Patent Description:
The present invention, relates to a device that is configured to be inserted into an aorta and, more particularly, but not exclusively, to a cerebral aortic protection device. The present disclosure further describes methods of using the device.

Relevant prior art in this context, is U. Patent Application <CIT> which describes devices, methods, and systems which provide an embolism deflecting device, methods for deflecting or diverting emboli away from critical locations in the body, and systems therefor. <CIT> discloses an aortic protection device.

The invention relates to an aortic protection device according to the appended claims.

According to an aspect of some example embodiments, a device is designed for insertion to an aorta, to block debris in blood from flowing to arteries.

According to an aspect of some example embodiments, a device is designed for insertion to an aorta, capable of a controlled changing of porosity of a filter filtering blood flowing to arteries.

According to an aspect of some example embodiments, a device is designed for insertion to an aorta, to protect aorta walls from tools passing along the aorta.

According to the present invention there is provided an aortic protection device including a mesh lumen shaped and sized to extend along the aorta, from a heart-side of a brachiocephalic artery exit from the aorta to distal of a left subclavian artery exit from the aorta, wherein the mesh lumen is arranged to change a porosity of mesh pores in response to external control.

The term "mesh" in all its grammatical forms is used throughout the present specification and claims to mean a porous surface, whether constructed as a surface which includes pores, or as a weave which produces a porous mesh or net.

According to some example embodiments the mesh lumen is arranged to change a porosity from pores sized in a range between <NUM> microns and <NUM> microns to pores sized in a range between <NUM> and <NUM> microns or a range between <NUM> and <NUM> microns.

According to some example embodiments, the mesh lumen includes a porous surface.

According to some example embodiments, the mesh lumen includes a woven lumen.

According to some example embodiments, an angle between a direction of a thread in an external side of the mesh lumen is configured to be less than <NUM> degrees from a direction of a longitudinal axis of the mesh lumen when the mesh lumen is deployed.

According to some embodiments of the invention, the device includes a first mesh lumen including shape-memory material and a second mesh lumen including flexible material co-axial with the first mesh lumen.

According to some embodiments of the invention, the first mesh lumen surrounds the second mesh lumen.

According to some embodiments of the invention, the second mesh lumen surrounds the first mesh lumen.

According to some embodiments of the invention, the first mesh lumen is attached to the second mesh lumen along most of a length of the first mesh lumen.

According to some embodiments of the invention, the first mesh lumen is not attached to the second mesh lumen along most of a length of the first mesh lumen.

According to some embodiments of the invention, the device includes a first mesh lumen including shape-memory material, a second mesh lumen including flexible material, and a third mesh lumen including flexible material, wherein the second mesh lumen and the third mesh lumen are co-axial with the first mesh lumen.

According to some embodiments of the invention, the first mesh lumen is attached to the third mesh lumen along most of a length of the first mesh lumen.

According to some embodiments of the invention, the first mesh lumen is not attached to the third mesh lumen along most of a length of the first mesh lumen.

According to some embodiments of the invention, a flexible material outside mesh lumen has a greater diameter than a shape memory inside mesh lumen, enabling the outside mesh lumen to extend into arteries branching off the aorta.

According to some embodiments of the invention, a flexible material inside mesh lumen is shaped to contract away from a shape memory outside mesh lumen, reducing pore size of the flexible material inside mesh lumen.

According to some embodiments of the invention, a flexible material inside mesh lumen is shaped to contract away from a shape memory outside mesh lumen, designed to increase flow rate with a smaller diameter of the flexible material inside mesh lumen.

According to some embodiments of the invention, the first mesh lumen is arranged to form an elongated shape with a horseshoe shaped cross section.

According to some embodiments of the invention, the shape memory material is a material selected from a group consisting of Nitinol, Nitinol alloy, stainless steel, DFT (Drawn Filled Tube) composite wire, cobalt chromium, polymer material such as polymer wire, polymer woven\braided material, a combination of more than one polymer, a medical grade metal coated with polymer, and polymer coated wire.

According to some embodiments of the invention, the flexible material is a material selected from a group consisting of polyurethane, carbonated polyurethane, a derivative of one of the above-mentioned materials, polymer, a mesh of polymer, polymer wire, woven polymer wire, polymer cable, and woven polymer cable.

In the context of the present disclosure, a method is described for protecting cerebral aorta from blood-borne debris during an aortic procedure, the method including inserting an aortic protection device including a first mesh lumen shaped and sized to extend along the aorta, from a heart-side of a brachiocephalic artery exit from the aorta to distal of a left subclavian artery exit from the aorta, inserting a surgical device for performing the aortic procedure, reducing porosity of the aortic protection device, and performing at least part of the aortic procedure.

According to an aspect of the present disclosure, the reducing porosity is performed by changing a porosity from pores sized in a range between <NUM> microns and <NUM> microns to pores sized in a range between <NUM> and <NUM> microns or a range between <NUM> and <NUM> microns.

According to the present disclosure, he reducing porosity of the device includes twisting a proximal end of the first mesh lumen relative to a distal end of the first mesh lumen, thereby changing a shape of the mesh pores of the first mesh lumen and reducing porosity of the device.

According to the present disclosure, the reducing porosity of the device includes deploying a second mesh lumen along at least a portion of the first mesh lumen, the second mesh lumen having smaller pores than the first mesh lumen.

According to the present disclosure, the reducing porosity of the device includes deploying a second mesh lumen along at least a portion of the first mesh lumen, the second mesh lumen having pores a same size as the first mesh lumen.

According to the present disclosure, the reducing porosity of the device includes rotating the second mesh lumen relative to the first mesh lumen.

According to the present disclosure, the reducing porosity of the device includes twisting a proximal end of the second mesh lumen relative to a distal end of the second mesh lumen, thereby changing a shape of the mesh pores of the second mesh lumen and reducing porosity of the device.

According to the present disclosure, inserting the device includes inserting the device including both the first mesh lumen and the second mesh lumen, wherein the second mesh lumen is packaged near a heart-side end of the first mesh lumen, and reducing porosity of the device includes un-packaging and deploying the second mesh lumen.

According to the present disclosure, the reducing porosity of the device includes reducing a diameter of the device in response to external control.

According to the present disclosure, the device includes a first mesh lumen including shape-memory material and a second mesh lumen including flexible material co-axial with the first mesh lumen, and the reducing the diameter of the device includes pulling out at least one wire included in the first mesh lumen.

According to the present disclosure, the reducing porosity of the device includes extending a length of the device along the aorta.

According to the present disclosure, the reducing porosity of the device includes reducing a length of the device along the aorta.

According to the present disclosure, the method further includes extracting the first mesh lumen in at least two stages, a first stage including pulling out at least one wire included in the first mesh lumen and a subsequent stage including pulling out a remainder of the wires included in the first mesh lumen.

According to the present disclosure, the method further includes extracting the first mesh lumen before extracting the second mesh lumen.

According to the present disclosure, the method further includes extracting the second mesh lumen before extracting the first mesh lumen.

According to the present disclosure, the aortic procedure includes a procedure selected from a group consisting of a trans-catheter aortic valve implantation (TAVI), a trans-catheter aortic valve replacement (TAVR), and a percutaneous aortic valve replacement (PAVR).

According to the present disclosure a method is described for protecting cerebral aorta from blood-borne debris during an aortic valve procedure, the method including inserting a device including a first mesh lumen including shape-memory material and a second mesh lumen including flexible material co-axial with the first mesh lumen, both of the mesh lumens shaped and sized to extend along the aorta, from a heart-side of a brachiocephalic artery exit from the aorta to distal of a left subclavian artery exit from the aorta, inserting a surgical device for performing the aortic valve procedure, and performing at least part of the aortic procedure, wherein the second mesh lumen is not attached to the first mesh lumen at least along entrances to a brachiocephalic artery, a left common carotid artery and a left subclavian artery.

According to the present disclosurea method is described of manufacturing an aortic protection device including producing a mesh lumen shaped and sized to extend along the aorta, from a heart-side of a brachiocephalic artery exit from the aorta to distal of a left subclavian artery exit from the aorta, wherein the mesh lumen is arranged to change a porosity of mesh pores in response to external control.

According to the present disclosure, the mesh lumen is produced of a material selected from a group consisting of a polyurethane material, a carbonated polyurethane material, and a derivative of one of the above-mentioned materials.

According to the present disclosure, the mesh lumen includes a porous surface.

According to the present disclosure, the mesh lumen includes a woven lumen.

According to the present disclosure, the method further includes producing the woven lumen by weaving the woven lumen.

According to the present disclosure, an angle between a direction of a thread in an external side of the mesh lumen is configured to be less than <NUM> degrees from a direction of a longitudinal axis of the mesh lumen when the mesh lumen is deployed.

According to the present disclosure, the producing the device includes producing a first mesh lumen including shape-memory material and a second mesh lumen including flexible material co-axial with the first mesh lumen.

According to the present disclosure, the device is produced so that the first mesh lumen surrounds the second mesh lumen.

According to the present disclosure, the device is produced so that the second mesh lumen surrounds the first mesh lumen.

According to the present disclosure, the device is produced to include a first mesh lumen including shape-memory material, a second mesh lumen including flexible material, and a third mesh lumen including flexible material, wherein the second mesh lumen and the third mesh lumen are co-axial with the first mesh lumen.

According to the present disclosure, the device is produced so that the first mesh lumen is attached to the third mesh lumen along most of a length of the first mesh lumen.

According to the present disclosure, the device is produced so that the first mesh lumen is not attached to the third mesh lumen along most of a length of the first mesh lumen.

