Protection of coronary arteries and myocardial vessels during medical procedures

Abstract

A device for protecting coronary arteries from debris intrusion, comprising an expandable frame and a debris-blocking barrier, the expandable frame shaped and sized to expand against the wall of the ascending aorta. A method for reducing damage to the heart during a vascular procedure, comprising identifying an event that may generate debris and, in response to the identification, reducing debris carried by backflow from the aorta to the coronary arteries during diastole. A method for protecting coronary arteries from debris intrusion during a medical procedure, comprising inserting a device for protecting coronary arteries from debris intrusion into a patient's aorta, positioning the device to protect the coronary arteries from debris intrusion, and performing a medical procedure on the patient's heart. Related apparatus and methods are also described.

Description

[Technical Field]

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 63 / 400,771, filed August 25, 2022, entitled "Protection of Coronary Arteries and Myocardial Vascular Vessels During Medical Procedures," U.S. Provisional Application No. 63 / 400,773, filed August 25, 2022, entitled "Management of Debris Protection Associated with Vascular or Cardiac Medical Procedures," and U.S. Provisional Application No. 63 / 400,779, filed August 25, 2022, entitled "Anchoring of a Debris Protection Device Within a Body Lumen."

[0002] This application is also a continuation-in-part (CIP) of PCT Patent Application No. PCT / IL2023 / 050875, having an international filing date of August 17, 2023, and claims priority to U.S. Provisional Application No. 63 / 398,546, filed August 17, 2022, entitled "Trapping Flowing Debris Within Blood Vessels and Other Body Lumens."

[0003] The contents of all of the above applications are incorporated by reference as if fully set forth herein.

[0004] Technical Field The present disclosure, in some embodiments thereof, relates to devices and methods for protecting coronary arteries from debris intrusion, and more particularly, but not exclusively, to devices and methods for protecting coronary arteries from debris intrusion during medical procedures. [Background technology]

[0005] Blood-borne debris such as emboli, calcified particles, plaque and detached plaque particles, tissue particles (myocardial tissue, endothelial tissue, etc.), particles from foreign bodies (metals, polymers, etc.) are potentially dangerous and can cause illness, injury, and pathological events that require medical treatment.

[0006] For example, in transcatheter aortic valve implantation (TAVI), diffusion-weighted magnetic resonance imaging (DWI or DW-MRI) has found particles in the brain in 99% of patients. The amount of debris associated with the vascular bed (valve tissue, arterial wall, and calcification) was significantly higher. Additional particles included atherosclerotic plaque, myocardial tissue, endothelial tissue, and foreign particles of unknown origin, such as polymers and gas bubbles and / or gas bubbles. The source of these particles is likely the left ventricle and the area where TAVI was performed. Of particular concern are microemboli, i.e., small particles ranging from 150 to 120 microns, and even 50 to 30 microns in size. Microembolic particles are suspected to have a tendency to migrate to and become embedded in arterioles.

[0007] Additional background art includes the following:

[0008] International Patent Application Publication No. WO2019 / 064223 to Brandeis describes an aortic protection device comprising a mesh lumen shaped and sized to extend along the aorta from the cardiac side of the brachiocephalic artery's exit from the aorta to distal to the left subclavian artery's exit from the aorta, the mesh lumen being arranged to change the porosity of the mesh pores in response to an external control.

[0009] The disclosures of all documents mentioned above and throughout the specification, and of all documents cited within those documents, are hereby incorporated by reference. Summary of the Invention

[0010] The present disclosure, in some embodiments thereof, relates to devices and methods for protecting the coronary arteries and cardiovascular system, such as cardiac arteries, from debris, and more particularly, but not exclusively, to devices and methods for protecting the coronary arteries and cardiovascular system from debris intrusion during medical procedures.

[0011] According to an aspect of some embodiments of the present disclosure, there is provided a device for protecting a coronary artery from debris intrusion, the device comprising: an expandable frame; and a debris-blocking barrier, the expandable frame shaped and sized to expand against a wall of the ascending aorta.

[0012] According to some embodiments of the present disclosure, the debris blocking barrier includes a solid portion of the frame at the entrance to the coronary artery, allowing the frame to block blood flow to the coronary artery when expanded.

[0013] According to some embodiments of the present disclosure, the debris blocking barrier includes an inflatable balloon having a hollow cylindrical shape, shaped and sized to press against the wall of the aorta when inflated and block blood flow to the coronary artery.

[0014] According to some embodiments of the present disclosure, the balloon includes flexible protrusions shaped and sized to maintain a flow path for blood to flow around the balloon when the balloon is uninflated.

[0015] According to some embodiments of the present disclosure, the debris blocking barrier includes a mesh having pores sized to prevent the passage of particles larger than 30 microns ± 10 microns, the mesh attached to the frame, and when the frame is expanded against the wall of the ascending aorta at the exit to the coronary artery, the mesh filters blood entering the coronary artery.

[0016] According to some embodiments of the present disclosure, the mesh is designed such that the pore size of the mesh can be controllably varied.

[0017] According to some embodiments of the present disclosure, the device includes wires for controlling the pore size of the mesh, the wires being sized to extend outside the patient's body.

[0018] According to some embodiments of the present disclosure, the mesh is designed to vary the pore size from a range of 120-150 microns to a range of 30-50 microns.

[0019] According to some embodiments of the present disclosure, the mesh is designed to be completely closed.

[0020] According to some embodiments of the present disclosure, the debris blocking barrier comprises a one-way barrier shaped and sized to prevent particles from being pushed back upstream towards the coronary arteries of the heart during diastole.

[0021] According to some embodiments of the present disclosure, the one-way barrier includes a one-way valve.

[0022] According to some embodiments of the present disclosure, the one-way barrier comprises a flap that allows downstream flow and blocks upstream flow.

[0023] According to some embodiments of the present disclosure, the one-way barrier includes a mesh that prevents the upstream flow of debris.

[0024] According to some embodiments of the present disclosure, a control wire is provided for controlling activation and deactivation of the one-way barrier.

[0025] According to some embodiments of the present disclosure, the one-way barrier includes a flap that extends across the aorta and is swept away by blood when the blood attempts to flow backward upstream during diastole, thereby blocking the backward flow of blood.

[0026] According to some embodiments of the present disclosure, the one-way barrier includes a mesh flap that extends across the aorta and is swept away by blood as the blood attempts to flow backward upstream during diastole, thereby blocking the backward flow of debris while allowing at least a portion of the blood to flow backward.

[0027] According to some embodiments of the present disclosure, the one-way barrier includes both an impermeable flap and a mesh flap extending across the aorta that are swept away by blood as it attempts to flow backward upstream during diastole, the impermeable flap preventing the backward flow of blood and the mesh flap allowing at least some blood to flow backward.

[0028] According to some embodiments of the present disclosure, the impermeable flap and the mesh flap are independently controllable.

