THERMAL THROMBECTOMY AND ATHERECTOMY SYSTEMS AND METHODS

This disclosure relates to thermal thrombectomy and atherectomy systems and methods for removing an occlusion, such as a thrombus and/or plaque from a blood vessel. The systems can include a distal balloon and a proximal balloon. The distal balloon can be positioned distal of the occlusion, and the proximal balloon can be positioned proximal of the occlusion. The system can include an irrigation catheter that directs heated fluid to the occlusion between the distal and proximal balloons. The heated fluid can soften and/or emulsify the occlusion. The system can include an aspiration catheter that can aspirate the softened and/or emulsified occlusion from the blood vessel.

FIELD

This disclosure relates to thrombectomy and atherectomy systems and methods.

BACKGROUND

The vascular system carries blood throughout the body. The vascular system includes arteries that distribute blood containing oxygen from the heart throughout the body and veins that carry deoxygenated blood back to the heart.

Thrombosis occurs when a thrombus (e.g., blood clot) forms within a blood vessel, whether venous or arterial. The thrombus may restrict blood flow through the blood vessel. For example, deep vein thrombosis (DVT) occurs when the thrombus forms in a deep vein, restricting blood flow back toward the heart. DVT typically develops in the lower leg, thigh, or pelvis but may also occur in other locations of the body, such as the arm. DVT can result in swelling, pain, discoloration, scaling, and/or ulcers. Additionally, a fragment (e.g., embolus) of the thrombus may break off and travel through the blood stream to the lungs, resulting in a pulmonary embolism (PE)-a potentially fatal condition.

Atherosclerosis is a chronic and progressive disease characterized by the accumulation of plaque within arterial walls. This accumulation can lead to narrowing and/or hardening of the arteries and/or restricting blood flow which can cause cardiovascular diseases, such as peripheral artery disease, coronary artery disease, and/or carotid artery disease that can lead to life-threatening complications such as heart attacks and/or strokes.

SUMMARY

Thrombi can be removed by way of a thrombectomy procedure. A thrombectomy procedure may include navigating a guidewire with the assistance of an imaging system (e.g., fluoroscopic x-ray imaging) through the vascular system to pass through the thrombus to a distal location. A catheter can be advanced along the guidewire and through the thrombus to deploy (e.g., expand) an expandable bag distal of the thrombus. The expandable bag can be retracted proximally, scraping the inner walls of the vessel, to capture the thrombus and deposit it into the catheter for removal. The surgeon performing the thrombectomy may perform multiple passes with the expandable bag to remove the thrombus. Performing multiple passes can be time consuming and frustrating. Additionally, the likelihood of incurring damage to the vessel walls and/or valves increases with each pass. Multiple passes can increase the risk of vessel inflammation and re-thrombosis.

A thrombus can include fibrin, red blood cells, platelets, leukocytes, and neutrophil extracellular traps, and as time passes, the thrombus accumulates more collagen and fibrin content. As more collagen is accumulated, the thrombus becomes harder, and it can be difficult for guidewires, catheters, and/or expandable devices to pass through the thrombus. Additionally, it can be difficult to detach the thrombus from the vessel wall with expandable devices and/or cutting devices for removal. Accordingly, attempting to remove a thrombus, such as a hardened thrombus, can be time consuming, frustrating, and/or result in damage to the vessel wall and/or valves. Accordingly, thrombectomy solutions to ease the removal of a thrombus with less damage to vessel walls are needed.

Atherosclerosis can be addressed with an atherectomy procedure. For example, an angioplasty procedure with stenting can be performed to widen and maintain a narrowed or blocked artery. In another example, bypass surgery (e.g., coronary artery bypass grafting, peripheral artery bypass) can be performed to create a new pathway for blood flow around a blocked artery. In another example, an endarterectomy procedure (e.g., carotid endarterectomy, femoral endarterectomy) can be performed to remove plaque from the inner lining of an artery wall. However, current atherectomy procedures can be invasive, damage arterial walls, fail to remove plaque, and/or be susceptible to significant complications.

The thermal systems and methods (e.g., thermal thrombectomy and/or atherectomy systems and methods) disclosed herein may at least address the problems indicated above. The thermal systems and methods described herein may use a heated fluid to soften and/or emulsify thrombi, plaque, and/or other occlusions for aspiration, which can be advantageous over current systems and methods for thrombectomy and/or atherectomy procedures. Thrombus (e.g., acute and/or chronic), which can be made of one or more proteins and/or biopolymers, and/or plaque, which can be made of lipids, cholesterol, calcium, and/or other substances, can be softened and/or emulsified (e.g., melted, liquefied) when exposed to heat. Accordingly, when the thrombus and/or plaque is exposed to heat, the thrombus and/or plaque can soften and/or emulsify to ease penetration, detachment from vessel walls (e.g., venous or arterial), and/or aspiration, which can ease removal of the thrombus and/or plaque.

For example, the thermal systems and methods described herein can be less invasive and utilize a catheter-based approach, which may avoid open surgery and/or reduce the risk of complications. The thermal systems and methods described herein can remove more of (e.g., completely remove) a thrombus, plaque, and/or other occlusion, which can reduce repeat procedures. The thermal systems and methods can reduce damage to blood vessel walls (e.g., vein and/or arterial) in removing a thrombus, plaque and/or other occlusion, which can promote healing and reduce the risk of new thrombi and/or plaque developing. For example, the thermal systems and methods disclosed herein may obviate scraping vessel walls or reduce scraping passes to remove thrombi and/or plaque, which can decrease damage to vessel walls to improve patient outcome (e.g., reduce risk of new thrombi and/or plaque forming, complications, etc.). The thermal systems and methods disclosed herein may avoid or at least reduce the use of systemic medicaments. The thermal systems and methods disclosed herein may facilitate local removal of thrombi and/or plaque, which may preserve endothelial cells and valves. The thermal systems and methods can use a heated fluid with one or more medicaments, such as one or more bioactive agents, that can promote healing and/or reduce the risk of (e.g., prevent) new thrombi and/or plaque developing. The thermal systems and methods disclosed herein may access all anatomical blood vessel locations (e.g., below knee and smaller vessels). The thermal systems and methods disclosed herein may reduce blood loss. The thermal systems disclosed herein may be disposable (e.g., no console) or reusable.

The thermal systems and methods disclosed herein can include a first balloon and a second balloon. The first balloon can be positioned distal of an occlusion (e.g., thrombus and/or plaque) in a blood vessel. The second balloon can be positioned proximal of the occlusion. The first balloon and the second balloon can be expanded, which can isolate the segment of the blood vessel with the occlusion from the remainder of the blood vessel. The thermal systems and methods can include an irrigation device (e.g., irrigation catheter) with an irrigation aperture that can be positioned between the first balloon and the second balloon. The irrigation device can deliver a heated fluid to the occlusion to soften and/or emulsify the occlusion. The expanded first and the second balloons can impede the heated fluid and/or softened and/or emulsified occlusion from flowing beyond the first and second balloons. The thermal systems and methods can include an aspiration device (e.g., aspiration catheter) with an aspiration aperture that can be positioned between the first balloon and the second balloon. The aspiration device can aspirate the softened and/or emulsified occlusion and/or heated fluid from the blood vessel for removal. In some variants, the irrigation device and aspiration device can be combined into a single device, which can include a single device with two ports and/or openings. The flow rate, pressure, velocity, flux, irrigation opening size, and/or temperature of the heated fluid can be adjusted based on sensed conditions (e.g., sensed conditions at the occlusion site and/or in the thermal system). For example, the thermal systems and methods can include a temperature sensor that can sense a temperature at the occlusion site, which can be at the delivery of the heated fluid. Based on the sensed temperature, the thermal systems and methods can adjust the temperature of the heated fluid. The flow rate, pressure, velocity, aspiration opening size, and/or flux for aspiration can be adjusted based on sensed conditions (e.g., sensed conditions at the occlusion site and/or in the thermal system). Irrigation and aspiration can be performed simultaneously or separately (e.g., one after the other).

In some aspects, the techniques described herein relate to a thermal system for removing an occlusion from a blood vessel, the system including: an irrigation catheter including one or more apertures at a distal portion; wherein the irrigation catheter is configured to be navigated through a blood vessel to deliver a heated fluid to an occlusion to soften and/or emulsify the occlusion. The irrigation catheter can be a cannula, tube, etc.

In some aspects, the techniques described herein relate to a system, further including an aspiration catheter configured to aspirate the softened and/or emulsified occlusion.

In some aspects, the techniques described herein relate to a system, wherein the irrigation catheter and aspiration catheter are concentrically positioned.

In some aspects, the techniques described herein relate to a system, wherein the aspiration catheter is configured to include an internal pressure that aspirates in the heated fluid delivered by the irrigation catheter.

In some aspects, the techniques described herein relate to a system and 4, wherein the irrigation catheter is inside the aspiration catheter.

In some aspects, the techniques described herein relate to a system and 4, wherein the aspiration catheter is inside the irrigation catheter.

In some aspects, the techniques described herein relate to a system, wherein the one or more apertures of the irrigation catheter are disposed through a peripheral wall of the irrigation catheter.

In some aspects, the techniques described herein relate to a system, wherein the irrigation catheter includes one or more heated elements to heat the heated fluid.

In some aspects, the techniques described herein relate to a system, wherein the heated elements are disposed on the distal portion of the irrigation catheter.

In some aspects, the techniques described herein relate to a system, wherein the heated elements are disposed at the one or more apertures of the irrigation catheter.

In some aspects, the techniques described herein relate to a system, further including a fluid reservoir configured to hold the heated fluid prior to delivery.

In some aspects, the techniques described herein relate to a system, further including a reservoir heating element configured to heat the heated fluid held in the fluid reservoir.

In some aspects, the techniques described herein relate to a system, further including a crossing element configured to be heated to facilitate penetrating the occlusion.

In some aspects, the techniques described herein relate to a system, further including a distal balloon catheter including a distal balloon configured to be inflated distal of the occlusion.

In some aspects, the techniques described herein relate to a system, wherein the distal balloon catheter is configured to be advanced through the irrigation catheter to position the distal balloon distal of the irrigation catheter.

In some aspects, the techniques described herein relate to a system, further including a proximal balloon configured to be inflated proximal of the occlusion.

In some aspects, the techniques described herein relate to a system, wherein the proximal balloon is disposed on an aspiration catheter.

In some aspects, the techniques described herein relate to a system, wherein the aspiration catheter includes a working lumen through which the distal balloon catheter is configured to be advanced.

In some aspects, the techniques described herein relate to a system, wherein the irrigation catheter is configured to be advanced through the working lumen.

In some aspects, the techniques described herein relate to a system, wherein the crossing element is configured to be advanced through and distal of the distal balloon catheter.

In some aspects, the techniques described herein relate to a system, further including syringes to inflate and deflate the proximal balloon and the distal balloon.

In some aspects, the techniques described herein relate to a system, wherein the irrigation catheter further includes a distal balloon and a proximal balloon, the distal balloon configured to be inflated distal of the occlusion and the proximal balloon configured to be inflated proximal of the occlusion.

In some aspects, the techniques described herein relate to a system, wherein the irrigation catheter includes one or more aspiration apertures configured to aspirate the softened and/or emulsified occlusion.

In some aspects, the techniques described herein relate to a system, further including a temperature sensor configured to sense a temperature of the heated fluid.

In some aspects, the techniques described herein relate to a system, wherein the system is configured to adjust the temperature of the heated fluid based on the sensed temperature.

In some aspects, the techniques described herein relate to a system, wherein the occlusion includes a thrombus.

In some aspects, the techniques described herein relate to a system, wherein the occlusion includes plaque.

In some aspects, the techniques described herein relate to a system, wherein

the heated fluid is at 60-120 degrees Celsius.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes a saline solution.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes a thrombolytic agent.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes urokinase.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes an anti-inflammatory.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes an anti-restenosis drug.

In some aspects, the techniques described herein relate to a method of softening and/or emulsifying an occlusion for removal, the method including: positioning one or more apertures of an irrigation catheter at an occlusion in a blood vessel; and delivering heated fluid through the one or more apertures of the irrigation catheter to the occlusion to soften and/or emulsify the occlusion.

In some aspects, the techniques described herein relate to a method, further including aspirating the softened and/or emulsified occlusion.

In some aspects, the techniques described herein relate to a method and 35, further including inflating a proximal balloon proximal of the occlusion.

In some aspects, the techniques described herein relate to a method, further including inflating a distal balloon distal of the occlusion.

In some aspects, the techniques described herein relate to a method, further including heating the heated fluid to 60-120 degrees Celsius.

In some aspects, the techniques described herein relate to a method, further including penetrating the occlusion with a heated element to facilitate crossover.

In some aspects, the techniques described herein relate to a method, further including sensing a temperature of the heated fluid and adjusting the temperature of the heated fluid based on the sensed temperature.

In some aspects, the techniques described herein relate to a method, further including adjusting a parameter of the heated fluid based on characteristics of the occlusion.

In some aspects, the techniques described herein relate to a method, wherein the occlusion includes a thrombus.

In some aspects, the techniques described herein relate to a method, wherein the occlusion includes plaque.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes a saline solution.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes a thrombolytic agent.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes urokinase.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes an anti-inflammatory.

In some aspects, the techniques described herein relate to a method, wherein heated the fluid includes an anti-restenosis drug.

