Magnetic rotor devices, systems, and methods

Abstract

Disclosed herein are catheters, systems, and methods for breaking down and / or clearing an occlusion in a blood vessel, vein, artery, or cavity. The system can include a catheter having a rotary magnetic tip, and an external magnet operable to generate a magnetic field.

Description

PATENTAttorney Docket No. 104954-835903Via Patent CenterMAGNETIC ROTOR DEVICES, SYSTEMS, AND METHODSCross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 685,119, filed August 20, 2024, the contents of which are entirely incorporated by reference herein.Field of Disclosure

[0002] The present disclosure relates to devices, systems, and methods for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity. The system can include a catheter and an external magnet. The catheter can include a rotary magnetic tip operable to be rotated by a magnetic field generated by the external magnet.Background

[0003] Cardiovascular disease is a leading cause of death in the United States, with coronary heart disease and myocardial infarction resulting in nearly 400,000 deaths in the United States each year. For over 30 years, rotational and orbital atherectomy have been successful in enabling stent deliverability in severely calcified coronary lesions. However, the unique capabilities of these valuable tools have not evolved due to fundamental mechanical limitations, which include obtaining access to tortuous vasculature, adverse heating, arterial perforation, and generation of embolic debris.

[0004] Inaccessible blood clots within small distal neurovascular arteries often result in poorer acute ischemic stroke patient outcomes. In addition to forming naturally, small emboli are often a consequence of thrombectomy-generated debris.

[0005] Therefore, there is a need for a system operable to break down and / or clear occlusions in arteries, veins, blood vessel, and cavities not only within the heart and brain, but also in other areas of the human body.Summary105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0006] Provided herein is a catheter for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity. The catheter can include a catheter body defining a longitudinal axis; at least one lumen contained within the catheter body; a mounting mechanism attached to the catheter body; and a magnetic tip rotatably coupled to the mounting mechanism. The magnetic tip can be operable to rotate about the longitudinal axis in response to a magnetic field being applied to the magnetic tip.

[0007] In some aspects, the magnetic tip can include an abrasive surface operable to grind the occlusion. In some aspects, the abrasive surface can include a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating. In some aspects, the at least one lumen can include a guidewire lumen operable to receive a guidewire, an aspiration lumen operable to receive fluid proximal to the occlusion, and / or a fluid delivery lumen operable to deliver fluid to the occlusion.

[0008] In some aspects, rotation of the magnetic tip can be operable to generate a vacuum force operable to cause fluid to be drawn into the aspiration lumen. In some aspects, rotation of the magnetic tip can be operable to mix fluid delivered to the occlusion via the fluid delivery lumen. In some aspects, the mounting mechanism can include a spindle, a slip joint, or a ball joint.

[0009] Further provided herein is a system for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity. The system can include a catheter and an external magnet operable to generate a magnetic field. The catheter can include a catheter body defining a longitudinal axis, at least one lumen contained within the catheter body, a mounting mechanism attached to the catheter body, and a magnetic tip rotatably coupled to the mounting mechanism. The magnetic field can be operable to cause the magnetic tip to rotate about the longitudinal axis.

[0010] In some aspects, the magnetic tip can include an abrasive surface operable to grind the occlusion. In some aspects, the abrasive surface can include a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating. In some aspects, the at least one lumen can include a guidewire lumen operable to receive a guidewire, an aspiration lumen operable to2105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center receive fluid proximal to the occlusion, and a fluid delivery lumen operable to deliver fluid to the occlusion. In some aspects, rotation of the magnetic tip can be operable to generate a vacuum force operable to cause fluid to be drawn into the aspiration lumen.

[0011] In some aspects, rotation of the magnetic tip can be operable to mix fluid delivered to the occlusion via the fluid delivery lumen. In some aspects, the mounting mechanism can include a spindle, a slip joint, or a ball joint.

[0012] Further provided herein is a method for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity. The method can include navigating a catheter including a rotatable magnetic tip to the occlusion, providing, via an external magnet, a magnetic field operable to rotate the rotatable magnetic tip, breaking down and / or clearing the occlusion by grinding the occlusion with the rotatable magnetic tip.

[0013] In some aspects, navigating the catheter can include receiving a guidewire through at least one lumen of the catheter and steering the catheter along the guidewire to the occlusion. In some aspects, the method can further include providing, via a fluid delivery lumen of the catheter, a fluid to the occlusion. In some aspects, the rotatable magnetic tip can include an abrasive surface. In some aspects, the abrasive surface can include a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating. In some aspects, rotation of rotatable magnetic tip stirs the fluid.

[0014] Further provided herein is a system for breaking down or clearing an occlusion. The system can include a catheter and an external magnet operable to generate a magnetic field. The catheter can include a catheter body including at least one lumen defining an axis, a spindle attached to the catheter body, and a magnetic tip rotatably mounted to the spindle.

[0015] In some aspects, at least a portion of the magnetic tip can have an abrasive surface. In some aspects, the abrasive surface can include an abrasive coating. In some aspects, the abrasive coating can include a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating. In some aspects, the bonded powdered coating can include platinum, gold, silica, or other3105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center metals. In some aspects, the abrasive surface can include an etched, knurled, and / or stippled surface. In some aspects, the abrasive surface can be a micropatterned surface operable to improve emboli dissolution.

[0016] In some aspects, the system can further include a guidewire operable to guide the catheter. The guidewire can be contained within the at least one lumen. In some aspects, the magnetic field can be operable to control a movement of the guidewire. In some aspects, the guidewire can include a magnetic material. In some aspects, the magnetic material can include PtCo and / or NdBFe. In some aspects, the magnetic material can increase a total magnetic mass of the catheter, thereby improving a maximum degree of deflection of the catheter and / or decreasing a strength of the magnetic field necessary to deflect the catheter.

[0017] In some aspects, the magnetic field can be operable to selectively rotate the magnetic tip and / or selectively control a movement of the catheter. In some aspects, the magnetic field can be operable to cause the magnetic tip to rotate about the axis at a rotation rate of about 60 rpm to about 2,000 rpm. In some aspects, the rotation rate can be about 200 rpm to about 2,000 rpm. In some aspects, the rotation rate can be about 1 ,000 rpm to about 2,000 rpm. In some aspects, the rotation rate can be about 200 rpm to about 500 rpm. In some aspects, the rotation rate can be about 1 ,200 rpm. In some aspects, rotation of the magnetic tip can stabilize at the rotation rate.

[0018] In some aspects, the magnetic field can be operable to steer the magnetic tip within the artery, cavity, vein, or blood vessel, thereby steering the catheter. In some aspects, the system can further include a fluid source operable to provide a fluid to the at least one lumen. In some aspects, the fluid can include one or more drugs, x-ray contrast agents, Von Willebrand factor, acids, neuroprotectants, DNAse, other therapeutic agents, and other diagnostic agents. In some aspects, the one or more drugs can include a thrombolytic. In some aspects, the thrombolytic can include alteplase, Tenecteplase, urokinase, desmoteplase, reteplase, and / or streptokinase.

[0019] In some aspects, the fluid source can provide a pressurized fluid through the at least one lumen, wherein the pressurized fluid rotates the magnetic tip. In some aspects, the at least one lumen can include a guidewire lumen, an aspiration lumen, and4105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center a fluid delivery lumen. In some aspects, the guidewire lumen, the aspiration lumen, and the fluid delivery lumen can be concentric lumens. In some aspects, the guidewire lumen, the aspiration lumen, and the fluid delivery lumen can be side-by-side lumens. In some aspects, the aspiration lumen can be operable to provide a vacuum force. In some aspects, the vacuum force can cause the magnetic tip to rotate.

[0020] In some aspects, the magnetic tip can be a distal magnetic bur. In some aspects, the magnetic tip can include one or more fluid delivery ports. In some aspects, the one or more fluid delivery ports can include a distal fluid delivery port at a tip of the magnetic tip. In some aspects, the one or more fluid delivery ports can include one or more side delivery ports disposed on a circumferential surface of the magnetic tip. In some aspects, the magnetic tip can include one or more aspiration ports.

[0021] In some aspects, the one or more aspiration ports can include a distal aspiration port at a tip of the magnetic tip and / or one or more side aspiration ports disposed on a circumferential surface of the magnetic tip. In some aspects, a rotation of the magnetic tip can be operable to provide a vacuum pressure, thereby causing fluids to be vacuumed into the at least one lumen.

[0022] In some aspects, the system can further include a 3D localization subsystem. In some aspects, the 3D localization system can include a robotic arm. In some aspects, the 3D localization subsystem can be a magnetic 3D localization system. In some aspects, the 3D localization subsystem can use AC and / or DC fields. In some aspects, the magnetic 3D localization subsystem can be operable to locate the magnetic tip within 1 mm. In some aspects, the magnetic 3D localization subsystem includes a localization pad. In some aspects, the localization pad can be radiotranslucent. In some aspects, the localization pad can be operable to be installed under a patient table. In some aspects, the magnetic 3D localization subsystem can generate a localization field over an occlusion site and surrounding blood vessels, cavities, arteries, and veins of a patient. In some aspects, the magnetic 3D localization subsystem further can include one or more localization coils. In some aspects, the localization pad and the one or more localization coils can be compatible with the magnetic tip and the external magnet. In5105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center some aspects, the one or more localization coils can have a diameter of less than about 0.3 mm.

[0023] In some aspects, the magnetic 3D localization subsystem can be operable to update a position of the magnetic tip in real-time within an accuracy threshold of about 1 mm. In some aspects, the magnetic 3D localization subsystem is not affected by biological impendence or susceptibility. In some aspects, the catheter can further include one or more 3D localization sensors. In some aspects, the one or more 3D localization sensors can have at least five degrees of freedom. In some aspects, the one or more 3D localization sensors can be operable to provide a real-time angulation and / or a real-time position of the magnetic tip.

[0024] In some aspects, the magnetic tip can have a shape operable to break down a clot. In some aspects, the magnetic tip can include helical grooves. In some aspects, the magnetic tip can include one or more wings. In some aspects, the one or more wings can be evenly spaced. In some aspects, the magnetic tip can include a dome shape, a prolate shape, a cylindrical shape, a spherical shape, a cube shape, a cuboid shape, or a triangular prism shape. In some aspects, the dome shape can increase in diameter from a distal end furthest from the catheter body to a proximal end. In some aspects, the dome shape can increase in diameter from the proximal end to the distal end.

[0025] In some aspects, the magnetic tip can include one or more cutting edges. In some aspects, the one or more cutting edges can be disposed on a distal tip of the magnetic tip and / or a circumferential surface of the magnetic tip. In some aspects, the magnetic tip can have one or more teeth on a distal end furthest from the catheter body. In some aspects, the magnetic tip can have one or more teeth on a circumferential surface of the magnetic tip. In some aspects, the magnetic tip can be operable to mix a fluid as it rotates. In some aspects, the magnetic tip can mix the fluid outside of the magnetic tip and / or the fluid contained within the magnetic tip.

[0026] In some aspects, an applied torque on the magnetic tip can correspond to a distance between the magnetic tip and the external magnet. In some aspects, a rotation speed of the magnetic tip can correspond to a rotation speed of the external magnet. In some aspects, the magnetic tip can have a diameter of about 1 mm to about 5 mm or6105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center about 2 mm to about 3 mm. In some aspects, the magnetic tip can include PtCo, SmCo, NdBFe, and / or bonded magnets. In some aspects, the artery, vein, cavity, or blood vessel can be located in an arm, leg, brain, heart, neck, torso, or any body part of a patient. In some aspects, the system can be used for atherectomies and / or thrombectomies.

[0027] In some aspects, the magnetic field can be 50 mT or less. In some aspects, the magnetic field can be 30 mT or less. In some aspects, a tip of the magnetic tip can include a radiopaque material and a body of the magnetic tip includes a radiotranslucent material. In some aspects, one or more proximal connectors can include the radiopaque material. In some aspects, a fixed distance can be maintained between the tip and the one or more proximal connectors. In some aspects, the system can further include an X- ray machine operable to locate the radiopaque material when the catheter is in use.

[0028] In some aspects, a circumferential surface of the magnetic tip can include an angled ribbon of radiopaque material. In some aspects, at least a portion of the magnetic tip can include a radiopaque material. In some aspects, the radiopaque material can allow visualization of a rotation of the magnetic tip under a fluoroscope and / or another imaging system. In some aspects, the magnetic field can provide an off-axis magnetic force to the magnetic tip, thereby causing an orbital motion and / or an erratic motion. The orbital motion and / or erratic motion can be operable to breakdown or debulk a larger volume of the occlusion as compared to a non-orbital device.

[0029] In some aspects, the orbital motion and / or the erratic motion can promote stirring of a fluid within the catheter or outside of the catheter. In some aspects, the magnetic tip can have a tip comprising a rough surface. In some aspects, the external magnet can be cylindrical, octagonal, or another shape. In some aspects, the external magnet can include a high energy material. In some aspects, the high energy material can be NdBFe. In some aspects, the external magnet can have a mass of about 10 kg to about 30 kg. In some aspects, the external magnet can be operable to be positioned in three dimensions around a patient. In some aspects, the system can further include an external magnet assembly, the external magnet assembly comprising a robotic arm coupled to the external magnet, the robotic arm configured to position the external magnet with respect to the catheter.7105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0030] In some aspects, the external magnet can include an electromagnet operable to generate temporal magnetic fields. In some aspects, the magnetic tip can have a selective surface. In some aspects, the selective surface can be configured to convey fluids and / or shear the occlusion. In some aspects, the catheter can further include a speed sensor disposed on or near the spindle and / or the magnetic tip. The speed sensor can be configured to measure a rotation speed of the magnetic tip.

[0031] Further provided herein is a method for breaking down or clearing an occlusion in an artery, blood vessel, vein, or cavity. The method can include navigating a catheter including a rotatable magnetic tip to the occlusion, providing, via an external magnet, a magnetic field operable to rotate the rotatable magnetic tip, and breaking down and / or clearing the occlusion by grinding the occlusion with the rotatable magnetic tip.

[0032] In some aspects, navigating the catheter can include receiving a guidewire through at least one lumen of the catheter and steering the catheter along the guidewire. In some aspects, the method can further include providing one or more diagnostic and / or therapeutic agents to the occlusion via a fluid delivery lumen of the catheter. In some aspects, the method can further include providing aspiration to an occlusion site of the occlusion by providing a vacuum pressure through an aspiration lumen of the catheter. In some aspects, the method can further include locating a position and / or angulation of the catheter in real-time.

[0033] Further provided herein is a system for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity. The system can include a catheter and an external magnet operable to generate a magnetic field. The catheter can include a catheter body including at least one lumen defining an axis, a spindle attached to the catheter body, and a magnetic rotor rotatably mounted to the spindle.

[0034] In some aspects, the magnetic rotor can be a magnetic tip. In some aspects, the magnetic rotor can include a distal tip. In some aspects, the distal tip can include a cap configured to breakdown and / or debulk the occlusion. In some aspects, the magnetic rotor can include a bit to breakdown and / or debulk the occlusion.

[0035] Further provided herein is a catheter for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity. The catheter can include a catheter8105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center body and a magnetic tip assembly. The catheter body can include at least one lumen defining an axis and a ball joint connector. The magnetic tip assembly can include a magnetic tip holder and a magnetic tip. The magnetic tip holder can include a ball operable to be received within the ball joint connector. The magnetic tip can be coupled to the magnetic tip holder. Movement of the magnetic tip can be controlled by an external magnetic field.

[0036] In some aspects, the at least one lumen includes an inner lumen that extends through the magnetic tip assembly to a distal end of the magnetic tip. In some aspects, the at least one lumen can further include a localization sensor lumen. In some aspects, the catheter can further include a localization sensor contained within the localization sensor lumen.

[0037] Further provided herein is a catheter for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity. The catheter can include a catheter body having a longitudinal axis and a magnetic tip rotatable coupled to the catheter body. The magnetic tip can be operable to rotate about the longitudinal axis.

[0038] In some aspects, the magnetic tip can rotate about the longitudinal axis when supplied an external magnetic field. In some aspects, the magnetic tip can include a shape and / or surface configured to grind the occlusion. In some aspects, the surface can include an abrasive surface. In some aspects, the shape and / or the surface can be configured to breakdown the occlusion without the use of a thrombolytic and / or other therapeutic agent. In some aspects, the magnetic tip can be configured to capture the occlusion. In some aspects, the magnetic tip can be operable to rotate the captured occlusion. In some aspects, the catheter can further include a fluid delivery lumen operable to deliver a thrombolytic and / or other therapeutic agent. In some aspects, the thrombolytic and / or other therapeutic agent can break down the occlusion as the occlusion is rotated by the magnetic tip.

[0039] In some aspects, the magnetic tip can include a net. In some aspects, the catheter can further include at least one lumen. In some aspects, the at least one lumen can be operable to receive a guidewire, deliver a fluid to the occlusion, and / or aspirate an occlusion site including the occlusion and / or a surrounding area. In some aspects, the at9105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center least one lumen can include a single lumen operable to receive a guidewire, deliver a fluid to the occlusion, and / or aspirate an occlusion site including the occlusion and / or a surrounding area. In some aspects, the at least one lumen can include a fluid delivery lumen, an aspiration lumen, and a guidewire lumen.

[0040] Other aspects and iterations of the invention are described more thoroughly below.Brief Description of Figures

[0041] The description will be more fully understood with reference to the following figures and graphs, which are presented as various embodiments of the disclosure and should not be construed as a complete recitation of the scope of the disclosure. It is noted that, for purposes of illustrative clarity, certain elements in various drawings may not be drawn to scale. Understanding that these drawings depict only exemplary embodiments of the disclosure and are not therefore to be considered limiting of its scope, the principles herein are described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0042] FIG. 1 illustrates a catheter in one example.

[0043] FIG. 2 illustrates a catheter in one example.

[0044] FIG. 3 illustrates a magnetic tip of a catheter in one example.

[0045] FIG. 4 illustrates a magnetic tip of a catheter in one example.

[0046] FIG. 5 illustrates a magnetic tip of a catheter in one example.

[0047] FIG. 6 illustrates a magnetic tip of a catheter in one example.

[0048] FIG. 7A illustrates a magnetic tip in one example.

[0049] FIG. 7B illustrates a magnetic tip in one example.

[0050] FIG. 7C illustrates a magnetic tip in one example.

[0051] FIG. 8A illustrates an external magnet in one example.

[0052] FIG. 8B illustrates an external magnet system in one example.

[0053] FIG. 8C illustrates an external magnet system in one example.

[0054] FIG. 9 illustrates a graph illustrating magnetic field strength as a function of distance from a side and front of an external magnet in one example. io105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0055] FIG. 10A illustrates a motion of a magnetic tip at two rotation rates.

[0056] FIG. 10B is a graph of magnetic tip angle stability as a function of rotational speed.

[0057] FIG. 11 A illustrates an experimental set up for debris.

[0058] FIG. 11 B illustrates an experimental set up for grinding force.

[0059] FIG. 11 C illustrates an experimental set up for temperature evaluation.

[0060] FIG. 11 D illustrates cardiac phantom with tortuosity and bifurcations.

[0061] FIG. 11 E illustrates successful tortuous navigation.

[0062] FIG. 12 illustrates a magnet system, a heart volume, and an X-ray.

[0063] FIG. 13 illustrates a lesion phantom.

[0064] FIG. 14 illustrates a stagnant column diverting dye (throm bo-lytic surrogate) back into flow.

[0065] FIG. 15A illustrates a 1 mm magnetic tip.

[0066] FIG. 15B illustrates a magnetic guidewire accessing three distal vein segments.

[0067] FIG. 16 illustrates a method for breaking down and / or clearing an occlusion in one example.

[0068] FIG. 17 illustrates a catheter in one example.

[0069] FIG. 18 illustrates a catheter in one example.

[0070] FIG. 19 illustrates a catheter in one example.

[0071] FIG. 20 illustrates a catheter in one example.

[0072] FIG. 21 A illustrates a catheter in one example.

[0073] FIG. 21 B illustrates a catheter in one example.

[0074] FIG. 21 C illustrates a catheter in one example.

[0075] FIG. 22 illustrates an external magnet system in one example.

[0076] FIG. 23A illustrates a catheter in one example.

[0077] FIG. 23B illustrates a catheter in one example.

[0078] FIG. 23C illustrates a cross-section of a catheter in one example.

[0079] FIG. 23D illustrates an exploded view of a catheter in one example.

[0080] FIG. 23E illustrates a cross-section of a catheter in one example.11105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0081] FIG. 23F illustrates a cross-section of a catheter in one example.

[0082] FIG. 23G illustrates a catheter in one example.

[0083] FIG. 23H illustrates a cross-section of a catheter in one example.

[0084] FIG. 23I illustrates a catheter in one example.

[0085] FIG. 23J illustrates a cross-section of a catheter in one example.

[0086] FIG. 23K illustrates a cross-section of a catheter in one example.

[0087] FIG. 23L illustrates a catheter in one example.

[0088] FIG. 23M is a perspective view of a cap for a magnetic tip in one example.

[0089] FIG. 23N is a front view of a cap for a magnetic tip in one example.

[0090] FIG. 230 is a cross-section of a cap taken along line A-A of FIG. 23N.

[0091] FIG. 23P is a side view of a cap for a magnetic tip in one example.

[0092] FIG. 23Q is a top view of a magnetic tip connector in one example.

[0093] FIG. 23R is a side view of a magnetic tip connector in one example.

[0094] FIG. 23S is a side view of a magnetic tip connector in one example.

[0095] FIG. 23T is a rear view of a magnetic tip connector in one example.

[0096] FIG. 23U is a front view of a magnetic tip connector in one example.

[0097] FIG. 23V is a perspective view of a magnetic tip connector in one example.

[0098] FIG. 23W is a top view of a magnetic tip connector in one example.

[0099] FIG. 23X is a side view of a magnetic tip connector in one example.

[0100] FIG. 23Y is a side view of a magnetic tip connector in one example.

[0101] FIG. 24A is a rear view of a magnetic tip connector in one example.

[0102] FIG. 24B is a front view of a magnetic tip connector in one example.

[0103] FIG. 24C is a perspective view of a magnetic tip connector in one example.

[0104] FIG. 24D is a magnetic tip holder in one example.

[0105] FIG. 24E is a cross section of a magnetic tip holder taken across line A-A of FIG. 24D.

[0106] FIG. 24F is a perspective view of a magnetic tip holder.

[0107] FIG. 24G is a front view of a magnetic tip holder.

[0108] Reference characters indicate corresponding elements among the views of the drawings. The headings used in the figures do not limit the scope of the claims.12105119194.4PATENTAttorney Docket No. 104954-835903Via Patent CenterDetailed Description

[0109] Various embodiments of the disclosure are discussed in detail below. While specific implementations are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations may be used without parting from the spirit and scope of the disclosure. Thus, the following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description. References to one or an embodiment in the present disclosure can be references to the same embodiment or any embodiment; and such references mean at least one of the embodiments.

[0110] Reference to “one embodiment”, “an embodiment”, or “an aspect” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” or “in one aspect” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others.

[0111] The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Alternative language and synonyms may be used for any one or more of the terms discussed herein, and no special significance should be placed upon whether or not a term is elaborated or discussed herein. In some cases, synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only and is not intended to further limit the scope and meaning of the disclosure or of any example term. Likewise, the disclosure is not limited to various embodiments given in this specification.13105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0112] As used herein, “about” refers to numeric values, including whole numbers, fractions, percentages, etc., whether or not explicitly indicated. The term “about” generally refers to a range of numerical values, for instance, ± 0.5-1 %, ± 1 -5% or ± 5-10% of the recited value, that one would consider equivalent to the recited value, for example, having the same function or result.

[0113] As used herein, “distal” refers to a component, or portion thereof, closest to an occlusion to be treated. “Proximal” refers to a component, or portion thereof, furthest away from the occlusion.

[0114] Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or can be learned by practice of the herein disclosed principles. The features and advantages of the disclosure can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the disclosure will become more fully apparent from the following description and appended claims or can be learned by the practice of the principles set forth herein.

[0115] Cardiovascular disease (CVD) is the leading cause of mortality in the United States (US), resulting in 850,000 annual deaths, of which nearly 400,000 are associated with coronary heart disease (CHD) and myocardial infarction (Ml). By 2030, global annual deaths will exceed 20 million. More than 90 million US adults currently live with CVD, which is associated with an annual economic burden of more than $330 billion. Together, Ml and CHD are the most expensive conditions treated in US hospitals, totaling more than $20 billion each year, with costs expected to double by 2030. Percutaneous coronary intervention (PCI) is an effective strategy to restore blood flow for obstructive CHD. However, while nearly 950,000 PCI procedures are performed each year in the US, navigating tortuous vessels is challenging and enabling stent expansion within severely calcified occlusions often fails, which are observed in ~35% and ~20% of procedures, respectively.

[0116] Rotational atherectomy (RA) and orbital atherectomy (OA) are increasingly used to debulk otherwise untreatable lesions to enable PCI, with recent studies confirming RA and OA improve stent deliverability vs. standard PCI without negatively affecting14105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center outcomes. To debulk severely calcified lesion, RA / OA devices employ long (>300cm) stiff driveshafts which spin burs / crowns at speeds up to 180,000 RPM. For both RA and OA, the inflexible driveshaft often hinders access within tortuous vasculature. The high speeds employed are necessary to stabilize the bur / crown about a guidewire, without which, the tip would dangerously whip. However, the need for extreme rotational speeds greatly increases the complexity of RA / OA systems and presents risks, which include 1 ) thermal injury due to driveshaft friction, 2) arterial abrasion and perforation, 3) guidewire shattering, 4) bur / crown entrapment, and 5) embolic debris within the distal vasculature. To reduce the risk of traumatic injury, RA and OA devices cannot be used for more than five minutes.

[0117] Acute ischemic stroke (AIS) is due to an occlusion in the neurovasculature and is a leading cause of death and neurological disability in the United States (US). It is estimated that of nearly 700,000 annual AIS events, nearly half are within small distal cerebral vessels not amenable to thrombectomy. By 2030, AIS’s total economic burden is projected to exceed $180B in the US alone.

