Thermal system and method for lens removal

Abstract

The present disclosure relates to a thermal emulsification system and method for cataract removal. The thermal emulsification system can apply heat to a lens of an eye, resulting in emulsification of the lens. The emulsified lens can be aspirated from the lens capsule of the eye. The thermal emulsification system can include one or more elements that can apply localized heat to the lens to heat it in a manner that avoids unintentional damage to other ocular components and cellular structures of the eye, such as the lens capsule. The thermal emulsification system can deliver a heated fluid to the lens to apply localized heat to the lens to avoid unintentional damage to other ocular components and cellular structures of the eye, such as the lens capsule.

Description

[Technical Field]

[0001] (cross reference) This application claims the benefit of priority to U.S. Provisional Application No. 63 / 530,443, filed August 2, 2023, and U.S. Provisional Application No. 63 / 442,058, filed November 30, 2023, both of which are incorporated herein by reference in their entireties. All applications for which domestic or foreign priority is identified in the Application Data Sheet filed herewith are incorporated herein by reference under 37 CFR 1.57.

[0002] The present disclosure relates to systems and methods for removing the eye's natural lens. [Background technology]

[0003] As the eye ages, proteins in the lens may begin to break down and clump together. This clumping of proteins can cause cloudy areas to form in the lens, known as cataracts, which can adversely affect vision. This condition can sometimes be addressed with cataract surgery, in which the cataractous lens is removed from the eye and an intraocular lens ("IOL") is implanted in its place. Summary of the Invention [Problem to be solved by the invention]

[0004] During cataract surgery, incisions may be made through the cornea (e.g., limbus) and / or sclera to access the interior of the eye. A phacoemulsification tool, which may be a phacoemulsification probe, may be inserted through the incision to apply ultrasound to the cataract, fragmenting it and aspirating the fragments from the eye. Ocular components and cellular structures (e.g., ocular organs) are delicate and can be easily damaged by ultrasonic energy. Therefore, a cataract removal solution that avoids unintentional damage to ocular components and cellular structures is desirable.

[0005] Furthermore, applying ultrasonic energy to the cataract and removing it by suction can take 10 minutes or more, which can be approximately 8 percent of the time required to perform cataract surgery, making it susceptible to safety issues that may include, at a minimum, capsule rupture, damage to the zonules, iris rupture, synovial uveitis, etc. Therefore, cataract removal solutions that reduce the time required to remove the cataract and / or facilitate cataract removal are desirable. Furthermore, cataract removal solutions that preserve the capsule are desirable. Furthermore, cataract removal solutions that reduce damage to surrounding ocular tissues (e.g., capsule, zonules, iris, etc.) are desirable. [Means for solving the problem]

[0006] The thermal systems (e.g., thermal emulsification systems) described herein may address at least one or more of the problems identified above. The thermal systems described herein can apply heat (e.g., localized heat, ultra-localized heat) to the lens to soften, melt, liquefy, emulsify, flow, and / or facilitate removal (e.g., aspiration) of the lens.

[0007] Exposure of the ocular lens to heat can emulsify (e.g., liquefy). Crystallins are the major structural proteins in the lens and may include at least α-crystallin and β-crystallin. Exposure of crystallins and / or other proteins, biopolymers, and / or other lens materials to heat can emulsify (e.g., liquefy). Exposure of the lens to temperatures of 64-70°C (e.g., to a heated element and / or heated fluid at 64-70°C) can emulsify. Exposure of the lens to 64-66°C for less than 5 minutes can begin to emulsify, leaving some fragments of the lens intact. Exposure of the lens to 66-68°C for 1-3 minutes can nearly completely emulsify, leaving some thread-like fragments of the lens intact that can be aspirated with a fine-gauge needle (e.g., an 18-22 gauge needle). Exposure of the crystalline lens to 68-70°C for less than one minute can completely emulsify the lens, which can then be aspirated using a fine-gauge needle (e.g., a 30-gauge needle). Therefore, 64-70°C can be a workable range for emulsifying the lens. 66-70°C can be a preferred range. If complete emulsification of the lens is desired in a short time (e.g., less than one minute), 68-70°C is more preferred, reducing the total amount of energy (e.g., joules) delivered to the eye compared to lower temperatures. For example, exposing the lens to 64-66°C (e.g., heated element and / or heated fluid) for five minutes can deliver more total energy to the eye compared to exposure to 68-70°C for less than one minute. Temperatures above 70°C unnecessarily expose the eye to more energy than is necessary to emulsify the lens. During testing, localized phase changes to a gaseous state were observed at temperatures above 70-80°C. Above 80°C, rapid phase changes to a gaseous state were observed instead of emulsification. The phase change to a gaseous state has been observed to damage (e.g., burn) peripheral structures of the eye (e.g., the lens capsule, zonules, etc.), which may include compromising the integrity of the lens capsule. Therefore, temperatures above 70°C should not be used. Although the lens may soften at temperatures below 64°C, temperatures below 64°C should not be used if emulsification is desired.The application of heat may be localized (e.g., hyperlocalized) to avoid unintended damage to ocular components (e.g., the lens capsule) and cellular structures, which may avoid damage that may occur with the application of ultrasound. Emulsification (e.g., liquefaction) of the lens may allow for clean separation of the lens (e.g., proteins, biopolymers, and other components of the lens) from the lens capsule.

[0008] The thermal system may include one or more elements (e.g., wires, contacts, mesh, loops, lassos, baskets, scoops, heating zones, heaters, heater cartridges, electrodes, etc.) that can be temperature controlled (e.g., regulated). For example, the temperature of one or more elements may be increased and / or decreased. The temperature of one or more elements may be adjusted based on suction and / or irrigation flow to compensate for convective losses (e.g., losses due to suction, irrigation, etc.). Heating of one or more elements may be achieved either directly or indirectly using various energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, etc. One or more elements may be located at the distal end of the thermal system such that the one or more elements can apply heat to the lens while the remainder of the system in contact with the patient's anatomy is insulated without or at least with reduced heat transfer. One or more elements may be used to first emulsify the nucleus / cortex of the lens or first emulsify the peripheral region of the lens. The temperature of one or more elements may be varied based on the density of the region of the lens (e.g., higher density regions may have higher temperatures, and lower density regions may have lower temperatures). For example, the nucleus / cortex may be denser than the peripheral region. Thus, the temperature of one or more elements may be higher for the nucleus / cortex compared to the peripheral region.

[0009] The thermal system may utilize a heated fluid (e.g., saline) to emulsify (e.g., liquefy) the lens of the eye. The thermal system may include an irrigation cannula (e.g., a tip) that can be introduced into the eye. The irrigation cannula may include an opening through which the heated fluid can flow into the lens. The heated fluid may quickly emulsify (e.g., liquefy) the lens for aspiration. The flow rate and / or pressure for irrigation and / or aspiration may be adjusted for speed and / or effectiveness during and after emulsification of the lens. The opening of the irrigation cannula and / or the corresponding aspiration opening may be adjusted in size for speed and / or effectiveness. The heated fluid may be used to penetrate and liquefy the nucleus / cortex of the lens first, or the peripheral region of the lens first. The temperature of the heated fluid may be varied based on the density of the region of the lens, as described herein. The heated fluid may be introduced into the lens capsule to emulsify the lens. In some variations, the emulsified lens and heated fluid can be aspirated as the heated fluid is introduced. In some variations, the emulsified lens and heated fluid can be irrigated with a cooler temperature fluid to emulsify the lens and then aspirated.

[0010] The thermal system may include an aspiration mechanism for aspirating the softened, melted, and / or emulsified lens from the eye. For example, the system may be incorporated into an aspiration tip (e.g., a phaco tip). The distal end of the aspiration tip may have localized elements (e.g., concentric rings, wires, individual contacts, etc.) for applying heat. The aspiration tip may be fluidly coupled to a system for supplying a heated fluid that can be directed to the lens. In some variations, The thermal system may include oscillating features, reciprocating features, retractable features, sharp distal tips, vibrating features, chomp features, grounding features, suction features, cryogenic features, temperature cycling features, etc. The thermal systems described herein may be retrofitted (e.g., coupled, attached, or integrated) into existing irrigation and / or aspiration devices, which may include positioning one or more heating elements on the distal tip of the existing device and / or fluidly coupling the system to provide heated fluid that can be directed toward the lens. The thermal emulsification system may be handheld and / or portable. The thermal system may include a rechargeable battery. The thermal emulsification system may include an irrigation receptacle (e.g., tank, compartment, bag) and / or an aspiration receptacle (e.g., tank, compartment, bag), which may or may not be disposable. One or more temperature control elements may include a nickel and titanium alloy (e.g., nitinol). In some variations, heating may be applied in conjunction with suction (e.g., to provide a heating / cooling cycle). In some variations, only the distal tip of the thermal system is heated, while the rest is damaged.

[0011] A thermal system can be used to remove the lens without significantly damaging the lens capsule and / or the zonules of the eye. For example, a small incision can be made in the lens capsule to access the lens within the capsule. A heated element and / or heated fluid can be introduced through the small incision to emulsify the lens. The emulsified lens can be aspirated through the same small incision or another small incision. With the lens removed, an intraocular lens can be placed into the lens capsule. In some variations, with the lens removed, a material (e.g., a gel) can be injected into the lens capsule. The material can fill the lens capsule. The material can include a refractive index that is the same as or at least similar to that of the natural lens.

[0012] In some variations, the technology described herein relates to an irrigation device. The irrigation device can include a tube including an outlet. The irrigation device can include a temperature sensor disposed at the outlet. The irrigation device can include a heater configured to heat fluid flowing through the irrigation device so that the temperature of the fluid at the outlet is within a specified range. The outlet of the tube can be directed toward the lens in the lens capsule of the eye to emulsify the lens.

[0013] In some variations, the technology described herein relates to irrigation devices with a specific range of 68-70°C.

[0014] In some variations, the technology described herein relates to an irrigation device that further includes a first fluid line that bypasses the heater and passes through the irrigation device.

[0015] In some variations, the technology described herein relates to an irrigation device that further includes a second fluid line that passes through the irrigation device and is wrapped around the heater.

[0016] In some variations, the technology described herein relates to an irrigation device that further includes a valve configured to direct fluid flow through the first fluid line or the second fluid line.

[0017] In some variations, the technology described herein relates to irrigation devices that include a spring that biases a valve into a configuration that directs fluid flow through the first fluid line.

[0018] In some variations, the technology described herein relates to an irrigation device that further includes a user interface configured to operate to overcome the biasing force of the spring and position the valve in another configuration that directs the flow of the fluid through the second fluid line.

[0019] In some variations, the technology described herein relates to irrigation devices in which a temperature sensor is placed within the lumen of a tube.

[0020] In some variations, the technology described herein relates to an irrigation device. The irrigation device can include a tube including an outlet capable of delivering fluid to a lens within the lens capsule of the eye. The irrigation device can include a first fluid line. The irrigation device can include a second fluid line. The irrigation device can include a heater capable of heating fluid flowing through the second fluid line. The irrigation device can include a valve capable of directing fluid through the first fluid line to bypass the heater or through the second fluid line for heating.

[0021] In some variations, the technology described herein relates to an irrigation device in which the heater is configured to heat the fluid so that the temperature of the fluid exiting the outlet is between 68 and 70°C.

[0022] In some variations, the technology described herein relates to an irrigation device in which a valve is biased to direct fluid flow through a first fluid line.

[0023] In some variations, the technology described herein relates to an irrigation device that further includes a user interface configured to operate to overcome the bias of the valve and direct fluid through the second fluid line.

[0024] In some variations, the technology described herein relates to irrigation devices in which the second fluid line is coiled around a heater.

[0025] In some variations, the technology described herein relates to an irrigation device that further includes a temperature sensor disposed at the outlet.

[0026] In some variations, the technology described herein relates to irrigation devices in which the heater is configured to adjust its energy output based on a temperature sensed by a temperature sensor.

[0027] In some variations, the technology described herein relates to an irrigation device. The irrigation device may include a tube with an outlet capable of delivering fluid to the lens within the capsular bag of the eye. The irrigation device may include a heater capable of heating the fluid so that the temperature of the fluid at the outlet is 68-70°C.

[0028] In some variations, the technology described herein relates to an irrigation device further including a temperature sensor at the outlet, wherein the heater is configured to adjust the energy output based on the temperature of the fluid at the outlet.

[0029] In some variations, the technology described herein relates to an irrigation device that includes a fluid line wrapped around a heater.

[0030] In some variations, the techniques described herein relate to a method for removing a lens from a capsular bag. The method can include positioning an outlet of an irrigation tube of an irrigation device at the nucleus of the lens within the capsular bag. The method can include positioning an inlet of an aspiration tube of an aspiration device proximate to the outlet of the irrigation tube. The method can include delivering a fluid heated to 68-70°C to the lens to emulsify the lens. The method can include aspirating the heated fluid and emulsified lens from the eye.

[0031] In some variations, the method can include heating the fluid. The method can include adjusting the heating of the fluid based on a sensed temperature of the heated fluid at the outlet of the irrigation tube.

[0032] In some variations, a thermal system for removing a lens from an eye is disclosed herein. The system can include a distal tip that can have a suction opening and / or a heating element. The distal tip can be inserted into the eye to position the heating element on the lens. The system can include a power source that can direct electrical energy to the heating element to increase the temperature of the heating element. The heating element can heat the lens to at least the lens's glass transition temperature so that the lens flows or softens, thereby facilitating suction through the suction opening.

[0033] In some variations, the system can include an irrigation port through which fluid can be irrigated into the eye.

[0034] In some variations, the heating element may be positioned around the suction opening.

[0035] In some variations, the heating element may include a ring shape.

[0036] In some variations, the heating element may include a plurality of discrete elements that may be distributed circumferentially around the suction opening.

[0037] In some variations, the heating element can be located on the distal-facing surface of the distal tip.

[0038] In some variations, the heating element may be retractable.

[0039] In some variations, the heating element may oscillate.

[0040] In some variations, the heating element may vibrate.

[0041] In some variations, the heating element may include a sharp tip.

[0042] In some variations, the heating element may include a cutting edge.

[0043] In some variations, the heating element may include a wire.

[0044] In some variations, the heating element may include a wire that forms a loop.

[0045] In some variations, the heating element may include multiple wires forming multiple loops.

[0046] In some variations, the heating element may include a mesh.

[0047] In some variations, the system can include a receptacle for receiving the aspirated lens.

[0048] In some variations, the distal end of the tip can be angled.

[0049] In some variations, the system may include insulation to protect the eyes.

[0050] In some variations, the temperature of the heating element can be varied cyclically.

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

[0052] In some variations, the power source can direct electrical energy to the heating element to raise the temperature of the heating element to 64-70°C.

[0053] In some variations, the power source can direct electrical energy to the heating element to raise the temperature of the heating element to 66-70°C.

[0054] In some variations, the power source can direct electrical energy to the heating element to raise the temperature of the heating element to 68-70°C.

[0055] In some variations, the power source can direct electrical energy to the heating element to heat the crystal to 64-70°C.

[0056] In some variations, the power source can direct electrical energy to the heating element to heat the lens to 66-70°C.

[0057] In some variations, the power source can direct electrical energy to the heating element to heat the lens to 68-70°C.

[0058] In some variations, the heating element can soften the lens.

[0059] In some variations, the heating element can emulsify the lens.

[0060] In some variations, the system may be a portable handheld device.

[0061] In some variations, a thermal system for cataract surgery is disclosed herein. The system can include a tip that can have a temperature-controlled element. The tip can be inserted into the eye and position the temperature-controlled element on the lens of the eye. The temperature-controlled element can heat the lens.

[0062] In some variations, the system can include an energy source capable of directing energy to the temperature control element to increase the temperature of the temperature control element.

[0063] In some variations, the energy source is a battery.

[0064] In some variations, the temperature control element can include a thermally conductive material.

[0065] In some variations, the system can include a suction opening through which the heated lens can be aspirated.

[0066] In some variations, the temperature control element can heat the lens to soften it.

[0067] In some variations, the temperature control element can heat the lens to emulsify the lens.

[0068] In some variations, the temperature control element can heat the lens to a glass transition temperature so that the lens flows.

[0069] In some variations, the temperature control element can heat the crystal to a melting temperature.

[0070] In some variations, the temperature control element can reach 64-70°C.

[0071] In some variations, the temperature control element can reach 66-70°C.

[0072] In some variations, the temperature control element can reach 68-70°C.

[0073] In some variations, the temperature control element is capable of heating the lens to 64-70°C.

[0074] In some variations, the temperature control element is capable of heating the lens to 66-70°C.

[0075] In some variations, the temperature control element is capable of heating the lens to 68-70°C.

[0076] In some variations, the system may include an irrigation port.

[0077] In some variations, the temperature control element can be located on the distal-facing surface of the tip.

[0078] In some variations, the temperature control element may be retractable.

[0079] In some variations, the temperature control element can oscillate.

[0080] In some variations, the temperature control element can vibrate.

[0081] In some variations, the temperature control element may include a sharp tip.

[0082] In some variations, the temperature control element may include a cutting edge.

[0083] In some variations, the temperature control element may include a wire, which may be retractable.

[0084] In some variations, the temperature control element can include a wire forming a loop.

[0085] In some variations, the temperature control element can include multiple wires forming multiple loops.

[0086] In some variations, the temperature control element may include a mesh.

[0087] In some variations, the system can include a receptacle for receiving the aspirated lens.

[0088] In some variations, the distal end of the tip is angled.

[0089] In some variations, the system may include thermal insulation to protect the eyes.

[0090] In some variations, the temperature control element may include a nickel and titanium alloy.

[0091] In some variations, the system may be a portable handheld device.

[0092] In some variations, disclosed herein is a temperature control element connected to an energy source that can direct energy to the temperature control element to increase the temperature of the temperature control element, and the temperature control element can be disposed on the suction device and positioned on the lens to heat the lens.

[0093] In some variations, the energy source may be a battery.

[0094] In some variations, the temperature control element may include an electrically conductive material.

[0095] In some variations, the temperature control element can heat the lens to soften it.

[0096] In some variations, the temperature control element can heat the lens to emulsify the lens.

[0097] In some variations, the temperature control element is capable of heating the lens to 64-70°C.

[0098] In some variations, the temperature control element is capable of heating the lens to 66-70°C.

[0099] In some variations, the temperature control element is capable of heating the lens to 68-70°C.

[0100] In some variations, the temperature control element can reach 64-70°C.

[0101] In some variations, the temperature control element can reach 66-70°C.

[0102] In some variations, the temperature control element can reach 68-70°C.

[0103] In some variations, the temperature control element may include a wire.

[0104] In some variations, methods for removing a lens are disclosed herein. The method can include inserting a tip of a thermal system into the eye and positioning a temperature control element at the lens. The method can include applying energy to the temperature control element to heat the lens. The method can include aspirating the heated lens.

[0105] In some variations, applying energy to the temperature control element to heat the lens can include raising the temperature of the lens to between 64 and 70°C.

[0106] In some variations, applying energy to the temperature control element to heat the lens can include raising the temperature of the lens to between 66 and 70 degrees Celsius.

[0107] In some variations, applying energy to the temperature control element to heat the lens can include raising the temperature of the lens to between 68 and 70 degrees Celsius.

[0108] In some variations, the temperature control element can heat to between 64 and 70°C. In some variations, the temperature control element can heat to between 66 and 70°C. In some variations, the temperature control element can heat to between 68 and 70°C.

[0109] In some variations, the energy may be electrical energy.

[0110] In some aspects, the technology described herein relates to a method for removing a lens, which can include passing a fluid at 64-70°C through the lens of the eye to emulsify the lens, and aspirating the emulsified lens from the eye.

[0111] In some embodiments, the technology described herein relates to a method, wherein the fluid is at 66-70°C.

[0112] In some embodiments, the technology described herein relates to a method, wherein the fluid is at 68-70°C.

[0113] In some aspects, the techniques described herein relate to methods that further include cutting the lens capsule of the eye to access the lens.

[0114] In some aspects, the technology described herein relates to a method, wherein cutting the lens capsule of the eye includes flowing a fluid through the lens capsule to cut the lens capsule.

[0115] In some aspects, the technology described herein relates to a method further comprising introducing an irrigation cannula into the eye and introducing an aspiration cannula into the eye, the irrigation cannula configured to flush fluid into the lens and the aspiration cannula configured to aspirate the emulsified lens from the eye.

[0116] In some aspects, the techniques described herein relate to methods further including positioning an irrigation cannula and an aspiration cannula on opposite sides of the optical axis, with the opening of the irrigation cannula facing the opening of the aspiration cannula.

[0117] In some aspects, the technology described herein relates to a method in which the irrigation cannula and the aspiration cannula are juxtaposed to one another such that the axes of the irrigation cannula and the aspiration cannula are parallel to one another.

