Patent Application
20240252223
This disclosure relates to thrombectomy systems and methods.
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.
Thrombi can be removed by way of a thrombectomy procedure. A thrombectomy procedure may include navigating a guide wire 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 guide wire 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. Accordingly, thrombectomy solutions to reduce the number of passes to remove a thrombus are needed.
A thrombus can include fibrin, red blood cells, platelets, leukocytes, and neutrophil extracellular traps. 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 guide wires, catheters, and/or expandable devices to pass through the thrombus. Attempting to pass through a hardened thrombus can be time consuming, frustrating, and/or result in damage to the vessel wall and/or valves.
The thermal thrombectomy systems and methods disclosed herein may at least address the problems indicated above. A thrombus (e.g., one or more proteins and/or biopolymers) may be softened and/or emulsified (e.g., melted, liquefied) by the thermal thrombectomy systems and methods disclosed herein. The softening and/or emulsification of the thrombus can ease penetration with a wire, guide wire, catheter, cutting device, and/or collection device (e.g., expandable device, capture device). The softening or emulsification of the thrombus can enable the thrombus to separate from the vessel walls and endothelial cellular layers more easily. The softening and/or emulsification of the thrombus may help break the thrombus down into fragments more easily extracted with an expandable capture device, such as a balloon, umbrella, basket, bag, scoop, etc., and/or aspiration device. The softening and/or emulsification of the thrombus may enable an expandable device (e.g., capture device) and/or aspiration device to extract the thrombus with a single pass or fewer passes, to facilitate a more efficient and convenient procedure as well as reducing the risk of damage to vessel walls, vessel valves, vessel inflammation, and re-thrombosis. The thermal thrombectomy systems described herein may be used to remove both acute and chronic thrombi in both veins and arteries. For example, the thermal thrombectomy system and methods described herein can insert (e.g., inject) a heated element into a chronic region of a thrombus, which can emulsify the chronic region and/or loosen up the chronic region. The thermal thrombectomy systems and methods disclosed herein may facilitate local removal of thrombi, which may preserve endothelial cells and valves. The thermal thrombectomy systems and methods disclosed herein may remove both chronic and acute thrombi. The thermal thrombectomy systems and methods disclosed herein may access all anatomical blood vessel locations (e.g., below knee and smaller vessels). The thermal thrombectomy systems and methods disclosed herein may reduce blood loss. The thermal thrombectomy systems and methods disclosed herein may avoid systemic thrombolytics. The thermal thrombectomy systems disclosed herein may be disposable (e.g., no console) or reusable.
In some variants, the thermal thrombectomy systems disclosed herein can include a heated wire (e.g., heated element, heated guide wire), which may also be referred to as a temperature controlled wire (e.g., temperature controlled element, temperature controlled guide wire). The heated wire may 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, hot liquid, nuclear, and/or others. A distal portion of the heated wire may be configured to be disposed at a thrombus to apply heat to the thrombus to soften and/or emulsify the thrombus forming elements thereof. A proximal portion (e.g., the portion configured to be disposed away from the thrombus) may be insulated. The heated wire can be navigated to the thrombus, heated to a temperature sufficient to liquefy or at least soften the thrombus, inserted into thrombus, and advanced through the thrombus to a distal position. Advancing through the thrombus with a heated wire may ease penetration compared to an unheated wire. In some variants, the wire may penetrate the thrombus, which may include passing through to the distal position, prior to heating. In some variants, an expandable device, which may also be heated, can be positioned distal of the thrombus prior to heating of the wire.
In some variants, the thermal thrombectomy systems disclosed herein may include an expandable device (e.g., capture device), which may at least include a bag (e.g., mesh, braded, etc.), inverted mesh, mesh, stent, umbrella, balloon, basket, funnel (e.g., mesh funnel), disc, and/or other device. The expandable device may be advanced along a guide wire, which may be a heated guide wire, to a position distal of the thrombus and deployed (e.g., expanded) to impede fragments, such as emboli, of the thrombus from travelling through the blood stream to other regions of the body, such as the lungs. The expandable device may be advanced along a guide wire, which may be a heated guide wire, to a position proximal of the thrombus and deployed (e.g., expanded) to impede fragments, such as emboli, of the thrombus from travelling through the blood stream to other regions of the body. In some variants, the expandable device may be heated, which may include having some portions heated and other portions not heated. For example, a distal portion of the expandable device, or a catheter delivering the expandable device, may be heated to facilitate passing through the thrombus. The expandable device, if heated, can be heated using at least the techniques described herein. The expandable device can be deployed by way of a catheter positioned distal of the thrombus and/or other occlusion, which can be after emulsification the heated guide wire is removed.
In some variants, the thermal thrombectomy systems disclosed herein may include a cutting device (e.g., thermal device), which may at least include a coil, lasso, corkscrew, drill, wire, spatula, auger, tapered wire drill, blade, knife, constricting coil, virectomy probe, ultrasonic cutter, extendable scrubbers (e.g., wires), umbrella, inverted mesh, and/or others. The cutting device, which may also be referred to as a scraping device and/or slicing device, may be advanced along the guide wire, which may be a heated guide wire, to the thrombus. In some variants, the cutting device may be deployed by way of a catheter positioned distal of the thrombus and/or other occlusion, which can be after the heated wire is removed. The cutting device may be manipulated to break up the thrombus. For example, the cutting device may be rotated, moved distally, moved proximally, vibrate, and/or otherwise manipulated. The cutting device may include mechanical, electrical, thermal, light-based, ultrasound, and/or other features. In some variants, the wire, which may be a heated guide wire, can include any of the foregoing features (e.g., coil, corkscrew, drill, wire, spatula, auger, tapered wire drill, etc.). The cutting device may be heated, which may include having a heated portion and an unheated portion, to facilitate breaking up the thrombus. In some variants, the cutting device can be used without an expandable device and/or separate guide wire. In some variants, the cutting device may have an oscillator and/or reciprocator to further ease the cutting or separation of the desired tissue.
In some variants, the thermal thrombectomy systems disclosed herein may include an aspiration device, which may at least include a wall vacuum, venturi vacuum, auger, syringe, oscillating vacuum with return filter, and/or other features. In some variants, the aspiration device may aspirate the thrombus out of the blood vessel. In some variants, the aspiration device may be heated, which may include having a heated portion and an unheated portion. For example, the aspiration device may include a mouth that can be heated. In some variants, a heated mouth of an aspiration device can be advanced distally to emulsify and aspirate a thrombus and/or other occlusion.
In some aspects, the techniques described herein relate to a thermal device configured to apply heat to a thrombus, the thermal device including: an outer tube including a distal portion; a heated element disposed at the distal portion of the outer tube; and one or more conduits configured to apply an electrical current to the heated element to raise a temperature of the heated element to apply heat to a thrombus.
In some aspects, the techniques described herein relate to a thermal device, further including an inner tube disposed within the outer tube that is configured to receive a guide wire, wherein the thermal device is configured to be advanced over the guide wire.
In some aspects, the techniques described herein relate to a thermal device, wherein the heated element includes a loop.
In some aspects, the techniques described herein relate to a thermal device, wherein the loop includes a nickel titanium alloy.
In some aspects, the techniques described herein relate to a thermal device, wherein the loop includes a tube.
In some aspects, the techniques described herein relate to a thermal device, wherein the loop includes a hollow lumen, and the thermal device further including a temperature sensor disposed within the hollow lumen.
In some aspects, the techniques described herein relate to a thermal device, further including a controller configured to modulate the electrical current applied to the heated element based on a sensed temperature by the temperature sensor.
In some aspects, the techniques described herein relate to a thermal device, further including a temperature sensor.
In some aspects, the techniques described herein relate to a thermal device, further including an electrode to sense leaked current.
In some aspects, the techniques described herein relate to a thermal device, wherein the electrode is a marker for visualization.
In some aspects, the techniques described herein relate to a thermal device, further including an expandable device configured to be expanded proximally of the thrombus.
In some aspects, the techniques described herein relate to a thermal device, wherein the expandable device includes a balloon.
In some aspects, the techniques described herein relate to a thermal device, wherein the expandable device includes a lumen through which the outer tube is configured to be advanced.
In some aspects, the techniques described herein relate to a thermal thrombectomy device configured to apply heat to a thrombus, the thermal thrombectomy device including: an expandable assembly including an expandable device, the expandable device configured to be expanded proximally of a thrombus; and a thermal assembly including a heated element, the thermal assembly configured to be advanced distally over a guide wire and out of the expandable assembly to apply heat to the thrombus with the heated element.
In some aspects, the techniques described herein relate to the thermal thrombectomy device, wherein the thermal assembly further includes one or more conduits configured to apply an electrical current to the heated element to raise a temperature of the heated element.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, wherein the expandable device is a balloon.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, wherein the heated element includes a loop.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, wherein the loop includes a tube.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, wherein the loop includes a hollow lumen, and the thermal thrombectomy device includes a temperature sensor disposed within the hollow lumen.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, further including a controller configured to modulate the electrical current applied to the heated element based on a sensed temperature by the temperature sensor.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, further including a temperature sensor.
In some aspects, the techniques described herein relate to a thermal thrombectomy device, further including an electrode to sense leaked current.
In some aspects, the techniques described herein relate to a method of crossing a thrombus, the method including: advancing a thermal assembly over a guide wire to a thrombus; and applying an electrical current to a heated element of the thermal assembly to heat the thrombus;
In some aspects, the techniques described herein relate to a method, further including advancing an expandable device over the guide wire to proximate the thrombus and expanding the expandable device.