[0118] Early restoration of blood flow to the brain is critical to improve AIS patient outcomes. Although intravenous thrombolysis is beneficial, thrombolysis is underutilized due to its low efficacy and dose-dependent risk of symptomatic intracranial hemorrhage (sICH). Due to this risk, thrombolysis is generally not used for milder strokes, such as those associated with distal occlusions. In contrast to thrombolysis, thrombectomy is highly effective in recanalizing occluded proximal vessels; however, stent-retrieval and aspiration devices are too large to safely access distal emboli within small vessels. Furthermore, thrombectomy often generates embolic debris resulting in inaccessible secondary distal emboli. Although distal occlusions are known to result in poorer patient outcomes and more expensive hospitalizations, many physicians feel that attempting to mechanically remove distal emboli within small vessels presents safety risks. In an effort to improve patient outcomes, intraarterial thrombolytic administration post thrombectomy has been explored to lyse distal clots. However, thrombolytic agents are often diverted away from the occluded vessel due to the formation of natural stagnant blood columns proximal to distal clot. Even when high thrombolytic doses are administered directly within15105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center the occluded vessel, thrombolytic agent diffusion is slowed to a few millimeters per hour, resulting in little retained fibrinolytic activity by the time the thrombolytic reaches the clot. Taken together, distal neurovascular emboli are largely left untreated despite being known to result in poorer patient outcomes.

[0119] The catheters, systems, and methods described herein can be used in thrombectomies and / or atherectomies. The catheters, systems, and methods can be configured to break down or clear occlusions in a vein, blood vessel, artery, or cavity located in an arm, leg, brain, heart, neck, torso, or any body part of a patient. In some examples, the catheters, systems, and methods can be used to break down kidney stones or tumors in urinary or intestinal tracts. The catheters, systems, and methods provide significant benefits over current thrombectomy and atherectomy devices. For example, the catheters, systems, and methods described herein do not overheat, which is a significant drawback of current devices which require high rotation rates to achieve stability of a grinding bur or tip. Further, the catheters, systems, and methods described herein utilize guidewires operable to navigate complex vasculatures, providing significantly increased access to hard to reach occlusions. The catheters, systems, and methods also decrease the risk of perforation during occlusion breakdown and clearing, by providing increased control and location. The catheters, systems, and methods further provide significant benefits in decreased debris generation. Due to the decreased rotation rate as compared to current devices, the catheters, systems, and methods described herein generate significantly smaller debris, thereby increasing the safety of thrombectomy and atherectomy procedures.

[0120] Catheters and systems for breaking down or clearing an occlusion in a blood vessel, vein, cavity, or artery and / or mixing a fluid near the occlusion is provided herein. The system can include a catheter and an external magnet. In some examples, the catheter can include a catheter body and a magnetic tip rotatably mounted to the catheter body. The magnetic tip can be a magnetic rotor, magnetic bur, and / or a magnetic bit. The external magnet can be part of an external magnet assembly. In some examples, the catheter can include a magnetic tip rotatably mounted to the catheter. The external magnet can be operable to generate a magnet field operable to rotate the magnetic tip16105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center about an axis defined by the catheter. In some examples, the catheter described herein can be operable to grind an occlusion with a rotatable magnetic tip, provide therapeutic and / or diagnostic fluids through at least one lumen, and / or aspirate the occlusion site to remove unwanted material through at least one lumen, thereby clearing an occlusion.

[0121] FIG. 1 illustrates a catheter 100 of the system described herein in one example. The catheter 100 can include a catheter body 102 and a magnetic tip 104. The magnetic tip 104 can be rotatably coupled to the catheter body 102 such that the magnetic tip 104 can be rotated in relation to the catheter body 102. In some examples, the magnetic tip 104 can include a tip configured to grind, break down, clear an occlusion (e.g., lesion), mix a fluid for delivery to the occlusion (e.g., within the catheter 100 and / or outside of the catheter 100 within the blood vessel), and / or provide a vacuum pressure to aspirate the occlusion and / or portions of the occlusion. In some examples, the magnetic tip 104 can be configured to break down and / or grind an occlusion without the delivery of a thrombolytic or other therapeutic agent. The catheter 100 can define a longitudinal axis 101 about which the magnetic tip 104 can rotate. In some examples, the catheter 100 can include one or more lumens. The one or more lumens can be internal to the catheter 100 (e.g., contained within the catheter body 102). In some examples, the one or more lumens can include a guidewire lumen. The guidewire lumen can be configured to receive a guidewire. The catheter 100 can be located to a desired location by moving along the guidewire. In other examples, the catheter 100 can be navigated within a patient vasculature without the use of a guidewire.

[0122] FIG. 2 illustrates a catheter 100 of the system described herein in one example. As illustrated in FIG. 2, the catheter 100 can include a mounting mechanism (e.g., spindle 106) coupled to the catheter body 102. The magnetic tip 104 can be rotatably coupled to the spindle 106 such that the magnetic tip 104 rotates about the spindle 106. In some examples, the spindle 106 can provide a gap between a distal end of the catheter body 102 and a proximal end of the magnetic tip 104 (e.g., a gap between an edge of the catheter body 102 closest to an edge of the magnetic tip 104). In other examples, the magnetic tip 104 can be rotatably coupled to the catheter body 102 via17105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center other rotatable mounting mechanisms (e.g., slip joints, ball joints, or other types of rotatable mounting mechanisms).

[0123] In some examples, the catheter body 102 can further include a magnetic material at a distal end of the catheter body 102 to increase total magnetic mass. In some examples, the magnetic material in the catheter body 102 can be at a distal end (e.g., closest to the magnetic tip 104). In some examples, the magnetic material in the catheter body 102 can be platinum cobalt (PtCo), samarium cobalt (SmCo), neodymium iron boron (NdBFe), and / or bonded magnets. In some examples, the magnetic material in the catheter body 102 can increase deflection capabilities of the catheter 100 by the external magnet (e.g., increase a maximum angle of deflection of the catheter 100 and / or decrease a required strength of the magnetic field provided to deflect the catheter 100). Deflection as described herein refers to an angle of deflection of a distal end (e.g., nearest the occlusion) of the catheter 100 in relation to the proximal end (e.g., furthest from the occlusion) of the catheter 100.

[0124] In some examples, the magnetic tip 104 includes a selective surface covering a whole surface or a portion of a surface of the magnetic tip 104. In some examples, the selective surface can be configured to breakdown, debulk, and / or shear the occlusion. In some examples, the selective surface can be configured to convey fluids to and / or from the occlusion. In some examples, the selective surface can be configured to convey fluids to and / or from the occlusion site. In some examples, the selective surface can be an abrasive surface. The selective surface can include any surface configured to aid in breaking down and / or clearing an occlusion.

[0125] The magnetic tip 104 can include an abrasive surface. The abrasive surface can aid in dissolution and / or grinding of the occlusion when magnetic tip 104 is rotating. In some examples, an entire exterior surface of the magnetic tip 104 can have an abrasive surface. In some examples, only a portion of the exterior surface of the magnetic tip 104 has an abrasive surface. In some examples, only a distal tip (e.g., tip furthest away from the catheter body 102) of the magnetic tip 104 has an abrasive surface.

[0126] In some examples, the abrasive surface can be any surface configured to aid in emboli dissolution. In some examples, the abrasive surface can be any surface18105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center configured to increase a surface roughness of the magnetic tip 104. In some examples, the abrasive surface can be any surface configured to grind (e.g., break down) a lesion, occlusion, clot, or other type of blockage. In some examples, the lesion, occlusion, clot, or other type of blockage is in a blood vessel, vein, cavity, or artery of a patient.

[0127] In some examples, the abrasive surface of the magnetic tip 104 can be operable to breakdown and / or clear the occlusion without the use of a thrombolytic or other therapeutic agent. In other examples, the abrasive surface of the magnetic tip 104 can be operable to breakdown and / or clear the occlusion in conjunction with a delivered thrombolytic or other therapeutic agent.

[0128] In some examples, the magnetic tip 104 can include a coating 506, as illustrated, for example, in FIG. 17. The coating 506 can cover all or a portion of the magnetic tip 104. In some examples, the coating 506 can include a plurality of coatings. Each coating of the plurality of coatings can overlap. In some examples, each coating of the plurality of coatings can be applied to specific regions of the magnetic tip 104, such that some of coatings overlap and some of the coatings do not overlap, or none of the coatings overlap.

[0129] In some examples, the coating 506 can be an abrasive coating (e.g., abrasive surface). In some examples, the abrasive coating can include any coating configured to increase a surface roughness of the magnetic tip 104. In some examples, the abrasive coating can include a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, a bonded powdered metal coating, any other coating configured to increase a surface roughness of the magnetic tip 104, or a combination thereof. In some examples, the abrasive coating can include a bonded powdered metal. In some examples, the bonded powdered metal can include one or more of platinum, gold, silica and / or other metals.

[0130] In some examples, the abrasive surface can be formed on the magnetic tip 104 or portion of the magnetic tip 104. In some examples, the abrasive surface can include an etched surface, a knurled surface, a stippled surface, or any other surface configured to increase the surface roughness of the magnetic tip 104. In some examples, the abrasive surface can include a micropatterned surface.19105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0131] In some examples, the catheter 100 can include one or more lumens. For example, the catheter 100 can include 1 , 2, 3, or more lumens. The one or more lumens can allow additional tools and / or materials to be passed through the catheter 100 for use in breaking down and / or clearing an occlusion. In some examples, the one or more lumens can include one or more of a guidewire lumen, an aspiration lumen, and / or a fluid delivery lumen. In some examples, the guidewire lumen can be operable to receive a guidewire. In some examples, a guidewire can be located in a blood vessel, cavity, vein, or artery of a patient, such that the guidewire runs through or into an occlusion within the blood vessel, vein, or artery. The guidewire lumen can receive the guidewire, and the catheter 100 can be moved along the guidewire, such that the magnetic tip 104 contacts the occlusion.

[0132] The aspiration lumen can be in fluid communication with a vacuum pressure source. In some examples, the vacuum pressure source can provide a vacuum pressure though the catheter near the tip of the magnetic tip 104. As the magnetic tip 104 rotates, thereby breaking down the occlusion, the vacuum pressure source can pull debris from the occlusion through the aspiration lumen. In some examples, the vacuum pressure source includes a collection container for collecting the debris. In some examples, the rotation of the magnetic tip 104 can provide the vacuum pressure (e.g., a dedicated vacuum source may not be needed). For example, the rotation of the magnetic tip 104 can cause fluid flow towards the catheter body 102, thereby generating a negative pressure and aiding in aspiration of the occlusion site.

[0133] As illustrated, for example, in FIGS. 6 and 19, the catheter 100 can have one or more aspiration ports 204. The one or more aspiration ports 204 can be in fluid communication with the aspiration lumen, such that debris can be pulled into the one or more aspiration ports 204 to the aspiration lumen, thereby clearing debris from the occlusion site as the magnetic tip 104 breaks down the occlusion. In some examples, the one or more aspiration ports 204 can be disposed on circumferential surface of the catheter body 102. In some examples, the one or more aspiration ports 204 can be angled toward a distal end of the catheter 100 (e.g., towards a tip of the magnetic tip 104). In some examples, the one or more aspiration ports 204 can be disposed on a20105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center circumferential surface of the magnetic tip 104. In some examples, the one or more aspiration ports 204 can be disposed on a distal edge of the catheter body 102 (e.g., edge closest to the magnetic tip 104). In some examples, the one or more aspiration ports 204 disposed on the circumferential surface of the magnetic tip 104 can be angled toward a distal tip of the magnetic tip 104. In some examples, the one or more aspiration ports 204 can be disposed on a distal tip (e.g., furthest from the catheter body 102) of the magnetic tip 104. In some examples, the one or more aspiration ports 204 can include 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, or more aspiration ports. In some examples, the one or more aspiration ports 204 can be disposed on one or more of the circumferential surface of the catheter body 102, the circumferential surface of the magnetic tip 104, and the distal tip of the magnetic tip 104. In some examples, when the one or more aspiration ports 204 include two or more aspiration ports on the circumferential surface of the catheter body 102 and / or magnetic tip 104, the two or more aspiration ports can be evenly spaced about the circumferential surface.

[0134] It will be appreciated that the catheter 100 can have more than one aspiration lumen and more than one aspiration port 204. For example, the catheter 100 can include the same number of aspiration lumens as aspiration ports 204. Each aspiration lumen can have a dedicated aspiration port 204. In some examples, a single aspiration lumen can be in fluid communication with multiple aspiration ports 204.

[0135] The fluid delivery lumen can be in fluid communication with a fluid source. The fluid delivery source can be operable to provide a fluid to the occlusion through the fluid delivery lumen. In some examples, the fluid delivery source can include a pump or other pressure source operable to move a fluid from the fluid delivery source to the occlusion through the fluid delivery lumen. In some examples, the rotation of the magnetic tip 104 can cause the fluid to flow through the fluid delivery lumen to the occlusion (e.g., the rotation of the magnetic tip 104 can generate fluid flow towards the occlusion).

[0136] FIG. 17 illustrates a fluid delivery lumen 500. In some examples, the fluid 502 delivered to the occlusion site through the fluid delivery lumen 500 can include a diagnostic agent and / or a therapeutic agent. In some examples, the fluid 502 can be operable to aid in breakdown or clearing of the occlusion. In some examples, the fluid21105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center502 can be operable to aid in diagnosing the occlusion or affected areas around the occlusion site. In some examples, the fluid 502 can be operable to aid in imaging the occlusion and / or the occlusion site. In some examples, the fluid 502 can aid in breaking down the occlusion, diagnosing the occlusion and / or occlusion site, and / or imagining the occlusion and / or the occlusion site.

[0137] In some examples, fluid 502 can include one or more drugs, x-ray contrast agents, Von Willebrand factor, acids, neuroprotectants, DNAse, thrombolytics, other therapeutic agents, other diagnostic agents, or combinations thereof. In some examples, the fluid can include one or more thrombolytics. The one or more thrombolytics can be operable to aid in breaking down and / or clearing the occlusion. In some examples, the one or more thrombolytics can include one or more of alteplase, Tenecteplase, urokinase, desmoteplase, reteplase, and / or streptokinase. In some examples, the therapeutic agents can include chemotherapeutics, nanoparticle-based agents, and anticoagulants. In some examples, the diagnostic agents can include iodinated agents.

[0138] In some examples, as illustrated in FIGS. 5 and 19, the catheter 100 can include one or more fluid delivery ports 202. The one or more fluid delivery ports 202 can be in fluid communication with the fluid delivery source and the fluid delivery lumen 500, such that fluid 502 can be delivered to the occlusion and / or occlusion site through the one or more fluid delivery ports 202. In some examples, the one or more fluid delivery ports 202 can be disposed on circumferential surface of the catheter body 102, as illustrated, for example, in FIGS. 5 and 19. In some examples, the one or more fluid delivery ports 202 can be angled toward a distal end of the catheter 100 (e.g., towards a tip of the magnetic tip 104). In some examples, the one or more fluid delivery ports 202 can be disposed on a circumferential surface of the magnetic tip 104. In some examples, the one or more fluid delivery ports 202 can be disposed on a distal edge of the catheter body 102 (e.g., edge closest to the magnetic tip 104). In some examples, the one or more fluid delivery ports 202 disposed on the circumferential surface of the magnetic tip 104 can be angled toward a distal tip of the magnetic tip 104. In some examples, the one or more fluid delivery ports 202 can be disposed on a distal tip (e.g., furthest from the catheter body 102) of the magnetic tip 104. In some examples, the one or more fluid delivery ports22105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center202 can include 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, or more fluid delivery ports. In some examples, the one or more fluid delivery ports 202 can be disposed on one or more of the circumferential surface of the catheter body 102, the circumferential surface of the magnetic tip 104, and the distal tip of the magnetic tip 104. In some examples, when the one or more fluid delivery ports 202 include two or more fluid delivery ports on the circumferential surface of the catheter body 102 and / or magnetic tip 104, the two or more fluid delivery ports can be evenly spaced about the circumferential surface.

[0139] It will be appreciated that the catheter 100 can have more than one fluid delivery lumen 500 and more than one fluid delivery port 202. For example, the catheter 100 can include the same number of fluid delivery lumens 500 as fluid delivery ports 202. Each fluid delivery lumen 500 can have a dedicated fluid delivery port 202. When each fluid delivery lumen 500 has a dedicated fluid delivery port 202, multiple different fluids can be delivered at the same time. In some examples, a single fluid delivery lumen 500 can be in fluid communication with multiple fluid delivery ports 202.

[0140] In some examples, the one or more lumens can be concentric lumens. In some examples, the one or more lumens can be side-by-side lumens. In some examples, the one or more lumens can have different configurations. In some examples, the one or more lumens can be side-by-side lumens arranged horizontally, vertically, diagonally, or in other configurations.

[0141] While the guidewire lumen, fluid delivery lumen 500, and aspiration lumen can all be separate lumens, it will be appreciated that less than three separate lumens can perform the functions of the guidewire lumen, fluid delivery lumen, and aspiration lumen. For example, a single lumen can function to receive a guidewire, deliver fluid, and aspirate the occlusion site. In some examples, the at least one lumen can include a guidewire lumen and a second lumen. The second lumen can function as both the fluid delivery lumen and the aspiration lumen depending the flow generated within the lumen (e.g., flow can be generated by the vacuum source, fluid delivery source, and / or the magnetic tip 104).

[0142] The magnetic tip 104 can have a shape operable to break down, clear, grind, and / or dissolve an occlusion. In some examples, the magnetic tip 104 can have a23105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center dome shape (e.g., as illustrated in FIGS. 5-6), a prolate shape (e.g., as illustrated in FIG. 7 A), a cylindrical shape (e.g., as illustrated in FIG. 7B), a spherical shape, a cube shape, a cuboid shape, a triangular prism shape, or any other shape. In some examples, the magnetic tip 104 can have a dome shape that increases in diameter from a distal end furthest from the catheter body 102 to a proximal end closest to the catheter body 102. In some examples, the magnetic tip 104 can have a dome shape that increases in diameter from a proximal end closest to the catheter body 102 to a distal end furthest from the catheter body 102. In some examples, the magnetic tip 104 can include a net (e.g., mesh structure). In some examples, the net can be abrasive such that it breaks down and / or grinds the occlusion. In some examples, as the net rotates, the net can be operable to secure the occlusion. In some examples, as the net rotates and the occlusion is secured therein, the net can continue breaking down and / or grinding the occlusion (e.g., the interior surface of the net can have an abrasive surface).

[0143] In some examples, the magnetic tip 104 can have one or more wings (e.g., protrusions extending from a circumferential surface of the magnetic tip 104). The one or more wings can be triangular, cuboid, cylindrical, spherical, or any other shape. In some examples, the magnetic tip 104 can include 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, or more wings. In some examples, the one or more wings are configured to promote dissolution, breaking up, and / or clearing of the occlusion. In some examples, when the one or more wings comprise two or more wings, the two or more wings can be evenly spaced around the circumferential surface of the magnetic tip 104.

[0144] In some examples, the magnetic tip 104 can include one or more cutting edges. The one or more cutting edges can have a sufficient sharpness such that the one or more cutting edges break down an occlusion when the magnetic tip 104 is rotated and in contact with the occlusion. In some examples, the one or more cutting edges can be disposed on a distal tip of the magnetic tip 104. In some examples, the one or more cutting edges can be disposed on a circumferential surface of the magnetic tip 104.

[0145] In some examples, the magnetic tip 104 can include one or more grinding edges. The one or more grinding edges can be configured to break down an occlusion as the magnetic tip 104 rotates while in contact with the occlusion.24105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0146] In some examples, the magnetic tip 104 can have one or more cutting and / or grinding connotations.

[0147] In some examples, the magnetic tip 104 can have a cap with one or more of the shearing, grinding, or debulking components (e.g., surfaces, teeth, wings, cutting edges, grinding edges, abrasive surface, abrasive coatings, etc.) described herein. The cap can be configured to be secured (removably or permanently) to the magnetic tip 104.

[0148] In some examples, the magnetic tip 104 can include one or more teeth. In some examples, the one or more teeth can be disposed on the distal tip of the magnetic tip 104 furthest from the catheter body 102. In some examples, the one or more teeth can be disposed on a circumferential surface of the magnetic tip 104. In some examples, the one or more teeth can include 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, or more teeth. In some examples, when the one or more teeth include two or more teeth, the two or more teeth can be evenly spaced from one another.

[0149] In some examples, the magnetic tip 104 can have a diameter. In some examples, the diameter of the magnetic tip 104 can be about 0.1 mm to about 5 mm. In some examples, the diameter of the magnetic tip 104 can be about 0.1 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1 .5 mm, about 1 .5 mm to about 2 mm, about 2 mm to about 2.5 mm, about 2.5 mm to about 3 mm, about 3 mm to about 3.5 mm, about 3.5 mm to about 4 mm, about 4 mm to about 4.5 mm, about 4.5 mm to about 5 mm, or more. In some examples, the magnetic tip 104 can have a diameter of about 2 mm to about 3 mm.

[0150] In some examples, the magnetic tip 104 can have a length. In some examples, the length of the magnetic tip 104 can be about 0.1 mm to about 5 mm. In some examples, the length of the magnetic tip 104 can be about 0.1 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1 .5 mm, about 1 .5 mm to about 2 mm, about 2 mm to about 2.5 mm, about 2.5 mm to about 3 mm, about 3 mm to about 3.5 mm, about 3.5 mm to about 4 mm, about 4 mm to about 4.5 mm, about 4.5 mm to about 5 mm, or more. In some examples, the length of the magnetic tip 104 can be about 2 mm to about 3 mm.25105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0151] As illustrated in FIG. 3, the magnetic tip 104 can include helical grooves 200. In some examples, the helical grooves 200 can be configured to move the magnetic tip 104 and thereby the catheter 100 through a fluid (e.g., blood). For example, when the magnetic tip 104 is rotated, the helical grooves 200 can rotate, thereby displacing the fluid and moving the magnetic tip 104 and catheter forward or backward through the fluid. The direction of motion of the magnetic tip 104, and thereby the catheter 100, can depend on the orientation of the helical grooves and the rotation (e.g., clockwise or counterclockwise) of the magnetic tip 104. In this manner, an operator can control the position of the magnetic tip 104 by controlling the rotation direction of the magnetic tip 104. Further, since the helical grooves 200 will continue displacing fluid when the magnetic tip 104 contacts the occlusion, a force is provided to the occlusion by the magnetic tip 104, thereby aiding grinding of the occlusion and ensuring contact with the occlusion.

[0152] As illustrated in FIG. 4, the magnetic tip 104 can have a shape configured to stir (e.g., mix) a fluid. In some examples, the shape of the magnetic tip 104 stirs (e.g., mixes) a fluid within the magnetic tip 104 (e.g., when the fluid delivery lumen runs through the magnetic tip 104 to one or more fluid delivery ports disposed on the magnetic tip 104) and / or fluid outside (e.g., exterior to) the magnetic tip 104. In some examples, the shape configured to stir (e.g., mix) the fluid can be a curved shape, as illustrated, for example, in FIG. 4. In some examples, the magnetic tip 104 can have a spiral shape.

[0153] As illustrated in FIG. 5, the magnetic tip 104 can have a dome shape. In some examples, the magnetic tip 104 can be rotated, at least in part, by a pressurized fluid provided by the fluid delivery source described herein. In some examples, the magnetic tip 104 can have a distal tip which rotates based on the magnetic field provided by the external magnet, and a body which rotates in an opposite direction of the magnetic tip from the force provided by the pressurized fluid. For example, the magnetic tip 104 body can be rotated by the pressurized fluid delivered through the fluid delivery lumen and exiting the one or more fluid delivery ports 202 on a distal edge of the catheter body 102. In some examples, when the distal tip of the magnetic tip 104 and the body of the magnetic tip 104 rotate in opposite directions, the opposing rotations can form a vortex, which can aid in fluid mixing.26105119194.4PATENT Attorney Docket No. 104954-835903 Via Patent Center

[0154] As illustrated in FIG. 6, the magnetic tip 104 can have a dome shape. In some examples, the magnetic tip 104 can be rotated, at least in part, by fluid being pulled into the catheter body 102 via one or more aspiration ports 204, as a result of a vacuum pressure provided by the vacuum source described herein. In some examples, the magnetic tip 104 tip can be rotated by the external magnet and a magnetic tip body 201 can be rotated by the flow of fluid caused by the vacuum pressure. For example, the vacuum source can provide a vacuum pressure to the aspiration lumen, which is in fluid communication with the one or more aspiration ports 204. When fluid and / or debris passes by the magnetic tip body 201 , the magnetic tip body 201 can be rotated by the fluid and / or debris and the external magnet can rotate the magnetic tip 104 in an opposite direction of the rotation of the magnetic tip body 201 , thereby forming a vortex.

[0155] In some examples, the rotation of the magnetic tip 104 is operable to provide a vacuum pressure and pull debris and / or fluid into the one or more aspiration ports 204. In this example, a separate vacuum pressure source may not be necessary, as the magnetic tip 104 rotation is operable to create the vacuum pressure necessary to pull debris and / or fluid into the one or more aspiration ports 204 and through the aspiration lumen.

[0156] As illustrated in FIG. 18, the magnetic tip 104 of the catheter 100 can include a hollow cylinder (e.g., a cylindrically shaped magnetic tip 104 with an open inner lumen 112). In some examples, the magnetic tip 104 can be rotatably coupled to the catheter body 102 at a slip joint 114. The slip joint 114 can be operable to allow the magnetic tip 104 to rotate in relation to the catheter body 102 (e.g., rotate about longitudinal axis 101 ). In some examples, the magnetic tip 104 can be rotated by a magnetic field provided by the external magnet described herein.

[0157] In some examples, the magnetic tip 104 can include a north magnetic body portion 103 and a south magnetic body portion 105. The north magnetic body portion 103 can include a north magnetization 107. The south magnetic body portion 105 can include a south magnetization 109. The north magnetization 107 and the south magnetization 109 can allow the magnetic tip 104 to rotate in response to an applied magnetic field. InIT105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center some examples, the north magnetic body portion 103 and the south magnetic body portion 105 can be formed from a single magnet body or multiple magnet bodies.

[0158] In some examples, the magnetic tip 104 can include a permanent magnetic material. In some examples, the magnetic tip 104 can include a permeable magnetic material. In some examples, the magnetic tip 104 can include but is not limited to neodymium boron iron, samarium cobalt, platinum cobalt, and / or platinum iron materials.

[0159] In some examples, the magnetic tip 104 can be operable to grind and / or break down the occlusion 92 while providing a vacuum force to aspirate the occlusion 92 within a blood vessel 90. For example, the inner lumen 112 of the magnetic tip 104 can be operable to receive fluid and / or broken down pieces of the occlusion 92. In this manner, extracted material from the occlusion 92 can be collected in the inner lumen 112 of the magnetic tip 104. In some examples, the extracted material can include blood clot debris, blood clot, platelet rich clots, platelet rich clot debris, calcium rich clots, and / or calcium rich clot debris.

