Supplying blood during debris protection mode

Abstract

A device for controlling flow of blood to arteries branching from an aorta, the device including a mesh for blocking debris from entering arteries branching from the aorta, and a controllable obstacle shaped and sized to deploy across the aorta under external control and impede blood flow downstream along the aorta. A method for controlling flow of blood to arteries branching from an aorta, the method including inserting a controllable obstacle into an aorta, and controlling the controllable obstacle to deploy, blocking a portion of a cross section of the aorta, thereby decreasing blood flow downstream of the deployed controllable obstacle, increasing blood pressure upstream of the deployed controllable obstacle, and increasing blood flow to arteries branching from the aorta. Related apparatus and methods are also described.

Description

[0001] SUPPLYING BLOOD DURING DEBRIS PROTECTION MODE

[0002] RELATED APPLICATIONS

[0003] This application claims the benefit of priority of U.S. Provisional Patent No. 63 / 535,603, filed on August 31, 2023.

[0004] This application is also related to PCT Patent Application No. PCT / IL2023 / 050901 filed on August 24, 2023, titled “PROTECTING CORONARY ARTERIES AND MYOCARDIUM BLOOD VESSELS DURING MEDICAL PROCEDURES”.

[0005] The contents of the above application are all incorporated by reference as if fully set forth herein in their entirety.

[0006] FIELD AND BACKGROUND

[0007] The present disclosure, in some embodiments thereof, relates to devices and methods to protect brain and / or coronary arteries from entry of debris while also maintaining supply of blood to the brain and / or coronary arteries and, more particularly, but not exclusively, during medical procedures.

[0008] Blood borne debris such as emboli, calcification particles, plaque and detached plaque particles, tissue particles like myocardial tissue endothelial tissue and others, particles from foreign sources - metals, polymers and others can be dangerous, the debris may cause a pathological event, for example accompanying illness or injury or even medical procedures.

[0009] For example, in trans-catheter aortic valve implantation (TAVI), particles were found in the brain in 90% of patients by diffusion-weighted magnetic resonance imaging (DWI or DW-MRI). There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification), and additional particles: atherosclerotic plaque, myocardial tissue, endothelium tissue, and foreign particles of unknown source - such as polymers and gas and / or air bubbles. A source of these particles source is probably the left ventricle and the area where TAVI was performed. Special attention is given to micro-emboli, namely small particles in a size range of 150 micron to 120 micron down to a range of 50 micron to 30 micron. The micro-emboli particles are scientifically known to migrate to the arterioles, causing a cascade or chain of micro biological events such as-vasoconstriction of the arterioles, blockage of flow of red blood cells, edema, necrosis and / or fibrosis in neighboring tissues, evoking secretion and diffusion of bio-materials that damage nearby tissues and evoke apoptosis.

[0010] Additional background art includes: International Patent Application Publication No. WO 2019 / 064223 by Zeev Brandeis, titled: “Aortic Protection”.

[0011] The disclosures of all references mentioned above and throughout the present specification, as well as the disclosures of all references mentioned in those references, are hereby incorporated herein by reference.

[0012] SUMMARY

[0013] The present disclosure, in some embodiments thereof, relates to devices and methods to protect brain and / or coronary arteries from entry of debris while also maintaining supply of blood to the brain and / or coronary arteries and, more particularly, but not exclusively, during medical procedures.

[0014] According to an aspect of some embodiments of the present disclosure there is provided a device for controlling flow of blood to arteries branching from an aorta, the device including a mesh for blocking debris from entering arteries branching from the aorta, and a controllable obstacle shaped and sized to deploy across the aorta under external control and impede blood flow downstream along the aorta.

[0015] According to some embodiments of the disclosure, the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 50 percent of a cross section of the aorta.

[0016] According to some embodiments of the disclosure, the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 100 percent of a cross section of the aorta.

[0017] According to some embodiments of the disclosure, the controllable obstacle includes an inflatable balloon.

[0018] According to some embodiments of the disclosure, the device includes a tube to control inflation and deflation of the inflatable balloon.

[0019] According to some embodiments of the disclosure, the controllable obstacle includes a mesh obstacle.

[0020] According to some embodiments of the disclosure, the device includes a control wire to control deployment of the mesh obstacle.

[0021] According to an aspect of some embodiments of the present disclosure there is provided a method for controlling flow of blood to arteries branching from an aorta, the method including inserting a controllable obstacle into an aorta, and controlling the controllable obstacle to deploy, blocking a portion of a cross section of the aorta, thereby decreasing blood flow downstream of the deployed controllable obstacle, increasing blood pressure upstream of the deployed controllable obstacle, and increasing blood flow to arteries branching from the aorta.

[0022] According to some embodiments of the disclosure, increasing blood flow to arteries branching from the aorta includes increasing blood flow to arteries through a debris blocking mesh.

[0023] According to some embodiments of the disclosure, the controllable obstacle is included in a blood-borne debris blocking device.

[0024] According to some embodiments of the disclosure, controlling the controllable obstacle to deploy includes controlling the controllable obstacle to deploy based on a signal from a monitoring device which detects a patient’s pulse.

[0025] According to some embodiments of the disclosure, controlling the controllable obstacle to deploy includes controlling the controllable obstacle to deploy based on a signal from a monitoring device which detects a patient’s diastole and systole.

[0026] According to some embodiments of the disclosure, the monitoring device is a device selected from a group consisting of a bedside monitor, a blood pressure monitor, and a pulse monitor.

[0027] According to some embodiments of the disclosure, the controlling the controllable obstacle includes deploying the controllable obstacle across a cross section of the aorta, blocking in a range between 25 and 75 percent of a cross section of the aorta.

[0028] According to some embodiments of the disclosure, the controlling the controllable obstacle includes deploying the controllable obstacle across a cross section of the aorta, blocking in a range between 75 and 100 percent of a cross section of the aorta.

[0029] According to some embodiments of the disclosure, the controllable obstacle includes an inflatable balloon.

[0030] According to some embodiments of the disclosure, the deploying includes using a tube to inflate the inflatable balloon.

[0031] According to some embodiments of the disclosure, the deploying includes using a tube to deflate the inflatable balloon.

