Managing debris protection associated with vascular or cardiac medical procedures

Abstract

A method of managing debris protection associated with a medical procedure, the method comprising: activating a debris protection device disposed in a body lumen to prevent debris from flowing along with bodily fluids into a body organ before commencing a step of the medical procedure that may generate debris; and deactivating the debris protection device before the activated debris protection device may cause damage to the body organ. An activation mechanism for activating a debris protection device associated with a medical procedure, the mechanism including a spring that requires the application of force to activate the device. An activation mechanism for activating a debris protection device associated with a medical procedure, the mechanism being programmed to automatically activate the device based on an activation input. Related apparatus and methods are also described.

Description

[Technical Field]

[0001] Related Applications This application is a PCT application claiming benefit of priority to U.S. Provisional Patent Application No. 63 / 400,773, entitled "Managing Debris Protection Associated with Vascular or Cardiac Medical Procedures," filed August 25, 2022; U.S. Provisional Patent Application No. 63 / 400,771, entitled "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures," filed August 25, 2022; and U.S. Provisional Patent Application No. 63 / 400,779, entitled "Anchoring a Debris Protection Device Within a Body Lumen," filed August 25, 2023; and related to U.S. Provisional Patent Application No. 63 / 398,546, entitled "Trapping Flowing Debris in Blood Vessels and Other Body Lumens," filed August 17, 2022.

[0002] The contents of all of the above applications are incorporated herein by reference as if fully set forth herein. [Background technology]

[0003] The present disclosure, in some embodiments thereof, relates to methods and devices relating to the management of debris protection in connection with vascular or cardiac medical procedures, and in particular to the management of debris protection in connection with procedure-related medical operations that are expected to generate blood-borne debris, which may injure and / or damage and / or obstruct blood vessels in the brain and / or heart and / or other body organs.

[0004] The background art is as follows: International Patent Application Publication No. 2019 / 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.

[0005] 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

[0006] The present disclosure, in some embodiments thereof, relates to methods and devices relating to the management of debris protection associated with vascular or cardiac medical procedures, and particularly, but not exclusively, to the management of debris protection associated with medical procedures expected to generate blood-borne debris.

[0007] According to an aspect of some embodiments of the present disclosure, there is provided a method of managing debris protection associated with a medical procedure, the method comprising: activating a debris protection device disposed in a body lumen to prevent debris from flowing along with bodily fluids into a body organ before commencing a step of the medical procedure that may generate debris; and deactivating the debris protection device before the activated debris protection device may cause damage to the body organ.

[0008] According to some embodiments of the present disclosure, the enabling includes enabling a debris capture device positioned in the aorta.

[0009] According to some embodiments of the present disclosure, the enabling includes enabling filtering of blood entering a coronary artery.

[0010] According to some embodiments of the present disclosure, the enabling includes blocking blood from entering a coronary artery.

[0011] According to some embodiments of the present disclosure, the enabling occurs prior to performing a pace-up step in a valve replacement medical procedure.

[0012] According to some embodiments of the present disclosure, the enabling occurs simultaneously with performing a pace-up step in a valve replacement medical procedure.

[0013] According to some embodiments of the present disclosure, enabling includes enabling filtering of blood through a mesh having a mesh pore size ranging from 120 microns to 500 microns.

[0014] According to some embodiments of the present disclosure, the enabling includes enabling prior to positioning the implantable device at a location in the heart.

[0015] According to some embodiments of the present disclosure, enabling includes enabling filtering of blood through a mesh having a mesh pore size in the range of 30 microns to 120 microns.

[0016] According to some embodiments of the present disclosure, enabling includes enabling filtering of blood through a mesh having a mesh pore size ranging from 0 microns to 6 microns.

[0017] According to some embodiments of the present disclosure, the enabling includes enabling the implantable device in position in the heart prior to expanding it.

[0018] According to some embodiments of the present disclosure, the enabling occurs prior to performing a pace-down step in a valve replacement medical procedure.

[0019] According to some embodiments of the present disclosure, the deactivation occurs after a duration ranging from 5 seconds to 60 seconds.