[0160] In some examples, the magnetic tip 104 can include a cover 116. The cover 116 can be located on a distal surface (e.g., surface operable to contact the occlusion 92). The cover 116 can include the distal-most surface of the magnetic tip 104 surrounding the open inner lumen 112 (e.g., hollow portion) of the magnetic tip 104. In some examples, the cover 116 can be configured to promote engagement with the occlusion 92. For example, the cover 116 can include a shape and / or material configured to promote engagement with the occlusion. In some examples, the cover 116 can include a shape and / or material configured to promote mixing of a fluid delivered to the occlusion 92. In some examples, the cover 116 can include a shape and / or material configured to aid in breaking down (e.g., grinding) the occlusion 92. In some examples, the cover 116 can have any of the shapes and / or abrasive surfaces described herein configured to promote engagement with the occlusion 92, aid in mixing a fluid for delivery to the occlusion 92, and / or configured to aid in breaking down (e.g., grinding the occlusion). For example, the cover 116 can include any of the abrasive surfaces described herein (e.g., diamond powder coating, etc.).28105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0161] In some examples, the catheter body 102 can include one or more fluid delivery ports 202. For example, the one or more fluid delivery ports 202 can be in fluid communication with the fluid delivery lumen 500 described herein. In some examples, the one or more fluid delivery ports 202 can be operable to deliver one or more fluids to the occlusion 92. In some examples, the one or more fluids can include any of the fluids described herein (e.g., thrombolytic agents and / or diagnostic agents). In some examples, the inner lumen 112 of the magnetic tip 104 can be operable to deliver the one or more fluids. For example, the inner lumen 112 can include one or more fluid delivery ports 202 for delivering the one or more fluids (e.g., therapeutic and / or diagnostic agents described herein).

[0162] In some examples, the catheter body 102 can include one or more aspiration ports 204. The one or more aspiration ports 204 can be configured to aspirate unwanted materials (e.g., blood clot debris and / or excess amounts of fluid (e.g., therapeutic agents such as thrombolytic agents)). In some examples, the rotation of the magnetic tip 104 can provide a vacuum force to cause unwanted materials to be received by the one or more aspiration ports 204. In some examples, a separate vacuum pressure source can be used to draw unwanted material into the one or more aspiration ports 204.

[0163] In some examples, the one or more aspiration ports 204 and the one or more fluid delivery ports 202 can be operable to circulate the one or more fluids (e.g., therapeutic agents and / or diagnostic agents) near the occlusion 92. For example, the flow through the one or more fluid delivery ports 202 and the one or more aspiration ports 204 can be reversed (e.g., a vacuum pressure (e.g., negative pressure) can be provided to the one or more fluid delivery ports 202 and a positive pressure can be provided to the one or more aspiration ports 204). In this manner, the one or more fluids (e.g., therapeutic agents and / or diagnostic agents) can be circulated around the occlusion 92, thereby promoting chemical engagement of the one or more fluids with the occlusion 92.

[0164] FIG. 19 illustrates another example of a catheter 100. As illustrated in FIG. 19, the catheter 100 can include a magnetic tip 104 contained within the catheter body 102. In this example, the magnetic tip 104 can include one or more propellers 210. In some examples, the one or more propellers 210 can include 2, 3, 4, or more propellers.29105119194.4PATENTAttorney Docket No. 104954-835903Via Patent CenterIn some examples, the one or more propellers 210 can be operable to generate fluid flow as the magnetic tip is rotated. For example, the one or more propellers 210 can be angled such that fluid flow can be generated out of the catheter body 102 and / or into the catheter body 102. In some examples, the rotation direction of the magnetic tip 104 can determine whether flow is generated into the catheter body 102 and / or out of the catheter body 102.

[0165] In some examples, the magnetic tip 104 can be rotated by the external magnet described herein. In some examples, the rotation of the magnetic tip 104 within the catheter body 102 can generate fluid flow within the catheter body 102 (e.g., via the one or more propellers 210).

[0166] In some examples, the magnetic tip 104 can include a north magnetic body portion 103 and a south magnetic body portion 105. The north magnetic body portion 103 can include a north magnetization 107. The south magnetic body portion 105 can include a south magnetization 109. The north magnetization 107 and the south magnetization 109 can allow the magnetic tip 104 to rotate in response to an applied magnetic field. In some examples, the north magnetic body portion 103 and the south magnetic body portion 105 can be formed from a single magnet body or multiple magnet bodies.

[0167] In some examples, the generation of fluid flow can provide a vacuum pressure at the distal tip of the catheter 100 (e.g., the tip nearest the occlusion 92). Generating fluid flow at the distal tip of the catheter 100 can prevent the distal tip from pinching or collapsing as a result of the vacuum pressure. For example, in conventional aspiration catheters, vacuum pressure is generated at the proximal end of the catheter (e.g., farthest away from the occlusion 92). Generating the vacuum pressure at the proximal end can cause pinching or collapsing of the catheter body 102 near the distal end. To prevent this, a stiff outer lumen with a thick wall is needed, which results in the outer diameter of the catheter body 102 being larger and the catheter being stiffer. Consequently, conventional aspiration catheters are too large for smaller vessels and cannot be as easily navigated to the occlusion 92 due to the conventional aspiration catheters stiffness.

[0168] The catheter 100 illustrated in FIG. 19 overcomes these limitations. Specifically, the magnetic tip 104 rotates within the catheter body 102 near the distal end30105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center of the catheter 100, thereby generating the vacuum pressure (e.g., aspiration pressure) near the distal end of the catheter 100. By generating vacuum pressure at near the distal end of the catheter 100, the tendency of the catheter 100 to pinch closed is overcome. Further, generating vacuum pressure alleviates the need for the stiff and thick outer lumen of conventional catheters, thereby allowing the catheter 100 to be smaller and more pliable. Since the catheter 100 is smaller and more pliable, the catheter 100 can more easily access the occlusion 92 and navigate through more tortuous vessels.

[0169] In some examples, the magnetic tip 104 can be rotated in a first direction to provide the vacuum pressure. The vacuum pressure can cause unwanted material of the occlusion 92 (e.g., blood clot debris, blood clot, platelet rich clots, platelet rich clot debris, calcium rich clots, and / or calcium rich clot debris) to be removed from the occlusion site. For example, as the magnetic tip 104 rotates the unwanted material can be sucked into the inner lumen 112 of the catheter body 102 and out of the body of the patient.

[0170] In some examples, the magnetic tip 104 can be rotated in a second direction to provide a positive pressure to the occlusion 92. For example, the magnetic tip 104 can be rotated in a second direction to cause fluid flow within the catheter 100 towards the occlusion 92. In some examples, one or more fluids (e.g., therapeutic and / or diagnostic agents) can be provided to the occlusion 92 when the magnetic tip 104 is rotated in the second direction. For example, when the magnetic tip 104 is rotated in the second direction, the positive pressure generated can be operable to pull the one or more fluids (e.g., therapeutic and / or diagnostic agents) through the fluid delivery lumen and towards the occlusion 92. In some examples, the one or more fluids delivered to the occlusion 92 can include any of the therapeutic and / or diagnostic fluids described herein. For example, therapeutic agents can include alteplase, Tenecteplase, urokinase, reteplase, streptokinase, desmoteplase, chemotherapeutics, nanoparticle-based agents, and / or anticoagulants. For example, diagnostic agents can include imaging agents such as iodinated agents.

[0171] In some examples, the magnetic tip 104 can be sequentially switched between rotation in the first direction and rotation in the second direction to assist with aspiration and / or fluid delivery, respectively. In some examples, the magnetic tip 10431105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center rotation direction can be reversed overtime, thereby reversing the fluid flow direction over time and generating a back and forth pressure to assist in aspiration and / or fluid delivery.

[0172] In some examples, the vacuum pressure and / or positive pressure generated by the magnetic tip can be assisted by a vacuum pressure source and or fluid delivery source at the proximal end (e.g., furthest from the occlusion 92) of the catheter 100. For example, in conjunction with the pressure generated at the distal end by the magnetic tip 104, the vacuum pressure source and / or fluid delivery source described herein can be used to generate pressure at the proximal end of the catheter 100.

[0173] In some examples, the catheter 100 can include multiple magnetic tips 104 having one or more propellers 210. For example, multiple magnetic tips 104 can be contained within the inner lumen 112 of the catheter body 102. In some examples, the multiple magnetic tips 104 can be arranged sequentially within the inner lumen 112. In some examples, utilizing multiple magnetic tips 104 can generate increased flow rates within the inner lumen 112.

[0174] In some examples, the magnetic tip 104 can include permanent or permeable magnetic material. For example, the magnetic tip 104 can include neodymium boron iron, samarium cobalt, platinum cobalt, and / or platinum iron materials.

[0175] In some examples, the one or more propellers 210 can be configured to breakdown and / or grind the occlusion 92. For example, the one or more propellers 210 can include any of the abrasive surfaces (e.g., abrasive coatings) described herein.

[0176] In some examples, the catheter 100 can have a tapered shape. For example, the distal end of the catheter 100 (e.g., the end of the catheter 100 having the magnetic tip 104) can have a smaller diameter than a proximal end of the catheter 100 (e.g., the end of the catheter 100 furthest away from the occlusion 92). The tapered shape of the catheter 100 can assist in aspirating material from the occlusion site (e.g., the tapered shape can allow for increased vacuum pressure and / or positive pressure near the occlusion 92).

[0177] FIG. 20 illustrates another example of a catheter 100. In some examples, the catheter 100 can include a magnetic tip 104 operable to rotate and move orbitally. For example, the magnetic tip 104 can be coupled to the catheter body 102 via a ball joint32105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center115. The ball joint 115 can allow for movement of the magnetic tip 104 in multiple directions. For example, the magnetic tip 104 can rotate about the longitudinal axis 101 as the magnetic tip 104 is provided a magnetic field by the external magnet described herein. The magnetic tip 104 can also be operable to move orbitally about the ball joint 115 as the magnetic tip 104 is provided a magnetic field by the external magnet. The orbital movement of the magnetic tip 104 can allow the magnetic tip 104 to contact a greater surface area of the occlusion 92, thereby allowing grinding of a greater surface area of the occlusion. In some examples, the ball joint 115 can allow the magnetic tip 104 to be steered by the external magnet in desired directions.

[0178] The magnetic tip 104 can be diametrically magnetized. In some examples, the magnetic tip 104 can include a north magnetic body portion 103 and a south magnetic body portion 105. The north magnetic body portion 103 can include a north magnetization 107. The south magnetic body portion 105 can include a south magnetization 109. The north magnetization 107 and the south magnetization 109 can allow the magnetic tip 104 to rotate in response to an applied magnetic field. The north magnetization 107 and the south magnetization 109 can be orthogonal to the longitudinal axis 101. In some examples, the north magnetic body portion 103 and the south magnetic body portion 105 can be formed from a single magnet body or multiple magnet bodies.

[0179] In some examples, the inner lumen 112 of the catheter 100 can be operable to receive a guidewire. The catheter 100 can be guided through the blood vessel 90 to the occlusion 92 by the guidewire. In some examples, the inner lumen 112 can be operable to deliver one or more fluids to the occlusion 92. For example, once the catheter 100 is located proximal the occlusion 92, the guidewire can be removed and the one or more fluids (e.g., therapeutic agents and / or diagnostic agents described herein) can be delivered to the occlusion via the inner lumen 112. In some examples, the inner lumen 112 can be operable to provide a vacuum pressure to aspirate the occlusion site. For example, a vacuum pressure source can be coupled to the inner lumen and provide a vacuum pressure to aspirate the occlusion site. In some examples, the inner lumen 112 can provide all three functions (e.g., fluid delivery, guidewire reception, and aspiration).33105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0180] In some examples, when a guidewire is contained within the inner lumen 112, the magnetic tip 104 can rotate about the guidewire. In some examples, when the guidewire is removed from the inner lumen 112, the magnetic tip 104 can move orbitally and / or rotate with respect to the ball joint 115.

[0181] In some examples, magnetic tip 104 can move orbitally about the guidewire. For example, the inner lumen 112 can have a larger diameter than the guidewire, such that the magnetic tip 104 moves orbitally about the guidewire (e.g., since the inner lumen 112 has a larger diameter than the guidewire, the magnetic tip 104 may move orbitally about the guidewire as well as rotate about the guidewire).

[0182] In some examples, the inner lumen 112 and the longitudinal axis 101 are not centered with a geometric centerline of the magnetic tip 104. When the inner lumen 112 and the longitudinal axis 101 are not centered with the geometric centerline of the magnetic tip 104, and one or more fluids are delivered through the inner lumen 112, the one or more fluids can spray out of the inner lumen 112 in a circular pattern as the magnetic tip 104 rotates.

[0183] In some examples, the catheter body 102 can further include one or more fluid delivery ports 132 and / or one or more aspiration ports 134. In some examples, as illustrated in FIG. 20, the one or more fluid delivery ports 132 and / or the one or more aspiration ports 134 can be a single port operable to selectively provide fluid delivery and aspiration. For example, a single port can be operable to provide both fluid delivery (e.g., a fluid source can provide the one or more fluids described herein through the single port) and aspiration (e.g., a vacuum source can be operable to provide a vacuum pressure to aspirate the occlusion site via the single port).

[0184] In some examples, the magnetic tip 104 can include a shape configured to promote grinding of the occlusion and / or improve fluid mixing. For example, the magnetic tip 104 can have a shape configured to increase turbulence to improve fluid mixing. The shape of the magnetic tip 104 can include any of the shapes described herein. For example, the magnetic tip can include a prolate spheroid, oblate spheroid, or any other shape described herein. In some examples, the magnetic tip 104 can have the selective surface described herein. In some examples, the magnetic tip 104 can include grooves34105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center and / or fins, as described herein. The magnetic tip 104 can include helical, hatched, or straight grooves. In some examples, the magnetic tip 104 can include toroidal, tapered, straight, or curved fins. In some examples, the magnetic tip 104 can include an abrasive surface, as described herein. For example, the magnetic tip 104 can include an abrasive coating (e.g., diamond powder coating, aluminum oxide coating, and / or silica coating). In some examples, the magnetic tip 104 can include a therapeutic coating such as a thrombolytic agent coating. The magnetic tip 104 can have multiple coatings as described herein.

[0185] In some examples, the magnetic tip 104 can include a spindle within the inner lumen 112 or another lumen of the magnetic tip 104. The magnetic tip 104 can be operable to rotate about the spindle (e.g., spindle 106 illustrated in FIG. 2). In some examples, the catheter body 102 can include one or more wire lumens operable to contain one or more wires. In some examples, the one or more wire lumens can be separate lumens from the other lumens described herein (e.g., fluid delivery lumen, guidewire lumen, and / or aspiration lumen) or can be the same lumens as the other lumens described herein. In some examples, the one or more wires can be operable to lock an orbital position of the magnetic tip 104 with respect to the ball joint 115. In this manner, the magnetic tip 104 can be operable to rotate about the spindle in a desired orbital position with respect to the catheter body 102, thereby allowing focused grinding at a specific location of the occlusion 92. For example, the orbital position of the magnetic tip 104 can be locked at an angle with respect to the longitudinal axis 101 and rotate about an axis defined by the angle from the longitudinal axis 101.

[0186] FIGS. 21A-21 C illustrate another example of a catheter 100. The catheter 100 can have a magnetic tip 104 coupled to a catheter body 102. In some examples, the magnetic tip 104 can be operable to rotate orbitally. For example, the magnetic tip 104 can be coupled to the catheter body 102 such that the magnetic tip 104 can rotate orbitally (e.g., via a ball joint or other coupling mechanism operable to allow the magnetic tip 104 to rotate orbitally).

[0187] As illustrated in FIG. 21 A an external magnetic field 600 can be applied perpendicular to the longitudinal axis 101 to rotate the magnetic tip 104 about the35105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center longitudinal axis. When the external magnetic field 600 is applied perpendicular to the magnetic tip 104, the magnetic tip 104 can rotate about the longitudinal axis.

[0188] As illustrated in FIG. 21 B, an external magnetic field 602 can be applied at an angle with respect to the longitudinal axis 101. For example, the external magnetic field 602 can be applied at an angle such that the magnetic tip 104 moves orbitally with respect to the longitudinal axis 101. When the external magnetic field 602 is applied, the magnetic tip 104 can be deflected to an orbital angle, as illustrated in FIG. 21 B. As the external magnetic field 602 is applied, the magnetic tip 104 can rotate about an axis defined by the orbital angle. In some examples, rotating the magnetic tip 104 about the axis defined by the orbital angle induces increased turbulence for mixing at the occlusion 92.

[0189] As illustrated in FIG. 21 C, an external magnetic field 604 can be applied at an angle with respect to the longitudinal axis 101. For example, the external magnetic field 604 can be applied at an angle such that the magnetic tip 104 moves orbitally with respect to the longitudinal axis 101. When the external magnetic field 604 is applied, the magnetic tip 104 can be deflected to an orbital angle, as illustrated in FIG. 21 C. As the external magnetic field 604 is applied, the magnetic tip 104 can rotate about an axis defined by the orbital angle. In some examples, rotating the magnetic tip 104 about the axis defined by the orbital angle induces increased turbulence for mixing at the occlusion 92.

[0190] As illustrated in FIGS. 21A-21C, the external magnetic fields 600, 602, 604 can determine the orbital angle, and thereby axis, about which the magnetic tip 104 rotates. By alternating which external magnetic field 600, 602, 604 is applied, turbulence can be increased within the blood vessel near the occlusion 92. In this manner, the magnetic tip 104 can act as a paddle to more efficiently mix fluids 502 (e.g., any of the fluids described herein) delivered to the occlusion 92.

[0191] FIGS. 23A-23Y and FIGS. 24A-24G illustrate another example of a catheter 100 and components of the catheter 100. The catheter 100 can have similar features and functionality as the catheter 100 of FIGS. 21A-21 C. FIG. 23D illustrates the components of the catheter 100. The catheter 100 can include a catheter body 102. The catheter body36105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center102 can include at least one lumen operable to house various components, deliver fluids, and / or aspirate an occlusion site. The catheter 100 can include a first magnetic tip connector portion 2302(a) and a second magnetic tip connector portion 2302(b). The catheter 100 can include a fluid delivery lumen 2310 in fluid communication with the inner lumen 112. In some examples, the catheter 100 can include a localization sensor 2308 housed within the catheter body 102, the first magnetic tip connector portion 2302(a), and / or the second magnetic tip connector portion 2302(b). The catheter can include a magnetic tip assembly. The magnetic tip assembly can include a magnetic tip holder 2301 , a magnetic tip 104, a spindle 2306, and a cap 2300. The magnetic tip holder 2301 can include a ball 2304 operable to be received in a ball joint socket of the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b). The magnetic tip 104 can be rotatably coupled to the magnetic tip holder 2301 via a spindle 2306 and the cap 2300. In some examples, a guidewire 300 can be received within the inner lumen 112 of the catheter 100 (e.g., the inner lumen 112 described herein).

[0192] In some examples, the localization sensor 2308 can include any sensor operable to provide location information for locating the catheter 100 within a patient.

[0193] The catheter 100 can include a magnetic tip connector. The magnetic tip connector can be coupled to the catheter body 102. In some examples, the magnetic tip connector can be friction fit to the catheter body 102. In some examples, other coupling mechanisms (e.g., snap fit connectors, threaded connectors, etc. can be used to couple the magnetic tip connector to the catheter body 102. The magnetic tip connector can include a first magnetic tip connector portion 2302(a) and a second magnetic tip connector portion 2302(b). In some examples, the magnetic tip connector (e.g., first magnetic tip connector portion 2302(a) and second magnetic tip connector portion 2302(b)) can include a ball joint connector (e.g., ball joint socket or ball joint opening) operable to receive a ball.

[0194] FIGS. 23Q-23V illustrate the first magnetic tip connector portion 2302(a). The first magnetic tip connector portion 2302(a) can include a ball joint housing 2318(a). In some examples, the ball joint housing 2318(a) can be operable to house a ball joint connector portion 2312(a) (e.g., ball joint socket portion). The ball joint connector portion37105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center2312(a) can be operable to form a full ball joint connector (e.g., full ball joint socket) with ball joint connector portion 2312(b) of the second magnetic tip connector portion 2302(b) (e.g., illustrated in FIG. 23W). In some examples, the first magnetic tip connector portion 2302(a) can be operable to house, at least partially, the localization sensor 2308. For example, the first magnetic tip connector portion 2302(a) can include a sensor lumen 2316 operable to house, at least partially, the localization sensor 2308.

[0195] In some examples, the first magnetic tip connector portion 2302(a) can include a fluid lumen 2314. The fluid lumen 2314 can include the fluid delivery lumen 2310 (e.g., can house the fluid delivery lumen 2310 or simply be an extension of (e.g., in fluid communication with) the fluid delivery lumen 2310). In some examples, the fluid delivery lumen 2314 can be operable to provide fluid to the inner lumen 112, as described herein.

[0196] In some examples, the first magnetic tip connector portion 2302(a) can include one or more holes 2320(a). In some examples, the one or more holes 2320(a) can reduce a weight of the first magnetic tip connector portion 2302(a). In some examples, the one or more holes can allow for fluid to be provided to the blood vessel. For example, fluid can be provided to a lumen in the catheter body 102. The fluid can then flow out of the one or more holes 2320(a) near the ball joint housing 2318(a). The fluid can be any of the therapeutic and / or diagnostic fluids described herein.

[0197] FIGS. 23W-23Y and FIGS. 24A-24C illustrate the second magnetic tip connector portion 2302(b). The second magnetic tip connector portion 2302(b) can include a ball joint housing 2318(b). In some examples, the ball joint housing 2318(b) can be operable to house a ball joint connector portion 2312(b) (e.g., ball joint socket portion). The ball joint connector portion 2312(b) can be operable to form a full ball joint connector (e.g., full ball joint socket) with ball joint connector portion 2312(a) of the first magnetic tip connector portion 2302(a). In some examples, the second magnetic tip connector portion 2302(b) can be operable to house, at least partially, the localization sensor 2308. For example, the second magnetic tip connector portion 2302(b) can include a sensor lumen 2316 operable to house, at least partially, the localization sensor 2308. In some examples, the sensor lumen 2316 of the second magnetic connector portion 2302(b) and the sensor lumen 2316 of the first magnetic connector portion 2302(a) each have half-38105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center circle cross sections which abut against one another to form a full sensor lumen 2316 when the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) are installed in the catheter body 102. In some examples, the sensor lumen 2316 of the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) can be coupled together to form a fluid tight seal. In other examples, the dimensions of the catheter body 102 and the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) may be sized such that the sensor lumen is fluid tight simply by abutting the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) against one another.

[0198] In some examples, the second magnetic tip connector portion 2302(b) can include a fluid lumen 2314. The fluid lumen 2314 can include the fluid delivery lumen 2310 (e.g., can house the fluid delivery lumen 2310 or simply be an extension of (e.g., in fluid communication with) the fluid delivery lumen 2310). In some examples, the fluid delivery lumen 2314 can be operable to provide fluid to the inner lumen 112, as described herein. Similar to the sensor lumen 2316, the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) can both include a half-circle cross section of the fluid lumen, such that when the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) the half-circle cross sections of the fluid lumen 2314 abut against one another (or are otherwise connected) to form the fluid lumen 2314.

[0199] In some examples, the second magnetic tip connector portion 2302(b) can include one or more holes 2320(b). In some examples, the one or more holes 2320(b) can reduce a weight of the first magnetic tip connector portion 2302(b). In some examples, the one or more holes can allow for fluid to be provided to the blood vessel. For example, fluid can be provided to a lumen in the catheter body 102. The fluid can then flow out of the one or more holes 2320(b) near the ball joint housing 2318(b). The fluid can be any of the therapeutic and / or diagnostic fluids described herein.

[0200] In some examples, the ball joint housings 2318(a), 2318(b) can include a length 2313. In some examples, the length 2313 can be about 1 mm to about 5 mm. In39105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center some examples, the first magnetic connector portion 2302(a) and the second magnetic connector portion 2302(b) can have a length 2315. In some examples, the length 2315 can be about 3 mm to about 10 mm. In some examples, the length 2315 can be about 4 mm to about 7 mm. In some examples, the length 2315 can be about 6 mm.

[0201] In some examples, the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) can be coupled to one another via coupled mechanisms. For example, the first magnetic tic connector portion 2302(a) and the second magnetic tip connector portion 2302(b) can be coupled to one another via snap- fit mechanisms, threaded connectors, via friction fit within the catheter body 102, or any other type of coupling mechanism.

[0202] The magnetic tip assembly of the catheter 100 can include a magnetic tip holder 2301 , as illustrated, for example, in FIGS. 24D-24G. The magnetic tip holder 2301 can include a ball 2304. The ball 2304 can be received within the ball joint connector portions 2312(a), 2312(b). In some examples, the magnetic tip holder 2301 can move orbital ly with respect to the catheter body 102 due to the ball 2304 and ball joint connector portions 2312(a), 2312(b). For example, the magnetic tip holder 2301 can be moved orbitally due to the external magnetic field applied to the magnetic tip 104, as described herein.

[0203] In some examples, the magnetic tip holder 2301 can further include an inner lumen 112. The inner lumen can be in fluid communication with the fluid delivery lumen 2314 of the catheter body 102, thereby allowing fluid flow through the magnetic tip holder 2301. In some examples, the inner lumen 112 can be operable to receive fluid from the fluid lumen 2314 of the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b). For example, the inner lumen can include flange 2322 operable to place the inner lumen 112 in fluid communication with the fluid lumen 2314, and thereby the fluid delivery lumen 2310.

[0204] In some examples, the inner lumen 112 can further be operable to receive the spindle 2306. In some examples, the magnetic tip holder 2301 can couple to the spindle 2306, such that the spindle 2306 does not rotate with respect to the magnetic tip holder 2301. In some examples, the spindle 2306 can include a lumen running40105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center therethrough, such that fluid can be received and transferred through the spindle 2306. In other examples, the magnetic tip holder 2301 can include a spindle coupling mechanism 2330 (e.g., snap-fit mechanism or other coupling mechanism) operable to couple to the spindle 2306.

