the lumen of the delivery sheath 42 using a filter loading tool 48, as shown in FIGS. 4 and 5. The delivery sheath and the catheter body 28 can be introduced over a guidewire structure 46 which has been pre-placed through a distal port 44 of the delivery sheath 42, as shown in FIGS. 4 and 5. To facilitate delivery, the delivery sheath 42 may have ports to allow the introduction of fluids into its lumens.

[0056] As shown in FIG. 6, the delivery sheath 42 will be introduced through the patient's groin into a femoral artery and up and over the aortic arch in a conventional manner. A second sheath 50, typically for introducing a TAVR or other interventional or working catheter, will be positioned in the contralateral femoral artery for introducing the working catheter up the aorta and over the aortic arch AA in parallel to the delivery sheath 42. Such positioning will be intended for prosthetic valve placement or other interventional procedures on the patient's P heart H.- 20 -SG Docket No. 14925-719.600

[0057] Referring now to FIGS. 7A-7U, a particular protocol for introducing a prosthetic valve PV into the patient's native aortic valve AV will be described. As shown in FIG. 7A, the delivery sheath 42 is initially placed over the guidewire structure 46 as just described with reference to FIG. 6. The delivery sheath 42 is retracted relative to the catheter body 28 such that the radially constrained filter body 12 approaches the open distal end 52 of the delivery sheath.

[0058] By then holding the catheter body 28 relatively still or stationary and further retracting the delivery sheath 42 in a proximal direction, i.e., away from the patient's aortic valve AV, the distal end of the filter body 12 will be released from constraint so that the tubular porous mesh 14 will begin to radially expand, as shown in FIG. 7B. The delivery sheath 42 continues to be proximally retracted, as shown FIG. 7C, so that the tubular porous mesh 14 expands and engages the inner wall of the ascending aorta immediately above the aortic valve AV. As shown in FIG. 7D, the delivery sheath 42 continues to be proximally withdrawn, allowing the tubular porous mesh 14 to continue to expand and to begin covering the branch vessels BV, with relative full deployment of the upstream cylindrical chamber 26 A of the filter body 12 shown in FIG. 7E.

[0059] As shown in FIG. 7F, the specific portion of the mesh that will form the access port 20 begins to form, as shown by the separation of the inner layer 53 and outer layer 54 sections of the port structure. Further proximal retraction of the delivery sheath 42 completes formation of the port 20 as shown in FIGS 7G and 7H. As also apparent in FIG. 7H, the radially collapsible support 24, in the form of the loop 37, opens to both open and support the open distal end of the downstream cylindrical chamber 26. It is this support structure 24 which allows the catheter body 28 to manipulate the downstream portion of the filter body 12 so that the downstream cylindrical chamber 26B can be advanced distally or toward the aortic valve AV relative to the upstream cylindrical chamber 26A. The radially expandable / collapsible support 24A will also be useful when retracting the filter body 12 at the end of the procedure, as will be described in more detail below.

[0060] A diagnostic catheter 60 may then be advanced over the guidewire 46, as shown in FIGS. 71 and 7J typically being used for angiography. This port 20 will expand to accommodate the diameter of the diagnostic catheter 60 while sealing around the catheter to prevent any emboli from passing through the port.

[0061] Another guidewire 62 may be introduced through the access port 20 for advancing a TAVR delivery catheter 64, as shown in FIG. 7J. The diagnostic catheter 60 will typically be left in place. The TAVR delivery catheter 64 is then advanced over the patient's aortic arch AA, as shown in FIG. 7K, until it passes through the native aortic valve AV, as - 21 -SG Docket No. 14925-719.600shown in FIG. 7L. A prosthetic valve PV will then be released from the TAVR catheter 64, as shown in FIG. 7M. It should be appreciated that during the advancement of the TAVR catheter 64 over the aortic arch AA, and in particular during release of the prosthetic valve PV, there is a substantial risk of emboli being released as the aortic arch and the aortic valve AV may be heavily calcified. If such emboli are present, they will be carried over the aortic arch and through open upstream end 16 of the filter body 12 so that they enter and are contained within the upper cylindrical chamber 26A. The captured emboli 65 are shown in FIG. 7M. In particular, the tubular porous mesh 14 will prevent emboli of any significant size from entering any of the branch vessels BV while allowing blood flow into these vessels. The access port 20 will conform to the exterior of the TAVR delivery catheter 64, thus reducing the likelihood of or preventing accidental passage of emboli through the port while it is expanded to permit catheter passage.