[0118] In some aspects, the technology described herein relates to a method in which an irrigation cannula is placed inside a suction cannula.

[0119] In some aspects, the techniques described herein relate to methods further including the step of advancing a member through the irrigation cannula to engage the lens.

[0120] In some aspects, the technology described herein relates to a method further comprising the step of heating the member.

[0121] In some aspects, the technology described herein relates to a method, wherein the member is a wire.

[0122] In some aspects, the technology described herein relates to a method, wherein an irrigation cannula includes a closed end having one or more openings disposed through a sidewall.

[0123] In some aspects, the technology described herein relates to a method, wherein the closed end includes a curved perimeter.

[0124] In some aspects, the technology described herein relates to a method, wherein the closed end includes a curved inner surface.

[0125] In some aspects, the technology described herein relates to a method in which an irrigation cannula includes a curved portion configured to redirect fluid flow from a distal direction to a proximal direction.

[0126] In some aspects, the technology described herein relates to a method as set forth in 88, wherein the irrigation cannula includes a proximally facing opening.

[0127] In some aspects, the technology described herein relates to a method according to any of 78-84, wherein the irrigation cannula includes a flared portion that gradually increases the internal lumen of the irrigation cannula to the opening.

[0128] In some aspects, the technology described herein relates to a method according to any of 78-84, wherein the irrigation cannula includes a cutting edge disposed at its distal end.

[0129] In some aspects, the technology described herein relates to a method in which an aspiration cannula is placed inside an irrigation cannula.

[0130] In some aspects, the technology described herein relates to a method, wherein the aspiration cannula includes a closed end having one or more openings disposed in a sidewall.

[0131] In some aspects, the technology described herein relates to a method, wherein the aspiration cannula includes a cutting edge.

[0132] In some aspects, the technology described herein relates to a method in which a cutting edge is disposed around the distal opening of the aspiration cannula.

[0133] In some aspects, the technology described herein relates to a method, wherein the aspiration cannula includes a flared distal end.

[0134] In some aspects, the technology described herein relates to a thermal system for cataract surgery, the system including a tip configured to deliver a fluid at 64-70°C to the lens of the eye to emulsify the lens, and an opening configured to aspirate the emulsified lens from the eye.

[0135] In some embodiments, the technology described herein relates to a system, wherein the fluid is at 66-70°C.

[0136] In some embodiments, the technology described herein relates to a system, wherein the fluid is at 68-70°C.

[0137] In some aspects, the technology described herein relates to a system, wherein the system is a handheld device.

[0138] In some aspects, the technology described herein relates to a system, where the system is retrofitted to a phaco machine.

[0139] In some aspects, the technology described herein relates to systems that further include a fluid reservoir for holding the fluid prior to delivery.

[0140] In some aspects, the technology described herein relates to a system further including a heating element configured to heat the fluid.

[0141] In some aspects, the technology described herein relates to a system further including a temperature sensor.

[0142] In some aspects, the technology described herein relates to a system, wherein the temperature sensor is at the tip.

[0143] In some aspects, the technology described herein relates to a system, wherein a heating element is configured to adjust the temperature of a fluid based on a temperature detected by a temperature sensor.

[0144] In some aspects, the technology described herein relates to a system further including a pump.

[0145] In some aspects, the technology described herein relates to a system further including a valve configured to prevent delivery of the fluid.

[0146] In some aspects, the technology described herein relates to a system that further includes a waste reservoir configured to hold the aspirated material.

[0147] In some aspects, the technology described herein relates to a thermal system for cataract surgery, the system including a heating element configured to heat a fluid and deliver it to the lens of the eye at 64-70°C to emulsify the lens.

[0148] In some aspects, the technology described herein relates to a system, wherein a heating element is configured to heat a fluid and deliver it to the lens of the eye at 66-70°C.

[0149] In some aspects, the technology described herein relates to a system, wherein a heating element is configured to heat a fluid and deliver it to the lens of the eye at 68-70°C.

[0150] In some aspects, the technology described herein relates to a system further comprising a fluid reservoir.

[0151] In some aspects, the technology described herein relates to a system, wherein a heating element is configured to heat a fluid in a fluid reservoir.

[0152] In some aspects, the technology described herein relates to a system further including a temperature sensor, wherein the heating element is configured to adjust the temperature of the fluid based on feedback from the temperature sensor.

[0153] In some aspects, the technology described herein relates to a thermal system for cataract surgery that includes an irrigation cannula configured to deliver a fluid at 64-70°C to the lens of the eye to emulsify the lens, and an aspiration cannula configured to aspirate the emulsified lens from the eye.

[0154] In some aspects, the technology described herein relates to a system, wherein the irrigation cannula is configured to deliver fluid at 66-70°C.

[0155] In some aspects, the technology described herein relates to a system, wherein the irrigation cannula is configured to deliver fluid at 68-70°C.

[0156] In some aspects, the technology described herein relates to a system in which an irrigation cannula and an aspiration cannula are configured to be positioned on opposite sides of an optical axis, with the opening of the irrigation cannula facing the opening of the aspiration cannula.

[0157] In some aspects, the technology described herein relates to a system in which an irrigation cannula and an aspiration cannula are configured to be juxtaposed to one another such that the axes of the irrigation cannula and the aspiration cannula are parallel to one another.

[0158] In some aspects, the technology described herein relates to a system in which an irrigation cannula is positioned inside an aspiration cannula.

[0159] In some aspects, the technology described herein relates to systems that further include a member configured to be advanced through the irrigation cannula to engage the lens.

[0160] In some aspects, the technology described herein relates to a system, wherein a member is configured to be heated.

[0161] In some aspects, the technology described herein relates to a system, wherein the member is a wire.

[0162] In some aspects, the technology described herein relates to a system in which an irrigation cannula includes a closed end having one or more openings disposed through a sidewall.

[0163] In some aspects, the technology described herein relates to a system, wherein the closed end includes a curved perimeter.

[0164] In some aspects, the technology described herein relates to a system, wherein the closed end includes a curved inner surface.

[0165] In some aspects, the technology described herein relates to a system, wherein an irrigation cannula includes a curved portion configured to redirect the fluid flow from a distal direction to a proximal direction.

[0166] In some aspects, the technology described herein relates to the system of 128, wherein the irrigation cannula includes a proximally facing opening.

[0167] In some aspects, the technology described herein relates to a system in which an irrigation cannula includes a flared portion that gradually increases the internal lumen of the irrigation cannula to an opening.

[0168] In some aspects, the technology described herein relates to a system in which an irrigation cannula includes a cutting edge disposed at a distal end.

[0169] In some aspects, the technology described herein relates to a system in which an aspiration cannula is positioned inside an irrigation cannula.

[0170] In some aspects, the technology described herein relates to a system, wherein the aspiration cannula includes a closed end having one or more openings disposed in a sidewall.

[0171] In some aspects, the technology described herein relates to a system, wherein the aspiration cannula includes a cutting edge.

[0172] In some aspects, the technology described herein relates to a system in which a cutting edge is disposed about a distal opening of an aspiration cannula.

[0173] In some aspects, the technology described herein relates to a system, wherein the aspiration cannula includes a flared distal end.

[0174] Neither the foregoing summary nor the following detailed description is intended to limit or define the scope of protection, which is defined by the claims. [Brief explanation of the drawings]

[0175] The above and other features of the embodiments disclosed herein are described below with reference to the drawings of the embodiments. The illustrated embodiments are intended to illustrate, but not to limit, the scope of protection. Various features of different disclosed embodiments can be combined to form further embodiments that are part of this disclosure.

[0176] [Figure 1A] 1 shows a schematic diagram of the lens of the human eye. [Figure 1B] 1 shows a schematic diagram of the lens of the human eye. [Figure 1C] 1 shows a schematic diagram of the lens of the human eye. [Figure 1D] 1 shows a schematic diagram of the lens of the human eye.

[0177] [Figure 2] 1 illustrates the process of cataract formation.

[0178] [Figure 3A] 1 illustrates how to perform cataract surgery. [Figure 3B] 1 illustrates how to perform cataract surgery. [Figure 3C] 1 illustrates how to perform cataract surgery.

[0179] [Figure 4A] 1 illustrates how to perform cataract surgery. [Figure 4B] 1 illustrates how to perform cataract surgery. [Figure 4C] 1 illustrates how to perform cataract surgery.

[0180] [Figure 5A] 1 illustrates how to perform cataract surgery. [Figure 5B] 1 illustrates how to perform cataract surgery. [Figure 5C] 1 illustrates how to perform cataract surgery.

[0181] [Figure 6A] 1 illustrates how to perform cataract surgery. [Figure 6B] 1 illustrates how to perform cataract surgery. [Figure 6C] 1 illustrates how to perform cataract surgery. [Figure 6D] 1 illustrates how to perform cataract surgery.

[0182] [Figure 7] 7A and 7B illustrate a method for removing a lens containing a cataract.

[0183] [Figure 8] 1 shows a graph showing the glass transition temperature of a crystalline lens.

[0184] [Figure 9A] 1 shows a table of a lens with a cataract before and after application of heated fluid at different temperatures.

[0185] [Figure 9B] 1 shows a table of a lens with a cataract before and after application of heated fluid after different durations.

[0186] [Figure 9C] 1 shows a diagram of a lens with a cataract before and after application of heated fluid.

[0187] [Figure 9D] Figure 9D-1 shows a lens with a cataract placed within the lens capsule, and Figure 9D-2 shows the intact lens capsule after the lens has been emulsified with heated fluid and aspirated.

[0188] [Figure 10] 1 shows a thermal system.

[0189] [Figure 11] 1 shows a thermal system used to remove a lens having a cataract.

[0190] [Figure 12] 1 shows the tip of a thermal system with a temperature control element.

[0191] [Figure 13] 1 shows the tip of a thermal system with a temperature control element.

[0192] [Figure 14A] 1 shows the tip of a thermal system with a retractable temperature control element. [Figure 14B] 1 shows the tip of a thermal system with a retractable temperature control element. [Figure 14C] 1 shows the tip of a thermal system with a retractable temperature control element.

[0193] [Figure 15A] 1 shows a temperature control loop for a thermal system. [Figure 15B] 1 shows a temperature control loop for a thermal system.

[0194] [Figure 15C] 1 illustrates multiple temperature control loops for a thermal system.

[0195] [Figure 16] 1 shows a temperature control mesh for a thermal system.

[0196] [Figure 17] 1 shows a schematic diagram of a handheld system for applying heated fluid to a lens.

[0197] [Figure 18] 1 shows a schematic diagram of a phaco system having features for applying heated fluid to the lens.

[0198] [Figure 19(1)] 1 shows a schematic diagram of a system for supplying heated fluid for emulsifying lenses. [Figure 19(2)] 1 shows a schematic diagram of a system for supplying heated fluid for emulsifying lenses.

[0199] [Figure 20A] 1 shows an irrigation tip applying heated fluid to the lens of the eye and an aspiration tip aspirating the emulsified lens, the irrigation tip and the aspiration tip positioned such that the distal openings of the irrigation tip and the aspiration tip generally face each other. [Figure 20B] 1 shows an irrigation tip applying heated fluid to the lens of the eye and an aspiration tip aspirating the emulsified lens, the irrigation tip and the aspiration tip positioned such that the distal openings of the irrigation tip and the aspiration tip generally face each other. [Figure 20C] 1 shows an irrigation tip applying heated fluid to the lens of the eye and an aspiration tip aspirating the emulsified lens, the irrigation tip and the aspiration tip positioned such that the distal openings of the irrigation tip and the aspiration tip generally face each other.

[0200] [Figure 21A] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and the aspiration tip positioned adjacent to each other with their longitudinal axes parallel to each other. [Figure 21B]1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and the aspiration tip positioned adjacent to each other with their longitudinal axes parallel to each other. [Figure 21C] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and the aspiration tip positioned adjacent to each other with their longitudinal axes parallel to each other.

[0201] [Figure 22A] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially. [Figure 22B] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially. [Figure 22C] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially. [Figure 22D] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially. [Figure 22E] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially. [Figure 22F] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially. [Figure 22G] 1 shows an irrigation tip that applies heated fluid to the lens of the eye and an aspiration tip that aspirates the emulsified lens, the irrigation tip and aspiration tip being positioned coaxially.

[0202] [Figure 22H] Irrigation tip shown.

[0203] [Figure 23A] 1 shows an aspiration tip with a heated element. [Figure 23B] 1 shows an aspiration tip with a heated element. [Figure 23C] 1 shows an aspiration tip with a heated element. [Figure 23D] 1 shows an aspiration tip with a heated element.

[0204] [Figure 24] An irrigation tip (e.g., cannula) is shown. [Figure 25A] An irrigation tip (e.g., cannula) is shown. [Figure 25B] An irrigation tip (e.g., cannula) is shown. [Figure 25C] An irrigation tip (e.g., cannula) is shown. [Figure 26A] An irrigation tip (e.g., cannula) is shown. [Figure 26B] An irrigation tip (e.g., cannula) is shown. [Figure 27] An irrigation tip (e.g., cannula) is shown. [Figure 28] An irrigation tip (e.g., cannula) is shown. [Figure 29A] An irrigation tip (e.g., cannula) is shown. [Figure 29B] An irrigation tip (e.g., cannula) is shown.

[0205] [Figure 30] An aspiration tip (e.g., cannula) is shown. [Figure 31] An aspiration tip (e.g., cannula) is shown. [Figure 32] An aspiration tip (e.g., cannula) is shown. [Figure 33] An aspiration tip (e.g., cannula) is shown.

[0206] [Figure 33A] 1 shows an irrigation handpiece. [Figure 33B] 1 shows an irrigation handpiece.

[0207] [Figure 34A] 1 shows an irrigation handpiece. [Figure 34B] 1 shows an irrigation handpiece.

[0208] [Figure 35A] 1 shows a suction handpiece. [Figure 35B] 1 shows a suction handpiece.

[0209] [Figure 36A] 1 shows tips for irrigation and / or aspiration handpieces. [Figure 36B] 1 shows tips for irrigation and / or aspiration handpieces.

[0210] [Figure 37] 1 shows a schematic diagram of an irrigation system.

[0211] [Figure 38] 1 shows a schematic diagram of an irrigation system.

[0212] [Figure 39] 1 shows a schematic diagram of an aspiration system.

[0213] [Figure 40] 1 shows a schematic diagram of an aspiration system.

[0214] [Figure 41A] 1A-1C show schematic diagrams of an irrigation handpiece with temperature sensors in different locations. [Figure 41B] 1A-1C show schematic diagrams of an irrigation handpiece with temperature sensors in different locations. [Figure 41C] 1A-1C show schematic diagrams of an irrigation handpiece with temperature sensors in different locations.

[0215] [Figure 42]1 shows a temperature sensor located in the irrigation tubing of an irrigation handpiece.

[0216] [Figure 43A] Shown are an IV pole for supporting an irrigation system and / or aspiration system, a reservoir for fluids (eg, an IV bag), a separator (eg, a vacuum canister), a wall vacuum, and a console.

[0217] [Figure 43B] Indicates the console.

[0218] [Figure 44A] 1 shows irrigation and aspiration tubes positioned on the lens of the eye. [Figure 44B] 1 shows irrigation and aspiration tubes positioned on the lens of the eye.

[0219] [Figure 44C] Shown are irrigation tubing that delivers heated fluid to the lens to emulsify the lens, and aspiration tubing that aspirates the heated fluid and emulsified lens. DETAILED DESCRIPTION OF THE INVENTION

[0220] Although specific embodiments and examples are described below, the disclosure extends beyond the specifically disclosed embodiments and / or uses as well as obvious modifications and equivalents thereof, and therefore it is not intended that the scope of the disclosure should be limited by any particular embodiments described below.

[0221] 1A-1D show schematic diagrams of the lens of the human eye. As shown, the lens of the human eye can include a nucleus in the central region of the eye. The lens can include a lens cortex radially outward from the nucleus. The lens can include a posterior subcapsular region radially outward from the lens cortex. As shown in FIG. 1C, the lens can be disposed inside a capsule, which can be referred to as the lens capsule. The lens can include a lens epithelium disposed anteriorly. The lens can include a cortex radially inward from the epithelium, an adult nucleus radially inward from the cortex, a juvenile nucleus radially inward from the adult nucleus, a fetal nucleus radially inward from the juvenile nucleus, and an embryonic nucleus radially inward from the embryonic nucleus. A diagram of the cell populations in various regions of the lens is shown in FIG. 1D.

[0222] As the eye ages, proteins (e.g., crystallins) and / or biopolymers in the lens may begin to degrade and clump together. This protein clumping can lead to the formation of cloudy areas in the lens called cataracts, which can adversely affect vision. Figure 2 shows a schematic diagram of the cataract formation process.

[0223] 3A-3C illustrate a method for performing cataract surgery. As shown in FIG. 3A, an eye 100 includes a lens capsule 110 having a lens 112 behind an iris 104. The lens capsule 110 is attached to the ciliary muscle 108 of the eye 100 via a zonules 106.

[0224] As described herein, proteins and / or biopolymers, such as crystallins, can clump together and cloud the lens 112, causing cataracts that impair vision. To improve vision, cataract surgery may be performed. To perform cataract surgery, an incision may be made in the cornea 102 (e.g., the limbus) and / or the sclera 142 to access the interior of the eye. For example, a diamond knife tool 116 having a diamond knife 118 may be used to cut small incisions in the cornea 102 and / or the sclera 142.

[0225] 3B , the phacoemulsification needle tool 128 may be advanced to position the tip 130 through an incision in the cornea 102 and / or sclera 142. The phacoemulsification needle tool 128 may apply ultrasonic energy to the capsule 110 and / or cut through the capsule 110 with a cutting edge to create an opening 136 (e.g., an anterior opening) in the capsule 110 to access the lens 112. The phacoemulsification needle tool 128 may apply ultrasonic energy to the lens 112 via the tip 130 to emulsify the lens 112. The emulsified portion 114 of the lens 112 may be aspirated (e.g., vacuum suctioned) from the capsule 110 of the eye 100.

[0226] With the lens 112 removed, an intraocular lens (IOL) 138 may be inserted through the incision in the cornea 102 and / or sclera 142 and the opening 136 to position the intraocular lens 138 within the lens capsule 110, as shown in FIG. 3C . The intraocular lens 138 may include haptics 140 that contact the lens capsule 110, which may include contacting the equatorial region of the lens capsule 110. With the lens 112 removed, placing the intraocular lens 138 in its position may improve the vision of the eye 100. The intraocular lens 138 may be monofocal or accommodating. The intraocular lens 138 may include a toric feature to address astigmatism.

[0227] 4A-4C illustrate a method of performing cataract surgery. As shown in FIG. 4A, a crescent knife tool 120 having a crescent knife 122 may be used to cut an incision in the cornea 102 (e.g., limbus) and / or sclera 142. The incision from the crescent knife tool 120 may be larger than the incision made by the diamond knife tool 116 described with reference to FIGS. 3A-3C. As shown in FIG. 4B, a lens expression loop tool 132 may be advanced to position a loop 134 through the incision in the cornea 102 and / or sclera 142. The lens expression loop tool 132 may create (e.g., cut) an opening 136 in the lens capsule 110 to access the lens 112. The loop 134 may cut (e.g., fragment) and / or capture the lens 112. The loop 134 may capture the lens 112 and retract through the opening 136 and incision to remove the lens 112. With the lens 112 removed, an intraocular lens 138 may be inserted through the incision in the cornea 102 and / or sclera 142 and the opening 136 to position the intraocular lens 138 within the lens capsule 110. With the lens 112 removed and the intraocular lens 138 in its place, the vision of the eye 100 may be improved.

[0228] 5A-5C illustrate a method of performing cataract surgery. As shown in FIG. 5A, a laser tool 124 may use a laser 126 (e.g., a femtosecond laser) to create an incision in the cornea 102 and / or sclera 142. The laser tool 124 may use the laser 126 to perform an initial fragmentation of the lens 112 and / or create an opening 136 in the lens capsule 110. The laser tool 124 may include a fixation tool. A tip 130 of a phacoemulsification needle tool 128 may be inserted through the incision in the cornea 102 and / or sclera 142 and apply ultrasonic energy to the lens 112 to emulsify the lens 112. The emulsified portion 114 of the lens 112 may be aspirated from the lens capsule 110. With the lens 112 removed, an intraocular lens 138 may be inserted through the incision in the cornea 102 and / or sclera 142 and through the opening 136 to position the intraocular lens 138 within the lens capsule 110. With the lens 112 removed and the intraocular lens 138 in its place, the vision of the eye 100 may be improved.

