Trapped flowing debris in the vena cava

Abstract

1. A device for capturing debris from a blood flow in a blood vessel, the device comprising: an expandable frame having a shape and size to expand against a wall of the blood vessel; a debris blocking portion attached to the frame; and a control wire attached to the debris blocking portion and configured to control opening of the debris blocking portion, the control wire extending upstream from the debris blocking portion relative to the direction of blood flow in the blood vessel. 2. A method for preventing debris from reaching the lungs, the method comprising: inserting a device for capturing debris to a location in a vein, controlling a debris trap in the device to open and collect debris from the vein, performing a medical procedure, and removing the device for capturing debris from the body. 3. Related apparatus and methods are also described.

Description

[Technical Field]

[0001] Related Applications This application is a PCT application claiming priority to U.S. Provisional Patent Application No. 63 / 400,866, filed August 25, 2022, entitled "Trapping Flowing Debris Within a Vena Cava," and U.S. Provisional Patent Application No. 63 / 398,546, filed August 17, 2022, entitled "Trapping Flowing Debris Within Blood Vessels and Other Body Lumens," and is also related to U.S. Provisional Patent Application No. 63 / 400,773, filed August 25, 2022, entitled "Managing Debris Protection Associated with Vascular or Cardiac Medical Procedures," U.S. Provisional Patent Application No. 63 / 400,779, filed August 25, 2022, entitled "Securing a Debris Protection Device Within a Body Lumen," and U.S. Provisional Patent Application No. 63 / 400,771, filed August 25, 2022, entitled "Protection of Coronary Arteries and Myocardial Vascular Vessels During Medical Procedures."

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

[0003] Some embodiments of the present disclosure relate to methods and devices for trapping debris flowing along a vena cava, and more particularly, but not exclusively, to methods and devices for trapping debris flowing along a vena cava with optional control over enabling or disabling of trapping from outside the body, and more particularly, to methods and devices for optionally trapping debris flowing along the inferior vena cava.

[0004] For example, various accidents, wounds, and medical procedures can create debris that travels through the veins to the vena cava and heart, and from the heart to the lungs, causing pulmonary infarction.

[0005] Pulmonary infarction occurs when a pulmonary embolism blocks a blood vessel in the lung, preventing part of the lung tissue from receiving sufficient blood flow and oxygen.

[0006] Approximately 15% to 25% of humans suffer from a heart defect and / or structural difference in the heart called a patent foramen ovale (PFO), a hole between the left and right atria that opens. This hole is present in all fetuses but closes naturally after birth. In patients with a PFO, embolic particles entering the right side of the heart can enter the left side of the heart, endangering cerebral arteries, and can travel via the aortic arch and descending aorta to the renal arteries and distal body organs such as the kidneys, gastrointestinal tract, thoracic and abdominal organs, and lower limbs.

[0007] Certain groups of patients who have a history of or have previously suffered from deep vein thrombosis (DVT) and / or superficial vein thrombosis (SVT) could potentially benefit from protection during injury management, endovascular procedures, or surgical procedures to protect the heart, lungs, and other parts of the body.

[0008] Additional background art includes the following: 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] International Patent Application Publication No. WO2017 / 042808 by Eli describes an embolic protection device including a porous deflection screen that includes a filter and is positioned along the wall of the aortic arch to expand and cover the entrances of arteries branching from the aorta; an embolus collecting portion that includes a cylinder that expands and is positioned along the wall of the descending aorta, and is pressed against the wall of the descending aorta to lock the porous deflection screen; and a connecting portion that connects the porous deflection screen and the embolus collecting portion and is positioned to lock the porous deflection screen against the wall of the aortic arch.

[0010] Debris Heterogeneity across Different Valve Types Captured by a Cerebral Protection System during Transcatheter Aortic Valve Replacement - Focus on Stroke Risk and Prevention, Tobias Schmidt et al., published in J. Am.Coll.Cardiol.Intv.2018 Jul, 11 (13) 1262-1273.

[0011] 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

[0012] The present disclosure relates in some embodiments to methods and devices for trapping debris flowing along venous cavities, particularly the vena cava, and particularly, but not exclusively, to methods and devices for trapping debris flowing along the vena cava, with optional control over enabling or disabling of trapping from outside the body, and more particularly, to methods and devices for optionally trapping debris flowing along the inferior vena cava.

[0013] In accordance with an aspect of some embodiments of the present disclosure, there is provided a device for capturing debris from a blood flow in a vena cava, the device comprising: an expandable frame shaped and sized to expand against a wall of the vena cava; a debris blocking portion attached to the frame; and a control wire attached to the debris blocking portion and configured to control opening of the debris blocking portion.

[0014] According to some embodiments of the present disclosure, the debris blocking portion includes a mesh with holes sized to allow blood to pass through but not allow debris above a certain size to pass through.

[0015] According to some embodiments of the present disclosure, the debris arrestor comprises a plurality of mesh debris traps.

[0016] According to some embodiments of the present disclosure, the expandable frame has a shape and size to expand against the wall of the vena cava.

[0017] According to some embodiments of the present disclosure, the control wire is sized to extend from a location of the device inside the patient's body to outside the patient's body.

[0018] According to some embodiments of the present disclosure, the debris arrestor is arranged to be controlled to open and close from outside the patient's body by the control wire.

[0019] According to some embodiments of the present disclosure, at least some of the mesh debris traps are arranged to be controlled to open and close separately from at least some of the other mesh debris traps.

[0020] According to some embodiments of the present disclosure, a plurality of control wires are provided, each configured to control a separate group of the mesh debris traps.

[0021] According to some embodiments of the present disclosure, the mesh debris trap is positioned in a normally closed state even when the device is expanded against the wall of the body lumen.

[0022] According to some embodiments of the present disclosure, the mesh debris trap is configured to allow passage of a medical instrument through a tubular lumen defined by the interior of the device when the device is expanded against the wall of the vena cava.

[0023] According to some embodiments of the present disclosure, the mesh debris trap comprises a mesh leaf having a base attached to the frame wall and a lip located upstream of the base of the mesh leaf.

[0024] According to some embodiments of the present disclosure, the mesh debris trap comprises a mesh leaf having a base attached to the frame wall and a rim located downstream from the base of the mesh leaf.

[0025] According to some embodiments of the present disclosure, the mesh debris trap includes a marker that allows for detecting whether the mesh debris trap is open or closed.

[0026] According to some embodiments of the present disclosure, the marker comprises a marker suitable for detection by an imaging modality selected from the group consisting of x-ray, ultrasound, and magnetic resonance imaging (MRI).

[0027] According to some embodiments of the present disclosure, the marker is located at a mesh debris trap opening.

[0028] According to some embodiments of the present disclosure, the mesh debris trap is positioned such that mesh debris trap openings are distributed at different distances along the direction of blood flow through the device.

[0029] According to some embodiments of the present disclosure, at least some of the levels of the mesh debris trap are arranged to be enclosed separately from at least some other levels of the mesh debris trap.

[0030] According to some embodiments of the present disclosure, the mesh debris trap comprises a mesh having a pore size ranging from 3000 microns to 2000 microns to 1000 microns to 30 microns.

[0031] According to some embodiments of the present disclosure, the mesh debris trap openings distributed at different distances along the blood flow direction include mesh pore openings of different sizes.

[0032] According to some embodiments of the present disclosure, the mesh debris traps are arranged longitudinally along the device such that, when open, the openings of the open mesh debris traps overlap when viewed along the direction of blood flow.

[0033] According to some embodiments of the present disclosure, the different sized mesh pore openings are arranged such that larger pore sizes are upstream of smaller pore sizes.

[0034] According to some embodiments of the present disclosure, there are at least three levels of mesh pore size: 1000 microns, 400 microns, and 200 microns.

[0035] According to some embodiments of the present disclosure, mesh debris trap openings at the same distance along the blood flow direction include mesh pore openings of different sizes.

[0036] According to some embodiments of the present disclosure, when multiple of the mesh debris traps are open, the open mesh debris traps cover the entire cross-sectional area of ​​the lumen defined by the expandable frame transverse to the direction of blood flow.

[0037] According to some embodiments of the present disclosure, the mesh debris trap opening is configured to conform to the lumen wall when the mesh debris trap is not open.

[0038] According to some embodiments of the present disclosure, the mesh debris trap opening is arcuately shaped.

[0039] According to some embodiments of the present disclosure, the mesh debris trap opening is formed in a triangular shape.

[0040] According to some embodiments of the present disclosure, the mesh debris trap is configured as overlapping leaves.

[0041] According to some embodiments of the present disclosure, the mesh debris trap comprises a filtering mesh.

[0042] According to some embodiments of the present disclosure, a mesh debris trap allows passage of a medical instrument along the device and blocks passage of debris by being placed in contact with the medical instrument.

[0043] According to some embodiments of the present disclosure, the mesh debris trap opening comprises a loop for passing a control wire to open the mesh debris trap.

[0044] According to some embodiments of the present disclosure, the mesh debris trap opening is flexible, allowing surgical instruments to bend through said mesh debris trap opening and pass along the device.

[0045] According to some embodiments of the present disclosure, expansion of the frame against the wall of the vena cava anchors the device and resists movement in the direction of blood flow.

[0046] According to some embodiments of the present disclosure, the device is anchored to resist movement in the direction of blood flow by being connected to an anchoring frame that is extended against the lumen wall upstream of the device.

[0047] According to an aspect of some embodiments of the present disclosure, there is provided a method of collecting debris, the method comprising inserting a device into a vena cava for capturing debris from a fluid flow, locking the device from being moved downstream by the fluid flow, controlling the opening of a mesh debris trap included in the device, and removing the device from the body together with debris captured in the debris trap.

[0048] According to some embodiments of the present disclosure, the locking includes locking downstream of a predicted source of the debris.

[0049] According to some embodiments of the present disclosure, further comprising inserting an instrument along and upstream of the device for performing a medical procedure.

[0050] According to some embodiments of the present disclosure, the medical procedure is performed after the mesh debris trap is opened.

[0051] According to some embodiments of the present disclosure, the device is used in addition to the use of an aortic protection device.

[0052] According to some embodiments of the present disclosure, the method is performed on a patient whose condition is expected to release or generate debris into the veins.

[0053] According to some embodiments of the present disclosure, the method is performed on a patient prior to a medical procedure that is expected to release debris into a vein or that is expected to generate debris in a vein.

[0054] According to some embodiments of the present disclosure, further comprising unlocking the device, repositioning the device, and relocking the device.

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

[0056] According to some embodiments of the present disclosure, closing the mesh debris trap occurs after performing a cardiac procedure.

[0057] According to some embodiments of the present disclosure, opening the mesh debris trap includes controlling only a subgroup of the mesh debris trap.

[0058] According to an aspect of some embodiments of the present disclosure, there is provided a method of collecting debris during a medical procedure, the method comprising inserting a device for trapping debris at a location within a vena cava, inserting a medical instrument for performing the medical procedure, performing the medical procedure, and removing the device for trapping debris from a body with debris trapped in a debris trap within the device.

[0059] According to some embodiments of the present disclosure, further comprising identifying patients who may need protection from debris.

[0060] According to some embodiments of the present disclosure, the identifying is based on a condition of the patient.

[0061] According to some embodiments of the present disclosure, the debris trap within the device is controlled to close prior to the removing.

[0062] According to some embodiments of the present disclosure, the debris trap within the device is controlled to be released prior to performing the medical procedure.

[0063] According to some embodiments of the present disclosure, the medical procedure is a medical procedure selected from the group consisting of vena cava repair, vena cava / venous stenting, pulmonary embolism (PE) removal, right heart medical procedures, pulmonary nerve blockade, electrophysiology procedures, and patent foramen ovale (PFO) procedures.

[0064] According to an aspect of some embodiments of the present disclosure, there is provided a method of preventing debris from reaching the lungs, the method comprising inserting a device for capturing debris into a location within a vein, controlling a debris trap within the device to open and collect debris from the vein, performing a medical procedure, and removing the device for capturing debris from the body.

[0065] According to some embodiments of the present disclosure, prior to removing the device, the debris trap is controlled to be closed.

[0066] According to some embodiments of the present disclosure, the removing includes removing along with debris trapped in a debris trap within the device.

[0067] According to some embodiments of the present disclosure, the method further comprises administering an anticoagulant prior to the removing.

[0068] According to some embodiments of the present disclosure, the debris trap within the device is controlled to be released after or during a procedure selected from the group consisting of a renal procedure, an aneurysm procedure, an injury, an open injury, an amputation, an injury in a disaster situation, a traumatic injury, a blunt traumatic injury, a medical procedure involving cardiac assistance, a medical procedure involving pulmonary assistance, a medical procedure involving Extracorporeal Membrane Oxygenation (ECMO), open surgery, and a pressure injury.

[0069] In accordance with an aspect of some embodiments of the present disclosure, there is provided a device for capturing debris from a blood flow within an aorta, the device comprising: an expandable frame shaped and sized to expand against a wall of a body lumen; a plurality of mesh debris traps attached to the frame; and a control wire attached to one or more of the mesh debris traps and configured to control the opening of the mesh debris traps.

[0070] According to some embodiments of the present disclosure, the expandable frame has a shape and size to expand against the wall of the aorta.

[0071] According to some embodiments of the present disclosure, the expandable frame has a shape and size to expand against the wall of the vena cava.

[0072] According to some embodiments of the present disclosure, the control wire is sized to extend from a location of the device inside the patient's body to outside the patient's body.

[0073] According to some embodiments of the present disclosure, the mesh debris trap is arranged to be controlled to open and close from outside the patient's body by the control wire.