[0032] According to some embodiments of the disclosure, the controllable obstacle includes a mesh obstacle.

[0033] According to some embodiments of the disclosure, the deploying includes using a control wire to control deployment of the mesh obstacle.

[0034] According to some embodiments of the disclosure, the controlling flow of blood to arteries branching from an aorta includes controlling flow of blood to brain arteries. According to some embodiments of the disclosure, the controlling flow of blood to arteries branching from an aorta includes controlling flow of blood to coronary arteries.

[0035] According to an aspect of some embodiments of the present disclosure there is provided a system for controlling flow of blood to arteries branching from an aorta, the system including a debris blocking device including a mesh for blocking debris from entering arteries branching from the aorta, and a controllable obstacle shaped and sized to deploy across the aorta under external control and impede blood flow downstream along the aorta.

[0036] According to some embodiments of the disclosure, further including a controller for controlling the controllable obstacle to deploy based on a signal from a monitoring device which detects a patient’s pulse.

[0037] According to some embodiments of the disclosure, the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 50 percent of a cross section of the aorta.

[0038] According to some embodiments of the disclosure, the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 100 percent of a cross section of the aorta.

[0039] According to some embodiments of the disclosure, the controllable obstacle includes an inflatable balloon.

[0040] According to some embodiments of the disclosure, the system includes a tube to control inflation and deflation of the inflatable balloon.

[0041] According to some embodiments of the disclosure, the controllable obstacle includes a mesh obstacle.

[0042] According to some embodiments of the disclosure, the system includes a control wire to control deployment of the mesh obstacle.

[0043] According to an aspect of some embodiments of the present disclosure there is provided a device for controlling flow of blood to arteries branching from an aorta, the device including a controllable obstacle shaped and sized to insert into an aorta and to deploy across the aorta within the aorta, under external control and impede blood flow downstream along the aorta.

[0044] According to some embodiments of the disclosure, the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 50 percent of a cross section of the aorta.

[0045] According to some embodiments of the disclosure, the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 100 percent of a cross section of the aorta. According to some embodiments of the disclosure, wherein the controllable obstacle includes an inflatable balloon.

[0046] According to some embodiments of the disclosure, the device includes a tube to control inflation and deflation of the inflatable balloon.

[0047] According to some embodiments of the disclosure, the controllable obstacle includes a mesh obstacle.

[0048] According to some embodiments of the disclosure, the device includes a control wire to control deployment of the mesh obstacle.

[0049] 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 disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the disclosure, 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.

[0050] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0051] Some embodiments of the disclosure 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 disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the disclosure may be practiced.

[0052] In the drawings:

[0053] FIGURE 1A is a simplified line drawing illustration of a debris protection device deployed within an aorta according to an example embodiment;

[0054] FIGURE IB is a simplified line drawing illustration of the debris protection device of Figure 1A, which includes a controllable obstacle according to an example embodiment;

[0055] FIGURE 1C is a simplified line drawing illustration of the debris protection device of Figures 1A and IB, in which the controllable obstacle is shown partially blocking the aorta according to an example embodiment;

[0056] FIGURE ID is a simplified line drawing illustration of the debris protection device of Figures 1A, IB and 1C, in which the controllable obstacle is shown blocking the aorta according to an example embodiment; FIGURE 2A is a simplified line drawing illustration of the debris protection device of Figure 1A, which includes a controllable obstacle according to an example embodiment;

[0057] FIGURE 2B is a simplified line drawing illustration of the debris protection device of Figures 2A, in which the controllable obstacle is shown partially blocking the aorta according to an example embodiment;

[0058] FIGURE 2C is a simplified line drawing illustration of the debris protection device of Figures 2A and 2B, in which the controllable obstacle is shown blocking the aorta according to an example embodiment;

[0059] FIGURE 3 is a simplified line drawing illustration of a debris protection device and a controllable obstacle to an example embodiment;

[0060] FIGURE 4 is a simplified flow chart illustration of a method for controlling flow of blood to arteries branching from an aorta according to an example embodiment;

[0061] FIGURE 5A is a simplified flow chart illustration of a method of reducing damage to the heart during a vascular procedure, and also supplying blood to a heart according to an example embodiment;

[0062] FIGURE 5B is a simplified flow chart illustration of a method for protecting debris from entering a protected organ during a medical procedure, and also supplying blood to the protected organ according to an example embodiment;

[0063] FIGURE 6A is a graph showing a relation between blood flow to a protected organ and an extent of debris capture, according to an example embodiment; and

[0064] FIGURE 6B is a graph showing a relation between blood flow to a protected organ and an extent of obstruction downstream of a debris-protection device, according to an example embodiment.

[0065] DESCRIPTION OF SPECIFIC EMBODIMENTS

[0066] The present disclosure, in some embodiments thereof, relates to devices and methods to protect brain and / or coronary arteries from entry of debris while also maintaining supply of blood to the brain and / or coronary arteries and, more particularly, but not exclusively, during medical procedures.

[0067] Introduction

[0068] Micro emboli, including small particles, may enter the coronary arteries and reach small arterial vessels including the arterioles. Such small particles have a role in a cascade of events in the arterioles, leading to myocardial fibrosis. Myocardial fibrosis is found in post-mortem studies of patients’ hearts who had TA VI before their death, and may have been the reason for sudden death in patients that underwent the TAVI procedure. Micro emboli and other particle types are also part of a myocardial cascade which leads to myocardium tissue inflammation and necrosis in myocardium tissue. A connection was found between atrial fibrillation and cardiac arrhythmia.

[0069] The above provides motivation for protecting brain and / or coronary arteries from bloodborne debris.

[0070] If blood flow to the organs is reduced beyond a certain period of time, the organs may suffer. If blood flow to the brain is reduced beyond a certain period of time, the brain may suffer. If blood flow to the coronary arteries is reduced beyond a certain period of time, the heart may not provide a desired pumping action to provide blood to many organs.

[0071] The above provides motivation for also maintaining some supply of blood to the brain and / or coronary arteries either starting at a same time as starting the protection from debris, or after a period of time from the starting the protection.

