FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of intra-aortic devices.

In Transcatheter Aortic-Valve Implantation and/or Replacement (TAVI and TAVR, respectively), a catheter-based delivery system and compressed/crimped prosthetic valve may be inserted through one of the arteries and advanced to the aortic root. After careful positioning of the device in the native aortic valve, the new prosthetic valve may be deployed and may immediately function as a new aortic valve.

In on-pump procedures, heart-lung machine procedures, such as aortic valve replacement (SAVR), mitral valve replacement or repair (MVR), coronary artery bypass grafts (CABG) and other cardiac surgeries, the patient may be put on a cardiopulmonary bypass pump, and after cardiopulmonary bypass pump cross-clamp release.

The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.

SUMMARY OF THE INVENTION

An aspect of some embodiments of the invention includes an intra-aortic emboli protection filter apparatus and methods for deflecting and/or capturing and/or removal of emboli particles dislodged into the blood during various cardiac interventional procedures.

An aspect of some embodiments of the invention includes a device which includes a filter-covered collapsible wire structure with one or more cross luminal element such as filter flap(s) or pocket(s) for preventing emboli particles from migrating into certain areas of the anatomy. In some embodiments, blood flow through the cross luminal elements pushes the edges of the filter to block the lumen, thereby filtering the entire cross section of the lumen. In some embodiments the device is optionally placed downstream from the aortic valve to deflect particles toward the descending aorta to capturing filter flap(s) or pocket(s). In some embodiments the device protects the walls of the aorta from the valve delivery system/other devices used in the procedure. In some embodiments the device upstream end is optionally placed in the aortic arch and the device downstream end in the descending aorta. In some embodiments the device is collapsible and can be deployed and removed using a catheter-based delivery system. In some embodiments capturing emboli particles includes using two or more adjoined filter pockets connected to the downstream part of the device to capture the emboli particles flowing downstream. In some embodiments removing emboli particles includes removing the device together with the emboli particles captured in the filter pockets.

The term “filter”, as referred to herein, may relate to a porous sheet or a porous body of material, which serves for filtering blood and preventing emboli from passing through it while allowing blood without emboli, or at least without emboli larger than the pore size, to pass through the filter. One example of a filter is a mesh—a woven, knit, or knotted material, such as a mesh made of suitably arranged nitinol wires. Another example of a filter is a polymeric membrane having holes of such a size and density preventing emboli from passing therethrough. Such polymeric membrane may be taut over a relatively rigid frame. The membrane may have a uniform or a variable thickness in the range of 0.05 mm to 0.25 mm, as one example. Other thicknesses are also intended herein.

Generally, it is intended that the term “filter” covers any material with holes, whether evenly or unevenly spaced, which can serve for filtering blood and preventing emboli from passing through it while allowing blood without emboli, or at least without emboli larger than the pore size, to pass through the filter.

The terms “upstream” and “downstream” are used throughout the present specification and claims based on a direction of blood flow in a patient's body.

As using herein, the terms “conform”, “conforming”, and the like mean that two or more objects may have identical or similar shapes. For example, a medical device or a portion thereof said to conform to a certain anatomic structure, has a shape identical or similar to that of the anatomic structure.

According to an aspect of some embodiments of the present invention there is provided an embolic protection device comprising a porous deflector screen comprising a filter shaped as curved cylinder portion when the embolic protection device is in an expanded configuration, where the porous deflector screen is configured to expand and to conform to a wall of the aortic arch, covering entrances to arteries branching from the superior wall of the aortic arch. The embolic protection device comprises an emboli collector shaped as a cylinder when the embolic protection device is in the expanded configuration, where the emboli collector is configured to expand and to lie along walls of the descending aorta, pushing against walls of the descending aorta and anchoring the porous deflector screen, where the emboli collector comprises one or more elongated filter pocket having an opening directed towards the porous deflector screen. The concavity of the one or more elongated filter pocket is directed opposite to the opening. When the embolic protection device is in an expanded configuration, the one or more elongated filter pocket spans at least partway a cylindrical volume, with the length of the one or more elongated filter pocket being along the height of the cylindrical volume. The embolic protection device comprises a connecting portion for connecting the porous deflector screen and the emboli collector, configured to push the porous deflector screen against the superior wall of the aortic arch while anchoring against the emboli collector.