In some aspects, the techniques described herein relate to a thermal system for removing an occlusion from a blood vessel, the system including: a multi-lumen tube including a proximal balloon and an aspiration lumen, the proximal balloon configured to be inflated proximally of an occlusion; an irrigation catheter configured to be advanced through and distally out of the multi-lumen tube to the occlusion; and a distal-balloon catheter including a distal balloon configured to be inflated distally of the occlusion, the distal-balloon catheter configured to be advanced through and distally out of the multi-lumen tube; wherein the irrigation catheter is configured to deliver heated fluid to the occlusion to soften and/or emulsify the occlusion; and wherein the aspiration lumen is configured to aspirate the softened and/or emulsified occlusion.

In some aspects, the techniques described herein relate to a thermal system, wherein the distal-balloon catheter is advanced through the irrigation catheter in the aspiration lumen.

In some aspects, the techniques described herein relate to a thermal system, wherein the irrigation catheter includes one or more apertures at a distal portion thereof.

In some aspects, the techniques described herein relate to a thermal system, wherein the one or more apertures extend through a peripheral wall of the irrigation catheter.

In some aspects, the techniques described herein relate to a thermal system, further including a heated element configured to penetrate the occlusion for crossover.

In some aspects, the techniques described herein relate to a thermal system, wherein the heated element is configured to be advanced through and distally out of the distal-balloon catheter.

In some aspects, the techniques described herein relate to a thermal system, further including syringes to inflate the proximal balloon and distal balloon.

In some aspects, the techniques described herein relate to a thermal system, further including a fluid reservoir configured to hold the heated fluid prior to delivery.

In some aspects, the techniques described herein relate to a system, further including a reservoir heating element configured to heat the heated fluid held in the fluid reservoir.

In some aspects, the techniques described herein relate to a system, further including a temperature sensor configured to sense a temperature of the heated fluid.

In some aspects, the techniques described herein relate to a system, wherein the system is configured to adjust the temperature of the heated fluid based on the sensed temperature.

In some aspects, the techniques described herein relate to a system, wherein the occlusion includes a thrombus.

In some aspects, the techniques described herein relate to a system, wherein the occlusion includes plaque.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid is at 60-120 degrees Celsius.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes a saline solution.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes a thrombolytic agent.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes urokinase.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes an anti-inflammatory.

In some aspects, the techniques described herein relate to a system, wherein the heated fluid includes an anti-restenosis drug.

In some aspects, the techniques described herein relate to a system, wherein the irrigation catheter includes a heated element.

In some aspects, the techniques described herein relate to a method of softening and/or emulsifying an occlusion for removal, the method including: proximally positioning a multi-lumen tube relative to an occlusion; inflating a proximal balloon of the multi-lumen tube; advancing a distal-balloon catheter through the multi-lumen tube to position a distal balloon distal of the occlusion; inflating the distal balloon; advancing an irrigation catheter through the multi-lumen tube to the occlusion; delivering heated fluid by way of the irrigation catheter to the occlusion to soften and/or emulsify the occlusion; and aspirating the softened and/or emulsified occlusion.

In some aspects, the techniques described herein relate to a method, wherein aspirating the softened and/or emulsified occlusion is by way of an aspiration lumen of the multi-lumen tube.

In some aspects, the techniques described herein relate to a method, wherein the distal-balloon catheter is advanced through the irrigation catheter.

In some aspects, the techniques described herein relate to a method, wherein the irrigation catheter is advanced through the aspiration lumen.

In some aspects, the techniques described herein relate to a method, further including penetrating the occlusion with a heated element to facilitate crossover.

In some aspects, the techniques described herein relate to a method, further including heating the heated fluid to 60-120 degrees Celsius.

In some aspects, the techniques described herein relate to a method, further including sensing a temperature of the heated fluid and adjusting the temperature of the heated fluid based on the sensed temperature.

In some aspects, the techniques described herein relate to a method, further including adjusting a parameter of the heated fluid based on characteristics of the occlusion.

In some aspects, the techniques described herein relate to a method, wherein the occlusion includes a thrombus.

In some aspects, the techniques described herein relate to a method, wherein the occlusion includes plaque.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes a saline solution.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes a thrombolytic agent.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes urokinase.

In some aspects, the techniques described herein relate to a method, wherein the heated fluid includes an anti-inflammatory.

In some aspects, the techniques described herein relate to a method, wherein heated the fluid includes an anti-restenosis drug.

In some aspects, the techniques described herein relate to a thermal system for removing an occlusion from a blood vessel, the system including: a catheter configured to deliver a heated fluid to an occlusion to soften and/or emulsify the occlusion.

In some aspects, the techniques described herein relate to a system, wherein the catheter includes a balloon that is configured to be inflated to impede flow through the blood vessel.

In some aspects, the techniques described herein relate to a system, further including a reservoir configured to hold the heated fluid.

In some aspects, the techniques described herein relate to a system, further including a reservoir heating element configured to heat the heated fluid held in the reservoir.

In some aspects, the techniques described herein relate to a system, wherein the catheter includes an opening configured to face in a proximal direction.

In some aspects, the techniques described herein relate to a system, further including an aspiration catheter configured to aspirate the softened and/or emulsified occlusion.

In some aspects, the techniques described herein relate to a system, wherein the opening of the catheter faces toward an aspiration opening of the aspiration catheter.

Neither the preceding summary nor the following detailed description purports to limit or define the scope of protection. The scope of protection is defined by the claims. Furthermore, reference is made herein to removing thrombi from veins and/or plaque from blood vessels, such as arteries. One of ordinary skill in the art will understand, after reviewing the entirety of this disclosure, that the systems and methods described herein may be applied to removing other occlusions from blood vessels of the body.

DETAILED DESCRIPTION

Although certain embodiments and examples are described below, this disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of this disclosure should not be limited by any particular embodiments described below. Furthermore, this disclosure describes many embodiments in reference to veins and arteries; the systems and methods described in relation to veins can be applied to arteries and those described in relation to arteries can be applied to veins.

FIG.1Aillustrates a limb100(e.g., leg, arm) of a person. The limb100includes a venous system102that carries deoxygenated blood from the limb100back to the heart.

FIG.1Billustrates a cross-section of a portion of a vein104of the venous system102with normal blood flow. The vein104includes a flow path106for the deoxygenated blood bounded by the wall118of the vein104. A thrombus108may develop within a vein104, as illustrated inFIG.1C, to partially restrict (e.g., impede, occlude, etc.) blood flow through the106. The thrombus108may form on the wall118of the vein104, which may include a valve. The wall118may from along the wall118for a variety of reasons, which may include damage to the wall118, inactivity, diet, and/or other reasons. The thrombus108may grow in size to completely block (e.g., impede, occlude, etc.) blood flow through the flow path106, as shown inFIG.1D. The occlusion of the blood flow can result in swelling, pain, and/or discoloration of the limb100. The removal of thrombi can relieve a patient of the foregoing symptoms as well as prevent or at least slow further symptoms from developing.

FIG.2Aillustrates a limb100(e.g., leg, arm) of a person. The limb100includes venous system102that carries deoxygenated blood from the limb100back to the heart.

FIG.2Billustrates a cross-section of a portion of a vein104of the venous system102with normal blood flow. The vein104includes a flow path106for the deoxygenated blood bounded by the wall118of the vein104. The vein104may include valves110. The valves110may open to allow blood to flow toward the heart and close to prevent backflow. Pockets112can be disposed downstream of the valves110between the valves110and the wall118of the vein104. As shown, a portion of blood in the flow path106may flow into the pockets112. A thrombus may begin to develop on the wall118of the vein104, valves110, and/or in the pockets112, as shown inFIG.2C, until a thrombus108is formed, as illustrated inFIG.2D. The thrombus108may fill the flow path106, which can include extending around the valves110and into the pockets112. The thrombus108may prevent proper function of the valves110. The thrombus108may partially or completely block blood flow through the vein104. In some instances, an embolus114may break off from the thrombus108, as illustrated inFIG.2E. The embolus114may travel to other regions of the body, which can include traveling to the lungs and result in a pulmonary embolism (PE)-a potentially lethal condition. Accordingly, the removal of thrombi may help a patient avoid a lethal condition.

FIG.3Aillustrates a limb100(e.g., leg, arm) of a person. The limb100includes a venous system102with multiple veins104. As shown inFIG.3B, a thrombus108may form in the vein104to block blood flow. The blocked blood flow may prevent drainage of blood from the limb100and cause swelling of the limb100below the thrombus108as indicated by portion116. As detailed herein, an embolus114may separate from the thrombus108and travel to other regions of the body, which can include traveling to the lungs and result in a pulmonary embolism (PE).

As a thrombus ages, the characteristics of the proximate portion of the vein and the thrombus itself may change, as indicated in the table shown inFIG.4.

For example, initially after formation (e.g., two days post thrombus initiation), a thrombus may be referred to as an acute thrombus. The vein wall proximate the acute thrombus may be thin and have a low collagen content. The main cells found in the vein wall proximate the acute thrombus may be neutrophils. The acute thrombus itself may have no or relatively little collagen. The main cells found in the acute thrombus may be neutrophils. The acute thrombus may be readily detached from the vein wall and/or penetrated.

After some additional time (e.g., six days post thrombus initiation), a thrombus may be referred to as a sub-acute/chronic thrombus. The vein wall proximate the sub-acute/chronic thrombus may be thickened and have a higher collagen content compared to the acute thrombus period. The main cells found in the vein wall proximate the sub-acute/chronic thrombus may be neutrophils and monocytes with the quantity of monocytes significantly increased compared to the acute thrombus period. The sub-acute/chronic thrombus itself may have an increased collagen content compared to the acute thrombus. The main cells found in the sub-acute/chronic thrombus may be neutrophils and monocytes. The sub-acute/chronic thrombus may be more difficult to detach from the vein wall compared to the acute thrombus and/or more difficult to penetrate. The sub-acute/chronic thrombus may have a lower weight compared to the acute thrombus.

After some additional time (e.g., fourteen days post thrombus initiation), a thrombus may be referred to as a chronic thrombus. The vein wall proximate the chronic thrombus may be thickened and have a higher collagen content compared to the sub-acute/chronic thrombus period. The main cells found in the vein wall proximate the chronic thrombus may be monocytes. The chronic thrombus may have an increased collagen content compared to the sub-acute/chronic thrombus. The main cells found in the chronic thrombus may be monocytes. The chronic thrombus may be more difficult to detach from the vein wall compared to the sub-acute/chronic thrombus and/or more difficult to penetrate. The chronic thrombus may have a lower weight compared to the sub-acute/chronic thrombus.

The hardness of a thrombus may increase over time, which may be due to the increase in collagen content. For example, a chronic thrombus may be harder than a sub-acute/chronic thrombus which may be harder than an acute thrombus. A harder thrombus may be more difficult to penetrate, which can make removal more difficult. Additionally, as indicated above, a chronic thrombus may be harder to detach from the vein wall compared to the sub-acute/chronic thrombus which may be harder to detach from the vein wall compared to the acute thrombus.

As shown inFIG.5A, an acute thrombus may be accompanied by inflammation of the proximate vein wall as well as stretching of the proximate vein wall. The acute thrombus may also damage the endothelial cells along the vein wall. The patient may experience pain and swelling in the region of the body with the acute thrombus. The acute thrombus may progress into a chronic thrombus over time. The chronic thrombus may be accompanied by venous hypertension, thickening of the vein wall, and matrix changes within the vein wall. The patient may at least experience swelling and pigmentation in the region of the body with the chronic thrombus.

FIG.6illustrates another example section of a vein104with a thrombus108. The thrombus108is disposed against the wall118and valve110of the vein104. The thrombus108is disposed in the pockets112. As illustrated, the thrombus108may result in hypoxia in the pockets112and surrounding tissue. During a thrombectomy procedure, the thrombus108is penetrated, but as explained, the thrombus108may become harder overtime making penetration more difficult. Additionally, the thrombus108may be increasingly harder to detach from the wall118and/or valves110as time passes. Accordingly, at least due to the foregoing reasons, a surgeon may need to perform multiple passes with a thrombectomy device to remove the thrombus. With each pass, the wall118may be scrapped in an effort to remove the thrombus. The likelihood of damaging the wall118and/or valves110of the vein104increases with the number of passes. The thermal thrombectomy systems and methods disclosed herein may reduce the number of passes, which may include reducing to a single pass, to remove a thrombus, decreasing the likelihood of damage to the wall118and/or valves110which may decrease the risk of re-thrombosis. The thermal thrombectomy systems and methods disclosed herein may reduce the overall ease and/or time of a procedure, which may lower the risk of complications and improve efficiency.

FIG.7Aillustrates an example section of an artery200. As shown, the artery200includes a flow path202through which red blood cells203can travel. The artery200can include a wall204, which can be smooth, surrounding the flow path202.FIG.7Billustrates the example section of the artery200with plaque206. Plaque206can accumulate on the wall204of the artery200. As the plaque206accumulates, a partial and/or complete occlusion can develop, which can impede and/or even fully stop flow through the artery200(e.g., impede and/or even fully stop the flow of red blood cells203), which can cause negative cardiovascular events that can be life threatening.