[0062] After the prosthetic valve PV has been released, as shown in FIG. 7M, the TAVR delivery catheter 64 will be proximally retracted over the guidewire 62, as shown in FIG. 7N. The TAVR delivery catheter 64 continues to be withdrawn and exits through the access port 20 which then closes over the TAVR guidewire 62 and diagnostic catheter 60, as shown in FIG. 70 and 7P. The TAVR guidewire 62 and diagnostic catheter 60 are both then pulled back through the access port and into the aorta downstream of the filter body, leaving the filter free of other devices and ready for retrieval, as shown in FIG. 7Q.

[0063] After the TAVR guidewire 62 and diagnostic catheter 60 have been withdrawn, the prosthetic valve PV is in place and it is necessary to withdraw the filter body 12 from the aortic arch AA. The tether structure 32 is manipulated to close the loop 37 of the radially collapsible support 24 and the proximal end of the filter structure 12 is drawn into the distal end of delivery sheath 42 by retraction of the catheter body 28, as shown in FIG. 7R.

[0064] The catheter body 28 continues to be proximally withdrawn until the entire filter body 12 is drawn into the delivery sheath 42, as shown in FIGS. 7S, 7T, and 7U. The filter body and all emboli contained therein are then safely captured within the delivery sheath 42, and the delivery sheath 42 may be withdrawn from the patient and the procedure may be completed in a conventional manner.

[0065] The porous filter 14 mesh material may comprise a variety of knitted, woven or nonwoven fibers, filaments or wires, and will have a pore size chosen to allow blood to pass through but prevent emboli above a certain size from passing through. Suitable materials include resilient metals, such as shape and heat memory alloys, polymers, and combinations thereof, and the materials may optionally have an anti-thrombogenic coating (such as heparin) on their surfaces. The filter meshes may further incorporate materials and structures- 22 -SG Docket No. 14925-719.600to enhance the radiopacity of the filter body. Exemplary materials include gold, platinum, palladium, or tantalum, and other metals having a greater radiopacity than the resilient metals, as well as radiopaque coatings or fillings. In other cases, the resilient metal filaments or wires may be served with thinner, more radiopaque wires or filaments.

[0066] The filter body 12 may be constructed in discrete sections that are attached together, but will more typically be formed from a continuous cylindrical mesh structure that is narrowed or folded in sections to form the specific design features, typically consisting of a single such folded tubular mesh structure. Forming the device from one continuous cylindrical mesh allows the filter body to be axially stretched for deployment and / or retrieval, thereby reducing the profile of the filter. Another advantage of a filter formed from a single, continuous tabulate mesh material is that it will contain only smooth, rounded edges. Such edges minimize friction and snagging with catheters and the procedural tools being introduced through the filters.

[0067] The access port may be configured as a conical structure with the access port at its narrow end, typically formed by a sleeve as described previously. In other embodiments, as illustrated below, the access port may be a simple narrowing of the cylindrical structure, e.g. a self-closing neck region which seal around catheters and other tools introduced therethrough. Whatever the particular geometry, the access port can be formed by shapesetting a larger, tubular or cylindrical mesh in a reduced diameter via heat treatment or cold forming. In addition, other embodiments of the access port can be straight, contain a twist, be corrugated, have a flattened section, or possess other features that assist in its ability to close around procedural devices sufficiently to inhibit or prevent emboli from passing through when a catheter is in place. In still other embodiments, the filter body may contain two or more such self-expanding port structures. The port 20 may accommodate a single device (such as a guidewire, catheter, valve delivery system, pacing lead, etc.), two devices or more than two devices simultaneously and can expand and contract to maintain a sufficient seal around multiple devices as needed. Further, such devices can be introduced through the downstream cylindrical chamber 26B and into the port 20 by way of the working lumen 40 of the catheter body 28 or directly by way of a second sheath 50 in an alternative access site, or in some combination thereof.