[0205] In some examples, the magnetic tip holder 2301 can have a distal end diameter 2319 (e.g., diameter opposite of the ball 2304). In some examples, the distal end diameter 2319 can be about 1 mm to about 5 mm. In some examples, the distal end diameter 2319 can be about 2 mm to about 3 mm. In some examples, the magnetic tip holder 2301 can have a length 2321 . In some examples, the length 2321 can be about 1 mm to about 5 mm. In some examples, the length 2321 can be about 2 mm to about 3 mm.

[0206] The magnetic tip assembly can further include a magnetic tip 104. The magnetic tip 104 can be rotatably mounted to the spindle 2306. The magnetic tip 104 can include any of the materials, shapes, coatings, surfaces, and / or other features described herein.

[0207] The magnetic tip assembly can further include a cap 2300, as illustrated, for example, in FIGS. 23M-23P. The cap 2300 can be operable to coupled to the spindle 2306 and / or the magnetic tip 104 near the distal end (e.g., furthest from the catheter body 102) of the magnetic tip 104. In some examples, the cap 2300 can be coupled to the magnetic tip 104 and rotatably mounted to the spindle 2306, such that the cap 2300 rotates with the magnetic tip 104. In other examples, the cap 2300 can be coupled to the spindle 2306 via spindle coupling mechanism 2311 , such that the cap 2300 does not rotate with respect to the spindle 2306.

[0208] When the cap 2300 is rotatably mounted to the spindle 2306 and rotates with the magnetic tip 104, the cap 2300 can include any of the selective surfaces (e.g., abrasive surfaces) described herein. For example, the cap 2300 can include any of the surfaces, shapes, or other features configured to grind or break down an occlusion as described herein.

[0209] The cap 2300 can include the inner lumen 112. In some examples, the inner lumen 112 can include a flanged distal end 2303. In some examples, the flanged distal41105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center end 2303 can facilitate greater fluid dispersion (e.g., the flanged distal end 2303 increases the area of fluid dispersion).

[0210] In some examples, the cap 2300 can have a length 2305. In some examples, the length 2305 can be about 0.5 mm to about 2 mm. In some examples, the length 2305 can be about 1 mm. In some examples, the cap 2300 can have a diameter 2307. In some examples, the diameter 2307 can be about 1 mm to about 5 mm. IN some examples, the diameter 2307 can be about 2 mm to about 3 mm.

[0211] In some examples, the inner lumen 112 can be operable to receive a guidewire 300, as illustrated, for example, in FIG. 23K. In some examples, the inner lumen 112 can be operable to provide fluid to the distal end of the catheter 100. In some examples, the inner lumen 112 can provide fluid (e.g., allow fluid flow) around the guidewire 300.

[0212] In some examples, the catheter of FIGS. 23A-24G can be assembled as follows. First, the spindle 2306 can be attached to the spindle coupling mechanism 2330 of the magnetic tip holder 2301 . Next, the magnetic tip 104 can be rotatably mounted on the spindle 2306. The cap 2300 can then be coupled to the spindle 2306 (e.g., via mounting mechanism 2311 ) or directly to the magnetic tip 104. Then the ball 2304 can be installed in the ball connector portions 2312(a), 2312(b). The first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) can then be coupled together. Next, the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) can be installed in the catheter body 102. In some examples, the localization sensor 2308 can be placed in the localization sensor lumen 2316 prior to the first magnetic tip connector portion 2302(a) and the second magnetic tip connector portion 2302(b) being attached to the catheter body 102. In other examples, the localization sensor 2308 can be received in the localization sensor lumen 2316 after the first magnetic connector portion 2302(a) and the second magnetic connector portion 2302(b) are coupled to the catheter body 102. Once the catheter 100 is properly assembled, the catheter 100 can be used to break down and / or clear in an occlusion in a blood vessel.42105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0213] In some examples, an external magnetic field can be applied to the magnetic tip to articulate the magnetic tip 104, and thereby the magnetic tip holder 2301 and the cap 2300 orbitally with respect to the catheter body 102. For example, different magnetic fields can be applied to the magnetic tip 104 to cause the magnetic tip 104 to move within a full range of motion defined by the ball 2304 and the ball connector portions 2312(a), 2312(b). The external magnetic field can be supplied in any of the manners described herein. It will be appreciated that the magnetic tip 104 can also simply rotate about the longitudinal axis 101 described herein.

[0214] FIGS. 23A, 23C, 23H, 23I, 23J, 23K, and 23L illustrate the magnetic tip 104 aligned with the longitudinal axis 101. In this position, the magnetic tip 104 can rotate about the longitudinal axis 101 (e.g., defined by the guidewire 300 and the catheter body 102).

[0215] FIGS. 23B, 23E, 23F. and 23G illustrate the magnetic tip 104 placed at an orbital position by the external magnetic fields described herein. In some examples, the magnetic tip 104 can rotate about an orbital axis defined by the orbital rotation angle, as described herein.

[0216] It will be appreciated that the catheter 100 of FIGS. 23A-24G can be operable to provide the same functions (e.g., fluid delivery, fluid stirring, occlusion grinding, and / or aspiration) described with respect to other variations of the catheter 100 described herein. The catheter 100 of FIGS. 23A-24G can include any of the magnetic materials, surfaces, lumens, components, or system features described herein.

[0217] The orbital motion of the magnetic tip assembly can allow for increased access to difficult to reach occlusions. For example, by allowing orbital motion of the magnetic tip assembly, the catheter 100 described herein overcomes the limitations of previous catheters by allowing specific control over fluid delivery, aspiration, and grinding of occlusions. By controlling the magnetic tip 104 via externally applied magnetic fields, the size of the catheter 100 is significantly reduced (e.g., no mechanical or electrical actuation devices within the catheter 100 are necessary).

[0218] While numerous different configurations and embodiments of the catheter 100 are described herein. It will be appreciated that any combination of the various43105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center features described herein can be included or excluded from a catheter 100 dependent on the required functionality of the catheter 100.

[0219] In some examples, the magnetic tip 104 can be operable to grab hold of the occlusion 92 (e.g., capture and / or secure the occlusion 92). For example, the magnetic tip 104 can be operable to entangle the occlusion 92 (e.g., the magnetic tip 104 can hold and / or secure the occlusion 92). As the magnetic tip 104 rotates with the clot entangled, thrombolytics can be delivered around the occlusion 92 by any manner described herein. In this manner, the occlusion 92 can be broken down by the thrombolytic as the magnetic tip 104 rotates the secured occlusion 92. In some examples, securing the occlusion and spinning the occlusion while secured by the magnetic tip 104 aids in delivering the thrombolytic to the occlusion by increasing the surface area of the occlusion in contact with the thrombolytic and / or other therapeutic agent. For example, securing the occlusion and delivering the thrombolytic can accelerate the breakdown of the occlusion by the thrombolytic. By breaking down the occlusion secured by the magnetic tip 104, blood flow can be restored while the occlusion 92 is being broken down by the thrombolytic. In some examples, the magnetic tip 104 can be a net (e.g., mesh structure) operable to secure the occlusion 92.

[0220] In some examples, the magnetic tip 104 can be formed of a magnetic material. In some examples, the magnetic tip 104 can include platinum cobalt (PtCo), samarium cobalt (SmCo), neodymium iron boron (NdBFe), and / or bonded magnets.

[0221] In some examples, the catheter 100 can include one or more imaging materials. The one or more imaging materials can allow for imaging of the catheter. For example, the one or more imaging materials can be operable to be imaged with an X-ray machine, MRI, or other imaging system. In some examples, the one or more imaging materials include one or more radiopaque materials. In some examples, the one or more radiopaque materials can be operable to be imaged by an X-ray machine to provide a location of the catheter 100. In some examples, the one or more radiopaque materials allow visualization of the catheter 100 and / or visualization of the rotation of the magnetic tip 104 within the patient.44105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0222] In some examples, the magnetic tip 104 can include a radiopaque material. In some examples, at least a portion of the magnetic tip 104 includes a radiopaque material. In some examples, the magnetic tip 104 can include a ribboned radiopaque material running a length of the magnetic tip. In some examples, the ribboned radiopaque material is an angled ribboned ribbon radiopaque material. In some examples, the magnetic tip 104 can include a radiopaque material that covers half of a circumferential surface of the magnetic tip 104. When the external magnet drives the magnetic tip 104 at a speed that does not match a frame rate of an imaging system (e.g., fluoroscopy system), the angled ribbon radiopaque material and / or half coverage radiopaque material can allow visualization of magnetic tip 104 rotation under a fluoro cine series and / or live fluoroscopy.

[0223] In some examples, a distal tip of the magnetic tip 104 can include a radiopaque material and a body of the magnetic tip 104 can include a radiotranslucent material. In some examples, the catheter body 102 can include one or more radiopaque materials. In some examples, one or more proximal connectors of the catheter body 102 (e.g., connectors on a proximal edge or a proximal area of a circumferential surface of the catheter body 102) can include a radiopaque material. In some examples, when the one or more proximal connectors of the catheter body 102 and a distal tip of the magnetic tip 104 include radiopaque materials, a fixed distance can be maintained between the one or more proximal connectors and the tip of the magnetic tip 104, thereby provided precise location information when X-ray images of the catheter 100 are taken.

[0224] In some examples, the system can include the imaging machine (e.g., X- ray, MRI, or other imaging machine) described herein. In some examples, the system can further include a fluoroscope for imaging the radiopaque material.

[0225] In some examples, the catheter 100 can include a speed sensor. In some examples, the speed sensor is operable to determine a rotation speed (e.g., rotation rate) of the magnetic tip 104. In some examples, the speed sensor is disposed on or near the spindle 106 and / or the magnetic tip 104. The speed sensor can be any sensor configured to measure a rotation speed (e.g., rotation rate) of the magnetic tip 104 and / or spindle 106.45105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0226] FIG. 7C illustrates a magnetic guidewire 300 in one example. The magnetic guidewire 300 can be operable to guide the catheter 100 to a location of the occlusion. In some examples, the magnetic guidewire 300 can be navigated through blood vessels, veins, cavities, and arteries by the external magnet described herein or a different external magnet. The magnetic guidewire 300 can be received into the one or more lumens of the catheter 100. Once the magnetic guidewire is properly located in the blood vessel, vein, or artery (e.g., abutting or through the occlusion to be treated), the catheter 100 can be navigated along the guidewire to the occlusion.

[0227] In some examples, the magnetic guidewire 300 can include a magnetic material. In some examples, the magnetic material includes PtCo, SmCo, NdBFe, and / or bonded magnets. In some examples, as illustrated in FIG. 7C, the magnetic guidewire can include a distal magnet in gold, a welded joint, and a proximal support coil. In some examples, the magnetic material of the guidewire increases a total magnetic mass of the catheter 100 (e.g., including the magnetic tip 104), thereby improving a maximum degree of deflection of the catheter and / or decreasing a strength of the magnetic field necessary to deflect the catheter.

[0228] Although magnetic guidewires are described herein, it will be appreciated that other types of guidewires can be used with the system. Further, in some examples, the system does not include a guidewire.

[0229] The system described herein can further include an external magnet operable to generate a magnetic field. In some examples, the external magnet can be operable to position the guidewire, position the catheter 100 along the guidewire, and rotate the magnetic tip 104 of the catheter 100. FIGS. 8A-8C illustrate the external magnet 400 in one example. In some examples, the external magnet 400 can include an axle 402. The axle 402 can be attached to a pulley 404 which can be coupled to a motor 406, as illustrated, for example, in FIG. 8B. In this manner, the motor 406 can rotate the pulley 404, thereby rotating the axle 402 which causes the external magnet 400 to rotate. In some examples, as illustrated in FIG. 8C, the external magnet 400 can be attached to a robotic arm 408. The robotic arm 408 can include a motor and other components operable46105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center to rotate the external magnet 400. In some examples, the robotic arm 408 can be operable to locate the external magnet 400 in three dimensions.

[0230] The external magnet 400 can be operable to generate an external magnetic field. In some examples, the external magnetic field is operable position the magnetic guidewire 300 (e.g., by providing a magnetic force to the magnetic guidewire 300), position the catheter 100 along the guidewire (e.g., by providing a magnetic force to the magnetic tip 104), and rotate the magnetic tip 104 (e.g., by providing magnetic torque to the magnetic tip 104). In some examples, the external magnet 400 is operable to selectively rotate the magnetic tip 104 and / or selectively control a movement of the catheter 100 (e.g., via a magnetic force on the magnetic tip 104).

[0231] In some examples, rotating the external magnet 400 generates a corresponding rotation rate for the magnetic tip 104. In some examples, the magnetic field generated by the external magnet 400 generates a rotation rate for the magnetic tip 104. In some examples, the rotation rate of the magnetic tip 104 is about 60 rpm to about 2,000 rpm. In some examples, the rotation rate of the magnetic tip 104 can be about 1 ,000 rpm to about 2,000 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 200 rpm to about 2,000 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 200 rpm to about 500 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 1 ,100 rpm to about 1 ,300 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 1 ,200 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 100 rpm to about 500 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 100 rpm to about 300 rpm. In some examples, the rotation rate of the magnetic tip 104 is about 200 rpm. In some examples, the rotation rate of the magnetic tip 104 depends on the type of procedure (e.g., type and location of the occlusion) to be performed. For example, in thrombectomies the rotation rate of the magnetic tip 104 can be about 100 rpm to about 300 rpm, or about 200 rpm. In atherectomies, the rotation rate of the magnetic tip 104 can be about 1 ,100 rpm to about 1 ,300 rpm, or about 1 ,200 rpm.47105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0232] In some examples, the magnetic tip 104 has a rotational motion, rotary motion, orbital motion, erratic motion, or other type of motion from supplied magnetic field from the external magnet 400.

[0233] In some examples, the rotation of the magnetic tip 104 stabilizes at the rotation rate. In some examples, an applied torque on the magnetic tip 104 corresponds to a distance between the magnetic tip 104 and the external magnet 400. For example, moving the external magnet 400 closer to the magnetic tip 104 can increase the applied magnetic torque on the magnetic tip 104. Moving the external magnet 400 further away from the magnetic tip 104 can decrease the applied magnetic torque on the magnetic tip 104. The adjustable magnetic torque applied to the magnetic tip 104 can prevent perforations by ensuring the magnetic torque applied to the magnetic tip 104 is within a safe range.

[0234] In some examples, the magnetic field generated by the external magnet 400 is 50 mT or less. In some examples, the magnetic field generated by the external magnet 400 is about 5 mT to about 10 mT, about 10 mT to about 15 mT, about 15 mT to about 20 mT, about 20 mT to about 25 mT, about 25 mT to about 30 mT, about 30 mT to about 35 mT, about 35 mT to about 40 mT, about 40 mT to about 45 mT, about 45 mT to about 50 mT, or more. In some examples, the magnetic field generated by the external magnet 400 is less than about 30 mT.

[0235] In some examples, the external magnet 400 can provide an off-axis magnetic force / torque to the magnetic tip, thereby causing an orbital and / or erratic motion which can aid in grinding of the occlusion and / or mixing of a fluid delivered to the occlusion. In some examples, the orbital motion can allow the magnetic tip 104 to breakdown, debulk, and / or clear a larger volume occlusion than a non-orbital device. In some examples, the erratic motion can allow the magnetic tip 104 to break down, debulk, and / or clear a larger volume occlusion than a non-erratic device.

[0236] In some examples, the external magnet 400 can have a shape. In some examples, the shape of the external magnet 400 can be cylindrical, octagonal, or another shape. In some examples, the external magnet 400 can comprise a high magnetic energy48105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center material. In some examples, the high magnetic energy material can be NdBFe or other high magnetic energy materials.

[0237] In some examples, the external magnet 400 can have a mass. In some examples, the external magnet 400 has a mass of about 10 kg to about 30 kg. In some examples, the external magnet 400 can have a mass of about 10 kg to about 15 kg, about 15 kg to about 20 kg, about 20 kg to about 25 kg, about 25 kg to about 30 kg, or more.

[0238] In some examples, the external magnet 400 can include an electromagnet. In some examples, the electromagnet can generate temporal magnetic fields.

[0239] FIG. 22 illustrates another example of an external magnet system 700. In some examples, the external magnet system 700 can include a robotic arm operable to locate and rotate the external magnet 400. For example, the external magnet system 700 can include a plurality of robotic arm portions 702, 704, 706, 708, 710, 712 operable to locate the external magnet 400 in a desired position. Each robotic arm portion 702, 704, 706, 708, 710, 712 can be operable to move and / or rotate such that the desired magnetic field is generated by the external magnet 400, as described herein.

[0240] In some examples, the system can further include a 3D localization system (e.g., 3D localization subsystem). In some examples, the 3D localization system can include a robotic arm. In some examples, the 3D localization system is a magnetic 3D localization system. In some examples, the 3D localization system uses AC and / or DC magnetic fields. In some examples, the 3D localization system is operable to locate the catheter 100 and magnetic tip 104 within 1 mm of accuracy. In some examples, the 3D localization includes a localization pad. In some examples, the 3D localization pad is radiotranslucent. In some examples, the 3D localization pad is operable to be installed under a patient table. In some examples, the 3D localization system is operable to generate a localization field over the occlusion site and surrounding blood vessels, cavities, arteries, and veins of the patient. In some examples, the 3D localization system includes one or more localization coils operable to generate the localization field. In some examples, the one or more localization coils have a diameter of less than 0.3 mm. In some examples, the 3D localization system is operable to update a position of the magnetic tip 104 in real-time within an accuracy threshold of about 1 mm. In some49105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center examples, the 3D localization system is not affected by biological impendence or susceptibility.

[0241] In some examples, the catheter 100 can include one or more 3D localization sensors. In some examples, the one or more 3D localization sensors can include at least five degrees of freedom. In some examples, the one or more 3D localization sensors can be operable to provide a real-time angulation and / or a real-time position of the magnetic tip 104.

[0242] Further provided herein is a method for breaking down or removing an occlusion in a blood vessel, artery, cavity, or vein of a patient. The method can use any of the systems, devices, and components described herein and corresponding functions of the systems, devices, and methods described herein. FIG. 16 illustrates an example method 1700.

[0243] At step 1702, the method 1700 can include navigating a catheter comprising a rotatable magnetic tip to an occlusion. The catheter can be any of the catheters described herein. In some examples, navigating the catheter to the occlusion can include receiving a guidewire in a lumen of the catheter and moving the catheter along the guidewire. In some examples, an external magnet can be used to move the catheter along the guidewire. In other examples, navigating the catheter to the occlusion can be accomplished without the use of a guidewire. For example, an external magnet can be operable to navigate the catheter to the occlusion without the use of a guidewire.

[0244] At step 1704, the method 1700 can include providing, via an external magnet, a magnetic field operable to rotate the magnetic tip. Any of the external magnets described herein can be used to rotate the magnetic tip at any of the rotation rates described herein.

[0245] At step 1706, the method 1700 can include breaking down and / or clearing the occlusion by grinding the occlusion with the rotating magnetic tip. The rotating magnetic tip can have any of the properties described herein for breaking down and / or clearing the occlusion.

[0246] In some examples, the method 1700 can further include providing one or more diagnostic and / or therapeutic agents to the occlusion via a fluid delivery lumen of50105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center the catheter. The one or more diagnostic and / or therapeutic agents can be any of the diagnostic and / or therapeutic agents described herein.

[0247] In some examples, the method 1700 can further include providing aspiration to an occlusion site of the occlusion by providing a vacuum pressure through an aspiration lumen of the catheter. The vacuum pressure can be provided via any of the vacuum pressure mechanisms described herein (e.g., via rotation of the magnetic tip and / or via a vacuum pressure source).

[0248] In some examples, the method 1700 can further include locating a position and / or angulation of the catheter in real-time. Locating the position and / or angulation of the catheter in real-time can include any of the localization systems, assemblies, or components described herein.ExamplesExample 1 :

[0249] Cardiovascular disease is the leading cause of death, with coronary heart disease and myocardial infarction resulting in nearly 400,000 deaths in the US each year. For over 30 years, rotational and orbital atherectomy have been successful in enabling stent deliverability in severely calcified coronary lesions; however, the unique capabilities of these valuable tools have not evolved due to fundamental mechanical limitations, which include obtaining access within tortuous vasculature, adverse heating, arterial perforation, and generation of embolic debris. To improve vascular access and safety, a preclinical magnetic atherectomy system was developed.

[0250] Cardiovascular disease (CVD) is the leading cause of mortality in the United States (US), resulting in 850,000 annual deaths, of which nearly 400,000 are associated with coronary heart disease (CHD) and myocardial infarction (Ml). By 2030, global annual deaths will exceed 20 million. More than 90 million US adults currently live with CVD, which is associated with an annual economic burden of more than $330 billion. Together, Ml and CHD are the most expensive conditions treated in US hospitals, totaling more than $20 billion each year, with costs expected to double by 2030. Percutaneous coronary intervention (PCI) is an effective strategy to restore blood flow for obstructive CHD.51105119194.4PATENTAttorney Docket No. 104954-835903Via Patent CenterHowever, while nearly 950,000 PCI procedures are performed each year in the US, navigating tortuous vessels is challenging and enabling stent expansion within severely calcified occlusions often fails, which are observed in ~35% and ~20% of procedures, respectively.

[0251] Rotational atherectomy (RA) and orbital atherectomy (OA) are increasingly used to debulk otherwise unbeatable lesions to enable PCI, with recent studies confirming RA and OA improve stent deliverability vs. standard PCI without negatively affecting outcomes. To debulk severely calcified lesion, RA / OA devices employ long (>300cm) stiff driveshafts which spin burs / crowns at speeds up to 180,000 RPM. For both RA and OA, the inflexible driveshaft often hinders access within tortuous vasculature. The high speeds employed are necessary to stabilize the bur / crown about a guidewire, without which, the tip would dangerously whip. However, the need for extreme rotational speeds greatly increases the complexity of RA / OA systems and presents risks, which include 1 ) thermal injury due to driveshaft friction, 2) arterial abrasion and perforation, 3) guidewire shattering, 4) bur / crown entrapment, and 5) embolic debris within the distal vasculature. To reduce the risk of traumatic injury, RA and OA devices cannot be used for more than five minutes.

[0252] A magnetic rotational atherectomy platform has been developed that includes an over-the-wire atherectomy device that is controlled using magnetic fields 100X weaker than an MRI. Applying magnetic forces directly to the bur eliminates the need for 100X higher driveshaft speeds to stabilize tip rotation. Resultingly, safer and more efficacious debulking is achieved. As confirmed by testing, magnetic grinding at 1200RPM produced smaller debris without any thermal heating, in contrast to RA and OA devices which require >100,000RPM. The current prototype magnet system was enclosed in a protective shroud and mounted on a portable multi-axis robotic arm, and the current prototype atherectomy catheter enables selective profile grinding and 3D localization. Following professional in vitro efficacy assessments, large animal safety and feasibility comparative studies can be conducted.

[0253] Coronary heart disease (CHD) is a leading cause of death in the United States (US), resulting in nearly 400k annual US deaths largely due to myocardial52105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center infarction (Ml), with costs totaling more than $20B each year. Percutaneous coronary intervention (PCI) is an effective treatment for obstructive CHD when acute risks are present. Enabling stent expansion within chronic total occlusions (CTOs) often fails unless rotational atherectomy (RA) or orbital atherectomy (OA) is employed. RA / OA use stiff driveshafts to spin burs / crowns at speeds up to 180,000 RPM. Without high speeds and stiff stabilizing shafts, the burs / crowns can dangerously whip. However, these high speeds present several risks, which include thermal injury, arterial perforation, guidewire fragmentation, bur / crown entrapment, and embolic debris in the distal vasculature. A functional shaftless magnetic atherectomy device has been developed. A high degree of control over the magnetic bur is achieved by magnetic coupling bur rotation with that of a compact external magnet, where the bur design and abrasive coating are optimized for lower-speed grinding (<2,000 RPM).

[0254] A ~15kg NdBFe rotational atherectomy magnet system generating 15mT at ~30cm from the surface was successfully built and x-ray suite compatibility assessments completed. Prototype 00.014in magnetic guidewires and over-the-wire magnetic atherectomy bur assemblies (e.g., 01 mm and 3mm length) were successfully built. Magnetic guidewires were successfully navigated within complex cardiac vasculature phantoms. Magnetic bur stability was achieved using 1 ,200 RPM (100X lower vs. RA / OA). In vitro CTO access and debulking studies were conducted, which confirmed the magnetic burs generated smaller embolic debris without any heating. In contrast to a ~5min runtime limit for RA / OA devices, magnetic burs could be safely active for >1 hr. Importantly, magnetic burs enabled preferential grinding to minimize vessel trauma, which is highly valuable and is not possible with commercial devices. Lastly, a compatible 3D localization system was integrated into catheters to enable real-time tracking.

[0255] Having developed effective bur sizes, shapes, and coatings, the prototype magnetic atherectomy catheter bur can be operable to enable selective surface grinding. Advanced magnetic material development and assessment can be conducted. 3D localization can be integrated to provide real-time feedback on bur position and angulation using a 5 DoF (degrees of freedom) sensor which already has been shown to be53105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center magnetically compatible. Mechanics can be assessed up to ~12,000RPM, which is 10X higher than anticipated use. Magnetic control of rotating bur angulation can be assessed.

[0256] Prototype magnet system controllers and mechanics can be improved so that motions are contained within a safety shroud, which can be attached to a multi-axis robotic arm. ~10X magnet rotation speeds (~12,000RPM) can be assessed. Final mechanical and magnetic safety assessments can be made. Software can be developed to enable selective grinding to be specified.

[0257] Preclinical magnetic atherectomy device navigation, 3D localization, and tip angulation can be assessed using cardiac vasculature phantoms. Comparisons can be made to commercial RA and OA devices. For in vitro CTO crossing and debulking studies, assessments can be conducted. Magnetic atherectomy control parameters (e.g., speed, magnetic field) can be optimized. Bur grinding pattern, forces on vessel wall, embolic debris, and heating can be compared to commercial RA and OA devices.

[0258] A large animal (pig) in vivo study can be conducted to assess preclinical magnetic rotational atherectomy system safety and feasibility. Magnetic atherectomy devices can be endovascularly navigated and activated within CTO-associated vessel segments (e.g., RCA, PIV, LCA). Vessel histopathology can assess induced injury (i.e. , edema, perforation, heating). Workflow feasibility and 3D localization can be assessed. Comparisons can be made to RA and OA devices.

