Device and method for embolic protection of aortic organs

Abstract

The invention relates to embolic protection devices and methods thereof, which are configured to be deployed before a medical intervention that might generate micro and / or macro emboly. The embolic protection devices comprise a capture element configured to provide embolic protection for the distal body of the patient. The embolic protection devices are configured to divert flow using a funnel-type flow diverter.

Description

[0001] DEVICE AND METHOD FOR EMBOLIC PROTECTION OF AORTIC ORGANS

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 714,257 filed on October 31, 2024 and of U.S. Provisional Patent Application No. 63 / 883,736 filed on September 18, 2025, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to devices and methods for embolic protection and, more particularly, but not exclusively, to devices and methods for renal and / or Superior Mesenteric Artery (SMA) embolic protection.

[0006] Endovascular procedures, for example, aortic procedures - aneurisms, repairs, and endovascular open surgeries (including trauma) involve known damage to the kidneys, gastrointestinal (GI) organs and abdomen\pelvic organs due to embolic particles (both macro-embolic and micro-embolic) - for example calcifications, plaque, blood clots, tissue particles, polymer particles - traveling into the organs and creating ischemic injury, fibrosis, necrosis, interstitial disease, organ failure and mortality.

[0007] Currently, there is no suitable solution for embolic protection to the celiac trunk and / or renal arteries and / or SMA.

[0008] Additionally, during endovascular procedures and, in some cases, also in open surgeries, the procedure include the use of contrast media that is delivered into the blood vessel proximal to treatment area, for imaging of the distal vessel area and / or the procedure area. Contrast media is known to cause Contrast Induced Nephropathy (CIN), which is the third most common cause of Acute Kidney Injury (AKI) and further complications morbidity and higher mortality probability. Latest studies regarding CIN show that this complication is reversible, and is dependent on the quantity and concentration of the contrast media exposed to the renal arteries. The Contrast media is further diluted in the blood body volume, and additional hydration ( 1>2 Liters of Saline) that are used as standard precaution.

[0009] SUMMARY OF THE INVENTION

[0010] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below. Example 1. An aortic embolic protection device comprising: a. an elongated selfexpandable body, comprising a proximal end and a distal end; said elongated self-expandable body sized and shaped to extend along an aorta; b. at least one element; c. at least one mechanism for controlling said at least one element.

[0011] Example 2. The aortic embolic protection device according to example 1, wherein said elongated self-expandable body comprises a frame and a mesh covering said frame.

[0012] Example 3. The aortic embolic protection device according to example 1 or example 2, wherein said mesh comprises pores having a size of from about 30 microns to 120 microns.

[0013] Example 4. The aortic embolic protection device according to any one of examples 1-3, wherein said mesh comprises different areas comprising pores of different sizes.

[0014] Example 5. The aortic embolic protection device according to any one of examples 1-4, wherein said mechanism extends from said aortic embolic protection device to an outside of a patient.

[0015] Example 6. The aortic embolic protection device according to any one of examples 1-5, wherein said at least one element is controlled from outside said patient.

[0016] Example 7. The aortic embolic protection device according to any one of examples 1-6, wherein said elongated self-expandable body comprises at least two configurations: a first undeployed configuration in which said elongated self-expandable body is sized and shaped to fit within a delivery catheter, and a second deployed configuration in which said elongated selfexpandable body is allowed to self-expand into the space into which is being delivered.

[0017] Example 8. The aortic embolic protection device according to any one of examples 1-7, wherein said at least one element is at least one ring positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body; said at least one ring characterized by having a higher radial force than said self-expandable mesh thereby configured to anchor said aortic embolic protection device in place.

[0018] Example 9. The aortic embolic protection device according to any one of examples 1-8, wherein said at least one element is at least one capture element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0019] Example 10. The aortic embolic protection device according to any one of examples 1-9, wherein said at least one capture element comprises an open configuration and a close configuration; wherein a movement between said open configuration, said close configuration and vice versa is performed by actuating said at least one mechanism.

[0020] Example 11. The aortic embolic protection device according to any one of examples 1-10, wherein said at least one element is at least one funnel-like element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body. Example 12. The aortic embolic protection device according to any one of examples 1-11, wherein said at least one funnel-like element comprises a deployed configuration and an undeployed configuration; wherein a movement between said deployed configuration, said undeployed configuration and vice versa is performed by actuating said at least one mechanism.

[0021] Example 13. The aortic embolic protection device according to any one of examples 1-12, wherein said at least one element is at least one narrowing element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0022] Example 14. The aortic embolic protection device according to any one of examples 1-13, wherein said at least one narrowing element comprises an actuated configuration and an unactuated configuration; wherein a movement between said actuated configuration, said unactuated configuration and vice versa is performed by actuating said at least one mechanism.

[0023] Example 15. The aortic embolic protection device according to any one of examples 1-14, wherein actuation of said at least one narrowing element causes a change in a porosity of said elongated self-expandable body.

[0024] Example 16. The aortic embolic protection device according to any one of examples 1-15, wherein said at least one element is at least one balloon element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0025] Example 17. The aortic embolic protection device according to any one of examples 1-16, wherein said at least one balloon element comprises an inflated configuration and a deflated configuration; wherein a passage between said inflated configuration, said deflated configuration and vice versa is performed by delivering inflation means through said at least one mechanism.

[0026] Example 18. The aortic embolic protection device according to any one of examples 1-17, wherein said at least one balloon element is configured to act as one or more of a capture element, a funnel-like element, a narrowing element and a blocking element.

[0027] Example 19. The aortic embolic protection device according to any one of examples 1-18, wherein said at least one element is at least one blocking element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0028] Example 20. The aortic embolic protection device according to any one of examples 1-19, wherein said at least one blocking element comprises an actuated configuration and an unactuated configuration; wherein a movement between said actuated configuration, said unactuated configuration and vice versa is performed by actuating said at least one mechanism.

[0029] Example 21. The aortic embolic protection device according to any one of examples 1-, wherein said elongated self-expandable body is one or more of a single body, a double mesh body, multi-layer mesh body, a multi-layer mesh having overlapped parts. Example 22. The aortic embolic protection device according to any one of examples 1-21, wherein said overlapped parts are configured to be extracted separately one from another.

[0030] Example 23. The aortic embolic protection device according to any one of examples 1-22, wherein said elongated self-expandable body extends from a heart-side of a celiac trunk to distal of a lowest lumbar artery.

[0031] Example 24. The aortic embolic protection device according to any one of examples 1-23, wherein said elongated self-expandable body is configured to cover one or more of the following side branches of said aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0032] Example 25. A method for providing aortic embolic protection to a patient during a medical procedure, comprising: a. positioning an aortic embolic protection device according to any one of examples 1-24; and b. actuating at least one element of said aortic embolic protection device during said medical procedure.

[0033] Example 26. The method according to example 25, further comprising repositioning said aortic embolic protection device if needed.

[0034] Example 27. The method according to example 25 or example 26, further comprising leaving said aortic embolic protection device in said patient after said medical procedure.

[0035] Example 28. The method according to any one of examples 25-27, further comprising removing said aortic embolic protection device from said patient after said medical procedure.

[0036] Example 29. The method according to any one of examples 25-28, wherein said positioning comprises positioning said elongated self-expandable body to extend from a heart-side of a celiac trunk to distal of a lowest lumbar artery.

[0037] Example 30. The method according to any one of examples 25-29, wherein said positioning comprises positioning said elongated self-expandable body to cover one or more of the following side branches of said aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0038] Example 31. An aortic embolic protection device for use in EVAR / TEVAR procedures, comprising: a. an elongated self-expandable body, comprising a proximal end and a distal end; said elongated self-expandable body sized and shaped to extend along an aorta; b. at least one element; c. at least one mechanism for controlling said at least one element; wherein said elongated self-expandable body is a multi-layer mesh having overlapped parts. Example 32. The aortic embolic protection device according to example 31, wherein each part of said multi-layer mesh comprises a frame and a mesh covering said frame.

[0039] Example 33. The aortic embolic protection device according to example 31 or example 32, wherein said mesh comprises pores having a size of from about 30 microns to 120 microns.

[0040] Example 34. The aortic embolic protection device according to any one of examples 31-33, wherein said mesh comprises different areas comprising pores of different sizes.

[0041] Example 35. The aortic embolic protection device according to any one of examples 31-34, wherein said mechanism extends from said aortic embolic protection device to an outside of a patient.

[0042] Example 36. The aortic embolic protection device according to any one of examples 31-35, wherein said at least one element is controlled from outside said patient.