[0072] Organs to be protected

[0073] The descriptions herein of an organ to be protected from debris yet also supplied with blood will mention the brain and / or the heart. However, more such organs are contemplated, and wherever the brain and / or the heart are described, the description is intended to include the heart and / or brain and / or other organs also. Some other organs include: kidneys, celiac artery branches - upper GI duct, mesenteric arteries - Mid & Lower GU duct, and abdominal and pelvic organs and limbs.

[0074] Controlling supply of blood to the brain during debris protection mode

[0075] An aspect of some embodiments relates to a device for controlling supply of blood to the brain during debris protection mode blocking debris from entering the brain arteries.

[0076] In some embodiments, during debris protection mode a mesh or filter is used to prevent debris from entering the brain arteries. The mesh or filter may lower the amount of blood reaching the brain.

[0077] In some embodiments, it is desired that more blood reach the brain than reaches the brain when the mesh of filter is deployed without benefit of embodiments described herein.

[0078] In some embodiments, pressure of blood at the filter or the mesh is increased, thereby increasing flow of blood to the brain relative to when the pressure has not been increased.

[0079] In some embodiments, the debris protection device optionally includes an obstacle controllable to partly or fully block downstream blood flow. The obstacle is optionally deployed when it is desired to increase blood flow to the brain. Having an obstacle in the blood flow potentially raises blood pressure upstream of the obstacle, potentially increasing flow of blood to the brain relative to when the obstacle has not been deployed.

[0080] In some embodiments, the obstacle may be controlled to block a portion of a cross section of the descending aorta, such as a portion in a range between 20 percent and up to 50 percent and even 100 percent of the aorta.

[0081] In some embodiments, the obstacle may be controlled to expand to a diameter between 0.5 cm (for a small child) and up to more than 3 cm, even 5-6 cm, for an adult with an enlarged aorta.

[0082] In some embodiments, the debris protection device does not include a controllable obstacle to downstream blood flow. In some embodiments an obstacle which is separate from the debris protection device is optionally located downstream of the debris protection device, and when it is desired to increase blood flow to the brain, the obstacle is deployed. Having an obstacle in the blood flow raises potentially blood pressure upstream of the obstacle, potentially increasing flow of blood to the brain relative to when the obstacle has not been deployed.

[0083] In some embodiments the obstacle, whether as part of the debris protection device or as a separate device, is an inflatable balloon, which may optionally be located downstream of the exits to the brain arteries. When desired, the balloon is optionally inflated to block some or all of the lumen, for example the descending aorta, so as to block at least some blood flow and increase blood pressure upstream of the balloon.

[0084] In some embodiments the obstacle, whether as part of the debris protection device or as a separate device, is a mesh or filter, which may optionally be located downstream of the exits to the brain arteries. The mesh or filter is optionally deployed and / or unfurled to block some or all of the lumen, for example the descending aorta, so as to block at least some blood flow and increase blood pressure upstream of the balloon.

[0085] In some embodiments the obstacle, whether as part of the debris protection device or as a separate device, is a basket shaped mesh or filter, which may optionally be located downstream of the exits to the brain arteries. The basket is optionally deployed and / or unfurled to block some or all of the lumen, for example the descending aorta, so as to block at least some blood flow and increase blood pressure upstream of the balloon.

[0086] It is noted that a technique named REBOA is discussed in medical circles. REBOA, which stands for Resuscitative Endovascular Balloon Occlusion of the Aorta is a new technique designed to stop internal hemorrhage. REBOA involves passing a small inflatable balloon into an aorta to stop the bleeding until a patient can be taken to an operating theatre. While REBOA has shown early promise, it is not yet known whether it is better than the standard care given to trauma patients. It is also noted that the REBOA technique is intended to stop bleeding downstream of an inflated balloon, while methods and device described herein relate to effects which are caused to occur upstream of an inflated balloon, or of some other obstacle to blood flow.

[0087] In some embodiments activation and / or deactivation of the obstacle is performed by a physician from outside a patient’s body, optionally by one or more control wire(s).

[0088] In some embodiments activation and / or deactivation of the debris protection device is performed by a physician from outside a patient’s body, optionally by one or more control wire(s).

[0089] Anchoring the obstacle

[0090] An aspect of some embodiments relates to anchoring the obstacle in place, especially when the obstacle is activated and increases the blood pressure acting upon the obstacle, producing a force pushing the obstacle downstream.

[0091] In some embodiments, the obstacle may be held in place by a wire still enough to prevent the obstacle from being pushed downstream.

[0092] In some embodiments, the obstacle may include a mechanism such as a hook, to mechanically attach the obstacle to a debris trapping device in the aorta, where the debris trapping device is anchored in the aorta.

[0093] In some embodiments, the debris trapping device includes a mesh, and the obstacle includes a surface which attaches to the mesh, where the mesh is anchored in the aorta.

[0094] Timing of blood flow enhancement related to timing of debris protection mode

[0095] An aspect of some embodiments relates to when an obstruction is activated to decrease downstream blood flow and increase blood pressure in the aorta, to increase blood supply to the brain.

[0096] In some embodiments, there is no need to increase blood supply to the brain. It is possible that a cardiac procedure be short enough that using a debris protection device, which potentially limits the amount of blood flowing to the brain, does not adversely affect a patient’s well-being. In such a case, there may be no need to activate an obstruction intended to increase blood pressure in the aorta, to increase blood supply to the brain.

[0097] In some embodiments, the cardiac procedure may last longer than planned, and there may be a need to increase blood supply to the patient’s brain, optionally by activating an obstruction to blood flow in the aorta, in order to increase blood pressure in the aorta, to potentially increase blood supply to the brain. In some embodiments, the cardiac procedure may be planned a priori to be long enough, producing a need to increase blood supply to the patient’s brain, optionally by activating an obstruction to blood flow in the aorta, in order to increase blood pressure in the aorta, to potentially increase blood supply to the brain.

[0098] Some non-limiting example cases where a need to increase blood flow may arise: after TA VI deployment; in case of perfusion with no reflow syndrome; in case where the heart does not return to normal pumping function after a procedure and there is a risk of pressure fall in the blood stream to the BRAIN.

[0099] Increasing blood supply to the brain can be done over a period of time ranging between a few seconds, for example 5 seconds and more, to several minutes, for example up to 5, 10, 15 and up to 30 minutes.