In some aspects, the techniques described herein relate to a method, wherein the expandable device includes a balloon.
In some variants, a thermal thrombectomy device that can apply heat to a thrombus in a blood vessel of a patient is disclosed herein. The device can include a wire. The device can include an insulation layer disposed over at least a proximal portion of the wire to protect anatomy of a patient from heat. The device can include a temperature modulation unit that can apply energy to the wire to raise a temperature of the wire. The wire can be navigated through the vasculature of the patient to apply heat to a thrombus such that the thrombus softens or emulsifies (e.g., melts).
In some variants, the wire can include a nickel and titanium alloy.
In some variants, the insulation layer maybe a sheath.
In some variants, the device may include a power source. The power source can be a battery. In some variants, the wire is a guide wire.
In some variants, energy applied by the temperature modulation unit can be electricity.
In some variants, the temperature modulation unit can raise the temperature of the wire to heat collagen of the thrombus to 60 or more degrees Celsius. In some variants, the temperature modulation unit can raise the temperature of the wire to heat collagen of the thrombus to 60 or more degrees Celsius
In some variants, the temperature modulation unit can raise the temperature of the wire to heat collagen of the thrombus to 70 degrees Celsius. In some variants, the temperature modulation unit can raise the temperature of the wire to heat collagen of the thrombus to 80 degrees Celsius.
In some variants, the temperature modulation unit can raise the temperature of the wire to 60-80 degrees Celsius. In some variants, the temperature modulation unit can raise the temperature of the wire to 60 or more degrees Celsius.
In some variants, the temperature modulation unit can raise the temperature of the wire to 70 degrees Celsius. In some variants, the temperature modulation unit can raise the temperature of the wire to 80 or more degrees Celsius.
In some variants, the wire can include a coil.
In some variants, a thermal thrombectomy system that can apply heat to a thrombus in a blood vessel of a patient is disclosed herein. The system can include a wire. The system can include a layer of material surrounding a proximal portion of the wire. The system can include a power source that can apply energy to the wire to raise a temperature of the wire. The wire can be navigated through the vasculature of a patient to apply heat to a thrombus.
In some variants, the wire can be a guide wire.
In some variants, the layer of material can be a sheath.
In some variants, the layer of material can insulate anatomy of the patient from heat of the wire.
In some variants, the wire can include a nickel and titanium alloy.
In some variants, the power source can be a battery. In some variants, the electrical insulation comprises Polytetrafluoroethylene.
In some variants, the energy applied by the power source can be electricity.
In some variants, the power source can raise the temperature of the wire to heat the thrombus to 60-200 degrees Celsius. In some variants, the power source can raise the temperature of the wire to heat the thrombus to 60-200 degrees Celsius.
In some variants, the power source can raise the temperature of the wire to heat the thrombus to 70 degrees Celsius. In some variants, the power source can raise the temperature of the wire to heat the thrombus to 80 degrees Celsius.
In some variants, the power source can raise the temperature of the wire to 60-75 degrees Celsius. In some variants, the power source can raise the temperature of the wire to 60-80 degrees Celsius. In some variants, the power source can raise the temperature of the wire to 60-120 degrees Celsius.
In some variants, the power source can raise the temperature of the wire to 70 degrees Celsius. In some variants, the power source can raise the temperature of the wire to 80 degrees Celsius
In some variants, the wire can include a coil that can be disposed within the layer of material and deployed when proximate the thrombus.
In some variants, an outer periphery of the coil can be insulated.
In some variants, the wire can include two coils that can be overlaid on each other.
In some variants, the wire can include a coil drill.
In some variants, the wire can include a lasso. In some variants, the wire can include a loop.
In some variants, the wire can include a coil and a straight portion disposed through the coil.
In some variants, the wire can include an outer coil and an inner coil that can be joined together at a distal end. The inner coil can be heated and the outer coil may not be heated.
In some variants, the wire can include an outer coil and an inner coil that can be joined together at a distal end. The outer coil can be insulated.
In some variants, a method of performing a thrombectomy is disclosed herein. The method can include navigating a wire through vasculature of a patient to a thrombus. The method can include applying an energy source to the wire to raise a temperature of the wire. The method can include advancing the wire through the thrombus.
In some variants, the method can include advancing an expandable member along the wire to distal the thrombus.
In some variants, the method can include advancing a cutting device along the guide wire and into the thrombus.
In some variants, the method can include rotating the cutting device.
In some variants, the cutting device can include an auger.
In some variants, the method can include aspirating the thrombus.
In some variants, a method of performing a thrombectomy is disclosed herein. The method can include navigating a wire in a sheath through vasculature of a patient to a thrombus. The method can include applying an energy source to the wire to raise a temperature of the wire. The method can include advancing the sheath and wire into the thrombus. The method can include unsheathing a distal portion of the wire to allow the wire to self-expand. The method can include retracting the wire.
In some variants, wherein the wire self-expands to a coil and the method can include rotating the coil.
In some variants, the method can include aspirating the thrombus.
In some variants, a method of performing a thrombectomy is disclosed herein. The method can include navigating a wire in a sheath through vasculature of a patient to a thrombus. The method can include applying an energy source to the wire to raise a temperature of the wire. The method can include unsheathing a distal portion of the wire to allow the wire to self-expand. The method can include advancing the wire into the thrombus. The method can include retracting the wire.
In some variants, wherein the wire self-expands to a coil and the method can include rotating the coil.
In some variants, the method can include aspirating the thrombus.
In some variants, a thermal thrombectomy device is disclosed herein. The device can include a catheter that can include a port and a mount. The device can include a wire extending through the port. The wire can include an internal portion inside the catheter and external portion forming a lasso disposed outside the catheter. The end of the external portion can be coupled to the mount. The device can include a power source that can apply an electrical current to electrical contacts disposed at the port and mount to raise a temperature of the wire to soften or emulsify (e.g., melt) a thrombus. The device can include a cable extending through the catheter. The internal portion of the wire can be coupled to the cable. The cable can be rotated to extend more of the wire outside the catheter to increase a diameter of the lasso.
In some variants, the techniques described herein relate to a thermal thrombectomy system configured to remove a thrombus from a blood vessel of a patient, the system including: a capture device including a bag and a loop at an opening into the bag that is configured to be heated to apply heat to a thrombus, wherein the capture device is configured to be retracted proximally to interface the loop with the thrombus to detach the thrombus from a wall of a blood vessel, and wherein the bag is configured to catch the detached thrombus.
In some variants, the techniques described herein relate to a system, further including a catheter, wherein the capture device is configured to be deployed distally relative to the thrombus through the catheter.
In some variants, the techniques described herein relate to a system, further including a heated wire, the heated wire configured to penetrate the thrombus to facilitate distally positioning the capture device relative to the thrombus.
In some variants, the techniques described herein relate to a system, wherein further including an expandable device with a balloon configured to be inflated proximally of the thrombus.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-200 degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is about 80 or more degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-80 degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-70 degrees Celsius.
In some variants, the techniques described herein relate to a system, further including a sheath configured to be disposed over the capture device.
In some variants, the techniques described herein relate to a system, wherein the loop includes a diameter that is larger than a diameter of a blood vessel.
In some variants, the techniques described herein relate to a system, further including an aspiration device configured to aspirate the thrombus.
In some variants, the techniques described herein relate to a system, wherein the aspiration device includes a mouth that is configured to be heated.
In some variants, the techniques described herein relate to a system, further including a temperature sensor configured to sense a temperature in the blood vessel.
In some variants, the techniques described herein relate to a system, wherein the system is configured to control the temperature of the loop based on the sensed temperature in the blood vessel.
In some variants, the techniques described herein relate to a method of performing a thrombectomy, the method including: positioning a capture device distal of a thrombus in a blood vessel; expanding a bag of the capture device; heating a loop disposed at a proximal opening into the bag to a temperature; proximally retracting the capture device to interface the loop with the thrombus to detach the thrombus from a wall of the blood vessel; catching the thrombus in the bag; and proximally retracting the capture device with the thrombus in the bag to remove the thrombus from the patient.
In some variants, the techniques described herein relate to a method, further including penetrating the thrombus with a heated wire.
In some variants, the techniques described herein relate to a method, wherein the temperature is between 60-200 degrees Celsius.
In some variants, the techniques described herein relate to a method, wherein the temperature is 80 or more degrees Celsius.
In some variants, the techniques described herein relate to a method, wherein the temperature is between 60-80 degrees Celsius.
In some variants, the techniques described herein relate to a method, wherein the temperature is between 60-70 degrees Celsius.
In some variants, the techniques described herein relate to a method, further including aspirating the thrombus with an aspiration device.
In some variants, the techniques described herein relate to a method, further including heating a mouth of the aspiration device.
In some variants, the techniques described herein relate to a method, further including sensing a temperature in the blood vessel and controlling the temperature of the loop based on the sensed temperature.
In some variants, the techniques described herein relate to a thermal thrombectomy system configured to remove a thrombus from a blood vessel of a patient, the system including: an aspiration device including a mouth that is configured to be heated to a temperature to soften or emulsify a thrombus, wherein the aspiration device is configured to be advanced distally to interface with and aspirate a thrombus.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-200 degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is about 80 or more degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-80 degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-70 degrees Celsius.