[0043] Example 37. The aortic embolic protection device according to any one of examples 31-36, wherein said elongated self-expandable body comprises at least two configurations: a first undeployed configuration in which said elongated self-expandable body is sized and shaped to fit within a delivery catheter, and a second deployed configuration in which said elongated selfexpandable body is allowed to self-expand into the space into which is being delivered.

[0044] Example 38. The aortic embolic protection device according to any one of examples 31-37, wherein said at least one element is at least one ring positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body; said at least one ring characterized by having a higher radial force than said self-expandable mesh thereby configured to anchor said aortic embolic protection device in place.

[0045] Example 39. The aortic embolic protection device to any one of examples 31-38, wherein said at least one element is at least one capture element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0046] Example 40. The aortic embolic protection device according to any one of examples 31-39, wherein said at least one capture element comprises an open configuration and a close configuration; wherein a movement between said open configuration, said close configuration and vice versa is performed by actuating said at least one mechanism.

[0047] Example 41. The aortic embolic protection device according to any one of examples 31-40, wherein said at least one element is at least one funnel-like element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0048] Example 42. The aortic embolic protection device according to any one of examples 31-41, wherein said at least one funnel-like element comprises a deployed configuration and an undeployed configuration; wherein a movement between said deployed configuration, said undeployed configuration and vice versa is performed by actuating said at least one mechanism. Example 43. The aortic embolic protection device according to any one of examples 31-42, wherein said at least one element is at least one narrowing element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0049] Example 44. The aortic embolic protection device according to any one of examples 31-43, wherein said at least one narrowing element comprises an actuated configuration and an unactuated configuration; wherein a movement between said actuated configuration, said unactuated configuration and vice versa is performed by actuating said at least one mechanism.

[0050] Example 45. The aortic embolic protection device according to any one of examples 31-44, wherein actuation of said at least one narrowing element causes a change in a porosity of said elongated self-expandable body.

[0051] Example 46. The aortic embolic protection device according to any one of examples 31-45, wherein said at least one element is at least one balloon element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0052] Example 47. The aortic embolic protection device according to any one of examples 31-46, wherein said at least one balloon element comprises an inflated configuration and a deflated configuration; wherein a passage between said inflated configuration, said deflated configuration and vice versa is performed by delivering inflation means through said at least one mechanism.

[0053] Example 48. The aortic embolic protection device according to any one of examples 31-47, wherein said at least one balloon element is configured to act as one or more of a capture element, a funnel-like element, a narrowing element and a blocking element.

[0054] Example 49. The aortic embolic protection device according to any one of examples 31-48, wherein said at least one element is at least one blocking element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

[0055] Example 50. The aortic embolic protection device according to any one of examples 31-49, wherein said at least one blocking element comprises an actuated configuration and an unactuated configuration; wherein a movement between said actuated configuration, said unactuated configuration and vice versa is performed by actuating said at least one mechanism.

[0056] Example 51. The aortic embolic protection device according to any one of examples 31-50, wherein said elongated self-expandable body is one or more of a single body, a double mesh body, multi-layer mesh body.

[0057] Example 52. The aortic embolic protection device according to any one of examples 31-51, wherein said overlapped parts are configured to be extracted separately one from another. Example 53. The aortic embolic protection device according to any one of examples 31-52, wherein said elongated self-expandable body extends from a heart-side of a celiac trunk to distal of a lowest lumbar artery.

[0058] Example 54. The aortic embolic protection device according to any one of examples 31-55, wherein said elongated self-expandable body is configured to cover one or more of the following side branches of said aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0059] Example 55. A method for providing aortic embolic protection to a patient during a medical procedure, comprising: a. positioning an aortic embolic protection device according to any one of examples 31-54; and b. actuating at least one element of said aortic embolic protection device during said medical procedure.

[0060] Example 56. The method according to example 55, further comprising repositioning said aortic embolic protection device if needed.

[0061] Example 57. The method according to example 55 or example 56, further comprising leaving said aortic embolic protection device in said patient after said medical procedure.

[0062] Example 58. The method according to any one of examples 55-57, further comprising removing said aortic embolic protection device from said patient after said medical procedure.

[0063] Example 59. The method according to any one of examples 55-58, wherein said positioning comprises positioning said elongated self-expandable body to extend from a heart-side of a celiac trunk to distal of a lowest lumbar artery.

[0064] Example 60. The method according to any one of examples 55-59, wherein said positioning comprises positioning said elongated self-expandable body to cover one or more of the following side branches of said aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0065] 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. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0066] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0067] In the drawings:

[0068] Figures la-b are schematic representations of an exemplary embolic protection device, according to some embodiments of the invention;

[0069] Figures 2a-h are schematic representations of a capture element, according to some embodiments of the invention;

[0070] Figures 3a-c are schematic representations of a funnel-like element, according to some embodiments of the invention;

[0071] Figures 4a-b are schematic representations of an exemplary narrowing element, according to some embodiments of the invention;

[0072] Figures 5a-b are schematic representations of exemplary balloon elements, according to some embodiments of the invention;

[0073] Figures 6a-d are schematic representations of exemplary blocking elements, according to some embodiments of the invention;

[0074] Figures 7 a-b are schematic representation of exemplary devices comprising a plurality of elements, according to some embodiments of the invention;

[0075] Figures 8a-b are exemplary elongated bodies, according to some embodiments of the invention;

[0076] Figures 9a-b are schematic representations of the aorta branches;

[0077] Figures 10a- w are schematic representations of exemplary devices deployed in the aorta, according to some embodiments of the invention;

[0078] Figures l la-b are schematic representations of EVAR procedure;

[0079] Figures 12a-f are schematic representation of exemplary devices used during EVAR procedures;

[0080] Figure 13 is flowchart of an exemplary method, according to some embodiments of the invention; and

[0081] Figure 14 is flowchart of another exemplary method, according to some embodiments of the invention. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0082] The present invention, in some embodiments thereof, relates to devices and methods for embolic protection and, more particularly, but not exclusively, to devices and methods for renal and / or Superior Mesenteric Artery (SMA) embolic protection.

[0083] Overview

[0084] An aspect of some embodiments of the invention relates to embolic protection devices (and methods thereof), which are inserted percutaneously, for example via the contra lateral femoral access or from the femoral access, and are configured to be deployed before a medical intervention that might generate micro and / or macro emboly. In some embodiments, the devices are operated from outside of the body. In some embodiments, the devices are configured to provide a potentially complete and constant protection to the renal arteries, Celiac trunk and SMA. In some embodiments, the devices comprise a capture element configured to provide embolic protection for the distal body of the patient, comprising the abdomen, pelvic organs and limbs. In some embodiments, the devices are configured to divert flow using a funnel-type flow diverter. In some embodiments, the devices are configured to protect the kidneys from CIN contrast induced nephropathy by selectively blocking the flow. In some embodiments, the devices are configured to assist against heart failure (HF) by selectively limiting the blood flow. In some embodiments, the devices are positioned in the patient before the procedure and retrieved at the conclusion of the procedure. In some embodiments, optionally, the devices are configured to stay in the patient for long periods of time, after the procedure, for example 24 to 48 hours after the procedure (or longer). In some embodiments, optionally, part of the devices are configured to be detached from the main devices and stay in the patients after the procedure, and then, at the end of the desired time, the left devices are removed from the body. In some embodiments, the devices are configured to be repositioned within the patient during the procedure, either proximally or distally in relation to blood vessel. In some embodiments, repositioning comprises shrinking the device, repositioning it and re-expanding it - where the repositioning can be either higher or lower from the renal arteries level. In some embodiments, the devices comprise one or more features that can be used according to the needs and / or conditions of the patient. For example, the device can be used passively for general embolic protection to the renal arteries, Celiac trunk and SMA. In some embodiments, the device can be activated to additionally capture debris - for example for cases kidney diseases, high-stage aortic stenosis and / or any other background diseases. In some embodiments, the device can be further activated to divert the flow of blow away from the kidneys to prevent kidney damage from contrast material. In some embodiments, potential advantages of the device are potentially protecting renal arteries and / or celiac trunk and / or SMA from macro and / or micro embolic injuries, along and / or after the duration of medical procedures. In some embodiments, the devices comprise one or more elements, some configured to be actuated from outside the body of the patient by a wire. In some embodiments, one element comprises a tubular self-expandable body. In some embodiments, the body comprises a ring having a higher radial force configured to anchor the device in place. In some embodiments, the device is delivered by a catheter, pushed out the catheter and allowed to self-expand. In some embodiments, optionally, the tubular body is coated. In some embodiments, optionally, the tubular body comprises a filtering membrane of from about 30 microns to about 120 microns, for example 120 microns, 70 microns, 50 microns or 30 microns, depending on the medical indication. In some embodiments, the tubular body is configured to expand to the diameter of the blood vessel in the area where it is deployed. In some embodiments, exemplary deployment location can be at the level of the renal arteries. In some embodiments, at this level, the device covers also the ostium of the celiac trunk and the superior mesenteric artery. In some embodiments, at the proximal end, middle and / or distal end of the tubular body there is a capture device configured to trap debris. In some embodiments, in a rest position, the capture device is undeployed and allow free passage of blood flow and / or other medical devices. In some embodiments, in the actuated position, the capture is deployed by concentrically shrinking around any element that is in the blood vessel at that time (for example other medical devices), or shrinking completely, generating a filtering membrane barrier in the blood stream. In some embodiments, the filtering membrane can have a same or a different permeability from the tubular body. In some embodiments, the capturing element can be activated at the discretion of the operator once other tools already passed through the tubular body. For example, the capture element can be activated and released any number of times during the procedure. In some embodiments, as mentioned above, the capture element is configured for trapping particles and / or debris, keeping the particles within the capture element and allow extracting the particles with the device at the end of the procedure. In some embodiments, as mentioned above, the device optionally comprises a funnellike element that is operated from outside body and configured to (a) generating a funnel-like blood flow that temporarily reduces the blood volume that goes into the renal arteries, for example to be activated while using contrast media, in order to reduce the flow of the contrast material into the renal arteries; and / or to (b) generating a blood flow limiter to reduce the amount of blood flowing to the distal body, in order to temporarily assist the heart to stream more blood into the brain; and / or to (c) generating a temporary block of blood flow into the renal arteries by further extending the funnellike element to cover the ostium of the renal arteries, in order to further block and possibly temporarily completely block blood flow when contrast material is used. In some embodiments, the funnel-like element can be actuated to reach minimal to zero blood flow to distal parts of the body, generating a further effect of temporary heart assist. In some embodiments, the devices actuated from outside the body using, for example, a handle comprising levers, optionally, marked in letters and colors.