According to the present disclosure, the shape memory material is a material selected from a group consisting of Nitinol, Nitinol alloy, stainless steel, DFT (Drawn Filled Tube) composite wire, cobalt chromium, polymer material such as polymer wire, polymer woven\braided material, a combination of more than one polymer, a medical grade metal coated with polymer, and polymer coated wire.

According to the present disclosure, the flexible material is a material selected from a group consisting of polyurethane, carbonated polyurethane, a derivative of one of the above-mentioned materials, polymer, a mesh of polymer, polymer wire, woven polymer wire, polymer cable, and woven polymer cable.

According to the present disclosure, the flexible material is produced by a production process selected from a group consisting of polymer injection, dipping a cylindrical shape in polymer, overcoating a cylindrical shape or sleeve in polymer, electro-spinning a polymer thread, and weaving polymer threads.

The present invention, in some embodiments thereof, relates to a device that is configured to be inserted into an aorta, and, more particularly, but not exclusively, to a cerebral aortic protection device.

The invention includes a device which includes a mesh lumen which is arranged to change porosity through lumen walls.

In some embodiments, the device includes a mesh lumen which changes its porosity in response to being twisted.

In some embodiments, the device includes two layers of mesh, and porosity through the two layers changes in response to a first mesh layer shifting and/or twisting relative to a second mesh layer.

In some embodiments, the device includes a first layer of mesh with a first porosity through the first layer, and a second layer of mesh deployable to lie parallel and/or concentric to the first layer, the two layers together optionally having a different porosity than the first layer alone.

In some embodiments the device is arranged to be inserted and deployed in an aorta with the second mesh layer furled and/or folded such that the second mesh extends along a small portion, for example less than half, of the first mesh lumen is covered by the second mesh. In some embodiments the second mesh lumen is optionally unfurled and/or unfolded within an aorta and deployed to lie parallel to the first mesh lumen, optionally along a significant portion of a length of the first mesh lumen, optionally along an entire length of the first mesh lumen.

In some embodiments, the device includes a first layer of mesh with a first porosity, and a second mesh layer lumen of shape memory wires deployable to lie parallel and/or concentric to the first layer. In some embodiments at least one of the wires of the second layer are arranged to be optionally pulled out of at least a portion of the second mesh layer, optionally enabling a partial collapse of the second mesh layer, optionally enabling the first mesh layer to contract and change porosity of the first mesh layer.

In some embodiments, the device includes a mechanism for changing a length of at least a first layer of mesh with a first porosity, optionally stretching the first layer, optionally changing the porosity of the first layer. In some embodiments, the device includes a mechanism for changing a length of at least a first layer of mesh with a first porosity, optionally contracting a length of the first layer, optionally changing the porosity of the first layer.

In some embodiments, the device includes three layers of mesh. In some embodiments the layers include a first, outer layer, a second middle layer, and a third, inner layer.

In some embodiments, the device includes two layers. In some embodiments the layers include a first, outer layer, and a second inner layer including shape memory wires.

In some embodiments, the device includes two layers. In some embodiments the layers include a first, outer layer including shape memory wires, and a second inner layer.

In some embodiments, the shape memory layer optionally gives a deployed device a shape of a lumen, optionally corresponding to an inside of an aorta.

In some embodiments, an outer layer of the device is flexible. In some embodiments, when the device is deployed in an aorta, blood pressure optionally pushes an outer mesh layer into artery openings in a wall of the aorta.

In some embodiments, an inner layer of the device is flexible. In some embodiments, when the device is deployed in an aorta, blood flow through the inner layer optionally lowers pressure within the inner layer, optionally causing the inner layer to contract. In some embodiments the inner layer optionally changes porosity due to the contracting. In some embodiments the inner layer contracting and forming a narrower lumen increases blood flow rate through the device, potentially clearing blood debris from the inside of the lumen.

The present disclosure includes a description of inserting a device which includes a mesh lumen which is arranged to change porosity into an aorta, deploying the device, and changing the porosity of the mesh lumen when the device is within the aorta.

According to the present disclosure, changing the porosity includes twisting a first portion of the mesh lumen relative to a second portion of the mesh lumen. In some embodiments the twisting is performed by twisting a first wire connected to the first portion of the mesh a different amount and/or a different direction than a second wire connected to the second portion of the mesh.

According to the present disclosure, the device includes two layers of mesh, and changing the porosity through the two layers includes shifting and/or twisting a first mesh layer relative to a second mesh layer.

According to the present disclosure, the device includes two layers of mesh. A first layer of mesh is initially deployed, and changing the porosity includes deploying the second layer of mesh to lie parallel and/or concentric to the first layer of mesh.

According to the present disclosure, the device includes a first layer of mesh with a first porosity, and a second mesh layer lumen of shape memory wires, in some embodiments, changing the porosity includes optionally pulling out at least a portion of the second mesh layer, optionally enabling a partial collapse of the second mesh layer, optionally enabling the first mesh layer to contract and change porosity of the first mesh layer.

According to the present disclosure, the device includes two layers of mesh. In some embodiments, changing porosity includes changing a length of at least a first layer of mesh, optionally stretching the first layer, optionally changing the porosity of the first layer.

According to the present disclosure, the method includes extracting a device which includes a mesh lumen from an aorta.

According to the present disclosure, the device is pulled into a catheter, and the catheter is extracted from the aorta and from the body.

According to the present disclosure, the catheter is inserted via a transfemoral route. In some embodiments the catheter is inserted via a radial route. In some embodiments the catheter is inserted through an open blood vessel during open heart surgery. In some embodiments catheters used for insertion have a diameter of, by way of a non-limiting example, <NUM>, <NUM>, and <NUM> French. In some embodiments the device includes lead wires from one end of the device - when the lead wires are pulled into a catheter, the device is pulled after the lead wires into the catheter, optionally furling into a small diameter suitable for entering the catheter.

The term "catheter" is used throughout the present specification and claims interchangeably with the term "sheath".

In some embodiments the device is pulled into a catheter in one stage and/or one pull, and the catheter is extracted from the aorta and from the body.

According to the present disclosure, the device is pulled into a catheter in more than one stage and/or more than one pull. In some stages the catheter includes a wire mesh, and some of the wires are pulled into a catheter at a first stage, and some of the wires are pulled into the catheter at a subsequent stage.

According to the present disclosure, the device includes a mesh on a downstream end of a mesh lumen. In some embodiments the mesh at the downstream end potentially traps debris flowing in the blood stream. In some embodiments when the device is pulled into a catheter for extraction, the debris is enveloped in the device, and the debris is pulled into the catheter with the device.

According to the present disclosure, the method includes inserting a device which includes two layers of mesh lumen to an aorta, and allowing an outer one of the two layers to be swept into artery openings in the aorta, to provide a mesh across the artery openings, potentially preventing debris from entering the arteries.

According to the present disclosure, the method includes inserting a device which includes a mesh lumen which is arranged to change porosity into an aorta, deploying the device in the aorta, and inserting tools for surgery on a heart through the device.

According to the present disclosure, the mesh lumen protects walls of the aorta from the tools. In some embodiments a material forming an inside of the device is made slippery, to aid insertion of the tools for surgery on the heart through the aorta.

For purposes of better understanding some embodiments of the present invention, reference is first made to <FIG>, which is a simplified line drawing illustration of a section of an aorta.

<FIG> shows a section of an aorta <NUM>. A first end <NUM> of the section of the aorta <NUM> is an end near the heart (not shown), and a second end <NUM> of the section of the aorta <NUM> is an end more distant from the heart. <FIG> shows an aortic arch, and second end <NUM> corresponds to a descending thoracic aorta.

The section of the aorta <NUM> is shown with exits to a few major arteries: a first, proximal-to-the-heart exit is to a brachiocephalic artery <NUM>; a second exit is to a left common carotid artery <NUM>; and a third exit is to a left subclavian artery <NUM>.

It is noted that the brachiocephalic artery <NUM> supplies blood to a right common carotid artery. The right and the left common carotid arteries supply blood to a brain. When an operation is performed on a heart, it happens that debris from the operation, by way of a non-limiting example calcium from a calcified heart valve, may detach from the heart and flow with the blood stream. If such debris flows to the brain, the debris may block an artery in the brain, as the arteries' diameter becomes smaller.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components set forth in the following description and/or illustrated in the drawings. Reference is now made to <FIG>, which is a simplified line drawing illustration of an aortic protection device, according to an example embodiment of the invention.

In some embodiments of the invention an aortic protection device <NUM> is inserted into the aorta. The device <NUM> optionally extends from near the first end <NUM> of the section of the aorta <NUM> shown in <FIG>, to the second end <NUM> of the section of the aorta <NUM> shown in <FIG>.

In some embodiments the device may optionally be sized and shaped to extend further down the descending thoracic aorta, and even along the abdominal aorta. Description of embodiments of the device and methods of using the device apply also to a longer device extending further, as can be understood by a person skilled in the art.

The device <NUM> includes a mesh <NUM>, in a shape of a lumen. The device <NUM> includes a heart-proximal ring <NUM>, at a heart-proximal end 15A of the mesh <NUM>.

In some embodiments the heart-proximal ring <NUM> optionally anchors the device <NUM> to the aorta, optionally preventing movement of the device along the aorta while other tools or catheter(s) (not shown) pass through the device <NUM>. In some embodiments the heart-proximal ring <NUM> optionally pushes against walls of the aorta in order to anchor the device <NUM> to the aorta.

In some embodiments one or more mesh layers are attached to the heart-proximal ring <NUM>.

In some embodiments the device <NUM> optionally includes a heart-distal ring <NUM>, at a heart-distal end 15B of the mesh <NUM>.

In some embodiments, the device <NUM> is sized and shaped to fit an inside of an aorta of a patient.

