Thermal thrombectomy system and method

Abstract

The present disclosure relates to a thermal thrombectomy system and method. The thermal thrombectomy system can apply heat to a thrombus to soften and / or melt the thrombus, which may include one or more proteins and / or biopolymers of the thrombus, facilitating its removal. The thermal thrombectomy system can include a heating wire that can be navigated to the thrombus. A distal portion of the wire can apply heat to the thrombus while a proximal portion is insulated. The heating wire can include coils and / or other features to facilitate engagement with the thrombus.

Description

[Technical Field]

[0001] (cross reference) This application claims the benefit of priority to U.S. Provisional Application No. 63 / 520,214, filed August 17, 2023, and U.S. Provisional Application No. 63 / 481,900, filed January 27, 2023, which are incorporated herein by reference in their entireties. All applications for which domestic or foreign priority is identified in the Application Data Sheet filed herewith are incorporated herein by reference under 37 CFR 1.57.

[0002] The present disclosure relates to thrombus removal systems and methods. [Background technology]

[0003] The vascular system carries blood throughout the body. The vascular system includes arteries, which distribute oxygenated blood from the heart throughout the body, and veins, which return deoxygenated blood to the heart.

[0004] Thrombosis occurs when a blood clot (e.g., a blood clot) forms in a blood vessel, whether venous or arterial. A blood clot can restrict blood flow through a blood vessel. For example, deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein and restricts blood flow back toward the heart. DVT typically occurs in the lower leg, thigh, or pelvis, but can also occur in other parts of the body, such as the arm. DVT can also cause swelling, pain, discoloration, scaling, and / or ulcers. Furthermore, fragments of the blood clot (e.g., an embolus) can break off and travel through the bloodstream to the lungs, causing pulmonary embolism (PE), a potentially fatal condition. Summary of the Invention [Problem to be solved by the invention]

[0005] Thrombus can be removed by a thrombectomy procedure. The thrombectomy procedure may include navigating a guidewire through the vasculature with the aid of an imaging system (e.g., fluoroscopic imaging) and advancing it past the thrombus to a distal location. A catheter can be advanced along the guidewire through the thrombus, deploying (e.g., expanding) an expandable bag distal to the thrombus. The expandable bag can be retracted proximally to scrape the inner wall of the vessel, capturing the thrombus and depositing it into the catheter for removal. The surgeon performing the thrombectomy can make multiple passes with the expandable bag to remove the thrombus. Performing multiple passes can be time-consuming and frustrating. Furthermore, the likelihood of incurring damage to the vessel wall and / or valve increases with each pass. Multiple passes can increase the risk of vascular inflammation and re-thrombosis. Therefore, a thrombectomy solution is needed to reduce the number of passes required to remove a thrombus.

[0006] A thrombus may contain fibrin, red blood cells, platelets, white blood cells, and neutrophil extracellular traps. Over time, the thrombus accumulates more collagen and fibrin content. As more collagen accumulates, the thrombus becomes harder, and it may be difficult for guidewires, catheters, and / or expandable devices to pass through the thrombus. Attempts to pass a hardened thrombus can be time-consuming, frustrating, and / or result in damage to the vessel wall and / or valve. [Means for solving the problem]

[0007] The thermal thrombectomy systems and methods disclosed herein may address at least the above-mentioned problems. Thrombus (e.g., one or more proteins and / or biopolymers) may be softened and / or emulsified (e.g., melted, liquefied) by the thermal thrombectomy systems and methods disclosed herein. Softening and / or emulsifying the thrombus can facilitate penetration by wires, guidewires, catheters, cutting devices, and / or collection devices (e.g., expandable devices, capture devices). Softening or emulsifying the thrombus allows it to more easily separate from the vessel wall and endothelial cell layer. Softening or emulsifying the thrombus can help break down the thrombus into fragments that are more easily extracted using expandable capture devices, such as balloons, umbrellas, baskets, bags, scoops, and / or suction devices. Once the thrombus is softened or emulsified, an expandable device (e.g., a capture device) and / or aspiration device may extract the thrombus in a single pass or with fewer passes, facilitating a more efficient and convenient procedure and reducing the risk of damage to the vessel wall, vascular valves, vascular inflammation, and re-thrombosis. The thermal thrombectomy systems described herein may be used to remove both acute and chronic thrombi in both veins and arteries. For example, the thermal thrombectomy systems and methods described herein may insert (e.g., inject) a heating element into a chronic region of thrombus, which may emulsify and / or loosen the chronic region. The thermal thrombectomy systems and methods disclosed herein may facilitate localized removal of thrombus, which may preserve endothelial cells and valves. The thermal thrombectomy systems and methods disclosed herein may remove both chronic and acute thrombi. The thermal thrombectomy systems and methods disclosed herein may access all anatomical vascular locations (e.g., below the knee and smaller vessels). The thermal thrombectomy systems and methods disclosed herein may reduce blood loss. The thermal thrombectomy systems and methods disclosed herein may avoid systemic thrombolysis. The thermal thrombectomy systems disclosed herein may be disposable (e.g., console-less) or reusable.

[0008] In some variations, the thermal thrombectomy systems disclosed herein can include a heated wire (e.g., a heating element, a heated guidewire), which may also be referred to as a temperature-controlled wire (e.g., a temperature-controlled element, a temperature-controlled guidewire). The heated wire can be heated directly or indirectly using one or more energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, ultrasound, hot fluid, nuclei, and / or others. A distal portion of the heated wire can be configured to be positioned at the thrombus and apply heat to the thrombus to soften and / or emulsify the thrombus forming element. A proximal portion (e.g., a portion configured to be positioned away from the thrombus) can be insulated. The heated wire can be navigated to the thrombus, heated to a temperature sufficient to liquefy or at least soften the thrombus, inserted into the thrombus, and advanced through the thrombus to a distal location. Advancement through the thrombus using a heated wire can facilitate penetration compared to a non-heated wire. In some variations, the wire may penetrate the thrombus, which may include passing it to a distal location prior to heating. In some variations, an expandable device, which may also be heated, can be placed distal to the thrombus prior to heating the wire.

[0009] In some variations, the thermal thrombectomy systems disclosed herein may include an expandable device (e.g., a capture device), which may include at least a bag (e.g., mesh, abrasive, etc.), an inverted mesh, a mesh, a stent, an umbrella, a balloon, a basket, a funnel (e.g., a mesh funnel), a disk, and / or other device. The expandable device may be advanced along a guidewire, which may be a heated guidewire, to a location distal to the thrombus and deployed (e.g., expanded) to prevent fragments, such as emboli, of the thrombus from migrating through the bloodstream to other areas of the body, such as the lungs. The expandable device may be advanced along a guidewire, which may be a heated guidewire, to a location proximal to the thrombus and deployed (e.g., expanded) to prevent fragments, such as emboli, of the thrombus from migrating through the bloodstream to other areas of the body. In some variations, the expandable device may be heated and may include having a heated portion and another non-heated portion. For example, a distal portion of the expandable device, or a catheter delivering the expandable device, may be heated to facilitate passage of the thrombus. If heated, the expandable device may be heated using at least the techniques described herein. The expandable device can be deployed by a catheter positioned distal to the thrombus and / or other occlusion, thus allowing the heated guidewire to be removed after emulsification.

[0010] In some variations, the thermal thrombectomy systems disclosed herein may include a cutting device (e.g., a thermal device), which may include at least a coil, lasso, corkscrew, drill, wire, spatula, auger, tapered wire drill, blade, knife, contraction coil, vitrectomy probe, ultrasonic cutter, expandable scrubber (e.g., wire), umbrella, inverted mesh, and / or others. The cutting device, which may also be referred to as a scraping device and / or slicing device, may be advanced to the thrombus along a guidewire, which may be a heated guidewire. In some variations, the cutting device may be deployed by a catheter positioned distal to the thrombus and / or other occlusion, which may be after the heated wire is removed. The cutting device may be manipulated to disrupt the thrombus. For example, the cutting device may be rotated, moved distally, moved proximally, vibrated, and / or otherwise manipulated. The cutting device may include mechanical, electrical, thermal, light-based, ultrasonic, and / or other features. In some variations, the wire, which may be a heated guidewire, may include any of the features described above (e.g., a coil, a corkscrew, a drill, a wire, a spatula, an auger, a tapered wire drill, etc.). The cutting device may be heated, and the heating may include having heated and non-heated portions to facilitate disruption of the thrombus. In some variations, the cutting device may be used without an expandable device and / or a separate guidewire. In some variations, the cutting device may have an oscillator and / or a reciprocator to further facilitate cutting or ablating the desired tissue.

[0011] In some variations, the thermal thrombus removal systems disclosed herein may include an aspiration device, which may include at least a wall vacuum, a Venturi vacuum, an auger, a syringe, an oscillating vacuum with a return filter, and / or other features. In some variations, the aspiration device may aspirate thrombi from a blood vessel. In some variations, the aspiration device may be heated, and the heating may include having heated and non-heated portions. For example, the aspiration device may include a heatable port. In some variations, the heated port of the aspiration device can be advanced distally to emulsify and aspirate thrombi and / or other obstructions.

[0012] In some aspects, the technology described herein relates to a thermal device configured to apply heat to a thrombus, the thermal device including an outer tube including a distal portion, a heating element disposed in the distal portion of the outer tube, and one or more conduits configured to apply an electric current to the heating element to increase the temperature of the heating element and apply heat to the thrombus.

[0013] In some aspects, the technology described herein relates to a thermal device further including an inner tube disposed within the outer tube and configured to receive a guidewire, the thermal device configured to be advanced over the guidewire.

[0014] In some aspects, the technology described herein relates to a thermal device wherein the heating element comprises a loop.

[0015] In some aspects, the technology described herein relates to a thermal device wherein the loop comprises a nickel-titanium alloy.

[0016] In some aspects, the technology described herein relates to a thermal device wherein the loop comprises a tube.

[0017] In some aspects, the technology described herein relates to a thermal device wherein the loop comprises a hollow lumen, and wherein the thermal device further comprises a temperature sensor disposed within the hollow lumen.

[0018] In some aspects, the technology described herein relates to a thermal device further including a controller configured to modulate the current applied to the heating element based on a temperature sensed by the temperature sensor.

[0019] In some aspects, the technology described herein relates to a thermal device further including a temperature sensor.

[0020] In some aspects, the technology described herein relates to a thermal device further comprising an electrode for sensing leakage current.

[0021] In some aspects, the technology described herein relates to thermal devices in which the electrodes are markers for visualization.

[0022] In some aspects, the technology described herein relates to a thermal device further comprising an expandable device configured to be expanded proximal to said thrombus.

[0023] In some aspects, the technology described herein relates to thermal devices, wherein the expandable device comprises a balloon.

[0024] In some aspects, the technology described herein relates to a thermal device, wherein the expandable device includes a lumen configured for the outer tube to be advanced through.

[0025] In some aspects, the technology described herein relates to a thermal thrombus removal device configured to apply heat to a thrombus, the thermal thrombus removal device including an expandable assembly including an expandable device, the expandable assembly configured to be expanded proximal to a thrombus, and a thermal assembly including a thermal heating element, the thermal assembly configured to be advanced distally over a guidewire and exit the expandable assembly to apply heat to the thrombus with the heating element.

[0026] In some aspects, the technology described herein relates to a thermal thrombus removal device, wherein the thermal assembly includes one or more conduits configured to apply an electric current to the heating element to increase the temperature of the heating element.

[0027] In some aspects, the technology described herein relates to a thermal thrombectomy device, wherein the expandable device is a balloon.

[0028] In some aspects, the technology described herein relates to a thermal thrombectomy device, wherein the heating element comprises a loop.

[0029] In some aspects, the technology described herein relates to a thermal thrombectomy device, wherein the loop comprises a tube.

[0030] In some aspects, the technology described herein relates to a thermal thrombectomy device, wherein the loop comprises a hollow lumen, and wherein the thermal thrombectomy device comprises a temperature sensor disposed within the hollow lumen.

[0031] In some aspects, the technology described herein relates to a thermal thrombectomy device further including a controller configured to modulate the current applied to the heating element based on the temperature sensed by the temperature sensor.

[0032] In some aspects, the technology described herein relates to a thermal thrombectomy device that further includes a temperature sensor.

[0033] In some aspects, the technology described herein relates to a thermal thrombectomy device that further includes an electrode for sensing leakage current.

[0034] In some aspects, the technology described herein relates to a method of crossing a thrombus, the method comprising advancing a thermal assembly over a guidewire to the thrombus and applying an electric current to a heating element of the thermal assembly to heat the thrombus.

[0035] In some aspects, the techniques described herein relate to methods further including advancing an expandable device over a guidewire adjacent to the thrombus and expanding the expandable device.

[0036] In some aspects, the technology described herein relates to methods wherein the expandable device comprises a balloon.

[0037] In some variations, disclosed herein is a thermal thrombus removal device capable of applying heat to a thrombus in a patient's blood vessel. The device can include a wire. The device can include an insulating layer disposed over at least a proximal portion of the wire to protect the patient's anatomy from heat. The device can include a temperature modulation unit capable of applying energy to the wire to increase the temperature of the wire. The wire can be navigated through the patient's vasculature to apply heat to the thrombus so that it softens or emulsifies (e.g., melts).

[0038] In some variations, the wire may include a nickel and titanium alloy.

[0039] In some variations, the insulating layer may be a sheath.

[0040] In some variations, the device may include a power source. The power source may be a battery. In some variations, the wire is a guidewire.

[0041] In some variations, the energy applied by the temperature modulation unit may be electrical.

[0042] In some variations, the temperature modulation unit is capable of increasing the temperature of the wire to heat collagen in the thrombus to above 60° C. In some variations, the temperature modulation unit is capable of increasing the temperature of the wire to heat collagen in the thrombus to above 60° C.

[0043] In some variations, the temperature modulation unit can increase the temperature of the wire to heat the collagen of the thrombus to 70°C. In some variations, the temperature modulation unit can increase the temperature of the wire to heat the collagen of the thrombus to 80°C.

[0044] In some variations, the temperature modulation unit can increase the temperature of the wire to between 60° C. and 80° C. In some variations, the temperature modulation unit can increase the temperature of the wire to above 60° C.

[0045] In some variations, the temperature modulation unit is capable of increasing the temperature of the wire to 70° C. In some variations, the temperature modulation unit is capable of increasing the temperature of the wire to 80° C. or greater.

[0046] In some variations, the wire may include a coil.

[0047] In some variations, disclosed herein is a thermal thrombectomy system capable of applying heat to a thrombus in a patient's blood vessel. The system can include a wire. The system can include a layer of material surrounding a proximal portion of the wire. The system can include a power source capable of applying energy to the wire to increase the temperature of the wire. The wire can be navigated through the patient's vasculature to apply heat to the thrombus.

[0048] In some variations, the wire may be a guidewire.

[0049] In some variations, the layer of material can be a sheath.

[0050] In some variations, the layer of material can insulate the patient's anatomy from the heat of the wire.

[0051] In some variations, the wire may include a nickel and titanium alloy.

[0052] In some variations, the power source may be a battery. In some variations, the electrical insulator comprises polytetrafluoroethylene.

[0053] In some variations, the energy applied by the power source may be electricity.

[0054] In some variations, the power source can increase the temperature of the wire to heat the thrombus to between 60 and 200° C. In some variations, the power source can increase the temperature of the wire to heat the thrombus to between 60 and 200° C.

[0055] In some variations, the power source can increase the temperature of the wire to heat the thrombus to 70° C. In some variations, the power source can increase the temperature of the wire to heat the thrombus to 80° C.

[0056] In some variations, the power source can increase the temperature of the wire to between 60 and 75°C. In some variations, the power source can increase the temperature of the wire to between 60 and 80°C. In some variations, the power source can increase the temperature of the wire to between 60 and 120°C.

[0057] In some variations, the power supply is capable of raising the temperature of the wire to 70 degrees Celsius. In some variations, the power supply is capable of raising the temperature of the wire to 80 degrees Celsius.

[0058] In some variations, the wire may include a coil that is disposed within the layer of material and that may be deployed when in proximity to the thrombus.

[0059] In some variations, the outer periphery of the coil may be insulated.

[0060] In some variations, the wire may include two coils that may be overlapped with one another.

[0061] In some variations, the wire may include a coil drill.

[0062] In some variations, the wire may include a lasso, hi some variations, the wire may include a loop.

[0063] In some variations, the wire may include a coil and a straight portion disposed through the coil.

[0064] In some variations, the wire may include an outer coil and an inner coil that may be joined together at a distal end, the inner coil being heatable and the outer coil being non-heatable.

[0065] In some variations, the wire may include an outer coil and an inner coil that may be joined together at a distal end. The outer coil may be insulated.

[0066] In some variations, a method of performing thrombectomy is disclosed herein. The method can include navigating a wire through a patient's vasculature to a thrombus. The method can include applying an energy source to the wire to increase the temperature of the wire. The method can include advancing the wire through the thrombus.

[0067] In some variations, the method can include advancing an expandable member along the wire distal to the thrombus.

[0068] In some variations, the method may include advancing a cutting device along the guidewire and into the thrombus.

[0069] In some variations, the method may include rotating the cutting device.

[0070] In some variations, the cutting device may include an auger.

[0071] In some variations, the method may include aspirating the thrombus.

[0072] In some variations, a method of performing thrombectomy is disclosed herein. The method can include navigating a wire within a sheath through a patient's vasculature to a thrombus. The method can include applying an energy source to the wire to increase the temperature of the wire. The method can include advancing the sheath and the wire into the thrombus. The method can include disengaging a distal portion of the wire from the sheath to allow the wire to self-expand. The method can include retracting the wire.

[0073] In some variations, the wire self-expands into a coil and the method may include rotating the coil.

[0074] In some variations, the method may include aspirating the thrombus.

[0075] In some variations, a method of performing thrombectomy is disclosed herein. The method can include navigating a wire within a sheath through a patient's vasculature to a thrombus. The method can include applying an energy source to the wire to increase a temperature of the wire. The method can include removing a distal portion of the wire from the sheath to allow the wire to self-expand. The method can include advancing the wire into the thrombus. The method can include retracting the wire.

[0076] In some variations, the wire self-expands into a coil and the method may include rotating the coil.

[0077] In some variations, the method may include aspirating the thrombus.

[0078] In some variations, a thermal thrombus removal device is disclosed herein. The device can include a catheter that can include a port and a mount. The device can include a wire extending through the port. The wire can include an inner portion inside the catheter and an outer portion forming a lasso disposed on the exterior of the catheter. An end of the outer portion can be coupled to the mount. The device can include a power source that can apply an electric current to electrical contacts disposed on the port and mount, increasing the temperature of the wire and softening or emulsifying (e.g., melting) the thrombus. The device can include a cable extending through the catheter. The inner portion of the wire can be coupled to the cable. The cable can be rotated to further extend the wire outside the catheter and increase the diameter of the lasso.

[0079] In some variations, the technology described herein relates to a thermal thrombus removal system configured to remove a thrombus from a patient's blood vessel, the system including a capture device including a bag and a loop at an opening to the bag configured to apply heat to the thrombus to heat it, the capture device configured to retract proximally to bring the loop into interfacial contact with the thrombus to detach the thrombus from the wall of the blood vessel, and the bag configured to capture the detached thrombus.

[0080] In some variations, the technology described herein relates to a system further including a catheter, wherein the capture device is configured to be deployed distally to the thrombus through the catheter.

[0081] In some variations, the technology described herein relates to a system further including a heating wire configured to penetrate the thrombus and facilitate distal positioning of the capture device relative to the thrombus.

[0082] In some variations, the technology described herein relates to a system that further includes an expandable device having a balloon configured to expand proximal to the thrombus.

[0083] In some variations, the technology described herein relates to systems in which the temperature is between 60°C and 200°C.

[0084] In some variations, the technology described herein relates to systems where the temperature is about 80° C. or higher.

[0085] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 80°C.

[0086] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 70°C.

[0087] In some variations, the technology described herein relates to a system that further includes a sheath configured to be disposed over the capture device.

[0088] In some variations, the technology described herein relates to systems in which the loop includes a diameter that is larger than the diameter of the blood vessel.

[0089] In some variations, the technology described herein relates to a system further including a suction device configured to aspirate the thrombus.

[0090] In some variations, the technology described herein relates to a system wherein the suction device includes a mouth configured to be heated.

[0091] In some variations, the technology described herein relates to a system that further includes a temperature sensor configured to sense a temperature within the blood vessel.

[0092] In some variations, the technology described herein relates to a system configured to control the temperature of a loop based on a sensed temperature within the blood vessel.

[0093] In some variations, the technology described herein relates to a method of performing thrombus removal, the method including the steps of: positioning a capture device distal to a thrombus in a blood vessel; expanding a bag of the capture device; heating a loop positioned at a proximal opening in the bag to a specific temperature; retracting the capture device proximally to bring the loop into interfacial contact with the thrombus and detach the thrombus from the wall of the blood vessel; capturing the thrombus within the bag; and retracting the capture device proximally with the thrombus in the bag to remove the thrombus from the patient.

[0094] In some variations, the techniques described herein relate to methods further comprising the step of penetrating the thrombus with a heated wire.

[0095] In some variations, the technology described herein relates to methods in which the temperature is between 60 and 200°C.

[0096] In some variations, the technology described herein relates to methods where the temperature is 80° C. or higher.

[0097] In some variations, the techniques described herein relate to methods in which the temperature is between 60°C and 80°C.

[0098] In some variations, the technology described herein relates to methods where the temperature is between 60°C and 70°C.

[0099] In some variations, the techniques described herein relate to methods further comprising the step of aspirating the thrombus with a suction device.

[0100] In some variations, the technology described herein relates to methods further comprising the step of heating the mouth of the suction device.

[0101] In some variations, the techniques described herein relate to methods further including sensing a temperature within the blood vessel and controlling the temperature of the loop based on the sensed temperature.

[0102] In some variations, the technology described herein relates to a thermal thrombus removal system configured to remove a thrombus from a patient's blood vessel, the system including an aspiration device including a mouth configured to be heated to a temperature that softens or emulsifies the thrombus, the aspiration device configured to advance distally into interface contact with the thrombus and aspirate the thrombus.

[0103] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 200°C.

[0104] In some variations, the technology described herein relates to systems where the temperature is about 80° C. or higher.

[0105] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 80°C.

[0106] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 70°C.

[0107] In some variations, the technology described herein relates to a thermal thrombus removal system configured to remove a thrombus from a patient's blood vessel, the system including a capture device including a bag and a cutting device including a loop configured to be heated to a temperature that softens or emulsifies a thrombus within the blood vessel, the capture device and the cutting device configured to be positioned distal to the thrombus and retracted proximally to bring the loop into interfacial contact with the thrombus, detaching the thrombus from the wall of the blood vessel, and capturing the detached thrombus within the bag.

[0108] In some variations, the technology described herein relates to a system further including a catheter, wherein the capturing device and the cutting device are configured to be deployed distally to the thrombus through the catheter.

[0109] In some variations, the technology described herein relates to a system further including a heating wire configured to penetrate the thrombus and facilitate distal positioning of the capture device relative to the thrombus.

[0110] In some variations, the technology described herein relates to systems in which the distal end of the capturing device or the distal end of the cutting device includes a heating element configured to penetrate the thrombus and facilitate distal positioning of the capturing device and the cutting device relative to the thrombus.

[0111] In some variations, the technology described herein relates to a system wherein the bag comprises a mesh.

[0112] In some variations, the technology described herein relates to systems where the temperature is 80° C. or higher.

[0113] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 80°C.

[0114] In some variations, the technology described herein relates to systems where the temperature is between 60°C and 70°C.

[0115] In some variations, the technology described herein relates to a system that further includes a sheath configured to be disposed over the capture device.

[0116] In some variations, the technology described herein relates to a system further including a temperature sensor configured to sense a temperature within the blood vessel, the system configured to control the temperature of the loop based on the sensed temperature within the blood vessel.

[0117] In some variations, the technology described herein relates to a system in which the capturing device and the cutting device are coupled together.