[0029] According to some embodiments of the present disclosure, the barrier is designed to be activatable to change from a state that prevents particles from being pushed upstream during diastole to a state that does not prevent particles from being pushed upstream during systole.

[0030] According to some embodiments of the present disclosure, the barrier includes a radiopaque marker to enable detection of whether it is enabled to block.

[0031] According to some embodiments of the present disclosure, the device includes a combination of multiple types of debris blocking barriers.

[0032] According to some embodiments of the present disclosure, the device is configured to be integrated with a TAVI / TAVR delivery system.

[0033] According to some embodiments of the present disclosure, the device is configured to slide along a TAVI / TAVR guidewire.

[0034] According to some embodiments of the present disclosure, the device is configured to be integrated with a Cerebral Embolic Protection (CEP) or Embolic Protection Device (EPD).

[0035] According to some embodiments of the present disclosure, the frame comprises a shape memory alloy.

[0036] According to some embodiments of the present disclosure, the frame comprises a polymer.

[0037] According to some embodiments of the present disclosure, the device is configured to allow a medical instrument to pass along and upstream of the device when placed in the aorta.

[0038] According to some embodiments of the present disclosure, the device is configured to enter a patient's body together with medical instruments for performing surgery on the heart.

[0039] According to some embodiments of the present disclosure, the frame is configured such that expansion of the frame against the wall of the aorta anchors the device and resists movement along the direction of blood flow.

[0040] According to an aspect of some embodiments of the present disclosure, there is provided a method of reducing damage to the heart during a vascular procedure, the method including identifying events that may generate debris, and in response to said identification, reducing debris carried by backflow from the aorta to the coronary arteries during diastole.

[0041] According to some embodiments of the present disclosure, the identifying includes identifying a prosthesis positioning step performed in a prosthesis implant procedure.

[0042] According to some embodiments of the present disclosure, the identifying includes identifying a prosthesis repositioning step to be performed in the prosthesis implant procedure.

[0043] According to some embodiments of the present disclosure, the identifying includes identifying a pace-up step to be performed in the prosthetic implant procedure.

[0044] According to some embodiments of the present disclosure, the identifying includes identifying a slowdown step to be performed in the prosthetic implant procedure.

[0045] According to some embodiments of the present disclosure, the identifying includes identifying a balloon inflation step performed in a prosthetic implant procedure.

[0046] According to some embodiments of the present disclosure, reducing the debris includes blocking blood flow into a coronary artery.

[0047] According to some embodiments of the present disclosure, reducing the debris includes filtering blood entering the coronary arteries.

[0048] According to some embodiments of the present disclosure, reducing the debris includes enabling a one-way valve that prevents backflow of blood from the aorta to the coronary arteries.

[0049] According to some embodiments of the present disclosure, reducing the debris includes enabling a one-way filter that prevents backflow of blood from the aorta into the coronary arteries.

[0050] According to an aspect of some embodiments of the present disclosure, there is provided a method of protecting a coronary artery from debris intrusion during a medical procedure, the method including inserting a coronary artery protecting device from debris intrusion into a patient's aorta, positioning the device to protect the coronary artery from debris intrusion, and performing the medical procedure on the patient's heart.

[0051] According to some embodiments of the present disclosure, the inserting includes inserting via femoral access.

[0052] According to some embodiments of the present disclosure, the inserting includes inserting via radial access.

[0053] According to some embodiments of the present disclosure, the inserting includes inserting via surgical access.

[0054] According to some embodiments of the present disclosure, the inserting includes inserting by hybrid access, which is a combination of surgical access and catheter insertion.

[0055] According to some embodiments of the present disclosure, the method further includes removing the device from the body.

[0056] According to some embodiments of the present disclosure, the method further includes enabling the device to protect the coronary artery from debris intrusion during the medical procedure.

[0057] According to some embodiments of the present disclosure, enabling to protect the coronary arteries from debris intrusion is performed in conjunction with pacing the patient's heart.

[0058] According to some embodiments of the present disclosure, enabling to protect the coronary arteries from debris intrusion is performed in conjunction with pacing down the patient's heart.

[0059] According to some embodiments of the present disclosure, the device is inserted along with an instrument for performing a cardiac procedure.

[0060] According to some embodiments of the present disclosure, the device is inserted before an instrument for performing a cardiac procedure.

[0061] According to some embodiments of the present disclosure, the device is inserted after an instrument for performing a cardiac procedure.

[0062] According to some embodiments of the present disclosure, the device comprises a frame sized and shaped to have a solid wall at the exit to the coronary artery, and the enabling includes controlling the frame to expand against the wall of the ascending aorta so that the solid wall of the frame blocks blood flow to the exit to the coronary artery.

[0063] According to some embodiments of the present disclosure, the device comprises a frame sized and shaped to have a hole arrangement at the exit to the coronary artery, and the enabling includes controlling the frame to expand against the wall of the ascending aorta so that the holes in the frame block the flow of particles to the exit to the coronary artery.

[0064] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this disclosure belongs.Although methods and materials similar or equivalent to those described herein can be used to practice or test the embodiments of this disclosure, exemplary methods and / or materials are described below.In case of conflict, the patent specification, including definitions, shall prevail.In addition, materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting.

[0065] Several embodiments of the present disclosure are described herein, by way of example only, with reference to the accompanying drawings. It is emphasized that the details shown below, with particular reference to the drawings, are for purposes of illustration and for purposes of detailed description of embodiments of the present disclosure. Similarly, from viewing the description in conjunction with the drawings, it will become apparent to those skilled in the art how embodiments of the present disclosure may be practiced. [Brief explanation of the drawings]

[0066] [Figure 1A] 1 is a simplified diagram of the human aorta. [Figure 1B] 1 is a simplified diagram of the human aorta. [Figure 2A] 1 is a simplified diagram of a device for preventing backflow of blood according to an exemplary embodiment. [Figure 2B] 1 is a simplified diagram of a device for preventing backflow of blood according to an exemplary embodiment. [Figure 2C] 1 is a simplified diagram of a device for preventing blood from entering a coronary artery according to an exemplary embodiment. [Figure 2D] 1 is a simplified diagram of a device for preventing blood from entering a coronary artery according to an exemplary embodiment. [Figure 2E] 1 is a simplified diagram of a device for preventing blood from entering a coronary artery according to an exemplary embodiment. [Figure 2F] 1 is a simplified diagrammatic view of a device for preventing backflow of debris according to an exemplary embodiment; [Figure 3A] 1 is a simplified diagram of a coronary protection device positioned in an aorta together with a debris protection device that prevents debris from entering a cerebral artery, according to an exemplary embodiment. [Figure 3B] 1 is a simplified diagrammatic view of a coronary protection device positioned in an aorta together with a debris capture device, according to an exemplary embodiment. [Figure 3C] 1 is a simplified diagram of a coronary protection device positioned in the aorta together with a debris capture device and an aortic protection device, according to an exemplary embodiment. [Figure 3D]1 is a simplified diagram of a coronary protection device positioned in the aorta together with a debris capture device and an aortic protection device, according to an exemplary embodiment. [Figure 4A] FIG. 1 is a simplified flowchart diagram of a method for reducing damage to the heart during a vascular procedure, according to an exemplary embodiment. [Figure 4B] FIG. 1 is a simplified flowchart diagram of a method for protecting coronary arteries from debris intrusion during a medical procedure according to an exemplary embodiment. [Figure 5A] FIG. 1 is a simplified flowchart diagram of a method for preventing backflow of blood into a coronary artery during a medical procedure according to an exemplary embodiment. [Figure 5B] FIG. 1 is a simplified flowchart diagram of a method for protecting coronary arteries from particle intrusion during a medical procedure, according to an exemplary embodiment. [Figure 6A] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. [Figure 6B] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. [Figure 6C] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. [Figure 6D] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. [Figure 6E] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. [Figure 6F] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. [Figure 6G] 1 is a simplified diagrammatic view of a device for protecting a coronary artery according to an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0067] The present disclosure, in some embodiments thereof, relates to devices and methods for protecting coronary arteries from debris intrusion, and more particularly to devices and methods for protecting coronary arteries from debris intrusion during medical procedures.