As described herein, the thermal systems and methods disclosed herein may include heating an occlusion, such as a thrombus and/or plaque. Heating a thrombus may ease penetration of the thrombus. Heating the thrombus and/or plaque may ease breaking the thrombus and/or plaque apart. Heating the thrombus and/or plaque may ease detachment of the thrombus and/or plaque from the wall of the blood vessel. Heating the thrombus may soften and/or emulsify (e.g., melt, liquify) one or more proteins (e.g., collagen) and/or other thrombus forming elements (e.g., biopolymers) detailed herein. Heating plaque may soften and/or emulsify (e.g., melt, liquify) the plaque, which can be made of lipids, cholesterol, calcium, and/or other substances. The thrombus and/or plaque can soften and/or emulsify when heated to a temperature of 60-120 degrees Celsius (e.g., 60, 70, 80, 90, 100, 110, 120 degrees Celsius), 60-80 degrees Celsius, 65-75 degrees Celsius, and/or 60-70 degrees Celsius. Accordingly, the heated fluid described herein may be heated to 60-120 degrees Celsius (e.g., 60, 70, 80, 90, 100, 110, 120 degrees Celsius), 60-80 degrees Celsius, 65-75 degrees Celsius, 60-70 degrees Celsius, and/or other temperatures. The heated fluid can be heated to 64-70 degrees Celsius, 66-70 degrees Celsius, and/or 68-70 degrees Celsius. The heated fluid can be heated to 70-80 degrees Celsius, 70-72 degree Celsius, 72-74 degree Celsius, 74-76 degree Celsius, 76-78 degree Celsius, and/or 78-80 degrees Celsius. The heated fluid can be heated to 64-66 degrees Celsius and/or 66-68 degrees Celsius. The heated fluid can be heated to about 80 degrees Celsius. The heated fluid can be heated to at least any temperature within the foregoing ranges. The temperature of the heated fluid can be modulated and/or controlled based on temperatures at the occlusion site. For example, the thermal systems and methods disclosed herein can use one or more temperature sensors (e.g., thermocouples) to sense temperatures at the occlusion site, and based on the sensed temperatures, modulate and/or control the temperature of the heated fluid. The systems and/or methods described herein can include insulation to protect anatomy of the patient from heat.

Heating the thrombus and/or plaque may facilitate a glass transition of the thrombus and/or plaque (e.g., soften). For example,FIG.8Aillustrates an example graph representing the stiffness/modulus (MPa) against temperature (k) of thrombi and/or plaque. As shown, at a glass transition temperature (Tg), the one or more proteins (e.g., collagen) and/or other thrombus forming elements may reach a glass transition where they may start flowing more readily in the glassy state (solid to liquid). As shown, at a glass transition temperature (Tg), the lipids, cholesterol, calcium, and/or other plaque forming elements may reach a glass transition where they may start flowing more readily in the glassy state (solid to liquid).FIG.8Billustrates an example graph representing the specific volume of thrombus and/or plaque forming elements against temperature. Once again, at a glass transition temperature (Tg), the thrombus and/or plaque may reach a glass transition. When heated to the glass transition temperature, the thrombus forming elements and/or plaque forming elements may change from a first state (e.g., hard state) to a second state softer than the first state. When heated to the glass transition temperature, the thrombus forming elements and/or plaque forming elements may decrease in viscosity.

The thermal systems and methods described herein may heat thrombi and/or plaque to a temperature sufficient to facilitate a glass transition, which can include softening and/or emulsifying (e.g., melting, liquifying). The thermal systems and methods described herein may heat thrombi and/or plaque to decrease viscosity. The temperature to soften the thrombus and/or plaque may be the glass transition temperature of the thrombus and/or plaque. The temperature to emulsify (e.g., melt, liquify) the thrombus and/or plaque may be higher than the transition temperature. The temperatures to soften the thrombi and the plaque may be different. The temperatures to emulsify the thrombus and plaque may be different. Thrombi and/or plaque can be heterogeneous. Different regions of a thrombus and/or plaque can emulsify at different rates at different temperatures. In some variants, altering a temperature of the applied heat based on the characteristics of the thrombus and/or plaque can be beneficial. For example, it may be beneficial to raise a temperature of the applied heat when interfacing with a region of a thrombus with chronic characteristics compared to when interfacing with a region of the thrombus with acute characteristics. In some variants, the systems and methods described herein can alter the temperature of the applied heat based on the characteristics of the thrombus and/or plaque with which the heated fluid is interfacing.

As described herein, the thermal system and methods described herein may deliver heated fluid to a thrombus and/or plaque to soften and/or emulsify the thrombus and/or plaque. The heated fluid can be heated by way of a variety of techniques which can at least include indirect or direct heat with one or more energy sources, which may at least include heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, ultrasound, heated fluid, nuclear, and/or others. The fluid can held in a reservoir (e.g., tank, bag, bottle, container, syringe, chamber, vessel, compartment, etc.) prior to delivery. The fluid can be heated in the reservoir, during transport to the occlusion site (e.g., plaque, thrombus, and/or other occlusion), and/or at delivery to the occlusion site. The fluid can include a variety of constituents. The fluid can be a saline solution such as a balanced salt solution. The fluid can include one or more medicaments, which can include a thrombolytic agent, such as tissue plasminogen activator (tPA) and/or urokinase that can assist in dissolving the thrombus and/or plaque, and/or a bioactive agent, such as an anti-inflammatory and/or an anti-restenosis drug that can promote healing and/or prevent the formation of new thrombi and/or plaque. The heated fluid can be used to penetrate and/or cross over a thrombus, which can include by way of a fluid jet. The heated fluid can be used to soften and/or emulsify thrombi and/or plaque for aspiration from a blood vessel. The temperature, pressure, and/or flow rate of the heated fluid can be adjusted based on sensed conditions at the occlusion site.

FIG.9illustrates a thrombus108in a vein104. As shown, the thrombus108is disposed downstream of the valve110in the pocket112, which can impede function of the valve110and/or impede blood flow through the vein104.

FIGS.10A-10Eillustrate a method of crossing a thrombus with heated fluid. As illustrated inFIG.10A, a catheter300(e.g., working catheter, aspiration catheter) can be navigated to an occlusion site (e.g., proximal of an occlusion site). In some variants, a guidewire can be advanced through the blood vessel system (e.g., venous or arterial) to the occlusion site, which can be performed using fluoroscopic guidance. The catheter300can be advanced over the guidewire to the occlusion site. The guidewire can be removed, leaving the catheter300in place. A catheter302(e.g., inner catheter, aspiration catheter) can be advanced distal of the catheter300to the thrombus108.

As illustrated inFIG.10B, a fluid jet306, which can be a stream of fluid, flow of fluid, etc., can be directed out of the distal end of the catheter302to interface with the thrombus108. The fluid jet306can be heated to any of the temperatures described herein. The heat from the fluid jet306can ease penetration and/or crossing over of the thrombus108. The heat from the fluid jet306can soften and/or emulsify a core (e.g., central portion) of the thrombus108. The fluid can be heated in a reservoir (e.g., bag, tank, bottle, chamber, container, etc.). In some variants, the reservoir can be an IV bag. In some variants, the reservoir can be positioned proximate a heating element such as a pad to heat the fluid in the reservoir. In some variants, the fluid can be heated as the fluid travels distally through the catheter302, which can be by way of one or more heating elements. In some variants, the fluid can be heated at the distal end of the catheter302, which can be by way of one or more heating elements disposed at the distal end of the catheter302. As illustrated inFIGS.10C and10D, the catheter302can be advanced distally as the fluid jet306penetrates through the thrombus108until crossing over, as illustrated inFIG.10E. In some variants, the catheter302can include one or more heating elements to directly heat the thrombus108. In some variants, the fluid jet306can cease when the catheter302crosses over the thrombus108. In some variants, the catheter300can include a lumen to aspirate the heated fluid and/or softened and/or emulsified thrombus108. In some variants, the catheter302can include a lumen to aspirate the heated fluid and/or softened and/or emulsified thrombus108. In some variants, aspiration can be facilitate by way of a pump (peristaltic pump), vacuum (e.g., vacuum cannister), etc. The aspiration of the heated fluid can form a plume (e.g., controlled area) for treatment with the heated fluid.

For example, as illustrated inFIG.11A, an irrigation catheter308can be disposed inside the catheter302. The irrigation catheter308can include an open distal end309through which the heated fluid jet306can flow. The catheter302can aspirate the heated fluid and/or softened and/or emulsified thrombus108. In some variants, the open distal end309of the irrigation catheter308may be maintained proximate of the distal end of the catheter302, which can help to localize the fluid jet306. In some variants, the open distal end309of the irrigation catheter308can be advanced distal of the catheter302. In some variants, a pressure in the catheter302can be reduced to facilitate the flow of fluid jet306back into the catheter302(e.g., flow of fluid in fluid jet306can reverse back and into catheter302), which can control the plume (e.g., softening and/or emulsification zone). In some variants, the distal end of the catheter302and/or irrigation catheter308can be at an angle (e.g., less than 15, 15, 30, 45, 60, 75, 90, or more than 90 degrees) relative to the longitudinal axis of the catheter302and/or irrigation catheter308, which can avoid the fluid jet306jetting forward. In some variants, the irrigation catheter308can include a curve to face a distal opening of the irrigation catheter308in different directions, which can include facing in a proximal direction. As shown inFIG.11A, the opening into the catheter302can be offset at a forward plane relative to the opening into the irrigation catheter308, which can control the plume (e.g., softening and/or emulsification zone) of the heated fluid. For example, the plume (e.g., softening and/or emulsification zone) can include a funnel and/or conde shape. The configuration of the plume can protect a wall of the blood vessel and/or other areas that are not intended to be exposed to treatment.

In some variants, the catheter302can be an irrigation catheter and the catheter308can be an aspiration catheter. For example, irrigation can be performed in the periphery and aspiration in the middle (e.g., concentric) with low pressure at the middle to reverse the flow of irrigation fluid back into the aspiration catheter to control the plume. In some variants, irrigation can be performed through peripheral apertures and aspiration can be performed centrally (e.g., at a distal open end of the aspiration catheter).

As illustrated inFIG.11B, the irrigation catheter308can include one or more heated elements310(e.g., metal and/or metal alloy elements that can be heated). The one or more heated elements310can be disposed at the distal end309of the irrigation catheter308, which can include surrounding the distal end309(e.g., open distal end309). In some variants, fluid traveling through the irrigation catheter308can be heated by the one or more heated elements310. As illustrated inFIG.11C, a temperature sensor312can be disposed at the heated fluid jet306to sense the temperature. In some variants, the temperature of the fluid jet306(e.g., one or more heated elements310) can be adjusted based on the temperature sensed by the temperature sensor312. As illustrated inFIG.11D, in some variants, the irrigation catheter308can include a closed distal end314and one or more lateral openings316. The one or more lateral openings316can be open in a direction that is angled and/or generally perpendicular relative to the longitudinal axis of the irrigation catheter308, which can facilitate rapid aspiration by way of the catheter302to localize the heated fluid jet306. In some variants, the distal end314may be advanced distally of the distal end of the catheter302. The heated fluid for the fluid jet306can be heated by way of indirect or direct heat with one or more energy sources, which may at least include heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, ultrasound, heated fluid, nuclear, and/or others.

FIGS.12A-12Dillustrate a method of penetrating and/or crossing a thrombus108with a heated element304(e.g., heated member, heated wire, heated guidewire, heated tip, heated end). As detailed above in reference toFIG.12A, the catheter302can be advanced to proximate the thrombus108. As illustrated inFIG.12B, a heated element304can be deployed from within the catheter302and advanced distally through the thrombus108. The catheter302can be advanced with the heated element304in some variants to enable the distal end of the catheter302to cross over the thrombus108, as illustrated inFIG.12D. As described herein, the heated element304can be heated to at least temperatures described herein. The heated element304may be heated directly or indirectly with one or more energy sources, which may at least include heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, ultrasound, heated fluid, nuclear, and/or others. The heat from the heated element304can ease penetration through the thrombus108. The heat from the heated element304can soften and/or emulsify the thrombus108, which can include emulsifying a center (e.g., core) of the thrombus108. With the distal end of the catheter302distal of the thrombus108, the heated element304can be retracted through the inner catheter302, leaving the catheter302in place, as illustrated inFIG.12D.

FIGS.13A-13Cillustrate a method of delivering an irrigation and aspiration catheter318of a thermal system301to an occlusion site. As illustrated inFIG.13A, the irrigation and aspiration catheter318can be advanced distally of the catheter302. As illustrated inFIGS.13B and13C, the catheter302can be retracted proximally to expose the irrigation and aspiration catheter318. The irrigation and aspiration catheter318can include a distal balloon320and/or proximal balloon322. The irrigation and aspiration catheter318can include one or more apertures324positioned between the distal balloon320and proximal balloon322. In some variants, a distal end of the irrigation and aspiration catheter318can be heated and can be used to penetrate and/or cross over the thrombus108, which can include facilitating the cross over of the catheter302which can replace or cooperate with the heated element304. In some variants, a distal end of the catheter302can be heated and can be used to penetrate and/or cross over the thrombus108, which can replace or cooperate with the heated element304.

FIGS.14A and14Billustrate a method of expanding (e.g., inflating) the distal balloon320and proximal balloon322to contact a wall of the blood vessel. The expansion of the distal balloon320and proximal balloon322can fluidically isolate the segment of the blood vessel, e.g., vein104, between the distal balloon320and proximal balloon322. The distal balloon320and the proximal balloon322can be expanded (e.g., inflated) with a variety of techniques, which can at least include filling with fluid and/or gas. The distal balloon320and the proximal balloon322can be expanded (e.g., inflated) manually and/or automatically.