In some embodiments, the size of the device <NUM> is selected from a range of sizes, lengths and diameters of the device, to fit patients from small to large.

In some embodiments, a length of the aortic protection device <NUM> is in a range of <NUM> to <NUM> to <NUM> millimeters.

In some embodiments the device may optionally be sized and shaped to extend further down the descending thoracic aorta, and even along the abdominal aorta, and reach a length up to <NUM> millimeters.

In some embodiments the device may optionally be sized and shaped to have a diameter of <NUM> to <NUM> to <NUM> to <NUM> millimeters, optionally to correspond to a diameter of a patient's aorta.

<FIG>, as well as the others Figures in the present specification, are not necessarily drawn to an exact scale. By way of example, holes in the mesh <NUM> are not necessarily drawn to scale.

In some embodiments the device <NUM> includes a layer of wires including shape memory material, optionally giving the device <NUM> its shape, when deployed, and one or more layers of mesh with small pores, sized in a range from X to Y microns.

In some embodiments mesh hole sizes depend on how much the mesh is stretched, for example by a shape of the shape-memory material.

Some non-limiting examples of the layer of shape memory material include a mesh made from shape memory material, a mesh woven and/or braided from shape memory material, and shape memory wires placed parallel to additional layers in the device.

Some non-limiting example of shape memory material include: Nitinol; Nitinol alloy; stainless steel; DFT (Drawn Filled Tube) composite wire; cobalt chromium; polymer material such as polymer wire; polymer woven\braided material; a combination of more than one polymer; medical grade metal coated with polymer; optionally in a form of wires\tubes and/or in a braided or laser cut form; thin polymer strings of high strength and flexibility, similar to memory-shaped polymer materials.

In some embodiments a polymer mesh potentially protects the aortic wall and/or calcification of the aortic wall from damage which may be inflicted by stiffer material such as a metal or plastic wire in the device.

In some embodiments the polymer mesh protects the aortic wall by being a softer or more elastic material than the stiffer material.

In some embodiments the polymer mesh is made of a polyurethane material or a carbonated polyurethane material or a derivative of the above-mentioned materials. In some embodiments the derivative material has same traits and/or characteristics as the polyurethane material or the carbonated polyurethane material.

In some embodiments the polymer mesh is made by injection of the polymer.

In some embodiments the polymer mesh is made by dipping a cylindrical shape or sleeve in the polymer material.

In some embodiments the polymer mesh is made by overcoating a cylindrical shape or sleeve in the polymer material.

In some embodiments the polymer mesh is made by weaving a polymer thread produced by electro-spinning a polymer material. In some embodiments the thread is electro-spun to a diameter in a range between <NUM> microns and <NUM> micron. In some embodiments the thread is electro-spun to a diameter lower than <NUM> micron, down to <NUM> micron.

In some embodiments the polymer mesh is made by weaving polymer threads. In some embodiments the weaving is a directional weaving. In some embodiments the weaving is a non-directional weaving, or weaving in random directions.

In some embodiments the polymer mesh is made of a smooth material, potentially suitable for sliding along a wall of the aorta.

In some embodiments the polymer mesh is made of a slippery material, potentially suitable for sliding along a wall of the aorta.

In some embodiments the polymer mesh is made of a non-stick or nonadhesive material, potentially suitable for sliding along a wall of the aorta.

In some embodiments the polymer mesh protects the aortic wall by using a weave of the mesh which prevents the stiffer material from touching the aortic wall.

In some embodiments the polymer mesh protects the aortic wall by using a weave of the mesh which enables the mesh to slide along the aortic wall.

In some embodiments an angle between a thread direction of the external side of the mesh and a direction of a longitudinal axis of the mesh lumen when the mesh lumen is deployed is configured to be less than an angle of <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, or <NUM> degrees or other angles in that range.

In some embodiments the device <NUM> is optionally attached to the aortic wall.

In some embodiments the device <NUM> is optionally inserted into an aorta and then expanded to press against the aortic wall.

In some embodiments contact between the device <NUM> and the aortic wall is based on outward radial pressure of a polymer mesh in the heart-proximal ring <NUM> pressing onto the aortic wall. Such pressure potentially fixes the heart-proximal ring <NUM> so as not to slide along the aortic wall. The pressure potentially fixes the heart-proximal ring <NUM> and does not damage the aortic wall and/or potentially does not cause the aortic wall to release particles downstream.

In some embodiments, the heart-proximal ring <NUM> is optionally shrunk to a lower diameter before pulling the device <NUM> out of the aorta. In some embodiments the shrinking is optionally performed by removing some wires, such as the Nitinol wires described below, from the heart-proximal ring <NUM>. In some embodiments the shrinking is optionally performed by reducing the outward radial force on the wall of the aorta. In some embodiments the shape and/or outward pressure of the heart-proximal ring <NUM> is optionally controlled by one or more wires such as a trigger wire and/or a first wire <NUM> and/or connecting wires 218A 218B descried below with reference to <FIG>.

In some embodiments, the heart-proximal ring <NUM> is optionally the first portion of the device <NUM> to be pulled out of the aorta.

In some embodiments, the heart-proximal ring <NUM> is optionally the first portion of the device <NUM> to be pulled into a catheter for extracting the device <NUM> from the aorta.

In some embodiments the heart-proximal ring <NUM> and/or the device <NUM> optionally include Nitinol wires. In some embodiments the Nitinol wires are pulled out of the aorta and/or into a catheter for extraction before a polymer mesh portion of the device <NUM> is pulled out of the aorta and/or into a catheter for extraction.

In some embodiments the device <NUM> is optionally pulled out of the aorta and/or a patient's body without shrinking into a catheter.

In some embodiments the device <NUM> is optionally compressed into a catheter such as an introducing catheter for removing from the patient's body.

In some embodiments, wires such as Nitinol wires are optionally taken out of the device <NUM>, and then the rest of the device <NUM> is optionally pulled out of the aorta and/or the patient's body, and/or compressed into a catheter such as an introducing catheter for removing from the patient's body.

Reference is now made to <FIG>, which is a simplified line drawing illustration of an example embodiment of the invention.

<FIG> shows a device <NUM> including a mesh <NUM>, an heart-proximal ring <NUM> at a heart-proximal end of the mesh <NUM>, and the device connected to a first wire <NUM>. A heart-distal end <NUM> of the mesh <NUM> is optionally connected to the first wire <NUM> by connecting wires 218A 218B.

The mesh <NUM> is shown deployed, expanded to an inner diameter of an aorta (not shown), with a catheter <NUM> near the heart-distal end <NUM> of the mesh <NUM>. The connecting wires 218A 218B spread out from the first wire <NUM> to the heart-distal end <NUM> of the mesh <NUM>.

In some embodiments the heart-proximal ring <NUM> optionally anchors the device <NUM> to the aorta, optionally preventing movement of the device along the aorta while other tools or catheter(s) (not shown) pass through the device <NUM>. In some embodiments the heart-proximal ring <NUM> optionally pushes against walls of the aorta in order to anchor the device <NUM> to the aorta,.

In some embodiments the connecting wires 218A 218B are arranged to potentially assist in withdrawing the mesh <NUM> back into the catheter <NUM>. The potential assistance in withdrawing is provided by the connecting wires attached to the first wire <NUM> so that when the first wire <NUM> is pulled back relative to the catheter <NUM> the connecting wires 218A 218B pull edges of the mesh <NUM> to which they are connected into the catheter <NUM>.

<FIG> shows a first circled portion 211A which shows the mesh <NUM>, connecting wires 218A 218B and the first wire <NUM>, in a drawing where the mesh <NUM> is deployed outside the catheter <NUM>.

<FIG> shows a second circled portion 211B which shows the mesh <NUM>, connecting wires 218A 218B and the first wire <NUM>, in a drawing where the mesh <NUM> is partly inside the catheter <NUM>.

In some embodiments anchoring of the device <NUM> to the aortic wall is optionally based on outward radial pressure of a polymer mesh in the heart-proximal ring <NUM> pressing onto the aortic wall. Such pressure potentially fixes the heart-proximal ring <NUM> so as not to slide along the aortic wall. The pressure potentially fixes the heart-proximal ring <NUM> and does not damage the aortic wall and/or potentially does not cause the aortic wall to release particles downstream.

In some embodiments, the heart-proximal ring <NUM> is optionally shrunk to a lower diameter before pulling the device <NUM> out of the aorta. In some embodiments the shrinking is optionally performed by removing one or more wires, for example a wire <NUM>, for example made of material such as the Nitinol wires described below, from the heart-proximal ring <NUM>. In some embodiments the shrinking is optionally performed by reducing the outward radial force on the wall of the aorta. In some embodiments the shape and/or outward pressure of the heart-proximal ring <NUM> is optionally controlled by one or more wires such as a trigger wire and/or the first wire <NUM> and/or the connecting wires 218A 218B. In some embodiments the heart-proximal ring <NUM> collapses to a conical shape or a cylindrical shape.

In some embodiments the heart-proximal ring <NUM> is collapsed, and the heart-proximal ring <NUM> is optionally pulled by the first wire <NUM>, turning the device <NUM> inside-out, pulling the heart-proximal ring <NUM> toward the catheter <NUM>.

In some embodiments, the heart-proximal ring <NUM> is optionally the first portion of the device <NUM> to be pulled into the catheter <NUM> for extracting the device <NUM> from the aorta.

In some embodiments the heart-proximal ring <NUM> and/or the device <NUM> optionally include Nitinol wires.

In some embodiments the Nitinol wires are pulled out of the aorta and/or into a catheter for extraction before a polymer mesh portion of the device <NUM> is pulled out of the aorta and/or into a catheter for extraction.