[0020] According to some embodiments of the present disclosure, the deactivation occurs after a duration ranging from 5 seconds to 120 seconds.

[0021] According to some embodiments of the present disclosure, the disabling is performed automatically by a timer.

[0022] According to some embodiments of the present disclosure, the disabling is performed automatically based on a signal from a sensor.

[0023] According to some embodiments of the present disclosure, the enabling is performed automatically based on a signal from a sensor.

[0024] According to some embodiments of the present disclosure, the enabling includes enabling a debris capture device positioned in the vena cava.

[0025] According to some embodiments of the present disclosure, the enabling includes enabling a debris filtering device positioned in the vena cava.

[0026] According to some embodiments of the present disclosure, the enabling requires the application of a force.

[0027] According to an aspect of some embodiments of the present disclosure, there is provided an activation mechanism for activating a debris protection device in connection with a medical procedure, the activation mechanism including a spring that requires the application of force to activate the debris protection device.

[0028] According to some embodiments of the present disclosure, further includes automatic override based on override input.

[0029] According to some embodiments of the present disclosure, the deactivation input comprises an input from a timer set for a particular duration of activation of the debris protection device.

[0030] According to some embodiments of the present disclosure, the override input includes an input from a pulse sensor.

[0031] According to some embodiments of the present disclosure, the overriding input includes an input from a blood oxygen sensor.

[0032] According to an aspect of some embodiments of the present disclosure, there is provided an activation mechanism for activating a debris protection device in connection with a medical procedure, the activation mechanism being programmed to automatically activate the debris protection device based on an activation input.

[0033] According to an aspect of some embodiments of the present disclosure, there is provided a user interface for managing a debris protection device, said user interface including displays selected from the group of an enable indicator, a disable indicator, a timer, a patient pulse indicator, a fluid debris indicator, a blood oxygen indicator, an intracranial Doppler based particle indicator, a B-wave Doppler based particle indicator, a spectral Doppler based particle indicator, an optofluid sensor based particle indicator, and an impedance sensor based particle indicator.

[0034] 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.

[0035] 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]

[0036] [Figure 1A] FIG. 1 is a simplified diagrammatic view of a debris protection device as described in International Patent Application Publication No. WO2019 / 064223 to Brandeis, supra. [Figure 1B] 1 is a simplified diagrammatic view of a debris protection device as described in the above-referenced U.S. provisional patent application (Docket No. 91186) entitled "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures." [Figure 1C] 1 is a simplified diagrammatic view of a debris protection device as described in the above-referenced U.S. provisional patent application (Docket No. 91186) entitled "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures." [Figure 1D] 1 is a simplified diagram of a debris capture device as described in the aforementioned US Provisional Patent Application No. 63 / 398,546, positioned in an aorta according to an exemplary embodiment. [Figure 1E] FIG. 1 is a simplified diagram of possible locations of a debris trapping device, such as that described in the aforementioned U.S. Provisional Patent Application No. 63 / 398,546, positioned in a vein according to some exemplary embodiments. [Figure 2] FIG. 1 is a simplified flow chart diagram of a method for performing a medical procedure protected by one or more debris protection devices according to an exemplary embodiment. [Figure 3] FIG. 1 is a simplified block diagram of a method for performing a medical procedure protected by one or more debris protection devices according to an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0037] In some embodiments thereof, the present disclosure relates to methods and devices for managing debris protection in connection with vascular or cardiac medical procedures, and in particular to managing debris protection in connection with medical procedures that are expected to generate blood-borne debris.

[0038] overview introduction Various medical procedures are expected to generate debris that can be carried by bodily fluids to various body organs, causing potential debris damage. Patients undergoing such procedures may benefit from the medical procedure but may subsequently be injured by the debris.

[0039] Non-limiting examples of medical procedures that are expected to generate blood-borne debris include cardiac procedures such as electrophysiology procedures, patent foramen ovale (PFO) procedures, heart valve repair, open-heart surgery, percutaneous aortic valve replacement (PAVR), percutaneous aortic valve implantation (PAVI), transcatheter aortic valve implantation (TAVI), and transcatheter aortic valve replacement (TAVR). Such medical procedures are expected to generate debris that can travel downstream from the heart and reach the coronary arteries, brain, kidneys, etc.