[0229] 6A-6C illustrate a method of performing cataract surgery. As shown in FIG. 6A, a blade 117 can be used to create (e.g., cut) an incision 148 in the cornea 102 (e.g., limbus) and / or sclera 142. As shown in FIG. 6B, a phacoemulsification needle tool 128 can be inserted through the incision 148 so that ultrasonic energy can be applied to the clouded lens 112 by the tip 130. Ultrasonic energy can be applied to the anterior portion of the lens capsule 110 to form an opening 136. The ultrasonic energy applied to the lens 112 can emulsify the lens 112. The phacoemulsification needle tool 128 can include features for aspirating the emulsified lens 112 from the lens capsule 110. For example, the tip 130 can include an opening 150 through which the emulsified lens 112 can be aspirated (e.g., vacuum aspirated). The phacoemulsification needle tool 128 may include an irrigation port 146 through which fluid (e.g., saline) may enter the eye 100 to maintain the anterior chamber of the eye 100. With the lens 112 from which the cataract has been removed, an intraocular lens 138 may be placed within the capsule 110 by placing it through an incision 148 in the cornea 102 and / or sclera 142, as shown in FIG. 6C, and through the opening 136 in the capsule 110, as shown in FIG. 6D. With the lens 112 removed, placing the intraocular lens 138 in its place may improve the vision of the eye 100.

[0230] 7A shows a phacoemulsification needle tool 128 inserted through an incision in the cornea 102 and / or sclera 142 such that the tip 130 is positioned on the lens 112. As will be described, ultrasonic energy may be applied to the tip 130 to emulsify the lens 112. The emulsified lens 112 may be aspirated through an opening in the tip 130. Fluid (e.g., balanced saline) may exit an irrigation port 146 of the phacoemulsification needle tool 128 to maintain the anterior chamber of the eye 100.

[0231] 7B shows the phacoemulsification needle tool 128 inserted through an incision 148 in the cornea 102 and / or sclera 142 such that the tip 130 is positioned through the opening 136 in the capsular bag 110 to be disposed on the lens 112. As will be described, ultrasonic energy may be applied to the tip 130 to emulsify the lens 112. The emulsified lens 112 may be aspirated through an opening 150 in the tip 130. Fluid (e.g., saline) may exit the irrigation port 146 of the phacoemulsification needle tool 128 to maintain the anterior chamber of the eye 100.

[0232] (Temperature range) As described herein, crystallins are the major structural proteins in the lens 112 and may include at least α-crystallin and β-crystallin. The lens 112 may flow at a glass transition temperature. The proteins and / or biopolymers of the lens 112 may flow at a glass transition temperature. The lens 112 may melt at a melting temperature. The proteins and / or biopolymers of the lens 112 may melt at a melting temperature higher than the glass transition temperature. Heat may be applied to a thermal system (e.g., a thermal emulsification system) described herein to raise the temperature of the lens 112 (e.g., one or more proteins, biopolymers, and / or other components of the lens 112) to a glass transition temperature to soften the lens 112 (e.g., one or more proteins, biopolymers, and / or other components of the lens 112) and / or to a melting temperature to melt (e.g., emulsify, liquefy) the lens 112 (e.g., one or more proteins, biopolymers, and / or other components of the lens 112). In some variations, heat may be applied to a thermal system described herein to raise the temperature of the lens 112 between the glass transition temperature and / or melting temperature. As described herein, one or more elements (e.g., contacts, heating elements, wires, loops, meshes, baskets, tips, etc.) and / or fluid (e.g., saline) can be heated to at least the glass transition temperature of the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112), the melting temperature of the lens 112 (e.g., one or more proteins, biopolymers, and / or other components of the lens 112), and / or the glass transition temperature and / or melting temperature of the lens 112. The fluid may be any suitable for ocular treatment (e.g., saline, balanced salt solution, 0.9% saline, pharmaceutical drops, viscoelastic, etc.). Heating the lens 112 to the glass transition temperature and / or melting temperature of the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may facilitate removal (e.g., aspiration) of the lens 112 from the lens capsule 110.One or more elements and / or fluids can provide localized heat (e.g., ultra-localized heat) to the lens 112, thereby avoiding damage to other portions of the eye 100.

[0233] FIG. 8A shows an exemplary graph depicting stiffness / elastic modulus (MPa) versus temperature (k) of the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112). As shown, the glass transition temperature (Tg) at which the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may reach a glass transition. FIG. 8B shows an exemplary graph depicting the specific volume of the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) versus temperature. Again, the glass transition temperature (Tg) at which the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may reach a glass transition. When heated to the glass transition temperature, the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may change from a first state (e.g., a hard, glassy state) to a second state that is softer than the first state, and the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) begins to flow. When heated to the glass transition temperature, the viscosity of the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may decrease.

[0234] The lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may be emulsified at a temperature above its glass transition temperature (e.g., melting temperature), which may be described as being liquefied. Once the lens 112 (e.g., proteins, biopolymers, and / or other components) is emulsified, the lens 112 may be more efficiently removed from the eye (e.g., from the lens capsule). For example, the lens 112 may be removed by emulsification and aspiration much more quickly compared to previous methods, which may involve emulsification and aspiration of the lens within a few seconds, less than one minute, or less than two minutes. Furthermore, the liquefied lens may be aspirated with less invasive techniques (e.g., fine-gauge needles, which may include at least a gauge of 16, 18, 19, 20, 21, 22, 23, 25, 26, 27, 29, 30, etc.) compared to conventional techniques. The lens 112 may be emulsified by exposure to a heated element (e.g., a wire, tip, etc.). The lens 112 can be emulsified by exposing it to a heated fluid (eg, saline).

[0235] Experiments have revealed different effects on the lens by exposing it to heat sources of different temperature ranges. For example, Figure 9A shows a table of results from exposing a human lens 112 with cataracts to fluids (e.g., saline) heated to different temperature ranges. As shown, when the lens 112 was exposed to fluids below 64°C for 8-10 minutes, no significant emulsification of the lens 112 was observed, although softening of the lens may occur.

[0236] After exposing the lens 112 to the 64-66°C fluid for less than 5 minutes, the lens 112 began to emulsify. Additional mechanical support (e.g., mechanical agitation with one or more surgical tools) was used to break up the remaining fragments 113 of the lens 112.

[0237] Exposing the lens 112 to the 66-68°C fluid for 1-3 minutes resulted in a nearly complete emulsification of the lens, with some loose thread-like fragments 113 still present, which could be aspirated with a fine gauge needle (e.g., an 18-22 gauge needle). Some additional minor mechanical support (e.g., mechanical agitation with one or more surgical tools) was used to assist in breaking up the lens fragments.

[0238] Exposing the lens 112 to the 68-70°C fluid for less than 1 minute emulsifies (e.g., completely emulsifies) the lens, which can be aspirated with a fine gauge needle (e.g., 30 gauge). No mechanical support was used to assist in breaking up the lens.

[0239] Temperatures above 70°C unnecessarily expose the eye to more energy than is necessary to emulsify the lens. During testing, localized phase changes to a gaseous state were observed when the lens was exposed to fluids at temperatures above 70°C-80°C. Above 80°C, instead of emulsification, a rapid phase change to a gaseous state was observed. The phase change to a gaseous state was observed to damage (e.g., burns) peripheral structures of the eye (e.g., lens capsule, zonules).

[0240] FIG. 9B shows a table of the results of exposing a human lens 112 with cataracts to a fluid (e.g., saline) heated to 68-70°C. As shown, the lens 112 begins to emulsify after the first few seconds, with some fragments 113 observed to separate. After approximately 30 seconds, significant emulsification of the lens 112 is observed, with the majority of the lens 112 breaking down into loose fragments 113. Approaching one minute, the lens 112 is observed to be nearly completely emulsified, with only a few loose fragments 113 remaining. At approximately one minute, the lens 112 is observed to be completely emulsified. At approximately two minutes, the lens 112 is observed to be completely emulsified.

[0241] 9C shows a table of results from exposing a human lens 112 with cataracts to a fluid (e.g., saline) heated to 68-70° C. As shown, the lens 112 was observed to completely emulsify in less than two minutes.

[0242] 9D-1 and 9D-2 show an ex vivo surgical simulation performed on a cadaver eye 100, in which a lens 112 is emulsified with a fluid heated to 68-70°C and removed by suction in less than two minutes. FIG. 9D-1 shows a lens 112 with a cataract placed within the eye 100, with an irrigation tube 900 (e.g., an irrigation device, an irrigation tip, an irrigation cannula) and an aspiration tube 902 (e.g., an aspiration device, an aspiration tip, an aspiration cannula) positioned to emulsify and aspirate the lens 112. The irrigation tube 900 is positioned within the eye 100 through the cornea 102, with an outlet 908 of the irrigation tube 900 positioned at the lens 112. The aspiration tube 902 is positioned within the eye 100 through the cornea 102, with an inlet 910 of the aspiration tube 902 positioned at the lens 112. Fluid heated to 68-70°C was directed through outlet 908 of irrigation tube 900 onto lens 112, emulsifying lens 112. The heated fluid and emulsified lens 112 were aspirated from capsule 110 through inlet 910 of aspiration tube 902. Inlet 910 of aspiration tube 902 was positioned close to outlet 908 of irrigation tube 900 to rapidly aspirate the heated fluid and emulsified lens 112 and to aid in localizing the heat from the heated fluid exiting irrigation tube 900.

[0243] FIG. 9D-2 shows the eye 100 after the lens 112 has been emulsified by the heated fluid flowing from the irrigation tube 900 at 68-70°C and aspirated by the aspiration tube 902. As shown, the lens capsule 110 remained intact after removal of the lens 112. As shown, the irrigation tube 900 and aspiration tube 902 accessed the lens 112 through an opening 136 (e.g., capsulorhexis) in the lens capsule 110, which remained intact after removal of the lens 112. Maintaining the integrity of the lens capsule 110 can be beneficial for many reasons, including IOL implantation and / or function. As described herein, maintaining the integrity of the lens capsule 110 can be beneficial for filled-bag IOLs, in which a gel and / or fluid is inserted into the capsule 110 as an artificial lens to replace the lens 112.

[0244] Identifying the effects of different temperature ranges on the lens was a key discovery for the successful implementation of the systems and methods described herein. As detailed herein, exposing the lens 112 to fluid heated to 68-70°C for less than one or two minutes results in complete emulsification. Thus, while flowing fluid above 70°C into the eye can completely emulsify the lens, it unnecessarily exposes the eye to more energy than is required to efficiently emulsify the lens. As detailed above, a phase change to a gaseous state is observed above 70°C, and this phase change to a gaseous state has been observed to damage (e.g., burn) peripheral structures of the eye (e.g., the lens capsule, zonules, etc.). Therefore, fluids introduced into the eye should not exceed 70°C. As detailed herein, exposing the lens to fluid at 66-68°C results in nearly complete emulsification, although some fragments of the lens (e.g., loose, thread-like fragments) remain intact and small enough to be aspirated through a fine-gauge needle. Thus, it has been newly discovered that introducing a fluid at 66-70°C is a preferred range for emulsifying the crystalline lens of the eye. That is, if complete emulsification of the crystalline lens is desired within a short duration (e.g., less than 1 minute, less than 2 minutes), it is preferable to introduce the fluid at 68-70°C. Nevertheless, introducing a fluid at 64-66°C is also effective because the crystalline lens begins to emulsify within that temperature range, but this temperature range requires a suction device with a larger opening to aspirate larger fragments compared to a suction device used when using a fluid at 66-70°C or even 68-70°C. However, a temperature range of 66-70°C and / or 68-70°C may be preferred to reduce the total amount of energy (e.g., joules) delivered to the eye compared to a lower temperature range, such as 64-66°C. For example, exposing the lens to a fluid (e.g., a heated element and / or heated fluid) at 64-66°C for 5 minutes can impart more total energy to the eye compared to exposing the eye to 68-70°C for less than 1 minute, which may make it desirable to expose the eye to less total energy. No significant emulsification of the lens 112 was observed when utilizing fluid at temperatures below 64°C.Therefore, it has been newly discovered that introducing the fluid at 64-70°C is a workable range for emulsifying the lens. However, if it is desired to soften the lens rather than liquefy it, temperatures below 64°C can be used.

[0245] The systems and methods described herein can use different temperatures when emulsifying different portions of the lens. For example, the nucleus / cortex of the lens is denser than the peripheral portion of the lens. Therefore, a higher temperature (e.g., closer to or at 70°C) may be employed when liquefying the nucleus / cortex compared to the peripheral portion of the lens. In some variations, the systems described herein can automatically adjust the temperature as the heating element and / or irrigation cannula (e.g., tip) navigates around the lens 112 to compensate for the change in density. In some variations, the surgeon can adjust the temperature as the heating element and / or irrigation cannula navigates around the lens to compensate for the change in density.

[0246] In some variations, emulsifying the lens using a heated fluid may be preferable to using a heated element. Heated fluids may have fewer heat loss issues compared to heated elements due to the influx of fresh heated fluid and rapid aspiration. Heated fluids may provide a larger contact area compared to heated elements.

[0247] Systems and Methods Comprising a Tip Having One or More Temperature Control Elements Described herein are systems and methods including a tip having one or more temperature-controlling elements that can apply localized heat to the lens instead of or in addition to using a heated fluid to emulsify or soften the lens. For example, FIG. 10 illustrates a thermal system 200 (e.g., a thermal emulsification system, device, or device). The thermal system 200 may be used to soften and / or emulsify the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) of the eye 100. The thermal system 200 may be used to aspirate the softened and / or emulsified lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112). The thermal system 200 may irrigate the eye 100 to maintain the anterior chamber. The thermal system 200 may be a portable, handheld device. In some variations, the thermal features of the thermal system 200 may be incorporated into existing aspiration and / or irrigation devices.

[0248] The thermal system 200 may include a tip 202 (e.g., a distal tip, tip, end, tube). The temperature of the tip 202 of the thermal system 200 may be controlled, including increasing (e.g., heating) and / or decreasing (e.g., cooling) the temperature of the tip 202. The tip 202 may include one or more temperature control elements 204 (e.g., localized heating zones), which may be heated and / or cooled. The one or more temperature control elements 204 may be positioned on or angled at a distal surface (e.g., distal face) of the tip 202. The one or more temperature control elements 204 may include various configurations, which may include at least a ring shape, discrete circumferentially positioned elements, and / or other configurations. The one or more temperature control elements 204 may be heated, either directly or indirectly, using various energy sources, which may include at least heat, radio frequency, laser, electricity (e.g., current), resistive heating, inductive heating, etc. The temperature control element 204 may include a metal, such as a metal alloy (e.g., a nickel and titanium alloy), to transfer heat to the lens 112. The temperature control element 204 allows the thermal system 200 to apply heat to the lens 112 in a localized, targeted manner while avoiding damage to other features of the eye 100. The tip 202 includes a circular periphery. The tip 202 can include a periphery of various shapes, which can include at least an ellipse, a polygon (e.g., a triangle, a square, a pentagon, etc.), an irregular shape, and / or the like. The tip 202 can be a tube.

[0249] The thermal system 200 may include hardware 210 that enables the thermal system 200 to perform the methods described herein. The hardware 210 may include a power source (e.g., a battery, a rechargeable battery, a disposable battery), a power interface (e.g., an interface for connecting to a wired power source), a temperature control unit, a suction control unit, an irrigation control unit, a controller, a processor, a wireless communication interface, a wired communication interface, memory, etc. The hardware 210 may be located at a proximal end of the thermal system 200. The hardware 210 may be distributed along the length of the thermal system 200. The thermal system 200 may include a housing 212 for housing the hardware 210 and / or other components of the thermal system 200. The housing 212 may include an insulating material to protect the patient from heat. In some variations, the housing 212 may include a neck portion 206 proximal to the tip 202 that includes insulating properties that can protect the patient from heat.

[0250] The temperature control unit may control temperature generation and / or modulation. The control unit may control the amount of energy directed to the temperature control elements 204 to regulate the temperature of the temperature control elements 204, which may include adjusting the energy provided to the temperature control elements 204 by the power supply and / or via the power supply interface. The temperature control unit may maintain one or more temperature control elements 204 at a temperature, increase the temperature, decrease the temperature, cycle the temperature, regulate the temperature based on sensor input (e.g., the temperature detected at the tip 202), etc.

[0251] The suction control unit may control the suction. For example, the tip 202 may include an opening 203 through which the softened and / or emulsified lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112) may be aspirated (e.g., vacuum suction). The suction control unit may start and stop suction through the opening 203. In some variations, the temperature control elements 204 may be disposed about the opening 203, which may include being distributed circumferentially around the opening 203.

[0252] An irrigation control unit may control the irrigation. The thermal system 200 may include a port through which a fluid (e.g., saline) can enter the eye 100. The fluid may maintain the anterior chamber of the eye 100 while the lens 112 is removed.

[0253] The thermal system 200 may include one or more user interfaces (e.g., buttons, dials, switches, displays, touchpads, touchscreens, knobs, triggers, indicators, gauges, and / or sliders) to allow a user (e.g., a surgeon) to control the thermal system 200, which may include at least activating the thermal system 200, activating the thermal system 200, heating one or more temperature control elements 204, cooling one or more temperature control elements 204, starting and / or stopping suction, and starting and / or stopping irrigation. In some variations, a user may set the temperature of one or more temperature control elements 204. In some variations, a user may adjust (e.g., increase, decrease) vacuum power for suction. In some variations, a user may adjust (e.g., increase, decrease) fluid flow for irrigation.

[0254] The thermal system 200 may include one or more receptacles 208 (e.g., bags) that may be disposed inside the housing 212. The one or more receptacles 208 may hold material aspirated from the eye 100. The one or more receptacles 208 may hold fluid (e.g., saline) for irrigation. The one or more receptacles 208 may be disposable.

[0255] The thermal system 200 may communicate with the computing device via wired or wireless communication.

[0256] FIG. 11 shows the thermal system 200 in use. The tip 202 of the thermal system 200 is advanced through an incision in the cornea 102 and / or sclera 142 and positioned against the lens 112. The tip 202 (e.g., one or more temperature control elements 204) is heated to soften and / or emulsify the lens 112 (e.g., proteins, biopolymers, and / or other components of the lens 112). The softened and / or emulsified lens 112 is aspirated through an opening 203 in the tip 202 and into one or more receptacles 208. Irrigation ports 214 allow fluid (e.g., saline), which may be stored in the one or more receptacles 208, to flow into the eye 100 to maintain the anterior chamber. As will be described, the heated tip 202 may apply heat to the lens 112 in a locally targeted manner, thereby avoiding damage to other portions of the eye 100. Softening and / or emulsification of the lens 112 can facilitate more rapid aspiration of the lens 112 compared to applying ultrasound, which can improve the safety and efficiency of cataract surgery.

[0257] FIG. 12 illustrates an exemplary tip 202. As described, the temperature of the tip 202 may be controlled. For example, the tip 202 may include one or more temperature control elements 204 (e.g., heating elements, contacts, leads, etc.) that can be heated or cooled. One or more temperature control elements 204 may be disposed at a distal end 252 (e.g., a distal surface, a distally-facing surface, etc.) of the tip 202. The distal end 252 may be angled. The tip 202 may include multiple temperature control elements 204. The temperature control elements 204 may be distributed around the opening 203 of the tip 202. The temperature control elements 204 may each have a circular shape, but may also have other shapes, which may include at least an oval, a polygon (e.g., a triangle, a square, a rectangle, a pentagon, etc.), an irregular shape, and / or the like. The temperature control element 204 may be heated to at least the temperatures described herein to soften and / or emulsify the lens 112 of the eye 100. The softened and / or emulsified lens 112 may be drawn through the opening 203 and into a channel 254 that may be fluidly connected to the receptacle 208.

[0258] 13 shows the tip 202. The tip 202 may include a temperature control element 204 having a ring shape, and the temperature control element 204 may be disposed at the distal end 252. The ring shape of the temperature control element 204 may be disposed around the opening 203. The temperature control element 204 may be disposed on the outer periphery of the opening 203. The ring shape may have a thickness that varies radially.

[0259] FIG. 14A shows a tip 202 (e.g., a tube, a cylinder, a conduit). In some variations, the thermal system 200 may include a member 246 (e.g., a wire, a nitinol wire, a tube). The member 246 may be temperature controlled (e.g., heated, cooled) as described herein. A distal end 250 of the member 246 (e.g., a wire) may be deployed from inside the tip 202 to soften and / or emulsify the lens 112 and retract it into the tip 202. The tip 202 may be insulated to protect anatomical structures of the eye 100 that are not in contact with the member 246 from heat. In some variations, the tip 202 may include other heating elements, such as one or more of the temperature control elements 204 described herein. In some variations, the tip 202 may not include other heating elements. As shown in FIG. 14B, the member 246 may be disposed within a channel 254. When deployed, the distal end 250 of the member 246 may extend outside the tip 202 through the opening 203. The distal end 250 may apply heat to the lens 112 to soften and / or emulsify the lens 112. The softened and / or emulsified lens 112 may be sucked through the opening 203 and into the channel 254 of the tip 202. In some variations, the distal end 250 may oscillate (e.g., reciprocate), which may include oscillating in and out of the tip 202 and / or vibrating. As described herein, cryo may be applied by the distal end 250. As described herein, the temperature of the member 246 may be varied cyclically. As shown in FIG. 14C , the distal end 250 of the member 246 may be pointed (e.g., sharp, including a cutting edge, etc.).