[0068] Referring now to FIGS. 8A-8J, a number of different patterns for forming the tubular porous mesh material 14 of the present invention into a filter body 12 having the access port 20 between the upstream cylindrical chamber 26A and the downstream cylindrical chamber 26B are illustrated. It will be appreciated that each of the structures in FIGS. 8A-8J begins with a single layer tube of a mesh material as just described.- 23 -SG Docket No. 14925-719.600

[0069] In the configuration of FIG. 8 A which is another view of the device of FIG. 1, the tubular structure is first folded into a bi-layer structure having a fold at its downstream end 18 and free ends to the two layers of the porous mesh (i.e., the inner layer 53 and the outer layer 54) at the upstream end 16. The bi-layer structure is then folded back upon itself and everted in order to form the illustrated filter body 12 having a structure which is then heat set in the fully radially expanded configuration. The access port 20 is creating by forming a narrowed section 22 in the inner layer 53 of the porous mesh, with a conical base 56 and a conical top 57.

[0070] The filter bodies 12 of FIGS. 8B-8C similarly begin as a bi-layer tubular mesh with a single fold at the downstream end 18. The bi-layer structure is then folded similarly to the pattern of FIG. 8 A. The primary difference with FIG. 8B is that the narrowed section 22 of the access port 20 is located more preferentially toward the upstream direction, which creates a somewhat flattened (or shallower conical) top section 68. In the filter of FIG. 8C is the narrowed section 22 of the access port 20 is located more preferentially toward the downstream direction, which creates a somewhat flattened (or shallower conical) bottom section 69.

[0071] The filter body 12 illustrated in FIG. 8D is again similar in most respects to the fold pattern of filter 12 of FIG. 8B, except that narrowed section 22 of the access port 20 is located even more preferentially toward the upstream direction, such that the upstream end of the access port 20 projects to a point upstream of the downstream end of the upstream cylindrical chamber 26A, forming a shallow “volcano” shape 70.

[0072] The filter body 12 illustrated in FIG. 8E is similar to the fold-pattern of FIG. 8A, but with two in-line narrowed sections 22 and 22b, forming a downstream access port 20 and a second upstream access port 59.

[0073] The filter body 12 illustrated in FIG. 8F is similar to the fold-pattern of FIG. 8E with two access ports, but with each of the two in-line narrowed sections 22 and 22b offset laterally from the center line of the filter, one in one direction and the other one in the opposite direction.

[0074] In the configuration of FIG. 8G, the primary steps to produce the final shape are similar to FIGS. 8A-8F in that the tubular structure is first folded into a bi-layer structure having a fold at its downstream end 18 and free ends to the two layers of the porous mesh (i.e., the inner layer 53 and the outer layer 54) at the upstream end 16. The bi-layer structure is then folded back upon itself and everted in order to form the illustrated filter body 12 having a structure which is then heat set in the fully radially expanded configuration. The access port 20 is creating by folding and inverting one side of the inner layer 53 to form an - 24 -SG Docket No. 14925-719.600asymmetrical, double layer access port along the opposite side of the filter body. The port as formed comprises a partial conical base 56c and an elongated narrowed section 22 that projects upstream from the partial conical base 56c.

[0075] In the configuration of FIG. 8H, the primary steps to produce the final shape are similar to FIGS. 8A-8G as described above. However, the access port 20 is created by folding the inner layer 53 toward the opposite wall of the mesh to form an asymmetrical access port along the opposite side of the filter body. The port as formed comprises a partial conical base 56c, a partial conical top 57c, and an elongated narrowed section 22 between them.

[0076] The filter body 12 of FIG. 81 is similar to FIGS. 8A-8D as it is a bi-layer tubular mesh with a single fold at the downstream end 18. The access port 20 is created by folding and inverting the inner layer 53 to form a conical, double layer access port. The port as formed comprises a conical base 56, a narrowed section 22, and a port extending sleeve 58 that projects upstream from the conical base 56. The filter body of FIG. 81 adds an additional feature not shown in the previous designs, which is a flared portion 67 at the upstream open end 16 of the filter body 12. This flared feature can be incorporated in any of the folding patterns shown in FIGS. 8A-8J.