[0100] A non-limiting example of when the increasing blood supply to the brain may be done is during pace down, when there is a burst of blood during the systole. If, during the diastole, there is a case of perfusion with no reflow, the heart is not receiving blood and not recovering as it should. Following systoles may become weaker and weaker, potentially causing low blood flow to the brain. In such a case one may optionally activate the device for increasing blood flow to the brain, optionally even at a cost of reducing blood flow to distal body parts while increasing blood flow to the brain and coronaries.

[0101] In some embodiments, timing of the blood flow enhancement related to timing of heart beats may be performed by a physician from outside a patient’s body. In some embodiments the timing is performed by activation and / or deactivation of the blood flow obstacle.

[0102] In some embodiments the timing is performed by activation and / or deactivation of the debris trapping device, optionally by opening and closing debris traps.

[0103] In some embodiments the timing is performed by activation and / or deactivation of the debris trapping device, optionally by reducing mesh pore size or increasing mesh pore size of a mesh filter for filtering blood flow.

[0104] Pace up, pace down and debris shower

[0105] Some heart procedures include periods called “pace up”, when heart rate is raised relative to normal-for-the-patient heart rate, and “pace down”, when heart rate is lowered back down to normal-for-the-patient.

[0106] During “pace up”, the heart flutters, and does not pump powerfully. There is little blood flow, and with less blood flow comes less debris flow. The “pace down” period typically follow a heart procedure, and may initiate a “debris shower”. The heart procedure may have caused and / or released debris, and when blood returns to being pumped normally by the heart, during a return to “pace down”, the debris appears in large amounts, relative to normal, as a debris shower.

[0107] Synchronization of blood flow enhancement related to timing of heart beats

[0108] During a systole the heart contracts, exerting pressure also on the blood arteries, which, at that time, do not enable entry of blood, or at least greatly limit entry of blood therein. When blood does not enter the coronary arteries, debris is also not swept into the coronary arteries.

[0109] During a diastole the heart expands, and blood may flow into the coronary arteries. At such a time it may be desirable to activate protection of the coronary arteries against incoming debris, and / or to increase protection of the coronary arteries against incoming debris.

[0110] In some embodiments, the activation of protection against debris and / or increased protection against debris are optionally activated just before and during a time when a debris shower is expected.

[0111] In some embodiments, protection of coronary arteries is optionally increased during diastole, by way of some non-limiting examples: by reducing mesh pore size of a mesh protecting the coronary arteries during diastole; and / or by activating a one-way valve which includes a mesh to filer blood - to protect the coronary arteries - as described in above-mentioned International Patent Application No. IL2023 / 050901 by Zeev Brandeis, titled: “Protecting Coronary Arteries and Myocardium Blood Vessels During Medical Procedures”.

[0112] In some embodiments, activating of an obstacle for increasing blood pressure in the aorta, and / or increasing blood flow to the brain, as described herein, may be synchronized with the systole and diastole of the heart.

[0113] In some embodiments, a device which detects the systole and the diastole of the heart may be used to activate and / or deactivate the obstacle, in some example embodiments at a rate correspond to one cycle of activate / deactivate per cycle of the contraction and expansion.

[0114] Some non-limiting examples of such devices for detection of the systole and diastole include: a bedside monitor; a blood pressure monitor; and a pulse monitor.

[0115] By way of a non-limiting example, when systole provides higher blood pressure, obstructing blood flow may optionally be reduced.

[0116] By way of a non-limiting example, when systole provides higher blood pressure, obstructing blood flow may optionally be increased, to increase blood pressure in the aorta and enhance providing blood to organs such as the heart and / or the brain. By way of a non-limiting example, when diastole does not provide higher blood pressure, obstructing blood flow by a controllable obstruction such as an inflatable balloon or another controllable obstruction may optionally be increased, to provide blood to an organ such as the brain, potentially through a debris-protection mesh.

[0117] By way of a non-limiting example, when systole provides higher blood pressure, mesh pore size in debris traps may optionally be reduced.

[0118] By way of a non-limiting example, when diastole does not provide higher blood pressure, mesh pore size in debris traps may optionally be increased, and / or debris traps may be partially or fully de-activated, to let blood flow downstream and less blood flow back into coronary arteries. In some embodiments, such a timing may potentially enable reduction of debris-laden blood flow into the coronary arteries to a degree which may enable not using filter(s) or a one-way valve to specifically block debris from flowing into the coronary arteries.

[0119] Timing of debris blocking

[0120] A debris blocking device may prevent debris from flowing along arteries which branch off the aorta. However, the debris blocking device, and sometimes the debris collected by the debris blocking device, may optionally block some or even all of blood flow to the branching arteries.

[0121] In some example cases, the debris blocking device is activated to block debris during a cardiac procedure, when a heart is placed into a “Pace Up” condition, to beat at a rapid pace but produce relatively low blood pressure. The timing of debris blocking may start prior to performing a cardiac procedure, and continue during the cardiac procedure.

[0122] In some embodiments, the activation is performed when debris is expected to be produced during a medical procedure, for example a medical procedure on the heart.

[0123] In some embodiments, the activation is performed when debris is expected to be released during a medical procedure, for example a medical procedure on the heart.

[0124] In some embodiments, the activation is performed during a specific step of a medical procedure.

[0125] By way of a non-limiting example, when TAVI is performed, there is a step called “pace- up”, or Rapid Ventricular Pacing (RVP). Rapid ventricular pacing (RVP) is a step during TAVR or TAVI which is used for temporary reduction in cardiac output during the procedure.

[0126] During RVP a replacement heart valve is deployed. The deployment can produce and / or release debris.

[0127] In some embodiments, the blocking is performed approximately (simultaneously with or a short time after) pace-up. During such a time the heart is not producing much output, and what output there is may contain debris, and it is potentially beneficial to activate blocking debris from entering the coronary arteries and / or even to activate blocking backflow of blood toward the coronary arteries.