[0118] In some variations, the technology described herein relates to a system in which an extension boom extends from a proximal opening into the bag to the distal end of the bag.

[0119] In some variations, the technology described herein relates to a method of performing thrombus removal, the method including the steps of positioning a capture device and a cutting device distal to a thrombus in a blood vessel, expanding a bag of the capture device, heating a loop of the cutting device to a specific temperature, retracting the cutting device proximally to bring the loop into interfacial contact with the thrombus and detach the thrombus from the wall of the blood vessel, capturing the thrombus within the bag, and retracting the cutting device and capture device proximally with the thrombus in the bag to remove the thrombus from the patient.

[0120] In some variations, the techniques described herein relate to methods further comprising the step of penetrating the thrombus with a heated wire.

[0121] In some variations, the technology described herein relates to methods in which the temperature is between 60 and 200°C.

[0122] In some variations, the technology described herein relates to methods where the temperature is 80° C. or higher.

[0123] In some variations, the technology described herein relates to methods where the temperature is between 60°C and 80°C.

[0124] In some variations, the technology described herein relates to methods where the temperature is between 60°C and 70°C.

[0125] In some variations, the techniques described herein relate to methods further comprising the step of aspirating the thrombus with a suction device.

[0126] In some variations, the technology described herein relates to methods further comprising the step of heating the mouth of the suction device.

[0127] In some variations, the techniques described herein relate to methods further including sensing a temperature within the blood vessel and controlling the temperature of the loop based on the sensed temperature.

[0128] In some variations, the technology described herein relates to a thrombus removal system that includes a recessed surface configured to deploy to engage a thrombus, and a conduit configured to provide energy to the recessed surface to heat the recessed surface to a particular temperature and soften or emulsify the thrombus.

[0129] In some variations, the technology described herein relates to a thermal thrombus removal system, the system including a member and a temperature modulation unit configured to apply energy to the member to heat the member to a particular temperature, the member being configured to be navigated through a blood vessel to apply heat to a thrombus.

[0130] In some variations, the technology described herein relates to a system in which the member includes a wire.

[0131] In some variations, the technology described herein relates to a system in which the energy is an electric current.

[0132] In some variations, the technology described herein relates to systems in which the temperature is between 60°C and 200°C.

[0133] In some variations, the technology described herein relates to a thermal thrombus removal system, the system including an expandable device including one or more heating elements and a temperature modulation unit configured to apply energy to the one or more heating elements to heat the one or more elements to a particular temperature, wherein the expandable device is configured to be retracted proximally, causing the one or more heating elements to apply heat to the thrombus.

[0134] In some variations, the technology described herein relates to a system in which the expandable device includes an expandable bag configured to capture the thrombus.

[0135] In some variations, the technology described herein relates to systems in which the energy is an electric current.

[0136] In some variations, the technology described herein relates to systems where the temperature is 60° C. or higher.

[0137] In some variations, the technology described herein relates to a method of performing thrombus removal, the method including expanding an expandable device distal to a thrombus, applying energy to one or more heating elements of the expandable device to heat the one or more elements to a particular temperature, retracting the expandable device to bring the one or more heating elements into interfacial contact with the thrombus, and capturing the thrombus within the expandable device.

[0138] In some variations, the technology described herein relates to methods wherein the expandable device includes an expandable bag configured to capture the thrombus.

[0139] In some variations, the technology described herein relates to methods wherein the energy is an electric current.

[0140] In some variations, the technology described herein relates to methods where the temperature is 60° C. or higher.

[0141] Neither the foregoing summary nor the following detailed description is intended to limit or define the scope of protection. The scope of protection is defined by the claims. Furthermore, reference is made herein to removing a blood clot from a vein. After reviewing this disclosure in its entirety, one skilled in the art will understand that the systems and methods described herein may also be applied to removing a blood clot from an artery. Additionally, the systems and methods described herein may be used to remove other blockages from the body. [Brief explanation of the drawings]

[0142] The above and other features of the embodiments disclosed herein are described below with reference to the drawings of the embodiments. The illustrated embodiments are intended to illustrate, but not to limit, the scope of protection. Various features of different disclosed embodiments can be combined to form further embodiments that are part of this disclosure.

[0143] [Figure 1] FIG. 1A shows the venous system of the limb.

[0144] FIG. 1B shows a vein with normal blood flow.

[0145] FIG. 1C shows a vein with a partial occlusion.

[0146] FIG. 1D shows a vein with a complete occlusion.

[0147] [Figure 2] FIG. 2A shows the venous system of the limb.

[0148] Figure 2B shows a vein with normal blood flow.

[0149] FIG. 2C shows a vein with early thrombus formation.

[0150] FIG. 2D shows a vein with a thrombus.

[0151] FIG. 2E shows the disintegration of the thrombotic embolus.

[0152] [Figure 3] FIG. 3A shows the venous system of the limb.

[0153] Figure 3B shows a blood clot in a vein of the venous system causing swelling.

[0154] [Figure 4] A table showing the changes in thrombus over time is shown.

[0155] [Figure 5] FIG. 5A shows an acute thrombus.

[0156] FIG. 5B shows a chronic thrombus.

[0157] [Figure 6] 1 shows a thrombus placed in a vein.

[0158] [Figure 7] 7A and 7B show graphs illustrating the glass transition temperature of collagen in thrombi and / or other thrombus-forming elements.

[0159] [Figure 8] 1 shows a thermal thrombectomy system.

[0160] [Figure 9] 9A-9D illustrate a method of using the thermal thrombectomy system.

[0161] [Figure 10A] 1 illustrates a method of using a thermal thrombectomy system. [Figure 10B] 1 illustrates a method of using a thermal thrombectomy system. [Figure 10C] 1 illustrates a method of using a thermal thrombectomy system. [Figure 10D] 1 illustrates a method of using a thermal thrombectomy system. [Figure 10E] 1 illustrates a method of using a thermal thrombectomy system.

[0162] [Figure 11] 1 shows an expandable device that can impede the distal migration of a thrombus or its fragments.

[0163] [Figure 12] 1 shows an expandable device that can impede the distal migration of a thrombus or its fragments.

[0164] [Figure 13] 13A-13C illustrate a method of using a thermal thrombectomy system having a wire with a coil.

[0165] [Figure 14] 14A-14C illustrate a method of using a thermal thrombectomy system having a wire with a tapered coil.

[0166] [Figure 15]10 illustrates a method of using a thermal thrombectomy system having a wire with a coil.

[0167] [Figure 16] 16A and 16B show a cutting device having a spiral with a flat wire.

[0168] [Figure 17] 1 shows a cutting device with a variable scrubber.

[0169] [Figure 18] 1 shows a cutting device having a spiral opening and a suction opening.

[0170] [Figure 19] 19A and 19B show a suction device.

[0171] [Figure 20] 1 shows a cross-sectional view of a suction device.

[0172] [Figure 21A] 1 shows a thermal thrombectomy system.

[0173] [Figure 21B] 1 shows a dual coil for the wire of a thermal thrombectomy system.

[0174] [Figure 21C] 1 shows a dual coil for the wire of a thermal thrombectomy system.

[0175] [Figure 22] 22A and 22B illustrate a method of using the thermal thrombectomy system.

[0176] [Figure 23] 1 shows a sheath and wire with a coil for a thermal thrombectomy system.

[0177] [Figure 24]1 shows a sheath and wire with a lasso for a thermal thrombectomy system.

[0178] [Figure 25] 1 shows a wire with a coil for a thermal thrombectomy system.

[0179] [Figure 26] 1 shows a wire with a coil for a thermal thrombectomy system.

[0180] [Figure 27] 27A and 27B show a wire with dual coils for a thermal thrombectomy system.

[0181] [Figure 28] 1 shows a cutting device with grooves and wires for a thermal thrombectomy system.

[0182] [Figure 29A] 1 shows a thermal thrombectomy system with a variable lasso. [Figure 29B] 1 shows a thermal thrombectomy system with a variable lasso. [Figure 29C] 1 shows a thermal thrombectomy system with a variable lasso. [Figure 29D] 1 shows a thermal thrombectomy system with a variable lasso. [Figure 29E] 1 shows a thermal thrombectomy system with a variable lasso.

[0183] [Figure 30A] A cross-sectional view of a vein is shown. [Figure 30B] A cross-sectional view of a vein is shown. [Figure 30C] A cross-sectional view of a vein is shown. [Figure 30D] A cross-sectional view of a vein is shown. [Figure 30E] A cross-sectional view of a vein is shown. [Figure 30F] A cross-sectional view of a vein is shown.

[0184] [Figure 30G] 1 shows a cross-sectional view of a chronic thrombus in a vein.

[0185] [Figure 31A] A heating element (eg, a heating wire) is shown traversing the thrombus. [Figure 31B] A heating element (eg, a heating wire) is shown traversing the thrombus. [Figure 31C] A heating element (eg, a heating wire) is shown traversing the thrombus.

[0186] [Figure 31D] 1 illustrates deployment of a capture device (e.g., an expandable device). [Figure 31E] 1 illustrates deployment of a capture device (e.g., an expandable device). [Figure 31F] 1 illustrates deployment of a capture device (e.g., an expandable device).

[0187] [Figure 31G] 13 shows retraction of the capture device to capture the thrombus. [Figure 31H] 13 shows retraction of the capture device to capture the thrombus. [Figure 31I] 13 shows retraction of the capture device to capture the thrombus.

[0188] [Figure 31J] 1 shows the removal of a thrombus by a capture device. [Figure 31K] 1 shows the removal of a thrombus by a capture device. [Figure 31L] 1 shows the removal of a thrombus by a capture device.

[0189] [Figure 31M] Shown is a vein with a removed thrombus.

[0190] [Figure 31N] 1 shows the removal of the thrombus through the vein and away from the collection site.

[0191] [Figure 31O] 10 shows the removal of the thrombus and capture device from the patient through the opening.

[0192] [Figure 32A] 13 shows the positioning of a capture device distal to the thrombus. [Figure 32B] 13 shows the positioning of a capture device distal to the thrombus.

[0193] [Figure 32C] 13 shows deployment of the capture device with retraction of the sheath. [Figure 32D] 13 shows deployment of the capture device with retraction of the sheath. [Figure 32E] 13 shows deployment of the capture device with retraction of the sheath.

[0194] [Figure 32F] 13 shows retraction of the capture device to capture the thrombus. [Figure 32G] 13 shows retraction of the capture device to capture the thrombus. [Figure 32H] 13 shows retraction of the capture device to capture the thrombus.

[0195] [Figure 33A] 13 shows the retraction of a capture device having an outer diameter larger than the vessel diameter. [Figure 33B] 13 shows the retraction of a capture device having an outer diameter larger than the vessel diameter. [Figure 33C] 13 shows the retraction of a capture device having an outer diameter larger than the vessel diameter.

[0196] [Figure 34A] 10 shows a thrombus trapped within the capture device retracting into the mouth of the catheter. [Figure 34B] 10 shows a thrombus trapped within the capture device retracting into the mouth of the catheter.

[0197] [Figure 34C]10 shows a thrombus captured within the capture device retracting into the heated port of the catheter. [Figure 34D] 10 shows a thrombus captured within the capture device retracting into the heated port of the catheter. [Figure 34E] 10 shows a thrombus captured within the capture device retracting into the heated port of the catheter. [Figure 34F] 10 shows a thrombus captured within the capture device retracting into the heated port of the catheter. [Figure 34G] 10 shows a thrombus captured within the capture device retracting into the heated port of the catheter. [Figure 34H] 10 shows a thrombus captured within the capture device retracting into the heated port of the catheter.

[0198] [Figure 35A] 10 shows the suction of thrombus through the advancing heated port of the catheter. [Figure 35B] 10 shows the suction of thrombus through the advancing heated port of the catheter. [Figure 35C] 10 shows the suction of thrombus through the advancing heated port of the catheter. [Figure 35D] 10 shows the suction of thrombus through the advancing heated port of the catheter. [Figure 35E] 10 shows the suction of thrombus through the advancing heated port of the catheter. [Figure 35F] 10 shows the suction of thrombus through the advancing heated port of the catheter.

[0199] [Figure 36] 1 shows a system for emulsifying and aspirating thrombus.

[0200] [Figure 37] Shows the device interfaces of the system.

[0201] [Figure 38] 1 shows a thermal controller system.

[0202] [Figure 39A] 1 shows a system having a capture device (eg, an expandable device) and a heating loop (eg, a thermal device, a cutting device) deployable from a catheter.

[0203] [Figure 39B] 39B shows a cross-sectional view of the system shown in FIG. 39A.

[0204] [Figure 39C] 1 shows a cross section of a thermal device.

[0205] [Figure 39D] 1 shows a cross section of a thermal device with exemplary dimensions.

[0206] [Figure 39E] 1 shows a portion of a thermal device without an outer casing.

[0207] [Figure 39F] 1 shows a portion of a thermal device within an outer casing.

[0208] [Figure 40A] A thermal device (e.g., a cutting device) is shown. [Figure 40B] A thermal device (e.g., a cutting device) is shown. [Figure 40C] A thermal device (e.g., a cutting device) is shown.

[0209] [Figure 41] FIG. 41A shows a thermal thrombectomy system.

[0210] FIG. 41B shows a cross-sectional view of the thermal thrombectomy system of FIG. 41A.

[0211] [Figure 42] FIG. 42A shows a thermal thrombectomy system.

[0212] FIG. 42B shows a cross-sectional view of the thermal thrombectomy system of FIG. 42A.

[0213] [Figure 43] FIG. 43A shows a thermal thrombectomy system.

[0214] FIG. 43B shows a cross-sectional view of the thermal thrombectomy system of FIG. 43A.

[0215] [Figure 44] FIG. 44A shows a thermal thrombectomy system.

[0216] FIG. 44B shows a cross-sectional view of the thermal thrombectomy system of FIG. 44A.

[0217] [Figure 45] 1 illustrates a capture device (e.g., an expandable device).

[0218] [Figure 46] Figures 46A-46F show the emulsification of the thrombus during the test.

[0219] [Figure 47] Shown is a distal end capable of crossing and / or coring thrombus and / or other occlusions. [Figure 48A] Shown is a distal end capable of crossing and / or coring thrombus and / or other occlusions. [Figure 48B] Shown is a distal end capable of crossing and / or coring thrombus and / or other occlusions. [Figure 49] Shown is a distal end capable of crossing and / or coring thrombus and / or other occlusions. [Figure 50] Shown is a distal end capable of crossing and / or coring thrombus and / or other occlusions. [Figure 51] Shown is a distal end capable of crossing and / or coring thrombus and / or other occlusions.

[0220] [Figure 52] 1 shows a thermal thrombectomy system.

[0221] [Figure 53A] 1 shows a handpiece for a thermal thrombectomy system.

[0222] [Figure 53B] 1 shows a thermal assembly of a thermal thrombectomy system.

[0223] [Figure 53C] 1 shows the connector of the thermal assembly.

[0224] [Figure 53D] The distal end of the thermal assembly is shown with the guidewire extending therethrough.

[0225] [Figure 53E] The distal end of the thermal assembly is shown with the guidewire retracted.

[0226] [Figure 53F] 1 shows the internal features of the thermal assembly.

[0227] [Figure 54A] 1 shows an anchoring assembly of a thermal thrombectomy system.

[0228] [Figure 54B] 1 illustrates a connector of the anchoring assembly.

[0229] [Figure 54C] 10 illustrates an expandable device (eg, balloon) of the anchoring assembly.

[0230] [Figure 54D] 1 shows a cross section of an expandable device (eg, balloon) of an anchoring assembly.

[0231] [Figure 55A] 10 shows the heating element of the thermal assembly being deployed through the inside of the sheath of the anchoring assembly.

[0232] [Figure 55B] 10 shows the heating element of the thermal assembly deployed through the inside of the sheath of the anchoring assembly.

[0233] [Figure 55C] 10 shows the tubing of the thermal assembly placed through the connector of the anchoring assembly. DETAILED DESCRIPTION OF THE INVENTION

[0234] Although specific embodiments and examples are described below, the present disclosure extends beyond the specifically disclosed embodiments and / or uses, as well as obvious modifications and equivalents thereof. Accordingly, it is intended that the scope of the present disclosure should not be limited by any particular embodiment described below. Furthermore, the present disclosure describes many embodiments in terms of veins and arteries, and systems and methods described in relation to veins can be applied to arteries, and systems and methods described in relation to arteries can be applied to veins.

[0235] 1A shows a human limb (e.g., leg, arm) 100. Limb 100 includes a venous system 102 that returns deoxygenated blood from limb 100 to the heart.

[0236] FIG. 1B shows a cross-section of a portion of a vein 104 of a venous system 102 having normal blood flow. The vein 104 includes a flow path 106 for deoxygenated blood bounded by a wall 118 of the vein 104. A thrombus 108 can develop within the vein 104 and partially restrict (e.g., obstruct, occlude, etc.) blood flow through the blood vessel 106, as shown in FIG. 1C. The thrombus 108 can form on the wall 118 of the vein 104, which may include a valve. The wall 118 may form along the wall 118 for a variety of reasons, which may include injury to the wall 118, inactivity, diet, and / or other reasons. The thrombus 108 can grow in size to completely block (e.g., obstruct, occlude, etc.) blood flow through the flow path 106, as shown in FIG. 1D. The obstruction of blood flow can also cause swelling, pain, and / or discoloration of the limb 100. Removing the blood clot can alleviate the patient's aforementioned symptoms and can prevent or at least delay the onset of further symptoms.

[0237] 2A shows a human limb (e.g., leg, arm) 100. Limb 100 includes a venous system 102 that returns deoxygenated blood from limb 100 to the heart.

[0238] FIG. 2B shows a cross-section of a portion of a vein 104 of a venous system 102 having normal blood flow. The vein 104 includes a flow path 106 for deoxygenated blood bounded by a wall 118 of the vein 104. The vein 104 may include a valve 110. The valve 110 may open to allow blood to flow toward the heart and close to prevent backflow. A pocket 112 may be located downstream of the valve 110 between the valve 110 and the wall 118 of the vein 104. As shown, some of the blood in the flow path 106 may flow into the pocket 112. A thrombus may begin to form on the wall 118 of the vein 104, on the valve 110, and / or within the pocket 112, as shown in FIG. 2C, until a thrombus 108 forms, as shown in FIG. 2D. The thrombus 108 may fill the flow path 106, which may include extending around the valve 110 and into the pocket 112. The thrombus 108 can interfere with the proper functioning of the valve 110. The thrombus 108 can partially or completely block blood flow through the vein 104. In some cases, an embolus 114 may break off from the thrombus 108, as shown in FIG. 2E. The embolus 114 can travel to other areas of the body, including to the lungs, and can even cause a pulmonary embolism (PE), a potentially fatal condition. Therefore, removing the thrombus can help prevent a patient from becoming fatal.

[0239] FIG. 3A shows a human limb 100 (e.g., leg, arm). The limb 100 includes a venous system 102 having multiple veins 104. As shown in FIG. 3B, a blood clot 108 can form within the vein 104 and block blood flow. The blocked blood flow can prevent blood from exiting the limb 100, as shown by portion 116, and can cause swelling of the limb 100 below the blood clot 108. As described further herein, an embolus 114 can break off from the blood clot 108 and travel to other areas of the body, including to the lungs, causing a pulmonary embolism (PE).

[0240] As the thrombus ages, the properties of the adjacent portion of the vein and the thrombus itself may change as shown in the table shown in FIG.

[0241] For example, in the early stage after formation (e.g., 2 days after thrombus formation), a thrombus may be referred to as an acute thrombus. The vein wall adjacent to an acute thrombus may be thin and have a low collagen content. The primary cells found in the vein wall adjacent to an acute thrombus may be neutrophils. The acute thrombus itself may have no collagen or only a relatively small amount of collagen. The primary cells found in an acute thrombus may be neutrophils. An acute thrombus may easily detach from and / or penetrate the vein wall.

[0242] After some additional time (e.g., 6 days after thrombus formation), the thrombus may be referred to as a subacute / chronic thrombus. The vein wall adjacent to the subacute / chronic thrombus may be thickened and have a higher collagen content compared to the acute thrombus period. The primary cells found in the vein wall adjacent to the subacute / chronic thrombus may be neutrophils and monocytes, with the amount of monocytes significantly increased compared to the acute thrombus period. The subacute / chronic thrombus itself may have an increased collagen content compared to the acute thrombus. The primary cells found in the subacute / chronic thrombus may be neutrophils and monocytes. The subacute / chronic thrombus may be more difficult to detach from the vein wall and / or more difficult to penetrate compared to the acute thrombus. The subacute / chronic thrombus may be lower in weight compared to the acute thrombus.

[0243] After some additional time (e.g., 14 days after thrombus formation), the thrombus may be referred to as a chronic thrombus. The vein wall adjacent to the chronic thrombus may be thickened and have a higher collagen content compared to the subacute / chronic thrombus period. The predominant cells found in the vein wall adjacent to the chronic thrombus may be monocytes. Chronic thrombus may have increased collagen content compared to subacute / chronic thrombus. The predominant cells found in chronic thrombus may be monocytes. Chronic thrombus may be more difficult to detach from the vein wall and / or more difficult to penetrate compared to subacute / chronic thrombus. Chronic thrombus may be lower in weight compared to subacute / chronic thrombus.

[0244] The hardness of a thrombus may increase over time, which may be due to an increase in collagen content. For example, a chronic thrombus may be harder than a subacute / chronic thrombus, which may be harder than an acute thrombus. As a thrombus becomes harder, it may become more difficult to penetrate and remove. Furthermore, as mentioned above, a chronic thrombus may be less likely to detach from the vein wall than a subacute / chronic thrombus, which may be less likely to detach from the vein wall than an acute thrombus.

[0245] As shown in Figure 5A, an acute thrombus may be accompanied by inflammation of the adjacent vein wall as well as stretching of the adjacent vein wall. An acute thrombus may also damage endothelial cells along the vein wall. A patient may experience pain and swelling in the area of ​​the body with the acute thrombus. An acute thrombus may progress over time to a chronic thrombus. A chronic thrombus may be accompanied by venous hypertension, thickening of the vein wall, and matrix changes within the vein wall. A patient may experience, at a minimum, swelling and pigmentation in the area of ​​the body with the chronic thrombus.

[0246] FIG. 6 illustrates another exemplary cross-section of a vein 104 having a thrombus 108. The thrombus 108 is positioned against a wall 118 and a valve 110 of the vein 104. The thrombus 108 is positioned within a pocket 112. As shown, the thrombus 108 may cause hypoxia in the pocket 112 and surrounding tissue. During a thrombus removal procedure, the thrombus 108 is penetrated; however, as described above, the thrombus 108 may harden over time, making penetration more difficult. Additionally, the thrombus 108 may become increasingly difficult to detach from the wall 118 and / or valve 110 over time. Therefore, for at least the reasons described above, a surgeon may need to make multiple passes with a thrombus removal device to remove the thrombus. Each pass may scrape the wall 118 to remove the thrombus. The likelihood of damaging the wall 118 and / or valve 110 of the vein 104 increases with the number of passes. The thermal thrombectomy systems and methods disclosed herein may reduce the number of passes to remove the thrombus (which may include reducing it to a single pass), which may reduce the risk of re-thrombosis, and may include reducing the potential for damage to the wall 118 and / or valve 110. The thermal thrombectomy systems and methods disclosed herein may result in an overall easier and / or shorter procedure, which may reduce the risk of complications and improve efficiency.