With the occlusion site (e.g., thrombus108and/or plaque) fluidically isolated by the distal balloon320and proximal balloon322from the remainder of the blood vessel (e.g., vein104), heated fluid334can be delivered to the occlusion site by way of the apertures324in the irrigation and aspiration catheter318, as illustrated inFIGS.15A and15B, to soften and/or emulsify the thrombus108and/or plaque. As illustrated inFIG.15C, the apertures324can be disposed circumferentially around the irrigation and aspiration catheter318. As illustrated inFIG.15D, the apertures324can be disposed on one side of the irrigation and aspiration catheter318. The apertures324can be varying shapes and/or sizes. The apertures324can be the same size and/or shape.

As illustrated inFIGS.16A-16F, the softened and/or emulsified thrombus108and/or plaque can be aspirated by way of the apertures324. In some variants, the irrigation and aspiration catheter318can cease delivering heated fluid to the occlusion site prior to aspiration. In some variants, the irrigation and aspiration catheter318can simultaneously deliver heated fluid to the occlusion site and aspirate the softened and/or emulsified thrombus108and/or plaque. In some variants, some of the apertures324can be used for delivering the heated fluid to the occlusion site while others can be used to aspirate the softened and/or emulsified thrombus108and/or plaque. In some variants, the heated fluid can be aspirated by way of the apertures324. In some variants, the blood aspirated by the apertures324can be returned after filtering. The aspirated matter (e.g., heated fluid, softened and/or emulsified thrombus108and/or plaque, etc.) can be directed to a waste reservoir (e.g., tank, bag, bottle, container, syringe, chamber, vessel, compartment, etc.).

FIGS.17A and17Billustrate cross-sectional views of example catheter configurations to deliver heated fluid to an occlusion site and aspirate matter (e.g., heated fluid, softened and/or emulsified thrombus and/or plaque, etc.) from the occlusion site. As illustrated inFIG.17A, the distal balloon320can be inflated and/or deflated with a distal balloon pneumatic lumen328that can deliver and/or remove gas and/or fluid from the distal balloon320. The irrigation and aspiration catheter318can deliver heated fluid to the occlusion site and/or aspirate matter from the occlusion site. In some variants, the distal balloon pneumatic lumen328can be disposed in a catheter upon which the distal balloon320is disposed that can be delivered through the irrigation and aspiration catheter318. In some variants, the proximal balloon can be disposed on the irrigation and aspiration catheter318. As illustrated inFIG.17B, a separate irrigation catheter308can be used to deliver heated fluid to an occlusion site and a separate aspiration catheter330can be used to aspirate matter from the occlusion site. The irrigation catheter308can be delivered through the aspiration catheter330. The distal balloon320can be inflated and/or deflated with a distal balloon pneumatic lumen328that can deliver and/or remove gas and/or fluid from the distal balloon320. In some variants, the distal balloon pneumatic lumen328can be disposed in a catheter upon which the distal balloon320is disposed that can be delivered through the irrigation catheter308. In some variants, the proximal balloon can be disposed on the aspiration catheter330.

FIGS.18A and18Billustrate example catheters of a thermal system337to deliver heated fluid to an occlusion site and aspirate matter (e.g., softened and/or emulsified thrombus and/or plaque) from the occlusion site. As illustrated inFIG.18A, the thermal system337can include a catheter336(e.g., outer catheter, working catheter). The catheter336can include a proximal balloon322, which can be disposed on a distal portion thereof. A catheter328(e.g., inner catheter, distal-balloon catheter) can be advanced distally out of the catheter336. The catheter328can include the distal balloon320. The thermal system337can include an irrigation catheter308that can be advanced out of the catheter336. The irrigation catheter308can include an aperture324through which heated fluid can be delivered to an occlusion site. In some variants, the irrigation catheter308can include a plurality of apertures324to deliver heated fluid. The thermal system337can include an aspiration catheter330that can be advanced out of the catheter336. The aspiration catheter330can include an aperture332to aspirate matter (e.g., heated fluid, softened and/or emulsified thrombus and/or plaque, etc.) from an occlusion site. In some variants, the aspiration catheter330can include a plurality of apertures332. In some variants, the catheter336can be a multi-lumen catheter, which can include a lumen for each of the irrigation catheter308, aspiration catheter330, and/or catheter328. In some variants, the catheter336can include a single lumen for the irrigation catheter308, aspiration catheter330, and catheter328. As shown inFIG.18B, heated fluid334can be delivered to an occlusion site by way of the aperture324and matter (e.g., heated fluid, softened and/or emulsified thrombus and/or plaque, etc.) can be aspirated by way of the aperture332. In some variants, the aperture324and/or aperture332can be elongate apertures. In some variants, the aperture324and/or aperture332can include a curved periphery. In some variants, the aperture324and aperture332can face opposite directions.

The catheters of the thermal system337can be positioned at an occlusion site at least using the techniques described herein. For example, a guidewire can be navigated to proximal of an occlusion site. A catheter300can be advanced over the guidewire to the occlusion site. An inner catheter (e.g., catheter302) can be advanced distally out of the catheter300. A heated element (e.g., heated element304) can be advanced distally of the distal end of the inner catheter. The heated element and the inner catheter can be advanced together with the heated element easing penetration and crossing over of the occlusion (e.g., thrombus). With the distal end of the inner catheter distal of the occlusion (e.g., thrombus and/or plaque), the heated element can be retracted. The catheter336, irrigation catheter308, aspiration catheter330, and/or catheter328can be advanced within the inner catheter such that the distal balloon320is distal of the occlusion site and the proximal balloon322is proximal of the occlusion site. The inner catheter can be retracted to expose the proximal balloon322, aperture324of the irrigation catheter308, aperture332of the aspiration catheter330, and/or distal balloon320. In some variants, the irrigation catheter308and/or aspiration catheter330can be advanced out of the catheter336to position the aperture324of the irrigation catheter308and aperture332of the aspiration catheter330at the occlusion site (e.g., at the thrombus and/or plaque). As illustrated inFIGS.19A and19B, the distal balloon320and proximal balloon322can be expanded (e.g., inflated) to fluidically isolate the segment of the blood vessel (e.g., vein104) between the distal balloon320and proximal balloon322from the remainder of the blood vessel (e.g., vein104).

As illustrated inFIGS.20A-20G, heated fluid334can be delivered to the thrombus108by way of the aperture324of the irrigation catheter308to soften and/or emulsify the thrombus108. The heated fluid334, softened and/or emulsified thrombus108, and/or other matter can be aspirated through the aperture332of the aspiration catheter330. The irrigation catheter308and/or aspiration catheter330can be advanced distally through the thrombus108as the heated fluid334softens and/or emulsifies the thrombus108. In some variants, the irrigation catheter308can deliver the heated fluid334while the aspiration catheter330aspirates. In some variants, the irrigation catheter308can deliver the heated fluid334and the aspiration catheter330can aspirate at different times (e.g., in sequence). As shown inFIGS.20H and20I, the distal balloon320and proximal balloon322can be deflated for removal. Once the distal balloon320and the proximal balloon322are deflated, the catheter336, irrigation catheter308, aspiration catheter330, and/or catheter328can be retracted proximally into the catheter300for removal.

FIGS.21A and21Billustrate cross-sectional views of example catheter configurations to deliver heated fluid to an occlusion site and aspirate matter (e.g., heated fluid, softened and/or emulsified thrombus and/or plaque, etc.) from the occlusion site. As illustrated inFIG.21A, the aspiration catheter330and the irrigation catheter308can be disposed on opposite sides of the catheter328, which can include being on opposite sides of the distal balloon catheter328. The catheter328can include a lumen (e.g., pneumatic lumen, fluid lumen, gas lumen) for fluid and/or gas to inflate or deflate the distal balloon320. In some variants, the catheter336can include a single lumen for the irrigation catheter308, catheter328, and/or aspiration catheter330. In some variants, the catheter336can include a plurality of lumens (e.g., three) with one lumen for each of the irrigation catheter308, catheter328, and/or aspiration catheter330. The catheter328can be centered within the catheter336(e.g., the lumen for the catheter328can be centered within the catheter336). The catheter336can include a lumen (e.g., pneumatic lumen, fluid lumen, gas lumen) to inflate or deflate the proximal balloon. As illustrated inFIG.21B, in some variants, the pneumatic lumen338can include a pneumatic lumen338, which can be a fluid lumen, to inflate or deflate the proximal balloon. In some variants, the aspiration catheter330and the irrigation catheter308can deploy from the same lumen319of the catheter336. In some variants, the aspiration catheter330and irrigation catheter308can deploy from a multi-lumen catheter disposed in the lumen319. In some variants, the catheter328can be disposed laterally of the lumen319.

FIGS.22A and22Billustrate an example catheter arrangement of a thermal system339to deliver heated fluid to an occlusion site and aspirate material (e.g., heated fluid, softened and/or emulsified thrombus and/or plaque, etc.). The thermal system339can include a catheter336(e.g., outer catheter, working catheter). The catheter336can include a proximal balloon322, which can be disposed on a distal portion thereof. The catheter336can aspirate material from an occlusion site. A catheter328(e.g., inner catheter, distal-balloon catheter) can be advanced distally out of the catheter336. The catheter328can include a distal balloon320. The thermal system337can include an irrigation catheter308that can be advanced out of the catheter336. The irrigation catheter308can include one or more apertures324through which heated fluid can be delivered to an occlusion site. The irrigation catheter308can be advanced along the catheter328to position the one or more apertures324of the irrigation catheter308distal of the proximal balloon322and proximal of the distal balloon320. As illustrated inFIG.22B, a heated element304(e.g., heated wire, heated guidewire) can be deployed distally from (e.g., distally out of) the catheter328to ease penetration and/or crossing over an occlusion to position the distal balloon320distal of the occlusion site and/or position the one or more apertures324of the irrigation catheter308at the occlusion. In some variants, a distal end of the catheter328can include one or more heating elements to ease penetration and/or crossing over an occlusion, which can cooperate with the heated element304or replace the heated element304so that a separate heated element304is not used. The proximal portions of the heated element304can be insulated.

In use, a guidewire can be navigated to proximal of an occlusion site (e.g., site of thrombus and/or plaque). The catheter336and irrigation catheter308, which may be disposed inside the catheter336, can be advanced over the guidewire to proximal of the occlusion site. The proximal balloon322can be inflated to contact a surrounding wall using the techniques described herein, which can anchor the catheter336in place in the blood vessel (e.g., vein or artery). The guidewire can be removed. The catheter328can be inserted and advanced through the catheter336. A distal end of the catheter328can be advanced distal of a distal end of the catheter336and/or a distal end of the irrigation catheter308. A heated element304can be advanced distally out of the catheter328. The heated element304can be heated using at least the techniques described herein. The heated element304can be advanced through the occlusion to crossover the occlusion. The catheter328can be advanced with the heated element304to position the distal balloon320distal of the occlusion. The heat from the heated element304can ease penetration through the occlusion, which can include softening and/or emulsifying a core (e.g., central portion) of the occlusion. The distal balloon320can be inflated using at least the techniques described herein. The inflated distal balloon320and proximal balloon322can isolate (e.g., fluidically isolate) the segment of the blood vessel between the distal balloon320and proximal balloon322. Heated fluid can be delivered to the occlusion site by way of the apertures324of the irrigation catheter308. The heated fluid can be heated to at least the temperatures described herein. As described herein, the heated fluid can be heated in a reservoir, during transport from the reservoir to the occlusion site, and/or at the occlusion site (e.g., at the apertures324). The heated fluid can soften and/or emulsify the occlusion. The catheter336can aspirate the softened and/or emulsified occlusion, heated fluid, and/or other material. In some variants, aspirated blood can be filtered and returned to the blood vessel. In some variants, the guidewire can be heated to facilitate penetration and/or crossover of the occlusion, which can replace or cooperate with the heated element304. In some variants, the catheter328can include a heated element at a distal end thereof that can facilitate penetration and/or crossover of the occlusion, which can replace or cooperate with the heated element304.

The features of the thermal system339can be various sizes. For example, the proximal balloon322can include an outside diameter of twenty millimeters when inflated. The distal balloon catheter328can have an inside diameter (e.g., internal lumen diameter) of 1.66 millimeters (e.g., 5 Fr). The heated element304can have an outside diameter of 1.5 millimeters. The distal balloon320can include an outside diameter of twenty millimeters when inflated. The foregoing dimensions are exemplary and should not be considered limiting.