In some embodiments the shape and/or outward pressure of the heart-proximal ring <NUM> is optionally controlled by one or more wires such as a trigger wire and/or the first wire <NUM> and/or the connecting wires 218A 218B pulling out a wire such as the wire <NUM>, allowing the ring <NUM> to collapse inward, reducing the anchoring pressure.

In some embodiments the device <NUM> is optionally pulled out of the aorta and/or a patient's body without shrinking into a catheter such as the catheter <NUM> and/or an introducing catheter.

In some embodiments the device <NUM> is optionally compressed into a catheter such as the catheter <NUM> and/or an introducing catheter for removing from the patient's body.

In some embodiments, wires such as Nitinol wires are optionally taken out of the device <NUM>, and then the rest of the device <NUM> is optionally pulled out of the aorta and/or the patient's body, and/or compressed into a catheter such as the catheter <NUM> and/or an introducing catheter for removing from the patient's body.

In some embodiments the catheter <NUM> is optionally advanced toward the mesh <NUM>, and the mesh <NUM> optionally compressed into the catheter <NUM>, optionally for removing from the patient's body, potentially preventing possible damage to the aortic wall.

Reference is now made to <FIG>, which is a simplified line drawing illustration of a device deployed within an aorta according to an example embodiment of the invention.

<FIG> shows a section of an aorta, the section extending from a heart-proximal side <NUM> to a heart-distal side <NUM>, and includes the aortic arch.

<FIG> shows a device <NUM> in the aorta. The device includes a mesh <NUM> in the aortic arch, and two optional wires <NUM><NUM> attached to the mesh <NUM>. The mesh covers artery exits to the brachiocephalic artery <NUM>, the left common carotid artery <NUM> and the left subclavian artery <NUM>.

The mesh <NUM> potentially blocks debris flowing with blood in the aorta from entering the above-mentioned arteries.

It is noted that in some embodiments the mesh <NUM> may optionally extend more or less than shown in <FIG>. By way of a non-limiting example the mesh <NUM> may extend much further on a heart-distal side of aorta, covering more artery exits from the aorta.

In some embodiments the mesh includes pores of approximately <NUM> microns in diameter.

In some embodiments the mesh <NUM> is optionally controlled to change its porosity, for example from approximately <NUM> microns in diameter to a smaller size, providing better protection from debris entering the side arteries.

In some embodiments the mesh <NUM> is optionally controlled to change its porosity and to completely block blood from entering the side arteries.

In some embodiments the mesh <NUM> is optionally controlled to change its porosity for a limited amount of time, for example for a few seconds, for example <NUM> seconds, <NUM> seconds, <NUM> seconds, <NUM> seconds, up to a few minutes, for example two, three, four or five minutes.

In some embodiments the mesh <NUM> is optionally controlled to change its porosity and to completely block blood from entering the side arteries for a limited amount of time, for example for a few seconds, for example <NUM> seconds, <NUM> seconds, <NUM> seconds, <NUM> seconds, up to a few minutes, for example two, three, four or five minutes.

It is noted that in some cases, when the device <NUM> is inserted into the aorta, a heart-proximal end <NUM> of the device <NUM> may not be positioned around a circumference of the aorta, and may not prevent blood from flowing around the device <NUM>, between the mesh <NUM> and walls of the aorta.

<FIG> shows two non-limiting examples of the heart-proximal end <NUM> of the device <NUM> initially in positions <NUM><NUM> which do not prevent blood from flowing around the device <NUM>.

In some embodiments one or more optional wires, such as one or more of the optional wires <NUM><NUM>, is optionally used to remotely manipulated the heart-proximal end <NUM> of the device <NUM> to become properly positioned around a circumference of the aorta, as is shown in the position drawn in <FIG> for the heart-proximal end <NUM> of the device <NUM>.

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for protecting side arteries blood-borne debris according to an example embodiment of the invention.

In some embodiments the first mesh lumen is shaped and sized to extend along the aorta, from a heart-side of a brachiocephalic artery exit from the aorta to distal of a left subclavian artery exit from the aorta.

In some embodiments the changing porosity is reducing porosity.

Reference is now made to <FIG>, which is a simplified illustration of a device for measuring blood flow to a patient's head according to an example embodiment of the invention.

In some embodiments, blood flow to a patient's head is affected, by inserting an embodiment of an aortic protection device, and/or by optionally changing porosity of a mesh in the aortic protection device, and/or by optionally performing suction on blood flowing through the patient's aorta and optionally removing the blood from the patient's body.

In some embodiments blood flow to the patient's head is optionally monitored.

<FIG> shows a blood flow sensor <NUM> attached to a patient's head <NUM>.

In some embodiments the blood flow sensor <NUM> optionally sends <NUM> blood flow data to a blood flow display.

In some embodiments the blood flow sensor <NUM> optionally includes a blood flow display.

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for protecting cerebral aorta from blood-borne debris during an aortic procedure according to an example embodiment of the invention.

In some embodiments reducing the porosity involves decreasing pore size to increase protection of blood flow into side arteries, filtering out even smaller debris from the side arteries, and/or increasing resistance to blood flow to the side arteries.

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for protecting side arteries from blood-borne debris according to an example embodiment of the invention.

<FIG> describes an example embodiment and some optional changes in greater detail.

Optionally using a sheath to insert a pigtail toward the aortic valve (<NUM>).

Inserting tools for heart operation (<NUM>), in some embodiments optionally through a lumen of the aortic protection device.

Optionally changing porosity of the aortic protection device (<NUM>). In some embodiments changing the porosity involves decreasing pore size to increase protection of blood flow into side arteries, filtering out even smaller debris from the side arteries, and/or increasing resistance to blood flow to the side arteries.

Optionally performing the planned heart operation (<NUM>), by way of a non-limiting example TAVI.

Optionally, performing suction while the heart operation is performed (<NUM>).

Optionally changing porosity of the aortic protection device (<NUM>). In some embodiments changing the porosity after a heart operation may involve increasing pore size to increase blood flow into side arteries, or to cease blocking blood from the side arteries.

Optionally extracting the pigtail (<NUM>).

Extracting the aortic protection device (<NUM>).

In some embodiments the guide wire is optionally inserted through a leg which is opposite a leg planned to be used for a heart operation such as, by way of a non-limiting example, trans-catheter aortic valve implantation (TAVI).

In some embodiments the guide wire serves to guide an aortic protection device sheath, optionally an aortic protection device sheath having a diameter of <NUM> French. In some embodiments the aortic protection device sheath has a diameter in a range of <NUM> French to <NUM> French to <NUM> French.

In some embodiments the aortic protection device sheath is inserted to approximately <NUM> centimeters away from the aortic valve. In some embodiments the aortic protection device sheath is inserted to a distance approximately in a range of <NUM>-<NUM> centimeters away from the aortic valve.

In some embodiments inserting the aortic protection device is performed through the aortic protection device sheath.

In some embodiments the inserting the pig tail is performed by inserting a pig tail sheath through the aortic protection device sheath. In some embodiments the inserting the pig tail is intended to include any other tool/guide wire\tube that is inserted for use in a heart procedure.

In some embodiments changing the porosity of the aortic protection device is performed before, optionally just before, optionally a second or a few seconds before, performing the planned heart operation.

In some embodiments changing the porosity is changing from pores sized approximately <NUM> microns to <NUM> microns to pores sized approximately <NUM> to <NUM> microns.

In some embodiments providing suction to draw blood down the aorta is optionally performed while the heart operation is performed, or even extending after the heart operation is performed, in order to potentially draw blood with debris faster down the aorta, even draw the blood all the way out of the body. In some embodiments the suction is performed through a catheter which is left in the aorta during performance of a heart operation. In some embodiments the suction is performed through a catheter having a diameter of <NUM>, <NUM>, <NUM> or <NUM> French.

In some embodiments approximately <NUM>, <NUM>, <NUM> or <NUM> cubic centimeters of blood are drawn out of a patient's body during the suction.

In some embodiments changing the porosity after the heart operation is optionally changing from pores sized approximately <NUM> microns to pores sized approximately <NUM> microns.

Optionally inserting a pigtail toward the aortic valve (<NUM>).

Optionally inserting tools for heart operation (<NUM>), in some embodiments optionally through a lumen of the aortic protection device.

Changing porosity of the aortic protection device (<NUM>). In some embodiments changing the porosity involves decreasing pore size to increase protection of blood flow into side arteries, filtering out even smaller debris from the side arteries, and/or increasing resistance to blood flow to the side arteries.

Optionally, performing suction during a period when the heart operation is performed (<NUM>).

Optionally, partially retracting the aortic protection device (<NUM>) to potentially allow free blood flow to side arteries such as cerebral arteries.

In some embodiments the guide wire is optionally inserted to approximately <NUM> centimeters away from the aortic valve. In some embodiments, the guide wire is optionally inserted to a distance in a range, by way of a non-limiting example, of <NUM>-<NUM> centimeters away from the aortic valve.

In some embodiments inserting the guide wire is performed through an aortic protection device sheath, optionally an aortic protection device sheath having a diameter in a range of <NUM>-<NUM> French.

In some embodiments the inserting the pig tail is performed by inserting a pig tail sheath through the aortic protection device sheath.

In some embodiments changing the porosity is changing from pores sized approximately <NUM> microns to pores sized approximately <NUM>-<NUM> microns. In some embodiments changing the porosity is changing from pores sized in a range of <NUM> to <NUM> microns to pores sized in a range of <NUM> to <NUM> microns.

In some embodiments providing suction to draw blood down the aorta is optionally performed while the heart operation is performed, or even extending after the heart operation is performed, in order to potentially draw blood with debris faster down the aorta, even draw the blood all the way out of the body.