[0247] As described herein, the thermal thrombectomy systems and methods disclosed herein may include heating the thrombus. Heating the thrombus may facilitate penetration of the thrombus. Heating the thrombus may facilitate disintegration of the thrombus. Heating the thrombus may facilitate detachment of the thrombus from the vessel wall. Heating the thrombus may soften and / or emulsify (e.g., melt, liquefy) the thrombus (e.g., one or more proteins (e.g., collagen) and / or other thrombus-forming components (e.g., biopolymers). The thrombus may soften and / or emulsify when heated to a temperature within the range of 60-300°C, 60-200°C, 60-120°C (e.g., 80°C), 60-70°C, and / or 60-80°C. Thus, Thus, the heating elements (e.g., wires, loops, lassos, hoops, nozzles, and / or others) described herein may be heated to temperatures between 60-300°C, 60-200°C, 60-120°C (e.g., 80°C), 60-70°C, 60-80°C, or other temperatures. For example, the heating elements may be heated to temperatures between 64-70°C, 66-70°C, 68-70°C, 70-72°C, 72-74°C, 74-76°C, 76-78°C, and other temperatures. The heating element may be heated to 64-66°C and / or 66-68°C. The heating element may be heated to approximately 80°C. The heating element may be heated to any temperature within the aforementioned ranges. The temperature of the heating element may be adjusted and / or controlled based on the temperature at the heating element and / or the interface between the heating element and the thrombus and / or other occlusion. For example, the systems and methods disclosed herein may use one or more temperature sensors (e.g., thermocouples) to sense the temperature at the heating element and / or the interface between the heating element and the thrombus and / or other occlusion, and adjust and / or control the temperature of the heating element based on the sensed temperature. The systems and / or methods described herein may include insulation to protect the patient's anatomy from heat.

[0248] Heating the clot may promote (e.g., soften) the glass transition of the clot, such as the glass transition of one or more proteins (e.g., collagen) and / or other thrombogenic components (e.g., biopolymers). For example, FIG. 7A shows an exemplary graph depicting the stiffness / elastic modulus (MPa) versus temperature (k) of a clot, which may include one or more proteins (e.g., collagen) and / or other thrombogenic components. As shown, at the glass transition temperature (Tg), the clot, which may include one or more thrombogenic components, may reach the glass transition where it may begin to flow more easily in a glassy state (solid to liquid). FIG. 7B shows an exemplary graph depicting the specific volume of a clot, which may include one or more proteins (e.g., collagen) and / or other thrombogenic components, versus temperature. Again, at the glass transition temperature (Tg), the clot, which may include one or more proteins (e.g., collagen) and / or other thrombogenic components, may reach the glass transition. When heated to a glass transition temperature, a thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombogenic components, may change from a first state (e.g., a rigid state) to a second state that is softer than the first state. When heated to a glass transition temperature, a thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombogenic components, may experience a decrease in viscosity.

[0249] The thermal thrombectomy systems and methods described herein may heat a thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming components thereof, to a temperature sufficient to soften and / or emulsify (e.g., melt, liquefy) the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming components, and / or promote a glass transition of the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming components. The thermal thrombectomy systems and methods described herein may heat a thrombus, which may include collagen and / or other thrombus-forming components thereof, to reduce the viscosity of the thrombus, which may include collagen and / or other thrombus-forming components thereof. The temperature for softening a thrombus, which may include one or more proteins and / or other thrombus-forming components, may be the glass transition temperature. The temperature for emulsifying (e.g., melt, liquefy) a thrombus, which may include one or more proteins and / or other thrombus-forming components, may be higher than the transition temperature (e.g., melting temperature).

[0250] FIG. 8 illustrates an exemplary thermal thrombectomy system 122, which may be a device (e.g., a reusable device, a disposable device, a partially disposable device, etc.). The thermal thrombectomy system 122 may include a wire 124, which may be a guidewire. The wire 124 may be at least solid or braided. The wire 124 may include one or more materials. For example, the wire 124 may include a metal such as steel (e.g., stainless steel) and / or a nickel-titanium alloy (e.g., Nitinol). The wire 124 may include a coating, which may include a TEFLON® and / or Parylene coating. The wire 124 may be straight. The wire 124 may include one or more expandable features, such as a coil, a corkscrew, a drill, an auger, a tapered wire drill, a shrink coil, a scrubber, an umbrella, a mesh, a bag, and / or the like.

[0251] The thermal thrombectomy system 122 may include various software and hardware components for implementing aspects of the present disclosure, which may include at least a temperature modulation unit 130, a controller 132, and / or a power source 134, or at least an interface for receiving energy from a power source. The wire 124 may be operably connected to the temperature modulation unit 130. The temperature modulation unit 130 may regulate the temperature of the wire 124 (e.g., a heating element, heater, etc.). For example, the temperature modulation unit 130 may increase the temperature (e.g., heat) of the wire 124. The temperature modulation unit 130 may directly or indirectly heat the wire 124 using one or more energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, induction heating, nuclear, heated liquid, and / or others. For example, the temperature modulation unit 130 may apply a current to the wire 124, increasing the temperature of the wire 124. In some variations, the temperature modulation unit 130 can reduce (e.g., cool) the temperature of the wire 124. The temperature of the wire 124 may be heated to a temperature described herein. The temperature of the wire 124 may be automatically modulated based on monitored conditions in the blood vessel and / or thrombus (e.g., sensed by a temperature sensor). The temperature of the wire 124 may be adjusted to accommodate convective losses. The temperature of the wire 124 may be controlled by a surgeon. A controller 132 may be operatively connected to the temperature modulation unit 130 to perform the temperature control described herein by the temperature modulation unit 130.

[0252] The power source 134 may be a battery, which may include a rechargeable battery and / or a disposable, one-time-use battery. The power source 134 may provide power to the thermal thrombectomy system 122, which may include the controller 132 and / or the temperature modulation unit 130. The power source 134 may provide energy to regulate the temperature (e.g., heat) of the wire 124. In some variations, the thermal thrombectomy system 122 may be operably connected to an external power source.

[0253] The thermal thrombectomy system 122 may also include memory, a communication interface (wired or wireless), a user interface (e.g., buttons, dials, switches, displays, touchpads, touchscreens, knobs, triggers, indicators, gauges, and / or sliders), etc. to implement aspects of the present disclosure. The temperature modulation unit 130, the controller 132, the power supply 134, and / or other components of the thermal thrombectomy system 122 may be housed within a housing 128, which may be a handle.

[0254] The thermal thrombectomy system 122 may include a sheath 126, which may also be referred to as a cover or insulator. The sheath 126 may insulate the wire 124 from the patient's anatomical structure, such as a blood vessel. The sheath 126 may be disposed over a proximal portion of the wire 124, or may include being disposed over the entire wire 124 except for a distal portion. The wire 124 may, in some variations, be deployed from and retracted into the sheath 126. In some variations, the sheath 126 may be an insulating coating disposed over the wire 124.

[0255] In use, the wire 124 may be navigated through the vasculature to the thrombus. In some variations, the wire 124 may be routed to the thrombus through a catheter. The wire 124 may be heated by the temperature modulation unit 130 to soften and / or emulsify the thrombus, which may contain one or more proteins (e.g., collagen) and / or other thrombus-forming elements. The wire 124 may be heated by the temperature modulation unit 130 and then advanced into the thrombus to facilitate penetration, which may be particularly advantageous when penetrating a chronic thrombus. As the wire 124 advances through the thrombus, the heat from the wire 124 may soften and / or emulsify the thrombus, which may contain one or more proteins (e.g., collagen) and / or other thrombus-forming elements. In some variations, the wire 124 may be threaded through the thrombus before heating, which may allow the expandable device to be positioned distal to the thrombus before heating.

[0256] In some variations, the wire 124 may include one or more cutting and / or abrading features (e.g., coils, corkscrews, drills, augers, tapered wire drills, contracting coils, scrubbers, umbrellas, mesh, and / or others). The one or more cutting features may escape the wall of the vessel adjacent to the thrombus to detach the thrombus from the vessel wall. The one or more cutting features may sever and disrupt the thrombus. The one or more cutting features may engage and capture the thrombus, and the surgeon may extract the thrombus by retracting the wire 124 proximally from the patient. The one or more cutting features may be heated to soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements. In some variations, a cutting device and / or an expandable collection device separate from the wire 124 may be advanced along the wire 124, possibly via a sheath or catheter. The cutting device and / or the expandable collection device may or may not be heated. The sheath 126 can protect the blood vessel from the heat of the wire 124 .

[0257] The thermal thrombectomy system 122 may include an expandable collection device (e.g., a bag, an everted mesh, a mesh, a cage, an umbrella, a balloon, a basket, a funnel, etc.) that may be placed distal to the thrombus to prevent the thrombus or its fragments (e.g., emboli) from breaking up and migrating to another area of ​​the body. In some variations, the wire 124 may include an integrally formed expandable device. In some variations, an expandable device separate from the wire 124 may be advanced over the wire 124 using a sheath and / or catheter. The expandable device may include a heating portion in some variations.

[0258] 9A-9D illustrate an exemplary method of using a thermal thrombectomy system 122 to remove a thrombus. As shown in FIG. 9A, the distal end of a wire 124 (e.g., a guidewire) may be navigated through the vasculature to a thrombus within a blood vessel, such as a vein 104. The wire 124 may be heated by a temperature modulation unit 130. The wire 124 may be heated to account for convective losses from blood flow through the flow path 106. In some variations, the wire 124 may include a sensor for detecting heat. The wire 124 may be heated to a temperature sufficient to raise the temperature of the thrombus, which may include one or more proteins (e.g., collagen) of the thrombus and / or other thrombus-forming elements, to soften and / or emulsify them.

[0259] The distal portion of the heating wire 124 may be advanced through the thrombus 108 to soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, such that the distal end of the wire 124 is positioned distal to the thrombus 108. The wire 124 may continue to apply heat to the thrombus once passed, or may cease applying heat. The sheath 126 may insulate portions of the blood vessel not proximate the thrombus from the heating wire 124. In some variations, the wire 124 may be passed through the thrombus 108 before applying heat via the wire 124.

[0260] 9B , an expandable device 136 (e.g., an expandable collection device) may be advanced along the wire 124 and through the thrombus 108 until an expandable end 138 of the expandable device 136, such as a bag (e.g., mesh, abrasive, etc.), an inverted mesh, an umbrella, a balloon, a basket, a funnel (e.g., a mesh funnel), a disk, and / or other device, is located distal to the thrombus 108. The expandable end 138 may be deployed (e.g., expanded) distal to the thrombus 108 to prevent the thrombus 108 and / or portions thereof from migrating distally to another area of ​​the body. The expandable end 138 and / or a distal portion of the expandable device 136 may include a tip 140. In some variations, the tip 140 may be heated to assist the expandable end 138 in passing through the thrombus 108. In some variations, the area around the expandable end 138 that extends to the wall 118 of the vein 104 may be heated, which may help to detach the thrombus 108 from the wall 118. The expandable device 136 may be advanced along the wire 124 using a catheter 137 or sheath. In some variations, portions of the catheter 137 or sheath may be heated, which may include a distal portion.

[0261] As shown in FIG. 9C , the cutting device 142 may be advanced along the wire 124 to the thrombus 108. The cutting device 142 may be advanced along the wire 124 and / or catheter 137 with the catheter 164 to position an auger 166 or other feature (e.g., a coil, drill, corkscrew, tapered wire drill, contraction coil, etc.) adjacent to the thrombus 108 for cutting, penetrating, and / or scraping the thrombus 108. In some variations, the auger 166 or other feature may be advanced while rotating to cut, thread into, and / or disrupt the thrombus 108. The auger 166 may scrape the wall 118 of the vein 104 to ablate the thrombus 108. The auger 166 may be inserted radially from the wall 118 of the vein 104 to ablate the thrombus 108. The auger 166 and / or other portions of the cutting device 142, which may include the catheter 164, may be heated. The cutting device 142 may be retracted through the catheter 144 .

[0262] As shown in FIG. 9D , the catheter 144 may be an aspiration device that includes a channel for an instrument, an aspiration channel 146 for fragments 109 of the thrombus 108, and a return channel 148 for returning filtered blood removed from the flow path 106 by the aspiration channel 146. The catheter 144 may be advanced toward the expandable end 138 of the expandable device 136 to aspirate the fragments 109 of the thrombus 108 into the aspiration channel 146. In some variations, the expandable end 138 of the expandable device 136 may be retracted proximally toward the catheter 144 so that the aspiration channel 146 may aspirate the fragments 109 of the thrombus 108. In some variations, a portion of the catheter 144, such as the distal end, may be heated. The wire 124 or any other described feature may or may not be heated during any of the steps described with reference to FIGS. 9A-9D .

[0263] 10A-10E illustrate an exemplary method of using a thermal thrombectomy system 122 to remove a thrombus. As shown in FIG. 10A, a thrombus 108 can form along the wall 118 and / or valve 110 of a vein 104, obstructing flow. As shown in FIG. 10B, the distal end of a wire 124 can be navigated to pass distally through the thrombus 108. The wire 124 can be heated as described herein, which can aid in the wire 124 penetrating the thrombus 108. The heated wire 124 can soften and / or emulsify the thrombus, which can include one or more proteins (e.g., collagen) and / or other thrombus-forming elements of the thrombus, which can make the thrombus more easily disrupted and / or detached from the wall 118. A sheath 126, which can be a catheter, can protect the vein 104 from damage.

[0264] 10C, the cutting device 143 may be deployed (e.g., extended) from a distal portion of the wire 124, which may include the portion of the wire 124 distal to the thrombus 108. The cutting device 143 may include a lasso (e.g., a loop) and / or any of the other cutting features described herein. In some variations, the cutting device 143 may be a separate component from the wire 124 and may be advanced (e.g., with a catheter or sheath) along the wire 124 to a location distal to the thrombus 108.

[0265] 10D , the expandable end 138 of the expandable device 136 may include any of the expandable features described herein (e.g., umbrella, bag, balloon, etc.) and may be deployed (e.g., expanded) from the distal end of the wire 124, which may include a portion of the wire 124 distal to the thrombus 108. The expandable device 136 may prevent the thrombus 108 and / or its fragments from migrating distally to other areas of the body. In some variations, the expandable device 136 may be a separate component from the wire 124 and may be advanced (e.g., with a catheter or sheath) along the wire 124 to a location distal to the thrombus 108 prior to expansion of the expandable end 138.

[0266] 10E , the wire 124, cutting device 143, and / or expandable device 136 may be retracted proximally together to remove the thrombus 108. The wire 124, cutting device 143, and / or expandable device 136 may be retracted through a funnel 150 (e.g., a mouth) that may be positioned on a distal portion of the catheter (e.g., sheath 126) to guide the thrombus 108, along with the wire 124, cutting device 143, and / or expandable device 136, into the catheter for removal. The funnel 150 may be deployed (e.g., expanded) once the catheter is positioned proximate to the thrombus 108. The wire 124, cutting device 143, and / or expandable device 136 may be retracted proximally to remove the thrombus 108 from the patient. In some variations, the wire 124, cutting device 143, expandable device 136, funnel 150, and / or catheter may be retracted proximally together to remove the thrombus 108.

[0267] FIG. 11 shows an exemplary expandable device 136 (e.g., a collection device, capture device), which may be passive. The expandable device 136 may be advanced through a catheter 162, which may be an outer catheter. The expandable device 136 may include a catheter or sheath 137. The catheter 137 may be advanced along a guidewire through the thrombus to position the expandable end 138 of the expandable device 136 distal to the thrombus. With the expandable end 138 distal to the thrombus, the expandable end 138 may be deployed (e.g., expanded). The expandable end 138 shown in FIG. 11 depicts an inverted mesh, but any of the expandable devices / ends described herein may be used. The expandable device 136 may prevent the thrombus and its fragments from migrating distally to other areas of the body during the procedure. The expandable device 136 may be retracted proximally to urge the thrombus or its fragments proximally, which may include into a catheter, funnel, or the like for removal. A funnel 150, which may be a mesh, may be placed in the distal portion of the catheter 162 to prevent thrombus and its fragments from migrating proximally past the distal opening of the catheter 162 without entering. In some variations, the funnel 150 may be retracted along with the expandable device 136, trapping thrombus and its fragments between the expandable end 138 and the funnel 150 for removal. Any portion of the expandable end 138 may be heated using at least the techniques described herein.

[0268] FIG. 12 shows an exemplary expandable device 136, which may be active. The expandable device 136 may be advanced through a catheter 162, which may be an outer catheter 162. The expandable device 136 may include a catheter or sheath 137. The catheter 137 may be advanced along a guidewire through the thrombus to position the expandable end 138 of the expandable device 136 distal to the thrombus. With the expandable end 138 distal to the thrombus, the expandable end 138 may be deployed (e.g., expanded). The expandable end 138 illustrated in FIG. 12 shows an umbrella, but any of the expandable devices / ends described herein may be used. The expandable device 136 may prevent the thrombus and its fragments from migrating distally to other areas of the body during the procedure. The expandable device 136 may be retracted proximally to urge the thrombus or its fragments proximally, which may include into a catheter, funnel, or the like for removal. A funnel 150 may be placed in the distal portion of catheter 162 to prevent thrombus and its fragments from migrating proximally past the distal opening of catheter 162 without entering. In some variations, funnel 150 can be retracted along with expandable device 136, trapping thrombus and its fragments between expandable end 138 and funnel 150 for removal. Any portion of expandable end 138 may be heated using at least the techniques described herein.

[0269] 13A-13C illustrate an exemplary method of using a thermal thrombectomy system 122 with a wire 124 having a coil 167 (e.g., a helical coil). The distal end of the wire 124 may be navigated to the location of the thrombus 108. In some variations, the wire 124 may be navigated to the location of the thrombus 108 within a catheter 164, which may also be referred to as a sheath, and with the distal end of the catheter 164 in proximity to the thrombus 108, the distal end of the wire 124 may be advanced out of the catheter 164 and in proximity to the thrombus 108. The coil 167 may be self-expanding outside of the catheter 164. As described herein, an energy source may be applied to the wire 124 to heat it. For example, an electric current may be applied to the wire 124 to heat it. Wire 124 may be heated to a temperature that softens and / or emulsifies the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, and the temperature may be any of the other temperatures described herein. Coil 167, or any other coil described herein, may be positioned at or radially inward of the vessel wall.

[0270] 13A , the wire 124, which may be heated, can be advanced distally and rotated such that the coil 167 coils (e.g., threads into) around and / or through the thrombus 108. As the coil 167 advances and rotates, the coil 167 can abrade the wall 118 of the vein 104, detaching the thrombus 108 therefrom. The coil 167 may also be wedged radially away from the wall 118 to avoid abrading the wall 118. The heat of the wire 124 may facilitate penetration of the wire 124 into and / or detachment from the wall 118 of the vein 104 as the thrombus, which may include one or more proteins (e.g., collagen) and / or thrombus-forming elements, is softened and / or emulsified. The heat from the wire 124 may facilitate disruption of the thrombus 108.

[0271] As shown in FIG. 13B , with the coil 167 around and / or through the thrombus 108, the wire 124 may be retracted to fragment the thrombus 108. The wire 124 may be heated to facilitate fragmentation of the thrombus 108. The funnel 150 may be positioned proximal to the thrombus 108, and the proximally migrating thrombus 108 and / or its fragments may be directed through the funnel 150 into the catheter 164 and / or another catheter for removal from the patient. The wire 124, including the coil 167, may be retracted through the catheter 164 for removal. As shown in FIG. 13C , the thrombus 108, including its fragments, may be aspirated from the blood vessel (e.g., a vein or artery) through the catheter 164 and / or another catheter. An expandable device, including at least those described herein, may be positioned distal to the thrombus 108. In some variations, only the inner circumference of the coil 167 is heated and / or the outer circumference of the coil 167 is insulated.

[0272] 14A-14C illustrate an exemplary method of using a thermal thrombectomy system 122 having a wire 124 with a tapered coil 169 (e.g., a helical coil, a wire drill, etc.). The tapered coil 169 may be tapered in a proximal-to-distal direction, with the distal portion having a smaller diameter than the proximal portion. The tapered coil 169 may be positioned proximal to a straight distal portion 170 of the wire 124. In some variations, the tapered coil 169 may be tapered in a distal-to-proximal direction, with the proximal portion having a smaller diameter than the distal portion. In some variations, the tapered coil 169 may be positioned at the distal tip of the wire 124.

[0273] The distal end of the wire 124 may be navigated to the location of the thrombus 108. In some variations, the wire 124 may be navigated to the location of the thrombus 108 within a catheter 164, which may also be referred to as a sheath, and with the distal end of the catheter 164 in proximity to the thrombus 108, the distal end of the wire 124 may be advanced out of the catheter 164 and in proximity to the thrombus 108. The tapered coil 169 may self-expand outside the catheter 164. As described herein, an energy source may be applied to the wire 124 to heat it. For example, an electric current may be applied to the wire 124 to heat it. The wire 124 may be heated to a temperature that softens and / or emulsifies the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, and the temperature may include at least any temperature described herein.

[0274] As shown in FIG. 14A , the wire 124, which may be heated, can be advanced distally so that the straight portion 170 penetrates the thrombus 108. The heat of the wire 124 can facilitate penetration into the thrombus 108. The wire 124 can continue to be advanced and rotated beyond the straight portion 170 so that the tapered coil 169 threads (e.g., spirals) into the thrombus 108 and / or detaches the thrombus 108 from the vessel wall, as shown in FIG. 14B . The path of the tapered coil 169 can cut various planes of the thrombus 108, which may include all planes. A funnel 150 can be positioned proximal to the thrombus 108 to facilitate suction through the catheter 164 and / or the outer catheter 162. The funnel 150 and outer catheter 162 can be positioned over the catheter 164. The funnel 150 can be positioned at the distal end of the outer catheter 162. As shown in FIG. 14C , the coil path (e.g., track) of the tapered coil 169 may create holes (e.g., tunnels, channels, etc.) through the thrombus 108 to facilitate suction. The tapered coil 169 may fragment the thrombus 108. When the tapered coil 169 is retracted proximally, it may fragment and / or detach the thrombus 108 from the wall of the blood vessel. The thrombus 108, or at least a portion thereof, may be captured by the tapered coil 169 such that retraction of the wire 124 retracts the thrombus 108 through the funnel 150 and into the catheter 162 and / or catheter 164, which may or may not include suction. The fragmented thrombus 108 may be extracted via the catheter 164 and / or catheter 162 by retraction of the tapered coil 169 through the catheter 164 and / or by suction through the catheter 164 and / or catheter 162. An expandable device, including at least those described herein, may be positioned distal to the thrombus 108. In some variations, only the inner circumference of the tapered coil 169 is heated and / or the outer circumference of the tapered coil 169 is insulated.

[0275] FIG. 15 illustrates a thermal thrombectomy system 122 in which a catheter 164 carrying a wire 124 and a coil 167 carries the coil 167 distal to the thrombus 108 before the coil 167 is deployed from the catheter 164. The catheter 164 can be navigated to the thrombus 108. The catheter 164 can be advanced to penetrate and pass through the thrombus 108. In some variations, a distal portion of the wire 124, which can be heated, can protrude from the distal end of the catheter 164 to facilitate penetration. In some variations, the distal portion of the catheter 164 can be heated to facilitate penetration through the thrombus 108. With the distal end of the catheter 164 distal to the thrombus 108, the wire 124 can be advanced such that the coil 167 is located distal to the catheter 164 and the thrombus 108. The coil 167 can be self-expanding outside of the catheter 164. Catheter 164 may be retracted proximally and back into outer catheter 162. Coil 167 may be retracted proximally and / or rotated to cut into and / or detach thrombus 108 from the wall of the blood vessel, thus fragmenting thrombus 108. Thrombus 108 may be captured by coil 167 such that thrombus 108 is displaced into catheter 164 and / or catheter 162 as wire 124 is retracted into catheter 164 disposed within catheter 162. Catheter 164 and / or catheter 162 may aspirate thrombus 108. An expandable device, including at least those described herein, may be positioned distal to thrombus 108.