[0085] In some embodiments, the device comprises a cylindrical filtration element having a membrane from about 30 microns to about 120 microns, comprising an element that extends at all times outside the body of the patient. In some embodiments, the cylindrical filtration element comprises 3 to 6 parts or “leaves”, which overlap with each other. In some embodiments, the parts or leaves are interconnected to each other once deployed, to generate a full inner filtration coverage over the renal arteries, ostium, celiac and SMA. In some embodiments, each part is self-expanding filtration membrane. In some embodiments, the parts or leaves can be individually retracted from the body, without disturbing other devices located in the blood vessel.

[0086] 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 and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0087] Exemplary embolic protection devices

[0088] Referring now to Figures la-b showing schematic representations of an exemplary embolic protection device 100 (referred hereinafter just as “device”), according to some embodiments of the invention.

[0089] Referring to Figure la, in some embodiments, an exemplary embolic protection device 100 comprises an elongated body 102, comprising a proximal end 104 and a distal end 106. In some embodiments, the device 100 comprises an elongated element 108 connected to the elongated body 102, extending to the outside the body of the patient, and configured to hold the device 100 to allow manipulation of the entire device 100 and / or to actuate one or more elements (see below) in the device 100. In some embodiments, the device 100 comprises a handle 110 connected to the elongated element 108, from which the one or more elements are actuated.

[0090] In some embodiments, the elongated body 102 is or comprises a self-expandable mesh, having at least two states: an undeployed state having a first profile which fits in size and shape to an inner space of a delivery catheter; and a deployed state having a second profile, being bigger than the first profile, where the elongated body 102 expands to the size of the blood vessel where the device 100 is deployed. In some embodiments, the elongated body 102 comprises a frame and a mesh.

[0091] Referring to Figure lb, the device 100 is seen deployed from a catheter 114 within a blood vessel 112. In some embodiments, the device 100 comprises at least one optional ring 116 (referred hereinafter just as “ring”) configured to expand with a higher force than the elongated body 102 in order to provide anchoring to the device 100 after being deployed. In some embodiments, the ring 116 is controllable via the elongated element 108 to reduce its diameter and allow for movement of the device 100 along the blood vessel. In some embodiments, when non-actuated, the ring selfexpands back. In some embodiments, the ring 116 is at the distal end 106, or at the proximal end 104 or both. In some embodiments, the elongated element 108 is configured to actuate the elongated body 102 causing to reduce its diameter and, when non-actuated, the elongated body 102 self-expands back. In some embodiments, the elongated element 108 is configured to house one or more actuation mechanisms that cause an effect on the elongated body 102 and / or elements found therein (see below).

[0092] In some embodiments, additionally or alternatively, the elongated element 108 is configured to be attached to the elongated body 102 at all times to allow deployment and retrieval of the device.

[0093] In some embodiments, the mesh of the elongated body 102 comprises pores having a size from about 30 microns to about 200 microns, for example 30 microns, 50 microns, 70 microns, 100 microns, 120 microns, 200 microns. In some embodiments, the mesh comprises different areas comprising different sizes of pores, for example a first area having pores of sizes between about 30 microns and about 60 microns and a second area having pores of sizes between about 120 microns and about 200 microns.

[0094] Exemplary one or more elements of the device 100

[0095] In some embodiments, the device 100 comprises one or more elements:

[0096] 1. At least one capture element 202;

[0097] 2. At least one funnel-like element 302;

[0098] 3. At least one narrowing element 402;

[0099] 4. At least one balloon element 502;

[0100] 5. At least one blocking element 602.

[0101] In some embodiments, a single device 100 can comprise any combination of the elements.

[0102] Exemplary capture element

[0103] Referring now to Figures 2a-h showing schematic representations of a capture element, according to some embodiments of the invention. Reference is now made to Figures 2a-b, showing a device 100 with a capture element 202, comprising a plurality of leaves 204 or debris traps 204, or debris catching pockets 204. Figures 2a-b do not show a mesh which covers the leaves 204. Figure 2b shows an optional gradually-narrowing end 206 of the device 100. In some embodiments, the gradually-narrowing end 206 potentially enables pulling the device 100 into a catheter for extraction from a patient’s body. In some embodiments, the gradually-narrowing end 206 potentially pulls the device 100 into the catheter and assists in compressing the device as it enters. In some embodiments, the debris traps 204 are closed upon whatever debris the debris traps 204 trapped, when the device 100 is pulled into the catheter and extracted, together with the trapped debris, from the body.

[0104] Figure 2b shows a mesh which covers the leaves 204.

[0105] Reference is now made to Figures 2d-f, which schematic representations of an exemplary debris capture element, according to an example embodiment. Figures 2d-f show the debris capture element being gradually activated / actuated. Figures 2d-f show the elongated body 102, tips 204 of debris traps or tips 204 of debris trapping leaves, a control wire guide 208, and a control wire 210 which is threaded through loops at the tips 204. Figure 2d shows the tips 204 of the leaves laying against the elongated body 102. Figure 2e shows the wire 210 pulling the tips 204 of the leaves closer to each other. Figure 2f shows the wire 610 pulling the tips 204 of the leaves to completely close a cross section of a lumen defined by the elongated body 102. In some embodiments, the control wire guide 208 is optionally a lumen or pipe. In some embodiments, the control wire guide 208 is optionally constructed of nitinol or polymer. In some embodiments, there are one or more control wire guides 208. The example embodiment shown in Figures 2d-f shows two control wire guide 208. In some embodiments, the number of control wire guide 208 is optionally an even number, for example 2, 4, 6, 8 and so on. In some embodiments, the number of control wire guide 208 is not necessarily even. When the cross section of the lumen defined by the elongated body 102 is completely closed, all fluid flowing through the lumen needs to pass through the leaves. In an embodiment where the leaves are covered by a mesh, all fluid flowing through the lumen needs to pass through the mesh. It is noted that a medical tool can pass through the lumen of the device. It is clear that when the leaves lie against the elongated body 102, or the cross section is only partially closed, the medical tool can pass through the lumen of the device. It is pointed out that the wire 210 can be slightly released at any time, to allow the medical tool through, and the write can be slightly tightened to close upon the medical tool.

[0106] In some embodiments, an exemplary debris capture element can be positioned at the proximal end and / or at the distal end and / or at any position in between of the elongated body.