[0260] The thermal system 200 may include a loop 218, as shown in FIG. 15A . A member 246 (e.g., a wire, a nitinol wire) may extend from inside the tip 202, form the loop 218, and extend back inside the tip 202. The loop 218 may be used to fragment (e.g., cut and scoop) the lens 112. The loop 218 may be rotated to fragment the lens 112. The loop 218 may be retracted (e.g., to reduce the diameter size) to fragment the lens 112 positioned inside the loop 218. In some variations, one side of the member 246 may be fixed, and the other side may be advanced and / or retracted to adjust the size of the loop 218. The loop 218 may be heated to soften and / or emulsify the lens 112, as described herein. In some variations, the loop 218 may be fully retracted and / or deployed from inside the tip 202. In some variations, the loop 218 may be used to capture, which may include extraction, the lens 112. The softened and / or emulsified lens 112 may be aspirated as described herein. In some variations, as shown in FIG. 15B , the portion of the member 246 that does not form the loop 218 may be positioned inside an insulating material 222 to protect the anatomical structures of the eye 100 other than the lens 112, which may include an insulating sheath, cover, etc.

[0261] 15C, the thermal system 200 may include multiple loops. The multiple loops may include at least a first loop 226, a second loop 228, and / or a third loop 230. The first loop 226 may be disposed inside the second loop 228. The second loop 228 may be disposed inside the third loop 230. The first loop 226 may have a smaller diameter than the diameter of the second loop 228. The second loop 228 may have a smaller diameter than the diameter of the third loop 230. A first member 232 (e.g., a wire, a nitinol wire) may form the first loop 226. A second member 234 (e.g., a wire, a nitinol wire) may form the second loop 228. A third member 236 (e.g., a wire, a nitinol wire) may form the third loop 230. First member 226 may extend from the inside of tip 202, form a first loop 226, and extend back to the inside of tip 202. Second member 234 may extend from the inside of tip 202, form a second loop 228, and extend back to the inside of tip 202. Third member 236 may extend from the inside of tip 202, form a third loop 230, and extend back to the inside of tip 202. In some variations, proximal portions of first member 232, second member 234, and / or third member 236 may be joined together. The diameter of first loop 226, second loop 228, and / or third loop 230 may be adjusted, and this adjustment may be achieved by retracting and / or deploying first loop 226, second loop 228, and / or third loop 230 from tip 202. The first loop 226, the second loop 228, and / or the third loop 230 may be temperature regulated (e.g., heated, cooled) as described herein. In some variations, one or more of the first loop 226, the second loop 228, and / or the third loop 230 may be temperature regulated, which may include independent temperature regulation.In some variations, portions of first member 232, second member 234, and / or third member 236 that do not form first loop 226, second loop 228, and / or third loop 230 may be positioned inside insulation 222, as described with reference to FIG. 15B.

[0262] FIG. 16 illustrates a mesh tool 238 that can be incorporated into the thermal system 200. The mesh tool 238 may extend from the tip 202, which may include being deployed from and retracted into the tip 202. The mesh 242 may be temperature regulated (e.g., heated, cooled). The mesh 242 may be connected to a member 246 (e.g., wire, nitinol wire) that can facilitate temperature regulation (e.g., heating, cooling) of the mesh 242. The mesh 242 may be made from a metal mesh such as stainless steel and / or nitinol. The mesh 242 may be heated to a temperature that softens and / or emulsifies the lens 112 to facilitate suction. The mesh 242 may fragment the lens 112. In some variations, the mesh 242 may be used to capture the lens 112 and remove it by extraction. The portion of the member 246 not connected to the mesh 242 may be positioned inside the insulation 222.

[0263] Systems and methods for utilizing heated fluids 17 illustrates an exemplary thermal emulsification system 300 (e.g., a thermal emulsification device, system, device, thermal liquefaction device, thermal liquefaction system, etc.), which may be handheld. The thermal emulsification system 300 may include a housing 316 that is ergonomically shaped to be held by a surgeon performing cataract surgery. The thermal emulsification system 300 may be used to liquefy (e.g., emulsify) the lens of the eye with a heated fluid. The thermal emulsification system 300 may include more or fewer features and / or components than those described herein. The thermal emulsification system 300 may include any of the features described elsewhere herein.

[0264] The thermal emulsification system 300 may include a fluid reservoir 312 (e.g., a chamber, compartment, container, bag, fluid source, tank). The fluid reservoir 312 may hold a fluid (e.g., saline or other fluid suitable for the eye). In some variations, the fluid reservoir 312 may be replaceable. In some variations, the fluid reservoir 312 may be for single use (e.g., disposable). For example, the fluid reservoir 312 may be removed after use, discarded as waste, and replaced with a new fluid reservoir 312 that may contain a new supply of fluid. In some variations, the fluid reservoir 312 may be reusable. For example, the fluid reservoir 312 may be refilled while integrated with the thermal emulsification system 300, which may include refilling a fluid reservoir 312 disposed within the housing 316 of the thermal emulsification system 300. The fluid reservoir 312 may optionally be removed from the housing 316 and then refilled. The fluid in the fluid reservoir 312 can be irrigated into the eye to liquefy (eg, emulsify) the lens 112 .

[0265] The thermal emulsification system 300 may include a waste reservoir 314 (e.g., a chamber, compartment, container, bag, tank). The waste reservoir 314 may hold waste material aspirated from the eye when removing the lens. For example, liquefied (e.g., emulsified) lens, lens fragments, aqueous humor of the eye, and / or fluids introduced into the eye by the thermal emulsification system 300 may be aspirated into the waste reservoir 314. The waste reservoir 314 may be replaceable. In some variations, the waste reservoir 314 may be for single use (e.g., disposable). For example, the waste reservoir 314 may be removed after use, discarded as waste, and replaced with a new waste reservoir 314, which may be empty. In some variations, the waste reservoir 314 may be reusable. For example, waste reservoir 314 may be drained and / or purged while integrated with thermal emulsification system 300, which may include draining and / or purging waste reservoir 314 disposed within housing 316 of thermal emulsification system 300. Waste reservoir 314 may be removed from housing 316, drained and / or purged, and reintegrated into thermal emulsification system 300.

[0266] The thermal emulsification system 300 can include a pump system 306 that can be used to irrigate and aspirate within the eye. The pump system 306 can include one or more pumps. The pump system 306 can pump fluid from a fluid reservoir 312 to the lens of the eye (e.g., inside the lens capsule), which can be referred to as irrigating the eye (e.g., the lens capsule). The pump system 306 can pump waste products, such as liquefied (e.g., emulsified) lens, lens fragments, aqueous humor of the eye, and / or fluid from the fluid reservoir 312 introduced into the eye, from the eye (e.g., the lens capsule) to a waste reservoir 314, which can be referred to as aspirating the eye.

[0267] The thermal emulsification system 300 can include a heating element and control system 308, which can also be described as a temperature adjustment system. The heating element and control system 308 can modify the temperature of the fluid delivered to the lens. In some variations, the heating element and control system 308 can increase and / or decrease the temperature of the fluid (e.g., heat and / or cool). In some variations, the heating element and control system 308 can only increase the temperature of the fluid (e.g., heat). In some variations, the heating element and control system 308 can adjust the temperature of the fluid downstream of the fluid reservoir 312. In some variations, the heating element and control system 308 can adjust the temperature of the fluid upon delivery into the eye. In some variations, the heating element and control system 308 can adjust the temperature of the fluid in the fluid reservoir 312. The heating element and control system 308 can adjust the temperature of the fluid using conduction, convection, and / or radiation.

[0268] The thermal emulsification system 300 may include a tip 130 (e.g., a cannula). The tip 130 may be disposed at a distal end of the thermal emulsification system 300, including at a distal end of the housing 316. The tip 130 may be disposed inside the eye and proximate to the lens 112. The tip 130 may be made of a variety of materials, including metals, metal alloys, polymers, ceramics, etc. The tip 130 may include an opening 150. Fluid may be delivered from the fluid reservoir 312 to the lens 112 through the opening 150. The thermal emulsification system 300 may include insulation 304 proximate the tip 130 to protect the anatomical structures surrounding the eye, including protecting the anatomical structures surrounding the eye from heat when the thermal emulsification system 300 is operating. The insulation 304 may be disposed circumferentially around the tip 130. In some variations, the fluid can be aspirated through an opening 150 in the tip 130 .

[0269] The thermal emulsification system 300 can include a temperature sensor 310 (e.g., a thermocouple). The temperature sensor 310 can sense (e.g., detect) the temperature of the fluid being delivered to the eye at the point of delivery (e.g., at the tip 130). The temperature sensor 310 can sense the temperature within the eye. The temperature sensor 310 and the heating element and control system 308 can be in communication. The heating element and control system 308 can adjust the temperature of the fluid being delivered to the lens based on the temperature sensed by the temperature sensor 310. For example, the temperature of the fluid may drop from a target temperature due to heat loss before delivery to the lens. The temperature sensor 310 can sense the dropping temperature of the fluid due to heat loss before delivery, and in response to receiving an indication of the dropping temperature of the fluid from the temperature sensor 310, the heating element and control system 308 can increase the temperature of the fluid to accommodate the heat loss.

[0270] The thermal emulsification system 300 can include a port 302 (e.g., an opening, an aperture). The port 302 can be used to aspirate waste material from the eye. In some variations, heated and / or unheated fluid can be delivered to the lens through the port 302. A pump system 306 can aspirate (e.g., vacuum, suck) waste material from within the eye (e.g., the lens capsule) through the port 302 and into a waste reservoir 314. The port 302 can be positioned in various locations. In some variations, the port 302 can be positioned within the insulation 304. In some variations, the port 302 can be positioned at the distal end of the tip 130. In some variations, the port 302 can be positioned on a side of the tip 130. The port 302 can be of various sizes and / or shapes, including circular, polygonal (e.g., triangular, square, rectangular, pentagonal, etc.), oval, irregular, or other.

[0271] Thermal emulsification system 300 can irrigate and aspirate simultaneously and / or at different times. For example, pump system 306 can irrigate (e.g., pump, force) heated fluid into the eye through opening 150 to liquefy and / or soften the lens. Pump system 306 can aspirate (e.g., pump, vacuum, force) fluid irrigated into the eye, the eye's aqueous humor, lens fragments, and / or liquefied lens material through port 302 and into waste reservoir 314.

[0272] In some variations, the thermal emulsification system 300 may be reusable. For example, various components of the thermal emulsification system 300 (e.g., the tip 130, the fluid reservoir 312, the waste reservoir 314, and / or others) may be cleaned for reuse, which may include disassembly and cleaning. In some variations, the various components of the thermal emulsification system 300 (e.g., the tip 130, the fluid reservoir 312, the waste reservoir 314, and / or others) may be intended for single use, such that the various components can be removed, discarded, and replaced with new components.

[0273] In some variations, the thermal emulsification system 300 may be intended for single use. For example, the thermal emulsification system 300 may be used to remove one or both lenses from a patient and then discarded. In some variations, the thermal emulsification system 300 may be used to remove only one lens, whereas two thermal emulsification systems 300 may be required to remove both lenses from a patient. In some variations, the thermal emulsification system 300 may be used to remove both lenses from a patient and then discarded, which may include replacing the fluid reservoir 312 and / or the waste reservoir 314 after removing the first lens.

[0274] The thermal emulsification system 300 may include a power source, such as one or more batteries. In some variations, the one or more batteries may be for single use. In some variations, the one or more batteries may be rechargeable.

[0275] The thermal emulsification system 300 may include a power interface. The power interface may be used to recharge a battery and / or to provide power to the thermal emulsification system 300. In some variations, the thermal emulsification system 300 may not include a battery and instead rely on wired power, which may be provided via the power interface. In some variations, one or more batteries may be recharged via wireless charging via the power interface.

[0276] The thermal emulsification system 300 may include one or more processors, controllers, valves (e.g., pinch valves, solenoid valves, proportional solenoid valves), diverters, sensors (e.g., flow sensors), filters, drivers, speakers, indicator lights, user interfaces (e.g., buttons, dials, knobs, touch screens, switches), displays, memory with software, microphones, regulators, clocks (e.g., real-time clocks), internal tubing, communication interfaces (e.g., wireless and / or wired), and / or other features. Valves may be used to open and close flow out of the fluid reservoir 312. Valves may be used to open and close flow into the waste reservoir 314. The speakers, indicator lights, and / or displays may issue safety alerts (e.g., when the temperature sensor 310 detects an unsafe temperature, when the flow sensor detects an unsafe flow, when the fluid in the fluid reservoir 312 falls below a threshold, when the waste in the waste reservoir 314 exceeds a threshold, etc.). A speaker, light (e.g., indicator light), and / or display can indicate the status of the thermoemulsification system 300 (e.g., on / off, fluid heated to the appropriate temperature, battery level, mode, etc.). A user interface can be used to control the thermoemulsification system 300 (e.g., start / stop irrigation, start / stop suction, adjust temperature, change mode, control lighting, etc.). A microphone can receive audio instructions. Light can be used to enhance intraocular visibility during surgery.

[0277] 18 illustrates an exemplary thermoemulsification system 400 (e.g., a thermoemulsification device, system, device, thermoliquefaction device, thermoliquefaction system, etc.). In some variations, the thermoemulsification system 400 can be incorporated into a phaco machine (e.g., retrofitted to a phaco machine to retrofit the phaco machine). The thermoemulsification system 400 can include any of the features described with reference to other systems herein. The thermoemulsification system 400 can include fewer or more features than those described herein.

[0278] Thermoemulsification system 400 can include a handheld tool 402 (e.g., handheld instrument, tool, instrument), which can be a phaco handpiece. Handheld tool 402 can include one or more, including all, of the features described with reference to thermoemulsification system 300 and / or other systems herein.

[0279] The thermal emulsification system 400 can include a fluid reservoir 416 (e.g., a fluid source, chamber, compartment, container, bag, tank). The handheld tool 402 can be fluidly coupled to the fluid reservoir 416. The fluid reservoir 416 can be positioned in an elevated position relative to the handheld tool 402. The fluid reservoir 416 can, in some variations, be an IV bag. The fluid reservoir 416 can hold a fluid (e.g., saline). The fluid reservoir 416 can be fluidly coupled to the handheld tool 402 by an irrigation tube 406 (e.g., a tube, line, conduit). The irrigation tube 406 can, in some variations, be insulated to reduce heat loss as the fluid travels from the fluid reservoir 416 to the handheld tool 402. The fluid in the fluid reservoir 416 can be delivered to the lens of the eye, liquefying and / or softening the lens and removing it. In some variations, the fluid reservoir 416 can be cleaned and reused. In some variations, the fluid reservoir 416 can be discarded after use and replaced with a new fluid-filled fluid reservoir 416. In some variations, various components of the thermal emulsification system 400 can be intended for single use (e.g., to remove both of a patient's lenses or to remove one of a patient's lenses).

[0280] The thermal emulsification system 400 can include a heating element and control system 414, which can also be described as a temperature adjustment system. The heating element and control system 414 can adjust the temperature of the fluid delivered to the lens. In some variations, the heating element and control system 414 can increase and / or decrease the temperature of the fluid (e.g., heat and / or cool). In some variations, the heating element and control system 414 can only increase the temperature of the fluid (e.g., heat). The heating element and control system 414 can be located along the irrigation tubing 406. The heating element and control system 414 can be located along the irrigation tubing 406 between the fluid reservoir 416 and the handheld tool 402. In some variations, the heating element and control system 414 can be located in the fluid reservoir 416 to adjust the temperature of the fluid in the fluid reservoir 416. In some variations, the heating element and control system 414 can include components (e.g., heating elements) in one or both of the fluid reservoirs 416 to adjust the temperature of the fluid within the fluid reservoirs 416 and along the irrigation tubing 406 and / or at the handheld tool 402 to further adjust the temperature of the fluid after it exits the fluid reservoirs 416. The heating element and control system 414 can adjust the temperature of the fluid using conduction, convection, and / or radiation.

[0281] The thermal emulsification system 400 may include one or more temperature sensors (e.g., thermocouples) at various locations. For example, the thermal emulsification system 400 may include a temperature sensor in the fluid reservoir 416 to measure the temperature of the fluid held in the fluid reservoir 416. The thermal emulsification system 400 may include one or more temperature sensors along the irrigation tubing 406. The thermal emulsification system 400 may include one or more temperature sensors in the heating element and control system 414. The thermal emulsification system 400 may include a temperature sensor 412 (e.g., a thermocouple) along the irrigation tubing 406 between the fluid reservoir 416 and the heating element and control system 414 (e.g., downstream of the fluid reservoir 416 and upstream of the heating element and control system 414). The temperature of the fluid measured by the temperature sensor 412 may be a factor in determining the amount of energy output by the heating element and control system 414 to adjust the temperature of the fluid to a desired temperature. The thermal emulsification system 400 can include temperature sensors 410 in the heating elements and control system 414. The thermal emulsification system 400 can include a temperature sensor 310 in the tip 130 (e.g., cannula). The temperatures sensed by the various temperature sensors in the thermal emulsification system 400 can be used to control the energy output by the heating elements and control system 414 to regulate the temperature of the fluid.

[0282] The thermal emulsification system 400 can include one or more valves. For example, the thermal emulsification system 400 can include a valve 418, which can be a pinch valve. The valve 418 can be operated to start and stop the flow of fluid from the fluid reservoir 416 to the handheld tool 402. The valve 418 or another component can regulate the flow rate of fluid from the fluid reservoir 416 to the handheld tool 402. In some variations, the handheld tool 402 can include a valve or other component to regulate the flow rate of fluid into the eye. The valve 418 can be manually operated or electronically operated. The valve 418 can automatically close upon a trigger event (e.g., when a sensed temperature rises above or falls below a threshold).

[0283] The thermal emulsification system 400 can include a waste reservoir 424 (e.g., a chamber, compartment, container, bag, tank). The waste reservoir 424 can be fluidly coupled to the handheld tool 402. The waste reservoir 424 can be fluidly coupled to the handheld tool 402 by a suction tube 404 (e.g., a tube, line, conduit). The suction tube 404 can, in some variations, be insulated. In some variations, the thermal emulsification system 400 can include a temperature sensor 408 along the suction tube 404 to sense the temperature of the waste flowing therethrough. The thermal emulsification system 400 can include a temperature sensor in the waste reservoir 424. The waste reservoir 424 can hold waste aspirated from the eye when the lens is removed. For example, liquefied (e.g., emulsified) lens, lens fragments, aqueous humor of the eye, and / or fluids introduced into the eye by the thermal emulsification system 400 can be aspirated into the waste reservoir 424. The waste reservoir 424 may be replaceable. The waste reservoir 424 may be for single use (e.g., disposable). For example, the waste reservoir 424 may be removed after use, discarded as waste, and replaced with a new waste reservoir 424, which may be empty. In some variations, the waste reservoir 414 may be reusable. For example, the waste reservoir 414 may be able to drain and / or purge waste while integrated with the thermal emulsification system 400. The waste reservoir 424 may be removed from the thermal emulsification system 400, drained and / or purged, and reintegrated with the thermal emulsification system 400.

[0284] The thermal emulsification system 400 can include a pump system 422, which can include one or more pumps. The pump system 422 can pump waste from the eye into a waste reservoir 424 (e.g., into the handheld tool 402, through the suction tube 404, and into the waste reservoir 424). The pump system 422 can be part of a phaco machine 420. In some variations, the suction tube 404, the temperature sensor 408, and / or the waste reservoir 424 can be components of the phaco machine 420 that cooperate with the thermal emulsification system 400. In some variations, the pump system 422 can pump fluid from the fluid reservoir 416 into the eye (e.g., through the irrigation tube 406 into the handheld tool 402 and into the eye). In some variations, the fluid in the fluid reservoir 416 can flow by gravity rather than through the pump system 422. For example, the fluid reservoir 416 may be located at an elevated position where gravity allows fluid to flow from the fluid reservoir 416, through the irrigation tubing 406, and into the handheld tool 402. As described herein, the thermal emulsification system 400 may include valves (e.g., valve 418) and / or other flow regulators to regulate the flow rate of the fluid. In some variations, one or more valves (e.g., one-way valves) may be located along the suction tubing 404, within the handheld tool 402, and / or in the waste reservoir 424 to prevent backflow of waste.

[0285] The thermal emulsification system 400 can be irrigated and aspirated simultaneously and / or at different times. In some variations, the thermal emulsification system 400 may be reusable. For example, the various components of the thermal emulsification system 400 (e.g., the tip 130, the fluid reservoir 416, the waste reservoir 424, and / or others) can be cleaned for reuse, which may include disassembly and cleaning. In some variations, the various components of the thermal emulsification system 400 (e.g., the tip 130, the fluid reservoir 416, the waste reservoir 424, and / or others) can be intended for single use, such that the various components can be removed, discarded, and replaced with new components.