[0074] According to some embodiments of the present disclosure, at least some of the mesh debris traps are arranged to be controlled to open and close separately from at least some of the other mesh debris traps.

[0075] According to some embodiments of the present disclosure, a plurality of control wires are provided, each configured to control a separate group of the mesh debris traps.

[0076] According to some embodiments of the present disclosure, the mesh debris trap is positioned in a normally closed state even when the device is expanded against the wall of the body lumen.

[0077] According to some embodiments of the present disclosure, the mesh debris trap is configured to allow passage of a medical instrument through a tubular lumen defined by the interior of the device when the device is expanded against the wall of the body lumen.

[0078] According to some embodiments of the present disclosure, the mesh debris trap comprises a mesh leaf having a base attached to the frame wall and a lip located upstream of the base of the mesh leaf.

[0079] According to some embodiments of the present disclosure, the mesh debris trap comprises a mesh leaf having a base attached to the frame wall and a rim located downstream from the base of the mesh leaf.

[0080] According to some embodiments of the present disclosure, the mesh debris trap includes a marker that allows for detecting whether the mesh debris trap is open or closed.

[0081] According to some embodiments of the present disclosure, the marker comprises a marker suitable for detection by an imaging modality selected from the group consisting of X-ray, ultrasound, and magnetic resonance imaging (MRI).

[0082] According to some embodiments of the present disclosure, the marker is located at a mesh debris trap opening.

[0083] According to some embodiments of the present disclosure, the mesh debris trap is positioned such that mesh debris trap openings are distributed at different distances along the direction of blood flow through the device.

[0084] According to some embodiments of the present disclosure, at least some of the levels of the mesh debris trap are arranged to be enclosed separately from at least some other levels of the mesh debris trap.

[0085] According to some embodiments of the present disclosure, the mesh debris trap comprises a mesh having a pore size in the range of 1000 to 30 microns.

[0086] According to some embodiments of the present disclosure, the mesh debris trap openings distributed at different distances along the blood flow direction include mesh pore openings of different sizes.

[0087] According to some embodiments of the present disclosure, the mesh debris traps are arranged longitudinally along the device such that, when open, the openings of the open mesh debris traps overlap when viewed along the direction of blood flow.

[0088] According to some embodiments of the present disclosure, the different sized mesh pore openings are arranged such that larger pore sizes are upstream of smaller pore sizes.

[0089] According to some embodiments of the present disclosure, the mesh includes at least three levels of mesh pore size: approximately 3000 microns, 2000 microns, 1000 microns, 400 microns, and 200 microns.

[0090] According to some embodiments of the present disclosure, mesh debris trap openings at the same distance along the blood flow direction include mesh pore openings of different sizes.

[0091] According to some embodiments of the present disclosure, when the plurality of mesh debris traps are opened, the trap openings cover the entire cross-sectional area of ​​the lumen defined by the expandable frame transverse to the direction of blood flow.

[0092] According to some embodiments of the present disclosure, a mesh debris trap opening is configured to conform to the lumen wall when the mesh debris trap is not open.

[0093] According to some embodiments of the present disclosure, the mesh debris trap opening is arcuately shaped.

[0094] According to some embodiments of the present disclosure, the mesh debris trap opening is formed in a triangular shape.

[0095] According to some embodiments of the present disclosure, a mesh debris trap opening comprises a loop for passing a control wire to open said mesh debris trap.

[0096] According to some embodiments of the present disclosure, the mesh debris trap opening is flexible, allowing surgical instruments to bend through said mesh debris trap opening and pass along the device.

[0097] According to some embodiments of the present disclosure, expansion of the frame against the wall of the lumen anchors the device and resists migration in the direction of blood flow.

[0098] According to some embodiments of the present disclosure, the device is anchored to resist movement in the direction of blood flow by being connected to an anchoring frame that is extended against the lumen wall upstream of the device.

[0099] According to some embodiments of the present disclosure, the anchoring frame is shaped and sized to anchor upstream of the brachiocephalic trunk.

[0100] According to some embodiments of the present disclosure, the anchoring frame is shaped and sized to anchor upstream of the carotid artery.

[0101] According to some embodiments of the present disclosure, the device is configured to be attached to an aortic protection device.

[0102] According to some embodiments of the present disclosure, the device is configured as part of an aortic protection device.

[0103] According to an aspect of some embodiments of the present disclosure, there is provided a method of collecting debris, the method comprising inserting into a body lumen a device for capturing debris from a fluid flow, locking the device against downstream movement by the fluid flow, controlling the opening of a mesh debris trap included in the device, and removing the device from the body together with debris captured in the debris trap.

[0104] According to some embodiments of the present disclosure, the locking includes locking downstream of a predicted source of the debris.

[0105] According to some embodiments of the present disclosure, the body lumen is a blood vessel.

[0106] According to some embodiments of the present disclosure, the blood vessel is an artery.

[0107] According to some embodiments of the present disclosure, the artery is the aorta.

[0108] According to some embodiments of the present disclosure, the method further includes inserting an instrument along and upstream of the device for performing a cardiac procedure.

[0109] According to some embodiments of the present disclosure, the method further includes performing the cardiac procedure after opening the mesh debris trap.

[0110] According to some embodiments of the present disclosure, the device is used in addition to the use of an aortic protection device.

[0111] According to some embodiments of the present disclosure, the blood vessel is a vein.

[0112] According to some embodiments of the present disclosure, the method is performed on a patient whose condition is expected to release or generate debris into the veins.

[0113] According to some embodiments of the present disclosure, the method is performed on a patient prior to a medical procedure that is expected to release debris into a vein or that is expected to generate debris in a vein.

[0114] According to some embodiments of the present disclosure, the method further includes unlocking the device, repositioning the device, and relocking the device.

[0115] According to some embodiments of the present disclosure, the method further includes closing the mesh debris trap before removing the device from the body.

[0116] According to some embodiments of the present disclosure, closing the mesh debris trap occurs after performing a cardiac procedure.

[0117] According to some embodiments of the present disclosure, opening the mesh debris trap includes controlling only a subgroup of the mesh debris trap.

[0118] In accordance with an aspect of some embodiments of the present disclosure, there is provided a method of collecting debris during a cardiac procedure, the method comprising inserting a device for capturing debris to a location within an aorta, inserting a medical instrument for performing the cardiac procedure, performing the cardiac procedure, and removing the device from a body with debris captured in a debris trap within the device.

[0119] According to some embodiments of the present disclosure, the debris trap within the device is controlled to close prior to the removing.

[0120] According to some embodiments of the present disclosure, the debris trap within the device is controlled to be released prior to performing the cardiac procedure.

[0121] According to some embodiments of the present disclosure, the cardiac procedure is a cardiac procedure selected from the group consisting of an electrophysiology procedure, a patent foramen ovale (PFO) procedure, a heart valve repair, open heart surgery, a percutaneous aortic valve replacement (PAVR), a percutaneous aortic valve implantation (PAVI), a transcatheter aortic valve implantation (TAVI), and a transcatheter aortic valve replacement (TAVR).

[0122] According to some embodiments of the present disclosure, the debris trap within the device is controlled to be released after or during a procedure selected from the group consisting of an aneurysm procedure, an arteriosclerosis stent procedure, a balloon dilation procedure, a drug delivery procedure, a kidney procedure, a surgical procedure involving treatment of an artery, and an aortic atherosclerosis treatment.

[0123] According to some embodiments of the present disclosure, the cardiac procedure includes a pace-up step, and a cardiac procedure debris trap within the device is controlled to be released after the pace-up step.

[0124] According to some embodiments of the present disclosure, the cardiac procedure includes a pace-down step, and a cardiac procedure debris trap within the device is controlled to be released after the pace-down step.

[0125] According to an aspect of some embodiments of the present disclosure, there is provided a method of preventing debris from reaching the lungs, the method comprising inserting a device for capturing debris into a location within a vein, controlling a debris trap within the device to open and collect debris from the vein, performing a medical procedure, and removing the device for capturing debris from the body.

[0126] According to some embodiments of the present disclosure, prior to removing the device, the debris trap is controlled to be closed.

[0127] According to some embodiments of the present disclosure, the removing includes removing along with debris trapped in a debris trap within the device.

[0128] According to some embodiments of the present disclosure, the method further comprises administering an anticoagulant prior to the removing.

[0129] According to some embodiments of the present disclosure, the debris trap within the device is controlled to be released after or during a procedure selected from the group consisting of a renal procedure, an aneurysm procedure, an injury, an open injury, an amputation, an injury in a disaster situation, an injury due to trauma, an injury due to blunt trauma, a medical procedure involving cardiac assistance, a medical procedure involving pulmonary assistance, a medical procedure involving extracorporeal membrane oxygenation (ECMO), open surgery, and a pressure injury.

[0130] 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.

[0131] Several embodiments of the present disclosure are described, by way of example only, with reference to the accompanying drawings and images. It is emphasized below that the details shown, with particular reference to the drawings, are for the purpose of illustration and for the purpose of providing a 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]

[0132] [Figure 1A] 1 is a simplified block diagram of debris flowing downstream and a device positioned to trap the debris, according to an exemplary embodiment; [Figure 1B] 1 is a simplified block diagram of debris flowing downstream and a device positioned to trap the debris, according to an exemplary embodiment; [Figure 2A] 1 is a simplified schematic diagram of a debris trapping device according to some exemplary embodiments; [Figure 2B] 1 is a simplified schematic diagram of a debris trapping device according to some exemplary embodiments; [Figure 2C] 1 is a simplified schematic diagram of a debris trapping device according to some exemplary embodiments; [Figure 2D] 1 is a simplified schematic diagram of a debris trapping device according to some exemplary embodiments; [Figure 2E] 1 is a simplified schematic diagram of a debris trapping device according to some exemplary embodiments; [Figure 2F] 1 is a simplified schematic diagram of a debris trapping device according to some exemplary embodiments; [Figure 3A] 1 is a simplified schematic diagram of a debris trapping device according to an example embodiment; [Figure 3B] 1 is a simplified diagrammatical schematic diagram of a debris trapping device according to an exemplary embodiment; [Figure 4A] FIG. 2 is a simplified diagram illustrating an example embodiment of a debris trapping device. [Figure 4B] FIG. 2 is a simplified diagram illustrating an example embodiment of a debris trapping device. [Figure 4C] FIG. 2 is a simplified diagram illustrating an example embodiment of a debris trapping device. [Figure 5A] 1 is a photograph of a debris trapping device according to an example embodiment. [Figure 5B] 1 shows a simplified diagram of a debris trapping device according to an example embodiment; [Figure 6A]1 is a photograph of a debris capture device according to an example embodiment; [Figure 6B] 1 is a photograph of a debris capture device according to an example embodiment; [Figure 6C] 1 is a photograph of a debris capture device according to an example embodiment; [Figure 7A] 1 is a simplified diagram of a debris capture device positioned in an aorta according to an exemplary embodiment. [Figure 7B] 1 is a simplified diagram of a debris capture device positioned in an aorta according to an exemplary embodiment. [Figure 7C] 1 is a simplified diagram of a debris capture device positioned in an aorta according to an exemplary embodiment. [Figure 7D] 1 is a simplified diagram of a debris capture device positioned in an aorta according to an exemplary embodiment. [Figure 7E] 1 is a simplified diagram of a debris capture device positioned in an aorta according to an exemplary embodiment. [Figure 7F] FIG. 1 is a simplified diagrammatic view of an aortic protection device deployed in conjunction with a debris trapping device according to one example embodiment of the present invention. [Figure 7G] FIG. 1 is a simplified diagrammatic view of a device including combined aortic protection and debris trapping, according to one example embodiment of the present invention. [Figure 7H] FIG. 1 is a simplified diagrammatic view of a device including combined aortic protection and debris trapping, according to one example embodiment of the present invention. [Figure 7I] 1 is a simplified diagrammatic view of a device including a combination of aortic protection and two positions or levels of debris trapping, according to an exemplary embodiment of the present invention. [Figure 7J] 1 is a simplified diagrammatic view of a device including a combination of aortic protection and two positions or levels of debris trapping, according to an exemplary embodiment of the present invention. [Figure 8] 1 is a simplified diagram of potential locations of a debris trapping device in an aorta, according to some exemplary embodiments. [Figure 9A]1 is a simplified diagram of potential locations of a debris trapping device in a vein, according to some exemplary embodiments. [Figure 9B] 1 is a simplified diagram of a debris trapping device within a vena cava according to an exemplary embodiment. [Figure 9C] 1 is a simplified diagram of a debris trapping device within a vena cava according to an exemplary embodiment. [Figure 9D] 1 is a simplified diagram of a debris trapping device within a vena cava according to an exemplary embodiment. [Figure 9E] 1 is a simplified diagram of a debris trapping device within a vena cava according to an exemplary embodiment. [Figure 9F] 1 is a simplified diagram of a debris trapping device within a vena cava according to an exemplary embodiment. [Figure 9G] 1 is a simplified diagram of a debris trapping device according to some exemplary embodiments; [Figure 9H] 1 is a simplified diagram of a debris trapping device according to some exemplary embodiments; [Figure 9I] 1 is a simplified diagram of a debris trapping device according to some exemplary embodiments; [Figure 9J] 1 is a simplified diagram of a debris trapping device according to some exemplary embodiments; [Figure 9K] 1A-1D are simplified diagrams of various debris trapping devices according to some exemplary embodiments. [Figure 10] FIG. 1 is a simplified flowchart of a method for collecting debris, according to an example embodiment. [Figure 11] 1 is a simplified flowchart diagram of a method for collecting debris during a cardiac procedure, according to an example embodiment. [Figure 12] FIG. 1 is a simplified flowchart diagram of a method for preventing debris from reaching the lungs, according to an example embodiment. [Figure 13A] 1 is a simplified diagram of a patient with an implanted debris trap device, according to an exemplary embodiment. [Figure 13B]1 is a simplified diagram of a control handle or user interface to an implantable debris trap device, according to an exemplary embodiment. [Figure 14A] 1A-1C are simplified diagrams of potential positions of a device for covering and / or sealing a wound in a vein, according to some exemplary embodiments. [Figure 14B] 1A-1C are simplified diagrams of potential positions of a device for covering and / or sealing a wound in a vein, according to some exemplary embodiments. [Figure 14C] 1 is a simplified diagram of a device for covering and / or sealing a wound in a vein, according to some exemplary embodiments. [Figure 14D] 1 is a simplified diagram of a device for covering and / or sealing a wound in a vein, according to some exemplary embodiments. [Figure 15] 1 is a simplified diagram of ejecting debris from a debris-trapping device, according to some exemplary embodiments; [Figure 16A] 1A-1C are simplified diagrams of various debris traps according to some exemplary embodiments. [Figure 16B] 1A-1C are simplified diagrams of various debris traps according to some exemplary embodiments. [Figure 16C] 1A-1C are simplified diagrams of various debris traps according to some exemplary embodiments. [Figure 16D] 1A-1C are simplified diagrams of various debris traps according to some exemplary embodiments. [Figure 16E] 1A-1C are simplified diagrams of various debris traps according to some exemplary embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0133] The present disclosure relates in some embodiments to methods and devices for trapping debris flowing along the vena cava, particularly but not exclusively to methods and devices for trapping debris flowing along the vena cava where the enabling or disabling of trapping is optionally controlled from outside the body, and more particularly to methods and devices for optionally trapping debris flowing along the inferior vena cava.