[0276] 16A and 16B show a cutting device 145, which may also be referred to as a scraping device. The cutting device 145 may include a catheter 164, which may also be referred to as a sheath. The cutting device 145 may include a helix 165, which may also be referred to as a coil, a tapered coil, a spatula, a spatula helix, or the like. The helix 165 may taper in a distal-to-proximal direction, with the proximal portion having a smaller diameter than the distal portion. The helix 165 may extend from the distal portion of the catheter 164. The helix 165 may include a flat member (e.g., a flat wire) that forms the helix shape. The width of the flat member in the proximal-to-distal direction may increase as the helix 165 moves away from the catheter 164. The flat member may have a generally rectangular cross-section or may include one with rounded ends. The flat member may have a cross-section whose longest dimension is the proximal-to-distal length. The cutting device 145 may be advanced proximal to the thrombus. The cutting device 145 may be advanced over a guidewire proximal to the thrombus. The cutting device 145 may be advanced distally and / or rotated so that the spiral 165 cuts into the thrombus and / or detaches the thrombus from the vessel wall. The spiral 165 may be heated to facilitate detachment of the thrombus from the vessel wall and / or severing the thrombus. For example, the spiral 165 may include a heating portion 172, which may be heated to soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements. The flat member shape of the spiral 165 can avoid damage to the vessel wall and / or valve as the spiral 165 detaches the thrombus from the vessel wall. In some variations, the spiral 165 may fragment the thrombus and / or capture (e.g., portions of) the thrombus.

[0277] 17 shows a cutting device 176, which may also be referred to as a scrubber device and / or a variable scrubber device. The cutting device 176 may include a catheter 178, which may also be referred to as a sheath. The cutting device 176 may include a plurality of scrubbing members 185, which may also be referred to as cutting members, scraping members, etc. The scrubbing members 185 may be distributed along the longitudinal length of the cutting device 176, which may include a portion of the longitudinal length (e.g., a distal portion). The scrubbing members 185 may be distributed circumferentially around the circumference of the catheter 178. The scrubbing members 185 may extend radially outward to different radial distances. For example, the scrubbing members 185 may include a first scrubber 180 that may extend radially a first radial distance, a second scrubber 182 that may extend radially a second radial distance greater than the first radial distance, and / or a third scrubber 184 that extends radially a third radial distance greater than the second radial distance. In some variations, the scrubbing members 185 may extend from the interior to the exterior of the catheter 178. In some variations, the scrubbing members 185 may not extend from the interior to the exterior of the catheter 178. In some variations, the scrubbing members 185 may be fixedly attached to and extend from the exterior surface of the catheter 178. In some variations, the scrubbing members 185 may be wires. The wires may be curved (e.g., looped) in the proximal direction. The radius of curvature of the third scrubber 184 may be larger than the radius of curvature of the second scrubber 182, which may be larger than the radius of curvature of the first scrubber 180. In some variations, the cutting device 176 may be advanced along the wire 124 for positioning. Portions of the cutting device 176 may be heated, which may include at least the scrubbing members 185, the third scrubber 184, the second scrubber 182, the first scrubber 180, and / or the catheter 178. The cutting device 176 may be advanced and / or retracted through the thrombus. The scrubbing members 185 may cut the thrombus and / or detach it from the vessel wall. The scrubbing members 185 may fragment the thrombus.

[0278] FIG. 18 illustrates a cutting device 186. The cutting device 186 may include cutting and / or suction features. The cutting device 186 may include a catheter 188, which may be sheathed to facilitate advancement along the wire 124. The cutting device 186 may be deployed distally from inside the catheter 196, which may be stationary. The cutting device 186 may aspirate the thrombus. The cutting device 186 may include an expandable feature such as a helix 192 (e.g., a coil). The helix 192 may extend radially outward. The helix 192 may self-expand when the coil 192 is positioned outside the catheter 196. The helix 192 may include a plurality of struts 194 that support the helix 192 in an expanded configuration. The struts 194 may extend from the outside of the catheter 188. The helix 192 may spiral around the exterior of the catheter 188. The helix 192 can spiral along the distal portion of the catheter 188. The cutting device 186 can include suction openings 190. The suction openings 190 can be positioned through the catheter 188 to aspirate the thrombus. The suction openings 190 can be distributed along the distal portion of the catheter 188. The suction openings 190 can be distributed around the helix 192. Portions of the cutting device 186, which can include at least the catheter 188, the helix 192, the struts 194, the periphery of the suction openings 190, and / or other portions, can be heated. The cutting device 186 can be advanced distally (or retracted proximally) and rotated to cut the thrombus using the helix 192 and / or detach the thrombus from the vessel wall. The suction openings 190 can aspirate fragments of the thrombus. The catheter 196 can aspirate fragments of the thrombus. The spiral 192 may capture the thrombus, or at least a portion thereof, so that upon retraction, the thrombus may be removed by the catheter 196 .

[0279] FIG. 19A shows an aspiration device 198, which may also be referred to as a catheter and / or aspiration catheter, that can aspirate thrombus from a blood vessel. The aspiration device 198 may include multiple channels. The aspiration device 198 may include an instrumentation channel 204. A guidewire, an expandable device, a cutting device, a catheter, and / or other instrument may be routed (e.g., advanced, retracted, etc.) through the instrumentation channel 204. The aspiration device 198 may include an aspiration channel 200 (e.g., one, two, three, or more aspiration channels) for aspirating thrombus fragments. The aspiration device 198 may include a return channel 202 (e.g., one, two, three, or more return channels) for returning blood received and filtered through the aspiration channel 200 back into the blood vessel. The total cross-sectional flow area of ​​the aspiration channels 200 may be greater than the total cross-sectional flow area of ​​the return channels 202. Ribs may separate the various channels of the aspiration device 198. The instrumentation channel 204 may be at the center of the suction device 198. The intake channel 200 and / or the return channel 202 may be distributed around the instrumentation channel 204.

[0280] 19B shows an aspiration device 199, which may also be referred to as a catheter and / or aspiration catheter, that can aspirate a blood clot from a blood vessel. The aspiration device 199 may include an instrumentation channel 204, an aspiration channel 200, and / or a return channel 202. Each of the instrumentation channel 204, the aspiration channel 200, and / or the return channel 202 may be offset from the center of the aspiration device 199. The instrumentation channel 204, the aspiration channel 200, and / or the return channel 202 may have a circular perimeter. The aspiration channel 200 and the instrumentation channel 204 may be the same size. The aspiration channel 200 may have a larger cross-sectional size than the return channel 202.

[0281] 20 shows a cross section of a suction device 197 capable of aspirating thrombus from a blood vessel. The suction device 197 may include a return channel 202 and an inlet channel 200. The inlet channel 200 may be centered along the longitudinal axis of the suction device 197. The suction device 197 may be operatively connected to a pump 206 that aspirates the thrombus and blood fragments through the inlet channel 200. The inlet channel 200 may pass the thrombus and blood through a filter 208, which filters the thrombus from the blood. The pump 206 may return the filtered blood into the blood vessel via the return channel 202.

[0282] FIG. 21A illustrates a thermal thrombectomy system 123, which may include any of the features of the thermal thrombectomy system 122 described herein. The thermal thrombectomy system 123 can be used to perform thrombectomy. The thermal thrombectomy system 123 can include a power source 134, which may be referred to as an energy source. The power source 134 may include at least a battery (e.g., disposable, rechargeable, etc.), a wired power source, and / or the like. The power source 134 may be external. The power source 134 may deliver 120V AC or another voltage. The thermal thrombectomy system 123 may include a power conditioning unit 210, which may be a dimmer to adjust the voltage provided by the power source 134. The power source 134 and / or the power conditioning unit 210 may be operably connected to a current delivery unit 212, which may be a plastic welder. The current supply unit 212 allows an operator to select the current supplied to the wires 214 of the thermal thrombectomy system 123. For example, the current delivery unit 212 may include a trigger, button, switch, knob, and / or other mechanism that an operator may manipulate (e.g., depress) to deliver and stop delivery of current to the wires 214. The current supply unit 212 and the power conditioning unit 210 may be a single unit. In some variations, the current delivery unit 212, the power conditioning unit 210, and / or the power source 134 or power interface may be combined into a single unit.

[0283] The wire 214 may be a copper wire and may be operably connected to a wire 216, such as a nitinol wire, that cuts and / or ablates the thrombus. An electrical current may be delivered to the wire 216 to increase the temperature (e.g., heat) of the wire 216. The wire 216 may be disposed inside a sheath 220, which may also be referred to as a sleeve, catheter, and / or tube, and the sheath may insulate the blood vessel from the heat of the wire 216. The wire 214 may extend into the sheath 220 and be operably connected to the wire 216. An end 218 (e.g., a looped end) of the wire 216 may extend from the distal end of the sheath 220. The wire 216 may be heated such that the exposed, heated looped end 218 can be used to penetrate the thrombus 108 while the portion of the wire 216 disposed within the sheath 220 is insulated from the wall 118 of the vein 104 or artery.

[0284] As shown in FIG. 21B , the wire 216 may be advanced distally of the sheath 220 to deploy (e.g., expand) the coil 217. The coil 217 may self-expand upon exiting the sheath 220. The coil 217 may include a first coil 222 and a second coil 224 connected to one another. The first coil 222 and the second coil 224 may be overlapping each other. The first coil 222 and the second coil 224 may be coaxially arranged. The coils of the first coil 222 and the second coil 224 may be arranged such that the coils of the first coil 222 are disposed between the coils of the second coil 224. The coils of the second coil 224 may be positioned between the coils of the first coil 222. The coils of the first coil 222 may be equidistantly spaced between the coils of the second coil 224. The coils of the second coil 224 may be equidistantly spaced between the coils of the second coil 224. The coils of the first coil 222 and the second coil 224 may be spiraled around the longitudinal axis of the coil 217, with the coils of the first coil 222 disposed between (e.g., equidistant from) adjacent coils of the second coil 224. In some variations, the first coil 222 and the second coil 224 do not contact until they join at the looped end 218. The proximal-distal gap between the coils of the first coil 222 and the second coil 224 may be equal. The proximal end of the first coil 222 may be connected to one end of the wire 214, and the proximal end of the second coil 224 may be connected to the other end of the wire 214. The distal ends of the first coil 222 and the second coil 224 may be joined to one another at the looped end 218. The looped end 218 may extend distally. The looped end 218 may be positioned on the longitudinal axis of the coil 217.

[0285] As shown in FIG. 21C , the wire 216 may be advanced distally of the sheath 220 to deploy (e.g., expand) the coil 217. The coil 217 may self-expand upon exiting the sheath 220. The coil 217 may include a first coil 222 and a second coil 224. The first coil 222 and the second coil 224 may be coaxially arranged. The coils of the first coil 222 and the second coil 224 may be arranged such that the coils of the first coil 222 are disposed between the coils of the second coil 224. The coils of the second coil 224 may be positioned between the coils of the first coil 222. The coils of the first coil 222 may be parallel to the coils of the second coil 224. The coils of the first coil 222 may be adjacent to the coils of the second coil 224. A coil of the first coil 222 may be closer in the proximal-distal direction to a first adjacent coil of the second coil 224 compared to a second adjacent coil of the second coil 224. The first coil 222 and the second coil 224, in some variations, do not contact until they meet at a bent end 218. The proximal end of the first coil 222 may be connected to one of the wires 214, and the proximal end of the second coil 224 may be connected to the other of the wires 214. The distal ends of the first coil 222 and the second coil 224 may be joined to one another at an end 218 (e.g., a looped end). The looped end 218 may extend in a helical direction of the adjacent portions of the first coil 222 and the second coil 224.

[0286] 22A and 22B illustrate a method of performing thrombectomy using a thermal thrombectomy system 123 having a wire 216 and a sheath 220 described with reference to FIGS. 21A-21C. As shown, the sheath 220 may be routed to the thrombus 108. The wire 216 may be disposed within the sheath 220. As shown in FIG. 22A, the sheath 220 and / or the wire 216 may be delivered adjacent to the thrombus 108 by a catheter 228 and / or a catheter 230. For example, the catheter 230 may be navigated through the vasculature to adjacent (e.g., proximally adjacent) the thrombus 108. The catheter 228 may be advanced through the catheter 230 to adjacent (e.g., proximally adjacent) the thrombus 108. The sheath 220, with the wire 216 disposed therein, may be advanced distally through the catheter 228 to advance the catheter 228 and / or the catheter 230. The looped end 218 of the wire 216 may be positioned distally outside the sheath 220. The wire 216 may be heated. The sheath 220 and the wire 216 therein may be advanced distally together such that the sheath 220 and wire 216 penetrate the thrombus 108. The exposed and heated looped end 218 may facilitate penetration of the thrombus 108. The heated looped end 218 may soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements. The sheath 220 may insulate the blood vessel, the catheter 228, and / or the catheter 230 from the heat of the wire 216.

[0287] As shown in FIG. 22B , the sheath 220 may be retracted proximally to deploy (e.g., unsheath, uncover, expand, etc.) the coil 217 of the wire 216. In some variations, the wire 216 may be advanced such that the coil 217 is positioned distally outside the sheath 220 and deployed (e.g., unsheathed, uncovered, expanded, etc.). The coil 217 may unsheath within the thrombus 108. The coil 217 may self-expand outside the sheath 220. The coil 217 may expand to fragment the thrombus 108. The heat of the coil 217 may soften and / or emulsify the thrombus 108. In some variations, the coil 217 may be deployed and placed within the thrombus 108 to soften and / or emulsify the thrombus 108, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements. Wire 216 may be retracted proximally to pull thrombus 108 into catheter 228 to fragment, detach, and / or remove thrombus 108 from wall 118 of vein 104. In some variations, wire 216 may be rotated to fragment and / or detach thrombus 108 from wall 118 of vein 104. In some variations, catheter 228 and / or catheter 230 may aspirate thrombus 108.

[0288] 23 shows an exemplary sheath 220 and wire 216 that can be used with the thermal thrombectomy systems described herein. The wire 216 may include a coil 236. The coil 236 may be a helical coil. A proximal end of the coil 236 may be operably connected (e.g., by a wire) to an energy source (e.g., an electrical energy source). The wire 216 may include a straight portion 234. The straight portion 234 may extend the length of the coil 236. The straight portion 234 may extend through the coil 236. The straight portion 234 may extend through the coil 236 within an inner circumference of the coil 236. A proximal end of the straight portion 234 may be operably connected (e.g., by a wire) to an energy source (e.g., an electrical energy source). The coil 236 and the straight portion 234 may be joined together at a looped end 218. As described herein, the looped end 218 may extend distally from the sheath 220 and / or catheter to facilitate penetration into the thrombus. The looped end 218 may extend longitudinally of the straight portion 234 and / or the coil 236. Energy, such as electrical energy, may be applied to the wire 216 to heat the wire 216 and soften and / or emulsify the thrombus, which may contain one or more proteins (e.g., collagen) and / or other thrombus-forming elements, thereby facilitating penetration of the thrombus, detachment (e.g., abrasion) of the thrombus from the vessel wall, and / or fragmentation of the thrombus. The sheath 220 may insulate the patient's anatomy from the heat of the wire 216. The wire 216 may be disposed (e.g., retracted) within the sheath 220, and the coil 236 may automatically deploy (e.g., expand) when the wire 216 is advanced distally to move the coil 236 out of the sheath 220. The wire 216 may be disposed within the catheter, and the coil 236 may automatically deploy (e.g., expand) when the wire 216 is advanced distally, moving the coil 236 out of the catheter. The coil 236 may be self-expanding outside the sheath 220.

[0289] In use, the coil 236 may be deployed before penetrating the thrombus. The coil 236 may be advanced distally and / or rotated to thread into the thrombus. In some variations, the sheath 220 and wire 216 may penetrate the thrombus before the coil 236 is deployed. With the sheath 220 and wire 216 within the thrombus, the sheath 220 may be retracted to deploy the coil 236 within the thrombus. In some variations, the distal end of the sheath 220, with the wire 216 disposed within the sheath 220, may be advanced distally of the thrombus. The wire 216 may be advanced distally relative to the thrombus, and / or the sheath 220 may be retracted relative to the wire 216, moving the coil 236 out of the sheath 220 and deploying it. Once the coil 236 is deployed, the wire 216 may be retracted proximally and / or rotated into the thrombus.

[0290] Different portions of wire 216 may be heated. For example, in some variations, straight portion 234, looped end 218, and / or coil 236 may be heated. In some variations, straight portion 234, looped end 218, and / or coil 236 may be insulated (e.g., including an insulating material, insulating coating, insulating cover, etc.). In some variations, the inner circumference of coil 236 may be heated and the outer circumference of coil 236 may be insulated.

[0291] 24 shows an exemplary sheath 220 and wire 216 that can be used with the thermal thrombectomy system described herein. The wire 216 may form a lasso 278, which may also be referred to as a hoop or loop. The lasso 278 may be retracted into and / or deployed from the sheath 220, which may be a catheter. When retracted, the wire 216 may be fully disposed within the sheath 220, or the looped end may extend beyond the distal end of the sheath 220, thus facilitating penetration of the thrombus even when the wire 216 is sheathed. One side of the lasso 278 may be operably connected (e.g., connected by a first wire) to an energy source (e.g., an electrical energy source), and the other side of the lasso 278 may be operably connected (e.g., connected by a second wire) to the energy source. Energy, such as electrical energy, may be applied to wire 216 to heat wire 216 and soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, thereby facilitating penetration of the thrombus, detachment (e.g., abrasion) of the thrombus from the vessel wall, and / or fragmentation of the thrombus. Wire 216 may be advanced distally from sheath 220, and / or sheath 220 may be retracted proximally relative to wire 216, deploying lasso 278. Wire 216 may be advanced distally relative to sheath 220 at various distances, and / or sheath 220 may be retracted proximally relative to sheath 220, to form lassos of various sizes (e.g., lassos of different diameters). For example, when operating in a larger diameter vessel, wire 216 may be advanced further distally relative to sheath 220 to form lasso 278 having a larger diameter compared to when operating in a smaller diameter vessel. Lasso 278 may self-expand outside of sheath 220.

[0292] In use, the lasso 278 may be deployed before penetrating the thrombus. The lasso 278 may be advanced distally and / or rotated into the thrombus. In some variations, the sheath 220 and wire 216 may penetrate the thrombus before the lasso 278 is deployed. With the sheath 220 and wire 216 within the thrombus, the sheath 220 may be retracted to deploy the lasso 278 within the thrombus. In some variations, the distal end of the sheath 220, with the wire 216 disposed within the sheath 220, may be advanced distally of the thrombus. The wire 216 may be advanced distally relative to the thrombus, and / or the sheath 220 may be retracted relative to the wire 216 to move the coil 236 out of the lasso 278 and deploy it. Once the lasso 278 is deployed, the wire 216 may be retracted proximally and / or rotated into the thrombus, thereby capturing the thrombus for extraction, fragmenting the thrombus, and / or detaching the thrombus from the vessel wall.

[0293] FIG. 25 illustrates an exemplary wire 216 that can be used with the thermal thrombectomy system described herein. The wire 216 may be retracted into a sheath and / or extended distally from a sheath as described herein. The wire 216 may include a coil 236. The coil 236 may be a helical coil. The coil 236 may be tapered in a proximal-to-distal direction or a distal-to-proximal direction. The coil 236 may taper from an intermediate portion to a proximal portion such that the intermediate portion has a larger diameter than the proximal portion. The diameter of the coil 236 may be the same from the intermediate portion to the distal portion. The proximal portion of the coil 236 may have a smaller diameter than the distal portion of the coil 236. The proximal end of the coil 236 may be operably connected (e.g., by a wire) to an energy source (e.g., an electrical energy source).

[0294] The wire 216 may include a straight portion 234. The straight portion 234 may extend the length of the coil 236. The straight portion 234 may extend through the coil 236, which may include extending coaxially along the longitudinal axis of the coil 236. The straight portion 234 may extend through the coil 236 within the inner circumference of the coil 236. A proximal end of the straight portion 234 may be operably connected (e.g., by a wire) to an energy source (e.g., an electrical energy source). The coil 236 and the straight portion 234 may be joined together distally (e.g., the distal ends of the coil 236 and the straight portion 234 may be joined together). For example, a transverse portion 242 (e.g., a vertical portion) may connect the distal end of the straight portion 234 to the distal end of the coil 236. Energy, such as electrical energy, may be applied to the wire 216 to heat the wire 216 and soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, thereby facilitating penetration of the thrombus, detachment (e.g., abrasion) of the thrombus from the vessel wall, and / or fragmentation of the thrombus. The sheath 220 may insulate the patient's anatomy from the heat of the unsheathed wire 216. The wire 216 may be disposed (e.g., retracted) within the sheath 220, and the coil 236 may automatically deploy (e.g., expand) when the wire 216 is advanced distally to move the coil 236 out of the sheath 220. The wire 216 may be disposed within a catheter, and the coil 236 may automatically deploy (e.g., expand) when the wire 216 is advanced distally to move the coil 236 out of the catheter. The coil 236 may be self-expanding outside the sheath 220. Figure 26 shows a variation of the wire 216 and sheath 220 described with reference to Figure 25, in which the straight portion 234 may be insulated (e.g., coated with an insulating material, sheathed with an insulating cover, etc.).

[0295] In use, the coil 236 may be deployed before penetrating the thrombus. The coil 236 may be advanced distally and / or rotated to thread into the thrombus. In some variations, the sheath 220 and wire 216 may penetrate the thrombus before the coil 236 is deployed. With the sheath 220 and wire 216 within the thrombus, the sheath 220 may be retracted to deploy the coil 236 within the thrombus. In some variations, the distal end of the sheath 220, with the wire 216 disposed within the sheath 220, may be advanced distally of the thrombus. The wire 216 may be advanced distally relative to the sheath 220 and / or the sheath 220 may be retracted relative to the wire 216 to move the coil 236 out of the sheath 220 and deploy it. Once the coil 236 is deployed, the wire 216 may be retracted proximally and / or rotated into the thrombus, thereby capturing the thrombus for extraction, fragmenting the thrombus, and / or detaching the thrombus from the vessel wall.

[0296] Different portions of wire 216 may be heated. For example, in some variations, straight portion 234, looped end 218, and / or coil 236 may be heated. In some variations, straight portion 234, looped end 218, and / or coil 236 may be insulated (e.g., including an insulating material, insulating coating, insulating cover, etc.). In some variations, the inner circumference of coil 236 may be heated and the outer circumference of coil 236 may be insulated.

[0297] 27A and 27B show the arrangement of a wire 216 that can be used with the thermal thrombectomy systems described herein. The wire 216 may include an outer coil 270 and / or an inner coil 272. The inner coil 272 can be disposed inside the outer coil 270 (e.g., within the inner circumference of the outer coil 270). The inner coil 272 and the outer coil 270 can be parallel to each other. The proximal end of the outer coil 270 can be operably connected (e.g., by a wire) to an energy source (e.g., an electrical energy source). The proximal end of the inner coil 272 can be operably connected (e.g., by another wire) to an energy source (e.g., an electrical energy source). The distal ends of the outer coil 270 and the inner coil 272 can be joined to each other at a looped end 218. The looped end 218 can extend toward the distal ends of the outer coil 270 and the inner coil 272. The looped end 218 may extend distally along a central axis of the outer coil 270 and / or the inner coil 272. The outer coil 270 and the inner coil 272 may be deployed from and / or retracted into a sheath as described herein. Energy, such as electrical energy, may be applied to the wire 216 to heat the wire 216 and soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, thereby facilitating penetration of the thrombus, detachment (e.g., abrasion) of the thrombus from the vessel wall, and / or fragmentation of the thrombus.

[0298] In use, the outer coil 270 and the inner coil 272 may be deployed before penetrating the thrombus. The outer coil 270 and the inner coil 272 may be advanced distally and / or rotated to thread into the thrombus. In some variations, the sheath 220 and wire 216 may penetrate the thrombus before the outer coil 270 and the inner coil 272 are deployed. With the sheath 220 and wire 216 within the thrombus, the sheath 220 may be retracted to deploy the outer coil 270 and the inner coil 272 within the thrombus. In some variations, the distal end of the sheath 220, with the wire 216 disposed within the sheath 220, may be advanced distally of the thrombus. The wire 216 may be advanced distally relative to the sheath 220 and / or the sheath 220 may be retracted relative to the wire 216 to move the outer coil 270 and the inner coil 272 out of the sheath 220 and deploy it. Once the outer coil 270 and inner coil 272 are deployed, the wire 216 may be retracted proximally and / or rotated into the thrombus, thereby capturing the thrombus for extraction, fragmenting the thrombus, and / or detaching the thrombus from the vessel wall.