[0077] The filter body 12 of FIG. 8J is similar to FIG. 8A in that the tubular structure is first folded into a bi-layer structure having a fold at its downstream end 18 and free ends to the two layers of the porous mesh (i.e., the inner layer 53 and the outer layer 54) at the upstream end 16. The bi-layer structure is then folded back upon itself and everted in order to form the illustrated filter body 12 having a structure which is then heat set in the fully radially expanded configuration. The access port 20 is creating by forming a narrowed section 22 in the inner layer 53 of the porous mesh, with a conical base 56 and a conical top 57. The filter body of FIG. 8 J adds an additional feature not shown in the previous designs, which is a larger diameter portion 66 in the upstream cylindrical chamber 26A of the filter body 12. The previous fold patterns shown in FIGS. 8A-8H had a consistent diameter along the length of the filter. Multiple diameter changes along the length of the filter body 12, that may include both multiple stepwise increases in diameter along its length or even portions with a reduced diameter are within the scope of the invention disclosure. Multiple filter body diameters can be incorporated any of the folding patterns shown in FIGS. 8A-8J, including in the upstream cylindrical chamber 26A, in the downstream cylindrical chamber 26B, and in the outer layer 54 in the region of the access port 20.

[0078] The filter body 12 illustrated in FIG. 8K is similar to the fold-pattern of FIG. 8A, but with the access port 20 located toward the middle of the filter body 12, resulting in- 25 -SG Docket No. 14925-719.600roughly equal lengths for the upstream cylindrical chamber 26A and the downstream cylindrical chamber 26B.

[0079] The filter body 12 illustrated in FIG. 8L is similar to the fold-pattern of FIGS. 8A and 8K, but with the access port 20 located toward the upstream end of the filter body 12, resulting in a shorter upstream cylindrical chamber 26A and a longer downstream cylindrical chamber 26B. It can be appreciated that any of the fold patterns shown in FIGS. 8A-8L can be produced with the access port 20 located anywhere along the length of the filter body 12. However, in an optimum design, there would be sufficient length to the upstream cylindrical chamber 26A to provide adequate space for captured emboli, and adequate length to the downstream cylindrical chamber 26B to provide a sufficient open space to allow for more favorable access to interventional devices to enter the filter body.

[0080] Referring now to FIGS. 9A-9F, a number of different ways to form the shape of the expandable opening 22 of the access port 20 from the tubular porous mesh material 14 are illustrated. These shapes may include a circular opening with a small cross section (FIG. 9A), a circular opening with a large cross section (FIG. 9B), a slit-like opening comprising a narrow, elongated elliptical shape (FIG. 9C), a cross-shaped opening with four lobes (FIG. 9D), a triangular opening with three lobes (FIG. 9E), and a crescent shaped opening (FIG. 9F).

[0081] Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the invention disclosure.

[0082] While some embodiments of an exemplary embolic protection device have been described with a single inner layer and a single outer layer, other configurations are possible and within the scope of the various inventive embolic protection devices described herein. It is to be appreciated that the inner layer and / or the outer layer of an embolic protection device embodiment may include one or more layers. Variations in the number of inner layers and / or outer layers may advantageously be employed to modify or adjust various structural, performance or filtering characteristics of the embolic protection devices described herein. Additionally or optionally, an outer layer may have one or more layers while an inner layer may have one or more layers, in any combination.

[0083] 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.- 26 -SG Docket No. 14925-719.600

[0084] The uses and design elements of other embolic protection devices, filters and devices for preventing cerebral embolism such as those described in U.S. Patent Publ. Nos. 2013 / 0178891; 2010 / 0312268; 2006 / 0287668; 2005 / 0010246; 2005 / 0283186; 2004 / 0215167; and 2003 / 0100940; PCT Publ. WO / 2004 / 019817; and U.S. Pat. Nos. 8,114,114; 7,232,453; 6,712,834; 6,537,297; 6,499,487; 6,371,935; 6,361,545; 6,258,120; 6,254,563; 6,245,012; 6,139,517; and 5,769,819 may be adapted in whole or in part to take advantage of the various embodiments described herein.