[0134] The caval debris trap device can be used for controlled protection from embolism and debris migration to the right heart and lungs during a variety of procedures where debris generation is expected.

[0135] The vena cava debris trap device can be used as a first line of defense during endovascular procedures, for deep vein thrombosis patients, abdominal and / or pelvic surgical procedures, venous reconstruction, accidents, war injuries, earthquakes and natural disasters, falls, to name a few non-limiting examples.

[0136] Overview - Introduction The vena cava perfuses / pumps venous blood from distal body organs to the right heart, from which the heart pumps blood into the pulmonary circulation.

[0137] Emboli and / or microemboli and other particles can be swept into the bloodstream in the vena cava and travel to the lungs, causing a pulmonary embolism.

[0138] Patients with deep vein thrombosis (DVT) and / or superficial vein thrombosis (SVT) and / or patent foramen ovale (PFO) and / or a history of pulmonary embolism may be at increased risk for embolic injury.

[0139] Conventional inferior vena cava (IVC) filters are typically designed to trap thrombi with a diameter of 3 to 10 mm and a length of 5 to 20 mm.

[0140] The exemplary debris trapping devices and debris trapping methods described herein allow for trapping of debris and / or thrombus sizes from 200 microns and smaller, including thrombus captured by current IVC filters.

[0141] In some embodiments, the debris trapping device allows for the passage of medical instruments along the device.

[0142] Debris trapping devices placed in the vena cava can be inserted as an option as an early response to stab / gunshot / blast wounds to prevent blood clots from damaging the patient.

[0143] Often, blood-borne debris in the vena cava includes thrombi from extremities of the body, deep vein thrombosis (DVT), superficial vein thrombosis (SVT), and thrombi as a result of injury.

[0144] Patients who are typically susceptible to venous and vena cava involvement include those with a history of DVT, SVT, those prone to thrombus formation, those with coagulation disorders, and those with a history of PE. Special care is available for patients with patent foramen ovale (PFO), who potentially carry a risk of brain injury. Other patient groups include those with military and violent injuries, lacerations of the abdominal and pelvic organs, natural disasters such as earthquakes, floods, and avalanches, and internal and abdominal compression injuries.

[0145] In some embodiments, some or all of these patients are candidates for minimally invasive (catheterization) or surgical options if there is a risk of clots reaching the vena cava traveling to the lungs or brain.

[0146] Some non-limiting examples of suggestions for using the methods and devices for trapping debris flowing along the vena cava described herein include:

[0147] Optionally accessing the vena cava via the femoral vein during an endovascular procedure to trap debris within the vena cava; Trapping debris within the vena cava after trauma that requires treatment of the vena cava itself (which may risk migration of embolic debris into the right heart system); Trapping debris within the vena cava during procedures requiring venous embolic protection; and trapping debris within the vena cava in the case of vena cava obstruction (non-limiting examples of which include compression, tumor, and thrombus treatments such as drug therapy, thrombolytic therapy, and thrombectomy devices).

[0148] Some non-limiting examples of specific patient populations that could potentially benefit from the use of the methods and devices for trapping debris flowing along the vena cava described herein include: Patients with a history of DVT Patients with a history of SVT Patients with a history of PFO in which embolic debris can migrate from the right atrium to the left atrium of the heart, and from there to the cerebral arteries and / or various other body organs; trauma patients, especially where the injury may result in venous embolic debris; Patients with a history of pulmonary embolism, and Patients with a history of venous and / or lymphatic disease.

[0149] Overview - Vena Cava Device Locking An aspect of some embodiments relates to anchoring a vena cava device within a vena cava.

[0150] In some embodiments, the vena cava device is expanded within the vena cava and presses against the side wall of the vena cava, thereby anchoring the device and preventing it from migrating downstream or upstream.

[0151] In some embodiments, the vena cava device is connected to a locking device, which is expanded and pressed against the side wall of the vein (optionally the vena cava), thereby locking the locking device and the vena cava device and preventing the vena cava device from migrating downstream or upstream.

[0152] In some embodiments, the vena cava device is connected to a locking wire that extends to an insertion point within the patient's body (e.g., a jugular vein insertion point or a femoral vein insertion point), and the locking wire prevents the vena cava device from migrating downstream or upstream.

[0153] Overview - Trapped debris in the vena cava An aspect of some embodiments relates to a device for trapping debris flowing through a vena cava.

[0154] In some embodiments the device has a control means that can enable or disable the trap, i.e. enable the debris trap pocket to a state that traps debris and disable it to a state that closes the debris trap pocket, in some embodiments the debris trap pocket comprises a mesh, optionally a flexible mesh, with a particular pore size and is intended to trap debris larger than the particular pore size.

[0155] In some embodiments, the control means extends from the device outside the patient's body, hi some embodiments, the control means is a wire that, when acted upon outside the body, opens and closes the debris trap pocket.

[0156] In some embodiments, when the pocket is closed, any debris within the pocket is retained within the pocket, and the procedure for removing the device from the body also retains the debris within the pocket, allowing the debris to be removed from the body.

[0157] In some embodiments, the pockets are positioned at several distances along the axial direction of the frame. When activated, the pockets optionally extend toward the center of the frame and can optionally completely cover a cross section of the frame at each of several distances (also referred to as several levels) along the axial direction of the frame. A potential advantage of constructing a device with multiple levels of pockets is that the device can be longer and thinner than if the trapped debris was all at one level, as the trapped debris is distributed along the frame, potentially carrying the trapped debris within closed pockets when the device is removed from the body.

[0158] In some embodiments, the control means is configured to control all levels of the pocket. In some embodiments, the control means is configured to control one or more of the levels of the pocket separately from other levels of the pocket. In some embodiments, the control means includes individual controls for each level of the pocket.

[0159] In some embodiments, each of the levels contains pockets made of mesh with different pore sizes. In some embodiments, the levels are arranged such that larger pores are located upstream of smaller pores relative to the direction of flow within the frame. Such embodiments may provide the advantage of trapping debris of different sizes at different distances along the frame, distributing the trapping of different sized debris along different levels, and retaining the trapped debris in closed pockets when the device is removed from the body, allowing the device to be longer and thinner as the debris is distributed than if the trapped debris were all in one level.

[0160] Overview - Potential Access to Vena Cava Devices An aspect of some embodiments relates to an access location within the body where the debris trapping device is inserted.

[0161] In some embodiments, access is via femoral access.

[0162] If access is via a vein in the lower extremity, for example the femoral vein, it is desirable to introduce the vena cava device in the same direction as the blood flow, so as not to oppose the direction of the venous valves.

[0163] In some embodiments, access is via jugular vein access. Note that when using jugular vein access, the patient can potentially move around or get out of bed.

[0164] In some embodiments, access to a chamber or valve of the left heart system is achieved by jugular access, ie, via the jugular vein and then through the right heart system.

[0165] In some embodiments, access is achieved by a hybrid approach (surgery + catheter).

[0166] In some embodiments, the access is by surgery.

[0167] In some embodiments, access is by an approach determined by a physician.

[0168] It should be noted that regardless of the access location, in some embodiments the debris capture device may optionally be placed at a location downstream of the bifurcation of the vena cava.

[0169] Overview - Vena Cava Device Features Additional features related to the vena cava device are listed below.

[0170] In some embodiments, the vena cava device may optionally be placed at an inferior and / or superior level to the kidney.

[0171] In some embodiments, the vena cava device may optionally include two or more permeable filters at one or more levels.

[0172] In some embodiments, the vena cava device can optionally remain in the patient longer than during surgery, for example, for hours, days, or weeks.

[0173] In some embodiments, the vena cava device, like the IVC filter, can optionally be left in the patient longer than during surgery.

[0174] In some embodiments, the vena cava device can optionally be disconnected from the external access and optionally reconnected and retrieved from the patient's body when retrieval is desired.

[0175] In some embodiments, the debris trap opening is flexible, allowing surgical instruments to bend through the debris trap opening and pass along the device.

[0176] In some embodiments, the debris trapping device can be passed along a current or prior art inferior vena cava (IVC) filter.

[0177] In some embodiments, the vena cava device includes a flexible handle, which may optionally be attached to the patient's shoulder or back.

[0178] In some embodiments, the device may optionally be disconnected from the trigger wire and later reconnected, for example, for retrieval.

[0179] In some embodiments, a pusher rod is optionally used for insertion and retrieval of the device. In some embodiments, the pusher rod holds a trigger wire with a recess along the pusher rod. In some embodiments, a lumen within the pusher rod allows for flushing, injection of contrast, and passage of a guidewire.

[0180] In some embodiments, the push rod allows for a preset length to be pushed through an introducer catheter (ranging from 4 French to 12 French in size), and the device can be deployed where the introducer catheter is positioned.

[0181] In some embodiments, the deployment position of the device is optionally verified by ultrasound, fluoroscopy, or MRI.

[0182] In some embodiments, the device includes radiopaque / ultrasound markers on the "leading" tip and filtering element to indicate the deployment point of the device and the location of the filtering element.

[0183] In some embodiments, the proximal and / or distal ends of the device include radiopaque / ultrasound markers to indicate the deployment position of the device.

[0184] In some embodiments, the device may optionally be repositioned within the body.

[0185] In some embodiments, the pore size of the device is optionally preset to 200 microns or greater.

[0186] In some embodiments, the device comprises two or more filtration layers, in some embodiments, different layers are optionally enabled as needed.

[0187] In some embodiments, the inner layer of the device may comprise a shape memory material designed to expand against the wall of a vein, such as a vena cava, and may optionally comprise a shape memory metal.

[0188] In some embodiments, the outer layer of the device may comprise a flexible material suitable for cushioning an inner layer designed to press against the wall of a vein, such as the vena cava.

[0189] In some embodiments, the upstream debris trap optionally includes larger holes for trapping larger debris, and the further downstream debris trap optionally includes smaller holes for trapping smaller debris relative to the larger holes.

[0190] In some embodiments, the pore size range may range from 100 microns to 500 microns.

[0191] In some embodiments, the device includes an impermeable wall and may optionally be used to cover damage to the wall of the vena cava and / or repair tears and / or leaks in the wall of the vena cava.

[0192] In some embodiments, the devices and methods described herein can be used as a first line treatment for vena cava injuries.

[0193] In some embodiments, the device exerts a radial force against the wall of the vena cava to prevent migration / migration, and optionally exerts a substantially uniform radial force against the wall of the vena cava to distribute the force over a large circumference and / or area to avoid trauma to the wall of the vena cava.

[0194] In some embodiments, the device exerts a lower pressure and / or force on the wall of the vena cava compared to the pressure and / or force of a debris trapping device intended for use in the aorta, for example.

[0195] In some embodiments, the device comprises a material approved for use inside a patient's body, such as nitinol, cobalt chromium, or other metals or polymers.

[0196] In some embodiments, the device is formed as a tube with an outer wall made from one of the above materials.

[0197] In some embodiments, the device is formed as a multi-layered tube, with the outer wall consisting of two, three, four, or five or more layers, as some non-limiting examples.

[0198] In some embodiments, the outer layer of the device is optionally made of a polymer, making it soft against the wall of the vein.

[0199] In some embodiments, the device is optionally integrated with a blood pressure sensor, potentially providing an alarm if venous blood flow is obstructed or drops to a dangerous point.

[0200] In some embodiments, the debris trapping device can be exchanged for another debris trapping device to allow other medical instruments to pass alongside the debris trapping device while in place, and a second debris trapping device can be deployed before retrieving the first debris trapping device.

[0201] In some embodiments, the debris trapping device is optionally placed in the deep veins of the legs, for example, during treatment of insufficient deep vein valves, backflow of blood, deep vein thrombosis (DVT), injuries, malformations, and other procedures.