[0128] By way of a non-limiting example, when TAVI is performed, there is a step called “pacedown”, or “stop RVP”, when the heart is paced back down from “pace-up”, and cardiac output goes back up. During such a step there is a danger of a potential “debris storm”, a large amount of debris being produced and / or released and flowing downstream. In some embodiments, and it is potentially beneficial to activate blocking debris from entering the coronary arteries and / or even to activate blocking backflow of blood toward the coronary arteries.

[0129] It is noted that blood supply to the coronary arteries may be considered as being provided by two mechanisms: backflow, provided by elastic aorta walls pushing back on a bloof pulse cause during a systole, and suction, provided by the heart arteries expanding following a contraction of the heart arteries in the heart muscle during systole.

[0130] In some embodiments, the blocking is performed approximately (simultaneously with or even a short time before) pace-down.

[0131] In some embodiments, the activation is optionally performed by a physician as part of a medical procedure, to protect the coronary arteries from debris.

[0132] In some embodiments, the activation is optionally performed automatically based on sensor input(s).

[0133] By way of a non-limiting example, a heart rate sensor may optionally detect pace-up and automatically activate blocking debris from entering the coronary arteries and / or to activate blocking backflow of blood toward the coronary arteries.

[0134] By way of a non-limiting example, a heart rate sensor may optionally detect pace-down and automatically activate blocking debris from entering the coronary arteries and / or to activate blocking backflow of blood toward the coronary arteries.

[0135] In some embodiments, the activation of blocking debris from entering the coronary arteries and / or blocking backflow of blood toward the coronary arteries, may be limited in time.

[0136] In some embodiments, a physician limits the activation to no more than 10 seconds, 20 seconds, 30 seconds, 60 seconds, 90 seconds or 120 seconds.

[0137] In some embodiments, an automatic timer limits the activation to no more than 30 seconds,

[0138] 60 seconds, 90 seconds or 120 seconds. Controlling supply of blood to the brain in combination with control of debris-protection devices

[0139] An aspect of some embodiments relates to controlling supply of blood to the brain by use of an obstacle to blood flow located in an aorta, in conjunction with activation of debris-protection devices.

[0140] In some embodiments, an obstacle to blood flow is located downstream of a debrisprotection device located in the aorta. In some embodiments, a debris-protection device is activated, by way of a non-limiting example by causing pores in a mesh in the debris-protection device to become smaller, in order to protect brain arteries and / or cardiac arteries from debris such as micro-emboli. Making the pores smaller reduces supply of blood to the brain arteries and / or to the coronary arteries. In some embodiments, a physician may decide to force more blood through the debris-protection device by activating the downstream obstacle to blood flow, to block a least some of the path of the blood flow.

[0141] Should the physician decide that more blood should be sent to the brain or coronary arteries, the physician can block more of the path of the blood flow.

[0142] Should the physician decide that enough blood is arriving at the brain or coronary arteries, the physician can block less of the path of the blood flow.

[0143] Should the debris-protection device become clogged by debris, there may be a need for more blood pressure to force blood to the brain or coronary arteries. The physician can decide to increase blockage of the path of the blood flow using the downstream obstacle to blood flow.

[0144] Coronary protection devices operating in conjunction with additional debris-protection devices

[0145] An aspect of some embodiments relates to operating a device for blocking debris from entering the coronary arteries and / or for blocking backflow of blood toward the coronary arteries in conjunction with additional debris-protection devices.

[0146] In some embodiments, the coronary protection device may optionally be used in conjunction with a debris capture device, by way of a non-limiting example such as described in above-mentioned U.S. Provisional Patent Application number 63 / 398,546 by Brandeis.

[0147] In some embodiments, the coronary protection device may optionally be used in conjunction with an aortic protection device for protecting brain arteries, by way of a non-limiting example such as described in above-mentioned International Patent Application Publication Number WO 2019 / 064223 of Brandeis. Coronary protection devices operating in conjunction with additional medical devices

[0148] In the previous section some non-limiting examples of timing of activation of a debris blocking device were described.

[0149] An aspect of some embodiments relates to operating a device for blocking debris from entering the coronary arteries and / or for blocking backflow of blood toward the coronary arteries in conjunction with additional medical devices

[0150] In some embodiments, the coronary protection device extends, in use, to walls of the aorta, leaving a center space or lumen for other medical tools to pass therethrough.

[0151] In some embodiments, the coronary protection device may optionally be configured to be part of medical tools, such as, by way of a non-limiting example, TAVI tools, and slide along the TA VI tool to reach the location of the coronary arteries.

[0152] In some embodiments, the coronary protection device is optionally inserted via an existing delivery system, by way of a non-limiting example a delivery system for TAVI / TAVR.

[0153] In some embodiments, the coronary protection device is configured to slide along an existing TAVI / TAVR delivery system.

[0154] In some embodiments, the coronary protection device may optionally be configured to be part of medical tools, such as, by way of a non-limiting example, TAVI tools, and fixed to a portion of the TAVI tool to reach the location of the coronary arteries.

[0155] Before explaining at least one embodiment of the disclosure in detail, it is to be understood that the disclosure is not necessarily limited in its application to the details set forth in the following description or exemplified by the Examples. The disclosure is capable of other embodiments or of being practiced or carried out in various ways.

[0156] Reference is now made to Figure 1A, which is a simplified line drawing illustration of a debris protection device deployed within an aorta according to an example embodiment.

[0157] Figure 1A shows a section of an aorta, the section extending from a heart-proximal side 102 to a heart-distal side 104, and includes the aortic arch 106.

[0158] Figure 1 A shows a device 108 in the aorta. The device 108 includes a mesh 109 in the aortic arch, and two optional wires 110 112 attached to the device 108. The mesh 109 covers artery exits to the brain, namely the brachiocephalic artery 114, the left common carotid artery 116 and the left subclavian artery 118.

[0159] Reference is now made to Figure IB, which is a simplified line drawing illustration of the debris protection device of Figure 1A, which includes a controllable obstacle according to an example embodiment. Figure IB shows the elements shown in Figure 1A, plus a controllable obstacle 120 downstream of the artery exits to the brain. The controllable obstacle 120 is shown in a state which is hardly blocking downstream flow of blood. It is noted that the controllable obstacle 120 may, in some embodiments, lie along the wall of the aorta and block blood flow even less than may be understood from looking at Figure IB.