In some variants, the techniques described herein relate to a thermal thrombectomy system configured to remove a thrombus from a blood vessel of a patient, the system including: a capture device including a bag; and a cutting device including a loop configured to be heated to a temperature to soften or emulsify a thrombus in a blood vessel; wherein the capture device and the cutting device are configured to be positioned distally of the thrombus and retracted proximally to interface the loop with the thrombus to detach the thrombus from the wall of the blood vessel and capture the detached thrombus in the bag.
In some variants, the techniques described herein relate to a system, further including a catheter, wherein the capture device and cutting device are configured to be deployed distally relative to the thrombus through the catheter.
In some variants, the techniques described herein relate to a system, further including a heated wire, the heated wire configured to penetrate the thrombus to facilitate distally positioning the capture device relative to the thrombus.
In some variants, the techniques described herein relate to a system, wherein a distal end of the capture device or a distal end of the cutting device includes a heated element configured to penetrate the thrombus to facilitate distally positioning the capture device and cutting device relative to the thrombus.
In some variants, the techniques described herein relate to a system, wherein the bag comprises a mesh.
In some variants, the techniques described herein relate to a system, wherein the temperature is 80 or more degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-80 degrees Celsius.
In some variants, the techniques described herein relate to a system, wherein the temperature is between 60-70 degrees Celsius.
In some variants, the techniques described herein relate to a system, further including a sheath configured to be disposed over the capture device.
In some variants, the techniques described herein relate to a system, further including a temperature sensor configured to sense a temperature in the blood vessel, wherein the system is configured to control the temperature of the loop based on the sensed temperature in the blood vessel.
In some variants, the techniques described herein relate to a system, wherein the capture device and cutting device are coupled together.
In some variants, the techniques described herein relate to a system, wherein an extension boom extends from a proximal opening into the bag to a distal end of the bag.
In some variants, the techniques described herein relate to a method of performing a thrombectomy, the method including: positioning a capture device and a cutting device distal of a thrombus in a blood vessel; expanding a bag of the capture device; heating a loop of the cutting device to a temperature; proximally retracting the cutting device to interface the loop with the thrombus to detach the thrombus from a wall of the blood vessel; catching the thrombus in the bag; and proximally retracting the cutting device and capture device with the thrombus in the bag to remove the thrombus from the patient.
In some variants, the techniques described herein relate to a method, further including penetrating the thrombus with a heated wire.
In some variants, the techniques described herein relate to a method, wherein the temperature is between 60-200 degrees Celsius.
In some variants, the techniques described herein relate to a method, wherein the temperature is about 80 or more degrees Celsius.
In some variants, the techniques described herein relate to a method, wherein the temperature is between 60-80 degrees Celsius.
In some variants, the techniques described herein relate to a method, wherein the temperature is between 60-70 degrees Celsius.
In some variants, the techniques described herein relate to a method, further including aspirating the thrombus with an aspiration device.
In some variants, the techniques described herein relate to a method, further including heating a mouth of the aspiration device.
In some variants, the techniques described herein relate to a method, further including sensing a temperature in the blood vessel and controlling the temperature of the loop based on the sensed temperature.
In some variants, the techniques described herein relate to a thrombectomy system including: a recessed surface that is configured to be deployed to engage a thrombus; and a conduit configured to provide energy to the recessed surface to heat the recessed surface to a temperature to soften or emulsify the thrombus.
In some variants, the techniques described herein relate to a thermal thrombectomy system, the system including: a member; and a temperature modulation unit configured to apply energy to the member to heat the member to a temperature; wherein the member is configured to be navigated through a blood vessel to apply heat to a thrombus.
In some variants, the techniques described herein relate to a system, wherein the member includes a wire.
In some variants, the techniques described herein relate to a system, wherein the energy is electrical current.
In some variants, the techniques described herein relate to a system, wherein the temperature is 60-200 degrees Celsius.
In some variants, the techniques described herein relate to a thermal thrombectomy system, the system including: an expandable device including one or more heated elements; and a temperature modulation unit configured to apply energy to the one or more heated elements to heat the one or more elements to a temperature; wherein the expandable device is configured to be retracted proximally to apply heat to a thrombus by way of the one or more heated elements.
In some variants, the techniques described herein relate to a system, wherein the expandable device includes an expandable bag configured to capture the thrombus.
In some variants, the techniques described herein relate to a system, wherein the energy is electrical current.
In some variants, the techniques described herein relate to a system, wherein the temperature is 60 or more degrees Celsius.
In some variants, the techniques described herein relate to a method of performing a thrombectomy, the method including: expanding an expandable device distal of a thrombus; applying energy to one or more heated elements of the expandable device to heat the one or more elements to a temperature; retracting the expandable device to interface the one or more heated elements with the thrombus; and capturing the thrombus in the expandable device.
In some variants, the techniques described herein relate to a method, wherein the expandable device includes an expandable bag configured to capture the thrombus.
In some variants, the techniques described herein relate to a method, wherein the energy is electrical current.
In some variants, the techniques described herein relate to a method, wherein the temperature is 60 or more degrees Celsius.
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. 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 thrombi from arteries. Additionally, the systems and methods described herein can be used to remove other occlusions from the body.
The abovementioned and other features of the embodiments disclosed herein are described below with reference to the drawings of the embodiments. The illustrated embodiments are intended to illustrate, but not to limit, the scope of protection. Various features of the different disclosed embodiments can be combined to form further embodiments, which are part of this disclosure.
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.
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 in
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 in
As described herein, the thermal thrombectomy systems and methods disclosed herein may include heating a thrombus. Heating the thrombus may ease penetration of the thrombus. Heating the thrombus may ease breaking the thrombus apart. Heating the thrombus may ease detachment of the thrombus from the wall of the blood vessel. Heating the thrombus may soften and/or emulsify (e.g., melt, liquefy) the thrombus (e.g., One or more proteins (e.g., collagen) and/or other thrombus forming elements (e.g., biopolymers). The thrombus may soften and/or emulsify when heated to a temperature within 60-300 degrees Celsius, 60-200 degrees Celsius, 60-120 degrees Celsius (e.g., 80 degrees Celsius), 60-70 degrees Celsius, and/or 60-80 degrees Celsius. Accordingly, the heated elements (e.g., wires, loops, lassos, hoops, mouths, and/or others) described herein may be heated to 60-300 degrees Celsius, 60-200 degrees Celsius, 60-120 degrees Celsius (e.g., 80 degrees Celsius), 60-70 degrees Celsius, 60-80 degrees Celsius, or other temperatures. For example, the heating element can be heated to 64-70 degrees Celsius, 66-70 degrees Celsius, 68-70 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 heating element can be heated to 64-66 degrees Celsius and/or 66-68 degrees Celsius. The heating element can be heated to about 80 degrees Celsius. The heating element can be heated to any temperature within the foregoing ranges. The temperature of the heating element can be modulated and/or controlled based on temperatures at the heating element and/or interface between the heating element and the thrombus and/or other occlusion. For example, the systems and methods disclosed herein can use one or more temperature sensors (e.g., thermocouples) to sense temperatures at the heating element and/or interface between the heating element and the thrombus and/or other occlusion, and based on the sensed temperatures, modulate and/or control the temperature of the heating element. The system and/or method described herein can include insulation to protect anatomy of the patient from heat.
Heating the thrombus may facilitate a glass transition of the thrombus (e.g., soften), such as the glass transition of the one or more proteins (e.g., collagen) and/or other thrombus forming elements (e.g., biopolymers). For example,
The thermal thrombectomy systems and methods described herein may heat the thrombus, which can include one or more proteins (e.g., collagen) of the thrombus and/or other thrombus forming elements, to a temperature sufficient to soften and/or emulsify (e.g., melt, liquefy) the thrombus, which can include the one or more proteins (e.g., collagen) and/or other thrombus forming elements, and/or facilitate a glass transition of the thrombus, which can include one or more proteins (e.g., collagen) and/or other thrombus forming elements. The thermal thrombectomy systems and methods described herein may heat the thrombus, which can include collagen of the thrombus and/or other thrombus forming elements, to decrease the viscosity of the thrombus, which can include collagen of the thrombus and/or other thrombus forming elements. The temperature to soften the thrombus, which may include one or more proteins and/or other thrombus forming elements, may be the glass transition temperature. The temperature to emulsify (e.g., melt, liquefy) the thrombus, which may include one or more proteins and/or other thrombus forming elements, may be higher than the transition temperature (e.g., melting temperature).
The thermal thrombectomy system 122 may include various software and hardware components to implement aspects of this disclosure, which may at least include a temperature modulation unit 130, controller 132, and/or power source 134 or at least an interface to receive energy from a power source. The wire 124 may be operatively connected to a temperature modulation unit 130. The temperature modulation unit 130 may adjust the temperature of the wire 124 (e.g., heating element, heater, etc.). For example, the temperature modulation unit 130 may raise the temperature (e.g., heat) the wire. The temperature modulation unit 130 may heat the wire 124 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, nuclear, heated liquid, and/or others. For example, the temperature modulation unit 130 may apply a current of electricity to the wire 124, raising the temperature of the wire 124. In some variants, the temperature modulation unit 130 may lower the temperature (e.g., cool) the wire. The temperature of the wire 124 may be heated to the temperatures described herein. The temperature of the wire 124 may be automatically modulated based on monitored conditions (e.g., sensed with a temperature sensor) in a blood vessel and/or at thrombus. The temperature of the wire 124 may be adjusted to accommodate for convection losses. The temperature of the wire 124 may be controlled by a surgeon. The controller 132 may be operatively connected with the temperature modulation unit 130 to perform the temperature control described herein by way of the temperature modulation unit 130.