[0068] introduction

[0069] Microemboli containing small particles can enter coronary arteries and reach small arterial vessels, including arterioles. These small particles are involved in a chain of events in the arterioles, leading to myocardial fibrosis. Myocardial fibrosis has been observed in postmortem studies of the hearts of patients who underwent TAVI before death and may have been the cause of sudden death in patients who underwent TAVI surgery. Microemboli and other particle types are also part of the myocardial cascade, which causes inflammation and necrosis of myocardial tissue. An association has been found between atrial fibrillation and cardiac arrhythmias.

[0070] To better understand some embodiments of the present disclosure, reference is first made to the typical blood flow behavior shown in FIGS. 1A and 1B.

[0071] 1A and 1B are simplified diagrams of the human aorta.

[0072] FIG. 1A is intended to show the aorta in diastole, and FIG. 1B is intended to show the aorta in systole.

[0073] First, details regarding the blood vessels are provided. Figures 1A and 1B show the aorta 102 and the following arteries branching off from the aorta: coronary arteries 104, brachiocephalic artery 108 (often clinically referred to as the innominate artery), left common carotid artery 110, and left subclavian artery 112. Portions of the aorta 102 are labeled the ascending aorta 106A, the aortic arch 106B, and the descending aorta 106C.

[0074] FIG. 1A shows blood 114 flowing downstream along the aorta during diastole and blood 116 flowing into the coronary arteries 104.

[0075] FIG. 1B shows blood 118 flowing downstream during systole, blood flowing back upstream, and blood 120 flowing into the coronary artery 104.

[0076] The walls of the aorta are relatively flexible. During diastole, relatively high-pressure blood leaves the heart, causing the aorta to expand. During systole, the aorta compresses, forcing more blood downstream, but also allowing blood to flow backward, as indicated by the double-headed arrow 118 in Figure 1B.

[0077] overview

[0078] The backflow can cause debris that has passed through the entrance of the coronary artery 104 to flow back into the coronary artery.

[0079] It is desirable to prevent reflux debris from entering the coronary arteries.

[0080] It is noted that the amount of blood reaching the coronary vasculature during diastole is significantly greater in volume than during systole, because the arteries are constricted during systole, reducing their volume.

[0081] Generally, it is desirable to prevent blood-borne debris from entering the coronary arteries during both diastole (backflow) and systole.

[0082] The Windkessel effect is a term used in medicine to describe the shape of the arterial blood pressure waveform based on the interaction of stroke volume, compliance of the aorta and large elastic arteries (Windkessel vessels), and resistance of small arteries and arterioles.

[0083] It is noted that during medical procedures, particularly cardiac procedures, debris may be released or generated. Some of the debris may flow into the coronary arteries, posing a potential risk. It is desirable to prevent debris from entering the coronary arteries.

[0084] Throughout this specification and claims, the term "debris" is used to include thrombi, emboli, microemboli, calcified particles, body tissue particles, myocardial tissue particles, polymer particles, polymer microparticles, foreign body particles within the body lumen, endothelial tissue particles, unorganized thrombi, organized thrombi, plaque particles, particles in the bloodstream, and other undesirable particles found in bodily fluids. The term "debris" also includes stones of various bodily origin (i.e., kidney stones, gallbladder stones, spleen stones, pancreatic stones, etc.).

[0085] Coronary artery protection device that blocks backflow of debris

[0086] An aspect of some embodiments relates to a device for blocking the backflow of debris from the aorta into the coronary arteries.

[0087] Preventing backflow can reduce the amount of blood reaching the heart through the coronary arteries. However, the volume of blood reaching the coronary vasculature during diastole is significantly greater than during systole. This is because the arteries compress and their volume decreases during systole. The heart can tolerate this reduction in blood flow to the coronary vasculature for a short period of time. As a non-limiting example, the duration of this short period may be equivalent to the duration of the rapid ventricular pacing (RVP) step, or "pace-up" step, in a TAVI procedure. During this step, the patient's pulse rate increases to the point of tachycardia, resulting in little or no blood supply to the heart and brain.

[0088] Preventing backflow can almost completely reduce the amount of blood reaching the heart through the coronary arteries. In some embodiments, enabling backflow prevention is optional and occurs during specific time periods, as described below.

[0089] A non-limiting exemplary embodiment of such a device is a device such as, by way of non-limiting example, an expandable frame shaped and sized to deploy a one-way barrier shaped and sized to prevent particles from being pushed back upstream towards the coronary arteries of the heart during diastole.

[0090] A non-limiting exemplary embodiment of such a device is a device such as, by way of non-limiting example, an expandable frame shaped and sized to deploy a one-way valve shaped and sized to prevent particles from being pushed back upstream towards the coronary arteries of the heart during diastole.

[0091] In some embodiments, the unilateral valve optionally includes flexible leaflets that prevent backflow of blood.

[0092] In some embodiments, the flexible leaflets are non-permeable leaflets.

[0093] In some embodiments, the flexible leaflets are mesh leaflets with pore sizes configured to prevent the backflow of debris of a particular size while allowing the backflow of blood without such debris.

[0094] In some embodiments, the one-way barrier or unidirectional valve is optionally configured to be controlled to enable one-way blocking or filtering or to disable blocking / filtering.

[0095] In some embodiments, the device for preventing reflux optionally includes a debris trap. In some embodiments, the debris trap can optionally be opened and / or closed by control from outside the patient's body. In some embodiments, the debris trap can optionally be closed prior to removal from the patient's body, allowing trapped debris to be removed from the patient's body.

[0096] In some embodiments, the device for blocking the reflux of debris is shaped and sized to be delivered through a catheter ranging in size from 5 to 8 French.

[0097] Coronary artery protection device that blocks debris from entering the coronary arteries

[0098] An aspect of some embodiments relates to a device that blocks the entry of debris into a coronary artery.