[0299] Different portions of wire 216 may be heated. For example, in some variations, outer coil 270 and / or inner coil 272 may be heated. In some variations, outer coil 270 and / or inner coil 272 may be insulated (e.g., comprising an insulating material, insulating coating, insulating cover, etc.). For example, as shown in FIG. 27B, inner coil 272 may be heated, and outer coil 270 may be unheated and / or insulated to protect the walls of the blood vessel.

[0300] 28 shows a cutting device 280 that can be used with the thermal thrombectomy systems described herein. The cutting device 280 may include a catheter 276 that can be routed to the thrombus and advanced along a guidewire. The catheter 276 may include a plurality of flutes (e.g., vanes), which may include a first flute 281 and / or a second flute 282. The first flute 281 and / or the second flute 282 may be spiraled along at least a portion (e.g., a distal portion) of the catheter 276. The wire 216 may be disposed along an edge of the first flute 281 and / or the second flute 282. An end of the wire 216 may be connected to an energy source (e.g., an electrical energy source). Energy, such as electrical energy, may be applied to wire 216 to heat wire 216 and soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, thereby facilitating penetration of the thrombus, detachment (e.g., scraping) of the thrombus from the vessel wall, and / or fragmentation of the thrombus. In some variations, cutting device 280 may be disposed inside another catheter or sheath that may collapse first groove 281 and / or second groove 282. First groove 281 and / or second groove 282 may self-expand once moved outside the catheter.

[0301] In use, first groove 281 and second groove 282 may be deployed prior to penetrating the thrombus. First groove 281 and second groove 282 may be advanced distally and / or rotated to thread into the thrombus. In some variations, first groove 281 and second groove 282 may be deployed within the thrombus. In some variations, first groove 281 and second groove 282 may be deployed distally of the thrombus and then retracted into the thrombus, which may include rotation.

[0302] Different portions of cutting device 280 may be heated. For example, in some variations, portions of wire 216, first groove 281, second groove 282, and / or catheter 276 may be heated. In some variations, portions of wire 216, first groove 281, second groove 282, and / or catheter 276 may be insulated (e.g., including with an insulating material, an insulating coating, an insulating cover, etc.).

[0303] 29A-29D illustrate a thermal thrombectomy system 246. The thermal thrombectomy system 246 may include a variable lasso 248, which may also be referred to as a variable loop and / or variable hoop. As shown in FIG. 29A, the variable lasso 248 may be formed from a wire 249, which may be made from a variety of materials, including nitinol. An inner portion 256 of the wire 249, which may have a coil shape, may be disposed inside a catheter 258 (e.g., a sheath). The inner portion 256 of the wire 249 may be advanced out of the catheter 258 through a port 250 (e.g., an opening, a hole, etc.) to increase the size (e.g., diameter) of the variable lasso 248. The inner portion 256 may be retracted into the catheter 258 by the port 250 to decrease the size (e.g., diameter) of the variable lasso 248. The port 250 may be disposed on the distal surface of the catheter 258. The end of the adjustable lasso 248 opposite the port 250 may be secured to a mount 252. The mount 252 may be disposed on the catheter 258 (e.g., on the distal surface of the catheter 258). The distal surface of the catheter 258 may be flat. Energy, such as electrical energy, may be applied to the adjustable lasso 248 to heat the adjustable lasso 248 and soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, thereby facilitating penetration of the thrombus, detachment (e.g., scraping) of the thrombus from the vessel wall, and / or fragmentation of the thrombus. For example, the port 250 and / or the mount 252 may include electrical contacts that may be connected to a power source 254, which may be variable, to apply energy (e.g., electrical energy) to the adjustable lasso 248.

[0304] 29B, the proximal end of inner portion 256 of wire 249 may be connected to cable 260. Cable 260 may be rotated in a first direction to advance inner portion 256 out of port 250, increasing the diameter of variable lasso 248. Cable 260 may be rotated in a second direction opposite the first direction to retract lasso 249 through port 250 and into catheter 258, decreasing the diameter of variable lasso 248.

[0305] 29C, the electrical contacts of the port 250 and / or mount 252 may be electrically connected to a power source 254 by wires 214. The distal end of the catheter 258 may include a stiff tip 262.

[0306] As shown in Figure 29D, the variable lasso 248 may be expanded to a diameter D1 for larger vessels, and as shown in Figure 29E, the diameter of the variable lasso 248 may be reduced to a diameter D2, which is less than D1, for smaller vessels. The diameter of the variable lasso 248 may be set so that the variable lasso 248 is adjacent to the vessel wall to detach the thrombus therefrom.

[0307] In use, the distal end of the thermal thrombectomy system 246 may be positioned proximate to the thrombus. The diameter of the adjustable lasso 248 may be set based on the diameter of the blood vessel. Electrical energy may be applied to the adjustable lasso 248 to heat the adjustable lasso 248. The adjustable lasso 248 may be advanced to soften and / or emulsify the thrombus, which may include one or more proteins (e.g., collagen) and / or other thrombus-forming elements, detaching the thrombus from the vessel wall and / or fragmenting the thrombus.

[0308] The thermal thrombectomy systems and methods disclosed herein may use a vibrating sharp tip and / or vibration. The thermal thrombectomy systems and methods disclosed herein may use a grounding / suction action. The thermal thrombectomy systems and methods disclosed herein may use wires of uniform or variable diameter. The thermal thrombectomy systems and methods disclosed herein may include coils of uniform or variable diameter. The thermal thrombectomy systems and methods disclosed herein may liquefy thrombus without cauterizing the blood or vasculature. The thermal thrombectomy systems and methods disclosed herein may enable minimally invasive use of suction tools. The thermal thrombectomy systems and methods disclosed herein may include an off-axis cutting element (away from the vessel wall) to prevent endoluminal resection or cutting. The thermal thrombectomy systems and methods disclosed herein may include a coil that scrapes against or is inserted radially from the vessel wall. The thermal thrombectomy systems and methods disclosed herein may be used to cut unwanted tissue in a controlled manner. The thermal thrombectomy systems and methods disclosed herein may be used to cut false lumens. The thermal thrombectomy systems and methods disclosed herein may include coils with lead-in circular, closed loop, or elliptical coils. The thermal thrombectomy systems and methods disclosed herein may be placed around the entire periphery of the thrombus and / or inside the vessel wall bordering the thrombus. The disclosed thermal thrombectomy systems and methods may use ultrasonic cutters / jackhammers. The thermal thrombectomy systems and methods disclosed herein may include a water jet returning toward the cannula and / or pressurized saline. The thermal thrombectomy systems and methods disclosed herein may include a coil diameter of 5 to 16 millimeters. The thermal thrombectomy systems and methods disclosed herein may include a coil length of several millimeters between the endothelial cell 120 and the suction opening 190. The thermal thrombectomy systems and methods disclosed herein may include a wire diameter of 0.25 millimeters.

[0309] 30A-30F show cross-sectional views of a vein. As noted elsewhere herein, although the systems and methods described herein are described with respect to veins and thrombi, the systems and methods described herein can be used to remove other blockages in both veins and / or arteries.

[0310] 30A shows a cross-sectional view of a vein 104. The vein 104 may include a flow path 106 for blood bounded by a wall 118. The vein 104 may include a valve 110 that facilitates the movement of blood within the vein 104. The valve 110 may extend radially inward from the wall 118. The valve 110 may extend radially inward at an angle relative to a central longitudinal axis of the vein 104. The vein 104 may include a pocket 112 located just distal to the valve 110.

[0311] Thrombi can form in a variety of locations. The thrombi can impair (e.g., prevent migration of) the valve 110 and / or impede (e.g., partially block, completely block) the flow of blood along the flow path 106 through the vein 104. FIG. 30B shows a thrombus 108 forming on one side of the valve 110. FIG. 30C shows a thrombus 108 forming in a pocket 112 behind one side of the valve 110. FIG. 30D shows the formation of a thrombus 108 located both distally and proximally of the valve 110. FIG. 30E shows a thrombus 108 forming immediately downstream of the valve 110, which may include filling the pocket 112 immediately distal to the valve 110. FIG. 30F shows a thrombus located both distally and proximally to the valve 110 and in the pocket 112 immediately downstream of the valve 110.

[0312] As described herein, a thrombus can change from acute to chronic over time. Figure 30G shows an acute thrombus 108 changing to chronic. The thrombus 108 includes several chronic portions 109 (e.g., portions with increased collagen content and / or harder portions). The chronic portions 109 are located on the wall 118 as shown.

[0313] The systems and methods described herein can be used at least to remove the thrombus illustrated in Figures 30B-30G. The systems and methods can use heat to penetrate the thrombus to traverse it and / or to detach it from the wall of the vessel. The thrombus can be captured and retracted proximally for removal. The thrombus can be aspirated. In some variations, the mouth of the suction device that aspirates the thrombus can be heated.

[0314] 31A-31C illustrate a system 301 (e.g., a thermal thrombectomy system, a thrombus removal system) having a heating element 304 (e.g., a heating element, a heating wire, a heating guidewire, a heating tip, a heating end) for penetrating and traversing a thrombus 108. As shown in FIG. 31A, the system 301 can include a catheter 300 (e.g., an outer catheter). The outer catheter 300 can be routed through the vein 104 and positioned proximal to the thrombus 108. The heating element 304 can be deployed from within the outer catheter 300 and advanced distally through the thrombus 108. As described herein, the heating element 304 can be heated to at least the temperatures described herein. The heating element 304 can be heated directly or indirectly using one or more energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, ultrasound, heated fluid, nuclei, and / or others. The heat from the heating element 304 can facilitate penetration of the thrombus 108. The heat from the heating element 304 can emulsify the thrombus 108, which can include emulsifying the center (e.g., core) of the thrombus 108. The heating element 304 can be disposed inside a catheter 302 (e.g., an inner catheter). The inner catheter 302 can be disposed inside the outer catheter 300. The inner catheter 302 can be advanced distally with the heating element 304 to traverse the thrombus 108. For example, the distal end of the inner catheter 302 can be advanced distally of the thrombus 108 with the distal end of the heating element 304, as shown in FIG. 31B. With the distal end of the inner catheter 302 distal to the thrombus 108, the heating element 304 can be retracted through the inner catheter 302, leaving the inner catheter 302 in place, as shown in FIG. 31C.

[0315] 31D-31F illustrate deployment of a capture device 306 (e.g., an expandable device) of the system 301. As shown in FIG. 31D, the capture device 306 can be advanced distally from the inner catheter 302 to a position distal to the thrombus 108. The capture device 306 can include a distal end 308. The distal end 308 can be rigid. In some variations, the distal end 308 can include a heating element that can replace the heating element 304 to facilitate penetration of the thrombus 108. The capture device 306 can be advanced distally from the inner catheter 302, as shown in FIG. 31E, to release a bag 310 (e.g., a cage, net, mesh, basket). The bag 310 can include a loop 312 (e.g., a hoop, lasso). The loop 312 can be positioned proximal to the bag 310. When outside the inner catheter 302, the loop 312 and / or bag 310 can be biased radially outward such that the loop 312 and / or bag 310 expands (e.g., unfolds) distal to the thrombus 108, as shown in FIG. 31F. The expansion loop 312 and / or bag 310 can contact the wall 118 in some variations. The expansion loop 312 and / or bag 310 can be positioned proximate to the wall 118 in some variations. The loop 312 can be positioned at an opening in the bag 310.

[0316] 31G-31I illustrate retraction of the capture device 306 to capture the thrombus 108. The capture device 306 can include a heating element. For example, the loop 312 can be heated, as shown in FIG. 31H. The loop 312 can be heated directly or indirectly using one or more energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, ultrasound, heated fluid, nuclei, and / or others. The loop 312 can be heated to a temperature as described herein. The entire loop 312 can be heated. Portions of the loop 312 can be heated while others are not. The inner-facing surface of the loop 312 can be heated. The heating loop 312 and bag 310 can be moved (e.g., retracted, pulled) proximally relative to the thrombus 108, as shown in FIG. 31H. The inner catheter 302 can be moved proximally along with the loop 312 and bag 310. The loop 312 can pass between the outer periphery of the thrombus 108 and the wall 118. The loop 312 can detach the thrombus 108 from the wall 118. The heat from the loop 312 can facilitate detachment of the thrombus 108 from the wall 118, which may be referred to as coring the thrombus 108 from the wall 118. The heat from the loop 312 can emulsify the thrombus 108, which may include emulsifying the periphery of the thrombus 108. The thrombus 108 can pass through the loop 312 and into the bag 310 as the loop 312 and bag 310 are retracted proximally, as shown in FIG. 31I. In some variations, the loop 312 can expand or contract in diameter with changes in the diameter of the vein 104 such that the loop 312 conforms to the wall 118. In some variations, the loop 312 can be a variable-sized loop.

[0317] 31J-31M illustrate the removal of the thrombus 108 by the capture device 306. As shown in FIG. 31J, the loop 312, bag 310, and / or inner catheter 302 can be retracted proximally to cause the thrombus 108 to move through the loop 312 and into the bag 310. The heat from the loop 312 can facilitate detachment of the thrombus 108 from the valve 110, which can include detachment without significant damage. Once the thrombus 108 is disposed within the bag 310, the temperature of the loop 312 can be reduced. For example, heating of the loop 312 can be stopped. The capture device 306 (e.g., the loop 312, bag 310, and / or inner catheter 302) and / or outer catheter 300 can be retracted proximally with the thrombus 108 disposed within the bag 310, as shown in FIGS. 31K and 31L, to remove the thrombus 108 from the collection site, as shown in FIG. 31M. The system 301, which may include an outer catheter 300, an inner catheter 302, and / or a capture device 306, is retracted proximally through the vein 104, as shown in FIG. 31N, and the thrombus 108 can be removed from the patient through an opening 313 (e.g., opening, hole, access location) within the patient, as shown in FIG. 31O.

[0318] In some variations, the capture device 306 can include a sheath 314, as shown in FIG. 32A. The sheath 314 can be disposed over the capture device 306. For example, the sheath 314 can be disposed over the bag 310 and / or loop 312 to prevent the bag 310 and / or loop 312 from expanding. The capture device 306 can be advanced distally to a location distal to the thrombus 108 with the sheath 314 positioned over the bag 310 and / or loop 312, as shown in FIG. 32B. Once the sheathed capture device 306 is positioned distal to the thrombus 108, the sheath 314 can be retracted proximally, releasing and expanding the bag 310 and / or loop 312, as shown in FIGS. 32C, 32D, and 32E. The loop 312 can be heated, as shown in FIG. 32F. The heating loop 312 can be retracted to the thrombus 108, as shown in Figure 32G. The heating loop 312 can separate the thrombus 108 from the wall 118, thus facilitating heat from the loop 312, as shown in Figure 32H. The thrombus 108 can then be removed as described herein.

[0319] In some variations, the loop 312 and / or bag 310 can include a diameter larger than the diameter of the vein 104, as shown in Figures 33A-33C. The loop 312 and / or bag 310 can be deployed distal to the thrombus 108, as shown in Figure 33A. The loop 312 can be heated, as shown in Figure 33B. The heated loop 312 can be retracted proximally to the thrombus 108, as shown in Figure 33C, to detach the thrombus 108 from the wall 118. The heat from the loop 312 can emulsify the thrombus 108, which can include emulsifying the periphery of the thrombus 108. The thrombus 108 detached from the wall 118 can be captured by the bag 310.

[0320] 34A-34H illustrate a system 301 having a heating port 316 (e.g., a funnel, cone, tube, orifice) that can be heated to at least the temperatures described herein. The port 316 can include multiple heating elements, including heatable ring elements, spots, wires, bands, etc. As shown in FIG. 34A, the port 316 can be located at the distal end of the outer catheter 300. In some variations, the port 316 can be located on a catheter, guidewire, suction device, and / or other device that is advanced to a location distal to the distal end of the outer catheter 300. In some variations, the port 316 can be a feature of the outer catheter 300. The capture device 306 can be located distal to the port 316. Once the thrombus 108 is positioned within the bag 310 of the capture device 306, the capture device 306 (e.g., the bag 310, the loop 312, and / or the inner catheter 302) can be moved proximally toward the mouth 316, as shown in FIG. 34B. The mouth 316 can be heated, as shown in FIG. 34C. The mouth 316 can be heated using techniques described herein. The heat from the mouth 316 can emulsify the thrombus 108. For example, as the thrombus 108 approaches and / or contacts the heated mouth 316, the heat from the mouth 316 can soften and / or emulsify the thrombus 108, which can facilitate the entry of the thrombus 108 into the outer catheter 300 through the mouth 316, as shown in FIGS. 34D, 34E, 34F, and 34G. The capture device 306 with the thrombus 108 can be retracted into the outer catheter 300 through the mouth 316. In some variations, the thrombus 108 can be aspirated into the outer catheter 300 through the heated port 316. Once the capture device 306 and thrombus 108 are positioned inside the outer catheter 300, the temperature of the port 316 can be reduced, as shown in Figure 34H. For example, the heating of the port 316 can be stopped.

[0321] In some variations, the system 301 can omit the capture device 306, as shown in FIGS. 35A-35F. As shown in FIG. 35A, the port 316 can be positioned proximal to the thrombus 108. As shown in FIG. 35B, the port 316 can be heated. The thrombus 108 can be aspirated through the port 316 into the outer catheter 300 for removal as the port 316 is advanced distally, as shown in FIGS. 35C, 35D, and 35E. Heating the port 316 can soften and / or emulsify the thrombus 108, thus facilitating aspiration through the port 316. The heat from the port 316 can facilitate detachment of the thrombus 108 from the wall 118 and facilitating aspiration into the outer catheter 300. Once the thrombus 108 is aspirated through the port 316 into the outer catheter 300, the temperature of the port 316 can be reduced, as shown in FIG. 35F. For example, the heat to the mouth 316 can be turned off.

[0322] 36 illustrates a system 318 (e.g., a thermal thrombectomy system, a thrombus removal system). The system 318 can be used to emulsify and / or aspirate a thrombus or other obstruction from a blood vessel. The system 318 can include more or fewer features than those shown. The system 318 can include any of the features described in connection with other systems, devices, and / or methods described herein.

[0323] The system 318 can include a thermal control system 380 (e.g., a temperature control system). The thermal control system 380 can control the temperature (e.g., heating) of a heating element (e.g., a loop, an orifice, etc.) to emulsify the thrombus. The thermal control system 380 can include a heater 385 (e.g., a variable current driver, a current driver) that can heat a heating element 386, which can include electrical heating. The heater 385 can heat the heating element 386 to at least the temperatures described herein or above to accommodate heat loss. Wiring for the heater 385 can be routed through the device interface 390 to a heating element (e.g., a loop, an orifice, etc.) that is positioned inside the patient's blood vessel. The heating element can be heated to at least the temperatures described herein.

[0324] The thermal control system 380 can include a temperature sensor interface 384 (e.g., a thermocouple interface, a T-type thermocouple interface). The temperature sensor interface 384 can interface with one or more temperature sensors 388 (e.g., thermocouples). The temperature sensors 388 can sense the temperature at or near the heating element (e.g., loop, port, etc.) and / or at or near the interface between the heating element and a thrombus disposed inside the patient's blood vessel. Wiring for the temperature sensor 388 can be routed through the device interface 390 to or near the heating element (e.g., loop, port, etc.). The thermal control system 380 can modulate the heat of the heating element based on the temperature and / or pressure sensed at the heating element and / or the interface between the heating element and the thrombus.

[0325] The system 318 can include a pneumatic system 320 (e.g., a suction system). The pneumatic system 320 can be used to aspirate thrombus and / or other occlusions from the patient's blood vessels. The pneumatic system 320 can include a pump 326 (e.g., a vacuum pump), an accumulator 324, a safety valve 322, a pressure gauge 328, a filter 330, a reservoir 332, and / or a valve 334 (e.g., a solenoid valve 334). The reservoir 332 can receive aspirated material (e.g., thrombus and / or other occlusive material). The system 318 can include a gauge to indicate the fill level of the reservoir 332, which can include a gauge on the user interface 372. The pneumatic system 320 can be operably coupled to a device interface 390 to facilitate suction.

[0326] The system 318 can include a pneumatic control system 336 (e.g., a suction control system). The pneumatic control system 336 can include a pump driver 338. The pump driver 338 can drive the vacuum pump 326. The pneumatic control system 336 can include a pressure sensor 342 that can sense the thermal control system 380 and / or intravascular pressure. The pneumatic control system 336 can include a valve actuation unit 344 that can actuate (e.g., open or close) the solenoid valve 334. The pneumatic control system 336 can include a pressure safety unit 340 that can monitor the thermal control system 380 and / or intravascular pressure. The pressure safety unit 340 can initiate a safety protocol (e.g., stop the driving of the vacuum pump 326 by the pump driver 338) when a certain pressure is detected.

[0327] The system 318 may include a power system 346. The power system 346 may include a battery 348, which may be rechargeable. The power system 346 may include a gauge 350. The gauge 350 may indicate a status of the battery 348 (e.g., a charge percentage, etc.). The power system 346 may include a charging interface 354. The charging interface 354 may interface with a cable 358 (e.g., a charging cable) that may interface with a power source 360 ​​(e.g., an outlet) to charge the battery 348 and / or directly power the system 318. The power system 346 may include a power management unit 356 and / or a voltage regulator 352.

[0328] The system 318 may include a control system 362. The control system 362 may perform the methods described herein. The control system 362 may include a microcontroller 364, a real-time clock 368 (e.g., RTC), and / or a memory 366. The real-time clock 368 may be used to monitor the duration of the methods and / or method steps described herein (e.g., the duration a heating element is at a certain temperature). The real-time clock 368 may be used to identify trigger events to which the system 318 responds. The system 318 may include a data interface 370, which may facilitate connecting the system 318 to a computing system for communicating data.

[0329] The system 318 can include a user interface system 372. The user interface system 372 can include one or more buttons 374 that can be used to at least adjust the temperature of the heating element, start / stop heating and / or suction, change modes, open and / or shut off valves, turn power on / off, and / or make other adjustments. The user interface system 372, in some variations, can include dials, switches, displays, touchpads, touchscreens, knobs, triggers, indicators, gauges, sliders, and / or other features. The user interface system 372 can include indicators 376 (e.g., indicator lights such as LEDs). The indicators 376 can visually indicate when the system 318 is ready to operate and / or when it is not ready to operate. The indicators 376 can visually indicate when the system 318 is suctioning and / or heating. The indicators 376 can indicate the charge level of the battery 348. The indicator 376 can indicate when the system 318 is communicating (e.g., transmitting data) with another computing system. The indicator 376 can emit an alarm. The indicator 376 can emit light of various colors and / or patterns. The user interface system 372 can include a speaker 532 (e.g., a buzzer) that can emit audible sounds to communicate warnings, alerts of safety issues, and / or emit sounds when various actions are performed (e.g., power on / off). In some variations, the user interface system 372 can include one or more displays, a touchscreen, a microphone for spoken commands, etc. In some variations, the indicator 376, speaker 378, display, touchscreen, etc. can indicate the status of the system 318, which can include at least indicating when the heating element is heated, the amount of time the heating element has been at or above a certain temperature, the temperature of the heating element, when the system 318 is applying suction, etc.

[0330] In some variations, system 318 may include wired and / or wireless communication interfaces for communicating with other computing devices. System 318 may include a processor and / or other hardware for performing the methods described herein.

[0331] 37 shows a device interface 390. The device interface 390 can be operably coupled to the outer catheter 300. As described herein, the orifice 316 can be located at the distal end of the outer catheter 300. A heater 385 (e.g., a variable current driver) can heat the orifice 316 as described herein. The heater 385 can include wiring that is routed through the outer catheter 300 to heat the orifice 316. A temperature sensor 388 (e.g., a thermocouple) can be located proximate to the orifice 316 to sense temperature. The temperature sensor 388 can include wiring that is routed through the outer catheter 300 to position the temperature sensor 388 at the orifice 316.