[0259] With a prevalence of -128M and ~930k annual deaths, cardiovascular disease (CVD) is the leading cause of death in the US with an annual US economic burden of $422B.1 By 2035, worldwide deaths will exceed 20M and costs will exceed $740B.2 Coronary heart disease (CHD) has the largest annual US mortality (370k), driven by myocardial infarction (Ml). CHD’s prevalence in the US is 30M.6 Ml and CHD costs total $20B each year in the US, with costs more than doubling between 2015 and 2035.

[0260] CHD-associated chronic total occlusions (CTOs) are complete or nearcomplete occlusions of a coronary artery (TIMI flow of 0-1 ). CTOs typically possess dense collagen-rich fibrous caps at both ends and a columnar lesion of calcified, resistant fibrous tissue surrounding a softer core of organized thrombus and lipids. Dense fibrous tissue with fibrocalcific regions are common. Common CTO locations are the left anterior54105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center descending (LAD), right coronary artery (RCA), and left circumflex artery (LCA) segments. Data shows CTO prevalence is observed in nearly 50% of diagnostic angiography patients. Being relatively asymptomatic, CTO’s true prevalence in the US could be as high as 16M.

[0261] For stable CHD, medical management is first line standard therapy, which shows similar outcomes to percutaneous coronary intervention (PCI) in terms of death and hospitalization. Exercise and stress reduction are also beneficial. For unstable CHD, however, PCI better reduces CHD symptoms, Ml-associated ischemic damage, and risks of mortality and major adverse events. For PCI procedures, a guidewire is passed through the lesion and a balloon-inflated stent is deployed to restore blood flow, with many cardiac vessels being tortuous. With nearly one-million annual procedures, percutaneous coronary intervention (PCI) is increasingly employed to treat obstructive CHD when acute risks are present. However, PCI often fails to place stents within severely calcified lesions, evident in ~20% of all PCI cases. To enable stent deployment, atherectomy systems were developed to debulk otherwise untreatable lesions. Coronary atherectomy use tripled in the latter 2010s with >30k annual procedures currently performed in the US.

[0262] Atherectomy systems include directional coronary atherectomy (DCA), laser ablation, lithotripsy, rotational atherectomy (RA) and orbital atherectomy (OA). Of these, DCA was abandoned in the US due to risks related to the blades employed, and laser ablation is inefficient against calcified lesions. A lithotripsy system converts electrical into mechanical energy during balloon inflation to disrupt calcification, but lesion access is still not improved. In contrast, RA and OA enable stent deployment when standard PCI is not feasible, as backed by studies. Rotablator is the dominant atherectomy device, followed by the Diamondback 360 device. RA / OA devices rotate stiff driveshafts over stabilizing guidewires at high speeds, which limits their use within tortuous vessels. While RA uses a bur, OA uses a crown and debulks in an eccentric orbit. RA and OA are similar in terms of perforation rates, embolic debris, heat generation, and complexity; however, more deaths and injuries were reported to the FDA for OA. Both systems are similarly priced (~$40k), with OA devices costing 4X more ($3,800 vs. $900).55105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0263] Despite the success of RA and OA, safety concerns have limited broader adoption. First, because RA / OA driveshafts are stiff, use within tortuous vessels is difficult. Second, because ~100,000RPM speeds are needed to stabilize the bur / crown, arterial perforation and thermal injury are risks. And third, skilled interventionalists are needed to control devices while monitoring against guidewire whipping, bur / crown entrapment, arterial perforation, guidewire shattering, guidewire loops, and overheating. Due to these concerns, all RA / OA procedures are limited to 5 min. If atherectomy were improved so that 1 ) tortuous vessels were more easily accessed, 2) high bur / crown speeds were not needed, and 3) procedures were not limited to 5 min, increasing trends of atherectomy utilization would be accelerated.

[0264] A magnetic atherectomy catheter was invented (FIG. 1 ). Magnetic forces are applied only to the magnetic bur, so stability is achieved using low magnetic fields (<15mT) and 100X lower speeds, while providing similar RA / OA torques. Importantly, lower rotational speeds were shown not to increase embolic debris size. Because the bur’s kinetic energy is 10,000X lower, risks of whipping, perforation, burns, and bur / crown / guidewire shattering are reduced, so devices can be used >5 min. Bur rotation speed is stable ±30 deg planar tilts. Lacking a driveshaft, the more flexible catheter is easier to navigate and is less likely to tug the guidewire out of place. Importantly, there is no driveshaft heating, and the inner lumen is compatible with standard PCI and CTO crossing guidewires. A passive circuit near the bur can be used to detect stalls, and the low speeds employed enable smaller burs to be made than possible for RA / OA devices to access smaller vessels.

[0265] Second, a magnet console was invented to control magnetic atherectomy devices (FIGS. 8A-8B and 9). By solving the magnetic dipole equation, the magnet’s placement and orientation can be derived for a desired magnetic field. By automatically orientating the external magnet’s rotational plane, the same magnetic field (and time- averaged rotational field) can be applied to the device’s tip regardless of how the user repositions the magnet subassembly. Thus, the external magnet can be easily moved within clinical workflows without changing the magnetic bur’s orientation. To increase magnetic torque, the magnet can be simply moved radially closer. Unlike RA / OA torques56105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center which risk perforation and entrapment, the magnetic field acts as a clutch which safely limits the applied torque. Moreover, by tilting the rotating magnet appropriately, selective grinding can be applied to the CTO, thus overcoming the guidewire biasing grinding. For device / magnet localization, a magnetically compatible 3D localization system was integrated (<1 mm accuracy). The pad is radiotransparent, and the detection volume includes the entire cardiac vasculature. 3D localization sensors have been made as small as 00.3mm. The value of 3D localization is that precise positional real-time information is provided on device angulation and advancement without increasing ionizing radiation exposure.

[0266] Third, a magnetic guidewire was developed, whose tip can be deflected to better navigate tortuous vasculature using low (15-30mT) static magnetic fields. In a rotating magnetic field, the guidewire’s tip is stable for frequencies >300 RPM and generates negligible forces. Machining and assembly methods, and unique PtCo components were developed to improve magnetic control.

[0267] Magnetic atherectomy procedures are compatible with standard clinical workflows. In short, starting from the guide catheter’s placement in the coronary ostium, the clinician navigates a guidewire across the lesion. The flexible magnetic atherectomy catheter is advanced over the guidewire. If needed, guidewires are swapped with crossing versions via the catheter’s inner lumen. Once sufficiently debulked, the catheter is removed, and a stent-balloon system is advanced over the guidewire for deployment.

[0268] Implant (e.g., pacemaker, stimulator) magnetic compatibility up to 3.0T (MRI) has been previously shown (~200X stronger than proposed). The magnet’s EMF is 20X lower than the ~1 kHz nerve-stimulating threshold. For clinical use, standard MR mitigations can be followed (e.g., training and patient screening). Arterial injury is mitigated in that only <3g and <10mg are generated on the magnetic bur and guidewire, respectively (~15X and ~5000X smaller than endovascular device forces). In general, heart motion does not affect RA / OA devices. Likewise, heart motion cannot affect magnetic devices due to the heart wall’s ~1cm travel being contained within a mostly uniform magnetic field region (~01 Ocm). X-ray compatibility was shown, where digital x-57105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center ray systems are immune if <20mT is generated on the x-ray anode and the imaging plate’s power supplies, which is the case for the prototype magnet (<5mT generated).

[0269] The magnet console can be similar in size and cost to a portable ultrasound (~$30k), and device cost of good is <$150. In contrast, RA and OA consoles are ~$40k and devices range from $1000 (RA) to $4000 (OA).

[0270] U.S. Patent No. 11 ,957,848 and U.S. Patent Application No. 16 / 905,869 are incorporated herein by reference in their entirety.

[0271] For the magnet console, a prototype system was built using a transversely magnetized ~15kg NdBFe ~50MGOe magnet in a 3D printed safety covering (FIGS. 8A- 8B). Rotation speeds up to ~2000RPM were achieved. Structure components were nonmagnetic. Magnetic field strength along front and side axes were confirmed to be 15 mT (strong axis) at 25 cm from the magnet’s surface (FIG. 9). The maximum extent of the 5G line was 100 cm, which is well-within hospital magnetic field guidelines.

[0272] For the magnetic atherectomy catheter, proof-of-concept atherectomy devices (prolate spheroid and cylindrical) were built using transverse-magnetized NdBFe ~50MGOe material with diamond powder abrasive caps that can be active >5min without heating (FIGS. 7A-7B). Bur assemblies much smaller than commercial RA / OA devices were also built to as small as 01 mm. Using a rotational joint, ~02 mm bur subassemblies were mated with open-lumen catheters (~2 mm OD, 1 mm ID). Magnetic guidewire prototypes (0.014 in) using 50MGOe NdBFe material were successfully built (FIG. 7C). Guidewire magnets (00.012 in, 0.079 in length) replaced the platinum tips of commercial 0.014 in guidewires. Radiodense gold hypotubes were affixed to the magnets, which were laser welded to guidewire support coils. Unique PtCo magnetic alloys were developed to improve performance. Studies confirmed magnetic guidewires were responsive to 15-30 mT magnetic fields. Radiodensity testing confirmed similar opacity as a comparator Shinobi guidewire. Magnetic and non-magnetic 00.014” guidewires successfully passed through the shaft. Without use of a guidewire (which artificially stabilizes the bur), optimal bur stability was achieved at ~1 ,200RPM with ±35 degrees of controlled deflection possible (FIGS. 10A-10B). In vitro assessments were made (FIGS. 11A-11 C). Grinding was tested using standard calcified (Ultracal-30 powder) plaque discs. Magnetic bur58105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center torque forces measured -0.058N (1.5mm radius from center). Compared to RA / OA historical data, magnetic burs produced small debris (~20pm mean length) using 1200RPM with no heating (<1 °C, even after sustained use over —1 hr) and an effective low mean griding force of ~0.07N. For navigation, severely calcified lesions are seen in LAD (50%), RCA (26%), and LCA (12%) segments. Because bifurcation and ostial lesion locations are seen in 42% and 27% of cases, with tortuosity seen in -35%, CTO cardiac and tortuous phantoms were fabricated using 3D SLA printed in clear methacrylate and / or glass (FIG. 11 D). Unlike the commercial guidewire, the magnetic guidewire successfully navigated multiple complex turns (FIG. 11 E).

[0273] To improve tortuous vascular access and PCI-resistant lesion debulking, magnetic atherectomy catheter burs can reflect improved shapes which enable better selective CTO surface grinding. Existing diamond coatings can be compared to new coatings to reduce embolic debris size. Mechanical stability can be tested up to 10X speeds (e.g., 12kRPM).

[0274] Building on existing prototypes, preclinical magnetic atherectomy catheters with 5 DoF 3D localization sensors can be manufactured (FIG. 2). Prolate magnetic burs using ~50MGOe NdBFe magnetic material can be made as small as -01 mm (smaller than typical RA / OA sizes). A bore allows standard 0.014in guidewire passage. Having determined that diamond-powder abrasive caps perform well, material improvements can be studied, e.g. diamond powder distribution (dense >50, moderate -40, sparse <30 particles per 4.08e04pm2). Bur magnetic moments can be measured using VSM at the NHMFL. Custom -4F dual-lumen catheters (FIG. 2) can be mated to bur subassemblies. For stability and selective surface grinding studies, rotational magnetic fields up to ~12kRPM and device magnetic deflection rotation of up to ±40 deg can be assessed with and without use of coaxial guidewires. Burs can be reflectively marked to measure speed. Torque assessments can use the standard filament method: one end of a thin (diameter 150 pm) flexible copolymer filament is wound on the bur, the other end attached to a precision force gauge. Maximum torque occurs when magnetic field is applied at 90 deg from the bur’s magnetization.59105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0275] Five measurements per same-type device can be used. For NdBFe magnets, microscopy can assess structural integrity and dimensional accuracy (pass / fail criteria to within ±~5% tolerance). VSM can assess magnetic characteristics (pass / fail criteria, magnetizations <~10deg from the main axis, within ~15% of the predicted magnetic moment). Changes to improve device magnet’s magnetic strength can be assessed for superiority (one-sided, p<0.05, 80% power). To assess radiopacity, commercial comparator devices can be used. For atherectomy catheter magnetic deflection, magnetic plane tilt and rotation speed can be measured for each device (rotational speed a variable) using a high-speed camera. For rotation speed, bur and console magnets can be compared (two-sided, p<0.05, 80% power). For torque assessments, maximum torques can be compared to magnetic calculations (standard regression analysis). For radiopacity, fluoroscopy comparisons can be made against RA / OA devices using the aluminum equivalence standard.

[0276] Magnet bore holes may require electrical discharge machining. SQUID, TEM, and SEM imaging may be used. Other abrasive caps may be explored (e.g., diamond exposure depth). Passive coil windings may be placed at the bur to detect stalls. Other bur speeds, sizes, and magnetic materials (e.g., PtCo) may be used. Beating heart phantoms may be used to assess heart motion impact.

[0277] The prototype magnet requires modifications to ensure safe use for large animal studies. For this, control electronics and mechanics need to be reconfigured so that the exiting ~15kg magnet can be placed in a protective “pod” that can be attached to multi-axis robotic arms.

[0278] For the magnet system (FIG. 12), the prototype system can be improved in preparation for large animal studies. The motor system can achieve a 10X maximum speed ~12kRPM. For speed measurements, a reflective marker is attached to optically measure rotation frequency. The magnet subassembly is placed in a mountable pod structure which encapsulates all articulations to mitigate mechanical and projectile risks.

[0279] For robotic arm attachment, robotic arms (UR16e or UR20) are used which are 6-axis, TUV-certified robots with integrated joint force and torque sensing. UR arms support hand-guided operation and are rated for sanitary environments. Magnetic60105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center compatibility has already been confirmed for both arms. Control software with a graphical user interface (GUI) controls the frequency and direction of rotational magnetic fields (for CTO selective debulking). To assess control for selective grinding, a worst-case profile phantom (95th percentile per anthropometry software) is used with a magnetometer placed at clinically relevant navigation points and CTO locations. Rotation axis can be directed in 14 field directions (6 cardinal + 8 trisector, ~15mT time-averaged). Magnetic fields rotational frequencies can be confirmed. 3D localization accuracy has already been confirmed; however, assessments can be repeated to confirm proper positional and angulation reporting. For human factors, bumps / pulls, pod positioning, and ~20 deg of cranial / caudal c-arm motion is qualitatively assessed.

[0280] Five measurements of the magnet’s magnetic field (static and temporal) can be taken. For rotation speed control, five measurements can be compared to target values. Rotation can be evaluated up to 12kRPM in 1 kRPM steps. Methods can be repeated to assess improvements (one-sided, p<0.05, 80% power). Accuracy and precision of 3D localization in a rotating field can be tested by taking 30 sensor readings (two-sided, p<0.05, 80% power) with the rotating axis directed toward 14 field directions (cardinal + trisector).

[0281] Counterweights are used to prevent tipping. An emergency stop may be included with smooth braking. Battery operation may be reflected. Stability can be confirmed for lower rotational speeds prior to advancing to higher frequencies. Employed magnetic fields are likely safe which are 20X lower than biological and implant interaction thresholds. Interference with digital angiography is unlikely in that the generated EMF is less than 1 pV. Prior integration efforts confirmed x-ray system compatibility. Magnetic shielding may be employed.

[0282] Magnetic navigation using static magnetic fields was completed. Improved bur assemblies can be evaluated to define best bur and magnetic parameters. Professional in vitro evaluation can be performed.

[0283] To assess preclinical magnetic atherectomy catheter improvements, a grinding forces, emboli generation, and heating are assessed. To assess CTO debulking, a published calcified cap CTO model can be used. Briefly, caps are composed of CaSO461105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center and gelatin (~75wt% CaSO4, ~5wt% gelatin, ~20wt% H2O), measure ~10 mm in diameter (~10 mm thickness), require ~15g penetration force, and include an integrated thermocouple and a hole (~0.5 mm diameter) for guidewire passage. Phantoms can be used within 24hrs. Caps can be placed in ~10 mm diameter tubes, guidewires extended ~30 mm (per RA / OA IFUs), and ~4CP glycerol introduced. A precision force sensor behind the cap can monitor forces. For commercial comparisons, recommended RA / OA sizes and speeds can be used [Rotablator (1.5mm bur, 164kRPM), Diamondback 360 (1.25mm crown, 80kRPM)]. For magnetic atherectomy catheters, parameters can be chosen to assess CTO debulking and embolic debris size (up to ~2kRPM and ~30mT). RA / OA devices can be run for 5 min (max. RA / OA time). Magnetic devices can be run from 5 min to ~15 min. High-speed cameras can record griding. The thermocouple and a spot IR sensor focused on the bur (e.g., Calex PC21 LT-0) can measure temperature. Thermal images can be taken every 60 seconds. Post studies, vessel constituents can be reserved for particle sizing (e.g., Malvern S2000 Mastersizer), and debulking depth measured. For in vitro RA / OA grinding comparisons, a plaque lesion phantom (FIG. 13, bovine femoral bone) inside a test chamber replicates Young’s moduli for vessel and muscle (45kPa and 8kPa). Atherectomy devices can be moved back and forth over guidewires (~10mm / s, 60s total) in the lesion. Blood flow is simulated (30mL / min, 37 degrees C simulates, ~4CP). Cameras record grinding (18,000 frames / sec). A thermocouple is set in the bone. A piezoelectric dynamometer below the lesion monitors radial forces. Assessments include grinding axial / radial displacement, grinding forces, and debris size distribution (Malvern S2000 Mastersizer). For selective grinding, a mark can be placed on the phantom, guidewires retracted past the bur joint (allowing free motion), magnetic rotation axis directed toward the mark, and the bur moved back and forth. Tests with extended guidewires and aligned rotation axis are controls. Phantoms can be imaged before and after grinding.

[0284] For studies, emboli <200pm are considered relatively safe. Grinding forces and displacements can be estimated from pixel intensities. Fluid dynamic models can derive pressure distributions and streamlines. FFT analysis can identify orbital and grinding correlations. FEM can estimate heat rise and transfer coefficients using a62105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center thermocouple. For emboli sizing, -10 measurements / sample can be made. SEM can assess lesion surface grinding morphology. Five runs per study per device type can be used. Superior emboli reduction (one-sided), noninferior debulking depth (two-sided), and lower (one-sided) adverse heating can be compared (ANOVA, 80% power, p<0.05) across RA, OA, and magnetic atherectomy devices. For selective grinding, orthogonal lines drawn on the images intersect the bore center, one through the mark. Selectivity score is the difference between hole widths along lines; test and control phantoms can be compared (80% power, p<0.05).

[0285] Other lesion phantoms may be considered. Devices may be reused after safety inspection. Other emboli sizing methods may be used. RA / OA historical data may be leveraged. Magnetic atherectomy times may be extended if no heating or device damage occurs.

[0286] Grinding using the magnetic atherectomy device shows safe heating (<5 degrees C temperature rise after 15min), small emboli (<~200pm mean debris, STD<~50pm), and selective grinding confirmation (p<0.05).

[0287] Preliminary in vivo feasibility and safety data is prerequisite to the technology’s development. Because a preferred animal model to assess CTO debulking with atherectomy device are not standard, atherectomy debulking efficacy is instead assessed using professional in vitro or ex vivo (i.e. , cadaver). Due to cadaver models being cost-prohibitive, these studies are deferred to a next phase proposal once safety and efficacy are demonstrated using the proposed large animal model, which is standard for assessing device navigation feasibility and safety given that pig coronary vasculature [(RCA, LCA, and posterior interventricular artery (P IV)] is similar to that of humans.

[0288] To assess safety and navigation, 6 pigs (equal sex distribution) can be used: 2 pigs (male / female) for each device type [magnetic, RA (Diamondback 360) and OA (Rotablator)]. Pigs can weigh ~40kg to reflect the recommended heart-to-body weight ratio for cardiovascular function. Pigs can be anesthetized and from standard femoral access, clinicians can advance catheters over a 0.035in J-tip guidewire into the ascending aorta. Fluoroscopy can confirm guide catheter placement in a coronary ostium. Atherectomy devices can advance over 0.014in guidewires into each coronary artery63105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center(RCA, PIV, LCA). Navigation success / failure and guidewire tracking time can be measured. For guidewire bias mitigation, magnetic devices can be steered toward opposing vessel walls. Fluoroscopy can confirm 3D localization (compared to 3D localization for magnetic devices). For safety endpoints, burs can be activated, and devices moved back and forth for 15 seconds in the selected target vessel subsegment. RA and OA devices can be used no longer than 5 min (max. RA / OA time). For magnetic devices, procedures may be extended to ~15 min if supported by AIM 3 results. Post studies, animals can be sacrificed, and coronary vasculature extracted for histology, and scored. For workflow feasibility, users can qualitatively identify safety, form, and function improvement opportunities for the clinical system.

[0289] For device navigation, studies are powered to detect effect sizes of 0.42 and 0.44 across device groups for absolute success and successful navigation times, respectively (ANOVA, 80% power, p<0.05). To assess arterial damage, the device can be used on three locations (distal, middle, and proximal) in three arteries (e.g., RCA, PIV, LCA), providing n=9 measurements per animal. Standard histopathological scoring (20- point scale) can be used. Altogether, there are 48 data points for histopathological assessments (6 animals, three vessels, three vessel locations), which enables 2 same vessel comparison and 16 total histopathological comparisons across magnetic, RA, and OA device groups. Although underpowered to detect sex differences, qualitative observations can inform the power of subsequent large animal studies. Taken together, histopathology is powered to detect 0.44 effect size (ANOVA, 80% power, p<0.05). For feasibility, comparisons are largely qualitative in nature and principally rely on investigator feedback, which can inform the methods of subsequent studies. Magnetic compatibility with the angiosuite uses pass / fail criteria regarding <20mT on the x-ray anode and power supplies and observed EMF effects (unlikely for low frequencies used).

[0290] Attending personnel can be trained per institutional x-ray and ferrous interaction safety protocols. Clinicians may change navigation targets and animal procedures. Animals may be replaced if baseline vitals or anatomies are abnormal. For magnetic operating room compatibility, small magnets and EMF sources may be placed64105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center near equipment to assess static, ferrous, and EMF interactions and image shift prior to conducting animal studies.Example 2:

[0291] Inaccessible blood clots within small distal neurovascular arteries often result in poorer acute ischemic stroke patient outcomes. In addition to forming naturally, small emboli are often a consequence of thrombectomy-generated debris. A novel image- guided endovascular magnetic thrombectomy system was developed to safely access and effectively remove otherwise untreatable distal emboli to improve stroke patient neurological outcomes.

[0292] Acute ischemic stroke (AIS) is due to an occlusion in the neurovasculature and is a leading cause of death and neurological disability in the United States (US). It is estimated that of nearly 700,000 annual AIS events, nearly half are within small distal cerebral vessels not amenable to thrombectomy. By 2030, AIS’s total economic burden is projected to exceed $180B in the US alone.

[0293] Early restoration of blood flow to the brain is critical to improve AIS patient outcomes. Although intravenous thrombolysis is beneficial, thrombolysis is underutilized due to its low efficacy and dose-dependent risk of symptomatic intracranial hemorrhage (sICH). Due to this risk, thrombolysis is generally not used for milder strokes, such as those associated with distal occlusions. In contrast to thrombolysis, thrombectomy is highly effective in recanalizing occluded proximal vessels; however, stent-retrieval and aspiration devices are too large to safely access distal emboli within small vessels. Furthermore, thrombectomy often generates embolic debris resulting in inaccessible secondary distal emboli. Although distal occlusions are known to result in poorer patient outcomes and more expensive hospitalizations, many physicians feel that attempting to mechanically remove distal emboli within small vessels presents safety risks. In an effort to improve patient outcomes, intraarterial thrombolytic administration post thrombectomy has been explored to lyse distal clots. However, thrombolytic agents are often diverted away from the occluded vessel due to the formation of natural stagnant blood columns proximal to distal clot. Even when high thrombolytic doses are administered directly within the occluded vessel, thrombolytic agent diffusion is slowed to a few millimeters per hour,65105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center resulting in little retained fibrinolytic activity by the time the thrombolytic reaches the clot. Taken together, distal neurovascular emboli are largely left untreated despite being known to result in poorer patient outcomes.

[0294] A novel over-the-wire (OTW) thrombectomy system was developed to remove primary and secondary distal occlusions not safely accessible using standard thrombectomy. The system uses a small portable magnet, is compatible with digital angiography and thrombectomy workflows, and can treat multiple distal occlusions. In partnership with national laboratories, proof of concept magnet systems, magnetic guidewires, and magnetic thrombectomy devices were built. Devices successfully navigated complex phantom vasculature. Professional bur assessments confirmed 1 ) safe operation up to ~2000RPM, 2) bur coating stability, 3) no heating, 4) <20 micrometer debris (calcified), 5) safe torques / forces, and 6) the ability to accommodate curved vessels. Lastly, a ~01 mm proof of concept magnetic bur assembly was built. For the proposed effort, a preclinical ~01 mm magnetic OTW distal thrombectomy device can be built and assessed that is compatible with standard neurovascular access devices. Following professional in vitro efficacy assessments, large animal studies can be conducted to assess safety, feasibility, and efficacy.

[0295] With nearly 700k annual events, AIS remains a leading cause of disability and death. Although thrombectomy is successful in removing larger proximal occlusions, smaller emboli are often inaccessible. Furthermore, thrombectomy procedures often generate embolic debris which result in distal vasculature occlusions which cannot be safely accessed. In both cases, these emboli are correlated to poorer AIS patient outcomes and longer hospital stays. Although intraarterial thrombolysis post thrombectomy has been explored to lyse distal emboli, efficacy is limited due to the natural formation of stagnant blood columns proximal occlusive clots. Because thrombolytic diffusion is slowed to a few millimeters per hour, little thrombolytic activity remains by the time the thrombolytic reaches the clot. Currently, most distal emboli are not treated.

[0296] Studies using CT-based AIS phantoms proved stagnant blood columns prevent thrombolytics from reaching distal clot. In partnership with national laboratories,66105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center prototype 00.014in magnetic guidewires, over-the-wire (OTW) ~02mm and ~03mm magnetic bur assemblies, and a 15kg magnet systems (15mT at ~30cm) were built. A stepper-motorized magnet system was used to navigate prototype magnetic guidewires and proof-of-concept thrombectomy catheters within complex phantom vasculature. A speed-controlled motorized system successfully achieved ~2000RPM. Bur grinding assessments were made. Using calcified disks and bur speeds of up to 1 ,200 RPM (~6X than anticipated use), it was found that 1 ) bur abrasive coatings were stable, 2) no heating occurred after an hour of sustained use, 3) calcium debris was smaller than 20 m, 4) applied torques and forces were within safe ranges, and 5) magnetic burs could be controlled to accommodate vessel curves. Lastly, a ~01 mm proof of concept magnetic bur assembly was built.