[0085] 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.

[0086] 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. It 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.

[0087] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. 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.- 27 -SG Docket No. 14925-719.600As 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 " / ".

[0088] 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.

[0089] 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 below could be termed a first feature / element without departing from the teachings of the present invention.

[0090] 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.

[0091] 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.

[0092] 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 - 28 -SG Docket No. 14925-719.600the 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 are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0093] 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 invention 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 invention as it is set forth in the claims.

[0094] 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- 29 -SG Docket No. 14925-719.600intending 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.- 30 -SG Docket No. 14925-719.600

Claims

CLAIMSWhat is claimed is:

1. An embolic protection device, comprising: a filter body comprising a tubular porous mesh material having an inner layer and an outer layer, the filter body having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said port comprising an expandable opening configured to conform to at least one working catheter passing therethrough, wherein the port is formed from only an inner layer of the filter body; a radially collapsible support coupled to a periphery of the open downstream 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 with the radially collapsible support circumscribing the open downstream end of the filter body and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the radially collapsible support and filter body back into the lumen of the delivery sheath such that the radially collapsible support radially collapses the open downstream end of the filter body prior to the filter body being drawn into the lumen.

2. The embolic protection device of claim 1, wherein the tubular porous mesh material of the filter body is formed from one continuous mesh.

3. The embolic protection device of claim 1, wherein the filter body has an open cylindrical chamber between a downstream end of the port and the downstream end of the filter body.

4. The embolic protection device of claim 1, wherein the filter body has an open cylindrical chamber between an upstream end of the port and the upstream end of the filter body.- 31 -SG Docket No. 14925-719.6005. The embolic protection device of claim 1, wherein the port comprises a portion of the inner layer of the tubular porous mesh material which folds or closes radially inwardly as filter body expands when released from radial constraint from the delivery sheath.

6. The embolic protection device of claim 5, wherein the wall portion of the inner layer is radially inwardly collapsed to define the expandable opening of the port.

7. An embolic protection device of claim 6, wherein the port has a downstream conical portion with its apex in the upstream direction.

8. The embolic protection device of claim 6, wherein the port has an upstream conical portion with its apex in the downstream direction.

9. The embolic protection device of claim 6, wherein the port has both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction.

10. The embolic protection device of claim 4, wherein the port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber.

11. The embolic protection device of claim 5, wherein the port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber.

12. The embolic protection device of any one of claims 6 through 11, wherein the port is located closer to the outer layer of the tubular porous mesh and off-center from a central longitudinal axis of the filter body.

13. The embolic protection device of claim 1, wherein the radially collapsible support comprises a loop secured around the periphery of the downstream end of the filter body.

14. The embolic protection device of claim 13, wherein the catheter body has at least one deployment lumen which receives a tether attached to the loop.

15. The embolic protection device of claim 13, wherein the loop is configured as a lasso to allow the tether to draw the open end of the filter body closed prior to drawing the filter body into the lumen of the delivery sheath.- 32 -SG Docket No. 14925-719.60016. The embolic protection device of claim 1, wherein the radially collapsible support comprises a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.

17. The embolic protection device of claim 1, wherein the catheter body includes at least a working catheter lumen for advancing a working catheter therethrough, into the open downstream end of the filter body, and through the port.

18. An embolic protection device, comprising: a filter body comprising a tubular porous mesh material having an inner layer and an outer layer, the filter body having an open upstream end, an open downstream end, and an access port spaced inwardly from each of said ends, said port comprising an expandable opening configured to conform to at least one working catheter passing therethrough; wherein the filter body has an open cylindrical chamber between a downstream end of the access port and the downstream end of the filter body or the filter body has an open cylindrical chamber between an upstream end of the access port and the upstream end of the filter body further wherein the open cylindrical chamber is formed only by the outer layer of the filter body; a radially collapsible support coupled to a periphery of the open downstream 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 with the radially collapsible support circumscribing the open downstream end of the filter body and wherein the catheter body may be distally retracted relative to the delivery sheath to pull the radially collapsible support and filter body back into the lumen of the delivery sheath such that the radially collapsible support radially collapses the open downstream end of the filter body prior to the filter body being drawn into the lumen.