[0107] Figures 2g-h show images of prototypes of exemplary capture element 202, in an open configuration (Figure 2g) and in a close configuration (Figure 2h). It can be seen that the capture element in the open configuration comprises a first diameter, which allows the insertion and / or passage of medical instruments 902, while in the close configuration, the diameter decreases until “hugging” the medical instruments 902, thereby generating the “capture” area around the medical instruments 902.

[0108] In some embodiments, the capture elements 202 are configured to be used to reduce the blood flow in order to potentially assist during shock and / or heart failure.

[0109] Exemplary funnel-like element

[0110] Referring now to Figures 3a-c showing schematic representations of a funnel-like element, according to some embodiments of the invention. In some embodiments, the device 100 comprises a funnel-like element 302 configured to direct the flow, as shown for example in Figures 3a-b. In some embodiments, the funnel-like element 302 configured to direct and restrict the flow, as shown for example in Figure 3c. In some embodiments, the funnel-like element 302 comprises a mesh body or impermeable body. In some embodiments, the device 100 comprises an actuator (not shown) configured to actuate the funnel-like element 302 from a undeployed configuration where the walls of the funnel-like element 302 are attached to the walls of the elongated body 102 - to a deployed configuration as shown in Figures 3a-c. In some embodiments, the funnel-like element 302 is positioned at one or more of a proximal end, a distal end (as shown for example in Figure 3a) and anywhere along the wall of the elongated body (as shown for example in Figure 3b). elements

[0111] Referring now to Figures 4a-b showing schematic representations of an exemplary narrowing element, according to some embodiments of the invention. In some embodiments, the elongated body 102 comprises an area 402 that (reversibly) narrows in relation to the rest of the body. In some embodiments, narrowing the elongated body causes a reduction in the size of the pores, which then causes the redirection of the flow towards the center of the aorta to reduce the flow into the side branches. In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. Figure 4a shows an un-actuated narrowing portion and Figure 4b shows an actuated narrowing portion 402. balloons elements

[0112] Referring now to Figures 5a-b showing schematic representations of exemplary balloon elements, according to some embodiments of the invention. Figure 5a shows an elongated balloon 502 anchored art the center of the elongated body 102. In some embodiments, the balloon element 502 is inflated from outside the body when flow is needed to be either obstructed or reduced. Figure 5b shows a balloon element 504 positioned at the proximal end and configured to actuate as a capture balloon element.

[0113] In some embodiments, the balloon element comprises an inflated configuration and a deflated configuration. In some embodiments, a passage between the inflated configuration, the deflated configuration and vice versa is performed by delivering inflation means, like a liquid and / or a gas, through at least one mechanism, for example through the elongated element 108.

[0114] In some embodiments, the balloon element 504 can act as one or more of a capture element, a funnel-like element, a narrowing element and a blocking element.

[0115] Exemplary blocking elements 602

[0116] Referring now to Figures 6a-d showing schematic representations of exemplary blocking elements 602, according to some embodiments of the invention. In some embodiments, the device 100 comprise one or more blocking elements 602 configured to block the blood flow, either partially or completely (referred hereinafter just as “block” - but it is understood that it refers to either partial block or completely block). In some embodiments, the blocking element 602 is configured to be actively actuated to selectively block the blood flow.

[0117] Figures 6a-b show a first embodiment of a device 100 comprising an expandable elongated body 102 having a mesh 604 comprising pores having a size from about 30 microns to about 120 microns, for example 30 microns, 50 microns, 70 microns, 100 microns, 120 microns. In some embodiments, in the device 100, the elongated body 102 and the mesh 604 are irreversibly connected - in Figures 6a-b are shown slightly separated just for the sake of the explanations to better visualize the parts. In some embodiments, the device 100 comprises a blocking element 602 connected to the proximal end of the mesh 604 at side 606. In some embodiments, the distal end 608 of the blocking element 602 is configured to be actuated to reduce the diameter of the distal end 608 thereby deflecting the flow (see below). In some embodiments, as shown in Figure 6a, when the distal end 608 is not actuated, the blocking element 602 is pushed against the mesh 604 and the blood flow (wavy arrow 610) passes from distal to proximal along the device 100, while blood flow is blocked (marked by the “X”) towards the side branches by the blocking element 602. In some embodiments, as shown in Figure 6b, when the distal end 608 is actuated, the distal end 608 is reduced in diameter. This allows the blood flow be divided so as to pass: (1) Through the reduced opening of the distal end 608 (wavy arrow 610); and (2) between the mesh 604 and the blocking element 602 towards the side branches (wavy arrows 612-614).

[0118] Figures 6c-d show a second embodiment of a device 100 comprising an expandable elongated body 102 having a mesh 604 comprising pores having a size from about 30 microns to about 120 microns, for example 30 microns, 50 microns, 70 microns, 100 microns, 120 microns. In some embodiments, in the device 100, the elongated body 102 and the mesh 604 are irreversibly connected - in Figures 6c-d are shown slightly separated just for the sake of the explanations to better visualize the parts. In some embodiments, the device 100 comprises a blocking element 602 connected to the distal end of the mesh 604. In some embodiments, the proximal end 616 of the blocking element 602 is configured to be actuated to move distally beyond the device 100, thereby allowing multiple directions of flow (see below). In some embodiments, as shown in Figure 6c, when the proximal end 616 is not actuated, the blocking element 602 is pushed against the mesh 604 and the blood flow (wavy arrow 610) passes from distal to proximal along the device 100, while blood flow is blocked (marked by the “X”) towards the side branches by the blocking element 602. In some embodiments, as shown in Figure 6d, when the proximal end 616 is actuated, the proximal end 616 is moved beyond the distal end of the device 100. This allows the blood flow be pass: (1) Through the opening of the proximal end 616 (wavy arrow 610) and through the device 100; and (2) between the mesh 604 and the blocking element 602 towards the side branches (wavy arrows 612-614). multi-element devices

[0119] In some embodiments, as stated above, a device 100 can comprise a plurality of elements, for example, as shown in Figures 7a-b, showing an exemplary device 100 comprising a capture element 202, a narrowing element 402 and a balloon element 502; or for example as shown in Figures 7c-d, showing an exemplary device 100 comprising a capture element 202, a narrowing element 402 and a funnel-like element 302. The examples provided herein are provided just as examples and are not meant to be limiting in any way. A device 100 may comprise one element, two elements, all elements or no elements at all.

[0120] Exemplary elongated body 102

[0121] In some embodiments, as mentioned above, the elongated body is a self-expandable mesh having pores from about 30 microns to about 120 microns. In some embodiments, the body is a single unified body, as shown for example in Figure 8a. In some embodiments, the self-expandable mesh is a double mesh, as shown for example in Figure 8b. In some embodiments, the self-expandable mesh is a double ring comprising a spring-like body extending between the two rings, as shown for example in Figure 8c. In some embodiments, the self-expandable mesh is a multi-layer mesh having overlapped parts or “leaves”, as shown for example in Figure 8d. In some embodiments, the device comprises between 2 to 8 leaves with a small overlap between them. In some embodiments, the leaves are interconnected once deployed in order to generate a full inner coverage of filtration. In some embodiments, each leaf is a self-expanding unit. In some embodiments, the multi-layer mesh having overlapped leaves comprises a mechanism (not shown) that allows for the removal of each leaf individually, as will be further explained below, until the complete removal of the device.

[0122] Introduction to micro and macro embolic injuries

[0123] The inventors have found that during medical procedures that come to fix problems in the vascular system and / or in the heart, for example, aneurisms, aortic aneurisms, heart valve replacements, trauma, the mere insertion of medical devices into the vascular system may cause the release of embolic particles (both macro-embolic and micro-embolic) - for example calcifications, plaque, blood clots, tissue particles, polymer particles - into the blood stream, which then might arrive into the organs (kidneys, gastro-intestinal (GI) organs and abdomen\pelvic organs) and generate an ischemic injury, fibrosis, necrosis, interstitial disease, organ failure and mortality.

[0124] Figures 9a-b shows schematic representations of the aorta branches to help understand how the flow of blood coming from the heart reaches all the abovementioned organs and how it is plausible that macro-embolic and / or micro-embolic particles may reach one or more of the kidneys, the gastrointestinal (GI) organs and the abdomen\pelvic organs. The devices / system disclosed herein provide a suitable solution for embolic protection to the celiac trunk and / or renal arteries and / or SMA during and / or after medical procedures, the area as shown for example in Figure 9b.