[0040] Additional non-limiting examples of medical procedures that are expected to generate bloodborne debris include medical procedures on the body that cause debris to be released into the veins, which then flow into the right side of the heart and into the lungs, where it can have serious pulmonary effects.

[0041] Debris can include organized and disorganized thrombus, calcifications, tissue fragments of various origins, non-biological particles such as polymers and other materials, and gas particles such as gas bubbles.

[0042] Gas particles and other types of debris can be introduced into the vascular system via medical procedures, medical devices, and medical equipment, including heart-lung devices, extracorporeal membrane oxygenation (ECMO) machines, extracorporeal life support (ECLS) machines, cardiac and vascular assist devices, and blood filtering devices.

[0043] Debris can include large particles between 120 microns and 500 microns, even larger particles between 500 microns and 1000 microns or more, and small particles (also called microemboli) in the size range of 30 microns to 60 microns or less.

[0044] Management of debris entrapment aims to prevent occlusion of arteries branching from the aorta, which could result in injury to the celiac trunk, superior mesenteric artery, renal arteries, gonadal arteries, and inferior mesenteric arteries.

[0045] In some embodiments, debris capture and / or filtering may optionally be set to a small pore size to prevent further damage to organs such as the intestines, pelvic organs, kidneys, liver, etc., by way of non-limiting example in patients with known disease, deformity, or dysfunction.

[0046] In some embodiments, for the patient conditions described above, the duration of debris capture may be altered to avoid worsening the known condition, for example, the duration may be increased to provide more protection or decreased to prevent blood shortages.

[0047] Non-limiting examples of debris protection devices Non-limiting examples of debris protection include devices that filter blood entering blood vessels leading to debris-sensitive organs, devices that trap debris flowing along blood vessels, and devices that block blood entering blood vessels leading to debris-sensitive organs.

[0048] In some embodiments, the filtering device includes filtering through a large pore size mesh (e.g., in the range of 120 microns to 500 microns), or filtering through a small pore size mesh (e.g., in the range of 30 microns to 120 microns), or filtering through the smallest pore size mesh (e.g., in the range of 6 microns to 30 microns), or even completely blocking blood flow using a filter with a pore size of 0 microns to 6 microns.

[0049] In some embodiments, the filtering device is optionally controllable to be enabled from no filtering, or filtering with a large pore size, to filtering with a small or minimal pore size.

[0050] Non-limiting examples for debris protection include devices that trap debris flowing along blood vessels.

[0051] In some embodiments, the filtering device is optionally controllable to be enabled from not trapping debris or trapping with a large pore size trap to filtering with a small or minimal pore size.

[0052] Non-limiting examples for debris protection include devices that block blood from entering blood vessels leading to organs that are susceptible to debris.

[0053] In some embodiments, the blocking device may be placed at the entrance to a blood vessel leading to an organ that is susceptible to debris.

[0054] In some embodiments, the blocking device may be a one-way barrier or one-way valve that may prevent the backflow of blood containing debris. As a non-limiting example, a one-way valve activated in the aorta may prevent blood-borne debris from flowing back into the coronary arteries during diastole.

[0055] In some embodiments, the blocking device is optionally controllable to be enabled from a non-blocking state to a blocking state and disabled from a blocking state to a non-blocking state.

[0056] In some embodiments, a combination of filtering and blocking is optionally used. By way of non-limiting example, a one-way valve may include a mesh flap that, when activated, filters backflowing blood rather than completely blocking it.

[0057] Non-limiting examples of devices for debris protection are shown in Figures 1A through 1E.

[0058] Activation duration An aspect of some embodiments relates to managing the activation duration of a device that manages debris protection.

[0059] In some embodiments, managing can be blocking blood entering a coronary artery.

[0060] By way of non-limiting example, blocking blood flow to the coronary arteries can optionally be done for a short period of time, such as 5, 10, 20, 30, or up to 60 seconds, and the heart will not be deprived of blood for longer than this period.