[0332] 38 illustrates a thermal controller system 400 (e.g., a thermal thrombectomy control system, a thermal thrombectomy system, a thrombectomy system, a system). The thermal controller system 400 can be used to emulsify a thrombus or other blockage in a blood vessel. The thermal controller system 400 can include more or fewer features than those shown. The thermal controller system 400 can include any of the features described in connection with other systems, devices, and / or methods described herein. The thermal controller system 400 can include a custom printed circuit board assembly (PCBA) and / or firmware.

[0333] The thermal controller system 400 can include a heater 412 (e.g., a variable heater current driver). The variable heater current driver 412 can heat the heating element (e.g., loop, mouth, etc.) by way of a conduit 422 (e.g., wire) routed to or adjacent to the heating element. The variable heater current driver 412 can heat the heating element to at least the temperatures described herein.

[0334] The thermal controller system 400 may include a temperature sensor interface 414 (e.g., a T-type temperature sensor interface chip). The temperature sensor interface 414 may be operably connected to a temperature sensor (e.g., a thermocouple) by one or more wires 422 or the like. The temperature sensor may be positioned proximate to the heating element, which may include proximate to the interface between the heating element and a thrombus or other occlusion. The thermal controller system 400 may include a safety sensing unit 416 that may monitor the temperature sensed by the temperature sensor. The safety sensing unit 416 may trigger a safety protocol based on the temperature sensed by the temperature sensor, which may include stopping the variable heater current driver 412 from heating the heating element, generating an alert, etc.

[0335] The thermal controller system 400 may include a microcontroller 406, a data interface 410 (e.g., a USB interface), and / or a memory 408. The data interface 410 may be used to connect the thermal controller system 400 to a computing system. In some variations, the thermal controller system 400 may include a wireless data interface that allows the thermal controller system 400 to wirelessly communicate with the computing system. The thermal controller system 400 may include a memory 408. The memory 408 may include instructions, protocols, etc. The memory 408 may include a log of data for the thermal controller system 400 (which may include temperature data, usage data, etc.).

[0336] The thermal controller system 400 can include a power management unit 402. The thermal controller system 400 can include a battery 404, which can be a rechargeable battery (e.g., a medical-grade rechargeable battery). The power management unit 402 can manage the current drawn from the battery 404.

[0337] The thermal controller system 400 can include a user interface 418, which can be custom. The user interface 418 can be used to control the thermal controller system 400. The user interface 418 can allow the thermal controller system 400 to communicate with a user. The user interface 418 can include lights (e.g., LEDs), buttons, dials, switches, displays, touchpads, touchscreens, knobs, triggers, indicators, gauges, sliders, speakers, buzzers, etc. The user interface 418 can allow a user to adjust the temperature of the heating element (e.g., allowing for 2°C adjustments, 1°C adjustments, or even smaller incremental adjustments). The user interface 418 can indicate the charge level of the battery 404.

[0338] The thermal controller system 400 can include a short circuit detection system. The thermal controller system 400 can include short circuit interruption. The thermal controller system 400 can include insulation fault detection. The thermal controller system 400 can include overheat protection for the catheter tip and / or electronics in the handle of the thermal controller system 400.

[0339] FIG. 39A illustrates a system 426 (e.g., a thermal thrombectomy system, thrombectomy system) having a capture device 428 (e.g., an expandable device) and a thermal device 446 (e.g., a cutting device) deployable from a catheter 436. The capture device 428 can include a bag 430 (e.g., a mesh, net, cage, basket) that can capture the thrombus. The bag 430 can, in some variations, be self-expanding. The capture device 428 can include a loop 431 (e.g., a hoop, circle, lasso) that can be positioned at a proximal end of the bag 430. The loop 431 can be positioned at (e.g., around) a proximal opening to the bag 430. The loop 431 can be self-expanding. The capture device 428 can include a sheath 438. The sheath 438 can be positioned over the bag 430 and / or the loop 431. With the capture device 428 positioned distal to the distal end of the catheter 436, the sheath 438 can be retracted proximally to unsheath the bag 430 and loop 431, allowing the bag 430 and / or loop 431 to expand radially outward. The capture device 428 can include one or more wires 440. The one or more wires 440 can extend through the sheath 438 to the loop 431, which can be formed by the one or more wires 440. Wire segments 434 of the one or more wires 440 can extend between the loop 431 and the distal end 432 of the capture device 428, thereby providing rigidity to the bag 430. The distal end 432 can be rigid from the one or more wires 440. In some variations, one or more wires 440 is a single wire that extends from the sheath 438, forms a portion (e.g., half) of the loop 431, extends to the distal end 432, returns from the distal end 432, forms another portion (e.g., half) of the loop 431, and then extends back into the sheath 438. The loop 431 and / or bag 430 can be generally centered about the longitudinal axis of the catheter 436.In some variations, one or more of the wires 448 and / or portions thereof (e.g., loop 431, wire segment 434, and / or distal end 432) can be heated. The bag 430 can be tapered in a proximal-distal direction, with the circumference of the distal portion being smaller than the circumference of the proximal portion.

[0340] The thermal device 446 (e.g., a cutting device) can include a heating loop 444 (e.g., a hoop, a lasso). The loop 444 can be formed from a wire 448. The wire 448 can be routed distally to form the loop 444, and then routed proximally. The loop 444 can include a distally extending portion 442. The distally extending portion 442 can be disposed on top of the loop 444. The distally extending portion 444 can include a U-shaped bend in the wire 448, thus facilitating distal movement of the loop 444. The wire 448 can be routed distally to form a portion (e.g., half) of a loop, extend distally, loop back proximally to form the distally extending portion 444 (e.g., the U-shaped bend), form another portion (e.g., half) of a loop, and routed proximally. Loop 444 may be generally centered about the longitudinal axis of catheter 436. A proximal portion of wire 448 may be disposed inside a material (e.g., cased), which may be insulating. Loop 444 and / or loop 431 may be distally angled (e.g., angled distally). In some variations, catheter 436 may be routed through another catheter to the thrombus. In some variations, a wire (e.g., a guidewire), which may be heated, may be routed through the catheter to the thrombus, rather than through catheter 436.

[0341] As described herein, a heating element (e.g., a heating wire, a heating guidewire) can be advanced distally through the catheter 436 or another catheter to the thrombus or other occlusion. The heating element can be heated and advanced to penetrate the thrombus. The heat can facilitate penetration of the thrombus by the heating element. The distal end of the catheter 436 can be proximal to the distal end of the heating element. The heating element and the distal end of the catheter 436 can be advanced distally of the thrombus. In some variations, the distal end 442 of the thermal device 446 can be advanced distally of the catheter 436 to penetrate the thrombus and heated, instead of using a separate heating element (e.g., a heating wire, a heating guidewire). The heat from the distal end 442 of the thermal device 446 can facilitate penetration of the thrombus. The distal end 442 and the distal end of the catheter 436 can be advanced distally of the thrombus.

[0342] The sheathed capture device 428 can be advanced distally from the catheter 436. The sheath 438 can be retracted proximally to unsheath the capture device 428 (e.g., the bag 430 and the loop 431) and allow the capture device 428 (e.g., the bag 430 and the loop 431) to self-expand. The thermal device 446 can be advanced from the catheter 436 and allow the loop 444 to self-expand. The loop 444 can be heated and retracted proximally to the thrombus. The heating loop 444 can detach the thrombus from the vessel wall. The heating loop 444 can emulsify the thrombus (e.g., around the thrombus). The capture device 428 can be retracted proximally to capture the thrombus that has detached from the vessel wall. With the thrombus within the bag 430, the capture device 428, the thermal device 446, and / or the catheter 436 can be retracted proximally from the patient to remove the thrombus.

[0343] 39B shows a cross section of the system 426. As shown, the capture device 428 can be disposed inside a lumen 450 (e.g., a tube, a circular tube, a round tube) of the catheter 436. The wire 440 of the capture device 428 (e.g., loop 431) can be collapsed (e.g., in an unexpanded configuration) within a sheath 438 disposed within the lumen 450. As shown, the catheter 436 can include a lumen 452 (e.g., a tube, a crescent-shaped tube) through which a thermal device 446 and / or other devices (e.g., a guidewire, a heated guidewire) can be routed. The thermal device 446 can include a conductive wire 447 that conducts heat to the wire 448 that forms the loop 444. The thermal device 446 can include a temperature sensor wire 454 (e.g., a thermocouple wire). The conductive wire 447 and / or the temperature sensor wire 454 can be disposed inside a casing 456 (e.g., an insulator, a cover), which can be made from a variety of materials (e.g., epoxy).

[0344] 39C shows a cross section of thermal device 446. As shown, wire 447 can include an insulating jacket 449 (e.g., casing, cover). Wire 447 and / or temperature sensor wire 454 can be disposed within casing 456, which can be disposed inside casing 458 (e.g., insulator, cover), which can be made from a variety of materials (e.g., epoxy).

[0345] FIG. 39D shows a cross section of thermal device 446 with exemplary dimensions. The listed dimensions can be at least half to twice the listed size. In some variations, insulating jacket 449 can be nominally 0.003 inches thick. Wire 447 can have a diameter of 0.010 inches. Temperature sensor wire 454 (e.g., Type T or K) can be 0.004 inches in diameter. Wire 448 forming loop 444 can be 0.020 inches in diameter. Wire 448 can be made of nickel titanium (i.e., nitinol). As shown in FIG. 39E, connection 451 can be used to operably connect wire 447 and wire 448. Connection 451 can be crimped and / or soldered to operably couple wire 447 and wire 448. The temperature sensor wire 454 can extend to a distal end 460 (e.g., a sensing end) that can be located proximate the junction between the wires 448 that form the loop 444. Sensing can occur at the distal end 460, which can be located distal to the casing 456.

[0346] FIG. 39F shows a portion of thermal device 446 within casing 458, which may be epoxy. Temperature sensor wire 454 may use T-type thermocouple wire, which may allow for accurate sensing independent of the Nitinol temperature coefficient. Temperature sensor wire 454 may include a diameter of 0.0045 inches. Temperature sensor wire 454 may be insulated (e.g., film insulated). As shown, connection 451 between wire 447 and wire 448 may be located distal to casing 456. Connection 451 may be located within casing 458. In some variations, distal end 460 may be located proximate to the distal end of casing 458. In some variations, distal end 460 may be located distal to the distal end of casing 458.

[0347] 40A-40C illustrate a thermal device 461 (e.g., a cutting device). As shown in FIG. 40A, the thermal device 461 can include a loop 462 (e.g., a hoop, a lasso). The loop 462 can include a distal end 464 (e.g., a distally extending portion). The distal end 464 can include a U-shaped bend in the wire forming the loop 462, thereby facilitating distal movement of the loop 462. The distal end 464 can be positioned on top of the loop 444. The wire forming the loop 462 can form a portion (e.g., half) of the loop 462, extend distally, loop back proximally, form the distal end 464 (e.g., the U-shaped bend), and form another portion (e.g., half) of the loop 462. The loop 462 can be coupled to one or more stiffeners 468 (e.g., stainless steel stiffeners). A covering (e.g., shrink, polytetrafluoroethylene shrink) can be disposed over the proximal portion of the wire forming the loop 462, the stiffener 468, and / or the conductive wire operably connected to the loop 462 to facilitate heating of the loop 462. The loop 462 can be heated to a temperature described herein. The loop 462 can emulsify thrombus and / or other occlusions within the vessel. The loop 462 can detach the thrombus from the vessel wall. As shown in FIG. 40B , the thermal device 461 can include a sheath 470, which can be various sizes (e.g., 6 Fr). The loop 462 can be retracted into the sheath 470, thereby collapsing the loop 462. The sheath 470 can be disposed over the loop 462 to prevent expansion. The sheath 470 can be retracted proximally to unfold (e.g., expose) the loop 462. The unsheathed loop 462 may be self-expanding (e.g., expanding radially outward). As shown in FIG. 40C, the thermal device 461 may include a casing 472 (e.g., an insulator, a jacket). The casing 472 may be disposed over a proximal portion of the wire forming the loop 462. The casing 472 may be disposed over at least a portion of the stiffener 468.The casing 472 may be placed over a conductive wire operably coupled to the loop 462 .

[0348] 41A and 41B illustrate a system 474 (e.g., a thermal thrombectomy system, thrombectomy system, capture device, thermal device) that can be used to remove a thrombus and / or other obstruction from a blood vessel. The system 474 can include a capture device 484 (e.g., an expandable device). The capture device 484 can include a loop 478 (e.g., a hoop, a lasso) that can be heated. The capture device 484 can include a bag 480 (e.g., a mesh, a net, a cage, a basket). The bag 480 can be tapered in a proximal-distal direction. The loop 478 can be disposed at a proximal opening of the bag 480. The loop 478 can be integral with the bag 480. When deployed, the loop 478 can follow the periphery of the bag 480, defining an opening into the bag 480. The system 474 can include a catheter 476. The capture device 484 can be routed through the catheter 476 and deployed therefrom. For example, the distal end 482 of the capture device 484 can be advanced until the bag 480 and loop 478 are distal to the catheter 476, thus allowing the loop 478 and / or bag 480 to freely self-expand. In some variations, a wire can extend between the loop 478 and the distal end 482. In some variations, the wire can be heated.

[0349] In use, a heating element (e.g., a wire, a guidewire) is positioned distal to the catheter 476 and can be in interface contact with the thrombus. The heating element can penetrate the thrombus. Heat from the heating element can facilitate penetration, which can include emulsifying the thrombus (e.g., the central portion of the thrombus). The heating element can pass over (e.g., through) the thrombus to reach a distal portion of the thrombus. The catheter 476 with the capture device 484 disposed therein can be advanced with or after the heating element such that the distal end of the catheter 476 is distal to the thrombus. The capture device 484 can be advanced from the catheter 476 to deploy (e.g., self-expand) distal to the thrombus. The loop 478 can be heated. The heating loop 478, integrated with the bag 480, can be retracted proximally. The heating loop 478 can be in interface contact with the thrombus, which can include emulsifying the thrombus. The heating loop 478 can detach the thrombus from the vessel wall. The thrombus can be trapped within bag 480. System 474 can be retracted proximally from the patient with the thrombus within bag 480. In some variations, distal end 482 can be heated in place of or in combination with a separate heating element and advanced distally of catheter 476 to penetrate the thrombus and facilitate thrombus crossover.

[0350] 42A and 42B illustrate a system 486 (e.g., a thermal thrombectomy system, thrombectomy system, capture device, thermal device) that can be used to remove a thrombus and / or other obstruction from a blood vessel. The system 486 can include a thermal device 491 (e.g., a cutting device). The thermal device 491 can include a loop 498 (e.g., a hoop, a lasso) that can be heated. The thermal device 491 can include one or more wires 496 that can extend to and form the loop 498. The system 486 can include a capture device 490 (e.g., an expandable device). The capture device 490 can include a bag 492 (e.g., a mesh, a net, a cage, a basket). The bag 492 can taper in a proximal-distal direction. The bag 492 can include a perimeter of a consistent size and then taper in a proximal-distal direction. The bag 492 can include a proximal opening that can include a loop 493 (e.g., a wire loop). The thermal device 491 and the capture device 490 can be integrated (e.g., coupled, connected) together. For example, a wire segment 500 (e.g., tether, connection, boom, extension boom) can couple the loop 498 of the thermal device 491 to the bag 492 (e.g., loop 493) of the capture device 490. In some variations, the wire segment 500 (boom, extension boom) can extend from the loop 498 to the distal end 494 of the capture device 490 (e.g., bag 492). In some variations, heat from the loop 498 can be conducted to the capture device 490, which can include at least the bag 492 and / or the distal end 494. The distal end 494 can be rigid. The wire segment 500 can be positioned on top of the loop 498. Another wire segment or tether 501 can couple the loop 498 and the bag 492. Another wire segment or tether 501 may be positioned on the opposite side of loop 498 relative to wire segment 500 .

[0351] In use, a heating element (e.g., a wire, a guidewire) can be positioned distal to the catheter 488 and interface with the thrombus. The heating element can penetrate the thrombus. Heat from the heating element can facilitate penetration, which can include emulsifying the thrombus (e.g., the central portion of the thrombus). The heating element can extend beyond (e.g., through) the thrombus to reach a distal portion of the thrombus. The catheter 488, having the capture device 490 and the thermal device 491 disposed therein, can be advanced with or after the heating element such that the distal end of the catheter 488 is distal to the thrombus. The heating element can be retracted proximally into the catheter 488. The capture device 484 and the thermal device 491 coupled to the capture device 484 can be advanced from the catheter 488 to deploy (e.g., self-expand) distal to the thrombus. The loop 498 can be heated. In some variations, the bag 492, or portions thereof, can be heated. The loop 498 and the capture device 490 can be coupled together, which can include being coupled (e.g., connected, tethered) together. The thermal device 491 and the capture device 490 can be retracted proximally together such that the loop 498 of the thermal device 491 comes into interfacial contact with the thrombus, thereby emulsifying the thrombus (e.g., around the thrombus) with heat from the loop 498. The heat from the loop 498 can help detach the thrombus from the vessel wall. The thrombus can be captured within the bag 492. With the thrombus captured within the bag 492, the thermal device 491 and the capture device 490 can be retracted proximally from the patient to remove the thrombus. In some variations, the distal end 494 can be heated instead of or in combination with a separate heating element and advanced distally of the catheter 488 to penetrate the thrombus and facilitate its passage.

[0352] 43A and 43B illustrate a system 502 (e.g., a thermal thrombectomy system, thrombectomy system, capture device, thermal device) that can be used to remove a thrombus and / or other obstruction from a blood vessel. The system 502 can include a thermal device 505 (e.g., a cutting device). The thermal device 505 can include a loop 508 (e.g., a hoop, a lasso) that can be heated. The loop 508 can include a distal end 512 (e.g., a distally extending portion). The distal end 512 can be located at a top of the loop 508. The distal end 512 can include a U-shaped bend in the wire 510 that forms the loop 508, which can facilitate distal movement of the thermal device 505. Wire 510 may be routed distally, form a portion (e.g., half) of loop 508, extend distally, loop back proximally to form distal end 512, form another portion (e.g., half) of loop 462, and be routed proximally. Loop 508 may be generally centered about the longitudinal axis of catheter 506. The proximal portion of wire 510 may be disposed inside (e.g., wrapped in) a material that may be insulating.

[0353] The system 502 may include a capture device 504. The capture device 504 may include a bag 518 (e.g., a mesh, net, cage, basket). The bag 518 may be tapered in a proximal-distal direction. The capture device 504 may include one or more wires 514. The wires 514 may be routed through the catheter 506 to allow a surgeon to manipulate the capture device 504. The wires 514 may form a loop 516 (e.g., a hoop, a lasso) at an opening to the bag 518. The wires 514 may extend from the loop 516 at the opening of the bag 518 to a distal end 520 of the capture device 504 (e.g., the bag 518), which may be referred to as an extension boom and / or boom. The distal end 520 of the capture device 504 may be rigid, and the rigidity may be provided by the wires 514. The opening to the bag 518 may be generally centered about the longitudinal axis of the catheter 506. In some variations, the wire 514 can be heated.

[0354] In use, the heating element (e.g., wire, guidewire) is positioned distally relative to the catheter 506 and can interface with the thrombus. The heating element can penetrate the thrombus. Heat from the heating element can facilitate penetration, which can include emulsification of the thrombus (e.g., the central portion of the thrombus). The heating element can pass over (e.g., through) the thrombus to reach a distal portion of the thrombus. The catheter 506, having the thermal device 505 and capture device 504 disposed therein, can be advanced with or after the heating element such that the distal end of the catheter 506 is distal to the thrombus. The thermal device 505 and / or capture device 504 can be advanced from the catheter 506 to deploy (e.g., self-expand) distal to the thrombus. The loop 508 can be heated. The heating loop 508 can be retracted proximally. The heating loop 508 can interface with the thrombus, which can include emulsification of the thrombus. The heating loop 508 can detach the thrombus from the vessel wall. The thrombus can be trapped within the bag 518. The system 502 can be retracted proximally from the patient with the thrombus within the bag 518. In some variations, the distal end 520 and / or the distal end 512 can be heated and advanced distally of the catheter 506 in place of or in combination with a separate heating element to penetrate the thrombus and facilitate its passage.

[0355] 44A and 44B illustrate a system 522 (e.g., a thermal thrombectomy system, thrombectomy system, capture device, thermal device) that can be used to remove a thrombus and / or other obstruction from a blood vessel. The system 522 can include a thermal device 525. The thermal device 525 can include a loop 534 (e.g., a hoop, a lasso) that can be heated. The loop 534 can include a distal end 536 (e.g., a distally extending portion). The distal end 536 can be located at a top of the loop 534. The distal end 536 can include a U-shaped bend in the wire 535 that forms the loop 534, thus facilitating distal movement of the thermal device 525. The wire 535 can be routed distally, form a portion (e.g., half) of the loop 534, extend distally, loop back proximally to form the distal end 536, form another portion (e.g., half) of the loop 534, and be routed proximally. The loop 534 may be generally centered about the longitudinal axis of the catheter 532. The proximal portion of the wire 535 may be disposed inside a material that may be insulating (e.g., encased).

[0356] The system 522 can include a capture device 524 (e.g., an expandable device). The capture device 524 can include a bag 526 (e.g., a mesh, net, cage, basket). The bag 526 can include a distal end 528 that can be rounded. The bag 526 can include a generally consistent sized circumference. The capture device 524 can include one or more wires 530. The wires 530 can be routed through a catheter 532 to allow a surgeon to manipulate the capture device 524. The wires 530 can form a loop 538 at an opening to the bag 526. The opening to the bag 526 can be generally centered about the longitudinal axis of the catheter 532. In some variations, the wires 530 can be heated. In some variations, a portion of the wires 530 extending around the opening into the bag 526 that forms the loop 538 can be heated. The capture device 524 can include a sheath 540. A sheath 540 can be placed over the bag 526 to prevent expansion of the bag 526. The sheath 540 can be retracted proximally to uncover the bag 526. The unsheathed bag 526 can be self-expanding. For example, the portion of the wire 530 that extends around the opening of the bag 526 forming the loop 538 can be self-expanding.

[0357] In use, a heating element (e.g., a wire, a guidewire) can be positioned distal to the catheter 532 and interface with the thrombus. The heating element can penetrate the thrombus. Heat from the heating element can facilitate penetration, which can include emulsifying the thrombus (e.g., the central portion of the thrombus). The heating element can extend beyond (e.g., pass through) the thrombus to reach a distal portion of the thrombus. The catheter 532, having the thermal device 525 and capture device 524 disposed therein, can be advanced with or after the heating element such that the distal end of the catheter 532 is distal to the thrombus. The thermal device 525 and / or capture device 526 can be advanced out of the catheter 506. The sheath 540 of the capture device 524 can be retracted. The unsheathed bag 526 can expand (e.g., self-expand). The loop 534 can be heated. The heating loop 534 can be retracted proximally. The heating loop 534 can interface with the thrombus, which can include emulsifying the thrombus. The heating loop 534 can detach the thrombus from the vessel wall. The thrombus can be captured within the bag 526. The system 522 can be retracted proximally from the patient with the thrombus within the bag 526. In some variations, the distal end 536 can be heated and advanced distally of the catheter 532 in place of and / or in combination with a separate heating element to penetrate the thrombus and facilitate its passage.