[0125] In some embodiments, the devices disclosed herein provide embolic protection by blocking the passage of the macro-embolic and / or micro-embolic particles into the blood vessels departing from the aorta. In some embodiments, the devices disclose herein are positioned in the aorta before the medical procedures in a way that the devices block the passage of the macro-embolic and / or micro-embolic particles floating in the blood stream into the branches, while trapping the particles, so the particles can be extracted from the body, thereby potentially eliminating the risks of embolic damage. of devices into the aorta

[0126] Referring now to Figures 10a- w showing schematic representations of exemplary devices deployed in the aorta, according to some embodiments of the invention.

[0127] Figure 10a schematically show a self-expanding device 100, without elements and a ring 116, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns). The device is delivered and controlled for reposition (if needed) by actuating the ring 116 from outside the body.

[0128] Figure 10b schematically show a self-expanding device 100, with a capture element 202 and a ring 116, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the capture element 202 is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the capture element from outside the body.

[0129] Figure 10c schematically show a self-expanding device 100, with a capture element 202 and a ring 116, placed in the aorta similarly to what is shown in Figure 10b, and an exemplary surgical tool 1002 passing through the device 100 (see also Figures 2g-h), according to some embodiments of the invention.

[0130] Figure lOd schematically show a self-expanding device 100, with two capture elements 202, one at the proximal end and one at the distal end of the device 100, the device 100 placed in the aorta, according to some embodiments of the invention.

[0131] Figure lOe schematically show a self-expanding device 100, with a narrowing element 402 and a ring 116, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the narrowing element 402 is actively actuated to reduce the pores sizes and therefore directs the blood flow to the center of the aorta to reduce the flow into the side branches. In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the narrowing element from outside the body.

[0132] Figure lOf schematically show a self-expanding device 100, with a narrowing element 402 and a ring 116, placed in the aorta, and an exemplary surgical tool 1002 passing through the device 100, according to some embodiments of the invention. In some embodiments, the device 100 is inserted though one leg while the surgical tool is inserted through the other leg, as shown for example in Figure lOf. Figure 10g schematically show a self-expanding device 100, with an embodiment of a funnellike element 302 and a ring 116, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the funnel-like element 302 is actively actuated to direct the blood flow to the center of the aorta to reduce the flow into the side branches. In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. In some embodiments, the device can comprise both a funnel-like element 302 and a narrowing element 402, as shown for example in Figure 10g. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the narrowing element from outside the body.

[0133] Figure lOh schematically show a self-expanding device 100, with another embodiment of a funnel-like element 302 and a ring 116, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the funnel-like element 302 is actively actuated to direct the blood flow to the center of the aorta to reduce the flow into the side branches. In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the funnel-like element 302 from outside the body.

[0134] Figure lOi schematically show a self-expanding device 100, with a capture element 202 and a funnel-like element 302, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the capture element 202 is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. Additionally, the funnel-like element 302 is actively actuated to direct the blood flow to the center of the aorta to reduce the flow into the side branches. In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. The device is delivered and controlled for reposition (if needed) and actuation of the capture element 202 and the funnel-like element 302, optionally separately, from outside the body.

[0135] Figure lOj schematically show a self-expanding device 100, with a capture element 202, a ring 116 and a longer funnel-like element 302, placed in the aorta, according to some embodiments of the invention. The device is similar to that explained in Figure lOi, with the difference that the funnel-like element 302 is longer in length which allows to further direct the flow towards the center of the aorta and directly into the capture element 202. In some embodiments, additionally or alternatively, the longer funnel-like element 302 limits the blood flow to potentially assist during shock and / or heart failure. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the capture element 202 and the funnel-like element 302, optionally separately, from outside the body.

[0136] Figure 10k schematically show a self-expanding device 100, with a ring 116, a capture element 202 and a blocking element 602, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the capture element 202 is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. Additionally, the blocking element 602 is actuated to limit the blood flow to potentially assist during shock and / or heart failure. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the capture element 202 and the blocking element 602, optionally separately (two elongated elements 108 for controlling elements are shown in Figure 10k), from outside the body.

[0137] Figure 101 schematically show a self-expanding device 100, with a capture element 202 and a narrowing element 402, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the capture element 202 is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. Additionally, the narrowing element 402 is actively actuated to reduce the pores sizes and therefore directs the blood flow to the center of the aorta to reduce the flow into the side branches. In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. The device is delivered and controlled for reposition (if needed) and actuation of the capture element 202 and the narrowing element 402, optionally separately, from outside the body.

[0138] Figure 10m schematically show a self-expanding device 100 placed in the aorta, according to a location chosen by the user / physician, the device 100 having a capture element 202 and a ring 116, and a longer elongated body 102 configured to protect most, if not all, the blood vessels branching out from the aorta, including the lumbar arteries 1006, according to some embodiments of the invention. The capture element 202 is and is controlled as previously disclosed.

[0139] Figure lOn schematically show a self-expanding device 100, with a capture element 202 and a balloon element 502, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the capture element 202 is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. Additionally, the balloon element 502 is actuated to limit the blood flow to potentially assist during shock and / or heart failure. The device is delivered and controlled for reposition (if needed) and actuation of the capture element 202 and the balloon element 502, optionally separately (two elongated elements 108 for controlling elements are shown in Figure lOn), from outside the body.

[0140] Figure lOo schematically show a self-expanding device 100, with a balloon element 502 and a capture element 202 positioned at the distal end of the device 100, placed in the aorta, according to a location chosen by the user / physician, according to some embodiments of the invention. The device is similar to that explained in Figure 9n, with the difference of the position of the capture element 202.

[0141] Figure lOp schematically show a self-expanding device 100, with a ring 116, an elongated capture element 202, and an exemplary surgical tool 1002 passing through the device 100, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the capture element 202 is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. Additionally, the elongated capture element 202 is actuated to temporarily block the blood flow into the side branches (kidneys). In some embodiments, as mentioned above, this mechanism can be used when utilizing contrast material to reduce the passage of the contrasty material into the kidney to potentially reduce the damage to the kidneys. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the elongated capture element 202 from outside the body.

[0142] Figure lOq schematically show a self-expanding device 100, with a ring 116, a balloon element 502 functioning as a capture element, according to a location chosen by the user / physician, according to some embodiments of the invention. In some embodiments, the elongated body 102 works passively as a filter blocking the passage of micro and / or macro emboli into the side branches (due to the mesh having pores between 30 microns to about 120 microns), while the ballon element 502 acting as a capture element is actively actuated to catch micro and / or macro emboli, which will be taken out the body of the patient together with the device 100. The device is delivered and controlled for reposition (if needed by actuating the ring 116) and actuation of the ballon element 502 from outside the body.

[0143] Figure lOr schematically show a self-expanding device 100, with a ring 116 and a capture element 202, placed in the aorta and before being moved (repositioned) distally during the procedure, according to some embodiments of the invention.

[0144] Figure 10s schematically show a self-expanding device 100, with a capture element 202, placed in the aorta after being moved (repositioned) distally during the procedure, according to some embodiments of the invention.

[0145] Figures lOt-u schematically show a self-expanding device 100 as shown for example in Figures 6a-b, in an open configuration (Figure lOt) and in a close configuration (Figure lOt). In some embodiments, in the open configuration, flow is blocked completely or partially towards the side branches, while in the close configuration flow passes through the device and towards the side branches.

[0146] Figures lOv-w schematically show a self-expanding device 100 as shown for example in Figures 6c-d, in a close configuration (Figure lOv) and in a deployed configuration (Figure lOw). In some embodiments, in the close configuration, flow is blocked completely or partially towards the side branches, while in the deployed configuration flow passes through the device and towards the side branches.

[0147] Introduction to EV AR and TEVAR procedures

[0148] Endovascular aneurysm repair (EVAR) is a minimally invasive procedure used to manage abdominal aortic aneurysms while Thoracic endovascular aneurysm repair (TEVAR) treats aneurysms in the thorax (chest), for example in the descending aorta.

[0149] Regarding EVAR procedures, as shown for example in Figures l la-b, a stent graft 1102 is positioned in the aorta at the location of the aneurysm 1104. Usually, the stent graft 1102 comprises a central part and two “legs” extending towards the arteries - see Figure 1 lb, in order to allow for a better anchoring of the stent graft 1102 and potentially guarantee proper flow of blood.

[0150] It is known that the procedure of placing the stent graft 1102 is complicated and time consuming. In some embodiments, it is part of the scope of the invention to provide embolic protection during EVAR or TEVAR procedures, without disturbing the deployment of the stent graft 1102 and without affecting the implanted stent graft 1102 after implantation.