[0160] In some embodiments the controllable obstacle 120 may be an inflatable balloon which can be controlled to inflate to extend across some or all of the diameter of the aorta so as to block some or all of the blood flow downstream, potentially increasing blood pressure upstream of the controllable obstacle 120, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0161] In some embodiments the controllable obstacle 120 may be a filter of mesh which can be controlled to unfurl and / or controlled to extend across some or all of the diameter of the aorta so as to block some or all of the blood flow downstream, potentially increasing blood pressure upstream of the controllable obstacle 120, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0162] Reference is now made to Figure 1C, which is a simplified line drawing illustration of the debris protection device of Figures 1A and IB, in which the controllable obstacle is shown partially blocking the aorta according to an example embodiment.

[0163] Figure 1C shows the elements shown in Figures 1 A and IB, where the controllable obstacle 120 is shown in a state which is partly blocking downstream flow of blood, potentially increasing blood pressure upstream of the controllable obstacle 120, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0164] Reference is now made to Figure ID, which is a simplified line drawing illustration of the debris protection device of Figures 1A, IB and 1C, in which the controllable obstacle is shown blocking the aorta according to an example embodiment.

[0165] Figure ID shows the elements shown in Figures 1A, IB and 1C, where the controllable obstacle 120 is shown in a state which is blocking downstream flow of blood, potentially increasing blood pressure upstream of the controllable obstacle 120, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0166] Reference is now made to Figure 2A, which is a simplified line drawing illustration of the debris protection device of Figure 1A, which includes a controllable obstacle according to an example embodiment.

[0167] Figure 2A shows the elements shown in Figure 1A, and an additional separate controllable obstacle 132 downstream of the artery exits to the brain and one or more control wires 134 for controlling the controllable obstacle 132. The controllable obstacle 132 is shown in a state which is hardly blocking downstream flow of blood. It is noted that the controllable obstacle 132 may, in some embodiments, lie along the wall of the aorta and block blood flow even less than may be understood from looking at Figure 2A.

[0168] In some embodiments the controllable obstacle 132 may be an inflatable balloon which can be controlled to inflate to extend across some or all of the diameter of the aorta so as to block some or all of the blood flow downstream, potentially increasing blood pressure upstream of the controllable obstacle 132, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0169] In some embodiments the controllable obstacle 132 may be a filter of mesh which can be controlled to unfurl and / or controlled to extend across some or all of the diameter of the aorta so as to block some or all of the blood flow downstream, potentially increasing blood pressure upstream of the controllable obstacle 120, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0170] Reference is now made to Figure 2B, which is a simplified line drawing illustration of the debris protection device of Figure 2A, in which the controllable obstacle is shown partially blocking the aorta according to an example embodiment.

[0171] Figure 2B shows the elements shown in Figure 2A, where the controllable obstacle 132 is shown in a state which is partly blocking downstream flow of blood, potentially increasing blood pressure upstream of the controllable obstacle 132, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0172] Reference is now made to Figure 2C, which is a simplified line drawing illustration of the debris protection device of Figures 2A and 2B, in which the controllable obstacle is shown blocking the aorta according to an example embodiment.

[0173] Figure 2C shows the elements shown in Figures 2 A and 2B, where the controllable obstacle 132 is shown in a state which is blocking downstream flow of blood, potentially increasing blood pressure upstream of the controllable obstacle 132, and potentially enabling more blood to pass through the mesh of the device 108 toward the brain arteries.

[0174] Reference is now made to Figure 3, which is a simplified line drawing illustration of a debris protection device and a controllable obstacle to an example embodiment.

[0175] Figure 3 shows a section of an aorta, the section extending from a heart-proximal side 312 to a heart-distal side 14, and includes the aortic arch 316. Figure 3 also shows artery exits 318 to the brain. Figure 3 shows a simplified drawing of an example debris capture device 322 in the aorta. The device 322 includes at least one wire 326 attached to the debris capture device 322.

[0176] Figure 3 also shows a simplified drawing of an example controllable obstacle 324 including at least one wire 328 attached to the controllable obstacle 324.

[0177] Figure 3 also shows the wires 326 328 extending along the aorta, and exiting a patient’s body (not shown) to control knobs 330 332. A physician can optionally use the wires 326 328 to control activating the debris capture device 322 and / or the controllable obstacle 324.

[0178] Reference is now made to Figure 4, which is a simplified flow chart illustration of a method for controlling flow of blood to arteries branching from an aorta according to an example embodiment.

[0179] The method of Figure 4 includes: inserting a controllable obstacle into an aorta (302); and controlling the controllable obstacle to deploy, blocking a portion of a cross section of the aorta (304), thereby decreasing blood flow downstream of the deployed controllable obstacle, increasing blood pressure upstream of the deployed controllable obstacle, and increasing blood flow to arteries branching from the aorta.

[0180] Reference is now made to Figure 5A, which is a simplified flow chart illustration of a method of reducing damage to the heart during a vascular procedure, and also supplying blood to a heart according to an example embodiment.

[0181] The method of Figure 5 A includes: identifying a potentially debris-causing event (402); reducing debris carried by backflow from an aorta into a coronary artery during diastole in response to the identifying (404); and deploying an obstacle to blood flow, thereby increasing blood pressure upstream of the obstacle (406) in order to increase blood supply to the heart.

[0182] Reference is now made to Figure 5B, which is a simplified flow chart illustration of a method for protecting debris from entering a protected organ during a medical procedure, and also supplying blood to the protected organ according to an example embodiment.

[0183] The method of Figure 5B includes: inserting a device for protecting debris from entering a protected organ (412); positioning the device to protect debris from entering the protected organ (414); performing the medical procedure (416); and deploying an obstacle to blood flow, thereby increasing blood pressure upstream of the obstacle (418) in order to increase blood supply to the protected organ.

[0184] Reference is now made to Figure 6A, which is a graph showing a relation between blood flow to a protected organ and an extent of debris capture, according to an example embodiment.

[0185] Figure 6A shows a graph with an X axis 502 qualitatively describing an extent of debris capture, from LOW to HIGH, and a Y axis 504 qualitatively describing an amount of blood flow to a protected organ.

[0186] Figure 6A show a line 506 which describes the relation between blood flow to the protected organ and an extent of debris capture.