[0202] In some embodiments, the debris trapping device is optionally enabled to block blood flow to the heart, typically for a short period of time (e.g., for purposes of a medical procedure and / or during surgery).

[0203] Overview - Use of vena cava devices to seal venous wounds One aspect of some embodiments relates to covering and / or sealing a venous wound (for some non-limiting examples, a femoral vein or vena cava wound), for example, by advancing a vena cava device as described herein.

[0204] The devices described herein can be guided to the location of a wound in a vein and expanded to cover and / or seal the wound.

[0205] Overview - Device Embodiments An aspect of some embodiments relates to a device for trapping debris flowing through a lumen in a body (eg, debris flowing within a blood vessel).

[0206] 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.).

[0207] In some embodiments the device has controls that can enable or disable the trap, i.e. enable the debris trap pocket to a state where it traps debris and disable the debris trap pocket to a closed state, In some embodiments the debris trap pocket comprises a mesh, optionally a flexible mesh, with a particular pore size and is intended to trap debris larger than the particular pore size.

[0208] Throughout this specification and claims, the term "mesh" means a material that has holes or apertures that allow particles smaller than the holes or apertures to pass through.

[0209] Throughout this specification and claims, the term "mesh" is used interchangeably with the terms membrane, film, knit, polymer, electrospun polymer, nitinol mesh, and biodegradable membranes of polymeric and / or biological origin.

[0210] In some embodiments, the control means extends from the device outside the patient's body, hi some embodiments, the control means is a wire that, when acted upon outside the body, opens and closes the debris trap pocket.

[0211] In some embodiments, when the pocket is closed, any debris within the pocket is retained within the pocket, and the procedure for removing the device from the body also retains the debris within the pocket, allowing the debris to be removed from the body.

[0212] In some embodiments, the device has a debris trap pocket disposed along the inner periphery of the frame. When the pocket is activated (i.e., opened), the pocket optionally extends toward the center of the frame and optionally completely covers a cross section of the frame. In some embodiments, when the pocket extends toward the center of the frame, the pocket is sufficiently flexible to accommodate a medical instrument extending through the frame and optionally seals the cross section of the frame against the medical instrument. In some embodiments, when the pocket extends toward the center of the frame, the pocket is sufficiently flexible to accommodate a medical instrument extending through the frame and optionally seals the cross section of the frame against the medical instrument.

[0213] In some embodiments, the debris trap pocket is normally closed, i.e., fluid can pass through the debris trap pocket with low resistance and fluid is not filtered through the debris trap pocket. A closed debris trap pocket is also referred to as a state in which the device for capturing debris is open (not enabled to trap debris). A potential advantage of such an embodiment is that fluid flow is unimpeded until something occurs that causes debris to be filtered and / or trapped. In some embodiments, the trap may only be enabled during medical procedures known to generate debris. One non-limiting example of such a use is when the device is placed in the aorta and enabled during a cardiac procedure or during pacing down after a cardiac procedure, when blood flow is known to increase and debris flow is likely to increase. Allowing blood to flow unimpeded until a time known or suspected to cause an increase in debris flow downstream is potentially advantageous.

[0214] In some embodiments, the debris trap pocket is normally open, i.e., fluid is filtered through it. An open state of the debris trap pocket means that the debris capture device is enabled to trap debris. A potential advantage of such an embodiment is that there is no need to determine when to initiate trapping, since fluid is constantly filtering through and trapping debris. In some embodiments, the trapping may last for all or most of the time the device is deployed in place. One non-limiting example of such a use is when the device is placed in a vein to prevent debris from reaching the patient's lungs. In some embodiments, the device is optionally placed in the veins of a patient who has suffered an accident that crushes a limb. Such accidents are known to generate blood clots and / or other debris that can travel to the lungs, and the device can be used in a vein, such as a vena cava, to trap debris and prevent it from reaching the lungs. In some embodiments, such prevention can last throughout a medical procedure performed on the patient, if there is concern that the procedure will generate debris.

[0215] In some embodiments, the debris trap pocket is opened and enabled to filter and / or trap debris from the fluid flow, in some embodiments, enabling requires the physician to continuously apply force to hold the debris trap pocket open, and when the physician ceases applying force, the debris trap pocket closes.

[0216] In some embodiments, the pockets are positioned at several distances along the axial direction of the frame. When activated, the pockets optionally extend toward the center of the frame and can optionally completely cover a cross section of the frame at each of several distances (also referred to as several levels) along the axial direction of the frame. A potential advantage of constructing a device with multiple levels of pockets is that the device can be longer and thinner than if the trapped debris were all at one level, as the trapped debris is distributed along the frame, potentially carrying the trapped debris within closed pockets when the device is removed from the body.

[0217] In some embodiments, the control means is configured to control all levels of the pocket. In some embodiments, the control means is configured to control one or more of the levels of the pocket separately from other levels of the pocket. In some embodiments, the control means includes individual control means for each level of the pocket.

[0218] In some embodiments, each of the levels contains pockets made of mesh with different pore sizes. In some embodiments, the levels are arranged such that larger pores are located upstream of smaller pores relative to the direction of flow within the frame. Such embodiments may provide the advantage of trapping debris of different sizes at different distances along the frame, distributing the trapping of different sized debris along different levels, and retaining and carrying the trapped debris within closed pockets when the device is removed from the body, allowing the device to be longer and thinner as the debris is distributed than if the trapped debris were all in one level.

[0219] In some embodiments, the device for trapping debris in the vena cava allows passage of a medical instrument (such as, by way of non-limiting example, an intravascular instrument) through the device when the device is in the vena cava.

[0220] In some embodiments, a device for trapping debris in a vena cava allows passage of a medical instrument (such as, by way of non-limiting example, an intravascular instrument) through the device when the device is activated and / or anchored and / or deployed in the vena cava.

[0221] In some embodiments, devices for trapping debris within the vena cava are deployed and / or retrieved through small-caliber entry points such as, for example, femoral and / or jugular access.

[0222] Overview – Potential Locations of Devices An aspect of some embodiments relates to the location of a lumen within the body where a device for trapping debris flowing through the lumen is located.

[0223] Typically, the device includes a frame that can expand to the diameter of the lumen and expands to press against the lumen wall. In some embodiments, expansion causes the frame to seal against the lumen wall, preventing debris from flowing between the frame and the lumen wall. In some embodiments, expansion locks the frame in place and prevents it from sliding along the lumen wall, even when a debris-trapping pocket is engaged and fluid flow along the lumen could apply pressure to the pocket and push the frame downstream.

[0224] Some non-limiting exemplary locations are described with respect to trapping debris in the bloodstream, where the lumen through which the blood flows is an artery and / or vein.

[0225] An exemplary location may be the descending aorta, which is an artery with a relatively large diameter and a relatively long lumen for placement of an embodiment of the device.

[0226] An exemplary location may be the abdominal aorta.

[0227] Thus, embodiments of the device may include one or more levels of debris trapping pockets and may therefore be short or long and suitable for different locations, for example, when placed in the descending aorta, embodiments of the device may include multiple levels of pockets.

[0228] An exemplary location may be the aortic arch, where the descending aorta is an artery with a relatively large diameter and curved portion of the lumen for placement of an embodiment of the device.

[0229] An exemplary location may be, for example, the ascending aorta between the cardiac arteries and the brachiocephalic trunk.

[0230] An exemplary location is the vena cava where blood enters the heart before being pumped to the lungs, where debris can cause significant damage.

[0231] Overview - Non-limiting examples of usage An aspect of some embodiments relates to a method of using a debris trapping device.

[0232] In some embodiments, the device is inserted into the body and advanced along a body lumen to a predetermined location. Once the device is in place, a frame included in the device expands and presses against the lumen wall. By way of non-limiting example, the frame may comprise a shape-memory material, and the frame expands as it is pushed out of the catheter.

[0233] In some embodiments, a catheter is used to insert the device into the body. In some embodiments, the catheter may optionally be a standard vascular access catheter. Contemplated catheter diameters include those ranging from 5 French to 12 French. In some embodiments, the catheter may optionally be a small-bore femoral access catheter. Contemplated catheter diameters include those ranging from 5 French to 8 French.

[0234] In some embodiments, the device is designed for radial access.

[0235] In some embodiments, the debris trapping device is optionally inserted through the same femoral access as the instruments for the additional medical procedure (such as a balloon frame graft) or through the patient's other leg, i.e., a femoral access that is not via the same leg as the access for the additional medical procedure.

[0236] Optionally, in some embodiments, a medical instrument may be passed through and / or alongside the debris trapping device in order to perform a medical procedure upstream of the debris trapping device.

[0237] If appropriate, a debris trap pocket is optionally enabled when debris needs to be trapped. In some embodiments, the pocket extends toward the center of the frame to cover a cross-section of the lumen, and all fluid flowing along the lumen passes through the debris trap pocket. In some embodiments, the pocket extends toward the center of the frame and is positioned to fit snugly along a catheter used to direct medical instruments upstream through the device, closing off a cross-section of the lumen, so that fluid flowing along the lumen passes through the debris trap pocket.

[0238] A typical time when debris trapping is required is during a surgical procedure or other medical procedure that may release debris particles.

[0239] As a non-limiting example, the debris trapping device is optionally activated when surgery is performed on the heart (for non-limiting example, the mitral valve). Such surgery may release sediment particles that may have accumulated on the mitral valve. Optionally, such particles are trapped rather than allowed to flow along the arteries (where they could reach and damage the kidneys, brain, or heart).

[0240] As a non-limiting example, the debris trapping device is optionally activated when a therapeutic procedure is performed on the body, which may release emboli such as blood clots, but optionally trap such particles before they enter the right side of the heart instead of allowing the heart to pump them towards the lungs, where they may be damaged.

[0241] Overview – Medical Use An aspect of some embodiments includes using a debris trapping device downstream of a location where a medical procedure is performed. In some embodiments, the medical procedure may release debris to flow with bodily fluids (such as, by way of non-limiting example, blood), and the debris trapping device is optionally enabled before the medical procedure begins to trap the debris and prevent it from flowing and reaching a location within the body where it may cause harm.

[0242] In some embodiments, when a medical procedure is performed on the heart, an embodiment of a debris trapping device is optionally deployed downstream of the heart, for example in the aorta, to trap debris generated by the procedure.

[0243] As a non-limiting example, debris trapping devices are optionally enabled when surgery is performed on the mitral valve. Such surgery typically releases sediment particles that may have accumulated on the mitral valve, trapping them rather than allowing them to flow along the arteries (where they could reach and damage the kidneys, brain, or heart).

[0244] In some embodiments, when a medical procedure is performed on the body, debris may be released and travel along the veins toward the heart. The debris may include emboli, such as blood clots. If debris is allowed to enter the heart from the venous system, the heart pumps the debris toward the lungs. Emboli in the lungs can cause damage. In some embodiments, a debris trapping device is placed at the entrance to the heart, for example, at the vena cava, to prevent debris from entering the heart and traveling toward the lungs. In some embodiments, the intravenous debris trapping device is optionally enabled before starting the medical procedure.

[0245] In some embodiments, when a body is involved in an accident, blood clots may accumulate in the body part involved in the accident. A debris trapping device may optionally be placed at the entrance to the heart, for example, at the vena cava, to prevent debris from entering the heart and continuing toward the lungs. In some embodiments, the intravenous debris trapping device is optionally activated before commencing medical surgery aimed at treating the body part damaged in the accident.

[0246] Overview - Relationship with other devices An aspect of some embodiments relates to a debris trapping device that is attached to and / or integrally constructed with an additional medical device.

[0247] As a non-limiting example, one embodiment of the debris trapping device may optionally be attached to and / or be part of an aortic protection device such as that described in the above-referenced International Patent Application Publication No. WO 2019 / 064223 to Brandeis.

[0248] An aspect of some embodiments relates to a debris trapping device that is used in addition to the use of additional medical equipment.

[0249] As a non-limiting example, one embodiment of the debris trapping device may be used as an option in addition to using the aortic protection device described in the above-mentioned International Patent Application Publication No. WO2019 / 064223 to Brandeis.

[0250] By way of non-limiting example, one embodiment of the debris trapping device may be used as an option in addition to the equipment used in the procedure also known as Percutaneous Aortic Valve Replacement (PAVR), Percutaneous Aortic Valve Implantation (PAVI), Transcatheter Aortic Valve Implantation (TAVI), or Transcatheter Aortic Valve Replacement (TAVR).

[0251] In some embodiments, the debris trapping device is optionally deployed first, and the instrument optionally passes through the debris trapping device. In some embodiments, the instrument optionally passes through the debris trapping device even while the debris trapping pocket is activated. In some embodiments, the edges or edges of the pocket are flexible enough to allow the instrument to pass through, optionally maintaining contact with the instrument, filtering the blood and potentially trapping debris.

[0252] Before describing at least one embodiment of the present disclosure in detail, it is to be understood that the present 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 present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0253] Reference is made to FIG. 1A, which is a simplified block diagram illustrating debris flowing downstream and devices positioned to trap the debris, according to an exemplary embodiment.

[0254] FIG. 1A shows one debris source 102 (e.g., a calcified heart valve releasing calcium fragments during a medical procedure, or a blood embolus from shattered tissue) that releases debris 104 that flows along a body lumen 101 (e.g., an artery such as the aorta, or a vein such as a vena cava). The debris reaches a debris capture device 106. Downstream of the debris capture device 106, fluid (e.g., blood) now depleted of some or all of the debris trapped by the debris capture device 106 continues to form a flow 108. The fluid reaches an organ 110 that could potentially benefit from being freed from the debris. Such organs could be the lungs (in which case the debris capture device 106 is placed in a vein, optionally a vena cava), the heart, and / or the brain (in which case the debris capture device 106 is placed in the aorta), and / or the kidneys (in which case the debris capture device 106 is placed in the aorta or abdominal aorta), to name a few non-limiting examples.