[0297] Stepper and speed-controlled motorized systems can be combined to articulate the current 14.7 kg magnet. Control components can be fitted within a safety shroud which can be attached to a multi-axis robotic arm. ~200RPM magnet rotation speeds can be assessed. Prior to conducting studies, mechanical and magnetic safety assessments can be made.

[0298] OTW magnetic burs (~01mm) can be built. Bur coatings can be used to assist clot clearance. The thrombectomy catheter’s lumen can deliver approved thrombolytics at the bur’s tip. Final preclinical thrombectomy devices can be manufactured. Standard radiodensity, mechanical, and magnetic properties can be assessed prior to studies.

[0299] Neurovascular phantoms based on AIS CTA / MRA datasets reflecting distal emboli can be 3D printed. Stagnant blood column lengths can be measured using dye. OTW magnetic thrombectomy device and manual and magnetic guidewires can be used to assess distal occlusions access. For in vitro embolic clot lysis studies using the magnetic thrombectomy catheter, published clot models can be used which reflect human whole blood, fibrinogen, and thrombin. FDA-approved thrombolytics can be used. Clot subtypes can also be assessed (e.g., fibrin-rich, platelet-rich, etc.). Control parameters can be optimized (e.g., bur rotational speed and magnetic torque, best thrombolytic and dose, etc.). Forces / torques on vessel wall, particulate size, and heating can be assessed.67105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0300] A known pig model can be used to assess access and lysis of occluded distal vessel using contrast-loaded clot. Stagnant blood columns proximal to the occlusion can be confirmed using contrast dye. Blood clots can be placed in left and right external carotid arteries (contralateral side is the naive control). Magnetic thrombectomy devices can be advanced over standard cerebral access guidewires to the clot and used in combination with an FDA-approved thrombolytic. Recanalization success, time to recanalization, procedural safety and feasibility can be assessed. Histopathology can compare vessel injury to naive clot on the contralateral side.

[0301] For procedures, a guidewire is navigated proximal to the clot prior to advancing the magnetic thrombectomy device to the clot. Although the magnetic thrombectomy device is compatible with standard neurovascular access guidewires, magnetically steerable guidewires have been developed to assist distal and tortuous clot access. A small thrombolytic dose is then administered from the device’s distal end as the magnetic bur is spun at a low speed. Magnetic bur induced pharmacodynamic mixing of the thrombolytic induces rapid clot dissolution. Post recanalization, residual debris can be accompanied by the thrombolytic which ensures distal clot debris is lysed. The bur also reflects a fine abrasive coating so that platelet-rich, calcified, and plasminogen- depleted distal emboli can be destroyed. In addition to magnetic guidewires, magnetic burs as small as ~01 mm and powder coatings have been prototyped. A portable magnet system was built which was attached to a Universal Robot multi-axis robotic arm. Preliminary phantom navigation and in vitro emboli dissolution studies have been completed.

[0302] Although the magnetic thrombectomy device is compatible with standard neurovascular access guidewires, magnetically steerable guidewires have been developed to help access distal and tortuous clot. A small thrombolytic dose is then administered from the device’s distal end as the magnetic bur is spun at a low speed. Magnetic bur induced pharmacomechanical mixing of the thrombolytic induces rapid clot dissolution. The bur also reflects a fine abrasive coating so that platelet-rich, calcified, and plasminogen-depleted distal emboli can be destroyed. In addition to magnetic guidewires, magnetic burs as small as ~01 mm and powder coatings have been68105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center prototyped. A portable magnet system was built which was attached to the company’s Universal Robot multi-axis robotic arm. Preliminary phantom navigation and in vitro emboli dissolution studies have been completed.

[0303] Acute ischemic stroke (AIS) is the result of a blood clot in a cerebral artery. Impacting more than 700,000 in the US each year, AIS is the leading US cause of longterm disability and the 5th leading cause of death. AIS events may be classified into three categories. First, ~35% of AIS events result in mild baseline deficit (e.g., NIHSS < 5). Although “mild”, ~60% experience poor outcomes and ~35% are not functionally independent after 90 days. Mild stroke is often associated with distal occlusions. Second, ~25% of AIS events are “wake-up” strokes, in which a stroke occurs during sleep, leaving 60% unable to independently ambulate after 90 days. And third, the remaining ~40% of AIS events comprise the treatment-eligible population.

[0304] Early reperfusion is critical to improve neurological outcomes, for which thrombolysis and thrombectomy are the current standards. Intravenous thrombolysis is approved within 4.5hrs of AIS onset. The only thrombolytic agent approved for AIS is Activase (alteplase / tPA, Genentech), which is associated with a ~30% improvement in 90-day neurological outcomes, albeit with a ~7X higher rate of symptomatic intracranial hemorrhage (sICH) (~7% vs. ~1 %). Alteplase cleaves plasminogen to form the proteolytic enzyme plasmin which lyses clot fibrin and leads to clot dissolution. Although thrombolysis improves neurological outcomes for mild and wake-up strokes, it is not generally used in these populations due to thrombolysis’ elevated sICH rate. In contrast, thrombectomy of proximal vessels is more effective than use of thrombolysis alone, where ~50% of AIS events are associated with thrombectomy-amenable occlusions. Thrombectomy achieves “good” outcomes (mRS 0-2) in ~40% of cases when used within 6hrs of AIS onset (and 24hrs in some cases).33, 34 However, performing thrombectomy within smaller distal vessels can pose serious risks despite primary distal occlusions accounting for ~40% of AIS events. Altogether, thrombectomy is employed in ~10% of all AIS events, which has steadily increased over the last decade.

[0305] A main risk of thrombectomy is the generation of clot debris, which obstructs distal vessels in 20% to 50% of cases. Studies show that both mechanical and aspiration69105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center thrombectomy generate thousands of clot fragments measuring between several hundred to several thousand microns in diameter, even with proximal flow control used as a mitigation. Secondary thrombectomy-generated distal occlusions limit reperfusion of the brain, resulting in longer hospital stays, poorer outcomes, and a higher sICH incidence compared to patients with better reperfusion. Taken together, most patients receiving thrombectomy are left moderately-to-severely disabled or die within 90 days, with only ~11 % fully recovering (i.e. , mRS=0 at 90 days).

[0306] Although thrombectomy is superior to intraarterial thrombolysis in recanalizing proximal vessels, locally administered thrombolytic agents can be effective in lysing distal occlusions not amenable for thrombectomy. Results of the PROACT-2 trial showed that 54% of those receiving prourokinase for primary M2 occlusions achieved partial or complete reperfusion (vs. 17% for those untreated), resulting in a 23% improvement in neurological outcomes (52% vs. 29%). Suarez et al. reported partial or complete recanalization using urokinase for 76% and 33% of M2 and M3 vessel occlusions, respectively. Recent efforts using intraarterial alteplase and tenecteplase for failed (and rescue) thrombectomy also showed improved 90-day outcomes. In general, local alteplase and tenecteplase doses of up to 22mg and 10mg appear safe, respectively, dosed at ~1 mg / min. However, intraarterial thrombolysis has limitations. First, accessing clot within distal tortuous vasculature presents safety risks. As guidewire tension accumulates along vascular bends, tip control becomes difficult and perforation or buckling can occur so that accessing the clot’s face becomes challenging. Second, distal occlusions form stagnant blood columns proximal to the clot which prevents thrombolytic agents from reaching the clot’s face. Instead, blood flow diverts most of the thrombolytic away from the occluded vessel. And third, thrombolytic agents within the stagnant column diffuse at a slow ~2mm / hr rate, during which time the thrombolytic agent’s concentration and activity are steadily reduced due to Fick’s Law of Diffusion and short thrombolytic half-lives (e g., ~5min to ~15min), respectively. As a result, distal emboli are generally left untreated despite being associated with substantially poorer patient outcomes.70105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0307] By 2030, there will be ~1 M annual AIS events in the US, with -40% associated with primary distal occlusions. Given a -$30,000 CMS reimbursement for thrombectomy (MS-DRG), the market opportunity associated with expanding thrombectomy to primary distal occlusions is ~$6.5B, not including indirect economic benefits due to improved clinical outcomes for removed secondary distal emboli.

[0308] A novel low-magnetic field navigation system has been developed that uses static magnetic fields to guide magnet guidewires to the clot.

[0309] Several innovations are reflected in the proposed technology. First, a novel low-magnetic field system was invented which uses 1 ) static magnetic fields to guide magnet guidewires and thrombectomy devices to the clot, and 2) rotational magnetic fields to operate the thrombectomy device. The workstation’s requirements were defined using anthropometry software. A cylindrical magnet is contained within the cover (i.e. , the “pod”). The pod is attached to a multi-axis robotic arm to accommodate bi-plane imaging without restricting patient access. To navigate devices, the magnet is oriented in three dimensions to maximize the magnetic torque applied to the magnetic guidewire or thrombectomy device. To relate the magnet’s position to c-arm isocenter, the workstation is attached to floor anchors whose locations are known relative to the c-arm’s isocenter. The pod is intended to be manually positioned which removes the need for an independent collision detection system and / or motion control integration with the c-arm. When the pod is moved to improve imaging or access, the magnet automatically reorients so that the applied torque is in the same direction. Device positional data can be obtained from x-ray imaging. Because the external magnetic field is relatively broad, device position is only needed to within ±5cm. To operate the magnetic bur, the magnet is spun (-200RPM). For use of both static and rotational magnetic fields, algorithms are used in ordering the magnet to ensure the pod can be moved within clinical workflows without changing the magnetic bur’s orientation (either when still or rotating). To increase magnetic torque, the magnet is simply moved radially closer. Importantly, the applied magnetic field acts as a clutch which safely limits the applied torque. By leading the bur with the magnet, an axial force is applied to the bur which safely limits the applied force. These safety aspects are not possible with FDA approved thrombectomy devices. Lastly,71105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center the spinning bur can be angled during clot engagement to accommodate vessel curves and bifurcations. Because <20mT is generated on the c-arm’s electron-beam anode and plate power supplies, the system is compatible with digital angiography suites (these safe thresholds were confirmed in prior Siemens and Philips integration efforts). Expensive room shielding is not required due to the 5-gauss line being contained within 80cm. For device / magnet localization, a magnetically compatible 3D localization system was integrated (<1 mm accuracy). The pad is radiotransparent, and the detection volume includes the entire neurovasculature. 3D localization sensors have been made as small as 00.3mm. Thus, precise real-time device positional information can be provided without increasing ionizing radiation exposure.

[0310] Second, a magnetic thrombectomy device was invented (FIG. 1 ) which uses low magnetic fields (>100X weaker than an MRI) to safely spin a magnetic bur. As an over the wire (OTW) device, the tool can be passed over existing neurovascular access guidewires as is standard for FDA approved AIS stentrievers and aspiration devices. If desired by the physician, the guidewire can be stopped proximal to the clot prior to advancing the bur beyond the guidewire’s tip to engage the clot’s face. A small thrombolytic dose (<0.1X of approved FDA dose) is administered at the rotating bur to rapidly and more thoroughly lyse the clot. This “pharmacomechanical” method has been proven to rapidly lyse large clot volumes. The most well-known such device is AngioJet by Boston Scientific, which operates using operates using the Venturi-Bernoulli effect and is used in upper and lower extremity peripheral arteries and veins that are >3 mm diameter. Upon recanalization, any remaining debris will be accompanied with the thrombolytic agent so that potential all clot debris is lysed. Because clots may possess non-lyseable materials (e.g., platelets, calcium, etc.), the device’s blunted tip possesses a powder abrasive coating which helps process the clot into microscopic fragments too regardless of composition. The proposed thrombectomy has key advantages over traditional mechanical rotational atherectomy (RA) devices, which includes orbital atherectomy. Main limitations of RA largely pertain to the need for >100,000 RPM speeds which are needed to stabilize the bur’s stiff driveshaft and prevent whipping. These include the following: stiff devices are unable to access complex vasculatures; driveshaft72105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center friction risks thermal injury; arterial abrasion and perforation; guidewire / bur shattering; bur entrapment; and embolic debris. For these reasons, procedures are limited to five minutes. In contrast, the proposed thrombectomy device overcomes these limitations. Because the magnetic bur’s kinetic energy is 250,000X lower, risks of whipping, perforation, burns, and guidewire / bur shattering are eliminated. Lacking a central stiff driveshaft, the more flexible magnetic thrombectomy device can be made smaller and navigated within tortuous neurovascular over standard guidewires without any heating.

[0311] In general, crossing the clot with a J-shaped microwire tip is considered less traumatic. However, this is not always possible and comes at the cost of potentially fragmenting or displacing the embolus into the distal vasculature.

[0312] Applying a small amount of a thrombolytic at the bur greatly improves the efficacy of the device. First, the thrombolytic rapidly destroys fibrin chains which would otherwise have the potential of wrapping around the bur. And second, the thrombolytic clears clot debris from the bur’s surface so that clot clearance does not stall. As a result, clot clearance is possible using a relatively smooth and atraumatic surface, instead of relying on traditional cutting edges that risk traumatizing the vessel.

[0313] The novel stall sensor is a simple circuit placed near the bur which inductively senses the bur magnet’s magnetic field, which is stronger than the applied external magnetic field. As a result, stalls are straightforward to detect.

[0314] And third, a magnetic guidewire whose tip can be deflected to better navigate tortuous vasculature using low (15-30mT) static magnetic fields. Obtaining distal clot access can be difficult due to internal guidewire tension as they are manipulated, leading to buckling, perforation, and breakage. Novel manufacturing methods were developed to achieve <01 mm magnets. Historically, NdBFe’s ceramic qualities result in small magnets often shattering or being thermally demagnetized. ~0O.2mm magnets have been made without magnetization loses. A unique shapable platinum cobalt (PtCo) permanent magnet alloy was also developed. Although magnetically weaker than NdBFe, PtCo retains greater magnetization for small (<01 mm) magnets. PtCo is well-suited for medical devices in that it is biocompatible, chemically resistant, and radiopaque. Because radiopaque gold caps used with NdBFe magnet are not required, guidewire tips can73105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center reflect more PtCo mass which increases the magnetic moment. In a rotating magnetic field, the guidewire’s tip is stable for frequencies >~100 RPM and generates negligible forces.

[0315] Magnetic thrombectomy procedures are compatible with standard thrombectomy workflows and can be used for primary and secondary distal occlusions. For procedures, the manual (or magnetic) guidewire is advanced across the occlusion (or stopped proximal to the clot if deemed safer). The magnetic thrombectomy device is then advanced to the clot over the guidewire. The catheter’s lumen can be used to administer contrast. The bur is then activated as a small thrombolytic dose is administered (~2mL tPA, ~1 mL TNK, >100X reduction vs. approved dose) to rapidly lyse the clot. Once blood flow is restored, the magnetic thrombectomy device can be used for other emboli without removal from the body.

[0316] Implant (e.g., pacemaker, stimulator) magnetic compatibility up to 3.0T (MRI) has been previously shown (~200X stronger than proposed). The proposed magnet’s EMF is 20X lower than the ~1 kHz nerve-stimulating threshold. For clinical use, standard MR mitigations will be followed (e.g., training and patient screening). Arterial injury is mitigated in that only <3g and <10mg are generated on the magnetic bur and guidewire, respectively (~15X and ~5000X smaller than endovascular device forces). Because the head is usually immobilized for thrombectomy, head motion is unable to affect device performance or safety. Because the magnetic fields are broad (~01 Ocm), this risk is relatively low regardless. X-ray magnetic compatibility was shown, where digital x-ray systems are immune if <20mT is generated on the x-ray anode and the imaging plate’s power supplies, which is the case for the prototype magnet (<5mT generated).

[0317] U.S. Patent No. 11 ,957,848 and U.S. Publication No. 2024 / 0207579 are incorporated herein by reference in their entirety.

[0318] To confirm the stagnant column formation, a distal M2 AIS phantom using CTA / MRA datasets was reproduced in glass at 1 :1 scale. Flow within phantoms reflected physiological rates for neurovascular arteries using a peristaltic pump. Water was loaded into the phantom, followed by Evans blue dye. Using a magnetic guidewire to place a microcatheter into the distal branch, studies were conducted using dye. It was observed74105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center that dye administered into the occluded branch was immediately diverted back into parent flow (FIG. 14). After 10 min, dye diffusion slowed to 0.12 mm / min.

[0319] For magnetic control, separate magnet systems were built to assess magnetic navigation (static fields) and thrombectomy (rotational fields). For magnetic navigation, a 14.7kg optimized ~50MGOe NdBFe (2.0kA-m2) magnet was manufactured. All magnet articulations occurred within a 020cm “pod”. The magnet was connected to a Universal Robots 6-axis TUV-certified robotic arm with integrated force and torque sensing (FIG. 8C). Testing confirmed UR16e magnetic compatibility. To model clinical use, a worst-case body profile phantom was used (95th percentile per anthropometry software). For magnet bur control, a transversely magnetized 15kg octagonal NdBFe ~50MGOe magnet assembly was made which confirmed ~2000 RPM rotational fields could be safely achieved. For both magnets, 15mT and 30mT magnetic fields (strong axis) were generated 19cm and 14cm from the cover’s front surface, respectively (FIG. 9). The 5G line’s maximum extent was 100cm, which is within hospital magnetic field guidelines.

[0320] Current static and rotational preliminary magnet systems need to be integrated. For this, stepper and speed-controlled motorized systems will be combined using the current 14.7kg magnet. Control components will be fitted within a safety shroud which will be attached to a multi-axis robotic arm. ~200RPM magnet rotation speeds will be assessed. Prior to conducting studies, mechanical and magnetic safety assessments will be made.

[0321] For the magnetic thrombectomy device, OTW ~03mm prolate spheroid and ~02mm cylindrical proof-of-concept devices were built using transverse-magnetized NdBFe ~50MGOe material with abrasive caps (FIGS. 7A-7B). FIG. 7A illustrates a 3 mm prolate burr. FIG. 7B illustrates a 3 mm cylindrical burr. ID for each was ~0O.5mm. Devices were mated with open-lumen catheters. Proof of concept ~01 mm non-OTW bur assemblies were prototyped (FIG. 15A). 00.014” guidewires successfully passed through the shaft and did not inhibit bur rotation. Without use of a guidewire, burs remained stable at ~200 RPM to within ~1 degree of deflection (FIG. 10B). Thus, OTW use during clot engagement is not required. The thrombectomy bur was able to easily withstand ~1 ,20075105119194.4PATENTAttorney Docket No. 104954-835903Via Patent CenterRPM speeds. Angling the plane of the rotating magnetic field resulted in up to 35 degrees of controlled deflection, enabling selective engagement of the occlusion (e.g., vessel curves and bifurcations) (FIG. 15B). In vitro assessments using calcified disk were made. Because calcium deposits represent the hardest occlusion component, burs were tested using standard calcified (Ultracal-30 powder) discs. Magnetic bur grinding forces measured -0.07N (1.5mm radius from center). Very small (<20pm) calcium debris resulted. Up to 1200 RPM was tested. No bur-induced heating occurred (<1 °C after ~1 hr of use).

[0322] Magnetic guidewire prototypes (0.014in) using 50MGOe NdBFe material were successfully built (FIG. 7C). FIG. 7C illustrates a 0.014 inch magnetic guidewire. Guidewire magnets (0.23mm diameter, 2mm length) replaced the platinum tips of commercial 0.014in guidewires with proper trackability, torqueability, flexibility, crossability, supportability, and coating. Radiodense gold hypotubes were affixed to the magnets, which were laser welded to guidewire support coils. Unique PtCo magnetic alloys were developed to improve performance. Studies confirmed magnetic guidewires were responsive to 15-30mT magnetic fields. Radiodensity testing confirmed similar opacity as a comparator Shinobi guidewire. For navigation studies, guidewires were responsive to ~30mT magnetic fields and achieved 42° deflections. Glass neurovascular phantoms were fabricated using neurovascular CTA / MRA datasets. Phantoms reflected a tortuous ICA loop out to MCA ~01 mm M3 segments. In contrast to manual guidewires, magnetic guidewires achieve access of all distal vessel segments using ~30mT (FIG. 15B).

[0323] It was found that a small amount of thrombolytic effectively cleared the clot debris from the abrasive surface of the magnetic bur. Diamond powder (Sigma Aldrich no. 483583) is an effective material for red blood cell rich clots.

[0324] Aspiration capability can be added to the magnetic bur catheter. The magnetic bur catheter can deliver contrast agents through a fluid delivery lumen. The bur catheter can include radiopaque materials. The external magnet can include multiple magnets or magnetic portions. Bur stall detection can be incorporated.Example 3:76105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0325] 3D localization and electroanatom ic mapping systems greatly reduced the need for x-ray imaging, thereby reducing patient and clinician exposure to ionizing radiation. The main 3D localization technologies for impedance-based and magnetic localization modalities (e.g., Ensite Precision by Abbott, Biosense CARTO by J&J, and AcQMap by Acutus, respectively). Further, the electronics associated with electroanatom ic sensing and 3D localization [J&J( Biosense), Abbott (EnSite), Acutus (AcQMap)] have been shown to be compatible with magnetic fields 6X stronger than those proposed. Of the two technologies, magnetic 3D localization is a better modality given that it is not affected by biological impendence or susceptibility. Further, magnetic localization, which uses AC fields, is unaffected by the magnetic fields generated by the magnet system. First, the system is highly accurate (<1mm accuracy). Second, the localization pad is radiotransparent and can be installed below the patient table (as with the Biosense system). Third, the localization field extends over the surrounding vessels. And fourth, the pad and localization coils are compatible with the magnet workstation and magnetic catheters.

[0326] Magnetic 3D localization was successfully integrated which updates the catheter’s location in real time to within <1 mm. Historically, the two main commercial 3D localization technologies use impedance-based and magnetic localization approaches (e.g., Ensite Precision by Abbott and Biosense CARTO by J&J, respectively), which are widely used given that precise catheter positional information can be captured without increasing ionizing radiation exposure. Of the two modalities, magnetic 3D localization is preferred given that its use of low DC magnetic fields is not affected by biological impendence or susceptibility. First, the system is highly accurate (<1mm). Second, the localization pad is radiotransparent and is installed below the patient table (as with Biosense’s system). Third, broader localization over the entire operating volume is provided. Fourth, the system is compatible with the magnet workstation and catheter magnets. And fifth, localization coils can be wound to as small as 00.3mm. An advantage of real-time 3D positional feedback is that integration is easier with existing robotic device controllers to support remote capabilities.Example 4:77105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0327] Acute ischemic stroke (AIS) is the result of a blood clot in a cerebral artery. Impacting more than 700,000 in the US each year, AIS is the leading US cause of longterm disability and the 5th leading cause of death. AIS events may be classified into three categories. First, -35% of AIS events result in mild baseline deficit (e.g., NIHSS < 5). Although “mild”, -60% experience poor outcomes and -35% are not functionally independent after 90 days. Mild stroke is often associated with primary distal occlusions. Second, -25% of AIS events are “wake-up” strokes, in which a stroke occurs during sleep, leaving 60% unable to independently ambulate after 90 days. And third, the remaining -40% of AIS events comprise the treatment-eligible population.

[0328] Early reperfusion is critical to improve neurological outcomes, for which intravenous (IV) thrombolysis and thrombectomy are the current standards. IV thrombolysis is approved within 4.5 hours of AIS onset. The only thrombolytic agent approved for AIS is Activase (alteplase, tPA, Genentech), which is associated with a -30% improvement in 90-day neurological outcomes, albeit with a -7X higher rate of symptomatic intracranial hemorrhage (sICH) (-7% vs. -1 %). Alteplase cleaves plasminogen to form the proteolytic enzyme plasmin which lyses clot fibrin and leads to clot dissolution. Although thrombolysis improves neurological outcomes for mild and wake-up strokes, it is not generally used in these populations due to thrombolysis’ elevated sICH rate. In contrast, thrombectomy of large vessel occlusion (LVO) is more effective than use of thrombolysis alone, where nearly 50% of AIS events are associated with thrombectomy-amenable LVOs. Altogether, thrombectomy is employed in -10% of all AIS events, which has steadily increased over the last decade. Thrombectomy achieves “good” outcomes (mRS 0-2) in -40% of cases when used within 6 hours of AIS onset (and 24hrs in some cases). However, performing thrombectomy for medium vessel occlusions (MeVOs) within distal vessels can pose risks despite primary MeVOs accounting for -40% of AIS events. Recent clinical trials demonstrated that current thrombectomy devices do not improve outcomes in AIS patients with medium and small vessel occlusions. Moreover, the risk of sICH was approximately 2.5X higher with these devices. In a trial, all-cause mortality was reported to be -5% higher compared to standard care. This is largely due to the large profile and stiffness of current78105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center thrombectomy devices, which are not reliably safe when navigating the tortuous anatomy of M2-M4 vessels. Further, several mechanical challenges limit the miniaturization of current stent retriever and aspiration devices. Stent retrievers require long, stiff shafts, and the deployed stents exert wall forces that may injure small vessels. Aspiration catheters require thick walls to prevent tip collapse, resulting in stiff devices with reduced navigability and limited aspiration performance.

[0329] Mechanical and aspiration thrombectomy also regularly generate thousands of clot fragments measuring from several hundred to several thousand microns in diameter, even with proximal flow control used as a mitigation. In -30% of cases, secondary occlusions are seen in one or more distal vessels. As a result, reperfusion of the brain is incomplete, and longer hospital stays, poorer outcomes, and a higher sICH incidences are possible. Taken together, most patients receiving thrombectomy are left moderately-to-severely disabled or die within 90 days, with only -11 % fully recovering (i.e. , mRS=0 at 90 days).

[0330] Although thrombectomy is much faster and more effective, intraarterial (IA) thrombolysis can more safely access MeVOs and more distal emboli and generates little embolic debris. A trial showed that 54% of prourokinase recipients achieved partial or complete reperfusion of primary M2 occlusions vs. 17% for those untreated, resulting in a 23% improvement in neurological outcomes (52% vs. 29%). Partial or complete recanalization using urokinase were reported for 76% and 33% of M2 and M3 vessel occlusions, respectively. More recent efforts using IA alteplase (tPA) and tenecteplase (TNK) for failed and rescue thrombectomy showed improved 90-day outcomes, although sICH risk was increased. Typically, 22 mg-tPA and 10 mg-TNK IA doses are administered at -1 mg / min.