FIG.23Aillustrates catheters of a thermal system341positioned to deliver heated fluid to a thrombus108for softening and/or emulsification to facilitate aspiration. As illustrated, a guidewire340can be routed to a thrombus108. In some variants, the guidewire340can be heated, which can include heating a distal end of the guidewire340. The guidewire340can penetrate and crossover the thrombus108. The thermal system341can include a catheter336with a proximal balloon322. The thermal system341can include a distal balloon catheter309with a distal balloon320. The distal balloon catheter309can be deployed from within the catheter336. The catheter336and distal balloon catheter309can be advanced over the guidewire340to proximate the thrombus108. The proximal balloon322can be inflated using at least the techniques described herein. The distal balloon catheter309can be advanced over the guidewire340to position the distal balloon320distal of the thrombus108. The distal balloon320can be inflated using at least the techniques described herein. With the proximal balloon322and distal balloon320inflated, the segment of the vein104between the proximal balloon322and distal balloon320can be isolated (e.g., fluidically) from the remainder of the vein104. Heated fluid can be delivered to the thrombus108by way of the catheter336(e.g., one or more lumens of the catheter336). The heated fluid can soften and/or emulsify the thrombus108. The softened and/or emulsified thrombus108, heated fluid, and/or other material can be aspirated through the catheter336(e.g., one or more lumens of the catheter336) for removal. In some variants, the aspirated blood can be filtered and returned to the vein104. In some variants, the catheter336can be a multi-lumen catheter (e.g., include multiple lumens). For example, as illustrated in the cross-section shown inFIG.23B, the catheter336can include two lumens, which can include an irrigation lumen344to deliver heated fluid to the thrombus108and an aspiration lumen346to aspirate softened and/or emulsified thrombus108, heated fluid, and/or other material. The irrigation lumen344can be a working lumen through which the distal balloon catheter309can be deployed and/or guidewire340. As illustrated in the cross-section shown inFIG.23C, the catheter336can include three lumens, which can include a irrigation lumen344, an aspiration lumen346, and/or a working lumen348through which the distal balloon catheter309and/or guidewire340can be deployed. The distal balloon catheter309can include apertures to deliver the heated fluid. In some variants, a separate irrigation catheter can be advanced through the irrigation lumen344to deliver the heated fluid.

FIG.24Aillustrates an irrigation and aspiration catheter318of a thermal system343positioned to deliver heated fluid to a thrombus108for softening and/or emulsification to facilitate aspiration. As illustrated, the irrigation and aspiration catheter318can include a distal balloon320and a proximal balloon322. A guidewire340can be navigated to a thrombus108. The guidewire340can penetrate and/or crossover the thrombus108. The guidewire340, in some variants, can be heated, which can ease penetration and/or crossover. The irrigation and aspiration catheter318can be advanced over the guidewire340to position the distal balloon320distal of the thrombus108and the proximal balloon322proximal of the thrombus. The distal balloon320and proximal balloon322can be inflated, which can isolate (e.g., fluidically isolate) the segment of the vein104between the distal balloon320and proximal balloon322. As illustrated inFIG.24B, heated fluid can be delivered to the thrombus108by way of one or more apertures354of the irrigation and aspiration catheter318. The heated fluid can soften and/or emulsify the thrombus108. The softened and/or emulsified thrombus108can be aspirated by way of one or more apertures356of the irrigation and aspiration catheter318, as illustrated inFIG.24B. The irrigation and aspiration catheter318can, in some variants, irrigate and aspirate simultaneously or in sequence (e.g., stages). As illustrated in the cross-section shown inFIG.25, the irrigation and aspiration catheter318can include an irrigation lumen350to deliver heated fluid and/or an aspiration lumen352to facilitate aspiration.

FIG.26Aillustrates a schematic of a thermal system400(e.g., thermal thrombectomy system, thermal atherectomy system, thrombectomy system, atherectomy system). The thermal system400can be used to emulsify and/or aspirate a thrombus, plaque, and/or other occlusive material from a blood vessel, such as a vein and/or artery. The thermal system400can include more or less features than illustrated. The thermal system400can include any of the features described in relation to other systems, devices, catheters, and/or methods described herein.

The thermal system400can include a thermal control system500(e.g., temperature control system). The thermal control system500can control the temperature (e.g., heating) of the heating element to penetrate and crossover an occlusion and/or the heated fluid, which can be used to penetrate, soften, and/or emulsify an occlusion. The thermal control system500can control the temperature (e.g., heat) other heating elements and/or guidewires described herein.

The thermal control system500can include one or more heaters508(e.g., variable current driver, current driver) that can heat one or more heating elements510, which can include heating by way of electricity and/or the other techniques described herein. The one or more heaters508can heat the one or more heating elements510to at least temperatures described herein or above to accommodate for heat loss. The one or more heating elements510can heat the heated fluid and/or include the heated element304and/or other heated elements described herein. Wiring can be routed through a device interface512to the heated element304that is disposed inside the blood vessel of the patient. A heating element510can heat fluid in a tank418(e.g., reservoir, bag, bottle, container, syringe, chamber, vessel, compartment, etc.) of a fluid delivery system416for delivery. In some variants, a heating element510can heat fluid in a catheter and/or at a distal end of a catheter.

The thermal control system500can include a temperature sensor interface502(e.g., thermocouple interface, T-type thermocouple interface). The temperature sensor interface502can interface with one or more temperature sensors506(e.g., thermocouple(s)). The one or more temperature sensor506can sense the temperature of the heated fluid in the tank418, in the catheter(s), and/or at the distal end(s) of the catheter(s). Wiring for a temperature sensor506can be routed through a device interface512to within a catheter and/or at the distal end of the catheter. The thermal control system500can modulate the temperature of the one or more heating elements510based on temperatures sensed by the one or more temperature sensors506. The thermal control system500can include a safety sensing unit504. The safety sensing unit504can, if certain temperatures are detected by the one or more temperature sensors506, initiate a safety protocol, which can at least include cease applying heat by way of the heater508, cease pumping fluid to the occlusion site, cease aspirating matter from the occlusion site, close one or more valves, open one or more valves, etc.

The thermal system400can include a fluid delivery system416. The fluid delivery system416can deliver fluid to an occlusion by way of a catheter. The fluid delivery system416can include a tank418(e.g. reservoir, bag, bottle, container, syringe, chamber, vessel, compartment, etc.) that can hold a fluid. In some variants, the fluid can be heated in the tank418. For example, one or more heating elements510of the thermal control system500can be disposed at the tank418to heat the fluid therein. The fluid in the tank418can be heated to the temperatures described herein or higher to account for heat loss. A temperature sensor420(e.g., thermocouple) can be disposed at the tank418to measure a temperature of the fluid. The temperature sensed by the temperature sensor420can be communicated to the thermal control system500to modulate the temperature of the fluid based on the measured temperature. The fluid delivery system416can include a pump424to move fluid from the tank418to an occlusion site by way of a catheter, which can include passing through the device interface512. The fluid delivery system416can include a flow meter426to sense the flow rate of the fluid. The fluid delivery system416can include a filter422that can filter the fluid prior to delivery at the occlusion site. The fluid delivery system416can include a valve428(e.g., solenoid valve, proportional solenoid valve) that can open and close.

The thermal system400can include a fluid return system430(e.g., aspiration system). The fluid return system430can aspirate softened and/or emulsified thrombus and/or plaque, heated fluid, and/or other material from an occlusion site in a blood vessel. The fluid return system430can include a tank432(e.g. reservoir, bag, bottle, container, syringe, chamber, vessel, compartment, etc.) that can hold matter aspirated from the blood vessel (e.g., softened and/or emulsified thrombus and/or plaque, heated fluid, etc.). The thermal system400can include a pump434can move (e.g., suck, aspirate, vacuum, extract, suction, remove) matter from the blood vessel through a catheter into the tank432. The fluid return system430can include a flow meter436that can sense the flow rate of the matter aspirated from the blood vessel as the matter is pumped to the tank432. The fluid return system430can include a valve438(e.g., solenoid valve, proportional solenoid valve) that can open and close.

The thermal system400can include a fluid control system442(e.g., fluid delivery and aspiration control system). The fluid control system442can include one or more pump drivers452. The pump driver(s)452can drive the pump424and/or pump434. The fluid control system442can include one or more flow sensor(s)456that can sense the flow rates in the thermal system400. The pump driver(s)452can make adjustments based on sensed flow rates. The fluid control system442can include one or more valve actuation units458that can acuate the valves in the thermal system400, which can include the valve428and/or valve438. The fluid control system442can include a flow safety unit454. When the one or more flow sensors456sense certain flow rates, the flow safety unit(s)454can initiate one or more safety protocols (e.g., cease driving the pump424and/or pump434with the one or more pump drivers452, close the valve428and/or valve438, etc.).

In some variants, the fluid return system430can be replaced by a pneumatic system440. The pneumatic system440can aspirate softened and/or emulsified thrombus and/or plaque, heated fluid, and/or other material from an occlusion site in a blood vessel. The pneumatic system440can include the tank432to hold matter aspirated from the blood vessel. The pneumatic system440can be coupled to a vacuum source450, which can include a wall vacuum source. The pneumatic system440can include a filter444. The filter444can filter unwanted matter from flowing to the vacuum source450. The pneumatic system440can include a pressure regulator446that can regulate the pressure in the pneumatic system440. The pneumatic system440can include a light source448, such as a bulb, LED, etc.

The thermal system400can include a manual balloon control system402(e.g., balloon control system). The manual balloon control system402can include a proximal balloon control system404and/or a distal balloon control system408. The proximal balloon control system404can inflate and/or deflate the proximal balloon. The distal balloon control system408can inflate and/or deflate the distal balloon. The proximal balloon control system404can include a syringe406that can be filled with a fluid and/or gas that can be urged into the proximal balloon for inflation and urged back into the syringe406for deflation. The proximal balloon control system404can include a valve412(e.g., stopcock) that can open or close to prevent or allow movement of fluid and/or gas by the syringe406. The distal balloon control system408can include a syringe410that can be filled with a fluid and/or gas that can be urged into the distal balloon for inflation and urged back into the syringe410for deflation. The distal balloon control system408can include a valve414(e.g., stopcock) that can open or close to prevent or allow movement of fluid and/or gas by the syringe410.

The thermal system400can include a power system460. The power system460can include a battery466, which can be rechargeable. The power system400can include a gauge462. The gauge462can indicate the status of the battery466(e.g., percentage charged, etc.). The power system460can include a charging interface468. The charging interface468can interface with a cable474(e.g., charging cable) that can interface with a power source472(e.g., outlet) to charge the battery466and/or directly power the system400. The power system460can include a power management unit470and/or voltage regulator464.

The system400can include a control system476. The control system476can execute the methods described herein. The control system476can include a controller478(e.g., micro-controller), real-time clock480(e.g., RTC), and/or memory482. The real-time clock480can be used to monitor durations of methods and/or steps of methods described herein (e.g., duration heating element is at a temperature, duration of heated fluid delivery, duration of aspiration, etc.). The real-time clock480can be used to identify triggering events for the system400to respond to. The system400can include a communication interface484(e.g., USB port) that can facilitate connecting the system400to a computing system to communicate data. For example, the thermal system400can be communicatively coupled with a computing device486. A data cable can interface with the communication interface484of the thermal system400and a communication interface490(e.g., USB port) of the computing device486to communicate data. The computing device486can log data from the thermal system400. The computing device486can analyze data from the thermal system400, which can include producing a data log488(e.g., one or more graphs) based on data from the thermal system400.

The system400can include a user interface system492. The user interface system492can include one or more button(s)494, which can at least be used to adjust temperature of the heating element and/or heated fluid, start/stop heating, delivery of heated fluid, and/or aspiration, change modes, adjust flow rates and/or pressure, adjust aperture sizes, open and/or shut valves, power on/off, and/or other adjustments. The user interface system492can, in some variants, include dial(s), switch(es), display(s), touchpad(s), touchscreen(s), knob(s), trigger(s), indicator(s), gauge(s), slider(s), and/or other features. The user interface system492can include indicator(s)496(e.g., indicator lights, such as LEDs). The indicator(s)496can visually indicate when the system400is ready for operation and/or not ready for operation. The indicator(s)496can visually indicate when the system400is aspirating, delivering heated fluid, and/or heating a heating element. The indicator(s)496can indicate the charge level of the battery466. The indicator(s)496can indicate when the system400is communicating with another computing system (e.g., transmitting data). The indicator(s)496can emit warnings. The indicator(s)496can emit various colors and/or patterns of light. The user interface system492can include a speaker(s)498(e.g., buzzer(s)), which can emit audible sounds to communicate warnings, alert of safety issues, and/or emit sounds when various actions are performed (e.g., power on/off). In some variants, the user interface system492can include one or more displays, touchscreens, microphones for spoken commands, etc. In some variants, the indicator(s)496, speaker(s)498, display, touchscreen, etc. can indicate the status of the system400, which can at least include indicating when the heated fluid is being delivered to an occlusion site, how long the heated fluid has been at a temperature or above a temperature, a temperature of the heated fluid, when the system400is aspirating, etc.

The system400, in some variants, can include a wired communication interface and/or a wireless communication interface to communicate with other computing devices. The system318can include a processor and/or other hardware to perform the methods described herein.

In some variants, the thermal system400can include the pneumatic system524(e.g., aspiration system) to facilitate aspiration, as illustrated inFIG.26B. The pneumatic system524can be used to aspirate heated fluid, thrombus, plaque, and/or other occlusion from the blood vessel of the patient. The pneumatic system524can include a pump534(e.g., vacuum pump) with access to the ambient environment528, accumulator532, relief valve530with access to the ambient environment528, pressure gauge536, filter538, tank540(e.g. reservoir, bag, bottle, container, syringe, chamber, vessel, compartment, etc.), and/or valve542(e.g., solenoid valve). The tank540can receive aspirated material (e.g., thrombi and/or other occlusive material). The system400can include a gauge to indicate the fill level of the tank540, which can include a gauge of the user interface492. The pneumatic system524can be operatively coupled to the device interface5121to facilitate aspiration.