In some embodiments <NUM>-<NUM> cubic centimeters of blood are drawn out of a patient's body during the suction.

In some embodiments the suction is performed between an inner layer and an outer layer of the aortic protection device.

Reference is now made to <FIG>, which are simplified line drawings illustrations of a mesh changing porosity according to an example embodiment of the invention.

<FIG> shows a mesh <NUM> having a first porosity, and <FIG> shows the mesh <NUM> having a second porosity.

<FIG> shows the mesh <NUM> having larger pores <NUM> than pores <NUM> in the mesh <NUM> of <FIG>.

The change in size demonstrated by <FIG> is intended to show a qualitative change, and is not necessarily drawn to scale.

An example range of pore sizes includes initial large pores in a range of <NUM> to <NUM> micron size, and pores and/or meshes and/or aortic protection devices with a changed porosity in a range of <NUM> to <NUM> micron size.

Various devices and methods are described herein teaching how to change porosity of a mesh, and/or how to use more than one mesh over a same area to change porosity through the more-than-one meshes.

Reference is now made to <FIG>, which is a simplified illustration of an aortic protection device configured to change porosity according to an example embodiment of the invention.

<FIG> shows an aortic protection device <NUM> including at least one layer of mesh <NUM>.

<FIG> also shows a heart-proximal end <NUM> of the mesh <NUM> and a heart-distal end <NUM> of the mesh <NUM>.

In some embodiments one or both of the heart-proximal end <NUM> of the mesh <NUM> and the heart-distal end <NUM> of the mesh <NUM> optionally include a wire ring attached to the mesh.

In some embodiments the device <NUM> is optionally connected to one or more control wires.

<FIG> shows two control wires: a first control wire <NUM> and a second control wire <NUM>.

One method of changing porosity of a mesh is to twist the mesh.

<FIG> shows the mesh <NUM> where portions of the mesh <NUM> are twisted in different directions.

<FIG> shows, by way of a non-limiting example, a heart-proximal portion of the mesh <NUM> twisted toward a first direction <NUM>, a central portion of the mesh <NUM> twisted toward a, opposite, second direction <NUM>, and a heart-distal portion of the mesh <NUM> twisted toward a third direction <NUM>.

In some embodiments, a control wire such as the control wire <NUM> is optionally connected to the mesh <NUM> at a specific location. For example, the control wire <NUM> is shown, by way of a non-limiting example, attached to the heart-proximal end <NUM> of the mesh <NUM>. In some embodiments the control wire may optionally be attached to the above mentioned ring at the heart-proximal end <NUM> of the mesh <NUM>.

In some embodiments, a control wire such as the control wire <NUM> is optionally connected to the mesh <NUM> at a specific location. For example, the control wire <NUM> is shown, by way of a non-limiting example, attached to the central portion of the mesh <NUM>.

In some embodiments one or more of the control wire(s) <NUM><NUM> are optionally twisted in order to twist the mesh <NUM>. In some embodiments the one or more of the control wire(s) <NUM><NUM> are wires designed to transfer twist. In some embodiments the one or more of the control wire(s) <NUM><NUM> are woven wires, with the weaving pattern designed to transfer twist. In some embodiments the one or more of the control wire(s) <NUM><NUM> are solid, non-woven wires designed to transfer twist.

In some embodiments one or more of the control wire(s) <NUM><NUM> are optionally twisted in opposite direction. In some embodiments one or more of the control wire(s) <NUM><NUM> are optionally twisted in a same direction, by different amounts or angles.

In some embodiments twisting a mesh <NUM> deployed along an aorta warps a shape of the mesh pores, and the warping potentially changes an open area of the mesh pores.

In some embodiments the heart-proximal end <NUM> of the mesh <NUM> optionally expands against side walls of the aorta, potentially anchoring the heart-proximal end <NUM> of the mesh <NUM> against rotating with the aorta. In some embodiments a control wire attached to the heart-distal end <NUM> of the mesh <NUM> optionally serves to rotate the heart-distal end <NUM> of the mesh <NUM> relative to the heart-proximal end <NUM> of the mesh <NUM>, optionally changing porosity of the mesh <NUM>.

In some embodiments the heart-proximal end <NUM> of the mesh <NUM> includes an heart-proximal ring (not shown), at a heart-proximal end <NUM> of the mesh <NUM>, such as the heart-proximal ring <NUM> shown in <FIG>. In some embodiments the heart-proximal ring potentially anchors the heart-proximal end <NUM> of the mesh <NUM> against side walls of the aorta, potentially preventing rotation. In some embodiments a control wire attached to the heart-distal end <NUM> of the mesh <NUM> optionally serves to rotate the heart-distal end <NUM> of the mesh <NUM> relative to the heart-proximal end <NUM> of the mesh <NUM>, optionally changing porosity of the mesh <NUM>.

<FIG> shows a mesh <NUM> having a first porosity. The example embodiment of the mesh <NUM> of <FIG> is drawn as a non-warped shape of the mesh <NUM>.

<FIG> shows the mesh <NUM> warped, optionally by twisting, optionally compressed in a first direction, having a second, different porosity than the porosity of the mesh <NUM> of <FIG> shows the mesh <NUM> presenting smaller mesh pores than the mesh <NUM> shown in <FIG>.

<FIG> shows the mesh <NUM> warped, optionally by twisting, optionally compressed in a second direction, having a different porosity than the porosity of the mesh <NUM> of <FIG> and in some embodiments possibly different than the porosity of the mesh <NUM> of <FIG> shows the mesh <NUM> presenting smaller mesh pores than the mesh <NUM> shown in <FIG>.

In some embodiments the mesh <NUM> is warped, or the mesh <NUM> pore sizes are changed, by twisting the mesh <NUM>, optionally around its longitudinal axis. In some embodiments the mesh <NUM> is warped, or the mesh <NUM> pore sizes are changed, by changing a length of the mesh <NUM>, optionally by stretching the mesh <NUM>, optionally along its longitudinal axis. In some embodiments the mesh <NUM> is warped, or the mesh <NUM> pore sizes are changed, by changing a length of the mesh <NUM>, optionally by shortening or contracting or compressing the mesh <NUM>, optionally along its longitudinal axis.

In some embodiments deploying a device with two layers of mesh along an aorta provides example methods which change a porosity of the device.

<FIG> shows a mesh <NUM> presenting approximately square pores, and <FIG> show the square mesh holes deforming to a different shape, potentially able to block smaller debris than the pores shown on <FIG>. However, in various embodiments the mesh may have holes of other shapes, such as circular, oval, rectangular, rhomboid, and so on. Furthermore, asymmetric shapes may be used, such as, by way of a non-limiting example, shapes not having a mirror symmetry.

Reference is now made to <FIG>, which is a simplified line drawing illustration of aortic protection device according to an example embodiment of the invention.

<FIG> shows an aortic protection device <NUM> having two layers - an inner layer <NUM> and an outer layer <NUM>.

In some embodiments both the inner layer <NUM> and the outer layer <NUM> are mesh layers having multiple pores, which can potentially block blood-borne debris from passing through the mesh.

In some embodiments the inner layer <NUM> and the outer layer <NUM> optionally have pore sizes of <NUM> microns.

It is noted that wherever pore sizes are mentioned in the specification and claims, the pore size refers to an average diameter of a hole, whether the hole is shaped as a circle, a square, a rectangle, a rhomboid, or some irregular shape.

Reference is now made to <FIG>, which are simplified line drawings illustrations of two layers of mesh presenting different porosities at different times according to an example embodiment of the invention.

<FIG> shows a first mesh <NUM> and a second mesh <NUM> deployed one behind the other.

In the example embodiments of <FIG> the first mesh <NUM> and the second mesh <NUM> optionally have mesh pores of approximately a same size.

<FIG> illustrates that pores of a combination of the first mesh <NUM> and the second mesh <NUM> as shown in <FIG> are approximately aligned, <FIG> illustrates that a size of debris which would be blocked by the combination of the first mesh <NUM> and the second mesh <NUM> as shown in <FIG> is approximately similar to a size of debris which would be blocked by a single one of the first mesh <NUM> and the second mesh <NUM>.

<FIG> shows a first mesh <NUM> and a second mesh <NUM> deployed one behind the other, with the pore openings shifted and/or twisted relative to each other. By way of a non-limiting example the first mesh <NUM> and the second mesh <NUM> are shown with mesh lines and/or intersections in one of first mesh <NUM> and the second mesh <NUM> blocking mesh pores in the other one of the first mesh <NUM> and the second mesh <NUM>.

In some embodiments the first mesh <NUM> is shifted relative to the second mesh <NUM>. In some embodiments the first mesh <NUM> is rotated relative to the second mesh <NUM>. In some embodiments the first mesh <NUM> is twisted relative to the second mesh <NUM>.

The first mesh <NUM> and the second mesh <NUM> as deployed in <FIG> potentially present much greater blocking of debris, or much lesser porosity.

The two mesh layers deployed as shown in <FIG> can potentially serve to present porosity equivalent to a mesh layer with smaller mesh pores than either one of the first mesh <NUM> and the second mesh <NUM>.

Reference is now made to <FIG>, which are simplified line drawing illustrations of an aortic protection device according to an example embodiment of the invention.

<FIG> shows an aortic protection device <NUM> deployed in an aorta <NUM>, the aortic protection device <NUM> having two mesh layers - a first mesh layer <NUM> and a compactly packed second mesh layer <NUM>.

<FIG> also shows an ring <NUM> at a heart-proximal side of the aortic protection device <NUM>, a first control wire <NUM> attached to a heart-distal end of the device <NUM>, and a second control wire <NUM> attached to a heart-proximal end of the device <NUM> and/or to ring <NUM>.