19. The embolic protection device of claim 18, wherein the tubular porous mesh material of the filter body is formed from one continuous mesh.- 33 -SG Docket No. 14925-719.60020. The embolic protection device of claim 18, wherein the port comprises a portion of the inner layer of the tubular porous mesh material which folds or closes radially inwardly as filter body expands when released from radial constraint from the delivery sheath.

21. The embolic protection device of claim 20, wherein the wall portion of the inner layer is radially inwardly collapsed to define the expandable opening of the port.

22. The embolic protection device of claim 21, wherein the port has a downstream conical portion with its apex in the upstream direction.

23. The embolic protection device of claim 21, wherein the port has an upstream conical portion with its apex in the downstream direction.

24. The embolic protection device of claim 21, wherein the port has both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction.

25. The embolic protection device of claim 18, wherein the port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber.

26. The embolic protection device as in any one of claims 21 through 25, wherein the port is located closer to the outer layer of the tubular porous mesh and off-center from a central longitudinal axis of the filter body.

27. The embolic protection device of claim 18, wherein the radially collapsible support comprises a loop secured around the periphery of the downstream end of the filter body.

28. The embolic protection device of claim 27, wherein the catheter body has at least one deployment lumen which receives a tether attached to the loop.

29. The embolic protection device of claim 27, wherein the loop is configured as a lasso to allow the tether to draw the open end of the filter body closed prior to drawing the filter body into the lumen of the delivery sheath.

30. The embolic protection device of claim 18, wherein the radially collapsible support comprises a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.- 34 -SG Docket No. 14925-719.60031. The embolic protection device of claim 18, wherein the catheter body includes at least a working catheter lumen for advancing a working catheter therethrough, into the open downstream end of the filter body, and through the port.

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 formed only from an inner layer of the porous mesh, the access port spaced inwardly from each of the open upstream end and the open downstream end, a radially collapsible support coupled to a periphery of the downstream end of the filter body, the cylindrical filter body having a radially constrained delivery configuration, and a radially expanded deployed configuration; advancing a deployment catheter into the patient’s 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 delivery configuration to position the filter body over the aortic arch; radially expanding the cylindrical filter body so a portion of the porous mesh covers one or more of the aortic side vessels of the patient’s aortic arch, with the upstream end of the cylindrical filter body towards the patient's heart to direct blood flow through the upstream end of the cylindrical filter body and emboli into the collection chamber, while the radially collapsible support radially expands holding the downstream end of the cylindrical filter body open, wherein blood free from emboli flows through the porous mesh into the one or more of the aortic side vessels of the patient’s aortic arch; and advancing a first working catheter through the open downstream end of the filter body and through the access port toward the heart.

33. The method of claim 32, further comprising advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart.

34. The method of 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 working catheter.- 35 -SG Docket No. 14925-719.60035. The method of 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. The method of claim 34, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

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

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

40. The method of 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 filter body and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath.

41. The method of claim 32, wherein the collection chamber is formed only by the inner layer of porous mesh.

42. The method of claim 32, wherein the access port is a self-sealing port.

43. The method of claim 32, wherein the cylindrical filter body has an open cylindrical chamber between a downstream end of the access port and the downstream end of the cylindrical filter body.

44. The method of claim 32, wherein the cylindrical filter body has an open cylindrical chamber between an upstream end of the access port and the upstream end of the filter body.- 36 -SG Docket No. 14925-719.60045. The method of claim 43 or 44, further comprising: folding or closing a portion of the inner layer of the porous mesh radially inwardly to form the access port as the cylindrical filter body expands during the radially expanding the cylindrical filter body step.

46. The method of claim 45, wherein the access port has a downstream conical portion with its apex in the upstream direction; or, the access port has an upstream conical portion with its apex in the downstream direction; or, the access port has both a downstream conical portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction; or the access port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber; or the access port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber; or the access port is located closer to an outer layer of the porous mesh and off-center from a central longitudinal axis of the cylindrical filter body.

47. The method of claim 46, wherein the access port is a self-sealing port.

48. The method of claim 46, further comprising forming the collection chamber adjacent to the access port during the during the radially expanding the cylindrical filter body step.