[0286] In some variations, the thermal emulsification system 400 or its components may be intended for single use. For example, the thermal emulsification system 400 or its components may be used to remove one or both lenses from a patient and then discarded. In some variations, the thermal emulsification system 400 or its components may be used to remove only one lens; to remove both lenses from a patient, two thermal emulsification systems 400 may be required. In some variations, the thermal emulsification system 400 or its components may be used to remove both lenses from a patient and then discarded, which may include replacing the fluid reservoir 416 and / or the waste reservoir 424 after removing the first lens.

[0287] The thermal emulsification system 400, including its components, can include a power source, such as one or more batteries. In some variations, the one or more batteries may be for single use. In some variations, the one or more batteries may be rechargeable.

[0288] The thermal emulsification system 400 may include a power interface. The power interface may be used to recharge a battery and / or to power the thermal emulsification system 400. In some variations, the thermal emulsification system 400 may not include a battery and instead rely on wired power, which may be supplied via the power interface. In some variations, one or more batteries may be recharged via wireless charging via the power interface.

[0289] The thermal emulsification system 400 may include one or more processors, controllers, valves (e.g., pinch valves, solenoid valves, proportional solenoid valves), diverters, sensors (e.g., flow sensors), filters, drivers, speakers, indicator lights, user interfaces (e.g., buttons, dials, knobs, touchscreens, switches), displays, memory with software, microphones, regulators, clocks (e.g., real-time clocks), tubing, communication interfaces (e.g., wireless and / or wired), and / or other features. The speakers, indicator lights, and / or displays may emit safety warnings (e.g., a temperature sensor detects an unsafe temperature, a flow sensor detects an unsafe flow, fluid in the fluid reservoir 416 falls below a threshold, waste in the waste reservoir 424 exceeds a threshold, etc.). The speakers, lights (e.g., indicator lights), and / or displays may indicate the status of the thermal emulsification system 400 (e.g., on / off, fluid heated to the appropriate temperature, battery level, mode, etc.). A user interface can be used to control the thermoemulsification system 400 (e.g., start / stop irrigation, start / stop suction, adjust temperature, change modes, control lighting, etc.). A microphone can receive audio instructions. Light can be used to enhance intraocular visibility during surgery.

[0290] 19 illustrates an exemplary thermoemulsification system 500 (e.g., a thermoemulsification device, system, device, thermoliquefaction device, thermoliquefaction system, etc.). In some variations, the thermoemulsification system 500 can be incorporated into a phaco machine (e.g., retrofitted to a phaco machine to convert the phaco machine). The thermoemulsification system 500 can include any of the features described with reference to other systems herein. The thermoemulsification system 500, like other systems described herein, can include more or fewer features than those shown and described.

[0291] The thermal emulsification system 500 can include a device interface 580 (e.g., an interface) that can interface with a tool (e.g., a handheld tool 402, a phaco handpiece) that delivers heated fluid to the eye and / or aspirates waste products from the eye.

[0292] The thermal emulsification system 500 can include a delivery fluid system 556. The delivery fluid system 556 can include a heated tank 558 (e.g., a fluid source, fluid reservoir, chamber, compartment, container, bag, tank). The heated tank 558 can hold a fluid (e.g., saline). At the outlet of the heated tank 558 and / or downstream of the heated tank 558, the delivery fluid system 556 can include a filter 562, a pump 564, a flow meter 566, and / or a valve 568 (e.g., a proportional solenoid valve). The filter 562 can capture unwanted particles. The pump 564 can draw fluid from the heated tank 558 and push the fluid through a fluid delivery line 582 (e.g., a tube, a conduit) to a device interface 580. The flow meter 566 can detect the flow rate and / or other characteristics of the fluid. The valve 568 can be opened or closed to stop, allow, and / or regulate the flow of fluid therethrough. The detected fluid flow rate and / or other characteristics can be used to control pump 564 to adjust the fluid flow rate and / or adjust valve 568 to adjust the fluid flow rate through fluid delivery line 582 to device interface 580.

[0293] The thermal emulsification system 500 can include a thermal control system 534. The thermal control system 534 can regulate the temperature of the fluid delivered to the eye. For example, the thermal control system 534 can regulate the temperature of the fluid in the heated tank 558 (e.g., heat the fluid). The thermal control system 534 can include a heater 540 (e.g., a variable current driver). The heater 540 can include a heating element 544 that can heat the fluid in the heated tank 558, which can contain the fluid exiting the heated tank 558. The thermal control system 534 can include a temperature sensor interface 536 (e.g., a T-type thermocouple interface) and / or a safety sensor 538. The thermal control system 534 can include a temperature sensor 542 (e.g., a thermocouple) operably coupled to the temperature sensor interface 536. Temperature sensor 542 can sense the temperature of the fluid in heating tank 558, which can be used by thermal control system 534 to adjust the energy (e.g., current) output by heater 540 to regulate the temperature of the fluid in heating tank 558 to a desired target temperature. Temperature sensor (thermocouple) 542 can be located in heating tank 558, which can be contained within heating tank 558.

[0294] The thermal emulsification system 500 can include a return fluid system 570 (e.g., a waste system, a suction system). The return fluid system 570 can include a capture tank 572 (e.g., a chamber, compartment, container, bag, tank). The capture tank 572 can hold waste material aspirated from the eye when the lens is removed. For example, liquefied (e.g., emulsified) lens, lens fragments, aqueous humor from the eye, and / or fluids introduced into the eye by the thermal emulsification system 500 can be aspirated into the capture tank 572. The return fluid system 570 can include a pump 574, a flow meter 576, and / or a valve 578 (e.g., a proportional solenoid valve). The pump 574 can aspirate (e.g., apply a force, vacuum) waste material from the eye, to the handheld device, through the device interface 580, through a fluid return line 584 (e.g., a tube, a conduit), and into the capture tank 572. A flow meter 576 can be used to measure the flow rate and / or other characteristics of the waste material through the fluid return line 584. A valve 578 can be opened or closed to stop, allow, and / or regulate the flow of fluid therethrough to the capture tank 572. In some variations, the valve 578 is a one-way valve to prevent backflow. The detected fluid flow rate and / or other characteristics can be used to control the pump 574 to regulate the fluid flow rate and / or to regulate the valve 578 to regulate the fluid flow rate through the fluid return line 584 to the capture tank 572.

[0295] Thermal emulsification system 500 can include a fluid control system 546. Fluid control system 546 can control the flow of fluid through thermal emulsification system 500. Fluid control system 546 can include one or more pump drivers 548, flow safety modules 550, flow sensor interfaces 552, and / or valve actuation controllers 554. Pump driver 548 can operate pump 564 and / or pump 574. Flow sensor interface 552 can communicate with flow meters 566 and / or flow meters 576 to receive indications of sensed flow rates. Valve actuation controller 554 can be used to control valves 568 and / or valves 578. Pump driver 548 and / or valve actuation controller 554 can adjust the flow rate or even stop the flow when certain conditions are met. For example, if the flow rate is too high (e.g., above a threshold) in fluid delivery line 582 and / or fluid return line 584, pump driver 548 and / or valve actuation controller 554 can control pump 564, pump 574, valve 568, and / or valve 578 to decrease the flow rate to the target. If the flow rate is too low (e.g., below a threshold) in fluid delivery line 582 and / or fluid return line 584, pump driver 548 and / or valve actuation controller 554 can control pump 564, pump 574, valve 568, and / or valve 578 to increase the flow rate to the target.

[0296] The thermal emulsification system 500 may include a power system 502 to provide power to the thermal emulsification system 500. The power system 502 may include a battery 508, which may be rechargeable. The power system 502 may include a charging interface 510. The charging interface 510 may interface with a charger device 514 (e.g., a cable) to provide power from a power source 516 (e.g., a power outlet) to charge the battery 508 and / or directly power the thermal emulsification system 500. The power system 502 may include a power management module 512, a voltage regulator 506, and / or a gauge 504 (e.g., a power gauge, a power indicator, a battery power level indicator).

[0297] The thermal emulsification system 500 may include a control system 518. The control system 518 may include a microcontroller 520, a real-time clock 522 (e.g., RTC), and / or a memory 524. The real-time clock 522 may be used to identify trigger events to which the thermal emulsification system 500 responds. For example, the thermal emulsification system 500 may slow down the flow rate in the fluid delivery line 582 if the flow rate exceeds a threshold for a period of time (e.g., 1 second). The control system 518 may interface with a data analysis system 600. The data analysis system 600 may be used to record and analyze data related to the thermal emulsification system 500. The data analysis system 600 may include a port 606, by which the thermal emulsification system 500 may be connected. The data analysis system 600 may include an input 604, by which the data analysis system 600 may be connected to other computing systems. A data log 602 displays a graph of the fluid temperature in the heated tank 558 as a function of time.

[0298] The thermal emulsification system 500 may include a user interface system 526. The user interface system 526 may include one or more buttons 528 that may be used to adjust at least the temperature of the fluid, start / stop irrigation and / or aspiration, change modes, adjust flow rates, open / close valves, turn power on / off, and / or other adjustments. The user interface system 526, in some variations, may include dials, switches, displays, touchpads, touchscreens, knobs, triggers, indicators, gauges, sliders, and / or other features. The user interface system 526 may include an indicator 530 (e.g., an indicator light such as an LED). The indicator 530 may visually indicate when the thermal emulsification system 500 is ready for operation and / or when it is not ready for operation. The indicator 530 may visually indicate when the thermal emulsification system 500 is aspirating and / or irrigating. The indicator 530 may indicate the charge level of the battery 508. The indicator 530 can indicate when the thermal emulsification system 500 is communicating (e.g., transmitting data) with another computing system. The indicator 530 can provide alerts to the surgeon. The indicator 530 can emit light of various colors and / or patterns. The user interface system 526 can include a speaker 532 (e.g., a buzzer) that can emit audible sounds to communicate warnings, safety issue alerts, and / or sounds when various actions are performed (e.g., power on / off). In some variations, the user interface system 526 can include one or more displays, touchscreens, microphones for spoken commands, etc. In some variations, the indicator 530, speaker 532, display, touchscreen, etc. can indicate the fill level of the heating tank 558 and / or capture tank 572 and can include alerts when the fill level falls below or rises above a threshold.In some variations, the indicator 530, speaker 532, display, touch screen, etc., can communicate an indication of the length of time the thermoemulsification system 500 has been used, thereby indicating to the surgeon the amount of time remaining in which the eye can be safely irrigated with heated fluid.

[0299] The thermoemulsification system 500, in some variations, can include a wired and / or wireless communication interface for communicating with other computing devices. The thermoemulsification system 500, in some variations, can include a light for illuminating the eye during surgery.

[0300] 20A-20C illustrate a bimanual irrigation and aspiration method using heated fluid to liquefy the lens 112 for aspiration. As shown in FIG. 20A, after administering local anesthesia and preparing the eye 100 for surgery, dual small microincisions (e.g., less than 3 mm) can be made in the cornea 102 to provide access to the eye 100. These dual microincisions can be off-axis to reduce impact on vision and positioned similarly to the incisions used in manual microincision cataract surgery (MSICS). However, the dual small microincisions created may be smaller than the incisions currently made during MSICS. The anterior of the lens capsule 110 can be incised to access the lens 112. In some variations, two small microincisions can be made anteriorly (e.g., off-axis) to the lens capsule 110 to access the anterior portion of the lens capsule 110, thereby avoiding capsulorhexis. In some variations, a capsulorhexis may be performed to penetrate the capsular bag 110 and access the lens 112 therein.

[0301] An irrigation tip 700 (e.g., a cannula) can be introduced into the eye 100 and into the lens 112 through one microincision. An aspiration tip 704 (e.g., a cannula) can be introduced into the eye 100 and into the lens 112 through another microincision. The irrigation tip 700 and the aspiration tip 704 can generally be positioned opposite one another (e.g., approximately 180 degrees apart). Fluid heated to one of the temperature ranges described herein (e.g., 64-70°C, 66-70°C, 68-70°C) can be delivered to the lens 112 through an opening 702 (e.g., a distal opening, aperture) in the irrigation tip 700. The opening 702 can be located at the distal end of the irrigation tip 700. The heated fluid can liquefy the lens 112 as described herein. The heated fluid can penetrate the lens 112. The heated fluid can apply a low pressure to the lens 112 .

[0302] The liquefied lens 112 can be aspirated (e.g., vacuumed, sucked) through an opening 706 (e.g., a distal opening, aperture) in the aspirating tip 704. The opening 706 can be located at the distal end of the aspirating tip 704. The aspirating tip 704 can aspirate waste material (e.g., the liquefied lens 112, aqueous humor of the eye 100, lens fragments, and / or fluids introduced into the eye 100 by the irrigation tip 700). The aspirating tip 704 can be positioned proximate to the irrigation tip 700, which can include facing each other, to rapidly aspirate the heated fluid and / or liquefied lens 112 from the eye 100. The irrigation tip 700 and the aspirating tip 704 can be positioned such that the opening 702 in the irrigation tip 700 and the opening 706 in the aspirating tip 704 generally face each other. The suction tip 704 can rapidly aspirate the heated fluid and / or liquefied lens 112 to keep the heat localized.

[0303] As described herein, the fluid can be heated in a tank or the like upstream of the irrigation tip 700. For example, as shown in FIG. 20C , the heated fluid 708 can be transported through an internal lumen 716 and out an opening 702 of the irrigation tip 700 to the lens 112, liquefying the lens 112. The liquefied lens 112 and / or other waste material can be aspirated through the opening 706 into the internal lumen 718 of the aspirating tip 704. The aspirated material 710 can flow to a waste reservoir for disposal. In some variations, the fluid can be heated at the irrigation tip 700, which can include an opening 702.

[0304] In some variations, the irrigation tip 700 and the aspiration tip 704 can be a single tip that first irrigates the heated fluid and then aspirates the heated fluid and the liquefied lens 112 .

[0305] In some variations, irrigation and aspiration can be performed sequentially using the same incisions in the cornea 102 and / or lens capsule 110. For example, an irrigation tip 700 can be introduced to liquefy the lens 112 with a heated fluid. The irrigation tip 700 can then be retracted and an aspiration tip 704 can be introduced to aspirate the liquefied lens and heated fluid.

[0306] With the crystalline lens 112 removed, an intraocular lens can be introduced into the eye 100. For example, the intraocular lens can be placed within the capsular bag 110. The intraocular lens can be sized to fill the capsular bag, similar to a natural lens.

[0307] 21A-21C illustrate an irrigation and aspiration method using heated fluid to liquefy the lens 112. As shown in FIG. 21A, a single small microincision can be made in the cornea 102 to provide access to the eye 100. The anterior portion of the lens capsule 110 can be cut open to access the lens 112. In some variations, a microincision can be made anterior (e.g., off-axis) to the lens capsule 110 to access the interior of the capsule 110, thereby avoiding capsulorhexis. In some variations, capsulorhexis can also be performed to penetrate the capsule 110 and access the lens 112 therein.

[0308] The irrigation tip 700 and the aspiration tip 704 can be introduced into the eye 100 through a microincision in the cornea 102. The irrigation tip 700 and the aspiration tip 704 can be advanced to the lens 112 through an anterior cut in the lens capsule 110. The irrigation tip 700 and the aspiration tip 704 can be positioned juxtaposed. The irrigation tip 700 and the aspiration tip 704 can be positioned parallel to each other (e.g., the axes of the irrigation tip 700 and the aspiration tip 704 can be substantially parallel to each other). The irrigation tip 700 and the aspiration tip 704 can contact each other along their longitudinal sides. The opening 702 of the irrigation tip 700 can be positioned adjacent to the opening 706 of the aspiration tip 704. The axes of the opening 702 and the opening 706 can be substantially parallel.

[0309] In some variations, the irrigation tip 700 and the aspiration tip 704 can be introduced simultaneously. In some variations, the irrigation tip 700 and the aspiration tip 704 can be introduced in series. In some variations, the irrigation tip 700 and the aspiration tip 704 can be joined together, which can include joining the longitudinal sides together.

[0310] As shown in FIG. 21C , the heated fluid 708 can flow through an internal lumen 716, out of the opening 702 of the irrigation tip 700, and onto the lens 112. The lens 112 can be liquefied by the heated fluid 708. The heated fluid 708 and the liquefied lens 112 can be aspirated by the aspiration tip 704. The heated fluid 708 and the liquefied lens 112 can be aspirated through the opening 706 and into the internal lumen 718 of the aspiration tip 704. The aspirated material 710 can be directed to a waste reservoir. The heated fluid 708 can follow a generally curved flow path (e.g., a generally U-shape) between the opening 702 of the irrigation tip 700 and the opening 706 of the aspiration tip 704. The aspiration tip 704 can rapidly aspirate the heated fluid 708 and / or the liquefied lens 112 to localize the heat from the heated fluid 708. With the lens 112 removed, an intraocular lens can be introduced into the eye 100. For example, the intraocular lens can be placed within the capsular bag 110.

[0311] 22A-22H illustrate an irrigation and aspiration method using heated fluid to liquefy the lens 112. As shown in FIG. 22A, a single small microincision can be made in the cornea 102 to provide access to the eye 100. The anterior portion of the lens capsule 110 can be cut open to access the lens 112. In some variations, a microincision can be made anterior (e.g., off-axis) to the lens capsule 110 to access the interior of the capsule 110, thereby avoiding capsulorhexis. In some variations, capsulorhexis can also be performed to pierce the lens capsule 110 and access the lens 112 therein.

[0312] The coaxial system 701 (e.g., coaxial cannula, coaxial tip) can be advanced into the eye 100 through an incision in the cornea 102. The coaxial system 701 can be advanced to the lens 112 through an incision anterior to the capsular bag 110. The coaxial system 701 can include an outer tip 712 (e.g., outer cannula) and an inner tip 720 (e.g., inner cannula). As shown in FIG. 22C , the outer tip 712 and the inner tip 720 can be positioned coaxially. The inner tip 720 can be disposed inside the outer tip 712 (e.g., the inner tip 720 can be disposed inside the inner lumen 722 of the outer tip 712). In some variations, the outer tip 712 and the inner tip 720 may not be coaxial, but the inner tip 720 can still be disposed inside the outer tip 712.

[0313] 22C and 22D , the inner tip 720 can deliver the heated fluid 708 to the lens 112, and the outer tip 712 can aspirate the heated fluid 708 and / or liquefied lens 112. As shown in FIG. 22D , the heated fluid 708 can flow through an inner lumen 724 and out an opening 726 in the inner tip 720 to the lens 112. The opening 726 in the inner tip 720 can be proximal to the opening 714 in the outer tip 712. In some variations, the opening 726 in the inner tip 720 can be at the opening 714 in the outer tip 712. In some variations, the opening 726 in the inner tip 720 can be distal to the opening 714 in the outer tip 712.

[0314] The heated fluid 708 can flow through the opening 714 and into the lens 112, liquefying the lens 112. The outer tip 712 can aspirate (e.g., vacuum, suck) the heated fluid 708 and liquefied lens 112 through an internal lumen 722, which can include a space between the outer periphery of the inner tip 720 and an interior wall of the outer tip 712 that defines the internal lumen 722. The aspirated material 710 can flow to a waste reservoir. The heated fluid 708 and / or liquefied lens 112 can be aspirated through the opening 714 and into the internal lumen 722 of the outer tip 712. In some variations, the distal end of the outer tip 712, which defines the opening 714, can contact the lens 112.

[0315] 22E , in some variations, the outer tip 712 can deliver a heated fluid 708 to liquefy the lens 112, and the inner tip 720 can aspirate the heated fluid 708 and the liquefied lens 112. The heated fluid 708 can flow through an internal lumen 722 (e.g., the space between the outer periphery of the inner tip 720 and the inner wall of the outer tip 712 defines the internal lumen 722) and out of an opening 714 in the inner tip 720 to the lens 112. The inner tip 720 can aspirate the heated fluid 708 and / or the liquefied lens 112. For example, the heated fluid 708 and / or the lens 112 can be aspirated through an opening 726 into the internal lumen 724 of the inner tip 720.

[0316] As shown in FIG. 22F , in some variations, the coaxial system 701 can include a member 728 (e.g., a wire, a rigid member, a rod). The member 728 can be advanced through the coaxial system 701 and engage the lens 112, thereby aiding in breaking up the lens 112. The member 728 can be advanced through the inner tip 720 (e.g., the inner lumen 724 of the inner tip 720). In some variations, the member 728 can be heated, which may facilitate penetration of the lens 112 by the member 728. The inner tip 720 can deliver a heated fluid 708 to the lens 112, which can heat the member 728. In some variations, the member 728 can be heated by a source other than the heated fluid 708. In some variations, the member 728 can be advanced through the outer tip 712 (e.g., the inner lumen 722 of the outer tip 712). In some variations, member 728 can be used to cut an incision in the capsular bag 110 to introduce the coaxial system 701 .