The system400can include a pneumatic control system514(e.g., aspiration control system), as illustrated inFIG.26B. The pneumatic control system514can include a pump driver516. The pump driver516can drive the vacuum pump534. The pneumatic control system514can include a pressure sensor520, which can sense pressures within the thermal system400and/or the blood vessel. The pneumatic control system514can include a valve actuation unit522that can acuate (e.g., open, close) the solenoid valve542. The pneumatic control system514can include a pressure safety unit518that can monitor pressures within the thermal system400and/or the blood vessel. The pressure safety unit518can, when certain pressures are detected, initiate a safety protocol (e.g., cease driving the vacuum pump534with the pump driver516).

As illustrated inFIG.26C, the thermal system400can include a balloon control system560. The balloon control system560can inflate and/or deflate the distal and/or proximal balloons, which can include urging gas and/or fluid into the distal and/or proximal balloons for inflation and/or urging gas and/or fluid out of the distal and/or proximal balloons for deflation. The balloon control system560can include a balloon inflation system544and/or a balloon deflation system558. The balloon inflation system544can inflate the distal and/or proximal balloons. The balloon deflation system558can deflate the distal and/or proximal balloons.

The balloon inflation system544can include a pump548, accumulator550, relief valve552with access to the ambient environment526, accumulator pressure gauge554, filter546, and/or valve542(e.g., solenoid valve). The balloon inflation system544can urge fluid and/or gas to the proximal balloon and/or distal balloon for inflation. The balloon deflation system558can include a pump534(e.g., vacuum pump) with access to the ambient environment526, accumulator532, relief valve530with access to the ambient environment528, pressure gauge536, filter538, and/or valve542(e.g., solenoid valve). The balloon deflation system558can urge fluid and/or gas out of the proximal balloon and/or distal balloon for deflation.

A valve562(e.g., solenoid valve) that can open or close can be disposed proximal of the proximal balloon. With the valve562closed, gas and/or fluid cannot be urged into or out of the proximal balloon. A valve564(e.g., solenoid valve) that can open or close can be disposed proximal of the distal balloon. With the valve564closed, gas and/or fluid cannot be urged into or out of the distal balloon. The thermal system400can include a pressure gauge566that can sense a pressure in the proximal balloon. The thermal system400can include a pressure gauge568that can sense a pressure in the distal balloon. The valve562can be opened and the valve564closed to inflate and/or deflate the proximal balloon. The valve564can be opened and the valve562closed to inflate and/or deflate the distal balloon.

FIGS.27A and27Billustrate catheters of a thermal system570that deliver heated fluid to an occlusion to soften and/or emulsify the occlusion for aspiration. The thermal system570can include a multi-lumen tube572(e.g., multi-lumen catheter, catheter, extrusion). The multi-lumen tube572can include a proximal balloon322. The proximal balloon322can be disposed on a distal portion (e.g., end) of the multi-lumen tube572. The multi-lumen tube572can include one or more apertures575through which gas and/or fluid can be delivered to the proximal balloon322for inflation and/or removed for deflation. The multi-lumen tube572can include a proximal balloon lumen612, which can be plugged at a distal end. The multi-lumen tube572can be fluidically coupled with the aperture575. The multi-lumen tube572can be coupled to a Y connector574(e.g., hub, splitting hub). The Y connector574can include a port576through which gas and/or fluid can be introduced to inflate and/or removed to deflate the proximal balloon322. A syringe578can be coupled to the port576. The syringe578can hold gas and/or fluid that can be urged through the port576to the proximal balloon322and/or urged from the proximal balloon322out of the port576. The proximal balloon lumen612can guide fluid and/or gas introduced through the port576of the Y connector574to the aperture575of the multi-lumen tube572to inflate the proximal balloon322. The proximal balloon lumen612can guide fluid and/or gas removed from the proximal balloon322through the aperture575back to the syringe578by way of the port576of the Y connector574. The Y connector574can fluidically couple the proximal balloon lumen612to the port576. The Y connector574can be fluidically coupled with the aspiration lumen610.

The thermal system400can include a Y connector580. The Y connector580can include a valve, such as a hemostasis valve, to impede back flow. The Y connector580can be coupled to the Y connector574by way of a connector594. The Y connector580can include an aspiration port582. The aspiration port582can be fluidically coupled with an aspiration lumen610of the multi-lumen tube572, which can also be a working lumen through which other devices are navigated. A pump (e.g., vacuum pump) can be coupled to the aspiration port582to aspirate matter from a blood vessel through the aspiration lumen610of the multi-lumen tube572, which can include aspirating into a reservoir.

An irrigation catheter308can be disposed through the aspiration lumen610of the multi-lumen tube572. The irrigation catheter308can be advanced distally out of the aspiration lumen610. The irrigation catheter308can include one or more apertures324through which heated fluid can be delivered to an occlusion (e.g., thrombus and/or plaque). The one or more apertures324can be disposed on a distal portion (e.g., end) of the irrigation catheter308. The irrigation catheter308can include an irrigation catheter hub584. The irrigation catheter hub584can be coupled to a Y connector586. A connector596can couple the irrigation catheter hub584to the Y connector586. The Y connector586can include a valve, such as a hemostasis valve, to impede back flow. The Y connector586can include an irrigation port588through which heated fluid can be introduced (e.g., provided by a heated fluid delivery system). The heated fluid can travel through the irrigation port588of the Y connector586, through the irrigation catheter308, and out the one or more apertures324to an occlusion to soften and/or emulsify the occlusion. The heated fluid can be pumped into the irrigation port588and urged out the apertures324of the irrigation catheter308. The thermal system570can include a linear actuator590(e.g., Tuohy Borst) to facilitate linear movement of the irrigation catheter308. The irrigation catheter308can be disposed through the connector596, linear actuator590, Y connector580, connector594, Y connector574, and/or through the aspiration lumen610of the multi-lumen tube572.

A distal balloon catheter328can be disposed through the aspiration lumen610of the multi-lumen tube572. The distal balloon catheter328can be disposed through the irrigation catheter308. The distal balloon catheter328can be advanced distally out of the aspiration lumen610and/or irrigation catheter308. The distal balloon catheter328can include a distal balloon320. The distal balloon catheter328can be disposed on a distal portion (e.g., end) of the distal balloon catheter328. The distal balloon catheter328can include one or more apertures through which gas and/or fluid can be delivered to the distal balloon320for inflation and/or removed for deflation. A heated element304(e.g., wire, looped wire) can be disposed in the distal balloon catheter328. The heated element304can be heated to at least the temperatures disclosed herein by way of at least the techniques described herein. The heated element304can be advanced distally out of the distal balloon catheter328. The heated element304can be used to penetrate and/or crossover an occlusion with the distal balloon catheter328to position the distal balloon320distal of the occlusion. The heat from the heated element304can ease penetration and/or crossover. The distal balloon catheter328can include a distal balloon catheter hub598. The distal balloon catheter hub598can be coupled to a syringe600. The syringe600can hold gas and/or fluid that can be urged through the distal balloon catheter328to the distal balloon320for inflation and/or urged from the distal balloon320through the distal balloon catheter328for deflation. The syringe600can be coaxially aligned with the distal balloon catheter hub598. The thermal system570can include a linear actuator592(e.g., Tuohy Borst) to facilitate linear movement of the distal balloon catheter328. The distal balloon catheter328can be disposed through the linear actuator592, Y connector586, connector596, irrigation catheter308, linear actuator590, Y connector580, connector594, Y connector574, and/or aspiration lumen610of the multi-lumen tube572. In some variants, reservoirs (e.g., tanks, bags, bottles, containers, chambers, vessels, compartments, etc.) other than syringes can be used to hold gas and/or fluid to inflate and/or deflate the proximal balloon322and/or distal balloon320. The reservoirs can be fluidically coupled with pumps to move the gas and/or fluid for inflation and/or deflation of the proximal balloon322and/or distal balloon320. As illustrated inFIG.27B, the thermal system570can include a Y connector606with a port608. The syringe600can be coupled to the port608. The Y connector606can be coupled to the distal balloon catheter328. For example, the Y connector606can be coupled to the distal balloon catheter hub598of the distal balloon catheter328. A connector602can couple the Y connector606to the distal balloon catheter hub598. The Y connector606, in some variants, can include a valve (e.g., hemostasis valve). The gas and/or fluid held in the syringe600can be urged through the port608of the Y connector606and into the distal balloon catheter328to inflate the distal balloon320. The thermal system570can include a linear actuator604(e.g., Tuohy Borst) that can be disposed proximal of the Y connector606. In some variants, the linear actuator604can be used to move the heated element304within the distal balloon catheter328.

FIGS.27C and27Dillustrate a distal portion of the catheters of the thermal system570. As shown, the heated element304can be disposed in the lumen305of the distal balloon catheter328. In some variants, the heated element304can be potted in the lumen305of the distal balloon catheter328. The heated element304can plug the distal end of the lumen305, which can impede gas and/or fluid flowing through the distal balloon catheter328to the distal balloon320from escaping through a distal opening of the lumen305. The heated element304can be heated at least to the temperatures described herein. The temperature of the heated element304can be altered, which can include being altered based on sensed conditions at the occlusion site (e.g., temperature at the occlusion site). The heated element304can be heated during penetration and/or crossing over of an occlusion. The heated element304may, in some variants, not be heated once penetration and/or crossing over of the occlusion have been accomplished. In some variants, the heated element304can be fixed in position relative to the distal balloon catheter328. In some variants, the heated element304can be retracted into the lumen305of the distal balloon catheter328and/or deployed distally out from the lumen305of the distal balloon catheter328. The heated element304can include a wire that extends distally, loops, and returns proximally. The heated element304, in some variants, can be removed proximally from the lumen305of the distal balloon catheter328.

FIG.27Eillustrates a cross-sectional view of the multi-lumen tube572with the irrigation catheter308and distal balloon catheter328. The multi-lumen tube572can have an outer diameter of various sizes, which can at least include less than 14 Fr, 14 Fr, or greater than 14 Fr. As shown, the multi-lumen tube572can include a proximal balloon lumen612. The proximal balloon lumen612can be various sizes, which can include less than 1.3 millimeters (e.g., 4 Fr), 1.3 millimeters (e.g., 4 Fr), or larger than 1.3 millimeters (e.g., 4 Fr). As described herein, a distal end of the proximal balloon lumen612can be plugged to prevent escape of the fluid and/or gas flowing through the proximal balloon lumen612to inflate and/or deflate the proximal balloon322. In some variants, a guidewire can be disposed through the proximal balloon lumen612, which may seal the distal end of the proximal balloon lumen612to impede the escape of gas and/or fluid for inflating and/or deflating the proximal balloon322.

The aspiration lumen610of the multi-lumen tube572can be used to aspirate matter (e.g., heated fluid, softened and/or emulsified thrombus and/or plaque, and/or other material) from an occlusion site. The aspiration lumen610can be a working lumen. In some variants, the aspiration lumen610can be braided. The irrigation catheter308and/or distal balloon catheter328can be disposed inside the aspiration lumen610. The distal balloon catheter328can be disposed inside of a lumen311of the irrigation catheter308. Heated fluid can flow in the lumen311of the irrigation catheter308between the distal balloon catheter328and an inner wall of the irrigation catheter308defining the lumen311. The distal end of the lumen311of the irrigation catheter308can be open to enable the distal balloon catheter328to be advanced distally out of the irrigation catheter308. Heated fluid can flow through the lumen311and out of the one or more apertures324and/or open distal end to an occlusion site to soften and/or emulsify an occlusion. Fluid and/or gas to inflate and/or deflate the distal balloon320can flow through a lumen305of the distal balloon catheter328. The distal end of the lumen305can be plugged (e.g., closed) to prevent escape of the fluid and/or gas. The distal end of the lumen305, in some variants, can be plugged by the heated element304. The heated element304can be disposed in the lumen305of the distal balloon catheter328.

FIG.28illustrates an aspiration and working channel port583. The aspiration and working channel port583can be coupled to the Y connector574to fluidically couple with the aspiration lumen610of the multi-lumen tube572. The irrigation catheter308and/or distal balloon catheter328can be disposed through the aspiration and working channel port583to access the aspiration lumen610.

FIG.29Aillustrates the multi-lumen tube572and Y connector574separate from the remainder of the catheters and connectors of the thermal system570.FIG.29Billustrates a cross-sectional view of the multi-lumen tube572to show the proximal balloon lumen612and aspiration lumen610. The size of the aspiration lumen610relative to the size of the proximal balloon lumen612shown inFIG.29Acan be greater compared to the example shown inFIG.27E.FIG.29Cillustrates a guidewire614disposed through the aspiration lumen610of the multi-lumen tube572. As described herein, the guidewire614can be navigated to an occlusion site. The multi-lumen tube572can be advanced over the guidewire614to proximal of the occlusion site. In some variants, the irrigation catheter308and/or distal balloon catheter328can be advanced over the guidewire614to the occlusion site. In some variants, the guidewire614can be retracted prior to navigating the irrigation catheter308and/or distal balloon catheter328through the aspiration lumen610to the occlusion site. The guidewire614can be various sizes, which can include 5 Fr.