[0255] In some embodiments, the debris capture device 106 optionally has at least two states: an open state that does not trap debris and allows fluid to pass with maximum flow and minimum resistance to flow, and a closed state that captures debris and allows cleaner fluid with less or no debris to pass through to reach the organ 110.

[0256] In some embodiments, the debris capture device 106 includes debris trapping leaves or pockets that extend across the cross section of the debris capture device 106, and the trapping leaves or pockets include a mesh material that filters fluid and prevents debris from passing through.

[0257] The mesh material may include mesh with pore sizes of 3000 microns, 1000 microns, 200 microns, 150 microns, 130 microns, 100 microns, 75 microns, 50 microns, 30 microns, and may include mesh with a minimum of 10 microns.

[0258] Optionally, in some embodiments, the debris capture device 106 is controlled 114 by a controller 116 to switch between two states.

[0259] Optionally, in some embodiments, the controller 116 is enabled by a physician.

[0260] In some embodiments, the controller 116 is operatively connected to the sensors and is optionally automatically enabled by programming the enabling of the debris trapping device 106 based on the sensor readings.

[0261] As one non-limiting example, during a TAVI procedure, the heart is artificially paced (called pace-up) to cause the heart to pump less blood before implantation of the aortic valve begins. The implantation process can release debris into the bloodstream. At such times (pace-up), it may be desirable for the debris capture device 106 to be automatically enabled to capture debris and prevent it from flowing downstream toward organs that could potentially be affected by debris in the blood.

[0262] As one non-limiting example, during a TAVI procedure, post-implant, the heart may be slowed down (called pace-down) to allow the heart to pump more blood. The increased blood flow may cause debris to escape from the site of the medical procedure. At such times (pace-down), it may be desirable for the debris capture device 106 to be automatically enabled to capture debris and prevent it from flowing downstream toward organs that may potentially be affected by debris in the blood.

[0263] Sensors that can be used to automatically activate the debris capture device 106 include sensors that provide heart rate.

[0264] In some embodiments, the heart rate sensor may optionally be located separately from the debris capture device 106 and provide data to the controller 116 .

[0265] In some embodiments, a physician manually enables and / or disables the controller 116, whether following the principles for automatic enablement described above or principles related to the method of a particular medical procedure.

[0266] In some embodiments, a physician manually enables and / or disables the controller 116 based on specific activities associated with the medical procedure being performed. As one non-limiting example, when a medical instrument is moved along a lumen, e.g., the aorta, the movement may release particles, and the debris trapping device may optionally be enabled to trap the particles. As another non-limiting example, when a medical instrument is being repositioned, the movement may release particles, and the debris trapping device may optionally be enabled to trap the particles. As yet another non-limiting example, when a balloon is planned to be inflated, the inflation may release particles, and the debris trapping device may optionally be enabled to trap the particles.

[0267] In some embodiments, the controller 116 may optionally be a control wire 116. In some embodiments, the control wire 116 is optionally attached at one end to the debris trapping device 106 and extends at the other end outside the patient's body.

[0268] Reference is now made to FIG. 1B, which is a simplified block diagram illustrating debris flowing downstream and devices positioned to trap the debris, according to an exemplary embodiment.

[0269] 1B shows one debris source 122 that emits debris that flows 124 along a body lumen 121. The debris reaches a debris trapping device 126 that includes several (two or more) debris-trapping traps 126A, 126B or groups of traps 126A, 126B. Downstream of the first debris-trapping trap 126A, the fluid continues to flow 128A, minus some or all of the debris trapped by the debris-trapping trap 126A.

[0270] In some embodiments, the flow 128A reaches a second debris trap 126B, after which the fluid continues into flow 128B, minus some or all of the debris trapped by the debris trap 126B.

[0271] In some embodiments, the upstream debris trap 126A may optionally have pores, for example, about 0.5 millimeters in size, or in the range of about 200 microns to about 500 microns, and / or the leaves of the debris trap may be longer than the downstream debris trap 126 to trap larger debris and / or present less obstruction to blood flow, and the further downstream debris trap 126B may optionally have pores, for example, about 100 microns in size, or in the range of about 50 microns to about 150 microns, to trap smaller debris.

[0272] The fluid reaches organs 130 that potentially benefit from being kept out of reach of debris.

[0273] In some embodiments, the debris capture device 126 is optionally controlled 134A, 134B by one or more controllers 136A, 136B to switch between an OPEN state and a CLOSED state.

[0274] In some embodiments, the debris capture device 126 is optionally controlled by a single controller.

[0275] In some embodiments, one or more of the debris-trapping traps 126A, 126B, or one or more groups of traps 126A, 126B, are optionally controlled separately. In some embodiments, the debris-trapping traps 126A, 126B, or groups of traps 126A, 126B, are controlled independently of each other.

[0276] In some embodiments, the physician optionally inserts a tube (not shown) through a vein to the upstream debris trap 126A, and optionally aspirates debris from the upstream debris trap 126A out of the patient's body.

[0277] In some embodiments, the physician optionally inserts a tube (not shown) through a vein to the downstream debris trap 126B, and optionally aspirates debris from the downstream debris trap 126b out of the patient's body.

[0278] In some embodiments, the physician optionally inserts tubing (not shown) through the same vein and / or the same access route to the upstream debris trap 126A and / or the downstream debris trap 126B.

[0279] Reference is made to Figures 2A-2F, which show simplified schematic diagrams of debris trapping devices according to some exemplary embodiments.

[0280] Figure 2A shows a debris capture device 204 that includes a frame 206 having leaves 208, debris traps 208, or debris collection pockets 208 that can be opened (sealed against the walls of the frame 206) and closed (bent toward the center of the lumen defined by the frame 206). Figure 2A also shows optional wire(s) 210 that, in some embodiments, are used to control activation of the debris collection pockets 208. Figure 2A also shows the direction of fluid flow 202.

[0281] FIG. 2A shows a debris capture device 204 with the base of the leaves 208 attached to a frame 206 and the free edges of the leaves 208 facing upstream relative to the direction of fluid flow 202. FIG.

[0282] Figure 2B shows a debris capture device 214 that includes a frame 206 having leaves 218 or debris traps 218 or debris collection pockets 218 that can be open (sealed against the walls of the frame 206) and closed (bent towards the center of the lumen defined by the frame 206). Figure 2B also shows optional wire or wires 210 that, in some embodiments, are used to control activation of the debris collection pockets 218. Figure 2B also shows the direction of fluid flow 202.

[0283] FIG. 2B shows the debris capture device 214 with the base of the leaf 218 attached to the frame 206 and the free edge of the leaf 218 facing downstream relative to the direction of the fluid flow 202 .

[0284] Figure 2C shows a debris capture device 224 that includes a frame 206 with leaves or debris traps or debris collection pockets 228, 229 at two different levels relative to the direction of fluid flow 202 along the lumen defined by the frame 206. The leaves or debris traps or debris collection pockets 228, 229 can be open (sealed against the wall of the frame 206) and closed (bent towards the centre of the lumen defined by the frame 206). Figure 2C also shows an optional wire or wires 210 that, in some embodiments, are used to control activation of the debris collection pockets 228, 229.

[0285] FIG. 2C shows the debris capture device 224 with the base of the leaf 228 attached to the frame 206 and the free edge of the leaf 228 facing upstream relative to the direction of the fluid flow 202.

[0286] Figure 2D shows a debris capture device 234 that includes a frame 206 with leaves or debris traps or debris collecting pockets 238, 239 at two different levels relative to the direction of fluid flow 202 along the lumen defined by the frame 206. The leaves or debris traps or debris collecting pockets 238, 239 can be open (sealed against the wall of the frame 206) and closed (bent towards the center of the lumen defined by the frame 206). Figure 2D also shows an optional wire or wires 210 for controlling activation of the debris collecting pockets 238, 239 in some embodiments.

[0287] 2D shows a debris capture device 234 in which the bases of leaves 238 are attached to the frame 206 with the free edges of leaves 238 facing upstream relative to the direction of fluid flow 202, and the bases of leaves 239 are attached to the frame 206 with the free edges of leaves 239 facing downstream relative to the direction of fluid flow 202. The two levels of leaves 238, 239 face in different directions with the free edges facing each other.

[0288] Figure 2E shows a debris capture device 244 that includes a frame 206 with leaves or debris traps or debris collecting pockets 248, 249 at two different levels relative to the direction of fluid flow 202 along the lumen defined by the frame 206. The leaves or debris traps or debris collecting pockets 248, 249 can be open (sealed against the wall of the frame 206) and closed (bent towards the center of the lumen defined by the frame 206). Figure 2D also shows an optional wire or wires 210 for controlling activation of the debris collecting pockets 248, 249 in some embodiments.

[0289] 2D shows a debris capture device 244 in which the base of leaf 248 is attached to the frame 206 with the free edge of leaf 248 facing downstream relative to the direction of fluid flow 202, and the base of leaf 249 is attached to the frame 206 with the free edge of leaf 249 facing upstream relative to the direction of fluid flow 202. The two levels of leaves 248, 249 point in different directions with the free edges pointing away from each other.

[0290] 2F shows a debris capture device 254 that includes a frame 206 with leaves or debris traps or debris collecting pockets 258, 259 at two different levels relative to the direction of fluid flow 202 along the lumen defined by the frame 206. The leaves or debris traps or debris collecting pockets 258, 259 can be open (sealed against the wall of the frame 206) and closed (curved towards the center of the lumen defined by the frame 206).

[0291] FIG. 2F shows the debris capture device 254 with the bases of the leaves 258 , 259 attached to the frame 206 and the free edges of the leaves 258 , 259 facing downstream relative to the direction of the fluid flow 202 .

[0292] FIG. 2F is also intended to illustrate that the length of a leaf 258 at one level may not be equal to the length of a leaf 259 at another level.

[0293] As shown in Figures 2C to 2E, there may be more than one level of leaves.

[0294] In some embodiments, different levels of debris-trapping leaves or pockets may have different pore sizes in the mesh through which the leaves filter fluid and trap debris.

[0295] In some embodiments, the different pore sizes at the different levels are arranged such that the larger pore sizes are located upstream of the smaller pore sizes.

[0296] Potentially, one or more potential advantages may be realized by trapping different sizes of debris at different levels.

[0297] Debris of different sizes is trapped at different levels. When the debris trap is closed and the device is optionally removed from the patient's body, the debris can be distributed along different levels depending on the debris size, so that removal is of a longer, thinner device, less likely to potentially injure the patient.

[0298] Trapping smaller sized debris by filtering through smaller pore sizes can impede fluid flow, e.g., blood flow, and can have adverse effects on the patient. In some embodiments, smaller pore sizes can be used for the shortest possible time when maximum debris flooding is expected, and larger pore sizes can be used for longer periods of time to prevent larger debris particles from flowing downstream.

[0299] In some embodiments, the different pore sizes of the different traps are controlled separately, with larger pore size traps being controlled separately from smaller pore size traps.

[0300] In some embodiments, the different pore sizes at the different levels are controlled separately, with larger pore sizes being controlled separately from smaller pore sizes.

[0301] In some embodiments, during a medical procedure, a physician selects when and with which pore size traps to activate.

[0302] Reference is made to FIG. 3A, which is a simplified schematic diagram of a debris trapping device according to an exemplary embodiment.

[0303] FIG. 3A shows a debris capture device 302 including a frame 304 and debris capture leaves 306 that are open in an activated state.

[0304] FIG. 3A shows a cross section of the debris capture device 302 along the lumen defined by the frame 304, parallel to the direction of fluid flow or opposite to the direction of fluid flow.

[0305] FIG. 3A shows that in some embodiments, when the debris trapping leaves 306 are open, the entire cross-sectional area of ​​the debris trapping device 302 is covered.

[0306] In some embodiments, the debris capture leaves 306 are covered with a mesh having a pore size selected according to the size of debris that should not pass through the debris capture device 302 .

[0307] FIG. 3A also shows that a medical instrument can pass through the center 308 of the debris capture device 302, displacing the debris capture leaves 306, if desired.

[0308] In some embodiments, the debris capture leaves 306 are flexible and fit snugly against the medical device, continuing to filter fluid and providing filtration of a cross-sectional area around the medical device.

[0309] Reference is made to FIG. 3B, which is a simplified schematic diagram of a debris trapping device according to an exemplary embodiment.

[0310] FIG. 3B shows a debris capture device 312 including a frame 314 and debris capture leaves 316, 318 that are open in an activated state.

[0311] FIG. 3B shows a cross section of the debris capture device 312 parallel to the direction of fluid flow, either in the direction of fluid flow or opposite to the direction of fluid flow, along the lumen defined by the frame 314.

[0312] FIG. 3B shows that in some embodiments, when the debris trapping leaves 316, 318 are opened, the entire cross-sectional area of ​​the debris trapping device 312 is covered.

[0313] In some embodiments, the debris capture leaf 316 is covered by a mesh having a first pore size and the debris capture leaf 318 is covered by a mesh having a second, different pore size.

[0314] In some embodiments, it is sufficient for one group of debris trapping leaves (e.g. only debris trapping leaves 316 or only debris trapping leaves 318) to be open in order to cover the entire cross-sectional area of ​​the debris trapping device 312.