[0099] A non-limiting exemplary embodiment of such a device is an expandable frame shaped and sized to expand against the wall of the ascending aorta at the ostium of the coronary artery, the frame including a solid wall at the ostium of the coronary artery, allowing the frame to block blood flow to the coronary artery when expanded, optionally for a specific period of time as described below.

[0100] One non-limiting example of such a device is an inflatable balloon shaped and sized to expand against the wall of the ascending aorta at the ostium of a coronary artery, occluding the ostium and blocking blood flow to the coronary artery upon inflation, optionally at specific times as described below.

[0101] One non-limiting example of an embodiment of such a device is, by way of non-limiting example, an expandable frame-like device shaped and sized to place a mesh at the entrance to a coronary artery, which when activated can prevent debris above a certain size, such as the pore size of the mesh, from entering the coronary artery. In some embodiments, activation can optionally occur at a specific time, as described below.

[0102] As noted above, filtration at the entrance to the coronary arteries is particularly relevant during diastole, when more blood typically flows into the coronary arteries.

[0103] In some embodiments, the debris-blocking device may optionally include a debris trap. In some embodiments, the debris trap may optionally be opened and / or closed by control from outside the patient's body. In some embodiments, the debris trap may optionally be closed prior to removal from the patient's body, allowing trapped debris to be removed from the patient's body.

[0104] In some embodiments, the device for blocking the entry of debris into the coronary arteries is shaped and sized to be delivered through a catheter in the range of 5 to 8 French.

[0105] Timing of shutdown

[0106] An aspect of some embodiments relates to the timing at which the device is enabled to block the inflow of debris into the coronary arteries and / or block the backflow of blood into the coronary arteries.

[0107] In some embodiments, the activation occurs when debris is expected to be generated during a medical procedure, such as a cardiac medical procedure.

[0108] In some embodiments, the activation occurs when debris is expected to be released during a medical procedure, such as a cardiac medical procedure.

[0109] In some embodiments, the validation occurs during a specific step of the medical procedure.

[0110] As a non-limiting example, when TAVI is performed, there is a step called "pace up" or rapid ventricular pacing (RVP), which is a step used to temporarily reduce cardiac output during TAVR or TAVI.

[0111] During RVP, a replacement heart valve is deployed, which may generate and / or release debris.

[0112] In some embodiments, the blockage occurs approximately simultaneously with (or a short time after) the pace-up. During these times, the heart is not producing much output, and the output may include debris, so it is potentially beneficial to enable blockage of debris from entering the coronary arteries and / or even enable blockage of blood from flowing back into the coronary arteries.

[0113] As a non-limiting example, when TAVI is performed, there is a step called "pacing down" or "RVP arrest," in which the heart is slowed down from "pacing up" and cardiac output is increased again. During such a step, large amounts of debris are generated and / or released, risking a "debris storm" that flows downstream. In some embodiments, it is potentially beneficial to enable blocking of debris inflow into the coronary arteries and / or even to enable blocking of backflow of blood into the coronary arteries.

[0114] In some embodiments, the shutoff occurs approximately simultaneously with (or a short time before) the pace down.

[0115] In some embodiments, activation is optionally performed by a physician as part of a medical procedure to protect coronary arteries from debris.

[0116] In some embodiments, activation may optionally occur automatically based on sensor input.

[0117] As a non-limiting example, a heart rate sensor may optionally detect a pace up and automatically enable blocking of debris inflow into the coronary arteries and / or even blocking backflow of blood into the coronary arteries.

[0118] As a non-limiting example, a heart rate sensor may optionally detect a slowdown and automatically enable blocking of debris flow into the coronary arteries and / or even blocking backflow of blood into the coronary arteries.

[0119] In some embodiments, the effectiveness of blocking the inflow of debris into the coronary arteries and / or even blocking the backflow of blood into the coronary arteries may be limited in time.

[0120] In some embodiments, the physician limits activation to no more than 10 seconds, 20 seconds, 30 seconds, 60 seconds, 90 seconds, or 120 seconds.

[0121] In some embodiments, an automatic timer limits activation to no more than 30 seconds, 60 seconds, 90 seconds, or 120 seconds.

[0122] Coronary protection device working in conjunction with additional debris protection devices

[0123] An aspect of some embodiments relates to a device for blocking the inflow of debris into a coronary artery and / or blocking the backflow of blood into a coronary artery operating in conjunction with an additional debris protection device.

[0124] In some embodiments, the coronary artery protection device may optionally be used in conjunction with a debris capture device (such as, by way of non-limiting example, a debris capture device such as that described in U.S. Provisional Patent Application No. 63 / 398,546 by Brandeis, supra).

[0125] In some embodiments, the coronary artery protection device may optionally be used in conjunction with an aortic protection device to protect cerebral arteries (such as, by way of non-limiting example, an aortic protection device as described in International Patent Application Publication No. WO 2019 / 064223 by Brandeis, supra).

[0126] Coronary protection devices that work in conjunction with additional medical equipment

[0127] An aspect of some embodiments relates to operating a device for blocking the inflow of debris into a coronary artery and / or blocking the backflow of blood into a coronary artery in conjunction with additional medical equipment.

[0128] In some embodiments, the coronary protection device extends to the wall of the aorta in use, leaving a central space or lumen for other medical instruments to pass through.

[0129] In some embodiments, the coronary artery protection device may optionally be configured as part of a medical instrument, such as, but not limited to, a TAVI instrument, and may slide along the TAVI instrument to reach the location of the coronary arteries.

[0130] In some embodiments, the coronary protection device is optionally inserted via an existing delivery system (for example, but not limited to, a delivery system for TAVI / TAVR).

[0131] In some embodiments, the coronary protection device is configured to slide along an existing TAVI / TAVR delivery system.

[0132] In some embodiments, the coronary artery protection device may optionally be configured as part of a medical instrument, such as, but not limited to, a TAVI instrument, and may be fixed to a portion of the TAVI instrument to reach the location of the coronary arteries.

[0133] Before describing at least one embodiment of the present disclosure in detail, it is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of elements and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0134] Before describing at least one embodiment of the present disclosure in detail, it is to be understood that the present disclosure is not limited to the details set forth in the following description or illustrated by way of example. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0135] Reference is made to FIG. 2A, which is a simplified diagrammatic illustration of a device for preventing backflow of blood, according to an exemplary embodiment.

[0136] FIG. 2A is intended to show a device that operates as a one-way flow valve.

[0137] 2A shows the aorta 102 and the arteries that branch off from it: the coronary arteries 104, the brachiocephalic artery 108, the left common carotid artery 110, and the left subclavian artery 112. Portions of the aorta 102 are shown: the ascending aorta 106A, the aortic arch 106B, and the descending aorta 106C.

[0138] FIG. 2A shows a device 202 for preventing backflow of blood located immediately downstream of a coronary artery 104 .