FIG.29Dillustrates a cross-section view of the distal balloon catheter328showing the lumen305of the distal balloon catheter328.FIG.29Eillustrates a cross-section view of the irrigation catheter308showing the lumen311of the irrigation catheter308.FIG.29Fillustrates a cross-section view of the multi-lumen tube572showing the proximal balloon lumen612and aspiration lumen610.

FIG.29Gillustrates example dimensions for the heated element304(e.g., crossing element), distal balloon320, proximal balloon322, and irrigation catheter308. The example dimensions throughout this disclosure are exemplary and should not be considered limiting.

FIG.30Aillustrates the irrigation catheter308outside of the multi-lumen tube572with the irrigation catheter hub584coupled to the Y connector586by way of the connector596. The irrigation catheter308can be varying lengths to reach different locations. The one or more apertures324can be disposed at a distal portion (e.g., distal end) of the irrigation catheter308. The one or more apertures324can be formed with a variety of techniques, which can at least include laser-cutting or punching.FIG.30Billustrates the irrigation catheter308with the irrigation catheter hub584decoupled from the Y connector586.FIG.30Cillustrates a cross-section view of the irrigation catheter308.

FIG.31Aillustrates the distal balloon catheter328outside of the multi-lumen tube572with the distal balloon catheter hub598coupled to the Y connector606by way of the connector602. The distal balloon catheter328can be varying lengths to reach different locations.FIG.31Billustrates the distal balloon catheter328with the distal balloon catheter hub598decoupled from the Y connector606. As shown, the heated element304can include wiring616extending through the distal balloon catheter328to the heated element304. For example, the wires616can extend through the lumen305of the distal balloon catheter328. The wires616can direct current to the heated element304to adjust the temperature of the heated element304(e.g., heat). The wires616can exit the distal balloon catheter328distal of the distal balloon catheter hub598.

FIG.32Aillustrates the distal balloon catheter328outside of the multi-lumen tube572. As shown, the distal balloon catheter328can include an aperture618(e.g., opening, cutout, hole) through which gas and/or fluid can flow to inflate or deflate the distal balloon320. The aperture618can open into the distal balloon320. The aperture618can provide access into the lumen305, as shown in the cross section of the distal balloon catheter328inFIG.32B, through which the gas and/or fluid can flow.FIG.32Cillustrates a member620(e.g., cylinder, rod, shaft) with the heated element304disposed on a distal end thereof. The member620can be disposed in the lumen305of the distal balloon catheter328. The member620can plug the distal end of the lumen305of the distal balloon catheter328, which can impede escape of the gas and/or fluid used to inflate or deflate the distal balloon320. The member620can be translated (e.g., slid) distally and/or proximally to deploy and/or stow the member620and heated element304. For example, the member620can be translated distally to position the heated element304outside of the lumen305of the distal balloon catheter328. The heated element304can be heated by at least the techniques described herein. For example, current can be applied to the heated element304by way of the wires616. The distal balloon catheter328with the heated element304exposed can be advanced to penetrate and/or crossover an occlusion. The heated element304(e.g., member620and heated element304) can be retracted into the lumen305of the distal balloon catheter328. In some variants, the member620can be at a fixed position relative to the distal balloon catheter328, which can include a fixed position with the member620protruding from the lumen305of the distal balloon catheter328to expose the heated element304. The member620can be various sizes, which can at least include less than 5 Fr (e.g., 1.5 millimeters), about 5 Fr (e.g., 1.5 millimeters), or more than 5 Fr (e.g., 1.5 millimeters).

FIG.33Aillustrates a cross-section view of the multi-lumen tube572, Y connector574, connector594, Y connector580, linear actuator590, irrigation catheter308, and distal balloon catheter328.FIG.33Billustrates a cross-section view of the multi-lumen tube572to show the proximal balloon lumen612and aspiration lumen610.FIG.33Cillustrates a cross-section view of the Y connector580, linear actuator590, irrigation catheter hub584, connector596, Y connector586, linear actuator592, distal balloon catheter hub598, syringe600, irrigation catheter308, and distal balloon catheter328.

In use, a guidewire614can be navigated to proximal of an occlusion (e.g., thrombus and/or plaque), which can be partial or complete. The multi-lumen tube572can be advanced over the guidewire614to proximal of the occlusion with the guidewire614disposed through the aspiration lumen610. The irrigation catheter308can be advanced in the aspiration lumen610over the guidewire614to proximal of the occlusion. The guidewire614can be removed. The distal balloon catheter328can be advanced through the lumen311of the irrigation catheter308positioned in the aspiration lumen610of the multi-lumen tube572. In some variants, the distal balloon catheter328can be advanced through the aspiration lumen610but outside of the irrigation catheter308. In some variants, the distal balloon catheter328can be advanced through another lumen of the multi-lumen tube572. The distal balloon catheter328can be advanced to a position distal of the distal end of the multi-lumen tube572. The proximal balloon322can be inflated. For example, the syringe578can urge gas and/or fluid through the proximal balloon lumen612of the multi-lumen tube572and out the aperture575into the proximal balloon322. The proximal balloon322can expand to contact the surrounding wall of the blood vessel to anchor the multi-lumen tube572in position. The heated element304can be heated, which can include applying a current to the heated element304. In some variants, the member620can be advanced to position the heated element304outside of the lumen305of the distal balloon catheter328. The heated element304can be advanced to penetrate and/or crossover the occlusion. The heat from the heated element304can ease penetration and/or crossing over, which can include softening and/or emulsifying the portions of the occlusion contacted by the heated element304. The distal balloon catheter328can be advanced with the heated element304such that the distal balloon catheter328penetrates and/or crosses over the occlusion. The temperature of the heated element304can be lowered after the occlusion has been penetrated and/or crossed. For example, the heated element304can cease being heated (e.g., no electrical current applied) after the occlusion has been penetrated and/or crossed.

The distal balloon catheter328can be advanced to position the distal balloon320distal of the occlusion. The distal balloon catheter328can be inflated. For example, the syringe600can urge gas and/or fluid through the lumen305of the distal balloon catheter328and out the aperture618into the distal balloon320. The distal balloon320can expand to contact the surrounding wall of the blood vessel. The expanded distal balloon320and proximal balloon322can isolate (e.g., fluidically isolate) the segment of the blood vessel between the distal balloon320and proximal balloon322.

The irrigation catheter308can be advanced to position the one or more apertures324at the occlusion. Heated fluid can be delivered to the occlusion by way of the one or more apertures324and/or an open distal end of the irrigation catheter308. For example, a heated fluid, which can be from a reservoir, can be introduced through the irrigation port588of the Y connector586into the irrigation catheter308. The heated fluid can soften and/or emulsify the occlusion. The fluid can be delivered to the occlusion at least at the temperatures described herein. The temperature, flow rate, pressure, and/or other characteristics of the fluid can be altered, which can include being altered based on conditions (e.g., temperature, pressure, etc.) in the blood vessel, at the occlusion, and/or within any of the components of the thermal system570. The heated fluid can be pumped through the irrigation catheter308with one or more pumps.

The aspiration lumen610of the multi-lumen tube572can aspirate the softened and/or emulsified occlusion, heated fluid, and/or other material. The rate of aspiration through the aspiration lumen610can be altered, which can include being altered based on conditions (e.g., temperature, pressure, flow rate, etc.) in the blood vessel, at the occlusion, within the aspiration lumen610, and/or any component of the thermal system570. The thermal system570can include one or more sensors (e.g., temperature sensor, pressure sensor, flow rate sensor, etc.) to sense conditions in the blood vessel, at the occlusion, and/or within any component of the thermal system570. The aspirated matter can flow through the aspiration lumen610and out the aspiration port582of the Y connector580. The aspirated matter can flow into a tank or the like. The aspirated matter can be pumped through the aspiration lumen610with one or more pumps for removal. In some variants, the thermal system570can include a separate aspiration catheter that can be advanced through a lumen of the multi-lumen tube572.

With irrigation and/or aspiration stopped (e.g., when the occlusion is removed), the distal balloon320and proximal balloon322can be deflated. For example, the gas and/or fluid in the distal balloon320and/or proximal balloon322can be removed. For example, the syringe578can urge gas and/or fluid in the proximal balloon322through the aperture575into the proximal balloon lumen612and out the port576of the Y connector574back into the syringe578. The syringe600can urge gas and/or fluid in the distal balloon320through the aperture618into the lumen305of the distal balloon catheter328and back into the syringe600, which can include by way of the port608of the Y connector606. The distal balloon catheter328, irrigation catheter308, and/or multi-lumen tube572can be retracted for removal. In some variants, the distal balloon catheter328and irrigation catheter308can be retracted back into the multi-lumen tube572and the distal balloon catheter328, irrigation catheter308, and multi-lumen tube572can be retracted together with the distal balloon catheter328and irrigation catheter308disposed in the multi-lumen tube572.

In some variants, the distal balloon catheter328can be positioned with the distal balloon320distal of the occlusion and/or the irrigation catheter308positioned proximal and/or at (e.g., in) the occlusion prior to positioning a distal end of the multi-lumen tube572proximal of the occlusion. In some variants, the heated element304(e.g., member620with the heated element304) can be inserted through a proximal opening of the distal balloon catheter328, which can include the distal balloon catheter hub598, and advanced distally out of the lumen305of the distal balloon catheter328.

In some variants, irrigation of heated fluid (e.g., a jet of heated fluid) and aspiration can be used to penetrate and/or crossover an occlusion (e.g., thrombus and/or plaque), which can replace or be used in conjunction with the heated element304. In some variants, irrigation of heated fluid (e.g., a jet of heated fluid) and aspiration can be used to soften and/or emulsify an occlusion for removal by way of aspiration. In some variants, irrigation of heated fluid (e.g., a jet of heated fluid) can be used to soften and/or emulsify an occlusion, which may not include aspiration.FIG.34Aillustrates an example irrigation catheter624and aspiration catheter622, which can be used to penetrate and/or crossover an occlusion and/or soften and/or emulsify an occlusion for aspiration. As shown, the irrigation catheter624can include a curve127(e.g., bend, hook, turn) such that an opening625(e.g., open end, open distal end) faces in a proximal direction. The irrigation catheter624can extend distally and curve proximally at the curve127to face the opening625in the proximal direction. The aspiration catheter622can include an opening (e.g., open end, open distal end) that faces in the distal direction. The opening625of the irrigation catheter624can face toward the opening623of the aspiration catheter622. The central axis of the opening625of the irrigation catheter624can extend through the opening623of the aspiration catheter622. In use, the irrigation catheter624and the aspiration catheter622can be navigated to proximal of an occlusion using at least the techniques described herein. Heated fluid can flow through the irrigation catheter624and out the opening625. The irrigation catheter624can be advanced to penetrate and/or crossover the occlusion. The heated fluid can ease penetration and/or crossover, which can include softening and/or emulsifying the occlusion. The aspiration catheter622can be advanced with the irrigation catheter624to maintain a gap within a range between the opening625and the opening623. In some variants, the irrigation catheter624and aspiration catheter622can be fixed together to maintain a relative positioning. The aspiration catheter622can aspirate heated fluid, softened and/or emulsified occlusion, and/or other material. With the opening625facing the opening623, the heat from the heated fluid can be localized. In some variants, the irrigation catheter624and/or aspiration catheter622can be used to remove the occlusion, which can be in addition to penetrating and/or crossing.

FIGS.34B and34Cillustrate an irrigation device628(e.g., irrigation catheter) that can be used to penetrate and/or crossover an occlusion (e.g., thrombus and/or plaque) and/or soften and/or emulsify the occlusion for removal. The irrigation device628can include a closed distal end632, which can include a flat outer surface (e.g., include a flat surface that is perpendicular to the axis of the irrigation device628) and/or a curved inner surface634. The irrigation device628can include one or more openings630(e.g., apertures), such as one, two, three, four, five, six or more. The one or more openings630can be disposed in the peripheral wall of the irrigation device628that defines an internal lumen. The one or more openings630can be disposed circumferentially about an axis of the irrigation device628(e.g., axis of the internal lumen). The one or more openings630can be disposed proximate the distal end632. The heated fluid can flow distally through the internal lumen and out the one or more openings630to the occlusion. The heated fluid can flow distally through the internal lumen to the closed distal end632and be deflected by the curved surface634and out the one or more openings630to the occlusion. The one or more openings630can be various sizes and/or shapes. The one or more openings630can be elongate in the longitudinal direction of the irrigation device628. The irrigation device628can be deployed from inside of an aspiration device626(e.g., aspiration catheter). For example, the irrigation device628can be advanced distally through an opening of the aspiration device626. The irrigation device628can soften and/or emulsify the occlusion with heated fluid flowing through the one or more openings apertures630to facilitate penetration and/or crossover and/or softening and/or emulsification for removal by way of aspiration. The aspiration device626can aspirate the heated fluid, softened and/or emulsified lens, and/or other matter through the opening of the aspiration device626for removal. The aspiration device626can have a lower pressure inside that sucks the heated fluid, softened and/or emulsified lens, and/or other matter through the opening of the aspiration device626for removal. The low pressure inside the aspiration device626can localize the impact of the heated fluid. The irrigation device628and/or aspiration device626can be used to remove the occlusion, which can be in addition to penetrating and/or crossing.