[0315] In some embodiments, debris trapping leaves with meshes of different hole sizes are optionally separately controllable: the debris trapping device 312 may be enabled with only a first hole size, or only a second hole size, or both hole sizes.

[0316] As a non-limiting example, a 200 micron hole size can optionally be used to protect downstream locations of the debris trapping device.

[0317] By way of non-limiting example, pore sizes of 100 microns or less, e.g., 30 microns, may optionally be used to protect locations downstream of the debris capture device in certain medical indications, such as protecting the kidneys in patients where the kidneys are at particular risk, protecting the liver in patients where the liver is at particular risk, protecting the pelvic organs in patients where the pelvic organs are at particular risk, protecting the lungs by preventing debris from entering the right ventricle of the heart and from there into the lungs in medical procedures on the extremities, pelvis, etc.

[0318] FIG. 3B also shows that a medical instrument can pass through the center of the debris capture device 312, pushing the debris capture leaves 316, 318 aside, if desired.

[0319] In some embodiments, one or more of the debris-trapping leaves 316, 318 are optionally controlled to change the pore size of the mesh of the debris-trapping leaves 316, 318. By way of non-limiting example, the debris-trapping leaves 316, 318 may optionally be lengthened, for example, by pulling on the free edge or tip of the debris-trapping leaf 316, 318. When the free edge or tip of the debris-trapping leaf 316, 318 is pulled and the leaf is stretched, the pores are reformed and smaller debris particles are optionally trapped by the debris-trapping leaf 316, 318.

[0320] Reference is made to Figures 4A-4C, which are simplified diagrammatic illustrations of one example embodiment of a debris trapping device.

[0321] FIG. 4A shows a debris capture device 402 having a frame 404 with leaves 406 or debris traps 406 or debris collecting pockets 406 .

[0322] FIG. 4A shows that the tips 408 of the leaves 406 optionally contact the medical implement 407 passing through the debris capture device 402 .

[0323] FIG. 4A also shows an exemplary direction of fluid flow 401.

[0324] In some embodiments, the debris-collecting pocket 406 optionally includes a marker that allows for detection of whether the debris trap is open or closed. In some embodiments, the marker is suitable for detection by various imaging modalities, such as x-ray and / or ultrasound and / or magnetic resonance imaging (MRI). In some embodiments, the marker is optionally located at the tip 408.

[0325] FIG. 4A shows one embodiment of a debris trap having a central leading edge 408 of the trap and a debris trap or debris pocket lip 409 that extends towards the wall of the frame 404 .

[0326] Figure 4B shows a portion of the debris capture device 402, including one wall of the frame 404 and one of the leaves 406. Figure 4B shows a pocket 410 or debris trap 410 into which debris can flow with the fluid flow 401. The leaf 406 allows the fluid to pass through, trapping debris particles larger than the size of the mesh pores on the leaf in the pocket-like trap 410.

[0327] When the debris trapping device 402 is optionally disabled, the trap is closed and contains the debris trapped within the trap.

[0328] In some embodiments, the debris trapping device 402 is optionally removed from the patient's body along with the trapped debris.

[0329] 4C shows a cross section of the frame 404 and one of the debris trapping traps 410 of the debris trapping device 402. The debris trap 410 is shown open and extending towards the centre of the frame 404.

[0330] In some embodiments, the debris trap 410 may extend beyond the center of the frame 404, but is flexible enough to allow a medical instrument to push the debris trap 410 aside slightly to pass through.

[0331] In some embodiments, when the multiple debris trapping traps 410 are opened, the debris trapping traps 410 optionally cover the entire cross section of the frame 404 and allow the medical instrument to pass through the debris trapping traps 410 with only a slight push past them.

[0332] In some embodiments, the debris trapping traps 410 may extend to the center of the frame 404 or may not reach the center of the frame 404, and when some of the debris trapping traps 410 are opened, the debris trapping traps 410 optionally cover the entire cross section of the frame 404, allowing medical instruments to pass through the debris trapping traps 410 with only a slight push past them.

[0333] FIG. 4C shows a view along the direction of fluid (eg, blood) flow, illustrating that debris flowing along the device is likely to be trapped by debris trap 410.

[0334] When the debris capture device 402 comprises a plurality of open debris traps 410 covering the entire cross section of the frame 404, Figures 4A-4C show that debris larger than the mesh hole size of the debris traps 410 will be captured by the debris traps 410.

[0335] When the debris capture device 402 comprises multiple open debris traps 410, even if the traps are pushed aside by the medical instrument, the debris mesh traps 410 cover the cross-sectional area of ​​the frame 404 that is not occupied by the medical instrument, and debris larger than the mesh hole size of the debris traps 410 is captured by the debris traps 410.

[0336] Reference is made to FIG. 5A, which is a photograph of a debris trapping device according to an exemplary embodiment.

[0337] FIG. 5A shows a debris capture device 500 comprising a frame 502 and leaves 504 or debris traps 504 or debris collecting pockets 504 .

[0338] FIG. 5A does not show the mesh covering the leaves 504.

[0339] 5A shows an optional narrowing end 506 of the debris capture device 500. The narrowing end 506 allows the debris capture device 500 to be pulled into a catheter for removal from a patient's body. The narrowing end 506 can potentially pull the device 500 into the catheter and aid in compressing the device as it enters the catheter.

[0340] In some embodiments, the debris trap 504 confines the debris that it has trapped as the device 500 is retracted into a catheter and removed from the body along with the trapped debris.

[0341] Reference is now made to FIG. 5B, which is a simplified diagram of a debris trapping device according to an exemplary embodiment.

[0342] FIG. 5B shows a debris capture device 510 comprising a frame 512 and leaves 514 or debris traps 514 or debris collecting pockets 514 .

[0343] FIG. 5B shows a mesh covering the leaf 514.

[0344] 5B shows an optional narrowing end 516 of the debris capture device 510. The narrowing end 516 allows the debris capture device 510 to be pulled into a catheter for removal from a patient's body. The narrowing end 516 can potentially pull the device 510 into the catheter and aid in compressing the device as it enters the catheter.

[0345] In some embodiments, the debris trap 514 confines the debris that it traps as the device 510 is retracted into a catheter and removed from the body along with the trapped debris.

[0346] Please refer to Figures 6A-6C, which are photographs of a debris trapping device according to an exemplary embodiment.

[0347] 6A-6C show a debris trapping device that is gradually enabled.

[0348] 6A-6C show a frame 602, a debris trap tip 604 or debris trapping leaf tip 604, a control wire guide 608, and a control wire 606 threaded through a loop in the tip 604. FIG.

[0349] FIG. 6A shows the leaf tips 604 in intimate contact with the frame 602 .

[0350] FIG. 6B shows wires 606 pulling leaf tips 604 together.

[0351] FIG. 6C shows wire 606 pulling on leaf tips 604 to completely close off the cross section of the lumen defined by frame 602.

[0352] In some embodiments, the control wire guide 608 is optionally a lumen or pipe. In some embodiments, the control wire guide 608 is optionally constructed from nitinol or a polymer.

[0353] In some embodiments, there are one or more control wire guides 608. In the exemplary embodiment shown in Figures 6A-6C, two control wire guides 608 are shown.

[0354] In some embodiments, the number of control wire guides 608 is optionally an even number, for example, 2, 4, 6, 8, etc.

[0355] In some embodiments, the number of control wire guides 608 does not necessarily have to be an even number.

[0356] When the cross section of the lumen defined by frame 602 is completely closed, all fluid flowing through the lumen must pass through the leaves. In embodiments where the leaves are covered with a mesh, all fluid flowing through the lumen must pass through the mesh.

[0357] A medical instrument can be passed through the lumen of the device. It will be apparent that a medical instrument can be passed through the lumen of the device when the leaves are tight against the frame 602 or the cross section is partially closed. Note that the wire 606 can always be slightly loosened to allow a medical instrument to pass through and slightly tightened against the medical instrument to close it off.

[0358] Reference is now made to Figures 7A-7C, which are simplified illustrations of a debris capture device positioned in an aorta, according to an exemplary embodiment.

[0359] 7A shows a debris trapping device 704 optionally having one or more levels of debris traps 706. The debris trapping device 704 is optionally located in the descending aorta 702.

[0360] FIG. 7A also shows a medical instrument 708 or catheter 708 or control wire 708 for a medical instrument passing through the debris capture device 704, with the debris capture device 704 in an activated state, i.e., with the trap open and the leaves extending toward the middle of the descending aorta.

[0361] 7A shows a debris particle 707 trapped in a debris trap 706. Once the debris trap 706 is optionally closed, the trapped debris 707 can optionally be removed from the body along with the debris trapping device 704.

[0362] 7B shows pockets 714 formed by open trap edges 710 that extend toward the center 716 of the lumen defined by the debris capture device 704. Each trap has an opening 712 that allows debris to flow down into the pocket 714.

[0363] 7C shows a debris trapping device 704 optionally having one or more levels of debris traps 706. The debris trapping device 704 is optionally located in the descending aorta 702.

[0364] Figure 7C also shows a medical instrument 708 or catheter 708 or control wire 708 for a medical instrument passing through the debris capture device 704, with the debris capture device 704 in a disabled state, i.e., with the traps closed or collapsed and the leaves tightly against the walls of the debris capture device 704.

[0365] Reference is made to FIG. 7D, which is a simplified illustration of a debris capture device positioned in an aorta, according to an exemplary embodiment.

[0366] 7D shows a debris capture device 723 that includes a frame 724, a mesh wall 725, and optionally one or more levels of debris traps 726. The debris capture device is optionally located in the descending aorta 722.

[0367] FIG. 7D also shows a medical instrument 728 or catheter 728 or control wire 728 for a medical instrument passing through the debris capture device, with the debris capture device in an enabled state, i.e., trap 726 is open and the leaves of trap 726 extend towards the centre of frame 724.

[0368] 7D also shows a particle, indicated by an "X" 729, flowing downstream along the lumen defined by frame 724. A portion of particle 729 is shown inside trap 726. Once debris trap 726 is optionally closed, the trapped debris 729 can optionally be removed from the body along with debris capture device 723.

[0369] In some embodiments, the mesh walls 725 of the debris capture device may be flexible enough that the mesh walls 725 bend inward towards the centre of the frame 724 as fluid passes through the debris capture device.

[0370] Reference is made to FIG. 7E, which is a simplified illustration of a debris capture device positioned in an aorta, according to an exemplary embodiment.

[0371] 7E shows a debris trapping device that includes a frame 744 and optionally has one or more levels of debris traps 746. The debris trapping device is optionally located in the descending aorta 742.

[0372] 7E also shows a marker 742 attached to the debris trap 746. The marker 742 is selected to be opaque to one or more imaging modalities, allowing a physician to visualize whether the trap 746 is open or closed using one of the imaging modalities.

[0373] Reference is now made to FIG. 7F, which shows a simplified diagrammatic view of an aortic protection device deployed in conjunction with a debris trapping device, according to an exemplary embodiment of the present invention.

[0374] FIG. 7F shows an aortic protection device 752 (e.g., an aortic protection device such as those described in International Patent Application Publication No. WO 2019 / 064223 to Brandeis, supra) deployed in the aorta along with a debris trapping device 754, various embodiments of which are described herein.

[0375] 7F shows a debris trapping device 754 deployed within the lumen defined by the aortic protection device 752. Various other locations for the debris trapping device 754 may be selected, including some non-limiting examples:

[0376] Not within the lumen defined by the aortic protection device 752, but upstream of the aortic protection device 752. downstream of the aortic protection device 752, rather than within the lumen defined by the aortic protection device 752. Partly within the lumen defined by the aortic protection device 752 and partly upstream of the aortic protection device 752. Partly within the lumen defined by the aortic protection device 752 and partly downstream of the aortic protection device 752.

[0377] FIG. 7F shows a cross section of the aorta extending from the proximal heart 756 to the distal heart 758, including the aortic arch.

[0378] 7F shows an aortic protection device 752 within the aorta. The aortic protection device 752 includes a mesh 760 at the aortic arch and two optional wires 762, 764 attached to the mesh 760. The mesh 760 covers the arterial outlets of the brachiocephalic artery 765, the left common carotid artery 766, and the left subclavian artery 767.

[0379] The mesh 760 may prevent debris that flows with the blood in the aorta from entering the arteries.

[0380] Note that in some embodiments, mesh 760 may optionally extend more or less than shown in Figure 7F. As a non-limiting example, mesh 760 may extend much farther in the aorta distal to the heart to cover more of the arterial outlet from the aorta.

[0381] In some embodiments, the mesh 760 optionally has controlled porosity (e.g., controlled to vary from larger to smaller pore sizes) to better protect against debris entering the side branch arteries.

[0382] In some embodiments, mesh 760 is optionally controlled to vary its porosity to completely block blood flow into the side branch artery.

[0383] In some embodiments, optionally, the mesh 760 is controlled to change its porosity for a limited period of time, for example, a few seconds (e.g., 10 seconds, 30 seconds, 60 seconds, 90 seconds) or at most a few minutes (e.g., 2 minutes, 3 minutes, 4 minutes, 5 minutes).

[0384] In some embodiments, optionally, the mesh 760 is controlled to change its porosity and completely block blood flow into the side branch artery for a limited period of time, for example, a few seconds (e.g., 10, 30, 60, 90 seconds) or at most a few minutes (e.g., 2, 3, 4, 5 minutes).