<FIG> shows the aortic protection device <NUM> deployed, with the second mesh layer <NUM> folded or rolled or packaged near the heart-proximal end of the device <NUM>. In such deployment most of the aortic protection device <NUM> presents a single layer of mesh - the first mesh layer <NUM>. The aortic protection device <NUM> mostly presents a porosity of the first mesh layer <NUM>.

In some example embodiments the first mesh layer <NUM> has mesh pores of <NUM> microns.

<FIG> shows the second mesh layer <NUM> opened and extending along the first mesh layer <NUM>.

In some example embodiments the second mesh layer <NUM> has mesh pores of <NUM> microns.

<FIG> shows the second mesh layer <NUM> shorter than the first mesh layer <NUM>. However, <FIG> is not intended to limit the relative length of the two mesh layers. In some embodiments the second mesh layer <NUM> may be shorter than the first mesh layer <NUM>, equal in length to the first mesh layer <NUM>, or longer than the first mesh layer <NUM>.

<FIG> shows the second mesh layer <NUM> extending inside the first mesh layer <NUM> and not adjacent or touching the first mesh layer <NUM>. However, <FIG> is not intended to limit the relative diameter of the two mesh layers. In some embodiments the second mesh layer <NUM> may extend along and touch the first layer <NUM>, or the second mesh layer <NUM> may extend along the aorta and inside the first layer <NUM> yet not touching the first layer <NUM>.

In some embodiments the second mesh layer <NUM> is optionally shaped to have a larger diameter on a heart-proximal end, and a narrower diameter on a heart-distal end.

In some embodiments the device <NUM> is deployed before a start of a heart operation. The first mesh layer <NUM> extends along the aorta <NUM> and protects side arteries such as side arteries <NUM> from entry of debris, with a mesh pore size of the first mesh layer <NUM>.

In some embodiments such protection by the first mesh layer <NUM> optionally blocks larger pieces of debris, and allows blood flow to the side arteries against a resistance of the pores of the first mesh layer <NUM>.

In some embodiments the second mesh layer <NUM> is deployed before performing a heart operation, especially a heart operation which may potentially dislodge debris, such as TAVI. The second mesh layer provides better protection against debris, potentially blocking smaller pieces of debris, and allows blood flow to the side arteries against a larger resistance, of smaller pores of the second mesh layer <NUM>.

In some embodiments the second mesh layer <NUM> may potentially block blood flow to the side arteries <NUM>.

In some embodiments the second mesh layer is not a mesh layer with open pores, but a sheet of material, optionally shaped as a lumen, optionally made of flexible material.

Reference is now made to <FIG>, which is a simplified line drawing illustration of an aortic protection device according to an example embodiment of the invention.

<FIG> shows an aortic protection device <NUM> deployed in an aorta <NUM>, the aortic protection device <NUM> having two mesh layers - a first mesh layer <NUM> and a second mesh layer <NUM>.

In <FIG> the aorta is shown as straight. The description of <FIG> applies to both a straight section of the aorta <NUM>, for example the descending thoracic aorta and to a curved section of the aorta, such as the aortic arch.

<FIG> also shows an ring <NUM> at a heart-proximal side of the aortic protection device <NUM>, and a control wire <NUM> extending through a catheter <NUM> and attached to the second mesh layer <NUM>. In some embodiments the control wire <NUM> is attached to the upper ring <NUM>, and/or a lower ring (not shown) at a heart-distal end of the device <NUM>, and/or along a length of the first mesh layer <NUM>.

<FIG> also shows a side port <NUM> at an outside-the-body end of the catheter <NUM>, which enables passing the control wire <NUM> through the catheter <NUM> and enables performing suction through a side tube <NUM>. In some embodiments the side tube <NUM> also includes a valve <NUM> which controls passage from entrances <NUM><NUM> to the side tube <NUM>. In some embodiments one of the entrances <NUM><NUM> is optionally connected to low pressure for providing suction of blood though the catheter <NUM> when the valve <NUM> is optionally placed in a position which enables connection of suction to the side tube <NUM>.

In some embodiments the second mesh layer <NUM> is deployed by the control wire <NUM>, opened and extended along the first mesh layer <NUM>.

In some embodiments when the second mesh layer <NUM> is extended along the first layer <NUM>, the device presents a porosity approximately similar to the porosity of the second mesh layer <NUM>.

In some embodiments the second mesh layer <NUM> is deployed by the control wire <NUM>, which optionally releases a spring which extends the second mesh layer <NUM> along the first mesh layer <NUM>.

In some embodiments the device <NUM> is deployed before a start of a heart operation. The first mesh layer <NUM> extends along the aorta <NUM> and protects side arteries from entry of debris, with a mesh pore size of the first mesh layer <NUM>.

In some embodiments the second mesh layer <NUM> is deployed before performing a heart operation, especially a heart operation which may potentially dislodge debris, such as TAVI. The second mesh layer <NUM> optionally provides better protection against debris, potentially blocking smaller pieces of debris, and allows blood flow to the side arteries against a larger resistance, of smaller pores of the second mesh layer <NUM>.

In some embodiments the second mesh layer <NUM> may potentially block blood flow to the side arteries.

The method of <FIG> includes:
Inserting a guide wire to a location above the aortic valve (<NUM>).

Inserting an aortic protection device (<NUM>) which includes a first mesh layer.

Changing porosity of the aortic protection device (<NUM>). In some embodiments changing the porosity involves deploying a second mesh layer along or covering the first mesh layer.

In some embodiments changing the porosity is changing from pores in the first mesh sized approximately <NUM> microns to pores in the second, additional mesh sized approximately <NUM> microns.

In some embodiments suction is performed through a catheter opening placed near an exit from a lumen of the aortic protection device.

In some embodiments suction is performed through a catheter opening placed within a lumen of the aortic protection device.

In some embodiments the suction is performed between the second mesh layer and the first mesh layer of the aortic protection device.

<FIG> shows an aortic protection device <NUM> in a shape which the aortic protection device <NUM> assumed when deployed in an aortic arch (not shown), the aortic protection device <NUM> having two mesh layers - a first mesh layer <NUM> and a compressed second mesh layer <NUM> near a heart-proximal end <NUM> of the device <NUM>.

<FIG> shows a cross section of the aortic protection device <NUM> deployed, with the second mesh layer <NUM> deployed along the first mesh layer <NUM>.

In some embodiments the device <NUM> is deployed before a start of a heart operation. The first mesh layer <NUM> extends along the aorta and protects side arteries from entry of debris, with a mesh pore size of the first mesh layer <NUM>.

In some embodiments the second mesh layer <NUM> is deployed before performing a heart operation, especially a heart operation which may potentially dislodge debris, such as TAVI. The second mesh layer <NUM> provides better protection against debris, potentially blocking smaller pieces of debris, and allows blood flow to the side arteries against a larger resistance, of smaller pores of the second mesh layer <NUM>.

<FIG> shows a small area in a first mesh layer <NUM> deployed in an aorta (not shown).

<FIG> shows the small area in the first mesh layer <NUM> with the second mesh layer <NUM> also deployed. <FIG> illustrates that pores of a combination of the first mesh layer <NUM> and the second mesh layer <NUM> as shown in <FIG> present smaller holes/pores than the first mesh layer <NUM> alone.

Reference is now made to <FIG>, which are simplified line drawings illustrations of a mesh presenting different porosities at different times according to an example embodiment of the invention.

<FIG> shows a small area in a mesh <NUM>.

<FIG> shows the small area in the mesh <NUM>, marked with reference number 701a, where one or more wire(s) or thread(s) <NUM> from the mesh layer <NUM> of <FIG> have been pulled out of the mesh <NUM>, producing a mesh 701a presenting at least some holes or pores which are larger than the holes or pores of the mesh <NUM>.

<FIG> shows a small area in a mesh <NUM> deployed in an aorta (not shown). The mesh <NUM> is optionally made of a first set of wires or threads <NUM>, and a second set of wires or threads <NUM> passing and/or woven through the first set of wires or threads <NUM>. The mesh <NUM> presents a first pore size.

<FIG> shows the small area in the mesh <NUM>, marked with reference number 705a, where one or more of the second set of wire(s) or thread(s) <NUM> have been pulled out of the mesh <NUM>, producing the mesh 705a presenting at least some holes or pores which are larger than the holes or pores of the mesh <NUM>.

Reference is now made to <FIG>, which is a simplified line drawing illustration of an arterial protection device in an aorta according to an example embodiment of the invention.

<FIG> shows an example embodiment of an arterial protection device, including a mesh <NUM>, which blocks the exits to the arteries <NUM>, <NUM>, <NUM>.

The mesh <NUM> presents a first porosity for blocking blood-borne debris.

Reference is now made to <FIG>, which is a simplified line drawing illustration of the arterial protection device of <FIG>, according to an example embodiment of the invention.

<FIG> shows a mesh <NUM>, corresponding to the mesh <NUM> of <FIG>, after one or more wires have been extracted from the mesh <NUM>.

In some embodiments the mesh <NUM> contracts after one or more wires have been extracted, and the contraction makes the mesh <NUM> present smaller pores.

In some embodiments, the mesh <NUM> of <FIG> supports an elastic mesh (not shown) on an outside surface of the mesh <NUM>. In some embodiments, when the mesh <NUM> contracts to a form of the mesh <NUM> of <FIG>, the elastic mesh on the outside surface of the mesh <NUM> also contracts, and present smaller pores for blocking blood-borne debris.

In some embodiments the mesh <NUM> contracts after one or more longitudinal wires have been extracted, and the contraction makes the mesh <NUM> narrow toward a center of the aorta <NUM>.

Reference is now made to <FIG>, which is a simplified line drawing illustration of an arterial protection device according to an example embodiment of the invention.