49. The method of claim 46, wherein the collection chamber is formed only from the inner layer of the porous mesh.

50. The method of claim 46, further comprising advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart.

51. The method of claim 50, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second working catheter.

52. The method of claim 32, wherein the radially collapsible support comprises a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.

53. A method for advancing a working catheter over a patient's aortic arch, said method comprising:- 37 -SG Docket No. 14925-719.600providing 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 the open upstream end and the open downstream end, wherein the cylindrical filter body has an open cylindrical chamber between a downstream end of the access port and the downstream end of the cylindrical filter body or the cylindrical filter body has an open cylindrical chamber between an upstream end of the access port and the upstream end of the cylindrical filter body further wherein the open cylindrical chamber is formed only by an outer layer of the porous mesh; a radially collapsible support coupled to a periphery of the downstream end of the filter body, the cylindrical filter body having a radially constrained delivery configuration, and a radially expanded deployed configuration; advancing a deployment catheter into the patient’s 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 delivery configuration to position the filter body over the aortic arch; radially expanding the cylindrical filter body so a portion of the porous mesh covers one or more of the aortic side vessels of the patient’s aortic arch, with the upstream end of the cylindrical filter body towards the patient's heart to direct blood flow through the upstream end of the cylindrical filter body and emboli into the collection chamber, while the radially collapsible support radially expands holding the downstream end of the cylindrical filter body open, wherein blood free from emboli flows through the porous mesh into the one or more of the aortic side vessels of the patient’s aortic arch; and advancing a first working catheter through the open downstream end of the filter body and through the access port toward the heart.

54. The method of claim 53, further comprising advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart.

55. The method of claim 54, performing a first diagnostic or interventional procedure with the first working catheter and performing a second diagnostic or interventional procedure with the second working catheter.- 38 -SG Docket No. 14925-719.60056. The method of claim 55, 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.

57. The method of claim 55, wherein the first working catheter introduces contrast media to an interventional site and the second working catheter performs an interventional procedure.

58. The method of claim 55, wherein the interventional procedure comprises delivery of a prosthetic aortic valve.

59. The method of claim 54, 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.

60. The method of claim 59, further comprising retrieving the radially expanded filter body by retracting the deployment catheter to collapse the radially collapsible support to close the open downstream end of the filter body and draw the closed downstream end of the filter body into the delivery sheath.

61. The method of claim 60, 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 filter body and then retracting the deployment catheter to draw the closed downstream end of the filter body into the delivery sheath.

62. The method of claim 53, wherein the collection chamber is formed only by the inner layer of porous mesh.

63. The method of claim 53, wherein the access port is a self-sealing port.

64. The method of claim 62 or 63, further comprising: folding or closing a portion of the inner layer of the porous mesh radially inwardly to form the access port as the cylindrical filter body expands during the radially expanding the cylindrical filter body step.

65. The method of claim 64, wherein the access port has a downstream conical portion with its apex in the upstream direction; or, the access port has an upstream conical portion with its apex in the downstream direction; or, the access port has both a downstream conical- 39 -SG Docket No. 14925-719.600portion with its apex in the upstream direction and an upstream conical portion with its apex in the downstream direction; or the access port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber; or the access port has a downstream conical portion with its apex in the upstream direction, wherein the opening of the apex of the port projects upstream of the bottom of the open cylindrical chamber; or the access port is located closer to an outer layer of the porous mesh and off-center from a central longitudinal axis of the cylindrical filter body.

66. The method of claim 65, wherein the access port is a self-sealing port.

67. The method of claim 65, further comprising forming the collection chamber adjacent to the access port during the radially expanding the cylindrical filter body step.

68. The method of claim 65, wherein the collection chamber is formed only from the inner layer of the porous mesh.

69. The method of claim 65, further comprising advancing a second working catheter through the open downstream end of the filter body and through the access port toward the heart.

70. The method of 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 working catheter.

71. The method of claim 53, wherein the radially collapsible support comprises a scaffold having an open end coupled to the periphery of the downstream end of the filter body and a constricted end coupled to the distal end of the catheter body.- 40 -SG Docket No. 14925-719.600

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