[0317] As shown in FIGS. 22G and 22H , the coaxial system 701 can include an inner tip 720 having a closed distal end 730 (e.g., a distal deflection wall). The inner tip 720 can include one or more openings 732 (e.g., apertures) disposed in a sidewall of the inner tip 720. The one or more openings 732 can be distributed circumferentially around the axis of the inner tip 720 (e.g., around the sidewall). The heated fluid 708 can flow through the inner lumen 724 and out of the one or more openings 732 to the lens 112. The heated fluid 708 can enter the distal end 730, change direction at the distal end 730, and exit through the one or more openings 732. In some variations, the distal end 730 can contact the lens 112. In some variations, the distal tip 730 can be heated by the heated fluid 708 and / or by another source, thereby enabling the distal tip 730 to penetrate the lens 112 with thermal assistance.

[0318] 23A-23D illustrate irrigation and aspiration systems and methods that use heat to liquefy the lens 112. As shown in FIG. 23A, a single microincision can be made in the cornea 102 to provide access to the eye 100. The anterior portion of the lens capsule 110 can be cut open to access the lens 112. In some variations, a microincision can be made anterior (e.g., off-axis) to the lens capsule 110 to access the interior of the capsule 110, thereby avoiding capsulorhexis. In some variations, capsulorhexis can also be performed to penetrate the capsule 110 and access the lens 112 therein.

[0319] The suction tip 734 (e.g., a cannula) can be introduced into the eye 100 through a microincision in the cornea 102. The suction tip 734 can be advanced to the lens 112 through an anterior cut in the lens capsule 110. The suction tip 734 can include a heated element 736 (e.g., a heating portion). The heated element 736 can be disposed at a distal end of the suction tip 734. For example, as shown in FIG. 23C , the heated element 736 can define an opening 715 into the suction tip 734, which can include defining a wall surrounding an internal lumen 738 of the suction tip 734. The heated element 736 can be disposed circumferentially around the axis of the internal lumen 738. The heated element 736 can be disposed circumferentially around the axis of the internal lumen 738. The heated element 736 can be heated to a temperature range described herein (e.g., 64-70°C, 66-70°C, and 68-70°C). The heated element 736 can contact the lens 112 to liquefy the lens 112. The liquefied lens 112 can be aspirated by the aspiration tip 734 (e.g., through opening 715 and into the interior lumen 738 of the aspiration tip 734). The aspirated material 710 can flow to a waste reservoir.

[0320] As shown in FIG. 23D , in some variations, a member 744 (e.g., a wire, rigid member, rod) can be advanced through the suction tip 734 (e.g., through the internal lumen 738 of the suction tip 734). The member 744 can include a heated element 746 (e.g., a heating portion). The heated element 746 can be disposed on the distal end of the member 744. The heated element 746 can be heated to at least a temperature range described herein (e.g., 64-70°C, 66-70°C, and 68-70°C). The member 744 can be advanced through the suction tip 734 to the lens 112. The heated element 746 can contact the lens 112 and liquefy it. The liquefied lens 112 can be aspirated through the suction tip 734 (e.g., through the opening 715 and into the internal lumen 738 of the suction tip 734). The aspirated material 710 can flow to a waste reservoir. In some variations, member 744 can be automatically deployed to a more distal position and / or automatically retracted to a more proximal position, which can be achieved by a biasing mechanism such as a spring. The portion of member 744 proximal to heated element 746 can be insulated.

[0321] 24-29B illustrate various irrigation tips that can be used to liquefy the lens 112 with a heated fluid. The irrigation tips can be deployed within a nested cannula system and / or inserted independently into the eye. The irrigation tips can be insulated. The irrigation tips can include flow cross-sections of various shapes (e.g., circular, elliptical, polygonal, etc.) and / or sizes.

[0322] FIG. 24 shows an irrigation tip 748 (e.g., a cannula). The irrigation tip 748 can include a closed distal end 752, which can be rounded and / or angled. The closed distal end 752 can include an inner wall (e.g., a deflected wall), which can be rounded and / or angled. The irrigation tip 748 can include one or more openings 754 (e.g., apertures). The one or more openings 754 can be disposed in a sidewall of the irrigation tip 748 that defines the internal lumen 750. The one or more openings 754 can be disposed circumferentially around the axis of the irrigation tip 748 (e.g., the axis of the internal lumen 750). The one or more openings 754 can be disposed proximate the distal end 752. The one or more openings 754 can be circumferentially disposed about the axis of the irrigation tip 748 (e.g., the axis of the inner lumen 750). The heated fluid can flow distally through the inner lumen 750 to the distal end 752, be deflected by the distal end 752, and exit through the one or more openings 754 to the lens 112. The one or more openings 754 can be of various sizes and / or shapes.

[0323] 25A-25C illustrate an irrigation tip 756 (e.g., a cannula). The irrigation tip 756 can be an open guide tube. The irrigation tip 756 can include a closed distal end 760, which can include a flat outer surface (e.g., a flat surface perpendicular to the axis of the irrigation tip 756) as seen in FIG. 25C and / or a curved inner surface as seen in FIG. 25C. The irrigation tip 756 can include one or more openings 762 (e.g., apertures), such as one, two, three, four, five, six, or more. The one or more openings 762 can be disposed in a sidewall of the irrigation tip 756 that defines the internal lumen 758. The one or more openings 762 can be disposed circumferentially around the axis of the irrigation tip 756 (e.g., the axis of the internal lumen 758). The one or more openings 762 can be disposed proximate the distal end 760. The heated fluid can flow distally through the internal lumen 758 and out one or more openings 762 to the lens 112. The heated fluid can flow distally through the internal lumen 758 to the closed distal end 760, be deflected by the closed distal end 760, and out one or more openings 762 to the lens 112. The one or more openings 762 can be of various sizes and / or shapes. The one or more openings 762 can be longitudinal.

[0324] 26A and 26B illustrate an irrigation tip 766 (e.g., a cannula). The irrigation tip 766 can direct the flow of heated fluid proximally. The irrigation tip 766 can include a curved distal portion 770. The curved distal portion 770 can redirect the flow of heated fluid from a distal direction to a proximal direction. The heated fluid flows distally through an internal lumen 768 of the irrigation tip 766 to the curved distal portion 770, which redirects the flow proximally and can exit through an opening 772 facing proximally toward the lens 112. As shown in FIG. 26B, the opening 772 can face an aspiration tip 774 (e.g., a cannula) that can aspirate the heated fluid and / or the liquefied lens 112. The opening 772 can face an opening 776 in the aspiration tip 774. Opening 772 and opening 776 can be generally aligned (eg, coaxially aligned).

[0325] 27 shows an irrigation tip 778 (e.g., a cannula). The irrigation tip 778 can include a flared portion 784 (e.g., a cone). The flared portion 784 can enlarge (e.g., gradually widen) the internal lumen 780 of the irrigation tip 778 in a distal direction until it reaches an opening 782. The flared portion 784 can diffuse the heated fluid out of the opening 782. The flared portion 784 can be positioned distally.

[0326] 28 shows an irrigation tip 786 (e.g., a cannula). The irrigation tip 786 can include a distal end 788, which can be a cutting distal end. The distal end 788 can be used to cut the lens 112. The irrigation tip 786 can include one or more openings 790 (e.g., apertures, jets). Heated fluid can flow distally through the irrigation tip 786 and exit the one or more openings 790. In some variations, the heated fluid can heat the distal end 788 and facilitate cutting of the lens 112.

[0327] 29A and 29B illustrate an irrigation tip 824 (e.g., a cannula). As shown in FIG. 29A, the irrigation tip 824 can include a closed distal end 826, which can include a flat outer surface (e.g., including a flat surface perpendicular to the axis of the irrigation tip 824) and / or a curved inner surface 828. The irrigation tip 824 can include one or more openings 830 (e.g., apertures), such as one, two, three, four, five, six, or more. The one or more openings 830 can be disposed in a sidewall of the irrigation tip 824 that defines an internal lumen 836. The one or more openings 830 can be disposed circumferentially around the axis of the irrigation tip 824 (e.g., the axis of the internal lumen 836). The one or more openings 830 can be disposed proximate the distal end 826. The heated fluid can flow distally through the internal lumen 836 and out one or more openings 830 to the lens 112. The heated fluid can flow distally through the internal lumen 836 to the closed distal end 826, be deflected by the curved internal surface 828, and out one or more openings 830 to the lens 112. The one or more openings 830 can be of various sizes and / or shapes. The one or more openings 830 can be longitudinal. The irrigation tip 824 can be deployed inside the aspiration tip 832. For example, the irrigation tip 824 can be advanced distally through the openings 834 of the aspiration tip 832. The irrigation tip 824 can liquefy the lens 112 with the heated fluid flowing through the one or more openings 830. The aspiration tip 832 can aspirate and remove the heated fluid, the liquefied lens, and / or other substances through the openings 834 of the aspiration tip 832.

[0328] 30-33 illustrate various aspiration tips that can be used to aspirate waste materials from the eye, which can include heated fluids, liquefied crystalline lens, aqueous materials, and / or other materials introduced into the eye. The aspiration tips can be deployed within a nested cannula system and / or inserted independently into the eye. The aspiration tips can be insulated. The aspiration tips can include flow cross sections of various shapes (e.g., circular, oval, polygonal, etc.) and / or sizes.

[0329] 30 shows an aspiration tip (e.g., a cannula) 800. The aspiration tip 800 can include a distal opening 802 through which material can be aspirated into an internal lumen 804 and removed.

[0330] 31 shows an aspiration tip 806 (e.g., a cannula). The aspiration tip 806 can include a distal end 808. The distal end 808 can include an opening. The distal end 808 can include a cutting edge (e.g., a blade). The cutting edge can be disposed around the opening in the distal end 808. Material can be aspirated through the opening in the distal end 808 into an internal lumen 810.

[0331] 32 shows an aspiration tip 812 (e.g., a cannula). The aspiration tip 812 can include a flared portion 816 (e.g., a cone). The flared portion 816 can expand (e.g., gradually widen) the internal lumen 810 of the aspiration tip 812 distally until it reaches an opening 814, which can provide an enlarged opening 814 for capturing material. The flared portion 816 can be positioned distally. Material can be aspirated into the internal lumen 810 through the opening 814.

[0332] 33 shows an aspiration tip 818 (e.g., a cannula). The aspiration tip 818 can include a distal end 820, which can be rounded. The aspiration tip 818 can include one or more openings 822 (e.g., apertures), and can include one, two, three, four, or more. The one or more openings 822 can be disposed in a sidewall of the aspiration tip 818 that defines the internal lumen 810. Material can be aspirated into the internal lumen 810 and removed through the one or more openings 822.

[0333] Various additional features of the systems and methods described herein are detailed below. In some variations, the heated fluid and / or heated elements described herein can be used to cut incisions through the cornea and / or lens capsule to access the lens of the eye. Fluid heating can be performed externally and attached as a module to current irrigation / aspiration equipment (e.g., a phaco machine). Fluid heating can also be performed within the syringe barrel, as handheld units can also include irrigation / aspiration equipment. Fluid heating can be performed at any location in the systems and methods described herein, as long as the temperature of the fluid at the lens is within the specified ranges described herein. As described herein, temperature sensors (e.g., thermocouples) can be placed throughout the system and / or within the eye to ensure a closed-loop system controls temperature modulation. Various heating sources can be used to heat the heating element and / or fluid, including at least (electrical, radio frequency, ultrasound, laser, microwave, heat gun, immersion heater, chemical reaction, gas, nuclear, and / or other). In some variations, the distal tip and / or body of the irrigation and / or aspiration cannula described herein can be insulated. The heated fluid can be introduced into the lens by various techniques, which can include at least starting at the cortex / nucleus of the lens and dissipating / emulsifying from the inside out, using injection as a method to break the lens into fragments / fragments, or starting from the periphery and penetrating the lens and aspirating / extracting. In some variations, an irrigation cannula can be inserted into the core of the lens, and then the heated fluid can be irrigated and emulsified from the center outward. The systems and methods allow the surgeon to use microincisions in the lens capsule, thereby preserving the eye's capsule and / or zonucleus. Localized heating (eg, heated fluid) by convection allows emulsification of the lens 112 (eg, cataract proteins) without disturbing nearby tissue.The methods for removing the lens described herein using heated elements and / or heated fluids can be performed in seconds to less than a minute while preserving the lens capsule and zonules. In some variations, the systems described herein can include a separate handpiece or a handpiece controlled by a phaco handpiece / heater facility. The irrigation described herein is performed at low pressure, thereby reducing excessive heat transfer to the tissue. The systems and methods described herein can be used in robotic surgery.

[0334] 33A and 33B show an irrigation handpiece 1000, which may also be referred to as an irrigation device and / or irrigation tool. The irrigation handpiece 1000 may be held by a clinician's hand 1020 and / or operated by or incorporated into a robot to deliver heated fluid to the lens 112 of the eye 100.

[0335] The irrigation handpiece 1000 can include a port 1010 (e.g., an inlet) through which a fluid (e.g., saline) can be delivered to the irrigation handpiece 1000. In some variations, a heated fluid can be delivered to the irrigation handpiece 1000. In some variations, a fluid can be delivered to the irrigation handpiece 1000, and the irrigation handpiece 1000 can heat the fluid before delivering it into the eye. The port 1010 can be located on a proximal portion of the irrigation handpiece 1000. The port 1010 can be fluidly coupled to a reservoir (e.g., a container, bag, IV bag, vessel, etc.) of fluid (e.g., saline).

[0336] The irrigation handpiece 1000 can include an irrigation tube 1002 (e.g., a tube, a cannula, a needle). The irrigation tube 1002 can be inserted through the cornea 102 and into the capsular bag 110 to direct heated fluid to the lens 112. The irrigation tube 1002 can be elongated. The irrigation tube 1002 can include a curved portion. For example, the irrigation tube 1002 can include a straight proximal portion and then curve into a distal portion that is angled relative to the proximal portion. The irrigation tube 1002 can include a distal portion that is angled relative to the proximal portion. The irrigation tube 1002 can be of various sizes (e.g., diameters), including at least 0.1 to 3.0 millimeters, 1.0 to 2.5 millimeters, or less than 2.0 millimeters. The irrigation tube 1002 can be disposed in a distal portion of the irrigation handpiece 1000.

[0337] The irrigation tubing 1002 can include one or more outlets 1006 (e.g., openings, holes), and can include at least one, two, three, four, or more outlets 1006. The one or more outlets 1006 can be located in a distal portion of the irrigation tubing 1002. The one or more outlets 1006 can be located through a peripheral wall of the irrigation tubing 1002. For example, in some variations, the distal end of the irrigation tubing 1002 can be closed, and two outlets 1006 can be located in a peripheral wall of the irrigation tubing 1002, including the two outlets 1006 being positioned approximately 180 degrees apart from each other. Fluid received through a port 1010 of the irrigation handpiece 1000 can exit the irrigation tubing 1002 via one or more outlets 1006.

[0338] The irrigation handpiece 1000 can include a distal portion 1004 (e.g., end portion, distal piece, connector, tip, distal tip). The irrigation tubing 1002 can be coupled to the distal portion 1004. The distal portion 1004 can include a conical shape. The distal portion 1004 can be coupled to a body 1008 (e.g., a housing) of the irrigation handpiece 1000, which can include being removably coupled to the body 1008. In some variations, the distal portion 1004 can be a disposable component (e.g., a disposable end piece) that is replaced during surgery. In some variations, the irrigation handpiece 1000 is disposable and can be replaced during surgery. The body 1008 can be ergonomically designed to be held by the hand 1020. The main body 1008 can house one or more features of the irrigation handpiece 1000, which can include at least one or more heaters (e.g., heating devices), fluid lines (e.g., tubes, lumens, hoses, etc.) that direct the flow of fluid received through the port 1010, valves, conduits (e.g., wires), a processor, a controller, a power interface, a battery, memory, a wireless communication data interface, a wired communication data interface, a user interface (e.g., a display, a speaker, a microphone, buttons, toggles, switches, dials, sliders, etc.), indicators (e.g., lights, speakers, etc.), etc.

[0339] The irrigation handpiece 1000 can include an interface 1014 (e.g., port, connector) for coupling with a cable 1012. The cable 1012 can provide power to the irrigation handpiece 1000. Power can be provided to the irrigation handpiece 1000 from a console (e.g., power source, computing device) via the cable 1012. The cable 1012 can communicate data, including temperature data, flow rate data, instructions, etc., between the irrigation handpiece 1000 and the console. In some variations, data can be communicated wirelessly between the irrigation handpiece 1000 and the console.

[0340] The irrigation handpiece 1000 may include a user interface 1016 (e.g., a toggle, switch, button, dial, slider, etc.). The user interface 1016 may be used to control the flow of heated fluid out of the irrigation tube 1002. In some variations, the user interface 1016 may be manipulated to stop or start the flow of heated fluid out of the irrigation tube 1002. In some variations, by default, fluid may flow out of the irrigation tube 1002 to maintain pressure within the lens capsule 110 during cataract surgery, but upon interacting with the user interface 1016 (e.g., interacting with, pushing, pulling, and / or toggling the user interface 1016), heated fluid may flow out of the irrigation tube 1002 and emulsify the lens 112. In some variations, the user interface 1016 may be manipulated to adjust the temperature of the heated fluid.

[0341] The irrigation handpiece 1000 may include one or more indicators 1018 (e.g., a light, a speaker, a display, etc.). The one or more indicators 1018 may indicate a status of the irrigation handpiece 1000. For example, the one or more indicators 1018 may indicate when the irrigation handpiece 1000 is receiving power. The one or more indicators 1018 may indicate when heated fluid for emulsifying the lens 112 is and / or is not flowing out of the irrigation tubing 1002. In some variations, the one or more indicators 1018 may indicate when the temperature of the irrigation tubing 1002 is above or below a threshold value.

[0342] Irrigation handpiece 1000 can include any other irrigation device, suction device, thermal device, and / or any feature of other devices or systems described herein. In some variations, irrigation handpiece 1000 can also provide suction.

[0343] 34A and 34B show irrigation handpiece 1022, which may include features of irrigation handpiece 1000. Irrigation handpiece 1022 may be powered by a battery (e.g., a disposable battery, a rechargeable battery) rather than an external power source like irrigation handpiece 1000. Thus, irrigation handpiece 1022 may not have interface 1014 for connecting cable 1012.

[0344] The irrigation handpiece 1022 can include a user interface 1017 (e.g., a toggle, a switch, a button, a dial, a slider, etc.) that can be used to turn the irrigation handpiece 1022 on and off (e.g., to activate the irrigation handpiece 1022).

[0345] 35A and 35B show an aspiration handpiece 1024, which may also be referred to as an aspiration device and / or aspiration tool, that can be held by a clinician's hand 1020 and / or operated by or incorporated into a robot to aspirate substances such as fluid, heated fluid, and / or emulsified lens 112 from the lens capsule 110.

[0346] The aspiration handpiece 1024 can include a port 1034 (e.g., an outlet) through which the fluid, heated fluid, and / or emulsified lens 112 can leave (e.g., be aspirated from) the irrigation handpiece 1000. The port 1034 can be located at a proximal portion of the aspiration handpiece 1024. A vacuum can aspirate material from the aspiration handpiece 1024 through the port 1034. The port 1034 can be fluidly coupled to a container, such as a vacuum canister (e.g., a separator). The port 1034 can be fluidly coupled to a wall vacuum.

[0347] The aspiration handpiece 1024 may include an aspiration tube 1026 (e.g., a tube, a cannula, a needle). The aspiration tube 1026 may be inserted through the cornea 102 and into the capsular bag 110 to aspirate substances such as fluid, heated fluid, and / or emulsified lens 112. The aspiration tube 1026 may be elongated. The aspiration tube 1026 may include a curved portion. For example, the aspiration tube 1026 may include a straight proximal portion that then curves into a distal portion that is angled relative to the proximal portion. The aspiration tube 1026 may include a distal portion that is angled relative to the proximal portion. The aspiration tube 1026 may have a variety of sizes (e.g., diameters), including at least 0.1 to 3.0 millimeters, 1.0 to 2.5 millimeters, or less than 2.0 millimeters. The aspiration tube 1026 may be disposed at a distal portion of the aspiration handpiece 1024.

[0348] The suction tube 1026 can include one or more inlets 1028 (e.g., openings, holes), and can include at least one, two, three, four, or more inlets 1028. The one or more inlets 1028 can be located at a distal portion of the suction tube 1026. The one or more inlets 1028 can be located through a peripheral wall of the suction tube 1026. For example, in some variations, the distal end of the suction tube 1026 can be closed, and two inlets 1028 can be located on a peripheral wall of the suction tube 1026, including the two inlets 1028 being positioned approximately 180 degrees apart from each other. Material aspirated through the one or more inlets 1028 can exit (e.g., be aspirated from) the aspiration handpiece 1024 via a port 1034.