[0061] As a non-limiting example, blocking blood flow into the coronary arteries optionally equals the duration of the Rapid Ventricular Pacing (RVP) step (also called the "pace-up" step) in a TAVI procedure, causing the patient's pulse rate to increase to the point of tachycardia, resulting in little or no blood supply to the heart and brain.

[0062] As a non-limiting example, blocking blood flow into the coronary arteries is optionally equal to the duration of a rapid ventricular pacing (RVP) step (also called a "pace-up" step) in a TAVI procedure, followed by a short period of time during which the heart effectively resumes pumping and a debris storm is expected. In some embodiments, an example period is equal to the duration of the pace-up plus a short additional period of time, for a total duration not to exceed 5, 10, 20, 30, or up to 60 seconds.

[0063] In some embodiments, managing can be done by filtering blood entering the artery.

[0064] In some embodiments, for meshes with relatively large pores (e.g., pores of about 120 microns), the duration may be longer than complete blocking, such as 1 minute, 2 minutes, 5 minutes, or more, or in some cases, there may be no time limit.

[0065] In some embodiments, for meshes with relatively small pores (e.g., pores ranging from about 30 microns to about 120 microns), the duration can be shorter than the filtering durations described above, longer than the blocking durations described above, or the same as the blocking durations described above. In a non-limiting example, the duration can optionally range from 20 seconds to 60 seconds.

[0066] In some embodiments, for meshes with relatively small pores (eg, pores less than 30 microns), the filtering may be even shorter than the above and may be the same as the blocking durations above.

[0067] In some embodiments, managing can be blocking blood, possibly containing debris, from entering the arteries of the brain.

[0068] The brain can typically tolerate a longer period without blood than the myocardium, and the duration of effectiveness of debris protection is typically longer than that indicated above for coronary debris protection.

[0069] In some embodiments, managing can be blocking blood, possibly containing debris, from entering the arteries to the kidneys. Note that the kidneys can tolerate ischemia for longer periods than the brain or heart.

[0070] When to activate An aspect of some embodiments relates to managing the timing of activation of devices that manage debris protection.

[0071] In some embodiments, the managing may be blocking blood entering a coronary or cerebral artery, in such embodiments the duration is expected to be relatively short as described above, and optionally the timing is related to the relevant medical procedure step for which debris protection is intended.

[0072] In some embodiments, the timing differs depending on whether the blockage is to a coronary artery or a cerebral artery.

[0073] In some embodiments, the managing is filtering the blood. In such embodiments, the duration may be longer as described above, and the timing may begin before or concurrently with the start of the debris-generating step of the medical procedure.

[0074] In some embodiments, the validation optionally occurs prior to the start of a medical procedure that is expected to generate debris.

[0075] In some embodiments, the validation optionally occurs before the start of a step in a medical procedure that is expected to generate debris.

[0076] In some embodiments, validation occurs before the pace-up of the TAVI procedure.

[0077] In some embodiments, the validation occurs simultaneously with the execution of a pace-up TAVI procedure.

[0078] In some embodiments, the validation occurs before the TAVI procedure is slowed down.

[0079] In some embodiments, the validation occurs simultaneously with the execution of a pace-down of the TAVI procedure.

[0080] Auto-enable An aspect of some embodiments relates to automatic activation of devices that manage debris protection.

[0081] In some embodiments, optionally, the activation of devices that manage debris protection is based on data from sensors.

[0082] In some embodiments, the sensors may optionally be, by way of non-limiting example, a pulse sensor, a debris detection sensor by image analysis, an activation detection sensor by detecting radiopaque markers attached to the device managing the debris protection, a blood oxygen sensor, B-wave ultrasound, intracranial Doppler, particle sensors in the heart, aorta, ascending aorta, cerebral arteries, descending aorta, inferior vena cava, superior vena cava, etc.

[0083] As a non-limiting example, a pulse sensor may indicate the timing of an up-pace step and the timing of a down-pace step.

[0084] As a non-limiting example, detection of debris through image analysis (e.g., analysis of X-ray images produced during a medical procedure) may indicate the presence of debris and that debris protection may be desirable.