<FIG> shows an arterial protection device <NUM> with a mesh including one or more permanent wires <NUM> and one or more additional wires <NUM> in between the permanent wires <NUM>.

In some embodiments, at least one of the additional wires <NUM> is pulled out of the mesh, leaving permanent wires <NUM>. In some embodiments the shape of the mesh changes in response to pulling out one or more of the additional wires <NUM>, causing a change in pore sizes of the mesh, and a change in porosity of the arterial protection device <NUM>.

In some embodiments the permanent wires <NUM> are arranged in a spiral along a length of the arterial protection device <NUM>, and when one or more additional wires <NUM> are pulled out of the mesh, the spiral permanent wires <NUM> cause a contraction of a length of the arterial protection device <NUM>, and a decrease in pore size in the mesh.

In some embodiments the arterial protection device <NUM> optionally includes a first ring <NUM> at one end of the arterial protection device <NUM> and optionally includes a second ring <NUM> at another end of the arterial protection device <NUM>.

In some embodiments the arterial protection device <NUM> contracts after one or more wires have been extracted, and the contraction makes the arterial protection device <NUM> present smaller pores.

In some embodiments, the arterial protection device <NUM> of <FIG> supports an elastic mesh (not shown) on an outside surface of the arterial protection device <NUM>. In some embodiments, when the arterial protection device <NUM> contracts, the elastic mesh on the outside surface of the arterial protection device <NUM> also contracts, and present smaller pores for blocking blood-borne debris.

In some embodiments the arterial protection device <NUM> contracts after one or more of the additional wires <NUM> have been extracted, and the contraction makes the arterial protection device <NUM> narrow toward a center of the aorta.

Reference is now made to <FIG>, which is a simplified line drawing illustration of a portion of a mesh in an arterial protection device according to an example embodiment of the invention.

<FIG> shows a mesh including one or more permanent wires <NUM> and one or more additional wires <NUM> in between the permanent wires <NUM>.

In some embodiments, at least one of the additional wires <NUM> is pulled out of the mesh <NUM>, leaving permanent wires <NUM>. In some embodiments the shape of the mesh <NUM> changes in response to pulling out one or more of the additional wires <NUM>, causing a change in pore sizes of the mesh <NUM>, and a change in porosity of the arterial protection device.

Reference is now made to <FIG>, which is a simplified line drawing illustration of the portion of the mesh of <FIG>, after at least one of the additional wires was pulled out of the mesh according to an example embodiment of the invention.

<FIG> shows the mesh <NUM> of <FIG> including one or more permanent wires <NUM> and one or more additional wires <NUM> in between the permanent wires <NUM>.

However, some of the additional wires <NUM> have been pulled out of the mesh <NUM>.

An aspect of some embodiments of the invention relates to an aortic protection device which includes more than one layer of mesh.

Properties of meshes described above with reference to embodiments of aortic protection devices are also included in some embodiments of the aortic protection device which include more than one layer of mesh.

Reference is now made to <FIG>, which is a simplified line drawing illustration of a portion of an aortic protection device having two mesh layers according to an example embodiment of the invention.

<FIG> shows a first, inner mesh <NUM> and a second, outer mesh <NUM>.

In some embodiments the inner mesh <NUM> includes shape memory material, and provides shape to the aortic protection device, optionally supporting the outer mesh <NUM> against the outer side of the inner mesh <NUM>. In some embodiments the inner mesh <NUM> includes shape memory material, and presses the outer mesh <NUM> against walls of an aorta.

In some embodiments the outer mesh <NUM> includes a flexible mesh material. In some embodiments the outer mesh <NUM> includes an elastic mesh material.

In some embodiments the outer mesh <NUM> includes a polymer material. In some embodiments the outer mesh <NUM> includes an elastic mesh material.

In some embodiments the outer mesh <NUM> includes a woven mesh material. In some embodiments the outer mesh <NUM> includes a woven polymer material. In some embodiments the outer mesh <NUM> includes a combination of metal mesh and polymer material optionally woven polymer material.

In some embodiments the outer mesh <NUM> is held stretched against the inner mesh <NUM>.

In some embodiments the outer mesh <NUM> is loose around the inner mesh <NUM>.

In some embodiments the inner mesh <NUM> is woven of wires and possesses properties such as the meshes described above with reference to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> and <FIG>.

In some embodiments the outer mesh <NUM> includes shape memory material, and provides shape to the aortic protection device.

In some embodiments the inner mesh <NUM> includes a flexible mesh material. In some embodiments the inner mesh <NUM> includes an elastic mesh material.

In some embodiments the inner mesh <NUM> includes a polymer material. In some embodiments the inner mesh <NUM> includes an elastic mesh material.

In some embodiments the inner mesh <NUM> includes a woven mesh material. In some embodiments the inner mesh <NUM> includes a woven polymer material. In some embodiments the inner mesh <NUM> includes a combination of metal mesh and polymer material optionally woven polymer material.

In some embodiments the inner mesh <NUM> is attached to the outer mesh <NUM>.

In some embodiments the inner mesh <NUM> is loose inside the outer mesh <NUM>.

In some embodiments the outer mesh <NUM> is woven of wires and possesses properties such as the meshes described above with reference to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> and <FIG>.

Reference is now made to <FIG>, which is a simplified line drawing illustration of a portion of an aortic protection device having three mesh layers according to an example embodiment of the invention.

<FIG> shows a first, inner mesh <NUM>, a second, middle mesh <NUM> and a third, outer mesh <NUM>.

In some embodiments the inner mesh <NUM> includes a flexible material such as described above with reference to the flexible material of outer mesh <NUM> of <FIG>.

In some embodiments the middle mesh <NUM> includes shape memory material such as described above with reference to the shape memory material of inner mesh <NUM> of <FIG>.

In some embodiments the outer mesh <NUM> includes a flexible material such as described above with reference to the flexible material of outer mesh <NUM> of <FIG>.

Reference is now made to <FIG>, which is a simplified line drawing illustration of an aortic protection device according to an example embodiment of the invention, located in an aorta.

<FIG> shows an aorta <NUM>, in which an aortic protection device <NUM> is deployed. The aortic protection device <NUM> includes a flexible mesh <NUM>, or a flexible outer mesh. Portions 903a 903b 903c of the flexible mesh <NUM> are optionally swept into aortic branches 902a 902b 902c. The portions 903a 903b 903c of the flexible mesh <NUM> optionally jut into the aortic branches 902a 902b 902c.

When the portions 903a 903b 903c of the flexible mesh <NUM> are optionally swept into aortic branches 902a 902b 902c, the portions potentially seal the entrances to the aortic branches 902a 902b 902c.

In some embodiments the aortic protection device <NUM> includes a flexible outer mesh <NUM> and an optional inner mesh <NUM>, as described above with reference to <FIG>.

In some embodiments the aortic protection device <NUM> includes three layers of mesh, as described above with reference to <FIG>.

The aortic protection device <NUM> includes an ring <NUM> at a heart-proximal side of the aortic protection device <NUM>. In some embodiments the ring <NUM> is expanded against walls of the aorta <NUM> optionally anchoring the aortic protection device <NUM> in the aorta. In some embodiments a length of the ring <NUM> is in a range of <NUM>-<NUM> centimeters.

In some embodiments the aortic protection device <NUM> optionally includes an optional ring <NUM> at a heart-distal side of the aortic protection device <NUM>. In some embodiments the optional ring <NUM> is expanded against walls of the aorta <NUM> optionally anchoring the aortic protection device <NUM> in the aorta. In some embodiments a length of the optional ring <NUM> is in a range of <NUM>-<NUM> centimeters.

In some embodiments the ring <NUM> at the heart-distal side of the aortic protection device <NUM> is optionally closed before retrieval of the aortic protection device <NUM>, potentially closing a downstream exit of the aortic protection device <NUM>, preventing debris from flowing downstream of the aortic protection device <NUM>.

In some embodiments the ring <NUM> at the heart-proximal side of the aortic protection device <NUM> is optionally closed before retrieval of the aortic protection device <NUM>, potentially closing an exit from the aortic protection device <NUM>, trapping debris inside the aortic protection device <NUM>, potentially enabling withdrawing the debris together with the aortic protection device <NUM> from a patient's body.

In some embodiments the aortic protection device <NUM> is optionally attached to a control wire <NUM> during deployment.

Reference is now made to <FIG>, which are simplified line drawing illustrations of an aortic protection device according to an example embodiment of the invention, located in an aorta.

<FIG> show how the aortic protection device is optionally used, in some embodiments, to speed up blood flow along the aorta, potentially sweeping away debris and potentially lowering a probability that the debris block an artery branching off the aorta.

<FIG> show an aorta <NUM>, in which an aortic protection device <NUM> is deployed. The aortic protection device <NUM> includes a flexible mesh <NUM>, or a flexible inner mesh <NUM>. <FIG> also show aortic branches <NUM>.

<FIG> shows the aortic protection device <NUM> with the flexible mesh <NUM> deployed along the walls of the aorta <NUM>.

In some embodiments deployment of the aortic protection device <NUM> as shown in <FIG> is performed before surgical operation on the heart or heart valve, such as TAVI, are performed, so before debris is potentially dislodged from the heart or heart valve.