FIG.35Aillustrates a fluid jet system636(e.g., thermal penetration system, thermal crossover system, thermal system, thermal fluid system) that can be used to penetrate, crossover, and/or remove an occlusion (e.g., thrombus and/or plaque). The fluid jet system636, in some variants, can break up (e.g., fragment) an occlusion with a jet (e.g., stream) of fluid (e.g., heated fluid). The use of heated fluid can soften and/or emulsify the occlusion, which can ease fragmentation. The fluid jet system636can include a fluid jet catheter652with a distal end654(e.g., open end, open distal end, opening, nozzle, outlet, etc.). The distal end654can be navigated to proximal of an occlusion. The fluid jet catheter652can have a balloon656that can be expanded and deflated. When expanded, the balloon656can contact the surrounding wall of the blood vessel to impede flow. The fluid jet catheter652can be coupled with a pump640(e.g., DC pump). The pump640can be coupled with a control device638to control the pump640, which can include powering the pump. The pump640can pump fluid from a tank642(e.g., reservoir, bag, bottle, container, syringe, chamber, vessel, compartment, etc.) through an inlet644and into the fluid jet catheter652by way of an outlet646. The fluid, in some variants, can be heated in the tank642. The fluid jet catheter652can be coupled to the outlet646of the pump640with a Y connector648. The Y connector648can include a port650. In some variants, matter (e.g., heated fluid, softened and/or emulsified occlusion, and/or other material) can be aspirated through the fluid jet catheter652and out the port650of the Y connector648. For example, a pump and/or vacuum source can be fluidically coupled to the port650to urge matter (e.g., heated fluid, softened and/or emulsified occlusion, and/or other material) out by way of the port650. The fluid jet catheter652can include one or more openings to facilitate aspiration. In some variants, the distal end654can include an opening for aspiration. In some variants, heated fluid can flow out of the distal end654and then matter can be aspirated through the distal end654. In some variants, an aspiration device can be introduced to aspirate matter. In some variants, matter is not aspirated. In some variants, the balloon656is not included.

FIG.35Billustrates a fluid jet658(e.g., stream) flowing at thrombus108for fragmentation, which can include softening and/or emulsification. The fluid jet658can be heated. The temperature, flow rate, size of the opening at the distal end654, distance to the thrombus108, flux, pressure, duration the fluid jet system636directs the fluid jet658at the occlusion (e.g., thrombus108), and/or other characteristics can be adjusted. The foregoing characteristics can be adjusted based on sensed conditions in the blood vessel (e.g., vein104), conditions at the occlusion (e.g., thrombus108), characteristics of the occlusion (e.g., thrombus108), and/or conditions within the fluid jet system636. For example, the foregoing characteristics can be adjusted at least based on a temperature at the distal end654, mass of the thrombus108, density of the thrombus108, and/or length of the thrombus108. In some variants, the heated fluid, fragmented occlusion, softened occlusion, and/or emulsified occlusion may not be aspirated.

FIG.35Cillustrates an aspiration device660(e.g., aspiration catheter) aspirating the fragmented thrombus108(e.g., softened and/or emulsified thrombus108) and/or heated fluid through an opening662(e.g., open distal end). The aspirated matter can flow into a tank661(e.g., reservoir, bag, bottle, container, syringe, chamber, vessel, compartment, etc.). In some variants, the aspiration catheter660can aspirate matter while the fluid jet catheter652directs the fluid jet658at the thrombus108. In some variants, the aspiration catheter660can aspirate matter after the fluid jet catheter652directs the fluid jet658at the thrombus108. In some variants, the fluid jet catheter652can be deployed through the aspiration catheter660. In some variants, the aspiration catheter660can be deployed through the fluid jet catheter652. In some variants, the aspiration catheter660can be disposed on an opposite side of the thrombus108as the fluid jet catheter652. The vacuum force (e.g., sucking force) of the aspiration catheter660can be adjusted, which can include being adjusted based on the conditions and/or characteristics described herein. The size of the opening662can be adjusted, which can include being adjusted based on the conditions and/or characteristics described herein.

FIG.35Dillustrates the fluid jet catheter652disposed on one side (e.g., proximal side) of the thrombus108to emit a fluid jet to break up (e.g., fragment), which can include soften and/or emulsify, the thrombus108. In some variants, a second fluid jet catheter660can be disposed on an opposite side of the thrombus108(e.g., distal side of the thrombus108). The second fluid jet catheter660can be oriented to face in a proximal direction. The second fluid jet catheter660can include a balloon664that can be inflated and/or deflated. With the balloon656and balloon664inflated, the segment of the blood vessel (e.g., vein104) between the balloon656and balloon664can be isolated (e.g., fluidically isolated) from the remainder of the blood vessel. In some variants, the fluid jet catheter652can direct a fluid jet, which can be heated, out of the distal end654to the thrombus108. The fluid jet can break up, soften, and/or emulsify the thrombus108. In some variants, the second fluid jet catheter660can direct a fluid jet, which can be heated, out of the distal end654to the thrombus108. In some variants, no aspiration is performed. In some variants, one of or both the catheter652and the catheter660can direct a fluid jet at the thrombus108for breakup (e.g., fragmentation), softening, and/or emulsification. In some variants, one or both the catheter652and the catheter660can aspirate heated fluid, fragmented thrombus, softened thrombus, and/or emulsified thrombus. As illustrated inFIG.35E, the fluid jet system636can include temperature sensors to sense temperatures in the blood vessel (e.g., vein104), outside the blood vessel, and/or in the fluid jet system636. For example, the fluid jet system636can include a temperature sensor666in the blood vessel, which can include being at the occlusion. The fluid jet system636can include a temperature sensor668outside the blood vessel. The fluid jet system636can adjust the fluid jet and/or aspiration based on the sensed temperatures and/or other sensed characteristics. In some variants, one fluid jet can be used. In some variants, multiple fluid jets can be used. In some variants, peripheral fluid jets can be used. In some variants, aspiration is used. In some variants, aspiration is not used. In some variants, the catheter652and/or catheter660can include a port (e.g., side port) for aspiration. In some variants, a dual cannula system can be used to facilitate irrigation and aspiration.

The catheters described herein can be cannulas, tubes, etc. In some variants, expandable devices other than balloons can be used in the system and methods described herein, which can at least include bags, umbrellas, meshes, cages, nets, etc. In some variants, the catheters described herein can be referred to as tubes and/or extrusions. In some variants, the systems and/or methods described herein can omit one or both of the proximal and distal balloons. In some variants, micromechanoaspiration and/or microthermomechanoaspiration can be used. In some variants, a reverse jet can be employed to localize emulsification. For example, concentric irrigation and aspiration catheters can be used with the aspiration catheter having a low pressure to suck in the heated fluid, which can localize the softening and/or emulsification zone. In some variants, the aspiration catheter can be disposed proximate an opening of the irrigation catheter such that the low pressure in the aspiration catheter can suck in the heated fluid, which can localize the softening and/or emulsification zone.

In some variants, cutting tools (e.g., mechanical cutting tools, scraping devices, slicing devices), which may at least include a brush, wire brush, wire, coil, lasso, corkscrew, drill, wire, spatula, auger, tapered wire drill, blade, knife, constricting coil, vitrectomy probe, ultrasonic cutter, extendable scrubbers (e.g., wires), umbrella, inverted mesh, and/or others, can be used with any of the systems and/or methods described herein. The cutting tools, in some variants, can include heated elements to soften and/or emulsify an occlusion. In some variants, the irrigation devices and/or aspiration devices (e.g., catheters) described herein can include features (e.g., flanges, fins, coils, protrusions, cutting edges, projections, blades, etc.) to mechanically break up (e.g., fragment) an occlusion. In some variants, the features can include heated elements. For example, the irrigation catheters described herein can include a protrusion disposed on a distal end thereof. The irrigation catheter can be rotated and/or translated such that the protrusion cuts into an occlusion to fragment the occlusion. The protrusion can include a heated element to soften and/or emulsify the occlusion. A wire (e.g., single or multiple) can be deployed to help with mechanical breakup of an occlusion (e.g., chronic occlusion). For example, the wire can be deployed to engage with an occlusion disposed between two inflated balloons. The wire can be moved to break up the occlusion, which can be performed simultaneously with irrigation with the heated fluid. The cutting tools can be made of a variety of materials such as polymers, metals, metal alloys, ceramics, and/or others. The cutting tools can be rotated, advanced distally, and/or retracted proximally to break up (e.g., fragment) an occlusion. The cutting tools can be disposed on the irrigation device, aspiration device, crossing device, a separate device, and/or other devices, which can include being disposed at an end (e.g., distal portion, middle portion, and/or proximal portion). The cutting tools, such as a brush (e.g., wire brush) can be disposed throughout a device. The cutting tools can be a partial brush, flared brush, and/or variable diameter brush.

In some variants, the aspiration devices (e.g., catheters) described herein can include a dual port luer hub. In some variants, the aspiration devices (e.g., catheters) described herein can include a single port luer hub. In some variants, the irrigation devices (e.g., catheters) described herein can include a single port luer hub. In some variants, the crossing devices (e.g., distal balloon catheters, crossing catheters) described herein can include a single port luer hub.

In some variants, the irrigation devices (e.g., irrigation catheters) can include one or more heated elements (e.g., ring(s), spot(s), wire(s), etc.) that can interface with the occlusion to soften and/or emulsify the occlusion. In some variants, the aspiration devices (e.g., aspiration catheters) can include a heated mouth (e.g., heated opening), which can include one or more ring(s), spot(s), wire(s), etc. The heated mouth can soften and/or emulsify the occlusion, which can include easing separation of the occlusion from the wall of the blood vessel, for aspiration. The heated mouth of the aspiration device can be advanced to interface the occlusion. The heated mouth can be used simultaneously and/or separately (e.g., after) irrigation with the heated fluid (e.g., fluid jet). In some variants, the aspiration devices described herein can be advanced with the irrigation devices. In some variants, the aspiration devices described herein can be advanced while aspirating.

In some variants, the fluid jets described herein can be used in conjunction with a heated element for crossing and/or penetration. In some variants, closed-loop techniques and/or artificial intelligence can control (e.g., modulate) the heat (e.g., current), flow rates, pressures, etc. applied by the systems described herein. In some variants, the detection of the type of material, thrombus, plaque, and/or occlusion being removed can be detected (e.g., remotely detected) through data, which can include using closed-loop techniques and/or artificial intelligence. In some variants, the systems and/or methods described herein can monitor a quantity of occlusion collected.

In some variants, the systems and methods described herein can include using a medicament, such as a healing agent (e.g., lytics), anti-inflammatory, and/or endothelial promoting (e.g., hormones) medicament.

In some variants, the systems and methods described herein can be used in a neuro environment.

The system and methods described herein can obtain vascular access using percutaneous techniques. A guidewire can be advanced through the blood vessel system (e.g., venous system or arterial system) to an occlusion site, which can be under fluoroscopic guidance. The system and methods described herein can use fluoroscopic guidance. A catheter system of the thermal systems described herein can be guided over the guidewire. The guidewire can be removed. A fluid delivery system can be coupled to an irrigation catheter. A heated fluid can be infused through the irrigation catheter, which can include at a controlled rate and/or temperature. The temperature and flow rate of the heated fluid can be monitored and adjusted. The heated fluid, softened and/or emulsified occlusion (e.g., thrombus and/or plaque), and/or other matter can be aspirated, which can include being aspirated into a waste reservoir. Angiographic imaging and/or ultrasound can be used to monitor a status of the occlusion. The catheter system can be removed. The vascular access can be closed using standard techniques.

In some variants, a patient may be prescribed medicaments, such as antiplatelet or anticoagulants, to prevent formation of new thrombi and/or plaque.

For non-calcified plaque, the root mean-squared error (RMSE) of the image-based decomposition was estimated to be 0.7%, 1.5%, and 0.3% for water, lipid, and protein contents, respectively. As for the calcified plaques, the RMSE of the 5 mm plaques were estimated to be 5.6%, 5.7%, 0.2%, and 3.1%, for water, lipid, calcium, and protein contents, respectively.

Terminology

Although the systems and methods have been disclosed in the context of certain 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 other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof. For example, occlusions are referenced herein. Occlusion can refer to partial and/or complete occlusions. Occlusions can refer to occlusions in an artery and/or vein. Occlusions can refer to a thrombus (e.g., clot), which can include acute and/or chronic. Occlusions can refer to plaque. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes. The scope of this disclosure should not be limited by the particular disclosed embodiments described herein.

Methods of using the foregoing system(s) (including device(s), apparatus(es), assembly (ies), structure(s) or the like) are included; the methods of use can include using or assembling any one or more of the features disclosed herein to achieve functions and/or features of the system(s) as discussed in this disclosure. Methods of manufacturing the foregoing system(s) are included; the methods of manufacture can include providing, making, connecting, assembling, and/or installing any one or more of the features of the system(s) disclosed herein to achieve functions and/or features of the system(s) as discussed in this disclosure.

Some embodiments have been described in connection with the accompanying drawings. Components can be added, removed, and/or rearranged. Orientation references such as, for example, “top” and “bottom” are for ease of ease of discussion and may be rearranged such that top features are proximate the bottom and bottom features are proximate the top. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.

In summary, various embodiments and examples of juicing devices and methods have been disclosed. Although 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 this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or other uses of the embodiments, as well as to certain modifications and equivalents thereof. This disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another. Accordingly, the scope of this disclosure should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.