The power source 134 may be a battery, which may include a rechargeable battery and/or disposable one-time-use battery. The power source 134 may power the thermal thrombectomy system 122, which can include the controller 132 and/or temperature modulation unit 130. The power source 134 may supply the energy to adjust the temperature (e.g., heat) the wire 124. In some variants, the thermal thrombectomy system 122 may be operatively connected to an external power source.
The thermal thrombectomy system 122 may also include memory, communication interface(s) (wired or wireless), user interfaces (e.g., button(s), dial(s), switch(es), display(s), touchpad(s), touchscreen(s), knob(s), trigger(s), indicator(s), gauge(s), and/or slider(s)), etc. to implement aspects of the disclosure. The temperature modulation unit 130, controller 132, power source 134, and/or other components of the thermal thrombectomy system 122 may be housed in a housing 128, which may be a handle.
The thermal thrombectomy system 122 may include a sheath 126, which may also be referred to as a covering or insulation. The sheath 126 may insulate the wire 124 from the anatomy of the patient, such as the blood vessel. The sheath 126 may be disposed over a proximal portion of the wire 124, which may include being disposed over the entirety of the wire 124 except a distal portion. The wire 124, in some variants, may be deployed from and retracted into the sheath 126. In some variants, the sheath 126 may be an insulating coating disposed on the wire 124.
In use, the wire 124 may be navigated through the vascular system to a thrombus. In some variants, the wire 124 can be routed through a catheter to the thrombus. The wire 124 may be heated by the temperature modulation unit 130 to soften and/or emulsify the thrombus, which can include one or more proteins (e.g., collagen) and/or other thrombus forming elements. The wire 124 may be heated by the temperature modulation unit 130 and then advanced into the thrombus to ease penetration, which may be especially advantageous when penetrating a chronic thrombus. As the wire 124 advances through the thrombus, the heat from the wire 124 may soften and/or emulsify the thrombus, which can include the one or more proteins (e.g., collagen) and/or other thrombus forming elements. In some variants, the wire 124 may pass through the thrombus prior to heating, which may enable an expandable device to be disposed distal of the thrombus prior to heating.
In some variants, the wire 124 may include one or more cutting and/or scraping features (e.g., coil, corkscrew, drill, auger, tapered wire drill, constricting coil, scrubbers, umbrella, mesh, and/or others). The one or more cutting features may scape the wall of the blood vessel proximate the thrombus to detach the thrombus from the wall of the blood vessel. The one or more cutting features may cut the thrombus to break up the thrombus. The one or more cutting features may engage with the thrombus to capture the thrombus, such that the surgeon may extract the thrombus by way of retracting the wire 124 proximally out of the patient. The one or more cutting features may be heated to soften and/or emulsify the thrombus, which can include one or more proteins (e.g., collagen) and/or other thrombus forming elements. In some variants, a cutting device and/or an expandable collection device, separate from the wire 124, may be advanced along the wire 124, which may be by way of a sheath or catheter. The cutting device and/or expandable collection device may be heated or not. The sheath 126 may protect the blood vessel from the heat of the wire 124.
The thermal thrombectomy system 122 may include an expandable collection device (e.g., bag, inverted mesh, mesh, cage, umbrella, balloon, basket, funnel, etc.) that may be disposed distally of the thrombus to avoid the thrombus or a fragment (e.g., embolus) thereof breaking off and traveling to another region of the body. In some variants, the wire 124 may integrally include the expandable device. In some variants, an expandable device, separate from the wire 124, may be advanced over the wire 124 with a sheath and/or catheter. The expandable device, in some variants, may include heated portions.
The distal portion of the heated wire 124 may be advanced through the thrombus 108, softening and/or emulsifying the thrombus, which can include the one or more proteins (e.g., collagen) and/or other thrombus forming elements, such that the distal end of the wire 124 is positioned distal of the thrombus 108. The wire 124 may continue to apply heat to the thrombus once through or may cease applying heat. The sheath 126 may insulate the portions of the blood vessel not proximate the thrombus from the heated wire 124. In some variants, the wire 124 may be passed through the thrombus 108 before applying heat via the wire 124.
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The distal end of the wire 124 may be navigated to the location of a thrombus 108. In some variants, the wire 124 may be navigated to the location of the thrombus 108 in a catheter 164, which may also be referred to as a sheath, and with the distal end of the catheter 164 proximate the thrombus 108, the distal end of the wire 124 may be advanced out of the catheter 164 to proximate the thrombus 108. The tapered coil 169 may self-expand outside the catheter 164. As described herein, an energy source may be applied to the wire 124 to heat it. For example, an electrical current may be applied to the wire 124, heating the wire 124. The wire 124 may be heated to a temperature that will soften and/or emulsify the thrombus, which can include one or more proteins (e.g., collagen) and/or other thrombus forming elements, which may at least include any temperature described herein.
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The wires 214, which may be copper wires, may be operatively connected to a wire 216, e.g., Nitinol wire, that cuts and/or detaches thrombi. A current of electricity may be delivered to the wire 216, causing the wire 216 to rise in temperature (e.g., heat). The wire 216 may be disposed inside a sheath 220, which may also be referred to as a sleeve, catheter, and/or tube, that may insulate blood vessels from the heat of the wire 216. The wires 214 may extend into the sheath 220 to operatively connect to the wire 216. An end 218 (e.g., looped end) of the wire 216 way extend from a distal end of the sheath 220. The wire 216 may be heated such that the exposed heated looped end 218 may be used to penetrate into a thrombus 108 while the portion of the wire 216 disposed in the sheath 220 is insulated from the wall 118 of the vein 104 or artery.
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In use, the coil 236 may be deployed prior to penetrating the thrombus. The coil 236 may be advanced distally and/or rotated to thread into thrombus. In some variants, the sheath 220 and wire 216 may penetrate the thrombus prior to the coil 236 being deployed. With the sheath 220 and wire 216 in the thrombus, the sheath 220 may be retracted to deploy the coil 236 in the thrombus. In some variants, the distal end of the sheath 220, with the wire 216 disposed in the sheath 220, may be advanced distal of the thrombus. The wire 216 may be advanced distally relative to the thrombus and/or the sheath 220 may be retracted relative to the wire 216 to move the coil 236 outside the sheath 220 to deploy. With the coil 236 deployed, the wire 216 may be retracted in a proximal direction and/or rotated into the thrombus.
Different portions of the wire 216 may be heated. For example, in some variants, the straight portion 234, looped end 218, and/or coil 236 may be heated. In some variants, the straight portion 234, looped end 218, and/or coil 236 may be insulated (e.g., include an insulating material, insulating coating, insulating cover, etc.). In some variants, the inner periphery of the coil 236 may be heated and the outer periphery of the coil 236 may be insulated.
In use, the lasso 278 may be deployed prior to penetrating the thrombus. The lasso 278 may be advanced distally and/or rotated into thrombus. In some variants, the sheath 220 and wire 216 may penetrate the thrombus prior to the lasso 278 being deployed. With the sheath 220 and wire 216 in the thrombus, the sheath 220 may be retracted to deploy the lasso 278 in the thrombus. In some variants, the distal end of the sheath 220, with the wire 216 disposed in the sheath 220, may be advanced distal of the thrombus. The wire 216 may be advanced distally relative to the thrombus and/or the sheath 220 may be retracted relative to the wire 216 to move the lasso 278 outside the sheath 220 to deploy. With the lasso 278 deployed, the wire 216 may be retracted in a proximal direction and/or rotated into the thrombus, which may capture the thrombus for extraction, fragment the thrombus, and/or detach the thrombus from the vessel walls.
The wire 216 may include a straight portion 234. The straight portion 234 may extend the length of the coil 236. The straight portion 234 may extend through the coil 236, which may include extending coaxially along a longitudinal axis of the coil 236. The straight portion 234 may extend through the coil 236 within an inner periphery of the coil 236. The proximal end of the straight portion 234 may be operatively connected (e.g., by way of a wire) to the energy source (e.g., source of electrical energy). The coil 236 and the straight portion 234 may join together distally (e.g., the distal ends of the coil 236 and the straight portion 234 may be joined together). For example, a transverse portion 242 (e.g., perpendicular portion) may connect the distal end of the straight portion 234 with the distal end of the coil 236. Energy, such as electrical energy, can be applied to the wire 216 to heat the wire 216 to soften and/or emulsify the thrombus, which can include one or more proteins (e.g., collagen) and/or other thrombus forming elements, which may ease penetration of the thrombus, detaching (e.g., scraping) the thrombus from the walls of the blood vessel, and/or fragmenting the thrombus. The sheath 220 may insulate the patient's anatomy from the heat of the wire 216 not unsheathed. The wire 216 may be placed (e.g., retracted) into the sheath 220, and when the wire 216 is distally advanced to move the coil 236 out of the sheath 220, the coil 236 may automatically deploy (e.g., expand). The wire 216 may be placed in a catheter, and when the wire 216 is distally advanced to move the coil 236 out of the catheter, the coil 236 may automatically deploy (e.g., expand). The coil 236 may self-expand outside the sheath 220.