[0139] FIG. 2A shows a device 202 including a one-way valve including leaflets 204 configured to prevent the backflow of blood.

[0140] In some embodiments, the leaflets 204 are flexible, allowing a medical device (not shown) to pass between them, and when the leaflets are activated to block backflow, the leaflets 204 can fit tightly against the medical device, blocking the space between the leaflets 204 and the medical device and blocking the backflow of blood.

[0141] Reference is now made to FIG. 2B, which is a simplified diagrammatic illustration of a device for preventing backflow of blood, according to an exemplary embodiment.

[0142] FIG. 2B is intended to show the device operating as a one-way filtration valve.

[0143] 2B shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 are shown (ascending aorta 106A, aortic arch 106B, and descending aorta 106C).

[0144] FIG. 2B shows a device 212 for preventing backflow of blood located immediately downstream of the coronary artery 104.

[0145] FIG. 2B shows a device 212 that includes a one-way valve that includes leaflets 214 configured to prevent the backflow of blood.

[0146] In some embodiments, the leaflets 214 are flexible and include a mesh that filters backflowing blood, prevents backflow of debris particles, and allows backflow of blood.

[0147] In some embodiments, the mesh pore size is selected in the range of 120 to 30 microns.

[0148] Reference is now made to FIG. 2C, which is a simplified diagrammatic illustration of a device for preventing blood flow into a coronary artery, according to an exemplary embodiment.

[0149] FIG. 2C is intended to show a device that blocks blood flow into a coronary artery.

[0150] 2C shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 are shown (ascending aorta 106A, aortic arch 106B, and descending aorta 106C).

[0151] FIG. 2C shows a device 222 that prevents blood from entering the coronary artery 104 .

[0152] FIG. 2C shows a device 222 (e.g., an expandable frame 222 shaped and sized to expand against the wall of the ascending aorta at the exit of the coronary artery), the frame including a solid wall at least at the entrance of the coronary artery 104, which can block blood flow to the coronary artery when the frame 222 is expanded and positioned so that the solid wall is at the entrance of the coronary artery 104.

[0153] Reference is now made to FIG. 2D, which is a simplified diagrammatic illustration of a device for preventing blood flow into a coronary artery, according to an exemplary embodiment.

[0154] FIG. 2D is intended to show a device that filters blood entering the coronary arteries and blocks debris from entering the coronary arteries 104.

[0155] 2D shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 are shown (ascending aorta 106A, aortic arch 106B, and descending aorta 106C).

[0156] FIG. 2D shows a device 232 for filtering blood entering the coronary artery 104 .

[0157] FIG. 2D shows a device 232 (e.g., an expandable frame 232 shaped and sized to expand against the wall of the ascending aorta at the exit of the coronary artery), the frame including a mesh filter at least at the entrance of the coronary artery 104, which can filter blood flow into the coronary artery when the frame 232 is expanded and positioned so that the filter is at the entrance of the coronary artery 104.

[0158] Reference is made to FIG. 2E, which is a simplified diagrammatic view of a device for preventing blood flow into a coronary artery, according to an exemplary embodiment.

[0159] FIG. 2E is intended to show an expandable device blocking blood flow into a coronary artery.

[0160] 2E shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 (ascending aorta 106A, aortic arch 106B, and descending aorta 106C) are shown.

[0161] FIG. 2E shows a device 242 that prevents blood from entering the coronary artery 104 .

[0162] FIG. 2E shows a device 242 (e.g., an inflatable balloon or tube 242 shaped and sized to expand against the wall of the ascending aorta at its exit to the coronary artery), such that the inflatable balloon or tube 242 blocks the entrance to the coronary artery 104 and blocks blood flow to the coronary artery when the inflatable balloon or tube 242 is inflated.

[0163] In some embodiments, the inflatable balloon or tube 242 includes a hollow central portion 244 that allows blood to flow through.

[0164] In some embodiments, the inflatable balloon or tube 242 includes a hollow central portion 244 that allows for the passage of a medical instrument.

[0165] Reference is now made to FIG. 2F, which is a simplified diagrammatic illustration of a device for preventing backflow of debris according to an exemplary embodiment.

[0166] In some embodiments, FIG. 2F is intended to show a device that functions as a one-way flow valve.

[0167] In some embodiments, Figure 2F is intended to show a device that functions as a filter.

[0168] FIG. 2F shows the aorta 102, the direction 256 of blood flow from the heart into the aorta 102, a device including valve leaflets 252A, 252B to prevent backflow of blood, and control wires 254 for opening (252B) and closing (252A) the valve leaflets.

[0169] FIG. 2F shows a valve leaflet in an open, non-debris blocking state 252A next to a closed, debris blocking state 252B.

[0170] In some embodiments, the leaflets 252A, 252B are flexible, allowing a medical device (not shown) to pass along the leaflets 252A, 252B, but when the leaflets 252B are enabled to block backflow, the leaflets 252B can fit tightly against the medical device, blocking the space between the leaflets 252B and the medical device and blocking the backflow of blood.

[0171] In some embodiments, the leaflets 252A, 252B are non-porous and block the backflow of blood along the aorta.

[0172] In some embodiments, the leaflets 252A, 252B are porous and configured as a mesh that blocks the backflow of debris along the aorta but allows the backflow of blood, hi some embodiments, the pore size of the mesh is selected in the range of 120 to 30 microns.

[0173] In some embodiments, the leaflets 252A, 252B are opened and / or closed by external handles that act on control wires.

[0174] In some embodiments, particularly those that block backflow of blood along the aorta into the coronary arteries, the leaflets are closed for a short period of time, for example, in the range of 20 to 40 seconds (252B).

[0175] It should be noted that the device for blocking the inflow of debris into the coronary arteries and / or the device for blocking the backflow of blood into the coronary arteries are designed to work in conjunction with additional debris protection devices.

[0176] Reference is now made to FIG. 3A, which is a simplified diagrammatic illustration of a coronary protection device positioned in an aorta in conjunction with a debris protection device for preventing debris from entering a cerebral artery, according to an exemplary embodiment.

[0177] FIG. 3A is intended to illustrate how the coronary protection devices described herein may be positioned and operated in conjunction with an aortic protection device for protecting cerebral arteries (such as, by way of non-limiting example, an aortic protection device such as that described in International Patent Application Publication No. WO 2019 / 064223 to Brandeis, supra).

[0178] 3A shows the aorta 102 and the arteries that branch off from it: the coronary arteries 104, the brachiocephalic artery 108, the left common carotid artery 110, and the left subclavian artery 112. Portions of the aorta 102 are shown: the ascending aorta 106A, the aortic arch 106B, and the descending aorta 106C.

[0179] FIG. 3A shows a coronary protection device 302 for preventing blood flow into the coronary arteries 104 and an aortic protection device 306 positioned in different portions of the aorta 102.

[0180] In some embodiments, the coronary protection device 302 can be a device that blocks the flow of blood into the coronary artery 104, as shown in Figures 2C and 2E.