[0385] In some embodiments, the debris trapping device 754 is placed in the aorta after placing the aortic protection device 752 in the aorta. By way of non-limiting example, the aortic protection device 752 is optionally positioned and expanded first, and the debris trapping device 754 is optionally inserted into the lumen defined by the aortic protection device 752, positioned, and deployed.

[0386] In some embodiments, by way of non-limiting example, if the debris trapping device 754 is located upstream or downstream of the aortic protection device 752, the insertion order and / or location and / or deployment of the devices may be independent of each other.

[0387] In some embodiments, the aortic protection device 752 and the debris trapping device 754 are optionally operated independently of each other.

[0388] In some embodiments, the aortic protection device 752 and / or the debris trapping device 754 are optionally enabled in connection with steps performed in a medical procedure performed elsewhere in the patient's body (e.g., a medical procedure performed on a heart valve, other part of the heart, or even upstream of the left side of the heart, or upstream of the right side of the heart).

[0389] Reference is now made to Figures 7G and 7H, which show simplified diagrammatic representations of a device including combined aortic protection and debris trapping, according to an exemplary embodiment of the present invention.

[0390] 7G and 7H, which show a device 770 including a locking portion 772, a frame lumen 773, a debris trap portion 775, and an optional gradually narrowing end 776 of the device 770.

[0391] FIG. 7G is an isometric view of device 770, and FIG. 7H is a planar view of device 770.

[0392] In some embodiments, device 770 optionally includes a mesh 774 covering lumen 773. Optionally, mesh 774 acts to filter debris from entering branch arteries, as described, for example, in the aforementioned International Patent Application Publication No. WO 2019 / 064223 to Brandeis.

[0393] Reference is now made to Figures 7I and 7J, which are simplified diagrammatic illustrations of a device including a combination of aortic protection and two positions or levels of debris trapping, according to an exemplary embodiment of the present invention.

[0394] 7I and 7J, which show a device 780 including a locking / anchoring portion 782, a first debris trapping portion 783, a frame lumen 784, a second debris trapping portion 785, and an optional gradually narrowing end 786 of the device 780.

[0395] 7I is an isometric view of device 780, and FIG. 7J is a side view of device 780. FIG.

[0396] In some embodiments, device 780 optionally includes a mesh (not shown) covering frame lumen 784. Optionally, the mesh acts to filter debris from entering branch arteries, as described, for example, in the aforementioned International Patent Application Publication No. WO 2019 / 064223 to Brandeis.

[0397] In some embodiments, the first debris trapping portion 783 and the second debris trapping portion 785 optionally include a mesh for filtering the fluid and trapping debris.

[0398] In some embodiments, the first debris trapping portion 783 and the second debris trapping portion 785 optionally comprise meshes with holes of different sizes.

[0399] As a non-limiting example, in some embodiments, the pore size of the first debris trapping section 783 may optionally be 30 microns.

[0400] In some embodiments, the first debris trapping portion 783 may optionally be enabled separately from the enabling of the second debris trapping portion 785 .

[0401] In some embodiments, the first debris trapping section 783 may optionally be enabled during medical procedures known to cause a large release of debris, for example, during the pace-up and / or pace-down phases of a TAVI procedure.

[0402] As a non-limiting example, in some embodiments, the pore size of the second debris trapping section 785 may optionally be 200 microns.

[0403] In some embodiments, the second debris trapping portion 785 may optionally be enabled for a longer period of time, for example because a mesh with pores larger than 30 microns creates a smaller pressure differential and the body can tolerate such a filter for a longer period of time.

[0404] In some embodiments, the frame lumen 784 may optionally be covered with a mesh to optionally block debris exiting laterally from the frame lumen 784 .

[0405] By way of non-limiting example, in some embodiments, the pore size of the optional mesh covering the frame lumen 784 may optionally be 120 microns.

[0406] As a non-limiting example, in some embodiments, the pore size of the optional mesh covering the frame lumen 784 may optionally be between the pore size of the first debris trapping portion 783 and the pore size of the second debris trapping portion 785.

[0407] In Figures 7I and 7J, Enabling and disabling the locking or locking action of the locking / locking portion 782; Enabling and disabling the debris trap of the first debris trap portion 783; Varying the mesh size of the optional mesh covering the frame lumen 784; Enabling and disabling the debris trap of the second debris trap section 785; and Not shown are optional control wires that may be used to control one or more of pushing or pulling the optional gradually narrowing end 786 of the device 780 to place the device in place and / or remove the device.

[0408] Reference is made to FIG. 8, which is a simplified illustration of potential locations of a debris trapping device in the aorta, according to some exemplary embodiments.

[0409] FIG. 8 shows the aorta 802 and shows detailed portions of the aorta: the ascending aorta 806, the aortic arch 808, and the descending aorta 812, which includes the thoracic and abdominal aorta.

[0410] FIG. 8 also shows the location of the openings to the coronary arteries 804 and the openings to the arteries 810 leading to the brain (the brachiocephalic artery, the left common carotid artery, and the left subclavian artery).

[0411] FIG. 8 illustrates various potential locations that may be selected for placement of the debris trapping device, including a first location 816 in the ascending aorta 806, a second location 818 in the aortic arch 808, a third location 820 in the descending aorta 812, and a fourth location 822 further downstream in the thoracic or abdominal aorta.

[0412] In some embodiments, a debris trapping device is placed in the vein to prevent debris from reaching the lungs.

[0413] Reference is made to FIG. 9A, which is a simplified illustration of potential locations of a debris trapping device within a vein, according to some exemplary embodiments.

[0414] 9A shows a vena cava 902 and a debris trapping device 904 located within the vena cava 902. The vena cava 902 collects blood from the veins into the right atrium of the heart 908. The heart pumps the blood to the lungs. If debris reaches the lungs, it can be very harmful.

[0415] In some embodiments, a debris trapping device 904 is placed in the vena cava 902 to block such debris.

[0416] In some embodiments, the debris trapping device 904 traps the debris and is eventually removed from the body along with the debris.

[0417] In some embodiments, the debris trap within the debris trapping device 904 is closed to contain the trapped debris before being removed from the body along with the debris.

[0418] In some embodiments, an anticoagulant is optionally administered to disrupt and / or dissolve thrombus trapped by the device before the device is removed from the body.

[0419] Reference is made to FIG. 9B, which is a simplified diagram of a debris trapping device within a vena cava, according to an exemplary embodiment.

[0420] FIG. 9B shows the vena cava 902, the debris trapping device 912, and the control / trigger wires 914.

[0421] FIG. 9B is intended to show an exemplary embodiment that is accessed and / or controlled via femoral access.

[0422] Reference is made to FIG. 9C, which is a simplified diagram of a debris trapping device within a vena cava, according to an exemplary embodiment.

[0423] FIG. 9C shows the vena cava 902, debris trapping devices 922A, 922B, and control / trigger wires 924.

[0424] FIG. 9C is intended to illustrate an exemplary embodiment including a debris trap 922B along with a vena cava protection sheath 922A.

[0425] In some embodiments, the vena cava protection sheath 922A is made of an impermeable material to prevent bleeding from potential puncture of the vena cava itself.

[0426] FIG. 9C is also intended to illustrate an exemplary embodiment that is accessed and / or controlled via femoral access.

[0427] Please refer to FIG. 9D, which is a simplified diagram of a debris trapping device within a vena cava, according to an exemplary embodiment.

[0428] FIG. 9D shows a debris trapping device including the vena cava 902, debris trapping components 932A and 932C, a protective sheath 932B, and a control / trigger wire 934.

[0429] 9D is intended to show an exemplary embodiment including two debris traps 932A and 932C and a vena cava protection sheath 932B. In some embodiments, the two debris traps 932A and 932C are controlled separately, optionally by two control wires (not shown).

[0430] FIG. 9D is also intended to illustrate an exemplary embodiment that is accessed and / or controlled via femoral access.

[0431] Reference is made to FIG. 9E, which is a simplified diagram of a debris trapping device within a vena cava, according to an exemplary embodiment.

[0432] FIG. 9E shows the vena cava 902, the debris trapping device 942, and the control / trigger wire 944.

[0433] FIG. 9E is intended to illustrate an exemplary embodiment that is accessed and / or controlled via jugular venous access.

[0434] Reference is made to FIG. 9F, which is a simplified diagram of a debris trapping device within a vena cava, according to an exemplary embodiment.

[0435] FIG. 9F shows the vena cava 902, debris trapping devices 952A, 952B, and control / trigger wires 954.

[0436] FIG. 9F is intended to show an exemplary embodiment that includes a debris trap 952B in addition to a vena cava protection sheath 952A.

[0437] FIG. 9F is also intended to illustrate an exemplary embodiment that is accessed and / or controlled via jugular venous access.

[0438] It should be noted that devices with femoral access such as that shown in Figure 9D can be designed for jugular access, as can designs such as those shown in Figures 9E and 9F.

[0439] Please refer to Figures 9G-9J, which are simplified diagrams of debris trapping devices according to some exemplary embodiments.

[0440] 9G shows a side view (bottom) and a cross-sectional view (top) of a device 962 for trapping debris. The device 962 includes an open debris trap 964 and an expandable frame 966 for positioning the device 962, for example, in a vena cava.

[0441] Figure 9H shows a side view (bottom) and a cross-sectional view (top) of the debris trapping device 962 of Figure 9G. Figure 9H shows the debris trap 964 in a closed state.

[0442] 91 shows a side view (bottom) and a cross-sectional view (top) of a device 972 for trapping debris. The device 972 comprises an open debris trap 974 and an expandable frame 976 for positioning the device 972, for example, in a vena cava.

[0443] Figure 9J shows a side view (bottom) and a cross-sectional view (top) of the device for trapping debris 972 of Figure 91. Figure 9J shows the debris trap 974 in a closed state.

[0444] Reference is made to FIG. 9K, which shows a simplified diagram of various debris trapping devices according to some exemplary embodiments.

[0445] FIG. 9K shows an exemplary embodiment of the device positioned within a body lumen, for example, within a vena cava, with the direction of fluid flow, for example blood flow, indicated by reference numeral 9001.

[0446] Reference numeral 9002 is a simplified diagrammatic view of a debris trapping device having debris traps / leaves with tips facing upstream with respect to the fluid flow 9001 .

[0447] Reference numeral 9004 is a simplified diagrammatic view of a debris trapping device having debris traps / leaves with tips pointing downstream with respect to the fluid flow 9001 .

[0448] Reference numeral 9006 is a simplified diagram of a debris trapping device having two layers of debris traps / leaves, with a first layer having a tip facing downstream relative to the fluid flow 9001 and a second layer having a tip facing upstream relative to the fluid flow 9001.

[0449] Reference numeral 9008 is a simplified diagram of a debris trapping device having two layers of debris traps / leaves oriented with their tips in the same direction relative to the fluid flow 9001 .

[0450] Reference numeral 9010 is a simplified diagram of a debris trapping device showing that when the trap / leaves are opened, the leaves overlap.

[0451] Reference numeral 9012 is a simplified diagram of a debris trapping device intended to show leaves with different mesh hole sizes (as a non-limiting example, some leaves with a mesh hole size of 100 microns and some leaves with a mesh hole size of 250 microns).

[0452] Below are described some non-limiting examples of how the debris trapping device can be used.

[0453] Reference is now made to FIG. 10, which is a simplified flowchart of a method for collecting debris in accordance with an exemplary embodiment. Figure 10 shows Inserting (1002) a device into a body lumen for capturing debris from a fluid flow; locking the device (1004) so ​​that it is not moved downstream by fluid flow; controlling (1006) the opening of a mesh debris trap included in the device; and removing the device from the body along with the debris trapped in the debris trap (1008).

[0454] Reference is now made to FIG. 11, which is a simplified flowchart of a method for collecting debris during a cardiac procedure, according to an exemplary embodiment. Inserting a device to capture debris into a location within the aorta (1102). A medical device is inserted to perform a cardiac procedure (1104). Performing cardiac procedures (1106). The debris trapping device is removed from the body along with the debris trapped in the debris traps within the device (1108).

[0455] Reference is now made to FIG. 12, which is a simplified flowchart of a method for preventing debris from reaching the lungs, according to one example embodiment. A device for capturing debris is inserted into an intravenous location (1202). A debris trap within the device is controlled to open and collect debris from the vein (1204). Perform medical procedures (1206). A device for capturing debris is removed from the body (1208). Reference is made to FIG. 13A, which is a simplified illustration of a patient with an implanted debris trapping device, according to an exemplary embodiment. FIG. 13A shows a patient 1302 with a jugular access point 1304 from which a control wire 1306 or flexible handle 1306 exits.

[0456] In some embodiments, the control wires 1306 may optionally be attached to the shoulders or back of the patient 1302. In some embodiments, the patient 1302 may move around or even get up and walk.

[0457] FIG. 13A also shows an optional embodiment with a femoral access point 1308 .

[0458] In some embodiments, control wires (not shown) exiting the femoral access point 1308 may optionally be attached to the body of the patient 1302. In some embodiments, the patient 1302 may move around or even get up and walk.

[0459] Reference is made to FIG. 13B, which is a simplified illustration of a control handle or user interface to an implantable debris trap device, according to an exemplary embodiment.

[0460] FIG. 13B shows a control handle 1312 including an enablement handle 1316 and a control wire 1314 .

[0461] In some embodiments, the control handle 1312 may optionally include one or more optional flexible flaps 1318 for attaching and / or affixing the control handle 1312 to the patient's body.

[0462] In some embodiments, the control handle 1312 may optionally include a strap 1308 for attachment to the patient's torso, the patient's leg, or the patient's arm, as some non-limiting examples.