[0085] In some embodiments, the sensor may optionally provide an audio and / or visual signal based on which the physician may optionally enable and / or disable the device managing debris protection.

[0086] In some embodiments, the sensor may optionally provide a signal that triggers automatic disabling of devices that manage debris protection based on the signal. Such a feature is a potential safety feature.

[0087] In some embodiments, the sensor may provide a signal that triggers automatic activation of a device that manages debris protection based on the signal.

[0088] safety features An aspect of some embodiments relates to patient safety in the operation of devices that manage debris protection.

[0089] In some embodiments, the debris protection device is a normally open device that does not normally block or filter fluid flow unless activated.

[0090] In some embodiments, the debris protection device is a normally open device that does not normally block fluid flow unless activated, but optionally filters the fluid flow using a pore size that does not damage organs downstream of the filtering.

[0091] In some embodiments, activation of the debris protection device is against resistance, for example where activation is optionally performed manually by a physician, a force must be applied to activate, in some embodiments the debris protection device is automatically deactivated when the application of force ceases.

[0092] In some embodiments, the debris protection device is automatically disabled by a timer.

[0093] In some embodiments, a timer is automatically started when the debris protection device is enabled, and the timer activates a warning signal after a desired duration of enablement has elapsed.

[0094] User Interface An aspect of some embodiments relates to a user interface for operation of a device for managing debris protection.

[0095] In some embodiments, the user interface optionally includes an indication of the status of the debris trapping device, optionally including whether it is enabled or not enabled, an indication of the pore size of a filter associated with the debris trapping device, an indication of the time since activation, a measurement of the amount of debris detected, and the patient's pulse rate.

[0096] 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.

[0097] Reference is made to FIG. 1A, which is a simplified diagrammatic view of a debris protection device as described in the above-referenced International Patent Application Publication No. WO 2019 / 064223 to Brandeis.

[0098] FIG. 1A shows an aortic protection device deployed in an aorta 102, the aortic protection device having a first mesh layer 104 and a compactly packed second mesh layer 108.

[0099] FIG. 1A also shows an expandable anchor stent 106 on the proximal side of the aortic protection device, a first control wire 112 attached to the distal end of the device, a second control wire 110 attached to the proximal end of the device and / or the expandable anchor stent 106, and a tube 114 through which the first control wire 112 and the second control wire 110 pass to the outside of the patient's body.

[0100] Reference is now made to FIG. 1B, which is a simplified diagrammatic representation of a debris protection device as described in the above-referenced US provisional patent application entitled "Protection of Coronary and Myocardial Vascular Systems During Medical Procedures" (Application Serial No. 91186).

[0101] FIG. 1B shows a simplified schematic block diagram of a coronary protection device 122 deployed in the aorta 102 , the coronary protection device being connected to a control wire 126 .

[0102] Reference is now made to FIG. 1C, which is a simplified diagrammatic representation of a debris protection device as described in the above-referenced US provisional patent application entitled "Protection of Coronary and Myocardial Vascular Systems During Medical Procedures" (Application Serial No. 91186).

[0103] FIG. 1C shows a simplified schematic block diagram of a coronary artery 124 protection device 132 deployed in the aorta 102, the coronary artery protection device 124 including a one-way valve 134, and the coronary artery protection device connected to a control wire 136.

[0104] Reference is made to FIG. 1D, which is a simplified illustration of a debris capture device such as that described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, positioned in the aorta according to an example embodiment.

[0105] 1D shows a debris trapping device 144 optionally having one or more levels of debris traps 146. The debris trapping device 144 is optionally placed in the descending aorta 142.

[0106] FIG. 1D shows a medical instrument 148, or a catheter 148, or a control wire 148 for the medical instrument, passing through the debris capture device 144, which is in an active state, i.e., the debris trap is open and the debris trapping leaves extend towards the middle of the descending aorta.

[0107] Figure ID shows a debris particle 147 trapped in the debris trap 146. Once the debris trap 146 is optionally closed, the trapped debris 147 can optionally be removed from the body along with the debris trapping device 144.