Optionally, the porous deflector screen comprises an expandable frame.

Optionally, the emboli collector comprises a filter.

An aspect of some embodiments of the invention includes a filter sized to expand and to lie along walls of a descending aorta, the filter comprising holes designed to filter blood through and block emboli.

Optionally, the porous deflector screen comprises an expandable frame.

Optionally, the connecting portion is longer than 2 centimeters.

Optionally, the connecting portion is longer than 7 centimeters.

Optionally, the connecting portion is shaped to expand to the shape of a curved cylinder portion.

Optionally, the one or more elongated filter pocket comprises a plurality of elongated filter pockets disposed in parallel.

Optionally, the emboli collector is shaped to expand to a cylindrical shape.

Optionally, the emboli collector comprises support struts.

Optionally, the emboli collector comprises an expandable stent-like shape.

Optionally, the one or more elongated filter pocket comprises a frame at an edge of the opening.

Optionally, one or more radio-opaque marker is attached to the opening.

Optionally, the device comprises one or more radio-opaque marker.

Optionally, the one or more radio-opaque marker is attached to the porous deflector screen.

Optionally, the one or more radio-opaque marker is attached to the emboli collector.

Optionally, the one or more radio-opaque marker is attached to the connecting portion.

Optionally, at least some of the plurality of elongated filter pockets are at least partially directly attached to each other.

Optionally, the one or more elongated filter pocket comprises a mechanism for closing the opening.

Optionally, the device further includes radio-opaque markers for distinguishing when the one or more elongated filter pocket is open and when the one or more elongated filter pocket is closed.

Optionally, the mechanism comprises a cord for drawing closed the opening when the cord is pulled.

Optionally, one or more downstream end of one or more of the plurality of elongated filter pockets is at a different distance from an upstream end of the emboli collector than one or more other end of one or more other of the plurality of pockets.

Optionally, the downstream ends of the plurality of elongated filter pockets are at a same distance from an upstream end of the emboli collector.

Optionally, the plurality of elongated filter pockets have different sized pocket openings.

Optionally, one or more of the plurality of elongated filter pockets has a different width than one or more other of the plurality of elongated filter pockets.

Optionally, the emboli collector is structured to overlap by at least 10% of a circumference of the descending aorta.

Optionally, the emboli collector is structured to overlap by at least 30% of a circumference of the descending aorta.

Optionally, the surface of the emboli collector is structured to overlap by at least 50% of a circumference of the descending aorta.

Optionally, the emboli collector further comprises support struts.

Optionally, the emboli collector further comprises stent-like support struts.

Optionally, the emboli collector further comprises a frame.

Optionally, the filter of the porous deflector screen further comprises support struts attached to the filter.

Optionally, the filter of the porous deflector screen further comprises a frame attached to a circumference of the filter.

Optionally, the emboli collector further comprises a wire arranged to extend downstream.

Optionally, the wire further comprises a ring.

Optionally, the wire further comprises a radio-opaque marker at its downstream end.

Optionally, the porous deflector screen is arranged to anchor against walls of the aortic arch by applying radial force to the walls of the aortic arch.

Optionally, the emboli collector is arranged to anchor against walls of the descending aorta by applying radial force to the walls of the descending aorta.

According to an aspect of some embodiments of the present invention there is provided an embolic protection device comprising a surface arranged to expand and to lie along walls of a blood vessel, pushing against walls of the blood vessel. The embolic protection device further comprises a plurality of filter pockets attached to the surface, each one of the filter pockets arranged to extend at least partway across a lumen of the blood vessel, for trapping emboli flowing downstream, where the plurality of pockets are arranged to enable a surgical tool to pass through the lumen between the filter pockets.