In use, the coil 236 may be deployed prior to penetrating the thrombus. The coil 236 may be advanced distally and/or rotated to thread into thrombus. In some variants, the sheath 220 and wire 216 may penetrate the thrombus prior to the coil 236 being deployed. With the sheath 220 and wire 216 in the thrombus, the sheath 220 may be retracted to deploy the coil 236 in the thrombus. In some variants, the distal end of the sheath 220, with the wire 216 disposed in the sheath 220, may be advanced distal of the thrombus. The wire 216 may be advanced distally relative to the sheath 220 and/or the sheath 220 may be retracted relative to the wire 216 to move the coil 236 outside the sheath 220 to deploy. With the coil 236 deployed, the wire 216 may be retracted in a proximal direction and/or rotated into the thrombus, which may capture the thrombus for extraction, fragment the thrombus, and/or detach the thrombus from the vessel walls.
Different portions of the wire 216 may be heated. For example, in some variants, the straight portion 234, looped end 218, and/or coil 236 may be heated. In some variants, the straight portion 234, looped end 218, and/or coil 236 may be insulated (e.g., include an insulating material, insulating coating, insulating cover, etc.). In some variants, the inner periphery of the coil 236 may be heated and the outer periphery of the coil 236 may be insulated.
In use, the outer coil 270 and the inner coil 272 may be deployed prior to penetrating the thrombus. The outer coil 270 and the inner coil 272 may be advanced distally and/or rotated to thread into thrombus. In some variants, the sheath 220 and wire 216 may penetrate the thrombus prior to the outer coil 270 and the inner coil 272 being deployed. With the sheath 220 and wire 216 in the thrombus, the sheath 220 may be retracted to deploy the outer coil 270 and the inner coil 272 in the thrombus. In some variants, the distal end of the sheath 220, with the wire 216 disposed in the sheath 220, may be advanced distal of the thrombus. The wire 216 may be advanced distally relative to the sheath 220 and/or the sheath 220 may be retracted relative to the wire 216 to move the outer coil 270 and the inner coil 272 outside the sheath 220 to deploy. With the outer coil 270 and the inner coil 272 deployed, the wire 216 may be retracted in a proximal direction and/or rotated into the thrombus, which may capture the thrombus for extraction, fragment the thrombus, and/or detach the thrombus from the vessel walls.
Different portions of the wire 216 may be heated. For example, in some variants, the outer coil 270 and/or the inner coil 272 may be heated. In some variants, the outer coil 270 and/or the inner coil 272 may be insulated (e.g., include an insulating material, insulating coating, insulating cover, etc.). For example, as illustrated in
In use, the first flute 281 and second flute 282 may be deployed prior to penetrating the thrombus. The first flute 281 and second flute 282 may be advanced distally and/or rotated to thread into thrombus. In some variants, the first flute 281 and second flute 282 may deployed in the thrombus. In some variants, the first flute 281 and second flute 282 may deployed distal to the thrombus and then retracted into the thrombus, which may include rotating.
Different portions of the cutting device 280 may be heated. For example, in some variants, the wire 216, first flute 281, second flute 282, and/or portions of the catheter 276 may be heated. In some variants, the wire 216, first flute 281, second flute 282, and/or portions of the catheter 276 may be insulated (e.g., include an insulating material, insulating coating, insulating cover, etc.).
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In use, the distal end of the thermal thrombectomy system 246 may be disposed proximate a thrombus. The diameter of the variable lasso 248 may be set based on the diameter of the vessel. Electrical energy may be applied to the variable lasso 248 to heat the variable lasso 248. The variable lasso 248 may be advanced to soften and/or emulsify the thrombus, which can include one or more proteins (e.g., collagen) and/or other thrombus forming elements to detach the thrombus from the vessel wall and/or fragment the thrombus.
The thermal thrombectomy systems and methods disclosed herein may use oscillating, sharp ends, and/or vibration. The thermal thrombectomy systems and methods disclosed herein may use grounding/aspiration action. The thermal thrombectomy systems and methods disclosed herein may use a wire of uniform or varying diameter. The thermal thrombectomy systems and methods disclosed herein may include a coil within uniform or varying diameter. The thermal thrombectomy systems and methods disclosed herein may liquefy a thrombus without cauterizing blood or vasculature. The thermal thrombectomy systems and methods disclosed herein may allow minimal invasive use of a suction tool. The thermal thrombectomy systems and methods disclosed herein may include a cutting element off axis (away from the vessel wall) to prevent ablation or cutting of the endolumen. The thermal thrombectomy systems and methods disclosed herein may include coils that scrape the blood vessel walls or are radially inset from the blood vessel wall. The thermal thrombectomy systems and methods disclosed herein may be used to cut unwanted tissue in a controlled manner. The thermal thrombectomy systems and methods disclosed herein may be used to cut false lumen. The thermal thrombectomy systems and methods disclosed herein may include coils with lead-in circular, closed loop, or elliptical coils. The thermal thrombectomy systems and methods disclosed herein may be disposed about the entire perimeter of a thrombus and/or inside a vessel wall border the thrombus. The thermal thrombectomy systems and methods disclosed may use a ultrasonic cutter/jackhammer. The thermal thrombectomy systems and methods disclosed herein may include a water jet back toward a cannula and/or pressurized saline. The thermal thrombectomy systems and methods disclosed herein may include coil diameters between 5 and 16 millimeters. The thermal thrombectomy systems and methods disclosed herein may include coil lengths between endothelial cells 120 and aspiration openings 190 millimeters. The thermal thrombectomy systems and methods disclosed herein may include a wire diameter of 25 millimeters.
Thrombi can form at various locations. Thrombi can impair the function of valves 110 (e.g., prevent movement) and/or impede (e.g., partially block, completely block) the flow of blood along the flow path 106 through the vein 104.
As described herein, a thrombus can change from acute to chronic overtime.
The systems and methods described herein can at least be used to remove the thrombi illustrated in
In some variants, the capture device 306 can include a sheath 314, as illustrated in
In some variants, the loop 312 and/or bag 310 can include a diameter that is greater than a diameter of the vein 104, as illustrated in
In some variants, the system 301 can omit the capture device 306, as illustrated in
The system 318 can include a thermal control system 380 (e.g., temperature control system). The thermal control system 380 can control the temperature (e.g., heating) of a heating element (e.g., loop, mouth, etc.) to emulsify a thrombus. The thermal control system 380 can include a heater 385 (e.g., variable current driver, current driver) that can heat a heating element 386, which can include heating by way of electricity. The heater 385 can heat the heating element 386 to at least temperatures described herein or above to accommodate for heat loss. Wiring for the heater 385 can be routed through a device interface 390 to the heating element (e.g., loop, mouth, etc.) that is disposed inside the blood vessel of the patient. The heating element can be heated to at least the temperatures described herein.
The thermal control system 380 can include a temperature sensor interface 384 (e.g., thermocouple interface, T-type thermocouple interface). The temperature sensor interface 384 can interface with one or more temperature sensors 388 (e.g., thermocouple(s)). The temperature sensor 388 can sense the temperature at or proximate the heating element (e.g., loop, mouth, etc.) and/or at or proximate the interface between the heating element and the thrombus disposed inside the blood vessel of the patient. Wiring for the temperature sensor 388 can be routed through a device interface 390 to or proximate the heating element (e.g., loop, mouth, etc.). The thermal control system 380 can modulate the heat of the heating element based on temperatures and/or pressures sensed at the heating element and/or interface between the heating element and the thrombus.
The system 318 can include a pneumatic system 320 (e.g., aspiration system). The pneumatic system 320 can be used to aspirate a thrombus and/or other occlusion from the blood vessel of the patient. The pneumatic system 320 can include a pump 326 (e.g., vacuum pump), accumulator 324, relief valve 322, pressure gauge 328, filter 330, tank 332, and/or valve 334 (e.g., solenoid valve 334). The tank 332 can receive aspirated material (e.g., thrombi and/or other occlusive material). The system 318 can include a gauge to indicate the fill level of the tank 332, which can include a gauge of the user interface 372. The pneumatic system 320 can be operatively coupled to the device interface 390 to facilitate aspiration.
The system 318 can include a pneumatic control system 336 (e.g., aspiration control system). The pneumatic control system 336 can include a pump driver 338. The pump driver 338 can drive the vacuum pump 326. The pneumatic control system 336 can include a pressure sensor 342, which can sense pressures within the thermal control system 380 and/or the blood vessel. The pneumatic control system 336 can include a valve actuation unit 344 that can actuate (e.g., open, close) the solenoid valve 334. The pneumatic control system 336 can include a pressure safety unit 340 that can monitor pressures within the thermal control system 380 and/or the blood vessel. The pressure safety unit 340 can, when certain pressures are detected, initiate a safety protocol (e.g., cease driving the vacuum pump 326 with the pump driver 338).
The system 318 can include a power system 346. The power system 346 can include a battery 348, which can be rechargeable. The power system 346 can include a gauge 350. The gauge 350 can indicate the status of the battery 348 (e.g., percentage charged, etc.). The power system 346 can include a charging interface 354. The charging interface 354 can interface with a cable 358 (e.g., charging cable) that can interface with a power source 360 (e.g., outlet) to charge the battery 348 and/or directly power the system 318. The power system 346 can include a power management unit 356 and/or voltage regulator 352.
The system 318 can include a control system 362. The control system 362 can execute the methods described herein. The control system 362 can include a micro controller 364, real-time clock 368 (e.g., RTC), and/or memory 366. The real-time clock 368 can be used to monitor durations of methods and/or steps of methods described herein (e.g., duration heating element is at a temperature). The real-time clock 368 can be used to identify triggering events for the system 318 to respond to. The system 318 can include a data interface 370 that can facilitate connecting the system 318 to a computing system to communicate data.