[0108] Reference is made to FIG. 1E, which shows a simplified diagram of potential locations for a debris trapping device such as that described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, which in some exemplary embodiments is placed in a vein.

[0109] 1E shows a vena cava 152 and a debris trapping device 154 placed in the vena cava 152. The vena cava 152 collects blood from the veins into the right atrium of the heart 158. The heart pumps the blood to the lungs. If debris reaches the lungs, it can be very harmful.

[0110] In some embodiments, a debris trapping device 154 is placed in the vena cava 152 to block such debris.

[0111] In some embodiments, the debris trapping device 154 traps the debris and is eventually removed from the body along with the debris.

[0112] In some embodiments, the debris trap of the debris trapping device 154 is closed to retain the trapped debris before removing it along with the debris from the body.

[0113] Reference is now made to FIG. 2, which illustrates in a simplified flow chart a method for performing a medical procedure protected by one or more debris protection devices according to an exemplary embodiment.

[0114] 2 is intended to illustrate steps of performing a TAVI procedure protected by one or more debris protection devices according to an exemplary embodiment. As non-limiting examples, the debris protection device may be a device such as that shown in FIGS. 1A-1D and / or may be a device described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, concurrently filed U.S. Provisional Patent Application "Protection of Coronary Arteries and Myocardial Vascular Vessels During Medical Procedures" (Application Serial No. 91186), U.S. Provisional Patent Application "Anchoring of a Debris Protection Device in a Body Lumen" (Application Serial No. 90786), and International Patent Application Publication No. WO 2019 / 064223 to Brandeis.

[0115] The method of FIG. 2 includes the following. Inserting one or more debris protection devices 202. Insertion can optionally be done via femoral access, which may be the same as the access for the TAVI procedure, or from a different access location, e.g., a different leg.

[0116] One or more debris protection devices are placed and / or deployed at designated locations (206), from which point, for example, cerebral arteries are protected (208).

[0117] Allowing passage of additional medical procedure instruments, such as TAVY instruments and / or prostheses (210). Allowing passage is accomplished by opening a passage along the debris protection device. At this point, for example, the cerebral artery is protected (212).

[0118] The TAVI prosthesis is deployed, and a debris protection device is optionally activated (214), optionally providing a higher level of debris protection, e.g., by reducing the pore size of the filtering mesh or activating a particle capture device. At this point, for example, the cerebral arteries are optionally protected with a higher degree of protection, optionally by a low-permeability filter and / or particle capture device (216).

[0119] The TAVI prosthesis is deployed (218), which may optionally require repositioning, at which point, for example, the cerebral artery is optionally further protected by a low-permeability filter and / or particle capture device (220).

[0120] The TAVI prosthesis is fixed in place (222). Fixation is achieved by balloon inflation. At this point, for example, the cerebral artery is optionally further protected by a low-permeability filter and / or particle capture device (220).

[0121] The TAVI device is then withdrawn. (226) At this point, at least the cerebral arteries are protected. (228)

[0122] Retrieving the debris protection device (230).

[0123] Reference is now made to FIG. 3, which illustrates in a simplified block diagram a method for performing a medical procedure protected by one or more debris protection devices according to an exemplary embodiment.

[0124] Figure 3 shows three columns of blocks: the left column shows steps in the TAVI procedure, the center column shows the corresponding steps of manipulating one or more debris protection devices, and the right column shows potential debris sources at the time corresponding to the steps in the left and center columns.

[0125] The first row 302 shows the steps of obtaining left femoral arterial and venous access for the TAVI device and deploying a debris protection device in the aortic arch.

[0126] The second row 306 shows the steps of the TAVI procedure, including inserting a TAVI guidewire and pigtail via the left femoral artery and inserting a pacer via venous access, and showing that a debris protection device is deployed.

[0127] The third row 310 shows steps in a TAVI procedure, including obtaining right femoral artery access and inserting a guidewire, and shows a debris protection device being deployed with an exemplary hole size of 120 microns, indicating that a potential debris source could be aortic wall debris from deploying the device in the aorta.

[0128] The fourth row 314 shows a step in the TAVI procedure in which the guidewire reaches the left ventricle, and shows a debris protection device being deployed with an exemplary 120 micron pore size, indicating that potential debris sources may be aortic wall debris and aortic valve debris.