According to an aspect of some embodiments of the present invention there is provided a method for protecting a patient against flow of emboli from an aorta to branching arteries, the method comprising providing a device and inserting the device via a catheter into an aorta. The device comprises a porous deflector screen comprising a filter shaped as curved cylinder portion when the embolic protection device is in an expanded configuration, where the porous deflector screen is configured to conform to a superior wall of the aortic arch, covering entrances to arteries branching from the aorta. The device comprises an emboli collector shaped as a cylinder when the embolic protection device is in the expanded configuration, where the emboli collector is configured to expand and to lie along walls of the descending aorta, pushing against walls of the descending aorta and anchoring the porous deflector screen, where the emboli collector comprises one or more elongated filter pocket having an opening directed towards the porous deflector screen. The concavity of the one or more elongated filter pocket is directed opposite to the opening. When the embolic protection device is in an expanded configuration, the one or more elongated filter pocket spans at least partway a cylindrical volume, with the length of the one or more elongated filter pocket being along the height of the cylindrical volume. The device comprises a connecting portion for connecting the porous deflector screen and the emboli collector, configured to push the porous deflector screen against the superior wall of the aortic arch while anchoring against the emboli collector. The porous deflector screen is placed at the aortic arch, the filter of the porous deflector screen blocking exits to arteries branching superiorly off the aortic arch. The emboli collector is placed at the descending aorta and unfurled so the surface lies along walls of the descending aorta.

Optionally, the method further comprises using a catheter to remove the device from the aorta.

Optionally, the method further comprises closing the opening of the one or more elongated filter pocket prior to removing the device from the aorta.

Optionally, the method further comprises closing the opening of the one or more elongated filter pocket by pulling a cord for drawing closed the opening prior to removing the device from the aorta.

Optionally, the method further comprises performing a procedure on a heart of the patient by passing a surgical tool through the emboli collector of the device, next to the filter pocket.

Optionally, the one or more elongated filter pocket comprises a plurality of elongated filter pockets, and further comprising performing a procedure on a heart of the patient by passing a surgical tool through the emboli collector of the device, between the plurality of elongated filter pockets.

Optionally, the method further comprises, following the inserting, performing an on-pump cardiac operation on a heart of the patient.

Optionally, the method further comprises leaving the device within the aorta following conclusion of the on-pump cardiac operation.

Optionally, the method further comprises using a catheter to remove the device from the aorta.

According to an aspect of some embodiments of the present invention there is provided a method for distinguishing between an open state and a closed state of a flexible pocket implanted in a patient. The method comprises using at least two radio-opaque markers attached to the pocket. The method comprises imaging the at least two radio-opaque markers. The method comprises determining whether the flexible pocket is open or closed based, at least in part, on a distance between the radio-opaque markers.

According to an aspect of some embodiments of the present invention there is provided an embolic protection device comprising an upstream portion comprising a filter, arranged to expand and to conform to a wall of the aortic arch covering entrances to arteries branching from an aortic arch. The device comprises a downstream portion comprising an expandable shape arranged to expand and to lie along walls of a descending aorta, pushing against walls of the descending aorta and at least partially anchor the embolic protection device. The device comprises a filter pocket attached to the expandable shape of the downstream portion, arranged to extend from the walls of the descending aorta at least partway across a lumen of the descending aorta, for trapping emboli flowing downstream. The device comprises a connecting portion for connecting the upstream portion and the downstream portion, arranged to push the upstream portion against walls of the aortic arch while anchoring against the downstream portion.

According to an aspect of some embodiments of the present invention there is provided an embolic protection device comprising an upstream portion comprising a filter, arranged to expand and to conform to a wall of the aortic arch covering entrances to arteries branching from an aorta. The device comprises a downstream portion comprising a surface arranged to expand and to lie along walls of a descending aorta, pushing against walls of the descending aorta and anchoring the upstream portion. The device comprises a connecting portion for connecting the upstream portion and the downstream portion, arranged to push the upstream portion against a wall of the aortic arch while anchoring against the downstream portion.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