[0358] FIG. 45 illustrates a capture device 542 (e.g., an expandable device) that can be used to emulsify and / or capture and remove thrombus and / or other obstructions. The capture device 542 can include a bag 548 (e.g., a mesh, net, cage, basket, stent). The bag 548 can include a lattice (e.g., a matrix) of struts. The bag 548 can be made of various materials (e.g., shape memory alloys such as nickel titanium). The bag 548 can include a distal end 552. The distal end 552 can include a rigid nose (e.g., a tail). The distal end 552 can include an annular ring shape. The bag 548 can include a loop 544 (e.g., a proximal loop, hoop, lasso) that can define an opening (e.g., a proximal opening) to the bag 548. The loop 544 can be collapsible. A heating element 546 (e.g., a wire) can be disposed in the loop 544. The heating element 546 can include a loop shape that can follow the loop 544. The heating element 546 can be disposed along the inner circumference of the loop 544. The heating element 546 can emulsify the thrombus (e.g., emulsify around the thrombus). The heating element 546 can detach the thrombus from the vessel wall. The heating element 546 can be heated by various techniques, including electrical current. The loop 544 can include larger struts to provide less resistance. In some variations, some electrical current can flow through the bag 548, thus heating the bag 548. The thrombus can be trapped within the bag 548. The bag 548 can include a cover 550 (e.g., wrapping, jacket). The cover 550 can be uncovered, leaving the heating element 546 exposed. The cover 550 can be uncovered, leaving the distal end 552 exposed. The cover 550 can be made from a variety of materials, which can include at least expanded polytetrafluoroethylene and / or polytetrafluoroethylene.In some variations, the capture device 542 may include a sheath that can be retracted to expand the capture device 542. The capture device 542 may be deployed from a catheter.

[0359] In use, a heating element (e.g., a wire, a guidewire) can be positioned distal to the catheter and interface with the thrombus. The heating element can penetrate the thrombus. Heat from the heating element can facilitate penetration, which can include emulsifying the thrombus (e.g., the central portion of the thrombus). The heating element can extend beyond (e.g., pass through) the thrombus to reach a distal portion of the thrombus. A catheter having a capture device 542 disposed therein can be advanced with or after the heating element such that the distal end of the catheter is distal to the thrombus. The capture device 542 can be advanced from the catheter to deploy (e.g., expand, self-expand) distal to the thrombus. In some variations, the capture device 542 can be disposed within a sheath. The sheath can be retracted to uncover the capture device 542 so that the capture device 542 expands (e.g., self-expands). The heating element 546 can be heated. Capture device 542 can be retracted proximally, bringing heating element 546 into interfacial contact with the thrombus, thereby emulsifying the thrombus (e.g., around the thrombus). Heating element 546 and / or loop 544 can detach the thrombus from the vessel wall. The thrombus can be captured within bag 548. Capture device 542, along with the thrombus within bag 548, can be retracted proximally from the patient. In some variations, distal end 552 can be heated in place of or in combination with a separate heating element and advanced distally of the catheter to penetrate the thrombus and facilitate its passage.

[0360] 46A-46F illustrate emulsification of a thrombus during clinical testing. FIG. 46A illustrates a chronic thrombus 109 disposed within a tube 558 prior to exposure to heat from a heating element 556. FIG. 46B illustrates the chronic thrombus 109 after approximately one minute of exposure to a heating element 556 heated to approximately 70° Celsius. As shown, a portion of the chronic thrombus 109 has emulsified after approximately one minute of exposure, as evidenced by emulsified thrombus 554 (e.g., melting, liquefaction). FIG. 46C illustrates the chronic thrombus 109 after approximately two minutes of exposure to a heating element 556 heated to approximately 70° Celsius. As shown, a larger portion of the chronic thrombus 109 has emulsified after approximately two minutes of exposure, as evidenced by emulsified thrombus 554. FIG. 46D illustrates the chronic thrombus 109 after approximately three minutes of exposure to a heating element 556 heated to approximately 70° Celsius. As shown, a larger portion of chronic thrombus 109 has emulsified after about three minutes of exposure, as seen by emulsified thrombus 554. FIG. 46E shows chronic thrombus 109 after about four minutes of exposure to heating element 556 heated to about 70° Celsius. As shown, a larger portion of chronic thrombus 109 has emulsified after about four minutes of exposure, as seen by emulsified thrombus 554. FIG. 46F shows chronic thrombus 109 after about five minutes of exposure to heating element 556 heated to about 70° Celsius. As shown, chronic thrombus 109 has substantially emulsified after about five minutes of exposure, as seen by emulsified thrombus 554.

[0361] 47-51 illustrate the distal tip (e.g., tip, distal portion, distal end) of a heating element (e.g., wire, guidewire, guide device, thermal device, cutting device, capture device, and / or other device) that can be used to penetrate and / or coring a thrombus and / or other occlusion within a blood vessel. Various types of distal tips can be employed, including spring-loaded, rounded, balloon-spacing, round wire, coil, and / or auger. For balloon spacing, a balloon catheter can be deployed to space the heating element away from the vessel wall. The distal tip can be self-centering. The distal tip increases the surface area of ​​interfacial contact with the thrombus, resulting in emulsification.

[0362] 47 shows a distal tip 560 that can be heated. The distal tip 560 can include a coil 562 (e.g., a helix). The coil 562 can be a coiled wire. The coil 562 can be radially largest at a midsection (e.g., tapered in size relative to the midsection in the distal and proximal directions). The coil 562 can be generally spherical. The coil 562 can be disposed on a member 563 (e.g., a wire, a guidewire).

[0363] 48A and 48B show a distal tip 564 that can be heated. The distal tip 564 can include a plurality of looped wires 566 (e.g., looped members). The looped wires 566 can start at a proximal location, extend distally, and loop back proximally to a proximal location. The looped wires 566 can be disposed on a member 567 (e.g., a wire, a guidewire). The looped wires 566 can include an end coupled to the member 567.

[0364] 49 shows a distal tip 568 that can be heated. The distal tip 568 can include a coil 570 (e.g., a helix). The coil 570 can be a coiled (e.g., helical) wire. The helix 570 can be tapered. The helix 570 can increase in radial size distally. The distal tip 568 can be disposed on a member (e.g., a wire, a guidewire).

[0365] 50 shows a distal tip 572 that can be heated. The distal tip 572 can include a looped wire 574. The looped wire 574 can be coupled to a member 576 (e.g., a wire, a guidewire). The looped wire 574 can be coupled to the member 576 using a sleeve 578 (e.g., a band, a cover). The sleeve 578 can be disposed around the member 576. The looped wire 574 can extend from a distal end of the sleeve 578 and loop back into a proximal end of the sleeve 578.

[0366] FIG. 51 illustrates a distal tip 580 that can be heated. The distal tip 580 can include a member 582 (e.g., a housing, a carrier, a tube, a catheter). A surface 584 (e.g., a button, a switch) can be disposed inside the member 582. The surface 584 can be heated. The member 582 can be insulated. The surface 584 can be deployed from within the member 582 to interface with the thrombus. The surface 584 can include a larger contact area to transfer heat to the thrombus. The surface 584 can be deployed using a spring. The surface 584 can be deployed to be flush with the surrounding surface of the member 582. The surface 584 can be deployed to be distal to the surrounding surface of the member 582. The surface 584 can be circular.

[0367] A thrombus may be heterogeneous. Different regions of the thrombus may emulsify at different rates at different temperatures. In some variations, it may be beneficial to vary the temperature of a heating element (e.g., wire, loop, mouth, funnel, etc.) based on the characteristics of the thrombus at the interface between the thrombus and the heating element. For example, it may be beneficial to increase the temperature of a heating element when interfacing with a region of the thrombus having chronic characteristics compared to when interfacing with a region of the thrombus having acute characteristics. In some variations, the systems and methods described herein may vary the temperature of a heating element based on the characteristics of the region of the thrombus with which the heating element is interfacing.

[0368] The wires and / or heating elements described herein can be made from a variety of materials, such as stainless steel, shape memory alloys (e.g., nickel titanium), etc. In some variations, voltage drop can be protected against through ground wire detection. In some variations, the heat (e.g., current) applied by the systems described herein can be controlled (e.g., modulated) through closed-loop techniques and / or artificial intelligence. In some variations, the type of material, clot, and / or occlusion being removed can be detected (e.g., remotely detected) through data, which may include using closed-loop techniques and / or artificial intelligence.

[0369] FIG. 52 illustrates a thermal thrombectomy system 600, which may also be referred to as a thermal thrombectomy device, a thermal device or system, a thermal crossing device or system, a crossing device or system, a thrombectomy catheter device or system, and / or a thermal catheter device or system. The thermal thrombectomy system 600 can be used to cross, which may include penetrating and / or passing through a thrombus or other obstruction within the body's vasculature. For example, the thermal thrombectomy system 600 can be used to pass from the proximal side to the distal side of the thrombus. Another device, such as a cutting device and / or a collection device, can also be introduced to cut and / or collect the thrombus. In some variations, the thermal thrombectomy system 600 can be used to disrupt (e.g., fragment) the thrombus. The thermal thrombectomy system 600 can also be used with any of the other devices and / or systems described herein. The thermal thrombectomy system 600 can include any of the features of the other devices and / or systems described herein.

[0370] As shown, the thermal thrombectomy system 600 can include a thermal assembly 602 (e.g., a traversing assembly, a thermal traversing assembly) and / or an anchoring assembly 603 (e.g., a balloon assembly, an expandable assembly). The thermal assembly 602 can be used to penetrate, traverse, and / or fragment the thrombus. The anchoring assembly 603 can be used to anchor the thermal thrombectomy system 600 within the vasculature to distally advance the thermal assembly 602 and facilitate penetration of the thrombus. The anchoring assembly 603 can be used to obstruct proximal flow of fluid and / or thrombus. The anchoring assembly 603 can be used to center the thermal assembly 602 (e.g., its heating element) within the vasculature.

[0371] The anchoring assembly 603 can include a sheath 628 (e.g., a tube, a catheter, an outer tube). The anchoring assembly 603 can include an expandable device 630 (e.g., a balloon, an umbrella). The expandable device 630 can be disposed on a distal portion of the sheath 628. When positioned within the vasculature so as to contact a vessel wall (e.g., a venous or arterial wall), the expandable device 630 can be expanded (e.g., inflated) to anchor the anchoring assembly 603 and / or the thermal thrombectomy system 600 in place within the vessel. The expanded expandable device 630 can obstruct the proximal flow of fluids, such as blood and / or thrombus. If the expandable device 630 is a balloon, it can be filled or emptied with gas and / or fluid to expand or deflate. If the expandable device 630 is an umbrella or the like, it can be expanded using a shape memory material or other techniques. Expandable device 630, when expanded into contact with the vessel wall, can center anchoring assembly 603 (eg, sheath 628) within the vasculature.

[0372] The anchoring assembly 603 can include a connector 620 (e.g., a Y-coupling, coupler, Y-coupler, Y-connector). The connector 620 can be disposed in a proximal portion of a sheath 628. The connector 620 can include a port 622 (e.g., an angled port, an inlet, an inflation port). Gas and / or fluid can be introduced or removed through the port 622 of the connector 620 to inflate or deflate the expandable device 630. For example, gas and / or fluid can flow through the port 622 and the interior of the sheath 628 to inflate the expandable device 630.

[0373] Connector 620 can include a port 626 (e.g., a flush port, inlet, flush inlet). Fluid can be introduced into sheath 628 through port 626 to flush anchoring assembly 603 with air, reducing the risk of introducing air into the vasculature.

[0374] The connector 620 can include a port 623 (e.g., a straight port, a main port) that can receive the thermal assembly 602, a guidewire, and / or other devices therein.

[0375] The connector 620 can include a valve 624 (e.g., a Tuohy-Borst valve, adapter, Tuohy-Borst adapter) that can seal and / or clamp the thermal assembly 602, such as the tube 618 of the thermal assembly 602. The valve 624 can be disposed on a port 623.

[0376] The heat assembly 602 can be introduced through the anchoring assembly 603. For example, the heat assembly 602 can include a tube 618 (e.g., a catheter, an outer tube). The tube 618 can be advanced distally through the anchoring assembly 603. For example, the tube 618 can be advanced through a connector 620 (e.g., a port 623, a valve 624 on the port 623 of the connector 620) and a sheath 628 of the anchoring assembly 603. The tube 618 can be advanced distally through the sheath 628 such that a distal portion of the tube 618 can extend distally from the sheath 628 (e.g., distal to the distal end of the sheath 628).

[0377] The thermal assembly 602 can include a heating element 632 (e.g., an electrode, a heating wire, a heating tube, a heating loop, a heating element, a heating tip, a heating end, a heating distal portion, a heating distal end). The heating element 632 can be disposed on a distal portion of the tube 618 by advancing the tube 618 distally from the sheath 628 to position the heating element 632 distal to the distal end of the sheath 628. The heating element 632 can be heated directly or indirectly using one or more energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, induction heating, ultrasound, hot fluid, nuclei, and / or others. The heating element 632 can include various materials, which may include at least a shape memory material (e.g., a shape memory alloy, a shape memory polymer, nitinol, a nickel-titanium alloy), a metal, a metal alloy, a polymer, a ceramic, etc. The heating element 632 can be advanced into contact with the thrombus to facilitate penetration of the thrombus, soften and / or emulsify the thrombus, traverse the thrombus, and / or disrupt (e.g., fragment) the thrombus. The heating element 632 can be used to core the thrombus. The expanded expandable device 630 can anchor the thermal thrombectomy system 600 within the vasculature to facilitate advancement of the heating element 632 (e.g., to facilitate penetration of the thrombus). Wiring can be routed through the interior of the tubing 618 to the heating element 632.

[0378] The thermal assembly 602 can include a connector 604 (e.g., a Y-coupling, coupler, Y-coupler, Y-connector). The connector 604 can be disposed at a proximal portion of a tube 618. The connector 604 can include a port 606 (e.g., an angled port, an inlet, an inflation port). One or more conductors (e.g., wires) for the thermal thrombectomy system 600 can be routed through the port 606. For example, conduits for heating, temperature sensing, leakage current sensing, and / or a mechanical agitator can be routed through the port 606 into the tube 618.

[0379] The thermal assembly 602 can include a handpiece 616 (e.g., controller, handle). The handpiece 616 can include electronics (e.g., battery, rechargeable battery, controller, processor, memory, timer, wireless communication interface, transceiver, power interface, etc.) to facilitate the function of the thermal thrombectomy system 600 described herein. The handpiece 616 can be used to control the temperature of the heating element 632. For example, current can be applied to the heating element 632 from a battery in the handpiece 616. In some variations, current can be applied to the heating element 632 from an external power source. The electronics (e.g., controller) of the handpiece 616 can be used to automatically control the temperature of the heating element 632, and the control can be based on a sensed temperature and / or a sensed current leakage. For example, if the sensed temperature is above a threshold, the controller of the handpiece 616 can reduce the temperature of the heating element 632 (e.g., adjust the current and / or voltage to reduce the temperature). If the sensed temperature is below a threshold, the controller of the handpiece 616 can increase the temperature (e.g., adjust the current and / or voltage to increase the temperature) of the heating element 632. If a leakage current is sensed, the controller of the handpiece 616 can stop applying current to the heating element 632.

[0380] The thermal assembly 602 can include an electrical connector 614 (e.g., a push-pull latching electrical connector). Conduits for heating, temperature sensing, leakage current sensing, and / or a mechanical agitator can be connected to the electrical connector 614. The electrical connector 614 can be coupled (e.g., releasably coupled) to a handpiece 616. The conduits can be routed from the electrical connector 614 to the port 606 of the connector 604 by tubing 612 (e.g., flexible tubing, conduit, flexible conduit). The tubing 612 can be insulated.

[0381] The connector 604 can include a port 607 (e.g., a straight port, a main port). A hub 610 (e.g., a valve, a connector) can be disposed on the port 607.

[0382] A guidewire 608 (e.g., a wire) can be used to navigate the thermal thrombectomy system 600 to the thrombus. For example, the guidewire 608 can be routed through the patient's vasculature, and the thermal thrombectomy system 600 can be advanced over the guidewire 608. For example, the sheath 628 and / or the tube 618 can be advanced over the guidewire 608. The guidewire 608 can extend distally of the sheath 628 through the port 607, the hub 610, the tube 618, the port 623, the valve 624, and / or the sheath 628. The hub 610 can seal around the guidewire 608, thereby preventing fluid from leaking out.

[0383] 53A illustrates a handpiece 616 for the thermal thrombectomy system 600 (e.g., the thermal assembly 602 of the thermal thrombectomy system 600). As shown, the handpiece 616 can include a socket 636 (e.g., a connection feature, an interface) for coupling with an electrical connector 614 to electrically couple with one or more conduits within the tubing 612.

[0384] The handpiece 616 may include a button 634 or the like (e.g., a toggle, switch, dial, etc.) for activating (e.g., initiating heating) the heating element 632. In some embodiments, the handpiece 616 may include a display (e.g., a gauge) and / or other indicators that may indicate the sensed temperature at the heating element 632, the state (e.g., activated or deactivated) of the heating element 632 when a current leak is detected, and / or other characteristics of the thermal thrombectomy system 600. In some embodiments, the handpiece 616 may include a user interface (e.g., a button, touch screen, toggle, switch, dial) for setting a target temperature for the heating element 632.

[0385] FIG. 53B shows the heat assembly 602 with the handpiece 616 disconnected from the electrical connector 614, the tube 618 positioned outside the sheath 628 of the anchoring assembly 603, and the guidewire 608 removed.

[0386] 53C shows an expanded view of the connector 604 of the thermal assembly 602 and the components of the thermal thrombectomy system 600 disposed therein. As shown, the leakage conduit 640, the temperature sensor conduit 642 (e.g., a thermocouple conduit), and / or the heat conduit 644 can be routed through the tubing 612 to the port 606 of the connector 604. The conduits can be wires. The leakage conduit 640, the thermocouple conduit 642, and / or the heat conduit 644 can be routed through the port 606 into the tubing 618 (e.g., the proximal end of the tubing 618). The heat conduit 644 can deliver electrical current and / or other forms of energy to the heating element 632 to increase the temperature of the heating element 632. As shown, the thermal assembly 602 can include a tube 638 (e.g., a catheter, an inner tube) through which the guidewire 608 can be disposed. Tube 638 can be disposed within connector 604 (e.g., port 607, hub 610) and extend into tube 618 (e.g., through the proximal end of tube 618). In some embodiments, tube 638 can terminate and / or be sealed within connector 604 (e.g., port 607, hub 610). In some embodiments, hub 610 can be sealed around tube 638. Tube 618 can terminate at connector 604 (e.g., distal to port 606, at the distal end of connector 604).

[0387] 53D-53F illustrate a distal portion (e.g., crossing tip, heating tip) of the thermal assembly 602. As shown, the thermal assembly 602 can include a distal end 646 (e.g., distal tip) that can be reflowed. The distal end 646 can include generally rounded features. The distal end 646 can seal (e.g., plug) the distal portion of the tube 618. The distal end 646 can be a plug disposed on the tube 618. The distal end 646 can include an opening 648 (e.g., a hole) through which a guidewire 608 can be disposed (e.g., the thermal assembly 602 can be advanced distally over the guidewire 608 with the guidewire 608 disposed through the opening 648). The distal end 646 can include a heating element 632. The heating element 632 can be a loop (e.g., including a loop shape), which can be a nitinol loop. The heating element 632 can extend distally from a distal end 646 and curve back proximally to the distal end 646. In some embodiments, the distal end 646 can be formed around a proximal portion of a loop of the heating element 632. The heating element 632 can be coated with a parylene coating (e.g., a thin parylene coating) for insulation.

[0388] The thermal assembly 602 may include features for fluoroscopy and / or x-ray visualization. The thermal assembly 602 may include one or more features for detecting current leakage from the heating element 632. For example, the thermal assembly 602 may include an electrode and a marker, which may be the same feature. The thermal assembly 602 may include an electrode 650, which may be a band, an annular structure, and / or a ring. The electrode 650 may be disposed around the distal end 646. The electrode 650 may be disposed around the tube 618. The electrode 650 may be used for visualization to navigate through the vasculature, which may include at least fluoroscopy and / or x-ray visualization techniques. The electrode 650 may be used to detect current escape from the heating element 632. If current is detected (e.g., if current above a threshold is detected), the thermal assembly 602 may stop applying current to the heating element 632.

[0389] 53F, the fault conduit 640 can be electrically coupled (e.g., welded, crimped) to the electrode 650. The fault conduit 640 can be routed from the electrode 650 through the tubing 618 and back to the handpiece 616. The fault conduit 640 can communicate any fault current sensed by the electrode 650 to the electronics of the handpiece 616, which can automatically stop applying current to the heating element 632.

[0390] The thermal assembly 602 can include a temperature sensor 643 (e.g., a thermocouple). The temperature sensor 643 can be disposed on the heating element 632 to sense the temperature at the heating element 632. The temperature sensor 643 can be disposed inside the heating element 632. As shown in FIG. 53F , the heating element 632 can include an interior 633 (e.g., a hollow interior) in which the temperature sensor 643 can be disposed. A thermocouple conduit 642 can be routed from the temperature sensor 643 through the tubing 618, the connector 604 (e.g., port 606 of the connector 604), and the tubing 612, and back to the handpiece 616 to communicate the sensed temperature data.

[0391] The thermal assembly 602 may include insulation 652 (e.g., an insulating sleeve) on at least one of the legs of the heating element 632 (e.g., one of the legs of the loop of the heating element 632), which may help reduce the possibility of short circuits between the legs of the loop.

[0392] 54A shows the anchoring assembly 603 separate from the heat assembly 602. In some embodiments, the anchoring assembly 603 (e.g., sheath 628) can be advanced over the guidewire 608 to position the expandable device 630 proximal to the thrombus, and then the heat assembly 602 can be advanced through the sheath 628.

[0393] 54B shows a proximal portion of anchoring assembly 603. As shown, anchoring assembly 603 can include tubing 654 (e.g., catheter, inner balloon tube, inner tube). The proximal end of tubing 654 can terminate and / or be sealed in connector 620, which can include in port 623.

[0394] 54C and 54D , the tube 654 can extend within a distal portion of the sheath 628. The expandable device 630 (e.g., a balloon) can be disposed on the distal portion of the sheath 628. The sheath 628 can include one or more openings 656 (e.g., holes), which can include two holes through which a gas or fluid can flow to inflate or deflate the expandable device 630. The fluid can flow through a gap 662 (e.g., a radial gap) between the outer surface of the tube 654 and the inner surface of the sheath 628 to facilitate flow between the openings 656 and the port 622. The sheath 628 can include retainers 658 (e.g., anchors, bands, rings) disposed on either side of the expandable device 630. The retainer 658 can couple the proximal and distal sides of the expandable device 630 to the sheath 628 and can prevent fluid and / or gas from escaping the expandable device 630 and / or prevent the expandable device 630 from sliding along the sheath 628. In some variations, the distal end of the tube 654 can be sealed inside the distal end of the sheath 628 to prevent fluid and / or gas from escaping the sheath 628. The tube 654 can include a lumen 660 through which the thermal assembly 602 (e.g., the tube 618, the distal end 646, and / or the heating element 632) can be advanced.

[0395] To expand expandable device 630 (e.g., a balloon), fluid and / or gas can be introduced through port 622. The fluid and / or gas can travel through gap 662 between tube 654 and sheath 628 through one or more openings 656 into expandable device 630 until it fills expandable device 630. To deflate expandable device 630, the fluid and / or gas can flow back through one or more openings 656 into gap 662 between tube 654 and sheath 628 and out port 622.

[0396] As shown in FIGS. 55A and 55B , the heat assembly 602 can be advanced distally through the tube 654. The heat assembly 602 can be advanced so that the distal end 646 having the heating element 632 is disposed distally outside the sheath 628. The exposed heating element 632 can be heated and advanced into contact with the thrombus and / or other occlusion. As shown in FIG. 55C , the heat assembly 602 (e.g., the tube 618, the distal end 646, and / or the heating element 632) can be advanced distally through the connector 620 (e.g., the port 623 and / or the valve 624) and inserted into the tube 654, which is disposed within the tube 654. The tube 654 can seal and / or clamp the tube 618.