[0129] The fifth row 318 shows the insertion step of the TAVI prosthesis delivery system, showing that the debris protection device is deployed with an exemplary 120 micron pore size, indicating that a potential debris source may be aortic wall debris.

[0130] The sixth row 322 shows the positioning step of the TAVI prosthesis delivery system, indicating that a debris protection device can optionally be enabled for smaller hole sizes, for example 30 micron hole sizes, and that a debris capture device can also optionally be enabled to capture debris, indicating that a potential debris source could be aortic wall debris.

[0131] The seventh row 326 shows a step of accelerating the heart rate, called pace up, and indicates that the debris protection device may optionally have a smaller pore size of 30 microns, that the debris capture device may optionally be enabled, and that a potential debris source may be aortic wall debris.

[0132] The eighth row 330 shows the steps of deploying the TAVI prosthesis, indicating that the debris protection device may optionally have a smaller pore size of 30 microns, that the debris capture device may optionally be enabled, and that a potential source of debris may be from covering the aortic valve with the prosthesis.

[0133] The ninth row 334 shows the pace down step after stopping rapid pacing, and indicates that the debris protection device may optionally have a smaller pore size of 30 microns, that the debris capture device may optionally be enabled, and that the potential debris source may be what is now called a debris shower.

[0134] The tenth row 338 shows the optional step of inflating the TAVI balloon if necessary, indicates that the debris protection device may optionally have a smaller pore size of 30 microns, that the debris capture device may optionally be enabled, and that a potential debris source may be what is now called a debris shower.

[0135] The eleventh row 342 shows the step of retrieving the TAVI delivery system from the patient's body, at which point the debris protection device is optionally opened to allow the TAVI delivery system to pass through, indicating that the potential debris source may now be the aortic wall.

[0136] Twelfth row 346 indicates the step of closing the arterial and venous access, at which point the debris protection device is also optionally withdrawn from the patient's body.

[0137] It is expected that many related debris protection devices will be developed during the life of the patent that matures from this application, and the scope of the term debris protection device is intended to pre-emptively include all such new technologies.

[0138] As used herein, "about" and "approximately" mean "within ±25%" with respect to an amount or value.

[0139] The terms "comprising," "including," "having," and conjugations thereof mean "including but not limited to."

[0140] The term "consisting of" means "including and limited to."

[0141] 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.

[0142] 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.

[0143] 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.

[0144] "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.

[0145] 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.

[0146] When a range of values ​​is provided herein (e.g., any set 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 up to," "range up to," or "range including" a first designated number "to" a second designated number (or other similar range terminology) are used interchangeably herein and are meant to include the first and second designated numbers and all fractional and integer numbers therebetween. Unless otherwise indicated, the numbers used herein and any numerical ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors, as understood by those skilled in the art.

[0147] 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.

[0148] 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.

[0149] 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. An activation mechanism for activating a debris protection device related to medical procedures, Includes an expandable anchor stent to which force must be applied in order to activate the debris protection device, Activation mechanism.

2. This further includes automatic disabling based on disabling input. The activation mechanism according to claim 1.

3. The deactivation input includes an input from a timer set to a specific duration for which the debris protection device is activated. The activation mechanism according to claim 2.

4. The aforementioned invalidation input includes input from the pulse rate sensor. The activation mechanism according to claim 2.

5. The aforementioned invalidation input includes input from a blood oxygen sensor. The activation mechanism according to claim 2.

6. An activation mechanism for activating a debris protection device related to medical procedures, The debris protection device is programmed to automatically activate based on the activation input. Activation mechanism.

7. A user interface for managing debris protection devices, The aforementioned user interface is Activation display, Disable display, timer, Display of patient's pulse rate, Display of debris in body fluids, blood oxygen display, Particle representation based on intracranial Doppler, Particle representation based on B-wave Doppler, Particle representation based on spectral Doppler, Particle display based on optical fluid sensors, and, Particle display based on impedance sensors, Includes a display selected from the group consisting of, User interface.

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