[0151] In the following paragraphs, examples of devices and / or methods will be explained in relation to EVAR procedures. It should be understood that the same can eb used also for TEVAR procedures. Exemplary devices used for EVAR

[0152] Referring now to Figure 12a, showing a schematic representation of an exemplary device deployed in the aorta, and configured to be used in EVAR procedures, according to some embodiments of the invention. In some embodiments, the device 100 is as disclosed before, for example, comprising a self-expanding elongated body 102 and a capture element 202. In some embodiments, the area marked as 1202 can be collapsed (schematically shown by the arrows and the band in the middle) and moved to allow the deployment of the stent graft 1102 (not shown). In some embodiments, the retraction comprises leaving the capture element 202 deployed, which can be moved either proximally or distally to provide protection against micro / macro emboli while the stent graft 1102 is being deployed.

[0153] Referring now to Figure 12b, showing a schematic representation of another exemplary device deployed in the aorta, and configured to be used in EVAR procedures, according to some embodiments of the invention. In some embodiments, the device 100 is as disclosed before, for example, comprising a self-expanding elongated body 102, a ring 116 and a capture element 202. In some embodiments, the elongated body 102 is as disclosed in relation to Figure 8d, where the elongated body is a multi-layer mesh having overlapped leaves (referred hereinafter as overlappedleaves device) configured, when needed, to be extracted one after the other. The elongated body 102 shown in Figure 12b comprise leaves that are positioned with different orientations (for example: crisscross pattern). In some embodiments, each leaf comprises a dedicated extraction wire that runs along the elongated body 108 outside the body, where the user can pull and extract each leaf individually.

[0154] In some embodiments, the overlapped-leaves device is deployed at the beginning of the procedure, thereby ensuring embolic protection. Then the user can deploy the stent graft 1102 on top of the overlapped-leaves device. Once the stent graft 1102 has been correctly positioned, the user can extract the overlapped-leaves device by extracting one leaf at a time, thereby not affecting the already deployed stent graft 1102. Figure 12c shows a similar overlapped-leaves device as shown in Figure 12b, but instead of having a crisscross pattern, the device comprises a diagonal- unidirectional pattern.

[0155] Referring now to Figure 12d, showing a schematic representation of yet another exemplary device deployed in the aorta, and configured to be used in EVAR procedures, according to some embodiments of the invention. In some embodiments, the device 100 is as disclosed before, for example, comprising a self-expanding elongated body 102, a ring 116 and a capture element 202. In some embodiments, the elongated body 102 is as disclosed in relation to Figure 8c, where the elongated body is winded wire (spring-like) (referred hereinafter as spring device) configured, when needed, to be extracted by pulling one side (for example the proximal) and extracting the device as a single wire. In some embodiments, the spring device can be deployed from distal to proximal or from proximal to distal. In some embodiments, the spiral part can be shortened or elongated as needed. In some embodiments, during the EVAR procedure, the spiral is retracted or pulled or pushed to leave the necessary space for the positioning of the stent graft 1102. In some embodiments, retraction / repo sition of the spiral is performed while leaving the capture element 202 in place - as shown for example in Figure 12e. In Figure 12e, part of the stent graft 1102 is positioned while the spiral is being retracted by rotating the spiral on its longitudinal axis to reduce the diameter of the spiral and provide the necessary space for the deployment of the stent graft 1102, all this while the capture element 202 stays deployed providing embolic protection to the lower extremities. In some embodiments, not shown in Figure 12e, the capture element 202 is positioned at the distal end, which means that during the deployment of the stent graft 1102, the side branches are also being protected from emboli.

[0156] Figure 12f, shows a device, similar to those shown in relation to Figures 12d-e that is being retracted distally.

[0157] In some embodiments, any of the devices disclosed herein are configured to be deployed within the stent graft 1102 after the deployment of the stent graft 1102.

[0158] Exemplary general principles of the devices and methods thereof

[0159] In some embodiments, as mentioned above, the devices described herein are configured to provide embolic protection against micro and / or macro emboli. In some embodiments, the devices are delivered into the body percutaneously from either the femoral access or the contra lateral femoral access. In some embodiments, the devices are operated from outside the body to adjust positioning and / or actuate elements in the device. In some embodiments, the devices are configured to potentially provide (optionally) constant and (potentially) complete embolic protection to the renal arteries, Celiac trunk and SMA, in a passive manner by positioning the device along the aorta covering the side branches. In some embodiments, the devices are configured to actively trap emboli using for example capture elements as disclosed herein. In some embodiments, the devices are configured to be used to cause redirection of flow (using funnel-like elements), to cause block of flow (using blocking elements) in order to protect organs from contrast materials, to limit flow to assist during stroke and / or heart failure.

[0160] In some embodiments, the device(s) is inserted before the medical procedure in order to guarantee that emboli caused because and during the medical procedure do not reach organs and are optionally trapped and extracted from the body of the patient. In some embodiments, optionally, the devices are configured to stay in the body of the patient hours / days after the procedure to provide continued protection. In some embodiments, the devices are configured to allow easy reposition before and during the procedure, by actuating one or more elements from outside the body, and moving the device distally / proximally as needed.

[0161] In some embodiments, exemplary methods of comprise protecting one or more of renal arteries, celiac trunk and SMA from macro and / or micro emboli by deploying a device (as disclosed herein) before the beginning of a medical procedure, leaving the device during the whole time of the procedure, optionally leaving the device in place hours / days after the end of the procedure, and taking out the devices from the patient. In some embodiments, during the medical procedure, the devices are actively actuated to enhance the embolic protection. In some embodiments, the actuation comprises actuating one or more elements in the devices (see above). For example, capture elements are actuated to capture emboli. For example, blocking elements are actuated to protect the kidneys from contrast materials. For example, actuating the device to restrict it size to allow deployment of other medical devices (like stents). In some embodiments, the actuation is performed from outside the body. A potential advantage of allowing actuation from outside the body is that it potentially allows the user / physician to react to various \ unexpected procedure occurrences \ unexpected complications. In some embodiments, the device comprise a relaxed state, where the device is not actuated and other medical devices can be used without interference. For example, delivery catheters can be deployed into the heart from the femoral entry without being interfered by the protection embolic device. In some embodiments, the devices are configured to allow the passage of other medical devices, configured to allow easy repositioning and easy retrieval. In some embodiments, the device can be used also in open surgeries. In some embodiments, the devices can be delivered via one or more of: Contralateral Femoral artery, Trans Arterial access and Trans Apical access. In some embodiments, other retrograde arterial access can be chosen by the physician, for example, in case of open surgery. In some embodiments, as mentioned above, the exemplary devices (with or without one or more elements), which comprise an elongated self-expanding body, are deployed from a catheter, and allowed to self-expand. The ring 116 of the device has a higher radial force fixation are, which helps anchoring the device in place. In some embodiments, method of treatment and / or embolic prevention comprises positioning the device at one of the following locations: at the level of the renal arteries, covering the ostium of the Celiac trunk and the Superior mesenteric artery, where the device comprises at the proximal, middle and / or distal end a capture device.

[0162] In some embodiments, the capture device is normally open, allowing passage of medical tools\catheters through. In some embodiments, once activated from outside the body, the capture element concentrically shrinks around any element that is in the blood vessel at that time, or, in the absence of tools, shrinks completely, generating a filtrating membrane barrier in the blood stream. In some embodiments, the filtrating membrane comprises a same permeability along the whole membrane or may comprise different levels if permeability at different location in the membrane. For example, the membrane comprises pores having a size from about 30 microns to about 120 microns. In some embodiments, the capture element is activated at the discretion of the operator once other tools already passed through the device. In some embodiments, the capture element can be activated and released couple of times during the procedure. In some embodiments, the capture element is configured to trap particles. In some embodiments, these trapped particles are kept within the capture element and are evacuated out of the body at the end of the procedure.

[0163] In some embodiments, the funnel-type element, which can also be operated from outside body, can be activated, for example, for two operations:

[0164] (a) Generating a funnel type blood flow, that temporarily reduces the blood volume that goes into the renal arteries. In some embodiments, this can be activated while using contrast media to reduce the flow of contrast into the renal arteries.

[0165] (b) Generating blood flow limiter to reduce the amount of blood flowing to the distal proximities in the body of the patient. In some embodiments, this is used temporarily to assist the heart in streaming more blood to the brain.

[0166] (c) The funnel-like element can be further extended to cover the ostium of the renal arteries, creating temporary block of blood streaming into the renal arteries . this is a further conclusive block when contrast material is used. In some embodiments, the funnel-like can be further opened to reach minimal to zero distal blood flow, generating a further effect of temporary heart assist.