[0331] Reasons why IV and IA thrombolysis fail include the following: First, all occlusions form proximal stagnant blood columns that prevent thrombolytics from reaching the clot’s face. Even when IA directed, most of the thrombolytic is washed back into blood flow. Second, thrombolytics slowly diffuse within the stagnant column at -2 mm / hour during which time the thrombolytic’s concentration and activity are substantially reduced due to Fick’s Law of Diffusion and short thrombolytic half-life (e.g., ~5min to79105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center~20min), respectively. And third, thrombolysis is slower and less effective against plateletrich ‘white’ clots (~14% of all clots) which have ~2X more platelets, ~60X more calcium and ~8X fewer red blood cells.

[0332] Taken together, current clinical consensus is that MeVOs (and more distal occlusions) represent a significant unmet need requiring safer and more effective treatment options.

[0333] The system described herein is a novel thrombectomy system that overcomes the limitations of current devices, offering safer and more effective treatment of MeVOs and smaller occlusions in small, tortuous cerebral vessels. A compact magnet console generating magnetic fields over 100X weaker than an MRI is used to spin a rotary magnetic tip with a specialized coating, which efficiently mixes thrombolytic at the clot while removing platelets and calcium.

[0334] The catheter 100 described herein is a novel over-the-wire (OTW) magnetic rotational thrombectomy device (FIG. 17) that uses very low magnetic fields (e.g., 15 - 30 mT) to rapidly lyse clots using low thrombolytic doses. The catheter 100 is compatible with approved neurovascular microwires and standard access tools, and integrates several novel innovations: First, in contrast to rotational and orbital atherectomy (RA / OA) systems from Boston Scientific and Cardiovascular Systems, 75-82 which rely on stiff driveshafts spinning at over 150,000 RPM to stabilize the tip and prevent whipping, the catheter 100 uses magnetic actuation to eliminate the need for a driveshaft. This allows for safer and more navigable devices as small as 1 mm. Because the catheter 100 operates at rotational speeds ~800X lower than RA / OA systems, it eliminates associated risks such as thermal injury, vessel perforation, guidewire fracture, and complications from sustained use. Because the catheter 100 lacks a driveshaft, it can deliver fluids at the tip, including thrombolytics and contrast media. Slightly larger catheter variants can accommodate bi-lumen catheters, enabling simultaneous aspiration. Interestingly, the catheter 100 remains remarkably stable during activation, even without use of a microwire. While anticipated clinical practice will be to advance a microwire across the clot before activating the catheter 100, it is possible to advance the catheter 100 ahead of the wire to clear an obstruction if resistance is encountered. Second, the catheter 10080105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center can include a specialized tip featuring a shape and coating designed to rapidly lyse clots and clear platelet and calcium deposits. By administering thrombolytic directly at the tip, the catheter 100 uses low rotational speeds (e.g., <200 RPM) to rapidly lyse clot. Active mixing at the clot enables the use of significantly lower thrombolytic doses. Studies demonstrate that lysis can be achieved in under 5 minutes using a thrombolytic dose ~10,000X lower than standard IA thrombolysis. Importantly, more complete reperfusion is likely achieved through improved thrombolytic distribution within the clot, allowing downstream fragments to continue lysing after recanalization. Although all thrombectomy devices carry a risk of endothelial injury, the catheter 100 minimizes this risk by using a fine biocompatible powder coating on its tip to selectively clear calcium and platelet deposits. Third, the catheter 100 is the first thrombectomy device to integrate 3D localization, which provides precise real-time catheter positional information without increasing ionizing radiation exposure. When used with the Angio suite compatible 3D localization system, the catheter 100 can be easily registered to the C-arm isocenter without requiring integration with the imaging manufacturer’s software. To aid in identifying the clot surface and recanalization, the catheter 100 also incorporates stall and blood flow sensors. And fourth, the catheter 100 is the first thrombectomy device small and maneuverable enough to safely support a trans radial approach.

[0335] An external magnet system 700 was developed to control the catheter 100 and magnetic microwires and catheters (FIG. 22). By solving the magnetic dipole equation, the magnet’s placement can be reverse calculated to generate a magnetic rotational plane whose axis aligns with the central axis of the magnetic tip 104 of the catheter 100. The same magnetic rotational plane applied to the magnetic tip 104 is preserved regardless of how the magnet subassembly “pod” is positioned within the predefined plane. Because the catheter tip rotation is the same for multiple C-arm placements, preferred C-arm angulation is preserved. The external magnet system 700 reflects unique features. First, the applied magnetic field inherently limits the applied torque and force to safe thresholds. Unlike RA / OA devices, which can generate excessive torque capable of perforating vessels or entrapping devices, the magnetic field functions as a natural clutch, safely capping the applied torque. If needed, the magnetic torque can81105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center be increased by simply moving the magnet closer. Second, by tilting the rotating magnet, guidewire bias can be overcome, allowing selective engagement of clots and angulation away from vessel walls. Third, the magnetic plane can be adjusted to induce an orbital tip motion, enabling larger clot volume engagement. And fourth, low static magnetic fields (15 - 30 mT) can be used to navigate magnetically enabled devices within the vasculature. The same (static) magnetic field direction can be maintained regardless of how the pod is manually positioned. Magnetic strength is then increased by simply moving the magnet towards the patient. Importantly, precise pod placement is not required due to the magnetic field being relatively uniform over a ~01 Ocm sphere.

[0336] To position the pod, a robotic arm is used, which possesses integrated force and torque sensing in all joints. The robotic arm is rated for use in sanitary environments, supports hand-guided positioning, can carry a 20 kg payload, and uses a portable counterweighted base to mitigate tipping risks. The robotic arm’s 175 cm extension allows the magnet pod to be fully removed from Angio suite workflows without repositioning the base, which was confirmed in bench testing using a worst-case body profile phantom (95th percentile per anthropometry software). Testing also confirmed that robotic arm is compatible with the magnet subsystem. An LCD screen attached to the pod assists clinicians in manually positioning the magnet; however, the robotic arm could also be used to constrain pod movement within the preferred plane. Manual positioning eliminates the collision risks associated with autonomous robotic arm motions.

[0337] Physicians consider the current magnet console already well suited for an early human feasibility study based on the following: (1 ) single C-arm setups are already widely used in thrombectomy procedures; (2) biplane imaging increases exposure to ionizing radiation and contrast; (3) the catheter 100 provides its own 3D localization, reducing the need for bi-plane imaging; and (4) the current magnet console is compatible with biplane imaging procedures, provided one C-arm is temporarily repositioned during therapy.

[0338] Historically, small magnet manufacturing has difficulty achieving <1 mm magnet diameters and thin walled structures. Because permanent magnets possess ceramic qualities, small feature manufacturing often fails due to shattering and thermal82105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center demagnetization. To overcome this, low-chatter, thermally controlled methods were developed to achieve NdBFe magnet features as small as 0.3 mm (diameter) without magnetization loses. A novel platinum cobalt (PtCo) permanent magnet alloy was developed. PtCo was first developed in the 1930’s; however, its use as a permanent magnet was discontinued in the 1950’s once magnetically-stronger sintered magnets were manufactured (e.g., SmCo and NdBFe). In contrast to NdFeB, PtCo is well suited for medical devices due to its biocompatibility, chemical resistance, and increased radiopacity. Though magnetically weaker than NdFeB, PtCo’s ductility allows smaller, more complex geometries. Unlike sintered magnets, PtCo retains magnetization below 00.3 mm once heat-treated, enabling stronger magnets for small devices controllable using low (<30 mT) magnetic fields.

[0339] An OEM localization pad covers heart and head volumes, is radiotransparent, and is compatible with the C-arm and patient table. Six-degree-of- freedom coils were integrated and shown to be compatible with the magnet console. Localization accuracy was verified to be <1 mm. 3D localization sensors as small as ~0.3 mm were successfully fabricated. The magnet console can be registered to the C- arm isocenter either by using precisely positioned floor locks or by integrating a 3D position sensor with the pod.

[0340] In short, the catheter 100 integrates into standard thrombectomy workflows for AIS patients. After accessing the cervical ICA, an approved microwire and microcatheter are used to cross the clot. The catheter 100 is advanced over the microwire, guided by 3D positioning information and visual LCD indicators on the magnet pod. The catheter 100 is activated while an FDA approved thrombolytic is infused over ~5 minutes. Sensors detect clot contact and monitor for flow restoration, with final reperfusion assessed via a local contrast injection near the tip. The catheter 100 can treat multiple MeVOs without device removal. Upon completion, interventional tools are withdrawn per standard workflow, and the magnet and 3D localization systems are cleaned and stowed.

[0341] To extend the catheter 100 to treat MeVOs in distal vessels, a 00.014 in magnetic microwire was developed that is compatible with standard over-the-wire tools and operated via a manual manipulator. Machining methods enabled fabrication of83105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center-0250 m NdFeB magnets, sealed within laser-welded gold (radiopaque) hypotubes and mounted on commercial guidewire cores. PtCo coils replaced conventional platinum support coils to enhance magnetic responsiveness, allowing reliable control with <30 mT fields. For localization, 00.3 mm coils were developed, marking the first instance of 3D- localized guidewires.

[0342] A novel linkage-based catheter was developed to overcome the fixed shapes and internal tension of manual catheters, assisting aortic navigation from femoral and radial access. The system combines a NdFeB collar with a linkage catheter that eliminates the restoring forces typical of manual catheters, allowing unlocked deflection using low magnetic fields (15-30 mT). A manual slider locks the magnetically-selected shape using internal locking line, which sets a fixed shape so that the catheter 100, microcatheters, guidewires, and microwires can be passed. The design supports fluid delivery and aspiration without affecting catheter stability. Several safety features are built in. A flexible biocompatible silicone membrane isolates the linkage from blood. If a link fails, tension lines act as retrieval tethers. And, when the lines break, the catheter reverts to a relaxed state for easy removal. Lastly, 3D localization was successfully integrated and demonstrated in a large animal model.

[0343] Most implants (e.g., pacemakers, stimulators, etc.) are magnetically compatibility up to 3.0T (which are -100X stronger than employed). The described magnet’s EMF is -300X lower than the ~1 kHz nerve-stimulating threshold. For clinical use, standard MR mitigations will be followed (e.g., training and patient screening). Magnetic forces on the catheter 100 and magnetic catheters are -8X lower compared to approved catheters (~350mg vs. ~2500mg), and magnetic microwire forces are -4X lower than approved microwires (~100mg vs. ~700mg). Head motion will not affect the catheter 100 performance or safety given that the applied magnetic field is relatively uniform over -010cm. Further, head motion can be safely constrained using standard methods. X-ray magnetic compatibility was previously shown, where digital c-arms are immune if <20mT is generated on the x-ray anode and the imaging plate’s power supplies, which is the case for catheter’s magnet console (<5mT generated).Illustrative Aspects84105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0344] Illustrative aspects of the present disclosure include:

[0345] Aspect 1 . A system for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the system comprising: a catheter comprising: a catheter body including at least one lumen defining an axis; a spindle attached to the catheter body; and a magnetic tip rotatably mounted to the spindle; and an external magnet operable to generate a magnetic field.

[0346] Aspect 2. The system of Aspect 1 , wherein at least a portion of the magnetic tip has an abrasive surface.

[0347] Aspect 3. The system of Aspect 2, wherein the abrasive surface includes an abrasive coating.

[0348] Aspect 4. The system of Aspect 3, wherein the abrasive coating comprises a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating.

[0349] Aspect 5. The system of Aspect 4, wherein the bonded powdered coating includes platinum, gold, silica, or other metals.

[0350] Aspect 6. The system of any one of Aspects 2-5, wherein the abrasive surface includes an etched, knurled, and / or stippled surface.

[0351] Aspect 7. The system of any one of Aspects 2-6, wherein the abrasive surface is a micropatterned surface operable to improve emboli dissolution.

[0352] Aspect 8. The system of any one of Aspects 1-7, the system further comprising a guidewire operable to guide the catheter, the guidewire contained within the at least one lumen.

[0353] Aspect 9. The system of Aspect 8, wherein the magnetic field is operable to control a movement of the guidewire.

[0354] Aspect 10. The system of Aspect 8 or 9, wherein the guidewire comprises a magnetic material.

[0355] Aspect 11. The system of Aspect 10, wherein the magnetic material includes PtCo and / or NdBFe.

[0356] Aspect 12. The system of Aspect 10 or 11 , wherein the magnetic material increases a total magnetic mass of the catheter, thereby improving a maximum degree85105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center of deflection of the catheter and / or decreasing a strength of the magnetic field necessary to deflect the catheter.

[0357] Aspect 13. The system of any one of Aspects 1-12, wherein the magnetic field is operable to selectively rotate the magnetic tip and / or selectively control a movement of the catheter.

[0358] Aspect 14. The system of any one of Aspects 1-13, wherein the magnetic field is operable to cause the magnetic tip to rotate about the axis at a rotation rate of about 60 rpm to about 2,000 rpm.

[0359] Aspect 15. The system of Aspect 1 , wherein the rotation rate is about 200 rpm to about 2,000 rpm.

[0360] Aspect 16. The system of Aspect 14 or 15, wherein the rotation rate is about 1 ,000 rpm to about 2,000 rpm.

[0361] Aspect 17. The system of Aspect 14 or 15, wherein the rotation rate is about 200 rpm to about 500 rpm.

[0362] Aspect 18. The system of any one of Aspects 14-16, wherein the rotation rate is about 1 ,200 rpm.

[0363] Aspect 19. The system of any one of Aspects 14-18, wherein rotation of the magnetic tip stabilizes at the rotation rate.

[0364] Aspect 20. The system of any one of Aspects 1-19, wherein the magnetic field is operable to steer the magnetic tip within the artery, cavity, vein, or blood vessel, thereby steering the catheter.

[0365] Aspect 21. The system of any one of Aspects 1 -20, the system further comprising a fluid source operable to provide a fluid to the at least one lumen.

[0366] Aspect 22. The system of Aspect 21 , wherein the fluid includes one or more drugs, x-ray contrast agents, Von Willebrand factor, acids, neuroprotectants, DNAse, other therapeutic agents, and other diagnostic agents.

[0367] Aspect 23. The system of Aspect 22, wherein the one or more drugs includes a thrombolytic.

[0368] Aspect 24. The system of Aspect 23, wherein the thrombolytic includes alteplase, Tenecteplase, urokinase, desmoteplase, reteplase, and / or streptokinase.86105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0369] Aspect 25. The system of any one of Aspects 21 -14, wherein the fluid source provides a pressurized fluid through the at least one lumen, wherein the pressurized fluid rotates the magnetic tip.

[0370] Aspect 26. The system of any one of Aspects 1 -25, wherein the at least one lumen includes a guidewire lumen, an aspiration lumen, and a fluid delivery lumen.

[0371] Aspect 27. The system of Aspect 26, wherein the guidewire lumen, the aspiration lumen, and the fluid delivery lumen are concentric lumens.

[0372] Aspect 28. The system of Aspect 26, wherein the guidewire lumen, the aspiration lumen, and the fluid delivery lumen are side-by-side lumens.

[0373] Aspect 29. The system of any one of Aspects 26-28, wherein the aspiration lumen is operable to provide a vacuum force.

[0374] Aspect 30. The system of Aspect 29, wherein the vacuum force causes the magnetic tip to rotate.

[0375] Aspect 31. The system of any one of Aspects 1-30, wherein the magnetic tip is a distal magnetic bur.

[0376] Aspect 32. The system of any one of Aspects 1-31 , wherein the magnetic tip includes one or more fluid delivery ports.

[0377] Aspect 33. The system of Aspect 32, wherein the one or more fluid delivery ports includes a distal fluid delivery port at a tip of the rotary magnetic tip.

[0378] Aspect 34. The system of Aspect 32, wherein the one or more fluid delivery ports includes one or more side delivery ports disposed on a circumferential surface of the magnetic tip.

[0379] Aspect 35. The system of any one of Aspects 1-34, wherein the magnetic tip includes one or more aspiration ports.

[0380] Aspect 36. The system of Aspect 35, wherein the one or more aspiration ports include a distal aspiration port at a tip of the magnetic tip and / or one or more side aspiration ports disposed on a circumferential surface of the magnetic tip.

[0381] Aspect 37. The system of any one of Aspects 1 -36, wherein a rotation of the magnetic tip is operable to provide a vacuum pressure, thereby causing fluids to be vacuumed into the at least one lumen.87105119194.4PATENTAttorney Docket No. 104954-835903 Via Patent Center

[0382] Aspect 38. The system of any one of Aspects 1 -37, the system further comprising a 3D localization subsystem.

[0383] Aspect 39. The system of any one of Aspect 38, wherein the 3D localization subsystem comprises a robotic arm.

[0384] Aspect 40. The system of Aspect 38 or 39, wherein the 3D localization subsystem is a magnetic 3D localization subsystem.

[0385] Aspect 41 . The system of Aspect 40, wherein the magnetic 3D localization subsystem uses AC and / or DC fields.

[0386] Aspect 42. The system of Aspect 41 , wherein the magnetic 3D localization subsystem is operable to locate the magnetic tip within 1 mm.

[0387] Aspect 43. The system of Aspect 42, wherein the magnetic 3D localization subsystem includes a localization pad.

[0388] Aspect 44. The system of Aspect 43, wherein the localization pad is radiotranslucent.

[0389] Aspect 45. The system of Aspect 43, wherein the localization pad is operable to be installed under a patient table.

[0390] Aspect 46. The system of Aspect 43, wherein the magnetic 3D localization subsystem generates a localization field over an occlusion site and surrounding blood vessels, cavities, arteries, and veins of a patient.

[0391] Aspect 47. The system of Aspect 43, wherein the magnetic 3D localization subsystem further includes one or more localization coils.

[0392] Aspect 48. The system of Aspect 47, wherein the localization pad and the one or more localization coils are compatible with the magnetic tip and the external magnet.

[0393] Aspect 49. The system of Aspect 47, wherein the one or more localization coils have a diameter of less than about 0.3 mm.

[0394] Aspect 50. The system of any one of Aspects 40-49, wherein the magnetic 3D localization subsystem is operable to update a position of the magnetic tip in real-time within an accuracy threshold of about 1 mm.88105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0395] Aspect 51. The system of any one of Aspects 40-50, wherein the magnetic 3D localization subsystem is not affected by biological impendence or susceptibility.

[0396] Aspect 52. The system of any one of Aspects 1 -51 , wherein the catheter further comprises one or more 3D localization sensors.

[0397] Aspect 53. The system of Aspect 52, wherein the one or more 3D localization sensors have at least five degrees of freedom.

[0398] Aspect 54. The system of Aspect 52 or 53, wherein the one or more 3D localization sensors are operable to provide a real-time angulation and / or a real-time position of the magnetic tip.

[0399] Aspect 55. The system of any one of Aspects 1-54, wherein the magnetic tip has a shape operable to break down a clot.

[0400] Aspect 56. The system of any one of Aspects 1-55, wherein the magnetic tip includes helical grooves.

[0401] Aspect 57. The system of any one of Aspects 1-56, wherein the magnetic tip includes one or more wings.

[0402] Aspect 58. The system of Aspect 57, wherein the one or more wings are evenly spaced.

[0403] Aspect 59. The system of any one of Aspects 1-58, wherein the magnetic tip comprises a dome shape, a prolate shape, a cylindrical shape, a spherical shape, a cube shape, a cuboid shape, or a triangular prism shape.

[0404] Aspect 60. The system of Aspect 59, wherein the dome shape increases in diameter from a distal end furthest from the catheter body to a proximal end, or wherein the dome shape increases in diameter from the proximal end to the distal end.

[0405] Aspect 61. The system of any one of Aspects 1-60, wherein the magnetic tip includes one or more cutting edges.

[0406] Aspect 62. The system of Aspect 61 , wherein the one or more cutting edges are disposed on a distal tip of the magnetic tip and / or a circumferential surface of the magnetic tip.

[0407] Aspect 63. The system of any one of Aspects 1-62, wherein the magnetic tip has one or more teeth on a distal end furthest from the catheter body.89105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0408] Aspect 64. The system of any one of Aspects 1-63, wherein the magnetic tip has one or more teeth on a circumferential surface of the magnetic tip.

[0409] Aspect 65. The system of any one of Aspects 1-64, wherein the magnetic tip is operable to mix a fluid as the magnetic tip rotates.

[0410] Aspect 66. The system of Aspect 65, wherein the magnetic tip mixes the fluid outside of the magnetic tip and / or the fluid contained within the magnetic tip.

[0411] Aspect 67. The system of any one of Aspects 1-66, wherein an applied torque on the magnetic tip corresponds to a distance between the magnetic tip and the external magnet.

[0412] Aspect 68. The system of Aspect 67, wherein a rotation speed of the magnetic tip corresponds to a rotation speed of the external magnet.

[0413] Aspect 69. The system of any one of Aspects 1-68, wherein the magnetic tip has a diameter of about 1 mm to about 5 mm or about 2 mm to about 3 mm.

[0414] Aspect 70. The system of any one of Aspects 1-69, wherein the magnetic tip comprises PtCo, SmCo, NdBFe, and / or bonded magnets.

[0415] Aspect 71 . The system of any one of Aspects 1-70, wherein the artery, vein, cavity, or blood vessel is located in an arm, leg, brain, heart, neck, torso, or any body part of a patient.

[0416] Aspect 72. The system of any one of Aspects 1-71 , wherein the system is used for atherectomies and / or thrombectomies.

[0417] Aspect 73. The system of any one of Aspects 1-72, wherein the magnetic field is 50 mT or less.

[0418] Aspect 74. The system of any one of Aspects 1-73, wherein the magnetic field is 30 mT or less.

[0419] Aspect 75. The system of any one of Aspects 1-74, wherein a tip of the magnetic tip includes a radiopaque material and a body of the magnetic tip includes a radiotranslucent material.

[0420] Aspect 76. The system of Aspect 75, wherein one or more proximal connectors include the radiopaque material.90105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0421] Aspect 77. The system of Aspect 76, wherein a fixed distance is maintained between the tip and the one or more proximal connectors.

[0422] Aspect 78. The system of Aspect 77, the system further comprising an X- ray machine operable to locate the radiopaque material when the catheter is in use.

[0423] Aspect 79. The system of any one of Aspects 1-78, wherein a circumferential surface of the magnetic tip includes an angled ribbon of radiopaque material.

[0424] Aspect 80. The system of any one of Aspects 1-79, wherein at least a portion of the magnetic tip includes a radiopaque material.

[0425] Aspect 81 . The system of Aspect 80, wherein the radiopaque material allows visualization of a rotation of the magnetic tip under a fluoroscope and / or another imaging system.

[0426] Aspect 82. The system of any one of Aspects 1-81 , wherein the magnetic field provides an off-axis magnetic force to the magnetic tip, thereby causing an orbital motion and / or an erratic motion, wherein the orbital motion and / or erratic motion is operable to breakdown or debulk a larger volume of the occlusion as compared to a nonorbital device.

[0427] Aspect 83. The system of Aspect 82, wherein the orbital motion and / or the erratic motion promote stirring of a fluid within the catheter or outside of the catheter.

[0428] Aspect 84. The system of any one of Aspects 1-83, wherein the magnetic tip has a tip comprising a rough surface.

[0429] Aspect 85. The system of any one of Aspects 1 -84, wherein the external magnet is cylindrical, octagonal, or another shape.

[0430] Aspect 86. The system of any one of Aspects 1 -85, wherein the external magnet comprises a high energy material.

[0431] Aspect 87. The system of Aspect 86, wherein the high energy material is NdBFe.

[0432] Aspect 88. The system of any one of Aspects 1 -87, wherein the external magnet has a mass of about 10 kg to about 30 kg.91105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0433] Aspect 89. The system of any one of Aspects 1 -88, wherein the external magnet is operable to be positioned in three dimensions around a patient.

[0434] Aspect 90. The system of any one of Aspects 1 -89, the system further comprising an external magnet assembly, the external magnet assembly comprising a robotic arm coupled to the external magnet, the robotic arm configured to position the external magnet with respect to the catheter.

[0435] Aspect 91. The system of any one of Aspects 1 -90, wherein the external magnet comprises an electromagnet operable to generate temporal magnetic fields.

[0436] Aspect 92. The system of any one of Aspects 1-91 , wherein the magnetic tip has a selective surface.

[0437] Aspect 93. The system of Aspect 92, wherein the selective surface is configured to convey fluids and / or shear the occlusion.

[0438] Aspect 94. The system of any one of Aspects 1 -93, the catheter further comprising a speed sensor disposed on or near the spindle and / or magnetic tip, the speed sensor configured to measure a rotation speed of the magnetic tip.

[0439] Aspect 95. A method for breaking down or clearing an occlusion in an artery, blood vessel, vein, or cavity, the method comprising: navigating a catheter comprising a rotatable magnetic tip to the occlusion; providing, via an external magnet, a magnetic field operable to rotate the rotatable magnetic tip; and breaking down and / or clearing the occlusion by grinding the occlusion with the rotatable magnetic tip.

[0440] Aspect 96. The method of Aspect 95, wherein navigating the catheter comprises receiving a guidewire through at least one lumen of the catheter and steering the catheter along the guidewire.

[0441] Aspect 97. The method of Aspect 95 or 96, the method further comprising providing one or more diagnostic and / or therapeutic agents to the occlusion via a fluid delivery lumen of the catheter.

[0442] Aspect 98. The method of any one of Aspects 95-97, the method further comprising providing aspiration to an occlusion site of the occlusion by providing a vacuum pressure through an aspiration lumen of the catheter.92105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0443] Aspect 99. The method of any one of Aspects 95-99, the method further comprising locating a position and / or angulation of the catheter in real-time.

[0444] Aspect 100. A system for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the system comprising: a catheter comprising: a catheter body including at least one lumen defining an axis; a spindle attached to the catheter body; and a magnetic rotor rotatably mounted to the spindle; and an external magnet operable to generate a magnetic field.

[0445] Aspect 101. The system of Aspect 100, wherein the magnetic rotor is a magnetic tip.

[0446] Aspect 102. The system of Aspect 100 or 101 , wherein the magnetic rotor includes a distal tip.

[0447] Aspect 103. The system of Aspect 102, wherein the distal tip includes a cap configured to breakdown and / or debulk the occlusion.