[0349] The aspiration handpiece 1024 can include a distal portion 1030 (e.g., end portion, distal piece, connector, tip, distal tip). The aspiration tube 1026 can be coupled to the distal portion 1030. The distal portion 1030 can include a conical shape. The distal portion 1030 can be coupled to a body 1032 (e.g., a housing) of the aspiration handpiece 1024, which can include being removably coupled to the body 1032. In some variations, the distal portion 1030 can be a disposable component (e.g., a disposable end piece) that is replaced during surgery. In some variations, the body 1032 can be ergonomically designed to be held by the hand 1020. The body 1032 can house one or more features of the aspiration handpiece 1024, which can include at least one or more valves, fluid lines (e.g., tubes, lumens, hoses, etc.), conduits (e.g., wires), processors, controllers, power interfaces, batteries, memory, wireless communication data interfaces, wired communication data interfaces, user interfaces (e.g., displays, speakers, microphones, buttons, toggles, switches, dials, sliders, etc.), indicators (e.g., lights, speakers, etc.), etc.

[0350] The aspiration handpiece 1024 can include a user interface 1036 (e.g., a toggle, switch, button, dial, slider, etc.). The user interface 1036 can be used to control suction by the aspiration handpiece 1024. In some variations, the user interface 1036 can be manipulated to stop or start suction. In some variations, the user interface 1036 can be manipulated (e.g., interacting with, pushing, pulling, and / or toggling) to adjust suction (e.g., increase or decrease flow rate, pressure, etc.).

[0351] In some variations, the aspiration handpiece 1024 can include one or more indicators (e.g., a light, a speaker, a display, etc.). The one or more indicators can indicate a state of the aspiration handpiece 1024, which can include an occlusion state. For example, the one or more indicators can indicate when the aspiration handpiece 1024 is in a configuration for aspiration (e.g., a valve is open). The one or more indicators can indicate when the temperature of the aspiration tube 1026 is above or below a temperature threshold.

[0352] 36A and 36B show a distal portion 1004 of the irrigation hand piece, which can be the same as the distal portion 1030 of the aspiration hand piece. As described herein, the distal portion 1004 can be coupled (e.g., removably coupled) to the irrigation hand piece. The distal portion 1004 can include a proximal portion 1005, which can be disposed within the irrigation hand piece to facilitate coupling. In some variations, the proximal portion 1005 can be coupled to the irrigation hand piece using various techniques, which can include at least a threaded connection, a press fit, a fastener connection (e.g., a bolt, pin, latch, etc.), a spring, and / or other techniques. The irrigation tubing 1002 coupled to the distal portion 1004 can include one or more outlets 1006 (e.g., two outlets 1006). The outlets 1006 can be disposed through a peripheral wall of the irrigation tubing 1002, as shown. The outlets 1006 can be located on either side (e.g., 180 degrees apart) of the irrigation tube 1002. The suction tube 1026 and one or more inlets 1028 can be similarly located. As described herein, the distal portion 1004 and / or distal portion 1030 can be disposable (e.g., replaced between procedures).

[0353] 37 shows a schematic diagram of irrigation system 1038. Irrigation system 1038 can include irrigation handpiece 1040, which can be and / or include any of the features of at least irrigation handpiece 1000 and irrigation handpiece 1022.

[0354] As shown, a reservoir 1044 (e.g., a container, bag, IV bag, vessel, etc.) can supply fluid (e.g., saline) to the irrigation handpiece 1040. An inlet line 1042 (e.g., inlet tubing, conduit, hose) can direct the flow of fluid from the reservoir 1044 to the irrigation handpiece 1040. In some variations, one or more valves can be disposed at the outlet of the reservoir 1044 and / or along the inlet line 1042 to selectively stop the flow of fluid to the irrigation handpiece 1040. In some variations, one or more flow regulators can be adjustable (e.g., automatically adjustable) and can be disposed at the outlet of the reservoir 1044 and / or along the inlet line 1042 to regulate the flow of fluid to the irrigation handpiece 1040.

[0355] The inlet line 1042 can split into a first fluid line 1046 (e.g., tubing, conduit, hose) and a second fluid line 1048 (e.g., tubing, conduit, hose). The split can be external or internal to the body of the irrigation handpiece 1040. The first fluid line 1046 can conduct fluid from the reservoir 1044 to a valve 1052. The second fluid line 1048 can conduct fluid from the reservoir 1044 to a heater 1050 (e.g., a heating device, cartridge heater, electrode, heated element) and then to the valve 1052. The heater 1050 can heat the fluid to at least the temperatures described herein (e.g., between 64 and 70°C). The heater 1050 can heat the fluid to a precise temperature regardless of the inlet temperature. In some variations, the heater 1050 can heat the fluid to a temperature above that described herein to accommodate heat loss before delivery to the lens 112, so that the heated fluid is at a temperature described herein (e.g., a value between 64 and 70°C) when delivered to the lens 112.

[0356] In some variations, the valve 1052 can alternate between allowing flow through the first fluid line 1046 while stopping flow through the second fluid line 1048, and allowing flow through the second fluid line 1048 while stopping flow through the first fluid line 1046. For example, the irrigation handpiece 1040 can include a user interface 1060 (e.g., a toggle, switch, button, dial, slider, etc.) that can be interacted with (e.g., pushed, pulled, depressed, rotated, etc.) to reconfigure the valve 1052 to allow or stop flow through the first fluid line 1046 and the second fluid line 1048. For example, a surgeon performing cataract surgery using irrigation handpiece 1040 can interact with user interface 1060 to configure valve 1052 to stop flow through first fluid line 1046, allow flow through second fluid line 1048, and direct heated fluid through outlet line 1062 to irrigation tubing for delivery to lens 112. In some variations, valve 1052 can be manipulated (e.g., actuated) to stop fluid flow through first fluid line 1046, allow fluid flow through first fluid line 1046, stop fluid flow through second fluid line 1048, and / or allow fluid flow through second fluid line 1048.

[0357] When the valve 1052 is configured to allow flow through the first fluid line 1046 while stopping flow through the second fluid line 1048, fluid from the reservoir 1044 can flow through the first fluid line 1046 to the outlet line 1062 (e.g., tubing, conduit, hose) of the irrigation handpiece 1040 without being sent to the heater 1050 (e.g., without being heated) and delivered into the lens capsule 110 by the irrigation tube of the irrigation handpiece 1040, thereby enabling the irrigation system 1038 to perform irrigation without heated fluid. When the valve 1052 is configured to stop flow through the first fluid line 1046 while allowing flow through the second fluid line 1048, fluid from the reservoir 1044 can flow through the second fluid line 1048 to the heater 1050 for heating and to the outlet line 1062 and delivered to the lens 112 in the capsular bag 110 by the irrigation tubing of the irrigation handpiece 1040, thereby enabling the irrigation system 1038 to emulsify and aspirate the lens 112. The heater 1050 can adjust (e.g., increase, decrease) the energy delivered to the fluid in the second fluid line 1048 to change the temperature of the fluid. The heater 1050 can adjust the energy delivered to the fluid in the second fluid line 1048 based on a temperature sensed in the irrigation tubing and / or elsewhere in the irrigation handpiece 1040. For example, if the temperature sensed in the irrigation tubing is above a threshold, the heater 1050 can reduce the energy delivered to the fluid. If the temperature sensed at the irrigation tubing falls below a threshold, the heater 1050 can increase the energy delivered to the fluid.

[0358] 38 illustrates an irrigation system 1039 that can include features of the irrigation system 1038. The irrigation system 1039 can include a spring valve 1066 that can control the flow of fluid through the first fluid line 1046 and the second fluid line 1048. The spring valve 1066 can include a first fluid opening 1054 (e.g., a flow path) and a second fluid opening 1056 (e.g., a flow path). The spring valve 1066 can include a spring 1058 (e.g., a resilient member). The spring 1058 can bias the spring valve 1066 (e.g., in its default configuration) such that the first fluid opening 1054 is positioned (e.g., positioned in the first fluid line 1046), allowing fluid flowing through the first fluid line 1046 to pass through the spring valve 1066 to the outlet line 1062 and be delivered to the eye 100 through the irrigation tubing of the irrigation handpiece 1040. By interacting (e.g., pushing) the user interface 1060 to overcome the biasing force of the spring 1058 and position the second fluid opening 1056 (e.g., positioning the second fluid opening 1056 in the second fluid line 1048), fluid flowing through the second fluid line 1048 can pass through the spring valve 1066 to the outlet line 1062, allowing heated fluid to be delivered to the lens 112 through the irrigation tubing of the irrigation handpiece 1040.

[0359] 38 shows a schematic diagram of the aspiration system 1069. The aspiration system 1068 can include an aspiration handpiece 1094, which can be at least the aspiration handpiece 1024 and / or include any of the features thereof.

[0360] As shown, the aspiration system 1069 can include a vacuum line 1074 (e.g., tubing, conduit, hose) fluidly coupled to an aspiration handpiece 1094. The vacuum line 1074 can provide vacuum suction (e.g., suction, suction force) to the aspiration handpiece 1094. As described herein, the aspiration handpiece 1094 can include an aspiration tube that can be introduced into the lens capsule 110 to aspirate the fluid, heated fluid, and / or emulsified lens 112. The aspiration handpiece 1094 can include an inlet line 1070 (e.g., tubing, conduit, hose) through which aspirated material can flow into the aspiration handpiece 1094.

[0361] The aspiration handpiece 1094 can include a valve 1104 (e.g., a spring valve) that can stop or allow vacuum aspiration (e.g., suction, suction) from the vacuum line 1074 that aspirates material through an aspiration tube disposed within the lens capsule 110. The valve 1104 can include an obstruction 1096 (e.g., a barrier, a flange) to stop flow through the aspiration handpiece 1094, which can include isolating the aspiration tube from the vacuum force of the vacuum line 1074 with the obstruction 1096. The valve 1104 can include a fluid opening 1095 (e.g., a flow path) to allow flow through the aspiration handpiece 1094, which can include fluidly connecting the aspiration tube with the vacuum force of the vacuum line 1074. The valve 1104 can include a spring 1098 (e.g., a resilient member). The spring 1098 can bias the valve 1104 to position the obstruction 1096 in the inlet line 1070 and stop flow through the aspiration handpiece 1094. The aspiration handpiece 1094 can include a user interface 1060 (e.g., a toggle, switch, button, dial, slider, etc.) that can be interacted with (e.g., pushed, pulled, compressed, rotated, etc.) to overcome the biasing force of the spring 1098 and position the fluid opening 1095 in the inlet line 1070 to permit flow through the aspiration handpiece 1094 (e.g., fluidly connecting the aspiration tube with the vacuum force of the vacuum line 1074).

[0362] The vacuum line 1074 can include a vacuum canister 1086 (e.g., separator canister, container), a vacuum regulator 1088, a vacuum gauge 1090, and / or a vacuum source 1092 (e.g., wall vacuum, pump). The vacuum source 1092 can provide vacuum force to aspirate material using an aspiration handpiece 1094. The vacuum canister 1086 can collect material aspirated by the aspiration handpiece 1094 (e.g., fluid, emulsified crystals 112, etc.). The vacuum regulator 1088 can maintain a vacuum pressure that can be selectively adjusted. The vacuum gauge 1090 can indicate the vacuum pressure in the vacuum line 1074.

[0363] FIG. 40 illustrates an aspiration system 1068, which may include features of an aspiration system 1069. The aspiration system 1068 may include a valve 1072 (e.g., a spring valve). The valve 1072 may stop or allow vacuum suction (e.g., suction) from a vacuum line 1074 that draws material through an aspiration tube disposed within the lens capsule 110. The valve 1072 may include a first fluid opening 1100 (e.g., a flow path) and a second fluid opening 1102 (e.g., a flow path). The valve 1072 may include a spring 1078 that biases the first fluid opening 1100 into a configuration that fluidly connects the inlet line 1070 with a relief line 1076 of the aspiration system 1068. The relief line 1076 may be fluidly coupled to atmospheric pressure 1084 by a relief valve 1080 that may be operated by a spring 1082 (e.g., a biasing member). The aspiration handpiece 1094 can include a user interface 1060 that can be interacted with (e.g., pushed, pulled, compressed, rotated, etc.) to overcome the biasing force of the spring 1078, thereby fluidly coupling the vacuum line 1074 with the inlet line 1070 via the second fluid opening 1102 and aspirating material using the aspiration tube.

[0364] 41A-41C show schematic diagrams of irrigation handpiece 1108 having temperature sensors in different locations. Irrigation handpiece 1108 can be any of and / or include any of the features of irrigation handpieces described herein (e.g., irrigation handpiece 1000, irrigation handpiece 1022, irrigation handpiece 1040).

[0365] 41A, the second fluid line 1048 can be disposed around a heater 1050 (e.g., a cartridge heater) to facilitate heat transfer from the heater 1050 to the fluid in the second fluid line 1048. For example, the second fluid line 1048 can be wrapped around the heater 1050. The second fluid line 1048 can be coiled around the heater 1050.

[0366] The irrigation handpiece 1108 can include a valve 1112 (e.g., a spring valve). The valve 1112 can include an opening 1116 (e.g., a flow path). The opening 1116 can be positioned to fluidly connect the irrigation tubing 1002 with the first fluid line 1046 or the second fluid line 1048. The valve 1112 can include a spring 1122 (e.g., a resilient member) that biases the opening 1116 into position in the first fluid line 1046, fluidly connecting the first fluid line 1046 with the irrigation tubing 1002, such that fluid flows through the irrigation handpiece 1108 without being routed to the heater 1050. An obstruction 1120 (e.g., a barrier, flange, wall) of the valve 1112 can be positioned in the second fluid line 1048 to block flow.

[0367] The user interface 1060 can be interacted with (e.g., pushed) to overcome the biasing force of the spring 1122 and position the opening 1116 in the second fluid line 1048, fluidly connecting the second fluid line 1048 with the irrigation tubing 1002, such that fluid heated by the heater 1050 flows out one or more outlets 1006 of the irrigation tubing 1002 and emulsifies the lens 112. An obstruction 1118 (e.g., a barrier, flange, wall) of the valve 1112 can be placed in the first fluid line 1046 to block the flow.

[0368] The irrigation handpiece 1108 can include one or more temperature sensors (e.g., thermocouples) that can be used to monitor the temperature throughout the irrigation handpiece 1108. The sensed temperature can be used to control the energy output by the heater 1050 to maintain the temperature of the heated fluid at the outlet 1006 of the irrigation tubing 1002 within a specific range. The temperature sensor can trigger a safety protocol if an unsafe temperature is detected, which can include reducing the energy output by the heater 1050, issuing an alarm notification, and / or stopping the flow of fluid in the second fluid line 1048.

[0369] The irrigation handpiece 1108 can include a temperature sensor 1128 at the outlet 1006 to monitor the temperature at which the heated fluid is delivered to the lens 112 for emulsification. The irrigation handpiece 1108 can include a temperature sensor 1126 in the second fluid line 1048 before the irrigation tubing 1002, which can include a temperature sensor 1126 downstream of the heater 1050 and upstream of the valve 1112. If the temperature sensed at the outlet 1006 is below a threshold, the energy output by the heater 1050 can be increased. In some variations, a comparison between the temperatures sensed by the temperature sensor 1128 and the temperature sensor 1126 can be used to determine heat loss from the heater 1050 to the outlet 1006. As shown in FIG. 41B , in some variations, the temperature sensor 1126 can be located in the second fluid line 1048 upstream of the heater 1050, which can help inform the amount of energy the heater 1050 should apply to the second fluid line 1048. 41C, in some variations, a temperature sensor 1126 can be placed in the second fluid line 1048 of the heater 1050. A temperature sensor 1130 can be placed in the inlet line 1042 upstream of the split between the first fluid line 1046 and the second fluid line 1048, which can provide information regarding the amount of energy that the heater 1050 should apply to the second fluid line 1048 to raise the temperature of the fluid in the second fluid line 1048 to a target range before heating the fluid.

[0370] 42 shows a temperature sensor 1128 positioned at one or more of the outlets 1006. As shown, the temperature sensor 1128 can be positioned within the lumen 1003 (e.g., cavity, interior) of the irrigation tubing 1002 at one or more of the outlets 1006, thereby facilitating monitoring of the temperature of the heated fluid at the point of delivery to the lens 112. A conduit 1130 (e.g., wire) for the temperature sensor 1128 can be routed through the lumen 1003 to communicate temperature data to the irrigation handpiece and / or a console (e.g., a computing device) with which the irrigation handpiece is in communication.

[0371] 43A shows a pole 1138 (e.g., support, structure, IV pole), vacuum canister 1086, vacuum source interface 1092, and / or console 1140 that can support an irrigation and / or aspiration handpiece described herein. The pole 1138 can support a reservoir 1044. The reservoir 1044 can be positioned at an elevation that promotes flow to an irrigation handpiece fluidly connected to the reservoir 1044. The vacuum canister 1086 can be positioned on the pole 1138. FIG. 43B shows the console 1140, which may include a display 1148 (e.g., a touch screen), a power switch 1142 (e.g., an on / off switch), a port 1146 (e.g., an interface) for connecting with the cable 1012, and a user interface 1144 (e.g., a dial, toggle, button, switch, slider, etc.) that can be used to control the console 1140, such as the electrical energy delivered to the console 1140.

[0372] 44A and 44B show irrigation tube 1002 and aspiration tube 1026 positioned to emulsify and aspirate lens 112 positioned within lens capsule 110 of eye 100. Incisions can be made in cornea 102 and lens capsule 110 to place irrigation tube 1002 and aspiration tube 1026 on lens 112.

[0373] In some variations, a capsulorhexis can be performed to access the lens 112, which can include performing a smaller capsulorhexis at 2-3 millimeters. In some variations, the capsulorhexis can be performed off the visual axis of the eye 100, which can include performing it outside the optical zone.

[0374] In some variations, as shown in FIG. 44A , capsulorhexis is not performed. The irrigation tube 1002 can be advanced through an opening 1150 (e.g., a slit, punch, or hole) in the cornea 102 and an opening 1154 (e.g., a slit, punch, or hole) in the capsular bag 110. The suction tube 1026 can be advanced through an opening 1152 (e.g., a slit, punch, or hole) in the cornea 102 and an opening 1156 (e.g., a slit, punch, or hole) in the capsular bag 110. The openings 1150, 1152, 1154, and 1156 can be cut (e.g., scored). The openings 1150, 1152, 1154, and 1156 can be positioned off the visual axis of the eye 100, which can include being located outside the optical zone. The openings 1150, 1152, 1154, and 1156 can include sizes of 0.1 to 3.0 millimeters, 1.0 to 2.5 millimeters, or less than 2.0 millimeters. These small opening sizes can be used in consideration of reduced sizes (e.g., diameters) of the irrigation tube 1002 and / or aspiration tube 1026, which can include diameters of corresponding sizes. With the irrigation tube 1002 and aspiration tube 1026 positioned, the heated fluid 1158 can be delivered to the lens 112 for emulsification through one or more outlets 1006 of the irrigation tube 1002. One or more inlets 1028 of the aspiration tube 1026 can be positioned adjacent to and / or facing one or more outlets 1006 to rapidly aspirate the heated fluid and emulsified lens and aid in localizing the heat. The irrigation tube 1002 and / or aspiration tube 1026 can be positioned at or near the nucleus of the lens 112 at the beginning of emulsification, which can help localize heat within the lens capsule 110. As described herein, the irrigation tube 1002 can deliver fluid for irrigation that is not heated by the heater 1050, if desired. The temperature of the heated fluid at one or more outlets 1006 can be any temperature described herein. The temperature can be monitored by one or more temperature sensors, which can guide the control of the heater that heats the fluid.The lens 112 can be completely emulsified and aspirated in under two minutes using the irrigation tubing 1002 and aspiration tubing 1026 while leaving the lens capsule 110 intact for implantation of the intraocular lens. The flow rates of the heated fluid and vacuum can also be low. In some variations, phacoemulsification techniques are not used.

[0375] (term) Although the systems and methods are disclosed in the context of particular embodiments and examples, it will be understood by those skilled in the art that the systems and methods extend beyond the specifically disclosed embodiments to the use of other alternative embodiments and / or embodiments, as well as certain modifications and equivalents thereof. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various modes of the thermal systems, devices, and methods disclosed herein. The scope of the present disclosure should not be limited by the particular embodiments described and disclosed herein.