[0187] The line 506 shows that the more the extent of debris capture, the less blood reaches the protected organ, for example a brain and / or a heart.

[0188] In some embodiments the extent of debris capture may be a size of pores in a mesh in a debris-protection device.

[0189] In some embodiments the extent of debris capture may be an extent in which the pores of a mesh of the debris-protection device are blocked by trapped debris, or, for example, a percentage of in area of the mesh in the debris-protection device which is blocked by debris.

[0190] Reference is now made to Figure 6B, which is a graph showing a relation between blood flow to a protected organ and an extent of obstruction downstream of a debris-protection device, according to an example embodiment.

[0191] Figure 6B shows a graph with an X axis 512 qualitatively describing an extent of obstruction of blood flow downstream of a debris-capture device, from LOW to HIGH, and a Y axis 514 qualitatively describing an amount of blood flow to a protected organ.

[0192] Figure 6B show a line 516 which describes the relation between blood flow to the protected organ and an extent of obstruction of blood flow downstream of a debris-capture device.

[0193] The line 516 shows that the more the extent of obstruction of blood flow downstream of the debris-capture device, the more blood reaches the protected organ, for example a brain and / or a heart.

[0194] In some embodiments, a physician optionally controls both an extent of debris capture, for example by controlling a size of pores of a mesh in a debris-capture device, and an extent of obstruction downstream of the debris-protection device, for example by inflating an obstructive balloon, and / or by deploying a mesh or even a debris trap downstream of the debris-protection device, across some or all of the downstream blood flow path. Exemplary additional technical information

[0195] In some embodiments, the mesh is optionally in a shape of a lumen. In some embodiments the device optionally includes a heart-proximal ring, at a heart-proximal end of the mesh. In some embodiments the heart-proximal ring optionally anchors the device to the aorta, optionally preventing movement of the device along the aorta while other tools or catheter(s) pass through the device. In some embodiments the heart-proximal ring optionally pushes against walls of the aorta in order to anchor the device to the aorta. In some embodiments one or more mesh layers are attached to the heart-proximal ring. In some embodiments the device optionally includes a heart- distal ring, at a heart-distal end of the mesh. In some embodiments, the device is sized and shaped to fit an inside of an aorta of a patient. In some embodiments, the size of the device is selected from a range of sizes, lengths and diameters of the device, to fit patients from small to large. In some embodiments, a length of the aortic protection device is in a range of 100 to 200 to 250 millimeters. In some embodiments the device may optionally be sized and shaped to extend further down the descending thoracic aorta, and even along the abdominal aorta, and reach a length up to 450 millimeters. In some embodiments, the device may optionally be sized and shaped to have a diameter of 20 to 28 to 45 to 70 millimeters, optionally to correspond to a diameter of a patient’s aorta. In some embodiments the device 10 includes a layer of wires including shape memory material, optionally giving the device 10 its shape, when deployed, and one or more layers of mesh with small pores, sized in a range from 30 to 200 microns. In some embodiments, the mesh includes pores of approximately 50 microns in diameter. In some embodiments, the mesh lumen is arranged to change a porosity from pores sized in a range between 200 microns and 100 microns to pores sized in a range between 100 and 50 microns or a range between 100 and 30 microns. In some embodiments, the sizes of the holes of the mesh depend on how much the mesh is stretched, for example by a shape of the shape-memory material. Some non-limiting examples of the layer of shape memory material include a mesh made from shape memory material, a mesh woven and / or braided from shape memory material, and shape memory wires placed parallel to additional layers in the device. Some non-limiting example of shape memory material include: Nitinol; Nitinol alloy; stainless steel; DFT (Drawn Filled Tube) composite wire; cobalt chromium; polymer material such as polymer wire; polymer woven\braided material; a combination of more than one polymer; medical grade metal coated with polymer; optionally in a form of wires\tubes and / or in a braided or laser cut form; thin polymer strings of high strength and flexibility, similar to memory- shaped polymer materials. In some embodiments, a polymer mesh potentially protects the aortic wall and / or calcification of the aortic wall from damage which may be inflicted by stiffer material such as a metal or plastic wire in the device. In some embodiments, the polymer mesh protects the aortic wall by being a softer or more elastic material than the stiffer material. In some embodiments, the polymer mesh is made of a polyurethane material or a carbonated polyurethane material or a derivative of the above-mentioned materials. In some embodiments, the derivative material has same traits and / or characteristics as the polyurethane material or the carbonated polyurethane material. In some embodiments, the polymer mesh is made by injection of the polymer. In some embodiments, the polymer mesh is made by dipping a cylindrical shape or sleeve in the polymer material. In some embodiments, the polymer mesh is made by overcoating a cylindrical shape or sleeve in the polymer material. In some embodiments, the polymer mesh is made by weaving a polymer thread produced by electro- spinning a polymer material. In some embodiments, the thread is electro-spun to a diameter in a range between 10 microns and 1 micron. In some embodiments, the thread is electro-spun to a diameter lower than 1 micron, down to 0.5 micron. In some embodiments, the polymer mesh is made by weaving polymer threads. In some embodiments, the weaving is a directional weaving. In some embodiments, the weaving is a non-directional weaving, or weaving in random directions. In some embodiments, the polymer mesh is made of a smooth material, potentially suitable for sliding along a wall of the aorta. In some embodiments, the polymer mesh is made of a slippery material, potentially suitable for sliding along a wall of the aorta. In some embodiments, the polymer mesh is made of a non-stick or non-adhesive material, potentially suitable for sliding along a wall of the aorta. In some embodiments, the polymer mesh protects the aortic wall by using a weave of the mesh which prevents the stiffer material from touching the aortic wall. In some embodiments, the polymer mesh protects the aortic wall by using a weave of the mesh which enables the mesh to slide along the aortic wall. In some embodiments, an angle between a thread direction of the external side of the mesh and a direction of a longitudinal axis of the mesh lumen when the mesh lumen is deployed is configured to be less than an angle of 5 degrees, 10 degrees, 15 degrees, 20 degrees, 30 degrees, 35 degrees, 40 degrees, or 45 degrees or other angles in that range. In some embodiments, in order to pull out the device, the device is shrunk and inserted into a catheter. In some embodiments, the device is not shrunk into a catheter for extraction form the body.