<FIG> shows the flexible mesh <NUM> reshaped as a narrower lumen, for example as described above with reference to <FIG> and/or <FIG>. In some embodiments, when the flexible mesh <NUM> is reshaped as a narrower lumen, blood flows faster along the narrower lumen, potentially sweeping away debris and potentially lowering a probability that the debris block an artery branching off the aorta. In some embodiments, when the flexible mesh <NUM> is reshaped as a narrower lumen, mesh holes in the narrower lumen contract, we smaller, potentially blocking smaller pieces of debris from passing through the mesh. In some embodiments the flexible mesh <NUM> is reshaped as a narrower lumen just before and/or during a time when surgical operation on the heart or heart valve, such as TAVI, is performed, so as to potentially sweep away debris and potentially lower a probability that the debris block an artery branching off the aorta, and/or to block smaller pieces of debris from passing through the mesh <NUM>.

<FIG> also show a catheter <NUM> and a control wire <NUM>, optionally used for controlling the narrowing of the lumen of the flexible mesh <NUM>.

The aortic protection device <NUM> includes an ring <NUM> at a heart-proximal side of the aortic protection device <NUM>. In some embodiments the ring <NUM> is expanded against walls of the aorta <NUM> optionally anchoring the aortic protection device <NUM> in the aorta. In some embodiments the ring <NUM> remains expanded against walls of the aorta <NUM> even when the lumen of the flexible mesh <NUM> is made narrow, optionally anchoring the aortic protection device <NUM> in the aorta.

In some embodiments the aortic protection device <NUM> optionally includes an optional ring <NUM> at a heart-distal side of the aortic protection device <NUM>. In some embodiments the optional ring <NUM> is expanded against walls of the aorta <NUM> optionally anchoring the aortic protection device <NUM> in the aorta. In some embodiments the optional ring <NUM> remains expanded against walls of the aorta <NUM> even when the lumen of the flexible mesh <NUM> is made narrow, optionally anchoring the aortic protection device <NUM> in the aorta.

In some embodiments the aortic protection device <NUM> includes a flexible outer mesh and an additional inner mesh, as described above with reference to <FIG>.

<FIG> shows an aorta <NUM>, in which an aortic protection device <NUM> is deployed. The aortic protection device <NUM> includes a flexible mesh <NUM>. <FIG> also shows aortic branches <NUM>.

<FIG> will be used to describe example embodiments of a process of extracting the aortic protection device <NUM> after deployment and optionally after a heart operation such as TAVI.

First, some optional components of the aortic protection device <NUM> are described.

In some embodiments the aortic protection device <NUM> includes a flexible outer mesh <NUM> and an optional inner mesh, as described above with reference to <FIG>.

The aortic protection device <NUM> includes an ring <NUM> at a heart-proximal side of the aortic protection device <NUM>.

In some embodiments the aortic protection device <NUM> optionally includes an optional ring <NUM> at a heart-distal side of the aortic protection device <NUM>.

In some embodiments the aortic protection device <NUM> is optionally attached to a control wire <NUM> and a catheter <NUM> during deployment.

Next, a first example embodiment of a process for retrieval of the aortic protection device <NUM> is described.

In some embodiments the retrieval is optionally performed after heart surgery and/or TAVI and/or after the aortic protection device <NUM> has been placed in high filtration mode, with mesh pores of the aortic protection device <NUM> smaller than when initially deployed.

In some embodiments, the aortic protection device <NUM> is rotated so that an external wall of the aortic protection device <NUM> slides rotationally along walls of the aorta <NUM>. The rotation of the aortic protection device <NUM> relative to the walls of the aorta potentially reduces adhesion of the aortic protection device <NUM> to the walls of the aorta. Following the rotation the aortic protection device <NUM> is optionally pulled into the catheter <NUM> or into another catheter (not shown) specifically intended for retrieval of the aortic protection device <NUM>.

In some embodiments the aortic protection device <NUM> is rotated gradually, from a heart-proximal end to a heart-distal end. Such gradual rotation potentially encourages debris to move away from the heart-proximal end of the aortic protection device <NUM>.

In some embodiments shape memory wires <NUM> which are part of the aortic protection device <NUM> are optionally pulled out of the aortic protection device <NUM>, reducing pressure of the mesh against walls of the aorta, following which a rest of the aortic protection device <NUM> is pulled into a catheter for retrieving the aortic protection device <NUM>.

<FIG> shows an aorta <NUM>, in which an aortic protection device <NUM> is deployed. The aortic protection device <NUM> includes at least one mesh layer <NUM>. <FIG> also shows aortic branches <NUM>.

In some embodiments the aortic protection device <NUM> has a horseshoeshaped cross section, as can be seen at a heart-proximal end <NUM> of the aortic protection device <NUM> and at a heart-distal end <NUM> of the aortic protection device <NUM>. <FIG> shows a narrow open space <NUM> which defined the horseshoe cross section of the aortic protection device <NUM>.

In some embodiments the aortic protection device <NUM> includes a mesh coated with a porous polymer. In some embodiments the aortic protection device <NUM> includes a metal mesh coated with polymer, and/or a metal mesh coated with polymer with mesh holes.

In some embodiments the aortic protection device <NUM> includes two mesh layers <NUM>, <NUM>.

In some embodiments the aortic protection device <NUM> includes a flexible outer mesh <NUM> and an additional inner mesh <NUM>, as described above with reference to <FIG>.

In some embodiments the aortic protection device <NUM> is optionally attached to a control wire <NUM> and optionally a catheter (not shown) during deployment.

In some embodiments, the horseshoe shaped cross section of the aortic protection device <NUM> enables passing tools for operation on a heart side by side with a deployed aortic protection device <NUM>.

In some embodiments, the horseshoe shaped cross section of the aortic protection device <NUM> enables passing tools for operation on the heart, side by side with a deployed aortic protection device <NUM>, optionally of a diameter up to an entire diameter of an aorta.

<FIG> show an aorta <NUM> and aortic branches <NUM>.

<FIG> shows components of an aortic protection device <NUM>, including a shape memory material coil <NUM> deployed in the aorta <NUM> and a catheter <NUM> through which the coil <NUM> was optionally deployed.

The coil <NUM> includes a ring <NUM>, at a heart-proximal end of the coil <NUM>. In some embodiments the ring <NUM> is shaped and sized to expand against walls of the aorta <NUM>, optionally anchoring the coil <NUM> in the aorta <NUM>.

<FIG> shows a mesh <NUM>, also a component of the aortic protection device <NUM>, deployed surrounding the coil <NUM>.

In some embodiments the mesh <NUM> is optionally deployed through the catheter <NUM>.

Reference is now made to <FIG>, which is a simplified flow chart illustration of an example method of deploying the aortic protection device of <FIG>.

<FIG> describes a method for deploying the aortic protection device of <FIG>, including:.

In some embodiments, the mesh is deployed before an operation on a heart, such as a heart valve operation or a TAVI operation.

In some embodiments the coil is deployed in a compressed form, optionally through a catheter having a diameter of <NUM> to <NUM> French. In some embodiments the coil is deployed in a compressed form, optionally through a catheter having a diameter in a range of <NUM>-<NUM> French.

In some embodiments the mesh is deployed through a same catheter as the coil.

In some embodiments the coil is optionally retrieved through a second catheter having a diameter of <NUM> to <NUM> French.

In some embodiments the mesh is deployed through a same second catheter used for retrieving the coil.

Reference is now made to <FIG>, which is a simplified line drawing illustration of an aortic protection device and a catheter located in an aorta according to an example embodiment of the invention.

<FIG> shows an aorta <NUM>, in which an aortic protection device <NUM> and a catheter <NUM> are deployed. <FIG> also shows aortic branches <NUM>.

<FIG> also shows a side port <NUM> at an outside-the-body end of the catheter <NUM>, which enables passing a control wire <NUM> through the catheter <NUM> and also enables performing suction through a side tube <NUM>. In some embodiments the side tube <NUM> also includes a valve <NUM> which controls passage from entrances <NUM><NUM> to the side tube <NUM>.

In some embodiments one of the entrances <NUM><NUM> is optionally connected to low pressure for providing suction of blood though the catheter <NUM> when the valve <NUM> is in a position which enables connection of suction to the side tube <NUM>.

In some embodiments providing suction to draw blood down the aorta <NUM> is optionally performed while a heart operation is performed, or even extending after the heart operation is performed, in order to potentially draw blood with debris faster down the aorta, even draw the blood all the way out of the body.

In some embodiments the catheter <NUM> is placed near to a downstream end <NUM> of the aortic protection device <NUM>, as shown in <FIG>, in order to perform suction.

In some embodiments the catheter <NUM> is placed next to a downstream end <NUM> of the aortic protection device <NUM>, at a distance in a range of <NUM>-<NUM> millimeters away from the downstream end <NUM> of the aortic protection device <NUM>, in order to perform suction.

In some embodiments the catheter <NUM> is placed just inside (not shown) the downstream end <NUM> of the aortic protection device <NUM>, in order to perform suction.

In some embodiments the catheter <NUM> is placed a distance in a range of <NUM>-<NUM> millimeters inside (not shown) the downstream end <NUM> of the aortic protection device <NUM>, in order to perform suction.

The aortic protection device <NUM> includes a heart-proximal ring <NUM>, optionally anchoring the aortic protection device <NUM> to the aorta <NUM> walls.

The terms "comprising", "including", "having" and their conjugates mean "including but not limited to".

Claim 1:
An aortic protection device (<NUM>, <NUM>, <NUM>) comprising:
a heart-proximal ring (<NUM>,<NUM>,<NUM>); and
a mesh lumen (<NUM>, <NUM>) shaped and sized to extend along the aorta (<NUM>), from a heart-side of a brachiocephalic artery exit from the aorta to distal of a left subclavian artery exit from the aorta,
characterized by:
the mesh lumen (<NUM>, <NUM>) is arranged to change a porosity of mesh pores in response to external control,
and the heart-proximal ring (<NUM>,<NUM>,<NUM>) is attached to a heart-proximal end of the mesh lumen (<NUM>, <NUM>).