[0181] In some embodiments, the coronary protection device 302 can be a device that filters blood entering the coronary artery 104, as shown in FIG. 2D.

[0182] In some embodiments, the coronary protection device 302 can be a one-way device that blocks blood from flowing backward into the coronary artery 104, as shown in FIG. 2A.

[0183] In some embodiments, the coronary protection device 302 can be a one-way device that filters backflow blood that may enter the coronary artery 104, as shown in FIG. 2B.

[0184] Reference is now made to FIG. 3B, which is a simplified diagrammatic illustration of a coronary protection device positioned in the aorta in conjunction with a debris capture device, according to an exemplary embodiment.

[0185] FIG. 3B is intended to illustrate how the coronary artery protection devices described herein may be positioned and operated in conjunction with, by way of non-limiting example, a debris trapping device, such as those described in U.S. Provisional Patent Application No. 63 / 398,546 to Brandeis, supra.

[0186] 3B shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 are shown (ascending aorta 106A, aortic arch 106B, and descending aorta 106C).

[0187] FIG. 3B illustrates a coronary artery protection device 302, e.g., as described herein with reference to any of FIGS. 2A-2E, and a debris capture device 312, e.g., as described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546.

[0188] Reference is now made to FIG. 3C, which is a simplified diagrammatic illustration of a coronary protection device positioned in the aorta in conjunction with a debris capture device and an aortic protection device according to an exemplary embodiment.

[0189] FIG. 3C is intended to illustrate how the coronary artery protection devices described herein may be positioned and operated in conjunction with, by way of non-limiting example, a debris capture device (such as those described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546) and an aortic protection device for protecting cerebral arteries (such as those described in the above-referenced International Patent Application Publication No. WO 2019 / 064223 to Brandeis).

[0190] 3C shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 are shown (ascending aorta 106A, aortic arch 106B, and descending aorta 106C).

[0191] FIG. 3C illustrates a coronary artery protection device 302, e.g., as described herein with reference to any of FIGS. 2A-2E, a debris capture device 312, e.g., as described in U.S. Provisional Patent Application No. 63 / 398,546, supra, and an aortic protection device 306 for protecting cerebral arteries, e.g., as described in Brandeis International Patent Application Publication No. WO 2019 / 064223, supra.

[0192] Reference is now made to FIG. 3D, which is a simplified diagrammatic illustration of a coronary protection device positioned in the aorta in conjunction with a debris capture device and an aortic protection device according to an exemplary embodiment.

[0193] FIG. 3D is intended to illustrate how the coronary artery protection devices described herein may be positioned and operated in conjunction with, by way of non-limiting example, a debris capture device (such as those described in U.S. Provisional Patent Application No. 63 / 398,546, supra) and an aortic protection device for protecting cerebral arteries (such as those described in Brandeis' International Patent Application Publication No. WO 2019 / 064223, supra).

[0194] 3D shows the aorta 102 and the arteries that branch off from it (coronary arteries 104, brachiocephalic artery 108, left common carotid artery 110, and left subclavian artery 112). Portions of the aorta 102 are shown (ascending aorta 106A, aortic arch 106B, and descending aorta 106C).

[0195] FIG. 3D shows a coronary artery protection device 302, e.g., as described herein with reference to any of FIGS. 2A-2E, a debris capture device 312, e.g., as described in the above-mentioned U.S. Provisional Patent Application No. 63 / 398,546, and an aortic protection device 306 for protecting cerebral arteries, such as those described in the above-mentioned International Patent Application Publication No. WO 2019 / 064223 to Brandeis, wherein the debris capture device 312 is disposed within a lumen formed by the aortic protection device 306.

[0196] Reference is now made to FIG. 4A, which is a simplified flowchart illustration of a method for reducing damage to the heart during a vascular procedure, according to an exemplary embodiment.

[0197] The method of FIG. Identifying events that may generate debris (402); In response to identifying, reducing debris carried by backflow from the aorta to the coronary arteries during diastole (404); Includes.

[0198] Reference is now made to FIG. 4B, which is a simplified flowchart illustration of a method for protecting coronary arteries from debris intrusion during a medical procedure, according to an exemplary embodiment.

[0199] The method of FIG. 4B inserting a device into the patient's aorta to protect the coronary artery from debris intrusion (412); positioning the device to protect the coronary artery from debris intrusion (414); performing a medical procedure on a patient's heart (416); Includes.

[0200] Reference is now made to FIG. 5A, which is a simplified flowchart illustration of a method for preventing backflow of blood into a coronary artery during a medical procedure, according to an exemplary embodiment.

[0201] The method of FIG. deploying (502) a one-way valve in the patient's aorta to prevent backflow of blood into the coronary arteries; Inserting a TAVI delivery system into the aorta (504); activating the one-way valve to prevent backflow of blood into the coronary artery (506); activating the prosthesis (508); and retrieving the TAVI delivery system from the patient's body (510); retrieving the one-way valve from the patient's body (512); Includes.

[0202] Note that after activating the one-way valve (506), there is no backflow of blood into the coronary artery (514).

[0203] Note that there is no backflow of blood into the coronary arteries (516) while the prosthesis is being activated (508).

[0204] In some embodiments, activating the prosthesis (508) is optionally accomplished by expanding a balloon, as known in the art, with the balloon expansion occurring under protection and without backflow of blood into the coronary artery (516).

[0205] In some embodiments, after activating the one-way valve (506), the physician may need to reposition the prosthesis before activating the prosthesis (508), optionally with protection and no backflow of blood into the coronary arteries (516).

[0206] When the prosthesis is deployed, some types of devices require the implant to be secured in place, which is done by expanding a balloon. In some cases of blood leaking from the side of the implant, expanding the balloon is used to secure the prosthesis / implant to the heart and stop the leak.

[0207] During TAVI, the physician may need to correct the position of the prosthesis / implant. For example, the angle of the prosthesis may need adjustment, or the prosthesis may be too deep in the heart, or not deep enough, or may be covering the ostium of a coronary artery. In some embodiments, the balloon can be deflated, moving the implant back and forth, or the "landing" angle can be changed.

[0208] Reference is now made to FIG. 5B, which is a simplified flowchart illustration of a method for protecting coronary arteries from particle intrusion during a medical procedure, according to an exemplary embodiment.

[0209] The method of FIG. 5B Inserting a TAVI delivery catheter having an additional coronary artery filter into the patient's aorta (522); Positioning an aortic valve replacement and positioning a coronary filter in position relative to the coronary artery ostium (524); Deploying aortic valve replacements (526) and Optionally, repositioning and / or balloon dilating the aortic valve prosthesis (528); Retrieving the TAVI delivery system and coronary artery filter (530); Includes:

[0210] Note that coronary particle protection begins with positioning 524 (532).

[0211] Note that particle protection of the coronary arteries continues (534) during deployment (526).

[0212] Note that if optional repositioning and / or balloon dilation is performed (528), particle protection of the coronary arteries continues (536).