[0448] Aspect 104. The system of any one of Aspects 100-103, wherein the magnetic rotor includes a bit to breakdown and / or debulk the occlusion.

[0449] Aspect 105. A catheter for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity, the catheter comprising: a catheter body defining a longitudinal axis; at least one lumen contained within the catheter body; a mounting mechanism attached to the catheter body; and a magnetic tip rotatably coupled to the mounting mechanism, wherein the magnetic tip is operable to rotate about the longitudinal axis in response to a magnetic field being applied to the magnetic tip.

[0450] Aspect 106. The catheter of Aspect 105, wherein the magnetic tip comprises an abrasive surface operable to grind the occlusion.

[0451] Aspect 107. The catheter of Aspect 106, wherein the abrasive coating comprises a diamond powder coating, a rubber coating, a polymeric coating, a glassbased powder coating, and / or a bonded powdered coating.

[0452] Aspect 108. The catheter of any one of Aspects 105-107, wherein the at least one lumen comprises a guidewire lumen operable to receive a guidewire, an aspiration lumen operable to receive fluid proximal to the occlusion, and a fluid delivery lumen operable to deliver fluid to the occlusion.93105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0453] Aspect 109. The catheter of Aspect 108, wherein rotation of the magnetic tip is operable to generate a vacuum force operable to cause fluid to be drawn into the aspiration lumen.

[0454] Aspect 110. The catheter of Aspect 108 or 109, wherein rotation of the magnetic tip is operable to mix fluid delivered to the occlusion via the fluid delivery lumen.

[0455] Aspect 111. The catheter of any one of Aspects 105-110, wherein the mounting mechanism comprises a spindle, a slip joint, or a ball joint.

[0456] Aspect 112. A system for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity, the system comprising: a catheter comprising: a catheter body defining a longitudinal axis; at least one lumen contained within the catheter body; a mounting mechanism attached to the catheter body; and a magnetic tip rotatably coupled to the mounting mechanism; and an external magnetic operable to generate a magnetic field, wherein the magnetic field is operable to cause the magnetic tip to rotate about the longitudinal axis.

[0457] Aspect 113. The system of Aspect 112, wherein the magnetic tip comprises an abrasive surface operable to grind the occlusion.

[0458] Aspect 114. The system of Aspect 113, wherein the abrasive coating comprises a diamond powder coating, a rubber coating, a polymeric coating, a glassbased powder coating, and / or a bonded powdered coating.

[0459] Aspect 115. The system of any one of Aspects 112-11 , wherein the at least one lumen comprises a guidewire lumen operable to receive a guidewire, an aspiration lumen operable to receive fluid proximal to the occlusion, and a fluid delivery lumen operable to deliver fluid to the occlusion.

[0460] Aspect 116. The system of Aspect 115, wherein rotation of the magnetic tip is operable to generate a vacuum force operable to cause fluid to be drawn into the aspiration lumen.

[0461] Aspect 117. The system of Aspect 115 or 116, wherein rotation of the magnetic tip is operable to mix fluid delivered to the occlusion via the fluid delivery lumen.

[0462] Aspect 118. The system of any one of Aspects 112-117, wherein the mounting mechanism comprises a spindle, a slip joint, or a ball joint.94105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0463] Aspect 119. A method for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity, the method comprising: navigating a catheter comprising a rotatable magnetic tip to the occlusion; providing, via an external magnet, a magnetic field operable to rotate the rotatable magnetic tip; and breaking down and / or clearing the occlusion by grinding the occlusion with the rotatable magnetic tip.

[0464] Aspect 120. The method of Aspect 119, wherein navigating the catheter comprises receiving a guidewire through at least one lumen of the catheter and steering the catheter along the guidewire to the occlusion.

[0465] Aspect 121. The method of Aspect 119 or 120, further comprising providing, via a fluid delivery lumen of the catheter, a fluid to the occlusion.

[0466] Aspect 122. The method of any one of Aspects 119-121 , further comprising aspirating an occlusion site by rotating the magnetic tip, thereby providing a vacuum force to the occlusion site.

[0467] Aspect 123. The method of any one of Aspects 119-122, wherein the rotatable magnetic tip comprises an abrasive surface, and wherein the abrasive surface comprises a diamond powder coating, a rubber coating, a polymeric coating, a glassbased powder coating, and / or a bonded powdered coating.

[0468] Aspect 124. The method of any one of Aspects 119-123, wherein rotation of the rotatable magnetic tip stirs the fluid.

[0469] Aspect 125. A catheter for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the catheter comprising: a catheter body comprising: at least one lumen defining an axis; and a ball joint connector; and a magnetic tip assembly comprising: a magnetic tip holder comprising a ball operable to be received within the ball joint connector; and a magnetic tip coupled to the magnetic tip holder, wherein movement of the magnetic tip is operable to be controlled by an external magnetic field.

[0470] Aspect 126. The catheter of Aspect 125, wherein the at least one lumen includes an inner lumen that extends through the magnetic tip assembly to a distal end of the magnetic tip.95105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center

[0471] Aspect 127: The catheter of Aspect 125 or 126, wherein the at least one lumen further includes a localization sensor lumen.

[0472] Aspect 128. The catheter of Aspect 127, further comprising a localization sensor contained within the localization sensor lumen.

[0473] Aspect 129. A catheter for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the catheter comprising: a catheter body having a longitudinal axis; and a magnetic tip rotatably coupled to the catheter body, the magnetic tip operable to rotate about the longitudinal axis.

[0474] Aspect 130. The catheter of Aspect 129, wherein the magnetic tip rotates about the longitudinal axis when supplied an external magnetic field.

[0475] Aspect 131. The catheter of Aspect 129 or 130, wherein the magnetic tip includes a shape and / or surface configured to grind the occlusion.

[0476] Aspect 132. The catheter of Aspect 131 , wherein the surface includes an abrasive surface.

[0477] Aspect 133. The catheter of Aspect 131 or 132, wherein the shape and / or the surface is configured to break down the occlusion without the use of a thrombolytic and / or other therapeutic agent.

[0478] Aspect 134. The catheter of any one of Aspects 129-133, wherein the magnetic tip is configured to capture the occlusion.

[0479] Aspect 135. The catheter of Aspect 134, wherein the magnetic tip is operable to rotate the captured occlusion.

[0480] Aspect 136. The catheter of Aspect 135, further comprising a fluid delivery lumen operable to deliver a thrombolytic and / or other therapeutic agent.

[0481] Aspect 137. The catheter of Aspect 136, wherein the thrombolytic and / or other therapeutic agent breaks down the occlusion as the occlusion is rotated by the magnetic tip.

[0482] Aspect 138. The catheter of any one of Aspects 129-137, wherein the magnetic tip includes a net.

[0483] Aspect 139. The catheter of any one of Aspects 129-137, further comprising at least one lumen.96105119194.4PATENT Attorney Docket No. 104954-835903 Via Patent Center

[0484] Aspect 140. The catheter of Aspect 139, wherein the at least one lumen is operable to receive a guidewire, deliver a fluid to the occlusion, and / or aspirate an occlusion site including the occlusion and / or a surrounding area.

[0485] Aspect 141. The catheter of Aspect 139 or 140, wherein the at least one lumen includes a single lumen operable to receive a guidewire, deliver a fluid to the occlusion, and / or aspirate an occlusion site including the occlusion and / or a surrounding area.

[0486] Aspect 142. The catheter of Aspect 139 or 140, wherein the at least one lumen includes a fluid delivery lumen, an aspiration lumen, and a guidewire lumen.

[0487] The disclosures shown and described above are only examples. Even though numerous characteristics and advantages of the present technology have been set forth in the foregoing description, together with details of the structure and function of the present disclosure, the disclosure is illustrative only, and changes may be made in the detail, especially in matters of shape, size and arrangement of the parts within the principles of the present disclosure to the full extent indicated by the broad general meaning of the terms used in the attached claims. It will therefore be appreciated that the examples described above may be modified within the scope of the appended claims.97105119194.4

Claims

PATENTAttorney Docket No. 104954-835903Via Patent CenterClaimsWhat is claimed is:1 . A catheter for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity, the catheter comprising: a catheter body defining a longitudinal axis; at least one lumen contained within the catheter body; a mounting mechanism attached to the catheter body; and a magnetic tip rotatably coupled to the mounting mechanism, wherein the magnetic tip is operable to rotate about the longitudinal axis in response to a magnetic field being applied to the magnetic tip.

2. The catheter of claim 1 , wherein the magnetic tip comprises an abrasive surface operable to grind the occlusion.

3. The catheter of claim 2, wherein the abrasive surface comprises a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating.

4. The catheter of claim 1 , wherein the at least one lumen comprises a guidewire lumen operable to receive a guidewire, an aspiration lumen operable to receive fluid proximal to the occlusion, and / or a fluid delivery lumen operable to deliver fluid to the occlusion.

5. The catheter of claim 4, wherein rotation of the magnetic tip is operable to generate a vacuum force operable to cause fluid to be drawn into the aspiration lumen.

6. The catheter of claim 4, wherein rotation of the magnetic tip is operable to mix fluid delivered to the occlusion via the fluid delivery lumen.

7. The catheter of claim 1 , wherein the mounting mechanism comprises a spindle, a slip joint, or a ball joint.98105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center8. A system for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity, the system comprising: a catheter comprising: a catheter body defining a longitudinal axis; at least one lumen contained within the catheter body; a mounting mechanism attached to the catheter body; and a magnetic tip rotatably coupled to the mounting mechanism; and an external magnet operable to generate a magnetic field, wherein the magnetic field is operable to cause the magnetic tip to rotate about the longitudinal axis.

9. The system of claim 8, wherein the magnetic tip comprises an abrasive surface operable to grind the occlusion.

10. The system of claim 9, wherein the abrasive surface comprises a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating.

11. The system of claim 8, wherein the at least one lumen comprises a guidewire lumen operable to receive a guidewire, an aspiration lumen operable to receive fluid proximal to the occlusion, and a fluid delivery lumen operable to deliver fluid to the occlusion.

12. The system of claim 11 , wherein rotation of the magnetic tip is operable to generate a vacuum force operable to cause fluid to be drawn into the aspiration lumen.

13. The system of claim 11 , wherein rotation of the magnetic tip is operable to mix fluid delivered to the occlusion via the fluid delivery lumen.

14. The system of claim 11 , wherein the mounting mechanism comprises a spindle, a slip joint, or a ball joint.99105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center15. A method for breaking down and / or clearing an occlusion in an artery, vein, blood vessel, and / or cavity, the method comprising: navigating a catheter comprising a rotatable magnetic tip to the occlusion; providing, via an external magnet, a magnetic field operable to rotate the rotatable magnetic tip; and breaking down and / or clearing the occlusion by grinding the occlusion with the rotatable magnetic tip.

16. The method of claim 15, wherein navigating the catheter comprises receiving a guidewire through at least one lumen of the catheter and steering the catheter along the guidewire to the occlusion.

17. The method of claim 15, further comprising providing, via a fluid delivery lumen of the catheter, a fluid to the occlusion.

18. The method of claim 15, further comprising aspirating an occlusion site by rotating the rotatable magnetic tip, thereby providing a vacuum force to the occlusion site.

19. The method of claim 15, wherein the rotatable magnetic tip comprises an abrasive surface, and wherein the abrasive surface comprises a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating.

20. The method of claim 17, wherein rotation of the rotatable magnetic tip stirs the fluid.21 . A system for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the system comprising: a catheter comprising: a catheter body including at least one lumen defining an axis; a spindle attached to the catheter body; and a magnetic tip rotatably mounted to the spindle; and an external magnet operable to generate a magnetic field.100105119194.4PATENT Attorney Docket No. 104954-835903Via Patent Center22. The system of claim 21 , wherein at least a portion of the magnetic tip has an abrasive surface.

23. The system of claim 22, wherein the abrasive surface includes an abrasive coating.

24. The system of claim 23, wherein the abrasive coating comprises a diamond powder coating, a rubber coating, a polymeric coating, a glass-based powder coating, and / or a bonded powdered coating.

25. The system of claim 24, wherein the bonded powdered coating includes platinum, gold, silica, or other metals.

26. The system of claim 22, wherein the abrasive surface includes an etched, knurled, and / or stippled surface.

27. The system of claim 22, wherein the abrasive surface is a micropatterned surface operable to improve emboli dissolution.

28. The system of claim 21 , the system further comprising a guidewire operable to guide the catheter, the guidewire contained within the at least one lumen.

29. The system of claim 28, wherein the magnetic field is operable to control a movement of the guidewire.

30. The system of claim 28, wherein the guidewire comprises a magnetic material.31 . The system of claim 30, wherein the magnetic material includes PtCo and / or NdBFe.

32. The system of claim 30, wherein the magnetic material increases a total magnetic mass of the catheter, thereby improving a maximum degree of deflection of the101105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center catheter and / or decreasing a strength of the magnetic field necessary to deflect the catheter.

33. The system of claim 21 , wherein the magnetic field is operable to selectively rotate the magnetic tip and / or selectively control a movement of the catheter.

34. The system of claim 31 , wherein the magnetic field is operable to cause the magnetic tip to rotate about the axis at a rotation rate of about 60 rpm to about 2,000 rpm.

35. The system of claim 34, wherein the rotation rate is about 200 rpm to about 2,000 rpm.

36. The system of claim 34, wherein the rotation rate is about 1 ,000 rpm to about 2,000 rpm.

37. The system of claim 34, wherein the rotation rate is about 200 rpm to about 500 rpm.

38. The system of claim 34, wherein the rotation rate is about 1 ,200 rpm.

39. The system of claim 34, wherein rotation of the magnetic tip stabilizes at the rotation rate.

40. The system of claim 21 , wherein the magnetic field is operable to steer the magnetic tip within the artery, cavity, vein, or blood vessel, thereby steering the catheter.

41. The system of claim 21 , the system further comprising a fluid source operable to provide a fluid to the at least one lumen.

42. The system of claim 41 , wherein the fluid includes one or more drugs, x-ray contrast agents, Von Willebrand factor, acids, neuroprotectants, DNAse, other therapeutic agents, and other diagnostic agents.

43. The system of claim 42, wherein the one or more drugs includes a thrombolytic.102105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center44. The system of claim 43, wherein the thrombolytic includes alteplase, Tenecteplase, urokinase, desmoteplase, reteplase, and / or streptokinase.

45. The system of claim 41 , wherein the fluid source provides a pressurized fluid through the at least one lumen, wherein the pressurized fluid rotates the magnetic tip.

46. The system of claim 21 , wherein the at least one lumen includes a guidewire lumen, an aspiration lumen, and a fluid delivery lumen.

47. The system of claim 46, wherein the guidewire lumen, the aspiration lumen, and the fluid delivery lumen are concentric lumens.

48. The system of claim 46, wherein the guidewire lumen, the aspiration lumen, and the fluid delivery lumen are side-by-side lumens.

49. The system of claim 46, wherein the aspiration lumen is operable to provide a vacuum force.

50. The system of claim 49, wherein the vacuum force causes the magnetic tip to rotate.51 . The system of claim 21 , wherein the magnetic tip is a distal magnetic bur.

52. The system of claim 21 , wherein the magnetic tip includes one or more fluid delivery ports.

53. The system of claim 52, wherein the one or more fluid delivery ports includes a distal fluid delivery port at a tip of the magnetic tip.

54. The system of claim 52, wherein the one or more fluid delivery ports includes one or more side delivery ports disposed on a circumferential surface of the magnetic tip.103105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center55. The system of claim 21 , wherein the magnetic tip includes one or more aspiration ports.

56. The system of claim 55, wherein the one or more aspiration ports include a distal aspiration port at a tip of the magnetic tip and / or one or more side aspiration ports disposed on a circumferential surface of the magnetic tip.

57. The system of claim 21 , wherein a rotation of the magnetic tip is operable to provide a vacuum pressure, thereby causing fluids to be vacuumed into the at least one lumen.

58. The system of claim 21 , the system further comprising a 3D localization subsystem.

59. The system of claim 58, wherein the 3D localization subsystem comprises a robotic arm.

60. The system of claim 58, wherein the 3D localization subsystem is a magnetic 3D localization subsystem.

61. The system of claim 60, wherein the magnetic 3D localization subsystem uses AC and / or DC fields.

62. The system of claim 61 , wherein the magnetic 3D localization subsystem is operable to locate the magnetic tip within 1 mm.

63. The system of claim 62, wherein the magnetic 3D localization subsystem includes a localization pad.

64. The system of claim 63, wherein the localization pad is radiotranslucent.

65. The system of claim 63, wherein the localization pad is operable to be installed under a patient table.104105119194.4PATENTAttorney Docket No. 104954-835903 Via Patent Center66. The system of claim 63, wherein the magnetic 3D localization subsystem generates a localization field over an occlusion site and surrounding blood vessels, cavities, arteries, and veins of a patient.

67. The system of claim 63, wherein the magnetic 3D localization subsystem further includes one or more localization coils.

68. The system of claim 67, wherein the localization pad and the one or more localization coils are compatible with the magnetic tip and the external magnet.

69. The system of claim 67, wherein the one or more localization coils have a diameter of less than about 0.3 mm.

70. The system of claim 60, wherein the magnetic 3D localization subsystem is operable to update a position of the magnetic tip in real-time within an accuracy threshold of about 1 mm.71 . The system of claim 60, wherein the magnetic 3D localization subsystem is not affected by biological impendence or susceptibility.

72. The system of claim 21 , wherein the catheter further comprises one or more 3D localization sensors.

73. The system of claim 72, wherein the one or more 3D localization sensors have at least five degrees of freedom.

74. The system of claim 72, wherein the one or more 3D localization sensors are operable to provide a real-time angulation and / or a real-time position of the magnetic tip.

75. The system of claim 21 , wherein the magnetic tip has a shape operable to break down a clot.

76. The system of claim 21 , wherein the magnetic tip includes helical grooves.105105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center77. The system of claim 21 , wherein the magnetic tip includes one or more wings.

78. The system of claim 77, wherein the one or more wings are evenly spaced.

79. The system of claim 21 , wherein the magnetic tip comprises a dome shape, a prolate shape, a cylindrical shape, a spherical shape, a cube shape, a cuboid shape, or a triangular prism shape.

80. The system of claim 79, wherein the dome shape increases in diameter from a distal end furthest from the catheter body to a proximal end, or wherein the dome shape increases in diameter from the proximal end to the distal end.

81. The system of claim 21 , wherein the magnetic tip includes one or more cutting edges.

82. The system of claim 81 , wherein the one or more cutting edges are disposed on a distal tip of the magnetic tip and / or a circumferential surface of the magnetic tip.

83. The system of claim 21 , wherein the magnetic tip has one or more teeth on a distal end furthest from the catheter body.

84. The system of claim 21 , wherein the magnetic tip has one or more teeth on a circumferential surface of the magnetic tip.

85. The system of claim 21 , wherein the magnetic tip is operable to mix a fluid as it rotates.

86. The system of claim 85, wherein the magnetic tip mixes the fluid outside of the magnetic tip and / or the fluid contained within the magnetic tip.

87. The system of claim 21 , wherein an applied torque on the magnetic tip corresponds to a distance between the magnetic tip and the external magnet.106105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center88. The system of claim 87, wherein a rotation speed of the magnetic tip corresponds to a rotation speed of the external magnet.

89. The system of claim 21 , wherein the magnetic tip has a diameter of about 1 mm to about 5 mm or about 2 mm to about 3 mm.

90. The system of claim 21 , wherein the magnetic tip comprises PtCo, SmCo, NdBFe, and / or bonded magnets.

91. The system of claim 21 , wherein the artery, vein, cavity, or blood vessel is located in an arm, leg, brain, heart, neck, torso, or any body part of a patient.

92. The system of claim 21 , wherein the system is used for atherectomies and / or thrombectomies.

93. The system of claim 21 , wherein the magnetic field is 50 mT or less.

94. The system of claim 21 , wherein the magnetic field is 30 mT or less.

95. The system of claim 21 , wherein a tip of the magnetic tip includes a radiopaque material and a body of the magnetic tip includes a radiotranslucent material.

96. The system of claim 95, wherein one or more proximal connectors include the radiopaque material.

97. The system of claim 96, wherein a fixed distance is maintained between the tip and the one or more proximal connectors.

98. The system of claim 97, the system further comprising an X-ray machine operable to locate the radiopaque material when the catheter is in use.

99. The system of claim 21 , wherein a circumferential surface of the magnetic tip includes an angled ribbon of radiopaque material.107105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center100. The system of claim 21 , wherein at least a portion of the magnetic tip includes a radiopaque material.

101. The system of claim 100, wherein the radiopaque material allows visualization of a rotation of the magnetic tip under a fluoroscope and / or another imaging system.

102. The system of claim 21 , wherein the magnetic field provides an off-axis magnetic force to the magnetic tip, thereby causing an orbital motion and / or an erratic motion, wherein the orbital motion and / or erratic motion is operable to breakdown or debulk a larger volume of the occlusion as compared to a non-orbital device.

103. The system of claim 102, wherein the orbital motion and / or the erratic motion promote stirring of a fluid within the catheter or outside of the catheter.

104. The system of claim 21 , wherein the magnetic tip has a tip comprising a rough surface.

105. The system of claim 21 , wherein the external magnet is cylindrical, octagonal, or another shape.

106. The system of claim 21 , wherein the external magnet comprises a high energy material.

107. The system of claim 106, wherein the high energy material is NdBFe.

108. The system of claim 21 , wherein the external magnet has a mass of about 10 kg to about 30 kg.

109. The system of claim 21 , wherein the external magnet is operable to be positioned in three dimensions around a patient.

110. The system of claim 21 , the system further comprising an external magnet assembly, the external magnet assembly comprising a robotic arm coupled to the external108105119194.4PATENTAttorney Docket No. 104954-835903 Via Patent Center magnet, the robotic arm configured to position the external magnet with respect to the catheter.

111. The system of claim 21 , wherein the external magnet comprises an electromagnet operable to generate temporal magnetic fields.

112. The system of claim 21 , wherein the magnetic tip has a selective surface.

113. The system of claim 112, wherein the selective surface is configured to convey fluids and / or shear the occlusion.

114. The system of claim 21 , the catheter further comprising a speed sensor disposed on or near the spindle and / or the magnetic tip, the speed sensor configured to measure a rotation speed of the magnetic tip.

115. A method for breaking down or clearing an occlusion in an artery, blood vessel, vein, or cavity, the method comprising: navigating a catheter comprising a rotatable magnetic tip to the occlusion; providing, via an external magnet, a magnetic field operable to rotate the rotatable magnetic tip; and breaking down and / or clearing the occlusion by grinding the occlusion with the rotatable magnetic tip.

116. The method of claim 115, wherein navigating the catheter comprises receiving a guidewire through at least one lumen of the catheter and steering the catheter along the guidewire.

117. The method of claim 115, the method further comprising providing one or more diagnostic and / or therapeutic agents to the occlusion via a fluid delivery lumen of the catheter.109105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center118. The method of claim 115, the method further comprising providing aspiration to an occlusion site of the occlusion by providing a vacuum pressure through an aspiration lumen of the catheter.

119. The method of claim 115, the method further comprising locating a position and / or angulation of the catheter in real-time.

120. A system for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the system comprising: a catheter comprising: a catheter body including at least one lumen defining an axis; a spindle attached to the catheter body; and a magnetic rotor rotatably mounted to the spindle; and an external magnet operable to generate a magnetic field.

121. The system of claim 120, wherein the magnetic rotor is a magnetic tip.

122. The system of claim 120, wherein the magnetic rotor includes a distal tip.

123. The system of claim 122, wherein the distal tip includes a cap configured to breakdown and / or debulk the occlusion.

124. The system of claim 120, wherein the magnetic rotor includes a bit to breakdown and / or debulk the occlusion.

125. A catheter for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the catheter comprising: a catheter body comprising: at least one lumen defining an axis; and a ball joint connector; and a magnetic tip assembly comprising: a magnetic tip holder comprising a ball operable to be received within the ball joint connector; and a magnetic tip coupled to the magnetic tip holder, no105119194.4PATENTAttorney Docket No. 104954-835903Via Patent Center wherein movement of the magnetic tip is operable to be controlled by an external magnetic field.

126. The catheter of claim 125, wherein the at least one lumen includes an inner lumen that extends through the magnetic tip assembly to a distal end of the magnetic tip.

127. The catheter of claim 125, wherein the at least one lumen further includes a localization sensor lumen.

128. The catheter of claim 127, further comprising a localization sensor contained within the localization sensor lumen.

129. A catheter for breaking down or clearing an occlusion in an artery, vein, blood vessel, or cavity, the catheter comprising: a catheter body having a longitudinal axis; and a magnetic tip rotatably coupled to the catheter body, the magnetic tip operable to rotate about the longitudinal axis.

130. The catheter of claim 129, wherein the magnetic tip rotates about the longitudinal axis when supplied an external magnetic field.

131. The catheter of claim 129, wherein the magnetic tip includes a shape and / or surface configured to grind the occlusion.

132. The catheter of claim 131 , wherein the surface includes an abrasive surface.

133. The catheter of claim 131 , wherein the shape and / or the surface is configured to break down the occlusion without the use of a thrombolytic and / or other therapeutic agent.

134. The catheter of claim 129, wherein the magnetic tip is configured to capture the occlusion. in105119194.4PATENTAttorney Docket No. 104954-835903 Via Patent Center135. The catheter of claim 134, wherein the magnetic tip is operable to rotate the captured occlusion.

136. The catheter of claim 135, further comprising a fluid delivery lumen operable to deliver a thrombolytic and / or other therapeutic agent.

137. The catheter of 136, wherein the thrombolytic and / or other therapeutic agent breaks down the occlusion as the occlusion is rotated by the magnetic tip.

138. The catheter of claim 134, wherein the magnetic tip includes a net.

139. The catheter of claim 129, further comprising at least one lumen.

140. The catheter of claim 139, wherein the at least one lumen is operable to receive a guidewire, deliver a fluid to the occlusion, and / or aspirate an occlusion site including the occlusion and / or a surrounding area.

141. The catheter of claim 139, wherein the at least one lumen includes a single lumen operable to receive a guidewire, deliver a fluid to the occlusion, and / or aspirate an occlusion site including the occlusion and / or a surrounding area.

142. The catheter of claim 139, wherein the at least one lumen includes a fluid delivery lumen, an aspiration lumen, and a guidewire lumen.112105119194.4

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