The system 318 can include a user interface system 372. The user interface system 372 can include one or more button(s) 374, which can at least be used to adjust temperature of the heating element, start/stop heating and/or aspiration, change modes, open and/or shut valves, power on/off, and/or other adjustments. The user interface system 372 can, 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 system 372 can include indicator(s) 376 (e.g., indicator lights, such as LEDs). The indicator(s) 376 can visually indicate when the system 318 is ready for operation and/or not ready for operation. The indicator(s) 376 can visually indicate when the system 318 is aspirating and/or heating. The indicator(s) 376 can indicate the charge level of the battery 348. The indicator(s) 376 can indicate when the system 318 is communicating with another computing system (e.g., transmitting data). The indicator(s) 376 can emit warnings. The indicator(s) 376 can emit various colors and/or patterns of light. The user interface system 372 can include a speaker(s) 532 (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 system 372 can include one or more displays, touchscreens, microphones for spoken commands, etc. In some variants, the indicator(s) 376, speaker(s) 378, display, touchscreen, etc. can indicate the status of the system 318, which can at least include indicating when the heating element is being heated, how long the heating element has been at a temperature or above a temperature, a temperature of the heated element, when the system 318 is aspirating, etc.
The system 318, in some variants, can include a wired communication interface and/or a wireless communication interface to communicate with other computing devices. The system 318 can include a processor and/or other hardware to perform the methods described herein.
The thermal controller system 400 can include a heater 412 (e.g., variable heater current driver). The variable heater current driver 412 can heat a heating element (e.g., loop, mouth, etc.) by way of a conduit 422 (e.g., wire) routed to or proximate a heating element The variable heater current driver 412 can heat the heating element to at least the temperatures described herein.
The thermal controller system 400 can include a temperature sensor interface 414 (e.g., T-type temperature sensor interface chip). The temperature sensor interface 414 can be operatively connected to a temperature sensor (e.g., thermocouple) by way of one or more wires 422 or the like. The temperature sensor can be disposed proximate the heating element, which can include being proximate the interface between the heating element and the thrombus or other occlusion. The thermal controller system 400 can include a safety sensing unit 416, which can monitor the temperature sensed by the temperature sensor. The safety sensing unit 416 can trigger a safety protocol based on the temperature sensed by the temperature sensor, which can include stopping the variable heater current driver 412 from heating the heating element, generating an alert, etc.
The thermal controller system 400 can include a microcontroller 406, data interface 410 (e.g., USB interface), and/or memory 408. The data interface 410 can be used to connect the thermal controller system 400 to a computing system. In some variants, the thermal controller system 400 can include a wireless data interface to enable the thermal controller system 400 to communicate wirelessly with a computing system. The thermal controller system 400 can include a memory 408. The memory 408 can include instructions, protocols, etc. The memory 408 can include a log of data for the thermal controller system 400, which can include temperature data, use data, etc.
The thermal controller system 400 can include a power management unit 402. The thermal controller system 400 can include a battery 404, which can be a rechargeable battery (e.g., medical grade rechargeable battery). The power management unit 402 can manage the current drawn from the battery 404.
The thermal controller system 400 can include a user interface 418, which can be custom. The user interface 418 can be used to control the thermal controller system 400. The user interface 418 can enable the thermal controller system 400 to communicate with the user. The user interface 418 can include light(s) (e.g., LED(s)), button(s), dial(s), switch(es), display(s), touchpad(s), touchscreen(s), knob(s), trigger(s), indicator(s), gauge(s), slider(s), speaker(s), buzzer(s), etc. The user interface 418 can enable a user to adjust the temperature of the heating element (e.g., enable two degrees Celsius adjustments, one degree Celsius adjustments, or even smaller incremental adjustments). The user interface 418 can indicate the charge level of the battery 404.
The thermal controller system 400 can include a short circuit detection system. The thermal controller system 400 can include a short circuit shut-off. The thermal controller system 400 can include insulation failure detection. The thermal controller system 400 can include over-heat protection of the catheter tip and/or electronics at a handle of the thermal controller system 400.
The thermal device 446 (e.g., cutting device) can include a heated loop 444 (e.g., hoop, lasso). The loop 444 can be formed from a wire 448. The wire 448 can be routed distally, form the loop 444, and then be routed proximally. The loop 444 can include a distally extending portion 442. The distally extending portion 442 can be disposed at a top of the loop 444. The distally extending portion 444 can include a u-shaped bend in the wire 448, which can ease distal movement of the loop 444. The wire 448 can be routed distally, form a portion (e.g., half) of the loop, extend distally and loop back proximally to form the distally extending portion 444 (e.g., u-shaped bend), form anther portion (e.g., half) of the loop, and be routed proximally. The loop 444 can be generally centered around the longitudinal axis of the catheter 436. The proximal portions of the wire 448 can be disposed inside of a material (e.g., encased), which can be insulating. The loop 444 and/or loop 431 can be angled distally (e.g., tilted distally). In some variants, the catheter 436 can be routed through another catheter to the thrombus. In some variants, a wire (e.g., guide wire), which can be heated, can be routed through the catheter and not through the catheter 436 to the thrombus.
As described herein, a heated element (e.g., heated wire, heated guide wire) can be advanced distally through the catheter 436 or another catheter to a thrombus or other occlusion. The heated element can be heated and advanced to penetrate the thrombus. The heat can ease penetration of the thrombus by the heated element. The distal end of the catheter 436 can be proximal relative to the distal end of the heated element. The heated element and distal end of the catheter 436 can be advanced to distal of the thrombus. In some variants, the distal end 442 of the thermal device 446 can be advanced distally of the catheter 436 and heated to penetrate the thrombus, instead of using a separate heated element (e.g., heated wire, heated guide wire). The heat from the distal end 442 of the thermal device 446 can ease penetration of the thrombus. The distal end 442 and the distal end of the catheter 436 can be advanced to distal of the thrombus.
The sheathed capture device 428 can be advanced distally out of the catheter 436. The sheath 438 can be retracted proximally to unsheathe the capture device 428 (e.g., the bag 430 and loop 431) to allow the capture device 428 (e.g., the bag 430 and loop 431) to self-expand. The thermal device 446 can be advanced out of the catheter 436 to allow the loop 444 to self-expand. The loop 444 can be heated and retracted proximally to the thrombus. The heated loop 444 can separate the thrombus from the wall of the vessel. The heated loop 444 can emulsify the thrombus (e.g., a periphery of the thrombus). The capture device 428 can be retracted proximally to capture the thrombus detached from the vessel wall. With the thrombus in the bag 430, the capture device 428, thermal device 446, and/or catheter 436 can be retracted proximally out of the patient to remove the thrombus.
In use, a heated element (e.g., wire, guide wire) can be positioned distally relative to the catheter 476 to interface with a thrombus. The heated element can penetrate the thrombus. The heat from the heated element can ease penetration, which can include emulsifying the thrombus (e.g., central portion of the thrombus). The heated element can cross over (e.g., pass through) the thrombus to a distal side thereof. The catheter 476 with the capture device 484 disposed therein can be advanced with the heated element or after the heated element such that a distal end of the catheter 476 is distal of the thrombus. The capture device 484 can be advanced out of the catheter 476 to deploy (e.g., self-expand) distally of the thrombus. The loop 478 can be heated. The heated loop 478 with the integrated bag 480 can be retracted proximally. The heated loop 478 can interface with the thrombus, which can include emulsifying the thrombus. The heated loop 478 can detach the thrombus from the vessel wall. The thrombus can be captured in the bag 480. The system 474 can be retracted proximally out of the patient with the thrombus in the bag 480. In some variants, the distal end 482 can be heated and advanced distal of the catheter 476 to penetrate the thrombus and facilitate crossover of the thrombus instead of or in combination with a separate heated element.
In use, a heated element (e.g., wire, guide wire) can be positioned distally relative to the catheter 488 to interface with the thrombus. The heated element can penetrate the thrombus. The heat from the heated element can ease penetration, which can include emulsifying the thrombus (e.g., central portion of the thrombus). The heated element can cross over (e.g., pass through) the thrombus to a distal side thereof. The catheter 488 with the capture device 490 and thermal device 491 disposed inside the catheter 488 can be advanced with the heated element or after the heated element such that a distal end of the catheter 488 is distal of the thrombus. The heated element can be retracted proximally back into the catheter 488. The capture device 484 and thermal device 491 coupled to the capture device 484 can be advanced out of the catheter 488 to deploy (e.g., self-expand) distally of the thrombus. The loop 498 can be heated. In some variants, the bag 492 or portions thereof can be heated. The loop 498 and capture device 490 can be coupled together, which can include being coupled (e.g., connected, tethered) together. The thermal device 491 and capture device 490 can be retracted proximally together so that the loop 498 of the thermal device 491 interfaces with the thrombus, which can emulsify the thrombus (e.g., periphery of the thrombus) with the heat from the loop 498. The heat form the loop 498 can help detach the thrombus from the wall of the blood vessel. The thrombus can be captured in the bag 492. With the thrombus captured in the bag 492, the thermal device 491 and capture device 490 can be retracted proximally from the patient to remove the thrombus. In some variants, the distal end 494 can be heated and advanced to distal of the catheter 488 to penetrate the thrombus and facilitate crossover of the thrombus instead of or in combination with a separate heated element.