[0213] Table 1 below shows examples of TAVI procedures in an exemplary embodiment and how the TAVI procedures relate to the risk of debris showering and the status of the coronary protection device.

[0214] [Table 1]

[0215] Reference is made to FIG. 6A, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0216] FIG. 6A is intended to show a device for protecting a coronary artery that includes a filter that filters blood at the entrance to the coronary artery.

[0217] Figure 6A shows a TAVI delivery system 606 inserted into the aorta 602 with a heart valve prosthesis 608 in place. Figure 6A also shows a filter device 604 deployed to protect a coronary artery 607.

[0218] In some embodiments, the filter device 604 can optionally slide along the same TAVI delivery system 606 as the heart valve prosthesis 608 .

[0219] Reference is now made to FIG. 6B, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0220] FIG. 6B is intended to show a device for protecting a coronary artery that includes a one-way valve.

[0221] Figure 6B shows a TAVI delivery system 616 inserted into the aorta 612 with a heart valve prosthesis 618 in place. Figure 6B also shows a one-way valve device 614 deployed to protect a coronary artery 617.

[0222] In some embodiments, the one-way valve device 614 can optionally slide along the same TAVI delivery system 616 as the heart valve prosthesis 618 .

[0223] FIG. 6B also shows an optional control wire 619 for controlling activation of the one-way valve device 614 .

[0224] Reference is now made to FIG. 6C, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0225] FIG. 6C is intended to show a device for protecting the coronary arteries, including a one-way valve and a filter for protecting the entrance of the coronary arteries.

[0226] Figure 6C shows a TAVI delivery system 626 inserted into the aorta 622 and a heart valve prosthesis 628 in place. Figure 6C also shows a one-way valve device 624 positioned to protect a coronary artery 627, and a filter 625 to protect the entrance to the coronary artery 627.

[0227] In some embodiments, the one-way valve device 624 can optionally slide along the same TAVI delivery system 626 as the heart valve prosthesis 628 .

[0228] In some embodiments, optionally, a filter 625 for protecting the entrance to the coronary artery 627 can slide along the same TAVI delivery system 626 as the heart valve prosthesis 628 .

[0229] Reference is now made to FIG. 6D, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0230] FIG. 6D is intended to show a coronary artery protection device that includes a dual filter for protecting the coronary artery entrance.

[0231] Figure 6D shows a TAVI delivery system 636 inserted into the aorta 632. Figure 6D also shows a filter for protecting the entrance to a coronary artery 637, which includes a first outer mesh layer 634A and a second inner mesh layer 634B.

[0232] In some embodiments, the first outer mesh layer 634A and the second inner mesh layer 634B can optionally have mesh with different pore sizes.

[0233] In some embodiments, the first outer mesh layer 634A and the second inner mesh layer 634B can optionally each be independently enabled, i.e., one layer can be enabled as a filter while the other layer is not.

[0234] In some embodiments, both the first outer mesh layer 634A and the second inner mesh layer 634B can optionally be enabled together, i.e., both layers can be enabled as filters or disabled as filters.

[0235] In some embodiments, the filter device can optionally slide along the same TAVI delivery system 636 as the heart valve prosthesis (not shown).

[0236] Reference is now made to FIG. 6E, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0237] FIG. 6E is intended to show a device for protecting the coronary arteries, including one or more filters for protecting the coronary ostia, ie, the entrance to the coronary arteries.

[0238] FIG. 6E shows a device 642 inserted into the aorta 102 to protect the entrance 644 of the coronary artery 104 .

[0239] The device 642 is sized and shaped to cover an entrance 644 to the coronary artery 104 .

[0240] The device 642 includes one or more filters 646 and 648 positioned within the device 642 to correspond to the location of an entrance 644 to the coronary artery 104 .

[0241] In some embodiments, by way of non-limiting example, when protecting a coronary artery in connection with a TAVI procedure, device 642 optionally slides along the outside of tubing 649 used in the TAVI procedure. In some embodiments, TAVI tubing 649 is optionally guided up to the aortic valve, after which device 642 is slid along the outside of tubing 649, and the device is optionally positioned such that filters 646, 648 cover the entrance 644 of coronary artery 104.

[0242] Reference is now made to FIG. 6F, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0243] FIG. 6F is intended to show one or more devices for protecting the coronary arteries, including a filter for protecting the coronary ostium, i.e., the entrance to the coronary artery, and control wires for positioning the device at the coronary ostium.

[0244] FIG. 6F shows, by way of non-limiting example, the insertion of two devices into the aorta 102 to protect the entrance 644 of the coronary artery 104.

[0245] Each device includes a mesh 652, 654 sized and shaped to cover the entrance 644 of the coronary artery 104, and control and / or guide wires 656, 658 for directing the mesh 652, 654 into the coronary artery ostium.

[0246] In some embodiments, by way of non-limiting example, when protecting the coronary arteries in connection with a TAVI procedure, the mesh 652, 654 optionally slides along the outside of the tubing (not shown, see FIG. 6E) used in the TAVI procedure. In some embodiments, the TAVI tubing is optionally guided to the aortic valve, after which the mesh 652, 654 is optionally slid along the outside of the tubing, and the mesh 652, 654 is optionally positioned such that the filter mesh 652, 654 covers the entrance 644 of the coronary artery 104.

[0247] In some medical procedures involving the aortic valve, the leaflets of the aortic valve may be pushed to cover the ostia of one or more coronary arteries. Coverage of the ostia may be undesirable, especially if it continues for a period of time that could result in damage to the heart due to a lack of blood flow to the heart's vessels.

[0248] The coronary artery protection devices described herein may push the aortic valve leaflets away from the entrance to the coronary arteries.

[0249] In some embodiments, the tools for protecting coronary arteries described herein may be used to push the leaflets of the aortic valve away from the entrance of the coronary arteries.

[0250] In some embodiments, filters such as filters 646 and 648 shown in FIG. 6E and filters 652 and 654 shown in FIG. 6F are designed to form a cage that optionally protrudes from the wall of the aorta, holding the aortic valve leaflets away from the wall of the aorta and, optionally, preventing them from blocking the ostia of the coronary arteries.

[0251] In some embodiments, filters such as filters 646 and 648 shown in FIG. 6E and filters 652 and 654 shown in FIG. 6F are designed to include portions that optionally protrude into the coronary artery ostium, the distance ranging from 0.5 to up to 20 millimeters.

[0252] Projecting into the coronary ostium may help maintain the position of the filter at the entrance to the coronary artery.

[0253] Reference is now made to FIG. 6G, which is a simplified diagrammatic illustration of a device for protecting coronary arteries according to an exemplary embodiment.

[0254] FIG. 6G is intended to show the components and methods for compressing the walls of the coronary artery protection device against the arterial wall.

[0255] 6G shows a device 664 protecting a coronary artery 663 placed at the entrance of the coronary artery 663. FIG. 6G also shows the heart 660, an artery 661 leading to the brain, and the descending aorta 662.