[0196] It is expected that during the life of a patent maturing from this application many relevant medical procedures will be developed and the scope of the term medical procedures is intended to include all such new technologies a priori.

[0197] As used herein with reference to quantity or value, the term “about” means “within ± 50 % of’.

[0198] The terms “comprising”, “including”, “having” and their conjugates mean “including but not limited to”. The term “consisting of’ is intended to mean “including and limited to”.

[0199] 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.

[0200] As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a unit” or “at least one unit” may include a plurality of units, including combinations thereof.

[0201] The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “example or “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0202] The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the disclosure may include a plurality of “optional” features unless such features conflict.

[0203] Throughout this application, various embodiments of this disclosure may be presented in 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 disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges 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 sub-ranges 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.

[0204] 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. 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

[0205] 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.

[0206] 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.

[0207] It is appreciated that certain features of the disclosure, 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 disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. 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.

[0208] Although the disclosure 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.

[0209] 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. A device for controlling flow of blood to arteries branching from an aorta, the device comprising: a mesh for blocking debris from entering arteries branching from the aorta; and a controllable obstacle shaped and sized to deploy across the aorta under external control and impede blood flow downstream along the aorta.

2. The device according to claim 1, wherein the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 50 percent of a cross section of the aorta.

3. The device according to any one of claims 1-2, wherein the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 100 percent of a cross section of the aorta.

4. The device according to any one of claims 1-3, wherein the controllable obstacle comprises an inflatable balloon.

5. The device according to claim 4, wherein the device comprises a tube to control inflation and deflation of the inflatable balloon.

6. The device according to any one of claims 1-3, wherein the controllable obstacle comprises a mesh obstacle.

7. The device according to claim 6, wherein the device comprises a control wire to control deployment of the mesh obstacle.

8. A method for controlling flow of blood to arteries branching from an aorta, the method comprising: inserting a controllable obstacle into an aorta; and controlling the controllable obstacle to deploy, blocking a portion of a cross section of the aorta, thereby decreasing blood flow downstream of the deployed controllable obstacle, increasingblood pressure upstream of the deployed controllable obstacle, and increasing blood flow to arteries branching from the aorta.

9. The method according to claim 8, wherein increasing blood flow to arteries branching from the aorta comprises increasing blood flow to arteries through a debris blocking mesh.

10. The method according to any one of claims 8-9, wherein the controllable obstacle is comprised in a blood-borne debris blocking device.

11. The method according to any one of claims 8-10, wherein controlling the controllable obstacle to deploy comprises controlling the controllable obstacle to deploy based on a signal from a monitoring device which detects a patient’s pulse.

12. The method according to any one of claims 8-10, wherein controlling the controllable obstacle to deploy comprises controlling the controllable obstacle to deploy based on a signal from a monitoring device which detects a patient’s diastole and systole.

13. The method according to any one of claims 11-12, wherein the monitoring device is a device selected from a group consisting of: a bedside monitor; a blood pressure monitor; and a pulse monitor.

14. The method according to any one of claims 8-10, wherein the controlling the controllable obstacle comprises deploying the controllable obstacle across a cross section of the aorta, blocking in a range between 25 and 75 percent of a cross section of the aorta.

15. The method according to any one of claims 8-14, wherein the controlling the controllable obstacle comprises deploying the controllable obstacle across a cross section of the aorta, blocking in a range between 75 and 100 percent of a cross section of the aorta.

16. The method according to any one of claims 8-15, wherein the controllable obstacle comprises an inflatable balloon.

17. The method according to claim 16, wherein the deploying comprises using a tube to inflate the inflatable balloon.

18. The method according to claim 16, wherein the deploying comprises using a tube to deflate the inflatable balloon.

19. The method according to any one of claims 8-15, wherein the controllable obstacle comprises a mesh obstacle.

20. The method according to claim 19, wherein the deploying comprises using a control wire to control deployment of the mesh obstacle.

21. The method according to any one of claims 8-20, wherein the controlling flow of blood to arteries branching from an aorta comprises controlling flow of blood to brain arteries.

22. The method according to any one of claims 8-21, wherein the controlling flow of blood to arteries branching from an aorta comprises controlling flow of blood to coronary arteries.

23. A system for controlling flow of blood to arteries branching from an aorta, the system comprising: a debris blocking device comprising a mesh for blocking debris from entering arteries branching from the aorta; and a controllable obstacle shaped and sized to deploy across the aorta under external control and impede blood flow downstream along the aorta.

24. The system according to claim 23, and further comprising a controller for controlling the controllable obstacle to deploy based on a signal from a monitoring device which detects a patient’s pulse.

25. The system according to claim 23, wherein the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 50 percent of a cross section of the aorta.

26. The system according to any one of claims 23-25, wherein the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 100 percent of a cross section of the aorta.

27. The system according to any one of claims 23-26, wherein the controllable obstacle comprises an inflatable balloon.

28. The system according to claim 27, wherein the system comprises a tube to control inflation and deflation of the inflatable balloon.

29. The system according to any one of claims 23-26, wherein the controllable obstacle comprises a mesh obstacle.

30. The system according to claim 29, wherein the system comprises a control wire to control deployment of the mesh obstacle.

31. A device for controlling flow of blood to arteries branching from an aorta, the device comprising a controllable obstacle shaped and sized to insert into an aorta and to deploy across the aorta within the aorta, under external control and impede blood flow downstream along the aorta.

32. The device according to claim 31, wherein the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 50 percent of a cross section of the aorta.

33. The device according to any one of claims 31-32, wherein the controllable obstacle is shaped and sized to deploy across a cross section of the aorta blocking up to 100 percent of a cross section of the aorta.

34. The device according to any one of claims 31-33, wherein the controllable obstacle comprises an inflatable balloon.

35. The device according to claim 34, wherein the device comprises a tube to control inflation and deflation of the inflatable balloon.

36. The device according to any one of claims 31-33, wherein the controllable obstacle comprises a mesh obstacle.

37. The device according to claim 36, wherein the device comprises a control wire to control deployment of the mesh obstacle.

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