The system 502 can include a capture device 504. The capture device 504 can include a bag 518 (e.g., mesh, net, cage, basket). The bag 518 can be tapered in a proximal-distal direction. The capture device 504 can include one or more wire(s) 514. The wire 514 can be routed through the catheter 506 to enable a surgeon to maneuver the capture device 504. The wire 514 can form a loop 516 (e.g., hoop, lasso) at the opening into the bag 518. The wire 514 can extend from the loop 516 at the opening of the bag 518 to a distal end 520 of the capture device 504 (e.g., bag 518), which can be referred to as an extension boom and/or boom. The distal end 520 of the capture device 504 can be rigid, which can be provided by the wire 514. The opening into the bag 518 can be generally centered around the longitudinal axis of the catheter 506. In some variants, the wire 514 can be heated.
In use, a heated element (e.g., wire, guide wire) can be positioned distally relative to the catheter 506 to interface with a thrombus. The heated element can penetrate the thrombus. The heat from the heated element can ease penetration, which can include emulsifying the thrombus (e.g., central portion of the thrombus). The heated element can cross over (e.g., pass through) the thrombus to a distal side thereof. The catheter 506 with the thermal device 505 and capture device 504 disposed therein can be advanced with the heated element or after the heated element such that a distal end of the catheter 506 is distal of the thrombus. The thermal device 505 and/or capture device 504 can be advanced out of the catheter 506 to deploy (e.g., self-expand) distally of the thrombus. The loop 508 can be heated. The heated loop 508 can be retracted proximally. The heated loop 508 can interface with the thrombus, which can include emulsifying the thrombus. The heated loop 508 can detach the thrombus from the vessel wall. The thrombus can be captured in the bag 518. The system 502 can be retracted proximally out of the patient with the thrombus in the bag 518. In some variants, the distal end 520 and/or distal end 512 can be heated and advanced distal of the catheter 506 to penetrate the thrombus and facilitate crossover of the thrombus instead of or in combination with a separate heated element.
The system 522 can include a capture device 524 (e.g., expandable device). The capture device 524 can include a bag 526 (e.g., mesh, net, cage, basket). The bag 526 can include distal end 528, which can be rounded. The bag 526 can include a generally consistently sized periphery. The capture device 524 can include one or more wire(s) 530. The wire 530 can be routed through the catheter 532 to enable a surgeon to maneuver the capture device 524. The wire 530 can form a loop 538 at the opening into the bag 526. The opening into the bag 526 can be generally centered around the longitudinal axis of the catheter 532. In some variants, the wire 530 can be heated. In some variants, the portion of the wire 530 extending around the opening into the bag 526 forming the loop 538 can be heated. The capture device 524 can include a sheath 540. The sheath 540 can be disposed over the bag 526 to impede expansion of the bag 526. The sheath 540 can be retracted proximally to uncover the bag 526. The unsheathed bag 526 can self-expand. For example, the portion of the wire 530 extending around the opening of the bag 526 to form the loop 538 can self-expand.
In use, a heated element (e.g., wire, guide wire) can be positioned distally relative to the catheter 532 to interface with a thrombus. The heated element can penetrate the thrombus. The heat from the heated element can ease penetration, which can include emulsifying the thrombus (e.g., central portion of the thrombus). The heated element can cross over (e.g., pass through) the thrombus to a distal side thereof. The catheter 532 with the thermal device 525 and capture device 524 disposed therein can be advanced with the heated element or after the heated element such that a distal end of the catheter 532 is distal of the thrombus. The thermal device 525 and/or capture device 526 can be advanced out of the catheter 506. The sheath 540 of the capture device 524 can be retracted. The unsheathed bag 526 can expand (e.g., self-expand). The loop 534 can be heated. The heated loop 534 can be retracted proximally. The heated loop 534 can interface with the thrombus, which can include emulsifying the thrombus. The heated loop 534 can detach the thrombus from the vessel wall. The thrombus can be captured in the bag 526. The system 522 can be retracted proximally out of the patient with the thrombus in the bag 526. In some variants, the distal end 536 can be heated and advanced distal of the catheter 532 to penetrate the thrombus and facilitate crossover of the thrombus instead of and/or in combination with a separate heated element.
In use, a heated element (e.g., wire, guide wire) can be positioned distally relative to a catheter to interface with a thrombus. The heated element can penetrate the thrombus. The heat from the heated element can ease penetration, which can include emulsifying the thrombus (e.g., central portion of the thrombus). The heated element can cross over (e.g., pass through) the thrombus to a distal side thereof. The catheter with the capture device 542 disposed therein can be advanced with the heated element or after the heated element such that a distal end of the catheter is distal of the thrombus. The capture device 542 can be advanced out of the catheter to deploy (e.g., expand, self-expand) distally of the thrombus. In some variants, the capture device 542 can be disposed in a sheath. The sheath can be retracted to uncover the capture device 542 so that the capture device 542 expands (e.g., self-expands). The heated element 546 can be heated. The capture device 542 can be retracted proximally to interface the heated element 546 with the thrombus, which can emulsify the thrombus (e.g., periphery of the thrombus). The heated element 546 and/or loop 544 can detach the thrombus from the vessel wall. The thrombus can be captured in the bag 548. The capture device 542 can be retracted proximally out of the patient with the thrombus in the bag 548. In some variants, the distal end 552 can be heated and advanced distal of the catheter to penetrate the thrombus and facilitate crossover of the thrombus instead of or in combination with a separate heated element.
Thrombi can be heterogeneous. Different regions of a thrombus can emulsify at different rates at different temperatures. In some variants, altering a temperature of a heated element (e.g., wire, loop, mouth, funnel, etc.) based on the characteristics of the thrombus at the interface between the thrombus and the heated element can be beneficial. For example, it may be beneficial to raise a temperature of the heated element 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 heated element based on the characteristics of the region of the thrombus with which the heated element is interfacing.
The wires and/or heated elements described herein can be made of a variety of materials, such as stainless steel, shape memory alloy (e.g., nickel titanium), etc. In some variants, voltage drop can be protected through grounding wire detection. In some variants, closed-loop techniques and/or artificial intelligence can control (e.g., modulate) the heat (e.g., current) applied by the systems described herein. In some variants, the detection of the type of material, thrombus, 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.
As illustrated, the thermal thrombectomy system 600 can include a thermal assembly 602 (e.g., crossing assembly, thermal crossing assembly) and/or an anchoring assembly 603 (e.g., balloon assembly, expandable assembly). The thermal assembly 602 can be used to penetrate, cross, and/or fragment a thrombus. The anchoring assembly 603 can be used to anchor the thermal thrombectomy system 600 within vasculature to facilitate advancing the thermal assembly 602 distally to penetrate a thrombus. The anchoring assembly 603 can be used to impede the flow of fluid and/or thrombus proximally. The anchoring assembly 603 can be used to center the thermal assembly 602 (e.g., heated element thereof) within vasculature.
The anchoring assembly 603 can include a sheath 628 (e.g., tube, catheter, outer tube). The anchoring assembly 603 can include an expandable device 630 (e.g., balloon, umbrella). The expandable device 630 can be disposed on a distal portion of the sheath 628. The expandable device 630 can be expanded (e.g., inflated) when positioned in vasculature to contact blood vessel walls (e.g., vein or artery walls), which can anchor the anchoring assembly 603 and/or thermal thrombectomy system 600 in place within the blood vessel. The expanded expandable device 630 can impede the proximal flow of fluid, such as blood, and/or thrombus. The expandable device 630, when a balloon, can be filled or emptied of a gas and/or fluid to expand or deflate. The expandable device 630, when an umbrella or the like, can be expanded using shape memory material or other techniques. The expandable device 630 can center the anchoring assembly 603 (e.g., sheath 628) within the vasculature when expanded to contact the vessel walls.
The anchoring assembly 603 can include a connector 620 (e.g., Y coupling, coupler, Y coupler, Y connector). The connector 620 can be disposed at a proximal portion of the sheath 628. The connector 620 can include a port 622 (e.g., angled port, inlet, inflation port). Gas and/or fluid can be introduced or removed through the port 622 of the connector 620 to inflate or deflate the expandable device 630. For example, the gas and/or fluid can flow through the port 622 and interior of the sheath 628 to the expandable device 630 for inflation.
The connector 620 can include a port 626 (e.g., flush port, inlet, flush inlet). Fluid can be introduced into the sheath 628 by way of the port 626 to flush the anchoring assembly 603 of air to reduce the risk that air is introduced into the vasculature.
The connector 620 can include a port 623 (e.g., straight port, main port). The port 623 can receive the thermal assembly 602, guide wire, and/or other devices therethrough.
The connector 620 can include a valve 624 (e.g., Tuohy-Borst valve, adapter, Tuohy-Borst adapter). The valve 624 can seal and/or clamp onto the thermal assembly 602, such as a tube 618 of the thermal assembly 602. The valve 624 can be disposed on the port 623.
The thermal assembly 602 can be introduced through the anchoring assembly 603. For example, the thermal assembly 602 can include the tube 618 (e.g., catheter, outer tube). The tube 618 can be advanced distally through the anchoring assembly 603. For example, the tube 618 can be advanced through the connector 620 (e.g., port 623, valve 624 on the port 623 of the connector 620) and the sheath 628 of the anchoring assembly 603. The tube 618 can be advanced distally through the sheath 628 such that a distal portion of the tube 618 can extend distally out of the sheath 628 (e.g., distal of a distal end of the sheath 628).