[0256] In some embodiments, as shown on the left side of FIG. 6G, a balloon 667 is inserted into the device 664 and is used to inflate the balloon to compress the walls of the device 664 against the wall 668 of the artery.

[0257] In some embodiments, the device 664 optionally includes a control wire 665 .

[0258] In some embodiments, the balloon 667 optionally includes control wires 669 and / or tubes 669 for inflating and / or deflating the balloon 667 .

[0259] It is expected that many related medical procedures will be developed during the life of the patent that matures from this application, and the scope of the term medical procedure is intended to pre-emptively include all such new technologies.

[0260] The terms "comprising," "including," "having," and conjugations thereof mean "including but not limited to."

[0261] The term "consisting of" means "including and limited to."

[0262] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0263] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, "a unit" or "at least one unit" includes plural units and can also include combinations thereof.

[0264] The words "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." An embodiment described as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or does not necessarily exclude features of other embodiments from being incorporated.

[0265] "Optionally" is used herein to mean "provided in some embodiments and not provided in other embodiments." Any particular embodiment of the present disclosure may include multiple "optional" features unless those "optional" features contradict each other.

[0266] Throughout this application, various embodiments of the present 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 is not an inflexible limitation on the scope of the present disclosure. Thus, the description of a range should be considered to specifically disclose all of the possible subranges and individual numerical values ​​within that range. For example, description of a range such as 1 to 6 specifically discloses subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the magnitude of the range.

[0267] When a range of values ​​is provided herein (e.g., any pair of numbers connected by "10-15," "10 to 15," or other range designations), it is intended to include any number (fractional or integer) within the limits of the range provided, unless the context clearly dictates otherwise. The phrases "range between" a first designated number and a second designated number, and "range," "range to," "range to," or "range including" (or other similar range terminology) "from" a first designated number to a second designated number, are used interchangeably herein and are meant to include the first and second designated numbers and all fractional and integer values ​​therebetween.

[0268] Unless otherwise indicated, numbers used herein, and any numerical ranges based thereon, are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0269] As used herein, the term "method" means manner, means, techniques, and procedures for accomplishing a given task, including, but not limited to, those known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine, or those that can be readily developed by practitioners from known manners, means, techniques, and procedures.

[0270] As used herein, the term "treating" includes arresting, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the worsening of the clinical or cosmetic symptoms of a condition.

[0271] It should be understood that certain features of the present disclosure, which are for clarity described in the context of separate embodiments, may also be provided in any combination of these features in a single embodiment. Conversely, multiple features of the present disclosure, which are for brevity described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or with respect to other described embodiments as appropriate. A given feature described in the context of various embodiments should not be construed as essential to that embodiment, unless the particular embodiment is inoperable without that element.

[0272] While this disclosure has been described in conjunction with specific embodiments thereof, 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.

[0273] It is the intention of the applicants that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, and patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Nor should it necessarily be construed as limiting, to the extent that section headings are used. In addition, the priority document of this application, if any, is incorporated herein by reference in its entirety.

Claims

1. A device that protects the coronary arteries from debris intrusion, Expandable frame, A debris shielding barrier is provided, The aforementioned expandable frame is positioned against the wall of the ascending aorta, The aforementioned outlet to the coronary artery, The area immediately downstream of the outlet to the coronary artery, The shape and size are set to expand at a position selected from the group consisting of the following: The debris barrier includes a unidirectional barrier whose shape and size are configured to prevent particles from being pushed upstream toward the coronary arteries of the heart during diastole. device.

2. The debris blocking barrier includes a solid portion of the expandable frame at the entrance to the coronary artery, thereby enabling the expansion of the expandable frame to block blood flow to the coronary artery when it is expanded. The device according to claim 1.

3. The debris barrier includes an inflatable balloon having a hollow, tubular shape, the inflatable balloon being shaped and sized such that when inflated it presses against the wall of the aorta and blocks blood flow to the coronary arteries. The device according to claim 1.

4. The inflatable balloon includes a flexible projection that is shaped and sized to maintain a flow path for blood around the inflatable balloon when the balloon is not inflated. The device according to claim 3.

5. The debris barrier includes a mesh having holes sized to prevent the passage of particles larger than 30 microns ± 10 microns, and the mesh is attached to the expandable frame. When the expandable frame expands against the wall of the ascending aorta at the outlet to the coronary artery, the mesh filters the blood entering the coronary artery. The device according to claim 1.

6. The mesh is designed so that the size of the holes in the mesh can be controlled to change. The device according to claim 5.

7. The aforementioned mesh is designed to change the pore size from a range of 120 to 150 microns to a range of 30 to 50 microns. The device according to claim 5.

8. The aforementioned mesh is designed to be completely closed. The device according to claim 5.

9. The aforementioned one-way barrier is a. One-way valve, b. A flap that allows downstream flow and blocks upstream flow. c. Mesh to prevent debris from flowing upstream. d. Control wires for controlling the activation and deactivation of the unidirectional barrier, e. A flap that, when blood attempts to flow upstream during diastole, is pushed by the blood and extends across the ascending aorta, thereby blocking the backflow of the blood. f. A mesh flap that, when blood attempts to flow upstream during diastole, is pushed by the blood and extends across the ascending aorta, thereby blocking the backflow of debris while allowing the backflow of at least a portion of the blood. g. Both an impermeable flap and a mesh flap extending across the ascending aorta, pushed by the blood when blood attempts to flow upstream during diastole, the impermeable flap obstructing the backflow of blood, the mesh flap allowing at least some backflow of blood, and the impermeable flap and the mesh flap being individually controllable. Including one or more of the following: The device according to claim 1.

10. The debris barrier is designed to be activatable to change from a state in which it prevents particles from being pushed upstream during expansion to a state in which it does not prevent particles from being pushed upstream during contraction. The device according to claim 9.

11. The debris shielding barrier includes a radiopaque marker for detecting whether the debris shielding barrier is enabled to block debris. The device according to claim 9.

12. The device includes a combination of multiple types of debris shielding barriers. The device according to claim 1.

13. The device is configured to be integrated with a TAVI / TAVR delivery system. The device according to claim 1.

14. The device is configured to slide along the TAVI / TAVR guidewire. The device according to claim 1.

15. The device is configured to be integrated with cerebral embolism protection (CEP) or embolic protection device (EPD). The device according to claim 1.

16. The expandable frame includes a shape memory alloy, The device according to claim 1.

17. The aforementioned expandable frame includes a polymer, The device according to claim 1.

18. The device is configured such that, when placed in the aorta, a medical instrument can pass along the device upstream of the device. The device according to claim 1.

19. The aforementioned device is configured to enter the patient's body along with medical instruments used for performing surgery on the heart. The device according to claim 1.

20. The expandable frame is configured such that the device is locked to the wall of the ascending aorta by the expansion of the expandable frame, thereby resisting movement along the direction of blood flow. The device according to claim 9.

Images