[0463] Reference is made to FIG. 14A, which is a simplified illustration of potential positions of a device for covering and / or sealing a venous wound, according to some exemplary embodiments.

[0464] FIG. 14A shows a vein 1402, a wound location 1408 within the vein 1402, a device 1404 positioned within the vein 1402, and an optional control and / or guide wire 1406.

[0465] In some embodiments, the device 1404 is placed within the vein 1402 to cover and / or seal a wound location 1408 within the vein 1402 .

[0466] In some embodiments, the device 1404 is optionally guided to the wound location 1408 by a control and / or guide wire 1406 .

[0467] Reference is made to FIG. 14B, which is a simplified illustration of potential positions of a device for covering and / or sealing a venous wound, according to some exemplary embodiments.

[0468] FIG. 14B shows a vein 1402, a wound location 1418 within the vein 1402, a device 1414 positioned within the vein 1402, and an optional control and / or guide wire 1416.

[0469] In some embodiments, the device 1414 is placed within the vein 1402 to cover and / or seal a wound location 1418 within the vein 1402 .

[0470] In some embodiments, the device 1414 is optionally guided to the wound location 1418 by a control and / or guide wire 1416 .

[0471] Reference is made to FIG. 14C, which is a simplified illustration of a device for covering and / or sealing a venous wound, according to some exemplary embodiments.

[0472] FIG. 14C shows a cross-sectional view of a device 1422 that can be collapsed into an introducer catheter and expanded to cover and / or seal the surface of a vein.

[0473] In some embodiments, if the circumference of the vein is smaller than the circumference of the device 1422, the device can optionally expand to cover the wound in the vein and remain partially overlapping, as shown in FIG. 14C.

[0474] In some embodiments, if the circumference of the vein is approximately equal to the circumference of the device 1422, the device may optionally be expanded to cover the entire circumference of the vein (not shown).

[0475] In some embodiments, if the circumference of the vein is greater than the circumference of device 1422, the device may optionally be expanded (not shown) to cover only a portion of the circumference of the vein. However, if the wound does not extend the entire circumference of the vein, the device may still cover and / or seal the entire area of ​​the wound.

[0476] Reference is made to FIG. 14D, which is a simplified illustration of a device for covering and / or sealing a venous wound, according to some exemplary embodiments.

[0477] 14D shows a cross-sectional view of a device 1424 that can be folded into an introducer catheter and expanded to cover and / or seal the surface of a vein. As shown in FIG. 14D, the device 1424 optionally includes a film, fabric, or mesh connecting the ends of the device 1424.

[0478] In some embodiments, if the circumference of the vein is smaller than the circumference of the device 1424, the device can optionally expand to cover the wound in the vein and remain partially overlapping, as shown in FIG. 14D.

[0479] In some embodiments, if the circumference of the vein is approximately equal to the circumference of the device 1424, the device may optionally be expanded to cover the entire circumference of the vein (not shown).

[0480] In some embodiments, if the circumference of the vein is greater than the circumference of the device 1424, the film or cloth or mesh connecting the ends of the device 1424 can potentially cover the gap between the ends of the body of the device 1424, allowing the device to cover and / or seal the entire area of ​​the wound.

[0481] Reference is now made to FIG. 15, which is a simplified illustration of ejecting debris from a device for trapping debris, according to some exemplary embodiments.

[0482] Figure 15 shows a vena cava 1502 in which a device 1504 for trapping blood-borne material is positioned, according to certain exemplary embodiments described herein. In Figure 15, the direction of blood flow is toward the top of the figure. The device 1504 includes a debris trap 1506.

[0483] In some embodiments, a physician can insert a tube 1520 and optionally apply suction 1518 through the tube 1520 to suck debris 1508 , 1510 out of the trap 1506 .

[0484] In some embodiments, the wire 1518 can pass through the tube 1520, with an optional snare 1514 for grasping the hook 1512 or guide 1512. This allows the tube 1520 to be guided into the trap 1508 of the device 1504.

[0485] In some embodiments, the tube 1520 may optionally be the same catheter that delivered the debris trapping device 1504 .

[0486] Reference is made to Figures 16A-16E, which are simplified illustrations of various debris traps according to some exemplary embodiments.

[0487] 16A shows a device 1604 for trapping debris located within a vena cava 1602. The device 1604 shows debris traps 1606 in the form of multiple pouches or multiple pockets.

[0488] 16B shows a device 1614 for trapping debris located in the vena cava 1612. The device 1614 shows a debris trap 1616 in the form of multiple pouches or pockets, each pouch or pocket having a different length.

[0489] 16C shows a device 1624 for trapping debris located in the vena cava 1622. The device 1624 shows a debris trap 1626 in the form of a spiral mesh in the blood flow path. The mesh is capable of trapping debris carried by the blood. In some embodiments, the mesh pore size of the spiral mesh optionally varies along the blood flow path or along the axial direction of the lumen of the device 1624. In some embodiments, the pore size of the mesh decreases along the blood flow path or along the axial direction of the lumen of the device 1624, with larger pore sizes upstream and smaller pore sizes downstream.

[0490] 16D shows a device 1634 for trapping debris located in the vena cava 1632. The device 1634 shows debris traps 1636 in the form of multiple levels of pouches or pockets along the blood flow path or axially along the lumen of the device 1634.

[0491] Figure 16E shows a device 1644 for trapping debris located within the vena cava 1642. Figure 16E shows debris being trapped, potentially large debris or large thrombi, in at least one debris trap 1646. The debris trap 1646 traps the debris and prevents it from flowing downstream, but leaves a portion of the lumen of the device 1644 open to allow blood to pass through the device 1644 and continue to be filtered within the device 1644.

[0492] It is expected that many related types of meshes will be developed during the life of the patent that matures from this application, and the scope of the term mesh is intended to pre-emptively include all such new technologies.

[0493] The terms "comprising," "including," "having," and conjugations thereof mean "including but not limited to."

[0494] The term "consisting of" means "including and limited to."

[0495] 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.

[0496] 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.

[0497] 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.

[0498] "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.

[0499] 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.

[0500] 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.

[0501] 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.

[0502] 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.

[0503] 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.

[0504] 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.

[0505] 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. 1. A device for capturing debris from a blood flow in a blood vessel, comprising: an expandable frame having a shape and size to expand against the wall of a blood vessel; a debris arrester attached to the frame; a control wire attached to the debris blocking portion and configured to control the opening of the debris blocking portion; The device, wherein the control wire extends upstream from the debris arresting portion relative to the direction of blood flow within the blood vessel.

2. The blood vessel is a vena cava. The device of claim 1 .

3. The debris blocking portion comprises a mesh having holes of a size that allows blood to pass through but does not allow debris of a certain size or larger to pass through.

3. A device according to claim 1 or 2.

4. the debris arrestor comprises one or more mesh debris traps; A device according to any one of claims 1 to 3.

5. The debris blocking section is arranged to be opened and closed by the control wire from outside the patient's body. A device according to any one of claims 1 to 4.

6. At least some of the mesh debris traps are arranged to be opened and closed separately from at least some other mesh debris traps. The device of claim 4.

7. a plurality of control wires, each configured to control a separate group of said mesh debris traps; 7. A device according to claim 4 or 6.

8. the mesh debris trap remains in a normally closed position even when the device is expanded against the wall of the body lumen; 8. A device according to any one of claims 4, 6 and 7.

9. the mesh debris trap is configured to allow passage of a medical instrument through a tubular lumen defined by the interior of the device when the device is expanded against the wall of the vena cava. A device according to any one of claims 4 and 6 to 8.

10. the mesh debris trap comprises a mesh leaf having a base attached to a frame wall and a rim located upstream of the base of the mesh leaf; A device according to any one of claims 4 and 6 to 9.

11. the mesh debris trap comprises a mesh leaf having a base attached to a frame wall and a rim located downstream of the base of the mesh leaf; A device according to any one of claims 4 and 6 to 9.

12. the mesh debris trap is positioned such that mesh debris trap openings are distributed at different distances along the direction of blood flow through the device; A device according to any one of claims 4 and 6 to 11.

13. at least some of the levels of the mesh debris trap are arranged to be closed separately from at least some other levels of the mesh debris trap; The device of claim 12.

14. the mesh debris trap comprises a mesh having a pore size ranging from 3000 microns to 2000 microns to 1000 microns to 30 microns; The device of claim 12.

15. the mesh debris trap openings distributed at different distances along the blood flow direction include mesh pore openings of different sizes; A device according to any one of claims 12 to 14.

16. the mesh debris traps are oriented longitudinally along the device such that, when open, the openings of the opened mesh debris traps overlap when viewed along the direction of blood flow. A device according to any one of claims 12 to 14.

17. the different sized mesh pore openings are arranged such that larger pore sizes are upstream of smaller pore sizes; 16. The device of claim 15.

18. With at least three levels of mesh hole size: 1000 microns, 400 microns, and 200 microns; 18. The device of claim 17.

19. the mesh debris trap openings at the same distance along the blood flow direction include mesh pore openings of different sizes; A device according to any one of claims 1 to 18.

20. when a plurality of the mesh debris traps are open, the open mesh debris traps cover an entire cross-sectional area transverse to the direction of blood flow of a lumen defined by the expandable frame. A device according to any one of claims 4 and 6 to 18.

21. a mesh debris trap opening configured to conform to a lumen wall when the mesh debris trap is not open; A device according to any one of claims 1 to 20.

22. The mesh debris trap is configured as overlapping leaves; A device according to any one of claims 1 to 21.

23. the mesh debris trap comprises a filtering mesh; A device according to any one of claims 1 to 22.

24. a mesh debris trap that allows passage of a medical instrument along the device and abuts against the medical instrument to block passage of debris; A device according to any one of claims 1 to 23.

25. the mesh debris trap opening comprises a loop for passing a control wire to open said mesh debris trap; A device according to any one of claims 1 to 21.

26. the mesh debris trap opening is flexible to allow a surgical instrument to bend through the mesh debris trap opening and pass along the device; A device according to any one of claims 1 to 25.

27. Expansion of the frame against the wall of the vena cava anchors the device and resists migration in the direction of blood flow. A device according to any one of claims 1 to 20.

28. The device is anchored to resist movement in the direction of blood flow by being connected to an anchoring frame that is extended against the lumen wall upstream of the device. A device according to any one of claims 1 to 27.

29. The device is anchored to resist migration in the direction of blood flow by being connected to an anchor wire that extends outside the patient's body. A device according to any one of claims 1 to 28.

30. 1. A method for collecting debris, comprising: inserting a device into the vena cava to capture debris from the fluid flow; locking the device from being moved downstream by the fluid flow; controlling the opening of a mesh debris trap included in the device; and removing the device from the body along with the debris trapped in the debris trap.

31. the inserting includes inserting via jugular vein access.

31. The method of claim 30.

32. the inserting includes inserting via femoral access.

31. The method of claim 30.

33. said anchoring including anchoring downstream of an expected source of said debris; 31. The method of claim 30.

34. further comprising inserting an instrument along the device and upstream of the device to perform a medical procedure.

34. The method of claim 33.

35. performing the medical procedure after opening the mesh debris trap.

34. The method of claim 33.

36. The device is used in addition to the use of an aortic protection device.

36. The method according to any one of claims 32 to 35.

37. The method is performed on a patient with a condition that is expected to release or generate debris into the veins, 34. The method according to any one of claims 30 to 33.

38. further comprising closing the mesh debris trap before removing the device from the body.

38. The method according to any one of claims 30 to 37.

39. opening the mesh debris traps includes controlling only a subgroup of the mesh debris traps; 39. The method according to any one of claims 30 to 38.

40. 1. A method of collecting debris during a medical procedure, comprising: inserting a device for capturing debris at a location within the vena cava; inserting a medical instrument to perform the medical procedure; performing the medical procedure; removing the device for trapping debris from the body along with the debris trapped in a debris trap within the device; A method comprising:

41. further including identifying patients who may need protection from debris; 41. The method of claim 40.

42. the identifying is based on a condition of the patient.

42. The method of claim 41.

43. the debris trap within the device is controlled to close prior to the removing; 43. The method according to any one of claims 40 to 42.

44. The debris trap within the device is controlled to be released prior to performing the medical procedure.

44. The method according to any one of claims 40 to 43.

45. The medical procedure comprises: vena cava repair, vena cava / venous stent placement, Pulmonary embolism (PE) removal, Right heart medical procedures, pulmonary nerve blockade, Electrophysiological procedures, and Patent Foramen Ovale (PFO) treatment, a medical procedure selected from the group consisting of 45. The method according to any one of claims 40 to 44.

46. 1. A method for preventing debris from reaching the lungs, comprising: inserting a device into an intravenous location to capture debris; controlling a debris trap in the device to open and collect debris from the vein; Carrying out medical procedures; removing the debris capturing device from the body; A method comprising:

47. Prior to removing the device, the debris trap is controlled to be closed.

47. The method of claim 46.

48. The removing includes removing together with debris trapped in a debris trap within the device.

48. The method of claim 46 or 47.

49. further comprising administering an anticoagulant prior to said removing.

49. The method according to any one of claims 46 to 48.

50. The debris trap within the device comprises: kidney procedures, aneurysm procedures, damage, open lesions, Disconnection, Damage in disaster situations, traumatic injuries, blunt trauma injuries, medical procedures, including cardiac support; medical procedures, including pulmonary support; medical procedures, including extracorporeal membrane oxygenation (ECMO); Open surgery, and Pressure damage, controlled to be released after or during treatment selected from the group consisting of 50. The method of any one of claims 46 to 49.

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