[0376] Included are methods of using the aforementioned systems (including devices, apparatus, assemblies, structures, etc.), which may include using or assembling any one or more of the features disclosed herein to achieve the functions and / or characteristics of the systems as discussed in this disclosure. Included are methods of manufacturing the aforementioned systems, which may include providing, making, connecting, assembling, and / or installing any one or more of the features of the systems disclosed herein to achieve the functions and / or characteristics of the systems as discussed in this disclosure.

[0377] Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, while features may be described above as working in a particular combination, one or more features from a claimed combination can, in some cases, be excluded from that combination, and the combination can be claimed as any subcombination or a variation of any subcombination.

[0378] Furthermore, while operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown or in sequential order to achieve desired results, and not all operations need be performed. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Moreover, operations may be rearranged or reordered in other implementations. Also, the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged in multiple products. Moreover, other implementations are within the scope of this disclosure.

[0379] Conditional language such as "can," "possible," "could," or "may," unless expressly stated otherwise or interpreted otherwise within the context of use, is generally intended to convey that particular embodiments include or do not include particular features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that a feature, element, and / or step is in some way required in one or more embodiments.

[0380] Unless otherwise specified, conjunctive language such as "at least one of X, Y, and Z" is understood in the context in which it is generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0381] Several embodiments have been described in connection with the accompanying drawings. Components may be added, removed, and / or rearranged. For example, orientation references such as "top" and "bottom" are for ease of description and may be rearranged so that top features are proximate the bottom and bottom features are proximate the top. Furthermore, any particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. disclosed herein relating to various embodiments can be used in all other embodiments described herein. Furthermore, it will be recognized that any method described herein may be implemented using any device suitable for performing the recited steps.

[0382] In summary, various embodiments and examples of thermal systems, devices, and methods have been disclosed. While the systems and methods have been disclosed in the context of those embodiments and examples, it will be understood by those skilled in the art that the disclosure extends beyond the specifically disclosed embodiments to the use of other alternative and / or other embodiments, as well as certain modifications and equivalents thereof. The disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with or substituted for one another. The scope of the disclosure should not be limited by the particular disclosed embodiments described above, but should be determined solely by a fair reading of the following claims.

Claims

1. 1. An irrigation device comprising: a tube having an outlet; a temperature sensor disposed at the outlet; a heater configured to heat the fluid flowing through the irrigation device so that the temperature of the fluid at the outlet is within a specified range; Equipped with An irrigation device, wherein the outlet of the tube is configured to be directed toward a lens within a lens capsule of the eye to emulsify the lens.

2. The irrigation device of claim 1 , wherein the specified range is 68 to 70° C.

3. The irrigation device of claim 1 or 2, further comprising a first fluid line that bypasses the heater and passes through the irrigation device.

4. The irrigation device of claim 3 , further comprising a second fluid line passing through the irrigation device and wrapped around the heater.

5. The irrigation device of claim 4 , further comprising a valve configured to direct the fluid flow through the first fluid line or the second fluid line.

6. The irrigation device of claim 5 , wherein the valve comprises a spring that biases the valve into a configuration that directs the flow of the fluid through the first fluid line.

7. 7. The irrigation device of claim 6, further comprising a user interface configured to operate to overcome the biasing force of the spring to position the valve in another configuration that directs the flow of the fluid through the second fluid line.

8. An irrigation device according to any preceding claim, wherein the temperature sensor is disposed within the lumen of the tube.

9. 1. An irrigation device comprising: a tube having an outlet configured to deliver fluid to a lens within the lens capsule of the eye; a first fluid line; a second fluid line; a heater configured to heat the fluid flowing through the second fluid line; a valve configured to direct the fluid through the first fluid line to bypass the heater or through the second fluid line for heating; 1. An irrigation device comprising:

10. 10. The irrigation device of claim 9, wherein the heater is configured to heat the fluid so that the temperature of the fluid exiting the outlet is between 68 and 70 degrees Celsius.

11. 11. The irrigation device of claim 9 or 10, wherein the valve is biased to direct the fluid through the first fluid line.

12. The irrigation device of claim 11 , further comprising a user interface configured to operate to overcome the bias of the valve to direct the fluid through the second fluid line.

13. An irrigation device according to any one of claims 9 to 12, wherein the second fluid line is coiled around the heater.

14. An irrigation device according to any one of claims 9 to 13, further comprising a temperature sensor located at the outlet.

15. The irrigation device of claim 14 , wherein the heater is configured to adjust its energy output based on the temperature sensed by the temperature sensor.

16. 1. An irrigation device comprising: a tube having an outlet configured to deliver fluid to a lens within the lens capsule of the eye; a heater configured to heat the fluid so that the temperature of the fluid at the outlet is between 68 and 70°C; 1. An irrigation device comprising:

17. 17. The irrigation device of claim 16, further comprising a temperature sensor at the outlet, the heater configured to adjust energy output based on the temperature of the fluid at the outlet.

18. 18. An irrigation device according to claim 16 or 17, comprising a fluid line wrapped around the heater.

19. 1. A method for removing a lens within a capsule, comprising: positioning an outlet of an irrigation tube of an irrigation device at the nucleus of the lens within the lens capsule; positioning an inlet of a suction tube of a suction device adjacent to the outlet of the irrigation tube; delivering a fluid heated to 68-70°C to the lens to emulsify the lens; aspirating the heated fluid and emulsified lens from the eye; A method comprising:

20. 20. The method of claim 19, further comprising heating a fluid and adjusting the heating of the fluid based on a sensed temperature of the heated fluid at the outlet of the irrigation tube.

21. 1. A thermal system for removing a lens from an eye, comprising: a distal tip including a suction opening and a heating element, the distal tip configured to be inserted into the eye to position the heating element on the lens; a power source configured to direct electrical energy to the heating element to increase the temperature of the heating element; Equipped with The system, wherein the heating element is configured to emulsify the lens.

22. 22. The system of claim 21, further comprising an irrigation port configured to irrigate a fluid within the eye.

23. 23. The system of claim 21 or 22, wherein the heating element is disposed around the suction opening.

24. The system of any one of claims 21 to 23, wherein the heating element comprises a ring shape.

25. A system according to any one of claims 21 to 24, wherein the heating element comprises a plurality of separate elements distributed circumferentially around the suction opening.

26. The system of any one of claims 21 to 25, wherein the heating element is disposed on a distal-facing surface of the distal tip.

27. 23. The system of any one of claims 21 and 22, wherein the heating element is retractable.

28. 28. The system of any one of claims 21, 22, and 27, wherein the heating element is configured to oscillate.

29. 29. The system of any one of claims 21, 22, 27, and 28, wherein the heating element is configured to vibrate.

30. 30. The system of any one of claims 21, 22 and 27-29, wherein the heating element comprises a sharp tip.

31. The system of any one of claims 21, 22 and 27-30, wherein the heating element comprises a cutting edge.

32. The system of any one of claims 21, 22, and 27-31, wherein the heating element comprises a wire.

33. The system of any one of claims 21, 22, and 27-32, wherein the heating element comprises a wire forming a loop.

34. The system of any one of claims 21, 22 and 27-33, wherein the heating element comprises a plurality of wires forming a plurality of loops.

35. The system of any one of claims 21, 22 and 7-12, wherein the heating element comprises a mesh.

36. The system of any one of claims 21 to 35, further comprising a receptacle for receiving the aspirated lens.

37. The system of any one of claims 21 to 36, wherein the distal end of the tip is angled.

38. 38. The system of any one of claims 21 to 37, further comprising an insulating material for protecting the eye.

39. A system according to any one of claims 21 to 38, wherein the temperature of the heating element is configured to vary cyclically.

40. 40. The system of any one of claims 21 to 39, wherein the heating element comprises a nickel and titanium alloy.

41. 41. The system of any one of claims 21 to 40, wherein the power supply is configured to direct electrical energy to the heating element to raise the temperature of the heating element to 64-70°C.

42. 42. The system of any one of claims 21 to 41, wherein the power supply is configured to direct electrical energy to the heating element to raise the temperature of the heating element to 68-70°C.

43. 43. The system of any one of claims 21 to 42, wherein the power supply is configured to direct electrical energy to the heating element to heat the lens to 64-70°C.

44. 44. The system of any one of claims 21 to 43, wherein the power supply is configured to direct electrical energy to the heating element to heat the lens to 68-70°C.

45. The system of any one of claims 21 to 44, wherein the heating element is configured to soften the lens.

46. The system of any one of claims 21 to 45, wherein the heating element is configured to emulsify the lens.

47. The system of any one of claims 21 to 46, wherein the system is a portable handheld device.

48. 1. A thermal system for cataract surgery, the system comprising a tip having a temperature control element, the tip configured to be inserted into an eye and position the temperature control element on a lens of the eye, the temperature control element configured to heat the lens.

49. 49. The system of claim 48, further comprising an energy source configured to direct energy to the temperature control element to increase the temperature of the temperature control element.

50. 50. The system of claim 49, wherein the energy source is a battery.

51. The system of any one of claims 48 to 50, wherein the temperature control element comprises a thermally conductive material.

52. 52. The system of any one of claims 48 to 51, further comprising a suction opening configured to suction the heated lens.

53. 53. The system of any one of claims 48 to 52, wherein the temperature control element is configured to heat the lens to soften it.

54. 54. The system of any one of claims 48 to 53, wherein the temperature control element is configured to heat the lens to emulsify the lens.

55. 55. The system of any one of claims 48 to 54, wherein the temperature control element is configured to heat the lens to a glass transition temperature.

56. 56. The system of any one of claims 48 to 55, wherein the temperature control element is configured to heat the crystal to a melting temperature.

57. 57. The system of any one of claims 48 to 56, wherein the temperature control element is configured to reach 64 to 70°C.

58. 57. The system of any one of claims 48 to 56, wherein the temperature control element is configured to reach 68-70°C.

59. 57. The system of any one of claims 48 to 56, wherein the temperature control element is configured to heat the lens to 64-70°C.

60. 57. The system of any one of claims 48 to 56, wherein the temperature control element is configured to heat the lens to 64-70°C.

61. 61. The system of any one of claims 48 to 60, further comprising an irrigation port.

62. The system of any one of claims 28 to 41, wherein the temperature control element is located on a distal facing surface of the tip.

63. The system of any one of claims 48 to 62, wherein the temperature control element is retractable.

64. A system according to any one of claims 48 to 63, wherein the temperature control element is configured to oscillate.

65. The system of any one of claims 48 to 64, wherein the temperature control element is configured to vibrate.

66. The system of any one of claims 48 to 65, wherein the temperature control element comprises a sharp tip.

67. 67. The system of any one of claims 48 to 66, wherein the temperature control element comprises a cutting edge.

68. 68. The system of any one of claims 48 to 67, wherein the temperature control element comprises a wire.

69. 68. The system of any one of claims 48 to 67, wherein the temperature control element comprises a wire forming a loop.

70. 68. The system of any one of claims 48 to 67, wherein the temperature control element comprises a plurality of wires forming a plurality of loops.

71. 68. The system of any one of claims 48 to 67, wherein the temperature control element comprises a mesh.

72. 72. The system of any one of claims 48 to 71, further comprising a receptacle for receiving the aspirated lens.

73. The system of any one of claims 48 to 72, wherein the distal end of the tip is angled.

74. 74. The system of any one of claims 48 to 73, further comprising an insulating material for protecting the eye.

75. 75. The system of any one of claims 48 to 74, wherein the temperature control element comprises a nickel and titanium alloy.

76. The system of any one of claims 48 to 74, wherein the system is a portable handheld device.

77. A temperature control element connected to an energy source, the energy source configured to direct energy to the temperature control element to increase the temperature of the temperature control element, the temperature control element being disposed on a suction device and positioned on a lens and configured to heat the lens.

78. 78. The temperature control element of claim 77, wherein the energy source is a battery.

79. 79. The temperature control element of claim 77 or 78, wherein the temperature control element comprises a conductive material.

80. 80. A temperature control element according to any one of claims 77 to 79, wherein the temperature control element is configured to heat the lens to soften it.

81. A temperature control element according to any one of claims 77 to 80, wherein the temperature control element is configured to heat the lens to emulsify the lens.

82. 82. A temperature control element according to any one of claims 77 to 81, wherein the temperature control element is configured to heat the crystalline lens to 64-70°C.

83. 82. A temperature control element according to any one of claims 77 to 81, wherein the temperature control element is configured to heat the crystalline lens to 68-70°C.

84. A temperature control element according to any one of claims 77 to 83, wherein the temperature control element comprises a wire.

85. 1. A method for removing a lens, comprising: inserting a distal end of the thermal system into the eye to position the temperature control element on the lens; applying energy to the temperature control element to heat the lens; aspirating the heated lens; A method comprising:

86. 86. The method of claim 85, wherein applying energy to the temperature control element to heat the lens comprises raising the temperature of the lens to 64-70°C.

87. 86. The method of claim 85, wherein applying energy to the temperature control element to heat the lens comprises raising the temperature of the lens to 68-70°C.

88. 86. The method of claim 85, wherein applying energy to the temperature control element to heat the lens comprises raising the temperature of the lens to 66-70°C.

89. 89. The method of any one of claims 85 to 88, wherein the energy is electrical energy.

90. 25. The system of any one of claims 21 to 24, wherein the power supply is configured to direct electrical energy to the heating element to raise the temperature of the heating element to 66-70°C.

91. 57. The system of any one of claims 48 to 56, wherein the temperature control element is configured to reach 66-70°C.

92. 82. A temperature control element according to any one of claims 77 to 81, wherein the temperature control element is configured to heat the crystalline lens to 66-70°C.

93. 1. A method for removing a lens, comprising: passing a fluid at 64-70°C over the lens of the eye to emulsify the lens; aspirating the emulsified lens from the eye; A method comprising:

94. 94. The method of claim 93, wherein the fluid is at 66-70°C.

95. 94. The method of claim 93, wherein the fluid is at 68-70°C.

96. 96. The method of any one of claims 93 to 95, further comprising cutting the lens capsule of the eye to access the lens.

97. 97. The method of claim 96, wherein cutting the lens capsule of the eye comprises flowing the fluid through the lens capsule to cut the lens capsule.

98. 98. The method of any one of claims 93 to 97, further comprising the steps of introducing an irrigation cannula into the eye and introducing an aspiration cannula into the eye, the irrigation cannula configured to flush the fluid into the lens and the aspiration cannula configured to aspirate the emulsified lens from the eye.

99. 99. The method of claim 98, further comprising positioning the irrigation cannula and the aspiration cannula on opposite sides of an optical axis so that an opening of the irrigation cannula faces an opening of the aspiration cannula.

100. 99. The method of claim 98, wherein the irrigation cannula and the aspiration cannula are juxtaposed to one another such that the axes of the irrigation cannula and the aspiration cannula are parallel to one another.

101. 99. The method of claim 98, wherein the irrigation cannula is positioned inside the aspiration cannula.

102. 102. The method of claim 101, further comprising the step of advancing a member through the irrigation cannula to engage the lens.

103. 103. The method of claim 102, further comprising the step of heating the member.

104. 104. The method of claim 102 or 103, wherein the member is a wire.

105. 102. The method of claim 101, wherein the irrigation cannula comprises a closed end having one or more openings disposed through a sidewall.

106. 106. The method of claim 105, wherein the closed end comprises a curved periphery.

107. 107. The method of claim 105 or 106, wherein the closed end comprises a curved inner surface.

108. 102. The method of claim 98 or 101, wherein the irrigation cannula comprises a curved portion configured to redirect the fluid flow from a distal direction to a proximal direction.

109. 109. The method of claim 108, wherein the irrigation cannula includes an opening facing in the proximal direction.

110. 105. The method of any one of claims 98 to 104, wherein the irrigation cannula comprises a flared portion that gradually increases the internal lumen of the irrigation cannula to an opening.

111. 105. The method of any one of claims 98 to 104, wherein the irrigation cannula comprises a cutting edge disposed at a distal end.

112. 99. The method of claim 98, wherein the aspiration cannula is positioned inside the irrigation cannula.

113. 113. The method of claim 112, wherein the aspiration cannula comprises a closed end having one or more openings disposed in a sidewall.

114. A method according to any one of claims 98 to 111, wherein the aspiration cannula is provided with a cutting edge.

115. 115. The method of claim 114, wherein the cutting edge is disposed around the distal opening of the aspiration cannula.

116. 116. The method of any one of claims 98 to 115, wherein the aspiration cannula comprises a flared distal end.

117. 1. A thermal system for cataract surgery, comprising: a tip configured to deliver a fluid at 64-70°C to the lens of the eye to emulsify the lens; an opening configured to aspirate the emulsified lens from the eye; A system comprising:

118. 118. The system of claim 117, wherein the fluid is at 66-70°C.

119. 118. The system of claim 117, wherein the fluid is at 68-70°C.

120. The system of any one of claims 117 to 119, wherein the system is a handheld device.

121. The system of any one of claims 117 to 119, wherein the system is retrofitted to a phaco machine.

122. 122. The system of any one of claims 117 to 121, further comprising a fluid reservoir for holding the fluid prior to delivery.

123. 123. The system of any one of claims 117 to 122, further comprising a heating element configured to heat the fluid.

124. The system of any one of claims 117 to 123, further comprising a temperature sensor.

125. 121. The system of claim 120, wherein the temperature sensor is at the tip.

126. 125. The system of claim 124, wherein the heating element is configured to adjust the temperature of the fluid based on the temperature detected by the temperature sensor.

127. The system of any one of claims 117 to 126, further comprising a pump.

128. 128. The system of any one of claims 117 to 127, further comprising a valve configured to prevent delivery of the fluid.

129. 129. The system of any one of claims 117 to 128, further comprising a waste reservoir configured to hold aspirated material.

130. A thermal system for cataract surgery, the system comprising a heating element configured to heat a fluid and deliver it to a lens of the eye at 64-70°C to emulsify the lens.

131. 131. The system of claim 130, wherein the heating element is configured to heat the fluid and deliver it to the lens of the eye at 66-70°C.

132. 131. The system of claim 130, wherein the heating element is configured to heat the fluid and deliver it to the lens of the eye at 68-70°C.

133. 131. The system of claim 130, further comprising a fluid reservoir.

134. 134. The system of claim 133, wherein the heating element is configured to heat the fluid in the fluid reservoir.

135. 135. A system according to any one of claims 130 to 134, further comprising a temperature sensor, the heating element being configured to adjust the temperature of the fluid based on feedback from the temperature sensor.

136. 1. A thermal system for cataract surgery, comprising: an irrigation cannula configured to deliver a fluid at 64-70°C to the lens of the eye to emulsify said lens; an aspiration cannula configured to aspirate the emulsified lens from the eye; A system comprising:

137. 137. The system of claim 136, wherein the irrigation cannula is configured to deliver the fluid at 66-70 degrees Celsius.

138. 137. The system of claim 136, wherein the irrigation cannula is configured to deliver the fluid at 68-70 degrees Celsius.

139. A system according to any one of claims 136 to 138, wherein the irrigation cannula and the suction cannula are configured to be positioned on opposite sides of the optical axis, with the opening of the irrigation cannula facing the opening of the suction cannula.

140. 139. A system according to any one of claims 136 to 138, wherein the irrigation cannula and the aspiration cannula are configured to be juxtaposed to one another such that the axes of the irrigation cannula and the aspiration cannula are parallel to one another.

141. The system of any one of claims 136 to 138, wherein the irrigation cannula is positioned inside the suction cannula.

142. 142. The system of any one of claims 136 to 141, further comprising a member configured to be advanced through the irrigation cannula to engage the lens.

143. 143. The system of claim 142, wherein the member is configured to be heated.

144. 144. The system of claim 142 or 143, wherein the member is a wire.

145. 142. The system of any one of claims 136 to 141, wherein the irrigation cannula comprises a closed end having one or more openings disposed through a side wall.

146. 146. The system of claim 145, wherein the closed end comprises a curved periphery.

147. 147. The system of claim 145 or 146, wherein the closed end comprises a curved inner surface.

148. 148. The system of any one of claims 136 to 147, wherein the irrigation cannula comprises a curved portion configured to redirect the fluid flow from a distal direction to a proximal direction.

149. 149. The system of claim 148, wherein the irrigation cannula includes an opening facing proximally.

150. 150. The system of any one of claims 136 to 149, wherein the irrigation cannula comprises a flared portion that gradually increases the internal lumen of the irrigation cannula to an opening.

151. The system of any one of claims 136 to 150, wherein the irrigation cannula includes a cutting edge disposed at a distal end.

152. 137. The system of claim 136, wherein the aspiration cannula is positioned inside the irrigation cannula.

153. 153. The system of claim 152, wherein the suction cannula comprises a closed end having one or more openings disposed in a sidewall.

154. The system of any one of claims 136 to 152, wherein the suction cannula comprises a cutting edge.

155. 155. The system of claim 154, wherein the cutting edge is disposed around the distal opening of the aspiration cannula.

156. The system of any one of claims 136 to 152, wherein the suction cannula has a flared distal end.

Images