[0167] In some embodiments, any of the method disclosed herein comprises actuating the devices herein from outside the body. In some embodiments, the devices are actuated using a handle with operating levers, optionally marked in letters and different colors. In some embodiments, the handle is connected to the device - the elongated body 102 during all time, from delivery - deployment to retraction out of the body.

[0168] In some embodiments, as mentioned herein, the device is deployed before the medical procedure. In some embodiments, the device can be deployed before any type of surgery, including laparoscopic procedures, BAILOUT situations and trauma cases. In some embodiments, the device is connected to a delivery system during the duration of the whole procedure. In some embodiments, once deployed, the device protects the renal arteries and kidneys from Embolic debris and micro embolic particles. In some embodiments, the device comprises a membrane having pores of 30-120 microns made from PET or other polymer, and is placed between or side by side with NITINOL or other medical metal or polymer scaffold. In some embodiments, the device is self-expandable, and once positioned is also forced to aortic walls due to blood pressure.

[0169] In some embodiments, during EVARVTEVAR stent graft delivery, it is optionally required to move and / or retract the device to give space to the physician to deploy the stent. In some embodiments, the device is configured to be actuated from outside the body, by actuating a handle, to concentrically reduce its size and allow movement of the device so it can be moved / retracted. In some embodiments, the device filtration part is moved in the collapsed position direction distal body, and then, it can be repositioned, while the capture element is kept activated. In certain medical cases where the EVAR / TEVAR is too distal, the device will be collapsed, but the capture element in its new deployment position is activated to protect distal parts of the body of the patient from embolic debris. In some embodiments, the device can be collapsed and retrieved from the body in any point of time during the medical procedure. In some embodiments, the device is inserted into the body via contra lateral femoral access, or any other access that physician finds suitable. In some embodiments, as mentioned before, the body of the retractable embolic protection device has leaves made from polymer overlapping with each other. In some embodiments, the leaves can be concentrically collapsed and retracted to move the device to any direction. In some embodiments, the capture element is configured to stay in same place or retracted distally, while the leaves are moved. In some embodiments, optionally, if needed, the device can be re inserted and deployed inside the stent graft.

[0170] In some embodiments, the devices described herein are configured to be used in concomitance with other medical devices, like catheters, by mounting the embolic protection devices on the catheter and sliding them along the catheter until reaching the desired location.

[0171] In some embodiments, an aortic embolic protection device comprises: a. an elongated selfexpandable body, comprising a proximal end and a distal end; said elongated self-expandable body sized and shaped to extend along an aorta; b. at least one element; c. at least one mechanism for controlling said at least one element. In some embodiments, the elongated self-expandable body comprises a frame and a mesh covering the frame. In some embodiments, the mesh comprises pores having a size of from about 30 microns to 120 microns. In some embodiments, the mesh comprises different areas comprising pores of different sizes. In some embodiments, the mechanism extends from the aortic embolic protection device to an outside of a patient. In some embodiments, the at least one element is controlled from outside the patient. In some embodiments, the elongated selfexpandable body comprises at least two configurations: a first undeployed configuration in which the elongated self-expandable body is sized and shaped to fit within a delivery catheter, and a second deployed configuration in which the elongated self-expandable body is allowed to self-expand into the space into which is being delivered. In some embodiments, the at least one element is at least one ring positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body; the at least one ring characterized by having a higher radial force than the selfexpandable mesh thereby configured to anchor the aortic embolic protection device in place. In some embodiments, the at least one element is at least one capture element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one capture element comprises an open configuration and a close configuration; wherein a movement between the open configuration, the close configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, the at least one element is at least one funnel-like element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one funnel-like element comprises a deployed configuration and an undeployed configuration; wherein a movement between the deployed configuration, the undeployed configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, the at least one element is at least one narrowing element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one narrowing element comprises an actuated configuration and an unactuated configuration; wherein a movement between the actuated configuration, the unactuated configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, actuation of the at least one narrowing element causes a change in a porosity of the elongated self-expandable body. In some embodiments, the at least one element is at least one balloon element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one balloon element comprises an inflated configuration and a deflated configuration; wherein a passage between the inflated configuration, the deflated configuration and vice versa is performed by delivering inflation means through the at least one mechanism. In some embodiments, the at least one balloon element is configured to act as one or more of a capture element, a funnel-like element, a narrowing element and a blocking element. In some embodiments, the at least one element is at least one blocking element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one blocking element comprises an actuated configuration and an unactuated configuration; wherein a movement between the actuated configuration, the unactuated configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, the elongated selfexpandable body is one or more of a single body, a double mesh body, multi-layer mesh body, a multi-layer mesh having overlapped parts. In some embodiments, the overlapped parts are configured to be extracted separately one from another. In some embodiments, the elongated self-expandable body extends from a heart-side of a celiac trunk to distal of a lowest lumbar artery. In some embodiments, the elongated self-expandable body is configured to cover one or more of the following side branches of the aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0172] In some embodiments, a method for providing aortic embolic protection to a patient during a medical procedure, comprises: a. positioning an aortic embolic protection device as described above; and b. actuating at least one element of the aortic embolic protection device during the medical procedure. In some embodiments, the method further comprises repositioning the aortic embolic protection device if needed. In some embodiments, the method further comprises leaving the aortic embolic protection device in the patient after the medical procedure. In some embodiments, the method further comprises removing the aortic embolic protection device from the patient after the medical procedure. In some embodiments, the positioning comprises positioning the elongated selfexpandable body to extend from a heart-side of a celiac trunk to distal of a lowest lumbar artery. In some embodiments, the positioning comprises positioning the elongated self-expandable body to cover one or more of the following side branches of the aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0173] In some embodiments, an aortic embolic protection device for use in EVAR / TEVAR procedures, comprises: a. an elongated self-expandable body, comprising a proximal end and a distal end; the elongated self-expandable body sized and shaped to extend along an aorta; b. at least one element; c. at least one mechanism for controlling the at least one element; wherein the elongated self-expandable body is a multi-layer mesh having overlapped parts. In some embodiments, each part of the multi-layer mesh comprises a frame and a mesh covering the frame. In some embodiments, the mesh comprises pores having a size of from about 30 microns to 120 microns. In some embodiments, the mesh comprises different areas comprising pores of different sizes. In some embodiments, the mechanism extends from the aortic embolic protection device to an outside of a patient. In some embodiments, the at least one element is controlled from outside the patient. In some embodiments, the elongated self-expandable body comprises at least two configurations: a first undeployed configuration in which the elongated self-expandable body is sized and shaped to fit within a delivery catheter, and a second deployed configuration in which the elongated self-expandable body is allowed to self-expand into the space into which is being delivered. In some embodiments, the at least one element is at least one ring positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body; the at least one ring characterized by having a higher radial force than the self-expandable mesh thereby configured to anchor the aortic embolic protection device in place. In some embodiments, the at least one element is at least one capture element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one capture element comprises an open configuration and a close configuration; wherein a movement between the open configuration, the close configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, the at least one element is at least one funnel-like element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one funnel-like element comprises a deployed configuration and an undeployed configuration; wherein a movement between the deployed configuration, the undeployed configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, the at least one element is at least one narrowing element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one narrowing element comprises an actuated configuration and an unactuated configuration; wherein a movement between the actuated configuration, the unactuated configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, actuation of the at least one narrowing element causes a change in a porosity of the elongated self-expandable body. In some embodiments, the at least one element is at least one balloon element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one balloon element comprises an inflated configuration and a deflated configuration; wherein a passage between the inflated configuration, the deflated configuration and vice versa is performed by delivering inflation means through the at least one mechanism. In some embodiments, the at least one balloon element is configured to act as one or more of a capture element, a funnel-like element, a narrowing element and a blocking element. In some embodiments, the at least one element is at least one blocking element positioned on one or more of the distal end, the proximal end and anywhere along the elongated self-expandable body. In some embodiments, the at least one blocking element comprises an actuated configuration and an unactuated configuration; wherein a movement between the actuated configuration, the unactuated configuration and vice versa is performed by actuating the at least one mechanism. In some embodiments, the elongated selfexpandable body is one or more of a single body, a double mesh body, multi-layer mesh body. In some embodiments, the overlapped parts are configured to be extracted separately one from another. In some embodiments, the elongated self-expandable body extends from a heart- side of a celiac trunk to distal of a lowest lumbar artery. In some embodiments, the elongated self-expandable body is configured to cover one or more of the following side branches of the aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0174] In some embodiments, a method for providing aortic embolic protection to a patient during a medical procedure, comprises: a. positioning an aortic embolic protection device as described above; and b. actuating at least one element of the aortic embolic protection device during the medical procedure. In some embodiments, the method further comprises repositioning the aortic embolic protection device if needed. In some embodiments, the method further comprises leaving the aortic embolic protection device in the patient after the medical procedure. In some embodiments, the method further comprises removing the aortic embolic protection device from the patient after the medical procedure. In some embodiments, the positioning comprises positioning the elongated selfexpandable body to extend from a heart-side of a celiac trunk to distal of a lowest lumbar artery. In some embodiments, the positioning comprises positioning the elongated self-expandable body to cover one or more of the following side branches of the aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

[0175] Referring to Figure 13 showing a flowchart of an exemplary method of use of embolic protection devices, according to some embodiments of the invention.