[0397] In use, the guidewire 608 can be navigated through the vasculature to the thrombus. The heat assembly 602 (e.g., tubing 618) can be advanced through the anchoring assembly 603. For example, the heat assembly 602 (e.g., tubing 618) can be advanced distally through the connector 620 (e.g., valve 624, tubing 654) and the tubing 654 disposed inside the sheath 628, which can include being advanced distally inside the sheath 628 to within a distal portion of the sheath 628, as shown in FIG. 55A . The valve 624 can be used to clamp onto the tubing 618 to couple the heat assembly 602 and the anchoring assembly 603 together. The proximal end of the guidewire 608 can be positioned through the opening 648 in the distal end 646. The heat assembly 602 and anchoring assembly 603 can be advanced distally together over the guidewire 608 such that the guidewire 608 extends through a tube 638 within the tube 618 and out of the connector 604 (e.g., port 607, hub 610). An electrode 650 disposed at a distal end 646 of the tube 618 can aid in visually positioning the thermal thrombectomy system 600 within the vasculature as the heat assembly 602 and anchoring assembly 603 are advanced distally over the guidewire 608. In some variations, the anchoring assembly 603 can be advanced distally over the guidewire 608, followed by the heat assembly.

[0398] Once the distal portions of the heat assembly 602 and anchoring assembly 603 are positioned at and proximal to the thrombus and / or other occlusion, the expandable device 630 can be expanded. Fluid and / or gas can be introduced through port 622 to inflate the expandable device 630 as described herein. The expandable device 630 can expand to contact the surrounding vessel wall and anchor and / or center the anchoring assembly 603. The valve 624 can be unclamped from the tube 618 of the heat assembly 602. The heat assembly 602 can be advanced such that the heating element 632 is positioned distally from the tube 654 and / or sheath 628. The clinician can initiate heating of the heating element 632 using the handpiece 616 (e.g., by pressing button 634). The heating element 632 can be heated to a particular temperature, which can include at least any of those described herein. Temperature sensor 643 can sense the temperature of heating element 632, which can be used to automatically control the temperature of heating element 632 (eg, adjust the current and / or voltage).

[0399] The heating element 632 can be advanced to contact the thrombus. The heat from the heating element 632 can facilitate penetration of the thrombus, which can include softening and / or emulsifying the thrombus (e.g., softening and / or emulsifying the core of the thrombus). In some variations, the heating element 632 can penetrate and traverse the thrombus without assistance from the guidewire 608. In some variations, the heating element 632 and the guidewire 608 can cooperate to penetrate and / or traverse the thrombus. For example, the heating element 632 can be advanced to contact the thrombus and apply heat to soften and / or emulsify the thrombus, and then the guidewire 608 can be advanced to engage the thrombus.

[0400] Once the heating element 632 and guidewire 608 have crossed the thrombus (e.g., positioned distal to the thrombus), the thermal assembly 602 can be retracted from the vasculature through the lumen 660 of the tube 654 disposed inside the sheath 628. A capture device and / or cutting device can be advanced distally through the sheath 628 over the guidewire 608 (e.g., the tube 654 is disposed inside the sheath 628). The capture device can include at least any of those described herein and can be positioned distal to the thrombus. The capture device can be extended distal to the thrombus and retracted to capture and remove the thrombus, which can include removal through the lumen 660 of the tube 654 within the sheath 628. In some variations, a cutting device, which may include a heating element, can be introduced through the anchoring assembly 603 to fragment and remove the thrombus. The anchoring assembly 603 and / or guidewire 608 can be retracted proximally and removed.

[0401] The acts, steps, methods, etc. described herein may be performed by a clinician (e.g., a surgeon) and / or by a robot.

[0402] (term) Although the systems and methods are disclosed in the context of particular embodiments and examples, it will be understood by those skilled in the art that the systems and methods extend beyond the specifically disclosed embodiments to the use of other alternatives and / or embodiments, as well as certain modifications and equivalents thereof. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various modes of the systems and methods. The scope of the present disclosure should not be limited by the particular disclosed embodiments described herein.

[0403] Included are methods of using the aforementioned systems (including devices, apparatus, assemblies, structures, etc.), which may include using or assembling any one or more of the features disclosed herein to achieve the functions and / or characteristics of the systems as discussed in this disclosure. Included are methods of manufacturing the aforementioned systems, which may include providing, making, connecting, assembling, and / or installing any one or more of the features of the systems disclosed herein to achieve the functions and / or characteristics of the systems as discussed in this disclosure.

[0404] Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, while features may be described above as working in a particular combination, one or more features from a claimed combination can, in some cases, be excluded from that combination, and the combination can be claimed as any subcombination or a variation of any subcombination.

[0405] Furthermore, while operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown or in sequential order to achieve desired results, and not all operations need be performed. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Moreover, operations may be rearranged or reordered in other implementations. Also, the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged in multiple products. Moreover, other implementations are within the scope of this disclosure.

[0406] Conditional language such as "can," "possible," "could," or "may," unless expressly stated otherwise or interpreted otherwise within the context of use, is generally intended to convey that particular embodiments include or do not include particular features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that a feature, element, and / or step is in some way required in one or more embodiments.

[0407] Unless otherwise specified, conjunctive language such as "at least one of X, Y, and Z" is understood in the context in which it is generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0408] Several embodiments have been described in connection with the accompanying drawings. Components may be added, removed, and / or rearranged. For example, orientation references such as "top" and "bottom" are for ease of description and may be rearranged so that top features are proximate the bottom and bottom features are proximate the top. Furthermore, any particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. disclosed herein relating to various embodiments can be used in all other embodiments described herein. Furthermore, it will be recognized that any method described herein may be implemented using any device suitable for performing the recited steps.

[0409] In summary, various embodiments and examples of thermal thrombectomy devices, systems, and methods have been disclosed. While the systems and methods have been disclosed in the context of those embodiments and examples, it will be understood by those skilled in the art that the disclosure extends beyond the specifically disclosed embodiments to the use of other alternative and / or other embodiments, as well as certain modifications and equivalents thereof. The disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with or substituted for one another. The scope of the disclosure should not be limited by the particular disclosed embodiments described above, but should be determined solely by a fair reading of the following claims.

Claims

1. 1. A thermal device configured to apply heat to a thrombus, comprising: an outer tube having a distal portion; a heating element disposed in the distal portion of the outer tube; one or more conduits configured to apply an electric current to the heating element to increase the temperature of the heating element and apply heat to the thrombus; A thermal device comprising:

2. The thermal device of claim 1 , further comprising an inner tube disposed within the outer tube and configured to receive a guidewire, the thermal device being configured to be advanced over the guidewire.

3. The thermal device of claim 1 or 2, wherein the heating element comprises a loop.

4. The thermal device of claim 3 , wherein the loop comprises a nickel-titanium alloy.

5. The thermal device of claim 3 or 4, wherein the loop comprises a tube.

6. 113. The thermal device of claim 112, wherein the loop comprises a hollow lumen, the thermal device further comprising a temperature sensor disposed within the hollow lumen.

7. 114. The thermal device of claim 113, further comprising a controller configured to modulate the current applied to the heating element based on the temperature sensed by the temperature sensor.

8. The thermal device according to any one of claims 1 to 7, further comprising a temperature sensor.

9. The thermal device according to any one of claims 1 to 8, further comprising an electrode for sensing leakage current.

10. The thermal device of claim 9 , wherein the electrodes are markers for visualization.

11. The thermal device of any one of claims 1 to 10, further comprising an expandable device configured to be expanded proximal to the thrombus.

12. The thermal device of claim 11 , wherein the expandable device comprises a balloon.

13. 13. The thermal device of claim 11 or 12, wherein the expandable device comprises a lumen configured for the outer tube to be advanced through.

14. 1. A thermal thrombus removal device configured to apply heat to a thrombus, comprising: an expandable assembly comprising an expandable device, the expandable assembly configured to be expanded proximal to the thrombus; a thermal assembly comprising a heating element, the thermal assembly configured to be advanced distally over the guidewire and exit the expandable assembly, and to apply heat to the thrombus using the heating element; A thermal thrombus removal device comprising:

15. The thermal thrombus removal device of claim 14 , wherein the thermal assembly further comprises one or more conduits configured to apply an electrical current to the heating element to increase the temperature of the heating element.

16. The thermal thrombectomy device of claim 14 or 15, wherein the expandable device is a balloon.

17. The thermal thrombus removal device according to any one of claims 14 to 16, wherein the heating element comprises a loop.

18. The thermal thrombectomy device of claim 17 , wherein the loop comprises a tube.

19. 20. The thermal thrombus removal device of claim 18, wherein the loop comprises a hollow lumen, the thermal thrombus removal device further comprising a temperature sensor disposed within the hollow lumen.

20. 20. The thermal thrombus removal device of claim 19, further comprising a controller configured to modulate the current applied to the heating element based on the temperature sensed by the temperature sensor.

21. The thermal thrombectomy device according to any one of claims 14 to 18, further comprising a temperature sensor.

22. The thermal thrombectomy device according to any one of claims 14 to 21, further comprising an electrode for sensing leakage current.

23. 1. A method of crossing a thrombus, comprising: advancing a thermal assembly over the guidewire to the thrombus; applying an electric current to a heating element of the thermal assembly to heat the thrombus; A method comprising:

24. 24. The method of claim 23, further comprising the steps of advancing an expandable device over the guidewire adjacent to the thrombus and expanding the expandable device.

25. 25. The method of claim 24, wherein the expandable device comprises a balloon.

26. 1. A thermal thrombus removal device configured to apply heat to a thrombus in a blood vessel of a patient, comprising: A wire, an insulating layer disposed over at least a proximal portion of the wire to protect the patient's anatomy from heat; a temperature modulation unit configured to apply energy to the wire to increase the temperature of the wire; Equipped with The thermal thrombectomy device, wherein the wire is configured to be navigated through the patient's vasculature to apply heat to a thrombus.

27. 27. The device of claim 26, wherein the wire comprises a nickel and titanium alloy.

28. 28. The device of claim 26 or 27, wherein the insulating layer is a sheath.

29. The device of any one of claims 26 to 28, further comprising a power source.

30. 30. The device of claim 29, wherein the power source is a battery.

31. 27. The device of claim 26, wherein the wire is a guidewire.

32. A device according to any one of claims 26 to 31, wherein the energy applied by the temperature modulation unit is electricity.

33. 33. The device of any one of claims 26 to 32, wherein the temperature modulation unit is configured to increase the temperature of the wire to heat collagen of the thrombus to 60°C or higher.

34. 33. The device of any one of claims 26 to 32, wherein the temperature modulation unit is configured to increase the temperature of the wire to heat collagen of the thrombus to 80°C or higher.

35. A device according to any one of claims 26 to 32, wherein the temperature modulation unit is configured to raise the temperature of the wire to 60°C or above.

36. A device according to any one of claims 26 to 32, wherein the temperature modulation unit is configured to raise the temperature of the wire to 80°C or above.

37. A device according to any one of claims 26 to 36, wherein the wire comprises a coil.

38. 1. A thermal thrombectomy system configured to apply heat to a thrombus in a blood vessel of a patient, comprising: A wire, a layer of material surrounding a proximal portion of the wire; a power source configured to apply energy to the wire to increase the temperature of the wire; Equipped with The thermal thrombectomy system, wherein the wire is configured to be navigated through a patient's vasculature to apply heat to the thrombus.

39. 39. The system of claim 38, wherein the wire is a guidewire.

40. 40. The system of claim 38 or 39, wherein the layer of material is a sheath.

41. 41. The system of any one of claims 38 to 40, wherein the layer of material is configured to insulate the patient's anatomy from the heat of the wire.

42. 42. The system of any one of claims 38 to 41, wherein the wire comprises a nickel and titanium alloy.

43. The system of any one of claims 38 to 42, wherein the power source is a battery.

44. 44. The system of any one of claims 38 to 43, wherein the layer of material comprises polytetrafluoroethylene.

45. 45. The system of any one of claims 38 to 44, wherein the energy applied by the power source is electricity.

46. 46. ​​The system of any one of claims 38 to 45, wherein the power source is configured to increase the temperature of the wire to heat collagen of the thrombus to between 60 and 200°C.

47. 46. ​​The system of any one of claims 38 to 45, wherein the power source is configured to increase the temperature of the wire to heat collagen in the thrombus to 80°C or more.

48. 46. ​​A system according to any one of claims 38 to 45, wherein the power supply is configured to raise the temperature of the wire to between 60 and 200°C.

49. 46. ​​A system according to any one of claims 38 to 45, wherein the power supply is configured to raise the temperature of the wire to 80°C.

50. 46. ​​The system of any one of claims 38 to 45, wherein the wire comprises a coil disposed within the layer of material and configured to be deployed when adjacent to the thrombus.

51. 51. The system of claim 50, wherein the outer periphery of the coil is insulated.

52. 50. The system of any one of claims 28 to 49, wherein the wire comprises two coils stacked one on top of the other.

53. 50. The system of any one of claims 28 to 49, wherein the wire comprises a coil drill.

54. The system of any one of claims 28 to 49, wherein the wire comprises a lasso.

55. 50. The system of any one of claims 28 to 49, wherein the wire comprises a coil and a straight portion disposed through the coil.

56. 50. The system of any one of claims 28 to 49, wherein the wire comprises an outer coil and an inner coil joined together at a distal end, the inner coil being heated and the outer coil being unheated.

57. 50. The system of any one of claims 28 to 49, wherein the wire comprises an outer coil and an inner coil joined together at a distal end, the outer coil being insulated.

58. 1. A method of performing thrombectomy, comprising: navigating a wire through the patient's vasculature to the thrombus; applying an energy source to the wire to increase the temperature of the guidewire; advancing the wire through the thrombus; A method comprising:

59. 60. The method of claim 58, further comprising advancing an expandable member along the wire distal to the thrombus.

60. 60. The method of claim 58 or 59, further comprising advancing a cutting device along the wire and into the thrombus.

61. 61. The method of claim 60, further comprising rotating the cutting device.

62. 62. The method of claim 60 or 61, wherein the cutting device is an auger.

63. 63. The method of any one of claims 58 to 62, further comprising the step of aspirating the thrombus.

64. 1. A method of performing thrombectomy, comprising: navigating a wire within a sheath through the patient's vasculature to the thrombus; applying an energy source to the wire to increase the temperature of the wire; advancing the sheath and the wire into the thrombus; removing a distal portion of the wire from the sheath and allowing the wire to self-expand; retracting the wire; A method comprising:

65. 65. The method of claim 64, wherein the wire self-expands into a coil, further comprising rotating the coil.

66. 66. The method of claim 64 or 65, further comprising the step of aspirating the thrombus.

67. 1. A method of performing thrombectomy, comprising: navigating a wire within a sheath through the patient's vasculature to the thrombus; applying an energy source to the wire to increase the temperature of the wire; removing a distal portion of the wire from the sheath and allowing the wire to self-expand; advancing the wire into the thrombus; retracting the wire; A method comprising:

68. 68. The method of claim 67, wherein the wire self-expands into a coil, further comprising rotating the coil.

69. 69. The method of any one of claims 67 and 68, further comprising the step of aspirating the thrombus.

70. 1. A thermal thrombectomy device comprising: a catheter having a port and a mount; a wire extending through the port, the wire including an inner portion inside the catheter and an outer portion forming a lasso disposed outside the catheter, the end of the outer portion being coupled to the mount; and a power source configured to apply an electric current to electrical contacts disposed on the port and mount to increase the temperature of the wire and soften or emulsify collagen within the thrombus; a cable extending through the catheter, the inner portion of the wire being coupled to the cable; and Equipped with The cable is configured to be rotated to extend the wire further outside the catheter and increase the diameter of the lasso.

71. 1. A thermal thrombectomy system configured to remove a thrombus from a blood vessel of a patient, comprising: A system comprising a capture device comprising a bag and a loop at an opening to the bag configured to apply heat to a thrombus to heat it, the capture device being configured to retract proximally to bring the loop into interfacial contact with the thrombus to detach the thrombus from a wall of a blood vessel, and the bag being configured to capture the detached thrombus.

72. 72. The system of claim 71, further comprising a catheter, wherein the capture device is configured to be deployed distally to the thrombus through the catheter.

73. 73. The system of claim 71 or 72, further comprising a heating wire configured to penetrate the thrombus and facilitate distal positioning of the capture device relative to the thrombus.

74. 74. The system of any one of claims 71 to 73, wherein the distal end of the capture device comprises a heating element configured to penetrate the thrombus and facilitate distal positioning of the capture device relative to the thrombus.

75. 75. The system of any one of claims 71 to 74, further comprising an expandable device having a balloon configured to expand proximal to the thrombus.

76. 75. The system of any one of claims 71 to 74, wherein the temperature is 80°C or higher.

77. 75. The system of any one of claims 71 to 74, wherein the temperature is between 60°C and 80°C.

78. 75. The system of any one of claims 71 to 74, wherein the temperature is between 60°C and 70°C.

79. The system of any one of claims 71 to 78, further comprising a sheath configured to be positioned over the capture device.

80. 80. The system of any one of claims 71 to 79, wherein the loop has a diameter greater than the diameter of the blood vessel.

81. The system of any one of claims 71 to 80, further comprising a suction device configured to aspirate the thrombus.

82. 82. The system of claim 81, wherein the suction device comprises a mouthpiece configured to be heated.

83. 83. The system of any one of claims 71 to 82, further comprising a temperature sensor configured to sense a temperature within the blood vessel.

84. The system of any one of claims 71 to 83, wherein the system is configured to control the temperature of the loop based on the sensed temperature within the blood vessel.

85. 1. A method of performing thrombectomy, comprising: placing a capture device distal to the thrombus within the blood vessel; expanding a bag of the capture device; heating a loop located in the bag at a proximal opening to a specific temperature; retracting the capture device proximally to bring the loop into interfacial contact with the thrombus and detach the thrombus from the wall of the vessel; capturing the thrombus within the bag; proximally retracting the capture device with the thrombus within the bag to remove the thrombus from the patient; A method comprising:

86. 86. The method of claim 85, further comprising penetrating the thrombus with a heated wire.

87. 87. The method of claim 85 or 86, wherein the temperature is between 60°C and 200°C.

88. 87. The method of claim 85 or 86, wherein the temperature is 80°C or higher.

89. 87. The method of claim 85 or 86, wherein the temperature is between 60°C and 80°C.

90. 87. The method of claim 85 or 86, wherein the temperature is between 60°C and 70°C.

91. 91. The method of any one of claims 85 to 90, further comprising the step of aspirating the thrombus with a suction device.

92. 92. The method of claim 91, further comprising the step of heating the mouth of the suction device.

93. 93. The method of any one of claims 85 to 92, further comprising sensing a temperature within the blood vessel and controlling the temperature of the loop based on the sensed temperature.

94. 1. A thermal thrombectomy system configured to remove a thrombus from a blood vessel of a patient, comprising:

1. A system comprising: an aspiration device having a mouth configured to be heated to a temperature that softens or emulsifies the thrombus, the aspiration device configured to advance distally into interfacial contact with the thrombus and aspirate the thrombus.

95. 95. The system of claim 94, wherein the temperature is between 60°C and 200°C.

96. 95. The system of claim 94, wherein the temperature is 80°C or higher.

97. 95. The system of claim 94, wherein the temperature is between 60°C and 80°C.

98. 95. The system of claim 94, wherein the temperature is between 60°C and 70°C.

99. 1. A thermal thrombectomy system configured to remove a thrombus from a blood vessel of a patient, comprising: a capture device comprising a bag; a cutting device comprising a loop configured to be heated to a temperature that softens or emulsifies a thrombus in a blood vessel; Equipped with The system is configured such that the capture device and the cutting device are positioned distal to the thrombus and retracted proximally to bring the loop into interfacial contact with the thrombus, detach the thrombus from the wall of the blood vessel, and capture the detached thrombus within the bag.

100. 100. The system of claim 99, further comprising a catheter, wherein the capturing device and the cutting device are configured to be deployed distally to the thrombus through the catheter.

101. 101. The system of claim 99 or 100, further comprising a heating wire configured to penetrate the thrombus and facilitate distal positioning of the capture device relative to the thrombus.

102. 102. The system of any one of claims 99 to 101, wherein the distal end of the capture device or the distal end of the cutting device comprises a heating element configured to penetrate the thrombus and facilitate distal positioning of the capture device and the cutting device relative to the thrombus.

103. 103. The system of any one of claims 99 to 102, wherein the bag comprises a mesh.

104. The system of any one of claims 99 to 103, wherein the temperature is 80°C or higher.

105. 104. The system of any one of claims 99 to 103, wherein the temperature is between 60°C and 80°C.

106. 104. The system of any one of claims 99 to 103, wherein the temperature is between 60°C and 70°C.

107. The system of any one of claims 99 to 106, further comprising a sheath configured to be positioned over the capture device.

108. 108. The system of any one of claims 99 to 107, further comprising a temperature sensor configured to sense a temperature within the blood vessel, the system configured to control the temperature of the loop based on the sensed temperature within the blood vessel.

109. A system according to any one of claims 99 to 108, wherein the capturing device and the cutting device are coupled together.

110. 110. The system of any one of claims 99 to 109, wherein an extension boom extends from a proximal opening into the bag to a distal end of the bag.

111. 1. A method of performing thrombectomy, comprising: positioning a capture device and a cutting device distal to the thrombus within the blood vessel; expanding a bag of the capture device; heating the loop of the cutting device to a specific temperature; retracting the cutting device proximally to bring the loop into interfacial contact with the thrombus and detach the thrombus from the wall of the vessel; capturing the thrombus within the bag; proximally retracting the cutting device and the capturing device with the thrombus in the bag to remove the thrombus from the patient; A method comprising:

112. 112. The method of claim 111, further comprising the step of penetrating the thrombus with a heated wire.

113. 113. The method of claim 111 or 112, wherein the temperature is between 60°C and 200°C.

114. 113. The method of claim 111 or 112, wherein the temperature is 80°C or higher.

115. 113. The method of claim 111 or 112, wherein the temperature is between 60°C and 80°C.

116. 113. The method of claim 11 or 112, wherein the temperature is between 60°C and 70°C.

117. The method of any one of claims 111 to 116, further comprising the step of aspirating the thrombus with a suction device.

118. 118. The method of claim 117, further comprising the step of heating the mouth of the suction device.

119. 119. The method of any one of claims 111 to 118, further comprising sensing a temperature within the blood vessel and controlling the temperature of the loop based on the sensed temperature.

120. 1. A thrombus removal system comprising: a recessed surface configured to deploy to engage the thrombus; a conduit configured to provide energy to the recessed surface to heat the recessed surface to a particular temperature and soften or emulsify the thrombus; A system comprising:

121. 1. A thermal thrombectomy system comprising: The components and a temperature modulation unit configured to apply energy to the member to heat the member to a particular temperature; Equipped with The member is configured to be navigated through a blood vessel to apply heat to a thrombus.

122. 122. The system of claim 121, wherein the member comprises a wire.

123. 123. The system of claim 121 or 122, wherein the energy is an electric current.

124. 124. The system of any one of claims 121 to 123, wherein the temperature is between 60°C and 200°C.

125. 1. A thermal thrombectomy system comprising: an expandable device comprising one or more heating elements; a temperature modulation unit configured to apply energy to the one or more heating elements to heat the one or more elements to a particular temperature; Equipped with The expandable device is configured to be retracted proximally to apply heat to the thrombus with the one or more heating elements.

126. 126. The system of claim 125, wherein the expandable device comprises an expandable bag configured to capture the thrombus.

127. 127. The system of claim 125 or 126, wherein the energy is an electric current.

128. The system of any one of claims 125 to 127, wherein the temperature is 60°C or higher.

129. 1. A method of performing thrombectomy, comprising: expanding the expandable device distal to the thrombus; applying energy to one or more heating elements of the expandable device to heat the one or more elements to a particular temperature; retracting the expandable device to bring the one or more heating elements into interfacial contact with the thrombus; capturing the thrombus within the expandable device; A method comprising:

130. 130. The method of claim 129, wherein the expandable device comprises an expandable bag configured to capture the thrombus.

131. 131. The method of claim 129 or 130, wherein the energy is an electric current.

132. 132. The method of any one of claims 129 to 131, wherein the temperature is 60°C or higher.

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