The thermal assembly 602 can include a heated element 632 (e.g., electrode, heated wire, heated tube, heated loop, heated member, heated tip, heated end, heated distal portion, heated distal end). The heated element 632 can be disposed on a distal portion of the tube 618 such that advancing the tube 618 distally out of the sheath 628 positions the heated element 632 distal of a distal end of the sheath 628. The heated element 632 can be heated. The heated element 632 can 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, hot liquid, nuclear, and/or others. The heated element 632 can include a variety of materials, which can at least include shape memory materials (e.g., shape memory alloy, shape memory polymer, Nitinol, nickel-titanium alloy), metals, metal alloys, polymers, ceramics, etc. The heated element 632 can be advanced to contact a thrombus to ease penetration of the thrombus, soften and/or emulsify the thrombus, cross the thrombus, and/or break up (e.g., fragment) the thrombus. The heated element 632 can be used to core the thrombus. The expanded expandable device 630 can anchor the thermal thrombectomy system 600 within the vasculature to facilitate advancing the heated element 632 (e.g., facilitate penetrating the thrombus). Wiring can be routed to the heated element 632 through the interior of the tube 618.
The thermal assembly 602 can include a connector 604 (e.g., Y coupling, coupler, Y coupler, Y connector). The connector 604 can be disposed at a proximal portion of the tube 618. The connector 604 can include a port 606 (e.g., angled port, inlet, inflation port). One or more conductors (e.g., wire(s)) for the thermal thrombectomy system 600 can be routed through the port 606. For example, conduits for heating, temperature sensing, leakage current sensing, and/or mechanical agitators can be routed through the port 606 and into the tube 618.
The thermal assembly 602 can include a handpiece 616 (e.g., controller, handle). The handpiece 616 can include electronics (e.g., battery, rechargeable battery, controller, processor, memory, timer, wireless communication interface, transceiver, power interface, etc.) to facilitate the functionalities of the thermal thrombectomy system 600 described herein. The handpiece 616 can be used to control the temperature of the heated element 632. For example, an electrical current can be applied from a battery of the handpiece 616 to the heated element 632. In some variants, electrical current can be applied from an external power source to the heated element 632. The electronics (e.g., controller) of the handpiece 616 can be used to automatically control the temperature of the heated element 632, which can be based on sensed temperature(s) and/or sensed current leakage. For example, if the sensed temperature is above a threshold, the controller of the handpiece 616 can lower the temperature of the heated element 632 (e.g., adjust electrical current and/or voltage to lower temperature). If the sensed temperature is below a threshold, the controller of the handpiece 616 can raise the temperature of the heated element 632 (e.g., adjust electrical current and/or voltage to raise temperature). If leaked current is sensed, the controller of the handpiece 616 can cease applying a current to the heated element 632.
The thermal assembly 602 can include an electrical connector 614 (e.g., push-pull latching electrical connector). The conduits for heating, temperature sensing, leakage current sensing, and/or mechanical agitators can be connected to the electrical connector 614. The electrical connector 614 can be coupled (e.g., releasably coupled) with the handpiece 616. The conduits can be routed from the electrical connector 614 to the port 606 of the connector 604 by way of a tube 612 (e.g., flexible tube, conduit, flexible conduit). The tube 612 can be insulated.
The connector 604 can include a port 607 (e.g., straight port, main port). A hub 610 (e.g., valve, connector) can be disposed on the port 607.
A guide wire 608 (e.g., wire) can be used to navigate the thermal thrombectomy system 600 to a thrombus. For example, the guide wire 608 can be routed through the vasculature of a patient and the thermal thrombectomy system 600 can be advanced over the guide wire 608. For example, the sheath 628 and/or tube 618 can be advanced over the guide wire 608. The guide wire 608 can extend through the port 607, hub 610, tube 618, port 623, valve 624, and/or sheath 628 to distal of the sheath 628. The hub 610 can seal around guide wire 608, which can impede fluid from escaping.
The handpiece 616 can include a button 634 or the like (e.g., toggle, switch, dial, etc.) to activate (e.g., begin heating) the heated element 632. In some embodiments, the handpiece 616 can include a display (e.g., gauge) and/or other indicator that can indicate the sensed temperature at the heated element 632, status (e.g., activated or not) of the heated element 632, if current leakage has been detected, and/or other characteristics of the thermal thrombectomy system 600. In some embodiments, the handpiece 616 can include a user interface (e.g., button, touch screen, toggle, switch, dial) to set a target temperature for the heated element 632.
The thermal assembly 602 can include a feature for fluoroscopy and/or X-ray visualization. The thermal assembly 602 can include one or more features for detecting current leaks from the heated element 632. For example, the thermal assembly 602 can include an electrode and marker, which can be the same feature. The thermal assembly 602 can include an electrode 650, which can be a band, annular structure, and/or ring. The electrode 650 can be disposed around the distal end 646. The electrode 650 can be disposed around the tube 618. The electrode 650 can be used for visualization for navigating through the vasculature, which can at least include fluoroscopy and/or X-ray visualization techniques. The electrode 650 can be used to detect a current escaped from the heated element 632. If current is detected (e.g., current above a threshold is detected), the thermal assembly 602 can cease applying an electrical current to the heated element 632.
As illustrated in
The thermal assembly 602 can include a temperature sensor 643 (e.g., thermocouple). The temperature sensor 643 can be disposed at the heated element 632 to sense temperature at the heated element 632. The temperature sensor 643 can be disposed inside of the heated element 632. As shown in
The thermal assembly 602 can include insulation 652 (e.g., an insulating sleeve) over at least one of the legs of the heated element 632 (e.g., one of the legs of the loop of the heated element 632) which can help reduce the likelihood of shorts between the legs of the loop.
As illustrated in
To expand the expandable device 630 (e.g., balloon), a fluid and/or gas can be introduced through the port 622. The fluid and/or gas can travel in the gap 662 between the tube 654 and the sheath 628 until flowing into the expandable device 630 by way of the one or more openings 656 to fill the expandable device 630. To deflate the expandable device 630, the fluid and/or gas can flow back through the one or more openings 656, in the gap 662 between the tube 654 and the sheath 628, and out the port 622.
As illustrated in
In use, the guide wire 608 can be navigated through vasculature to a thrombus. The thermal assembly 602 (e.g., tube 618) can be advanced through the anchoring assembly 603. For example, the thermal assembly 602 (e.g., tube 618) can be advanced distally through the connector 620 (e.g., valve 624, tube 654) and the tube 654 disposed inside the sheath 628, which can include being advanced distally inside the sheath 628 until within a distal portion of the sheath 628 such as shown in
With the distal portions of the thermal assembly 602 and anchoring assembly 603 disposed proximate and proximally of a thrombus and/or other occlusion, the expandable device 630 can be expanded. Fluid and/or gas can be introduced through the port 622 to inflate the expandable device 630 as described herein. The expandable device 630 can expand to contact the surrounding vessel walls to anchor and/or center the anchoring assembly 603. The valve 624 can be unclamped from the tube 618 of the thermal assembly 602. The thermal assembly 602 can be advanced such that the heated element 632 is disposed distally out of the tube 654 and/or sheath 628. The clinician can initiate heating of the heated element 632 with the handpiece 616 (e.g., pushing the button 634). The heated element 632 can be heated to a temperature, which can at least include any of those described herein. The temperature sensor 643 can sense a temperature of the heated element 632, which can be used to automatically control the temperature of the heated element 632 (e.g., adjust current and/or voltage).
The heated element 632 can be advanced to contact the thrombus. The heat from the heated element 632 can ease penetration of the thrombus, which can include softening and/or emulsifying the thrombus (e.g., softening and/or emulsifying the core of the thrombus). In some variants, the heated element 632 can penetrate and cross over the thrombus without assistance from the guide wire 608. In some variants, the heated element 632 and guide wire 608 can cooperate to penetrate and/or cross the thrombus. For example, the heated element 632 may be advanced to contact the thrombus and apply heat to soften and/or emulsify the thrombus and then the guide wire 608 may be advanced to engage the thrombus.
With the heated element 632 and guide wire 608 crossed over the thrombus (e.g., positioned distally of the thrombus), the thermal assembly 602 can be retracted out of the vasculature through the lumen 660 of the tube 654 disposed inside the sheath 628. A capture device and/or cutting device can be advanced distally over the guide wire 608 and through the sheath 628 (e.g., tube 654 disposed inside the sheath 628). The capture device, which can at least include any of those described herein, can be disposed distally of the thrombus. The capture device can be expanded distally of the thrombus and retracted to capture and remove the thrombus, which can include removal through the lumen 660 of the tube 654 in the sheath 628. In some variants, a cutting device, which may include heated elements, can be introduced through the anchoring assembly 603 to fragment the thrombus for removal. The anchoring assembly 603 and/or guide wire 608 can be retracted proximally for removal.
The actions, steps, methods, etc. described herein can be performed by a clinician (e.g. surgeon) and/or robot.
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. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the systems and methods. 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.
Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.
Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, and all operations need not be performed, to achieve the desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
Conjunctive language, such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
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 thermal thrombectomy devices, systems, 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.
This application claims the priority benefit of U.S. Provisional Application No. 63/520,214, filed Aug. 17, 2023, and U.S. Provisional Application No. 63/481,900, filed Jan. 27, 2023, which are hereby incorporated by reference in their entireties. All applications for which a foreign or domestic priority is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
| Number | Date | Country | |
|---|---|---|---|
| 63520214 | Aug 2023 | US | |
| 63481900 | Jan 2023 | US |