[0176] In some embodiments, an exemplary method of use of the devices disclosed herein comprises one or more of the following actions:

[0177] 1. Inserting the device into the body (1302).

[0178] 2. Positioning the device at the desired location (1304). In some embodiments, the location is in the aorta. In some embodiments, positioning comprises positioning so as to cover one or more of the renal arteries, Celiac trunk and SMA.

[0179] 3. Deploying the device to allow the device to self-expand (1306).

[0180] 4. Optionally, actuating one or more elements in the device during the medical procedure (1308).

[0181] 5. Optionally, re-positioning the device during the medical procedure, if needed (1310).

[0182] In some embodiments, the actuating is performed at the same time of the re -positioning. 6. Optionally, leaving the device in the patient after the medical procedure, to provide protection after the medical procedure (1312).

[0183] 7. Removing device from patient (1314).

[0184] Referring to Figure 14 showing a flowchart of an exemplary method of use of embolic protection devices in EVAR / TEVAR procedures, according to some embodiments of the invention.

[0185] In some embodiments, an exemplary method of use of the devices disclosed herein in EVAR / TEVAR procedures comprises one or more of the following actions:

[0186] 1. Inserting the device into the body (1402).

[0187] 2. Positioning the device at the desired location (1404). In some embodiments, the location is in the aorta. In some embodiments, positioning comprises positioning so as to cover one or more of the renal arteries, Celiac trunk and SMA.

[0188] 3. Deploying the device to allow the device to self-expand (1406).

[0189] 4. Optionally, actuating one or more elements in the device during the medical procedure (1408).

[0190] 5. Optionally, re-positioning the device during the medical procedure, if needed (1410).

[0191] In some embodiments, the actuating is performed at the same time of the re -positioning.

[0192] 6. Optionally, leaving the device in the patient after the medical procedure, to provide protection after the medical procedure (1412).

[0193] 7. Removing device from patient by extracting parts of the device one after the other (1414). In some embodiments, the extracting comprises extracting leaves of the elongated body one after the other in order to avoid disturbing the deployed stent graft.

[0194] In some embodiments, additional methods include, for example, methods of reducing blood flow, for example to avoid damaging the kidneys and / or to assist during stroke or heart issues, by actuating an element in the device (capture and / or funnel-like and / or balloon); methods for blocking blood flow, optionally temporarily, for example to avoid damaging the kidneys and / or to assist during stroke or heart issues, by actuating an element in the device (blocking element and / or balloon); methods for capturing embolic particles, by actuating an element in the device (capture and / or funnellike and / or balloon); methods for BAILOUT actions, by actuating an element (anyone) in the device, and other methods either explicitly or implicitly disclose herein.

[0195] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’. The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0196] The term “consisting of’ means “including and limited to”.

[0197] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0198] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0199] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0200] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0201] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art

[0202] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0203] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0204] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0205] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0206] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. An aortic embolic protection device for use in EVAR / TEVAR procedures, comprising: a. an elongated self-expandable body, comprising a proximal end and a distal end; said elongated self-expandable body sized and shaped to extend along an aorta; b. at least one element; c. at least one mechanism for controlling said at least one element; wherein said elongated self-expandable body is a multi-layer mesh having overlapped parts.

2. The aortic embolic protection device according to claim 1, wherein each part of said multilayer mesh comprises a frame and a mesh covering said frame.

3. The aortic embolic protection device according to claim 2, wherein said mesh comprises pores having a size of from about 30 microns to 120 microns.

4. The aortic embolic protection device according to claim 2, wherein said mesh comprises different areas comprising pores of different sizes.

5. The aortic embolic protection device according to claim 1, wherein said mechanism extends from said aortic embolic protection device to an outside of a patient.

6. The aortic embolic protection device according to claim 1, wherein said at least one element is controlled from outside said patient.

7. The aortic embolic protection device according to claim 1, wherein said elongated selfexpandable body comprises at least two configurations: a first undeployed configuration in which said elongated self-expandable body is sized and shaped to fit within a delivery catheter, and a second deployed configuration in which said elongated self-expandable body is allowed to self-expand into the space into which is being delivered.

8. The aortic embolic protection device according to claim 1, wherein said at least one element is at least one ring positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body; said at least one ring characterized by having a higher radial force than said self-expandable mesh thereby configured to anchor said aortic embolic protection device in place.

9. The aortic embolic protection device according to claim 1, wherein said at least one element is at least one capture element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

10. The aortic embolic protection device according to claim 9, wherein said at least one capture element comprises an open configuration and a close configuration; wherein a movement betweensaid open configuration, said close configuration and vice versa is performed by actuating said at least one mechanism.

11. The aortic embolic protection device according to claim 1, wherein said at least one element is at least one funnel-like element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

12. The aortic embolic protection device according to claim 11, wherein said at least one funnellike element comprises a deployed configuration and an undeployed configuration; wherein a movement between said deployed configuration, said undeployed configuration and vice versa is performed by actuating said at least one mechanism.

13. The aortic embolic protection device according to claim 1, wherein said at least one element is at least one narrowing element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

14. The aortic embolic protection device according to claim 13, wherein said at least one narrowing element comprises an actuated configuration and an unactuated configuration; wherein a movement between said actuated configuration, said unactuated configuration and vice versa is performed by actuating said at least one mechanism.

15. The aortic embolic protection device according to claim 13, wherein actuation of said at least one narrowing element causes a change in a porosity of said elongated self-expandable body.

16. The aortic embolic protection device according to claim 1, wherein said at least one element is at least one balloon element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

17. The aortic embolic protection device according to claim 16, wherein said at least one balloon element comprises an inflated configuration and a deflated configuration; wherein a passage between said inflated configuration, said deflated configuration and vice versa is performed by delivering inflation means through said at least one mechanism.

18. The aortic embolic protection device according to claim 16, wherein said at least one balloon element is configured to act as one or more of a capture element, a funnel-like element, a narrowing element and a blocking element.

19. The aortic embolic protection device according to claim 1, wherein said at least one element is at least one blocking element positioned on one or more of said distal end, said proximal end and anywhere along said elongated self-expandable body.

20. The aortic embolic protection device according to claim 19, wherein said at least one blocking element comprises an actuated configuration and an unactuated configuration; wherein a movementbetween said actuated configuration, said unactuated configuration and vice versa is performed by actuating said at least one mechanism.

21. The aortic embolic protection device according to claim 1, wherein said elongated selfexpandable body is one or more of a single body, a double mesh body, multi-layer mesh body.

22. The aortic embolic protection device according to claim 1, wherein said overlapped parts are configured to be extracted separately one from another.

23. The aortic embolic protection device according to claim 1, wherein said elongated selfexpandable body extends from a heart-side of a celiac trunk to distal of a lowest lumbar artery.

24. The aortic embolic protection device according to claim 1, wherein said elongated selfexpandable body is configured to cover one or more of the following side branches of said aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

25. A method for providing aortic embolic protection to a patient during a medical procedure, comprising: a. positioning an aortic embolic protection device according to claim 1; and b. actuating at least one element of said aortic embolic protection device during said medical procedure.

26. The method according to claim 25, further comprising repositioning said aortic embolic protection device if needed.

27. The method according to claim 25, further comprising leaving said aortic embolic protection device in said patient after said medical procedure.

28. The method according to claim 25, further comprising removing said aortic embolic protection device from said patient after said medical procedure.

29. The method according to claim 25, wherein said positioning comprises positioning said elongated self-expandable body to extend from a heart-side of a celiac trunk to distal of a lowest lumbar artery.

30. The method according to claim 25, wherein said positioning comprises positioning said elongated self-expandable body to cover one or more of the following side branches of said aorta: celiac trunk, superior mesenteric artery (SMA), renal arteries, lumbar arteries, inferior mesenteric artery (IMA).

Images